10-Q
falsefalseP3YP7YQ30001029142false--12-310001029142us-gaap:ConvertibleNotesPayableMember2021-07-012021-09-300001029142srt:MaximumMemberdvax:MarketBasedPerformanceStockUnitMember2021-01-012021-09-300001029142us-gaap:InventoriesMember2021-07-012021-09-300001029142us-gaap:CorporateDebtSecuritiesMemberus-gaap:AvailableforsaleSecuritiesMember2020-12-310001029142srt:MaximumMemberus-gaap:EmployeeStockOptionMember2021-01-012021-09-300001029142stpr:CAdvax:HortonStreetMasterLeaseMember2018-09-170001029142us-gaap:NonUsMemberus-gaap:ProductMember2021-01-012021-09-300001029142us-gaap:CommonStockMember2020-09-300001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-07-012020-09-300001029142us-gaap:FairValueInputsLevel2Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142stpr:CAus-gaap:OtherNonoperatingIncomeExpenseMemberdvax:HortonStreetSubleaseMember2021-01-012021-09-3000010291422020-01-012020-09-3000010291422021-01-012021-09-300001029142dvax:DebtInstrumentConversionPeriodOneMembersrt:MaximumMemberdvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember2021-01-012021-09-300001029142us-gaap:RestrictedStockUnitsRSUMember2021-09-300001029142us-gaap:WarrantMember2021-01-012021-09-300001029142us-gaap:AdditionalPaidInCapitalMember2020-07-012020-09-300001029142us-gaap:SalesRevenueNetMemberdvax:CpG1018Memberdvax:SecondLargestCollaborationPartnerMemberus-gaap:ProductConcentrationRiskMember2020-07-012020-09-300001029142srt:MaximumMemberdvax:TwentySeventeenAtTheMarketAgreementMember2017-11-032017-11-030001029142us-gaap:WarrantMembersrt:MaximumMember2021-01-012021-09-300001029142us-gaap:SellingGeneralAndAdministrativeExpensesMember2020-07-012020-09-3000010291422020-07-012020-09-300001029142us-gaap:RetainedEarningsMember2021-01-012021-09-300001029142dvax:CappedCallsMember2021-01-012021-09-300001029142dvax:SupplyAgreementMemberdvax:MedigenVaccineBiologicsMember2021-07-012021-09-300001029142dvax:SupplyAgreementMemberdvax:ValnevaSEMember2021-09-300001029142us-gaap:SalesRevenueNetMemberdvax:CpG1018Memberdvax:SecondLargestCollaborationPartnerMemberus-gaap:ProductConcentrationRiskMember2020-01-012020-09-3000010291422021-11-010001029142us-gaap:RetainedEarningsMember2019-12-310001029142stpr:CAdvax:PowellStreetSubleaseMember2019-07-012019-07-310001029142dvax:TwoThousandAndEighteenEquityIncentivePlanMember2021-01-310001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-01-012020-09-300001029142dvax:Cpg1018AdjuvantInventoryMember2021-09-300001029142us-gaap:CashMemberus-gaap:CashAndCashEquivalentsMember2021-09-300001029142us-gaap:SellingGeneralAndAdministrativeExpensesMember2021-07-012021-09-300001029142dvax:LoanAgreementMember2020-01-012020-09-300001029142us-gaap:CommonStockMember2021-01-012021-09-300001029142dvax:SupplyAgreementMemberdvax:ValnevaSEMember2021-01-012021-09-300001029142us-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142stpr:CAdvax:HortonStreetSubleaseMember2019-07-012019-07-310001029142dvax:GrantAgreementMemberdvax:BillAndMelindaGatesFoundationMember2021-01-012021-09-300001029142us-gaap:PreferredStockMember2021-01-012021-09-300001029142us-gaap:FairValueInputsLevel2Memberus-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-07-012021-09-300001029142dvax:CappedCallsMember2021-05-012021-05-310001029142us-gaap:IPOMember2020-05-012020-05-310001029142us-gaap:PreferredStockMember2020-09-300001029142us-gaap:NonUsMemberdvax:CpG1018Member2021-07-012021-09-300001029142us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142us-gaap:AdditionalPaidInCapitalMember2021-01-012021-09-3000010291422019-08-310001029142us-gaap:NonUsMember2021-07-012021-09-300001029142us-gaap:ResearchAndDevelopmentExpenseMember2021-07-012021-09-300001029142us-gaap:NonUsMemberdvax:CpG1018Member2020-01-012020-09-300001029142us-gaap:RetainedEarningsMember2020-12-310001029142us-gaap:NonUsMemberdvax:CpG1018Member2020-07-012020-09-300001029142us-gaap:SalesRevenueNetMemberdvax:CpG1018Memberdvax:LargestCollaborationPartnerMemberus-gaap:ProductConcentrationRiskMember2020-01-012020-09-300001029142us-gaap:NonUsMemberus-gaap:ProductMember2020-01-012020-09-300001029142us-gaap:WarrantMember2021-07-012021-09-300001029142dvax:TwoThousandAndEighteenEquityIncentivePlanMember2021-09-300001029142us-gaap:USTreasurySecuritiesMemberus-gaap:AvailableforsaleSecuritiesMember2021-09-300001029142dvax:DusseldorfLeaseMembercountry:DE2021-09-300001029142us-gaap:IPOMember2019-08-012019-08-310001029142dvax:BainLifeSciencesMember2019-08-012019-08-310001029142us-gaap:FairValueInputsLevel3Memberus-gaap:WarrantMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142us-gaap:SalesRevenueNetMemberdvax:LargestCustomerMemberus-gaap:ProductConcentrationRiskMemberdvax:HEPLISAVBMember2021-07-012021-09-300001029142us-gaap:ResearchAndDevelopmentExpenseMember2020-07-012020-09-300001029142us-gaap:AdditionalPaidInCapitalMember2020-09-300001029142dvax:CRGServicingLLCMember2019-03-290001029142srt:MaximumMemberdvax:TwoThousandAndFourteenEmployeeStockPurchasePlanMember2021-05-310001029142us-gaap:CostOfSalesMember2020-07-012020-09-300001029142us-gaap:AvailableforsaleSecuritiesMember2021-09-300001029142us-gaap:ConvertibleNotesPayableMember2020-07-012020-09-300001029142us-gaap:NonUsMemberdvax:CpG1018Member2021-01-012021-09-300001029142us-gaap:RetainedEarningsMember2020-09-300001029142us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142us-gaap:PreferredStockMember2020-06-300001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2019-12-310001029142dvax:DebtInstrumentConversionPeriodOneMemberdvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember2021-01-012021-09-300001029142us-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142us-gaap:ConvertibleNotesPayableMember2020-01-012020-09-300001029142us-gaap:CommonStockMember2020-01-012020-09-300001029142dvax:PerformanceBasedRestrictedStockUnitsMember2021-09-300001029142us-gaap:OtherNonoperatingIncomeExpenseMemberus-gaap:WarrantMember2020-07-012020-09-300001029142dvax:SymphonyDynamoHoldingsLlcMember2009-11-012009-11-300001029142dvax:CpG1018Memberdvax:LongTermDeferredRevenueMember2021-09-300001029142us-gaap:ProductMember2020-01-012020-09-300001029142dvax:CRGServicingLLCMember2018-02-192018-02-200001029142us-gaap:CashAndCashEquivalentsMemberus-gaap:MoneyMarketFundsMember2021-09-300001029142us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142dvax:StockOptionsAndShareAwardsMember2020-01-012020-09-300001029142us-gaap:AdditionalPaidInCapitalMember2020-06-3000010291422020-12-310001029142us-gaap:CashAndCashEquivalentsMemberus-gaap:MoneyMarketFundsMember2020-12-310001029142us-gaap:SalesRevenueNetMemberdvax:CpG1018Memberdvax:LargestCollaborationPartnerMemberus-gaap:ProductConcentrationRiskMember2021-01-012021-09-3000010291422021-09-012021-09-300001029142us-gaap:FairValueInputsLevel2Member2021-09-300001029142dvax:HEPLISAVBMember2021-01-012021-09-300001029142us-gaap:SellingGeneralAndAdministrativeExpensesMember2021-01-012021-09-300001029142us-gaap:WarrantMember2020-01-012020-09-300001029142us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142srt:MaximumMemberus-gaap:IPOMember2019-08-310001029142dvax:StockOptionsAndShareAwardsMember2021-01-012021-09-300001029142dvax:CpG1018Member2021-07-012021-09-300001029142us-gaap:ProductMember2020-07-012020-09-300001029142dvax:SeriesBConvertiblePreferredStockMember2021-09-300001029142dvax:CoalitionForEpidemicPreparednessInnovationsMember2021-01-310001029142us-gaap:RetainedEarningsMember2020-06-300001029142dvax:OtherRevenueMember2020-01-012020-09-300001029142dvax:HEPLISAVBMember2020-07-012020-09-300001029142us-gaap:AdditionalPaidInCapitalMember2020-01-012020-09-300001029142us-gaap:SalesRevenueNetMemberdvax:SecondLargestCustomerMemberdvax:HEPLISAVBMemberus-gaap:ProductConcentrationRiskMember2020-01-012020-09-300001029142dvax:SupplyAgreementMemberdvax:BiologicalELimitedMember2021-09-300001029142dvax:HortonStreetMasterLeaseMemberstpr:CA2018-09-162018-09-170001029142dvax:LoanAgreementMember2021-01-012021-09-300001029142srt:MinimumMemberus-gaap:EmployeeStockOptionMember2020-01-012020-09-300001029142dvax:LoanAgreementMember2021-07-012021-09-300001029142srt:MaximumMember2021-01-012021-09-300001029142us-gaap:IPOMemberdvax:BainCapitalLifeSciencesFundLimitedPartnerMember2020-05-012020-05-310001029142us-gaap:NonUsMemberdvax:OtherRevenueMember2020-07-012020-09-300001029142dvax:StockOptionsAndShareAwardsMember2021-07-012021-09-300001029142us-gaap:FairValueInputsLevel3Member2020-12-310001029142us-gaap:RestrictedStockUnitsRSUMember2021-01-012021-09-300001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-06-300001029142dvax:ReservationAgreementMemberdvax:CoalitionForEpidemicPreparednessInnovationsPartnersMember2021-05-030001029142us-gaap:FairValueInputsLevel2Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142us-gaap:AccountsReceivableMemberdvax:HEPLISAVBMember2021-01-012021-09-300001029142dvax:OtherRevenueMembercountry:US2021-07-012021-09-300001029142dvax:CpG1018Membercountry:US2021-01-012021-09-300001029142dvax:CRGServicingLLCMember2021-01-012021-06-300001029142us-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142country:US2020-01-012020-09-300001029142country:USdvax:HEPLISAVBMember2021-07-012021-09-300001029142us-gaap:WarrantMember2020-07-012020-09-300001029142dvax:BainLifeSciencesMemberus-gaap:CommonStockMember2021-06-300001029142us-gaap:PreferredStockMember2019-12-310001029142us-gaap:CommonStockMember2021-06-300001029142dvax:TwentySeventeenAtTheMarketAgreementMember2021-01-012021-09-300001029142us-gaap:CashMemberus-gaap:CashAndCashEquivalentsMember2020-12-310001029142us-gaap:CashAndCashEquivalentsMember2021-09-300001029142us-gaap:SalesRevenueNetMemberdvax:SecondLargestCustomerMemberus-gaap:ProductConcentrationRiskMemberdvax:HEPLISAVBMember2020-07-012020-09-300001029142us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142us-gaap:EmployeeStockOptionMember2020-01-012020-09-300001029142dvax:GrantAgreementMembersrt:MaximumMemberdvax:BillAndMelindaGatesFoundationMember2021-01-012021-09-300001029142us-gaap:ConvertiblePreferredStockMember2020-01-012020-09-300001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-06-300001029142us-gaap:RetainedEarningsMember2021-07-012021-09-300001029142dvax:CRGServicingLLCMember2018-02-200001029142country:USus-gaap:ProductMember2020-07-012020-09-300001029142us-gaap:NonUsMemberus-gaap:ProductMember2020-07-012020-09-300001029142us-gaap:PreferredStockMember2021-07-012021-09-300001029142dvax:CappedCallsMember2021-09-300001029142us-gaap:SalesRevenueNetMemberdvax:SecondLargestCustomerMemberdvax:HEPLISAVBMemberus-gaap:ProductConcentrationRiskMember2021-07-012021-09-300001029142us-gaap:PreferredStockMember2020-01-012020-09-300001029142dvax:DebtInstrumentConversionPeriodTwoMemberdvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember2021-01-012021-09-300001029142us-gaap:ConvertiblePreferredStockMember2020-07-012020-09-300001029142country:US2021-01-012021-09-300001029142dvax:CpG1018Member2021-09-300001029142dvax:HEPLISAVBMember2021-07-012021-09-300001029142dvax:SeriesBConvertiblePreferredStockMember2020-12-3100010291422020-09-300001029142dvax:MarketBasedPerformanceStockUnitMembersrt:MinimumMember2021-01-012021-09-300001029142us-gaap:RetainedEarningsMember2021-06-300001029142us-gaap:AccountsReceivableMemberdvax:HEPLISAVBMember2020-12-310001029142us-gaap:SalesRevenueNetMemberdvax:LargestCustomerMemberdvax:HEPLISAVBMemberus-gaap:ProductConcentrationRiskMember2020-07-012020-09-300001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-12-310001029142dvax:ZhejiangCloverBiopharmaceuticalsIncAndCloverHongKongIncMemberdvax:SupplyAgreementMember2021-01-012021-09-300001029142dvax:CpG1018Member2021-01-012021-09-300001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-01-012021-09-300001029142dvax:Cpg1018AdjuvantInventoryMember2020-12-310001029142us-gaap:ProductMember2021-07-012021-09-300001029142dvax:GrantAgreementMemberdvax:BillAndMelindaGatesFoundationMember2021-09-300001029142us-gaap:ConvertibleNotesPayableMember2021-01-012021-09-300001029142us-gaap:FairValueInputsLevel3Memberus-gaap:WarrantMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142dvax:CpG1018Member2021-01-012021-09-300001029142us-gaap:OtherNonoperatingIncomeExpenseMemberstpr:CAdvax:HortonStreetSubleaseMember2020-01-012020-09-300001029142us-gaap:SalesRevenueNetMemberdvax:ThirdLargestCustomerMemberus-gaap:ProductConcentrationRiskMemberdvax:HEPLISAVBMember2020-07-012020-09-300001029142us-gaap:ConvertiblePreferredStockMember2021-07-012021-09-300001029142dvax:HEPLISAVBMember2021-01-012021-09-300001029142us-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:AvailableforsaleSecuritiesMember2021-09-300001029142stpr:CAdvax:PowellStreetSubleaseMember2019-07-310001029142srt:MaximumMemberus-gaap:IPOMember2020-05-012020-05-310001029142us-gaap:IPOMember2020-05-310001029142us-gaap:RetainedEarningsMember2020-01-012020-09-300001029142dvax:ReservationAgreementMemberdvax:CoalitionForEpidemicPreparednessInnovationsPartnersMember2021-05-022021-05-030001029142srt:MinimumMemberus-gaap:EmployeeStockOptionMember2020-07-012020-09-300001029142dvax:HEPLISAVBMember2021-09-300001029142stpr:CAdvax:HortonStreetSubleaseMember2019-07-310001029142dvax:SeriesBConvertiblePreferredStockMember2021-08-012021-08-310001029142us-gaap:AvailableforsaleSecuritiesMember2020-12-310001029142us-gaap:SalesRevenueNetMemberdvax:SecondLargestCustomerMemberus-gaap:ProductConcentrationRiskMemberdvax:HEPLISAVBMember2021-01-012021-09-300001029142us-gaap:NonUsMember2020-07-012020-09-300001029142dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember2021-05-310001029142us-gaap:ConvertiblePreferredStockMember2021-01-012021-09-300001029142dvax:LoanAgreementMember2021-05-012021-05-310001029142us-gaap:EmployeeStockOptionMember2021-07-012021-09-300001029142dvax:UnvestedMember2021-01-012021-09-300001029142us-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142stpr:CAdvax:PowellStreetSubleaseMember2021-01-012021-06-300001029142dvax:CpG1018Member2020-12-310001029142us-gaap:NonUsMember2020-01-012020-09-300001029142us-gaap:RetainedEarningsMember2021-09-300001029142dvax:HortonStreetMasterLeaseMember2021-09-300001029142us-gaap:AdditionalPaidInCapitalMember2020-12-310001029142us-gaap:CommonStockMember2019-12-310001029142dvax:USDepartmentOfDefenseMember2021-01-012021-09-300001029142dvax:CRGServicingLLCMember2021-04-012021-06-300001029142dvax:AssetPurchaseAgreementMember2021-01-012021-09-300001029142dvax:PerformanceBasedRestrictedStockUnitsMember2021-01-012021-09-300001029142dvax:CpG1018Member2020-07-012020-09-300001029142country:USdvax:HEPLISAVBMember2021-01-012021-09-300001029142us-gaap:RestrictedStockUnitsRSUMember2020-12-310001029142us-gaap:WarrantMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-3100010291422019-08-012019-08-310001029142dvax:SeriesBConvertiblePreferredStockMember2019-08-012019-08-310001029142us-gaap:InventoriesMember2021-01-012021-09-300001029142us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142us-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:AvailableforsaleSecuritiesMember2020-12-310001029142us-gaap:SalesRevenueNetMemberdvax:LargestCustomerMemberdvax:HEPLISAVBMemberus-gaap:ProductConcentrationRiskMember2021-01-012021-09-300001029142dvax:HEPLISAVBMember2020-12-310001029142us-gaap:NonUsMemberdvax:OtherRevenueMember2021-01-012021-09-300001029142us-gaap:CorporateDebtSecuritiesMemberus-gaap:AvailableforsaleSecuritiesMember2021-09-300001029142srt:MaximumMember2020-08-062020-08-060001029142us-gaap:InventoriesMember2020-07-012020-09-300001029142country:USdvax:HEPLISAVBMember2020-01-012020-09-300001029142us-gaap:SalesRevenueNetMemberdvax:CpG1018Memberdvax:LargestCollaborationPartnerMemberus-gaap:ProductConcentrationRiskMember2021-07-012021-09-300001029142us-gaap:NonUsMemberdvax:HEPLISAVBMember2021-01-012021-09-300001029142srt:MaximumMemberdvax:TwentySeventeenAtTheMarketAgreementMember2017-11-030001029142dvax:AssetPurchaseAgreementMember2020-12-310001029142us-gaap:SubsequentEventMember2021-10-012021-10-310001029142dvax:ZhejiangCloverBiopharmaceuticalsIncAndCloverHongKongIncMember2021-09-300001029142us-gaap:FairValueInputsLevel3Member2021-01-012021-09-300001029142us-gaap:CommonStockMember2020-07-012020-09-3000010291422021-07-012021-09-300001029142us-gaap:WarrantMembersrt:MinimumMember2021-01-012021-09-300001029142stpr:CAus-gaap:OtherNonoperatingIncomeExpenseMemberdvax:HortonStreetSubleaseMember2020-07-012020-09-300001029142stpr:CAdvax:PowellStreetSubleaseMember2021-01-012021-09-300001029142us-gaap:SalesRevenueNetMemberdvax:LargestCustomerMemberdvax:HEPLISAVBMemberus-gaap:ProductConcentrationRiskMember2020-01-012020-09-300001029142us-gaap:EmployeeStockOptionMember2021-01-012021-09-300001029142us-gaap:WarrantMemberus-gaap:OtherNonoperatingIncomeExpenseMember2020-01-012020-09-300001029142dvax:SupplyAgreementMemberdvax:MedigenVaccineBiologicsMember2021-04-012021-06-3000010291422019-12-310001029142dvax:SupplyAgreementMemberdvax:BiologicalELimitedMember2021-01-012021-09-300001029142us-gaap:CommonStockMember2020-12-310001029142us-gaap:SalesRevenueNetMemberdvax:ThirdLargestCustomerMemberdvax:HEPLISAVBMemberus-gaap:ProductConcentrationRiskMember2021-07-012021-09-300001029142us-gaap:CostOfSalesMember2020-01-012020-09-300001029142us-gaap:CommonStockMember2021-07-012021-09-300001029142us-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142us-gaap:RetainedEarningsMember2020-07-012020-09-300001029142us-gaap:NonUsMemberdvax:OtherRevenueMember2020-01-012020-09-300001029142dvax:LoanAgreementMember2020-07-012020-09-300001029142us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142us-gaap:CommonStockMember2021-09-300001029142srt:MinimumMemberus-gaap:EmployeeStockOptionMember2021-07-012021-09-300001029142us-gaap:CostOfSalesMember2021-07-012021-09-300001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-09-300001029142dvax:ZhejiangCloverBiopharmaceuticalsIncAndCloverHongKongIncMember2020-12-310001029142us-gaap:ConvertibleNotesPayableMember2021-09-300001029142country:USus-gaap:ProductMember2021-01-012021-09-300001029142dvax:TrisalusLifeSciencesMember2021-09-012021-09-300001029142us-gaap:PreferredStockMember2020-12-310001029142dvax:TwoThousandAndFourteenEmployeeStockPurchasePlanMember2021-09-300001029142dvax:AssetPurchaseAgreementMember2021-07-012021-09-300001029142us-gaap:MoneyMarketFundsMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142us-gaap:SalesRevenueNetMemberdvax:ThirdLargestCustomerMemberus-gaap:ProductConcentrationRiskMemberdvax:HEPLISAVBMember2021-01-012021-09-300001029142us-gaap:SalesRevenueNetMemberdvax:CpG1018Memberdvax:SecondLargestCollaborationPartnerMemberus-gaap:ProductConcentrationRiskMember2021-01-012021-09-300001029142us-gaap:CommonStockMember2020-06-300001029142us-gaap:WarrantMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142srt:MinimumMemberus-gaap:EmployeeStockOptionMember2021-01-012021-09-300001029142dvax:SupplyAgreementMemberdvax:MedigenVaccineBiologicsMember2021-01-012021-03-310001029142us-gaap:FairValueInputsLevel2Memberus-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142country:USus-gaap:ProductMember2021-07-012021-09-300001029142us-gaap:CommonStockMember2021-08-310001029142dvax:CpG1018Member2020-01-012020-09-300001029142dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember2021-01-012021-09-300001029142us-gaap:CostOfSalesMember2021-01-012021-09-300001029142dvax:CoalitionForEpidemicPreparednessInnovationsMember2021-09-300001029142country:USus-gaap:ProductMember2020-01-012020-09-300001029142country:US2020-07-012020-09-300001029142us-gaap:AdditionalPaidInCapitalMember2021-09-300001029142us-gaap:NonUsMember2021-01-012021-09-300001029142dvax:OtherRevenueMember2021-07-012021-09-300001029142us-gaap:MoneyMarketFundsMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2020-12-310001029142us-gaap:InventoriesMember2020-01-012020-09-300001029142us-gaap:EmployeeStockOptionMember2020-07-012020-09-300001029142us-gaap:CashAndCashEquivalentsMemberus-gaap:CorporateDebtSecuritiesMember2020-12-310001029142us-gaap:SalesRevenueNetMemberdvax:ThirdLargestCustomerMemberdvax:HEPLISAVBMemberus-gaap:ProductConcentrationRiskMember2020-01-012020-09-300001029142us-gaap:CashAndCashEquivalentsMember2020-12-310001029142dvax:OtherRevenueMember2020-07-012020-09-300001029142us-gaap:SalesRevenueNetMemberdvax:CpG1018Memberdvax:LargestCollaborationPartnerMemberus-gaap:ProductConcentrationRiskMember2020-07-012020-09-300001029142dvax:SeriesBConvertiblePreferredStockMember2019-08-310001029142dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember2021-05-012021-05-310001029142dvax:OtherRevenueMember2021-01-012021-09-300001029142dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember2021-09-300001029142us-gaap:ProductMember2021-01-012021-09-3000010291422004-12-310001029142country:USdvax:HEPLISAVBMember2020-07-012020-09-300001029142dvax:ZhejiangCloverBiopharmaceuticalsIncAndCloverHongKongIncMemberdvax:SupplyAgreementMember2021-09-300001029142dvax:OtherRevenueMembercountry:US2021-01-012021-09-300001029142dvax:ConvertibleSeniorNotesMember2021-05-310001029142us-gaap:SalesRevenueNetMemberdvax:CpG1018Memberdvax:SecondLargestCollaborationPartnerMemberus-gaap:ProductConcentrationRiskMember2021-07-012021-09-300001029142us-gaap:NonUsMemberus-gaap:ProductMember2021-07-012021-09-300001029142dvax:VestedMember2021-01-012021-09-300001029142us-gaap:WarrantMemberus-gaap:OtherNonoperatingIncomeExpenseMember2021-07-012021-09-300001029142dvax:StockOptionsAndShareAwardsMember2020-07-012020-09-300001029142dvax:DusseldorfLeaseMembercountry:DE2021-09-012021-09-300001029142us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142us-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-09-300001029142us-gaap:AdditionalPaidInCapitalMember2021-07-012021-09-300001029142dvax:HEPLISAVBMember2020-01-012020-09-3000010291422021-09-300001029142us-gaap:SellingGeneralAndAdministrativeExpensesMember2020-01-012020-09-300001029142dvax:DebtInstrumentConversionPeriodTwoMembersrt:MaximumMemberdvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember2021-01-012021-09-300001029142us-gaap:ResearchAndDevelopmentExpenseMember2021-01-012021-09-3000010291422021-06-300001029142us-gaap:NonUsMemberdvax:OtherRevenueMember2021-07-012021-09-300001029142dvax:ZhejiangCloverBiopharmaceuticalsIncAndCloverHongKongIncMemberdvax:SupplyAgreementMember2021-07-012021-09-3000010291422020-06-300001029142us-gaap:ResearchAndDevelopmentExpenseMember2020-01-012020-09-300001029142dvax:MarketBasedPerformanceStockUnitMember2021-01-012021-09-300001029142dvax:SupplyAgreementMemberdvax:BiologicalELimitedMember2021-07-012021-09-300001029142stpr:CAus-gaap:OtherNonoperatingIncomeExpenseMemberdvax:HortonStreetSubleaseMember2021-07-012021-09-300001029142us-gaap:WarrantMember2021-09-300001029142country:US2021-07-012021-09-300001029142us-gaap:AccountsReceivableMemberdvax:HEPLISAVBMember2021-09-300001029142us-gaap:FairValueInputsLevel3Member2021-09-300001029142dvax:ConvertibleOptionalSeniorNotesMember2021-05-310001029142us-gaap:AdditionalPaidInCapitalMember2021-06-300001029142us-gaap:PreferredStockMember2021-06-300001029142us-gaap:WarrantMemberus-gaap:OtherNonoperatingIncomeExpenseMember2021-01-012021-09-300001029142dvax:CpG1018Memberdvax:LongTermDeferredRevenueMember2021-01-012021-09-300001029142us-gaap:AdditionalPaidInCapitalMember2019-12-310001029142us-gaap:USTreasurySecuritiesMemberus-gaap:AvailableforsaleSecuritiesMember2020-12-310001029142us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-09-30iso4217:EURxbrli:pureutr:sqftxbrli:sharesutr:Ddvax:Segmentiso4217:USDiso4217:USDxbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2021

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: 001-34207

 

Dynavax Technologies Corporation

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

33-0728374

(State or other jurisdiction of
incorporation or organization)

 

(IRS Employer
Identification No.)

2100 Powell Street, Suite 900

Emeryville, CA 94608

(510) 848-5100

(Address, including Zip Code, and telephone number, including area code, of the registrant’s principal executive offices)

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

Title of each class:

Trading symbol(s):

Name of each exchange on which registered:

Common Stock, $0.001 par value

DVAX

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registration 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 the definitions of “large accelerated filer”, “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

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 Act). Yes ☐ No

As of November 1, 2021, the registrant had outstanding 119,952,132 shares of common stock.

 

 


 

INDEX

DYNAVAX TECHNOLOGIES CORPORATION

 

 

Page No.

PART I FINANCIAL INFORMATION

 

 

Item 1.

Financial Statements (unaudited)

7

 

Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020

7

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2021 and 2020

8

 

Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2021 and 2020

9

 

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2021 and 2020

10

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020

11

 

Notes to Condensed Consolidated Financial Statements

12

Item 2.

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

33

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

42

Item 4.

Controls and Procedures

42

 

PART II OTHER INFORMATION

 

 

Item 1.

Legal Proceedings

43

Item 1A.

Risk Factors

43

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

66

Item 5.

Other Information

66

Item 6.

Exhibits

67

 

SIGNATURES

69

 

 

2


 

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements, including statements about the direct and indirect impact of the ongoing COVID-19 global pandemic on our business and operations, including sales of HEPLISAV-B®, our ability to successfully commercialize HEPLISAV-B, our anticipated market opportunity and level of sales of HEPLISAV-B, our ability to manufacture sufficient supply of HEPLISAV-B to meet future demand, our business, collaboration and regulatory strategy, our ability to successfully support the development, manufacture and commercialization of other vaccines containing our CpG 1018® adjuvant, including any potential vaccine for COVID-19 stemming from our multiple collaborations, our ability to manufacture sufficient supply of CpG 1018 to meet potential future demand in connection with new vaccines, and to meet regulatory requirements, uncertainty regarding our capital needs and future operating results and profitability, anticipated sources of funds, liquidity and cash needs, as well as our plans, objectives, strategies, expectations and intentions. These statements appear throughout this Quarterly Report on Form 10-Q and can be identified by the use of forward-looking language such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “future,” or “intend,” or the negative of these terms or other variations or comparable terminology.

Actual results may vary materially from those in our forward-looking statements as a result of various factors that are identified in “Item 1A—Risk Factors” and “Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this document. No assurance can be given that the risk factors described in this Quarterly Report on Form 10-Q are all of the factors that could cause actual results to vary materially from the forward-looking statements. All forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. Readers should not place undue reliance on these forward-looking statements and are cautioned that any such forward-looking statements are not guarantees of future performance. We assume no obligation to update any forward-looking statements.

This Quarterly Report on Form 10-Q includes trademarks and registered trademarks of Dynavax Technologies Corporation. Products or service names of other companies mentioned in this Quarterly Report on Form 10-Q may be trademarks or registered trademarks of their respective owners. References herein to “we,” “our,” “us,” “Dynavax” or the “Company” refer to Dynavax Technologies Corporation and its subsidiaries.

 

 

 

3


 

RISK FACTOR SUMMARY

Below is a summary of material factors that make an investment in our securities speculative or risky. Importantly, this summary does not address all of the risks and uncertainties that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found in the more detailed discussion that follows this summary, and the below summary is qualified in its entirety by that more complete discussion of such risks and uncertainties. You should consider carefully the risks and uncertainties described herein as part of your evaluation of an investment in our securities:

HEPLISAV-B has been launched in the United States, and approved in the European Union, and there is significant competition in these marketplaces. Since this is our first marketed product, the timing of uptake and distribution efforts are unpredictable and there is a risk that we may not achieve and sustain commercial success for HEPLISAV-B.
Our business and operations have been and may continue to be adversely affected by the evolving and ongoing COVID-19 global pandemic. While we have entered into collaborative relationships to develop vaccines utilizing our CpG 1018 adjuvant, including collaborations to develop a vaccine for COVID-19, our collaborators generally have primary responsibility for the development, conduct of clinical trials, for seeking and obtaining regulatory approval, and for the manufacture and commercialization of any approved vaccine, and these collaborations may not be successful. If the combination of patents, trade secrets and other proprietary rights that we rely on to protect our intellectual property rights in CpG 1018 adjuvant are inadequate; we may be unable to realize any commercial benefit from the development of a vaccine containing CpG 1018 adjuvant.
Our financial results may vary significantly from quarter to quarter or may fall below the expectations of investors or securities analysts, each of which may adversely affect our stock price.
We face uncertainty regarding coverage, pricing and reimbursement and the practices of third-party payors, which may make it difficult or impossible to sell our products or product candidates on commercially reasonable terms.
We are subject to ongoing United States Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) post-marketing obligations concerning HEPLISAV-B, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated regulatory issues with HEPLISAV-B.
If HEPLISAV-B or any products we develop are not accepted by the market or if regulatory agencies limit our labeling indications, require labeling content that diminishes market uptake of HEPLISAV-B or any other products we develop, or limit our marketing claims, we may be unable to generate significant revenues, if any.
Many of our competitors have greater financial resources and expertise than we do. If we are unable to successfully compete with existing or potential competitors as a result of these disadvantages, we may be unable to generate sufficient or any revenues and our business will be harmed.
Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt. Conversion of the Convertible Notes (defined below) may dilute the ownership interest of our stockholders or may otherwise depress the price of our common stock.
Despite recent profitability, we have incurred annual net losses in each year since our inception and anticipate that we could continue to incur significant losses for the foreseeable future unless we can successfully commercialize HEPLISAV-B and/or continue to sell significant quantities of our CpG 1018 adjuvant, and if we are unable to sustain profitability, the market value of our common stock will likely decline. Until we are able to generate significant revenues or achieve profitability through product sales on a consistent basis, we could require substantial additional capital to finance our operations.
We may develop, seek regulatory approval for and market HEPLISAV-B or any other product candidates we may develop outside the U.S., requiring a significant commitment of resources. Failure to successfully manage our international operations could result in significant unanticipated costs and delays in regulatory approval or commercialization of our product and product candidates.
Clinical trials for our commercial product and product candidates are expensive and time consuming, may take longer than we expect or may not be completed at all, and their outcomes are uncertain.
As a biopharmaceutical company, we engage clinical research organizations (“CROs”) to conduct clinical studies, and failure by us or our CROs to conduct a clinical study in accordance with good clinical practice standards and other applicable regulatory requirements could result in disqualification of the applicable clinical trial from consideration in support of approval of a potential product.

 

4


 

Regulatory authorities may require more clinical trials for our product candidates than we currently expect or are conducting before granting regulatory approval, if regulatory approval is granted at all. Our clinical trials may be extended which may lead to substantial delays in the regulatory approval process for our product candidates and may impair our ability to generate revenues.
HEPLISAV-B and most of our earlier stage programs, including our CpG 1018 adjuvant, rely on oligonucleotide toll-like receptor (“TLR”) agonists. Serious adverse event data relating to TLR agonists may require us to reduce the scope of or discontinue our operations, or reevaluate the viability of strategic alternatives.
As we plan for broader commercialization of HEPLISAV-B and for expanded capacity to manufacture our CpG 1018 adjuvant, our financial commitments to increase supply capacity might outpace actual demand for our products. Also, if we are unable to maintain our production operations in Dusseldorf and our existing supplier for CpG 1018 adjuvant, we would have to establish alternate qualified manufacturing capabilities, which could result in significant additional operating costs and delays in developing and commercializing HEPLISAV-B and any approved or potential vaccine utilizing CpG 1018. There can be no assurance that we or other third parties will be able to produce CpG 1018 at a cost, quantity and quality sufficient to support our existing or any future collaborations.
We rely on our facility in Düsseldorf, Germany and third parties to supply materials or perform processes necessary to manufacture HEPLISAV-B. We rely on a limited number of suppliers to produce the oligonucleotides we require for development and commercialization. Additionally, we and our collaborators have limited experience in manufacturing our products and product candidates in commercial quantities. With respect to HEPLISAV-B, we use a pre-filled syringe presentation of the vaccine and our ability to meet future demand will depend on our or our contract manufacturer's ability to provide sufficient supply in this presentation.
As we continue to grow as a commercial organization and enter into supply agreements with customers and collaborators, those supply agreements will have obligations to deliver product for which we are reliant upon third parties to manufacture on our behalf.
HEPLISAV-B is subject to regulatory obligations and continued regulatory review, and if we receive regulatory approval for our other product candidates, we will be subject to ongoing FDA and foreign regulatory obligations and continued regulatory review for such products.
A key part of our business strategy for products in development is to establish collaborative relationships to help fund or manage development and commercialization of our product candidates and research programs. We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to continue to develop and commercialize those products and programs, if at all.
We rely on CROs and clinical sites and investigators for our clinical trials. If these third parties do not fulfill their contractual obligations or meet expected deadlines, our planned clinical trials may be delayed and we may fail to obtain the regulatory approvals necessary to commercialize our product candidates.
As we focus on commercialization of HEPLISAV-B, we may encounter difficulties in managing our commercial growth and expanding our operations successfully.
If we fail to comply with the extensive requirements applicable to biopharmaceutical manufacturers and marketers under the healthcare fraud and abuse, anticorruption, privacy, transparency and other laws of the jurisdictions in which we conduct our business, we may be subject to significant liability.
The loss of key personnel could delay or prevent achieving our objectives. In addition, our continued growth to support commercialization may result in difficulties in managing our growth and expanding our operations successfully.
We face product liability exposure, which, if not covered by insurance, could result in significant financial liability. Our business operations are vulnerable to interruptions by natural disasters, health epidemics and other catastrophic events beyond our control, the occurrence of which could materially harm our manufacturing, distribution, sales, business operations and financial results. Significant disruptions of information technology systems or breaches of data security could also adversely affect our business.
We rely on licenses to intellectual property from third parties. Impairment of these licenses or our inability to maintain them would severely harm our business.

 

5


 

If third parties successfully assert that we have infringed their patents and proprietary rights or challenge our patents and proprietary rights, we may become involved in intellectual property disputes and litigation that would be costly, time consuming and delay or prevent development or commercialization of our product candidates.
Future sales of our common stock or the perception that such sales may occur in the public market could cause our stock price to fall.

 

 

6


 

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

Dynavax Technologies Corporation

Condensed Consolidated Balance Sheets

(In thousands, except per share amounts)

 

 

September 30,

 

 

December 31,

 

 

2021

 

 

2020

 

 

(unaudited)

 

 

(Note 1)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

246,351

 

 

$

32,073

 

Marketable securities available-for-sale

 

167,804

 

 

 

132,963

 

Accounts and other receivables, net

 

200,362

 

 

 

22,661

 

Inventories, net

 

67,297

 

 

 

63,689

 

Prepaid manufacturing

 

109,763

 

 

 

29,423

 

Prepaid expenses and other current assets

 

61,093

 

 

 

9,206

 

Total current assets

 

852,670

 

 

 

290,015

 

Property and equipment, net

 

34,251

 

 

 

30,567

 

Operating lease right-of-use assets

 

26,772

 

 

 

26,583

 

Goodwill

 

2,171

 

 

 

2,297

 

Restricted cash

 

224

 

 

 

237

 

Other assets

 

3,623

 

 

 

3,573

 

Total assets

$

919,711

 

 

$

353,272

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

3,596

 

 

$

3,312

 

Accrued research and development

 

3,935

 

 

 

2,805

 

Accrued liabilities

 

87,910

 

 

 

19,099

 

Warrant liability

 

72,017

 

 

 

10,736

 

Deferred revenue

 

358,588

 

 

 

38,212

 

Other current liabilities

 

2,889

 

 

 

3,247

 

Total current liabilities

 

528,935

 

 

 

77,411

 

Long-term debt, net of debt discount of $1,094 at December 31, 2020

 

-

 

 

 

179,811

 

Convertible Notes, net of debt discount of $5,277 at September 30, 2021 (see Note 7)

 

220,223

 

 

 

-

 

Long-term deferred revenue

 

67,969

 

 

 

-

 

Long-term portion of lease liabilities

 

34,929

 

 

 

34,789

 

Other long-term liabilities

 

79

 

 

 

2,568

 

Total liabilities

 

852,135

 

 

 

294,579

 

Commitments and contingencies (Note 5)

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock: $0.001 par value

 

 

 

 

 

Authorized: 5,000 shares; Issued and outstanding:

 

-

 

 

 

-

 

Series B Convertible Preferred stock ̶ no shares and 4 shares at September 30, 2021
   and December 31, 2020, respectively

 

-

 

 

 

-

 

Common stock: $0.001 par value; 278,000 shares authorized at
   September 30, 2021 and December 31, 2020;
119,787 shares and 110,190
   shares issued and outstanding at September 30, 2021 and December 31, 2020,
   respectively

 

120

 

 

 

110

 

Additional paid-in capital

 

1,386,114

 

 

 

1,352,374

 

Accumulated other comprehensive (loss) gain

 

(1,528

)

 

 

273

 

Accumulated deficit

 

(1,317,130

)

 

 

(1,294,064

)

Total stockholders’ equity

 

67,576

 

 

 

58,693

 

Total liabilities and stockholders’ equity

$

919,711

 

 

$

353,272

 

 

See accompanying notes.

 

7


 

Dynavax Technologies Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

106,996

 

 

$

13,276

 

 

$

242,558

 

 

$

26,195

 

Other revenue

 

 

1,274

 

 

 

138

 

 

 

1,814

 

 

 

806

 

Total revenues

 

 

108,270

 

 

 

13,414

 

 

 

244,372

 

 

 

27,001

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales - product

 

 

60,090

 

 

 

4,031

 

 

 

99,560

 

 

 

7,352

 

Cost of sales - amortization of intangible assets

 

 

-

 

 

 

-

 

 

 

-

 

 

 

2,500

 

Research and development

 

 

6,186

 

 

 

8,521

 

 

 

21,111

 

 

 

19,058

 

Selling, general and administrative

 

 

26,926

 

 

 

21,538

 

 

 

70,932

 

 

 

61,418

 

Gain on sale of assets (Note 5)

 

 

(1,000

)

 

 

(6,851

)

 

 

(1,000

)

 

 

(6,851

)

Total operating expenses

 

 

92,202

 

 

 

27,239

 

 

 

190,603

 

 

 

83,477

 

Income (loss) from operations

 

 

16,068

 

 

 

(13,825

)

 

 

53,769

 

 

 

(56,476

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

39

 

 

 

269

 

 

 

134

 

 

 

1,190

 

Interest expense

 

 

(1,676

)

 

 

(4,794

)

 

 

(9,497

)

 

 

(14,257

)

Sublease income

 

 

2,022

 

 

 

1,926

 

 

 

5,714

 

 

 

5,779

 

Loss on debt extinguishment (Note 8)

 

 

-

 

 

 

-

 

 

 

(5,232

)

 

 

-

 

Change in fair value of warrant liability (Note 11)

 

 

(45,121

)

 

 

21,245

 

 

 

(68,576

)

 

 

4,200

 

Other

 

 

238

 

 

 

(420

)

 

 

622

 

 

 

(209

)

Net (loss) income

 

 

(28,430

)

 

 

4,401

 

 

 

(23,066

)

 

 

(59,773

)

Net (loss) income per share attributable to common stockholders

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.24

)

 

$

0.04

 

 

$

(0.20

)

 

$

(0.61

)

Diluted

 

$

(0.24

)

 

$

(0.15

)

 

$

(0.20

)

 

$

(0.65

)

Weighted-average shares used in computing net (loss) income per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

116,903

 

 

 

109,816

 

 

 

114,540

 

 

 

97,589

 

Diluted

 

 

116,903

 

 

 

111,973

 

 

 

114,540

 

 

 

98,577

 

 

 

8


 

Condensed Consolidated Statements of Comprehensive Loss

(In thousands)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net (loss) income

 

$

(28,430

)

 

$

4,401

 

 

$

(23,066

)

 

$

(59,773

)

Other comprehensive (loss) income, net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

Reclassification of realized gain on available-for-sale securities
   recognized in interest income

 

 

-

 

 

 

(108

)

 

 

-

 

 

 

(21

)

Change in unrealized gain (loss) on marketable securities available-
   for-sale

 

 

(18

)

 

 

(75

)

 

 

11

 

 

 

30

 

Foreign currency translation adjustments

 

 

(797

)

 

 

1,256

 

 

 

(1,812

)

 

 

1,356

 

Total other comprehensive (loss) income

 

 

(815

)

 

 

1,073

 

 

 

(1,801

)

 

 

1,365

 

Total comprehensive (loss) income

 

$

(29,245

)

 

$

5,474

 

 

$

(24,867

)

 

$

(58,408

)

 

See accompanying notes.

 

 

 

9


 

Dynavax Technologies Corporation

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands)

(Unaudited)

 

 

 

Common Stock

 

 

Preferred Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

Three Months Ended September 30, 2021

 

Shares

 

 

Par Amount

 

 

Shares

 

 

Par Amount

 

 

Capital

 

 

(Loss) Income

 

 

Deficit

 

 

Equity

 

Balances at June 30, 2021

 

 

114,756

 

 

$

114

 

 

 

4

 

 

$

-

 

 

$

1,372,679

 

 

$

(713

)

 

$

(1,288,700

)

 

$

83,380

 

Issuance of common stock upon exercise of stock options and restricted stock awards, net

 

 

582

 

 

 

2

 

 

 

-

 

 

 

-

 

 

 

3,980

 

 

 

-

 

 

 

-

 

 

 

3,982

 

Issuance of common stock upon exercise of warrants

 

 

196

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

3,625

 

 

 

-

 

 

 

-

 

 

 

3,625

 

Conversion of preferred stock

 

 

4,140

 

 

 

4

 

 

 

(4

)

 

 

-

 

 

 

(4

)

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock under Employee Stock Purchase Plan

 

 

113

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

458

 

 

 

-

 

 

 

-

 

 

 

458

 

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,376

 

 

 

-

 

 

 

-

 

 

 

5,376

 

Total other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(815

)

 

 

-

 

 

 

(815

)

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(28,430

)

 

 

(28,430

)

Balances at September 30, 2021

 

 

119,787

 

 

$

120

 

 

 

-

 

 

$

-

 

 

$

1,386,114

 

 

$

(1,528

)

 

$

(1,317,130

)

 

$

67,576

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at December 31, 2020

 

 

110,190

 

 

$

110

 

 

 

4

 

 

$

-

 

 

$

1,352,374

 

 

$

273

 

 

$

(1,294,064

)

 

$

58,693

 

Issuance of common stock upon exercise of stock options and restricted stock awards, net

 

 

1,415

 

 

 

2

 

 

 

-

 

 

 

-

 

 

 

5,315

 

 

 

-

 

 

 

-

 

 

 

5,317

 

Issuance of common stock upon exercise of warrants

 

 

946

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

11,552

 

 

 

-

 

 

 

-

 

 

 

11,553

 

Conversion of preferred stock

 

 

4,140

 

 

 

4

 

 

 

(4

)

 

 

-

 

 

 

(4

)

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock under Employee Stock Purchase Plan

 

 

217

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

841

 

 

 

-

 

 

 

-

 

 

 

841

 

Issuance of common stock, net of issuance costs, in conjunction with an At Market Sales
   Agreement (see Note 11)

 

 

2,879

 

 

 

3

 

 

 

-

 

 

 

-

 

 

 

28,153

 

 

 

-

 

 

 

-

 

 

 

28,156

 

Issuance of capped call options

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(27,240

)

 

 

-

 

 

 

-

 

 

 

(27,240

)

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

15,123

 

 

 

-

 

 

 

-

 

 

 

15,123

 

Total other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,801

)

 

 

-

 

 

 

(1,801

)

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(23,066

)