EDAP TMS S.A.

Today I'd like to welcome everyone to EDAP's CMS First Quarter 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers' 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 Moebik, Chief Financial Officer, and Francois Dietsch, Chief Counting 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 high-food 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-1 systems in the first quarter of 2025, which is a record number of replacements for any prior first quarter period. In March, we announced that focal-1 received CE-mark approval for the treatment of posterior deep infiltrating endometriosis. And in April, we launched the new focal-1i robotic high-food system at this year's 2025 AUA meeting. As our focal-1 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-1 robotic high-food 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 high-food business and further validates the growing demand for focal-1 from the global urology community. I will now discuss our system placement activity for the first quarter. As noted, focal-1 continued along its positive growth trajectory in the first quarter of 2025. We placed nine focal-1 robotic systems in the quarter, which is a record number of system placings 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, and White Health, and the second with Methodist-Charlton Medical Center. Baylor, Scott, and 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-1 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-1 operating leases with three major hospital providers. These included Vanderbilt University, the 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 U.S. 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-1 systems being placed within these larger healthcare networks, and we anticipate this positive trend continuing throughout 2025 and beyond. Our focal-1 business in the international markets also continues to gather momentum. In the first quarter, we completed four cash sales of focal-1 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 .8% on a -over-year basis. Total worldwide revenue was 13.6 million euros, a decrease of .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 focal-1 robotic HIFU platform. During the first quarter, U.S. procedures grew approximately 4% over the first quarter of 2024. While the demand for focal-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 focal-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 make 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, -to-understand summary of the clinical data. I will now provide a brief update on our clinical programs. In March we announced that focal-1 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 complications, 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 Oliveris in Cleveland Clinic Ohio connected remotely to the focal-1 system in Abu Dhabi through an EDAP-developed proprietary workstation. Dr. Oliveris thus controlled the focal-1 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 focal-1 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 focal-1 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 focal-1 with the ability to broaden patient access to expert care. Focal-1'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 hyphu 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-1 was the exclusive technology presented throughout the program. The robotic focal hyphu master class was led by world-renowned faculty and featured several live focal-1 procedures while offering hands-on focal-1 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-1 hyphu procedures. Of particular importance, results from the much anticipated FARP randomized controlled trial were presented at this year's meeting. This level-1 evidence study achieved its primary endpoint and demonstrated that the rate of treatment failure in the focal ablation group is non-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 .5% in the focal ablation group, which was lower compared to the .5% in the radical prostatectomy group. As a randomized controlled trial, the FARP study represents the first level-1 evidence in support of hyphu therapy and mirrors the positive outcomes observed from larger landmark HIFI study, which also showed that hyphu 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-1 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 -1-i robotic hyphu system at this year's AUA. -1-i represents a significant advancement to our leading robotic hyphu 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 -1-i 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.

Thank you, Ryan, and good morning, everyone. For conversion purposes, our average euro to dollar exchange rate was 1.05 for the first quarter of 2025. Total hyphu revenue for the first quarter of 2025 was 6.2 million euros, an increase of .8% as compared to 5.8 million euros for the first quarter of 2024. The increase in revenue was driven by six focal-1 systems sold in the first quarter of 2025 versus five systems sold in the first quarter of 2024, as well as increases in service-related revenue. Total worldwide revenue for the first quarter of 2025 was 13.6 million euros, a decrease of .1% as compared to total revenue of 14.9 million euros for the same period in 2024. The decrease in revenue was due to declines of .8% and .5% in our non-core ESWL and distribution divisions, respectively. As we discussed on our fourth quarter of 2024 conference call, we expect revenue declines in our non-core segments between 20 and 25% from 2024 levels as we focus on becoming a pure play market leader in therapeutic hyphu. Ro's profit for the first quarter of 2025 was 5.7 million euros, compared to 6.4 million euros for the same period in 2024. Ro's profit margin was 42% in the first quarter of 2025, compared to .8% in the year-ago period. The decrease in Ro's profit margin -over-year was primarily due to mixed changes within our product portfolio. Operating expenses were 11.7 million euros for the first quarter of 2025, compared to 11.2 million euros for the same period in 2024. The increase in operating expenses was primarily due to focused investments in our hyphu business segment. Operating loss for the first quarter of 2025 was 6 million euros, compared to an operating loss of 4.8 million euros in the first quarter of 2024. Including the impact of non-cash share-based compensation, operating loss for the first quarter would have been 5.7 million euros, compared to an operating loss of 4.1 million euros in Q1 2024. Net loss for the first quarter of 2025 was 7.1 million euros, or 0.19 euros per diluted share, as compared to a net loss of 4.5 million euros, or 0.12 euros per diluted share in the year-ago period. Inventory decreased to 18 million euros at the end of Q1 2025, as compared to 18.5 million euros at the end of Q4 2024. The decrease in inventory levels was due to our ongoing efforts to effectively balance our demand and supply base, along with more efficient -in-time inventory management with our distribution partners. Total cash and cash equivalents at the end of Q1 were 22.8 million euros, as compared to 29.8 million euros at the end of Q4 2024. The decrease was driven primarily by the cash used in operating activities. Respect to the ongoing changes in tariff policies, there was no impact to our first quarter results. However, based on our latest estimates, we are currently forecasting a 10 percent tariff impact for all goods transferred from France to the U.S. for the second quarter. As previously noted, approximately 80 to 90 percent of our Focal 1 components come from France, along with 100 percent of the Focal 1 system being assembled in France. We will continue to monitor the potential impact from the Trump administration's tariff policies and adjust our forecasts accordingly. We continue to monitor our cash flow closely, focusing on working capital management while actively balancing the need to invest and grow our HIFU business. Based on our strategic focus in growing our Focal 1 business, we are currently considering a broad range of potential financing options that will strengthen our balance sheet and support our market-leading position in therapeutic HIFU. I would like to now turn the call back to Ryan for closing comments.

Thanks, Ken. With respect to guidance, we are reiterating the 2025 revenue guidance which we first issued on our fourth quarter call in late March. We continue to expect HIFU revenue to grow between 16 and 25 percent on a -over-year basis. In summary, we continue to focus on our strategic plan in becoming the global leader in Focal Therapy, and our recent positive announcements demonstrate that we are making progress towards achieving these goals. Demand for our leading Focal 1 platform remains on a strong upward trajectory, and we believe the introduction of the new Focal 1 iSystem will further strengthen EDAP's technological leadership in Focal Therapy. As we continue to bring innovation and cutting-edge technology to the Focal 1 platform, a growing body of clinical data provides additional evidence that supports the use of focal therapy for prostate cancer. We believe the positive results from the landmark Hi-Fi study, coupled with the recent presentation of the FARC randomized clinical trial data at this year's AUA, will accelerate the adoption of focal therapy across the global urology community. These studies reinforce the oncologic efficacy of Focal 1 and support the favorable quality of life functional outcomes patients are demanding, as Focal 1 is a non-surgical, non-invasive procedure that requires no cutting, no blood loss, and no use of radiation. Finally, when we step back and look at the number of Focal 1 placements since the beginning of 2022, we are clearly experiencing the steady upward trend and demand that we believe will continue to gain momentum. As noted, we placed a record number of Focal 1 systems in the first quarter, and we are seeing growing interest in the Focal 1 platform from many of the large hospital networks. These are clearly positive signs of Focal 1 adoption, and we expect this trend will continue in 2025 and beyond. With that, I will now turn the call back over to the operator for questions.

Operator? Operator? Thank you, sir. At this time, if you would like to ask a question, please press star 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2, and once again, that is star 1. We'll go for our first question from Michael Sarkone with Jeffreys. Please go ahead.

Good morning, and thanks for taking our questions. Just to start, Ryan, you commented on some maybe changing trends on the payer landscape, longer and more challenging reviews and procedure approvals. Maybe, you know, can you just elaborate some more here? You know, when exactly did you start seeing this? Is it only in the Medicare Advantage population, or are you seeing it starting to broaden out, just trying to get a better sense of what's going on here?

Yeah, the comments in transit I referenced are relevant to the Medicare Advantage plan patients. As noted, about approximately 54% of patients who are on a Medicare plan will opt for a Medicare Advantage plan or a Medicare Part C plan. You know, we continue to work closely through this process. We're working with one of the largest and most capable consulting firms, and reimbursement and market access has been a core competency for the company. And we continue to see significant progress, and we continue to work through that process with individual payers and certainly with patients. So again, it's as referenced really in the area of Medicare Advantage that I made comment to.

Got it. I see. And so has that continued into 2Q, and are you ultimately able to get, you know, the procedure approved, it just takes longer, or are you seeing, you know, any portion of these processes end up in denial?

Well, there's always the risk of some denials, but we show notable progress of appeals and working through that process with, and we see more patients obviously winning on the appeal front. So again, we stay very active in the process. We work very closely with the individual institutions, and we monitor it through use of our outside consulting partners. So again, we, as mentioned, we see obviously more appeals happening, but we win in the majority of these appeals.

Yeah, that's helpful. Maybe last one for me, maybe for Ken. You've maintained your HIFU sales growth guidance of 16 to 25 percent. Would love to just get a sense for what's incorporated into those assumptions at the low end and the high end. Are you incorporating a meaningful acceleration in procedure growth? I think you said HIFU procedure growth, 4 percent. You know, are we assuming in the guide that, you know, these payer challenges recede and you get an acceleration in 2H? Yeah,

so great question. Thank you, Michael. So as you know, capital equipment environment is lumpy. We're holding guidance right now. We do have, you know, procedure growth factored in our forecast right now. And, you know, where we see the business at this phase, we're still confident that we will achieve in that range between 16 to 25 percent HIFU revenue growth

for the year. Got it. Thank you,

Ken. We'll next go to Sean Lee with HCE Wainwright.

Hey, good morning, guys, and thanks for taking my questions. I just have a couple on the endometriosis front. So with the reception of the CE mark approval, what are your next steps on marketing for global endometriosis in Europe? And also, maybe as a follow up on to that, what are your plans for endometriosis in the US? Thanks.

Yeah, as referenced, we have embarked on a controlled market entry in CE mark countries. So we're working with a small group of initial hospitals based on receiving CE mark approval. And so, again, our goal there is to continue to work with those thought leaders and really expand the clinical development efforts in preparation for a broader launch amongst CE mark countries. So it's kind of a stepwise approach. We're in this first phase, and then we'll move to a secondary phase. In terms of the US, again, what we're doing now is, remember, we're following up on the randomized control trial, the phase two study, phase two study and phase three studies in order to continue to track that data set and monitor those patients. As we've communicated in the past, there was a high number of patients post the randomized control trial that opted to have focal one ablation for the endometriosis. So we want to be able to use that data and carry that data set forward for future interactions with the FDA in the US. But in the interim, we're working in this controlled launch phase in Europe with our recent CE mark approval.

That's very helpful. Thanks for that.

And at this time, we have no further questions. I'd like to turn the call back over to Ryan Rhodes for final and closing remarks.

I want to thank everyone for joining us on today's call, and we look forward to seeing you at the upcoming Jeffries Global Healthcare Conference on Thursday, June 5th in New York City. Thank you.

Thank you. And ladies and gentlemen, that does conclude today's program. We thank you for your participation. You may disconnect at any time.