EDAP TMS S.A.

Greetings and welcome to the EDAB TMS first quarter 2026 conference call. As a reminder, this conference call is being recorded. I would now like to turn the call over to Louisa Smith from Gilmartin Group. Please go ahead.

Good morning. Thank you for joining us for the EDAP TMS First Quarter 2026 Financial and Operating Results Conference Call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, Ken Mobeck, 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 within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and involve risks and uncertainties that could cause actual results to differ materially from those anticipated. we direct you to the risk factors section of our most recently filed annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission, as well as our other filings with the SEC for a description of factors that may cause such differences. These statements speak only as of today's date, and we undertake no obligation to update or revise them except as required by law. Additionally, this call is being recorded and constitutes a public disclosure for purposes of regulation FD. I would now like to turn the call over to Chief Executive Officer Ryan Rhodes.

Thank you, Louisa, and good morning, everyone. As announced this morning, we delivered a strong first quarter. We reported record first quarter total revenue for the company of $17.8 million led by record first quarter Focal 1 robotic HIFU revenue of $11.6 million, further reinforcing the momentum we highlighted on our previous fourth quarter call. Today, I will provide additional color on new system placements, growing utilization trends, and our ongoing indication expansion efforts before turning the call over to Ken to review our financial results. Before discussing the quarter in more detail, I would like to remind everyone that effective January 1st of this year, EDAP becomes a U.S. domestic issuer. As a result, beginning this quarter, we will report all financial results in U.S. dollars on a go-forward basis.

Now, turning to our first quarter results.

Our HIFU business continues to demonstrate strong and sustained momentum. We have now delivered seven consecutive quarters of year-over-year growth in the segment, reflecting increasing physician adoption, expanding utilization, and growing global demand for FOCAL-1 robotic HIFU technology. We delivered record revenue across our core HIFU business driven by strong growth in both system placements and procedure volumes across U.S. and international markets. During the quarter, we recorded 11 capital sales and 10 total net placements, further reinforcing the strength and growing visibility of our TOCA1 pipeline. In the quarter, we continued to extend adoption across many of the most prestigious academic cancer centers in the United States. As noted, University of Pittsburgh Medical Center, UPMC, converted to a cash sale, and Moffitt Cancer Center became the 10 focal one system installed in the state of Florida. These placements further validate FOCAL1's emergence as a leading robotic focal therapy platform being adopted and utilized by top-ranked institutions nationwide. We also place the second FOCAL1 system within the Mass General Brigham Healthcare Network. With this addition, 11 U.S. hospital and health networks have now invested in and launched two or more focal one robotic high food programs, underscoring the growing utilization, confidence, and long-term commitment we are seeing from major healthcare systems. Internationally, we achieved a record six capital sales in the first quarter, reflecting the continued expansion of our global commercial reach. supported by our established and growing sales channel infrastructure. Performance in Europe was particularly strong. In France, we completed our first cash sale following the French National Health System's decision to provide universal coverage for the FOCAL-1 HIFU procedure. As a reminder, this coverage decision was supported by results from the landmarks HIFI study, a large prospective comparative trial that demonstrated positive efficacy outcomes for Focal-1 robotic HIFU as compared with radical prostatectomy in the treatment of prostate cancer. This quarter also marked the first time our Focal-1 capital sales were driven by demand across two clinical indications, prostate cancer and deep infiltrating endometriosis. further highlighting the value of FOCAL1 as both a multi-specialty and multi-indication treatment platform. In the United Kingdom, Cleveland Clinic London converted to a cash sale supported by strong engagement from global thought leaders in both urology and gynecology departments, which plan to utilize FOCAL1 robotic HIFU for the treatment of both prostate cancer and endometriosis. In Eastern Europe, we achieved our first FOCAL1 cash sale in Hungary, driven by the hospital's strategic initiative to expand treatment capabilities for both prostate cancer and endometriosis. These placements are important as they recognize FOCAL1 robotic HIFU as the only multi-indication focal therapy platform to deliver broad clinical utility across both men's and women's health. In the Americas, we delivered our first focal one system in Mexico, further expanding our growing clinical regional footprint, which now includes Brazil, Argentina, Chile, Panama, and Mexico.

This is a result of our growing and expanding sales channel throughout this region. Turning to utilization, U.S.

procedure volumes increased 53% year over year. This significant growth was driven by physicians and hospital systems that increasingly recognize the importance of offering focal one as a cornerstone focal therapy treatment within a comprehensive prostate cancer program. As we continue to expand the clinical applications of FOCA-1 robotic HIFU and bring meaningful value to a broader population of prostate cancer patients, we also remain focused on the significant unmet need in patients who experience recurrence following failed radiation therapy. Radiation therapy failure rates reported in the clinical literature remain significant, and treatment options for these patients are extremely limited. often consisting primarily of hormone deprivation therapy, which can carry debilitating, long-lasting side effects that materially impact a patient's quality of life. Our recent announcement regarding the peer-reviewed publication of the HIFI-2 study further strengthens our global leadership position in focal therapy. This study is significant for several reasons. First, it represents the largest prospective study ever conducted, enrolling more than 500 patients evaluating salvage treatment following recurrence after failed radiation therapy. Second, HIFI-2 is the largest prospective study assessing the use of FOCAL-1 robotic HIFU within this important patient population. Importantly, the study demonstrated clinically meaningful oncologic control with 71% of the overall patient population avoiding hormone deprivation therapy at 30 months. Additionally, in a rigorously selected subgroup of patients, 84% avoided hormone deprivation therapy within the same follow-up time period. These positive results show promise for use of FOCAL1 by 2 as a breakthrough treatment for this important population of men who have previously been left with limited options that result in negative, long-lasting side effects. It is also important to note that the National Comprehensive Cancer Network guidelines already recommend HIFU as a treatment option for patients with prostate cancer recurrence following failed radiation therapy. and both Medicare and commercial payers currently provide reimbursement coverage for the use of Focal 1 robotic HIFU in this clinical setting. In summary, the publication of the HIFI-2 study further reinforces Focal 1's unique position as a non-invasive, organ-sparing, and function-preserving treatment option for a patient population that has historically faced limited therapeutic alternatives beyond palliative care. In urology and moving beyond prostate cancer, we continue to invest in expanded clinical indications for FOCAL1. We are currently accelerating clinical studies evaluating the use of FOCAL1 for the treatment of benign prostatic hyperplasia, or BPH. In early March, our clinical team collaborated with urologists from the New York Icahn School of Medicine at Mount Sinai to treat patients in Chile as part of an ongoing clinical research study. Based on encouraging early outcomes, the trial will continue with plans to enroll and to treat a second cohort of patients over the coming months. In addition, a separate IRB-approved study will be conducted at Mount Sinai in New York, following patient evaluations from the Chile study. Together, these initiatives reflect our broader strategy to expand the clinical utility of FOCAL1 and to further strengthen the body of evidence, supporting its expanded use across additional urologic applications. Within gynecology, our commercial rollout in endometriosis continues to gain momentum across Europe. As mentioned earlier, multiple hospitals have now invested in FOCAL1 robotic HIFU, to support the treatment of both prostate cancer and endometriosis, reinforcing the platform's growing multi-specialty clinical utility. During the quarter, we actively participated in two major scientific meetings, the European Endometriosis Congress and the British Society for Gynecological Endoscopy Annual Scientific Meeting. Our focal one-sponsor symposium at the European Endometriosis Congress in Bologna, Italy attracted more than 400 attendees and generated strong engagement from leading clinicians and specialists across key international markets. On the clinical front, Pras-Rouge Hospital in Lyon, France, remains central to our expansion strategy, serving both as a high-volume treatment center and as our primary physician training hub for endometriosis. In parallel, FOCAL-1 robotic-type endometriosis programs are beginning to launch and enroll patients. We are pleased to confirm that first-patient treatments at several newly established clinical centers are expected to begin in the coming weeks, representing an important milestone as these programs transition from physician training into active clinical adoption. At these recent scientific meetings, investigators also presented positive long-term follow-up data from the Phase II and Phase III randomized controlled trial, demonstrating effective and durable outcomes that remained consistent across all patient cohorts. These findings further reinforce our confidence in the long-term clinical value of this treatment approach. Importantly, we believe the growing body of clinical evidence establishes a strong foundation to support the advancement along the regulatory pathway. Collectively, these commercial and clinical developments further strengthen our conviction that endometriosis represents a significant long-term growth opportunity for focal one. As we mentioned on our last call in March, we collaborated with the leadership team from the NYU Langone Department of Urology to host the inaugural International Symposium on Robotic Focal Therapy in New York City. This event attracted physicians from both the U.S. and international markets who are either developing or actively evaluating focal therapy programs centered around focal one robotic hyphens. The strong attendance and overall success of this educational program further highlights the growing momentum we continue to see throughout the global urology community. Building on the success of the NYU symposium and in response to increasing demand from urologists seeking to integrate focal one technology into their practices, we will be sponsoring a CME accredited physician training course at Memorial Sloan Kettering Cancer Center on Thursday, May 14th. MSKC is ranked as the leading urology-focused comprehensive cancer center in the United States and is a leading and highly experienced user of focal and robotic high food globally. Looking ahead, we will deliver a strong presence at the upcoming annual meeting of the American Urological Association in Washington, D.C., starting on May 15th. The AUA meeting represents the largest global gathering of neurologists and serves as a premier forum where the latest advances in neurology are presented and translated into clinical practice. Throughout the conference, we will host multiple educational and clinical engagement activities, including booth presentations, semi-live focal one procedures, panel discussions, and hands-on focal one simulation sessions led by key clinical thought leaders. In addition, we will be hosting numerous analyst and investor meetings throughout the scientific program. And finally, we are excited to announce that we will host an investor day on June 1st at the NASDAQ market site in New York City. During this event, we will provide important updates on our commercial growth strategy, clinical indication expansion, and product innovation roadmap as we continue to build increased momentum across our business. We believe the opportunity ahead of us has never been greater and we look forward to sharing our vision for the next phase of growth. We hope you will join us in New York. With that, I would now like to turn the call over to Ken to review our financial results. Thank you, Ryan, and good morning, everyone. As a reminder, all figures will now be reported in U.S. dollars. As Ryan mentioned earlier, our record revenue performance for the first quarter of 2026 was driven by continued strength in our core HIFU business, which grew 78% compared to the first quarter of 2025. Growth in our HIFU business was partially offset by expected continued decline in our non-core distribution and ESWL businesses. which declined by 20% in Q1 2026 versus Q1 2025. Total company-wide revenue for the first quarter was $17.8 million, an increase of 25% as compared to total revenue of $14.3 million for the same period in 2025.

Total HIFU revenue for the first quarter was $11.6 million, as compared to $6.5 million for the first quarter of 2025.

The 78% year-over-year increase in HIFU revenue was driven by 11 Focal One capital sales in the first quarter of 2026 versus six capital sales in the prior year period, as well as a 30% year-over-year increase in Focal One treatment-driven revenue. I've mentioned earlier, Local 1 procedures in the U.S. grew 53% year-over-year. Growth profit for the first quarter was $8.1 million compared to $6 million for the prior year period.

Growth margin was 45.7% in the first quarter compared to 42% for the first quarter of 2025.

The 370 basis points increase in gross margin year-over-year was primarily due to a strategic shift to our higher margin high food business segment, which had gross margins of 51.4% for the first quarter compared to 48.6% for the first quarter of 2025. Operating expenses were $15.5 million for the first quarter, compared to $12.3 million for the same period in 2025. The increase in operating expenses was driven by higher sales expense related to increased system sales, as well as incremental costs associated with our transition to a U.S. domestic filer. Operating loss for the first quarter was $7.4 million as compared to $6.3 million in the first quarter of 2025. Net loss for the first quarter was $9.1 million, or $0.24 per share, as compared to a net loss of $7.4 million, or $0.20 per share, in the prior year period. The increase in net loss was driven by incremental operating loss of $1.1 million, as well as a $1.7 million non-cash charge related to warrants and interest expense on the European Investment Bank project drawdown. This was partially offset by 1.1 million positive currency impact versus the prior year period. Turning to the balance sheet, inventory increased $13.3 million at the end of the first quarter, as compared to $12.8 million at the end of Q4 of 2025. This sequential increase in inventory was due to a higher level of HIFU-related inventory to meet the increased demand for Focal One systems as our business momentum continues to grow. Cash and cash equivalents at the end of the first quarter were $15 million, compared to $20.5 million at the end of Q4 2025. The sequential decrease was driven primarily by cash used in operating activities to support our strategic investments in accelerating hypergrowth. Subsequent to the end of the first quarter, on April 20th, we received the second tranche from the European Investment Bank credit facility, totaling approximately $14 million, which will further strengthen our balance sheet and will be reflected in our Q2 financial statements. The tariff impact on the first quarter P&L balance sheet was approximately $400,000. We are reiterating our full year 2026 guidance. We continue to expect core HIFU revenue in the range of $50 to $54 million, representing 34% to 45% growth over 2025, and combined non-core revenue in the range of $22 to $26 million. I will now turn it back to Ryan for closing remarks. Ryan? Thanks, Ken. As we execute through 2026, our priorities remain clear. Commercial execution and continuing to deepen penetration across leading centers. Indication expansion and advancing our endometriosis and BPH programs. Technology and innovation, positioning focal one as a leader in the space with the most advanced robotic focal therapy platform. Q1 was a great start and we are confident in our ability to deliver on our 2026 priorities.

Operator, please open the line for questions.

Thank you. At this time, if you would like to ask a question, please press the star and 1 on your telephone keypad. To leave the queue at any time, press star 2. Once again, that is star and 1 if you would like to ask a question. We'll take our first question from Michael Sarkone with Jefferies. Please go ahead. Your line is now open.

Good morning, and thanks for taking our questions. Just to start, the U.S. high food procedure growth, 53%, really impressive, and that's a nice acceleration. Maybe you can just talk a little bit more about what you're seeing in terms of utilization and what's driving that growth, and then I guess secondly, how sustainable is that level of growth in your opinion?

Yeah, Michael.

So first off, yeah, we had good procedure growth, and again, on a quarter-over-quarter basis, double-digit growth. And so, again, we're seeing increased demand for non-radical treatments, obviously focal therapy being the discussion point. So we see a couple things. One is our install-based customers continue to evolve with their programs, We've expanded training to additional doctors, so that has a direct input to increased volume of procedures. But also, we're getting better at ramping programs. And so, obviously, selling more capital creates more capacity to treat more patients. So I think it's really a culmination of a number of things. I think, you know, the patient audience... As we know, prostate cancer is a heterogeneous cancer. So patients are now doing more research. They're really looking at their options closely. And if they're really not a candidate for radical treatments, then they should ideally be on active surveillance or they should be a target for focal therapy. So we see very good engagement from the centers that have our technology and certainly more centers looking to adopt it. And so, again, I would, you know, we have a dedicated sales force on the clinical side that's doing an excellent job of advancing the programs. And, again, we sell and build our programs. So we feel very confident that we'll continue to grow our procedures. It's a very important metric for us. And, of course, it's important to driving increased margin as well as, you know, overall revenue.

That's helpful. Thanks, Brian. And I guess just to follow up on that, When you think about your U.S. accounts in particular for FOCAL1, I mean, can you give us some sense of, you know, what's the average number of surgeons, you know, using the system at accounts today and maybe talk about how that's evolved over the, you know, the past two quarters?

Yeah, so very good question. So, you know, some of our earlier programs, we had individual surgeons or urologists that throw deals. And, of course, as we described it as a program, a program may involve a number of urologists. So we've moved from kind of that 1.5 number of trained doctors to nearly two per site, two or more. We have some sites where we have as many as six urologists trained to access focal one and more in the queue to be trained in coming quarters and including weeks. So... We're a little more prescriptive now as we've matured in our business. We want to train more urologists. It really depends. It varies by institution, academic centers versus community hospitals. We're in that two or more range is our goal. Certainly, in some instances, as I referenced, we have up to six or seven urologists trained and now starting to access

vocal one so that that's really positive for us and we'll continue to do uh continue to focus on that as we launch new programs all right and if i could just squeeze in one more just you know on the endometriosis side sounds like some really solid momentum overseas i guess just a two-parter here how are you thinking about financial contribution as you start to see you know endometriosis application grow and then Secondly here, you know, any update on what's going on with your U.S. efforts in endometriosis? Thank you.

Yeah, so as we talked about, we had some great wins in the quarter with gynecologists weighing in on endometriosis. So, again, bringing in a second specialty. You know, we're not only a urology company in men's health, but we're also becoming a women's health company. So I think what you're seeing there is certainly more activity on the capital sales side. In the short term, we'll see that. I think we'll see more of that coming because we can do more procedures on the same platform, for one. So it may be too early to say in our models. We'll have more that we can share in future updates of how that may play into the overall revenue number, including recurring revenue, right, on disposables or consumables. As far as the U.S., We, as noted, we're still waiting for published data from the randomized control trial that has now follow-up out to 24 months, coming up on 24 months. And then there was a subset of patients who were part of the sham arm who were treated and were coming up to 12 months follow-up. We're expecting that data to be published likely sometime this year. That data will be very important for us to revisit our strategy with the FDA in the U.S. So the good news is some of this data has been recently discussed and presented at the two meetings I referenced in Europe. and there seems to be very good engagement from the thought leaders who specialize in endometriosis. But when the new data is presented, I think that will be an opportunity, again, to take that, and that will play directly back into the conversations that we'll have with the FDA.

Great.

Thanks, Ryan. Thank you.

Thank you. We'll take our next question from Jason Budnar with Piper Sandler. Please go ahead. Your line is open.

Hey, guys. Good morning. I was actually taking the questions, and congrats on the quarter here. I wanted to start on the Haifu business here in the U.S. Your placements are doing well globally. That's obvious. You put a really good growth here in the quarter. A lot of that can be attributed to this international expansion that you're touching on. I know we're a few years into this more focused commercial initiative around Haifu in the U.S. as well, though. Can you take us around through how you're thinking about the U.S. market? What does that runway look like in the U.S.? ? And when we think about opportunities in high school, are they just simply greater now outside the U.S.? And that's why we're seeing, you know, more emphasis and growth from, again, kind of your ex-U.S. markets.

Yeah, so what, again, we sell what we believe and clearly have demonstrated a clinically necessary strategic revenue-enhancing service line in the number one diagnosed cancer in men. So prostate cancer obviously is an anchor point in men's health. So looking at the system sales, we have a strong pipeline, and that pipeline is building. I think hospitals are also starting to recognize the need to answer to the call of offering focal therapy. Focal therapy is emerging as a treatment category, as we know, but it is a necessity to be a comprehensive offering in a hospital. And we are, you know, looking at our system sales. We're really early in this adoption life cycle. I mean, you know, we're growing here, but the upside is significant for the company in looking at total numbers of potential sales for the future, and I'm talking about the U.S. So, again, we continue to focus on building our active pipelines. As you can see, we continue to sell in academic centers, but also growing more rapidly in community hospitals. And that's important, and we've had some notable wins as we look across our install base. In the outside U.S., I think the important thing to understand is our legacy history in urology, as a company in extracorporeal shockwave lithotripsy, we already have an established sales channel. So now we're fully activating on that sales channel. A number of us came from intuitive surgical, and we know the playbook. And we're applying that playbook like we did back in the early days of radical prostatectomy. And so I think we're seeing those results play out now. So the outside U.S. market continues to gain traction as we continue to move the U.S. market. And to add to that, as we look at our mix for the year, it will still be predominantly in the U.S. when it comes to unit sales. And as a reminder, we sell direct in the U.S., so we can demand a higher ASP both on our system and on our consumable products.

Okay. So just to clarify, Ken, you're saying, you know, embedded in the guidance for the rest of this year, what's implied is that U.S. accounts for a disproportionate amount of the mix of system sales. Correct. Okay. Perfect. Maybe the next one on, you know, Yeah, obviously has the biggest conference coming up here with AUA. Is there anything quantitative you're prepared to talk about in terms of sessions, meetings, exposure? I know, Ryan, you mentioned a lot of those that you have planned, but how this year's conference compares to the last few years as you look to broaden your exposure and deepen your relationships?

Yeah, so a couple of good things for this year. The meeting is in Washington, D.C. next week. And as communicated on the call, we have a course going on with Memorial Sloan Kettering Cancer Center. So that's on the front end of AUA the day before. And then we're going to be directly in Washington, D.C. with the scientific program of AUA. So as we look at it, we will have a very strong showing at this meeting, a lot of busy activity at our booth. We have presentations. We have the ability to do case simulations, which are really important for new customers that get to get on the Focal One platform and go through an actual treatment. They see how easy it is to set up the treatment and what the robotic platform can do for them. Beyond that, I would just say a scattering of different scientific presentations throughout the meeting, abstracts either presented orally or in some of the poster sessions or even some discussion on the growth of focal therapy. I think the biggest thing that we see is focal therapy is becoming more of a household word in the treatment category of prostate cancer. As it continues to evolve, we're in a new era of treatment. So we'll see some of that going on out in the scientific sessions. We have a number of presentations from key thought leaders at our booth. We'll have a dinner event that's already sold out, and we're excited about that. That will be on Saturday night. So we'll have a lot of great activity, and, of course, we have a very large booth in the main focused area of the exhibit hall. While we're there, we're entertaining a number of discussions with key investors and key analysts. We believe we're a breakout story, so we want to have those conversations and continue the momentum we're building.

All right, very good. Last one for me, and maybe just shortly after the EUA, you've got your investor day coming up. Should we be prepared for a long-range plan at the investor day? Is that something you're going to be prepared to discuss?

Yeah, on our investor day, really, we're really at an inflection point of our business. So we want to provide a number of key updates. So there will be some updates on our financial models. We'll be talking about kind of the wraparound or commercial strategy. Of course, we'll be talking about some of the new indications and what we're focusing on there. And I think there will be a technology element, something we haven't discussed or shown before, that will be of interest to all attendees. We're investing in some new innovations as it relates to Focal 1, but even beyond Focal 1. So I think there will be a lot there for people to learn and understand, and we look forward to sharing those updates accordingly. All right. Thank you very much. Thank you.

Thank you. At this time, there are no further questions. I will now turn the meeting back to Ryan Rhodes.

As discussed on this quarter's call, Focal One Robotic Haiku continues to emerge as a market-leading focal therapy technology being adopted by more and more physicians and hospitals around the world. VolcaOne requires no surgery, cutting, or use of radiation, thus allowing physicians to perform a non-invasive, precise, robotic-targeted ablation that treats only the intended disease areas while preserving the patient's healthy tissue.

Its focus as an organ-sparing, function-preserving treatment aligns with the direction of modern medicine. Importantly, FOCA-1 is not just a device.

It's a foundation of program building within healthcare institutions. We believe this multi-specialty, multi-indication strategy positions us well for sustained growth and long-term value creation. I want to thank everyone for joining us on today's call. We look forward to seeing you at the upcoming annual meeting of the American Neurological Association next week. and at our Investor Day and the Jeffries Healthcare Conference, both taking place in New York City in early June.

Thank you.

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.