0001104506false--12-312023Q1http://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#ProductMemberhttp://fasb.org/us-gaap/2022#AccountingStandardsUpdate202006Memberhttp://fasb.org/us-gaap/2022#AccountingStandardsUpdate202006Member25.53840.025538430.76920.030769200011045062023-01-012023-03-3100011045062023-05-01xbrli:shares00011045062023-03-31iso4217:USD00011045062022-12-31iso4217:USDxbrli:shares00011045062022-01-012022-03-310001104506us-gaap:CommonStockMember2021-12-310001104506us-gaap:AdditionalPaidInCapitalMember2021-12-310001104506us-gaap:RetainedEarningsMember2021-12-310001104506us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-12-3100011045062021-12-3100011045062021-01-012021-12-310001104506us-gaap:AdditionalPaidInCapitalMembersrt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2021-12-310001104506us-gaap:RetainedEarningsMembersrt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2021-12-310001104506srt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2021-12-310001104506us-gaap:RetainedEarningsMember2022-01-012022-03-310001104506us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-01-012022-03-310001104506us-gaap:CommonStockMember2022-01-012022-03-310001104506us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-310001104506us-gaap:CommonStockMember2022-03-310001104506us-gaap:AdditionalPaidInCapitalMember2022-03-310001104506us-gaap:RetainedEarningsMember2022-03-310001104506us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-03-3100011045062022-03-310001104506us-gaap:CommonStockMember2022-12-310001104506us-gaap:AdditionalPaidInCapitalMember2022-12-310001104506us-gaap:RetainedEarningsMember2022-12-310001104506us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-12-310001104506us-gaap:RetainedEarningsMember2023-01-012023-03-310001104506us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-01-012023-03-310001104506us-gaap:CommonStockMember2023-01-012023-03-310001104506us-gaap:AdditionalPaidInCapitalMember2023-01-012023-03-310001104506us-gaap:CommonStockMember2023-03-310001104506us-gaap:AdditionalPaidInCapitalMember2023-03-310001104506us-gaap:RetainedEarningsMember2023-03-310001104506us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-03-310001104506us-gaap:SalesRevenueProductLineMemberus-gaap:CustomerConcentrationRiskMemberinsm:CustomerAMember2023-01-012023-03-31xbrli:pure0001104506us-gaap:SalesRevenueProductLineMemberus-gaap:CustomerConcentrationRiskMemberinsm:CustomerAMember2022-01-012022-03-310001104506us-gaap:SalesRevenueProductLineMemberus-gaap:CustomerConcentrationRiskMemberinsm:CustomerBMember2023-01-012023-03-310001104506us-gaap:SalesRevenueProductLineMemberus-gaap:CustomerConcentrationRiskMemberinsm:CustomerBMember2022-01-012022-03-310001104506us-gaap:SalesRevenueProductLineMemberus-gaap:CustomerConcentrationRiskMemberinsm:CustomerCMember2023-01-012023-03-310001104506us-gaap:SalesRevenueProductLineMemberus-gaap:CustomerConcentrationRiskMemberinsm:CustomerCMember2022-01-012022-03-31insm:reportingUnit0001104506us-gaap:EmployeeStockOptionMember2023-01-012023-03-310001104506us-gaap:EmployeeStockOptionMember2022-01-012022-03-310001104506us-gaap:RestrictedStockUnitsRSUMember2023-01-012023-03-310001104506us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-03-310001104506us-gaap:PerformanceSharesMember2023-01-012023-03-310001104506us-gaap:PerformanceSharesMember2022-01-012022-03-310001104506us-gaap:EmployeeStockOptionMember2023-01-012023-03-310001104506us-gaap:EmployeeStockOptionMember2022-01-012022-03-310001104506us-gaap:RestrictedStockUnitsRSUMember2023-01-012023-03-310001104506us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-03-310001104506us-gaap:PerformanceSharesMember2023-01-012023-03-310001104506us-gaap:PerformanceSharesMember2022-01-012022-03-310001104506us-gaap:ConvertibleDebtSecuritiesMember2023-01-012023-03-310001104506us-gaap:ConvertibleDebtSecuritiesMember2022-01-012022-03-310001104506us-gaap:AccountingStandardsUpdate202006Membersrt:CumulativeEffectPeriodOfAdoptionAdjustmentMember2022-01-010001104506us-gaap:AccountingStandardsUpdate202006Member2022-01-010001104506us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CarryingReportedAmountFairValueDisclosureMember2023-03-310001104506us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2023-03-310001104506us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2023-03-310001104506us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2023-03-310001104506us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CarryingReportedAmountFairValueDisclosureMember2022-12-310001104506us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2022-12-310001104506us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2022-12-310001104506us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:EstimateOfFairValueFairValueDisclosureMember2022-12-310001104506us-gaap:ShareBasedCompensationAwardTrancheTwoMemberinsm:MotusBiosciencesIncMember2021-08-012021-08-310001104506us-gaap:ShareBasedCompensationAwardTrancheOneMemberinsm:MotusBiosciencesIncMember2021-08-012021-08-310001104506us-gaap:ShareBasedCompensationAwardTrancheThreeMemberinsm:MotusBiosciencesIncMember2021-08-012021-08-310001104506insm:MotusBiosciencesIncMember2022-07-012022-09-300001104506insm:AccruedLiabilitiesCurrentMember2023-03-310001104506us-gaap:OtherNoncurrentLiabilitiesMember2023-03-310001104506us-gaap:FairValueInputsLevel2Memberus-gaap:MeasurementInputSharePriceMember2023-03-310001104506insm:MotusBiosciencesIncMember2021-08-042021-08-040001104506insm:AlgaeneXIncMember2021-08-012021-08-310001104506insm:MeasurementInputProbabilityOfSuccessMember2023-03-310001104506insm:MotusBiosciencesIncMember2023-03-31insm:numberOfSales0001104506us-gaap:FairValueInputsLevel3Memberinsm:MotusBiosciencesIncMember2023-03-310001104506us-gaap:OtherNoncurrentLiabilitiesMemberus-gaap:FairValueInputsLevel3Memberinsm:MotusBiosciencesIncMember2023-03-310001104506insm:DevelopmentAndRegulatoryMilestonesMember2023-03-310001104506insm:DevelopmentAndRegulatoryMilestonesMembersrt:MinimumMemberus-gaap:FairValueInputsLevel3Memberinsm:MeasurementInputProbabilityOfSuccessMember2023-03-310001104506insm:DevelopmentAndRegulatoryMilestonesMemberus-gaap:FairValueInputsLevel3Memberinsm:MeasurementInputProbabilityOfSuccessMembersrt:MaximumMember2023-03-310001104506insm:PriorityReviewVoucherMilestoneMember2023-03-310001104506us-gaap:FairValueInputsLevel3Memberinsm:MeasurementInputProbabilityOfSuccessMemberinsm:PriorityReviewVoucherMilestoneMember2023-03-310001104506us-gaap:FairValueInputsLevel3Memberus-gaap:MeasurementInputDiscountRateMemberinsm:PriorityReviewVoucherMilestoneMember2023-03-310001104506us-gaap:FairValueInputsLevel2Member2021-12-310001104506us-gaap:FairValueInputsLevel3Member2021-12-310001104506us-gaap:FairValueInputsLevel2Member2022-01-012022-03-310001104506us-gaap:FairValueInputsLevel3Member2022-01-012022-03-310001104506us-gaap:FairValueInputsLevel2Member2022-03-310001104506us-gaap:FairValueInputsLevel3Member2022-03-310001104506us-gaap:FairValueInputsLevel2Member2022-12-310001104506us-gaap:FairValueInputsLevel3Member2022-12-310001104506us-gaap:FairValueInputsLevel2Member2023-01-012023-03-310001104506us-gaap:FairValueInputsLevel3Member2023-01-012023-03-310001104506us-gaap:FairValueInputsLevel2Member2023-03-310001104506us-gaap:FairValueInputsLevel3Member2023-03-310001104506insm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Memberus-gaap:ConvertibleNotesPayableMember2023-03-310001104506us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:EstimateOfFairValueFairValueDisclosureMemberinsm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Member2023-03-310001104506insm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2023-03-310001104506us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:EstimateOfFairValueFairValueDisclosureMemberinsm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Member2023-03-310001104506country:US2023-01-012023-03-310001104506country:US2022-01-012022-03-310001104506country:JP2023-01-012023-03-310001104506country:JP2022-01-012022-03-310001104506insm:EuropeAndTheRestOfTheWorldMember2023-01-012023-03-310001104506insm:EuropeAndTheRestOfTheWorldMember2022-01-012022-03-310001104506insm:AcquiredResearchAndDevelopmentMember2022-12-310001104506insm:AcquiredResearchAndDevelopmentMember2023-01-012023-03-310001104506insm:AcquiredResearchAndDevelopmentMember2023-03-310001104506us-gaap:InProcessResearchAndDevelopmentMember2022-12-310001104506us-gaap:InProcessResearchAndDevelopmentMember2023-01-012023-03-310001104506us-gaap:InProcessResearchAndDevelopmentMember2023-03-310001104506us-gaap:LicensingAgreementsMember2022-12-310001104506us-gaap:LicensingAgreementsMember2023-01-012023-03-310001104506us-gaap:LicensingAgreementsMember2023-03-310001104506insm:AcquiredResearchAndDevelopmentMember2021-12-310001104506insm:AcquiredResearchAndDevelopmentMember2022-01-012022-03-310001104506insm:AcquiredResearchAndDevelopmentMember2022-03-310001104506us-gaap:InProcessResearchAndDevelopmentMember2021-12-310001104506us-gaap:InProcessResearchAndDevelopmentMember2022-01-012022-03-310001104506us-gaap:InProcessResearchAndDevelopmentMember2022-03-310001104506us-gaap:LicensingAgreementsMember2021-12-310001104506us-gaap:LicensingAgreementsMember2022-01-012022-03-310001104506us-gaap:LicensingAgreementsMember2022-03-310001104506us-gaap:EquipmentMember2023-01-012023-03-310001104506us-gaap:EquipmentMember2023-03-310001104506us-gaap:EquipmentMember2022-12-310001104506us-gaap:FurnitureAndFixturesMember2023-01-012023-03-310001104506us-gaap:FurnitureAndFixturesMember2023-03-310001104506us-gaap:FurnitureAndFixturesMember2022-12-310001104506insm:ComputerHardwareAndSoftwareMembersrt:MinimumMember2023-01-012023-03-310001104506insm:ComputerHardwareAndSoftwareMembersrt:MaximumMember2023-01-012023-03-310001104506insm:ComputerHardwareAndSoftwareMember2023-03-310001104506insm:ComputerHardwareAndSoftwareMember2022-12-310001104506us-gaap:OfficeEquipmentMember2023-01-012023-03-310001104506us-gaap:OfficeEquipmentMember2023-03-310001104506us-gaap:OfficeEquipmentMember2022-12-310001104506insm:ManufacturingEquipmentMember2023-01-012023-03-310001104506insm:ManufacturingEquipmentMember2023-03-310001104506insm:ManufacturingEquipmentMember2022-12-310001104506us-gaap:LeaseholdImprovementsMembersrt:MinimumMember2023-01-012023-03-310001104506us-gaap:LeaseholdImprovementsMembersrt:MaximumMember2023-01-012023-03-310001104506us-gaap:LeaseholdImprovementsMember2023-03-310001104506us-gaap:LeaseholdImprovementsMember2022-12-310001104506us-gaap:ConstructionInProgressMember2023-03-310001104506us-gaap:ConstructionInProgressMember2022-12-310001104506srt:MinimumMember2023-01-012023-03-310001104506srt:MaximumMember2023-01-012023-03-3100011045062022-01-012022-12-310001104506us-gaap:ConvertibleNotesPayableMember2023-03-310001104506us-gaap:ConvertibleNotesPayableMember2022-12-310001104506insm:TermLoanMember2023-03-310001104506insm:TermLoanMember2022-12-310001104506insm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Memberus-gaap:ConvertibleNotesPayableMember2021-05-310001104506insm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Memberus-gaap:ConvertibleNotesPayableMember2021-05-012021-05-310001104506insm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2018-01-310001104506insm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2018-01-012018-01-310001104506insm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2021-05-310001104506insm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2021-05-012021-05-310001104506insm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Member2018-01-012018-01-310001104506insm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Member2018-01-012018-01-310001104506insm:DebtInstrumentConversionTermOneMemberinsm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2018-01-012018-01-31insm:day0001104506insm:DebtInstrumentConversionTermOneMemberinsm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Memberus-gaap:ConvertibleNotesPayableMember2021-05-012021-05-310001104506insm:DebtInstrumentConversionTermTwoMemberinsm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Memberus-gaap:ConvertibleNotesPayableMember2021-05-012021-05-310001104506insm:DebtInstrumentConversionTermTwoMemberinsm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2018-01-012018-01-310001104506insm:DebtInstrumentConversionTermThreeMemberinsm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2018-01-012018-01-310001104506insm:DebtInstrumentConversionTermThreeMemberinsm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Memberus-gaap:ConvertibleNotesPayableMember2021-05-012021-05-310001104506insm:DebtInstrumentConversionTermFourMemberinsm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2018-01-012018-01-310001104506insm:DebtInstrumentConversionTermFourMemberinsm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Memberus-gaap:ConvertibleNotesPayableMember2021-05-012021-05-310001104506us-gaap:ConvertibleNotesPayableMember2018-01-310001104506us-gaap:ConvertibleNotesPayableMember2021-05-310001104506insm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Memberus-gaap:ConvertibleNotesPayableMember2023-01-012023-03-310001104506insm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Memberus-gaap:ConvertibleNotesPayableMember2023-01-012023-03-310001104506us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:CarryingReportedAmountFairValueDisclosureMemberinsm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Member2023-03-310001104506us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:CarryingReportedAmountFairValueDisclosureMemberinsm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Member2023-03-310001104506us-gaap:SecuredDebtMemberinsm:TermLoanMember2022-10-310001104506insm:SecuredOvernightFinancingRateSOFRMemberus-gaap:SecuredDebtMemberinsm:TermLoanMember2022-10-012022-10-310001104506insm:SecuredOvernightFinancingRateSOFRMemberinsm:VariableRateComponentTwoMemberus-gaap:SecuredDebtMemberinsm:TermLoanMember2022-10-012022-10-310001104506us-gaap:SecuredDebtMemberinsm:TermLoanMember2022-10-012022-10-310001104506us-gaap:SecuredDebtMemberinsm:TermLoanMember2023-03-310001104506us-gaap:SecuredDebtMemberinsm:TermLoanMember2022-12-310001104506us-gaap:ConvertibleDebtMember2023-01-012023-03-310001104506us-gaap:ConvertibleDebtMember2022-01-012022-03-310001104506insm:TermLoanMember2023-01-012023-03-310001104506insm:TermLoanMember2022-01-012022-03-310001104506us-gaap:RoyaltyAgreementsMember2023-01-012023-03-310001104506us-gaap:RoyaltyAgreementsMember2022-01-012022-03-310001104506insm:OnePointSevenFivePercentConvertibleSeniorNoteDue2025Member2021-05-012021-05-310001104506insm:ZeroPointSevenFivePercentConvertibleSeniorNoteDue2028Member2021-05-012021-05-310001104506us-gaap:SecuredDebtMemberus-gaap:RoyaltyAgreementsMember2022-10-012022-10-310001104506us-gaap:SubsequentEventMemberinsm:ARIKAYCEGlobalNetSalesMemberus-gaap:RoyaltyAgreementsMember2025-09-010001104506insm:ARIKAYCEGlobalNetSalesMemberus-gaap:RoyaltyAgreementsMember2022-10-310001104506insm:BrensocatibGlobalNetSalesMemberus-gaap:SubsequentEventMemberus-gaap:RoyaltyAgreementsMember2025-09-010001104506us-gaap:SecuredDebtMemberus-gaap:RoyaltyAgreementsMember2022-10-310001104506us-gaap:RoyaltyAgreementsMember2022-10-310001104506us-gaap:RoyaltyAgreementsMembersrt:MaximumMember2022-10-310001104506us-gaap:SecuredDebtMemberus-gaap:RoyaltyAgreementsMember2022-12-310001104506us-gaap:SecuredDebtMemberus-gaap:RoyaltyAgreementsMember2023-01-012023-03-310001104506us-gaap:SecuredDebtMemberus-gaap:RoyaltyAgreementsMember2023-03-310001104506us-gaap:EmployeeStockOptionMember2023-03-310001104506us-gaap:RestrictedStockUnitsRSUMember2023-03-310001104506us-gaap:PerformanceSharesMember2023-03-310001104506us-gaap:ConvertibleNotesPayableMember2023-03-310001104506insm:MotusBiosciencesIncMember2021-07-012021-09-300001104506insm:VertuisBioIncMember2023-01-310001104506insm:VertuisBioIncMember2023-01-012023-01-310001104506insm:VertuisBioIncMember2023-03-310001104506insm:PublicStockOfferingMember2022-10-012022-10-3100011045062022-10-3100011045062022-10-012022-10-310001104506insm:PublicStockOfferingMember2021-04-012021-06-300001104506us-gaap:OverAllotmentOptionMember2021-04-012021-06-3000011045062021-06-3000011045062021-04-012021-06-300001104506insm:AtTheMarketAgreementMember2021-01-012021-03-310001104506insm:AtTheMarketAgreementMember2023-03-310001104506insm:AtTheMarketAgreementMember2022-07-012022-09-300001104506insm:A2019IncentivePlanThirdAmendmentMember2019-05-160001104506insm:A2019IncentivePlanThirdAmendmentMember2020-05-122020-05-120001104506insm:A2019IncentivePlanSecondAmendmentMember2021-05-122021-05-120001104506insm:A2019IncentivePlanThirdAmendmentMember2022-05-112022-05-110001104506insm:AmendedAndRestatedPlanMember2022-05-112022-05-110001104506insm:A2019IncentivePlanThirdAmendmentMember2023-03-310001104506insm:EmployeeStockPurchasePlan2018Member2018-05-150001104506insm:EmployeeStockPurchasePlan2018Member2018-05-152018-05-150001104506us-gaap:ResearchAndDevelopmentExpenseMemberinsm:StockOptionsAndRestrictedStockUnitsMember2023-01-012023-03-310001104506us-gaap:ResearchAndDevelopmentExpenseMemberinsm:StockOptionsAndRestrictedStockUnitsMember2022-01-012022-03-310001104506us-gaap:GeneralAndAdministrativeExpenseMemberinsm:StockOptionsAndRestrictedStockUnitsMember2023-01-012023-03-310001104506us-gaap:GeneralAndAdministrativeExpenseMemberinsm:StockOptionsAndRestrictedStockUnitsMember2022-01-012022-03-310001104506insm:StockOptionsAndRestrictedStockUnitsMember2023-01-012023-03-310001104506insm:StockOptionsAndRestrictedStockUnitsMember2022-01-012022-03-310001104506insm:MilestoneEvent1Memberinsm:VertuisBioIncMember2023-01-310001104506insm:MilestoneEvent2Memberinsm:VertuisBioIncMember2023-01-310001104506insm:MilestoneEvent3Memberinsm:VertuisBioIncMember2023-01-310001104506us-gaap:CommonStockMemberinsm:VertuisBioIncMember2023-01-012023-01-310001104506insm:MotusBiosciencesIncMember2021-08-040001104506insm:AlgaeneXIncMember2021-08-310001104506insm:MotusBiosciencesIncMember2021-08-3100011045062021-05-242021-05-24insm:days0001104506insm:MotusBiosciencesIncAndAlgaeneXIncMember2021-08-012021-08-31

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2023
OR
☐    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 000-30739
INSMED INCORPORATED
(Exact name of registrant as specified in its charter)
Virginia54-1972729
(State or other jurisdiction of incorporation or organization)(I.R.S. employer identification no.)
700 US Highway 202/206,
 
Bridgewater, New Jersey
08807
(Address of principal executive offices)(Zip Code)
(908) 977-9900
(Registrant’s telephone number including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section12(b) of the Act:
Title of each classTrading symbolsName of each exchange on which registered
Common stock, par value $0.01 per shareINSMNasdaq Global Select Market
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 such files). Yes x No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth 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
Accelerated filer o
Non-accelerated filer o
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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No x
As of May 1, 2023, there were 136,432,799 shares of the registrant’s common stock outstanding.



INSMED INCORPORATED
FORM 10-Q
FOR THE QUARTER ENDED MARCH 31, 2023
 
INDEX
 
 
 
 
 
 
Unless the context otherwise indicates, references in this Form 10-Q to “Insmed Incorporated” refers to Insmed Incorporated, a Virginia corporation, and the “Company,” “Insmed,” “we,” “us” and “our” refer to Insmed Incorporated together with its consolidated subsidiaries. INSMED, PULMOVANCE, ARIKARES and ARIKAYCE are trademarks of Insmed Incorporated. This Form 10-Q also contains trademarks of third parties. Each trademark of another company appearing in this Form 10-Q is the property of its owner.

2

PART I.  FINANCIAL INFORMATION
ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS
INSMED INCORPORATED
Consolidated Balance Sheets
(in thousands, except par value and share data)
As ofAs of
March 31, 2023December 31, 2022
 (unaudited) 
Assets  
Current assets:  
Cash and cash equivalents$968,907 $1,074,036 
Marketable securities29,774 74,244 
Accounts receivable30,523 29,713 
Inventory71,317 69,922 
Prepaid expenses and other current assets28,542 25,468 
Total current assets1,129,063 1,273,383 
Fixed assets, net59,556 56,491 
Finance lease right-of-use assets23,019 23,697 
Operating lease right-of-use assets21,154 21,894 
Intangibles, net67,493 68,756 
Goodwill136,110 136,110 
Other assets81,322 76,104 
Total assets$1,517,717 $1,656,435 
Liabilities and shareholders’ equity  
Current liabilities:  
Accounts payable and accrued liabilities$179,005 $182,117 
Finance lease liabilities2,158 1,217 
Operating lease liabilities6,821 6,909 
Total current liabilities187,984 190,243 
Debt, long-term1,132,188 1,125,250 
Royalty financing agreement150,173 148,015 
Contingent consideration38,600 51,100 
Finance lease liabilities, long-term29,015 29,636 
Operating lease liabilities, long-term14,534 14,853 
Other long-term liabilities9,876 9,387 
Total liabilities1,562,370 1,568,484 
Shareholders’ equity:  
Common stock, $0.01 par value; 500,000,000 authorized shares, 136,429,216 and 135,653,731 issued and outstanding shares at March 31, 2023 and December 31, 2022, respectively
1,364 1,357 
Additional paid-in capital2,809,242 2,782,416 
Accumulated deficit(2,856,342)(2,696,578)
Accumulated other comprehensive income1,083 756 
Total shareholders’ (deficit) equity(44,653)87,951 
Total liabilities and shareholders’ equity$1,517,717 $1,656,435 
See accompanying notes to consolidated financial statements
3

INSMED INCORPORATED
Consolidated Statements of Comprehensive Loss (unaudited)
(in thousands, except per share data)
 Three Months Ended March 31,
 20232022
Product revenues, net$65,214 $53,107 
Operating expenses:  
Cost of product revenues (excluding amortization of intangible assets)13,830 12,191 
Research and development127,865 84,356 
Selling, general and administrative79,914 56,748 
Amortization of intangible assets1,263 1,263 
Change in fair value of deferred and contingent consideration liabilities(9,500)(11,618)
Total operating expenses213,372 142,940 
Operating loss(148,158)(89,833)
Investment income10,524 137 
Interest expense(20,003)(3,291)
Change in fair value of interest rate swap(1,533)— 
Other expense, net(111)(1,249)
Loss before income taxes(159,281)(94,236)
Provision for income taxes483 385 
Net loss$(159,764)$(94,621)
Basic and diluted net loss per share$(1.17)$(0.80)
Weighted average basic and diluted common shares outstanding
136,355 118,929 
Net loss$(159,764)$(94,621)
Other comprehensive income (loss):  
Foreign currency translation loss(171)(494)
Unrealized gain (loss) on marketable securities498 (704)
Total comprehensive loss$(159,437)$(95,819)
    
See accompanying notes to consolidated financial statements

4

INSMED INCORPORATED
Consolidated Statements of Shareholders' Equity (unaudited)
(in thousands)
 Common StockAdditional
Paid-in
Capital		Accumulated
Deficit		Accumulated
Other
Comprehensive
Income (Loss)		Total
SharesAmount
Balance at December 31, 2021118,738 $1,187 $2,673,556 $(2,265,243)$968 $410,468 
Cumulative impact of ASU adoption 2020-06
(264,609)50,199 (214,410)
Comprehensive loss:
Net loss(94,621)(94,621)
Other comprehensive loss(1,198)(1,198)
Exercise of stock options and ESPP shares450 4 6,812 6,816 
Issuance of common stock for vesting of RSUs158 2 2 
Stock compensation expense12,823 12,823 
Balance at March 31, 2022119,346 $1,193 $2,428,582 $(2,309,665)$(230)$119,880 
Balance at December 31, 2022135,654 $1,357 $2,782,416 $(2,696,578)$756 $87,951 
Comprehensive loss:
Net loss(159,764)(159,764)
Other comprehensive income327 327 
Exercise of stock options and ESPP shares82 1 1,138 1,139 
Issuance of common stock for vesting of RSUs193 1 1 
Issuance of common stock for asset acquisition 500 5 9,245 9,250 
Stock compensation expense16,443 16,443 
Balance at March 31, 2023136,429 $1,364 $2,809,242 $(2,856,342)$1,083 $(44,653)
See accompanying notes to consolidated financial statements
5

INSMED INCORPORATED
Consolidated Statements of Cash Flows (unaudited)
(in thousands)
 Three Months Ended March 31,
 20232022
Operating activities  
Net loss$(159,764)$(94,621)
Adjustments to reconcile net loss to net cash used in operating activities:  
Depreciation1,248 1,286 
Amortization of intangible assets1,263 1,263 
Stock-based compensation expense16,443 12,823 
Amortization of debt issuance costs1,724 822 
Paid-in-kind interest capitalized5,456 — 
Royalty financing non-cash interest expense2,615 — 
Finance lease amortization expense678 729 
Non-cash operating lease expense2,491 2,369 
Change in fair value of deferred and contingent consideration liabilities(9,500)(11,618)
Change in fair value of interest rate swap1,533 — 
Vertuis acquisition10,250 — 
Changes in operating assets and liabilities:  
Accounts receivable(860)(1,798)
Inventory(1,187)2,240 
Prepaid expenses and other current assets(3,199)(2,752)
Other assets(5,231)(6,289)
Accounts payable and accrued liabilities(8,841)13,363 
Other liabilities(1,422)(22,978)
Net cash used in operating activities(146,303)(105,161)
Investing activities  
Purchase of fixed assets(3,398)(1,701)
Purchase of marketable securities— (99,706)
Maturities of marketable securities45,000 — 
Net cash provided by (used in) investing activities41,602 (101,407)
Financing activities  
Proceeds from exercise of stock options and ESPP1,139 6,818 
Payments of finance lease principal(320)(359)
Payment of debt issuance costs(1,218)— 
Net cash (used in) provided by financing activities(399)6,459 
Effect of exchange rates on cash and cash equivalents(29)(969)
Net decrease in cash and cash equivalents(105,129)(201,078)
Cash and cash equivalents at beginning of period1,074,036 716,782 
Cash and cash equivalents at end of period$968,907 $515,704 
Supplemental disclosures of cash flow information:  
Cash paid for interest$11,589 $2,375 
Cash paid for income taxes$1,004 $635 
See accompanying notes to consolidated financial statements
6
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. The Company and Basis of Presentation
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. The Company's first commercial product, ARIKAYCE, is approved in the United States (US) as ARIKAYCE® (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the European Commission (EC) approved ARIKAYCE for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis (CF). In March 2021, Japan's Ministry of Health, Labour and Welfare (MHLW) approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. NTM lung disease caused by MAC (which the Company refers to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. The Company's clinical-stage pipeline includes brensocatib, treprostinil palmitil inhalation powder (TPIP) and early-stage research programs. Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), which the Company is developing for the treatment of patients with bronchiectasis, CF and other neutrophil-mediated diseases, including chronic rhinosinusitis without nasal polyps (CRSsNP). TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). The Company is also advancing its early-stage research programs encompassing a wide range of technologies and modalities, including gene therapy, artificial intelligence-driven protein engineering, and protein manufacturing.
The Company was incorporated in the Commonwealth of Virginia on November 29, 1999 and its principal executive offices are located in Bridgewater, New Jersey. The Company has legal entities in the US, France, Germany, Ireland, Italy, the Netherlands, Switzerland, the UK, and Japan.
The accompanying unaudited interim consolidated financial statements have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the US for complete consolidated financial statements are not included herein. The unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2022.
     The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. The unaudited interim consolidated financial information presented herein reflects all normal adjustments that are, in the opinion of management, necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. All intercompany transactions and balances have been eliminated in consolidation.
     The Company had $968.9 million in cash and cash equivalents and $29.8 million of marketable securities as of March 31, 2023 and reported a net loss of $159.8 million for the three months ended March 31, 2023. The Company has funded its operations through public offerings of equity securities, debt financings and revenue interest financings. The Company expects to continue to incur consolidated operating losses, including losses in its US and certain international entities, while funding research and development (R&D) activities for ARIKAYCE, brensocatib, TPIP and its other pipeline programs, continuing commercialization and regulatory activities for ARIKAYCE and pre-commercial, regulatory and, if approved, commercialization activities for brensocatib, and funding other general and administrative activities.
The Company expects its future cash requirements to be substantial. While the Company currently has sufficient funds to meet its financial needs for at least the next 12 months, the Company may raise additional capital in the future to fund its operations, its ongoing commercialization and clinical trial activities, and its future product candidates, and to develop, acquire, in-license or co-promote other products or product candidates, including those that address orphan or rare diseases. The source, timing and availability of any future financing or other transaction will depend principally upon continued progress in the Company’s commercial, regulatory and development activities. Any future financing will also be contingent upon market conditions. If the Company is unable to obtain sufficient additional funds when required, the Company may be forced to delay, restrict or eliminate all or a portion of its development programs or commercialization efforts.
7
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. Summary of Significant Accounting Policies
The following are the required interim disclosure updates to the Company's significant accounting policies described in Note 2 of the notes to the consolidated financial statements in the Company's Annual Report on Form 10-K for the year ended December 31, 2022:
Use of Estimates - The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and on various other assumptions. The amounts of assets and liabilities reported in the Company's balance sheets and the amounts of revenues and expenses reported for each period presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for revenue allowances, stock-based compensation, income taxes, loss contingencies, acquisition related intangibles including in process research and development (IPR&D) and goodwill, fair value of contingent consideration, and accounting for research and development costs. Actual results could differ from those estimates.
Concentration of Credit Risk - Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company places its cash equivalents with high credit-quality financial institutions and may invest its short-term investments in US treasury securities, mutual funds and government agency bonds. The Company has established guidelines relative to credit ratings and maturities that seek to maintain safety and liquidity.
The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The Company does not currently have a material allowance for uncollectible trade receivables. The following table presents the percentage of gross product revenue represented by the Company's three largest customers as of the three months ended March 31, 2023.
March 31,
20232022
Customer A36%36%
Customer B36%32%
Customer C17%17%
The Company relies on third-party manufacturers and suppliers for manufacturing and supply of its products. The inability of the suppliers or manufacturers to fulfill supply requirements of the Company could materially impact future operating results. A change in the relationship with the suppliers or manufacturers, or an adverse change in their business, could materially impact future operating results.
Inventory and Cost of Product Revenues (excluding amortization of intangible assets) - Inventory is stated at the lower of cost and net realizable value and consists of raw materials, work-in-process and finished goods. The Company periodically reviews inventory for expiry and obsolescence and, if necessary, writes down accordingly. If quality specifications are not met during the manufacturing process, such inventory is written off to cost of product revenues (excluding amortization of intangible assets) in the period identified.
Cost of product revenues (excluding amortization of intangible assets) consist primarily of direct and indirect costs related to the manufacturing of ARIKAYCE sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs, in addition to royalty expenses and revenue-based milestone payments. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. See Note 5 - Inventory for further details. Inventory used for clinical development purposes is expensed to R&D expense when consumed.
Acquisitions - The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create
8
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
 2. Summary of Significant Accounting Policies (Continued)
outputs, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets and liabilities, and non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with Accounting Standards Codification (ASC) 805, Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired.
The consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a particular event or events. The obligations for such contingent consideration payments are recorded at fair value on the acquisition date. The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, are recognized as a gain or loss and recorded within change in the fair value of deferred and contingent consideration liabilities in the consolidated statements of comprehensive loss.
If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from the assets’ carrying amounts on the acquiring entity’s books. Consideration transferred that is non-cash will be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of the assets acquired and liabilities assumed, whichever is more reliably measurable. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values.
Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration is paid or becomes payable (unless the contingent consideration meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired). Upon recognition of the contingent consideration payment, the amount is included in the cost of the acquired asset or group of assets. See Note 16 - Acquisitions for further information.
Indefinite-lived intangible assets - Indefinite-lived intangible assets consist of IPR&D. IPR&D acquired directly in a transaction other than a business combination is capitalized if the projects will be further developed or have an alternative future use; otherwise, they are expensed. The fair values of IPR&D project assets acquired in business combinations are capitalized. The Company generally utilizes the Multi-Period Excess Earning Method to determine the estimated fair value of the IPR&D assets acquired in a business combination. The projections used in this valuation approach are based on many factors, such as relevant market size, patent protection, and expected pricing and industry trends. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate. Intangible assets with indefinite lives, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. However, an entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that an indefinite-lived intangible asset’s fair value is less than its carrying amount. The indefinite-lived intangible asset impairment test consists of a one-step analysis that compares the fair value of the intangible asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. The Company considers many factors in evaluating whether the value of its intangible assets with indefinite lives may not be recoverable, including, but not limited to, expected growth rates, the cost of equity and debt capital, general economic conditions, the Company’s outlook and market performance of the Company’s industry and recent and forecasted financial performance The Company performs a qualitative test for its indefinite-lived intangible assets annually as of October 1. See Note 6 - Intangibles, Net and Goodwill for further details.
Finite-lived Intangible Assets - Finite-lived intangible assets are measured at their respective fair values on the date they were recorded. The fair values assigned to the Company's intangible assets are based on reasonable estimates and assumptions given available facts and circumstances. See Note 6 - Intangibles, Net and Goodwill for further details.
9
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
 2. Summary of Significant Accounting Policies (Continued)
Impairment Assessment - The Company reviews the recoverability of its finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment include negative clinical trial results, a significant decrease in the market price of the asset, or a significant adverse change in legal factors or the manner in which the asset is used. If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, the Company measures the amount of the impairment by comparing the carrying value of the assets to the fair value of the assets.
Goodwill - Goodwill represents the amount of consideration paid in excess of the fair value of net assets acquired as a result of the Company’s business acquisitions accounted for using the acquisition method of accounting. Goodwill is not amortized and is subject to impairment testing at a reporting unit level on an annual basis or when a triggering event occurs that may indicate the carrying value of the goodwill is impaired. An entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that the fair value of the reporting unit is less than its carrying amount. As of March 31, 2023, the Company continues to operate as one reporting unit. The Company will perform its next annual impairment testing for goodwill as of October 1, 2023. See Note 6 - Intangibles, Net and Goodwill for further details.
Leases - A lease is a contract, or part of a contract, that conveys the right to control the use of explicitly or implicitly identified property, plant or equipment in exchange for consideration. Control of an asset is conveyed to the Company if the Company obtains the right to obtain substantially all of the economic benefits of the asset or the right to direct the use of the asset. The Company recognizes right-of-use (ROU) assets and lease liabilities at the lease commencement date based on the present value of future, fixed lease payments over the term of the arrangement. ROU assets are amortized on a straight-line basis over the term of the lease or are amortized based on consumption, if this approach is more representative of the pattern in which benefit is expected to be derived from the underlying asset. Lease liabilities accrete to yield and are reduced at the time when the lease payment is payable to the vendor. Variable lease payments are recognized at the time when the event giving rise to the payment occurs and are recognized in the consolidated statements of comprehensive loss in the same line item as expenses arising from fixed lease payments.
Leases are measured at present value using the rate implicit in the lease or, if the implicit rate is not determinable, the lessee's implicit borrowing rate. As the implicit rate is not typically available, the Company uses its implicit borrowing rate based on the information available at the lease commencement date to determine the present value of future lease payments. The implicit borrowing rate approximates the rate the Company would pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments. See Note 9 - Leases for further details.
Foreign Currency - The Company has operations in the US, France, Germany, Ireland, Italy, the Netherlands, Switzerland, the UK, and Japan. The results of the Company's non-US dollar based functional currency operations are translated to US dollars at the average exchange rates during the period. Assets and liabilities are translated at the exchange rate prevailing at the balance sheet date. Equity is translated at the prevailing exchange rate at the date of the equity transaction. Translation adjustments are included in shareholders' (deficit) equity, as a component of accumulated other comprehensive income.
The Company realizes foreign currency transaction gains and losses in the normal course of business based on movements in the applicable exchange rates. These gains and losses are included as a component of other expense, net.
Debt Issuance Costs - Debt issuance costs are amortized to interest expense using the effective interest rate method over the term of the debt. Unamortized debt issuance costs paid to the lender and third parties are reflected as a discount to the debt in the consolidated balance sheets. Unamortized debt issuance costs associated with extinguished debt are expensed in the period of the extinguishment.
Synthetic Royalty Financing Agreement - In October 2022, the Company entered into a revenue interest purchase agreement (the Royalty Financing Agreement) with OrbiMed Royalty & Credit Opportunities IV, LP (OrbiMed). The fair value of the Royalty Financing Agreement at the time of the transaction was based on the Company’s estimates of future royalties expected to be paid to OrbiMed over the life of the arrangement, which was determined using forecasts from market data sources, which are considered Level 3 inputs. This liability is being amortized using the effective interest method over the life of the arrangement, in accordance ASC 470, Debt and ASC 835, Interest. The Company is utilizing the prospective method to account for subsequent changes in the estimated future payments to be made to OrbiMed and will update the effective interest rate on a quarterly basis. See Note - 11 Royalty Financing Agreement for further details.
10
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
 2. Summary of Significant Accounting Policies (Continued)
Derivatives - In the normal course of business, the Company is exposed to the effects of interest rate changes. The Company may enter into derivative instruments, including interest rate swaps and caps, to manage or hedge interest rate risk. Derivative instruments are recorded at fair value on the balance sheet date. The Company has not elected hedge accounting treatment for the changes in the fair value of derivatives. Changes in the fair value of derivatives are recorded each period and are included in change in fair value of interest rate swap in the consolidated statements of comprehensive loss and consolidated statements of cash flows.
Net Loss Per Share - Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares and other dilutive securities outstanding during the period. Potentially dilutive securities from stock options, restricted stock (RS), restricted stock units (RSUs), performance stock units (PSUs) and convertible debt securities would be anti-dilutive as the Company incurred a net loss. Potentially dilutive common shares resulting from the assumed exercise of outstanding stock options and from the assumed conversion of the Company's convertible notes are determined based on the treasury stock method.
The following table sets forth the reconciliation of the weighted average number of common shares used to compute basic and diluted net loss per share for the three months ended March 31, 2023 and 2022:
 
 Three Months Ended March 31,
 20232022
 
Numerator:  
Net loss$(159,764)$(94,621)
Denominator:  
Weighted average common shares used in calculation of basic net loss per share:136,355 118,929 
Effect of dilutive securities:  
Common stock options— — 
RS and RSUs— — 
PSUs— — 
Convertible debt securities— — 
Weighted average common shares outstanding used in calculation of diluted net loss per share136,355 118,929 
Net loss per share:  
Basic and diluted$(1.17)$(0.80)
The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of March 31, 2023 and 2022, respectively, as their effect would have been anti-dilutive (in thousands):
 
March 31,
 20232022
Common stock options19,156 15,282 
Unvested restricted stock and RSUs2,058 1,163 
PSUs671 679 
Convertible debt securities23,438 23,438 
Recently Adopted Accounting Pronouncements - In August 2020, the Financial Accounting Standards Board issued ASU 2020-06, Debt — Accounting for Convertible Instruments, to reduce the complexity associated with applying GAAP to certain financial instruments with characteristics of liabilities and equity. For convertible instruments, the number of accounting models for convertible debt instruments is reduced, which results in fewer embedded conversion features being separately recognized from the host contract. Only convertible instruments that meet the definition of a derivative or are issued with substantial premiums will continue to be subject to the separation models. ASU 2020-06 is effective for fiscal years beginning
11
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
 2. Summary of Significant Accounting Policies (Continued)
after December 15, 2021. A modified retrospective and a fully retrospective transition method are both permitted. The Company transitioned using the modified retrospective method. The impact of adopting ASU 2020-06 on January 1, 2022 resulted in an opening balance sheet adjustment increasing debt by approximately $221.9 million, increasing issuance costs classified to debt by $6.1 million, decreasing the deferred tax liability by $1.4 million, and increasing retained earnings by $50.2 million, with an offsetting reduction to additional paid-in-capital of $264.6 million, net of tax.

3. Fair Value Measurements
The Company categorizes its financial assets and liabilities measured and reported at fair value in the financial statements on a recurring basis based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels, which are directly related to the amount of subjectivity associated with the inputs used to determine the fair value of financial assets and liabilities, are as follows:
•Level 1 — Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
•Level 2 — Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
•Level 3 — Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
Each major category of financial assets and liabilities measured at fair value on a recurring basis is categorized based upon the lowest level of significant input to the valuations. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Financial instruments in Level 1 generally include US treasuries and mutual funds listed in active markets. The Company's cash and cash equivalents permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions.
The following table shows assets and liabilities that are measured at fair value on a recurring basis and their carrying value (in millions):
March 31, 2023
Fair Value
Carrying ValueLevel 1Level 2Level 3
Assets
Cash and cash equivalents$968.9 $968.9 $— $— 
Marketable securities$29.8 $29.8 $— $— 
Collateral for interest rate swap$5.0 $5.0 $— $— 
Liabilities
Interest rate swap$3.1 $— $3.1 $— 
Deferred consideration$6.2 $— $6.2 $— 
Contingent consideration$49.8 $— $— $49.8 
12
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Fair Value Measurements (Continued)
December 31, 2022
Fair Value
Carrying ValueLevel 1Level 2Level 3
Assets
Cash and cash equivalents$1,074.0 $1,074.0 $— $— 
Marketable securities$74.2 $74.2 $— $— 
Collateral for interest rate swap$5.0 $5.0 $— $— 
Liabilities
Interest rate swap$1.5 $— $1.5 $— 
Deferred consideration$7.4 $— $7.4 $— 
Contingent consideration$58.1 $— $— $58.1 
The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. The collateral for interest rate swap and the interest rate swap are recorded in other assets and accounts payable and accrued liabilities, respectively, in the consolidated balance sheet as of March 31, 2023 and December 31, 2022. The collateral for interest rate swap is cash, a Level 1 asset. The interest rate swap is a Level 2 liability as it uses observable inputs other than quoted market prices in an active market. There were no transfers in or out of Level 1, Level 2 or Level 3 during the three months ended March 31, 2023.
As of March 31, 2023, the Company held $29.8 million of current available-for-sale securities, net of an unrealized loss of $0.2 million recorded in accumulated other comprehensive income. Marketable securities maturing in one year or less are classified as current assets and marketable securities maturing in more than one year are classified as non-current assets.
The Company reviews the status of each security quarterly to determine whether an other-than-temporary impairment has occurred. In making its determination, the Company considers a number of factors, including: (1) the significance of the decline; (2) whether the security was rated below investment grade; (3) failure of the issuer to make scheduled interest or principal payments; and (4) the Company's ability and intent to retain the investment for a sufficient period of time for it to recover. The Company has determined that there were no other-than-temporary impairments during the three months ended March 31, 2023.
Deferred Consideration
The deferred consideration arose from the acquisitions of Motus Biosciences, Inc. (Motus) and AlgaeneX, Inc. (AlgaeneX) (the Business Acquisition) in August 2021. The Company is obligated to issue to Motus equityholders an aggregate of 184,433 shares of the Company’s common stock on each of the first, second and third anniversaries of the closing date, subject to certain reductions. During August 2022, the Company fulfilled the payment due on the first anniversary of the closing date by issuing 171,427 shares of the Company's common stock, after certain reductions. A valuation of the deferred consideration is performed quarterly with gains and losses included within change in fair value of deferred and contingent consideration liabilities in the consolidated statements of comprehensive loss. As the deferred consideration is settled in shares, there is no discount rate applied in the fair value calculation.
The deferred consideration has been classified as a Level 2 recurring liability as its valuation utilizes an input, the Insmed share price, which is a directly observable input at the measurement date and for the duration of the liabilities' anticipated lives. Deferred consideration expected to be settled within 12 months or less is classified as a current liability within accounts payable and accrued liabilities. As of March 31, 2023, the fair value of deferred consideration included in accounts payable and accrued liabilities was $3.1 million. Deferred consideration expected to be settled in more than 12 months is classified as a non-current liability within other long-term liabilities. As of March 31, 2023, the fair value of deferred consideration included in other long-term liabilities was $3.1 million.
The following observable input was used in the valuation of the deferred consideration as of March 31, 2023:
13
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Fair Value Measurements (Continued)
Fair Value as of March 31, 2023 (in millions)
Observable InputInput Value
Deferred consideration
$6.2
Insmed share price as of March 31, 2023
$17.05
Contingent Consideration
The contingent consideration liabilities arose from the Business Acquisition in August 2021 (Note 16). The contingent consideration liabilities consist of developmental and regulatory milestones, a priority review voucher milestone and net sales milestones. Upon the achievement of certain development and regulatory milestone events, the Company is obligated to issue to Motus equityholders up to 5,348,572 shares in the aggregate and AlgaeneX equityholders up to 368,867 shares in the aggregate. The fair value of the development and regulatory milestones are estimated utilizing a probability-adjusted approach. At March 31, 2023, the weighted average probability of success was 42%. The development and regulatory milestones will be settled in shares of the Company's common stock. As such, there is no discount rate applied in the fair value calculation.
If the Company were to receive a priority review voucher, the Company is obligated to pay to the Motus equityholders a portion of the value of the priority review voucher, subject to certain reductions. The potential payout will be either 50% of the after tax net proceeds received by the Company from a sale of the priority review voucher or 50% of the average of the sales prices for the last three publicly disclosed priority review voucher sales, less certain adjustments. The fair value of the priority review voucher milestone is estimated utilizing a probability-adjusted discounted cash flow approach. This obligation will be settled in cash.
The contingent consideration liabilities for net sales milestones were valued using an option pricing model with Monte Carlo simulation. As of March 31, 2023, the fair value of these net sales milestones were deemed immaterial to the overall fair value of the contingent consideration.
The contingent consideration liabilities have been classified as a Level 3 recurring liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the inputs to the valuation approach, the estimated fair value could be significantly different than the fair value the Company determined. Contingent consideration expected to be settled within 12 months or less is classified as a current liability within accounts payable and accrued liabilities. As of March 31, 2023, the fair value of contingent consideration included in accounts payable and accrued liabilities was $11.2 million. Contingent consideration expected to be settled in more than twelve months is classified as a non-current liability. As of March 31, 2023, the fair value of non-current contingent consideration was $38.6 million.
Contingent consideration liabilities expected to be settled in more than twelve months are classified as a non-current liability in the consolidated balance sheet. A valuation of the contingent consideration liabilities is performed quarterly with gains and losses included within change in fair value of contingent consideration liabilities in the consolidated statements of comprehensive loss.
The following significant unobservable inputs were used in the valuation of the development and regulatory milestones and the priority review voucher milestone as of March 31, 2023:

Fair Value as of March 31, 2023 (in millions)
Valuation TechniqueUnobservable InputsValues
Development and regulatory milestones$41.2Probability-adjustedProbabilities of success
14% - 97%
Priority review voucher milestone$6.2Probability-adjusted discounted cash flowProbability of success
16.4%
Discount rate
12.3%
The following table is a summary of the changes in the fair value of the Company's valuations for the deferred and contingent consideration liabilities for the three months ended March 31, 2023 and 2022 (in thousands):
14
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Fair Value Measurements (Continued)
Deferred Consideration (Level 2 Liabilities)Contingent Consideration
 (Level 3 Liabilities)
Balance as of December 31, 2021$14,931 $75,668 
Additions— — 
Change in Fair Value(2,070)(9,548)
Payments— — 
Balance as of March 31, 2022$12,861 $66,120 
Balance as of December 31, 2022$7,400 $58,100 
Additions— — 
Change in Fair Value(1,200)(8,300)
Payments— — 
Balance as of March 31, 2023$6,200 $49,800 
Convertible Notes
The fair value of the convertible notes, which differs from their carrying value, is influenced by interest rates, the Company's stock price and stock price volatility, and is determined by prices for the convertible notes observed in market trading which are Level 2 inputs.
The estimated fair value of the liability component of the Company's 0.75% convertible senior notes due 2028 (the 2028 Convertible Notes) (categorized as a Level 2 liability for fair value measurement purposes) as of March 31, 2023 was $446.5 million, determined using current market factors and the ability of the Company to obtain debt on comparable terms to the 2028 Convertible Notes.
The estimated fair value of the liability component of the Company's 1.75% convertible senior notes due 2025 (the 2025 Convertible Notes) (categorized as a Level 2 liability for fair value measurement purposes) as of March 31, 2023 was $202.3 million, determined using current market factors and the ability of the Company to obtain debt on comparable terms to the 2025 Convertible Notes. See Note 10 - Debt for further details on the Company's convertible notes.

4. Product Revenues, Net
In accordance with ASC 606, Revenue from Contracts with Customers, the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for the goods or services provided. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when or as the entity satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract to determine which are performance obligations and to assess whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. For all contracts that fall into the scope of ASC 606, the Company has identified one performance obligation: the sale of ARIKAYCE to its customers. The Company has not incurred or capitalized any incremental costs associated with obtaining contracts with customers.
Product revenues, net consist of net sales of ARIKAYCE. The Company's customers in the US include specialty pharmacies and specialty distributors. In December 2020, the Company began recognizing product revenue from commercial sales of ARIKAYCE in Europe. In July 2021, the Company began recognizing product revenue from commercial sales of ARIKAYCE in Japan. Globally, product revenues are recognized once the Company performs and satisfies all five steps of the revenue recognition criteria mentioned above.
The following table presents a summary of the Company's product revenues, net, by geographic location for the three months ended March 31, 2023 and 2022 (in thousands):
15
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. Product Revenues, Net (Continued)
Three Months Ended March 31,
20232022
US$49,067 $40,782 
Japan13,156 10,676 
Europe and rest of world2,991 1,649 
  Total product revenues, net$65,214 $53,107 
Revenue is recorded at net selling price (transaction price), which includes estimates of variable consideration for which reserves are established for (a) customer credits, such as invoice discounts for prompt pay, (b) estimated government rebates, such as Medicaid and Medicare Part D reimbursements, and estimated managed care rebates, (c) estimated chargebacks, and (d) estimated costs of co-payment assistance. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (prompt pay discounts and chargebacks), prepaid expenses (co-payment assistance), or as a current liability (rebates). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company's historical experience, current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.
Customer credits: Certain of the Company's customers are offered various forms of consideration, including prompt payment discounts. The payment terms for sales to specialty pharmacies and specialty distributors for prompt payment discounts are based on contractual rates agreed with the respective specialty pharmacies and distributors. The Company anticipates that its customers will earn these discounts and, therefore, deducts the full amount of these discounts from total gross product revenues at the time such revenues are recognized.
Rebates: The Company contracts with certain government agencies and managed care organizations, or collectively, third-party payors, so that ARIKAYCE will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accounts payable and accrued liabilities on the consolidated balance sheets. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company's contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payor mix, and (iv) information obtained from the Company's specialty pharmacies.
Chargebacks: Chargebacks are discounts that occur when certain contracted customers, currently public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase directly from the Company's specialty distributor. Contracted customers generally purchase the product at a discounted price and the specialty distributor, in turn, charges back to the Company the difference between the price the specialty distributor initially paid and the discounted price paid by the contracted customers. The Company estimates chargebacks provided to the specialty distributor and deducts these estimated amounts from gross product revenues, and from accounts receivable, at the time revenues are recognized.
Co-payment assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program in order to establish accruals for co-payment assistance. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue. The Company adjusts its accruals for co-pay assistance based on actual redemption activity and estimates of future redemptions related to sales in the current period.
If any, or all, of the Company's actual experience varies from its estimates, the Company may need to adjust prior period accruals, affecting revenue in the period of adjustment.
16
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. Product Revenues, Net (Continued)
The Company also recognizes revenue related to various early access programs (EAPs) in Europe. EAPs are intended to make products available on a named patient basis before they are commercially available in accordance with local regulations.
5. Inventory
As of March 31, 2023 and December 31, 2022, the Company's inventory balance consists of the following (in thousands):
March 31, 2023December 31, 2022
Raw materials$24,553 $27,245 
Work-in-process20,166 22,460 
Finished goods26,598 20,217 
$71,317 $69,922 
The Company has not recorded any significant inventory write-downs. The Company currently uses a limited number of third-party contract manufacturing organizations (CMOs) to produce its inventory.
6. Intangibles, Net and Goodwill
 Intangibles, Net
Finite-lived Intangible Assets
As of March 31, 2023, the Company's finite-lived intangible assets consisted of acquired ARIKAYCE R&D and the milestones paid to PARI for the license to use Lamira for the delivery of ARIKAYCE to patients as a result of the FDA and EC approvals of ARIKAYCE in September 2018 and October 2020, respectively. The Company began amortizing its acquired ARIKAYCE R&D and PARI milestones intangible assets in October 2018, over ARIKAYCE's initial regulatory exclusivity period of 12 years. Amortization of these assets during each of the next five years is estimated to be approximately $5.1 million per year.
Indefinite-lived Intangible Assets
As of March 31, 2023, the Company's indefinite-lived intangible assets consisted of acquired IPR&D from the Business Acquisition (Note 16). Indefinite-lived intangible assets are not amortized.
A rollforward of the Company's intangible assets for the three months ended March 31, 2023 and March 31, 2022 is as follows (in thousands):
Intangible AssetDecember 31, 2022AdditionsAmortization
March 31, 2023
Acquired ARIKAYCE R&D$37,588 $— $(1,212)$36,376 
Acquired IPR&D29,600 — — 29,600 
PARI milestones1,568 — (51)1,517 
$68,756 $— $(1,263)$67,493 
Intangible AssetDecember 31, 2021AdditionsAmortization
March 31, 2022
Acquired ARIKAYCE R&D$42,439 $— $(1,212)$41,227 
Acquired IPR&D29,600 — — 29,600 
PARI milestones1,770 — (51)1,719 
$73,809 $— $(1,263)$72,546 
Goodwill
The Company's goodwill balance of $136.1 million as of March 31, 2023 and December 31, 2022, resulted from the August 2021 Business Acquisition. See Note 16 - Acquisitions for further details. 
17
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
7. Fixed Assets, Net
Fixed assets are stated at cost and depreciated using the straight-line method, based on useful lives as follows (in thousands):
Estimated
Useful Life (years)		As of
Asset DescriptionMarch 31, 2023December 31, 2022
Lab equipment7$18,982 $16,403 
Furniture and fixtures76,428 6,428 
Computer hardware and software
3-5
5,695 5,227 
Office equipment789 89 
Manufacturing equipment71,336 1,203 
Leasehold improvements
2-10
37,042 37,057 
Construction in progress—30,662 29,529 
100,234 95,936 
Less: accumulated depreciation(40,678)(39,445)
$59,556 $56,491 

8. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consist of the following (in thousands):
As of
March 31, 2023December 31, 2022
Accounts payable and other accrued operating expenses$56,670 $50,461 
Accrued clinical trial expenses26,607 36,456 
Accrued professional fees18,242 14,403 
Accrued technical operation expenses6,734 3,345 
Accrued compensation and employee related costs18,867 32,040 
Accrued royalty and milestones payable6,165 4,710 
Accrued interest payable2,270 6,340 
Royalty revenue payable2,608 2,149 
Accrued sales allowances and related costs11,762 6,974 
Accrued France ATU reimbursement payable12,945 12,943 
Deferred and contingent consideration from Business Acquisition14,300 10,700 
Other accrued liabilities1,835 1,596 
$179,005 $182,117 
9. Leases
The Company's lease portfolio consists primarily of office and laboratory space, manufacturing facilities, research equipment and fleet vehicles. All of the Company's leases are classified as operating leases, except for the Company's leases of its corporate headquarters and a research facility in San Diego, which are classified as finance leases. The terms of the Company's lease agreements that have commenced range from less than one year to ten years, ten months. In its assessment of the term of each such lease, the Company has not included any options to extend or terminate the lease due to the absence of economic incentives in its lease agreements. Leases that qualify for treatment as a short-term lease are expensed as incurred. These short-term leases are not material to the Company's financial position. Furthermore, the Company does not separate lease
18
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
9. Leases (Continued)
and non-lease components for all classes of underlying assets. The Company's leases do not contain residual value guarantees and it does not sublease any of its leased assets.
The Company outsources its manufacturing operations to CMOs. Upon review of the agreements with its CMOs, the Company determined that these contracts contain embedded leases for dedicated manufacturing facilities. The Company obtains substantially all of the economic benefits from the use of the manufacturing facilities, the Company has the right to direct how and for what purpose the facility is used throughout the period of use, and the supplier does not have the right to change the operating instructions of the facility. The operating lease right-of-use assets and corresponding lease liabilities associated with the manufacturing facilities is the sum of the minimum guarantees over the life of the production contracts.
The Company also records variable consideration for variable lease payments in excess of fixed fees or minimum guarantees. Variable consideration related to the Company's leasing arrangements was $0.1 million and $0.1 million for the three months ended March 31, 2023 and 2022, respectively. Variable costs related to CMO manufacturing agreements are direct costs related to the manufacturing of ARIKAYCE and are capitalized within inventory in the Company's consolidated balance sheet, while the variable costs related to other leasing arrangements, not related to the manufacturing of ARIKAYCE, have been classified within operating expenses in the Company's consolidated statements of comprehensive loss.
The table below summarizes the supplemental non-cash disclosures of the Company's leases included in its consolidated financial statements (in thousands):
Three Months Ended March 31,
20232022
Finance right-of-use assets obtained in exchange for lease obligations$— $9,287 
Operating right-of-use assets obtained in exchange for lease obligations$1,751 $341 
In addition to the Company's lease agreements that have previously commenced and are reflected in the consolidated financial statements, the Company has entered into additional lease agreements that have not yet commenced. The Company entered into certain agreements with Patheon UK Limited (Patheon) related to increasing its long-term production capacity for ARIKAYCE commercial inventory. The Company has determined that these agreements with Patheon contain an embedded lease for the manufacturing facility and the specialized equipment contained therein. Costs of $42.5 million and $40.7 million incurred by the Company under these additional agreements have been classified within other assets in the Company's consolidated balance sheet as of March 31, 2023 and December 31, 2022, respectively. Upon the commencement date, prepaid costs and minimum guarantees specified in the agreement will be combined to establish an operating lease ROU asset and operating lease liability.
10. Debt
Debt, long-term consists of the following commitments as of March 31, 2023 and December 31, 2022 (in thousands):
As of
March 31, 2023December 31, 2022
Convertible notes$786,443 $785,621 
Term Loan345,745 339,629 
Debt, long-term$1,132,188 $1,125,250 
Convertible Notes
In May 2021, the Company completed an underwritten public offering of the 2028 Convertible Notes, in which the Company sold $575.0 million aggregate principal amount of the 2028 Convertible Notes, including the exercise in full of the underwriters' option to purchase an additional $75.0 million in aggregate principal amount of 2028 Convertible Notes. The Company's net proceeds from the offering, after deducting underwriting discounts and commissions and other offering expenses of $15.7 million, were approximately $559.3 million. The 2028 Convertible Notes bear interest payable semiannually in arrears on June 1 and December 1 of each year, beginning on December 1, 2021. The 2028 Convertible Notes mature on June 1, 2028, unless earlier converted, redeemed, or repurchased.
19
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Debt (Continued)
In January 2018, the Company completed an underwritten public offering of the 2025 Convertible Notes, in which the Company sold $450.0 million aggregate principal amount of the 2025 Convertible Notes, including the exercise in full of the underwriters' option to purchase an additional $50.0 million in aggregate principal amount of 2025 Convertible Notes. The Company's net proceeds from the offering, after deducting underwriting discounts and commissions and other offering expenses of $14.2 million, were approximately $435.8 million. The 2025 Convertible Notes bear interest payable semiannually in arrears on January 15 and July 15 of each year, beginning on July 15, 2018. The 2025 Convertible Notes mature on January 15, 2025, unless earlier converted, redeemed, or repurchased.
A portion of the net proceeds from the 2028 Convertible Notes was used to repurchase $225.0 million of the Company's outstanding 2025 Convertible Notes. The Company recorded a loss on early extinguishment of debt of $17.7 million, primarily related to the premium paid on extinguishment of a portion the 2025 Convertible Notes.
On or after October 15, 2024, until the close of business on the second scheduled trading day immediately preceding January 15, 2025, holders may convert their 2025 Convertible Notes at any time. The initial conversion rate for the 2025 Convertible Notes is 25.5384 shares of common stock per $1,000 principal amount of 2025 Convertible Notes (equivalent to an initial conversion price of approximately $39.16 per share of common stock). On or after March 1, 2028, until the close of business on the second scheduled trading day immediately preceding June 1, 2028, holders may convert their 2028 Convertible Notes at any time. The initial conversion rate for the 2028 Convertible Notes is 30.7692 shares of common stock per $1,000 principal amount of 2028 Convertible Notes (equivalent to an initial conversion price of approximately $32.50 per share of common stock). Upon conversion of either the 2025 Convertible Notes or the 2028 Convertible Notes, holders may receive cash, shares of the Company's common stock or a combination of cash and shares of the Company's common stock, at the Company's option. The conversion rates will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest.
Holders may convert their 2025 Convertible Notes prior to October 15, 2024 or their 2028 Convertible Notes prior to March 1, 2028, only under the following circumstances, subject to the conditions set forth in the applicable indenture: (i) during the five business day period immediately after any five consecutive trading day period (the measurement period) in which the trading price per $1,000 principal amount of the applicable series of convertible notes, as determined following a request by a holder of such convertible notes, for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the common stock and the conversion rate on such trading day, (ii) the Company elects to distribute to all or substantially all holders of the common stock (a) any rights, options or warrants (other than in connection with a stockholder rights plan for so long as the rights issued under such plan have not detached from the associated shares of common stock) entitling them, for a period of not more than 45 days from the declaration date for such distribution, to subscribe for or purchase shares of common stock at a price per share that is less than the average of the last reported sale prices of the common stock for the 10 consecutive trading day period ending on, and including, the trading day immediately preceding the declaration date for such distribution, or (b) the Company's assets, debt securities or rights to purchase securities of the Company, which distribution has a per share value, as reasonably determined by the board of directors, exceeding 10% of the last reported sale price of the common stock on the trading day immediately preceding the declaration date for such distribution, (iii) if a transaction or event that constitutes a fundamental change or a make-whole fundamental change occurs, or if the Company is a party to (a) a consolidation, merger, combination, statutory or binding share exchange or similar transaction, pursuant to which the common stock would be converted into, or exchanged for, cash, securities or other property or assets, or (b) any sale, conveyance, lease or other transfer or similar transaction in one transaction or a series of transactions of all or substantially all of the consolidated assets of the Company and its subsidiaries, taken as a whole, all or any portion of the applicable series of convertible notes may be surrendered by a holder for conversion at any time from or after the date that is 30 scheduled trading days prior to the anticipated effective date of the transaction, (iv) if during any calendar quarter commencing after the calendar quarter ending on March 31, 2018 or June 30, 2021 for the 2025 Convertible Notes and the 2028 Convertible Notes, respectively (and only during such calendar quarter), the last reported sale price of the common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day, or (v) if the Company sends a notice of redemption, a holder may surrender all or any portion of its convertible notes to which the notice of redemption relates for conversion at any time on or after the date the applicable notice of redemption was sent until the close of business on (a) the second business day immediately preceding the related redemption date or (b) if the Company fails to pay the redemption price on the redemption date as specified in such notice of redemption, such later date on which the redemption price is paid. To date, there have not been any holder-initiated redemption requests of either series of convertible notes.
20
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Debt (Continued)
Each series of convertible notes can be settled in cash, common stock, or a combination of cash and common stock at the Company's option, and thus, the Company determined the embedded conversion options in both series of convertible notes are not required to be separately accounted for as a derivative. However, since the convertible notes are within the scope of the accounting guidance for cash convertible instruments, the Company is required to separate each series of convertible notes into liability and equity components. The carrying amount of the liability component of each series of convertible notes as of the date of issuance was calculated by measuring the fair value of a similar liability that did not have an associated equity component. The fair value was based on data from readily available pricing sources that utilize market observable inputs and other characteristics for similar types of instruments. The carrying amount of the equity component representing the embedded conversion option for each series of convertible notes was determined by deducting the fair value of the liability component from the gross proceeds of the applicable convertible notes. The excess of the principal amount of the liability component over its carrying amount is amortized to interest expense over the expected life of a similar liability that does not have an associated equity component using the effective interest method. The equity component is not remeasured as long as it continues to meet the conditions for equity classification in the accounting guidance for contracts in an entity’s own equity. The fair value of the liability component of the 2025 Convertible Notes on the date of issuance was estimated at $309.1 million using an effective interest rate of 7.6% and, accordingly, the residual equity component on the date of issuance was $140.9 million. The fair value of the liability component of the 2028 Convertible Notes on the date of issuance was estimated at $371.6 million using an effective interest rate of 7.1% and, accordingly, the residual equity component on the date of issuance was $203.4 million. The respective discounts were amortized to interest expense over the term of the applicable series of convertible notes through December 31, 2021, prior to the adoption of ASU 2020-06. The 2025 Convertible Notes and 2028 Convertible Notes have remaining terms of approximately 1.79 years and 5.17 years, respectively.
The $563.3 million carrying value of the 2028 Convertible Notes as of March 31, 2023 excludes $11.7 million of unamortized debt issuance costs. The $223.2 million carrying value of the 2025 Convertible Notes as of March 31, 2023 excludes $1.8 million of unamortized debt issuance costs. The following table presents the carrying value of the Company's debt balance (in thousands):
 
As of
March 31, 2023December 31, 2022
Face value of outstanding convertible notes$800,000 $800,000 
Debt issuance costs, unamortized(13,557)(14,379)
Debt, long-term$786,443 $785,621 
Secured Senior Term Loan
In October 2022, the Company entered into a $350 million senior secured term loan agreement with Pharmakon Advisors LP, manager of the BioPharma Credit funds (the Term Loan). The Term Loan matures on October 19, 2027 and bears interest at a rate based upon the secured overnight financing rate (SOFR), subject to a SOFR floor of 2.5%, in addition to a margin of 7.75% per annum. Up to 50% of the interest payable during the first 24 months from the closing of the Term Loan may be paid-in-kind at the Company's election. If elected, paid-in-kind interest will be capitalized and added to the principal amount of the Term Loan. The Term Loan, including the paid-in-kind interest, will be repaid in eight equal quarterly payments starting in the 13th quarter following the closing of the Term Loan (i.e., the quarter ending March 31, 2026), except that the repayment start date may be extended at the Company's option for an additional four quarters, so that repayments start in the 17th quarter following the closing of the Term Loan, subject to the achievement of specified ARIKAYCE data thresholds and certain other conditions. During the three months ended March 31, 2023, paid-in-kind interest capitalized was $5.5 million. Net proceeds from the Term Loan, after deducting the lenders fees and deal expenses of $15.2 million, were $334.8 million.
The following table presents the carrying value of the Company’s Term Loan balance as of March 31, 2023 (in thousands):
21
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Debt (Continued)
As of
March 31, 2023December 31, 2022
Original Term Loan balance$350,000 $350,000 
Paid-in-kind interest capitalized9,621 4,165 
Term Loan issuance costs, unamortized(13,876)(14,536)
Term Loan$345,745 $339,629 
As of March 31, 2023, future principal repayments of debt for each of the years through maturity were as follows (in thousands):
 
Year Ending December 31: 
2023$— 
2024— 
2025225,000 
2026179,811 
2027179,810 
2028 and thereafter575,000 
 $1,159,621 
Interest Expense
Interest expense related to debt and finance leases for the three months ended March 31, 2023 and 2022 is as follows (in thousands):
Three Months Ended March 31,
20232022
Convertible debt contractual interest expense$2,063 $2,063 
Term Loan contractual interest expense10,911 — 
Royalty Financing Agreement non-cash interest expense4,764 — 
Amortization of debt issuance costs1,724 822 
Swap interest income(73)— 
   Total debt interest expense19,389 2,885 
Finance lease interest expense614 406 
   Total interest expense$20,003 $3,291 
11. Royalty Financing Agreement
In October 2022, the Company entered into the Royalty Financing Agreement with OrbiMed. Under the Royalty Financing Agreement, OrbiMed paid the Company $150 million in exchange for the right to receive, on a quarterly basis, royalties in an amount equal to 4% of ARIKAYCE global net sales prior to September 1, 2025 and 4.5% of ARIKAYCE global net sales on or after September 1, 2025, as well as 0.75% of brensocatib global net sales, if approved (the Revenue Interest Payments). In the event that OrbiMed has not received aggregate Revenue Interest Payments of at least $150 million on or prior to March 31, 2028, the Company must make a one-time payment to OrbiMed for the difference between the $150 million and the aggregated Revenue Interest Payments that have been paid. In addition, the royalty rate for ARIKAYCE will be increased beginning March 31, 2028 to the rate which would have resulted in aggregate Revenue Interest Payments as of March 31, 2028 equaling $150 million. The total Revenue Interest Payments payable by us to OrbiMed are capped at 1.8x of the purchase price or up to a maximum of 1.9x of the purchase price under certain conditions. Net proceeds from the Royalty Financing Agreement, after deducting the lenders fees and deal expenses of $3.8 million were, $146.2 million.
The fair value of the Royalty Financing Agreement at the time of the transaction was based on the Company’s estimates of future royalties expected to be paid to OrbiMed over the life of the arrangement, which was determined using forecasts from market data sources, which are considered Level 3 inputs. This liability is being amortized using the effective
22
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. Royalty Financing Agreement (Continued)
interest method over the life of the arrangement, in accordance ASC 470, Debt and ASC 835, Interest. The initial annual effective interest rate was determined to be 12.4%. The Company is utilizing the prospective method to account for subsequent changes in the estimated future payments to be made to OrbiMed and will update the effective interest rate on a quarterly basis. 
The following table presents a rollforward of the carrying value of the Company’s Royalty Financing Agreement balance for the three months ended March 31, 2023 (in thousands):

 Royalty financing agreement - beginning balance $148,015 
      Royalty revenue payments 2,017 
      Royalty revenue payable (2,608)
      Amortization of issuance costs134 
      Non-cash interest expense 2,615 
 Liability related to the sale of future royalties - ending balance $150,173 
Non-cash interest expense is recorded within interest expense in the consolidated statements of comprehensive loss. Royalty revenue payable is recorded within accounts payable and accrued liabilities on the consolidated balance sheet.
12. Shareholders' Equity
Common Stock — As of March 31, 2023, the Company had 500,000,000 shares of common stock authorized with a par value of $0.01 per share and 136,429,216 shares of common stock issued and outstanding. In addition, as of March 31, 2023, the Company had reserved 19,155,595 shares of common stock for issuance upon the exercise of outstanding stock options, 2,057,694 shares of common stock for issuance upon the vesting of RSUs and 671,112 shares for issuance upon the vesting of PSUs. The Company has also reserved 23,438,430 shares of common stock in the aggregate for issuance upon conversion of the 2025 Convertible Notes and 2028 Convertible Notes, subject to adjustment in accordance with the applicable indentures. In connection with the Business Acquisition, the Company reserved 9,406,112 shares of the Company’s common stock, subject to certain closing-related reductions. The shares of the Company’s common stock reserved in connection with the Motus acquisition were partly issued as acquisition consideration at closing and on the first anniversary of the closing date of the acquisition, and will also be issued upon the second and third anniversaries of the closing date of the acquisition and upon the achievement of certain development and regulatory milestone events, subject to certain reductions. The shares of the Company’s common stock reserved in connection with the AlgaeneX acquisition will be issued upon the achievement of a development milestone event, subject to certain reductions.
Of the 9,406,112 shares reserved, subject to certain closing-related reductions, the Company issued 2,889,367 shares of the Company's common stock in connection with the Business Acquisition (Note 16) in the third quarter of 2021, after certain closing-related deductions. In the third quarter of 2022, the Company issued 171,427 shares of the Company's common stock to fulfill the payment required to Motus equityholders on the first anniversary of the Business Acquisition.
In connection with the Company’s acquisition of Vertuis Bio, Inc. (Vertuis), the Company reserved 550,000 shares of the Company’s common stock, subject to future adjustment. An aggregate of 500,000 of the reserved shares were issued as acquisition consideration at closing. An additional $1 million of shares of common stock will be issued to Vertuis’ former stockholders on July 1, 2024, based on the share price on June 28, 2024. See Note 16 - Acquisitions for further details.
In October 2022, the Company completed an underwritten offering of 13,750,000 shares of the Company's common stock at a public offering price of $20.00 per share. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and offering expense of $16.2 million, were $258.8 million.
In the second quarter of 2021, the Company completed an underwritten public offering of 11,500,000 shares of the Company's common stock, including 1,500,000 shares issued pursuant to the exercise in full of the underwriters' option to purchase additional shares from the Company, at a public offering price of $25.00 per share. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and offering expenses of $17.5 million, were $270.1 million.
In the first quarter of 2021, the Company entered into a sales agreement with SVB Leerink LLC (now known as SVB Securities LLC) (SVB Securities), to sell shares of the Company's common stock, with aggregate gross sales proceeds of up to $250.0 million, from time to time, through an “at the market” equity offering program (the ATM program), under which SVB Securities acts as sales agent. During the third quarter of 2022, the Company issued and sold an aggregate of 1,289,995 shares of common stock through the ATM program at a weighted-average public offering price of $26.68 per share and received net
23
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
12. Shareholders' Equity (Continued)
proceeds of $33.4 million. As of March 31, 2023, an aggregate of $215.6 million of shares of common stock remain available to be issued and sold under the ATM program.
Preferred Stock — As of March 31, 2023, the Company had 200,000,000 shares of preferred stock authorized with a par value of $0.01 per share and no shares of preferred stock were issued and outstanding.
13. Stock-Based Compensation
The Company's current equity compensation plan, the Insmed Incorporated 2019 Incentive Plan (as amended, the 2019 Incentive Plan), was approved by shareholders at the Company's Annual Meeting of Shareholders in May 2019. The 2019 Incentive Plan is administered by the Compensation Committee of the Board of Directors of the Company. Under the terms of the 2019 Incentive Plan, the Company is authorized to grant a variety of incentive awards based on its common stock, including stock options (both incentive stock options and non-qualified stock options), RSUs, performance options/shares and other stock awards to eligible employees and non-employee directors. On May 16, 2019, upon the approval of the 2019 Incentive Plan by shareholders, 3,500,000 shares were authorized for issuance thereunder, plus any shares subject to then-outstanding awards under the Company's 2017 Incentive Plan, the 2015 Incentive Plan and the 2013 Incentive Plan that subsequently were canceled, terminated unearned, expired, were forfeited, lapsed for any reason or were settled in cash without the delivery of shares. On May 12, 2020, at the Company's 2020 Annual Meeting of Shareholders, the Company's shareholders approved an amendment of the 2019 Incentive Plan providing for the issuance of an additional 4,500,000 shares under the plan. On May 12, 2021, at the Company's 2021 Annual Meeting of Shareholders, the Company's shareholders approved the second amendment to the 2019 Incentive Plan providing for the issuance of an additional 2,750,000 shares under the plan. On May 11, 2022, at the Company's 2022 Annual Meeting of Shareholders, the Company's shareholders approved the third amendment to the 2019 Incentive Plan, providing for the issuance of an additional 3,000,000 shares under the plan. The Company has submitted a proposal to its shareholders to approve an Amended and Restated 2019 Incentive Plan at the 2023 Annual Meeting of Shareholders (the Amended and Restated Plan). The Amended and Restated Plan, if approved, will provide for the issuance of an additional 10,500,000 shares under the plan. As of March 31, 2023, 245,789 shares remain available for future issuance under the 2019 Incentive Plan. The 2019 Incentive Plan will terminate on May 16, 2029 unless it is extended or terminated earlier pursuant to its terms. In addition, from time to time, the Company makes inducement grants of stock options to new hires, which awards are made pursuant to the Nasdaq's inducement grant exception to the shareholder approval requirement for grants of equity compensation. During the three months ended March 31, 2023, the Company granted inducement stock options covering 484,390 shares of the Company's common stock to new employees.
On May 15, 2018, the 2018 Employee Stock Purchase Plan (2018 ESPP) was approved by shareholders at the Company's 2018 Annual Meeting of Shareholders. The Company has reserved the following for issuance under the 2018 ESPP: (i) 1,000,000 shares of common stock, plus (ii) commencing on January 1, 2019 and ending on December 31, 2023, an additional number of shares to be added on the first day of each calendar year equal to the lesser of (A) 1,200,000 shares of common stock, (B) 2% of the number of outstanding shares of common stock on such date and (C) an amount determined by the administrator.
Stock Options — As of March 31, 2023, there was $116.5 million of unrecognized compensation expense related to unvested stock options.
As of March 31, 2023, the Company had performance-conditioned options totaling 114,780 shares outstanding which had not yet met the recognition criteria.
Restricted Stock Units — As of March 31, 2023, there was $35.3 million of unrecognized compensation expense related to unvested RSU awards.
Performance Stock Units — As of March 31, 2023, there were 268,442 PSUs outstanding with an unrecognized compensation expense of $10.5 million of unrecognized compensation expense related to unvested PSU awards, which assumes a payout of 100% of the target.
The following table summarizes the aggregate stock-based compensation expense recorded in the consolidated statements of comprehensive loss related to stock options, RSUs and the ESPP during the three months ended March 31, 2023 and 2022, respectively (in millions): 
24
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. Stock-Based Compensation (Continued)
 Three Months Ended March 31,
 20232022
Research and development$7.9 $5.6 
Selling, general and administrative8.5 7.2 
Total$16.4 $12.8 
There was no stock-based compensation expense recorded in the consolidated statements of comprehensive loss related to PSUs during the three months ended March 31, 2023 or March 31, 2022, as the performance conditions associated with the PSU awards were not probable as of either date.
14. Income Taxes
The Company recorded a provision for income taxes of $0.5 million and $0.4 million for the three months ended March 31, 2023 and 2022, respectively. The provisions recorded for the three months ended March 31, 2023 and 2022 are primarily a result of certain of the Company's international subsidiaries, which had taxable income during the periods. Additionally, the Company is impacted by certain state taxes which effectively impose income tax on modified gross revenues. In jurisdictions where the Company has net losses, there was a full valuation allowance recorded against the Company's deferred tax assets and therefore no tax benefit was recorded.
The Company is subject to US federal, state and international income taxes and the statute of limitations for tax audit is open for the Company’s federal tax returns for the years ended 2019 and later, generally open for certain states for the years 2018 and later, and generally open for international jurisdictions for the years 2017 and later. The Company has incurred net operating losses since inception, except for the year ended December 31, 2009. Such loss carryforwards would be subject to audit in any tax year in which those losses are utilized, notwithstanding the year of origin. As of March 31, 2023 and December 31, 2022, the Company had recorded reserves for unrecognized income tax benefits against certain deferred tax assets in the US. However, given the Company’s valuation allowance position, these reserves do not have an impact on the balance sheet as of March 31, 2023 and December 31, 2022 or the consolidated statements of comprehensive loss for the three months ended March 31, 2023 and 2022. The Company has not recorded any accrued interest or penalties related to uncertain tax positions. The Company does not anticipate any material changes in the amount of unrecognized tax positions over the next 12 months.
15. Commitments and Contingencies
Rent expense charged to operations was $2.2 million and $2.0 million for the three months ended March 31, 2023 and 2022, respectively.
Legal Proceedings
From time to time, the Company is a party to various lawsuits, claims and other legal proceedings that arise in the ordinary course of business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters will have a material adverse effect on the Company's consolidated financial position, results of operations or cash flows.
16. Acquisitions
Asset Acquisition
In January 2023, the Company acquired Vertuis, a privately held, preclinical stage company. At the closing of the transaction, the Company issued an aggregate of 500,000 shares of the Company’s common stock to Vertuis’ former stockholders and an individual who are entitled to receive a portion of the acquisition consideration (collectively, the Vertuis equityholders). The closing share price on the date of the transaction was $18.50. The Company is obligated to issue to Vertuis equityholders shares of the Company’s common stock on July 1, 2024 with an aggregate value of $1.0 million, based on the share price on June 28, 2024, and pay to the Vertuis equityholders up to an aggregate of $23.0 million in cash upon the achievement of certain development and regulatory milestone events, and up to an aggregate of $63.8 million in cash upon the achievement of certain net sales-based milestone events, in each case, subject to certain reductions.
The shares of the Company’s common stock issuable to the Vertuis equityholders are being issued pursuant to Section 4(a)(2) of the Securities Act of 1933.
25
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
16. Acquisitions (Continued)
The following table summarizes the purchase price (in millions).
Shares of Insmed common stock issued on closing$9.25 
Shares of Insmed common stock issuable on July 1, 20241.00 
  Total purchase price$10.25 
The Company evaluated the acquisition under ASC 805 and ASU 2017-01 and concluded that substantially all of the fair value of the gross assets acquired are concentrated in a single identifiable asset or a group of similar identifiable assets and accounted for the transaction as an asset acquisition. The Company determined that the assets acquired did not have any future alternative use and, in accordance with ASC 730, Research and Development, expensed the assets within research and development in the consolidated statement of comprehensive loss as of the date of the acquisition.
Business Combination
On August 4, 2021, the Company acquired all of the equity interests of Motus and AlgaeneX, each a privately held, preclinical stage company. In connection with the closing of the Company’s acquisition of Motus, the Company issued an aggregate of 2,889,367 shares of the Company’s common stock, following certain closing-related reductions, to Motus’s former stockholders and option holders and certain individuals who are entitled to receive a portion of the acquisition consideration (collectively, Motus equityholders), subject to certain adjustments. The Company is obligated to issue to Motus equityholders an aggregate of 184,433 shares of the Company’s common stock on each of the first, second and third anniversaries of the closing date and up to 5,348,572 shares in the aggregate upon the achievement of certain development and regulatory milestone events, and to pay to the Motus equityholders an aggregate of $35 million upon the achievement of certain net sales-based milestones and a portion of the value of a priority review voucher (to the extent issued to the Company), in each case, subject to certain reductions. During August 2022, the Company fulfilled the payment due on the first anniversary of the closing date by issuing 171,427 shares of the Company's common stock, after certain reductions.
At the closing of the Company’s acquisition of AlgaeneX, the Company paid $1.5 million in cash to AlgaeneX’s former stockholders and certain individuals who are entitled to receive a portion of the acquisition consideration (collectively, the AlgaeneX equityholders). The Company is obligated to issue to the AlgaeneX equityholders an aggregate of 368,867 shares of the Company’s common stock upon the achievement of a development milestone event and pay to the AlgaeneX equityholders a mid-single digits licensing fee on certain future payments received by the Company in licensing transactions for AlgaeneX’s manufacturing technology, in each case, subject to certain reductions.
The shares of the Company’s common stock issued to the Motus equityholders and the AlgaeneX equityholders were issued, and the shares issuable in the future will be issued, pursuant to Section 4(a)(2) of the Securities Act of 1933, and the numbers of such issued and issuable shares was calculated based on a per share value of $27.11, which was the weighted average price per share of the Company's common stock preceding the closing of the Business Acquisition for the 45 consecutive trading day period beginning on May 24, 2021. The Company will not receive any proceeds from the issuance of common stock to the Motus equityholders or the AlgaeneX equityholders.
The Company evaluated the Business Acquisition under ASC 805 and ASU 2017-01. The Company concluded that substantially all of the fair value of the gross assets acquired is not concentrated in a single identifiable asset or a group of similar identifiable assets. The transaction does not pass the screen test and thus management performed a full assessment to determine if the acquired entities met the definition of a business. For the full assessment, management considered whether it has acquired (a) inputs, (b) substantive processes, and (c) outputs. Under ASC 805, to be considered a business, a set of activities and assets is required to have only the first two of the three elements, which together are or will be used in the future to create outputs. Management determined that the acquired entities met the definition of a business since the Company acquired inputs and substantive processes capable of producing outputs.
Therefore, the transaction has been accounted for under the acquisition method of accounting. Under the acquisition method, the total purchase price of the acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed based on the fair values as of the date of the acquisition. The fair value of the consideration totaled approximately $165.5 million. The results of Motus's and AlgaeneX's operations have been included in the Company's consolidated statements of comprehensive loss beginning on the acquisition date.
The fair value of IPR&D was capitalized as of the acquisition date and accounted for as indefinite-lived intangible assets until completion or disposition of the assets or abandonment of the associated research and development efforts. Upon successful completion of the development efforts, the useful lives of the IPR&D assets will be determined based on the
26
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
16. Acquisitions (Continued)
anticipated period of regulatory exclusivity and will be amortized within operating expenses. Until that time, the IPR&D assets will be subject to impairment testing and will not be amortized. The goodwill recorded related to the acquisition is the excess of the fair value of the consideration transferred by the acquirer over the fair value of the net identifiable assets acquired and liabilities assumed at the date of acquisition. The goodwill recorded is not deductible for tax purposes.
27
Table of Contents
ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements.
                  Forward-looking statements are based on our current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following:
•failure to successfully commercialize ARIKAYCE, our only approved product, in the United States (US), Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain US, European or Japanese approval for ARIKAYCE;
•uncertainties in the degree of market acceptance of ARIKAYCE by physicians, patients, third-party payors and others in the healthcare community;
•our inability to obtain full approval of ARIKAYCE from the US Food and Drug Administration (FDA), including the risk that we will not successfully or in a timely manner complete the study to validate a patient reported outcome (PRO) tool and the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE;
•inability of us, PARI Pharma GmbH (PARI) or our other third-party manufacturers to comply with regulatory requirements related to ARIKAYCE or the Lamira® Nebulizer System (Lamira);
•our inability to obtain adequate reimbursement from government or third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE;
•development of unexpected safety or efficacy concerns related to ARIKAYCE, brensocatib, TPIP or our other product candidates;
•inaccuracies in our estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP or our other product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates;
•the risks and uncertainties associated with, and the perceived benefits of, our secured senior loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements;
•our inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of our product candidates that are approved in the future;
•failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population;
•risk that brensocatib or TPIP does not prove to be effective or safe for patients in ongoing and future clinical studies, including, for brensocatib, the ASPEN study;
•risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication;
•failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products;
•failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP and our other product candidates due to our limited experience in conducting preclinical development activities and clinical trials necessary for regulatory approval and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things;
•risks that our clinical studies will be delayed or that serious side effects will be identified during drug development;
•failure to obtain, or delays in obtaining, regulatory approvals for ARIKAYCE outside the US, Europe or Japan, or for our product candidates in the US, Europe, Japan or other markets, including separate regulatory approval for Lamira in each market and for each usage;
28
Table of Contents
•failure of third parties on which we are dependent to manufacture sufficient quantities of ARIKAYCE or our product candidates for commercial or clinical needs, to conduct our clinical trials, or to comply with our agreements or laws and regulations that impact our business or agreements with us;
•our inability to attract and retain key personnel or to effectively manage our growth;
•our inability to successfully integrate our recent acquisitions and appropriately manage the amount of management’s time and attention devoted to integration activities;
•risks that our acquired technologies, products and product candidates are not commercially successful;
•our inability to adapt to our highly competitive and changing environment;
•risk that we are unable to maintain our significant customers;
•risk that government healthcare reform materially increases our costs and damages our financial condition;
•business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises;
•impact of the COVID-19 pandemic and efforts to reduce its spread on our business, employees, including key personnel, patients, partners and suppliers;
•deterioration in general economic conditions in the US, Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners;
•our inability to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information and costs associated with litigation or other proceedings related to such matters;
•restrictions or other obligations imposed on us by agreements related to ARIKAYCE or our product candidates, including our license agreements with PARI and AstraZeneca AB (AstraZeneca), and failure to comply with our obligations under such agreements;
•the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims;
•risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue;
•our limited experience operating internationally;
•changes in laws and regulations applicable to our business, including any pricing reform, and failure to comply with such laws and regulations;
•our history of operating losses, and the possibility that we never achieve or maintain profitability;
•goodwill impairment charges affecting our results of operations and financial condition;
•inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and
•delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.
We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Any forward-looking statement is based on information current as of the date of this Quarterly Report on Form 10-Q and speaks only as of the date on which such statement is made. Actual events or results may differ materially from the results, plans, intentions or expectations anticipated in these forward-looking statements as a result of a variety of factors, many of which are beyond our control. More information on factors that could cause actual results to differ materially from those anticipated is included from time to time in our reports filed with the Securities and Exchange Commission (SEC), including, but not limited to, those described in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report on Form 10-Q and included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
The following discussion should be read in conjunction with our consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and the consolidated financial statements and related notes thereto in our Annual Report on Form 10-K for the year ended December 31, 2022.
OVERVIEW
      We are a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Our first commercial product, ARIKAYCE, is approved in the US as ARIKAYCE® (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the US in September 2018 for the
29
Table of Contents
treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the EC approved ARIKAYCE for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. In March 2021, Japan's MHLW approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. NTM lung disease caused by MAC (which we refer to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal.
Our clinical-stage pipeline includes brensocatib, TPIP and early-stage research programs. Brensocatib is a small molecule, oral, reversible inhibitor of DPP1, which we are developing for the treatment of patients with bronchiectasis, CF and other neutrophil-mediated diseases, including CRSsNP. TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PH-ILD and PAH. Our early-stage research programs encompass a wide range of technologies and modalities, including gene therapy, artificial intelligence-driven protein engineering, and protein manufacturing.
The information below summarizes the anticipated near-term milestones for ARIKAYCE and our product candidates.
ARIKAYCE
•We will continue to advance the ARISE and ENCORE trials, our post-marketing confirmatory, MAC lung disease clinical trial program for ARIKAYCE.
•We anticipate sharing topline efficacy and safety data from ARISE in the third quarter of 2023.
•We anticipate completing enrollment in ENCORE by the end of 2023.
Brensocatib
•In the first quarter of 2023, we completed enrollment of the Phase 3 ASPEN trial in adult patients, and we anticipate sharing topline data in the second quarter of 2024.
•We plan to explore the potential of brensocatib in additional neutrophil-mediated diseases, including advancing CRSsNP into Phase 2 development in the fourth quarter of 2023.
•We are advancing commercial readiness activities in 2023 in preparation for a launch of brensocatib for patients with bronchiectasis, if approved.
TPIP
•We will continue to advance our Phase 2 studies in both PH-ILD and PAH.
•We anticipate sharing interim, blinded dose titration and safety and tolerability data from both the PH-ILD and PAH studies in the second half of 2023, pending the rate of enrollment.
•We anticipate sharing topline results from the PH-ILD study in the first half of 2024.
Early-Stage Research
•We remain on track to initiate our first clinical trial in gene therapy in the second half of 2023.
•We anticipate sharing preclinical data in musculoskeletal and ocular indications in the first half of 2023.
•We anticipate sharing clinical data from the first trial in a musculoskeletal disease in the first half of 2024.
To complement our internal research and development, we also actively evaluate in-licensing and acquisition opportunities for a broad range of rare diseases.
30
Table of Contents
Our Strategy
Our strategy focuses on the needs of patients with rare diseases. Our first product ARIKAYCE, is approved in the US as ARIKAYCE® (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). We are not aware of any other approved inhaled therapies specifically indicated to treat MAC lung disease in North America, Europe or Japan. We believe that ARIKAYCE has the potential to prove beneficial in other patients with MAC. Our product candidates are brensocatib, our Phase 3 product candidate which we are developing for patients with bronchiectasis, CF and other neutrophil-mediated diseases, and TPIP, our product candidate that may offer a differentiated product profile for patients with PH-ILD and PAH. We are also advancing our early-stage research programs encompassing a wide range of technologies and modalities, including gene therapy, artificial intelligence-driven protein engineering, and protein manufacturing.
Our key priorities are as follows:
•Continue to provide ARIKAYCE to appropriate patients by leveraging and expanding our reliable revenue stream;
•Produce topline clinical data readouts in the near and long term;
•Advance commercial readiness activities to serve significantly more patients with serious and rare diseases; and
•Control spending, prudently deploying capital to support the best return-generating opportunities.
ARIKAYCE for Patients with MAC Lung Disease
ARIKAYCE is our first approved product. ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of refractory MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. In October 2020, ARIKAYCE received approval in Europe for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. In March 2021, ARIKAYCE received approval in Japan for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. MAC lung disease is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. Amikacin solution for parenteral administration is an established drug that has activity against a variety of NTM; however, its use is limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function. Unlike amikacin solution for intravenous administration, our proprietary Pulmovance™ technology uses charge-neutral liposomes to deliver amikacin directly to the lungs where liposomal amikacin is taken up by the lung macrophages where the MAC infection resides. This technology also prolongs the release of amikacin in the lungs, while minimizing systemic exposure, thereby offering the potential for decreased systemic toxicities. ARIKAYCE's ability to deliver high levels of amikacin directly to the lung and sites of MAC infection via the use of our Pulmovance technology distinguishes it from intravenous amikacin. ARIKAYCE is administered once-daily using Lamira, an inhalation device developed and manufactured by PARI. Lamira is a portable nebulizer that enables aerosolization of liquid medications via a vibrating, perforated membrane, and was designed specifically for ARIKAYCE delivery.
The FDA has designated ARIKAYCE as an orphan drug and a Qualified Infectious Disease Product (QIDP) for NTM lung disease. Orphan designated drugs are eligible for seven years of exclusivity for the orphan indication. QIDP designation provides an additional five years of exclusivity for the designated indication. The FDA granted a total of 12 years of exclusivity in the indication for which ARIKAYCE was approved.
ARIKAYCE also has been included in the international treatment guidelines for NTM lung disease. The evidence-based guidelines, issued by the American Thoracic Society (ATS), European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and Infectious Diseases Society of America (IDSA), strongly recommend the use of ARIKAYCE for MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options who have failed to convert to a negative sputum culture after at least six months of treatment.
In October 2020, the FDA approved a supplemental new drug application for ARIKAYCE, adding important efficacy data regarding the durability and sustainability of culture conversion to the ARIKAYCE label. The data, which are from the Phase 3 CONVERT study of ARIKAYCE, demonstrate that the addition of ARIKAYCE to guideline-based therapy (GBT) was associated with sustained culture conversion through the end of treatment as well as durable culture conversion three months post-treatment compared with GBT alone.
Accelerated Approval
In March 2018, we submitted a new drug application (NDA) for ARIKAYCE to the FDA to request accelerated approval. Accelerated approval allows drugs that (i) are being developed to treat a serious or life-threatening disease or condition and (ii) provide a meaningful therapeutic benefit over existing treatments to be approved substantially based on an intermediate endpoint or a surrogate endpoint that is reasonably likely to predict clinical benefit, rather than a clinical endpoint such as survival or irreversible morbidity. In September 2018, the FDA granted accelerated approval for ARIKAYCE under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for the treatment of refractory MAC lung disease
31
Table of Contents
as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options via the accelerated approval pathway. LPAD, which was enacted as part of the 21st Century Cures Act, serves to advance the development of new antibacterial drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs. As required for drugs approved under the LPAD pathway, labeling for ARIKAYCE includes certain statements to convey that the drug has been shown to be safe and effective only for use in a limited population.
As a condition of accelerated approval, we must conduct a post-marketing confirmatory clinical trial. In December 2020, we commenced the post-marketing confirmatory MAC lung disease clinical trial program for ARIKAYCE in patients with MAC lung disease. The MAC lung disease trial program consists of the ARISE trial, an interventional study designed to validate cross-sectional and longitudinal characteristics of a PRO tool in MAC lung disease, and the ENCORE trial, designed to establish the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed or recurrent MAC lung infection who have not started antibiotics using the PRO tool validated in the ARISE trial. We are running these global studies in parallel and approximately 200 sites are expected to be initiated for these clinical trials. We have completed enrollment in the ARISE trial and anticipate completing enrollment in ENCORE by the end of 2023. The MAC lung disease clinical program is intended to fulfill the FDA’s post-marketing requirement to allow for full approval of ARIKAYCE by the FDA, and verification and description of clinical benefit in the ENCORE trial will be necessary for full approval of ARIKAYCE.
Regulatory Pathway Outside of the US
In October 2020, the EC granted marketing authorization for ARIKAYCE for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. ARIKAYCE is now available commercially for patients in several of the major European Union (EU) countries. In October 2022, we secured reimbursement approval for ARIKAYCE in England, at which point ARIKAYCE became reimbursed across all UK nations. In September 2022, patient supply of ARIKAYCE in Germany was enabled by import from other EU countries. We have worked with the German National Association of Statutory Health Insurance Funds (GKV-SV) towards an agreement on the price of ARIKAYCE that would allow us to better serve the needs of patients in Germany; however, to date, we have been unable to reach an agreement. We are working to ensure an uninterrupted supply of ARIKAYCE for patients in Germany and to provide physicians and pharmacists the information they need to obtain ARIKAYCE for their patients through the importation pathway. Discussions remain ongoing with the GKV-SV with the goal of reaching an agreement and re-initiating direct access to ARIKAYCE. In January 2023, we agreed upon reimbursement terms with the French authorities. To date, we have been unable to reach an acceptable agreement of a nationally reimbursed price with the Italian Medicines Agency (AIFA). ARIKAYCE remains commercially available for physicians to prescribe in Italy under Class C, where we set the price and funding is agreed locally. We anticipate recommencing negotiations for national reimbursement in 2023 with the newly constituted AIFA.
In March 2021, Japan's MHLW approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. In July 2021, we launched ARIKAYCE in Japan.
The CONVERT Study and 312 Study
Accelerated approval of ARIKAYCE was supported by preliminary data from the CONVERT study, a global Phase 3 study evaluating the safety and efficacy of ARIKAYCE in adult patients with refractory MAC lung disease, using achievement of sputum culture conversion (defined as three consecutive negative monthly sputum cultures) by Month 6 as the primary endpoint. Patients who achieved sputum culture conversion by Month 6 continued in the CONVERT study for an additional 12 months of treatment following the first monthly negative sputum culture in order to assess the durability of culture conversion, as defined by patients that have completed treatment and continued in the CONVERT study off all therapy for three months. In May 2019, we presented at the American Thoracic Society meeting that 41/65 (63.1%) of patients on ARIKAYCE plus GBT who had achieved culture conversion by Month 6 had maintained durable culture conversion for three months off all therapy compared to 0/10 (0%) on GBT only (p<0.0002). Safety data for these patients were consistent with safety data previously reported for patients by Month 6 of the CONVERT study.
Patients who did not culture convert by Month 6 may have been eligible to enroll in the 312 study, an open-label extension study for these non-converting patients who completed six months of treatment in the CONVERT study. The primary objective of the 312 study was to evaluate the long-term safety and tolerability of ARIKAYCE in combination with a standard multi-drug regimen. The secondary objectives of the 312 study included evaluating the proportion of subjects achieving culture conversion (defined in the same way as the CONVERT study) by Month 6 and the proportion of subjects achieving culture conversion by Month 12, which was the end of treatment. We previously reported interim data as of December 2017 for patients in the 312 study, with 28.4% of patients who received GBT only in the CONVERT study (19/67) and 12.3% of patients who had received ARIKAYCE plus GBT in the CONVERT study (7/57) achieving culture conversion by Month 6 of the 312 study. The 312 study has concluded and final efficacy data regarding culture conversion were consistent with these interim data. We have analyzed the safety and efficacy data from the 312 study, and we did not observe any new safety signals.
32
Table of Contents
Further Research and Lifecycle Management
We are currently exploring and supporting research and lifecycle management programs for ARIKAYCE beyond treatment of refractory MAC lung disease as part of a combination antibacterial regimen for adult patients who have limited or no treatment options. As noted above, we will continue to advance the post-marketing confirmatory, MAC lung disease clinical trial program for ARIKAYCE, through the ARISE and ENCORE trials, which are intended to fulfill the FDA's post-marketing requirement to allow for the full approval of ARIKAYCE in the US, as well as to support the use of ARIKAYCE as a treatment for patients with MAC lung infection.
The ARISE trial is a randomized, double-blind, placebo-controlled Phase 3b study in adult patients with newly diagnosed or recurrent MAC lung infections that aims to generate evidence demonstrating the domain specification, reliability, validity, and responsiveness of PRO-based scores, including a respiratory symptom score. Patients were randomized 1:1 to receive ARIKAYCE plus background regimen or placebo plus background regimen once daily for six months. Patients will then discontinue all study treatments and remain in the trial for one month for the continued assessment of PRO endpoints. In the fourth quarter of 2022, we completed enrollment in the ARISE trial. We anticipate sharing topline efficacy and safety data from ARISE in the third quarter of 2023.
The ENCORE trial is a randomized, double-blind, placebo-controlled Phase 3b study to evaluate the efficacy and safety of an ARIKAYCE-based regimen in patients with newly diagnosed or recurrent MAC lung infection who have not started antibiotics. Patients will be randomized 1:1 to receive ARIKAYCE plus background regimen or placebo plus background regimen once daily for 12 months. Patients will then discontinue all study treatments and remain in the trial for three months for the assessment of durability of culture conversion. The primary endpoint is change from baseline to Month 13 in respiratory symptom score. The key secondary endpoint is the proportion of subjects achieving durable culture conversion at Month 15. The study is currently enrolling patients, and is expected to enroll approximately 250 patients. We anticipate completing enrollment for ENCORE by the end of 2023.
Subsequent lifecycle management studies could also potentially enable us to reach more patients. These initiatives include investigator-initiated studies, which are clinical studies initiated and sponsored by physicians or research institutions with funding from us and may also include new clinical studies sponsored by us.
Product Pipeline
Brensocatib
Brensocatib is a small molecule, oral, reversible inhibitor of DPP1, which we licensed from AstraZeneca in October 2016. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs) in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. Neutrophils contain the NSPs (including neutrophil elastase, proteinase 3, and cathepsin G) that have been implicated in a variety of inflammatory diseases. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs.
Based on the positive results of the WILLOW study discussed below, in December 2020 we commenced our Phase 3 trial, ASPEN, which will investigate brensocatib in bronchiectasis. ASPEN is a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in adult patients with bronchiectasis. Patients with bronchiectasis due to CF may not be enrolled in the study. Patients will be randomized to receive brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks. The primary endpoint is the rate of pulmonary exacerbations over the 52-week treatment period. Secondary endpoints include time to first pulmonary exacerbation, percentage of subjects who remain pulmonary exacerbation-free, change from baseline in post-bronchodilator FEV1, rate of severe pulmonary exacerbations, change from baseline in the Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score, and incidence and severity of treatment-emergent adverse events (AEs). This study completed enrollment of adult patients in the first quarter of 2023. The study enrolled more than 1,700 adult patients at approximately 460 sites in 40 countries. We anticipate sharing topline data in the second quarter of 2024.
In March 2020, AstraZeneca exercised its first option pursuant to our October 2016 license agreement under which AstraZeneca can advance clinical development of brensocatib in the indications of chronic obstructive pulmonary disease (COPD) or asthma. Under the terms of the agreement, upon exercise of this option, AstraZeneca is solely responsible for all aspects of the development of brensocatib up to and including Phase 2b clinical trials in COPD or asthma. The agreement also includes a second and final option which, if exercised, would permit AstraZeneca to further develop brensocatib beyond Phase 2b clinical trials upon reaching agreement on commercial terms satisfactory to each party for the further development and commercialization of brensocatib in COPD or asthma. We retain full development and commercialization rights for brensocatib in all other indications and geographies.
In June 2020, the FDA granted breakthrough therapy designation for brensocatib for the treatment of adult patients
33
Table of Contents
with non-cystic fibrosis bronchiectasis (NCFBE) for reducing exacerbations. The FDA's breakthrough therapy designation is designed to expedite the development and review of therapies that are intended to treat serious or life-threatening diseases and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy. The benefits of breakthrough therapy designation include more frequent communication and meetings with FDA, eligibility for rolling and priority review, intensive guidance on an efficient drug development program, and organizational commitment from the FDA involving senior managers. In November 2020, brensocatib was granted access to the PRIME scheme from the European Medicines Agency (EMA) for patients with NCFBE.
In October 2021, the EMA’s Paediatric Committee approved the brensocatib Pediatric Investigational Plan for the treatment of patients with NCFBE. Subsequently, the ASPEN trial will now include 40 adolescent patients between ages 12 to 17, which will fulfill the pediatric study requirements to support marketing applications in this patient population in the US, Europe and Japan.
The WILLOW Study
The WILLOW study was a randomized, double-blind, placebo-controlled, parallel-group, multi-center, multi-national, Phase 2 study to assess the efficacy, safety and tolerability, and pharmacokinetics of brensocatib administered once daily for 24 weeks in patients with NCFBE. The WILLOW study was conducted at 116 sites and enrolled 256 adult patients diagnosed with NCFBE who had at least two documented pulmonary exacerbations in the 12 months prior to screening. Patients were randomized 1:1:1 to receive either 10 mg or 25 mg of brensocatib or matching placebo. The primary efficacy endpoint was the time to first pulmonary exacerbation over the 24-week treatment period in the brensocatib arms compared to the placebo arm.
WILLOW Efficacy Data
We announced topline data for the WILLOW study in February 2020 and full data for the WILLOW study in June 2020. In September 2020, final results from the WILLOW study were published online in the New England Journal of Medicine. The data demonstrate that the WILLOW study met its primary endpoint of time to first pulmonary exacerbation over the 24-week treatment period for both the 10 mg and 25 mg dosage groups of brensocatib compared to placebo (p=0.027, p=0.044, respectively). The risk of exacerbation at any time during the trial was reduced by 42% for the 10 mg group versus placebo (HR 0.58, p=0.029) and by 38% for the 25 mg group versus placebo (HR 0.62, p=0.046). In addition, treatment with brensocatib 10 mg resulted in a significant reduction in the rate of pulmonary exacerbations, a key secondary endpoint, versus placebo. Specifically, patients treated with brensocatib experienced a 36% reduction in the 10 mg arm (p=0.041) and a 25% reduction in the 25 mg arm (p=0.167) versus placebo. Change in concentration of active NE in sputum versus placebo from baseline to the end of the treatment period was also statistically significant (p=0.034 for 10 mg, p=0.021 for 25 mg).
WILLOW Safety and Tolerability Data
Brensocatib was generally well-tolerated in the study. Rates of AEs leading to discontinuation in patients treated with placebo, brensocatib 10 mg, and brensocatib 25 mg were 10.6%, 7.4%, and 6.7%, respectively. The most common AEs in patients treated with brensocatib were cough, headache, sputum increase, dyspnea, fatigue, and upper respiratory tract infection. Rates of adverse events of special interest (AESIs) in patients treated with placebo, brensocatib 10 mg, and brensocatib 25 mg, respectively, were as follows: rates of skin events (including hyperkeratosis) were 11.8%, 14.8%, and 23.6%; rates of dental events were 3.5%, 16.0%, and 10.1%; and rates of infections that were considered AESIs were 17.6%, 13.6%, and 16.9%.
Further Research and Development
In August 2019, we received notice from the FDA that we were awarded a development grant of $1.8 million for specific work to be performed on a PRO tool. The grant funding is for the development of a novel PRO tool for use in clinical trials to measure symptoms in patients with NCFBE with and without NTM lung infection.
In January 2023, we reported topline data from the Phase 2, multiple-dose, pharmacokinetic/pharmacodynamic study of brensocatib in patients with CF. This Phase 2 study included both patients who were on background CFTR modulator drugs and patients who were not on CFTR modulator drugs. The study duration was approximately one month and dosed CF patients to placebo, 10 mg, 25 mg, and 40 mg of brensocatib. A clear dose-dependent and exposure-dependent inhibition of blood NSPs was observed in patients treated with brensocatib across all doses in this study, consistent with the mechanism of action of brensocatib. Safety and tolerability were consistent with what was observed during the Phase 2 WILLOW study, with no significant drug-related findings. We concluded that an additional cohort evaluating a 65 mg dose of brensocatib is not needed in this patient population. We believe that we can use the data from this Phase 2 study, in addition to the clinical work done for the WILLOW and ASPEN studies, to help inform the safety and efficacy of brensocatib for CF patients.
We also plan to explore the potential of brensocatib in additional neutrophil-mediated diseases, including CRSsNP. CRSsNP currently has no approved therapies and many patients do not respond to corticosteroids or endoscopic sinus surgery. We anticipate moving brensocatib into Phase 2 development for CRSsNP in the fourth quarter of 2023.
Market Opportunity for Brensocatib in Bronchiectasis
34
Table of Contents
Bronchiectasis is a severe, chronic pulmonary disorder in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. Based on information from external sources, including market research funded by us and third parties, and internal analyses and calculations, we estimate the potential addressable market at launch in the US, the European 5 and Japan will be as follows (approximately):
Potential MarketEstimated Number of Patients Diagnosed with Bronchiectasis
United States450,000
European 5400,000
Japan150,000
Today, there are no approved therapies in the US, Europe, or Japan for the treatment of patients with bronchiectasis.
Treprostinil Palmitil Inhalation Powder
TPIP is an investigational inhaled formulation of a treprostinil prodrug that has the potential to address certain of the current limitations of existing prostanoid therapies. We believe that TPIP prolongs duration of effect and may provide patients with greater consistency in pulmonary arterial pressure reduction over time. Current inhaled prostanoid therapies must be dosed four to nine times per day. Reducing dose frequency has the potential to ease patient burden and improve compliance. Additionally, we believe that TPIP may be associated with fewer side effects, including severity and/or frequency of cough, headache, throat irritation, nausea, flushing and dizziness that are associated with high initial drug levels and local upper airway exposure when using current inhaled prostanoid therapies. We believe TPIP may offer a differentiated product profile for PH-ILD and PAH.
In February 2021, we announced topline results from the Phase 1 study of TPIP in healthy volunteers. The objective of this first-in-human single ascending dose and multiple ascending dose study was to assess the pharmacokinetics and tolerability profile of TPIP. Data from the study demonstrated that TPIP was generally well tolerated, with a pharmacokinetic profile that supports continued development with once-daily dosing. The most common AEs across all cohorts in the study were cough, dizziness, headache, and nausea. Most AEs were mild in severity and consistent in nature with those typically seen with other inhaled prostanoid therapies. There were few moderate AEs and no severe or serious AEs. Subjects in the multiple dose panel that incorporated an up-titration approach beginning at 112.5 µg once-daily and progressing to 225 µg once-daily reported fewer AEs compared to the panel dosed with 225 µg once-daily from the first dose.
Overall pharmacokinetic results demonstrated that treprostinil exposure (AUC and Cmax) was dose-proportional, with low to moderate inter-subject variability. Treprostinil was detected in the plasma at 24 hours at all doses and throughout the 48-hour sampling period for the two highest doses. Compared with currently available inhaled treprostinil therapy, TPIP showed substantially lower Cmax and longer half-life. Data from this study were presented in an oral session at the European Society of Cardiology Congress in August 2021.
We are advancing the development of TPIP with two ongoing Phase 2 studies. The first study is designed to assess the safety and tolerability of TPIP in patients with PH-ILD over a 16-week treatment period using an up-titration, once-daily dosing schedule. The second study is designed to investigate the effect of TPIP in patients with PAH on changes in PVR and six-minute walk distance over a 16-week treatment period and will also employ an up-titration, once-daily dosing schedule. A third study, which was a Phase 2a study designed to study the immediate impact of a single dose of TPIP in PAH patients over a 24-hour period was discontinued primarily due to hospital and intensive care unit restrictions during the COVID-19 pandemic that were necessary to conduct the study. One patient was dosed in this study at 112.5 micrograms. This patient went on to complete the 16-week extension period for the study and was titrated to a dose of 320 micrograms once daily, which was found to be safe and tolerable. We did not observe any safety concerns with TPIP, and the data suggested a trend toward improvement in various cardiac measures during the study period.
We will continue to advance our Phase 2 development work in both PH-ILD and PAH. We anticipate sharing interim, blinded dose titration and safety and tolerability data from the PH-ILD study in the second half of 2023. We expect topline results from the PH-ILD study to be shared in the first half of 2024.
Early-Stage Research
Our early-stage research efforts are comprised of our preclinical programs, advanced through internal research and development and augmented through business development activities. In March 2021, we acquired a proprietary protein deimmunization platform, called Deimmunized by Design, focused on the reengineering of therapeutic proteins to evade immune recognition and reaction. In August 2021, we acquired Motus and AlgaeneX, preclinical stage companies engaged in the research, development and manufacturing of gene therapies for rare genetic disorders. In January 2023, we acquired
35
Table of Contents
Vertuis, a privately held, preclinical stage company engaged in the research and development of gene therapies for rare genetic disorders. We believe that animal studies may demonstrate the viability of these potential medicines to address serious unmet medical needs in various therapeutic areas.
Our initial therapeutic areas of focus include musculoskeletal, CNS, ocular, and rheumatologic diseases. We remain on track to initiate our first clinical trial in gene therapy in the second half of 2023. Preclinical data in musculoskeletal and ocular indications are also expected in the first half of 2023 and clinical data from the first trial in a musculoskeletal disease are anticipated in the first half of 2024.
Corporate Development
We plan to continue to develop, acquire, in-license or co-promote other products, product candidates and technologies, including those that address serious and rare diseases that currently have significant unmet needs. We are focused broadly on serious and rare disease therapeutics and prioritizing those areas that best align with our core competencies.
KEY COMPONENTS OF OUR RESULTS OF OPERATIONS
Product Revenues, Net
Product revenues, net, consist of net sales of ARIKAYCE. In October 2018, we began shipping ARIKAYCE to our customers in the US, which include specialty pharmacies and specialty distributors. In December 2020, we began commercial sales of ARIKAYCE in Europe. In July 2021, we began recognizing product revenue from commercial sales of ARIKAYCE in Japan. We recognize revenue for product received by our customers net of allowances for customer credits, including prompt pay discounts, service fees, estimated rebates, including government rebates, such as Medicaid rebates and Medicare Part D coverage gap reimbursements in the US, and chargebacks.
Cost of Product Revenues (Excluding Amortization of Intangible Assets)
Cost of product revenues (excluding amortization of intangible assets) consist primarily of direct and indirect costs related to the manufacturing of ARIKAYCE sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs, in addition to royalty expenses and revenue-based milestones. We began capitalizing inventory upon FDA approval of ARIKAYCE. All costs related to inventory for ARIKAYCE prior to FDA approval were expensed as incurred and therefore not included in cost of product revenues.
Research and Development (R&D) Expenses
R&D expenses consist of salaries, benefits and other related costs, including stock-based compensation, for personnel serving in our research and development functions, including medical affairs and program management. R&D expenses also includes other internal operating expenses, the cost of manufacturing product candidates, including the medical devices for drug delivery, for clinical study, the cost of conducting clinical studies, and the cost of conducting preclinical and research activities. In addition, R&D expenses include payments to third parties for the license rights to products in development (prior to marketing approval), such as brensocatib. Our R&D expenses related to manufacturing our product candidates and medical devices for clinical study are primarily related to activities at CMOs that manufacture brensocatib, TPIP and early-stage research activities. Our R&D expenses related to clinical trials are primarily related to activities at contract research organizations (CROs) that conduct and manage clinical trials on our behalf. These contracts with CROs set forth the scope of work to be completed at a fixed fee or amount per patient enrolled. Payments under these contracts with CROs primarily depend on performance criteria such as the successful enrollment of patients or the completion of clinical trial milestones as well as time-based fees. Expenses are accrued based on contracted amounts applied to the level of patient enrollment and to activity according to the clinical trial protocol. Deposits for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are then recognized as an expense as the related goods are delivered or the services are performed.
Selling, General and Administrative (SG&A) Expenses
SG&A expenses consist of salaries, benefits and other related costs, including stock-based compensation, for our non-employee directors and personnel serving in our executive, finance and accounting, legal and compliance, commercial and pre-commercial, corporate development, field sales, information technology and human resource functions. SG&A expenses also include professional fees for legal services, consulting services, including commercial activities, insurance, board of director fees, tax and accounting services and certain milestones related to ARIKAYCE.
Amortization of Intangible Assets
Upon commercialization of ARIKAYCE, our intangible assets began to be amortized over their estimated useful lives. The fair values assigned to our intangible assets are based on estimates and assumptions we believe are reasonable based on available facts and circumstances. Unanticipated events or circumstances may occur that require us to review the assets for impairment.
36
Table of Contents
Change in Fair Value of Deferred and Contingent Consideration Liabilities
In connection with our Business Acquisition, we recorded deferred and contingent consideration liabilities related to potential future milestone payments. Adjustments to the fair value are due to changes in: the probability of achieving milestones; our stock price; or certain other estimated assumptions. The change in fair value of deferred and contingent consideration liabilities is calculated quarterly with gains and losses recorded in the consolidated statements of comprehensive loss.
Investment Income and Interest Expense
Investment income consists of interest and dividend income earned on our cash and cash equivalents and marketable securities. Interest expense consists primarily of contractual interest costs, Royalty Financing Agreement non-cash interest expense and the amortization of debt issuance costs related to our debt. Debt issuance costs are amortized to interest expense using the effective interest rate method over the term of the debt. Our balance sheet reflects debt, net of the debt discount, debt issuance costs paid to the lender, and other third-party costs. Unamortized debt issuance costs associated with extinguished debt are expensed in the period of the extinguishment.
Change in Fair Value of Interest Rate Swap
We record derivative and hedge transactions in accordance with GAAP. In the fourth quarter of 2022, we entered into an interest rate swap contract (the Swap Contract) with a notional value of $350 million to economically hedge our variable rate-based term debt for three years, effectively changing the variable rate under the term debt to a fixed interest rate. Our interest rate swap has not been designated as a hedging instrument for accounting purposes. Consequently, all changes in the fair value of the Swap Contract are reported as a component of net loss in the consolidated statements of comprehensive loss.
RESULTS OF OPERATIONS
Comparison of the Three Months Ended March 31, 2023 and 2022
Overview - Operating Results
Our operating results for the three months ended March 31, 2023, included the following:
•Product revenues, net, increased $12.1 million, or 22.8%, as compared to the same period in the prior year as a result of the growth in ARIKAYCE sales;
•Cost of product revenues (excluding amortization of intangible assets) increased $1.6 million as compared to the same period in the prior year as a result of the increase in sales volumes of ARIKAYCE;
•R&D expenses increased $43.5 million as compared to the same period in the prior year primarily resulting from increases in clinical development and research for our ongoing clinical trials;
•SG&A expenses increased $23.2 million as compared to the same period in the prior year resulting primarily from increases in professional fees and other external expenses;
•Amortization of intangible assets of $1.3 million was consistent with the same period in the prior year;
•Change in fair value of deferred and contingent consideration liabilities decreased $2.1 million, primarily as a result of the change in our share price; and
•Interest expense increased $16.7 million as compared to the same period in the prior year due to entering into the Term Loan and Royalty Financing Agreement in the fourth quarter of 2022.
Product Revenues, Net
Product revenues, net, consists of net sales of ARIKAYCE. The following table summarizes revenue by geography for the three months ended March 31, 2023 and 2022 (in thousands):
Three Months Ended March 31,Increase (decrease)
20232022$%
US$49,067 $40,782 $8,285 20.3%
Japan13,156 10,676 2,480 23.2%
Europe and rest of world2,991 1,649 1,342 81.4%
  Total product revenues, net$65,214 $53,107 $12,107 22.8%
Product revenues, net, for the three months ended March 31, 2023 increased to $65.2 million as compared to $53.1 million in the same period in 2022, an increase of 22.8% as a result of growth in ARIKAYCE sales in the US, Japan and Europe and the rest of the world.
37
Table of Contents
Cost of Product Revenues (excluding amortization of intangible assets)
Cost of product revenues (excluding amortization of intangible assets) for the three months ended March 31, 2023 and 2022 were comprised of the following (in thousands):
Three Months Ended March 31,Increase (decrease)
20232022$%
Cost of product revenues (excluding amortization of intangible assets)$13,830 $12,191 $1,639 13.4 %
Cost of product revenues, as % of revenues21.2 %23.0 %
Cost of product revenues (excluding amortization of intangible assets) increased by $1.6 million, or 13.4%, to $13.8 million for the three months ended March 31, 2023 as compared to $12.2 million in the same period in 2022. The increase in cost of product revenues (excluding amortization of intangibles) in the three months ended March 31, 2023 was primarily attributable to the increase in product revenues discussed above.
R&D Expenses
R&D expenses for the three months ended March 31, 2023 and 2022 were comprised of the following (in thousands):
 Three Months Ended March 31,Increase (decrease)
 20232022$%
External Expenses    
Clinical development and research$43,138 $33,101 $10,037 30.3 %
Vertuis non-cash asset acquisition10,250 — 10,250 NA
Manufacturing13,612 10,373 3,239 31.2 %
Regulatory, quality assurance, and medical affairs10,330 4,996 5,334 106.8 %
Subtotal—external expenses$77,330 $48,470 $28,860 59.5 %
Internal Expenses    
Compensation and benefit related expenses$33,236 $24,495 $8,741 35.7 %
Stock-based compensation7,899 5,615 2,284 40.7 %
Other internal operating expenses9,400 5,776 3,624 62.7 %
Subtotal—internal expenses$50,535 $35,886 $14,649 40.8 %
   Total R&D expenses$127,865 $84,356 $43,509 51.6 %
R&D expenses increased to $127.9 million during the three months ended March 31, 2023 from $84.4 million in the same period in 2022. The $43.5 million increase was primarily due to the $10.3 million non-cash cost of the Vertuis acquisition, a $10.0 million increase in clinical development and research expenses to support the ongoing Phase 3 ASPEN trial of brensocatib and the ARIKAYCE MAC lung disease clinical trial program and an $11.0 million increase in compensation and benefit related expenses and stock-based compensation costs due to an increase in headcount.
External R&D expenses by product for the three months ended March 31, 2023 and 2022 were comprised of the following (in thousands):
Three Months Ended March 31,Increase (decrease)
20232022$%
ARIKAYCE external R&D expenses$18,249 $16,678 $1,571 9.4 %
Brensocatib external R&D expenses26,535 21,726 4,809 22.1 %
Vertuis non-cash asset acquisition10,250 — 10,250 NA
Other external R&D expenses22,296 10,066 12,230 121.5 %
   Total external R&D expenses$77,330 $48,470 $28,860 59.5 %
We expect R&D expenses to continue to increase in 2023 relative to 2022 primarily due to our clinical trial activities and related spend, including our Phase 3 ASPEN trial of brensocatib, our confirmatory clinical trial of ARIKAYCE in a treatment setting for patients with MAC lung disease, our TPIP clinical trials and our research efforts in early stage research.
38
Table of Contents
SG&A Expenses
SG&A expenses for the three months ended March 31, 2023 and 2022 were comprised of the following (in thousands):
 
 Three Months Ended March 31,Increase (decrease)
20232022$%
Compensation and benefit related expenses$28,395 $22,953 $5,442 23.7 %
Stock-based compensation8,545 7,206 1,339 18.6 %
Professional fees and other external expenses29,966 19,741 10,225 51.8 %
Facility related and other internal expenses13,008 6,848 6,160 90.0 %
Total SG&A expenses$79,914 $56,748 $23,166 40.8 %
SG&A expenses increased to $79.9 million during the three months ended March 31, 2023 from $56.7 million in the same period in 2022. The $23.2 million increase resulted primarily from a $10.2 million increase in professional fees and other external expenses driven by commercial readiness activities for brensocatib. The increase was also due to a $6.8 million increase in compensation and benefit related expenses and stock-based compensation costs due to an increase in headcount. We expect SG&A expenses to continue to increase in 2023 relative to 2022 due, in part, to commercial readiness activities for brensocatib.
Amortization of Intangible Assets
Amortization of intangible assets for both the three months ended March 31, 2023 and 2022 was $1.3 million. Amortization of intangible assets is comprised of amortization of acquired ARIKAYCE R&D and amortization of the milestones paid to PARI for the FDA and EC approvals of ARIKAYCE.
Change in Fair Value of Deferred and Contingent Consideration Liabilities
The change in fair value of deferred and contingent consideration for the three months ended March 31, 2023 was $(9.5) million as a result of our Business Acquisition in the third quarter of 2021. Adjustments to the fair value are due to changes in factors such as the probability of achieving milestones, our stock price, or certain other estimated assumptions.
Interest Expense
Interest expense increased to $20.0 million for the three months ended March 31, 2023 as compared to $3.3 million in the same period in 2022 due to entering into the Term Loan and Royalty Financing Agreement in the fourth quarter of 2022. See Note 10 - Debt and Note 11 - Royalty Financing Agreement for further details.
Change in Fair Value of Interest Rate Swap
The change in fair value of interest rate swap for the three months ended March 31, 2023 was $1.5 million. Adjustments to the fair value are due to changes in interest rates as of March 31, 2023 relative to the fair value of interest rate swap as of December 31, 2022.
LIQUIDITY AND CAPITAL RESOURCES
 Overview
     There is considerable time and cost associated with developing potential pharmaceutical products to the point of regulatory approval and commercialization. We commenced commercial shipments of ARIKAYCE in October 2018. We expect to continue to incur consolidated operating losses, including losses at our US and certain international entities, as we plan to fund R&D for ARIKAYCE, brensocatib, TPIP and our other pipeline programs, continue commercialization and regulatory activities for ARIKAYCE, fund pre-commercialization activities for brensocatib, and engage in other general and administrative activities.
In October 2022, we entered into the $350 million Term Loan with Pharmakon that matures on October 19, 2027. The Term Loan bears interest at a rate based upon the SOFR, subject to a SOFR floor of 2.5%, in addition to a margin of 7.75% per annum. Up to 50% of the interest payable during the first 24 months from the closing of the Term Loan may be paid-in-kind at our election. If elected, paid-in-kind interest will be capitalized and added to the principal amount of the Term Loan. The Term Loan, including the paid-in-kind interest, will be repaid in eight equal quarterly payments starting in the 13th quarter following the closing of the Term Loan (i.e., the quarter ending March 31, 2026), except that the repayment start date may be extended at our option for an additional four quarters, so that repayments start in the 17th quarter following the closing of the Term Loan, subject to the achievement of specified ARIKAYCE data thresholds and certain other conditions. Net proceeds from the Term Loan, after deducting the lenders' fees and deal expenses of $15.2 million, were $334.8 million.
39
Table of Contents
In October 2022, we entered into the Royalty Financing Agreement with OrbiMed, whereby OrbiMed paid us $150 million in exchange for the right to receive, on a quarterly basis, royalties in an amount equal to 4% of ARIKAYCE global net sales prior to September 1, 2025 and 4.5% of ARIKAYCE global net sales on or after September 1, 2025, as well as 0.75% of brensocatib global net sales, if approved. In the event that OrbiMed has not received aggregate Revenue Interest Payments equal to or greater than $150 million on or prior to March 31, 2028, the royalty rate for ARIKAYCE will be increased for all subsequent fiscal quarters to a rate which, if applied retroactively, would have resulted in aggregate Revenue Interest Payments to OrbiMed for all fiscal quarters ended on or prior to March 31, 2028 equal to $150 million. In addition, we must make a one-time payment to OrbiMed in an amount that, when added to the aggregate amount of Revenue Interest Payments received by OrbiMed as of March 31, 2028, would equal $150 million. The total Revenue Interest Payments payable by us to OrbiMed are capped at 1.8x of the purchase price or up to a maximum of 1.9x of the purchase price under certain conditions. Net proceeds from the Royalty Financing Agreement, after deducting the lenders fees and deal expenses of $3.8 million, were $146.2 million.
In October 2022, we also completed an underwritten offering of 13,750,000 shares of our common stock at a public offering price of $20.00 per share. Our net proceeds from the sale of the shares, after deducting the underwriting discounts and offering expense of $16.2 million, were $258.8 million.
We may need to raise additional capital to fund our operations, the continued commercialization of ARIKAYCE, launch readiness activities for the potential launch of brensocatib for the treatment of patients with bronchiectasis, if approved, clinical trials for brensocatib, TPIP, and our future product candidates, and to develop, acquire, in-license or co-promote other products or product candidates, including those that address serious or rare diseases. While we believe we currently have sufficient funds to meet our financial needs for at least the next 12 months, we may opportunistically raise additional capital and may do so through equity or debt financing(s), strategic transactions or otherwise. Our cash requirements for the next 12 months will be impacted by a number of factors, the most significant of which we expect to be the ASPEN trial, expenses related to our commercialization efforts and our ARISE and ENCORE clinical trials for ARIKAYCE, and other development activities for brensocatib, and to a lesser extent, expenses related to the clinical development of TPIP and our early-research programs.
Cash Flows
As of March 31, 2023, we had cash and cash equivalents of $968.9 million, as compared with $1,074.0 million as of December 31, 2022. In addition, as of March 31, 2023, we had marketable securities of $29.8 million as compared with $74.2 million as of December 31, 2022. The $105.1 million decrease in cash and cash equivalents was primarily due to the purchase of marketable securities and cash used in operating activities. Our working capital was $941.1 million as of March 31, 2023, as compared with $1,083.1 million as of December 31, 2022.
Net cash used in operating activities was $146.3 million and $105.2 million for the three months ended March 31, 2023 and 2022, respectively. The net cash used in operating activities during the three months ended March 31, 2023 and 2022 was primarily for the commercial, clinical and manufacturing activities related to ARIKAYCE, as well as other SG&A expenses and clinical trial expenses related to brensocatib and TPIP. The increase in cash used in operating activities for the three months ended March 31, 2023 compared to the corresponding period in 2022 was primarily due to the increase in net loss, excluding the adjustments to reconcile net loss to net cash used in operating activities.
Net cash provided by (used in) investing activities was $41.6 million and $(101.4) million for the three months ended March 31, 2023 and 2022, respectively. The decrease in 2023 is due to purchases of marketable securities in three months ended March 31, 2022 and the maturity of marketable securities in the three months ended March 31, 2023.
Net cash (used in) provided by financing activities was $(0.4) million and $6.5 million for the three months ended March 31, 2023 and 2022, respectively. The decrease in 2023 is due to decrease in net cash proceeds from the exercise of stock options in the three months ended March 31, 2023.
Contractual Obligations
There were no material changes outside of the ordinary course of business in our contractual obligations during the three months ended March 31, 2023 from those disclosed in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Contractual Obligations” in our Annual Report on Form 10-K for the year ended December 31, 2022.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. We do not have any interest in special purpose entities, structured finance entities or other variable interest entities.
CRITICAL ACCOUNTING ESTIMATES
40
Table of Contents
There have been no material changes to our critical accounting policies and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022. For the required interim disclosure updates related to our accounting policies and estimates, see Note 2 — Summary of Significant Accounting Policies in this Quarterly Report on Form 10-Q.
ITEM 3.                                                QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of March 31, 2023, our cash and cash equivalents were in cash accounts and money market funds. Our investments in money market funds are not insured by the federal government. As of March 31, 2023, our marketable securities were invested in US treasury notes with an original maturity of greater than 90 days.
As of March 31, 2023, we had $800.0 million of convertible notes outstanding. Our 2025 Convertible Notes and our 2028 Convertible Notes bear interest at a coupon rate of 1.75% and 0.75%, respectively. In addition, as of March 31, 2023, we had a $350 million Term Loan and a $150.0 million Royalty Financing Agreement outstanding. The Term Loan accrues interest quarterly at the SOFR subject to a floor of 2.5%, plus a margin of 7.75% per annum. We entered into the Swap Contract as a hedge to the Term Loan variable interest rate. The Royalty Financing Agreement pays interest at 4% of ARIKAYCE global net sales prior to September 1, 2025 and 4.5% thereafter as well as 0.75% of brensocatib global net sales, if approved. If a 10% change in interest rates had occurred on March 31, 2023, it would not have had a material effect on the fair value of our debt as of that date, nor would it have a material effect on our future earnings or cash flows.
The majority of our business is conducted in US dollars. However, we do conduct certain transactions in other currencies, including Euros, British Pounds, and Japanese Yen. Historically, fluctuations in foreign currency exchange rates have not materially affected our results of operations and during the three months ended March 31, 2023 and 2022, our results of operations were not materially affected by fluctuations in foreign currency exchange rates.
ITEM 4.                                                CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as amended (the Exchange Act), means controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit with the SEC is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. Based on that evaluation as of March 31, 2023, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended March 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1.                                                LEGAL PROCEEDINGS
From time to time, we are party to various lawsuits, claims and other legal proceedings that arise in the ordinary course of our business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters will have a material adverse effect on our consolidated financial position, results of operations or cash flows.
ITEM 1A.                                       RISK FACTORS
Our business is subject to substantial risks and uncertainties. You should carefully consider the risk factors set forth below as well as the other information contained in this Quarterly Report on Form 10-Q and in our other public filings in evaluating our business, including our Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC on February 23, 2023. Any of the risks and uncertainties described below and in our other filings with the SEC, either alone or taken together, could materially and adversely affect our business, financial condition, results of operations, prospects for growth, and the value of an investment in our common stock. In addition, these risks and uncertainties could cause actual results to differ materially from those expressed or implied by forward-looking statements contained in this Form 10-Q (please read the Cautionary Note Regarding Forward-Looking Statements in this Form 10-Q).
ITEM 2.     UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
41
Table of Contents
On January 6, 2023, the Company acquired Vertuis, a privately held, preclinical stage company. In connection with the transaction, the Company issued an aggregate of 500,000 shares of the Company’s common stock to the Vertuis equityholders. The Company is obligated to issue to Vertuis equityholders shares of the Company’s common stock on July 1, 2024 having an aggregate value of $1 million, based on the share price on June 28, 2024. The shares of the Company’s common stock issuable to the Vertuis equityholders are being issued pursuant to Section 4(a)(2) of the Securities Act of 1933. The Company did not and will not receive any proceeds from the issuance of common stock to the Vertuis equity holders.
ITEM 5.    OTHER INFORMATION
None.
    
ITEM 6.    EXHIBITS
Exhibit Index
Articles of Incorporation of Insmed Incorporated, as amended through June 14, 2012 (incorporated by reference from Exhibit 3.1 to Insmed Incorporated’s Annual Report on Form 10-K filed on March 18, 2013).
Amended and Restated Bylaws of Insmed Incorporated (incorporated by reference from Exhibit 3.1 to Insmed Incorporated’s Current Report on Form 8-K filed on March 30, 2020).
Form of Insmed Incorporated Non-Qualified Stock Option Inducement Award Agreement.
Form of Insmed Incorporated Non-Qualified Stock Option Inducement Award Agreement for non-U.S. employees.
Certification of William H. Lewis, Chair and Chief Executive Officer (Principal Executive Officer) of Insmed Incorporated, pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
Certification of Sara Bonstein, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) of Insmed Incorporated, pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
Certification of William H. Lewis, Chair and Chief Executive Officer (Principal Executive Officer) of Insmed Incorporated, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
Certification of Sara Bonstein, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) of Insmed Incorporated, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
101The following materials from Insmed Incorporated’s quarterly report on Form 10-Q for the quarter ended March 31, 2023 formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022, (ii) Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2023 and 2022, (iii) Consolidated Statements of Shareholders' Equity for the three months ended March 31, 2023 and 2022, (iv) Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022, (v) Notes to the Unaudited Consolidated Financial Statements, and (vi) Cover Page.
104The cover page from the Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, formatted in iXBRL and contained in Exhibit 101.
* Management contract or compensatory plan or arrangement.

42
Table of Contents
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
  INSMED INCORPORATED
 
 
Date: May 4, 2023By/s/ Sara Bonstein
  Sara Bonstein
  Chief Financial Officer
  (Principal Financial and Accounting Officer)

43

INSMED INCORPORATED
NONQUALIFIED STOCK OPTION INDUCEMENT AWARD AGREEMENT
No. of shares subject to Option: /$AwardsGranted$/

THIS AGREEMENT dated this /$GrantDate$/ (this “Agreement”), between INSMED INCORPORATED, a Virginia corporation (the “Company”), and /$ParticipantName$/ (the “Participant”), is an inducement material to Participant’s entry into employment with the Company or a subsidiary of the Company within the meaning of Rule 5635(c)(4) of the NASDAQ Listing Rules (the “Inducement Award Rule”). If and to the extent that this Agreement conflicts or is inconsistent with the terms, conditions and provisions of Participant’s offer letter or employment agreement with the Company or the applicable subsidiary thereof, dated as of /$HireDate$/ (the “Employment Agreement”), the Employment Agreement shall control, and this Agreement shall be deemed to be modified accordingly so long as such modification is consistent with the Inducement Award Rule and applicable law.

1.Grant of Option. The Company, on /$GrantDate$/ (the “Date of Grant”), granted to Participant, subject to the terms and conditions herein set forth, the right and option to purchase from the Company all or any part of an aggregate of /$AwardsGranted$/ shares of common stock of the Company, par value US $0.01 per share (the “Common Stock”) at the option price of /$GrantPrice$/ per share, being not less than the closing price of a share of the Company’s Common Stock on the NASDAQ on the Date of Grant (the “Option”). The Option is intended to be a nonqualified stock option and not an “incentive stock option” within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”). The Option is exercisable as hereinafter provided.
2.Terms and Conditions. The Option is subject to the following terms and conditions:
a.Expiration Date. The Option shall expire ten years from the Date of Grant (the “Expiration Date”).
b.Exercise of Option. Except as provided in paragraphs 3, 4 and 5, the Option shall be exercisable with respect to twenty-five percent (25%) of the shares of Common Stock subject to the Option on the first annual anniversary of the Date of Grant (the “First Anniversary Date”) and with respect to twelve and a half percent (12.5%) of the shares of Common Stock subject to the Option on the six-month anniversary of the First Anniversary Date and each six-month anniversary date thereafter through the fourth annual anniversary of the Date of Grant, subject to Participant’s continued employment through each applicable date. If the foregoing schedule would produce fractional shares, the number of shares for which the Option becomes exercisable shall be rounded down to the nearest whole share. Once the Option has become exercisable in accordance with this subparagraph 2(b) it shall continue to be exercisable until the termination of Participant’s rights hereunder pursuant to paragraph 3, 4 or 5 or until the Option has expired pursuant to subparagraph 2(a). A partial exercise of the Option shall not affect Participant’s right to exercise the Option with respect to the remaining shares, subject to the conditions of this Agreement.
c.Method of Exercising Option and Payment for Shares. The Option shall be exercised by written notice in the form of Attachment A — “Notice of Option Exercise” or such other form as may be approved by the Company, delivered to the attention of the Company’s Chief Financial Officer at the Company’s principal place of business. The exercise date shall be (i) in the case of notice by mail, the date of postmark, or (ii) if delivered in person, the date of delivery. Such notice shall be accompanied by payment of the Option price in full, in cash or cash equivalent acceptable to the Compensation Committee of the Company’s Board of


Directors (the “Compensation Committee” and the “Board”), or such other method as determined by the Compensation Committee, including an irrevocable commitment by a broker to pay over such amount from a sale of the shares of Common Stock issuable under the Option, the delivery of previously owned shares of Common Stock or withholding of shares of Common Stock deliverable upon exercise which, together with any cash or cash equivalent paid, is not less than the Option price for the number of shares for which the Option is being exercised.
d.Agreement with Terms. Execution of this Agreement by Participant or receipt of any benefits under this Agreement by Participant shall constitute Participant’s acknowledgement of, and agreement with, all of the provisions of this Agreement, and the Company shall administer this Agreement accordingly.
e.Shareholder Rights. Participant shall not have any rights as a shareholder with respect to shares subject to the Option until Participant exercises such Option and becomes the holder of record of such shares.
f.Forfeiture. In the event of Participant’s termination of employment, any vested portion of the Option that is not exercised during the period specified in paragraph 3, paragraph 4 or paragraph 5, as applicable, shall be forfeited upon the expiration of such period. Any portion of the Option that is unvested as of the date of Participant’s termination of employment shall be forfeited on such date.
3.Exercise in the Event of Death. In the event Participant dies before the expiration of the Option pursuant to subparagraph 2(a), the Option shall be exercisable with respect to all or part of the shares of Common Stock that Participant was entitled to purchase under subparagraph 2(b) on the date of Participant’s death. In that event, the Option may be exercised, to the extent exercisable under subparagraph 2(b), by Participant’s estate or by the other person or persons to whom Participant’s rights under the Option shall pass by will or the laws of descent and distribution. Participant’s estate or such persons may exercise the Option within one year after Participant’s death or during the remainder of the period preceding the Expiration Date, whichever is shorter.
4.Exercise in the Event of Permanent and Total Disability. In the event Participant becomes permanently and totally disabled within the meaning of Section 22(e)(3) of the Code (“Permanently and Totally Disabled”) before the expiration of the Option pursuant to subparagraph 2(a), the Option shall be exercisable with respect to all or part of the shares of Common Stock that Participant was entitled to purchase under subparagraph 2(b) on the date Participant ceases to be employed by the Company or, as determined by the Compensation Committee from time to time, any entity in which the Company has a substantial direct or indirect equity interest (an “Affiliate”), as a result of Participant’s becoming Permanently and Totally Disabled. In that event, Participant may exercise the Option, to the extent exercisable under subparagraph 2(b), within one year after the date Participant ceases to be employed by the Company and its Affiliates as a result of Participant’s becoming Permanently and Totally Disabled or during the period preceding the Expiration Date, whichever is shorter.
5.Exercise After Termination of Employment. Except as provided in paragraphs 3 and 4 hereof, if Participant ceases to be employed by the Company and its Affiliates prior to the Expiration Date, the Option shall be exercisable for all or part of the number of shares that Participant was entitled to purchase under subparagraph 2(b) and, if applicable, any additional number of shares specified under the Employment Agreement on the date of Participant’s termination of employment. In that event, Participant may exercise the Option, to the extent exercisable under subparagraph 2(b) and/or under the Employment Agreement, during the remainder of the period preceding the Expiration Date or until the date that is three months (or such other period of time provided under the Employment Agreement, if
2

any) after the date Participant ceases to be employed by the Company and its Affiliates, whichever is shorter.
6.Notice. Any notice or other communication given pursuant to this Agreement shall be in writing and shall be personally delivered or mailed by United States registered or certified mail, postage prepaid, return receipt requested, to the Company at its principal place of business or to Participant at the address on the payroll records of the Company or, in either case, at such other address as one party may subsequently furnish to the other party in writing. Additionally, if such notice or communication is by the Company to Participant, the Company may provide such notice electronically (including via email). Any such notice shall be deemed to have been given (a) on the date of postmark, in the case of notice by mail, or (b) on the date of delivery, if delivered in person or electronically.
7.Fractional Shares. Fractional shares shall not be issuable hereunder, and when any provision hereof may entitle Participant to a fractional share such fraction shall be disregarded.
8.No Right to Continued Employment. Nothing in this Agreement shall interfere with or limit in any way the right of the Company, its subsidiaries and/or its Affiliates to terminate Participant’s employment at any time or for any reason in accordance with the Company’s Bylaws, governing law and the Employment Agreement, nor shall any terms of this Agreement confer upon Participant any right to continue Participant’s employment for any specified period of time. Neither this Agreement nor any benefits arising under this Agreement shall constitute an employment contract with the Company or any of its subsidiaries or Affiliates.
9.Change in Capital Structure. The terms of the Option (including the number or kind of shares subject hereto and the option price) shall be equitably adjusted as the Compensation Committee determines is equitably required to reflect any reorganization, reclassification, combination of shares, stock split, reverse stock split, spin-off, dividend or distribution of securities, property or cash (other than regular, quarterly cash dividends), or any other event or transaction that affects the number or kind of shares of Common Stock outstanding. No fractional shares of Common Stock shall be issued pursuant to such an adjustment.
10.Change in Control. The Compensation Committee shall have the discretion to determine the treatment of the Option upon the occurrence of a Change in Control (as defined below). Unless otherwise expressly provided in the Employment Agreement or under the terms of a transaction constituting a Change in Control, the following shall occur upon a Participant’s involuntary termination of employment within twenty-four (24) months following a Change in Control, provided that such termination does not result from the Participant’s termination for disability, cause or gross misconduct: the Option shall immediately become exercisable and shall remain exercisable for three (3) years following such termination (or until the Expiration Date, if earlier). For purposes of this paragraph 10, the following definitions apply, subject to applicable laws to the extent mandatory:
a. “Change in Control” means the occurrence of any one of the following:
i.any Person becomes the beneficial owner (as such term is defined in Rule 13d-3 under the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”)) of at least 50% of either (A) the value of the then outstanding shares of common stock of the Company (the “Outstanding Company Common Stock”) or (B) the combined voting power of the then outstanding voting securities of the Company entitled to vote generally in the election of directors
3

(the “Outstanding Company Voting Securities”) (the foregoing beneficial ownership hereinafter being referred to as a “Controlling Interest”); provided, however, that for purposes of this definition, the following acquisitions shall not constitute or result in a Change in Control: (v) any acquisition directly from the Company; (w) any acquisition by the Company; (x) any acquisition by any person that as of the Date of Grant has beneficial ownership of a Controlling Interest; (y) any acquisition by any employee benefit plan (or related trust) sponsored or maintained by the Company or any Affiliate; or (z) any acquisition by any corporation pursuant to a transaction which complies with subparagraphs 10(b)(iii)(A), (B) and (C) below; or
ii.during any period of two consecutive years (not including any period prior to the Date of Grant) individuals who constitute the Board on the Date of Grant (the “Incumbent Board”) cease for any reason to constitute at least a majority of the Board; provided, however, that any individual becoming a director subsequent to the Date of Grant whose election, or nomination for election by the Company’s shareholders, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a Person other than the Board; or
iii.consummation of a reorganization, merger, statutory share exchange or consolidation or similar corporate transaction involving the Company or any of its subsidiaries, a sale or other disposition of all or substantially all of the assets of the Company, or the acquisition of assets or stock of another entity by the Company or any of its subsidiaries (each a “Business Combination”), in each case, unless, following such Business Combination, (A) all or substantially all of the Persons who were the beneficial owners, respectively, of the Outstanding Company Common Stock and Outstanding Company Voting Securities immediately prior to such Business Combination beneficially own, directly or indirectly, more than 50% of the then outstanding shares of common stock and the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors, as the case may be, of the corporation resulting from such Business Combination (including, without limitation, a corporation which as a result of such transaction owns the Company or all or substantially all of the Company’s assets either directly or through one or more subsidiaries) (such resulting or acquiring corporation is referred to herein as the “Acquiring Corporation”) in substantially the same proportions as their ownership, immediately prior to such Business Combination of the Outstanding Company Common Stock and Outstanding Company Voting Securities, as the case may be, (B) no Person (excluding the Acquiring Corporation or any employee benefit plan (or related
4

trust) of the Company or such Acquiring Corporation) beneficially owns, directly or indirectly, more than 50% of the then outstanding shares of common stock of the corporation resulting from such Business Combination or the combined voting power of the then outstanding voting securities of such corporation except to the extent that such ownership existed prior to the Business Combination, and (C) at least a majority of the members of the board of the corporation resulting from such Business Combination were members of the Incumbent Board at the time of the execution of the initial agreement, or of the action of the Board, providing for such Business Combination; or
iv.the complete liquidation or dissolution of the Company.
Notwithstanding the foregoing, to the extent required to avoid the imposition of additional taxes and/or penalties pursuant to Section 409A of the Code, no event or transaction will constitute a Change in Control hereunder unless it also constitutes a “change in control event” under Section 409A of the Code.
b. “Person” has the meaning given in Section 3(a)(9) of the Exchange Act, as modified and used in Sections 13(d) and 14(d) thereof, except that such term shall not include (i) the Company or any of its Affiliates, (ii) a trustee or other fiduciary holding securities under an employee benefit plan of the Company or any of its Subsidiaries, (iii) an underwriter temporarily holding securities pursuant to an offering of such securities or (iv) a corporation owned, directly or indirectly, by the shareholders of the Company in substantially the same proportions as their ownership of stock of the Company.
11.Tax Withholding. To the extent required by applicable federal, state, local or foreign law, the Company may and/or Participant shall make arrangements satisfactory to the Company for the satisfaction of any withholding tax obligations that arise with respect to the Option, or the issuance or sale of any shares of Common Stock. The Company shall not be required to recognize any Participant rights under the Option, to issue shares of Common Stock or to recognize the disposition of such shares of Common Stock until such obligations are satisfied. To the extent permitted or required by the Company, these obligations may or shall be satisfied by the Company withholding cash from any compensation otherwise payable to or for the benefit of Participant in accordance with applicable law, the Company withholding a portion of the shares of Common Stock that otherwise would be issued to a Participant under the Option or any other award held by Participant or by Participant tendering to the Company cash or, if allowed by the Company, shares of Common Stock. Nothing in this Agreement shall be interpreted or construed to transfer any liability for any tax (including, without limitation, a tax or penalty due as a result of a failure to comply with Section 409A of the Code) due by Participant to the Company, any subsidiary thereof or any Affiliate, or to any other individual or entity, and the Company shall have no liability to Participant, or any other party, with respect thereto. Participant acknowledges that the Company and its subsidiaries and Affiliates: (a) make no representations or undertakings regarding the tax treatment in connection with any aspect of the Option and (b) do not commit to structure the terms of the grant or any other aspect of the Option to reduce or eliminate Participant’s tax liabilities.
12.Administration. Any question concerning the interpretation of this Agreement or the Option, any adjustments required to be made to the Option hereunder, and any controversy that may arise with respect to the Option will be determined by the Compensation Committee in its sole and absolute discretion. All decisions by the Compensation Committee shall be final and binding on Participant and Participant’s beneficiaries, heirs and assigns.
5

13.Compliance with Laws and Regulations. Participant hereby acknowledges, represents and warrants to the Company that, unless a registration statement under the Securities Act of 1933, as amended (the “Securities Act”), with respect to the shares of Common Stock to be received upon the exercise of the Option is effective and current at the time of exercise of the Option, (i) the shares of Common Stock to be issued upon the exercise of the Option will be unregistered and acquired by Participant for Participant’s own account, for investment only and not with a view to the resale or distribution thereof and (ii) the shares of Common Stock to be issued upon the exercise of the Option may not be sold or transferred unless a registration statement under the Securities Act with respect to the resale of such shares is effective and current or such registration is determined by the Company to be unnecessary. Nothing herein shall be construed as requiring the Company to register the shares subject to the Option for sale or resale under the Securities Act. Notwithstanding anything herein to the contrary, if at any time the Company shall determine, in its sole discretion, that the listing or qualification of the shares of Common Stock subject to the Option on any securities exchange or under any applicable law, or the consent or approval of any governmental agency or regulatory body, is necessary or desirable as a condition to, or in connection with, the issuance of shares of Common Stock hereunder, the Option may not be exercised in whole or in part unless such listing, qualification, consent or approval shall have been effected or obtained free of any conditions not acceptable to the Company.
14.Governing Law. This Agreement shall be governed by the laws of the Commonwealth of Virginia, without regard to any rule or principle of conflicts of laws that otherwise would result in the application of the substantive laws of another jurisdiction. Any reference in this Agreement to a provision of law or to a rule or regulation shall be deemed to include any successor law, rule or regulation of similar effect or applicability.
15.Section 409A. It is intended that the provisions of this Agreement comply with Section 409A of the Code (“Section 409A”), and all provisions of the Option shall be construed and interpreted in a manner consistent with the requirements for avoiding taxes or penalties under Section 409A.
16.Nontransferability.  This Option may not be sold, transferred, pledged, assigned, or otherwise alienated or hypothecated by Participant except by will or by the laws of descent and distribution.  During Participant’s lifetime, this Option may be exercised only by Participant.
17.Acknowledgement. Participant acknowledges and agrees that Participant has no right to receive any equity compensation following the Date of Grant other than as set forth in this Agreement or otherwise approved by the Board or Compensation Committee on or before the Date of Grant, and that the Option is granted in full satisfaction of Participant’s right, if any, to an equity award under any offer letter, transition letter, or similar letter, agreement, or communication from the Company or any Affiliate.
18.Binding Effect. Subject to the limitations stated above, this Agreement shall be binding upon and inure to the benefit of the legatees, distributees, and personal representatives of Participant and the successors of the Company.
IN WITNESS WHEREOF, the Company has caused this Agreement to be signed by a duly authorized officer, and Participant has affixed Participant’s signature hereto.




6







INSMED INCORPORATED


By: /s/ Sara Bonstein
Chief Financial Officer



PARTICIPANT

/s/ /$ParticipantName$/

7


Attachment A
Chief Financial Officer
Insmed Incorporated
700 US Highway 202/206
Bridgewater, NJ 08807
Notice Of Option Exercise
This letter is notice of my decision to exercise the Option that was granted to me on ______________. Terms used but not defined in this notice have the meanings given to them in the Nonqualified Stock Option Inducement Award Agreement between the Company and myself on _______________. The exercise will be effective on _____________. I am exercising the Option for ______________ shares of Common Stock. I have chosen the following form of payment to cover the aggregate Option price for the number of shares for which I am exercising the Option (check one):
[ ]    1.     Cash
    [ ]    2.    Certified or bank check payable to Insmed Incorporated    
    [ ]    3.    Other (please describe):
        ______________________________________________________


Sincerely,


                                                                                   
Name:
Address:


Accepted by:
Date:

Note: The date of exercise cannot be earlier than the date of delivery of this notice or the postmark, if the notice is mailed.
8

INSMED INCORPORATED
NONQUALIFIED STOCK OPTION INDUCEMENT AWARD AGREEMENT
No. of shares subject to Option: /$AwardsGranted$/

THIS AGREEMENT dated this /$GrantDate$/ (this “Agreement”), between INSMED INCORPORATED, a Virginia corporation (the “Company”), and /$ParticipantName$/ (the “Participant”), is an inducement material to Participant’s entry into employment with the Company or a subsidiary of the Company within the meaning of Rule 5635(c)(4) of the NASDAQ Listing Rules (the “Inducement Award Rule”). If and to the extent that this Agreement conflicts or is inconsistent with the terms, conditions and provisions of Participant’s offer letter or employment agreement with the Company or the applicable subsidiary thereof, dated as of /$HireDate$/ (the “Employment Agreement”), the Employment Agreement shall control, and this Agreement shall be deemed to be modified accordingly so long as such modification is consistent with the Inducement Award Rule and applicable law.

1.Grant of Option. The Company, on /$GrantDate$/ (the “Date of Grant”), granted to Participant, subject to the terms and conditions herein set forth, the right and option to purchase from the Company all or any part of an aggregate of /$AwardsGranted$/ shares of common stock of the Company, par value US $0.01 per share (the “Common Stock”) at the option price of /$GrantPrice$/ per share, being not less than the closing price of a share of the Company’s Common Stock on the NASDAQ on the Date of Grant (the “Option”). The Option is intended to be a nonqualified stock option and not an “incentive stock option” within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”). The Option is exercisable as hereinafter provided.
2.Terms and Conditions. The Option is subject to the following terms and conditions:
a.Expiration Date. The Option shall expire ten years from the Date of Grant (the “Expiration Date”).
b.Exercise of Option. Except as provided in paragraphs 3, 4 and 5, the Option shall be exercisable with respect to twenty-five percent (25%) of the shares of Common Stock subject to the Option on the first annual anniversary of the Date of Grant (the “First Anniversary Date”) and with respect to twelve and a half percent (12.5%) of the shares of Common Stock subject to the Option on the six-month anniversary of the First Anniversary Date and each six-month anniversary date thereafter through the fourth annual anniversary of the Date of Grant, subject to Participant’s continued employment through each applicable date. If the foregoing schedule would produce fractional shares, the number of shares for which the Option becomes exercisable shall be rounded down to the nearest whole share. Once the Option has become exercisable in accordance with this subparagraph 2(b) it shall continue to be exercisable until the termination of Participant’s rights hereunder pursuant to paragraph 3, 4 or 5 or until the Option has expired pursuant to subparagraph 2(a). A partial exercise of the Option shall not affect Participant’s right to exercise the Option with respect to the remaining shares, subject to the conditions of this Agreement.
c.Method of Exercising Option and Payment for Shares. The Option shall be exercised by written notice in the form of Attachment A — “Notice of Option Exercise” or such other form as may be approved by the Company, delivered to the attention of the Company’s Chief Financial Officer at the Company’s principal place of business. The exercise date shall be (i) in the case of notice by mail, the date of postmark, or (ii) if delivered in person, the date of delivery. Such notice shall be accompanied by payment of the Option price in full, in cash or cash equivalent acceptable to the Compensation Committee of the Company’s Board of


Directors (the “Compensation Committee” and the “Board”), or such other method as determined by the Compensation Committee, including an irrevocable commitment by a broker to pay over such amount from a sale of the shares of Common Stock issuable under the Option, the delivery of previously owned shares of Common Stock or withholding of shares of Common Stock deliverable upon exercise which, together with any cash or cash equivalent paid, is not less than the Option price for the number of shares for which the Option is being exercised.
d.Agreement with Terms. Execution of this Agreement by Participant or receipt of any benefits under this Agreement by Participant shall constitute Participant’s acknowledgement of, and agreement with, all of the provisions of this Agreement, and the Company shall administer this Agreement accordingly.
e.Shareholder Rights. Participant shall not have any rights as a shareholder with respect to shares subject to the Option until Participant exercises such Option and becomes the holder of record of such shares.
f.Forfeiture. In the event of Participant’s termination of employment, any vested portion of the Option that is not exercised during the period specified in paragraph 3, paragraph 4 or paragraph 5, as applicable, shall be forfeited upon the expiration of such period. Any portion of the Option that is unvested as of the date of Participant’s termination of employment shall be forfeited on such date.
3.Exercise in the Event of Death. In the event Participant dies before the expiration of the Option pursuant to subparagraph 2(a), the Option shall be exercisable with respect to all or part of the shares of Common Stock that Participant was entitled to purchase under subparagraph 2(b) on the date of Participant’s death. In that event, the Option may be exercised, to the extent exercisable under subparagraph 2(b), by Participant’s estate or by the other person or persons to whom Participant’s rights under the Option shall pass by will or the laws of descent and distribution. Participant’s estate or such persons may exercise the Option within one year after Participant’s death or during the remainder of the period preceding the Expiration Date, whichever is shorter.
4.Exercise in the Event of Permanent and Total Disability. In the event Participant becomes permanently and totally disabled within the meaning of Section 22(e)(3) of the Code (“Permanently and Totally Disabled”) before the expiration of the Option pursuant to subparagraph 2(a), the Option shall be exercisable with respect to all or part of the shares of Common Stock that Participant was entitled to purchase under subparagraph 2(b) on the date Participant ceases to be employed by the Company or, as determined by the Compensation Committee from time to time, any entity in which the Company has a substantial direct or indirect equity interest (an “Affiliate”), as a result of Participant’s becoming Permanently and Totally Disabled. In that event, Participant may exercise the Option, to the extent exercisable under subparagraph 2(b), within one year after the date Participant ceases to be employed by the Company and its Affiliates as a result of Participant’s becoming Permanently and Totally Disabled or during the period preceding the Expiration Date, whichever is shorter.
5.Exercise After Termination of Employment. Except as provided in paragraphs 3 and 4 hereof, if Participant ceases to be employed by the Company and its Affiliates prior to the Expiration Date, the Option shall be exercisable for all or part of the number of shares that Participant was entitled to purchase under subparagraph 2(b) and, if applicable, any additional number of shares specified under the Employment Agreement on the date of Participant’s termination of employment. In that event, Participant may exercise the Option, to the extent exercisable under subparagraph 2(b) and/or under the Employment Agreement, during the remainder of the period preceding the Expiration Date or until the date that is three months (or such other period of time provided under the Employment Agreement, if
2

any) after the date Participant ceases to be employed by the Company and its Affiliates, whichever is shorter.
6.Notice. Any notice or other communication given pursuant to this Agreement shall be in writing and shall be personally delivered or mailed by United States registered or certified mail, postage prepaid, return receipt requested, to the Company at its principal place of business or to Participant at the address on the payroll records of the Company or, in either case, at such other address as one party may subsequently furnish to the other party in writing. Additionally, if such notice or communication is by the Company to Participant, the Company may provide such notice electronically (including via email). Any such notice shall be deemed to have been given (a) on the date of postmark, in the case of notice by mail, or (b) on the date of delivery, if delivered in person or electronically.
7.Fractional Shares. Fractional shares shall not be issuable hereunder, and when any provision hereof may entitle Participant to a fractional share such fraction shall be disregarded.
8.No Right to Continued Employment. Nothing in this Agreement shall interfere with or limit in any way the right of the Company, its subsidiaries and/or its Affiliates to terminate Participant’s employment at any time or for any reason in accordance with the Company’s Bylaws, governing law and the Employment Agreement, nor shall any terms of this Agreement confer upon Participant any right to continue Participant’s employment for any specified period of time. Neither this Agreement nor any benefits arising under this Agreement shall constitute an employment contract with the Company or any of its subsidiaries or Affiliates.
9.Change in Capital Structure. The terms of the Option (including the number or kind of shares subject hereto and the option price) shall be equitably adjusted as the Compensation Committee determines is equitably required to reflect any reorganization, reclassification, combination of shares, stock split, reverse stock split, spin-off, dividend or distribution of securities, property or cash (other than regular, quarterly cash dividends), or any other event or transaction that affects the number or kind of shares of Common Stock outstanding. No fractional shares of Common Stock shall be issued pursuant to such an adjustment.
10.Change in Control. The Compensation Committee shall have the discretion to determine the treatment of the Option upon the occurrence of a Change in Control (as defined below). Unless otherwise expressly provided in the Employment Agreement or under the terms of a transaction constituting a Change in Control, the following shall occur upon a Participant’s involuntary termination of employment within twenty-four (24) months following a Change in Control, provided that such termination does not result from the Participant’s termination for disability, cause or gross misconduct: the Option shall immediately become exercisable and shall remain exercisable for three (3) years following such termination (or until the Expiration Date, if earlier). For purposes of this paragraph 10, the following definitions apply, subject to applicable laws to the extent mandatory:
a. “Change in Control” means the occurrence of any one of the following:
i.any Person becomes the beneficial owner (as such term is defined in Rule 13d-3 under the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”)) of at least 50% of either (A) the value of the then outstanding shares of common stock of the Company (the “Outstanding Company Common Stock”) or (B) the combined voting power of the then outstanding voting securities of the Company entitled to vote generally in the election of directors
3

(the “Outstanding Company Voting Securities”) (the foregoing beneficial ownership hereinafter being referred to as a “Controlling Interest”); provided, however, that for purposes of this definition, the following acquisitions shall not constitute or result in a Change in Control: (v) any acquisition directly from the Company; (w) any acquisition by the Company; (x) any acquisition by any person that as of the Date of Grant has beneficial ownership of a Controlling Interest; (y) any acquisition by any employee benefit plan (or related trust) sponsored or maintained by the Company or any Affiliate; or (z) any acquisition by any corporation pursuant to a transaction which complies with subparagraphs 10(b)(iii)(A), (B) and (C) below; or
ii.during any period of two consecutive years (not including any period prior to the Date of Grant) individuals who constitute the Board on the Date of Grant (the “Incumbent Board”) cease for any reason to constitute at least a majority of the Board; provided, however, that any individual becoming a director subsequent to the Date of Grant whose election, or nomination for election by the Company’s shareholders, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a Person other than the Board; or
iii.consummation of a reorganization, merger, statutory share exchange or consolidation or similar corporate transaction involving the Company or any of its subsidiaries, a sale or other disposition of all or substantially all of the assets of the Company, or the acquisition of assets or stock of another entity by the Company or any of its subsidiaries (each a “Business Combination”), in each case, unless, following such Business Combination, (A) all or substantially all of the Persons who were the beneficial owners, respectively, of the Outstanding Company Common Stock and Outstanding Company Voting Securities immediately prior to such Business Combination beneficially own, directly or indirectly, more than 50% of the then outstanding shares of common stock and the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors, as the case may be, of the corporation resulting from such Business Combination (including, without limitation, a corporation which as a result of such transaction owns the Company or all or substantially all of the Company’s assets either directly or through one or more subsidiaries) (such resulting or acquiring corporation is referred to herein as the “Acquiring Corporation”) in substantially the same proportions as their ownership, immediately prior to such Business Combination of the Outstanding Company Common Stock and Outstanding Company Voting Securities, as the case may be, (B) no Person (excluding the Acquiring Corporation or any employee benefit plan (or related
4

trust) of the Company or such Acquiring Corporation) beneficially owns, directly or indirectly, more than 50% of the then outstanding shares of common stock of the corporation resulting from such Business Combination or the combined voting power of the then outstanding voting securities of such corporation except to the extent that such ownership existed prior to the Business Combination, and (C) at least a majority of the members of the board of the corporation resulting from such Business Combination were members of the Incumbent Board at the time of the execution of the initial agreement, or of the action of the Board, providing for such Business Combination; or
iv.the complete liquidation or dissolution of the Company.
Notwithstanding the foregoing, to the extent required to avoid the imposition of additional taxes and/or penalties pursuant to Section 409A of the Code, no event or transaction will constitute a Change in Control hereunder unless it also constitutes a “change in control event” under Section 409A of the Code.
b. “Person” has the meaning given in Section 3(a)(9) of the Exchange Act, as modified and used in Sections 13(d) and 14(d) thereof, except that such term shall not include (i) the Company or any of its Affiliates, (ii) a trustee or other fiduciary holding securities under an employee benefit plan of the Company or any of its Subsidiaries, (iii) an underwriter temporarily holding securities pursuant to an offering of such securities or (iv) a corporation owned, directly or indirectly, by the shareholders of the Company in substantially the same proportions as their ownership of stock of the Company.
11.Tax Withholding. To the extent required by applicable federal, state, local or foreign law, the Company may and/or Participant shall make arrangements satisfactory to the Company for the satisfaction of any withholding tax obligations that arise with respect to the Option, or the issuance or sale of any shares of Common Stock. The Company shall not be required to recognize any Participant rights under the Option, to issue shares of Common Stock or to recognize the disposition of such shares of Common Stock until such obligations are satisfied. To the extent permitted or required by the Company, these obligations may or shall be satisfied by the Company withholding cash from any compensation otherwise payable to or for the benefit of Participant in accordance with applicable law, the Company withholding a portion of the shares of Common Stock that otherwise would be issued to a Participant under the Option or any other award held by Participant or by Participant tendering to the Company cash or, if allowed by the Company, shares of Common Stock. Nothing in this Agreement shall be interpreted or construed to transfer any liability for any tax (including, without limitation, a tax or penalty due as a result of a failure to comply with Section 409A of the Code) due by Participant to the Company, any subsidiary thereof or any Affiliate, or to any other individual or entity, and the Company shall have no liability to Participant, or any other party, with respect thereto. Participant acknowledges that the Company and its subsidiaries and Affiliates: (a) make no representations or undertakings regarding the tax treatment in connection with any aspect of the Option and (b) do not commit to structure the terms of the grant or any other aspect of the Option to reduce or eliminate Participant’s tax liabilities.
12.Administration. Any question concerning the interpretation of this Agreement or the Option, any adjustments required to be made to the Option hereunder, and any controversy that may arise with respect to the Option will be determined by the Compensation Committee in its sole and absolute discretion. All decisions by the Compensation Committee shall be final and binding on Participant and Participant’s beneficiaries, heirs and assigns.
5

13.Compliance with Laws and Regulations. Participant hereby acknowledges, represents and warrants to the Company that, unless a registration statement under the Securities Act of 1933, as amended (the “Securities Act”), with respect to the shares of Common Stock to be received upon the exercise of the Option is effective and current at the time of exercise of the Option, (i) the shares of Common Stock to be issued upon the exercise of the Option will be unregistered and acquired by Participant for Participant’s own account, for investment only and not with a view to the resale or distribution thereof and (ii) the shares of Common Stock to be issued upon the exercise of the Option may not be sold or transferred unless a registration statement under the Securities Act with respect to the resale of such shares is effective and current or such registration is determined by the Company to be unnecessary. Nothing herein shall be construed as requiring the Company to register the shares subject to the Option for sale or resale under the Securities Act. Notwithstanding anything herein to the contrary, if at any time the Company shall determine, in its sole discretion, that the listing or qualification of the shares of Common Stock subject to the Option on any securities exchange or under any applicable law, or the consent or approval of any governmental agency or regulatory body, is necessary or desirable as a condition to, or in connection with, the issuance of shares of Common Stock hereunder, the Option may not be exercised in whole or in part unless such listing, qualification, consent or approval shall have been effected or obtained free of any conditions not acceptable to the Company.
14.Governing Law. This Agreement shall be governed by the laws of the Commonwealth of Virginia, without regard to any rule or principle of conflicts of laws that otherwise would result in the application of the substantive laws of another jurisdiction. Any reference in this Agreement to a provision of law or to a rule or regulation shall be deemed to include any successor law, rule or regulation of similar effect or applicability.
15.Section 409A. It is intended that the provisions of this Agreement comply with Section 409A of the Code (“Section 409A”), and all provisions of the Option shall be construed and interpreted in a manner consistent with the requirements for avoiding taxes or penalties under Section 409A.
16.Nontransferability.  This Option may not be sold, transferred, pledged, assigned, or otherwise alienated or hypothecated by Participant except by will or by the laws of descent and distribution.  During Participant’s lifetime, this Option may be exercised only by Participant.
17.Acknowledgement. Participant acknowledges and agrees that Participant has no right to receive any equity compensation following the Date of Grant other than as set forth in this Agreement or otherwise approved by the Board or Compensation Committee on or before the Date of Grant, and that the Option is granted in full satisfaction of Participant’s right, if any, to an equity award under any offer letter, transition letter, or similar letter, agreement or communication from the Company or any Affiliate.
18.Binding Effect. Subject to the limitations stated above, this Agreement shall be binding upon and inure to the benefit of the legatees, distributees, and personal representatives of Participant and the successors of the Company.
19.Non-U.S. Participant. Notwithstanding the provisions in this Agreement, if Participant resides and/or works outside the United States, the Option shall be subject to the special terms and conditions set forth in Attachment B. Moreover, if Participant relocates to one of the jurisdictions included in Attachment B, the special terms and conditions for such jurisdiction will apply to Participant, to the extent the Company determines that the application of such terms and conditions is necessary or advisable for legal or administrative reasons.
6

IN WITNESS WHEREOF, the Company has caused this Agreement to be signed by a duly authorized officer, and Participant has affixed Participant’s signature hereto.




INSMED INCORPORATED


By: /s/ Sara Bonstein
Chief Financial Officer



PARTICIPANT

/s/ /$ParticipantName$/

7


Attachment A
Chief Financial Officer
Insmed Incorporated
700 US Highway 202/206
Bridgewater, NJ 08807
Notice Of Option Exercise
This letter is notice of my decision to exercise the Option that was granted to me on ______________. Terms used but not defined in this notice have the meanings given to them in the Nonqualified Stock Option Inducement Award Agreement between the Company and myself on _______________. The exercise will be effective on _____________. I am exercising the Option for ______________ shares of Common Stock. I have chosen the following form of payment to cover the aggregate Option price for the number of shares for which I am exercising the Option (check one):
[ ]    1.     Cash
    [ ]    2.    Certified or bank check payable to Insmed Incorporated    
    [ ]    3.    Other (please describe):
        ______________________________________________________


Sincerely,


                                                                                   
Name:
Address:


Accepted by:
Date:

Note: The date of exercise cannot be earlier than the date of delivery of this notice or the postmark, if the notice is mailed.

8

Attachment B
SPECIAL TERMS AND CONDITIONS FOR NON-U.S. PARTICIPANTS
This Attachment B includes special terms and conditions that supplement the terms and conditions in the Agreement for any Participant who resides and/or works outside of the United States. Capitalized terms used but not defined herein shall have the meanings assigned to them in the Agreement (of which this Attachment B is a part). The information is general in nature and may not apply to Participant’s particular situation, and the Company is not in a position to assure Participant of any particular result. Accordingly, Participant should seek appropriate professional advice as to how the relevant laws in Participant’s country apply to Participant’s specific situation.
ALL COUNTRIES OUTSIDE THE UNITED STATES
1.Tax Withholding. As a condition to the exercise of the Option, Participant agrees to make adequate provision for all income tax, social insurance, social contribution, payroll tax, fringe benefits tax, payment on account, or other tax-related items related to the Option and legally applicable to Participant (“Tax-Related Items”). Participant acknowledges that, regardless of any action taken by the Company or, if different, any Affiliate of the Company to whom Participant is rendering services (the “Service Recipient”), the ultimate liability for all Tax-Related Items is and remains Participant’s responsibility and may exceed the amount actually withheld by the Company or the Service Recipient. Participant further acknowledges that the Company and/or the Service Recipient (i) make no representations or undertakings regarding the treatment of any Tax-Related Items in connection with any aspect of the Option, including, but not limited to, the grant, vesting, or exercise of the Option; the subsequent sale of shares acquired pursuant to such exercise; and the receipt of any dividends; and (ii) do not commit to and are under no obligation to structure the terms of the grant or any aspect of the Option to reduce or eliminate Participant’s liability for Tax-Related Items or achieve any particular tax result. Further, if Participant is subject to Tax-Related Items in more than one jurisdiction, Participant acknowledges that the Company and/or the Service Recipient (or former service recipient, as applicable) may be required to withhold or account for Tax-Related Items in more than one jurisdiction. Prior to the relevant taxable or tax withholding event, as applicable, Participant agrees to make adequate arrangements satisfactory to the Company and/or the Service Recipient to satisfy all Tax-Related Items. In this regard, Participant authorizes the Company and/or the Service Recipient, or their respective agents, at their discretion, to satisfy the obligations with regard to all Tax-Related Items by (to the maximum extent permitted by applicable law): (i) requiring a cash payment paid by Participant; (ii) withholding from Participant’s wages or other cash compensation paid to Participant by the Company and/or any Affiliate of the Company; (iii) withholding from proceeds of the sale of shares acquired at exercise of the Option either through a broker-assisted cashless exercise (provided that a public market for the Common Stock exists) or other voluntary sale, mandatory sale, or other cashless exercise method arranged by the Company (in each case on Participant’s behalf pursuant to this authorization and without further consent); and/or (iv) withholding from the shares to be issued upon exercise. Depending on the withholding method, the Company may withhold or account for Tax-Related Items by considering applicable statutory withholding amounts or other applicable withholding rates, including maximum applicable rates, in which case Participant will receive a refund of any over-withheld amount in cash and will have no entitlement to the Common Stock equivalent. If the obligation for Tax-Related Items is satisfied by withholding shares, for tax purposes, Participant is deemed to have been issued the full number of shares subject to the exercised Option, notwithstanding that a number of the shares are held back solely for the purpose of paying the Tax-Related Items. Finally, Participant agrees to pay to the Company and/or the Service Recipient any amount of Tax-Related Items that the Company
9

and/or the Service Recipient may be required to withhold or account for as a result of the Option that cannot be satisfied by the means previously described. The Company may refuse to issue or deliver the shares or the proceeds of the sale of shares if Participant fails to comply with Participant’s obligations in connection with the Tax-Related Items.
2.Not a Public Offering. The grant of the Option is not intended to be a public offering of securities in Participant’s country of employment (or country of residence, if different). The Company has not submitted any registration statement, prospectus, or other filings with the local securities authorities (unless otherwise required under local law), and the grant of the Option is not subject to the supervision of the local securities authorities.
3.No Advice Regarding Option. Investment in shares of the Company’s Common Stock involves a degree of risk. Before deciding to acquire shares by exercising the Option, Participant should carefully consider all risk factors relevant to the acquisition of shares of the Company’s Common Stock and carefully review all of the materials related to the Option. The Company is not providing any tax, legal, or financial advice, nor is the Company making any recommendations regarding Participant’s participation in the Agreement, or Participant’s acquisition or sale of the shares underlying the Option. Participant is hereby advised to consult with Participant’s own personal tax, legal, and financial advisors regarding Participant’s participation in the Agreement before taking any action related to the Option.
4.Language. If Participant has received this Agreement, or any other document related to this Option, translated into a language other than English and if the meaning of the translated version is different than the English version, the English version will control.
5.Termination of Service. For purposes of the Option, Participant’s service will be considered terminated as of the earlier of (i) the date Participant receives notice of termination from the Company or Service Recipient or (ii) the date Participant is no longer actively providing services to the Company or one of its Affiliates (regardless of the reason for such termination and whether or not later found to be invalid or in breach of employment laws in the jurisdiction where Participant is engaged or the terms of the Employment Agreement) and, unless otherwise expressly provided in the Agreement or determined by the Company, Participant’s right to vest in the Option under the Agreement, if any, will terminate as of such date and will not be extended by any notice period (e.g., Participant’s period of service would not include any contractual notice period or any period of “garden leave” or similar period mandated under employment laws or other laws in the jurisdiction where Participant is engaged). The Company shall have the exclusive discretion to determine when Participant is no longer actively providing services for purposes of the Option (including whether Participant may still be considered to be providing services while on an approved leave of absence). Notwithstanding the foregoing, if applicable local law explicitly requires continued vesting during a statutory notice period, Participant’s right to vest in the Option under the Agreement, if any, will terminate effective as of the last day of Participant’s minimum statutory notice period.
6.Imposition of Additional Requirements; Repatriation; Compliance with Law. The grant of the Option and the issuance and delivery of shares under the Option are subject to all applicable laws, rules, and regulations and to such approvals by any governmental agencies or securities exchange as may be required. Notwithstanding any provision of the Agreement, the Company has no liability to deliver any shares under the Option or make any payment unless such delivery or payment would comply with all laws and the applicable requirements of any governmental agency, securities exchange, or similar entity, and unless and until Participant has taken all actions required by the Company in connection with the Option. The Company reserves the right to impose other requirements on the Option and on the shares acquired upon the exercise of the Option to the extent the Company determines it is
10

necessary or advisable for legal or administrative reasons, and to require Participant to sign any additional agreements or undertakings that may be necessary to accomplish the foregoing. Participant agrees to repatriate all payments attributable to the shares and/or cash acquired under the Option in accordance with applicable foreign exchange rules and regulations in Participant’s country of employment (and country of residence, if different). In addition, Participant agrees to take any and all actions, and consents to any and all actions taken by the Company and any of its affiliates, as may be required to allow the Company and any of its Affiliates to comply with local laws, rules, and/or regulations in Participant’s country of employment (and country of residence, if different). Finally, Participant agrees to take any and all actions as may be required to comply with Participant’s personal obligations under local laws, rules, and/or regulations in Participant’s country of employment (and country of residence, if different). Neither the Company nor any of its Affiliates shall be liable for any costs, fines, or penalties resulting from Participant’s failure to comply with such personal obligations.
7.Foreign Asset and Account Reporting. Participant’s country of employment (and country of residence, if different) may have certain exchange control and/or foreign asset/account reporting requirements which may affect Participant’s ability to acquire or hold shares under the Option or cash received in connection with the Option (including from any dividends received or sale proceeds resulting from the sale of shares) in a brokerage or bank account outside of Participant’s country. Participant may be required to report such accounts, assets, or transactions to the tax or other authorities in Participant’s country. Participant acknowledges that it is Participant’s responsibility to comply with any applicable regulations, and that Participant should speak to Participant’s personal advisor on this matter.
8.Acknowledgements. In accepting the Option, Participant acknowledges and agrees that:
a.the grant of the Option is exceptional, voluntary and occasional and does not create any contractual or other right to receive future grants of stock options, or benefits in lieu of stock options, even if stock options or other awards have been granted in the past;
b.all decisions with respect to future awards, if any, will be at the sole discretion of the Company;
c.Participant’s participation in the Agreement is voluntary;
d.the Option and Participant’s participation in the Agreement shall not create a right to employment or service or be interpreted as forming an employment contract with the Company or any of its Affiliates and shall not interfere with the ability of the Company or any of its Affiliates to terminate Participant’s employment relationship (as otherwise may be permitted under local law);
e.the Option and any shares acquired under the Option and the income and value of the same are not part of normal or expected compensation or remuneration for any purpose;
f.the future value of the shares underlying the Option is unknown, indeterminable, and cannot be predicted with certainty;
g.if the shares underlying the Option do not increase in value, the Option will have no value;
11

h.if Participant exercises the Option and acquires the underlying shares, the value of such shares may increase or decrease in value, even below the exercise price;
i.no claim or entitlement to compensation or damages shall arise from forfeiture of the Option resulting from termination of Participant’s employment (for any reason whatsoever and whether or not in breach of applicable laws or later found invalid) and, in consideration of the Option, Participant agrees not to institute any claim against the Company or any of its Affiliates;
j.the Option and the benefits evidenced by the Agreement do not create any entitlement not otherwise specifically provided for in the Agreement or provided by the Company in its discretion, to have the Option or any such benefits transferred to, or assumed by, another company, nor to be exchanged, cashed out or substituted for, in connection with any corporate transaction affecting the Common Stock; and
k.neither the Company nor any of its Affiliates shall be liable for any foreign exchange rate fluctuation between Participant’s local currency and the U.S. dollar that may affect the value of the Option or any amounts due to Participant pursuant to the exercise of the Option or the subsequent sale of any shares acquired upon exercise of the Option. To the extent the Company determines that a currency exchange or conversion is necessary in connection with the exercise of the Option or any other matter, such exchange shall be calculated and determined by the Company in its sole discretion, and the Company’s determination shall be final and binding.
ALL COUNTRIES IN THE EUROPEAN UNION
Participant understands and acknowledges that the Company shall collect, use, and transfer Participant’s personal information for the purpose of implementing the Agreement and administering Participant’s participation in the Option in accordance with the Insmed EU Employee Personal Data Processing Notice, a copy of which has been appended to the Agreement, if applicable to Participant.

12

AUSTRALIA
1.Securities Law Information. The offer of the Option is intended to comply with the provisions of the Corporations Act 2001, Australian Securities and Investments Commission (“ASIC”) Regulatory Guide 49 and/or ASIC Class Order CO 14/1000. If Participant acquires shares under the Option and offers such shares for sale to a person or entity resident in Australia, the offer may be subject to disclosure requirements under Australian law. Participant should obtain legal advice on disclosure obligations prior to making any such offer.
2.Breach of Law. Notwithstanding anything to the contrary in the Agreement, Participant will not be entitled to, and shall not claim any benefit (including without limitation a legal right) under the Agreement if the provision of such benefit would give rise to a breach of Part 2D.2 of the Corporations Act 2001 (Cth), any other provision of that Act, or any other applicable statute, rule or regulation which limits or restricts the giving of such benefits.
3.Tax Information. The Option is an award to which Subdivision 83A-C of the Income Tax Assessment Act 1997 (Cth) applies (subject to the conditions in such Act).
BELGIUM
1.Tax Information. The Participant agrees and acknowledges that the Company will only accept a countersigned Agreement after the 60th day following the Participant’s receipt of the Agreement. By formally accepting in writing the Agreement through signature and by returning it to the Company within 60 days from receipt of the Agreement, the Participant would normally become subject to income tax on a lump-sum benefit in kind on the 60th day following receipt of the Agreement (being the “grant date” for Belgian tax purposes). In that case, no taxation should be triggered upon vesting or exercise. However, if written acceptance and return of the Agreement would take place after the 60th day following receipt of the Agreement, as required by the Company, taxation will normally be delayed to the date of exercise of this Option. In that case, grant or vesting should not trigger taxation.

CANADA
1.Data Privacy. Participant hereby authorizes the Company and the Company’s representatives to discuss with and obtain all relevant information from all personnel, professional or not, involved in the administration and operation of the Agreement and the Option. Participant further authorizes the Company and any of its Affiliates and the Compensation Committee to disclose and discuss the Agreement and the Option with their advisors. Participant further authorizes the Company and any of its Affiliates to record such information and to keep such information in Participant’s employee file.
2.English Language Consent - Quebec. The parties acknowledge that it is their express wish that the Agreement, as well as all documents, notices, and legal proceedings entered into, given, or instituted pursuant hereto or relating directly or indirectly hereto, be drawn up in English.
Les parties reconnaissent avoir expressement souhaité que la convention (le « Agreement »), ainsi que tous les documents, avis et procédures judiciaries, éxecutés, donnés ou intentés en vertu de, ou lié, directement ou indirectement à la présente convention, soient rédigés en langue anglaise.
FRANCE
13

1.Non-Qualification of Award. The Option is not intended to be tax qualified under French tax laws including, without limitation, under Articles L. 225-197-1 to L. 225-197-6 of the French Commercial Code.
2.Language Consent. In accepting the grant of the Option and this Agreement which provides for the terms and conditions of the Option, the Participant confirms that he or she has read and understood the documents relating to the Option (this Agreement), which were provided in the English language. The Participant accepts the terms of these documents accordingly.
Consentement Relatif à la Langue Utilisée. En acceptant cette attribution gratuite d’actions et ce contrat qui contient les termes et conditions de cette attribution gratuite d’actions, l’employé confirme ainsi avoir lu et compris les documents relatifs à cette attribution (le Contrat d’Attribution) qui lui ont été communiqués en langue anglaise. L’employé en accepte les termes en connaissance de cause.
GERMANY
No specific provisions.
IRELAND
No specific provisions.
ITALY
No specific provisions.
JAPAN
No specific provisions.
NETHERLANDS
image_0a.jpg
1.Waiver of Termination Rights. Participant hereby waives any and all rights to compensation or damages as a result of Participant’s termination of employment with the Company and its Affiliates for any reason whatsoever, insofar as those rights result or may result from (i) the loss or diminution in value of such rights or entitlements under the Option, or (ii) Participant’s ceasing to have rights under the Option as a result of such termination.
PORTUGAL
No specific provisions.
SWITZERLAND
14

1.Securities Law Information. Neither this Agreement nor any other materials relating to the Option (i) constitutes a prospectus according to articles 35 et seq. of the Swiss Federal Act on Financial Services (“FinSA”), (ii) may be publicly distributed or otherwise made publicly available in Switzerland to any person other than the Participant, or (iii) has been or will be filed with, approved or supervised by any Swiss reviewing body according to article 51 of FinSA or any Swiss regulatory authority, including the Swiss Financial Market Supervisory Authority (“FINMA”).
UNITED KINGDOM
1.Data Privacy. Participant understands and acknowledges that the Company shall collect, use, and transfer Participant’s personal information for the purpose of implementing the Agreement and administering Participant’s participation in the Option in accordance with the Insmed UK Employee Personal Data Processing Notice, a copy of which has been appended to the Agreement, if applicable to Participant.
2.National Insurance Contributions. The Company may require, as a condition of the exercise of the Option, that Participant shall, to the extent applicable:
a.agree to reimburse the Company in whole or in part for any employer’s secondary national insurance contributions arising on the exercise of the Option; or
b.enter into an election with the Company to assume in whole or part the liability for any secondary Class 1 national insurance contributions, payable on the exercise of the Option, including an election under paragraph 3B of Schedule 1 to the Social Security Contributions and Benefits Act 1992; or
c.agree to pay the employer’s national insurance contributions, social security contributions, and other levies and taxes arising on the exercise of the Option to the extent permitted by law, in any other jurisdiction.
3.Section 431 Election. Participant agrees that, if requested to do so by the Company, Participant shall immediately upon the exercise of the Option enter into an irrevocable joint election with the Company pursuant to section 431 of the U.K. Income Tax (Earnings and Pensions) Act 2003 (“ITEPA”) in a form specified by the Company that, for the relevant tax purposes, the market value of the share acquired is to be calculated as if the share were not restricted securities (as defined in section 423 of ITEPA) and sections 425 to 430 of ITEPA shall not apply to such shares.
4.Outstanding Amounts. If Participant fails to make payment to the Company in accordance with the “Tax Withholding” paragraph under the “All Countries Outside the United States” section of this Attachment B immediately upon request, Participant shall be liable to make good any amount outstanding on demand.


15

PERSONAL DATA PROCESSING- EMPLOYEE NOTICE (IRELAND ONLY)
As your employer, Insmed Ireland Ltd, with registered office in Dublin (the “Company”) collects, uses and discloses personal information relating to you. The Company is committed to ensure that your personal information will be handled in accordance with all applicable data protection laws.

The information that the Company holds on you, collected in both paper and electronic format, is limited to what is necessary in the context of your employment.

Such information includes:
•personal details (name, contact details, date and place of birth, nationality, gender, marital status, family members, bank account information, social security number);
•employment information (also embedded in the employment contract: employment date, job description, function/title, reporting);
•compensation (salary, bonus, equity, benefits, holidays);
•recruitment process (application documents, CV, compensation history, employment agreement);
•business expense reports;
•performance appraisals/ratings;
•holidays and sickness leave, and any other personal data strictly required by applicable laws and regulations.

The Company collects and holds personal information relating to you for the purposes of:
•the justification, implementation and termination of the employment agreement, both during and after your employment with the Company, including salary and benefits administration;
•compliance with laws and regulations, including labour, social security and health laws; and;
•the Company’s legitimate interests, including employee management and administration generally (both during and after your employment), evaluating performances, administrating and monitoring compliance with internal policies, conducting disciplinary investigations and proceedings, and maintaining and monitoring usage of internal networks and IT systems.

You should be aware that in certain instances the Company may need to transfer or disclose your personal information to third parties, including third party service providers. Common examples of third party service providers are payroll processors, IT companies, and companies that provide technical or administrative support. Other third parties may include other Insmed entities, regulatory authorities (including tax authorities) and government agencies, banks and insurance companies, and, potentially, third parties with whom the Company may merge or which may be acquired by the Company. These third parties and Insmed entities may be located in countries, such as the United States (for instance Insmed Incorporated), whose data protection laws may not be equivalent to those applicable in your own country. The Company, however, put in place contractual guarantees to ensure an appropriate level of protection. For more information and a copy, please contact: privacy@insmed.com.



Subject to limitation in the law, you have certain rights in respect of your personal information, such as a right of access, correction, restriction, opposition and deletion. Your personal information will be retained as long as required, in compliance with company policy and retention obligations imposed by law.

Should you have any questions or concerns in connection with the Company’s handling of your personal information, your first point of contact is: Mariela Pochon, Director Human resources EMEA or Hortense de Lummen, Legal Counsel EMEA.

16

Legal is your first point of contact regarding data privacy topics.

Also, at Insmed, an external Data Protection Officer (DPO) is appointed. This means that if our first point of contact (as indicated above) is not suitable in your case, you can directly contact our DPO:

Dr. Oliver Meyer-van Raay
Tel.: +49 721 / 17029034
E-Mail: om@v-formation.gmbh

DPO’s address details are:
V-Formation GmbH
Stephanienstrasse 18
76133 Karlsruhe, Germany

Requests concerning the handling of your employee data will be treated by DPO on a confidential basis if so requested.

If you still have concerns, you have a right to lodge a complaint with the Supervisory Authority for data protection in your country.

17





PERSONAL DATA PROCESSING- EMPLOYEE NOTICE (UNITED KINGDOM ONLY)
As your employer, Insmed Ltd, with registered office in London (the “Company”) collects, uses and discloses personal information relating to you. The Company is committed to ensure that your personal information will be handled in accordance with all applicable data protection laws.

The information that the Company holds on you, collected in both paper and electronic format, is limited to what is necessary in the context of your employment.

Such information includes:
•personal details (name, contact details, date and place of birth, nationality, gender, marital status, family members, bank account information, social security number);
•employment information (also embedded in the employment contract: employment date, job description, function/title, reporting);
•compensation (salary, bonus, equity, benefits, holidays);
•recruitment process (application documents, CV, compensation history, employment agreement);
•business expense reports;
•performance appraisals/ratings;
•holidays and sickness leave, and any other personal data strictly required by applicable laws and regulations.

The Company collects and holds personal information relating to you for the purposes of:
•the justification, implementation and termination of the employment agreement, both during and after your employment with the Company, including salary and benefits administration;
•compliance with laws and regulations, including labour, social security and health laws; and;
•the Company’s legitimate interests, including employee management and administration generally (both during and after your employment), evaluating performances, administrating and monitoring compliance with internal policies, conducting disciplinary investigations and proceedings, and maintaining and monitoring usage of internal networks and IT systems.

You should be aware that in certain instances the Company may need to transfer or disclose your personal information to third parties, including third party service providers. Common examples of third party service providers are payroll processors, IT companies, and companies that provide technical or administrative support. Other third parties may include other Insmed entities, regulatory authorities (including tax authorities) and government agencies, banks and insurance companies, and, potentially, third parties with whom the Company may merge or which may be acquired by the Company. These third parties and Insmed entities may be located in countries, such as the United States (for instance Insmed Incorporated), whose data protection laws may not be equivalent to those applicable in your own country. The Company, however, put in place contractual guarantees to ensure an appropriate level of protection. For more information and a copy, please contact: privacy@insmed.com.


18

Subject to limitation in the law, you have certain rights in respect of your personal information, such as a right of access, correction, restriction, opposition and deletion. Your personal information will be retained as long as required, in compliance with company policy and retention obligations imposed by law. Should you have any questions or concerns in connection with the Company’s handling of your personal information, please consult with Johannes Diependaal, Senior Director EU Operations or Christel Rössig, Senior Director Corporate Counsel & Compliance EU. If you still have concerns, you have a right to lodge a complaint with the Supervisory Authority for data protection in your country.







19

EXHIBIT 31.1
 
Section 302 Certification
 
I, William H. Lewis, Chief Executive Officer of Insmed Incorporated, certify that:

(1) I have reviewed this quarterly report on Form 10-Q of Insmed Incorporated;

(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

(4) The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;

(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

(5) The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date:  May 4, 2023

 
 
/s/ William H. Lewis
William H. Lewis
Chair and Chief Executive Officer
(Principal Executive Officer)
 

EXHIBIT 31.2
 
Section 302 Certification
 
I, Sara Bonstein, Chief Financial Officer of Insmed Incorporated, certify that:

(1) I have reviewed this quarterly report on Form 10-Q of Insmed Incorporated;

(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

(4) The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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;

(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

(5) The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date:  May 4, 2023
 
/s/ Sara Bonstein
Sara Bonstein
Chief Financial Officer
(Principal Financial and Accounting Officer)
 

EXHIBIT 32.1
 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2003
 
In connection with this Quarterly Report on Form 10-Q of Insmed Incorporated (the "Company") for the period ended March 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, William H. Lewis, Chief Executive Officer of the Company, certify, pursuant to 18 USC. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2003, that:
 
(1)the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
/s/ William H. Lewis
William H. Lewis
Chairman and Chief Executive Officer
(Principal Executive Officer)

May 4, 2023
 
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Insmed Incorporated under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

EXHIBIT 32.2
 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2003
 
In connection with this Quarterly Report on Form 10-Q of Insmed Incorporated (the "Company") for the period ended March 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, Sara Bonstein, Chief Financial Officer of the Company, certify, pursuant to 18 USC. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2003, that:

(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
/s/ Sara Bonstein
Sara Bonstein
Chief Financial Officer
(Principal Financial and Accounting Officer)

May 4, 2023
 
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Insmed Incorporated under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.