EDAP TMS SA Q3 FY2025 earnings call

• Record overall quarterly revenue of USD 16.1 million in Q3 2025, with HIFU revenue at USD 7.7 million (57% y-o-y growth).
• 8 Focal One placements (6 capital sales, 2 operating leases) in Q3 2025, a 167% growth from the same period a year ago.
• Focal One integrated in 21 of 35 SUO approved fellowship programs (60% of academic centers).
• U.S. Focal One procedures grew over 15% y-o-y.
• Peer-reviewed study in Journal of International Urology and Nephrology showed HIFU had non-inferior 10-year oncological outcomes vs external beam radiation therapy for Stage II prostate cancer.
• IRB approval for U.S. BPH clinical study with Mount Sinai; first patient enrollment expected by end of 2025.
• Phase III RCT on endometriosis showed HIFU group had significant symptom improvement at 3 months and 1-year, with over 85% of sham group patients choosing HIFU after unblinding.
• Focal One received 2025 Industry Award for innovations in Endourological Instrumentation at WCET meeting.

For the third quarter of 2025, EDAP TMS had global revenues of USD 16.1 million. The core HIFU business was the driver of growth, with HIFU revenue reaching USD 7.7 million, a 57% increase compared to the third quarter of the previous year. This represents 47.8% of the total global revenue. The noncore distribution and ESWL businesses declined by 16% in Q3 2025 versus Q3 2024. For the 9 months ending September 30, 2025, HIFU revenue was EUR 21.3 million, an increase of 42% over the same period in 2024, while total revenue was EUR 43.5 million compared to EUR 43.8 million in the prior year.

• Maintaining financial guidance for 2025: core HIFU business revenue expected to grow 26%-34% y-o-y.
• Combined noncore ESWL and distribution business revenue expected to decline 25%-30% y-o-y.
• Full-year 2025 revenue guidance remains between USD 58 million and USD 62 million.

• Forecasted 15% tariff impact for goods transferred between France and the U.S., with year-to-date impact of EUR 300,000 and estimated full-year impact of EUR 900,000.
• Monitoring potential impact of U.S. tariff policies going forward.

Q: Could you give more color on the EIB deal, how proceeds will be used and if for U.S. or international business?

A: Proceeds are for operating areas including product development (R&D), clinical development, and commercial growth, centered around the HIFU core business.

Q: Can you comment on how many U.S. Focal One procedures were covered and if procedure volume will grow as coverage expands?

A: Some are Medicare, Medicare Advantage, and commercial patients. Saw improvement in Medicare Advantage plans and expect to continue driving momentum there.

Q: Could you remind us about Q4 expectations given Q3 is typically seasonally soft?

A: Reiterating 2025 guidance of USD 58 million to USD 62 million for the year, confident Q4 will be in that range to hit year-end targets