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].

DBV Technologies S.A. (NASDAQ:DBVT) Q2 2021 Earnings Conference Call August 2, 2021 5:00 PM ET Company Participants Anne Pollak - Head of Investor Relations Daniel Tassé - Chief Executive Officer Sébastien Robitaille - Chief Financial Officer Conference Call Participants Graig Suvannavejh - Goldman Sachs Jon Wolleben - JMP Securities Operator Good afternoon, and welcome to the DBV Technologies First Half 2021 Financial Results and Business Update Conference Call. My name is Reece, and I am the operator for ...

Table of Contents Title of each class Trading 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 qua ...

Financial Performance - Net loss for the three months ended March 31, 2021, was $29,449 thousand, compared to a net loss of $40,913 thousand for the same period in 2020, indicating an improvement of about 28%[21] - Operating income for the three months ended March 31, 2021, was $2,941 thousand for the three months ended March 31, 2021, compared to an operating loss of $4,720 thousand in Q1 2020[21] - Basic/diluted net loss per share attributable to shareholders improved from $(0.79) in Q1 2020 to $(0.54) in Q1 2021[21] - The company experienced a comprehensive loss of $38,279 million for the three months ended March 31, 2021, compared to $46,788 million for the same period in 2020, indicating a decrease of approximately 18.1%[21] - Net loss for the three months ended March 31, 2021, was $29,449 million, compared to a net loss of $40,913 million for the same period in 2020, showing an improvement of 28%[89] Cash Flow and Liquidity - Cash and cash equivalents decreased from $196,352 thousand as of December 31, 2020, to $152,459 thousand as of March 31, 2021, a decline of approximately 22.3%[18] - Net cash flow used in operating activities was $36,204 thousand for the three months ended March 31, 2021, down from $49,683 thousand in the same period of 2020, indicating a 27% reduction in cash outflow[26] - The company expects its current cash balance will be sufficient to fund operations for at least the next 12 months[39] - As of March 31, 2021, total cash and cash equivalents were reported at $152.5 million, down from $196.4 million at December 31, 2020[62] - The company expects current cash and cash equivalents to support operations until the second half of 2022[107] Expenses and Cost Management - Operating expenses decreased from $45,942 thousand in Q1 2020 to $32,575 thousand in Q1 2021, a reduction of approximately 29%[21] - Research and development expenses were $22,164 thousand for the three months ended March 31, 2021, down from $27,532 thousand in the same period of 2020, reflecting a decrease of about 19.6%[21] - Share-based payment expenses were $1,433 thousand for the three months ended March 31, 2021, compared to $3,073 thousand for the same period in 2020, reflecting a 53% decrease[26] - Personnel expenses decreased by $9.7 million, or 51.8%, to $9.0 million during the three months ended March 31, 2021, from $18.7 million for the same period in 2020[94] - Total operating expenses for Q1 2021 were $32.6 million, down 29.1% from $45.9 million in Q1 2020, primarily due to a reduction in personnel expenses[94] Assets and Liabilities - Total assets decreased from $272,246 thousand as of December 31, 2020, to $221,405 thousand as of March 31, 2021, representing a decline of approximately 18.7%[18] - Total current liabilities decreased from $52,713 thousand as of December 31, 2020, to $38,831 thousand as of March 31, 2021, a reduction of about 26.4%[18] - The total shareholders' equity decreased from $205,491 thousand as of December 31, 2020, to $169,176 thousand as of March 31, 2021, a decline of approximately 17.6%[18] - Total liabilities decreased from $66,754 million as of December 31, 2020, to $52,229 million as of March 31, 2021, a reduction of about 21.8%[18] - Restructuring liabilities decreased from $9.4 million on January 1, 2021, to $4.3 million by March 31, 2021[56] Regulatory and Development Updates - The company anticipates the re-submission of a Biologics License Application for Viaskin Peanut to the U.S. FDA, indicating ongoing regulatory efforts[13] - The FDA issued a Complete Response Letter for Viaskin Peanut, citing concerns about patch-site adhesion and the need for modifications[47] - The European Medicines Agency validated the Marketing Authorization Application for Viaskin Peanut, confirming the submission was complete for review[50] - The company plans to submit protocols for safety and adhesion studies to the FDA for the modified Viaskin Peanut patch[86] - The company is advancing its Viaskin technology platform for treating food allergies, with ongoing clinical trials impacted by COVID-19[85] Restructuring and Workforce Changes - The company has initiated a global restructuring plan to provide operational latitude for the clinical development of Viaskin Peanut[39] - The company expects full implementation of the restructuring plan to result in a reduction of more than 200 jobs, leaving a global team of 90 individuals[96] - The Company had an average of 121 employees in Q1 2021, compared to 311 employees in Q1 2020, indicating a significant reduction in headcount[75] - The company expects full implementation of its global restructuring plan, which aims to reduce more than 200 jobs, to be completed by the second half of 2021[96] Clinical Trial Results - 75.9% of patients in the Viaskin Peanut trial increased their eliciting dose from baseline after three years, with 51.8% reaching at least 1,000 mg peanut protein[45] - Treatment compliance in the Viaskin Peanut trial remained high at a mean of 98% over three years[45] - The company observed that 75.9% (107/141) of patients in the Phase III PEPITES trial increased their eliciting dose from baseline after three years[45] - 51.8% (73/141) of patients reached an eliciting dose of at least 1,000 mg peanut protein by year three in the same trial[45] Financing Activities - The global offering raised total gross proceeds of $160.7 million, with net proceeds of $150.0 million after the partial exercise of the underwriters' option[54] - Net cash flow provided by financing activities decreased to $0.4 million in Q1 2021 from $150.6 million in Q1 2020[106] - The company intends to seek additional capital to prepare for the potential launch of Viaskin Peanut, if approved, and to continue other research and development efforts[40]

Financial Performance - The company has incurred net losses of $172.0 million and $159.6 million for the years ended December 31, 2019 and 2020 respectively, with an accumulated deficit of $958.5 million as of December 31, 2020[198]. - The company expects to continue incurring significant operating losses and anticipates that current cash will fund operations only until the second half of 2022[210]. - The company anticipates requiring additional financing to continue funding operations, with capital needs influenced by clinical trial costs and regulatory approvals[230]. Cash and Funding - As of December 31, 2020, the company's cash and cash equivalents were $196.4 million, primarily funded through equity financings and public assistance[205]. - The company plans to seek substantial additional capital in the future to commercialize Viaskin Peanut and develop other product candidates[211]. - The company may face challenges in raising additional share capital due to French law limitations on capital increases without shareholder approval[215]. Product Development and Regulatory Approval - The company has not generated any product revenue to date and continues to advance the clinical and regulatory development of Viaskin Peanut in the United States and European Union[200]. - The Marketing Authorization Application (MAA) for Viaskin Peanut has been validated by the European Medicines Agency (EMA), confirming the submission is complete for review[208]. - The FDA has raised concerns regarding the efficacy of Viaskin Peanut related to patch-site adhesion, requiring modifications and additional studies[206]. - The FDA issued a Complete Response Letter for the Viaskin Peanut Biologics License Application, citing concerns about patch-site adhesion and the need for modifications[245]. - The company plans to submit protocols for safety and adhesion studies to the FDA in Q2 2021, following feedback indicating a defined regulatory path forward[246]. - The company is currently advancing product candidates through pre-clinical and clinical development, with expected increases in research and development expenses[204]. - The company is dependent on obtaining FDA approval for its Viaskin products before marketing them in the United States, which is a complex and uncertain process[251]. - The company must demonstrate the safety and efficacy of its product candidates through extensive clinical testing, which is inherently uncertain[268]. Clinical Trials and Challenges - Clinical trials are expensive and time-consuming, with a high risk of failure, potentially leading to increased costs and delays in product development[253]. - The company has experienced delays in obtaining FDA approval for Viaskin Peanut and may face further delays in the future[269]. - The ongoing COVID-19 pandemic has caused disruptions that may affect the company's operations, including clinical trials and access to capital[218]. - The ongoing COVID-19 pandemic may disrupt operations and supply chains, affecting the company's ability to conduct clinical trials and commercialize products[303]. Market and Competitive Landscape - The biopharmaceutical industry is highly competitive, with established competitors having greater resources and experience, which may hinder the company's ability to succeed[321]. - Market acceptance of the company's products is uncertain and will depend on factors such as clinical efficacy, safety, and pricing relative to competitors[319]. - Government restrictions on pricing and reimbursement could negatively impact the company's revenue generation if products are approved for marketing[325]. Regulatory Compliance and Risks - The company faces significant legal and compliance costs as a U.S. public company, which may strain resources and divert management's attention[237]. - The company is subject to extensive regulatory review and must demonstrate safety and efficacy for product candidates, a process that can take many years[250]. - Any failure to comply with regulatory requirements could result in significant penalties or restrictions on product marketing[281]. - The company faces significant regulatory compliance costs and risks associated with healthcare laws, which could disrupt operations[350]. Intellectual Property and Legal Risks - The ability to protect proprietary rights through patents is uncertain, with various factors potentially affecting patentability and enforcement[366]. - Legal actions to enforce patent rights can be costly and may not guarantee successful outcomes, impacting the company's competitive position[370]. - The company may need to resort to litigation to enforce its patents or protect trade secrets, which could be costly and time-consuming[391]. - There is a risk of litigation regarding trade secret misappropriation or other claims related to prior affiliations of employees or consultants, which could consume managerial and financial resources[394]. Supply Chain and Manufacturing - The company is dependent on a single supplier, Sanofi S.A., for active pharmaceutical ingredients, which poses risks to the supply chain and commercialization efforts[291]. - The company has only manufactured Viaskin product candidates at a scale sufficient for research and clinical trials, with no assurance that these processes will be adequate for commercial needs[298]. - The company intends to diversify supply sources for critical raw materials to mitigate risks associated with reliance on single suppliers[290]. Sales and Marketing - The company currently lacks a commercial-ready marketing and sales infrastructure, which may hinder effective sales and marketing of product candidates if approved[309]. - Plans are in place to hire sales representatives for the marketing of Viaskin Peanut in the United States, contingent on approval, but establishing a sales force is costly and time-consuming[310]. - The company faces risks in recruiting and retaining effective sales and marketing personnel, which could impact the commercialization of its product candidates[311].

DBV Technologies S.A. (NASDAQ:DBVT) Q4 2020 Earnings Conference Call March 11, 2021 5:00 PM ET Company Participants Anne Pollak - Head of Investor Relations Daniel Tassé - Chief Executive Officer & Director Pascal Wotling - Chief Technical Operations Officer Pharis Mohideen - Chief Medical Officer Sébastien Robitaille - Chief Financial Officer Conference Call Participants Alex Cogut - Kempen Graig Suvannavejh - Goldman Sachs Jon Wolleben - JMP Securities Operator Good afternoon, and welcome to the DBV Techn ...

Table of Contents DBVT The Nasdaq Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHEL ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECT ...