dvax-10q_20190930.htm
false Q3 0001029142 --12-31 Large Accelerated Filer false false P1Y P5Y P4Y P3Y P4Y6M25D P4Y6M3D P3Y6M25D P4Y6M P4Y6M P4Y6M P4Y6M P1Y3M18D P1Y3M18D 0001029142 2019-01-01 2019-09-30 xbrli:shares 0001029142 2019-11-01 iso4217:USD 0001029142 2019-09-30 0001029142 2018-12-31 0001029142 dvax:SeriesBConvertiblePreferredStockMember 2019-09-30 0001029142 dvax:SeriesBConvertiblePreferredStockMember 2018-12-31 iso4217:USD xbrli:shares 0001029142 us-gaap:ProductMember 2019-07-01 2019-09-30 0001029142 us-gaap:ProductMember 2018-07-01 2018-09-30 0001029142 us-gaap:ProductMember 2019-01-01 2019-09-30 0001029142 us-gaap:ProductMember 2018-01-01 2018-09-30 0001029142 dvax:OtherRevenueMember 2019-07-01 2019-09-30 0001029142 dvax:OtherRevenueMember 2019-01-01 2019-09-30 0001029142 2019-07-01 2019-09-30 0001029142 2018-07-01 2018-09-30 0001029142 2018-01-01 2018-09-30 0001029142 us-gaap:CommonStockMember 2019-06-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2019-06-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-06-30 0001029142 us-gaap:RetainedEarningsMember 2019-06-30 0001029142 2019-06-30 0001029142 us-gaap:CommonStockMember 2019-07-01 2019-09-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2019-07-01 2019-09-30 0001029142 us-gaap:PreferredStockMember dvax:SeriesBConvertiblePreferredStockMember 2019-07-01 2019-09-30 0001029142 us-gaap:AdditionalPaidInCapitalMember dvax:SeriesBConvertiblePreferredStockMember 2019-07-01 2019-09-30 0001029142 dvax:SeriesBConvertiblePreferredStockMember 2019-07-01 2019-09-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-07-01 2019-09-30 0001029142 us-gaap:RetainedEarningsMember 2019-07-01 2019-09-30 0001029142 us-gaap:CommonStockMember 2019-09-30 0001029142 us-gaap:PreferredStockMember 2019-09-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2019-09-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-09-30 0001029142 us-gaap:RetainedEarningsMember 2019-09-30 0001029142 us-gaap:CommonStockMember 2018-12-31 0001029142 us-gaap:AdditionalPaidInCapitalMember 2018-12-31 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-12-31 0001029142 us-gaap:RetainedEarningsMember 2018-12-31 0001029142 us-gaap:CommonStockMember 2019-01-01 2019-09-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2019-01-01 2019-09-30 0001029142 us-gaap:PreferredStockMember dvax:SeriesBConvertiblePreferredStockMember 2019-01-01 2019-09-30 0001029142 us-gaap:AdditionalPaidInCapitalMember dvax:SeriesBConvertiblePreferredStockMember 2019-01-01 2019-09-30 0001029142 dvax:SeriesBConvertiblePreferredStockMember 2019-01-01 2019-09-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-01-01 2019-09-30 0001029142 us-gaap:RetainedEarningsMember 2019-01-01 2019-09-30 0001029142 us-gaap:CommonStockMember 2018-06-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2018-06-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-06-30 0001029142 us-gaap:RetainedEarningsMember 2018-06-30 0001029142 2018-06-30 0001029142 us-gaap:CommonStockMember 2018-07-01 2018-09-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2018-07-01 2018-09-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-07-01 2018-09-30 0001029142 us-gaap:RetainedEarningsMember 2018-07-01 2018-09-30 0001029142 us-gaap:CommonStockMember 2018-09-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2018-09-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-09-30 0001029142 us-gaap:RetainedEarningsMember 2018-09-30 0001029142 2018-09-30 0001029142 us-gaap:CommonStockMember 2017-12-31 0001029142 us-gaap:AdditionalPaidInCapitalMember 2017-12-31 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2017-12-31 0001029142 us-gaap:RetainedEarningsMember 2017-12-31 0001029142 2017-12-31 0001029142 us-gaap:CommonStockMember 2018-01-01 2018-09-30 0001029142 us-gaap:AdditionalPaidInCapitalMember 2018-01-01 2018-09-30 0001029142 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-01-01 2018-09-30 0001029142 us-gaap:RetainedEarningsMember 2018-01-01 2018-09-30 0001029142 dvax:HEPLISAVBMember 2019-01-01 2019-09-30 dvax:Position 0001029142 2019-05-22 2019-05-23 xbrli:pure dvax:Segment 0001029142 2019-08-01 2019-08-31 0001029142 srt:MaximumMember 2019-01-01 2019-09-30 0001029142 us-gaap:AccountingStandardsUpdate201602Member 2019-01-01 0001029142 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:WarrantMember us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:WarrantMember us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 dvax:SublicenseLiabilityMember us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 dvax:SublicenseLiabilityMember us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2019-09-30 0001029142 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:USGovernmentAgenciesDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:CorporateDebtSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:FairValueInputsLevel2Member us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 dvax:SublicenseLiabilityMember us-gaap:FairValueInputsLevel3Member us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 dvax:SublicenseLiabilityMember us-gaap:FairValueMeasurementsRecurringMember 2018-12-31 0001029142 us-gaap:FairValueInputsLevel3Member 2019-09-30 0001029142 us-gaap:FairValueInputsLevel3Member 2019-01-01 2019-09-30 0001029142 dvax:MerckSharpAndDohmeCorporationMember 2019-09-30 0001029142 dvax:MerckSharpAndDohmeCorporationMember us-gaap:FairValueInputsLevel3Member 2019-09-30 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:CashMember 2019-09-30 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:MoneyMarketFundsMember 2019-09-30 0001029142 us-gaap:CashAndCashEquivalentsMember 2019-09-30 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:USTreasurySecuritiesMember 2019-09-30 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2019-09-30 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:CorporateDebtSecuritiesMember 2019-09-30 0001029142 us-gaap:AvailableforsaleSecuritiesMember 2019-09-30 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:CashMember 2018-12-31 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:MoneyMarketFundsMember 2018-12-31 0001029142 us-gaap:CashAndCashEquivalentsMember us-gaap:CorporateDebtSecuritiesMember 2018-12-31 0001029142 us-gaap:CashAndCashEquivalentsMember 2018-12-31 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:USTreasurySecuritiesMember 2018-12-31 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2018-12-31 0001029142 us-gaap:AvailableforsaleSecuritiesMember us-gaap:CorporateDebtSecuritiesMember 2018-12-31 0001029142 us-gaap:AvailableforsaleSecuritiesMember 2018-12-31 utr:sqft 0001029142 stpr:CA dvax:PowellStreetSubleaseMember 2019-07-31 0001029142 stpr:CA dvax:PowellStreetSubleaseMember 2019-07-31 2019-07-31 0001029142 stpr:CA dvax:PowellStreetSubleaseMember 2019-01-01 2019-09-30 0001029142 stpr:CA dvax:HortonStreetMasterLeaseMember 2018-09-17 0001029142 stpr:CA dvax:HortonStreetMasterLeaseMember 2018-09-16 2018-09-17 0001029142 stpr:CA srt:MaximumMember 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 2019-07-01 2019-09-30 0001029142 dvax:HortonStreetSubleaseMember stpr:CA 2019-01-01 2019-09-30 0001029142 dvax:HortonStreetMasterLeaseMember 2019-09-30 0001029142 2018-02-28 0001029142 2018-02-01 2018-02-28 0001029142 dvax:SublicenseAgreementMember dvax:MerckSharpAndDohmeCorporationMember 2018-02-01 2018-02-28 0001029142 srt:ScenarioForecastMember dvax:SublicenseAgreementMember dvax:MerckSharpAndDohmeCorporationMember 2020-01-01 2020-03-31 0001029142 dvax:SymphonyDynamoHoldingsLlcMember 2009-11-30 0001029142 dvax:SymphonyDynamoHoldingsLlcMember 2009-11-01 2009-11-30 0001029142 dvax:SymphonyDynamoHoldingsLlcMember 2019-01-01 2019-09-30 0001029142 dvax:CollaborationRevenueMember dvax:SerumInstituteOfIndiaPrivateLimitedMember 2019-01-01 2019-09-30 0001029142 dvax:CollaborationRevenueMember dvax:SerumInstituteOfIndiaPrivateLimitedMember 2018-01-01 2018-09-30 dvax:Installment 0001029142 dvax:SublicenseAgreementMember dvax:MerckSharpAndDohmeCorporationMember 2019-02-01 2019-02-28 0001029142 dvax:SublicenseAgreementMember dvax:MerckSharpAndDohmeCorporationMember 2019-09-30 0001029142 dvax:SublicenseAgreementMember dvax:MerckSharpAndDohmeCorporationMember 2018-12-31 0001029142 dvax:CRGServicingLLCMember 2018-02-20 0001029142 dvax:CRGServicingLLCMember 2019-03-29 0001029142 dvax:CRGServicingLLCMember dvax:InitialTermLoanMember 2018-02-19 2018-02-20 0001029142 dvax:CRGServicingLLCMember dvax:SecondTrancheMember 2018-02-19 2018-02-20 0001029142 dvax:CRGServicingLLCMember 2019-09-30 0001029142 dvax:CRGServicingLLCMember 2018-02-19 2018-02-20 0001029142 dvax:LoanAgreementMember 2019-07-31 0001029142 dvax:LoanAgreementMember 2019-08-01 0001029142 dvax:LoanAgreementMember 2018-02-19 2018-02-20 0001029142 dvax:LoanAgreementMember 2018-02-20 0001029142 srt:MaximumMember dvax:LoanAgreementMember 2018-02-19 2018-02-20 0001029142 dvax:LoanAgreementMember 2019-07-01 2019-09-30 0001029142 dvax:LoanAgreementMember 2018-07-01 2018-09-30 0001029142 dvax:LoanAgreementMember 2019-01-01 2019-09-30 0001029142 dvax:LoanAgreementMember 2018-01-01 2018-09-30 0001029142 us-gaap:RevenueFromContractWithCustomerMember us-gaap:ProductMember us-gaap:CreditConcentrationRiskMember 2019-01-01 2019-09-30 0001029142 dvax:ChargebacksDistributionFeesDiscountsAndOtherFeesMember dvax:HEPLISAVBMember 2018-12-31 0001029142 dvax:AllowancesForSalesReturnsMember dvax:HEPLISAVBMember 2018-12-31 0001029142 dvax:HEPLISAVBMember 2018-12-31 0001029142 dvax:ChargebacksDistributionFeesDiscountsAndOtherFeesMember dvax:HEPLISAVBMember 2019-01-01 2019-09-30 0001029142 dvax:AllowancesForSalesReturnsMember dvax:HEPLISAVBMember 2019-01-01 2019-09-30 0001029142 dvax:ChargebacksDistributionFeesDiscountsAndOtherFeesMember dvax:HEPLISAVBMember 2019-09-30 0001029142 dvax:AllowancesForSalesReturnsMember dvax:HEPLISAVBMember 2019-09-30 0001029142 dvax:HEPLISAVBMember 2019-09-30 0001029142 dvax:ChargebacksDiscountsAndOtherFeesMember 2019-09-30 0001029142 dvax:StockOptionsAndShareAwardsMember 2019-01-01 2019-09-30 0001029142 dvax:StockOptionsAndShareAwardsMember 2019-07-01 2019-09-30 0001029142 dvax:StockOptionsAndShareAwardsMember 2018-01-01 2018-09-30 0001029142 dvax:StockOptionsAndShareAwardsMember 2018-07-01 2018-09-30 0001029142 us-gaap:ConvertiblePreferredStockMember 2019-01-01 2019-09-30 0001029142 us-gaap:ConvertiblePreferredStockMember 2019-07-01 2019-09-30 0001029142 us-gaap:WarrantMember 2019-01-01 2019-09-30 0001029142 us-gaap:WarrantMember 2019-07-01 2019-09-30 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 srt:MaximumMember dvax:TwentySeventeenAtTheMarketAgreementMember 2017-11-03 2017-11-03 0001029142 srt:MaximumMember dvax:TwentySeventeenAtTheMarketAgreementMember 2017-11-03 0001029142 dvax:TwentySeventeenAtTheMarketAgreementMember 2019-01-01 2019-09-30 0001029142 dvax:SeriesBConvertiblePreferredStockMember us-gaap:CommonStockMember 2019-09-30 0001029142 dvax:SeriesBConvertiblePreferredStockMember srt:MinimumMember 2019-01-01 2019-09-30 0001029142 dvax:SeriesBConvertiblePreferredStockMember srt:MaximumMember 2019-01-01 2019-09-30 0001029142 us-gaap:WarrantMember 2019-01-01 2019-09-30 0001029142 us-gaap:WarrantMember 2019-09-30 0001029142 us-gaap:WarrantMember srt:MinimumMember 2019-01-01 2019-09-30 0001029142 us-gaap:WarrantMember srt:MaximumMember 2019-01-01 2019-09-30 0001029142 us-gaap:WarrantMember 2019-08-12 0001029142 us-gaap:OtherNonoperatingIncomeExpenseMember us-gaap:WarrantMember 2019-01-01 2019-09-30 0001029142 us-gaap:OtherNonoperatingIncomeExpenseMember us-gaap:WarrantMember 2019-07-01 2019-09-30 0001029142 dvax:TwoThousandAndEighteenEquityIncentivePlanMember 2018-05-31 0001029142 dvax:TwoThousandAndElevenEquityIncentivePlanMember 2018-05-31 0001029142 dvax:AmendedTwoThousandAndEighteenEquityIncentivePlanMember 2019-05-29 2019-05-30 0001029142 dvax:AmendedTwoThousandAndEighteenEquityIncentivePlanMember 2019-05-30 0001029142 dvax:TwoThousandAndEighteenEquityIncentivePlanMember 2019-09-30 0001029142 dvax:UnvestedMember 2019-01-01 2019-09-30 0001029142 dvax:VestedMember 2019-01-01 2019-09-30 0001029142 us-gaap:RestrictedStockUnitsRSUMember 2018-12-31 0001029142 us-gaap:RestrictedStockUnitsRSUMember 2019-01-01 2019-09-30 0001029142 us-gaap:RestrictedStockUnitsRSUMember 2019-09-30 0001029142 us-gaap:EmployeeStockOptionMember 2019-09-30 0001029142 us-gaap:PerformanceSharesMember 2019-09-30 0001029142 srt:MinimumMember us-gaap:EmployeeStockOptionMember 2019-01-01 2019-09-30 0001029142 us-gaap:EmployeeStockOptionMember srt:MaximumMember 2019-01-01 2019-09-30 0001029142 us-gaap:EmployeeStockOptionMember 2019-07-01 2019-09-30 0001029142 us-gaap:EmployeeStockOptionMember 2018-07-01 2018-09-30 0001029142 us-gaap:EmployeeStockOptionMember 2019-01-01 2019-09-30 0001029142 us-gaap:EmployeeStockOptionMember 2018-01-01 2018-09-30 0001029142 us-gaap:EmployeeStockMember 2019-01-01 2019-09-30 0001029142 us-gaap:EmployeeStockMember 2018-01-01 2018-09-30 0001029142 us-gaap:ResearchAndDevelopmentExpenseMember 2019-07-01 2019-09-30 0001029142 us-gaap:ResearchAndDevelopmentExpenseMember 2018-07-01 2018-09-30 0001029142 us-gaap:ResearchAndDevelopmentExpenseMember 2019-01-01 2019-09-30 0001029142 us-gaap:ResearchAndDevelopmentExpenseMember 2018-01-01 2018-09-30 0001029142 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2019-07-01 2019-09-30 0001029142 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2018-07-01 2018-09-30 0001029142 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2019-01-01 2019-09-30 0001029142 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2018-01-01 2018-09-30 0001029142 us-gaap:RestructuringChargesMember 2019-01-01 2019-09-30 0001029142 us-gaap:CostOfSalesMember 2019-07-01 2019-09-30 0001029142 us-gaap:CostOfSalesMember 2018-07-01 2018-09-30 0001029142 us-gaap:CostOfSalesMember 2019-01-01 2019-09-30 0001029142 us-gaap:CostOfSalesMember 2018-01-01 2018-09-30 0001029142 us-gaap:InventoriesMember 2019-07-01 2019-09-30 0001029142 us-gaap:InventoriesMember 2018-07-01 2018-09-30 0001029142 us-gaap:InventoriesMember 2019-01-01 2019-09-30 0001029142 us-gaap:InventoriesMember 2018-01-01 2018-09-30 0001029142 dvax:TimeBasedVestingScheduleMember 2019-09-30 0001029142 dvax:PerformanceBasedVestingScheduleMember 2019-09-30 0001029142 dvax:TimeBasedVestingScheduleMember 2019-01-01 2019-09-30 0001029142 2018-05-01 2018-05-31 0001029142 us-gaap:ShareBasedCompensationAwardTrancheOneMember dvax:TwoThousandAndFourteenEmployeeStockPurchasePlanMember 2014-05-27 2014-05-28 0001029142 us-gaap:ShareBasedCompensationAwardTrancheTwoMember dvax:TwoThousandAndFourteenEmployeeStockPurchasePlanMember 2014-05-27 2014-05-28 0001029142 dvax:TwoThousandAndFourteenEmployeeStockPurchasePlanMember 2019-01-01 2019-09-30 0001029142 dvax:TwoThousandAndFourteenEmployeeStockPurchasePlanMember 2019-09-30 0001029142 dvax:SeveranceAndOtherTerminationBenefitsMember 2019-09-30 0001029142 dvax:StockBasedCompensationExpenseMember 2019-09-30 0001029142 dvax:AcceleratedDepreciationMember 2019-09-30 0001029142 dvax:EmployeeSeveranceAndOtherBenefitsMember 2019-01-01 2019-09-30 0001029142 dvax:EmployeeSeveranceAndOtherBenefitsMember 2019-09-30

 

 

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 September 30, 2019

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, 2019, the registrant had outstanding 83,865,119 shares of common stock.

 

 

 


INDEX

DYNAVAX TECHNOLOGIES CORPORATION

 

 

Page No.

PART I FINANCIAL INFORMATION

 

 

Item 1.

Financial Statements (unaudited)

4

 

Condensed Consolidated Balance Sheets as of September 30, 2019 and December 31, 2018

4

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2019 and 2018

5

 

Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2019 and 2018

5

 

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2019 and 2018

6

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2019 and 2018

7

 

Notes to Condensed Consolidated Financial Statements

8

Item 2.

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

24

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

30

Item 4.

Controls and Procedures

30

 

PART II OTHER INFORMATION

 

 

Item 1.

Legal Proceedings

31

Item 1A.

Risk Factors

31

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

46

Item 5.

Other Information

46

Item 6.

Exhibits

47

 

SIGNATURES

49

 

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 our ability to successfully commercialize HEPLISAV-B®, our anticipated market opportunity and level of sales of HEPLISAV-B, our ability to successfully pursue strategic alternatives for our early stage compounds, our business, collaboration and regulatory strategy, and whether or not we may incur other material charges not currently contemplated due to events that may occur as a result of, or associated with our restructuring, our ability to manufacture commercial supply and 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, where appropriate, its subsidiary Dynavax GmbH.

 

 

 

3


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,

 

 

2019

 

 

2018

 

 

(unaudited)

 

 

(Note 1)

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

37,297

 

 

$

49,348

 

Marketable securities available-for-sale

 

137,649

 

 

 

96,188

 

Accounts and other receivables, net

 

8,822

 

 

 

3,704

 

Inventories, net

 

39,356

 

 

 

19,022

 

Prepaid expenses and other current assets

 

5,711

 

 

 

6,102

 

Total current assets

 

228,835

 

 

 

174,364

 

Property and equipment, net

 

31,461

 

 

 

17,064

 

Intangible assets, net

 

4,823

 

 

 

11,717

 

Operating lease right-of-use assets

 

29,723

 

 

 

-

 

Goodwill

 

2,045

 

 

 

2,144

 

Restricted cash

 

619

 

 

 

619

 

Other assets

 

3,509

 

 

 

4,976

 

Total assets

$

301,015

 

 

$

210,884

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

7,660

 

 

$

5,278

 

Accrued research and development

 

4,242

 

 

 

9,714

 

Accrued liabilities

 

17,003

 

 

 

16,041

 

Warrant liability

 

7,594

 

 

 

-

 

Other current liabilities

 

9,849

 

 

 

7,000

 

Total current liabilities

 

46,348

 

 

 

38,033

 

Long-term debt, net

 

177,615

 

 

 

100,871

 

Long-term portion of lease liabilities

 

36,964

 

 

 

-

 

Other long-term liabilities

 

932

 

 

 

8,915

 

Total liabilities

 

261,859

 

 

 

147,819

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

Preferred stock: $0.001 par value

 

 

 

 

 

 

 

Authorized: 5,000 shares; Issued and outstanding:

 

-

 

 

 

-

 

Series B Convertible Preferred stock  ̶  5 shares at September 30, 2019 and no shares at December 31, 2018

 

-

 

 

 

-

 

Common stock: $0.001 par value; 139,000 shares authorized at

  September 30, 2019 and December 31, 2018; 83,865 and 62,862 shares

  issued and outstanding at September 30, 2019 and December 31, 2018, respectively

 

84

 

 

 

63

 

Additional paid-in capital

 

1,224,228

 

 

 

1,131,241

 

Accumulated other comprehensive loss

 

(3,088

)

 

 

(2,015

)

Accumulated deficit

 

(1,182,068

)

 

 

(1,066,224

)

Total stockholders’ equity

 

39,156

 

 

 

63,065

 

Total liabilities and stockholders’ equity

$

301,015

 

 

$

210,884

 

 

See accompanying notes.

4


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,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

$

10,158

 

 

$

1,461

 

 

$

24,086

 

 

$

2,880

 

Other revenue

 

417

 

 

 

-

 

 

 

563

 

 

 

-

 

Total revenues

 

10,575

 

 

 

1,461

 

 

 

24,649

 

 

 

2,880

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales - product

 

3,824

 

 

 

3,927

 

 

 

7,765

 

 

 

9,309

 

Cost of sales - amortization of intangible assets

 

2,324

 

 

 

3,823

 

 

 

6,894

 

 

 

8,538

 

Research and development

 

12,660

 

 

 

16,820

 

 

 

50,062

 

 

 

52,059

 

Selling, general and administrative

 

18,459

 

 

 

15,788

 

 

 

54,668

 

 

 

48,332

 

Restructuring

 

3,937

 

 

 

-

 

 

 

12,714

 

 

 

-

 

Total operating expenses

 

41,204

 

 

 

40,358

 

 

 

132,103

 

 

 

118,238

 

Loss from operations

 

(30,629

)

 

 

(38,897

)

 

 

(107,454

)

 

 

(115,358

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

890

 

 

 

1,047

 

 

 

2,604

 

 

 

2,940

 

Interest expense

 

(4,779

)

 

 

(2,735

)

 

 

(12,111

)

 

 

(6,587

)

Sublease income

 

891

 

 

 

-

 

 

 

891

 

 

 

-

 

Other income, net

 

168

 

 

 

57

 

 

 

226

 

 

 

75

 

Net loss

 

(33,459

)

 

 

(40,528

)

 

 

(115,844

)

 

 

(118,930

)

Preferred stock deemed dividend

 

(3,267

)

 

 

-

 

 

 

(3,267

)

 

 

-

 

Net loss allocable to common stockholders

$

(36,726

)

 

$

(40,528

)

 

$

(119,111

)

 

$

(118,930

)

Net loss per share allocable to common stockholders - basic and

   diluted

$

(0.49

)

 

$

(0.65

)

 

$

(1.75

)

 

$

(1.91

)

Weighted average shares used to compute basic and diluted net loss

   per share allocable to common stockholders

 

75,106

 

 

 

62,650

 

 

 

68,032

 

 

 

62,250

 

 

 

Condensed Consolidated Statements of Comprehensive Loss

(In thousands)

(Unaudited)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net loss

$

(33,459

)

 

$

(40,528

)

 

$

(115,844

)

 

$

(118,930

)

Other comprehensive income (loss), net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized (loss) gain on marketable securities available-for-sale

 

(71

)

 

 

(10

)

 

 

105

 

 

 

(15

)

Foreign currency translation adjustments

 

(1,034

)

 

 

(167

)

 

 

(1,178

)

 

 

(791

)

Total other comprehensive loss

 

(1,105

)

 

 

(177

)

 

 

(1,073

)

 

 

(806

)

Total comprehensive loss

$

(34,564

)

 

$

(40,705

)

 

$

(116,917

)

 

$

(119,736

)

 

See accompanying notes.

5


Dynavax Technologies Corporation

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands)

(Unaudited)

 

 

Common Stock

 

 

Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 2019

Shares

 

 

Par Amount

 

 

Shares

 

 

Par Amount

 

 

Additional

Paid-In Capital

 

 

Accumulated Other

Comprehensive

(Loss) Income

 

 

Accumulated

Deficit

 

 

Total

Stockholders'

Equity

 

Balances at June 30, 2019

 

65,155

 

 

$

65

 

 

 

-

 

 

$

-

 

 

$

1,161,115

 

 

$

(1,983

)

 

$

(1,148,609

)

 

 

10,588

 

Issuance of common stock upon exercise

   of stock options and restricted stock

   awards, net

 

138

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

-

 

 

 

-

 

 

 

-

 

Issuance of common stock under

   Employee Stock Purchase Plan

 

47

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

158

 

 

 

-

 

 

 

-

 

 

 

158

 

Issuance of common stock, net of issuance

   costs

 

18,525

 

 

 

19

 

 

 

-

 

 

 

-

 

 

 

46,146

 

 

 

-

 

 

 

-

 

 

 

46,165

 

Issuance of Series B convertible preferred

   stock, net of issuance costs

 

-

 

 

 

-

 

 

 

5

 

 

 

-

 

 

 

12,061

 

 

 

-

 

 

 

-

 

 

 

12,061

 

Stock compensation expense

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,748

 

 

 

-

 

 

 

-

 

 

 

4,748

 

Total other comprehensive loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,105

)

 

 

-

 

 

 

(1,105

)

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(33,459

)

 

 

(33,459

)

Balances at September 30, 2019

 

83,865

 

 

$

84

 

 

 

5

 

 

$

-

 

 

$

1,224,228

 

 

$

(3,088

)

 

$

(1,182,068

)

 

$

39,156

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at December 31, 2018

 

62,862

 

 

$

63

 

 

 

-

 

 

$

-

 

 

$

1,131,241

 

 

$

(2,015

)

 

$

(1,066,224

)

 

$

63,065

 

Issuance of common stock upon exercise

   of stock options and restricted stock

   awards, net

 

969

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

2

 

Issuance of common stock under

   Employee Stock Purchase Plan

 

122

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

565

 

 

 

-

 

 

 

-

 

 

 

565

 

Issuance of common stock, net of issuance

   costs

 

19,912

 

 

 

20

 

 

 

-

 

 

 

-

 

 

 

60,093

 

 

 

-

 

 

 

-

 

 

 

60,113

 

Issuance of Series B convertible preferred

   stock, net of issuance costs

 

-

 

 

 

-

 

 

 

5

 

 

 

-

 

 

 

12,061

 

 

 

-

 

 

 

-

 

 

 

12,061

 

Stock compensation expense

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

20,267

 

 

 

-

 

 

 

-

 

 

 

20,267

 

Total other comprehensive loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(1,073

)

 

 

-

 

 

 

(1,073

)

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(115,844

)

 

 

(115,844

)

Balances at September 30, 2019

 

83,865

 

 

$

84

 

 

 

5

 

 

$

-

 

 

$

1,224,228

 

 

$

(3,088

)

 

$

(1,182,068

)

 

$

39,156

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 2018

Shares

 

 

Par Amount

 

 

Shares

 

 

Par Amount

 

 

Additional

Paid-In Capital

 

 

Accumulated Other

Comprehensive

(Loss) Income

 

 

Accumulated

Deficit

 

 

Total

Stockholders'

Equity

 

Balances at June 30, 2018

 

62,608

 

 

$

63

 

 

 

-

 

 

$

-

 

 

$

1,118,487

 

 

$

(1,510

)

 

$

(985,727

)

 

$

131,313

 

Issuance (withholding) of common stock

   upon exercise of stock options and

   restricted stock awards, net

 

16

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

20

 

 

 

-

 

 

 

-

 

 

 

20

 

Issuance of common stock under

   Employee Stock Purchase Plan

 

67

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

339

 

 

 

-

 

 

 

-

 

 

 

339

 

Stock compensation expense

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

6,046

 

 

 

-

 

 

 

-

 

 

 

6,046

 

Total other comprehensive loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(177

)

 

 

-

 

 

 

(177

)

Net loss

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(40,528

)

 

 

(40,528

)

Balances at September 30, 2018

 

62,691

 

 

$

63

 

 

 

-

 

 

$

-

 

 

$

1,124,892

 

 

$

(1,687

)

 

$

(1,026,255

)

 

$

97,013

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances at December 31, 2017

 

61,533

 

 

$

62

 

 

 

-

 

 

$

-

 

 

$