Q4 2025 Egetis Therapeutics AB (publ) Earnings Call Transcript
Key Points
- Egetis Therapeutics AB (FRA:P0F) completed the US rolling NDA for Emcitate in January 2026, with an anticipated regulatory decision expected in September 2026.
- Emcitate revenue increased by 40% in 2025 compared to 2024, demonstrating strong commercial performance.
- The company received a breakthrough designation from the FDA for Emcitate, which could expedite the review process.
- Egetis has made significant progress in commercialization efforts across Europe, including successful launches and pricing advancements in key markets like Germany.
- The company has identified over 140 diagnosed patients in the US, indicating strong market formation and potential for growth post-approval.
- The gross profit margin was lower than historical figures due to non-recurring milestone payments and R&D depreciation.
- Operating results were slightly lower for the year, with a negative SEK 340 million compared to negative SEK 329 million in the previous period.
- Cash flow from operating activities was negative SEK 267 million, reflecting increased costs and investments.
- The cash position decreased to SEK 215.8 million from SEK 351 million the previous year, indicating a need for careful financial management.
- The company faces complex and lengthy national pricing and reimbursement processes in Europe, which could delay market access and revenue generation.
Welcome to Egetis Therapeutics Q4 Report 2025.
(Operator Instructions)
Now I will hand the conference over to CEO Nicklas Westerholm. Please go ahead.
()-
Good morning, everyone, and a warm welcome to our quarter 4 results call planned for the coming 30 minutes. With me today, our CFO, Yilmaz Mahshid, Henrik Krook, Vice President Commercial Operations, Anny Bedard, President Egetis North America, and Karl Hard, Vice President, Investor Relations.
Let us turn to the attention of the topics being covered today, but first, let me start off saying that I'm incredibly pleased with the year in passing and also the delivery of those posts the period.
The completion of the US rolling NDA in January 2026 for Emcitate on the back of a successful pre-NDA meeting, a breakthrough designation granted by the FDA leads us to an anticipated regulatory decision in September this year.
The commercial performance, where Emcitate
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