10-Q – 2025-11-03 – axsm-20250930.htm

Automatiskt nyckeltalsindex

Detta är sökträffar och textkontext, inte verifierade eller normaliserade redovisningsvärden.

Fulltext

Dokumentet är delat för att hålla varje sida lätt att hämta. Del 1 · Del 2 · Del 3

10-Q

0001579428 --12-31 false Q3 http://fasb.org/us-gaap/2025#AccountsPayableAndOtherAccruedLiabilitiesCurrent http://fasb.org/us-gaap/2025#AccountsPayableAndOtherAccruedLiabilitiesCurrent http://fasb.org/us-gaap/2025#SecuredOvernightFinancingRateSofrMember http://fasb.org/us-gaap/2025#SecuredOvernightFinancingRateSofrMember http://fasb.org/us-gaap/2025#PrepaidExpenseAndOtherAssetsCurrent P10D http://fasb.org/srt/2025#ChiefExecutiveOfficerMember 0001579428 us-gaap:ProductMember 2025-01-01 2025-09-30 0001579428 axsm:ContingentConsiderationMember us-gaap:FairValueInputsLevel3Member us-gaap:MeasurementInputRevenueMultipleMember us-gaap:IncomeApproachValuationTechniqueMember srt:MaximumMember 2024-12-31 0001579428 us-gaap:AdditionalPaidInCapitalMember 2024-07-01 2024-09-30 0001579428 axsm:AriMaizelMember 2025-09-30 0001579428 srt:MinimumMember axsm:PerformanceStockUnitsMember 2025-02-01 2025-02-28 0001579428 us-gaap:AdditionalPaidInCapitalMember 2025-04-01 2025-06-30 0001579428 2024-07-01 2024-09-30 0001579428 us-gaap:ProductMember 2024-01-01 2024-09-30 0001579428 axsm:BlackstoneLoanAgreementMember 2025-05-08 0001579428 us-gaap:AdditionalPaidInCapitalMember 2024-06-30 0001579428 us-gaap:CommonStockMember axsm:JuneTwoThousandTwentyThreePublicOfferingMember 2023-06-01 2023-06-30 0001579428 us-gaap:RoyaltyMember 2024-07-01 2024-09-30 0001579428 us-gaap:EmployeeStockOptionMember 2024-01-01 2024-09-30 0001579428 axsm:AXS-12Member 2025-01-01 2025-09-30 0001579428 us-gaap:ProductMember country:US 2025-07-01 2025-09-30 0001579428 axsm:SunosiMember us-gaap:ProductMember 2024-01-01 2024-09-30 0001579428 axsm:TwoThousandFifteenEquityCompensationPlanMember 2025-09-30 0001579428 axsm:AXS-14Member 2024-07-01 2024-09-30 0001579428 axsm:SunosiMember us-gaap:ProductMember 2024-07-01 2024-09-30 0001579428 2024-01-01 2024-09-30 0001579428 axsm:LeerinkMember srt:MaximumMember axsm:MarchTwoThousandTwentyTwoSalesAgreementMember 2022-12-01 2022-12-31 0001579428 us-gaap:LicenseAgreementTermsMember axsm:PfizerIncMember 2020-01-09 0001579428 us-gaap:RetainedEarningsMember 2025-09-30 0001579428 us-gaap:SalesRevenueNetMember us-gaap:CustomerConcentrationRiskMember axsm:CustomerThreeMember 2025-01-01 2025-09-30 0001579428 axsm:ContingentConsiderationMember us-gaap:FairValueInputsLevel3Member us-gaap:MeasurementInputDiscountRateMember us-gaap:IncomeApproachValuationTechniqueMember 2025-09-30 0001579428 us-gaap:AdditionalPaidInCapitalMember 2024-12-31 0001579428 us-gaap:RetainedEarningsMember 2024-07-01 2024-09-30 0001579428 us-gaap:CommonStockMember 2025-01-01 2025-03-31 0001579428 us-gaap:ProductMember country:US 2025-01-01 2025-09-30 0001579428 axsm:PerformanceStockUnitsMember 2025-01-01 2025-09-30 0001579428 us-gaap:WarrantMember axsm:TermLoan2020TrancheOneMember 2025-01-01 2025-09-30 0001579428 us-gaap:RetainedEarningsMember 2025-04-01 2025-06-30 0001579428 us-gaap:AdditionalPaidInCapitalMember 2025-07-01 2025-09-30 0001579428 axsm:IncrementalTermLoansMember axsm:BlackstoneLoanAgreementMember 2025-05-08 0001579428 axsm:PerformanceStockUnitsMember srt:MaximumMember 2025-02-01 2025-02-28 0001579428 2023-12-31 0001579428 axsm:HerculesLoanAgreementMember 2025-09-30 0001579428 us-gaap:FairValueInputsLevel3Member axsm:ContingentConsiderationMember us-gaap:MeasurementInputRevenueMultipleMember us-gaap:IncomeApproachValuationTechniqueMember srt:MaximumMember 2025-09-30 0001579428 us-gaap:RevolvingCreditFacilityMember axsm:BlackstoneLoanAgreementMember 2025-09-30 0001579428 2025-04-01 2025-06-30 0001579428 us-gaap:LicenseAgreementTermsMember srt:AffiliatedEntityMember 2024-01-01 2024-09-30 0001579428 axsm:SolriamfetolMember 2025-07-01 2025-09-30 0001579428 us-gaap:SalesRevenueNetMember axsm:CustomerOneMember us-gaap:CustomerConcentrationRiskMember 2025-01-01 2025-09-30 0001579428 us-gaap:CommonStockMember axsm:BlackstoneLoanAgreementMember 2025-05-08 0001579428 axsm:FirstAmendmentMember axsm:LeasedOfficeSpaceMember 2025-01-01 2025-09-30 0001579428 us-gaap:AdditionalPaidInCapitalMember 2024-03-31 0001579428 us-gaap:CommonStockMember 2025-03-31 0001579428 us-gaap:LicenseAgreementTermsMember axsm:PfizerIncMember 2020-01-01 2020-12-31 0001579428 us-gaap:GeneralAndAdministrativeExpenseMember 2025-01-01 2025-09-30 0001579428 axsm:AXS-07Member 2025-01-01 2025-09-30 0001579428 us-gaap:RetainedEarningsMember 2024-01-01 2024-03-31 0001579428 us-gaap:NonUsMember us-gaap:ProductMember 2024-07-01 2024-09-30 0001579428 axsm:AXS-05Member 2025-01-01 2025-09-30 0001579428 us-gaap:WarrantMember 2025-01-01 2025-09-30 0001579428 us-gaap:NonUsMember us-gaap:ProductMember 2025-07-01 2025-09-30 0001579428 us-gaap:CommonStockMember 2024-03-31 0001579428 us-gaap:EmployeeStockMember 2025-07-01 2025-09-30 0001579428 axsm:SolriamfetolMember 2024-07-01 2024-09-30 0001579428 us-gaap:WarrantMember 2024-07-01 2024-09-30 0001579428 axsm:SymbravoMember us-gaap:RoyaltyMember 2024-01-01 2024-09-30 0001579428 us-gaap:RetainedEarningsMember 2025-06-30 0001579428 srt:MinimumMember srt:ChiefExecutiveOfficerMember 2025-09-30 0001579428 us-gaap:EmployeeStockMember 2025-01-01 2025-09-30 0001579428 axsm:HerculesLoanAgreementMember 2025-05-08 2025-05-08 0001579428 us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-09-30 0001579428 us-gaap:WarrantMember axsm:TermLoanTwoThousandAndTwentyThreeWarrantsMember 2025-09-30 0001579428 axsm:AXS-14Member 2025-01-01 2025-09-30 0001579428 us-gaap:LicenseAgreementTermsMember axsm:PfizerIncMember 2025-01-01 2025-09-30 0001579428 srt:ScenarioForecastMember 2025-01-01 2025-12-31 0001579428 us-gaap:AdditionalPaidInCapitalMember 2024-01-01 2024-03-31 0001579428 axsm:SunosiMember axsm:JazzPharmaceuticalsPlcMember 2022-03-24 2022-03-25 0001579428 axsm:AXS-05Member 2025-07-01 2025-09-30 0001579428 2024-04-01 2024-06-30 0001579428 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2024-12-31 0001579428 us-gaap:CommonStockMember axsm:BlackstoneLoanAgreementMember 2025-05-08 2025-05-08 0001579428 us-gaap:FairValueMeasurementsRecurringMember 2024-12-31 0001579428 axsm:SymbravoMember us-gaap:RoyaltyMember 2025-01-01 2025-09-30 0001579428 2025-01-01 2025-03-31 0001579428 us-gaap:AdditionalPaidInCapitalMember 2025-06-30 0001579428 us-gaap:WarrantMember 2025-01-01 2025-09-30 0001579428 us-gaap:WarrantMember 2024-01-01 2024-09-30 0001579428 axsm:FirstLienSeniorSecuredTermLoanMember axsm:BlackstoneLoanAgreementMember 2025-05-08 0001579428 axsm:AXS-14Member 2024-01-01 2024-09-30 0001579428 axsm:SeniorSecuredTermToanAvailableUntilMay312027Member axsm:BlackstoneLoanAgreementMember 2025-05-08 0001579428 axsm:MarkSaadMember 2025-07-01 2025-09-30 0001579428 axsm:SunosiMember us-gaap:RoyaltyMember 2024-07-01 2024-09-30 0001579428 axsm:JuneTwoThousandTwentyThreePublicOfferingMember 2023-06-01 2023-06-30 0001579428 us-gaap:RetainedEarningsMember 2025-03-31 0001579428 us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-09-30 0001579428 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2025-09-30 0001579428 us-gaap:NonUsMember us-gaap:ProductMember 2024-01-01 2024-09-30 0001579428 us-gaap:CommonStockMember 2025-09-30 0001579428 us-gaap:RetainedEarningsMember 2024-09-30 0001579428 axsm:PharmanoviaMember us-gaap:LicenseAgreementTermsMember 2024-07-01 2024-09-30 0001579428 us-gaap:ResearchAndDevelopmentExpenseMember 2024-07-01 2024-09-30 0001579428 2025-06-30 0001579428 axsm:PerformanceStockUnitsMember 2025-09-30 0001579428 srt:AffiliatedEntityMember 2012-01-01 2012-01-31 0001579428 axsm:AXS-07Member 2025-07-01 2025-09-30 0001579428 us-gaap:ProductMember 2024-07-01 2024-09-30 0001579428 us-gaap:CommonStockMember axsm:BlackstoneSecuritiesPurchaseAgreementMember us-gaap:PrivatePlacementMember 2025-05-01 2025-05-31 0001579428 axsm:AXS-07Member 2024-07-01 2024-09-30 0001579428 us-gaap:AdditionalPaidInCapitalMember 2025-01-01 2025-03-31 0001579428 us-gaap:RestrictedStockUnitsRSUMember 2025-09-30 0001579428 us-gaap:LicenseAgreementTermsMember axsm:PfizerIncMember 2020-01-31 0001579428 us-gaap:RetainedEarningsMember 2024-04-01 2024-06-30 0001579428 axsm:SunosiMember us-gaap:ProductMember 2025-01-01 2025-09-30 0001579428 us-gaap:CommonStockMember axsm:JuneTwoThousandTwentyThreePublicOfferingMember 2023-06-30 0001579428 us-gaap:WarrantMember 2024-01-01 2024-09-30 0001579428 us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2025-09-30 0001579428 us-gaap:RestrictedStockUnitsRSUMember 2024-01-01 2024-09-30 0001579428 us-gaap:RetainedEarningsMember 2024-06-30 0001579428 axsm:AuvelityMember 2025-01-01 2025-09-30 0001579428 us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2024-12-31 0001579428 axsm:BlackstoneLoanAgreementMember 2025-09-30 0001579428 us-gaap:WarrantMember axsm:TermLoan2020TrancheOneMember 2025-09-30 0001579428 us-gaap:ProductMember axsm:AuvelityMember 2024-01-01 2024-09-30 0001579428 us-gaap:CommonStockMember axsm:BlackstoneSecuritiesPurchaseAgreementMember us-gaap:PrivatePlacementMember 2025-05-31 0001579428 2024-09-30 0001579428 axsm:MarchTwoThousandTwentyTwoSalesAgreementMember 2025-01-01 2025-09-30 0001579428 axsm:AXS-14Member 2025-07-01 2025-09-30 0001579428 axsm:ContingentConsiderationMember us-gaap:FairValueInputsLevel3Member srt:MinimumMember us-gaap:MeasurementInputRevenueMultipleMember us-gaap:IncomeApproachValuationTechniqueMember 2024-12-31 0001579428 us-gaap:GeneralAndAdministrativeExpenseMember 2024-07-01 2024-09-30 0001579428 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2025-09-30 0001579428 2024-12-31 0001579428 us-gaap:AdditionalPaidInCapitalMember 2024-09-30 0001579428 us-gaap:RestrictedStockUnitsRSUMember 2024-12-31 0001579428 us-gaap:RetainedEarningsMember 2024-03-31 0001579428 axsm:SuperSeniorRevolvingCreditFacilityMember axsm:BlackstoneLoanAgreementMember 2025-05-08 0001579428 2024-06-30 0001579428 us-gaap:RetainedEarningsMember 2025-07-01 2025-09-30 0001579428 axsm:AXS-12Member 2025-07-01 2025-09-30 0001579428 us-gaap:PerformanceSharesMember 2025-01-01 2025-09-30 0001579428 us-gaap:ProductMember country:US 2024-01-01 2024-09-30 0001579428 axsm:SunosiMember us-gaap:ProductMember 2025-07-01 2025-09-30 0001579428 2025-09-30 0001579428 2025-03-31 0001579428 axsm:SymbravoMember us-gaap:RoyaltyMember 2025-07-01 2025-09-30 0001579428 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2024-12-31 0001579428 us-gaap:FairValueMeasurementsRecurringMember 2025-09-30 0001579428 axsm:SunosiMember 2025-01-01 2025-09-30 0001579428 us-gaap:NonUsMember us-gaap:RoyaltyMember 2025-07-01 2025-09-30 0001579428 axsm:MarkSaadMember 2025-09-30 0001579428 us-gaap:ProductMember axsm:AuvelityMember 2025-01-01 2025-09-30 0001579428 axsm:SunosiMember us-gaap:RoyaltyMember 2025-07-01 2025-09-30 0001579428 axsm:SunosiMember us-gaap:RoyaltyMember 2025-01-01 2025-09-30 0001579428 axsm:AXS-12Member 2024-01-01 2024-09-30 0001579428 axsm:JuneTwoThousandTwentyThreePublicOfferingMember 2023-06-30 0001579428 us-gaap:ProductMember country:US 2024-07-01 2024-09-30 0001579428 us-gaap:EmployeeStockOptionMember 2025-01-01 2025-09-30 0001579428 us-gaap:LicenseAgreementTermsMember srt:AffiliatedEntityMember 2012-01-01 2012-12-31 0001579428 us-gaap:CommonStockMember 2025-06-30 0001579428 axsm:AXS-05Member 2024-07-01 2024-09-30 0001579428 axsm:PharmanoviaMember us-gaap:LicenseAgreementTermsMember 2025-01-01 2025-09-30 0001579428 axsm:JuneTwoThousandTwentyThreePublicOfferingMember 2023-07-01 2023-07-31 0001579428 us-gaap:WarrantMember axsm:TermLoanTwoThousandAndTwentyTwoWarrantsMember 2025-09-30 0001579428 axsm:ThirdAmendmentToLoanAndSecurityAgreementMember us-gaap:WarrantMember axsm:HerculesCapitalIncMember 2025-09-30 0001579428 us-gaap:LicenseAgreementTermsMember srt:AffiliatedEntityMember srt:MaximumMember axsm:OtherTwoProductsMember 2012-01-01 2012-12-31 0001579428 us-gaap:SalesRevenueNetMember us-gaap:CustomerConcentrationRiskMember axsm:CustomerTwoMember 2025-01-01 2025-09-30 0001579428 us-gaap:LicenseAgreementTermsMember axsm:PfizerIncMember 2024-07-01 2024-09-30 0001579428 us-gaap:RetainedEarningsMember 2025-01-01 2025-03-31 0001579428 us-gaap:LicenseAgreementTermsMember axsm:PfizerIncMember 2025-09-30 0001579428 us-gaap:RestrictedStockUnitsRSUMember 2025-01-01 2025-09-30 0001579428 us-gaap:ResearchAndDevelopmentExpenseMember 2025-07-01 2025-09-30 0001579428 us-gaap:CommonStockMember 2023-12-31 0001579428 2025-07-01 2025-09-30 0001579428 us-gaap:NonUsMember us-gaap:RoyaltyMember 2024-07-01 2024-09-30 0001579428 srt:MaximumMember 2025-09-30 0001579428 us-gaap:RoyaltyMember 2024-01-01 2024-09-30 0001579428 axsm:AXS-12Member 2024-07-01 2024-09-30 0001579428 axsm:SolriamfetolMember 2024-01-01 2024-09-30 0001579428 2025-01-01 2025-09-30 0001579428 us-gaap:ProductMember 2025-07-01 2025-09-30 0001579428 axsm:AXS-05Member 2024-01-01 2024-09-30 0001579428 axsm:BlackstoneLoanAgreementMember axsm:TermLoansMember 2025-01-01 2025-09-30 0001579428 axsm:Axs05Member us-gaap:LicenseAgreementTermsMember srt:AffiliatedEntityMember 2012-01-01 2012-12-31 0001579428 axsm:SolriamfetolMember 2025-01-01 2025-09-30 0001579428 us-gaap:CommonStockMember 2024-12-31 0001579428 axsm:AuvelityMember 2024-01-01 2024-09-30 0001579428 us-gaap:CommonStockMember 2024-09-30 0001579428 us-gaap:NonUsMember us-gaap:RoyaltyMember 2024-01-01 2024-09-30 0001579428 us-gaap:GeneralAndAdministrativeExpenseMember 2025-07-01 2025-09-30 0001579428 us-gaap:RetainedEarningsMember 2024-12-31 0001579428 axsm:AriMaizelMember 2025-07-01 2025-09-30 0001579428 axsm:MarchTwoThousandTwentyTwoSalesAgreementMember 2025-07-01 2025-09-30 0001579428 us-gaap:AdditionalPaidInCapitalMember 2023-12-31 0001579428 us-gaap:CommonStockMember 2025-07-01 2025-09-30 0001579428 axsm:SeniorSecuredTermToanAvailableUntilMay312026Member axsm:BlackstoneLoanAgreementMember 2025-05-08 0001579428 us-gaap:AdditionalPaidInCapitalMember 2025-09-30 0001579428 axsm:SunosiMember 2024-01-01 2024-09-30 0001579428 axsm:BlackstoneLoanAgreementMember axsm:SeniorSecuredTermLoanMember 2025-05-08 0001579428 us-gaap:ProductMember axsm:AuvelityMember 2025-07-01 2025-09-30 0001579428 us-gaap:LicenseAgreementTermsMember srt:AffiliatedEntityMember 2025-01-01 2025-09-30 0001579428 us-gaap:RoyaltyMember 2025-01-01 2025-09-30 0001579428 axsm:BlackstoneSecuritiesPurchaseAgreementMember us-gaap:PrivatePlacementMember 2025-05-01 2025-05-31 0001579428 us-gaap:CommonStockMember 2024-07-01 2024-09-30 0001579428 srt:MinimumMember 2025-09-30 0001579428 us-gaap:EmployeeStockMember 2025-01-01 2025-09-30 0001579428 axsm:PharmanoviaMember us-gaap:LicenseAgreementTermsMember 2024-01-01 2024-09-30 0001579428 us-gaap:CommonStockMember axsm:JuneTwoThousandTwentyThreePublicOfferingMember 2023-07-01 2023-07-31 0001579428 us-gaap:LicenseAgreementTermsMember srt:AffiliatedEntityMember 2024-09-30 0001579428 us-gaap:NonUsMember us-gaap:ProductMember 2025-01-01 2025-09-30 0001579428 axsm:SunosiMember 2022-03-24 2022-03-25 0001579428 us-gaap:RestrictedStockUnitsRSUMember 2025-01-01 2025-09-30 0001579428 us-gaap:NonUsMember us-gaap:RoyaltyMember 2025-01-01 2025-09-30 0001579428 axsm:BlackstoneLoanAgreementMember axsm:TermLoansMember 2025-09-30 0001579428 us-gaap:LicenseAgreementTermsMember axsm:PfizerIncMember 2024-01-01 2024-09-30 0001579428 axsm:BlackstoneLoanAgreementMember 2025-05-08 2025-05-08 0001579428 us-gaap:WarrantMember 2025-07-01 2025-09-30 0001579428 us-gaap:EmployeeStockMember 2024-01-01 2024-09-30 0001579428 axsm:ContingentConsiderationMember us-gaap:FairValueInputsLevel3Member srt:MinimumMember us-gaap:MeasurementInputRevenueMultipleMember us-gaap:IncomeApproachValuationTechniqueMember 2025-09-30 0001579428 us-gaap:ResearchAndDevelopmentExpenseMember 2025-01-01 2025-09-30 0001579428 us-gaap:RoyaltyMember 2025-07-01 2025-09-30 0001579428 us-gaap:LicenseAgreementTermsMember srt:AffiliatedEntityMember 2025-09-30 0001579428 us-gaap:CommonStockMember 2024-06-30 0001579428 2025-10-27 0001579428 us-gaap:LicenseAgreementTermsMember axsm:PfizerIncMember 2025-07-01 2025-09-30 0001579428 us-gaap:CommonStockMember 2025-04-01 2025-06-30 0001579428 axsm:FirstAmendmentMember 2025-09-30 0001579428 us-gaap:LicenseAgreementTermsMember srt:MinimumMember srt:AffiliatedEntityMember axsm:OtherTwoProductsMember 2012-01-01 2012-12-31 0001579428 us-gaap:AccountingStandardsUpdate202309Member 2025-09-30 0001579428 us-gaap:ProductMember axsm:AuvelityMember 2024-07-01 2024-09-30 0001579428 us-gaap:AdditionalPaidInCapitalMember 2024-04-01 2024-06-30 0001579428 us-gaap:LicenseAgreementTermsMember axsm:PfizerIncMember 2020-01-01 2020-01-31 0001579428 axsm:PharmanoviaMember us-gaap:LicenseAgreementTermsMember 2025-07-01 2025-09-30 0001579428 axsm:AXS-07Member 2024-01-01 2024-09-30 0001579428 axsm:JuneTwoThousandTwentyThreePublicOfferingMember 2023-07-31 0001579428 us-gaap:RetainedEarningsMember 2023-12-31 0001579428 us-gaap:CommonStockMember 2024-04-01 2024-06-30 0001579428 2024-01-01 2024-03-31 0001579428 axsm:SunosiMember us-gaap:RoyaltyMember 2024-01-01 2024-09-30 0001579428 axsm:SymbravoMember us-gaap:RoyaltyMember 2024-07-01 2024-09-30 0001579428 us-gaap:CommonStockMember 2024-01-01 2024-03-31 0001579428 axsm:ContingentConsiderationMember us-gaap:FairValueInputsLevel3Member us-gaap:MeasurementInputDiscountRateMember us-gaap:IncomeApproachValuationTechniqueMember 2024-12-31 0001579428 axsm:SunosiMember 2025-09-30 0001579428 us-gaap:CommonStockMember axsm:JuneTwoThousandTwentyThreePublicOfferingMember 2023-07-31 0001579428 us-gaap:AdditionalPaidInCapitalMember 2025-03-31 0001579428 2024-03-31 0001579428 axsm:NickPizzieMember 2025-07-01 2025-09-30 0001579428 axsm:JuneTwoThousandTwentyThreePublicOfferingMember 2025-01-01 2025-09-30 0001579428 us-gaap:RevolvingCreditFacilityMember axsm:BlackstoneLoanAgreementMember 2025-01-01 2025-09-30 0001579428 axsm:NickPizzieMember 2025-09-30 iso4217:USD xbrli:shares axsm:Segment iso4217:EUR axsm:Days xbrli:pure axsm:Customer xbrli:shares axsm:Item axsm:ReportingUnits axsm:Institution axsm:Market iso4217:USD

Table of Contents

 

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2025
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 001-37635
 
AXSOME THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 

Delaware

45-4241907

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

 

One World Trade Center
29th Floor
New York , New York

10007

(Address of principal executive offices)

(Zip Code)

 
Registrant’s telephone number, including area code: ( 212 ) 332-3241
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 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 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

☒

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 ☒
Securities registered pursuant to Section 12(b) of the Act:
 

Title of each class:

 

Trading Symbol(s)

 

Name of each exchange on which registered:

Common Stock, Par Value $0.0001 Per Share

 

AXSM

 

The Nasdaq Global Market

 
There were 50,412,640 shares of the registrant’s common stock, $0.0001 par value, outstanding as of October 27, 2025.
 

 

Table of Contents

 

AXSOME THERAPEUTICS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED September 30, 2025
 
TABLE OF C ONTENTS
 

 

 

 

Page

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

 

3

 

 

 

PART I — FINANCIAL INFORMATION

 

 

 

 

 

 

ITEM 1

Financial Statements

 

4

ITEM 2

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

36

ITEM 3

Quantitative and Qualitative Disclosure About Market Risk

 

47

ITEM 4

Controls and Procedures

 

47

 

 

 

PART II — OTHER INFORMATION

 

 

 

 

 

 

ITEM 1

Legal Proceedings

 

48

ITEM 1A

Risk Factors

 

50

ITEM 5

Other Information

 

111

ITEM 6

Exhibits

 

113

 

Signature s

 

114

 

2

Table of Contents

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain matters discussed in this report, including matters discussed under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended, or the Securities Act, and the Securities Exchange Act of 1934, as amended, or the Exchange Act, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the future results, performance or achievements expressed or implied by such forward-looking statements. The words “anticipate,” “believe,” “estimate,” “may,” “expect” and similar expressions are generally intended to identify forward-looking statements. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation, those discussed under the captions “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this report, as well as other factors which may be identified from time to time in our other filings with the U.S. Securities and Exchange Commission, or the SEC, or in the documents where such forward-looking statements appear. All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by these cautionary statements. Such forward-looking statements include, but are not limited to, statements about:
• our expectations for increases or decreases in expenses;

• our expectations for the clinical and preclinical development, manufacturing and regulatory approval of our product candidates, and commercialization of our pharmaceutical products or any other products that we may acquire or in-license;

• our estimates of the sufficiency of our existing capital resources combined with future anticipated cash flows to finance our operating requirements;

• our expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities;

• unforeseen circumstances or other disruptions to normal business operations arising from or related to geopolitical conflicts or pandemics;

• our future revenue projections, sales forecasts, and potential peak market data;

• our expectations for generating revenue or becoming profitable on a sustained basis;

• our expectations or ability to enter into marketing and other partnership agreements;

• our expectations or ability to enter into product acquisitions and in-licensing transactions;

• our expectations or ability to build our own commercial infrastructure to manufacture, market and sell our products;

• our expected losses;

• our ability to obtain and maintain intellectual property protection for our products;

• the acceptance of our products by doctors, patients, or payors;

• our stock price and its volatility;

• our ability to attract and retain key personnel;

• the performance of third-party manufacturers;

• our expectations for future capital requirements; and

• our ability to successfully implement our strategy.

The forward-looking statements contained in this report reflect our views and assumptions only as of the date that this report is signed. Except as required by law, we assume no responsibility for updating any forward-looking statements.
We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

3

Table of Contents

 

PART I. FINANC IAL INFORMATION
ITEM 1. FINANC IAL STATEMENTS
Axsome Therapeutics, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)

 

 

September 30,
2025

 

 

December 31,
2024

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

325,272

 

 

$

315,353

 

Accounts receivable, net

 

 

196,507

 

 

 

142,001

 

Inventories, net

 

 

23,774

 

 

 

15,732

 

Prepaid and other current assets

 

 

19,789

 

 

 

11,978

 

Total current assets

 

 

565,342

 

 

 

485,064

 

Equipment, net

 

 

605

 

 

 

584

 

Right-of-use asset - operating lease

 

 

21,654

 

 

 

5,383

 

Goodwill

 

 

12,042

 

 

 

12,042

 

Intangible asset, net

 

 

42,126

 

 

 

46,894

 

Non-current inventory and other assets

 

 

27,481

 

 

 

18,531

 

Total assets

 

$

669,250

 

 

$

568,498

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

54,227

 

 

$

71,997

 

Accrued expenses and other current liabilities

 

 

225,632

 

 

 

147,987

 

Operating lease liability, current portion

 

 

736

 

 

 

1,835

 

Contingent consideration, current

 

 

9,695

 

 

 

8,285

 

Short-term borrowings

 

 

70,000

 

 

 

—

 

Total current liabilities

 

 

360,290

 

 

 

230,104

 

Contingent consideration, non-current

 

 

89,870

 

 

 

91,680

 

Loan payable, long-term

 

 

117,642

 

 

 

180,710

 

Operating lease liability, long-term

 

 

23,041

 

 

 

6,046

 

Finance lease liability, long-term

 

 

4,680

 

 

 

2,943

 

Total liabilities

 

 

595,523

 

 

 

511,483

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $ 0.0001  par value per share ( 10,000,000  shares authorized, none  issued and outstanding)

 

 

—

 

 

 

—

 

Common stock, $ 0.0001  par value per share ( 150,000,000  shares authorized, 50,307,834  and 48,667,587  shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively)

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

1,351,124

 

 

 

1,179,797

 

Accumulated deficit

 

 

( 1,277,402

)

 

 

( 1,122,787

)

Total stockholders’ equity

 

 

73,727

 

 

 

57,015

 

Total liabilities and stockholders’ equity

 

$

669,250

 

 

$

568,498

 

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

4

Table of Contents

 

Axsome Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(In thousands, except share and per share amounts)

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

169,784

 

 

$

103,736

 

 

$

439,101

 

 

$

264,352

 

Royalty revenue

 

 

1,208

 

 

 

1,026

 

 

 

3,396

 

 

 

2,575

 

Total revenues

 

 

170,992

 

 

 

104,762

 

 

 

442,497

 

 

 

266,927

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue (excluding amortization and depreciation)

 

 

11,912

 

 

 

8,437

 

 

 

35,149

 

 

 

22,789

 

Research and development

 

 

40,162

 

 

 

45,388

 

 

 

134,488

 

 

 

132,071

 

Selling, general and administrative

 

 

150,235

 

 

 

95,564

 

 

 

401,302

 

 

 

298,088

 

Loss in fair value of contingent consideration

 

 

13,185

 

 

 

16,391

 

 

 

6,595

 

 

 

17,139

 

Intangible asset amortization

 

 

1,607

 

 

 

1,606

 

 

 

4,768

 

 

 

4,785

 

Total operating expenses

 

 

217,101

 

 

 

167,386

 

 

 

582,302

 

 

 

474,872

 

Loss from operations

 

 

( 46,109

)

 

 

( 62,624

)

 

 

( 139,805

)

 

 

( 207,945

)

Interest expense, net

 

 

( 1,120

)

 

 

( 1,978

)

 

 

( 5,385

)

 

 

( 4,359

)

Loss on debt extinguishment

 

 

—

 

 

 

—

 

 

 

( 10,385

)

 

 

—

 

Loss before income taxes

 

 

( 47,229

)

 

 

( 64,602

)

 

 

( 155,575

)

 

 

( 212,304

)

Income tax benefit

 

 

—

 

 

 

—

 

 

 

960

 

 

 

—

 

Net loss

 

$

( 47,229

)

 

$

( 64,602

)

 

$

( 154,615

)

 

$

( 212,304

)

Net loss per common share, basic and diluted

 

$

( 0.94

)

 

$

( 1.34

)

 

$

( 3.13

)

 

$

( 4.45

)

Weighted average common shares outstanding, basic and diluted

 

 

50,021,851

 

 

 

48,140,519

 

 

 

49,449,220

 

 

 

47,703,508

 

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

5

Table of Contents

 

Axsome Therapeutics, Inc.
Consolidated Statements of Stockholders’ Equity (Unaudited)
(In thousands, except share amounts)

 

 

Common stock

 

 

Additional paid-in

 

 

Accumulated

 

 

Total
stockholders’

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

deficit

 

 

equity

 

Balance at December 31, 2023

 

 

47,351,363

 

 

 

5

 

 

 

1,026,543

 

 

 

( 835,571

)

 

 

190,977

 

Stock-based compensation

 

 

—

 

 

 

—

 

 

 

20,533

 

 

 

—

 

 

 

20,533

 

Issuance of common stock upon exercise of options

 

 

80,294

 

 

 

—

 

 

 

2,501

 

 

 

—

 

 

 

2,501

 

Issuance of common stock upon vesting of RSUs

 

 

32,918

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Shares tendered for withholding taxes

 

 

—

 

 

 

—

 

 

 

( 1,618

)

 

 

—

 

 

 

( 1,618

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 68,357

)

 

 

( 68,357

)

Balance at March 31, 2024

 

 

47,464,575

 

 

 

5

 

 

 

1,047,959

 

 

 

( 903,928

)

 

 

144,036

 

Stock-based compensation

 

 

—

 

 

 

—

 

 

 

21,709

 

 

 

—

 

 

 

21,709

 

Issuance of common stock upon exercise of options and under employee stock purchase plan

 

 

160,724

 

 

 

—

 

 

 

6,741

 

 

 

—

 

 

 

6,741

 

Issuance of common stock upon vesting of RSUs

 

 

27,404

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon financing

 

 

148,875

 

 

 

—

 

 

 

11,039

 

 

 

—

 

 

 

11,039

 

Shares tendered for withholding taxes

 

 

—

 

 

 

—

 

 

 

( 1,328

)

 

 

—

 

 

 

( 1,328

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 79,345

)

 

 

( 79,345

)

Balance at June 30, 2024

 

 

47,801,57 8

 

 

 

5

 

 

 

1,086,120

 

 

 

( 983,273

)

 

 

102,852

 

Stock-based compensation

 

 

—

 

 

 

—

 

 

 

21,992

 

 

 

—

 

 

 

21,992

 

Issuance of common stock upon exercise of options

 

 

475,830

 

 

 

—

 

 

 

20,290

 

 

 

—

 

 

 

20,290

 

Issuance of common stock upon vesting of RSUs

 

 

10,440

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon financing

 

 

148,260

 

 

 

—

 

 

 

12,839

 

 

 

—

 

 

 

12,839

 

Shares tendered for withholding taxes

 

 

—

 

 

 

—

 

 

 

( 473

)

 

 

—

 

 

 

( 473

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 64,602

)

 

 

( 64,602

)

Balance at September 30, 2024

 

 

48,436,108

 

 

 

5

 

 

 

1,140,768

 

 

 

( 1,047,875

)

 

 

92,898

 

Balance at December 31, 2024

 

 

48,667,587

 

 

 

5

 

 

 

1,179,797

 

 

 

( 1,122,787

)

 

 

57,015

 

Stock-based compensation

 

 

—

 

 

 

—

 

 

 

23,647

 

 

 

—

 

 

 

23,647

 

Issuance of common stock upon exercise of options

 

 

331,853

 

 

 

—

 

 

 

17,035

 

 

 

—

 

 

 

17,035

 

Issuance of common stock upon vesting of RSUs

 

 

60,835

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon financing

 

 

156,484

 

 

 

—

 

 

 

19,257

 

 

 

—

 

 

 

19,257

 

Shares tendered for withholding taxes

 

 

—

 

 

 

—

 

 

 

( 4,336

)

 

 

—

 

 

 

( 4,336

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 59,413

)

 

 

( 59,413

)

Balance at March 31, 2025

 

 

49,216,759

 

 

 

5

 

 

 

1,235,400

 

 

 

( 1,182,200

)

 

 

53,205

 

Stock-based compensation

 

 

—

 

 

 

—

 

 

 

24,954

 

 

 

—

 

 

 

24,954

 

Issuance of common stock upon exercise of options and under employee stock purchase plan

 

 

276,280

 

 

 

—

 

 

 

11,661

 

 

 

—

 

 

 

11,661

 

Issuance of common stock upon vesting of RSUs

 

 

15,776

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon financing

 

 

306,486

 

 

 

—

 

 

 

32,116

 

 

 

—

 

 

 

32,116

 

Shares tendered for withholding taxes

 

 

—

 

 

 

—

 

 

 

( 888

)

 

 

—

 

 

 

( 888

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 47,973

)

 

 

( 47,973

)

Balance at June 30, 2025

 

 

49,815,301

 

 

 

5

 

 

 

1,303,243

 

 

 

( 1,230,173

)

 

 

73,075

 

Stock-based compensation

 

 

—

 

 

 

—

 

 

 

23,442

 

 

 

—

 

 

 

23,442

 

Issuance of common stock upon exercise of options

 

 

389,542

 

 

 

—

 

 

 

15,524

 

 

 

—

 

 

 

15,524

 

Issuance of common stock upon vesting of RSUs

 

 

14,479

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon financing

 

 

88,512

 

 

 

—

 

 

 

9,757

 

 

 

—

 

 

 

9,757

 

Shares tendered for withholding taxes

 

 

—

 

 

 

—

 

 

 

( 842

)

 

 

—

 

 

 

( 842

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 47,229

)

 

 

( 47,229

)

Balance at September 30, 2025

 

 

50,307,834

 

 

$

5

 

 

$

1,351,124

 

 

$

( 1,277,402

)

 

$

73,727

 

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

6

Table of Contents

 

Axsome Therapeutics, Inc.
Consolidated Statements of Cash Flows (Unaudited)
(In thousands)

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

( 154,615

)

 

$

( 212,304

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

71,022

 

 

 

63,232

 

Amortization of intangible asset

 

 

4,768

 

 

 

4,785

 

Amortization of debt discount

 

 

1,142

 

 

 

1,932

 

Loss on debt extinguishment

 

 

10,385

 

 

 

—

 

Depreciation

 

 

389

 

 

 

403

 

Loss in fair value of contingent consideration

 

 

6,595

 

 

 

17,139

 

Gain from lease modification

 

 

( 2,250

)

 

 

—

 

Non-cash lease expense

 

 

2,249

 

 

 

1,042

 

Right-of-use asset amortization for finance lease

 

 

1,633

 

 

 

697

 

Change in operating lease liability

 

 

( 373

)

 

 

( 235

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable, net

 

 

( 54,506

)

 

 

( 29,276

)

Inventories, net

 

 

( 7,020

)

 

 

1,873

 

Prepaid expenses and other current assets

 

 

( 7,811

)

 

 

( 5,296

)

Non-current inventory and other assets

 

 

( 5,159

)

 

 

( 169

)

Accounts payable

 

 

( 17,770

)

 

 

23,574

 

Accrued expenses and other current liabilities

 

 

76,569

 

 

 

30,395

 

Net cash used in operating activities

 

 

( 74,752

)

 

 

( 102,208

)

Cash flows from investing activities

 

 

 

 

 

 

Purchases of equipment

 

 

( 409

)

 

 

( 240

)

Net cash used in investing activities

 

 

( 409

)

 

 

( 240

)

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from draw down of debt

 

 

260,000

 

 

 

—

 

Payment of debt issuance costs

 

 

( 3,638

)

 

 

—

 

Repayment of debt

 

 

( 261,988

)

 

 

—

 

Payments on principal portion of finance lease obligation

 

 

( 1,583

)

 

 

( 660

)

Proceeds from issuance of common stock upon financing

 

 

62,229

 

 

 

24,365

 

Cash paid for common stock issuance costs

 

 

( 1,099

)

 

 

( 487

)

Proceeds from issuance of common stock upon exercise of options and under employee stock purchase plan

 

 

44,220

 

 

 

29,532

 

Payment of contingent consideration

 

 

( 6,995

)

 

 

( 5,735

)

Payments of tax withholdings on stock awards

 

 

( 6,066

)

 

 

( 3,419

)

Net cash provided by financing activities

 

 

85,080

 

 

 

43,596

 

Net increase (decrease) in cash

 

 

9,919

 

 

 

( 58,852

)

Cash at beginning of period

 

 

315,353

 

 

 

386,193

 

Cash at end of period

 

$

325,272

 

 

$

327,341

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

Interest paid

 

$

11,576

 

 

$

14,935

 

Operating lease right-of-use asset obtained in exchange for operating lease liability

 

 

23,869

 

 

 

—

 

Finance lease right-of-use asset obtained in exchange for finance lease liability

 

 

4,395

 

 

 

4,890

 

Decrease in operating lease right-of-use asset due to lease modification

 

 

5,349

 

 

 

—

 

Decrease in operating lease liability due to lease modification

 

 

7,599

 

 

 

—

 

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

7

Table of Contents

 

Axsome Therapeutics, Inc.
Notes to Consolidated Financial Statements (Unaudited)
(In thousands, except share and per share amounts)
Note 1. Nature of Business and Basis of Presentation
Axsome Therapeutics, Inc. (“Axsome” or the “Company”), based in New York, New York, is a biopharmaceutical company dedicated to the development and commercialization of innovative medicines for people living with central nervous system (“CNS”) conditions. Axsome has a diverse portfolio of U.S. Food and Drug Administration (FDA) approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, and migraine, and an expansive pipeline comprised of multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that collectively impact over 150 million people in the United States.
In May 2022, the Company acquired the U.S. rights to Sunosi ® (solriamfetol) from Jazz Pharmaceuticals plc (“Jazz”), and in November 2022, the Company acquired worldwide ex-U.S. rights (excluding certain Asian markets) from Jazz (collectively, the “Acquisition”). Sunosi was approved for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy or obstructive sleep apnea by the FDA in March 2019 and by the European Commission in January 2020. In February 2023, the Company announced a licensing transaction with Atnahs Pharma UK Limited (“Pharmanovia”) to market Sunosi in Europe and certain countries in the Middle East / North Africa.
In August 2022, Auvelity ® (dextromethorphan-bupropion) was approved by the FDA for the treatment of major depressive disorder in adults. The Company announced the commercial availability of Auvelity in the U.S. in October 2022.
In January 2025, Symbravo ® (MoSEIC TM meloxicam-rizatriptan) was approved by the FDA for the acute treatment of migraine with or without aura in adults. The Company announced the commercial availability of Symbravo in the U.S. in June 2025.
The Company refers herein to Auvelity, Sunosi, Symbravo (also referred to as “AXS-07”), AXS-12, AXS-14, and its programs to develop additional indications for AXS-05 and solriamfetol as the Company’s products.
The accompanying unaudited interim consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These unaudited interim consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 18, 2025.
In the opinion of management, the unaudited interim consolidated financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods. The results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the operating results for the full fiscal year or any future period.
Liquidity and Capital Resources
The Company has incurred operating losses since its inception and expects to continue to incur operating losses and may never become profitable. As of September 30, 2025, the Company had an accumulated deficit of $ 1,277.4 million.

8

Table of Contents

 

The Company’s primary sources of cash have been proceeds from the sales of Auvelity, Sunosi, Symbravo, the issuance and sale of its common stock in public offerings, and the issuance of debt. The Company’s ability to achieve profitability depends on a number of factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership with third parties. The Company may continue to incur substantial operating losses even as it continues to generate revenues from its products.
The Company believes its existing cash will be sufficient to fund its anticipated operating cash requirements for at least twelve months following the date of this filing. During that time, the Company expects that its expenses will increase primarily due to the commercialization of Auvelity, Sunosi, and Symbravo while continuing to further develop the Company’s pipeline assets. The Company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
The Company’s common stock is listed on The Nasdaq Global Market and trades under the symbol “AXSM.”

Note 2. Summary of Significant Accounting Policies
Significant Risks and Uncertainties
The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the Company’s ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Company’s products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise additional capital. If the Company’s commercialization of its products is not financially successful, it will be unable to generate sufficient recurring product revenue to achieve and maintain profitability.
The Company currently has three commercial products, Auvelity, Sunosi, and Symbravo. There can be no assurance that the Company’s research and development efforts will result in additional successfully commercialized products. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property.

Use of Estimates
Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made. In preparing these financial statements, management used significant estimates in the following areas, among others: stock-based compensation expense; determination of fair value of warrants; accounting for research and development costs; accounting for acquisitions; impairments of goodwill and the intangible asset; determination of fair value of contingent consideration; chargebacks, cash discounts, sales rebates, returns and other adjustments; and the recoverability of the Company’s net deferred tax assets and related valuation allowance.

9

Table of Contents

 

Revenue Recognition
In accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”) the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration that the Company expects to receive in exchange for the good or service. Transfer of control is based on contractual performance obligations, which occurs upon transfer of the title along with the physical transfer of the Company’s goods to the customer, as that is when the customer has obtained control of significantly all of the economic benefits and the Company obtains a right of payment.
To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under ASC 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses 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 a complete discussion of accounting for product sales, see Product Sales, net and Note 13. Revenues .

License Agreements
The Company generates revenue from license or similar agreements with pharmaceutical companies for the development and commercialization of certain products. Such agreements may include the transfer of intellectual property rights in the form of licenses. Payments made by the customer may include non-refundable upfront fees, payments based upon the achievement of defined milestones and royalties on sales of products.
If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes the transaction price allocated to the license as revenue upon transfer of control of the license. All other promised goods or services in the agreement are evaluated to determine if they are distinct. If they are not distinct, they are combined with other promised goods or services to create a bundle of promised goods or services that is distinct. Optional future services where any additional consideration paid to the Company reflects their standalone selling prices do not provide the customer with a material right, and, therefore, are not considered performance obligations. If optional future services are priced in a manner which provides the customer with a significant or incremental discount, they are material rights and are accounted for as separate performance obligations.
Contingent milestones at contract inception are estimated to the extent that it is probable that a significant revenue reversal would not occur and are included in the transaction price using the most likely amount method. Milestone payments that are not within the Company’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received, and, therefore, the variable consideration is constrained. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each reporting period, the Company re-evaluates the probability of achieving development or sales-based milestone payments that a significant revenue reversal would not occur and, if necessary, adjusts the estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and other revenue, as well as earnings, in the period of adjustment.
For arrangements that include sales-based royalties, including sales-based milestone payments, and a license of intellectual property that is deemed to be the predominant item to which the royalties relate, revenue is recognized at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalties have been allocated has been satisfied (or partially satisfied).

10

Table of Contents

 

Product Sales, net
Revenues from product sales are recorded net of reserves for variable consideration. These reserves reflect the Company’s best estimate of the amount of consideration to which the Company is entitled based on the terms of the contracts. The Company sells Auvelity, Sunosi, and Symbravo in the United States to wholesale distributors with whom the Company has entered into formal agreements (collectively, the “Distributors”). These Distributors subsequently resell the Company’s products to retail pharmacies. The Company also sells Sunosi to Distributors in Canada and on a product supply basis to Pharmanovia. Sunosi is subsequently sold by Pharmanovia in certain ex-U.S. markets. The Company does not sell products under consignment arrangements, and the collection of proceeds from product sales is not contingent upon customers’ sale of the goods to third parties. The Company received FDA approval for Symbravo in January 2025. See Note 13. Revenues for a further breakout of product sales, net.
Reserves for Variable Consideration
The Company’s estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of its anticipated performance and all information (historical, current and forecasted) that is reasonably available. These reserves reflect the Company’s best estimate of the amount of consideration to which the Company is entitled based on the terms of the contracts and are classified as reductions to accounts receivable, net if payable to a customer or accrued expenses and other current liabilities if payable to a third-party. The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that is considered 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 estimates. If actual results in the future vary from our estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
The provision for rebates, discounts, and other incentives is based on expected patient usage, as well as inventory levels in the distribution channel to determine the contractual obligation to the benefit providers. Additionally, sales are generally made with a limited right of return under certain conditions. Revenues are recorded net of provisions for rebates, discounts, and other incentives and returns, which are established at the time of sale. The Company uses customer segment utilization mix data, changes to product price, government pricing calculations and prior payment history in order to estimate the variable consideration. Amounts accrued for rebates, discounts, and other incentives are adjusted when trends indicate that adjustment is appropriate and to reflect actual experience.
Trade Discounts and Allowances - The Company generally provides discounts which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its distributors for distribution services and data. These payments have been recorded as a reduction to product sales as well as a reduction to accounts receivable, net on the consolidated balance sheets.
Product Returns - The Company generally offers a limited right of return for product that has been purchased from the Company based on the product’s expiration date. The Company estimates the amount of its product sales that may be returned and records this estimate as a reduction of revenue in the period the related product sale is recognized, as well as a component of accrued expense and other current liabilities. The Company currently estimates product return liabilities using available industry data, historical product sales information, and actual returns experience.
Chargebacks and Discounts - Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products at prices lower than the list prices charged to distributors. Distributors charge the Company for the difference between what they pay for the product and the ultimate selling price. These reserves are established in the same period that the related product sales are recognized, resulting in a reduction to product sales and accounts receivable, net.

11

Table of Contents

 

Rebates - Rebates apply to: Medicaid, managed care, and supplemental rebates to all applicable states as defined by the statutory government pricing calculation requirements under the Medicaid Drug Rebate Program. Tricare rebates to the TRICARE third-party administrator are based on the statutory calculation defined in the agreement with the Defense Health Agency. Part D and Commercial Managed Care rebates are paid based on the contracts with Pharmacy Benefit Managers (“PBMs”) and Managed Care Organizations. Rebates are paid to these entities upon receipt of an invoice from the contracted entity which is based on the utilization of the product by the members of the contracted entity. Allowances for rebates also include amounts due for Medicare Inflation Based Rebates resulting from the Inflation Reduction Act of 2022 which includes measures requiring manufacturers to pay rebates where price increases exceed the rate of inflation. The Company estimates these rebates and records such estimates in the same period the related product sales are recognized, resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities.
Coverage Gap - The Medicare Part D coverage gap is a period of consumer payment for prescription medication costs which lies between the initial coverage limit and the catastrophic-coverage threshold, when the patient is a member of a Medicare Part D prescription-drug program administered by the Centers for Medicare & Medicaid Services. The Company estimates the percentage of goods sold to patients in the Coverage Gap and adjusts the transaction price for such discount at the time of sale resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities.
Medicare Part D Program Redesign - Effective January 1, 2025, the Medicare Part D coverage gap program was replaced with a redesigned program under the Inflation Reduction Act of 2022. The standard Part D benefit now comprises three phases: the deductible phase, the initial coverage phase and the catastrophic coverage phase. Applicable dispensed drugs will be subject to manufacturer discounts of 10 % during the initial coverage phase and 20 % during the catastrophic coverage phase. The Company estimates the percentage of goods sold to patients in the initial coverage and catastrophic coverage phases and adjusts the transaction price for such discount at the time of sale resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities.
Other Incentives - Other incentives which the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue. The reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product sales as well as a component of accrued expenses and other current liabilities.
The Company makes significant estimates and judgments that materially affect its recognition of net product revenue. Claims by third-party payors for rebates, chargebacks and discounts frequently are submitted to the Company significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known. The Company will adjust its estimates based on new information, including information regarding actual rebates, chargebacks and discounts for its products, as it becomes available.

Cost of Revenue
The Company’s cost of revenue consists of cost of product sales. Cost of product sales primarily include direct costs (inclusive of material, shipping, handling, and manufacturing costs), overhead and product royalties. Cost of product sales excludes depreciation and amortization.
The Company assumed royalty and sales-based milestone commitments of Jazz to SK Biopharmaceuticals Co. Ltd. (“SK”) and Aerial Biopharma, LLC (“Aerial”). SK is the originator of Sunosi and retains rights in 12 Asian markets, including China, Korea and Japan. In 2014, Jazz acquired from Aerial worldwide rights to Sunosi excluding those Asian markets stated previously. The assumed commitments to SK and Aerial include single-digit tiered royalties based on the Company’s sales of Sunosi, and the Company is committed to pay up to $ 165.0 million based on revenue milestones and $ 1.0 million based on development milestones. Additionally, the Company pays a royalty to Antecip Bioventures II LLC (“Antecip”), an entity owned by Axsome’s Chief Executive Officer and Chairman of the Board of Directors (the “Board”), Herriot Tabuteau, M.D., equal to 3.0 % of Auvelity net sales.

12

Table of Contents

 

Foreign Currency Translation
Revenues and expenses denominated in foreign currency are translated into U.S. dollars at the exchange rate on the date they are incurred. Assets and liabilities of foreign operations are translated at period-end exchange rates. The effect of exchange rate fluctuations on translating foreign currency into U.S. dollars is included in the statements of operations and is not material to the Company’s consolidated financial statements.

Segment Information
Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision maker or decision-making group in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business as one operating and reporting segment, which is the business of developing and delivering novel therapies for the management of CNS disorders. See Note 18. Segment Information below for further information.

Cash and Cash Equivalents
The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. The Company’s cash and cash equivalents includes holdings in checking and overnight sweep accounts. The Company’s cash equivalents, which are money market funds held in a sweep account, are measured at fair value on a recurring basis. As of September 30, 2025, the balance of cash and cash equivalents was $ 325.3 million, which approximates fair value and was determined based upon Level 1 inputs. The sweep account is valued using quoted market prices with no valuation adjustments applied. Accordingly, these securities are categorized as Level 1 on the fair value hierarchy.

Concentration of Risk
Concentration of Credit Risk - Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company maintains its cash deposits at financial institutions, which cash deposits exceed insured limits. At September 30, 2025 , the majority of the Company’s cash was held by two financial institutions, and amounts on deposit were in excess of government-provided insurance limits. The Company places its cash and cash equivalents in what it believes to be high credit quality banks and money market funds and has not recognized any losses from credit risks on such accounts since inception. See Accounts Receivable, net below for further information.
Concentration of Risk, Other - The Company has a limited number of contract manufacturers for its products. At times, the Company may have only one manufacturer or supplier for its products.

Business Combination
The Company accounted for the acquisition of Sunosi (the “Acquisition”) as a business combination using the acquisition method of accounting, which requires that all identifiable assets acquired, and liabilities assumed be recorded at their estimated fair values. The excess of the fair value of purchase consideration over the fair values of identifiable assets and liabilities is recorded as goodwill. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions. Critical estimates in valuing the intangible asset include but are not limited to future expected cash flows from acquired patented technology. Management’s estimates of fair value are based upon assumptions believed to be reasonable, but are inherently uncertain and unpredictable and, as a result, actual results may differ from estimates.
As a result of the Acquisition, the Company recorded goodwill and an intangible asset.

13

Table of Contents

 

Goodwill
Goodwill is deemed to have an indefinite life and therefore not amortized. The Company tests the carrying amounts of goodwill for recoverability on an annual basis or more frequently if events or changes in circumstances indicate that the asset might be impaired. When reviewing goodwill for impairment, the Company first evaluates the qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the qualitative factors determine it is necessary to complete a goodwill impairment test, the fair value of the relevant reporting unit is determined and compared to its carrying value. If the fair value is greater than the carrying value, then the carrying value is deemed to be recoverable, and no further action is required. If the fair value estimate is less than the carrying value, goodwill is considered impaired for the amount by which the carrying amount exceeds the reporting unit’s fair value, and a charge is reported in impairment of goodwill in the Company’s consolidated statements of operations. The Company completes its annual goodwill assessment as of December 31. As of September 30, 2025 , the Company has determined that it has one reporting unit. The Company has not identified any events or changes in circumstances that indicate the existence of potential impairment of goodwill during the nine months ended September 30, 2025 . The balance of goodwill was $ 12.0 million at both September 30, 2025 and December 31, 2024.
Intangible Asset
The Company’s intangible asset is amortized using the straight-line method over its estimated period of benefit of ten years. The Company evaluates recoverability of the intangible asset periodically by considering events or changes in circumstances that may warrant revised estimates of useful lives or that indicate the asset may be impaired. The Company has not identified any events or changes in circumstances that indicate the existence of potential impairment of the intangible asset during the nine months ended September 30, 2025 .

Contingent Consideration
Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). The royalty payments due to Jazz are a high single-digit royalty on the Company’s U.S. net sales of Sunosi in the current indication and a mid-single-digit royalty on the Company’s U.S. net sales of Sunosi for future indications. Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations during such period a change is recognized. The Company estimates the fair value of the contingent consideration as of the Acquisition date and reporting periods thereafter using the probability weighted income approach and makes significant assumptions, including estimated future sales of Sunosi in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success rates, and discount rates. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded within total liabilities in the consolidated balance sheets.

Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three‑level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
Level 1—Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2—Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly.

14

Table of Contents

 

Level 3—Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. An asset’s or liability’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
The Company’s financial instruments are cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and other liabilities, contingent warrant liability, short-term and long-term debt, and current and non-current contingent consideration. The Company’s Level 1 financial instruments include cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses and other liabilities. They are considered Level 1 as the carrying values reported in the accompanying consolidated financial statements approximate their respective fair values due to their short-term maturities. The carrying value of debt on the Company’s balance sheet is estimated to approximate its fair value. The Company’s Level 3 financial instruments include contingent warrant liability and current and non-current contingent consideration due to the significant unobservable inputs required in determining their respective fair values.
The Company categorized the fair value of contingent consideration liabilities as Level 3 within the fair value hierarchy as the estimate is based on significant unobservable inputs requiring management judgment. The fair value of contingent consideration liabilities is estimated by using the probability weighted income approach using significant assumptions, including estimated future sales of Sunosi in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success and discount rates. Contingent consideration liabilities are subject to remeasurement at each prospective balance sheet date, with any changes in the fair value recorded in the consolidated statements of operations. See Note 6. Fair Value of Financial Instruments for further detail.
The Company estimated the fair value of contingent warrant liability using the Black-Scholes model based on key assumption and inputs. The Company utilized a probability assessment to estimate the likelihood of vesting for the remaining Loan Agreement (as defined below) warrants and allocated the probability of occurrence percentage to the fair values calculated, and, therefore, was considered Level 3 within the fair value hierarchy. The Company accounted for warrants anticipated to be issued in the future under the Loan Agreement as liabilities and measured them at fair value using the Black-Scholes valuation model. In the second quarter of 2025, the Company derecognized the fair value of contingent warrant liability upon extinguishment of the Hercules Loan Agreement.

Accounts Receivable, net
The Company’s accounts receivable, net arise from product sales and represent amounts due from its customers. They are generally stated at the gross sales amount, less reserves resulting from trade discounts and allowances and chargebacks. Accounts receivable typically has a standard p ayment term of 60 days or less and does not bear interest.
The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in the customers’ credit profiles. The Company estimates expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about collectability, including historical credit losses, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. The Company has not historically experienced significant credit losses. Based on its assessment, as of September 30, 2025 , the Company has no t recorded any allowances for doubtful accounts receivable. For further information about accounts receivable, see Note 3. Accounts Receivable, net .

15

Table of Contents

 

Debt Issuance Costs
Debt issuance costs consist of costs incurred in obtaining long-term financing. These costs are classified on the consolidated balance sheet as a direct deduction from the carrying amount of the related debt liability and subsequently amortized as interest expense in the consolidated statement of operations using the effective interest rate method. Costs that are directly attributable to the issuance of revolving credit facilities are capitalized and ratably amortized over the term of the revolving credit facility.
The Company evaluates amendments to its debt instruments in accordance with ASC 470-50, Debt – Modifications and Extinguishments (“ASC 470”) to determine whether the amendment should be accounted for as a modification or an extinguishment. An amendment may be considered modified when the terms of the new debt and original instrument are not “substantially different” (as defined in the debt modification guidance in ASC 470). Amendments that are considered modifications are accounted for prospectively as yield adjustments, based on the revised terms, and lender fees and costs directly incurred with third parties, to the extent material, are recorded as debt discount and amortized to interest expense using the effective interest rate method.

Inventory
The Company values its inventories at the lower of cost or estimated net realizable value. The remaining inventory associated with the Acquisition is stated at fair value due to purchase accounting. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, if they occur, are recorded within the cost of revenue.
The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired and manufactured prior to receipt of regulatory approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign.
Inventory levels are evaluated for amounts that would be sold within one year. If the level of inventory exceeds the estimated amount that would be sold after the next 12 months, the Company classifies the estimate of such inventory as non-current.

Equipment, net
Equipment consists primarily of computer equipment and is recorded at cost. Equipment is depreciated on a straight‑line basis over its estimated useful life, which the Company estimates to be three years . When equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss is included in operating expenses.

16

Table of Contents

 

Research and Development Costs
Research and development costs are expensed as incurred. Research and development expenses consist primarily of employee-related expenses, including salaries, benefits, travel and stock-based compensation expense, contract services, costs incurred to third-party service providers for conducting research, preclinical and clinical studies, laboratory supplies, product license fees, consulting and other related expenses. Research, preclinical and clinical study expenses are estimated based on services performed, pursuant to contracts with third-party research and development organizations that conduct and manage research, preclinical and clinical activities on the Company’s behalf, including discussions with internal management personnel and external service providers as to the progress or stage of completion of services and the contracted fees to be paid for such services. If the actual timing of the performance of services or the level of effort varies from the original estimates, accruals are adjusted accordingly. Payments associated with licensing agreements to acquire licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternative future use are expensed as incurred.

Advertising Costs
Advertising costs are included in selling, general and administrative expenses, and are expensed as incurred. The Company considers advertising costs as expenses related to the promotion of the Company’s commercial products. For the three and nine months ended September 30, 2025 , advertising costs were $ 41.4 million and $ 105.1 million, respectively. For the three and nine months ended September 30, 2024 , advertising costs were $ 20.7 million and $ 75.0 million, respectively.

Income Taxes
Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to the differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, operating losses, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company estimates an annual effective tax rate of 0 % for the year ending December 31, 2025 since it is projecting losses and has incurred year to date losses in all significant jurisdictions from which the Company does not benefit due to the full valuation allowance position against the Company’s deferred tax assets. The Company did no t record a tax expense or benefit for the three months ended September 30, 2025. The Company recorded a tax benefit for the nine months ended September 30, 2025 due to favorable return to provision adjustments attributable to certain foreign tax returns filed during July 2025 that was recorded as a discrete income tax benefit in the second quarter of 2025.
The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position as well as consideration of the available facts and circumstances. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. As of September 30, 2025 , the Company does not believe any material uncertain tax positions are present. In the event the Company determines that accrual of interest or penalties are necessary in the future, the amount will be presented as a component of income tax expense.

17

Table of Contents

 

Stock-Based Compensation
For stock options issued, the Company estimates the grant date fair value of each option using the Black‑Scholes option pricing model. The Black-Scholes model takes into account the expected volatility of the Company’s common stock, the risk-free interest rate, the estimated life of the option, the closing market price of the Company’s common stock and the exercise price. The estimates utilized in the Black-Scholes calculation involve inherent uncertainties and the application of management’s judgment.
For restricted stock units (“RSUs”) and performance stock units (“PSUs”), the Company issues them in the form of Company common stock. The fair market value of these awards is based on the market closing price per share on the grant date and for certain awards that are subject to a post-vesting holding period, an illiquidity discount is also applied.
The Company recognizes the grant date fair value of the stock options and RSUs over the requisite service period, which is generally the vesting term. For awards only subject to service-based vesting conditions, the Company elected to recognize stock-based compensation expense on a straight-line basis. For PSUs, the Company recognizes stock-based compensation expense when the achievement of the performance condition becomes probable. Stock-based compensation expense for PSUs with cliff-vesting terms is recognized on a straight-line basis. At the end of each reporting period, the Company reassesses the probability of achieving the performance condition and adjusts the stock-based compensation expense accordingly.
The expense related to the stock-based compensation is recorded within the same financial statement line item as the grantee’s cash compensation. The Company’s policy upon exercise of stock options, vesting of RSUs and PSUs is that shares will be issued as new shares drawing on the Company’s 2025 Long-Term Incentive Plan share pool that was adopted by the Board in April 2025 and approved by the stockholders in June 2025. In addition, the Company accounts for equity award forfeitures as they occur.

Basic and Diluted Net Loss per Common Share
Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, stock options, RSUs, PSUs, and/or common stock pursuant to the 2023 Employee Stock Purchase Plan (the “ESPP”), which would result in the issuance of incremental shares of common stock. As the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for the three and nine months ended September 30, 2025 and 2024 .

Leases
The Company determines if an arrangement is a lease at contract inception. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. When evaluating whether a contract contains a lease, the Company considers whether (1) the contract explicitly or implicitly identifies assets that are contractually defined and (2) the Company obtains substantially all of the economic benefits from the use of that underlying asset and directs how and for what purpose the asset is used during the term of the contract.
The Company’s lease agreements contain lease and non-lease components. Non-lease components primarily include payments for maintenance and utilities. The Company has applied the practical expedient to combine fixed payments for non-lease components with lease payments and account for them together as a single lease component, which increases the amount of lease assets and corresponding liabilities. Payments under the Company’s lease arrangements are primarily fixed, however, variable payments are expensed as incurred and not included in the operating lease asset and liability.

18

Table of Contents

 

Lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company uses the interest rate implicit in the contract when such rate is readily determinable and uses the Company’s incremental borrowing rate when the rate implicit in the contract is not readily determinable based upon the information available at the commencement date in determining the present value of the lease payments.
Leases are accounted for under ASC 842, Leases (“ASC 842”). The Company made an accounting policy election not to apply the recognition requirements to short-term leases. The Company recognizes the lease payments for short-term leases in the consolidated statements of operations on a straight-line basis over the lease term, and variable lease payments in the period in which the obligation for those payments is incurred. Therefore, the Company is not recognizing a lease liability or right-of-use asset for any lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to extend the term or purchase the underlying asset that the Company is reasonably certain to exercise. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company evaluates amendments to its lease arrangements in accordance with ASC 842.
The Company’s operating leases are reflected in the right-of-use operating asset; operating lease liability, current portion; and operating lease liability, long-term portion in the Company’s consolidated balance sheets. Operating lease expense is recognized on a straight-line basis over the lease term and included in selling, general and administrative expenses. Finance leases are included in the non-current inventory and other assets; accrued expenses and other current liabilities; and finance lease liability, long-term in the Company’s consolidated balance sheets. Assets under the finance leases are amortized on a straight-line basis over the lease term and included in selling, general and administrative expenses. Short-term leases, defined as leases that have a lease term of 12 months or less at the commencement date, and do not include an option to extend the term or purchase the underlying asset that the Company is reasonably certain to exercise, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease.

Recent Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid by jurisdiction, enhances disclosures in the effective tax rate reconciliation, and modifies other income tax-related disclosures. The amendments are effective for annual periods beginning after December 15, 2024. The Company adopted this guidance effective January 1, 2025 , and will provide the required disclosures in the Company’s annual report on Form 10-K for the year ended December 31, 2025. The adoption of this guidance is not expected to have a material impact on the consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included on the face of the income statement. The guidance is effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the effect of adopting this guidance on its consolidated financial statements.

Note 3. Accounts Receivable, net
Accounts receivable, net consisted of the following:

 

 

September 30,
2025

 

 

December 31,
2024

 

Trade receivables

 

$

215,848

 

 

$

155,505

 

Less: Reserves for variable consideration

 

 

( 19,341

)

 

 

( 13,504

)

Accounts receivable, net

 

$

196,507

 

 

$

142,001

 

 

19

Table of Contents

 

Note 4. Inventory
Inventory consisted of the following:

 

 

September 30,
2025

 

 

December 31,
2024

 

Raw materials

 

$

12,436

 

 

$

9,541

 

Work in process

 

 

12,851

 

 

 

7,723

 

Finished goods

 

 

10,349

 

 

 

8,986

 

Total

 

$

35,636

 

 

$

26,250

 

There were no material inventory reserves or write downs of any excess and obsolete inventory as of September 30, 2025. Non-current inventory, which consists of raw materials and work in process inventory, is included in non-current inventory and other assets on the accompanying consolidated balance sheets. Non-current inventory is estimated to be consumed beyond the next 12 months.
The following table summarizes the balance sheet classification of the Company’s inventory for each of the periods indicated:

 

 

September 30,
2025

 

 

December 31,
2024

 

Balance sheet classification

 

 

 

 

 

 

Inventories, net

 

$

23,774

 

 

$

15,732

 

Non-current inventory and other assets

 

 

11,862

 

 

 

10,518

 

Total

 

$

35,636

 

 

$

26,250

 

 
Note 5. Intangible Asset
The following table provides the Company’s carrying amount of the intangible asset for each of the periods indicated.

 

 

Gross carrying amount

 

 

Accumulated amortization

 

 

Net carrying amount

 

 

Remaining weighted-average useful life

Balance at December 31, 2024

 

 

 

 

 

 

 

 

 

 

 

Finite-lived intangible asset

 

$

63,800

 

 

$

16,906

 

 

$

46,894

 

 

8 -years

Balance at September 30, 2025

 

 

 

 

 

 

 

 

 

 

 

Finite-lived intangible asset

 

$

63,800

 

 

$

21,674

 

 

$

42,126

 

 

7 -years

Based on the finite-lived intangible asset recorded as of September 30, 2025, and assuming the underlying asset will not be impaired and that the Company will not change the expected life of the asset, future amortization expense over the next five years and periods thereafter are estimated to be as follows:

 

 

Estimated amortization expense

 

2025

 

$

1,607

 

2026

 

 

6,375

 

2027

 

 

6,375

 

2028

 

 

6,392

 

2029

 

 

6,375

 

Thereafter

 

 

15,002

 

Total

 

$

42,126

 

 

20

Table of Contents

 

Note 6. Fair Value of Financial Instruments
In connection with the Acquisition, the Company pays royalty on U.S. net sales of Sunosi to Jazz. The discounted cash flow method used to value this contingent consideration includes inputs of not readily observable market data, which are Level 3 inputs. The fair value of the contingent consideration is reflected as current accrued contingent consideration of $ 9.7 million and non-current contingent consideration liability of $ 89.9 million in the consolidated balance sheet as of September 30, 2025.
The fair value of financial instruments measured on a recurring basis is as follows:

 

 

September 30, 2025

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents - money market funds

 

$

240,099

 

 

$

—

 

 

$

—

 

 

$

240,099

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration

 

$

—

 

 

$

—

 

 

$

99,565

 

 

$

99,565

 

 

 

 

December 31, 2024

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents - money market funds

 

$

244,097

 

 

$

—

 

 

$

—

 

 

$

244,097

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration

 

$

—

 

 

$

—

 

 

$

99,965

 

 

$

99,965

 

Contingent Consideration Liabilities
The fair value of the contingent consideration liabilities is marked-to-market at each reporting period and was remeasured at September 30, 2025. Changes in fair value of the contingent consideration liabilities as of September 30, 2025 are as follows:

 

 

Contingent consideration

 

Balance at December 31, 2024

 

$

99,965

 

Adjustment to fair value

 

 

6,595

 

Payments

 

 

( 6,995

)

Balance at September 30, 2025 (Level 3)

 

$

99,565

 

The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs:

 

 

 

 

 

 

As of September 30, 2025

 

As of December 31, 2024

 

 

Valuation methodology

 

Significant unobservable input

 

Weighted average (range, if applicable)

 

Weighted average (range, if applicable)

Contingent consideration

 

Probability weighted income approach

 

Discount rate

 

12.9 %

 

12.0 %

 

 

 

 

Revenue discount rate

 

17.7 % - 20.7 %

 

17.6 % - 20.6 %

 

21

Table of Contents

 

The Company’s fair value measurement of contingent consideration liabilities has been classified as Level 3 as its valuation requires substantial judgment and estimation of factors which requires use of unobservable inputs. The fair value of contingent consideration liabilities are estimated by using the probability weighted income approach using significant assumptions including estimated future sales of Sunosi in current and future indications, timing of regulatory and commercial milestone achievements, probability of technical and regulatory success rates, and discount rates. If significant changes are made to one or more of these assumptions, the estimated fair value of contingent consideration liabilities may result in a significantly higher or lower fair value measurement.

Note 7. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:

 

 

September 30,
2025

 

 

December 31,
2024

 

Accrued research and development

 

$

12,657

 

 

$

14,431

 

Accrued compensation

 

 

27,798

 

 

 

28,225

 

Accrued selling, general, and administrative

 

 

36,163

 

 

 

17,498

 

Accrued sales discounts, rebates, and allowances

 

 

139,471

 

 

 

73,952

 

Accrued royalties

 

 

7,001

 

 

 

9,958

 

Accrued interest

 

 

45

 

 

 

1,542

 

Accrued taxes

 

 

—

 

 

 

960

 

Finance lease liability, current

 

 

2,497

 

 

 

1,421

 

Total

 

$

225,632

 

 

$

147,987

 

 
Note 8. Loan and Security Agreement
Blackstone Alternative Credit Advisors LP and Blackstone Life Sciences Advisors L.L.C.
For the purposes of this Note 8, capitalized terms used but not otherwise defined herein shall have the meanings assigned to them in the Blackstone Loan Agreement (as defined below).
On May 8, 2025 (the “Closing Date”), the Company entered into a loan agreement (the “Blackstone Loan Agreement”) with Blackstone Alternative Credit Advisors LP and Blackstone Life Sciences Advisors L.L.C. (collectively, the “Blackstone Representative” and referred to herein as “Blackstone”), certain subsidiaries of the Company party thereto as guarantors, Wilmington Trust, National Association, as agent, and the lenders from time to time party thereto (collectively, the “Lenders”). The Blackstone Loan Agreement provides for loans in an aggregate principal amount of up to $ 570.0 million, consisting of (i) a first lien senior secured term loan in an aggregate principal amount of $ 120.0 million funded to the Company on the Closing Date, (ii) a $ 180.0 million senior secured term loan available to the Company at its option, of which $ 90.0 million is available until May 31, 2026, and the remaining $ 90.0 million is available until May 31, 2027 (the “Term Loans”), and (iii) a super senior revolving credit facility in an aggregate principal amount of up to $ 70.0 million available at the Company’s option (the “Revolver” and, together with the Term Loans, the “Loans”). The Blackstone Loan Agreement also permits the Company, subject to the consent of the Lenders, to request incremental term loans in an aggregate principal amount of up to $ 200.0 million at any time and on the same terms as the initial Term Loans, except that any call protection will be determined at the time the incremental term loans are incurred. The proceeds of the Term Loans were used, together with cash on hand, to repay in full the Company’s obligations under the Hercules Loan Agreement (as defined below). The improved financial terms and anticipated use of the Loans are expected to result in a significant reduction in interest expense. As of September 30, 2025 , there were $ 120.0 million and $ 70.0 million of outstanding principal amounts under the Term Loans and Revolver facilities, respectively. The outstanding balance under the Revolver was classified as short-term based on the Company’s intent and ability to repay this amount in the next twelve months, and included in short-term borrowings on the accompanying consolidated balance sheets. In October 2025, the Company repaid the entire outstanding balance as of September 30, 2025 under the Revolver.

22

Table of Contents

 

The Term Loans bear interest at a rate equal to the Term SOFR (“Secured Overnight Financing Rate”) plus a margin of 4.75 %. The effective interest rate on the Term Loans was 9.58 % for the nine months ended September 30, 2025 . The Revolver bears interest at SOFR plus a margin of 4.00 %. If an Event of Default occurs and is continuing, all amounts outstanding under the Blackstone Loan Agreement will bear an additional 2.00 % interest. The weighted-average interest rate on the Revolver was 8.00 % as of September 30, 2025. The Loans mature and the principal amount (including any interest and fees) must be repaid on the date that is five years from the Closing Date. Fees and costs that were directly attributable to the Revolver have been capitalized as deferred assets and will be ratably expensed over the life of the Revolver. Deferred assets are included in non-current inventory and other assets on the accompanying consolidated balance sheets. As of September 30, 2025 , the remaining unamortized balance of deferred assets was $ 1.0 million.
The Loans are subject to mandatory prepayment provisions that may require prepayment upon a change of control, the incurrence of certain additional indebtedness, certain asset sales, or an event of loss, subject to certain conditions set forth in the Blackstone Loan Agreement. The Company may prepay the Loans in whole at its option at any time, subject to certain yield protection premiums. The obligations under the Blackstone Loan Agreement are guaranteed by the Company’s subsidiaries party thereto as guarantors and are secured by a first lien security interest in certain assets of the Company and the guarantors.
The Blackstone Loan Agreement contains customary representations and warranties, affirmative and negative covenants, and events of default applicable to the Company and the guarantors. The Blackstone Loan Agreement also contains a minimum liquidity covenant of $ 30.0 million, tested quarterly. If an event of default occurs and is continuing, the Lenders may declare all amounts outstanding under the Blackstone Loan Agreement to be immediately due and payable.
Concurrent with the closing of the Blackstone Loan Agreement, Blackstone purchased $ 15.0 million of the Company’s common stock at a purchase price of $ 107.14 per share in a private placement transaction. The purchase agreement for the private placement contains customary representations, warranties, and covenants, and includes a lock-up period that generally prohibits, without the prior written consent of the Company, the sale, transfer, pledge, or other disposition of the securities through the period ending 120 days from the Closing Date.
In connection with the Blackstone Loan Agreement, Antecip consented to the collateral assignment of one of the license agreements, among other things, under a direct agreement among the Company, Antecip, a related party, and Blackstone.
Hercules Capital, Inc.
In September 2020, the Company entered into a Loan and Security Agreement for a term loan with Hercules Capital, Inc., a Maryland corporation (“Hercules”), in its capacity as administrative agent and collateral agent and as a lender, and the other financial institutions that from time to time act as lenders (the “Hercules Loan Agreement”, as amended).
On May 8, 2025, the Company repaid in full its obligations under the Hercules Loan Agreement using proceeds from the Blackstone Loan Agreement. Upon repayment, the Company recorded a loss on debt extinguishment of approximately $ 10.4 million in the Company’s consolidated statement of operations. As of September 30, 2025 , there are no outstanding obligations under the Hercules Loan Agreement.

23

Table of Contents

 

Loan Interest Expense and Amortization
Long-term debt and unamortized debt discount balances are as follows:

 

 

September 30,
2025

 

 

December 31,
2024

 

Total outstanding debt, long-term

 

$

120,000

 

 

$

180,000

 

Add: accreted final payment fee

 

 

—

 

 

 

4,085

 

Less: unamortized debt discount, long-term

 

 

( 2,358

)

 

 

( 3,375

)

Loan payable, long-term

 

$

117,642

 

 

$

180,710

 

The book value of debt approximates its fair value given its variable interest rate.
Interest expense, amortization of the final payment fee, and amortization of the debt discount related to the issuance costs and warrants for the Company’s debt are as follows:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Interest expense

 

$

3,056

 

 

$

4,892

 

 

$

11,173

 

 

$

14,630

 

Amortization of final payment fee

 

 

—

 

 

 

375

 

 

 

527

 

 

 

1,085

 

Amortization of debt discount related issuance costs and warrants

 

 

158

 

 

 

297

 

 

 

615

 

 

 

847

 

Scheduled principal payments on outstanding debt, long-term, as of September 30, 2025, are as follows:

2025

 

$

—

 

2026

 

 

—

 

2027

 

 

—

 

2028

 

 

—

 

2029

 

 

—

 

Thereafter

 

 

120,000

 

Total principal payments outstanding

 

$

120,000

 

 
Note 9. Commitments and Contingencies
Leases
In February 2023, the Company entered into a sublease agreement (“Initial Sublease”) for the previous office space located at One World Trade Center.
In January 2025 , the Company entered into an amended sublease agreement (the “First Amendment”) to terminate the existing space in its corporate office and commence occupancy of different space within the same building. The First Amendment was treated as a lease modification to the Initial Sublease which resulted in the recognition of a gain on modification of $ 2.3 million which is included in selling, general and administrative expenses. The Company also recorded a right-of-use asset and corresponding lease liability of $ 23.9 million during the first quarter of fiscal year 2025. Based on the Company’s past experience and current expectations for administrative office needs, the Company determined the lease term to be approximately six years . As of September 30, 2025 , the remaining lease term for the Company’s operating lease was 5.5 years with the discount rate of 7.12 %. The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment.

24

Table of Contents

 

The Company entered into a fleet lease program beginning the first quarter of 2024. The lease agreement includes an initial 12 -month noncancelable period with monthly renewal options thereafter. Lease terms range from approximately 40 to 50 months and are classified as finance leases. During the nine months ended September 30, 2025 , the Company recognized a right-of-use asset and lease liability, both, of $ 4.4 million in connection to this lease. As of September 30, 2025 , right-of-use asset and lease liability related to the finance lease were $ 7.1 million and $ 7.2 million, respectively, and the weighted average remaining lease term was 3.0 years, with a weighted average discount rate of 9.6 %.
Lease expenses recognized were as follows:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Operating lease expense

 

$

1,261

 

 

$

583

 

 

$

3,479

 

 

$

1,749

 

Finance lease expense:

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of right-of-use assets

 

 

684

 

 

 

324

 

 

 

1,633

 

 

 

697

 

Interest on lease liabilities

 

 

160

 

 

 

101

 

 

 

403

 

 

 

222

 

Future minimum lease payments of the Company’s leases as of September 30, 2025 were as follows:

 

 

Operating lease

 

 

Finance lease

 

2025

 

$

476

 

 

$

783

 

2026

 

 

2,178

 

 

 

3,007

 

2027

 

 

4,791

 

 

 

2,487

 

2028

 

 

4,807

 

 

 

1,644

 

2029

 

 

11,284

 

 

 

262

 

Thereafter

 

 

6,317

 

 

 

—

 

Total lease payments

 

 

29,853

 

 

 

8,183

 

Less: imputed interest

 

 

( 6,076

)

 

 

( 1,006

)

Present value of lease liabilities

 

$

23,777

 

 

$

7,177

 

 
Note 10. Stockholders’ Equity
Public Offerings
At-the-Market Offerings
In March 2022, the Company entered into a sales agreement (the “March 2022 Sales Agreement”) with Leerink Partners LLC (“Leerink”) and filed a prospectus supplement. The March 2022 Sales Agreement supersedes the sales agreement, dated December 5, 2019, by and between the Company and Leerink. The Company exhausted sales of shares of the Company’s common stock under its prior at-the-market offering program.
In December 2022, in connection with the automatic shelf registration statement (the “2022 Shelf Registration Statement”), the Company filed a new sales agreement prospectus to replace the prior prospectus supplement filed in August 2022 associated with the expired automatic shelf registration statement (the “2019 Shelf Registration Statement”), which the Company filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 5, 2019. The new sales agreement prospectus covered the issuance and sale by the Company of up to the same $ 250 million of the Company’s common stock that may be issued and sold from time to time through Leerink, as the Company’s sales agent, under the March 2022 Sales Agreement .

25

Table of Contents

 

Under the March 2022 Sales Agreement, for the three months ended September 30, 2025 , the Company received approximately $ 9.9 million in gross proceeds through the sale of 88,512 shares, of which net proceeds were approximately $ 9.7 million. For the nine months ended September 30, 2025 , the Company received approximately $ 47.2 million in gross proceeds through the sale of 411,482 shares, of which net proceeds were approximately $ 46.3 million under the March 2022 Sales Agreement.
June 2023 Public Offering
In June 2023, the Company completed an underwritten public offering of its common stock (the “June 2023 Public Offering”). The Company sold 3.0 million shares of its common stock at a public offering price of $ 75.00 per share. The net proceeds were $ 211.3 million, net of underwriting discounts and commissions of $ 13.5 million and other offering costs of $ 0.2 million. Additionally, in connection with this public offering, in July 2023, the underwriters fully exercised their option to purchase 450,000 additional shares of the Company’s common stock at a public offering price of $ 75.00 per share. The net proceeds from the exercise of the option were $ 31.7 million, net of underwriting discounts and commissions of $ 2.0 million and other minimal offering costs.
Blackstone Securities Purchase Agreement
In May 2025, the Company entered into a securities purchase agreement (the “SPA”) with Blackstone or its affiliates for the private placement (the “Private Placement”) of an aggregate of 140,000 shares of the Company’s common stock, at a purchase price of $ 107.14 per share. Gross proceeds from the Private Placement were approximately $ 15.0 million. The closing of the Private Placement occurred contemporaneously with the closing of the Blackstone Loan Agreement.
Shelf Registration Statement
Contemporaneously herewith, the Company filed an automatic shelf registration statement (the “2025 Shelf Registration Statement”) with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units. It became effective upon filing with the SEC and is currently the Company’s only active shelf registration.
Under SEC rules, the 2025 Shelf Registration Statement allows for the potential future offer and sale by the Company, from time to time, in one or more public offerings of an indeterminate amount of the Company’s common stock, preferred stock, debt securities, and units at indeterminate prices. At the time any of the securities covered by the 2025 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.
Equity Incentive Plan
In November 2015, the 2015 Omnibus Incentive Compensation Plan (the “2015 Plan”) was adopted by the Company’s stockholders. In April 2025, the Company’s Long-Term Incentive Plan (“2025 Plan”) was adopted by the Board and approved by the stockholders in June 2025. All future equity awards will be made from the 2025 Plan and the Company does not intend to grant any future equity awards from the 2015 Plan. As of September 30, 2025, there were 2,592,462 shares available for future grant under the 2025 Plan.

26

Table of Contents

 

Stock Options
The following table sets forth stock option activity as of September 30, 2025:

 

 

Number
of shares

 

 

Weighted
average
exercise price

 

 

Weighted
average
contractual
term (years)

 

 

Aggregate
intrinsic
value

 

Outstanding at December 31, 2024

 

 

8,439,121

 

 

$

46.72

 

 

 

 

 

 

 

Granted

 

 

361,938

 

 

 

123.86

 

 

 

 

 

 

 

Exercised

 

 

( 938,068

)

 

 

43.17

 

 

 

 

 

 

 

Forfeited/Canceled

 

 

( 275,373

)

 

 

72.00

 

 

 

 

 

 

 

Outstanding at September 30, 2025

 

 

7,587,618

 

 

$

49.93

 

 

 

5.9

 

 

$

546,116

 

Vested and expected to vest at September 30, 2025

 

 

7,587,618

 

 

$

49.93

 

 

 

5.9

 

 

$

546,116

 

Exercisable at September 30, 2025

 

 

5,552,310

 

 

$

39.63

 

 

 

5.0

 

 

$

454,782

 

The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model. The expected term of the Company’s stock options has been determined utilizing the “simplified method” as described in the SEC’s Staff Accounting Bulletin No. 107 relating to stock-based compensation. The simplified method was chosen because the Company has limited historical option exercise experience due to its short operating history. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for a period approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does no t expect to pay any cash dividends in the foreseeable future. In prior years, expected volatility was based on historical volatilities of similar entities within the Company’s industry which were commensurate with the Company’s expected term assumption. Currently, expected volatility is based on historical volatility information of the Company’s common stock since the Company’s initial public offering in 2015.
The weighted average grant date fair value of options granted was $ 88.37 per option for the nine months ended September 30, 2025. As of September 30, 2025 , there was $ 112.6 million of total unrecognized compensation cost related to unvested stock options which is expected to be recognized over a weighted average period of 2.1 years.
Restricted Stock Units
The fair value of the RSUs is recognized as an expense ratably over the vesting period of four years . As of September 30, 2025 , total compensation cost not yet recognized related to nonvested RSUs was $ 73.4 million, which is expected to be recognized over a weighted-average period of 2.6 years. The intrinsic value of RSUs lapsed during the nine months ended September 30, 2025 was $ 17.2 million.
The following table sets forth the RSU activity for the nine months ended September 30, 2025:

 

 

Number
of shares

 

 

Weighted
average
grant date
fair value

 

Nonvested at December 31, 2024

 

 

906,944

 

 

$

59.48

 

Granted

 

 

468,455

 

 

 

120.84

 

Vested

 

 

( 295,835

)

 

 

51.71

 

Forfeited

 

 

( 72,580

)

 

 

91.81

 

Nonvested at September 30, 2025

 

 

1,006,984

 

 

$

87.98

 

 

27

Table of Contents

 

Performance Stock Units
In February 2025, the Company granted PSUs to the executive officers. Vesting of the PSUs is subject to achievement of specified performance goals, which include achieving revenue, clinical, and regulatory targets. The actual number of common shares that would ultimately be issued is calculated by multiplying the number of PSUs granted by a payout multiplier ranging from 0 to 2 . Achievement of the performance goals will ultimately be determined by the Compensation Committee or the Board at the end of the vesting term, which is approximately 3 years from the grant date. As of September 30, 2025 , total compensation cost not yet recognized related to nonvested PSUs was $ 4.9 million, which is expected to be recognized over a weighted-average period of 2.5 years.
The following table sets forth the PSU activity for the nine months ended September 30, 2025:

 

 

Number
of shares

 

 

Weighted
average
grant date
fair value

 

Nonvested at December 31, 2024

 

 

—

 

 

$

—

 

Granted

 

 

64,281

 

 

 

94.39

 

Vested

 

 

—

 

 

 

—

 

Forfeited

 

 

—

 

 

 

—

 

Nonvested at September 30, 2025

 

 

64,281

 

 

$

94.39

 

Employee Stock Purchase Plan
The ESPP allows eligible employees to purchase shares of the Company’s common stock. The purchase price is equal to 85 % of the lower of the closing price of the Company’s common stock on (1) the first day of the offering period or (2) the last day of the offering period. The ESPP has consecutive offering periods that begin on or about June 1st of each year with a duration of 12 months. The Company commenced the second offering period pursuant to the ESPP on June 1, 2024, and such offering ended on May 31, 2025.
During the nine months ended September 30, 2025 , 59,607 common shares have been purchased and issued pursuant to the ESPP, and $ 0.7 million and $ 1.5 million of expense was recorded for the three and nine months ended September 30, 2025.
Stock-based Compensation Expense
Stock-based compensation expense recognized was as follows:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Research and development

 

$

6,807

 

 

$

5,868

 

 

$

20,207

 

 

$

15,508

 

Selling, general and administrative

 

 

16,296

 

 

 

15,792

 

 

 

50,815

 

 

 

47,724

 

Total

 

$

23,103

 

 

$

21,660

 

 

$

71,022

 

 

$

63,232

 

Stock-based compensation expense capitalized into inventory totaled $ 0.3 million and $ 1.0 million for the three and nine months ended September 30, 2025 , respectively, and $ 0.3 million and $ 1.0 million for the three and nine months ended September 30, 2024 , respectively. Capitalized stock-based compensation is recognized as an expense in cost of product sales when the related product is sold or in selling, general and administrative expense when the related product is dispensed as a physician sample.

28

Table of Contents

 

 
 
Note 11. Warrants
The following table summarizes warrant activity for the nine months ended September 30, 2025:

 

 

Warrants

 

 

Weighted average
exercise price

 

Outstanding at December 31, 2024

 

 

79,220

 

 

$

56.80

 

Issued

 

 

—

 

 

 

—

 

Exercised

 

 

—

 

 

 

—

 

Outstanding at September 30, 2025

 

 

79,220

 

 

$

56.80

 

Outstanding Warrants
In connection with the entry into the Third Amendment to the Hercules Loan Agreement, Hercules received warrants to purchase an aggregate of 18,724 shares of the Company’s common stock at an exercise price of $ 55.01 per share, and in connection with the draw down of the Tranche 1C Advance, Hercules received warrants to purchase 9,700 shares of the Company’s common stock at an exercise price of $ 77.31 per share (collectively, the “2023 warrants”). In connection with the entry into the Second Amendment, Hercules received warrants to purchase an aggregate of 35,255 shares of the Company’s common stock at an exercise price of $ 31.91 per share (the “2022 warrants”), and in connection with the first advance of the 2020 Term Loan, Hercules received warrants to purchase an aggregate of 15,541 shares of the Company’s common stock at an exercise price of $ 80.43 per share (the “2020 warrants”).
The 2023 warrants, 2022 warrants and 2020 warrants were priced using the volume weighted average price of the Company’s common stock over the ten -day trading period immediately preceding the initial closing, subject to certain limited adjustments as specified in the warrant. The warrants are exercisable for seven years from the date of issuance. The warrants were classified as a component of stockholders’ equity. The relative fair value of the warrants of approximately $ 1.6 million for the 2023 warrants, $ 0.8 million for the 2022 warrants and $ 0.9 million for the 2020 warrants at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. Upon full repayment of the Company’s obligations under the Hercules Loan Agreement, no additional warrants are issuable under the Hercules Loan Agreement.

Note 12. Net Loss per Common Share
The following table sets forth the computation of basic and diluted net loss per common share:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Basic and diluted net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

( 47,229

)

 

$

( 64,602

)

 

$

( 154,615

)

 

$

( 212,304

)

Weighted average common shares outstanding—basic and diluted

 

 

50,021,851

 

 

 

48,140,519

 

 

 

49,449,220

 

 

 

47,703,508

 

Net loss per common share—basic and diluted

 

$

( 0.94

)

 

$

( 1.34

)

 

$

( 3.13

)

 

$

( 4.45

)

 

29

Table of Contents

 

The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding, as they would be anti-dilutive:

 

 

September 30,

 

 

 

2025

 

 

2024

 

Stock options

 

 

7,587,618

 

 

 

8,453,826

 

Restricted stock units

 

 

1,495,986

 

 

 

899,277

 

Performance stock units

 

 

64,281

 

 

 

—

 

Warrants

 

 

79,220

 

 

 

79,220

 

ESPP

 

 

83,477

 

 

 

69,761

 

Total

 

 

9,310,582

 

 

 

9,502,084

 

 
Note 13. Revenues
The Company sells Auvelity, Sunosi, and Symbravo in the United States through the Distributors. The Company also sells Sunosi to Distributors in Canada and on a product supply basis to Pharmanovia. Sunosi is subsequently sold by Pharmanovia in certain ex-U.S. markets. For the nine months ended September 30, 2025 , the Company’s three largest customers represented approximately 34 %, 30 %, and 26 % of the Company’s gross product sales.
Royalty revenue is related to sales of Sunosi by Pharmanovia in certain ex-U.S. markets.
The following table presents a summary of total revenues by product:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Product sales, net

 

 

 

 

 

 

 

 

 

 

 

 

Auvelity

 

$

136,102

 

 

$

80,378

 

 

$

351,975

 

 

$

198,798

 

Sunosi

 

 

31,611

 

 

 

23,358

 

 

 

84,645

 

 

 

65,554

 

Symbravo

 

 

2,071

 

 

 

—

 

 

 

2,481

 

 

 

—

 

Total product sales, net

 

 

169,784

 

 

 

103,736

 

 

 

439,101

 

 

 

264,352

 

Sunosi royalty revenue

 

 

1,208

 

 

 

1,026

 

 

 

3,396

 

 

 

2,575

 

Total revenues

 

$

170,992

 

 

$

104,762

 

 

$

442,497

 

 

$

266,927

 

The following table presents a summary of total revenues by geographic location:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Product sales, net

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

$

169,176

 

 

$

102,810

 

 

$

435,035

 

 

$

261,525

 

Outside of the United States

 

 

608

 

 

 

926

 

 

 

4,066

 

 

 

2,827

 

Total product sales, net

 

 

169,784

 

 

 

103,736

 

 

 

439,101

 

 

 

264,352

 

Royalty revenue

 

 

 

 

 

 

 

 

 

 

 

 

Outside of the United States

 

 

1,208

 

 

 

1,026

 

 

 

3,396

 

 

 

2,575

 

Total revenues

 

$

170,992

 

 

$

104,762

 

 

$

442,497

 

 

$

266,927

 

For the nine months ended September 30, 2025 , product sales, net includes adjustments for provisions for product sales made in 2024 resulting from changes in estimates of $ 0.9 million for Auvelity and $ 0.8 million for Sunosi. For the nine months ended September 30, 2024 , product sales, net includes adjustments for provisions for product sales made in 2023 resulting from changes in estimates of $ 1.0 million for Auvelity and $ 0.6 million for Sunosi.

30

Table of Contents

 

Note 14. License Agreements
License Agreement with Pharmanovia
In February 2023, Axsome Malta, a Malta limited company and a wholly-owned subsidiary of the Company, entered into an exclusive license agreement with Pharmanovia (the “Pharmanovia License Agreement”) to commercialize and further develop Sunosi in Europe and certain countries in the Middle East and North Africa (the “Territory”). Under the terms of the Pharmanovia License Agreement, the Company retains its existing interest in Sunosi intellectual property and licenses those rights in the Territory to Pharmanovia. Pharmanovia is solely responsible for the clinical development and commercialization of Sunosi in the Territory. The Company will continue to manufacture Sunosi and provide product supply to Pharmanovia for an indefinite period of time, and the Company will recognize revenue as a component of product sales, net when product is supplied to Pharmanovia.
In consideration for entering the Pharmanovia License Agreement, the Company received a non-refundable upfront payment of € 62.0 million ($ 65.7 million). The Company also will receive a royalty percentage in the mid-twenties on Sunosi net sales in the Territory and is eligible to receive sales-based milestone payments totaling up to € 94.5 million.
The Company evaluated the Pharmanovia License Agreement under ASC 606 and concluded that Pharmanovia represents a customer in the transaction. The initial transaction price consisted of the non-refundable upfront payment, which was recognized as License Revenue in the first quarter of 2023 upon transfer of the license to Pharmanovia, as the requirement for revenue recognition under ASC 606 were met. The remaining forms of consideration are variable because they are dependent on the achievement of sales-based or other milestones. The Company evaluated the constraint on variable consideration and concluded that the milestone payments are dependent on regulatory approvals and actions of third parties, and thus are highly susceptible to factors outside the Company’s influence. Therefore, at contract inception, the milestones are not included in the transaction price as it is not probable that a significant reversal of revenue would not occur. Sales-based milestones will be recognized as revenue in the period when the related sales threshold is met. All other development or regulatory milestones will be recognized as revenue immediately in the period the underlying milestone is achieved. Any consideration related to sales-based royalties will be recognized when the related sales occur. The Company recognized royalty revenue of $ 1.2 million and $ 1.0 million for the three months ended September 30, 2025 and 2024, respectively, and $ 3.4 million and $ 2.6 million for the nine months ended September 30, 2025 and 2024 , respectively, related to Pharmanovia’s sales of Sunosi. No other development or sales-based milestones were recognized during the nine months ended September 30, 2025 and 2024.
Exclusive License Agreement with Pfizer
In January 2020, the Company entered into an exclusive license agreement with Pfizer Inc. (“Pfizer”) for Pfizer’s clinical and nonclinical data, and intellectual property for reboxetine, the active pharmaceutical ingredient in AXS-12 which the Company is developing for the treatment of narcolepsy. The agreement also provides the Company exclusive rights to develop and commercialize esreboxetine, a new late-stage product candidate referred to as AXS-14, in the U.S. for the treatment of fibromyalgia.
Under the terms of the agreement, Pfizer received 82,019 shares of the Company’s common stock having a stated value of $ 8.0 million, based on the average closing price of the Company’s common stock for the ten prior trading days of $ 97.54 , in consideration for the license and rights and also received an upfront cash payment of $ 3.0 million. The Company determined that the fair value of each share of common stock granted to Pfizer on the closing date of January 9, 2020 was $ 87.24 , based on the closing price of the Company’s stock on that date. As a result, the fair value of the stock issued was $ 7.2 million and, therefore, the total research and development expense recognized was $ 10.2 million related to the Pfizer license agreement during the year ended December 31, 2020.
Pfizer can also receive up to $ 323 million in regulatory and sales milestones, and tiered mid-single to low double-digit royalties on future sales related to the licensed products. Pfizer will also have a right of first negotiation on any potential future strategic transactions involving AXS-12 and AXS-14. During the three and nine months ended September 30, 2025 and 2024 , no milestone payments or royalties were paid to Pfizer by the Company.

31

Table of Contents

 

Exclusive License Agreements with Antecip
In 2012, the Company entered into three exclusive license agreements with Antecip, an entity owned by the Company’s Chief Executive Officer and Chairman of the Board, Herriot Tabuteau, M.D., in which the Company was granted exclusive licenses to develop, manufacture and commercialize Antecip’s patents and applications related to the development of AXS-05 (now marketed as Auvelity) and two product candidates no longer under active development, anywhere in the world for human therapeutic, veterinary, and diagnostic use. Pursuant to the agreements, the Company is required to use commercially reasonable efforts to develop, obtain regulatory approval for and commercialize these product candidates. Under the terms of the agreements, the Company is required to pay to Antecip a royalty equal to 3.0 % for AXS-05 (and 1.5 % or 4.5 % for the other two product candidates no longer under active development), of net sales of products containing the licensed technology by the Company, its affiliates, or permitted sublicensees. These royalty payments are subject to reduction by an amount up to 50.0 % of any required payments to third parties. Unless earlier terminated by a party for cause or by the Company for convenience, the agreements shall remain in effect on a product-by-product and country-by-country basis until the later to occur of (i) the applicable product is no longer covered by a valid claim in that country or (ii) 10 years from the first commercial sale of the applicable product in that country. Upon expiration of the agreements with respect to a product in a country, the Company’s license grant for that product in that country will become a fully paid-up, royalty-free, perpetual non-exclusive license. If Antecip terminates any of the agreements for cause, or if the Company exercises its right to terminate any of the agreements for convenience, the rights granted to the Company under such terminated agreement will revert to Antecip. The Company began recording royalty payments to Antecip along with the initiation of sales of Auvelity (the components of which are referred to as “AXS-05”) in the fourth quarter of 2022. For the nine months ended September 30, 2025 and 2024 , the Company recorded royalty expense of $ 10.6 million and $ 6.0 million, respectively, for royalty due to Antecip, which is equal to 3.0 % of net sales of Auvelity. This is considered to be a related party transaction.
In connection with the Blackstone Loan Agreement, Antecip consented to the collateral assignment of one of the license agreements, among other things, under a direct agreement among the Company, Antecip and Blackstone.

Note 15. Royalty Agreements
On March 25, 2022, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Jazz, pursuant to which the Company was to acquire commercial and development rights with respect to Sunosi from Jazz in certain U.S. and ex-U.S. markets. The Acquisition occurred in two separate closings. The sale and purchase of specified initial assets contemplated by the Purchase Agreement occurred on May 9, 2022 (the “Initial Closing”), following the satisfaction or waiver of the closing conditions under the Purchase Agreement. The sale and purchase of specified ex-U.S. assets contemplated by the Purchase Agreement occurred on November 14, 2022, following the satisfaction or waiver of the closing conditions under the Purchase Agreement (the “Final Closing”). The Company accounted for the Initial Closing as a business combination using the acquisition method of accounting, and the Company accounted for the Final Closing as an asset acquisition.
Pursuant to the Purchase Agreement, the Company agreed to make non-refundable, non-creditable royalty payments to Jazz equal to a (A) high single-digit royalty for any current indication, or (B) mid-single-digit royalty for any future indication of net sales in the U.S. Territory made during the applicable royalty term. There are no royalty payments due to Jazz for net sales outside of the U.S. Territory.
At the Initial Closing, the Company assumed all of the commitments of Jazz to SK and Aerial. SK is the originator of Sunosi and retains rights in 12 Asian markets, including China, Korea and Japan. In 2014, Jazz acquired from Aerial worldwide rights to Sunosi excluding those Asian markets stated previously. The assumed commitments to SK and Aerial include single-digit tiered royalties based on the Company’s sales of Sunosi, and additionally, the Company is committed to pay up to $ 165.0 million based on revenue milestones and $ 1.0 million based on development milestones.

32

Table of Contents

 

Note 16. Income Taxes
The table below presents the Company’s loss before income taxes and effective tax rates for all periods presented:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Loss before income taxes

 

$

( 47,229

)

 

$

( 64,602

)

 

$

( 155,575

)

 

$

( 212,304

)

Income tax benefit

 

 

—

 

 

 

—

 

 

 

960

 

 

 

—

 

Effective tax rate

 

 

—

%

 

 

—

%

 

 

( 0.6

)%

 

 

—

%

The Company is subject to income taxes in the United States and foreign jurisdictions in which the Company does business. These foreign jurisdictions have statutory tax rates different from those in the United States. Accordingly, the Company’s effective tax rates will vary depending on the relative proportion of foreign to United States income, the utilization of net operating loss and tax credit carry forwards, changes in geographic mix of income and expense, and changes in management’s assessment of matters such as the ability to realize deferred tax assets and changes in tax laws. The Company regularly assesses the likelihood of adverse outcomes resulting from the examination of the Company’s tax returns by the Internal Revenue Service (the “IRS”) and other tax authorities to determine the adequacy of its income tax reserves and expense. Should actual events or results differ from the Company’s current expectations, charges or credits to its income tax expense may become necessary.
The Company did no t record a tax expense or benefit for the three months ended September 30, 2025. The Company recorded a tax benefit for the nine months ended September 30, 2025 of $ 1.0 million due to favorable return-to-provision adjustments attributable to certain foreign tax returns filed during July 2025 that was recorded as a discrete income tax benefit in the second quarter of 2025. The Company did no t have any unrecognized tax benefits as of September 30, 2025 related to uncertain tax positions that would impact the effective income tax rate if recognized .
The Company is currently under examination by the IRS for the Company’s 2021 U.S. income tax return. The Company is not currently under examination at the state level. The Company’s U.S. federal and state net operating losses have occurred since its inception in 2012 and as such, tax years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The Company does not expect material tax impacts from the legislation on its consolidated financial statements.

Note 17. Related Party Transactions
From the Company’s inception, Herriot Tabuteau, M.D. has been the Company’s founder, Chief Executive Officer, Chairman of the Company’s Board, and the beneficial owner of more than 5 % of the outstanding shares of the Company’s common stock. In connection with the formation of the Company, in January 2012, the Company issued to Antecip Bioventures II LLC, an entity controlled by Dr. Tabuteau, an aggregate of 7,344,500 shares of the Company’s common stock for nominal consideration. The Company recorded royalty expense of $ 10.6 million and $ 6.0 million for the nine months ended September 30, 2025 and 2024 , respectively, which equal 3.0 % of net sales for those respective periods.
The Company is a party to three exclusive license agreements with Antecip Bioventures II LLC, an entity owned by Dr. Tabuteau. See Note 14. License Agreements for further information regarding the license agreements.

33

Table of Contents

 

Note 18. Segment Information
The Company views its operations and manages its business as one operating and reportable segment, which is the business of developing and delivering novel therapies for the management of CNS disorders. The Company’s focus centers around the CNS disorders market as its primary operating environment. Consistent with the operational structure, the Chief Executive Officer , as the chief operating decision maker (“CODM”), manages and allocates resources on a consolidated basis. This decision making process reflects the way in which the financial information is regularly reviewed and used by the CODM to evaluate performance, set operational targets, forecast future financial results, and allocate resources.
The Company’s CODM assesses financial performance and allocates resources based on consolidated net loss that also is reported on the consolidated statements of operations. The measure of segment assets is reported on the balance sheet as total consolidated assets. The CODM utilizes consolidated net loss by comparing actual results against budgeted amounts on a quarterly basis. As part of this process, consolidated net loss is a critical performance measure used to evaluate the Company’s operating performance and guide strategic decisions and resource allocations, including additional investments in research and development and commercialization activities.
The following table provides information about the Company’s one reportable segment and includes the reconciliation to consolidated net loss.
 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Total revenues

 

$

170,992

 

 

$

104,762

 

 

$

442,497

 

 

$

266,927

 

Less:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue (excluding amortization and depreciation)

 

 

11,912

 

 

 

8,437

 

 

 

35,149

 

 

 

22,789

 

Research and development expense (excluding share-based compensation expense):

 

 

 

 

 

 

 

 

 

 

 

 

Solriamfetol

 

 

9,518

 

 

 

13,711

 

 

 

32,094

 

 

 

37,908

 

AXS-05

 

 

13,855

 

 

 

14,802

 

 

 

42,896

 

 

 

44,090

 

AXS-07

 

 

4,825

 

 

 

2,512

 

 

 

15,379

 

 

 

9,457

 

AXS-12

 

 

1,873

 

 

 

1,911

 

 

 

6,019

 

 

 

7,035

 

AXS-14

 

 

( 1,460

)

 

 

3,516

 

 

 

5,951

 

 

 

9,886

 

Other research and development (a)

 

 

4,744

 

 

 

3,067

 

 

 

11,942

 

 

 

8,186

 

General and administrative expense (excluding share-based compensation expense)

 

 

19,739

 

 

 

11,587

 

 

 

44,623

 

 

 

36,427

 

Selling and marketing expense (excluding share-based compensation expense)

 

 

114,200

 

 

 

68,186

 

 

 

305,864

 

 

 

213,938

 

Share based compensation expense

 

 

23,103

 

 

 

21,660

 

 

 

71,022

 

 

 

63,232

 

Loss in fair value of contingent consideration

 

 

13,185

 

 

 

16,391

 

 

 

6,595

 

 

 

17,139

 

Interest expense, net (b)

 

 

1,120

 

 

 

1,978

 

 

 

5,385

 

 

 

4,359

 

Other segment items (c)

 

 

1,607

 

 

 

1,606

 

 

 

14,193

 

 

 

4,785

 

Segment net loss

 

 

( 47,229

)

 

 

( 64,602

)

 

 

( 154,615

)

 

 

( 212,304

)

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of net loss

 

 

 

 

 

 

 

 

 

 

 

 

Adjustments and reconciling items

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Consolidated net loss

 

 

( 47,229

)

 

 

( 64,602

)

 

 

( 154,615

)

 

 

( 212,304

)

(a) Other research and development expenses primarily consist of facilities charges, third party consultant costs, costs related to other product candidates, and other unallocated costs.

(b) Interest expense, net of $ 1,120 for the three months ended September 30, 2025 comprises (i) consolidated interest expense of $ 3,375 and (ii) consolidated interest income of $ 2,255 . Interest expense, net of $ 5,385 for the nine months ended September 30, 2025 comprises (i) consolidated interest expense of $ 12,719 and (ii) consolidated interest income of $ 7,334 . Interest expense, net of $ 1,978 for the three months ended September 30, 2024 comprises (i) consolidated interest expense of $ 5,666 and (ii) consolidated interest income of $ 3,688 . Interest expense, net of $ 4,359 for the nine months ended September 30, 2024 comprises (i) consolidated interest expense of $ 16,151 and (ii) consolidated interest income of $ 11,792 .

(c) Other segment items included in Segment net loss include intangible asset amortization, loss on debt extinguishment, and other miscellaneous items.

34

Table of Contents

 

See Note 2. Summary of Significant Accounting Policies for further details on the products from which the Company derives its revenues.
See Note 13. Revenues for details of revenue from external customers by geography.

35

Table of Contents

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS O F FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future. Forward-looking statements are based on a number of assumptions and estimates that are inherently subject to significant risks and uncertainties, and our results could differ materially from the results anticipated by our forward-looking statements as a result of many known or unknown factors, including, but not limited to, those factors discussed in “Risk Factors.” See also the “Cautionary Note Regarding Forward-Looking Statements” set forth at the beginning of this report.
You should read the following discussion and analysis in conjunction with the unaudited interim consolidated financial statements, and the related footnotes thereto, appearing elsewhere in this report, and in conjunction with management’s discussion and analysis and the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024 which was filed with the U.S. Securities and Exchange Commission, or SEC, on February 18, 2025 .
Overview
We are a biopharmaceutical company dedicated to the development and commercialization of innovative medicines for people living central nervous system (“CNS”) conditions.
Commercial Products
1. Auvelity ® . Auvelity (dextromethorphan-bupropion) is a novel, oral, N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 receptor agonist, aminoketone, and CYP2D6 inhibitor. Auvelity was developed by the Company and approved by the FDA for the treatment of major depressive disorder (MDD) in adults in August 2022. We initiated the commercial launch of Auvelity in the United States in October 2022. We refer to the proprietary dextromethorphan-bupropion formulation contained in Auvelity as AXS-05. As used in this report, “Auvelity” refers to AXS-05 approved by the FDA for the treatment of MDD in adults, and “AXS-05” refers to, where applicable, Auvelity as well as AXS-05 for the treatment of indications beyond MDD in adults.

2. Sunosi ® . Sunosi (solriamfetol) is a novel, oral, dopamine and norepinephrine reuptake inhibitor (DNRI), trace amine-associated receptor 1 (TAAR1) agonist, and 5-HT 1A agonist. Sunosi was approved for the treatment of EDS in adult patients with narcolepsy or obstructive sleep apnea (OSA) by the FDA in 2019 and by the European Commission in 2020. We acquired the U.S. rights to Sunosi from Jazz Pharmaceuticals plc, or Jazz, in May 2022 and the ex-U.S. rights (excluding certain Asian markets) from Jazz in November 2022. We have been commercializing Sunosi since we completed these acquisitions. SK Biopharmaceuticals Co. Ltd., or SK, is the originator of Sunosi and retains rights in 12 Asian markets, including China, Korea, and Japan. We refer to the acquisition of Sunosi herein as the Acquisition. In February 2023, we entered into a licensing agreement, or the Pharmanovia License Agreement, with Atnahs Pharma UK Limited, or Pharmanovia, that granted to Pharmanovia the exclusive right to market Sunosi in Europe and certain countries in the Middle East and North Africa, referred to as the Licensed Territory. As used in this report, “Sunosi” refers to solriamfetol approved for the treatment of EDS in patients with narcolepsy or OSA, and “solriamfetol” refers to, where applicable, Sunosi as well as solriamfetol for the treatment of indications beyond EDS in patients with narcolepsy or OSA.

3. Symbravo ® . Symbravo (MoSEIC TM meloxicam-rizatriptan) is a novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT 1B/1D agonist. Symbravo was developed by the Company and approved by the FDA for the acute treatment of migraine with or without aura in adults in January 2025. We initiated the commercial launch of Symbravo in the United States in June 2025.

36

Table of Contents

 

Pipeline
We are advancing a diversified, late-stage pipeline of novel product candidates for serious neurological and psychiatric conditions.
AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist, sigma-1 receptor agonist, aminoketone, and CYP2D6 inhibitor being developed for the treatment of Alzheimer’s disease agitation, or AD agitation, and smoking cessation. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components. We have submitted a supplemental NDA (sNDA) to the FDA for AXS-05 in AD agitation supported by four completed Phase 3, placebo-controlled efficacy trials and a long-term safety trial. AXS-05 has been granted FDA Breakthrough Therapy designation for AD agitation.
Solriamfetol is a novel, oral, investigational DNRI, TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (“ADHD”), major depressive disorder (MDD) with EDS, binge eating disorder (“BED”) and excessive sleepiness associated with shift work disorder (“SWD”). In March 2025, we announced topline results from the FOCUS Phase 3 trial of solriamfetol in ADHD in adults, and in April 2025, we announced topline results from the PARADIGM Phase 3 trial of solriamfetol in MDD. Enrollment for the ENGAGE and SUSTAIN Phase 3 trials of solriamfetol in BED and SWD, respectively, are ongoing.
AXS-12 (reboxetine) is a novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. We have successfully completed three Phase 2 and Phase 3, placebo-controlled efficacy trials and a long-term safety trial. AXS-12 has been granted FDA Orphan Drug Designation for narcolepsy.
AXS-14 (esreboxetine) is a novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. In May 2025, we announced that we submitted an NDA to the FDA for AXS-14 for the management of fibromyalgia. In June 2025, we received a Refusal to File letter from the FDA for the NDA. To address the FDA’s feedback, Axsome will conduct an additional controlled trial, which will use a fixed-dose paradigm and a 12-week primary endpoint as requested by the FDA.
Since our incorporation in January 2012, our operations to date have included organizing and staffing our company, business planning, raising capital, developing our compounds, engaging in other discovery and preclinical activities, and the commercial launches of Auvelity, Sunosi, and Symbravo. Subsequent to our IPO, we financed our operations primarily through proceeds from sales of our common stock to equity investors and debt borrowings. For a further discussion, see the section entitled “Liquidity and Capital Resources” below.
Our ability to become profitable depends on our ability to generate revenue. We have begun commercial sales of Auvelity, Sunosi, and Symbravo, but we have limited experience with commercializing these, or any, products.
We have incurred significant operating and net losses since inception. We incurred net losses of $154.6 million and $212.3 million for the nine months ended September 30, 2025 and 2024, respectively. Our accumulated deficit as of September 30, 2025 was $1,277.4 million, and we expect to incur significant expenses and continuing operating losses. We expect our expenses to increase in connection with our ongoing activities, as we continue the commercialization of our on-market products and the development and clinical trials of, and seek regulatory approval for, our current product candidates and any other product candidates that we develop or in-license and advance to clinical development. Further, we have incurred and will continue to incur additional costs associated with operating as a public company. Accordingly, we may need additional financing to support our continuing operations. We may seek to fund our operations through public or private equity, debt financings, or other sources. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.

37

Table of Contents

 

Financial Overview
Revenue
We generated total revenues of $171.0 million and $104.8 million in the three months ended September 30, 2025 and 2024, respectively, and $442.5 million and $266.9 million in the nine months ended September 30, 2025 and 2024, respectively.
We expect that Auvelity, Sunosi, and Symbravo revenues are likely to fluctuate based on demand quarter to quarter. We will not generate revenue from other products unless and until we successfully develop, obtain regulatory approval of, and commercialize one of our current or future product candidates. We have incurred significant operating losses since inception. If we fail to complete the development of our product candidates in a timely manner or obtain regulatory approval for them, our ability to generate future revenue from such product candidates, and our results of operations and financial position, would be materially and adversely affected. If we enter into licensing or collaboration arrangements, such agreements may or may not generate revenue in the future.
License Agreement with Pharmanovia
In February 2023, we entered into the Pharmanovia License Agreement with Pharmanovia to commercialize and further develop Sunosi in the Territory. Pharmanovia is a UK-based global life cycle management healthcare company that focuses on four core therapeutic areas – Oncology, Endocrinology, Neurology and Cardiovascular.
We are eligible to receive sales-based and other milestone payments totaling up to €94.5 million. We will receive a royalty percentage in the mid-twenties on net sales of the Licensed Products (as defined in the Pharmanovia License Agreement) in the Territory. We recognized royalty revenue of $1.2 million and $1.0 million for the three months ended September 30, 2025 and 2024, respectively, and $3.4 million and $2.6 million for the nine months ended September 30, 2025 and 2024, respectively, related to Pharmanovia’s sales of Sunosi.
Cost of revenue
Cost of revenue includes direct costs of formulating, manufacturing and packaging drug product, overhead costs consisting of labor, customs, stock-based compensation, shipping, outside inventory management, royalty expense, and other miscellaneous operating costs.
Research and development expenses
Research and development expenses primarily include preclinical studies, clinical trials, manufacturing costs, employee-related expenses including salaries, benefits, travel, and stock‑based compensation expense, contract services, including external research and development expenses incurred under arrangements with third parties, such as contract research organizations, or CROs, facilities costs, overhead costs, depreciation, and other related costs.
Research and development activities are central to our business model. We have and will incur substantial costs beyond our present and planned clinical trials in order to file an NDA for any of our product candidates. It is difficult to determine with certainty the costs and duration of our current or future clinical trials and preclinical studies, or to what extent we will generate revenue from the commercialization and sale of Auvelity, Sunosi, Symbravo or our product candidates if we obtain regulatory approval. The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including the uncertainties of future clinical trials and preclinical studies, uncertainties in clinical trial enrollment rate, and significant and changing government regulation. In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability, and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

38

Table of Contents

 

Management considers many factors in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements if these results differ from historical experience, or other assumptions do not turn out to be substantially accurate, even if such assumptions are reasonable when made.
Selling, general and administrative expenses
Selling, general and administrative expenses consist of salaries and related costs for personnel in executive, commercial, finance, and operational functions, including stock-based compensation and travel expenses. Also included in selling, general and administrative expenses are marketing costs, other commercial costs, pre-commercialization costs, facility-related costs, insurance expense, professional fees for legal and accounting services, and patent filing and prosecution costs. Selling, general and administrative expenses are expensed when incurred.
Interest expense, net
Interest expense, net primarily consists of cash interest and non-cash costs related to our term loans (see “Liquidity and Capital Resources” below for a further discussion). We amortize these costs over the term of our debt agreements as interest expense in our consolidated statement of operations. Interest expense, net also includes interest income earned on cash and cash equivalents.
Critical Accounting Policies and Significant Judgments and Estimates
This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America, or GAAP. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reported period. In accordance with GAAP, we base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.
Reserves for Variable Consideration
Medicare Part D Program Redesign - Effective January 1, 2025, the Medicare Part D coverage gap program was replaced with a redesigned program under the Inflation Reduction Act of 2022. The standard Part D benefit now comprises three phases: the deductible phase, the initial coverage phase and the catastrophic coverage phase. Applicable dispensed drugs will be subject to manufacturer discounts of 10% during the initial coverage phase and 20% during the catastrophic coverage phase. We estimate the percentage of goods sold to patients in the initial coverage and catastrophic coverage phases and adjusts the transaction price for such discount at the time of sale resulting in a reduction to product sales as well as a component of accrued expenses and other current liabilities.
Except for the Medicare Part D Program Redesign, as discussed above, there have been no material changes to the critical accounting policies disclosed in our 2024 Annual Report on Form 10-K. Our critical accounting policies are described in the notes to the consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

39

Table of Contents

 

Results of Operations
The following table summarizes our results of operations for the periods indicated (in thousands, except share and per share amounts):

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

169,784

 

 

$

103,736

 

 

$

439,101

 

 

$

264,352

 

Royalty revenue

 

 

1,208

 

 

 

1,026

 

 

 

3,396

 

 

 

2,575

 

Total revenues

 

 

170,992

 

 

 

104,762

 

 

 

442,497

 

 

 

266,927

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue (excluding amortization and depreciation)

 

 

11,912

 

 

 

8,437

 

 

 

35,149

 

 

 

22,789

 

Research and development

 

 

40,162

 

 

 

45,388

 

 

 

134,488

 

 

 

132,071

 

Selling, general and administrative

 

 

150,235

 

 

 

95,564

 

 

 

401,302

 

 

 

298,088

 

Loss in fair value of contingent consideration

 

 

13,185

 

 

 

16,391

 

 

 

6,595

 

 

 

17,139

 

Intangible asset amortization

 

 

1,607

 

 

 

1,606

 

 

 

4,768

 

 

 

4,785

 

Total operating expenses

 

 

217,101

 

 

 

167,386

 

 

 

582,302

 

 

 

474,872

 

Loss from operations

 

 

(46,109

)

 

 

(62,624

)

 

 

(139,805

)

 

 

(207,945

)

Interest expense, net

 

 

(1,120

)

 

 

(1,978

)

 

 

(5,385

)

 

 

(4,359

)

Loss on debt extinguishment

 

 

—

 

 

 

—

 

 

 

(10,385

)

 

 

—

 

Loss before income taxes

 

 

(47,229

)

 

 

(64,602

)

 

 

(155,575

)

 

 

(212,304

)

Income tax benefit

 

 

—

 

 

 

—

 

 

 

960

 

 

 

—

 

Net loss

 

$

(47,229

)

 

$

(64,602

)

 

$

(154,615

)

 

$

(212,304

)

Net loss per common share, basic and diluted

 

$

(0.94

)

 

$

(1.34

)

 

$

(3.13

)

 

$

(4.45

)

Weighted average common shares outstanding, basic and diluted

 

 

50,021,851

 

 

 

48,140,519

 

 

 

49,449,220

 

 

 

47,703,508

 

Product sales, net. Auvelity U.S. net sales were $136.1 million and $352.0 million for the three and nine months ended September 30, 2025, respectively, as compared to $80.4 million and $198.8 million for the same periods in 2024. Sunosi net sales were $31.6 million and $84.6 million for the three and nine months ended September 30, 2025, respectively, as compared to $23.4 million and $65.6 million for the same periods in 2024. We began commercial sales of Symbravo in June 2025 and had U.S. net sales of $2.1 million and $2.5 million for the three and nine months ended September 30, 2025. There were no Symbravo sales recorded in 2024, which reflects the timing of the Symbravo approval and launch. The increases in both comparable periods were primarily due to the increase in unit sales volume for both Auvelity and Sunosi, and commercial launch of Symbravo in June 2025.
The following table summarizes the activity of our sales allowance and reserves as of and for the nine months ended September 30, 2025 (in thousands):

 

 

Commercial discounts and rebates, returns and other

 

 

Cash discounts and chargebacks

 

 

Medicaid and Medicare rebates

 

 

Total

 

Balance at December 31, 2024

 

$

55,412

 

 

$

13,504

 

 

$

18,538

 

 

$

87,454

 

Provisions

 

 

268,243

 

 

 

104,756

 

 

 

68,512

 

 

 

441,511

 

Payments/credits

 

 

(238,407

)

 

 

(98,919

)

 

 

(32,830

)

 

 

(370,156

)

Balance at September 30, 2025

 

$

85,248

 

 

$

19,341

 

 

$

54,220

 

 

$

158,809

 

 

40

Table of Contents

 

Royalty revenue. In connection with the February 2023 Pharmanovia License Agreement to commercialize Sunosi in certain ex-U.S. markets, we recognized royalty revenue of $1.2 million and $3.4 million for the three and nine months ended September 30, 2025, respectively, as compared to $1.0 million and $2.6 million for the same periods in 2024 attributable to Pharmanovia sales of Sunosi in the out-licensed markets. The increases in both comparable periods were in line with the increase in unit sales volume of Sunosi in certain ex-U.S. markets.
Cost of revenue. Cost of revenue was $11.9 million and $35.1 million for the three and nine months ended September 30, 2025, respectively, as compared to $8.4 million and $22.8 million for the same periods in 2024. The increase was in line with the increase in sales of Auvelity and Sunosi, and commercial launch of Symbravo in June 2025.
Research and development. The following table summarizes our research and development expenses for our primary products for the three and nine months ended September 30, 2025 and 2024 (in thousands):

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Solriamfetol

 

$

9,518

 

 

$

13,711

 

 

$

32,094

 

 

$

37,908

 

AXS-05

 

 

13,855

 

 

 

14,802

 

 

 

42,896

 

 

 

44,090

 

AXS-07

 

 

4,825

 

 

 

2,512

 

 

 

15,379

 

 

 

9,457

 

AXS-12

 

 

1,873

 

 

 

1,911

 

 

 

6,019

 

 

 

7,035

 

AXS-14

 

 

(1,460

)

 

 

3,516

 

 

 

5,951

 

 

 

9,886

 

Other research and development (*)

 

 

4,744

 

 

 

3,067

 

 

 

11,942

 

 

 

8,186

 

Stock-based compensation

 

 

6,807

 

 

 

5,869

 

 

 

20,207

 

 

 

15,509

 

Total research and development expenses

 

$

40,162

 

 

$

45,388

 

 

$

134,488

 

 

$

132,071

 

(*) Other research and development expenses primarily consist of facilities charges, third party consultant costs, costs related to other product candidates, and other unallocated costs.
Research and development expenses decreased by $5.2 million and increased by $2.4 million for the three and nine months ended September 30, 2025, respectively, as compared to the same periods in 2024. The decrease in the three months ended comparable period was due to the completion of trials for solriamfetol in ADHD and MDD and a refund of a regulatory filing fee related to AXS-14, partially offset by ongoing supplier validation costs for AXS-07. The increase in the nine months ended comparable period was due to the ongoing supplier validation costs for AXS-07, partially offset by lower spending due to completion of trials for MDD and ADHD for solriamfetol. We expect research and development costs to moderately increase through the end of 2025 and into 2026 as new development programs commence while certain development programs near completion.
Selling, general and administrative. Selling, general and administrative expenses were $150.2 million and $401.3 million for the three and nine months ended September 30, 2025, respectively, as compared to $95.6 million and $298.1 million for the same periods in 2024. The increases in both comparable periods were related to higher commercial activities for Auvelity, including a sales force expansion and a national direct-to-consumer advertising campaign, commercial launch of Symbravo, and higher personnel costs related to organizational growth, including non-cash stock-based compensation. We anticipate modest growth in SG&A expenses through 2025 and into 2026 as we increase marketing and promotional spending for Auvelity.
Loss in Fair Value of Contingent Consideration. The $13.2 million and $6.6 million changes for the three and nine months ended September 30, 2025, respectively, as compared to $16.4 million and $17.1 million changes for the same periods in 2024, were primarily related to changes in significant unobservable inputs, including discount rates.
Intangible asset amortization . We amortize the intangible asset, which we recognized as part of the Acquisition, over its useful life of 10 years. Intangible asset amortization was $1.6 million for both the three months ended September 30, 2025 and 2024 and $4.8 million for both the nine months ended September 30, 2025 and 2024.
Interest expense, net. Interest expense, net was $1.1 million and $5.4 million for the three and nine months ended September 30, 2025, respectively, as compared to $2.0 million and $4.4 million for the same periods in 2024. The decrease in the three months ended comparable period was due to the lower interest expense from the Blackstone Loan Agreement, which was partially offset by less interest income on lower cash balances. The increase in the nine months ended comparable period was mainly due to less interest income on lower cash balances.

41

Table of Contents

 

Income tax expense. We did not record an income tax expense or benefit for the three months ended September 30, 2025. We recorded a tax benefit of $1.0 million for the nine months ended September 30, 2025 due to favorable return-to-provision adjustments attributable to certain foreign tax returns filed during July 2025 that were recorded as a discrete tax benefit in the second quarter of 2025. We did not record an income tax benefit or expense for the same periods in 2024.
Net loss. Net loss was $47.2 million and $154.6 million for the three and nine months ended September 30, 2025, respectively, as compared to $64.6 million and $212.3 million for the same periods in 2024. The decreases in both comparable periods were primarily due to higher sales which was partially offset by higher research and development spend from ongoing clinical trial expenses, higher selling, general and administrative expenses from commercial activities related to Auvelity and Symbravo, including sales force and marketing spend, and higher personnel costs due to organizational growth, including non-cash stock compensation expense.
Liquidity and Capital Resources
Since our inception through September 30, 2025, we have financed our operations primarily through proceeds from equity offerings, debt borrowings, and proceeds from product sales. See discussion below.
Contemporaneously herewith, we filed an automatic shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities, and units up to an unlimited amount, which we refer to as the 2025 Shelf Registration Statement. In the future, we may conduct additional offerings of one or more of these securities utilizing the 2025 Shelf Registration Statement in such amounts, prices and terms to be announced when and if the securities are offered. At the time any of our securities covered by the 2025 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.
Also contemporaneously herewith, in connection with the 2025 Shelf Registration Statement, we filed a new sales agreement prospectus to replace the prior prospectus supplement filed in December 2022 associated with the 2022 Shelf Registration Statement, which would have expired in December 2025. The new sales agreement prospectus covered the issuance and sale by us of up to the same $250 million of our common stock that may be issued and sold from time to time through Leerink, as the sales agent, under the March 2022 Sales Agreement.
In March 2022, we entered into a sales agreement, or the March 2022 Sales Agreement with Leerink, and filed a prospectus supplement. The March 2022 Sales Agreement supersedes the sales agreement, dated December 5, 2019, by and between us and Leerink. We exhausted sales of shares of our common stock under our prior at-the-market offering program.
Under the March 2022 Sales Agreement, for the nine months ended September 30, 2025, we received approximately $47.2 million in gross proceeds through the sale of 411,482 shares, of which net proceeds were approximately $46.3 million.
In June 2023, we completed an underwritten public offering of our common stock and sold 3.0 million shares of our common stock at a public offering price of $75.00 per share. Net proceeds were $211.3 million, net of underwriting discounts and commissions of $13.5 million and other offering costs of $0.2 million. Additionally, in connection with this public offering, in July 2023, the underwriters fully exercised their option to purchase 450,000 additional shares of our common stock, at a public offering price of $75.00 per share. The net proceeds were $31.7 million, net of underwriting discounts and commissions of $2.0 million and other minimal offering costs.
In the future, we may conduct additional offerings of one or more of the securities covered by the 2025 Shelf Registration Statement in such amounts, prices and terms to be announced when and if the securities are offered. At the time any of our securities covered by the 2025 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.
On February 21, 2023, we entered into a Sublease with Advance Magazine Publishers d/b/a Conde Nast for the entirety of the twenty-second floor of One Word Trade Center in New York, NY, or the Initial Sublease.

42

Table of Contents

 

On January 17, 2025, we entered into an Amendment to our Sublease, or First Amendment, pursuant to which we relinquished our then existing space in One World Trade Center and commenced occupancy of different space within the building. This space is utilized as our corporate and executive offices. The First Amendment extends the Initial Sublease expiration date to January 31, 2036. We now have a one-time option to terminate the Sublease effective March 30, 2031 upon the payment of a fee to the sublandlord. The Company is responsible for base rent under the Sublease and certain additional customary variable costs, such as an allocable portion of building taxes and operating expenses. In connection with the Initial Sublease and First Amendment, we received certain rent and work concessions from the sublandlord.
The Company entered into a fleet lease program beginning the first quarter of 2024. The lease agreement includes an initial 12-month noncancelable period with monthly renewal options thereafter. Lease terms range from approximately 40 to 50 months and are classified as finance leases. See Note 9. Commitments and Contingencies for further information on future contractual obligations.
As described below in the “Loan Agreement with Blackstone” section, on May 8, 2025, we entered into a loan agreement (the “Blackstone Loan Agreement”) with Blackstone Alternative Credit Advisors LP and Blackstone Life Sciences Advisors L.L.C. (collectively, the “Blackstone Representative” and referred to herein as “Blackstone”), certain subsidiaries of our party thereto as guarantors, Wilmington Trust, National Association, as agent, and the lenders from time to time party thereto (collectively, the “Lenders”). The Blackstone Loan Agreement provides for Loans in an aggregate principal amount of up to $570.0 million.
On May 8, 2025, we repaid in full our obligations under the Hercules Loan Agreement using proceeds from the Blackstone Loan Agreement. As of September 30, 2025, there are no outstanding obligations under the Hercules Loan Agreement.
We believe that our current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan. Because the process of commercializing products and evaluating product candidates in clinical trials is costly and the timing of progress in these trials is uncertain, it is possible that the assumptions upon which we have based this estimate may prove to be wrong, and we could use our capital resources sooner than we currently expect.
Cash Flows
The following table summarizes our primary sources and uses of cash for the periods indicated (in thousands):

 

 

Nine months ended September 30,

 

 

 

2025

 

 

2024

 

Net cash (used in) provided by:

 

 

 

 

 

 

Operating activities

 

$

(74,752

)

 

$

(102,208

)

Investing activities

 

 

(409

)

 

 

(240

)

Financing activities

 

 

85,080

 

 

 

43,596

 

Net increase (decrease) in cash

 

$

9,919

 

 

$

(58,852

)

Operating Activities. Cash used in operating activities for the nine months ended September 30, 2025 was $74.8 million, as compared to $102.2 million for the same period in 2024. The decrease of $27.4 million was primarily due to higher net product revenues from Auvelity and Sunosi in 2025, which was partially offset by an increase in cash used in commercial and clinical related activities.
Investing Activities. Cash used in investing activities for the nine months ended September 30, 2025 was $409 thousand, as compared to $240 thousand for the same period in 2024. The increase was attributable to additional equipment purchases in 2025 to support our expanded office space and workforce.

43

Table of Contents

 

Financing Activities. Cash provided by financing activities was $85.1 million for the nine months ended September 30, 2025, which included net proceeds of $256.4 million from draw-downs related to the Blackstone Loans and net proceeds of $61.1 million from issuance of common stock for financing purposes as well as proceeds of $44.2 million from the issuance of common stock upon the exercise of employee stock options and under the ESPP, which was partially offset by the repayment of the Hercules Loan and revolving loan commitments under the Blackstone Loan Agreement, for a total of $262.0 million, and payments of contingent consideration and tax withholdings on stock awards, for a total of $13.1 million. Cash provided by financing activities was $43.6 million for the nine months ended September 30, 2024, which included net proceeds of $23.9 million from issuance of common stock for financing purposes as well as proceeds of $29.5 million from the issuance of common stock upon the exercise of employee stock options and under the ESPP, which was partially offset by payments of contingent consideration and tax withholdings on stock awards, for a total of $9.2 million.
Funding Requirements
We have not achieved profitability since our inception, and we expect to continue to have losses as we continue the development of, and seek regulatory approvals for, our product candidates, while further investing in Auvelity, Sunosi, and Symbravo. We are subject to all of the risks pertinent to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may harm our business.
We may need to raise additional financing in the future to fund our operations. In the event that we need additional financing, we may incur additional debt, license certain intellectual property, and seek to sell additional equity or convertible securities that may result in dilution to our stockholders. If we raise additional funds through the issuance of equity or convertible securities, these securities could have rights or preferences senior to those of our common stock and could contain covenants that restrict our operations. There can be no assurance that we will be able to obtain additional equity or debt financing on terms acceptable to us, if at all. Our future capital requirements will depend on many factors, including:
• the scope, rate of progress, results, and cost of our clinical studies and other related activities;

• our ability to enter into collaborative agreements for the development and commercialization of our product candidates;

• the number and development requirements of any other product candidates that we pursue;

• the costs, timing, and outcome of regulatory reviews of our product candidates;

• the costs and timing of our commercialization activities, including product manufacturing, marketing, sales, and distribution, for any of our products and product candidates for which we receive marketing approval;

• any product liability or other lawsuits related to our product candidates;

• the expenses needed to attract and retain skilled personnel;

• the general and administrative expenses related to being a public company;