On March 3, 2022 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, reported financial results for the full year of 2021 (Press release, DBV Technologies, MAR 3, 2022, View Source [SID1234609506]). The audit procedures have been substantially completed by the Company’s statutory auditors and financials were approved by the Board of Directors on March 3, 2022. The audit report will be issued by the Company’s auditors in March 2022.
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DBV has extended its cash runway into the first quarter of 2023 as a result of continued financial diligence and cost containment measures. These targeted efforts adequately support the critical research and development work underway to advance the Viaskin platform. The protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut ("mVP") patch was completed at the end of February 2022 and has been prepared for FDA submission. The Company is currently engaged in fruitful discussions with FDA in preparation for protocol submission and review. DBV expects to complete protocol submission following further alignment with FDA.
"Initiating our new Phase 3 trial with the mVP is our top priority. We are pleased with our ongoing exchanges with FDA. In parallel to these discussions, DBV continues to maximize the efficiency of its spend. Based on our current assumptions, we have extended our cash runway into the first quarter of 2023," said Daniel Tasse, Chief Executive Officer, DBV Technologies. "We expect that this cash position, combined with our continued discipline to reduce general and administrative expenses without sacrificing research and development, will give DBV sufficient time to gain alignment with FDA on the protocol for the mVP pivotal trial. DBV has been strategic in advancing its EPIT pipeline, and through these efforts, we aim to realize the full potential of the Viaskin technology for patients and families.
As of December 31, 2021, cash and cash equivalents were $77.3 million, compared to $196.4 million as of December 31, 2020. In 2021, cash used in operating activities was $(108.2) million under U.S. GAAP and $(104.1) million under IFRS compared to $(165.6) million under U.S. GAAP and $(160.9) million under IFRS in 2020.
The 35% decrease in net cash used in operating activities between the years ended December 31, 2021 and 2020 reflects the Company’s continued implementation of budget discipline measures.
Over the past 2 years, DBV reduced its net cash used in operating activities by 54%.
Net cash used in operating activities, including restructuring amounts paid as part of the global restructuring plan launched in June 2020 (in millions of $)
Cash flows used in investment activities were $(0.4) million in 2021, compared to $(2.9) million in 2020.
Cash from financing activities were $0.3 million under U.S. GAAP and $(3.9) million under IFRS compared to net cash flows provided by financing activities of $149.5 million under U.S. GAAP and $144.8 million under IFRS in 2020, including $150.0 million received in connection with DBV’s follow-on public offering of its securities in the first quarter of 2020.
DBV has continued to practice financial diligence and implemented further cost containment strategies. Based on its current operations, as well as its plans and assumptions as revised pursuant to its change of strategy announced in December 2021, DBV expects that its current cash and cash equivalents will support its operations into the first quarter of 2023.
Operating Income is 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 income was $5.7 million, for the year ended December 31, 2021, compared to $11.3 million the year ended December 31, 2020. The decrease in operating income is primarily attributable to the revision of the revenue recognized under Nestlé’s collaboration agreement, as the Company updated its measurement of progress of its Phase II clinical study conducted as part of the contract due to recruitments’ delays.
Operating Expenses for the year ended December 31, 2021, were $104.3 million under U.S. GAAP and $104.0 million under IFRS, compared to $170.1 million under U.S. GAAP and $169.2 million under IFRS for the year ended December 31, 2020. The decrease in operating expenses for both periods is mainly attributable to the decrease in external clinical-related expenses and professional fees due to the budget discipline measures taken by DBV, as well as the decrease in employee-related costs, which is directly related to the workforce reduction DBV implemented as part of its 2020 global restructuring plan.
Excluding restructuring and share-based payments expenses, employee-related costs decreased by $19.2 million, from $42.0 million for the year ended December 31, 2020 to $22.7 million for the year ended December 31, 2021, under U.S. GAAP. Under IFRS, excluding share-based payments expenses, employee-related costs decreased by $19.5 million, from $42.3 million for the year ended December 31, 2020 to $22.8 million for the year ended December 31, 2021.
The average headcount decreased by 63% between the two periods, from 270 full-time equivalent employees for the year ended December 31, 2020 to 101 for the year ended December 31, 2021. As of December 31, 2021, DBV had 92 employees.
For the year ended December 31, 2021, net loss was $(97.8) million under U.S. GAAP and $(98.1) million under IFRS, compared to a net loss of $(159.6) million and $(159.7) million, respectively, for the year ended December 31, 2020.
On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(1.78) under U.S. GAAP and $(1.79) under IFRS for the year ended December 31, 2021.
Conference Call Information:
DBV will host a conference call and live audio webcast on Thursday, March 3, 2022, at 5:00 p.m. ET to report fourth quarter and full year 2021 financial results and review recent business updates.
This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50283860
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.