0001564590-21-055310.txt : 20211108 0001564590-21-055310.hdr.sgml : 20211108 20211108172109 ACCESSION NUMBER: 0001564590-21-055310 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 69 CONFORMED PERIOD OF REPORT: 20210930 FILED AS OF DATE: 20211108 DATE AS OF CHANGE: 20211108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Shockwave Medical, Inc. CENTRAL INDEX KEY: 0001642545 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 270494101 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-38829 FILM NUMBER: 211388958 BUSINESS ADDRESS: STREET 1: 5403 BETSY ROSS DRIVE CITY: SANTA CLARA STATE: CA ZIP: 95054 BUSINESS PHONE: (510) 279-4262 MAIL ADDRESS: STREET 1: 5403 BETSY ROSS DRIVE CITY: SANTA CLARA STATE: CA ZIP: 95054 FORMER COMPANY: FORMER CONFORMED NAME: ShockWave Medical, Inc. DATE OF NAME CHANGE: 20150515 10-Q 1 swav-10q_20210930.htm 10-Q swav-10q_20210930.htm
false Q3 0001642545 --12-31 true true P10Y P4Y Shockwave Medical, Inc., common stock, par value $0.001 per share http://fasb.org/us-gaap/2021-01-31#ProductMember http://fasb.org/us-gaap/2021-01-31#ProductMember http://fasb.org/us-gaap/2021-01-31#ProductMember http://fasb.org/us-gaap/2021-01-31#ProductMember http://fasb.org/us-gaap/2021-01-31#ProductMember http://fasb.org/us-gaap/2021-01-31#ProductMember http://fasb.org/us-gaap/2021-01-31#ProductMember http://fasb.org/us-gaap/2021-01-31#ProductMember P6Y9M7D P5Y11M23D P5Y8M19D P5Y11M23D 0001642545 2021-01-01 2021-09-30 xbrli:shares 0001642545 2021-11-02 iso4217:USD 0001642545 2021-09-30 0001642545 2020-12-31 0001642545 2021-07-01 2021-09-30 0001642545 2020-07-01 2020-09-30 0001642545 2020-01-01 2020-09-30 iso4217:USD xbrli:shares 0001642545 us-gaap:CommonStockMember 2020-12-31 0001642545 us-gaap:AdditionalPaidInCapitalMember 2020-12-31 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-12-31 0001642545 us-gaap:RetainedEarningsMember 2020-12-31 0001642545 us-gaap:CommonStockMember 2021-01-01 2021-03-31 0001642545 us-gaap:AdditionalPaidInCapitalMember 2021-01-01 2021-03-31 0001642545 2021-01-01 2021-03-31 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-01-01 2021-03-31 0001642545 us-gaap:RetainedEarningsMember 2021-01-01 2021-03-31 0001642545 us-gaap:CommonStockMember 2021-03-31 0001642545 us-gaap:AdditionalPaidInCapitalMember 2021-03-31 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-03-31 0001642545 us-gaap:RetainedEarningsMember 2021-03-31 0001642545 2021-03-31 0001642545 us-gaap:CommonStockMember 2021-04-01 2021-06-30 0001642545 us-gaap:AdditionalPaidInCapitalMember 2021-04-01 2021-06-30 0001642545 2021-04-01 2021-06-30 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-04-01 2021-06-30 0001642545 us-gaap:RetainedEarningsMember 2021-04-01 2021-06-30 0001642545 us-gaap:CommonStockMember 2021-06-30 0001642545 us-gaap:AdditionalPaidInCapitalMember 2021-06-30 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-06-30 0001642545 us-gaap:RetainedEarningsMember 2021-06-30 0001642545 2021-06-30 0001642545 us-gaap:CommonStockMember 2021-07-01 2021-09-30 0001642545 us-gaap:AdditionalPaidInCapitalMember 2021-07-01 2021-09-30 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-07-01 2021-09-30 0001642545 us-gaap:RetainedEarningsMember 2021-07-01 2021-09-30 0001642545 us-gaap:CommonStockMember 2021-09-30 0001642545 us-gaap:AdditionalPaidInCapitalMember 2021-09-30 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-09-30 0001642545 us-gaap:RetainedEarningsMember 2021-09-30 0001642545 us-gaap:CommonStockMember 2019-12-31 0001642545 us-gaap:AdditionalPaidInCapitalMember 2019-12-31 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-12-31 0001642545 us-gaap:RetainedEarningsMember 2019-12-31 0001642545 2019-12-31 0001642545 us-gaap:CommonStockMember 2020-01-01 2020-03-31 0001642545 us-gaap:AdditionalPaidInCapitalMember 2020-01-01 2020-03-31 0001642545 2020-01-01 2020-03-31 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-01-01 2020-03-31 0001642545 us-gaap:RetainedEarningsMember 2020-01-01 2020-03-31 0001642545 us-gaap:CommonStockMember 2020-03-31 0001642545 us-gaap:AdditionalPaidInCapitalMember 2020-03-31 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-03-31 0001642545 us-gaap:RetainedEarningsMember 2020-03-31 0001642545 2020-03-31 0001642545 us-gaap:CommonStockMember 2020-04-01 2020-06-30 0001642545 us-gaap:AdditionalPaidInCapitalMember 2020-04-01 2020-06-30 0001642545 2020-04-01 2020-06-30 0001642545 us-gaap:CommonStockMember us-gaap:OverAllotmentOptionMember 2020-04-01 2020-06-30 0001642545 us-gaap:AdditionalPaidInCapitalMember us-gaap:OverAllotmentOptionMember 2020-04-01 2020-06-30 0001642545 us-gaap:OverAllotmentOptionMember 2020-04-01 2020-06-30 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-04-01 2020-06-30 0001642545 us-gaap:RetainedEarningsMember 2020-04-01 2020-06-30 0001642545 us-gaap:CommonStockMember 2020-06-30 0001642545 us-gaap:AdditionalPaidInCapitalMember 2020-06-30 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-06-30 0001642545 us-gaap:RetainedEarningsMember 2020-06-30 0001642545 2020-06-30 0001642545 us-gaap:CommonStockMember 2020-07-01 2020-09-30 0001642545 us-gaap:AdditionalPaidInCapitalMember 2020-07-01 2020-09-30 0001642545 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-07-01 2020-09-30 0001642545 us-gaap:RetainedEarningsMember 2020-07-01 2020-09-30 0001642545 us-gaap:CommonStockMember 2020-09-30 0001642545 us-gaap:AdditionalPaidInCapitalMember 2020-09-30 0001642545 us-gaap:RetainedEarningsMember 2020-09-30 0001642545 2020-09-30 0001642545 us-gaap:LicenseMember 2021-01-01 2021-09-30 0001642545 us-gaap:LicenseMember 2021-07-01 2021-09-30 0001642545 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2021-09-30 0001642545 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2021-09-30 0001642545 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2021-09-30 0001642545 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2021-09-30 0001642545 us-gaap:CommercialPaperMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2021-09-30 0001642545 us-gaap:CommercialPaperMember us-gaap:FairValueMeasurementsRecurringMember 2021-09-30 0001642545 us-gaap:CorporateBondSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2021-09-30 0001642545 us-gaap:CorporateBondSecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2021-09-30 0001642545 us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2021-09-30 0001642545 us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2021-09-30 0001642545 us-gaap:FairValueMeasurementsRecurringMember 2021-09-30 0001642545 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2020-12-31 0001642545 us-gaap:USTreasurySecuritiesMember us-gaap:FairValueMeasurementsRecurringMember 2020-12-31 0001642545 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2020-12-31 0001642545 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2020-12-31 0001642545 us-gaap:CommercialPaperMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2020-12-31 0001642545 us-gaap:CommercialPaperMember us-gaap:FairValueMeasurementsRecurringMember 2020-12-31 0001642545 us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2020-12-31 0001642545 us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel2Member 2020-12-31 0001642545 us-gaap:FairValueMeasurementsRecurringMember 2020-12-31 0001642545 us-gaap:MoneyMarketFundsMember 2021-09-30 0001642545 us-gaap:USTreasurySecuritiesMember 2021-09-30 0001642545 us-gaap:CommercialPaperMember 2021-09-30 0001642545 us-gaap:CorporateBondSecuritiesMember 2021-09-30 0001642545 us-gaap:MoneyMarketFundsMember 2020-12-31 0001642545 us-gaap:USTreasurySecuritiesMember 2020-12-31 0001642545 us-gaap:CommercialPaperMember 2020-12-31 utr:sqft 0001642545 swav:FiveThousandAndFourHundredZeroThreeBetsyRoseDriveMember swav:SantaClaraMember 2018-05-31 0001642545 swav:FiveThousandAndFourHundredZeroThreeBetsyRoseDriveMember swav:SantaClaraMember 2018-05-01 2018-05-31 0001642545 swav:FiveThousandAndFourHundredZeroThreeBetsyRoseDriveMember swav:SantaClaraMember 2021-09-30 0001642545 swav:FiveThousandAndFourHundredZeroThreeBetsyRoseDriveMember swav:SantaClaraMember 2021-01-01 2021-09-30 0001642545 swav:FiveThousandAndThreeHundredFiftyThreeBetsyRoseDriveMember swav:SantaClaraMember 2019-12-31 0001642545 swav:FiveThousandAndThreeHundredFiftyThreeBetsyRoseDriveMember swav:SantaClaraMember 2019-12-01 2019-12-31 0001642545 swav:FiveThousandAndThreeHundredFiftyThreeBetsyRoseDriveMember swav:SantaClaraMember 2019-01-01 2019-12-31 0001642545 swav:SantaClaraMember swav:FiveThousandThreeHundredFiftyThreeAndFiveThousandFourHundredZeroThreeBetsyRoseDriveMember srt:MaximumMember 2019-12-31 0001642545 swav:SantaClaraMember swav:FiveThousandAndThreeHundredFiftyThreeBetsyRoseDriveMember swav:InitialSecurityDepositMember 2019-12-31 0001642545 swav:SantaClaraMember swav:FiveThousandAndThreeHundredFiftyThreeBetsyRoseDriveMember srt:ScenarioForecastMember 2022-09-01 0001642545 swav:SantaClaraMember swav:FiveThousandAndThreeHundredFiftyThreeBetsyRoseDriveMember 2021-09-01 2021-09-30 0001642545 swav:SantaClaraMember srt:ScenarioForecastMember swav:FiveThousandAndFourHundredZeroThreeBetsyRoseDriveMember 2023-06-01 0001642545 swav:FiveThousandAndThreeHundredFiftyThreeBetsyRoseDriveMember swav:SantaClaraMember 2021-09-30 0001642545 swav:FiveThousandAndThreeHundredFiftyThreeBetsyRoseDriveMember swav:SantaClaraMember 2021-01-01 2021-09-30 0001642545 swav:ThreeZeroZeroThreeBunkerHillLaneMember swav:SantaClaraMember 2021-09-30 0001642545 swav:ThreeZeroZeroThreeBunkerHillLaneMember swav:SantaClaraMember srt:MaximumMember 2021-09-30 0001642545 swav:ThreeZeroZeroThreeBunkerHillLaneMember swav:SantaClaraMember swav:InitialSecurityDepositMember 2021-09-30 0001642545 swav:ThreeZeroZeroThreeBunkerHillLaneMember swav:SantaClaraMember 2021-09-01 2021-09-30 swav:Option 0001642545 country:DE 2021-09-30 xbrli:pure 0001642545 country:DE 2021-01-01 2021-09-30 0001642545 swav:FiveThousandAndFourHundredZeroThreeBetsyRoseDriveAndThreeThousandThreeBunkerHillLaneMember 2021-09-30 0001642545 swav:LoanAndSecurityAgreementMember swav:SiliconValleyBankMember swav:ShortTermNotesMember 2018-02-28 0001642545 swav:LoanAndSecurityAgreementMember swav:SiliconValleyBankMember us-gaap:RevolvingCreditFacilityMember 2018-02-28 0001642545 swav:LoanAndSecurityAgreementMember swav:SiliconValleyBankMember swav:ShortTermNotesMember swav:TrancheOneMember 2018-06-30 0001642545 swav:LoanAndSecurityAgreementMember swav:SiliconValleyBankMember swav:ShortTermNotesMember swav:TrancheTwoMember 2018-12-31 0001642545 swav:LoanAndSecurityAgreementMember srt:MinimumMember 2021-09-30 0001642545 swav:LoanAndSecurityAgreementMember srt:MaximumMember 2021-01-01 2021-09-30 0001642545 swav:LoanAndSecurityAgreementMember 2021-01-01 2021-09-30 0001642545 swav:LoanAndSecurityAgreementMember 2018-02-28 0001642545 swav:LoanAndSecurityAgreementMember swav:SiliconValleyBankMember 2021-09-30 0001642545 swav:LoanAndSecurityAgreementMember us-gaap:RevolvingCreditFacilityMember 2020-02-29 2020-02-29 0001642545 swav:LoanAndSecurityAgreementMember srt:MaximumMember us-gaap:RevolvingCreditFacilityMember 2020-02-29 2020-02-29 0001642545 swav:LoanAndSecurityAgreementMember swav:SupplementalTermLoanMember 2020-02-29 0001642545 swav:LoanAndSecurityAgreementMember swav:SupplementalTermLoanMember 2020-02-29 2020-02-29 0001642545 swav:LoanAndSecurityAgreementMember 2020-02-29 2020-02-29 0001642545 swav:LoanAndSecurityAgreementMember us-gaap:PrimeRateMember srt:MinimumMember swav:SupplementalTermLoanMember 2020-02-29 2020-02-29 0001642545 swav:LoanAndSecurityAgreementMember srt:MaximumMember swav:SupplementalTermLoanMember 2020-02-29 0001642545 swav:LoanAndSecurityAgreementMember swav:SupplementalTermLoanMember 2021-09-30 0001642545 us-gaap:CostOfSalesMember 2021-07-01 2021-09-30 0001642545 us-gaap:CostOfSalesMember 2020-07-01 2020-09-30 0001642545 us-gaap:CostOfSalesMember 2021-01-01 2021-09-30 0001642545 us-gaap:CostOfSalesMember 2020-01-01 2020-09-30 0001642545 us-gaap:ResearchAndDevelopmentExpenseMember 2021-07-01 2021-09-30 0001642545 us-gaap:ResearchAndDevelopmentExpenseMember 2020-07-01 2020-09-30 0001642545 us-gaap:ResearchAndDevelopmentExpenseMember 2021-01-01 2021-09-30 0001642545 us-gaap:ResearchAndDevelopmentExpenseMember 2020-01-01 2020-09-30 0001642545 us-gaap:SellingAndMarketingExpenseMember 2021-07-01 2021-09-30 0001642545 us-gaap:SellingAndMarketingExpenseMember 2020-07-01 2020-09-30 0001642545 us-gaap:SellingAndMarketingExpenseMember 2021-01-01 2021-09-30 0001642545 us-gaap:SellingAndMarketingExpenseMember 2020-01-01 2020-09-30 0001642545 us-gaap:GeneralAndAdministrativeExpenseMember 2021-07-01 2021-09-30 0001642545 us-gaap:GeneralAndAdministrativeExpenseMember 2020-07-01 2020-09-30 0001642545 us-gaap:GeneralAndAdministrativeExpenseMember 2021-01-01 2021-09-30 0001642545 us-gaap:GeneralAndAdministrativeExpenseMember 2020-01-01 2020-09-30 0001642545 swav:TwoThousandAndNineteenEquityIncentivePlanMember 2019-02-28 0001642545 swav:TwoThousandAndNineteenEquityIncentivePlanMember 2019-02-01 2019-02-28 0001642545 swav:TwoThousandAndNineteenEquityIncentivePlanMember 2021-09-30 0001642545 2020-01-01 2020-12-31 0001642545 us-gaap:RestrictedStockUnitsRSUMember 2021-01-01 2021-09-30 0001642545 us-gaap:RestrictedStockUnitsRSUMember 2020-12-31 0001642545 us-gaap:RestrictedStockUnitsRSUMember 2021-09-30 0001642545 swav:TwoThousandAndNineteenEmployeesStockPurchasePlanMember 2019-03-06 0001642545 swav:TwoThousandAndNineteenEmployeesStockPurchasePlanMember 2021-01-01 2021-09-30 0001642545 swav:TwoThousandAndNineteenEmployeesStockPurchasePlanMember 2021-07-01 2021-09-30 0001642545 swav:TwoThousandAndNineteenEmployeesStockPurchasePlanMember 2020-07-01 2020-09-30 0001642545 swav:TwoThousandAndNineteenEmployeesStockPurchasePlanMember 2020-01-01 2020-09-30 0001642545 swav:TwoThousandAndNineteenEmployeesStockPurchasePlanMember 2021-09-30 0001642545 us-gaap:EmployeeStockOptionMember 2020-07-01 2020-09-30 0001642545 us-gaap:EmployeeStockOptionMember 2021-01-01 2021-09-30 0001642545 us-gaap:EmployeeStockOptionMember 2020-01-01 2020-09-30 0001642545 us-gaap:RestrictedStockUnitsRSUMember 2021-07-01 2021-09-30 0001642545 us-gaap:RestrictedStockUnitsRSUMember 2020-07-01 2020-09-30 0001642545 us-gaap:RestrictedStockUnitsRSUMember 2021-01-01 2021-09-30 0001642545 us-gaap:RestrictedStockUnitsRSUMember 2020-01-01 2020-09-30 0001642545 us-gaap:EmployeeStockMember 2021-07-01 2021-09-30 0001642545 us-gaap:EmployeeStockMember 2020-07-01 2020-09-30 0001642545 us-gaap:EmployeeStockMember 2021-01-01 2021-09-30 0001642545 us-gaap:EmployeeStockMember 2020-01-01 2020-09-30 0001642545 swav:CoronaryMember 2021-07-01 2021-09-30 0001642545 swav:CoronaryMember 2020-07-01 2020-09-30 0001642545 swav:CoronaryMember 2021-01-01 2021-09-30 0001642545 swav:CoronaryMember 2020-01-01 2020-09-30 0001642545 swav:PeripheralMember 2021-07-01 2021-09-30 0001642545 swav:PeripheralMember 2020-07-01 2020-09-30 0001642545 swav:PeripheralMember 2021-01-01 2021-09-30 0001642545 swav:PeripheralMember 2020-01-01 2020-09-30 0001642545 swav:OtherProductLineMember 2021-07-01 2021-09-30 0001642545 swav:OtherProductLineMember 2020-07-01 2020-09-30 0001642545 swav:OtherProductLineMember 2021-01-01 2021-09-30 0001642545 swav:OtherProductLineMember 2020-01-01 2020-09-30 0001642545 country:US 2021-07-01 2021-09-30 0001642545 country:US 2020-07-01 2020-09-30 0001642545 country:US 2021-01-01 2021-09-30 0001642545 country:US 2020-01-01 2020-09-30 0001642545 srt:EuropeMember 2021-07-01 2021-09-30 0001642545 srt:EuropeMember 2020-07-01 2020-09-30 0001642545 srt:EuropeMember 2021-01-01 2021-09-30 0001642545 srt:EuropeMember 2020-01-01 2020-09-30 0001642545 swav:AllOtherCountriesMember 2021-07-01 2021-09-30 0001642545 swav:AllOtherCountriesMember 2020-07-01 2020-09-30 0001642545 swav:AllOtherCountriesMember 2021-01-01 2021-09-30 0001642545 swav:AllOtherCountriesMember 2020-01-01 2020-09-30 0001642545 swav:JVAgreementWithGenesisMedTechMember swav:ShareSubscriptionAgreementMember 2021-03-19 2021-03-19 0001642545 swav:JVAgreementWithGenesisMedTechMember swav:ShareSubscriptionAgreementMember 2021-03-19 0001642545 swav:JVAgreementWithGenesisMedTechMember swav:LicenseAgreementMember 2021-03-19 2021-03-19 0001642545 swav:JVAgreementWithGenesisMedTechMember swav:LicenseAgreementMember 2021-03-19 0001642545 us-gaap:CoVenturerMember 2021-03-19 0001642545 us-gaap:CoVenturerMember 2021-03-19 2021-03-19 0001642545 us-gaap:CoVenturerMember 2021-09-30 0001642545 swav:JVAgreementWithGenesisMedTechMember 2021-09-30 0001642545 swav:JVAgreementWithGenesisMedTechMember 2021-07-01 2021-09-30 0001642545 swav:JVAgreementWithGenesisMedTechMember 2021-01-01 2021-09-30

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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: 001-38829

 

Shockwave Medical, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

27-0494101

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

5403 Betsy Ross Drive

Santa Clara, California

95054

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (510) 279-4262

 

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

 

Title of each class of securities

Trading symbol(s)

Name of each national exchange and principal

U.S. market for the securities

Shockwave Medical, Inc., common stock,

par value $0.001 per share

SWAV

The Nasdaq Stock Market LLC

(Nasdaq Global Select Market)

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

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 Exchange Act).    Yes      No 

As of November 2, 2021, the registrant had 35,304,469 shares of common stock, $0.001 par value per share, outstanding.

 

 

 

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

4

Item 1.

Financial Statements (Unaudited)

4

 

Condensed Consolidated Balance Sheets

4

 

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

5

 

Condensed Consolidated Statements of Stockholders’ Equity

6

 

Condensed Consolidated Statements of Cash Flows

8

 

Notes to Unaudited Condensed Consolidated Financial Statements

9

Item 2.

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

22

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

33

Item 4.

Controls and Procedures

34

PART II.

OTHER INFORMATION

35

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

36

Item 3.

Defaults Upon Senior Securities

36

Item 4.

Mine Safety Disclosures

36

Item 5.

Other Information

36

Item 6.

Exhibits

37

Signatures

39

 

 

 

2


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains statements relating to our expectations, projections, beliefs, and prospects, which are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify these statements by forward-looking words such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “might”, “plan,” “expect,” “predict,” “could,” “potentially” or the negative of these terms or similar expressions. You should read these statements carefully because they may relate to future expectations around growth, strategy, and anticipated trends in our business, contain projections of future results of operations or financial condition, or state other “forward-looking” information. These statements are only predictions based on our current expectations, estimates, assumptions, and projections about future events and are applicable only as of the dates of such statements.  These forward-looking statements are subject to certain risks and uncertainties that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Factors that might cause such a difference include, but are not limited to the following:

 

the impact of the COVID-19 pandemic on our operations, financial results, and liquidity and capital resources, including due to the pandemic’s impact on our sales, expenses, supply chain, manufacturing, research and development activities, clinical trials, and employees;

 

our ability to design, develop, manufacture and market innovative products to treat patients with challenging medical conditions, particularly in peripheral artery disease, coronary artery disease and aortic stenosis;

 

our expected future growth, including growth in international sales;

 

the size and growth potential of the markets for our products, and our ability to serve those markets;

 

the rate and degree of market acceptance of our products;

 

coverage and reimbursement for procedures performed using our products;

 

the performance of third parties in connection with the development of our products, including third-party suppliers;

 

regulatory developments in the United States and foreign countries;

 

our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines;

 

our plans to research, develop and commercialize our products and any other approved or cleared product;

 

our ability to scale our organizational culture of cooperative product development and commercial execution;

 

the development, regulatory approval, efficacy and commercialization of competing products;

 

the loss of key scientific or management personnel;

 

our ability to develop and maintain our corporate infrastructure, including our internal controls;

 

our financial performance and capital requirements; and

 

our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others.

These factors and others are discussed in more detail in the section entitled “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2020, together with any updates in the section entitled “Risk Factors” of our Quarterly Report on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021 and in this Quarterly Report on Form 10-Q. Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. There may also be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. We undertake no obligation to update any of these forward-looking statements for any reason, even if new information becomes available in the future, except as may be required by law.

 

3


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

SHOCKWAVE MEDICAL, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands)

 

 

 

September 30,

2021

 

 

December 31,

2020

 

 

 

 

 

 

 

(1)

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

91,195

 

 

$

50,423

 

Short-term investments

 

 

91,759

 

 

 

151,931

 

Accounts receivable, net

 

 

29,966

 

 

 

11,689

 

Inventory

 

 

38,744

 

 

 

29,859

 

Prepaid expenses and other current assets

 

 

4,364

 

 

 

2,398

 

Total current assets

 

 

256,028

 

 

 

246,300

 

Operating lease right-of-use assets

 

 

11,790

 

 

 

7,568

 

Property and equipment, net

 

 

23,085

 

 

 

16,362

 

Equity method investment

 

 

6,408

 

 

 

 

Other assets

 

 

1,684

 

 

 

1,812

 

TOTAL ASSETS

 

$

298,995

 

 

$

272,042

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,632

 

 

$

1,466

 

Term notes, current portion

 

 

2,750

 

 

 

3,300

 

Accrued liabilities

 

 

33,017

 

 

 

19,942

 

Lease liability, current portion

 

 

867

 

 

 

873

 

Total current liabilities

 

 

40,266

 

 

 

25,581

 

Lease liability, noncurrent portion

 

 

11,939

 

 

 

7,488

 

Term notes, noncurrent portion

 

 

14,226

 

 

 

13,319

 

Related party contract liability, noncurrent portion

 

 

12,273

 

 

 

 

TOTAL LIABILITIES

 

 

78,704

 

 

 

46,388

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

35

 

 

 

35

 

Additional paid-in capital

 

 

486,014

 

 

 

469,283

 

Accumulated other comprehensive income (loss)

 

 

(7

)

 

 

9

 

Accumulated deficit

 

 

(265,751

)

 

 

(243,673

)

TOTAL STOCKHOLDERS’ EQUITY

 

 

220,291

 

 

 

225,654

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

298,995

 

 

$

272,042

 

 

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

(1)

The consolidated balance sheet as of December 31, 2020 is derived from the audited consolidated financial statements as of that date.

 

4


 

SHOCKWAVE MEDICAL, INC.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

65,155

 

 

$

19,590

 

 

$

152,963

 

 

$

45,073

 

Cost of revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

 

10,949

 

 

 

5,277

 

 

 

28,775

 

 

 

14,520

 

Gross profit

 

 

54,206

 

 

 

14,313

 

 

 

124,188

 

 

 

30,553

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

13,735

 

 

 

7,891

 

 

 

35,827

 

 

 

27,882

 

Sales and marketing

 

 

28,393

 

 

 

13,619

 

 

 

78,098

 

 

 

35,236

 

General and administrative

 

 

9,265

 

 

 

5,610

 

 

 

25,117

 

 

 

17,232

 

Total operating expenses

 

 

51,393

 

 

 

27,120

 

 

 

139,042

 

 

 

80,350

 

Income (loss) from operations

 

 

2,813

 

 

 

(12,807

)

 

 

(14,854

)

 

 

(49,797

)

Share in net loss of equity method investment

 

 

(342

)

 

 

 

 

 

(5,865

)

 

 

 

Interest expense

 

 

(165

)

 

 

(314

)

 

 

(795

)

 

 

(897

)

Other income (expense), net

 

 

(280

)

 

 

218

 

 

 

(369

)

 

 

942

 

Net income (loss) before taxes

 

 

2,026

 

 

 

(12,903

)

 

 

(21,883

)

 

 

(49,752

)

Income tax provision

 

 

78

 

 

 

29

 

 

 

195

 

 

 

73

 

Net income (loss)

 

$

1,948

 

 

$

(12,932

)

 

$

(22,078

)

 

$

(49,825

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

(17

)

 

 

 

 

 

(16

)

 

 

(14

)

Adjustment for net gain realized and included in other income, net

 

 

 

 

 

(21

)

 

 

 

 

 

(21

)

Total other comprehensive income (loss)

 

 

(17

)

 

 

(21

)

 

 

(16

)

 

 

(35

)

Total comprehensive income (loss)

 

$

1,931

 

 

$

(12,953

)

 

$

(22,094

)

 

$

(49,860

)

Net income (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.06

 

 

$

(0.38

)

 

$

(0.63

)

 

$

(1.53

)

Diluted

 

$

0.05

 

 

$

(0.38

)

 

$

(0.63

)

 

$

(1.53

)

Shares used in computing net income (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

35,207,276

 

 

 

34,078,726

 

 

 

35,013,072

 

 

 

32,631,715

 

Diluted

 

 

37,567,176

 

 

 

34,078,726

 

 

 

35,013,072

 

 

 

32,631,715

 

 

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

 

 

 

5


 

 

Shockwave Medical, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share data)

 

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Deficit

 

 

Equity

 

 

Balance — December 31, 2020

 

 

34,684,337

 

 

$

35

 

 

$

469,283

 

 

$

9

 

 

$

(243,673

)

 

$

225,654

 

 

Exercise of stock options

 

 

159,325

 

 

 

 

 

 

773

 

 

 

 

 

 

 

 

 

773

 

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

7

 

 

Issuance of common stock under employee stock purchase plan

 

 

20,594

 

 

 

 

 

 

1,141

 

 

 

 

 

 

 

 

 

1,141

 

 

Issuance of common stock in connection with vesting of restricted stock units

 

 

107,237

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Taxes withheld on net settled vesting of restricted stock units

 

 

(42,529

)

 

 

 

 

 

(5,114

)

 

 

 

 

 

 

 

 

(5,114

)

 

Stock-based compensation

 

 

 

 

 

 

 

 

5,394

 

 

 

 

 

 

 

 

 

5,394

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(23,601

)

 

 

(23,601

)

 

Balance — March 31, 2021

 

 

34,928,964

 

 

 

35

 

 

 

471,477

 

 

 

16

 

 

 

(267,274

)

 

 

204,254

 

 

Exercise of stock options

 

 

149,101

 

 

 

 

 

 

1,085

 

 

 

 

 

 

 

 

 

1,085

 

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(6

)

 

 

 

 

 

(6

)

 

Issuance of common stock in connection with vesting of restricted stock units

 

 

71,761

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Taxes withheld on net settled vesting

   of restricted stock units

 

 

(20,537

)

 

 

 

 

 

(3,223

)

 

 

 

 

 

 

 

 

(3,223

)

 

Stock-based compensation

 

 

 

 

 

 

 

 

6,662

 

 

 

 

 

 

 

 

 

6,662

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(425

)

 

 

(425

)

 

Balance — June 30, 2021

 

 

35,129,289

 

 

 

35

 

 

 

476,001

 

 

 

10

 

 

 

(267,699

)

 

 

208,347

 

 

Exercise of stock options

 

 

122,615

 

 

 

 

 

 

691

 

 

 

 

 

 

 

 

 

691

 

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(17

)

 

 

 

 

 

(17

)

 

Issuance of common stock under employee stock purchase plan

 

 

16,239

 

 

 

 

 

 

1,696

 

 

 

 

 

 

 

 

 

1,696

 

 

Issuance of common stock in connection with vesting of restricted stock units

 

 

26,809

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

7,626

 

 

 

 

 

 

 

 

 

7,626

 

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,948

 

 

 

1,948

 

 

Balance — September 30, 2021

 

 

35,294,952

 

 

$

35

 

 

$

486,014

 

 

$

(7

)

 

$

(265,751

)

 

$

220,291

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

6


 

 

Shockwave Medical, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share data)

 

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Deficit

 

 

Equity

 

 

Balance — December 31, 2019

 

 

31,446,787

 

 

$

31

 

 

$

370,561

 

 

$

35

 

 

$

(177,974

)

 

$

192,653

 

 

Exercise of stock options

 

 

356,128

 

 

 

1

 

 

 

1,112

 

 

 

 

 

 

 

 

 

1,113

 

 

Issuance of common stock under employee stock purchase plan

 

 

24,691

 

 

 

 

 

 

842

 

 

 

 

 

 

 

 

 

842

 

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

68

 

 

 

 

 

 

68

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,871

 

 

 

 

 

 

 

 

 

1,871

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,775

)

 

 

(18,775

)

 

Balance — March 31, 2020

 

 

31,827,606

 

 

 

32

 

 

 

374,386

 

 

 

103

 

 

 

(196,749

)

 

 

177,772

 

 

Exercise of stock options

 

 

137,178

 

 

 

 

 

 

480

 

 

 

 

 

 

 

 

 

480

 

 

Issuance of common stock in connection with public offering, net of issuance costs of $6.1 million

 

 

1,955,000

 

 

 

2

 

 

 

83,380

 

 

 

 

 

 

 

 

 

83,382

 

 

Issuance of common stock in connection with vesting of restricted stock units

 

 

41,229

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Restricted stock units withheld in net settlement for tax

 

 

(15,456

)

 

 

 

 

 

(616

)

 

 

 

 

 

 

 

 

(616

)

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(82

)

 

 

 

 

 

(82

)

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,605

 

 

 

 

 

 

 

 

 

2,605

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,118

)

 

 

(18,118

)

 

Balance — June 30, 2020

 

 

33,945,557

 

 

 

34

 

 

 

460,235

 

 

 

21

 

 

 

(214,867

)

 

 

245,423

 

 

Exercise of stock options