10-Q
Q2--12-310001674930falseJuly 31 2027P3Yhttp://fasb.org/us-gaap/2024#UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMemberhttp://fasb.org/us-gaap/2024#OtherAssetsNoncurrenthttp://fasb.org/us-gaap/2024#OtherAssetsNoncurrenthttp://fasb.org/us-gaap/2024#AccruedLiabilitiesCurrenthttp://fasb.org/us-gaap/2024#AccruedLiabilitiesCurrenthttp://fasb.org/us-gaap/2024#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2024#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2024#OtherAssetsNoncurrenthttp://fasb.org/us-gaap/2024#OtherAssetsNoncurrenthttp://fasb.org/us-gaap/2024#AccruedLiabilitiesCurrenthttp://fasb.org/us-gaap/2024#AccruedLiabilitiesCurrenthttp://fasb.org/us-gaap/2024#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2024#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2024#RelatedPartyMemberhttp://fasb.org/us-gaap/2024#RelatedPartyMember00016749302023-12-310001674930country:US2023-01-012023-06-300001674930flgt:TherapeuticDevelopmentMember2024-04-012024-06-300001674930flgt:LaboratoryServicesMemberflgt:PurchasedPatentMember2024-01-012024-06-300001674930flgt:ShortTermMarketableSecuritesMemberus-gaap:AgencySecuritiesMember2023-12-310001674930flgt:OtherCountriesMember2024-01-012024-06-300001674930us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930us-gaap:NoncontrollingInterestMember2022-12-310001674930flgt:DebtSecuritiesDueAfterFiveYearsThroughTenYearsMemberus-gaap:MunicipalBondsMember2023-12-310001674930us-gaap:BuildingImprovementsMember2023-12-310001674930us-gaap:RestrictedStockUnitsRSUMember2024-01-012024-06-300001674930us-gaap:FairValueMeasurementsRecurringMemberflgt:USAgencyDebtSecuritiesMember2023-12-310001674930flgt:InsuranceCustomerMember2023-12-310001674930us-gaap:RetainedEarningsMember2023-06-300001674930us-gaap:ParentMember2023-12-310001674930us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930us-gaap:GeneralAndAdministrativeExpenseMember2024-04-012024-06-300001674930us-gaap:BuildingMember2024-01-012024-06-300001674930flgt:LaboratoryServicesMember2024-01-012024-06-300001674930us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930us-gaap:DebtSecuritiesMember2023-12-310001674930flgt:GeneralEquipmentMembersrt:MaximumMember2024-06-300001674930flgt:GeneralEquipmentMembersrt:MinimumMember2024-06-300001674930flgt:Covid19Memberflgt:LaboratoryServicesMember2023-01-012023-06-300001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-06-300001674930us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberflgt:YankeeDebtSecuritiesMember2024-06-300001674930us-gaap:RetainedEarningsMember2024-03-310001674930flgt:LaboratoryServicesMemberus-gaap:TradeNamesMember2024-06-300001674930flgt:LaboratoryServicesMemberflgt:RoyaltyFreeTechnologyMember2023-12-310001674930flgt:GeneticSequencingServiceMemberflgt:AHMCHealthcareIncMember2023-04-012023-06-300001674930us-gaap:LandMember2023-12-3100016749302022-03-310001674930flgt:ShortTermMarketableSecuritesMemberus-gaap:MunicipalBondsMember2023-12-310001674930us-gaap:USGovernmentDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930us-gaap:RestrictedStockUnitsRSUMember2023-01-012023-06-300001674930us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930country:CN2023-04-012023-06-300001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-12-310001674930us-gaap:CommonStockMember2023-04-012023-06-300001674930flgt:AccountingStandardUpdate201409Member2023-01-012023-06-300001674930flgt:TherapeuticDevelopmentMemberflgt:InProcessResearchDevelopmentMember2023-12-3100016749302023-04-012023-06-300001674930flgt:ClinicalInsuranceContractsMemberflgt:AccountingStandardUpdate201409Member2024-04-012024-06-300001674930us-gaap:NoncontrollingInterestMember2023-03-310001674930flgt:AccountingStandardUpdate201409Memberflgt:ClinicalInstitutionalContractsMember2023-01-012023-06-300001674930flgt:BiopharmaServicesMemberflgt:LaboratoryServicesMember2024-04-012024-06-300001674930us-gaap:ParentMember2024-01-012024-03-310001674930us-gaap:BuildingMember2023-12-310001674930flgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMemberus-gaap:MunicipalBondsMember2023-12-310001674930flgt:Covid19Memberflgt:LaboratoryServicesMember2024-01-012024-06-300001674930flgt:InstallmentSaleContractMember2024-06-300001674930flgt:LaboratoryInformationSystemPlatformMemberflgt:LaboratoryServicesMember2024-06-300001674930us-gaap:USGovernmentDebtSecuritiesMemberflgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMember2023-12-310001674930us-gaap:CommonStockMember2024-01-012024-03-310001674930flgt:OtherCountriesMember2023-01-012023-06-300001674930flgt:HealthResourcesAndServicesAdministrationUninsuredProgramMember2021-01-012021-12-3100016749302023-01-012023-06-300001674930us-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMemberflgt:CustomerOneMember2024-01-012024-06-300001674930us-gaap:CorporateDebtSecuritiesMemberflgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMember2023-12-310001674930flgt:TherapeuticDevelopmentMember2024-01-012024-06-300001674930flgt:LaboratoryServicesMember2023-01-012023-06-300001674930us-gaap:NoncontrollingInterestMember2023-01-012023-03-310001674930us-gaap:CorporateDebtSecuritiesMemberflgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMember2024-06-300001674930us-gaap:FairValueMeasurementsRecurringMemberflgt:YankeeDebtSecuritiesMember2024-06-300001674930us-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMemberflgt:CustomerOneMember2024-04-012024-06-300001674930flgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMember2023-12-310001674930us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMemberflgt:PreferredStockOfPrivatelyHeldCompanyMember2024-06-3000016749302024-04-012024-06-300001674930flgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMember2024-06-300001674930us-gaap:CommonStockMember2024-04-012024-06-300001674930country:US2024-01-012024-06-300001674930us-gaap:MoneyMarketFundsMemberflgt:ShortTermMarketableSecuritesMember2023-12-310001674930flgt:ClinicalInsuranceContractsMemberflgt:AccountingStandardUpdate201409Member2023-04-012023-06-300001674930flgt:ANPTechnologiesIncMember2023-12-310001674930us-gaap:RetainedEarningsMember2024-01-012024-03-310001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-01-012023-03-310001674930us-gaap:CommonStockMember2023-01-012023-03-310001674930flgt:LaboratoryServicesMember2023-04-012023-06-300001674930country:US2024-06-300001674930us-gaap:DebtSecuritiesMember2024-06-300001674930us-gaap:NoncontrollingInterestMember2024-04-012024-06-300001674930us-gaap:AdditionalPaidInCapitalMember2024-06-300001674930flgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMemberus-gaap:MunicipalBondsMember2024-06-300001674930flgt:HealthResourcesAndServicesAdministrationUninsuredProgramMember2022-01-012022-12-310001674930us-gaap:RedeemablePreferredStockMemberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930srt:MaximumMemberus-gaap:SoftwareDevelopmentMember2024-06-300001674930flgt:LaboratoryServicesMemberus-gaap:TradeNamesMember2024-01-012024-06-300001674930flgt:TherapeuticDevelopmentMember2023-12-310001674930flgt:MedicalLabEquipmentMember2024-06-300001674930us-gaap:NoncontrollingInterestMember2023-04-012023-06-300001674930us-gaap:ParentMember2022-12-310001674930flgt:OtherCountriesMember2024-04-012024-06-300001674930flgt:LaboratoryServicesMemberflgt:RoyaltyFreeTechnologyMember2024-01-012024-06-300001674930us-gaap:ResearchAndDevelopmentExpenseMember2023-04-012023-06-300001674930us-gaap:AdditionalPaidInCapitalMember2024-03-310001674930us-gaap:LandImprovementsMember2023-12-310001674930flgt:GeneticSequencingServiceMemberflgt:AHMCHealthcareIncMember2023-01-012023-06-300001674930us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberflgt:YankeeDebtSecuritiesMember2023-12-310001674930us-gaap:CommonStockMember2023-03-310001674930us-gaap:CommonStockMember2023-06-300001674930us-gaap:FairValueInputsLevel3Memberus-gaap:RedeemablePreferredStockMemberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930flgt:LaboratoryServicesMemberflgt:PrecisionDiagnosticsMember2024-01-012024-06-300001674930us-gaap:FairValueMeasurementsRecurringMemberus-gaap:MunicipalBondsMember2024-06-3000016749302023-11-300001674930us-gaap:FairValueInputsLevel1Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930us-gaap:RedeemablePreferredStockMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930flgt:LaboratoryServicesMemberflgt:AnatomicPathologyMember2023-04-012023-06-300001674930us-gaap:NoncontrollingInterestMember2023-12-310001674930us-gaap:LandMember2024-06-300001674930us-gaap:ResearchAndDevelopmentExpenseMember2024-04-012024-06-300001674930us-gaap:EmployeeStockOptionMember2024-04-012024-06-300001674930flgt:ShortTermMarketableSecuritesMemberus-gaap:USTreasuryBillSecuritiesMember2024-06-300001674930flgt:LaboratoryServicesMemberflgt:RoyaltyFreeTechnologyMember2024-06-300001674930us-gaap:ResearchAndDevelopmentExpenseMember2023-01-012023-06-300001674930us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930flgt:LaboratoryServicesMemberus-gaap:TradeNamesMember2023-12-310001674930us-gaap:USGovernmentDebtSecuritiesMemberus-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930us-gaap:ParentMember2023-04-012023-06-300001674930flgt:InstitutionalCustomerMember2024-06-300001674930flgt:LaboratoryServicesMemberflgt:PrecisionDiagnosticsMember2023-04-012023-06-300001674930flgt:VoluntaryDisclosureProcessMember2023-12-310001674930us-gaap:AdditionalPaidInCapitalMember2023-01-012023-03-310001674930srt:DirectorMemberflgt:AnpTechnologiesIncorporationMember2024-06-300001674930us-gaap:NoncontrollingInterestMember2024-03-310001674930flgt:FFGeneBiotechMemberflgt:XilongScientificMember2023-04-012023-06-300001674930us-gaap:SellingAndMarketingExpenseMember2024-01-012024-06-300001674930us-gaap:NonUsMember2023-04-012023-06-300001674930us-gaap:ParentMember2024-04-012024-06-300001674930srt:MinimumMember2024-06-300001674930us-gaap:ResearchAndDevelopmentExpenseMember2024-01-012024-06-3000016749302024-03-310001674930flgt:HealthResourcesAndServicesAdministrationUninsuredProgramMember2020-01-012020-12-310001674930us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930flgt:DebtSecuritiesDueAfterFiveYearsThroughTenYearsMemberus-gaap:MunicipalBondsMember2024-06-300001674930flgt:GeneralEquipmentMember2024-06-300001674930us-gaap:NonUsMember2023-01-012023-06-300001674930us-gaap:SoftwareDevelopmentMember2024-06-300001674930us-gaap:NoncontrollingInterestMember2024-01-012024-03-310001674930flgt:DebtSecuritiesDueAfterFiveYearsThroughTenYearsMember2024-06-300001674930flgt:ANPTechnologiesIncMember2023-01-012023-06-300001674930flgt:InstallmentSaleContractMember2024-01-012024-06-300001674930flgt:MedicalLabEquipmentMember2023-12-310001674930flgt:ClinicalInsuranceContractsMemberflgt:AccountingStandardUpdate201409Member2024-01-012024-06-300001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-03-310001674930us-gaap:FairValueMeasurementsRecurringMemberus-gaap:MunicipalBondsMember2023-12-3100016749302024-01-012024-06-300001674930us-gaap:FairValueMeasurementsRecurringMemberflgt:USAgencyDebtSecuritiesMember2024-06-300001674930us-gaap:FairValueInputsLevel3Memberus-gaap:RedeemablePreferredStockMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930us-gaap:AdditionalPaidInCapitalMember2024-01-012024-03-310001674930flgt:Covid19Memberflgt:LaboratoryServicesMember2024-04-012024-06-300001674930flgt:AutomobileMember2024-06-300001674930flgt:LaboratoryServicesMemberflgt:PurchasedPatentMember2024-06-300001674930us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:MunicipalBondsMember2023-12-310001674930us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryBillSecuritiesMember2024-06-300001674930us-gaap:FairValueMeasurementsRecurringMemberflgt:PreferredStockOfPrivatelyHeldCompanyMember2024-06-300001674930us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberflgt:USAgencyDebtSecuritiesMember2024-06-300001674930flgt:ClinicalPatientContractsMemberflgt:AccountingStandardUpdate201409Member2024-04-012024-06-300001674930us-gaap:SellingAndMarketingExpenseMember2023-01-012023-06-300001674930us-gaap:FurnitureAndFixturesMembersrt:MaximumMember2024-06-300001674930us-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930flgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMemberflgt:YankeeDebtSecuritiesMember2023-12-310001674930us-gaap:ComputerEquipmentMember2023-12-310001674930us-gaap:EmployeeStockOptionMember2023-04-012023-06-300001674930us-gaap:NonUsMember2024-01-012024-06-300001674930flgt:ClinicalPatientContractsMemberflgt:AccountingStandardUpdate201409Member2023-01-012023-06-300001674930us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMemberflgt:PreferredStockOfPrivatelyHeldCompanyMember2023-12-310001674930us-gaap:AdditionalPaidInCapitalMember2024-04-012024-06-300001674930us-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930flgt:LaboratoryServicesMember2024-04-012024-06-300001674930us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930us-gaap:AdditionalPaidInCapitalMember2023-04-012023-06-300001674930us-gaap:GeneralAndAdministrativeExpenseMember2023-04-012023-06-300001674930flgt:VoluntaryDisclosureProcessMember2024-06-3000016749302023-01-012023-12-310001674930us-gaap:RetainedEarningsMember2024-06-300001674930us-gaap:CostOfSalesMember2023-04-012023-06-300001674930us-gaap:RetainedEarningsMember2024-04-012024-06-300001674930us-gaap:CorporateDebtSecuritiesMemberflgt:ShortTermMarketableSecuritesMember2023-12-310001674930country:CN2023-01-012023-06-300001674930us-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMemberflgt:CustomerOneMember2023-01-012023-12-310001674930us-gaap:AdditionalPaidInCapitalMember2023-06-300001674930flgt:LaboratoryServicesMemberflgt:PrecisionDiagnosticsMember2024-04-012024-06-300001674930flgt:ContingentlyIssuableSharesMember2023-04-012023-06-300001674930flgt:AutomobileMember2023-12-310001674930us-gaap:BuildingMember2024-06-300001674930us-gaap:MoneyMarketFundsMemberflgt:ShortTermMarketableSecuritesMember2024-06-300001674930country:US2023-12-310001674930flgt:LaboratoryServicesMemberflgt:AnatomicPathologyMember2024-01-012024-06-300001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-01-012024-03-310001674930flgt:InstitutionalCustomerMember2023-12-310001674930us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930us-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMemberflgt:CustomerOneMember2023-01-012023-06-300001674930flgt:ShortTermMarketableSecuritesMember2023-12-310001674930flgt:AccountingStandardUpdate201409Memberflgt:ClinicalInstitutionalContractsMember2024-01-012024-06-300001674930country:CN2024-01-012024-06-300001674930us-gaap:AdditionalPaidInCapitalMember2022-12-310001674930srt:MaximumMemberus-gaap:ComputerEquipmentMember2024-06-300001674930flgt:LaboratoryServicesMember2024-06-300001674930us-gaap:ParentMember2024-06-300001674930us-gaap:BuildingImprovementsMembersrt:MaximumMember2024-06-300001674930us-gaap:FurnitureAndFixturesMember2024-06-300001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-12-310001674930flgt:BiopharmaServicesMemberflgt:LaboratoryServicesMember2023-04-012023-06-300001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-04-012023-06-300001674930us-gaap:BuildingImprovementsMembersrt:MinimumMember2024-06-300001674930flgt:DirectorAndOfficerMember2024-04-012024-06-300001674930flgt:AccountingStandardUpdate201409Member2024-01-012024-06-300001674930us-gaap:USGovernmentDebtSecuritiesMemberus-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930us-gaap:AdditionalPaidInCapitalMember2023-03-310001674930us-gaap:CostOfSalesMember2024-01-012024-06-300001674930us-gaap:CorporateDebtSecuritiesMemberflgt:ShortTermMarketableSecuritesMember2024-06-300001674930flgt:FFGeneBiotechMemberflgt:XilongScientificMember2023-01-012023-06-300001674930srt:MinimumMemberflgt:AutomobileMember2024-06-300001674930flgt:TherapeuticDevelopmentMember2024-06-300001674930flgt:FFGeneBiotechMemberflgt:XilongScientificMember2024-04-012024-06-300001674930us-gaap:LeaseholdImprovementsMember2023-12-310001674930us-gaap:SalesRevenueNetMemberus-gaap:CustomerConcentrationRiskMemberflgt:CustomerOneMember2023-04-012023-06-300001674930flgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMemberflgt:RedeemablePreferredStockInvestmentMember2023-12-310001674930us-gaap:CostOfSalesMember2024-04-012024-06-300001674930flgt:TherapeuticDevelopmentMember2023-01-012023-06-300001674930us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryBillSecuritiesMember2023-12-310001674930flgt:InstallmentSaleContractMemberus-gaap:OtherNoncurrentLiabilitiesMember2024-06-3000016749302024-05-310001674930us-gaap:LandImprovementsMembersrt:MaximumMember2024-06-300001674930us-gaap:FairValueMeasurementsRecurringMemberflgt:PreferredStockOfPrivatelyHeldCompanyMember2023-12-310001674930us-gaap:RetainedEarningsMember2023-01-012023-03-310001674930flgt:ShortTermMarketableSecuritesMemberus-gaap:AgencySecuritiesMember2024-06-300001674930flgt:ClinicalPatientContractsMemberflgt:AccountingStandardUpdate201409Member2023-04-012023-06-300001674930flgt:ClinicalPatientContractsMemberflgt:AccountingStandardUpdate201409Member2024-01-012024-06-300001674930flgt:ANPTechnologiesIncMember2024-01-012024-06-300001674930us-gaap:ParentMember2024-03-310001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-06-300001674930us-gaap:LeaseholdImprovementsMember2024-06-300001674930flgt:AccountingStandardUpdate201409Memberflgt:ClinicalInstitutionalContractsMember2023-04-012023-06-300001674930flgt:InsuranceCustomerMember2024-06-3000016749302024-01-012024-03-310001674930us-gaap:NoncontrollingInterestMember2023-06-300001674930us-gaap:RetainedEarningsMember2023-03-310001674930us-gaap:MoneyMarketFundsMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930us-gaap:RestrictedStockUnitsRSUMember2023-04-012023-06-300001674930us-gaap:USGovernmentDebtSecuritiesMemberflgt:ShortTermMarketableSecuritesMember2024-06-300001674930flgt:FFGeneBiotechMemberflgt:XilongScientificMember2024-01-012024-06-300001674930us-gaap:AccountsReceivableMemberus-gaap:CustomerConcentrationRiskMemberflgt:CustomerOneMember2024-01-012024-06-3000016749302023-06-300001674930us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryBillSecuritiesMember2023-12-310001674930flgt:AccountingStandardUpdate201409Member2023-04-012023-06-300001674930flgt:ClinicalInsuranceContractsMemberflgt:AccountingStandardUpdate201409Member2023-01-012023-06-300001674930us-gaap:ComputerEquipmentMember2024-06-3000016749302023-03-310001674930flgt:LaboratoryServicesMemberflgt:AnatomicPathologyMember2023-01-012023-06-300001674930flgt:LaboratoryServicesMemberus-gaap:CustomerRelationshipsMember2023-12-310001674930us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930flgt:ShortTermMarketableSecuritesMemberus-gaap:MunicipalBondsMember2024-06-300001674930us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930us-gaap:NonUsMember2024-04-012024-06-300001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-04-012024-06-300001674930us-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930flgt:BostonMoleculesIncMember2024-06-300001674930us-gaap:EmployeeStockOptionMember2024-01-012024-06-300001674930flgt:AccountingStandardUpdate201409Member2024-04-012024-06-300001674930flgt:LaboratoryServicesMemberflgt:LaboratoryInformationSystemPlatformMember2023-12-310001674930country:US2023-04-012023-06-300001674930us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberflgt:USAgencyDebtSecuritiesMember2023-12-310001674930us-gaap:FurnitureAndFixturesMember2023-12-310001674930flgt:LaboratoryServicesMemberus-gaap:CustomerRelationshipsMember2024-01-012024-06-300001674930flgt:AccountingStandardUpdate201409Memberflgt:ClinicalInstitutionalContractsMember2024-04-012024-06-300001674930flgt:AircraftMember2023-12-310001674930flgt:LaboratoryServicesMember2023-12-310001674930us-gaap:ParentMember2023-01-012023-03-310001674930us-gaap:USGovernmentDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001674930country:CN2024-04-012024-06-300001674930us-gaap:CommonStockMember2024-06-300001674930flgt:AssetsNotYetPlacedInServiceMember2024-06-300001674930flgt:LaboratoryServicesMemberus-gaap:CustomerRelationshipsMember2024-06-300001674930flgt:AutomobileMembersrt:MaximumMember2024-06-300001674930us-gaap:SellingAndMarketingExpenseMember2023-04-012023-06-300001674930us-gaap:GeneralAndAdministrativeExpenseMember2023-01-012023-06-300001674930srt:MinimumMemberus-gaap:LandImprovementsMember2024-06-300001674930us-gaap:NonUsMember2024-06-300001674930flgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMemberus-gaap:AgencySecuritiesMember2023-12-310001674930flgt:ShortTermMarketableSecuritesMember2024-06-300001674930us-gaap:SalesRevenueNetMembersrt:MinimumMemberus-gaap:CustomerConcentrationRiskMemberflgt:CustomerOneMember2023-01-012023-06-300001674930us-gaap:LandImprovementsMember2024-06-300001674930us-gaap:EmployeeStockOptionMember2023-01-012023-06-300001674930flgt:BiopharmaServicesMemberflgt:LaboratoryServicesMember2023-01-012023-06-300001674930us-gaap:CommonStockMember2022-12-310001674930flgt:LaboratoryServicesMemberflgt:InPlaceLeaseIntangibleAssetsMember2024-06-300001674930us-gaap:ParentMember2023-06-300001674930us-gaap:SoftwareDevelopmentMember2023-12-310001674930us-gaap:CommonStockMember2023-12-310001674930srt:MinimumMemberus-gaap:FurnitureAndFixturesMember2024-06-300001674930us-gaap:FairValueMeasurementsRecurringMemberflgt:YankeeDebtSecuritiesMember2023-12-310001674930us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-03-310001674930us-gaap:RetainedEarningsMember2022-12-310001674930flgt:LongTermEquitySecuritiesMember2023-12-310001674930flgt:LaboratoryServicesMemberflgt:PrecisionDiagnosticsMember2023-01-012023-06-300001674930flgt:DebtSecuritiesDueAfterFiveYearsThroughTenYearsMember2023-12-310001674930flgt:ANPTechnologiesIncMember2024-04-012024-06-300001674930flgt:LaboratoryServicesMemberflgt:AnatomicPathologyMember2024-04-012024-06-300001674930flgt:TherapeuticDevelopmentMember2023-04-012023-06-300001674930us-gaap:RetainedEarningsMember2023-12-310001674930flgt:LaboratoryServicesMemberflgt:PurchasedPatentMember2023-12-310001674930us-gaap:GeneralAndAdministrativeExpenseMember2024-01-012024-06-300001674930flgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMemberflgt:YankeeDebtSecuritiesMember2024-06-300001674930us-gaap:ParentMember2023-03-310001674930flgt:GeneralEquipmentMember2023-12-310001674930srt:MinimumMemberus-gaap:SoftwareDevelopmentMember2024-06-300001674930flgt:ANPTechnologiesIncMember2024-06-3000016749302024-07-300001674930us-gaap:BuildingImprovementsMember2024-06-300001674930flgt:AssetsNotYetPlacedInServiceMember2023-12-310001674930flgt:TherapeuticDevelopmentMemberflgt:InProcessResearchDevelopmentMember2024-06-300001674930us-gaap:RestrictedStockUnitsRSUMember2024-04-012024-06-300001674930us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:USTreasuryBillSecuritiesMember2024-06-300001674930flgt:ShortTermMarketableSecuritesMemberus-gaap:USTreasuryBillSecuritiesMember2023-12-310001674930flgt:ContingentlyIssuableSharesMember2023-01-012023-06-3000016749302024-06-300001674930us-gaap:AdditionalPaidInCapitalMember2023-12-310001674930us-gaap:RetainedEarningsMember2023-04-012023-06-300001674930flgt:LongTermEquitySecuritiesMemberflgt:PreferredStockOfPrivatelyHeldCompanyMember2023-12-310001674930us-gaap:CommonStockMember2024-03-310001674930flgt:MedicalLabEquipmentMembersrt:MinimumMember2024-06-300001674930flgt:ANPTechnologiesIncMember2023-04-012023-06-300001674930flgt:LongTermEquitySecuritiesMember2024-06-300001674930flgt:OtherCountriesMember2023-04-012023-06-300001674930us-gaap:USGovernmentDebtSecuritiesMemberflgt:ShortTermMarketableSecuritesMember2023-12-310001674930country:US2024-04-012024-06-300001674930us-gaap:USGovernmentDebtSecuritiesMemberflgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMember2024-06-300001674930flgt:LaboratoryServicesMemberflgt:LaboratoryInformationSystemPlatformMember2024-01-012024-06-300001674930flgt:AircraftMember2024-06-300001674930flgt:Covid19Memberflgt:LaboratoryServicesMember2023-04-012023-06-300001674930us-gaap:NoncontrollingInterestMember2024-06-300001674930us-gaap:CostOfSalesMember2023-01-012023-06-300001674930srt:MinimumMemberus-gaap:ComputerEquipmentMember2024-06-300001674930srt:MaximumMember2024-06-300001674930flgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMemberflgt:RedeemablePreferredStockInvestmentMember2024-06-300001674930us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-06-300001674930us-gaap:AgencySecuritiesMemberflgt:DebtSecuritiesDueAfterOneYearThroughFiveYearsMember2024-06-3000016749302023-01-012023-03-310001674930us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMemberus-gaap:MunicipalBondsMember2024-06-300001674930flgt:LaboratoryServicesMemberflgt:InPlaceLeaseIntangibleAssetsMember2024-01-012024-06-300001674930flgt:LaboratoryServicesMemberflgt:InPlaceLeaseIntangibleAssetsMember2023-12-310001674930flgt:LongTermEquitySecuritiesMemberflgt:PreferredStockOfPrivatelyHeldCompanyMember2024-06-300001674930flgt:MedicalLabEquipmentMembersrt:MaximumMember2024-06-3000016749302022-12-310001674930us-gaap:SellingAndMarketingExpenseMember2024-04-012024-06-300001674930flgt:BiopharmaServicesMemberflgt:LaboratoryServicesMember2024-01-012024-06-300001674930us-gaap:NonUsMember2023-12-31xbrli:pureflgt:Customerxbrli:sharesiso4217:USDxbrli:sharesiso4217:USDflgt:Segment

 

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 June 30, 2024

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: 001-37894

 

FULGENT GENETICS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

81-2621304

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

4399 Santa Anita Avenue

El Monte, CA

91731

(Address of principal executive offices)

(Zip Code)

 

(626) 350-0537

(Registrant’s telephone number, including area code)

 

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

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

FLGT

 

The Nasdaq Stock Market
(Nasdaq Global 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, 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 Exchange Act). Yes ☐ No

As of July 30, 2024, there were 30,296,682 outstanding shares of the registrant’s common stock.

 

 


 

Table of Contents

 

 

Page

PART I—FINANCIAL INFORMATION

1

Item 1. Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations

2

Condensed Consolidated Statements of Comprehensive Income (Loss)

3

Condensed Consolidated Statements of Stockholders’ Equity

4

Condensed Consolidated Statements of Cash Flows

6

Notes to the Condensed Consolidated Financial Statements

7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

25

Item 3. Quantitative and Qualitative Disclosures About Market Risk

31

Item 4. Controls and Procedures

31

PART II—OTHER INFORMATION

33

Item 1. Legal Proceedings

33

Item 1A. Risk Factors

33

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

34

Item 5. Other Information

34

Item 6. Exhibits

34

Exhibit Index

35

Signatures

36

 

i


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

FULGENT GENETICS, INC.

Condensed Consolidated Balance Sheets

(in thousands, except par value data)

(unaudited)

 

 

June 30, 2024

 

 

December 31, 2023

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

65,111

 

 

$

97,473

 

Marketable securities

 

 

246,595

 

 

 

326,681

 

Trade accounts receivable, net of allowance for credit losses of $25,307 as of June 30, 2024, and $25,226 as of December 31, 2023

 

 

56,573

 

 

 

51,132

 

Other current assets

 

 

30,825

 

 

 

32,559

 

Total current assets

 

 

399,104

 

 

 

507,845

 

Marketable securities, long-term

 

 

526,163

 

 

 

423,571

 

Intangible assets, net

 

 

138,973

 

 

 

143,053

 

Fixed assets, net

 

 

93,368

 

 

 

83,464

 

Goodwill, net

 

 

22,055

 

 

 

22,055

 

Redeemable preferred stock investment

 

 

20,438

 

 

 

20,438

 

Other long-term assets

 

 

32,138

 

 

 

34,902

 

Total assets

 

$

1,232,239

 

 

$

1,235,328

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

19,873

 

 

$

15,360

 

Accrued liabilities

 

 

26,425

 

 

 

30,737

 

Customer deposit

 

 

26,297

 

 

 

22,700

 

Contract liabilities

 

 

2,744

 

 

 

2,874

 

Notes payable, current portion

 

 

412

 

 

 

1,183

 

Other current liabilities

 

 

 

 

 

164

 

Total current liabilities

 

 

75,751

 

 

 

73,018

 

Deferred tax liabilities

 

 

6,948

 

 

 

7,962

 

Unrecognized tax benefits

 

 

6,295

 

 

 

5,978

 

Other long-term liabilities

 

 

14,397

 

 

 

15,084

 

Total liabilities

 

 

103,391

 

 

 

102,042

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Common stock, $0.0001 par value per share, 50,000 shares authorized, 33,036 shares issued and 30,262 shares outstanding as of June 30, 2024, and 32,416 shares issued and 29,653 shares outstanding as of December 31, 2023

 

 

3

 

 

 

3

 

Preferred stock, $0.0001 par value per share, 1,000 shares authorized, no shares issued or outstanding, as of June 30, 2024, and December 31, 2023

 

 

 

 

 

 

Additional paid-in capital

 

 

522,420

 

 

 

501,718

 

Accumulated other comprehensive (loss) income

 

 

(877

)

 

 

1,205

 

Retained earnings

 

 

611,003

 

 

 

633,175

 

Total Fulgent stockholders’ equity

 

 

1,132,549

 

 

 

1,136,101

 

Noncontrolling interest

 

 

(3,701

)

 

 

(2,815

)

Total stockholders’ equity

 

 

1,128,848

 

 

 

1,133,286

 

Total liabilities and stockholders’ equity

 

$

1,232,239

 

 

$

1,235,328

 

 

 

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

1


 

FULGENT GENETICS, INC.

Condensed Consolidated Statements of Operations

(in thousands, except per share data)

(unaudited)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue

 

$

71,028

 

 

$

67,853

 

 

$

135,513

 

 

$

134,021

 

Cost of revenue

 

 

44,537

 

 

 

47,281

 

 

 

86,918

 

 

 

94,638

 

Gross profit

 

 

26,491

 

 

 

20,572

 

 

 

48,595

 

 

 

39,383

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

13,486

 

 

 

9,692

 

 

 

24,920

 

 

 

19,474

 

Selling and marketing

 

 

8,595

 

 

 

10,723

 

 

 

17,584

 

 

 

20,806

 

General and administrative

 

 

21,326

 

 

 

17,993

 

 

 

42,815

 

 

 

39,795

 

Amortization of intangible assets

 

 

1,990

 

 

 

1,962

 

 

 

3,980

 

 

 

3,930

 

Total operating expenses

 

 

45,397

 

 

 

40,370

 

 

 

89,299

 

 

 

84,005

 

Operating loss

 

 

(18,906

)

 

 

(19,798

)

 

 

(40,704

)

 

 

(44,622

)

Interest and other income, net

 

 

7,692

 

 

 

5,098

 

 

 

15,317

 

 

 

8,873

 

Loss before income taxes

 

 

(11,214

)

 

 

(14,700

)

 

 

(25,387

)

 

 

(35,749

)

Benefit from income taxes

 

 

(2,124

)

 

 

(3,110

)

 

 

(2,451

)

 

 

(8,310

)

Net loss from consolidated operations

 

 

(9,090

)

 

 

(11,590

)

 

 

(22,936

)

 

 

(27,439

)

Net loss attributable to noncontrolling interests

 

 

380

 

 

 

361

 

 

 

764

 

 

 

870

 

Net loss attributable to Fulgent

 

$

(8,710

)

 

$

(11,229

)

 

$

(22,172

)

 

$

(26,569

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per common share attributable to Fulgent

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.29

)

 

$

(0.38

)

 

$

(0.74

)

 

$

(0.90

)

Diluted

 

$

(0.29

)

 

$

(0.38

)

 

$

(0.74

)

 

$

(0.90

)

Weighted-average common shares:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

30,098

 

 

 

29,813

 

 

 

29,933

 

 

 

29,675

 

Diluted

 

 

30,098

 

 

 

29,813

 

 

 

29,933

 

 

 

29,675

 

 

 

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

 

2


 

FULGENT GENETICS, INC.

Condensed Consolidated Statements of Comprehensive Income (Loss)

(in thousands)

(unaudited)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net loss from consolidated operations

 

$

(9,090

)

 

$

(11,590

)

 

$

(22,936

)

 

$

(27,439

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation loss

 

 

(111

)

 

 

(1,965

)

 

 

(444

)

 

 

(1,797

)

Net gain (loss) on available-for-sale debt securities, net of tax

 

 

312

 

 

 

(2,132

)

 

 

(1,760

)

 

 

3,197

 

Comprehensive loss from consolidated operations

 

 

(8,889

)

 

 

(15,687

)

 

 

(25,140

)

 

 

(26,039

)

Net loss attributable to noncontrolling interest

 

 

380

 

 

 

361

 

 

 

764

 

 

 

870

 

Foreign currency translation loss (gain) attributable to noncontrolling interest

 

 

24

 

 

 

547

 

 

 

122

 

 

 

(1,243

)

Comprehensive loss (income) attributable to noncontrolling interest

 

 

404

 

 

 

908

 

 

 

886

 

 

 

(373

)

Comprehensive loss attributable to Fulgent

 

$

(8,485

)

 

$

(14,779

)

 

$

(24,254

)

 

$

(26,412

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

3


 

FULGENT GENETICS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands)

(unaudited)

 

 

Fulgent Stockholders’ Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares (1)

 

 

Amount

 

 

Additional
 Paid-In Capital

 

 

Accumulated
Other Comprehensive
Income (Loss)

 

 

Retained Earnings

 

 

Fulgent Stockholders’ Equity

 

 

Noncontrolling Interest

 

 

Total
Equity

 

Balance at December 31, 2023

 

 

29,653

 

 

$

3

 

 

$

501,718

 

 

$

1,205

 

 

$

633,175

 

 

$

1,136,101

 

 

$

(2,815

)

 

$

1,133,286

 

Equity-based compensation

 

 

 

 

 

 

 

 

11,518

 

 

 

 

 

 

 

 

 

11,518

 

 

 

 

 

 

11,518

 

Exercise of common stock options

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Restricted stock awards

 

 

315

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock withholding for employee tax obligations

 

 

(69

)

 

 

 

 

 

(1,682

)

 

 

 

 

 

 

 

 

(1,682

)

 

 

 

 

 

(1,682

)

Repurchase of common stock

 

 

(10

)

 

 

 

 

 

(225

)

 

 

 

 

 

 

 

 

(225

)

 

 

 

 

 

(225

)

Other comprehensive loss, net

 

 

 

 

 

 

 

 

 

 

 

(2,307

)

 

 

 

 

 

(2,307

)

 

 

(98

)

 

 

(2,405

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,462

)

 

 

(13,462

)

 

 

(384

)

 

 

(13,846

)

Balance at March 31, 2024

 

 

29,890

 

 

$

3

 

 

$

511,329

 

 

$

(1,102

)

 

$

619,713

 

 

$

1,129,943

 

 

$

(3,297

)

 

$

1,126,646

 

Equity-based compensation

 

 

 

 

 

 

 

 

11,635

 

 

 

 

 

 

 

 

 

11,635

 

 

 

 

 

 

11,635

 

Restricted stock awards

 

 

212

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock withholding for employee tax obligations

 

 

(26

)

 

 

 

 

 

(544

)

 

 

 

 

 

 

 

 

(544

)

 

 

 

 

 

(544

)

Repurchase of common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock issued in a business combination (1)

 

 

186

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss), net

 

 

 

 

 

 

 

 

 

 

 

225

 

 

 

 

 

 

225

 

 

 

(24

)

 

 

201

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,710

)

 

 

(8,710

)

 

 

(380

)

 

 

(9,090

)

Balance at June 30, 2024

 

 

30,262

 

 

$

3

 

 

$

522,420

 

 

$

(877

)

 

$

611,003

 

 

$

1,132,549

 

 

$

(3,701

)

 

$

1,128,848

 

(1) 185,503 shares of the Company's common stock were issued in May 2024 by the Company upon expiration of hold back provisions in connection with the business combination of Fulgent Pharma Holdings, Inc., or Fulgent Pharma, in 2022.

 

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

 

4


 

FULGENT GENETICS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands)

(unaudited)

 

 

 

Fulgent Stockholders’ Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares (1)

 

 

Amount

 

 

Additional
 Paid-In Capital

 

 

Accumulated
Other Comprehensive
Income (Loss)

 

 

Retained Earnings

 

 

Fulgent Stockholders’ Equity

 

 

Noncontrolling Interest

 

 

Total
Equity

 

Balance at December 31, 2022

 

 

29,438

 

 

$

3

 

 

$

486,585

 

 

$

(20,903

)

 

$

801,000

 

 

$

1,266,685

 

 

$

3,190

 

 

$

1,269,875

 

Equity-based compensation

 

 

 

 

 

 

 

 

10,265

 

 

 

 

 

 

 

 

 

10,265

 

 

 

 

 

 

10,265

 

Restricted stock awards

 

 

280

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock withholding for employee tax obligations

 

 

(26

)

 

 

 

 

 

(869

)

 

 

 

 

 

 

 

 

(869

)

 

 

 

 

 

(869

)

Other comprehensive income, net

 

 

 

 

 

 

 

 

 

 

 

3,707

 

 

 

 

 

 

3,707

 

 

 

1,790

 

 

 

5,497

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,340

)

 

 

(15,340

)

 

 

(509

)

 

 

(15,849

)

Balance at March 31, 2023

 

 

29,692

 

 

$

3

 

 

$

495,981

 

 

$

(17,196

)

 

$

785,660

 

 

$

1,264,448

 

 

$

4,471

 

 

$

1,268,919

 

Equity-based compensation

 

 

 

 

 

 

 

 

10,323

 

 

 

 

 

 

 

 

 

10,323

 

 

 

 

 

 

10,323

 

Exercise of common stock options

 

 

8

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Restricted stock awards

 

 

225

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock withholding for employee tax obligations

 

 

(8

)

 

 

 

 

 

(232

)

 

 

 

 

 

 

 

 

(232

)

 

 

 

 

 

(232

)

Other comprehensive loss, net

 

 

 

 

 

 

 

 

 

 

 

(3,550

)

 

 

 

 

 

(3,550

)

 

 

(547

)

 

 

(4,097

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,229

)

 

 

(11,229

)

 

 

(361

)

 

 

(11,590

)

Balance at June 30, 2023

 

 

29,917

 

 

$

3

 

 

$

506,075

 

 

$

(20,746

)

 

$

774,431

 

 

$

1,259,763

 

 

$

3,563

 

 

$

1,263,326

 

(1) As of June 30, 2023, 371,006 shares of the Company's common stock were not issued and were held back by the Company as partial security for the indemnification obligations in connection with the business combination of Fulgent Pharma, in 2022. 185,503 shares of the Company’s common stock were issued upon expiration of these hold back provisions in November 2023, and 185,503 shares were issued upon expiration of these hold back provisions in May 2024.

 

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

5


 

FULGENT GENETICS, INC.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

 

 

Six Months Ended June 30,

 

 

2024

 

 

2023

 

Cash flow from operating activities:

 

 

 

 

 

 

Net loss from consolidated operations

 

$

(22,936

)

 

$

(27,439

)

Adjustments to reconcile net loss to net cash provided by operating activities:

 

 

 

 

 

 

Equity-based compensation

 

 

23,153

 

 

 

20,588

 

Depreciation and amortization

 

 

12,816

 

 

 

13,191

 

Adjustment for credit losses

 

 

(4,157

)

 

 

(1,984

)

Noncash lease expense

 

 

2,679

 

 

 

3,268

 

Loss on disposal of fixed asset

 

 

172

 

 

 

11

 

Amortization of discount of marketable securities

 

 

(2,670

)

 

 

(1,192

)

Deferred taxes

 

 

(1,014

)

 

 

(8,418

)

Unrecognized tax benefits

 

 

317

 

 

 

 

Net realized loss on marketable securities

 

 

871

 

 

 

 

Other

 

 

(5

)

 

 

20

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Trade accounts receivable

 

 

(1,393

)

 

 

19,658

 

Other current and long-term assets

 

 

4,097

 

 

 

(3,764

)

Accounts payable

 

 

1,596

 

 

 

(4,447

)

Contract liabilities

 

 

(130

)

 

 

(598

)

Customer deposits

 

 

3,604

 

 

 

3,599

 

Accrued liabilities and other liabilities

 

 

(2,762

)

 

 

(7,519

)

Operating lease liabilities

 

 

(2,687

)

 

 

(3,144

)

Net cash provided by operating activities

 

 

11,551

 

 

 

1,830

 

Cash flow from investing activities:

 

 

 

 

 

 

Purchase of marketable securities

 

 

(258,829

)

 

 

(250,537

)

Purchases of fixed assets

 

 

(17,000

)

 

 

(14,178

)

Maturities of marketable securities

 

 

160,073

 

 

 

258,847

 

Proceeds from sale of marketable securities

 

 

75,599

 

 

 

 

Proceeds from sale of fixed assets

 

 

275

 

 

 

418

 

Net cash used in investing activities

 

 

(39,882

)

 

 

(5,450

)

Cash flow from financing activities:

 

 

 

 

 

 

Common stock withholding for employee tax obligations

 

 

(2,226

)

 

 

(1,101

)

Repayment of notes payable

 

 

(1,229

)

 

 

(799

)

Principal paid for finance lease

 

 

(273

)

 

 

(463

)

Repurchase of common stock

 

 

(225

)

 

 

 

Repayment of investment margin loan

 

 

 

 

 

(15,000

)

Proceeds from exercise of stock options

 

 

 

 

 

3

 

Net cash used in financing activities

 

 

(3,953

)

 

 

(17,360

)

Effect of exchange rate changes on cash and cash equivalents

 

 

(78

)

 

 

(178

)

Net decrease in cash and cash equivalents

 

 

(32,362

)

 

 

(21,158

)

Cash and cash equivalents at beginning of period

 

 

97,473

 

 

 

79,506

 

Cash and cash equivalents at end of period

 

$

65,111

 

 

$

58,348

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

Income taxes paid

 

$

1,903

 

 

$

2,636

 

Interest Paid

 

$

452

 

 

$

919

 

Supplemental disclosures of non-cash investing and financing activities:

 

 

 

 

 

 

Purchases of fixed assets in accounts payable

 

$

4,783

 

 

$

3,725

 

Operating lease right-of-use assets obtained in exchange for lease liabilities

 

$

1,146

 

 

$

2,661

 

Operating lease right-of-use assets reduced due to lease modification and termination

 

$

57

 

 

$

 

Finance lease right-of-use assets reduced due to lease modification and termination

 

$

 

 

$

696

 

 

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

6


 

FULGENT GENETICS, INC.

Notes to the Condensed Consolidated Financial Statements

(unaudited)

 

Note 1. Overview and Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. These financial statements include the assets, liabilities, revenues and expenses of all subsidiaries and entities in which the Company has a controlling financial interest or is deemed to be the primary beneficiary. In determining whether the Company is the primary beneficiary of an entity, the Company applies a qualitative approach that determines whether it has both (i) the power to direct the economically significant activities of the entity and (ii) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. The Company uses the equity method to account for its investments in entities that it does not control, but in which it has the ability to exercise significant influence over operating and financial policies. All intercompany accounts and transactions are eliminated from the accompanying condensed consolidated financial statements.

Nature of the Business

Fulgent Genetics, Inc., together with its subsidiaries and affiliated professional corporations, or PCs (collectively referred to as the Company, unless otherwise noted or the context otherwise requires), is a technology-based company with a well-established laboratory services business and a therapeutic development business. Its laboratory services business – to which the Company formerly referred as its clinical diagnostic business, includes technical laboratory services and professional interpretation of laboratory results by licensed physicians. Its therapeutic development business is focused on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs.

Unaudited Interim Financial Information

The accompanying unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s audited consolidated financial statements as of and for the fiscal year ended December 31, 2023, which are included in the Company’s annual report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 28, 2024, or the 2023 Annual Report, and, in the opinion of management, include all adjustments, which are normal and recurring in nature, necessary for a fair presentation of the Company’s financial position and results of operations. Operating results for interim periods are not necessarily indicative of the results that may be expected for a full fiscal year or any other period. The accompanying Condensed Consolidated Balance Sheet as of December 31, 2023 has been derived from the Company’s audited consolidated financial statements at that date but does not include all of the disclosures required by U.S. GAAP. As such, the information included in this quarterly report on Form 10-Q should be read in conjunction with the Company’s audited consolidated financial statements included in the 2023 Annual Report, including the notes thereto.

Note 2. Summary of Significant Accounting Policies

See the summary of the Company’s significant accounting policies set forth in the notes to its consolidated financial statements included in the 2023 Annual Report.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements, as well as the reported amounts of revenue and expenses during the reporting periods. These estimates, judgments and assumptions are based on historical data and experience available at the date of the accompanying condensed consolidated financial statements, as well as various other factors management believes to be reasonable under the circumstances. The Company’s estimates and assumptions may evolve as conditions change. Actual results could differ significantly from these estimates.

On an on-going basis, management evaluates its estimates, primarily those related to: (i) revenue recognition criteria, (ii) accounts receivable and allowances for credit losses, (iii) the useful lives of fixed assets and intangible assets, (iv) estimates of tax liabilities, (v) valuation of intangible assets and goodwill at time of acquisition and on a recurring basis, and (vi) valuation of investments.

7


 

Trade Accounts Receivable and Allowance for Credit Losses

Trade accounts receivable are stated at the amount the Company expects to collect. The Company maintains an allowance for credit losses for expected uncollectible trade accounts receivable, which is recorded as an offset to trade accounts receivable, and changes in allowance for credit losses are classified as a general and administrative expense in the accompanying Condensed Consolidated Statements of Operations. The Company assesses collectability by reviewing trade accounts receivable on a collective basis where similar risk characteristics exist and on an individual basis when it identifies specific customers that have deterioration in credit quality such that they may no longer share similar risk characteristics with the other receivables. In determining the amount of the allowance for credit losses, the Company uses a loss rate model or probability-of-default and loss given default model. Following the loss rate method, expected credit losses are determined based on an estimated historical loss rate. The probability of default method allows the ability to define a point of default and measure credit losses for receivables that have reached the point of default for purposes of calculating the allowance for credit losses. Loss given default represents the likelihood that a receivable that has reached the point of default will not be collected in full. The Company updates its credit loss rate and factors annually to incorporate the most recent historical data and adjusts the quantitative portion of the reserve through its qualitative reserve overlay. The Company looks at qualitative factors such as general economic conditions in determining expected credit losses.

The roll-forward for the allowance for credit losses for the six months ended June 30, 2024, dollars in thousands, is as follows:

 

Allowance for credit losses at beginning of year

$

25,226

 

Current period gain

 

(4,157

)

Write-downs

 

(2,855

)

Recoveries of amounts previously charged off

 

7,093

 

Allowance for credit losses as of June 30, 2024

$

25,307

 

Redeemable Preferred Stock Investment

The redeemable preferred stock investment of $20.4 million as of June 30, 2024 represents the fair value of redeemable preferred stock of a private company that the Company purchased in July 2021. The investment is classified as available-for-sale debt securities. The fair value of available-for-sale debt security is included in the Condensed Consolidated Balance Sheets. Since the Company intends on holding the preferred stock, and the preferred stock is not redeemable until July 2027, the investment is recorded as a long-term investment, and unrealized gain (loss) is excluded from earnings and reported in other comprehensive income (loss). The unrealized gain (loss) is insignificant in each of the three and six months ended June 30, 2024, and $(0.1) million and $0.5 million in the three and six months ended June 30, 2023, respectively.

Finite-Lived Intangible assets

Intangible assets, unless determined to be indefinite-lived, are amortized over their estimated useful lives. The Company amortizes intangible assets on a straight-line basis with definite lives generally over periods ranging from three to fourteen years. See Note 14, Goodwill and Acquisition-Related Intangibles, for details of intangible assets.

Impairment of Long-Lived Assets

The Company evaluates the carrying amount of its long-lived assets whenever events or changes in circumstances indicate that the assets may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of an asset and its eventual disposition is less than the carrying amount of the asset.

Goodwill and Indefinite-Lived Intangibles

Intangibles in-process research & development costs, or IPR&D, are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. If and when development is complete, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point in time.

The Company assesses goodwill and indefinite-lived intangibles for impairment on an annual basis and between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying amount. The Company may choose to bypass a qualitative assessment of impairment for any reporting unit and proceed directly to performing a quantitative assessment. An impairment loss would be recognized for the amount by which the reporting unit's carrying amount exceeds its fair value.

The Company’s quantitative assessment includes estimating the fair value of each reporting unit and comparing it to its carrying value. The Company estimates the fair value of reporting units using both income-based and market-based valuation methods and

8


 

typically engages a third-party appraisal firm to assist with the valuation. The estimated fair value for each reporting unit is determined based upon the range of estimated values developed from the income and market-based methods. If the estimated fair value of a reporting unit exceeds its carrying value, the goodwill is not impaired, and no further review is required.

The income-based fair value methodology is based on a reporting unit’s forecasted future cash flows that are discounted to the present value using the reporting unit’s weighted average cost of capital. Under the income-based approach, it requires management's assumptions and judgments regarding economic conditions in the markets in which the company operates and conditions in the capital markets, many of which are outside of management's control. The market-based fair value methodology looks at the guideline public company valuation method to determine the prices of comparable public companies and looks at merger and acquisition methods, similar businesses that were sold recently, to estimate the value of the reporting units. Under the market-based approach, judgment is required in evaluating market multiples and recent transactions.

Fair Value of Financial Instruments

The Company’s financial instruments consist principally of cash and cash equivalents, marketable securities, trade accounts receivable, redeemable preferred stock investment, accounts payable, and accrued liabilities. The carrying amounts of certain of these financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and accrued liabilities approximate fair value due to their short maturities. Fair value of marketable securities and redeemable preferred stock investment is disclosed in Note 4, Fair Value Measurements, to the accompanying consolidated financial statements.

Concentrations of Credit Risk, Customers, and Suppliers

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents, trade accounts receivable, and marketable securities, which consist of debt securities and equity securities. As of June 30, 2024, substantially all of the Company’s cash and cash equivalents were deposited in accounts at financial institutions, and amounts may exceed federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial strength of the depository institutions in which its cash and cash equivalents are held.

In certain periods, a small number of customers has accounted for a significant portion of the Company’s revenue. For the laboratory services business, aggregating customers under common control, one customer comprised of $16.9 million or 24% of total revenue in the three months ended June 30, 2024 and $29.6 million or 22% of the Company's revenue in the six months ended June 30, 2024. The same customer contributed $9.1 million or 13% of the Company's revenue in the three months ended June 30, 2023. No customer contributed more than 10% of the Company's revenue in the six months ended June 30, 2023. One customer comprised 19% of total accounts receivable, net, as of June 30, 2024, and 13% of total accounts receivable, net, as of December 31, 2023. For the therapeutic development business, as of June 30, 2024 and December 31, 2023, there is no concentration risk, as there are no customers or revenue, as it does not have any commercialized or approved product candidates.

The Company relies on a limited number of suppliers for certain laboratory substances used in the chemical reactions incorporated into its processes, referred to as reagents, as well as for the sequencers and various other equipment and materials it uses in its laboratory operations. In particular, the Company relies on a sole supplier for the next generation sequencers and associated reagents it uses to perform its genetic tests and as the sole provider of maintenance and repair services for these sequencers. The operations of the laboratory services business would be interrupted if it encountered delays or difficulties securing these reagents, sequencers, other equipment or materials or maintenance and repair services, which could occur for a variety of reasons, including if the Company needs a replacement or temporary substitute for any of its limited or sole suppliers and is not able to locate and make arrangements with an acceptable replacement or temporary substitute. The Company's development efforts could also be delayed or interrupted if is unable to procure items needed for its therapeutic development activities. The Company’s therapeutic development business also relies on ANP Technologies, Inc., or ANP, for certain laboratory services, equipment, tools, and drug intermediates in connection with research and development efforts. The Company believes there are currently only a few other manufacturers that are capable of supplying and servicing some of the equipment and other materials necessary for its laboratory operations, including collection kits, sequencers and various associated reagents.

Equity Method Investments

The Company uses the equity method to account for investments in entities that it does not control but in which it has the ability to exercise significant influence over operating and financial policies. The Company's 25% interest in Boston Molecules, Inc. is accounted for using the equity method but the investment was reduced to zero in 2020 due to full impairment. The Company has not recorded any additional losses.

9


 

Reportable Segment and Geographic Information

Reportable segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker, or CODM, in making decisions regarding resource allocation and assessing performance. The Company’s CODM is its Chief Executive Officer. The Company reports its business in two segments, a laboratory services business and a therapeutic development business. For further financial information about these segments, including information for each of the periods presented regarding revenue, operating income (loss), and other important information, see Note 7, Reportable Segment and Geographic Information.

Foreign Currency Translation and Foreign Currency Transactions

The Company translates the assets and liabilities of its non-U.S. dollar functional currency subsidiaries into U.S. dollars using exchange rates in effect at the end of each period. Expenses for these subsidiaries are translated using rates that approximate those in effect during the period. Loss from these translations is recognized in foreign currency translation loss included in the accompanying Condensed Consolidated Statements of Comprehensive Income (Loss).

The Company and its subsidiaries that use the U.S. dollar as their functional currency remeasure monetary assets and liabilities at exchange rates in effect at the end of each period, whereas reagents and supplies, property and nonmonetary assets and liabilities are measured at historical rates. Gain or loss from these remeasurements was not significant for the three and six months ended June 30, 2024 and 2023.

Comprehensive Income (Loss)

Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) consists of net unrealized gain (loss) on available-for-sale debt securities, net of tax, and foreign currency translation adjustments from the Company's subsidiaries not using the U.S. dollar as their functional currency. Reclassification from other comprehensive income (loss) to net loss was $0.3 million and $0.9 million in the three and six months ended June 30, 2024, respectively, and there were no reclassifications from other comprehensive income (loss) to net loss in the three and six months ended June 30, 2023. The tax effect related to net unrealized losses on available-for-sale debt securities was zero in the three and six months ended June 30, 2024 due to the valuation allowance in the current period that precludes the Company from recognizing the deferred tax benefit. The tax effects related to net unrealized gain (loss) on available-for-sale debt securities were $(0.8) million and $1.2 million in the three and six months ended June 30, 2023, respectively.

Disaggregation of Revenue

The Company classifies its customers into three payor types: (i) Insurance, (ii) Institutions, including hospitals, medical institutions, other laboratories, governmental bodies, municipalities, and large corporations, or (iii) Patients who pay directly. The Company believes these classifications best depict how the nature, amount, timing, and uncertainty of its revenue and cash flows are affected by economic factors. The following table summarizes revenue from contracts with customers by payor type:

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Revenue by payor

 

 

 

 

 

 

 

 

 

 

 

 

Institutional

 

$

38,950

 

 

$

34,082

 

 

$

72,554

 

 

$

65,074

 

Insurance

 

 

31,100

 

 

 

33,061

 

 

 

61,143

 

 

 

67,612

 

Patient

 

 

978

 

 

 

710

 

 

 

1,816

 

 

 

1,335

 

Total revenue

 

$

71,028

 

 

$

67,853

 

 

$

135,513

 

 

$

134,021

 

During three and six months ended June 30, 2024, the Company experienced a change in estimate related to variable consideration. $0.6 million and $1.8 million variable consideration were recognized in the three and six months ended June 30, 2024, respectively, that related to COVID-19 tests completed in the prior periods due to the recent collection efforts, which was included as revenue from insurance in the table above. The Company estimates variable consideration using the expected value method. Any changes in variable consideration estimates that affect transactions are accounted for on a cumulative catch-up basis. There was no material variable consideration recognized in the three and six months ended June 30, 2023.

10


 

Contract Balances

Receivables from contracts with customers - Receivables from contracts with customers are included within trade accounts receivable on the Condensed Consolidated Balance Sheets. Net receivable from Insurance and Institutional customers represented 44% and 56%, respectively, as of June 30, 2024, and 39% and 61%, respectively, as of December 31, 2023.

Contracts assets and liabilities - Contract assets from contracts with customers associated with contract execution and certain costs to fulfill a contract are included in other current assets in the accompanying Condensed Consolidated Balance Sheets. The Company did not have any contract assets as of June 30, 2024 and December 31, 2023. Contract liabilities are recorded when the Company receives payment prior to completing its obligation to transfer goods or services to a customer. Contract liabilities are included in the current liabilities in Condensed Consolidated Balance Sheets. Revenues of $0.4 million and $1.2 million were recognized for the three and six months ended June 30, 2024, respectively, and $0.1 million and $1.7 million were recognized for the three and six months ended June 30, 2023, respectively, related to contract liabilities at the beginning of the respective periods.

Recent Accounting Pronouncements

The Company evaluates all Accounting Standards Updates, or ASUs, issued by the Financial Accounting Standards Board, or FASB, for consideration of their applicability. ASUs not included in the Company’s disclosures were assessed and determined to be either not applicable or are not expected to have a material impact on the Company’s condensed consolidated financial statements.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segments. This update improves reportable segment disclosure requirements and requires enhanced disclosures related to significant segment expenses regularly provided to the CODM, the amount for other segment items with descriptions of the composition, segment profit or loss, and clarification on if the CODM uses more than one measurement of a segment's profit or loss in assessing segment performance and deciding how to allocate resources. Amendments in this update are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating the impacts of this amendment on the consolidated financial statements and related disclosure.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvement to Income Tax Disclosures. The update requires more detailed information on certain income tax disclosures including the income tax rate reconciliation and income taxes paid. Amendments in this update are effective for annual periods beginning December 15, 2024 for public entities, and early adoption is permitted. The Company is currently evaluating the impacts of this amendment on the consolidated financial statements and related disclosure.

The Company does not expect that any other recently issued accounting guidance will have a significant effect on its consolidated financial statements.

11


 

Note 3. Equity and Debt Securities

The Company’s equity and debt securities consisted of the following:

 

 

June 30, 2024

 

 

Amortized
Cost Basis

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Aggregate
Fair Value

 

 

(in thousands)

 

Equity securities:

 

 

 

 

 

 

 

 

 

 

 

Long-term

 

 

 

 

 

 

 

 

 

 

 

Preferred stock of privately held company

$

15,000

 

 

$

 

 

$

 

 

$

15,000

 

Total equity securities

 

15,000

 

 

 

 

 

 

 

 

 

15,000

 

Available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

Short-term

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

 

98,931

 

 

 

2

 

 

 

(588

)

 

 

98,345

 

U.S. agency debt securities

 

77,972

 

 

 

 

 

 

(674

)

 

 

77,298

 

U.S. treasury bills

 

51,651

 

 

 

 

 

 

(5

)

 

 

51,646

 

Corporate debt securities

 

13,325

 

 

 

 

 

 

(188

)

 

 

13,137

 

Money market accounts

 

55,067

 

 

 

 

 

 

 

 

 

55,067

 

Municipal bonds

 

6,189

 

 

 

 

 

 

(20

)

 

 

6,169

 

Less: Cash equivalents

 

(55,067

)

 

 

 

 

 

 

 

 

(55,067

)

Total debt securities due within 1 year

 

248,068

 

 

 

2

 

 

 

(1,475

)

 

 

246,595

 

After 1 year through 5 years

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

 

348,055

 

 

 

147

 

 

 

(2,784

)

 

 

345,418

 

U.S. agency debt securities

 

142,196

 

 

 

 

 

 

(1,511

)

 

 

140,685

 

Corporate debt securities

 

36,518

 

 

 

 

 

 

(560

)

 

 

35,958

 

Municipal bonds

 

2,888

 

 

 

2

 

 

 

(14

)

 

 

2,876

 

Yankee debt securities

 

501

 

 

 

 

 

 

(37

)

 

 

464

 

Redeemable preferred stock investment

 

20,000

 

 

 

438

 

 

 

 

 

 

20,438

 

Total debt securities due after 1 year through 5 years

 

550,158

 

 

 

587

 

 

 

(4,906

)

 

 

545,839

 

After 5 years through 10 years

 

 

 

 

 

 

 

 

 

 

 

Municipal bonds

 

765

 

 

 

1

 

 

 

(4

)

 

 

762

 

Total debt securities due after 5 years through 10 years

 

765

 

 

 

1

 

 

 

(4

)

 

 

762

 

Total available-for-sale debt securities

 

798,991

 

 

 

590

 

 

 

(6,385

)

 

 

793,196

 

Total equity and debt securities

$

813,991

 

 

$

590

 

 

$

(6,385

)

 

$

808,196

 

 

12


 

 

 

December 31, 2023

 

 

Amortized
Cost Basis

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Aggregate
Fair Value

 

 

(in thousands)

 

Equity securities:

 

 

 

 

 

 

 

 

 

 

 

Long-term

 

 

 

 

 

 

 

 

 

 

 

Preferred stock of privately held company

$

15,000

 

 

$

 

 

$

 

 

$

15,000

 

Total equity securities

 

15,000

 

 

 

 

 

 

 

 

 

15,000

 

Available-for-sale debt securities

 

 

 

 

 

 

 

 

 

 

 

Short-term

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

 

119,739

 

 

 

8

 

 

 

(1,765

)

 

 

117,982

 

U.S. agency debt securities

 

72,310

 

 

 

 

 

 

(1,414

)

 

 

70,896

 

U.S. treasury bills

 

69,214

 

 

 

36

 

 

 

 

 

 

69,250

 

Corporate debt securities

 

63,810

 

 

 

 

 

 

(792

)

 

 

63,018

 

Money market accounts

 

38,291

 

 

 

 

 

 

 

 

 

38,291

 

Municipal bonds

 

5,557

 

 

 

1

 

 

 

(23

)

 

 

5,535

 

Less: Cash equivalents

 

(38,291

)

 

 

 

 

 

 

 

 

(38,291

)

Total debt securities due within 1 year

 

330,630

 

 

 

45

 

 

 

(3,994

)

 

 

326,681

 

After 1 year through 5 years

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

 

247,104

 

 

 

1,262

 

 

 

(578

)

 

 

247,788

 

U.S. agency debt securities

 

156,150

 

 

 

161

 

 

 

(490

)

 

 

155,821

 

Corporate debt securities

 

12,885

 

 

 

 

 

 

(765

)

 

 

12,120

 

Municipal bonds

 

6,337

 

 

 

2

 

 

 

(48

)

 

 

6,291

 

Yankee debt securities

 

752

 

 

 

 

 

 

(60

)

 

 

692

 

Redeemable preferred stock investment

 

20,000

 

 

 

438

 

 

 

 

 

 

20,438

 

Total debt securities due after 1 year through 5 years

 

443,228

 

 

 

1,863

 

 

 

(1,941

)

 

 

443,150

 

After 5 years through 10 years

 

 

 

 

 

 

 

 

 

 

 

Municipal bonds

 

868

 

 

 

1

 

 

 

(10

)

 

 

859

 

Total debt securities due after 5 years through 10 years

 

868

 

 

 

1

 

 

 

(10

)

 

 

859

 

Total available-for-sale debt securities

 

774,726

 

 

 

1,909

 

 

 

(5,945

)

 

 

770,690

 

Total equity and debt securities

$

789,726

 

 

$

1,909

 

 

$

(5,945

)

 

$

785,690

 

Gross unrealized losses on the Company’s equity and debt securities were $6.4 million and $5.9 million as of June 30, 2024 and December 31, 2023, respectively. Proceeds from sale of available-for-sale securities were $18.7 million and $75.6 million for the three and six months ended June 30, 2024, respectively. Gross realized losses on the Company's available-for-sale securities were $0.3 million and $0.9 million for the three and six months ended June 30, 2024, respectively, and the gross realized income was insignificant for the three and six months ended June 30, 2024. There was no sale of available-for-sale securities or realized gain or loss for each of the three and six months ended June 30, 2023. The cost of any marketable securities sold is based on the specific-identification method. The Company did not recognize any credit losses for its available-for-sale debt securities during each of the three and six months ended June 30, 2024 and 2023.

Note 4. Fair Value Measurements

The authoritative guidance on fair value measurements establishes a framework with respect to measuring assets and liabilities at fair value on a recurring basis and non-recurring basis. Under the framework, fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as of the measurement date. The framework also establishes a three-tier hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability and are developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability and are developed based on the best information available in the circumstances. The hierarchy consists of the following three levels:

Level 1:

Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date.

13


 

Level 2:

Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.

Level 3:

Inputs are unobservable for the asset or liability.

 

The following tables present information about the Company’s financial assets measured at fair value on a recurring basis, based on the above three-tier fair value hierarchy:

 

 

June 30, 2024

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

(in thousands)

 

Equity securities, debt securities and cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

$

443,763

 

 

$

 

 

$

443,763

 

 

$

 

U.S. agency debt securities

 

217,983

 

 

 

 

 

 

217,983

 

 

 

 

Money market accounts

 

55,067

 

 

 

55,067

 

 

 

 

 

 

 

U.S. treasury bills

 

51,646

 

 

 

51,646

 

 

 

 

 

 

 

Corporate debt securities

 

49,095

 

 

 

 

 

 

49,095

 

 

 

 

Redeemable preferred stock investment

 

20,438

 

 

 

 

 

 

 

 

 

20,438

 

Preferred stock of privately held company

 

15,000

 

 

 

 

 

 

 

 

 

15,000

 

Municipal bonds

 

9,807

 

 

 

 

 

 

9,807

 

 

 

 

Yankee debt securities

 

464

 

 

 

 

 

 

464

 

 

 

 

Total equity securities, debt securities and cash equivalents

$

863,263

 

 

$

106,713

 

 

$

721,112

 

 

$

35,438

 

 

 

December 31, 2023

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

(in thousands)

 

Equity securities, debt securities and cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

U.S. government debt securities

$

365,770

 

 

$

 

 

$

365,770

 

 

$

 

U.S. agency debt securities

 

226,717

 

 

 

 

 

 

226,717

 

 

 

 

Corporate debt securities

 

75,138

 

 

 

 

 

 

75,138

 

 

 

 

U.S. treasury bills

 

69,250

 

 

 

69,250

 

 

 

 

 

 

 

Money market accounts

 

38,291

 

 

 

38,291

 

 

 

 

 

 

 

Redeemable preferred stock investment

 

20,438

 

 

 

 

 

 

 

 

 

20,438

 

Preferred stock of privately held company

 

15,000

 

 

 

 

 

 

 

 

 

15,000

 

Municipal bonds

 

12,685

 

 

 

 

 

 

12,685

 

 

 

 

Yankee debt securities

 

692

 

 

 

 

 

 

692

 

 

 

 

Total equity securities, debt securities and cash equivalents

$

823,981

 

 

$

107,541

 

 

$

681,002

 

 

$

35,438

 

The Company’s Level 1 assets include U.S. treasury bills and money market instruments and are valued based upon observable market prices. Level 2 assets consist of U.S. government and U.S. agency debt securities, municipal bonds, corporate debt securities and Yankee debt securities. Level 2 securities are valued based upon observable inputs that include reported trades, broker/dealer quotes, bids and offers. As of June 30, 2024, the Company had preferred stock of a privately held company, which was included in other long-term assets in the accompanying Condensed Consolidated Balance Sheets, and redeemable preferred stock of a private company that were measured using unobservable (Level 3) inputs. The fair value of redeemable preferred stock as of June 30, 2024 and December 31, 2023 was based on valuation performed by a third-party valuation company utilizing the guideline public company method under market approach and the discounted cash flow method under income approach. For the value of the investment in private equity securities, the Company elected to measure it at cost minus impairment, as the preferred stock of the privately held company did not have a readily determinable fair value, and no impairment loss was recorded as of June 30, 2024.

There were no transfers between fair value measurement levels during the three and six months ended June 30, 2024 and 2023.

14


 

Note 5. Fixed Assets

Major classes of fixed assets consisted of the following:

 

 

Useful Lives

June 30, 2024

 

 

December 31, 2023

 

 

 

(in thousands)

 

Medical lab equipment

5 months to 12 Years

$

54,152

 

 

$

56,025

 

Building improvements

6 months to 39 Years

 

16,383

 

 

 

7,748

 

Building

39 Years

 

15,923

 

 

 

9,781

 

Computer software

1 to 5 Years

 

8,039

 

 

 

7,982

 

Computer hardware

1 to 5 Years

 

6,882

 

 

 

6,805

 

Aircraft

7 Years

 

6,400

 

 

 

6,400

 

Leasehold improvements

Shorter of lease term or estimated useful life

 

5,556

 

 

 

11,222

 

Furniture and fixtures

1 to 5 Years

 

3,491

 

 

 

3,860

 

Land improvements

5 to 15 Years

 

904

 

 

 

904

 

Automobile

3 to 7 Years

 

450

 

 

 

445

 

General equipment

3 to 5 Years

 

108

 

 

 

115

 

Land

 

 

12,675

 

 

 

8,800

 

Assets not yet placed in service

 

 

7,842

 

 

 

15,010

 

Total

 

 

138,805

 

 

 

135,097

 

Less: Accumulated depreciation

 

 

(45,437

)

 

 

(51,633

)

Fixed assets, net

 

$

93,368

 

 

$

83,464

 

Depreciation expenses on fixed assets totaled $4.0 million and $8.6 million for the three and six months ended June 30, 2024, respectively, and $4.1 million and $8.8 million for the three and six months ended June 30, 2023, respectively.

Note 6. Other Significant Balance Sheet Accounts

Other current assets consisted of the following:

 

 

June 30, 2024

 

 

December 31, 2023

 

 

 

(in thousands)

 

Prepaid income taxes

 

$

9,363

 

 

$

12,675

 

Prepaid expenses

 

 

7,294

 

 

 

7,744

 

Reagents and supplies

 

 

7,026

 

 

 

5,827

 

Marketable securities interest receivable

 

 

5,917

 

 

 

4,994

 

Other receivable

 

 

1,225

 

 

 

1,319

 

Total

 

$

30,825

 

 

$

32,559

 

Accrued liabilities consisted of the following:

 

 

June 30, 2024

 

 

December 31, 2023

 

 

 

(in thousands)

 

Accrued legal liabilities

 

$

7,026

 

 

$

7,026

 

Payroll liabilities

 

 

6,024

 

 

 

5,741

 

Vacation accrual

 

 

4,134

 

 

 

3,543

 

Other accrued liabilities

 

 

3,738

 

 

 

4,215

 

Accrued bonus and commission

 

 

3,215

 

 

 

6,255

 

Operating lease liabilities - short term

 

 

2,288

 

 

 

3,957

 

Total

 

$

26,425

 

 

$

30,737

 

 

15


 

Accrued legal liabilities as of June 30, 2024, and December 31, 2023, included $6.9 million in connection with the Company's voluntary disclosure process as described in Note 8, Debt, Commitments, and Contingencies. Other accrued liabilities included short-term finance lease liabilities, health insurance liabilities, and third-party billing services.

Other long-term liabilities consisted of the following:

 

 

 

June 30, 2024

 

 

December 31, 2023

 

 

 

(in thousands)

 

Operating lease liabilities, long term

 

$

7,155

 

 

$

7,147

 

Other long-term liabilities

 

 

4,749

 

 

 

4,973

 

Notes payable, long term

 

 

2,493

 

 

 

2,964

 

Total

 

$

14,397

 

 

$

15,084

 

 

Note 7. Reportable Segment and Geographic Information

The Company viewed and managed its operations in one reportable segment prior to December 2023. Given the advancement of the therapeutic development business, the Company made certain changes, including the bifurcation of financial information for the Company’s budget and forecast planning process in December 2023. The CODM manages the operations of the Company and reviews discrete financial information to make resource decisions for its two operating segments separately. These are laboratory services and therapeutic development. The laboratory services operating segment offers technical laboratory services and professional interpretation of laboratory results by licensed physicians who specialize in pathology and oncology. The therapeutic development operating segment is a pharmaceutical research and development entity that the Company acquired in November 2022. These operating segments do not meet the aggregation criteria and therefore represent the Company’s reportable segments.

There is no inter-segment allocation of interest expense and income taxes. There is no inter-segment revenue and operating income or loss. Information regarding the Company’s operations and assets for its reportable segments as well as geographic information are as follows:

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

(in thousands)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Laboratory services:

 

 

 

 

 

 

 

 

 

 

 

Precision diagnostics

$

43,144

 

 

$

31,935

 

 

$

80,590

 

 

$

59,840

 

Anatomic pathology

 

23,431

 

 

 

27,390

 

 

 

46,538

 

 

 

53,801

 

BioPharma services

 

3,612

 

 

 

7,771

 

 

 

6,268

 

 

 

16,191

 

COVID-19

 

841

 

 

 

757

 

 

 

2,117

 

 

 

4,189

 

Total laboratory services

 

71,028

 

 

 

67,853

 

 

 

135,513

 

 

 

134,021

 

Therapeutic development

 

 

 

 

 

 

 

 

 

 

 

Total

$

71,028

 

 

$

67,853

 

 

$

135,513

 

 

$

134,021

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

(in thousands)

 

Loss before income taxes:

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

 

 

 

 

 

 

 

 

 

Laboratory services

$

(11,823

)

 

$

(16,282

)

 

$

(28,577

)

 

$

(37,885

)

Therapeutic development

 

(7,083

)

 

 

(3,516

)

 

 

(12,127

)

 

 

(6,737

)

Total operating loss

 

(18,906

)

 

 

(19,798

)

 

 

(40,704

)

 

 

(44,622

)

Interest and other income, net

 

7,692

 

 

 

5,098

 

 

 

15,317

 

 

 

8,873

 

Loss before income taxes

$

(11,214

)

 

$

(14,700

)

 

$

(25,387

)

 

$

(35,749

)

 

16


 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

(in thousands)

 

Depreciation and amortization:

 

 

 

 

 

 

 

 

 

 

 

Laboratory services

$

5,979

 

 

$

6,146

 

 

$

12,468

 

 

$

12,866

 

Therapeutic development

 

174

 

 

 

166

 

 

 

348

 

 

 

325

 

Total

$

6,153

 

 

$

6,312

 

 

$

12,816

 

 

$

13,191

 

 

 

June 30, 2024

 

 

December 31, 2023

 

 

(in thousands)

 

Assets:

 

 

 

 

 

Laboratory services

$

1,143,531

 

 

$

1,146,192

 

Therapeutic development

 

88,708

 

 

 

89,136

 

Total

$

1,232,239

 

 

$

1,235,328

 

 

Geographic distribution of revenue:

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

(in thousands)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

United States

$

64,194

 

 

$

63,051

 

 

$

122,044

 

 

$

125,113

 

Foreign

 

 

 

 

 

 

 

 

 

 

 

China

 

2,477

 

 

 

2,694

 

 

 

6,581

 

 

 

4,782

 

Other countries

 

4,357

 

 

 

2,108

 

 

 

6,888

 

 

 

4,126

 

Total foreign

 

6,834

 

 

 

4,802

 

 

 

13,469

 

 

 

8,908

 

Total

$

71,028

 

 

$

67,853

 

 

$

135,513

 

 

$

134,021

 

 

Geographic distribution of property, plant and equipment, net:

 

 

June 30, 2024

 

 

December 31, 2023

 

 

(in thousands)

 

Fixed assets:

 

 

 

 

 

United States

$

88,715

 

 

$

77,938

 

Foreign

 

4,653

 

 

 

5,526

 

Total

$

93,368

 

 

$

83,464

 

 

Note 8. Debt, Commitments, and Contingencies

Debt

Notes payable as of June 30, 2024 consisted of $2.9 million of notes payable related to an installment sale contract the Company entered in February 2022 for a building. The notes payable related to the installment sale are due in February 2030, and carry an interest rate of 1.08%. The current portion and noncurrent portion are $0.4 million and $2.5 million, respectively, and the noncurrent portion is included in the other long-term liabilities in the accompanying Condensed Consolidated Balance Sheets. The related interest expenses for the three and six months ended June 30, 2024 and 2023 were not significant.

Purchase Obligations

From time to time, the Company enters into certain purchase commitments with its vendors, consisting primarily of services, reagent and supplies, computer software, and medical lab equipment. As of June 30, 2024, the Company had non-cancelable purchase obligations of $45.7 million, of which $32.1 million is payable within twelve months, and the remainder, $13.6 million is payable within the next five years.

Contingencies

17


 

From time to time, the Company may be subject to legal proceedings and claims arising in the ordinary course of business.

As previously disclosed in the Company’s periodic reports filed pursuant to the Securities Exchange Act of 1934, as amended, or the Exchange Act, the Company has received a Civil Investigative Demand, or CID, issued by the U.S. Department of Justice, or the DOJ, pursuant to the False Claims Act related to its investigation of allegations of medically unnecessary laboratory testing, improper billing for laboratory testing, and remuneration received or provided in violation of the Anti-Kickback Statute and the Stark Law. Among other things, this CID requests information and records relating to certain of the Company’s customers named in the CID. Also, as previously disclosed, the SEC is conducting a non-public formal investigation, which appears to relate to the matters raised in the CID requests and the Company’s Exchange Act reports filed for 2018 through 2020. The Company is fully cooperating with both the U.S. DOJ and the SEC in connection with their requests and investigations. On May 6, 2024, the SEC staff, or the Staff, advised the Company that it has made a preliminary determination to recommend that the SEC file an enforcement action against the Company based on a corporate negligence theory, which, if authorized, would allege violations of Sections 17(a)(2) and 17(a)(3) of the Securities Act of 1933, as amended, Sections 13(a), 13(b)(2)(A) and 13(b)(2)(B) of the Exchange Act, and Rules 13a-1, 13a-13, and 12b-20 thereunder. The Company does not believe that any enforcement recommendation is warranted and, on June 7, 2024, responded to the Staff’s preliminary recommendation. The Company is engaged in ongoing discussions with the SEC staff and the DOJ regarding these matters. The Company cannot predict when these matters will be resolved, the outcome of these matters, or their potential impact, which may materially and adversely affect the Company’s business, prospects, and financial condition.

Similar to other laboratories in the industry, the Company is currently being audited by the U.S. Health Resources and Services Administration, or HRSA, with respect to its reimbursement for COVID-19 tests furnished to patients believed to be uninsured. The Company recorded approximately $548.9 million of reimbursements from HRSA under the Uninsured Program during the years ended December 31, 2022, 2021, and 2020. The Company is fully cooperating and working with HRSA’s auditors to resolve any issues, including any reimbursed amounts that may need to be returned to HRSA. There is uncertainty with respect to the methodology HRSA will use and whether and how they will extrapolate audit results. The results of the HRSA audit may materially and adversely affect the Company’s business, prospects, and financial condition.

The Company cannot reasonably estimate the loss or range of loss, if any, that may result from any material government investigations, audits, and reviews in which it is currently involved, given the inherent difficulty in predicting regulatory action, fines and penalties, if any, and the various remedies and levels of judicial review available to the Company in the event of an adverse finding. As a result, the Company has not recorded any liability related to these matters.

In relation to a recent advisory opinion issued by the Office of Inspector General of the Department of Health and Human Services, the Company’s subsidiary, Symphony Buyer, Inc., or Inform Diagnostics, initiated a voluntary disclosure process with the appropriate government contact. The Company currently has estimated and recorded $6.9 million as a liability in its financial statements in connection with this voluntary disclosure. This estimate may be incorrect, and the actual amount of liability may be lower or may materially exceed this estimate.

Note 9. Leases

Lessee

The Company is a lessee to various non-cancelable operating leases with varying terms through March 2034 primarily for laboratory and office space and equipment. The Company has options to renew some of these leases after their expirations. On a lease-by-lease basis, the Company considers such options, which may be elected at the Company’s sole discretion, in determining the lease term. The Company also has various finance leases for lab equipment with varying terms through December 2026, some of which were acquired in business combinations. The Company does not have any leases with variable lease payments. The Company’s operating lease agreements do not contain any residual value guarantees, material restrictive covenants, bargain purchase options, or asset retirement obligations.

The Company’s headquarters are located in El Monte, California, which is comprised of various corporate offices and a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, and licensed by the State of California Department of Public Health. Other CLIA-certified laboratories are located in Coppell, Texas; Needham, Massachusetts; Phoenix, Arizona; Alpharetta, Georgia; and New York, New York.

18


 

The operating and finance lease right-of-use asset, short-term lease liabilities, and long-term lease liabilities as of June 30, 2024 and December 31, 2023 were as follows:

 

 

June 30, 2024

 

 

December 31, 2023

 

 

(in thousands)

 

Operating lease ROU asset, net

$

9,186

 

 

$

10,838

 

Operating lease liabilities, short term

$

2,288

 

 

$

3,957

 

Operating lease liabilities, long term

$

7,155

 

 

$

7,147

 

Finance lease ROU asset, net

$

1,037

 

 

$

1,316

 

Finance lease liabilities, short term

$

492

 

 

$

544

 

Finance lease liabilities, long term

$

535

 

 

$

760

 

The following were operating and finance lease expenses:

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

(in thousands)

 

Operating lease cost

$

1,348

 

 

$

1,834

 

 

$

2,977

 

 

$

3,536

 

Finance lease cost:

 

 

 

 

 

 

 

 

 

 

 

Amortization of ROU assets

 

136

 

 

 

243

 

 

 

273

 

 

 

486

 

Interest on lease liabilities

 

11

 

 

 

25

 

 

 

23

 

 

 

52

 

Short-term lease cost

 

322

 

 

 

506

 

 

 

638

 

 

 

1,007

 

Total lease cost

$

1,817

 

 

$

2,608

 

 

$

3,911

 

 

$

5,081

 

Supplemental information related to operating and finance leases were the following:

 

 

June 30, 2024

 

Weighted-average remaining lease term, operating leases

5.31 years

 

Weighted-average discount rate, operating leases

 

4.53

%

Weighted-average remaining lease term, finance lease

2.28 years

 

Weighted-average discount rate, finance lease

 

3.61

%

The following is a maturity analysis of operating and finance lease liabilities using undiscounted cash flows on an annual basis with renewal periods included:

 

 

Operating Leases

 

 

Finance Lease

 

 

(in thousands)

 

Year Ending December 31,

 

 

 

 

 

2024 (remaining 6 months)

$

1,389

 

 

$

235

 

2025

 

2,547

 

 

 

468

 

2026

 

1,974

 

 

 

366

 

2027

 

1,886

 

 

 

 

2028

 

712

 

 

 

 

2029

 

514

 

 

 

 

Thereafter

 

1,890

 

 

 

 

Total lease payments

 

10,912

 

 

 

1,069

 

Less imputed interest

 

(1,469

)

 

 

(42

)

Total

$

9,443

 

 

$

1,027

 

 

19


 

Lessor

The Company leases out space in buildings it owns and leases to third-party tenants under noncancelable operating leases. As of June 30, 2024, the remaining lease term is 6 months, including renewal options and may include rent escalation clauses. Lease income primarily represents fixed lease payments from tenants recognized on a straight-line basis over the application lease term. Variable lease income represents tenant payments for real estate taxes, insurance, and maintenance. The lease income was included in interest and other income, net, in the accompanying Condensed Consolidated Statements of Operations, and was not significant for three and six months ended June 30, 2024 and 2023. Future lease payments from tenants as of June 30, 2024 are not significant.

Note 10. Equity-Based Compensation

The Company has included equity-based compensation expense as part of cost of revenue and operating expenses in the accompanying Condensed Consolidated Statements of Operations as follows:

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Cost of revenue

 

$

1,999

 

 

$

2,359

 

 

$

4,008

 

 

$

4,753

 

Research and development

 

 

4,136

 

 

 

3,670

 

 

 

7,980

 

 

 

7,118

 

Selling and marketing

 

 

1,002

 

 

 

1,094

 

 

 

2,052

 

 

 

2,455

 

General and administrative

 

 

4,498

 

 

 

3,200

 

 

 

9,113

 

 

 

6,262

 

Total

 

$

11,635

 

 

$

10,323

 

 

$

23,153

 

 

$

20,588

 

 

Note 11. Income Taxes

The effective tax rate used for interim periods is the estimated annual effective consolidated tax rate, based on the current estimate of full year results, except that taxes related to specific events, if any, are recorded in the interim period in which they occur. The annual effective tax rate is based upon several significant estimates and judgments, including the estimated annual pre-tax income (loss) of the Company in each tax jurisdiction in which it operates, and the development of tax planning strategies during the year. In addition, the Company’s tax expense can be impacted by changes in tax rates or laws and other factors that cannot be predicted with certainty. As such, there can be significant volatility in interim tax provisions.

The Company recorded consolidated benefit from income taxes of $2.1 million and $2.5 million for the three and six months ended June 30, 2024, respectively, compared with $3.1 million and $8.3 million for the three and six months ended June 30, 2023, respectively. The Company’s effective tax rates were 19% and 10% for the three and six months ended June 30, 2024, respectively, compared to 21% and 23% for the three and six months ended June 30, 2023, respectively. The change in the effective tax rate compared to prior periods is due to the valuation allowance in the current period that precludes the Company from recognizing the full benefit from net operating losses.

The Company is under examination by certain tax authorities for the 2020 to 2021 tax years. While the timing of the conclusion of the examination is uncertain, the Company believes that adequate amounts have been reserved for adjustments that may result.

During 2024, the statutes of limitations will lapse on the Company’s 2020 federal tax year and certain 2019 and 2020 state tax years. The Company does not believe the federal or state statute lapses or any other event will significantly impact the balance of unrecognized tax benefits in the next twelve months.

The Company received $0.7 million and $7.0 million in income tax refunds in the three and six months ended June 30, 2024, respectively, and an insignificant amount and $0.7 million in the three and six months ended June 30, 2023, respectively. The income tax refunds received, which were due to overpayment in prior years, were not netted in the income tax paid amounts included in the supplemental disclosure in the accompanying Condensed Consolidated Statements of Cash Flows.

20


 

Note 12. Loss per Share

The following table presents the calculation of basic and diluted loss per share for the three and six months ended June 30, 2024 and 2023:

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Net loss attributable to Fulgent

 

$

(8,710

)

 

$

(11,229

)

 

$

(22,172

)

 

$

(26,569

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares - outstanding, basic

 

 

30,098

 

 

 

29,813

 

 

 

29,933

 

 

 

29,675

 

Weighted-average common shares - outstanding, diluted

 

 

30,098

 

 

 

29,813

 

 

 

29,933

 

 

 

29,675

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

  Basic

 

$

(0.29

)

 

$

(0.38

)

 

$

(0.74

)

 

$

(0.90

)

  Diluted

 

$

(0.29

)

 

$

(0.38

)

 

$

(0.74

)

 

$

(0.90

)

The following securities have been excluded from the calculation of diluted loss per share because their effect would have been anti-dilutive due to the Company's net loss position:

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Stock options

 

 

228

 

 

 

210

 

 

 

228

 

 

 

211

 

Restricted stock units

 

 

2,057

 

 

 

1,274

 

 

 

2,057

 

 

 

1,232

 

Contingently issuable shares

 

 

 

 

 

371

 

 

 

 

 

 

371

 

 

In the three and six months ended June 30, 2023, the Company also had contingently issuable shares for shares held back in connection with the business combination of Fulgent Pharma, or Pharma Hold Back Shares. In May 2024, the Company released the remaining Pharma Hold Back Shares such that no shares remain contingently issuable in connection with the business combination of Fulgent Pharma.

Note 13. Related Parties

Linda Marsh, who is a member of the Company’s Board of Directors, or the Board, currently serves as the Senior Executive Vice President of AHMC Healthcare Inc., or AHMC. The Company performs testing services, on an arms-length basis, for AHMC, and recognized $22,000 and $117,000 in revenue from AHMC in the three and six months ended June 30, 2023, respectively. The revenue recognized for the three and six months ended June 30, 2024 was not significant. As of June 30, 2024 and December 31, 2023, insignificant amounts were owed to the Company by AHMC, which is included in trade accounts receivable, net, in the accompanying Condensed Consolidated Balance Sheets, in connection with this relationship.

Ming Hsieh, the Chief Executive Officer and Chairperson of the Board, is on the board of directors and an approximately 20% owner of ANP, from which the Company entered into certain drug-related licensing and development service agreements. The Chief Executive Officer of Fulgent Pharma, Ray Yin, is the Founder, President and Chief Technology Officer of ANP. The Company incurred $0.3 million and $1.0 million related to the licensing and development services in the three and six months ended June 30, 2024, respectively, and $0.5 million and $1.5 million in the three and six months ended June 30, 2023, respectively. As of June 30, 2024 and December 31, 2023, the Company did not owe anything to ANP in connection with these relationships. The Company also entered into an employee service agreement with ANP in April 2023 and recognized insignificant amounts in the three and six months ended June 30, 2024 and 2023, and insignificant amounts were owed to the Company by ANP in connection with the employee service agreement as of June 30, 2024 and December 31, 2023.

21


 

Note 14. Goodwill and Acquisition-Related Intangibles

There was no change in the carrying amount in the six months ended June 30, 2024. Goodwill, net, as of June 30, 2024 and December 31, 2023 by reporting unit was as follows:

 

 

June 30, 2024

 

 

December 31, 2023

 

 

(in thousands)

 

Goodwill, net:

 

 

 

 

 

Laboratory services

$

 

 

$

 

Therapeutic development

 

22,055

 

 

 

22,055

 

Total

$

22,055

 

 

$

22,055

 

The Company has identified its laboratory services business and its therapeutic development business as its two operating segments, and the Company determined that the two operating segments represented the two reporting units.

The Company tests for goodwill impairment at the reporting unit level on December 31st of each year and more frequently if events or circumstances indicate a potential impairment.

Laboratory Services

The Company recognized a full goodwill impairment loss for the goodwill of its laboratory services reporting unit as of December 31, 2023 due to a continued decline in its share price and market capitalization.

Therapeutic Development

Based upon the results of the quantitative assessments the Company performed as of December 31, 2023, the Company concluded that the fair values of the therapeutic development reporting unit and the IPR&D asset at December 31, 2023, were greater than the carrying values and that there was no impairment. There have been no significant changes in the six months ended June 30, 2024.

There can be no assurance that the estimates and assumptions management made for the purposes of the goodwill or IPR&D impairment analysis will prove to be accurate predictions of future performance. It is possible that the conclusions regarding impairment or recoverability of goodwill or intangible assets could change in future periods. Management will continue to monitor the therapeutic development reporting unit. For all IPR&D projects, there are major risks and uncertainties associated with the timely and successful completion of development and commercialization of these product candidates, including the ability to confirm their efficacy based on data from clinical trials, the ability to obtain necessary regulatory approvals, and the ability to successfully complete these tasks within budgeted costs. The Company is not able to market a human therapeutic without obtaining regulatory approvals, and such approvals require completing clinical trials that demonstrate a product candidate is safe and effective. In addition, the availability and extent of coverage and reimbursement from third-party payors, including government healthcare programs and private insurance plans, impact the revenues a product can generate. Consequently, the eventual realized value, if any, of these acquired IPR&D projects may vary from their estimated fair values.

22


 

Summaries of intangible asset balances as of June 30, 2024 and December 31, 2023 were as follows:

 

 

Weighted-Average Amortization Period

June 30, 2024

 

 

December 31, 2023

 

 

 

(in thousands)

 

Laboratory Services:

 

 

 

 

 

 

Royalty-free technology

10 Years

$

5,091

 

 

$

5,211

 

Less: accumulated amortization

 

 

(1,612

)

 

 

(1,390

)

Royalty-free technology, net

 

 

3,479

 

 

 

3,821

 

 

 

 

 

 

 

 

Customer Relationships

13 Years

 

83,092

 

 

 

83,119

 

Less: accumulated amortization

 

 

(15,827

)

 

 

(12,586

)

Customer relationships, net

 

 

67,265

 

 

 

70,533

 

 

 

 

 

 

 

 

Trade name

8 Years

 

3,790

 

 

 

3,790

 

Less: accumulated amortization

 

 

(1,154

)

 

 

(906

)

Trade name, net

 

 

2,636

 

 

 

2,884

 

 

 

 

 

 

 

 

In-place lease intangible assets

5 Years

 

360

 

 

 

360

 

Less: accumulated amortization

 

 

(151

)

 

 

(116

)

In-place lease intangible assets, net

 

 

209

 

 

 

244

 

 

 

 

 

 

 

 

Laboratory information system platform

5 Years

 

1,860

 

 

 

1,860

 

Less: accumulated amortization

 

 

(1,085

)

 

 

(899

)

Laboratory information system platform, net

 

 

775

 

 

 

961

 

 

 

 

 

 

 

 

Purchased patent

10 Years

 

28

 

 

 

28

 

Less: accumulated amortization

 

 

(9

)

 

 

(8

)

Purchased patent, net

 

 

19

 

 

 

20

 

Total

 

 

74,383

 

 

 

78,463

 

 

 

 

 

 

 

 

Therapeutic Development:

 

 

 

 

 

 

In-process research & development

n/a

 

64,590

 

 

 

64,590

 

Total

 

 

64,590

 

 

 

64,590

 

Total intangible assets, net

 

$

138,973

 

 

$

143,053

 

Acquisition-related intangibles included in the above tables are generally finite-lived and are carried at cost less accumulated amortization, except for IPR&D, which is related to the business combination of Fulgent Pharma in 2022 and has an indefinite life until research and development efforts are completed or abandoned. All other finite-lived acquisition-related intangibles related to the business combinations in 2022 and 2021 are amortized on a straight-line basis over their estimated lives, which approximates the pattern in which the economic benefits of the intangible assets are expected to be realized.

Amortization of intangible assets was $2.0 million and $4.0 million in the three and six months ended June 30, 2024, respectively, and $2.0 million and $3.9 million for the three and six months ended June 30, 2023, respectively.

Based on the carrying value of finite-lived intangible assets recorded as of June 30, 2024, and assuming no subsequent impairment of the underlying assets, the annual amortization expense for intangible assets is expected to be as follows:

 

 

Amounts

 

 

(in thousands)

 

Year Ending December 31,

 

 

2024 (remaining 6 months)

$

3,979

 

2025

 

7,959

 

2026

 

7,657

 

2027

 

7,198

 

2028

 

7,163

 

2029

 

6,906

 

Thereafter

 

33,521

 

Total

$

74,383

 

 

23


 

Note 15. Stock Repurchase Program

In March 2022, the Board authorized a $250.0 million stock repurchase program. Under the stock repurchase program, the Company may repurchase shares from time to time in the open market or in privately negotiated transactions. The stock repurchase program has no expiration from the date of authorization.

During the three and six months ended June 30, 2024, the Company repurchased zero and 10,000 shares of its common stock, respectively, at an aggregate cost of $0.2 million, under the stock repurchase program. During the three and six months ended June 30, 2023, the Company did not repurchase any shares of its common stock. As of June 30, 2024, a total of approximately $150.5 million remained available for future repurchases of its common stock under the stock repurchase program.

Note 16. Retirement Plans

The Company offers a 401(k) retirement savings plan, or the 401(k) Plan, for its employees, including its executive officers, who satisfy certain eligibility requirements. The Internal Revenue Code of 1986, as amended, allows eligible employees to defer a portion of their compensation, within prescribed limits, on a pre-tax basis through contributions to the 401(k) Plan. The Company matches contributions to the 401(k) Plan based on the amount of salary deferral contributions the participant makes to the 401(k) Plan. The Company provides safe harbor match of the employee contribution to his or her 401(k) Plan account. Total Company matching contributions to the 401(k) Plan were $1.0 million and $1.9 million for the three and six months ended June 30, 2024, respectively, and $0.8 million and $1.8 million for the three and six months ended June 30, 2023, respectively.

Note 17. Subsequent Events

As of August 2, 2024, no subsequent events are being reported.

24


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read together with our condensed consolidated financial statements and related notes included in this report. Additionally, pursuant to Instruction 2 to paragraph (b) of Item 303 of Regulation S-K promulgated by the U.S. Securities and Exchange Commission, or SEC, in preparing this discussion and analysis, we presume that readers have access to and have read the discussion and analysis of our financial condition and results of operations included in our annual report on Form 10-K for our fiscal year ended December 31, 2023, filed with the SEC on February 28, 2024, or the 2023 Annual Report. As used in this discussion and analysis and elsewhere in this report, unless the context otherwise requires, the terms “Fulgent,” the “Company,” “we,” “us” and “our” refer to Fulgent Genetics, Inc. and its consolidated subsidiaries.

Forward-Looking Statements

The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or our future performance, and they are based on our current assumptions, expectations and beliefs concerning future developments and their potential effect on our business. The forward-looking statements in this discussion and analysis include statements about, among other things, our future financial and operating performance, our future cash flows and liquidity and our growth strategies, the development of our drug candidates, as well as anticipated trends in our business and industry. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, those described under “Item 1A. Risk Factors” in Part I of the 2023 Annual Report. Moreover, we operate in a competitive and rapidly evolving industry and new risks emerge from time to time. It is not possible for us to predict all of the risks we may face, nor can we assess the impact of all factors on our business or the extent to which any factor or combination of factors could cause actual results to differ from our expectations. In light of these risks and uncertainties, the forward-looking events and circumstances described in this discussion and analysis may not occur, and actual results could differ materially and adversely from those described in or implied by any forward-looking statements we make. Although we have based our forward-looking statements on assumptions and expectations we believe are reasonable, we cannot guarantee future results, levels of activity, performance or achievements or other future events. As a result, forward-looking statements should not be relied on or viewed as predictions of future events, and this discussion and analysis should be read with the understanding that actual future results, levels of activity, performance and achievements may be materially different than our current expectations. The forward-looking statements in this discussion and analysis speak only as of the date of this report, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to actual results or to changes in our expectations.

Overview

We are a technology-based company with a well-established laboratory services business and a therapeutic development business. Our laboratory services business, to which we formerly referred to as our clinical diagnostic business, includes technical laboratory services and professional interpretation of laboratory results by licensed physicians. Our therapeutic development business is focused on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile, or PK profile, of new and existing cancer drugs.

Business Risks and Uncertainties and Other Factors Affecting Our Performance

Our business and prospects are exposed to numerous risks and uncertainties. For more information, see “Item 1A. Risk Factors” in Part I of the 2023 Annual Report. In addition, our performance in any period is affected by a number of other factors. See the description of some of the material factors affecting our performance in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the 2023 Annual Report.

 

25


 

Results of Operations

The table below summarizes the results of our continuing operations for each of the periods presented. For a financial overview relating to our results of operations, including general descriptions of the make-up of material line items of our statement of operations data, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the 2023 Annual Report.

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 Statement of Operation Data:

 

(in thousands, except percentages)

 

Revenue

 

$

71,028

 

 

$

67,853

 

 

$

3,175

 

 

 

5

%

 

$

135,513

 

 

$

134,021

 

 

$

1,492

 

 

 

1

%

Cost of revenue

 

 

44,537

 

 

 

47,281

 

 

 

(2,744

)

 

 

(6

)%

 

 

86,918

 

 

 

94,638

 

 

 

(7,720

)

 

 

(8

)%

Gross profit

 

 

26,491

 

 

 

20,572

 

 

 

5,919

 

 

 

29

%

 

 

48,595

 

 

 

39,383

 

 

 

9,212

 

 

 

23

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

13,486

 

 

 

9,692

 

 

 

3,794

 

 

 

39

%

 

 

24,920

 

 

 

19,474

 

 

 

5,446

 

 

 

28

%

Selling and marketing

 

 

8,595

 

 

 

10,723

 

 

 

(2,128

)

 

 

(20

)%

 

 

17,584

 

 

 

20,806

 

 

 

(3,222

)

 

 

(16

)%

General and administrative

 

 

21,326

 

 

 

17,993

 

 

 

3,333

 

 

 

19

%

 

 

42,815

 

 

 

39,795

 

 

 

3,020

 

 

 

8

%

Amortization of intangible assets

 

 

1,990

 

 

 

1,962

 

 

 

28

 

 

 

1

%

 

 

3,980

 

 

 

3,930

 

 

 

50

 

 

 

1

%

Total operating expenses

 

 

45,397

 

 

 

40,370

 

 

 

5,027

 

 

 

13

%

 

 

89,299

 

 

 

84,005

 

 

 

5,294

 

 

 

6

%

Operating loss

 

 

(18,906

)

 

 

(19,798

)

 

 

892

 

 

 

(5

)%

 

 

(40,704

)

 

 

(44,622

)

 

 

3,918

 

 

 

(9

)%

Interest and other income, net

 

 

7,692

 

 

 

5,098

 

 

 

2,594

 

 

 

51

%

 

 

15,317

 

 

 

8,873

 

 

 

6,444

 

 

 

73

%

Loss before income taxes

 

 

(11,214

)

 

 

(14,700

)

 

 

3,486

 

 

 

(24

)%

 

 

(25,387

)

 

 

(35,749

)

 

 

10,362

 

 

 

(29

)%

Benefit from income taxes

 

 

(2,124

)

 

 

(3,110

)

 

 

986

 

 

 

(32

)%

 

 

(2,451

)

 

 

(8,310

)

 

 

5,859

 

 

 

(71

)%

Net loss from consolidated operations

 

 

(9,090

)

 

 

(11,590

)

 

 

2,500

 

 

 

(22

)%

 

 

(22,936

)

 

 

(27,439

)

 

 

4,503

 

 

 

(16

)%

Net loss attributable to noncontrolling interests

 

 

380

 

 

 

361

 

 

 

19

 

 

 

5

%

 

 

764

 

 

 

870

 

 

 

(106

)

 

 

(12

)%

Net loss attributable to Fulgent

 

$

(8,710

)

 

$

(11,229

)

 

$

2,519

 

 

 

(22

)%

 

$

(22,172

)

 

$

(26,569

)

 

$

4,397

 

 

 

(17

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

26


 

Revenue

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

 

(in thousands, except percentages)

 

Revenue from laboratory services:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Precision diagnostics

 

$

43,144

 

 

$

31,935

 

 

$

11,209

 

 

 

35

%

 

$

80,590

 

 

$

59,840

 

 

$

20,750

 

 

 

35

%

Anatomic pathology

 

 

23,431

 

 

 

27,390

 

 

 

(3,959

)

 

 

(15

)%

 

 

46,538

 

 

 

53,801

 

 

 

(7,263

)

 

 

(14

)%

BioPharma services

 

 

3,612

 

 

 

7,771

 

 

 

(4,159

)

 

 

(54

)%

 

 

6,268

 

 

 

16,191

 

 

 

(9,923

)

 

 

(61

)%

COVID-19

 

 

841

 

 

 

757

 

 

 

84

 

 

 

11

%

 

 

2,117

 

 

 

4,189

 

 

 

(2,072

)

 

 

(50

)%

Total laboratory services

 

$

71,028

 

 

$

67,853

 

 

$

3,175

 

 

 

5

%

 

$

135,513

 

 

$

134,021

 

 

$

1,492

 

 

 

1

%

Revenue increased $3.2 million or 5%, from $67.9 million in the three months ended June 30, 2023 to $71.0 million in the three months ended June 30, 2024. The increase in revenue was due to an increase of $11.2 million in precision diagnostics, partially offset by decreases of $4.0 million in anatomic pathology and $4.2 million in BioPharma services.

Revenue increased $1.5 million or 1%, from $134.0 million in the six months ended June 30, 2023, to $135.5 million in the six months ended June 30, 2024. The increase in revenue was due to an increase of $20.8 million in precision diagnostics, partially offset by decreases of $7.3 million in anatomic pathology, $9.9 million in BioPharma services, and $2.1 million in COVID-19 testing services.

The increase in precision diagnostics revenue was due to a growth in our reproductive health services, and growth in our specialized oncology tests and testing services. The decrease in anatomic pathology services was due to decreased reimbursement rates from third-party payors. We also have experienced and expect to continue to experience seasonality in our anatomic pathology testing services which are dependent on patients being treated by healthcare providers. The volume of our anatomic pathology testing services can fluctuate during holiday periods and can decline due to extreme adverse weather conditions. The decrease in BioPharma services was attributed to timing of BioPharma service projects. We also expect that our BioPharma services revenue may continue to fluctuate from period to period due in part to the length of the sales cycle and variation in timing amongst projects.

We believe the factors that will affect our ability to grow these revenue streams are 1) the average price point we offer and the reimbursement rate from third-party payors; 2) the concentration of our payor base; 3) the competitive advantage we have due to our broad and flexible test menu, detection rate, and turnaround times; and 4) growth in size of an addressable market. Estimated collection amounts from third-party payors are subject to the complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs.

Our customer base includes insurance, institutional, and individual payors. In some periods, our revenue is concentrated on a smaller number of customers. For the laboratory services business, aggregating customers that are under common control, one customer comprised of $16.9 million or 24% of total revenue in the three months ended June 30, 2024, and contributed $29.6 million or 22% of total revenue in the six months ended June 30, 2024. The same customer contributed $9.1 million or 13% of total revenue in the three months ended June 30, 2023, and no customer contributed more than 10% of the Company’s revenue in the six months ended June 30, 2023. To reduce this revenue concentration risk, we continue to focus on increasing the number of customers and thereby reducing the concentration.

Revenue from non-U.S. sources increased $2.0 million or 42%, from $4.8 million in the three months ended June 30, 2023 to $6.8 million in the three months ended June 30, 2024. Revenue from non-U.S. sources increased $4.6 million, or 51%, from $8.9 million in the six months ended June 30, 2023, to $13.5 million in the six months ended June 30, 2024. The increase in revenue from non-U.S. sources between periods were primarily due to new foreign customers and increased sales of our testing services to some of our existing non-U.S. customers.

Cost of Revenue

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

 

(in thousands, except percentages)

 

Cost of revenue

 

$

44,537

 

 

$

47,281

 

 

$

(2,744

)

 

 

(6

)%

 

$

86,918

 

 

$

94,638

 

 

$

(7,720

)

 

 

(8

)%

Cost of revenue as a % of revenue

 

 

63

%

 

 

70

%

 

 

 

 

 

 

 

 

64

%

 

 

71

%

 

 

 

 

 

 

Our consolidated cost of revenue decreased $2.7 million, or 6%, from $47.3 million in the three months ended June 30, 2023 to $44.5 million in the three months ended June 30, 2024. The decrease in consolidated cost of revenue was due to decreases of $2.0 million in consulting and outside labor costs, $0.9 million in software expenses, and $0.8 million in shipping and handling expenses,

27


 

all due to efforts of optimizing cost structures including consolidating service providers and bringing certain processes in house, partially offset by an increase of $0.7 million in facility expenses related to the relocation of our laboratory in Texas.

Our consolidated cost of revenue decreased $7.7 million or 8%, from $94.6 million in the six months ended June 30, 2023 to $86.9 million in the six months ended June 30, 2024. The decrease in consolidated cost of revenue was due to decreases of $4.1 million in consulting and outside labor costs, $1.4 million in shipping and handling expenses, $1.3 million in software expenses, and $0.7 million in reagents and supply expenses, related to the cessation of COVID-19 testing operations, closure of a laboratory, and efforts of optimizing cost structures mentioned above.

Our consolidated cost of revenues as a percentage of revenue decreased from 70% in the three months ended June 30, 2023 to 63% in the three months ended June 30, 2024. Our consolidated cost of revenues as a percentage of revenue decreased from 71% in the six months ended June 30, 2023 to 64% in the six months ended June 30, 2024.

Our gross profit increased $5.9 million, or 29%, from $20.6 million in the three months ended June 30, 2023 to $26.5 million in the three months ended June 30, 2024, and increased $9.2 million, or 23%, from $39.4 million in the six months ended June 30, 2023 to $48.6 million in the six months ended June 30, 2024. Our gross profit as a percentage of revenue, or gross margin, increased from 30% in the three months ended June 30, 2023 to 37% in the three months ended June 30, 2024, and increased from 29% in the six months ended June 30, 2023 to 36% in the six months ended June 30, 2024. The changes were primarily due to efforts of optimizing cost structures mentioned above.

Research and Development

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

2024

 

 

2023

 

 

$ Change

 

 

% Change

 

 

 

(in thousands, except percentages)

 

Research and development

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Laboratory services

 

$

7,334

 

 

$

7,003

 

 

$

331

 

 

 

5

%

 

$

14,655

 

 

$

14,312

 

 

$

343

 

 

 

2

%

Therapeutic development

 

 

6,152

 

 

 

2,689

 

 

 

3,463

 

 

 

129

%

 

 

10,265

 

 

 

5,162

 

 

 

5,103

 

 

 

99

%

Total research and development

 

$

13,486

 

 

$

9,692

 

 

$

3,794

 

 

 

 

 

$

24,920

 

 

$

19,474

 

 

$

5,446

 

 

 

 

Research and development expenses for the laboratory services business were mainly for developing our technology and testing services. The research and development expenses were flat for both periods.

Research and development expenses for the therapeutic development business were primarily related to the development of FID-007. The expenses increased $3.5 million or 129% from $2.7 million in the three months ended June 30, 2023 to $6.2 million in the three months ended June 30, 2024, and increased $5.1 million or 99% from $5.2 million in the six months ended June 30, 2023 to $10.3 million in the six months ended June 30, 2024. The increase was primarily due to increased expenses related to a drug study with our contract research organizations. We anticipate research and development expenditures for this segment to continue to increase as we have begun enrollment for the phase 2 study of FID-007 in the second quarter of 2024.

Selling and Marketing

Our consolidated selling and marketing expenses decreased $2.1 million or 20%, from $10.7 million in the three months ended June 30, 2023 to $8.6 million in the three months ended June 30, 2024. The decrease in consolidated selling and marketing expenses was due to decreases of $0.7 million in personnel expenses, $0.4 million in consulting and outside labor costs, $0.3 million in facility expense, $0.2 million in marketing expenses, and $0.2 million in software expenses.

Our consolidated selling and marketing expenses decreased $3.2 million or 16% from $20.8 million in the six months ended June 30, 2023 to $17.6 million in the six months ended June 30, 2024. The decrease in consolidated selling and marketing expenses was primarily due to decreases of $1.1 million in consulting and outside labor costs, $0.8 million in facility expenses, $0.4 million in marketing expenses, $0.3 million in software expenses, and $0.2 million in commission.

The change in selling and marketing expenses for both periods is mainly due to discontinued marketing efforts related to the COVID-19 business and decreased revenue in BioPharma and anatomic pathology services.

General and Administrative

Our consolidated general and administrative expenses increased $3.3 million or 19%, from $18.0 million in the three months ended June 30, 2023 to $21.3 million in the three months ended June 30, 2024. The increase in consolidated general and

28


 

administrative expenses was due to increases of $2.6 million in personnel costs including equity-based compensation expenses, $0.7 million in legal fees, and $0.2 million in provision for credit losses, partially offset by a decrease of $0.4 million in business insurance.

Our consolidated general and administrative expenses increased $3.0 million or 8% from $39.8 million in the six months ended June 30, 2023 to $42.8 million in the six months ended June 30, 2024. The increase in consolidated general and administrative expenses was due to increases of $4.8 million in personnel expense including equity-based compensation expenses, $0.8 million in facility expenses, $0.6 million in accounting fees, and $0.4 million in legal fees, partially offset by decreases of $2.2 million in provision for credit loss and $1.3 million in business insurance.

The increase in personnel expenses was primarily due to equity awards granted after the second quarter of 2023; the decrease in business insurance was due to savings from consolidating coverages and service providers; the increase in facility expenses was due to the relocation of our facility to Coppell, Texas; and the increase in the accounting fees was due to entities acquired in 2022, which were scoped in for the financial statements and internal control audit and reviews.

Amortization of Intangible Assets

Amortization of intangible assets represents amortization expenses on the intangible assets that arose from the business combinations in prior years. The Company did not have any new business combinations in the current period.

Interest and Other Income, net

Interest and other income, net, is primarily comprised of net interest income (expenses), which was $7.7 million and $15.3 million in three and six months ended June 30, 2024, respectively, and $5.0 million and $8.8 million for the three and six months ended June 30, 2023, respectively. This interest income, net, related to interest earned on various investments in marketable securities including realized gain or loss on sale of marketable securities, net of interest expenses incurred for our notes payable. The increase in interest income, net, was primarily due to increased interest rates on marketable securities relative to the prior comparative period.

Benefit from Income Taxes

Benefit from income taxes was $2.1 million and $2.5 million for the three and six months ended June 30, 2024, respectively, compared with $3.1 million and $8.3 million for the three and six months ended June 30, 2023, respectively. The effective tax rates were 19% and 10% for the three and six months ended June 30, 2024, respectively, compared to 21% and 23% for the three and six months ended June 30, 2023. The change in the effective tax rate compared to prior period is due to the valuation allowance in the current period that precludes us from recognizing the benefit from our net operating losses.

Net Loss Attributable to Noncontrolling Interest

Net loss attributable to noncontrolling interest represents net loss attributable to the minority shareholders from entities not wholly owned.

 

 

Liquidity and Capital Resources

Liquidity and Sources of Cash

We had $837.9 million and $847.7 million in cash, cash equivalents, and marketable securities as of June 30, 2024 and December 31, 2023, respectively. Our marketable securities primarily consist of U.S. government and U.S. agency debt securities, U.S. treasury bills, corporate bonds, municipal bonds, and Yankee debt securities.

Our primary uses of cash are to fund our operations, repurchase our stock, and to fund strategic acquisitions as we continue to invest in and seek to grow our business. Cash used to fund operating expenses is impacted by the timing of our expense payments, as reflected in the changes in our outstanding accounts payable and accrued expenses.

We believe our existing cash, cash equivalents, and short-term marketable securities will be sufficient to meet our anticipated cash requirements for at least the next 12 months. Cash provided by operations has significantly contributed to our ability to meet our

29


 

liquidity needs, including paying for capital expenditures; however, cash provided by our operations has in the past experienced fluctuations from period to period, which we expect may continue in the future. These fluctuations can occur because of a variety of factors, including, among others, factors relating to the demand for our tests, the amount and timing of sales, the prices we charge for our tests due to changes in product mix, customer mix, general price degradation for tests, or other factors, seasonality, the rate and timing of our billing and collections cycles and the timing and amount of our commitments and other payments. Moreover, even if our liquidity expectations are correct, we may still seek to raise additional capital through securities offerings, credit facilities or other debt financings, asset sales or collaborations or licensing arrangements.

If we raise additional funds by issuing equity securities, our existing stockholders could experience substantial dilution. Additionally, any preferred stock we issue could provide for rights, preferences or privileges senior to those of our common stock, and our issuance of any additional equity securities, or the possibility of such an issuance, could cause the market price of our common stock to decline. The terms of any debt securities we issue or borrowings we incur, if available, could impose significant restrictions on our operations, such as limitations on our ability to incur additional debt or issue additional equity or other restrictions that could adversely affect our ability to conduct our business, and would result in increased fixed payment obligations. If we seek to sell assets or enter into collaborations or licensing arrangements to raise capital, we may be required to accept unfavorable terms or relinquish or license to a third party our rights to important or valuable technologies or tests we may otherwise seek to develop ourselves. Moreover, we may incur substantial costs in pursuing future capital, including investment banking, legal and accounting fees, printing and distribution expenses and other similar costs. Additional funding may not be available to us when needed, on acceptable terms or at all. If we are not able to secure funding if and when needed and on reasonable terms, we may be forced to delay, reduce the scope of or eliminate one or more sales and marketing initiatives, research and development programs or other growth plans or strategies. In addition, we may be forced to work with a partner on one or more aspects of our tests or market development programs or initiatives, which could lower the economic value to us of these tests, programs or initiatives. Any such outcome could significantly harm our business, performance and prospects.

Cash Flows

The following table summarizes our cash flows for each of the periods indicated:

 

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Net cash provided by operating activities

 

 

11,551

 

 

$

1,830

 

Net cash used in investing activities

 

 

(39,882

)

 

$

(5,450

)

Net cash used in financing activities

 

 

(3,953

)

 

$

(17,360

)

Operating Activities

During the six months ended June 30, 2024, our operations provided $11.6 million of cash, as compared to $1.8 million provided in the six months ended June 30, 2023. The increase in cash provided from operating activities in the six months ended June 30, 2024, as compared with the corresponding period in 2023 was primarily due to the timing of cash receipts from customers and cash payments for operating expenses. We expect to incur more operating expenses and use more cash in operating activities in the coming quarters as a result of our planned and ongoing clinical trials for FID-007 and as we continue to invest resources to grow our laboratory services business.

Investing Activities

The cash provided by or used in investing activities are impacted by capital expenditures for operation needs and timing of payments, timing of maturities of marketable securities, and discretionary business combinations and other investment.

Cash used in investing activities in the six months ended June 30, 2024 was $39.9 million, which primarily represents $258.8 million for purchases of marketable securities and $17.0 million for purchases of fixed assets, including real estate, partially offset by proceeds of $160.1 million from maturities of marketable securities, and proceeds of $75.6 million from sales of marketable securities.

Cash used in investing activities in the six months ended June 30, 2023 was $5.5 million, which primarily related to $250.5 million on purchases of marketable securities and $14.2 million on purchases of fixed assets, including real estate, partially offset by $258.8 million related to maturities of marketable securities.

Financing Activities

30


 

Cash used in financing activities in the six months ended June 30, 2024 was $4.0 million, which primarily related to $2.2 million common stock withholding for employee tax obligations, $1.2 million for repayment of the notes payable, and $0.2 million for repurchase of common stock.

Cash used in financing activities in the six months ended June 30, 2023 was $17.4 million, which primarily related to $15.0 million repayment to the margin loan account and $1.1 million common stock withholding for employee tax obligations.

We do not expect to use any credit facilities for the foreseeable future due to the strong cash position as of June 30, 2024.

Stock Repurchase Program

In March 2022, the Board authorized a $250.0 million stock repurchase program. Under the stock repurchase program, the Company may repurchase shares from time to time in the open market or in privately negotiated transactions. The stock repurchase program has no expiration from the date of authorization.

During the three and six months ended June 30, 2024, we repurchased zero and 10,000 shares of our common stock, respectively, at an aggregate cost of $0.2 million, under the stock repurchase program. During the three and six months ended June 30, 2023, we did not repurchase any shares of our common stock. As of June 30, 2024, a total of approximately $150.5 million remained available for future repurchases of its common stock under the stock repurchase program.

Critical Accounting Policies and Use of Estimates

There have been no material changes to our critical accounting policies or estimates from the information provided in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in the 2023 Annual Report.

Recent Accounting Pronouncements

See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements included in this report for information about recent accounting pronouncements.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC, that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

For quantitative and qualitative disclosures about market risk, see Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” in our 2023 Annual Report. There were no material changes during the six months ended June 30, 2024.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Disclosure controls and procedures are controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. As required by Rule 13a-15(b) under the Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures as of June 30, 2024. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2024.

31


 

Changes in Internal Control over Financial Reporting

There have not been any changes in our internal control (as required by Rule 13a-15(b) under the Exchange Act) over the financial reporting during the three and six months ended June 30, 2024 that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

Inherent Limitations on Disclosure Controls and Procedures and Internal Control over Financial Reporting

Management recognizes that any controls and procedures, no matter how well-designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the benefits of possible controls and procedures relative to their costs. Because of these inherent limitations, our disclosure and internal controls may not prevent or detect all instances of fraud, misstatements or other control issues. In addition, projections of any evaluation of the effectiveness of disclosure or internal controls to future periods are subject to risks, including, among others, that controls may become inadequate because of changes in conditions or that the degree of compliance with policies or procedures may deteriorate.

32


 

PART II—OTHER INFORMATION

From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. As disclosed in Note 8, Debt, Commitments, and Contingencies, to the Condensed Consolidated Financial Statements, we are engaged in certain legal investigations, audits, and voluntary disclosures processes; and the disclosure set forth in Note 8 relating to these certain legal matters is incorporated herein by reference.

The outcome of litigation is inherently uncertain, and there can be no assurances that favorable outcomes will be obtained.

Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, and reputational harm, among other factors.

Item 1A. Risk Factors.

Except as set forth below and in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, filed with the SEC on May 3, 2024, there have been no material changes to the risk factors set forth in Part I, Item 1A, “Risk Factors,” of the 2023 Annual Report.

We may be required to modify our business practices, pay fines, incur significant expenses, or experience losses due to litigation or governmental investigations.

From time to time and in the ordinary course of our business, we have been and again may be subject to litigation or governmental investigation on a variety of matters in the United States or foreign jurisdictions, including, without limitation, regulatory, intellectual property, product liability, antitrust, consumer, false claims, whistleblower, Qui Tam, privacy, anti-kickback, anti-bribery, environmental, commercial, securities and employment litigation and claims and other legal proceedings that may arise from the conduct of our business. As noted above, we are currently subject to the HRSA audit and have initiated a voluntary disclosure process with the appropriate government contacts. Our activities relating to our products and services are subject to extensive regulation in the United States and foreign jurisdictions. Like many companies in our industry, we have in the ordinary course of business received inquiries, subpoenas, civil investigative demands, or CIDs, and other types of information requests from government authorities. As previously disclosed, we have received a CID issued by the DOJ pursuant to the False Claims Act related to its investigation of allegations of medically unnecessary laboratory testing, improper billing for laboratory testing, and remuneration received or provided in violation of the Anti-Kickback Statute and the Stark Law. This CID requests information and records relating to certain of our customers named in the CID. As we also disclosed in prior filings, the SEC is conducting a non-public formal investigation, which appears to relate to the subject matters raised in the CID requests and our related disclosures and revenues reported in our Exchange Act reports filed for 2018 through 2020. We are fully cooperating with both the SEC and the U.S. Department of Justice in connection with their requests and investigations. On May 6, 2024, the SEC staff, or the Staff, advised the Company that it has made a preliminary determination to recommend that the SEC file an enforcement action against the Company based on a corporate negligence theory, which, if authorized, would allege violations of Sections 17(a)(2) and 17(a)(3) of the Securities Act of 1933, as amended, Sections 13(a), 13(b)(2)(A) and 13(b)(2)(B) of the Exchange Act, and Rules 13a-1, 13a-13, and 12b-20 thereunder. The Company does not believe that any enforcement recommendation is warranted and, on June 7, 2024, responded to the Staff’s preliminary recommendation. The Company is engaged in ongoing discussions with the SEC staff and the DOJ regarding these matters.

We cannot predict when these investigations and matters will be resolved, the outcome of the investigations and matters, or the potential impact on our business, which may ultimately be greater than we expect. In addition, government investigations and litigation generally may divert the attention of our management team and resources from our core business. As such, the time and attention of our management team in responding to these matters may limit their time available to devote to our business, and we may also incur significant expenses or experience losses in relation to these matters. As a result of these matters, we may also be required to alter the conduct of our operations or be subject to other penalties. Any of these circumstances may adversely affect our business, prospects, reputation and results of operations.

33


 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Use of Proceeds from Registered Securities

To date, we have used $146.7 million of the net proceeds from sales of our common stock, of which, $4.5 million was used for contributions to FF Gene Biotech, prior to the FF Gene Biotech acquisition; $126.4 million was used to fund the Company’s operations and a business combination; and $15.8 million was used to pay off the investment margin loan. All other net proceeds from sales of our common stock are invested in investment-grade and interest-bearing securities, such as U.S. government and U.S. agency debt securities, corporate bonds, and municipal bonds. There has been no material change in the planned use of proceeds from the sales of our common stock from that described in the applicable prospectus.

Information on Share Repurchases

In March 2022, our Board authorized a $250.0 million stock repurchase program. The stock repurchase program has no expiration from the date of authorization. Under the stock repurchase program, the Company may repurchase shares from time to time in the open market or in privately negotiated transactions. All purchases listed below were made in the open market at prevailing market prices and were executed pursuant to trading plans we adopted pursuant to Rule 10b5-1under the Exchange Act.

The number of shares of common stock repurchased by the Company under the stock repurchase program and the average price paid per share for the three and six months ended June 30, 2024 are as follows:

 

Period

 

(a) Total Number of Shares Purchased

 

 

(b) Average Price Paid Per Share (1)

 

 

(c) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs

 

 

(d) Maximum Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs

 

March 2024 (3/1/2024-3/31/2024)

 

 

10,000

 

 

$

22.02

 

 

 

10,000

 

 

$

150,461,000

 

Total

 

 

10,000

 

 

 

 

 

 

10,000

 

 

 

 

(1) Includes commissions for the shares repurchased under the stock repurchase program.

Item 5. Other Information

Rule 10b5-1 trading arrangements

During the three and six months ended June 30, 2024, none of our directors or officers adopted or terminated “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.

 

Item 6. Exhibits.

The information required by this Item 6 is set forth on the Exhibit Index that immediately precedes the signature page to this report and is incorporated herein by reference.

34


 

EXHIBIT INDEX

 

 

 

Incorporated by Reference

Exhibit No.

Exhibit Title

Filed with this Form 10-Q

Form

 

Form No.

 

Date Filed

 

 

 

 

 

 

 

 

3.1

Certificate of Incorporation of the registrant, dated May 13, 2016.

 

10-Q

 

001-37894

 

8/14/2017

 

 

 

 

 

 

 

 

3.1.1

Certificate of Amendment to Certificate of Incorporation of the registrant, dated August 2, 2016.

 

10-Q

 

001-37894

 

8/14/2017

 

 

 

 

 

 

 

 

3.1.2

Certificate of Amendment to Certificate of Incorporation of the registrant, dated May 17, 2017.

 

10-Q

 

001-37894

 

8/14/2017

 

 

 

 

 

 

 

 

3.2

Amended and Restated Bylaws of the registrant.

 

10-Q

 

001-37894

 

8/4/2023

 

 

 

 

 

 

 

 

31.1^

Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

 

 

 

 

 

 

 

 

 

 

 

 

 

31.2^

Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

 

 

 

 

 

 

 

 

 

 

 

 

 

32.1*

Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.INS

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.SCH

Inline XBRL Taxonomy Extension Schema Document

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

X

 

 

 

 

 

 

 

 

 

 

 

 

 

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

X

 

 

 

 

 

 

^ Filed herewith.

* Furnished herewith.

 

35


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 FULGENT GENETICS, INC.

Date: August 2, 2024

By:

/s/ Ming Hsieh

Ming Hsieh

Chief Executive Officer

(principal executive officer)

 

Date: August 2, 2024

By:

/s/ Paul Kim

Paul Kim

Chief Financial Officer

(principal financial and accounting officer)

 

36


EX-31.1

 

Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Ming Hsieh, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024 of Fulgent Genetics, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 2, 2024

By:

/s/ Ming Hsieh

Ming Hsieh

Chief Executive Officer

 

 

(principal executive officer)

 

 


EX-31.2

 

Exhibit 31.2

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Paul Kim, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024 of Fulgent Genetics, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 2, 2024

By:

/s/ Paul Kim

 

 

Paul Kim

 

 

Chief Financial Officer

 

 

(principal financial and accounting officer)

 

 


EX-32.1

 

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024 of Fulgent Genetics, Inc. (the “Company”), as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned hereby certifies in his capacity as the specified officer of the Company, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of his knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: August 2, 2024

By:

/s/ Ming Hsieh

Ming Hsieh

Chief Executive Officer

 

 

 

(principal executive officer)

 

 

 

 

Date: August 2, 2024

 

By:

/s/ Paul Kim

 

 

 

Paul Kim

Chief Financial Officer

 

 

 

(principal financial and accounting officer)

 

This certification accompanies the Quarterly Report on Form 10-Q to which it relates and shall not be deemed filed with the Securities and Exchange Commission or incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.