Q2 2026 Egetis Therapeutics AB (publ) Earnings Call Transcript
Key Points
- FDA accepted the US NDA for Emcitate with priority review and a PDUFA date of September 28, 2026, with no advisory committee planned, indicating a smooth review process.
- US launch preparations are on track, with a fully built commercial organization, trained field teams, and contracted specialty distribution and supply partners, positioning for a Q4 launch.
- The US patent for Emcitate was granted, providing Orange Book-listed protection until 2045, strengthening the intellectual property portfolio.
- German AMNOG price negotiations concluded successfully, with an estimated average annual treatment cost just below EUR200,000, supporting revenue growth.
- Revenue grew 23% year-over-year at constant exchange rates, with a strong adjusted gross margin of approximately 79% in Q2 2026.
- A substantially oversubscribed SEK350 million directed share issue was completed at a 0% discount, strengthening the cash position to SEK378 million.
- The RTH-beta indication expansion is progressing, with over 50 patients already treated under a managed access program, and a clinical study planned for 2027.
- Operating results remain negative at SEK109.3 million in Q2 2026, reflecting continued heavy investments in US pre-launch activities.
- Reported gross profit is impacted by non-cash depreciation of balance sheet R&D, which will continue to weigh on margins during the European ramp-up phase.
- The company faces uncertainty regarding the transition of approximately 60 Expanded Access Program patients to commercial supply, with no specific timeline provided.
- The survival data for MCT8, which could support European reimbursement dossiers, has not yet been published in a peer-reviewed journal, delaying potential access in Italy and France.
- Cash flow from operating activities was negative SEK93.9 million in Q2 2026, indicating significant cash burn ahead of the US launch.
- The company is not providing detailed guidance on the RTH-beta development program, including endpoints and study size, creating uncertainty for investors.
- The US launch is contingent on FDA approval, and any delays or issues in the review process could impact the planned Q4 2026 launch.
Welcome to Egetis Therapeutics Q2 report 2026. (Operator Instructions)
Now, I will hand the conference over to CEO, Nicklas Westerholm. Please go ahead.
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Thank you, operator. Good afternoon, good morning, and a warm welcome to Egetis Therapeutics quarter-two results webcast, planned for the coming 30 minutes. For those who I haven't had the privilege to meet before, my name is Nicklas Westerholm, and I am the CEO of the company.
I will start today's session with a short business update. This will be followed by Anny Bedard, President of our US and North American Business, who will discuss the launch preparations for the planned Emcitate launch in the US, subject to approval. Then Henrik Krook, Vice President, Commercial Operations, will give a commercialization update of Emcitate in the European Union, as well as other international markets. Finally, Yilmaz Mahshid, Chief Financial Officer, will provide a financial update [before] we're
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