Greetings and welcome to the EDAP TMS First Quarter 2024 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host John Fraunces. Thank you. You may begin.

Good morning. Thank you for joining us for the EDAP TMS First Quarter 2024 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 Ditch, 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. Following our strong fourth quarter, I'm pleased to report that we continue to maintain our positive momentum through the first quarter of 2024, driven by additional Focal One system placements and robust year-over-year procedure growth, which clearly indicates that adoption of robotic [indiscernible] for the management of prostate cancer continues on its growth path. In the first quarter, we reported total revenue in U.S. dollars of $16.1 million. HIFU grew over 10% year-over-year in Q1 to $6.3 million, which reflects continued procedure growth as well as the placement of new systems. In the quarter, we placed 7 Focal One systems, which included 5 capital sales. Similar to the prior quarter, demand for Focal One is growing across multiple geographies and amongst both academic and community urology practices. We placed a Focal One system with the Thomas Jefferson Hospital in Philadelphia, Pennsylvania. The Jefferson Health Network is comprised of 18 hospitals and physician practices and is the largest health system in the Philadelphia region, by total licensed beds. In addition, the Mount Sinai Hospital System acquired a second Focal One, which further expands our relationship with one of the most widely recognized cancer research and treatment institutes in the world. Mount Sinai Tisch Cancer Center is a well-known center of excellence for prostate cancer under the direction of Dr. Ashish Tiwari, System Chair for the Department of Urology at Mount Sinai Health System. As a reminder, during the third quarter of 2023, we entered into a clinical research collaboration with the prestigious Icahn School of Medicine at Mount Sinai Department of Urology to explore the role of immunotherapy used in conjunction with high food therapy in patients with prostate cancer. And Dr. [Tiwari] will be supervising this exciting and innovative research. We also placed…

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 $1.08 for the first quarter of 2024. Total revenue for the first quarter of 2024 was EUR 14.9 million, an increase of 0.8% as compared to total revenue of EUR 14.8 million for the same period in 2023. The increase in revenue was driven to an increased number of HIFU treatments as well as increased exact [new] unit sales versus the prior period. Looking at revenue by division. Total revenue in the HIFU business for the first quarter of 2024 was EUR 5.8 million, as compared to EUR 5.3 million for the first quarter of 2023. We sold 5 Focal One systems in the first quarter, and we experienced 55.7% year-over-year growth in worldwide disposable based revenues, reflecting strong procedure growth during the quarter. Total revenue in the distribution business for the first quarter of 2024 was EUR 6.9 million as compared to EUR 6.8 million for the first quarter of 2023. The increase in distribution revenue was driven primarily by 11 exact units sold during the first quarter as compared to 8 units sold during the first quarter of 2023. Total revenue in the litho business for the first quarter of 2024 was EUR 2.3 million as compared to EUR 2.8 million for the same period in 2023. The decrease in litho revenue was driven by 2 units sold in the first quarter as compared to 4 units sold in the first quarter of 2023. Gross profit for the first quarter of 2024 was EUR 6.4 million compared to EUR 6 million for the year ago period. Gross profit margin on net sales was 42.8% in the first quarter compared to 40.8% in…

Thanks, Ken. In summary, we have entered 2024 with solid momentum. Our Focal One business continues to expand both with respect to new placements and procedure growth, and our pipeline remains strong, and we now have the most robust externally validated body of clinical evidence, that supports robotic HIFU therapy becoming an essential treatment modality in the management of prostate cancer. And EDAP is exceptionally well positioned to take advantage of this ongoing paradigm shift towards robotic HIPU therapy. With that, I will now turn the call back over to the operator for questions. Operator?

[Operator Instructions] The first question we have is from Michael Sarcone of Jefferies.

I guess, just on the HIFI study, do you think you can talk about or elaborate more on the physician feedback you've received since publication? And then how you think this data is going to impact your conversations with potential customers and Focal One update?

Yes. Thanks, Michael. The feedback has been very, very positive. Again, as noted you look at trifecta outcomes for treating prostate cancer, it always starts with cancer control, followed by the functional outcomes of preserving sexual function and urinary control. And what's exciting about this study, again, it's a non-inferiority study, but we meet a standard, an acceptable standard of oncologic control. And that's been always the question that many urologists have had out there. Can HIFU used appropriately in the right subset of men provide adequate cancer control. So we've received anecdotally a lot of really positive feedback from the urology community. And I think as we look outward, we know patients are seeking highly efficacious treatments that are either minimally invasive or in our case, noninvasive, and we feel that Focal One has the ability to lead in this category of focal therapy. So the positive feedback, again, we -- our capital sales teams and clinical teams, as well as our commercial teams are all excited to charter the message forward, and we've been received favorably amongst customers, both new customers and then active customers who are in our sales pipeline.

Got it. And in the past, there's been a lot of focus on system placements, and you've talked about we need to cross the chasm here. I guess does this data enhance now help you accelerate the timeline for which you can cross that chasm? And with this data, when do you think we could see the inflection in system placements?

Yes. So the data is something we've waited for this study took over 7 years to complete. And again, we have other studies actively referenced, as I discussed on this call. We have the BACO study which also is a randomized controlled trial. But in the interim, we believe this evidence with a large end of patients, over 3,000 patients provides real potential momentum for the company. And importantly, when we get out in the clinical community, as I mentioned earlier, being able to have a proper discussion around the efficacy of use of HIFU for the treatment and management of prostate cancer. So I believe that this absolutely will help us in our narrative. We're early. The study has just come out recently and will be published in the near future in a peer-reviewed journal. So again, we are sharing the information with customers. The response has been highly favorable. If you look at the adoption of -- and sale of systems, we believe this should play favorably in our conversations with physicians, both in the community setting is certainly as well as the academic setting. So we're really excited to have this information and data to get in front of customers, who are interested to know about -- more about the use of HIFU as noted for the treatment and management of prostate cancer.

The next question we have is from Frank Teknon of Leg Street Capital.

Maybe I'll stick with something around the new data as well. I think in previous guidelines is something along the lines of HIFU has been advocated for. But still awaiting adequate long-term data. Does this study satisfy that? And how should we think about maybe HIFU moving into potentially a first-line treatment option in the guidelines?

Yes. Frank, this should certainly help support emerging guidelines. Again, we're written currently into the NCCN guidelines and now the AUA guidelines for use of HIFU in failed radiotherapy, so salvage radio therapy. That is very positive. But as noted, I think we're seeing more evidence coming out from these studies, as noted, that are just going to make it more compelling for updates on guidelines, right? And we know guidelines take a while to update. I mean they tend to lag. The market moves and then guidelines kind of in retrospect, try to are updated. So we believe that this is going to help. We are sharing this information not only to customers, but also out into the payer community. And we think this is really important. And I think we're really at the beginning of seeing more and more compelling data coming out supporting the use of robotic HIFU in the treatment of a subset of men who have been diagnosed with prostate cancer. And I'd say from a patient perspective, patients are looking for a highly efficacious treatment that allows them adequate cancer control that maintains the functional outcomes, very important functional outcomes are preserving sexual function and urinary control. And so we now have something with data that we can offer patients that is not invasive. And we're just really excited to charter the message forward. And as mentioned, we are sharing this actively with customers on a daily basis.

Perfect. And then maybe just changing -- switching gears to thinking about 2024 expectations and placement expectations. I think last year, the cadence was something along the lines of 7 placements in Q1, then 4 in Q2, 2 in Q3, 10 in Q4, 12 total placements, 10 sales in Q4. Is that the right cadence to be kind of thinking about for this year with some growth? Or how should we think about placements, seasonality and recognition of revenues throughout 2024?

Yes. Well, we continue to see a growing pipeline. Our active pipeline grows amongst our sales teams. And again, I think looking out where we, again, continue to see growth in higher interest in the technology. We haven't given guidance, but it would be important to note that we see a growing interest pipelines as noted, are growing amongst our capital sales team. And I think the numbers you socialized feel correct in some manner. We may get seasonality sometimes in the third quarter. We tend to have a stronger back half of the year as noted. And I think we'll see a similar pattern this year. But we're excited. I mean we're now at -- in Q2, but I think there's good momentum as we look through the rest of 2024.

The next question we have is from Jason Bednar of Piper Sandler.

Nice start to the year here, guys. Ryan, would love to start with you just on probably another question here, just following up on AUA. A lot of good data, HIFI looks like it should be pretty impactful. Two questions, maybe to start from here. I know you referenced the meeting being a record on a number of fronts, [indiscernible], you have had at the meeting. For prospective Focal One users, wondering if you can put the interest in context of past AUA meetings or relative to your own internal expectations? And then the second question is maybe somewhat related to what Frank was just asking. But anything you can draw from past AUA meetings regarding how you can use interest from the meeting as a guide or indicator of future demand, really trying to get a sense of how you see AUA influencing growth of Focal One units this year, after you got off to a real nice start with placements in sales in the first quarter?

Yes, Jason, thank you. So first, as noted, AUA was a resounding success for the company, and I say that from the perspective that we had a very large showing, our largest showing ever. We were highly visible throughout the meeting. As noted, we had numerous presentations given in our booth. As mentioned also, the HIFI study data was presented. The other studies I referenced in the narrative on this call. So I would say, for those who have not had belief in use of HIFU, I think we see a bit of a turning point that, wow, focal therapies in play. We understand the role and value of focal therapy. Then the next question is, how do we best deliver focal therapy? And I think we point back to the fact that we offer a robotic platform that delivers a precise HIFU ablation to targeted structures and anatomy. And part of the gem of AUA is you get the intimacy with customers, but you also get the ability to show them what a treatment looks like. And throughout the AUA meeting, we were doing simulations. Those are where -- where we sit down with doctors and we set up a treatment plan and show them how straightforward it is, to use the imaging capabilities within the Focal One system and all the other interactive benefits the machine and technology offers them. So I think looking at this AUA, we were the busiest we've ever been. And I can tell you, I mean, at least in the last 3 years that I've attended AUA for EDAP. We've gotten bigger every year. And I would say the buzz was very high this year at AUA. And many had heard about the HIFI study. We were presenting study data in our booth. And I think if you look outward, again, it'd be fair to say there is demand growing and more awareness. It starts with awareness first, you need to create awareness in order to create demand. But I think the HIFI study at the AUA and also presented at the EAU meeting in Paris, the second largest urology meeting in the world. If you think about it, these two major meetings showed a very high impactful study using exclusively EDAP's HIFU technology. And again, we're going to be speaking more and more as we look out to more interested customers, and we follow up on leads from the meeting.

All right. All right, helpful. maybe shifting bigger picture, hospital CapEx environment in the U.S. at unique right now, procedure volumes are pretty darn strong. That's usually a positive read for spending on high-ticket capital, but the counter is that interest rates and financing maybe aren't as accommodating. So are you seeing the impact of the latter there -- this higher for longer rate environment. Is that shifting sales discussions at all, leading to any kind of deferrals or changes in moving forward? Or are your capital sales and the commercial discussions really operating independent of financing considerations?

That's a great question. It would be fair to say that, again, hospitals today are making still notable investments both in operational capital and strategic capital. What's important for people to understand is that, we really fall into that strategic capital bucket. And what I mean is we're selling a clinically necessary strategic revenue-enhancing service line, okay? We have a CPT code. We have proper reimbursement, both for the facility and for the physician. So on the economics, it's very valuable, and it's for a very valuable patient. We're talking about a prostate cancer patient, which is core to men's health. So when we think of hospitals and we engage with -- some will take longer in their buying cycles. As you know, value analysis committees and whatnot, they have a mechanism to look at capital in the right way, capital investments and be able to think of which ones they want to prioritize. I think if you look at our story, it's very strong in the sense that it's tied to a major cancer that affects men all over the world. And now we have a solution with data that supports it. I think when we come to the financing discussion, I would say today, you have to be prepared for anything in those conversations. And what I mean is, there's various forms of leases, subscription models, bridge to buy these kinds of things. We have a full offering that we propose in front of our customers. Typically, they may ask for something, and we will provide them guidance using one of these financing tools. And that allows us to be flexible with them. I think that the takeaway message today in capital equipment, especially premium price capital equipment is you need to be flexible. And I believe we're well armed with the right flexible financing tools to be able to answer to that. And -- but with that said, some of the cycle times for purchasing capital equipment can take longer. We've seen that process being longer than shorter in many cases. But the interest is there on the hospital to make the investment, and we answer as noted.

Yes. And Jason, just to follow up on that. When we look at our active pipeline today and where we drop those in our forecast, what we're seeing is it's just taking the hospital more time, to go through all the buying mechanics to actually purchase the system, right? We're not losing deals in our pipeline. They're just taking longer to revenue.

Just if I could squeeze one more in there. Any sense of like what that lengthening is and whether it's -- you can quantify like on average, it's being delayed by or it's longer by 3 months or 6 months or just what that looks like?

I mean really -- Jason, it really varies. I mean, we've seen some sales can take many months to get done. Others can come quickly. I think behaviors are different. The community hospitals tend to move a bit faster in many cases. When you have the right story and they are leaning in and listening and understanding the value and utility of what we can bring to the hospital, they're sitting down with us, and we're working through the process shoulder to shoulder. So we -- as Ken mentioned, deals can vary in cycle times. Some hospitals we notice can move quickly. Some can take longer. It's hard to put a real number on it. I think you'll see variability. I think the best thing from our perspective is we -- as I mentioned, we are offering something that is clinically necessary and strategic, that brings them immediate economic reward. And so we don't have those headwinds. And so typically, when we sit down with them, if they do a pro forma analysis, we work very closely with them. And if they need some flexible options in financing, we're able to provide those options.

The last question we have is from Swayampakula of HC Wainwright.

So then when I look at your numbers, it looks like some of the procedure volume continues to increase. And coming out of the AUA conference and the HIFI presentation, do you get a feeling for how entrenched the HIFU system is in the centers that you've already placed? So I'm just trying to get a feel for like -- do you foresee any increase in procedure volume based on the presentations and also your feedback that you're getting from the docs who attended the conference?

Yes. R.J., we've gotten really good feedback. I think what we see is that when we approach a hospital, we talk about building a program. So a program is not unique to necessarily one urologist. We -- I think today, we do a much better job of socializing what the value of adding a Focal One Robotic HIFU program can mean to a hospital. So with that said, I think we have more interest in neurologists being trained in use of that technology. So in our existing installed base, once the system is placed, we launch our program, and we may train other urologists, and we're ready to do that, usually, there's a plan, a step-up plan. And so, I would say that we are active supporting our hospitals, amongst our clinical team to execute on that plan. I think as I mentioned, if you think of HIFU, it's used in primary treatment, which is a large audience of patients, there's a lot of opportunity out there. So I think we're very early in this adoption curve that is even with hospitals that provide HIFU today. So the hospitals that have had their system for a while tend to get busier in most cases, as you would expect, they're using machine more frequently. Or in the case of expanded indications, like I had mentioned, the new guideline change for salvage use of a HIFU, for salvage [indiscernible] radiotherapy, that can be a new market segment for hospitals to consider. As we know there's radiation failures out there and patients need to have all options presented to them. So I think we're just in the beginning of seeing trends and be able to see growth, as more hospitals use the technology, maybe use it on a more frequent basis as noted, or even train new urologists who have strong interest of learning use of Focal One HIFU. So again, I think we have a lot more to do in terms of growth, and we're very early in the adoption of this market.

Very good. And then on the endometriosis front, you expect data to be released from the Phase III study, in the second half. I'm just trying to understand what's the game plan beyond it? And what should we actually expect in that initial release of data in the coming months?

Yes. So again, a couple of things. We've shared the Phase II study has been submitted for a publication. So that's something exciting that is out there. The Phase III study results should be available sometime in the second half of the year. But I think the most important thing here is we are taking advantage of the breakthrough designation, given to us by the FDA for use of Focal One in deep infiltrating endometriosis, meaning that we are now actively in a plan with the FDA to work through the necessary process to receive clearance at some future date. So we have data now that we can use from these studies, and that was part of this breakthrough designation application. We can use this data effectively, and we are now in that process of interacting with the FDA to move forward to receive clearance at some future date. We have -- are working through that, and our teams are exceptional working on this project. So I think that's the more exciting news there is that we're embarking on that process. We are also, at the same time, working through MDR and CE Mark through those markets in Europe. And so we run these in parallel paths. So I'm very excited as we look outward and we'll have more data to share here in the near future.

If I can squeeze in a quick question on the international markets. You gave some metrics in terms of the placements in U.S. How do you see that ex U.S. market growth from here onwards? I know there's a lot of focus in the U.S., but the ex U.S. market could easily become as interesting down the line.

Yes. Great question. We saw a lot of interest from people who attended both the EAU meeting in Europe, quite a bit of interest. We were very busy in Paris at that recent meeting, as well as international attendees who came to AUA. So the interest is very high. I'd say a couple of things. We see more centers outside the U.S. As mentioned, we have sold our second system into Taiwan. But when you think of Europe, we, last year, received reimbursement in Switzerland in July. So there's a market opportunity. We have the economics, we have clinical value. We have the right product, there's an opportunity there. Also, we socialized openly that the French high authority, which was part of the endorsement of creating and supporting the HIFI study, this -- the HIFI study was done with the intention of receiving near future reimbursement in France. So again, we're working through that process or waiting for that process. It's outside the company. But we believe that there will be a reimbursement opportunity at some future date in France. And so these are just some small sound bites that play into the narrative. I think we're seeing more interest from international physicians. They look at what's going on in the U.S. and they tend to look over their shoulder and see that HIFU is being adopted, and our results are excellent. And so with that said, we'll see probably more activity over time here, growing as well in the outside U.S. markets.

Thank you. That concludes the Q&A session. And I would like to turn the floor back over to Ryan Rhodes comment.

I want to again thank everyone for joining us on today's call, and we look forward to seeing you at the upcoming Jefferies Healthcare Conference in New York City from June 5 to June 6.

Thank you. Ladies and gentlemen, that concludes today's conference. Thank you for joining us. You may now disconnect your lines.