Q1 2026 Egetis Therapeutics AB (publ) Earnings Call Transcript
Key Points
- FDA acceptance of the new drug application for MCT8 with a priority review and a PDUFA target action date set for September 28, 2026.
- Successful oversubscribed directed share issue raising 350 million SEK with strong participation from U.S. biotech investors.
- Expansion of patient identification in the U.S. with over 140 genetically confirmed patients and a fully deployed field medical team.
- Progress in commercialization efforts in Europe with a 9% year-over-year revenue growth in Q1 2026.
- Strong launch readiness in the U.S. with infrastructure in place for market access and patient support, and a team of rare disease experts being established.
- Quarterly revenue was lower than Q4 2025 due to normal fluctuations in ordering patterns and accrual of rebates in Germany.
- Operating results were negative SEK 92.9 million, reflecting continued investment in U.S. NDA and commercial build-up.
- Gross profit was negative due to continued depreciation of balance sheet R&D, a non-cash item.
- Challenges in the European pricing and reimbursement environment, particularly in Germany, affecting revenue recognition.
- High workload on specialists in rare diseases in Germany, leading to difficulties in patient appointments and slower initiation of new treatments.
Welcome to Egetis Therapeutics Q1 Report 2026. (Operator Instruction) Now I will hand the conference over to Chief Executive Officer Nicklas Westerholm. Please go ahead.
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Good morning, and a warm welcome to our quarter one results planned for the coming 30 minutes. For those who haven't had the privilege to meet before, my name is Nick Rasvestron, I'm the CEO of the company.
With me today, we also have Yilmaz Mahshid, Chief Financial Officer, Henry Klug, Vice President, Commercial Operations, Anny Bedard, President of our U.S. Business, and Karl Hard, Vice President. and Head of Investor Relations. Let's turn to our attention to the topics covered today depicted on the slide in front of you.
To summarize, quarter one has been historical for Egetis, with several key milestones delivered. Amongst others, and most importantly, the FDA acceptance of our new drug application for MCT8 for the treatment of MCT8 deficiency.
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