EDAP TMS SA Q1 FY2025 earnings call

• Strategic decisions to focus on becoming the global leader in HIFU focal therapy. - Placed 9 Focal One systems in Q1 2025, a record for any first quarter. - Focal One received CE Mark approval for treating posterior deep infiltrating endometriosis in March. - Launched the new Focal One Eye Robotic HIFU system at the 2025 AUA Meeting. - Positive results from the FARP Randomized Controlled Trial presented at AUA Meeting. - World's first remote transatlantic Focal One Robotic HIFU procedure conducted. - Focal One robotic HIFU has CE Mark indication for deep infiltrating endometriosis.

HIFU revenues for the first quarter of 2025 were €6.2 million, an increase of 6.8% compared to €5.8 million in the first quarter of 2024. Total worldwide revenue was €13.6 million in Q1 2025, a decrease of 9.1% from €14.9 million in the same period of 2024. Non-core ESWL and distribution divisions declined by 23.8% and 17.5% respectively. HIFU revenue growth was driven by 6 Focal One systems sold in Q1 2025 compared to 5 in Q1 2024 and increases in service-related revenue.

• Reiterating 2025 revenue guidance: HIFU revenue expected to grow 16%-25% year-over-year. - Non-core ESWL and distribution businesses expected to decline 20%-25% year-over-year. - Anticipates continued growth in Focal One placements and adoption of focal therapy due to clinical data and new product launches.

• Payer landscape challenges with longer and more challenging reviews and procedure approvals, particularly for Medicare Advantage patients. - Potential 10% tariff impact for goods transferred from France to the U.S. starting in the second quarter, as approximately 80%-90% of Focal One components come from France.

Q: Ryan, you commented on changing trends in the payer landscape, specifically longer and more challenging reviews and procedure approvals. Can you elaborate?

A: The trends are relevant to Medicare Advantage plan patients. We're working closely with consulting firms and making progress, but it's in the Medicare Advantage area.

Q: Sean Lee asked about endometriosis CE Mark approval and plans.

A: We're in a controlled market entry in CE Mark countries, working with thought leaders. In the U.S., we're tracking data from trials for future FDA interactions while doing a controlled launch in Europe.