EDAP TMS SA Q3 FY2024 earnings call

• Core Focal One HIFU business shows strong growth with 48.2% y-o-y revenue increase, U.S. procedures up 34% y-o-y. - Placed 3 Focal One systems in Q3, including Virginia Commonwealth University, Italy, Spain; early Q4 sale to St. David's Hospital. - CMS increased Medicare HIFU payment by 5.4%, strong physician reimbursement for HIFU. - Collaborated with Avenda Health for AI-assisted Focal One procedures. - Participated in key urology meetings, with Focal One simulations and presentations. - BPH Phase I/II study started, endometriosis program interim results showed safety and lesion volume reduction, 85% Sham arm patients crossed over to HIFU. - Dr. Lance Willsey appointed Interim Board Chair.

In the third quarter, total worldwide revenue was $14.4 million, with currency-adjusted growth of 11.6% y-o-y. The core Focal One HIFU business had 48.2% y-o-y revenue growth. HIFU business revenue in Q3 2024 was €4.5 million (vs €3 million in Q3 2023). Worldwide HIFU disposable revenue grew 35.3% y-o-y. Distribution business revenue was €6.6 million (vs €6 million in Q3 2023), driven by recurring laser sales. LITHO business revenue was €2 million (vs €2.7 million in Q3 2023) due to fewer lithotripsy unit sales.

• Expect strong fourth quarter performance. - Continues to see momentum in pipeline customers. - Anticipates meeting with FDA regarding endometriosis program to discuss additional data.

Q: Elaborate on hospital customers and F One pipeline, 2H vs 1H placements A: Ryan mentions good activity in Q3, some sales slipped into Q4, expecting stronger back half of the year, momentum in pipeline customers and strong clinical interest from urologists at events Q: Regarding the BPH study, when can we expect initial results and patient numbers A: Results not until later next year, study combines Phase I and II parts, has 30+ sites active, goal is to accelerate to more sites and expand protocol design for FDA Q: On the endometriosis program, how long follow patients and when to release longer-term results A: Continuing to follow patients outward of 12 months and beyond, expecting to use latest data analysis and follow-up to prepare for FDA meeting before end of year