EDAP

Welcome to the EDAP 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 François 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 One 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 first 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 One 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 in growing visibility of our Focal One pipeline. In the quarter, we continued to expand 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 10th Focal One system installed in the state of Florida.

These placements further validate Focal One's emergence as a leading robotic focal therapy platform being adopted and utilized by top-ranked institutions nationwide. We also placed a second Focal One 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 HIFU 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 Insurance's decision to provide universal coverage for the Focal One HIFU procedure.

As a reminder, this coverage decision was supported by results from the landmark HIFI study, a large prospective comparative trial that demonstrated positive efficacy outcomes for Focal One robotic HIFU as compared with radical prostatectomy in the treatment of prostate cancer. This quarter also marked the first time our Focal One capital sales were driven by demand across two clinical indications: prostate cancer and deep infiltrating endometriosis. Further highlighting the value of Focal One as both a multi-specialty and multi-indication treatment platform. In the U.K., 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 Focal One robotic HIFU for the treatment of both prostate cancer and endometriosis.

In Eastern Europe, we achieved our first Focal One 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 Focal One 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 Focal One 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.

HIFI-2 is the largest prospective study assessing the use of Focal One 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 Focal One HIFU 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 One robotic HIFU in this clinical setting.

In summary, the publication of the HIFI-2 study further reinforces Focal One'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 Focal One. We are currently accelerating clinical studies evaluating the use of Focal One for the treatment of benign prostatic hyperplasia, or BPH. In early March, our clinical team collaborated with urologists from the 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 Focal One 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 Focal One 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 Gynaecological 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, Hôpital Edouard Herriot 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 One robotic HIFU 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 Health 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 HIFU. 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 One robotic HIFU 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 urologists and serves as a premier forum where the latest advances in urology 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. 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. 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. As mentioned earlier, Focal One procedures in the U.S. grew 53% year-over-year. Gross profit for the first quarter was $8.1 million compared to $6 million for the prior year period. Gross 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 the strategic shift to our higher margin HIFU 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 tranche A 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 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. This sequential decrease was driven primarily by cash used in operating activities to support our strategic investments in accelerating HIFU growth. 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 and 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 million-$54 million, representing 34%-45% growth over 2025, and combined non-core revenue in the range of $22 million-$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. 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 one on your telephone keypad. To leave the queue at any time, press star two. Once again, that is star and one if you would like to ask a question. We'll take our first question from Michael Sarcone with Jefferies. Please go ahead. Your line is now open.

Good morning, thanks for taking our questions. Just to start, the U.S. HIFU 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. I guess secondly, how sustainable is that level of growth in your opinion?

Yeah, Michael. First off, yeah, we had good procedure growth and again, on a quarter-over-quarter basis, double-digit growth. Again, we're seeing increased demand for non-radical treatments, obviously focal therapy being the discussion point. We see a couple things. One is our install base 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. Also, we're getting better at ramping programs, obviously selling more capital creates more capacity to treat more patients. 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.

If they're really not a candidate for radical treatments, they should, you know, ideally be on active surveillance, or they should be a target for focal therapy. We see very good engagement from the centers that have our technology and certainly more centers looking to adopt it. 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. Again, we sell and build a program. We feel very confident that we'll continue to grow our procedures. It's a very important metric for us. Of course, it's important to driving increased margin as well as, you know, overall revenue.

That's helpful. Thanks, Ryan. I guess just to follow up on that, when you think about your U.S. accounts in particular for Focal One, 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? Maybe talk about how that's evolved over the, you know, the past few quarters.

Yeah. A very good question. You know, some of our earlier programs, we had individual surgeons or urologists that drove deals. Of course, as we described it as a program, a program may involve a number of urologists. We've moved from kind of that, you know, 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. We're a little more prescriptive now as we've matured in our business. We wanna train more urologists. It really depends, you know, it varies by institution, you know, academic centers versus community hospitals.

We're, you know, we're in that kinda 2% or more range, is our goal. Certainly, in some instances, as I referenced, we have up to 6% or 7% urologists trained and now starting to access Focal One. That's really positive for us. We'll 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? Secondly here, you know, any update on what's going on with your U.S. efforts in endometriosis? Thank you.

As we talked about, we had some great wins in the quarter with gynecologists weighing in on endometriosis. 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. 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, Focal One. 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. There was a subset of patients who are 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. The good news is some of this data has been recently discussed and presented at the two meetings I referenced in Europe. There seems to be very good engagement from the thought leaders who specialize in endometriosis.

When the new data is presented, I think that'll 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 Bednar with Piper Sandler. Please go ahead.

Hey, guys. Good morning. Thanks for taking the questions, and congrats on the quarter here. Wanted to start on the HIFU business here in the U.S. Your placements are doing well globally. That's obvious. You put up really good growth here in the quarter. A lot of that, though, 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 HIFU in the U.S. as well, though. Can you take us around, you know, through how you're thinking about the U.S. market? What does that runway look like in the U.S.? When we think about opportunities in HIFU, are they just simply greater now outside the U.S. and that's why we're seeing, you know, more emphasis in growth from, again, from kind of your ex-U.S. markets?

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. Prostate cancer obviously is an anchor point in men's health. 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. We are, you know, looking at our system sales, we're really early in this adoption life cycle.

I mean, 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. 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. That's important, and we 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 Shock Wave Lithotripsy, we already have an established sales channel. 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. I think we're seeing those results play out now. The outside U.S. market continues to gain traction as we continue to move the U.S. market. 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. 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. Just to clarify, Ken, you're saying that, 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 next one on, you know, you obviously have 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. 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. That's on the front end of AUA the day before, and then we're gonna be directly in Washington, D.C. with the scientific program of AUA. 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 there are 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. 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'll be on Saturday night.

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, we want to have those conversations and continue the momentum we're building.

All right, very good. Last one from me. Maybe just shortly after AUA, 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 gonna be prepared to discuss?

At our Investor Day, really, we're really at an inflection point of our business. We want to provide a number of key updates. There will be some updates on our financial models. We'll be talking about kind of the wrap around our commercial strategy. Of course, we'll be talking about some of the new indications and what we're focusing on there. I think there'll 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 One, but even beyond Focal One. I think there'll 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 HIFU continues to emerge as a market-leading focal therapy technology being adopted by more and more physicians in hospitals around the world. Focal One 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, Focal One 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 wanna thank everyone for joining us on today's call.

We look forward to seeing you at the upcoming annual meeting of the American Urological Association next week and at our Investor Day and the Jefferies 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.

Greetings, and welcome to the EDAP TMS Fourth Quarter and Year-End 2025 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. Thank you. You may begin.

Good morning. Thank you for joining us for the EDAP TMS Fourth Quarter and Full Year 2025 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 annual report on Form 10-K for the year ended December 31, 2025, to be 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 under Regulation FD. I would now like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes. Ryan?

Thank you, Louisa, and good morning, everyone. 2025 was a transformative year for our company, highlighted by 39% revenue growth in our core HIFU business and record commercial performance for Focal One. Importantly, much of this growth was driven by accelerated adoption in the U.S., where we delivered record system placements and strong procedure growth. As our installed base continues to expand, we are also seeing increased utilization across hospitals, emphasizing the positive recurring revenue opportunity created by each Focal One system placement. Today, we will begin with our fourth quarter results, then reflect on our achievements, including our financial performance, and we will close the call by outlining our strategic priorities for 2026. The fourth quarter was the strongest quarter in the company's history for HIFU revenue, representing an increase of 34% over the same period last year. This growth was led by capital sales and treatment-driven revenues, which continue to be the driving force of our ongoing commercial success. We achieved a record 15 Focal One placements worldwide, including 14 cash sales, representing our strongest quarter-to-date in both placements and cash sales. Performance was driven by the U.S. market, which delivered 10 cash sales, its highest quarterly total on record. Beyond the headline numbers, the profile of our customers continues to be led by the expanding adoption of Focal One amongst leading academic centers in major community hospitals. Notably, we achieved our first Focal One placement in the state of Wisconsin at Aurora St. Luke's Medical Center, part of Advocate Health, a major integrated health care delivery network spanning 18 hospitals across the states of Wisconsin and Illinois. In total, we achieved 4 new Focal One placements in the state of Pennsylvania during the quarter, further strengthening our presence in this region. The University of Pennsylvania, a member of the National Comprehensive Cancer Network and a National Cancer Institute designated Comprehensive Cancer Center, converted their existing HIFU program to Focal One. With the addition of University of Pennsylvania, Focal One now has been adopted by 55% of NCCN member institutions. The University of Pittsburgh Medical Center, UPMC, a Society of Urologic Oncology Approved Fellowship program was also added to our Focal One installed base this quarter, bringing our penetration to 63% of the prestigious SUO group of teaching hospitals in the U.S. Of noted importance after the recent placements at 2 additional Cleveland Clinic hospitals in the U.S. during the fourth quarter, there are now 5 Focal One systems within the global Cleveland Clinic Hospital network. As hospitals see increasing patient demand, they are expanding across multiple locations. We now have 10 leading U.S. health care systems with 2 or more Focal One programs. We also continue to see existing competitive HIFU programs converting to Focal One technology. During the quarter, 3 major focal therapy programs converted from use of legacy HIFU technology to Focal One, including the University of Pennsylvania, Penn State Health as well as Lakewood Ranch Medical Center in Florida. Notably, at Lakewood Ranch Medical Center, Dr. Stephen Scionti, a high-volume focal therapy expert, has transitioned to the Focal One i platform. Dr. Scionti is widely recognized as one of the most experienced HIFU experts in the U.S., having treated 2,000 prostate cancer patients in over 20 years using a legacy HIFU platform. His decision to adopt our latest technology further validates our strategy of ongoing innovation and reflects Focal One i's advanced imaging and robotic precision. Internationally, our Focal One capital sales momentum also continues to expand in existing regions as well as new emerging markets. During the quarter, we achieved 4 cash sales outside the U.S., including the first Focal One system in India and the first Focal One system in Argentina. The sale to Ruby Hall Clinic, a top-tier institution in Pune, India, represents a key commercial milestone in a large and underpenetrated market. Additionally, the sale at the Argentinian Institute of Diagnostics and Treatment in Buenos Aires expands our South American footprint, adding to other existing Focal One sites in Brazil and Chile. Finally, our momentum continues to build across Southern Europe with additional new Focal One system sales in both Italy and Spain. While we were encouraged by this strong momentum, we believe we are early in the overall adoption life cycle of Focal One Robotic HIFU in this large and growing addressable market. Turning our attention to utilization. U.S. Focal One procedure volumes reached the highest quarterly level, growing 28% as compared to Q4 2024. This procedure growth is driven by a combination of newly launched programs as well as increased patient demand with existing programs. This was consistent across the different geographic market segments to include hospitals in large metropolitan statistical areas as well as hospitals in smaller communities. Complementing our commercial success, we achieved an important regulatory milestone during the fourth quarter. On November 20, we received FDA clearance for the latest evolution of Focal One Robotic HIFU, introducing advanced ultrasound imaging and streamlined treatment planning. This next-generation ultrasound imaging engine provides real-time visualization and supports the future development of AI-driven algorithms designed to assist surgeons with tissue ablation visualization and treatment evaluation. These combined advancements along with the launch of Focal One i earlier in 2025, further strengthens our leadership position in focal therapy while providing incremental sales momentum into 2026. Turning our attention to reimbursement. The landscape continues to move in a favorable direction for Focal One. TMS finalized the 2026 outpatient prospective payment system rule awarding a national facility payment average of $9,671, representing a 4.6% increase versus 2025. This new rate went into effect January 1. As it relates to the physician payment, Focal One is also supported by favorable economics. In the 2026 final rule of the physician fee schedule, TMS has set the total facility RVUs at 26.33 for the HIFU procedure. This compares favorably to alternative ablative treatments for prostate cancer for a single urologist under the same setting and patient conditions. In short, the Focal One HIFU procedure provides a physician from 28% to 67% higher RVUs than an alternative ablative treatments in 2026. Beyond prostate cancer, we continue to advance our clinical strategy to expand new indications with use of the Focal One Robotic HIFU platform. As endometriosis awareness month comes to a close here in March, we continue our commitment to advance new innovative treatment options while raising visibility on the unmet need for a new noninvasive treatment option for women suffering from this highly debilitating condition. Claude University Hospital in Lyon, France is treating patients and hosting training programs for leading European endometriosis specialists, including physicians from Cleveland Clinic London, who recently observed Focal One procedures. Regarding BPH, our combined Phase I/II study continues in Europe according to our outlined protocol. Simultaneously, we initiated a new clinical trial in South America in collaboration with the Mount Sinai Health System in New York with several patients already treated in early March by a team of local and U.S. BPH experts. This represents another positive step towards broadening the addressable market for use of Focal One Robotic HIFU. Transitioning to surgeon education, our activities continue to build growing awareness across the urological community. We recently attended the 41st Annual Congress of the European Association of Urology in London, U.K. This is the second largest scientific meeting dedicated to urology in the world with more than 12,000 attendees from 124 countries. In front of this year's EAU meeting, we collaborated with Cleveland Clinic London to host a sold-out urology peer-to-peer educational event dedicated to learning and understanding the clinical value and applications delivered by Focal One Robotic HIFU in the treatment of prostate cancer. This coming weekend, the world-renowned urology team at NYU Langone in New York City, we will host the first international symposium on robotic focal therapy. This large inaugural event entirely dedicated to Focal One will offer attendees lectures, hands-on training, detailed video case reviews and semi-life Focal One procedures led by top U.S. and international experts. I will now turn the call over to Ken, who will review our financial results.

Thanks, Ryan, and good morning, everyone. Before I begin, I want to note that all 2025 figures are reported in euros, our functional and reporting currency. For conversion purposes, our average euro-dollar exchange rate was $1.16 for the fourth quarter 2025. Beginning with our Q1 2026 results, we will report in U.S. dollars, reflecting our transition to a domestic issuer. Turning to full year 2025 performance. EDAP set a calendar year record for HIFU revenue in 2025. HIFU revenue for the full year 2025 was EUR 33.1 million, an increase of 39% as compared to HIFU revenue of EUR 23.8 million for the full year 2024. The increase in HIFU segment revenue versus the prior year was due to a 59% increase in the number of Focal One system units sold and a 19% year-over-year increase in treatment-driven revenue. Total revenue for full year 2025 was EUR 62.4 million, a decrease of 3% compared to EUR 64.1 million for the full year 2024. The year-over-year decrease was driven by a 27% decline in our noncore distribution and ESWL businesses, which offset the 39% growth in core HIFU business, as I just outlined. This is consistent with our strategy of focusing resources on the higher-margin HIFU business while managing the legacy businesses through their natural decline. Now turning to the fourth quarter. Q4 2025 was a record quarter for HIFU revenue. HIFU revenue was EUR 11.7 million, a notable increase of 34% as compared to HIFU revenue of EUR 8.8 million for the same period in 2024. The increase in revenue was due to continued significant strength in our Focal One HIFU business driven by 14 Focal One capital sales in the quarter versus 11 capital sales in the prior year period as well as a 22% year-over-year increase in Focal One treatment-driven revenue. As mentioned earlier, Focal One procedures in the U.S. grew 28% year-over-year. Total revenue for the quarter was EUR 18.9 million, a decrease of 7% compared to EUR 20.3 million for the same period in 2024. The decrease was primarily driven by a 38% decline in our noncore distribution and ESWL businesses in the quarter versus Q4 2024, offsetting the 34% year-over-year growth in HIFU business. We continue to expect our noncore segments to decline as a percentage of total revenue over time, consistent with our strategic focus. Regarding gross margin, gross margin for the quarter was EUR 8.1 million compared to EUR 9.1 million for the same period in 2024. Gross margin on net sales was 42.6%, down from 44.8% for the same period in 2024. This decline was primarily driven by 2 items: tariffs on imports of finished goods from France and an inventory reserve related to legacy parts. Excluding these items, underlying gross margin performance was in line with the prior year. We continue to actively monitor the tariff environment. Operating expenses were EUR 13.2 million for the quarter compared to EUR 12.8 million for the same period in 2024. The increase in operating expenses was primarily due to focused investments in our HIFU business. Operating loss for the quarter was EUR 5.2 million compared to an operating loss of EUR 3.7 million in the fourth quarter of 2024. Net loss for the quarter was EUR 8.2 million or EUR 0.22 per share as compared to a net loss of EUR 1.9 million or EUR 0.05 per share in the same period a year ago. The increase was driven by 2 items below the operating line, a EUR 2.5 million noncash charge related to warrants and interest expense on the European Investment Bank Tranche A drawdown and a EUR 2 million negative currency impact versus the prior year period. Turning to the balance sheet. Inventory decreased to EUR 10.9 million at quarter end as compared to EUR 13.8 million at the end of Q3. This reduction was driven by the high volume of capital system sales in the quarter and disciplined inventory management. Total cash and cash equivalents were EUR 17.4 million at quarter end, up from EUR 10.6 million at the end of Q3, primarily reflecting the EIB Tranche A drawdown. Finally, on to our 2026 outlook. As previously announced in January, we expect core HIFU revenue to be in the range of USD 50 million to USD 54 million, representing 34% to 45% growth over 2025. Combined noncore revenue is expected in the range of USD 22 million to USD 26 million. This guidance reflects our confidence in the capital placement momentum Ryan described, our expanding installed base and the continued ramp of procedure volumes across our growing network of Focal One programs. I would like to now turn the call back to Ryan for closing comments.

Thanks, Ken. In closing, 2025 was a year of record performance, expanding clinical validation and technological advancement. As we enter 2026 with accelerating commercial momentum, we are executing with discipline against 3 high-impact priorities designed to drive durable growth and long-term shareholder value. First, commercial execution. We are expanding our penetration across leading academic centers, community hospitals and integrated delivery networks with significant runway ahead as we remain early in the adoption life cycle of this large underpenetrated market in prostate cancer. Second, clinical indication expansion. Beyond prostate cancer, we are unlocking incremental growth opportunities for Focal One across new indications. We are making meaningful progress on our BPH clinical and regulatory pathway and accelerating commercialization in endometriosis. Third, technology and innovation. We are advancing AI-driven treatment planning and next-generation imaging capabilities to strengthen Focal One's leadership as the most advanced robotic focal therapy platform in the market. The combination of these priorities, commercial execution, indication expansion and continued technology innovation and leadership underpins our confidence in our 2026 outlook and beyond. In closing, we are confident in our ability to deliver sustainable growth and create long-term shareholder value. With that, I will now turn the call back over to the operator for questions. Operator?

[Operator Instructions] We'll take our first question from Mike Sarcone with Jefferies.

I guess just to start, can you give us a little more color? I know you're reiterating the 2026 guidance, but particularly on the HIFU side, any color on kind of splitting out growth in procedures versus capital sales would be helpful.

Yes, Michael. So again, we see pipelines building and being strong both in the U.S., but importantly, also in the outside U.S. markets. We continue to execute around global regions. So as we've talked about in the past, pipeline development and a growing pipeline in the U.S., but equally in the outside U.S., and some of that was demonstrated certainly with our results here at the end of the year as -- and we're already into 2026. Procedure growth, again, we saw a notable increase Q4, 28% over prior year. We see double-digit growth from quarter-to-quarter if we measured ourselves Q4 versus Q3 of last year. And I think we're, again, seeing more and more centers actively looking to expand to a broader audience of patients. Again, each program ramps differently. But I think overall, we look outward and see a strong year for us, both in terms of capital sales as well as procedure growth.

And Michael, as we move forward to, as Ryan referenced, with 35 Focal One sales in 2025, that is going to lead down the road to procedure growth as well as service growth when those expire. With our installed base now at 165 units, that's also going to lead to disposable sales growth and service growth as well. Capital sales will lead the way again on a percentage basis, but we do see the procedure and service revenue volumes picking up as a total percentage of revenue for HIFU.

Great. That's all very helpful. And then maybe just my follow-up. What have you seen so far 1Q to date in terms of procedures in the U.S. and globally? And particularly in the U.S., have you seen any impact from some of the storms in the Northeast and along the East Coast?

No impact that I can point to. I would say, generally, we see a nice ramp developing. We came off of Q4, a strong quarter. But again, Q1 is ramping as planned. Nothing holding us back from growing appropriately per the guidance we've given in procedure growth and revenue.

We will move next to Joseph Downing with Piper Sandler.

Yes. So I guess the HIFU guide was reiterated here. And I'm just thinking how should investors be thinking about the first half, second half split within the HIFU guide given the seasonality with 4Q? And then specifically, what's a reasonable baseline for 1Q HIFU revenue given typical hospital CapEx sensitivity? And then just at a higher level, are you embedding any cushion for lumpiness throughout the year of the capital sales line? Do you think that should kind of flatten out a little bit over the course of this year? Or should we expect more of the similar from the previous few years there?

Yes. So thanks for the question. So when we look at this year's revenue 2026, we're going to see the following patterns, very consistent with prior years. We anticipate Q4 to be the highest growth quarter, revenue-wise and our biggest dollar-wise quarter. And the lowest quarter will be in Q3. That's very consistent with Q4 capital budgets spending and Q3 summer slowdowns. So we see a little less than 50% of the business in the first half of the year, and I'd say a little more on the second half.

Great. I appreciate that, Ken. And then just on the noncore wind-down trajectory, obviously, implies another step down from last year's figure in 2026. Curious if you could just break out how much of that is ESWL versus the distribution business? And then at what point does noncore revenue effectively reach a de minimis level? I guess, said a little differently, when does the revenue mix shift kind of become clean enough that investors should evaluate EDAP purely on HIFU metrics?

Yes. So when you look at the noncore, ESWL is roughly 20% to 25% of the noncore okay? And the way we're looking at the business going forward is as follows, okay? Our ESWL business now is service-only business, okay? So we're going to continue to serve that and look at ways to monetize that business. And the way to look at the distribution business going forward, it's just like I explained last year. When these agreements expire, our annual distribution agreements, we're taking a look at each agreement. Is it material to revenue and is it accretive to gross margin? And then we're making executive decisions on should we ramp that business going forward. So I would still see that business sticking around in the short term.

Our next question comes from Swayampakula Ramakanth.

This is RK from H.C. Wainwright. A couple of quick questions for me. The first one being on the margins, you cited a normalized margin of 46.9%. I understand some of that is being hit by the Section 232 tariff stuff. What percentage of your revenue gets impacted by that? And then what's the strategy going forward if this -- if there is stickiness to that 232 tariffs?

Yes. So RK, as you know, we manufacture our product in Lyon, France. So the pieces of the business that are impacted are when we ship the finished goods from Lyon, France to the United States. So it's basically our U.S. revenue that's an impact to those dollars today. We're monitoring the situation closely. We have budgeted about $2.5 million in tariffs in 2026 to be conservative, and we're just going to continually monitor what everything is happening from the government regarding those. The offset to the tariff is we do have our new ultrasound engine. As we anticipated and told you last year, we were transitioning to this engine. It's going to have better functionality and also lower cost. So that will help offset some of the tariff impact.

Okay. Then Ryan, just about a high-level thought here. I know for quite a bit of '24 and the early part of '25, you are concerned about cash sales. You closed out 2025 with 14 cash sales and 1 lease. So does that mean some of those concerns regarding cash sales have mitigated quite a bit. And so you're comfortable going into '26. And also, if there was any price increase taken in early part of 2026, just trying to understand what could be the potential levers or the full push on the revenue guidance that you just gave us?

Yes, RK. So again, as I tell people, we sell a clinically necessary strategic revenue-enhancing service line in the #1 diagnosed cancer in men. So it puts us in a position to be strategic in nature. And with that, hospitals need to invest in the technology, and that means purchase the technology. So we've been leading with the cash sale. We believe our platform is best-in-class in the market. It brings immediate tangible value when we launch our programs. So a cash sale makes total sense, plus the reimbursement that's in place today. So cash sales will be our lead theme going forward. In the past, we have offered some time-based operational leases or bridge to budget or bridge to purchase. We don't need to do that as much anymore. I think people realize that Focal One is a key anchor point to their overall focal therapy program. So we showed excellent sales and cash sales here in Q4. Our theme going forward will be leading with cash sales as notably. In terms of a price increase, we took a price increase last year with the launch of Focal One i. And as you heard in the past, we made notable advancements in this new platform, both hardware and software. And we're not done. We will continue to innovate on the platform. We've made improvements in a number of areas, and we're never satisfied. So we have a price increase that went in place last year. We haven't changed our pricing strategy at the beginning of this year, and we see our average selling prices tend to hold or even slightly increase. So I'm proud of the work our commercial teams are doing in the field.

And at this time, there are no further questions in queue. I will turn the meeting back to Ryan Rhodes for closing remarks.

I want to thank everyone again for joining us on today's call. We look forward to seeing you in Washington, D.C. at the upcoming Annual Meeting of the American Urological Association in May and our important Investor Day being held in New York City on June 1, along with the Jefferies Healthcare Conference also taking place in New York City at the beginning of June. Thank you, everyone.

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