EDAP TMS SA Q1 FY2026 earnings call

Commercial rollout in endometriosis gains momentum in Europe with multiple hospitals investing in FOCAL-1 robotic HIFU. Participated in major scientific meetings. Croix-Rousse Hospital in Lyon is central to expansion. FOCAL-1 robotic HIFU programs for endometriosis launching. Positive long-term trial data. Collaborated with NYU Langone for symposium. Sponsoring CME course at Memorial Sloan Kettering. Strong presence at AUA meeting with various activities. Investor day planned on June 1st.

In the first quarter of 2026, the core HIFU business grew 78% compared to Q1 2025, with HIFU revenue reaching $11.6 million. The non-core distribution and ESWL businesses declined by 20%. Total company-wide revenue was $17.8 million, an increase of 25% from the prior year. Gross profit was $8.1 million, with a gross margin of 45.7%, up from 42% in the prior year quarter. Operating expenses were $15.5 million, leading to an operating loss of $7.4 million.

Reiterated full year 2026 guidance: core HIFU revenue expected in range of $50 to $54 million (34% to 45% growth over 2025) and combined non-core revenue in range of $22 to $26 million.

Q: Michael Sarcone asks about U.S. HIFU procedure growth, utilization, and sustainability.

A: Ryan responds about increased demand for non-radical treatments, expanded training, and ramping programs.

Q: Jason Bednar asks about U.S. market for HIFU, endometriosis financial contribution, and U.S. endometriosis efforts.

A: Ryan talks about U.S. market pipeline, endometriosis commercial activity, and U.S. endometriosis data timeline.

Q: Jason asks about AUA conference exposure and investor day.

A: Ryan discusses AUA activities and investor day updates including financial models, commercial strategy, new indications, and technology innovations.