DBV Technologies(DBVT) - 2024 Q2 - Quarterly Results

Q2 and Half-Year 2024 Business and Financial Update Business and Clinical Program Update DBV Technologies provided key updates on its Viaskin Peanut program, with VITESSE Phase 3 study enrollment on track for completion by the end of Q3 2024 and a new labeling proposal submitted to the FDA for the COMFORT Toddlers study - Enrollment for the VITESSE Phase 3 study in peanut-allergic children aged 4-7 is on track to be completed by the end of Q3 2024[2][16] - A labeling proposal was submitted to the FDA for the COMFORT Toddlers study to address protocol queries regarding patch wear-time, based on EPITOPE efficacy data[2][13] - The company ended Q2 2024 with a cash balance of $66.2 million, and its cash runway is extended into Q1 2025 due to cost-saving measures[2][5] VITESSE Phase 3 Study Update Enrollment for the VITESSE Phase 3 pivotal study, evaluating the modified Viaskin® Peanut patch in approximately 600 children aged 4-7 with peanut allergies, is progressing as planned, with the final subject expected to be screened by the end of Q3 2024 across 86 sites globally - The VITESSE trial is evaluating the efficacy and safety of the modified Viaskin® Peanut patch in approximately 600 subjects aged 4-7, randomized 2:1[16] - Recruitment is expected to be complete by the end of Q3 2024, with strong momentum from engagement at medical conferences and patient advocacy outreach[2][30] COMFORT Toddlers Study and FDA Engagement DBV proposed a new labeling approach to the FDA for the Viaskin Peanut patch in toddlers (1-3 years) on June 28th, using a 90-day period to identify patient response likelihood and guide treatment continuation, and is awaiting the FDA's response - DBV submitted a draft labeling proposal to the FDA on June 28th, focusing on dosing and administration to address patch wear-time concerns[2][24] - The proposed approach identifies "Label-in" and "Label-out" patient populations within the first 90 days of treatment based on their patch wear-time experience to predict clinical efficacy[43] - DBV has noted increased engagement from the FDA and looks forward to continued dialogue to advance the regulatory pathway for Viaskin Peanut in toddlers[4] Financial Highlights For the first half of 2024, DBV reported a net loss of $60.5 million due to increased operating expenses, ending Q2 with $66.2 million in cash, raising substantial doubt about its ability to continue as a going concern without additional financing Condensed Consolidated Statements of Operations (U.S. GAAP, in millions of USD) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Revenues | 2.6 | 4.5 | 1.2 | 2.3 | | Operating expenses | (65.0) | (50.7) | (35.0) | (27.4) | | Net loss | (60.5) | (44.8) | (33.1) | (24.2) | | Basic/diluted net loss per share | (0.63) | (0.48) | (0.34) | (0.26) | Operating Income Operating income for the first six months of 2024 decreased by $1.9 million to $2.6 million, primarily due to a lower Research Tax credit entitlement as more study activities were conducted in North America Operating Income Comparison (H1, U.S. GAAP, in millions of USD) | Period | 2024 | 2023 | | :--- | :--- | :--- | | Six months ended June 30 | $2.6 | $4.5 | Operating Expenses Operating expenses for H1 2024 increased by $14.3 million to $65.0 million, primarily driven by higher Research & Development costs for clinical trials and a $3.1 million rise in employee-related costs due to a headcount increase of 24 - Operating expenses increased by $14.3 million in H1 2024 vs H1 2023, mainly from higher R&D costs for the VITESSE and COMFORT clinical trials[7] - Employee-related costs rose by $3.1 million in H1 2024 due to a headcount expansion of 24 employees to support clinical, regulatory, and quality activities[49] Operating Expenses Breakdown (H1, U.S. GAAP, in millions of USD) | Expense Category | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Research & Development | (46.8) | (33.7) | | Sales & Marketing | (1.7) | (0.9) | | General & Administrative | (16.4) | (16.1) | | Total Operating Expenses | (65.0) | (50.7) | Net Loss The company's net loss for the first six months of 2024 widened to $60.5 million, or $(0.63) per share, from $44.8 million, or $(0.48) per share, in the same period of 2023 Net Loss and EPS Comparison (H1, U.S. GAAP) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net Loss (in millions USD) | $(60.5) | $(44.8) | | Net Loss Per Share (USD) | $(0.63) | $(0.48) | Cash Position, Runway, and Going Concern DBV ended Q2 2024 with $66.2 million in cash, a decrease from $141.4 million at year-end 2023, extending its cash runway into Q1 2025 but raising substantial doubt about its ability to continue as a going concern without additional financing - Cash and cash equivalents were $66.2 million as of June 30, 2024, compared to $141.4 million as of December 31, 2023[46] - The company's cash runway is expected to last into Q1 2025 due to cost-saving measures[5] - There is substantial doubt regarding the company's ability to continue as a going concern, as available cash is not projected to be sufficient for the next 12 months[34] - The company plans to seek additional capital to fund its R&D efforts and prepare for the potential launch of Viaskin Peanut[27] Corporate Information and Disclosures DBV Technologies is a clinical-stage biopharmaceutical company developing food allergy treatments using its Viaskin platform, with shares traded on Euronext Paris and Nasdaq, and the release includes standard forward-looking statements about inherent risks Company Overview DBV Technologies is a clinical-stage biopharmaceutical company developing food allergy treatments using its proprietary Viaskin platform for epicutaneous immunotherapy (EPIT), headquartered in France with U.S. operations and dual-listed shares - DBV is a clinical-stage biopharmaceutical company developing treatments for food allergies using its proprietary Viaskin platform, which is based on epicutaneous immunotherapy (EPIT)[40] - The company is headquartered in France with North American operations in New Jersey, and its shares are dual-listed on Euronext Paris and the Nasdaq[11] Forward-Looking Statements The press release contains forward-looking statements regarding DBV's financial condition, product potential, and clinical/regulatory efforts, which are subject to substantial risks and uncertainties, advising investors to consult SEC filings - The release includes forward-looking statements on financial condition, cash runway, product potential, and clinical/regulatory timing[41] - These statements involve significant risks related to R&D, clinical trials, and regulatory approvals, and investors are cautioned not to place undue reliance on them[41]