EDAP at Jefferies Conference: Strategic Expansion in Healthcare

EDAP TMS SA (NASDAQ:EDAP) presented at the Jefferies London Healthcare Conference 2025 on Tuesday, 18 November 2025, focusing on its leadership in therapeutic ultrasound. The company highlighted its innovative Focal One HIFU platform, aiming for growth in urology and expanding into new indications. While the outlook was optimistic, challenges with payer reimbursement were acknowledged.

Key Takeaways

• EDAP is focusing on the Focal One HIFU platform for prostate cancer and benign diseases.
• Gross margins improved to 43% in Q3, driven by a focus on higher-margin HIFU business.
• The company is expanding into new markets like BPH and endometriosis with ongoing clinical trials.
• EDAP aims to capitalize on the projected doubling of prostate cancer cases by 2040.
• Strategic disinvestment from non-core businesses to enhance profitability.

Financial Results

• Gross margins increased from 39.4% to 43% in Q3.
• Focus on the HIFU business to improve margins and achieve profitability.
• Disinvestment from non-core businesses such as distribution and ESWL.

Operational Updates

• Nearly 80 Focal One systems installed globally, including top cancer hospitals.
• Focal One procedure growth showed a 67% CAGR and 15% quarter-over-quarter growth.
• BPH study started in Europe; IRB approval received for a study at Mount Sinai, New York.
• CE mark received for treating stage four endometriosis, with a limited launch in Europe.

Future Outlook

• Prostate cancer cases are expected to double to 2.9 million by 2040.
• A proposed 5.6% increase in reimbursement in the U.S., with final rules anticipated soon.
• First BPH patients to be treated under the IRB protocol at Mount Sinai by year-end.
• FARP trial results expected within the next six months.

Q&A Highlights

• EDAP is in the early adoption phase of Focal One, according to the "Crossing the Chasm" model.
• Addressing payer incidents, especially with Medicare Advantage plans.
• Focal One offers a non-surgical approach to BPH, with outpatient procedure times of 40-60 minutes.
• Focus on treating stage four endometriosis, providing alternatives to morbid surgical procedures.

Readers are encouraged to refer to the full transcript for a detailed understanding of EDAP's strategic direction and market positioning.

Full transcript - Jefferies London Healthcare Conference 2025:

Matthew Asperall, Equity Research, Jefferies: All right, good afternoon. My name is Matthew Asperall. I'm with our U.S. MedTech Equity Research team here at Jefferies. With us, we have Ryan Rhodes, the CEO, and Ken Mobeck, the CFO of EDAP. We're going to kick it off with a quick presentation and then some Q&A.

Ryan Rhodes, CEO, EDAP: Great, thank you. Glad to be here and excited to update you on the company and our progress. EDAP Focal One is a global leader in therapeutic ultrasound for the treatment of cancer and benign disease. We are driven by our HIFU platform, Focal One, or shown here, our Focal One Eye platform, which we launched this year in May as an improvement to our prior platform, Focal One. This is the most advanced robotic HIFU platform in the market today, and it incorporates a number of key features and elements, which I'll walk through in this video.

Focal One is a robotic HIFU platform designed for urologists to perform focal ablation of prostate tissue. It combines all the latest innovations in imaging, robotics, and HIFU technologies to offer a precise and user-friendly tool in the hands of the urologist. The endorectal probe and robotic positioning system are unique to Focal One. The probe features a dedicated ultrasound imaging transducer, allowing real-time imaging at any point during the procedure. The HIFU transducer around it incorporates proprietary dynamic focusing technology for pinpoint precision of ultrasound energy. All movements are robotically controlled with five degrees of freedom, and the system auto-adjusts in real time for the position of the rectum. The HIFU procedure is performed in an outpatient setting. The patient is placed on a standard OR table in a lateral decubitus position under general or spinal anesthesia. First, the probe is manually inserted into the rectum by the physician.

The system will then automatically acquire a 3D ultrasound volume of the prostate. This high-resolution image allows visualization of critical structures. The operator can seamlessly import diagnostic images, such as MRI and 3D biopsies, from various platforms. These volumes are then registered with the real-time ultrasound using a proprietary elastic fusion algorithm called HIFUSION. The yellow target area defined on the MRI is automatically overlaid at the right position on the real-time ultrasound image and will be used as a visual guide to plan the treatment. The urologist then precisely defines the upper and lower limits of the treatment zone. The computerized system creates virtual slices every 1.7 millimeters to cover the whole ablation area. For each individual slice, the operator shapes the contour of the target to provide a safety margin around the lesion while avoiding critical structures.

The Focal One robotic system will execute the plan, controlling and readjusting automatically before each individual pulse of HIFU energy. During the process, the urologist maintains control and monitors the ablation through real-time visualization. They can pause and readjust the plan at any time. As shown here, the area ablated can be clearly visible on imaging, highlighting that the critical structures of the prostate are spared, minimizing the risk of side effects such as incontinence and erectile dysfunction. Once the procedure is complete, the patient is sent home the same day with a catheter and can rapidly resume normal activities. Focal One: Leading Prostate Care with Robotic Focal HIFU.

The Focal One platform has a number of proprietary technologies, certainly in HIFU or high-intensity focused ultrasound robotics. We have a five-axis robotic positioning system, AI capability through third-party offerings, and more AI to come, advanced imaging, including with Focal One Eye, the ability to bring in PSMA PET, and then remote connectivity. We can connect to other centers that have a Focal One device. In fact, we did the first world's teletreatment from Cleveland Clinic, Ohio, to Cleveland Clinic, Abu Dhabi. When we look at the market opportunity in urology, and specifically in prostate cancer, it is very large. If you look at the numbers here, nearly 1.5 million patients annually, the Lancet Commission on Prostate Cancer published last year, April of 2024, that this number will double to 2.9 million by the year 2040. It is a large, addressable market, but also a growing addressable market.

If you look at prostate cancer, it's not one cancer, it's millions of cancers. It's a heterogeneous cancer. The goal here is to risk stratify those patients and provide the most efficacious treatment. Low-risk disease would be commonly prescribed active surveillance or no treatment. On the far right side of the equation, you can see high-risk disease would be maybe surgery or radiation. There is a major gap in the middle here when we look at favorable intermediate-risk disease. That's the problem Focal One can solve. Additionally, we know that primary radiation therapy has a failure rate cited in the literature anywhere from 15% to as high as 30%. We are an excellent technology for salvage treatment. In fact, we're written into the NCCN guidelines in the United States. If you think of what's happening in the market, this describes it very well.

If you look off to the left, the traditional market was radiation, surgery, or active surveillance, no treatment, a protocol. This emerging market with focal therapy is growing now as we speak. The market at maturity will be quite significant and can be and will potentially be larger than the standalone categories of surgery and/or radiation. We know this because if you look at the data here, this is CMS government data published from calendar years 2022 through 2024. HIFU is actually growing. HIFU is growing where other types of treatments, surgery, brachytherapy, radiation, cryo, freezing the prostate, are either flat to declining. We have strong supporting clinical evidence driving this paradigm shift. If you think about it, when we talk about prostate cancer, it's really about the trifecta outcomes. What does that mean? It means, number one, we've got to control the cancer or eradicate the cancer.

That's the primary goal. We also need to address what the patient is left with in terms of functional outcomes, meaning preservation of sexual function, preservation of urinary control. These are really important domains. We call it the trifecta because it's really the balance of these three that matter the most when treating prostate cancer. This is a great slide to basically understand where we are today. If you think about it, on the left side, you have active surveillance, which is a protocol monitoring the patient and involving really no treatment. On the far right, we jump over to radical treatments such as radiation and surgery. There's a big void here between these two areas. We cross that void with Focal One robotic HIFU.

If you look at the data here, cancer control outcomes, which I'll talk about more in a few publications, we have data that supports it now. We know that if we don't cut the organ out or we don't radiate it, the patient likely will do better in preservation of sexual function and urinary control. The last one is the patient burden. The patient experience really shows that a non-invasive treatment like Focal One, which involves no cutting, no blood loss, no radiation, has some patient benefits, as noted. One of the most important studies was published last year called the HIFY study. This is the largest study ever published of its kind. It was not paid for by the company. The bill on the study was EUR 22 million, and it was performed in France across 46 centers.

The primary endpoint was oncologic control, going back to the trifecta. The second endpoints were preservation of sexual function and urinary control. As we treated, or patients were treated, 3,328, we met both primary and secondary endpoints. These are with EDAP technology, our technology exclusively. Additionally, FARP, which stands for focal ablation versus radical prostatectomy, this study will be published within ideally the next six months. This is a randomized control trial where surgery and HIFU were randomized to these patients, 213 patients in the trial. As noted, it was presented this year at the AUA meeting in May, and it showed again what we saw in the HIFY study, that we provide adequate oncologic control. We meet that domain, but we perform certainly above or better on the functional equation.

Lastly, a study came out in Taiwan recently that talked about radiation, external beam radiation versus HIFU. Based on 10-year oncological outcomes, HIFU versus external beam radiation therapy, we showed meeting the endpoints of oncologic control. In fact, some of the domain was actually more favorable to HIFU. Overall, there was lower mortality at 10 years for HIFU as compared to external beam radiation therapy. Secondly, the lower cancer-specific mortality rate after HIFU as compared to external beam radiation. We are selling our systems throughout the U.S. and in global markets. As you can see here, we're in a number of key centers. We have nearly 80 systems placed, and that install base is growing. We're in some of the top cancer hospitals and academic hospitals ranked in the world. In fact, Cleveland Clinic, Mayo Clinic, Memorial Sloan Kettering, MD Anderson.

We're in every University of California teaching hospital in California. That's five. We're in USC. We're in a number of community hospital systems, and several of them have bought second Focal Ones. We're seeing both the growth in academic and community hospitals. That includes Kaiser, that is now running Focal One in Southern California and Northern California. Lastly, we drive procedure momentum, which is part of our model. We're a capital equipment play. We sell capital equipment. We generate revenue on service, but we also generate disposable revenue. As noted here, the CAGR, 67% Focal One on our procedures over this time period, and the CAGR on system growth is noted here as well. Last quarter, we showed that the procedures on a quarter-over-quarter basis from 2024 to 2025 grew 15% Q3, and quarter-over-quarter Q2 to Q3 grew 11%. Okay, I'll stop there.

Oh, one last slide, sorry. We are also not just a prostate cancer company. We're also focused in a couple of emerging new indications, one being BPH. We know that when you ablate the prostate tissue, you relax the pressure on the prostatic urethra. We've now started a beginning of a study, one in Europe and then one in New York. The IRB was just approved at Mount Sinai Hospital in New York. We're going to start recruiting those patients and treating here by the end of the year. Additionally, we received, using the same technology, Focal One, the ability to treat stage four or deep infiltrating endometriosis. That is now CE mark, and we're in a limited launch in Europe. Thank you.

Great. Maybe we'll start on Focal One. We've seen a couple of good quarters of great placements. At the same time, in parallel, we've seen good readouts from both FARP and HIFY. You've spoken previously about technology crossing the chasm. I was curious, at what point are we now in this adoption curve? What do you think gets us to the next step?

That's a great question. I really think we're, if you go to Jeffrey Moore's crossing the chasm, I think we're really in that one-third early portion of early adoption. We moved through the innovators category. Now, many of you know I worked at Intuitive Surgical, and we worked in robotics, and we went up that adoption curve. I feel like a lot of good things are happening now. New data is coming out. We've got reimbursement in place. We have a category one CPT code. The proposed rule in the U.S. shows a 5.6% increase. Final rule will be published here, ideally before the end of the year. We have reimbursement, we have data, we have a new platform, Focal One Eye, and we've expanded our sales force, both the capital team and clinical teams, and also made investments in our European commercial teams.

I feel like a lot of the pieces are in place. Again, we had record HIFU revenue last quarter. We see our pipeline growing, specifically our active pipeline. I think we have a strong potential to continue to work through this early adoption, early adopter phase, and we'll see more placements happening or more sales happening in community hospitals, not only in the U.S., but outside the U.S. as well.

Great. Maybe now let's try and narrow in on Focal One HIFU procedure growth, which I think in Q3 was up, which reaccelerated to 15%. I think, firstly, can you tell us about what drove that reacceleration? And then looking forward, how do we get back to more of that 30% growth in the future? Thanks.

Yeah. We announced earlier in the year we had some incidents with some of the payers, specifically Medicare Advantage plans. We've navigated through that. Many of these go through an appeal process to administrative law judge, and they commonly are submitted by a patient, and the rulings are typically in favor of patients. I feel like that has been good progress in the short term as compared to the beginning of the year. Additionally, we sell a program. We launch it as a program, we build it as a program. How it's launched and the behaviors in the first 90 days is really, really important because we sell a clinically necessary strategic revenue-enhancing service line with strong economic reward in the number one cancer diagnosed in men.

That's strategic for a hospital to make the investment and important for hospitals also to adopt the technology and physicians to perform the procedure. I think as more data comes out, I think the FARP clinical trial data will be very, very helpful. HIFY has been very helpful. In fact, there is a website dedicated to it, hifystudy.com. Now we're seeing more activity working through the payers, et cetera. I think what we see is that focal therapy is here to stay. It is the biggest shift in how we treat this disease. If you're going to build a focal therapy program, you want to have Focal One as your first investment to grow and launch this program. That's what we're seeing now. I think if we continue on that path, we'll see the adoption and procedure growth accordingly.

Great. Now, maybe transitioning to BPH. You commenced a limited launch in some European markets. In the U.S., you had your first IRB approval to kick off U.S. trials with Mount Sinai. I wanted to kind of start by talking about how you view the BPH opportunity for EDAP and for Focal One. Then maybe is it BPH broadly or BPH with comorbid prostate cancer?

Yeah, very good question. We see BPH was a natural progression. As we were treating prostate cancer patients, commonly they were reporting back through their urologist that their urinary symptom scores were improving. Obviously, if we're ablating tissue within the prostate gland, we're relaxing pressure on the prostatic urethra. We're still early in this, but what's exciting about it, it's a large TAM, large addressable market. There are other competing technologies out there. I think here, again, we come at it from a non-surgical approach. Focal One is an outpatient procedure, and the delivery in the outpatient suite in terms of treatment time is somewhere in the range, 40-60 minutes, not including patient positioning and such. It has optimal workflow and optimal choreography as an outpatient procedure.

As we work on the activities in Europe, we're kicking off this IRB study with Mount Sinai, and we'll be able to hopefully open it up to other centers over time. We'll start with Mount Sinai, and then we'll progress from there. I think the opportunity is real, and it fits very well with the existing call point of prostate cancer.

Great. Now that you're setting the foundation for BPH for EDAP, is there any sort of color you can give on any milestones that investors can look forward to?

Yeah, I think as I stated on our last earnings call, we hope to treat our first patients as part of this IRB protocol at Mount Sinai. That would be one of our internal milestones is to treat our first patient or patients before the end of the year. I think that that's really important. Shifting over to endometriosis, because I think that's another part of the equation, we have a women's health defined focus in treating stage four endometriosis. Why that's important is women at stage four do not have a lot of good options. It is typically a surgery, a rectal resection, partial rectal resection, a serosal stripping procedure. It's a pretty morbid treatment to achieve uterine preservation. We are excited about this limited launch in Europe.

We will be able to provide additional updates in the coming months on how we are progressing with that. Also, just to remind everyone on endometriosis, we had a clinical trial performed in the sham study, which was comparative to treatment and no treatment. When women were unblinded in the sham arm, they were given the opportunity to be treated. Over 84% of the women opted to be treated. We are following that subset of patients as well on the endometriosis front. We are excited as we look outward in our strategy and seeing the clinical findings that we will likely see over time.

Great. Maybe with the few minutes we have left, I want to ask one more on BPH and one on the financials. Firstly, on BPH, I know it's a pretty competitive space. I was hoping you can double-click some more on how investors can stratify the competitors and where Focal One fits in.

Yeah, I mean, it's a bit early. I mean, I think here we have an opportunity in a segment of that market. We've done some kind of internal analysis. Again, I can't give you hard numbers. I think the goal here is that we can offer Focal One as a treatment and be able to deliver a treatment that requires no use of surgery, no implantable foreign body material. I mean, we're coming at it from the HIFU approach, transrectal, same machine, and again, under ultrasound guidance, which is commonly used by urologists. Again, I can't give you hard numbers, but I think outward we're very optimistic that this can be a very good strategy for the company and lock additional value for our shareholders.

Wonderful. Thank you. Lastly, I wanted to ask on some of the financials and looking at your midterm margin trajectory, both on gross and operating margins. How do we look at that progressing over the next year or so, year or three years?

I'll turn to Ken to answer that question.

Ken Mobeck, CFO, EDAP: Yeah, so good question. Earlier in the year, in our Q1 earnings call, we talked about transitioning the company and really focusing, separating our businesses into HIFU and non-core, okay, and non-core being our distribution and ESWL businesses. As you can see with our Q3 financial results for this quarter, our margins are up from 39.4% to 43%. I think this is a clear indication by focusing on the higher margin business units, i.e., HIFU, we're heading in the right direction. As we move forward as a company, since we are disinvesting in some of our non-core businesses, that's allowing us to take some of those operating expenses and then invest them in the HIFU business without incrementally adding more dollars of investment to HIFU. We really see that as a good strategy as we move forward to grow operating profit, i.e., via higher gross margin.

That'll help us as our goal is to get profitable here as we move forward in the coming years.

Wonderful. Thank you very much. If there's anything you'd like to mention that we didn't cover on, more than welcome to.

Ryan Rhodes, CEO, EDAP: No, thank you for having us here as your guest. Again, I referenced the hifystudy.com. That is a website, of course, also focalone.com. So thank you.

Wonderful. Thank you for your time.

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