EDAP TMS S.A.

Hello and welcome everyone joining today's EDAP TMS third quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during the question and answer session. To register to ask a question at any time, please press star one on your telephone keypad. Please note this call is being recorded and I am standing by should you need any assistance. It is now my pleasure to turn the meeting over to John Francis, With LifeSci Advisors, please go ahead.

Good morning. Thank you for joining us for the EDAP TMS third quarter 2025 financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, Ken Mobik, Chief Financial Officer, and Francois Dietsch, Chief Accounting Officer. Before we begin, I'd like to remind everyone that management's remarks today may contain forward-looking statements, which include statements regarding the company's growth and expansion plans, Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. Now I'd like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes. Ryan?

Thank you, John, and welcome, everyone. The third quarter of 2025 marked another strong quarter for EDAP as we continue to execute on our mission to make focal one the standard of care for localized prostate cancer. With global revenues of 16.1 million US dollars, this is the second consecutive quarter with record overall quarterly revenue for the respective period. Additionally, This is also a record for HIFU revenue for a third quarter, which reflects consistent commercial execution, expanding clinical adoption, and growing recognition of the value FOCA-1 robotic HIFU brings to patients, physicians, and hospitals. During the quarter, our HIFU revenue reached $7.7 million, U.S. dollars, representing a 57% increase compared to the third quarter of last year. This is consistent with our previously announced strategy of focusing our investments in the company's core HIFU business. We recorded eight FOCA I placements, including six capital sales and two operating leases. This represents growth of 167% as compared to the same period a year ago, reflecting the growing confidence hospitals have in adopting FOCA-1 robotic HIFU as an integral cornerstone of their prostate cancer program. With new placements this quarter at the University of Virginia and the University of Michigan, Focal One has now been integrated within 21 of the 35 Society of Urologic Oncology, or SUO, approved fellowship programs, representing 60% of all such academic centers nationwide. Our growing presence across these leading urology centers is instrumental in training the next generation of urologists while accelerating clinical awareness and adoption of HIFU focal therapy as a mainstream treatment option for prostate cancer. Focal-1 procedures in the U.S. grew more than 15% year over year, making a return to double-digit growth. This acceleration reflects the growing clinical adoption of Focal-1 combined with the impact of our sustained investment in market access initiatives. We are seeing meaningful progress in reimbursement coverage with commercial payers, particularly among Medicare Advantage providers, which is driving broader patient access and stronger hospital economics. On the clinical front, an important peer-reviewed scientific study was recently published in the Journal of International Urology and Nephrology. This study concluded that HIFU delivered non-inferior 10-year oncological outcomes as compared to external beam radiation therapy in patients with stage 2 prostate cancer. Both the overall survival and cancer-specific survival rates were higher in the HIFU group with a statistically significant overall survival benefit favoring HIFU in early stage disease. This is an important addition to the growing body of evidence supporting HIFU in the treatment of prostate cancer. While both the HIFI and FARP studies are already showing strong mid-term cancer control as compared to surgery, this new publication further validates HIFU with favorable long-term follow-up data compared to radiation therapy. Together, these results continue to strengthen the clinical foundation for the FOCA-1 platform and HIFU's role in the treatment of localized prostate cancer. On the reimbursement front, the latest hospital and physician payment rules released by the Center for Medicare and Medicaid Services, or CMS, continue to reinforce the important use case of HIFU thus providing hospitals and physicians with a clear and predictable Medicare reimbursement pathway. In addition, several commercial payers, both local and national, have started to routinely approve individual claims around the country, particularly within Medicare Advantage plans, further reinforcing the positive economics driving adoption. I will now briefly touch on our development and focused areas to expand into new clinical indications. We are making meaningful progress in our benign prostatic hyperplasia or BPH clinical development program, which represents another major growth opportunity for the company. While our combined Phase I-II multicenter study is progressing to plan in Europe, We are proud to report institutional review board or IRB approval for the U.S. BPH clinical study in partnership with the Icahn School of Medicine at Mount Sinai in New York City, a prestigious academic hospital and recognized leader in urology innovation. This study will evaluate use of Focal-1 robotic HIFU for the treatment of BPH building further on our clinical experience in Europe. Our goal is to demonstrate that FOCAL-1's precision and image-guided approach can offer an effective, non-invasive, tissue-sparing alternative to conventional treatment options.