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spk06: Greetings and welcome to the EDAP TMS fourth quarter and full year 2022 earnings conference call. At this time, all participant lines are in a listen-only mode. A brief 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 keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, John Francis, Managing Director of LifeSci Advisors. Please go ahead.
spk01: Good morning. Thank you for joining us for the EDAP TMS fourth quarter and full year 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-US, 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 Oksakowski. Mark?
spk02: Thank you, John, and good morning, everyone. I'll start by providing some operational highlights of our fiscal year 2022 and then turn the call over to Ryan Rhodes, our EDAP U.S. Chief Executive Officer, who will review our U.S. business and strategy. Our Chief Financial Officer, Francois Ditch, will then present our financial performance. Thanks to the continued hard work of our dedicated employees and the growing acceptance of our technology, 2022 was a great year for setting new records at EDAP. During the fourth quarter, we generated record revenue of 15.7 million euros or 16.2 million dollars for the year. and we announced record revenue of 55.1 million euros, or 58 million dollars, representing year-over-year growth of over 25%. Without question, our strong top-line performance was driven by our high-intensity focused ultrasound, or HIFU, segment that grew by 58% compared to 2021. The HIFU growth was particularly strong in the U.S., as Ryan and his team continue to execute by expanding the number of medical centers that are now using our therapeutic ultrasound solution, focal one, robotic focal HIFU. As the global leader in therapeutic HIFU, EDAP enjoys a significant technology advantage in the marketplace. And we continue strong market execution. We anticipate momentum in the form of increased system placement and utilization will continue throughout 2023. Our distribution segment also performed very well during the fourth quarter. We sold 11 executive units during the quarter as compared to nine in the fourth quarter of 2021. This is concluding a strong year for the executive business as we doubled our system sales as compared to 2021. I'd now like to provide an update on our pipeline where we continue to make significant progress in demonstrating the utility of therapeutic HIFU beyond prostate cancer. In January, we announced positive clinical results from the endo-IFU phase 2 study, evaluating the safety of therapeutic HIFU for the treatment of rectal endometriosis. Results from the trial served to validate the safety of 4.1 HIFU treatment in this difficult and challenging endometriosis population. The study enrolled 60 patients across four centers in France between August 2020 and March 2022. and the results were based upon a six-month follow-up evaluation post-HIFU treatment. Study coordinator, Professor Gilles Dubernard of Croix-Rouge University Hospital in Lyon, France, presented results from the study on January 27 at the Paris Centre Femme French Congress in Lyon, France. As previously announced, treatment with 4x1 resulted in significant improvements in endometriosis symptoms and quality of life. In addition, the treatment had a very positive safety profile with 96.7% of patients with no or non-significant adverse events. Finally, the study also blindly evaluated the evolution of nodule volume via MRI, and a significant reduction of the volume of lesions was observed at six months. Based on this positive safety and preliminary efficacy data, We intend to compare the efficacy of FOCAL-1 high-food treatment in rectal endometriosis by initiating a Phase III study in the second quarter of 2023. As a Level I study, this trial will be a multicenter, double-blind, randomized, controlled clinical trial that will enroll 60 subjects across 8 centers in France, with 30 subjects randomized to each group. The primary efficacy endpoint is acute pelvic pain three months post-procedure. If successful, this rigorously designed study will provide a strong clinical evidence to date demonstrating the utility of therapeutic high proof to address this painful and debilitating condition. As a reminder, the 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 with significant recovery time. We believe the use of our focal one robotic hypotechnology 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. As we execute our On our commercial strategy and grow our pipeline, we are doing so from a position of increasing financial strength. We ended the year with $67.5 million in cash, which was practically unchanged from the prior quarter. As our business continues to grow, both with respect to increased system placement and higher utilization, we expect to maintain a strong balance sheet while making an appropriate level of investments to further drive top-line growth and expand operating margins. As announced earlier today by our press release, the Board of Directors decided to change the leadership of the company to further develop ADAPT's global growth strategy, focusing particularly on its continued extension in the United States and in the rest of the world market. The board has therefore appointed Ryan Rhodes, Chief Executive Officer of CDAP TMS, effective May 1st of 2023, to lead, strengthen, and accelerate this important global commercialization strategy. The company has now reached an important inflection point in its growth trajectory and needs a strong, focused, and aggressive strategy to be executed. The board of directors and myself are confident that Ryan has the capability, the experience, and skills to lead this new and higher state of development for EDAP and high-speed adoption. I am pleased and committed in continuing to serve as chairman of the board of the company. At this point, I would like to turn the call over to Ryan Rose for an update on our U.S. operations and activities. Ryan?
spk05: Thank you, Mark. I first want to say thank you to both Mark and all the EDAP board members for their confidence in my abilities to lead EDAP as the worldwide CEO. As stated, we are focused on an important mission of growth to expand both in the U.S. and in outside U.S. markets. I take personal pride in leading our global teams as we embark together in alignment to further establish EDAP's strong position in the markets. As a global leader in therapeutic HIFU, it is becoming increasingly clear that EDAP's technology leadership, product offering, as well as customer support and distribution capabilities are all translating into increased recognition of FOCAL-1 robotic HIFU as a leading non-invasive treatment option for men diagnosed with prostate cancer. As a result, we continue to see ongoing market momentum across our U.S. business. The fourth quarter of 2022 clearly reflects this momentum as we completed a record of nine focal one transactions, which included six unit sales and three operating leases. As we continue to demonstrate our technological leadership in therapeutic HIFU, we also expect to benefit from higher levels of reimbursement for focal one procedures. As touched upon earlier, last year the Centers for Medicare and Medicaid Services, or CMS, released the Outpatient Prospective Payment System final rule on October 31, 2022. The final rule confirmed the upgrade of Medicare hospital payment for prostate HIFU to ambulatory payment classification level 6 from level 5 previously, which translates to increase reimbursement of approximately 90% to on average $8,558 per procedure. This appropriate increase in reimbursement officially went into effect on January 1st, 2023 and should further serve to help drive a positive assessment of cost and ROI to centers who invest and offer focal one procedures to their patients. As noted on our prior call, but bears repeating, higher Medicare reimbursement can oftentimes result in higher reimbursement from commercial payers who typically follow CMS's lead on such decisions. Also, as the global leader in therapeutic HIFU, we are constantly engaged in a multi-pronged strategy of educating clinicians, patients, and providers on the benefits of our technologies. Attending major medical meetings, publishing peer-reviewed clinical data, and sponsoring webinars and symposia are each critical components to this strategy. During the fourth quarter, we attended several noteworthy meetings, including the Society of Urologic Oncology, SUO, meeting which was held in San Diego in early December. The SUO has a large group of leading neurologists, His mission is to collaborate in the care of patients with malignant genitourinary diseases, including patients diagnosed with prostate cancer. EDAP had the largest showing ever as a main exhibitor, giving numerous hands-on treatment simulations highlighting the use of FOCAL-1 robotic hypho. In the area of clinical publications, On October 26, 2022, researchers led by Stefano De Luca from the University of Turin, Italy, published a paper in the peer-reviewed journal Minerva Urology and Neurology entitled MRI Real-Time Ultrasound Image Fusion Guided High-Intensity Focused Ultrasound, HIFU, a Prospective Comparative and Functional Analysis of Different Ablative Techniques. Highlights of the publication included the results from 100 patients who were treated with Focal One robotic HIFU, all having a follow-up control biopsy at one year post-treatment. The paper noted that 82% of the patients showed negative biopsy upon follow-up at one year. That's demonstrating excellent short-term cancer control. Also, the paper noted the procedural efficiency delivered by Focal One's proprietary dynamic focusing technology coupled with the system's robotic capability, which resulted in operative times of only 55 minutes on average. Additionally, we hosted two high-impact peer-to-peer webinars in the fourth quarter, led by leading academic urologists from the University of California, Los Angeles, UCLA, and the University of Miami. One webinar was focused on the use of XACU micro-ultrasound for targeted prostate biopsy presented by Dr. Wayne Brisbane of UCLA. The other webinar was led by Dr. Bruno Nahar from the University of Miami, highlighting the role of VOCAL1 robotic HIFU technology in the management of prostate cancer. These webinars provide an excellent venue for thought leading clinicians to present important new data and outcomes
spk09: to a wider physician audience who are interested in adding these procedures to their clinical practice.
spk05: As we look outward, EDAP will be hosting the first worldwide livestream broadcast of a FOCAL-1 robotic high-flu procedure performed by Dr. Andrea Baru and Dr. Amir Labachi from the University of Southern California, USC, Keck School of Medicine. This exciting global event will take place on April 18th at 12 noon Pacific time. Please all plan to watch. For more information and to register, please visit focal1.com. Another important event will be EDAP's participation at the upcoming meeting of the American Urological Association to be held in Chicago, Illinois. from April 28th through May 1st. The AUA is the largest gathering of neurologists in the world with a defined focus in providing the latest advances in neurologic medicine. EDAC will have its largest presence ever while exhibiting during this important scientific congress. We would certainly encourage any of our investors as well as interested clinicians to stop by our booth and to see our focal one robotic high-through technology in action. Looking ahead, I remain very optimistic about our sales pipeline and our team's ability to execute. As of today, we were extremely busy and active in closing the last days of the first quarter. As such, we continue to see positive momentum with customer engagement and a strong interest from new customers and obtaining Focal-1 robotic HIFU. In closing, I believe EDAP will continue to build on its ongoing success throughout 2023. And now, our CFO, Francois Dietsch, will provide some details on our financial results. Francois?
spk10: 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 1.0302 for the first quarter of 2022. Total revenue for the first quarter of 2022 was 15.7 million euros, a 12.5% increase as compared to a total revenue of 14 million euros in Q4 2021. Looking at revenue by division, total revenue in the IFO business for the fourth quarter of 2022 was 5.4 million euros as compared to 4.2 million euros for the fourth quarter of 2021, an increase of nearly 28%. We showed seven focal one units in the fourth quarter of 2022 versus five in the fourth quarter of 2021. Total revenue in the liquid business for the first quarter of 2022 was 3.6 million euros as compared to 3.3 million euros for the first quarter of 2021, a 7.5% increase year-over-year. We showed 11 literacy devices during the first quarter of 2022 versus 9 in the year-over-period. Total revenue in the distribution business for the first quarter of 2022 was 6.7 million euros as compared to 6.4 million euros for the first quarter of 2021. The 5% increase was primarily driven by 11 executive units sold during the first quarter of 2022 as compared to 9 units sold during the first quarter of 2021. Gross profit for the first quarter of 2022 was 7.2 million euros compared to 6.2 million euros for the year-ago period. Gross profit margin and net sales was 45.9% in the first quarter of 2022 as compared to 44.5% in the year-ago period. The improvement in gross profit year-over-year was driven by the higher sales effect on fixed costs and the development of the iFood division, which has better margins. Operating expenses were 8.9 million euros for the first quarter of 2022, compared to 5.8 million euros for the same period in 2021. The increase was primarily driven by the ongoing build-out of the U.S. team and commercial infrastructure. Operating loss for the first quarter of 2022 was 1.6 million euros compared to an operating income of 0.5 million euros in the first quarter of 2021. Excluding the impact on the non-cash share-based compensation, operating loss for Q4 2022 would have been 0.8 million euros compared to an operating income of 1.2 million euros in Q4 2021. Net loss for the first quarter of 2022 was 5.1 million euros, or 15 cents of euro per deleted share, as compared to a net income of 1.4 million euros, or 4 cents of euro per deleted share in the year-ago period. As of December 31, 2022, the company had cash and cash equivalents of 63.1 million euros, or 67.5 million U.S. dollars, as compared to 47.2 million euros or 53.4 million US dollars as of December 31, 2021. I will now turn the call back to Marc.
spk02: Thank you, Francois. In summary, our strong fourth quarter results reflect increasing demand for our leading therapeutic HIFU solution, which addresses early to intermediate stage prostate cancer patients. This dynamic coupled with significant improvement for reimbursement from CMS, will support our continued growth and expansion throughout 2023, as Ryan's team continues to introduce Focal One to an increasing number of urology practices and cancer treatment centers in the U.S. I'm glad the company is now embarking in a new era of leadership, which I am confident will bring its development and the adoption of HIFU to the next level. We will now open the call to your questions.
spk09: Operator?
spk06: Thank you. Ladies and gentlemen, at this time, we will be conducting a question and answer session. If you would 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 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we'll wait for a moment while we poll for questions. Our first question comes from the line of Michael Sarcone from Jefferies. Please go ahead.
spk04: Hello, and thanks for taking my questions. First, I'd say, Mark, congrats on many years of successful execution, and Ryan, congrats on the new role.
spk05: Great, thank you.
spk04: You're welcome. And I guess just to start, you know, for Ryan, you know, as you think about transitioning to the new role, can you just give us an update on how you think about strategy, where the company is now, and, you know, what you will reinforce versus where you might change course?
spk05: Yeah, I think from the strategy standpoint, obviously, you know, looking at our playbook in the U.S., and our momentum and strategy there, and does it cross-pollinate into outside U.S. markets. So I think looking at how we can bridge some of that success and bring it to regional markets outside the U.S. Obviously, a high focus is where we don't have current distribution or approval yet to sell our flagship product, Focal One. That will be a high priority in those markets. Equally important, Our distribution business continues to perform well for us. And I'm excited when I look at our micro ultrasound product, ExactView, and where it can grow in various country markets where we're starting to distribute and or sell that product. So I think a lot of it in closing is going to be taking kind of lessons learned from our markets in the U.S., and seeing where we can make an appropriate fit in outside U.S. markets and work closely with our teams broad-based on driving a plan of success.
spk04: Got it. Okay, thank you. And, you know, just one on the sales funnel in the U.S., you know, can you talk about how that's shaping up so far? You mentioned customers continue to indicate strong interest. I was just curious if you could elaborate a little more on that, you know, the different types of accounts, maybe the size of those customers expressing interest and how you're thinking about system placements in 2023.
spk05: Yeah, so again, we see continued interest. Our pipeline is growing. And we see interest not only in the academic centers, and we've shown that we can sell effectively in those centers, But equally, we see the uptick in interest in community-based hospitals. So we work them both categorically. And whether large or small, we look for early adopters that want to take advantage of the market momentum building around focal therapy. And again, we continue to add salespeople to our ranks. Our numbers are going up on the sales side, at least in terms of sales executives. and as well as our pipeline growing. We're winding down the first quarter, and I can say we're delivering on the promise, meaning that we are delivering on the momentum we would expect to see as we embark on a strong 2023. We will continue to drive the market and take advantage also of the new reimbursement that went into place January 1.
spk04: Great, and then just one last one from me. It doesn't sound like you're seeing any of this, but do you have any hospital, large or small hospital customers that express some hesitancy around capital equipment expenditures? Just trying to get a sense for what you may be seeing there in terms of either hospital margin pressure and hesitancy to spend on a large ticket item.
spk05: Yeah, well, I think all hospitals will do their due diligence in terms of the economics. I think, again, as we've done in the past, we've been effective selling our technology to hospitals with the older reimbursement, call it. With the new reimbursement that went into place January 1, when the proforma analysis is done correctly, adding VOCA1 robotic HIFU, they can show an immediate return on an investment. And so we behave differently, I think, in the capital equipment space. First of all, it's a clinical necessity today to be considering focal therapy as an offering for men diagnosed with prostate cancer. Equally, the advantages with our technology and making the investment in the equipment, specifically HIFU, can generate benefits newly incremental patients to that individual hospital catchment market and pay well for the provider, that is the hospital, as well as the physician. So if there are market pressures, and I can't comment really on those, I can comment that our economic return is pretty much immediate, and we've shown that even with the prior study that was done by the University of California, San Francisco, where they were able to pay back their system in year one after obtaining it. So again, we work closely with hospitals to do these analysis, but we have not seen anything particular in terms of a broad hesitation to purchase disruptive capital equipment.
spk09: Great. Thanks so much for taking my questions. Thank you, Mike.
spk06: Thank you. Our next question comes from the line of Joseph Calming from Piper Sandler. Please go ahead.
spk08: Hey, guys, and good morning. I'm on for Jason today. Thank you. Congrats, Brian, on the transition. First, starting with guidance, I know you guys didn't provide anything formally for 2023, but the street's modeling around 15% revenue growth for the year. Is that a level you guys are comfortable with for the full year?
spk05: Yeah, I don't think we provided any guidance. You know, I think, you know, again, we're looking, you know, specifically I'm talking on behalf of the U.S. side. Again, we continue to see market momentum. We're building our pipeline. We're adding salespeople. We're executing with high discipline. And, you know, we're following the playbook and roadmap that we've established for the U.S. Maybe, you know, I don't think anything is changing abnormally in outside U.S. markets.
spk09: Yeah, absolutely. Yeah.
spk08: Great. Yeah. And then just moving to gross margin here, staying on the 2023 track. So forecasting gross margin has been a bit of a challenge given the lumpiness that comes with focal one sales. How would you have us think about the trajectory for gross margins in the HIFU segment as we look over the next one to three years? And how much opportunity do you see for gross margins to move higher? And are you able to give us a sense what the incremental margins are on each Focal 1 unit that might be sold in a given quarter?
spk02: Well, actually, we don't provide numbers by equipment sales, but as we explained several times, the overall gross margin with the company will continue to increase as we increase our level of sales of Focal 1 and HIFU activities. in particular, as it generates the highest rate of margin for the company. And again, we saw that this year with a strong increase in our HIFU business revenues that has helped increase the gross margin. So that will certainly continue the trend as we continue to grow the business of HIFU worldwide.
spk08: Understood. Thanks. Just one more from us. On the commercial reimbursement side, What's a reasonable timeline in which we could expect commercial payers to follow suit and bump higher their payment rates on prostate cancer treatments with HIFU? I guess generally, is this a 2023 dynamic or do we have to wait here until around 2024 or beyond?
spk05: So we do have commercial payers today paying for HIFU treatments. We track that and work closely with our customers and the payers. Currently, you know, we have a plan, certainly as we do more procedures and grow the visibility, that we're looking for new guideline changes. And we had notable change in language last year from the American Urological Association. And, you know, that kind of momentum in their language change is very helpful. But I think looking outward, We will continue to see more data coming out supporting the efficacy of HIFU for men diagnosed with prostate cancer. And equally, looking for coverage policies from some of the larger payers over time. It's really hard to pinpoint an exact timeframe, but we have a roadmap in front of us, and it affects us as well as others in the market. but we're cautious and very optimistic that over time we'll see improvements in terms of new guidelines as well as extending coverage policies across some of the largest payers.
spk09: Perfect. Thanks, Ryan and Mark. Really appreciate it. Thank you. Thank you.
spk06: Our next question comes from the line of Frank Takanan from Lake Street Capital Markets. Please go ahead.
spk03: Hey, thanks for taking the questions, and I'll also echo my congratulations. Maybe to start with one more on the comment you made about continued momentum through the first quarter of the year. I think last year in the first quarter of 2022, you had something like three transactions. You had nine transactions in the fourth quarter of 2022. Can you maybe speak directionally versus those metrics, how you're feeling the placements could shake out in the first quarter of this year?
spk05: Yeah, so Frank, usually Q4 obviously is a strong quarter for most companies, inclusive of us, so we finish the year strong. there is the seasonality coming off the end of the year and then kind of ramping your growth throughout the following year. So I think we're off to a very good start for 2023. We're still a few days away from closing the quarter, but I think directionally we're heading in the right direction. We have a good playbook and plan we're executing on. The team is working hard. So, you know, again, we would continue to kind of follow the patterns, of growth that we would have probably seen early on last year. And again, we still got a couple more days here before the quarter ends, and we're working hard to close every sale.
spk03: Got it. Okay. That's good color. And then secondly, I wanted to ask on your comment of positive momentum in the advancement of U.S. society guidelines with focal ablation in the press release. I think you spoke about this to some extent throughout the call today, but was hoping you could speak about that a little bit more in depth and maybe talk about the impact of the recent data announced a couple weeks ago and how that could influence those guideline decisions and conversations.
spk05: Yeah, so again, we see more data coming out, and I'll talk about that. I mean, the HIFI study, which was published a A study that has been under the authorization of Professor Richman is showing very good oncologic control results comparatively to surgery. So again, we're seeing more of this data coming out, these studies, as well as the randomized clinical trial that is still underway in Norway, again, showing the efficacy and showing the results around oncologic control. We, you know, we're excited because we think those studies are performed with high discipline and we would expect those results to, you know, continue to be reproducible out in the markets. So in terms of guideline development, you know, we have a notable install base of leading cancer centers. And so, you know, one of our missions is to work closely with them and see where they can possibly, through the data that they're tracking, be able to use some of that data to help shape and build new guideline changes. And again, things like reimbursement on the commercial side, as brought up earlier, will be influenced as the volume of procedures increase. And again, we continue to drive increases in our procedure volume. So that's another data point as we look to impact either guideline change and or reimbursement change at a commercial level.
spk03: Okay. And then last one, I was hoping you could comment on any utilization trends you're experiencing year to date since the implementation of the new reimbursement regime. And then if you could also touch on any expected ASP changes specifically within the consumable piece of the sale.
spk05: Yeah, so since going back to the – can you repeat that question again?
spk03: Just utilization trends of what the systems are. Yeah, and if under the new reimbursement that's gone into effect at the beginning of this year, if you've had the ability to raise price at all on the disposable.
spk05: Yeah, no, I mean, we've been on a track record of looking at our individual ASP on our disposables, and that ASP has been trending upward. And that's just because we've raised our prices in accordance to market dynamics. But again, we would see that trend to continue. Utilization continues to grow. And I think we are seeing some of the impact of the reimbursement increase that went into PEC January 1. I can't give you an exact number, but directionally, we're heading in the right direction. And again, utilization continues to grow accordingly.
spk09: Okay. Thanks for taking the questions. Thanks, Frank.
spk06: Thank you. Our next question comes from the line of Swayam Pakula Ramakant from HC Wainwright. Please go ahead.
spk09: Thank you.
spk07: Congratulations, Mark. I've been watching you and EDAP for about eight years, and you brought this company to really a place that I'm sure you're very proud of. And congratulations, Ryan, you know, for building up the U.S. operation for the last two years and getting into a place where, you know, you can take off, kind of see tremendous growth from here, at least from my seat. Having said that, Ryan, you know, in terms of what you have been seeing at the ground level in the US and I'm sure there are some learnings from running the operation here. As you move into the worldwide role, how do you see trying to replicate some of the ideas here in other geographies such that you can grow ex-U.S. sales as much as you have been doing in the U.S.?
spk05: Yeah, so when we look at the outside U.S., again, you know, again, you got to look by region and by market. And, you know, each strategy may have some similarities, you know, across regions. But, you know, some markets we may not be distributing products yet or selling those products. specifically Focal One Robotic Haifu, but we're working through a process and a channel to get those approvals. Equally, though, markets are built and driven, and my background at Intuitive, I spent a good part of my career building markets, and a lot goes into that recipe. Activities, of course, being one, but more clinical data, working with women's centers, you know, further developing techniques as you use the technology. I mean, there's a lot of different things that are important here. We are looking at those things very closely, and I think we're seeing some of the benefits in the U.S. I think some of it does, you know, cross-pollinate again into outside U.S. markets. And, you know, I think today you know, as we lead more adoption in the U.S., it will have an influence in outside U.S. markets. It's a validation point. And, you know, just like surgery or robotic surgery emerged as a standard of care for a treatment category of men diagnosed with prostate cancer, I believe focal therapy has a defined role for an appropriate mix of men diagnosed with prostate cancer. So we're, you know, we're applying kind of the general principles strategies that we use in the U.S., and we'll apply more of those strategies now in my expanded role. And I'm really excited to work with these different regions and subsidiaries because I've done a lot of this in my prior career, and I look forward to it. And I think, you know, again, we have great things to do as we build and drive these markets.
spk07: Yeah, thanks for that. um the the last question from me um because most of my questions have been asked earlier um just looking at the high food division um when when we look at the um this the sgns spend uh during 22 which was i believe about 65 higher than the previous year um do you feel the sales force is in in the right place at this point for growth from here onwards in 23 and beyond in the U.S.?
spk05: Yeah, that's a great question. And I think the way to look at it is in prior year 2021, we had a very small, you know, almost non-existent team. And we started building that team out at the end of the year. And that was the very end of 2021. And then walked into year 2022, it with the process of ramping and hiring proven sales executives and hiring those folks and adding them to our team. We've been doing that throughout last year, 2022, and our team is more than doubled, of course, exiting the year. We will expect to nearly double that team again in size by the end of this year, 2023. And part of that is it's an appropriate investment we need to make commercially because we are driving and building a market. And if we're a market leader in focal therapy, we have an opportunity and a lot of real estate to cover. So, again, having a full team of high-caliber executives working together to drive the business is going to be important. I might also add that we have a bifurcated sales force. We have a capital team that drives the capital, but we also have a clinical team that drives the utilization at each hospital that we sell to. So once we install and ramp and train and onboard those accounts, they have a defined role to drive utilization. Combined, our teams work very closely together, but those teams will nearly double this year, exiting 2023. So we're excited. as we build the market and add the capability and resources.
spk07: Fantastic. Thank you very much for taking my questions. And congratulations again, both of you and Ryan.
spk09: Thank you. Thank you. Ladies and gentlemen, if you wish to ask a question, please press star 1.
spk06: Since there are no further questions, I would now hand the conference over to the management for any closing comments.
spk02: Thank you, operator, and thank you, everyone, for attending the call today and for your continued support. And we're looking forward to our next earnings call for the results of Q1 2023. Have a great day.
spk06: Thank you. The conference of EDAP TMS has now concluded. Thank you for your participation. You may now disconnect your lines.
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