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DBV Technologies(DBVT) - 2021 Q2 - Earnings Call Transcript
2021-08-02 21:59
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 ...
DBV Technologies(DBVT) - 2021 Q2 - Quarterly Report
2021-08-01 16:00
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 ...
DBV Technologies(DBVT) - 2021 Q1 - Quarterly Report
2021-05-04 16:00
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]
DBV Technologies(DBVT) - 2020 Q4 - Annual Report
2021-03-16 16:00
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(DBVT) - 2020 Q4 - Earnings Call Transcript
2021-03-12 04:37
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 ...
DBV Technologies(DBVT) - 2019 Q4 - Annual Report
2020-03-20 20:12
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 ...
DBV Technologies(DBVT) - 2018 Q4 - Annual Report
2019-04-01 20:35
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 ...