DBV Technologies S.A.

Good afternoon and welcome to the DBV Technologies Full Year 2020 Financial Results and Business Updates Conference Call. At this time, all participants are in listen-only mode. Following the formal remarks, we'll open up the call for your questions. Please advise this call is being recorded and the company's request. At this time, I'd like to call on Ann Pollack, Head of Investor Relations. Ann, please proceed.

Thank you, Operator. This afternoon, DBV Technologies issued a press release that outlines our financial results for the full year ending December 31, 2020. This release is available in the press release section of the DBV Technologies website. Before we begin, please note that today's call may include a number of forward-looking statements, including but not limited to comments regarding our clinical development plans, our anticipated future interactions with regulatory agencies, and our financial forecasts. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company's filings with the SEC and the French AMF for information concerning risk factors that could cause the company's actual results to differ materially from expectations. including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. Joining me on today's call are Daniel Tassé, Chief Executive Officer of DBV, Sebastian Robitaille, Chief Financial Officer, Pascal Wotling, Chief Technical Operations Officer and Pharis Mohideen, Chief Medical Officer. We had originally scheduled this call for last Thursday and then decided to shift it to today. I would like to provide some context on the date change. This is our first financial reporting period for DBV as a U.S. domestic filer. We will now file our financial results in U.S. dollars according to both U.S. GAAP and IFRS and in both English and French. As you can imagine, it is an enormous amount of work coordinated among internal and external teams in both the U.S. and France. We decided to take one additional week to confirm all requirements were met. It is now my pleasure to hand the call over to Daniel. Daniel?

And thank you, and thank you all for joining us this evening. So in 2021 at DDV, our highest priority is advancing via skin peanut in both the United States and in the European Union. We are committed to its potential approval as a treatment for children ages 4 to 11 who suffer from peanut allergy. And we are making important progress on both fronts. First, let me provide you an update on the European Union side. In the fourth quarter of last year, the European Medicines Agency, or EMA, validated our marketing authorization application for Bias Cane Peanuts and began their review process. We recently received a day 120 questions from the EMA review team. The list of questions is consistent with what we were expecting to receive at this stage of the review cycle and are aligned to our pre-filing conversations with the EMA. Of note, we did not receive any questions about the impact of adhesion on efficacy or a request for patch modification. Now turning to the U.S. side. Since receiving a complete response letter from the Food and Drug Administration from the FDA in August, we have made significant progress on modifying our patch. As a reminder, the CRL outlined the agency's concerns regarding the impact of patch adhesion as it relates to efficacy and indicated the need for patch modifications. The FDA agreed that the modified patch would not be a new product entity, if we met their data requirements. Our manufacturing process was engineered with the long-term potential of the whole Biaskin technology platform in mind, so it has the flexibility to produce multiple types of patches. I will turn the call over to Pascal Wotling, our Chief Technical Operations Officer, who is leading the past manufacturing engineering and to Pharis Mohideen, our chief medical officer who is leading obviously clinical development regulatory to provide you more information on the patch modification process. Now we are planning to evaluate one or two modified patches in children ages four to 11 who suffer from peanut allergies. Pascal, let's start with you.