Egetis Therapeutics AB (publ) (EGTX) Q1 2026 Earnings Call

Investor webinar replay

Replay transcript excerpt

Welcome to Agedis Therapeutics Q1 Report 2026. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key 5 on their telephone keypad. If you are listening to the presentation via webcast, you can ask written questions using the form below. Now I will hand the conference over to CEO Nicholas Westerholm. Please go ahead. Good morning, and a warm welcome to our quarter one results plan for the coming 30 minutes. For those who haven't had the privilege to meet before, my name is Nick Rousseff, and I'm the CEO of the company. With me today, we also have Yilmaz Mashi, Chief Financial Officer, Henrik Lund, Vice President, Commercial Operations, Annie Bedard, President of our U.S. business, and Karl Hahn, Vice President and Head of Investor Relations. Let's turn our attention to the topics covered today, depicted on the slide in front of you. To summarize, Quarter 1 has been historical for EGTIS, with several key milestones delivered. Amongst others, and most importantly, the FDA acceptance of our new drug application for the treatment of MCTA deficiency. Where the Agency also granted us a priority review, with a so-called PDUFA target action date, i.e. decision date, set to September 28, 2026. We will also provide an update on the launch preparations in the U.S., as well as the commercialization in the European Union. And furthermore, a financial update will be covered by our CFO. And we aim to leave ample time for Q&A at the end of the session. So let's turn our attention to the highlights of the quarter. The very strong execution continued in quarter one, building on the great momentum in 2025. And positionals well for the MC-8 US launch in ...