DBV Technologies(DBVT) - 2024 Q4 - Annual Results

FDA Approval and Product Development - The FDA has agreed that safety exposure data from the VITESSE Phase 3 study is sufficient to support a Biologics License Application (BLA) for the Viaskin peanut patch in children aged 4-7, eliminating the need for the COMFORT Children supplemental safety study[1] - The BLA submission for the Viaskin peanut patch is now expected in the first half of 2026, potentially accelerating the product launch by approximately one year if approved by the FDA[2] - The VITESSE study enrolled 654 participants, making it the largest Phase 3 clinical trial for peanut allergy in this age group, with over 500 participants expected to be included in the safety database at the time of BLA submission[4] - The COMFORT Toddlers study is expected to initiate in the second quarter of 2025, with a BLA submission for the 1-3 year old indication anticipated in the second half of 2026[5] - The company is focused on developing its proprietary VIASKIN® patch technology for food allergies, with ongoing clinical trials for VIASKIN Peanut targeting peanut allergic toddlers and children[26] - DBV Technologies is committed to transforming the care of food allergic individuals through its epicutaneous immunotherapy (EPIT™) approach[26] Financial Performance - Cash and cash equivalents decreased to $32.5 million as of December 31, 2024, from$141.4 million as of December 31, 2023, reflecting a net cash consumption of $108.9 million primarily due to clinical trial-related expenses[10] - Operating income for the year ended December 31, 2024, was$4.2 million, down from $15.7 million in 2023, a decrease of$11.5 million attributed to the termination of a collaboration agreement and lower research tax credits[15] - Operating expenses increased to $120.7 million for the year ended December 31, 2024, compared to$92.2 million in 2023, driven by a $29.1 million rise in research and development costs[17] - The company recorded a net loss of$113.9 million for the year ended December 31, 2024, compared to a net loss of $72.7 million for the same period in 2023, resulting in a net loss per share of$(1.17)[20] - For the year ended December 31, 2024, the net loss was $113.9 million, compared to a net loss of$72.7 million in 2023, representing a 56.7% increase in losses year-over-year[23] - Operating income decreased to $4.2 million in 2024 from$15.7 million in 2023, indicating a decline of 73.3%[23] - Research and Development expenses rose to $89.3 million in 2024, up from$60.2 million in 2023, reflecting a 48.3% increase[23] - Net cash flows used in operating activities were $(104.5) million in 2024, compared to$(79.7) million in 2023, representing a 31.1% increase in cash outflow[24] - The net cash and cash equivalents at the end of the period decreased to $32.5 million in 2024 from$141.4 million in 2023, a decline of 77.0%[24] Capital and Audit Status - The company has incurred operating losses and negative cash flows from operations since inception, with available cash expected to fund operations only into April 2025[11] - The company intends to seek additional capital to support ongoing research and development efforts and the BLA filing for the Viaskin peanut patch[12] - The company has not yet obtained assurance from its auditors that the financial statements will be certified without qualification, indicating ongoing audit procedures[25] Company Overview - DBV Technologies is headquartered in Châtillon, France, with operations in North America located in Warren, NJ[27] - The company's ordinary shares are traded on Euronext Paris and its ADSs on the Nasdaq Capital Market, indicating its presence in both European and U.S. markets[27]