dvax-10q_20210630.htm
false Q2 0001029142 --12-31 false false P5Y P4Y P3Y P4Y4M9D P4Y3M14D P3Y10D 0.0003 P4Y6M P4Y6M P4Y6M P4Y6M P2Y10M24D 0.0192 0001029142 2021-01-01 2021-06-30 xbrli:shares 0001029142 2021-07-30 iso4217:USD 0001029142 2021-06-30 0001029142 2020-12-31 0001029142 dvax:SeriesBConvertiblePreferredStockMember 2021-06-30 0001029142 dvax:SeriesBConvertiblePreferredStockMember 2020-12-31 0001029142 us-gaap:ConvertibleNotesPayableMember 2021-06-30 iso4217:USD xbrli:shares 0001029142 us-gaap:ProductMember 2021-04-01 2021-06-30 0001029142 us-gaap:ProductMember 2020-04-01 2020-06-30 0001029142 us-gaap:ProductMember 2021-01-01 2021-06-30 0001029142 us-gaap:ProductMember 2020-01-01 2020-06-30 0001029142 dvax:OtherRevenueMember 2021-04-01 2021-06-30 0001029142 dvax:OtherRevenueMember 2020-04-01 2020-06-30 0001029142 dvax:OtherRevenueMember 2021-01-01 2021-06-30 0001029142 dvax:OtherRevenueMember 2020-01-01 2020-06-30 0001029142 2021-04-01 2021-06-30 0001029142 2020-04-01 2020-06-30 0001029142 2020-01-01 2020-06-30 0001029142 us-gaap:CommonStockMember 2021-03-31 0001029142 us-gaap:PreferredStockMember 2021-03-31 0001029142 us-gaap:AdditionalPaidInCapitalMember 2021-03-31 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-03-31 0001029142 us-gaap:RetainedEarningsMember 2021-03-31 0001029142 2021-03-31 0001029142 us-gaap:CommonStockMember 2021-04-01 2021-06-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2021-04-01 2021-06-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-04-01 2021-06-30 0001029142 us-gaap:RetainedEarningsMember 2021-04-01 2021-06-30 0001029142 us-gaap:CommonStockMember 2021-06-30 0001029142 us-gaap:PreferredStockMember 2021-06-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2021-06-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-06-30 0001029142 us-gaap:RetainedEarningsMember 2021-06-30 0001029142 us-gaap:CommonStockMember 2020-12-31 0001029142 us-gaap:PreferredStockMember 2020-12-31 0001029142 us-gaap:AdditionalPaidInCapitalMember 2020-12-31 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-12-31 0001029142 us-gaap:RetainedEarningsMember 2020-12-31 0001029142 us-gaap:CommonStockMember 2021-01-01 2021-06-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2021-01-01 2021-06-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-01-01 2021-06-30 0001029142 us-gaap:RetainedEarningsMember 2021-01-01 2021-06-30 0001029142 us-gaap:CommonStockMember 2020-03-31 0001029142 us-gaap:PreferredStockMember 2020-03-31 0001029142 us-gaap:AdditionalPaidInCapitalMember 2020-03-31 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-03-31 0001029142 us-gaap:RetainedEarningsMember 2020-03-31 0001029142 2020-03-31 0001029142 us-gaap:CommonStockMember 2020-04-01 2020-06-30 0001029142 us-gaap:PreferredStockMember 2020-04-01 2020-06-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2020-04-01 2020-06-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-04-01 2020-06-30 0001029142 us-gaap:RetainedEarningsMember 2020-04-01 2020-06-30 0001029142 us-gaap:CommonStockMember 2020-06-30 0001029142 us-gaap:PreferredStockMember 2020-06-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2020-06-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-06-30 0001029142 us-gaap:RetainedEarningsMember 2020-06-30 0001029142 2020-06-30 0001029142 us-gaap:CommonStockMember 2019-12-31 0001029142 us-gaap:PreferredStockMember 2019-12-31 0001029142 us-gaap:AdditionalPaidInCapitalMember 2019-12-31 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-12-31 0001029142 us-gaap:RetainedEarningsMember 2019-12-31 0001029142 2019-12-31 0001029142 us-gaap:CommonStockMember 2020-01-01 2020-06-30 0001029142 us-gaap:PreferredStockMember 2020-01-01 2020-06-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2020-01-01 2020-06-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-01-01 2020-06-30 0001029142 us-gaap:RetainedEarningsMember 2020-01-01 2020-06-30 0001029142 dvax:HEPLISAVBMember 2021-01-01 2021-06-30 0001029142 dvax:CpG1018Member 2021-01-01 2021-06-30 0001029142 dvax:HEPLISAVBMember 2021-01-01 2021-06-30 dvax:Segment 0001029142 dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember 2021-06-30 xbrli:pure 0001029142 dvax:LoanAgreementMember 2021-01-01 2021-06-30 0001029142 dvax:CappedCallsMember 2021-01-01 2021-06-30 0001029142 srt:MaximumMember 2021-01-01 2021-06-30 0001029142 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:WarrantMember us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:WarrantMember us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0001029142 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:FairValueMeasurementsRecurringMember 2019-12-31 0001029142 us-gaap:WarrantMember us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2020-12-31 0001029142 us-gaap:WarrantMember us-gaap:FairValueMeasurementsRecurringMember 2020-12-31 0001029142 us-gaap:FairValueInputsLevel3Member 2021-06-30 0001029142 us-gaap:FairValueInputsLevel3Member 2020-12-31 0001029142 us-gaap:FairValueInputsLevel3Member 2021-01-01 2021-06-30 0001029142 us-gaap:FairValueInputsLevel2Member 2021-06-30 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:CashMember 2021-06-30 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:MoneyMarketFundsMember 2021-06-30 0001029142 us-gaap:CashAndCashEquivalentsMember 2021-06-30 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:USTreasurySecuritiesMember 2021-06-30 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2021-06-30 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:CorporateDebtSecuritiesMember 2021-06-30 0001029142 us-gaap:AvailableforsaleSecuritiesMember 2021-06-30 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:CashMember 2020-12-31 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:MoneyMarketFundsMember 2020-12-31 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:CorporateDebtSecuritiesMember 2020-12-31 0001029142 us-gaap:CashAndCashEquivalentsMember 2020-12-31 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:USTreasurySecuritiesMember 2020-12-31 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2020-12-31 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:CorporateDebtSecuritiesMember 2020-12-31 0001029142 us-gaap:AvailableforsaleSecuritiesMember 2020-12-31 utr:sqft 0001029142 stpr:CA dvax:PowellStreetSubleaseMember 2019-07-31 0001029142 stpr:CA dvax:PowellStreetSubleaseMember 2019-07-01 2019-07-31 0001029142 stpr:CA dvax:PowellStreetSubleaseMember 2021-01-01 2021-06-30 0001029142 stpr:CA dvax:HortonStreetMasterLeaseMember 2018-09-17 0001029142 stpr:CA dvax:HortonStreetMasterLeaseMember 2018-09-16 2018-09-17 0001029142 dvax:HortonStreetSubleaseMember stpr:CA 2019-07-31 0001029142 dvax:HortonStreetSubleaseMember stpr:CA 2019-07-01 2019-07-31 0001029142 dvax:HortonStreetSubleaseMember us-gaap:OtherNonoperatingIncomeExpenseMember stpr:CA 2021-04-01 2021-06-30 0001029142 dvax:HortonStreetSubleaseMember us-gaap:OtherNonoperatingIncomeExpenseMember stpr:CA 2021-01-01 2021-06-30 0001029142 dvax:HortonStreetSubleaseMember us-gaap:OtherNonoperatingIncomeExpenseMember stpr:CA 2020-04-01 2020-06-30 0001029142 dvax:HortonStreetSubleaseMember us-gaap:OtherNonoperatingIncomeExpenseMember stpr:CA 2020-01-01 2020-06-30 0001029142 dvax:HortonStreetMasterLeaseMember 2021-06-30 0001029142 dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember 2021-01-01 2021-06-30 iso4217:EUR 0001029142 2004-12-31 0001029142 dvax:SymphonyDynamoHoldingsLlcMember 2009-11-30 0001029142 dvax:SymphonyDynamoHoldingsLlcMember 2009-11-01 2009-11-30 0001029142 2020-08-01 2020-08-31 0001029142 dvax:SymphonyDynamoHoldingsLlcMember dvax:AssetPurchaseAgreementMember 2021-06-30 0001029142 dvax:CoalitionForEpidemicPreparednessInnovationsMember 2021-01-31 0001029142 dvax:CoalitionForEpidemicPreparednessInnovationsMember dvax:ReservationAgreementMember 2021-05-02 2021-05-03 0001029142 dvax:CoalitionForEpidemicPreparednessInnovationsMember dvax:ReservationAgreementMember 2021-05-03 0001029142 dvax:CoalitionForEpidemicPreparednessInnovationsMember 2021-06-30 0001029142 dvax:ZhejiangCloverBiopharmaceuticalsIncAndCloverHongKongIncMember dvax:SupplyAgreementMember 2021-06-30 0001029142 dvax:SupplyAgreementMember dvax:MedigenVaccineBiologicsMember 2021-04-01 2021-06-30 0001029142 dvax:SupplyAgreementMember dvax:MedigenVaccineBiologicsMember 2021-01-01 2021-06-30 0001029142 dvax:SupplyAgreementMember dvax:ValnevaSEMember 2021-06-30 0001029142 dvax:SupplyAgreementMember dvax:ValnevaSEMember 2021-04-01 2021-06-30 0001029142 dvax:SupplyAgreementMember dvax:ValnevaSEMember 2021-01-01 2021-06-30 0001029142 dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember 2021-05-31 0001029142 dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember 2021-05-01 2021-05-31 0001029142 dvax:LoanAgreementMember 2021-05-01 2021-05-31 0001029142 dvax:CappedCallsMember 2021-05-01 2021-05-31 utr:D 0001029142 dvax:DebtInstrumentConversionPeriodOneMember dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember 2021-01-01 2021-06-30 0001029142 dvax:DebtInstrumentConversionPeriodTwoMember dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember 2021-01-01 2021-06-30 0001029142 dvax:DebtInstrumentConversionPeriodOneMember srt:MaximumMember dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember 2021-01-01 2021-06-30 0001029142 dvax:DebtInstrumentConversionPeriodTwoMember srt:MaximumMember dvax:ConvertibleSeniorNotesDueTwoThousandTwentySixMember 2021-01-01 2021-06-30 0001029142 dvax:CappedCallsMember 2021-06-30 0001029142 dvax:CRGServicingLLCMember 2018-02-20 0001029142 dvax:CRGServicingLLCMember 2019-03-29 0001029142 dvax:CRGServicingLLCMember 2018-02-19 2018-02-20 0001029142 dvax:CRGServicingLLCMember 2021-04-01 2021-06-30 0001029142 dvax:CRGServicingLLCMember 2021-01-01 2021-06-30 0001029142 dvax:LoanAgreementMember 2021-04-01 2021-06-30 0001029142 dvax:LoanAgreementMember 2020-04-01 2020-06-30 0001029142 dvax:LoanAgreementMember 2020-01-01 2020-06-30 0001029142 dvax:HEPLISAVBMember country:US 2021-04-01 2021-06-30 0001029142 dvax:HEPLISAVBMember 2021-04-01 2021-06-30 0001029142 dvax:HEPLISAVBMember country:US 2020-04-01 2020-06-30 0001029142 dvax:HEPLISAVBMember 2020-04-01 2020-06-30 0001029142 dvax:CpG1018Member us-gaap:NonUsMember 2021-04-01 2021-06-30 0001029142 dvax:CpG1018Member 2021-04-01 2021-06-30 0001029142 us-gaap:ProductMember country:US 2021-04-01 2021-06-30 0001029142 us-gaap:ProductMember us-gaap:NonUsMember 2021-04-01 2021-06-30 0001029142 us-gaap:ProductMember country:US 2020-04-01 2020-06-30 0001029142 dvax:OtherRevenueMember us-gaap:NonUsMember 2021-04-01 2021-06-30 0001029142 dvax:OtherRevenueMember us-gaap:NonUsMember 2020-04-01 2020-06-30 0001029142 country:US 2021-04-01 2021-06-30 0001029142 us-gaap:NonUsMember 2021-04-01 2021-06-30 0001029142 country:US 2020-04-01 2020-06-30 0001029142 us-gaap:NonUsMember 2020-04-01 2020-06-30 0001029142 dvax:HEPLISAVBMember country:US 2021-01-01 2021-06-30 0001029142 dvax:HEPLISAVBMember country:US 2020-01-01 2020-06-30 0001029142 dvax:HEPLISAVBMember 2020-01-01 2020-06-30 0001029142 dvax:CpG1018Member us-gaap:NonUsMember 2021-01-01 2021-06-30 0001029142 dvax:CpG1018Member 2021-01-01 2021-06-30 0001029142 us-gaap:ProductMember country:US 2021-01-01 2021-06-30 0001029142 us-gaap:ProductMember us-gaap:NonUsMember 2021-01-01 2021-06-30 0001029142 us-gaap:ProductMember country:US 2020-01-01 2020-06-30 0001029142 dvax:OtherRevenueMember country:US 2021-01-01 2021-06-30 0001029142 dvax:OtherRevenueMember us-gaap:NonUsMember 2021-01-01 2021-06-30 0001029142 dvax:OtherRevenueMember us-gaap:NonUsMember 2020-01-01 2020-06-30 0001029142 country:US 2021-01-01 2021-06-30 0001029142 us-gaap:NonUsMember 2021-01-01 2021-06-30 0001029142 country:US 2020-01-01 2020-06-30 0001029142 us-gaap:NonUsMember 2020-01-01 2020-06-30 0001029142 dvax:LargestCustomerMember dvax:HEPLISAVBMember 2021-04-01 2021-06-30 0001029142 dvax:LargestCustomerMember dvax:HEPLISAVBMember 2020-04-01 2020-06-30 0001029142 dvax:LargestCustomerMember dvax:HEPLISAVBMember 2021-01-01 2021-06-30 0001029142 dvax:LargestCustomerMember dvax:HEPLISAVBMember 2020-01-01 2020-06-30 0001029142 dvax:SecondLargestCustomerMember dvax:HEPLISAVBMember 2021-04-01 2021-06-30 0001029142 dvax:SecondLargestCustomerMember dvax:HEPLISAVBMember 2020-04-01 2020-06-30 0001029142 dvax:SecondLargestCustomerMember dvax:HEPLISAVBMember 2021-01-01 2021-06-30 0001029142 dvax:SecondLargestCustomerMember dvax:HEPLISAVBMember 2020-01-01 2020-06-30 0001029142 dvax:ThirdLargestCustomerMember dvax:HEPLISAVBMember 2021-04-01 2021-06-30 0001029142 dvax:ThirdLargestCustomerMember dvax:HEPLISAVBMember 2020-04-01 2020-06-30 0001029142 dvax:ThirdLargestCustomerMember dvax:HEPLISAVBMember 2021-01-01 2021-06-30 0001029142 dvax:ThirdLargestCustomerMember dvax:HEPLISAVBMember 2020-01-01 2020-06-30 0001029142 dvax:CpG1018Member dvax:LargestCollaborationPartnerMember 2021-04-01 2021-06-30 0001029142 dvax:CpG1018Member dvax:LargestCollaborationPartnerMember 2020-04-01 2020-06-30 0001029142 dvax:CpG1018Member dvax:LargestCollaborationPartnerMember 2021-01-01 2021-06-30 0001029142 dvax:CpG1018Member dvax:LargestCollaborationPartnerMember 2020-01-01 2020-06-30 0001029142 dvax:CpG1018Member dvax:SecondLargestCollaborationPartnerMember 2021-04-01 2021-06-30 0001029142 dvax:CpG1018Member dvax:SecondLargestCollaborationPartnerMember 2020-04-01 2020-06-30 0001029142 dvax:CpG1018Member dvax:SecondLargestCollaborationPartnerMember 2021-01-01 2021-06-30 0001029142 dvax:CpG1018Member dvax:SecondLargestCollaborationPartnerMember 2020-01-01 2020-06-30 0001029142 dvax:HEPLISAVBMember us-gaap:AccountsReceivableMember 2020-12-31 0001029142 dvax:HEPLISAVBMember 2020-12-31 0001029142 dvax:HEPLISAVBMember us-gaap:AccountsReceivableMember 2021-01-01 2021-06-30 0001029142 dvax:HEPLISAVBMember us-gaap:AccountsReceivableMember 2021-06-30 0001029142 dvax:HEPLISAVBMember 2021-06-30 0001029142 dvax:CpG1018Member 2020-12-31 0001029142 dvax:LongTermDeferredRevenueMember dvax:CpG1018Member 2021-01-01 2021-06-30 0001029142 dvax:CpG1018Member 2021-06-30 0001029142 dvax:LongTermDeferredRevenueMember dvax:CpG1018Member 2021-06-30 0001029142 dvax:StockOptionsAndShareAwardsMember 2021-04-01 2021-06-30 0001029142 dvax:StockOptionsAndShareAwardsMember 2020-04-01 2020-06-30 0001029142 dvax:StockOptionsAndShareAwardsMember 2021-01-01 2021-06-30 0001029142 dvax:StockOptionsAndShareAwardsMember 2020-01-01 2020-06-30 0001029142 us-gaap:ConvertiblePreferredStockMember 2021-04-01 2021-06-30 0001029142 us-gaap:ConvertiblePreferredStockMember 2020-04-01 2020-06-30 0001029142 us-gaap:ConvertiblePreferredStockMember 2021-01-01 2021-06-30 0001029142 us-gaap:ConvertiblePreferredStockMember 2020-01-01 2020-06-30 0001029142 us-gaap:WarrantMember 2020-04-01 2020-06-30 0001029142 us-gaap:WarrantMember 2021-01-01 2021-06-30 0001029142 us-gaap:WarrantMember 2020-01-01 2020-06-30 0001029142 us-gaap:ConvertibleNotesPayableMember 2021-04-01 2021-06-30 0001029142 us-gaap:ConvertibleNotesPayableMember 2021-01-01 2021-06-30 0001029142 2019-08-01 2019-08-31 0001029142 2019-08-31 0001029142 dvax:SeriesBConvertiblePreferredStockMember 2019-08-01 2019-08-31 0001029142 dvax:SeriesBConvertiblePreferredStockMember 2019-08-31 0001029142 srt:MaximumMember us-gaap:IPOMember 2019-08-31 0001029142 us-gaap:IPOMember 2019-08-31 0001029142 dvax:SeriesBConvertiblePreferredStockMember us-gaap:IPOMember 2019-08-31 0001029142 us-gaap:IPOMember 2019-08-01 2019-08-31 0001029142 dvax:BainLifeSciencesMember 2019-08-01 2019-08-31 0001029142 dvax:BainCapitalLifeSciencesFundLimitedPartnerMember 2019-08-01 2019-08-31 0001029142 dvax:BainCapitalLifeSciencesFundLimitedPartnerMember dvax:SeriesBConvertiblePreferredStockMember 2019-08-01 2019-08-31 0001029142 dvax:BainCapitalLifeSciencesFundLimitedPartnerMember 2019-08-31 0001029142 dvax:BCIPLifeSciencesAssociatesLimitedPartnersMember 2019-08-01 2019-08-31 0001029142 dvax:BCIPLifeSciencesAssociatesLimitedPartnersMember dvax:SeriesBConvertiblePreferredStockMember 2019-08-01 2019-08-31 0001029142 dvax:BCIPLifeSciencesAssociatesLimitedPartnersMember 2019-08-31 0001029142 us-gaap:CommonStockMember dvax:BainLifeSciencesMember 2021-06-30 0001029142 us-gaap:CommonStockMember dvax:BainCapitalLifeSciencesFundLimitedPartnerMember 2021-06-30 0001029142 us-gaap:CommonStockMember dvax:BCIPLifeSciencesAssociatesLimitedPartnersMember 2021-06-30 0001029142 us-gaap:IPOMember 2020-05-31 0001029142 us-gaap:IPOMember srt:MaximumMember 2020-05-01 2020-05-31 0001029142 us-gaap:IPOMember dvax:BainCapitalLifeSciencesFundLimitedPartnerMember 2020-05-01 2020-05-31 0001029142 us-gaap:IPOMember 2020-05-01 2020-05-31 0001029142 srt:MaximumMember dvax:TwentySeventeenAtTheMarketAgreementMember 2017-11-03 2017-11-03 0001029142 srt:MaximumMember dvax:TwentySeventeenAtTheMarketAgreementMember 2017-11-03 0001029142 dvax:TwentySeventeenAtTheMarketAgreementMember 2021-01-01 2021-06-30 0001029142 srt:MaximumMember 2020-08-06 2020-08-06 0001029142 us-gaap:CommonStockMember dvax:SeriesBConvertiblePreferredStockMember 2021-06-30 0001029142 srt:MinimumMember dvax:SeriesBConvertiblePreferredStockMember 2021-01-01 2021-06-30 0001029142 srt:MaximumMember dvax:SeriesBConvertiblePreferredStockMember 2021-01-01 2021-06-30 0001029142 dvax:SeriesBConvertiblePreferredStockMember 2021-01-01 2021-06-30 0001029142 us-gaap:WarrantMember 2021-06-30 0001029142 us-gaap:WarrantMember srt:MinimumMember 2021-01-01 2021-06-30 0001029142 us-gaap:WarrantMember srt:MaximumMember 2021-01-01 2021-06-30 0001029142 us-gaap:WarrantMember 2019-08-12 0001029142 us-gaap:OtherNonoperatingIncomeExpenseMember us-gaap:WarrantMember 2021-01-01 2021-06-30 0001029142 us-gaap:OtherNonoperatingIncomeExpenseMember us-gaap:WarrantMember 2021-04-01 2021-06-30 0001029142 dvax:TwoThousandAndEighteenEquityIncentivePlanMember 2021-01-31 0001029142 dvax:TwoThousandAndEighteenEquityIncentivePlanMember 2021-06-30 0001029142 dvax:TwoThousandAndFourteenEmployeeStockPurchasePlanMember srt:MaximumMember 2021-05-31 0001029142 dvax:TwoThousandAndFourteenEmployeeStockPurchasePlanMember 2021-06-30 0001029142 srt:MinimumMember us-gaap:EmployeeStockOptionMember 2021-01-01 2021-06-30 0001029142 us-gaap:EmployeeStockOptionMember srt:MaximumMember 2021-01-01 2021-06-30 0001029142 dvax:UnvestedMember 2021-01-01 2021-06-30 0001029142 dvax:VestedMember 2021-01-01 2021-06-30 0001029142 us-gaap:RestrictedStockUnitsRSUMember 2020-12-31 0001029142 us-gaap:RestrictedStockUnitsRSUMember 2021-01-01 2021-06-30 0001029142 us-gaap:RestrictedStockUnitsRSUMember 2021-06-30 0001029142 dvax:PerformanceBasedRestrictedStockUnitsMember 2021-01-01 2021-06-30 0001029142 dvax:PerformanceBasedRestrictedStockUnitsMember 2021-06-30 0001029142 us-gaap:EmployeeStockOptionMember 2021-04-01 2021-06-30 0001029142 us-gaap:EmployeeStockOptionMember 2020-04-01 2020-06-30 0001029142 us-gaap:EmployeeStockOptionMember 2021-01-01 2021-06-30 0001029142 us-gaap:EmployeeStockOptionMember 2020-01-01 2020-06-30 0001029142 dvax:MarketBasedPerformanceStockUnitMember 2021-01-01 2021-06-30 0001029142 us-gaap:EmployeeStockOptionMember srt:MinimumMember 2021-04-01 2021-06-30 0001029142 us-gaap:EmployeeStockOptionMember srt:MinimumMember 2020-04-01 2020-06-30 0001029142 us-gaap:EmployeeStockOptionMember srt:MinimumMember 2020-01-01 2020-06-30 0001029142 dvax:MarketBasedPerformanceStockUnitMember srt:MinimumMember 2021-01-01 2021-06-30 0001029142 dvax:MarketBasedPerformanceStockUnitMember srt:MaximumMember 2021-01-01 2021-06-30 0001029142 us-gaap:ResearchAndDevelopmentExpenseMember 2021-04-01 2021-06-30 0001029142 us-gaap:ResearchAndDevelopmentExpenseMember 2020-04-01 2020-06-30 0001029142 us-gaap:ResearchAndDevelopmentExpenseMember 2021-01-01 2021-06-30 0001029142 us-gaap:ResearchAndDevelopmentExpenseMember 2020-01-01 2020-06-30 0001029142 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2021-04-01 2021-06-30 0001029142 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2020-04-01 2020-06-30 0001029142 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2021-01-01 2021-06-30 0001029142 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2020-01-01 2020-06-30 0001029142 us-gaap:CostOfSalesMember 2021-04-01 2021-06-30 0001029142 us-gaap:CostOfSalesMember 2020-04-01 2020-06-30 0001029142 us-gaap:CostOfSalesMember 2021-01-01 2021-06-30 0001029142 us-gaap:CostOfSalesMember 2020-01-01 2020-06-30 0001029142 us-gaap:InventoriesMember 2021-04-01 2021-06-30 0001029142 us-gaap:InventoriesMember 2020-04-01 2020-06-30 0001029142 us-gaap:InventoriesMember 2021-01-01 2021-06-30 0001029142 us-gaap:InventoriesMember 2020-01-01 2020-06-30

 

 

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 June 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 July 30, 2021, the registrant had outstanding 114,760,092 shares of common stock.

 

 

 


 

INDEX

DYNAVAX TECHNOLOGIES CORPORATION

 

 

Page No.

PART I FINANCIAL INFORMATION

 

 

Item 1.

Financial Statements (unaudited)

6

 

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

6

 

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2021 and 2020

7

 

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

7

 

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

8

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020

9

 

Notes to Condensed Consolidated Financial Statements

10

Item 2.

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

29

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

37

Item 4.

Controls and Procedures

37

 

PART II OTHER INFORMATION

 

 

Item 1.

Legal Proceedings

38

Item 1A.

Risk Factors

38

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

60

Item 5.

Other Information

60

Item 6.

Exhibits

61

 

SIGNATURES

63

 

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 CpG 1018, 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 are inadequate; we may be unable to realize any commercial benefit from the development of a vaccine containing CpG 1018.

 

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 product 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.

 

We have incurred net losses in each year since our inception and anticipate that we will continue to incur significant losses for the foreseeable future unless we can successfully commercialize HEPLISAV-B or continue to sell significant quantities of CpG 1018, and if we are unable to achieve and 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, we will 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.

 

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

4


 

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 CpG 1018, 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, 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 product candidates in commercial quantities. With respect to HEPLISAV-B, we have switched to a pre-filled syringe presentation of the vaccine and our ability to meet future demand will depend on our ability to manufacture 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.

 

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.

 

5


 

PART I. FINANCIAL INFORMATION

 

ITEM 1.

FINANCIAL STATEMENTS

Dynavax Technologies Corporation

Condensed Consolidated Balance Sheets

(In thousands, except per share amounts)

 

 

June 30,

 

 

December 31,

 

 

2021

 

 

2020

 

 

(unaudited)

 

 

(Note 1)

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

129,608

 

 

$

32,073

 

Marketable securities available-for-sale

 

216,196

 

 

 

132,963

 

Accounts and other receivables, net

 

105,900

 

 

 

22,661

 

Inventories, net

 

86,451

 

 

 

63,689

 

Prepaid manufacturing

 

36,298

 

 

 

29,423

 

Prepaid expenses and other current assets

 

9,453

 

 

 

9,206

 

Total current assets

 

583,906

 

 

 

290,015

 

Property and equipment, net

 

32,547

 

 

 

30,567

 

Operating lease right-of-use assets

 

25,164

 

 

 

26,583

 

Goodwill

 

2,225

 

 

 

2,297

 

Restricted cash

 

229

 

 

 

237

 

Other assets

 

3,838

 

 

 

3,573

 

Total assets

$

647,909

 

 

$

353,272

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

12,079

 

 

$

3,312

 

Accrued research and development

 

4,167

 

 

 

2,805

 

Accrued liabilities

 

25,711

 

 

 

19,099

 

Warrant liability

 

29,639

 

 

 

10,736

 

Deferred revenue

 

129,557

 

 

 

38,212

 

Other current liabilities

 

3,489

 

 

 

3,247

 

Total current liabilities

 

204,642

 

 

 

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 $5,541 at June 30, 2021 (see Note 7)

 

219,959

 

 

 

-

 

Long-term deferred revenue

 

106,950

 

 

 

-

 

Long-term portion of lease liabilities

 

32,897

 

 

 

34,789

 

Other long-term liabilities

 

81

 

 

 

2,568

 

Total liabilities

 

564,529

 

 

 

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  ̶  4 shares at June 30, 2021

   and December 31, 2020

 

-

 

 

 

-

 

Common stock: $0.001 par value; 278,000 shares authorized at

   June 30, 2021 and December 31, 2020; 114,756 shares and 110,190

   shares issued and outstanding at June 30, 2021 and December 31, 2020,

   respectively

 

114

 

 

 

110

 

Additional paid-in capital

 

1,372,679

 

 

 

1,352,374

 

Accumulated other comprehensive (loss) gain

 

(713

)

 

 

273

 

Accumulated deficit

 

(1,288,700

)

 

 

(1,294,064

)

Total stockholders’ equity

 

83,380

 

 

 

58,693

 

Total liabilities and stockholders’ equity

$

647,909

 

 

$

353,272

 

 

See accompanying notes.

6


Dynavax Technologies Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

52,677

 

 

$

2,405

 

 

$

135,562

 

 

$

12,919

 

Other revenue

 

 

90

 

 

 

263

 

 

 

540

 

 

 

668

 

Total revenues

 

 

52,767

 

 

 

2,668

 

 

 

136,102

 

 

 

13,587

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales - product

 

 

14,845

 

 

 

967

 

 

 

39,470

 

 

 

3,321

 

Cost of sales - amortization of intangible assets

 

 

-

 

 

 

202

 

 

 

-

 

 

 

2,500

 

Research and development

 

 

7,167

 

 

 

5,884

 

 

 

14,925

 

 

 

10,537

 

Selling, general and administrative

 

 

21,583

 

 

 

18,954

 

 

 

44,006

 

 

 

39,880

 

Total operating expenses

 

 

43,595

 

 

 

26,007

 

 

 

98,401

 

 

 

56,238

 

Income (loss) from operations

 

 

9,172

 

 

 

(23,339

)

 

 

37,701

 

 

 

(42,651

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

48

 

 

 

331

 

 

 

95

 

 

 

921

 

Interest expense

 

 

(3,109

)

 

 

(4,732

)

 

 

(7,821

)

 

 

(9,463

)

Sublease income

 

 

1,670

 

 

 

1,927

 

 

 

3,692

 

 

 

3,853

 

Loss on debt extinguishment (Note 8)

 

 

(5,232

)

 

 

-

 

 

 

(5,232

)

 

 

-

 

Change in fair value of warrant liability (Note 11)

 

 

2,097

 

 

 

(25,655

)

 

 

(23,455

)

 

 

(17,045

)

Other

 

 

(173

)

 

 

(111

)

 

 

384

 

 

 

211

 

Net income (loss)

 

 

4,473

 

 

 

(51,579

)

 

 

5,364

 

 

 

(64,174

)

Net income (loss) per share attributable to common stockholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.04

 

 

$

(0.53

)

 

$

0.04

 

 

$

(0.70

)

Diluted

 

$

0.02

 

 

$

(0.53

)

 

$

0.04

 

 

$

(0.70

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

114,629

 

 

 

97,339

 

 

 

113,339

 

 

 

91,408

 

Diluted

 

 

118,830

 

 

 

97,339

 

 

 

114,978

 

 

 

91,408

 

 

Condensed Consolidated Statements of Comprehensive Loss

(In thousands)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net income (loss)

 

$

4,473

 

 

$

(51,579

)

 

$

5,364

 

 

$

(64,174

)

Other comprehensive income (loss), net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

   for-sale

 

 

38

 

 

 

(99

)

 

 

29

 

 

 

192

 

Foreign currency translation adjustments

 

 

375

 

 

 

579

 

 

 

(1,015

)

 

 

100

 

Total other comprehensive income (loss)

 

 

413

 

 

 

480

 

 

 

(986

)

 

 

292

 

Total comprehensive income (loss)

 

$

4,886

 

 

$

(51,099

)

 

$

4,378

 

 

$

(63,882

)

 

See accompanying notes.

 

 

7


 

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 June 30, 2021

 

Shares

 

 

Par Amount

 

 

Shares

 

 

Par Amount

 

 

Capital

 

 

(Loss) Income

 

 

Deficit

 

 

Equity

 

Balances at March 31, 2021

 

 

114,563

 

 

$

114

 

 

 

4

 

 

$

-

 

 

$

1,393,947

 

 

$

(1,126

)

 

$

(1,293,173

)

 

$

99,762

 

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

 

 

193

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

948

 

 

 

-

 

 

 

-

 

 

 

948

 

Purchase of capped call options related to issuance of Convertible Notes (see Note 7)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(27,240

)

 

 

-

 

 

 

-

 

 

 

(27,240

)

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,024

 

 

 

-

 

 

 

-

 

 

 

5,024

 

Total other comprehensive income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

413

 

 

 

-

 

 

 

413

 

Net income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,473

 

 

 

4,473

 

Balances at June 30, 2021

 

 

114,756

 

 

$

114

 

 

 

4

 

 

$

-

 

 

$

1,372,679

 

 

$

(713

)

 

$

(1,288,700

)

 

$

83,380

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at December 31, 2020

 

 

110,190

 

 

$

110

 

 

 

4

 

 

$

-

 

 

$

1,352,374

 

 

$

273

 

 

$

(1,294,064

)

 

$

58,693

 

Exercise of warrants

 

 

750

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

7,927

 

 

 

-

 

 

 

-

 

 

 

7,928

 

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

 

 

833

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,335

 

 

 

-

 

 

 

-

 

 

 

1,335

 

Issuance of common stock under Employee Stock Purchase Plan

 

 

104

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

383

 

 

 

-

 

 

 

-

 

 

 

383

 

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

 

Purchase of capped call options related to issuance of Convertible Notes (see Note 7)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(27,240

)

 

 

-

 

 

 

-

 

 

 

(27,240

)

Stock compensation expense

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

9,747

 

 

 

-

 

 

 

-

 

 

 

9,747

 

Total other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(986

)

 

 

-

 

 

 

(986

)

Net income

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,364

 

 

 

5,364

 

Balances at June 30, 2021

 

 

114,756

 

 

$

114

 

 

 

4

 

 

$

-

 

 

$

1,372,679

 

 

$

(713

)

 

$

(1,288,700

)

 

$

83,380

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Preferred Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

Three Months June 30, 2020

 

Shares

 

 

Par Amount

 

 

Shares

 

 

Par Amount