amag-20200930
000079297712/312020Q3FALSEus-gaap:ProductMemberus-gaap:ProductMemberus-gaap:ProductMemberus-gaap:ProductMember0.33P1Y0.330.036546400007929772020-01-012020-09-30xbrli:shares00007929772020-11-04iso4217:USD00007929772020-09-3000007929772019-12-31iso4217:USDxbrli:shares0000792977us-gaap:ProductMember2020-07-012020-09-300000792977us-gaap:ProductMember2019-07-012019-09-300000792977us-gaap:ProductMember2020-01-012020-09-300000792977us-gaap:ProductMember2019-01-012019-09-300000792977us-gaap:LicenseAndServiceMember2020-07-012020-09-300000792977us-gaap:LicenseAndServiceMember2019-07-012019-09-300000792977us-gaap:LicenseAndServiceMember2020-01-012020-09-300000792977us-gaap:LicenseAndServiceMember2019-01-012019-09-300000792977us-gaap:ProductAndServiceOtherMember2020-07-012020-09-300000792977us-gaap:ProductAndServiceOtherMember2019-07-012019-09-300000792977us-gaap:ProductAndServiceOtherMember2020-01-012020-09-300000792977us-gaap:ProductAndServiceOtherMember2019-01-012019-09-3000007929772020-07-012020-09-3000007929772019-07-012019-09-3000007929772019-01-012019-09-300000792977us-gaap:CommonStockMember2020-06-300000792977us-gaap:AdditionalPaidInCapitalMember2020-06-300000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-06-300000792977us-gaap:RetainedEarningsMember2020-06-3000007929772020-06-300000792977us-gaap:CommonStockMember2020-07-012020-09-300000792977us-gaap:AdditionalPaidInCapitalMember2020-07-012020-09-300000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-07-012020-09-300000792977us-gaap:RetainedEarningsMember2020-07-012020-09-300000792977us-gaap:CommonStockMember2020-09-300000792977us-gaap:AdditionalPaidInCapitalMember2020-09-300000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-09-300000792977us-gaap:RetainedEarningsMember2020-09-300000792977us-gaap:CommonStockMember2019-12-310000792977us-gaap:AdditionalPaidInCapitalMember2019-12-310000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2019-12-310000792977us-gaap:RetainedEarningsMember2019-12-310000792977us-gaap:CommonStockMember2020-01-012020-09-300000792977us-gaap:AdditionalPaidInCapitalMember2020-01-012020-09-300000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-01-012020-09-300000792977us-gaap:RetainedEarningsMember2020-01-012020-09-300000792977us-gaap:CommonStockMember2019-06-300000792977us-gaap:AdditionalPaidInCapitalMember2019-06-300000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2019-06-300000792977us-gaap:RetainedEarningsMember2019-06-3000007929772019-06-300000792977us-gaap:CommonStockMember2019-07-012019-09-300000792977us-gaap:AdditionalPaidInCapitalMember2019-07-012019-09-300000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2019-07-012019-09-300000792977us-gaap:RetainedEarningsMember2019-07-012019-09-300000792977us-gaap:CommonStockMember2019-09-300000792977us-gaap:AdditionalPaidInCapitalMember2019-09-300000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2019-09-300000792977us-gaap:RetainedEarningsMember2019-09-3000007929772019-09-300000792977us-gaap:CommonStockMember2018-12-310000792977us-gaap:AdditionalPaidInCapitalMember2018-12-310000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2018-12-310000792977us-gaap:RetainedEarningsMember2018-12-3100007929772018-12-310000792977us-gaap:CommonStockMember2019-01-012019-09-300000792977us-gaap:AdditionalPaidInCapitalMember2019-01-012019-09-300000792977us-gaap:AccumulatedOtherComprehensiveIncomeMember2019-01-012019-09-300000792977us-gaap:RetainedEarningsMember2019-01-012019-09-300000792977us-gaap:SubsequentEventMemberamag:CovisGroupSRlMemberamag:AMAGPharmaceuticalsIncMember2020-10-010000792977us-gaap:SubsequentEventMemberamag:CovisGroupSRlMemberamag:AMAGPharmaceuticalsIncMember2020-10-012020-10-01xbrli:pure0000792977amag:McKessonCorporationMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2020-07-012020-09-300000792977amag:McKessonCorporationMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2019-07-012019-09-300000792977amag:McKessonCorporationMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2020-01-012020-09-300000792977amag:McKessonCorporationMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2019-01-012019-09-300000792977amag:AmerisourceBergenDrugCorporationMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2020-07-012020-09-300000792977amag:AmerisourceBergenDrugCorporationMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2019-07-012019-09-300000792977amag:AmerisourceBergenDrugCorporationMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2020-01-012020-09-300000792977amag:AmerisourceBergenDrugCorporationMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2019-01-012019-09-300000792977amag:CardinalHealthInc.Memberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2020-07-012020-09-300000792977amag:CardinalHealthInc.Memberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2019-07-012019-09-300000792977amag:CardinalHealthInc.Memberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2020-01-012020-09-300000792977amag:CardinalHealthInc.Memberus-gaap:CustomerConcentrationRiskMemberus-gaap:RevenueFromContractWithCustomerMember2019-01-012019-09-300000792977us-gaap:AccountsReceivableMemberamag:TwoCustomersMemberus-gaap:CustomerConcentrationRiskMember2020-01-012020-09-300000792977us-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMemberamag:ThreeCustomersMember2019-01-012019-12-31amag:facility0000792977amag:FerahemeMember2020-01-012020-09-300000792977amag:FerahemeMember2020-07-012020-09-300000792977amag:FerahemeMember2019-07-012019-09-300000792977amag:FerahemeMember2019-01-012019-09-300000792977amag:MakenaMember2020-07-012020-09-300000792977amag:MakenaMember2019-07-012019-09-300000792977amag:MakenaMember2020-01-012020-09-300000792977amag:MakenaMember2019-01-012019-09-300000792977amag:IntrarosaMember2020-07-012020-09-300000792977amag:IntrarosaMember2019-07-012019-09-300000792977amag:IntrarosaMember2020-01-012020-09-300000792977amag:IntrarosaMember2019-01-012019-09-300000792977amag:ProductOtherMember2020-07-012020-09-300000792977amag:ProductOtherMember2019-07-012019-09-300000792977amag:ProductOtherMember2020-01-012020-09-300000792977amag:ProductOtherMember2019-01-012019-09-3000007929772020-01-012020-03-3100007929772020-03-3100007929772020-04-012020-06-300000792977amag:NorgineBVMemberamag:CiraparantagMember2020-07-012020-07-310000792977amag:NorgineBVMemberamag:CiraparantagMembersrt:MaximumMemberamag:RegulatoryMilestoneAchievementMember2020-07-012020-07-310000792977amag:NorgineBVMemberamag:CiraparantagMember2020-07-310000792977amag:NorgineBVMemberamag:CiraparantagMembersrt:MaximumMemberamag:SalesMilestonesAchievementMember2020-07-012020-07-310000792977amag:NorgineBVMemberamag:LicenseRightsMemberus-gaap:ValuationTechniqueDiscountedCashFlowMemberus-gaap:MeasurementInputDiscountRateMember2020-07-310000792977amag:NorgineBVMemberamag:LicenseRightsMember2020-07-012020-07-310000792977amag:NorgineBVMemberamag:ResearchAndDevelopmentServicesMember2020-07-310000792977amag:NorgineBVMemberamag:DevelopmentServicesMember2020-09-300000792977amag:NorgineBVMemberamag:CiraparantagMember2020-09-300000792977amag:NorgineBVMemberamag:CiraparantagMember2020-01-012020-09-300000792977us-gaap:CorporateDebtSecuritiesMember2020-09-300000792977us-gaap:CertificatesOfDepositMember2020-09-300000792977us-gaap:CommercialPaperNotIncludedWithCashAndCashEquivalentsMember2020-09-300000792977us-gaap:USTreasuryAndGovernmentMember2020-09-300000792977us-gaap:CorporateDebtSecuritiesMember2019-12-310000792977us-gaap:USTreasuryAndGovernmentMember2019-12-310000792977us-gaap:CertificatesOfDepositMember2019-12-310000792977us-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:FairValueMeasurementsRecurringMemberus-gaap:FairValueInputsLevel1Member2020-09-300000792977us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:FairValueInputsLevel1Member2020-09-300000792977us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryAndGovernmentMember2020-09-300000792977us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryAndGovernmentMemberus-gaap:FairValueInputsLevel1Member2020-09-300000792977us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryAndGovernmentMember2020-09-300000792977us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryAndGovernmentMember2020-09-300000792977us-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:FairValueInputsLevel1Member2020-09-300000792977us-gaap:FairValueInputsLevel2Memberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:CertificatesOfDepositMemberus-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:FairValueInputsLevel1Member2020-09-300000792977us-gaap:FairValueInputsLevel2Memberus-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:CommercialPaperMemberus-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2020-09-300000792977us-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977us-gaap:FairValueMeasurementsRecurringMemberus-gaap:FairValueInputsLevel1Member2019-12-310000792977us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:FairValueInputsLevel1Member2019-12-310000792977us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryAndGovernmentMember2019-12-310000792977us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryAndGovernmentMemberus-gaap:FairValueInputsLevel1Member2019-12-310000792977us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryAndGovernmentMember2019-12-310000792977us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryAndGovernmentMember2019-12-310000792977us-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977us-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:FairValueInputsLevel1Member2019-12-310000792977us-gaap:FairValueInputsLevel2Memberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977us-gaap:CertificatesOfDepositMemberus-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977amag:MugardMemberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977amag:MugardMemberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:FairValueInputsLevel1Member2019-12-310000792977amag:MugardMemberus-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977amag:MugardMemberus-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2019-12-310000792977amag:SeniorConvertibleNotesDue2022Memberus-gaap:FairValueInputsLevel2Member2020-09-300000792977amag:ComputerEquipmentAndSoftwareMember2020-09-300000792977amag:ComputerEquipmentAndSoftwareMember2019-12-310000792977us-gaap:FurnitureAndFixturesMember2020-09-300000792977us-gaap:FurnitureAndFixturesMember2019-12-310000792977us-gaap:LeaseholdImprovementsMember2020-09-300000792977us-gaap:LeaseholdImprovementsMember2019-12-310000792977us-gaap:EquipmentMember2020-09-300000792977us-gaap:EquipmentMember2019-12-310000792977us-gaap:ConstructionInProgressMember2020-09-300000792977us-gaap:ConstructionInProgressMember2019-12-310000792977us-gaap:DevelopedTechnologyRightsMemberamag:MakenaAutoInjectorMember2020-09-300000792977us-gaap:DevelopedTechnologyRightsMemberamag:MakenaAutoInjectorMember2019-12-310000792977us-gaap:DevelopedTechnologyRightsMemberamag:IntrarosaMember2020-09-300000792977us-gaap:DevelopedTechnologyRightsMemberamag:IntrarosaMember2019-12-310000792977us-gaap:DevelopedTechnologyRightsMemberamag:VyleesiProductsMember2020-09-300000792977us-gaap:DevelopedTechnologyRightsMemberamag:VyleesiProductsMember2019-12-310000792977us-gaap:EmployeeStockOptionMember2020-01-012020-09-300000792977us-gaap:EmployeeStockOptionMember2019-01-012019-09-300000792977us-gaap:RestrictedStockUnitsRSUMember2020-01-012020-09-300000792977us-gaap:RestrictedStockUnitsRSUMember2019-01-012019-09-300000792977us-gaap:ConvertibleDebtSecuritiesMember2020-01-012020-09-300000792977us-gaap:ConvertibleDebtSecuritiesMember2019-01-012019-09-30amag:planamag:installment0000792977amag:InducementGrantsMember2020-01-012020-09-300000792977amag:EquityIncentivePlan2019Member2019-12-310000792977amag:EquityIncentivePlan2007Member2019-12-310000792977amag:LumaraHealth2013PlanMember2019-12-310000792977amag:InducementGrantsMember2019-12-310000792977amag:EquityIncentivePlan2019Member2020-01-012020-09-300000792977amag:EquityIncentivePlan2007Member2020-01-012020-09-300000792977amag:LumaraHealth2013PlanMember2020-01-012020-09-300000792977amag:EquityIncentivePlan2019Member2020-09-300000792977amag:EquityIncentivePlan2007Member2020-09-300000792977amag:LumaraHealth2013PlanMember2020-09-300000792977amag:InducementGrantsMember2020-09-300000792977us-gaap:RestrictedStockUnitsRSUMemberamag:EquityIncentivePlan2019Member2019-12-310000792977us-gaap:RestrictedStockUnitsRSUMemberamag:EquityIncentivePlan2007Member2019-12-310000792977amag:LumaraHealth2013PlanMemberus-gaap:RestrictedStockUnitsRSUMember2019-12-310000792977us-gaap:RestrictedStockUnitsRSUMemberamag:InducementGrantsMember2019-12-310000792977us-gaap:RestrictedStockUnitsRSUMember2019-12-310000792977us-gaap:RestrictedStockUnitsRSUMemberamag:EquityIncentivePlan2019Member2020-01-012020-09-300000792977us-gaap:RestrictedStockUnitsRSUMemberamag:EquityIncentivePlan2007Member2020-01-012020-09-300000792977amag:LumaraHealth2013PlanMemberus-gaap:RestrictedStockUnitsRSUMember2020-01-012020-09-300000792977us-gaap:RestrictedStockUnitsRSUMemberamag:InducementGrantsMember2020-01-012020-09-300000792977us-gaap:RestrictedStockUnitsRSUMember2020-01-012020-09-300000792977us-gaap:RestrictedStockUnitsRSUMemberamag:EquityIncentivePlan2019Member2020-09-300000792977us-gaap:RestrictedStockUnitsRSUMemberamag:EquityIncentivePlan2007Member2020-09-300000792977amag:LumaraHealth2013PlanMemberus-gaap:RestrictedStockUnitsRSUMember2020-09-300000792977us-gaap:RestrictedStockUnitsRSUMemberamag:InducementGrantsMember2020-09-300000792977us-gaap:RestrictedStockUnitsRSUMember2020-09-300000792977us-gaap:CostOfSalesMember2020-07-012020-09-300000792977us-gaap:CostOfSalesMember2019-07-012019-09-300000792977us-gaap:CostOfSalesMember2020-01-012020-09-300000792977us-gaap:CostOfSalesMember2019-01-012019-09-300000792977us-gaap:ResearchAndDevelopmentExpenseMember2020-07-012020-09-300000792977us-gaap:ResearchAndDevelopmentExpenseMember2019-07-012019-09-300000792977us-gaap:ResearchAndDevelopmentExpenseMember2020-01-012020-09-300000792977us-gaap:ResearchAndDevelopmentExpenseMember2019-01-012019-09-300000792977us-gaap:SellingGeneralAndAdministrativeExpensesMember2020-07-012020-09-300000792977us-gaap:SellingGeneralAndAdministrativeExpensesMember2019-07-012019-09-300000792977us-gaap:SellingGeneralAndAdministrativeExpensesMember2020-01-012020-09-300000792977us-gaap:SellingGeneralAndAdministrativeExpensesMember2019-01-012019-09-300000792977us-gaap:RestructuringChargesMember2019-01-012019-09-3000007929772020-01-0100007929772019-03-310000792977srt:MinimumMember2020-09-300000792977srt:MaximumMember2020-09-30amag:defendant0000792977amag:CivilCaseInSaginawChippewaIndianTribeVPurduePharmaEtAlMemberus-gaap:PendingLitigationMember2019-11-062019-11-0600007929772019-09-252019-09-250000792977amag:PerospherePharmaceuticalsInc.Member2019-01-160000792977amag:PerospherePharmaceuticalsInc.Memberamag:RegulatoryMilestoneAchievementMember2019-01-160000792977amag:PerospherePharmaceuticalsInc.Memberamag:MilestoneAchievementApprovalByEuropeanMedicinesAgencyMember2019-01-160000792977amag:PerospherePharmaceuticalsInc.Memberamag:SalesMilestonesAchievementMember2019-01-160000792977amag:PerospherePharmaceuticalsInc.Memberamag:FirstSalesMilestoneAchievementMember2019-01-162019-01-160000792977amag:RegulatoryMilestoneAchievementU.S.FoodAndDrugAdministrationApprovalMemberamag:VeloBioLLCMember2018-09-300000792977amag:AnnualSalesMilestoneAchievementsMemberamag:VeloBioLLCMember2018-09-300000792977amag:AnnualSalesMilestoneAchievementsMembersrt:MinimumMemberamag:VeloBioLLCMember2018-09-012018-09-300000792977amag:AnnualSalesMilestoneAchievementsMembersrt:MaximumMemberamag:VeloBioLLCMember2018-09-012018-09-300000792977amag:RegulatoryMilestoneAchievementMemberamag:VeloBioLLCMember2018-09-300000792977amag:CommercialMilestonePaymentsMemberamag:VeloBioLLCMember2018-09-3000007929772020-08-062020-08-060000792977amag:IntrarosaMemberamag:MillicentPharmaLimitedMember2020-05-212020-05-210000792977srt:MaximumMemberamag:IntrarosaMemberamag:MillicentPharmaLimitedMember2020-05-212020-05-210000792977amag:FirstTimeNetSalesDuringThresholdPeriodExceeds65MillionMemberamag:IntrarosaMemberamag:MillicentPharmaLimitedMember2020-05-212020-05-21amag:day0000792977amag:FirstTimeNetSalesDuringThresholdPeriodExceeds115MillionMemberamag:IntrarosaMemberamag:MillicentPharmaLimitedMember2020-05-212020-05-210000792977amag:FirstTimeNetSalesDuringThresholdPeriodExceeds175MillionMemberamag:IntrarosaMemberamag:MillicentPharmaLimitedMember2020-05-212020-05-210000792977amag:IntrarosaMemberamag:MillicentPharmaLimitedMember2020-01-012020-09-300000792977amag:IntrarosaMemberamag:MillicentPharmaLimitedMember2020-07-012020-09-300000792977amag:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementTransactionFeesMemberamag:IntrarosaMemberamag:MillicentPharmaLimitedMember2020-01-012020-09-300000792977amag:CollaborativeArrangementTransactionWithPartyToCollaborativeArrangementCarryingValueOfAssetsSoldAndOtherCostsMemberamag:IntrarosaMemberamag:MillicentPharmaLimitedMember2020-01-012020-09-300000792977amag:VyleesiProductsMemberamag:PalatinTechnologiesInc.Member2020-07-012020-07-310000792977srt:ScenarioForecastMemberus-gaap:SubsequentEventMemberamag:VyleesiProductsMemberamag:PalatinTechnologiesInc.Member2021-03-312021-03-310000792977amag:VyleesiProductsMemberamag:PalatinTechnologiesInc.Member2020-01-012020-09-300000792977amag:VyleesiProductsMemberamag:PalatinTechnologiesInc.Member2020-07-012020-09-300000792977amag:ConvertibleNotesDue2022Memberus-gaap:ConvertibleDebtMember2020-09-300000792977amag:ConvertibleNotesDue2022Memberus-gaap:ConvertibleDebtMember2019-12-310000792977amag:ConvertibleNotesDue2022Memberus-gaap:ConvertibleDebtMember2020-01-012020-09-300000792977amag:ConvertibleNotesDue2022Memberus-gaap:ConvertibleDebtMember2017-06-300000792977amag:ConvertibleNotesDue2022Memberus-gaap:ConvertibleDebtMember2017-04-012017-06-300000792977amag:ConvertibleNotesDue2022Memberamag:DebtInstrumentConversionPeriodOneMemberus-gaap:ConvertibleDebtMember2017-04-012017-06-300000792977amag:ConvertibleNotesDue2022Memberamag:DebtInstrumentConversionPeriodTwoMemberus-gaap:ConvertibleDebtMember2017-04-012017-06-300000792977amag:ConvertibleNotesDue2019Memberus-gaap:ConvertibleDebtMember2014-02-280000792977amag:ConvertibleNotesDue2019Memberus-gaap:ConvertibleDebtMember2017-12-310000792977amag:ConvertibleNotesDue2019Memberus-gaap:ConvertibleDebtMember2019-02-152019-02-150000792977us-gaap:ConvertibleDebtMember2020-07-012020-09-300000792977us-gaap:ConvertibleDebtMember2019-07-012019-09-300000792977us-gaap:ConvertibleDebtMember2020-01-012020-09-300000792977us-gaap:ConvertibleDebtMember2019-01-012019-09-30amag:employee00007929772020-05-012020-05-3000007929772019-02-012019-02-2800007929772019-01-012019-03-310000792977amag:RestructuringPlan2019Member2019-12-310000792977amag:RestructuringPlan2020Member2019-12-310000792977amag:RestructuringPlan2019Member2020-01-012020-09-300000792977amag:RestructuringPlan2020Member2020-01-012020-09-300000792977amag:RestructuringPlan2019Memberus-gaap:EmployeeSeveranceMember2020-01-012020-09-300000792977amag:RestructuringPlan2020Memberus-gaap:EmployeeSeveranceMember2020-01-012020-09-300000792977us-gaap:EmployeeSeveranceMember2020-01-012020-09-300000792977us-gaap:OtherRestructuringMemberamag:RestructuringPlan2019Member2020-01-012020-09-300000792977us-gaap:OtherRestructuringMemberamag:RestructuringPlan2020Member2020-01-012020-09-300000792977us-gaap:OtherRestructuringMember2020-01-012020-09-300000792977amag:RestructuringPlan2019Member2020-09-300000792977amag:RestructuringPlan2020Member2020-09-300000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMember2020-07-010000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMemberamag:RevisionPeriodTwoMember2020-01-012020-03-310000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMember2020-04-012020-06-300000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMember2020-01-012020-03-310000792977srt:ScenarioPreviouslyReportedMember2020-06-300000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMember2020-06-300000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMember2016-01-012020-03-310000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMember2016-01-012019-12-310000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMemberamag:RevisionPeriodOneMember2020-01-012020-03-310000792977us-gaap:ProductMembersrt:ScenarioPreviouslyReportedMember2019-07-012019-09-300000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMemberus-gaap:ProductMember2019-07-012019-09-300000792977us-gaap:ProductMembersrt:ScenarioPreviouslyReportedMember2019-01-012019-09-300000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMemberus-gaap:ProductMember2019-01-012019-09-300000792977srt:ScenarioPreviouslyReportedMember2019-07-012019-09-300000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMember2019-07-012019-09-300000792977srt:ScenarioPreviouslyReportedMember2019-01-012019-09-300000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMember2019-01-012019-09-300000792977srt:RevisionOfPriorPeriodErrorCorrectionAdjustmentMember2019-01-010000792977amag:CovisGroupSRlMemberus-gaap:SubsequentEventMember2020-10-012020-10-01amag:claim0000792977us-gaap:SubsequentEventMemberus-gaap:PendingLitigationMemberamag:SecuritiesLitigationMember2020-10-012020-10-01





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 September 30, 2020
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 001-10865
AMAG Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware04-2742593
(State or Other Jurisdiction of
Incorporation or Organization)
(I.R.S. Employer
Identification No.)
1100 Winter Street,Waltham,Massachusetts02451
(Address of Principal Executive Offices)(Zip Code)
(617498-3300
(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.01 per share
AMAGNASDAQ 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   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   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 definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Accelerated filer
Non-accelerated filer
Smaller reporting company
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes   No 
As of November 4, 2020, there were 34,725,063 shares of the registrant’s Common Stock, par value $0.01 per share, outstanding.


Table of Contents
AMAG PHARMACEUTICALS, INC.
FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2020
TABLE OF CONTENTS
 
 
 
 
 
  
  
 

2



Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements:
3



Table of Contents
AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
(Unaudited)
 September 30, 2020December 31, 2019
ASSETS
Current assets:  
Cash and cash equivalents$97,984 $113,009 
Marketable securities70,917 58,742 
Accounts receivable, net67,608 94,163 
Inventories22,906 31,553 
Prepaid and other current assets23,959 19,100 
Total current assets283,374 316,567 
Property and equipment, net2,415 4,116 
Goodwill422,513 422,513 
Intangible assets, net1,973 23,620 
Operating lease right-of-use asset21,063 23,286 
Deferred tax assets 630 
Restricted cash495 495 
Other long-term assets2,523  
Total assets$734,356 $791,227 
LIABILITIES AND STOCKHOLDERS’ EQUITY  
Current liabilities:  
Accounts payable$9,742 $27,021 
Accrued expenses146,597 183,382 
Current portion of deferred revenue2,477  
Current portion of operating lease liability3,161 4,077 
Current portion of acquisition-related contingent consideration 17 
Total current liabilities161,977 214,497 
Long-term liabilities:  
Convertible notes, net
289,334 277,034 
Long-term operating lease liability18,726 19,791 
Long-term deferred revenue7,662  
Other long-term liabilities635 89 
Total liabilities478,334 511,411 
Commitments and contingencies (Note N)
Stockholders’ equity:  
Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued
  
Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,503,435 and 33,999,081 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively
345 339 
Additional paid-in capital1,305,412 1,297,917 
Accumulated other comprehensive loss(3,068)(3,239)
Accumulated deficit(1,046,667)(1,015,201)
Total stockholders’ equity256,022 279,816 
Total liabilities and stockholders’ equity$734,356 $791,227 
The accompanying notes are an integral part of these condensed consolidated financial statements.
4



Table of Contents
AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(Unaudited)
 
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Revenues:
Product sales, net$73,229 $83,784 $190,702 $236,831 
Collaboration revenue19,838  19,838  
Other revenues39 24 97 231 
Total revenues93,106 83,808 210,637 237,062 
Costs and expenses:    
Cost of product sales13,340 21,105 55,426 63,871 
Research and development expenses7,115 15,330 26,558 48,377 
Acquired in-process research and development   74,856 
Selling, general and administrative expenses35,656 65,720 127,922 217,727 
Impairment of intangible assets   77,358 
Loss on disposal of assets, net35,400  20,956  
Restructuring expenses  8,197 7,420 
Total costs and expenses91,511 102,155 239,059 489,609 
Operating income (loss) 1,595 (18,347)(28,422)(252,547)
Other income (expense):    
Interest expense(6,798)(6,419)(20,101)(19,199)
Interest and dividend income246 840 1,050 3,650 
Other income14,606 218 15,894 561 
Total other income (expense), net8,054 (5,361)(3,157)(14,988)
Income (loss) before income taxes9,649 (23,708)(31,579)(267,535)
Income tax (benefit) expense(53)232 (113)(26)
Net income (loss)$9,702 $(23,940)$(31,466)$(267,509)
Net income (loss) per share:
Basic$0.28 $(0.71)$(0.92)$(7.85)
Diluted$0.28 $(0.71)$(0.92)$(7.85)
Weighted average shares outstanding used to compute net income (loss) per share:
Basic34,484 33,906 34,314 34,058 
Diluted34,720 33,906 34,314 34,058 

The accompanying notes are an integral part of these condensed consolidated financial statements.
5



Table of Contents
AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(IN THOUSANDS)
(Unaudited)

 Three Months Ended September 30,Nine Months Ended September 30,
 2020201920202019
Net income (loss)$9,702 $(23,940)$(31,466)$(267,509)
Other comprehensive loss:    
Unrealized (losses) gains on securities, net of tax(104)(167)171 786 
Total comprehensive income (loss)$9,598 $(24,107)$(31,295)$(266,723)

The accompanying notes are an integral part of these condensed consolidated financial statements.
6



Table of Contents
AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT SHARES)
(Unaudited)



Common Stock
SharesAmountAdditional Paid-in CapitalAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
Balance at July 1, 202034,463,373 $344 $1,303,095 $(2,964)$(1,056,369)$244,106 
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings40,062 1 94 — — 95 
Non-cash equity based compensation— — 2,223 — — 2,223 
Unrealized losses on securities, net of tax— — — (104)— (104)
Net income— — — — 9,702 9,702 
Balance at September 30, 202034,503,435 $345 $1,305,412 $(3,068)$(1,046,667)$256,022 





Common Stock    
SharesAmountAdditional Paid-in CapitalAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
Balance at January 1, 202033,999,081 $339 $1,297,917 $(3,239)$(1,015,201)$279,816 
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings408,152 5 (1,237)— — (1,232)
Issuance of common stock under employee stock purchase plan96,202 1 630 — — 631 
Non-cash equity based compensation— — 8,102 — — 8,102 
Unrealized gains on securities, net of tax— — — 171 — 171 
Net loss— — — — (31,466)(31,466)
Balance at September 30, 202034,503,435 $345 $1,305,412 $(3,068)$(1,046,667)$256,022 

The accompanying notes are an integral part of these condensed consolidated financial statements.

















7



Table of Contents
AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT SHARES)
(Unaudited)



Common Stock
SharesAmountAdditional Paid-in CapitalAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
Balance at July 1, 201933,899,954 $339 $1,287,553 $(3,032)$(791,109)$493,751 
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings15,555 — (69)— — (69)
Non-cash equity based compensation— — 4,974 — — 4,974 
Unrealized losses on securities, net of tax— — — (167)(167)
Net loss— — — — (23,940)(23,940)
Balance at September 30, 201933,915,509 $339 $1,292,458 $(3,199)$(815,049)$474,549 




Common Stock    
SharesAmountAdditional Paid-in CapitalAccumulated Other Comprehensive LossAccumulated DeficitTotal Stockholders' Equity
Balance at January 1, 201934,606,760 $346 $1,292,736 $(3,985)$(547,540)$741,557 
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings278,474 3 (1,790)— — (1,787)
Issuance of common stock under employee stock purchase plan105,075 1 850 — — 851 
Repurchase of common stock pursuant to the share repurchase program(1,074,800)(11)(13,719)— — (13,730)
Non-cash equity based compensation— — 14,381 — — 14,381 
Unrealized gains on securities, net of tax— — — 786 — 786 
Net loss— — — — (267,509)(267,509)
Balance at September 30, 201933,915,509 $339 $1,292,458 $(3,199)$(815,049)$474,549 

The accompanying notes are an integral part of these condensed consolidated financial statements.

8



Table of Contents
AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(Unaudited)
Nine Months Ended September 30,
 20202019
Cash flows from operating activities:  
Net loss$(31,466)$(267,509)
Adjustments to reconcile net loss to net cash used in operating activities:  
Depreciation and amortization22,276 13,871 
Impairment of intangible assets 77,358 
Provision for bad debt expense230 (12)
Amortization of premium/discount on purchased securities94 (64)
Write-down of inventory1,916 4,872 
Loss on disposal of property & equipment273  
Non-cash equity-based compensation expense 8,100 14,381 
Non-cash IPR&D expense 18,029 
Amortization of debt discount and debt issuance costs12,300 11,332 
Gains on marketable securities, net(10)(263)
Change in fair value of contingent consideration (16)
Deferred income taxes630 408 
Non-cash lease expense1,416  
Gain on sale of assets7,047  
Changes in operating assets and liabilities: 
Accounts receivable, net26,328 (2,229)
Inventories(676)(6,824)
Prepaid and other current assets(5,797)(24,075)
Accounts payable and accrued expenses(58,258)54,073 
Deferred revenues9,461 (101)
Other assets and liabilities(627)1,038 
Net cash used in operating activities(6,763)(105,731)
Cash flows from investing activities:  
Proceeds from sales or maturities of marketable securities43,675 85,321 
Purchase of marketable securities(55,763)(14,815)
Milestone payment for Vyleesi developed technology (60,000)
Net proceeds from the sale of assets4,920  
Capital expenditures(475)(2,098)
Net cash (used in) provided by investing activities(7,643)8,408 
Cash flows from financing activities:  
Payments to settle convertible notes (21,417)
Payments of contingent consideration(17)(50)
Payments for repurchases of common stock (13,730)
Proceeds from the issuance of common stock under the ESPP630 851 
Proceeds from the exercise of common stock options168 30 
Payments of employee tax withholding related to equity-based compensation(1,400)(1,817)
Net cash used in financing activities(619)(36,133)
Net decrease in cash, cash equivalents, and restricted cash(15,025)(133,456)
Cash, cash equivalents, and restricted cash at beginning of the period113,504 253,751 
Cash, cash equivalents, and restricted cash at end of the period$98,479 $120,295 
Supplemental data for cash flow information:
Cash (refunded) paid for taxes$(254)$456 
Cash paid for interest$5,200 $5,467 
Non-cash investing and financing activities:
Settlement of note receivable in connection with Perosphere acquisition$ $10,000 
Right-of-use assets obtained in exchange for lease liabilities$ $918 
The accompanying notes are an integral part of these condensed consolidated financial statements.
9



Table of Contents
AMAG PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
A.     DESCRIPTION OF BUSINESS
AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. Throughout this Quarterly Report on Form 10-Q, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as “the Company,” “AMAG,” “we,” “us,” or “our.” We are a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs by leveraging our development and commercial expertise to invest in and grow our pharmaceutical products and product candidates across a range of therapeutic areas. As of September 30, 2020, we marketed products that support the health of patients in the areas of hematology and maternal health, including Feraheme® (ferumoxytol injection) for intravenous use and Makena® (hydroxyprogesterone caproate injection) auto-injector. In addition to our approved products, our portfolio includes ciraparantag, a product candidate that is being studied as an anticoagulant reversal agent.

In December 2019, we completed a review of our product portfolio and strategy. This strategic review resulted in our intention to divest our women’s health assets, as announced in January 2020, and as previously disclosed, we completed the divestiture of Intrarosa® (prasterone) during the second quarter of 2020. We completed the divestiture of our remaining women’s health asset, Vyleesi® (bremelanotide injection), in July 2020, which we determined did not meet the criteria for presentation as a discontinued operation, as it did not represent a strategic shift to our business as described above. For additional details on our divestiture of Vyleesi, refer to Note O, “Acquisitions, Collaboration, License and other Strategic Agreements”.

In July 2020, we also decided to stop the AMAG-423 Phase 2b/3a study based, primarily, on the results of an interim analysis conducted by the study’s independent Data Safety Monitoring Board (“DSMB”). For additional details on our decision to stop the AMAG 423 study, refer to Note O, “Acquisitions, Collaboration, License and other Strategic Agreements”.

On October 1, 2020, we entered into an Agreement and Plan of Merger with Covis Group S.à r.l., a Luxembourg company (“Covis”), Covis Mergerco Inc., a Delaware corporation and an indirect wholly owned subsidiary of Covis (“Merger Sub”), and (in respect of specific matters) Covis Finco S.à r.l., a Luxembourg company (the “Merger Agreement”), pursuant to which Merger Sub launched a cash tender offer (the “Offer”) to acquire all of the issued and outstanding shares of common stock of AMAG at a price per share of $13.75, net to the seller in cash, without interest. The Offer commenced on October 15, 2020 and will remain open for a minimum of 20 business days. The completion of the Offer is subject to customary closing conditions. For additional information, see Note T, “Subsequent Events”.

On October 5, 2020, we received notice of the FDA’s Center for Drug Evaluation and Research proposal to withdraw marketing approval of Makena and notice of our opportunity to request a hearing. For additional information, refer to Note T, “Subsequent Events”.

COVID-19
The global spread of COVID-19 has created significant volatility, uncertainty and economic disruption on a global scale, including in the United States, where we market our products, where our operations and employees reside and where we conduct clinical trials. The COVID-19 pandemic did not significantly impact our financial results during the three months ended September 30, 2020. The extent to which the COVID-19 pandemic impacts our business, operations and financial results in the future will depend on numerous evolving factors that we may not be able to accurately predict. While there have been no material impairments to date, any prolonged material disruptions to our sales, supply, research and development efforts and/or operations could negatively impact the Company’s business, operations and/or financial results.

B.     BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments necessary for a fair statement of our financial position and results of operations for the interim periods presented. Such adjustments consisted only of normal recurring items. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”).
In accordance with GAAP for interim financial reports and the instructions for Form 10-Q and the rules of the Securities and Exchange Commission, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. Our accounting policies are described in the Notes to the Consolidated Financial Statements in our
10



Table of Contents
Annual Report on Form 10-K for the year ended December 31, 2019, as amended (our “Annual Report”). Interim results are not necessarily indicative of the results of operations for the full year. These interim financial statements should be read in conjunction with our Annual Report.
Principles of Consolidation
The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates and Assumptions
The preparation of our condensed consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including product sales revenue; product sales allowances and accruals; allowance for expected credit losses; marketable securities; inventory; fair value estimates used to assess impairment of long-lived assets, including goodwill and other intangible assets; debt obligations; certain accrued liabilities, including clinical trial accruals; equity-based compensation expense; and income taxes, inclusive of valuation allowances, will depend on future developments that are highly uncertain, including new information that may emerge concerning COVID-19 and the actions taken to contain or treat its impact, as well as the economic impact on local, regional and national customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results could differ materially from these estimates.
Concentrations and Significant Customer Information
Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. As of September 30, 2020, we held our excess cash primarily in institutional money market funds, corporate debt securities, commercial paper, U.S. treasury and government agency securities and certificates of deposit. As of September 30, 2020, we did not have a material concentration in any single investment.

Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. The following table sets forth customers who represented 10% or more of our total revenues for the three and nine months ended September 30, 2020 and 2019:
Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
McKesson Corporation36 %38 %36 %37 %
AmerisourceBergen Drug Corporation32 %28 %33 %27 %
Cardinal Health12 %11 %11 %12 %
 
Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors and specialty pharmacies. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for expected credit losses. At September 30, 2020, two customers accounted for 10% or more of our accounts receivable balances, representing approximately 76% in the aggregate of our total accounts receivable. At December 31, 2019, three customers accounted for 10% or more of our accounts receivable balances, representing approximately 85% in the aggregate of our total accounts receivable.
We are currently dependent on a single supplier for certain of our manufacturing processes, including for Feraheme drug substance (produced in two separate facilities) and for our Makena auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason.
11



Table of Contents
Recently Adopted Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“Topic 326”). We adopted Topic 326 effective January 1, 2020 using a modified retrospective approach. The adoption of Topic 326 did not have a material impact on our condensed consolidated financial statements and accordingly, no transition adjustment was recorded at the adoption date. Under Topic 326, we estimate expected credit losses for our trade receivables held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. We also evaluate any impaired marketable securities against the new impairment model within Topic 326 to determine whether any loss or allowance for credit loss should be recorded at the reporting date.

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”) as part of its Simplification Initiative to reduce the cost and complexity in accounting for income taxes. ASU 2019-12 removes certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 also amends other aspects of the guidance to help simplify and promote consistent application of GAAP. The guidance is effective for interim and annual periods beginning after December 15, 2020, with early adoption permitted. We adopted ASU 2019-12 effective January 1, 2020. The adoption of ASU 2019-12 did not have a material impact on our condensed consolidated financial statements.

C.     REVENUE RECOGNITION
Product Revenue and Allowances and Accruals

The following table provides information about disaggregated revenue by product for the three and nine months ended September 30, 2020 and 2019 (in thousands):
 Three Months Ended September 30,Nine Months Ended September 30,
2020201920202019
Product sales, net  
Feraheme$46,718 $44,205 $120,786 $126,294 
Makena25,860 33,949 66,079 95,483 
Intrarosa37 5,607 4,423 14,898 
Other614 23 (586)156 
Total product sales, net$73,229 $83,784 $190,702 $236,831 

Total gross product sales were offset by product sales allowances and accruals for the three and nine months ended September 30, 2020 and 2019 as follows (in thousands):
 Three Months Ended September 30,Nine Months Ended September 30,
 2020201920202019
Gross product sales$218,739 $254,073 $633,475 $704,976 
Provision for product sales allowances and accruals:    
Contractual adjustments129,966 144,108 383,003 381,633 
Governmental rebates15,544 26,181 59,770 86,512 
Total145,510 170,289 442,773 468,145 
Product sales, net$73,229 $83,784 $190,702 $236,831 

The following table summarizes the product revenue allowance and accrual activity for the three and nine months ended September 30, 2020 (in thousands):
12



Table of Contents
 ContractualGovernmental 
 AdjustmentsRebatesTotal
Balance at December 31, 2019$95,221 $47,623 $142,844 
Provisions related to current period sales147,235 20,982 168,217 
Adjustments related to prior period sales(4,060)976 (3,084)
Payments/returns relating to current period sales(95,284) (95,284)
Payments/returns relating to prior period sales(37,969)(29,646)(67,615)
Balance at March 31, 2020$105,143 $39,935 $145,078 
Provisions related to current period sales111,508 21,904 133,412 
Adjustments related to prior period sales(634)378 (256)
Payments/returns relating to current period sales(112,821)(13,913)(126,734)
Payments/returns relating to prior period sales(19,484)(10,240)(29,724)
Balance at June 30, 2020$83,712 $38,064 $121,776 
Provisions related to current period sales129,402 17,410 146,812 
Adjustments related to prior period sales565 (1,867)(1,302)
Payments/returns relating to current period sales(115,634)(14,259)(129,893)
Payments/returns relating to prior period sales(5,803)(830)(6,633)
Balance at September 30, 2020$92,242 $38,518 $130,760 

Collaboration Revenue

In July 2020, we entered into a License and Commercialization Agreement with Norgine B.V. (“Norgine”, and such agreement, the “Norgine Agreement”), pursuant to which we granted Norgine an exclusive license to develop and commercialize ciraparantag in certain countries in Europe, Australia and New Zealand (the “Norgine Territory”). We received a $30.0 million upfront payment upon signing. In addition, pursuant to the terms and conditions of the Norgine Agreement (a) Norgine will pay us one-third of the actual and reasonable out-of-pocket costs of the Phase 3 program, pursuant to a mutually agreed upon budget, (b) we are eligible to receive up to $70.0 million upon the achievement of certain regulatory milestones (of which we will pay $40.0 million to the former equity holders of Perosphere pursuant to the terms of the Perosphere Agreement (described below), (c) we are eligible to receive up to $190.0 million contingent upon meeting certain sales milestones, and (d) Norgine will pay us tiered double-digit royalties on net sales in the licensed territory. Norgine will be responsible for the regulatory filings and any clinical trials specifically required for approval of the Product in the Norgine Territory and will hold all marketing authorizations in the Norgine Territory. We will be responsible for manufacturing and supplying Norgine with its requirements of clinical and commercial product pursuant to supply agreement(s) to be entered into by the parties.

In accordance with ASC 808, we considered the nature and contractual terms of the arrangement and the nature of our business operations to determine the classification of payments under the Norgine Agreement and concluded that Norgine meets the definition of a customer. As a result, the Norgine Agreement was accounted for under ASC 606. We determined that the Norgine Agreement contains three distinct performance obligations: (i) delivery of a license granting rights to clinical data developed to date and rights to develop and commercialize ciraparantag in the Norgine Territory (the “License”), (ii) research and development services, and (iii) participation on the joint development and steering committees.

We allocated the upfront consideration to each performance obligation using the standalone selling prices based on our estimate of selling price for the License, research and development services and participation on the joint development and steering committees. To determine the standalone selling price for the License and for the participation on the joint development and joint steering committees, we used an adjusted market approach. For the License, the adjusted market approach included an assessment of the likelihood of achievement of certain regulatory milestones using third party evidence and the likelihood of regulatory approval of ciraparantag and the expected future cash flows assuming regulatory approval in the Norgine Territory, discounting these cash flows using a risk adjusted discount rate of approximately 27%. For the research and development services we determined the standalone selling pricing using a cost plus margin approach. For the joint development and joint steering committees, the adjusted market approach included an assessment of consulting rates prevalent in the marketplace.

13



Table of Contents
Under Topic 606, we allocated the $30.0 million upfront payment as follows: $19.8 million to the License and $10.2 million to the research and development services. No consideration was allocated to the performance obligation related to participation on the joint development and steering committees, as its standalone selling price was not material. The amounts allocated to the licenses were recognized upon delivery of the licenses during the three months ended September 30, 2020. The amount allocated to the development services will be recognized over the course of the development work using an input method in the form of development effort relative to expected total development effort at the completion of the development services. This is based on the relative costs of the development activities incurred and expected to be incurred in the future to satisfy the performance obligation. The estimated period of performance to satisfy the performance obligation and project cost will be reviewed periodically and adjusted, as needed, to reflect our current expectations regarding the costs and timing of the deliverable. These estimates are subject to a number of assumptions and actual results could differ materially from our assumptions in future periods.

We determined that the future regulatory and sales-based milestone and sales-based royalty payments that we may be entitled to receive are variable consideration. We are using a most likely amount method for estimating the variable consideration to be received related to regulatory milestones under this arrangement. All future potential regulatory milestones were fully constrained at September 30, 2020. The sales-based milestones and royalties are subject to the sales-and-usage-based royalty exception related to a license of intellectual property and will be recorded in the period when the corresponding sale occurs.

As of September 30, 2020, deferred revenue related to the development services performance obligation amounted to $10.2 million, of which $2.5 million was included in current liabilities.

In addition, the Company incurred approximately $2.0 million of contract acquisition costs related to the Norgine Agreement. These costs are expensed as selling, general and administrative expense based on the transfer of control of the underlying performance obligations, as determined on a relative standalone selling price basis. As of September 30, 2020, the Company recorded approximately $1.3 million in selling, general and administrative expense and deferred $0.7 million as a component of other long-term assets.

D.    MARKETABLE SECURITIES

As of September 30, 2020 and December 31, 2019, our marketable securities consisted of securities classified as available-for-sale in accordance with accounting standards which provide guidance related to accounting and classification of certain investments in marketable securities.

14



Table of Contents
The following is a summary of our marketable securities as of September 30, 2020 and December 31, 2019 (in thousands):
September 30, 2020
GrossGrossEstimated
AmortizedUnrealizedUnrealizedFair
CostGainsLossesValue
Securities maturing within one year:
Corporate debt securities$23,861 $145 $(1)$24,005 
Certificates of deposit14,300   14,300 
Commercial paper9,488   9,488 
Total securities maturing within one year$47,649 $145 $(1)$47,793 
Securities maturing between one and three years:
Corporate debt securities$16,809 $319 $(2)$17,126 
U.S. treasury and government agency securities4,998   4,998 
Certificates of deposit1,000   1,000 
Total securities maturing between one and three years$22,807 $319 $(2)$23,124 
Total marketable securities$70,456 $464 $(3)$70,917 


December 31, 2019
GrossGrossEstimated
AmortizedUnrealizedUnrealizedFair
CostGainsLossesValue
Securities maturing within one year:
Corporate debt securities$46,186 $140 $(2)$46,324 
U.S. treasury and government agency securities2,750   2,750 
Certificates of deposit1,500   1,500 
Total securities maturing within one year$50,436 $140 $(2)$50,574 
Securities maturing between one and three years:
Corporate debt securities$8,016 $152 $ $8,168 
Total securities maturing between one and three years8,016 152  8,168 
Total marketable securities$58,452 $292 $(2)$58,742 


E.     FAIR VALUE MEASUREMENTS
The following tables present information about our assets and liabilities that we measure at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques utilized to determine such fair value as of September 30, 2020 and December 31, 2019 (in thousands):
 Fair Value Measurements at September 30, 2020 Using:
  Quoted Prices in Significant
  Active Markets forSignificant OtherUnobservable
  Identical AssetsObservable InputsInputs
 Total(Level 1)(Level 2)(Level 3)
Assets:
Cash equivalents$2,750 $2,750 $ $ 
Corporate debt securities41,131  41,131  
U.S. treasury and government agency securities4,998 4,998  
Certificates of deposit15,300  15,300  
Commercial paper9,488 9,488  
Total assets$73,667 $2,750 $70,917 $ 
15



Table of Contents
 
 Fair Value Measurements at December 31, 2019 Using:
  Quoted Prices in Significant
  Active Markets forSignificant OtherUnobservable
  Identical AssetsObservable InputsInputs
 Total(Level 1)(Level 2)(Level 3)
Assets:    
Cash equivalents$13,732 $13,732 $ $ 
Corporate debt securities54,492  54,492  
U.S. treasury and government agency securities2,750