Financial Data and Key Metrics Changes - As of September 30, 2023, the company's cash and cash equivalents decreased to $149.1 million from $209.2 million as of December 31, 2022, representing a net decrease of $60.1 million, primarily due to $66 million used in operating activities related to clinical work and the initiation of the VITESSE trial [7][35] - The company anticipates sufficient cash to fund operations through 2025, although it may consider raising capital in the future [39] Business Line Data and Key Metrics Changes - The company is advancing two clinical programs for Viaskin Peanut: one for toddlers aged 1 to 3 and another for children aged 4 to 7, with both programs expected to support distinct Biologics License Applications (BLAs) [13][36] - The COMFORT Toddlers study will include 400 subjects, while the COMFORT Children study will include 270 subjects, with both studies designed to generate adhesion data [15][34] Market Data and Key Metrics Changes - The company is focused on the U.S. market for the potential approval of its Viaskin Peanut therapy, with the successful completion of the COMFORT studies being a critical step towards filing for marketing approval [18][36] Company Strategy and Development Direction - The company aims to harmonize the approach to product usage across its safety studies, simplifying the language and aligning eligibility criteria with previous successful studies [25][34] - The initiation of the COMFORT Toddlers study is expected in the first quarter of 2024, with the COMFORT Children study to follow closely [10][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the engagement and clarity of feedback received from the FDA, which is expected to facilitate the enrollment of subjects in the upcoming studies [34] - The company remains committed to maximizing efficiency in spending and maintaining disciplined cash management as it progresses through its clinical trials [27] Other Important Information - The company has received regulatory guidance from the FDA confirming that the Phase III EPITOPE study met the prespecified criteria for success, eliminating the need for an additional efficacy study [24] - The protocols for the supplemental safety studies will be submitted to the FDA, with the expectation of initiating enrollment shortly thereafter [18][36] Q&A Session Summary Question: What impact does the need for food challenges in COMFORT Toddlers have on anticipated timelines? - Management acknowledged that while the food challenge could add time to the recruitment period, they are confident in their sites' capabilities and understanding of the product, which should facilitate the process [29] Question: Does the food challenge requirement impact the potential cost of the trial? - Management indicated that the addition of the food challenge will not significantly affect the trial's cost and confirmed that they have sufficient cash to fund operations through 2025 [39]

Financial Performance - Operating income increased by 14% to $2.4 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 $16.7 million in Q3 2023 compared to $17.3 million in Q3 2022[101] - Net loss for the nine months ended September 30, 2023 was $61.5 million, an increase of 8% compared to $57.0 million in the same period of 2022[114] - Operating income increased by 11% to $6.9 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 $61.5 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 $3.186 million in Q3 2022 to $3.663 million in Q3 2023[81] - Research and development expenses decreased by 9% to $13.8 million in Q3 2023 from $15.1 million in Q3 2022, primarily due to a $4.2 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 $2.6 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 $4.0 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 $1.5 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 $6.724 million in Q3 2023[81] - Sales and marketing expenses increased by 318% to $0.7 million in Q3 2023 from $0.2 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 $4.8 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 $2.2 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 $0.3 million decrease in employee-related costs[121] - General and administrative expenses increased by $5.1 million to $22.3 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 $209.194 million in December 2022 to $149.135 million in September 2023[63] - Net cash used in operating activities was $66.0 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 $149.1 million as of September 30, 2023, from $209.2 million as of December 31, 2022[127] - Net cash flows provided by financing activities were $7.0 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 $34.2 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 $187.4 million (-96%) to $7.0 million for the nine months ended September 30, 2023[140][143] - The company issued $15.3 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 $1.2 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 $100 million in ADSs, with $15.3 million and $7.8 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 $0.6 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 $0.1 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 $0.7 million in Q3 2022[101] - Other operating income increased by 70% to $1.1 million in Q3 2023 from $0.7 million in Q3 2022[102] - Research tax credit decreased by 12% to $1.2 million in Q3 2023 from $1.4 million in Q3 2022[102] - Financial income increased by 79% to $3.0 million for the nine months ended September 30, 2023, compared to $1.7 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]

Financial Data and Key Metrics Changes - As of June 30, 2023, cash and cash equivalents were $174 million, a decrease of $35.2 million from $209.2 million as of December 31, 2022 [47] - Operating activities used $46.4 million in cash, primarily driven by clinical R&D, with a significant component being the initiation of the VITESSE Phase 3 trial [47] - Cash used for operations in the first half of 2023 increased by $34.7 million compared to the same period in 2022 [47] Business Line Data and Key Metrics Changes - The Viaskin Peanut program is advancing in parallel for toddlers (ages 1-3) and children (ages 4-7), with independent clinical and regulatory paths for each [43] - The supplemental safety study for toddlers will include approximately 400 subjects, while the study for children will include about 270 subjects, bringing the total safety database to approximately 600 subjects on active treatment [55][56] Market Data and Key Metrics Changes - The company received €24.8 million for reimbursement of French research tax credits for the years 2019-2021 during the first half of 2022 [21] - The company raised $7.8 million from the issuance and sale of new ordinary shares in the form of American Depositary Shares on June 16, 2023 [21] Company Strategy and Development Direction - The successful completion of the supplemental COMFORT Toddlers safety study is viewed as a crucial step towards filing a Biologics License Application (BLA) for marketing approval [48] - The company is focused on maximizing the efficiency of its spending and maintaining disciplined cash management to support ongoing clinical work [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing progress of the VITESSE trial, with expectations to have the last patient enrolled in the first half of next year and top-line results anticipated in the first half of 2025 [51] - The FDA has not raised specific safety concerns regarding the Viaskin Peanut development program, indicating a consistent communication from the agency [55] Other Important Information - The Phase 3 EPITOPE study results were published in the New England Journal of Medicine, highlighting the efficacy of Viaskin Peanut [44] - The company is actively finalizing protocols for the supplemental safety studies and expects to submit them to the FDA for a formal 90-day review [46] Q&A Session Summary Question: What protocol details are being aligned with the FDA? - The company is working to finalize the protocol and will submit it to the FDA once completed [50] Question: Will the cash runway guidance change with the agreement on high-level details from the FDA? - Management indicated that the feedback from the FDA does not change their clinical trial planning or financial projections [27] Question: Can you provide an update on the VITESSE enrollment? - Enrollment is proceeding as expected, with no changes to the previously provided guidance regarding patient enrollment timelines [51]

Financial Performance - The company reported a net loss of $24.2 million for the three months ended June 30, 2023, compared to a net loss of $23.0 million for the same period in 2022, indicating an increase in loss of about 5.3%[22] - Net loss for the six months ended June 30, 2023, was $44.804 million, compared to a net loss of $39.746 million for the same period in 2022, representing an increase of approximately 12.9%[25] - Basic/diluted net loss per share attributable to shareholders was $0.26 for the three months ended June 30, 2023, compared to $0.35 for the same period in 2022, indicating a decrease in loss per share of about 25.7%[22] - Total comprehensive loss for the six months ended June 30, 2023, was $41.5 million, compared to $52.8 million for the same period in 2022, reflecting a decrease of about 21.4%[22] - Net loss for the three months ended June 30, 2023, was $24.2 million, compared to a net loss of $23.0 million in the same period of 2022, with net loss per share improving from $(0.35) to $(0.26)[116] Assets and Liabilities - As of June 30, 2023, total assets decreased to $217.5 million from $246.5 million as of December 31, 2022, representing a decline of approximately 11.7%[18] - Total current liabilities increased to $33.4 million as of June 30, 2023, from $29.5 million as of December 31, 2022, marking an increase of about 13.1%[18] - Cash and cash equivalents decreased to $174.0 million as of June 30, 2023, from $209.2 million as of December 31, 2022, a decline of approximately 16.4%[18] - Total current assets decreased from $223,074 thousand as of December 31, 2022, to $195,539 thousand as of June 30, 2023, a decline of approximately 12.4%[18] - The company’s total shareholders' equity as of June 30, 2023, was $164.240 million, a decrease from $244.416 million at the end of June 30, 2022[29] Research and Development - Research and development expenses for the six months ended June 30, 2023, were $33.7 million, up from $30.8 million in the same period of 2022, reflecting an increase of approximately 9.4%[22] - The company is focused on developing a modified Viaskin Peanut patch, with ongoing studies to assess safety and efficacy, including the STAMP study[40] - The company is focused on building its sales and marketing capabilities to commercialize Viaskin Peanut and other product candidates, if approved[14] - The company is advancing regulatory efforts for VP in toddlers aged 1-3 years with confirmed peanut allergy following positive clinical trial results[99] - The company plans to conduct a new safety study for Viaskin Peanut in children aged 1-3 years, following FDA confirmation that the EPITOPE study met the pre-specified criteria for success[51][57] Clinical Trials and Regulatory Milestones - The company anticipates the re-submission of a Biologics License Application for Viaskin™ Peanut to the FDA, which is a key future milestone[14] - The FDA lifted a partial clinical hold on the VITESSE study on December 23, 2022, allowing the trial to proceed with a revised protocol[48] - The first patient was screened in the VITESSE study on March 7, 2023, with the last patient screening anticipated in the first half of 2024 and topline results expected in the first half of 2025[50][61] - The FDA confirmed that the Phase 3 EPITOPE study for Viaskin Peanut meets the pre-specified criteria for success, requiring additional safety data for a BLA submission[98] - The company has completed enrollment for Part B of the EPITOPE study, which included 362 subjects aged 1-3 years, with 244 in the active arm and 118 in the placebo arm[56] Expenses and Cash Flow - Net cash flow used in operating activities for the six months ended June 30, 2023, was $(46.394) million, significantly higher than $(11.733) million for the same period in 2022[25] - General and administrative expenses increased by $3.5 million to $9.2 million for the three months ended June 30, 2023, mainly due to one-time costs associated with financing activities and market research[112] - Sales and marketing expenses decreased by $0.6 million (37%) to $950 million for the six months ended June 30, 2023, primarily due to reductions in external professional services and employee-related costs[125][126] - The company reported a significant increase in expenses related to share-based payments, totaling $3.446 million for the six months ended June 30, 2023, compared to $2.441 million in the same period of 2022, an increase of approximately 41.2%[25] - Net cash used in operating activities increased by $34.7 million (295%) to $46.4 million for the six months ended June 30, 2023, primarily due to the repayment of research tax credit receivable[145] Shareholder Information - The total number of ordinary shares increased from 94,137,145 on January 1, 2023, to 96,250,954 by June 30, 2023, due to the issuance of new shares[29] - The company raised $7.8 million through the issuance of new ordinary shares in June 2023 under the At-The-Market program[62] - The company has not incurred any bank debt and has relied on financing activities to support operations[133] - The company intends to seek additional capital for the launch of Viaskin Peanut and ongoing research and development efforts[134] - The company granted 59,200 stock options and 35,800 restricted stock units to employees during the six months ended June 30, 2023[77]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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 001-36697 DBV TECHNOLOGIES S.A. (Exact name of registrant as specified in its charter) State or other jurisdiction ...

DBV Technologies S.A. (NASDAQ:DBVT) Q4 2022 Results Conference Call March 2, 2023 5:00 PM ET Company Participants Anne Pollak - Head IR Daniel Tassé - CEO Sébastien Robitaille - CFO Pharis Mohideen - Chief Medical Officer Conference Call Participants Jon Wolleben - JMP Operator Good day, and welcome to the DBV Technologies Full Year 2022 Financial Results Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Ms. Anne Pollak, Head o ...

Financial Performance - The company incurred net losses of $96.3 million and $97.8 million for the years ended December 31, 2022 and 2021, respectively, with an accumulated deficit of $259.6 million as of December 31, 2022[232]. - As of December 31, 2022, the company had cash and cash equivalents of $209.2 million, expected to fund operations for at least the next 12 months[236][244]. - The company has not generated any product revenue and continues to advance the clinical and regulatory development of Viaskin Peanut in the United States and European Union[232][243]. - Future revenues will depend on the successful development, regulatory approval, and commercialization of Viaskin Peanut, with anticipated significant expenses and operating losses[235][242]. - The company plans to seek additional capital through public or private equity or debt financings, collaborations, and other forms of non-dilutive financing as it prepares for the potential launch of Viaskin Peanut[237][245]. - The company may face challenges in obtaining necessary financing due to disruptions in global financial markets, particularly as a result of the COVID-19 pandemic[239][246]. - The company expects its research and development expenses to increase substantially as it seeks regulatory approval for Viaskin Peanut and develops the necessary commercialization infrastructure[242]. - The company is limited in its ability to raise additional share capital under French law, which may complicate future fundraising efforts[250]. - Economic downturns, inflation, and geopolitical events could adversely affect the company's business and financial performance[252][255]. - The COVID-19 pandemic has caused significant disruptions that may continue to impact the company's ability to conduct clinical trials and access capital[256][258]. Regulatory and Clinical Development - The company is currently conducting a Phase 3 pivotal study (VITESSE) for the modified Viaskin Peanut system in children aged 4-7 years, which is crucial for seeking regulatory approval[275]. - The company has no drug or biological product approved for sale and may never be able to develop a marketable drug or biological product[273]. - The development of biopharmaceutical products is capital-intensive, and the company anticipates requiring additional financing to fund operations[264]. - The company may face significant challenges in obtaining regulatory approval for its product candidates, which could delay or prevent commercialization[278]. - The company is subject to extensive and rigorous review and regulation by government authorities, which can prolong the approval process for its product candidates[275]. - The company’s future capital requirements could increase significantly due to various factors, including the costs of clinical trials and commercialization activities[265]. - The company may need to delay, reduce the scope of, or eliminate research or development programs if additional funding is not secured[266]. - The FDA issued a Complete Response Letter (CRL) in August 2020, indicating that the Viaskin Peanut BLA could not be approved in its current form due to concerns about system adhesion impacting efficacy[282]. - A partial clinical hold on the VITESSE trial was imposed by the FDA in September 2022, which was lifted in December 2022 after protocol revisions were made[288]. - Clinical trials are expensive and time-consuming, with potential delays due to various factors including safety demonstrations, patient enrollment, and regulatory approvals[287]. - The company has obtained Fast Track designation from the FDA for Viaskin Peanut and Viaskin Milk, which may allow for a rolling review process[293]. - Regulatory approval processes vary internationally, and failure to obtain such approvals could prevent marketing abroad[296]. - Even with regulatory approval, products may face limitations on marketing and usage, impacting revenue generation[299]. - Post-marketing requirements may impose additional costs and obligations on the company to monitor product safety and efficacy[303]. - The company may face significant penalties for non-compliance with regulatory requirements post-approval[301]. - The FDA's approval does not guarantee approval from foreign regulatory authorities, and vice versa[298]. - Delays in clinical trials could materially harm the commercial prospects of product candidates, affecting revenue generation[289]. Manufacturing and Supply Chain - The company relies on third-party manufacturers for the production of active pharmaceutical ingredients (API) and patches, which may lead to delays in clinical development and commercialization efforts[309]. - The company has only one supplier for the active ingredients used in its Viaskin product candidates, raising concerns about the ability to scale production for commercialization[316]. - The company plans to hire sales representatives for the marketing of Viaskin Peanut in the United States, contingent upon regulatory approval[320]. - The company anticipates that reliance on third-party manufacturers may adversely affect future profit margins and the timely commercialization of products[313]. - The company is diversifying its supply sources to mitigate risks associated with reliance on single suppliers for critical raw materials[308]. - The company has not built commercial-scale manufacturing facilities and has limited manufacturing experience with Viaskin patches, which may impact production capabilities[314]. - The company faces potential delays in commercialization if it fails to achieve announced milestones within expected timeframes[307]. - The company’s business continuity plans may not adequately protect against disruptions caused by natural disasters or outbreaks of contagious diseases[317]. - The company may incur significant costs if it fails to establish effective sales and marketing capabilities or if it relies on third parties for these functions[323]. - The company’s future prospects could be significantly impacted if its product candidates cannot be manufactured in sufficient quantities for commercialization[316]. Competition and Market Dynamics - The Biologics Price Competition and Innovation Act (BPCIA) establishes a 12-year exclusivity period for biological products, with applications not accepted for review until four years after the reference product's first licensure[325]. - The European Union provides eight years of data exclusivity and ten years of market exclusivity for innovative medicinal products, with potential extensions based on new therapeutic indications[328]. - The company believes its product candidates should qualify for the 12-year exclusivity period under BPCIA, but risks exist that this exclusivity could be shortened due to congressional actions[326]. - The company faces substantial competition from larger companies, which may lead to others commercializing products before it does[332]. - Government restrictions on pricing and reimbursement may negatively impact the company's revenue generation if products receive regulatory approval[337]. - The Affordable Care Act (ACA) and subsequent legislation have introduced mandatory reductions in Medicare payments, which could affect the company's market potential[342]. - The company may need to compile additional data for reimbursement in some European countries, as Health Technology Assessment (HTA) processes are becoming more common[346]. - The company is aware of ongoing academic studies and pharmaceutical efforts related to food allergy treatments, which may impact its competitive landscape[334]. - The company acknowledges that even if products are commercialized, acceptance by the medical community is uncertain and could affect market performance[331]. - The company may face challenges in obtaining coverage and reimbursement for newly approved products, which could limit physician usage and adversely affect sales[340]. - The EU Regulation No 2021/2282 on Health Technology Assessment (HTA) will apply from January 2025, allowing EU Member States to use common HTA tools and methodologies[347]. - The financial strain from the COVID-19 pandemic may lead EU legislators to implement cost-containing measures, potentially limiting pricing and reimbursement for new product candidates[348]. - Historical pricing structures in the EU for biopharmaceutical products are generally lower than those in the United States, which may affect future product pricing and market acceptance[350]. - The Viaskin Peanut product's reimbursement and usage may be influenced by guidelines from various organizations, which could adversely affect its market acceptance if recommendations are negative[352]. - Future growth depends on the ability to penetrate foreign markets, which presents additional regulatory and market acceptance risks[356]. - Brexit has introduced uncertainties in the regulatory framework for medicinal products, potentially increasing costs and affecting market access in the UK and EU[361]. Compliance and Legal Risks - Compliance with healthcare laws exposes the company to risks including criminal sanctions and civil penalties, which could impact financial performance[363]. - The company may face reputational risks and penalties for non-compliance with strict laws governing interactions with healthcare professionals in various countries[366]. - Compliance with healthcare laws and regulations may lead to significant civil, criminal, and administrative penalties, potentially disrupting operations[367]. - Changes in regulatory requirements during clinical trials of Viaskin products could increase costs and delay development timelines[368]. - The Physician Payments Sunshine Act mandates manufacturers to report payments to healthcare professionals, impacting transparency and compliance costs[369]. - The EU Clinical Trials Regulation (CTR) became applicable on January 31, 2022, streamlining clinical trial approvals across EU Member States[371]. - The UK may diverge from EU regulations post-2023, potentially affecting clinical trial costs and marketing authorizations[372]. - Collaboration agreements are crucial for product development, with revenues dependent on successful outcomes and regulatory approvals[378]. - The company has scaled down research efforts since 2020, focusing primarily on Viaskin Peanut, with no new clinical trials for other candidates initiated[377]. Intellectual Property - Intellectual property protection is vital for competitive advantage, with risks associated with patent validity and enforcement[384]. - Legal actions to enforce patent rights can be costly and may divert management resources, impacting overall business operations[389]. - Failure to adapt to regulatory changes could adversely affect development plans and market competitiveness[374]. - The patent positions of biopharmaceutical companies are highly uncertain and may be adversely affected by changes in patent laws, which could impact the company's competitive advantage[390]. - The transition to a "first-to-file" system under the America Invents Act may favor larger companies, potentially affecting the company's ability to obtain and enforce patents[395]. - The company may face challenges in protecting its intellectual property rights in foreign jurisdictions, where laws may not provide the same level of protection as in the U.S.[402]. - Enforcement of patent rights in foreign jurisdictions could result in substantial costs and divert the company's focus from other business aspects[403]. - The company may be exposed to future litigation regarding intellectual property rights, which could result in significant damages or hinder product development[412]. - If the company infringes on third-party intellectual property rights, it may face substantial costs, including potential treble damages and the need to obtain licenses[414]. - The company relies on trade secret protection, which is difficult to enforce, and any misappropriation could harm its competitive position[397]. - The company may not seek patent protection in all jurisdictions, leading to potential competition from products developed without patent infringement[400]. - Changes in patent law and legal decisions could adversely affect the company's ability to protect its technology and enforce intellectual property rights[404]. - The company may face claims regarding the ownership of inventions developed in collaboration with third parties, which could limit its ability to capitalize on market potential[405]. Tax and Financial Incentives - The company received a total reimbursement of $26.1 million for the French research tax credit for the fiscal years 2019, 2020, and 2021[428]. - The French research tax credit represented $5.7 million and $7.5 million as of December 31, 2022 and 2021, respectively[428]. - The company is exposed to foreign currency exchange risk, particularly with fluctuations between the euro and the U.S. dollar, which could negatively impact revenue and earnings growth[429]. - The company does not currently engage in hedging transactions to protect against foreign currency exchange rate fluctuations[429]. - The company may face significant costs from class action litigation, which could divert management's attention and resources[425]. - The company maintains liability insurance; however, if litigation costs exceed coverage, it may bear substantial expenses directly[426]. - The company may be subject to legal or administrative proceedings that could materially harm its business and financial condition[427]. - The loss of key personnel could adversely affect the company's ability to achieve its research, development, and commercialization objectives[417]. - The company competes for qualified personnel against larger, more established companies with greater financial resources[418]. - The company may face challenges in maintaining certain tax benefits applicable to French technology companies, which could impact future cash flows[428].

DBV Technologies S.A. (NASDAQ:DBVT) Q3 2022 Earnings Conference Call November 4, 2022 5:00 PM ET Company Participants Anne Pollak – Investor Relations Daniel Tassé – Chief Executive Officer Pharis Mohideen – Chief Medical Officer Conference Call Participants Jon Wolleben – JMP Securities Clément Bassat – Portzamparc Jacob Mekhael – Kempen Matthew Caufield – H.C. Wainwright Arsene Guekam – Kepler Cheuvreux Operator Welcome to the DBV Technologies Third quarter 2022 Earnings Conference Call. My name is Daryl, ...

Financial Performance - Total current assets increased to $225.7 million as of September 30, 2022, compared to $114.4 million as of December 31, 2021, representing a 97.4% increase[19] - Cash and cash equivalents rose to $212.7 million from $77.3 million, marking a 174.5% increase year-over-year[19] - Total liabilities decreased to $36.1 million from $47.4 million, a reduction of 24%[19] - Shareholders' equity increased significantly to $212.1 million from $99.3 million, reflecting a 113.5% growth[19] - The accumulated deficit improved to $(220.3) million from $(258.5) million, indicating a reduction of 14.8%[19] - Operating income for the three months ended September 30, 2022, was $2,074 million, compared to $1,323 million for the same period in 2021, representing a 57% increase[21] - Net loss for the nine months ended September 30, 2022, was $57,033 million, an improvement from a net loss of $84,136 million for the same period in 2021[26] - Total comprehensive loss for the nine months ended September 30, 2022, was $85,520 million, compared to $93,830 million for the same period in 2021, showing a decrease of approximately 8.5%[21] - Net cash flow used in operating activities for the nine months ended September 30, 2022, was $31,781 million, a significant improvement from $89,452 million in the same period of 2021[26] - Financial income for the three months ended September 30, 2022, was $732 million, compared to $336 million in the same period of 2021, marking a 117.5% increase[21] Research and Development - The company is focused on developing the modified Viaskin Peanut patch, with a pivotal Phase III trial named VITESSE initiated on September 9, 2022, for peanut-allergic children ages 4 to 7 years[49] - The FDA placed a partial clinical hold on the VITESSE Phase 3 study, requiring modifications to the protocol before subject recruitment can begin[51] - The company received feedback from the FDA in January 2021, leading to the development of a modified Viaskin Peanut patch and a 6-month safety and adhesion trial named STAMP[44] - The company has outlined a strategy to demonstrate allergen uptake equivalence between the current and modified patches through multiple studies, including EQUAL and PREQUAL[46] - In the pivotal Phase III trial EPITOPE, Viaskin Peanut demonstrated a statistically significant treatment effect with 67.0% of subjects responding positively after 12 months, compared to 33.5% in the placebo group, a difference of 33.4%[56] - The Company plans to further analyze EPITOPE data and explore regulatory pathways for Viaskin Peanut in children aged 1 to 3 years, addressing a high unmet need[57] Strategic Initiatives - The company plans to resubmit a Biologics License Application for Viaskin Peanut to the FDA, with expectations for regulatory approval in the near future[12] - The company is focused on building its sales and marketing capabilities to commercialize Viaskin Peanut upon approval[12] - The company is exploring strategic collaborations to enhance its product development and market reach[12] - The Company withdrew the Marketing Authorization Application for Viaskin Peanut due to insufficient data from a single pivotal study, intending to resubmit once additional data is available[53] Operational Changes - The ongoing COVID-19 pandemic continues to impact operations, research, and development efforts, with potential disruptions noted[12] - The Company has assessed the impact of COVID-19 on its clinical trials, leading to a decrease in new patient enrollments and protocol adaptations[61] - The average number of employees during the nine months ended September 30, 2022, was 85, down from 105 in the same period of 2021[97] - Employee-related costs, excluding share-based payments, decreased by $2.8 million for the nine months ended September 30, 2022, primarily due to workforce reduction[140] Accounting and Compliance - The company has not adopted any new accounting pronouncements in 2022 to date, maintaining its existing accounting policies[41] - The company is currently evaluating the impact of new accounting guidance on its consolidated financial statements, expected to be adopted in 2023[42] Cash Flow and Financing - The Company completed a private investment in public equity (PIPE) financing in June 2022, raising approximately $194 million through the sale of 32,855,669 ordinary shares[59] - Net cash provided by financing activities increased significantly to $194.4 million during the nine months ended September 30, 2022, from $0.1 million in the same period of 2021[168] - The company may seek future financing through public or private equity, debt financings, and collaborations, but faces risks related to economic downturns affecting capital raising[151]

Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share DBVT The Nasdaq Stock Market LLC Ordinary shares, nominal value €0.10 per share* n/a The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quar ...