Medincell (MDCLF) Q2 2021 Earnings Call

Investor webinar replay

Replay transcript excerpt

Hello, everyone. Welcome to this video conference dedicated to the presentation of our half-yearly results, meaning the period from April 1 to September 30, 2021. Today, we published two documents after the close of the stock market. Firstly, a press release with a summary of our financials for this period. Secondly, an extended report that you can download on our website. This conference will last 45 minutes maximum. You can send your question by using the chat module to the right of your screen. You can also like the questions so that they are given higher priority. For this meeting, I'm in Paris with Christophe Douac, CEO of Making Cell. Hello, Christophe. Hello, David. Hi to all. And Remy Arambo, our chief financial officer. Hello, Remy. Hello, David. Hello, everyone. Joël Richard, our Chief Development Officer, is joining us live from our headquarters in Montpellier. Hello, Richard. Hello, Loël, sorry. Hello, everybody. So, we will start with an update of our portfolio of products based on our long-acting injectable technology, BIPO. The main event is obviously the progress of our most advanced product, NDC-IRM, a program developed with TIVA we have two major announcements in the past months. First, the acceptance of the NDA, the new drug application, which is the request for marketing authorization. It was accepted for review by the FDA in August. Christophe, would you like to make a comment on why this is so significant for Medincel? Thank you David. Yes, indeed. It is a fundamental event for the company. If we take into account the usual delays, since the filing was accepted by the FDA in August, the approval should happen before summer 2022. TEVA confirmed that commercialization should start in 2022 as well, of course, subject to the approval from the FDA. A...