false2022FY0001145197http://fasb.org/us-gaap/2022#AccountingStandardsUpdate201613Memberhttp://fasb.org/us-gaap/2022#AccountingStandardsUpdate202006Memberhttp://fasb.org/us-gaap/2022#OtherAssetsNoncurrenthttp://fasb.org/us-gaap/2022#OtherAssetsNoncurrenthttp://fasb.org/us-gaap/2022#AccruedLiabilitiesCurrenthttp://fasb.org/us-gaap/2022#AccruedLiabilitiesCurrenthttp://fasb.org/us-gaap/2022#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2022#OtherLiabilitiesNoncurrent0.004410500011451972022-01-012022-12-3100011451972022-06-30iso4217:USD00011451972023-02-16xbrli:shares00011451972022-12-3100011451972021-12-31iso4217:USDxbrli:shares00011451972021-01-012021-12-3100011451972020-01-012020-12-310001145197us-gaap:CommonStockMember2019-12-310001145197us-gaap:AdditionalPaidInCapitalMember2019-12-310001145197us-gaap:RetainedEarningsMember2019-12-310001145197us-gaap:AccumulatedOtherComprehensiveIncomeMember2019-12-3100011451972019-12-3100011451972019-01-012019-12-310001145197us-gaap:RetainedEarningsMembersrt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2019-12-310001145197srt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2019-12-310001145197us-gaap:CommonStockMember2020-01-012020-12-310001145197us-gaap:AdditionalPaidInCapitalMember2020-01-012020-12-310001145197us-gaap:RetainedEarningsMember2020-01-012020-12-310001145197us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-01-012020-12-310001145197us-gaap:CommonStockMember2020-12-310001145197us-gaap:AdditionalPaidInCapitalMember2020-12-310001145197us-gaap:RetainedEarningsMember2020-12-310001145197us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-12-3100011451972020-12-310001145197us-gaap:CommonStockMember2021-01-012021-12-310001145197us-gaap:AdditionalPaidInCapitalMember2021-01-012021-12-310001145197podd:ConvertibleSeniorNotes1.375Member2021-12-31xbrli:pure0001145197us-gaap:RetainedEarningsMember2021-01-012021-12-310001145197us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-01-012021-12-310001145197us-gaap:CommonStockMember2021-12-310001145197us-gaap:AdditionalPaidInCapitalMember2021-12-310001145197us-gaap:RetainedEarningsMember2021-12-310001145197us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-12-310001145197us-gaap:AdditionalPaidInCapitalMembersrt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2021-12-310001145197us-gaap:RetainedEarningsMembersrt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2021-12-310001145197srt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2021-12-310001145197us-gaap:CommonStockMember2022-01-012022-12-310001145197us-gaap:AdditionalPaidInCapitalMember2022-01-012022-12-310001145197us-gaap:RetainedEarningsMember2022-01-012022-12-310001145197us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-01-012022-12-310001145197us-gaap:CommonStockMember2022-12-310001145197us-gaap:AdditionalPaidInCapitalMember2022-12-310001145197us-gaap:RetainedEarningsMember2022-12-310001145197us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-12-310001145197podd:StrategicInvestmentOneMember2022-01-012022-12-310001145197podd:StrategicInvestmentTwoMember2022-01-012022-12-310001145197us-gaap:RetainedEarningsMembersrt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2020-01-010001145197us-gaap:BuildingAndBuildingImprovementsMembersrt:MinimumMember2022-01-012022-12-310001145197us-gaap:BuildingAndBuildingImprovementsMembersrt:MaximumMember2022-01-012022-12-310001145197srt:MinimumMemberus-gaap:MachineryAndEquipmentMember2022-01-012022-12-310001145197srt:MaximumMemberus-gaap:MachineryAndEquipmentMember2022-01-012022-12-310001145197srt:MinimumMemberus-gaap:FurnitureAndFixturesMember2022-01-012022-12-310001145197srt:MaximumMemberus-gaap:FurnitureAndFixturesMember2022-01-012022-12-310001145197us-gaap:CustomerRelationshipsMember2022-01-012022-12-310001145197srt:MinimumMemberus-gaap:SoftwareAndSoftwareDevelopmentCostsMember2022-01-012022-12-310001145197srt:MaximumMemberus-gaap:SoftwareAndSoftwareDevelopmentCostsMember2022-01-012022-12-310001145197us-gaap:DevelopedTechnologyRightsMembersrt:MinimumMember2022-01-012022-12-310001145197srt:MaximumMemberus-gaap:DevelopedTechnologyRightsMember2022-01-012022-12-310001145197us-gaap:PatentsMembersrt:MinimumMember2022-01-012022-12-310001145197us-gaap:PatentsMembersrt:MaximumMember2022-01-012022-12-310001145197podd:UnitedStatesAndEuropeMember2022-01-012022-12-310001145197country:CA2022-01-012022-12-310001145197us-gaap:ShippingAndHandlingMember2022-01-012022-12-310001145197us-gaap:ShippingAndHandlingMember2021-01-012021-12-310001145197us-gaap:ShippingAndHandlingMember2020-01-012020-12-310001145197srt:CumulativeEffectPeriodOfAdoptionAdjustmentMemberus-gaap:AccountingStandardsUpdate202006Member2022-01-010001145197srt:CumulativeEffectPeriodOfAdoptionAdjustedBalanceMemberus-gaap:AccountingStandardsUpdate202006Member2022-01-01podd:segment0001145197country:US2022-01-012022-12-310001145197country:US2021-01-012021-12-310001145197country:US2020-01-012020-12-310001145197us-gaap:NonUsMember2022-01-012022-12-310001145197us-gaap:NonUsMember2021-01-012021-12-310001145197us-gaap:NonUsMember2020-01-012020-12-310001145197country:US2022-12-310001145197country:US2021-12-310001145197country:CN2022-12-310001145197country:CN2021-12-310001145197country:MY2022-12-310001145197country:MY2021-12-310001145197podd:OtherGeographicalLocationMember2022-12-310001145197podd:OtherGeographicalLocationMember2021-12-310001145197podd:U.S.OmnipodMember2022-01-012022-12-310001145197podd:U.S.OmnipodMember2021-01-012021-12-310001145197podd:U.S.OmnipodMember2020-01-012020-12-310001145197podd:InternationalOmnipodMember2022-01-012022-12-310001145197podd:InternationalOmnipodMember2021-01-012021-12-310001145197podd:InternationalOmnipodMember2020-01-012020-12-310001145197podd:ProductOmnipodMember2022-01-012022-12-310001145197podd:ProductOmnipodMember2021-01-012021-12-310001145197podd:ProductOmnipodMember2020-01-012020-12-310001145197podd:DrugDeliveryMember2022-01-012022-12-310001145197podd:DrugDeliveryMember2021-01-012021-12-310001145197podd:DrugDeliveryMember2020-01-012020-12-310001145197podd:DistributorAMemberus-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMember2022-01-012022-12-310001145197us-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMemberpodd:DistributorBMember2022-01-012022-12-310001145197us-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMemberpodd:DistributorBMember2021-01-012021-12-310001145197us-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMemberpodd:DistributorBMember2020-01-012020-12-310001145197podd:DistributorCMemberus-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMember2021-01-012021-12-310001145197podd:DistributorCMemberus-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMember2020-01-012020-12-310001145197podd:DistributorDMemberus-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMember2022-01-012022-12-310001145197us-gaap:CashMember2022-12-310001145197us-gaap:CashMember2021-12-310001145197us-gaap:MoneyMarketFundsMember2022-12-310001145197us-gaap:MoneyMarketFundsMember2021-12-310001145197us-gaap:BankTimeDepositsMember2022-12-310001145197us-gaap:BankTimeDepositsMember2021-12-310001145197us-gaap:TradeAccountsReceivableMember2022-12-310001145197us-gaap:TradeAccountsReceivableMember2021-12-310001145197us-gaap:UnbilledRevenuesMember2022-12-310001145197us-gaap:UnbilledRevenuesMember2021-12-310001145197us-gaap:AccountsReceivableMemberpodd:DistributorAMemberus-gaap:CustomerConcentrationRiskMember2022-01-012022-12-310001145197us-gaap:AccountsReceivableMemberpodd:DistributorAMemberus-gaap:CustomerConcentrationRiskMember2021-01-012021-12-310001145197us-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMemberpodd:DistributorBMember2022-01-012022-12-310001145197us-gaap:AccountsReceivableMemberpodd:DistributorDMemberus-gaap:CustomerConcentrationRiskMember2022-01-012022-12-310001145197us-gaap:AccountsReceivableMemberpodd:DistributorDMemberus-gaap:CustomerConcentrationRiskMember2021-01-012021-12-310001145197srt:MinimumMemberpodd:CloudComputingCostsMember2022-01-012022-12-310001145197srt:MaximumMemberpodd:CloudComputingCostsMember2022-01-012022-12-310001145197us-gaap:LandMember2022-12-310001145197us-gaap:LandMember2021-12-310001145197us-gaap:BuildingMember2022-12-310001145197us-gaap:BuildingMember2021-12-310001145197us-gaap:MachineryAndEquipmentMember2022-12-310001145197us-gaap:MachineryAndEquipmentMember2021-12-310001145197us-gaap:FurnitureAndFixturesMember2022-12-310001145197us-gaap:FurnitureAndFixturesMember2021-12-310001145197us-gaap:LeaseholdImprovementsMember2022-12-310001145197us-gaap:LeaseholdImprovementsMember2021-12-310001145197us-gaap:ConstructionInProgressMember2022-12-310001145197us-gaap:ConstructionInProgressMember2021-12-310001145197podd:DynalloyIncMember2022-01-032022-01-030001145197podd:DynalloyIncMemberus-gaap:SubsequentEventMember2023-01-012023-01-310001145197podd:DynalloyIncMember2022-01-030001145197us-gaap:CustomerRelationshipsMember2022-12-310001145197us-gaap:CustomerRelationshipsMember2021-12-310001145197us-gaap:SoftwareAndSoftwareDevelopmentCostsMember2022-12-310001145197us-gaap:SoftwareAndSoftwareDevelopmentCostsMember2021-12-310001145197us-gaap:DevelopedTechnologyRightsMember2022-12-310001145197us-gaap:DevelopedTechnologyRightsMember2021-12-310001145197us-gaap:PatentsMember2022-12-310001145197us-gaap:PatentsMember2021-12-310001145197podd:FeesToFormerEuropeanDistributorMember2020-10-012020-12-3100011451972022-10-012022-10-3100011451972022-12-012022-12-310001145197us-gaap:RevolvingCreditFacilityMember2022-12-310001145197us-gaap:RevolvingCreditFacilityMember2021-12-310001145197podd:EquipmentFinancingDueMay2024Memberus-gaap:SecuredDebtMember2022-12-310001145197podd:EquipmentFinancingDueMay2024Memberus-gaap:SecuredDebtMember2021-12-310001145197podd:EquipmentFinancingDueNovember2025Memberus-gaap:SecuredDebtMember2022-12-310001145197podd:EquipmentFinancingDueNovember2025Memberus-gaap:SecuredDebtMember2021-12-310001145197podd:A515MortgageDueNov2025Memberus-gaap:SecuredDebtMember2022-12-310001145197podd:A515MortgageDueNov2025Memberus-gaap:SecuredDebtMember2021-12-310001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes0375Member2022-12-310001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes0375Member2021-12-310001145197us-gaap:SecuredDebtMemberpodd:TermLoanDueMay2028Member2022-12-310001145197us-gaap:SecuredDebtMemberpodd:TermLoanDueMay2028Member2021-12-310001145197us-gaap:SecuredDebtMemberpodd:EquipmentFinancingDueJuly2028Member2022-12-310001145197us-gaap:SecuredDebtMemberpodd:EquipmentFinancingDueJuly2028Member2021-12-310001145197us-gaap:SecuredDebtMemberpodd:EquipmentFinancingTransactionMember2020-10-31podd:manufacturing_line0001145197podd:EquipmentFinancingTransactionOneMemberus-gaap:SecuredDebtMember2020-10-012020-10-310001145197podd:EquipmentFinancingTransactionOneMemberus-gaap:SecuredDebtMember2020-10-310001145197podd:EquipmentFinancingTransactionTwoMemberus-gaap:SecuredDebtMember2020-10-012020-10-310001145197podd:EquipmentFinancingTransactionTwoMemberus-gaap:SecuredDebtMember2020-10-310001145197us-gaap:SecuredDebtMemberpodd:EquipmentFinancingTransactionMember2021-07-310001145197us-gaap:SecuredDebtMemberpodd:EquipmentFinancingTransactionMember2021-07-012021-07-310001145197podd:A515MortgageDueNov2025Memberus-gaap:SecuredDebtMember2020-10-310001145197podd:A515MortgageDueNov2025Memberus-gaap:SecuredDebtMember2020-10-012020-10-310001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes0375Member2019-09-300001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes0375Member2019-09-012019-09-300001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes1.25Member2019-09-300001145197us-gaap:ConvertibleDebtMemberus-gaap:PriceRiskDerivativeMemberpodd:ConvertibleSeniorNotes0375Member2019-09-30iso4217:USDpodd:option0001145197us-gaap:SecuredDebtMemberpodd:SeniorSecuredTermLoanBMember2021-05-310001145197us-gaap:SecuredDebtMemberpodd:SeniorSecuredTermLoanBMember2021-05-012021-05-310001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes1.375Member2021-12-310001145197us-gaap:SecuredOvernightFinancingRateSofrOvernightIndexSwapRateMemberus-gaap:SecuredDebtMemberpodd:SeniorSecuredTermLoanBMember2022-11-302022-11-300001145197us-gaap:SecuredDebtMemberus-gaap:RevolvingCreditFacilityMember2021-05-012021-05-310001145197us-gaap:SecuredOvernightFinancingRateSofrOvernightIndexSwapRateMembersrt:MinimumMemberus-gaap:SecuredDebtMemberus-gaap:RevolvingCreditFacilityMember2021-05-012021-05-310001145197us-gaap:SecuredDebtMemberus-gaap:RevolvingCreditFacilityMember2022-12-310001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes1.375Member2021-01-012021-12-310001145197us-gaap:SecuredDebtMemberus-gaap:CarryingReportedAmountFairValueDisclosureMemberpodd:TermLoanDueMay2028Memberus-gaap:FairValueInputsLevel2Member2022-12-310001145197us-gaap:EstimateOfFairValueFairValueDisclosureMemberus-gaap:SecuredDebtMemberpodd:TermLoanDueMay2028Memberus-gaap:FairValueInputsLevel2Member2022-12-310001145197us-gaap:SecuredDebtMemberus-gaap:CarryingReportedAmountFairValueDisclosureMemberpodd:TermLoanDueMay2028Memberus-gaap:FairValueInputsLevel2Member2021-12-310001145197us-gaap:EstimateOfFairValueFairValueDisclosureMemberus-gaap:SecuredDebtMemberpodd:TermLoanDueMay2028Memberus-gaap:FairValueInputsLevel2Member2021-12-310001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes0375Memberus-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2022-12-310001145197us-gaap:ConvertibleDebtMemberus-gaap:EstimateOfFairValueFairValueDisclosureMemberpodd:ConvertibleSeniorNotes0375Memberus-gaap:FairValueInputsLevel2Member2022-12-310001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes0375Memberus-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2021-12-310001145197us-gaap:ConvertibleDebtMemberus-gaap:EstimateOfFairValueFairValueDisclosureMemberpodd:ConvertibleSeniorNotes0375Memberus-gaap:FairValueInputsLevel2Member2021-12-310001145197podd:EquipmentFinancingsMemberus-gaap:SecuredDebtMemberus-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2022-12-310001145197us-gaap:EstimateOfFairValueFairValueDisclosureMemberpodd:EquipmentFinancingsMemberus-gaap:SecuredDebtMemberus-gaap:FairValueInputsLevel2Member2022-12-310001145197podd:EquipmentFinancingsMemberus-gaap:SecuredDebtMemberus-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2021-12-310001145197us-gaap:EstimateOfFairValueFairValueDisclosureMemberpodd:EquipmentFinancingsMemberus-gaap:SecuredDebtMemberus-gaap:FairValueInputsLevel2Member2021-12-310001145197podd:A515MortgageDueNov2025Memberus-gaap:SecuredDebtMemberus-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2022-12-310001145197us-gaap:EstimateOfFairValueFairValueDisclosureMemberpodd:A515MortgageDueNov2025Memberus-gaap:SecuredDebtMemberus-gaap:FairValueInputsLevel2Member2022-12-310001145197podd:A515MortgageDueNov2025Memberus-gaap:SecuredDebtMemberus-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2021-12-310001145197us-gaap:EstimateOfFairValueFairValueDisclosureMemberpodd:A515MortgageDueNov2025Memberus-gaap:SecuredDebtMemberus-gaap:FairValueInputsLevel2Member2021-12-310001145197us-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2022-12-310001145197us-gaap:EstimateOfFairValueFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2022-12-310001145197us-gaap:CarryingReportedAmountFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2021-12-310001145197us-gaap:EstimateOfFairValueFairValueDisclosureMemberus-gaap:FairValueInputsLevel2Member2021-12-310001145197us-gaap:ConvertibleDebtMemberpodd:ConvertibleSeniorNotes0375Member2022-01-012022-12-310001145197us-gaap:InterestRateSwapMember2022-12-310001145197us-gaap:InterestRateSwapMember2021-12-310001145197us-gaap:InterestRateSwapMember2022-01-012022-12-310001145197podd:PatentInfringementLawsuitWithRocheMember2022-07-012022-07-310001145197podd:PatentInfringementLawsuitWithRocheMember2022-01-012022-12-310001145197podd:InLicensedIntellectualPropertyContractualDisputeMember2022-12-012022-12-310001145197us-gaap:DevelopedTechnologyRightsMemberpodd:InLicensedIntellectualPropertyContractualDisputeMember2022-12-012022-12-310001145197us-gaap:PatentsMemberpodd:InLicensedIntellectualPropertyContractualDisputeMember2022-12-012022-12-310001145197podd:InLicensedIntellectualPropertyContractualDisputeMemberus-gaap:SellingGeneralAndAdministrativeExpensesMember2022-01-012022-12-310001145197us-gaap:LetterOfCreditMember2022-12-310001145197us-gaap:LetterOfCreditMember2022-01-012022-12-310001145197srt:MinimumMemberus-gaap:LetterOfCreditMember2022-12-310001145197srt:MaximumMemberus-gaap:LetterOfCreditMember2022-12-310001145197podd:FeesToFormerEuropeanDistributorMember2018-07-012019-06-300001145197podd:FeesToFormerEuropeanDistributorMember2020-12-012020-12-310001145197podd:A2017PlanMember2017-05-310001145197podd:A2017PlanMember2022-12-310001145197us-gaap:CostOfSalesMember2022-01-012022-12-310001145197us-gaap:CostOfSalesMember2021-01-012021-12-310001145197us-gaap:CostOfSalesMember2020-01-012020-12-310001145197us-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-12-310001145197us-gaap:ResearchAndDevelopmentExpenseMember2021-01-012021-12-310001145197us-gaap:ResearchAndDevelopmentExpenseMember2020-01-012020-12-310001145197us-gaap:SellingGeneralAndAdministrativeExpensesMember2022-01-012022-12-310001145197us-gaap:SellingGeneralAndAdministrativeExpensesMember2021-01-012021-12-310001145197us-gaap:SellingGeneralAndAdministrativeExpensesMember2020-01-012020-12-310001145197us-gaap:EmployeeStockOptionMember2022-01-012022-12-310001145197us-gaap:EmployeeStockOptionMember2021-01-012021-12-310001145197us-gaap:EmployeeStockOptionMember2020-01-012020-12-310001145197us-gaap:EmployeeStockOptionMembersrt:MinimumMember2021-01-012021-12-310001145197srt:MaximumMemberus-gaap:EmployeeStockOptionMember2021-01-012021-12-310001145197us-gaap:EmployeeStockOptionMember2022-12-310001145197us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-12-310001145197us-gaap:RestrictedStockUnitsRSUMember2021-12-310001145197us-gaap:RestrictedStockUnitsRSUMember2022-12-310001145197us-gaap:RestrictedStockUnitsRSUMember2021-01-012021-12-310001145197us-gaap:RestrictedStockUnitsRSUMember2020-01-012020-12-310001145197us-gaap:PerformanceSharesMember2022-01-012022-12-310001145197us-gaap:PerformanceSharesMember2021-12-310001145197us-gaap:PerformanceSharesMember2022-12-310001145197us-gaap:PerformanceSharesMemberus-gaap:ShareBasedCompensationAwardTrancheOneMember2022-01-012022-12-310001145197us-gaap:PerformanceSharesMember2021-01-012021-12-310001145197us-gaap:PerformanceSharesMember2020-01-012020-12-310001145197podd:EmployeeStockPurchasePlansMemberus-gaap:EmployeeStockMember2022-12-310001145197podd:EmployeeStockPurchasePlansMemberus-gaap:EmployeeStockMember2022-01-012022-12-310001145197podd:EmployeeStockPurchasePlansMemberus-gaap:EmployeeStockMember2021-01-012021-12-310001145197podd:EmployeeStockPurchasePlansMemberus-gaap:EmployeeStockMember2020-01-012020-12-310001145197us-gaap:EmployeeStockMember2022-01-012022-12-310001145197us-gaap:EmployeeStockMember2021-01-012021-12-310001145197us-gaap:EmployeeStockMember2020-01-012020-12-310001145197us-gaap:EmployeeStockMember2022-12-310001145197us-gaap:AccumulatedTranslationAdjustmentMember2019-12-310001145197us-gaap:AccumulatedNetUnrealizedInvestmentGainLossMember2019-12-310001145197us-gaap:AccumulatedGainLossNetCashFlowHedgeParentMember2019-12-310001145197us-gaap:AccumulatedTranslationAdjustmentMember2020-01-012020-12-310001145197us-gaap:AccumulatedNetUnrealizedInvestmentGainLossMember2020-01-012020-12-310001145197us-gaap:AccumulatedGainLossNetCashFlowHedgeParentMember2020-01-012020-12-310001145197us-gaap:AccumulatedTranslationAdjustmentMember2020-12-310001145197us-gaap:AccumulatedNetUnrealizedInvestmentGainLossMember2020-12-310001145197us-gaap:AccumulatedGainLossNetCashFlowHedgeParentMember2020-12-310001145197us-gaap:AccumulatedTranslationAdjustmentMember2021-01-012021-12-310001145197us-gaap:AccumulatedNetUnrealizedInvestmentGainLossMember2021-01-012021-12-310001145197us-gaap:AccumulatedGainLossNetCashFlowHedgeParentMember2021-01-012021-12-310001145197us-gaap:AccumulatedTranslationAdjustmentMember2021-12-310001145197us-gaap:AccumulatedNetUnrealizedInvestmentGainLossMember2021-12-310001145197us-gaap:AccumulatedGainLossNetCashFlowHedgeParentMember2021-12-310001145197us-gaap:AccumulatedTranslationAdjustmentMember2022-01-012022-12-310001145197us-gaap:AccumulatedNetUnrealizedInvestmentGainLossMember2022-01-012022-12-310001145197us-gaap:AccumulatedGainLossNetCashFlowHedgeParentMember2022-01-012022-12-310001145197us-gaap:AccumulatedTranslationAdjustmentMember2022-12-310001145197us-gaap:AccumulatedNetUnrealizedInvestmentGainLossMember2022-12-310001145197us-gaap:AccumulatedGainLossNetCashFlowHedgeParentMember2022-12-310001145197us-gaap:DomesticCountryMember2022-12-310001145197us-gaap:DomesticCountryMember2021-12-310001145197us-gaap:StateAndLocalJurisdictionMember2022-12-310001145197us-gaap:StateAndLocalJurisdictionMember2021-12-310001145197us-gaap:ForeignCountryMember2022-12-310001145197us-gaap:ForeignCountryMember2021-12-310001145197us-gaap:EmployeeStockOptionMember2022-01-012022-12-310001145197us-gaap:EmployeeStockOptionMember2021-01-012021-12-310001145197us-gaap:EmployeeStockOptionMember2020-01-012020-12-310001145197us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-12-310001145197us-gaap:RestrictedStockUnitsRSUMember2021-01-012021-12-310001145197us-gaap:RestrictedStockUnitsRSUMember2020-01-012020-12-310001145197podd:ConvertibleSeniorNotes0375Memberus-gaap:ConvertibleDebtSecuritiesMember2022-01-012022-12-310001145197podd:ConvertibleSeniorNotes0375Memberus-gaap:ConvertibleDebtSecuritiesMember2021-01-012021-12-310001145197podd:ConvertibleSeniorNotes0375Memberus-gaap:ConvertibleDebtSecuritiesMember2020-01-012020-12-310001145197podd:ConvertibleSeniorNotes1.375Memberus-gaap:ConvertibleDebtSecuritiesMember2022-01-012022-12-310001145197podd:ConvertibleSeniorNotes1.375Memberus-gaap:ConvertibleDebtSecuritiesMember2021-01-012021-12-310001145197podd:ConvertibleSeniorNotes1.375Memberus-gaap:ConvertibleDebtSecuritiesMember2020-01-012020-12-310001145197us-gaap:SubsequentEventMember2023-02-012023-02-230001145197podd:ReserveForRebatesMember2021-12-310001145197podd:ReserveForRebatesMember2022-01-012022-12-310001145197podd:ReserveForRebatesMember2022-12-310001145197us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember2021-12-310001145197us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember2022-01-012022-12-310001145197us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember2022-12-310001145197podd:ReserveForRebatesMember2020-12-310001145197podd:ReserveForRebatesMember2021-01-012021-12-310001145197us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember2020-12-310001145197us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember2021-01-012021-12-310001145197podd:ReserveForRebatesMember2019-12-310001145197podd:ReserveForRebatesMember2020-01-012020-12-310001145197us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember2019-12-310001145197us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember2020-01-012020-12-31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
| | | | | | | | |
| ☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the fiscal year ended | December 31, 2022 |
| | | | | |
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the transition period from to |
Commission File Number 001-33462
INSULET CORPORATION
(Exact name of Registrant as specified in its charter)
| | | | | | | | | | | | | | | | | |
| Delaware | | 04-3523891 |
| (State or Other Jurisdiction of Incorporation or Organization) | | (I.R.S. Employer Identification No.) |
| | | | |
| 100 Nagog Park | Acton | Massachusetts | | 01720 |
| (Address of Principal Executive Offices)
| | (Zip Code) |
Registrant’s telephone number, including area code: (978) 600-7000
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered |
| Common Stock, $0.001 Par Value Per Share | PODD | The NASDAQ Stock Market, LLC |
| | |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No ¨
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x
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. Yes x 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 and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | | | | |
| Large accelerated filer | x | | Non-accelerated filer | ¨ |
| | | | |
| Accelerated filer | ¨ | | Smaller reporting company | ☐ |
| | | | |
| | | Emerging growth company | ☐ |
If an emerging growth company, 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. ¨
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value of the common stock held by non-affiliates of the registrant computed by reference to the last reported sale price of the Common Stock as reported on The NASDAQ Global Market on June 30, 2022 was approximately $15.1 billion.
The number of shares of common stock outstanding as of February 16, 2023 was 69,542,257.
DOCUMENTS INCORPORATED BY REFERENCE
The registrant intends to file a proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, 2022. Portions of such proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K.
TABLE OF CONTENTS
| | | | | | | | |
| | |
| Item 1 | | |
| Item 1A | | |
| Item 1B | | |
| Item 2 | | |
| Item 3 | | |
| Item 4 | | |
| | |
| | |
| Item 5 | | |
| Item 6 | | |
| Item 7 | | |
| Item 7A | | |
| Item 8 | | |
| Item 9 | | |
| Item 9A | | |
| Item 9B | | |
| | |
| | |
| Item 10 | | |
| Item 11 | | |
| Item 12 | | |
| Item 13 | | |
| Item 14 | | |
| | |
| | |
| Item 15 | | |
| Item 16 | | |
| | |
| | |
PART I
Item 1. Business
Overview
Insulet Corporation (“we” or the “Company”) is primarily engaged in the development, manufacture and sale of its proprietary Omnipod® System, a continuous insulin delivery system for people with insulin-dependent diabetes, which we have been selling since 2005. The Omnipod System includes: the Omnipod Insulin Management System (“Classic Omnipod”), the Omnipod DASH® Insulin Management System (“Omnipod DASH”), and the Omnipod® 5 Automated Insulin Delivery System (“Omnipod 5”). In addition, substantially all of our Drug Delivery revenue consists of sales of pods to Amgen for use in the Neulasta® Onpro® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy.
Market Opportunity: Management of Diabetes
Diabetes is a chronic, life-threatening disease for which there is no known cure. It is caused by the body’s inability to produce or effectively utilize the hormone insulin, which prevents the body from adequately regulating blood glucose levels. Glucose, the primary source of energy for cells, must be maintained at certain concentrations in the blood in order to permit optimal cell function and health. In people with diabetes, blood glucose levels fluctuate between very high levels, a condition known as hyperglycemia, and very low levels, a condition called hypoglycemia. Hyperglycemia can lead to serious short-term complications, such as confusion, vomiting, dehydration, and loss of consciousness and long-term complications, such as blindness, kidney disease, nervous system disease, occlusive vascular diseases, stroke, cardiovascular disease, or death. Hypoglycemia can lead to confusion, loss of consciousness, or death.
Diabetes is typically classified as either type 1 or type 2:
•Type 1 diabetes is characterized by the body’s nearly complete inability to produce insulin. It is frequently diagnosed during childhood or adolescence. Individuals with type 1 diabetes require daily insulin therapy to survive. We estimate that approximately five million people have type 1 diabetes in the countries we currently serve.
•Type 2 diabetes, the more common form, is characterized by the body’s inability to either properly utilize insulin or produce enough insulin. Historically, type 2 diabetes has occurred in later adulthood, but its incidence is increasing among the younger population, due primarily to increasing obesity. Initially, many people with type 2 diabetes attempt to manage their diabetes with improvements in diet, exercise, and/or oral medications. As their diabetes advances, some individuals progress to multiple drug therapies, which often include insulin therapy. We estimate that approximately six million people have insulin-intensive type 2 diabetes in the countries we currently serve.
We estimate that approximately 40% of the type 1 diabetes population in the United States and even less of the international type 1 diabetes population use insulin pump therapy. An even smaller portion of the U.S. and international insulin-intensive type 2 diabetes population use insulin pump therapy. We believe these factors present a significant available market for the Omnipod System globally.
Throughout this Annual Report on Form 10-K, we refer to both type 1 diabetes and insulin-intensive type 2 diabetes as insulin-dependent diabetes.
Diabetes Management Challenges
Diabetes is often frustrating and difficult for people to manage. Blood glucose levels can be affected by the carbohydrate and fat content of meals, exercise, stress, illness, impending illness, hormonal releases, variability in insulin absorption, and changes in the effects of insulin on the body. For people with insulin-dependent diabetes, many corrections, consisting of the administration of additional insulin or ingestion of additional carbohydrates, are needed throughout the day in order to maintain blood glucose levels within normal ranges. Achieving this result can be very difficult with multiple daily injections of insulin. Individuals with diabetes attempting to control their blood glucose levels tightly to prevent the long-term complications associated with fluctuations in blood glucose levels are at greater risk for overcorrection and hypoglycemia. As a result, many people have difficulty managing their diabetes. Additionally, the time spent managing fluctuations in blood glucose levels and the fear associated with hypoglycemia can be incredibly stressful for individuals with diabetes and their families.
Current Insulin Therapy
People with insulin-dependent diabetes need a continuous supply of insulin, known as basal insulin, to provide for background metabolic needs. In addition to basal insulin, people with insulin-dependent diabetes require supplemental insulin, known as bolus insulin, to compensate for carbohydrates ingested during meals or snacks or for a high blood glucose level caused by other physiological reasons. There are two primary types of insulin therapy practiced today: multiple daily injections (“MDI”) therapy using syringes or insulin pens and pump therapy using insulin pumps.
MDI therapy involves the administration of fast-acting insulin before meals (bolus) to lower blood glucose levels to a healthy range. MDI therapy may also require a separate injection of a long-acting (basal) insulin, to control glucose levels between meals; typically, once or twice per day. By comparison, insulin pump therapy uses only fast-acting insulin to fulfill both mealtime (bolus) and background (basal) requirements. Insulin pump therapy allows individuals to customize their bolus and basal insulin doses to meet their insulin needs throughout the day and is intended to more closely resemble the physiologic function of a healthy pancreas.
Insulin pumps perform continuous subcutaneous insulin infusion and typically use a programmable device and an infusion set to administer insulin into the body. Insulin pump therapy has been shown to provide numerous advantages relative to MDI therapy. For example, insulin pump therapy eliminates individual insulin injections, delivers insulin more accurately and precisely than injections, often improves HbA1c (a common measure of blood glucose levels) over time, provides greater flexibility with meals, exercise, and daily schedules, and can reduce severe low blood glucose levels. We believe that these advantages, along with technological advancements, including the use of continuous glucose monitoring technology and automated insulin device (“AID”) algorithms, and increased awareness of insulin pump therapy will continue to generate demand for insulin pump devices.
Our Solution: The Omnipod System
The Omnipod System is a continuous insulin delivery system that provides all the benefits of insulin pump therapy in a unique way. We believe the Omnipod System’s innovative proprietary design and differentiated features allow people with insulin-dependent diabetes to live their lives and manage their diabetes, with unprecedented freedom, comfort, convenience, and ease.