EDAP TMS - Earnings Call - Q1 2025

Transcript

Operator (participant)

Hey, I'd like to welcome everyone to EDAP TMS First Quarter 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press star, then the number one on your telephone keypad. If you would like to withdraw your question, please press star, then the number two on your telephone keypad. Today's call is being recorded. I would now like to turn the call over to John Fraunces. Please go ahead.

John Fraunces (Head of Investor Relations)

Good morning. Thank you for joining us for the EDAP TMS First Quarter 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, 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 Rhodes (CEO)

Thank you, John, and good morning, everyone. Over the last several months, EDAP has made a series of important strategic decisions to further transform our company in becoming the global leader in HIFU focal therapy. In support of this strategy, we announced a series of important achievements, which demonstrate the beginning of this transformation across multiple areas of our business.

We placed nine Focal One systems in the first quarter of 2025, which is a record number of placements for any prior first quarter period. In March, we announced that Focal One received CE mark approval for the treatment of posterior deep infiltrating endometriosis. In April, we launched the new Focal One i Robotic HIFU system at this year's 2025 AUA meeting.

As our Focal One business continues to achieve these important milestones, we are also seeing a growing body of clinical data in support of Robotic focal therapy for the management of prostate cancer. Most notably, positive results from the FARP randomized controlled trial were presented at this year's 2025 AUA meeting, which we will discuss in more detail later on this call.

Finally, we announced that urologists from the Cleveland Clinic, Ohio, and the Cleveland Clinic, Abu Dhabi conducted the world's first remote transatlantic Focal One Robotic HIFU procedure. A presentation discussing this groundbreaking procedure was to be delivered at this year's AUA meeting, and later on the call, I will provide additional details about this groundbreaking event.

Collectively, these significant commercial, regulatory, and clinical milestones reflect our continued strategic focus on growing our core HIFU business and further validate the growing demand for Focal One from the global urology community. I will now discuss our system placement activity for the first quarter. As noted, Focal One continued along its positive growth trajectory in the first quarter of 2025.

We placed nine Focal One Robotic systems in the quarter, which is a record number of system placements for any first quarter period in our company's history. The nine placements included six cash sales and three operating leases. In the U.S., our two cash sales were placed in Dallas, Texas, one with Baylor Scott and White Health and the second with Methodist Charlton Medical Center.

Baylor Scott and White Health is the largest nonprofit healthcare system in the state of Texas and ranks amongst the largest healthcare systems in the United States with nationally recognized medical services, including urology. Methodist Charlton Medical Center is part of the Methodist Health System, which has a network of 13 hospitals and more than 75 primary care and specialty clinics located throughout the region. We believe the investment being made by such prominent community healthcare systems further reflects the growing recognition that Focal One is fast becoming a medically necessary treatment option for prostate cancer patients.

Importantly, both of these large healthcare systems operate in a very competitive environment within the fourth largest metropolitan statistical area in the United States, which represents another significant opportunity for Focal One to reach a large and important patient population. We also signed individual Focal One operating leases with three major hospital providers.

These included Vanderbilt University, the University of Colorado, and Kaiser Sacramento in Northern California. Both Vanderbilt University and the University of Colorado are members of the National Comprehensive Cancer Network, or NCCN, which is an alliance of 33 of the leading U.S. hospital cancer centers devoted to patient care, research, and education. I am pleased to note that over half of these NCCN member institutions now have access to our Focal One Robotic HIFU platform.

In addition, the University of Colorado also has an active Society of Urologic Oncology SUO fellowship program. By establishing a Focal One training program within these highly regarded, prestigious institutions, we can train the next generation of leading urologists to become proficient in the use of Robotic focal therapy to manage their prostate cancer patients.

Our placement with Kaiser Permanente Sacramento is also notable, as this is our second placement within this large and influential healthcare network. Kaiser is one of America's leading healthcare providers and nonprofit health plans serving approximately 12.4 million people. We are highly encouraged to see a growing number of Focal One systems being placed within these larger healthcare networks, and we anticipate this positive trend continuing throughout 2025 and beyond.

Our Focal One business in the international markets also continues to gather momentum. In the first quarter, we completed four cash sales of Focal One outside of the United States, which included system placements throughout Europe, the Middle East, and Asia. I will now briefly touch on some key financial and operating metrics for the first quarter of 2025.

We reported HIFU revenues of EUR 6.2 million as compared to EUR 5.8 million for the first quarter of 2024, up 6.8% on a year-over-year basis. Total worldwide revenue was EUR 13.6 million, a decrease of 9.1% as compared to total revenue of EUR 14.9 million for the same period in 2024. As noted on our fourth quarter conference call, the decline in non-core revenue was expected based on the strategic decision to focus exclusively on our high-growth opportunity to become the global leader in focal therapy with our Focal One Robotic HIFU platform.

During the first quarter, U.S. procedures grew approximately 4% over the first quarter of 2024. While the demand for Focal One amongst the U.S. urology community continues to remain strong, over the last few months, we have experienced longer and more challenging review and procedure approvals, especially for patients enrolled in Medicare Advantage plans.

To be clear, this appears to be an industry-wide issue and not one specific to Focal One HIFU therapy. We continue to work diligently with our partners to increase market access and help accelerate pre-authorizations for Focal One HIFU procedures. The recently published HIFU study continues to be instrumental in this process and has already begun to make a positive impact.

As previously discussed last quarter, we believe the recent publication of the landmark HIFU study in European urology will help drive additional Focal One adoption and procedure growth. To learn more about this compelling clinical evidence from this landmark study, I would encourage you to visit the website hifustudy.com, which provides an excellent, easy-to-understand summary of the clinical data. I will now provide a brief update on our clinical programs.

In March, we announced that Focal One Robotic HIFU received CE mark indication for the treatment of deep infiltrating endometriosis. As a reminder, deep infiltrating endometriosis is a severe, chronic inflammatory disease affecting young women of reproductive age and is also recognized as the most aggressive form of this disease. Receiving this CE mark from the European Union notified body represents a significant regulatory milestone, enabling us to proceed with a controlled market entry while we continue to work with endometriosis experts and thought leaders to further refine and expand our clinical development efforts for addressing this disease.

We also believe this milestone represents the first step in enabling women to gain access to this important non-invasive treatment alternative to surgical intervention, which is associated with notable complications, side effects, and extended recovery times. I would now like to briefly discuss some of our recent strategic collaborative activities.

As noted earlier, we recently announced the world's first remote transatlantic Focal One Robotic HIFU procedure. This landmark procedure was performed across a distance of over 7,000 mi between two globally recognized Cleveland Clinic hospitals. Using EDAP's leading Focal One Robotic HIFU system, urologist Dr. Walid Hassan in Cleveland Clinic, Abu Dhabi, managed the patient in the operating room locally, while urologist Dr. Ruben Oliveras in Cleveland Clinic, Ohio, connected remotely to the Focal One system in Abu Dhabi through an EDAP-developed proprietary workstation.

Dr. Oliveras thus controlled the Focal One system in real time from Ohio and collaborated with Dr. Hassan in Abu Dhabi to perform the procedure on the patient. This event represents an important clinical and technological milestone in the treatment of prostate cancer for the Focal One platform, and we would like to congratulate the entire Cleveland Clinic team on this historic event.

We believe this achievement will serve as a first step in a series of continued innovations that will further position Focal One as a leading platform for focal therapy. Longer term, we anticipate remote procedure capabilities will facilitate more efficient and effective training and mentoring of surgeons on Focal One with the ability to broaden patient access to expert care.

Focal One's reputation continues to grow as being the most compatible, scalable, and sought-after technology platform for focal therapy, and we continue to expect additional collaborations in the future as we expand our presence in the management of prostate cancer and into other potential new indications. I would now like to discuss our recent scientific conference activity.

Ahead of this year's recent American Urological Association meeting, the AUA, we partnered with leading academic urology team from the University of Southern California to hold the first-ever masterclass on Robotic Focal HIFU for prostate cancer. This event took place on April 24th and 25th in Los Angeles, two days in advance of this year's AUA meeting. The event was extremely well attended, attracting approximately 100 urologists from 14 countries around the world.

EDAP was the sole sponsor of this event, and Focal One was the exclusive technology presented throughout the program. The Robotic Focal HIFU masterclass was led by world-renowned faculty and featured several live Focal One procedures while offering hands-on Focal One simulation sessions for attendees. Moving on to the important AUA meeting this year, we had our largest presence ever.

As you know, the AUA is the largest meeting in the world focused on urology, and a significant number of presentations were made that highlighted the growing body of clinical data that is being generated from Focal One HIFU procedures. Of particular importance, results from the much-anticipated FARP randomized controlled trial were presented at this year's meeting.

This level one evidence study achieved its primary endpoint and demonstrated that the rate of treatment failure in the focal ablation group is not inferior to that in the radical prostatectomy group at the final three-year follow-up. A total of 213 patients were enrolled in the study, with 107 patients randomized to receive focal ablation and 106 to undergo radical prostatectomy. Results from the study show that the proportion of treatment failure was 6.5% in the focal ablation group, which was lower compared to the 8.5% in the radical prostatectomy group.

As a randomized controlled trial, the FARP trial represents the first level one evidence in support of HIFU therapy and mirrors the positive outcomes observed from larger landmark HIFU study, which also showed that HIFU therapy was not inferior to radical prostatectomy. We believe the cumulative impact from these rigorous data sets all points towards increased adoption of focal therapy for addressing early-stage prostate cancer, and we anticipate a growing number of clinical studies showing the benefits of Focal One will continue to emerge in the major scientific meetings that focus on both urology and prostate cancer.

In addition, this growing body of clinical evidence will be instrumental in further advancing discussions on prostate cancer and treatment guidelines and in positively shaping coverage policies among healthcare insurance carriers. Another major announcement for the company was the launch of the new Focal One i Robotic HIFU system at this year's AUA.

Focal One i represents a significant advancement to our leading Robotic HIFU platform that incorporates a number of cutting-edge technology advancements. These include additional compatibility with the latest diagnostic imaging modalities, AI-based algorithms, along with remote procedure and collaboration capabilities.

The new design of the Focal One i system, along with these additional features, is based directly on the feedback of our customers, as well as anticipating the future needs of surgeons performing focal therapy. I will now turn the call over to Ken, who will review our first quarter 2025 financial results and also touch upon potential implications from recent U.S. tariff activity.

Ken Mobeck (CFO)

Thank you, Ryan, and good morning, everyone. For conversion purposes, our average euro to dollar exchange rate was $1.05 for the first quarter of 2025. Total HIFU revenue for the first quarter of 2025 was EUR 6.2 million, an increase of 6.8% as compared to EUR 5.8 million for the first quarter of 2024. The increase in revenue was driven by six Focal One systems sold in the first quarter of 2025 versus five systems sold in the first quarter of 2024, as well as increases in service-related revenue.

Total worldwide revenue for the first quarter of 2025 was EUR 13.6 million, a decrease of 9.1% as compared to total revenue of EUR 14.9 million for the same period in 2024. The decrease in revenue was due to declines of 23.8% and 17.5% in our non-core ESWL and distribution divisions, respectively. As we discussed on our fourth quarter of 2024 conference call, we expect revenue declines in our non-core segments between 20% and 25% from 2024 levels as we focus on becoming a pure-play market leader in therapeutic HIFU.

Gross profit for the first quarter of 2025 was EUR 5.7 million compared to EUR 6.4 million for the same period in 2024. Gross profit margin was 42% in the first quarter of 2025 compared to 42.8% in the year-ago period. The decrease in gross profit margin year-over-year was primarily due to mixed changes within our product portfolio. Operating expenses were EUR 11.7 million for the first quarter of 2025 compared to EUR 11.2 million for the same period in 2024.

The increase in operating expenses was primarily due to focused investments in our HIFU business segment. Operating loss for the first quarter of 2025 was EUR 6 million compared to an operating loss of EUR 4.8 million in the first quarter of 2024. Excluding the impact of non-cash share-based compensation, operating loss for the first quarter would have been EUR 5.7 million compared to an operating loss of EUR 4.1 million in Q1 2024.

Net loss for the first quarter of 2025 was EUR 7.1 million, or EUR 4.19 per diluted share, as compared to a net loss of EUR 4.5 million, or EUR 0.12 per diluted share in the year-ago period. Inventory decreased to EUR 18 million at the end of Q1 2025 as compared to EUR 18.5 million at the end of Q4 2024. The decrease in inventory levels was due to our ongoing efforts to effectively balance our demand and supply base, along with more efficient just-in-time inventory management with our distribution partners.

Total cash and cash equivalents at the end of Q1 were EUR 22.8 million as compared to EUR 29.8 million at the end of Q4 2024. The decrease was driven primarily by the cash used in operating activities. Respect to the ongoing changes in tariff policies, there was no impact to our first quarter results.

However, based on our latest estimates, we are currently forecasting a 10% tariff impact for all goods transferred from France to the U.S. for the second quarter. As previously noted, approximately 80%-90% of our Focal One components come from France, along with 100% of the Focal One system being assembled in France. We will continue to monitor the potential impact from the Trump administration's tariff policies and adjust our forecasts accordingly.

We continue to monitor our cash flow closely, focusing on working capital management while actively balancing the need to invest and grow our HIFU business. Based on our strategic focus in growing our Focal One business, we are currently considering a broad range of potential financing options that will strengthen our balance sheet and support our market-leading position in therapeutic HIFU. I would like to now turn the call back to Ryan for closing comments.

Ryan Rhodes (CEO)

Thanks, Ken. With respect to guidance, we are reiterating the 2025 revenue guidance, which we first issued on our fourth quarter call in late March. We continue to expect HIFU revenue to grow between 16% and 25% on a year-over-year basis, and the non-core ESWL and distribution businesses to decline between 20% and 25% on a year-over-year basis.

In summary, we continue to focus on our strategic plan in becoming the global leader in focal therapy, and our recent positive announcements demonstrate that we are making progress towards achieving these goals. Demand for our leading Focal One platform remains on a strong upward trajectory, and we believe the introduction of the new Focal One i system will further strengthen EDAP's technological leadership in focal therapy.

As we continue to bring innovation and cutting-edge technology to the Focal One platform, a growing body of clinical data provides additional evidence that supports the use of focal therapy for prostate cancer. We believe the positive results from the landmark HIFU study, coupled with the recent presentation of the FARP randomized clinical trial data at this year's AUA, will accelerate the adoption of focal therapy across the global urology community.

These studies reinforce the oncologic efficacy of Focal One and support the favorable quality of life functional outcomes patients are demanding, as Focal One is a nonsurgical, non-invasive procedure that requires no cutting, no blood loss, and no use of radiation. Finally, when we step back and look at the number of Focal One placements since the beginning of 2022, we are clearly experiencing a steady upward trend in demand that we believe will continue to gain momentum.

As noted, we placed a record number of Focal One systems in the first quarter, and we are seeing growing interest in the Focal One platform from many of the large hospital networks. These are clearly positive signs of Focal One adoption, and we expect this trend will continue in 2025 and beyond. With that, I will now turn the call back over to the operator for questions.

Operator (participant)

Thank you, sir. At this time, if you'd like to ask a question, please press *1 on your telephone keypad. You may remove yourself from the queue at any time by pressing *2, and once again, that is *1. We'll go for our first question from Michael Sarcone with Jefferies. Please go ahead.

Michael Sarcone (Analyst)

Good morning, and thanks for taking our questions. Just to start, Ryan, you commented on some maybe changing trends on the payer landscape, longer and more challenging reviews and procedure approvals. Maybe can you just elaborate some more here? When exactly did you start seeing this? Is it only in the Medicare Advantage population, or are you seeing that starting to broaden out, just trying to get a better sense of what's going on here?

Ryan Rhodes (CEO)

Yeah, the comments and trends that I referenced are relevant to the Medicare Advantage plan patients. As noted, about approximately 54% of patients who are on a Medicare plan will opt for a Medicare Advantage plan or a Medicare Part C plan. We continue to work closely through this process. We're working with one of the largest and most capable consulting firms, and reimbursement and market access has been a core competency for the company.

We continue to see significant progress, and we continue to work through that process with individual payers and certainly with patients. Again, as referenced, it is really in the area of Medicare Advantage that I made comment to.

Michael Sarcone (Analyst)

Got it. I see. Has that continued into Q2, and are you ultimately able to get the procedure approved? It just takes longer, or are you seeing any portion of these processes end up in denials?

Ryan Rhodes (CEO)

There is always the risk of some denials, but we show notable progress of appeals and working through that process, and we see more patients, obviously, winning on the appeal front. Again, we stay very active in the process. We work very closely with the individual institutions, and we monitor it through use of our outside consulting partners. So again, as mentioned, we see obviously more appeals happening, but we win in the majority of these appeals.

Michael Sarcone (Analyst)

Got it. That's helpful. Maybe last one for me, maybe for Ken. You've maintained your HIFU sales growth guidance of 16%-25%. Would love to just get a sense for what's incorporated into those assumptions at the low end and the high end. And are you incorporating a meaningful acceleration in procedure growth? I think you said HIFU procedure growth 4%. Are we assuming in the guide that these payer challenges recede and you get an acceleration in 2H?

Ken Mobeck (CFO)

Yeah. Great question. Thank you, Michael. As you know, capital equipment environment is lumpy. We're holding guidance right now. We do have procedure growth factored in our forecast right now. Where we see the business at this phase, we're still confident that we will achieve in that range between 16%-25% HIFU revenue growth for the year.

Michael Sarcone (Analyst)

Got it. Thank you, Ken.

Operator (participant)

We'll next go to Sean Lee with H.C Wainwright.

Sean Lee (Analyst)

Hey, good morning, guys, and thanks for taking my questions. I just have a couple on the endometriosis front. With the reception of the CE mark approval, what are your next steps on marketing Focal One for endometriosis in Europe? Also, maybe just a follow-up to that, what are your plans for endometriosis in the U.S.? Thanks.

Ryan Rhodes (CEO)

Yeah. As referenced, we have embarked on a controlled market entry in CE mark countries. We're working with a small group of initial hospitals based on receiving CE mark approval. Our goal there is to continue to work with those thought leaders and really expand the clinical development efforts in preparation for a broader launch amongst CE mark countries.

It is kind of a stepwise approach. We are in this first phase, and then we will move to a secondary phase. In terms of the U.S., what we are doing now is, remember, we are following up on the randomized controlled trial, the phase 2 study, or phase 2 study and phase 3 studies, in order to continue to track that data set and monitor those patients.

As we have communicated in the past, there was a high number of patients post the randomized controlled trial that opted to have Focal One ablation for their endometriosis. We want to be able to use that data and carry that data set forward for future interactions with the FDA in the U.S. In the interim, we're working in this controlled launch phase in Europe with our recent CE mark approval.

Sean Lee (Analyst)

That's very helpful. Thanks for that.

Operator (participant)

At this time, we have no further questions. I'd like to turn the call back over to Ryan Rhodes for final and closing remarks.

Ryan Rhodes (CEO)

I want to thank everyone for joining us on today's call, and we look forward to seeing you at the upcoming Jefferies Global Healthcare Conference on Thursday, June 5, in New York City. Thank you.

Operator (participant)

Thank you. Ladies and gentlemen, that does conclude today's program. We thank you for your participation. You may disconnect at any time.