EDAP TMS S.A.

Good day, everyone, and welcome to today's EDAP TMS third quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and one on your telephone keypad. Please note this call is being recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn today's program over to John Frantz. Francis of LifeSite Advisors.

Good morning. Thank you for joining us for the EDAPTMS third quarter 2024 financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, Ken Mobik, 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, which include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such forward-looking statements. Factors that may cause such a difference include but are not limited to those described in the company's filings with the Securities and Exchange Commission. I would now like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes. Ryan?

Thank you, John, and good morning, everyone. In the third quarter, we reported total worldwide revenue in U.S. dollars of $14.4 million, representing currency-adjusted growth of 11.6% on a year-over-year basis. Our core Focal One Haifu business continues to experience strong growth with a 48.2% year-over-year increase in revenues, reflecting continued adoption of Focal One throughout the global urology community. We placed three focal one systems in the third quarter, which included a system placement with Virginia Commonwealth University, as well as placements in Italy and Spain. All three placements were cash sales, and the focal one sale to Virginia Commonwealth University was our first placement in the state of Virginia. Virginia Commonwealth University is also one of only two National Cancer Institute designated comprehensive cancer centers in Virginia. As noted on our second quarter earnings call, a growing number of leading U.S. cancer treatment centers are now using Focal One based on our technology's proprietary robotic platform that targets cancerous cells in the prostate while sparing the surrounding healthy tissue. As a reminder, last year in the third quarter, we saw several engaged customers delay their purchase of Focal One to the fourth quarter. We are experiencing a similar pattern of purchasing behavior this year, and as such, We expect to finish 2024 with a strong fourth quarter performance. As positively noted, we have already closed a focal one sale in the US early in the fourth quarter with St. David's Hospital in Austin, Texas. St. David's is part of HCA Healthcare, the nation's leading provider of healthcare services, comprising of 186 hospitals and approximately 2,400 care sites in 20 states and in the United Kingdom. The cash sale at St. David's Hospital came at the conclusion of a successful evaluation period that demonstrated positive clinical outcomes, high procedure volumes, and favorable reimbursement while also meeting the hospital's strategic business objectives. This first sale in an HCA hospital has the potential to facilitate and accelerate the closing of future sales as we are currently in discussions with multiple hospitals within the HCA group. We also continue to experience strong growth in U.S. Focal-1 HIFU procedures. During the quarter, U.S. procedures grew 34% on a year-over-year basis, which reflects continued adoption by urologists who see Focal-1 as an important treatment option for delivering targeted focal therapy in earlier stage prostate cancer patients. As mentioned during our last call, We believe that as the results from the groundbreaking HIFI study become more widely disseminated, demand for the FOCAL1 platform will continue to grow. The HIFI study presents clear and compelling evidence that robotic HIFU therapy delivered by EDAP's proprietary technology is as effective as radical prostatectomy as a frontline treatment for the management of localized prostate cancer, while additionally offering patients better functional outcomes with respect to preservation of urinary continence and sexual function. As a reminder, EDAP technology was used exclusively to treat all patients receiving HIFU therapy in this study, including 90% with the FOCAL-1 platform. We anticipate the publication of the HIFI study results in a high-impact peer-reviewed medical journal which will provide focal one HIFU with important visibility to aid in accelerating market adoption. I will now provide a brief update on focal one reimbursement. The Center for Medicare and Medicaid Services, CMS, just released the final payment rules for 2025 on November 2nd. The HIFU procedure continues to be supported with favorable reimbursement with CMS finalizing a Medicare hospital payment rate of $9,247 as a national average per the adjusted corresponding local wage index factor. This rate will become effective on January 1, 2025, and represents a 5.4% increase over the 2024 payment. These reimbursement levels continue to support the favorable strategic business case for hospitals to both invest and integrate focal one HIFU while providing greater patient access to this valuable non-invasive treatment option. CMS also released the Physician Fee Schedule for 2025, which continues to provide strong physician reimbursement for HIFU with 17.73 work relative value units, or work RVUs, and 29.41 total RVUs. These figures are significantly higher than any other prostate ablation procedure. Additionally, it provides physicians with a level of reimbursement that is more than 80% of the payment for performing surgery, including robotic radical prostatectomy. In conclusion, we are pleased with the continued support of the defined reimbursement levels for the use of HIFU, which provides a financially sound and sustainable economic offering for both the hospital and the physician. I would now like to briefly discuss some of our recent strategic collaborative activities. On September 19th, we announced a very exciting collaboration with Avenda Health for the purpose of launching the world's first AI-assisted Focal-1 robotic HIFU procedures. Avenda's FDA-cleared Unfold AI technology builds 3D patient-specific cancer maps that reveal the extent of the tumor boundaries while enabling physicians to deliver more precise and tailored treatments. By leveraging Unfold AI's planning with the FOCAL1 robotic HIFU platform, we believe that urologists can provide a more customized, patient-specific HIFU ablation procedure for treating prostate cancer. The first series of these FOCAL1 AI-assisted procedures have already been conducted by Dr. Wayne Brisbing, Assistant Professor of Urology at the University of California, Los Angeles David Geffen School of Medicine. Thus far, we have received overwhelmingly positive feedback with respect to the combination of these two groundbreaking technologies. AI represents an important and strategic next step in the evolution of the FocalOne platform and will help us remain at the forefront of delivering the most advanced focal therapy treatment solutions for patients diagnosed with prostate cancer. During the quarter, we had a notable presence at several strategically important urology-focused scientific meetings. We conducted numerous FOCAL1 simulated procedures at the 2024 joint meeting of the Focal Therapy Society and Society of Urologic Robotic Surgeons, which took place from September 19th through the 21st in Washington, D.C. During this scientific meeting, there was significant interest surrounding our FOCAL1 technology, And this meeting serves as an important venue for building our relationships with the leading neurologists in the United States. We also had a major presence at the 2024 Focal Plus annual meeting, which took place from October 17th through the 19th in San Diego, California. The Focal Plus meeting is particularly relevant to our business as the majority of attendees have a growing interest in utilizing focal therapy for prostate cancer. There were numerous presentations highlighting focal one HIFU at the meeting, and we continue to see strong interest amongst urologists who recognize the need to offer a suitable treatment option between active surveillance and radical therapy. Early in the third quarter, we attended the 41st World Congress of Endourology and Eurotechnology meeting, which took place in Seoul, South Korea, from August 12th through the 16th. During this meeting, we provided dozens of hands-on focal one simulations, which garnered strong engagement from the intending urologist. To quote Dr. Indaber Gill, addressing a large audience of urologists at the meeting, going forward, if you don't offer focal therapy, your prostate cancer practice will start shrinking. Dr. Gill is a pioneer in robotic surgery and world-renowned expert on urological disease and chairman of urology at the University of Southern California Keck School of Medicine. The WCET scientific meeting also featured a semi-live moderated FOCAL-1 clinical procedure conducted by Dr. Tarek Benadir, clinical assistant professor at the University of Florida, which demonstrated numerous benefits of the FOCAL-1 robotic platform. I will now briefly touch on our clinical development programs in BPH and endometriosis. On October 1st, we announced that the first patients were treated in our combined Phase 1-2 study, evaluating Focal-1 robotic HIFU for the treatment of benign prostatic hyperplasia, or BPH. As a reminder, BPH represents an enormous market opportunity for Focal-1. Globally, 94 million prevalent cases of BPH were estimated in 2019, and in the U.S. alone, as many as 15 million men currently have BPH symptoms. The Phase 1-2 study is a company-sponsored prospective multicenter clinical trial and is designed in two parts. The first part of the study is taking place at three leading institutions in France with a recognized expertise in the treatment of BPH, as well as in the use of FOCA-1 HIFU technology. Part one is designed to define the treatment parameters per protocol to effectively treat BPH with the goal of achieving optimal patient outcomes. Part two of the study will expand patient enrollment across a larger number of clinical sites in order to validate the safety and efficacy of the parameters as defined in part one of the study. We are particularly excited about this program as the FOCAL-1 approach, when compared to other treatment options, has the potential to better protect the integrity of the urethra and other critical structures. We believe that FOCAL-1 could become an important, effective, and less invasive treatment approach for addressing BPH. The ongoing Phase I-II study will also serve as a foundation for initiating a clinical trial in the United States next year. I'll now provide a brief update on our endometriosis program. As previously announced in July, interim results from our phase three study evaluating robotic HIFU technology for the treatment of deep infiltrating endometriosis showed that robotic HIFU therapy maintained an excellent safety profile while demonstrating greater reductions in endometriosis lesion volumes as compared to patients in the sham arm of the study. Both arms of the study also showed significant improvements in pelvic pain reduction at three months from baseline as measured by the standardized visual analog scale. As previously reported, the primary endpoint of superior reduction in acute pelvic pain in the HIFU arm compared to the sham arm was not reached. However, upon further review by the clinical investigators, This outcome was likely attributed to comparing differences in pain scores between the two arms of the study after only three months following the procedure. In our view, a therapeutic benefit favoring robotic HIFU is more likely to be confirmed over a longer period of time post-procedure, as suggested by the stabilization of pain scores at 6 and 12 months from our published peer-reviewed Phase II studies. At present, the study is now unblinded and patients have been allowed to cross over to the HIFU arm protocol. I'm pleased to report now that 85% of the patients from the sham arm have already elected to cross over into open-label extension arm of the study and thus receive treatment with robotic HIFU. This is not surprising as the pain symptoms for these sham patients return back to their high baseline levels after one year post-procedure. In contrast, the patients from the HIFU arm who were evaluated one year following robotic HIFU treatment maintained a similar level of improvement over their baseline pain symptoms as measured at three months post-procedure. Importantly, these findings are consistent with a significant reduction in lesion volume as measured by MRI, which was observed in the HIFU arm only following the unblinding of the study. This additional data continues to suggest that HIFU therapy is a safe, non-invasive treatment that has significant potential to reduce pain for women suffering from this debilitating condition. Between now and year-end, we anticipate meeting with the FDA to discuss this additional data while determining the next steps for this program. Before handing the call over to Ken to review our third quarter financial results, I want to briefly mention a change to our board of directors. Following the departure of Mark Ozakowski, we appointed our existing board member, Dr. Lance Wilsey, to serve as interim board chair, effective September 30th. Dr. Wilsey is playing an active role assisting the executive team while we continue to search for a permanent replacement. Dr. Wilsey was first appointed to the EDAP Board of Directors in December of 2023 and has since made valuable contributions to help guide our strategic planning as we expand the Focal One platform across the global urology market. Dr. Wilsey is a trained urologist who has over 35 years of private and public board experience focused in the area of cancer diagnostics and therapeutics. He completed his surgical and neurology training at the Massachusetts General Hospital and additional postgraduate training in the Steele Lab at Harvard University and the Dana-Farber Cancer Institute. I will now turn the call over to Ken to review our third quarter financial results.

Thanks, Ryan, and good morning, everyone. Please note that all figures except for percentages are in euros. For conversion purposes, our average euro-dollar exchange rate was 1.101 for the third quarter of 2024. Total worldwide revenue for the third quarter of 2024 was 13.1 million euros, an increase of 11.6% as compared to total worldwide revenue of 11.7 million euros for the comparable period of 2023. This was a record for third quarter revenue performance. Looking at revenue by division, total revenue in the HIFU business for the third quarter of 2024 was 4.5 million euros, as compared to 3 million euros for the third quarter of 2023, which represents a growth of 48.2% year over year. We placed three Focal One systems in the third quarter, and all three placements were cash sales. Third quarter worldwide HIFU disposable revenue grew 35.3% on a year-over-year basis, reflecting strong U.S. procedure growth. Total revenue in the distribution business for the third quarter of 2024 was 6.6 million euros, as compared to 6 million euros for the third quarter of 2023. Distribution revenue was driven primarily by recurring revenues from laser sales. Total revenue in the litho business for the third quarter of 2024 was €2 million, as compared to €2.7 million for the same period in 2023. The decrease in litho revenue was due to selling three lithotripsy units in the third quarter, as compared to seven units sold in the third quarter of 2023. Gross profit for the third quarter of 2024 was €5.2 million, euros compared to 4.2 million euros for the year-ago period. Gross profit margin on net sales was 39.4% in the third quarter compared to 35.5% in the year-ago period. The increase in gross profit margin year-over-year was due to a favorable shift in focal one product mix and positive absorption in the factory. Operating expenses were 11 million euros for the third quarter compared to 9.7 million euros for the same period in 2023. Operating expenses increased primarily due to investments made to support focal one commercial operations globally. Operating loss for the third quarter of 2024 was 5.8 million euros, which was relatively flat compared to an operating loss of 5.6 million euros in the third quarter of 2023. Net loss for the third quarter of 2024 was 6.4 million euros, or 0.17 euros per diluted share as compared to net loss of 3.9 million euros or 0.11 euros per diluted share in the year-ago period. Turning to the balance sheet, ending inventory was 21 million euros in the third quarter of 2024 as compared to 15.1 million euros at the end of the fourth quarter in 2023. As I mentioned last quarter, we have made advanced purchasing decisions related to ultrasound technology, and we have built additional focal one and exact view inventory in anticipation of higher demand. Also, as a result of new medical device requirements under CE mark, multiple ESWL units had to be manufactured in advance of these new requirements becoming effective. We anticipate selling the ESWL WL inventory down by the first half of calendar year 2025. Total cash and cash equivalents at the end of the third quarter was 25.5 million euros as compared to 43.5 million euros at the end of the fourth quarter of 2023. The 18 million euro decrease in cash and cash equivalents on the year-to-date basis was attributed to spending on operating activities, including of inventory investments, as I described earlier, capital investments to help grow the HIFU business, and pay down of long-term borrowings. We remain focused on optimizing our investments from both an operating and cash resource perspective so that we can effectively manage and grow our focal one business in the long term. Those are our key financial highlights for the third quarter of 2024. And with that, I would like to turn the call back to Ryan.

Thanks, Ken. As we look outward, we are making significant investments to capitalize on the growing focal therapy market opportunity with the most advanced technology platform and a growing install base of focal one systems at leading institutions and hospitals. We are achieving this strategic objective as we build an important new treatment category for prostate cancer that lies between active surveillance and radical therapy. While building a new treatment category takes time and effort, there is no question that this paradigm shift in the treatment of prostate cancer is taking place. And we believe Focal One is fast becoming the leading technology platform that will dominate this new treatment category for years to come. As we grow, we continue to deploy our talent and capital in a highly strategic manner for the purpose of building relationships across a continuum of stakeholders, including all the urology major practices, large hospital networks, and urology fellowship programs. Through these efforts, we are creating world-class robotic HIFU treatment programs to ensure that focal one is being fully utilized and that more urologists are being trained early in their careers to use this important technology. As discussed in my prior comments, we are also attending the most relevant urology-focused scientific conferences around the world and integrating cutting-edge new technologies such as AI to further extend our market and technology-leading position. These combined efforts are translating into commercial success as demonstrated not only by our consistently strong year-over-year procedure growth in the U.S., but also by the strong FOCAL1 adoption amongst the most well-recognized cancer treatment centers. In fact, FOCAL1 is now installed in over one-third of the National Cancer Institute designated comprehensive cancer centers, and we expect that percentage will continue to grow. As more urologists embrace FOCAL1, higher utilization will lead to more clinical data and this data will gain more attention at upcoming urology meetings. This data will also lead to more peer-reviewed publications, which further validates the technology and will provide a basis for expanding robotic HIFU and the treatment guidelines for prostate cancer. As urologist enthusiasm and adoption continues to grow for FOCAL1, we also see growing demand coming directly from patients who will increasingly seek effective, less invasive treatment options that fall between active surveillance and radical therapy. Patients and their doctors want to address cancer earlier in the course of the disease while also maximizing quality of life outcomes. As a non-invasive therapy providing excellent oncologic control, FOCAL-1 therefore represents an important treatment option for many of these patients. As we have discussed on past earnings calls, I believe we are in the early stages of an important and positive shift in how prostate cancer is being managed. As noted, we are executing on our strategic goal of establishing Focal One as the premier robotic HIFU therapy for prostate cancer, which we believe will generate significant value for our shareholders. With that, I would now like to turn the call back over to the operator for questions. Operator?

At this time, if you would like to ask a question, please press the star and 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star and 1 if you would like to ask a question. And we'll take our first question from Michael Tarkone with Jeffries. Please go ahead. Your line is open.

Good morning, and thanks for taking the question. I guess just to start, hi. Can you elaborate a little more on what you're seeing just in the, among the hospital customers and the F1 pipeline, you know, three placements this quarter? I think last quarter you said, you know, you were expecting second half placements to exceed first half. Is that still the case? So yeah, basically the pipeline, what you're seeing in the hospital environment and then 2H versus 1H placements. Thank you.

Yeah, Michael.

We saw good activity in the third quarter. Of course, we're always building our pipelines. We had a few sales that slipped into Q4, as noted. We are still planning on having a stronger back half of the year, second half of the year. We continue to see momentum and high-level engagement in many of our pipeline customers. And again, coming off of a number of very key scientific meetings and some of the engagement we have, There's been very strong clinical interest from many urologists in attendance to those events. So, yes, we do continue to see a strong growth in the second half of the year.

Got it. Thank you. And, you know, you're still seeing nice focal one procedure growth in the U.S. year over year. Ryan, I was wondering if you could just maybe elaborate some on how utilization per customer is

Or account has been trending and you know, maybe where that stands today Yeah, so as we're adding really a new treatment service line when we launch our focal one programs There's a ramp period so we look at our accounts, you know objectively as programs So we build these programs we launch them and then there's typically a ramp period there's a training period and onboarding period and We continue to see hospitals, you know, increasing their procedures, some faster than others. But, you know, the commitment is there. And as noted, you know, we made an announcement on terms of reimbursement. Reimbursement continues to be strong. So there's, you know, there's the economics that support the activity. But I think the real thing we see is increased clinical value demonstrated back from a number of our installed users. The data that's been presented at some of the local scientific meetings and national meetings has been very positive. We continue to see some hospitals now turning on more marketing activity to attract a broader patient population. So, again, good, healthy growth on procedures is something we pay a lot of attention to. We have a bifurcated sales force, meaning one that focuses on capital and one that focuses on clinical. And we continue to monitor adoption at each account and utilization by each urologist trained on use of focal one.

Great. Thank you, Ryan. Thank you.

Thank you.

And once again, that is start and one if you would like to ask a question. We'll take our next question from Sean Lee with HC Wainwright. Your line is open.

Hey, good morning, guys. This is Sean here for RK, and thanks for taking my questions. I just have two quick ones on the clinical programs. So, regarding the DGH study, when can we expect the initial results from that and what kind of data would that entail?

Well, as noted, we're on the journey of a phase one, phase two study. So, results we would not see until sometime later next year. Again, we are combining these two parts of the study really to accelerate our scientific findings around treatment parameters, et cetera. So, we've got a well laid out plan. As noted, we have three sites now that are active and we have the ability to add additional sites. Once we get through some of the early work we're doing now, we will expand to other sites. So, it won't be until later next year. and we'll be excited to obviously present some of that data and those findings accordingly.

Great. One quick follow-up on that. How many patients are expected in the first two parts?

Yeah, well, it really is truncated on the protocol, so it's broken down in various numbers. You know, we have a subset of 30 to expand above 30 to 60. It's called out directly in the protocol. I think the thing to understand in the study is that we've combined both parts of the study, right, the phase one and phase two parts. And as we look at that, our goal is to accelerate to more sites. Once we look at treatment parameters, including, you know, volume, treatment location, and really setting up the procedure for a wider group of participants, we'll be able to play with those numbers in terms of what we would like to see as we move forward and write additional new study protocols. So that's where we're at with that. We're excited about this program, and we have other centers that are very eager to participate.

Great. Thank you for that. In the prepared remarks, you mentioned that the company expects to initiate a BPH study in the U.S. next year as well. Would that mirror this French study, or would you modify it based on what you see in this first study?

Okay. Can you repeat that? We can't hear you here.

In the prepared remarks you mentioned, I think you mentioned that the company expects to start a U.S. clinical study in BPH as well next year. Would that mirror the first French study, or are you going to modify it based on what you see first?

Yeah, yeah. So I think what we want to do here is take the results of the combined Phase I-II study to expand to multiple sites. While we're doing that, we'll be looking at protocol design to get in front of the FDA sometime next year. So again, we're accelerating this process and look to expand it to additional sites. And again, we would be working closely with our investigators to develop the right protocol that would suit the needs for the FDA.

Thank you for that clarification. And my final question on the endometriosis program. So you mentioned that the longer-term effects are more likely to see a benefit for HIFO. So how long are you continuing to follow these patients for longer? And when do you expect to release these longer-term results sometime down the line?

So we've shown, again, that we, per protocol, have the ability to continue to follow these patients, and we have the ability to follow outwards of 12 months and beyond. So, again, we're continuing to monitor these patients closely. I think what we've shown clearly and commented on previously is that we've shown high safety in use of the technology. We've showed a reduction in the size of the MRI, under MRI visualization, the reduction of lesion size in the HIFU arm. And then we've shown a crossover rate of 85%, meaning that patients who were followed in the original study upon being unblinded were returning back to their baseline pain scores. So that represents something we've socialized before and made comment to, that the follow-up time at three months was probably not adequate to prove the data endpoints that we needed post-treatment. So again, I think what our goal will be is we've got expected meetings with the FDA here before the end of the year, and we will be using the latest data analysis and follow-up to prepare for that conversation with the FDA. We're excited about some of the findings we've had recently as we've uncovered more of this, but clearly we have high belief in the procedure and we will continue to look positively outward.

Great. Thanks again for taking my questions. Thank you.

Thank you. We, once again, that is star and one if you would like to ask a question. And it appears we have no further questions on the phone.

I will turn the program back over to Ryan Rhodes for additional or concluding remarks.

I want to thank everyone again for joining us on our today's call, and we look forward to seeing you at the upcoming Jeffries London Healthcare Conference on November 19th. and the following month at the Piper Sandler Healthcare Conference in New York City. Thank you.

This does conclude today's conference. Thank you for your participation. You may disconnect at any time.