DBV Technologies publishes its financial results for the first half of 2020 Paris stock exchange: DBV

Montrouge, France, July 31, 2020

DBV Technologies publishes its financial results for the first half of 2020

DBV Technologies (Euronext: DBV ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today published its financial results for the first half of 2020. The interim financial report is available in the Investor Relations section of the site Internet of society, www.dbv-technologies.com/investor-relations/. The financial statements for the first half of 2020 have been subject to a limited review by the company’s external auditors.

In the first half of this year, we focused on working with the FDA and submitting a robust data set to support its review of Viaskin Peanut. We also carried out a restructuring to extend our track and better position our company in order to prepare ourselves to bring this important treatment to patients, said Daniel Tass, CEO of DBV Technologies. Recently, we published encouraging results from the PEOPLE Phase III open label extension study of Viaskin Peanut in The Journal of Allergy and Clinical Immunology, demonstrating the robust and long-term clinical benefit of Viaskin Peanut with a decrease in adverse events in children with peanut allergies. We expect to hear from the FDA on the next steps with our BLA filing shortly and look forward to providing an update at this time.

• Cash position: cash and cash equivalents as at June 30, 2020 amounted to 225.9 million, compared to 172.0 million as at December 31, 2019, an increase of 53.8 million. In the first half of 2020, cash used in operating activities amounted to (79.4) million and cash flow from investing activities to (1.3) million, partially offset by an increase of 134, 2 million cash from financing activities received as part of the February 2020 public company. Offer.
• Operating income: operating profit amounted to 7.6 million in the first half of 2020 compared to 7.1 million in the first half of 2019. In the first half of 2020, as well as in the first half of 2019, the result was mainly generated by the Companys Research Tax Credit ( Crdit dImpt Recherche) and by income recognized under the Companys collaboration agreement with Nestl Health Science.
• Restructuring costs: restructuring costs, linked to the overall restructuring announced on June 26, 2020, amounted to € 19.3 million for the first half of 2020, including accrued charges related to severance payments following planned organizational changes. DBV announced on June 26, 2020 that it is implementing a restructuring plan that will provide the flexibility to continue the BLA review process, prepare to bring Viaskin Peanut to patients, if approved, and preserve the trail companys cash flow. DBV did not have any restructuring costs in the first half of 2019.
• Research and development costs: research and development costs decreased by 3.9 million, or 7.5%, to 48.3 million in the first half of 2020 against 52.2 million in the first half of 2019, reflecting a decrease in personnel costs, including headcount as well as accrued bonuses, retention measures and the share of based compensation costs, within the framework of the announced restructuring plan.
• Sales and marketing costs: Sales and marketing expenses amounted to 6.4 million in the first half of 2020 against 8.3 million in the first half of 2019, reflecting a decrease of 1.9 million, or 23.4%. The decrease in sales and marketing costs is the result of a decrease in personnel costs, including accrued bonuses, retention measures and stock-based compensation expense, as part of the announced restructuring plan. These declines were partially offset by an increase in costs related to marketing tools and services for the potential commercialization of Viaskin Peanut in North America, if approved.
• General and administrative costs: general and administrative expenses amounted to 19.4 million in the first half of 2020 compared to 25.8 million in the first half of 2019, i.e. a decrease of 6.4 million, or 24.8%, resulting from a decrease in accumulated premiums , retention measures and stock compensation expense, as part of the announced restructuring plan. These decreases were partially offset by an increase in consulting and legal fees.
• Net loss: the net loss is (86.5) million for the first half of 2020, against (79.8) million for the first half of 2019. The loss per share (based on the weighted average number of shares outstanding over the period ) is (1.62) and (2.43) in the first half of 2020 and 2019, respectively.

About DBV Technologies
DBV Technologies is developing Viaskin, a proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT, the DBV method for delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to the safe transformation of the care of food allergic patients. DBV’s food allergy programs include ongoing clinical trials with Viaskin Peanut (DBV712). DBV Technologies has its global headquarters in Montrouge, France, and offices in Bagneux, France, and North American operations in Summit, NJ and New York, NY. Companys ordinary shares are traded on the B segment of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and Companys ADS (each representing half of an ordinary share) are traded on the Nasdaq Global Select Market (symbol: DBVT).

Forward-looking statements
This press release may contain forward-looking statements and estimates, including statements regarding the potential of Viaskin Peanut (DBV712) ​​as a treatment for children with peanut allergy and the company’s anticipated interactions with the FDA regarding Viaskin. Peanut and the target action date for companies. BLA. These forward-looking statements and estimates are neither promises nor guarantees and involve significant risks and uncertainties. At this stage, the Company’s products have not been authorized for sale in any country. Factors that could cause actual results to differ materially from those described or projected herein include uncertainties generally associated with research and development, clinical trials and related regulatory reviews and approvals, including the impact of the COVID-19 pandemic. Furthermore, the timing of any FDA action and possible regulatory pathways cannot be guaranteed. A further list and description of these risks, uncertainties and other risks can be found in Companys regulatory documents with the Autorité des Marchs Financiers, Companys Securities and Exchange Commission filings and reports, including in the annual report. of Companys on Form 20-F for the year ended December 31, 2019, as well as future Company filings and reports. Existing and potential investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Except as required by applicable law, DBV Technologies assumes no obligation to update or revise the information contained in this press release.

DBV contact
Sara Blum Sherman
Senior Director, Investor Relations and Strategy
+ 1212-271-0740
[email protected]