DBV Technologies(US:DBVT)2023-07-30 16:00Financial Performance - The company reported a net loss of $24.2 million for the three months ended June 30, 2023, compared to a net loss of $23.0 million for the same period in 2022, indicating an increase in loss of about 5.3%[22] - Net loss for the six months ended June 30, 2023, was $44.804 million, compared to a net loss of $39.746 million for the same period in 2022, representing an increase of approximately 12.9%[25] - Basic/diluted net loss per share attributable to shareholders was $0.26 for the three months ended June 30, 2023, compared to $0.35 for the same period in 2022, indicating a decrease in loss per share of about 25.7%[22] - Total comprehensive loss for the six months ended June 30, 2023, was $41.5 million, compared to $52.8 million for the same period in 2022, reflecting a decrease of about 21.4%[22] - Net loss for the three months ended June 30, 2023, was $24.2 million, compared to a net loss of $23.0 million in the same period of 2022, with net loss per share improving from $(0.35) to $(0.26)[116] Assets and Liabilities - As of June 30, 2023, total assets decreased to $217.5 million from $246.5 million as of December 31, 2022, representing a decline of approximately 11.7%[18] - Total current liabilities increased to $33.4 million as of June 30, 2023, from $29.5 million as of December 31, 2022, marking an increase of about 13.1%[18] - Cash and cash equivalents decreased to $174.0 million as of June 30, 2023, from $209.2 million as of December 31, 2022, a decline of approximately 16.4%[18] - Total current assets decreased from $223,074 thousand as of December 31, 2022, to $195,539 thousand as of June 30, 2023, a decline of approximately 12.4%[18] - The company’s total shareholders' equity as of June 30, 2023, was $164.240 million, a decrease from $244.416 million at the end of June 30, 2022[29] Research and Development - Research and development expenses for the six months ended June 30, 2023, were $33.7 million, up from $30.8 million in the same period of 2022, reflecting an increase of approximately 9.4%[22] - The company is focused on developing a modified Viaskin Peanut patch, with ongoing studies to assess safety and efficacy, including the STAMP study[40] - The company is focused on building its sales and marketing capabilities to commercialize Viaskin Peanut and other product candidates, if approved[14] - The company is advancing regulatory efforts for VP in toddlers aged 1-3 years with confirmed peanut allergy following positive clinical trial results[99] - The company plans to conduct a new safety study for Viaskin Peanut in children aged 1-3 years, following FDA confirmation that the EPITOPE study met the pre-specified criteria for success[51][57] Clinical Trials and Regulatory Milestones - The company anticipates the re-submission of a Biologics License Application for Viaskin™ Peanut to the FDA, which is a key future milestone[14] - The FDA lifted a partial clinical hold on the VITESSE study on December 23, 2022, allowing the trial to proceed with a revised protocol[48] - The first patient was screened in the VITESSE study on March 7, 2023, with the last patient screening anticipated in the first half of 2024 and topline results expected in the first half of 2025[50][61] - The FDA confirmed that the Phase 3 EPITOPE study for Viaskin Peanut meets the pre-specified criteria for success, requiring additional safety data for a BLA submission[98] - The company has completed enrollment for Part B of the EPITOPE study, which included 362 subjects aged 1-3 years, with 244 in the active arm and 118 in the placebo arm[56] Expenses and Cash Flow - Net cash flow used in operating activities for the six months ended June 30, 2023, was $(46.394) million, significantly higher than $(11.733) million for the same period in 2022[25] - General and administrative expenses increased by $3.5 million to $9.2 million for the three months ended June 30, 2023, mainly due to one-time costs associated with financing activities and market research[112] - Sales and marketing expenses decreased by $0.6 million (37%) to $950 million for the six months ended June 30, 2023, primarily due to reductions in external professional services and employee-related costs[125][126] - The company reported a significant increase in expenses related to share-based payments, totaling $3.446 million for the six months ended June 30, 2023, compared to $2.441 million in the same period of 2022, an increase of approximately 41.2%[25] - Net cash used in operating activities increased by $34.7 million (295%) to $46.4 million for the six months ended June 30, 2023, primarily due to the repayment of research tax credit receivable[145] Shareholder Information - The total number of ordinary shares increased from 94,137,145 on January 1, 2023, to 96,250,954 by June 30, 2023, due to the issuance of new shares[29] - The company raised $7.8 million through the issuance of new ordinary shares in June 2023 under the At-The-Market program[62] - The company has not incurred any bank debt and has relied on financing activities to support operations[133] - The company intends to seek additional capital for the launch of Viaskin Peanut and ongoing research and development efforts[134] - The company granted 59,200 stock options and 35,800 restricted stock units to employees during the six months ended June 30, 2023[77]