Edap Tms S.a. (EDAP) Q1 2021 Earnings Report, Transcript and Summary

Greetings and welcome to the EDAP TMS First Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jeremy Feffer with Investor Relations. Thank you. Please go ahead.

Thank you, Donna. Good morning and thank you for joining us for the EDAP TMS first quarter 2021 financial and operating results conference call. On today's call, we will hear from Marc Oczachowski, 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 the 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, Jeremy. And good morning, everyone. I will start by providing a brief operational update, and then turn the call over to Francois Dietsch 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 a question, the successful commercialization of any novel technology must be supported by prudent and timely investment. In April, we had the opportunity to raise substantial capital that will enable us to fully support our ongoing US Focal One commercialization effort, while also advancing the key clinical program in endometriosis. This capital raise was strategically important for several reasons. First and foremost, our strengthened by balance sheet now provide us the additional resources to fully engage multiple channel across the US 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 US 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 sensitive paradigm for the management of prostate cancer relative to surgical option, 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 US infrastructure. And these activities will be complemented by the many top tier hospitals that have already adopted Focal One 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 KOL, 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 HIFU technology represents an important advancement in the management of prostate cancer. As we all know, clinical data generated from well controlled trials ultimately drive 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 settling 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 final thing also resulted in extending research coverage which we believe will help raise the worthiness of our company and the significant unmet need that we are addressing. Of course, launching the new medical technology in the US healthcare market brings several challenges, not least of which is navigating the complex reimbursement, third payer landscape. Changing the long funding medical practices is never easy, and while adding the superior technology, sufficient capital and a sizeable marketing authorities 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 2 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 network and finishing practices throughout the remainder of the year and beyond. Securing effective reimbursement level and achieving the broadest possible patient coverage for Focal One remain top priorities for our company. And these two strategic partnerships, coupled with the previously announced establishment of the Category 1 CPT code and reimbursement to physicians performing ablation of malignant prostate tissue with HIFU in the US, will help us drive further adoption and growth across the US. From a sales perspective, our combined Focal One executive offering continues to resonate with healthcare institutions, as the only end-to-end urology suites 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 2 study will enroll a total of 38 women across 5 major hospitals in France who will be assessed over a 6 months follow-up period. Investigators will evaluate the safety and efficacy of HIFU pathology. At the end of April, we opened a second trial site, sorry, [indiscernible] that has already successfully treated 2 patients across both trial sites. We have now treated a total of 19 patients. Enrollment is tracking closely with our internal expectation 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 placing basic processes, 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. Francois 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 EUR 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 gross margin to 42.4%, an increase of 220 basis points as compared to 40.2% in the first quarter of 2020. The revenue growth and margin expansion led us to achieve a profitable quarter for the company, both on the operating and net income basis. Our HIFU 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 a softness in HIFU treatment driven revenues in Q1, particularly in Europe, where the pandemic has hit especially hard. However, it is important to note that there is naturally between treatment driven revenue and cases performed at hospitals by kids and adults and use them over time. In the US, 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 HIFU treatment numbers as compared to Q1 of last year, and also sequentially as compared to Q4 of 2020. This is impact driven by the adoption of the Category 1 CPT code since its official implementation in January of 2021, as well as the broadening awareness of HIFU as an important addition to the urology [indiscernible]. Turning to a very strong cash position, we ended the first quarter with cash and cash equivalent of EUR 24.4 million or $28.6 million, as compared to EUR 24.7 million 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 Depository 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 US and elsewhere. And now, our CFO, Francois Dietsch will provide some details of our financial results. Francois?

Thank you, Marc. And good morning, everyone. Please note that all figures, except for percentages, are in euro. For conversion purposes, our average euro-dollar exchange rate was 1.990 for the first quarter of 2021. Total revenue for the first quarter was EUR 10.3 million, an increase of 35.4% versus EUR 7.6 million in Q1 2020, this reaching a new record level for our first quarter. Total revenue in the HIFU business for the first quarter of 2021 was EUR 1.8 million, a decline of 6.2% compared to EUR 1.9 million for the first quarter of 2020. The moderate decline is driven primarily to the effect of the early pandemic which continues to add up really in fact for heavier volumes also we are noticing a positive trend. Total revenue in the LITHO business for the first quarter of 2021 was EUR 2.9 million roughly flat compared to EUR 2.9 million for the first quarter of 2020. The total revenue in the Distribution business for the first quarter of 2021 was EUR 5.6 million, a 102.5% increase compared to EUR 2.8 million for the first quarter of 2020, thanks to the Exact Imaging and the major sales development. Gross profit for the first quarter of 2021 was EUR 4.4 million compared to EUR 3.1 million 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 sales effect on fixed costs. Operating expenses were EUR 4.1 million for the first quarter of 2021 compared to EUR 12.5 million for the same period in 2020. Operating profit for the first quarter of 2021 EUR 0.2 million compared to an operating loss of EUR 1.5 million in the first quarter of 2020. Net income for the first quarter of 2021 was EUR 0.8 million or EUR 0.03 per diluted share taken into account of EUR 0.2 million financially in term linked with the US Paycheck Protection Program for the units as compared to a net loss of EUR 1.2 million, EUR 0.04 per diluted share in the year ago period. We ended the first quarter with cash and cash equivalents of EUR 24.4 million or $28.6 million as compared to EUR 24.7 million or $30.2 million at the end of December 2020. Subsequent to the end of the first quarter, we completed an underwritten public offering of American Depositary Shares that same yielded net proceeds of approximately $25.6 million as a result, our pro forma cash currently stands at approximately $64 million. Our pro forma ADS share count stands at approximately 33.4 million shares, including of 4.15 million ADS issued pursuant to the underwriting offering. And we now turn the call back to Marc.

Thank you, Francois. 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 clinically proven technology leading to better patient outcomes, a clear and consistent messaging into our distribution channels, a strengthened balance sheet capable of supporting our future growth and key strategic partners who are helping us secure attractive reimbursement for Focal One procedures. Despite continued challenges from the pandemic, 2021 promises to be a year in which our company transforms the treatment of prostate cancer and longer-term, we remain extremely confident in the potential of our HIFU technology to address multiple therapeutic opportunities. We will now open the call to your question. Operator?

Thank you. The floor is now open for questions. [Operator Instructions] Our first question is coming from Jason Bednar of Piper Sandler. Please go ahead.

Hello. Hope everyone's well. My first question, Marc. You mentioned growing demand with HIFU here in the quarter you know 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?

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 US 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 the other part of the question, sorry.

It was just on what time 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?

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, 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 understand you still need to make the investments? Can you talk about that any time then when we should expect to see returns from the investments and you know account for this in our models?

Can you, sorry, Jason, I believe the line is not too good. But I didn't get the first part of your question. Can you repeat that?

Yeah. I was just 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 and I understand this won't come immediately, but it should be expecting to, you know, 3 month to 6 month lag, 6 month to 12 month lag and when these, the, again, the fruits of the investments start showing up?

So, well actually, you know as I said a few times, it's too early, the beginning of the year, the beginning of the budget cycle so and within the context of the pandemic, still it's difficult to have a very clear visibility on the assessment 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, so it's a - we work on building coverage and market acceptance, and as we discussed several times it's something that takes a lot of time, though we expect to you know 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 and in execution all for accelerated plans and actions in order to get into that as quick as possible. And therefore, generate return as fast as possible as well.

Okay, right understood. And then maybe just one last one for me. Marc, 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?

It's all about coverage. Again, as I said, we, you know, we got the CPT code implemented at the beginning of the year, and now we need to build company coverage, we need to recruit I mean 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 positivity issues. And on the other hand, the idea is to get private payers starting to get into their policy the HIFU reimbursement. So that this is the plan and these are the mixes.

Right, understood. Thanks so much.

Thanks, Jason.

Thank you. Our next question is coming from Andrew D'Silva of B. Riley. Please go ahead.

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, Ablatherm, ESWL and Exact Vu Systems were placed in the quarter? And while that info is being pulled? I'm just kind of curious why Exact Vu seems to be moving at a much stronger pace than even the HIFU segment. Can you just talk about I mean what's driving that relativity, even Focal One which you know, has its own reimbursement and is really a very, very complementary offering. And both have a capital equipment needs? So I was just very surprised by the product mix.

Okay. Hello and thanks for the question. So it's a long question so I may ask you for to repeat the second part of the question. But as far as equipments sold, we got 6 LITHO printers, 5 Exact Vu machines and we had no HIFU devices in the first quarter as the same as last year. And the rest of the question what was about?

Just really trying to understand why Exact Vu is progressing so quickly, even relative to Focal One, particularly both - since they're both capital equipment items and very complementary to one another. So I've just been very surprised by the over performance of Exact Vu, particularly in regard to HIFU.

Yeah, actually it's a good question though. The capital investment is significantly different in purchasing a Focal One or an Exact Vu, it's like more than 3 times more expensive to buy a Focal One. So it's very different. The indication is different as well, I mean, the Exact Vu is used to perform diagnostics of prostate cancer, when Focal One is for the treatments. 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, is significantly higher on Focal One, they are in the US, as I shared on a frequency basis you know about 1 million biopsies performed every year on prostate and typically Exact Vu addresses 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 sold 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 have much more diagnostic equipment in the field and for the equipments.

That makes sense. And as it relates to Ablatherm 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 of systems. So I wasn't sure if we should be thinking about Ablatherm in any sort of material way going forward? Or if those are more one-off situations?

Yeah, no, that's more punctual and the important thing as well is that, we don't manufacture Ablatherm anymore. And the Ablatherm machine we sold are usually secondhand or refurbished equipment. And in the case of the equipments we sold at the end of last year that were secondhand machines, you know, we did in the past some trading program for our Ablatherm users in the US to upgrade to a Focal One. So they were buying Focal One and we were traded in the Ablatherm. So, for those that want to invest little money in getting into HIFU to secondhand Ablatherm are good opportunities. So it's really a punctual and optimistic business.

Okay. Okay, perfect. And last quarter, you referenced your partnership with MTP and Argenta. I was just curious to 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?

We just - 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 sticking with private payers and we actually already started to do some meeting with the medical directors of private insurances. And 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 support their cases and get this claim done and covered. So it's all about this kind of an initiative. And as I said as well as we now have completed the final thing, we will increase further the action plan in helping our sites, in lobbying the payers and in building more coverage with business partners, but also with key people that we're going to get into our team.

Okay, but nothing should really materially deviate beyond what we've previously talked about as far as the commercial coefficient multiplier being you know 1.5 times to 3 times higher than that of Medicare, correct?

Yeah, we're not there yet. But that's ultimately when they decide to cover, they will use their usual multiples that can be viable from one to the other.

Okay, and last question. Just trying to get a little more granular on what kind of investments we should be expecting from a US commercialization standpoint, now that you you've got the recent capital infusion? Could you maybe just discuss where you are today with your salesforce and support of the reps that are focused on US 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 that would be very useful. Thank you very much.

Yeah. Thanks for the question, though. I mean I don't have yet you know, the way 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 salesforce that will increase, but also in the marketing and clinical departments so that we have more actions and initiatives on that side as well.

Okay. But just say today, do you expect it to be like 2 times or 3 times bigger as far as the size of the salesforce and marketing team and clinical teams domestically in aggregate?

Yeah. That will be, you know, again, as much as possible. Now we have all the ingredients like I said, to move forward and deliver and execute. Now it's another question as well of opportunity. And again, you know, the idea is not just to double or triple the salesforce, the idea is to get the best guys. So, I don't want to double my sales force with, you know, with people that will not sell. I want to get the best sales people. And that's what we're 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 who if I can just increase it 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 ID is to go the fastest way possible with the best quality of people and partners involved in our programs so that we can achieve it successfully as quick as possible.

Very good point. Thank you very much. Best luck -

Thanks, Andy.

Really looking forward to watch the progress.

Thank you.

Thank you. Our next question is coming from Frank Takkinen of Lake Street Capital Markets. Please go ahead.

Hey, thanks for taking my questions. Wanted to start with Exact Vu? Marc, could you update us on roughly speaking the overlap of sites with both Exact Vu and Focal One? And then I wanted to kind of target the sites that do have an Exact Vu installed? And how you view that opportunity to sell Focal One into?

Yeah, that's a good question. And again, the complement between the two technologies and devices is evidence on 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 Exact Vu. And then once you have that level of capability of diagnosing prostate cancer, then you want certainly to do some targeted and focal treatments. And that's where Focal One fits perfectly Exact Vu. So again that's really the way it has a good complement. And that's really the way they work perfectly together. On your - on the second part of your question, it is true that the pipeline of projects or the install base of Exact Vu, 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 diagnostics is to be able to do focal treatment or targeted treatment. So these are extremely good candidates to initiate a Focal One project. So that's, I mean, indeed, all those existing Exact Vu users are extremely good candidates and target for building project in Focal One and generate the datas.

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 enrolling a couple of patients but could you just update us on expected milestones over the next 12 months 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, 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. Focal One is approved 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 were doing, the Phase 2 study and probably a Phase 3 study that will conduct after this one, we'll be key in the regulatory path towards CE 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 complete recruitments on the Phase 2 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, we've done already half of the equipment, we've got 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 5 centers that are involved in the multi-centric study Phase 2. 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 2 studies are enough to get into a regulatory discussion or shall we need to get started on the Phase 3, which we'll start in any case, just like you said to get some technical data. So this is a little bit the program and the different milestones in front of us.

Got it. That makes sense. And a 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?

It's - yeah, it's a good assumption looking at it that this way and as you know, HIFU contribute very positively to increasing the gross margin. So that's what we see.

Perfect, thanks for taking all my questions.

Thanks, Frank.

Thank you. Our next question is coming from Swayampakula Ramakanth of H.C. Wainwright. Please go ahead.

Thank you. This is RK. Good afternoon, Marc.

Hello, RK.

Hi. Ablatherm and Focal One have been with some of the tier one organizations as for a 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've exhausted all the leads within the tier one institutions? And what learnings have you gotten from these - from the experience from these folks that you can take to the next level? Now that you have the CPT code probably at the discussions are a little bit easier to get to the tier two institutions.

Well, thank you, RK 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 US and about 1,500 to 1,700 of them are having a urology department dealing with prostate. The tier one 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 One and we had a few additional other terms. So we're far from saturating the tier one. And we have a lot of potential on that and most of our current leads in the pipeline that, as I said, continuing to increase are within that category of tier one 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 sales. And as you say, ultimately, when 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 that.

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 the adoption. So towards that end, obviously you have, you know, picked up and you've been working with this consultancies for a while now. So in this - in the road to getting complete reimbursement or more of the reimbursement wins, what are the potential next steps, you know, now that you have the CPT code and also just trying to figure out, does that help you to - help some of these centers to increase the procedural rate? And because last time we were talking, you know, 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?

So basically that's a little bit what I said before today. First, we need to - the next steps are getting more covered lives and that's to getting LCDs from the Max on CMS Medicare patient side. And that's by getting more and more private insurance, including HIFU in their policies as it was in the policy. So these are the next milestones to recruit these payers and have them covering the technology on an incremental basis. What we are doing and like we said, you know, when you have a new technology, when you have a new code, it's always a challenge and it's always need help support notification even on big reference centers to have them claim properly. And that's what I just explained a few minutes ago, in explaining some of the actions that we are now putting in place and increasing intensive support. And that's part of it is the hotline that we've created to support all of our user 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 volume here.

Thanks. Thanks for taking my questions.

Thank you, RK.

Thank you. At this time, I would like to turn the floor back over to management for any additional or closing comments.

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 earnings call in summer. Thank you very much. Y'all have a good day.

Ladies and gentlemen, thank you for your participation. You may disconnect your lines at this time and have a wonderful day.