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DBV Technologies(DBVT) - 2023 Q3 - Quarterly Report
DBVTDBV Technologies(DBVT)2023-10-30 16:00
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Financial Performance - Operating income increased by 14% to 2.4millioninQ32023comparedto2.4 million in Q3 2023 compared to 2.1 million in Q3 2022, driven by revenue from the Nestlé collaboration agreement[101][102][103] - Net loss improved by 3% to 16.7millioninQ32023comparedto16.7 million in Q3 2023 compared to 17.3 million in Q3 2022[101] - Net loss for the nine months ended September 30, 2023 was 61.5million,anincreaseof861.5 million, an increase of 8% compared to 57.0 million in the same period of 2022[114] - Operating income increased by 11% to 6.9millionfortheninemonthsendedSeptember30,2023,drivenbya6.9 million for the nine months ended September 30, 2023, driven by a 0.5 million increase in the French research tax credit[115][116] - Net loss for the nine months ended September 30, 2023 was 61.5million,comparedto61.5 million, compared to 57.0 million in the same period in 2022, representing an 8% increase[114] - The company has incurred net losses annually since inception, primarily due to development programs and administrative expenses[129] Research and Development - Research and Development expenses increased from 3.186millioninQ32022to3.186 million in Q3 2022 to 3.663 million in Q3 2023[81] - Research and development expenses decreased by 9% to 13.8millioninQ32023from13.8 million in Q3 2023 from 15.1 million in Q3 2022, primarily due to a 4.2millionreversaloflossatcompletionfortheNestleˊPhaseIItrial[101][105]−Externalclinical−relatedexpensesincreasedby104.2 million reversal of loss at completion for the Nestlé Phase II trial[101][105] - External clinical-related expenses increased by 10% to 12.3 million in Q3 2023 from 11.1 million in Q3 2022, driven by differences in clinical trial phasing[105][106] - Employee-related costs (excluding share-based payments) for R&D increased by 21% to 3.2 million in Q3 2023 from 2.6millioninQ32022,supportingtheVITESSEtrialandnewtoddlersafetystudy[105][106]−ResearchandDevelopmentexpensesincreasedby32.6 million in Q3 2022, supporting the VITESSE trial and new toddler safety study[105][106] - Research and Development expenses increased by 3% to 47.4 million for the nine months ended September 30, 2023, primarily due to a 4.0millionincreaseinexternalclinical−relatedexpenses[119]−Researchanddevelopmentexpensestotaled4.0 million increase in external clinical-related expenses[119] - Research and development expenses totaled 47.4 million for the nine months ended September 30, 2023, an increase of 1.5millioncomparedtothesameperiodin2022[22]ClinicalTrialsandSafetyStudies−Thecompanyplanstoinitiateasafetystudywithapproximately275additionalsubjectstosupplementthesafetydatafromtheVITESSEtrial[94]−TheFDAconfirmedthatthePhase3EPITOPEstudymeetspre−specifiedcriteriaforsuccess,requiringadditionalsafetydataforBLAsubmission[96]−ThecompanyexpectstoplineresultsfromtheVITESSEtrialinthefirsthalfof2025[95]−TheCOMFORTToddlerssafetystudywillenrollapproximately400subjectswitha3:1randomization(active:placebo)[98]−Thecompany′sViaskinPeanutprogramhasbeenevaluatedinnineclinicaltrials,includingfourPhase2trialsandthreecompletedPhase3trials[93]ExpensesandCosts−Totalpersonnelexpensesincreasedfrom1.5 million compared to the same period in 2022[22] Clinical Trials and Safety Studies - The company plans to initiate a safety study with approximately 275 additional subjects to supplement the safety data from the VITESSE trial[94] - The FDA confirmed that the Phase 3 EPITOPE study meets pre-specified criteria for success, requiring additional safety data for BLA submission[96] - The company expects topline results from the VITESSE trial in the first half of 2025[95] - The COMFORT Toddlers safety study will enroll approximately 400 subjects with a 3:1 randomization (active:placebo)[98] - The company's Viaskin Peanut program has been evaluated in nine clinical trials, including four Phase 2 trials and three completed Phase 3 trials[93] Expenses and Costs - Total personnel expenses increased from 4.922 million in Q3 2022 to 6.724millioninQ32023[81]−Salesandmarketingexpensesincreasedby3186.724 million in Q3 2023[81] - Sales and marketing expenses increased by 318% to 0.7 million in Q3 2023 from 0.2millioninQ32022,mainlyduetohigherexternalprofessionalservices[101][107]−Generalandadministrativeexpensesincreasedby280.2 million in Q3 2022, mainly due to higher external professional services[101][107] - General and administrative expenses increased by 28% to 6.2 million in Q3 2023 from 4.8millioninQ32022[101]−GeneralandAdministrativeexpensesincreasedby304.8 million in Q3 2022[101] - General and Administrative expenses increased by 30% to 22.3 million for the nine months ended September 30, 2023, mainly due to 2.2millioninone−timecostsrelatedtofinancingactivitiesandorganizationalplanning[122][123]−SalesandMarketingexpensesdecreasedby32.2 million in one-time costs related to financing activities and organizational planning[122][123] - Sales and Marketing expenses decreased by 3% to 1.6 million for the nine months ended September 30, 2023, primarily due to a 0.3milliondecreaseinemployee−relatedcosts[121]−Generalandadministrativeexpensesincreasedby0.3 million decrease in employee-related costs[121] - General and administrative expenses increased by 5.1 million to 22.3millionfortheninemonthsendedSeptember30,2023[22]−Thecompanyrecordedaprovisionof22.3 million for the nine months ended September 30, 2023[22] - The company recorded a provision of 0.8 million as of September 30, 2023, for potential costs if the Montrouge office lease agreement is not renewed[123] Cash Flow and Liquidity - Total cash and cash equivalents decreased from 209.194millioninDecember2022to209.194 million in December 2022 to 149.135 million in September 2023[63] - Net cash used in operating activities was 66.0millionfortheninemonthsendedSeptember30,2023,comparedto66.0 million for the nine months ended September 30, 2023, compared to 31.8 million in the same period of 2022[127] - Cash and cash equivalents decreased to 149.1millionasofSeptember30,2023,from149.1 million as of September 30, 2023, from 209.2 million as of December 31, 2022[127] - Net cash flows provided by financing activities were 7.0millionfortheninemonthsendedSeptember30,2023,comparedto7.0 million for the nine months ended September 30, 2023, compared to 194.4 million in the same period of 2022[127] - The company expects its cash and cash equivalents to fund operations for at least the next 12 months[128] - Net cash flow used in operating activities increased by 34.2million(10834.2 million (108%) to 66.0 million for the nine months ended September 30, 2023[140][141] - Net cash flow provided by financing activities decreased by 187.4million(−96187.4 million (-96%) to 7.0 million for the nine months ended September 30, 2023[140][143] - The company issued 15.3millionand15.3 million and 7.8 million in new Ordinary Shares through its ATM program in May 2022 and June 2023, respectively[132] - The company's corporate headquarters in Montrouge, France represents a 1.2millioncashrequirementasofSeptember30,2023[134]−Thecompany′sU.S.officeinBaskingRidge,NewJerseyrepresentsa1.2 million cash requirement as of September 30, 2023[134] - The company's U.S. office in Basking Ridge, New Jersey represents a 0.1 million cash requirement as of September 30, 2023[135] - The company may seek additional capital through public or private equity, debt financings, collaborations, or other non-dilutive financings to support the potential launch of Viaskin Peanut and other R&D efforts[130] - The company established an ATM program to sell up to 100millioninADSs,with100 million in ADSs, with 15.3 million and 7.8millionraisedinMay2022andJune2023,respectively[131][132]−Netcashflowusedininvestingactivitiesincreasedby7.8 million raised in May 2022 and June 2023, respectively[131][132] - Net cash flow used in investing activities increased by 0.6 million (839%) to 0.6millionfortheninemonthsendedSeptember30,2023[140][142]−Thecompany′scorporateheadquartersleaseinMontrouge,France,representsa0.6 million for the nine months ended September 30, 2023[140][142] - The company's corporate headquarters lease in Montrouge, France, represents a 1.2 million cash requirement as of September 30, 2023[134] - The company's U.S. office lease in Basking Ridge, New Jersey, represents a 0.1millioncashrequirementasofSeptember30,2023[135]FinancialIncomeandTaxCredits−Financialincomeincreasedby1100.1 million cash requirement as of September 30, 2023[135] Financial Income and Tax Credits - Financial income increased by 110% to 1.5 million in Q3 2023 from 0.7millioninQ32022[101]−Otheroperatingincomeincreasedby700.7 million in Q3 2022[101] - Other operating income increased by 70% to 1.1 million in Q3 2023 from 0.7millioninQ32022[102]−Researchtaxcreditdecreasedby120.7 million in Q3 2022[102] - Research tax credit decreased by 12% to 1.2 million in Q3 2023 from 1.4millioninQ32022[102]−Financialincomeincreasedby791.4 million in Q3 2022[102] - Financial income increased by 79% to 3.0 million for the nine months ended September 30, 2023, compared to 1.7millioninthesameperiodof2022[124]CorporateandOrganizationalUpdates−ThecompanyannouncedtheappointmentofVirginieBoucinhaasCFOeffectiveNovember6,2023[88]−Thecompanyqualifiesasasmallerreportingcompany,withpotentialmarketvaluethresholdsof1.7 million in the same period of 2022[124] Corporate and Organizational Updates - The company announced the appointment of Virginie Boucinha as CFO effective November 6, 2023[88] - The company qualifies as a smaller reporting company, with potential market value thresholds of 250 million or $700 million depending on revenue and shareholding criteria[145]