EDAP TMS S.A.

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© transcript Emily Beynon

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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 CMS 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 factor section of our annual report on Form 10-K for the year ended December 31st, 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 FT. I would now like to turn the call over to EDAP's Chief Executive Officer, Brian Rhodes. Brian?

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 1. 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 and 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 healthcare delivery network spanning 18 hospitals across the states of Wisconsin and Illinois. In total, we achieved four new FOCA I 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-1. With the addition of the University of Pennsylvania, Focal-1 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-1 install base this quarter. bringing our penetration to 63% of the prestigious SUO group of teaching hospitals in the US. Of noted importance after the recent placements at two additional Cleveland Clinic hospitals in the US during the fourth quarter, there are now five focal one systems within the global Cleveland Clinic hospital network. As hospitals see increasing patient demand, spanning across multiple locations. We now have 10 leading U.S. healthcare systems with two or more Focal One programs. We also continue to see existing competitive HIFU programs converting to Focal One technology. During the quarter, three 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 Scianti, a high-volume focal therapy expert, has transitioned to the Focal1i platform. Dr. Scianti 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 Eye'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 four 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 under-penetrated 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 1 system sales in both Italy and Spain. While we were encouraged by this strong momentum, we believe we are early in the overall adoption lifecycle of Focal 1 robotic HIFU in this large and growing addressable market. Turning our attention to utilization. U.S. FOCA-1 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 20th, we received FDA clearance for the latest evolution of Focal-1 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 FOCAL1i 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 FOCAL1. CMS 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 1st. As it relates to the physician payment, FOCAL 1 is also supported by favorable economics. In the 2026 Final Rule of the Physician Fee Schedule, CMS 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-1 HIFU procedure provides a physician from 28% to 67% higher RBUs than alternative ablative treatments in 2026. Beyond prostate cancer, we continue to advance our clinical strategy to expand new indications with use of the Focal-1 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 non-invasive treatment option for women suffering from this highly debilitating condition. Croix-Rouge 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 1-2 study continues in Europe according to our outline 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, UK. 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-1 robotic HIFU in the treatment of prostate cancer. This coming weekend, the world-renowned urology team at NYU Langone in New York City 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-live focal one procedures led by top US 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 33.1 million euros. an increase of 39% as compared to HIFU revenue of 23.8 million euros 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 62.4 million euros, a decrease of 3% compared to 64.1 million euros for the full year 2024. The year-over-year decrease was driven by a 27% decline in our non-core 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 11.7 million euros, a notable increase of 34% as compared to HIFU revenue of 8.8 million euros 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 18.9 million euros, a decrease of 7% compared to 20.3 million euros for the same period in 2024. The decrease was primarily driven by a 38% decline in our non-core distribution and ESWL businesses in the quarter versus Q4 2024, offsetting the 34% year-over-year growth in Haifu businesses. We continue to expect our non-core 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 8.1 million euros, compared to 9.1 million euros 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 two 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 13.2 million euros for the quarter compared to 12.8 million euros for the same period in 2024. The increase in operating expenses was primarily due to focus investments in our HIFU business. Operating loss for the quarter was 5.2 million euros compared to an operating loss of 3.7 million euros in the fourth quarter of 2024. Net loss for the quarter was 8.2 million euros, 4.22 euros per share as compared to a net loss of 1.9 million euros, or 0.05 euros per share, in the same period a year ago. The increase was driven by two items below the operating line, a 2.5 million euro non-cash charge related to warrants and interest expense on the European Investment Bank tranche A drawdown, and a 2 million euro negative currency impact versus the prior year period. Turning to the balance sheet. Inventory decreased to 10.9 million euros at quarter end as compared to 13.8 million euros 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 17.4 million euros at quarter end, up from 10.6 million euros at the end of Q3, primarily reflecting the EIB tranche A drawdown. Finally, onto our 2026 outlook. As previously announced in January, we expect core HIFU revenue to be in the range of 50 million to 54 million US dollars, representing 34% to 45% growth over 2025. Combined non-core revenue is expected in the range of 22 million to 26 million US dollars. 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 Fulcrum 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 advancements. As we enter 2026 with accelerating commercial momentum, we are executing with discipline against three 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 lifecycle of this large under-penetrated market in prostate cancer. Second, clinical indication expansion. Beyond prostate cancer, we are unlocking incremental growth opportunities for VOC1 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 ones 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?

Thank you. If you would like to ask a question, please press star 1 on your keypad. To leave the queue at any time, press star two. Once again, to ask a question, please press star and one. And we will pause for a moment to allow everyone a chance to join the queue. We'll take our first question from Mike Sarkone with Jefferies. Please go ahead, your line is open.

Hey, good morning, and thanks for taking the questions. 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.

Yeah, 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, 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... 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 install 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 in one queue 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. You know, 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.

Great. Thank you. Thank you.

Thank you. We will move next to Joseph Downing with Piper Sandler. Please go ahead. Your line is open.

Hey, guys. Good morning. Thanks for taking the questions.

Yeah, 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, you know, given the seasonality with 4Q and And then specifically, what's the reasonable baseline for one QHIFU revenue given typical hospital capex sensitivity? And then just at a higher level, are you embedding any cushion for, you know, 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 similar from the previous few years there?

Yeah, 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 ending 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 non-core wind-down trajectory, obviously implies another step down from last year's figure in 2026. I'm curious if you can just break out how much of that is ESWL versus the distribution business. And then at what point does non-core revenue effectively reach the de minimis level, I guess, When does the revenue mix shift kind of become clean enough that investors should evaluate EDAB purely on HIFU metrics? Thanks.

Yeah, so when you look at the non-core, ESWL is roughly 20% to 25% of the non-core. Okay? And the way we're looking at the business going forward is as follows. Our ESWL business now is service-only business. 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, you know, executive decisions on should we ramp that business going forward. So I would still see that, you know, business sticking around in the short term.

Great. Appreciate that. Thank you, guys. Thank you.

Thank you. Our next question comes from Sohyang Kapula, Ramanath. Please go ahead. Your line is open.

Hello. This is RK from Hitsi Vendrede. Good morning, Ryan and Ken. A couple of quick questions for me. The first one being on the margins. You know, you cited a a normalized margin of 46.9%. I understand some of that is, you know, being hit by the Section 232 tariff stuff. What percentage, you know, of your revenue gets impacted by that? And then, you know, what's the strategy going forward if they're sticking us to that 232 tariffs?

Yeah, 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 good from Lyon, France to the United States. So it's basically our U.S. revenue that's impacted 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, you know, 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 were concerned about cash sales. You know, you closed out 20 to 25. with 14 cash sales and one 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, you know, just Just trying to understand what could be the potential levers or the pull push on the revenue guidance that you just gave us.

Yeah, RK. So again, as I tell people, we sell a clinically necessary strategic revenue enhancing service line in the number one diagnosed cancer in med. 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 1i. 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 into place last year. We haven't changed our pricing strategy 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.

Great. Thank you very much.

Thanks for taking my questions. Thank you.

Thank you. 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 1st along with the Jeffries Healthcare Conference. also taking place in New York City 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.