DBV Technologies(DBVT) - 2024 Q3 - Quarterly Report

Financial Performance - Operating income for the three months ended September 30, 2024, was €1,072,000, down from €2,372,000 for the same period in 2023, representing a decrease of approximately 54.8%[11] - Net loss for the nine months ended September 30, 2024, was €90,903,000, compared to a net loss of €61,540,000 for the same period in 2023, reflecting an increase in loss of approximately 47.6%[13] - Total comprehensive loss for the nine months ended September 30, 2024, was €91,138,000, compared to €62,111,000 for the same period in 2023, an increase of approximately 46.9%[11] - Basic/diluted net loss per share attributable to shareholders for the three months ended September 30, 2024, was €0.32, compared to €0.17 for the same period in 2023, indicating a worsening of 88.2%[11] - Net loss for Q3 2024 was $30,442 million, an increase of 81.9% from a net loss of $16,736 million in Q3 2023[77] - Net loss increased to $90.9 million for the nine months ended September 30, 2024, compared to a net loss of $61.5 million for the same period in 2023, resulting in a net loss per share of $0.95[98] Assets and Liabilities - Total current assets decreased from €158,915,000 on December 31, 2023, to €68,759,000 on September 30, 2024, a decline of approximately 56.7%[7] - Total liabilities decreased from €42,799,000 on December 31, 2023, to €39,021,000 on September 30, 2024, a reduction of about 8.5%[8] - Total shareholders' equity dropped from €140,187,000 on December 31, 2023, to €54,034,000 on September 30, 2024, a decrease of approximately 61.5%[9] - Cash and cash equivalents decreased significantly from €141,367,000 at the beginning of the period to €46,441,000 at the end of the period, a decline of about 67.1%[13] - The company reported a total shareholders' equity of $54.034 million, down from $79.095 million as of June 30, 2024, reflecting a net loss of $30.442 million for the quarter[16] Research and Development - Research and development expenses increased to €23,662,000 for the three months ended September 30, 2024, compared to €13,795,000 for the same period in 2023, an increase of about 71.5%[11] - The company is preparing for the potential launch of its first product, Viaskin Peanut, in the U.S. and EU, pending regulatory approval[21] - The company initiated the VITESSE Phase 3 pivotal study for the modified Viaskin Peanut patch in children aged 4-7 years, with topline results anticipated by the fourth quarter of 2025[25] - The Company plans to enroll approximately 300-350 subjects in the COMFORT Toddlers safety study, bringing the total safety database for the Viaskin Peanut patch in toddlers to approximately 600 subjects[37] - The Company submitted the protocol for the COMFORT Children supplemental safety study for ages 4-7 years to the FDA, expecting to enroll around 250 subjects, raising the total to approximately 600 in this age group[30] Cash Flow and Financing - The company reported a net cash flow used in operating activities of €92,222,000 for the nine months ended September 30, 2024, compared to €65,967,000 for the same period in 2023, reflecting an increase in cash outflow of about 39.8%[13] - The company plans to seek additional capital to support its research and development efforts and the launch of Viaskin Peanut, which may involve debt and equity offerings[21] - The company has established an At-The-Market program to raise up to $100 million through the sale of American Depositary Shares[101] - The net cash flow from financing activities decreased to $(0.1) million for the nine months ended September 30, 2024, compared to $7.0 million in the same period of 2023[109] Regulatory and Compliance - The company received a Complete Response Letter from the FDA in August 2020 regarding the Viaskin Peanut BLA, necessitating patch modifications and additional clinical data[25] - The Company announced positive regulatory updates for the Viaskin Peanut patch in the U.S. and Europe, with guidance from the FDA on a potential pathway under the Accelerated Approval Program for toddlers aged 1-3 years[35] - The Company has been engaged in ongoing dialogue with the FDA regarding the COMFORT Toddlers supplemental safety study for children aged 1-3 years with peanut allergies[26] - The Company intends to resubmit the Marketing Authorization Application (MAA) for Viaskin Peanut once the necessary data set is available[32] Operational Expenses - Total operating expenses increased by 52.1% to $31,401 million in Q3 2024 from $20,642 million in Q3 2023[77] - Total operating expenses for the nine months ended September 30, 2024, were $96.37 million, an increase of 35.0% compared to $71.37 million in 2023[88] - General and administrative expenses increased by $1.04 million to $7.22 million for the three months ended September 30, 2024, a 16.8% increase from $6.18 million in 2023[83] - Personnel expenses increased to $8,331 million in Q3 2024 from $6,724 million in Q3 2023, a rise of 24%[63] Other Financial Metrics - The estimated research tax credit for the first nine months of the 2024 fiscal year amounts to $3,640 thousand, compared to $4,978 thousand for the same period in 2023[61] - Research tax credit decreased by $1.34 million to $3.64 million for the nine months ended September 30, 2024, a 26.9% decrease from $4.98 million in 2023[89] - Financial income decreased to $1.9 million for the nine months ended September 30, 2024, down from $3.0 million in the same period of 2023[96] Management and Governance - The report was signed by Daniel Tassé, Chief Executive Officer, and Virginie Boucinha, Chief Financial Officer, on November 6, 2024[124]