DBV Technologies(US:DBVT)2021-05-04 16:00Financial Performance - Net loss for the three months ended March 31, 2021, was $29,449 thousand, compared to a net loss of $40,913 thousand for the same period in 2020, indicating an improvement of about 28%[21] - Operating income for the three months ended March 31, 2021, was $2,941 thousand for the three months ended March 31, 2021, compared to an operating loss of $4,720 thousand in Q1 2020[21] - Basic/diluted net loss per share attributable to shareholders improved from $(0.79) in Q1 2020 to $(0.54) in Q1 2021[21] - The company experienced a comprehensive loss of $38,279 million for the three months ended March 31, 2021, compared to $46,788 million for the same period in 2020, indicating a decrease of approximately 18.1%[21] - Net loss for the three months ended March 31, 2021, was $29,449 million, compared to a net loss of $40,913 million for the same period in 2020, showing an improvement of 28%[89] Cash Flow and Liquidity - Cash and cash equivalents decreased from $196,352 thousand as of December 31, 2020, to $152,459 thousand as of March 31, 2021, a decline of approximately 22.3%[18] - Net cash flow used in operating activities was $36,204 thousand for the three months ended March 31, 2021, down from $49,683 thousand in the same period of 2020, indicating a 27% reduction in cash outflow[26] - The company expects its current cash balance will be sufficient to fund operations for at least the next 12 months[39] - As of March 31, 2021, total cash and cash equivalents were reported at $152.5 million, down from $196.4 million at December 31, 2020[62] - The company expects current cash and cash equivalents to support operations until the second half of 2022[107] Expenses and Cost Management - Operating expenses decreased from $45,942 thousand in Q1 2020 to $32,575 thousand in Q1 2021, a reduction of approximately 29%[21] - Research and development expenses were $22,164 thousand for the three months ended March 31, 2021, down from $27,532 thousand in the same period of 2020, reflecting a decrease of about 19.6%[21] - Share-based payment expenses were $1,433 thousand for the three months ended March 31, 2021, compared to $3,073 thousand for the same period in 2020, reflecting a 53% decrease[26] - Personnel expenses decreased by $9.7 million, or 51.8%, to $9.0 million during the three months ended March 31, 2021, from $18.7 million for the same period in 2020[94] - Total operating expenses for Q1 2021 were $32.6 million, down 29.1% from $45.9 million in Q1 2020, primarily due to a reduction in personnel expenses[94] Assets and Liabilities - Total assets decreased from $272,246 thousand as of December 31, 2020, to $221,405 thousand as of March 31, 2021, representing a decline of approximately 18.7%[18] - Total current liabilities decreased from $52,713 thousand as of December 31, 2020, to $38,831 thousand as of March 31, 2021, a reduction of about 26.4%[18] - The total shareholders' equity decreased from $205,491 thousand as of December 31, 2020, to $169,176 thousand as of March 31, 2021, a decline of approximately 17.6%[18] - Total liabilities decreased from $66,754 million as of December 31, 2020, to $52,229 million as of March 31, 2021, a reduction of about 21.8%[18] - Restructuring liabilities decreased from $9.4 million on January 1, 2021, to $4.3 million by March 31, 2021[56] Regulatory and Development Updates - The company anticipates the re-submission of a Biologics License Application for Viaskin Peanut to the U.S. FDA, indicating ongoing regulatory efforts[13] - The FDA issued a Complete Response Letter for Viaskin Peanut, citing concerns about patch-site adhesion and the need for modifications[47] - The European Medicines Agency validated the Marketing Authorization Application for Viaskin Peanut, confirming the submission was complete for review[50] - The company plans to submit protocols for safety and adhesion studies to the FDA for the modified Viaskin Peanut patch[86] - The company is advancing its Viaskin technology platform for treating food allergies, with ongoing clinical trials impacted by COVID-19[85] Restructuring and Workforce Changes - The company has initiated a global restructuring plan to provide operational latitude for the clinical development of Viaskin Peanut[39] - The company expects full implementation of the restructuring plan to result in a reduction of more than 200 jobs, leaving a global team of 90 individuals[96] - The Company had an average of 121 employees in Q1 2021, compared to 311 employees in Q1 2020, indicating a significant reduction in headcount[75] - The company expects full implementation of its global restructuring plan, which aims to reduce more than 200 jobs, to be completed by the second half of 2021[96] Clinical Trial Results - 75.9% of patients in the Viaskin Peanut trial increased their eliciting dose from baseline after three years, with 51.8% reaching at least 1,000 mg peanut protein[45] - Treatment compliance in the Viaskin Peanut trial remained high at a mean of 98% over three years[45] - The company observed that 75.9% (107/141) of patients in the Phase III PEPITES trial increased their eliciting dose from baseline after three years[45] - 51.8% (73/141) of patients reached an eliciting dose of at least 1,000 mg peanut protein by year three in the same trial[45] Financing Activities - The global offering raised total gross proceeds of $160.7 million, with net proceeds of $150.0 million after the partial exercise of the underwriters' option[54] - Net cash flow provided by financing activities decreased to $0.4 million in Q1 2021 from $150.6 million in Q1 2020[106] - The company intends to seek additional capital to prepare for the potential launch of Viaskin Peanut, if approved, and to continue other research and development efforts[40]