Greetings welcome to the EDAP TMS Fourth Quarter and Fiscal Year 2019 Earnings 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 my pleasure to introduce your host Jeremy Feffer. Thank you, you may begin.

Thank you, Michele. Good morning and thank you for joining us for the EDAP TMS fourth quarter 2019 financial and operating results conference call. On today's call, we will hear from Marc Oczachowski, Chief Executive Officer and newly appointed Chairman of the Board; and François 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, Jeremy. And thank you everyone for joining us today. On today's call, we will keep our comments related to fourth quarter and full year 2019 results shorter than we normally would as we want to provide you with as much transparency and information as possible related to our actions and plans to manage EDAP TMS through the COVID-19 virus. This is a new challenge for all of us and we want to do our part in protecting our employees and continuing to serve our customers as best as possible. But before returning to the results, I wanted to take a moment to express thanks on behalf of myself and the entire EDAP Board and leadership team to Philippe Chauveau. As we announced in our press release last night, Philippe is stepping down from our Board as part of a long established transition plan and will remain as Director until June 2020. Philippe has served on our Board since 1997 and over the years, has provided invaluable guidance and insight that has been a major factor in what EDAP has become over the years, a widely recognized leader and innovator in the field of robotic therapeutic milestone. We wish Philippe well in whatever the future holds for him. Turning now to the results, we are proud of the successful year in 2019 where we generated record company revenues, extended our gross margins to a record of 47%, and were profitable and cash flow positive for the full year, and maintained a very strong balance sheet. We grew our U.S. install base by 53%, which was led by well-regarded new Focal One HIFU customers, including the Mayo Clinic, Houston Methodist, University of California, Irvine, and University of Chicago. We continued to grow our Focal One HIFU customer base outside of…

Thank you, François. Again, we are very proud of our team for a very successful 2019 and excited about the opportunity to drive significant commercial adoption of the Focal One HIFU device. We are mindful of the potential short-term disruption that the COVID-19 virus may present to our business, but we hope to manage through the pandemic with the plan in place and to be well-positioned once the public health crisis is mitigated. We wish for everyone's health and safety during this very challenging time, and we'll continue to focus on supporting our employees and customers. We look forward to providing you with our next quarterly update in May. We will now open the call to question. Operator?

Thank you. We'll now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Brooks O'Neil with Lake Street Capital Markets. Please proceed with your question.

Good morning, Marc and François. Can you hear me okay?

Good morning Brooks. We hear you very well.

Okay, great. So, as an international company and as a company that had a really nice success, beginning to penetrate the large academic medical centers, I'm curious if you could just amplify a little bit about what you're seeing right now, particular outside the U.S., and in particular, also within those large medical centers, both in the U.S. and around the world, in terms of just how distracted they are with C-19 situation, whether you think they will continue to be open to reviewing Focal One and positive impact it can have in treating patients that are affected with the conditions you treat?

Yes. Well, like I said we see obviously a huge focus on emergencies related to C-19 virus situation. So, most of non-urgent or non -- very urgent procedures are now canceled. So, we are seeing most of the most of the treatments on both ESWL and HIFU are being postponed and cancelled. The thing is that the majority of these treatments as well not only are not emergency treatment, but also can be scheduled. So, we strongly expect that those patients that are not being treated now would be treated later. So, that's why we also are explaining that we are making everything so that we can be prepared when the situation goes back to normal, we may have a more business and more work than usual and people will be lining up for getting treated. But the situation today in most hospitals of the world are really to keep the most space possible to the current crisis and COVID-19 virus. In depth administration, it is the same; they are focusing their efforts and investment in providing medical care and providing medical consumables and devices to help fighting against the virus more than anything else.

Okay, I get that. That makes a lot of sense. Thank you for that. I'm curious if you have any thoughts about any impact of the current crisis and timetable related to the review of reimbursement, which I think is mostly planned to come into place in 2021, but any thoughts there?

It shouldn't have any effect on that as it is a pretty well-organized process. As you understood as well a long-lasting process because things were decided last year, they are also in place this year to be executive next year. So, we don't -- but again, we have to be cautious there, we don't anticipate any delay that particular project of reimbursement and CPT 1 could put on place next year. But again, it will also depend on how long the crisis lasts for and how disruptive it becomes to be not only for hospital, but also for administration. So, so far, we got no feedback, and again, we don't believe it may be impacted by that.

Okay, that's great. And then one last one and I forgot to say congratulations on becoming Chairman of the Board, but I was curious with Philippe stepping down as Chairman and then ultimately, leaving the Board in June, would you expect him to continue to be involved with the work with endometriosis? Or do you think he is going to go back on this thing down the road?

I don't get your question, is a question about why Philippe leaving the Board in June or what exactly is the question?

No. I'm sorry. My question is do you expect him to continue to work, do research in endometriosis or do you think he's going to move on to things that are not really related to the work you guys are doing at EDAP?

No, actually -- as we explained and Philippe, just stepped down from being the Chairman of the Board and he will leave the Board of Directors in June, but certainly will remain in close contact with the company and myself personally to work on several strategies and high level projects with the company not being in the Board.

Cool. Thank you very much. Congratulations.

Thank you. Our next question comes in the line of Swayampakula Ramakanth with H.C. Wainwright. Please proceed with your question.

Thank you. This is RK from H.C. Wainwright. Congratulations.

Hello RK.

All right. Congratulations.

Thank you.

I know you're coming off from a great year, but this is not a year that you really wanted. I get that. We all get that. But as you're getting through this tough period, how is your commercial team maintaining their relationship? And how are they maintaining their conversation that they might have started or in the middle of a bit of a sales cycle, so that they can they can take it from the get go when things get back to normalcy?

Yeah actually the sales team, of course, that is, most of the guys are confined home and working from home as you know, visiting hospitals for sales guy is not the right time now, and not the right place to be. So, the interesting thing as well is as, again, all of our doctors' contacts, I mean all of the key opinion leaders and the key decision makers at the hospital are urologist. So, they're not completely involved even though a lot of them are trying to help the other departments involved in the management of COVID-19. But they had to leave also a number of their programs in the operating theater or in the hospital and they have more free time. So, we can we can see a lot of discussions, a lot of conversation by the phone between our sales guys and the urologist so that really helps keeping on the momentum, the interest, and also the clinical discussions between our teams and the urology departments and teams in different hospitals on which we have machines equipment, but also projects and leads going on. So, the contact is maintained with the urology people. It's a bit more difficult to keep on the relationship and the discussion with the administration like as I said, they are very focused in finding resources to fight against COVID-19, but definitely the key contacts in the hospital for HIFU or real project is definitely the urologists and they have time to keep contact with us and keep on the discussion.

No, that's good. That's good. What percent do you think of the pending sales were basically waiting for this reimbursement dollar amount to be announced so that they can procure the machine in the second half of the year and get ready for 2021 when the reimbursement opens up?

It's complicated answer to give here RK because we don't -- they don't express exactly in the different parameters that make them wait or make them want to accelerate the process. But we definitely know as we see our pipeline of projects that then come to continue to grow, I think more and more hospitals and institutions in the U.S. being in the process -- in the -- I would say the purchasing process from scratch on trying to acquire Focal One, we see that momentum growing as we move forward more closely to the to the reimbursement time. So, I think that definitely helps people to get the motivation and to get the capability as well to invest in the technology.

Okay, that's good. A couple more questions. We think about the total number of machines that were installed and delivered. Is there a way for you to give us what is the total number of machine that are installed as of today in the United States? And what part of your services and volume sales revenue make up for the revenue that is coming from the U.S. hospitals that are -- that have already installed these machines? I don't know if you can break that down for us?

Going down to that level of details might not be, but I can certainly give you a trend and as we said again we increased last year our install base of equipment by 53% which means we have around 20, 25 machines now in operation in the U.S. And as you know those machines are sold with one year warranty program, which means at the end of that year of warranty, they will go into a full service contract, which will generate additional revenue on a yearly basis. So, because install base increases significantly, that level of revenue from the U.S. will also increase significantly.

Perfect. And then one last question. Could we expect any publications or case study reports from the U.S. or from outside -- the ex-U.S. institute during 2020 and 2021, do you know of anything which are in the cards?

Yes, we know that the number of our key users are working in publishing and trying to publish papers. So, we might have some publication, but it all depends on which journal will review and accept them. And it certainly take some times, but we know that a lot of -- I mean, as you know, most -- I mean most, if not all, of our Focal One users in the U.S., for example, are big academic centers and institutions, they're just got started, so they need probably more time to generate more cases and more follow-up to get started on publications. But the rest of the world we also have a majority of academic centers and University Hospitals, and they all work on making publications. So, yes, we may have some good probability of getting some tables out this year and next.

Thank you very much, Marc. Congratulations.

Thank you.

Thank you. [Operator Instructions] Our next question comes from the line Andrew D'silva with B. Riley FBR. Please proceed with your question.

Good morning. Thanks for taking my questions. And I'm glad to hear everyone is sounding healthy today. So, to start, and just to get the COVID-19 questions out of the way, as you look at your install base and the potential capacity that exists and ability to handle a significant bolus or uptick of patients in a particular quarter assuming everything related to COVID-19 smooths over in a given period, how large are or what's possible in a given quarter as relates to your reoccurring business from how many times larger could it be relative to a standard quarter?

You mean when it will restart or right now? I didn't get the point exactly there.

Yes, basically, from your reoccurring business as it relates to the impact from COVID-19, how many times larger is the potential capacity of that reoccurring business? Say if there's a large uptick in a particular quarter down the road once COVID-19 is more resolved in the regions that you're strong in effectively, how many more procedures can be done than are typically done across your systems that are installed?

Yeah, I got your point. That's a difficult question to answer because it will really depend on -- in what condition the hospitals will be after the end of the crisis. You know, that it's -- at least in Europe, most hospitals are very crowded. They are overworking and we don't exactly know how long that's going to last. And what condition the employees at the hospital will be at the end of the crisis, and in what capacity they will be to work hard again, to get back on the business. So, we don't know. But I think the longer the crisis, the longer the way to get back on the high level of pace will be possible. So, it might take some time.

Fair enough. Thank you. That's it a fair enough answer. Thank you. And then next question just as it relates to Focal One and the potential investigator initiated studies or case series that you referenced in the previous question, do you expect those studies or are you aware if they're looking at Hemi HIFU ablation or even ablation at a leading specific level for T1 through T2b localized prostate cancer, or do you have any sort of granularity as it relates to it actually being a focal ablation?

Yes, most of current studies performed -- I mean the one we know well performed in several centers across the world are indeed on the focal treatment and focal ablation of prostate cancer. And we have a number of randomized clinical trial comparing focal ablation with Focal One whether comparing it to surgery or active surveillance. So, it's mainly -- today most of the studies again are mainly on the early stage, low-risk intermediate patients on a focal approach.

Okay, great. So, when you're referencing a focal approach, you're actually seeing potential treatments being applied at a lesion-specific level or you more granular than at a Hemi ablation level?

Some of them are Hemi ablation and some of them are more -- a bit more focused than Hemi ablation, but still taking into account the guidances and guidelines for margin.

Okay. Okay, perfect. And then last question, just as it relates to the Medicare reimbursement, is there a way that we can extrapolate the level five or level six pricing transition that took place last year with a C code, but when we start thinking about your CPT code. And then after the CPT code gets issued, what's an appropriate coefficient multiplier for us to contemplate on that for U.S. private payers?

That's really depending on each and every private payer. So, there is no real rule on that. So that will be a negotiation that we will have to have with commercial and private payers.

Okay. But when you are looking at maybe other treatments such as cryoablation, when it's reimbursed by CMS at around $8,000. Have you -- can you maybe discuss some of the ranges you're seeing with the private payers?

Sure. Absolutely.

Okay. Do you know what the ranges are though?

Again, it depends from the -- from one pair to the other, but I would say from 1.5 to three times and it's variable.

Okay, Okay, perfect. Okay, thank you very much. Stay safe and best of luck this year.

Yes, thanks Andy.

Thank you. Our next question comes from the line of Matthew Pilkington with Round Top Capital. Please proceed with your question.

Hi, Marc, congrats.

Het Matt. Thanks.

I think we all -- we keep on going on about prostate cancer, but could you just list all the things that you believe this could be useful for without tying you down to some promises? Going out 10 years, I mean, we talk a lot about prostate that you're doing all this other work which seems to be forgotten about in the general excitement about the prostate cancer therapy.

Excuse me, Matt, but I don't really understand what your question is. What -- do you want me to talk about the other programs?

Yes, the other programs. It just -- I mean, I know you're doing endometriosis; you're doing some stuff on kidney cancer -- liver--

We mainly today -- outside of prostate -- I mean beyond prostate, we are mainly focusing our operation -- clinical operation, I would say, and research on the endometriosis and as I said earlier in the call, that we are still in negotiation and again that might have some delay because of the kind of crisis to discuss with the regulators in France so that we can get our protocol approved to get started on Phase II clinical trial for the treatment of regular endometriosis. And more on the early stage research and development programs, I mean, we have a number of application that actually not including kidney cancer, but including liver metastases, including pancreatic cancer, and including a number of other applications on which we're working, but it's more -- it's much more early stage than what is endometriosis. And we've obviously are continuing to do the investigation today and that's probably a more longer term research stage.

What's the addressable market on endometriosis?

It's huge. Today, we know that about 10% of women are affected by endometriosis and the rectal endometriosis is about 20% of the 10%. So that's definitely a huge potential and a huge opportunity.

Great. And my last question is are you seeing any competition on the HIFU front from other companies that should at all -- or this are you still really the only major player in this space?

Yeah, well, in endometriosis or in HIFU, in general?

HIFU, in general?

Okay, in endometriosis, I mean, we -- as far as we know, we're the only HIFU company working on that program and there are a number of companies working on HIFU development for a number of different application. And as I have pointed out in a number of conference call, there is a society goal, ISTU, which is International Society of Therapeutic Ultrasound where we can see and each year when the Society meets, I mean, we can exchange on different programs for HIFU treatments of different pathologies and in different applications. So, we're not the only one that has a very strong momentum in terms of research and development and clinical applications with HIFU. We certainly are the leading company in terms of number of cases done with HIFU and the number of publications as well. So, we keep on leading the HIFU sector, but there is a lot of company which is a good signal as well, on the ability of HIFU to be a good treatment for ablation of different tissues.

Great. Thank you. Appreciate.

Thanks Matt.

Thank you. There are no further questions at this time. I'd like to turn the call back over to Mr. Oczachowski for any closing remarks.

Again, thank you very much for joining us today. I look forward to keeping in touch with you and in updating you on our different programs and progress. We'll definitely talk again in May for the Q1 results. In the meantime, I wish you all the best. Take care and stay safe. Bye-bye

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Have a wonderful day.