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 ...

DBV Technologies S.A. (NASDAQ:DBVT) Q1 2022 Results Conference Call May 2, 2022 5:00 PM ET Company Participants Anne Pollak - Head, IR Daniel Tassé - CEO Conference Call Participants Jon Wolleben - JMP Securities Operator Welcome to the DBV Technologies First Quarter 2022 Earnings Conference Call. My name is Daryl and I will be your operator for today’s call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] As a reminder, t ...

Financial Performance - Net loss for the three months ended March 31, 2022, was $16,706 thousand, compared to a net loss of $29,449 thousand for the same period in 2021, indicating a reduction in losses of about 43.3%[18] - Total comprehensive loss for the three months ended March 31, 2022, was $18,615 thousand, down from $38,279 thousand in Q1 2021, indicating a decrease of approximately 51.4%[18] - Basic/diluted net loss per share attributable to shareholders improved from $(0.54) in Q1 2021 to $(0.30) in Q1 2022[18] - Net loss for the period was $16.706 million for the three months ended March 31, 2022, compared to a net loss of $29.449 million for the same period in 2021[22] - Total operating expenses decreased from $32,575 thousand in Q1 2021 to $19,317 thousand in Q1 2022, reflecting a decrease of about 40.5%[18] Assets and Liabilities - Total assets decreased from $146,723 thousand as of December 31, 2021, to $117,581 thousand as of March 31, 2022, representing a decline of approximately 19.9%[16] - Total liabilities decreased from $47,449 thousand as of December 31, 2021, to $35,519 thousand as of March 31, 2022, representing a decrease of about 25.1%[16] - Cash and cash equivalents decreased from $77,301 thousand as of December 31, 2021, to $74,107 thousand as of March 31, 2022, a decline of approximately 2.8%[16] - The company’s accumulated deficit increased from $258,528 thousand as of December 31, 2021, to $275,219 thousand as of March 31, 2022[16] - The Company reported a significant decrease in other current assets, totaling $16.329 million as of March 31, 2022, down from $37.085 million as of December 31, 2021[61] Cash Flow and Financing - Net cash flow used in operating activities was $1.483 million for the three months ended March 31, 2022, significantly reduced from $36.204 million in the same period of the previous year[22] - The company expects its cash and cash equivalents will be sufficient to fund operations into the first quarter of 2023[40] - The company plans to seek additional capital to prepare for the new pivotal study and potential launch of Viaskin Peanut, if approved[41] - The company intends to finance future cash needs through a combination of public or private equity or debt financings, collaborations, and other forms of non-dilutive financings[41] - The company has incurred operating losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[38] Research and Development - Research and development expenses decreased from $22,164 thousand in Q1 2021 to $12,223 thousand in Q1 2022, a reduction of approximately 44.9%[18] - The company has received a Complete Response Letter from the FDA regarding its Biologics License Application for Viaskin Peanut, prompting a focus on generating additional clinical data[35] - The company has initiated a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch in children ages 4-11, with the protocol submitted to the FDA in April 2022[52] - The Company plans to resubmit the Marketing Authorization Application for Viaskin Peanut in the EU once data from a second pivotal study is available[53] - The company is focused on building its sales and marketing capabilities to commercialize Viaskin Peanut and other product candidates, if approved[11] Operational Changes - The company implemented a global restructuring plan to focus on the clinical development and regulatory review of Viaskin Peanut, completed in the second half of 2021[35] - The Company has experienced a decrease in new patient enrollments in ongoing clinical studies due to the COVID-19 pandemic, necessitating protocol adaptations[55] - The average number of employees decreased to 88 during the three months ended March 31, 2022, compared to 121 in the same period of 2021[79] - Total personnel expenses for the three months ended March 31, 2022, were $5.915 million, a decrease from $9.002 million in the same period of 2021[80] - The company recognized an income of $1.2 million due to the early termination of its U.S. office lease, offset by a one-time termination fee of $1.5 million[65] Legal and Compliance - The Company believes that the allegations in the class action complaint filed against it are without merit and will continue to defend the case vigorously[59] - The Company has not adopted any new accounting pronouncements in 2022 to date, and does not expect future accounting standards to have a material impact on its financial statements[44][46] - The Company is currently evaluating the impact of new accounting guidance on its consolidated financial statements, but does not expect it to be material[45] Lease and Contingencies - As of March 31, 2022, total minimum lease payments amounted to $4.666 billion, a decrease from $11.684 billion as of December 31, 2021[65] - Total contingencies decreased to $9.288 million as of March 31, 2022, from $10.853 million as of December 31, 2021[74] - Operating cash flows from operating leases were $583 million for the period ending March 31, 2022, down from $1.025 billion in the same period of 2021[66] - The company had a weighted average remaining lease term of 2.21 years and a weighted average discount rate of 3.51% as of March 31, 2022[65] - Deferred income from the collaboration agreement with Nestlé Health Science amounted to $3.8 million as of March 31, 2022[70]

Financial Performance and Funding - The company has incurred net losses of $97.8 million and $159.6 million for the years ended December 31, 2021, and 2020, respectively, with an accumulated deficit of $258.5 million as of December 31, 2021[201]. - As of December 31, 2021, the company's cash and cash equivalents were $77.3 million, which is expected to fund operations into the first quarter of 2023[212]. - The company plans to seek additional capital through public or private equity or debt financings, collaborations, and other forms of non-dilutive financing to support its operations and product development efforts[207]. - The company expects operating losses to continue for the foreseeable future, with research and development expenses anticipated to increase substantially as it seeks regulatory approval for Viaskin Peanut[211]. - The company anticipates needing additional financing to fund operations, with capital requirements dependent on various factors including clinical trial costs and regulatory approvals[231]. - Future cash needs are expected to be met through a combination of equity or debt financings, collaborations, and other non-dilutive financing methods[232]. - The company may need to scale back operations if it cannot secure sufficient funding, which could adversely affect its business and financial condition[218]. - The company is limited in its ability to raise additional share capital under French law, which may complicate future fundraising efforts[219]. Product Development and Regulatory Approval - The company has not generated any product revenue to date and continues to prepare for the potential launch of Viaskin Peanut in the United States and European Union, pending regulatory approval[212]. - Future revenues will depend on the successful development, regulatory approval, and commercialization of Viaskin Peanut, with significant expenses anticipated for these activities[204]. - Discussions with the FDA are ongoing for the Phase III pivotal study of the modified Viaskin Peanut patch, which requires additional clinical development and regulatory approval[243]. - The company’s product candidates are subject to extensive regulatory review, and any setbacks in obtaining approvals could materially affect business prospects[245]. - 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 patch-site adhesion affecting efficacy[250]. - The company has experienced setbacks in obtaining FDA approval for Viaskin Peanut, with no assurance that future product candidates will receive approval[263]. - Fast track designation has been obtained from the FDA for Viaskin Peanut and Viaskin Milk, but this does not guarantee a faster development or approval process[264]. - The company must ensure compliance with FDA regulations throughout the product development and marketing process to avoid penalties and maintain market access[271]. Clinical Trials and Development Risks - Clinical trials are time-consuming and expensive, with a high risk of failure, which could lead to delays or elimination of product development programs[246]. - The ongoing COVID-19 pandemic has impacted clinical trial operations, potentially delaying patient enrollment and site activation, which could affect the company's development timelines[224]. - Clinical trials are expensive and time-consuming, with potential delays due to various factors including safety and efficacy demonstrations, patient enrollment, and regulatory approvals[255]. - Third-party performance failures in clinical trials may increase development costs and delay regulatory approval[286]. - The company has conducted over 10 clinical trials for Viaskin Peanut and Viaskin Milk, involving more than 1,000 human patients to evaluate safety and efficacy[316]. - Adverse events in clinical trials primarily involved skin and immune system disorders, with one reported case of mild to moderate anaphylaxis[316]. Market and Competitive Landscape - The biopharmaceutical industry is highly competitive, with numerous companies and research entities involved in developing therapeutic options for food allergies, posing a risk to the company's product candidates[299]. - The company faces risks related to the acceptance of its products by the medical community, which could impact market success[297]. - Regulatory approval processes for biological products may lead to competition sooner than anticipated, affecting market exclusivity[294]. - Government restrictions on pricing and reimbursement may negatively impact the company's ability to generate revenues if products are approved[304]. - Third-party payors are increasingly reducing reimbursements for medical products, which could adversely affect sales and financial condition[305]. Intellectual Property and Legal Risks - The company faces risks related to intellectual property, including potential challenges to its patents and the need to maintain a robust patent portfolio, which entails significant expenses[334]. - The patent positions of biopharmaceutical companies are highly uncertain and may be adversely affected by changes in patent laws, which could impact competitive advantage and revenue potential[339]. - Litigation regarding intellectual property rights is common in the biopharmaceutical industry, and any adverse outcomes could result in significant financial liabilities[355]. - The company may need to seek licenses for third-party patents, which could be costly and may not be available on commercially acceptable terms[362]. - If the company infringes on third-party intellectual property rights, it may face delays in product development and increased commercialization costs[358]. Compliance and Regulatory Challenges - The company is required to maintain effective internal controls over financial reporting, and any identified material weaknesses could adversely affect investor confidence and share value[227]. - The company must ensure compliance with healthcare laws to avoid significant civil, criminal, and administrative penalties, which could disrupt operations[325]. - The company is subject to various healthcare laws and regulations that could expose it to significant penalties, including civil and criminal sanctions, which may adversely affect profits and future earnings[322]. - The company faces additional regulatory burdens and risks when penetrating foreign markets, including compliance with complex foreign regulations and potential reimbursement issues[320]. Data Privacy and Cybersecurity - The company is subject to stringent data privacy and security obligations, including compliance with laws like HIPAA and the California Consumer Privacy Act, which could lead to fines of up to $7,500 per violation[384]. - The company may incur significant expenses to enhance personal data processing capabilities in foreign jurisdictions if compliance mechanisms are not established[388]. - Non-compliance with data privacy obligations could lead to government enforcement actions, including investigations and penalties, adversely affecting the company's reputation and financial condition[390]. - Cyberattacks and ransomware threats are increasing, posing risks to the company's operations and sensitive information, potentially leading to significant disruptions and financial losses[396]. - The company relies on third-party service providers for critical business systems, which may expose it to vulnerabilities if those providers do not have adequate security measures[394].

Financial Data and Key Metrics Changes - As of December 31, 2021, cash and cash equivalents were $77.3 million, which is expected to support operations into the first quarter of 2023 [14] - Cash used in operating activities in the second half of 2021 was $41.7 million, representing a 54% decrease compared to the first half of 2020 [16] Business Line Data and Key Metrics Changes - The company is focused on the clinical regulatory development of the modified Viaskin Peanut patch, with a pivotal Phase 3 clinical study planned for initiation [9][10] - The company has successfully completed the pivotal trial protocol and is preparing for submission to the FDA [10][17] Market Data and Key Metrics Changes - The company acknowledges that its current stock price does not reflect the significant potential of the Viaskin platform, particularly Viaskin Peanut [21] Company Strategy and Development Direction - The company aims to balance extending its cash runway while preserving critical research and development efforts [12][13] - DBV Technologies is exploring various financing options, including non-dilutive strategies, to support its operations and development plans [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing discussions with the FDA regarding the pivotal trial protocol, indicating a positive engagement [11][25] - The company is excited about the potential of the EPITOPE study, which is expected to report results mid-year [26] Other Important Information - The company has exceeded its goal of reducing average monthly cash burn by 40% to 50% in the second half of 2021 compared to the first half of 2020 [15] Q&A Session Summary Question: Can you provide more details on the interactions with the FDA regarding the protocol? - Management indicated that discussions with the FDA have been productive, focusing on the core principles of the study, and they are pleased with the progress made [23][25] Question: When is the protocol expected to be submitted, and what are the next steps? - The protocol is ready for submission, and management expects to send it in short order after finalizing discussions with the FDA [25] Question: Can you provide an update on the EPITOPE program? - The EPITOPE study is due to report results mid-year, and management is looking forward to the outcomes [26] Question: What are the internal expectations for the EPITOPE study and its implications for younger children? - Management emphasized the importance of the one to three-year-old demographic and stated that they would reserve judgment on the data until it is available [27]

Financial Performance - Operating income for Q3 2021 was $1.3 million, a decrease of 68% from $4.2 million in Q3 2020[67]. - Net loss for Q3 2021 was $24.0 million, a 22% improvement from a net loss of $31.0 million in Q3 2020[66]. - Operating income for the nine months ended September 30, 2021, was $2.776 million, a decrease of $9.713 million (78%) compared to $12.488 million in the same period in 2020[76]. - Net loss was $84.1 million for the nine months ended September 30, 2021, an improvement from a net loss of $120.1 million for the same period in 2020, resulting in a net loss per share of $1.53[86]. - Financial income was $0.3 million for the three months ended September 30, 2021, compared to a financial expense of $1.2 million in the same period in 2020, indicating a positive shift in financial performance[72]. - Financial income was $0.6 million for the nine months ended September 30, 2021, compared to a financial expense of $1.4 million for the same period in 2020[84]. - The company recorded an income tax profit of $0.4 million for the nine months ended September 30, 2021, primarily due to US tax refunds[85]. Expenses - Research and development expenses decreased by 37% to $16.3 million in Q3 2021 from $25.8 million in Q3 2020[66]. - Total operating expenses decreased by 24% to $25.7 million in Q3 2021 compared to $33.9 million in Q3 2020[66]. - Sales and marketing expenses amounted to $1.1 million for the three months ended September 30, 2021, a decrease of $524,000 (33%) compared to $1.6 million in the same period in 2020, mainly due to reduced employee-related costs[69]. - General and administrative expenses increased by $1.4 million (21%) for the three months ended September 30, 2021, compared to the same period in 2020, driven by higher external professional services and employee-related costs[70]. - Total research and development expenses for the nine months ended September 30, 2021, were $58.7 million, a decrease of $16.6 million (22%) compared to $75.2 million in the same period in 2020[78]. - Sales and marketing expenses for the nine months ended September 30, 2021, were $2.999 million, down $5.1 million (63%) from $8.114 million in the same period in 2020, primarily due to workforce reductions[81]. - Employee-related costs in research and development decreased by $8.3 million (44%) for the nine months ended September 30, 2021, compared to the same period in 2020, due to workforce reductions[79]. - External clinical-related expenses decreased by $3.2 million (9%) for the nine months ended September 30, 2021, compared to the same period in 2020, as a result of cost containment measures[78]. - General and administrative expenses decreased by $0.6 million, or 2%, to $26.25 million for the nine months ended September 30, 2021, compared to $26.84 million for the same period in 2020[82]. Cash Flow and Liquidity - Net cash flow used in operating activities decreased by $42.6 million, or 32%, to $89.5 million for the nine months ended September 30, 2021, compared to $132.1 million for the same period in 2020[89]. - Cash and cash equivalents decreased to $98.2 million as of September 30, 2021, down from $221.4 million on September 30, 2020[92]. - The company expects its current cash and cash equivalents will support operations into the third quarter of 2022, but there is substantial doubt regarding the ability to continue as a going concern[94]. - The company did not incur any restructuring costs for the nine months ended September 30, 2021, following a global restructuring plan initiated in June 2020[83]. - The company has not incurred any bank debt and has not entered into any off-balance sheet arrangements[93][98]. Research and Development - The company completed the CHAMP trial in Q2 2021, demonstrating improved adhesion performance of modified Viaskin Peanut patches compared to the current patch[62]. - The FDA has requested a 6-month well-controlled adhesion trial for the modified Viaskin Peanut patch, which will not be initiated until feedback is received[62]. - The company is preparing responses to the EMA's Day 180 letter regarding the Viaskin Peanut MAA, with a potential decision expected in Q1 2022[63]. - The company generated $1.6 million from the French research tax credit in Q3 2021, a decrease of 9% from $1.8 million in Q3 2020[67]. - The company has selected two modified patches for further development based on their performance in the CHAMP trial[62]. - The company is advancing its Viaskin technology to treat food allergies, focusing on safety for infants and children[62]. - Research and development expenses decreased by $9.4 million (37%) for the three months ended September 30, 2021, compared to the same period in 2020, primarily due to a decrease in depreciation, amortization, and employee-related costs[68].