DBV Technologies(US:DBVT)2022-05-01 16:00Financial Performance - Net loss for the three months ended March 31, 2022, was $16,706 thousand, compared to a net loss of $29,449 thousand for the same period in 2021, indicating a reduction in losses of about 43.3%[18] - Total comprehensive loss for the three months ended March 31, 2022, was $18,615 thousand, down from $38,279 thousand in Q1 2021, indicating a decrease of approximately 51.4%[18] - Basic/diluted net loss per share attributable to shareholders improved from $(0.54) in Q1 2021 to $(0.30) in Q1 2022[18] - Net loss for the period was $16.706 million for the three months ended March 31, 2022, compared to a net loss of $29.449 million for the same period in 2021[22] - Total operating expenses decreased from $32,575 thousand in Q1 2021 to $19,317 thousand in Q1 2022, reflecting a decrease of about 40.5%[18] Assets and Liabilities - Total assets decreased from $146,723 thousand as of December 31, 2021, to $117,581 thousand as of March 31, 2022, representing a decline of approximately 19.9%[16] - Total liabilities decreased from $47,449 thousand as of December 31, 2021, to $35,519 thousand as of March 31, 2022, representing a decrease of about 25.1%[16] - Cash and cash equivalents decreased from $77,301 thousand as of December 31, 2021, to $74,107 thousand as of March 31, 2022, a decline of approximately 2.8%[16] - The company’s accumulated deficit increased from $258,528 thousand as of December 31, 2021, to $275,219 thousand as of March 31, 2022[16] - The Company reported a significant decrease in other current assets, totaling $16.329 million as of March 31, 2022, down from $37.085 million as of December 31, 2021[61] Cash Flow and Financing - Net cash flow used in operating activities was $1.483 million for the three months ended March 31, 2022, significantly reduced from $36.204 million in the same period of the previous year[22] - The company expects its cash and cash equivalents will be sufficient to fund operations into the first quarter of 2023[40] - The company plans to seek additional capital to prepare for the new pivotal study and potential launch of Viaskin Peanut, if approved[41] - The company intends to finance future cash needs through a combination of public or private equity or debt financings, collaborations, and other forms of non-dilutive financings[41] - The company has incurred operating losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[38] Research and Development - Research and development expenses decreased from $22,164 thousand in Q1 2021 to $12,223 thousand in Q1 2022, a reduction of approximately 44.9%[18] - The company has received a Complete Response Letter from the FDA regarding its Biologics License Application for Viaskin Peanut, prompting a focus on generating additional clinical data[35] - The company has initiated a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch in children ages 4-11, with the protocol submitted to the FDA in April 2022[52] - The Company plans to resubmit the Marketing Authorization Application for Viaskin Peanut in the EU once data from a second pivotal study is available[53] - The company is focused on building its sales and marketing capabilities to commercialize Viaskin Peanut and other product candidates, if approved[11] Operational Changes - The company implemented a global restructuring plan to focus on the clinical development and regulatory review of Viaskin Peanut, completed in the second half of 2021[35] - The Company has experienced a decrease in new patient enrollments in ongoing clinical studies due to the COVID-19 pandemic, necessitating protocol adaptations[55] - The average number of employees decreased to 88 during the three months ended March 31, 2022, compared to 121 in the same period of 2021[79] - Total personnel expenses for the three months ended March 31, 2022, were $5.915 million, a decrease from $9.002 million in the same period of 2021[80] - The company recognized an income of $1.2 million due to the early termination of its U.S. office lease, offset by a one-time termination fee of $1.5 million[65] Legal and Compliance - The Company believes that the allegations in the class action complaint filed against it are without merit and will continue to defend the case vigorously[59] - The Company has not adopted any new accounting pronouncements in 2022 to date, and does not expect future accounting standards to have a material impact on its financial statements[44][46] - The Company is currently evaluating the impact of new accounting guidance on its consolidated financial statements, but does not expect it to be material[45] Lease and Contingencies - As of March 31, 2022, total minimum lease payments amounted to $4.666 billion, a decrease from $11.684 billion as of December 31, 2021[65] - Total contingencies decreased to $9.288 million as of March 31, 2022, from $10.853 million as of December 31, 2021[74] - Operating cash flows from operating leases were $583 million for the period ending March 31, 2022, down from $1.025 billion in the same period of 2021[66] - The company had a weighted average remaining lease term of 2.21 years and a weighted average discount rate of 3.51% as of March 31, 2022[65] - Deferred income from the collaboration agreement with Nestlé Health Science amounted to $3.8 million as of March 31, 2022[70]