On October 26, 2021 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the third quarter of 2021 (Press release, DBV Technologies, OCT 26, 2021, View Source [SID1234591952]). The quarterly financial statements were approved by the Board of Directors on October 26, 2021. The Company also provided regulatory updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Viaskin Peanut.
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US Regulatory Update:
On October 14, 2021, DBV received communication from the FDA concerning the STAMP protocol submission of May 6, 2021. The FDA has requested a stepwise approach to DBV’s modified Viaskin Peanut (mVP) development program. The FDA would like to review the data from DBV’s protein uptake release study prior to providing additional comments on the STAMP protocol design.
In its communication, FDA stated that guidance is forthcoming on how best to demonstrate the protein uptake comparability of the mVP to the reference or current patch (cVP).
The STAMP trial will not be initiated until DBV receives complete feedback from the FDA.
"DBV is working hard to find an efficient and timely path forward. On behalf of patients and providers urgently awaiting a therapeutic advancement in treating peanut allergy, DBV will continue to pursue our goal of bringing Viaskin Peanut to the food allergy community," said Daniel Tasse, Chief Executive Officer, DBV Technologies.
EU Regulatory Update:
The EMA review of the Viaskin Peanut Marketing Authorization Application is progressing according to established EMA processes and ongoing conversations with the EMA. DBV is preparing its responses to the Day 180 letter and evaluating how to best address the Objections, including the remaining Major Objection which questions the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study. Further exchanges with EMA are anticipated. DBV estimates the EMA could issue its decision on potential marketing authorization for Viaskin Peanut in 1Q 2022.
Financial Highlights for the Third Quarter Ended September 30, 20211
As of September 30, 2021, cash and cash equivalents were $98.2 million, compared to $196.4 million as of December 31, 2020 and $125.5 million as of June 30, 2021. The $98.2 million decrease in cash position during the first nine months of 2021, consisting of $43.9 million, $27.0 million, and $27.3 million in the first, second and third quarter of 2021, respectively, was mostly comprised of $89.5 million of net cash used in operating activities and the effect of exchange rates on cash and cash equivalents for $(8.6) million.
The 32% decrease in net cash used in operating activities between the first nine months of 2020 and 2021 reflects the Company’s continued implementation of cost containment measures and the decrease in personnel expenses related to the workforce reduction as part of the Company’s global restructuring plan. Based on its current assumptions, DBV expects that its current cash and cash equivalents will support its operations into the third quarter of 2022.
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 $1.3 million and $2.8 million, for the three and nine months ended September 30, 2021, respectively, compared to $4.2 million and $12.5 million for the three and nine months ended September 30, 2020, respectively. 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 delays in new patient enrollment.
Operating Expenses for the three months ended September 30, 2021, were $(25.7) million, compared to $(33.9) million for the three months ended September 30, 2020. For the nine months ended September 30, 2021, operating expenses were $(87.9) million, compared to $(131.2) million for the nine months ended September 30, 2020, or a decrease of 33%. 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 $13.8 million, from $32.9 million for the nine months ended September 30, 2020 to $19.1 million for the nine months ended September 30, 2021, a 42% decrease, compared to a 64% decrease of the average number of headcounts between the two periods (105 and 291 full-time equivalent employees for the nine months ended September 30, 2021 and 2020 respectively). As of September 30, 2021, DBV had 92 employees.
For the three and nine months ended September 30, 2021, net loss was $(24.0) million and $(84.1) million, respectively, compared to a net loss of $(31.0) million and $(120.1) million, respectively, for the comparable periods in 2020.
On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(0.44) and $(1.53) for the three and nine months ended September 30, 2021, respectively.
Conference Call Information:
DBV will host a conference call and live audio webcast on Tuesday, October 26, 2021, at 5:00 p.m. ET to report third quarter 2021 financial results and provide a corporate update.
This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50247411
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.