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Thank you for joining us for the EDAP TMS First Quarter twenty twenty five Financial and Operating Results Conference Call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer Ken Mobic, 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. 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.
13m 58s
We placed nine Focal One systems in the first quarter of twenty twenty five, which is a record number of placements for any prior first quarter period. In March, we announced that Focal One received CE Mark approval for the treatment of posterior deep infiltrating endometriosis. And in April, we launched the new Focal One Eye robotic HIFU system at this year's twenty twenty five AUA meeting. As our Focal One 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 FARP randomized controlled trial were presented at this year's twenty twenty five AUA meeting 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 Focal One from the global urology community.
15m 38s
I will now discuss our system placement activity for the first quarter. As noted, Focal One continued along its positive growth trajectory in the first quarter of twenty twenty five. We placed nine Focal One 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 and White Health and the second with Methodist Charleston Medical Center.
16m 18s
Baylor Scott and White Health is the largest nonprofit health care system in the state of Texas and ranks amongst the largest health care systems in The United States with nationally recognized medical services, including urology. Methodist Charleston 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 health care 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 One 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 U. S. Hospital cancer centers devoted to patient care research and education.
17m 56s
I am pleased to note that over half these NCCN member institutions now have access to our Focal One robotic HIFU platform. In addition, the University of Colorado also has an active Society of Urologic Oncology SUO, fellowship program. By establishing a Focal I training program within these highly regarded prestigious institutions, we can train the next generation leading urologists 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 12,400,000 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 twenty twenty five.
19m 32s
We reported HIFU revenues of EUR 6,200,000.0, as compared to EUR 5,800,000.0 for the first quarter of twenty twenty four. Up 6.8% a year over year basis. Total worldwide revenue was €13,600,000 a decrease of 9.1% as compared to total revenue of €14,900,000 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 One robotic HIFU platform. During the first quarter, U. S. Procedures grew approximately approximately 4% over the first quarter of twenty twenty four. While the demand for Focal One 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 One HIFU therapy. We continue to work diligently with our partners to increase market access and help accelerate pre authorizations for Focal One HIFU procedures. The recently published HIFU study continues to be instrumental in this process and has already begun to making a positive impact.
21m 4s
As previously discussed last quarter, we believe the recent publication of the landmark HiFi study in European urology will help drive additional Focal One adoption and procedure growth. To learn more about this compelling clinical evidence from this landmark study, I would encourage you to visit the website [indiscernible] 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 One 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 times.
22m 35s
I would now like to briefly discuss of our recent strategic collaborative activities. As noted earlier, we recently announced the world's first remote transatlantic Focal One 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 One robotic HIFU system, urologist Doctor. Walid Hasson in Cleveland Clinic Abu Dhabi managed the patient in the Operating Room locally while urologist Doctor. Ruben Oliveros in Cleveland Clinic Ohio connected remotely to the Focal One system in Abu Dhabi through an EDAP developed proprietary workstation. Doctor. Oliver's thus controlled the Focal One system in real time from Ohio and collaborated with Doctor. Hasson in Abu Dhabi to perform the procedure on the patient. This event represents an important clinical and technological in the treatment of prostate cancer for the Focal One 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 One 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 One with the ability to broaden patient access to expert care.
24m 16s
Vocal One'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 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 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 Haiku Masterclass was led by 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.
25m 47s
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 vocal ablation group is non inferior to that in the radical prostatectomy group at the final three year follow-up. A total of two thirteen patients were enrolled in the study with one hundred and seven patients randomized to receive focal ablation and one hundred and six to undergo radical prostatectomy. Results from the study show that the proportion of treatment failure was six point five percent in the focal ablation group which was lower compared to the eight point five percent 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 [indiscernible] Which also showed that HIFU therapy was non 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.
27m 15s
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 iRobotic HIFU system at this year's AUA. Vocal One Eye represents a significant advancement to our leading robotic HIFU platform that incorporates a number of cutting edge tech 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 twenty twenty five financial results also touch upon potential implications from recent U. S. Tariff activity. Thank you, Ryan, and good morning, everyone.
28m 45s
For conversion purposes, our average euro to dollar exchange rate was 1.05 for the first quarter of twenty twenty five. Total HIFU revenue for the first quarter of twenty twenty five was EUR6.2 million, an increase of 6.8% as compared to €5,800,000 for the first quarter of twenty twenty four. The increase in revenue was driven by six Focal One systems sold in the first quarter of twenty twenty five versus five systems sold in the first quarter of twenty twenty four. As well as increases in service related revenue. Total worldwide revenue for the first quarter of twenty twenty five was €13,600,000 a decrease of 9.1% as compared to total revenue of EUR14.9 million for the same period in 2024. The decrease in revenue was due to declines of 23.817.5% in our non core ESWL and distribution divisions respectively. As we discussed on our fourth quarter of twenty twenty four conference call, we expect revenue declines in our non core segments between 2025% from 2024 levels, as we focus on becoming a pure play market leader in therapeutic HIFU. Gross profit for the first quarter of twenty twenty five was EUR 5,700,000.0, compared to EUR 6,400,000.0 for the same period in 2024.
30m 21s
Gross profit margin was 42% in the first quarter of twenty twenty five. Compared to 42.8% in the year ago period. The decrease in gross profit margin year over year was primarily due to mix changes within our product portfolio. Operating expenses were €11,700,000 for the first quarter of twenty twenty five compared to €11,200,000 for the same period in 2024. The increase in operating expenses was primarily due to focused investments in our HIFU business segment. Operating loss for the first quarter of twenty twenty five was €6,000,000 compared to an operating loss of EUR 4,800,000.0 in the first quarter of twenty twenty four. Excluding the impact of noncash share based compensation operating loss for the first quarter would have been €5,700,000 compared to an operating loss of EUR 4,100,000.0 in Q1 twenty twenty four. Net loss for the first quarter of twenty twenty five was €7,100,000 or EUR 0.19 per diluted share, as compared to a net loss of €4,500,000 or €0.12 per diluted share in the year ago period. Inventory decreased to EUR 18,000,000 at the end of Q1 twenty twenty five as compared to €18,500,000 at the end of Q4 twenty twenty four. The decrease in inventory levels was due to our ongoing efforts to effectively balance our demand and supply base along with more efficient just in time inventory management with our distribution Total cash and cash equivalents at the end of Q1 were EUR 22,800,000.0 as compared to EUR29.8 million at the end of Q4 twenty twenty four.
32m 16s
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% tariff impact for all goods transferred from France to The U. S. For the second quarter. As previously noted, approximately 80% to 90% of our Focal One components come from France, along with 100% of the Focal One system being assembled in France. We will continue to monitor the potential impact from the Trump administration's tariff policies and adjust our forecast 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 One 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.
33m 40s
We continue to expect HIFU revenue to grow between 1625% on a year over year basis and the non core ESWL and distribution businesses to decline between 2025% on a year 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 One platform remains on a strong upward trajectory, and we believe the introduction of the new Focal One I system will further strengthen EDAP's technological leadership in focal therapy. As we continue to bring innovation and cutting edge technology to the Focal One 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, AUA will accelerate the adoption of focal therapy across the global urology community. These studies reinforce the oncologic efficacy of Focal One and support the favorable quality of life functional outcomes patients are demanding as Focal One is a nonsurgical noninvasive procedure that requires no cutting, no blood loss, and no use of radiation.
35m 17s
Finally, when we step back and look at the number of focal one placements, since the beginning of 2022, We are clearly experiencing a steady upward trend in demand that we believe will continue to gain momentum. As noted, we placed a record number of Focal One systems in in the first quarter and we are seeing growing interest in the Focal One platform. From many of the large hospital networks. These are clearly positive signs of Vocal One 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. [indiscernible] Thank you, sir. We'll go for our first question from Michael Sarcone with Jefferies. Please go ahead.
36m 13s
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 in procedure approvals. Maybe, 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 that starting to broaden out? Just trying to get a better sense of what's going on here. Yes. The comments in trends that I referenced are relevant to the Medicare Advantage Plan patients. As noted, about approximately fifty four percent of patients who are on a Medicare plan will opt for a Medicare Advantage plan or a Medicare Part C plan. 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 has been a core competency for the company. And we continue to see significant progress we And we continue to work through that [indiscernible] with individual payers and certainly with patients. So again, it's as referenced really in the area Medicare Advantage. That I made comment to.
37m 39s
Got it.
37m 40s
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, as mentioned, we see obviously more appeals happening. But we win and the majority of these appeals. Got it. That's helpful. Maybe last one for me, maybe for Ken. You've maintained your HIFU sales growth guidance of 16% to 25%. Would love to just get a sense for what's incorporated into those assumptions at the low end and the high end. And are you incorporating a meaningful acceleration in procedure growth? I think you said HIFU procedure growth 4%. Are we assuming in the guide that these payer challenges recede and you get an acceleration in 2H? Yes.
39m 13s
So great question. Thank you, Michael. So as you know, capital equipment environment is lumpy. We're holding guidance right now We do have procedure growth factored in our forecast right now. And where we see the business at this phase we're still confident that we will achieve in that range between 16% to 25% HIFU revenue growth for the year. Got it. Thank you, Ken.
39m 52s
We'll next go to Sean Lee with H. C. Wainwright. Hey, good morning guys and thanks for taking my questions.
40m
I just have a couple on the endometriosis front. So with the receptor, the CE Mark approval, what are your next steps on marketing Focal One for endometriosis in Europe? And also, maybe there's a follow-up to that. What are your plans for endometriosis in The US?
40m 20s
Thanks.
40m 24s
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 U. S, again, what we're doing now is remember, we're following up on the randomized controlled trial, the Phase two study our Phase II study and Phase III studies, in order to continue to track that data set and monitor those patients. As we've communicated in the past, there there was a a high number of patients post the randomized control trial that opted to have focal one ablation for their endometriosis. So we want to be able to use that data and carry that data set forward for future interactions with with the FDA in The U. S. But in the interim, we're working in this controlled launch phase in Europe with our recent CE Mark approval.
41m 49s
Very helpful. Thanks for that.
41m 54s
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.
42m 3s
I want to thank everyone for joining us on today's call and we look forward to seeing you at the upcoming Jefferies Global Healthcare Conference on Thursday, June 5, in New York City. Thank you.
42m 16s
Thank you. Ladies and gentlemen, that does conclude today's program. We thank you for your participation. You may disconnect at any time.
Key Insights
EDAP placed a record nine Focal One robotic HIFU systems in Q1 2025, including six cash sales and three operating leases, with significant placements in major U.S. hospital networks and international markets.
HIFU revenue grew 6.8% year-over-year to €6.2 million, while total worldwide revenue declined 9.1% to €13.6 million due to expected decreases in non-core segments as the company focuses on its core HIFU business.
The company reiterated 2025 guidance: HIFU revenue is expected to grow 16–25% year-over-year, while non-core ESWL and distribution businesses are projected to decline 20–25%.
Key milestones included CE Mark approval for Focal One in treating deep infiltrating endometriosis, the launch of the new Focal One iRobotic HIFU system, and the world’s first remote transatlantic Focal One robotic HIFU procedure.
Clinical data continues to support Focal One adoption, with positive results from the FARP randomized controlled trial and the HiFi study; payer challenges in Medicare Advantage are being addressed, and the company is considering financing options to support growth amid potential tariff impacts.
