On March 11, 2021 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the year ended December 31, 2020 (Press release, DBV Technologies, MAR 11, 2021, View Source [SID1234576735]). The financials have been audited by the Company’s statutory auditors and were approved by the Board of Directors on March 11, 2021. The audit report will be issued by the Company’s auditors in March 2021.
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"DBV ended 2020 well positioned to advance Viaskin Peanut towards potential approval in both the United States and European Union," said Daniel Tasse, Chief Executive Officer of DBV Technologies. "We remain focused on advancing our strategic objectives in 2021 and beyond as we continue to work towards improving the lives of patients with food allergies."
Recent Business Developments
Viaskin Peanut US: DBV has commenced a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches in order to identify the best one or two performing patches. All trial participants are expected to complete the trial by the end of March.
DBV plans to advance those patches selected for use in the protein transport study (EQUAL) and adhesion and safety study (STAMP) that will be discussed with the FDA.
Viaskin Peanut EU: DBV received the European Medicines Agency (EMA) Day 120 questions which are consistent with both DBV’s expectations and pre-filing conversations with the EMA. DBV did not receive questions about the impact of adhesion on efficacy.
Full-Year 2020 Financial Highlights1
Cash & Cash Equivalents: cash and cash equivalents as of December 31, 2020 were $196.4 million, compared to $193.3 million as of December 31, 2019. In 2020, cash used in operating activities was $(165.6) million under U.S. GAAP and $(160.9) million under IFRS and cash flows used in investment activities were $(2.9) million. Cash from financing activities were $149.5 million under U.S. GAAP and $144.8 million under IFRS, including $150.0 million received in connection with DBV’s follow-on public offering of its securities in the first quarter of 2020. Based on its current assumptions, DBV expects that its current cash and cash equivalents, will support its operations until the second half of 2022.
Operating Income: operating income was $11.3 million in 2020, compared to $14.7 million in 2019, a decrease of 23.3%. In both 2020 and 2019, operating income was primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science.
Operating Expenses: operating expenses for the year ended December 31, 2020, were $170.1 million under U.S. GAAP and $168.9 million under IFRS, compared to $185.7 million under U.S. GAAP and $185.1 million under IFRS for the year ended December 31, 2019. Excluding restructuring costs discussed below, operating expenses for the year ended December 31, 2020 were $146.6 million under U.S. GAAP and $145.9 million under IFRS. The overall decrease in operating expenses, excluding restructuring costs, was primarily due to the budget discipline measures taken by DBV, in particular the decrease in personnel expenses, which is directly related to the workforce reduction DBV implemented during its global restructuring plan. As a result of the ongoing COVID-19 pandemic, DBV also experienced decrease in other expenses, in particular tradeshows and travel expenses.
Restructuring Costs: restructuring costs, related to DBV’s global restructuring plan announced on June 26, 2020, were $23.6 million under U.S. GAAP and $23.0 million under IFRS for the year ended December 31, 2020, which costs include severance-related expenses, restructuring-related consulting and legal fees and expenses related to impairment of facilities and rights of use assets. DBV expects that the global restructuring plan, which includes significant headcount reductions that DBV anticipates completing by the end of the first quarter of 2021, will result in a remaining global team of 90 individuals. DBV had no restructuring costs in 2019.
Net Loss: Under U.S. GAAP net loss was $(159.6) million for the year ended December 31, 2020, compared to $(172.0) million for the year ended December 31, 2019. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(2.95) and $(4.65) for the years ended December 31, 2020 and 2019, respectively. Under IFRS, net loss was $(159.4) and $(172.5) million for the years ended December 31, 2020 and 2019, respectively, and net loss per share was $(2.95) and $(4.66) for the years ended December 31, 2020 and 2019, respectively.
DBV will host a conference call and live audio webcast on Thursday, March 11, 2021, at 5:00 p.m. ET/11:00 p.m. CET to discuss financial results for the year ended December 31, 2020 and to provide a general corporate update on the status of Viaskin Peanut in the US and EU.
This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50114481.
A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event.