EDAP TMS SA Q4 FY2025 earnings call

2025 was a transformative year with 39% revenue growth in core HIFU business. Strong U.S. market performance with record system placements and procedure growth. Increased utilization across hospitals. Achieved 15 Focal One placements worldwide in Q4 2025, including 14 cash sales. Expansion in customer base with leading academic centers and major community hospitals converting to Focal One. Received FDA clearance for next-generation ultrasound imaging. CMS finalized favorable reimbursement rates. Advancing clinical strategy for new indications like endometriosis and BPH. Active surgeon education activities such as attending urology congresses and hosting educational events.

For 2025 full year, HIFU revenue was 33.1 million euros, an increase of 39% compared to 23.8 million euros in 2024. Fourth quarter 2025 HIFU revenue was 11.7 million euros, a notable increase of 34% compared to 8.8 million euros in the same period of 2024. Total revenue for full year 2025 was 62.4 million euros, a decrease of 3% compared to 64.1 million euros in 2024, driven by a 27% decline in non-core distribution and ESWL businesses offsetting the 39% growth in core HIFU business.

Expect core HIFU revenue in 2026 to be in the range of 50 million to 54 million US dollars, representing 34% to 45% growth over 2025. Combined non-core revenue expected in the range of 22 million to 26 million US dollars. Confidence in capital placement momentum, expanding installed base, and procedure volume ramp.

Tariffs on imports of finished goods from France impacting revenue. Inventory reserve related to legacy parts affecting gross margin. Uncertainty in market adoption lifecycle of Focal 1 robotic HIFU.

Q: Can you give more color on splitting growth in procedures versus capital sales for HIFU?

A: Pipelines strong in U.S. and outside U.S. Procedure growth seen in Q4 28% over prior year, with capital sales leading but procedure and service revenue volumes picking up.

Q: Any impact from storms in U.S. on procedures?

A: No impact pointed to, nice ramp developing.

Q: Thoughts on first half and second half split for HIFU guide?

A: Q4 expected to be highest growth quarter revenue-wise, lowest in Q3, with less than 50% in first half and more in second half.

Q: Percentage of revenue impacted by Section 232 tariffs?

A: U.S. revenue from finished goods shipped from France impacted, budgeted $2.5 million in tariffs in 2026.

Q: Concerns regarding cash sales mitigated?

A: Cash sales leading theme going forward as hospitals recognize Focal One's value, no need for operational leases as much anymore.