20-F 1 a19-3375_120f.htm 20-F

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SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

o | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
x | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
| For the transition period from to
o | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report . . . . . . . . . . . . . . . . . . .

Commission file number 001-35193

GRIFOLS, S.A.
(Exact name of Registrant as specified in its charter)
Kingdom of Spain
(Jurisdiction of incorporation)
Avinguda de la Generalitat, 152-158 Parc de Negocis Can Sant Joan Sant Cugat del Vallès 08174 Barcelona, Spain
(Address of principal executive offices)
David Ian Bell General Counsel Grifols Shared Services North America, Inc. 2410 Lillyvale Ave Los Angeles, CA 90032-3514
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered, pursuant to Section 12(b) of the Act.

Title of each class |  | Name of each exchange on which registered
American Depositary Shares evidenced by American Depositary Receipts, each American Depositary Share representing one Class B non-voting share of Grifols, S.A. |  | The NASDAQ Stock Market LLC

Securities registered or to be registered pursuant to Section 12(g) of the Act.

None.
(Title of Class)

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Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

None.
(Title of Class)

Indicate the number of outstanding shares of each of the issuer’s classes of capital stock or common stock as of the close of the period covered by the annual report.

| 426,129,798 Class A Shares
| 261,425,110 Class B Shares

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

x Yes o No

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

o Yes x No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

x Yes o No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

x Yes o No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer x |  | Accelerated filer o |  | Non-accelerated filer o |  | Emerging growth company o

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. o

†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP o |  | International Financial Reporting Standards as issued by the International Accounting Standards Board x |  | Other o

If “Other” has been checked in response to the previous question indicate by check mark which financial statement item the registrant has elected to follow.

o Item 17 o Item 18

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

o Yes x No

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GRIFOLS, S.A.

TABLE OF CONTENTS

|  | Page
PRESENTATION OF FINANCIAL AND OTHER INFORMATION | iii
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS | iv
PART I |  | 1
Item 1. | IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS | 1
Item 2. | OFFER STATISTICS AND EXPECTED TIMETABLE | 1
Item 3. | KEY INFORMATION | 1
Item 4. | INFORMATION ON THE COMPANY | 28
Item 4.A. | UNRESOLVED STAFF COMMENTS | 66
Item 5. | OPERATING AND FINANCIAL REVIEW AND PROSPECTS | 66
Item 6. | DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES | 95
Item 7. | MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS | 109
Item 8. | FINANCIAL INFORMATION | 112
Item 9. | THE OFFER AND LISTING | 114
Item 10. | ADDITIONAL INFORMATION | 120
Item 11. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 139
Item 12. | DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES | 140
PART II |  | 145
Item 13. | DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES | 145
Item 14. | MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS | 145
Item 15. | CONTROLS AND PROCEDURES | 145
Item 16. | [RESERVED] | 147
Item 16.A. | AUDIT COMMITTEE FINANCIAL EXPERT | 147
Item 16.B. | CODE OF ETHICS | 147
Item 16.C. | PRINCIPAL ACCOUNTANT FEES AND SERVICES | 147
Item 16.D. | EXEMPTION FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES | 148

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|  | Page
Item 16.E. | PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS | 148
Item 16.F. | CHANGES IN REGISTRANT’S CERTIFYING ACCOUNTANT | 148
Item 16.G. | CORPORATE GOVERNANCE | 148
Item 16.H. | MINE SAFETY DISCLOSURE | 151
PART III |  | 152
Item 17. | FINANCIAL STATEMENTS | 152
Item 18. | FINANCIAL STATEMENTS | 152
Item 19. | EXHIBITS | 152

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GENERAL INFORMATION

As used in this annual report on Form 20-F, unless the context otherwise requires or as is otherwise indicated:

· all references to “Grifols,” the “Company,” “we,” “us” and “our” refer to Grifols, S.A., a company (sociedad anónima) organized under the laws of Spain, and our consolidated subsidiaries; and

· all references to the “Group” or the “Grifols Group” are to Grifols, S.A. and the group of companies owned or controlled by Grifols, S.A.

PRESENTATION OF FINANCIAL AND OTHER INFORMATION

The basis of presentation of financial information of Grifols in this document is in conformity with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB and other legislative provisions containing the applicable legislation governing our financial information, unless indicated otherwise.

All references in this annual report on Form 20-F to (i) “euro”, “€” or “EUR” are to the common currency of the European Union and (ii) “U.S. dollar”, “$” or “USD” are to the currency of the United States.

All tabular disclosures are presented in thousands of euro except share and per share amounts, percentages and as otherwise indicated. Certain monetary amounts and other figures included in this annual report on Form 20-F have been subject to rounding adjustments. Accordingly, any discrepancies in any tables between the totals and the sums of amounts listed are due to rounding.

Constant Currency

Net revenue variance in constant currency is determined by comparing adjusted current period figures, calculated using prior period monthly average exchange rates, to the prior period net revenue. The resulting percentage variance in constant currency is considered to be a non-IFRS-IASB financial measure. Net revenue variance in constant currency calculates net revenue variance without the impact of foreign exchange fluctuations. We believe that constant currency variance is an important measure of our operations because it neutralizes foreign exchange impact and illustrates the underlying change from one year to the next. We believe that this presentation provides a useful period-over-period comparison as changes due solely to exchange rate fluctuations are eliminated. Net revenue variance in constant currency, as defined and presented by us, may not be comparable to similar measures reported by other companies. Net revenue variance in constant currency has limitations, particularly because the currency effects that are eliminated constitute a significant element of our net revenue and expenses and could impact our performance significantly. We do not evaluate our results and performance without considering variances in constant currency on the one hand and changes prepared in accordance with IFRS-IASB on the other. We caution you to follow a similar approach by considering data regarding constant currency period-over-period revenue variance only in addition to, and not as a substitute for or superior to, other measures of financial performance prepared in accordance with IFRS-IASB. We present the fluctuation derived from IFRS-IASB net revenue next to the fluctuation derived from non IFRS-IASB net revenue.

See below for a reconciliation of reported net revenues to net revenues in constant currency:

|  | 2018 |  | 2017 |  | % var |  |  |  | 2017 |  | 2016 |  | % var |
|  | (in millions of euros) |  |  |  |  |  | (in millions of euros) |  |  |
Reported Net Revenues |  | 4,486.7 |  | 4,318.1 |  | 3.9 | % | Reported Net Revenues |  | 4,318.1 |  | 4,049.8 |  | 6.6 | %
Variation due to exchange rate effects |  | 226.5 |  |  |  |  |  | Variation due to exchange rate effects |  | 25.1 |  |  |  |  |
Constant Currency Net Revenues |  | 4,713.2 |  | 4,318.1 |  | 9.2 | % | Constant Currency Net Revenues |  | 4,343.2 |  | 4,049.8 |  | 7.2 | %

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PRESENTATION OF MARKET INFORMATION

Market information (including market share, market position and industry data for our operating activities and those of our subsidiaries or of companies acquired by us) or other statements presented in this annual report on Form 20-F regarding our position (or that of companies acquired by us) relative to our competitors largely reflect the best estimates of our management. These estimates are based upon information obtained from customers, trade or business organizations and associations, other contacts within the industries in which we operate and, in some cases, upon published statistical data or information from independent third parties. Except as otherwise stated, our market share data, as well as our management’s assessment of our comparative competitive position, has been derived by comparing our sales figures for the relevant period to our management’s estimates of our competitors’ sales figures for such period, as well as upon published statistical data and information from independent third parties, and, in particular, the reports published and the information made available by, among others, the Marketing Research Bureau, or the MRB. You should not rely on the market share and other market information presented herein as precise measures of market share or of other actual conditions.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This annual report contains statements that constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as “may,” “anticipate,” “believe,” “estimate,” “predict,” “expect,” “intend,” “forecast,” “will,” “would,” “should” or the negative of such terms or other variations on such terms or comparable or similar words or expressions.

These forward-looking statements reflect, as applicable, our management’s current beliefs, assumptions and expectations and are subject to a number of factors that may cause actual results to differ materially. These factors include, but are not limited to:

Risks Relating to Our Business:

· the complexity of our manufacturing processes and the susceptibility of our biological intermediates to contamination;

· our need to continually monitor our products for possible unexpected side effects;

· our ability to adhere to government regulations so that we may continue to manufacture and distribute our products;

· the impact of disruptions in our supply of plasma or in the operations of our plasma collection centers;

· the impact of competing products and pricing and the actions of competitors;

· the impact of product liability claims on our business;

· our reliance on a plasma supply free of transmittable disease;

· interest rates and availability and cost of financing opportunities;

· the impact of interest rate fluctuations;

· uncertainty about the value of loans and other financial instruments due to the phasing out and replacement of LIBOR;

· unexpected shut-downs of our manufacturing and storage facilities or delays in opening new planned facilities;

· reliance on third parties for manufacturing of products and provision of services;

· our ability to commercialize products in development;

· uncertainties involved in product research and development, including regarding clinical trials;

· breaches of data security or data privacy, or disruptions in our information technology systems; and

· our ability to protect our intellectual property rights.

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Risks Relating to the Healthcare Industry:

· the impact of the 2010 Patient Protection and Affordable Care Act and companion Healthcare and Education Reconciliation Act, and potential repeal or amendment thereof, new legislation, regulatory action or legal proceedings affecting, among other things, the U.S. healthcare system, pharmaceutical pricing and reimbursement, including Medicaid, Medicare and the Public Health Service Program;

· legislation or regulations in markets outside of the United States affecting product pricing, reimbursement, access, or distribution channels; and

· changes in legal requirements affecting the industries in which we operate.

Please review a more detailed discussion of these and other risks that may impact our business set forth in this Form 20-F under “Item 3.D. Risk Factors.”

Forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those listed above, and actual results may differ materially from those in the forward-looking statements.

The forward-looking statements contained in this annual report speak only as of the date of this annual report. Except as required by law, we do not undertake to update any forward-looking statement to reflect events or circumstances after that date or to reflect the occurrence of unanticipated events.

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PART I

Item 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

A. Directors and Senior Management

Not applicable.

B. Advisers

Not applicable.

C. Auditor

Not applicable.

Item 2. OFFER STATISTICS AND EXPECTED TIMETABLE

A. Offer Statistics

Not applicable.

B. Method and Expected Timetable

Not applicable.

Item 3. KEY INFORMATION

A. Selected Financial Data

Selected Consolidated Financial Information

The following is a summary of our historical consolidated financial data for the periods ended and as of the dates indicated below. You are encouraged to read this information together with Item 5 of this Part I, “Operating and Financial Review and Prospects,” and our audited consolidated financial statements and the accompanying notes included in this annual report on Form 20-F.

The following tables present our consolidated financial data for the periods and as of the dates indicated, prepared in conformity with IFRS, as issued by the IASB. Our consolidated balance sheet data as of December 31, 2018 and 2017 and our consolidated statement of profit and loss data for the years ended December 31, 2018, 2017 and 2016 is derived from our audited consolidated financial statements for those years, which are included in this annual report on Form 20-F. Our consolidated balance sheet data as of December 31, 2016, 2015 and 2014 and our consolidated statement of profit and loss data for the years ended December 31, 2015 and 2014 is derived from our consolidated financial statements for those years, which are not included in this Form 20-F.

|  | As of December 31, |
Consolidated Balance Sheet Data |  | 2018 |  | 2017 |  | 2016 |  | 2015 |  | 2014 |
|  | (in thousands of euros) |
ASSETS |  |  |  |  |  |  |  |  |  |  |
Goodwill |  | 5,209,230 |  | 4,590,498 |  | 3,643,995 |  | 3,532,359 |  | 3,174,732 |
Other intangible assets |  | 1,385,537 |  | 1,269,342 |  | 1,195,302 |  | 1,161,572 |  | 1,068,361 |
Property, plant and equipment |  | 1,951,983 |  | 1,760,053 |  | 1,809,852 |  | 1,644,402 |  | 1,147,782 |
Investments in equity accounted investees |  | 226,905 |  | 219,009 |  | 201,345 |  | 76,728 |  | 54,296 |
Non-current financial assets |  | 107,601 |  | 69,889 |  | 89,545 |  | 30,388 |  | 9,011 |
Deferred tax assets |  | 112,539 |  | 66,157 |  | 67,219 |  | 66,794 |  | 82,445 |
Total non-current assets |  | 8,993,795 |  | 7,974,948 |  | 7,007,258 |  | 6,512,243 |  | 5,536,627 |

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|  | As of December 31, |
Consolidated Balance Sheet Data |  | 2018 |  | 2017 |  | 2016 |  | 2015 |  | 2014 |
|  | (in thousands of euros) |
Inventories |  | 1,949,360 |  | 1,629,293 |  | 1,642,931 |  | 1,431,391 |  | 1,194,057 |
Trade and other receivables: |  |  |  |  |  |  |  |  |  |  |
Trade receivables |  | 269,167 |  | 286,198 |  | 413,656 |  | 362,406 |  | 500,785 |
Other receivables |  | 92,418 |  | 40,681 |  | 42,299 |  | 60,520 |  | 35,370 |
Current income tax assets |  | 42,205 |  | 59,531 |  | 77,713 |  | 60,270 |  | 79,593 |
Trade and other receivables |  | 403,790 |  | 386,410 |  | 533,668 |  | 483,196 |  | 615,748 |
Other current financial assets |  | 53,965 |  | 10,738 |  | 2,582 |  | 1,294 |  | 502 |
Other current assets |  | 42,344 |  | 32,354 |  | 48,324 |  | 31,091 |  | 23,669 |
Cash and cash equivalents |  | 1,033,792 |  | 886,521 |  | 895,009 |  | 1,142,500 |  | 1,079,146 |
Total current assets |  | 3,483,251 |  | 2,945,316 |  | 3,122,514 |  | 3,089,472 |  | 2,913,122 |
Total Assets |  | 12,477,046 |  | 10,920,264 |  | 10,129,772 |  | 9,601,715 |  | 8,449,749 |
EQUITY AND LIABILITIES |  |  |  |  |  |  |  |  |  |  |
Share capital |  | 119,604 |  | 119,604 |  | 119,604 |  | 119,604 |  | 119,604 |
Share premium |  | 910,728 |  | 910,728 |  | 910,728 |  | 910,728 |  | 910,728 |
Reserves |  | 2,441,931 |  | 2,027,648 |  | 1,694,245 |  | 1,371,061 |  | 1,088,337 |
Treasury stock |  | (55,441 | ) | (62,422 | ) | (68,710 | ) | (58,575 | ) | (69,252 | )
Interim dividend |  | (136,747 | ) | (122,986 | ) | (122,908 | ) | (119,615 | ) | (85,944 | )
Profit for the year attributable to the Parent |  | 596,642 |  | 662,700 |  | 545,456 |  | 532,145 |  | 470,253 |
Total Share Capital and Accumulated Results |  | 3,876,717 |  | 3,535,272 |  | 3,078,415 |  | 2,755,348 |  | 2,433,726 |
Available for sale financial assets |  | — |  | 4,926 |  | (5,219 | ) | — |  | — |
Cash flow hedges |  | — |  | — |  | — |  | 3,329 |  | (15,811 | )
Other comprehensive income |  | (554 | ) | (656 | ) | (642 | ) | 3,035 |  | (406 | )
Translation differences |  | 349,391 |  | 89,537 |  | 648,927 |  | 534,491 |  | 240,614 |
Other comprehensive expenses |  | 348,837 |  | 93,807 |  | 643,066 |  | 540,855 |  | 224,397 |
Equity attributable to the Parent |  | 4,225,554 |  | 3,629,079 |  | 3,721,481 |  | 3,296,203 |  | 2,658,123 |
Non-controlling interests |  | 471,050 |  | 4,886 |  | 6,497 |  | 5,187 |  | 4,765 |
Total Equity |  | 4,696,604 |  | 3,633,965 |  | 3,727,978 |  | 3,301,390 |  | 2,662,888 |
LIABILITIES |  |  |  |  |  |  |  |  |  |  |
Grants |  | 11,845 |  | 11,822 |  | 12,196 |  | 13,120 |  | 6,781 |
Provisions |  | 6,114 |  | 5,763 |  | 5,118 |  | 4,980 |  | 6,953 |
Non-current financial liabilities |  | 6,099,463 |  | 5,901,815 |  | 4,712,071 |  | 4,597,654 |  | 4,154,630 |
Deferred tax liabilities |  | 404,398 |  | 388,912 |  | 600,646 |  | 631,565 |  | 538,786 |
Total non-current liabilities |  | 6,523,121 |  | 6,308,312 |  | 5,330,031 |  | 5,247,319 |  | 4,707,150 |
Provisions |  | 80,055 |  | 106,995 |  | 89,588 |  | 123,049 |  | 115,985 |
Current financial liabilities |  | 277,382 |  | 155,070 |  | 230,065 |  | 262,497 |  | 194,726 |
Debts with associates |  | 7,079 |  | — |  | — |  | 443 |  | 3,059 |
Trade and other payables: |  |  |  |  |  |  |  |  |  |  |
Suppliers |  | 561,883 |  | 423,096 |  | 461,073 |  | 409,986 |  | 439,631 |
Other payables |  | 159,816 |  | 141,720 |  | 142,894 |  | 106,171 |  | 90,965 |
Current income tax liabilities |  | 1,917 |  | 6,709 |  | 7,957 |  | 16,196 |  | 87,462 |
Total trade and other payables |  | 723,616 |  | 571,525 |  | 611,924 |  | 532,353 |  | 618,058 |
Other current liabilities |  | 169,189 |  | 144,397 |  | 140,186 |  | 134,664 |  | 147,883 |
Total current liabilities |  | 1,257,321 |  | 977,987 |  | 1,071,763 |  | 1,053,006 |  | 1,079,711 |
Total liabilities |  | 7,780,442 |  | 7,286,299 |  | 6,401,794 |  | 6,300,325 |  | 5,786,861 |
Total Equity and Liabilities |  | 12,477,046 |  | 10,920,264 |  | 10,129,772 |  | 9,601,715 |  | 8,449,749 |

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|  | For the Year Ended December 31, |
Consolidated Statement of Profit and Loss Data |  | 2018 |  | 2017 |  | 2016 |  | 2015 |  | 2014 |
|  | (in thousands of euros, except per share data) |
Continuing Operations |  |  |  |  |  |  |  |  |  |  |
Net revenue |  | 4,486,724 |  | 4,318,073 |  | 4,049,830 |  | 3,934,563 |  | 3,355,384 |
Cost of sales |  | (2,437,164 | ) | (2,166,062 | ) | (2,137,539 | ) | (2,003,565 | ) | (1,656,170 | )
Gross Profit |  | 2,049,560 |  | 2,152,011 |  | 1,912,291 |  | 1,930,998 |  | 1,699,214 |
Research and development |  | (240,661 | ) | (288,320 | ) | (197,617 | ) | (224,193 | ) | (180,753 | )
Selling, general and administration expenses |  | (814,775 | ) | (860,348 | ) | (775,266 | ) | (736,435 | ) | (660,772 | )
Operating Expenses |  | (1,055,436 | ) | (1,148,668 | ) | (972,883 | ) | (960,628 | ) | (841,525 | )
Operating Result |  | 994,124 |  | 1,003,343 |  | 939,408 |  | 970,370 |  | 857,689 |
Finance income |  | 13,995 |  | 9,678 |  | 9,934 |  | 5,841 |  | 3,069 |
Finance costs |  | (293,273 | ) | (263,344 | ) | (244,829 | ) | (240,335 | ) | (225,035 | )
Change in fair value of financial instruments |  | — |  | (3,752 | ) | (7,610 | ) | (25,206 | ) | (20,984 | )
Impairment and gains/(losses) on disposal of financial instruments |  | 30,280 |  | (18,844 | ) | — |  | — |  | (5 | )
Exchange differences |  | (8,246 | ) | (11,472 | ) | 8,916 |  | (12,140 | ) | (18,472 | )
Finance result |  | (257,244 | ) | (287,734 | ) | (233,589 | ) | (271,840 | ) | (261,427 | )
Share of (losses) of equity accounted investees |  | (11,038 | ) | (19,887 | ) | 6,933 |  | (8,280 | ) | (6,582 | )
Profit before income tax from continuing operations |  | 725,842 |  | 695,722 |  | 712,752 |  | 690,250 |  | 589,680 |
Income tax expense |  | (131,436 | ) | (34,408 | ) | (168,209 | ) | (158,809 | ) | (122,597 | )
Profit after income tax from continuing operations |  | 594,406 |  | 661,314 |  | 544,543 |  | 531,441 |  | 467,083 |
Consolidated profit for the year |  | 594,406 |  | 661,314 |  | 544,543 |  | 531,441 |  | 467,083 |
Profit attributable to the Parent |  | 596,642 |  | 662,700 |  | 545,456 |  | 532,145 |  | 470,253 |
(Loss) attributable to non-controlling interests |  | (2,236 | ) | (1,386 | ) | (913 | ) | (704 | ) | (3,170 | )
Basic earnings per ordinary share(1) |  | 0.87 |  | 0.97 |  | 0.80 |  | 0.78 |  | 0.69 |
Average number of shares(1) |  | 687,554,908 |  | 684,197,276 |  | 683,225,815 |  | 683,549,316 |  | 685,344,936 |
Basic earnings per ordinary share from continuing operations(1) |  | 0.87 |  | 0.97 |  | 0.80 |  | 0.78 |  | 0.69 |
Cash dividend per ordinary share (2) |  | 0.40 |  | 0.32 |  | 0.31 |  | 0.65 |  | 0.45 |
Cash dividend per preference share (2) |  | 0.41 |  | 0.33 |  | 0.32 |  | 0.66 |  | 0.46 |

(1) On January 4, 2016, the share split approved on December 3, 2015 by the Company’s Board of Directors became effective. As a result of the share split, the nominal value of the new Class A shares becomes €0.25 per share (previously €0.50 per share), while the nominal value of the new Class B shares becomes €0.05 per share (previously €0.10 per share). In line with the audited financial statements included herein, average weighted number of ordinary shares and basic earnings per ordinary share for 2016 and 2015 have been calculated taking the split into consideration and comparative data for 2014 has been modified accordingly.

(2) Cash dividends for 2018, 2017 and 2016 are not comparable to prior years due to the share split effect explained in note (1) above.

|  | For the Year Ended December 31, |
Consolidated Statement of Comprehensive Income |  | 2018 |  | 2017 |  | 2016 |  | 2015 |  | 2014 |
|  | (in thousands of euros) |
Consolidated profit for the year |  | 594,406 |  | 661,314 |  | 544,543 |  | 531,441 |  | 467,083 |
Other comprehensive expenses |  |  |  |  |  |  |  |  |  |  |
Items for reclassification to profit or loss |  |  |  |  |  |  |  |  |  |  |
Translation differences |  | 268,557 |  | (532,389 | ) | 103,833 |  | 290,635 |  | 303,077 |
Translation differences / Cash Flow Hedge |  | — |  | — |  | (6,809 | ) | — |  | — |
Available for sale financial Assets |  | — |  | 10,145 |  | (5,219 | ) | — |  | — |
Equity accounted investees |  | (9,270 | ) | (27,134 | ) | 10,671 |  | 2,673 |  | 1,287 |
Cash flow hedges — effective part of changes in fair value |  | — |  | — |  | 14,501 |  | 55,305 |  | 34,556 |
Cash flow hedges — amounts taken to profit and loss |  | — |  | — |  | (7,426 | ) | (25,206 | ) | (20,711 | )
Other comprehensive income |  | 102 |  | (14 | ) | (4,810 | ) | 4,575 |  | (406 | )
Tax effect |  | — |  | — |  | (2,462 | ) | (12,093 | ) | (3,865 | )
Other comprehensive income/(loss) for the year, after tax |  | 259,389 |  | (549,392 | ) | 102,279 |  | 315,889 |  | 313,938 |
Total comprehensive income for the year |  | 853,795 |  | 111,922 |  | 646,822 |  | 847,330 |  | 781,021 |
Total comprehensive income attributable to the Parent |  | 856,598 |  | 113,441 |  | 647,667 |  | 848,603 |  | 783,931 |
Total comprehensive income/(expense) attributable to non-controlling interests |  | (2,803 | ) | (1,519 | ) | (845 | ) | (1,273 | ) | (2,910 | )

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B. Capitalization and Indebtedness

Not Applicable.

C. Reasons for the Offer and Use of Proceeds

Not Applicable.

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D. Risk Factors

Risk Relating to Our Structure, Shares and American Depositary Shares

Our substantial level of indebtedness could adversely affect our financial condition, restrict our ability to react to changes to our business, and prevent us from fulfilling our obligations under our debt.

We have a significant amount of indebtedness. As of December 31, 2018, our current and non-current financial liabilities were €6.4 billion, of which a substantial majority (€6.1 billion) was long-term debt.

Our high level of indebtedness could have significant adverse effects on our business, such as:

· making it more difficult for us to satisfy our obligations with respect to our outstanding debt;

· making us more vulnerable to economic downturns and adverse developments in our business;

· impairing our ability to obtain additional financing for working capital, capital expenditures, acquisitions or general corporate purposes;

· reducing the funds available to us for operations and other purposes due to the substantial portion of our cash flow from operations which we use to pay interest on our indebtedness;

· placing a prior ranking claim on the underlying assets of all of the indebtedness outstanding under our purchase money indebtedness, equipment financing and real estate mortgages;

· limiting our ability to fund a change of control offer;

· placing us at a competitive disadvantage compared to our competitors that may have proportionately less debt;

· limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate; and

· restricting us from making strategic acquisitions or exploiting other business opportunities.

We expect to use cash flow from operations to pay our expenses and amounts due under our outstanding indebtedness. Our ability to make these payments depends on our future performance, which will be affected by financial, business, economic and other factors, many of which we cannot control. Our business may not generate sufficient cash flow from operations in the future and our anticipated growth in revenue and cash flow may not be realized, either or both of which could result in our being unable to repay indebtedness or to fund other liquidity needs. If we do not have enough money, we may be required to refinance all or part of our then existing debt, sell assets or borrow more money. We may not be able to accomplish any of these alternatives on terms acceptable to us, or at all. In addition, the terms of existing or future debt agreements may restrict us from adopting any of these alternatives. The failure to generate sufficient cash flow or to achieve any of these alternatives could materially and adversely affect our business, results of operations and financial condition.

Despite our substantial indebtedness, we may still incur significantly more debt. This could exacerbate the risks associated with our substantial leverage.

We may be able to incur substantial additional indebtedness, including additional secured indebtedness, in the future. Our business is capital intensive, and we regularly seek additional capital. Although the indenture governing the 2017 Notes (as defined herein), the New Credit Facilities (as defined herein) and the European Investment Bank Term Loans (as defined herein) contain restrictions on the incurrence of additional debt, these restrictions are subject to a number of qualifications and exceptions and, under certain circumstances, debt incurred in compliance with these restrictions, including secured debt, could be substantial. Adding more debt, including under the New Credit Facilities, to current debt levels could exacerbate the leverage-related risks described above. For more information on our indebtedness, see Item 5 of this Part I, “Operating and Financial Review and Prospects — B. Liquidity and Capital Resources — Sources of Credit.”

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To service our indebtedness and other obligations, we will require a significant amount of cash. Our ability to generate cash depends on many factors beyond our control.

Our ability to make payments on and to refinance our indebtedness and to fund working capital needs and planned capital expenditures will depend on our ability to generate cash in the future. A significant reduction in our operating cash flows resulting from changes in economic conditions, increased competition or other events beyond our control could increase the need for additional or alternative sources of liquidity and could have a material adverse effect on our business, financial condition, results of operations, prospects and our ability to service our debt and other obligations. If we are unable to service our indebtedness, we will be forced to adopt an alternative strategy that may include actions such as reducing capital expenditures, selling assets, restructuring or refinancing our indebtedness or seeking additional equity capital. We cannot assure you that any of these alternative strategies could be effected on satisfactory terms, if at all, or that they would yield sufficient funds to make required payments on our indebtedness.

In addition, our borrowings under the New Credit Facilities are at variable rates of interest and expose us to interest rate risk. If interest rates increase, our debt service obligations on the variable rate indebtedness would increase even though the amount borrowed remained the same, and our net income would decrease.

We cannot assure you that our business will generate sufficient cash flows from operations or that future borrowings will be available to us under the New Credit Facilities or otherwise in an amount sufficient to enable us to pay our indebtedness or to fund our other liquidity needs. We may need to refinance all or a portion of our indebtedness on or before the maturity of such indebtedness. We cannot assure you that we will be able to refinance any of our indebtedness, including the New Credit Facilities, the 2017 Notes and the European Investment Bank Term Loans, on commercially reasonable terms or at all.

Covenants in our debt agreements restrict our business in many ways.

The agreements governing our indebtedness and other financial obligations applicable to us contain various covenants, with customary caveats, that limit our ability and/or our restricted subsidiaries’ ability to, among other things:

· incur or assume liens or additional debt or provide guarantees in respect of obligations of other persons;

· issue redeemable stock and preferred equity;

· pay dividends or make distributions to the shareholders of Grifols, S.A. or redeem or repurchase capital stock;

· prepay, redeem or repurchase debt;

· make loans, investments and capital expenditures;

· enter into agreements that restrict distributions from our restricted subsidiaries;

· sell assets and capital stock of our subsidiaries;

· enter into certain transactions with affiliates; and

· consolidate or merge with or into, or sell substantially all of our assets to, another person.

A breach of any of these covenants could result in a default under our New Credit Facilities, our 2017 Notes and/or the European Investment Bank Term Loans. Upon the occurrence of an event of default under the New Credit Facilities and the European Investment Bank Term Loans, our creditors could elect to declare all amounts outstanding under the New Credit Facilities, the 2017 Notes and the European Investment Bank Term Loans to be immediately due and payable and terminate all commitments to extend further credit. If we were unable to repay those amounts, the lenders under the New Credit Facilities and the European Investment Bank Term Loans could proceed against the collateral granted to them to secure that indebtedness. We have pledged a significant portion of our assets as collateral under the New Credit Facilities and the European Investment Bank Term Loans. If our creditors under the New Credit Facilities, the 2017 Notes or the European Investment Bank Term Loans accelerate the repayment of borrowings, we may not have sufficient assets to repay our indebtedness.

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Our ability to meet our financial obligations depends on our ability to receive dividends and other distributions from our subsidiaries.

Our principal assets are the equity interests that we hold in our operating subsidiaries. As a result, we are dependent on dividends and other distributions from our subsidiaries to generate the funds necessary to meet our financial obligations, including the payment of principal and interest on our outstanding debt. Our subsidiaries may not generate sufficient cash from operations to enable us to make principal and interest payments on our indebtedness. In addition, any payment of dividends, distributions, loans or advances to us by our subsidiaries could be subject to restrictions on dividends or, in the case of foreign subsidiaries, restrictions on repatriation of earnings under applicable local law and monetary transfer restrictions in the jurisdictions in which our subsidiaries operate. In addition, payments to us by our subsidiaries will be contingent upon our subsidiaries’ earnings. Our subsidiaries are permitted under the terms of our indebtedness to incur additional indebtedness that may restrict payments from those subsidiaries to us. We cannot assure you that agreements governing current and future indebtedness of our subsidiaries will permit those subsidiaries to provide us with sufficient cash to fund payments on our indebtedness when due.

Our subsidiaries are legally distinct from us and, except for existing and future subsidiaries that guarantee certain indebtedness, have no obligation, contingent or otherwise, to pay amounts due on our debt or to make funds available to us for such payment.

We are a foreign private issuer under the rules and regulations of the Securities and Exchange Commission and, thus, are exempt from a number of rules under the Securities Exchange Act of 1934 and are permitted to file less information with the Securities and Exchange Commission than a company incorporated in the United States.

As a foreign private issuer under the Securities Exchange Act of 1934, as amended, or the Exchange Act, we are exempt from certain rules under the Exchange Act, including the proxy rules under Section 14 of the Exchange Act, which impose certain disclosure and procedural requirements for proxy solicitations. Moreover, we are not required to file periodic reports and financial statements with the Securities and Exchange Commission, or the SEC, as frequently or as promptly as U.S. companies with securities registered under the Exchange Act; we are not required to file financial statements prepared in accordance with United States generally accepted accounting principles; and we are not required to comply with SEC Regulation FD, which imposes certain restrictions on the selective disclosure of material non-public information. In addition, our officers, directors and principal shareholders are not subject to the reporting or short-swing profit recovery provisions of Section 16 of the Exchange Act or the rules under the Exchange Act with respect to their purchases and sales of our Class A shares or Class B shares. Accordingly, you may receive less information about us than you would receive about a company incorporated in the United States and may be afforded less protection under the U.S. federal securities laws than you would be afforded with respect to a company incorporated in the United States. If we lose our status as a foreign private issuer at some future time, we will no longer be exempt from such rules and, among other things, will be required to file periodic reports and financial statements as if we were a company incorporated in the United States. The costs incurred in fulfilling these additional regulatory requirements could be substantial.

Additionally, pursuant to The NASDAQ Stock Market LLC, or NASDAQ, “Listing Rules,” as a foreign private issuer, we may elect to follow our home country practice in lieu of the corporate governance requirements of the NASDAQ Listing Rule 5600 Series, with the exception of those rules that are required to be followed pursuant to the provisions of NASDAQ Listing Rule 5615(a)(3). We have elected to follow Spanish practices in lieu of the requirements of the NASDAQ Listing Rule 5600 Series to the extent permitted under NASDAQ Listing Rule 5615(a)(3). See Item 16.G. of Part II, “Corporate Governance.”

If we discover material weaknesses or significant deficiencies in our internal control over financial reporting, it may adversely affect our ability to provide timely and reliable financial information and satisfy our reporting obligations under U.S. federal securities laws, which also could affect the market price of our American Depositary Shares or our ability to remain listed on NASDAQ.

Effective internal and disclosure controls are necessary for us to provide reliable financial reports and effectively prevent fraud and to operate successfully as a public company. If we cannot provide reliable financial reports or prevent fraud, our reputation and operating results would be harmed. A “significant deficiency” is a deficiency, or combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit attention of those responsible for oversight of our financial reporting. In addition, a “material weakness” is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company's annual or interim financial statements will not be prevented or detected on a timely basis.

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To the extent that any material weakness or significant deficiency exists in our or our consolidated subsidiaries’ internal control over financial reporting, such material weakness or significant deficiency may adversely affect our ability to provide timely and reliable financial information necessary for the conduct of our business and satisfaction of our reporting obligations under U.S. federal securities laws, which could affect our ability to remain listed on NASDAQ. Ineffective internal and disclosure controls could cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our American Depositary Shares, or ADSs, or the rating of our debt.

The Grifols family may exercise significant influence over the conduct of our business.

The Grifols family and Scranton Enterprises B.V. own, directly and indirectly, 36.4% of our Class A shares. The Class A shares exercise 100% of the voting control of our Company. As a result, the Grifols family and Scranton Enterprises B.V. may exercise significant influence over matters requiring shareholders’ approval, including, among other things, the election of our board of directors, or the Board, dividend policy and certain fundamental corporate action, such as the issuance of bonds, a merger or a dissolution. Conflicts may arise between the interests of the principal shareholders and those of the other shareholders, and the principal shareholders may choose to resolve the conflict in a way that does not coincide with the interests of the other shareholders.

The market price of our Class B ADSs on NASDAQ may be volatile.

The market price of our Class B ADSs may be volatile as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, the following:

· market expectations for our financial performance;

· actual or anticipated fluctuations in our results of operations and financial condition;

· changes in the estimates of our results of operations by securities analysts;

· potential or actual sales of blocks of our Class B ADSs in the market by any shareholder or short selling of our Class B ADSs. Any such transaction could occur at any time or from time to time, with or without notice to us;

· the entrance of new competitors or new products in the markets in which we operate;

· volatility in the market as a whole; and

· the risk factors mentioned in this section.

The market price of our Class B ADSs may be adversely affected by any of the preceding or other factors regardless of operations and financial condition.

Fluctuations in the exchange rate between the U.S. dollar and the euro may increase the risk of holding our ADSs or shares.

The Spanish securities market for equity securities consists of four stock exchanges located in Madrid, Barcelona, Bilbao and Valencia (collectively, the “Spanish Stock Exchanges”). The majority of the transactions conducted on the Spanish Stock Exchanges are done through the Spanish Automated Quotation System (Sistema de Inteconexión Bursátil Español, or SIBE).

Our Class A shares and Class B shares are listed on the Spanish Stock Exchanges and quoted on SIBE in euros. In addition, our Class B shares are traded in the United States on the NASDAQ Global Select Market in the form of ADSs, evidenced by American Depositary Receipts, or ADRs, in U.S. dollars. Fluctuations in the exchange rate between the U.S. dollar and the euro may result in temporary differences between the value of our ADSs and the value of our shares, which may result in heavy trading by investors seeking to exploit such differences. This may increase the volatility of, and have an adverse effect on, the price of our shares or ADSs.

In addition, as a result of fluctuations in the exchange rate between the U.S. dollar and the euro, the U.S. dollar equivalent of the proceeds that a holder of our ADSs would receive upon the sale in Spain of any shares withdrawn from the ADR depositary and the U.S. dollar equivalent of any cash dividends paid in euros on our shares represented by the ADSs could also decline.

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The impact on us of the vote by the UK to leave the EU cannot be predicted.

On June 23, 2016, the United Kingdom voted to leave the European Union in an advisory referendum, which is generally referred to as Brexit. On March 29, 2017, the United Kingdom delivered notice under Article 50 of the Lisbon Treaty of its intent to leave the European Union, beginning a two year negotiation period for the United Kingdom and the 27 remaining members of the European Union to reach agreement on the terms of the exit. The ultimate impact of the “leave” vote will depend on terms that are negotiated in relation to the United Kingdom’s future relationship with the European Union.

Brexit may lead to legal uncertainty and potentially divergent laws and regulations between the United Kingdom and the European Union, as the United Kingdom determines which European Union laws to replicate or replace. We cannot predict whether or not the United Kingdom will significantly alter its current laws and regulations in respect of the pharmaceutical industry and, if so, what impact any such alteration would have on us or our business. Moreover, we cannot predict the impact that Brexit will have on (i) the marketing of pharmaceutical products or (ii) the process to obtain regulatory approval in the United Kingdom for product candidates.

Brexit may also result in a reduction of funding to the EMA if the United Kingdom no longer makes financial contributions to European institutions, such as the EMA. If United Kingdom funding is so reduced, it could create delays in the EMA issuing regulatory approvals for our product candidates and, accordingly, have a material adverse effect on our business, financial position, results of operations and future growth prospects.

In addition, following the Brexit vote, the European Union has decided to move the headquarters of the EMA from the United Kingdom to the Netherlands by March 2019. It is expected that a significant percentage of the current employees of the EMA will decide not to make the move to the Netherlands. This raises the possibility that new drug approvals in the European Union could be delayed as a result.

The phasing out and ultimate replacement of LIBOR with an alternative reference rate and changes in the manner of calculating other reference rates may adversely impact the value of loans and other financial instruments we hold that are linked to LIBOR or other reference rates in ways that are difficult to predict and could adversely impact our financial condition and results of operations.

In July 2017, the United Kingdom’s Financial Conduct Authority, which regulates LIBOR, announced that it intends to phase out Libor by the end of 2021, and for LIBOR to be replaced with an alternative reference rate that will be calculated in a different manner. Similar changes have occurred or may occur with respect to other reference rates. It is not currently possible to determine whether, or to what extent, any such changes would impact the value of any loans, derivatives and other financial obligations or extensions of credit we hold or that are due to us that are linked to LIBOR or other reference rates or whether, or to what extent, such changes would impact our business, financial condition, results of operations or future prospects.

Subscription (or preemptive) rights may be unavailable to U.S. holders of our shares or ADSs.

In the case of a future increase of our registered share capital, existing shareholders will generally be entitled to subscription (or preemptive) rights pursuant to Spanish law, unless waived by a resolution of the shareholders or, if such power has been delegated to the Board pursuant to a shareholders’ resolution, by a resolution of the Board and except in certain situations, such as capital increases made for an in-kind contribution, in which subscription (or preemptive) rights are not applicable by law. Holders of the Class B shares will generally not have a right to vote on any resolution on a capital increase or on the waiver of subscription (or preemptive) rights, unless such resolution does not treat the Class B shares in the same way as the Class A shares, except in the limited circumstances set out in the Articles of Association of Grifols, S.A. as amended, or the Articles of Association.

Even if preemptive rights are granted, holders of our ADSs or U.S. resident shareholders may not be able to exercise subscription (or preemptive) rights, in which case holders of our ADSs could be substantially diluted, unless a registration statement under the Securities Act of 1933, as amended, or the Securities Act, is effective with respect to such rights and the shares for which they give such right or an exemption from the registration requirements of the Securities Act is available.

We intend to evaluate at the time of any rights offering the costs and potential liabilities associated with any such registration requirements, as well as the benefits of enabling the exercise of subscription (or preemptive) rights for the shares. In doing so, we will also evaluate any other factors that we may consider appropriate at the time.

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There can be no assurance that we will decide to comply with such registration requirements. If no such registration requirements are satisfied, the depositary will sell the subscription (or preemptive) rights relating to the ADSs on deposit and will distribute the proceeds of such sale, if any, to the holders of the ADSs. If the depositary is unable to sell rights that are not exercised or not distributed or if the sale is not lawful or reasonably practicable, it will allow the rights to lapse, in which case no value will be given for these rights.

ADS holders may be subject to limitations on the transfer of their ADSs.

ADSs are transferable on the books of the depositary. However, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when the books of the depositary are closed or if such action is deemed necessary or advisable by the depositary or by us because of any requirement of law or of any government or governmental body or commission or under any provision of the deposit agreement. Moreover, the surrender of ADSs and withdrawal of our shares may be suspended subject to the payment of fees, taxes and similar charges or if we direct the depositary at any time to cease new issuances and withdrawals of our shares during periods specified by us in connection with shareholders’ meetings, the payment of dividends or as otherwise reasonably necessary for compliance with any applicable laws or government regulations.

Your ability to enforce civil liabilities under U.S. securities laws may be limited.

We are a company organized under the laws of Spain, and many of our subsidiaries are also incorporated outside of the United States. A substantial portion of our assets and the assets of our subsidiaries are located outside of the United States. In addition, nearly all of our directors and officers and certain of our subsidiaries’ officers and directors are nationals or residents of countries other than the United States, and all or a substantial portion of such persons’ assets are located outside the United States. As a result, it may be difficult for investors to effect service of process within the United States upon us, certain of our subsidiaries or their directors or officers with respect to matters arising under the Securities Act or to enforce against them judgments of courts of the United States predicated upon civil liability under the Securities Act. It may also be difficult to recover fully in the United States on any judgment rendered against such persons or against us or certain of our subsidiaries.

In addition, there is doubt as to the enforceability in Spain of original actions, or of actions for enforcement of judgments of U.S. courts of liabilities, predicated solely upon the securities laws of the United States. If a judgment was obtained outside Spain and efforts were made to enforce the judgment in Spain, there is some doubt that Spanish courts would agree to recognize and enforce a foreign judgment. Accordingly, even if you obtain a favorable judgment in a U.S. court, you may be required to re-litigate your claim in Spain.

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Risks Relating to Our Business

Our manufacturing processes are complex and involve biological intermediates that may be susceptible to contamination and variations in yield.

Plasma is a raw material that is susceptible to damage and contamination and may contain human pathogens, any of which would render the plasma unsuitable for further manufacturing. For instance, contamination or improper storage of plasma by us or third-party suppliers may require us to destroy some of our raw material. If unsuitable plasma is not identified and discarded prior to its release to our manufacturing processes, it may be necessary to discard intermediate or finished product made from that plasma or to recall any finished product released to the market, resulting in a charge to cost of goods sold.

The manufacture of our plasma products is an extremely complex process of fractionation (separating the plasma into component proteins), purification, filling and finishing. Our products can become non-releasable or otherwise fail to meet our specifications through a failure of one or more of our product testing, manufacturing, process controls and quality assurance processes. We may detect instances in which an unreleased product was produced without adherence to our manufacturing procedures or plasma used in our production process was not collected or stored in a compliant manner consistent with cGMP (Current Good Marketing Practice) regulations enforced by the US Food and Drug Administration, or the FDA or other regulations, which would likely result in our determination that the impacted products should not be released and therefore should be destroyed.

Once we have manufactured our plasma-derived products, they must be handled carefully and kept at appropriate temperatures. Our failure, or the failure of third parties that supply, ship or distribute our products, to properly care for our plasma-derived products may require that such products be destroyed.

While we expect to write off small amounts of work in process inventories in the ordinary course of business due to the complex nature of plasma, our processes and our products, unanticipated events may lead to write-offs and other costs materially in excess of our expectations. Such write-offs and other costs could cause material fluctuations in our profitability. Furthermore, contamination of our products could cause investors, consumers or other third parties with whom we conduct business to lose confidence in the reliability of our manufacturing procedures, which could adversely affect our sales and profits. In addition, faulty or contaminated products that are unknowingly distributed could result in patient harm, threaten the reputation of our products and expose us to product liability damages and claims.

Due to the nature of plasma, there will be variations in the biologic properties of the plasma we collect or purchase for fractionation that may result in fluctuations in the obtainable yield of desired fractions, even if cGMP regulations are followed. Lower yields may limit production of our plasma-derived products due to capacity constraints. If such batches of plasma with lower yields impact production for extended periods, it may reduce the total capacity of product that we could market and increase our cost of goods sold, thereby reducing our profitability.

Our manufacture of intermediate immunoassay antigens and antibodies to screen human donated blood and blood products is also a complex biologic process, subject to substantial production risks. These processes typically involve an upstream or fermentation process and a downstream or purification process. Since in the upstream process we deal with living cells, we may face a contamination by undesired cells which would eventually translate in a low yield. Yields in general can also be greatly affected by the different nutrients compositions added to the reactors in this fermentation step. Likewise during the purification step, we can face low yields due to poor resins composition, equipment failure or procedural mistakes.

Once our products are approved and marketed, we must continually monitor them for signs that their use may result in serious and unexpected side effects, which could jeopardize our reputation and our ability to continue marketing our products. We may also be required to conduct post-approval clinical trials as a condition to licensing a product.

As for all pharmaceutical products, the use of our products sometimes produces undesirable side effects or adverse reactions or events (collectively, “adverse events”). For the most part these adverse events are known, expected to occur at some frequency and are described in the products’ labeling. Known adverse events of a number of our products include allergic or anaphylactic reactions including shock and the transmission of infective agents. Further, the use of certain products sometimes produces additional adverse events, which are detailed below.

· The use of albumin sometimes produces the following adverse events: hypervolemia, circulatory overload, pulmonary edema, hyperhydration and allergic manifestations including urticaria, chills, fever and changes in respiration, pulse and blood pressure.

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· The use of blood clotting Factor IX sometimes produces the following adverse events: the induction of neutralizing antibodies; thromboembolism, including myocardial infarction; disseminated intravascular coagulation; venous thrombosis and pulmonary embolism; and in the case of treatment for immune tolerance induction, nephrotic syndrome.

· The use of the antihemophilic blood clotting factor, or Factor VIII, sometimes produces the following adverse events: the induction of neutralizing antibodies, thromboembolic events and hemolytic anemia or hemolysis.

· The use of intravenous immunoglobulin, or IVIG, sometimes produces the following adverse events: nausea, vomiting, asthenia, pyrexia, rigors, injection site reaction, allergic or anaphylactic reaction, aseptic meningitis, arthralgia, back pain, dizziness, headache, rash, pruritus, urticaria, hemolysis or hemolytic anemia, hyperproteinemia, increased serum viscosity and hyponatremia, thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses, transfusion-related acute lung injury and renal dysfunction and acute renal failure.

· The use of anti-hepatitis B IVIG sometimes produces the following adverse events: thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses, aseptic meningitis, hemolytic anemia or hemolysis and acute renal failure.

· The use of Koate®-DVI, which we license exclusively in the United States to Kedrion S.p.A, a corporation organized under the laws of Italy, sometimes produces the following adverse events: allergic reactions, tingling in the arm, ear and face, blurred vision, headache, nausea, stomach ache and a jittery feeling.

· The use of Prolastin®, Prolastin®-C, alpha-1 proteinase inhibitor, or A1PI, sometimes produces the following adverse events: dyspnea, tachycardia, rash, chest pain, chills, influenza-like symptoms, hypersensitivity, hypotension and hypertension.

In addition, the use of our products may be associated with serious and unexpected adverse events, or with less serious reactions at a greater than expected frequency. This may be especially true when our products are used in critically ill patient populations. When these unexpected events are reported to us, we must undertake a thorough investigation to determine causality and implications for product safety. These events must also be specifically reported to the applicable regulatory authorities. If our evaluation concludes, or regulatory authorities perceive, that there is an unreasonable risk associated with the product, we would be obligated to withdraw the impacted lot(s) of that product. Furthermore, an unexpected adverse event caused by a new product may be recognized only after extensive use of the product, which could expose us to product liability risks, enforcement action by regulatory authorities and damage to our reputation.

Once we produce a product, we rely on physicians to prescribe and administer it as we have directed and for the indications described on the labeling. It is not, however, unusual for physicians to prescribe our products for unapproved, or off-label, uses or in a manner that is inconsistent with our directions. To the extent such off-label uses and departures from our administration directions become pervasive and produce results such as reduced efficacy or other adverse effects, the reputation of our products in the marketplace may suffer.

Our ability to continue manufacturing and distributing our products depends on our continued adherence to cGMP regulations at our facilities.

The manufacturing processes for our products are governed by detailed written procedures and governmental regulations that set forth cGMP requirements for blood, blood products and other products. Our quality operations unit monitors compliance with these procedures and regulations, and the conformance of materials, manufacturing intermediates and final products to their specifications. Failure to adhere to established procedures or regulations, or to meet a specification, could require that a product or material be rejected and destroyed.

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Our adherence to cGMP regulations and the effectiveness of our quality systems are periodically assessed through inspections of our facilities by the U.S. Food and Drug Administration, or the FDA, and analogous regulatory authorities of other countries. If deficiencies are noted during an inspection, we must take action to correct those deficiencies and to demonstrate to the regulatory authorities that our corrections have been effective. If serious deficiencies are noted or if we are unable to prevent recurrences, we may have to recall product or suspend operations until appropriate measures can be implemented. We are also required to report certain deviations from procedures to the FDA and even if we determine that the deviations were not material, the FDA could require us to take similar measures. Since cGMP reflects ever-evolving standards, we regularly need to update our manufacturing processes and procedures to comply with cGMP. These changes may cause us to incur costs without improving our profitability or the safety of our products. For example, more sensitive testing assays (if and when they become available) may be required or existing procedures or processes may require revalidation, all of which may be costly and time consuming and could delay or prevent the manufacturing of a product or launch of a new product.

Changes in manufacturing processes, including a change in the location where the product is manufactured or a change of a third-party manufacturer, may require prior FDA review and approval or revalidation of the manufacturing processes and procedures in accordance with cGMP regulations. There may be comparable foreign requirements.

Grifols received approval from the FDA to relocate existing immunodiagnostic manufacturing operations to a new consolidated manufacturing facility in Emeryville, California, or our Emeryville facility. The first approval from the FDA enabled the implementation of cGMP in fermentation, purification and bulk fill operations in the facility and the production of one recombinant HCV antigen. Additional submissions to the FDA are planned to relocate the production of other licensed recombinant protein products. The transition is targeted for completion in mid-2019, pending FDA approvals for the licensed antigens. Once the transition is complete, Grifols will have transferred 21 products to the new Emeryville facility.

To validate our manufacturing processes and procedures following completion of our upgraded facilities, we must demonstrate that the processes and procedures at the upgraded facilities are comparable to those currently in place at our other facilities. To provide such a comparative analysis, both the existing processes and the processes that we expect to be implemented at our upgraded facilities must comply with the regulatory standards prevailing at the time that our expected upgrade is completed. In addition, regulatory requirements, including cGMP regulations, continually evolve. Failure to adjust our operations to conform to new standards as established and interpreted by applicable regulatory authorities would create a compliance risk that could impair our ability to sustain normal operations.

Regulatory authorities, including the FDA and the European Medicines Agency, or the EMA, routinely inspect our facilities to assess ongoing compliance with cGMP. If the FDA, the EMA or other regulatory authorities find our facilities to be out of compliance, our ongoing operations or plans to expand would be adversely affected.

A significant disruption in our supply of plasma could have a material adverse effect on our business and our growth plans.

The majority of our revenue depends on our access to U.S. source plasma (plasma obtained through plasmapheresis), the principal raw material for our plasma derivative products. Our ability to increase revenue depends substantially on increased access to plasma. If we are unable to obtain sufficient quantities of source plasma, we may be unable to find an alternative cost-effective source of plasma and we would be limited in our ability to maintain current manufacturing levels of plasma derivative products. As a result, we could experience a substantial decrease in net revenues or profit margins, a loss of customers, a negative effect on our reputation as a reliable supplier of plasma derivative products or a substantial delay in our production growth plans.

Our current business plan envisages an increase in the production of plasma derivative products, which depends on our ability to increase plasma collections or improve product yield. The ability to increase plasma collections may be limited, our supply of plasma could be disrupted or the cost of plasma could increase substantially, as a result of numerous factors, including:

· A reduction in the donor pool. Regulators in most of the largest markets for plasma derivative products, including the United States, restrict the use of plasma collected from specific countries and regions in the manufacture of plasma derivative products. For example, the appearance of the variant Creutzfeldt Jakob, or mad cow disease, resulted in the suspension of the use of plasma collected from U.K. residents and concern over the safety of blood products, which has led to increased domestic and foreign regulatory control over the collection and testing of plasma and the disqualification of certain segments of the population from the donor pool, significantly reducing the potential donor pool. The appearance of new viral strains could further reduce the potential donor pool. Also, improvements in socioeconomic conditions in the areas in which our and our suppliers’ plasma collection centers are located could reduce the attractiveness of financial incentives for potential donors, resulting in increased fees paid to donors or a reduction in the number of donors.

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· Regulatory requirements. See “—Disruption of the operations of our plasma collection centers would cause us to become supply constrained and our financial performance would suffer.”

· Plasma supply sources. In recent years, there has been vertical integration in the industry as plasma derivatives manufacturers have been acquiring plasma collection centers. Any significant disruption in the supply of plasma or an increased demand for plasma may require us to obtain plasma from alternative sources, which may not be available on a timely basis.

Disruption of the operations of our plasma collection centers would cause us to become supply constrained and our financial performance would suffer.

In order for plasma to be used in the manufacturing of our products, the individual centers at which the plasma is collected must be licensed and approved by the regulatory authorities, such as the FDA and the EMA, of those countries in which we sell our products. When a new plasma collection center is opened, it must be inspected on an ongoing basis after its approval by the FDA and the EMA for compliance with cGMP and other regulatory requirements, and these regulatory requirements are subject to change. For example, an FDA final rule, effective May 23, 2016, addressed the collection of blood components, such as plasma, intended for transfusion or further manufacturing use, including requirements with respect to donor education, donor history and donor testing. While we believe that our centers have timely adopted the regulations, which generally reflected our existing approaches, the compliance efforts necessary for evolving requirements, such as these, may increase our costs. An unsatisfactory inspection could prevent a new center from being approved for operation or risk the suspension or revocation of an existing approval.

In order for a plasma collection center to maintain its governmental approval to operate, its operations must continue to conform to cGMP and other regulatory requirements. In the event that we determine a plasma collection center did not comply with cGMP in collecting plasma, we may be unable to use and may ultimately destroy plasma collected from that center, which would be recorded as a charge to cost of goods. Additionally, if noncompliance in the plasma collection process is identified after the impacted plasma has been pooled with compliant plasma from other sources, entire plasma pools, in-process intermediate materials and final products could be impacted. Consequently, we could experience significant inventory impairment provisions and write-offs.

We plan to continue to obtain our supplies of plasma for use in our manufacturing processes through collections at our plasma collection centers and through selective acquisitions or remodeling and relocations of existing centers. This strategy is dependent upon our ability to successfully integrate new centers, to obtain FDA and other necessary approvals for any centers not yet approved by the FDA, to maintain a cGMP compliant environment in all centers and to attract donors to our centers.

Our ability to increase and improve the efficiency of production at our plasma collection centers may be affected by: (i) changes in the economic environment and population in selected regions where we operate plasma collection centers; (ii) the entry of competitive centers into regions where we operate; (iii) our misjudging the demographic potential of individual regions where we expect to increase production and attract new donors; (iv) unexpected facility related challenges; or (v) unexpected management challenges at select plasma collection centers.

A significant portion of our net revenue has historically been derived from sales of our immunoglobulin products and we expect that they will continue to comprise a significant portion of our sales. Any adverse market event with respect to these products could have a material adverse effect on us.

We have historically derived a significant portion of our net revenues from our immunoglobulin products, including our IVIG products. In 2018, our IVIG products accounted for approximately 42% of our net revenues. If any of these IVIG products were to lose significant sales or were substantially or completely displaced in the market, we would lose a significant and material source of our net revenue. Similarly, if either Flebogamma® or Gamunex®-C/Gamunex® were to become the subject of litigation or an adverse governmental ruling requiring us to cease sales of it, our business could be adversely affected. Although we do not currently anticipate any significant decrease in the sales of any of these products, a significant decrease could result from plasma procurement and manufacturing issues resulting in lower product availability for sales and changing market conditions.

We face significant competition.

We face significant competition. Each of Takeda, CSL Behring, Kedrion Biopharma, Octapharma Plasma and Bio Products Laboratory Ltd. (BPL) now has a 10% liquid IVIG product in the United States. Both Octapharma and Bio Products Laboratory have launched 5% liquid IVIG products. As competition has increased, some of our competitors have discounted the price of IVIG products as many customers have become increasingly price sensitive with respect to IVIG products. If customers demand lower priced products, we may lose sales or be forced to lower our prices.

In 2015, the European Commission granted marketing authorization for CSL’s Respreeza® in all European Union member states. This product is a more concentrated intravenous formulation than the one we offer in Europe. Another competitor offers an

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inhaled formula and submitted a Marketing Authorization Application with the EMA at the beginning of 2016 that was withdrawn in June 2017. The same competitor proposed a Phase III protocol to the FDA in July 2017. Our current and future competitors may increase their sales, lower their prices, change their distribution model or improve their products, causing harm to our product sales and market share. Also, if the attrition rate of our A1PI patient base accelerates faster than we have forecasted, we would have fewer patients and lower sales volume.

Other new treatments, such as small molecules, monoclonal or recombinant products, may also be developed for indications for which our products are now used. Recombinant Factor VIII and Factor IX products, which are currently available and widely used in the United States and Europe, compete with our plasma-derived product in the treatment of hemophilia A and B and are perceived by many to have lower risks of disease transmission. Additional recombinant products and new small molecules, some with extended half-lives, could compete with our products and reduce the demand for our products. At the end of 2016, Kamada announced the BLA (Biologics License Application) submission of its rabies product to compete with our rabies hyperimmune product in the United States, and received FDA approval in August 2017. In February 2009, GTC Biotherapeutics obtained FDA approval of a competitive antithrombin III, or ATIII, a product derived from the milk of transgenic goats for the treatment of hereditary antithrombin deficiency. This product now directly competes with our product, Thrombate® III, which had previously been the only FDA-approved ATIII product. In addition, alternatives exist for albumin in its application as a plasma volume expander. If an increased use of alternative products for Factor VIII, Factor IX or albumin makes it uneconomical to produce our plasma-derived products, or if further technological advances improve these products or create other competitive alternatives to our plasma derivative products, our financial condition and results of operations could be materially adversely affected.

We do not currently sell any recombinant products. We have recombinant versions of A1PI and plasmin in our pipeline, but we cannot be certain that any of these products will ever be approved or commercialized. As a result, our product offerings may remain plasma-derived, even if our competitors offer competing recombinant products. In October 2018, the FDA approved Genetech, Inc’s emicizumab-kxwh injection treatment, Hemlibra, a non-plasma product to control bleeding in patients with hemophilia A. The use of Hemlibra presents a potentially significant competitive risk for the use of plasma derived Factor VIII.

The introduction of products approved for alternative routes of administration, including the subcutaneous route of administration, may also adversely affect sales of our products. For example, CSL Behring and Takeda introduced a preparation of human immunoglobulin at a 20% concentration for the treatment of people who need replacement of antibodies and Takeda has an immune globulin with a recombinant human hyaluronidase indicated for the treatment of Primary Immunodeficiency (PI) in adults. According to the MRB, the global market for subcutaneous products is relatively small. Our 10% Gamunex® has the FDA approval to be administered intravenously or subcutaneously and we are working on a 20% concentration product to be administered in both ways.

We face competition from companies with greater financial resources.

We operate in highly competitive markets. Our principal competitors include Takeda, CSL Behring and Octapharma. Some of our competitors have significantly greater financial resources than us. As a result, they may be able to devote more funds to research and development and new production technologies, as well as to the promotion of their products and business. These competitors may also be able to sustain for longer periods a deliberate substantial reduction in the price of their products or services. The development by a competitor of a similar or superior product or increased pricing competition may result in a reduction in our net revenues or a decrease in our profit margins.

Technological changes in the production of plasma derivative and diagnostic products could render our production process uneconomical.

Technological advances have accelerated changes in recent years. Future technological developments could render our production processes uneconomical and may require us to invest substantial amounts of capital to upgrade our facilities. Such investments could have a material adverse effect on our financial condition and results of operations. In addition, we may not be able to fund such investments from existing funds or raise sufficient capital to make such investments.

The discovery of new pathogens could slow our growth and adversely affect profit margins.

The possible appearance of new pathogens could trigger the need for changes in our existing inactivation and production methods, including the administration of new detection tests. Such a development could result in delays in production until the new methods are in place, as well as increased costs that may not be readily passed on to our customers.

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Product liability claims or product recalls involving our products or products we distribute could have a material adverse effect on our business.

Our business exposes us to the risk of product liability claims. We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and an even greater risk when we commercially sell any products. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

· decreased demand for our products and any product candidates that we may develop;

· injury to our reputation;

· withdrawal of clinical trial participants;

· costs to defend the related litigation;

· substantial monetary awards to trial participants or patients;

· loss of revenue; and

· the inability to commercialize any products that we may develop.

Like many plasma fractionators, we have been, and may in the future be, involved in product liability or related claims relating to our products, including claims alleging the transmission of disease through the use of such products. Plasma is a biological matter that is capable of transmitting viruses and pathogens, whether known or unknown. Therefore, our plasma and plasma derivative products, if donors are not properly screened or if the plasma is not properly collected, tested, inactivated, processed, stored and transported, could cause serious disease and possibly death to the patient. See also “—Our ability to continue to produce safe and effective products depends on a plasma supply free of transmittable diseases.” Any transmission of disease through the use of one of our products or third-party products sold by us could result in claims by persons allegedly infected by such products.

Our potential product liability also extends to our Diagnostic and Hospital division products. In addition, we sell and distribute third-party products, and the laws of the jurisdictions where we sell or distribute such products could also expose us to product liability claims for those products. Furthermore, the presence of a defect in a product could require us to carry out a recall of such product.

A product liability claim or a product recall could result in substantial financial losses, negative reputational repercussions and an inability to retain customers. Although we have a program of insurance policies designed to protect us and our subsidiaries from product liability claims, and we self-insure a portion of this risk, claims made against our insurance policies could exceed our limits of coverage. We intend to expand our insurance coverage as our sales grow. However, as product liability insurance is expensive and can be difficult to obtain, a product liability claim could decrease our access to product liability insurance on acceptable terms. In turn, we may not be able to maintain insurance coverage at a reasonable cost and may not be able to obtain insurance coverage that will be adequate to satisfy any liability that may arise.

Our ability to continue to produce safe and effective plasma derivative products depends on a plasma supply free of transmittable diseases.

Despite overlapping safeguards, including the screening of donors and other steps to remove or inactivate viruses and other infectious disease-causing agents, the risk of transmissible disease through plasma-derived products cannot be entirely eliminated. If a new infectious disease was to emerge in the human population, the regulatory and public health authorities could impose precautions to limit the transmission of the disease that would impair our ability to procure plasma, manufacture our products or both. Such precautionary measures could be taken before there is conclusive medical or scientific evidence that a disease poses a risk for plasma-derived products.

In recent years, new testing and viral inactivation methods have been developed that more effectively detect and inactivate infectious viruses in collected plasma. There can be no assurance, however, that such new testing and inactivation methods will adequately screen for, and inactivate, infectious agents in the plasma used in the production of our products.

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Plasma and plasma derivative products are fragile, and improper handling of our plasma or plasma derivative products could adversely affect results of operations.

Plasma is a raw material that is susceptible to damage. Almost immediately after its collection from a donor, plasma is stored and transported at temperatures that are at least -20 degrees Celsius (-4 degrees Fahrenheit). Once we manufacture plasma derivative products, they must be handled carefully and kept at appropriate temperatures. Our failure, or the failure of third parties that supply, ship or distribute our plasma and plasma derivative products, to properly care for our plasma or plasma derivative products may require us to destroy some raw materials or products. If the volume of plasma or plasma derivative products damaged by such failures were to be significant, the loss of that plasma or those plasma derivative products could have a material adverse effect on our financial condition and results of operations.

Our future success depends on our ability to retain members of our senior management and to attract, retain and motivate qualified personnel.

We are highly dependent on the principal members of our executive and scientific teams. The loss of the services of any of these persons might impede the achievement of our research, development, operational and commercialization objectives. In particular, we believe the loss of any member of our senior management team would significantly and negatively impact our business. For details regarding the members of senior management, see Item 6 of this Part I, “Directors, Senior Management and Employees — A. Directors and Senior Management — Senior Management.” We do not maintain “key person” insurance on any of our senior management.

Recruiting and retaining qualified operations, finance and accounting, scientific, clinical and sales and marketing personnel will be critical to our success. We may not be able to attract and retain these personnel on acceptable terms, given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. If we are unable to attract, retain and motivate qualified and experienced personnel, we could lose customers and suffer reduced profitability. Even if we are successful in attracting and retaining such personnel, competition for such employees may significantly increase our compensation costs and adversely affect our financial condition and results of operations.

cGMP regulations also require that the personnel we employ and hold responsible for product manufacturing, including, for example, the collection, processing, testing, storage or distribution of blood or blood components, be adequate in number, educational background, training (including professional training as necessary) and experience, or a combination thereof, and have capabilities commensurate with their assigned functions, a thorough understanding of the procedures or control operations they perform, the necessary training or experience and adequate information concerning the application of relevant cGMP requirements to their individual responsibilities. Our failure to attract, retain and motivate qualified personnel may result in a regulatory violation, affect product quality, require the recall or market withdrawal of affected product or result in a suspension or termination of our license to market our products, or any combination thereof.

Our business requires substantial capital to operate and grow and to achieve our strategy of realizing increased operating leverage, including the completion of several large capital projects.

We have implemented several large capital projects to expand and improve our facilities and to improve the structure of our plasma collection centers in the United States. These projects may run over budget or be delayed. We cannot be certain that these projects will be completed in a timely manner or that we will maintain our compliance with cGMP regulations, and we may need to spend additional amounts to achieve compliance. Additionally, by the time these multi-year projects are completed, market conditions may differ significantly from our assumptions regarding the number of competitors, customer demand, alternative therapies, reimbursement and public policy, and as a result, capital returns might not be realized.

We also plan to continue to spend substantial sums on research and development, to obtain the approval of the FDA, and other regulatory agencies, for new indications for existing products, to develop new product delivery mechanisms for existing products and to develop innovative product additions. We face a number of obstacles to successfully converting these efforts into profitable products, including, but not limited to, the successful development of an experimental product for use in clinical trials, the design of clinical study protocols acceptable to the FDA and other regulatory agencies, the successful outcome of clinical trials, our ability to scale our manufacturing processes to produce commercial quantities or successfully transition technology, the approval of the FDA and other regulatory agencies of our products and our ability to successfully market an approved product or new indication.

For example, when a new product is approved, the FDA or other regulatory authorities may require post-approval clinical trials, sometimes called Phase IV clinical trials. If the results of such trials are unfavorable, this could result in the loss of the license to market the product, with a resulting loss of sales.

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We are expecting significant capital spending as we are undertaking an investment plan that involves among other investments, cumulative industrial capital investments to expand the manufacturing capacities of the Bioscience division of approximately €400 million from 2019 through 2020 as part of our €1.2 billion 2016-2020 capital expenditure plan. The amount and timing of future capital spending is dependent upon a number of factors, including market conditions, regulatory requirements and the extent and timing of particular projects, among other things. Our ability to grow our business is dependent upon the timely completion of these projects and obtaining the requisite regulatory approvals.

We may not be able to develop some of our international operations successfully.

We currently conduct sales in over 100 countries. The successful operation of such geographically dispersed resources requires considerable management and financial resources. In particular, we must bridge our business culture to the business culture of each country in which we operate. In addition, international operations and the provision of services in foreign markets are subject to additional risks, such as changing market conditions, currency exchange rate fluctuations, trade barriers, exchange controls, regulatory changes, changes to tax regimes, foreign investment limitations, civil disturbances and war. Furthermore, if an area in which we have significant operations or an area into which we are looking to expand suffers an economic recession or currency devaluation, our net revenues and accounts receivable collections in that region will likely decline substantially or we may not be able to successfully expand or operate in that region.

We are susceptible to interest rate variations.

We use issuances of debt and bank borrowings as a source of funding. At December 31, 2018, $5.3 billion and €607 million of our senior interest bearing debt, which represented 81.2% of our senior interest bearing debt, bore interest at variable rates, at a spread over the London Interbank Offered Rate, or LIBOR, for our U.S. dollar denominated debt and at a spread over the Euro Interbank Offered Rate, or EURIBOR, for our euro denominated debt. Any increase in interest rates payable by us, which could be adversely affected by, among other things, our inability to meet certain financial ratios, would increase our interest expense and reduce our cash flow, which could materially adversely affect our financial condition and results of operations. See Item 11 of this Part I, “Quantitative and Qualitative Disclosures About Market Risk — Interest Rate Risk.”

Our results of operations and financial condition may be affected by adverse changes in foreign currency exchange rates, especially a significant shift in the value of the euro as compared to the U.S. dollar.

A significant portion of our business is conducted in currencies other than our reporting currency, the euro. In 2018, €3.4 billion, or 75%, of our net revenue of €4.5 billion was denominated in U.S. dollars. We are also exposed to currency fluctuations with respect to other currencies, such as the British pound, the Brazilian real, the Canadian dollar and the Argentine, Mexican and Chilean pesos. Currency fluctuations among the euro, the U.S. dollar and the other currencies in which we do business result in foreign currency translation gains or losses that could be significant.

We are also exposed to risk based on the payment of U.S. dollar denominated indebtedness. At December 31, 2018, we had approximately $5.3 billion of U.S. dollar denominated senior debt. See Item 11 of this Part I, “Quantitative and Qualitative Disclosures About Market Risk — Currency Risk.”

If the San Diego, Clayton, Emeryville, Los Angeles or Parets facilities were to suffer a crippling accident, or if a force majeure event materially affected our ability to operate and produce saleable products, a substantial part of our manufacturing capacity could be shut down for an extended period.

A substantial portion of our revenue is derived from plasma fractionation or products manufactured at our San Diego, Clayton, Emeryville, Los Angeles and Parets facilities. In addition, a substantial portion of our plasma supply is stored at facilities in City of Industry, California, as well as at our Clayton, North Carolina and Parets facilities. If any of these facilities were to be impacted by an accident or a force majeure event such as an earthquake, major fire, storm or explosion, major equipment failure or power failure lasting beyond the capabilities of our backup generators, our revenue would be materially adversely affected. In this situation, our manufacturing capacity could be shut down for an extended period and we could experience a loss of raw materials, work-in-process or finished goods inventory. Other force majeure events such as terrorist acts, influenza pandemic or similar events could also impede our ability to operate our business. In addition, in the event of the reconstruction of our Clayton, Los Angeles or Parets facilities or our plasma storage facilities, gaining the regulatory approval for such new facilities and the replenishment of raw material plasma could be time consuming. During this period, we would be unable to manufacture all of our products at other plants due to the need for FDA and foreign regulatory authority inspection and certification of such facilities and processes.

Our property damage and business interruption insurance may be insufficient to mitigate the losses from any such accident or force majeure event. We may also be unable to recover the value of the lost plasma or work-in-process inventories, as well as the sales opportunities from the products we would be unable to produce.

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If we experience equipment difficulties or if the suppliers of our equipment or disposable goods fail to deliver key product components or supplies in a timely manner, our manufacturing ability would be impaired and our product sales could suffer.

We depend on a limited number of companies that supply and maintain our equipment and provide supplies such as chromatography resins, filter media, glass and stoppers used in the manufacture of our products. If our equipment should malfunction, the repair or replacement of the machinery may require substantial time and cost, which could disrupt our production and other operations. Our plasma collection centers rely on disposable goods supplied by third parties and information technology systems hosted by third parties. Our plasma collection centers cannot operate without an uninterrupted supply of these disposable goods and the operation of these systems. Alternative sources for key component parts or disposable goods may not be immediately available. And while we have experienced periodic outages of these systems, a material outage would affect our ability to operate our collection centers. Any new equipment or change in supplied materials may require revalidation by us or review and approval by the FDA or foreign regulatory authorities, including the EMA, which may be time-consuming and require additional capital and other resources. We may not be able to find an adequate alternative supplier in a reasonable time period, or on commercially acceptable terms, if at all. As a result, shipments of affected products may be limited or delayed. Our inability to obtain our key source supplies for the manufacture of products may require us to delay shipments of products, harm customer relationships and force us to curtail operations.

If our shipping or distribution channels were to become inaccessible due to a crippling accident, an act of terrorism, a strike, earthquake, major fire or storm, or any other force majeure event, our supply, production and distribution processes could be disrupted.

Not all shipping or distribution channels are equipped to transport plasma. If any of our shipping or distribution channels becomes inaccessible due to a crippling accident, an act of terrorism, a strike, earthquake, major fire or storm or any other force majeure event, we may experience disruptions in our continued supply of plasma and other raw materials, delays in our production process or a reduction in our ability to distribute our products directly to our customers.

We rely in large part on third parties for the sale, distribution and delivery of our products.

In the United States, we regularly enter into distribution, supply and fulfillment contracts with group purchasing organizations, or GPOs, home care companies, alternate infusion sites, hospital groups and others. We are highly dependent on these agreements for the successful sale, distribution and delivery of our products. For example, we rely principally on GPOs and on our distributors to sell our IVIG products. If such parties breach, terminate or otherwise fail to perform under these contracts, our ability to effectively distribute our products will be impaired and our business may be materially and adversely affected. In addition, through circumstances outside of our control, such as general economic decline, market saturation or increased competition, we may be unable to successfully renegotiate our contracts or secure terms which are as favorable to us. Furthermore, we rely in certain countries on distributors for sales of our products. Disagreements or difficulties with our distributors supporting our export business could result in a loss of sales.

We may not be able to commercialize products in development.

Before obtaining regulatory approval for the sale of our product candidates or for the marketing of existing products for new indicated uses, we must conduct, at our own expense, extensive preclinical tests to demonstrate the safety of our product candidates in animals and clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Preclinical and clinical testing is expensive, is difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more of our clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during, or as a result of, preclinical testing and the clinical trial process that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates, including, without limitation:

· regulators or institutional review boards, or IRBs, may not authorize us to commence a clinical trial or conduct a clinical trial within a country or at a prospective trial site;

· the regulatory requirements for product approvals may not be explicit, may evolve over time and may diverge by jurisdiction;

· our preclinical tests or clinical trials may produce negative or inconclusive results, and we may decide, or we may be required by regulators, to conduct additional preclinical testing or clinical trials or to abandon projects that we had expected to be promising;

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· the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower than we anticipate or participants may withdraw from our clinical trials at higher rates than we anticipate, any of which would result in significant delays;

· our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;

· we may be forced to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks or if any participant experiences an unexpected serious adverse event;

· regulators or IRBs may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;

· undetected or concealed fraudulent activity by a clinical researcher, if discovered, could preclude the submission of clinical data prepared by that researcher, lead to the suspension or substantive scientific review of one or more of our marketing applications by regulatory agencies and result in the recall of any approved product distributed pursuant to data determined to be fraudulent;

· the cost of our clinical trials may be greater than we anticipate;

· the supply or quality of our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate, as we currently do not have any agreements with third-party manufacturers for the long-term commercial supply of any of our product candidates;

· an audit of preclinical or clinical studies by the FDA or other regulatory authorities may reveal noncompliance with applicable regulations, which could lead to disqualification of the results and the need to perform additional studies; and

· the effects of our product candidates may not achieve the desired clinical benefits or may cause undesirable side effects, or the product candidates may have other unexpected characteristics.

If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete our clinical trials or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may be delayed in or unable to obtain marketing approval or reimbursement for our product candidates, or be unable to obtain approval for indications that are not as broad as intended or have the product removed from the market after obtaining marketing approval.

Our product development costs will also increase if we experience delays in testing or approvals. We do not know whether any preclinical tests or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, if at all. Significant preclinical or clinical trial delays also could shorten the patent protection period during which we may have the exclusive right to commercialize our product candidates or could allow our competitors to bring products to market before we do, impairing our ability to commercialize our products or product candidates.

Even if preclinical trials are successful, we still may be unable to commercialize a product due to difficulties in obtaining regulatory approval for its engineering process or problems in scaling that process to commercial production. Additionally, if produced, a product may not achieve an adequate level of market acceptance by physicians, patients, healthcare payors and others in the medical community to be profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, some of which are beyond our control, including:

· the prevalence and severity of any side effects;

· the efficacy and potential advantages over alternative treatments;

· the ability to offer our product candidates for sale at competitive prices;

· relative convenience and ease of administration;

· the willingness of physicians to prescribe new therapies and of the target patient population to try such therapies;

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· the strength of marketing and distribution support; and

· sufficient third-party coverage or reimbursement.

Therefore, we cannot guarantee that any products we may seek to develop will ever be successfully commercialized, and to the extent they are not successfully commercialized, such products could involve significant expense with no corresponding revenue.

A breakdown in our information technology systems could result in a significant disruption to our business.

Our operations are highly dependent on our information technology systems, including internet-based systems, which may be vulnerable to breakdown, wrongful intrusions, data breaches and malicious attack. In addition, information security risks have generally increased in recent years, increasing our systems’ potential vulnerability, such as to data security breaches or cyber attack, whether by employees or others, which may expose sensitive data to unauthorized persons. Such data security breaches could lead to the loss of trade secrets or other intellectual property, or could lead to the public exposure of personal information (including sensitive personal information) of our employees, customers, plasma donors and others or adversely impact the conduct of scientific research and clinical trials, including the submission of research results to support marketing authorizations. Various evolving federal, state and foreign laws protecting the privacy and security of personal information may also be implicated by improper uses or disclosures of data, resulting in liabilities and requiring specified data breach notifications. For example, the privacy and security provisions of the federal Health Insurance Portability and Accountability Act of 1996, as amended, and implementing regulations (“HIPAA”) requires, among other things, the implementation of various recordkeeping, operational, notice and other practices intended to safeguard certain personal information, limit its use to allowed purposes and notify individuals in the event of privacy and security breaches. Failure to comply with HIPAA and similar state laws could expose us to breach of contract claims, substantial fines, penalties and other liabilities and expenses, costs for remediation and harm to our reputation. Also, the European Parliament and the Council of the European Union have adopted a new pan-European General Data Protection Regulation (“GDPR”), effective from May 25, 2018, which increased privacy rights for individuals in Europe, extended the scope of responsibilities for data controllers and data processors and imposed increased requirements and potential penalties on companies offering goods or services to individuals who are located in Europe or monitoring the behavior of such individuals (including by companies based outside of Europe). Noncompliance can result in penalties of up to the greater of EUR 20 million, or 4% of global company revenues. Our efforts to implement programs and controls that comply with the GDPR and other data protection requirements are likely to impose additional costs on us, and we cannot predict whether the interpretations of the requirements, or changes in our practices in response to new requirements or interpretations of the requirements, could have a material adverse effect on our business. Our information technology systems also utilize certain third party service organizations that manage sensitive data, such as personal medical information regarding plasma donors, and our business may be adversely affected if these third party service organizations are subject to data security breaches.

Our success depends in large part on our ability to obtain and maintain protection in the United States and other countries of the intellectual property relating to or incorporated into our technology and products.

Our success depends in large part on our ability to obtain and maintain protection in the United States and other countries for the intellectual property covering or incorporated into our technology and products, especially intellectual property related to our purification processes. The patent situation in the field of biotechnology and pharmaceuticals generally is highly uncertain and involves complex legal and scientific questions. We may not be able to obtain additional issued patents relating to our technology or products. Even if patents are issued to us or to our licensors, they may be challenged, narrowed, invalidated, held to be unenforceable or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length of time our products have patent protection. Additionally, most of our patents relate to the processes we use to produce our products, not to the products themselves. In many cases, the plasma-derived products we produce or develop in the future will not, in and of themselves, be patentable. Since our patents relate to processes, if a competitor is able to design and utilize a process that does not rely on our protected intellectual property, that competitor could sell a plasma-derived or other product similar to one we developed or sell.

Our patents also may not afford us protection against competitors with similar technology. Because patent applications in the United States and many other jurisdictions are typically not published until 18 months after their filing, if at all, and because publications of discoveries in the scientific literature often lag behind actual discoveries, neither we nor our licensors can be certain that we or they were the first to make the inventions claimed in our or their issued patents or pending patent applications, or that we or they were the first to file for protection of the inventions set forth in such patent applications. If a third party has also filed a U.S. patent application covering our product candidates or a similar invention, we may be required to participate in an adversarial proceeding, known as an “interference proceeding,” declared by the U.S. Patent and Trademark Office to determine priority of invention in the United States. The costs of these proceedings could be substantial and our efforts in them could be unsuccessful, resulting in a loss of our anticipated U.S. patent position.

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Our patents expire at various dates. Our pending and future patent applications may not issue as patents or, if issued, may not issue in a form that will provide us with any competitive advantage. Even if issued, we cannot guarantee that: any of our present or future patents or patent claims or other intellectual property rights will not lapse or be invalidated, circumvented, challenged or abandoned; our intellectual property rights will provide competitive advantages; our ability to assert our intellectual property rights against potential competitors or to settle current or future disputes will not be limited by our agreements with third parties; any of our pending or future patent applications will be issued or have the coverage originally sought; our intellectual property rights will be enforced in jurisdictions where competition may be intense or where legal protection may be weak; or we will not lose the ability to assert our intellectual property rights against, or to license our technology to, others and collect royalties or other payments. In addition, our competitors or others may design around our protected patents or technologies.

Effective protection of our intellectual property rights may be unavailable, limited or not applied for in some countries. Changes in patent laws or their interpretation in the United States and other countries could also diminish the value of our intellectual property or narrow the scope of our patent protection. In addition, the legal systems of certain countries do not favor the aggressive enforcement of patents, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. In order to preserve and enforce our patent and other intellectual property rights, we may need to make claims or file lawsuits against third parties. Such lawsuits could entail significant costs to us and divert our management’s attention from developing and commercializing our products.

We, like other companies in the pharmaceutical industry, may become aware of counterfeit versions of our products becoming available domestically and abroad. Counterfeit products may use different and possibly contaminated sources of plasma and other raw materials, and the purification process involved in the manufacture of counterfeit products may raise additional safety concerns, over which we have no control. Any reported adverse events involving counterfeit products that purport to be our products could harm our reputation and the sale of our products in particular and consumer willingness to use plasma-derived therapeutics in general.

Unauthorized use of our intellectual property may have occurred or may occur in the future. Although we have taken steps to minimize this risk, any failure to identify unauthorized use and otherwise adequately protect our intellectual property would adversely affect our business. For example, any unauthorized use of our trademarks could harm our reputation or commercial interests. Moreover, if we are required to commence litigation related to unauthorized use, whether as a plaintiff or defendant, such litigation would be time consuming, force us to incur significant costs and divert our attention and the efforts of our management and other employees, which could, in turn, result in lower revenue and higher expenses.

In addition to patented technology, we rely on our unpatented proprietary technology, trade secrets, processes and know-how.

We generally seek to protect proprietary information by entering into confidentiality agreements with our employees, consultants, scientific advisors and third parties. These agreements may not effectively prevent disclosure of confidential information, may be limited as to their term and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, our trade secrets may otherwise become known or be independently developed by our competitors or other third parties. To the extent that our employees, consultants or contractors use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. Costly and time-consuming litigation could be necessary to determine and enforce the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position. We also rely on contractual protections with our customers, suppliers, distributors, employees and consultants and implement security measures designed to protect our trade secrets. We cannot assure you that these contractual protections and security measures will not be breached, that we will have adequate remedies for any such breach or that our suppliers, employees or consultants will not assert rights to intellectual property arising out of such contracts.

Since we rely on trade secrets and nondisclosure agreements, in addition to patents, to protect some of our intellectual property, there is a risk that third parties may obtain and improperly utilize our proprietary information to our competitive disadvantage. We may not be able to detect the unauthorized use of such information, prevent such use or take appropriate and timely steps to enforce our intellectual property rights.

We may infringe or be alleged to infringe intellectual property rights of third parties.

Our products or product candidates may infringe or be accused of infringing one or more claims of an issued patent or may fall within the scope of one or more claims in a published patent application that may be subsequently issued and to which we do not hold a license or other rights. Third parties may own or control these patents or patent applications in the United States and/or abroad. These third parties could bring claims against us or our collaborators that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages. Further, if a patent infringement suit were brought against us or our

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collaborators, we or they could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit.

If we are found to be infringing on the patent rights of a third party, or in order to avoid potential claims, we or our collaborators may choose or be required to seek a license from a third party and be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we or our collaborators were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened patent infringement claims, we or our collaborators are unable to enter into licenses on acceptable terms.

There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. In addition to infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference proceedings declared by the U.S. Patent and Trademark Office and opposition proceedings in the European Patent Office, regarding intellectual property rights with respect to our products. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.

Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We take steps to ensure that our employees do not use the proprietary information or know-how of others in their work for us. We may, however, be subject to claims that we or these employees have inadvertently or otherwise used or disclosed intellectual property, trade secrets or other proprietary information of any such employee’s former employer. Litigation may be necessary to defend against these claims and, even if we are successful in defending ourselves, could result in substantial costs to us or be distracting to our management. If we fail to defend any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

We have in-licensed certain patent rights and co-own certain patent rights with third parties.

Our rights in certain intellectual property that we have in-licensed or co-own with third parties and the value therein may depend on our third party licensors’ or co-owners’, as applicable, performance under our intellectual property agreements with them. If one of these third parties is unable to, or does not, enforce their own rights in such intellectual property or perform under our agreements with them, it could affect our ability to effectively compete in the marketplace and operate our business.

Our in-license agreements for certain patent rights may impose payment and/or other material obligations on us as a licensee. Although we are currently in compliance with all of our material obligations under these licenses, if we were to breach any such obligations, our counterparty licensors may be entitled to terminate the licenses. Such termination may restrict, delay or eliminate our ability to develop and commercialize our products, which could adversely affect our business. We cannot guarantee that the third-party patents and technology we license will not be licensed to our competitors. In the future, we may need to obtain additional licenses, renew existing license agreements or otherwise replace existing technology. We are unable to predict whether these license agreements can be obtained or renewed or whether the technology can be replaced on acceptable terms, or at all.

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Risks Relating to the Healthcare Industry

The implementation of the Healthcare Reform Law in the United States may adversely affect our business.

The United States Healthcare Reform Law, adopted through the March 2010 enactment of the Patient Protection and Affordable Care Act and the companion Healthcare and Education Reconciliation Act, increased federal oversight of private health insurance plans and included a number of provisions designed to reduce Medicare expenditures and the cost of health care generally, to reduce fraud and abuse, and to provide access to increased health coverage. While the Healthcare Reform Law has materially expanded the number of individuals in the United States with health insurance, the Healthcare Reform Law has faced ongoing legal challenges, including litigation seeking to invalidate some of or all of the law or the manner in which it has been interpreted. For example, while upholding the law generally, the United States Supreme Court has effectively made the Healthcare Reform Law’s Medicaid expansion voluntary for each state. In addition, President Trump is seeking to repeal and replace the Healthcare Reform Law, and has taken a number of administrative actions to materially weaken the Healthcare Reform Law. For example, on January 20, 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the Healthcare Reform Law to limit the implementation of any provision of the Healthcare Reform Law that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices. Further, on December 22, 2017, President Trump signed into law H.R.1, commonly referred to as the Tax Cuts and Jobs Act, which significantly changed the Internal Revenue Code, including a reduction in the corporate income tax rate, a new limitation on the deductibility of interest expense, a new tax on certain deductible payments made by a U.S. corporation to its foreign affiliates in order to prevent base erosion and significant changes to the taxation of income earned from foreign sources and foreign subsidiaries. The Tax Cuts and Jobs Act also repealed the individual mandate of the Healthcare Reform Law, which has been viewed as important to the fiscal viability of the Healthcare Reform Law. Additionally, in December 2018, a Texas federal court struck down the entire Healthcare Reform Law, a ruling which is now being appealed, and, if upheld, could have a significant impact on the United States healthcare industry. The uncertain status of the Healthcare Reform Law affects our ability to plan, and its repeal without adequate replacement could have a material adverse effect on our United States operations.

Implementation of the Healthcare Reform Law has included significant cost-saving, revenue and payment reduction measures with respect to, for example, several government healthcare programs that cover our products, including Medicaid, Medicare Parts B and D and the 340B/Public Health Service, or PHS, program, and these efforts could have a material adverse impact on our financial performance. For more details of these measures see Item 4 of this Part I, “Information on the Company — E. Regulatory Matters — Pharmaceutical Pricing and Reimbursement.”

The availability of federal funds to pay for our products under Medicaid and Medicare Part B programs requires that we extend discounts under the 340B/PHS program, and changes to this program under the Healthcare Reform Law could adversely affect our financial performance. The 340B/PHS program extends discounts to a variety of community health clinics and other entities that receive health services grants from the PHS, as well as hospitals that serve a disproportionate share of certain low income individuals, and the Healthcare Reform Law expanded the number of qualified 340B entities eligible to purchase products for outpatient use, adding certain cancer centers, children’s hospitals, critical access hospitals and rural referral centers. The PHS price, or ceiling price, cannot exceed the AMP (as reported to CMS under the Medicaid drug rebate program) less the Medicaid unit rebate amount. We have entered into a pharmaceutical pricing agreement, or PPA, with the government in which we have agreed to participate in the 340B/PHS program by charging eligible entities no more than the PHS ceiling price for drugs intended for outpatient use. Evolving requirements with respect to this program continue to be issued by the Health Resources and Services Administration, or HRSA, of HHS, the federal agency responsible for oversight of the 340B/PHS program, which creates uncertainty. For example, effective January 5, 2019, a final HRSA rule codified standards regarding the calculation of the ceiling price for covered outpatient drugs under the 340B/PHS program, as well as regarding the imposition of civil monetary penalties, or CMPs, on manufacturers that knowingly and intentionally overcharge covered entities. In another development, effective January 1, 2018, a new CMS rule went into effect substantially cutting reimbursement paid to hospitals and other providers for certain outpatient drugs and biologicals, including certain of our products, if purchased by these providers under the 340B/PHS program. The reimbursement was decreased from ASP plus 6% to ASP minus 22.5%. However, on December 27, 2018, the Federal District Court for the District of Columbia issued an opinion finding that this reimbursement cut exceeded CMS’s regulatory authority. No final remedy has yet resulted from this decision, and the case remains subject to appeal. The outcome of this reimbursement change on our business is uncertain, but it may decrease demand for our products and have an adverse effect on our business. We believe that we meet the requirements of the 340B/PHS program, and are continuing to review and monitor these and other developments affecting the 340B/PHS program.

The Healthcare Reform Law also introduced a new abbreviated regulatory approval pathway for biological products found to be “biosimilar” to or “interchangeable” with a biological “reference product” previously licensed under a BLA. This abbreviated approval pathway is intended to permit a biosimilar product to come to market more quickly and less expensively by relying to some extent on the data generated by the reference product’s sponsor, and the FDA’s previous review and approval of the reference product.

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The law provides that no biosimilar application may be accepted for FDA review until 4 years after the date the reference product was first licensed by the FDA, and that the FDA may not make approval of an application effective until 12 years after the reference product was first licensed. Once approved, biosimilars likely would compete with, and in some circumstances may be deemed under applicable laws to be “interchangeable with,” the previously approved reference product. The extent to which a biosimilar product, once approved, will be substituted for any of our products, in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. The FDA is actively seeking to encourage the entry of biosimilars into the marketplace, including issuing, in July 2018, its Biosimilar Action Plan, intended to enhance the speed of the biosimilar development and approval processes. We expect in the future to face greater competition from biosimilar products, including a possible increase in patent challenges, all of which could adversely affect our financial performance.

Regarding access to our products, the Healthcare Reform Law established and provided significant funding for a Patient-Centered Outcomes Research Institute to coordinate and fund Comparative Effectiveness Research, as those terms are defined in the Healthcare Reform Law. While the stated intent of Comparative Effectiveness Research is to develop information to guide providers to the most efficacious therapies, outcomes of Comparative Effectiveness Research could influence the reimbursement or coverage for therapies that are determined to be less cost effective than others. Should any of our products be determined to be less cost effective than alternative therapies, the levels of reimbursement for these products, or the willingness to reimburse at all, could be impacted, which could materially impact our financial results.

A Healthcare Reform Law provision, generally referred to as the Physician Payment Sunshine Act, or the PPS Act, or Open Payments Program, has imposed new reporting and disclosure requirements for biologic, drug and device manufacturers with regard to payments or other transfers of value made to certain practitioners, such as physicians and teaching hospitals, and for such manufacturers and for group purchasing organizations, with regard to certain ownership interests held by physicians in the reporting entity. CMS publishes information from these reports on a publicly available website, including amounts transferred and health care provider identities. Under the PPS Act we are required to collect and report detailed information regarding certain financial relationships we have with covered health care providers. The PPS Act pre-empts similar state reporting laws, although we or our subsidiaries may also be required to report under certain state transparency laws that address circumstances not covered by the PPS Act, and some of these state laws are also ambiguous. We are also subject to foreign regulations requiring transparency of certain interactions between suppliers and their customers. While we believe we have substantially compliant programs and controls in place to comply with these reporting requirements, we cannot assure you that regulations will not require us to take additional compliance steps. Our compliance with these rules imposes additional costs on us.

We could be adversely affected if other government or private third-party payors decrease or otherwise limit the amount, price, scope or other eligibility requirements for reimbursement for the purchasers of our products.

Certain of our products are subject to various cost-containment measures, such as government-imposed industry-wide price reductions, mandatory pricing systems, reference pricing systems, payors limiting access to treatments based on cost-benefit analyses, an increase in imports of drugs from lower-cost countries to higher-cost countries, shifting of the payment burden to patients through higher co-payments, limiting physicians’ ability to choose among competing medicines, mandatory substitution of generic drugs for the patented equivalent, and growing pressure on physicians to reduce the prescribing of patented prescription medicines. Such pressures could have a material adverse impact on our business, financial condition or results of operations, as well as on our reputation.

For example, certain pharmaceutical products, such as plasma derivative products, are subject to price controls in several of our principal markets, including Spain and countries within the European Union. In the United States, where pricing levels for our products are established by governmental payors and negotiated with private third-party payors, if the amount of reimbursement available for a product is reduced, it may cause groups or individuals dispensing the product to discontinue administration of the product, to administer lower doses, to substitute lower cost products or to seek additional price-related concessions. These actions could have a negative effect on our financial results, particularly in cases where our products command a premium price in the marketplace or where changes in reimbursement induce a shift in the location of treatment. The existence of direct and indirect price controls and pressures over our products has affected, and may continue to materially adversely affect, our ability to maintain or increase gross margins. In addition, the growth of overall healthcare costs and certain weak economic and financial environment in certain countries where we do business, as well as increased scrutiny over pharmaceutical pricing practices, such as in the United States, all enhance these pricing pressures.

In the United States, beginning in 2005, the Medicare drug reimbursement methodology for physician and hospital outpatient payment schedules changed to Average Sales Price, or ASP, + 6%. This payment was based on a volume-weighted average of all brands under a common billing code. After changes in certain prior years, CMS increased the rate back to ASP + 6% for 2013, and maintained the same rate for 2014 through 2018, except that effective January 1, 2018, a new CMS rule went into effect cutting

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reimbursement paid to hospitals and other providers for certain outpatient drugs and biologicals, including certain of our products to ASP -22.5%, if purchased by these providers under the 340B/PHS program, although this reimbursement cut is being challenged in the courts, and the outcome of that challenge is uncertain. The outcome of this 340B/PHS program reimbursement change on our business is uncertain, but it may decrease demand for our products and have an adverse effect on our business. In addition, under the Bipartisan Budget Act of 2013, and subsequent measures, Medicare is subject to a 2% reduction in federal spending, or “sequestration,” including drugs reimbursed under Medicare, for federal fiscal years 2013 through 2025. The full ramifications of this sequestration for Medicare reimbursement are not yet clear, as Congressional action may reduce, eliminate or otherwise change this payment reduction.

Other pricing concerns in the United States include that in May 2018, President Trump released a drug “blueprint” including an array of policy ideas intended to lower drug prices and patient out-of-pocket drug costs, and federal administrative agencies have begun issuing proposed regulations to adopt various of these proposals. An area of focus are drugs reimbursed under Medicare Part B. The proposals include, for example, moving reimbursement for certain Medicare Part B drugs into Medicare Part D to make them subject to a variety of pricing negotiations, establishing an enhanced competitive acquisition program for Medicare Part B drugs, and instituting an “International Pricing Index” payment model that would link reimbursement for certain Medicare Part B drugs to pricing levels for such drugs found in other countries. Other proposals support the marketing of biosimilars, involve lowering standards for demonstrating biosimilarity. One additional proposal, which was published as a proposed rule by the Office of Inspector General of the Department of Health and Human Services on February 6, 2019, and is focused initially on drugs reimbursed under Medicare Part D and certain Medicaid managed care organizations (although comments were sought as to whether its scope should be expanded, including to Medicare Part B drugs), would substantially disrupt current pharmaceutical market practices by apparently rendering illegal, under the federal Anti-Kickback Statute, many drug rebates now routinely paid by drug manufacturers to such health benefit plans or their pharmacy benefit managers (PBMs). The uncertain status of these various pricing proposals, some of which could take effect based on action by federal administrative agencies without the need for Congressional action, affects our ability to plan, and the proposals, if adopted, in whole or in part, could adversely affect our business.

An increasing number of states in the United States have also proposed or passed legislation that seeks to directly or indirectly regulate pharmaceutical drug pricing, such as by requiring drug manufacturers to publicly report pricing information or to place a maximum price ceiling on pharmaceutical products purchased by state agencies. For example, in October 2017, California enacted a prescription drug price transparency law that requires prescription drug manufacturers to provide advance notice and explanation for certain drug price increases that exceed a specified threshold. Laws of this type may cause us to experience additional pricing pressures on our affected products, and could adversely affect our business.

Also, the intended use of a drug product by a physician can affect pricing. Physicians frequently prescribe legally available therapies for uses that are not described in the product’s labeling and that differ from those tested in clinical studies and that are approved by the FDA or similar regulatory authorities in other countries. These off-label uses are common across medical specialties, and physicians may believe such off-label uses constitute the preferred treatment or treatment of last resort for many patients in varied circumstances. Industry data indicates that a significant portion of IVIG volume may be used to fill physician prescriptions for indications not approved by the FDA or similar regulatory authorities. In the United States, many off-label uses of drug products may be reimbursed by Medicare and other third-party payors, generally based on the payors’ determination that the intended use is for a medically accepted indication, for example, based on studies published in peer-reviewed medical journals or information contained in drug compendia, such as the United States Pharmacopeia-National Formulary. However, if reimbursement for off-label uses of products, including IVIG, is reduced or eliminated by Medicare or other third-party payors, including those in the United States or the European Union, we could be adversely affected. For example, CMS could initiate an administrative procedure known as a National Coverage Determination by which the agency determines which uses of a therapeutic product would be reimbursable under Medicare and which uses would not. This determination process can be lengthy, thereby creating a long period during which the future reimbursement for a particular product may be uncertain. High levels of spending on IVIG products, along with increases in IVIG prices, increased IVIG utilization and the high proportion of off-label uses, may increase the risk of regulation of IVIG reimbursement by CMS. On the state level, similar limits could be proposed for therapeutic products covered under Medicaid.

Certain of our business practices are subject to scrutiny by regulatory authorities, as well as to lawsuits brought by private citizens under federal and state laws. Failure to comply with applicable laws or an adverse decision in lawsuits may result in adverse consequences to us.

The laws governing our conduct in the United States are enforceable by criminal, civil and administrative penalties. Violations of laws such as the Federal Food, Drug and Cosmetic Act, or the FDCA, the Federal False Claims Act, or the FCA, the PHS Act or provisions of the U.S. Social Security Act known as the “Anti-Kickback Law” and the “Civil Monetary Penalties Law,” or any regulations promulgated under their authority, may result in jail sentences, fines or exclusion from federal and state programs, as may be determined by Medicare, Medicaid, the Department of Defense, other regulatory authorities and the courts. There can be no assurance that our activities will not come under the scrutiny of regulators and other government authorities or that our practices will

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not be found to violate applicable laws, rules and regulations or prompt lawsuits by private citizen “relators” under federal or state false claims laws. For a description of anti-fraud and abuse laws see Item 4 of this Part I, “Information on the Company — E. Regulatory Matters, Government Regulation, United States Government Regulation, Anti-fraud and Abuse Regulation.”

Failure to comply with fraud and abuse laws and regulations could also result in other significant civil and criminal penalties and costs, including the loss of licenses and the ability to participate in federal and state health care programs, and could have a material adverse effect on our business. In addition, these measures may be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that could require us to make changes in our operations or incur substantial defense and settlement expenses. Even unsuccessful challenges by regulatory authorities or private relators could result in reputational harm and the incurring of substantial costs. Further, many of these laws are vague or indefinite and have not been interpreted by the courts, and have been subject to frequent modification and varied interpretation by prosecutorial and regulatory authorities, increasing the risk of noncompliance. While we believe that we are substantially compliant with applicable fraud and abuse laws and regulations, and have adequate compliance programs and controls in place to ensure substantial compliance, we cannot predict whether changes in applicable law, or interpretation of laws, or changes in our services or marketing practices in response to changes in applicable law or interpretation of laws, could have a material adverse effect on our business.

Failure to satisfy requirements under the FDCA can also result in penalties, as well as requirements to enter into consent decrees or orders that prescribe allowable corporate conduct. In this regard, our Los Angeles facility was previously managed pursuant to a consent decree that was entered into in February 1998 based on action by the FDA and the U.S. Department of Justice, or the DOJ, addressing FDCA violations committed by the former owner of the facility, Alpha Therapeutic Corporation, or Alpha. The consent decree provided for annual inspection of the plant by the FDA. On March 15, 2012, the United States District Court for the Central District of California entered an order vacating the consent decree on the Los Angeles facility.

Adverse consequences can also result from failure to comply with the requirements of the 340B/PHS program under the PHS Act, which extends discounts to a variety of community health clinics and other entities that receive health services grants under the PHS Act. For example, the Healthcare Reform Law requires the Secretary of HHS to develop and issue regulations for the 340B/PHS program establishing standards for the imposition of sanctions in the form of civil monetary penalties, or CMP, for manufacturers that knowingly and intentionally overcharge a covered entity for a 340B/PHS program drug, and effective January 1, 2019, a final HRSA rule codified these CMP standards. Under the rule, the CMP may be up to $5,000 for each instance of overcharging a covered entity.

In addition, companies in the United States, Canada and the European Union are generally restricted from promoting approved products for other indications that are not specifically approved by the competent regulatory authorities (e.g., the FDA in the United States), nor can companies promote unapproved products. In the United States, pharmaceutical companies have, to a limited extent, been recognized by the FDA as permitted to disseminate to physicians certain truthful and accurate information regarding unapproved uses of approved products, or results of studies involving investigational products. In addition, in December 2012, a federal appeals court in New York found that the criminal prosecution of a pharmaceutical manufacturer for truthful, non-misleading speech promoting the lawful, off-label use of an FDA-approved drug would violate the manufacturer’s constitutional rights of free speech, and the FDA chose not to appeal that decision. Improper promotion of unapproved drugs or devices or unapproved indications for a drug or device may subject us to warnings from, or enforcement action by, regulatory agencies, harm demand for our products, and subject us to civil and criminal sanctions. Further, sanctions under the FCA have recently been brought against companies accused of promoting off-label uses of drugs, because such promotion induces the use and subsequent claims for reimbursement under Medicare and other federal programs. Similar actions for off-label promotion have been initiated by several states for Medicaid fraud. The Healthcare Reform Law significantly strengthened provisions of the FCA, the anti-kickback provisions of Medicare and Medicaid and other health care antifraud provisions, leading to the possibility of greatly increased qui tam suits by relators for perceived violations. Industry data indicates that a significant portion of IVIG volume may be used to fill physician prescriptions for indications not approved by the FDA or similar regulatory authorities. Violations or allegations of violations of the foregoing restrictions could materially and adversely affect our business.

We are required to report detailed pricing information, net of included discounts, rebates and other concessions, to CMS for the purpose of calculating national reimbursement levels, certain federal prices and certain federal and state rebate obligations. We have established systems for collecting and reporting this data accurately to CMS and have instituted a compliance program to assure that the information collected is complete in all respects. If we report pricing information that is not accurate to the federal government, we could be subject to fines and other sanctions (including potential FCA liability) that could adversely affect our business.

To market and sell our products outside of the United States, we must obtain and maintain regulatory approvals and comply with regulatory requirements in such jurisdictions. The approval procedures vary among countries in complexity and timing. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all, which would preclude us from commercializing products in those markets. In addition, some countries, particularly the countries of the European Union, regulate the pricing of prescription pharmaceuticals. In these countries, pricing discussions with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be

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required to conduct a clinical trial that compares the cost effectiveness of our product candidate to other available therapies. Such trials may be time consuming and expensive and may not show an advantage in efficacy for our products. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, in either the United States or the European Union, we could be adversely affected.

We also are subject to certain laws and regulations concerning the conduct of our foreign operations outside the United States, including the U.S. Foreign Corrupt Practices Act, or FCPA, and other anti-bribery laws and related laws, and laws pertaining to the accuracy of our internal books and records, which have been the focus of increasing enforcement activity in recent years. Under the FCPA, the United States has increasingly focused on regulating the conduct by U.S. businesses occurring outside of the United States, generally prohibiting remuneration to foreign officials for the purpose of obtaining or retaining business. Also, in some countries we may rely on third parties for the marketing and distribution of our products, and these parties may lack sufficient internal compliance resources, and may operate in foreign markets involving substantial corruption. If our efforts to monitor these parties fail to detect potential wrongdoing, we could be held responsible for the noncompliance of these third parties with applicable laws and regulations, which may have a material adverse effect on our business.

We are subject to extensive government regulatory compliance and ethics oversight.

Our business is subject to extensive government regulation and oversight. We have enacted anticorruption, privacy, healthcare and corporate compliance policies and procedures that govern our business practices and those of our distributors and suppliers. These policies and procedures are effectuated through education, training and monitoring of our employees, distributors and suppliers. In addition, to enhance compliance with applicable health care laws and mitigate potential liability in the event of noncompliance, regulatory authorities, such as HHS’s Office of the Inspector General, or OIG, have recommended the adoption and implementation of a comprehensive health care compliance program that generally contains the elements of an effective compliance and ethics program described in Section 8B2.1 of the U.S. Sentencing Commission Guidelines Manual. Increasing numbers of U.S.-based pharmaceutical companies have such programs, and we have adopted U.S. healthcare compliance and ethics programs that generally incorporate the HHS OIG’s recommendations. However, our adoption and enforcement of these various policies and procedures does not ensure that we will avoid investigation or the imposition of penalties by applicable government agencies.

We are subject to extensive environmental, health and safety laws and regulations.

Our business involves the controlled use and the generation, handling, management, storage, treatment and disposal of hazardous substances, wastes and various biological compounds and chemicals. The risk of contamination or injury from these materials cannot be eliminated. If an accident, spill or release of any regulated chemicals, substances or wastes occurs, we could be held liable for resulting damages, including for investigation, remediation and monitoring of the contamination, including natural resource damages, the costs of which could be substantial. As owners and operators of real property, we could also be held liable for the presence of hazardous substances as a result of prior site uses or activities, without regard to fault or the legality of the original conduct that caused or contributed to the presence or release of such hazardous substance on, at, under or from our property. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials, chemicals and wastes.

Although we maintain workers’ compensation insurance to cover the costs and expenses that may be incurred due to injuries to our employees resulting from the use and handling of these materials, chemicals and wastes, this insurance may not provide adequate coverage against potential liabilities.

Additional or more stringent federal, state, local or foreign laws and regulations affecting our operations may be adopted in the future. We may incur substantial capital costs and operating expenses to comply with any of these laws or regulations and the terms and conditions of any permits required pursuant to such laws and regulations, including costs to install new or updated pollution control equipment, modify our operations or perform other corrective actions at our respective facilities. In addition, fines and penalties may be imposed for noncompliance with environmental and health and safety laws and regulations or for the failure to have or comply with the terms and conditions of required environmental permits.

Item 4. INFORMATION ON THE COMPANY

A. History of and Development of the Company

Introduction

We were founded in 1940 in Barcelona, Spain by Dr. José Antonio Grifols i Roig, a specialist and pioneer in blood transfusions and clinical analysis and the grandfather of our current Chairman of the Board. We have been making and selling plasma

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derivative products for more than 70 years. Over the last 25 years, we have grown from a predominantly domestic Spanish company into a global company by expanding both organically and through acquisitions throughout Europe, the United States, Latin America and Asia.

We were incorporated in Spain as a limited liability company on June 22, 1987 under the name Grupo Grifols, S.A., and we changed our name to Grifols, S.A. in 2005. We conduct business under the commercial name “Grifols.” Our principal executive office is located at Avinguda de la Generalitat, 152 Parque Empresarial Can Sant Joan, 08174 Sant Cugat del Vallès, Barcelona, Spain and our telephone number is +34 93 571 0500. Our registered office is located at c/Jesús y María, 6, Barcelona, Spain.

We are a vertically integrated global producer of plasma derivatives and we believe we rank in the top three largest producers in the industry. Our activities include sourcing raw material, manufacturing various plasma derivative products and selling and distributing final products to healthcare providers. We have expanded our plasma collection network and our manufacturing capacity through a combination of organic growth and acquisitions. As of December 31, 2018 we had 197 operating plasma collection centers located across the United States and a manufacturing capacity of approximately 14.8 million liters of plasma per year. In 2018, we also obtained the rights to all plasma collected at an additional 24 plasma centers in the United States and 35 plasma centers in Germany, See Item 5 of this Part I, “Operating and Financial Review and Prospects - A. Operating Results - Factors Affecting Our Financial Condition and Results of Operations - Acquisitions - Acquisition and Sale of Haema AG and Biotest Corporation” below. We plan to reach approximately 19 million liters fractionation capacity by 2021 and, as previously announced, 325 approved plasma collection centers globally by 2023.

We also research, develop, manufacture and market in vitro diagnostics products, including analytical instruments, reagents, software and associated products for use in clinical and blood bank laboratories and hospital products.

Our Class A shares have been listed on the Spanish Stock Exchanges since we completed our initial public offering on May 17, 2006 and are quoted on the SIBE under the ticker symbol “GRF.” In January 2008, we became part of the IBEX-35 Index, which comprises the top 35 listed Spanish companies by liquidity and market capitalization. Our Class B shares were issued as part of the consideration for the Talecris acquisition and are listed on the Spanish Stock Exchanges and quoted on the SIBE under the ticker symbol “GRF.P.” Our Class B shares are also traded in the United States on the NASDAQ Global Select Market in the form of ADSs, evidenced by ADRs, under the symbol “GRFS.” Each ADS represents one of our Class B shares. Our ADSs are currently traded in U.S. dollars. In November 2011, our ADSs were added to the NASDAQ Biotechnology Index.

Important Events

Acquisitions and Related Financing

The Shanghai RAAS Acquisition

On March 7, 2019, we entered into an Agreement for Assets Purchase by Share Issue with Shanghai RAAS Blood Products Co Ltd. (“Shanghai RAAS”), a leader in China’s plasma derivatives sector, which is listed on the Shenzhen Stock Exchange. Subject to regulatory approval, we will acquire 26.2% of the voting and economic rights(1) in Shanghai RAAS in exchange for a contribution of 45% of the economic rights and 40% of the voting rights in our U.S. subsidiary, Grifols Diagnostic Solutions Inc.

As part of the acquisition, we entered into an Exclusive Strategic Alliance Agreement pursuant to which Shanghai RAAS will be the exclusive distributor of our bioscience and diagnostic products in China. In exchange for royalties, we will provide technological and know-how support in the bioscience and diagnostic fields to Shanghai RAAS.

The Hologic Transaction and Related Financing

On December 14, 2016, we entered into an asset purchase agreement, or the Hologic Agreement, with Hologic to acquire Hologic’s NAT (nucleic acid testing) Donor Screening Unit. Prior to the transaction, we and Hologic jointly operated this business, with Hologic responsible for research and development and manufacturing of the Procleix® blood screening products and Grifols responsible for their commercialization worldwide. The transactions contemplated by the Hologic Agreement are referred to herein as the Hologic Transaction. The Hologic Transaction closed on January 31, 2017 and we paid a purchase price of $1.865 billion to Hologic.

In connection with the Hologic Transaction and the refinancing of the 2014 Credit Facilities (as defined herein), we (i) entered into a credit and guaranty agreement dated as of January 31, 2017, as amended, or the New Credit Facilities, which consists of senior term loans and revolving loans. As of the date of this annual report on Form 20-F, no amounts are drawn down on the Revolving Loans. See Item 5 of this Part I, “Operating and Financial Review and Prospects — B. Liquidity and Capital Resources —

(1) “economic rights” are defined as all rights attached to the shares except voting rights.

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Sources of Credit,” for terms of the New Credit Facilities, the 2017 Notes, European Investment Bank Term Loans and for more detailed information.

The Novartis Acquisition and Related Financing

On November 10, 2013, we entered into a share and asset purchase agreement, or the Novartis Agreement, with Novartis Vaccines and Diagnostics, Inc., or NVD, and, solely as a guarantor, Novartis Corporation, or Novartis, which was subsequently amended on December 27, 2013 and January 9, 2014, to acquire Novartis’ diagnostic business. The transactions contemplated by the Novartis Agreement are referred to herein as the Novartis Acquisition. We acquired from NVD a complete line of products and systems to perform blood donor screening molecular tests aimed at detecting the pathogenic agents of transfusion-related infectious diseases such as HIV, hepatitis B, hepatitis C and West Nile Virus. We paid a purchase price of $1.7 billion (€1.2 billion).

To finance the Novartis Acquisition, we entered into a credit and guaranty agreement with a syndicate led by Nomura Securities International, Inc., Banco Bilbao Vizcaya Argentaria, S.A., and Morgan Stanley Senior Funding, Inc., or the Bridge Loan Facility, pursuant to which we borrowed $1.5 billion of loans on January 3, 2014. The Bridge Loan Facility was refinanced pursuant to a credit and guaranty agreement dated as of February 27, 2014, as amended, or the 2014 Credit Facilities, which consisted of senior term loans and revolving loans.

The Talecris Acquisition

On June 1, 2011, pursuant to the Agreement and Plan of Merger, dated as of June 6, 2010, we completed the acquisition of 100% of the share capital of Talecris, a U.S.-based biotherapeutics products company, for a total of $3.7 billion. The total value of the transaction, including Talecris’ net debt, was approximately $3.3 billion.

For further details of our principal capital expenditures and divestitures, see Item 5 of this Part I, “Operating and Financial Review and Prospects — B. Liquidity and Capital Resources — Capital Expenditures.”

B. Business Overview

General

We are one of the leading global specialty pharmaceutical companies developing, manufacturing and distributing a broad range of biological medicines on plasma derived proteins. Plasma derivatives are proteins found in human plasma, which once isolated and purified, have therapeutic value. These protein-based therapies extend and enhance the lives of individuals who suffer from chronic and acute, often life-threatening, conditions, such as primary and secondary immunological deficiencies, Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP, A1PI deficiency and related emphysema, immune-mediated ITP, Guillain Barré syndrome, Kawasaki disease, allogeneic bone marrow transplants, hemophilia A and B, von Willebrand disease, traumatic or hemorrhagic shock and severe burns. In addition, we have built a diagnostic business that focuses on researching, developing, manufacturing and marketing in vitro diagnostics products for use in clinical and blood bank laboratories. We also specialize in providing infusion solutions, nutrition products and medical devices for use in hospitals and clinics.

Our products and services are used by healthcare providers in over 100 countries to diagnose and treat patients with hemophilia, immune deficiencies, infectious diseases and a range of other medical conditions, and we have a direct presence, through the operation of commercial subsidiaries, in 30 countries.

In 2017, we believe we ranked in the top three largest producers in the industry in terms of total sales globally. We believe we have a top three market position in various segments of the plasma derivatives industry including A1PI, IVIG, Factor VIII and albumin as well as in terms of plasma collection centers and fractionation capacity.

On January 31, 2017, we completed the acquisition of the business of Hologic Inc. related to the development, production and, pursuant to the collaboration described below, sale to us of products in connection with nucleic acid probe-based testing human blood, plasma, other blood products, human cells, organs or tissue intended for or associated with transfusion or transplantation. The transaction consisted of, among other things, the acquisition of the assets and liabilities related to this business and the termination of the then-existing collaboration agreement between Hologic and us for the joint development, manufacture, commercialization, marketing and sale of such products. The acquired business is now part of our Diagnostic division.

We organize our business into five divisions: Bioscience, Diagnostic, Hospital, Bio Supplies (formerly Raw Materials) and Others. These divisions also represent the operating segments of the Company.

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Bioscience. The Bioscience division includes activities relating to the manufacture of plasma derivatives for therapeutic use, including the reception, analysis, quarantine, classification, fractionation and purification of plasma and the sale and distribution of end products. The main plasma products we manufacture are IVIG, Factor VIII, A1PI and albumin. We also manufacture intramuscular (hyperimmune) immunoglobulins, ATIII, Factor IX and plasma thromboplastin component, or PTC. The Bioscience division accounted for €3.5 billion, or 78.4%, of our total net revenue in 2018.

Diagnostic. The Diagnostic division focuses on researching, developing, manufacturing and marketing in vitro diagnostics products, including analytical instruments, reagents, software and associated products for use in clinical and blood bank laboratories, covering the entire value chain from donation to transfusion. We concentrate our Diagnostic business in transfusion medicine (immunology, immunohematology) and specialty diagnostics such as hemostasis. The Diagnostic division’s main customers are blood donation centers, clinical analysis laboratories and hospital immunohematology services. The Diagnostic division accounted for €702.3 million, or 15.6%, of our total net revenue in 2018. The Nucleic Acid Testing, or NAT, Donor Screening Unit is engaged in research, development, manufacturing and commercialization of assays and instruments based on NAT technology for transfusion and transplantation screening. NAT technology makes it possible to detect the presence of infectious agents in blood and plasma donations, contributing to greater transfusion safety. We expect that the impact of the Hologic Transaction will enhance our vertical integration and further promote the development of new tests and screening routines for emerging viruses.

Hospital. The Hospital division manufactures products used by hospitals, as well as parenteral solutions and enteral nutritional fluids, which are sold almost exclusively in Spain and Portugal. It also includes products that we do not manufacture but that we market as supplementary to the products that we do manufacture. The Hospital division accounted for €119.4 million, or 2.7%, of our total net revenue in 2018.

Bio Supplies. Since January 2017, net revenue from Bio Supplies primarily consists of revenue related to biological products for non-therapeutic use previously recorded under the Bioscience segment as well as all income derived from manufacturing agreements with Kedrion and third party sales of Haema and Biotest. Since January 2017, net revenues also include all transactions related to biological products for non-therapeutic use previously recorded under the Bioscience segment. The Bio Supplies division accounted for €167.0 million, or 3.7%, of our total net revenue in 2018.

Others. Net revenue from Others primarily consists of revenue from the rendering of manufacturing services to third party companies.

Geographic Markets

We are a leading plasma derivatives producer globally, ranking in the top three largest producers in the industry in terms of total sales, along with Takeda and CSL Group. We are the world’s largest producer of A1PI, which is used for the treatment of A1PI deficiency-related emphysema.

We currently operate in over 100 countries through distributors and subsidiaries in 30 countries. The United States is the largest sales region in the world for the plasma derivative sector. For the year ended December 31, 2018, the United States and Canada accounted for 66.3% of our total net revenue while Europe accounted for 17.8% of our total net revenues (of which less than 6% was generated in Spain).

Certain sales regions, particularly in emerging markets, have experienced continuous growth, driven by enhanced socioeconomic conditions and more informed patients who are demanding better quality medical care, as well as increasing government healthcare spending on plasma derivative products. These emerging markets are expected to experience significant growth. Our presence and experience in Latin America, in countries such as Mexico, Colombia, Argentina, Chile and Brazil, where we have been marketing and selling products for over 20 years, has positioned us to benefit from this additional growth in both our Bioscience and Diagnostic divisions. In the Asia-Pacific region, we have established a presence through our subsidiaries and representative offices in Malaysia, China, Thailand, Singapore, Australia, Japan, India, Hong Kong, Taiwan and Indonesia. We have also opened a Middle Eastern representative office in Dubai.

Our continued focus on international expansion and acquisitions that generate operational synergies was demonstrated by our acquisition of Talecris in June 2011, a United States based producer of plasma-derived protein therapies with an established presence in the United States and Canada. We also expanded internationally with the acquisition in March 2013 of a 60% stake in Progenika (increased to 99.99% as of December 31, 2018), a Spanish biotechnology firm headquartered in Bilbao, with operations in the United States, Europe and the Middle East. The Novartis Acquisition further reinforced our international operations, as it expanded our global portfolio of brands, patents and licenses and gained us the Emeryville facility and commercial offices in the United States, as well as additional commercial offices in Switzerland and Hong Kong. Pursuant to the Hologic Transaction, we acquired our former joint-business partner’s NAT Donor Screening business, including a manufacturing facility in San Diego and development rights, product

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licenses and access to product manufacturers. In March 2019, we entered into an agreement to acquire a 26.2% stake in Shanghai RAAS. Subject to regulatory approval, pursuant to the agreement, Shanghai RAAS will become our exclusive distributor of plasma-derived products and transfusional diagnostic solutions in China. This acquisition reinforces our global expansion strategy and commercial presence in China. We will continue to selectively consider acquisitions that would further enhance our operations.

The following chart reflects a summary of net revenue by each of our geographic regions for the past three years:

Summary of Net Revenue by Region |  | Year ended December 31, 2018 |  | % of total net revenue |  | Year ended December 31, 2017 |  | % of total net revenue |  | Year ended December 31, 2016 (2) |  | % of total net revenue |
|  | (in thousands of euros, except for percentages) |
United States and Canada |  | 2,974,429 |  | 66.3 |  | 2,896,505 |  | 67.1 |  | 2,707,579 |  | 66.9 |
European Union(1) |  | 800,274 |  | 17.8 |  | 686,983 |  | 15.9 |  | 651,496 |  | 16.1 |
Rest of the World |  | 712,021 |  | 15.9 |  | 734,585 |  | 17.0 |  | 690,755 |  | 17.0 |
Total |  | 4,486,724 |  | 100.0 |  | 4,318,073 |  | 100.0 |  | 4,049,830 |  | 100.0 |

(1) Net revenue earned in the European Union includes net revenue earned in Spain.

(2) Comparable considering the new divisional structure that allocates “Raw Materials and Others” by region.

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Principal Activities

We organize our business into five divisions: Bioscience, Diagnostic, Hospital, Bio Supplies and Others. These divisions also represent the operating segments of the Company. The following chart presents our total net revenues by each of our divisions for the past three years:

Summary of Revenue by Division |  | Year ended December 31, 2018 |  | % of total net revenue |  | Year ended December 31, 2017 |  | % of total net revenue |  | Year ended December 31, 2016 (1) |  | % of total net revenue (1) |
|  | (in thousands of euros, except for percentages) |
Bioscience |  | 3,516,704 |  | 78.4 |  | 3,429,785 |  | 79.4 |  | 3,195,424 |  | 78.9 |
Diagnostic |  | 702,265 |  | 15.6 |  | 732,369 |  | 17.0 |  | 691,701 |  | 17.1 |
Hospital |  | 119,454 |  | 2.7 |  | 105,649 |  | 2.4 |  | 102,251 |  | 2.5 |
Bio Supplies |  | 167,004 |  | 3.7 |  | 66,791 |  | 1.6 |  | 57,239 |  | 1.4 |
Others |  | 22,451 |  | 0.5 |  | 18,263 |  | 0.4 |  | 34,601 |  | 0.9 |
Intersegments |  | (41,154 | ) | (0.9 | ) | (34,784 | ) | (0.8 | ) | (31,386 | ) | (0.8 | )
Total |  | 4,486,724 |  | 100.0 |  | 4,318,073 |  | 100.0 |  | 4,049,830 |  | 100.0 |

(1) Comparable revenues considering intersegment sales and the reclassification of the biological products for non-therapeutic use sales that are reported as Bio Supplies division sales from January 2017.

The Bioscience Division

The Bioscience division is responsible for the research and development, production and marketing of plasma derivative products. In 2018, the Bioscience division accounted for 78.4% of total net revenue.

Operational Structure

The following chart illustrates its operational structure:

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From plasma donation to therapeutic application, there are four major steps in the industry value chain process: (i) plasma collection, (ii) transport and logistics, (iii) manufacturing (fractionation and purification) and (iv) marketing and distribution. We are present at all levels of the value chain, from collection centers to distribution of the final products. This vertical integration enables us to leverage our position at each stage to control the overall process, to benefit from lower prices and to introduce complementary products, such as those offered through the Hospital division and the Diagnostic division, to our customers.

Plasma Collection

Plasma is the key raw material used in the production of plasma-derived products. We have expanded our plasma collection network through a combination of organic growth by opening new plasma collection centers and acquisitions. We obtain our plasma primarily from the United States through 197 operating plasma collection centers and, to a much lesser extent, through agreements with third parties. In 2018, we also obtained the rights to all plasma collected at an additional 24 plasma centers in the United States and 35 plasma centers in Germany. See Item 5 of this Part I, “Operating and Financial Review and Prospects - A. Operating Results - Factors Affecting Our Financial Condition and Results of Operations - Acquisitions - Acquisition and Sale of Haema AG and Biotest Corporation” below. In 2018, we obtained approximately 12 million liters of plasma (including specialty plasma required for the production of hyperimmunes and plasma acquired from third parties). We have previously announced that we plan to reach 325 approved plasma collection centers by 2023 globally.

We believe that our plasma requirements through 2019 will be met through plasma collected at our plasma collection centers and purchased from third-party suppliers pursuant to various plasma purchase agreements. As we source the majority of our plasma internally, we have been able to ensure the availability of plasma for our manufacturing needs, assure the quality of the plasma throughout our manufacturing process and improve control over our plasma costs and our margins.

We have implemented mechanisms to ensure that plasma donors meet the guidelines set forth by applicable regulations regarding, among other things, health, age and frequency of donations. Once the plasma donation is completed, as required by applicable United States and European regulations, we test every donation for pathogens such as HIV, hepatitis A, B and C, parvovirus B19 and syphilis. If we discover a unit of plasma that cannot be used in the fractionation process, we notify the donor and remove all plasma previously donated by such donor from our inventory.

Transport and Logistics

Once plasma has been collected, it is frozen at the collection center and sent to fractionation centers. One essential aspect of this process is the implementation of safety procedures to guarantee the quality and safety of the donated plasma. To ensure preservation of the proteins found in plasma, plasma must be kept at a temperature of -20 degrees Celsius (-4 degrees Fahrenheit). In accordance with European and United States requirements, we store our plasma at a temperature of -30 degrees Celsius (-22 degrees Fahrenheit). During transportation, plasma is kept at a temperature of at least -20 degrees Celsius. Our frozen plasma is transported by one of two transport companies, which are the same used throughout the industry.

Fractionation and Purification

Once plasma has been obtained, it may be used for plasma transfusions. It may also be frozen (as fresh frozen plasma) and manufactured into plasma derivatives through the fractionation process. The fractionation process consists of the separation of specific proteins through temperature and pH changes, as well as the use of filtration and centrifugation techniques. This process also includes a phase of introducing various viral inactivation procedures. Fractionation occurs in tanks at near freezing temperatures to maintain the integrity of the proteins. All known plasma derivative products can be fractionated from the same batch of plasma. As a result, the development of a new or higher yield plasma derivative product would likely generate incremental sales without increasing the requirement for additional plasma.

We currently operate three Bioscience manufacturing facilities in the United States and Spain. Our plasma derivative products are manufactured at our Clayton, Los Angeles and Parets facilities, which have a combined fractionation capacity of approximately 14.8 million liters per year. Our Clayton facility is one of the world’s largest integrated protein manufacturing sites, including fractionation, purification and aseptic filling and finishing of plasma-derived proteins.

Currently, the Clayton, Los Angeles and Parets facilities are equipped and licensed to produce certain plasma derivative products for the United States, European and other markets. For example, we produce our Flebogamma® DIF and Gamunex® IVIG products for all of our markets at the Clayton, Los Angeles and Parets facilities.

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We optimize utilization of our fractionation capacity by obtaining FDA and EMA licenses, and completing further requirements, that allow us to purify at any of our other facilities intermediate products that are produced at one of our facilities. We have obtained the following FDA licenses, among others:

· to purify at our Clayton facility the Fraction II+III (an intermediate product) made at both our Los Angeles and Parets facilities to make Gamunex®;

· to purify at our Los Angeles facility the Fraction II+III obtained at that facility to make Gamunex® 10%;

· to use Fraction V obtained at our Clayton facility to produce albumin at our Los Angeles facility;

· to use Fraction V obtained at our new fractionation facility at Clayton to produce Albutein® in our Los Angeles facility;

· to use Fraction IV-1 obtained at our Los Angeles facility to produce Prolastina®, an A1PI we market in Spain, at our Clayton facility;

· to use Fraction IV-1 obtained at our Clayton facility to produce Prolastin® at our Parets facility;

· to use Fraction IV-1 obtained at our Parets facility to produce Prolastin® at our Parets facility

· to use the same method currently in place in our Parets facility to produce Alphanate® in our Los Angeles facility;

· to use paste from the new fractionation facility at Clayton to produce Gamunex® and Prolastin®;

· to produce nano-filtered Gamunex® and the 40 gram vial presentation; and

· to use Cryoprecipitate obtained at our Clayton Facility to produce Alphanate® at our Los Angeles facility.

We are continuing our efforts to obtain additional FDA licenses of this nature. The flexibility provided through such licenses allows us to increase production efficiency and to better address changes in demand between the United States, the European Union and other world markets.

For more information on our manufacturing facilities, see “— D. Property, Plant and Equipment” below.

Safety

We have never experienced a recall of any batch of our finished biological products due to a safety risk, although in 2018 Grifols voluntarily withdrew three lots of product. The first case was due to an error in which the adverse consequences for patients were not included in the packaging components. The other two cases were due to a reported rate of adverse drug reactions higher than usual. Our philosophy is that the health of the plasma donor and the patient are the paramount considerations. We strongly believe that our safety philosophy is consistent with the business objective of generating profit. We also believe that we have a strong reputation for safety in our markets, thus making our products particularly attractive to customers. Our vertically integrated business model allows us to assure the safety and quality of our plasma derivative products through the implementation of our safety standards.

The plasma collection, fractionation and purification process is long, complex and highly regulated. We have adopted and maintain rigorous safety standards that we believe exceed those required by health authorities in Europe and the United States. Grifols is periodically inspected and certified for Good Manufacturing Practices (GMP) by competent health authorities, such as European authorities, the FDA, and other relevant government authorities of other countries where our products are marketed.

Grifols maintains standards consistent with other industry participants with regard to plasma safety, and is periodically certified by the Plasma Protein Therapeutics Association (PPTA) under the International Quality Plasma Program (IQPP) for plasma donation centers, and under the Quality Standards of Excellence, Assurance and Leadership Program (QSEAL) for fractionation plants. For example, source plasma inventory is held for not less than 60 days after donation, to allow for retrieval and destruction of plasma units if the donor is disqualified during this period (after seroconversion or due to high-risk behavior or international travel). We have also introduced innovative methods such as the Plasma Bottle Sampling™ system, which automatically prepares, codes and labels test samples at the time of plasma donation, and the PediGri™ On Line system, which provides full traceability of human plasma raw material throughout the plasma supply chain. See “— Distribution Process” below.

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The manufacturing plants have been designed fulfilling the current GMP standards and applicable regulations for clean areas, and are designed to minimize clean areas as well as human intervention, with the objective of lowering the risk of contamination. The facilities are subject to a cleaning and sanitizing plan and to a corrective and preventive maintenance program. Periodically, we voluntarily shut down all of our manufacturing facilities to perform maintenance work, expansion projects and other capital investments. Our manufacturing facilities have never been shut down because of regulatory noncompliance while under our operation. We believe that our voluntary shutdown procedure lowers the risk of any mandatory shutdown.

All of our plasma derived products are manufactured strictly following validated and approved procedures, and in accordance with the corresponding marketing authorization. Also, each manufacturing process includes at least one validated specific virus inactivation or removal step as a precautionary measure to avoid improbable virus contamination.

Since our products are proteins they cannot be terminally sterilized, and therefore are sterilized by filtration before being aseptically filled in their final container. Grifols has patented the Grifols Sterile Filling (GSF) system which minimizes the risk of microbial or particulate contamination during the aseptic filling process. During this process, sterilized containers are filled with the product under Grade A laminar air flow. The partially closed containers (vial with stopper and protector) are sterilized prior to filling. The container closure unit remains partially closed until the moment of filling, after which it is immediately sealed thus reducing the risk of contamination by reducing the product and container exposure to the controlled environment. The filling process is recorded which enables us to identify the cause of, and rectify more easily, any related problem. These records are maintained according to our data retention policy.

Once aseptically filled, each unit of product is laser-marked with the objective of individually identifying each container and preventing and detecting counterfeits. This allows us to protect the integrity of our manufacturing process.

After plasma derivatives are manufactured, every unit of each lot is visually inspected in order to detect the presence of foreign particles or other imperfections in the container closure system. Each lot is also tested during production and at the end of the manufacturing process according to the licensed specifications, marketing authorization and corresponding Pharmacopoeia monographs. All processes are overseen by the quality systems in place at Grifols with the objective of ensuring that products are marketed with the appropriate quality, purity, potency and safety.

Finally, once the product is marketed, our Pharmacovigilance system allows us to control all potential adverse reactions resulting from the administration of our products, thus ensuring the safety of our products globally around the world.

We continually invest in the improvement of our manufacturing facilities and plasma fractionation process, as well as in other related systems, in order to ensure the quality and safety of our products.

Distribution Process

With each batch of plasma derivatives, we deliver electronic information regarding the origin, characteristics and controls of each of the units of plasma that we used in the preparation of the batch to our customers. This feature, called the PediGri™ On Line system, allows for healthcare users of our products and regulatory authorities to have immediate and easy access to this information, tangible proof of the full traceability of our products. We have had this system in place since 1996, and we believe we are the only fractionator that provides this feature to customers.

We have our own sales and distribution networks covering substantially all of our markets, staffed with highly trained personnel. A majority of our sales in 2018 were made through our own distribution network, which is experienced in the proper handling of our products. This network provides for greater safety because it allows us to track our products and react quickly in the case of a potential product recall. In countries where we do not have our own distribution network, we use carefully selected distributors who follow all of our safety standards.

For further information, see “— Marketing and Distribution” below.

Bioscience Products and Services

Collected plasma, whether source or recovered, is fractionated into different component proteins. We fractionate and purify a broad range of plasma derivative products that improve patient care.

Our principal plasma derivative products are IVIG, A1PI, Factor VIII and albumin, each sold under various brand names, and their respective applications are as follows:

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Product Description |  | Main Applications
Gamunex®/Gamunex®-C. Immune Globulin Injection (Human), 10% Caprylate/Chomatography Purified. |  | IVIG is used for the treatment of: primary and secondary immunological deficiencies; and autoimmune conditions including immune-mediated ITP; Guillain Barré syndrome; Kawasaki disease; allogenic bone marrow transplants; and chronic inflammatory demyelinating polyneuropathy (CIDP) (Gamunex®/Gamunex®-C only).
Flebogamma® 5% and 10% DIF. Immune Globulin Intravenous (Human). |  | IVIG is used for the treatment of: primary and secondary immunological deficiencies; and autoimmune conditions including immune-mediated ITP; Guillain Barré syndrome;
Flebogamma® 5%. Immune Globulin Intravenous (Human). |  | Kawasaki disease; allogenic bone marrow transplants; and chronic inflammatory demyelinating polyneuropathy (CIDP) (Gamunex®/Gamunex®-C only).
HyperRAB® |  | Anti-rabies immunoglobulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies who have not been previously vaccinated with rabies vaccine.
Prolastin®/Prolastin®-C/ Prolastin®-C Liquid/Prolastina®/Pulmolast®. Alpha 1-Proteinase Inhibitor (Human). |  | Used to treat adults with clinical evidence of emphysema due to severe hereditary A1PI deficiency (alpha-1 antitrypsin deficiency).
Fanhdi™ and Alphanate®. Antihemophilic Factor/von Willebrand Factor Complex (Human). |  | Used for the prevention and control of bleeding in Factor VIII deficiency (hemophilia A) and indication for von Willebrand disease (in the United States, for Alphanate® only).
Koate®-DVI. Antihemophilic Factor (Human). |  | Used for the prevention and control of bleeding in Factor VIII deficiency (hemophilia A).
Albutein®/ Human Albumin Grifols®/Plasbumin®. Albumin (Human) 5%, 20% and 25%. |  | Used to re-establish and maintain circulation volume in the treatment of hypovolemia (i.e., traumatic or hemorrhagic shock and severe burns) and to treat complications related to cirrhosis.

Our acquisition of Talecris expanded our portfolio of IVIG, A1PI, Factor VIII, albumin, and other plasma derivative products.

Gamunex® IVIG, which was launched in the United States and Canada in 2003 as a ready-to-use liquid IVIG product, is one of the leading products in the IVIG segment. We believe Gamunex® IVIG is one of the premium products in its category since its launch due to a comprehensive set of differentiated product characteristics. We believe we had an estimated 30% market share in the United States for IVIG as of November 2018.

HyperRAB® is the world’s leading human anti-rabies immunoglobulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies who have not been previously vaccinated with rabies vaccine. A 300 IU/ml formulation of HyperRAB® is now available in the U.S. (FDA approval February 2018). HyperRAB® only human rabies immunoglobulin (HRIG) has a higher-potency formulation, offering potentially fewer injections in administration of each dose. Grifols has an estimated 90% market share of anti-rabies immunoglobulins in the United States as of December 2018.

In addition, we are the world’s largest producer of A1PI, an augmentation therapy of emphysema related to severe hereditary A1PI deficiency. It is licensed in 29 countries worldwide. Prolastin®/ Prolastin®-C is the leading A1PI product in the United States and Europe, where it is licensed in 15 countries. In Italy and Spain, we previously distributed Prolastin® using third parties. We began direct distribution of Prolastin® in those two countries in 2013, and began conducting clinical trials in Europe in 2013 to obtain Prolastin®-C approval there.

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We had an estimated 67% global market share for A1PI at the end of 2018. In September 2017, the FDA approved our liquid formulation of A1PI (Prolastin®-C Liquid) as a chronic augmentation and maintenance therapy to treat emphysema related to severe hereditary A1PI deficiency.

Koate®-DVI was first approved in the U.S. in 1999 for hemophilia A treatment. Together with Fanhdi and Alphanate, Grifols had an estimated 20% market share globally in the FVIII hemophilia A market in 2017 (excluding Von Willebrand disease use). Grifols albumin brands are sold globally, with an 18% market share. In addition, our albumin products meet U.S. and European requirements, making them attractive to biotechnology companies and genetic labs, as well as hospitals and physicians.

In addition to the products described above, we also produce intramuscular (hyperimmune) immunoglobulins, which are used for the prevention and treatment of tetanus, prevention and treatment of hepatitis B, and Rh factor complications during birth; Anbinex® and Thrombate® III, which are used in the prevention and treatment of thromboembolic complications in patients with antithrombin deficiency; AlphaNine® and Factor IX Grifols®, which are used in the prevention and control of bleeding in patients with hemophilia B; and Niuliva® and Igantibe®, which are used after liver transplants to prevent hepatitis B reinfection of the graft. In 2017, we obtained FDA and EMA approval for a biological sealant composed of fibrinogen and human thrombin used in surgical operations to expedite the healing process.

To sell plasma derivative products, we must first register the products with the relevant authorities of the jurisdictions where the products are to be marketed and sold. To comply with the regulatory requirements in a given jurisdiction, we have a core team in Spain and the United States that prepares, files and coordinates the registration process with the technical personnel at the subsidiary assigned to that jurisdiction. We have 694 hemoderivative product licenses registered in 93 countries throughout Europe, the United States, Latin America, Asia and the rest of the world. Our most significant government-issued licenses for plasma derivative products are:

· Gamunex®/Gamunex®-C/Flebogamma® DIF/Flebogamma® Immunoglobulin. We have 111 licenses for the marketing and sale of one or more of these immunoglobulin products;

· Fanhdi™/Alphanate®/Koate®- DVI Factor VIII. We have 99 licenses for the marketing and sale of one or more of these Factor VIII products;

· Albutein®/Human Albumin Grifols ®/Plasbumin®. We have 201 licenses for the marketing and sale of one or more of these albumin products in its various concentrations; and

· Prolastin®/Trypsone® A1PI. We have 35 licenses for the marketing and sale of one or both of these A1PI products.

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Pursuant to the Consent Order, we have granted Kedrion the exclusive license to sell Koate®-DVI in the United States (as defined in Item 8 of this Part I, “Financial Information — A. Consolidated Statements and Other Financial Information — Antitrust Approval of Talecris-Grifols Merger”).

In addition to the sale of the products described above, we have entered into a series of arrangements with many Spanish transfusion organizations to fractionate recovered plasma (plasma separated from blood obtained from a blood donation) from such organizations and manufacture plasma derivatives under our own brand name for use by hospitals. We charge the transfusion centers for the fractionation and manufacturing service. We also have contract manufacturing agreements with Italian, Czech and Slovak organizations. We also provide virus photo-inactivation of transfusion plasma to hospitals and clinics in Spain. The plasma is inactivated at our manufacturing facilities and then sent back to the clinic or hospital at which it was collected, where it is used for transfusions.

The Diagnostic Division

The Diagnostic division focuses on researching, developing, manufacturing and marketing in vitro diagnostics products, including analytical instruments, reagents, software and associated products for use in diagnostic clinical and blood bank laboratories. We believe that we have a significant market share of sales in NAT blood screening solutions. In addition, we have increased our sales of automated immunohematology systems and reagents to hospital transfusion and blood centers in several markets. We also continue to grow our portfolio of clinical and diagnostic products in select areas, including autoimmunity and hemostasis, and have agreements to extend the number of antigens we manufacture for use in clinical and blood bank diagnostic tests. The Diagnostic division accounted for €702.3 million, or 15.6% of total net revenue in 2018. Our principal diagnostic products are:

Product Description |  | Main Applications
Transfusion Medicine: |  |
Procleix® Tigris®/Procleix® Panther® systems. Automated NAT blood screening systems, assays and software. |  | Used to detect infectious viruses in donated blood and plasma including: HIV (Types 1 & 2); Hepatitis A, Hepatitis B, Hepatitis C and Hepatitis E; parvovirus B19; West Nile Virus; Dengue Virus; Zika and Babesia.
WADiana®/Erytra® /Erytra® Eflexys analyzers. Automated immunohematology analyzers that use gel agglutination technology to enable automatic processing of DG Gel® blood determination cards. |  | Used to perform routine pre-transfusion blood typing, antibody screening, antibody identification and cross-match tests.
Antigens. Critical component of certain infectious disease tests. |  | Used in the manufacture of clinical diagnostic and blood donor screening immunoassays.
Leucored and standard blood bags. Blood bags configured according to all blood bank separation protocols. Leucored blood bags incorporate an in-line filtration system. |  | Used for collection and transfusion of blood.
Clinical and Specialty Diagnostics: |  |
Triturus® analyzers. Open and fully automated analyzer for ELISA (enzyme-linked immunoabsorbent assay), tests with multi-test/multi-batch capability. |  | Automates the enzyme immunoassay testing in microtiter plate format and the processing of several batches of samples simultaneously.
Q-Smart™, Q-Next™, and Q-Expert™ analyzers. Fully automated hemostasis analyzers that use reagents to measure blood coagulation levels. |  | Used to diagnose and measure blood coagulation status of patients with blood coagulation-related and hemorrhagic disorders.
Coagulation reagents, instrumentation and software. |  | Used to establish the coagulation status of patients and to handle the corresponding results.
Promonitor. Highly specific ELISA kits for quantification of serum drug levels and anti-drug antibodies of various biological drugs |  | Used to measure quantity of drug and antibodies for a number of biological drugs, commonly used in the treatment of various inflammatory diseases.

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We assemble the majority of our instrument analyzers at our Parets facility. We manufacture antigens at our Emeryville facility, oligos and other critical components of the transcription-mediated amplified NAT kits for blood and plasma infectious diseases screening at our San Diego facility and our blood bags at our facility located in Las Torres de Cotillas, Murcia, Spain, or the Murcia facility, which has an estimated capacity of nine million blood bags per year.

The production, marketing and sale of many of our Diagnostic division products are subject to the prior registration of such products with the relevant authorities of the applicable jurisdictions. We have over 2,496 diagnostic product licenses registered in 70 countries in Europe, the United States, Canada, Latin America, Africa and Asia.

In addition to the products noted above, we offer our customers products developed in collaboration with, or manufactured by, third-parties that we believe complement our product lines.

The Diagnostic division distributes products in Europe, North America, Asia-Pacific, the Middle East, Latin America and Africa.

In January 2014, we acquired from Novartis a complete line of products and systems to perform blood donor screening molecular tests aimed at detecting the pathogenic agents of transfusion-related infectious diseases such as HIV, hepatitis B, hepatitis C and West Nile Virus. The Novartis Diagnostic Business has been integrated in our current Diagnostic division, resulting in a significant expansion of our transfusion medicine product portfolio. More recently, in January 2017, we completed the Hologic Transaction. Prior to the Hologic Transaction, we and Hologic jointly operated this business, with Hologic responsible for research and development and manufacturing of the Procleix® blood screening products and Grifols responsible for their commercialization worldwide. Following the acquisition, we now control the research and development processes as well as the manufacturing of the reagents. We believe the Procleix® NAT solutions that we added to our portfolio in the Hologic Transaction, which we were already commercializing following the Novartis Acquisition, continue to lead the market, and are used to screen more blood and plasma donations worldwide each year than any other NAT system. The Procleix® products are designed to directly detect the genetic material of a virus using a technique called transcription-mediated amplification (TMA).

Transfusion Medicine

Grifols has a leadership position in transfusion medicine, with a broad portfolio of products that range from blood collection, blood and plasma testing to blood typing and transfusion. Our growth strategy in transfusion medicine has been strengthened by the January 2014 acquisition of the transfusion medicine and immunology diagnostic unit of Novartis and the recent Hologic Transaction. We focus primarily on meeting changing market needs with new and enhanced products for our Procleix NAT blood screening portfolio and on expanding sales of our immunohematology products in key markets (WADiana®, Erytra® and Erytra-Eflexis® analyzers and related DG Gel® blood determination cards).

We continue to focus on obtaining FDA and other regulatory approvals to expand our portfolio of NAT products. In 2015, a European Conformity, or CE mark, was granted for the NAT test that detects both parvovirus B19 and hepatitis A virus (Procleix® Parvo/HAV) in human plasma on the Procleix® Panther platform, enabling Grifols to increase the number of tests available for this platform and to expand its portfolio of products designed to meet the specific needs of the plasma industry. In 2016, the Procleix® Tigris system underwent a series of significant software and hardware improvements to better address evolving market needs, including more functional and streamlined software and increased storage holding for key consumables.

Clinical trials to support U.S. registration of the Procleix Ultrio Elite Assay (HIV and hepatitis B and C) and Procleix WNV Assay (West Nile Virus) on the Procleix Panther system were completed in 2016 and the corresponding Biologics License Applications (BLA) were subsequently submitted for review to the FDA. The BLA approval for both assays and the Procleix Panther system was received during the second quarter of 2018. A new version of the Procleix® Xpress (v.3.0) pipette was submitted for FDA approval during 2017 and approved during the first quarter of 2018.

In 2016, we began working on an Investigational Use Only (IUO) assay to accommodate requests to test blood in areas potentially affected by the Zika virus. In June 2016, the first samples were tested using Grifols Procleix® Zika virus assay on a Procleix® Panther® system under an Investigational new drug (IND) protocol. In August 2016, the FDA issued non-binding recommendations that require NAT screening of all individual donations in the United States and its territories. Grifols is currently providing reagents, instruments and services to all of our U.S. customers to allow the screening of more than 85% of the U.S. blood supply. The record-time development of the Procleix Zika virus assay, reinforces our commitment to blood safety worldwide. In 2017, we obtained CE marking for the Zika virus assay. In July 2018, the assay obtained FDA approval. Shortly after that, the FDA issued guidance mandating testing of all blood in the U.S. for Zika virus and allowing for pool testing.

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In 2017, a new assay to detect babesia, a tick borne disease, obtained FDA approval under an Investigational New Drug protocol. The assay is designed to be used for routine screening by U.S. blood banks on the Procleix® Panther® system. The assay was subsequently submitted for review to the FDA, and it was finally approved in February 2019.

As part of our strategy of geographic expansion and as a leader in this market segment, we continue to consider requests to include NAT screening for blood and plasma donations in countries as they develop their health systems. In this regard, it is important to highlight several new contracts in the Middle East. In 2015, we won a tender in Saudi Arabia to supply the Saudi Arabian National Guard, followed by a contract in 2016 to supply transfusion services to the Saudi Ministry of Health (MoH) and the majority of the member countries of the Cooperation Council for the Arab States of the Gulf (CCASG), establishing Grifols as the leading provider of NAT technology in the region. During 2016, we conducted our first sales in Oman and Kuwait. We opened a new training center in Dubai in 2016 to further support our growth in the region. The center offers single and multi-day training courses for laboratory technicians, engineers and specialists in Grifols’ broad portfolio of products in transfusion medicine and clinical diagnostic.

We continue to experience strong sales of our DG Gel® blood typing products. In December 2016, we obtained CE marking for Erytra Eflexis®, a fully automated, mid-size analyzer that performs pretransfusion compatibility testing using DG Gel® technology that was launched in June 2017. The instrument was later approved by the FDA in December 2018. It has a smart and compact design, offering intuitive operation that has expanded our product portfolio, which already includes the WADiana® and Erytra® analyzers and DG Gel® cards. In the United States, our blood typing solutions have experienced solid growth. Grifols has expanded commercialization efforts and will continue to promote this area in light of its high growth potential.

In 2015, we opened the “Grifols Immunohematology Center” in our laboratories in San Marcos, Texas. The Grifols Immunohematology Center provides reference lab testing, consulting and education services to transfusion medicine professionals. In 2016, we expanded the number of tests offered by the center to include simple and complex serological tests.

In several countries, we distribute the BLOODchip® blood group genotyping tests manufactured by Progenika, a Grifols company. In 2017, Progenika obtained CE marking for the ID RHD XT Diagnostic Kit, a new molecular diagnostic kit that detects the most relevant RhD variations, and obtained FDA approval for a new genetic test to detect alpha-1 antitrypsin deficiency. This test has had CE mark approval since December 2016 and received FDA approval in October 2018.

In select markets, we are working to expand the availability of Grifols’ blood collection bags and systems, as well as our Gricode™ transfusion component tracing systems. To strengthen our position in Brazil, we finished construction of a blood bag manufacturing plant in Campo Largo (Paraná) in November 2017, where we commenced operations in 2018. The plant has an initial production capacity of two million units, expandable to four million units.

As part of the Novartis Acquisition, we also acquired a product line of high quality antigens, which are critical components of clinical diagnostic and blood screening immunoassay tests sold worldwide, which are produced through a joint business with Ortho Clinical Diagnostic.

As part of this joint business with Ortho Clinical Diagnostic, in 2015, Grifols signed a new contract with Abbott Laboratories for the supply of high quality antigens used in the manufacture of immunoassay diagnostics. This contract, with a total value of approximately $700 million, extended the supply of antigens until 2026, ensuring higher levels of recurring income in this area. In 2017, we extended our existing agreement with OraSure Technologies by five years, reinforcing our position as a flexible provider of antigens. In 2016, we obtained CE mark approval for the VITROS® HIV Combo test, developed by Grifols and Ortho Clinical Diagnostics for the early detection of HIV infection. This is an important milestone in the joint business between the two companies, in which Grifols is responsible for manufacturing the antigens for the test. The test received approval from the FDA in October 2018 to be used on Ortho’s VITROS® ECi/EciQ. The test was previously approved for use on Ortho’s VITROS® 5600 Integrated System and Ortho’s VITROS® 3600 Immunodiagnostic System.

Clinical and Specialty Diagnostics

Our Q-Smart™, Q-Next™, Q-Expert™ and Triturus® analyzers remain key product lines in the clinical and specialty diagnostics product line. In 2015, the Q-Smart™ analyzer (a mechanism for laboratories to automate and standardize hemostasis tests) was commercially launched in Latin America. The FDA is currently evaluating several products in our hemostasis line in 2018, including different Q product line analyzers. In 2017, we strengthened our hemostasis line with an agreement with Beckman Coulter, a global supplier of diagnostic solutions. The exclusive, long-term agreement includes the worldwide distribution of our hemostasis instruments, reagents and consumables.

We also continue to offer a broad portfolio of hemostasis reagents in this line, including DG™-Chrom PC, a proprietary chromogenic kit for Protein C, and DG™-TT L human reagent, a liquid human thrombin for determining thrombin time.

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Also within Clinical and Specialty Diagnostics, Progenika Biopharma obtained in 2015 CE marking for its first genetic diagnosis test for Familial Hypercholesterolemia (FH) using next generation sequencing technology (NGS). The division continues its efforts to broaden the Promonitor® line, used to monitor biologic drugs as sales continue in Chile, select European Union countries and Australia. The Promonitor® product line includes an ELISA (enzyme-linked immunoabsorbent assay) device line also developed by Progenika to monitor patients being treated with biological medicines for rheumatoid arthritis and other chronic inflammatory diseases. In 2015, CE marking was granted for two new references of tests in the Promonitor family that enable treatment with the biological product golimumab. In 2016, we obtained CE marking for several new reference tests in the Promonitor family of products, to permit the use of a single dilution to measure quantity of drug and antibodies for a number of biological drugs, commonly used in the treatment of various inflammatory diseases, such as rheumatoid arthritis and ulcerative colitis. In 2017 the division launched the PromonitorQuick®, a point-of-care diagnostic kit that detects anti-infliximab antibodies, antibodies that appear in patients with chronic inflammatory diseases who are treated with biological drugs.

We also continue to distribute our Triturus® analyzer, an open and fully automated analyzer for ELISA tests with multi-test/multi-batch capability. As an open system, it can be used for the automatization of our autoimmunity and biological drug monitoring product lines and other products in our portfolio for which we are distributors.

In 2015, we signed an exclusive agreement for distribution of AESKU Diagnostics GmbH & Co.’s autoimmunity diagnostic products in the United States and Mexico. We also have various distribution agreements with AESKU in Chile, Italy, Portugal, Spain and the United Kingdom. In 2016, AESKU obtained FDA approval for Helios, the only fully automated platform capable of performing all immunofluorescence pipetting and reading steps in the United States, which strengthened our portfolio of products in the country. During 2018, AESKU obtained FDA approval of two additional assays for Helios, Antineutropil cytoplasmatic antibodies and nuclear Deoxyribonucleic acid. These products further strengthen the portfolio of IFA products offered in the U.S.

We continue to sell the Intercept Blood System®, developed by Cerus, to inactivate pathogens in blood platelets and plasma in Spain and Mexico.

The Hospital Division

The Hospital division provides services and manufactures products used by hospitals, blood banks, plasma collection centers and other healthcare systems. These products include parenteral solutions, robotics and software. It also includes products that we do not manufacture but that we market as supplementary to the products that we do manufacture. The Hospital division accounted for €119.5 million, or 2.7%, of our total net revenue in 2018.

Hospital logistics and i.v. tools segments are also strategic areas for the Hospital division. With i.v. tools, we are the leaders in bringing GMP procedures and product solutions to the hospital pharmacy, increasing the safety of their compounding needs. With the hardware and software solutions offered by the Hospital logistics area, we are the market leader in Spain and Latin America in terms of offering solutions to manage the flow of medications in hospitals. At the beginning of 2018, Grifols reinforced the division by acquiring the U.S. technology firm MedKeeper, which develops and markets mobile and web-based technology solutions for the management of hospital pharmacies. See Item 5 of this Part I, “Operating and Financial Review and Prospects - A. Operating Results - Factors Affecting Our Financial Condition and Results of Operations - Acquisitions - MedKeeper Investment” below. The acquisition complements our Pharmatech line and enhances our presence in the U.S. market.

IV Therapy is also a key segment of the division where we manufacture and distribute directly or through third parties products such as parenteral solutions and enteral nutritional products, which are mainly sold in Spain and Portugal. We believe we are the leader in the Spanish intravenous therapy segment in intravenous solutions, with a 31% market share according to our internal records, and in 2018 Grifols’ 0.9% Sodium Chloride was marketed in the U.S. for the first time following the FDA approval of all volume bags in 2017 and 2018. The following table describes the principal hospital products that we manufacture, distribute or install and their respective applications:

Product Description |  | Main Applications
Intravenous therapy: |  |
Intravenous fluid and electrolyte solutions. Main product groups include hypotonic solutions, isotonic solutions, hypertonic solutions and plasma volume expander solutions. |  | Fluid and electrolyte replacement and conduit for the administration of medicines.
Irrigation solutions. |  | Fluids for urological irrigation.
Intravenous mixtures. Ready-to-use intravenous mixtures of potassium, antibiotics and paracetamol. |  | Increases safety and efficiency by rendering unnecessary the mixing of solutions at in-hospital pharmacies.

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Product Description |  | Main Applications
Pharmatech: |  |
i.v. Tools. Gri-fill® System uses sterile filtration to prepare intravenous mixtures at in-hospital pharmacies. Misterium® are modular clean room facilities we sell in the United States and IBAM. The Kiro Oncology automation system is designed specifically for the preparation of cytotoxic drugs. PharmacyKeeper is a web and mobile-based application to improve key pharmacy operational processes. |  | Improves safety of hospital pharmacy preparation procedures by assuring sterility, traceability, user safety and quality to ensure compliance with regulations.
Hospital Logistics. Includes products such as: packaging instruments; software programs, including our own BlisPack®; and logistic dispensing systems, including Pyxis®, StocKey® and StocKey® RFID Smart Cabinet, and Kardex®, for inventory control. |  | Used in the logistical organization of hospital pharmacies and warehouses, in the preparation of unit dosing and in hospital management, admissions and accounting.
Nutrition: |  |
Dietgrif® enteral liquid diets. Oral diets with all the requirements for balanced nutrition. Different diets include standard, standard fiber, polypeptidic, hyperproteic and energetic. |  | For patients who are unable to eat enough to maintain a nutritious diet, administered through feeding tubes as well as orally.
Probiotics. Special complementary diets composed of live microorganisms. |  | Improves gastroenterology conditions that are the result of a lack of intestinal microflora.
Medical Devices: Disposable sterile therapeutic medical products. |  | The products have therapeutics uses in urology, radiology, cardiology, neurology hemodynamics and anesthesia.

The production, marketing or sale of our various Hospital division products are subject to prior registration with authorities of the relevant jurisdictions. We have approximately 186 licenses for our Hospital division products registered in 40 countries throughout Europe, Latin America, Africa, Canada and the United States. Our sales representatives sell primarily to pharmacy, nutrition and gastroenterology units in hospitals and other units in hospitals that use our medical devices, using our own distribution network and external distribution organizations in some Latin American markets.

While our Hospital division generates most of its revenue in Spain (59% of net revenue in 2018), we continue to promote international expansion. In 2017, the FDA approved Grifols’ 500 ml normal saline solution in polypropylene bags (0.9% sodium chloride) and in 2018 the FDA approved the 50 ml, 100 ml, 250 ml and 1,000 ml candidates. These important milestones reinforced the global expansion of the division and mark an important step forward.

The Hospital division has established a new commercial strategy to promote Pharmatech’s presence in Latin America through the use of specialist distributors in this sector, while also maintaining a direct sales effort.

Intravenous Therapy

We manufacture and distribute intravenous solutions, primarily in Spain. In 2017, the FDA approved Grifols’ 500 ml normal saline solution in polypropylene bags (0.9% sodium chloride), manufactured in our Murcia (Spain) plant, allowing the division to market this product in the U.S. market. The FDA approval also increases the group’s self-sufficiency, and the product will also be used in Grifols’ U.S. plasma collection centers to restore the circulatory volume in donors. The FDA approval reinforces the division’s global expansion and marks an important step forward that opens up the possibility of new future authorizations for other products manufactured in the Murcia and Barcelona facilities. Moreover, it bolsters Grifols’ global expansion efforts and confirms its strategy of fostering the complement of products and services among its divisions. In addition, we have increased our focus on manufacturing ready-to-use intravenous mixtures for third parties. We believe this approach will contribute to the Hospital division’s geographic diversification and allow us to maximize productive use of the Parets facility.

Intravenous paracetamol for Latin America is in the regulatory approval process in Mexico, Colombia and Argentina and approvals are expected shortly, while the product has already been launched in Chile. Intravenous ibuprofen under the Grifols brand is also in the regulatory approval phase in all Iberoamerican countries and Europe while the product has begun to be marketed in the

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U.S. We have signed agreements with each of Henry Schein and Hemasource for 0.9% Sodium Chloride distribution in the United States.

We continue to consolidate third-party manufacturing contracts. In 2018, the Hospital division completed new developments such as the Intercept® Red Blood Cells System, a combination product that includes three blood bags, one filter set plus two inactivation drugs to perform the process of inactivating red blood cells, and milrinone IV ready-to-use flexible bags, both of which have been submitted to regulatory authorities for approval. FDA approval has been obtained for Tirofiban IV (prediluted platelets) and Ibuprofen IV, both ready-to-use in flexible bag products.

Pharmatech: Hospital Logistics and i.v. Tools

We provide logistic solutions to hospital pharmacies by selling products related to the logistical organization of pharmacies and warehouses of hospitals, including packaging instruments and software programs for hospital management, admissions and accounting departments. Most of these Hospital Logistics products are manufactured by third parties. However, our portfolio includes some products manufactured by Grifols such as StocKey®, an automated Kanban system designed to optimize hospitals’ healthcare material restocking processes, StocKey RFID®, a radiofrequency identification cabinet for the storage of high value medical devices, such as prosthetics and coronary stents, and BlisPack®, a system designed and manufactured by us to automate the cutting of prescription pill blister packs and the electronic identification of specific drugs for individual patients to be used by hospitals.

We also manufacture and distribute a complete portfolio of tools used in connection with the preparation of specific intravenous medication, which we refer to as i.v. Tools. We commercialize Misterium®, a cleanroom we designed to order and install on site to customer specifications. We have expanded our Misterium® cleanroom solutions with the incorporation of airinspace®, a medically effective air and surface decontamination system. As the exclusive distributor of these products in the United States, Grifols is able to offer a broad portfolio of products for U.S. hospital pharmacies and pharmacies specialized in master formulas.

We are managing the global introduction of the Kiro Oncology robot, which automates the preparation of intravenous medication for chemotherapy to reduce the risk that health professionals will come into contact with these hazardous products. We expect that the Kiro Oncology robot will be one of the principal drivers of i.v. Tools product line growth in the near future. This system enables us to offer to hospital pharmacies worldwide what we believe to be the most complete portfolio of solutions for controlling intravenous medication preparation processes. In 2015, Kiro Grifols obtained FDA marketing approval for the Kiro Oncology system and in 2016 it was launched in the United States. In 2018 market penetration continued in Europe as well, with new consumers based in Spain, Sweden, Netherlands and Latvia.

With the acquisition of MedKeeper in January 2018, the i.v. tools portfolio has continued to develop. MedKeeper, with a SaaS business model, adds the missing piece of a compounding portfolio that enables the division to offer a holistic and integrated technology, software and service solution to our customers. See Item 5 of this Part I, “Operating and Financial Review and Prospects - A. Operating Results - Factors Affecting Our Financial Condition and Results of Operations - Acquisitions - MedKeeper Investment” below.

Nutrition

We develop and distribute enteral nutrition products, including accessories such as feeding tubes and nutritional bags, for sale in the Spanish market. The main driver of the segment is the distribution of gastric probes manufactured by Halyard Health, continuing our leadership in Spain with this product line.

Medical Devices

We also sell other medical devices, such as disposable sterile therapeutic medical products for urology, radiology, hemodynamics and anesthesia. All of these products are manufactured by third parties and complement our portfolio of Hospital division products. We are increasing our strategic efforts to sell medical devices that complement our portfolio of Bioscience division products. The main driver of growth in this segment in 2018 has been Neuroradiology disposables.

Research and Development

Research and development is a significant aspect of our business. Our principal research and development objectives are (i) to discover and develop new products, (ii) to research new applications for existing products and (iii) the improvement of our manufacturing processes to improve yields, safety and efficiency. Research and development spending moved from €288.3 million in 2017 to €240.6 million in 2018. Recurring research and development spending, excluding the specific impairment of Aradigm’s assets, was €223.7 million in 2017. See Note 11 to our audited consolidated financial statements included in this annual report on Form 20-F for more detail. In addition, as of December 31, 2018, we had 985 scientists and support staff dedicated to research and development.

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We have over 70 years of successful innovation history. For example, we developed a unique fractionation design that reduces the risk of contamination, reduces maintenance costs and increases the amount of product extracted per liter of plasma. We also developed the first centrifugation unit for the automated cleaning of blood cells. In addition, we were one of the first fractionators to conduct double viral inactivation processes for Factor VIII and have designed and implemented a new process for the sterile filling of vials that reduces exposure to potential contaminants as compared to other existing processes. Further, we have developed a nanofiltration method of viral inactivation for our IVIG, Alpha-1 PI, and ATIII products. As a result of our continuing investment in research and development, we believe that we are well positioned to continue as a leader in the plasma-derived therapies industry.

Bioscience Division Initiatives

The Talecris acquisition complemented our substantial Bioscience division research and development project portfolio.

We have a number of patents and research and development projects in our Bioscience division underway, 28 of which are in the clinical development phase. The following table reflects the total number of research and development projects in our Bioscience division by development phase as of the end of the last three years.

|  | As of December 31, |
Development Phase |  | 2018 |  | 2017 |  | 2016 |
Discovery |  | 12 |  | 14 |  | 16 |
Preclinical |  | 12 |  | 12 |  | 14 |
Clinical |  | 28 |  | 26 |  | 27 |
Post Commercialization Studies |  | 9 |  | 10 |  | 9 |
Rest of projects |  | 16 |  | 18 |  | 20 |
Total Bioscience Research and Development Projects |  | 77 |  | 80 |  | 86 |

The table below presents the most important of our research and development projects:

Product Candidate |  | Therapeutic Area |  | Product Type |  | Potential Use |  | Development Phase
Albumin and IVIG |  | Alzheimer’s |  | Plasma-derived |  | Alzheimer’s disease |  | Phase III (completed in first quarter of 2018)
Antithrombin |  | Intensive Care |  | Plasma-derived |  | Cardiovascular surgery |  | Phase II for Anbinex® (completed in June 2011) Phase II for Thrombate® III (completed in first quarter of 2018)
Fibrin glue |  | Surgical bleeding |  | Plasma-derived |  | Vascular, organ and soft-tissue surgery |  | Licensure (November 2017)

AMBAR Study. The Alzheimer Management by Albumin Replacement, or AMBAR, study was a multicenter trial that complemented two previous trials and involved combining therapeutic plasmapheresis with albumin and IVIG in different intervals and in varying doses. Since the AMBAR project was mainly based on albumin, the study also included a treatment arm with albumin alone in order for both approaches, the combination of albumin plus IVIG, and albumin alone, to be covered. Therefore, we conducted a Phase III clinical trial to demonstrate the efficacy of plasmapheresis with Albutein ® and Flebogamma ® DIF, for improving the cognitive status of patients with Alzheimer’s disease. The study was conducted in collaboration with hospitals in Spain and in the United States. We received approval for our study from both the Spanish Agency for Medicine and Health Products (Agencia Española del Medicamento y Productos Sanitarios) and the FDA, and 496 patients enrolled. In 2018, we completed the trial and presented AMBAR top line results, which demonstrated a statistically significant reduction of 61% in disease progression in both primary efficacy endpoints measuring cognition and activities of daily living during a 14-month period. The combination of plasmapheresis (a well-known and safe procedure used in plasma exchange) with Albutein® (albumin, a safe, well tolerated plasma protein with multiple properties) has demonstrated a significant reduction in the progression of the disease in the moderate Alzheimer’s disease patients participating in the study and may offer a new treatment pathway for the illness.

We incurred costs in the amount of €5.1 million, €10.1 million and €11.4 million in connection with this project in 2018, 2017 and 2016, respectively. We hold significant granted patents and patent applications on the production of albumin and IVIG as well as on the combination of plasma exchange with albumin replacement for the treatment of Alzheimer’s disease.

Antithrombin. In 2008, we initiated research into the clinical efficacy of antithrombin for use on cardiac surgery patients with cardiopulmonary bypass. In June 2011, we concluded Phase II clinical trials involving the use of our antithrombin Anbinex. In June 2014, we began a second Phase II trial for the same indication using Thrombate III. Enrollment was completed in January 2018.

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We incurred costs in the amount of €2.4 million, €4.2 million and €3.8 million in connection with this project in 2018, 2017 and 2016 respectively.

Fibrin Glue. We began clinical trials into the safety and efficacy of the use of fibrin glue as a supportive treatment for the improvement of hemostasis in vascular, organ and soft-tissue surgery in 2008. In 2014, we completed a clinical trial in the European Union for the use of fibrin glue in vascular surgery. Three additional clinical trials were performed: (i) a Phase III clinical trial in the United States for the use of fibrin glue in solid organ surgery; (ii) a Phase III clinical trial in the United States for the use of fibrin glue in soft-tissue surgery; and (iii) a Phase III clinical trial for the use of fibrin glue in vascular surgery in the United States. All of the U.S. clinical trials for fibrin glue were completed in 2015. Marketing authorization approvals were received from the FDA and EMA in November 2017.

We incurred costs in the amount of €1.1 million, €2.2 million and €7.8 million in connection with this project in 2018, 2017 and 2016, respectively. We hold significant granted patents on the fibrinogen and thrombin production processes.

Other Bioscience research and development projects undertaken during 2018 included:

· development of a high concentration immunoglobulin for subcutaneous administration;

· development of Immunoglobulin M for the treatment of bacteremia, fungemia, and other potential clinical indications;

· clinical programs to evaluate new indications of Flebogamma® DIF 5% and Gamunex®-C;

· A1PI. New vial sizes and concentrations of the liquid formulation of Prolastin®- C are in development and are expected to provide important advancements in manufacturing efficiency as well as improved patient convenience;

· clinical studies to evaluate the effects of the prolonged administration of human albumin on cardiovascular, hepatic and renal function in patients with advanced cirrhosis and ascites. One study involves the administration of Albutein® 20% and is being conducted at six Spanish hospitals; and

· a study designed to evaluate the effects of plasma exchange on the functional capacity of serum albumin on cerebral, circulatory and renal dysfunction.

All clinical trials involve risks and uncertainties. Preclinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more of our clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during or as a result of preclinical testing and the clinical trial process that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates. For a discussion of these unforeseen events, see Item 3. of this Part I, “Key Information — D. Risk Factors —Risks Relating to Our Business — We may not be able to commercialize products in development.” Upon the completion of each of the development stages we evaluate the results achieved as compared to the objectives pursued. Each of the key projects listed above has met our expectations with respect to results at the various development stages and we expect to move forward with the development process for each.

We believe that our current liquidity is sufficient to fund the ongoing costs of our key projects listed above through their completion as well as our other research and development initiatives.

Diagnostic Division Initiatives

Research and development in the Diagnostic division is focused on the development of recombinant proteins and in vitro diagnostic reagents and equipment, principally for pretransfusional testing, hemostasis diagnosis and biological drug monitoring. It is based on enzymatic and immunologic reactions and molecular genetic testing, using different technologies as RBC agglutination, latex particles agglutination, solid phase capture, lateral flow and chromogenic substrates. The Company has also been involved in research and development activities related to NAT testing of blood and plasma with molecular tests, and during 2017 it obtained FDA approval for a new genetic test to detect alpha-1 antitrypsin deficiency.

The principal research and development projects that we are undertaking in this division are: (i) development of recombinant proteins for the manufacture by third parties of finished kits, mainly for blood virus screening focused on HIV and hepatitis diagnosis, and also for the manufacture of Grifols finished kits for hemostasis testing as well as for the Immunohematology line of products; (ii) red blood cell typing tests and blood compatibility testing through the use of gel technology, liquid reagents and our patented Multicard device as well as the corresponding automated platforms (the division obtained FDA approval for the Erytra Eflexis analyzer to automate transfusion test based on gel cards) (iii) genetic detection of red blood cell and platelet antigens (the division obtained the approval of the ID Core XT (Reagents and Analysis Software) for the simultaneous identification of multiple alleles encoding human erythrocyte antigens in genomic DNA); (iv) the development of an automatic ELISA platform and a broad menu of drug and anti-drug ELISA kits; and (v) the development of a complete range of hemostasis reagents and automatic equipment;

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(vi) development of finished kits for NAT testing for infectious disease, including Zika virus detection; for which a BLA has been received from the FDA; and (vii) development of further multiplexed tests based on NAT technology.

In 2018 the Company received FDA approval for a genetic test for alpha-1 deficiency assessment, as well as started developing a fully automated Immunoassay platform for the serological testing of plasma and blood donations.

Additionally, the Diagnostic division is developing medical devices for the extraction and storage of blood components. In 2018, we received the marketing authorization approval from Spain CE Mark Notified Body for Leucored RC bags soft filter. The principal products under development were phthalate (DEHP)-free blood bags, Leucored Platelet kits, and Leucored WB bags.

Hospital Division Initiatives

Research and development in the Hospital division focuses on delivering products, integrated technology solutions, and services that improve safety, quality and efficiency in the operational pharmacy. The Hospital division is comprised of multiple subdivisions including IV Solutions, Contract Manufacturing and Pharmatech. Significant research and development activities are ongoing in each of these subdivisions.

The principal projects currently under development in the IV Solutions group (Laboratorios Grifols) are a flexible plastic container closure system for biological products, 0.9% Sodium Chloride in Fleboflex Luer needle-free container for the U.S., an anticoagulant solution, a nonsteroidal anti-inflammatory solution (NSAID) and two new presentations (2.5/5 and 15/20 ml) of sterile water for injection (SWFI) in vials. In addition to other applications, the Fleboflex Luer containers will also be used in the new Kiro Fill® system. During 2018, we received FDA marketing authorization approval for the 50, 100, 250 and 1000 ml physiological saline solution (0.9 % sodium chloride) manufactured at the Murcia facility and for a new set (peristaltic set) for the Gri-fill ® system in Europe and the U.S. In the fluid therapy market, work continues on the study of the stability of various ready-to-use mixtures in polypropylene packaging, in order to increase the range of mixtures available for hospital use.

This subdivision also works on several cross-divisional initiatives. As part of the AMBAR study, the Hospital division is collaborating on the development of special devices and containers specifically designed for the procedures and protocols of the study. There is collaboration with the Diagnostic division on the manufacturing of the cuvette of Q-Coagulometer. The partnership with the Bioscience division includes the development of a plastic holder for syringes of Fibrin Glue, among others. Within the Contract Manufacturing product group, devoted to offering development and manufacturing services for third parties, mainly in the U.S., the Hospital division has completed projects including a set for inactivation of red blood cells and milrinone IV ready-to-use flexible bags, which have been submitted to the regulatory authorities for approval.

While certain products were gaining FDA approval, commercial manufacturing commenced for products such as Tirofiban IV and Ibuprofen IV, both in ready-to-use flexible bags. Further projects are in the first phase of development, such as Fluconazol IV ready-to-use flexible bags. New projects, in the scope of ready-to-use IV mixtures, are in development.

Finally, the Pharmatech subdivision is devoted to the development of a comprehensive IV compounding portfolio of integrated technology solutions with devices, software, and services. The portfolio includes Grifols legacy products like the Gri-fill® system along with those more recently added from the acquisitions of MedKeeper and Kiro such as the PharmacyKeeper suite of software solutions, KIRO Oncology automated IV compounding system for oncology preparations and the KIRO Fill® system for automated filling of syringes which is currently under development. A new version of the Gri-fill® system is also being developed.

This subdivision has an active research and development program which includes the development of new software and state-of-the-art technology, such as cloud-based systems, mobile apps and Radio-Frequency Identification (RFID), to improve interoperability, efficiency and overall workflow and productivity in the operational pharmacy. Other fields of development include the traceability and inventory management of high cost implants and other medical devices.

Other Initiatives

In addition, we are increasing our research and development activities in new fields. We conduct these activities through the creation of joint ventures participated in by Grifols Innovation and New Technologies Ltd (GIANT), established in 2016, through agreements to use patents owned by third parties and through selective acquisitions.

Our acquisitions of Araclón and VCN Biosciences in 2012 expanded our research and development capabilities in fields outside of our traditional business segments. Araclón is dedicated to finding solutions that promote new diagnostic and therapeutic approaches to Alzheimer’s disease. Araclón is working on the validation of an early diagnostic kit and the development of a vaccine to combat Alzheimer’s disease in the asymptomatic preclinical stage. The vaccine has passed the animal experimentation stage and a

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Phase I clinical trial in humans has been completed. In 2017 Araclón obtained approval by the Spanish Drug Regulatory Agency (Agencia Española del Medicamento y Productos Sanitarios) of a Phase II trial of the AB40 vaccine in Alzheimer disease patients and started recruitment. By the end of 2018, 50% of the necessary patients had signed up to participate in the Phase II trial. VCN Biosciences is investigating and developing new therapeutic approaches based on oncolytic adenoviruses to treat tumors for which there is currently no effective treatment. Its most advanced project focuses of the treatment of pancreatic cancer. The Spanish Agency for Medicine and Health Products (Agencia Española del Medicamento y Productos Sanitarios) approved two Phase I clinical trials for this project and VCN Biosciences began recruiting patients for the Phase I trials in the first quarter of 2014. In 2017 VCN obtained approval by the Spanish Drug Regulatory Agency of another Phase I/II trial of VCN-01 in pediatric patients with Retinoblastoma.

In 2015 we initiated a partnership with Alkahest, acquiring 47.58% of the equity of the company, to develop plasma-based products for the treatment of cognitive decline in aging and other central nervous system (CNS) disorders, including Alzheimer’s disease. In 2017 Alkahest obtained approval by the FDA of a Phase I/II clinical trial of a plasma fraction (GRF-6019) in Alzheimer’s disease patients and the trial began in 2018. Also, a second trial of GRF-6019 was initiated in a population of severe Alzheimer’s disease patients. At the pre-clinical level, new potential clinical indications are being tested with plasma fractions.

In 2016, we acquired 30% of the equity of AlbaJuna Therapeutics, a spin-off company from the IrsiCaixa AIDS Research Institute, promoted jointly by “la Caixa” Foundation and the Department of Health of the Government of Catalonia, and established to promote the pre-clinical and clinical development of monoclonal antibodies that neutralize the effect of HIV in the body while increasing the activity of the natural killer cells that have the task of destroying infected cells. At the end of 2018, candidates for the trial treatment were preselected based on their biochemical and pharmacological characteristics in order to start preclinical development.

In 2017, we acquired a 43.96% equity stake in GigaGen Inc., a pre-clinical biotherapeutics company based in San Francisco (California) specialized in the research activities to develop recombinant plyclonal immunoglobulin therapies derived from human B cells for the treatment of human diseases. In 2018, Gigagen Inc. started to work in the development of Hyperimmune immunoglobulin.

In 2018, GIANT signed a collaboration agreement with IrsiCaixa AIDS Research Institute for five years to join forces to promote biomedical research on HIV and associated diseases.

Seasonality

Our businesses are not significantly affected by seasonal trends.

Raw Materials

The cost of plasma, the key raw material used in the production of plasma-derived products, slightly increased as compared to 2016, due to the investment plan to expand plasma collection centers in the United States to support growing demand for plasma proteins as well as the trend towards greater incentives to reward donors for their time. We continue to monitor the efficiency of our plasma collection platform and have concentrated all of our plasma testing into our two laboratories in Austin, Texas.

In June 2018, we completed the acquisition of Haema AG, a German based pharmaceutical company that owns 35 collection centers throughout Germany, for a purchase price of $220 million on a debt free basis. In August 2018, we completed the acquisition of Biotest US Corporation, a U.S. based pharmaceutical company that owns 24 plasma collection centers, for a purchase price of $286 million. In December 2018, we sold our 100% stake in Haema AG and Biotest US Corporation to Scranton Enterprises B.V., one of our major shareholders and a related party, for a total of $538 million. We will have the ability to repurchase the shares sold to Scranton Enterprises B.V. at any time. Our plasma supply agreement among Grifols, S.A., Grifols Worldwide Operations Limited, Biotest Pharmaceuticals Corporation and Haema AG, or the Plasma Supply Agreement, was effectively extended on January 1, 2019 for a 30-year period, and we continue to operate the companies’ plasma centers. See Item 5 of this Part I, “Operating and Financial Review and Prospects - A. Operating Results - Factors Affecting Our Financial Condition and Results of Operations - Acquisitions - Acquisition and Sale of Haema AG and Biotest Corporation” below. We believe our Plasma Supply Agreement will play a key role in fulfilling our plasma requirements through 2019 and beyond, along with plasma collected through our plasma collection centers and plasma purchased from third-party suppliers pursuant to various plasma purchase agreements.

The principal raw materials for our intravenous therapy products are plastic and glass bottles, which we purchase from various European suppliers.

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Marketing and Distribution

We currently sell Bioscience, Diagnostic and Hospital products to hospitals and clinics, GPOs, governments and other distributors in over 100 countries.

In the United States, the sales model is complex, with many intermediaries, requiring Grifols to execute multi-faceted arrangements for the distribution of our products. Sales of finished goods are distributed through various channels such as distributors, wholesalers, specialty pharmacies, home health care companies, clinics, hospitals, government entities and directly to physician offices. Payers and purchasers also control access to products, requiring separate negotiations with payers and GPO’s. GPO’s are entities that act as purchasing intermediaries for their members, which are primarily hospitals. GPO’s negotiate the price and volume of supplies, equipment and pharmaceutical products, including plasma derivatives, used by their members.

We market our products to healthcare providers and other decision-makers, such as those in hospitals, through focused sales presentations. Although price and volume are negotiated through contractual agreements with intermediaries, demand for our products is generated through promotional efforts by Grifols’ sales representatives. In the case of GPO’s, the actual sales are made to each GPO’s authorized distributor(s) at the contract price, and the distributor then sells the products to that GPO’s members. We promote our products directly to the GPO’s members. For safety and post-sale service reasons, the distributor is required to provide us with the specifics of the ultimate delivery to the client.

The sales, marketing and distribution process is different in Europe, where the bulk of sales are generally made directly to hospitals. We have developed long-standing relationships with major hospitals in most of our European markets, and we believe that hospitals are loyal customers that recognize the high quality and safety of our products, our reliability as a supplier and the strong product expertise and service provided by our sales representatives. Due to the nature of our customer base and the prevalence of repeat sales in the industry, we market our products through focused sales presentations rather than by advertising campaigns.

Sales to Eastern Europe, the Middle East and some Asian countries are made mostly by third parties outside of our sales network. Our sales in Latin America are made mainly by our sales network.

Sales Representatives

We require our sales representatives to be able to highlight the technical differences between our products and those of our competitors. This skill requires a high degree of training, as the salesperson must be able to interact and discuss product differences with doctors, pharmacists and other medical staff. Sales representatives call on office-based healthcare providers and hospital-based healthcare providers, departmental heads, purchasing agents, senior hospital directors, lab directors and pharmacy managers. We compensate our sales representatives by means of a fixed salary and a bonus component based on sales. We divide our sales efforts along the lines of our main product categories. Our sales personnel are primarily located in Europe and the United States, but we also have sales personnel in Latin America and Asia-Pacific.

In our Bioscience division, we utilize mixed sales units comprised of both marketing and sales personnel and product line-specific sales units for immunology & neurology, pulmonary, intensive care and coagulation factors.

Advertising

We participate in medical conferences and fairs and occasionally publish advertisements in medical journals and trade magazines. This promotional activity is also supported by online activities.

Distribution

We believe that having our own distribution network staffed with highly trained personnel is a critical element of a successful sales and marketing effort. Through this network, we are able to provide high-quality pre- and post-sales service, which we believe enhances brand recognition and customer loyalty. Our distribution network is experienced in the proper handling of our products and allows us to know where our products are located, enabling us to act quickly in the event of a suspected problem or product recall.

Our distribution network personnel are located in Europe, Latin America, the United States and Asia-Pacific and handle the distribution of our biological medicine, diagnostic and other medical products as well as goods manufactured by other premier healthcare companies that complement our own products.

During 2018, we distributed the majority of our products through our own distribution network. In some cases, particularly in the field of Diagnostics, we distribute products through marketing partners and third-party distributors. We have a direct presence in 30 countries and we carefully select distributors in the countries were we do not have a direct presence. We have a responsive, effective logistics organization that is able to punctually meet the needs of hospital centers and other customers throughout the world.

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Our sales, marketing and distribution network included 1,449 employees as of December 31, 2018, which included 1,265 sales and distribution personnel and 184 marketing employees.

Each of our commercial subsidiaries is responsible for the requirements of the local market. It is our goal for each commercial subsidiary to be recognizable as one of our companies by its quality of service, ethical standards and knowledge of customer needs. Strong local knowledge enables us to build and maintain long-term relationships with customers to earn their trust and confidence.

Patents, Trademarks and Licenses

Patents and Trademarks

Through our patent ownership, co-ownership and licensing, we seek to obtain and maintain intellectual property protection for our primary products.

As of December 31, 2018, we owned 2,965 patents and patent applications in various countries throughout the world, of which 600 are in the final application process. In some countries, these patents grant a 20-year protection period. 1,128 of these patents are set to expire in the next ten years. As of December 31, 2018, we also owned 3,188 trademarks in various countries throughout the world, of which 177 are in the final application process. In addition, we co-own certain patents and patent applications with third parties, including patent rights co-owned with Novartis following the Novartis Acquisition.

We maintain a department with personnel in Spain and in the United States to handle the patent and trademark approval and maintenance process and to monitor possible infringements.

Plasma Derivative Products

As of December 31, 2018, we owned 1,924 patents and patent applications related to plasma derivatives, including 971 in Europe, 152 in the United States and Canada and 801 in the rest of the world. The most important of these patents relate to:

· the process for the production of virus-inactivated human Gamma Globulin G;

· the process for removing viruses in fibrinogen solutions;

· the preparation of plasminogen;

· a concentrated subcutaneous Immunoglobulin G injection; and

· concentrated Immunoglobulin M preparations for the treatment of bacterial infections.

Hospital and Diagnostic Products

As of December 31, 2018, we owned 1,039 patents and patent applications related to our Hospital and Diagnostic products in Europe (643), the United States and Canada (105) and in the rest of the world (291). The most important of these patents relate to the:

· Gri-fill® System, a process for the sterile filling of flexible material bags;

· BlisPack®, a blister handling machine;

· Erytra Eflexys®, a mid-sized instrument to perform pre-transfusion compatibility tests using DG Gel® technology;

· innovative containers for human plasma proteins;

· blood screening antibodies, antigens and recombinant proteins; and

· screening assays for bloodborne parasites.

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As of December 31, 2018, we owned two patents and patent applications related to other areas of the business, including one in Europe and one in the United States and Canada.

Licenses from Third Parties

We license certain intellectual property rights from third parties, including Bayer, Singulex and Hologic. Under a licensing agreement with Bayer, Talecris was granted a royalty-free, worldwide and perpetual license covering certain intellectual properties not acquired by Talecris in connection with its formation transaction. We assumed this licensing agreement in connection with the Talecris acquisition. Singulex granted us an exclusive worldwide license under certain intellectual property rights for the use and sale of certain products and services for blood donor and plasma screening. Pursuant to an intellectual property license with Hologic, we obtained a fully paid-up license to certain of Hologic’s intellectual property for use in the NAT Donor Screening Unit.

Licenses from Government Authorities

Government authorities in the United States, at the federal, state and local level, and in other countries throughout the European Union, Latin America, Asia and elsewhere, through licenses, approvals, reviews, inspections and other requirements, extensively regulate the research, development, testing, approval, manufacturing, labeling, post-approval monitoring and reporting, packaging, promotion, storage, advertising, distribution, marketing and export and import of healthcare products such as those that we collect, manufacture, sell or are currently developing.

For example, in order to sell our plasma derivative products we must hold appropriate product licenses from applicable governmental authorities. We have 683 hemoderivative product licenses registered in 93 countries, which include the licenses we hold from the FDA for the sale in the United States of IVIG, A1PI, albumin, Factor VIII, Factor IX, ATIII and PTC. The production, marketing and sale of many of our Diagnostic division products are subject to the prior registration of such products with the relevant authorities of the applicable jurisdictions. We have over 2,323 diagnostic product licenses registered in a total of 71 countries in Europe, the United States, Canada, Latin America, Africa and Asia. With respect to our various Hospital division products, we have close to 187 licenses for our Hospital division products registered in 39 countries throughout the European Union, Latin America and the United States.

Governmental oversight extends to the various facilities involved in our operations. For example, our Parets and Murcia facilities are subject to applicable regulations and standards of the European health authorities. With respect to oversight by the FDA, our Instituto Grifols Bioscience plant at our Parets facility has been registered with the FDA since 1995, and our other manufacturing facilities maintain FDA registration, and all are subject to FDA standards. We lease most of our plasma collection centers as well as our main laboratory facility located in Austin, Texas, and maintain licenses with the appropriate regulatory authorities, including the FDA, for all of these locations.

For more information on government licenses and regulation, see “— Principal Activities” above and “— E. Regulatory Matters” below.

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Regulatory

For detailed information regarding the regulations applicable to our business, see “— E. Regulatory Matters” below.

Insurance Coverage

General and Product Liability

We have a program of insurance policies designed to protect us and our subsidiaries from product liability claims. Effective May 1, 2018, we have product liability insurance coverage for up to $220 million per claim and in annual aggregate for products manufactured in all of our facilities and for third-party products we sell. This policy expires on April 30, 2019. We have elected to self-insure the first $38.5 million per claim and in annual aggregate of our product liability policy through the purchase by one of our subsidiaries of such portion of the insurance policy. See “— Self-insurance” below.

Our master liability program also protects us and our affiliates from certain environmental liabilities arising in those countries in which our subsidiary companies have operations. This risk is covered up to a maximum of $220 million per claim and in annual aggregate.

Biomat USA and Talecris Plasma Resources maintain a separate liability insurance policy. The policy covers their professional liability for plasmapheresis business activities and expires on April 30, 2019. The maximum amount of coverage for liability claims under the policy is $15 million per claim and in the annual aggregate. In addition, we have general liability coverage for up to $220 million per claim and in the annual aggregate for Biomat USA and Talecris Plasma Resources.

Property Damage and Business Interruption

Our property damage and business interruption insurance program covers us and our subsidiaries (including our United States subsidiaries). This insurance program, which expires on April 30, 2019, covers damages suffered by plants and buildings, equipment and machinery. Under the current terms, the insurer will cover damages to our facilities produced by fire, smoke, lightning and explosions, among others, for up to $1.5 billion per occurrence. It also covers material damages produced by flooding, for up to €100 million per claim and in the annual aggregate.

In addition, this policy covers loss of profit for a period of 36 months with a deductible equivalent to up to five business days of lost profits. Pursuant to the loss of profit, in the event that any or all of our plants stop production due to an event not excluded under the policy, the insurer covers fixed expenses, in addition to net profits we did not earn during the term of coverage.

In addition, this policy covers property damage and business interruption caused by an earthquake in California, up to a limit of $20 million per year.

We also have a transit and inventory insurance program, which covers damages to raw materials, supplies, semi-finished products and finished products for up to $25 million per claim for transit and $650 million for inventory in annual aggregate.

Self-insurance

We are self-insuring part of the risks described above through the purchase of a portion of the relevant insurance policies by Squadron Reinsurance DAC, one of our wholly owned subsidiaries. We self-insure the first $38.5 million per claim per year of our product liability policy, the first €200,000 per loss for property damage and the first ten days of lost profits, the first $27,000 per claim for transit losses, the first €200,000 per claim for inventory losses and $15 million for damages caused by an earthquake in California. These amounts are in excess of the deductibles for each of the policies that make up our insurance programs.

C. Organizational Structure

Grifols, S.A. is the parent company of the Grifols Group, which was comprised at December 31, 2018, of 60 companies. Subsidiaries in which Grifols, S.A. directly or indirectly owned the majority of equity or voting rights have been fully consolidated. In addition, there were 15 companies that were accounted for using the equity method, because Grifols, S.A. owned between 20% and 50% of its share capital and had no power to govern its financial or operating policies.

See Notes 1 and 2(b) to our audited consolidated financial statements included in this annual report on Form 20-F for details of our consolidated and non-consolidated companies.

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D. Property, Plant and Equipment

Our headquarters is located in Barcelona, Spain. As of December 31, 2018, we owned or leased facilities in six countries. We currently own or lease manufacturing facilities in 10 sites in nine different locations, three of which have plasma fractionation capabilities. The table below shows the geographic location and business purpose of our principal properties as of December 31, 2018.

Location |  | Facility |  | Own/Lease (2) |  | Business Purpose
Parets del Vallès, Spain |  | Industrial Facility One Parets |  | 66% owned; 34% of the property is leased from a third party |  | Plasma fractionation Manufacture of plasma derivatives & division support activities
|  | Industrial Facility Two Parets |  | 80% owned; 20% of the property is leased from a third party |  | Manufacture of Diagnostic and Hospital products
|  | Industrial Facility Three Parets |  | 69% owned; 31% of the property is leased from a third party |  | Plasma storage & other operating activities
Los Angeles, California, USA |  | Industrial Facility USA |  | 92% owned; 8% of the property is leased from a third party |  | Plasma fractionation Plasma purification Manufacture of plasma derivatives
Clayton, North Carolina, USA |  | Clayton Facility |  | Own |  | Plasma fractionation Manufacture of plasma derivatives
Durham, North Carolina, USA |  | Research Triangle Park |  | 25% owned, 75% of the property is leased from a third party |  | Research and Development Labs and Offices
Emeryville, California, USA |  | Emeryville Facility |  | 79% owned; 21% of the property is leased from a third party |  | Manufacture of Diagnostic products
City of Industry, California, USA |  | City of Industry USA |  | Lease |  | Plasma storage
Murcia, Spain |  | Industrial Facility Murcia |  | 82% owned; 18% of the property is leased from a third party |  | Manufacture of Hospital products
Fribourg, Switzerland |  | Industrial Facility Switzerland |  | Lease |  | Manufacture of Diagnostic products
Melbourne, Australia |  | Industrial Facility Australia |  | Own |  | Manufacture of Diagnostic products
Austin, Texas, USA |  | Plasma Testing Lab |  | Lease |  | Plasma testing
San Marcos, Texas, USA |  | Plasma Testing Lab |  | Own |  | Plasma testing
San Diego, California |  | San Diego Facility |  | 76% owned; 24% of the property is leased from a third party |  | Manufacture of components of the TMA amplified NAT kits
Dublin, Ireland |  | Global Operations Center |  | Own(1) |  | Operating activities related to the Bioscience division
Sant Cugat del Vallès, Spain |  | Headquarters |  | Lease |  | Headquarters
Campo Largo, Curitiba, Brazil |  | Industrial Facility Brazil |  | Own |  | Manufacture of Diagnostic products

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(1) We hold a 999 year leasehold interest in the property.

(2) Lease percentage based on property size.

Plasma Fractionation Plants

Our plasma derivative products are manufactured at our Clayton, Los Angeles and Parets facilities. All of our fractionation facilities have FDA and EMA certification. The Spanish and American facilities currently have an aggregate fractionation capacity of approximately 14.8 million liters of plasma per year, and this capacity is sufficient to cover our current production needs.

The Parets facility has a fractionation capacity of 5.0 million liters per year and a unique design that separates the maintenance area from the clean areas required for the fractionation and purification procedures. This design, which we developed in house, minimizes the risk of contamination and reduces maintenance costs. In addition to licenses from the European Union and other authorities for the production of various plasma derivative products, the Parets facility is licensed by the FDA for the production of albumin and IVIG. We are one of the few European plasma derivatives plants to be licensed by the FDA. In addition to the plasma fractionation facilities, the Parets facility also has energy generation, research and development, packaging and storage facilities for the Bioscience division and manufacturing for the Hospital and Diagnostic divisions. The Parets facility holds ISO 14001 and ISO 9001 certifications for its parenteral solutions and diagnostic manufacturing facilities. In addition, the Clayton facility in North Carolina holds the ISO 14001 certification by TÜV Rheinland Iberica Inspection, Certification & Testing S.A. The ISO 14001 certification recognizes excellence and continuous improvement in environmental performance. The scope of the certification includes research, development, production and quality control of pharmaceutical specialties derived from human plasma at the Grifols Clayton facility.

We acquired our Los Angeles facility in July 2003, in connection with our acquisition of Alpha’s plasma fractionation business. We subsequently made significant capital investments in the facility, including the construction of purification and aseptic filling areas for coagulation factors, IVIG and albumin. The Los Angeles facility is subject to regulation by the FDA and it has a fractionation capacity of 2.4 million liters per year.

As a result of the Talecris acquisition, we acquired the Clayton facility. Since the acquisition, the Clayton facility has benefited from significant capital investment, including compliance enhancements, general site infrastructure upgrades, capacity expansions and new facilities, such as its chromatographic purification facilities and its high capacity sterile filling facility. The Clayton facility is one of the world’s largest fully integrated facilities for plasma-derived therapies, including plasma receiving, fractionation, purification, filling/freeze drying and packaging capabilities, as well as freezer storage, testing laboratories and a cGMP pilot plant for clinical supply manufacture. We completed construction and received FDA approval of the new Clayton fractionation plant in 2014, which expanded our fractionation capacity at Clayton by approximately 6.0 million liters per year, taking its fractionation capacity to 7.4 million liters per year as of 2018. In 2015 and 2016, we operated our two Clayton fractionation facilities while transitioning all fractionation to the newly constructed one. The transition of all significant production was successfully completed during 2016. We are currently working on a new fractionation plant in Clayton with 6.0 million liter capacity per year. We expect it will be in operation in 2021.

Global Operations Center

In the last quarter of 2015, we officially opened a global operations center for our Bioscience division. The new facilities, located in Dublin, Ireland, occupy 22,000 square meters. The new facility centralizes decision-making with regard to commercial policy, research and development policy and supply chain global management. It houses Bioscience’s global logistics and distribution activities; warehousing of plasma, intermediate paste and finished product, labelling, packaging and final conditioning of the product; as well as regulatory and quality activities relating to the supply of plasma and plasma derivatives. It also centralizes our treasury function and acts as our point of access to the capital markets.

We are currently building an albumin purification and filling plant that we expect will be in operation in 2021.

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E. Regulatory Matters

Government Regulation

Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, approval, manufacturing, labeling, post-approval monitoring and reporting, packaging, promotion, storage, advertising, distribution, marketing and export and import of healthcare products such as those we collect, manufacture, sell or are currently developing. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. The following is a summary of the overall regulatory landscape for our business.

United States Government Regulation

In the United States, the FDA regulates drugs, biologics, plasma collection and medical devices under the FDCA and, as applicable, the Public Health Service Act, or PHS Act, and their implementing regulations. Failure to comply with the applicable FDA requirements at any time during the product-development process, approval process or after approval may result in administrative or judicial sanctions. These sanctions could include, as applicable, the FDA’s imposition of a clinical hold on trials for drugs, devices or biologics, refusal to approve pending applications, withdrawal of an approval, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties or criminal prosecution or any combination of these sanctions. Any agency or judicial enforcement action could have a material adverse effect on us.

The BLA (Biologics License Application) Approval Process

Drugs that are also biological products, such as our plasma derivative products IVIG, A1PI, Factor VIII and albumin, and also certain in vitro diagnostic products associated with testing blood and blood components, must also satisfy the requirements of the PHS Act and its implementing regulations. In order for a biological drug product, or for these in vitro diagnostic tests, to be legally marketed in the United States, the product must have a BLA approved by the FDA.

The steps for obtaining FDA approval of a BLA to market a biological product in the United States include:

· completion of preclinical laboratory tests, animal studies and formulation studies under the FDA’s good laboratory practices regulations;

· submission to the FDA of an Investigational New Drug Application, or IND, for human clinical testing, which must become effective before human clinical trials may begin and which must include approval by an independent IRB at each clinical site before the trials may be initiated;

· performance of adequate and well controlled clinical trials in accordance with “Good Clinical Practice,” as set forth by the FDA, to establish the safety and efficacy of the product for each indication;

· submission to the FDA of a BLA, which contains detailed information about the chemistry, manufacturing and controls for the product, reports of the outcomes and full data sets of the clinical trials and proposed labeling and packaging for the product;

· satisfactory review of the contents of the BLA by the FDA, including the satisfactory resolution of any questions raised during the review;

· satisfactory completion of an FDA Advisory Committee review, if applicable;

· satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP to assure that the facilities, methods and controls are adequate to ensure the product’s identity, strength, quality and purity; and

· FDA approval of the BLA, including agreement on post-marketing commitments, if applicable.

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Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND. Some preclinical testing may continue after the IND is submitted. The IND must become effective before human clinical trials may begin. An IND will automatically become effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions about issues such as the conduct of the trials or supporting preclinical data as outlined in the IND. In that case, the IND sponsor and the FDA must resolve any outstanding FDA concerns or questions before clinical trials can proceed. In other words, submission of an IND may not result in the FDA allowing clinical trials to commence.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators. Clinical trials are conducted under strict requirements to ensure the protection of human subjects participating in the trial and protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB (usually, but not necessarily specific to each study site) must approve the protocol, subject consent form and any amendments. All research subjects must be informed, among other things, about the risks and benefits of the investigational product and provide their informed consent in writing.

Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined.

Phase I trials usually involve the initial introduction of the investigational drug into a small group of healthy volunteers (e.g., ten to 20 volunteers) to evaluate the product’s safety, dosage tolerance and pharmacokinetics and, if possible, to gain an early indication of its effectiveness.

Phase II trials usually involve controlled trials in a larger but limited patient population (e.g., a few hundred) to:

· evaluate dosage tolerance and appropriate dosage;

· identify possible adverse effects and safety risks; and

· provide a preliminary evaluation of the efficacy of the drug for specific indications.

Phase III trials usually further evaluate clinical efficacy and test further for safety in an expanded patient population (e.g., several hundred to several thousand patients). Phase III trials usually involve comparison with placebo, standard treatments or other active comparators. Usually two well controlled large Phase III or pivotal trials demonstrating safety and efficacy are required. These trials are intended to establish the overall risk-benefit profile of the product and provide an adequate basis for physician labeling. Phase III trials are usually larger, more time consuming, more complex and more costly than Phase I and Phase II trials. Since most of our products are aimed at very small populations so that it is not always possible to conduct two large studies, regulators may accept one study on a smaller number of patients than would typically be required for pharmaceutical products in general, provided the data is sufficiently robust.

Phase I, Phase II and Phase III testing may not be completed successfully within any specified period, if at all. Furthermore, we or the FDA may suspend or terminate clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk, have experienced a serious and unexpected adverse event, or that continued use in an investigational setting may be unethical. Similarly, an IRB can suspend or terminate approval of research if the research is not being conducted in accordance with the IRB’s requirements or if the research has been associated with unexpected serious harm to patients.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators, including reports regarding adverse events and safety issues.

Assuming successful completion of the required clinical testing, the results of the preclinical studies and of the clinical trials, together with other detailed information, including information on the chemistry, manufacture and composition of the product, are submitted to the FDA in the form of a BLA requesting approval to market the product for one or more indications. Under the Pediatric Research Equity Act of 2003, BLAs, or supplements to BLAs, must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, the Pediatric Research Equity Act of 2003 does not apply to any drug for an indication for which orphan designation has been granted. The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all. In most cases, the BLA must be accompanied by a substantial user fee.

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The FDA will initially review the BLA for completeness before it accepts the BLA for filing. After the BLA submission is accepted for filing, the FDA reviews the BLA to determine, among other things, whether a product is safe and effective for its intended use and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality, purity and potency. The FDA may refer applications for novel biological products or biological products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation, and recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of the advisory committee, but it considers such recommendations carefully when making decisions.

Under the Pediatric Research Equity Act of 2003, BLAs, or supplements to BLAs, must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant deferrals for submission of data or full or partial waivers. Unless otherwise required by regulation, the Pediatric Research Equity Act of 2003 does not apply to any drug for an indication for which orphan designation has been granted.

Before approving a BLA, the FDA generally will inspect the facility or the facilities at which the product is manufactured. The FDA will not approve the product if it finds that the facility does not appear to be in cGMP compliance. If the FDA determines the application, manufacturing process or manufacturing facilities are not acceptable, it will either disapprove the application or issue a complete response letter in which it will outline the deficiencies in the BLA and provide the applicant an opportunity to meet with FDA representatives and subsequently to submit additional information or data to address the deficiencies. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

Further, the Healthcare Reform Law introduced a new abbreviated regulatory approval pathway for biological products found to be “biosimilars” or “interchangeable” with a biological “reference product” previously licensed under a BLA. This abbreviated approval pathway is intended to permit a biosimilar to come to market more quickly and less expensively by relying to some extent on the data generated by the reference product’s sponsor, and the FDA’s previous review and approval of the reference product. The law provides that no biosimilar application may be accepted for FDA review until 4 years after the date the reference product was first licensed by the FDA, and that the FDA may not make approval of an application effective until 12 years after the reference product was first licensed. Once approved, biosimilars likely would compete with, and in some circumstances may be deemed under applicable laws to be “interchangeable with,” the previously approved reference product. The extent to which a biosimilar, once approved, will be substituted for any of our products, in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. The FDA is actively seeking to encourage the entry of biosimilars into the marketplace, including issuing, in July 2018, its Biosimilar Action Plan, intended to enhance the speed of the biosimilar development and approval processes.

The testing and approval processes require substantial time, effort and financial resources, and each process may take several years to complete. Data obtained from clinical activities is not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval on a timely basis, or at all. We may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental approvals, which could delay or preclude us from marketing our products. The FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the products.

Post-approval Requirements

After regulatory approval of a product is obtained, we are required to comply with a number of post-approval requirements. For example, as a condition of approval of a BLA, the FDA may require post-marketing testing and surveillance to monitor the product’s safety or efficacy. In addition, holders of an approved BLA are required to keep extensive records, to report certain adverse reactions and production problems to the FDA, to provide updated safety and efficacy information and to comply with requirements concerning advertising and promotional labeling for their products. Also, quality control and manufacturing procedures must continue to conform to cGMP regulations and practices, as well as the manufacturing conditions of approval set forth in the BLA. The FDA periodically inspects manufacturing facilities to assess compliance with cGMP, which imposes certain procedural, substantive and recordkeeping requirements. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

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Future FDA inspections may identify compliance issues at our facilities or at the facilities of our third-party suppliers that may disrupt production or distribution, or require substantial resources to correct and prevent recurrence of any deficiencies, and could result in fines or penalties by regulatory authorities. In addition, discovery of problems with a product or the failure to comply with applicable requirements may result in restrictions on a product, manufacturer or holder of an approved BLA, including withdrawal or recall of the product from the market or other voluntary, FDA-initiated or judicial action that could delay or prohibit further marketing. Newly discovered or developed safety or efficacy data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications. The Healthcare Reform Law established and provided significant funding for a Patient-Centered Outcomes Research Institute to coordinate and fund Comparative Effectiveness Research. Also, new government requirements, including those resulting from new legislation, may be established that could delay or prevent regulatory approval of our products under development.

Orphan Drug Designation

The FDA may grant orphan drug designation to drugs intended to treat a “rare disease or condition” that affects fewer than 200,000 individuals in the United States, or that affects more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such a disease or condition will be recovered from sales in the United States for that drug. Orphan drug designation must be requested before submitting an application for marketing approval. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. Orphan drug designation can provide opportunities for grant funding towards clinical trial costs, tax advantages and FDA user fee exemptions. In addition, if a product that has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity or a meaningfully different mode of administration. Competitors may receive approval of different drugs or biologics for the indications for which the orphan product has exclusivity. However, if a company with orphan drug exclusivity is not able to supply the market, the FDA could allow another company with the same drug a license to market for said indication. The FDA granted Gamunex® IVIG orphan drug status, which provided marketing exclusivity for the CIDP indication in the United States through September 2015. Gamunex® IVIG was the first IVIG product approved for CIDP in the United States.

Fast Track Designation

The FDA’s fast track programs, one of which is fast track designation, are designed to facilitate the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for the conditions. Fast track designation applies to a combination of the product and the specific indication for which it is being studied. Thus, it is the development program for a specific drug for a specific indication that receives fast track designation.

The sponsor of a product designated as being in a fast track drug development program may engage in close early communication with the FDA, including through timely meetings and feedback on clinical trials. Products in fast track drug development programs also may receive FDA priority review or accelerated approval; in other words, the review cycle has a six-month review clock instead of a ten- or 12-month review clock). Sponsors may also be able to submit completed portions of an application before the entire application is completed; however, the review clock will not officially begin until the entire completed BLA is submitted to and filed by the FDA. The FDA may notify a sponsor that its program is no longer classified as a fast track development program if the fast track designation is no longer supported by emerging data, the designated drug development program is no longer being pursued, or another product that meets the unmet medical need for the same indication is approved first. We do not currently have any products on fast track.

Plasma Collection

The FDA requires a licensing and certification process for each plasma collection center prior to opening and conducts periodic inspections of facilities and processes. Many states also regulate plasma collection, imposing similar obligations and additional inspections and audits. Collection centers are subject to periodic inspections by regulatory authorities, which if noncompliance is alleged, may result in fines, citations, the temporary closing of the centers, loss or suspension of licenses or recall of finished products.

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Diagnostic Devices

Certain of our products are regulated as medical devices, which are typically subject to clearance for commercialization in the United States, based on a pre-market notification to the FDA demonstrating the device to be marketed is safe and effective by proving substantial equivalence to a legally marketed device (predicate device). The manufacturers of medical devices must register their establishments with the FDA, and the production of the devices must accord with applicable current good manufacturing practices and quality system regulations. With respect to the manufacture and sale of immunoassay antigens and antibodies to screen human donated blood and blood products, these products are manufactured and sold under a BLA issued by the FDA, and are subject to the heightened regulatory oversight associated with biological products.

Drug Supply Chain Security Act

The federal Drug Quality and Security Act of 2013 brought about significant changes with respect to pharmaceutical supply chain requirements and pre-empts state law. Title II of this measure, known as the Drug Supply Chain Security Act, or the DSCSA, is being phased in over 10 years, and is intended to build a national electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, including certain of our products. The law’s track and trace requirements applicable to manufacturers, wholesalers, repackagers and dispensers (e.g., pharmacies) of prescription drugs began to take effect in January 2015 and will continue to be implemented. The DSCSA product tracing requirements replaced the former FDA drug pedigree requirements and pre-empt state requirements that are inconsistent with, more stringent than, or in addition to, the DSCSA requirements. The DSCSA also establishes certain requirements for the licensing and operation of prescription drug wholesalers and third party logistics providers, or 3PLs, and includes the creation of national wholesaler and 3PL licenses in cases where states do not license such entities. The DSCSA requires that wholesalers and 3PLs distribute drugs in accordance with certain standards regarding the recordkeeping, storage and handling of prescription drugs. According to FDA guidance, states are pre-empted from imposing any licensing requirements that are inconsistent with, less stringent than, directly related to, or covered by the standards established by federal law in this area. Current state licensing requirements will likely remain in effect until the FDA issues new regulations as directed by the DSCSA. We believe that we are substantially compliant with applicable DSCSA requirements.

Anti-fraud and Abuse Regulation

Since we supply products and services that are reimbursed by U.S. federally funded programs such as Medicare and Medicaid, our activities are also subject to regulation by CMS and enforcement by HHS OIG. The Anti-Kickback Law prohibits providers and others from directly or indirectly soliciting, receiving, offering or paying any remuneration with the intent of generating referrals or orders for services or items covered by a government health care program. Many states have similar laws. Courts have interpreted this law very broadly, including by holding that a violation has occurred if even one purpose of the remuneration is to generate referrals, even if there are other lawful purposes. There are statutory and regulatory exceptions, or safe harbors, that outline arrangements that are deemed lawful. However, the fact that an arrangement does not fall within a safe harbor does not necessarily render the conduct illegal under the Anti-Kickback Law. In sum, even legitimate business arrangements between the companies and referral sources could lead to scrutiny by government enforcement agencies and require extensive company resources to respond to government investigations. Also, certain business practices, such as payment of consulting fees to healthcare providers, sponsorship of educational or research grants, charitable donations, interactions with healthcare providers that prescribe products for uses not approved by the FDA and financial support for continuing medical education programs, must be conducted within narrowly prescribed and controlled limits to avoid any possibility of wrongfully influencing healthcare providers to prescribe or purchase particular products or as a reward for past prescribing. Violations of the Anti-Kickback Law can result in substantial legal penalties, including, among others, civil and criminal penalties or exclusion from participation in federal health care programs, including Medicare and Medicaid. Notably, effective October 24, 2018, a new federal anti-kickback law (the Eliminating Kickbacks in Recovery Act of 2018) enacted in connection with broader addiction services legislation, may impose criminal penalties for kickbacks involving clinical laboratory services regardless of whether the services at issue involved addiction services, and regardless of whether the services were reimbursed by a federal health care program or by a commercial health insurer. The Healthcare Reform Law strengthened provisions of the Anti-Kickback Law, clarifying that a federal Anti-Kickback Law violation can be a basis for federal FCA liability.

The FCA is violated by any entity that “presents or causes to be presented” knowingly false claims for payment to the federal government. In addition, the Healthcare Reform Law amended the FCA to create a cause of action against any person who knowingly makes a false statement material to an obligation to pay money to the government or knowingly conceals or improperly decreases an obligation to pay or transmit money or property to the government. For the purposes of these recent amendments, an “obligation” includes an identified overpayment, which is defined broadly to include “any funds that a person receives or retains under Medicare and Medicaid to which the person, after applicable reconciliation, is not entitled …”

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Significant enforcement activity has been the result of actions brought by relators, who file complaints in the name of the United States (and, if applicable, particular states) under the FCA or equivalent state statutes. “False claims” can result not only from noncompliance with the express requirements of applicable governmental reimbursement programs, such as Medicaid or Medicare, but also from noncompliance with other laws, such as the Anti-Kickback Law (which was explicitly confirmed in the Healthcare Reform Law), or laws that require quality care in service delivery. The qui tam and whistleblower provisions of the FCA allow private individuals to bring actions on behalf of the government alleging that the government was defrauded, with tremendous potential financial gain (up to 30% of the government’s recovery plus legal fees) to private citizens who prevail. When a private party brings a whistleblower action under the FCA, the qui tam plaintiffs file the complaint under seal and serve the complaint on the government only, with written disclosure of substantially all material evidence and information they possess. The government then uses the information provided by the qui tam plaintiff to investigate the claims and may elect to intervene in the case within 60 days of receiving the complaint, unless extended for good-cause. The defendant is not made aware of the lawsuit until the case is unsealed. Many states have enacted similar laws, and these state laws have their own penalties which may be in addition to federal FCA penalties. The bringing of any federal FCA action could require us to devote resources to investigate and defend the action. Violations of the FCA can result in treble damages, plus civil penalties of up to $22,363 per claim, as well as exclusion from federal health care programs and criminal penalties.

A Healthcare Reform Law provision, generally referred to as the PPS Act or Open Payments Program, has imposed new reporting and disclosure requirements for biologic, drug and device manufacturers with regard to payments or other transfers of value made to certain practitioners, such as physicians and teaching hospitals, and for such manufacturers and for group purchasing organizations, with regard to certain ownership interests held by physicians in the reporting entity. CMS publishes information from these reports on a publicly available website, including amounts transferred and health care provider identities. Under the PPS Act we are required to collect and report detailed information regarding certain financial relationships we have with covered health care providers, and we believe that we are substantially compliant with applicable PPS Act requirements. The PPS Act pre-empts similar state reporting laws, although we or our subsidiaries may also be required to report under certain state transparency laws that address circumstances not covered by the PPS Act, and some of these state laws are also ambiguous. We are also subject to foreign regulations requiring transparency of certain interactions between suppliers and their customers. While we believe we have substantially compliant programs and controls in place to comply with these reporting requirements, our compliance with these rules imposes additional costs on us.

European Community Government Regulation

In addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing clinical trials and commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of countries outside the United States before we can commence marketing that product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. Also, in addition to approval of final products, plasma centers collecting plasma for manufacture into products to be distributed in the European Union must also be approved by the competent European health authority.

Medicines can be authorized in the European Union by using either the centralized authorization procedure or national authorization procedures. The EMA is responsible for the centralized authorization procedure.

Centralized Authorization Procedure

The EMA is responsible for the centralized procedure, or Community authorization procedure, for human medicines. This procedure results in Community marketing authorization, the single marketing authorization that is valid across the European Union, as well as in the European Economic Area/European Free Trade Association states Iceland, Liechtenstein and Norway.

The Community authorization procedure is compulsory for:

· medicines derived from biotechnology processes, such as genetic engineering;

· advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;

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· medicinal products for human use containing a new active substance that did not receive Community marketing authorization when the Community authorization procedure was first implemented, for which the therapeutic indication is the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, autoimmune diseases and other immune dysfunctions or viral diseases; and

· officially designated orphan medicines (medicines for rare diseases).

The Community authorization procedure is optional for products:

· containing new active substances for indications other than the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, autoimmune diseases and other immune dysfunctions or viral diseases;

· representing significant therapeutic, scientific or technical innovations; or

· for which the granting of a Community marketing authorization would be in the interests of European Union public health.

Our blood derivative products are not subject to compulsory Community authorization, but it is an option for our new products. Flebogamma® DIF 50 mg/ml and 100 mg/ml and VeraSeal solutions for sealant were approved through the Community authorization procedure.

Applications through the Community authorization procedure are submitted directly to the EMA. Evaluation by the EMA’s relevant scientific committee takes up to 210 days, at the end of which the committee adopts an opinion on whether the medicine should be marketed. This opinion is then transmitted to the European Commission, which has the ultimate authority for granting marketing authorizations in the European Union.

Once a Community marketing authorization has been granted, the holder of that authorization can begin to make the medicine available to patients and healthcare professionals in all European Union countries.

National Authorization Procedures

Each European Union member state has its own procedures for the authorization, within its own territory, of medicines that fall outside the scope of the Community authorization procedure. There are two possible routes available to companies for the authorization of such medicines in several countries simultaneously.

· Decentralized procedure. Using the decentralized procedure, companies may apply for simultaneous authorization in more than one European Union country of medicines that have not yet been authorized in any European Union country and that do not fall within the mandatory scope of the centralized procedure.

· Mutual-recognition procedure. In the mutual-recognition procedure, a medicine is first authorized in one European Union member state, in accordance with the national procedures of that country. Following such authorization, further marketing authorizations can be sought from other European Union member states in a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization.

Our product Niuliva 250 I.U./ml was approved through the decentralized procedure. Our products Prolastina® 1000 mg/ml and Gamunex® 10% were approved through the mutual-recognition procedure. All our other products were approved pursuant to individual national procedures. We expect to use the mutual-recognition procedure if we want to extend our product licenses to other European countries in the future.

In some cases, disputes arising in these procedures can be referred to the EMA for arbitration as part of a “referral procedure.”

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Orphan Drug Designation

Applications for designation of orphan medicines are reviewed by the EMA through the Committee for Orphan Medicinal Products. The criteria for orphan designation are:

· the medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union at the time of submission of the designation application (prevalence criterion); or

· the medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition, and without incentives it is unlikely that the revenue after marketing of the medicinal product would cover the investment in its development; and

· either no satisfactory method of diagnosis, prevention or treatment of the condition concerned is authorized, or, if such method exists, the medicinal product will be of significant benefit to those affected by the condition.

Companies with an orphan designation for a medicinal product benefit from incentives such as:

· protocol assistance (scientific advice for orphan medicines during the product-development phase);

· direct access to centralized marketing authorization and 10-year marketing exclusivity;

· financial incentives (fee reductions or exemptions); and

· national incentives detailed in an inventory made available by the European Commission.

Since December 2011, orphan medicinal products are eligible for the following level of fee reductions:

· full (100%) reduction for small- and medium-sized enterprises, or SMEs, for protocol assistance and follow-up, full reduction for non-SME sponsors for pediatric-related assistance and 75% reduction for non-SME sponsors for non-pediatric assistance;

· To determine which companies are eligible for SME incentives, the EMA applies the definition of micro-, small- and medium-sized enterprises provided in the Commission of the European Communities’ Commission Recommendation 2003/361/EC. To qualify for assistance, companies must be established in the European Economic Area, employ less than 250 employees and have an annual turnover of not more than €50 million or an annual balance sheet total of not more than €43 million.

· full reduction for pre-authorization inspections and 90% reduction for post-authorization inspections for small- and medium-sized enterprises;

· full reduction for SMEs for new applications for Community marketing authorization and 10% reduction for non-SME sponsors; and

· full reduction for post-authorization activities including annual fees only to small and medium sized enterprises in the first year after granting a marketing authorization.

We have EMA Orphan Drug Designations for the following 2 products:

· Alpha-1 proteinase inhibitor (for inhalation use) for the treatment of cystic fibrosis; and

· Alpha-1 proteinase inhibitor (for inhalation use) for the treatment of congenital alpha-1 antitrypsin deficiency.

Because each of these products is already authorized for a non-orphan indication in the EU, in order to obtain marketing authorization for any of the above-mentioned orphan indications, we would be required to apply for a separate marketing authorization through the Community authorization procedure for such indication, using a different proprietary name. It is not be possible to extend the existing marketing authorization to cover the new orphan indication. Orphan and “non-orphan” indications cannot be covered by the same marketing authorization.

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Canadian Regulatory Process

Authorization to Market. Therapeutic products can be marketed in Canada after they have been subject to a review to assess their safety, efficacy and quality. A New Drug Submission must be submitted to Health Canada for review, and a Notice of Compliance, or NOC, and/or a Drug Identification Number, or DIN, must be received by the sponsor prior to marketing a product in Canada. Responsibility for review of pharmaceutical drug products resides with Health Canada’s Therapeutic Products Directorate, or TPD, while responsibility for review of biological products is under the Biologics, Radiopharmaceuticals and Genetic Therapies Directorate, or BGTD. An active DIN is required for any product being marketed in Canada. Our IVIG, A1PI, albumin and hyperimmune products are subject to these review and authorization processes.

Changes to Market Authorization. There are four classes of changes to existing market authorizations in Canada. Level 1 changes are considered “significantly different” and have the potential to impact safety, efficacy, quality or effectiveness of the product. These require the filing of a Supplemental New Drug Submission, and a NOC must be issued by Health Canada prior to implementation of the change. Level 2 changes are not considered “significant,” but a “Notifiable Change” submission must be filed to Health Canada for review, and approval is provided via a “No Objection” letter to the sponsor. Level 3 changes have minimal potential to impact safety, quality or effectiveness and can be made without prior approval of Health Canada; a summary of these changes is reported to Health Canada with the sponsor’s Annual Drug Notification. Level 4 changes are implemented without any notification to Health Canada, based on no expectation of risk.

Clinical Trials. A Clinical Trial Application, or CTA, must be submitted to Health Canada prior to conducting any study protocol that proposes the use of a new product, or the use of an existing product, where the indication, target population, route of administration or dosing differs from the current market authorization. The CTA should include summaries of preclinical and clinical studies conducted and (if applicable) chemistry, manufacturing and control data, and is submitted to either TPD (for drug products) or BGTD (for biological products) for review. The TPD or BGTD are responsible for assessing protection and safety of the participants as well as quality of the product; they will issue a “No Objection” letter to sponsors for studies deemed acceptable. Research ethics board approval for each trial is also required prior to conduct of the study.

Establishment Licensing. All establishments in Canada that are involved in the fabrication, packaging/labeling, testing, import, distribution or warehousing of drug products must have a current establishment license (once an establishment license is issued, an annual report must be submitted by April 1 of each year to maintain the effectiveness of that license). As an importer/distributor, part of the licensing requirements include demonstration that any foreign (non-Canadian) facilities involved in fabrication, packaging/labeling or testing of products imported/distributed under the license comply with cGMP.

Post-Approval Requirements. The Health Products and Food Branch Inspectorate of Health Canada periodically inspects licensed establishments in Canada to verify compliance with cGMP. Manufacturers and importers are required to monitor the safety and quality of their products and must report adverse reactions to the Marketed Health Products Directorate in accordance with a prescribed timeline and format.

Regulatory Process for Markets outside the United States, Canada and Europe

The majority of regulatory authorities in countries outside the United States, Canada and Europe require that a product first be approved by the FDA or European authority prior to granting the market authorization in their country. There are a limited number of countries (Bahamas, Bermuda, Guam, Oman and Qatar) that do not require further local product registration for products and they may be distributed based on the existing FDA approval.

In addition to requiring the submission of a license application containing documentation supporting the safety, efficacy and quality of the product, many countries require the submission of FDA Export Certificates for our products to provide assurance that such products can be legally marketed in the United States. The Certificate of Pharmaceutical Product, or CPP, and/or the Certificate to Foreign Government, or CFG, are issued by the FDA at the request of the manufacturer seeking licensing in the country outside the United States. The CPP conforms to the format established by the World Health Organization, or WHO, and is intended for use by the importing country when considering whether to license the product in question for sale in that country. The CFG serves to document that the product can be legally marketed in the United States and the manufacturer is in compliance with GMP. A limited number of regulatory authorities in countries outside United States, Canada and Europe conduct onsite inspections to verify GMP compliance. Failure to maintain and document GMP compliance could result in withdrawal of marketing authorization. In addition changes to manufacturing or testing procedures for the product require approval of the change in the United States prior to the submission of the variation to the registration in the international market. These changes may require approval in each market in order to maintain product distribution. Furthermore, any changes in the distributors supporting our export business could result in a loss of sales.

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Pharmaceutical Pricing and Reimbursement

In the United States and other countries, sales of any products for which we receive regulatory approval for commercial sale will depend in part on the availability of reimbursement from third-party payors. Third-party payors include government health programs, managed care providers, private health insurers and other organizations. These third-party payors are increasingly challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products. Our products may not be considered cost-effective. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

In the United States, our products are reimbursed or purchased under several government programs, including Medicaid, Medicare Parts B and D and the 340B/PHS program, and pursuant to our contract with the Department of Veterans Affairs. Medicaid is a joint state and federal government health plan that provides covered outpatient prescription drugs for low income individuals. Under Medicaid, drug manufacturers pay rebates to the states based on utilization data provided by the states. The rebate amount for most brand name drugs is the greater of 23.1% of the AMP per unit or the difference between the AMP and Best Price per unit and adjusted by the CPI-U, subject to certain exceptions (for example, for certain clotting factors, such as Factor VIII and Factor IX, of the rebate amount is the greater of 17.1% of the AMP per unit or the difference between the AMP and the Best Price per unit and adjusted by the CPI-U. For non-innovator multiple source (generic) drugs, the rebate percentage is equal to a minimum of 13.0% of AMP. The Healthcare Reform Law also extended this rebate obligation to prescription drugs covered by Medicaid managed care organizations.

In addition, the statutory definition of AMP changed in 2010 as a result of the Healthcare Reform Law. On January 21, 2016, CMS issued a final rule, effective on April 1, 2016, providing a regulatory definition of “AMP” along with other changes to the price reporting process. We believe our reporting meets the obligations contained in the final rule.

Medicare Part B reimburses providers for drugs provided in the outpatient setting based upon ASP. Beginning in 2005, the Medicare drug reimbursement methodology for physician and hospital outpatient schedules changed to ASP + 6%. This payment was based on a volume-weighted average of all brands under a common billing code. After changes in certain prior years, CMS increased the rate back to + 6% for 2013 and maintained the same rate for 2014 through 2019, except that effective January 1, 2018, a new CMS rule went into effect substantially cutting reimbursement paid to hospitals and other providers for certain outpatient drugs and biologicals, including certain of our products, if purchased by these providers under the 340B/PHS program. The reimbursement was decreased from ASP + 6% to ASP - 22.5%. However, on December 27, 2018, the Federal District Court for the District of Columbia issued an opinion finding that this reimbursement cut exceeded CMS’s regulatory authority. No final remedy has yet resulted from this decision, and the case remains subject to appeal. The outcome of this reimbursement change on our business is uncertain, but it may decrease demand for our products and have an adverse effect on our business. We believe that we meet the requirements of the 340B/PHS program and are continuing to review and monitor these and other developments affecting the 340B/PHS program. In addition, under the Bipartisan Budget Act of 2013 and subsequent measures, Medicare is subject to a 2% reduction in federal spending, or “sequestration,” including drugs reimbursed under Medicare, for federal fiscal years 2013 through 2025. The full ramifications of this sequestration for Medicare reimbursement are not yet clear, as Congressional action may reduce, eliminate or otherwise change this payment reduction.

Other pricing concerns in the United States include that in May 2018, President Trump released a drug “blueprint” including an array of policy ideas intended to lower drug prices and patient out-of-pocket drug costs, and federal administrative agencies have begun issuing proposed regulations to adopt various of these proposals. An area of focus are drugs reimbursed under Medicare Part B. The proposals include, for example, moving reimbursement for certain Medicare Part B drugs into Medicare Part D to make them subject to a variety of pricing negotiations, establishing an enhanced competitive acquisition program for Medicare Part B drugs, and instituting an “International Pricing Index” payment model that would link reimbursement for certain Medicare Part B drugs to pricing levels for such drugs found in other countries. Other proposals support the marketing of biosimilars, involve lowering standards for demonstrating biosimilarity. One additional proposal, which was published as a proposed rule by the Office of Inspector General of the Department of Health and Human Services on February 6, 2019, and is focused initially on drugs reimbursed under Medicare Part D and certain Medicaid managed care organizations (although comments were sought as to whether its scope should be expanded, including to Medicare Part B drugs), would substantially disrupt current pharmaceutical market practices by apparently rendering illegal, under the federal Anti-Kickback Statute, many drug rebates now routinely paid by drug manufacturers to such health benefit plans or their pharmacy benefit managers (PBMs). The uncertain status of these various pricing proposals, some of which could take effect based on action by federal administrative agencies without the need for Congressional action, affects our ability to plan, and the proposals, if adopted, in whole or in part, could adversely affect our business.

An increasing number of states in the United States have also proposed or passed legislation that seeks to directly or indirectly regulate pharmaceutical drug pricing, such as by requiring drug manufacturers to publicly report pricing information or to

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place a maximum price ceiling on pharmaceutical products purchased by state agencies. For example, in October 2017, California enacted a prescription drug price transparency law that requires prescription drug manufacturers to provide advance notice and explanation for certain drug price increases that exceed a specified threshold. Laws of this type may cause us to experience additional pricing pressures on our affected products, and could adversely affect our business.

Medicare Part D is a partial, voluntary prescription drug benefit created by the federal government primarily for persons 65 years old and over. The Medicare Part D drug program is administered through private insurers that contract with CMS. Government payment for some of the costs of prescription drugs may increase demand for any products for which we receive marketing approval. However, to obtain payments under this program, we are required to negotiate prices with private insurers operating pursuant to federal program guidance. These prices may be lower than we might otherwise obtain. In addition, beginning in 2011, the Healthcare Reform Law generally required that we provide a 50% discount (the “Coverage Gap Discount”) to patients who have expended certain amounts for drugs and therefore fall within the Medicare Part D coverage gap. In February 2018, legislation was enacted as part of the Bipartisan Budget Act of 2018 that increased this coverage gap discount to 70%, and extended the price reductions of the Coverage Gap Discount Program to include biosimilar drugs.

The availability of federal funds to pay for our products under the Medicaid and Medicare Part B programs requires that we extend discounts under the 340B/PHS drug pricing program. The 340B/PHS drug pricing program extends discounts to a variety of community health clinics and other specified entities that receive health services grants from the PHS, as well as hospitals that serve a disproportionate share of certain low income individuals. The PHS ceiling price cannot exceed the AMP (as reported to CMS under the Medicaid drug rebate program) less the Medicaid unit rebate amount. We have entered into a PPA with the government in which we agree to participate in the 340B/PHS program by charging eligible entities no more than the PHS ceiling price for drugs intended for outpatient use. Evolving requirements with respect to this program continue to be issued by the HRSA of HHS, the federal agency responsible for oversight of the 340B/PHS program, which creates uncertainty. For example, effective January 1, 2019, a final HRSA rule codified standards regarding the calculation of the ceiling price for covered outpatient drugs under the 340B/PHS program, as well as regarding the imposition of civil monetary penalties, or CMP, on manufacturers that knowingly and intentionally overcharge covered entities.

We make our products available for purchase by authorized government users of the Federal Supply Schedule, or FSS, pursuant to their FSS contracts with the Department of Veterans Affairs. Under the Veterans Health Care Act of 1992, companies are required to offer discounted FSS contract pricing to four federal agencies — the Department of Veterans Affairs, the Department of Defense, the Coast Guard and the PHS (including the Indian Health Service) — for federal funding to be made available for reimbursement of products under the Medicaid program and products eligible to be purchased by those four federal agencies. FSS pricing to those four federal agencies must be equal to or less than the ceiling price, which is, at a minimum, 24% off the non-federal AMP for the prior fiscal year.

The Healthcare Reform Law imposed a fee on manufacturers and importers of branded prescription drugs and biologics based on their sales to United States government health programs. An aggregate annual fee of $3.0 billion was imposed on all covered entities for 2014 through 2016. The aggregate fee is allocated among applicable manufacturers and importers, including us, based on their relative sales to government health programs. The aggregate fee increased up to $4 billion for 2017, $4.1 billion for 2018, and is scheduled to be reduced to $2.8 billion for 2019 and thereafter. Beginning in 2013, the Healthcare Reform Law also imposed a new excise tax on many medical devices equal to 2.3% of the sales price, and excludes devices generally purchased by the general public at retail for individual use. However, with respect to the medical device excise tax, a two-year moratorium was imposed under the Consolidated Appropriations Act, 2016, suspending the imposition of the tax on device sales during the period beginning January 1, 2016 and ending December 31, 2017. On January 22, 2018, an additional two-year moratorium was imposed under Public Law No. 115-120, suspending the imposition of the tax on device sales during the period beginning January 1, 2018 and ending on December 31, 2019. Diagnostic division equipment that we manufacture or import into the United States may be subject to these taxes. In addition, the Prescription Drug User Fee Act, or PDUFA, first enacted in 1992, sets forth user fees that pharmaceutical and biological companies pay to the FDA for: certain applications for approvals of drugs and biologicals; the establishments where the products are made; and the products themselves. The fees under PDUFA cover a substantial portion of the FDA’s operating budget, and the measure also addresses aspects of the regulatory approval process, such as timing and procedures. PDUFA is subject to reauthorization by Congress every five years, and in December 2016, after a lengthy process involving significant industry and other stakeholder input, the FDA submitted its final recommendations to Congress for the sixth PDUFA reauthorization, which was signed into law in August 2017, and which covers fiscal years 2018 through 2022.

The marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. Federal, state and local governments in the United States have enacted and continue to consider additional legislation to limit the growth of healthcare costs, including the costs of prescription drugs. Existing and future legislation could limit payments for our existing products or for drug candidates that we are developing, including possibly permitting the federal government to negotiate prices directly with manufacturers. In addition, an increasing emphasis on managed care in the United States has increased and will continue to increase the pressure on pharmaceutical

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pricing. For a discussion of certain risks related to reimbursement and pricing, see Item 3 of this Part I, “Key Information — D. Risk Factors — Risks Relating to the Healthcare Industry — The implementation of the Healthcare Reform Law in the United States may adversely affect our business.”

Other Governmental Regulation

Our operations and many of the products that we manufacture or sell are subject to extensive regulation by numerous other governmental agencies, both within and outside the United States non-compliance with which could adversely affect our business, financial condition and results of operations. In the United States, apart from the agencies discussed above, our facilities, operations, employees, products (their manufacture, sale, import and export) and services are regulated by the Drug Enforcement Agency, the Environmental Protection Agency, the Occupational Health & Safety Administration, the Department of Agriculture, the Department of Labor, Customs and Border Protection, the Transportation Security Administration, the Department of Commerce, the Department of Treasury, the DOJ, the U.S. Office of Foreign Assets Control and others. State and local agencies also regulate our facilities, operations, employees, products and services within their respective states and localities. Government agencies outside the United States also regulate public health, product registration, manufacturing, environmental conditions, labor, exports, imports and other aspects of our global operations. For further discussion of the impact of regulation on our business, see Item 3 of this Part I, “Key Information — D. Risk Factors — Risks Relating to the Healthcare Industry — Certain of our business practices are subject to scrutiny by regulatory authorities, as well as to lawsuits brought by private citizens under federal and state laws. Failure to comply with applicable law or an adverse decision in lawsuits may result in adverse consequences to us.”

Item 4.A. UNRESOLVED STAFF COMMENTS

None.

Item 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS

The following is a review of our financial condition and results of operations as of December 31, 2018 and 2017, and for the three years ended December 31, 2018, and of the key factors that have affected or are expected to be likely to affect our ongoing and future operations. You should read the following discussion and analysis in conjunction with our audited consolidated financial statements and the accompanying notes included elsewhere in this annual report on Form 20-F.

Some of the information contained in this discussion, including information with respect to our plans and strategies for our business and our expected sources of financing, contain forward-looking statements that involve risk and uncertainties. You should read “Cautionary Statement Regarding Forward-Looking Statements” in this Part I for a discussion of the risks related to those statements. You should also read Item 3 of this Part I, “Key Information — D. Risk Factors” for a discussion of certain factors that may affect our business, financial condition and results of operations.

We have prepared our audited consolidated financial statements as of December 31, 2018 and 2017, and for the three years ended December 31, 2018 in accordance with IFRS, as issued by the IASB. The financial information and related discussion and analysis contained in this item are presented in euro except as otherwise specified. Unless otherwise specified the financial information analysis in this annual report on Form 20-F is based on our actual audited consolidated financial statements as of December 31, 2018 and 2017, and for the three years ended December 31, 2018.

See “Presentation of Financial and Other Information” in this Part I for further information on our presentation of financial information.

A. Operating Results.

Subsequent Events

The Shanghai RAAS Acquisition

On March 7, 2019, we entered into an Agreement for Assets Purchase by Share Issue with Shanghai RAAS, a leader in China’s plasma derivatives sector. Subject to regulatory approval, we will acquire 26.2% of the voting and economic rights in Shanghai RAAS, in exchange for a contribution of 45% of the economic rights and 40% of the voting rights in our U.S. subsidiary, Grifols Diagnostic Solutions (“GDS”). We will continue to hold 55% of the economic rights and 60% of the voting rights in GDS.

Upon consummation of the transaction, we will be the second largest shareholder in Shanghai RAAS. We will have the right to appoint three directors to the board of directors of Shanghai RAAS and Shanghai RAAS will have the right to appoint one director

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to the board of directors of GDS. Additionally, we will have a veto right on certain decisions such as those related to the issuance of shares, the disposal of assets, and decisions regarding mergers and modification of the articles of association.

Moreover, as part of the acquisition, we have entered into an Exclusive Strategic Alliance Agreement pursuant to which Shanghai RAAS will be the exclusive distributor of our bioscience and diagnostic products in China. In exchange for royalties, we will provide technological and know-how support to Shanghai RAAS in the bioscience and diagnostic fields. We will also provide engineering services to Shanghai RAAS in exchange for fees, and Shanghai RAAS committed to using GDS NAT technology throughout its network of 41 plasma collection centers.

We expect the transaction to close in the second half of 2019, pending approval by regulatory authorities.

Factors Affecting Our Financial Condition and Results of Operations

Price Controls

Certain healthcare products, including plasma derivative products, are subject to price controls in many of the markets where they are sold, including Spain and other countries in the European Union. The existence of price controls over these products has adversely affected in the past, and may continue to adversely affect, our ability to maintain or increase our prices and gross margins.

Plasma Supply Constraints

Plasma is the key raw material used in the production of plasma-derived products. Our ability to continue to increase our revenue depends substantially on increased access to plasma. We currently obtain our plasma from the United States primarily through our plasma collection centers and, to a much lesser extent, through agreements with third parties.

A continued increase in demand for plasma products could lead to industry supply constraints. In response, we and certain of our competitors and independent suppliers could open a number of new plasma collection centers.

We have 197 operating plasma collection centers located across the United States and have the rights to all plasma collected at an additional 24 plasma centers in the United States and 35 plasma centers in Germany. See “— Acquisitions — Acquisition and Sale of Haema AG and Biotest US Corporation” below. We have expanded our plasma collection network through a combination of organic growth by opening new plasma collection centers and acquisitions. Our acquisitions of SeraCare (now renamed Biomat USA) in 2002; PlasmaCare, Inc. (merged with Biomat USA in 2015) in 2006; eight plasma collection centers from a subsidiary of Baxter (now Takeda) in 2006; four plasma collection centers from Bio Medics, Inc. in 2007; and one plasma collection center from Amerihealth Plasma LLC in 2008 have given us reliable access to United States source plasma. Our acquisition of Talecris in June 2011 expanded our network by an additional 67 centers. In 2016, we purchased equity interests in the Interstate Blood Bank Group (a 49.19% equity interest in Interstate Blood Bank, Inc., a 48.97% equity interest in Bio-Blood Components, Inc. and a 48.90% equity interest in Plasma Biological Services, LLC), one of the main private and independent plasma suppliers in the United States, with the option to purchase the remaining 51%. In February 2017, we purchased six collection centers from Kedplasma LLC.

In 2018, our plasma collection centers obtained approximately 12 million liters of plasma (including specialty plasma required for the production of hyperimmunes and plasma acquired from third parties). We believe that our plasma requirements through 2019 will be met through: (i) plasma collected through our plasma collection centers, (ii) plasma collected through our Plasma Supply Agreement and (iii) plasma purchased from third-party suppliers pursuant to various plasma purchase agreements.

Acquisitions

Acquisition and Sale of Haema AG and Biotest US Corporation

In June 2018, we completed the acquisition of Haema AG, a German based pharmaceutical company that owns 35 collection centers throughout Germany, for a purchase price of $220 million on a debt free basis. In August 2018, we completed the acquisition of Biotest US Corporation, a U.S. based pharmaceutical company that owns 24 plasma collection centers, for a purchase price of $286 million. In December 2018, we sold our 100% stake in Haema AG and Biotest US Corporation to Scranton Enterprises B.V., one of our major shareholders and a related party, for $538 million. This acquisition and subsequent sale allowed us to reinforce our financial structure. We have an option to repurchase the shares of Haema AG and Biotest US Corporation from Scranton Enterprises B.V. exercisable at any time. Our Plasma Supply Agreement in place with Haema and Biotest has been extended for a 30-year period and we continue to operate the companies’ plasma centers.

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MedKeeper Investment

In January 26, 2018, we acquired the U.S. technology firm Goetech, LLC, based in Denver, Colorado, doing business as MedKeeper. This transaction, for a total of $98 million, included a 51% stake in the company and a call option for Grifols and put option for MedKeeper for the remaining 49% on the third anniversary of the deal. We hold a majority position on the board of directors. MedKeeper’s core business is the development and distribution of web and mobile-based platforms for hospital pharmacies that improve quality standards, productivity in the process, control systems and monitoring different preparations while increasing patient safety. This investment will enhance the activity of the Grifols Hospital division and it is part of the strategy to underpin this division into the U.S. market. The acquisition complements our Pharmatech line and enhances our presence in the U.S. market.

GigaGen Investment

In July 2017, we acquired a 43.96% equity interest in GigaGen Inc., or GigaGen, a pre-clinical biotherapeutics company, for $35 million. As part of this acquisition, we entered into a research and collaboration agreement with GigaGen whereby, in exchange for a collaboration fee of $15 million in the aggregate, GigaGen will commit to carry out research activities to develop recombinant plyclonal immunoglobulin therapies derived from human B cells for the treatment of human diseases.

Investment in Access Biologicals, LLC

On January 10, 2017, we acquired 49% of the voting rights in Access Biologicals for $51 million. We were also granted the option, exercisable in 2022, to purchase the remaining 51% of the voting rights of the company for a multiple of its earnings within a five-year timeframe. Access Biologicals is based in Vista, California and collects and manufactures an extensive biological product portfolio. It provides support for various markets such as in-vitro diagnostic manufacturing, biopharmaceutical, cell culture and diagnostic research & development.

The Hologic, Inc. Acquisition

On December 14, 2016, we entered into the Hologic Agreement with Hologic. The Hologic Transaction closed on January 31, 2017, at which time we paid a purchase price of $1.865 billion to Hologic. The agreement included activities related to the research, development and production of reagents and instruments based on NAT technology. Prior to the transaction, we and Hologic jointly operated this business, with Hologic responsible for research and development and manufacturing of the Procleix® blood screening products and Grifols responsible for their commercialization worldwide.

Investment in Singulex, Inc.

On May 13, 2016, we invested $50 million in Singulex, Inc., or Singulex, to acquire 20% of the common stock interest in Singulex. In connection with the investment, Singulex also granted us an exclusive worldwide license under certain intellectual property rights for the use and sale of certain products and services for blood donor and plasma screening, which will help to further ensure the safety of our blood and plasma products.

Singulex is the developer of the Single Molecule Counting (SMC™) technology for clinical diagnostic and scientific discovery. This technology enables the detection of disease biomarkers that were previously undetectable. Singulex is developing a fully-automated in vitro diagnostics system that will allow the company to bring its technology to hospitals and laboratories worldwide. Singulex provides clinical laboratory testing services to enhance the early detection of cardiac and vascular disorders and sells immunoassay tests and services.

Investment in the Interstate Blood Bank Group

On April 11, 2016, Grifols Worldwide Operations Limited acquired a 49.19% equity interest in Interstate Blood Bank, Inc., a 48.97% equity interest in Bio-Blood Components, Inc., and a 48.90% equity interest in Plasma Biological Services, LLC, collectively referred to herein as the “IBBI Group”, for $100 million. We were also granted the option, exercisable in 2019, to purchase the remaining 51% of the voting rights of the IBBI Group for $100 million, and we paid an additional $10 million for this option. The transactions with the IBBI Group closed on May 11, 2016. IBBI Group’s principal business is the collection of plasma for the plasma fractionation industry.

Acquisition of Progenika

On March 3, 2016, we announced the acquisition of shares representing 32.93% of the economic and voting rights of Progenika Biopharma, S.A., or Progenika, for a total amount of €25 million. The acquisition involved the execution of the put and call options that certain shareholders of Progenika and Grifols granted to each other on February 27, 2013. 50% of the purchase price was

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paid in exchange for 876,777 non-voting class B shares of Grifols, with a face value of €0.05 per share. The remaining 50% of the purchase price was paid in cash.

Between 2016 and 2018 we executed the call options granted to us by certain shareholders of Progenika. As a result, Grifols has increased its stake in Progenika to 99.99% of the share capital as of December 31, 2018.

AlbaJuna Therapeutics Investment

In January 2016, we acquired 30% of the equity of AlbaJuna Therapeutics S.L. for €3.75 million in cash to fund the development and manufacturing of therapeutic antibodies against HIV. The initial investment will be increased upon the achievement of agreed-upon developmental milestones.

In February 2019, we subscribed for a capital increase in AlbaJuna Therapeutics S.L. for an amount of €3.75 million. As a result we now hold 49% of the share capital of the company.

AlbaJuna Therapeutics, a spin-off from the AIDS Research Institute, IrsiCaixa, promoted jointly by Obra Social “La Caixa” Foundation and the Department of Health of the Generalitat de Catalunya, was established to promote the pre-clinical and clinical development of monoclonal antibodies that neutralize the action of HIV in the body while they increase the activity of the natural killer cells that have the task of destroying infected cells.

Kiro Grifols Acquisition and Joint Venture

In September 2014, Grifols purchased 50% of Kiro Grifols, S.L (formerly Kiro Robotics, S.L.) for €21 million. In July 2017, Grifols acquired an additional 40% of Kiro Grifols, S.L for €12.8 million. As a result, Grifols now owns 90% of the voting and economic rights of Kiro Grifols, S.L. The remaining 10% will continue to be held by Socios Fundadores Kiro, S.L., a company wholly owned by cooperatives of the Mondragon Corporation. While executing the purchase agreement for the additional 40% stake in Kiro Grifols, S.L., together with the remaining shareholder of Kiro Grifols, S.L., we also signed an amendment to the then existing shareholders agreement, whereby certain provisions governing the management of the company, the distribution of dividends and the transfer of shares (i.e., 4 year lock-up period, preferential purchase rights, drag and tag along rights) were rendered ineffective as of that time, and Mondragon Corporation maintained the right to appoint one member of the board of directors of Kiro Grifols, S.L.

Grifols also entered into a joint venture & shareholders’ agreement (the “Joint Venture Agreement”) with the partners of Kiro Grifols, S.L: Mondragon Innovacion S.P.E, S.A.; Mondragon Assembly, S.Coop. and Agrupación de Fundición y Utillaje, S.Coop. This agreement governs, among other matters, the capital increase subscribed by Grifols and the managing and governing bodies of Kiro Grifols S.L, including the board of directors and any other internal managing and governing bodies.

Kiro Grifols, S.L, a spin-off of Mondragon Health, a strategic unit of the Mondragon Corporation, is a Spanish technological company that develops, manufactures and sells machinery and equipment designed to automate or control critical hospital processes, such as dose dispensing in hospital pharmacy and clinical diagnostic services. It also develops technologies designed to improve the efficiency, safety and quality of hospital processes, such as the Kiro Oncology robot, which automates the preparation of intravenous medication for chemotherapy to reduce the risk that health professionals will come into contact with hazardous products.

Other Factors

Our financial and operating prospects can also be significantly affected by a number of other internal and external factors, such as unfavorable changes in governmental regulation or interpretation, increased competition, the inability to hire or retain qualified personnel necessary to sustain planned growth, the loss of key senior managers, problems in developing some of the international operations and lack of sufficient capital, among others.

Operating Results

Overview

The subsequent discussion and analysis provides information that our management believes is relevant to an assessment and understanding of our consolidated results of operations. You are encouraged to read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and the related notes included elsewhere in this annual report on Form 20-F.

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Year Ended December 31, 2018 Compared to Year Ended December 31, 2017

The following discussion and analysis contains information regarding our results of operations for the year ended December 31, 2018, as compared to the year ended December 31, 2017:

|  | Year Ended December 31, |  | Change |
|  | 2018 |  | 2017 |  | € |  | % |
|  | (in thousands of euros, except for percentages) |
Continuing Operations |  |  |  |  |  |  |  |  |
Net revenue |  | 4,486,724 |  | 4,318,073 |  | 168,651 |  | 3.9 | %
Cost of sales |  | (2,437,164 | ) | (2,166,062 | ) | (271,102 | ) | 12.5 | %
Gross profit |  | 2,049,560 |  | 2,152,011 |  | (102,451 | ) | 4.8 | %
Research and development |  | (240,661 | ) | (288,320 | ) | 47,659 |  | (16.5 | )%
Selling, general and administration expenses |  | (814,775 | ) | (860,348 | ) | 45,573 |  | (5.3 | )%
Operating expenses |  | (1,055,436 | ) | (1,148,668 | ) | 93,232 |  | (8.1 | )%
Operating result |  | 994,124 |  | 1,003,343 |  | (9,219 | ) | (0.9 | )%
Finance income |  | 13,995 |  | 9,678 |  | 4,317 |  | 44.6 | %
Finance costs |  | (293,273 | ) | (263,344 | ) | (29,929 | ) | 11.3 | %
Change in fair value of financial instruments |  | — |  | (3,752 | ) | — |  | — | %
Impairment and gains/(losses) on disposal of financial instruments |  | 30,280 |  | (18,844 | ) | 49,124 |  | (260.7 | )%
Exchange differences |  | (8,246 | ) | (11,472 | ) | 3,226 |  | (28.1 | )%
Finance result |  | (257,244 | ) | (287,734 | ) | 30,490 |  | (10.6 | )%
Share of (losses) of equity accounted investees |  | (11,038 | ) | (19,887 | ) | 8,849 |  | (44.5 | )%
Profit before income tax |  | 725,842 |  | 695,722 |  | (33,120 | ) | (4.7 | )%
Income tax expense |  | (131,436 | ) | (34,408 | ) | (97,028 | ) | 281.9 | %
Profit after income tax from continuing operations |  | 594,406 |  | 661,314 |  | (66,908 | ) | 10.1 | %
Consolidated profit for the year |  | 594,406 |  | 661,314 |  | (66,908 | ) | 10.1 | %

Net Revenue

Net revenue is calculated by subtracting certain chargebacks, cash discounts, volume rebates, Medicare and Medicaid discounts and other discounts from our gross revenue. See Note 23 to our audited consolidated financial statements included in this annual report on Form 20-F.

Net revenue increased by €168.6 million from €4.3 billion in 2017 to €4.5 billion in 2018. This 3.9% (9.2% at constant currency) net revenue increase is the result of growth in revenue in all of our divisions and geographic regions where we operate at constant currency.

The following table reflects a summary of net revenue by each of our divisions for 2018, as compared to 2017:

Summary of Net Revenue by Division |  | Year ended December 31, 2018 |  | % of total net revenue |  | Year ended December 31, 2017 |  | % of total net revenue |  | % var |  | % var CC(1) |
|  | (in thousands of euros, except for percentages) |
Bioscience |  | 3,516,704 |  | 78.4 | % | 3,429,785 |  | 79.4 | % | 2.5 | % | 8.0 | %
Diagnostic |  | 702,265 |  | 15.6 | % | 732,369 |  | 17.0 | % | (4.1 | )% | 0.7 | %
Hospital |  | 119,454 |  | 2.7 | % | 105,649 |  | 2.4 | % | 13.1 | % | 16.0 | %
Bio Supplies |  | 167,004 |  | 3.7 | % | 66,791 |  | 1.6 | % | 150.0 | % | 154.9 | %
Others |  | 22,451 |  | 0.5 | % | 18,263 |  | 0.4 | % | 22.9 | % | 29.6 | %
Intersegments |  | (41,154 | ) | (0.9 | )% | (34,784 | ) | (0.8 | )% | 18.3 | % | 24.8 | %
Total |  | 4,486,724 |  | 100.0 | % | 4,318,073 |  | 100.0 | % | 3.9 | % | 9.2 | %

(1) Net revenue variance in constant currency is determined by comparing adjusted current period net revenue, calculated using prior period monthly average exchange rates, to the prior period net revenue. See “Presentation of Financial and Other Information.”

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Bioscience. Net revenue for the Bioscience division increased by 2.5% (8.0% at constant currency) from €3.4 billion in 2017 to €3.5 billion in 2018. This increase was primarily due to robust sales of the main plasma proteins — immunoglobulin, albumin and alpha-1 antityspsin. Sales growth of these plasma proteins, together with certain specialty immunoglobulins, offset the decline in sales of Factor VIII. The renewal processes of certain licenses in China were unexpectedly delayed in the last quarter of 2018, impacting sales.

The demand for immunoglobulin remains strong in our core markets, especially in the U.S. and EU countries led by Spain, Germany and the United Kingdom. Sales also grew in Turkey, Brazil and Australia, where, in addition to primary immunodeficiencies, immunoglobulins are also used to treat secondary immunodeficiencies and neurological diseases like chronic inflammatory demyelinating polyneuropathy (CIPD), a market segment led by us. We achieved double-digit growth in immunoglobulin sales in 2018 and plan on launching a 20% subcutaneous immunoglobulin in the second half of 2019 that will increase our market share.

Albumin sales grew markedly in the U.S. and in several European countries including Italy, the United Kingdom and Turkey. China is a market with significant underlying demand and remains a core focus in Grifols’ global sales strategy.

We continue to lead in alpha-1 antitrypsin sales. Market penetration of this plasma protein grew in the U.S. and main EU markets thanks to effective sales strategies and an increase in the number of diagnosed patients. The FDA recently approved our new genetic test for alpha-1 deficiency and Prolastin®-C Liquid. This liquid formulation enhances Grifols’ respiratory franchise and offers a new treatment alternative for patients.

Sales of Factor VIII dropped notably in 2018 due to their declining use to treat patients with inhibitors. The Company positions Factor VIII as the best treatment for hemophilia A patients, concentrating its efforts in the U.S. and emerging markets.

We continue to promote specialty proteins to improve our differential product portfolio. Two new formulations helped boost sales in the specialty hyperimmunoglobulins segment: an anti-rabies immunoglobulin (HyperRAB®), with twice the potency (300 IU/ml) of currently available rabies immunoglobulin options; and GamaSTAN®, an intramuscular immunoglobulin for patients exposed to hepatitis A or measles. Both products earned FDA approval in the first half of 2018.

Diagnostic. Diagnostic division net revenue decreased by 4.1% (increased by 0.7% at constant currency) from €732.4 million in 2017 to €702.3 million in 2018. Grifols is the worldwide leader in transfusional diagnostics, the division’s main engine for growth in 2018. This business area includes NAT donor-screening diagnostics (Procleix® NAT Solutions), blood-typing solutions and the production of antigens for immunoassays.

Higher NAT solutions sales were primarily driven by a greater volume of plasma donations and increased use of the Zika-virus screening test (Procleix® Zika Virus). The Company also broadened its product portfolio with newly FDA-approved reagents to detect HIV, hepatitis B and C virus (Procleix® Ultrio Elite), and the West Nile virus (Procleix® WNV), among others.

Outside of the U.S., sales of this innovative technology were also strong in Latin America, Poland and Indonesia. The Company continues its efforts to raise its presence in the Middle East.

The line of blood-typing products contributed to the division’s overall performance, particularly in the U.S., core markets in Latin America, Europe and Saudi Arabia.

European sales of Erytra Eflexis® increased, with more than 200 units sold since its launch in June 2017. We had already introduced the product in the U.S. in 2019 earning FDA approval. In 2018, a new line of conventional antiserums earned FDA approval and was released, broadening the product portfolio.

The Company further consolidated its line of antigens to produce immunoassays in 2018.

Revenues in specialty diagnostics remained stable and are expected to rise as Grifols widens its clinical diagnostics offerings. In 2018, the FDA approved two diagnostic products designed to detect autoimmune diseases. Both were developed by AESKU and distributed by Grifols on the Helios platform.

The Company is committed to developing new diagnostic tests for personalized medicine through Progenika Biopharma. Its molecular diagnostic ID CORE XT for genotyping blood groups recently earned FDA approval.

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Hospital. Net revenue from the Hospital division increased by 13.1% (16.0% at constant currency) from €105.6 million in 2017 to €119.5 million in 2018. Sales of all business lines grew, especially the Pharmatech line in the U.S. market. A key strategic area for future growth, this business line offers integral services to hospital pharmacies for IV compounding, including MedKeeper and Kiro Oncology products. The division also reported stronger IV solutions sales, particularly the physiological saline solution manufactured in the Murcia (Spain) plant. The product was introduced in the U.S. market after obtaining FDA approval and is also used in Grifols’ own network of plasma centers. As evidenced by the division’s growth, we have bolstered our presence in the United States and executed various aspects of the group’s global expansion strategy. Sales of the Nutrition and Medical Devices lines also increased, accompanied by an increase in third-party manufacturing services.

Bio Supplies. The division records sales of biological products for non-therapeutic use and other biological products, as well as those related to the fractionation and purification agreements signed with Kedrion and third-party plasma sales channeled through Haema and Biotest.

Net revenue from Bio Supplies increased by 150.0% (154.9% at constant currency) from €66.8 million in 2017 to €167.0 million in 2018 mainly as a result of third-party plasma sales channeled through Haema and Biotest, which represented €80.3 million in 2018.

Others. Net revenue from Others increased by 22.9% (29.6% at constant currency) from €18.2 million in 2017 to €22.4 million in 2018.

The following table reflects a summary of net revenue by each of our geographic regions for 2018 as compared to 2017:

Summary of Net Revenue by Region |  | Year ended December 31, 2018 |  | % of total net revenue |  | Year ended December 31, 2017 |  | % of total net revenue |  | % var |  | % var CC(1) |
|  | (in thousands of euros, except for percentages) |
European Union(2) |  | 800,186 |  | 17.8 |  | 686,983 |  | 15.9 |  | 16.5 |  | 16.7 |
United States and Canada |  | 2,974,429 |  | 66.3 |  | 2,896,505 |  | 67.1 |  | 2.7 |  | 8.7 |
Rest of the World |  | 712,021 |  | 15.9 |  | 734,585 |  | 17.0 |  | (3.1 | ) | 4.0 |
Total |  | 4,486,724 |  | 100.0 |  | 4,318,073 |  | 100.0 |  | 3.9 |  | 9.2 |

(1) Net revenue variance in constant currency is determined by comparing adjusted current period net revenue, calculated using prior period monthly average exchange rates, to the prior period net revenue. See “Presentation of Financial and Other Information.”

(2) Net revenue earned in the European Union includes net revenue earned in Spain.

We believe that our ongoing internationalization has helped to improve our sales performance. We have seen a stabilization in the proportion of net revenue to total net revenue accounted for by Spain, as we continue to focus on increasing sales in regions less affected by austerity measures, with shorter payment periods and better margins. In 2018, 94.1% of net revenue, or €4.2 billion, was derived from countries outside of Spain. International expansion remains a strategic priority to stimulate the Company’s organic growth, although each division focuses on specific markets and distinct strategies to optimize sales.

Revenues in the U.S. and Canada grew by 2.7% (8.7% at constant currency) in 2018 to €2,974.4 million. Meanwhile, sales in the European Union rose by 16.5% (16.7% at constant currency) to €800.2 million, headed by growth in countries like Spain, Germany, the United Kingdom and France. Sales in Rest of the World slightly contracted, registering a 3.1% (increased by 4.0% at constant currency) decrease to €712.0 million.

Cost of sales

Cost of sales increased by 12.5% from €2.2 billion in 2017 to €2.4 billion in 2018. Cost of sales as a percentage of net revenue increased to 54.3% compared to 50.2% in 2017. This was mainly due to the impact of higher plasma procurement costs relative to the Company’s efforts, both organic and inorganic, to increase its plasma supply and meet the solid demand of its plasma-derived therapies.

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Gross Profit

The decrease in gross profit margin from 49.8% of net revenue in 2017 to 45.7% in 2018 was mainly due to higher plasma procurement costs and also affected by temporary albumin sales restriction in China, the geographic mix of Factor VIII sales, tender volatility, and the product mix of the Diagnostic division, which reported stronger demand for antigens used to produce immunoassays and transfusion-medicine diagnostic instruments.

Research and development

Research and development spending decreased from €288.3 million (6.7% of net revenue) in 2017 to €240.7 million (5.4% of net revenue) in 2018. We decided to increase our research and development investment in certain projects, specifically those related to albumin, in light of the positive results of the AMBAR trial and trials on liver diseases (PRECIOSA and APACHE studies). See Item 4 of this Part I, “Information on the Company — B. Business Overview — Research and Development” for additional details.

Selling, general and administration expenses

Selling, general and administration expenses decreased by 5.3% from €860.3 million in 2017 to €814.8 million in 2018 mainly as a result of optimization projects.

Finance result

Finance result decreased by 10.6% from €287.7 million in 2017 to €257.2 million in 2018. This decrease was primarily a result of the impairment and gains/losses on disposal of financial. Finance results also includes the amortization of capitalized costs related to our debt.

Income tax expense

In 2018, we had a profit before income tax of €725.8 million and income tax expense of €131.4 million, which represents a tax rate of 18.1%. Our effective tax rate decreased from 27.3% in 2017, excluding the non-recurring impact of the U.S tax reform and the tax effect of the specific impairment of Aradigm’s assets and of cost resulting from the acquisition and subsequent integration of the NAT technology donor-screening business, basically due to a change of country mix-in profits.

Year Ended December 31, 2017 Compared to Year Ended December 31, 2016

The following discussion and analysis contains information regarding our results of operations for the year ended December 31, 2017, as compared to the year ended December 31, 2016:

|  | Year Ended December 31, |  | Change |
|  | 2017 |  | 2016 |  | € |  | % |
|  | (in thousands of euros, except for percentages) |
Continuing Operations |  |  |  |  |  |  |  |  |
Net revenue |  | 4,318,073 |  | 4,049,830 |  | 268,243 |  | 6.6 | %
Cost of sales |  | (2,166,062 | ) | (2,137,539 | ) | (28,523 | ) | 1.3 | %
Gross profit |  | 2,152,011 |  | 1,912,291 |  | 239,720 |  | 12.5 | %
Research and development |  | (288,320 | ) | (197,617 | ) | (90,703 | ) | 45.9 |
Selling, general and administration expenses |  | (860,348 | ) | (775,266 | ) | (85,082 | ) | 10.9 | %
Operating expenses |  | (1,148,668 | ) | (972,883 | ) | (175,785 | ) | 18.1 | %
Operating result |  | 1,003,343 |  | 939,408 |  | 63,935 |  | 6.8 | %
Finance income |  | 9,678 |  | 9,934 |  | (256 | ) | (2.6 | )%
Finance costs |  | (263,344 | ) | (244,829 | ) | (18,515 | ) | 7.6 | %
Change in fair value of financial instruments |  | (3,752 | ) | (7,610 | ) | 3,858 |  | 50.7 | %
Impairment and gains/(losses) on disposal of financial instruments |  | (18,844 | ) | — |  | — |  | — |
Exchange differences |  | (11,472 | ) | 8,916 |  | (20,388 | ) | (228.7 | )%
Finance result |  | (287,734 | ) | (233,589 | ) | (54,145 | ) | 23.2 | %
Share of (losses) of equity accounted investees |  | (19,887 | ) | 6,933 |  | (26,820 | ) | (386.8 | )%
Profit before income tax |  | 695,722 |  | 712,752 |  | (17,030 | ) | (2.4 | )%
Income tax expense |  | (34,408 | ) | (168,209 | ) | (133,801 | ) | (79.5 | )%
Profit after income tax from continuing operations |  | 661,314 |  | 544,543 |  | 116,771 |  | 21.4 | %
Consolidated profit for the year |  | 661,314 |  | 544,543 |  | 116,771 |  | 21.4 | %

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The consolidated profit for 2017 included non-recurring items associated with the impact of the U.S. tax reform and the specific impairment of Aradigm’s assets. See to our audited consolidated financial statements included in this annual report on Form 20-F for more detail.

Net Revenue

Net revenue is calculated by subtracting certain chargebacks, cash discounts, volume rebates, Medicare and Medicaid discounts and other discounts from our gross revenue. See Note 23 to our audited consolidated financial statements included in this annual report on Form 20-F.

Net revenue increased by €268 million from €4.0 billion in 2016 to €4.3 billion in 2017. This 6.6% (7.2% at constant currency) net revenue increase is the result of a significant upturn in revenues in all of our divisions and regions where we operate.

The following table reflects a summary of net revenue by each of our divisions for 2017, as compared to 2016:

Summary of Net Revenue by Division |  | Year ended December 31, 2017 |  | % of total net revenue |  | Year ended December 31, 2016(2) |  | % of total net revenue |  | % var |  | % var CC(1) |
|  | (in thousands of euros, except for percentages) |
Bioscience |  | 3,429,785 |  | 79.4 | % | 3,195,424 |  | 78.9 | % | 7.3 | % | 7.9 | %
Diagnostic |  | 732,369 |  | 17.0 | % | 691,701 |  | 17.1 | % | 5.9 | % | 6.8 | %
Hospital |  | 105,649 |  | 2.4 | % | 102,251 |  | 2.5 | % | 3.3 | % | 3.3 | %
Bio Supplies |  | 66,791 |  | 1.6 | % | 57,239 |  | 1.4 | % | 16.7 | % | 18.1 | %
Others |  | 18,263 |  | 0.4 | % | 34,601 |  | 0.9 | % | (47.2 | )% | (45.4 | )%
Intersegments |  | (34,784 | ) | (0.8 | )% | (31,386 | ) | (0.8 | )% | 10.8 | % | 11.3 | %
Total |  | 4,318,073 |  | 100.0 | % | 4,049,830 |  | 100.0 | % | 6.6 | % | 7.2 | %

(1) Net revenue variance in constant currency is determined by comparing adjusted current period net revenue, calculated using prior period monthly average exchange rates, to the prior period net revenue. See “Presentation of Financial and Other Information.”

(2) Comparable revenues considering intersegment sales and the reclassification of the biological products for non-therapeutic use sales that are reported as Bio Supplies division sales from January 2017.

Bioscience. Net revenue for the Bioscience division increased by 7.3% (7.9% at constant currency) from €3.2 billion in 2016 to €3.4 billion in 2017. This increase was primarily due to volume growth for our main plasma products, with a moderate increase in pricing. The geographic mix of our sales had a negative impact on revenues due to higher sales volumes of blood clotting factors in more competitive price environments, subject to public tenders in certain emerging markets.

· Immunoglobulin volume sales were robust throughout the year, especially in the United States and the main European markets, with growing contributions by specific countries such as Australia and Turkey. Growing global demand for this plasma protein to treat neurological conditions such as chronic inflammatory demyelinating polyneuropathy (CIDP) was evident in core geographies like the United States, where Grifols is the market leader. We also continue to promote diagnostic programs to identify patients with immunodeficiencies that could benefit from immunoglobulin therapies.

· Sales of Alpha-1 antitrypsin continued to grow. Higher rates of diagnosis of alpha-1 antitrypsin deficiency, particularly in the United States, Canada and several European countries, drove higher sales of this protein. Demand also grew in certain Latin American countries, although more incipiently.

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· Sales of albumin, continued to drive the division’s growth, especially in China, the European Union and Latin America. Brazil, Indonesia and several Middle Eastern countries also saw an increase in sales attributable to the division’s commercial efforts.

· Sales volume of factor VIII continued to grow in a competitive price environment subject to public tenders in certain emerging markets.

· Specialty proteins also drove growth. Hyperimmune immunoglobulin sales were particularly strong. We also signed an agreement with Spain’s Ministry of Health to supply tetanus and diphtheria vaccines beginning in April 2017. We market these vaccines pursuant to an agreement with MassBiologics of the University of Massachusetts Medical School in the U.S.

Diagnostic. Diagnostic division net revenue increased by 5.9% (6.8% at constant currency) from €692 million in 2016 to €732 million in 2017. This increase was mainly due to the transfusion medicine business, the division’s main growth driver, as described below.

· Sales of NAT donor screening systems (Procleix® NAT Solutions), used to screen blood and plasma donations, were the division’s leading source of revenues. Additional revenue streams included sales of the Zika virus blood screening tests in the United States and greater market penetration in the Asia Pacific region, particularly in Japan, China, Saudi Arabia, Israel and Singapore.

· Sales of antigens used to manufacture diagnostic immunoassays, marketed as part of the joint business agreement with Ortho Clinical Diagnostics continued to increase.

· The blood typing and immunohematology line also contributed to the division’s revenues. Sales of blood typing reagents were exceptionally strong in China as a result of commercial efforts implemented in this key region, as well as in the U.S., a market where we believe we have substantial growth potential. This upward trend was also seen in certain European countries, including Hungary, Italy, Switzerland, Spain and France. Geographic expansion is one of the main drivers of growth in this division.

Specialty diagnostics revenues remained stable, and will benefit as the division progressively expands its clinical diagnostics product portfolio. We continue to concentrate our efforts on developing new diagnostic tests for personalized medicine through Progenika Biopharma. It has also strengthened the commercialization of Grifols’ hemostasis line thanks to an exclusive global distribution agreement with Beckman Coulter.

Hospital. Net revenue from the Hospital division increased by 3.3% (3.3% at constant currency) from €102.3 million in 2016 to €105.6 million in 2017. We continue to promote the internationalization of the division. In 2017, 32% of net revenue was generated outside Spain, as compared to 29% in 2016. Sales are growing in Spain, the United States and Latin America as a result of our global expansion efforts by area of specialization, Pharmatech, which includes Hospital Logistics and i.v. Tools, and the Intravenous Therapies and the nutrition lines were the main drivers of growth. There was notable growth in the third-party manufacturing business line from new contracts in the U.S.

Bio Supplies. As of January 2017, the Bio Supplies division includes revenues previously included in Raw Materials. The division records sales of biological products for non-therapeutic use and other biological products, as well as those related to the fractionation and purification agreements signed with Kedrion.

Net revenue from Bio Supplies increased by 16.7% (18.1% at constant currency) from €57.2 million in 2016 to €66.8 million in 2017 mainly as a result of Kedrion related revenues and sales of biological products for non-therapeutic use.

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The following table reflects a summary of net revenue by each of our geographic regions for 2017 as compared to 2016:

Summary of Net Revenue by Region |  | Year ended December 31, 2017 |  | % of total net revenue |  | Year ended December 31, 2016 (3) |  | % of total net revenue |  | % var |  | % var CC(1) |
|  | (in thousands of euros, except for percentages) |
European Union(2) |  | 686,983 |  | 15.9 |  | 651,496 |  | 16.1 |  | 5.4 |  | 5.9 |
United States and Canada |  | 2,896,505 |  | 67.1 |  | 2,707,579 |  | 66.9 |  | 7.0 |  | 7.7 |
Rest of the World |  | 734,585 |  | 17.0 |  | 690,755 |  | 17.0 |  | 6.3 |  | 6.9 |
Total |  | 4,318,073 |  | 100.0 |  | 4,049,830 |  | 100.0 |  | 6.6 |  | 7.2 |

(1) Net revenue variance in constant currency is determined by comparing adjusted current period net revenue, calculated using prior period monthly average exchange rates, to the prior period net revenue. See “Presentation of Financial and Other Information.”

(2) Net revenue earned in the European Union includes net revenue earned in Spain.

(3) Comparable considering the new divisional structure that allocates “Raw Materials and Others” by region.

We believe that our ongoing internationalization has helped to improve our sales performance. We have seen a gradual reduction in the proportion of net revenue to total net revenue accounted for by Spain, as we continue to focus on increasing sales in regions less affected by austerity measures, with shorter payment periods and better margins. In 2017, 94% of net revenue, or €4.1 billion, was derived from countries outside of Spain. International expansion remains a strategic priority to stimulate the Company’s organic growth, although each division focuses on specific markets and distinct strategies to optimize sales.

The United States has become a core market for the three main divisions. Revenues in the U.S. and Canada grew by 7.0% (7.7% at constant currency) in 2017 to €2,896.5 million. Meanwhile, sales in the European Union rose by 5.4% (5.9% at constant currency) to €687 million, headed by growth in countries like Spain, Germany, the United Kingdom and France. Sales in Rest of the World also expanded, registering a 6.3% (6.9% cc) increase to €734.6 million. Especially noteworthy were the positive sales trends in China and Australia, which led the Asia Pacific region; growth in Latin America, especially Brazil; and the gradual market penetration in Turkey and the Middle East, including Saudi Arabia and Israel.

Cost of sales

Cost of sales increased by 1.3% from €2.1 billion in 2016 to €2.2 billion in 2017. Cost of sales as a percentage of net revenue improved to 50.2% compared to 52.8% in 2016. This was mainly due to the impact of the NAT donor-screening business acquired in January 2017 offset by the higher costs in the cost of sales as a the result of the investment plan to open new plasma collection centers.

Gross Profit

The increase in gross profit margin from 47.2% of net revenue in 2016 to 49.8% in 2017 was mainly due to the impact of the NAT donor-screening business acquired in January 2017 offset by the higher costs as a result of the investment plan to open new plasma collection centers.

Research and development

Research and development spending increased from €197.6 million (4.9% of net revenue) in 2016 to €288.3 million (6.7% of net revenue) in 2017. Excluding the specific impact of the impairment of Aradigm’s assets, research and development expenses comprised €223.7 million euros (5.2% of net revenue), 13.2% higher than in 2016. Our spending was focused on strengthening our pipeline, including in-house and external investments in research. See Item 4 of this Part I, “Information on the Company — B. Business Overview — Research and Development” for additional details.

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Selling, general and administration expenses

Selling, general and administration expenses increased by 11.0% from €775.3 million in 2016 to €860.3 million in 2017 mainly as a result of expenses relating to the integration of the NAT technology donor-screening business acquired in January 2017. Excluding these integration expenses, selling, general and administration expenses increased by 8.3% year-over-year, explained by the activity growth in all divisions and the NAT donor-screening business acquired in January 2017, and comprised 19.4% of net revenue, compared to 19.1% in 2016.

Finance result

Finance result increased by 23.2% from €233.6 million in 2016 to €287.7 million in 2017. This increase was primarily a result of the higher levels of debt assumed after acquiring a portion of the NAT technology donor-screening business in January 2017, and from the specific impairment of Aradigm’s assets. See Note 11 to our audited consolidated financial statements included in this annual report on Form 20-F for more detail. Excluding the impacts of these specific events, the finance result would have been €269.3 million or 15.3% higher than in 2016. Finance result also includes the amortization of capitalized costs related to our debt.

Income tax expense

In 2017, we had a profit before income tax of €695.7 million and income tax expense of €34.4 million, which represents a tax rate of 4.9%. The U.S. corporate tax reform approved on December 22, 2017 required Grifols to recognize non-recurring income that significantly affected our tax expense reported for 2017. The reduction from 35% to 21% on the U.S. federal corporate income tax rate (effective starting January 1, 2018) required a revaluation of Grifols U.S. deferred tax assets and liabilities. The net positive effect on the group’s 2017 results was €171.6 million. Excluding the non-recurring impact of the U.S. tax reform and the tax effect of the specific impairment of Aradigm’s assets and of costs resulting from the acquisition and subsequent integration of the NAT technology donor-screening business, the effective tax rate was 27.3%, compared to an effective tax rate of 23.6% in 2016.

Regulation

For detailed information regarding the regulations applicable to our business, see Item 4 of this Part I, “Information on the Company — E. Regulatory Matters.”

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Inflation

We historically have not been affected materially by inflation in our core geographies.

B. Liquidity and Capital Resources

Our principal liquidity and capital requirements consist of costs and expenses relating to the operation of our business, capital expenditures for existing and new operations and debt service requirements relating to our existing and future debt. Historically, we have financed our liquidity and capital requirements through internally generated cash flows, mainly attributable to revenue and debt financings. As of December 31, 2018, our cash and cash equivalents totaled €886.5 million. In addition, as of December 31, 2018, we had the equivalent of approximately €380 million available under our debt agreements, including the equivalent of approximately €250 million available as Revolving Loans under our New Credit Facilities.

We expect our cash flows from operations combined with our cash balances and availability under the Revolving Loans from the New Credit Facilities and other bank debt to provide sufficient liquidity to fund our current obligations, projected working capital requirements and capital expenditures for at least the next twelve months. Currently, we do not generate significant cash in any country that might have restrictions for funds repatriation, and we estimate that the existing cash located in Ireland, Spain and the United States, along with the cash generated from operations, will be sufficient to meet future cash needs in key countries.

Historical Cash Flows

Below are our consolidated statements of cash flow for the years ended December 31, 2018, 2017 and 2016, prepared under IFRS IASB.

Statements of Cash Flows
For the Years Ended December 31, 2018, 2017 and 2016

|  | Year Ended December 31, |
|  | 2018 |  | 2017 |  | 2016 |
|  | (in thousands of euros) |
Cash flows from operating activities |  |  |  |  |  |  |
Profit before tax |  | 725,842 |  | 695,722 |  | 712,752 |
Adjustments for: |  | 454,378 |  | 556,792 |  | 391,986 |
Amortization and depreciation |  | 228,609 |  | 215,490 |  | 201,869 |
Other adjustments: |  | 225,769 |  | 341,302 |  | 190,117 |
(Profit)/losses on equity accounted investments |  | 11,038 |  | 19,888 |  | (6,933 | )
Impairment of assets and net provision charges |  | (23,657 | ) | 66,047 |  | (23,079 | )
(Profit)/losses on disposal of fixed assets |  | (6,700 | ) | 1,551 |  | (2,987 | )
Government grants taken to income |  | (1,166 | ) | (286 | ) | (1,681 | )
Finance cost/(income) |  | 232,962 |  | 263,657 |  | 236,034 |
Other adjustments |  | 13,292 |  | (9,555 | ) | (11,237 | )
Changes in operating assets and liabilities |  | (112,639 | ) | (65,800 | ) | (164,319 | )
Change in inventories |  | (231,670 | ) | (165,508 | ) | (173,003 | )
Change in trade and other receivables |  | (13,141 | ) | 80,112 |  | (25,180 | )
Change in current financial assets and other current assets |  | (3,092 | ) | (2,691 | ) | (2,610 | )
Change in current trade and other payables |  | 135,264 |  | 22,287 |  | (36,474 | )
Other cash flows from/(used in) operating activities |  | (330,153 | ) | (344,968 | ) | (387,141 | )
Interest paid |  | (225,146 | ) | (207,079 | ) | (180,497 | )
Interest recovered |  | 6,862 |  | 9,492 |  | 8,685 |
Income tax (paid)/received |  | (111,585 | ) | (147,015 | ) | (215,329 | )
Other recovered (paid) |  | (284 | ) | (366 | ) | — |
Net cash from operating activities |  | 737,428 |  | 841,746 |  | 553,278 |
Cash flows from/(used in) investing activities |  |  |  |  |  |  |
Payments for investments |  | (852,536 | ) | (2,209,667 | ) | (509,078 | )
Group companies and business units |  | (524,081 | ) | (1,857,210 | ) | (202,727 | )
Property, plant and equipment and intangible assets |  | (307,722 | ) | (322,973 | ) | (292,690 | )
Property, plant and equipment |  | (231,983 | ) | (251,507 | ) | (249,416 | )
Intangible assets |  | (75,739 | ) | (71,466 | ) | (43,274 | )
Other financial assets |  | (20,733 | ) | (29,484 | ) | (13,661 | )
Proceeds from the sale of investments |  | 70,669 |  | 23,787 |  | 2,426 |
Property, plant and equipment |  | 550 |  | 762 |  | 2,426 |
Other financial assets |  | 70,119 |  | 23,025 |  | — |
Net cash (used in) investing activities |  | (781,867 | ) | (2,185,880 | ) | (506,652 | )
Cash flows from/(used in) financing activities |  |  |  |  |  |  |
Proceeds from and payments for equity instruments |  | — |  | — |  | (11,766 | )
Issue |  | — |  | — |  | — |
Payments for treasury stock |  | — |  | — |  | (12,686 | )
Sales of treasury stock |  | — |  | — |  | 920 |
Proceeds from and payments for financial liability instruments |  | 37,418 |  | 1,808,771 |  | (80,149 | )
Issue |  | 179,350 |  | 1,912,615 |  | 81,513 |
Redemption and repayment |  | (141,932 | ) | (103,844 | ) | (161,662 | )
Dividends and interest on other equity instruments |  | (275,783 | ) | (218,260 | ) | (216,151 | )
Dividends paid |  | (278,841 | ) | (218,260 | ) | (216,151 | )
Dividends received |  | 3,058 |  | — |  | — |
Other cash flows from/(used in) financing activities |  | 4,661 |  | (156,446 | ) | (21,492 | )
Financing costs included on the amortized costs of the debt |  | — |  | (142,288 | ) | — |
Other amounts from / (used in) financing activities |  | 4,661 |  | (14,158 | ) | (21,492 | )
Transaction with minority interest with no loss of control |  | 386,207 |  | — |  | — |
Net cash from/(used in) financing activities |  | 152,503 |  | 1,434,065 |  | (329,558 | )
Effect of exchange rate fluctuations on cash |  | 39,207 |  | (98,419 | ) | 35,441 |
Net increase in cash and cash equivalents |  | 147,271 |  | (8,488 | ) | (247,491 | )
Cash and cash equivalents at beginning of the year |  | 886,521 |  | 895,009 |  | 1,142,500 |
Cash and cash equivalents at year end |  | 1,033,792 |  | 886,521 |  | 895,009 |

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Net Cash from Operating Activities

In 2016, we generated net cash from operating activities of €553.3 million. The principal effects on working capital were as follows:

· increase of €43.3 million in trade receivables (included in change in current trade and other receivables in the table above). The average collection period was 37 days, as compared to the 34 days level at December 31, 2015;

· increase of €173.0 million in inventory levels due to the greater strength of sales, especially of plasma proteins, and the new openings of plasma collection centers. We continue to actively manage inventory levels on an anticipatory basis in order to match planned organic growth. In this regard, inventory turnover was 281 days at December 31, 2016, compared with 261 days reported at December 31, 2015; and

· trade payables (included in change in current trade and other payables in the table above) rose by €31.6 million due to the increase in the average payment period to 61 days in 2016.

In 2017, we generated net cash from operating activities of €841.7 million. The principal effects on working capital were as follows:

· increase of €86.9 million in trade receivables (included in change in current trade and other receivables in the table above) primarily due to improved accounts receivable balances. The average collection period at December 31, 2017 was 24 days, as compared to 37 days at December 31, 2016;

· increase of €165.5 million in inventory levels due to ongoing improvements in value chain management amid a strong sales environment, particularly for plasma proteins. Grifols actively manages its inventory levels in advance to meet its expected growth plans, inventory turnover was 275 days at December 31, 2017, compared with 281 days reported at December 31, 2016; and

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· trade payables (included in change in current trade and other payables in the table above) increased by €4.3 million, while the average payment period decreased from 61 days at December 31, 2016 to 53 days at December 31, 2017.

In 2018, we generated net cash from operating activities of €737.4 million. The principal effects on working capital were as follows:

· positive impact of €33.3 million as a result of improvements in accounts receivable. The average collection period dropped to 22 days, compared to 24 days in 2017.

· improved payment management led to a positive impact of €117.1 million.

· increased inventory levels had a negative impact of €231.7 million due to higher volumes of plasma collected to meet the rising demand of the main plasma proteins. Grifols aims to manage its inventory in a way that anticipates the growing demand reflected by growth forecasts.

Net Cash from/(Used) in Investing Activities

Net cash used in investing activities amounted to €506.7 million in 2016, €2.2 billion in 2017 and €781.9 million in 2018.

Investments made in 2016 included the acquisition of a 49% equity stake in the IBBI Group for $100 million and the acquisition of shares in Progenika Biopharma, S.A. for €25 million, increasing our equity stake in Progenika to 89.25%.

Investments made in 2017 included the acquisition of Hologic’s assets related to the research, development and production of reagents and instruments based on NAT technology for $1.8 billion, the acquisition of a 49% stake in Access Biologicals for $51 million, the acquisition of six plasma centers to Kedrion for €47 million, the acquisition of a 44% stake in GigaGen for $35 million, and the acquisition of a 40% stake in Kiro Grifols for a total of €12.8 million, increasing Grifols’ aggregate stake in Kiro Grifols to 90%. Investments also included capital expenditures for a total of €271.1 million, allocated mainly to opening new plasma donation centers and the expansion, renovation and relocation of existing centers, as well as in the production plants of its three divisions.

Investments made in 2018 included the acquisition of a 51% stake in MedKeeper for $98 million, the acquisition of a 100% stake in Haema AG for €220 million and the acquisition of a 100% stake in Biotest US Corporation for $286 million. In December 2018, we sold our 100% stakes in Haema AG and Biotest US Corporation to Scranton Enterprises B.V. for the aggregate amount of $538 million. See “— Acquisitions — Acquisition and Sale of Haema AG and Biotest US Corporation” above.

Net Cash from/(Used) in Financing Activities

Net cash used in financing activities was €329.6 million in 2016, primarily as a result of the payment of dividends for a value of €216.2 million, including both the final dividend for 2015 and the interim dividend for 2016 distributed in December.

Net cash from financing activities was €1.4 billion in 2017, primarily as a result of our initial financing to acquire the share in the NAT technology donor-screening unit, and from dividend payouts of €218.3 million, which include the final dividend for 2016 and the interim dividend for 2017 distributed in December.

Net cash from financing activities was €152.5 million in 2018, primarily as a result of dividend payouts of €278.8 million and the subsequent sale of Haema and Biotest. Grifols maintains operating control of the plasma centers and holds an exclusive and irrevocable call option for both companies.

Working Capital

Our working capital, which is driven primarily by our trade receivables turnover and inventory aging, can vary significantly period to period depending on the activity. Our capital requirements will depend on many factors, including our rate of sales growth, acceptance of our products, continued access to adequate manufacturing capacities, maintaining cGMP compliant facilities, the timing and extent of research and development activities, and changes in operating expenses, including costs of production and sourcing of plasma, all of which are subject to uncertainty. We anticipate that our cash needs will be significant and that we may need to increase our borrowings under current or future debt agreements in order to fund our operations and strategic initiatives. We anticipate that our working capital will increase in absolute terms in order to grow our business.

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Inventory Aging

Inventory aging average decreased from 2016 to 2017, as a result of ongoing improvements in value chain management and strong sales environment, particularly for plasma proteins. Inventory turnover rose to 275 days at December 31, 2017, compared to 281 days at December 31, 2016. In 2018, inventory turnover increased to 292 days as a result of the implementation of several initiatives to better anticipate and meet the solid demand for plasma-derived products.

Trade Receivables

Our receivables had an aging average of 22, 24 and 37 days at December 31, 2018, 2017 and 2016 and 2015, respectively. We are focused on optimizing our working capital.

In the best interest of the Company, we may sell certain receivables with a maturity beyond 30 days. Certain receivables are sold to financial institutions without recourse. We sold €1,188 million, €912 million and €870 million of receivables to third parties during 2018, 2017 and 2016, respectively.

Capital Expenditures and Other Intangible Assets

The following table presents our capital expenditure additions in the years ended December 31, 2018, 2017 and 2016, by division.

|  | Year Ended December 31, |
|  | 2018 |  | 2017 |  | 2016 |
|  | (in thousands of euros) |
Bioscience division |  | 220,531 |  | 227,635 |  | 197,741 |
Hospital division |  | 15,354 |  | 10,429 |  | 9,193 |
Diagnostic division |  | 58,064 |  | 70,032 |  | 89,760 |
Bio Supplies |  | 2,050 |  | 198 |  | 84 |
Others |  | 883 |  | 20,911 |  | 13,313 |
Unallocated |  | 19,795 |  | 11,268 |  | 12,011 |
Total |  | 316,677 |  | 340,473 |  | 322,102 |

January 2016 through December 2018

Facilities. The most important capital projects relating to the expansion and improvement of our manufacturing facilities during 2016, 2017 and 2018 were:

Parets site (Barcelona, Spain):

· investments to increase purification capacity of fibrin sealant and topic thrombin of €1.3 million in 2017 and €8.9 million in 2018;

· investments in a plant to manufacture Prolastin-C® of €13.2 million in 2016, €4.0 million in 2017 and €0.7 million in 2018;

· investments to increase the albumin purification capacity of €0.1 million in 2016, and €1.6 million in 2018;

· investments to increase Factor VIII manufacturing capacity of €3.4 million in 2018;

· investments in new production lines for diagnostic gel cards of €2.2 million in 2016, €1.2 million in 2017 and €0.7 million in 2018;

· investments to increase the production of intravenous solutions bags of €1.2 million in 2016, €1.5 million in 2017 and €1.5 million in 2018;

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Clayton site (North Carolina, United States):

· construction of a new immunoglobulins purification and filling plant for €0.4 million in 2017 and €13.4 million in 2018;

· construction of a new 6 million liter fractionation plan; for €2.6 million in 2016, €29.1 million in 2017 and €43.9 million in 2018;

· completing the construction and bringing online a new plasma fractionation facility for €0.7 million in 2016;

· completion of a new plasma warehouse for €0.1 million in 2016;

· construction of a new raw materials warehouse for less than €0.1 million in 2016;

· investments in manufacturing areas for Factor VIII employing the method used at our Parets site for €0.8 million in 2017 and €2.4 million in 2018;

· investments in a new area for IG Subcutaneous for €0.4 million in 2016 and €2.2 million in 2017;

· investments of €4.8 million in 2016 and €0.9 million in 2017 for the construction of new aseptic filling areas, as well as validation of the new filling zone facilities and equipment for liquid and freeze-dried products;

· investments of €0.1 million in 2016 to expand the Gamunex purification area;

· construction of a convalescent plasma immunoglobulin facility to help develop treatments for diseases such as Ebola and others for €0.5 million in 2016; and

· land acquisitions in Clayton for €7.7 million in 2017 and €0.1 million in 2018.

Los Angeles (California, United States):

· increasing our albumin purification capacity and including a new presentation in ready-to-use flexible bags for €4.4 million in 2016, €1.5 million in 2017 and €0.8 million in 2018;

· investments to increase our IVIG purification capacity of €7.2 million in 2016, €2.6 million in 2017 and €0.9 million in 2018; and

· land and facilities acquisition in Los Angeles for €1.5 million in 2016.

Dublin (Ireland):

· aggregate investments of approximately €58 million to build a new headquarters, global operations and logistics center to serve as part of the new global operations center of the Bioscience division from 2015 to 2017 and €1.6 million in 2018;

· investment in a new albumin purification and filling plant for bags of €2.6 million in 2016, €28.5 million in 2017 and €26.9 million in 2018.

San Diego (California, United States):

· aggregate investments of €13.1 million from 2017 to 2018 to expand manufacturing capacity for our NAT Diagnostic business, including quality control and research and development labs.

Other Investments:

· investments in serialization to enhance manufacturing and packaging identification of €1.3 million in 2016, €3.1 million in 2017 and €3.8 million in 2018;

· significant investments in new donor centers and donor center expansions in the United States: investments of €21.8 million in 2015, €31 million in 2016, €40.5 million in 2017 and €17.8 million in 2018;

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· Emeryville, United States: investments of €33.3 million in 2016, €10.2 million in 2017 and €3.3 million in 2018 to consolidate the manufacturing of antigens in a new building;

· Campo Largo (Paraná), Brazil: land acquisition and construction of commercial offices and a plant to manufacture bags used for collection, storage and transfusion of blood components for €7.3 million in 2016, €3.7 million in 2017 and €2.2 million in 2018;

· Murcia, Spain: investments of €0.4 million in 2016, €0.2 million in 2017 and €0.1 million in 2018 to increase capacity to manufacture parenteral solutions by approximately eight million units, to approximately 35 million units and investments to increase Fleboflex manufacturing capacity of €2.3 million in 2016, €0.5 million in 2017 and €0.2 million in 2018;

· refurbishment of the Barcelona headquarters included €16.4 million in acquiring a new office building and investments in the refurbishment of the existing building of €1.0 million in 2016 and €0.6 million in 2017;

· acquisition of a new plot next to our Barcelona manufacturing facilities of 50,000 square meters that will allow future growth in both the Bioscience and Diagnostic divisions;

· investment in a new office building at the Clayton plant for €10.2 million in 2016 and €7.5 million in 2017; and

· investments to remodel our commercial offices worldwide of €1.6 million in 2016, €1.2 million in 2017 and €3.8 million in 2018, including new offices for Dubai, Paris, Beijing, Singapore, Chile and Tokyo.

January 2019 through December 2020

Pursuant to the Hologic transaction, which was completed on January 31, 2017, we acquired a facility located in San Diego, California. At the San Diego facility, we will manufacture oligos and other critical components of the Transcripted Mediated Amplification NAT kits for blood and plasma infectious diseases screening. Specific components focused on HIV, Hepatitis B and C, Parvo and Zika are among those being manufactured at the San Diego facility.

We are undertaking an investment plan that includes, among other capital expenditures, approximately $360 million from 2016 through 2021 to expand manufacturing capacity for our plasma derived therapies. We plan to finance our projected capital expenditures with internally generated cash flow, cash on hand and debt financing. These expenditures are included in our current investment plan.

The majority of our investments benefit our Bioscience division, with the goal of improving the structure of our plasma collection centers in the United States and expanding our manufacturing facilities. We aim to optimize utilization of our fractionation capacity by obtaining FDA and EMA licenses and completing other requirements to purify any of our intermediate products at any of our plants.

We are also expanding and relocating plasma donation centers and improving infrastructures related to raw materials classification, preparation and storage facilities, logistics centers and analysis laboratories. As of December 31, 2018, we have 197 operational plasma collection centers and plan to have 325 approved plasma collection centers globally by 2023.

With our acquisition of German company Haema, we have recovered the ability to have plasma collection centers in Europe as we keep expanding our U.S. centers.

The most important planned capital projects relating to the expansion and improvement of our manufacturing facilities are:

· Clayton: new fractionation building and purification and filling facility for 6 million liters of plasma annually.

· Clayton: new quality control labs and new finished product warehouse.

· Los Angeles: new fill & finish lines for Bioscience.

· Murcia: investments to increase our plastic manufacturing capacity;

· Dublin: completion of a purification, fill and finish plant for Albumin;

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· Emeryville: new manufacturing areas for Mammalian cells;

· San Diego: expansion of blood testing systems;

· construction of a new corporate building in Barcelona with an underground connection to unify the corporate site;

· construction of new buildings for Bioscience and Diagnostic divisions on the new Barcelona Lliçà land;

· construction of new plasma collection centers as well as further relocation and renovation of our existing centers and;

· expansion of our testing labs in Austin, San Marcos and Germany.

Sources of Credit

European Investment Bank Term Loans

On October 28, 2015, Grifols Worldwide Operations Limited entered into a loan agreement with the European Investment Bank for a term loan of €100 million under the European Fund for Strategic Investments, or the 2015 European Investment Bank Term Loan, which was amended on December 5, 2017. The financial terms of the loan agreement include a fixed interest rate of 2.40% for a tenor of ten years from October 28, 2015, and a repayment schedule with amortization in years three through ten. The proceeds of this loan are being used to support our research and development, primarily focusing on the search for new indications for plasmatic proteins, including the treatment of Alzheimer’s disease, vascular disease, cardiovascular surgery and arterial thrombosis, amongst others.

On December 5, 2017, Grifols, S.A. obtained a new long-term loan with the European Investment Bank totaling €85 million, or the 2017 European Investment Bank Term Loan. The financial terms of the loan include a fixed interest rate of 2.019% for a tenor of ten years and a two-year grace period. The proceeds of this loan are being used for research and development initiatives, notably the discovery and development of new products (plasma proteins), the finding of new therapeutic indications for existing plasma proteins and the improvement of manufacturing processes to increase yields, safety and efficiency.

On September 7, 2018, Grifols, S.A. obtained a new long-term loan with the European Investment Bank totaling €85 million, together with the 2015 European Investment Bank Term Loan and the 2017 European Investment Bank Term Loan, the European Investment Bank Term Loans. The financial terms of the loan agreement include a fixed interest rate of 2.145% for a tenor of 10 years and a two-year grace period. The proceeds of this loan are being used for research and development initiatives, notably the discovery of new therapeutic indications for plasma-derived protein therapies.

The European Investment Bank Term Loans are secured by a perfected first priority security interest (subject to permitted liens, as defined in the documentation governing the European Investment Bank Term Loans) on the same collateral securing the New Credit Facilities (except for, due to legal impediments, the pledge over the shares in the Spanish company named Instituto Grifols S.A.), subject to a customary pari passu intercreditor agreement entered into by and among Grifols, S.A., Grifols Worldwide Operations Limited, certain subsidiaries of Grifols, S.A. party thereto, the European Investment Bank and Bank of America, N.A., as collateral agent under the New Credit Facilities.

New Credit Facilities

On January 31, 2017 we entered into the New Credit Facilities with a syndicate led by Nomura Securities International, Inc., Bank of America Merrill Lynch International Limited, Bank of America, N.A., Goldman Sachs Bank USA and HSBC Bank plc, as the arrangers, which consists of the “Senior Term Loans” and the “Revolving Loans”. The initial Senior Term Loans were fully drawn down on January 31, 2017, and the incremental Senior Term Loans in an aggregate principal amount of $175 million were further drawn down on February 14, 2017. The tranche A term loans, in original principal amounts equal to $2,350 million and €607 million, will mature six years from January 31, 2017 and have a repayment schedule with quarterly amortization starting on the last business day of the fiscal quarter ending on March 31, 2019, equal to (i) 5.0%, 10.0% and 10.0% per annum of the original principal amount in fiscal years 2019, 2020 and 2021, respectively, payable in four equal quarterly installments in respect of each such fiscal year, and (ii) 75% per annum of the original principal amount in fiscal year 2022, payable in equal quarterly installments for the first three quarters of such fiscal year, with the remainder to be paid at maturity. The tranche B term loans, in original principal amount equal to $3.0 billion, will mature eight years from January 31, 2017 and will have a repayment schedule with quarterly amortization equal to 1.0% per annum of the original principal amount, with the remainder to be paid at maturity. The Revolving Loans, which amount to

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$300 million equivalent in multicurrencies, are available during the period commencing from January 31, 2017 and ending on the sixth anniversary of the closing of January 31, 2017.

The interest rates on the Senior Term Loans and the Revolving Loans are based on (a) in the case of dollar denominated loans, the base rate (the greatest of (i) the prime rate, (ii) the federal funds rate plus 0.50% and (iii) the applicable LIBOR rate plus 1.00%) plus an applicable margin or (b) the applicable LIBOR rate, plus an applicable margin. The applicable margin for loans at the LIBOR rate is (a) 1.75% for the multicurrency revolving loans and the tranche A term loan and (b) 2.25% for the tranche B term loan.

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Borrowings under the New Credit Facilities are subject to mandatory prepayment upon the occurrence of certain events, including the incurrence of certain debt and the sale or other disposition of certain assets. In addition, a portion of the borrowings under the New Credit Facilities are subject to mandatory prepayment in the event we have excess cash flow, as defined therein. Both the Senior Term Loans and the Revolving Loans are guaranteed by Grifols, S.A. and certain subsidiaries of Grifols, S.A. that together with Grifols, S.A. represent, in the aggregate, at least 80% of the consolidated assets and consolidated EBITDA, as defined in the agreements, of Grifols, S.A. and its subsidiaries, and are secured by a perfected first priority security interest (subject to permitted liens, as defined in the New Credit Facilities) in all of the tangible and intangible assets of the U.S. credit parties and plasma inventory of the Foreign Borrower, as defined therein and pledges of equity of certain subsidiaries of Grifols, S.A. (subject to certain exclusions and limitations). The New Credit Facilities require the borrowers to ensure that (i) the aggregate EBITDA attributable to the guarantors of the New Credit Facilities as a group is no less than 80% of the consolidated EBITDA of Grifols, S.A. and its subsidiaries, (ii) the aggregate total assets of the guarantors of the New Credit Facilities as a group are no less than 80% of the consolidated total assets of Grifols, S.A. and its subsidiaries, and (iii) any subsidiary of Grifols S.A. that has EBITDA or total assets representing 10% or more of the consolidated EBITDA or consolidated total assets, respectively, of Grifols, S.A. and its subsidiaries, is a guarantor.

The New Credit Facilities include customary affirmative and negative covenants and events of default. Negative covenants include, among other limitations, limitations on additional debt, liens, asset sales and affiliate transactions. Events of defaults include, among other events, violation of covenants, material breaches of representations, cross default to other material debt, bankruptcy and insolvency and material judgments.

The terms of the New Credit Facilities contain limitations on our ability to pay ordinary dividends. We may pay dividends (a) in the ordinary course of business consistent with past practices in an amount not to exceed in respect of any fiscal year, 40% of the consolidated net income of Grifols, S.A. and its subsidiaries for such fiscal year, which may be paid in installments, the first, no earlier than December of such fiscal year and the last, no later than the following fiscal year or (b) whether or not in the ordinary course of business so long as after giving effect thereto, the leverage ratio is not greater than 3.5x.

The borrower under the U.S. dollar tranche A facility and the revolving facility is Grifols Worldwide Operations Limited, an Irish entity and our wholly owned direct subsidiary. The borrower under the Euro-denominated tranche A facility is Grifols, S.A. The borrower under the tranche B facility is Grifols Worldwide Operations USA, Inc., a Delaware corporation and a direct wholly owned subsidiary of Grifols Worldwide Operations Limited. The New Credit Facilities are governed by New York law, however, certain collateral documents are governed under the local law of other jurisdictions.

The 2017 Notes

On April 26, 2017, Grifols, S.A. issued €1.0 billion senior unsecured notes, or the 2017 Notes, that will mature on May 1, 2025 and bear interest at 3.20% per annum. The 2017 Notes were exchanged for 97.1% of the $1.0 billion senior unsecured notes issued in March 2014 by Grifols Worldwide Operations Limited, a 100% subsidiary of Grifols, S.A. with a maturity in 2022 and bearing interest at 5.25% per annum, or the 2014 Notes. The remaining 2.9% of the 2014 Notes was redeemed before the exchange in an amount of €27 million. On May 2, 2017, the 2017 Notes were listed on the Global Exchange Market of the Irish Stock Exchange. This exchange has allowed us to reduce our finance costs and extend our maturities.

The 2017 Notes pay interest semi-annually in arrears on May 1 and November 1, commencing on November 1, 2017. The 2017 Notes are guaranteed on a senior unsecured basis by Grifols, S.A. and the subsidiaries of Grifols, S.A. that are guarantors and co-borrowers under the New Credit Facilities. As of the date of this annual report on Form 20-F, the 2017 Notes are guaranteed by Biomat USA, Inc., Grifols Biologicals LLC, Grifols Shared Services North America, Inc., Grifols Diagnostic Solutions Inc., Grifols Therapeutics LLC, Instituto Grifols, S.A., Grifols USA, LLC, Grifols Worldwide Operations Limited and Grifols Worldwide Operations USA, Inc.

Grifols, S.A. may redeem the 2017 Notes, in whole or in part, at any time on and after May 1, 2020, at the redemption prices (expressed as percentages of principal amount) set forth below plus accrued and unpaid interest, if any, on the 2017 Notes redeemed, to the applicable redemption date, if redeemed during the twelve-month period beginning on May 1 of the years indicated below:

Fiscal Year |  | Percentage |
2020 |  | 101.600 | %
2021 |  | 100.800 | %
2022 and thereafter |  | 100.000 | %

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Grifols, S.A. may redeem up to 40% of the outstanding 2017 Notes with money raised in one or more equity offerings by Grifols, S.A. at any time (which may be more than once) prior to May 1, 2020, as long as at least 60% of the aggregate principal amount of 2017 Notes issued remains outstanding immediately following any such offerings.

Grifols, S.A. may redeem some or all of the 2017 Notes at any time prior to May 1, 2020 at a price equal to 100% of the principal plus a premium as defined under the indenture (computed using a discount rate equal to the Bund rate as of such redemption date plus 0.50%), plus accrued and unpaid interest, if any.

Grifols, S.A. is not required to make mandatory redemption or sinking fund payments with respect to the 2017 Notes.

If Grifols, S.A. experiences a change of control, it must give holders of the 2017 Notes the opportunity to sell to us their 2017 Notes at 101% of their face amount, plus accrued and unpaid interest.

Grifols, S.A. and the guarantors of the 2017 Notes may incur additional indebtedness if the fixed charge coverage ratio (as defined in the indenture governing the 2017 Notes) for Grifols, S.A. and the restricted subsidiaries (as defined in the indenture governing the 2017 Notes) on a consolidated basis for the most recently ended four full fiscal quarters immediately preceding the date on which such additional indebtedness is incurred would have been at least 2.00 to 1.00, determined on a pro forma basis.

The indenture governing the 2017 Notes contains certain covenants limiting, subject to exceptions, carve-outs and qualifications, Grifols, S.A.’s ability and its restricted subsidiaries’ ability to: (i) pay dividends or make certain other restricted payments or investments; (ii) incur additional indebtedness or provide guarantees of indebtedness and issue disqualified stock; (iii) create liens on assets; (iv) merge, consolidate, or sell all or substantially all of our and our restricted subsidiaries’ assets; (v) enter into certain transactions with affiliates; (vi) create restrictions on dividends or other payments by our restricted subsidiaries; and (vii) create guarantees of indebtedness by restricted subsidiaries. The indenture also contains certain customary events of default.

Other Debt

Certain other credit facilities and capital lease obligations are in place with various lenders and consist of long-term and short-term indebtedness of both us and Grifols, S.A. subsidiaries. As of December 31, 2018, we have €16.3 million of aggregate short-term credit under these facilities. The short-term credit facilities have maturity dates occurring in the next 12 months.

D. Trend Information

Plasma-derived protein therapies are essential to extend and improve the lives of individuals suffering from chronic, acute and life-threatening conditions including infectious diseases, such as hepatitis, immunological diseases, such as multiple sclerosis, hemophilia, von Willebrand disease, liver dialysis and acute conditions such as burns and severe blood loss. For this reason, the administration of these products cannot be interrupted or postponed without putting patients’ lives at risk. This ensures a stable demand for such products. In addition, because of the nature of the diseases treated, the reimbursement rates for plasma derivative products in the United States are high. Any changes to such rates would likely elicit a strong lobbying response in the United States.

Based on MRB reports, sales in the human plasma-derived product industry have grown at a compound annual rate of 10.6% globally from 2005 to 2016 and 13.4% in the United States alone from 2005 to 2015. We believe that many plasma derivative products are underutilized and will continue to benefit from strong demand. Additionally, new indications are being explored for a number of plasma-derived therapies, such as the treatment of Alzheimer’s disease. We believe that the volume of global sales of plasma derivative products will continue to grow annually at 6% to 7% over the long term, driven primarily by the same factors that have contributed to its historical growth, including:

· population growth;

· the discovery and approval of new applications and indications for plasma-based products;

· an increase in the number of diagnosed patients and diagnosed but previously-untreated patients;

· geographic expansion; and

· physicians’ greater awareness of conditions and treatments.

Approximately 17.8% of our sales were generated in the European Union in 2018, as compared to 15.9% in 2017 and 16.1% in 2016. We anticipate that the percentage of our sales generated in the European Union will not significantly increase in 2019.

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There are significant barriers to entry into the plasma derivative products industry, as the industry is highly regulated and requires significant expertise and capital investments. We do not expect these barriers to decrease in the near term.

Regulatory Environment. In order to operate in the plasma derivatives industry, manufacturers and distributors must comply with extensive regulation by the FDA, the EMA and comparable authorities worldwide. As a result, significant investments are required to develop, equip and maintain the necessary storage, fractionation and purification facilities and to develop appropriate sale, marketing and distribution infrastructures. Additionally, only proteins derived from plasma collected at FDA-approved centers can be marketed in the United States, so securing an adequate supply of U.S. source plasma is required to operate in the United States. We expect these regulatory restrictions to continue.

Product Pipeline. We have an expanded portfolio of key products as a result of our recent acquisitions and will continue to invest in research and development with respect to new product and new indications for existing products. Some key research and development projects underway include clinical studies of the use of albumin, diagnostic and vaccine therapies to treat Alzheimer’s disease, of albumin to treat advance cirrhosis and ascites, and of antithrombin in heart surgery.

Capital Expenditures. From 2016 through 2020, we are undertaking a €1.2 billion investment plan that involves among other investments, cumulative industrial capital investments to expand the manufacturing capacities of the Bioscience division as well as investments in the Diagnostic and Hospital divisions.

E. Off-balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

F. Contractual Obligations

The following table presents our principal existing contractual obligations as of December 31, 2018, requiring future payments:

|  | Payments Due by Period |
|  | Total |  | Less than one year |  | One to three years |  | Three to five years |  | More than five years |
|  | (in thousands of euros) |
Operating leases(1) |  | 438,252 |  | 97,222 |  | 115,611 |  | 88,543 |  | 136,876 |
Financial debt obligations(2) |  | 6,608,822 |  | 290,336 |  | 641,520 |  | 2,174,111 |  | 3,502,855 |
Interest — financial debt obligations(3) |  | 1,232,329 |  | 240,890 |  | 241,141 |  | 721,025 |  | 29,273 |
Licenses and royalties(4) |  | 24,284 |  | 4,291 |  | 8,336 |  | 8,287 |  | 3,370 |
Total |  | 8,303,686 |  | 632,739 |  | 1,006,608 |  | 2,991,966 |  | 3,672,374 |

(1) Operating leases include primarily leases for our plasma collection centers, leases from sale-leaseback transactions and marketing offices worldwide. These amounts reflect only our contractual obligations as of December 31, 2018, and therefore assume that these operating leases will not be renewed or replaced with new operating leases upon expiration. Our operating lease expenses will likely be substantially higher than the amounts provided in this table because our operations will require us to either renew or replace our operating leases.

(2) Includes principal amortization for short- and long-term debt including, among other things, capitalized lease obligations. The remaining financial debt was made up largely of bilateral facilities that bore interest at market rate.

(3) Interest payments on debt and capital lease obligations are calculated for future periods using interest rates in effect at the end of 2018. Certain of these projected interest payments may differ in the future based on changes in floating interest rates, foreign currency fluctuations or other factors or events. The projected interest payments only pertain to obligations and agreements outstanding at December 31, 2018. Refer to Notes 20 and 30 to our audited consolidated financial statements included in this annual report on Form 20-F for further discussion regarding our debt obligations and related interest rate agreements outstanding at December 31, 2018.

(4) License and royalty payment formulas are generally based on volume of sales. The amounts presented in the table are calculated based on the net revenue of 2018 without assuming any growth in sales. Additionally, the column “More than five years” includes only one year of payments under the license agreement with Marca Grifols, S.L., which expires in January 2092.

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G. Safe Harbor

See “Cautionary Statement Regarding Forward-Looking Statements” on page ii of this annual report on Form 20-F.

Other Disclosures

Financial Derivatives

See Note 30 to our audited consolidated financial statements included in this annual report on Form 20-F for additional information regarding our derivative instruments.

The New Credit Facilities permit us to enter into hedging transactions.

Critical Accounting Policies

The preparation of consolidated financial statements in accordance with IFRS requires us to make estimates and judgments in certain circumstances that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosures of contingent assets and liabilities. A detailed description of our significant accounting policies is included in the notes to our audited consolidated financial statements included elsewhere in this annual report on Form 20-F.

We believe that certain of our accounting policies are critical because they require subjective and complex judgments, often requiring the use of estimates about the effects of matters that are inherently uncertain. We apply estimation methodologies consistently from year to year. Other than changes required due to the issuance of new accounting guidance, there have been no significant changes in our application of critical accounting policies during the periods presented. We periodically review our critical accounting policies and estimates with the Audit Committee of our Board. The following is a summary of accounting policies that we consider critical to our consolidated financial statements.

(a) Business combinations

We apply IFRS 3 (revised), Business combinations in transactions made subsequent to January 1, 2010, applying the acquisition method of this standard to business combinations. The acquisition date is the date on which we obtain control of the acquiree.

The consideration paid excludes all amounts that do not form part of the exchange for the acquired business. Acquisition related costs are accounted for as expenses when incurred. Share capital increase costs are recognized as equity when the increase takes place and borrowing costs are deducted from the related financial liability when it is recognized.

At the acquisition date, we recognize at fair value the assets acquired and liabilities assumed. Liabilities assumed include any contingent liabilities that represent present obligations arising from past events for which the fair value can be reliably measured. We also recognize indemnification assets transferred by the seller at the same time and following the same measurement criteria as the item that is subject to indemnification from the acquired business, taking into consideration, where applicable, the insolvency risk and any contractual limit on the indemnity amount.

Assets and liabilities assumed are classified and designated for subsequent measurement in accordance with the contractual terms, economic conditions, operating or accounting policies and other factors that exist at the acquisition date, except for leases and insurance contracts.

The excess between the consideration transferred and the value of net assets acquired and liabilities assumed, less the value assigned to non-controlling interests, is recognized as goodwill.

When a business combination has been determined provisionally, adjustments to the provisional values only reflect information relating to events and circumstances existing at the acquisition date and which, had they been known, would have affected the amounts recognized at that date. Once this period has elapsed, adjustments are made to initial values only when errors must be corrected. Any potential benefits arising from tax losses and other deferred tax assets of the acquiree that were not recorded because they did not qualify for recognition at the acquisition date are accounted for as income tax revenue, provided the adjustments were not made during the measurement period.

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(b) Property, plant and equipment

(i) Depreciation

Property, plant and equipment are depreciated by allocating the depreciable amount of an asset on a systematic basis over its useful life. The depreciable amount is the cost or deemed cost of an asset less its residual value. We determine the depreciation charge separately for each component of property, plant and equipment with a cost that is significant in relation to the total cost of the asset.

Property, plant and equipment are depreciated using the following criteria:

|  | Depreciation method |  | Rates
Buildings |  | Straight line |  | 1%–3%
Other property, technical equipment and machinery |  | Straight line |  | 4%–10%
Other property, plant and equipment |  | Straight line |  | 7%–33%

We review residual values, useful lives and depreciation methods at each fiscal year end. Changes to initially established criteria are accounted for as a change in accounting estimates.

(ii) Subsequent recognition

Subsequent to the initial recognition of the asset, only those costs incurred which will probably generate future profits and for which the amount may reliably be measured are capitalized. Costs of day-to-day servicing are recognized in profit or loss as incurred.

Replacements of property, plant and equipment which qualify for capitalization are recognized as a reduction in the carrying amount of the items replaced. Where the cost of the replaced items has not been depreciated independently and it is not possible to determine the respective carrying amount, the replacement cost is used as indicative of the cost of items at the time of acquisition or construction.

(iii) Impairment

We test for impairment and reversals of impairment losses on property, plant and equipment based on the criteria set out below in (d).

(c) Intangible assets

(i) Goodwill

Goodwill is generated in the course of business combinations and is calculated using the criteria described in the section on business combinations.

Goodwill is not amortized, but tested for impairment annually or more frequently if events indicate a potential impairment loss. Goodwill acquired in business combinations is allocated to the cash generating units, which we refer to as CGUs, or groups of CGUs that are expected to benefit from the synergies of the business combination, and we apply the criteria described in the footnotes to our audited consolidated financial statements included elsewhere in this annual report on Form 20-F. After initial recognition, goodwill is measured at cost less any accumulated impairment losses.

(ii) Internally generated intangible assets

Any research and development expenditure incurred during the research phase of projects is recognized as an expense when incurred.

Costs related with development activities are capitalized when:

· we have technical studies that demonstrate the feasibility of the production process;

· we have undertaken a commitment to complete production of the asset to make it available for sale or internal use;

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· the asset will generate sufficient future economic benefits; and

· we have sufficient technical and financial resources to complete development of the asset and have developed budget control and cost accounting systems that enable monitoring of budgetary costs, modifications and the expenditures actually assigned to different projects.

The cost of internally generated assets is calculated using the same criteria established for determining production costs of inventories. The production cost is capitalized by allocating the costs attributable to the asset to self-constructed non-current assets through the consolidated statement of profit or loss.

Expenditures on activities that contribute to increasing the value of the different businesses in which we operate are expensed when incurred. Replacements or subsequent costs incurred on intangible assets are generally recognized as an expense, except where they increase the future economic benefits expected to be generated by the assets.

(iii) Other intangible assets

Other intangible assets are carried at cost, or at fair value if they arise on business combinations, less accumulated amortization and impairment losses.

Intangible assets with indefinite useful lives are not amortized but tested for impairment at least annually.

(iv) Intangible assets acquired in business combinations

The cost of identifiable intangible assets acquired in the business combination of Progenika includes the fair value of the currently marketed products sold, which are classified in “Other intangible assets” and “Development costs”.

The cost of identifiable intangible assets acquired in the business combination of Novartis includes the fair value of the existing royalty agreements.

(v) Useful life and amortization rates

We assess whether the useful life of each intangible asset acquired is finite or indefinite. An intangible asset is regarded as having an indefinite useful life when there is no foreseeable limit to the period over which the asset will generate net cash inflows.

Intangible assets with finite useful lives are amortized by allocating the depreciable amount of an asset on a systematic basis over its useful life, by applying the following criteria:

|  | Amortization method |  | Rates
Development expenses |  | Straight line |  | 10%
Concessions, patents, licenses, trademarks and similar |  | Straight line |  | 4 %–20%
Computer software |  | Straight line |  | 33%
Currently marketed products |  | Straight line |  | 3 %–10%

The depreciable amount is the cost or deemed cost of an asset less its residual value.

The Group does not consider the residual value of its intangible assets to be material. The Group reviews the residual value, useful life and amortization method for intangible assets at each fiscal year end. Changes to initially established criteria are accounted for as a change in accounting estimates.

(d) Impairment of goodwill, other intangible assets and other non-financial assets subject to depreciation or amortization

We evaluate whether there are indications of possible impairment losses on non-financial assets subject to amortization or depreciation to verify whether the carrying amount of these assets exceeds the recoverable amount.

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We test goodwill, intangible assets with indefinite useful lives, and intangible assets with finite useful lives that are not available for use for potential impairment at least annually, irrespective of whether there is any indication that the assets may be impaired.

The recoverable amount of the assets is the higher of their fair value less costs of disposal and their value in use. An asset’s value in use is calculated based on an estimate of the future cash flows expected to derive from the use of the asset, expectations about possible variations in the amount or timing of those future cash flows, the time value of money, the price for bearing the uncertainty inherent in the asset and other factors that market participants would reflect in pricing the future cash flows deriving from the asset.

Negative differences arising from comparison of the carrying amounts of the assets with their recoverable amounts are recognized in the consolidated statement of profit or loss. Recoverable amount is determined for each individual asset, unless the asset does not generate cash inflows that are largely independent of those from other assets or groups of assets. If this is the case, recoverable amount is determined for the CGU to which the asset belongs.

Impairment losses recognized for cash generating units are first allocated, where applicable, to reduce the carrying amount of goodwill allocated to the CGU and then to the other assets of the CGU pro rata on the basis of the carrying amount of each asset. The carrying amount of each asset may not be reduced below the highest of (i) its fair value less costs of disposal, (ii) its value in use and (iii) zero.

At the end of each reporting period we assess whether there is any indication that an impairment loss recognized in prior periods may no longer exist or may have decreased. Impairment losses on goodwill are not reversible. Impairment losses on other assets are only reversed if there has been a change in the estimates used to calculate the recoverable amount of the asset.

A reversal of an impairment loss is recognized in consolidated profit or loss. The increase in the carrying amount of an asset attributable to a reversal of an impairment loss may not exceed the carrying amount that would have been determined, net of depreciation or amortization, had no impairment loss been recognized.

A reversal of an impairment loss for a CGU is allocated to its assets, except for goodwill, pro rata with the carrying amounts of those assets. The carrying amount of an asset may not be increased above the lower of its recoverable value and the carrying amount that would have been obtained, net of amortization or depreciation, had no impairment loss been recognized.

(e) Inventories

Inventories are measured at the lower of cost and net realizable value. The cost of inventories comprises all costs of purchase, costs of conversion and other costs incurred in bringing the inventories to their present location and condition.

The costs of conversion of inventories include costs directly related to the units of production and a systematic allocation of fixed and variable production overheads that are incurred in converting materials into finished goods. The allocation of fixed indirect overheads is based on the higher of normal production capacity or actual production.

The raw material used to produce hemoderivatives is human plasma, which is obtained from our donation centers using the plasmapheresis method. The cost of inventories includes the amount paid to plasma donors, or the amount billed by the seller when plasma is purchased from third parties, as well as the cost of products and devices used in the collection process, rental expenses and storage. This plasma has to be stored before use, which is an essential part of the production process. During the storage period, the plasma undergoes various virological tests and should be kept in quarantine in accordance with FDA and EMA regulations, in order to guarantee that all the plasma is suitable for use in the production process.

To the extent that plasma storage costs are necessary to the production process, they are included as cost of inventories.

Indirect costs such as general management and administration costs are recognized as expenses in the period in which they are incurred.

The cost of raw materials and other supplies and the cost of merchandise are allocated to each inventory unit on a weighted average cost basis. The transformation cost is allocated to each inventory unit on a first in, first out basis.

We use the same cost model for all inventories of the same nature and with a similar use.

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Volume discounts extended by suppliers are recognized as a reduction in the cost of inventories when it is probable that the conditions for discounts to be received will be met. Discounts for prompt payment are recognized as a reduction in the cost of the inventories acquired.

When the cost of inventories exceeds the net realizable value, materials are written down to net realizable value. Net realizable value is considered as detailed below.

· Raw materials and other supplies: replacement cost. Nevertheless, raw materials and other supplies are not written down below cost if the finished goods into which they will be incorporated are expected to be sold at or above cost of production.

· Merchandise and finished goods: estimated selling price, less costs to sell.

· Work in progress: the estimated selling price of related finished goods, less the estimated costs of completion and the estimated costs necessary to make the sale.

The previously recognized write-down is reversed against profit or loss when the circumstances that previously caused inventories to be written down no longer exist or when there is clear evidence of an increase in net realizable value because of changed economic circumstances. The reversal of the write-down is limited to the lower of the cost and revised net realizable value of the inventories. Write-downs may be reversed with a credit to “Changes in inventories of finished goods and work in progress and supplies”.

(f) Revenue recognition

Revenue from the sale of goods or services is recognized at an amount that reflects the consideration that the Group expects to be entitled to receive in exchange for transferring goods or services to a customer, at the time when the customer obtains control of the goods or services rendered. The consideration that is committed in a contract with a client can include fixed amounts, variable amounts, or both. The amount of the consideration may vary due to discounts, reimbursements, incentives, performance bonuses, penalties or other similar items. Contingent consideration is included in the transaction price when it is highly probable that the amount of revenue recognized is not subject to future significant reversals. Revenue is presented net of value added tax and any other amount or tax, which in substance corresponds to amounts received on behalf of third parties.

(i) Sale of goods

Revenue from the sale of goods is recognized when the Group meets the performance obligation by transferring the assets committed to the customer. An asset is transferred when the customer obtains control of that asset. When evaluating the satisfaction of the performance obligation, the Group considers the following indicators of the transfer of control, which include, but are not limited to the following:

· The Group has a present right to payment for the asset

· The customer has the legal right to the asset

· The Group has transferred the physical possession of the asset

· The customer has the significant risks and rewards of ownership of the asset

· The customer has accepted the asset

The Group participates in the government-managed Medicaid programs in the United States, accounting for Medicaid rebates by recognizing an accrual at the time a sale is recorded for an amount equal to the estimated claims for Medicaid rebates attributable to the sale. Medicaid rebates are estimated based on historical experience, legal interpretations of the applicable laws relating to the Medicaid program and any new information regarding changes in the program regulations and guidelines that would affect rebate amounts. Outstanding Medicaid claims, Medicaid payments and inventory levels are analyzed for each distribution channel and the accrual is adjusted periodically to reflect actual experience. While rebate payments are generally made in the following or subsequent quarter, any adjustments for actual experience have not been material.

As is common practice in the sector, the purchase contracts signed by some customers with the Group entitle these customers to price discounts for a minimum purchase volume, volume discounts or prompt payment discounts. The Group recognizes these discounts as a reduction in sales and receivables in the same month that the corresponding sales are invoiced

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based on the customer’s actual purchase figures or on past experience when the customer’s actual purchases will not be known until a later date.

In the U.S., the Group enters into agreements with certain customers to establish contract pricing for our products, which these entities purchase from the authorized wholesaler or distributor (collectively, wholesalers) of their choice. Consequently, when the products are purchased from wholesalers by these entities at the contract price which is less than the price charged by the Group to the wholesaler, the Group provides the wholesaler with a credit referred to as a chargeback. The Group records the chargeback accrual at the time of the sale. The allowance for chargebacks is based on the Group’s estimate of the wholesaler inventory levels, and the expected sell-through of the products by the wholesalers at the contract price based on historical chargeback experience and other factors. The Group periodically monitors the factors that influence the provision for chargebacks, and makes adjustments when it considers that actual chargebacks may differ from established allowances. These adjustments occur in a relatively short period of time. As these chargebacks are typically settled within 30 to 45 days of the sale, adjustments for actual experience have not been material.

(g) Leases

(i) Lessee accounting records

We have rights to use certain assets through lease contracts.

Leases in which we assume substantially all the risks and rewards incidental to ownership are classified as finance leases, and all other leases are classified as operating leases.

· Finance leases: We recognize finance leases as assets and liabilities at the commencement of the lease term, at the lower of the fair value of the leased asset and the present value of the minimum lease payments. Initial direct costs are added to the asset’s carrying amount. Minimum lease payments are apportioned between the finance charge and the reduction of the outstanding liability. The finance charge is allocated to each period during the lease term so as to produce a constant periodic rate of interest on the remaining balance of the liability. Contingent rents are recognized as expenses in the years in which they are incurred.

· Operating leases: We recognize lease payments under an operating lease, excluding incentives, as expenses on a straight-line basis unless another systematic basis is representative of the time pattern of the lessee’s benefit.

(ii) Sale-leaseback transactions

Any profit on sale leaseback transactions that meet the conditions of a finance lease is deferred over the term of the lease.

When the leaseback is classified as an operating lease:

· If the transaction is at fair value, any profit or loss on the sale is recognized immediately in consolidated statement of profit or loss for the year; or

· If the sale price is below fair value, any profit or loss is recognized immediately in the consolidated statement of profit or loss. However, if the loss is compensated for by future below market lease payments, it is deferred in proportion to the lease payments over the period for which the asset is to be used.

Changes in Accounting Standards

More information on newly issued accounting standards is included in Note 2 to our audited consolidated financial statements included in this annual report on Form 20-F.

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Item 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

A. Directors and Senior Management

Directors

Set forth below are the names and current positions of the members of the Board:

Name |  | Age |  | Title |  | Type |  | Director Since |  | Term Expires
Víctor Grifols Roura |  | 69 |  | Director, non-executive Chairman of the Board |  | Proprietary |  | July 1991(1) |  | May 2021
Víctor Grifols Deu |  | 42 |  | Director and Chief Executive Officer |  | Executive |  | May 2016 |  | May 2020
Raimon Grifols Roura |  | 55 |  | Director and Chief Executive Officer |  | Executive |  | May 2015 |  | May 2019
Ramón Riera Roca |  | 64 |  | Director |  | Other External |  | April 2000(2) |  | May 2021
Tomás Dagá Gelabert |  | 63 |  | Director and Vice-Secretary of the Board |  | Other External |  | April 2000 |  | May, 2019
Thomas H. Glanzmann |  | 60 |  | Director and Vice-chairman of the Board of Directors |  | Other External |  | April 2006 |  | May 2020
Anna Veiga Lluch |  | 62 |  | Director |  | Independent |  | December 2008 |  | May, 2019
Luís Isasi Fernández de Bobadilla |  | 62 |  | Director |  | Independent |  | May 2011 |  | May 2020
Steven Francis Mayer |  | 59 |  | Director |  | Independent |  | January 2011 |  | May 2020
Belén Villalonga Morenés |  | 50 |  | Director |  | Independent |  | May 2013 |  | May 2022
Marla E. Salmon |  | 69 |  | Director |  | Independent |  | May 2014 |  | May 2022
Carina Szpilka Lázaro |  | 50 |  | Director |  | Independent |  | May 2015 |  | May 2019
Iñigo Sánchez-Asiaín Mardones |  | 55 |  | Director and Lead Independent Director(3) |  | Independent |  | May 2015 |  | May 2019
Nuria Martín Barnés |  | 60 |  | Secretary non-member of the Board of Directors |  | n/a |  | May 2015 |  | n/a

(1) Between July 8, 1991 and May 30, 2002, Mr. Víctor Grifols Roura was not a director but sat on the Board as representative of our then director Deria, S.A.

(2) Between May 25, 2001 and May 30, 2002, Mr. Ramón Riera Roca was not a director but sat on the Board as representative of our then director Grifols International, S.A.

(3) The lead independent director is a new figure introduced by Law 31/2014, adopted on December 3, 2014, that amended the Spanish Companies Act in matters of corporate governance, or Law 31/2014. It is mandatory to appoint a lead independent director when the office of Chairman of the Board and that of chief executive officer is held by the same person. The lead independent director must (i) be an independent director and be authorized to request the calling of a board meeting or the inclusion of new points on the agenda of a board meeting already convened, (ii) coordinate and gather the non-executive directors and (iii) direct, when applicable, the Chairperson’s periodic evaluation by the Board. The Board in its meeting held on December 16, 2016, agreed to maintain Iñigo Sánchez-Asiaín Mardones as the Company’s Lead Independent Director as from January 1, 2017 even if from that date onwards the position is not mandatory since the office of the Chairman of the Board and that of chief executive officer is no longer held by the same person.

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Director Biographies

Víctor Grifols Roura

Mr. Víctor Grifols Roura is non-executive Chairman and proprietary director since January 1, 2017. From 1985 to 2017, he held the role of Chief Executive Officer and top executive of the Grifols Group, succeeding his father, Mr. Víctor Grifols Lucas. Mr. Víctor Grifols Roura spearheaded the 1987 reorganization that created Grifols as it is today. Mr. Víctor Grifols Roura originally joined the Group in 1973 as an Export Manager and later served as Sales Manager. Since 2014, he has been a member of the board of directors of Criteria Caixa, S.A. Sociedad Unipersonal. Mr. Grifols Roura earned a business administration degree from the University of Barcelona. As part of the approved Company’s succession plan on January 1, 2017, Mr. Víctor Grifols Deu and Mr. Raimon Grifols Roura were appointed co-CEOs of the Company.

Mr. Víctor Grifols Roura is a shareholder of Deria S.A. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act). He is also a shareholder of Scranton Enterprises, B.V. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act). Ms. Nuria Roura Carreras (Rodellar Amsterdam Holdings B.V.) is the mother of Mr. Víctor Grifols Roura.

Víctor Grifols Deu

Mr. Víctor Grifols Deu is Grifols’ joint and several Chief Executive Officer together with Mr. Raimon Grifols Roura since January 1, 2017. He succeeded his father, Mr. Víctor Grifols Roura in the position. He is a member of the administration bodies of several companies within the Grifols Group and was appointed executive director in May 2016. He joined the Company in 2001 as an analyst in the Planning and Control Department of the Company. In 2008 he became the director of the Planning and Control Department and was also appointed a member of the Executive Committee. He has been part of the team that analyzed and was responsible for the integration of operations after the acquisition of Alpha Therapeutics, Talecris Biotherapeutics and Novartis’ Transfusion Diagnostic Unit. He graduated in Business Administration and Management from the Ramon Llull University — Sarrià Chemical Institute and holds a postgraduate degree in Business Administration and Management from Michael Smurfit Business School in Dublin. Mr. Víctor Grifols Deu is the grandson of Ms. Nuria Roura Carreras (Rodellar Amsterdam Holdings B.V.).

Raimon Grifols Roura

Mr. Raimon Grifols Roura is Grifols’ joint and several Chief Executive Officer together with Mr. Víctor Grifols Deu since January 1, 2017. He succeeded his brother, Mr. Víctor Grifols Roura in the position. He is a member of the administration bodies of several companies within the Grifols Group. From 2001 to 2015 he held the role of non-member secretary of the Board of Directors of Grifols, S.A., and in 2015 began serving as director and Vice Secretary of the Board of Directors. In May 2016, the Board accepted his resignation as Vice Secretary. Until his appointment as executive director in July 2016, Mr. Grifols Roura was a partner at the law firm Osborne Clarke in Spain. Mr. Grifols Roura earned his law degree from the University of Barcelona (Universidad de Barcelona).

Mr. Raimon Grifols Roura is the sole director and a shareholder of Deria S.A. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act). He is also a shareholder of Scranton Enterprises, B.V. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act). Ms. Nuria Roura Carreras (Rodellar Amsterdam Holdings B.V.) is the mother of Mr. Raimon Grifols Roura.

Ramón Riera Roca

Mr. Ramón Riera Roca joined Grifols in 1977 and served as Chief Commercial Officer as well as being a member of the administration bodies of several companies of the Grifols Group until his retirement on June 30, 2018. Mr. Riera earned a degree in Chemical Sciences from the Autonomous University of Barcelona.

Mr. Ramón Riera Roca is a shareholder of Scranton Enterprises, B.V. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act).

Tomás Dagá Gelabert

Mr. Tomás Dagá Gelabert has served as director of Grifols, S.A. since April 2000 and also as Vice Secretary of the Board since May 2016. He is a partner and founder of the law firm Osborne Clarke in Spain. He was the managing partner of the law firm Osborne Clarke in Spain until June 30, 2017. Prior to joining Osborne Clarke, he worked in the corporate and tax department of Peat Marwick Mitchell & Co. in Barcelona. He is currently a member of the board of directors of Araclon Biotech, S.L., Kiro Grifols S.L., Biomat USA, Inc., Talecris Plasma Resources, Inc., Grifols Diagnostic Solutions Inc., Grifols Worldwide Operations Limited,

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Chiquito Acquisition Corp., Grifols Innovation and New Technologies Limited and PBS Acquisition Corp. He is also a trustee and the secretary of the private foundation Víctor Grífols i Lucas, a trustee of the Probitas Fundación Privada foundation and the secretary non-board member of the board of directors of Progenika Biopharma, S.A. Mr. Dagá earned his law degree from the University of Barcelona (Universidad de Barcelona).

Mr. Tomás Dagá Gelabert is a shareholder of Scranton Enterprises, B.V. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act).

Thomas H. Glanzmann

Mr. Thomas H. Glanzmann has served as a director of Grifols, S.A. since April 2006 and on January 1, 2017 he was appointed non-executive Vice Chairman of the Board of Directors. He is also the General Partner in Medical Technology Venture Partners in California. From 2006 until 2011 he was the CEO and Chairman of Gambro AB. Prior to this Mr. Glanzmann was the CEO and Managing Director of HemoCue AB. Between 1988 and 2004 he held various positions at Baxter Healthcare: Senior Vice President and Corporate Officer of Baxter Healthcare Corporation; President of Baxter Bioscience; Chief Executive Officer of Immuno International; and President of the European Biotech Group. Between 1984 and 1988 he worked at Philip Morris where he was the country manager for Norway, Denmark and Iceland. He also was a senior advisor to the Executive Chairman and a managing director at The World Economic Forum in Davos from 2004 - 2005 and the Chairman of the Plasma Protein Therapeutics Association (PPTA) between 2000 and 2001. Mr. Glanzmann holds an MBA from IMD in Switzerland, a B.A. in Political Science from Dartmouth College, USA. and a Board of Directors Certification from the UCLA Anderson School of Management, USA.

Anna Veiga Lluch

Ms. Anna Veiga Lluch has served as a director of Grifols, S.A. since December 2008. She was awarded a B.S. in Biological Sciences and received a Ph.D. in Biology (cum laude) from the Universidad Autónoma de Barcelona. She specializes in clinical embryology, reproductive genetics, embryonic and pluripotent stem cells research and bioethics. She was the IVF laboratory Director at the Reproductive Medicine Service at Institut Universitari Dexeus from 1982 to 2005. She is currently the Director of the Stem Cell Bank at the Barcelona Centre for Regenerative Medicine, the Director of the Research and Development Biological Area of the Reproductive Service of the Institut Universitari Dexeus, and an associate professor at the Department of Experimental and Health Services of the Universidad Pompeu Fabra in Barcelona. She is also a member of the Board of Trustees of the Foundation Dexeus Women’s Health of Barcelona and an honorific member of the Institut Medico Farmacèutic de Cataluña. In 2004 she was awarded the Creu de Sant Jordi by the Generalitat de Catalunya, and in 2013 she received the Medal of Honour from the Catalan Parliament. In May 2015, she was awarded the degree of Doctor Honoris Causa from the Universitat Central de Catalunya.

Steven F. Mayer

Mr. Steven F. Mayer has served as a director of Grifols, S.A. since January 2011. He is currently the CEO of Iron Horse Acquisition Corp. and of Dedication Capital, LLC, private investment firms that he founded. From 2002 until 2018, he held a variety of senior positions with Cerberus Capital Management, L.P. and Cerebus California, LLC, affiliated private investment firms, culminating with serving as Senior Managing Director, Co-Head of Global Private Equity, and Chairman of the Cerberus Investment Committee.

Mr. Mayer holds Bachelor in Arts (cum laude) from Princeton University and a law degree (magna cum laude) from Harvard Law School. Mr. Mayer has served as a member of the board of directors or equivalent body of a large number of companies in a wide variety of industries in the United States and Europe, and is currently a member of the Board of Supervisors of Syntellix AG.

Luís Isasi Fernández de Bobadilla

Mr. Luís Isasi Fernández de Bobadilla has served as a director of Grifols, S.A. since May 2011. He is Managing Director of Morgan Stanley in Spain and Country Head for the Iberia region. He joined Morgan Stanley in London in 1987. Prior to that, he served as executive director at First Chicago Ltd. in London and, previously, worked in New York for the Latin American department of Morgan Guaranty Trust Co. Mr. Isasi started his professional career in Abengoa, in Seville (Spain) in 1977. Mr. Isasi has a Bachelor’s Degree in Business and Economics from the University of Seville, and holds an MBA from Columbia Business School.

Belén Villalonga Morenés

Ms. Belén Villalonga Morenés has served as a director of Grifols, S.A. since May 2013. She is a Professor of Management at New York University’s Stern School of Business. Between 2001 and 2012 she was a faculty member at Harvard Business School. She serves as an independent director at Acciona, a leader in the renewable energy and infrastructure businesses, since 2006. She was also

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an independent director and President of the Strategy Committee at Talgo, a high-speed train manufacturer, until July of 2018. She is also a Senior Associate Partner at Cambridge Advisors to Family Enterprise, a family business consulting company. Her teaching, research, and consulting activities are in the areas of corporate strategy, finance, and governance, with a special focus on family-controlled companies. Her award-winning research, which has been published in the top academic journals, has been cited extensively in academic articles and in the international media. She holds a Ph.D. in Management and an M.A. in Economics from the University of California at Los Angeles, where she was a Fulbright Scholar. She also holds a second Ph.D. in Business Economics from the Complutense University of Madrid and a B.A. in Economic and Management Sciences from the Colegio Universitario de Estudios Financieros in Madrid. Before starting her doctoral studies, she worked at McKinsey & Co. in Paris.

Marla E. Salmon

Ms. Marla E. Salmon has served as a director of Grifols, S.A. since May 2014. She is a Professor at the University of Washington (USA), with appointments in nursing, global health, and public policy and governance. Her career has focused on health policy and capacity building in both global and U.S. contexts, working with governments, international agencies and other health-related entities. Her recent work focuses on social enterprise and development in the health sector.

Ms. Salmon currently serves on the governing boards of IES Abroad, Inc., and The One City Project. Previous board service includes the Robert Wood Johnson Foundation and the National Center for Healthcare Leadership. She has also served on the White House Task Force on Health Care Reform, the Commission to Build a Healthier America, the World Health Organization’s Global Advisory Group on Nursing and Midwifery, and the National Institutes of Health National Advisory Committee for the Institute of Nursing Research.

Ms. Salmon holds a doctorate in health policy and administration from Johns Hopkins University, degrees in political science and nursing from the University of Portland, and was a Fulbright Scholar at the University of Cologne (Germany). She holds two honorary doctoral degrees recognizing her national and international service, and is a member of the National Academy of Medicine.

Carina Szpilka Lázaro

Ms. Carina Szpilka Lázaro has served as a director of Grifols, S.A. since May 2015. She earned a degree in Business Administration from the Universidad Pontificia de Comillas in Madrid (ICADE) and an Executive MBA from the Instituto de Empresa de Madrid. She began her professional career in the financial sector working at Banco Santander and Argentaria (now part of BBVA). In 1998 she was part of the team that founded ING Direct in Spain, where she held the position of CEO from 2010 to 2013, having previously held that position in ING Direct France from 2008 to 2010. She is currently an independent director at Abanca and Meliá Hotels International, as well as a partner at KFund Venture Capital and Chairwoman of Adigital. In 2011 she was given the “Female Executive of the Year” award by the Spanish Federation of Female Directors, Executives, Professionals and Entrepreneurs (Federación Española de Mujeres Directivas - FEDEPE).

Iñigo Sánchez-Asiaín Mardones

Mr. Iñigo Sánchez-Asiaín Mardones has been the Lead Independent director of the Board since May 2015. He earned a degree in Business Administration from the Universidad Pontificia de Comillas in Madrid (ICADE) and an MBA from Harvard Business School. In 2010 he founded Portobello Capital, where he remains a partner and a member of the Executive Committee and Investment Committee at Portobello Capital. Mr. Sánchez-Asiaín has used his position at Portobello Capital to spearhead investments in companies in which he is Chairman and member of the Executive Committee, such as Angulas Aguinaga or Multiasistencia. Previously, from 1993 to 2005, he was Deputy General Director at Banco Santander and from 2005-2010 was a partner and member of the board of directors of Ibersuizas Gestión SGECR, S.A. He is also a member and former chairman of the Executive Committee at the Harvard Club of Spain.

Biography of the Secretary Non-Member of the Board

Nuria Martín Barnés

Ms. Nuria Martín Barnés served as Vice-Secretary Non-Member of the Board of Directors from 2001 to 2015, and has served as Secretary Non-Member of the Board of Directors since 2015. Ms. Martín has been the managing Partner at Osborne Clarke Spain since July 1, 2017. Prior to joining Osborne Clarke she worked in the Corporate and Tax Department of KPMG Peat Marwick from 1982 to 1986. Ms. Martín is also secretary and member of the board of directors of Compañía General de Inversiones, S.I.C.A.V., S.A., Gesiuris Asset Management, S.G.I.I.C., S.A., CAT Patrimonis, S.I.C.A.V., S.A., URC Patrimonis, S.I.C.A.V., S.A. and Technetix Spain, S.L. Ms. Martín earned her law degree from the University of Barcelona.

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Senior Management

Our senior management currently consists of the following persons:

Name |  | Age |  | Title |  | Since
Raimon Grifols Roura |  | 55 |  | Co-CEO |  | 2017
Víctor Grifols Deu |  | 42 |  | Co-CEO |  | 2017
Alfredo Arroyo Guerra |  | 61 |  | Chief Financial Officer |  | 2013
Miguel Pascual Montblanch |  | 59 |  | President, Commercial Operations Support |  | 2018
Vicente Blanquer Torre |  | 58 |  | VP Quality and Regulatory Affairs |  | 2016
Mateo Florencio Borrás Humbert |  | 63 |  | Chief Human Resources Officer |  | 2013
Gregory Gene Rich |  | 67 |  | President and Chief Executive Officer of Grifols Shared Services North America, Inc. |  | 2015
David Ian Bell |  | 64 |  | General Counsel and Chief Innovation Officer |  | 2016
Nuria Pascual Lapeña |  | 55 |  | VP, CORP Treasury & Investor Relations |  | 2015
Lafmin Morgan |  | 54 |  | Chief Commercial Officer |  | 2018
Carsten Schroeder |  | 53 |  | President of the Diagnostic Commercial Division |  | 2018
Jose Oriol Duñach Fulla |  | 62 |  | President of the Diagnostic Industrial Group |  | 2013
Eduardo Herrero Jiménez |  | 50 |  | President of Bioscience Industrial Group |  | 2017
Daniel Fleta Coit |  | 48 |  | Chief Industrial Officer |  | 2019
Robert Jagt |  | 53 |  | President of the Hospital Commercial Division |  | 2018
Luis Twose Garçon |  | 42 |  | Managing Director Laboratorios Grifols |  | 2018
Joel Abelson |  | 60 |  | President of the Bioscience Commercial Division |  | 2018
Alberto Grifols Roura |  | 60 |  | President of the Bio Supplies Division |  | 2018
Matt Murawski |  | 53 |  | VP, Diagnostic Research and Innnovation & Project Management |  | 2017
Maria Teresa Rioné Llano |  | 54 |  | VP, Corporate Communications |  | 2018
Albert Grifols Coma-Cros |  | 41 |  | President, Grifols Worldwide Operations |  | 2018
Xavier Sueiras Gil |  | 50 |  | Chief IT Officer |  | 2018

Senior Management Biographies

The following are the biographies of our senior management who are not also directors:

Alfredo Arroyo Guerra

Mr. Arroyo has served as our Corporate Vice President and Chief Financial Officer since January 2007. Previously, Mr. Arroyo served as a CFO and in various Senior Finance positions in companies including KPMG, Carrefour, Chupa Chups, Reckitt Benckiser and Winterthur. Mr. Arroyo received a degree in Economics and is a Certified Public Accountant in Spain.

Miguel Pascual Montblanch

Mr. Pascual has served as our President Commercial Operations Support (previously President Operations Network) since 2012 and he is also a member of the board of worldwide Grifols commercial affiliates. He joined us in 1974 and has held several positions since that time, beginning as General Manager of Grifols Movaco S.A. until 2007. He was also General Manager of Iberoamerica Sales from June 2007 until 2012.

Vicente Blanquer Torre

Mr. Blanquer has served as our VP Quality and Regulatory Affairs since 2007 and was Corporate Vice President and the Technical Director of the Biological Industrial Group (previously the Pharmaceutical Technical Director) since 1993. He is responsible for both Bioscience’s quality assurance and quality control. From 1987 until 1993, he was the Deputy Technical Director, responsible for process quality control concerning plasma derivatives manufacturing. Mr. Blanquer received a degree in Pharmacy from the University of Barcelona.

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Mateo Florencio Borrás Humbert

Mr. Borrás has served as our Corporate Vice President and Chief Human Resources Officer (previously Director of Global Human Resources) since 2008. Previously, he served as a HR Director at various companies, including EMAYA, Nissan Motor Ibérica and others. He is a member of AEDIPE (Spanish Association of People Management and Development, of which he has also been Chairman) and he is an Arbitrator at the Arbitrator Corps of Catalonian Labor Court. Mr. Borrás received a degree in Psychology and a Postgraduate on Labor and Social Security, both at the University of Barcelona.

Gregory Gene Rich

Mr. Rich has served as President and Chief Executive Officer of Grifols Shared Services North America, Inc. (previously Grifols, Inc.) since December 2001. Previously, he held these positions in Grifols, Inc. Prior to working with us, Mr. Rich worked for Grupo Picking Pack, as Chief Operating Officer from December 2000 to December 2001 and from July 1997 to August 2000, as Senior Vice President for Green Cross International, the then parent of Alpha. Mr. Rich also worked for Alpha as Vice President and General Manager of International Operations from October 1995 to July 1997. In between his two terms at Alpha, Mr. Rich worked for us from January 1983 to October 1995 and served as our co-President for the period December 1985 through his departure in 1995. Mr. Rich earned a Bachelor’s of Science degree from California Polytechnic University, Pomona.

David Ian Bell

Mr. Bell has been the General Counsel NA since 2003 and Chief Innovation Officer since 2016. Mr. Bell joined us as a Corporate Vice President of Grifols Shared Services North America, Inc. (previously Grifols, Inc.) in July 2003. He also serves as a member of our Executive Committee in Spain. He additionally serves on the boards of numerous companies affiliated to Grifols. Mr. Bell is responsible for all legal activities of our U.S. operations, including litigation, mergers and acquisitions, real estate transactions, intellectual property and contracts. He is also responsible globally for the innovation activities of the Company. Prior to joining us, Mr. Bell was Vice President and General Counsel for Alpha. He also spent time as a partner at the U.S. law firm of Knapp, Petersen & Clarke where he specialized in complex litigation involving healthcare, pharmaceutical and biotechnology regulation and liability. Mr. Bell attended the University of California, Irvine, Southwestern University School of Law and a postgraduate program at Harvard Law School. He is a member of the California State Bar and is admitted to practice before the United States Supreme Court as well as numerous federal appellate and district courts.

Nuria Pascual Lapeña

Ms. Pascual joined us in 1996. She currently serves as VP, CORP Treasury & Investor Relations. Prior to joining us, she served in various positions at Deutsche Bank and Banco Santander de Negocios. She is a member of the board of directors of several companies related to her family’s businesses. Ms. Pascual received a degree in Economics & Business Administration and received a Masters of Sciences in Economics from the London School of Economics and Political Sciences.

Carsten Schroeder

Mr. Schroeder became President of the Grifols Diagnostic Commercial division in 2014. Prior to joining Grifols, Mr. Schroeder was president of Novartis Diagnostics, where he led growth in the global Transfusion Medicine market and oversaw improvements in manufacturing, quality, and commercial operations. At Novartis, Mr. Schroeder was a member of the Vaccines & Diagnostic Division Executive Committee and served as site head for the Company’s Emeryville campus. He joined Novartis Diagnostics in 2010 as Vice President of Commercial Operations for the EMEA region. Mr. Schroeder has held executive positions with Boston Scientific and positions of increasing responsibility at Mallinckrodt (now Covidien) and Boehringer Ingelheim. Mr. Schroeder holds an MBA from the European School of Management in Paris (ESCP) and a Bachelor of Arts in Economics from the University of Cologne in Germany.

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Lafmin Morgan

Mr. Morgan has been Chief Commercial Officer since July 2018 and had been President of the Global Bioscience Division for Grifols since 2014. Previously, Mr. Morgan led the Global Marketing function for all Grifols divisions, Bioscience, Hospital and Diagnostics. Mr. Morgan also served as Grifols North American Vice President and General Manager for Pulmonary in 2011. Mr. Morgan joined Grifols (then Talecris) in 2010. He was the Vice President of Product Management at Talecris Biotherapeutics where he was responsible for the marketing of Gamunex-C, Prolastin-C, Thrombate, Koate —DVI and the company’s line of Hypermune products. Prior to Grifols, Mr. Morgan worked at GSK for 20 years. During that time, he held a variety of positions in a number of different functional areas. Mr. Morgan holds a Bachelor’s Degree in Business Administration and an MBA from the University of North Carolina in Chapel Hill.

Jose Oriol Duñach Fulla

Mr. Duñach joined us in 1985 and has held several positions since that time, starting as Sales Manager Deputy, later Diagnostic Division Manager and finally acting as General Manager of Diagnostic Grifols S.A. from 1987 to 2013. Since 2013, Mr. Duñach has served as President of the Diagnostic Industrial Group. Beginning in 2015, he has also been Managing Director of Medion Diagnostic A.G. Mr. Duñach is a member of the board of Fenin, the Spanish association of Medical Device Manufacturers. Mr. Duñach received a degree in Organic Chemistry from the University of Barcelona in 1979.

Luis Twose Gar ç on

Mr. Twose joined us in 2002 and has held several positions since that time, progressing from project engineer in Grifols Engineering, S.A. to director of the manufacturing plant in Parets (Spain) of Laboratorious Grifols S.A. and acting later as Deputy Managing Director of Laboratorios Grifols S.A. Since July 2018, Mr. Twose has served as Managing Director of Laboratorios Grifols S. A. Mr. Twose received a degree in Industrial Engineering from the Universitat Politècnica de Catalunya in 2001.

Daniel Fleta Coit

Mr. Fleta joined us in 2001 and since January 2019 he has been our Chief Industrial Officer. Previously, Mr. Fleta served as Deputy Chief Industrial Officer and Managing Director Grifols Engineering S.A. from 2011 to 2018. Beginning in 2005, he has served as Director Pharmaceutical Projects. Mr. Fleta received a degree in Industrial Engineering from the Institut Químic de Sarrià in 1995.

Eduardo Herrero Jimenez

Mr. Herrero joined us in 1998 and since January 2018 he has been our President Bioscience Industrial Group. Previously, Mr. Herrero served as President and Managing Director of Biomat, S.A. from 2009 to 2015. Beginning in 2002, he had served as Manager Regulatory Affairs. Mr. Herrero received a Master’s Degree in Pharmacy from the Universitat Politècnica de Barcelona in 1991.

Robert Jagt

Mr. Jagt joined us in 2014 as Vice President Commercial Services and since July 2017 he has been our President of Hospital Commercial division (previously President Hospital Operations Network). Previously, Mr. Jagt served as Vice President Bioscience Commercial Services & Controlling. Mr. Jagt holds a Bachelor of Arts, Business & Economics from Wheaton College, Illinois.

Joel Abelson

Mr. Abelson joined us in 2006 and since 2018 he has been our President Bioscience Commercial division. Previously, Mr. Abelson served as President Global Bioscience Sales & Commercial Operations and Corporate Vice President Commercial NA Operations from 2013 to 2016. Beginning in 2011, he has served as President NA Commercial Operations. Mr. Abelson holds a Bachelor of Arts from the Carleton University in Ottawa and a Master’s in Public Administration from the University of Toronto.

Alberto Grifols Roura

Mr. Grifols joined us in 1985 and since 2018 has served as President Bio Supplies division. Previously he has held several positions, such as; Managing Director of Grifols Argentina S.A., Managing Director of Biomat S.A., Managing Director of Laboratorios Grifols; and President Instituto Grifols, S.A. from 2011 to 2016. Mr. Grifols received a Master’s degree in Industrial

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Engineering from the Universitat Politècnica de Terrassa in 1985.

Matt Murawski

Mr. Murawski joined us in 2007 as Vice President of both Diagnostic Research and Innovation Management and Project Management. Previously, he was the senior executive responsible for business alliances and project execution at Hologic where he coordinated and monitored diagnostic innovation projects, including internal and external investments. Mr. Murawski holds a Bachelor of Science, Finance and a Master’s in Business Administration from DePaul University - Kellstadt School of Business.

Maria Teresa Rioné Llano

Ms. Rioné joined Grifols in 2018 as Vice President of Corporate Communications. Prior to Grifols, Ms. Rioné was Senior Director of Communications Western Europe at Nike Corporation. Ms. Rioné is a graduate in Law with honors in Commercial Law from Universitat de Barcelona and a Master’s in Marketing and Sales Management from IE Business School.

Albert Grifols Coma-Cros

Mr. Grifols Coma-Cros joined Grifols in 2004 and since 2018 serves as President at Grifols Worldwide Operations Limited on a full-time basis. He previously held positions with us as Corporate Cash Manager and Global Treasury Director, a job that he has combined with his position in Global Treasury since October 2016. Mr. Grifols Coma-Cros received a degree in Business Administration from the Universitat Autònoma de Barcelona in 2004.

Xavier Sueiras Gil

Mr. Sueiras joined us in 1997 and has held several positions since that time, starting as Manufacturing Director in Laboratorios Grifols, S.A., later becoming Project Director from 2005 to 2012 in Grifols, S.A. and then working as VP NA Information Technology and VP Global IT from 2012 to 2015. Since 2018, Mr. Sueiras has served as Chief IT Officer. Mr. Sueiras received a degree in Industrial Engineering from the Universitat Politècnica de Catalunya in 1994.

Family Relationships

Mr. Raimon Grifols Roura, director and one of our Chief Executive Officers, Mr. Alberto Grifols Roura, President of Bio Supplies division and Mr. Víctor Grifols Roura, a director and non-executive Chairman of the Board, are brothers.

Mr. Raimon Grifols Roura is the uncle of Mr. Víctor Grifols Deu, both being directors and co-Chief Executive Officers.

Mr. Alberto Grifols Roura, the President of Bio Supplies division, is the uncle of Mr. Victor Grifols Deu, one of the co-Chief Executive Officers.

Mr. Víctor Grifols Deu, director and one of our co-Chief Executive Officers, is the son of Mr. Víctor Grifols Roura, a director and the non-executive Chairman of the Board.

Messrs. Víctor Grifols Roura, Alberto Grifols Roura and Raimon Grifols Roura are the grandchildren of Mr. José Antonio Grifols i Roig, our founder.

Mr. Raimon Grifols Roura, director and one of our Chief Executive Officers, Mr. Alberto Grifols Roura, President of Bio Supplies division and Mr. Victor Grifols Roura, a director and non-executive Chairman of the Board, are cousins of Mr. Albert Grifols Coma-Cros, the President of Grifols Worldwide Operations.

Arrangements Pursuant to Which Certain Directors or Senior Management Were Selected

The following is a description of all arrangements or understandings with major shareholders, customers, suppliers or others pursuant to which any person named above was appointed.

Pursuant to the terms of the Merger Agreement, we agreed to appoint two individuals designated by Talecris to our Board, upon consummation of the Talecris acquisition, each for a five-year term. Mr. Mayer is the only current director that was designated for such appointment and was appointed as a director in June 2011 and reelected in 2016, from such year under the category of independent director.

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B. Compensation

Compensation of Members of the Board

Our directors are entitled to receive compensation for serving as directors on our Board. The Articles of Association generally set forth the processes for the determination of the compensation paid to the members of the Board. Article 20.bis of the Articles of Association provides that the directors’ remuneration shall be a fixed amount and that, at least every three years and valid for the three fiscal years following the year it is approved, the general shareholders’ meeting shall approve the directors’ remuneration policy, which, pursuant to Article 26 of the Regulations of the Internal Functioning of the Board of Directors of Grifols, S,A. (reglamento de funcionamiento interno del consejo de administración), or Board Regulations, (i) with respect to directors in their condition as such shall necessarily determine the maximum amount of the annual remuneration to be paid to all the directors and (ii) with respect to the remuneration of the directors for performing their executive duties must include the amount of the annual fixed remuneration, the different parameters to set the variable components and the main terms and conditions of their contracts including, in particular, duration, severance payments or compensations for the termination of the employment relationship, and exclusivity, post-contractual non-competition, and retention or loyalty agreements. The Board then determines, pursuant to Article 26.2 of the Board Regulations, how much of the shareholder-approved aggregate compensation amount will be allocated to each director as compensation, taking into account the recommendations of our appointments and remuneration committee (comisión de nombramientos y retribuciones), or Appointments and Remuneration Committee, and their dedication to our business. In this respect, the Company’s director remuneration policy is the one which was approved at the general shareholders’ meeting held on May 26, 2017 and which is applicable during three fiscal years following the year of its approval.

Our director compensation philosophy, as set forth in Article 27 of the Board Regulations, provides that the remuneration of non-executive directors (consejeros no ejecutivos) shall be established in a manner that provides incentives for our directors to be dedicated and involved while not creating an obstacle to their independence. To that end, Article 27 further establishes that the Board, following the advice of the Appointments and Remuneration Committee, shall take the necessary measures to ensure that non-executive directors’ remuneration adheres to the following guidelines: (a) their remuneration should be relative to their dedication, abilities and functions; and (b) they are excluded from any plans (x) consisting of the delivery of equity awards or options or other instruments linked to the value of our shares, (y) linked to our performance or (z) including retirement benefits. However, non-executive directors may be remunerated with our shares only if they agree to hold them for the duration of the term that they hold their office.

In accordance with the compensation system outlined in the Articles of Association and the new Company’s directors’ remuneration policy, adopted at the general shareholders’ meeting held on May 26, 2017, which is applicable during three fiscal years following the year of its approval, the shareholders set the maximum annual amount available for compensation to the non-executive directors at €100,000 per director, other than those non-executive directors of the Board that render remunerated professional services to us. Also, any director that is a member of one of the Board committees (Audit Committee and Appointments and Remuneration Committee) shall receive an additional gross annual remuneration of €25,000 as a result of the heavier workload (thus, the total remuneration would amount to €125,000). Similarly, the chairpersons of each Committee would receive an additional €25,000 for performing their duties as chairperson (thus, the total remuneration would amount to €150,000). The lead independent director would receive an additional remuneration amounting to €50,000 for performing his/her duties (thus, the total remuneration would amount to €150,000). Under no circumstances may the remuneration of a non-executive director exceed €150,000 per year.

As a result, in 2018, the following directors received compensation in their condition as such, namely, Ms. Anna Veiga Lluch, Mr. Steven F. Mayer, Mr. Luís Isasi Fernández de Bobadilla, Ms. Belén Villalonga Morenés, Ms. Marla E. Salmon, Ms. Carina Szpilka Lázaro and Mr. Iñigo Sánchez Asiaín Mardones.

As of the date of this annual report on Form 20-F, Ms. Anna Veiga Lluch, Mr. Luís Isasi Fernández de Bobadilla, Mr. Steven F. Mayer, Ms. Belén Villalonga Morenés, Ms. Marla E. Salmon, Ms. Carina Szpilka Lázaro and Mr. Iñigo Sánchez-Asiaín Mardones are our independent directors in conformity with Exchange Act requirements and NASDAQ Listing Rules. Messrs. Dagá, Glanzmann and Riera serve as external directors (and not independent) and Mr. Víctor Grifols Roura serves as proprietary director (and not independent) in conformity with Spanish rules.

The total compensation paid to directors in 2018, in the aggregate, amounted to €6.7 million. Of the total director compensation amount, the executive directors (consejeros ejecutivos) and Mr. Ramón Riera Roca, who was an executive director until June 30, 2018, received €2.8 million (€1.8 million in fixed compensation in cash and €976 thousand in variable compensation in cash for their service as executive directors). It must be noted that Mr. Ramón Riera Roca, who was an executive director until June 30, 2018, and the executive director Mr. Víctor Grifols Deu’s RSUs allocated in fiscal year 2016, had a vesting period of 2 years and 1 day, and vested in 2018. Consequently, in 2018 both of them were awarded Class B shares with an equivalent value of €476 thousand and €44 thousand, respectively. External directors (other than those who render remunerated professional service to us) received €844 thousand. These figures include accruals for contingent or deferred compensation. None of our directors received attendance fees for

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meetings of the Board or committees of the Board. Finally, pursuant to Article 20.bis of the Articles of Association, our directors are reimbursed for all expenses incurred in connection with their service as directors.

With respect to the €976 thousand received by the executive directors and Mr. Ramón Riera Roca in variable compensation, this amount corresponds to 50% of the total amount of variable compensation in the case of the executive directors. The remaining 50% was paid in Class B ordinary shares with a vesting period for delivery of two years and one day. Mr. Ramón Riera received all of the variable compensation in cash.

The remuneration of the Chairman of the Board for year 2018 was a fixed annual amount of €965 thousand, as established under the Company’s directors’ remuneration policy. The Chairman of the Board will no longer receive a variable remuneration. The remuneration of Mr. Grifols has been determined taking into account his proven experience as director and Chairman of the Company, in addition to his knowledge in the sector where the Company operates. When deciding the remuneration of Mr. Grifols, which is the same fixed amount he had when he held an executive position, excluding any variable amount, the additional duties that he will carry out, as well as those set out in the Spanish Companies’ Act for the position of Chairman of the Board, were taken into account.

Additionally during 2018, the Chairman received payment for his executive role in certain activities in prior years. In March 2018 he received RSUs allocated in fiscal year 2016, which had a vesting period of 2 years and 1 day. Hence, in 2018 he was awarded Class B shares with an equivalent value of €645 thousand.

Compensation of Senior Management

In 2018, members of our senior management (excluding those who also served as members of the Board) were paid compensation amounting to €16,070,290 in the aggregate. This figure includes accruals for contingent or deferred compensation earned in respect of 2018 service. The breakdown of the aggregate amount paid to such senior management for discharging their duties in 2018 is set forth in the table below.

Component |  | Amount Paid in 2018 |
Salaries |  | € | 9,692,114 |
Variable Compensation |  | € | 6,378,176 |
Stock options or other securities |  | — |
Other — e.g., life and health insurance |  | € | 106,713 |
Other — e.g., pensions/savings |  | € | 61,016 |

The above variable compensation includes €3,427,611 in RSUs allocated in fiscal year 2016, which had a vesting period of 2 years and 1 day, and have vested in 2018.

Salaries paid in U.S. dollars have been calculated at the exchange rate between the U.S. dollar and the euro of U.S. $1.1533 to €1.00.

The Company has established a Restricted Share Unit Retention Plan, or RSU Plan, for eligible employees. Under the RSU Plan, an employee can elect to receive up to 50% of their yearly bonus in non-voting Class B shares or ADSs, and we will match their RSUs with an additional 50% of such employee’s election of RSUs, or Additional RSUs. Our Class B shares and ADSs are valued at the date of payment of the bonus such employee has elected to receive and no cash dividends will be paid with respect to these shares. These RSUs will have a vesting period of two years and one day and will subsequently be exchanged for Class B shares or ADSs representing Class B shares. If an eligible employee leaves the Company, or is terminated before the end of the vesting period, they will not be entitled to the Additional RSUs. This commitment is treated as equity-settled and the total amount was €12,652,000. At December 31, 2018, the Company had settled the RSU Plan for an amount of €7,914,000.

Equity and Other Incentive Programs

In 2018, no compensation was paid pursuant to a profit sharing plan or any stock option and no other equity compensation was awarded to any of our directors or senior management.

Pension and Retirement Compensation Programs

Our directors and senior management employed by our U.S. subsidiaries participate in a tax-qualified 401(k) plan on the same terms as our other employees. The aggregate amount of employer contributions to the 401(k) plans for our directors and senior

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management during 2018 was €49,423.39 or $57,000,000. In addition, the Company made contributions to the pension plan of one member of senior management who resides in Canada, in the amount of €11.593 or CAD17.723. In 2018, neither we nor our subsidiaries set aside or accrued any other amounts to provide pension, retirement or similar benefits for our directors or senior management.

C. Board Practices

Board of Directors

Pursuant to the Articles of Association, we are managed by a Board, which may be composed of not less than three and not more than 15 directors. Our current Board has 13 directors. Directors may be either individuals or legal entities represented by individuals. Under Spanish law, the Board is responsible for management, administration and representation in all matters concerning the business, subject to the provisions of the Articles of Association and the powers conferred at the general shareholders’ meeting.

Appointment and Dismissal

Pursuant to Spanish law and our Articles of Association, directors are elected by our shareholders to serve for a term of four years and may be reelected to serve for an unlimited number of terms, except in the case of independent directors, who pursuant to Spanish Law and the Board Regulations, shall not serve as such for more than 12 years. We do not provide for the reelection of directors at staggered intervals or cumulative voting for such directors or otherwise.

A director may either be an individual or an entity represented by an individual. If a director ceases to hold office prior to the expiration of his or her term, the Board may fill the vacancy by appointing a new director to replace the outgoing director. Any director so appointed will hold office until the next general shareholders’ meeting when the appointment may be confirmed or revoked by our shareholders. If such appointment takes place between the time that a general shareholders’ meeting is called and the time the meeting takes place, then the director so appointed will hold office until the next general shareholders’ meeting, when this appointment is to be confirmed or revoked. Any such appointment will be only for the remainder of the term of the outgoing director, without prejudice to such director’s eventual election. A director may resign, or be removed, from office by a resolution of our general shareholders’ meeting at any time. A director who is also a shareholder may vote freely on any of our shareholders’ resolutions relating to the appointment and dismissal of directors (including the appointment or dismissal of that director).

In addition, pursuant to the Board Regulations, a director must tender a resignation to the Board and the Board may accept such resignation, in its discretion, under the following circumstances: (i) when the director ceases to hold the executive position to which such director’s appointment to the Board was related; (ii) when the director becomes unable to hold the office due to a legal cause of ineligibility or incompatibility; (iii) when the director has been formally charged with certain crimes (including, but not limited to, crimes against personal freedom, economic crimes and crimes against the justice administration) or a formal inquiry is opened against him or her by a regulator; (iv) when the director has been severely admonished by our Audit Committee for having breached his or her duties as director; (v) when the director’s participation on the Board may jeopardize our interests or when the reasons for his or her appointment cease to exist; and (vi) in the case of a proprietary director, when the relevant shareholder ceases to hold its stake in us, or reduces its stake below the level that reasonably justified the appointment of such director.

In addition, under Spanish corporate law, a holder of voting shares (or group of shareholders of voting shares acting together) may, subject to availability of seats on the Board, appoint a number of directors proportionate to that shareholder’s (or group of shareholders’) interest in our voting capital. If the voting capital stock represented by the shares held by such shareholder (or group of shareholders) is equal to or greater than the result of dividing our total voting capital stock by the number of directors, such shareholder (or group of shareholders) shall have the right to appoint a proportionate number of directors. For example, a shareholder holding 20 voting shares out of a total of 100 voting shares in a company with five directors will be entitled to appoint one director. Should this power be exercised, shares so pooled shall not participate in the voting for the other members of the Board. However, they may exercise their voting rights with respect to the removal of existing directors. Since such rights apply only to voting shares or Class B shares that have recovered their voting rights, our Class B shares and the Class B ADSs that represent them in the United States do not count towards the proportional representation right.

The Board must appoint a Chairman of the Board from among its members. Mr. Víctor Grifols Roura is the current non-executive Chairman. The Board may also designate one or more Vice Chairmen, who shall be numbered consecutively, and who shall replace the Chairman in the event of impossibility to act or absence. Mr. Thomas Glanzmann is the current Vice Chairman.

The Board must also appoint a Secretary and may also designate one or more Vice-Secretaries. Neither the Secretary nor the Vice-Secretary is required to be a member of the Board; however, the Secretary or the Vice-Secretary will not be entitled to vote on

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matters before the Board unless he or she is a member of the Board. Mr. Tomás Dagá is the current Vice-Secretary of the Board and Ms. Nuria Martín Barnés is the current Secretary non-member of the Board.

Meetings of the Board

Pursuant to the Articles of Association, a meeting of the Board may be called by the Chairman whenever he considers such a meeting necessary or suitable. The Chairman is also required to call a meeting at the request of one-third of the directors. Meetings of the Board are called using any means of notice at least ten days before the date of the meeting, unless exigent circumstances require a shorter term. Such notice of a meeting of the Board must state the place, date and time as well as the issues to be discussed. The Board is required by Spanish law to hold a meeting at least every three months. Our Articles of Association provide that a majority of the directors (half plus one of the directors present at a meeting) of the Board (represented in person or by proxy by another director on the Board) constitutes a quorum. Except as otherwise provided by law or specified in the Articles of Association, resolutions of the Board must be passed by an absolute majority of the directors present or represented at a meeting, with the Chairman having the right to cast a deciding vote in the event of a tie.

Pursuant to the Articles of Association the Board may hold meetings by videoconference, conference call or by any other distance communication systems as long as said communications take place in real time and therefore, in one sole act, and both the identity of the participating or voting individual and the security of the electronic communications, are properly guaranteed.

Delegation of Powers

Pursuant to Spanish law and our Articles of Association, the Board may delegate its powers either to an executive committee (Comisión Ejecutiva) or to one or more chief executive officers. Spanish corporate law provides that resolutions appointing an executive committee, any chief executive officer or authorizing the permanent delegation of all, or part of, such board of directors’ powers, requires a two-thirds majority of the members of such board of directors and the registration of such resolution in the Spanish Commercial Registry (Registro Mercantil). The Board may also revoke such powers at any time. In addition, when a member of the Board is appointed chief executive officer or vested with executive functions, he/she will need to enter into an agreement with the Company, which shall be approved by a two-thirds majority of the Board. The director in question will have to refrain from participating in the deliberation and voting process of such agreement.

Under Spanish corporate law, a board of directors may also grant general or specific powers of attorney to any person whether or not that person is a director or a shareholder. General powers of attorney must be registered in the Commercial Registry. However, Spanish law provides that the following powers, among others, may not be delegated: (i) the formulation and submission for approval of the yearly financial statements at the general shareholders’ meeting; and (ii) those powers granted to the board of directors by a general shareholders’ meeting (unless otherwise provided in the relevant shareholders’ resolution).

Mr. Raimon Grifols Roura and Mr. Víctor Grifols Deu currently serve as joint and several Chief Executive Officers of the Company, with delegation of all powers legally delegable from the Board.

Expiration of Current Terms

The periods during which our directors and senior management have served in their offices, as well as the date of expiration of each director’s term, are shown in the tables under “— A. Directors and Senior Management” above.

Termination Benefits

We have entered into employment contracts with all members of our senior management that entitle them to unilaterally rescind their employment contracts and receive termination benefits of two to five years’ salary in the event that we undergo a change of control. In addition to this, six members of our senior management are contractually entitled to termination benefits of one to four years’ salary under certain circumstances other than a change of control.

See Notes 29(c) and 31(a) to our audited consolidated financial statements included in this annual report on Form 20-F for further details of the payments received by employees.

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Committees of the Board

The Board has an Audit Committee and an Appointments and Remuneration Committee. The following is a brief description of such committees.

Audit Committee

The Board established an Audit Committee in compliance with Articles 24.bis and 24.ter of the Articles of Association and Article 14 of the Board Regulations.

The regulations applicable to the Audit Committee are set forth in the provisions referred to above, as well as the bylaws of the Audit Committee, which were approved by the Board and the Audit Committee on December 9, 2008. In connection with the Talecris acquisition, at a Board meeting held on May 24, 2011, the Articles of Association and Board Regulations were amended to conform to NASDAQ Listing Rules and to facilitate the listing of our Class B ADSs on NASDAQ. Furthermore, the bylaws of the Audit Committee were modified at a Committee meeting held on March 31, 2015, to adapt them to the requirements imposed by Law 31/2014. In 2017, article 24.ter of the Articles of Association and Article 14 of the Board Regulations concerning the composition and functions of the Audit Committee were amended in order to adequate their content to the latest amendments of the Companies Act introduced by the currently in force Spanish Audit Act.

Pursuant to our Spanish corporate governance requirements and our Articles of Association and the Board Regulations, the Audit Committee consists of a minimum of three directors and a maximum of five directors who are appointed by the Board based on such directors’ knowledge, competence and experience in accounting, audit and risk management matters. All of the members of the Audit Committee must be non-executive directors, and the majority must be independent directors. As a group, the members of the Committee must have the pertinent technical knowledge in relation to the sector of activity of the Company. In addition, all members of the Audit Committee, including the chairman, must meet the independence, experience and other requirements set forth in the Exchange Act and NASDAQ Listing Rules.

The responsibilities of the Audit Committee include:

· reporting to the shareholders at general shareholders’ meetings regarding matters for which the Audit Committee is responsible;

· recommending to the Board the appointment, hiring and replacement of the external auditor regardless of the faculties vested in the general shareholders’ meeting and the Board with regard to the approval of such resolutions under Spanish law;

· oversight of our internal audit department, including selecting its manager, monitoring its budget, receiving periodic information on the department’s activities and ensuring that management takes the conclusions and recommendations of the department’s reports into account;

· setting up and supervising procedures for the receipt, retention and treatment of complaints regarding accounting, internal controls or auditing matters, as well as the confidential and anonymous submission by employees of concerns regarding questionable accounting or auditing matters;

· exercising oversight of the process for gathering financial information and the related internal control system; reviewing the financial statements and the periodic financial statements that should be submitted to the securities regulatory authorities and ensuring that the appropriate accounting standards are followed; reporting to the Board on any change in the accounting standards and on balance sheet and off balance sheet risks;

· receiving information from the auditors including relating to auditor independence and conduct of audits of the financial statements, and issuing on an annual basis a written opinion on the independence of the auditor;

· supervising any transactions entered into with significant shareholders as set forth in the Board Regulations; and

· (i) ensuring compliance with the Internal Code of Conduct of Grifols, S.A. in Matters Relating to the Stock Market, or Stock Market Code of Conduct, the Code of Conduct for Grifols’ Employees, the Board Regulations (each available on our website, which does not form part of this annual report on Form 20-F, at www.grifols.com) and, in general, any other corporate regulations and (ii) making any necessary proposals to improve such regulations.

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The Audit Committee currently consists of Mr. Mayer and Madames Szpilka and Villalonga. Each of the members is independent in conformity with Exchange Act requirements and NASDAQ Listing Rules, as well as in conformity with the Spanish Companies Act. Mr. Tomás Dagá Gelabert serves as Secretary non-member of the Audit Committee.

Appointments and Remuneration Committee

The Board established an Appointments and Remunerations Committee in compliance with Article 24.bis of the Articles of Association and Article 15 of the Board Regulations.

Pursuant to Spanish corporate governance requirements and Article 15 of the Board Regulations, the Appointments and Remuneration Committee is required to consist of between three and five members, all of which must be non-executive directors, which includes at least two independent directors.

The responsibilities of the Appointments and Remuneration Committee include:

· assisting in the nomination of directors, including evaluating potential nominees in light of the level of knowledge, competence and experience necessary to serve on the Board;

· establishing a representation target for the gender that is least represented on the Board and prepare guidelines to achieve said target;

· reporting and making proposals to the Board on the appointment of members to the various committees of the Board and on the persons who should hold the office of Secretary and Vice-Secretary of the Board;

· examining and organizing the orderly and planned succession of the Chairman of the Board and the Chief Executive Officer;

· reporting on proposals for the appointment and removal of any members of senior management made by the Chief Executive Officer;

· making proposals on the remuneration plans for the Board and senior management;

· periodically reviewing the remuneration plans of senior management, including considering their suitability and performance; and

· reporting on transactions in which directors may have a conflict of interest.

Our Appointments and Remuneration Committee is required, pursuant to Spanish corporate governance requirements and Article 15 of the Board Regulations, to consist of between three and five members, all of which must be non-executive directors. Consistent with NASDAQ Listing Rules for foreign private issuers, our Appointments and Remuneration Committee currently consists of Messrs. Tomás Dagá Gelabert, Luís Isasi Fernández de Bobadilla and Ms. Salmon as directors. Each of Ms. Salmon and Mr. Isasi is independent in conformity with Exchange Act requirements and NASDAQ Listing Rules and Mr. Dagá is considered an “Other External” director under the Spanish Companies Act. Ms. Martín Barnés serves as Secretary non-member of the Appointments and Remuneration Committee.

D. Employees

The table below indicates the number of employees by department as of December 31, 2018, 2017 and 2016:

Department |  | 2018 |  | 2017 |  | 2016 |
Manufacturing |  | 17,147 |  | 14,577 |  | 11,400 |
Research & development — technical area |  | 984 |  | 963 |  | 812 |
Administration and others |  | 1,396 |  | 1,112 |  | 1,095 |
General management |  | 254 |  | 230 |  | 238 |
Marketing |  | 184 |  | 187 |  | 168 |
Sales and distribution |  | 1,265 |  | 1,227 |  | 1,164 |
Total |  | 21,230 |  | 18,296 |  | 14,877 |

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The table below indicates the number of employees by geographic region as of December 31, 2018, 2017 and 2016:

Geographic Region |  | 2018 |  | 2017 |  | 2016 |
Spain |  | 3,858 |  | 3,649 |  | 3,430 |
North America |  | 15,330 |  | 13,671 |  | 10,557 |
Rest of the World |  | 2,042 |  | 976 |  | 890 |
Total |  | 21,230 |  | 18,296 |  | 14,877 |

We actively train our employees. The Grifols Academy opened in Spain during the second quarter of 2011. It is a meeting point for advanced training on all processes related to the preparation and production of plasma-derived medicines. In addition, the Grifols Academy serves to actively spread and strengthen the “Grifols’ spirit” that guides employee actions and their understanding of the business. It also acts as a center of technical, scientific and management training for the Group’s personnel, fostering a continued exchange among experts and external bodies, such as professional healthcare associations, hospitals, schools and universities.

The Grifols Academy works closely with the Grifols Academy of Plasmapheresis, which opened in Phoenix, Arizona in 2009. The Grifols Academy of Plasmapheresis has two U.S. campuses, Glendale, Arizona and Indianapolis, Indiana.

Our Spanish employees are represented by two labor unions, the Workers’ Commissions (Comisiones Obreras) and the Workers General Union (Unión General de Trabajadores). The employees of some of our subsidiaries in Spain, Germany, Italy, France and Argentina are covered by collective bargaining agreements. The remainder of our employees are not represented by labor unions. We have not experienced any significant work stoppages in the last 15 years, except for a one-day general strike in Spain in June 2002. We generally consider our employee relations to be good.

We subscribe to an insurance policy that covers death or permanent disability of employees caused by work accidents. All of our employees are covered under this policy. We implemented a defined contribution pension plan in all our Spanish entities beginning on January 1, 2002, which excludes top management and which requires us to make matching payments to these employees. Our contribution to this pension plan was €777,000 in 2018, compared to €725,000 in 2017 and €674,000 in 2016. We also sponsor a savings plan for the benefit of U.S. employees, which qualifies as a defined contribution plan under Section 401(a) of the Internal Revenue Code of 1986, as amended. We make fully vested matching contributions to the savings plan which totaled $20.7 million for 2018, compared to $18.9 million in 2017 and $17 million for 2016. For certain employees in Germany, we have a defined benefit pension plan, as required by statutory law. The pension cost relating to this plan is not material.

E. Share Ownership

For information on the direct, indirect and represented holdings of our current directors and executive officers with respect to our Class A shares as of December 31, 2018 see Item 7 of this Part I, “Major Shareholders and Related Party Transactions — A. Major Shareholders.”

We do not have any agreements, plans or arrangements in effect that provide for the issue or grant of options or shares or securities.

Item 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

A. Major Shareholders

The following table sets forth certain information, including information regarding beneficial ownership of our Class A (voting) shares as of December 31, 2018, for (i) our major shareholders, including, in accordance with applicable Spanish regulations, each person or entity that is known to us to be the beneficial owner of more than 3% of our Class A shares or 1% of our Class A shares in the event of a person or entity domiciled in a tax haven, (ii) each of our directors and (iii) each member of our senior management. As of that date, there were a total of 426,129,798 Class A shares issued and outstanding.

Since our Class A shares are represented through book entries, their exact ownership structure cannot be known, except through the information that the shareholders provide voluntarily or in compliance with applicable regulations, and information provided by the Sociedad de Gestión de los Sistemas de Registro, Compensación y Liquidación de Valores, S.A., or Iberclear, on which the shares are settled and cleared, and its participant entities (entidades participantes).

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Name of Beneficial Owner |  | Number of Ordinary Shares |  | Percentage of Ordinary Shares |
Major Shareholders |  |  |  |  |
Deria S.A.(1) |  | 37,970,661 |  | 8.91 |
Scranton Enterprises B.V.(2) |  | 36,953,048 |  | 8.67 |
Thorthol Holdings B.V.(3) |  | 30,085,532 |  | 7.06 |
Núria Roura Carreras (4) |  | 26,224,374 |  | 6.15 |
Blackrock, Inc. (5) |  | 18,748,942 |  | 4.40 |
Oppenheimerfunds Inc. (6) |  | 13,064,750 |  | 3.07 |
Jupiter Fund Management PLC (7) |  | 12,967,000 |  | 3.04 |
Ako European Long-Only Master Fund Ltd (8) |  | 4,349,404 |  | 1.02 |
Fidelity International Limited (9) |  | 4,364,423 |  | 1.02 |
Directors |  |  |  |  |
Víctor Grifols Roura |  | 880,900 |  | * |
Ramón Riera Roca |  | 338,170 |  | * |
Thomas H. Glanzmann (10) |  | 167,122 |  | * |
Tomás Dagá Gelabert |  | 103,796 |  | * |
Anna Veiga Lluch |  | 200 |  | * |
Luís Isasi Fernández de Bobadilla |  | 200 |  | * |
Víctor Grifols Deu |  | 14,620 |  | * |
Steven F. Mayer |  | — |  | — |
Belén Villalonga Morenés |  | — |  | — |
Marla E. Salmon |  | — |  | — |
Iñigo Sánchez-Asiaín Mardones |  | — |  | — |
Raimon Grifols Roura |  | 2,780 |  | * |
Carina Szpilka Lázaro |  | 1,490 |  | — |
Senior Management |  |  |  |  |
Gregory Gene Rich |  | 239,200 |  | * |
Vicente Blanquer Torre |  | 44,754 |  |  |
David Ian Bell |  | 20,000 |  | * |
Nuria Pascual Lapeña |  | 19,592 |  | * |
Mateo Florencio Borrás Humbert |  | 982 |  | * |
Alfredo Arroyo Guerra |  | — |  | — |
Lafmin Morgan |  | — |  | — |
Carsten Schroeder |  | — |  | — |
Miquel Pascual Montblanch |  | 15,000 |  | * |
Jose Oriol Duñach Fulla |  | 30,418 |  | * |
Eduardo Herrero Jiménez |  | — |  |  |
Daniel Fleta Coit |  | — |  |  |
Robert Jagt |  | — |  |  |
Luis Twose Garçon |  | — |  |  |
Joel Abelson |  | — |  |  |
Alberto Grifols Roura |  | 27,000 |  |  |
Matt Murawski |  | — |  |  |
Maria Teresa Rioné Llano |  | 664 |  |  |
Albert Grifols Coma-Cros |  | 84,000 |  |  |
Xavier Sueiras Gil |  | — |  |  |

* Less than 1%.

(1) The various members of the Grifols Roura family hold their respective shares indirectly through Deria S.A.

(2) Scranton Enterprises B.V. is a corporation whose shares are owned by certain of our directors. Some Grifols family members who are directors or executive officers hold part of their shares indirectly through Scranton Enterprises B.V.

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(3) The various members of the Grifols Gras family hold their respective shares indirectly through Thorthol Holdings B.V.

(4) 26,224,374 Class A shares are held directly by Rodellar Amsterdam B.V., through which Núria Roura Carreras exercises indirect voting rights.

(5) Blackrock, Inc. has indirect voting rights over 18,748,942 of our Class A shares.

(6) Oppenheimerfunds Inc. has indirect voting rights over 13,064,750 of our Class A shares.

(7) Jupiter Fund Management PLC has indirect voting rights over 12,967,000 of our Class A shares.

(8) Ako European Long-Only Master Fund Ltd has indirect voting rights over 4,349,404 of our Class A shares. As of the date of this report, Ako European Long-Only Master Fund Ltd holds less than 1% of Class A shares. As of January 29, 2019, it has indirect voting rights over 4,258,245 of our Class A shares.

(9) Fidelity International Limited has indirect voting rights over 4,364,423 of our Class A shares.

(10) 24,000 Class A shares are held indirectly through Glanzmann Enterprises AG, and 106,000 Class A shares are held indirectly through Opulenta Holdings Ltd.

To our knowledge, we are not controlled, directly or indirectly, by any other corporation, government or any other natural or legal person. We do not know of any arrangements which would result in a change in our control.

Significant Changes in Ownership

In accordance with Spanish reporting requirements, the following transfers of shares were reported to the Spanish National Securities Market Commission (Spanish Comisión Nacional del Mercado de Valores), or (“CNMV”), as of December 31, 2018: Oppenheimer International Growth Fund communicated to the Spanish National Securities Market Commission that on May 21, 2018 its holding of Class A shares fell below 3%.

Fidelity International Limited communicated to the CNMV that on August 20, 2018 its holding of Class A shares fell below 1%. Fidelity International Limited communicated to the CNMV that on October 23, 2018 its holding of Class A shares reached above 1%. Ako European Long-Only Master Fund Ltd communicated to the CMNV that on November 15, 2018 its holding of Class A shares reached above 1%.

Voting Rights

Each of our Class A shares is entitled to one vote, except that the voting rights of Class A shares held in treasury by us or by any of our direct subsidiaries are suspended. Class A shares held by our major shareholders, directors or senior management do not entitle such shareholders to different voting rights.

Our Class B shares generally do not have voting rights, except with respect to certain extraordinary matters which require approval by a majority of outstanding Class B shares, as set forth in Item 10 of this Part I, “Additional Information — B. Memorandum and Articles of Association — Shareholder Rights — Class B Shares — Separate Vote at General Shareholder Meetings on Extraordinary Matters.”

See Item 10 of this Part I, “Additional Information — B. Memorandum and Articles of Association — Shareholder Rights” for further details regarding our Class A shares and Class B shares.

B. Related Party Transactions

Sale of Haema AG and Biotest US Corporation

In December 2018, we sold our 100% stake in Haema AG and Biotest US Corporation to Scranton Plasma B.V., one of our major shareholders and a related party, for a total of $538 million. Scranton Enterprises B.V. financed the purchase in part through a loan from Grifols Worldwide Operations Limited for an initial principal sum of the euro equivalent of $95 million, with an interest rate of EURIBOR plus 200 basis points. As of December 31, 2018, the euro equivalent of $95 million was outstanding on the loan. As of March 31, 2019, the euro equivalent of $95 million was outstanding on the loan.

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We will have the ability to repurchase the shares sold to Scranton Plasma B.V. at any time. Our Plasma Supply Agreement in place with Haema and Biotest has been extended for a 30-year period and we continue to operate the companies’ plasma centers. See Item 5 of this Part I, “Operating and Financial Review and Prospects - A. Operating Results - Factors Affecting Our Financial Condition and Results of Operations - Acquisitions - Acquisition and Sale of Haema AG and Biotest Corporation” above.

Charitable Contributions

In 2018, we contributed to two charitable foundations, the Mr. Víctor Grifols i Lucas Foundation and the Probitas Private Foundation, which were formed by us, and certain of our current officers and directors serve as patrons of the Probitas Private Foundation.

The Mr. Víctor Grifols i Lucas Foundation provides grants to further the study of bioethics. It was created in 1998 with the mission of promoting bioethics through dialogue between specialists in a range of areas. The Víctor Grifols i Lucas Foundation seeks to foster ethical attitudes in organizations, companies and individuals active in the field of human health, offering a discussion platform that provides a forum for the exchange of different perspectives. Mr. Víctor Grifols i Lucas is our former Chief Executive Officer and is the father of both Mr. Raimon Grifols Roura, our Chief Executive Officer, and Mr. Víctor Grifols Roura, a proprietary director and non-executive Chairman of the Board. We contributed €0.4 million, €0.4 million and €0.4 million to the Víctor Grifols i Lucas Foundation in 2018, 2017 and 2016, respectively.

The Probitas Private Foundation provides medical and sanitary assistance to international communities that lack medical and sanitary resources or that have an urgent and essential need for such services due to catastrophes. The Probitas Private Foundation was founded by us in 2008. Messrs. Raimon Grifols Roura, our Chief Executive Officer, and Tomás Dagá Gelabert, one of our directors, are patrons of the Probitas Private Foundation. We contributed €5.4 million, €6.8 million and €4.9 million to the Probitas Private Foundation in 2018, 2017 and 2016, respectively. We contribute to the Probitas Private Foundation an amount equal to 0.7% of our profits before tax each year.

The Jose Antonio Grifols Lucas Foundation provides grants for education and research into the science of plasmapheresis. Additionally, the foundation assists plasma donors who may be unable to care for themselves. We did not contribute to the Jose Antonio Grifols Lucas Foundation in 2015, 2016 and 2017.

Consultant Agreement

In 2011, subsequent to the Talecris acquisition, one of our directors entered into a consulting services contract for a term of three years, pursuant to which he received compensation in the amount of $1.0 million per year with an additional $2.0 million payable upon the fulfillment of certain conditions. In 2015, we extended this contract for a term of two years. In each of 2016, 2017 and 2018 we paid such director $1.0 million pursuant to this agreement. The consulting services contract will not be renewed during 2019.

Loans

We have not extended any advances or loans to members of the Board or key management personnel nor have we assumed any guarantee commitments on their behalf. We also have not assumed any pension or life insurance obligations on behalf of former or current members of the Board or key management personnel.

C. Interests of Experts and Counsel

Not Applicable.

Item 8. FINANCIAL INFORMATION

A. Consolidated Statements and Other Financial Information

Financial Statements

See our audited consolidated financial statements and the related notes starting on page F-1 of this annual report on Form 20-F.

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Legal Proceedings

We are involved in various legal proceedings in the ordinary course of our business. In the event of adverse outcomes of these proceedings, we believe that resulting liabilities will either be covered by insurance or not have a material adverse effect on our financial condition or results of operations.

On February 3, 2017, bioMérieux, S.A and bioMérieux, Inc. filed suit against Hologic, Inc. (“Hologic”), Grifols, and Grifols Diagnostic Solutions Inc. (“GDS”) in the U.S. District Court for the Middle District of North Carolina, alleging infringement of U.S. Patent Nos. 8,697,352 and 9,074,262 by virtue of defendants’ activities with respect to the Procleix HIV-1/HCV Assay®, Procleix Ultrio Assay®, and Procleix Ultrio Plus® products. Hologic and GDS filed a motion to dismiss for failure to state a claim on April 3, 2017. As a result of a claim of improper venue, the case was transferred to the U.S. District Court for the District of Delaware in early 2018. Hologic and GDS are pursuing defenses of failure to state a claim, non-infringement, invalidity, and that the infringement claims are contractually barred. Additionally, Grifols intends to pursue dismissal for lack of personal jurisdiction.

On October 4, 2016, Enzo Life Sciences, Inc. (“Enzo”) filed suit against Hologic in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent No. 6,221,581 by virtue of Hologic’s activities with respect to Progensa®, Procleix®, and Aptima®products. On November 9, 2017, the Court granted Enzo’s motion to amend its complaint to add Grifols and GDS as defendants with respect to the Procleix® products at issue. Hologic and GDS have answered the complaint, alleging non-infringement and invalidity among their defenses. GSA has moved to dismiss for lack of personal jurisdiction. The case schedule has been extended in light of the addition of Grifols-related entities as co-defendants, with Hologic and GDS currently engaged in fact discovery. Trial is scheduled for September 2019.

See note 29(e) to our audited consolidated financial statements included in this annual report on Form 20-F for additional information regarding the legal proceedings in which we are involved.

Antitrust Approval of Talecris-Grifols Merger

On July 20, 2011, the Federal Trade Commission, or FTC, issued a final order, or Consent Order, to settle its May 31, 2011 charges that our acquisition of Talecris was anticompetitive and would have resulted in higher prices for consumers. Pursuant to the Consent Order, we divested to Kedrion, on June 2, 2011, certain assets, including (i) Talecris’ Melville, New York manufacturing facility, which we refer to as the Melville facility, (ii) United States marketing rights to Koate® antihemophilic factor, (iii) an agreed quantity of plasma and (iv) two plasma collection centers located in Mobile, Alabama and Winston Salem, North Carolina. Further, pursuant to the Consent Order, we and Kedrion entered into a contract manufacturing agreement under which we are supplying to Kedrion, for a period of seven years ending in 2018, Koate® and private label IVIG and albumin, for sale by Kedrion in the United States, and Kedrion exercised an option in 2014 to purchase a non-exclusive license to Koate®-related intellectual property for use in the United States. In accordance with the Consent Order, we leased the Melville facility from Kedrion until July 1, 2013, when we turned over operations at the facility to Kedrion.

Effective July 1, 2013 Grifols and Kedrion agreed to an early termination of the lease agreement and completed the transfer of operations at the Melville facility to Kedrion. The parties further entered into a three year fractionation agreement whereby Kedrion would continue to fractionate limited amounts of plasma for further manufacture by Grifols.

The Consent Order provides for a monitor to oversee our compliance with the Consent Order and requires us to submit to the FTC annual compliance reports for ten years. We filed our first compliance report, pursuant to paragraph IX.B of the Consent Order, on July 20, 2012. Grifols filed its seventh compliance report in July 2018. There has been no further action by the FTC. Our next compliance report is due in July 2019.

Antitrust Approval of Biotest Pharmaceuticals Corporation Acquisition

In August 2018, the FTC issued a consent order which allowed the acquisition of 24 donor centers and required the divestiture of three centers to Kedrion. The consent order requires annual reports to be made to the FTC for a period of 10 years. The first annual compliance report is due in March 2020.

Dividend Policy

Class A Shares

Our dividend policy is to pay out approximately 40% of our net consolidated profits. However, the New Credit Facilities contain limitations on our ability to pay cash dividends depending on our debt levels. We may only pay cash dividends if our Leverage Ratio (as defined in the New Credit Facilities) is less than 3.50:1.00. As of the date of this Annual Report on Form 20-F, this restriction does not currently apply. For a further discussion of the terms of the New Credit Facilities, see Item 5 of this Part I, “Operating and Financial Review and Prospects — B. Liquidity and Capital Resources — Sources of Credit—New Credit Facilities.”

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The declaration and payment of dividends is reviewed annually by the Board based upon a review of our balance sheet and cash flow, the ratio of current assets to current liabilities, our expected capital and liquidity requirements, the provisions of our governing documents and the provisions in our financing arrangements governing cash dividends. The payment of future dividend will be determined by the Board, based upon the factors described above and other factors that it deems relevant at the time that declaration of a dividend is considered. There can be no assurance as to whether or in what amounts any future dividend might be paid.

In addition, the availability of the reserves for distribution is subject to limitations under Spanish law. The distributable reserves of us and our Spanish subsidiaries are limited by the amount of mandatory reserves, which include, for us and each of our Spanish subsidiaries, the legal reserves and the amount of capitalized research and developments pending to be amortized by us and each of our Spanish subsidiaries. This limitation on distributable reserves due to capitalized research and developments expenditure amounted, on a consolidated basis, to €35.6 million at December 31, 2018.

At the general shareholders’ meeting held on May 25, 2018, our shareholders approved a dividend of €0.204 for each Class A share, for an aggregate dividend of €86.9 million, which was paid to the Class A shareholders on June 5, 2018. Additionally, on October 26, 2018, our Board approved an interim dividend of €0.20 for each Class A share, for an aggregate interim dividend of €85.2 million, which was paid to the Class A shareholders on December 4, 2018.

The Board intends to propose to shareholders at the upcoming annual general meeting of shareholders that profits for the year ended December 31, 2018, in the amount of €91 million be transferred to reserves.

Class B Shares

Each Class B share entitles its holder to receive a minimum annual preferred dividend out of the distributable profits at the end of each fiscal year the share is outstanding equal to €0.01 per Class B share, if the aggregate preferred dividend does not exceed the distributable profits for that year and provided that the distribution of dividends has been approved by our shareholders. In any given fiscal year, we will pay a preferred dividend to the holders of the Class B shares before any dividend out of the distributable profits for such fiscal year is paid to the holders of Class A shares. The preferred dividend on all issued Class B shares will be paid by us within the nine months following the end of that fiscal year, in an amount not to exceed the distributable profits obtained during that fiscal year.

At the general shareholders’ meeting held on May 25, 2018, our shareholders approved a dividend of €0.204 for each Class B share, for an aggregate dividend of €52.6 million, and a preferred dividend of €0.01 for each Class B share, for an aggregate preferred dividend of €2.6 million, which were paid to the Class B shareholders on June 5, 2018. Additionally, on October 26, 2018, our Board approved an interim dividend of €0.20 for each Class B share, for an aggregate interim dividend of €51.5 million, which was paid to the Class B shareholders on December 4, 2018. It is worth noting that the treasury Class B shares did not receive either dividend mentioned above.

B. Significant Changes

See Item 5 of this Part I, “Operating and Financial Review and Prospects — A. Operating Results — Subsequent Events.”

Item 9. THE OFFER AND LISTING

A. Offer and Listing Details

Our Class A shares have been listed on the Spanish Stock Exchanges since we completed our initial public offering on May 17, 2006 and are quoted on the Spanish Automated Quotation System under the ticker symbol “GRF.”

Our Class B shares have been listed on the Spanish Stock Exchanges since June 2, 2011 and quoted on the Spanish Automated Quotation System under the ticker symbol “GRF.P.”

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Our Class A ADSs are not listed on a national exchange and have traded on the Over the Counter Bulletin Board, an electronic stock listing service provided by NASDAQ, since July 2009.

Our Class B ADSs have been listed and traded on the NASDAQ Global Select Market under the symbol “GRFS” since June 2, 2011. Since July 23, 2012, each Class B ADS has represented one Class B share. Prior to July 23, 2012, each Class B ADS represented one-half of one Class B share. We effected the adjustment to the ADS to share ratio through an amendment to the depositary agreement.

B. Plan of Distribution

Not Applicable

C. Markets

Our Class A shares have been listed on the Spanish Stock Exchanges since May 17, 2006 and are quoted on the Spanish Automated Quotation System under the ticker symbol “GRF.” Our Class B shares were issued as part of the consideration for the Talecris acquisition and were listed on the Spanish Stock Exchanges on June 2, 2011 and quoted on the Spanish Automated Quotation System under the ticker symbol “GRF.P.”

Our Class B ADSs have been listed and traded on the NSADAQ Global Select Market under the symbol “GFRS” since June 2, 2011.

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Spanish Securities Market

The Spanish Stock Exchanges consist of four stock exchanges located in Madrid, Barcelona, Bilbao and Valencia. The majority of the transactions conducted on them are done through the Spanish Automated Quotation System. During 2018, the Spanish Automated Quotation System accounted for the majority of the total trading volume of equity securities on the Spanish Stock Exchanges.

Spanish Automated Quotation System

The Spanish Automated Quotation System was introduced in 1989 and links the Spanish Stock Exchanges, providing those securities listed on it with a uniform continuous market that eliminates most of the differences among the Spanish Stock Exchanges. The principal feature of the system is the computerized matching of buy and sell orders at the time of entry of the order. Each order is executed as soon as a matching order is entered, but can be modified or canceled until executed. The activity of the market can be continuously monitored by investors and brokers. The Spanish Automated Quotation System is operated and regulated by the Sociedad de Bolsas, a corporation owned by the companies that manage the Spanish Stock Exchanges. All trades on the Spanish Automated Quotation System must be placed through a bank, brokerage firm, an official stock broker or a dealer firm member of a local exchange directly.

There is a pre-opening session held from 8:30 a.m. to 9:00 a.m. local time each trading day, during which orders are placed. The computerized trading hours are from 9:00 a.m. to 5:30 p.m. Each session ends with a five-minute auction, between 5:30 and 5:35 p.m., with a random closedown of 30 seconds. The price resulting from each auction is the closing price of the session.

On May 14, 2001, new rules came into effect regarding the maximum price fluctuations in the price of stocks. Under the new rules, each stock in the continuous market is assigned a static and a dynamic range within which the price can fluctuate. The price of a stock may rise or fall by its static range (which is published once a month and is calculated according to the stock’s average historic price volatility) above or below its opening price (which is the closing price of the previous session). When the stock trades outside of this range, the trading of the stock is suspended for five minutes, during which an auction takes place. After this auction, the price of the stock can once again rise or fall by its static range above or below its last auction price (which will be considered as the new static price before triggering another auction). Furthermore, the price of a stock cannot rise or fall by more than its dynamic price range (which is fixed and published once a month and is calculated according to the stock’s average intra-day volatility), from the last price at which it has traded. If the price variation exceeds the stock’s dynamic range, a five-minute auction is triggered.

Moreover, there is a block market (el mercado de bloques) allowing for block trades between buyers and sellers from 9:00 a.m. to 5:30 p.m. during the trading session. Under certain conditions, this market allows cross-transactions of trades at prices different from prevailing market prices. Trading in the block market is subject to certain limits with regard to price deviations and volumes.

Between 5:30 p.m. and 8:00 p.m., trades may occur outside the computerized matching system without prior authorization of the Sociedad de Bolsas, at a price within the range of 5% above the higher of the average price and closing price for the day and 5% below the lower of the average price and closing price for the day, if there are no outstanding bids or offers, as the case may be, on the system matching or bettering the terms of the proposed off-system transaction, and if the trade involves more than €300,000 and more than 20% of the average daily trading volume of the stock during the preceding quarter. At any time before 8:00 p.m., a trade may take place (with the prior authorization of the Sociedad de Bolsas) at any price if:

· the trade involves more than €1.5 million and more than 40% of average daily trading volume of the stock during the preceding quarter;

· the trade relates to a merger or spin-off of a listed company;

· the trade relates to the reorganization of a business group;

· the trade is executed for the purposes of settling litigation;

· the trade involves certain types of contracts or complex transactions; or

· the Sociedad de Bolsas finds other justifiable cause.

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Information with respect to computerized trades between 9:00 a.m. and 5:30 p.m. is made public immediately, and information with respect to trades outside the computerized matching system is reported to the Sociedad de Bolsas and published in the Stock Exchange Daily Bulletin (Boletín Diario de Cotización) and in the Spanish Automated Quotation System by the next trading day.

Clearance and Settlement System

Until April 1, 2003, transactions carried out on the Spanish Stock Exchanges and the continuous market were cleared and settled through the Servicio de Compensación y Liquidación de Valores, S.A. Since April 1, 2003, the settlement and clearance of all trades on the Spanish Stock Exchanges, the Public Debt Market (Mercado de Deuda Pública), the AIAF Fixed Income Market (Mercado AIAF de Renta Fija) and the Market for Latin-American Stocks in Euros (Mercado de Valores Latinoamericanos en Euros) have been made through Iberclear, which was formed as a result of a merger between the Servicio de Compensación y Liquidación de Valores, S.A and Central de Anotaciones del Mercado de Deuda Pública, which was managed by the Bank of Spain.

Book-entry System

Ownership of shares listed on any Spanish Stock Exchange is required to be represented by entries in a register maintained by Iberclear, and transfers or changes in ownership are effected by entries in such register. The securities register system is structured in two levels: the central registry managed by Iberclear, which keeps the securities balances of the participants, and a detailed registry managed by the participants where securities are listed by holder’s name.

Securities Market Legislation

The Spanish Securities Market Act (today known as Real Decreto Legislativo 4/2015, de 23 de octubre, que aprueba el texto refundido de la Ley del Mercado de Valores), or Securities Market Act, which first came into effect in 1989, among other things:

· established an independent regulatory authority, the CNMV, to supervise the securities markets;

· established a framework for the regulation of trading practices, tender offers and insider trading;

· required stock exchange members to be corporate entities;

· required companies listed on a Spanish Stock Exchange to file annual audited financial statements and to make public quarterly financial information;

· established a framework for integrating quotations on the Spanish Stock Exchanges by computer;

· exempted the sale of securities from transfer and value added taxes;

· deregulated brokerage commissions as of 1992; and

· provided for transfer of shares by book-entry or by delivery of evidence of title.

The Securities Market Act was amended by, among others, Law 37/1998, which implemented two European Union directives that innovated the Securities Market Act. The first was the recognition that both Spanish and other European Union member state companies authorized to provide investment services have full access to the official secondary securities markets, with full capacity to operate, thereby enabling the direct admission of banking entities into the stock exchange area. The second innovation was that the scope of the Securities Market Act was enlarged to include a list of financial instruments, such as financial exchange contracts, or installment financial contracts, which expanded the categories of securities included.

The Securities Market Act was further amended by Law 44/2002 (November 22, 2002) on reform measures of the financial system, which introduced certain modifications to the laws governing financial markets and corporations generally, including:

· provisions requiring listed companies to establish an audit committee, redefining the reporting requirements for relevant events, establishing rules relating to the treatment of confidential and insider information and related party transactions, preventing manipulative and fraudulent practices with respect to market prices and otherwise regarding market transparency;

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· the establishment of Iberclear; and

· the authorization of the Ministry of Economy and Finance (Ministerio de Economía y Hacienda) to regulate financial services electronic contracts.

On July 17, 2003, the Securities Market Act was amended by Law 26/2003 in order to reinforce the transparency of listed companies. It introduced:

· information and transparency obligations including detailed requirements of the contents of the corporate website of listed companies and the obligation to file with the CNMV an annual corporate governance report; and

· the obligation to implement a series of corporate governance rules including, among others, regulations regarding the boards of directors and the general shareholders’ meeting.

On March 11, 2005, Royal Decree Law 5/2005 was approved, modifying the Securities Market Act in order to implement Directive 2003/71/EC of the European Parliament and of the Council of the European Union, or Council, on the prospectus to be published when securities are offered to the public or admitted to trading. The Directive (i) harmonizes the requirements for the process of approval of prospectuses, which enables a prospectus to be valid throughout the European Union and (ii) incorporates the application of the country-of-origin principle later set forth in Spanish Royal Decree, or Royal Decree, 1362/2007.

Law 12/2006, of May 16, 2006, amended the Securities Market Act by (i) introducing a new article relating to notifications to the CNMV of transactions that might constitute insider dealing or market manipulation, (ii) completing the regulation of Bolsas y Mercados Españoles, which operates the Spanish Stock Exchanges and financial markets and (iii) clarifying the regulation of significant participations in the entities that manage the clearing and settlement of securities and the Spanish secondary securities markets.

Law 6/2007, of April 12, 2007, amended the Securities Market Act to modify the rules for takeover bids and for issuer transparency. This Law came into effect on August 13, 2007, and partially integrates into the Spanish legal system Directive 2004/25/EC of the European Parliament and of the Council, of April 21, 2004, on takeover bids and Directive 2004/109/EC of the European Parliament and of the Council, of December 15, 2004, on the harmonization of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC. This Law was further developed by Royal Decree 1066/2007, of July 27, 2007, on rules applicable to takeover bids for securities; by Royal Decree 1362/2007, of October 19, 2007, on transparency requirements for issuers of listed securities; and by Royal Decree 1698/2012, of December 21, 2012, to implement Directive 2010/73/EC of the European Parliament and of the Council, of December 24, 2010 (amending Directive 2003/71/CE and Directive 2004/109/EC).

Law 6/2007 (i) introduced several changes to the periodic financial information (annual, biannual and quarterly) to be published by issuers of listed securities and (ii) introduced new developments to the system that establishes the duty to provide notice of significant stakes in an enterprise. These duties include notification requirements such as:

· anyone with a right to acquire, transfer or exercise voting rights granted by the shares, regardless of the actual ownership of the shares, and anyone owning, acquiring or transferring other securities or financial instruments that grant a right to acquire shares with voting rights must provide notice of the holding of a significant stake in accordance with the regulations;

· directors of listed companies, in addition to providing notice of any transaction concerning the shares or other securities or financial instruments of the issuer that are linked to these shares, must inform the CNMV of their stake upon appointment or resignation; and

· listed companies must provide notice of transactions concerning their treasury shares in certain cases, which will be established in the developing regulations.

Law 12/2010, of June 30, 2010, amended the Securities Market Act to require listed companies to create electronic shareholders forums on their websites to facilitate communication prior to the holding of general meetings. It also established that shareholders of listed companies may create associations to exercise their rights and coordinate the defense of their common interests. Such associations must enroll in a special CNMV registry. Finally, Law 12/2010 also amended the Securities Market Act to change the regulations regarding the composition and functions of audit committees.

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Royal Legislative Decree 1/2010, of July 2, 2010, approved the Spanish Companies Act in order to consolidate and clarify the laws applicable to public limited companies, limited share partnerships and limited liability companies.

Law 2/2011, of March 4, 2011, on Sustainable Economy (Ley de Economía Sostenible) amended the Securities Market Act’s provisions related to the requirements for annual reports on corporate governance and management reports. The Law also made certain corporate governance and shareholder disclosure recommendations in the Spanish Unified Good Governance Code for Listed Companies (Código Unificado de Buen Gobierno de las Sociedades Cotizadas), or CNMV Governance Code, regarding the composition of boards of directors and its committees and the qualification of directors as executive, proprietary or independent mandatory. The current Spanish Good Governance Code for Listed Companies was approved on 2015. It unified the recommendations and principles that are applicable to Spanish listed companies; removed some principles and recommendations of the Unified Good Governance Code for Listed Companies that were written into Spanish legislation and introduced some recommendations on the corporate social responsibility of listed companies.

Law 25/2011, of August 1, 2011, amended the Securities Market Act to implement Directive 2007/36/CE of the European Parliament and of the Council, regarding the exercise of certain rights of the shareholders of listed companies, to simplify and promote the right to information and shareholder voting rights.

Law 1/2012, of June 22, 2012, amended the Spanish Companies Act by making corporate websites mandatory for listed companies and introducing other new requirements regarding the creation, amendment, transfer and removal of corporate websites, as well as the obligations of directors arising in connection with the contents of such websites.

Law 31/2014 amended the Spanish Companies Act to improve the corporate governance practices, increase management efficiency and increase the transparency of companies listed on a Spanish Stock Exchange.

Royal Legislative Decree 4/2015, of October 23, 2015, approved the revised Securities Market Act and, thus, abolished the former Securities Market Act from 1988. Certain adjustments have been made to the structure of the former Securities Market Act to improve its organization and eliminate a number of inconsistencies. Additionally, the new text has also been prepared to transpose Regulation (EU) No 596/2014 of the European Parliament and of the Council of April 16, 2014, on market abuse and, also, the MIFID2 rules (Directive 2014/65/EU of the European Parliament and of the Council of May 15, 2014, on markets in financial instruments and Regulation (EU) No 600/2014 of the European Parliament and of the Council of May 15, 2014).

Royal Decree 878/2015, on the clearing, settlement and recording of transferable securities represented in book-entry form, on the legal regime of the central securities depositaries and central counterparties, and on the transparency requirements for issuers of securities admitted to trading in a regulated, which was published in the Spanish Official Gazette on October 3, 2015, meets the need to develop the latest amendments introduced in the Securities Market Act in matters of book-entries and clearing and settlement of securities, in addition to the need to adapt our legal system to a number of EU Law provisions. The reform of our post-trading system seeks to improve its efficiency and stability, in addition to equating the securities clearing, settlement and recording activities to those of the European markets, thus helping to reduce operational costs and improve the competitiveness of our markets, entities and infrastructures and, consequently, of the financial sector. On April 27, 2016, the new post trading system of clearing and settlement of shares kicked off.

Regulation (EU) No. 596/2014, on market abuse, which was directly applicable in all European Union member states, came into force in 2016 with the aim to ensure that European Union regulation keeps pace with market developments in order to combat market abuse on financial markets as well as across commodity and related derivative markets.

Royal Legislative Decree 14/2018, of September 28, 2018, amended the Securities Market Act to integrate into the Spanish legal system Directive 2014/65/EU of the European Parliament and of the Council of May 15, 2014, on markets in financial instruments. It is aimed at improving the soundness, transparency and regulation of the Spanish Financial Market´s trading activities, increasing the investor protection and harmonizing the regulations of the Spanish Financial Markets market regulations with the rest of the countries in the Union. The directive has been further integrated into the Spanish legal system by Royal Decree 1464/2018, of December 21, 2018.

Royal Legislative Decree 19/2018, of November 23, 2018, on payment services and other urgent financial measures amends among others, the Securities Market Act in order to integrate into the Spanish legal system, and Regulation (EU) No. 596/2014, on market abuse. The main novelties introduced to the Securities Market Act are (i) the distinction between the concepts of inside information and relevant information, (ii) the removal of the obligation to have an internal code of conduct for securities markets and (iii) the reduction of the notification threshold of people with management responsibilities.

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On December 28, 2018, the Spanish Commercial Code, the Companies Act and the Audit Act were amended by Law 11/2018 in order to reinforce the disclosure of non-financial and diversity information, among others, of listed companies. It introduced information and diversity obligations including (i) the obligation to prepare a non-financial information statement on environmental matters, social and employee-related matters, respect for human rights, anti-corruption and bribery matters and society matters and (ii) the obligation to ensure that the selection procedures for Company directors facilitate diversity in relation to age, disability and training as well as gender, experience and knowledge.

D. Selling Shareholders

Not Applicable.

E. Dilution

Not Applicable.

F. Expense of the Issue

Not Applicable.

Item 10. ADDITIONAL INFORMATION

A. Share Capital

Not Applicable.

B. Memorandum and Articles of Association

The following is a summary of the material terms of our Articles of Association and Board Regulations, as amended and currently in effect. This summary is not meant to be complete and is qualified in its entirety by reference to each of the Articles of Association and Board Regulations. Because this is a summary, it does not contain all the information that may be important to you. You should read the Articles of Association and Board Regulations carefully. The current Articles of Association are included as Exhibit 1.1 and Exhibit 1.2 (English translation) to this annual report on Form 20-F. The Articles of Association and the Board Regulations are also available on our website, which does not form part of this annual report on Form 20-F, at www.grifols.com under the headings “Investors — Corporate Governance — Articles of Association” and “Investors — Corporate Governance — Board of Directors, Regulations.”

The Articles of Association were originally approved and incorporated with the Commercial Registry on June 22, 1987. The Board Regulations were initially approved by the Board on April 5, 2006.

At the general shareholders’ meeting held on May 29, 2015, the shareholders voted to amend our Articles of Association on matters pertaining to corporate governance in order to ensure compliance with the amended Spanish Companies Act. The shareholders renewed the delegation of authority to the Board to effect a two-to-one split of the Class A and Class B shares, within one year following the date of the meeting, by reducing the nominal value and increasing the number of such shares, without changing the total nominal value of the share capital. Finally, the shareholders provided the Board authorization for the derivative acquisition of treasury stock thereby revoking and leaving without effect the authorization granted to the Board during the shareholder meeting on extraordinary matters held on January 25, 2011.

At the general shareholders’ meeting held on May 27, 2016, the shareholders voted to delegate to the Board, with full power of substitution in any of its members, the authority to increase the Company’s share capital at once or in several times and at any given moment, within a maximum term of five (5) years as from the date of the May 27, 2016, general meeting, and in an amount that in no case may exceed half of the Company’s share capital at the time of this authorization. Pursuant to this authorization, the share capital increases will be carried out, if appropriate, by issuing and placing in circulation the new shares (whether of Class A and Class B, exclusively Class A or exclusively Class B), with or without share premium, with a consideration consisting in cash contributions. As long as there are non-voting Class B shares in circulation, the capital increases will observe, when applicable, the provisions of the Company’s Articles of Association as regards the pre-emptive right of acquisition that may correspond in said capital increases. Likewise, as long as Class B shares hold the redemption rights foreseen in paragraph 4 of article 6.bis of the Articles of Association,

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the nominal value of the Class B shares that may be issued in the execution of this delegation of authorities cannot exceed one fourth of the total amount of the share capital resulting from the capital increase resolution.

At the general shareholders’ meeting held on May 26, 2017, the shareholders voted to amend our Articles of Association concerning the composition and functions of the Audit Committee, in order to conform its content to the latest amendments of the Companies Act introduced by the Audit Act currently in force. The shareholders also voted to amend the regulation of the general shareholders’ meeting, concerning the competences of the general shareholders’ meeting, in order to adapt its content to the latest amendments of the Companies Act, introduced by Law 5/2015 of promotion of business financing (Ley 5/2005 de fomento de la financiación empresarial), on matters of issuance of bonds and other securities. The amendment consists of eliminating the issuance of numbered series of bonds or other securities, whether convertible or not, that may recognize or create a debt expressly as a competence of the general shareholders’ meeting. The shareholders also renewed the delegation of authority to apply for the listing of the Class A shares on NASDAQ, via Class A ADSs, within three years following the date of the meeting.

The Board, with full power of substitution in any of its members, has the authority to set the terms and conditions of the capital increases and the characteristics of the shares in all aspects not foreseen by the general shareholders’ meeting, as well as to freely offer the new unsubscribed shares within the term(s) of exercise of the pre-emptive right of subscription; establish that, in the event of an incomplete subscription, the share capital will be increased only in the amount of the subscriptions effectively carried out; redraft the articles of the Articles of Association related to share capital and number of shares; exclude, pursuant to the provisions of article 506 of the Companies Act, the pre-emptive right in the terms and conditions set forth therein and up to a maximum of 20% of the Company’s share capital; apply for, when appropriate, the listing of the shares issued pursuant to this authorization, as well as to carry out all the necessary actions and procedures and to file the documents that might be required before the competent bodies of the above-mentioned stock exchange markets, for admission to listing of the new shares issued as a consequence of the agreed capital increase; it is expressly put on record that Grifols agrees to be bound by already existing and future rules related to the Stock Exchange matters and, specially, as regards contracting, permanence and exclusion from official listing; request the inclusion of the new shares in the accounting registries of the company Sociedad de Gestión de los Sistemas de Registro, Compensación y Liquidación de Valores, S.A.U. (Iberclear).

The full text of the amendments to the Articles of Association detailed above is available on our website, which does not form part of this annual report on Form 20-F, at www.grifols.com under the heading “Investors— Corporate Governance.”

General

As of December 31, 2018, our share capital was €119,603,705 and comprised:

· Class A shares: 426,129,798 ordinary shares with a par value of €0.25 each. All of the Class A shares belong to the same class and series.

· Class B shares: 261,425,110 non-voting preference shares with a par value of €0.05 each. All of the Class B shares belong to the same class and series and have the preferential rights set forth in the Articles of Association.

All of our shares are fully paid and non-assessable. Both share classes are issued in book-entry form, governed by the Securities Market Act, as amended, and such other provisions as may be applicable. The book-entry registry is maintained by Iberclear and its participant entities.

In exercise of the authorities granted to the Board of Directors by the Company’s general shareholders’ meeting held on May 29, 2015, on December 3, 2015, our Board agreed to carry out a two-to-one split of all of our existing Class A and Class B shares. Said split was carried out on January 4, 2016. The Board effected a two-to-one split of the Class A and Class B shares by reducing the nominal value and increasing the number of such shares, without changing the total nominal value of the share capital in accordance with the shareholder resolution passed at the general shareholders’ meeting held May 29, 2015.

Register

We are a public limited trading company registered with the Commercial Registry of Barcelona. Our fiscal identification number is A-58389123.

Our principal executive office is located at Avinguda de la Generalitat, 152 Parque Empresarial Can Sant Joan, 08174 Sant Cugat del Vallès, Barcelona, Spain. Our registered office is located at c/Jesús y María, 6, Barcelona (08022). We were incorporated on June 22, 1987. Our fiscal year runs from January 1 to December 31.

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Corporate Purpose

Article 2 of the Articles of Association states that our corporate purpose is to provide administration, management and supervision services of companies and businesses as well as investments in personal and real estate assets.

Board of Directors

Under Article 31 of the Board Regulations, a director shall abstain from attending or intervening in deliberations that affect matters in which he (or any person related to him) is personally involved, directly or indirectly. A director cannot carry out professional or commercial transactions with us, directly or indirectly, unless he previously informs the Board about the conflict of interest, and the Board, following a report from our Appointments and Remuneration Committee, approves the transaction.

Under Article 15 of the Board Regulations, the Appointments and Remuneration Committee will in all cases be fully composed of non-executive directors, two of which shall be independent directors, and the chairperson must be an independent director.

The Board, with the advice of the Appointments and Remuneration Committee, sets director compensation. As set forth in Article 20.bis of our Articles of Association the directors’ remuneration shall be a fixed amount. Furthermore, as set forth in Article 26 of the Board Regulations, every three years the general shareholders’ meeting must approve the remuneration policy for the directors which shall remain in force for the three fiscal years following the year of its approval and must be in line, where applicable, to the remuneration system laid down in the Articles of Association. As set forth in Article 27 of such Board Regulations, non-executive directors should be excluded from receiving remuneration linked to our profits or welfare systems, other than shares in Grifols, S.A., that they must hold until their resignation as directors. Further, the establishment of equity compensation plans in which members of the Board participate must be authorized in the Articles of Association and requires the shareholders’ prior approval at a shareholders’ meeting. Additionally, the amount of non-executive directors’ remuneration should be calculated in order to incentivize dedication but not become an obstacle to independence.

For more information regarding related party transactions, see Item 7 of this Part I, “Major Shareholders and Related Party Transactions — B. Related Party Transactions.”

We do not impose an age limit requirement for the retirement or non-retirement of directors. We also do not impose a shareholding requirement for director qualification. Article 6 of the Board Regulations does provide, however, that a director cannot qualify as an independent external director if he or she has a significant shareholding in us.

For information regarding the provisions of the Articles of Association as applied to the Board, see Item 6 of this Part I, “Directors, Senior Management and Employees — A. Directors and Senior Management — Directors” and “Directors, Senior Management and Employees — C. Board Practices.”

The following summary of material considerations concerning our share capital briefly describes certain material provisions of the Articles of Association and Spanish law relating to our share capital. Because it is a summary, it is not meant to be complete, is qualified by reference to the applicable Spanish laws and our Articles of Association and does not contain all the information that may be important to you.

Neither Spanish law nor our Articles of Association limit the right to own our securities, including the rights of non-resident or foreign shareholders to hold or exercise voting rights on the securities.

Under Spanish law, the rights of shareholders may be changed only by an amendment to the articles of association of a company that complies with the requirements explained below under “— Class A Shares — Shareholders’ Meetings and Voting Rights.” Our Articles of Association do not further specify what actions or quorums are required to change the rights of our shareholders, other than that they classify an amendment thereto as an extraordinary matter, as described below in “— Class B Shares — Separate Vote at General Shareholder Meetings on Extraordinary Matters.”

Class A Shares

Shareholders’ Meetings and Voting Rights

Pursuant to Article 13 of our Articles of Association and the Spanish Companies Act, the annual general shareholders’ ordinary meeting shall be held during the first six months of each fiscal year on a date fixed by the Board. Resolutions presented at

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duly constituted general shareholders’ meetings are, except as indicated herein, passed by a simple majority vote of the voting capital present or represented at the meeting.

Extraordinary meetings may be called by the Board whenever it deems it appropriate or at the request of one or more shareholders representing at least 3% of our share capital. The requesting shareholders must state in their request the matters to be addressed at the meeting. Per Spanish Law and the Articles of Association, we are required to publish a “calling of the meeting,” which sets forth the matters to be voted on at each general shareholders’ meeting, at least one month prior to the date set for the meeting in at least: (i) the Official Gazette of the Commercial Registry (Boletin Oficial de Registro Mercantil) or one of the local newspapers of wide circulation in the province where we are domiciled (currently Barcelona, Spain); (ii) CNMV’s website; and (iii) our website.

Holders of ordinary and Class B shares duly registered in the book-entry records maintained by Iberclear and its participant entities at least five days prior to the day on which a shareholders’ meeting is scheduled, in the manner provided in the notice for such meeting, may attend such meeting (in person or represented by proxy) and, where so entitled, may vote. Holders of our Class B shares generally do not have voting rights, except with respect to certain extraordinary matters that require approval by a majority of our outstanding Class B shares, as set forth below in “— Class B Shares — Separate Vote at General Shareholder Meetings on Extraordinary Matters.”

For an ordinary or extraordinary general meeting of shareholders to be duly constituted on the first call, the presence in person or by proxy of shareholders representing 25% of our issued voting share capital is required to constitue a quorum and proceed. If a quorum is not obtained on the first call, a meeting is validly convened on the second call regardless of the share capital in attendance.

Under Spanish law, the following shareholder actions require approval by the affirmative vote of the holders of a majority of our Class A shares present in person or represented by proxy at a duly constituted meeting of holders of our Class A shares at which meeting, if (i) on first call, a quorum of at least 50% of the issued voting share capital is present or represented by proxy or (ii) on second call, a quorum of at least 25% of the issued voting share capital is present or represented by proxy (unless on such second call less than 50% of the issued voting share capital is present or represented by proxy, in which case those matters require the affirmative vote of at least two-thirds of the share capital present or represented at such meeting):

· the issuance of bonds;

· an increase or reduction of the share capital, or the suppression/limitation of pre-emptive rights in issuances of new shares;

· the transformation of Grifols (change in corporate nature);

· a merger, de-merger, split, spin-off or other structural change subject to Law 3/2009;

· any other amendment of the Articles of Association; and

· a dissolution.

For purposes of determining the quorum, those shareholders who vote by mail or through the internet are counted as being present at the meeting, as provided by the regulations of the general shareholders’ meeting of Grifols, S.A (Reglamento de la Junta General de Accionistas). Such regulations are available on our website, which does not form part of this annual report on Form 20-F, at www.grifols.com under the heading “Investors — Corporate Governance — Shareholders’ General Meeting — Regulations of the General Shareholders’ Meeting.”

In general, resolutions passed at a general shareholders’ meeting are binding upon all shareholders. In very limited circumstances, Spanish law gives dissenting or absent shareholders, including those holding Class B shares, the right to have their Grifols’ shares redeemed by us at prices determined in accordance with established formulas or criteria.

Dividends

Payment of dividends must be proposed by the Board and authorized by our shareholders at a general shareholders’ meeting. Interim dividends may be declared by the Board on account of profits for the then current fiscal year, subject to certain limitations.

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Spanish law requires each company to apply at least 10% of its net income each year to a legal reserve until the balance of such reserve is equivalent to at least 20% of such company’s issued share capital. A company’s legal reserve is not available for distribution to its shareholders except upon such company’s liquidation. According to Spanish law, dividends may only be paid out of profits (after deduction of any amounts required to be applied to the legal reserve) or distributable reserves and only if the value of a company’s net worth is not, and as a result of distribution would not be, less than such company’s share capital.

In addition, no profits may be distributed unless the amount of the distributable reserves is at least equal to the amount of research and development expenses recorded as an asset on a company’s consolidated balance sheet.

Spanish law also requires the creation of a non-distributable reserve equal to the amount of goodwill recorded as an asset on a company’s consolidated balance sheet and that an amount at least equal to 5% of such goodwill be transferred from the profit from each financial year to such non-distributable reserve until such time as the non-distributable reserve is of an amount at least equal to the goodwill recorded on such company’s consolidated balance sheet. If, in any given financial year, there are no or insufficient profits to transfer an amount equal to 5% of the goodwill recorded as an asset on a company’s consolidated financial statement, Spanish law requires that the shortfall be transferred from freely distributable reserves to the non-distributable legal reserve.

In the event of a reduction in share capital to offset losses, dividends may not be distributed until the legal reserve reaches 10% of the new share capital.

Distributions of dividends to our Class A shareholders will be made in proportion to the capital that they have paid up. The shareholders at the general shareholders’ meeting shall decide the amount, time and form of payment of the dividends. If these details are not so determined, the dividend will be payable at our registered office on the day following the date of the resolution.

The right to a dividend lapses and reverts to us if it is not claimed within five years after it becomes payable. Dividends payable by us to non-residents of Spain may be subject to a Spanish withholding tax of 19%, effective January 1, 2016. However, residents of certain countries are entitled to the benefits of the Convention Between the United States of America and the Kingdom of Spain for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income, as described below in “— E. Taxation — Spanish Tax Considerations.”

As set forth below under “— Class B Shares — Preferred Dividend,” since the issuance of the our Class B shares, the dividend rights of our Class A shareholders have been subordinated to the €0.01 per share preferred dividend of our Class B shares.

Liquidation Rights

Upon our winding-up and liquidation, holders of our Class A shares and Class B shares will be entitled to receive a pro rata portion of any assets remaining after the payment of our debts, taxes and the expenses of the liquidation as follows: (i) before any amount is distributed to the holders of Class A shares, the holders of Class B shares will receive the nominal value and share premium paid up for such Class B shares at the time of issuance and (ii) once such liquidation preference is received, the holders of the Class A shares and Class B shares will share pari passu in the amounts distributed.

Subscription (or Preemptive) Rights and Increases of Share Capital

Pursuant to the Spanish Companies Act, shareholders and holders of convertible bonds have subscription (or preemptive) rights to subscribe for any new shares (or other securities convertible into, or exchangeable for, shares) issued by a company in a capital increase via monetary contributions.

In accordance with the Spanish Companies Act, such subscription (or preemptive) rights may be waived under special circumstances by a resolution passed at a meeting of shareholders or the Board (such as when we listed on the Spanish Stock Exchanges), and the general shareholders’ meeting delegates to the Board the right to increase the share capital or to issue securities convertible into, or exchangeable for, shares and to waive subscription (or preemptive) rights). See Item 3 of this Part I, “Key Information — D. Risk Factors — Risks Relating to our Structure, Shares and American Depositary Shares — Subscription (or preemptive) rights may be unavailable to U.S. holders of our shares or ADSs.”

Further, subscription (or preemptive) rights, in any event, will not be available in the event of certain capital increases, such as those in which we receive an in-kind contribution, those effected to meet the requirements of a convertible bond issue or those for a merger in which shares are issued as consideration. Subscription (or preemptive) rights are transferable, may be traded on the Spanish Automated Quotation System and may be of value to existing shareholders because new shares may be offered for subscription at prices lower than prevailing market prices. In the case of a share capital increase against reserves, the same rule applies to the free allotment (derecho de asignación gratuita) rights.

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Finally, as described below in “— Class B Shares — Subscription Rights,” in connection with an issuance of securities where subscription (or preemptive) rights apply, our Class B shares may only be granted preemptive rights with respect to additional Class B shares if our Class A shares are granted preemptive rights with respect to additional Class A shares. The preemptive rights of each class must be otherwise equal.

Registration and Transfers

Our Class A shares are in book-entry form on Iberclear and are indivisible. Joint holders of one share must designate a single person to exercise their shareholders’ rights, but they are jointly and severally liable to us for all the obligations flowing from their status as shareholders, such as the payment of any pending capital calls.

Iberclear maintains the central registry reflecting the number of shares held by each of its participant entities. Each participant entity, in turn, maintains a registry of the owners of such shares.

Transfers of shares quoted on the Spanish Stock Exchanges are normally made through credit entities or investment companies that are members of the Spanish Stock Exchanges.

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Reporting Requirements

Pursuant to Royal Decree 1362/2007, any individual or legal entity that, by whatever means, acquires or transfers shares with voting rights in a company for which Spain is listed as the Country of Origin (Estado Miembro) (as defined therein) and which is listed on an official secondary securities market or other regulated market in the European Union must notify the issuer and the CNMV, if, as a result of such transaction, the proportion of voting rights held by that individual or legal entity reaches, exceeds or thereafter falls below a 3% threshold of that company’s total voting rights. The notification obligations are also triggered at thresholds of 5% and multiples thereof (excluding 55%, 65%, 85%, 95% and 100%). The applicable threshold is 1% (or its successive multiples thereof) for persons or entities located in designated “tax havens” (as defined in Royal Decree 1080/1991) or other jurisdictions lacking adequate supervision.

The individual or legal entity obliged to provide the notification must serve the notification by means of the form approved by the CNMV from time to time for such purpose, within four business days from the date on which the transaction is acknowledged. Royal Decree 1362/2007 deems that a transaction is “acknowledged” within two business days from the date on which such transaction is entered into.

The reporting requirements apply not only to the purchase or transfer of voting shares, but also to those transactions in which, without a purchase or transfer, the proportion of voting rights of an individual or legal entity reaches, exceeds or thereafter falls below the threshold that triggers the obligation to report as a consequence of a change in the total number of voting rights of a company on the basis of the information reported to the CNMV and disclosed by such individual or legal entity.

Regardless of the actual ownership of the voting shares, any individual or legal entity with a right to acquire, transfer or exercise voting rights of the shares, and any individual or legal entity that owns, acquires or transfers, whether directly or indirectly, other securities or financial instruments that grant a right to acquire shares with voting rights, will also have an obligation to notify us and the CNMV of the holding of a significant stake in accordance with the regulations.

Furthermore, all members of the Board must report to both us and the CNMV the percentage and number of voting rights in Grifols held by them at the time of becoming or ceasing to be a member of the Board. All members of the Board must also report any change in the percentage of voting rights they hold, regardless of the amount, as a result of any acquisition or disposition of our shares or voting rights, or financial instruments that carry a right to acquire or dispose of shares that have voting rights attached, including any stock-based compensation that they may receive pursuant to any of our compensation plans.

In addition, pursuant to the Securities Market Act, any member of the Board and any parties closely related to any member of the Board must similarly report any acquisition or disposal of our shares (in this case, either Class A or Class B shares), derivatives or other financial instruments relating to our shares regardless of the size, including information on the percentage of voting rights which they hold as a result of the relevant transaction within five business days of such transaction. In this respect, Regulation (EU) No. 596/2014, on market abuse, introduces certain changes as regards notifications from directors. From a practical viewpoint, the transactions that may be notified are broadened, the notification period is reduced from 5 to 3 business days and the prohibition against directors and executives to trade during 30 calendar days before the publication of an interim or annual financial report (restricted periods or “blackouts”) is regulated. Royal Legislative Decree 19/2018, which amends the Securities Market Act and implements Regulation (EU) No. 594/2014, on market abuse, establishes that persons discharging managerial responsibilities, as well as persons closely associated with them, must report to Grifols and the CNMV any acquisition or disposal of our shares (in this case, either Class A or Class B shares), derivatives or other financial instruments relating to our shares, once the sum of the amounts of all transactions made within a calendar year reaches the amount of €20,000.

Additional disclosure obligations apply in respect of voting agreements. In this respect, the Spanish Companies Act requires parties to disclose certain types of shareholders’ agreements that affect the exercise of voting rights at a general shareholders’ meeting or contain restrictions or conditions on the transferability of shares or bonds that are convertible or exchangeable into shares.

Moreover, persons holding a net aggregate short position in our shares must report the short position to the CNMV on a confidential basis whenever it reaches 0.2% and notify the CNMV of any subsequent decrease or increase by 0.1% (and successive multiples thereof) within the day immediately following the relevant trade. The CNMV publishes individual net short positions of 0.5% or more and aggregate information on net short positions between 0.2% and 0.5%.

The Articles of Association do not contain additional provisions governing the ownership threshold above which shareholder ownership must be disclosed.

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Class B Shares

Our Class B shares have substantially similar dividend and other economic rights as our Class A shares, summarized above in “— Class A Shares,” but differ from the Class A shares in some important respects that are outlined below.

Voting Rights

Holders of our Class B shares generally do not have voting rights, except with respect to certain extraordinary matters, with respect to which approval by a majority of our outstanding Class B shares is required.

Separate Vote at General Shareholder Meetings on Extraordinary Matters

Notwithstanding the lack of voting rights of our Class B shares generally, resolutions on the matters detailed below (each, an “extraordinary matter”) require the approval of a majority of our outstanding Class B shares.

· Any resolution (i) authorizing us or any of our subsidiaries to repurchase or acquire any of our Class A shares, except for pro rata repurchases available equally to holders of our Class B shares on the same terms and at the same price as offered to holders of our Class A shares or (ii) approving the redemption of any of our shares and any share capital reductions (through repurchases, cancellation of shares or otherwise), other than (a) those redemptions required by law and (b) those redemptions which affect equally our Class A shares and Class B shares and in which each Class B share is treated the same as a Class A share in such transaction.

· Any resolution approving the issuance, granting or sale (or authorizing the Board to issue, grant or sell) (i) any of our shares, (ii) any rights or other securities exercisable for or exchangeable or convertible into our shares or (iii) any options, warrants or other instruments giving the right to the holder thereof to purchase, convert, subscribe or otherwise receive any of our securities, except if (a) each Class B share is treated the same as a Class A share in the relevant issuance, grant or sale and, therefore, has a preferential subscription right (derecho de suscripción preferente) or a free allotment right in the relevant issuance, grant or sale to the same extent, if any, as a Class A share or (b) if the issuance is made in accordance with the subscription rights described in “— Subscription Rights” below.

· Any resolution approving unconditionally or not (i) a transaction subject to Law 3/2009 (including, without limitation, a merger, split-off, cross-border redomiciliation or global assignment of assets and liabilities), except if in such transaction each Class B share is treated the same as a Class A share or (ii) our dissolution or winding-up, except where such resolution is required by law.

· Any resolution for the delisting of any Grifols shares from any stock exchange.

· Generally, any resolution and any amendment of the Articles of Association that directly or indirectly adversely affects the rights, preferences or privileges of our Class B shares (including any resolution that adversely affects our Class B shares relative to our Class A shares or that positively affects our Class A shares relative to our Class B shares, or that affects the provisions in the Articles of Association relating to our Class B shares).

The general shareholders’ meeting has the power to decide on all matters assigned to it by law or by the Articles of Association and, in particular, without limitation to the foregoing, shall be the only corporate body or office entitled to decide on these extraordinary matters.

Preferred Dividend

Each of our Class B shares entitles its holder to receive a minimum annual preferred dividend out of the distributable profits at the end of each fiscal year the share is outstanding equal to €0.01 per Class B share. In any given fiscal year, we will pay a preferred dividend to the holders of our Class B shares before any dividend out of the distributable profits for such fiscal year is paid to the holders of our Class A shares. The preferred dividend on all issued Class B shares will be paid by us within the nine months following the end of that fiscal year, in an amount not to exceed the distributable profits obtained by us during that fiscal year.

If, during a fiscal year, we have not obtained sufficient distributable profits to pay in full, out of those profits, the preferred dividend on all the Class B shares outstanding, the preferred dividend amount exceeding the distributable profits obtained by us will not be paid and will not be accumulated as a dividend payable in the future.

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Lack of payment, total or partial, of the preferred dividend during a fiscal year due to insufficient distributable profits to pay in full the preferred dividend for that fiscal year will not cause our Class B shares to recover any voting rights.

As set forth above in “— Class A Shares — Dividends,” the dividend rights of our Class A shareholders are subordinated to the preferred dividend described in this section.

Other Dividends

Each Class B share is entitled to receive, in addition to the preferred dividend referred to above, the same dividends and other distributions (in each case, whether in cash, securities of Grifols or any of our subsidiaries, or any other securities, assets or rights) as one Class A share. Each Class B share is treated as one Class A share for the purpose of any dividends or other distributions made on our Class A shares, including as to the timing of the declaration and payment of any such dividend or distribution.

Redemption Rights

Each holder of our Class B shares is entitled to redeem those shares as set forth in this section if a tender offer for all or part of our share capital is made and settled (in whole or in part), except if holders of our Class B shares were entitled to (i) participate in such offer and (ii) have their shares acquired in such offer equally and on the same terms as holders of our Class A shares (including, without limitation, for the same consideration).

Upon the closing and settlement (in whole or in part) of a tender offer for our shares in which holders of our Class B shares were not entitled to (i) participate and (ii) have their shares acquired in such offer equally and on the same terms as holders of our Class A shares (including, without limitation, for the same consideration), the redemption process will follow the process detailed below.

· We will, within ten days of the date on which the redemption event occurred (i.e., the date on which the triggering tender offer settled), publish in the Commercial Registry Gazette, the Spanish Stock Exchanges’ Gazettes and in at least two of the newspapers with widest circulation in Barcelona an announcement informing the holders of our Class B shares of the redemption event and the process for the exercise of redemption rights in connection with such redemption event.

· Each holder of our Class B shares will be entitled to exercise its redemption right for two months from the first date of settlement of the tender offer triggering the redemption right by notifying us of its decision. We will ensure that mechanisms are in place so that the notification of the exercise of the redemption right may be made through Iberclear.

· The redemption price to be paid by us for each Class B share for which the redemption right has been exercised will be the sum of (i) the amount in euro of the highest consideration paid in the tender offer triggering the redemption right plus (ii) interest on the amount referred to in (i), from the date such tender offer is first settled until the date of full payment of the redemption price, at a rate equal to the one-year EURIBOR plus 300 basis points. For the purposes of this calculation, the amount in euro corresponding to any non-cash consideration paid in the tender offer will be the market value of such non-cash consideration as of the date the tender offer is first settled. The calculation of such market value shall be supported by at least two independent experts designated by us from auditing firms of international repute.

· We will, within 40 days of the date on which the period for notification of the exercise of redemption rights following a tender offer lapses, take all the necessary actions to (i) effectively pay the redemption price for our Class B shares for which the redemption right has been exercised and complete the capital reduction required for the redemption and (ii) reflect the amendment to Article 6 of the Articles of Association (related to share capital) deriving from the redemption.

The number of our Class B shares redeemed shall not represent a percentage over our total Class B shares issued and outstanding at the time the tender offer is made in excess of the percentage that the sum of our Class A shares (i) to which the tender offer is addressed, (ii) held by the offerors in that offer and (iii) held by persons acting in concert with the offerors or by persons having reached an agreement relating to the offer with the offerors represent over the total Class A shares issued and outstanding at the time the tender offer causing the redemption of our Class B shares is made.

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Payment of the redemption price will be subject to us having sufficient distributable reserves but, after a tender offer occurs and until the redemption price for our Class B shares is paid in full, we will not be able to declare or pay any dividends nor any other distributions to our shareholders (in each case, whether in cash, securities of Grifols or any of our subsidiaries, or any other securities, assets or rights).

Liquidation Rights

Each Class B share entitles its holder to receive, upon our winding-up and liquidation, an amount equal to the sum of (i) the nominal value of such Class B share and (ii) the share premium paid up for such Class B share when it was subscribed for.

We will pay the liquidation amount to the holders of our Class B shares before any amount on account of liquidation is paid to the holders of our Class A shares.

Each of our Class B shares entitles its holder to receive, in addition to the liquidation preference amount, the same liquidation amount paid for a Class A share.

Subscription Rights

Each Class B share entitles its holder to the same rights (including preferential subscription rights and free allotment rights) as one Class A share in connection with any issuance, granting or sale of (i) any shares in Grifols, (ii) any rights or other securities exercisable for, exchangeable or convertible into shares in Grifols or (iii) any options, warrants or other instruments giving the right to the holder thereof to purchase, convert, subscribe or otherwise receive any securities in Grifols.

As an exception, the preferential subscription rights and the free allotment rights of the Class B shares will only be for new Class B shares or for instruments giving the right to purchase, convert, subscribe for or otherwise receive Class B shares, and the preferential subscription right and the free allotment right of an Class A share will only be for new Class A shares or for instruments giving the right to purchase, convert, subscribe or otherwise receive Class A shares, for each capital increase or issuance that meets the following three requirements: (i) the issuance of Class A shares and Class B shares is in the same proportion of our share capital as they represent at the time the resolution on the capital increase is passed; (ii) grants of preferential subscription rights or free allotment rights, as applicable, to the Class B shares for the Class B shares are under the same terms as the preferential subscription rights or free allotment rights, as applicable, granted to the Class A shares for the Class A shares; and (iii) no other shares or securities are issued.

Registration and Transfers

Class B shares are in book-entry form on Iberclear and are indivisible, as indicated with respect to Class A shares above in “— Class A Shares — Registration and Transfers.”

Change in Control

The Articles of Association do not contain any provisions that would have the effect of delaying, deferring or preventing a change in control of Grifols.

Changes in Share Capital

Changes in share capital are considered extraordinary matters and must be approved by our shareholders in accordance with the procedures explained above in “— Class A Shares — Shareholders’ Meetings and Voting Rights” and “— Class B Shares — Separate Vote at General Shareholder Meetings on Extraordinary Matters.”

A capital increase may be effected by issuing new shares or by increasing the par value of existing shares. A capital reduction may be effected by reducing the par value of existing shares or by redeeming or repurchasing existing shares.

At the general shareholders’ meeting on extraordinary matters held on December 4, 2012, our shareholders agreed to increase share capital by issuing an additional 16,328,212 Class B shares, without a share premium and with a charge to voluntary reserves, in order to remunerate the Class A and Class B shareholders. The issuance took the form of a free allocation of one new Class B share for every 20 Class A or Class B shares owned. The issuance of these shares increased share capital by a nominal amount of €1.63 million.

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Also, at the general shareholders’ meeting on extraordinary matters held on December 4, 2012, our shareholders authorized the Board to increase share capital up to 50% of the existing share capital at that time. Within this authorization, on April 16, 2013, the Board adopted an increase by issuing an additional 884,997 Class B shares, with a share premium of €23.02, in order to pay half of the purchase price of the Progenika acquisition. The issuance of these shares increased share capital by a nominal amount of €0.09 million.

On January 4, 2016, the two-to-one share split of our existing Class A and Class B shares approved by the Board on December 3, 2015, became effective. The split reduced the nominal value of the shares by half, thus increasing the number of such shares, without changing the total nominal value of the share capital in accordance with the delegation of authorities granted to the Board by the Company’s general shareholders’ meeting held on May 29, 2015. As a result of the split, 426,129,798 Class A Shares are now issued and outstanding with a par value of €0.25 per share and 261,425,110 Class B Shares are now issued and outstanding with a par value of €0.05 per share. Our total share capital stands at €119,603,705.

Sinking Fund

The Articles of Association do not contain any sinking fund provisions.

C. Material Contracts

The following contracts have been entered into by us within the two years immediately preceding the date of this annual report on Form 20-F or contain provisions under which we or another member of the Grifols Group has an obligation or entitlement that is material to us:

2017 Notes

For a summary of the material terms of the 2017 Notes, see Item 5 of this Part I, “Operating and Financial Review and Prospects — B. Liquidity and Capital Resources — Sources of Credit —The 2017 Notes.”

New Credit Facilities

For a summary of the material terms of the New Credit Facilities, see Item 5 of this Part I, “Operating and Financial Review and Prospects — B. Liquidity and Capital Resources — Sources of Credit — New Credit Facilities.”

European Investment Bank Term Loans

For a summary of the material terms of the European Investment Bank Term Loans, see Item 5 of this Part I, “Operating and Financial Review and Prospects — B. Liquidity and Capital Resources — Sources of Credit — European Investment Bank Term Loans.”

Acquisitions and Related Financing

For a summary of the material terms of our acquisitions and related financing transactions substantially completed in 2016 and 2017, see Item 4 of this Part I, “Information of the Company — A. History of and Development of the Company — Acquisitions and Related Financing.”

D. Exchange Controls

Restrictions on Foreign Investment

Under present regulations, foreign investors may transfer invested capital, capital gains and dividends out of Spain without limitation on the amount other than applicable taxes. Law 19/2003, of July 4, 2003, updated Spanish exchange control and money laundering prevention provisions, by recognizing the principle of freedom of the movement of capital between Spanish residents and nonresidents.

The law establishes procedures for the declaration of capital movements for purposes of administrative or statistical information and authorizes the Spanish government to take measures which are justified on grounds of public policy or public security. It also provides the mechanism to take exceptional measures with regard to third countries if such measures have been approved by the European Union or by an international organization to which Spain is a party.

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The Spanish Stock Exchanges and securities markets are open to foreign investors. Royal Decree 664/1999, on Foreign Investments, of April 23, 1999, established a new framework for the regulation of foreign investments in Spain that, on a general basis, no longer requires any prior consents or authorizations from authorities in Spain (without prejudice to specific regulations for several specific sectors, such as television, radio, mining, telecommunications, etc.). Royal Decree 664/1999 requires notification of all foreign investments in Spain and liquidations of such investments upon completion of such investments to the Investments Registry of the Ministry of Economy and Finance, strictly for administrative statistical and economical purposes. Where the investment or divestiture is made in shares of a Spanish company listed on any of the Spanish Stock Exchanges, the duty to provide notice of a foreign investment or divestiture lies with the relevant entity with whom the shares (in book-entry form) have been deposited or that has acted as an intermediary in connection with the investment or divestiture.

Only investments from tax haven countries require notice before and after execution of the investment, except that no prior notice is required for: (i) investments in listed or publicly negotiable securities or in participations in collective investment schemes that are registered with the CNMV and (ii) investments that do not increase the foreign ownership of the share capital of a Spanish company to over 50%. In specific instances, the Council of Ministers may agree to suspend all or part of Royal Decree 664/1999 following a proposal of the Ministry of Economy and Finance, or, in some cases, a proposal by the head of the government department with authority for such matters and a report of the Foreign Investment Body. These specific instances include a determination that the investments, due to their nature, form or condition, affect or may potentially affect activities relating to the exercise of public powers, national security or public health. Royal Decree 664/1999 is currently suspended for investments relating to national defense. In those cases in respect of which Royal Decree 664/1999 is suspended, the affected investor must obtain prior administrative authorization in order to carry out the investment.

Exchange Controls

Law 10/2010, on the prevention of money laundering and funding of terrorism, was adopted on April 28, 2010 and entered into force on April 30, 2010. This Law requires a person moving (i) paper money and coins in any currency, (ii) bearer checks in any currency or (iii) any other physical medium, including electronic media, designed for use as payment to the bearer to declare such payment to the Spanish exchange control authorities if it exceeds €10,000 (or the foreign currency equivalent).

E. Taxation

In General

Treatment of Holders of ADSs

This section describes the material United States federal income and Spanish tax consequences of owning shares or ADSs. It applies to you only if you hold your shares or ADSs as capital assets for tax purposes. This section does not apply to you if you are a member of a special class of holders subject to special rules, including:

· a dealer in securities;

· a trader in securities that elects to use a mark-to-market method of accounting for securities holdings;

· a tax-exempt organization;

· a life insurance company;

· a person liable for alternative minimum tax under the Code (as defined below);

· a person that actually or constructively owns 10% or more of our voting stock;

· a person that holds shares or ADSs as part of a straddle or a hedging or conversion transaction; or

· a U.S. Holder (as defined below) whose functional currency is not the U.S. dollar.

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This section is based on the Internal Revenue Code of 1986, as amended, or the Code, its legislative history, existing and proposed regulations, published rulings and court decisions, in each case as in effect as of the date hereof and all of which are subject to change, possibly on a retroactive basis, as well as the tax laws of Spain and regulations thereunder and the Convention Between the United States of America and the Kingdom of Spain for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income, or the Treaty, in each case as in effect as of the date hereof and subject to change. On January 14, 2013, the United States and Spain signed a protocol amending the Treaty, or the Protocol, which, depending on a holder’s individual circumstances, could alter either the United States federal income tax consequences, the Spanish tax consequences, or both, of owning shares or ADSs. However, the Protocol will not become effective until formal ratification procedures are completed by both countries, and the timing for the completion of such ratification procedures is not certain. As a result, it is not certain when any changes to the United States federal income tax consequences or Spanish tax consequences of owning shares of ADSs resulting from the Protocol would come into effect, and in any case such changes would, in general, be prospective only.

You are a “U.S. Holder” if you are a beneficial owner of shares or ADSs and you are:

· a citizen or resident of the United States;

· a corporation or other entity taxable as a corporation, created or organized in or under the laws of the United States, any state thereof or the District of Columbia;

· an estate whose income is subject to United States federal income tax regardless of its source; or

· a trust if a United States court can exercise primary supervision over the trust’s administration and one or more United States persons are authorized to control all substantial decisions of the trust.

An “eligible U.S. Holder” is a U.S. Holder that:

· is a resident of the United States for purposes of the Treaty;

· does not maintain a permanent establishment or fixed base in Spain to which shares or ADSs are attributable and through which the U.S. Holder carries on or has carried on business (or, in the case of an individual, performs or has performed independent personal services); and

· is otherwise eligible for benefits under the Treaty with respect to income and gain from the shares or ADSs.

A “non-U.S. Holder” is a beneficial owner of shares or ADSs that is not a U.S. Holder.

In addition, if a partnership (including any entity treated as a partnership for United States federal income tax purposes) is a beneficial owner of shares or ADSs, the tax treatment of a partner in the partnership will generally depend upon the status of the partner and the activities of the partnership. A beneficial owner of shares or ADSs that is a partnership, and partners in such partnership, should consult their own tax advisors regarding the tax consequences of owning and disposing of shares or ADSs.

You should consult your own tax advisor regarding the United States federal, state and local and the Spanish and other tax consequences of owning and disposing of shares and ADSs in your particular circumstances. In particular, you should confirm your status as an eligible U.S. Holder with your advisor and should discuss any possible consequences of failing to qualify as an eligible U.S. Holder.

This discussion addresses only United States federal income taxation and Spanish income taxation, gift and inheritance taxation, wealth taxation and transfer taxation.

Treatment of Holders of ADRs

In general, and taking into account the earlier assumptions, for United States federal income and Spanish tax purposes, if you hold ADRs evidencing ADSs, you will be treated as the owner of the shares represented by those ADRs. Exchanges of shares for ADRs, and ADRs for shares, generally will not be subject to United States federal income or to Spanish tax.

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Spanish Tax Considerations

This discussion of Spanish tax consequences applies only to owners of ADSs or shares who are eligible U.S. Holders. The following is a summary of material Spanish tax matters and is not exhaustive of all the possible tax consequences to individuals or entities of the acquisition, ownership and disposition of ADSs or shares.

Taxation of Dividends

Under Spanish law, including Royal Legislative Decree 5/2004, of March 5, 2004, as amended by Law 26/2014 (which is effective from January 1, 2015), on the Non-Resident Income Tax Law, dividends paid by a Spanish resident company to a holder of ordinary shares or ADSs not residing in Spain for tax purposes and not operating through a permanent establishment in Spain are subject to Spanish Non-Resident Income Tax of 19%, effective January 1, 2016.

We will levy an initial withholding tax on the gross amount of dividends at a 19% tax rate, following the procedures set forth by the Spanish Ministerial Order, or Order, of April 13, 2000. However, under the Treaty and subject to the fulfillment of certain requirements, individuals and entities may be entitled to a reduced rate of 15%.

To benefit from the Treaty’s reduced rate of 15%, an individual or entity must provide the depositary with a certificate from the U.S. Internal Revenue Service, or IRS, stating that, to the knowledge of the IRS, it is a resident of the United States within the meaning of the Treaty. The IRS certificate may be obtained by filing an IRS Form 8802 and is valid for a period of one year.

According to the Order of April 13, 2000, to get a direct application of the Treaty’s reduced rate of 15%, the certificate referred to above must be provided to the depositary before the tenth day following the end of the month in which the dividends were distributable by us. If an individual or entity fails to timely provide the depositary with the required documentation, it may obtain a refund of the 4% (effective January 1, 2016) in excess withholding that would result from the Spanish tax authorities in accordance with the procedures below.

Spanish Refund Procedure

According to Royal Decree 1776/2004, of July 30, 2004, as amended, which further develops the Royal Legislative Decree 5/2004 on the Non-Resident Income Tax Law, a refund of the amount withheld in excess of the rate provided by the Treaty can be obtained from the relevant Spanish tax authorities. An eligible U.S. Holder may pursue the refund claim by filing all of the following:

· a Spanish 210 Form;

· the certificate from the IRS referred to above in “— Taxation of Dividends”; and

· evidence that non-resident income tax was withheld with respect to it.

The refund claim must be filed within four years of the date on which the withheld tax was collected by the Spanish tax authorities. According to Order EHA/3316, of December 17, 2010, for dividends paid as of January 2011, the 210 Form must be filed as from February 1st of the calendar year following the year in which the dividend was paid.

Individuals and entities are urged to consult their own tax advisers regarding refund procedures and any U.S. tax implications of refund procedures.

Taxation of Capital Gains

Under Spanish law, any capital gains derived from securities issued by persons residing in Spain for tax purposes are considered to be Spanish source income and, therefore, are taxable in Spain. For U.S. residents, income from the sale of ADSs or shares will be treated as capital gains for Spanish tax purposes. Effective January 1, 2016, Spanish Non-Resident Income Tax is levied at a 19% rate on capital gains realized by persons not residing in Spain for tax purposes who are not entitled to the benefit of any applicable treaty for the avoidance of double taxation.

Notwithstanding the above, capital gains derived from the transfer of shares on an official Spanish secondary securities market by any holder who is a resident of a country that has entered into a treaty for the avoidance of double taxation with Spain containing a clause of “exchange of information” (as defined in Law 36/2006, of November 30, 2006, related to measures to prevent tax fraud) will be exempt from taxation in Spain. In addition, under the Treaty, capital gains realized by an individual or entity upon

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the disposition of ADSs or shares will not be taxed in Spain provided that the individual or entity has not held, directly or indirectly, 25% or more of our stock during the twelve months preceding the disposition of the stock. An individual or entity is required to establish that it is entitled to this exemption by providing to the relevant Spanish tax authorities an IRS certificate of residence in the United States, together with the appropriate Spanish 210 tax form, between January 1st and January 20th of the calendar year following the year in which the transfer of shares took place.

Spanish Wealth Tax

On September 16, 2011, Royal Decree 13/2011 approved the reintroduction of the Spanish wealth tax (originally introduced under Law 19/1991) for 2011 and 2012. The Spanish wealth tax has been extended to apply through 2018 (in 2013 pursuant to Law 16/2012, of December 27, 2012, adopting various tax measures aimed at strengthening public finances and economic activity, in 2014, pursuant to Law 22/2013, of December 23, 2013 on the General State Budget for 2014, in 2015 pursuant to Law 36/2014, of December 26, 2014, on the General State Budget for 2015, in 2016 pursuant to law 48/2015, of October 29, 2015, on the General State Budget for 2016, in 2017 pursuant to Royal Decree-Law 3/2016, of December 2, 2016, adopting measures in the tax field aimed at the consolidation of public finances and other urgent social security measures and in 2018 pursuant to law 6/2018, of July 3, 2018 on the General State Budget for 2018). As a result, individuals not residing in Spain who hold shares or ADSs located in Spain are subject to the Spanish wealth tax, which imposes a tax on property located in Spain on the last day of any year. The Spanish tax authorities may take the view that all shares of Spanish corporations and all ADSs representing such shares are located in Spain for Spanish tax purposes. If the tax authorities take this view, individuals subject to the Spanish wealth tax will be taxed at marginal rates of 0.2% to 2.5% (as published by the Spanish Ministry of Economy and Public Administrations) of the average market value of their shares or ADSs during the last quarter of the relevant year, subject to a tax-free allowance of €700,000.

An individual is required to file Spanish wealth tax forms if he or she has a positive wealth tax liability or has assets or rights in Spain valued, in the aggregate, at more than €2,000,000.

Spanish Inheritance and Gift Taxes

Under Law 29/1987, transfers of shares or ADSs upon death or by gift are subject to Spanish inheritance and gift taxes if the transferee is a resident of Spain for tax purposes, or if the shares or ADSs are located in Spain at the time of gift or death, or the rights attached thereto could be exercised or have to be fulfilled in the Spanish territory, regardless of the residence of the beneficiary. In this regard, the Spanish tax authorities may determine that all shares of Spanish corporations and all ADSs representing such shares are located in Spain for Spanish tax purposes. The applicable tax rate, after applying all relevant factors, ranges between 0% and 81.6% for individuals.

Effective January 1, 2016, gifts granted to corporations not resident in Spain are subject to Spanish Non-Resident Income Tax of 19% of the fair market value of the shares as a capital gain. If the donee is a United States corporation, the exclusions available under the Treaty described above in “— Taxation of Capital Gains” will be applicable.

Expenses of Transfer

Transfers of ADSs or shares will be exempt from any Spanish transfer tax or value-added tax. Additionally, no Spanish stamp tax will be levied on such transfers.

United States Federal Income Tax Considerations

Taxation of Dividends

U.S. Holders

Under the United States federal income tax laws, and subject to the passive foreign investment company, or PFIC, rules discussed below, if you are a U.S. Holder, the gross amount of any dividend (including any preferred dividends on our Class B shares) we pay out of our current or accumulated earnings and profits (as determined for United States federal income tax purposes) is subject to United States federal income taxation. If you are a noncorporate U.S. Holder, dividends (including any preferred dividends on our Class B shares) paid to you that constitute qualified dividend income will be taxable to you at a maximum tax rate of 20% provided that you hold the shares or ADSs for more than 60 days during the 121-day period beginning 60 days before the ex-dividend date and meet other holding period requirements. Dividends we pay (including any preferred dividends on our Class B shares) with respect to the shares or ADSs generally will be qualified dividend income.

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With respect to any dividend we pay (including any preferred dividends on our Class B shares) you must include any Spanish tax withheld from the dividend payment in the gross amount of such dividend even though you do not in fact receive it. Dividends are taxable to you when you, in the case of shares, or the Depositary, in the case of ADSs, receive such dividend, actually or constructively. Such dividends will not be eligible for the dividends-received deduction generally allowed to United States corporations in respect of dividends received from other United States corporations. The amount of a dividend distribution that you must include in your income as a U.S. Holder will be the U.S. dollar value of the euro payments made, determined at the spot euro/U.S. dollar rate on the date the dividend distribution is includible in your income, regardless of whether the payment is in fact converted into U.S. dollars. Generally, any gain or loss resulting from currency exchange fluctuations during the period from the date you include a dividend payment in income to the date you convert the payment into U.S. dollars will be treated as ordinary income or loss and will not be eligible for the special tax rate applicable to qualified dividend income. The gain or loss generally will be income or loss from sources within the United States for foreign tax credit limitation purposes. Distributions in excess of current and accumulated earnings and profits, as determined for United States federal income tax purposes, will be treated as a non-taxable return of capital to the extent of your basis in the shares or ADSs and thereafter as capital gain.

Subject to certain limitations, the Spanish tax withheld in accordance with the Treaty and paid over to Spain will be creditable or deductible against your United States federal income tax liability. Special rules apply in determining the foreign tax credit limitation with respect to dividends that are subject to the maximum 20% tax rate. To the extent a refund of the tax withheld is available to you under Spanish law or under the Treaty, the amount of tax withheld that is refundable will not be eligible for credit against your United States federal income tax liability. See “— Spanish Tax Considerations — Spanish Refund Procedure” above for the procedures for obtaining a tax refund.

Dividends will be income from sources outside the United States, and dividends paid will, depending on your circumstances, be “passive” or “general” income which, in either case, is treated separately from other types of income for purposes of computing the foreign tax credit allowable to you.

A U.S. Holder may make an election to treat all foreign taxes paid as deductible expenses in computing taxable income, rather than as a credit against tax, subject to generally applicable limitations. Such an election, once made, applies to all foreign taxes paid for the taxable year subject to the election. The rules governing foreign tax credits are complex and, therefore, U.S. Holders are strongly encouraged to consult their own tax advisors to determine whether they are subject to any special rules that may limit their ability to make effective use of foreign tax credits and whether or not an election would be appropriate based on their particular circumstances.

Non-U.S. Holders

If you are a non-U.S. Holder, dividends (including any preferred dividends on our Class B shares) paid to you in respect of shares or ADSs will not be subject to United States federal income tax unless such dividends are “effectively connected” with your conduct of a trade or business within the United States, and such dividends are attributable to a permanent establishment that you maintain in the United States if that is required by an applicable income tax treaty as a condition for subjecting you to United States taxation on a net income basis. In such cases you generally will be taxed in the same manner as a U.S. Holder. If you are a corporate non-U.S. Holder, “effectively connected” dividends may, under certain circumstances, be subject to an additional “branch profits tax” at a 30% rate or at a lower rate if you are eligible for the benefits of an income tax treaty that provides for a lower rate.

Taxation of Capital Gains

U.S. Holders

Subject to the PFIC rules discussed below, if you are a U.S. Holder and you sell or otherwise dispose of your shares or ADSs, you will recognize capital gain or loss for United States federal income tax purposes equal to the difference between the U.S. dollar value of the amount that you realize and your tax basis, determined in U.S. dollars, in your shares or ADSs. Capital gain of a noncorporate U.S. Holder is generally taxed at a maximum rate of 20% where such noncorporate U.S. Holder has a holding period greater than one year. Such gain or loss will generally be income or loss from sources within the United States for foreign tax credit limitation purposes.

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Non-U.S. Holders

If you are a non-U.S. Holder, you will not be subject to United States federal income tax on gain recognized on the sale or other disposition of your shares or ADSs unless:

· the gain is “effectively connected” with your conduct of a trade or business in the United States, and the gain is attributable to a permanent establishment that you maintain in the United States if that is required by an applicable income tax treaty as a condition for subjecting you to United States taxation on a net income basis; or

· you are an individual, you are present in the United States for 183 or more days in the taxable year of the sale, and certain other conditions exist.

If you are a corporate non-U.S. Holder, “effectively connected” gains that you recognize may also, under certain circumstances, be subject to an additional “branch profits tax” at a 30% rate or at a lower rate if you are eligible for the benefits of an income tax treaty that provides for a lower rate.

Passive Foreign Investment Company Considerations

We believe that our shares and ADSs should not be treated as stock of a PFIC for United States federal income tax purposes, but this conclusion is a factual determination that is made annually and thus may be subject to change. If we were to be treated as a PFIC, gain realized on the sale or other disposition of your shares or ADSs would in general not be treated as capital gain. Instead, if you are a U.S. Holder, you would be treated as if you had realized such gain and certain “excess distributions” ratably over your holding period for the shares or ADSs and would be taxed at the highest tax rate in effect for each such year to which the gain was allocated, together with an interest charge in respect of the tax attributable to each such year. With certain exceptions, your shares or ADSs will be treated as stock in a PFIC if we were a PFIC at any time during your holding period in your shares or ADSs. Certain elections may be available that would result in alternative treatments (such as mark-to-market or QEF treatment) of the ADSs or shares. Dividends that you receive from us will not be eligible for the special tax rates applicable to qualified dividend income if we are treated as a PFIC with respect to you either in the taxable year of the distribution or the preceding taxable year, but instead will be taxable at rates applicable to ordinary income.

Medicare Contribution Tax on Unearned Income

A U.S. Holder that is an individual is subject to a 3.8% tax on the lesser of (1) such U.S. Holder’s “net investment income” for the relevant taxable year and (2) the excess of such U.S. Holder’s modified adjusted gross income for the taxable year over a certain threshold (between $125,000 and $250,000, depending on the individual’s circumstances). A U.S. Holder that is an estate, or a trust that does not fall into a special class of trusts that is exempt from such tax, is subject to a 3.8% tax on the lesser of (1) such U.S. Holder’s undistributed “net investment income” for the relevant taxable year and (2) the excess of such U.S. Holder’s adjusted gross income for the taxable year over the amount at which the highest tax bracket begins for that taxable year (currently $7,500). A U.S. Holder’s net investment income will generally include, among other items, the amount of gross dividend income and the amount of any net gains from such U.S. Holder’s disposition of your shares or ADSs, unless such dividends or net gains are derived in the ordinary course of the conduct of a trade or business (other than a trade or business that consists of certain passive or trading activities). U.S. Holders that are individuals, estates or trusts should consult their own tax advisors regarding the applicability of this tax to income and gains in respect of their investment in the shares or ADSs.

Backup Withholding and Information Reporting

If you are a noncorporate U.S. Holder, information reporting requirements, on Internal Revenue Service Form 1099, generally will apply to:

· dividend payments or other taxable distributions made to you within the United States; and

· the payment of proceeds to you from the sale of shares or ADSs effected at a United States office of a broker.

Additionally, backup withholding may apply to such payments if you are a noncorporate U.S. Holder that:

· fails to provide an accurate taxpayer identification number;

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· is notified by the Internal Revenue Service that you have failed to report all interest and dividends required to be shown on your federal income tax returns; or

· in certain circumstances, fails to comply with applicable certification requirements.

If you are a non-U.S. Holder, you are generally exempt from backup withholding and information reporting requirements with respect to:

· dividend payments made to you outside the United States by us or another non-United States payor; and

· other dividend payments and the payment of the proceeds from the sale of shares or ADSs effected at a United States office of a broker, if the income associated with such payments is otherwise exempt from United States federal income tax; and:

· the payor or broker does not have actual knowledge or reason to know that you are a United States person and you have furnished the payor or broker one of the following:

· an Internal Revenue Service Form W-8BEN or an acceptable substitute form upon which you certify, under penalties of perjury, that you are a non-United States person, or

· other documentation upon which it may rely to treat the payments as made to a non-United States person in accordance with U.S. Treasury regulations, or

· you otherwise establish an exemption.

Payment of the proceeds from the sale of shares or ADSs effected at a foreign office of a broker generally will not be subject to information reporting or backup withholding. However, a sale of shares or ADSs that is effected at a foreign office of a broker will be subject to information reporting and backup withholding if:

· the proceeds are transferred to an account maintained by you in the United States;

· the payment of proceeds or the confirmation of the sale is mailed to you at a United States address; or

· the sale has some other specified connection with the United States as provided in U.S. Treasury regulations, unless the broker does not have actual knowledge or reason to know that you are a United States person and the documentation requirements described above are met or you otherwise establish an exemption.

In addition, a sale of shares or ADSs effected at a foreign office of a broker will be subject to information reporting if the broker is:

· a United States person;

· a controlled foreign corporation for United States federal income tax purposes;

· a foreign person 50% or more of whose gross income is effectively connected with the conduct of a United States trade or business for a specified three-year period; or

· a foreign partnership, if at any time during its tax year:

· one or more of its partners are “U.S. persons,” as defined in U.S. Treasury regulations, who in the aggregate hold more than 50% of the income or capital interest in the partnership, or

· such foreign partnership is engaged in the conduct of a United States trade or business, unless the broker does not have actual knowledge or reason to know that you are a United States person and the documentation requirements described above are met or you otherwise establish an exemption. Backup withholding will apply if the sale is subject to information reporting and the broker has actual knowledge that you are a United States person.

Backup withholding is not an additional tax. You generally may obtain a refund of any amounts withheld under the backup withholding rules that exceed your income tax liability by filing a refund claim with the United States Internal Revenue Service.

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Disclosure of Information with Respect to Foreign Financial Assets

Certain U.S. individuals who hold any interest in “specified foreign financial assets,” including our shares or ADSs, during such holder’s taxable year must attach to their U.S. tax return for such year certain information with respect to each such asset if the aggregate value of all of such assets exceeds $50,000 (or a higher dollar amount prescribed by the Internal Revenue Service), unless such shares or ADSs are held in an account maintained by a U.S. payor, such as a U.S. financial institution or the U.S. branch of a foreign bank or insurer. For this purpose, a “specified foreign financial asset” includes any depositary, custodial or other financial account maintained by a foreign financial institution, and certain assets that are not held in an account maintained by a financial institution, including any stock or security issued by a person other than a U.S. person. A taxpayer subject to these rules who fails to furnish the required information may be subject to a penalty of $10,000, and an additional penalty may apply if the failure continues for more than 90 days after the taxpayer is notified of such failure by the Internal Revenue Service, unless the taxpayer demonstrates a reasonable cause for such failure to comply. An accuracy-related penalty of 40% is imposed for an underpayment of tax that is attributable to an “undisclosed foreign financial asset understatement,” which for this purpose is the portion of the understatement of gross income for any taxable year that is attributable to any transaction involving an “undisclosed foreign financial asset,” including any asset that is subject to information reporting requirements under these rules, which would include our shares or ADSs if the dollar threshold described above were satisfied.

The applicable statute of limitations for assessment of U.S. federal income taxes is extended to six years if a taxpayer omits from gross income more than $5,000 and such omission is attributable to a foreign financial asset as to which reporting is required under the rules described in the preceding paragraph or would be so required if such rules were applied without regard to the dollar threshold or any other exceptions specified by the Internal Revenue Service. In addition, the statute of limitations will be suspended if a taxpayer fails to provide in a timely manner either information with respect to specified foreign financial assets required to be reported or the annual information reports required for holders of PFIC stock, including PFIC stock for which a QEF election is made. You should consult your own tax advisor concerning any obligation you may have to furnish information to the Internal Revenue Service as a result of holding our shares or ADSs.

Impact of U.S. Federal Tax Reform

On December 22, 2017, the President signed into law H.R.1, commonly referred to as the Tax Cuts and Jobs Act, which significantly changed the Internal Revenue Code, including, a reduction in the corporate income tax rate, a new limitation on the deductibility of interest expense, a new tax on certain deductible payments made by a U.S. corporation to its foreign affiliates in order to prevent base erosion and significant changes to the taxation of income earned from foreign sources and foreign subsidiaries. The Tax Cuts and Jobs Act also authorizes the IRS to issue regulations with respect to the new provisions. We cannot predict how the changes in the Tax Cuts and Jobs Act, or regulations or other guidance issued under it, might affect materially the value of any investment in the Company’s shares or ADSs. Investors should consult their own tax advisors regarding the effects of the Tax Cut and Jobs Act on an investment in the Company or its shares or ADSs.

F. Dividends and Paying Agents

Not Applicable.

G. Statement by Experts

Not Applicable.

H. Documents on Display

We are subject to the information requirements of the Exchange Act, except that, as a foreign private issuer, we are not subject to the proxy rules or the short-swing profit disclosure rules of the Exchange Act. In accordance with these information requirements, we file or furnish reports and other information with the SEC. Reports and other information filed or furnished by us with the SEC may be inspected and copied at the public reference facilities maintained by the SEC at Room 1024, 100 F Street, N.E., Washington, D.C. 20549, and at the SEC’s regional offices at 233 Broadway, New York, New York 10279 and Northwestern Atrium Center, 500 West Madison Street, Suite 1400, Chicago, Illinois 60661-2511.

Copies of such material may also be inspected at the offices of NASDAQ, 4 Times Square, New York, New York 10036, on which our ADSs are listed. In addition, information filed electronically with the SEC is publicly available on the SEC’s website, which does not form part of this annual report on Form 20-F, at http://www.sec.gov.

I. Subsidiary Information

Not Applicable.

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Item 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The risks inherent in our market-sensitive instruments are potential losses that may arise from adverse changes to interest rates, foreign exchange rates and market prices. We are subject to market risk resulting from changes in interest rates because such changes may affect the cost at which we obtain financing. We are subject to exchange rate risk with respect to our debt denominated in foreign currencies.

Currency Risk

We operate internationally and are exposed to currency risks when operating in foreign currencies, in particular with respect to the U.S. dollar. Currency risk is associated with future commercial transactions, recognized assets and liabilities and net investments in foreign operations.

We hold several investments in foreign operations, the net assets of which are exposed to currency risk. Currency risk affecting net assets of our foreign operations in U.S. dollars are mitigated primarily through borrowings in the relevant foreign currency. Our main exposure to currency risk is to the U.S. dollar, which is used in a significant percentage of our transactions in foreign currencies.

If the U.S. dollar had strengthened by 10% against the euro at December 31, 2018, equity would have increased by €506.1 million (€416.1 million at December 31, 2017) and profit would have increased by €4.1 million (€14.6 million at December 31, 2017). This analysis assumes that all other variables are held constant, especially that interest rates remain constant. A 10% weakening of the U.S. dollar against the euro at December 31, 2018, and 2017, would have had the opposite effect for the amounts shown above, all other variables being held constant.

Interest Rate Risk

Our interest rate risks arise from current and non-current borrowings. Borrowings at variable interest rates expose us to cash flow interest rate risks. The purpose of managing interest rate risk is to balance the debt structure, maintaining part of borrowings at fixed rates and hedging part of variable rate debt.

A significant part of the financing obtained during 2018 accrues interest at fixed rates. This fixed interest debt amounts to €1,000 million as of December 31, 2018, which represents 54% of our total debt in euros. The additional loans of €244 million in the aggregate from the European Investment Bank represent 13% of our total debt in euros.

Our senior euro denominated debt represented 12% of our total senior debt at December 31, 2018 and at December 31, 2017. Total fixed-interest debt represented a total of 19% of debt at December 31, 2018, and 19% at December 31, 2017.

As of December 31, 2018, we were not participating in hedging of Euros or U.S. dollars. In previous years, the fair value of interest rate swaps, contracted to reduce the impact of rises in variable interest rates (LIBOR and EURIBOR), were accounted for on a monthly basis. These derivative financial instruments comply with hedge accounting requirements.

If the interest rate had been 100 basis points higher during 2018, the interest expense would have increased by €53 million. A 100 basis points decrease in interest rates during 2018 would have had the opposite effect for the amounts shown above.

Market Price Risk

We are subject to price risk with respect to raw materials, which is mitigated by the vertical integration of the hemoderivatives business in a sector that is highly concentrated.

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Item 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES.

A. Debt Securities

Not Applicable.

B. Warrants and Rights

Not Applicable.

C. Other Securities

Not Applicable.

D. American Depositary Shares

Deutsche Bank Trust Company Americas serves as the depositary for both our Class A ADSs and our Class B ADSs, and its principal executive office is located at 60 Wall Street, New York, NY 10005, USA. The custodian is Deutsche Bank Sociedad Anónima Española, and its principal office in Spain is located at Ronda General Mitre 72-74, 08017 Barcelona, Spain.

Each Class A ADS represents the right to receive one half of one Class A ordinary share of Grifols, S.A. Each Class B ADS represents the right to receive one Class B non-voting preference share of Grifols, S.A.

The following is a summary of the fee provisions of the deposit agreements for each of the Class A ADSs and Class B ADSs. For more complete information, you should read each deposit agreement in its entirety.

Associated Fee |  | Depositary Action
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs) |  | Issuance of ADSs, including issuance resulting from a distribution of shares or rights or other property. Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates.
$2.00 (or less) per 100 ADSs (or portion of 100 ADSs) |  | Distribution of cash proceeds, including cash dividends or sale of rights and other entitlements.
$2.00 (or less) per 100 ADSs (or portion of 100 ADSs) per calendar year, provided that this fee, when combined with the fee for distribution of cash proceeds, including cash dividends or sale of rights and other entitlements, shall not exceed $2.00 (or less) per 100 ADSs (or portion of 100 ADSs) in any calendar year |  | Depositary operation and maintenance costs.
Annual fee of $1.00 per 100 ADSs |  | Inspections of the relevant share register.
Registration or transfer fees |  | Transfer and registration of our shares on its share register to or from the name of the depositary or its agent when you deposit or withdraw our shares.
Expenses of the depositary |  | Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement). Converting foreign currency to U.S. dollars.
Taxes and other governmental charges the depositary or the custodian has to pay on any ADS or share underlying an ADS, including any applicable interest and penalties thereon and any share transfer or other taxes or governmental charges, for example, stock transfer taxes, stamp duty or withholding taxes |  | As necessary.

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Associated Fee |  | Depositary Action
Any fees and expenses incurred by the depositary in connection with the conversion of a foreign currency in compliance with the applicable exchange control and other regulations, and the delivery of deposited securities, including any fees of a central depository, and any additional fees, charges, costs, or expenses, that may be incurred by the depositary from time to time |  | As necessary.
Any additional fees, charges, costs or expenses that may be incurred by the depositary from time to time. |  | As necessary.

The depositary collects its fees for issuance and cancellation of our ADSs directly from investors depositing shares or surrendering our ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions, by directly billing investors or by charging the book-entry system accounts of participants acting for such investors. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid.

The fees and charges holders of our ADSs may be required to pay may vary over time and may be changed by us and by the depositary. Our ADS holders will receive prior notice of such changes.

Fees Paid by the Depositary to Grifols

Deutsche Bank Trust Company Americas, as depositary, has agreed to reimburse or pay on behalf of Grifols, S.A. certain reasonable expenses related to our ADR programs and incurred by us in connection with the programs, such as investor relations activities and ongoing maintenance expenses and listing fees. It has covered all such expenses incurred by us during 2018 for an amount of $1.7 million. The amounts the depositary reimbursed or paid are not perforce related to the fees it collected from ADS holders.

GLOSSARY OF TERMS

“AMP” means the average manufacturer price of certain outpatient drugs covered by Medicaid, as defined under the Medicaid drug rebate program, and is used to help calculate rebates paid by certain drug manufacturers that are shared by the U.S. and state governments.

“Alzheimer’s disease” is the most common form of dementia. This incurable, degenerative, and terminal disease was first described by German psychiatrist and neuropathologist Alois Alzheimer in 1906 and was named after him.

“Albumin” is the most abundant blood plasma protein and is produced in the liver and forms a large proportion of all plasma. Albumin normally constitutes about 60% of human plasma. It is important in regulating blood volume by maintaining the oncotic pressure of the blood compartment.

“ASP” means the average sales price of certain outpatient drugs covered by Medicare Part B, and is used to help calculate reimbursement of such drugs.

“Assays” are systems designed to detect antibodies, antigens or the nucleic acid of an infectious agent. For instance, the WNV assay detects the presence of the West Nile virus in blood donations. The main types of assay used for blood screening are Immunoassays and Nucleic acid technology, or NAT assays.

“A1PI” means alpha-1 proteinase inhibitor.

“BLA” (Biologics License Application) is a biological license application issued by the FDA, and serves as a U.S. marketing authorization for certain biological drug products.

“BlisPack” a blister handling machine.

“BLOODchip” blood group genotyping tests manufactured by Progenika, a company in which Grifols has a majority stake.

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“BP” means the best price, as defined under the Medicaid drug rebate program, and is used to help calculate rebates paid by certain drug manufacturers that are shared by the U.S. and state governments.

“cGMP” means current Good Marketing Practice.

“CIDP” means chronic inflammatory demyelinating polyneuropathy, a neurological disease resulting in weakness, numbness, pain and difficulty in walking.

“Cirrhosis” is a medical condition which is a result of advanced liver disease. It is characterized by the replacement of liver tissue by fibrosis (scar tissue) and regenerative nodules (lumps that occur due to attempted repair of damaged tissue).

“Congenital Alpha-1 Antitrypsin Deficiency” is an inherited disease characterized by reduced levels in the blood of the substance Alpha-1 Antitrypsin, or AAT. This substance is a protein that is normally made by the liver and reaches other organs (such as the lungs) after being released into the blood circulation.

“CMS” refers to the U.S. Centers for Medicare & Medicaid Services.

“CNMV” means the Comisión Nacional del Mercado de Valores.

“CPP” is the certificate of pharmaceutical product, a certificate issued in the format recommended by the WHO, which establishes the status of a pharmaceutical product and of the applicant for a certificate in the relevant exporting country.

“Diabetes” is a metabolic disease in which a person has high blood sugar, either because the pancreas does not produce enough insulin, or because cells do not respond to the insulin that is produced.

“DOJ” refers to the United States Department of Justice.

“ELISA” means enzyme-linked immunosorbent assay.

“EMA” refers to the European Medicines Agency.

“Erytra Eflexis” a fully automated, mid-size analyzer that performs pretransfusion compatibility testing using DG Gel technology.

“Factor VIII” or “FVIII” is an essential blood clotting factor also known as anti-haemophilic factor, or AHF. In humans, Factor VIII is encoded by the F8 gene. Defects in this gene results in hemophilia A, which is a sex-linked disease and occurs predominantly in males. FVIII concentrated from donated blood plasma, or alternatively recombinant FVIII, or rFVIII, can be given to hemophiliacs to restore hemostasis.

“Factor IX” is an important blood clotting factor also known as Christmas factor or plasma thromboplastin component, or PTC. It is one of the serine proteases of the coagulation system and belongs to the peptidase family S1. In humans, a deficiency of this protein causes haemophilia B, which is a sex-linked disease and occurs predominantly in males.

“FDA” is the U.S. Food and Drug Administration.

“Fibrin Glue or Fibrin Sealant” is surgical adhesive material that is utilized in a variety of surgical situations.

“Fractionation” is the process of fractionating plasma, or separating it into its different components or plasma derivatives.

“FSS” refers to the Federal Supply Schedule, a schedule managed by the U.S. Department of Veterans Affairs, which includes discounted drug pricing for certain U.S. government agency programs.

“GPO” means group purchasing organization.

“Gri-fill System”, a process for the sterile filling of flexible material bags.

“Hematology” is the study of blood, blood-forming organs, and blood diseases.

“Hemoderivative” is a substance obtained by fractionation of human blood plasma.

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“Hemophilia A” is a genetic deficiency in clotting factor VIII, which causes increased bleeding (usually affects males).

“Hemostasis” is a complex process which causes the bleeding process to stop. It refers to the process of keeping blood within a damaged blood vessel (the opposite of hemostasis is hemorrhage). Most of the time this includes the changing of blood from a fluid to a solid state. Intact blood vessels are central to moderating blood’s tendency to clot. Hemostasis has three major steps: 1) vasoconstriction, 2) temporary blockage of a break by a platelet plug, and 3) blood coagulation, or formation of a clot that seals the hole until tissue are repaired.

“HHS” refers to the U.S. Department of Health and Human Services.

“HIV” refers to the human immunodeficiency virus.

“Immunohematology” is a branch of hematology relating to the study of antigens and antibodies and their effects on blood and the relationships between disorders of the blood and the immune system.

“Immunology” is a broad branch of biomedical science that covers the study of all aspects of the immune system in organisms. It deals with the physiological functioning of the immune system in states of both health and disease; malfunctions of the immune system in immunological disorders (autoimmune diseases, hypersensitivities, immune deficiency, transplant rejection); the physical, chemical and physiological characteristics of the components of the immune system in vitro, in situ, and in vivo.

“IND” means investigational new drug application, which is an application that must be accepted by the FDA and in effect prior to certain drug sponsors commencing clinical trials involving human subjects.

“IRB” refers to institutional review boards, oversight committees that approve and monitor clinical trials to protect the rights and welfare of human subjects.

“ITP” means idiopathic thrombocytopenic purpura.

“IVIG” means intravenous immune globulin, which is a blood product administered intravenously. It contains the pooled IgG (immunoglobulin (antibody) G) extracted from plasma. It is mainly used as treatment in four major categories: (i) immune deficiencies, (ii) inflammatory and autoimmune diseases, (iii) neurological diseases and (iv) acute infections.

“Kawasaki disease” is a rare autoimmune disease that mostly affects children and causes inflammation of vessels, fever and rashes. This disease can be treated with IVIG.

“Koate-DVI” is

“Medicaid” is a social healthcare program in the United States for individuals with low income and resources.

“Medicare” is a national insurance program in the United States, primarily for persons 65 years old and over and certain younger persons with disabilities.

“Medicare Part B” is a portion of the Medicare program which includes, in part, reimbursement based on ASP for certain physician-administered drugs and drugs provided in the hospital outpatient setting.

“Medicare Part D” is a portion of the Medicare program which includes certain coverage for prescription drugs generally dispensed to patients by retail pharmacies.

“MRB” refers to the Market Research Bureau, Inc., an independent market research firm which supplies blood and plasma products industry data on a global level.

“NAT” means nucleic acid testing.

“NVD” means the share and asset agreement, executed with Novartis Vaccines and Diagnostics, Inc.

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“OIG” is the HHS Office of the Inspector General, which is charged with protecting the integrity of HSS programs, including the Medicare and Medicaid programs.

“Orphan drug” is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development The Orphan Drug Act (ODA) of January 1983, passed in the United States, with lobbying from the National Organization for Rare Disorders, is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market. Under the law, companies that develop such a drug (a drug for a disorder affecting fewer than 200,000 people in the United States) may sell it without competition for seven to ten years, and may get clinical trial tax incentives.

“Open Payments Program” imposes new reporting and disclosure requirements for pharmaceutical and medical device manufacturers with regard to payments or other transfers of value made to certain U.S. healthcare practitioners, such as physicians and academic medical centers, and with regard to certain ownership interests held by physicians in reporting entities.

“PDUFA” is the Prescription Drug User Fee Act, which levies a user fee on certain human drug applications.

“Plasma” is the liquid part of the blood. The majority of plasma is composed of water. The remainder is essential proteins and antibodies that help sustain our body’s vital functions. A shortage of any one of these plasma proteins, such as albumin or immunoglobulins, can give rise to one of many life-threatening illnesses.

“Plasmapheresis” is a technique which separates plasma from other blood components, such as red blood cells, platelets, and other cells. These unused blood components are suspended in saline solution and immediately re-injected back into the donor while the plasma collection process is taking place. Because the donor is only providing plasma and not whole blood, the recovery process is faster and better tolerated, and the donor is therefore able to make donations more frequently. Plasmapheresis was developed by Jose Antonio Grifols Lucas in the year 1951. It is the only procedure that is capable of obtaining sufficient quantities of plasma to cover the needs of manufacturing our many different plasma protein therapies.

“Plasma derivatives” are proteins found in human plasma, which once isolated and purified, have therapeutic value.

“PTC” means plasma thromboplastin component.

“Prolastin” is a concentrated form of alpha1-antitrypsin, or AAT, produced by Grifols and derived from human plasma and approved only for chronic, or ongoing, replacement therapy in people with emphysema caused by genetic AAT deficiency. Given as prescribed, Prolastin raises the levels of AAT in the blood and lungs. Raising the AAT level may help reduce the damage to the lungs caused by destructive enzymes.

“Promonitor” Highly specific ELISA kits for quantification of serum drug levels and anti-drug antibodies of various biological drugs

“Q-Coagulometer and Q-Smart analyzers” Fully automated hemostasis analyzers that use reagents to measure blood coagulation levels.

“Triturus analyzers” Open and fully automated analyzer for ELISA (enzyme-linked immunoabsorbent assay), tests with multi-test/multi-batch capability.

“Von Willebrand Disease” is the most common hereditary coagulation abnormality described in humans, although it can also be acquired as a result of other medical conditions. It arises from a qualitative or quantitative deficiency of von Willebrand factor, a multimeric protein that is required for platelet adhesion.

“WADiana/Erytra analyzers” Automated immunohematology analyzers that use gel agglutination technology to enable automatic processing of DG Gel® blood determination cards.

“WHO” refers to the world health organization.

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PART II

Item 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES

Not Applicable.

Item 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS

Not Applicable.

Item 15. CONTROLS AND PROCEDURES

A. Evaluation of Disclosure Controls and Procedures

Our Chief Executive Officers and our Chief Financial Officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of the end of the period covered by this annual report on Form 20-F, have concluded that, as of such date, our disclosure controls and procedures were effective.

B. Management’s Report on Internal Control over Financial Reporting

Our management, under the supervision of our Chief Executive Officer and our Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our internal control system is designed to provide reasonable assurance as to the reliability of financial reporting and the preparation of the published financial statements under generally accepted accounting principles. For Grifols, S.A., “generally accepted accounting principles” means IFRS as issued by IASB.

Our internal control over the financial reporting system includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of our Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles and that receipts and expenditures of our Company are being made only in accordance with authorizations of management and directors of our Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our Company assets that could have a material effect on the financial statements.

Internal control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers, or persons performing similar functions, and effected by our board of directors, management, and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS as issued by IASB. Internal control over financial reporting has inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements will not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2018. In making this assessment, they used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control — Integrated Framework (2013). Based on their assessment under these criteria, our management believes that, at December 31, 2018, our internal control over financial reporting is effective.

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C. Attestation Report of the Registered Public Accounting Firm

KPMG Auditores, S.L., an independent registered public accounting firm, who also audit the Group’s consolidated financial statements, has audited the effectiveness of Grifols S. A.’s internal control over financial reporting, and has issued an unqualified report thereon, which is included on page F-3 of this annual report on Form 20-F.

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D. Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during the period covered by this annual report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Item 16. [RESERVED]

Item 16.A. AUDIT COMMITTEE FINANCIAL EXPERT

The Board has determined that Steven F. Mayer is an “audit committee financial expert,” as defined in Item 16A of Form 20-F, and is an independent director under Rule 10A-3 under the Exchange Act.

Item 16.B. CODE OF ETHICS

We have adopted the Employee Code of Conduct, which applies to all of our employees, directors and officers, including our principal executive officer, principal financial officer and principal accounting officer. This Code is intended to meet the definition of “code of ethics” under Item 16B of Form 20-F.

If the Code of Conduct for Grifols’ Employees is amended, or if a waiver is granted, we will disclose such amendment or waiver on our website.

Item 16.C. PRINCIPAL ACCOUNTANT FEES AND SERVICES

The table below sets forth the total fees paid to KPMG Auditores, S.L., our principal accountants, and to other member firms of the KPMG international organization, for services performed in the years 2018 and 2017, and breaks down these amounts by category of service:

|  | 2018 |  | 2017 |
|  | (in thousands of euros) |
Audit fees |  | 5,000 |  | 4,983 |
Audit-related fees(1) |  | 373 |  | 626 |
Tax fees |  | 232 |  | 51 |
All other fees(2) |  | 228 |  | 7 |
Total |  | 5,833 |  | 5,667 |

(1) Audit-related fees are fees for assurance services or other work traditionally provided to us by external audit firms in their role as statutory auditors. 2017 fees mainly includes limited review of semi-annual financial statements for filing with the CNMV and a comfort letter delivered in connection with the refinancing of the notes.

(2) All other fees primarily relate to contract compliance services and training.

The table below sets forth the total fees paid to other auditors for services performed in the years 2018 and 2017, and breaks down these amounts by category of service:

|  | 2018 |  | 2017 |
|  | (in thousands of euros) |
Audit fees |  | 83 |  | 52 |
Audit-related fees |  | — |  | — |
Tax fees |  | — |  | — |
All other fees |  | — |  | — |
Total |  | 83 |  | 52 |

Pre-approval Policies and Procedures

Subject to shareholder approval of the independent auditor in accordance with Spanish law, the Audit Committee makes recommendations to the Board regarding the appointment, retainer and replacement of the independent auditor. The Audit Committee is also directly responsible for the compensation and oversight of the work of the independent auditor. We have developed a policy regarding the engagement of professional services by our external auditor, in accordance with the Spanish Audit Law and the Sarbanes-Oxley Act of 2002. This policy generally provides that we will not engage our independent auditors to render audit or non-audit services unless the service is specifically approved in advance by the Audit Committee.

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In accordance with the pre-approval policy, all audit and permitted non-audit services performed for us by our principal accountants, or any of its affiliates, were approved by the Audit Committee, which concluded that the provision of such services by the independent accountants was compatible with the maintenance of that firm’s independence in the conduct of its auditing functions.

Item 16.D. EXEMPTION FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES

Not applicable.

Item 16.E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS

The following table includes information about our share purchases during 2018:

Period |  | Total Number of Shares Purchased |  | Average Price Paid per Share |  | Total Number of Shares Purchased as Part of Publicly Announced Programs |  | Maximum Number of Shares that May Yet Be Purchased Under the Programs |
— |  | — |  | — |  | — |  | — |

As of December 31, 2018, we hold 3,818,451 Class B shares and no Class B ADS’s in treasury. There were no purchases during the year.

Item 16.F. CHANGES IN REGISTRANT’S CERTIFYING ACCOUNTANT

Not applicable.

Item 16.G. CORPORATE GOVERNANCE

Pursuant to NASDAQ Listing Rules, as a foreign private issuer, we may elect to follow our home country practice in lieu of the corporate governance requirements of the NASDAQ Listing Rule 5600 Series, with the exception of those rules that are required to be followed pursuant to the provisions of NASDAQ Listing Rule 5615(a)(3). We have elected to follow Spanish practices in lieu of the requirements of the NASDAQ Listing Rule 5600 Series to the extent permitted under NASDAQ Listing Rule 5615(a)(3). Set forth below is a summary of the significant differences between the corporate governance practices we follow under Spanish law (as in effect as of December 31, 2018) and those followed by NASDAQ-listed U.S. domestic issuers.

Corporate Governance

Under NASDAQ Listing Rules, a U.S. domestic issuer is required to establish a quorum as specified in its bylaws for any meeting of the holders of common stock, provided, however, that such quorum is not permitted to be less than 33 1/3% of the outstanding shares of voting stock. The Articles of Association provide that, on the first call of our general shareholders’ meetings, a duly constituted meeting requires a quorum of at least 25% of our subscribed share capital with voting rights, and, if a quorum is not obtained on the first call, a meeting is validly convened on the second call regardless of the share capital in attendance. However, certain major corporate actions (such as issuing additional ordinary shares, increasing or decreasing our share capital, issuing debt securities, amending the Articles of Association or approving merger transactions) require shareholder approval at a meeting at which at least 50% of our subscribed share capital with voting rights is present or represented on the first call or at least 25% of the share capital with voting rights present or represented on second call. However, when the number of shareholders attending our meeting represents less than 50% of our subscribed share capital with voting rights, resolutions on any of these major corporate actions must be adopted by the affirmative vote of at least two-thirds of the share capital present or represented at such meeting.

In addition, all actions described in Article 6.bis of the Articles of Association, which are considered to affect the economic rights of our Class B shares, must be approved at a shareholders’ meeting by the holders of at least a majority of Class B shares.

Under NASDAQ Listing Rules, U.S. domestic issuers are required to solicit proxies, provide proxy statements for all shareholders’ meetings and provide copies of such proxy materials to NASDAQ. As a foreign private issuer, we are generally exempt from the SEC rules governing the solicitation of shareholder proxies. However, under Spanish law and per the Articles of Association, we are required to publish a calling of the meeting at least one month prior to the date set for each general shareholders’ meeting in at least: (i) the Official Gazette of the Commercial Registry or one of the local newspapers of wide circulation in the province where we are domiciled (currently Barcelona, Spain); (ii) CNMV’s website; and (iii) our website. We distribute a copy of the notice of the meeting and a form of proxy to our U.S. shareholders and also make these materials available through our website in advance of such meeting.

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Under NASDAQ Listing Rules, shareholders of U.S. domestic issuers must be given the opportunity to vote on equity compensation plans and material revisions thereto, with limited exceptions set forth in NASDAQ Listing Rules, including an exception for foreign private issuers who follow the laws of their home country. Under Spanish law, equity compensation plans involving the issuance of our securities require prior shareholder approval. Additionally, equity compensation plans in which our officers and employees participate can be approved by the Board without shareholder approval. However, the establishment of equity compensation plans in which members of the Board participate must be authorized in the Articles of Association and requires the shareholders’ prior approval at a shareholders’ meeting.

Under NASDAQ Listing Rules, shareholders of U.S. domestic issuers must approve the issuance of securities when such issuance would result in a change in control of such issuer. Under Spanish law, any issuance of our securities, regardless of whether such issuance would result in a change of control, requires prior shareholder approval.

In Spain, companies with securities listed on a Spanish Stock Exchange are:

(i) recommended to follow the provisions of the CNMV Governance Code;

(ii) required by law to publish an Annual Report on Corporate Governance as well as corporate governance information on their websites;

(iii) required by law to publish an Annual Report on Remuneration of the members of the Board; and

(iv) required by law to comply with the regulations with respect to audit committees and appointment and remuneration committees set forth in the Spanish Companies Act, as amended.

Board Practices

Independence of Directors

Pursuant to NASDAQ Listing Rules, a majority of the directors of a listed U.S. company are required to be “independent,” as such term is defined by NASDAQ Listing Rules. As a foreign private issuer, we are exempt from such requirement, and Spanish law does not contain any such requirements.

Spanish law establishes the category of directors and the indispensable requirements to determine their independence. The Board Regulations, consistent with Spanish law, recognize two main categories of directors: (i) executive directors; and (ii) external directors, who can be divided into (a) proprietary directors, (b) independent directors and (c) other directors who cannot be considered proprietary or independent.

The definition of “independent director,” as set forth by Spanish law, provides that the persons listed below may not be nominated or designated as independent directors.

(i) Employees or executive directors of any Group companies, unless three or five years have elapsed, respectively, since the termination of the relationship.

(ii) Persons that have received some payment from us or from the Group in addition to their directors’ remuneration, unless the amount involved is not significant to the director. Dividends or pension supplements received by a director for prior employment or professional services are excluded, provided that such payments are non-contingent (i.e., the paying company has no discretionary power to suspend, modify or revoke the payment).

(iii) Persons that have been, during the last three years, partners of the external auditors or the firm responsible for the audit report, whether with respect to the audit of us or any other company in the Group for those years.

(iv) Executive directors or senior officers of other companies in which any of our executive directors or senior officers is an external director.

(v) Persons that have or had, during the last year, material business relationships with us or with any other company in the Group, whether in their own name or as a significant shareholder, director or senior officer of a company that has or had such a relationship. For purposes of this paragraph (v), “business relationships” means any relationship with suppliers of goods or services, including financial, advisory and consultancy services.

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(vi) Significant shareholders, executive directors or senior officers of an entity which receives or has received, during the last three years, significant donations from us or the Group. This provision does not apply to those who are merely trustees of a foundation receiving donations.

(vii) Spouses or related persons maintaining an analogous relationship or close relatives of one of our executive directors or senior officers.

(viii) Any person not proposed for appointment or renewal by the Appointments and Remuneration Committee.

(ix) Persons in any of the situations set out in (i), (v), (vi) or (vii) above with regard to a significant shareholder or a shareholder with Board representation. In the case of the family relations set out in (vii) above, the limitation applies not only in connection with the shareholder but also with our proprietary directors.

(x) Persons that have been directors for 12 consecutive years.

The proprietary directors who lose this status as a consequence of the sale of the shareholding by the shareholder they represent, can be reelected as independent directors only when such shareholder has sold the total amount of its shares.

Finally, any member of the Board that owns our shares can be considered independent, as long as the shareholding is not significant and satisfies all the above-mentioned conditions.

We have not determined whether our directors would be considered independent under NASDAQ Listing Rules, except for the three directors who are members of the Audit Committee and as such must meet NASDAQ independence criteria. As of the date of this report, seven members of the Board are independent directors in accordance with the Board Regulations and the CNMV Governance Code.

Furthermore, we follow the Spanish Companies Act, which does not, unlike NASDAQ Listing Rules, require independent directors to hold meetings where only such independent directors are present.

For a detailed discussion of the composition, responsibilities and terms of our Audit Committee, see Item 6 of Part I, “Directors, Senior Management and Employees — C. Board Practices — Committees of the Board — Audit Committee.”

Audit Committee

Responsibilities and Terms. In accordance with NASDAQ Listing Rules, our Audit Committee is in charge of the appointment, compensation, retention and oversight of the services of any registered public accounting firm engaged for the purpose of preparing and issuing any audit report, or for performing other audit reviews or related services. Notwithstanding the above, Spanish laws provide our shareholders with the authority to appoint and replace the independent auditor at a general shareholders’ meeting.

Independence of the Audit Committee. All of the members of our Audit Committee meet the independence criteria set out in NASDAQ Listing Rules. Subsequent to the entry into force of Law 31/2014 and Law 22/2015, Spanish law requires that (a) the Audit Committee be composed of external directors (the majority of them being independent and one of them being appointed due to his knowledge and experience in accounting or auditing matters) and (b) the chairman of the Audit Committee is an independent director. For a further discussion regarding the composition of our Audit Committee, see Item 6 of Part I, “Directors, Senior Management and Employees — C. Board Practices — Committees of the Board — Audit Committee.”

Internal Audit Department. We have an internal audit department responsible for internal audit matters and ensuring the efficiency of the internal audit control process of our different business units. Our internal audit department reports directly to the Audit Committee, supporting the adequate performance of all its functions.

Appointments and Remuneration Committee

Pursuant to NASDAQ Listing Rules, foreign private issuers are exempt from the requirements regarding independent nominating and compensation committees. Foreign private issuers are permitted to follow their home country corporate governance practice in this respect.

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Spanish law requires that all Spanish listed companies have an appointments and remuneration committee comprised of external directors, at least two of whom must be independent, and that the chairman of the appointments and remuneration committee be an independent director.

Our Appointments and Remuneration Committee is comprised exclusively of external directors and is chaired by an independent director. For a detailed discussion of our Appointments and Remuneration Committee, see Item 6 of Part I, “Directors, Senior Management and Employees — C. Board Practices — Committees of the Board — Appointments and Remuneration Committee.”

Internal Code of Conduct on Matters Related to the Securities Market and Business Ethics

Under NASDAQ Listing Rules, we are required to adopt a code of business conduct and ethics applicable to all directors, officers and employees, which must be publicly available. Under Spanish law, listed companies were previously required to have an internal code of conduct on matters related to the securities markets. However, with the entry into force of Royal Legislative Decree 19/2018, of November 23, 2018, on payment services and other urgent financial measures, this obligation has been removed.

Notwithstanding the above, Grifols will continue to apply the internal code of conduct for securities markets that was approved by the Board in its meeting held on October 28, 2016, in order to prevent insider trading, misconduct, and to control possible conflicts of interest.

Additionally, the Board Regulations set out in detail the directors’ main obligations relating to conflicts of interest concerning business opportunities, use of Grifols’ assets, confidentiality and non-competition. Both the Internal Code of Conduct on Matters Related to the Securities Market and the Board Regulations are publicly available on our website, which does not form part of this annual report on Form 20-F, at www.grifols.com. Although not mandatory under Spanish laws, the Board of Grifols also approved the Code of Conduct for Grifols Employees, which is publicly available on our website, which does not form part of this annual report on Form 20-F, at www.grifols.com.

Item 16.H. MINE SAFETY DISCLOSURE

Not applicable.

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PART III

Item 17. FINANCIAL STATEMENTS

We have elected to provide financial statements pursuant to Item 18 of this Part III.

Item 18. FINANCIAL STATEMENTS

The audited consolidated financial statements as required under Item 18 of this Part III are attached hereto starting on page F-1 of this annual report on Form 20-F. The audit report of KPMG, our independent registered public accounting firm, is included herein preceding the audited consolidated financial statements.

Item 19. EXHIBITS

Exhibit Number |  | Description
1.1 |  | Articles of Association (Estatutos) of Grifols, S.A. (English translation) (incorporated herein by reference to Exhibit 1.1 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 6, 2018)
2.1 |  | Amendment No. 1 to Deposit Agreement dated as of March 14, 2011 among Grifols, S.A., Deutsche Bank Trust Company Americas, as depositary, and all Holders from time to time of American Depositary Shares evidenced by American Depositary Receipts issued thereunder (incorporated herein by reference to Exhibit (a)(2) to our Registration Statement on Form F-6 (File No. 333-182636 filed July 12, 2012))
2.2 |  | Form of Deposit Agreement among Grifols, S.A., Deutsche Bank Trust Company Americas, as depositary, and all Holders from time to time of American Depositary Shares evidenced by American Depositary Receipts issued thereunder (incorporated herein by reference to Exhibit (a) to our Registration Statement on Form F-6 (File No. 333-172688) filed March 9, 2011)
2.3 |  | Form of Deposit Agreement among Grifols, S.A., Deutsche Bank Trust Company Americas, as depositary, and all Holders from time to time of American Depositary Shares evidenced by American Depositary Receipts issued thereunder (incorporated herein by reference to Exhibit (a) to our Registration Statement on Form F-6 (File No. 333-159327) filed May 18, 2009)
2.4 |  | Senior Notes Indenture, dated as of April 26, 2017, relating to the 3.20% Senior Notes due 2025, between Grifols S.A., the guarantors signatory thereto and BNY Mellon Corporate Trust Services Limited, as trustee (incorporated herein by reference to Exhibit 2.4 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 6, 2018)
2.5 |  | Form of 3.200% Senior Note (included as Exhibit A to Exhibit 2.4)
4.1 |  | Share and Asset Purchase Agreement, dated November 10, 2013, among Novartis Vaccines and Diagnostics, Inc., Novartis Corporation, Grifols Diagnostic Solutions Inc. (f/k/a G-C Diagnostics Corp.) and Grifols, S.A. (incorporated herein by reference to Exhibit 4.1 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 4, 2014)†
4.2 |  | Amendment No. 1 to Share and Asset Purchase Agreement, dated December 27, 2013, among Novartis Vaccines and Diagnostics, Inc., Novartis Corporation, Grifols Diagnostic Solutions Inc. and Grifols, S.A. (incorporated herein by reference to Exhibit 4.2 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 4, 2014)
4.3 |  | Amendment No. 2 to Share and Asset Purchase Agreement, dated January 9, 2014, among Novartis Vaccines and Diagnostics, Inc., Novartis Corporation, Grifols Diagnostic Solutions Inc. and Grifols, S.A. (incorporated herein by reference to Exhibit 4.3 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 4, 2014)†
4.4 |  | Asset Purchase Agreement by and among Hologic, Inc., Grifols Diagnostic Solutions, Inc. and Grifols, S.A., dated as of December 14, 2016 (incorporated herein by reference to Exhibit 4.4 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 6, 2018)
4.5 |  | Agreement for Assets Purchase by Share Issue by and between Shanghai RAAS Blood Products Co., Ltd. And Grifols, S.A., dated as of March 7, 2019*
4.6 |  | Credit and Guaranty Agreement, dated as of January 31, 2017, by and among Grifols Worldwide Operations Limited, Grifols Worldwide Operations USA, Inc., Grifols, S.A., certain subsidiaries of Grifols, S.A., the lenders party thereto and Bank of America, N.A., as administrative and collateral agent (incorporated herein by reference to Exhibit 4.12 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 4, 2017)
8.1 |  | List of subsidiaries (see Notes 1 and 2(b) to our audited consolidated financial statements starting on page F-11 of this annual report on Form 20-F)
10.1 |  | Plasma Supply Agreement, dated as of February 5, 2019, among Grifols, S.A., Grifols Worldwide Operations Limited, Biotest Pharmaceuticals Corporation and Haema AG*※
12.1 |  | Principal Executive Officer Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
12.2 |  | Principal Financial Officer Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*

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13.1 |  | Principal Executive Officer and Principal Financial Officer Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
101 |  | Interactive Data File

* Filed herewith.

† Portions of the exhibit have been omitted pursuant to an order granting confidential treatment dated June 30, 2014 by the Commission.

※ Confidential treatment is requested for certain confidential portions of this exhibit pursuant to Rule 24b-2 under the Exchange Act. In accordance with Rule 24b-2, these confidential portions have been omitted from this exhibit and filed separately with the SEC.

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GRIFOLS, S.A. AND SUBSIDIARIES

Consolidated Financial Statements

31 December 2018 and 2017

SUMMARY

· | Consolidated financial statements |
| · | Consolidated Balance Sheets | F-5
| · | Consolidated Statement of Profit or Loss | F-7
| · | Consolidated Statements of Comprehensive Income | F-8
| · | Consolidated Statements of Cash Flows | F-9
| · | Consolidated Statements of Changes in Equity | F-10
· | Notes |
| (1) | Nature, Principal Activities and Subsidiaries | F-12
| (2) | Basis of Presentation | F-12
| (3) | Business Combinations | F-20
| (4) | Significant Accounting Policies | F-27
| (5) | Financial Risk Management Policy | F-46
| (6) | Segment Reporting | F-49
| (7) | Goodwill | F-51
| (8) | Other Intangible Assets | F-53
| (9) | Property, Plant and Equipment | F-55
| (10) | Equity Accounted Investees | F-56
| (11) | Financial Assets | F-60
| (12) | Inventories | F-61
| (13) | Trade and Other Receivables | F-62
| (14) | Cash and Cash Equivalents | F-63
| (15) | Equity | F-63
| (16) | Earnings per Share | F-67
| (17) | Non-Controlling Interests | F-69
| (18) | Grants | F-69
| (19) | Provisions | F-70
| (20) | Financial Liabilities | F-71
| (21) | Trade and Other Payables | F-80
| (22) | Other Current Liabilities | F-80
| (23) | Net Revenues | F-80
| (24) | Personnel Expenses | F-83
| (25) | Expenses by Nature | F-83
| (26) | Finance Result | F-84
| (27) | Taxation | F-85
| (28) | Operating Leases | F-87
| (29) | Other Commitments with Third Parties and Other Contingent Liabilities | F-88
| (30) | Financial Instruments | F-91
| (31) | Balances and Transactions with Related Parties | F-97
| (32) | Subsequent Events | F-99

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Table of Contents

GRIFOLS, S.A. AND SUBSIDIARIES

Consolidated Financial Statements

31 December 2018 and 2017

SUMMARY

· | Appendices |
| · | Appendix I Information on Group Companies, Associates and Others | F-101
| · | Appendix II Operating Segments | F-107
| · | Appendix III Changes in Other Intangible Assets | F-109
| · | Appendix IV Movement in Property, Plant and Equipment | F-111
| · | Appendix V Statement of Liquidity for Distribution of Interim Dividend | F-113

F-2

Table of Contents

Report of Independent Registered Public Accounting Firm

To the Stockholders and Board of Directors of Grifols, S.A.

Opinions on the Consolidated Financial Statements and Internal Control Over Financial Reporting

We have audited the accompanying consolidated balance sheets of Grifols, S.A. and subsidiaries (the Company) as of 31 December 2018 and 2017, the related consolidated statements of profit and loss, comprehensive income, changes in consolidated equity, and cash flows for each of the years in the three-year period ended 31 December 2018, and the related notes and Appendix I to V (collectively, the consolidated financial statements). We also have audited the Company’s internal control over financial reporting as of 31 December 2018, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Grifols, S.A. and subsidiaries as of 31 December 2018 and 2017, and the results of its operations and its cash flows for each of the years in the three-year period ended 31 December 2018, in conformity with International Financial Reporting Standard as issued by the International Accounting Standard Board. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of 31 December 2018 based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Basis for Opinions

The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s consolidated financial statements and an opinion on the Company’s internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.

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Table of Contents

Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

Definition and Limitations of Internal Control Over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

/s/ KPMG Auditores, S.L. |

We have served as the Company’s auditor since 1990

Barcelona, Spain

5 April 2019

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GRIFOLS, S.A. AND SUBSIDIARIES

Consolidated Balance Sheets

at 31 December 2018 and 2017

(Expressed in thousands of Euros)

Assets |  | 31/12/18 |  | 31/12/17 |
Goodwill (note 7) |  | 5,209,230 |  | 4,590,498 |
Other intangible assets (note 8) |  | 1,385,537 |  | 1,269,342 |
Property, plant and equipment (note 9) |  | 1,951,983 |  | 1,760,053 |
Investments in equity-accounted investees (note 10) |  | 226,905 |  | 219,009 |
Non-current financial assets |  |  |  |  |
Non-current financial assets measured at fair value |  | 7 |  | 47,046 |
Non-current financial assets not measured at fair value |  | 107,594 |  | 22,843 |
Total non-current financial assets (note 11) |  | 107,601 |  | 69,889 |
Deferred tax assets (note 27) |  | 112,539 |  | 66,157 |
Total non-current assets |  | 8,993,795 |  | 7,974,948 |
Inventories (note 12) |  | 1,949,360 |  | 1,629,293 |
Trade and other receivables |  |  |  |  |
Trade receivables |  | 269,167 |  | 286,198 |
Other receivables |  | 92,418 |  | 40,681 |
Current income tax assets |  | 42,205 |  | 59,531 |
Trade and other receivables (note 13) |  | 403,790 |  | 386,410 |
Other current financial assets (note 11) |  |  |  |  |
Current financial assets measured at fair value |  | 19,934 |  | — |
Current financial assets not measured at fair value |  | 34,031 |  | 10,738 |
Total current financial assets (note 11) |  | 53,965 |  | 10,738 |
Other current assets |  | 42,344 |  | 32,354 |
Cash and cash equivalents (note 14) |  | 1,033,792 |  | 886,521 |
Total current assets |  | 3,483,251 |  | 2,945,316 |
Total assets |  | 12,477,046 |  | 10,920,264 |

The accompanying notes form an integral part of the consolidated financial statements.

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GRIFOLS, S.A. AND SUBSIDIARIES

Consolidated Balance Sheets

at 31 December 2018 and 2017

(Expressed in thousands of Euros)

Equity and liabilities |  | 31/12/18 |  | 31/12/17 |
Share capital |  | 119,604 |  | 119,604 |
Share premium |  | 910,728 |  | 910,728 |
Reserves |  | 2,441,931 |  | 2,027,648 |
Treasury stock |  | (55,441 | ) | (62,422 | )
Interim dividend |  | (136,747 | ) | (122,986 | )
Profit for the year attributable to the Parent |  | 596,642 |  | 662,700 |
Total equity |  | 3,876,717 |  | 3,535,272 |
Available for sale financial assets |  | — |  | 4,926 |
Other comprehensive Income |  | (554 | ) | (656 | )
Translation differences |  | 349,391 |  | 89,537 |
Other comprehensive expenses |  | 348,837 |  | 93,807 |
Equity attributable to the Parent (note 15) |  | 4,225,554 |  | 3,629,079 |
Non-controlling interests (note 17) |  | 471,050 |  | 4,886 |
Total equity |  | 4,696,604 |  | 3,633,965 |
Liabilities |  |  |  |  |
Grants (note 18) |  | 11,845 |  | 11,822 |
Provisions (note 19) |  | 6,114 |  | 5,763 |
Non-current financial liabilities (note 20) |  | 6,099,463 |  | 5,901,815 |
Other non-current liabilities |  | 1,301 |  | — |
Deferred tax liabilities (note 27) |  | 404,398 |  | 388,912 |
Total non-current liabilities |  | 6,523,121 |  | 6,308,312 |
Provisions (note 19) |  | 80,055 |  | 106,995 |
Current financial liabilities (note 20) |  | 277,382 |  | 155,070 |
Current debts with related companies |  | 7,079 |  | — |
Trade and other payables |  |  |  |  |
Suppliers |  | 561,883 |  | 423,096 |
Other payables |  | 159,816 |  | 141,720 |
Current income tax liabilities |  | 1,917 |  | 6,709 |
Total trade and other payables (note 21) |  | 723,616 |  | 571,525 |
Other current liabilities (note 22) |  | 169,189 |  | 144,397 |
Total current liabilities |  | 1,257,321 |  | 977,987 |
Total liabilities |  | 7,780,442 |  | 7,286,299 |
Total equity and liabilities |  | 12,477,046 |  | 10,920,264 |

The accompanying notes form an integral part of the consolidated financial statements.

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GRIFOLS, S.A. AND SUBSIDIARIES

Consolidated Statements of Profit and Loss

for the years ended 31 December 2018, 2017 and 2016

(Expressed in thousands of Euros)

|  | 31/12/18 |  | 31/12/17 |  | 31/12/16 |
Continuing Operations |  |  |  |  |  |  |
Net revenue (notes 6 and 23) |  | 4,486,724 |  | 4,318,073 |  | 4,049,830 |
Cost of sales |  | (2,437,164 | ) | (2,166,062 | ) | (2,137,539 | )
Gross Profit |  | 2,049,560 |  | 2,152,011 |  | 1,912,291 |
Research and Development |  | (240,661 | ) | (288,320 | ) | (197,617 | )
Selling, General and Administration expenses |  | (814,775 | ) | (860,348 | ) | (775,266 | )
Operating Expenses |  | (1,055,436 | ) | (1,148,668 | ) | (972,883 | )
Operating Result |  | 994,124 |  | 1,003,343 |  | 939,408 |
Finance income |  | 13,995 |  | 9,678 |  | 9,934 |
Finance costs |  | (293,273 | ) | (263,344 | ) | (244,829 | )
Change in fair value of financial instruments |  | — |  | (3,752 | ) | (7,610 | )
Impairment and gains /(losses) on disposal of financial instruments |  | 30,280 |  | (18,844 | ) | — |
Exchange differences |  | (8,246 | ) | (11,472 | ) | 8,916 |
Finance result (note 26) |  | (257,244 | ) | (287,734 | ) | (233,589 | )
Share of losses of equity accounted investees (note 10) |  | (11,038 | ) | (19,887 | ) | 6,933 |
Profit before income tax from continuing operations |  | 725,842 |  | 695,722 |  | 712,752 |
Income tax expense (note 27) |  | (131,436 | ) | (34,408 | ) | (168,209 | )
Profit after income tax from continuing operations |  | 594,406 |  | 661,314 |  | 544,543 |
Consolidated profit for the year |  | 594,406 |  | 661,314 |  | 544,543 |
Profit attributable to the Parent |  | 596,642 |  | 662,700 |  | 545,456 |
Loss attributable to non-controlling interest (note 17) |  | (2,236 | ) | (1,386 | ) | (913 | )
Basic earnings per share (Euros) (see note 16) |  | 0.87 |  | 0.97 |  | 0.80 |
Diluted earnings per share (Euros) (see note 16) |  | 0.87 |  | 0.97 |  | 0.80 |

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GRIFOLS, S.A. AND SUBSIDIARIES

Consolidated Statements of Comprehensive Income

for the years ended 31 December 2018, 2017 and 2016

(Expressed in thousands of Euros)

|  | 31/12/18 |  | 31/12/17 |  | 31/12/16 |
Consolidated profit for the year |  | 594,406 |  | 661,314 |  | 544,543 |
Items for reclassification to profit or loss |  |  |  |  |  |  |
Translation differences |  | 268,557 |  | (532,389 | ) | 103,833 |
Translation differences / Cash Flow Hedge |  | — |  | — |  | (6,809 | )
Available for sale financial Assets |  | — |  | 10,145 |  | (5,219 | )
Equity accounted investees (note 10) / Translation differences |  | (9,270 | ) | (27,134 | ) | 10,671 |
Cash flow hedges - effective part of changes in fair value |  | — |  | — |  | 14,501 |
Cash flow hedges - amounts taken to profit or loss |  | — |  | — |  | (7,426 | )
Other comprehensive income |  | 102 |  | (14 | ) | (4,810 | )
Tax effect |  | — |  | — |  | (2,462 | )
Other comprehensive income for the year, after tax |  | 259,389 |  | (549,392 | ) | 102,279 |
Total comprehensive income for the year |  | 853,795 |  | 111,922 |  | 646,822 |
Total comprehensive income attributable to the Parent |  | 856,598 |  | 113,441 |  | 647,667 |
Total comprehensive expense attributable to the non-controlling interests |  | (2,803 | ) | (1,519 | ) | (845 | )

The accompanying notes form an integral part of the consolidated financial statements.

F-8

Table of Contents

GRIFOLS, S.A. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

for the years ended 31 December 2018, 2017 and 2016

(Expressed in thousands of Euros)

|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Cash flows from operating activities |  |  |  |  |  |  |
Profit before tax |  | 725,842 |  | 695,722 |  | 712,752 |
Adjustments for: |  | 454,378 |  | 556,792 |  | 391,986 |
Amortization and depreciation (note 25) |  | 228,609 |  | 215,490 |  | 201,869 |
Other adjustments: |  | 225,769 |  | 341,302 |  | 190,117 |
(Profit) / losses on equity accounted investments (note 10) |  | 11,038 |  | 19,888 |  | (6,933 | )
Impairment of assets and net provision charges |  | (23,657 | ) | 66,047 |  | (23,079 | )
(Profit) / losses on disposal of fixed assets (note 8 and 9) |  | (6,700 | ) | 1,551 |  | (2,987 | )
Government grants taken to income (note 18) |  | (1,166 | ) | (286 | ) | (1,681 | )
Finance cost / (income) |  | 232,962 |  | 263,657 |  | 236,034 |
Other adjustments |  | 13,292 |  | (9,555 | ) | (11,237 | )
Change in operating assets and liabilities |  | (112,639 | ) | (65,800 | ) | (164,319 | )
Change in inventories |  | (231,670 | ) | (165,508 | ) | (173,003 | )
Change in trade and other receivables |  | (13,141 | ) | 80,112 |  | (25,180 | )
Change in current financial assets and other current assets |  | (3,092 | ) | (2,691 | ) | (2,610 | )
Change in current trade and other payables |  | 135,264 |  | 22,287 |  | 36,474 |
Other cash flows used in operating activities |  | (330,153 | ) | (344,968 | ) | (387,141 | )
Interest paid |  | (225,146 | ) | (207,079 | ) | (180,497 | )
Interest recovered |  | 6,862 |  | 9,492 |  | 8,685 |
Income tax (paid) / received |  | (111,585 | ) | (147,015 | ) | (215,329 | )
Other recovered (paid) |  | (284 | ) | (366 | ) | — |
Net cash from operating activities |  | 737,428 |  | 841,746 |  | 553,278 |
Cash flows from investing activities |  |  |  |  |  |  |
Payments for investments |  | (852,536 | ) | (2,209,667 | ) | (509,078 | )
Group companies, associates and business units (notes 3, 2 (b) and 10) |  | (524,081 | ) | (1,857,210 | ) | (202,727 | )
Property, plant and equipment and intangible assets |  | (307,722 | ) | (322,973 | ) | (292,690 | )
Property, plant and equipment |  | (231,983 | ) | (251,507 | ) | (249,416 | )
Intangible assets |  | (75,739 | ) | (71,466 | ) | (43,274 | )
Other financial assets |  | (20,733 | ) | (29,484 | ) | (13,661 | )
Proceeds from the sale of investments |  | 70,669 |  | 23,787 |  | 2,426 |
Property, plant and equipment |  | 550 |  | 762 |  | 2,426 |
Other financial assets |  | 70,119 |  | 23,025 |  | — |
Net cash used in investing activities |  | (781,867 | ) | (2,185,880 | ) | (506,652 | )
Cash flows from financing activities |  |  |  |  |  |  |
Proceeds from and payments for equity instruments |  | — |  | — |  | (11,766 | )
Payments for treasury stock (note 15 (d)) |  | — |  | — |  | (12,686 | )
Sales of treasury stock (note 15 (d)) |  | — |  | — |  | 920 |
Proceeds from and payments for financial liability instruments |  | 37,418 |  | 1,808,771 |  | (80,149 | )
Issue |  | 179,350 |  | 1,912,615 |  | 81,513 |
Redemption and repayment |  | (141,932 | ) | (103,844 | ) | (161,662 | )
Dividends and interest on other equity instruments |  | (275,783 | ) | (218,260 | ) | (216,151 | )
Dividends paid |  | (278,841 | ) | (218,260 | ) | (216,151 | )
Dividends received |  | 3,058 |  | — |  | — |
Other cash flows from / (used in) financing activities |  | 4,661 |  | (156,446 | ) | (21,492 | )
Financing costs included on the amortised costs of the debt |  | — |  | (142,288 | ) | — |
Other amounts from / (used in) financing activities |  | 4,661 |  | (14,158 | ) | (21,492 | )
Transaction with minority interests with no loss of control (note 3) |  | 386,207 |  | — |  | — |
Net cash from/(used in) financing activities |  | 152,503 |  | 1,434,065 |  | (329,558 | )
Effect of exchange rate fluctuations on cash |  | 39,207 |  | (98,419 | ) | 35,441 |
Net increase in cash and cash equivalents |  | 147,271 |  | (8,488 | ) | (247,491 | )
Cash and cash equivalents at beginning of the year |  | 886,521 |  | 895,009 |  | 1,142,500 |
Cash and cash equivalents at year end |  | 1,033,792 |  | 886,521 |  | 895,009 |

The accompanying notes form an integral part of the consolidated financial statements.

F-9

Table of Contents

GRIFOLS, S.A. AND SUBSIDIARIES

Statement of Changes in Consolidated Equity

for the years ended 31 December 2018, 2017 and 2016

(Expressed in thousands of Euros)

|  | Attributable to shareholders of the Parent |
|  |  |  |  |  |  |  |  |  |  |  |  |  | Accumulated other comprehensive income |  |  |  |  |  |  |
|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Equity |  |  |  |  |
|  |  |  |  |  |  |  | Profit attributable |  |  |  |  |  |  |  |  |  |  |  |  |  | attributable |  |  |  |  |
|  | Share |  | Share |  |  |  | to |  | Interim |  | Treasury |  | Translation |  | Available for sale |  | Other comprehensive |  | Cash flow |  | to |  | Non-controlling |  |  |
|  | capital |  | premium |  | Reserves |  | Parent |  | dividend |  | stock |  | differences |  | financial assets |  | income |  | hedges |  | Parent |  | interests |  | Equity |
Balance at 31 December 2015 |  | 119,604 |  | 910,728 |  | 1,371,061 |  | 532,145 |  | (119,615 | ) | (58,575 | ) | 534,491 |  | — |  | 3,035 |  | 3,329 |  | 3,296,203 |  | 5,187 |  | 3,301,390 |
Translation differences |  | — |  | — |  | — |  | — |  | — |  | — |  | 114,436 |  | — |  | — |  | — |  | 114,436 |  | 68 |  | 114,504 |
Available for sale financial assets |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (5,219 | ) | — |  | — |  | (5,219 | ) | — |  | (5,219 | )
Cash flow hedges (note 15 (f)) |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (3,329 | ) | (3,329 | ) | — |  | (3,329 | )
Other comprehensive income |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (3,677 | ) | — |  | (3,677 | ) | — |  | (3,677 | )
Other comprehensive income / (expense) for the year |  | — |  | — |  | — |  | — |  | — |  | — |  | 114,436 |  | (5,219 | ) | (3,677 | ) | (3,329 | ) | 102,211 |  | 68 |  | 102,279 |
Profit/(loss) for the year |  | — |  | — |  | — |  | 545,456 |  | — |  | — |  | — |  | — |  | — |  | — |  | 545,456 |  | (913 | ) | 544,543 |
Total comprehensive income / (expense) for the year |  | — |  | — |  | — |  | 545,456 |  | — |  | — |  | 114,436 |  | (5,219 | ) | (3,677 | ) | (3,329 | ) | 647,667 |  | (845 | ) | 646,822 |
Net change in treasury stock (note 15 (d)) |  | — |  | — |  | (182 | ) | — |  | — |  | (10,135 | ) | — |  | — |  | — |  | — |  | (10,317 | ) | — |  | (10,317 | )
Acquisition of non-controlling interests (note 15 (c)) |  | — |  | — |  | (2,737 | ) | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (2,737 | ) | 2,737 |  | — |
Other changes |  | — |  | — |  | 6,816 |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | 6,816 |  | (582 | ) | 6,234 |
Interim dividend |  | — |  | — |  | — |  | — |  | (122,908 | ) | — |  | — |  | — |  | — |  | — |  | (122,908 | ) | — |  | (122,908 | )
Distribution of 2015 profit |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Reserves |  | — |  | — |  | 319,287 |  | (319,287 | ) | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |
Dividends |  | — |  | — |  | — |  | (93,243 | ) | — |  | — |  | — |  | — |  | — |  | — |  | (93,243 | ) | — |  | (93,243 | )
Interim dividend |  | — |  | — |  | — |  | (119,615 | ) | 119,615 |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |
Operations with shareholders or owners |  | — |  | — |  | 323,184 |  | (532,145 | ) | (3,293 | ) | (10,135 | ) | — |  | — |  | — |  | — |  | (222,389 | ) | 2,155 |  | (220,234 | )

F-10

Table of Contents

GRIFOLS, S.A. AND SUBSIDIARIES

Statement of Changes in Consolidated Equity

for the years ended 31 December 2018, 2017 and 2016

(Expressed in thousands of Euros)

|  | Attributable to shareholders of the Parent |
|  |  |  |  |  |  |  |  |  |  |  |  |  | Accumulated other comprehensive income |  |  |  |  |  |  |
|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | Equity |  |  |  |  |
|  |  |  |  |  |  |  | Profit attributable |  |  |  |  |  |  |  |  |  |  |  |  |  | attributable |  |  |  |  |
|  | Share |  | Share |  |  |  | to |  | Interim |  | Treasury |  | Translation |  | Available for sale |  | Other comprehensive |  | Cash flow |  | to |  | Non-controlling |  |  |
|  | capital |  | premium |  | Reserves |  | Parent |  | dividend |  | stock |  | differences |  | financial assets |  | income |  | hedges |  | Parent |  | interests |  | Equity |
Balance at 31 December 2016 |  | 119,604 |  | 910,728 |  | 1,694,245 |  | 545,456 |  | (122,908 | ) | (68,710 | ) | 648,927 |  | (5,219 | ) | (642 | ) | — |  | 3,721,481 |  | 6,497 |  | 3,727,978 |
Translation differences |  | — |  | — |  | — |  | — |  | — |  | — |  | (559,390 | ) | — |  | — |  | — |  | (559,390 | ) | (133 | ) | (559,523 | )
Available for sale financial assets |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | 10,145 |  | — |  | — |  | 10,145 |  | — |  | 10,145 |
Other comprehensive income |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (14 | ) | — |  | (14 | ) | — |  | (14 | )
Other comprehensive income / (expense) for the year |  | — |  | — |  | — |  | — |  | — |  | — |  | (559,390 | ) | 10,145 |  | (14 | ) | — |  | (549,259 | ) | (133 | ) | (549,392 | )
Profit/(loss) for the year |  | — |  | — |  | — |  | 662,700 |  | — |  | — |  | — |  | — |  | — |  | — |  | 662,700 |  | (1,386 | ) | 661,314 |
Total comprehensive income / (expense) for the year |  | — |  | — |  | — |  | 662,700 |  | — |  | — |  | (559,390 | ) | 10,145 |  | (14 | ) | — |  | 113,441 |  | (1,519 | ) | 111,922 |
Net change in treasury stock (note 15 (d)) |  | — |  | — |  | — |  | — |  | — |  | 6,288 |  | — |  | — |  | — |  | — |  | 6,288 |  | — |  | 6,288 |
Acquisition of non-controlling interests (note 15 (c)) |  | — |  | — |  | (346 | ) | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (346 | ) | (43 | ) | (389 | )
Other changes |  | — |  | — |  | 6,475 |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | 6,475 |  | (49 | ) | 6,426 |
Interim dividend |  | — |  | — |  |  |  | — |  | (122,986 | ) | — |  | — |  | — |  | — |  | — |  | (122,986 | ) | — |  | (122,986 | )
Distribution of 2016 profit |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Reserves |  | — |  | — |  | 422,548 |  | (422,548 | ) | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |
Dividends |  | — |  | — |  | (95,274 | ) | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (95,274 | ) | — |  | (95,274 | )
Interim dividend |  | — |  | — |  | — |  | (122,908 | ) | 122,908 |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |
Operations with shareholders or owners |  | — |  | — |  | 333,403 |  | (545,456 | ) | (78 | ) | 6,288 |  | — |  | — |  | — |  | — |  | (205,843 | ) | (92 | ) | (205,935 | )
Balance at 31 December 2017 |  | 119,604 |  | 910,728 |  | 2,027,648 |  | 662,700 |  | (122,986 | ) | (62,422 | ) | 89,537 |  | 4,926 |  | (656 | ) | — |  | 3,629,079 |  | 4,886 |  | 3,633,965 |
Impact of new IFRS (note 2) |  | — |  | — |  | 29,562 |  | — |  | — |  | — |  | — |  | (4,926 | ) | — |  | — |  | 24,636 |  | — |  | 24,636 |
Balance at 31 December 2017 adjusted |  | 119,604 |  | 910,728 |  | 2,057,210 |  | 662,700 |  | (122,986 | ) | (62,422 | ) | 89,537 |  | 0 |  | (656 | ) | 0 |  | 3,653,715 |  | 4,886 |  | 3,658,601 |
Translation differences |  | — |  | — |  | — |  | — |  | — |  | — |  | 259,854 |  | — |  | — |  | — |  | 259,854 |  | (567 | ) | 259,287 |
Other comprehensive income |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | 102 |  | — |  | 102 |  | — |  | 102 |
Other comprehensive income / (expense) for the year |  | — |  | — |  | — |  | — |  | — |  | — |  | 259,854 |  | — |  | 102 |  | — |  | 259,956 |  | (567 | ) | 259,389 |
Profit/(loss) for the year |  | — |  | — |  | — |  | 596,642 |  | — |  | — |  | — |  | — |  | — |  | — |  | 596,642 |  | (2,236 | ) | 594,406 |
Total comprehensive income / (expense) for the year |  | — |  | — |  | — |  | 596,642 |  | — |  | — |  | 259,854 |  | — |  | 102 |  | — |  | 856,598 |  | (2,803 | ) | 853,795 |
Net change in treasury stock (note 15 (d)) |  | — |  | — |  | — |  | — |  | — |  | 6,981 |  | — |  | — |  | — |  | — |  | 6,981 |  | — |  | 6,981 |
Acquisition / Divestment of non-controlling interests (note 15 (c)) |  | — |  | — |  | (3,462 | ) | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (3,462 | ) | 469,010 |  | 465,548 |
Other changes |  | — |  | — |  | (9,437 | ) | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (9,437 | ) | (43 | ) | (9,480 | )
Interim dividend |  | — |  | — |  |  |  | — |  | (136,747 | ) | — |  | — |  | — |  | — |  | — |  | (136,747 | ) | — |  | (136,747 | )
Distribution of 2017 profit: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Reserves |  | — |  | — |  | 539,714 |  | (539,714 | ) | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |
Dividends |  | — |  | — |  | (142,094 | ) | — |  | — |  | — |  | — |  | — |  | — |  | — |  | (142,094 | ) | — |  | (142,094 | )
Interim dividend |  | — |  | — |  | — |  | (122,986 | ) | 122,986 |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |
Operations with shareholders or owners |  | — |  | — |  | 384,721 |  | (662,700 | ) | (13,761 | ) | 6,981 |  | — |  | — |  | — |  | — |  | (284,759 | ) | 468,967 |  | 184,208 |
Balance at 31 December 2018 |  | 119,604 |  | 910,728 |  | 2,441,931 |  | 596,642 |  | (136,747 | ) | (55,441 | ) | 349,391 |  | — |  | (554 | ) | — |  | 4,225,554 |  | 471,050 |  | 4,696,604 |

F-11

Table of Contents

GRIFOLS, S.A. AND SUBSIDIARIES

Notes to the Consolidated Financial statements

(1) Nature, Principal Activities and Subsidiaries

Grifols, S.A. (hereinafter the Company) was incorporated with limited liability under Spanish law on 22 June 1987. Its registered and tax offices are in Barcelona. The Company’s statutory activity consists of providing corporate and business administrative, management and control services, as well as investing in assets and property. Its principal activity involves rendering administrative, management and control services to its subsidiaries.

On 17 May 2006 the Company completed its flotation on the Spanish securities market, which was conducted through the public offering of 71,000,000 ordinary shares of Euros 0.50 par value each and a share premium of Euros 3.90 per share. The total capital increase (including the share premium) amounted to Euros 312.4 million, equivalent to a price of Euros 4.40 per share.

The Company’s shares were floated on the Spanish stock exchange IBEX-35 index on 2 January 2008.

All of the Company’s shares are listed on the Barcelona, Madrid, Valencia and Bilbao securities markets and on the Spanish Automated Quotation System (SIBE/Continuous Market). On 2 June 2011, Class B non-voting shares were listed on the NASDAQ (USA) and on the Spanish Automated Quotation System (SIBE/Continuous Market).

Grifols, S.A. is the Parent of the subsidiaries listed in Appendix I of this note to the consolidated Financial statements.

Grifols, S.A. and subsidiaries (hereinafter the Group) act on an integrated basis and under common management and their principal activity is the procurement, manufacture, preparation and sale of therapeutic products, especially haemoderivatives.

The main factory locations of the Group’s Spanish companies are in Parets del Vallés (Barcelona) and Torres de Cotilla (Murcia), while the US companies are located in Los Angeles (California), Clayton (North Carolina), Emeryville (California), and San Diego (California).

The Company aims to reinforce its strategic presence in China. In this regards, Grifols is currently in talks with Shangai RAAS Blood Products to explore a possible corporate transaction and reached an agreement with Boya-Pharmaceutical to open plasma centers in China.

(2) Basis of Presentation

The Consolidated Financial Statements have been prepared on the basis of the accounting records of Grifols, S.A. and of the Group companies. The Consolidated Financial Statements for 2018 have been prepared under International Financial Reporting Standards as issued by the International Accounting Standard Board (IFRS-IASB) which for Grifols Group purposes, are identical to the standards as endorsed by the International Financial Reporting Standards as adopted by the European Union (IFRS-EU) to present fairly the consolidated equity and consolidated financial position of Grifols, S.A. and subsidiaries at 31 December 2018, as well as the consolidated results from their operations, consolidated cash flows and consolidated changes in equity for the year then ended.

The Group adopted IFRS-EU for the first time on 1 January 2004 and has been preparing its Financial statements under International Financial Reporting Standards, as adopted by the European Union (IFRS-EU) as required by capital market regulations governing the presentation of financial statements by companies whose debt or own equity instruments are listed on a regulated market.

The Board of Directors of Grifols, S.A. considers that these consolidated Financial statements of 2018 authorized for issue at their meeting held on 3 April 2019, will be approved by the shareholders without any modifications.

In accordance with the provision of section 357 of the Irish Companies Act 2014, the Company has irrevocably guaranteed all liabilities of an Irish subsidiary undertaking, Grifols Worldwide Operations Limited (Ireland) (see Appendix I), for the financial year ended 31 December 2018 as referred to in subsection 1(b) of that Act, for the purposes of enabling Grifols Worldwide Operations Limited to claim exemption from the requirement to file their own Financial statements in Ireland.

F-12

Table of Contents

GRIFOLS, S.A. AND SUBSIDIARIES

Notes to the Consolidated Financial statements

(a) Relevant accounting estimates, assumptions and judgments used when applying accounting principles

The preparation of the consolidated Financial statements in conformity with IFRS-IASB requires management to make judgments, estimates and assumptions that affect the application of Group accounting policies. The following notes include a summary of the relevant accounting estimates and judgments used to apply accounting policies which have the most significant effect on the amounts recognized in the consolidated Financial statements.

· Assumptions used to test non-current assets and goodwill for impairment. Relevant cash generating units are tested annually for impairment. These are based on risk-adjusted future cash flows discounted using appropriate interest rates. The key assumptions used are specified in note 7. Assumptions relating to risk-adjusted future cash flows and discount rates are based on business forecasts and are therefore inherently subjective. Future events could cause a change in business forecasts, with a consequent adverse effect on the future results of the Group. To the extent considered a reasonably possible change in key assumptions could result in an impairment of goodwill, a sensitivity analysis has been disclosed to show the effect of changes to these assumptions and the effect of the cash generating unit (CGU) on the recoverable amount.

· Determination the fair value of assets, liabilities and contingent liabilities related to business combinations. Details of the fair value methods used by the Group are provided in note 3.

· Evaluation of the capitalization of development costs (see note 4(h)). The key assumption is related to the estimation of sufficient future economic benefits of the projects.

· Evaluation of provisions and contingencies. Key assumptions relate to the evaluation of the likelihood of an outflow of resources due to a past event, as well as to the evaluation of the best estimate of the likely outcome. These estimates take into account the specific circumstances of each dispute and relevant external advice and therefore are inherently subjective and could change substantially over time as new facts arise and each dispute progresses. Details of the status of various uncertainties involved in significant unresolved disputes are set out in note 29.

· Evaluation of the recoverability of tax credits, including tax loss carryforwards and rights for deductions. Deferred tax assets are recognized to the extent that future taxable profits will be available against which the temporary differences can be utilized, based on management’s assumptions relating to the amount and timing of future taxable profits (see notes 4(t) and 27).

· Analysis that the refinancing of debt and bonds does not result in a new financial liability.

No changes have been made to prior year judgments relating to existing uncertainties.

The Group is also exposed to interest rate and currency risks. Refer to sensitivity analysis in note 30.

(b) Basis of consolidation

Appendix I shows details of the percentages of direct or indirect ownership of subsidiaries by the Company at 31 December 2018, 2017 and 2016, as well as the consolidation method used in each case for preparation of the accompanying consolidated Financial statements.

Subsidiaries in which the Company directly or indirectly owns the majority of equity or voting rights have been fully consolidated. Associates in which the Company owns between 20% and 50% of share capital and over which it has no control but does have significant influence, have been accounted for under the equity method.

Although the Group holds 30% of the shares with voting rights of Grifols Malaysia Sdn Bhd, it controls the majority of the economic and voting rights of Grifols Malaysia Sdn Bhd through a contract with the other shareholder and a pledge on its shares. As a consequence it has been fully consolidated.

F-13

Table of Contents

GRIFOLS, S.A. AND SUBSIDIARIES

Notes to the Consolidated Financial statements

Grifols (Thailand) Ltd. has two classes of shares and it grants the majority of voting rights to the class of shares held by the Group. As a consequence it has been fully consolidated.

Changes in associates and jointly controlled entities are detailed in note 10.

Changes in subsidiaries

In 2018:

· On 28 December 2018, Grifols sold Biotest US Corporation and Haema AG to Scranton Enterprises B.V. for a global amount of US Dollars 538,014 thousand. Scranton is an existing shareholder of Grifols (see note 3(b)).

· On 1 August 2018, Grifols, through its subsidiary Grifols Shared Services North America, Inc. has completed the acquisition of 100% of the shares in Biotest US Corporation for a price of US Dollars 286,454 thousand, after obtaining the consent of the US Federal Trade Commission (see note 3).

· On 19 March 2018, Grifols entered into an agreement with Aton GmbH for the purchase of 100% of the shares of German based pharmaceutical company Haema AG, in exchange for a purchase price of Euros 220,191 thousand on a debt free basis. The closing of this transaction took place in June 2018 (see note 3).

· On 26 January 2018, Grifols through its subsidiary Grifols Shared Services North America, Inc, suscribed a capital increase in the amount of US Dollars 98 million in the U.S company Goetech LLC, based in Denver, Colorado, trading as Medkeeper. As a result, Grifols holds a 54.76% interest in Medkeeper. Grifols and a majority position on the board of directors.

· On 12 January 2018 the Group acquired the remaining 50% of the voting rights of Aigües Minerals de Vilajuïga, S.A. and consequently Grifols holds 100% of the voting rights for a total amount of Euros 550 thousand.

In 2017:

· On 4 December 2017, Progenika Biopharma, S.A., transferred the total shares of Abyntek Biopharma, S.L. to a third party. No profit or loss was recognized on this transaction.

· On 11 October 2017, Grifols Diagnostic Solutions, Inc. acquired an additional 0.98% interest in Progenika Biopharma, S.A. from its non-controlling interests for a total amount of Euros 644 thousand in the form of a cash payment. As a result, Grifols owed 90.23% of Progenika’s share capital at 31 December 2017.

· On 24 July 2017, Grifols acquired an additional 40% interest in Kiro Grifols, S.L. for a purchase price of Euros 12.8 million. With this new acquisition, Grifols reached a 90% interest in equity of Kiro Grifols S.L. (see note 3(b)).

· On 13 March 2017, Progenika Latina, S.A. de C.V., was wound up. The assets and liabilities of Progenika Latina. S.A. de C.V were integrated into Progenika Biopharma, S.A.

· On 31 January 2017, Grifols closed the transaction for the asset purchase agreement to acquire Hologic’s business of NAT (Nucleic Acid Testing) donor screening unit, previously agreed on 14 December 2016, for a total amount of US Dollars 1,865 million (see note 3(a)).

· On 5 January 2017, the Group incorporated a new company called Chiquito Acquisition Corp.

· With effect as of 1 January 2017, Grifols Diagnostic Solutions, Inc. and Progenika, Inc. entered into a merger agreement. The surviving company was Grifols Diagnostic Solutions, Inc.

F-14

Table of Contents

GRIFOLS, S.A. AND SUBSIDIARIES

Notes to the Consolidated Financial statements

In 2016 Grifols incorporated the following companies:

· PBS Acquisition Corp. (USA)

· Grifols Diagnostics Equipment Taiwan Limited (Taiwan)

· Grifols Innovation and New Technologies Limited (Ireland)

· On 12 December 2016, the Group company Grifols Innovation and New Technologies Limited subscribed to an increase in the share capital of VCN Biosciences, S.L. amounting to Euros 5 million. Following this capital increase, Grifols’ interest rose to 81.34% in 2016. Grifols subscribed to another capital increase on 16 November 2015 through the Group company Gri-Cel, S.A. for an amount of Euros 2,549 thousand (see note 3 (d)).

· With effect as of 1 November 2016, Grifols Brasil, Lda. and Gri-Cei, S.A. Produtos para Trasfusao entered into a merger agreement. The surviving company was Grifols Brasil, Lda.

· In August 2016 and July 2015 Araclon Biotech, S.L. carried out two share capital increases of Euros 6.7 million and Euros 6 million, respectively. After the latter capital increase Grifols’ interest rose to 73.22% (see note 15 (c)).

· In July 2016 the Group acquired an additional 20% of the assets of Medion Diagnostics AG. in exchange for 59,951 treasury stocks (Class B Shares) from its non-controlling interests. After this acquisition, Grifols’ interest rose to 100%.

· On 3 March, 2016 the Group executed the call option on 32.93% of the shares in Progenika Biopharma, S.A. for Euros 25 million following the exercise of call and put options agreed in February 2013. Grifols paid 50% of this investment in Grifols B shares (876,777 shares) and the remaining 50% in cash. The Group guaranteed the selling shareholders the option to repurchase the Class B shares during the first five days following the sale date. As a result of this transaction, Grifols owns 89.25% of Progenika Biopharma, S.A.’s share capital at 31 December 2016.

· With effect as of 1 January 2016, Progenika Biopharma, S.A. and Brainco Biopharma, S.L. entered into a merger agreement. The surviving company was Progenika Biopharma, S.A.

(c) Amendments to IFRS in 2018, 2017 and 2016

In accordance with IFRS, the following should be noted in connection with the scope of application of IFRS and the preparation of these consolidated Financial statements of the Group.

Effective date in 2016

|  |  |  | Mandatory application for annual periods beginning on or after:
Standards |  |  |  | IASB effective date |  | EU effective date
IAS 16 IAS 38 |  | Clarification of Acceptable Methods of Depreciation and Amortisation (issued on 12 May 2014) |  | 1 January 2016 |  | 1 January 2016
IFRS 11 |  | Accounting for Acquisitions of Interests in Joint Operations (issued on 6 May 2014) |  | 1 January 2016 |  | 1 January 2016
IAS 27 |  | Equity Method in Separate Financial Statements (issued on 12 August 2014) |  | 1 January 2016 |  | 1 January 2016
Various |  | Annual Improvements to IFRSs 2012-2014 cycle (issued on 25 September 2014) |  | 1 January 2016 |  | 1 January 2016
IAS 1 |  | Disclosure Initiative (issued on 18 December 2014) |  | 1 January 2016 |  | 1 January 2016

F-15

Table of Contents

GRIFOLS, S.A. AND SUBSIDIARIES

Notes to the Consolidated Financial statements

Effective date in 2017

|  |  |  | Mandatory application for annual periods beginning on or after:
Standards |  |  |  | IASB effective date |  | EU effective date
IAS 12 |  | Recognition of Deferred Tax Assets for Unrealized Losses (issued on 19 January 2016) |  | 1 January 2017 |  | 1 January 2017
IAS 7 |  | Disclosure Initiative (issued on 29 January 2016) |  | 1 January 2017 |  | 1 January 2017
Various |  | Annual improvements to IFRSs 2014 - 2016 cycle (issued on 8 December 2016) - IFRS 12 |  | 1 January 2017 |  | 1 January 2017

Effective date in 2018

|  |  |  | Mandatory application for annual periods beginning on or after:
Standards |  |  |  | IASB effective date |  | EU effective date
IFRS 15 |  | Revenue from contracts with Customers (issued on 28 May 2014) |  | 1 January 2018 |  | 1 January 2018
IFRS 15 |  | Clarification to IFRS15 Revenue from Contracts with Customers (issued on 12 April 2016) |  | 1 January 2018 |  | 1 January 2018
IFRS 9 |  | Financial instruments (issued on 24 July 2014) |  | 1 January 2018 |  | 1 January 2018
IFRS 2 |  | Classification and Measurement of Share-based Payment Transactions (issued on 20 June 2016) |  | 1 January 2018 |  | 1 January 2018
IFRS 4 IFRS 9 |  | Applying IFRS 9 Financial Instruments with IFRS 4 Insurance Contracts (issued on 12 September 2016) |  | 1 January 2018 |  | 1 January 2018
IFRIC 22 |  | IFRIC 22 Interpretation: Foreign currency translations and Advance Consideration (issued on 8 December 2016) |  | 1 January 2018 |  | 1 January 2018
IAS 40 |  | Amendments to IAS 40: Transfers of Investment Property (issued on 8 December 2016) |  | 1 January 2018 |  | 1 January 2018
Various |  | Annual improvements to IFRSs 2014 - 2016 cycle (issued on 8 December 2016) |  | 1 January 2018 |  | 1 January 2018

The application of these standards and interpretations has had some impacts on these consolidated Financial statements, which are detailed below:

IFRS 9 Financial Instruments

IFRS 9 Financial Instruments was applied on 1 January, 2018 without any restatements of the comparative figures relative for the prior year. The impacts of the first-time adoption, recognized directly in equity, are as follows:

· Classification and measurement of financial assets:

In general terms, based on the analysis of the new classification based on the business model, the majority of financial assets have continued to be measured at amortized cost, the main exception being equity instruments, which are measured at fair value through profit or loss.

· Impairment of financial assets:

For trade receivables the Group uses the simplified approach, estimating lifetime expected credit losses, while for all other financial assets the Group has used the general approach for calculating expected credit losses. In both cases, due to the customers’ credit rating, as well as the internal classification systems currently in place for new customers, and considering that collection periods are mostly under 30 days, the adoption of IFRS 9 does not have a significant impact.

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Notes to the Consolidated Financial statements

· Modification or exchanges of financial liabilities that do not result in derecognition of liabilities

According to the IASB’s interpretation published in October 2017, when a financial liability measured at amortized cost is modified or exchanged and does not result in the derecognition of the financial liability, a gain or loss should be recognized in profit or loss, calculated as the difference between the original contractual cash flows from the liability and the new modified cash flows, discounted at the original effective interest rate of the liability.

IFRS 9 must be applied retrospectively as of 1 January 2018, therefore any gains or losses from the modification of financial liabilities that arise from applying the new standard in years prior to 1 January 2018 have been recognized in reserves at that date and the comparative period has not been re-expressed. Grifols has retrospectively calculated the impact of adopting IFRS 9 on the refinancing of its senior debt and unsecured senior corporate notes in 2014 and 2017. As a result of these new calculations, the 2014 refinancing of both debts did not cause the derecognition of the respective liabilities, therefore generating an adjustment to profit and loss in that year. Considering the retroactive adjustment generated in 2014, the 2017 refinancing of senior debt did not result in the derecognition of the financial liability either. However, the refinancing of the unsecured senior corporate notes led to derecognition of the liability as it did not pass the new quantitative test. The adoption of IFRS 9 has entailed a positive impact on reserves of Euros 24,636 thousand.

Details of the impacts on reserves due to the application of IFRS 9 application are as follows:

|  | Thousand of Euros |
|  |  |  |  |  | Impact |
Senior Unsecured Noted |  | IAS 39 |  | IFRS 9 |  | 01/01/2018 |
Total Debt |  | 853,667 |  | 1,000,000 |  | 146,333 |
Deferred Expenses |  |  |  |  |  | (41,035 | )
Negative Impact in reserves |  |  |  |  |  | 105,298 |

|  | Thousand of Euros |
|  |  |  |  |  | Impact |
Senior Secured Debt |  | IAS 39 |  | IFRS 9 |  | 01/01/2018 |
Total Debt |  | 3,375,157 |  | 3,226,244 |  | (148,913 | )
Deferred Expenses |  |  |  |  |  | 18,979 |
Positive impact in reserves |  |  |  |  |  | (129,934 | )

|  | Thousand of Euros |
|  |  |  |  |  | Impact |
Total Impact |  | IAS 39 |  | IFRS 9 |  | 01/01/2018 |
Total Debt |  | 4,228,824 |  | 4,226,244 |  | (2,580 | )
Deferred Expenses |  |  |  |  |  | (22,056 | )
Positive impact in reserves |  |  |  |  |  | (24,636 | )

IFRS 15 Revenue from Contracts with Customers.

IFRS 15 provides a framework that replaces the previous guides on revenue recognition. According to the new criteria, a five-step model should be used to determine the timing and amounts of revenue recognition:

Step 1: Identify the contract.

Step 2: Identify the performance obligations in the contract.

Step 3: Determine the transaction price.

Step 4: Allocate the transaction price to the performance obligations in the contract.

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Notes to the Consolidated Financial statements

Step 5: Recognize revenue.

This new model specifies that revenue should be recognized when (or as) control of the goods or services is transferred from an entity to customers, for the amount the entity expects to be entitled to receive. Depending on whether certain criteria are met, revenue is recognized over time, reflecting that the entity has satisfied the performance obligation, or at a point in time, when control of the goods or services is transferred to customers.

Based on the analysis and implementation at 1 January 2018, there has been no impact from adopting IFRS 15 Revenue from Contracts with Customers.

Standards issued but not effective in 2018

|  |  |  | Mandatory application for annual periods
|  |  |  | beginning on or after:
Standards |  |  |  | IASB effective date |  | EU effective date
IFRS 16 |  | Leases (Issued on 13 January 2016) |  | 1 January 2019 |  | 1 January 2019
IFRIC 23 |  | Uncertainty over Income Tax Treatments (issued on 7 June 2017) |  | 1 January 2019 |  | 1 January 2019
IFRS 9 |  | Amendment to IFRS 9: Prepayment Features with Negative Compensation (issued on 12 October 2017) |  | 1 January 2019 |  | 1 January 2019
IAS 28 |  | Amendment to IAS 28: Long-term interests in Associates and Joint Ventures (issued on 12 October 2017) |  | 1 January 2019 |  | pending
Various |  | Annual Improvements to IFRS Standards 2015-2017 Cycle (issued on 12 December 2017) |  | 1 January 2019 |  | pending
IFRS 17 |  | Insurance Contracts (issued on 18 May 2017) |  | 1 January 2021 |  | pending
IAS 19 |  | Amendment to IAS19: Plan Amendment, Curtailment or Settlemet (issued on 7 February 2018) |  | 1 January 2019 |  | pending
IFRS 3 |  | Amendment to IFRS 3: Definition of a business (issued on 22 October 2018) |  | 1 January 2020 |  | pending
IAS 1 IAS 8 |  | Amendments to IAS 1 and IAS 8: Definition of material (issued on 31 October 2018) |  | 1 January 2020 |  | pending
IFRS 1 |  | Amendments to the Conceptual Framework for Financial Reporting (issued on 29 March 2018) |  | 1 January 2020 |  | pending

The application of these standards and interpretations, except for IFRS 16 “Leases”, is not expected to have any significant impacts on the consolidated Financial statements.

IFRS 16 “Leases”

IFRS 16 brings in a single model for lease accounting by lessees in the statement of financial position. A lessee recognises a right-of-use asset representing its right to use the underlying asset and a lease liability representing its obligation to make lease payments. There are optional exemptions for short-term leases and leases of low value items. Lessor accounting remains similar to the current standard. Lessors continue to classify leases as finance or operating leases.

IFRS 16 replaces existing guidance on leases, including IAS 17 Leases, IFRIC 4 Determining whether an arrangement contains a lease, SIC-15 Operating leases-Incentives and SIC-27 Evaluating the substance of transactions involving the legal form of a lease.

IFRS 16 is mandatory for all financial years starting on or after 1 January 2019. It may be adopted in advance by companies that already use IFRS 15 Revenue from contracts with customers prior to the date of first-time application of IFRS 16. The Group will first-time adopt IFRS 16 on 1 January 2019 and is in the process of estimating the impact on the consolidated Financial statements. The main policies, estimates and criteria for the application of IFRS 16 are as follows:

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Notes to the Consolidated Financial statements

· Scope: this IFRS 16 evaluation considers all the contracts in which the Group acts as lessee, except for the contracts between Group companies and the cancelable contracts.

· Transition approach: The Group has opted to implement IFRS 16 using the modified retrospective approach, whereby the right-of-use asset is measured at an amount equal to the lease liability, adjusted by the amount of any prepaid or accrued lease payments relating to that lease recognized in the consolidated statement of financial position immediately before the date of initial application. When applying this modified retrospective approach, the Group does not re-express the comparative information.

· Discount rates: For financial lease contracts, Grifols will discount lease payments using the implicit interest rate. For operating lease agreements, lease payments will be discounted using the incremental borrowing rate. The incremental borrowing rate is the rate of interest that a lessee would have to pay to borrow over a similar term, and with a similar security, the funds necessary to obtain an asset of a similar value to the right-of-use asset in a similar economic environment.

An incremental effective interest rate has been applied and varies from 2.07% to 8.18% depending on the geographical area and the term of the lease agreement at the date of initial application.

· Lease term for each agreement: The term considered for the leases depends, fundamentally, on whether or not the lease contract contains a period of mandatory compliance, as well as unilateral termination and or renewal clauses that grant the Group the right to terminate early or to extend the agreements.

The Group leases several buildings, equipment and vehicles. Leases agreements are usually made for fixed periods, as shown below:

|  | Average lease term
Real Estate and land |  | 10 to 15 years
Donor centers |  | 13 to 15 years
PC’s and hardware |  | 3 to 5 years
Machinery |  | 4 to 5 years
Vehicles |  | 3 to 5 years

The lease terms of the agreements are negotiated on an individual basis and contain a wide range of terms and conditions.

· Accounting policies applied during transition: The Group has employed the following practical solutions when applying the simplified method to leases previously carried as operating leases under IAS 17 Leases:

· Non-application of IFRS 16 to agreements that were not previously deemed to contain a lease under IAS 17 and IFRIC 4 “Determining whether an arrangement contains a lease”.

· Exclusion of the initial direct costs from the measurement of the right-of-use asset on the date of first-time adoption.

· Exclusion of leases that expire within 12 months as from the date of first-time adoption.

· Exclusion of leases in which the underlying asset has a low value.

· Estimated effect of adoption: At 1 January 2019, the Group has non-cancellable operating lease commitments of Euros 400,579 thousand for buildings and warehouses (see note 28). Of these commitments, approximately Euros 4,822 thousand of these commitments relate to short-term leases which will be recognized on a straight-line basis as expense in profit and loss. For the remaining lease commitments, the Group expects to recognise right-of-use assets of approximately Euros 648,345 thousand at 1 January, 2019 (after adjustments for prepayments, dismantling costs and accrued lease payments recognized as at 31 December 2018 by an amount of approximately Euros 16,898 thousand) and lease liabilities of Euros 664,948 thousand.

· Total net assets will be approximately Euros 16,603 thousand lower, and net current assets will be Euros 43,318 thousand lower due to, mainly, the presentation of a portion of the liability as a current liability.

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Notes to the Consolidated Financial statements

The Group expects net profit before tax to fall by approximately Euros 15,500 thousand in 2019 due to the adoption of the new Standard for the lease agreements for buildings and warehouses. EBITDA is expected to increase by approximately Euros 60,281 thousand, as the operating lease payments were included in EBITDA but the amortisation charges on right-of-use assets and interest on the lease liability are excluded from this measurement.

Operating cash flows will increase and cash flows from financing will decrease by approximately Euros 60,281 thousand, since the repayment of principal on the lease liabilities and interest will be classified as cash flows from financing activities.

In addition, Grifols has performed the reconciliation of lease liabilities for buildings and warehouses in relation to leases which had previously been classified as operating leases under IAS 17 (related to non-cancelable agreements and renewals) and lease liabilities under IFRS 16:

|  | 01/01/2019 |
|  | Thousands of Euros |
Operating lease commitments existing as at 31 December 2018 |  | 400,579 |
Periods covered by an option to extend the lease by the Group |  | 579,261 |
Discounting using the Group’s incremental borrowing rate |  | (311,116 | )
finance lease liabilities recognised as at 31 December 2018 |  | 1,395 |
Short-term leases recognised on a straight-line basis as expense |  | (4,822 | )
Others |  | (349 | )
Lease liability recognised as at 1 January 2019 |  | 664,948 |

The Group’s activities as a lessor are immaterial, and therefore the Group does not expect any significant impact on the consolidated Financial statements.

(3) Business Combinations

2018

(a) Acquisition of assets used in donor centers from Kedplasma

In August and December of 2018, Grifols through its company Biomat USA, Inc. acquired the assets used in the operation of six donor centers from Kedplasma LLC. The purchase price agreed was Euros 20,939 thousand and Euros 21,841 thousand, respectively. These amounts have been provisionally allocated to goodwill in the consolidated balance sheet, considering that the initial accounting has not been completed at the end of the reporting period.

(b) Biotest Acquisition

On 1 August 2018, Grifols, through its subsidiary Grifols Shared Services North America, Inc. completed the acquisition of 100% of the shares in Biotest US Corporation for a price of US Dollars 286,454 thousand, after obtaining the consent of the US Federal Trade Commission. Grifols has acquired the shares from Biotest Divestiture Trust.

Biotest USA owns a plasma collection business in the USA with 24 plasma collection centers throughout the territory. In the preceding financial year, it obtained approximately 850,000 liters of plasma.

Details of the aggregate business combination cost, the fair value of the net assets acquired and goodwill at the acquisition date are provided below:

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Notes to the Consolidated Financial statements

|  | Thousands of Euros |  | Thousands of US Dollars |
Total business combination cost |  | 245,126 |  | 286,454 |
Fair value of net assets acquired |  | 114,463 |  | 133,761 |
Goodwill (excess of the cost of the business combination over the fair value of net assets acquired) |  | 130,663 |  | 152,693 |

The amounts determined at the date of acquisition of assets, liabilities and contingent liabilities were as follows:

|  | Fair value |
|  | Thousands of Euros |  | Thousands of US Dollars |
Cash and cash equivalents |  | 5,876 |  | 6,867 |
Trade and other receivables |  | 15,114 |  | 17,663 |
Inventories |  | 18,235 |  | 21,309 |
Other assets |  | 2,438 |  | 2,849 |
Intangible assets (note 8) |  | 19,511 |  | 22,800 |
Goodwill |  | 5,571 |  | 6,510 |
Property, Plant and equipment (note 9) |  | 22,190 |  | 25,931 |
Deferred tax assets |  | 33,917 |  | 39,635 |
Financial assets |  | 10,975 |  | 12,825 |
Total assets |  | 133,827 |  | 156,389 |
Trade and other payables |  | (5,322 | ) | (6,219 | )
Other liabilities |  | (4,249 | ) | (4,965 | )
Deferred tax liability |  | (4,878 | ) | (5,700 | )
Long-term liabilities |  | (4,915 | ) | (5,744 | )
Total liabilities and contingent liabilities |  | (19,364 | ) | (22,628 | )
Total net assets acquired |  | 114,463 |  | 133,761 |
Goodwill (note 7) |  | 130,663 |  | 152,693 |
Total business combination cost |  | 245,126 |  | 286,454 |

The resulting goodwill has been allocated to the Bioscience segment.

If the acquisition had taken place on 1 January 2018, the net amount of the Group´s revenue and profit would have increased by Euros 90,216 thousand and Euros 5,592 thousand, respectively.

The revenue and profit of Biotest between the acquisition date and 31 December 2018 amounted to Euros 73,747 thousand and Euros 7,473 thousand, respectively.

On 28 December 2018, Grifols sold Biotest US Corporation and Haema AG to Scranton Enterprises B.V. for the global amount of US Dollars 538,014 thousand (see note 1), Scranton is an existing shareholder of Grifols (see note 31). The current sale of Biotest and Haema to Scranton took place for the same price, at the current US Dollar/Euro exchange rate, and under the same terms and conditions existing when Grifols acquired both companies.

The sale of Biotest and Haema has not resulted in a loss of control for the Group. In assessing the existence of control, Grifols has considered the potential voting rights to determine whether it has power and therefore

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Notes to the Consolidated Financial statements

control. The Group holds potential voting rights arising from the repurchase options of the shares and they are substantive, based on the following:

· The sale contract includes a call option for Grifols which grants the irrevocable and exclusive right (not an obligation) to be able to acquire the shares sold to Scranton (both at the same time) at any time from the effective date of sale.

· The purchase option has been negotiated jointly in the same sale agreement of the entities.

· The price of exercising the call option will be equal to the higher of: a) the price at which Grifols sold them plus costs incurred in the transaction and plus the increase in working capital and (b) the amount of the debt that Scranton owns the date on which Grifols exercises the option (principal plus interest plus any other cost to be able to cancel said loan). Considering that the projections for the entities are for growth and an improvement in their results is expected, it is concluded that said call option is “in the money” since their market price is estimated to be higher than that agreed in the call option.

· Even if a nullity clause on the call option is included in the case of default by the buyer (standard clause included in financing agreements), it has been considered remote since Grifols will have the capacity to exercise said call option in the remediation period of 90 days.

· There are no agreements between shareholders that establish that the relevant decisions are approved in a different manner than by majority vote.

· There is a commitment from Grifols to provide support services in the plasma collection business of the donation centers for their subsequent sale and thus ensure that these companies will continue to operate effectively, as well as ensuring the continuity and growth of said entities. Likewise, there is a “Plasma Supply Agreement” agreement whereby the plasma to be produced by these entities will be almost entirely to meet the needs of Grifols. There is no exclusivity of sale.

The aforementioned are indicators of Grifols’ power over these entities, even after their sale, considering that the repurchase options are susceptible to being exercised and Grifols would have the financial capacity to carry them out.

Consequently, the sale of the entities does not result in a loss of control, which is why the entities continue to consolidate, recording the sale as a transaction in equity without any impact on the consolidated statements of profit and loss.

(c) Haema AG

On 19 March 2018, Grifols has entered into an agreement with Aton GmbH for the purchase of 100% of the shares of the German based pharmaceutical company Haema AG, in exchange for a purchase price of Euros 220,191 thousand on a debt free basis. This transaction was closed in June 2018.

With this acquisition, and subject to the conditions being met, Grifols will acquire Haema’s business, based on the collection of plasma for fractionation, which includes 35 plasma collection centers located throughout Germany, and three more centers under construction. Haema’s headquarters are located in Leipzig measuring approximately 24,000 m² (which include administration, production, storage and power station buildings) and also has a central laboratory in Berlin.

Haema employs about 1,100 people and collected almost 800,000 liters of plasma in the preceding financial year, coming from approximately 1 million donations.

Details of the aggregate business combination cost, the fair value of the net assets acquired and goodwill at the acquisition date are provided below:

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Notes to the Consolidated Financial statements

|  | Thousands of Euros |
Total business combination cost |  | 220,191 |
Fair value of net assets acquired |  | 49,057 |
Goodwill (excess of the cost of the business combination over the fair value of net assets acquired) |  | 171,134 |

The amounts determined at the date of acquisition of assets, liabilities and contingent liabilities were as follows:

|  | Fair value |
|  | Thousands of Euros |
Cash and cash equivalents |  | 7,727 |
Trade and other receivables |  | 10,321 |
Inventories |  | 5,535 |
Other assets |  | 836 |
Intangible assets (note 8) |  | 1,518 |
Property, Plant and equipment (note 9) |  | 25,407 |
Total assets |  | 51,344 |
Trade and other payables |  | (1,795 | )
Contingent liabilities |  | (492 | )
Total liabilities and contingent liabilities |  | (2,287 | )
Total net assets acquired |  | 49,057 |
Goodwill (note 7) |  | 171,134 |
Total business combination cost |  | 220,191 |

The resulting goodwill has been allocated to the Bioscience segment.

If the acquisition had taken place on 1 January, 2018, the net amount of the Group´s revenue would have increased by Euros 39,517 thousand and the Group´s profit would not have deferred significantly.

The revenue and profit of Haema AG between the acquisition date and 31 December 2018 amounted to Euros 46,758 thousand and Euros 53 thousand, respectively.

On 28 December 2018, Grifols sold Haema AG to Scranton Enterprises B.V (see note 3 (b) for more details).

(d) Goetech, LLC Acquisition (“MedKeeper”)

On 26 January 2018, Grifols through its subsidiary Grifols Shared Services North America, Inc, suscribed a capital increase for an amount of US Dollars 98 million in the U.S company Goetech LLC, with headquarters in Denver, Colorado, and trading as Medkeeper. As a result of this transaction, Grifols held 51% interest in Medkeeper and also holds a majority position on the board of directors.

The acquisition agreement includes the repurchase of own shares by Medkeeper from the non-controlling shareholder in the amount of US Dollars 14 million (in 2 business days) and US Dollars 20 million (in two years). The agreement grants a call option to Grifols to acquire the remaining non-controlling stake for a term of three years and Medkeeper has a put option to sell this stake to Grifols, which may be executed at the end of the three-year period.

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Notes to the Consolidated Financial statements

As the non-controlling shareholders do not currently have access to the economic rewards associated with the underlying ownership interests related to shares under the put and call commitment, we have applied the advance-acquisition method. Under this method we recognize the agreement as an advance acquisition of the underlying non-controlling interest, as if the put option had already been exercised by the non-controlling shareholders.

Medkeeper´s core business is the development and distribution of web and mobile-based platforms for hospital pharmacies that improve quality standards, productivity in the processes, control systems and monitoring different preparations, while increasing patient safety.

This investment will enhance the activity of the Grifols Hospital Division and it is part of the strategy to underpin this division into the U.S. market.

Details of the aggregate business combination cost, the fair value of the net assets acquired and goodwill at the acquisition date are provided below:

|  | Thousands of Euros |  | Thousands of US Dollars |
Cost of the business combination |  |  |  |  |
First repurchase of non-controlling interests |  | 11,475 |  | 14,000 |
Second repurchase of non-controlling interests (discounted amount) |  | 14,952 |  | 18,241 |
Purchase of remaining non-controlling interests |  | 42,998 |  | 52,458 |
Total business combination cost |  | 69,425 |  | 84,699 |
Fair value of net assets acquired |  | 14,104 |  | 17,207 |
Goodwill (excess of the cost of the business combination over the fair value of net assets acquired) (note 7) |  | 55,321 |  | 67,492 |

The amounts determined at the date of acquisition of assets, liabilities and contingent liabilities were as follows:

|  | Fair value |
|  | Thousands of Euros |  | Thousands of US Dollars |
Intangible assets (note 8) |  | 30,561 |  | 37,285 |
Property, Plant and equipment (note 9) |  | 67 |  | 82 |
Other non-current assets |  | 2,350 |  | 2,867 |
Other current assets |  | 4,453 |  | 5,433 |
Total assets |  | 37,432 |  | 45,667 |
Non-current liabilities |  | (2,186 | ) | (2,667 | )
Current liabilities |  | (7,711 | ) | (9,407 | )
Deferred tax liability |  | (13,431 | ) | (16,386 | )
Total liabilities and contingent liabilities |  | (23,328 | ) | (28,460 | )
Total net assets acquired |  | 14,104 |  | 17,207 |

The resulting goodwill has been allocated to the Hospital segment.

If the acquisition had taken place on 1 January, 2018, the net amount of the Group´s revenue and profit would not have deferred significantly.

The revenue and profit of Goetech LLC between the acquisition date and 31 December 2018 amounted to Euros 9,210 thousand and Euros 1,778 thousand, respectively.

(e) Plasmavita Healthcare GmbH

In 2017, Grifols incorporated PLASMAVITA GmbH, a joint venture between Grifols (50%) and two European partners (50%). The company aims to set up at least 10 plasma centers in Germany. The share capital amounts to Euros 25,000, divided into 25,000 nominal shares of Euro 1 each, subscribed by both parties at Euros 12,500

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Notes to the Consolidated Financial statements

each. During 2018, Grifols contributes an amount of Euros 10,000 thousand, which can be increased by an additional Euros 10 million, which will be used to finance the project.

(f) Aigües Minerals de Vilajuïga, S.A.

On 1 June 2017 the Group announced the acquisition of 50% of the voting rights in Aigües Minerals de Vilajuïga, S.A. a company based in Vilajuïga, Girona, Spain.

On 12 January 2018 the Group acquired the remaining 50% of the voting rights and consequently Grifols holds 100% of the voting rights for a total amount of Euros 550 thousand.

Aigües Minerals de Vilajuïga, S.A.’s principal activity is the collection and use of mineral-medicinal waters and the procurement of all necessary administrative concessions in order to facilitate the extraction of these waters and find the best way to exploit them.

2017

(a) Hologic Acquisition

On 14 December 2016 Grifols entered into an asset purchase agreement to acquire assets corresponding to Hologic’s NAT (Nucleic Acid Testing) business donor screening unit for US Dollars 1,865 million. The transaction was closed on 31 January 2017. The agreement encompasses the acquisition of the Hologic business engaged in research, development and manufacture of assays and instruments based on NAT technology for transfusion and transplantation screening. In addition, it was agreed to cancel the existing joint-collaboration agreement for the commercialization of NAT donor screening products by Grifols. NAT technology makes it possible to detect the presence of infectious agents in blood and plasma donations, contributing to greater transfusion safety.

The transaction is structured through the purchase of assets by Grifols Diagnostic Solutions, Inc., a U.S. incorporated and wholly-owned subsidiary of Grifols, S.A.

The assets acquired comprise a plant in San Diego, California (United States) as well as development rights, licenses to patents and access to product manufacturers.

Grifols consolidates itself as one of the only vertically integrated providers capable of offering comprehensive solutions to blood and plasma donation centers.

This acquisition strengthens cash flows and positively impacts the Group’s margins. The sales revenues of the Diagnostic Division will not change as a result of the acquisition due to the existing commercialization agreement between Grifols and Hologic in place since 2014, under which Grifols commercializes this line of business.

It is expected that this acquisition will strengthen the position of the Grifols Diagnostic Division in transfusion medicine and will increase significantly the profitability of Grifols Diagnostic Division having a direct impact on the Group’s EBITDA margin. By streamlining and integrating the NAT business, operational efficiency will be in terms of production, R&D, overheads and administrative expenses.

Details of the aggregate business combination cost, the fair value of the net assets acquired and goodwill at the acquisition date are provided below:

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Notes to the Consolidated Financial statements

|  | Thousands of Euros |  | Thousands of US Dollars |
Cost of the business combination |  |  |  |  |
Payment in cash |  | 1,734,077 |  | 1,865,000 |
Result of the cancellation of the existing contract |  | 41,894 |  | 45,057 |
Total business combination cost |  | 1,775,971 |  | 1,910,057 |
Fair value of net assets acquired |  | 309,551 |  | 332,923 |
Goodwill (excess of the cost of the business combination over the fair value of net assets acquired) (see note 7) |  | 1,466,420 |  | 1,577,134 |

As part of the purchase price allocation, the Company determined that the identifiable intangible assets were developed technology and IPR&D. The fair value of the intangible assets was estimated using the income approach. The cash flows were based on estimates used to price the transaction and the discount rates applied were benchmarked with reference to the implied rate of return from the transaction model and the weighted average cost of capital.

The developed technology assets are comprised of know-how, patents and technologies embedded in revenue. The Company applied the Relief-from-Royalty Method to determine its fair value. IPR&D projects relate to in-progress projects that have not reached technological feasibility as of the acquisition date. All of the IPR&D assets were valued using the Multiple-Period Excess Earnings Method approach.

The excess of the purchase price over the estimated fair value of the net assets acquired was recorded as goodwill. The factors contributing to the recognition of the amount of goodwill were the acquired workforce, cost savings and benefits arising from the vertical integration of the business that will lead to efficiencies in R&D, commercial and manufacturing activities.

The expenses incurred in this transaction in 2017 amounted to approximately Euros 13 million (Euros 5.1 million in 2016).

The amounts determined at the date of acquisition of assets, liabilities and contingent liabilities were as follows:

|  | Fair Value |
|  |  |  | Thousands of US |
|  | Thousands of Euros |  | Dollars |
R&D in progress |  | 137,756 |  | 148,157 |
Other Intangible assets |  | 142,174 |  | 152,908 |
Property, plant and equipment |  | 24,569 |  | 26,424 |
Deferred Tax Assets (note 27) |  | 16,736 |  | 18,000 |
Inventories |  | 30,157 |  | 32,434 |
Total Assets |  | 351,392 |  | 377,923 |
Current Provisions (note 19 (b)) |  | 41,841 |  | 45,000 |
Total liabilities and contingent liabilities |  | 41,841 |  | 45,000 |
Total net assets acquired |  | 309,551 |  | 332,923 |

The resulting goodwill has been allocated to the Diagnostic segment.

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Notes to the Consolidated Financial statements

(b) Kiro Grifols, S.L.

On 25 July 2017 the Group acquired an additional 40% interest in Kiro Grifols, S.L for an amount of Euros 12.8 million. In September 2014 the Group subscribed a capital increase in Kiro Grifols, S.L for an amount of Euros 21 million, by virtue of which Grifols acquired 50% of Kiro Grifols, S.L.’s economic and voting rights.

As a result, Grifols owns a 90% interest in Kiro Grifols. S.L. The remaining 10% will continue to be held by Socios Fundadores Kiro, S.L. a company wholly owned by cooperatives of the Mondragon Corporation.

Grifols also entered into a joint venture & shareholders’ agreement (the “Joint Venture Agreement”) with Kiro Grifols’ partners: Mondragon Innovacion S.P.E, S.A.; Mondragon Assembly, S.Coop. and Agrupación de Fundición y Utillaje, S.Coop.. This agreement governs, among other matters, the capital increase subscribed by Grifols and the managing and governing bodies of Kiro Grifols, whether these are the Board of Directors or any other internal managing and governing bodies.

(c) Kedplasma

On 27 December 2016 Grifols entered into an agreement to acquire six new Plasma Donor Centers to the company Kedplasma, LLC, with a purchase price of US Dollars 47 million. These centers were handed over in February 2017.

Aggregate details of the combination cost, fair value of the net assets acquired and goodwill at the acquisition date are as follows:

|  | Thousands of Euros |  | Thousands of US Dollars |
Cost of the business combination |  |  |  |  |
Payment in cash |  | 44,238 |  | 47,083 |
Total business combination cost |  | 44,238 |  | 47,083 |
Fair value of net assets acquired |  | 4,137 |  | 4,403 |
Goodwill (excess of the cost of the business combination over the fair value of net assets acquired) (note 7) |  | 40,101 |  | 42,680 |

The fair value of net assets acquired includes property, plant and equipment amounting to Euros 3,698 thousand.

Goodwill is allocated to the Bioscience segment and includes the plasma donor data base, FDA licenses and workforce retained.

At 31 December 2016, the Group advanced the sum of US Dollars 15 million related to this acquisition.

2016

During 2016, no significant business combinations were made for the Group.

(4) Significant Accounting Policies

(a) Subsidiaries and associates

Subsidiaries are entities, including special purpose entities (SPE), over which the Group exercises control, either directly or indirectly, through subsidiaries. The Group controls a subsidiary when it has the substantive rights in force that provide the ability to manage relevant activities. The Group is exposed or has the right to variable returns for its involvement in the subsidiaries when the returns obtained vary depending on the economic performance of the subsidiaries.

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Notes to the Consolidated Financial statements

The income, expenses and cash flows of subsidiaries are included in the consolidated Financial statements from the date of acquisition, which is when the Group takes control. Subsidiaries are excluded from the consolidated Group from the date on which control is lost.

Transactions and balances with Group companies and unrealized gains or losses have been eliminated upon consolidation.

The accounting policies of subsidiaries have been adapted to those of the Group for transactions and other events in similar circumstances.

The Financial statements of consolidated subsidiaries have been prepared as of the same date and for the same reporting period as the Financial statements of the Company.

Associates are entities over which the Company, either directly or indirectly through subsidiaries, exercises significant influence. Significant influence is the power to participate in the financial and operating policy decisions of the investee but is not control or joint control over those entities. The existence of potential voting rights that are exercisable or convertible at the end of each reporting period, including potential voting rights held by the Group or other entities, are considered when assessing whether an entity has significant influence.

Investments in associates are initially recognized at acquisition cost, including any cost directly attributable to the acquisition and any consideration receivable or payable contingent on future events or on compliance with certain conditions.

Subsequently, investments in associates are accounted for using the equity method from the date that significant influence commences until the date that significant influence ceases.

The excess of the cost of the investment over the Group’s share of the fair values of the identifiable net assets is recognized as goodwill, which is included in the carrying amount of the investment. Any shortfall, once the cost of the investment and the identification and measurement of the associate’s net assets have been evaluated, is recognized as income when determining the investor’s share of the profit and loss of the associate for the year in which it was acquired.

The accounting policies of associates have been harmonized in terms of timing and measurement, applying the policies described for subsidiaries.

The Group’s share of the profit and loss of an associate from the date of acquisition is recognized as an increase or decrease in the value of the investments, with a credit or debit to share of the profit and loss for the year of “equity-accounted investees” in the consolidated statement of profit and loss (consolidated statement of comprehensive income). The Group’s share of other comprehensive income of associates from the date of acquisition is recognized as an increase or decrease in the investments in associates with a balancing entry recognized by type in other comprehensive income. The distribution of dividends is recognized as a decrease in the value of the investment. The Group’s share of profit and loss, including impairment losses recognized by the associates, is calculated based on income and expenses arising from application of the acquisition method.

When the Group’s share of the losses in an investment accounted for using the equity method equals or exceeds its interest in the entity, the Group does not recognize additional losses, unless it has incurred in obligations or made payments on behalf of the other entity.

The Group’s share of the profit and loss of an associate and changes in equity is calculated to the extent of the Group’s interest in the associate at year end and does not reflect the possible exercise or conversion of potential voting rights. However, the Group’s share is calculated taking into account the possible exercise of potential voting rights and other derivative financial instruments which, in substance, currently allow access to the economic benefits associated with the interests held, such as entitlement to a share in future dividends and changes in the value of associates.

Information on the subsidiaries and associates included in the consolidated Group is presented in Appendix I.

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Notes to the Consolidated Financial statements

(b) Business combinations

On the date of transition to IFRS-EU, 1 January 2004, the Group applied the exception permitted under IFRS 1 “First-time adoption of International Financial Reporting Standards”, whereby only those business combinations performed as from 1 January 2004 have been recognized using the acquisition method. Entities acquired prior to that date were recognized in accordance with accounting prevailing at that time, taking into account the necessary corrections and adjustments at the transition date.

The Group applies the revised IFRS 3 “Business combinations” in transactions made subsequent to 1 January 2010.

The Group applies the acquisition method for business combinations.

The acquisition date is the date on which the Group obtains control of the acquiree.

Business combinations made subsequent to 1 January 2010

The cost of the business combination is calculated as the sum of the acquisition-date fair values of the assets transferred, the liabilities incurred or assumed, equity instruments issued and any additional consideration contingent on future events or the fulfilment of certain conditions, in exchange for control of the acquiree.

The consideration paid excludes all amounts that do not form part of the exchange for the acquired business. Acquisition-related costs are accounted for as expenses when incurred. Share increase costs are recognized as equity when the increase takes place and borrowing costs are deducted from the financial liability when it is recognized.

At the acquisition date the Group recognizes at fair value the assets acquired and liabilities assumed. Liabilities assumed include any contingent liabilities that represent present obligations arising from past events for which the fair value can be reliably measured. The Group also recognizes indemnification assets transferred by the seller at the same time and following the same measurement criteria as the item that is subject to indemnification from the acquired business, taking into consideration, where applicable, the insolvency risk and any contractual limit on the indemnity amount.

This criterion does not include non-current assets or disposal groups of assets which are classified as held for sale, long-term defined benefit employee benefit liabilities, share-based payment transactions, deferred tax assets and liabilities and intangible assets arising from the acquisition of previously transferred rights.

Assumed assets and liabilities are classified and designated for subsequent measurement in accordance with the contractual terms, economic conditions, operating or accounting policies and other factors that exist at the acquisition date, except for leases and insurance contracts.

The excess between the consideration transferred and the value of net assets acquired and liabilities assumed, less the value assigned to non-controlling interests, is recognized as goodwill. Where applicable, any shortfall, after evaluating the consideration transferred, the value assigned to non-controlling interests and the identification and measurement of net assets acquired, is recognized in profit and loss.

When a business combination has been provisionally determined, net identifiable assets have initially been recognized at their provisional value, and any adjustments made during the measurement period have been recorded as if they had been known at that date. Where applicable, comparative figures for the prior year have been restated. Adjustments to the provisional values only reflect information relating to events and circumstances existing at the acquisition date and which, had they been known, would have affected the amounts recognized at that date. Once this period has elapsed, adjustments are only made to initial values when errors must be corrected. Any potential benefits arising from tax losses and other deferred tax assets of the acquiree that have not been recorded as they did not qualify for recognition at the acquisition date, are accounted for as income tax revenue, provided the adjustments were not made during the measurement period.

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Notes to the Consolidated Financial statements

The contingent consideration is classified in accordance with underlying contractual terms as a financial asset or financial liability, equity instrument or provision. Provided that subsequent changes to the fair value of a financial asset or financial liability do not relate to an adjustment of the measurement period, they are recognized in consolidated profit and loss. The contingent consideration classified, where applicable, as equity is not subject to subsequent change, with settlement being recognized in equity. The contingent consideration classified, where applicable, as a provision is recognized subsequently in accordance with the relevant measurement standard.

Business combinations made prior to 1 January 2010

The cost of the business combination is calculated as the sum of the acquisition-date fair values of the assets transferred, the liabilities incurred or assumed, and equity instruments issued by the Group, in exchange for control of the acquiree, plus any costs directly attributable to the business combination. Any additional consideration contingent on future events or the fulfilment of certain conditions is included in the cost of the combination provided that it is probable that an outflow of resources embodying economic benefits will be required and the amount of the obligation can be reliably estimated. Subsequent recognition of contingent considerations or subsequent variations to contingent considerations is recognized as a prospective adjustment to the cost of the business combination.

Where the cost of the business combination exceeds the Group’s interest in the fair value of the identifiable net assets of the entity acquired, the difference is recognized as goodwill, whilst the shortfall, once the costs of the business combination and the fair values of net assets acquired have been reconsidered, is recognized in profit and loss.

(c) Non-controlling interests

Non-controlling interests in subsidiaries acquired after 1 January 2004 are recognized at the acquisition date at the proportional part of the fair value of the identifiable net assets. Non-controlling interests in subsidiaries acquired prior to the transition date were recognized at the proportional part of the equity of the subsidiaries at the date of first consolidation.

Non-controlling interests are disclosed in the consolidated balance sheet under equity separately from equity attributable to the Parent. Non-controlling interests’ share in consolidated profit and loss for the year (and in consolidated comprehensive income for the year) is disclosed separately in the consolidated statement of profit and loss (consolidated statement of comprehensive income).

The consolidated profit and loss for the year, consolidated comprehensive income and changes in equity of the subsidiaries attributable to the Group and non-controlling interests after consolidation adjustments and eliminations, is determined in accordance with the percentage ownership at year end, without considering the possible exercise or conversion of potential voting rights. However, Group and non-controlling interests are calculated taking into account the possible exercise of potential voting rights and other derivative financial instruments which, in substance, currently allow access to the economic benefits associated with the interests held, such as entitlement to a share in future dividends and changes in the value of subsidiaries.

Profit and loss and each component of other comprehensive income are assigned to equity attributable to shareholders of the Parent and to non-controlling interests in proportion to their interest, although this implies a balance receivable from non-controlling interests. Agreements signed between the Group and the non-controlling interests are recognized as a separate transaction.

The increase and reduction of non-controlling interests in a subsidiary in which control is retained is recognized as an equity instrument transaction. Consequently, no new acquisition cost arises on increases, nor is a gain recorded on reductions; rather, the difference between the consideration transferred or received and the carrying amount of the non-controlling interests is recognized in the reserves of the investor, without prejudice to reclassifying consolidation reserves and reallocating other comprehensive income between the Group and the non-controlling interests. When a Group’s interest in a subsidiary diminishes, non-controlling interests are recognized at their share of the net consolidated assets, including goodwill.

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Notes to the Consolidated Financial statements

(d) Joint arrangements

Joint arrangements are those in which there is a contractual agreement to share the control over an economic activity, in such a way that the decisions over relevant activities require the unanimous consent of the Group and the remaining venturers. Under IFRS 11 “Joint arrangements” investments in joint arrangements are classified as joint operations or joint ventures. The classification depends on the contractual rights and obligations of each investor, rather than on the legal structure of the joint agreement.

Interests in joint ventures are accounted for using the equity method, after initially being recognized at cost in the consolidated balance sheet.

The acquisition cost of investments in joint arrangements is determined consistently with that established for investments in associates.

(e) Foreign currency transactions and balances

(i) Functional and presentation currency

The consolidated Financial statements are presented in thousands of Euros, which is the functional and presentation currency of the Parent.

(ii) Foreign currency transactions, balances and cash flows

Foreign currency transactions are translated into the functional currency using the previous month’s exchange rate for all transactions performed during the current month. This method does not differ significantly from applying the exchange rate at the date of the transaction.

Monetary assets and liabilities denominated in foreign currencies have been translated into thousands of Euros at the closing rate, while non-monetary assets and liabilities measured at historical cost have been translated at the exchange rate prevailing at the transaction date. Non-monetary assets measured at fair value have been translated into thousands of Euros at the exchange rate at the date that the fair value was determined.

In the consolidated statement of cash flows, cash flows from foreign currency transactions have been translated into thousands of Euros at the exchange rates prevailing at the dates the cash flows occur. The effect of exchange rate fluctuations on cash and cash equivalents denominated in foreign currencies is recognized separately in the statement of cash flows as “Effect of exchange rate fluctuations on cash and cash equivalents”.

Exchange gains and losses arising on the settlement of foreign currency transactions and the translation into thousands of Euros of monetary assets and liabilities denominated in foreign currencies are recognized in profit and loss.

(iii) Translation of foreign operations

The translation into thousands of Euros of foreign operations for which the functional currency is not the currency of a hyperinflationary economy is based on the following criteria:

· Assets and liabilities, including goodwill and net asset adjustments derived from the acquisition of the operations, including comparative amounts, are translated at the closing rate at the reporting date;

· Income and expenses, including comparative amounts, are translated using the previous month’s exchange rate for all transactions performed during the current month. This method does not differ significantly from using the exchange rate at the date of the transaction;

· Translation differences resulting from application of the above criteria are recognized in other comprehensive income.

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Notes to the Consolidated Financial statements

(f) Borrowing costs

In accordance with IAS 23 “Borrowing Costs”, since 1 January 2009 the Group recognizes borrowing costs directly attributable to the purchase, construction or production of qualifying assets as an increase in the value of these assets. Qualifying assets are those which require a substantial period of time before they can be used or sold. To the extent that funds are borrowed specifically for the purpose of obtaining a qualifying asset, the amount of borrowing costs eligible for capitalization is determined as the actual borrowing costs incurred, less any investment income on the temporary investment of those funds. Capitalized borrowing costs corresponding to general borrowing are calculated as the weighted average of the qualifying assets without considering specific funds. The amount of borrowing costs capitalized cannot exceed the amount of borrowing costs incurred during that period. The capitalized borrowing costs include adjustments to the carrying amount of financial liabilities arising from the effective portion of hedges entered into by the Group.

The Group begins capitalizing borrowing costs as part of the cost of a qualifying asset when it incurs expenditure for the asset, interest is accrued, and it undertakes activities that are necessary to prepare the asset for its intended use or sale, and ceases capitalizing borrowing costs when all or substantially all the activities necessary to prepare the qualifying asset for its intended use or sale are complete. Nevertheless, capitalization of borrowing costs is suspended when active development is interrupted for extended periods.

The remaining interest costs are recognized as an expense in the year in which they are incurred.

(g) Property, plant and equipment

(i) Initial recognition

Property, plant and equipment are recognized at cost or deemed cost, less accumulated depreciation and any accumulated impairment losses. Land is not subject to depreciation. The cost of self-constructed assets is determined using the same principles as for an acquired asset, while also considering the criteria applicable to production costs of inventories. Capitalized production costs are recognized by allocating the costs attributable to the asset to “Self-constructed non-current assets” in the consolidated statement of profit and loss.

(ii) Depreciation

Property, plant and equipment are depreciated by allocating the depreciable amount of an asset on a systematic basis over its useful life. The depreciable amount is the cost or deemed cost of an asset, less its residual value. The Group determines the depreciation charge separately for each item for a component of property, plant and equipment with a cost that is significant in relation to the total cost of the asset.

Property, plant and equipment are depreciated using the following criteria:

|  | Depreciation method |  | Rates
Buildings |  | Straight line |  | 1% - 3%
Other property, technical equipment and machinery |  | Straight line |  | 4%-10%
Other property, plant and equipment |  | Straight line |  | 7% - 33%

The Group reviews residual values, useful lives and depreciation methods at each financial year end. Changes to initially established criteria are accounted for as a change in accounting estimates.

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Notes to the Consolidated Financial statements

(iii) Subsequent recognition

Subsequent to initial recognition of the asset, only those costs incurred which will probably generate future profits and for which the amount may reliably be measured are capitalized. Costs of day-to-day servicing are recognized in profit and loss as incurred.

Replacements of property, plant and equipment which qualify for capitalization are recognized as a reduction in the carrying amount of the items replaced. Where the cost of the replaced items has not been depreciated independently and it is not possible to determine the respective carrying amount, the replacement cost is used as indicative of the cost of items at the time of acquisition or construction.

(iv) Impairment

The Group tests for impairment and reversals of impairment losses on property, plant and equipment based on the criteria set out in note 4(i) below.

(h) Intangible assets

(i) Goodwill

Goodwill is generated on the business combinations and is calculated using the criteria described in the section on business combinations.

Goodwill is not amortized, but is tested for impairment annually or more frequently whenever there is an indication that goodwill may be impaired. Goodwill acquired in business combinations is allocated to the cash-generating units (CGUs) or groups of CGUs which are expected to benefit from the synergies of the business combination and the criteria described in note 7 are applied. After initial recognition, goodwill is measured at cost less any accumulated impairment losses. Gains and losses on the sale of an entity include the carrying amount of the goodwill related to the entity sold.

(ii) Internally generated intangible assets

Any research and development expenditure incurred during the research phase of projects is recognized as an expense when incurred.

Costs related with development activities are capitalized when:

· The Group has technical studies that demonstrate the feasibility of the production process;

· The Group has undertaken a commitment to complete production of the asset, to make it available for sale or internal use;

· The asset will generate sufficient future economic benefits;

· The Group has sufficient technical and financial resources to complete development of the asset and has devised budget control and cost accounting systems that enable monitoring of budgetary costs, modifications and the expenditure actually attributable to the different projects.

The cost of internally generated assets by the Group is calculated using the same criteria established for determining production costs of inventories. The production cost is capitalized by allocating the costs attributable to the asset to self-constructed non-current assets in the consolidated statement of profit and loss.

Expenditure on activities that contribute to increasing the value of the different businesses in which the Group as a whole operates is expensed when incurred. Replacements or subsequent costs incurred on intangible assets are generally recognized as an expense, except where they increase the future economic benefits expected to be generated by the assets.

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Notes to the Consolidated Financial statements

Development costs previously recognized as an expense are not recognized as an asset in a subsequent period.

(iii) Other intangible assets

Other intangible assets are carried at cost, or at fair value if they arise on business combinations, less accumulated amortization and impairment losses.

Intangible assets with indefinite useful lives are not amortized but tested for impairment at least annually.

(iv) Intangible assets acquired in business combinations

The cost of the identifiable intangible assets acquired in Biotest’s business combination includes the fair value of the current contracts.

The cost of identifiable intangible assets acquired in the business combination of Hologic includes the fair value of the R&D projects and the Intellectual Property-Patents.

The cost of identifiable intangible assets acquired in the business combination of Novartis includes the fair value of the existing royalty agreements.

The cost of identifiable intangible assets acquired in the Progenika business combination includes the fair value of currently marketed products sold and which are classified under “Other intangible assets”and “Research and Development”.

The cost of identifiable intangible assets acquired in the Talecris business combination includes the fair value of currently marketed products sold and which are classified under “Other intangible assets”.

(v) Useful life and amortization rates

The Group assesses whether the useful life of each intangible asset acquired is finite or indefinite. An intangible asset is regarded as having an indefinite useful life when there is no foreseeable limit to the period over which the asset will generate net cash inflows.

Intangible assets with finite useful lives are amortized by allocating the depreciable amount of an asset on a systematic basis over its useful life, by applying the following criteria:

|  | Amortisation method |  | Rates
Development expenses |  | Straight line |  | 10%
Concessions, patents, licences, trademarks and similar |  | Straight line |  | 4% - 20%
Computer software |  | Straight line |  | 33%
Currently marketed products |  | Straight line |  | 3% - 10%

The depreciable amount is the cost or deemed cost of an asset, less its residual value.

The Group does not consider the residual value of its intangible assets to be material. The Group reviews the residual value, useful life and amortization method for intangible assets at each financial year end. Changes to initially established criteria are accounted for as a change in accounting estimates.

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Notes to the Consolidated Financial statements

(i) Impairment of goodwill, other intangible assets and other non-financial assets subject to depreciation or amortization

The Group evaluates whether there are indications of possible impairment losses on non-financial assets subject to amortization or depreciation, to verify whether the carrying amount of these assets exceeds the recoverable amount.

The Group tests goodwill, intangible assets with indefinite useful lives and intangible assets with finite useful lives that are not available for use for potential impairment at least annually, irrespective of whether there is any indication that the assets may be impaired.

The recoverable amount of the assets is the higher of their fair value less costs of disposal and their value in use. An asset’s value in use is calculated based on an estimate of the future cash flows expected to derive from the use of the asset, expectations about possible variations in the amount or timing of those future cash flows, the time value of money, the price for bearing the uncertainty inherent in the asset and other factors that market participants would reflect in pricing the future cash flows deriving from the asset.

Negative differences arising from comparison of the carrying amounts of the assets with their recoverable amounts are recognized in the consolidated statement of profit and loss. Recoverable amount is determined for each individual asset, unless the asset does not generate cash inflows that are largely independent of those from other assets or groups of assets. If this is the case, recoverable amount is determined for the cash-generating unit (CGU) to which the asset belongs.

Impairment losses recognized for cash-generating units are first allocated to reduce, where applicable, the carrying amount of goodwill allocated to the CGU and then to the other assets of the CGU pro rata on the basis of the carrying amount of each asset. The carrying amount of each asset may not be reduced below the highest of its fair value less costs of disposal, its value in use and zero.

At the end of each reporting period the Group assesses whether there is any indication that an impairment loss recognized in prior periods may no longer exist or may have decreased. Impairment losses on goodwill are not reversible. Impairment losses on other assets are only reversed if there has been a change in the estimates used to calculate the recoverable amount of the asset.

A reversal of an impairment loss is recognized in consolidated profit and loss. The increased carrying amount of an asset attributable to a reversal of an impairment loss may not exceed the carrying amount that would have been determined, net of depreciation or amortization, had no impairment loss been recognized.

A reversal of an impairment loss for a CGU is allocated to the assets of each unit, except goodwill, pro rata with the carrying amounts of those assets. The carrying amount of an asset may not be increased above the lower of its recoverable amount and the carrying amount that would have been disclosed, net of amortization or depreciation, had no impairment loss been recognized.

(j) Leases

(i) Lessee accounting records

The Group has rights to use certain assets through lease contracts.

Leases in which the Group assumes substantially all the risks and rewards incidental to ownership are classified as finance leases, otherwise they are classified as operating leases.

· Finance leases

At the commencement of the lease term, the Group recognizes finance leases as assets and liabilities at the lower of the fair value of the leased asset and the present value of the minimum lease payments. Initial direct costs are added to the asset’s carrying amount. Minimum lease payments are apportioned between the finance charge and the reduction of the outstanding liability. The finance charge is allocated to each period during the lease term so as to produce a constant periodic rate of interest on the remaining balance of the liability. Contingent rents are recognized as an expense in the years in which they are incurred. Property, plant and equipment acquired through a finance lease is amortized over the useful life of the asset or within the term of the lease, whichever is less, if there

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Notes to the Consolidated Financial statements

is no reasonable certainty that the group will obtain the property at the end of the term of the lease.

· Operating leases

Lease payments under an operating lease (excluding incentives) are recognized as an expense on a straight-line basis unless another systematic basis is representative of the time pattern of the user’s benefit.

(ii) Leasehold investments

Non-current investments in properties leased from third parties are recognized on the basis of the same criteria for property, plant and equipment. Investments are amortized over the lower of their useful lives and the term of the lease contract. The lease term is consistent with that established for recognition of the lease.

(iii) Sale and leaseback transactions

Any profit on sale and leaseback transactions that meet the conditions of a finance lease is deferred over the term of the lease.

When the leaseback is classified as an operating lease:

· If the transaction is established at fair value, any profit and loss on the sale is recognized immediately in the consolidated statement of profit and loss for the year;

· If the sale price is below fair value, any profit and loss is recognized immediately in the consolidated statement of profit and loss. However, if the loss is compensated for by future lease payments at below market price, it is deferred in proportion to the lease payments over the period for which the asset is to be used.

(k) Financial instruments

(i) Classification of the financial instruments

Financial instruments are classified at the time of their initial recognition as a financial asset, a financial liability or an equity instrument, in accordance with the economic substance of the contractual agreement and with the definitions of financial assets, financial liabilities or equity instruments indicated in IAS 32 “Financial instruments: Presentation”.

For purposes of its valuation, the Group classifies financial instruments in the categories of financial assets and financial liabilities at fair value through profit or loss, separating those initially designated from those held for trading or mandatorily measured at fair value through profit or loss, financial assets and financial liabilities valued at amortized cost and financial assets measured at fair value through other comprehensive income, separating the equity instruments designated as such, from other financial assets. The classification depends on the Group’s business model to manage the financial assets and the contractual terms of the cash flows.

The Group classifies a financial asset at amortized cost if it is held in the framework of a business model whose objective is to hold financial assets to obtain contractual cash flows and the contractual terms of the financial asset give rise, on specified dates, to cash flows which are only principal and interest payments on the outstanding principal amount (OPIP).

The Group classifies a financial asset at fair value through changes in other comprehensive income, if it is maintained in the framework of a business model whose objective is achieved by obtaining contractual cash flows and selling financial assets and the contractual conditions of the financial asset give rise to, at specified dates, to cash flows that are OPIP.

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Notes to the Consolidated Financial statements

The business model is determined by the key personnel of the Group and at a level that reflects the way in which they jointly manage groups of financial assets to achieve a specific business objective. The Group’s business model represents the way in which it manages its financial assets to generate cash flows.

Financial assets that are part of a business model whose objective is to hold assets to receive contractual cash flows are managed to generate cash flows in the form of contractual collections during the life of the instrument. The Group manages the assets held in the portfolio to receive these specific contractual cash flows. To determine whether cash flows are obtained through the collection of contractual cash flows from financial assets, the Group considers the frequency, value and timing of sales in prior years, the reasons for those sales and expectations in relation to with the future sales activity. However, the sales themselves do not determine the business model and, therefore, cannot be considered in isolation. Instead, it is the information on past sales and future sales expectations that provides indicative data on how to achieve the stated objective of the Group with respect to the management of financial assets and, more specifically, the way where cash flows are obtained.

For assets measured at fair value, losses and gains will be recognized in profit or loss or other comprehensive income. For investments in equity instruments that are not held for trading, it will depend on whether the Group has made an irrevocable election at the time of initial recognition to account for investments in equity at fair value through other comprehensive income (COCI).

The Group reclassifies investments in debt when and only when its business model to manage those assets changes.

(ii) Measurement

At the time of initial recognition, the Group values a financial asset at its fair value plus, in the case of a financial asset that is not at fair value through profit or loss, the costs of the transaction that are directly attributable to the acquisition. The transaction costs of financial assets at fair value through profit or loss are taken to results.

In order to determine the fair value of financial assets or liabilities, the Group uses market data as much as possible. Based on the factors used for the measurement, the fair values are hierarchized based on the following levels:

· Level 1: quoted prices (unadjusted) within current markets for assets or liabilities identical to those under consideration.

· Level 2: factors other than the prices considered in Level 1 that come directly from the asset or liability in question, such as those that may derive directly from the price.

· Level 3: factors not based on data directly from the market.

In the event that the factors used to determine the fair value of an asset or liability are included in different levels of hierarchy, the fair value will be determined in its entirety based on the significant component located at the lowest level of hierarchy.

(iii) Offseting principles

A financial asset and a financial liability are offset only when the Group has the legally enforceable right to set off the recognized amounts and intends either to settle on a net basis, or to realize the asset and settle the liability simultaneously.

(iv) Financial assets and liabilities at fair value through profit or loss

Financial assets or liabilities at fair value through profit or loss are those that are classified as held for trading or have been designated from the moment of initial recognition.

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Notes to the Consolidated Financial statements

A financial asset or liability is classified as held for trading if:

· It is acquired or incurred mainly for the purpose of selling it or repurchasing it in the near term.

· On initial recognition it is part of a portfolio of identified financial instruments that are managed together and for which there is evidence of a recent pattern of short-term profit-taking, or

· It is a derivative, except for a derivative that is a financial guarantee contract or a designated and effective hedging instrument.

Financial assets and liabilities at fair value through profit or loss are initially recognized at fair value. Transaction costs directly attributable to the purchase or issue are recognized as an expense as incurred.

After initial recognition, they are recognized at fair value through profit or loss. The fair value is not reduced by the transaction costs that may be incurred by their eventual sale or disposal by other means.

The Group does not reclassify any financial asset or liability to or from this category as long as it is recognized in the consolidated statement of financial position.

(v) Financial assets at amortized cost

Financial assets at amortized cost are initially recognized at their fair value, including the transaction costs incurred, and are subsequently valued at amortized cost, using the effective interest rate method.

(vi) Debt instruments

The subsequent valuation of the debt instruments depends on the Group’s business model to manage the asset and the characteristics of the cash flows of the asset. The Group’s debt instruments consist mainly of trade and other receivables, which the Group classifies as financial assets at amortized cost.

Financial assets at amortized cost are assets that the Group holds for the collection of contractual cash flows when these cash flows represent only payments of principal and interest, and are valued at amortized cost. Interest income from these financial assets is included in finance income in accordance with the effective interest rate method.

(vii) Equity instruments

The Group holds financial assets owned, mainly equity instruments, which are measured at fair value. When Group management has chosen to present the gains and losses on the fair value of the equity investments in other comprehensive income, after the initial recognition, the equity instruments are measured at fair value, recognizing the loss or gain in other comprehensive income. The amounts recognized in other comprehensive income are not subject to reclassification to profit or loss, without prejudice to reclassification to reserves at the time when the instruments are derecognized. Dividends from such investments continue to be recognized in income for the year as other income when the Group’s right to receive payments is established.

(viii) Impairment

As of 1 January, 2018, the Group evaluates, on a prospective basis, the expected credit losses associated with its debt instruments recorded at amortized cost. The Group uses the practical solutions permitted by IFRS 9 to assess the expected credit losses related to commercial accounts using a simplified approach, eliminating the need to evaluate when there has been a significant increase in credit risk. The simplified approach requires that the expected losses be recorded from the initial recognition of receivables, so that the Group determines expected credit losses as a probability-weighted estimate of such losses over the expected life of the financial instrument.

The practical solution applied is the use of a provision matrix based on the segmentation into groups of homogeneous assets, applying the historical information of percentages of non-payment for said groups and applying reasonable information about the future economic conditions.

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Notes to the Consolidated Financial statements

The percentage of non-payment is calculated according to the current experience of non-payment during the last year, as it is a very dynamic market and is adjusted for the differences between current and historical economic conditions and considering projected information, which is reasonably available.

(ix) Derecognition of financial assets

The Group applies the criteria for the derecognition of financial assets to a part of a financial asset or to a part of a group of similar financial assets or to a financial asset or a group of similar financial assets.

Financial assets are derecognised when the rights to receive cash flows related to them have expired or have been transferred and the Group has substantially transferred the risks and rewards derived from their ownership.

(x) Financial liabilities at amortized cost

Financial liabilities, including trade payables and other accounts payable, that are not classified at fair value through profit or loss, are initially recognized at their fair value, less, if applicable, the transaction costs that are directly attributable to the issue. Subsequent to the initial recognition, liabilities classified under this category are valued at amortized cost using the effective interest rate method.

(xi) Derecognition and modification of financial liabilities

The Group derecognises a financial liability or part thereof when it has complied with the obligation contained in the liability, or is legally exempt from the main liability contained in the liability, either by virtue of a judicial process or by the creditor.

The Group considers that the conditions are substantially different if the present value of the discounted cash flows under the new conditions, including any commission paid net of any commission received, and using the original effective interest rate to make the discount, differs at least at 10 percent of the discounted present value of the cash flows that still remain of the original financial liability.

If the exchange is recorded as a cancellation of the original financial liability, the costs or commissions are recognized in consolidated results forming part of the result of the same. Otherwise, the costs or commissions adjust the carrying amount of the liability and are amortized by the amortized cost method during the remaining life of the modified liability.

The Group recognizes the difference between the carrying amount of the financial liability or a part of it that is canceled or assigned to a third party and the consideration paid, including any assigned asset different from the cash or liability assumed in profit or loss.

(l) Equity instruments

The Group’s acquisition of equity instruments of the Parent is recognized separately at cost of acquisition in the consolidated balance sheet as a reduction in equity, regardless of the motive of the purchase. Any gains or losses on transactions with treasury equity instruments are not recognized in consolidated profit and loss.

The subsequent redemption of Parent shares, where applicable, leads to a reduction in share capital in an amount equivalent to the par value of such shares. Any positive or negative difference between the cost of acquisition and the par value of the shares is debited or credited to reserves. Transaction costs related with treasury equity instruments, including issue costs related to a business combination, are accounted for as a reduction in equity, net of any tax effect.

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Notes to the Consolidated Financial statements

(m) Inventories

Inventories are measured at the lower of cost and net realizable value. The cost of inventories comprises all costs of purchase, costs of conversion and other costs incurred in bringing the inventories to their present location and condition.

The costs of conversion of inventories include costs directly related to the units of production and a systematic allocation of fixed and variable production overheads that are incurred in converting materials into finished goods. The allocation of fixed indirect overheads is based on the higher of normal production capacity or actual production.

The raw material used to produce haemoderivatives is human plasma, which is obtained from our donation centers using the plasmapheresis method. The cost of inventories includes the amount paid to plasma donors, or the amount billed by the seller when purchased from third parties, as well as the cost of products and devices used in the collection process, rental expenses and storage. This plasma has to be stored before use, which is an essential part of the production process. During the storage period, the plasma undergoes various virological tests and should be kept in quarantine in accordance with FDA and European Medicines Agency regulations, in order to guarantee that all the plasma is suitable for use in the production process.

To the extent that plasma storage costs are necessary to the production process, they are included as cost of inventories.

Indirect costs such as general management and administration costs are recognized as expenses in the period in which they are incurred.

The cost of raw materials and other supplies and the cost of merchandise are allocated to each inventory unit on a weighted average cost basis.

The transformation cost is allocated to each inventory unit on a FIFO (first-in, first-out) basis.

The Group uses the same cost model for all inventories of the same nature and with a similar use.

Volume discounts extended by suppliers are recognized as a reduction in the cost of inventories when it is probable that the conditions for discounts to be received will be met. Discounts for prompt payment are recognized as a reduction in the cost of the inventories acquired.

When the cost of inventories exceeds net realizable value, materials are written down to net realizable value, which is understood to be:

· For raw materials and other supplies, replacement cost. Nevertheless, raw materials and other supplies are not written down below cost if the finished goods into which they will be incorporated are expected to be sold at or above cost of production;

· Merchandise and finished goods, estimated selling price less costs to sell;

· Work in progress, the estimated selling price of related finished goods, less the estimated costs of completion and the estimated costs necessary to make the sale.

The previously recognized write-down is reversed against profit and loss when the circumstances that previously caused inventories to be written down no longer exist or when there is clear evidence of an increase in net realizable value because of changed economic circumstances. The reversal of the write-down is limited to the lower of the cost and revised net realizable value of the inventories. Write-downs may be reversed with a credit to “Cost of Sales”.

(n) Cash and cash equivalents

Cash and cash equivalents include cash on hand and demand deposits in financial institutions. They also include other short-term, highly liquid investments that are readily convertible to known amounts of cash and

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Notes to the Consolidated Financial statements

which are subject to an insignificant risk of changes in value. An investment normally qualifies as a cash equivalent when it has a maturity of less than three months from the date of acquisition.

The Group classifies cash flows relating to interest received and paid as operating activities, and dividends received and distributed are classified under investing and financing activities, respectively.

(o) Government grants

Government grants are recognized when there is reasonable assurance that they will be received and that the Group will comply with the conditions attached.

(i) Capital grants

Outright capital grants are initially recognized as deferred income in the consolidated balance sheet. Income from capital grants is recognized in the consolidated statement of profit and loss in line with the depreciation of the corresponding financed assets.

(ii) Operating grants

Operating grants received to offset expenses or losses already incurred, or to provide immediate financial support not related to future disbursements, are recognized in the consolidated statement of profit and loss.

(iii) Interest rate grants

Financial liabilities comprising implicit assistance in the form of below-market interest rates are initially recognized at fair value. The difference between this value, adjusted where necessary for the issue costs of the financial liability and the amount received, is recognized as a government grant based on the nature of the grant awarded.

(p) Employee benefits

(i) Defined contribution plans

The Group recognizes the contributions payable to a defined contribution plan in exchange for a service in the period in which contributions are accrued. Accrued contributions are recognized as an employee benefit expense in the corresponding consolidated statement of profit and loss in the year that the contribution was made.

(ii) Termination benefits

Termination benefits are recognized at the earlier of the date when the Group can no longer withdraw the offer of those benefits and when the Group recognizes costs for a restructuring that involves the payment of termination benefits.

For termination benefits payable as a result of an employee’s decision to accept an offer of benefits, the time when the Group can no longer withdraw the offer of termination benefits is the earlier of when the employee accepts the offer and when a restriction on the Group’s ability to withdraw the offer takes effect.

For termination benefits payable as a result of the Group’s decision to make an employee redundant, the Group can no longer withdraw the offer when it has informed the affected employees or union representatives of the plan and the actions required to complete the plan indicate that it is unlikely that significant changes to the plan will be made. The plan must identify the number of employees to be made redundant, their job classifications or functions and their locations and the expected completion date. The plan must also establish the termination benefits that employees will receive in sufficient detail that employees can determine the type and amount of benefits they will receive when their employment is terminated.

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Notes to the Consolidated Financial statements

If the Group expects to settle the termination benefits in full more than twelve months after year end, the liability is discounted using the market yield on high quality corporate bonds.

(iii) Short-term employee benefits

The Group recognizes the expected cost of short-term employee benefits in the form of accumulating compensated absences when the employees render service that increases their entitlement to future compensated absences. In the case of non-accumulating compensated absences, the expense is recognized when the absences occur.

The Group recognizes the expected cost of profit-sharing and bonus plans when it has a present legal or constructive obligation to make such payments as a result of past events and a reliable estimate of the obligation can be made.

(iv) Restricted Share Unit Retention Plan (RSU)

The Group gives share-based payments to certain employees who render services to the Company. The fair value of the services received is determined based on the estimated fair value of the shares given at the grant date. Because the equity instruments granted do not vest until the employees complete a specified period of service, those services are accounted for during the vesting period in the income statement as an expense for the year, with the corresponding increase in equity. The amount recognized corresponds to that settled once the agreed terms have been met and it will not be adjusted or revalued during the accrual period, as the commitment is settled in the form of shares.

The total amount recognized is calculated based on the incentive payable in shares, increasing in line with percentages agreed by the Group. If an employee decides to leave his/her job prior to the end of the accrual period, he/she will only receive the agreed incentive in the form of shares and the Company will be able to choose whether to settle in cash or using equity instruments.

(q) Provisions

Provisions are recognized when the Group has a present obligation (legal or implicit) as a result of a past event; it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation; and a reliable estimate can be made of the amount of the obligation. No provisions are recognized for future operating losses.

The amount recognized as a provision is the best estimate of the expenditure required to settle the present obligation at the end of the reporting period, taking into account all risks and uncertainties surrounding the amount to be recognized as a provision and, where the time value of money is material, the financial effect of discounting provided that the expenditure to be made each period can be reliably estimated. The discount rate used to determine the present value is a pre-tax rate that reflects the evaluations that the current market is making of the time value of money and the specific risks of the obligation. The increase in the provision due to the passage of time is recognized as an interest expense.

If it is not probable that an outflow of resources embodying economic benefits will be required to settle the obligation, the provision is reversed against the consolidated statement of profit and loss item where the corresponding expense was recognized.

(r) Revenue recognition

Revenue from the sale of goods or services is recognized at an amount that reflects the consideration that the Group expects to be entitled to receive in exchange for transferring goods or services to a customer, at the time when the customer obtains control of the goods or services rendered. The consideration that is committed in a contract with a client can include fixed amounts, variable amounts, or both. The amount of the consideration may vary due to discounts, reimbursements, incentives, performance bonuses, penalties or other similar items. Contingent consideration is included in the transaction price when it is highly probable that the amount of

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Notes to the Consolidated Financial statements

revenue recognized is not subject to future significant reversals. Revenue is presented net of the value added tax and any other amount or tax, which in substance corresponds to amounts received on behalf of third parties.

(i) Sale of goods

Revenue from the sale of goods is recognized when the Group meets the performance obligation by transferring the assets committed to the customer. An asset is transferred when the customer obtains control of that asset. When evaluating the satisfaction of the performance obligation, the Group considers the following indicators of the transfer of control, which include, but are not limited to the following:

· The Group has a present right to payment for the asset

· The customer has the legal right to the asset

· The Group has transferred the physical possession of the asset

· The customer has the significant risks and rewards of ownership of the asset

· The customer has accepted the asset

The Group participates in the government-managed Medicaid programs in the United States, accounting for Medicaid rebates by recognizing an accrual at the time a sale is recorded for an amount equal to the estimated claims for Medicaid rebates attributable to the sale. Medicaid rebates are estimated based on historical experience, legal interpretations of the applicable laws relating to the Medicaid program and any new information regarding changes in the program regulations and guidelines that would affect rebate amounts. Outstanding Medicaid claims, Medicaid payments and inventory levels are analyzed for each distribution channel and the accrual is adjusted periodically to reflect actual experience. While rebate payments are generally made in the following or subsequent quarter, any adjustments for actual experience have not been material.

As is common practice in the sector, the purchase contracts signed by some customers with the Group entitle these customers to price discounts for a minimum purchase volume, volume discounts or prompt payment discounts. The Group recognizes these discounts as a reduction in sales and receivables in the same month that the corresponding sales are invoiced based on the customer’s actual purchase figures or on past experience when the customer’s actual purchases will not be known until a later date.

In the USA, the Group enters into agreements with certain customers to establish contract pricing for the products, which these entities purchase from the authorized wholesaler or distributor (collectively, wholesalers) of their choice. Consequently, when the products are purchased from wholesalers by these entities at the contract price which is less than the price charged by the Group to the wholesaler, the Group provides the wholesaler with a credit referred to as a chargeback. The Group records the chargeback accrual at the time of the sale. The allowance for chargebacks is based on Group’s estimate of the wholesaler inventory levels, and the expected sell-through of the products by the wholesalers at the contract price based on historical chargeback experience and other factors. The Group periodically monitors the factors that influence the provision for chargebacks, and makes adjustments when it considers that actual chargebacks may differ from established allowances. These adjustments occur in a relatively short period of time. As these chargebacks are typically settled within 30 to 45 days of the sale, adjustments for actual experience have not been material.

(ii) Services rendered

Revenues associated with the rendering of service transactions are recognized by reference to the stage of completion at the consolidated balance sheet date when the outcome of the transaction can be estimated reliably. The outcome of a transaction can be estimated reliably when revenues, the stage of completion, the costs incurred and the costs to complete the transaction can be estimated reliably and it is probable that the economic benefits derived from the transaction will flow to the Group.

When the outcome of the transaction involving the rendering of services cannot be estimated reliably, revenue is recognized only to the extent of costs incurred that are recoverable.

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Notes to the Consolidated Financial statements

(iii) Interest income

Until June 2012 the Group has been recognizing interest receivable from the different Social Security affiliated bodies in Spain, to which it provides goods or services, on an accrual basis, and only for those bodies to which historically claims have been made and from which interest has been collected. As a result of the terms imposed by the Spanish Government in 2012 regarding the waiver of late payment interest on overdue receivables, the Group modified its estimate regarding late payment interest. Since June 2012 the Group has only been recognizing late payment interest on receivables from Social Security affiliated bodies on the date on which delayed invoices are collected, as it is highly likely that they will be collected as of that date provided.

(s) Income taxes

The income tax expense or tax income for the year comprises current tax and deferred tax.

Current tax is the amount of income taxes payable or recoverable in respect of the consolidated taxable profit or consolidated tax loss for the year. Current tax assets or liabilities are measured at the amount expected to be paid to or recovered from the taxation authorities, using the tax rates and tax laws that have been enacted or substantially enacted at the reporting date.

Deferred tax liabilities are the amounts of income taxes payable in future periods in respect of taxable temporary differences, whereas deferred tax assets are the amounts of income taxes recoverable in future periods in respect of deductible temporary differences, the carryforward of unused tax losses, and the carryforward of unused tax credits. Temporary differences are differences between the carrying amount of an asset or liability in the balance sheet and its tax base.

Current and deferred tax are recognized as income or an expense and included in profit and loss for the year, except to the extent that the tax arises from a transaction or event which is recognized, in the same or a different year, directly in equity, or from a business combination.

(i) Taxable temporary differences

Taxable temporary differences are recognized in all cases except where:

· They arise from the initial recognition of goodwill or an asset or liability in a transaction that is not a business combination and, at the time of the transaction, affects neither accounting profit nor taxable income;

· They are associated with investments in subsidiaries over which the Group is able to control the timing of the reversal of the temporary difference and it is not probable that the temporary difference will reverse in the foreseeable future.

(ii) Deductible temporary differences

Deductible temporary differences are recognized provided that:

· It is probable that sufficient taxable income will be available against which the deductible temporary difference can be utilized, unless the differences arise from the initial recognition of an asset or liability in a transaction that is not a business combination and, at the time of the transaction, affects neither accounting profit nor taxable income;

· The temporary differences are associated with investments in subsidiaries to the extent that the difference will reverse in the foreseeable future and sufficient taxable income is expected to be generated against which the temporary difference can be offset.

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Notes to the Consolidated Financial statements

Tax planning opportunities are only considered when assessing the recoverability of deferred tax assets and if the Group intends to use these opportunities or it is probable that they will be utilized.

(iii) Measurement

Deferred tax assets and liabilities are measured at the tax rates that are expected to apply to the years when the asset is realized or the liability is settled, based on tax rates and tax laws that have been enacted or substantively enacted. The tax consequences that would follow from the manner in which the Group expects to recover or settle the carrying amount of its assets or liabilities are also reflected in the measurement of deferred tax assets and liabilities.

At year end the Group reviews the fair value of deferred tax assets to write down the balance if it is not probable that sufficient taxable income will be available to apply the tax asset.

Deferred tax assets which do not meet the above conditions are not recognized in the consolidated balance sheet. At year end the Group assesses whether deferred tax assets which were previously not recognized now meet the conditions for recognition.

(iv) Offset and classification

The Group only offsets current tax assets and current tax liabilities if it has a legally enforceable right to set off the recognized amounts and intends either to settle on a net basis, or to realize the asset and settle the liability simultaneously.

The Group only offsets deferred tax assets and liabilities where it has a legally enforceable right, where these relate to income taxes levied by the same taxation authority and where the taxation authority permits the entity to settle on a net basis, or to realize the asset and settle the liability simultaneously for each of the future years in which significant amounts of deferred tax assets or liabilities are expected to be settled or recovered.

Deferred tax assets and liabilities are recognized in the consolidated balance sheet under non-current assets or liabilities, irrespective of the expected date of recovery or settlement.

(t) Segment reporting

An operating segment is a component of the Group that engages in business activities from which it may earn revenues and incur expenses, whose operating results are regularly reviewed by the Group’s chief operating decision maker to make decisions about resources to be allocated to the segment, assess its performance and, based on which, differentiated financial information is available.

(u) Classification of assets and liabilities as current and non-current

The Group classifies assets and liabilities in the consolidated balance sheet as current and non-current. Current assets and liabilities are determined as follows:

· Assets are classified as current when they are expected to be realized or are intended for sale or consumption in the Group’s normal operating cycle, they are held primarily for the purpose of trading, they are expected to be realized within twelve months after the reporting date or are cash or a cash equivalent, unless the assets may not be exchanged or used to settle a liability for at least twelve months after the reporting date.

· Liabilities are classified as current when they are expected to be settled in the Group’s normal operating cycle, they are held primarily for the purpose of trading, they are due to be settled within twelve months after the reporting date or the Group does not have an unconditional right to defer settlement of the liability for at least twelve months after the reporting date.

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Notes to the Consolidated Financial statements

· Financial liabilities are classified as current when they are due to be settled within twelve months after the reporting date, even if the original term was for a period longer than twelve months, and an agreement to refinance, or to reschedule payments, on a long-term basis is completed after the reporting date and before the consolidated Financial statements are authorized for issue.

(v) Environmental issues

The Group takes measures to prevent, reduce or repair the damage caused to the environment by its activities.

Property, plant and equipment acquired by the Group for long-term use to minimize the environmental impact of its activity and protect and improve the environment, including the reduction and elimination of future pollution from the Group’s operations, are recognized as assets applying the measurement, presentation and disclosure criteria described in note 4(g).

(5) Financial Risk Management Policy

(a) General

The Group is exposed to the following risks associated with the use of financial instruments:

· Credit risk

· Liquidity risk

· Market risk: includes interest rate risk, currency risk and other price risks.

This note provides information on the Group’s exposure to each of these risks, the Group’s objectives and procedures to measure and mitigate this risk, and the Group’s capital management strategy. More exhaustive quantitative information is disclosed in note 30 to the consolidated Financial statements.

The Group’s risk management policies are established to identify and analyse the risks faced by the Group, define appropriate risk limits and controls and to control risks and comply with limits. Risk management policies and procedures are reviewed regularly so that they reflect changes in market conditions and the Group’s activities. The Group’s management procedures and rules are designed to create a strict and constructive control environment in which all employees understand their duties and obligations.

The Group’s Audit Committee supervises how management controls compliance with the Group’s risk management procedures and policies and reviews whether the risk management policy is suitable considering the risks to which the Group is exposed. This committee is assisted by Internal Audit which acts as supervisor. Internal Audit performs regular and ad hoc reviews of the risk management controls and procedures and reports its findings to the Audit Committee.

Credit risk

Credit risk is the risk to which the Group is exposed in the event that a customer or counterparty to a financial instrument fails to discharge a contractual obligation, and mainly results from trade receivables and the Group’s investments in financial assets.

Trade receivables

The Group does not predict any significant insolvency risks as a result of delays in receiving payment from some European countries due to their current economic situation. The main risk in these countries is that of late payments, which is mitigated through the possibility of claiming interest as foreseen by prevailing legislation. No significant bad debt or late payment issues have been detected for sales to private entities.

The Group recognizes impairment based on its best estimate of the expected losses on trade and other receivables. The main impairment losses recognized are due to specific losses relating to individually identified risks. At year end, these impairment losses are immaterial.

Details of exposure to credit risk are disclosed in note 30.

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Notes to the Consolidated Financial statements

Liquidity risk

Liquidity risk is the risk that the Group cannot meet its financial obligations as they fall due. The Group’s approach to managing liquidity is to ensure where possible, that it always has sufficient liquidity to settle its obligations at the maturity date, both in normal conditions and in times of tension, to avoid incurring unacceptable losses or tarnishing the Group’s reputation.

The Group manages liquidity risk on a prudent basis, based on availability of cash and sufficient committed unused long-term credit facilities, enabling the Group to implement its business plans and carry out operations using stable and secure sources of financing.

At 31 December 2018 the Group has total cash and cash equivalents of Euros 1,033,792 thousand (Euros 886,521 thousand at 31 December 2017). The Group also has approximately Euros 404,808 thousand in unused credit facilities (Euros 381,165 thousand at 31 December 2017), including Euros 262,008 thousand on the revolving credit facility (Euros 250,146 thousand at 31 December 2017).

The structure of the Group’s debt consists mainly of a non-current loan of US Dollars 5,992 million with institutional investors and banks divided into two tranches (Tranche A and Tranche B), in a US Dollars 300 million undrawn revolving credit facility and unsecured senior corporate notes for an amount of Euros 1,000 million.

As in previous years, the Group continues with its quarterly program for optimization of working capital, which is mainly based on contracts to sell receivables without recourse.

2018:

In September 2018 the Group received an additional non-current loan from the European Investment Bank totaling Euros 85,000 thousand. The loan will be used to support certain investments in R&D which are mainly focused on searching for new therapeutic for plasmatic proteins. Financial terms include a fixed interest rate for a period of 10 years with a grace period of two years. At 31 December 2018, the carrying amount of the loans obtained from the European Investment Bank is Euros 244,375 thousand (Euros 170,000 thousand at 31 December 2017).

2017:

On 5 December 2017 the Group received an additional loan from the European Investment Bank of up to Euros 85,000 thousand at a fixed interest rate for a period of 10 years with a grace period of 2 years. The loan will be used to support certain investments in R&D which are mainly focused on searching for new applications for plasmatic proteins. On 28 October 2015, the Group received its first loan from the same entity under the same terms, for a total amount of Euros 100,000 thousand.

On 18 April 2017 the Group concluded the refinancing process of the Senior Unsecured Notes. The total note issuance amounted to Euros 1,000 million.

On 6 February 2017 the Group concluded the refinancing process of its senior debt. The total debt refinanced amounts to US Dollars 6,300 million (Euros 5,800 million), including the US Dollars 1,816 million loan obtained for the acquisition of Hologic’s transfusional diagnostics unit. Following the refinancing process, Grifols’ debt structure consisted of a US Dollars 6,000 million long-term loan with institutional investors and banks segmented in two tranches (Term Loan A and Term Loan B), and a US Dollars 300 million undrawn revolving credit facility.

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Notes to the Consolidated Financial statements

Market risk

Market risk comprises the risk of changes in market prices, for example, exchange rates, interest rates, or the prices of equity instruments affecting the Group’s revenues or the value of financial instruments it holds. The objective of managing market risk is to manage and control the Group’s exposure to this risk within reasonable parameters at the same time as optimising returns.

(i) Currency risk

The Group operates internationally and is therefore exposed to currency risk when operating with foreign currencies, especially with regard to the US Dollar which is used in a significant percentage of transactions in foreign functional currencies. Currency risk is associated with future commercial transactions, recognized assets and liabilities, and net investments in foreign operations.

The Group holds significant investments in foreign operations, the net assets of which are exposed to currency risk. The conversion risk affecting net assets of the Group’s foreign operations in US Dollars is mitigated primarily through borrowings in this foreign currency.

The Group’s main exposure to currency risk is with regard to the US Dollar, which is used in a significant percentage of transactions in foreign functional currencies.

Details of the Group’s exposure to currency risk at 31 December 2018 and 2017 of the most significant financial instruments are shown in note 30.

(ii) Interest rate risk

The Group’s interest rate risks arise from current and non-current borrowings. Borrowings at variable interest rates expose the Group to cash flow interest rate risks. Fixed-rate borrowings expose the Group to fair value interest rate risk.

The objective of the management of interest rate risk is to achieve a balance in the structure of the debt, keeping part of the external resources issued at a fixed rate and covering part of the variable rate debt through hedges.

A significant part of the financing obtained accrues interest at fixed rates. This fixed interest debt (Senior Unsecured Notes) amounts to Euros 1,000 million, which represents approximately 54% of the Group’s total debt in Euros. The additional loans of Euros 244,375 thousand received from the European Investment Bank represent approximately 13% of the Group’s total debt in Euros.

Senior debt in Euros represents approximately 12% of the Group’s total Senior debt at 31 December 2018 and 31 December 2017.

Total fixed-interest debt represents 19% of total debt at 31 December 2018 (19% at 31 December 2017).

(iii) Market price risk

Price risk affecting raw materials is mitigated by the vertical integration of the haemoderivatives business in a highly-concentrated sector.

(b) Capital management

The directors’ policy is to maintain a solid capital base in order to ensure investor, creditor and market confidence and sustain future business development. The board of directors defines and proposes the level of dividends paid to shareholders.

The directors consider various arguments to calculate capital structure:

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Notes to the Consolidated Financial statements

· The directors control capital performance using rates of returns on equity (ROE). At 31 December 2018 the ROE stood at 14% (18% at 31 December 2017). The ROE is calculated by dividing profit attributable to the Parent by the equity attributable to the Parent.

|  | Thousand of Euros |
|  | 2018 |  | 2017 |
Profit attributable to the parent |  | 596,642 |  | 662,700 |
Equity attributable to the Parent |  | 4,225,554 |  | 3,629,079 |
ROE |  | 14 | % | 18 | %

· In accordance with the senior secured debt contract, the Group is subject to compliance with some covenants. At 31 December 2018 and 2017, the Group complies with the covenants.

· Consideration of the Company’s credit rating (see note 20 (d)).

The Parent held Class A and B treasury stock equivalent to 0.6% of its capital at 31 December 2018 (0.6% at 31 December 2017). The Group does not have a formal plan for repurchasing shares.

(6) Segment Reporting

In accordance with IFRS 8 “Operating Segments”, financial information for operating segments is reported in the accompanying Appendix II, which forms an integral part of this note to the consolidated Financial statements.

Group companies are divided into four areas: companies from the industrial area, companies from the commercial area, companies from the services area and companies from the research area. Within each of these areas, activities are organized based on the nature of the products and services manufactured and marketed.

Assets, liabilities, income and expenses for segments include directly and reliably attributable items. Items which are not attributed to segments by the Group are:

· Balance sheet: cash and cash equivalents, current income tax assets and liabilities, deferred tax assets and liabilities and loans and borrowings.

· Statement of profit and loss: finance result and income tax.

(a) Operating segments

The operating segments defined by the steering committee are as follows:

· Bioscience: including all activities related with products derived from human plasma for therapeutic use.

· Hospital: comprising all non-biological pharmaceutical products and medical supplies manufactured by Group companies earmarked for hospital pharmacy. Products related with this business which the Group does not manufacture but markets as supplementary to its own products are also included.

· Diagnostic: including the marketing of diagnostic testing equipment, reagents and other equipment, manufactured by Group or other companies.

· Bio Supplies: since January 2017, the company is including all transactions related to biological products for non-therapeutic use, Kedrion production agreements, and third-party plasma sales channeled through Haema and Biotest in the new Bio Supplies Division resulting in a reclassification from Bioscience Division to Bio Supplies Division.

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Notes to the Consolidated Financial statements

· Others: including the rendering of manufacturing services to third party companies.

As a result of the creation of the new Bio Supplies segment and the Intersegments, the Group has reviewed the allocation of balances and transactions by segments. The comparative figures for 2016 have been restated accordingly.

Details of net sales by groups of products for 2018, 2017 and 2016 are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Bioscience |  |  |  |  |  |  |
Haemoderivatives |  | 3,516,704 |  | 3,429,785 |  | 3,228,275 |
Diagnostic |  |  |  |  |  |  |
Transfusional medicine |  | 650,180 |  | 679,692 |  | 640,443 |
Other diagnostic |  | 19,797 |  | 23,377 |  | 23,540 |
Hospital |  |  |  |  |  |  |
Fluid therapy and nutrition |  | 52,574 |  | 47,699 |  | 46,210 |
Hospital supplies |  | 58,014 |  | 52,466 |  | 52,373 |
Bio supplies |  | 167,004 |  | 66,791 |  | 24,387 |
Others |  | 22,451 |  | 18,263 |  | 34,602 |
Total |  | 4,486,724 |  | 4,318,073 |  | 4,049,830 |

The Group has concluded that hemoderivative products are sufficiently alike to be considered as a whole for the following reasons:

· All these products are human plasma derivatives and are manufactured in a similar way.

· The customers and methods used to distribute these products are similar.

· All these products are subject to the same regulations regarding production and the same regulatory environment.

(b) Geographical information

Geographical information is grouped into four areas:

· United States of America and Canada

· Spain

· Rest of the European Union

· Rest of the world

The definition of these four segments is mainly due to the geographical level that the Group sets to manage its revenue as they respond to specific economic scenarios. The main framework of the Group is consistent with this geographical segment grouping, including the monitoring of its commercial operations and its information systems.

The financial information reported for geographical areas is based on sales to third parties in these markets as well as the location of assets.

(c) Main customers

In 2018 the revenue of two Bioscience segment customers represents approximately 23.1% of the Group’s total revenues. For 2017 and 2016 one Bioscience segment customer represented 11.0% and 10.7% of the Group’s total revenue, respectively.

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Notes to the Consolidated Financial statements

(7) Goodwill

Details of and movement in this caption of the consolidated balance sheet at 31 December 2017 are as follows:

|  |  |  | Thousands of Euros |
|  |  |  | Balance at |  | Business |  | Translation |  | Balance at |
|  | Segment |  | 31/12/2016 |  | Combination |  | differences |  | 31/12/2017 |
Net value |  |  |  |  |  |  |  |  |  |  |
Grifols UK.Ltd. (UK) |  | Bioscience |  | 8,025 |  | — |  | (280 | ) | 7,745 |
Grifols Italia.S.p.A. (Italy) |  | Bioscience |  | 6,118 |  | — |  | — |  | 6,118 |
Biomat USA, Inc.(USA) |  | Bioscience |  | 193,039 |  | 40,101 |  | (27,886 | ) | 205,254 |
Grifols Australia Pty Ltd. (Australia) / Medion Diagnostics AG (Switzerland) |  | Diagnostic |  | 10,134 |  | — |  | (591 | ) | 9,543 |
Grifols Therapeutics, Inc. (USA) |  | Bioscience |  | 2,108,139 |  | — |  | (255,234 | ) | 1,852,905 |
Araclon Biotech, S.L. (Spain) |  | Diagnostic |  | 6,000 |  | — |  | — |  | 6,000 |
Progenika Biopharma, S.A. (Spain) |  | Diagnostic |  | 40,516 |  | — |  | — |  | 40,516 |
Grifols Diagnostic (Novartis & Hologic) (USA, Spain and Hong Kong) |  | Diagnostic |  | 1,272,024 |  | 1,466,420 |  | (302,537 | ) | 2,435,907 |
Kiro Grifols S.L. (Spain) |  | Hospital |  | — |  | 26,510 |  | — |  | 26,510 |
|  |  |  | 3,643,995 |  | 1,533,031 |  | (586,528 | ) | 4,590,498 |
|  |  |  |  |  | (See note 3) |  |  |  |  |

Details of and movement in this caption of the consolidated balance sheet at 31 December 2018 are as follows:

|  |  |  | Thousands of Euros |
|  |  |  | Balance at |  | Business |  |  |  | Translation |  | Balance at |
|  | Segment |  | 31/12/2017 |  | Combination |  | Disposals |  | differences |  | 31/12/2018 |
Net value |  |  |  |  |  |  |  |  |  |  |  |  |
Grifols UK.Ltd. (UK) |  | Bioscience |  | 7,745 |  | — |  | — |  | (63 | ) | 7,682 |
Grifols Italia.S.p.A. (Italy) |  | Bioscience |  | 6,118 |  | — |  | — |  | — |  | 6,118 |
Biomat USA, Inc.(USA) |  | Bioscience |  | 205,254 |  | 42,780 |  | (2,827 | ) | 9,907 |  | 255,114 |
Grifols Australia Pty Ltd. (Australia) / Medion Diagnostics AG (Switzerland) |  | Diagnostic |  | 9,543 |  | — |  | — |  | (272 | ) | 9,271 |
Grifols Therapeutics, Inc. (USA) |  | Bioscience |  | 1,852,905 |  | — |  | — |  | 87,871 |  | 1,940,776 |
Araclon Biotech, S.L. (Spain) |  | Diagnostic |  | 6,000 |  | — |  | — |  | — |  | 6,000 |
Progenika Biopharma, S.A. (Spain) |  | Diagnostic |  | 40,516 |  | — |  | — |  | — |  | 40,516 |
Grifols Diagnostic (Novartis & Hologic) (USA, Spain and Hong Kong) |  | Diagnostic |  | 2,435,907 |  | — |  | — |  | 114,349 |  | 2,550,256 |
Kiro Grifols S.L. (Spain) |  | Hospital |  | 26,510 |  | (2,134 | ) | — |  | — |  | 24,376 |
Goetech LLC (USA) |  | Hospital |  | — |  | 55,321 |  | — |  | 3,624 |  | 58,945 |
Haema AG (Germany) |  | Bioscience |  | — |  | 171,134 |  | — |  | — |  | 171,134 |
Biotest Pharma Corp (USA) |  | Bioscience |  | — |  | 136,234 |  | — |  | 2,808 |  | 139,042 |
|  |  |  | 4,590,498 |  | 403,335 |  | (2,827 | ) | 218,224 |  | 5,209,230 |
|  |  |  |  |  | (See note 3) |  |  |  |  |  |  |

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Notes to the Consolidated Financial statements

Impairment testing:

As a result of the acquisition of Talecris in 2011, and for impairment testing purposes, the Group combines the CGUs allocated to the Bioscience segment, grouping them together at segment level, because substantial synergies were expected to arise on the acquisition of Talecris, and due to the vertical integration of the business and the lack of an independent organized market for the products. Because the synergies benefit the Bioscience segment globally they cannot be allocated to individual CGUs. The Bioscience segment represents the lowest level to which goodwill is allocated and is subject to control by Group management for internal control purposes.

Since the acquisition of Novartis’ Diagnostic business unit in 2014, the Group combines Araclon, Progenika, Australia and Hologic’s share of NAT donor screening unit acquisition into a single CGU for the Diagnostic business as the acquisition is supporting not only the vertically integration business but also cross-selling opportunities. In addition, for management purposes, the Group’s management is focused on the business more than geographical areas or individual companies.

Due to the acquisition of an additional 40% stake of Kiro Grifols S.L. and a 51% stake of Goetech LLC (Medkeeper), the Group decided to group Kiro Grifols S.L., Laboratorios Grifols S.L. and Medkeeper into a single CGU for the Hospital business since the acquisitions are supporting cross-selling opportunities.

The CGUs established by Management are:

· Bioscience

· Diagnostic

· Hospital

The recoverable amount of the Bioscience CGU was calculated based on its value in use calculated as the present value of the future cash flows discounted at a discount rate considering the related inherent risk.

The recoverable amount of the Diagnostic CGU was calculated based on its fair value less costs of disposal calculated as the present value of the future cash flows discounted at a discount rate considering the related inherent risk.

The recoverable amount of the Hospital CGU was calculated based on its fair value less costs of disposal calculated as the present value of the future cash flows discounted at a discount rate considering the related inherent risk.

This value in use and fair value less costs of disposal calculations use cash flow projections for five years based on the financial budgets approved by management. Cash flows estimated as of the year in which stable growth in the CGU has been reached are extrapolated using the estimated growth rates indicated below.

The key assumptions used in calculating impairment of the CGUs for 2017 were as follows:

|  | Perpetual Growth rate |  | Pre-tax discount rate |
Bioscience |  | 2 | % | 9.50 | %
Diagnostic |  | 2 | % | 10.60 | %
Hospital |  | 1.40 | % | 13.30 | %

The key assumptions used in calculating impairment of the CGUs for 2018 have been as follows:

|  | Perpetual Growth rate |  | Pre-tax discount rate |
Bioscience |  | 2 | % | 8.90 | %
Diagnostic |  | 2 | % | 9.40 | %
Hospital |  | 1.50 | % | 13.10 | %

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Notes to the Consolidated Financial statements

Management determined budgeted gross margins based on past experience, investments in progress which would imply significant growth in production capacity and its forecast international market development. Perpetual growth rates are coherent with the forecasts included in industry reports. The discount rate used reflects specific risks related to the CGU.

As the recoverable amount of the Bioscience CGU is much higher than the carrying amount of the Bioscience segment’s assets, specific information from the impairment test sensitivity analysis is not included.

At 31 December 2018 Grifols’ stock market capitalization totals Euros 13,978 million (Euros 15,379 million at 31 December 2017).

(8) Other Intangible Assets

Details of other intangible assets and movement during the years ended 31 December 2018 and 2017 are included in Appendix III, which forms an integral part of these notes to the consolidated Financial statements.

Intangible assets acquired from Talecris mainly include currently marketed products. Identifiable intangible assets correspond to Gamunex and have been recognized at fair value at the acquisition date of Talecris and classified as currently marketed products. Intangible assets recognized comprise the rights on the Gamunex product, its commercialization and distribution license, trademark, as well as relations with hospitals. Each of these components is closely linked and fully complementary, are subject to similar risks and have a similar regulatory approval process.

Intangible assets acquired from Progenika mainly include currently marketed products. Identifiable intangible assets correspond to blood, immunology and cardiovascular genotyping. These assets have been recognized at fair value at the acquisition date of Progenika and classified as currently marketed products.

The cost and accumulated amortization of currently marketed products acquired from Talecris and Progenika at 31 December 2017 is as follows:

|  | Thousands of Euros |
|  | Balance at 31/12/2016 |  | Additions |  | Translation differences |  | Balance at 31/12/2017 |
Cost of currently marketed products - Gamunex |  | 1,138,412 |  | — |  | (137,828 | ) | 1,000,584 |
Cost of currently marketed products - Progenika |  | 23,792 |  | — |  | — |  | 23,792 |
Accumulated amortisation of currently marketed products - Gamunex |  | (211,871 | ) | (35,837 | ) | 28,136 |  | (219,572 | )
Accumulated amortisation of currently marketed products - Progenika |  | (9,117 | ) | (2,379 | ) | — |  | (11,496 | )
Carrying amount of currently marketed products |  | 941,216 |  | (38,216 | ) | (109,692 | ) | 793,308 |

The cost and accumulated amortization of currently marketed products acquired from Talecris and Progenika at 31 December 2018 is as follows:

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Notes to the Consolidated Financial statements

|  | Thousands of Euros |
|  | Balance at 31/12/2017 |  | Additions |  | Translation differences |  | Balance at 31/12/2018 |
Cost of currently marketed products - Gamunex |  | 1,000,584 |  | — |  | 47,451 |  | 1,048,035 |
Cost of currently marketed products - Progenika |  | 23,792 |  | — |  | — |  | 23,792 |
Accumulated amortisation of currently marketed products - Gamunex |  | (219,572 | ) | (33,775 | ) | (11,573 | ) | (264,920 | )
Accumulated amortisation of currently marketed products - Progenika |  | (11,496 | ) | (2,379 | ) | — |  | (13,875 | )
Carrying amount of currently marketed products |  | 793,308 |  | (36,154 | ) | 35,878 |  | 793,032 |

The estimated useful life of the currently marketed products acquired from Talecris is considered limited, has been estimated at 30 years on the basis of the expected life cycle of the product (Gamunex) and is amortized on a straight-line basis.

At 31 December 2018 the residual useful life of currently marketed products is 22 years and 5 months (23 years and 5 months at 31 December 2017).

The estimated useful life of the currently marketed products acquired from Progenika is considered limited, has been estimated at 10 years on the basis of the expected life cycle of the product and is amortized on a straight-line basis.

At 31 December 2018 the residual useful life of currently marketed products acquired from Progenika is 4 years and 2 months (5 years and 2 months at 31 December 2017).

(a) Self — constructed intangible assets

At 31 December 2018 the Group has recognized Euros 58,254 thousand as self-constructed intangible assets (Euros 49,782 thousand at 31 December 2017).

(b) Purchase commitments

At 31 December 2018 the Group has intangible asset purchase commitments amounting to Euros 589 thousand (Euros 1,199 thousand at 31 December 2017).

(c) Intangible assets with indefinite useful lives and other intangibles in progress

At 31 December 2018 the Group recognizes plasma center licenses with indefinite useful lives under intangible assets for a carrying amount of Euros 26,917 thousand (Euros 26,631 thousand at 31 December 2017).

The Group has also an amount of Euros 206,087 thousand as development costs in progress (Euros 183,281 thousand at 31 December 2017).

(d) Result on disposal of intangible assets

Total profit on disposals of intangible assets in 2018 amount to Euros 8,101 thousand (Euros 83 thousand of loss in 2017) and mainly corresponds to the sale of plasma centers to Kedplasma.

(e) Impairment testing

Indefinite-lived intangible assets have been allocated to the cash-generating unit (CGU) of the Bioscience segment. These assets have been tested for impairment together with goodwill (see note 7).

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Notes to the Consolidated Financial statements

Impairment testing has been analyzed for each of the intangible assets in progress by calculating its recoverable amount based on their fair value.

On 29 January 2018 (prior to the date that the 2017 consolidated Financial statements were authorized for issued) Aradigm communicated that it had not obtained the approval of the Antimicrobial Drugs Advisory Committee of the US Food and Drug Administration (FDA) for LinahiqTM. As the Committee did not recommend it as a treatment for non-cystic fibrosis bronchiectasis patients with chronic lung Pseudomonas aeruginosa infections, the intangible assets related to the product have been totally impaired and recognized as R&D expense in the statement of profit and loss for 2017 for an amount of Euros 63,675 thousand. In 2017 the investment in this company and the bonds that the Group held with the company were impaired.

(9) Property, Plant and Equipment

Details of property, plant and equipment and movement in the consolidated balance sheet at 31 December 2018 and 2017 are included in Appendix IV, which forms an integral part of this note to the consolidated Financial statements.

Property, plant and development under construction at 31 December 2018 and 2017 mainly comprise investments made to extend the companies’ equipment and to increase their productive capacity.

In 2018, the Group has capitalized interests for a total amount of Euros 8,955 thousand (Euros 8,839 thousand in 2017)

a) Insurance

Group policy is to contract sufficient insurance coverage for the risk of damage to property, plant and equipment. At 31 December 2018 the Group has a combined insurance policy for all Group companies, which more than adequately covers the carrying amount of all the Group’s assets.

b) Losses on disposal of property, plant and equipment

Total losses incurred on disposals of property, plant and equipment for 2018 amount to Euros 1,401 thousand (Euros 1,468 thousand of loss in 2017).

c) Assets under finance lease

The Group contracted the following types of property, plant and equipment under finance leases at 31 December 2017:

|  | Thousands of Euros |
|  | Cost |  | Accumulated depreciation |  | Carrying amount |
Land and buildings |  | 2,545 |  | (815 | ) | 1,730 |
Plant and machinery |  | 14,249 |  | (6,564 | ) | 7,685 |
|  | 16,794 |  | (7,379 | ) | 9,415 |

The Group has contracted the following types of property, plant and equipment under finance leases at 31 December 2018:

|  | Thousands of Euros |
|  | Cost |  | Accumulated depreciation |  | Carrying amount |
Land and buildings |  | 2,389 |  | (898 | ) | 1,491 |
Plant and machinery |  | 15,690 |  | (7,237 | ) | 8,453 |
|  | 18,079 |  | (8,135 | ) | 9,944 |

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Notes to the Consolidated Financial statements

Details of minimum lease payments and the present value of finance lease liabilities, disclosed by maturity date, are detailed in note 20 (c).

d) Self — constructed property, plant and equipment

At 31 December 2018 the Group has recognized Euros 66,995 thousand as self -constructed property, plant and equipment (Euros 52,218 thousand at 31 December 2017).

e) Purchase commitments

At 31 December 2018 the Group has property, plant and equipment purchase commitments amounting to Euros 47,148 thousand (Euros 39,675 thousand at 31 December 2017).

f) Impairment

A group of assets forming part of the Hospital segment has been tested for impairment due to the decrease in the results of the segment and no impairment has been observed. The recoverable amount of the aforementioned assets is calculated based on the fair value less cost of disposal, using cash flow projections based on five-year financial budgets approved by management. Cash flows estimated as of the year in which stable growth has been reached by the assets are extrapolated using a pre-tax discount rate of 10.1% and a perpetual growth rate of 2% (12.2% and 2% respectively in fiscal year 2017).

(10) Equity Accounted Investees

Details of this caption in the consolidated balance sheet at 31 December 2018 and 2017 are as follows:

|  |  |  | Thousands of Euros |  |  |  | Thousands of Euros |
|  | % ownership |  | 31/12/2018 |  | % ownership |  | 31/12/2017 |
Alkahest, Inc. |  | 47.58 | % | 28,336 |  | 47.58 | % | 30,559 |
Albajuna Therapeutics, S.L |  | 30.00 | % | 1,106 |  | 30.00 | % | 1,956 |
Interstate Blood Bank, Inc. |  | 49.19 | % | 29,595 |  | 49.19 | % | 27,936 |
Bio Blood Components Inc. |  | 48.97 | % | 38,223 |  | 48.97 | % | 32,960 |
Plasma Biological Services, LLC |  | 48.90 | % | 21,809 |  | 48.90 | % | 23,010 |
Singulex, Inc. |  | 19.33 | % | 19,256 |  | 19.33 | % | 29,322 |
GigaGen, Inc |  | 43.96 | % | 28,363 |  | 43.96 | % | 29,047 |
Access Biologicals LLC |  | 49.00 | % | 47,742 |  | 49.00 | % | 44,219 |
Aigües de Vilajuïga, S.A. |  | — |  | — |  | 50.00 | % | — |
Plasmavita HealthCare |  | 50.00 | % | 9,920 |  | — |  | — |
Mecwins, S.A. |  | 24.99 | % | 2,555 |  | — |  | — |
|  |  |  | 226,905 |  |  |  | 219,009 |

Movement in the investments in equity-accounted investees for the years ended at 31 December 2018, 2017 and 2016 have been as follows:

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Notes to the Consolidated Financial statements

|  | Thousands of Euros |
|  | 2018 |  | 2017 |  | 2016 |
Balance at 1 January |  | 219,009 |  | 201,345 |  | 76,728 |
Acquisitions |  | 12,222 |  | 80,685 |  | 136,072 |
Transfers |  | 500 |  | (16,000 | ) | (29,059 | )
Share of profit / (losses) |  | (11,038 | ) | (13,195 | ) | 6,933 |
Share of other comprehensive income / translation differences |  | 9,270 |  | (27,134 | ) | 10,671 |
Losses for Impairment |  | — |  | (6,692 | ) | — |
Collected dividends |  | (3,058 | ) | — |  | — |
Balance at 31 December |  | 226,905 |  | 219,009 |  | 201,345 |

Mecwins, S.A.

On 22 October, 2018 Grifols has allocated Euros 2 million to the capital increase of Mecwins through Progenika Biopharma, reaching 24.99% of the total capital.

Mecwins is a spin-off of the Institute of Micro and Nanotechnology of the Center for Scientific Research (CSIC), specialized in the development of innovative nanotechnological analysis tools for the diagnosis and prognosis of diseases.

Mecwins has developed ultrasensitive optical reading immunoassay technology from nanosensors for the detection of protein biomarkers in blood. This technology has potential applications in fields such as oncology, cardiovascular and infectious diseases.

The injection of capital, in which CRB Inverbio has also participated with an additional Euros 2 million, will enable Mecwins to start developing pre-commercial prototypes of this technology and for Grifols to position itself in the field of nanotechnology applied to diagnosis.

Plasmavita Healthcare GmbH

Refer to note 3 for details of this investment.

GigaGen Inc.

On 5 July 2017, Grifols through its 100% subsidiary Grifols Innovation and New Technologies Limited (“GIANT”) acquired a 43.96% shareholding in GigaGen, Inc., a company based in San Francisco (USA) for the amount of US Dollars 35 million.

GIANT and GigaGen entered into a Research and Collaboration Agreement whereby in exchange of a collaboration fee of US Dollars 15 million in the aggregate, GigaGen will commit to carry out research activities to develop recombinant polyclonal immunoglobulin therapies derived from human B cells for the treatment of human diseases.

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Notes to the Consolidated Financial statements

Movement in Gigagen’s equity-accounted investment for the years ended 31 December 2018 and 2017 is as follows:

|  | Thousand of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Balance at 1 January |  | 29,047 |  | — |
Acquisitions |  | — |  | 31,752 |
Share of profit / (losses) |  | (1,562 | ) | (804 | )
Share of other comprehensive income / translation differences |  | 878 |  | (1,595 | )
Pérdidas por deterioro de valor |  | — |  | (306 | )
Balance at 31 December |  | 28,363 |  | 29,047 |

Access Biologicals LLC.

On 12 January 2017, the group announced the acquisition of 49% of the voting rights in Access Biologicals LLC, a company based in San Diego, California, USA, for the amount of US Dollars 51 million. Grifols entered into an option agreement to purchase the remaining 51% voting rights in five years, in 2022. Grifols also signed a supply agreement to sell to Access Biologicals biological products not meant for therapeutic use.

The principal business activity of Access Biologicals is the collection and manufacturing of an extensive portfolio of biologicals products. Combined with closed-loop material sourcing, it provides critical support for various markets such as in-vitro diagnostic manufacturing, biopharmaceutical, cell culture and diagnostic research & development.

Movement in Access Biological’s equity-accounted investment for the years ended 31 December 2017 and 2018 is as follows:

|  | Thousand of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Balance at 1 January |  | 44,219 |  | — |
Acquisitions |  | — |  | 48,383 |
Share of profit / (losses) |  | 3,039 |  | 1,830 |
Share of other comprehensive income / translation differences |  | 2,073 |  | (5,994 | )
Collected dividends |  | (1,589 | ) | — |
Balance at 31 December |  | 47,742 |  | 44,219 |

Singulex, Inc.

On 17 May 2016 Grifols subscribed and paid a capital increase for an amount of US Dollars 50 million (Euros 44,107 thousand) in the US company Singulex, Inc. (“Singulex”). As a result, Grifols holds a 19.33% common stock interest in Singulex on a fully diluted basis at a pre-money valuation of US Dollars 200 million. Grifols will be entitled to appoint a director to serve the board of directors of Singulex. As a result, Singulex granted Grifols an exclusive worldwide license for the use and sale of Singulex’ technology for the blood donor and plasma screening to further ensure the safety of blood and plasma products.

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Notes to the Consolidated Financial statements

Movement in Singulex, Inc.’s equity-accounted investment for the years ended 31 December 2018 and 2017 is as follows:

|  | Thousand of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Balance at 1 January |  | 29,322 |  | 43,329 |
Share of profit / (losses) |  | (10,975 | ) | (9,335 | )
Share of other comprehensive income / translation differences |  | 909 |  | (4,672 | )
Balance at 31 December |  | 19,256 |  | 29,322 |

Interstate Blood Bank, Inc., Bio-Blood Components, Inc. and Plasma Biological Services, Llc.

On 11 May 2016 Grifols acquired a 49.19% stake in Interstate Blood Bank, Inc. (IBBI), 48.97% of Bio-Blood Components, Inc. (Bio-Blood) and 48.90% of Plasma Biological Services, LLC. (PBS) (“IBBI Group”), a group based in Memphis, USA, for the price of US Dollars 100 million (Euros 88,215 thousand). GWWO also entered into an option agreement to purchase the remaining stakes for a price of US Dollars 100 million for an option price of US Dollars 10 million (Euros 9,007 thousand) (see notes 11 and 30). The purchase price and the call right were paid upon signature of the contract. The principal business activity of IBBI and its affiliates is the collection of plasma for the plasma fractionation industry, with 23 plasma collection centers, 9 blood donation centers and one laboratory.

Movement in Interstate Blood Bank, Inc., Bio-blood Components, Inc. and Plasma Biological Services, LLC.’s equity-accounted investment for the years ended 31 December 2017 and 2018 is as follows:

|  | Thousands of Euros |  | Thousands of Euros |  |  |  |  |
|  | 31/12/2018 |  | 31/12/2017 |  |  |  |  |
|  | IBBI |  | Bio-Blood |  | PBS |  | IBBI |  | Bio-Blood |  | PBS |  | TOTAL 2018 |  | TOTAL 2017 |
Balance at 1 January |  | 27,936 |  | 32,960 |  | 23,010 |  | 31,090 |  | 38,725 |  | 25,890 |  | 83,906 |  | 95,705 |
Share of profit / (losses) |  | 1,830 |  | 3,492 |  | (2,181 | ) | 635 |  | (1,181 | ) | 270 |  | 3,141 |  | (276 | )
Share of other comprehensive income / translation differences |  | 1,298 |  | 1,771 |  | 980 |  | (3,789 | ) | (4,584 | ) | (3,150 | ) | 4,049 |  | (11,523 | )
Collected dividend |  | (1,469 | ) | — |  | — |  | — |  | — |  | — |  | (1,469 | ) | — |
Balance at 31 December |  | 29,595 |  | 38,223 |  | 21,809 |  | 27,936 |  | 32,960 |  | 23,010 |  | 89,627 |  | 83,906 |

Kiro Grifols, S.L.

On 25 July 2017 the Group acquired an additional 40% interest in Kiro Grifols, S.L (formerly Kiro Robotics, S.L.) for an amount of Euros 12.8 million. With this new acquisition, Grifols owns 90% in Kiro Grifols S.L., which is now considered part of the group, and starts using the global consolidation method instead of the equity method (see note 3(b)).

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Notes to the Consolidated Financial statements

(11) Financial Assets

Details of non-current financial assets on the consolidated balance sheet at 31 December 2018 and 2017 are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Non-current derivatives (see note 30) |  | — |  | 8,338 |
Financial investments in shares with stock market (a) |  | 7 |  | 38,708 |
Total Non-current financial assets measured at fair value |  | 7 |  | 47,046 |
Non-current guarantee deposits |  | 5,566 |  | 4,820 |
Other non-current financial assets |  | 1,908 |  | 1,346 |
Non-current loans to related parties (see note 31) |  | 82,969 |  | — |
Non-current loans to EEAA (c) (see note 31) |  | 17,151 |  | 16,677 |
Total Non-current financial assets measured at amortized cost |  | 107,594 |  | 22,843 |

Details of other current financial assets on the consolidated balance sheet at 31 December 2018 and 2017 are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Current derivatives (b) (see note 30) |  | 19,934 |  | — |
Total Non-current financial assets measured at fair value |  | 19,934 |  | — |

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Deposits and guarantees |  | 822 |  | 702 |
Current loans to third parties |  | 56 |  | 59 |
Current loans to associates (c) (see note 31) |  | 33,153 |  | 9,977 |
Total other current financial assets |  | 34,031 |  | 10,738 |

(a) Financial investments in quoted shares

Within the framework of its integrated R & D & I strategy, which assesses the adequacy of the various projects, Grifols made the decision to divest in TiGenix and participated in the takeover bid by Takeda in the first half of 2018. Divestment has generated a cash inflow of Euros 70.1 million and a positive impact on the consolidated profit of Euros 32 million (see note 26).

(b) Current derivatives

At 31 December 2018, current derivatives correspond to the purchase options described below:

· Option to purchase the non-acquired shares of Interstate Blood Bank, Inc., Bio-Blood Components, Inc. and Plasma Biological Services, LLC. The purchase option may be exercised by the Group by written notification at any time between 1 February 2019 and 30 April 2019 (see note 30).

· Option to purchase Biotest Pharmaceuticals Corporation over two donation centers of ADMA Centers. The execution of the purchase option was executed on 1 January 2019 (see note 30).

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Notes to the Consolidated Financial statements

(c) Non-current loans to EEAA

On 2 October 2017 the Group’s subsidiary Grifols Diagnostic Solutions, Inc. granted a loan to Singulex Inc. of US Dollars 20,000 thousand (Euros 16,676 thousand), that bear at an interest rate of 5% and mature on 19 September 2019. In the first half of 2018, the Group made an additional contribution amounting to US Dollars 12,339 (Euros 11,063 thousand). The Group owns 19.33 % of the common stock of Singulex Inc.

On 8 February 2017, the subsidiary Grifols Worldwide Operations granted a loan of US Dollars 11,000 thousand (Euros 10,809 thousand) to Interstate Blood Bank Inc, with interest at a rate of 4% and due on 6 February 2022. The Group owns 49.19% of the capital of Interstate Blood Bank Inc.

(12) Inventories

Details of inventories at 31 December 2018 and 2017 are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Goods for resale |  | 118,876 |  | 105,013 |
Raw materials and supplies |  | 647,399 |  | 454,371 |
Work in progress and semi-finished goods |  | 744,436 |  | 592,612 |
Finished goods |  | 438,649 |  | 477,297 |
|  | 1,949,360 |  | 1,629,293 |

Movement in the inventory provision was as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Balance at 1 January |  | 35,764 |  | 33,069 |  | 22,614 |
Net charge for the year |  | 10,398 |  | 8,232 |  | 8,878 |
Cancellations for the year |  | (558 | ) | (357 | ) | (20 | )
Translation differences |  | 3,236 |  | (5,180 | ) | 1,597 |
Balance at 31 December |  | 48,840 |  | 35,764 |  | 33,069 |

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Notes to the Consolidated Financial statements

(13) Trade and Other Receivables

Details at 31 December 2018 and 2017 are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Trade receivables |  | 289,316 |  | 302,685 |
Receivables from associates (note 31) |  | 382 |  | 3,219 |
Bad debt provision (note 30) |  | (20,531 | ) | (19,706 | )
Trade receivables |  | 269,167 |  | 286,198 |
Other receivables (note 30) |  | 9,901 |  | 7,485 |
Personnel |  | 2,082 |  | 566 |
Advance payments (note 30) |  | 35,426 |  | 11,181 |
Taxation authorities, VAT recoverable |  | 42,707 |  | 20,105 |
Other public entities |  | 2,302 |  | 1,344 |
Other receivables |  | 92,418 |  | 40,681 |
Current income tax assets |  | 42,205 |  | 59,531 |
|  | 403,790 |  | 386,410 |

Other receivables

During 2018, 2017 and 2016 certain companies of the Grifols Group have sold receivables from several public entities, without recourse, to certain financial institutions. Under some of these contracts, the Group receives an initial payment which usually amounts to 90% of the nominal amount of the receivables sold less the associated sale and purchase costs. The deferred collection (equivalent to the rest of the nominal amount) will be made by the Group once the financial institution has collected the nominal amount of the receivables (or the interest, if the balances are received after more than 36 months, depending on the terms of each particular contract) and this amount is recognized in the consolidated balance sheet as a balance receivable from the financial institution. The deferred amount (equivalent to the continuing involvement) totals Euros 1,220 thousand at 31 December 2018 (Euros 1,800 thousand at 31 December 2017), which does not differ significantly from its fair value and coincides with the amount of maximum exposure to losses. The financial institution makes the initial payment when the sale is completed and therefore, the bad debt risk associated with this part of the nominal amount of the receivables is transferred. The Group has transferred the credit risk and control of the receivables to certain financial institutions and has therefore derecognized the asset transferred in the consolidated balance sheet, as the risks and rewards inherent to ownership have not been substantially retained.

Certain foreign Group companies have also entered into a contract to sell receivables without recourse to various financial institutions.

Total balances receivable without recourse sold to financial institutions through the aforementioned contracts in 2018 amount to Euros 1,188,216 thousand (Euros 912,204 thousand in 2017 and Euros 870,324 thousand in 2016).

The finance cost of these operations for the Group totals approximately Euros 6,053 thousand which has been recognized under finance costs in the consolidated statement of profit and loss for 2018 (Euros 3,973 thousand in 2017 and Euros 4,885 thousand in 2016) (see note 26).

Details of balances with related parties are shown in note 31.

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Notes to the Consolidated Financial statements

(14) Cash and Cash Equivalents

Details of this caption of the consolidated balance sheet at 31 December 2018 and 2017 are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Current deposits |  | 441,614 |  | 655,463 |
Cash in hand and at banks |  | 592,178 |  | 231,058 |
Total cash and cash equivalents |  | 1,033,792 |  | 886,521 |

(15) Equity

Details of consolidated equity and movement are shown in the consolidated statement of changes in equity.

(a) Share capital

At 31 December 2018 and 2017, the Company’s share capital amounts to Euros 119,603,705 and comprises:

· Class A shares: 426,129,798 ordinary shares of Euros 0.25 par value each, subscribed and fully paid and of the same class and series.

· Class B shares: 261,425,110 non-voting preference shares of 0.05 Euros par value each, of the same class and series, and with the preferential rights set forth in the Company’s by-laws.

The main characteristics of the Class B shares are as follows:

· Each Class B share entitles its holder to receive a minimum annual preferred dividend out of the distributable profits at the end of each year equal to Euros 0.01 per Class B share provided that the aggregate preferred dividend does not exceed the distributable profits of that year and a distribution of dividends has been approved by the Company’s shareholders. This preferred dividend is not cumulative if sufficient distributable profits are not obtained in the period.

· Each Class B share is entitled to receive, in addition to the above-mentioned preferred dividend, the same dividends and other distributions as for one Grifols ordinary share.

· Each Class B share entitles the holder to its redemption under certain circumstances, if a takeover bid for all or part of the shares in the Company has been made, except if holders of Class B shares have been entitled to participate in the bid on the same terms as holders of Class A shares. The redemption terms and conditions reflected in the Company’s by-laws limit the amount that may be redeemed, requiring that sufficient distributable reserves be available, and limit the percentage of shares to be redeemed in line with the ordinary shares to which the bid is addressed.

· In the event the Company were to be wound up and liquidated, each Class B share entitles the holder to receive, before any amounts are paid to holders of ordinary shares, an amount equal to the sum of (i) the par value of the Class B share, and (ii) the share premium paid for the Class B share when it was subscribed. In addition to the Class B liquidation preference amount, each holder is entitled to receive the same liquidation amount that is paid for each ordinary share.

These shares are freely transferable.

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Notes to the Consolidated Financial statements

Since 23 July 2012 the ADSs (American Depositary Shares) representing Grifols’ Class B shares (non-voting shares) have had an exchange ratio of 1:1 in relation to Class B shares, ie.1 ADS represents 1 Class B share. The previous rate was 2 ADS per 1 Class B share.

The Company’s knowledge of its shareholders is based on information provided voluntarily or in compliance with applicable legislation. According to the information available to the Company, there are no interests representing more than 10% of the Company’s total capital at 31 December 2018 and 2017.

At 31 December 2018 and 2017, the number of outstanding shares is equal to the total number of Company shares, less treasury stock.

Movement in outstanding shares during 2017 is as follows:

|  | Class A shares |  | Class B shares |
Balance at 1 January 2017 |  | 426,129,798 |  | 256,694,375 |
(Acquisition) / disposal of treasury stock (note 15 (d)) |  | — |  | 432,929 |
Balance at 31 December 2017 |  | 426,129,798 |  | 257,127,304 |

Movement in outstanding shares during 2018 is as follows:

|  | Class A shares |  | Class B shares |
Balance at 1 January 2018 |  | 426,129,798 |  | 257,127,304 |
(Acquisition) / disposal of treasury stock (note 15 (d)) |  | — |  | 479,355 |
Balance at 31 December 2018 |  | 426,129,798 |  | 257,606,659 |

(b) Share premium

Movement in the share premium is described in the consolidated statement of changes in equity, which forms an integral part of this note to the consolidated Financial statements.

(c) Reserves

The drawdown of accumulated gains is subject to legislation applicable to each of the Group companies. At 31 December 2018, Euros 35,613 thousand equivalent to the carrying amount of development costs pending amortization of certain Spanish companies (Euros 40,061 thousand at 31 December 2017) (see note 8) are, in accordance with applicable legislation, restricted reserves which cannot be distributed until these development costs have been amortized.

In July 2016 the Group acquired an additional 20% of the assets of Medion Diagnostics AG in exchange for 59,951 treasury stocks (Class B Shares) from its non-controlling interests. After these capital increases, Grifols’ interest rose to 100% in 2016. The difference between the share capital increase carried out by the Group and the non-controlling interest was recognized as a Euros 0.6 million decrease in reserves.

In August 2016 Araclon Biotech, S.L. increased capital by an amount of Euros 6.7 million. As a result, the Group increased its investment from 70.83% to 73.22%. The difference between the share capital increase carried out by the Group and the non-controlling interest was recognized as a Euros 1.7 million decrease in reserves.

On 12 December 2016, the Group subscribed a share capital increase in the capital of VCN Biosciences, S.L. of Euros 5 million. After this capital increase, Grifols interest rose to 81.34% in 2016. The difference between the share capital increase carried out by the Group and the non-controlling interest was recognized as a Euros 1 million decrease in reserves.

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Notes to the Consolidated Financial statements

In October 2017, the Group acquired 12,020 Progenika Biopharma, S.A. shares As a result, the Group has increased its investment from 89.25% to 90.23%. The difference between the share capital increase carried out by the Group and the non-controlling interest has been recognized as a Euros 374 thousand decrease in reserves.

In June 2018, Grifols made the decision to divest in TiGenix and participated in the takeover bid made by Takeda in the first half of 2018. This divestment has generated a positive impact on reserves of Euros 4,900 thousand and a negative impact of Euros 4,900 thousand in “Other comprehensive income”.

In June 2018, Grifols executed the purchase option for 6.41% of the shares of Progenika owned by Ekarpen Private Equity, S.A. for an amount of Euros 5,300 thousand. As a result, the Group increased its interest from 90.23% to 96.64%. The difference between the acquisition carried out by the Group and the non-controlling interest was recognized in reserves.

In September 2018, the Group acquired 41,387 shares of Progenika Biopharma, S.A for an amount of Euros 4,333 thousand. As a result, the Group increased its interest from 96.64% to 99.99%. The difference between the acquisition carried out by the Group and the non-controlling interest was recognized against reserves.

At 31 December 2018 and 2017 reserves include the IFRS-EU first-time adoption revaluation reserves and legal reserve of certain Group companies.

Legal reserve

Companies in Spain are obliged to transfer 10% of each year’s profits to a legal reserve until this reserve reaches an amount equal to 20% of share capital. This reserve is not distributable to shareholders and may only be used to offset losses if no other reserves are available. Under certain conditions it may be used to increase share capital provided that the balance left on the reserve is at least equal to 10% of the nominal value of the total share capital after the increase.

At 31 December 2018 and 2017 the legal reserve of the Company amounts to Euros 23,921 thousand, which corresponds to 20% of the share capital.

Distribution of the legal reserves of Spanish companies is subject to the same restrictions as those of the Company and at 31 December 2018 the balance of the legal reserve of other Spanish companies amounts to Euros 2,527 thousand (Euros 2,416 thousand at 31 December 2017).

Other foreign Group companies have a legal reserve amounting to Euros 843 thousand at 31 December 2018 (Euros 731 thousand at 31 December 2017).

(d) Treasury stock

At 31 December 2018 and December 2017 the Company does not have any Class A treasury stock.

Movement in Class B treasury stock during 2017 was as follows:

|  | No. of Class B shares |  | Thousands of Euros |
Balance at 1 January 2017 |  | 4,730,735 |  | 68,710 |
Disposal Class B shares |  | (432,929 | ) | (6,288 | )
Balance at 31 December 2017 |  | 4,297,806 |  | 62,422 |

Movement in Class B treasury stock during 2018 is as follows:

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Notes to the Consolidated Financial statements

|  | No. of Class B shares |  | Thousands of Euros |
Balance at 1 January 2018 |  | 4,297,806 |  | 62,422 |
Disposal Class B shares |  | (479,355 | ) | (6,981 | )
Balance at 31 December 2018 |  | 3,818,451 |  | 55,441 |

In March 2018 the Group delivered 480,661 treasury stocks (Class B shares) to eligible employees as compensation for the Restricted Share Unit Retention Plan (see note 29).

In March 2017 the Group delivered 432,929 treasury stocks (Class B shares) to eligible employees as a compensation for the Restricted Share Unit Retention Plan (see note 29).

The Parent held Class B treasury stock equivalent to 0.6% of its capital at 31 December 2018 (0.6% at 31 December 2017).

(e) Distribution of profit

The profits of Grifols, S.A. and subsidiaries will be distributed as agreed by respective shareholders at their general meetings.

The proposed distribution of profit of the Parent Grifols, S.A. for the years ended 31 December 2018, and the distribution of profit approved for 2017, presented at the general meeting held on 25 May 2018, is as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Voluntary reserve |  | 91,059 |  | 76,247 |
Dividends |  | 238,659 |  | 265,080 |
Profit of the Parent |  | 329,718 |  | 341,327 |

The following dividends were paid in 2017:

|  | 31/12/2017 |
|  | % of par value |  | Euros per share |  | Thousands of Euros |
Ordinary shares |  | 54 | % | 0.14 |  | 57,790 |
Non-voting shares |  | 271 | % | 0.14 |  | 34,870 |
Non-voting shares (preferred dividend) |  | 20 | % | 0.01 |  | 2,614 |
Total dividends paid |  |  |  |  |  | 95,274 |

|  | 31/12/2017 |
|  | % of par value |  | Euros per share |  | Thousands of Euros |
Ordinary shares (interim dividend) |  | 72 | % | 0.18 |  | 76,703 |
Non-voting shares (interim dividend) |  | 360 | % | 0.18 |  | 46,283 |
Total interim dividends paid |  |  |  |  |  | 122,986 |

The following dividends were paid in 2018:

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|  | 31/12/2018 |
|  | % of par value |  | Euros per share |  | Thousands of Euros |
Ordinary shares |  | 82 | % | 0.20 |  | 86,929 |
Non-voting shares |  | 408 | % | 0.20 |  | 52,551 |
Non-voting shares (preferred dividend) |  | 20 | % | 0.01 |  | 2,614 |
Total dividends paid |  |  |  |  |  | 142,094 |

|  | 31/12/2018 |
|  | % of par value |  | Euros per share |  | Thousands of Euros |
Ordinary shares (interim dividend) |  | 80 | % | 0.2 |  | 85,226 |
Non-voting shares (interim dividend) |  | 400 | % | 0.2 |  | 51,521 |
Total interim dividends paid |  |  |  |  |  | 136,747 |

At the meeting held on 26 October, 2018, the Board of Directors of Grifols approved the distribution of interim dividend for 2018, of Euros 0.20 for each Class A and B share, recognizing a total of Euros 136,747 thousand as interim dividend.

At the meeting held on 27 October 2017, the Board of Directors of Grifols approved the distribution of interim dividend for 2017 of Euros 0.18 for each Class A and B share, recognizing a total of Euros 122,986 thousand as interim dividend.

These amounts to be distributed did not exceed the profits generated by the Company since the end of the last reporting period, less the estimated income tax payable on these profits, in accordance with article 277 of the Revised Spanish Companies Act.

The Statement of Liquidity for Distribution of Interim Dividend of Grifols, S.A. prepared in accordance with legal requirements and which shows the existence of sufficient liquidity to be able to distribute the aforementioned interim dividend is provided in Appendix V.

At a general meeting held on 25 May 2018 the shareholders approved the distribution of a preferred dividend of Euros 0.01 for every Class B non-voting share.

The distribution of the profit for the years ended 31 December 2017 and 2018 is presented in the consolidated statement of changes in equity.

(f) Restricted Share Unit Retention Plan

The Group has set up a Restricted Share Unit Retention Plan (hereinafter RSU Plan) for certain employees (see note 29). This commitment will be settled using equity instruments and the cumulative accrual amounts to Euros 12,652 thousand at 31 December 2018 (Euros 13,871 thousand at 31 December 2017).

(16) Earnings Per Share

The calculation of basic earnings per share is based on the profit for the year attributable to the shareholders of the Parent divided by the weighted average number of ordinary shares in circulation throughout the year, excluding treasury stock.

Details of the calculation of basic earnings per share are as follows:

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Notes to the Consolidated Financial statements

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Profit for the year attributable to shareholders of the Parent (thousands of Euros) |  | 596,642 |  | 662,700 |  | 545,456 |
Weighted average number of ordinary shares outstanding |  | 684,709,377 |  | 684,197,276 |  | 683,225,815 |
Basic earnings per share (Euros per share) |  | 0.87 |  | 0.97 |  | 0.80 |

The weighted average of the ordinary shares outstanding (basic) has been calculated taking into consideration the share split carried out on 4 January 2016 as follows:

|  | Number of shares |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Issued shares outstanding at 1 January |  | 684,346,294 |  | 683,854,491 |  | 683,516,338 |
Effect of shares issued |  | — |  | — |  | — |
Effect of treasury stock |  | 363,083 |  | 342,785 |  | (290,523 | )
Average weighted number of ordinary shares outstanding (basic) at 31 December |  | 684,709,377 |  | 684,197,276 |  | 683,225,815 |

Diluted earnings per share are calculated by dividing profit for the year attributable to shareholders of the Parent by the weighted average number of ordinary shares in circulation considering the diluting effects of potential ordinary shares.

The RSU Plan granted by the Group and payable in shares, assumes the existence of dilutive potential shares. Diluted earnings per share have been calculated as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Profit for the year attributable to shareholders of the Parent (thousands of Euros) |  | 596,642 |  | 662,700 |  | 545,456 |
Weighted average number of ordinary shares outstanding (diluted) |  | 684,686,164 |  | 684,243,891 |  | 684,170,887 |
Diluted earnings per share (Euros per share) |  | 0.87 |  | 0.97 |  | 0.80 |

The weighted average number of ordinary shares outstanding diluted has been calculated as follows:

|  | Number of shares |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Issued shares outstanding at 1 January |  | 684,346,294 |  | 683,854,491 |  | 683,988,460 |
Effect of RSU shares |  | (23,213 | ) | 46,615 |  | 472,950 |
Effect of shares issued |  | — |  | — |  | — |
Effect of treasury stock |  | 363,083 |  | 342,785 |  | (290,523 | )
Average weighted number of ordinary shares outstanding (diluted) at 31 December |  | 684,686,164 |  | 684,243,891 |  | 684,170,887 |

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Notes to the Consolidated Financial statements

(17) Non-Controlling Interests

Details of non-controlling interests and movement at 31 December 2017 are as follows:

|  | Thousands of Euros |
|  | Balance at 31/12/2016 |  | Additions |  | Disposals |  | Business Combination / Additions to Consolidated Group |  | Translation differences |  | Balance at 31/12/2017 |
Grifols (Thailand) Pte Ltd |  | 3,354 |  | 433 |  | (77 | ) | — |  | (131 | ) | 3,579 |
Grifols Malaysia Sdn Bhd |  | 1,172 |  | 229 |  | — |  | — |  | (29 | ) | 1,372 |
Araclon Biotech, S.A. |  | 140 |  | (1,617 | ) | — |  | — |  | — |  | (1,477 | )
Progenika Biopharma, S.A. |  | 1,211 |  | (60 | ) | (298 | ) | — |  | 27 |  | 880 |
Abyntek Biopharma, S.L. |  | (73 | ) | 45 |  | 28 |  | — |  | — |  | — |
VCN Bioscience, S.L |  | 693 |  | (272 | ) | — |  | — |  | — |  | 421 |
Kiro Grifols , S.L. |  | — |  | (144 | ) | — |  | 255 |  | — |  | 111 |
|  | 6,497 |  | (1,386 | ) | (347 | ) | 255 |  | (133 | ) | 4,886 |

Details of non-controlling interests and movement at 31 December 2018 are as follows:

|  | Thousands of Euros |
|  | Balance at 31/12/2017 |  | Additions |  | Disposals |  | Business Combination / Additions to Consolidated Group |  | Translation differences |  | Balance at 31/12/2018 |
Grifols (Thailand) Pte Ltd |  | 3,579 |  | 193 |  | (43 | ) | — |  | 206 |  | 3,935 |
Grifols Malaysia Sdn Bhd |  | 1,372 |  | 326 |  | — |  | — |  | 37 |  | 1,735 |
Araclon Biotech, S.A. |  | (1,477 | ) | (2,011 | ) | — |  | — |  | — |  | (3,488 | )
Progenika Biopharma, S.A. |  | 880 |  | — |  | (871 | ) | — |  | — |  | 9 |
VCN Bioscience, S.L |  | 421 |  | (281 | ) | — |  | — |  | — |  | 140 |
Kiro Grifols , S.L. |  | 111 |  | (463 | ) | — |  | — |  | — |  | (352 | )
Haema AG |  | — |  | — |  | — |  | 220,190 |  | — |  | 220,190 |
Biotest Pharma Corp |  | — |  | — |  | — |  | 249,691 |  | (810 | ) | 248,881 |
|  | 4,886 |  | (2,236 | ) | (914 | ) | 469,881 |  | (567 | ) | 471,050 |

(18) Grants

Details are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Capital grants |  | 11,149 |  | 11,010 |
Interest rate grants (preference loans) (See note 20 (e)) |  | 696 |  | 812 |
|  | 11,845 |  | 11,822 |

Interest-rate grants (preference loans) reflect the implicit interest on loans extended by the Spanish Ministry of Science and Technology as these are interest free.

Grants totaling Euros 1,166 thousand have been recognized in the consolidated statement of profit and loss for the year ended at 31 December 2018 (Euros 323 thousand for the year ended at 31 December 2017).

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Notes to the Consolidated Financial statements

(19) Provisions

Details of provisions at 31 December 2018 and 2017 are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Non-current provisions (a) |  |  |  |  |
Provisions for pensions and similar obligations |  | 5,296 |  | 4,742 |
Other provisions |  | 818 |  | 1,021 |
Non-current provisions |  | 6,114 |  | 5,763 |

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Current provisions (b) |  |  |  |  |
Trade provisions |  | 80,055 |  | 106,995 |
Current provisions |  | 80,055 |  | 106,995 |

(a) Non-current provisions

At 31 December 2018, 2017 and 2016 provisions for pensions and similar obligations mainly comprise a provision made by certain foreign subsidiaries in respect of labor commitments with certain employees.

Movement in provisions during 2016 was as follows:

|  | Thousands of Euros |
|  | Balance at |  |  |  |  |  |  |  | Translation |  | Balance at |
|  | 31/12/2015 |  | Net charge |  | Cancellations |  | Reclassifications |  | differences |  | 31/12/2016 |
Non-current provisions |  | 4,980 |  | (399 | ) | (281 | ) | 814 |  | 4 |  | 5,118 |
|  | 4,980 |  | (399 | ) | (281 | ) | 814 |  | 4 |  | 5,118 |

Movement in provisions during 2017 was as follows:

|  | Thousands of Euros |
|  | Balance at |  | Business |  |  |  |  |  |  |  | Translation |  | Balance at |
|  | 31/12/2016 |  | combination |  | Net charge |  | Cancellations |  | Reclassifications |  | differences |  | 31/12/2017 |
Non-current provisions |  | 5,118 |  | 23 |  | 422 |  | (23 | ) | 290 |  | (67 | ) | 5,763 |
|  | 5,118 |  | 23 |  | 422 |  | (23 | ) | 290 |  | (67 | ) | 5,763 |

Movement in provisions during 2018 is as follows:

|  | Thousands of Euros |
|  | Balance at |  |  |  |  |  |  |  | Translation |  | Balance at |
|  | 31/12/2017 |  | Net charge |  | Cancellations |  | Reclassifications |  | differences |  | 31/12/2018 |
Non-current provisions |  | 5,763 |  | 635 |  | (565 | ) | 277 |  | 4 |  | 6,114 |
|  | 5,763 |  | 635 |  | (565 | ) | 277 |  | 4 |  | 6,114 |

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Notes to the Consolidated Financial statements

(b) Current provisions

Movement in trade provisions during 2016 was as follows:

|  | Thousands of Euros |
|  | Balance at |  |  |  |  |  |  |  | Balance at |
|  | 31/12/2015 |  | Net charge |  | Cancellations |  | Translation differences |  | 31/12/2016 |
Trade provisions |  | 123,049 |  | (28,481 | ) | (6,417 | ) | 1,437 |  | 89,588 |
|  | 123,049 |  | (28,481 | ) | (6,417 | ) | 1,437 |  | 89,588 |

Movement in trade provisions during 2017 was as follows:

|  | Thousands of Euros |
|  | Balance at |  | Business |  |  |  |  |  |  |  | Translation |  | Balance at |
|  | 31/12/2016 |  | Combination |  | Net charge |  | Cancellations |  | Reclassification |  | differences |  | 31/12/2017 |
Trade provisions |  | 89,588 |  | 41,841 |  | (4,812 | ) | (2,886 | ) | (2,600 | ) | (14,136 | ) | 106,995 |
|  | 89,588 |  | 41,841 |  | (4,812 | ) | (2,886 | ) | (2,600 | ) | (14,136 | ) | 106,995 |

Movement in trade provisions during 2018 is as follows:

|  | Thousands of Euros |
|  | Balance at |  |  |  |  |  |  |  | Balance at |
|  | 31/12/2017 |  | Net charge |  | Cancellations |  | Translation differences |  | 31/12/2018 |
Trade provisions |  | 106,995 |  | (30,668 | ) | (290 | ) | 4,018 |  | 80,055 |
|  | 106,995 |  | (30,668 | ) | (290 | ) | 4,018 |  | 80,055 |

(20) Financial Liabilities

This note provides information on the contractual conditions of the Group’s financial liabilities, which are measured at amortized cost. For further information on exposure to interest rate risk, currency risk and liquidity risk and the fair values of financial liabilities, please refer to note 30.

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Notes to the Consolidated Financial statements

Details at 31 December 2018 and 2017 are as follows:

|  | Thousands of Euros |
Financial liabilities |  | 31/12/2018 |  | 31/12/2017 |
Non-current obligations (a) |  | 1,000,000 |  | 853,667 |
Senior secured debt (b) |  | 4,771,285 |  | 4,849,882 |
Other loans (b) |  | 239,686 |  | 169,214 |
Finance lease liabilities (c) |  | 9,537 |  | 5,415 |
Other non-current financial liabilities (e) |  | 78,955 |  | 23,637 |
Total non-current financial liabilities |  | 6,099,463 |  | 5,901,815 |
Current obligations (a) |  | 102,978 |  | 95,538 |
Senior secured debt (b) |  | 129,955 |  | 4,057 |
Other loans (b) |  | 24,839 |  | 29,527 |
Finance lease liabilities (c) |  | 3,348 |  | 3,945 |
Other current financial liabilities (e) |  | 16,262 |  | 22,003 |
Total current financial liabilities |  | 277,382 |  | 155,070 |

In September 2018, Grifols obtained a new non-current loan from the European Investment Bank totaling Euros 85,000 thousand that will be used by Grifols to support its investments in R&D, mainly focused on the search for new therapeutic indications for plasma-derived protein therapies. The financial terms include a fixed interest rate, a maturity of 10 years with a grace period of 2 years. At 31 December 2018, the carrying amount of the loans obtained from the European Investment Bank amounts to Euros 244,375 thousand (Euros 170,000 thousand at 31 December, 2017).

On 5 December 2017 the Group received a loan from the European Investment Bank totaling Euros 85 million, falling due in 10 years, at a fixed rate and with a grace period of 2 years. The loan will be used to support certain investments the Group’s R&D which are mainly focused on searching for new applications for plasmatic proteins.

On 28 October 2015, the Group received its first loan from the same entity and with the same terms for a total amount of Euros 100 million.

On 18 April 2017 the Group concluded the refinancing process of the Senior Unsecured Notes. The total note issuance amounted to Euros 1,000 million.

On 6 February 2017 the Group concluded the refinancing process of its senior debt. The total debt refinanced amounts to US Dollars 6,300 million (Euros 5,800 million), including the US Dollars 1,816 million loan obtained for the acquisition of Hologic’s transfusional diagnostics unit. Following the refinancing process, Grifols’ debt structure consisted of a US Dollars 6,000 million non-current loan from institutional investors and banks segmented in two tranches (Term Loan A and Term Loan B), and a US Dollars 300 million undrawn revolving credit facility.

Retrospectively as of 1 January 2018, Grifols has calculated the impact of the entry into force of the new IFRS 9 on the refinancing process of the Senior Unsecured Notes and the Senior debt, concluding that the refinancing of the notes caused a derecognition of the liability as they did not pass the new quantitative test, whereas the senior debt did not result in a derecognition of the liability.

According to the IASB’s interpretation published in October 2017, when a financial liability measured at amortized cost is modified or exchanged and does not result in the derecognition of the financial liability, a gain or loss should be recognized in profit or loss, calculated as the difference between the original contractual cash flows from the liability and the modified cash flows, discounted at the original effective interest rate of the liability. Due to the retrospective effect of IFRS 9, any gains or losses from the modification of financial liabilities that arise from applying the new standard in years prior to 1 January 2018 have been recognized in reserves, generating a positive net impact of Euros 24,636 thousand (see note 2 (c)).

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Notes to the Consolidated Financial statements

(a) Senior Unsecured Notes

On 18 April 2017, Grifols, S.A., issued US Dollars 1,000 million of Senior Unsecured Notes (the “Notes”) that will mature in 2025 and will bear annual interest at a rate of 3.20%. These notes replaced 97.1 % of the Senior Unsecured Notes issued in 2014 by Grifols Worldwide Operations Limited, a wholly-owned subsidiary of Grifols S.A., amounting to US Dollars 1,000 million, with a maturity in 2022 and with interest rate of 5.25% that was owned by a financial institution. The remaining 2.9% of the existing notes was redeemed before the exchange by an amount of Euros 26,618 thousand. The corresponding deferred costs of the notes have been recognized in profit and loss in 2017. On 2 May 2017 the Notes were admitted to listing on the Irish Stock Exchange.

Due to the implementation of IFRS 9, the refinancing of unsecured corporate notes has resulted in the decrease of liabilities by not passing the new quantitative test (see note 2).

Details of movement in the Senior Unsecured Notes at 31 December 2017 are as follows:

|  | Thousands of Euros |
|  | Opening outstanding |  |  |  |  |  | Translation |  | Closing outstanding |
|  | balance 01/01/17 |  | Refinancing |  | Repayments |  | differences |  | balance 31/12/17 |
Senior Unsecured Notes (nominal amount) |  | 948,677 |  | 108,597 |  | (26,618 | ) | (30,656 | ) | 1,000,000 |
Total |  | 948,677 |  | 108,597 |  | (26,618 | ) | (30,656 | ) | 1,000,000 |

At 31 December 2018 and 2017 the current obligations caption includes the issue of bearer promissory notes to Group employees, as follows:

|  | 31/12/2017 |
|  |  |  |  |  |  |  |  |  | Promissory |  |  |  | Interest |
|  |  |  |  |  | Nominal amount |  |  |  | notes subscribed |  | Buy back |  | pending accrual |
|  |  |  | Maturity |  | of promissory |  | Interest |  | (Thousands of |  | (Thousands of |  | (Thousands of |
|  | Issue date |  | date |  | notes (Euros) |  | rate |  | Euros) |  | Euros) |  | Euros) |
Issue of bearer promissory notes |  | 05/05/17 |  | 04/05/18 |  | 3,000 |  | 3.00 | % | 92,109 |  | (906 | ) | (909 | )

|  | 31/12/2018 |
|  | Issue date |  | Maturity date |  | Nominal amount of promissory notes (Euros) |  | Interest rate |  | Promissory notes subscribed (Thousands of Euros) |  | Buy back (Thousands of Euros) |  | Interest pending accrual (Thousands of Euros) |
Issue of bearer promissory notes |  | 05/05/18 |  | 04/05/19 |  | 3,000 |  | 4.00 | % | 99,990 |  | (1,041 | ) | (1,304 | )

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Notes to the Consolidated Financial statements

(b) Loans and borrowings

Details of loans and borrowings at 31 December 2018 and 2017 are as follows:

|  |  |  |  |  |  |  |  |  | Thousands of Euros |
|  |  |  |  |  |  |  |  |  | 31/12/2018 |  | 31/12/2017 |
Credit |  | Currency |  | Interest rate |  | Date awarded |  | Maturity date |  | Amount extended |  | Carrying amount |  | Amount extended |  | Carrying amount |
Senior debt - Tranche A |  | US Dollars |  | Libor + 1.75% |  | 31/01/2017 |  | 31/01/2023 |  | 2,052,403 |  | 1,949,782 |  | 1,959,476 |  | 1,959,476 |
Senior debt - Tranche A |  | Euros |  | Euribor + 1.75% |  | 31/01/2017 |  | 31/01/2023 |  | 607,000 |  | 576,650 |  | 607,000 |  | 607,000 |
Senior debt - Tranche B |  | US Dollars |  | Libor + 2.25% |  | 31/01/2017 |  | 31/01/2025 |  | 2,620,087 |  | 2,548,035 |  | 2,501,459 |  | 2,457,684 |
Total senior debt |  |  |  |  |  |  |  |  |  | 5,279,490 |  | 5,074,467 |  | 5,067,935 |  | 5,024,160 |
EIB Loan |  | Euros |  | 2.40% |  | 20/11/2015 |  | 20/11/2025 |  | 100,000 |  | 63,750 |  | 100,000 |  | 74,375 |
EIB Loan |  | Euros |  | 2.02% |  | 22/12/2017 |  | 22/12/2027 |  | 85,000 |  | 85,000 |  | 85,000 |  | 85,000 |
EIB Loan |  | Euros |  | 2.15% |  | 25/09/2018 |  | 25/09/2028 |  | 85,000 |  | 85,000 |  | — |  | — |
Total EIB Loan |  |  |  |  |  |  |  |  |  | 270,000 |  | 233,750 |  | 185,000 |  | 159,375 |
Revolving Credit |  | US Dollars |  | Libor + 1.75% |  | 31/01/2017 |  | 31/01/2023 |  | 262,009 |  | — |  | 250,146 |  | — |
Total Revolving Credit |  |  |  |  |  |  |  |  |  | 262,009 |  | — |  | 250,146 |  | — |
Other non-current loans |  | Euros |  | Euribor- Euribor+2.30% |  | 25/03/2010 |  | 30/09/2024 |  | 26,680 |  | 5,936 |  | 33,180 |  | 9,839 |
Loan transaction costs |  |  |  |  |  |  |  |  |  | — |  | (303,182 | ) | — |  | (174,278 | )
Non-current loans and borrowings |  |  |  |  |  |  |  |  |  | 5,838,179 |  | 5,010,971 |  | 5,536,261 |  | 5,019,096 |

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Notes to the Consolidated Financial statements

|  |  |  |  |  |  |  |  |  | Thousands of Euros |
|  |  |  |  |  |  |  |  |  | 31/12/2018 |  | 31/12/2017 |
Credit |  | Currency |  | Interest rate |  | Date awarded |  | Maturity date |  | Amount extended |  | Carrying amount |  | Amount extended |  | Carrying amount |
Senior debt - Tranche A |  | US Dollars |  | Libor + 1.75% |  | 31/01/2017 |  | 31/01/2023 |  | (* | ) | 102,621 |  | (* | ) | — |
Senior debt - Tranche A |  | Euros |  | Euribor + 1.75% |  | 31/01/2017 |  | 31/01/2023 |  | (* | ) | 30,350 |  | (* | ) | — |
Senior debt - Tranche B |  | US Dollars |  | Libor + 2.25% |  | 31/01/2017 |  | 31/01/2025 |  | (* | ) | 26,201 |  | (* | ) | 25,015 |
Total senior debt |  |  |  |  |  |  |  |  |  | — |  | 159,172 |  | — |  | 25,015 |
EIB Loan |  | Euros |  | 2.40% |  | 20/11/2015 |  | 20/11/2025 |  | (* | ) | 10,625 |  | (* | ) | 10,625 |
Total EIB Loan |  |  |  |  |  |  |  |  |  | — |  | 10,625 |  | — |  | 10,625 |
Other current loans |  |  |  | 0,10% - 4,62% |  |  |  |  |  | 144,571 |  | 14,214 |  | 131,700 |  | 18,902 |
Loan transaction costs |  |  |  |  |  |  |  |  |  | — |  | (29,217 | ) | — |  | (20,958 | )
Current loans and borrowings |  |  |  |  |  |  |  |  |  | 144,571 |  | 154,794 |  | 131,700 |  | 33,584 |

(*) See amount granted under non-current debt

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Notes to the Consolidated Financial statements

Current loans and borrowings include accrued interest amounting to Euros 2,546 thousand at 31 December 2018 (Euros 1,713 thousand at 31 December 2017).

On 6 February 2017 the Group refinanced its Senior Secured Debt with the existing lenders and obtained the additional debt for the acquisition of Hologic by an amount of US Dollars 1,816 million. The new senior debt consisted of a Term Loan A (“TLA”), which amounted US Dollars 2,350 million and Euros 607 million with a 1.75% margin over Libor and Euribor respectively and maturity in 2023 and quasi-bullet amortization structure, and a Term Loan B (“TLB”) which amounted US Dollars 3,000 million with a 2.25% margin over Libor and maturity in 2025. The borrowers of the total debt are Grifols Worldwide Operations Limited and Grifols, S.A. for the Term Loan A and Grifols Worldwide Operations USA, Inc. for the Term Loan B.

The present value discounted from cash flows under the new agreement, including any fees paid and discounted using the original effective interest rate differed by less than 10% of the present value discounted from cash flows remaining in the original debt, whereby it is considered that the debt instrument has not been substantially modified.

The costs of refinancing the senior debt amounted to Euros 84.8 million. Based on an analysis of the quantitative and qualitative factors, the Group concluded that the renegotiation of the terms of the senior debt did not imply a derecognition of the liability. The difference between the amortized cost of the debt applying the new IFRS 9 is Euros 332,399 thousand less than its nominal amount.

The terms and conditions of the senior secured debt are as follows:

· Tranche A: six year loan divided into two tranches: US Tranche A and Tranche A in Euros.

· US Tranche A :

· Original principal amount of US Dollars 2,350 million.

· Applicable margin of 175 basis points (bp) linked to US Libor.

· Quasi-bullet amortization structure.

· Maturity in 2023.

· Tranche A in Euros :

· Original principal amount of Euros 607 million.

· Applicable margin of 175 basis ponts (bp) linked to Euribor.

· Quasi-bullet amortization structure.

· Maturity in 2023.

Details of Tranche A by maturity at 31 December 2018 are as follows:

|  | US Tranche A |  | Tranche A in Euros |
Maturity |  | Principal in thousands of US Dollars |  | Principal in thousands of Euros |  | Principal in thousands of Euros |
2019 |  | 117,500 |  | 102,621 |  | 30,350 |
2020 |  | 235,000 |  | 205,240 |  | 60,700 |
2021 |  | 235,000 |  | 205,240 |  | 60,700 |
2022 |  | 1,321,875 |  | 1,154,476 |  | 341,437 |
2023 |  | 440,625 |  | 384,826 |  | 113,813 |
Total |  | 2,350,000 |  | 2,052,403 |  | 607,000 |

· Tranche B: Senior Debt Loan repayable in eight years.

· US Tranche B :

· Original principal amount of US Dollars 3,000 million.

· Applicable margin of 225 basis points (bp) linked to US Libor.

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Notes to the Consolidated Financial statements

· Quasi-bullet amortization structure.

· Maturity in 2025.

Details of Tranche B by maturity at 31 December 2018 are as follows:

|  | US Tranche B |
|  |  |  | Principal in thousands |  | Principal in thousands |
Maturity |  | Currency |  | of US Dollars |  | of Euros |
2019 |  | US Dollars |  | 30,000 |  | 26,201 |
2020 |  | US Dollars |  | 30,000 |  | 26,201 |
2021 |  | US Dollars |  | 30,000 |  | 26,201 |
2022 |  | US Dollars |  | 30,000 |  | 26,201 |
2023 |  | US Dollars |  | 30,000 |  | 26,201 |
2024 |  | US Dollars |  | 30,000 |  | 26,201 |
2025 |  | US Dollars |  | 2,767,500 |  | 2,417,030 |
Total |  | US Dollars |  | 2,947,500 |  | 2,574,236 |

· US Dollars 300 million committed credit revolving facility: Amount maturing on 2023 and applicable margin of 175 basis points (bp) pegged to US Libor. At 31 December 2018 and 2017 no amount has been drawn down on this facility.

The issue of senior unsecured notes and senior secured debt is subject to compliance with a leverage ratio covenant. At 31 December 2018 the Group complies with this covenant.

Both the Senior Term Loans and the Revolving Loans are guaranteed by Grifols, S.A. and certain significant subsidiaries of Grifols, S.A. that together with Grifols, S.A. represent, in the aggregate, at least 80% of the consolidated assets and consolidated EBITDA of Grifols, S.A. and its subsidiaries.

The Notes have been issued by Grifols S.A. and are guaranteed on a senior unsecured basis by subsidiaries of Grifols, S.A. that are guarantors and co-borrower under the New Credit Facilities. The guarantors are Grifols Worldwide Operations Limited, Biomat USA, Inc., Grifols Biologicals Inc., Grifols Shared Services North America, Inc., Grifols Diagnostic Solutions Inc., Grifols Therapeutics, Inc., Instituto Grifols, S.A., Grifols Worldwide Operations USA, Inc and Grifols USA, Llc.

(c) Finance lease liabilities

Details of minimum payments and the present value of finance lease liabilities, by maturity date, are as follows:

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Notes to the Consolidated Financial statements

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
|  | Minimum |  |  |  |  |  | Minimum |  |  |  |  |
|  | payments |  | Interest |  | Present Value |  | payments |  | Interest |  | Present Value |
Maturity at: |  |  |  |  |  |  |  |  |  |  |  |  |
Less than one year |  | 3,576 |  | 228 |  | 3,348 |  | 4,305 |  | 360 |  | 3,945 |
Two years |  | 3,339 |  | 123 |  | 3,216 |  | 2,636 |  | 179 |  | 2,457 |
Three years |  | 2,606 |  | 82 |  | 2,524 |  | 1,461 |  | 88 |  | 1,373 |
Four years |  | 1,971 |  | 53 |  | 1,918 |  | 814 |  | 60 |  | 754 |
Five years |  | 1,578 |  | 32 |  | 1,546 |  | 369 |  | 42 |  | 327 |
More than five years |  | 351 |  | 18 |  | 333 |  | 550 |  | 46 |  | 504 |
Total |  | 13,421 |  | 536 |  | 12,885 |  | 10,135 |  | 775 |  | 9,360 |

(d) Credit rating

In December 2018 and December 2017 Moody’s Investors Service has confirmed the ‘Ba3’ corporate family rating, ‘Ba2’ rating to the senior secured bank debt and ‘B2’ rating to the unsecured notes that were used to refinance the existing debt structure. The outlook is confirmed as stable.

In December 2018 and December 2017 Standard & Poor’s has confirmed its ‘BB’ rating on Grifols and has assigned ‘BB+’ and ‘B+’ issue ratings to Grifols’ senior secured debt and senior unsecured notes that were used to refinance the existing debt structure. The outlook for the rating is stable.

(e) Other financial liabilities

At 31 December 2018 “other financial liabilities” include interest-free loans extended by governmental institutions amounting to Euros 16,559 thousand (Euros 20,306 thousand at 31 December 2017). The portion of the loans considered a grant and still to be taken to profit and loss amounts to Euros 696 thousand (Euros 812 thousand at 31 December 2017) (see note 18).

At 31 December 2017, “other current financial liabilities” included an amount of Euros 5,000 thousand related to the remaining call option extended by the Group and the shareholders of Progenika with maturity in 2018. This option was executed in June 2018.

At 31 December 2018 and 2017 “other current financial liabilities” also include approximately Euros 6,704 thousand and Euros 3,056 thousand, respectively, which have been collected directly from Spanish Social Security affiliated bodies and transferred to financial institutions (see note 13).

Details of the maturity of other financial liabilities are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Maturity at: |  |  |  |  |
Up to one year |  | 16,262 |  | 22,003 |
Two years |  | 21,460 |  | 10,818 |
Three years |  | 49,602 |  | 3,787 |
Four years |  | 2,916 |  | 2,794 |
Five years |  | 1,799 |  | 2,247 |
Over five years |  | 3,178 |  | 3,991 |
|  | 95,217 |  | 45,640 |

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Notes to the Consolidated Financial statements

(f) Changes in liabilities derived from financing activities

|  | Thousand of Euros |
|  |  |  | Senior Secured |  |  |  |  |  |  |
|  |  |  | debt & Other |  | Finance lease |  | Other financial |  |  |
|  | Obligations |  | loans |  | liabilities |  | liabilities |  | Total |
Book value at January 1, 2017 |  | 926,941 |  | 3,948,154 |  | 9,945 |  | 57,096 |  | 4,942,136 |
New financing |  | 1,092,109 |  | 5,666,300 |  | — |  | 8,661 |  | 6,767,070 |
Refunds |  | (1,003,104 | ) | (3,936,799 | ) | (780 | ) | (21,838 | ) | (4,962,521 | )
Bear of interests |  | 61,944 |  | 198,588 |  | 505 |  | 1,020 |  | 262,057 |
Other movements |  | (57,484 | ) | (84,917 | ) | — |  | — |  | (142,401 | )
Collection / Payment of interests |  | (44,432 | ) | (162,647 | ) | — |  | — |  | (207,079 | )
Business combination |  | — |  | — |  | — |  | 2,163 |  | 2,163 |
Foreign exchange differences |  | (26,769 | ) | (575,999 | ) | (310 | ) | (1,462 | ) | (604,540 | )
Balance at December 31, 2017 |  | 949,205 |  | 5,052,680 |  | 9,360 |  | 45,640 |  | 6,056,885 |
New financing |  | 99,990 |  | 85,000 |  | — |  | 6,789 |  | 191,779 |
Refunds |  | (92,244 | ) | (45,225 | ) | (1,001 | ) | (20,041 | ) | (158,511 | )
Bear of interests |  | 31,694 |  | 253,673 |  | 409 |  | 865 |  | 286,641 |
Other movements (note 2) |  | 146,333 |  | (141,998 | ) | — |  | — |  | 4,335 |
Collection / Payment of interests |  | (32,000 | ) | (193,146 | ) | — |  | — |  | (225,146 | )
Business combination |  | — |  | — |  | 4,007 |  | 57,816 |  | 61,823 |
Foreign exchange differences |  | — |  | 154,781 |  | 110 |  | 4,148 |  | 159,039 |
Balance at December 31, 2018 |  | 1,102,978 |  | 5,165,765 |  | 12,885 |  | 95,217 |  | 6,376,845 |

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Notes to the Consolidated Financial statements

(21) Trade and Other Payables

Details are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Suppliers |  | 561,883 |  | 423,096 |
VAT payable |  | 8,954 |  | 8,827 |
Taxation authorities, withholdings payable |  | 26,299 |  | 24,084 |
Social security payable |  | 12,787 |  | 11,741 |
Other public entities |  | 111,776 |  | 97,068 |
Other payables |  | 159,816 |  | 141,720 |
Current income tax liabilities |  | 1,917 |  | 6,709 |
|  | 723,616 |  | 571,525 |

Suppliers

Details of balances with related parties are shown in note 31.

The Group’s exposure to currency risk and liquidity risk associated with trade and other payables is described in note 30.

(22) Other Current Liabilities

Details at 31 December are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Salaries payable |  | 153,160 |  | 129,519 |
Other payables |  | 504 |  | 649 |
Deferred income |  | 8,912 |  | 4,284 |
Advances received |  | 6,613 |  | 9,945 |
Other current liabilities |  | 169,189 |  | 144,397 |

(23) Net Revenues

Net revenues are mainly generated from the sale of goods.

The distribution of net consolidated revenues for 2018, 2017 and 2016 by segment is as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Bioscience |  | 3,516,704 |  | 3,429,785 |  | 3,195,424 |
Diagnostic |  | 702,265 |  | 732,369 |  | 691,701 |
Hospital |  | 119,454 |  | 105,649 |  | 102,251 |
Bio supplies |  | 167,004 |  | 66,791 |  | 57,239 |
Others |  | 22,451 |  | 18,263 |  | 34,601 |
Intersegments |  | (41,154 | ) | (34,784 | ) | (31,386 | )
|  | 4,486,724 |  | 4,318,073 |  | 4,049,830 |

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Notes to the Consolidated Financial statements

As a result of the creation of Bio Supplies segment and the Intersegments in 2017, the Group has reviewed the allocation of balances and transactions by segments. The comparative figures for 2016 have been restated accordingly.

The geographical distribution of net consolidated revenues is as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
USA and Canada |  | 2,974,429 |  | 2,896,505 |  | 2,707,579 |
Spain |  | 264,913 |  | 242,894 |  | 225,273 |
European Union |  | 535,361 |  | 444,089 |  | 426,223 |
Rest of the world |  | 712,021 |  | 734,585 |  | 690,755 |
Consolidated |  | 4,486,724 |  | 4,318,073 |  | 4,049,830 |

Details of discounts and other reductions in gross income are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Gross sales |  | 5,588,257 |  | 5,322,618 |  | 4,882,615 |
Chargebacks |  | (923,023 | ) | (826,775 | ) | (652,564 | )
Cash discounts |  | (62,518 | ) | (57,512 | ) | (51,953 | )
Volume rebates |  | (46,922 | ) | (43,274 | ) | (51,242 | )
Medicare and Medicaid |  | (40,343 | ) | (41,722 | ) | (47,820 | )
Other discounts |  | (28,727 | ) | (35,262 | ) | (29,206 | )
Net sales |  | 4,486,724 |  | 4,318,073 |  | 4,049,830 |

Movement in discounts and other reductions in gross income during 2016 were as follows:

|  | Thousands of Euros |
|  |  |  | Cash |  | Volume |  | Medicare / |  | Other |  |  |
|  | Chargebacks |  | discounts |  | rebates |  | Medicaid |  | discounts |  | Total |
Balance at 31 December 2015 |  | 126,178 |  | 5,902 |  | 29,680 |  | 12,468 |  | 5,367 |  | 179,595 |
Current estimate related to sales made in current and prior year |  | 652,564 |  | 51,953 |  | 51,242 |  | 47,820 |  | 29,206 |  | 832,785 | (1)
(Actual returns or credits in current period related to sales made in current period) |  | (693,458 | ) | (51,733 | ) | (27,409 | ) | (24,988 | ) | (27,243 | ) | (824,831 | )(2)
(Actual returns or credits in current period related to sales made in prior periods) |  | — |  | (248 | ) | (27,732 | ) | (14,401 | ) | (2,986 | ) | (45,367 | )(3)
Translation differences |  | 1,965 |  | 758 |  | 726 |  | 858 |  | 98 |  | 4,405 |
Balance at 31 December 2016 |  | 87,249 |  | 6,632 |  | 26,507 |  | 21,757 |  | 4,442 |  | 146,587 |

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Notes to the Consolidated Financial statements

Movement in discounts and other reductions to gross income during 2017 were as follows:

|  | Thousands of Euros |
|  |  |  | Cash |  | Volume |  | Medicare / |  | Other |  |  |
|  | Chargebacks |  | discounts |  | rebates |  | Medicaid |  | discounts |  | Total |
Balance at 31 December 2016 |  | 87,249 |  | 6,632 |  | 26,507 |  | 21,757 |  | 4,442 |  | 146,587 |
Current estimate related to sales made in current and prior year |  | 826,775 |  | 57,512 |  | 43,274 |  | 41,722 |  | 35,262 |  | 1,004,545 | (1)
(Actual returns or credits in current period related to sales made in current period) |  | (795,449 | ) | (52,270 | ) | (28,976 | ) | (28,198 | ) | (26,072 | ) | (930,965 | )(2)
(Actual returns or credits in current period related to sales made in prior periods) |  | 31 |  | (6,024 | ) | (20,210 | ) | (16,659 | ) | (2,864 | ) | (45,726 | )(3)
Translation differences |  | (12,716 | ) | (736 | ) | (2,604 | ) | (2,418 | ) | (625 | ) | (19,099 | )
Balance at 31 December 2017 |  | 105,890 |  | 5,114 |  | 17,991 |  | 16,204 |  | 10,143 |  | 155,342 |

Movement in discounts and other reductions to gross income during 2018 were as follows:

|  | Thousands of Euros |
|  |  |  | Cash |  | Volume |  | Medicare / |  | Other |  |  |
|  | Chargebacks |  | discounts |  | rebates |  | Medicaid |  | discounts |  | Total |
Balance at 31 December 2017 |  | 105,890 |  | 5,114 |  | 17,991 |  | 16,204 |  | 10,143 |  | 155,342 |
Current estimate related to sales made in current and prior year |  | 923,023 |  | 62,518 |  | 46,922 |  | 40,343 |  | 28,727 |  | 1,101,533 | (1)
(Actual returns or credits in current period related to sales made in current period) |  | (957,695 | ) | (56,568 | ) | (24,648 | ) | (21,324 | ) | (26,493 | ) | (1,086,728 | )(2)
(Actual returns or credits in current period related to sales made in prior periods) |  | — |  | (4,909 | ) | (16,384 | ) | (13,232 | ) | (3,781 | ) | (38,306 | )(3)
Translation differences |  | 3,957 |  | 286 |  | 916 |  | 950 |  | 241 |  | 6,350 |
Balance at 31 December 2018 |  | 75,175 |  | 6,441 |  | 24,797 |  | 22,941 |  | 8,837 |  | 138,191 |

(l) Net impact in income statement: estimate for the current year plus prior years’ adjustments. Adjustments made during the year corresponding to prior years’ estimates have not been significant.

(2) Amounts credited and posted against provisions for current period

(3) Amounts credited and posted against provisions for prior period

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Notes to the Consolidated Financial statements

(24) Personnel Expenses

Details of personnel expenses by function are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Cost of sales |  | 810,512 |  | 731,192 |  | 635,577 |
Research and development |  | 93,817 |  | 90,495 |  | 77,988 |
Selling, general & administration expenses |  | 345,224 |  | 323,880 |  | 314,348 |
|  | 1,249,553 |  | 1,145,567 |  | 1,027,913 |

Details by nature are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Wages and salaries |  | 1,000,682 |  | 917,810 |  | 822,384 |
Contributions to pension plans (see note 29) |  | 21,363 |  | 20,347 |  | 18,486 |
Other social charges |  | 29,055 |  | 27,679 |  | 25,074 |
Social Security |  | 198,453 |  | 179,731 |  | 161,969 |
|  | 1,249,553 |  | 1,145,567 |  | 1,027,913 |

(25) Expenses by Nature

(a) Amortization and depreciation

Expenses for the amortization and depreciation of intangible assets and property, plant and equipment, incurred during 2018, 2017 and 2016 classified by functions are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Cost of sales |  | 146,530 |  | 135,186 |  | 126,998 |
Research and development |  | 19,836 |  | 14,721 |  | 13,050 |
Selling, general & administration expenses |  | 62,243 |  | 65,583 |  | 61,821 |
|  | 228,609 |  | 215,490 |  | 201,869 |

(b) Other operating income and expenses

Other operating income and expenses incurred during 2018, 2017 and 2016 by function are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Cost of sales |  | 432,803 |  | 416,020 |  | 454,097 |
Research and development |  | 152,670 |  | 129,579 |  | 113,078 |
Selling, general & administration expenses |  | 410,753 |  | 460,959 |  | 393,523 |
|  | 996,226 |  | 1,006,558 |  | 960,698 |

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Notes to the Consolidated Financial statements

Details by nature are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Changes in trade provisions |  | (23,125 | ) | 3,648 |  | (22,069 | )
Professional services |  | 211,305 |  | 211,579 |  | 190,003 |
Commissions |  | 21,941 |  | 18,473 |  | 20,147 |
Supplies and auxiliary materials |  | 149,831 |  | 131,932 |  | 119,014 |
Operating leases (note 28) |  | 84,299 |  | 80,136 |  | 74,945 |
Freight |  | 112,340 |  | 105,292 |  | 96,680 |
Repair and maintenance expenses |  | 107,806 |  | 103,518 |  | 89,797 |
Advertising |  | 44,659 |  | 49,893 |  | 51,233 |
Insurance |  | 22,632 |  | 21,529 |  | 20,008 |
Royalties |  | 10,726 |  | 11,241 |  | 9,217 |
Travel expenses |  | 51,428 |  | 58,171 |  | 53,239 |
External services |  | 53,391 |  | 82,699 |  | 43,231 |
R&D Expenses |  | 100,889 |  | 89,977 |  | 78,379 |
Other |  | 48,104 |  | 38,470 |  | 136,874 |
Other operating income&expenses |  | 996,226 |  | 1,006,558 |  | 960,698 |

(26) Finance Result

Details are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Finance income |  | 13,995 |  | 9,678 |  | 9,934 |
Finance cost from Senior Unsecured Notes |  | (35,471 | ) | (65,189 | ) | (73,491 | )
Finance cost from senior debt |  | (247,646 | ) | (193,183 | ) | (168,332 | )
Finance cost from sale of receivables (note 13) |  | (6,053 | ) | (3,973 | ) | (4,885 | )
Capitalized interest |  | 8,955 |  | 8,839 |  | 13,019 |
Other finance costs |  | (13,058 | ) | (9,838 | ) | (11,140 | )
Finance costs |  | (293,273 | ) | (263,344 | ) | (244,829 | )
Change in fair value of financial derivatives (note 30) |  | — |  | (3,752 | ) | (7,610 | )
Impairment and gains / (losses) on disposal of financial instruments |  | 30,280 |  | (18,844 | ) | — |
Exchange differences |  | (8,246 | ) | (11,472 | ) | 8,916 |
Finance result |  | (257,244 | ) | (287,734 | ) | (233,589 | )

On 29 January 2018 (prior to the date on which the 2017 consolidated Financial statements were authorized to issue) Aradigm communicated that it had not obtained the approval of the Antimicrobial Drugs Advisory Committee of the US Food and Drug Administration for LinahiqTM. As a result, the financial assets related to the convertible note of Aradigm have been totally impaired totaling Euros 14,477 thousand at 31 December 2017. This amount was recognized in “Impairment and gains/(losses) on disposal of financial instruments” in the consolidated statement of profit and loss.

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Notes to the Consolidated Financial statements

During 2018 the Group has capitalized interest at a rate of between 4.61% and 5.18% based on the financing received (between 4.26% and 4.87% during 2017) (see note 4 (f)).

(27) Taxation

Grifols, S.A. is authorized to file consolidated tax returns in Spain with Diagnostic Grifols, S.A., Grifols Movaco, S.A., Laboratorios Grifols, S.A., Instituto Grifols, S.A., Grifols Worldwide Operations Spain, S.A. (formerly Logister, S.A), Biomat, S.A., Grifols Viajes, S.A., Grifols International, S.A., Grifols Engineering, S.A., Gri-Cel, S.A., Gripdan Invest, S.L. and VCN Biosciences, S.L. Grifols, S.A., in its capacity as Parent, is responsible for the filing and settlement of the consolidated tax return. Under prevailing tax law, Spanish companies pay 25% tax, which may be reduced by certain deductions.

The North American company Grifols Shared Services North America, Inc. is also authorized to file consolidated tax returns in the USA with Grifols Biologicals Inc., Grifols USA, LLC., Biomat USA, Inc., Grifols Therapeutics Inc. and Talecris Plasma Resources, Inc. The profits of the companies domiciled in the USA, determined in accordance with prevailing tax legislation, are subject to tax of approximately 22.4% of taxable income, which may be reduced by certain deductions.

(a) Reconciliation of accounting and taxable income

Details of the income tax expense and income tax related to profit for the year are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Profit before income tax from continuing operations |  | 725,842 |  | 695,722 |  | 712,752 |
Tax at 25% |  | 181,461 |  | 173,931 |  | 178,188 |
Permanent differences |  | (2,000 | ) | 17,163 |  | 8,019 |
Effect of different tax rates |  | (29,543 | ) | 40,981 |  | 14,509 |
Tax credits (deductions) |  | (18,226 | ) | (16,092 | ) | (20,163 | )
Impact related to the US tax legistation modifications |  | — |  | (171,169 | ) | — |
Prior year income tax expense |  | 381 |  | (8,614 | ) | 928 |
Other income tax expenses/(income) |  | (637 | ) | (1,792 | ) | (13,272 | )
Total income tax expense |  | 131,436 |  | 34,408 |  | 168,209 |
Deferred tax |  | (21,189 | ) | (149,444 | ) | (40,161 | )
Current tax |  | 152,625 |  | 183,851 |  | 208,370 |
Total income tax expense |  | 131,436 |  | 34,407 |  | 168,209 |

The effect of the different tax rates is basically due to a change of country mix in profits

On 22 December 2017, a tax reform was approved in the United States that took effect on 1 January 2018.

The Group carried out an exercise to identify changes in the tax reform affecting its subsidiaries in the USA and an assessment of the impact that these changes will have on the manner in which the deferred taxes will revert as of 31 December 2017. In the analysis performed, the main impact comes from the change in tax rates to be applied to deferred taxes as of 31 December 2017, which have fallen from a rate of 35% to 21% for fiscal years beginning on or after 1 January 2018. The impact recorded in the “income tax expense” caption amounted to Euros 171 million in 2017.

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Notes to the Consolidated Financial statements

(b) Deferred tax assets and liabilities

Details of deferred tax assets and liabilities are as follows:

|  | Thousands of Euros |
|  | Tax effect |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Assets |  |  |  |  |  |  |
Provisions |  | 7,936 |  | 4,564 |  | 3,696 |
Inventories |  | 41,029 |  | 35,619 |  | 39,297 |
Tax credits (deductions) |  | 57,357 |  | 49,467 |  | 37,685 |
Tax loss carryforwards |  | 32,769 |  | 6,179 |  | 10,717 |
Other |  | 8,611 |  | 7,513 |  | 3,393 |
Subtotal, assets |  | 147,702 |  | 103,342 |  | 94,788 |
Goodwill |  | (24,691 | ) | (22,346 | ) | (19,136 | )
Fixed assets, amortisation and depreciation |  | (3,922 | ) | (7,780 | ) | (7,062 | )
Intangible assets |  | (6,550 | ) | (7,059 | ) | (1,371 | )
Subtotal, net liabilities |  | (35,163 | ) | (37,185 | ) | (27,569 | )
Deferred assets, net |  | 112,539 |  | 66,157 |  | 67,219 |
Liabilities |  |  |  |  |  |  |
Goodwill |  | (150,644 | ) | (105,963 | ) | (131,039 | )
Intangible assets |  | (220,752 | ) | (201,921 | ) | (392,388 | )
Fixed assets |  | (99,819 | ) | (95,029 | ) | (158,060 | )
Debt cancellation costs |  | (42,319 | ) | (70,503 | ) | (64,762 | )
Inventories |  | — |  | — |  | (1,175 | )
Subtotal, liabilities |  | (513,534 | ) | (473,416 | ) | (747,424 | )
Tax loss carryforwards |  | 20,833 |  | 15,384 |  | 40,358 |
Provisions |  | 53,290 |  | 47,404 |  | 61,252 |
Inventories |  | 5,644 |  | 5,063 |  |  |
Other |  | 29,369 |  | 16,653 |  | 45,168 |
Subtotal, net assets |  | 109,135 |  | 84,504 |  | 146,778 |
Net deferred Liabilities |  | (404,398 | ) | (388,912 | ) | (600,646 | )

Movement in deferred tax assets and liabilities is as follows:

|  | Thousands of Euros |
Deferred tax assets and liabilities |  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Balance at 1 January |  | (322,755 | ) | (533,427 | ) | (564,771 | )
Movements during the year |  | 21,189 |  | 149,444 |  | 40,161 |
Movements in equity during the year |  | — |  | — |  | — |
Business combination (note 3) |  | 21,328 |  | 16,736 |  | — |
Translation differences |  | (11,621 | ) | 44,492 |  | (8,817 | )
Balance at 31 December |  | (291,859 | ) | (322,755 | ) | (533,427 | )

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Notes to the Consolidated Financial statements

The Spanish companies have opted to apply accelerated depreciation to certain additions to property, plant and equipment, which has resulted in the corresponding deferred tax liability.

The remaining assets and liabilities recognized in 2018, 2017 and 2016 were recognized in the statement of profit and loss.

Estimated net deferred tax assets to be reversed in a period of less than 12 months amount to Euros 27,097 thousand at 31 December 2018 (Euros 51,930 thousand at 31 December 2017).

The majority of the tax deductions pending application from Spanish companies related mainly to research and development, mature in 18 years.

Tax credits derived from the US companies are available for 20 years from their date of origin whilst tax credits from Spanish companies registered in the Basque Country are available for 15 years and other remaining Spanish companies have no maturity date.

The Group has not recognized as deferred tax assets the tax effect of the unused tax loss carryforwards of Group companies, which amount to Euros 55,282 thousand (Euros 51,169 thousand at 31 December 2017).

The commitments from Spanish companies from the reversal of deferred tax related to provisions of investments in subsidiaries are not significant.

(c) Years open to inspection

Under prevailing legislation, taxes cannot be considered to be definitively settled until the returns filed have been inspected by the taxation authorities, or the prescription period has elapsed.

The main tax audits currently open in the Group are as follows:

· Grifols Shared Services North America, Inc. and subsidiaries: notification of an inspection of State Income Tax in North Carolina and New York states (fiscal years 2012 to 2015). During 2017, this inspection was closed and the Group without any significant adjustment.

· Grifols Shared Services North America, Inc. and subsidiaries: In 2018 has been notified of an inspection related to the State Income Tax of the fiscal year 2016.

Group management does not expect any significant liability to derive from these inspections.

(28) Operating Leases

(a) Operating leases (as lessee)

At 31 December 2018, 2017 and 2016 the Group leases buildings and warehouses from third parties under operating leases.

Operating lease instalments of Euros 84,299 thousand were recognized as an expense in 2018 (Euros 80,136 thousand in 2017 and Euros 74,945 thousand in 2016) and fully comprise minimum lease payments.

Future minimum payments on non-cancellable operating leases at 31 December 2018, 2017 and 2016 are as follows:

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Notes to the Consolidated Financial statements

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Maturity at: |  |  |  |  |  |  |
Up to 1 year |  | 63,959 |  | 46,541 |  | 56,869 |
Between 1 and 5 years |  | 200,156 |  | 156,897 |  | 181,076 |
More than 5 years |  | 136,464 |  | 58,905 |  | 112,986 |
Total future minimum payments |  | 400,579 |  | 262,343 |  | 350,931 |

(b) Operating leases (as lessor)

At 31 December 2018, 2017 and 2016 the Group has no lease contracts as lessor.

(29) Other Commitments with Third Parties and Other Contingent Liabilities

(a) Guarantees

The Group has no significant guarantees extended to third parties.

(b) Guarantees committed with third parties

The Group has no significant guarantees extended to third parties, except for those described in note 20.

(c) Obligations with personnel

The Group’s annual contribution to defined contribution pension plans of Spanish Group companies for 2018 has amounted to Euros 777 thousand (Euros 725 thousand for 2017).

In successive years this contribution will be defined through labor negotiations.

In the event that control is taken of the Company, the Group has agreements with 69 employees/directors whereby they can unilaterally rescind their employment contracts with the Company and are entitled to termination benefits ranging from 2 to 5 years’ salary.

The Group has contracts with six executives entitling them to termination benefits ranging from one to four years of their salary in different circumstances.

Restricted Share Unit Retention Plan

For the annual bonus, the Group established a Restricted Share Unit Retention Plan (RSU Plan), for eligible employees. Under this plan, employees can choose to receive up to 50% of their yearly bonus in non-voting Class B ordinary shares (Grifols Class B Shares) or Grifols American Depositary Shares (Grifols ADS), and the Group will match this with an additional 50% of the employee’s choice of RSUs.

Grifols Class B Shares and Grifols ADS are valued at grant date.

These RSU’s will have a vesting period of 2 years and 1 day and, subsequently, the RSU’s will be exchanged for Grifols Class B Shares or Grifols ADS (American Depositary Share representing 1 Class B Share).

If an eligible employee leaves the Company or is terminated before the vesting period, he/she will not be entitled to the additional RSU’s.

At 31 December 2018, the Group has settled the RSU plan of 2015 for an amount of Euros 7,914 thousand.

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Notes to the Consolidated Financial statements

This commitment is treated as equity instrument and the amount totals Euros 12,652 thousand at 31 December 2018 (Euros 13,871 thousand at 31 December 2017).

Savings plan and profit-sharing plan

The Group has a defined contribution plan (savings plan), which qualifies as a deferred salary arrangement under Section 401 (k) of the Internal Revenue Code (IRC). Once eligible, employees may elect to contribute a portion of their salaries to the savings plan, subject to certain limitations. The Group matches 100% of the first 3% of employee contributions and 50% of the next 2%. Group and employee contributions are fully vested when contributed. The total cost of matching contributions to the savings plan was US Dollars 20.7 million for 2018 (US Dollars 18.9 million in 2017).

Other plans

The Group has a defined benefit pension plan for certain Talecris Biotherapeutics, GmbH employees in Germany as required by statutory law. The pension cost relating to this plan is not material for the periods presented.

(d) Purchase commitments

Details of the Group’s commitments at 31 December 2018 are as follows:

|  | Thousands of Euros |
2019 |  | 179,766 |
2020 |  | 166,163 |
2021 |  | 149,318 |
2022 |  | 4,143 |
2023 |  | 1,067 |
More than 5 years |  | 893 |

(e) Judicial procedures and arbitration

Details of legal proceedings in which the Company or Group companies are involved are as follows:

· bioMérieux, S.A., et ano. v. Hologic, Inc. et al., Case No. 1:17-cv-102 (M.D.N.C); Case No. 18-21-LPS-CJB (D. Del.): On 3 February 2017, bioMérieux, S.A and bioMérieux, Inc. filed suit against Hologic, Inc. (“Hologic”), Grifols, S.A. (“GSA”), and GDS in the U.S. District Court for the Middle District of North Carolina, alleging infringement of U.S. Patent Nos. 8,697,352 and 9,074,262 by virtue of defendants’ activities with respect to the Procleix HIV-1/HCV Assay®, Procleix Ultrio Assay®, and Procleix Ultrio Plus® products. Hologic and GDS filed a motion to dismiss for failure to state a claim on 3 April 2017. As a result of a claim of improper venue, the case was transferred to the U.S. District Court for the District of Delaware in early 2018. Hologic and GDS pursued defenses of failure to state a claim, non-infringement, invalidity, and that the infringement claims are contractually barred under a Non-Assertion Agreement. On 31 May 2018, Hologic, GDS and GSA filed a motion to sever and stay their contractual defense under the Non-Assertion Agreement pending resolution of the liability issues. Hologic and GDS filed a Motion to Dismiss for failure to state a claim and GSA filed a Motion to Dismiss for lack of personal jurisdiction. The Court denied Hologic’s and GDS’ Motions to Dismiss on 25 September 2018, and denied GSA’s Motion to Dismiss on 26 September 2018. On September 28, 2018, bioMérieux filed an amended complaint. Requests for Institution of Inter Parties Review were filed by Hologic with the Patent and Trademark Appeals Board on 12 February 2018, and were also denied. Requests for rehearing of the Patent and Trademark Appeals Decisions were filed on 10 September 2018 and 24 September 2018. Discovery has been initiated and is scheduled to be completed by 15 February 2019. Based on the amounts as of today’s date, the Group does not believe that the aforementioned litigation could result in a material impact on these financial statements.

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Notes to the Consolidated Financial statements

· Enzo Life Sciences, Inc. v. Hologic, Inc. et al., Case No. 1:16-cv-00894-LPS (D. Del.): On 4 October 2016, Enzo Life Sciences, Inc. (“Enzo”) filed suit against Hologic in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent No. 6,221,581 (the “‘581 Patent”) by virtue of Hologic’s activities with respect to Progensa®, Procleix®, and Aptima®products. On 9 November 2017, the Court granted Enzo’s motion to amend its complaint to add GSA and GDS as defendants with respect to the Procleix® products at issue. Hologic and GDS answered the complaint, alleging non-infringement and invalidity among their defenses. GSA filed a Motion to Dismiss for lack of personal jurisdiction, which was denied on 26 September 2018. A Request for Institution of Inter Parties Review was also filed by Hologic and denied by the Patent and Trademark Appeals Board on 18 April 2018. Trial was scheduled for September 2019. Fact discovery was nearly complete and depositions of key witnesses were scheduled. However, these activities were taken off calendar at the request of Enzo after issuance of the 15 October 2018 Court Order and Opinion on Claim Construction narrowing the scope of the ‘581 Patent claims such that the products at issue would not infringe the ‘581 Patent. On 5 November 2018, the Court entered final judgement in favor of Hologic, GSA and GDS following the filing of a Joint Stipulation of Noninfringement. Enzo intends to appeal the Court’s claim construction ruling. Based on the amounts as of today’s date, the Group does not believe that the aforementioned litigation could result in a material impact on these financial statements.

· Concerning the acquisition in 2014 of the transfusional Diagnostic unit and after an internal investigation by the Company, no abnormal commercial or contractual practices have been found.

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Notes to the Consolidated Financial statements

(30) Financial Instruments

Classification

Disclosure of financial instruments by nature, category and fair value is as follows:

|  | Thousand of Euros |
|  | 31/12/2017 |
|  | Carrying amount |  | Fair Value |
|  |  |  | Financial |  | Available for |  |  |  |  |  |  |  |  |  |  |  |  |
|  | Loans and |  | instruments |  | sale financial |  | Debts and |  |  |  |  |  |  |  |  |  |  |
|  | receivables |  | held for trading |  | assets |  | payables |  | Total |  | Level 1 |  | Level 2 |  | Level 3 |  | Total |
Non-current financial assets |  | — |  | — |  | 38,708 |  | — |  | 38,708 |  | 38,708 |  | — |  | — |  | 38,708 |
Financial derivatives |  | — |  | 8,338 |  | — |  | — |  | 8,338 |  | — |  | — |  | 8,338 |  | 8,338 |
Financial assets measured at fair value |  | — |  | 8,338 |  | 38,708 |  | — |  | 47,046 |  |  |  |  |  |  |  |  |
Non-current financial assets |  | 22,843 |  | — |  | — |  | — |  | 22,843 |  |  |  |  |  |  |  |  |
Other current financial assets |  | 10,738 |  | — |  | — |  | — |  | 10,738 |  |  |  |  |  |  |  |  |
Trade and other receivables |  | 304,864 |  | — |  | — |  | — |  | 304,864 |  |  |  |  |  |  |  |  |
Cash and cash equivalents |  | 886,521 |  | — |  | — |  | — |  | 886,521 |  |  |  |  |  |  |  |  |
Financial assets not measured at fair value |  | 1,224,966 |  | — |  | — |  | — |  | 1,224,966 |  |  |  |  |  |  |  |  |
Senior Unsecured Notes |  | — |  | — |  | — |  | (858,911 | ) | (858,911 | ) | (1,018,130 | ) | — |  | — |  | (1,018,130 | )
Promissory Notes |  | — |  | — |  | — |  | (90,294 | ) | (90,294 | ) |  |  |  |  |  |  |  |
Senior secured debt |  | — |  | — |  | — |  | (4,853,939 | ) | (4,853,939 | ) | — |  | (5,063,769 | ) | — |  | (5,063,769 | )
Other bank loans |  | — |  | — |  | — |  | (198,741 | ) | (198,741 | ) |  |  |  |  |  |  |  |
Finance lease payables |  | — |  | — |  | — |  | (9,360 | ) | (9,360 | ) |  |  |  |  |  |  |  |
Other financial liabilities |  | — |  | — |  | — |  | (45,640 | ) | (45,640 | ) |  |  |  |  |  |  |  |
Trade and other payables |  | — |  | — |  | — |  | (423,096 | ) | (423,096 | ) |  |  |  |  |  |  |  |
Other current liabilities |  | — |  | — |  | — |  | (14,879 | ) | (14,879 | ) |  |  |  |  |  |  |  |
Financial liabilities not measured at fair value |  | — |  | — |  | — |  | (6,494,860 | ) | (6,494,860 | ) |  |  |  |  |  |  |  |
|  | 1,224,966 |  | 8,338 |  | 38,708 |  | (6,494,860 | ) | (5,222,848 | ) |  |  |  |  |  |  |  |

The Group does not provide details of the fair value of certain financial instruments as their carrying amount is very similar to their fair value because of its short term.

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Notes to the Consolidated Financial statements

|  | Thousand of Euros |
|  | 31/12/2018 |
|  | Carrying amount |  | Fair Value |
|  | Financial assets |  | Financial |  | Financial |  | Other |  |  |  |  |  |  |  |  |  |  |
|  | at amortised |  | assets at |  | liabilities at |  | financial |  |  |  |  |  |  |  |  |  |  |
|  | costs |  | FVTPL |  | amortised costs |  | liabilities |  | Total |  | Level 1 |  | Level 2 |  | Level 3 |  | Total |
Non-current financial assets |  | — |  | 7 |  | — |  | — |  | 7 |  | 7 |  | — |  | — |  | 7 |
Current Financial derivatives |  | — |  | 19,934 |  | — |  | — |  | 19,934 |  | — |  | — |  | 19,934 |  | 19,934 |
Financial assets measured at fair value |  | — |  | 19,941 |  | — |  | — |  | 19,941 |  |  |  |  |  |  |  |  |
Non-current financial assets |  | 107,594 |  | — |  | — |  | — |  | 107,594 |  |  |  |  |  |  |  |  |
Other current financial assets |  | 34,031 |  | — |  | — |  | — |  | 34,031 |  |  |  |  |  |  |  |  |
Trade and other receivables |  | 361,585 |  | — |  | — |  | — |  | 361,585 |  |  |  |  |  |  |  |  |
Cash and cash equivalents |  | 1,033,792 |  | — |  | — |  | — |  | 1,033,792 |  |  |  |  |  |  |  |  |
Financial assets not measured at fair value |  | 1,537,002 |  | — |  | — |  | — |  | 1,537,002 |  |  |  |  |  |  |  |  |
Senior Unsecured Notes |  | — |  | — |  | (1,005,333 | ) | — |  | (1,005,333 | ) | (985,480 | ) | — |  | — |  | (985,480 | )
Promissory Notes |  | — |  | — |  | (97,645 | ) | — |  | (97,645 | ) |  |  |  |  |  |  |  |
Senior secured debt |  | — |  | — |  | (4,901,240 | ) | — |  | (4,901,240 | ) | — |  | (5,055,323 | ) | — |  | (5,055,323 | )
Other bank loans |  | — |  | — |  | (264,525 | ) | — |  | (264,525 | ) |  |  |  |  |  |  |  |
Finance lease payables |  | — |  | — |  | (12,885 | ) | — |  | (12,885 | ) |  |  |  |  |  |  |  |
Other financial liabilities |  | — |  | — |  | (95,217 | ) | — |  | (95,217 | ) |  |  |  |  |  |  |  |
Debts with associates |  | — |  | — |  | (7,079 | ) | — |  | (7,079 | ) |  |  |  |  |  |  |  |
Other non-current debts |  | — |  | — |  | — |  | (1,301 | ) | (1,301 | ) |  |  |  |  |  |  |  |
Trade and other payables |  | — |  | — |  | — |  | (721,699 | ) | (721,699 | ) |  |  |  |  |  |  |  |
Other current liabilities |  | — |  | — |  | — |  | (169,189 | ) | (169,189 | ) |  |  |  |  |  |  |  |
Financial liabilities not measured at fair value |  | — |  | — |  | (6,383,924 | ) | (892,189 | ) | (7,276,113 | ) |  |  |  |  |  |  |  |
|  | 1,537,002 |  | 19,941 |  | (6,383,924 | ) | (892,189 | ) | (5,719,170 | ) |  |  |  |  |  |  |  |

The Group does not provide details of the fair value of certain financial instruments as their carrying amount is very similar to their fair value because of its short term.

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Notes to the Consolidated Financial statements

Financial derivatives

At 31 December 2018 and 2017 the Group has recognized the following derivatives:

|  |  |  | Notional |  | Notional |  | Thousands of Euros |  |  |
|  |  |  | amount at |  | amount at |  | Value at |  | Value at |  |  |
Financial derivatives |  | Currency |  | 31/12/2018 |  | 31/12/2017 |  | 31/12/18 |  | 31/12/17 |  | Maturity |
Call Option (Interstate Blood Bank, Inc., Bio-Blood Components, Inc and Plasma Biological Services, LLC) |  | US Dollar |  | N/A |  | N/A |  | 8,733 |  | 8,338 |  | 30/04/2019 |
Call Option (ADMA Centers) |  | US Dollar |  | N/A |  | N/A |  | 11,201 |  | — |  | 01/01/2019 |
Total Assets |  |  |  |  |  |  |  | 19,934 |  | 8,338 |  |  |

On 11 May 2016 the Group paid an aggregate amount equal to US Dollars 10,000 thousand (Euros 8,960 thousand at the exchange rate at the date of acquisition) in respect of the call option for the Interstate Blood Bank, Inc. shares, Bio-Blood Components, Inc. shares and Plasma Biological Services, LLC. shares that are not owned by the Group. The call option can be exercised by the Group by delivering written notice of its intention at any time on or after 1 February 2019 and on or before 30 April 2019 (see note 11).

On 6 June 2017, Biotest Pharmaceuticals Corporation agreed to purchase from ADMA Biologics all of its rights, titles and interests in two donation centers located in Georgia, USA. On 1 August 2018, Grifols acquired Biotest and its net assets (including the purchase option). The execution of the purchase option was carried out on 1 January 2019.

Financial derivatives are valued based on generally accepted valuation techniques (level 3 in the fair value hierarchy), using to the greatest extent data from the market and to a lesser extent specific data of the Group.

Derivative financial instruments that do not meet the hedge accounting requirements are classified and measured as financial assets or financial liabilities at fair value through profit and loss.

Credit risk

(a) Exposure to credit risk

The carrying amount of financial assets represents the maximum exposure to credit risk. At 31 December 2018 and 2017 the maximum level of exposure to credit risk is as follows:

|  |  |  | Thousands of Euros |
Carrying amount |  | Note |  | 31/12/2018 |  | 31/12/2017 |
Non-current financial assets |  | 11 |  | 107,601 |  | 69,889 |
Other current financial assets |  | 11 |  | 53,965 |  | 10,738 |
Trade receivables |  | 13 |  | 269,167 |  | 286,198 |
Other receivables |  | 13 |  | 45,327 |  | 18,666 |
Cash and cash equivalents |  | 14 |  | 1,033,792 |  | 886,521 |
|  |  |  | 1,509,852 |  | 1,272,012 |

The maximum level of exposure to risk associated with receivables at 31 December 2018 and 2017, by geographical area, is as follows.

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|  | Thousands of Euros |
Carrying amount |  | 31/12/2018 |  | 31/12/2017 |
Spain |  | 46,025 |  | 63,505 |
EU countries |  | 48,354 |  | 53,403 |
United States of America |  | 79,829 |  | 65,068 |
Other European countries |  | 14,289 |  | 5,761 |
Other regions |  | 125,997 |  | 117,127 |
|  | 314,494 |  | 304,864 |

(b) Impairment losses

A breakdown of the trade receivables net of the bad debt provision by ageing as of 31 December 2017 is as follows:

|  | Thousands of Euros |
|  |  |  |  |  |  |  | Total net trade |
|  |  |  | Total gross carrying |  |  |  | receivable third |
|  | ECL Rate |  | amount |  | Provision |  | party |
Not matured |  | 0.19 | % | 224,476 |  | (35 | ) | 224,441 |
Past due 0-30 days |  | 0.19 | % | 41,145 |  | (7,476 | ) | 33,669 |
Past due 31-60 days |  | 0.62 | % | 12,904 |  | (3 | ) | 12,901 |
Past due 61-90 days |  | 2.03 | % | 715 |  | (8 | ) | 707 |
Past due 91-180 days |  | 3.01 | % | 4,293 |  | (35 | ) | 4,258 |
Past due 181-365 days |  | 8.52 | % | 7,468 |  | (2,110 | ) | 5,358 |
More than one year |  | 100.00 | % | 7,260 |  | (2,971 | ) | 4,289 |
Customers with objective evidence of impairment |  |  |  | 7,643 |  | (7,068 | ) | 575 |
|  |  |  | 305,904 |  | (19,706 | ) | 286,198 |

A breakdown of the trade receivables net of the bad debt provision by seniority as of December 31, 2018 is as follows:

|  | Thousands of Euros |
|  |  |  |  |  |  |  | Total net trade |
|  |  |  | Total gross |  |  |  | receivable |
|  | ECL Rate |  | carrying amount |  | Provision |  | third party |
Not matured |  | 0.19 | % | 180,448 |  | (335 | ) | 180,113 |
Past due 0-30 days |  | 0.19 | % | 52,310 |  | (92 | ) | 52,218 |
Past due 31-60 days |  | 0.62 | % | 11,125 |  | (67 | ) | 11,058 |
Past due 61-90 days |  | 2.03 | % | 10,729 |  | (208 | ) | 10,521 |
Past due 91-180 days |  | 3.01 | % | 12,158 |  | (353 | ) | 11,805 |
Past due 181-365 days |  | 8.52 | % | 4,158 |  | (1,222 | ) | 2,936 |
More than one year |  | 100.00 | % | 7,549 |  | (7,033 | ) | 516 |
Customers with objective evidence of impairment |  |  |  | 11,221 |  | (11,221 | ) | — |
|  |  |  | 289,698 |  | (20,531 | ) | 269,167 |

Unimpaired receivables that are past due mainly relate to public entities.

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Notes to the Consolidated Financial statements

Movement in the bad debt provision was as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
Opening balance |  | 19,706 |  | 17,987 |  | 13,210 |
Net charges for the year |  | 6,443 |  | 8,003 |  | 6,411 |
Net cancellations for the year |  | (5,650 | ) | (4,732 | ) | (2,217 | )
Translation differences |  | 32 |  | (1,552 | ) | 583 |
Closing balance |  | 20,531 |  | 19,706 |  | 17,987 |

An analysis of the concentration of credit risk is provided in note 5 (a).

Liquidity risk

The management of the liquidity risk is explained in note 5.

Details of the contractual maturity dates of financial liabilities including committed interest calculated using interest rate forward curves are as follows:

|  |  |  | Thousands of Euros |
|  |  |  | Carrying |  |  |  |  |  |  |  |  |  |  |  |  |
|  |  |  | amount at |  | Contractual |  | 6 months |  | 6 - 12 |  | 1-2 |  | 2- 5 |  | More than |
Carrying amount |  | Note |  | 31/12/17 |  | flows |  | or less |  | months |  | years |  | years |  | 5 years |
Financial liabilities |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Bank loans |  | 20 |  | 5,052,680 |  | 6,138,673 |  | 105,584 |  | 106,492 |  | 322,421 |  | 3,115,887 |  | 2,488,289 |
Other financial liabilities |  | 20 |  | 45,640 |  | 45,642 |  | 19,393 |  | 2,610 |  | 10,758 |  | 10,497 |  | 2,384 |
Bonds and other marketable securities |  | 20 |  | 949,205 |  | 1,331,203 |  | 107,203 |  | 16,000 |  | 32,000 |  | 128,000 |  | 1,048,000 |
Finance lease payables |  | 20 |  | 9,360 |  | 10,136 |  | 2,192 |  | 2,113 |  | 2,602 |  | 2,790 |  | 439 |
Payable to suppliers |  | 21 |  | 423,096 |  | 423,096 |  | 423,020 |  | 76 |  | — |  | — |  | — |
Other current liabilities |  | 22 |  | 14,878 |  | 14,878 |  | 14,462 |  | 416 |  | — |  | — |  | — |
Total |  |  |  | 6,494,859 |  | 7,963,628 |  | 671,854 |  | 127,707 |  | 367,781 |  | 3,257,174 |  | 3,539,112 |

|  |  |  | Thousands of Euros |
|  |  |  | Carrying |  |  |  |  |  |  |  |  |  |  |  |  |
|  |  |  | amount at |  | Contractual |  | 6 months |  | 6 - 12 |  | 1-2 |  | 2- 5 |  | More than |
Carrying amount |  | Note |  | 31/12/18 |  | flows |  | or less |  | months |  | years |  | years |  | 5 years |
Financial liabilities |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Bank loans |  | 20 |  | 5,165,765 |  | 6,522,083 |  | 195,568 |  | 202,437 |  | 522,040 |  | 3,086,734 |  | 2,515,304 |
Other financial liabilities |  | 20 |  | 95,217 |  | 95,218 |  | 14,167 |  | 2,095 |  | 21,324 |  | 55,863 |  | 1,769 |
Bonds and other marketable securities |  | 20 |  | 1,102,978 |  | 1,305,645 |  | 113,645 |  | 16,000 |  | 32,000 |  | 128,000 |  | 1,016,000 |
Finance lease payables |  | 20 |  | 12,885 |  | 13,423 |  | 1,946 |  | 1,630 |  | 3,367 |  | 5,655 |  | 825 |
Debts with associates |  | 31 |  | 7,079 |  | 7,079 |  | — |  | 7,079 |  | — |  | — |  | — |
Payable to suppliers |  | 21 |  | 561,883 |  | 561,884 |  | 561,559 |  | 325 |  | — |  | — |  | — |
Other current liabilities |  | 22 |  | 16,029 |  | 16,028 |  | 15,861 |  | 167 |  | — |  | — |  | — |
Total |  |  |  | 6,961,836 |  | 8,521,360 |  | 902,746 |  | 229,733 |  | 578,731 |  | 3,276,252 |  | 3,533,898 |

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Notes to the Consolidated Financial statements

Currency risk

The Group’s exposure to currency risk is as follows:

|  | Thousands of Euros |
|  | 31/12/2017 |
|  | Euros (*) |  | Dollars (**) |
Trade receivables |  | 3,596 |  | 22,936 |
Receivables from Group companies |  | 103,338 |  | 7,619 |
Loans to Group companies |  | 34,140 |  | 91,566 |
Cash and cash equivalents |  | 63,981 |  | 2,172 |
Trade payables |  | (14,213 | ) | (3,582 | )
Payables to Group companies |  | (42,296 | ) | (11,241 | )
Loans from Group companies |  | (22,913 | ) | (3,953 | )
Bank loans |  | (85,000 | ) | — |
Balance sheet exposure |  | 40,633 |  | 105,517 |

(*) Balances in Euros in subsidiaries with US Dollars functional currency

(**) Balances in US Dollars in subsidiaries with Euros functional currency

|  | Thousands of Euros |
|  | 31/12/2018 |
|  | Euros (*) |  | Dollars (**) |
Trade receivables |  | 2,691 |  | 45,801 |
Receivables from Group companies |  | 54,903 |  | 6,291 |
Loans to Group companies |  | 40,387 |  | 4,343 |
Cash and cash equivalents |  | 120,281 |  | 1,296 |
Trade payables |  | (13,354 | ) | (6,113 | )
Payables to Group companies |  | (60,363 | ) | (63,932 | )
Loans from Group companies |  | (94,771 | ) | (4,336 | )
Bank loans |  | (74,375 | ) | — |
Balance sheet exposure |  | (24,601 | ) | (16,650 | )

(*) Balances in Euros in subsidiaries with US Dollars functional currency

(**) Balances in US Dollars in subsidiaries with Euros functional currency

The most significant exchange rates applied at 2018 and 2017 year ends are as follows:

|  | Closing exchange rate |
Euros |  | 31/12/2018 |  | 31/12/2017 |
US Dollars |  | 1.1450 |  | 1.1993 |

A sensitivity analysis for foreign exchange fluctuations is as follows:

Had the US Dollar strengthened by 10% against the Euro at 31 December 2018, equity would have increased by Euros 506,131 thousand (Euros 416,116 thousand at 31 December 2017) and profit due to foreign exchange

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differences would have increased by Euros 4,125 thousand (Euros 14,615 thousand at 31 December 2017). This analysis assumes that all other variables are held constant, especially that interest rates remain constant. A 10% weakening of the US Dollar against the Euro at 31 December 2018 and 2017 would have had the opposite effect for the amounts shown above, all other variables being held constant.

Interest rate risk

(a) Interest-rate profile

To date, the profile of interest on interest-bearing financial instruments is as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Fixed-interest financial instruments |  |  |  |  |
Financial liabilities |  | (1,244,375 | ) | (1,170,000 | )
|  | (1,244,375 | ) | (1,170,000 | )
Variable-interest financial instruments |  |  |  |  |
Financial liabilities |  | (5,233,638 | ) | (5,049,382 | )
|  | (5,233,638 | ) | (5,049,382 | )
|  | (6,478,013 | ) | (6,219,382 | )

(b) Sensitivity analysis

If the interest rate had been 100 basis points higher during 2018, the interest expense would have increased by Euros 53,082 thousand.

If the interest rate had been 100 basis points higher during 2017, the interest expense would have increased by Euros 52,999 thousand. As the Group does not have any derivatives in place, the net effect on cash interest payments would have increased by the same amount.

(31) Balances and Transactions with Related Parties

Details of balances with related parties are as follows:

|  | Thousands of Euros |
|  | 31/12/2018 |  | 31/12/2017 |
Receivables from associates (note 13) |  | 382 |  | 3,219 |
Trade payables associates |  | (15,796 | ) | (4,583 | )
Loans to associates (note 11) |  | 50,304 |  | 26,654 |
Loans to other related parties (note 11) |  | 82,969 |  | — |
Debts with associates |  | (7,079 | ) | — |
Debts with key management personnel |  | (4,425 | ) | (6,164 | )
Payables to members of the board of directors |  | — |  | (463 | )
Payables to other related parties |  | (7,706 | ) | (9,187 | )
|  | 98,649 |  | 9,476 |

Payables are included in trade and other payables (see note 21).

(a) Group transactions with related parties

Group transactions with related parties during 2016 were as follows:

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|  | Thousands of Euros |
|  |  |  | Key management |  | Other related |  | Board of directors |
|  | Associates |  | personnel |  | parties |  | of the Company |
Net sales |  | 193 |  | — |  | — |  | — |
Purchases |  | (35,569 | ) | — |  | — |  | — |
Other service expenses |  | (7,591 | ) | — |  | (5,325 | ) | (905 | )
Operating lease expense |  | — |  | — |  | (5,281 | ) | — |
Remuneration |  | — |  | (10,287 | ) | — |  | (3,668 | )
R&D agreements |  | (10,188 | ) | — |  | — |  | — |
Finance result |  | 1,946 |  | — |  | — |  | — |
|  | (51,209 | ) | (10,287 | ) | (10,606 | ) | (4,573 | )

Group transactions with related parties during 2017 were as follows:

|  | Thousands of Euros |
|  |  |  | Key management |  | Other related |  | Board of directors |
|  | Associates |  | personnel |  | parties |  | of the Company |
Net sales |  | 3,009 |  | — |  | — |  | — |
Purchases |  | (68,335 | ) | — |  | — |  | — |
Other service expenses |  | (11,798 | ) | — |  | (7,100 | ) | (939 | )
Operating lease expense |  | — |  | — |  | (5,426 | ) | — |
Remuneration |  | — |  | (13,672 | ) | — |  | (5,755 | )
R&D agreements |  | (164 | ) | — |  | — |  | — |
Finance Result |  | 152 |  | — |  | — |  | — |
|  | (77,136 | ) | (13,672 | ) | (12,526 | ) | (6,694 | )

Group transactions with related parties during 2018 are as follows:

|  | Thousands of Euros |
|  |  |  | Key management |  | Other related |  | Board of directors |
|  | Associates |  | personnel |  | parties |  | of the Company |
Net sales |  | 5,846 |  | — |  | — |  | — |
Purchases |  | (97,941 | ) | — |  | — |  | — |
Other service expenses |  | (21,065 | ) | — |  | (4,282 | ) | (844 | )
Operating lease expense |  | — |  | — |  | (5,469 | ) | — |
Remuneration |  | — |  | (16,070 | ) | — |  | (5,848 | )
R&D agreements |  | (50 | ) | — |  | — |  | — |
Sale of investments (note 3) |  | — |  | — |  | 469,881 |  | — |
Finance result |  | 3,372 |  | — |  | — |  | — |
|  | (109,838 | ) | (16,070 | ) | 460,130 |  | (6,692 | )

Every year the Group contributes 0.7% of its profits before tax to a non-profit organization.

“Other service expenses” include contributions to non-profit organizations totaling Euros 4,282 thousand in 2018 (Euros 7,100 thousand in 2017 and Euros 5,325 thousand in 2016).

During 2011 one of the Company’s directors signed a three-year consulting services contract. The director received annual fees of US Dollars 1 million for these services and an additional bonus of US Dollars 2 million for complying with certain conditions. In the years 2014, 2015, 2017 and 2018 the contract has been

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Notes to the Consolidated Financial statements

renewed, the amount of the fees corresponds to US Dollars 1 million per year. The contract has an expiration date of 31 March 2019.

On 28 December 2018, the Group sold Biotest and Haema to Scranton Enterprises B.V (shareholder of Grifols) for US Dollars 538,014 thousand (see note 3). For the payment of the mentioned amount of the sale, Scranton signed a loan contract dated 28 December 2018 for an amount of US Dollars 95,000 thousand (Euros 82,969 thousand) with Grifols Worldwide Operations Limited. The compensation is 2%+EURIBOR and due on 28 December 2025.

Directors representing shareholders´ interests have received remuneration of Euros 1,640 thousand in 2018 (Euros 1,881 thousand in 2017).

The Group has not extended any advances or loans to the members of the board of directors or key management personnel nor has it assumed any guarantee commitments on their behalf. It has also not assumed any pension or life insurance obligations on behalf of former or current members of the board of directors or key management personnel. In addition, certain Company directors and key management personnel have termination benefit commitments (see note 29 (c)).

(b) Conflicts of interest concerning the directors

The Company’s directors and their related parties have not entered into any conflict of interest that should have been reported in accordance with article 229 of the revised Spanish Companies Act.

(32) Subsequent events

Acquisition of ownership interest in Shanghai RAAS

Grifols reported in November 2018 that it had started conversations with Shanghai RAAS Blood Products Co Ltd. (“SR”) in order to make an investment in this company, which is listed in Shenzhen Stock Exchange (People’s Republic of China). On March 7, 2019 Grifols and SR signed an agreement for asset purchase by share issue, according to which:

· Grifols will acquire 26.2% voting and economic rights in SR. Grifols will contribute 45% economic rights and 40% voting rights in its subsidiary Grifols Diagnostic Solutions Inc. that is wholly owned by Grifols and, therefore, Grifols, S.A will continue to hold 55% economic rights and 60% voting rights in Grifols Diagnostic Solutions Inc.

After the consummation of the transaction, the main shareholders in SR will be Creat Group Co. Ltd. (“Creat”), (ca. 26.7%), Grifols (ca. 26.2%) and RAAS China Limited (ca. 25.8%). Other minority and institutional investors will hold the remaining shares.

· Grifols will have the right to appoint three directors in SR and SR will have the right to appoint one director in Grifols Diagnostic Solutions Inc.

· Grifols will have a veto right on certain decisions such as issue of shares, disposal of assets, mergers and modification of the articles of association, including anti-dilution clauses to protect Grifols’ stake. To this end, reinforced quorum will be included in SR’s articles of association.

· Creat has agreed not to sell its stake in SR to a competitor of Grifols and Grifols will not be able to sell its stake in Grifols Diagnostic Solutions Inc. to any Chinese company.

Moreover, Grifols and SR have entered into an exclusive strategic alliance agreement, which sets up the international manufacturing and quality standards SR needs to meet. Grifols will appoint a quality person to provide advice on and follow compliance with such agreed quality standards.

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Notes to the Consolidated Financial statements

SR will be the exclusive distributor of Grifols bioscience and diagnostic products in China.

In exchange of royalties, Grifols, S.A will provide technological and know-how support in Bioscience and Diagnostic fields to SR for use in China. Grifols will also provide engineering services to SR in exchange of fees. SR commits to use Grifols Diagnostic NAT technology in its plasma collection businesses.

This transaction is subject to the approval of the regulatory authorities of the People’s Republic of China and the United States of America. The transaction is expected to be closed in the second half of 2019.

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APPENDIX I

GRIFOLS, S.A. AND SUBSIDIARIES

Information on Group Companies, Associates and others for the years ended 31 December 2018, 2017 and 2016

|  |  |  | Acquisition / |  |  |  |  |  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
|  | Registered |  | Incorporation |  |  |  |  |  | % shares |  | % shares |  | % shares |
Name |  | Offices |  | date |  | Activity |  | Statutory Activity |  | Direct |  | Indirect |  | Direct |  | Indirect |  | Direct |  | Indirect |
Fully Consolidated Companies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Diagnostic Grifols, S.A. |  | Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain |  | 1987 |  | Industrial |  | Development and manufacture of diagnostic equipment, instruments and reagents. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Instituto Grifols, S.A. |  | Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain |  | 1987 |  | Industrial |  | Plasma fractioning and the manufacture of haemoderivative pharmaceutical products. |  | 99.998 | % | 0.002 | % | 99.998 | % | 0.002 | % | 99.998 | % | 0.002 | %
Grifols Worldwide Operations Spain, S.A (formerly Logister, S.A.) Merged with Grifols International in 2018 |  | Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain |  | 1987 |  | Services |  | Manufacture, sale and purchase, commercialisation and distribution of all types of computer products and materials. |  | — |  | — |  | — |  | 100.000 | % | — |  | 100.000 | %
Laboratorios Grifols, S.A. |  | Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain |  | 1989 |  | Industrial |  | Production of glass- and plastic-packaged parenteral solutions, parenteral and enteral nutrition products and blood extraction equipment and bags. |  | 99.999 | % | 0.001 | % | 99.999 | % | 0.001 | % | 99.999 | % | 0.001 | %
Biomat, S.A. |  | Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain |  | 1991 |  | Industrial |  | Analysis and certification of the quality of plasma used by Instituto Grifols, S.A. It also provides transfusion centres with plasma virus inactivation services (I.P.T.H). |  | 99.900 | % | 0.100 | % | 99.900 | % | 0.100 | % | 99.900 | % | 0.100 | %
Grifols Engineering, S.A. |  | Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain |  | 2000 |  | Industrial |  | Design and development of the Group’s manufacturing installations and part of the equipment and machinery used at these premises. The company also renders engineering services to external companies. |  | 99.950 | % | 0.050 | % | 99.950 | % | 0.050 | % | 99.950 | % | 0.050 | %
Biomat USA, Inc. |  | 2410 Lillyvale Avenue Los Angeles (California) United States |  | 2002 |  | Industrial |  | Procuring human plasma. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Grifols Biologicals LLC. |  | 5555 Valley Boulevard Los Angeles (California) United States |  | 2003 |  | Industrial |  | Plasma fractioning and the production of haemoderivatives. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Grifols Australia Pty Ltd. |  | Unit 5/80 Fairbank Clayton South Victoria 3149 Australia |  | 2009 |  | Industrial |  | Distribution of pharmaceutical products and the development and manufacture of reagents for diagnostics. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Medion Grifols Diagnostic AG |  | Bonnstrasse,9 3186 Dügingen Switzerland |  | 2009 |  | Industrial |  | Development and manufacturing activities in the area of biotechnology and diagnostics. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Grifols Therapeutics LLC. |  | 4101 Research Commons (Principal Address), 79 T.W. Alexander Drive, Research Triangle Park, North Carolina 277709, United States |  | 2011 |  | Industrial |  | Plasma fractioning and the production of haemoderivatives. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Talecris Plasma Resources, Inc. |  | 4101 Research Commons (Principal Address), 79 T.W. Alexander Drive, Research Triangle Park, North Carolina 277709, United States |  | 2011 |  | Industrial |  | Procuring human plasma. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Grifols Worldwide Operations Limited |  | Grange Castle Business Park, Grange Castle , Clondalkin, Dublin 22, Ireland |  | 2012 |  | Industrial |  | Packaging, labelling, storage, distribution, manufacture and development of pharmaceutical products and rendering of financial services to Group companies. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Progenika Biopharma, S.A. |  | Parque Tecnológico de Vizcaya, Edificio 504 48160 Derio (Vizcaya) Spain |  | 2013 |  | Industrial |  | Development, production and commercialisation of biotechnological solutions. |  | 99.998 | % | — |  | — |  | 90.230 | % | — |  | 89.250 | %

This appendix forms an integral part of note 2 to the consolidated annual accounts.

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|  |  |  | Acquisition / |  |  |  |  |  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
|  | Registered |  | Incorporation |  |  |  |  |  | % shares |  | % shares |  | % shares |
Name |  | Offices |  | date |  | Activity |  | Statutory Activity |  | Direct |  | Indirect |  | Direct |  | Indirect |  | Direct |  | Indirect |
Fully Consolidated Companies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Progenika Latina, S.A. de CV |  | Periferico Sur Nº 4118 Int 8 Col. Jardines del Pedregal CP 01900 Alvaro Obregon DF Mexico |  | 2013 |  | Industrial |  | Development, production and commercialisation of biotechnological solutions. |  | — |  | — |  | — |  | — |  | — |  | 89.250 | %
Progenika Inc. (Merged with Grifols Diagnostic Solutions Inc. in 2017) |  | Corporation Service Company, 2711 Centerville Road, Suite 400, Wilmington, DE 19808 United States |  | 2013 |  | Industrial |  | Development, production and commercialisation of genetic tools, diagnostic equipment and therapeutic systems and products for personalised medicine and the highest quality healthcare in general. |  | — |  | — |  | — |  | — |  | — |  | 89.250 | %
Abyntek Biopharma, S.L. |  | Parque Tecnológico de Vizcaya, Edificio 504 48160 Derio (Vizcaya) Spain |  | 2013 |  | Industrial |  | Research, development and transfer of biotechnological products and processes, as well as the commercialiation of products and services related to the biosciences. |  | — |  | — |  | — |  | — |  | — |  | 80.370 | %
Asociación I+D Progenika |  | Parque Tecnológico de Vizcaya, Edificio 504 48160 Derio (Vizcaya) Spain |  | 2013 |  | Industrial |  | Coordination, representation, management and promotion of the common interests of associated companies, in addition to contributing to the development, growth and internationalisation of its associates and of the biosciences sector in the Basque Country. |  | — |  | 99.998 | % | — |  | 90.230 | % | — |  | 89.250 | %
Grifols Diagnostics Solutions Inc (formerly G-C Diagnostics Corp.) |  | 4560 Horton Street 94608 Emeryville, California United States |  | 2013 |  | Industrial |  | Manufacture and sale of blood testing products |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols Worldwide Operations USA Inc. |  | 13111 Temple Avenue, City of Industry, California 91746-1510 Estados Unidos |  | 2014 |  | Industrial |  | The manufacture, warehousing, and logistical support for biological products. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Grifols Asia Pacific Pte, Ltd |  | 501 Orchard Road nº20-01 238880 Wheelock Place, Singapore |  | 2003 |  | Commercial |  | Distribution and sale of medical and pharmaceutical products. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols Movaco, S.A. |  | Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain |  | 1987 |  | Commercial |  | Distribution and sale of reagents, chemical products and other pharmaceutical specialities, and of medical and surgical materials, equipment and instruments for use by laboratories and health centres. |  | 99.999 | % | 0.001 | % | 99.999 | % | 0.001 | % | 99.999 | % | 0.001 | %
Grifols Portugal Productos Farmacéuticos e Hospitalares, Lda. |  | Rua de Sao Sebastiao,2 Zona Industrial Cabra Figa 2635-448 Rio de Mouro Portugal |  | 1988 |  | Commercial |  | Import, export and commercialisation of pharmaceutical and hospital equipment and products, particularly Grifols products. |  | 0.010 | % | 99.990 | % | 0.010 | % | 99.990 | % | 0.010 | % | 99.990 | %
Grifols Chile, S.A. |  | Avda. Americo Vespucio, 2242 Comuna de Conchali Santiago de Chile Chile |  | 1990 |  | Commercial |  | Development of pharmaceutical businesses, which can involve the import, production, commercialisation and export of related products. |  | 99.000 | % | — |  | 99.000 | % | — |  | 99.000 | % | — |
Grifols USA, LLC. |  | 2410 Lillyvale Avenue Los Angeles (California) Estados Unidos |  | 1990 |  | Commercial |  | Distribution and marketing of company products. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Grifols Argentina, S.A. |  | Bartolomé Mitre 3690/3790, CPB1605BUT Munro Partido de Vicente Lopez Argentina |  | 1991 |  | Commercial |  | Clinical and biological research. Preparation of reagents and therapeutic and diet products. Manufacture and commercialisation of other pharmaceutical specialities. |  | 95.010 | % | 4.990 | % | 95.010 | % | 4.990 | % | 95.010 | % | 4.990 | %
Grifols s.r.o. |  | Calle Zitna,2 Prague Czech Republic |  | 1992 |  | Commercial |  | Purchase, sale and distribution of chemical-pharmaceutical products, including human plasma. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols (Thailand) Ltd |  | 191 Silom Complex Building, 21st Follor, Silom Road, Silom, Bangrak 10500 Bangkok Thailand |  | 2003 |  | Commercial |  | Import, export and distribution of pharmaceutical products. |  | — |  | 48.000 | % | — |  | 48.000 | % | — |  | 48.000 | %
Grifols Malaysia Sdn Bhd |  | Level 18, The Gardens North Tower, Mid Valley City, Lingkaran Syed Putra 59200 Kuala Lumpur Malaysia |  | 2003 |  | Commercial |  | Distribution and sale of pharmaceutical products. |  | — |  | 30.000 | % | — |  | 30.000 | % | — |  | 30.000 | %
Grifols International, S.A. |  | Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain |  | 1997 |  | Commercial |  | Coordination of the marketing, sales and logistics for all the Group’s subsidiaries operating in other countries. |  | 99.998 | % | 0.002 | % | 99.998 | % | 0.002 | % | 99.998 | % | 0.002 | %

This appendix forms an integral part of note 2 to the consolidated annual accounts.

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|  |  |  | Acquisition / |  |  |  |  |  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
|  | Registered |  | Incorporation |  |  |  |  |  | % shares |  | % shares |  | % shares |
Name |  | Offices |  | date |  | Activity |  | Statutory Activity |  | Direct |  | Indirect |  | Direct |  | Indirect |  | Direct |  | Indirect |
Fully Consolidated Companies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Grifols Italia S.p.A |  | Via Carducci, 62d 56010 Ghezzano Pisa, Italy |  | 1997 |  | Commercial |  | Purchase, sale and distribution of chemical-pharmaceutical products. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols UK Ltd. |  | Gregory Rowcliffe & Milners, 1 Bedford Row, London WC1R 4BZ United Kingdom |  | 1997 |  | Commercial |  | Distribution and sale of therapeutic and other pharmaceutical products, especially haemoderivatives. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols Brasil, Lda. |  | Rua Umuarama, 263 Condominio Portal da Serra Vila Perneta CEP 83.325-000 Pinhais Paraná, Brazil |  | 1998 |  | Commercial |  | Import and export, preparation, distribution and sale of pharmaceutical and chemical products for laboratory and hospital use, and medical-surgical equipment and instruments. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols France, S.A.R.L. |  | Arteparc, Rue de la Belle du Canet, Bât. D, Route de la Côte d’Azur, 13590 Meyreuil France |  | 1999 |  | Commercial |  | Commercialisation of chemical and healthcare products. |  | 99.990 | % | 0.010 | % | 99.990 | % | 0.010 | % | 99.990 | % | 0.010 | %
Grifols Polska Sp.z.o.o. |  | Grzybowska 87 street00-844 Warsaw, Poland |  | 2003 |  | Commercial |  | Distribution and sale of pharmaceutical, cosmetic and other products. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Logística Grifols, S.A. de C.V. |  | Calle Eugenio Cuzin, nº 909-913 Parque Industrial Belenes Norte 45150 Zapopán Jalisco, Mexico |  | 2008 |  | Commercial |  | Manufacture and commercialisation of pharmaceutical products for human and veterinary use. |  | 99.990 | % | 0.010 | % | 99.990 | % | 0.010 | % | 99.990 | % | 0.010 | %
Grifols México, S.A. de C.V. |  | Calle Eugenio Cuzin, nº 909-913 Parque Industrial Belenes Norte 45150 Zapopán Jalisco, Mexico |  | 1993 |  | Commercial |  | Production, manufacture, adaptation, conditioning, sale and purchase, commissioning, representation and consignment of all kinds of pharmaceutical products and the acquisition of machinery, equipment, raw materials, tools, movable goods and property for the aforementioned purposes. |  | 99.980 | % | 0.020 | % | 99.980 | % | 0.020 | % | 99.980 | % | 0.020 | %
Medion Diagnostics GmbH |  | Lochamer Schlag, 12D 82166 Gräfelfing Germany |  | 2009 |  | Commercial |  | Distribution and sale of biotechnological and diagnostic products. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Grifols Nordic, AB |  | Sveavägen 166 11346 Stockholm Sweden |  | 2010 |  | Commercial |  | Research and development, production and marketing of pharmaceutical products, medical devices and any other asset deriving from the aforementioned activities. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols Colombia, Ltda |  | Carrera 7 No. 71 52 Torre B piso 9 Bogotá. D.C. Colombia |  | 2010 |  | Commercial |  | Sale, commercialisation and distribution of medicines, pharmaceutical (including but not limited to haemoderivatives) and hospital products, medical devices, biomedical equipment, laboratory instruments and reagents for diagnosis and/or healthcare software. |  | 99.990 | % | 0.010 | % | 99.990 | % | 0.010 | % | 99.990 | % | 0.010 | %
Grifols Deutschland GmbH |  | Lyoner Strasse 15, D- 60528 Frankfurt am Main Germany |  | 2011 |  | Commercial |  | Procurement of the official permits and necessary approval for the production, commercialisation and distribution of products deriving from blood plasma, as well as the import, export, distribution and sale of reagents and chemical and pharmaceutical products, especially for laboratories and health centres and surgical and medical equipment and instruments. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols Canada, Ltd. |  | 5060 Spectrum Way, Suite 405 (Principal Address) Mississauga, Ontario L4W 5N5 Canada |  | 2011 |  | Commercial |  | Distribution and sale of biotechnological products. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Grifols Pharmaceutical Technology (Shanghai) Co., Ltd. (formerly Grifols Pharmaceutical Consulting (Shanghai) Co., Ltd.) |  | Unit 901-902, Tower 2, No. 1539, West Nanjing Rd., Jing’an District, Shanghai 200040 China |  | 2013 |  | Commercial |  | Pharmaceutical consultancy services (except for diagnosis), technical and logistical consultancy services, business management and marketing consultancy services. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols Switzerland AG |  | Steinengraben, 5 40003 Basel Switzerland |  | 2013 |  | Commercial |  | Research, development, import and export and commercialisation of pharmaceutical products, devices and diagnostic instruments. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols (H.K.), Limited |  | Units 1505-7 Bershire House, 25 Westlands Road Hong Kong |  | 2014 |  | Commercial |  | Distribution and sale of diagnostic products. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %

This appendix forms an integral part of note 2 to the consolidated annual accounts.

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|  |  |  | Acquisition / |  |  |  |  |  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
|  | Registered |  | Incorporation |  |  |  |  |  | % shares |  | % shares |  | % shares |
Name |  | Offices |  | date |  | Activity |  | Statutory Activity |  | Direct |  | Indirect |  | Direct |  | Indirect |  | Direct |  | Indirect |
Fully Consolidated Companies |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Grifols Japan K.K. |  | Hilton Plaza West Office Tower, 19th floor. 2-2, Umeda 2-chome, Kita-ku Osaka-shi Japan |  | 2014 |  | Commercial |  | Research, development, import and export and commercialisation of pharmaceutical products, devices and diagnostic instruments. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols India Healthcare Private Ltd |  | Regus Business Centre Pvt.Ltd.,Level15,Dev Corpora, Plot No.463,Nr. Khajana East.Exp.Highway,Thane (W), Mumbai - 400604, Maharashtra India |  | 2014 |  | Commercial |  | Distribution and sale of pharmaceutical products. |  | 99.990 | % | 0.010 | % | 99.990 | % | 0.010 | % | 99.990 | % | 0.010 | %
Grifols Diagnostics Equipment Taiwan Limited |  | 8F., No.367, Fuxing N. RD., Songshang Dist., Taipei City 10543, Taiwan |  | 2016 |  | Commercial |  | Distribution and sale of diagnostic products. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Grifols Viajes, S.A. |  | Can Guasch, 2 08150 Parets del Vallès Barcelona, Spain |  | 1995 |  | Services |  | Travel agency exclusively serving Group companies. |  | 99.900 | % | 0.100 | % | 99.900 | % | 0.100 | % | 99.900 | % | 0.100 | %
Squadron Reinsurance Designated Activity Company (formerly Squadron Reinsurance Ltd.) |  | The Metropolitan Building, 3rd Fl. James Joyce Street, Dublin Ireland |  | 2003 |  | Services |  | Reinsurance of Group companies’ insurance policies. |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Grifols Shared Services North America, Inc. (formerly Grifols Inc.) |  | 2410 Lillivale Avenue 90032 Los Angeles, California United States |  | 2011 |  | Services |  | Support services for the collection, manufacture, sale and distribution of plasma derivatives and related products. |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Gripdan Invest, S.L |  | Avenida Diagonal 477 Barcelona, Spain |  | 2015 |  | Services |  | Manufacturing buildings for rent |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | % | — |
Gri-Cel, S.A. |  | Avenida de la Generalitat 152 Sant Cugat del Valles (Barcelona) Spain |  | 2009 |  | Research |  | Research and development in the field of regenerative medicine, awarding of research grants, subscription to collaboration agreements with entities and participation in projects in the area of regenerative medicine. |  | 0.001 | % | 99.999 | % | 0.001 | % | 99.999 | % | 0.001 | % | 99.999 | %
Araclon Biotech, S.L. |  | Paseo de Sagasta, 17 2º izqda. Zaragoza, Spain |  | 2012 |  | Research |  | Creation and commercialisation of a blood diagnosis kit for the detection of Alzheimer’s and development of effective immunotherapy (vaccine) against this disease. |  | — |  | 73.220 | % | — |  | 73.220 | % | — |  | 73.220 | %
VCN Bioscience, S.L. |  | Avenida de la Generalitat 152 Sant Cugat del Valles (Barcelona) Spain |  | 2012 |  | Research |  | Research and development of therapeutic approaches for tumours for which there is currently no effective treatment. |  | — |  | 81.340 | % | — |  | 81.340 | % | — |  | 81.340 | %
Grifols Innovation and New Technologies Limited |  | Grange Castle Business Park, Grange Castle , Clondalkin, Dublin 22, Ireland |  | 2016 |  | Research |  | Research and experimental development on biotechnology |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
PBS Acquisition Corp. |  | 2711 Centerville Road Suite 400, Wilmington, Delaware, New Castle County United States |  | 2016 |  | Services |  | Engage in any lawful act or activity for which corporations may be organized under the DGCL (Delaware Code) |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | 100.000 | %
Kiro Grifols S.L (formerly Kiro Robotics S.L) |  | Polígono Bainuetxe, 5, 2º planta, Aretxabaleta, Guipúzcoa Spain |  | 2014 |  | Research |  | Development of machines and equipment to automate and control key points of hospital processes, and hospital pharmacy processes. |  | 90.000 | % | — |  | 90.000 | % | — |  | — |  | — |
Chiquito Acquisition Corp. |  | 2711 Centerville Road Suite 400, Wilmington, Delaware, County of New Castle, United States |  | 2017 |  | Corporate |  | Engage in any lawful act or activity for which a corporation may be organized under the General Corporation Law of the State of Delaware, as amended from time to time (the “DGCL”). |  | — |  | 100.000 | % | — |  | 100.000 | % | — |  | — |
Aigües Minerals de Vilajuiga, S.A. |  | Carrer Sant Sebastià, 2, 17493 Vilajuïga, Girona |  | 2017 |  | Industrial |  | Collection and use of mineral-medicinal waters and achievement of all necessary administrative concessions in order to facilitate their industrial extraction and find the best way to take advantage of them. |  | 100.000 | % | — |  | — |  | — |  | — |  | — |
Goetech LLC (D/B/A Medkeeper) |  | 7600 Grandview Avenue, Suite 210, Arvada, CO 80002 |  | 2018 |  | Industrial |  | Development and distribution of web and mobile-based platforms for hospital pharmacies |  | — |  | 54.760 | % | — |  | — |  | — |  | — |
Haema, AG |  | LandsteinerstraBe 1, 04103 Leipzig - Germany |  | 2018 |  | Industrial |  | Procuring human plasma. |  | — |  | — |  | — |  | — |  | — |  |  |
Biotest Pharmaceutical Corporation |  | 901 Yamato Rd., Suite 101, Boca Raton FL 33431 - USA |  | 2018 |  | Industrial |  | Obtaining human plasma. |  | — |  | — |  | — |  | — |  | — |  | — |
Biotest US Corporation |  | 901 Yamato Rd., Suite 101, Boca Raton FL 33431 — USA |  | 2018 |  | Corporate |  | Corporate services to Biotest Pharmaceutical Corporation |  | — |  | — |  | — |  | — |  | — |  | — |

This appendix forms an integral part of note 2 to the consolidated annual accounts.

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|  |  |  | Acquisition / |  |  |  |  |  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
|  | Registered Offices |  | Incorporation |  |  |  |  |  | % shares |  | % shares |  | % shares |
Name |  |  | date |  | Activity |  | Statutory Activity |  | Direct |  | Indirect |  | Direct |  | Indirect |  | Direct |  | Indirect |
Equity Method consolidated companies and others |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Aradigm Corporation |  | 3929 Point Eden Way Hayward, California United States |  | 2013 |  | Research |  | Development and commercialisation of drugs delivered by inhalation for the prevention and treatment of severe respiratory diseases. |  | — |  | 35.130 | % | — |  | 35.130 | % | — |  | 35.130 | %
TiGenix N.V. |  | Romeinse straat 12 bus 2, 3001 Leuven, Belgium |  | 2013 |  | Research |  | Research and development of therapies based on stem cells taken from adipose tissue. |  | — |  | — |  | — |  | 14.180 | % | — |  | 16.130 | %
Mecwins, S.L. |  | Avenida Fernandos Casas Novoa, 37 Santiago de Compostela Spain |  | 2013 |  | Research |  | Research and production of nanotechnological, biotechnological and chemical solutions. |  | — |  | 24.990 | % | — |  | 8.420 | % | — |  | 8.420 | %
Kiro Grifols S.L (formerly Kiro Robotics S.L) |  | Polígono Bainuetxe, 5, 2º planta, Aretxabaleta, Guipúzcoa Spain |  | 2014 |  | Research |  | Development of machines and equipment to automate and control key points of hospital processes, and hospital pharmacy processes. |  | — |  | — |  | — |  | — |  | 50.000 | % | — |
Alkahest, Inc. |  | 3500 South DuPont Hwy, Dover, County of Kent United States |  | 2015 |  | Research |  | Development novel plasma-based products for the treatment of cognitive decline in aging and disorders of the central nervous system (CNS). |  | — |  | 47.580 | % | — |  | 47.580 | % | — |  | 47.580 | %
Albajuna Therapeutics, S.L |  | Hospital Germans Trias i Pujol, carretera de Canyet, s/n, Badalona Spain |  | 2016 |  | Research |  | Development and manufacture of therapeutic antibodies against HIV. |  | — |  | 30.000 | % | — |  | 30.000 | % | — |  | 30.000 | %
Interstate Blood Bank, Inc. |  | 5700 Pleasantville Road Memphis, Tennessee United States |  | 2016 |  | Industrial |  | Procuring human plasma. |  | — |  | 49.190 | % | — |  | 49.190 | % | — |  | 49.190 | %
Bio Blood Components Inc. |  | 5700 Pleasantville Road Memphis, Tennessee United States |  | 2016 |  | Industrial |  | Procuring human plasma. |  | — |  | 48.972 | % | — |  | 48.972 | % | — |  | 48.972 | %
Plasma Biological Services, LLC |  | 5700 Pleasantville Road Memphis, Tennessee United States |  | 2016 |  | Industrial |  | Procuring human plasma. |  | — |  | 48.900 | % | — |  | 48.900 | % | — |  | 48.900 | %
Singulex, Inc. |  | 4041 Forest Park Avenue St. Louis, Missouri United States |  | 2016 |  | Research |  | Development of the Single Molecule Counting (SMC™) technology for clinical diagnostic and scientific discovery. |  | — |  | 19.330 | % | — |  | 19.330 | % | — |  | 20.000 | %

This appendix forms an integral part of note 2 to the consolidated annual accounts.

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|  |  |  | Acquisition / |  |  |  |  |  | 31/12/2018 |  | 31/12/2017 |  | 31/12/2016 |
|  | Registered Offices |  | Incorporation |  |  |  |  |  | % shares |  | % shares |  | % shares |
Name |  |  | date |  | Activity |  | Statutory Activity |  | Direct |  | Indirect |  | Direct |  | Indirect |  | Direct |  | Indirect |
Equity Method consolidated companies and others |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Aigües Minerals de Vilajuiga, S.A. |  | Carrer Sant Sebastià, 2, 17493 Vilajuïga, Girona |  | 2017 |  | Industrial |  | Collection and use of mineral-medicinal waters and achievement of all necessary administrative concessions in order to facilitate their industrial extraction and find the best way to take advantage of them. |  | — |  | — |  | 50.000 | % | — |  | — |  | — |
Access Biologicals, LLC. |  | 995 Park Center Dr, Vista, CA 92081, USA |  | 2017 |  | Industrial |  | Manufacture of biological products, including specific sera and plasma-derived reagents, which are used by biotechnology and biopharmaceutical companies for in-vitro diagnostics, cell culture, and research and development in the diagnostic field. |  | — |  | 49.000 | % | — |  | 49.000 | % | — |  | — |
Access Biologicals IC-DISC, Inc. |  | 995 Park Center Dr, Vista, CA 92081, USA |  | 2017 |  | Industrial |  | Manufacture of biological products, including specific sera and plasma-derived reagents, which are used by biotechnology and biopharmaceutical companies for in-vitro diagnostics, cell culture, and research and development in the diagnostic field. |  | — |  | 49.000 | % | — |  | 49.000 | % | — |  | — |
Access Cell Culture, LLC. |  | 995 Park Center Dr, Vista, CA 92081, USA |  | 2017 |  | Industrial |  | Manufacture of biological products, including specific sera and plasma-derived reagents, which are used by biotechnology and biopharmaceutical companies for in-vitro diagnostics, cell culture, and research and development in the diagnostic field. |  | — |  | 49.000 | % | — |  | 49.000 | % | — |  | — |
Access Manufacturing, LLC. |  | 995 Park Center Dr, Vista, CA 92081, USA |  | 2017 |  | Industrial |  | Manufacture of biological products, including specific sera and plasma-derived reagents, which are used by biotechnology and biopharmaceutical companies for in-vitro diagnostics, cell culture, and research and development in the diagnostic field. |  | — |  | 49.000 | % | — |  | 49.000 | % | — |  | — |
Access Plasma, LLC. |  | 995 Park Center Dr, Vista, CA 92081, USA |  | 2017 |  | Industrial |  | Manufacture of biological products, including specific sera and plasma-derived reagents, which are used by biotechnology and biopharmaceutical companies for in-vitro diagnostics, cell culture, and research and development in the diagnostic field. |  | — |  | 49.000 | % | — |  | 49.000 | % | — |  | — |
GigaGen Inc. |  | 407 Cabot Road South San Francisco, CA 94080, USA |  | 2017 |  | Industrial |  | Engage in any lawful act or activity for which corporations may be organized under General Corporation Law. |  | — |  | 43.960 | % | — |  | 43.960 | % | — |  | — |
Plasmavita Healthcare GmbH |  | Colmarer Strasse 22, 60528 Frankfurt am Main - Germany |  | 2018 |  | Industrial |  | Procuring human plasma. |  | — |  | 50.000 | % | — |  | — |  | — |  | — |

This appendix forms an integral part of note 2 to the consolidated annual accounts.

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APPENDIX II

GRIFOLS, S.A. AND SUBSIDIARIES

Operating Segments for the years ended 31 December 2018, 2017 and 2016

(Expressed in thousands of Euros)

|  | Bioscience |  | Hospital |  | Diagnostic |  | Bio Supplies |  | Others |  | Intersegments |  | Consolidated |
|  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |
Revenues from external customers |  | 3,516,704 |  | 3,429,785 |  | 3,195,424 |  | 119,454 |  | 105,649 |  | 102,251 |  | 702,265 |  | 732,369 |  | 691,701 |  | 167,004 |  | 66,791 |  | 57,239 |  | 22,451 |  | 18,263 |  | 34,601 |  | (41,154 | ) | (34,784 | ) | (31,386 | ) | 4,486,724 |  | 4,318,073 |  | 4,049,830 |
Total operating income |  | 3,516,704 |  | 3,429,785 |  | 3,195,424 |  | 119,454 |  | 105,649 |  | 102,251 |  | 702,265 |  | 732,369 |  | 691,701 |  | 167,004 |  | 66,791 |  | 57,239 |  | 22,451 |  | 18,263 |  | 34,601 |  | (41,154 | ) | (34,784 | ) | (31,386 | ) | 4,486,724 |  | 4,318,073 |  | 4,049,830 |
Profit/(Loss) for the segment |  | 902,402 |  | 985,495 |  | 913,840 |  | (12,587 | ) | (9,766 | ) | (8,765 | ) | 215,990 |  | 248,080 |  | 97,320 |  | 36,824 |  | 35,598 |  | 33,794 |  | 19,788 |  | (9,632 | ) | 44,324 |  | (5,764 | ) | (12,305 | ) | (1,316 | ) | 1,156,653 |  | 1,237,470 |  | 1,079,197 |
Unallocated expenses |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | (162,529 | ) | (234,127 | ) | (139,789 | )
Operating profit |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 994,124 |  | 1,003,343 |  | 939,408 |
Finance result |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | (257,244 | ) | (287,734 | ) | (233,589 | )
Share of profit/(loss) of equity accounted investee |  | 2,839 |  | (10,434 | ) | (9,396 | ) | — |  | 2,112 |  | (5,611 | ) | (10,975 | ) | (9,335 | ) | — |  | 3,039 |  | 1,830 |  | — |  | (5,941 | ) | (4,060 | ) | 21,940 |  | — |  | — |  | — |  | (11,038 | ) | (19,887 | ) | 6,933 |
Income tax expense |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | (131,436 | ) | (34,408 | ) | (168,209 | )
Profit for the year after tax |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 594,406 |  | 661,314 |  | 544,543 |
Segment assets |  | 6,928,220 |  | 6,007,153 |  | 6,524,922 |  | 250,543 |  | 145,477 |  | 86,590 |  | 3,526,136 |  | 3,356,185 |  | 1,909,447 |  | 117,673 |  | 7,409 |  | 8,378 |  | 54,363 |  | 60,449 |  | 40,160 |  | (29,281 | ) | (22,196 | ) | (11,964 | ) | 10,847,654 |  | 9,554,477 |  | 8,557,533 |
Equity accounted investments |  | 99,547 |  | 83,905 |  | 104,996 |  | — |  | — |  | 13,888 |  | 19,256 |  | 29,322 |  | 43,330 |  | 47,742 |  | 44,220 |  | — |  | 60,360 |  | 61,562 |  | 39,131 |  | — |  | — |  | — |  | 226,905 |  | 219,009 |  | 201,345 |
Unallocated assets |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | 1,402,487 |  | 1,146,778 |  | 1,370,894 |
Total assets |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 12,477,046 |  | 10,920,264 |  | 10,129,772 |
Segment liabilities |  | 764,377 |  | 423,415 |  | 411,604 |  | 32,767 |  | 13,560 |  | 8,415 |  | 230,517 |  | 192,720 |  | 186,389 |  | 6,427 |  | — |  | — |  | 34,698 |  | 26,903 |  | 1,843 |  | — |  | — |  | — |  | 1,068,786 |  | 656,598 |  | 608,251 |
Unallocated liabilities |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | 6,711,656 |  | 6,629,701 |  | 5,793,543 |
Total liabilities |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | 7,780,442 |  | 7,286,299 |  | 6,401,794 |
Other information: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Amortisation and depreciation allocated |  | 156,893 |  | 157,478 |  | 152,821 |  | 10,819 |  | 6,436 |  | 5,915 |  | 44,030 |  | 40,815 |  | 32,180 |  | 5,656 |  | — |  | — |  | 1,941 |  | 2,237 |  | 3,445 |  | — |  | — |  | — |  | 219,339 |  | 206,966 |  | 194,361 |
Amortisation and depreciation unallocated |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | 9,270 |  | 8,524 |  | 7,508 |
Expenses that do not require cash payments allocated |  | 172,648 |  | 7,049 |  | 16,219 |  | 297 |  | (514 | ) | 306 |  | (27,651 | ) | (4,423 | ) | (2,001 | ) | 28 |  | — |  | — |  | — |  | — |  | (32,534 | ) | — |  | — |  | — |  | 145,322 |  | 2,112 |  | (18,010 | )
Expenses that do not require cash payments unallocated |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | 1,339 |  | (58,752 | ) | 4,608 |
Additions for the year of property, plant & equipment and intangible assets allocated |  | 220,531 |  | 227,635 |  | 197,741 |  | 15,354 |  | 10,429 |  | 9,193 |  | 58,064 |  | 70,032 |  | 89,760 |  | 2,050 |  | 198 |  | 84 |  | 883 |  | 20,911 |  | 13,313 |  | — |  | — |  | — |  | 296,882 |  | 329,205 |  | 310,091 |
Additions for the year of property, plant & equipment and intangible assets unallocated |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | — |  | 19,795 |  | 11,268 |  | 12,011 |

* As a result of the creation of Bio Supplies segment and intersegments, the Group has reviewed the allocation of balances and transactions by segments. The comparative figure for year 2016 have been restated accordingly.

This appendix forms an integral part of note 6 to the consolidated financial statements.

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APPENDIX II

GRIFOLS, S.A. AND SUBSIDIARIES

Reporting by geographical area

for the years ended 31 December 2018, 2017 and 2016

(Expressed in thousands of Euros)

|  | Spain |  | Rest of European Union |  | USA + Canada |  | Rest of World |  | Consolidated |
|  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |  | 2018 |  | 2017 |  | 2016 |
Net Revenue |  | 264,913 |  | 242,894 |  | 225,273 |  | 535,361 |  | 444,089 |  | 426,223 |  | 2,974,429 |  | 2,896,505 |  | 2,707,579 |  | 712,021 |  | 734,585 |  | 690,755 |  | 4,486,724 |  | 4,318,073 |  | 4,049,830 |
Assets by geographical area |  | 898,599 |  | 899,223 |  | 847,467 |  | 3,177,781 |  | 2,397,200 |  | 2,467,295 |  | 8,133,108 |  | 7,341,174 |  | 6,535,420 |  | 267,558 |  | 282,667 |  | 279,590 |  | 12,477,046 |  | 10,920,264 |  | 10,129,772 |
Other information: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Additions for the year of property, plant & equipment and intangible assets |  | 70,639 |  | 62,271 |  | 73,365 |  | 69,534 |  | 80,910 |  | 39,603 |  | 166,353 |  | 188,557 |  | 190,358 |  | 10,151 |  | 8,735 |  | 18,776 |  | 316,677 |  | 340,473 |  | 322,102 |

This appendix forms an integral part of note 6 to the consolidated financial statements.

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APPENDIX III

GRIFOLS, S.A. AND SUBSIDIARIES

Changes in Other Intangible Assets

for the year ended

31 December 2018

(Expressed in thousands of Euros)

|  | Balances at |  |  |  | Business |  |  |  |  |  | Translation |  | Balances at |
|  | 12/31/2017 |  | Additions |  | combinations |  | Transfers |  | Disposals |  | differences |  | 12/31/2018 |
Development costs |  | 311,694 |  | 55,439 |  | — |  | — |  | (36 | ) | 10,215 |  | 377,312 |
Concessions, patents, licenses brands & similar |  | 182,885 |  | — |  | 6,225 |  | — |  | (757 | ) | 8,057 |  | 196,410 |
Computer software |  | 174,945 |  | 20,252 |  | 34,319 |  | (762 | ) | (1,116 | ) | 6,785 |  | 234,423 |
Currently marketed products |  | 1,024,376 |  | — |  | — |  | — |  | — |  | 47,451 |  | 1,071,827 |
Other intangible assets |  | 147,307 |  | 48 |  | 19,749 |  | — |  | — |  | 7,664 |  | 174,768 |
Total cost of intangible assets |  | 1,841,207 |  | 75,739 |  | 60,293 |  | (762 | ) | (1,909 | ) | 80,172 |  | 2,054,740 |
Accum. amort. of development costs |  | (79,349 | ) | (10,660 | ) | — |  | — |  | — |  | (98 | ) | (90,107 | )
Accum. amort of concessions, patents, licenses, brands & similar |  | (29,783 | ) | (6,132 | ) | — |  | — |  | — |  | (845 | ) | (36,760 | )
Accum. amort. of computer software |  | (106,319 | ) | (12,918 | ) | (5,872 | ) | — |  | 1,116 |  | (2,660 | ) | (126,653 | )
Accum. amort. of currently marketed products |  | (231,068 | ) | (36,154 | ) | — |  | — |  | — |  | (11,573 | ) | (278,795 | )
Accum. amort. of other intangible assets |  | (61,966 | ) | (5,536 | ) | — |  | 246 |  | — |  | (3,297 | ) | (70,553 | )
Total accum. amort intangible assets |  | (508,485 | ) | (71,400 | ) | (5,872 | ) | 246 |  | 1,116 |  | (18,473 | ) | (602,868 | )
Impairment of other intangible assets |  | (63,380 | ) | — |  | — |  | — |  | — |  | (2,955 | ) | (66,335 | )
Carrying amount of intangible assets |  | 1,269,342 |  | 4,339 |  | 54,421 |  | (516 | ) | (793 | ) | 58,744 |  | 1,385,537 |

(See note 3)

This appendix forms an integral part of note 8 to the consolidated financial statements.

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APPENDIX III

GRIFOLS, S.A. AND SUBSIDIARIES

Changes in Other Intangible Assets

for the year ended

31 December 2017

(Expressed in thousands of Euros)

|  | Balances at |  |  |  | Business |  |  |  |  |  | Translation |  | Balances at |
|  | 12/31/2016 |  | Additions |  | combinations * |  | Transfers |  | Disposals |  | differences |  | 12/31/2017 |
Development costs |  | 142,693 |  | 43,152 |  | 142,529 |  | — |  | (81 | ) | (16,599 | ) | 311,694 |
Concessions, patents, licenses brands & similar |  | 60,471 |  | — |  | 142,174 |  | — |  | — |  | (19,760 | ) | 182,885 |
Computer software |  | 168,623 |  | 19,626 |  | 26 |  | 529 |  | (126 | ) | (13,733 | ) | 174,945 |
Currently marketed products |  | 1,162,204 |  | — |  | — |  | — |  | — |  | (137,828 | ) | 1,024,376 |
Other intangible assets |  | 148,682 |  | 17,348 |  | — |  | — |  | — |  | (18,723 | ) | 147,307 |
Total cost of intangible assets |  | 1,682,673 |  | 80,126 |  | 284,729 |  | 529 |  | (207 | ) | (206,643 | ) | 1,841,207 |
Accum. amort. of development costs |  | (72,073 | ) | (5,834 | ) | — |  | — |  | — |  | (1,442 | ) | (79,349 | )
Accum. amort of concessions, patents, licenses, brands & similar |  | (24,994 | ) | (6,004 | ) | — |  | — |  | — |  | 1,215 |  | (29,783 | )
Accum. amort. of computer software |  | (99,927 | ) | (13,549 | ) | — |  | — |  | 111 |  | 7,046 |  | (106,319 | )
Accum. amort. of currently marketed products |  | (220,988 | ) | (38,216 | ) | — |  | — |  | — |  | 28,136 |  | (231,068 | )
Accum. amort. of other intangible assets |  | (69,389 | ) | (865 | ) | — |  | — |  | — |  | 8,288 |  | (61,966 | )
Total accum. amort intangible assets |  | (487,371 | ) | (64,468 | ) | — |  | — |  | 111 |  | 43,243 |  | (508,485 | )
Impairment of other intangible assets |  | — |  | (64,734 | ) | — |  | — |  | — |  | 1,354 |  | (63,380 | )
Carrying amount of intangible assets |  | 1,195,302 |  | (49,076 | ) | 284,729 |  | 529 |  | (96 | ) | (162,046 | ) | 1,269,342 |

(See note 3)

This appendix forms an integral part of note 8 to the consolidated financial statements.

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APPENDIX IV

GRIFOLS, S.A. AND SUBSIDIARIES

Movement in Property, Plant and Equipment

for the year ended

31 December 2018

(Expressed in thousands of Euros)

|  | Balances at |  |  |  | Business |  |  |  |  |  | Translation |  | Balances at |
|  | 31/12/2017 |  | Additions |  | combination |  | Transfers |  | Disposals |  | differences |  | 31/12/2018 |
Cost: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Land and buildings |  | 673,534 |  | 1,223 |  | 19,344 |  | 6,051 |  | (280 | ) | 26,540 |  | 726,412 |
Plant and machinery |  | 1,704,679 |  | 57,699 |  | 79,003 |  | 100,961 |  | (15,855 | ) | 58,366 |  | 1,984,853 |
Fixed Assets under construction |  | 262,119 |  | 182,016 |  | 1,746 |  | (106,473 | ) | — |  | 5,983 |  | 345,391 |
|  | 2,640,332 |  | 240,938 |  | 100,093 |  | 539 |  | (16,135 | ) | 90,889 |  | 3,056,656 |
Accumulated depreciation: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Buildings |  | (66,765 | ) | (15,224 | ) | (4,682 | ) | — |  | 222 |  | (2,929 | ) | (89,378 | )
Plant and machinery |  | (810,782 | ) | (141,985 | ) | (46,995 | ) | (23 | ) | 13,025 |  | (25,975 | ) | (1,012,735 | )
|  | (877,547 | ) | (157,209 | ) | (51,677 | ) | (23 | ) | 13,247 |  | (28,904 | ) | (1,102,113 | )
Impairment of other property, plant and equipment |  | (2,732 | ) | 81 |  | — |  | — |  | — |  | 91 |  | (2,560 | )
Carrying amount |  | 1,760,053 |  | 83,810 |  | 48,416 |  | 516 |  | (2,888 | ) | 62,076 |  | 1,951,983 |

(See note 3)

This appendix forms an integral part of note 9 to the consolidated financial statements.

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APPENDIX IV

GRIFOLS, S.A. AND SUBSIDIARIES

Movement in Property, Plant and Equipment

for the year ended

31 December 2017

(Expressed in thousands of Euros)

|  | Balances at |  |  |  | Business |  |  |  |  |  | Translation |  | Balances at |
|  | 31/12/2016 |  | Additions |  | combination |  | Transfers |  | Disposals |  | differences |  | 31/12/2017 |
Cost: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Land and buildings |  | 687,856 |  | 28,503 |  | 19,628 |  | 12,694 |  | (823 | ) | (74,324 | ) | 673,534 |
Plant and machinery |  | 1,655,837 |  | 82,234 |  | 9,068 |  | 123,816 |  | (10,098 | ) | (156,178 | ) | 1,704,679 |
Fixed Assets under construction |  | 275,003 |  | 149,610 |  | 555 |  | (137,073 | ) | — |  | (25,976 | ) | 262,119 |
|  | 2,618,696 |  | 260,347 |  | 29,251 |  | (563 | ) | (10,921 | ) | (256,478 | ) | 2,640,332 |
Accumulated depreciation: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Buildings |  | (59,376 | ) | (14,708 | ) | — |  | — |  | 710 |  | 6,609 |  | (66,765 | )
Plant and machinery |  | (746,268 | ) | (136,314 | ) | — |  | 34 |  | 7,993 |  | 63,773 |  | (810,782 | )
|  | (805,644 | ) | (151,022 | ) | — |  | 34 |  | 8,703 |  | 70,382 |  | (877,547 | )
Impairment of other property, plant and equipment |  | (3,200 | ) | 258 |  | — |  | — |  | — |  | 210 |  | (2,732 | )
Carrying amount |  | 1,809,852 |  | 109,583 |  | 29,251 |  | (529 | ) | (2,218 | ) | (185,886 | ) | 1,760,053 |

(See note 3)

This appendix forms an integral part of note 9 to the consolidated financial statements.

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APPENDIX V

GRIFOLS, S.A. AND SUBSIDIARIES

Statement of Liquidity for Distribution of Interim Dividend 2018

(Expressed in thousands of Euros)

|  | Thousands of Euros |
Forecast profits distributable for 2018: |  |  |
Projected profits net of taxes until 31/12/2018 |  | 258,091 |
Less, charge required to legal reserve |  | — |
Estimated profits distributable for 2018 |  | 258,091 |
Interim dividend distributed |  | 136,747 |
Forecast cash for the period 26 October 2018 to 26 October 2019: |  |  |
Cash balances at 26 October 2018 |  | — |
Projected amounts collected |  | 572,263 |
Projected payments, including interim dividend |  | 544,112 |
Projected cash balances at 26 October 2019 |  | 28,151 |

This appendix forms an integral part of note 15 to the consolidated financial statements.

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APPENDIX V

GRIFOLS, S.A. AND SUBSIDIARIES

Statement of Liquidity for Distribution of Interim Dividend 2017

(Expressed in thousands of Euros)

|  | Thousands of Euros |
Forecast profits distributable for 2017: |  |  |
Projected profits net of taxes until 31/12/2017 |  | 273,472 |
Less, charge required to legal reserve |  | — |
Estimated profits distributable for 2017 |  | 273,472 |
Interim dividend distributed |  | 122,986 |
Forecast cash for the period 15 December 2017 to 15 December 2018: |  |  |
Cash balances at 15 December 2017 |  | — |
Projected amounts collected |  | 475,209 |
Projected payments, including interim dividend |  | 468,117 |
Projected cash balances at 15 December 2018 |  | 7,092 |

This appendix forms an integral part of note 15 to the consolidated financial statements.

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SIGNATURES

The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.

| GRIFOLS, S.A.
| By: | /s/ Víctor Grifols Deu
|  | Name: Víctor Grifols Deu
|  | Title: Director and Co-Chief Executive Officer
| GRIFOLS, S.A.
| By: | /s/ Raimon Grifols Roura
|  | Name: Raimon Grifols Roura
|  | Title: Director and Co-Chief Executive Officer
Date: April 5, 2019 |  |