This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk01: Welcome to the EDAP TMS first quarter 2021 earnings conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If you would like to ask a question, please press star 1 on your telephone keypad. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jeremy Pfeffer with Investor Relations. Thank you. Please go ahead.
spk05: Thank you, Donna. Good morning and thank you for joining us for the EDAP CMS First Quarter 2021 Financial and Operating Results Conference Call. On today's call, we will hear from Mark Oksakowski, Chief Executive Officer and Chairman of the Board, 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 EDAF's Chairman and Chief Executive Officer, Mark Okcikowski. Mark?
spk07: Thank you, Jeremy, and good morning, everyone. I will start by providing a brief operational update and then turn the call over to François Ditch to review our financial performance. First, let me start by saying that we believe the first quarter of 2021 and subsequent period marks an important point in the growth trajectory of our business. Without question, the successful commercialization of any novel technology must be supported by present and timely investments. In April, we had the opportunity to raise substantial capital that will enable us to fully support our ongoing U.S. focal one commercialization effort, while also advancing a key clinical program in endometriosis. This capital raise was strategically important for several reasons. First and foremost, our strengthened balance sheet now provides us the additional resources to fully engage multiple channels across the U.S. healthcare market. In addition to investing further in market access and reimbursement, which I will discuss in a moment, these additional funds will allow us to attract top tier talent with vast expertise in driving adoption of innovative technologies such as focal one. In addition, we are building out our U.S. clinical marketing and sales organization so that we are well positioned in this most important market. With HIFU gaining broader acceptance as an effective and less invasive paradigm for the management of prostate cancer relative to surgical options, we will firmly establish ourselves as the leader and clearly at the right place at the right time. To that end, we will continue to invest in our U.S. infrastructure. And these activities will be complemented by the many top tier hospitals that have already adopted focal lines that are serving as important reference accounts for our company. Some of these include Mount Sinai, Cleveland Clinic, Ochsner Medical Center, UCSF, and many others, and our pipeline continues to grow, notwithstanding restrictions on some sales and outreach activities resulting from the pandemic. While our strategic marketing efforts will clearly involve engaging leading KOLs, it's equally important that focal one reaches a wide breadth of urology medical practices, And the added resources provided from this funding will help us maximize the opportunity to develop these important relationships. Secondly, our recent financing was also a clear sign of investor confidence that our high food technology represents an important advancement in the management of prostate cancer. As we all know, clinical data generated from well-controlled trials ultimately drives medical decision-making of the time. Without question, the capital we raised during the first quarter clearly reflects a recognition by the investment community that focal one is becoming an important new treatment option for patients battling prostate cancer. Finally, I would also like to add that we truly appreciate the high-quality healthcare-focused investors that participated in this offering. It is gratifying to know that after spending so much time conducting due diligence on our technology and studying the competitive dynamics of our end market, these firms have placed their capital with us based upon a shared vision of bringing an important new innovation to the market. This financing also resulted in expanding research coverage, which we believe will help raise the worryness of our company and the significant unmet need that we are addressing. Of course, launching a new medical technology in the U.S. healthcare market brings several challenges, not least of which is navigating a complex reimbursement third-payer landscape. Changing long-standing medical practices is never easy, and while adding a superior technology, sufficient capital, and a sizable marketing apparatus are all essential elements to a successful product launch. We also recognize that building productive relationships with private insurers and government entities like CMS are critical to establishing focal one as an accepted mainstream procedure. In early March, we announced increased partnerships with two of the leading reimbursement consultancies, MTP and Argenta Advisors. These partnerships are off to a strong start, and we anticipate positive momentum on the reimbursement and market access front across key hospital networks and physician practices throughout the remainder of the year and beyond. Securing attractive reimbursement levels and achieving the broadest possible patient coverage for COVID-19 remain top priorities for our company, and these two strategic partnerships, coupled with the previously announced establishment of a Category 1 TPC code and reimbursement to physicians performing ablation of malignant prostate tissue with HIV in the U.S., will help us drive further adoption and growth across the U.S. From a sales perspective, our combined 401 exact view offering continues to resonate with healthcare institutions as the only end-to-end urology suite available on the market today. Now, I will provide a brief update on our endometriosis program. As noted during our last conference call, this phase two study will enroll a total of 38 women across five major hospitals in France. who will be assessed over a six-month follow-up period. Investigators will evaluate the safety and efficacy of HIFU for this pathology. At the end of April, we opened a second trial site in Angers-France that has already successfully treated two patients. Across both trial sites, we have now treated a total of 19 patients. Enrollment is tracking closely with our internal expectations as we are pleased to be able to execute this study according to our original timeline. We believe the treatment of endometriosis could be greatly improved with application of LACE invasive procedures and the use of HIFU technology could offer an important minimally invasive treatment option for these patients. We look forward to updating you on this important program throughout the year. François will cover the financials in a moment, but let me provide a few highlights from the first quarter. I am happy to report that we generated first quarter total revenue of €10.3 million, or $12.4 million, which represents a strong growth of 35.4% year-over-year and a new Q1 record revenues for the company. We expanded our growth margin to 42.4% and increased our 220 basis points as compared to 40.2% in the first quarter of 2020. Revenue growth and margin extension led us to achieve a profitable quarter for the company, both on the operating and net income basis. Our high school revenues were down slightly versus the fourth quarter of 2020, This was a difficult comparison as we had a particularly strong December, signing key accounts, a few of which we outlined in the press release on December 30th. We also experienced some toughness in high food treatment driven revenues in Q1, particularly in Europe where the pandemic has hit especially hard. However, it is important to note that there is a natural lag between treatment driven revenues and cases performed at hospitals buy kits in bulk and use them over time. In the U.S. particularly, we are pleased by the continued growth in the number of treatments performed in Q1. Most of our key academic centers have increased their high food treatment numbers as compared to Q1 of last year and also sequentially as compared to Q4 of 2020. This is in part driven by the adoption of the Category 1 CPT code since its official implementation in January of 2021, as well as the broadening of wariness of HIFU as an important addition to the Eurology Parliamentarium. Turning to our very strong cash position, we ended the first quarter with cash-in-cash equivalents of EUR 24.4 million or USD 28.6 million, as compared to 24.7 million euros or $30.2 million as of December 31st of 2020. As noted earlier, subsequent to the end of the first quarter, we completed an underwritten public offering of American repository shares that yielded gross proceeds of approximately $28 million. We have a strong balance sheet with which to advance our accelerated growth plan in the U.S. and elsewhere. And now our CFO, Francois Ditch, will provide some details of our financial results. Francois.
spk08: Thank you, Mark, 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 1.1998. for the first quarter of 2021. Total revenue for the first quarter was €10.3 million, an increase of 35.4% versus €7.6 million in Q1 2020, reaching a new record level for the first quarter. Total revenue in the IFU business for the first quarter of 2021 was €1.8 million, a decline of 6.2% compared to 1.9 million euros for the first quarter of 2020. The modest decline is driven primarily to the effect of the COVID pandemic, which continues to adversely impact procedure volumes. Also, we are noticing a positive trend. Total revenue in the listed business for the first quarter of 2021 was 2.9 million euros roughly flat compared to 2.9 million euros for the first quarter of 2020. The total revenue in the distribution business for the first quarter of 2021 was 5.6 million euros, a 102.5% increase compared to 2.8 million euros for the first quarter of 2020, thanks to the exact imaging and laser cell development. Gross profit for the first quarter of 2021 was 4.4 million euros compared to 3.1 million euros for the year-ago period. Gross profit margin and net sales was 42.4% in the first quarter of 2021 compared to 40.2% in the year-ago period. The increase in gross profit year-over-year was due to the higher sales effect and fixed cost. Operating expenses were 4.1 million euros for the first quarter of 2021 compared to 4.5 million euros for the same period in 2020. Operating profit for the first quarter of 2021 was 0.2 million euros compared to an operating loss of 1.5 million euros in the first quarter of 2020. Net income for the first quarter of 2021 was €0.8 million, or €0.03 per BGT share, taking into account the €0.2 million of financial income linked to the U.S. Patriot Protection Program for DNS, as compared to a net loss of €1.2 million, or €0.04 per BGT share, in the year-ago period. We ended the first quarter with cash and cash equivalents of 24.4 million euros or 28.6 million euros as compared to 24.7 million euros or 30.2 million euros at the end of December 2020. Subsequent to the end of the first quarter, we completed an underwriting public offering of American depository shares that yield net proceeds of approximately 25.6 million U.S. dollars. As a result, our pro forma cash currently stands at approximately 54 million U.S. dollars. Our pro forma ADH share count stands at approximately 33.4 million shares including an incentive of 4.15 million IDS, which was transferred to the underwriting offering. And we now turn the call back to Marc. Thank you, François.
spk07: Before turning the call back to the operator to start our question and answer session, I would like to impress upon our investors that we now have in place the essential ingredients necessary for an accelerating commercial rent. a clinical proven technology leading to better patient outcomes, a clear and consistent messaging into our distribution channel, a strengthened balance sheet capable of supporting our future growth, and key strategic partners who are helping us secure attractive reimbursement for 4.1 procedures. Despite continued challenges from the pandemic, 2021 promises to be a year in which our company transforms to treatment of prostate cancer, and longer term, we remain extremely confident in the potential of our high-speed technology to address multiple therapeutic opportunities. We will now open the call to your questions. Operator?
spk01: Thank you. The floor is now open for questions. If you would like to ask a question, please press star 1 on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star two 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. Once again, that is star one to register questions at this time. Our first question is coming from Jason Bednar of Piper Sandler. Please go ahead.
spk06: Hello. I hope everyone's well. My first question, Mark, you mentioned growing demand with HIFU here in the quarter. Has the uptick in utilization continued thus far into the second quarter? And then can you talk about how New Focal One conversations have been going here just the last few months?
spk07: Hey, Jason. Well, thank you. Thank you for joining. Yeah, what I said is that the trend and the number of cases performed in the U.S. during Q1 has shown a significant growth as compared to last year, Q1 as well as Q4. So that's, again, that shows, you know, some momentum in the adoption and in the recruitment of patients, you know, different machines that are, again, that have been bought by academic centers and many KOL sites. I didn't get to the other part of the question, sorry.
spk06: It was just on just how new focal one conversations have been going here just the last few months, basically what the funnel looks like from a demand perspective.
spk07: Yeah. And as I said, I mean, we continue to grow a pipeline of projects. And again, I mean, we continue to get more and more leads in our pipeline. So it's going pretty well. Okay.
spk06: Great. And then maybe a two-part question on the investments that you're planning. are you willing to talk about the pace and sizing of this deployment over the coming quarters? And then understanding you still need to make the investments, can you talk about any time when we should expect to see returns from the investments and account for this in our models?
spk07: Sorry, Jason, maybe the line is not too good, but I didn't get the first part of your question. Can you repeat that?
spk06: Yeah, I was just wondering if you could talk about the pace and sizing, you know, how quick and how much we'll see as far as the investments go, you know, any kind of just guidance or color there for the rest of the year. And then the second part of the question was, you know, kind of similar on the pace and sizing and when the returns might be showing up, whether that's, you know, how much of a lag should we be building in on? I understand this won't come immediately. It should be expecting a you know, three to six-month lag, six to 12-month lag on when these, again, the fruits of the investment start showing up?
spk07: So, well, actually, you know, as I said a few times, and still we are in the beginning of the year, the beginning of the budget cycle, and within the context of the pandemic, still it's difficult to have a very clear visibility on the advancement of the different projects and leads that we have. So it will be difficult for me to clearly answer your first part of the question. Now, for the second part, again, we work on building coverage and market acceptance. And as we discussed several times, this is something that takes a lot of time, though we expect to achieve milestones and increase covered lives at a significant pace And as this grows, definitely the return on investment will start building. So the one is linked to the other. And again, we will put in action, in execution, all of our accelerated plans and actions in order to get into that as quick as possible and therefore generate returns as fast as possible as well.
spk06: Okay. All right. Understood. And then maybe just one last one for me. Mark, you mentioned some key wins on the reimbursement front. Could you expand on what these wins were and maybe, again, expectations on what further progress there might be on the reimbursement front from a coverage standpoint here for the remainder of 21?
spk07: It's all about coverage. Again, as I said, we got the CPT code. implemented at the beginning of the year. Now we need to build coverage. We need to recruit and to get more covered lives. So this is the goal and these are the milestones. So again, the idea is to get as much max for the CMS part as possible, having automatic coverage and positive LCD issues. And on the other hand, the idea is to get private payers starting to get into their policy, the HIFU reimbursement. So this is the plan and these are the metrics.
spk06: All right, understood. Thanks so much. Thank you.
spk01: Thank you. Our next question is coming from Andrew DeSilva of B Reilly. Please go ahead.
spk03: Hey, good morning. Thanks for taking my questions. Just a few quick ones for me to start. Could you start by just letting us know how many focal one allotherm ESWL and XactView systems were placed in the quarter. And while that info is being pulled, I'm just kind of curious why XactView seems to be moving at a much stronger pace than even the HIFU segment. Can you just talk about maybe what's driving that relative to even COCA-1? which has its own reimbursement and is really a very, very complimentary offering, and both have a capital equipment need. So I was just very surprised by the product mix.
spk07: Okay. Hello, Andy. Thanks for the question. So it's a long question, so I may ask you to repeat the second part of the question, but as far as equipment sold, We got six lithotriptos, five XactView machines, and we had no HIFU devices in the first quarter as the same as last year. And the rest of the question was about what?
spk03: Just really trying to understand why XactView is progressing so quickly, even relative to Focal 1, particularly since they're both capital equipment. items and very complimentary to one another. So I've just been very surprised by the overperformance of ExactView, particularly in regard to HIFU.
spk07: Yeah, actually, it's a good question, though. The capital investment is significantly different in purchasing a focal one or an ExactView. It's like more than three times more expensive to buy a focal one. So it's very different. The indication is different as well. I mean, the exact view is used to perform diagnostics of prostate cancer when focal one is for the treatment. So these are two different things. Just to give you an idea in terms of number of equipments or markets, and again, the price is different. It's significantly higher on focal one. They are in the U.S., as I shared on a frequently basis, there are about 1 million biopsies performed every year on prostate. And typically, exactly, you have received that market of diagnostics. When on prostate cancer, newly diagnosed cases, it's about 250,000 cases in the US every year. So it's a different type of market and the volume of equipment solved will be different between an ultrasound diagnostic tool and a surgical minimally invasive equipment tool. Even though, as you said, they are very complementary, but usually you have much more diagnostic equipment in the field than treating equipment.
spk03: That makes sense. And as it relates to ablotherm versus focal one, is there a strategy with that system? And the reason I ask is I noticed that last or during the fourth quarter, you actually placed a couple systems. So I wasn't sure if we should be thinking about ablotherm in any sort of material way going forward or if those are more one-off situations.
spk07: Yeah, no, that's more punctual and... important thing as well is that we don't manufacture ablisem anymore and the ablisem machine we sold are usually secondhand or refurbished equipment and in the case of the equipment we sold at the end of last year that were secondhand machine you know we did in the past some trading program for our ablisem users in the us to upgrade to a focal one so they were buying a focal one and we were traded in the ablisem so for those that want to invest little money in getting into HIFU, those second-hand labor firms are a good opportunity. So it's really a punctual and opportunistic business.
spk03: Okay. Okay, perfect. And last quarter, you referenced your partnership with MTP and Argenta. I was just curious how things were progressing with commercial reimbursement, and maybe let us know – you know, what initiatives we should be looking for next out of those partnerships?
spk07: Yes, we started and actually we started, we announced the increased partnership with those companies last time, but we started to work with them before. That's how we got, you know, the C code and then the CPT code. That's a long relationship that we've had. We increased the relationship now because we want to focus on coverage. And most of the initiatives is to really get started on speaking with private payers. And we actually already started to do some meeting with the medical directors of private insurances. So we work on that. We also built our hotline to give support to our existing users so that they can claim the right way and properly with our support their cases and get this claim done and covered. So it's all about this kind of initiative. And as I said, as well, as we now have completed the financing, we will increase further the action plan in helping our sites, in lobbying the payers, and in building more coverage with those partners, but also with the key people that we're going to get into our team.
spk03: Okay. But nothing... should really materially deviate beyond what we previously talked about as far as the commercial coefficient multiplier being, you know, one and a half to three times higher than that of Medicare, correct?
spk07: Yeah, we're not there yet, but that's ultimately when they decide to cover, they will use their usual multiples that can be variable from one to the other.
spk03: Okay. And last question. Just kind of getting a little more granular on what kind of investments we should be expecting from a U.S. commercialization standpoint now that you've got the recent capital infusion. Could you maybe just discuss where you are today with your sales force and supportive reps that are focused on U.S. sales and maybe where you hope to be by the end of the year from a sales rep standpoint? And then if someone could just talk around what we should kind of think about OpEx looking like for the year, that would be helpful. Obviously, the first quarter was very well managed, particularly relative to the fourth quarter of last year. So any guidance or assistance there would be very useful. Thank you very much.
spk07: Yeah. Thanks for the question. I don't have yet the weight and the name of the guys, but we're talking with a number of people. And again, the idea, like I said today, and I said that before as well, we really want to build and increase the company. We really want to bring and strengthen our clinical marketing and sales team. It's not only about sales people. It's also about, again, helping building the coverage by more marketing initiatives, by more clinical initiatives gathering the clinical data from our top-tier academic centers that are already using the technology. So we will definitely, before the end of the year, grow significantly the company. And again, not only in the sales force, but will increase, but also in the marketing and clinical departments so that we have more actions and initiatives on that side as well.
spk03: Okay, but just say today, do you expect it to be like two or three times bigger as far as the size of the sales force and marketing team and clinical teams domestically in aggregate?
spk07: Yeah, that will be, again, as much as possible. Now we have all the ingredients, like I said, to move forward and deliver and execute. Now, it's all a question as well of opportunity. And again, the idea is not just to double or triple the sales force. The idea is to get the best guys. So I don't want to double my sales force with people that will not sell. I want to get the best salespeople, and that's what we are building. So we're looking for speed, but we're also looking for quality. So the idea is a good compromise. And again, that's the difference between theoretical. So I can tell you we're going to double it in theory. But if I can triple it because I find the right guys, I will do. If I can just increase by 50% because I only find the right guys, 50% of increase, that's what I will do. So it's a compromise that's realized. It's a compromise between quality and speed. And again, our idea is to go the fastest way possible with the best quality of people and partners involved in our program so that we can achieve it successfully as quick as possible.
spk03: A very good point. Thank you very much. Best of luck. Thanks, Andy. Really looking forward to watching progress. Thank you.
spk01: Thank you. Our next question is coming from Frank Takanan of Lake Street Capital Markets. Please go ahead.
spk04: Hey, thanks for taking the questions. Wanted to start with ExactView. Mark, could you update us on, roughly speaking, overlap of sites with both exact view and focal one. And then I wanted to kind of target the sites that do have an exact view installed, and how you view that opportunity to sell focal one into?
spk07: Yeah, that's a good question. And again, the complement between the two technologies and devices is is evident in the synergies as well. Again, as one is very dedicated to precisely and on a targeted way diagnose where prostate cancer is in the prostate. So that's the exact view. And then once you have that level of capability of diagnosing prostate cancer, then you want certainly to do some targeted and focal treatment. And that's where focal one fits perfectly exact view. So again, that's really the... the way it has a good complement, and that's really the way they work perfectly together. On the second part of your question, it is true that the pipeline of projects or the install base of ExactDuty, which is about 100 systems around the world now, certainly for those that don't have a focal one yet, the logical next step when you're able to do targeted diagnostic is to be able to do focal treatment or targeted treatment. So these are extremely good candidates to initiate a FOCAL-1 project. So that's, I mean, indeed all those existing executive users are extremely good candidates and targets for building projects in FOCAL-1 and generating sales.
spk04: Perfect. Thank you. And then next on endometriosis, I think this is kind of a little bit of a hidden gem here, given all the attention given to HIFU for prostate cancer. Could you just update us? I heard the comments about the new site and we're only a couple of patients, but could you just update us on expected milestones over the next 12 to 24 months? And then if I remember correctly, I believe the focal one is already the regulatory landscape for focal one already has endometriosis in place. So you don't have to go through another regulatory process. Rather, it's more about generating data to support the use of the system and indication. Am I thinking about that correctly? Not really. Not exactly.
spk07: Focal one is approved for prostate, for prostate tissue elation or prostate cancer treatment, depending on where you are in the world. But the device is the exact same in the investigation for the endometriosis program. Now, the study that we're doing, the phase two study and probably a phase three study that we'll conduct after this one, will be a key in the regulatory path towards C-marking and then FDA clearance. So it's not yet approved or cleared, for endometriosis treatment. As far as the milestones, and the regulatory aspect is one of the milestones, ultimately, the milestones are to conclude recruitment on the phase two study within the year. And hopefully that will be also based on how the pandemic will impact on us. But so far we're doing very well. As I said, already half of the treatment. We've done 19 out of 38, and that goes pretty well. We opened the second site. We will soon open other sites. As a reminder, we have five centers that are involved in the nucleocentric study phase two. So the idea is to, within this year, to conclude the recruitment and treatment of patients. Then we have a follow-up of six months, so that gives you an idea of the next milestone, which is the end of the study. And then based on that, The idea would be to discuss with healthcare authorities to see if the data gathered during the phase two studies are enough to get into a regulatory discussion, or shall we need to get started on the phase three, which will start in any case, just like you said, to get some clinical data. So this is a little bit the program and the different milestones in front of us.
spk04: Got it. That makes sense. And last one for me, given the higher mix of distribution in the quarter and the expectation of HIFU trending back up through the end of the year, is it safe to assume we should expect gross margins to trend upward through the end of fiscal year 21?
spk07: Yeah, it's a good assumption looking at it this way. And as you know, HIFU contributes very positively to increasing the gross margins. So, That's what we see.
spk04: Perfect. Thanks for taking all my questions. Thanks, Frank.
spk01: Thank you. Our next question is coming from Swayam Pakula, Ramakant of HC Wainwright. Please go ahead.
spk02: Thank you. This is RK. Good afternoon, Mark. Hello, RK. All right. Ablatum and Focal-1 have been with some of the tier one organizations for quite a long time. You know, some of them probably starting from when you had the clinical program going on with some of these folks. At this point, you know, do you think that you have exhausted all the leads within the tier one institutions and what learnings have you gotten from the experience from these folks that you can take to the next level now that you have the CPT code? Probably the discussions are a little bit easier to get to the tier two institutions.
spk07: Well, thank you, Ake, for the question. No, we have not yet covered all the tier one institutions. As we discussed several times, There are 5,000 hospitals in the U.S., and about 1,500 to 1,700 of them are having a urology department dealing with prostate. The Tier 1 hospitals are about 10% of those, so it's about 150 to 170 hospitals in the country that are considered academic centers or reference centers for the management of prostate cancer. As you know, we have about 15 focal ones, and we had a few additional other terms. So we're far from... from saturating the Tier 1, and we have a lot of potential in front of us. And most of our current leads in the pipeline that, as I said, is continuing to increase, are within that category of Tier 1 hospitals. So we still have a lot to extend in there. And again, the more covered lives we have, the easier it will be to convert those leads into cells. And as you say, ultimately, we expand further the coverage and the adoption of the technology, then we start including tier two hospitals. So we still have a long way and great potential in front of us.
spk02: Great, great. And as you stated, you know, it looks like the coverage is becoming the key now, you know, in terms of trying to increase adoption. So towards that end, obviously, you have picked up, you have been working with these consultancies for a while now. So in the road to getting complete reimbursement or more of the reimbursement wins, what are the potential next steps now that you have the CPD code And also just trying to figure out, does that help you to help some of these centers to increase the procedure rate? And because last time we were talking, some of these folks were still trying to figure out how to use the code and how to get through the paperwork. How far are they into that? And, you know, just highlight to us a little bit about what are the ways that you as an organization are trying to help these folks increase their procedure volume now.
spk07: So, basically, that's a little bit what I said before today. First, we need to, the next steps are getting more COVID lights, and that's through getting LCDs from the MACs on CMS Medicare patient side, and that's by getting more and more private insurance, including HIFU in their policies. So these are the next milestones to recruit these payers and have them covering the technology on another automatic basis. What we are doing, and like you said, when you have a new technology, when you have a new code, it's always a challenge and always need help supporting education, even on big reference centers to have them clean properly. And that's what I just explained a few minutes ago, in explaining some of the actions that we are now putting on place and increasing intensive support. And that's part of it is the hotline that we've created to support all of our users in getting their claim done the proper way and the fast way so that they can get coverage, they can get reimbursement. So these are all the initiatives. And again, that's part of what I said before. Now that we have concluded that financing, we will increase further, you know, the clinical marketing and sales initiatives so that we will generate more leads, more sales, but we will also help our users and current and future to increase the number of treatments and number of procedures performed on our equipment. It's all about It's all about volume here.
spk02: Thanks. Thanks for taking my questions. Thank you, Ake.
spk01: Thank you. At this time, I would like to turn the floor back over to management for any additional or closing comments.
spk07: Thank you, operator, and thank you, everyone, for joining us today. We will update you on all of our programs and initiatives as we move forward, and we'll be happy to have you on the call for the second quarter. earning calls in summer. Thank you very much.
Disclaimer