Ladies and gentlemen, 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. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, John Fraunces, Managing Director of Life Advisors. Please go ahead.

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 Marc Oczachowski, Chief Executive Officer and Chairman of the Board; Ryan Rhodes, Chief Executive Officer of EWS; 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, Marc Oczachowski. Marc?

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 Dietsch, 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 or $16.2 million for the year. And we announced record revenue of €55.1 million or $58 million, 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 continued to execute by expanding the number of medical centers that are now using our therapeutic ultrasound solutions Focal One Robotic Focal HIFU. As the global leader in therapeutics HIFU, EDAP enjoys a significant technology advantage in the marketplace. And we continued strong market execution, we anticipate momentum in the form of increased in placements and utilization will continue throughout 2023. Our Distribution segment also performed very well during the fourth quarter. We sold 11 ExactVu units during the quarter as compared to nine in the fourth quarter of 2021. This is concluding a strong year for the ExactVu 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 therapeutics HIFU beyond prostate cancer. In January, we announced positive clinical results from…

Thank you, Marc. I first want to say thank you to both Marc and all the EDAP Board members for their confidence 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 market. 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 One 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 increased reimbursement of approximately 90% to, on average, $8,558 per procedure. This appropriate increase in reimbursement officially went into effect on January 1, 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…

Thank you, Ryan, and good morning, everyone. And please note that all figures, except for percentages are in euros. For conversion purposes, our average euro-dollar exchange rate was 1.02 for the fourth quarter of 2022. Total revenue for the fourth quarter of 2022 was €15.7 million, a 12.5% increase as compared to total revenue of €40 million in Q4 2021. Looking at revenue by division. Total revenue in the HIFU business for the fourth quarter of 2022 was €5.4 million as compared to €4.2 million for the fourth quarter of 2021, an increase of nearly 28%. We sold seven Focal One units in the fourth quarter of 2022 versus five in the fourth quarter of 2021. Total revenue in the LITHO business for the fourth quarter of 2022 was €3.6 million as compared to €3.3 million for the first quarter of 2021, a 7.5% increase year-over-year. We sold 11 lithotripsy devices during the first quarter of 2022 versus nine in the year ago period. Total revenue in the Distribution business for the fourth quarter of 2022 was €6.7 million compared to €6.4 million for the first quarter of 2021. The 5% increase was primarily driven by 11 ExactVu sold during the first quarter of 2022 as compared to nine units sold during the first quarter of 2021. Gross profit for the first quarter of 2022 was €7.2 million compared to €6.2 million for the year-ago period. Gross profit margin and net sales was 45.9% in the fourth 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 and fixed costs and the development of the HIFU division, which has better margins. Operating expenses were €8.9 million for the fourth quarter of 2022 compared to €5.8 million for the same period in 2021. The increase was primary 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 compared to an operating income of €0.5 million in the first quarter of 2021. Excluding the impact of the non-cash share-based compensation, operating loss for Q4 2022 would have been €0.8 million compared to an operating income of €1.2 million in Q4 2021. Net loss for the fourth quarter of 2022 was €5.1 million or €0.15 of per diluted share as compared to a net income of €1.4 million or €0.04 of per diluted share in the year-ago period. As of December 31, 2022, the Company had cash and cash equivalent of €63.1 million or $67.5 million compared to €47.2 million or $53.4 million as of December 23, 2021. I will now turn the call back to Marc.

Thank you, Francois. In summary, our strong fourth quarter results reflect increasing demand for our leading therapeutic HIFU solution, which addresses early intermittent state 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. Operator?

Ladies and gentlemen, at this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Michael Sarcone from Jefferies. Please go ahead.

First, I'd say, Marc, congrats on many years of successful execution, and Ryan, congrats on the new role.

Great. Thank you.

You're welcome. I guess just to start, for Ryan, 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 what you will reinforce versus where you might change course?

Yes. I think from the strategy standpoint, obviously, 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, our distribution business continues to perform well for us. And I'm excited when I look at our micro ultrasound product, ExactVu, 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.

Got it. Okay. And just one on the sales funnel in the U.S., can you talk about how that's shaping up so far? You noticed you mentioned customers continue to indicate strong interest. I was just curious if you could elaborate a little more on that, the different types of accounts, maybe the size of those customers expressing interest and how you're thinking about system placements in 2023?

Yes. 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've worked 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.

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.

Yes. 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, with the pro forma analysis done correctly, adding Focal One Robotic HIFU, they can show an immediate return on 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 new incremental patients to that individual hospital catchment market and paid 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 analyses, but we have not seen anything particular in terms of a broad hesitation to purchase disruptive capital equipment.

Thank you. Our next question comes from the line of Joseph [indiscernible] from Piper Sandler.

I'm on for Jason today. Congrats, Ryan, on the transition. First, starting with guidance, I know you guys didn't perform 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?

Yes. I don't think we've provided any guidance. I think, again, we're looking -- 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 we're following the playbook and road map that we've established for the U.S. Maybe -- I don't think anything is changing abnormally in -- outside U.S. market.

Yes, absolutely, yes.

Great. 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 you 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 in each Focal One unit that might be sold in a given quarter?

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 One and HIFU activity, 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 revenue that has helped to increase the gross margin. So that will certainly continue the trend as we continue to grow the business of HIFU worldwide.

Understood. Just one more from us. On the commercial reimbursement side, what's the reasonable time line 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?

So, we do have commercial payers today paying for HIFU treatments. We track that and work closely with our customers and the payers. Currently, 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 that kind of momentum in their language change is very helpful. But I think looking outward, we will continue to see 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 time frame, but we have a road map 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.

Thank you. Our next question comes from the line of Frank Takkinen from Lake Street Capital Markets. Please go ahead.

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 in 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?

Yes. So Frank, usually, Q4 obviously is a strong quarter for most companies, inclusive of us. So we finished 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 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.

Got it. Okay. That's good color. And then secondly, 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 in some -- to some extent throughout the call today, but I 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 of weeks ago and how that could influence those guideline decisions and conversations?

Yes. So again, we see more data coming out, and I'll talk about that being the HIFU study, which was published study that has been under the authorization of Professor [Rishman] 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're excited because we think those studies are performed with high discipline, and we'd expect those results to continue to be reproducible out in the markets. So, in terms of guideline development, we have a notable installed base of leading cancer centers. And so, one of our missions is to work closely with them and see where they can possibly through the data that they're tracking, we will 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 and the 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.

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 expected ASP changes specifically within the consumable piece of the sale.

Yes. So since going back to the -- can you repeat that question again?

Just the utilization trends of what the systems are. Yes and if they're -- 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 disposable.

Yes. 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 upwards, 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 in effect 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.

Thank you. Our next question comes from the line of Swayampakula Ramakanth from H.C. Wainright. Please go ahead.

Congratulations, Marc. I've been watching you and EDAP for about eight years, and you brought this company to really place that I'm sure you are very proud of. And congratulations to Ryan for building up the U.S. operation for the last two years and getting into a place where you can kind of see tremendous growth from here, at least from my seat. Having said that, Ryan, in terms of what you have been seeing at the ground level in the U.S., 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 as such that you can grow ex-U.S. sales as much has been doing in the U.S.

Yes. So when we look at the outside U.S., again, again, you got to look by region and by market. And each strategy may have some similarities across regions. But some markets, we may not be distributing products yet or selling those products, specifically Focal One Robotic HIFU, but we're working through a process in 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 the new centers, 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 cross-pollinate again into outside U.S. markets. And I think today, as we lead more adoption in the U.S., it will have an influence about markets. It's a validation point. And 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 applying kind of the general 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, again, we have great things to do as we build and drive these markets.

Yes. The last question for me because most of my questions have been asked earlier, just looking at the HIFU division, when we look at the SG&A spend during '22, which was, I believe, about 65% higher than the previous year. Do you feel the sales force is in the right place at this point for growth from here onwards in '23 and beyond in the U.S.

Yes, that's a great question. And I think the way to look at it is, in prior year 2021, we had a very small, almost non-existing team. And we started building that team out at the end of the year the very end of 2021 and then walked into your 2022 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 has more than doubled the 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 the market. And we need -- 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 worked 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.

Thank you. [Operator Instructions] Since there are no further questions, I would now hand the conference over to the management for any closing comments.

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.

Thank you. The conference of EDAP TMS has now concluded. Thank you for your participation. You may now disconnect your lines.