EDAP TMS S.A.

I would like to welcome everyone to EDAP's TMS first quarter 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press star, then the number one on your telephone keypad. If you would like to withdraw your question, please press star, then the number two on your telephone keypad. Today's call is being recorded. I would now like to turn the call over to John Francis. Please go ahead.

Good morning. Thank you for joining us for the EDAP TMS First Quarter 2025 Financial and Operating Results Conference Call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, Ken Mobick, Chief Financial Officer, and Francois Dietsch, Chief Accounting Officer. Before we begin, I would 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. I would now like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes.

Thank you, John, and good morning, everyone. Over the last several months, EDAP has made a series of important strategic decisions to further transform our company in becoming the global leader in HIFU focal therapy. In support of this strategy, we announced a series of important achievements, which demonstrate the beginning of this transformation across multiple areas of our business. We placed nine focal one systems in the first quarter of 2025, which is a record number of placements for any prior first quarter period. In March, we announced that FOCAL1 received CE mark approval for the treatment of posterior deep infiltrating endometriosis. And in April, we launched the new FOCAL1i robotic HIFU system at this year's 2025 AUA meeting. As our FOCAL1 business continues to achieve these important milestones, we are also seeing a growing body of clinical data in support of robotic focal therapy for the management of prostate cancer. Most notably, positive results from the FARC randomized controlled trial were presented at this year's 2025 AUA meeting, which we will discuss in more detail later on this call. Finally, we announced that urologists from the Cleveland Clinic Ohio and the Cleveland Clinic Abu Dhabi conducted the world's first remote transatlantic focal one robotic HIFU procedure. A presentation discussing this groundbreaking procedure was to be delivered at this year's AUA meeting, and later on the call, I will provide additional details about this groundbreaking event. Collectively, these significant commercial, regulatory, and clinical milestones reflect our continued strategic focus on growing our core HIFU business and further validates the growing demand for FOCAL1 from the global urology community. I will now discuss our system placement activity for the first quarter. As noted, FOCAL1 continued along its positive growth trajectory in the first quarter of 2025. We placed nine FOCAL1 robotic systems in the quarter, which is a record number of system placements for any first quarter period in our company's history. The nine placements included six cash sales and three operating leases. In the United States, our two cash sales were placed in Dallas, Texas, one with Baylor Scott & White Health and the second with Methodist Charlton Medical Center. Baylor Scott & White Health is the largest nonprofit healthcare system in the state of Texas and ranks amongst the largest healthcare systems in the United States. with nationally recognized medical services, including urology. Methodist Charlton Medical Center is part of the Methodist Health System, which has a network of 13 hospitals and more than 75 primary care and specialty clinics located throughout the region. We believe the investment being made by such prominent community healthcare systems further reflects the growing recognition that focal one is fast becoming a medical necessary treatment option for prostate cancer patients. Importantly, both of these large healthcare systems operate in a very competitive environment within the fourth largest metropolitan statistical area in the United States, which represents another significant opportunity for FOCAL 1 to reach a large and important patient population. We also signed individual focal one operating leases with three major hospital providers. These included Vanderbilt University, University of Colorado, and Kaiser Sacramento in Northern California. Both Vanderbilt University and the University of Colorado are members of the National Comprehensive Cancer Network, or NCCN, which is an alliance of 33 of the leading US hospital cancer centers devoted to patient care research and education. I am pleased to note that over half of these NCCN member institutions now have access to our FOCAL-1 robotic HIFU platform. In addition, the University of Colorado also has an active Society of Urologic Oncology SUO fellowship program. By establishing a FOCAL-1 training program within these highly regarded prestigious institutions, We can train the next generation of leading neurologists to become proficient in the use of robotic focal therapy to manage their prostate cancer patients. Our placement with Kaiser Permanente Sacramento is also notable, as this is our second placement within this large and influential healthcare network. Kaiser is one of America's leading healthcare providers and nonprofit health plans serving approximately 12.4 million people. We are highly encouraged to see a growing number of Focal One systems being placed within these larger healthcare networks, and we anticipate this positive trend continuing throughout 2025 and beyond. Our Focal One business in the international markets also continues to gather momentum. In the first quarter, we completed four cash sales of Focal One outside of the United States which included system placements throughout Europe, the Middle East, and Asia. I will now briefly touch on some key financial and operating metrics for the first quarter of 2025. We reported HIFU revenues of 6.2 million euros as compared to 5.8 million euros for the first quarter of 2024, up 6.8% on a year-over-year basis. Total worldwide revenue was 13.6 million euros a decrease of 9.1% as compared to total revenue of 14.9 million euros for the same period in 2024. As noted on our fourth quarter conference call, the decline in non-core revenue was expected based on the strategic decision to focus exclusively on our high growth opportunity to become the global leader in focal therapy with our FocalOne robotic HIFU platform. During the first quarter, U.S. procedures grew approximately 4% over the first quarter of 2024. While the demand for FOCA-1 amongst the U.S. urology community continues to remain strong, over the last few months, we have experienced longer and more challenging review and procedure approvals, especially for patients enrolled in Medicare Advantage plans. To be clear, this appears to be an industry-wide issue and not one specific to FOCA-1 HIFU therapy. We continue to work diligently with our partners to increase market access and help accelerate pre-authorizations for FOCAL-1 HIFU procedures. The recently published HIFI study continues to be instrumental in this process and has already begun to making a positive impact. As previously discussed last quarter, we believe the recent publication of the landmark HIFI study in European urology will help drive additional FOCAL-1 adoption and procedure growth. To learn more about this compelling clinical evidence from this landmark study, I would encourage you to visit the website, hifistudy.com, which provides an excellent, easy-to-understand summary of the clinical data. I will now provide a brief update on our clinical programs. In March, we announced that focal and robotic HIFU received CE mark indication for the treatment of deep infiltrating endometriosis. As a reminder, Deep infiltrating endometriosis is a severe chronic inflammatory disease affecting young women of reproductive age and is also recognized as the most aggressive form of this disease. Receiving this CE mark from the European Union Notified Body represents a significant regulatory milestone, enabling us to proceed with a controlled market entry while we continue to work with endometriosis experts and thought leaders to further refine and expand our clinical development efforts for addressing this disease. We also believe this milestone represents the first step in enabling women to gain access to this important non-invasive treatment alternative to surgical intervention, which is associated with notable complication side effects and extended recovery time. I would now like to briefly discuss some of our recent strategic collaborative activities. As noted earlier, we recently announced the world's first remote transatlantic Focal-1 robotic HIFU procedure. This landmark procedure was performed across a distance of over 7,000 miles between two globally recognized Cleveland Clinic hospitals. Using EDAP's leading Focal-1 robotic HIFU system, urologist Dr. Waleed Hassan in Cleveland Clinic Abu Dhabi managed the patient in the operating room locally while urologist Dr. Ruben Olivares in Cleveland Clinic, Ohio, connected remotely to the FOCAL1 system in Abu Dhabi through an EDAP-developed proprietary workstation. Dr. Olivares thus controlled the FOCAL1 system in real time from Ohio and collaborated with Dr. Hassan in Abu Dhabi to perform the procedure on the patient. This event represents an important clinical and technological milestone in the treatment of prostate cancer for the FOCAL1 platform, and we would like to congratulate the entire Cleveland Clinic team on this historic event. We believe this achievement will serve as a first step in a series of continued innovations that will further position FOCAL1 as a leading platform for focal therapy. Longer term, we anticipate remote procedure capabilities will facilitate more efficient and effective training and mentoring of surgeons on FOCAL1 with the ability to broaden patient access to expert care. FOCAL1's reputation continues to grow as being the most compatible, scalable, and sought-after technology platform for focal therapy, and we continue to expect additional collaborations in the future as we expand our presence in the management of prostate cancer and into other potential new indications. I would now like to discuss our recent scientific conference activity. Ahead of this year's recent American Urological Association meeting, the AUA, we partnered with leading academic urology team from the University of Southern California to hold the first ever master class on robotic focal HIFU for prostate cancer. This event took place on April 24th and 25th in Los Angeles, two days in advance of this year's AUA meeting. The event was extremely well attended, attracting approximately 100 urologists from 14 countries around the world. EDAP was the sole sponsor of this event, and Focal One was the exclusive technology presented throughout the program. The Robotic Focal HIFU Masterclass was led by world-renowned faculty and featured several live Focal One procedures, while offering hands-on Focal One simulation sessions for attendees. Moving on to the important AUA meeting this year, we had our largest presence ever. As you know, the AUA is the largest meeting in the world focused on urology, and a significant number of presentations were made that highlighted the growing body of clinical data that is being generated from focal one HIFU procedures. Of particular importance, results from the much anticipated FARP randomized controlled trial were presented at this year's meeting. This level one evidence study achieved its primary endpoint and demonstrated that the rate of treatment failure in the focal ablation group is not inferior to that in the radical prostatectomy group at the final three-year follow-up. A total of 213 patients were enrolled in the study, with 107 patients randomized to receive focal ablation and 106 to undergo radical prostatectomy. Results from the study show that the proportion of treatment failure was 6.5% in the focal ablation group, which was lower compared to the 8.5% in the radical prostatectomy group. As a randomized controlled trial, the FARB study represents the first level one evidence in support of HIFU therapy and mirrors the positive outcomes observed from larger landmark HIFI study, which also showed that HIFU therapy was not inferior to radical prostatectomy. We believe the cumulative impact from these rigorous data sets all point towards increased adoption of focal therapy for addressing early stage prostate cancer. And we anticipate a growing number of clinical studies showing the benefits of focal one will continue to emerge in the major scientific meetings that focus on both urology and prostate cancer. In addition, this growing body of clinical evidence will be instrumental in further advancing discussions on prostate cancer and treatment guidelines and in positively shaping coverage policies among healthcare insurance carriers. Another major announcement for the company was the launch of the new Focal One Eye robotic HIFU system at this year's AUA. Focal One Eye represents a significant advancement to our leading robotic HIFU platform that incorporates a number of cutting-edge technology advancements. These include additional compatibility with the latest diagnostic imaging modalities, AI-based algorithms, along with remote procedure and collaboration capabilities. The new design of the Focal One Eye System, along with these additional features, are based directly on the feedback of our customers, as well as anticipating the future needs of surgeons performing focal therapy. I will now turn the call over to Ken, who will review our first quarter 2025 financial results and also touch upon potential implications from recent U.S. tariff activity.