EDAP TMS S.A.

Greetings and welcome to the EDAP TMS third quarter 2022 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keyboard. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, John Francis, Managing Director, LifeSci Advisors. Thank you. You may begin.

Good morning, and thank you for joining us for the EDAP TMS third quarter 2022 financial and operating results conference call. On today's call, we'll hear from Mark Oksakowski, Chief Executive Officer and Chairman of the Board, Ryan Rhodes, Chief Executive Officer of EDAP U.S., and Francois Dietsch, Chief Financial 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 Chairman and Chief Executive Officer, Mark Arkzakowski. Mark?

Thank you, John, and good morning, everyone. I will start by providing a brief operational update before turning the call over to Ryan Rhodes, our ADAPT U.S. Chief Executive Officer, for a review of the U.S. business and strategy. And then François Ditch of TFO will present our financial performance. Let me begin by recapping a few of the highlights. For the third quarter, we generated total revenue of 12.2 million euros, or $12.3 million. representing an increase of 29.7% over the third quarter of 2021. Through the nine months of 2022, we generated total revenue of Euro 39.4 million or $41.7 million, representing growth of nearly 31% over the comparable period in 2021. The increase in quarterly revenue was primarily driven by contribution from our HIFU segment in which we increased revenue nearly 81% over the third quarter of 2021. We sold three Focal One machines during the quarter as compared to one machine in the third quarter of last year. During the first nine months of 2022, we experienced the same high growth of nearly 80% in our global HIFU revenues driven by a strong triple-digit growth in our US HIFU revenues and a solid double-digit growth in our OUS HIFU revenues. We are very encouraged by this notable and global momentum of our HIFU technology. Our distribution segment also performed very well during the third quarter. We sold 12 exact units during the quarter as compared to five in the third quarter of 2021. This drove distribution segment revenue to increase 30.9% year-over-year. During the quarter, positive changes were finalized for reimbursement in the United States. This is great news for access to our leading high-food treatment, and we believe will be a very positive catalyst for our business. Ryan will speak in more detail on these changes in a few moments. Our third quarter and year-to-date results, together with this increase in reimbursement, give us a high degree of confidence that our growth will continue as our HIFU technology is increasingly recognized as an essential platform in urology practices. At this point, I would like to provide an update on our pipeline expansion activities where we believe HIFU can have clinical utility in indications outside of prostate cancer. As a reminder, we are running a phase two study evaluating HIFU using the FOCAL-1 robotic platform for the treatment of deep infiltrating endometriosis. All patient treatments for this study have been completed with the last patient follow-up visit finalized in October. We are now analyzing the database on safety, efficacy, and pathology outcomes with the planning of presenting at a major medical meeting in early 2023. The current standard of care treatment of deep infiltrating endometriosis typically involves surgical resection of the bowel or rectum, which is a highly invasive procedure that presents risk to the patient along a significant recovery time. We believe the use of our FOCAL-1 robotic HIFO technology could greatly improve the treatment of complex endometriosis, by offering patients a less invasive treatment option without the morbidity and possible side effects associated with surgery. We look forward to the results from this important study. On another clinical front, we continue enrolling patients in our BPH, benign prosthetic hyperplasia, feasibility study using our FOCAL-1 robotic HIFU platform. We have so far treated about two-thirds of the number of patients. We will keep you posted as we move forward in this study. In other activities, we strengthened our financial position during the quarter by raising gross proceeds of approximately $23 million through a secondary offering of American depository shares. This financing not only enabled us to strengthen our operational initiatives and further diversify our shareholder base, but also added to our research coverage, which we think will further increase the wariness of EDAP going forward. With nearly $67 million of cash, we are well financed to further expand and continue executing on our U.S. Focal One growth strategy while, in parallel, exploring new indications and other development opportunities. At this point, I would like to turn the call over to Ryan Rhodes, CEO of EWS, for an update on our U.S.

operations. Ryan?

Thank you, Marc. First, turning to the HIFU sales for the quarter, we had a particular active third quarter highlighted by three additional focal one sales. These include Morristown Medical Center in New Jersey, Northwell Huntington Hospital in New York, and Willis-Knighton Health System in Louisiana. Morristown Medical Center is of notable importance as it represents our first focal one sale in the state of New Jersey. Morristown is a leading healthcare provider that has been rated number one in the state of New Jersey by US News and World Report for five years in a row. We would anticipate, like many other highly regarded institutions that have incorporated focal one into the urology practices, Morristown can become an important reference site for us in the tri-state area. Turning to Northwell Huntington Hospital, Northwell Health is New York's largest healthcare provider with 21 member hospitals. It has a very strong reputation as a leading healthcare provider with the ability now to offer focal one robotic focal HIFU to many of its patients. Finally, Willis-Knighton Health System is the largest healthcare provider in Northwest Louisiana and was ranked the best hospital in Louisiana by Newsweek in their publication World's Best Hospitals 2022. These sales are particularly noteworthy as all three represent large community hospitals. We previously talked about the accelerating momentum we are seeing with community hospitals, which make up about 80% of all hospitals across the United States, and these sales further validate that dynamic growth. In parallel with these sales, we also continue to add to our ever-growing pipeline of prospects. With our U.S. team and infrastructure continuing to expand, we believe that we have set the stage for a very active 2023 during which we anticipate converting many of these prospects into Focal 1 sales and placements. As noted previously, the Focal 1 sales cycle can vary by institution and in some cases be quite long with the necessity of working through capital hospital budgetary cycles. We remain confident in the growing awareness of focal therapy led by HIFU as a viable treatment alternative for the management of prostate cancer. Many patients and urologists continue to explore effective, non-invasive treatments beyond the traditional options of radical surgery and radiation. In the area of reimbursement, just a few weeks ago, we learned that the Centers of Medicare and Medicaid Services, or CMS, published its final outpatient prospective payment system rule for calendar year 2023. The final rule increases reimbursement to a hospital performing an outpatient HIFU prostate ablation procedure on a Medicare patient to ambulatory payment classification level six, up from level five currently. In dollar terms, this represents an increase on average of more than 90% to $8,558 per procedure, adjusted locally based on the wage labor index from $4,506 per procedure currently. This new increase goes into effect on January 1. Based on this increase, we believe facility payments will now cease to be a barrier for adoption of Focal One technology. One impact of the reimbursement changes, there have been facilities that have looked to upgrade their focal therapy approach to be primarily robotic HIFU, but had difficulty doing so in the past. We believe this change will help rectify that situation and significantly expand patient access to this procedure. Furthermore, higher Medicare reimbursement often translates into higher commercial reimbursement as many commercial payers follow CMS's lead on such decisions. As noted, we've been successful in driving adoption and sales growth under the existing reimbursement while delivering a positive financial return on investment for hospitals who purchase Focal 1. We now believe the move to classification payment APC level 6 will allow others to acquire Focal 1 robotic focal HIFU technology, thus providing more patients access to these needed and valuable treatments. A recent article in the publication Healthcare Business highlighted the financial success hospitals have led by incorporating FOCA-1 HIFU into their prostate cancer program. This article was authored by Dr. Laura Crescito, Chief Medical Officer and Vice President of the Helen Diller Family Comprehensive Cancer Services at University of California, San Francisco, who is also a practicing urologic oncologist. UCSF is a world-class institution that is widely known for breakthrough clinical research and medical innovation. Here's how Dr. Crescito described the decision to adopt Focal One in the article. I quote her, prior to joining UCSF, I had researched Focal HIFU and I knew this would be a game changer for men with localized disease. It would also round out our cancer services. In fact, It would give UCSF a way to noninvasively treat localized prostate cancer while preserving patients' quality of life and giving them the greatest opportunity to treat their cancer while avoiding common side effects of sexual impotence and urinary incontinence, also associated with standard procedures, radical prostatectomy and radiation. Our proposal exceeded expectations, even though we projected a 2.1-year return on investment. The focal HIFU device paid for itself in the first year. To this day, I consider the acquisition of focal HIFU one of my major contributions to the Helen Diller Family Comprehensive Cancer Center and UCSF, end quote. This case study conveys a very powerful message on the favorable clinical and economic results of Focal-1 and has allowed our US team to amplify its efforts. September was Prostate Cancer Awareness Month, and we participated in numerous events in partnerships with hospitals to raise awareness of Focal-1 robotic HIFU to more patients. We also presented at important medical meetings, such as the 2022 Society of Robotic Surgeons meeting in Orlando, and the 2022 meeting of the Frontiers in Oncologic Prostate Care in Ablative Local Therapy, or Focal 2022, in Los Angeles. Several speakers presented on Focal 1, robotic HIFU, and their experience. In addition, a particularly significant event was urologist-led webinar led by Dr. Timothy Daskovich and Dr. Kyung Kim of Cedars-Sinai Medical Center in Los Angeles. They spoke live to colleagues from across the United States about their experience in adopting Focal One HIFU and presented numerous case studies to assist others in beginning a Focal HIFU practice. In September, we hosted a urology expert panel and live Focal One technology demonstration in New York City that was attended both in person and virtually by over 100 people representing major financial institutions and investors. In closing, the significant investments we have made in building our U.S. team and support infrastructure are paying dividends. With growing awareness and improved reimbursement for focal therapy, we are well-positioned to lead this category of growth with a combination of the most advanced HIFU technology, increased validation with major medical centers, and growing sales and clinical momentum. And now our CFO, Francois Dietsch, will provide some details of our financial results. Francois?

Thank you, 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 1.0017 for the third quarter of 2022. Total revenue for the first quarter of 2022 was 12.2 million euros, a 29.7% increase as compared to total revenue of 9.4 million euros in Q3 2021. Looking at revenue by division, total revenue in the IFU business for the third quarter of 2022 was 3.5 million euros, as compared to 1.9 million euros for the third quarter of 2021, an increase of nearly 81%. We sold three focal one units in the third quarter of 2022 and one unit in the third quarter of 2021. The total revenue in the little business for the third quarter of 2022 was 2.2 million euros as compared to 2.5 million euros for the third quarter of 2021. We sold two lithotripsy devices during the third quarter of 2022 versus three in the year-ago period. Total revenue in the distribution business for the third quarter of 2022 was 6.6 million euros as compared to 5 million euros for the third quarter of 2021. The 30.9% increase was primarily driven by 12 exact year units sold during the third quarter of 2022, as compared to 5 units sold during the third quarter of 2021. Worth profit for the third quarter of 2022 was 5 million euros, compared to 3.6 million euros for the year-ago period. Worth profit margin and net sales was 41%, in the third quarter of 2022 compared to 38.4% in the year-ago period. An increase in gross profits year-over-year was driven by the higher sales effects and fixed costs. Operating expenses were €7.2 million for the third quarter of 2022 compared to €5.5 million for the same period in 2021. The increase was primarily driven by the ongoing build-out of the U.S. team and commercial infrastructure and included €0.4 million of non-cash impact related to share-based compensation programs. Operating loss for the third quarter of 2022 was €2.1 million compared to an operating loss of €1.9 million in the third quarter of 2021. Excluding the impact of the non-cash share-based compensation, operating loss for Q3 2022 would have been 1.7 million euros compared to an operating loss of 0.9 million euros in Q3 2021. Net income for the third quarter of 2022 was breakeven, or 0 cents of euros per deleted share, as compared to a net loss of 1 million euros or 3 cents of euro per diluted share in the year-ago period. As of September 30, 2022, the company held cash, cash equivalent and short-term treasury investment of 68.3 million euros or 66.8 million US dollars as compared to 47.2 million euros or 53.4 million US dollars as of December 31, 2021. In September, we raised gross proceeds of $23 million through a secondary offering of American depository shares. And I will now turn the call back to Marc.

Thank you, Francois.

In summary, we are very pleased with our performance in the third quarter and year-to-date, and I believe this sets up for a very strong end of the year. Both U.S. capital placements, treatment volumes, and pipeline growth continue to reflect the efforts of Ryan and his team, and I believe the increase in reimbursement will significantly amplify the efforts. We will now open the call to your questions. Operator?

Thank you. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary for you to pick up your handset before pressing the star key. Our first question comes from the line of Michael Sarcone with Jefferies. Please proceed with your question.

Hi, and thank you for taking my question. So the first one was just on the finalized Medicare reimbursement. Ryan had briefly mentioned continuing to add to the funnel. I was hoping you could just talk about what kind of impact that finalization has had on your conversations with customers and how they're thinking about system adoption and any kind of quantitative color you could provide just on what that sales funnel looks like and how you think conversion to placement could play out over the course of 2023.

Yeah, so the way I would answer that, a few things. Notably, we work with hospitals commonly with some proforma analysis. And we've done that historically with the current reimbursement, APC level five. So now we have an opportunity to revisit those analysis. And obviously, this looks much more favorable at the facility level. So I think it really does help us, helps us a lot in the community hospital setting. I think what we do have to be aware of is, you know, we normally go through a buying process. Hospitals have those buying processes in place. You know, the question is, do we expedite through that process? I wouldn't say that at this point, but I would say that we look favorable when they do the analysis and they look at reimbursement at a facility level. And I think this does open up more opportunity for us to have more conversations and of course go back and revisit customers we spoke to months ago or a year ago and look at the numbers again. It helps us in that area. It also helps us in other areas of the company to also include our recruiting efforts. I think this is a great story on all fronts, but most importantly, allows for more patient access to this very important procedure.

Great. Thank you. That's really helpful. My follow-up question, can you just give us an update on where you stand in terms of the U.S. commercial organization build-out, whether that be headcount and how you're thinking about that and how you expect to ramp that or if you need to ramp that through 2023?

Yeah, we've made an ongoing effort to add a new headcount and talent in our commercial structure. That is part of our growth plan as we exit the year. We'll continue on that process. but also continue on that process throughout 2023 as we scale up our business. So we've notably added a number of high-talent individuals to the team, and we'll continue to do that as we exit the year and embark on 2023 to take advantage of this new opportunity.

Great. Thank you very much. Thank you.

Thank you. Our next question comes from the line of Jason Bednar with Piper Sandler. Please proceed with your question.

Hey, everyone. Thanks for taking the questions. Maybe just a follow-up there on the reimbursement update and some discussions that were made there in the prepared remarks. What's the right way to think about the very positive update on the reimbursement front? But balance that against conversion cycles that are maybe taking a little bit longer for hospital CapEx items or a lot of hospital CapEx items out there. Are you seeing that, you know, the effects of the macro when you go in and try to close these focal one sales? Or is this just one of those cases where, you know, unique technology, really good reimbursement update, and you're almost going to proceed almost unaffected?

Yeah, so very good question. I think the way to look at it is, first of all, you know, buying patterns certainly vary by institution, by region, et cetera. And we see that commonly. I think when we look at our story and we look at the story of focal therapy, most physicians or urologists in this case would certainly say that this is a necessity to have a focal therapy treatment program or offering. And that, you know, in consideration of looking at what the options are, HIFU now being called out in the reimbursement is a notable option. So again, I think this certainly is helpful in this process and will help us as we look into 2023. But I would also say that when senior executives in a hospital think of focal therapy and they think of HIFU, It is a strategic offering for the institution. If you think of men with, say, intermediate risk disease, what are the best options for them? Well, many will argue that focal therapy should be a consideration. So if you don't have a focal therapy option in your treatment paradigm, you may have a gap. And I think we fulfill that gap with focal therapy, but importantly with Focal One Robotic Focal Haifu. So we're excited about this change in reimbursement. And again, I think it benefits certainly a lot of patients out there who want access to these types of procedures.

All right. Thanks, Ryan. And then maybe over on the clinical pipeline items here, first on the rectal endometriosis indication, I'm really looking forward to seeing that data next year. Can you remind us what we should be prepared to see when that data is presented at the major medical meeting? And then, you know, what are the next steps that you're contemplating for that indication, whether it be in Europe or the U.S.?

So, yeah, I mean, we're looking at evaluating with this study the safety and the efficacy of the treatment on those deep rectal endometriosis nodules. That's what we are expecting to show as the results and the endpoints of that study. Next steps will certainly work on starting a phase three trial, as well as on working on the regulatory paths in both Europe, based on the new MDR regulatory environment, as well as in the U.S. with the FDA. that study should open us some doors to get studied in more concrete regulatory paths.

Okay. Thanks, Mark. Any sense on when that study might kick off, just given the timelines we have in place on the phase two and presentation of that and working through and preparing all the study protocols and then any early sizing, patient enrollment sizing on that study? I'm assuming that would be a kind of a multinational RCT study. Just any clarification on any of those items?

Yeah, we're still working on that and also working with the authorities in Europe to validate and work, build a protocol. So we're not yet there, but we'll keep the market posted.

Okay. All right, great. And then maybe one final point, similar question actually on the BPH study. Any Any timeline on when that study should close? I heard the two-thirds enrollment point, which is a great update. But I'm trying to put a bow on some of the timelines here on these items.

Yeah, it's always difficult to give timing and such information. I mean, you know most of the university hospitals are running a number of clinical studies, so that makes always, as usual, a bit of a challenge to get patients But again, it's going well, so we're confident that we might be closing that potential in the enrollment, at least potentially by the end of this year, if not early next year.

All right, perfect. I'll head back to you. Thanks so much. Thanks.

Thank you. Our next question comes from the line of Frank Takanan with Lake Street Capital Markets. Please proceed with your question.

Hey, thanks for taking my questions. I wanted to kind of follow up on some of the previous questions that were asked. Obviously, the reimbursement doesn't go into effect until the start of the year, but I was just curious if you expect any pull forward into Q4, given your comment around buying patterns and Q4 typically being the strongest quarter for cap placements.

Yeah, we're certainly socializing this with hospitals that were currently in our pipeline and those that may be further distant out. As noted, you know, Q4 tends to be a stronger quarter. We're, you know, obviously guarded optimistic in terms of, you know, where we land end of year. But I think it's really allowed us to go back, as I mentioned earlier, to speak with hospitals that we spoke to maybe months and months earlier in the year or even dating back to last year when we did some perform analysis, especially in community hospitals. You know, looking at re-engagement. And, you know, if you combine the facility payment with the professional fee, it's really attractive on the economic front. Certainly, the clinical merits of the treatment, the procedure, the outcomes, and all that are mission critical. But I think it really does help us. And we're going to take advantage of it where we can as we exit 2022. and March into next year. So we're well-versed at our talk tracks. And again, we're having those conversations currently with our customer base.

Okay. That's helpful. And then maybe one on the commercial side, obviously commercial normally follows CMS's lead, but maybe could you just talk to how we should be thinking about commercial reimbursement for HIFU and when some of these reimbursement changes could come into effect on the commercial side?

Yeah, so again, until that goes into effect on January 1, we'll be doing our best to make sure that the commercial payers are educated. We have a team that helps run a process for any claims that come through. They sit outside the company. They help hospitals. There's an 800 number in the team that helps with that. Again, we'll see probably more of that coming online as we get into the new year, but we are still very active supporting hospitals indirectly on reimbursement related issues and helping where we can. But again, I think you'll see more of this as we move into next year, 2023.

Okay, and then last one, more of a housekeeping question. Can you refresh us around how many focal ones are installed in the U.S.

market today?

Yeah, based on our install base, we're nearly 30 placements, and we added the three here, so it's 27 placements.

Okay, perfect. I'll stop there. Thanks for taking my questions, and congrats on all the progress. Thank you.

Thank you. Our next question comes from Sean Lee with HC Wainwright. Please proceed with your question.

Good morning, gentlemen, and thanks for taking my question. Most of my questions have been answered already, but I just want to have a bit of a follow-up on some of your programs. So first for the U.S. commercial side, would you say there are still any major geographies or medical systems that you have yet to penetrate, or is it more of going back to hospitals that you've talked to before and trying to getting them to see the benefits of HIPAA now that it's a more established therapy?

Well, I think it's both. We're working all the appropriate geographies, the largest MSAs across the country, obviously looking at all appropriate markets. We're doing that in our expansion strategy with our commercial team. Additionally, you know, any hospitals, again, we've had a conversation with in the past. We have made it a priority to get back in front of them and update them on this looming change here coming with reimbursement. That's important. And that allows us to reengage with them, whether it's a pure economic discussion or a combined economic discussion with the clinical value and merits of robotic focal HIFU. So we're excited. It gives us another opportunity to not only look forward to new markets as we're already focused on, but also go back and retroactively look at accounts we've spoken to in the past.

Great. Thanks for the additional color. My second question is on the clinical front. With the rectal endometriosis study, I was wondering, since previously for the prostate cancer, it took a while for APLFM and then FOCAL-1 to be approved because regulators wanted to see longer-term response and longer-term durability data. Is that something that you think they would also be concerned with with rectal endometriosis?

Well, rectal endometriosis and endometriosis in general is a very symptomatic disease as opposed to prostate cancer, that's not as symptomatic as endometriosis, and that's more also a slow-evolving disease. So we might need to get less time of follow-up. And actually, as we previously explained, the phase two trial has a six-month period only of follow-up, which makes it much faster than what it was in the prostate cancer environment. So Of course, we need to bring clinical evidence. And as you know, the EMDR regulation in Europe has strengthened the clinical part of the regulatory process. But again, here, because we are speaking of a very symptomatic disease, we might be able to give and to get conclusions and follow-ups on a much shorter period. I see.

For the potential phase three that's coming up, do you feel like a six-month follow-up will be sufficient then?

So this is, as I said just before, I mean, this is part of the discussions that we are having with the health authorities in Europe to build and get a protocol approved. So we're not yet there.

Okay. Great. Thanks again for taking my questions.

Thanks, John.

Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Mr. Olszkowski for any final comments.

Thank you, operator. Well, that's concluding our call this morning. Thank you again for your interest and support, and I look forward to our next quarterly update. I wish you all a good day. Bye-bye.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.