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Autolus(AUTL) - 2024 Q2 - Quarterly Report
AUTLAutolus(AUTL)2024-08-08 20:21
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Financial Performance - For the three months ended June 30, 2024, the company incurred a net loss of 58.3million,comparedtoanetlossof58.3 million, compared to a net loss of 45.6 million for the same period in 2023, representing a 28.9% increase in losses year-over-year[138]. - For the six months ended June 30, 2024, the company reported net losses of 111.0million,upfrom111.0 million, up from 85.4 million in the same period in 2023, indicating a 29.9% increase in losses[138]. - The company reported a net loss of 58.3millionforQ22024,comparedtoanetlossof58.3 million for Q2 2024, compared to a net loss of 45.6 million in Q2 2023, representing a 28% increase in losses[160]. - Net loss before income tax was 110.9millionforthesixmonthsendedJune30,2024,a30110.9 million for the six months ended June 30, 2024, a 30% increase from 85.3 million in 2023[175]. Cash and Liquidity - As of June 30, 2024, the company had an accumulated deficit of 989.5million,comparedto989.5 million, compared to 878.6 million as of December 31, 2023[138]. - The company had cash and cash equivalents of 705.9millionasofJune30,2024,whichisexpectedtofundcurrentandplannedoperatingexpensesforatleastthenexttwelvemonths[138].−CashandcashequivalentsasofJune30,2024,totaled705.9 million as of June 30, 2024, which is expected to fund current and planned operating expenses for at least the next twelve months[138]. - Cash and cash equivalents as of June 30, 2024, totaled 705.9 million[183]. - As of June 30, 2024, the company had cash and cash equivalents of 705.9million,upfrom705.9 million, up from 239.6 million as of December 31, 2023[201]. - The company expects its current cash and cash equivalents to be sufficient to fund operating expenses and capital expenditures for at least the next twelve months[192]. - Net cash used in operating activities was 91.6millionforthesixmonthsendedJune30,2024,comparedto91.6 million for the six months ended June 30, 2024, compared to 80.6 million in 2023[186]. - Net cash provided by financing activities was 559.4millionforthesixmonthsendedJune30,2024,primarilyfromproceedsraisedfromBioNTechAgreementsandanunderwrittenoffering[189].−Approximately30559.4 million for the six months ended June 30, 2024, primarily from proceeds raised from BioNTech Agreements and an underwritten offering[189]. - Approximately 30% of the company's cash and cash equivalents were denominated in pound sterling and 70% in U.S. dollars as of June 30, 2024, highlighting the company's exposure to foreign currency risk[202]. - The company maintains significant amounts of cash in excess of federally insured limits, which are placed with financial institutions for varying periods[201]. Revenue and Income - The company has not generated any revenue from commercial product sales, with total revenue to date primarily from license agreements[142]. - License revenue for the six months ended June 30, 2024, was 10.1 million, a 681% increase from 1.3millionforthesameperiodin2023[172].−Interestincomesurgedto1.3 million for the same period in 2023[172]. - Interest income surged to 9.7 million in Q2 2024, up from 3.4millioninQ22023,indicatingasignificantincreaseof1853.4 million in Q2 2023, indicating a significant increase of 185% due to higher yields and account balances[168]. - Interest income increased by 142% to 16.6 million for the six months ended June 30, 2024, from 6.8millionin2023[180].−Otherincome(expense),netroseto6.8 million in 2023[180]. - Other income (expense), net rose to 1.2 million in Q2 2024 from 0.5millioninQ22023,primarilyduetofavorableforeigncurrencyexchangerates[167].Expenses−Totaloperatingexpensesincreasedby170.5 million in Q2 2023, primarily due to favorable foreign currency exchange rates[167]. Expenses - Total operating expenses increased by 17% to 97.7 million for the six months ended June 30, 2024, compared to 83.5millionforthesameperiodin2023[175].−Researchanddevelopmentexpensesareexpectedtoincreasesubstantiallyoverthenextfewyearsduetoadditionalclinicaltrialsandregulatoryfilings[149].−Researchanddevelopmentexpensesroseto83.5 million for the same period in 2023[175]. - Research and development expenses are expected to increase substantially over the next few years due to additional clinical trials and regulatory filings[149]. - Research and development expenses rose to 36.6 million in Q2 2024 from 33.2millioninQ22023,markinga1033.2 million in Q2 2023, marking a 10% increase, primarily driven by clinical trial costs and increased salaries[159][163]. - Research and development expenses rose by 11% to 67.3 million for the six months ended June 30, 2024, up from 60.6millionin2023[175].−Generalandadministrativeexpensesincreasedby9660.6 million in 2023[175]. - General and administrative expenses increased by 96% to 40.1 million for the six months ended June 30, 2024, compared to 20.4millionin2023[176].−Interestexpenseincreasedto20.4 million in 2023[176]. - Interest expense increased to 10.2 million in Q2 2024 from 5.0millioninQ22023,reflectinga1045.0 million in Q2 2023, reflecting a 104% rise attributed to higher liabilities for future royalties and milestones[169]. - Interest expense surged by 197% to 29.4 million for the six months ended June 30, 2024, compared to 9.9millionin2023[181].−DirectresearchanddevelopmentexpensesforBcellmalignanciesincreasedby869.9 million in 2023[181]. - Direct research and development expenses for B cell malignancies increased by 86% to 7.7 million in Q2 2024 from 4.1millioninQ22023[161].ClinicalDevelopmentandRegulatory−Thecompany’sobe−celBLAforrelapsed/refractoryadultB−cellAcuteLymphoblasticLeukemiaisontrackforanFDAtargetactiondateofNovember16,2024[139].−ThepooledanalysisoftheFELIXPhase1b/2studyshowedthat404.1 million in Q2 2023[161]. Clinical Development and Regulatory - The company’s obe-cel BLA for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia is on track for an FDA target action date of November 16, 2024[139]. - The pooled analysis of the FELIX Phase 1b/2 study showed that 40% of patients treated with obe-cel are in ongoing remission, with 99 responders noted[139]. - The company expects initial clinical data from the Phase 1 dose confirmation study in refractory systemic lupus erythematosus patients in late 2024[140]. - The company entered into a distribution services agreement with a subsidiary of Cardinal Health to support the ordering and distribution of obe-cel in the U.S. upon regulatory approval[141]. - The company anticipates incurring significant commercialization expenses if regulatory approval is received for its product candidates, including manufacturing, sales, and marketing costs[192]. Tax and Accounting - The company accumulated tax losses for carry forward in the U.K. amounting to 418.1 million as of December 31, 2023, with a valuation allowance recognized against the deferred tax asset[158]. - The company expects to benefit from U.K. R&D tax credits, with an increase of 1.8millionincreditsduetoqualifyingexpendituresundertheSMEscheme[163].−AmaterialweaknessininternalcontroloverfinancialreportingwasidentifiedrelatedtothemisinterpretationofASC740regardingU.K.SMEtaxcredits,whichwasremediatedbyJune30,2024[204].−Thecompanyidentifiedamaterialweaknessininternalcontrolsrelatedtoaccountingforcomplextransactions,whichhasbeenaddressedthrougharemediationplan[203].−Thecompanyhasidentifiedasecondmaterialweaknessrelatedtoaccountingforcomplextransactions,particularlyconcerningtheBioNTechAgreements[203].−TherewerenomaterialchangesininternalcontroloverfinancialreportingduringthethreemonthsendedJune30,2024,exceptfortheremediationprocessesdescribed[204].ForeignExchangeandRiskManagement−Thecompanyrecordedforeignexchangegainsof1.8 million in credits due to qualifying expenditures under the SME scheme[163]. - A material weakness in internal control over financial reporting was identified related to the misinterpretation of ASC 740 regarding U.K. SME tax credits, which was remediated by June 30, 2024[204]. - The company identified a material weakness in internal controls related to accounting for complex transactions, which has been addressed through a remediation plan[203]. - The company has identified a second material weakness related to accounting for complex transactions, particularly concerning the BioNTech Agreements[203]. - There were no material changes in internal control over financial reporting during the three months ended June 30, 2024, except for the remediation processes described[204]. Foreign Exchange and Risk Management - The company recorded foreign exchange gains of 1.2 million for the three months ended June 30, 2024, compared to gains of 0.4millionforthesameperiodin2023[202].−Thecompanyrecordedforeignexchangelossesof0.4 million for the same period in 2023[202]. - The company recorded foreign exchange losses of 0.5 million for the six months ended June 30, 2024, compared to gains of 1.3millionforthesameperiodin2023[202].−Thecompanyhasnotengagedincurrencyhedgingactivitiesbutmayconsideritinthefuturetomanageforeigncurrencyexposure[202].−Animmediatehypotheticalonepercentagepointchangeininterestrateswouldhaveresultedina1.3 million for the same period in 2023[202]. - The company has not engaged in currency hedging activities but may consider it in the future to manage foreign currency exposure[202]. - An immediate hypothetical one percentage point change in interest rates would have resulted in a 2.1 million increase in interest income for the year ended December 31, 2023[201].