On August 2, 2021 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the second quarter of 2021 (Press release, DBV Technologies, AUG 2, 2021, View Source [SID1234585532]). The quarterly financial statements were approved by the Board of Directors on July 30, 2021.
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"DBV has continued to prioritize the advancement of Viaskin Peanut’s regulatory dossier. In 2Q 2021, we have made significant progress in developing and selecting modified Viaskin Peanut patches," said Daniel Tasse, Chief Executive Officer, DBV Technologies. "The two final modified patches demonstrate stronger adhesion as compared to the current system while preserving the structure of the occlusion chamber. Further, DBV advanced our clinical study efforts. We initiated a Phase I study intended to support EQUAL and submitted the STAMP study protocol to the FDA. In parallel, DBV has remained diligent about spend and I am confident that our cash on hand as of June 30, 2021 will support our operations until the second half of 2022."
Recent Business Developments
Viaskin Peanut US:
In 2Q 2021, DBV completed CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches in order to identify the top performers. Based on the adhesion parameters studied, DBV was pleased to learn that all modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the current Viaskin Peanut patch. DBV then selected two modified patches that performed best out of the five modified patches studied for further development.
The difference between the two selected patches is their shape—one is circular and the other is rectangular with rounded corners. They are both approximately 50% larger than the current patch but maintain the same structure of the occlusion chamber (i.e., foam ring and backing). DBV also conducted advisory boards with patient caregivers and key opinion leaders to obtain qualitative feedback on the consumer experience with both patches.
DBV submitted the protocol for STAMP (Safety, Tolerability and Adhesion of Modified Patches), the 6-month adhesion and safety study of the modified patch, to the FDA in 2Q 2021 and is currently awaiting feedback.
Earlier this quarter, DBV initiated PREQUAL, a Phase 1 study in healthy adult volunteers to optimize the allergen sample collection methodologies and validate the assays DBV intends to use in EQUAL (EQuivalence in the Uptake of ALlergen). DBV continues to work closely with FDA on how to best demonstrate the protein transport comparability of the modified patch (mVP) to the reference patch (cVP).
Viaskin Peanut EU:
DBV received from the EMA Day 180 list of outstanding issues. The review of the Viaskin Peanut Marketing Authorization Application (MAA) is progressing according to established EMA processes and ongoing conversations with the EMA.
Many of EMA’s Objections and Major Objections have been answered; One Major Objection remains. DBV will provide a response to address the outstanding issues, including the mentioned Major Objection.
Based on the average length of an EMA evaluation of an MAA, DBV estimates the EMA could issue its decision on potential marketing authorization for Viaskin Peanut in the fourth quarter of 2021 or the first quarter of 2022.
Class Action Complaint:
As previously disclosed, a class action complaint was filed in January 2019 in the U.S. District Court, District of New Jersey, alleging that the Company and certain current and former executive officers violated certain U.S. federal securities laws. On July 29, 2021, immediately after a hearing, the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. The Court indicated that the Second Amended Complaint was deficient in a number of ways and granted Plaintiffs until September 30 to amend the complaint to try to cure the deficiencies.
Financial Highlights for the Second Quarter and the 6 Months Ended June 30, 20211
Cash and Cash Equivalents as of June 30, 2021 were $125.5 million, compared to $196.4 million as of December 31, 2020 and $152.5 million as of March 31, 2021. The net decreases of respectively $27.0 million and $70.9 million for the quarter and six months ended June 30, 2021 were primarily due to cash used in operating activities and the effect of exchange rates on cash and cash equivalents. Excluding restructuring amounts paid of $6.3 million in the first half of 2021, the cash used in operating activities amounts to $(60.2) million under U.S. GAAP and $(57.8) million under IFRS, reflecting the Company’s continued implementation of budget discipline measures. 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 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 $(1.5) million for the quarter ended June 30, 2021 and $1.5 million for the six months ended June 30, 2021, compared to $3.6 million and $8.3 million respectively for the three months ended and six months ended June 30, 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 three months ended June 30, 2021, were $(29.6) million, compared to $(51.3) million for the three months ended June 30, 2020, each under U.S. GAAP. For the six months ended June 30, 2021, operating expenses were $(62.2) million under U.S. GAAP and $(62.0) million under IFRS, compared to $(97.2) million and $(96.9) million under U.S GAAP and IFRS, respectively, for the six months ended June 30, 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 share-based payments expenses, employee-related costs decreased by $9.7 million, from $23.1 million for the six months ended June 30, 2020 to $13.4 million for the six months ended June 30, 2021, a 42% decrease, compared to a 64% decrease of the average number of headcounts between the two periods (111 and 311 full-time equivalent employees for the six months ended June 30, 2021 and 2020 respectively). As of June 30, 2021, DBV had 97 employees.
Net loss was $(30.7) million for the three months ended June 30, 2021, compared to $(48.2) million for the three months ended June 30, 2020.
Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.56) and $(0.88) for the three months ended June 30, 2021 and 2020, respectively.
For the six months ended June 30, 2021, net loss was $(60.1) million and $(60.2) million under U.S. GAAP and IFRS, respectively. Net loss per share was $(1.09) under U.S. GAAP and $(1.10) IFRS.
DBV will host a conference call and live audio webcast on Monday, August 2, 2021, at 5:00 p.m. ET to report second quarter 2021 financial results and provide a corporate update.
This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50184237.
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.