Greetings. And welcome to the EDAP TMS First Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now pleasure to introduce your host, John Fraunces, from LifeSci Advisors. Thank you, you may begin.

Good morning and thank you for joining us for the EDAP TMS's first quarter 2022 financial and operating results conference call. On today's call, we will hear from Marc Oczachowski, 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'd 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 a brief and personal updates before turning the call over to Ryan Rhodes, our EDAP US Chief Executive Officer for a review of the US business strategy, and then Francois Dietsch, our CFO will present a financial performance. I will start by recapping a few of the highlights. For the quarter, we generated total revenue of EUR 13 million or $14.5 million, representing an increase of 26% as compared to EUR 10.3 million or $12.4 million in the first quarter of 2021. The increase was driven by a very strong capital quarter, particularly in the US. We sold four Focal One Robotic HIFU units during Q1 of 2022 as compared to zero in the year ago period. Three of those sales occurred in the US and one was o-US. We also sold nine ExactVu units as compared to five in the year ago period. By any measure, the first quarter was a very strong start to the year due to the investments we've made in our US team and infrastructure last year. I'm excited about the opportunity in front of us in ‘22 and beyond. At this point, I would also like to provide an update on our expansion activities where we believe HIFU and our clinical utility in indications outside of prostate cancer. As a reminder, we are running a Phase II study evaluating HIFU using the Focal One Robotic platform for the treatment of deep infiltrating endometriosis. We announced on our last quarterly update that we completed enrollment and patients treatments. So we are in the six month follow up period that will likely conclude at the end of September of this year. Investigators are evaluating the safety and efficacy of HIFU for this technology. As we said before, we believe that treatment of endometriosis may be greatly improved, and the use of HIFU technology could offer an important minimally invasive treatment option for these patients. The alternative for these patients is often an extensive surgical removal of the bowel. We look forward to results from this important study at HIFU could really add significant value in the management of complex endometriosis, for which there are no currently effective, minimally invasive options. With over $51 million of cash, we are well financed to continue to execute our US growth and expansion plans while in parallel exploring these and other clinical expansion opportunities. At this point, I would like to turn the call over to Ryan Rhodes, CEO of EDAP US for an update on our US operations. Ryan?

Thank you, Marc. As we pre announced on April 12th, the first quarter 2022 was very successful for us in terms of additional Focal One, and ExactVu placements in the US. As stated we sold three Focal One machines. Notably all three sales occurred at prestigious academic and integrated health network reference centers to include New York-Presbyterian/Weill Cornell Medical Center, Beth Israel Deaconess Lahey Health, an affiliate of Harvard Medical School, and University of California Davis Medical Center in Sacramento. University California Davis represents a company's fourth placement within the University of California Health System. Following earlier placements at UC San Francisco, UC Irvine, and UC San Diego. These results are a result of our progress in further penetrating both groups of very large and very prestigious Network Hospitals. In addition, we announced the sale of five ExactVu micro ultrasound systems in the US during this quarter. Taking together this was a record quarter for capital equipment sales for the company, and reflects the tireless work of the world class team that we have assembled in the US. Another strong leading indicator, of course, is our sales pipeline. Not only does it continue to grow in terms of absolute dollar value, but more and more of it is comprised by community hospitals, in addition to academic medical centers. This is not surprising, as the vast majority of hospitals in the US are community hospitals, but it is also indicative of the growing acceptance of focal therapy as a leading treatment options within urology suite and hospitals of all sizes. Just a few days ago, we had a notable presence at the Annual Meeting of the American Neurological Association or AUA, which is the largest annual gathering of neurologists worldwide. We exhibited and showcased Focal One, and it was a feature…

Thank you, Ryan. And good morning, everyone. Please note that our figures except for percentages are in euros. For conversion purposes or otherwise US dollar exchange rate was 1.1177 for the first quarter of 2022. Total revenue for the first quarter of 2022 was EUR 13 million, the 26% increase as compared to a total revenue of EUR 10.3 million in Q1 2021 when reaching a new wakeup level for our first quarter. Looking at revenue by division, total revenue in the HIFU business for the first quarter of 2022 was EUR 3.8 million as compared to EUR 1.8 million for the first quarter of 2021, it represents a 112% increase. We should first look at when you need in the first quarter of 2022 versus zero in the first quarter of 2021. The total revenue in the LITHO business for Q1 2022 was EUR 2.2 million as compared to EUR 2.9 million for the first quarter of 2021. We sold one lithotripsy device during the first quarter of 2022 versus six in the year ago period. Total revenue in the Distribution business for the first quarter of 2022 was EUR 7 million as compared to EUR 5.6 million in Q1 2021. This is a 24% increase was primarily driven by nine ExactVu units sold during the first quarter of 2022 as compared to five units sold during the first quarter of 2021. Gross profit for Q1 2022 was EUR 5.8 million compared to EUR 4.4 million for the year ago period. Gross profit margin on net sales was 44.3% in the first quarter of 2022 compared to 42.4% in a year ago period. The increase in gross profit margin and net sale was primarily due to the higher sales effects on fixed cost. Operating expenses were EUR 5.9 million for the first quarter of ‘2022 compared to EUR 4.1 million for the same period in 2021. The increase was driven by the ongoing build out of US team and commercial infrastructure and included EUR 0.6 million of non-cash impact related to share-based compensation programs. Operating loss for the first quarter of 2022 was EUR 0.1 million compared to an operating profit of EUR 0.2 million in Q1 2021. Excluding the impact of non-cash share-based compensation programs operating profit for Q1 2022 would have been EUR 2.5 million compared to an operating profit of EUR 0.3 million in Q1 2021. Net income for the first quarter of 2022 was EUR 0.4 million or EUR 0.01 per diluted share, as compared to a net income of EUR 0.8 million or EUR 0.03 per diluted share in the year ago period. As of March 31, 2022, the company held cash and cash equivalent of EUR 46.4 million or US $51.6 million as compared to EUR 47.2 million or US $53.4 million as of December 31, 2021. And I will now turn the call back Marc.

Thank you, Francois. In summary, we are very pleased with our performance in the first quarter. And I believe this sets up for a very successful year. Both US capital placements and treatment volumes continue to reflect the thoughts of Ryan and his team. And I believe they are just scratching the surface in what is clearly our most important market and opportunity. I look forward to our next quarterly update in August. We will now open the call to your questions. Operator?

[Operator Instructions] Our first question comes from Frank Takkinen with Lake Street Capital.

Great. Marc, Ryan, Francois. Congrats on the results. Couple for me today. I wanted to start with some comments around the funnel. Appreciate the update there and the call out for the mix of community hospitals in there. So maybe a two parter. Maybe could you speak to the growth in the dollar value of the funnel versus maybe last quarter and last year? And then two, how has that mix on a dollar value basis shifted between community and academics over the last year?

Yes, so we've got a very strong pipeline. I think we've referenced out on this call, and we continue to add new centers into that pipeline, I would say, coming after AUA, which was a great event for the company, we continue to see added interest both from the academic centers and community hospitals. So I still think you'll see a lot of movement on the academic side, because they have a strong anchor in treating prostate cancer patients. They also have some of the more robust programs in terms of providing active surveillance as an option for men diagnosed with prostate cancer. And this fits very nicely into the treatment pathway for many of these patients. So I would say just looking backward we're going to see more activity in the community hospitals. Our pipeline is made up of both academic centers, Regional Cancer Centers, and of course, community hospitals. So I think as we look outward, obviously, more activity in community hospitals over time, but I think we have an equal mix of both academic and community.

Okay, that's helpful, and then maybe talking to regular or irregular seasonality of the business. If I remember correctly, I think Q1 is normally the weakest for all business lines, but obviously Q1 was nowhere near weak, this year. So I was just curious if you could comment on any seasonality expectations for 2022. Do you expect Q1 to carry its regular cadence of being the lightest quarter normally, of the year with Qs, 2, 3 and 4, the rolling off of the baseline set with Q1?

Well, in our business historically speaking for that, in ourselves, Q1 is not the weakest, Q3 usually where it slows down before getting back to very, to a lot of activities in Q4. So we take Q1, Q2 are usually kind of equal than Q3 is a little bit low and Q4 is strongest. That's the seasonality. And we'll see. And again, as we're ramping up and as we are growing significantly, as you could see, and here today, our US business, this may affect a little bit as well, the seasonality as usual.

Okay, and then maybe just last one for me. I know this was talked about on the last earnings call. That wasn't that long ago. But any update on CMS conversations? I think we're waiting for a preliminary read in July, which would set the stage for a final read or decision in around the fall time on whether or not you'll be upgraded to APC level 6, I think there was some data review going on too. So any comments you could provide on there or any update on your latest thinking around AP 6, APC level 6 eligibility?

Yes, so as mentioned before, we had a call with CMS back in mid middle of February. And it was a good discussion. One of the things we were probing at is to understand if they would be looking at the 2021 data to factor in their proposed rule. With that said, we never got confirmation from them. However, if you look at the inpatient proposed rule that was awarded, the inpatient proposed rule was based on 2021 data. And why I referenced this is the 2021 data shows an increase in procedures and an increase in hospital reported cost, which puts us closer to the payment of APC 6 versus where we're at today at APC 5. So again, I remain guarded optimistic, and we'll know in July with the proposal coming out where we stand. We've done everything on our side to work efficiently and effectively with CMS. And we'll have to sit tight and be patient to see what may play out. I will also highlight and very important, we continue to sell in place systems today based on the reimbursement that is current in the market. We have full reimbursement today. In the CPT code. We have a facility payment, we have a professional fee payment. And as noted here, we are selling and placing systems with the current reimbursement. But we will see what happens in July.

Our next question is from Jason Bednar with Piper Sandler.

Hey, good morning. Thanks taking the questions. This is Joe on for Jason, and congrats on a nice start to the year here. Yes, on OpEx side, spending level trails, and we were expecting that again in the first quarter. And you're clearly demonstrating strong commercial progress, even without taking OpEx even higher than you have, in your current commentaries that measured investments will continue to be made. But what's the right way we should be calibrating ourselves and thinking about the growth of OpEx in the context of top line growth, that's running out of 15% to 20% plus rate, thanks.

As commented, by Francois, during the call today, we increase our operating expenses, as again, we're building the company here in the US. And again, that's an ongoing process. So as we get on board, more people, more salespeople, more marketing, and clinical people here in the US, will definitely increase the OpEx. And that will be seen in our P&L in the next quarters. So that's again, that's -- we are in moving situation. We're not just adding a few people last year, I mean, Ryan has brought on board a number of talented world class people during the first quarter and they came. No, they don't all came, they didn't all came at the same time. And we are continuing here to hire, again, first and best people to help developing broader markets in the US so that we continue to increase.

Great, thanks. It's really helpful. And then one more from us. Yes, on the balance sheet, I did want to ask it looks like your inventory levels move lower than what we've seen over the past couple of years. Was this a purposeful drawdown as your management, you're managing working capital more efficiently? Was there any timing element at play here? Or is this at all a function of supply chain or sourcing headwinds eating into some of the safety stock you might normally carry? Thanks.

Well, no, I mean, nothing much to say there. I mean, we're as usual diligently work on our supply, manufacturing and inventory. So we're trying to be as effective as possible.

Our next question comes from Swayampakula Ramakanth with HC Wainright.

Thank you. This is RK from HC Wainright. Good morning, Marc, Ryan and Francois. Congratulations on great start for ‘22. So Marc, and Focal One has been in the US market for about four years now almost to the date. So during this time, and obviously, tremendous work has been put in into commercialization of Focal One. Can you comment on the timing, the time it is taking these days from a lead to a final purchase? How has that time been trending? Is it getting better by the quarter? Just want to get a feel for things. So that we can have an idea about the trajectory of placements from here onwards.

Yes, RK, so I’ll answer that. There we see the time from interest to time of closing the deal. It can span several months or longer. I think what's really been impactful is obviously having a built out sales team on the capital side. So our regional business directors now we've got a well, that team by a notable vice president Scott Finger, and we've got that team, now trained up active in their accounts covering their geographies. So, again, there's always nuances in terms of sales cycle times. And I can't even give you an average. But I will say that there are some hospital systems that see the strategic value of focal therapy in the treatment of prostate cancer. And, as mentioned, we are best-in-class technology. So when hospitals are looking at adding focal therapy strategically, and they recognize the clinical value, and even the economic value, if we get in front of the right people, those cycles, sales cycle times come down in terms of duration. So I would say that over time, I would, it would be fair to say that the cycle times would become shorter. But if you look at the law of averages, some deals take longer, some can move very quickly. Sometimes the community hospitals will move very fast. Because they're used to buying, just disruptive medical equipment, and they understand the strategic value. So I think as we build out more of a mix, the cycle times will come down. But we are a premium price product, we have best-in-class technology. And I think when customers look at us as a company and look at our product, they want our product. And a good gauge of that was the interest that we had just here this past week at AUA. So we're very excited as we look throughout the rest of 2022 and beyond. And we'll continue to focus heavily on our commercial growth strategy.

Fantastic, thank you very much, Ryan, for that. And then on the, any commentary, you can provide on the procedure volume, just to get a flavor for the utility of the unit over the last year, year and half because coming out of COVID, has the number of cases been increasing. Same, just trying to understand how that's working out for you, folks. Obviously, that impacts other pieces within the revenue lines.

Yes. RK. So we continue to see growth, sequential growth, and quarter-over-quarter double digit growth. And we would continue to obviously see more centers coming online. We're training more doctors today, as we place more systems, but we're also training additional doctors at current install sites. And I think that's a good sign, meaning more are interested in using technology, and have identified a subset of patients who are ideal candidates for focal therapy. So again, as mentioned, we continue to see sequential growth, double digit growth quarter-over-quarter.

Perfect. The last question for me is for the long term, utility of the platform. So Marc, you kind of gave a teaser out there saying that you're looking at other indications outside of endometriosis? Is it too early for you to comment on what such indications could be? Or if you could give something now?

No, actually, and we discussed that on the last quarterly conference call. We also working on expanding into BPH treatment, as I said last time we did the two first patients in Lyon, two months ago, and we also are exploring, working on pancreatic cancer, as we said, but it's on a very early stage. And you've all studied so far. So we're engaging in various other indications, again, to get to a full multi-application robotic HIFU platform on the long term as the vision of the company.

And then on the endometriosis itself. As you said you would be able to get some data late this year. So just a smaller Phase II study at this point. How soon can you transfer from there into a larger study? And is there any way you can talk about how large of a study you could be doing in the endometriosis indication itself?

Yes, I mean as I said earlier today, I mean, we will be at the end of the third period in September. So we might be able to get some analysis and data disclosed by the end of the year on that study. And as we said, as well in the past, we will continue to build clinical studies and potentially a Phase 3 study. We'll get started in the next month to come. So we continue to move into clinical evidence and building the clinical evidence of that indication with HIFU.

Thank you. There are no further questions at this time. I would like to turn the floor back over to Marc Oczachowski for any closing comments.

Okay, well, that concludes our call this morning. Thank you again for your interest in EDAP and have all a good day.

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