DBV Technologies(DBVT)

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DBV Technologies(DBVT) - 2023 Q3 - Quarterly Report
2023-10-30 16:00
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]
DBV Technologies(DBVT) - 2023 Q2 - Earnings Call Transcript
2023-08-01 00:02
DBV Technologies S.A. (NASDAQ:DBVT) Q2 2023 Earnings Call July 31, 2023 5:00 PM ET Company Participants Katie Matthews - Head of Investor Relations Daniel Tassé - Chief Executive Officer Sébastien Robitaille - Chief Financial Officer Pharis Mohideen - Chief Medical Officer Conference Call Participants Jon Wolleben - JMP Securities Operator Good afternoon, and welcome to the DBV Technologies Second Quarter Financial Results Conference Call. My name is Vaishnavi, and I am the operator for this call. At this t ...
DBV Technologies(DBVT) - 2023 Q2 - Quarterly Report
2023-07-30 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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) France Not applicable State or other ju ...
DBV Technologies(DBVT) - 2023 Q1 - Quarterly Report
2023-05-03 16:00
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(DBVT) - 2022 Q4 - Earnings Call Transcript
2023-03-04 00:13
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 ...
DBV Technologies(DBVT) - 2022 Q4 - Annual Report
2023-03-01 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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) | France | | Not applicable | | ...
DBV Technologies(DBVT) - 2022 Q3 - Earnings Call Transcript
2022-11-06 19:52
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, ...
DBV Technologies(DBVT) - 2022 Q3 - Quarterly Report
2022-11-02 16:00
Table of Contents DBVT 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 quarterly period ended September 30, 2022 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 ...
DBV Technologies(DBVT) - 2022 Q2 - Quarterly Report
2022-07-31 16:00
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(DBVT) - 2022 Q1 - Earnings Call Transcript
2022-05-02 22:33
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 ...