EDAP TMS S.A.

Greetings and welcome to the EDAPTMS second 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Glenn Garmont, Investor Relations. Please go ahead, sir.

Thank you, Hector. Good morning, and thank you for joining us for the EDAP TMS Second Quarter 2021 Financial and Operating Results Conference Call. On today's call, we'll hear from Mark Oksikowski, Chief Executive Officer and Chairman of the Board, and Francois Dietsch, Chief Financial Officer. Before we begin, I'd 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 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 CEO, Mark Oksakowski. Mark?

Thank you, Glenn, and good morning, everyone. I will start by providing a brief operational update and then turn the call over to Francois Ditch to review our financial performance. I will recap a few of the highlights that we covered in our pre-announcement press release of August 4. Total company revenue for the six months ending June 30 was 20.7 million euros or $24.8 million, representing growth of 22.5% over the first six months of 2020. And while our HIFU division continues to be negatively impacted by the ongoing effects of the COVID pandemic on hospital capex trends, we were very pleased to see U.S. treatment volumes increase a very healthy 79% over the second quarter of 2020. This is important for two reasons. First, the growth in U.S. treatment volumes is very noteworthy because it is a leading indicator of growing adoption by urologists of Cochlear & Haiku as a process cancer treatment alternative. Second, we believe this growth in U.S. treatment volumes reflects the positive impact of Haiku reimbursement rules that went into effect on January 1st of this year. Recall that CMS, in its Physician Fee Schedule final rule, established for the first time a payment to physicians performing a Haiku procedure in the U.S. Recapping the rule, TMS has set a total relative value unit, or RVUs, for physicians performing a HIFU procedure at 29.09. This translates to an average payment of $996 for a urologist performing a HIFU procedure on a Medicare patient in a facility setting. As a reference, a comparable established minimally invasive therapy for prostate cancer, cryotherapy, yields at 22.72 RVUs, which translates to $786 for the urologist under the same setting and patient conditions. So HIFU can significantly broaden the revenue base of urologists treating prostate cancer patients, and we believe this new rule could be a meaningful long-term catalyst to accelerating 401 adoption. And on the topic of reimbursements, I would like to share with you a recent update that could very positively impact reimbursement rates in 2022 and beyond. Earlier this week, we requested and were granted an opportunity to present at the summer meeting of the CMS Advisory Panel on Hospital Outpatient Payment, or HOP Panel. The HOP Panel is a mechanism whereby CMS brings together a group of subject matter experts to consider and discuss changes to current reimbursement rates for specific outpatient procedures or technologies. Recall that on the hospital payment side, HIFU is currently reimbursed as a Level 5 Urology Ambulatory Payment Certification or APC. This translates into a payment for a hospital performing a HIFU procedure on a Medicare patient of around $4,500 in 2021 as a national average adjusted locally based on the weight index. However, based on the analysis of the reimbursement paid for other prostate cancer ablation procedures, including cryo-surgical ablation, we believe there is a strong argument to be made for a level six APC reimbursement for 401 . For the sake of comparison, if HIFU were reimbursed at level six this year, the average reimbursement would increase from approximately $4,500 currently to approximately $8,500, a huge increase of nearly 88%. This is important because the low reimbursement for facilities limits how broadly focal therapy may be offered to the full range of Medicare patients. At the meeting which occurred this past Monday, the HOP panel voted unanimously in favor of the increase. And while the final 2022 rule will not be published until November or December of this year, it is worth noting that CMS has historically given the HOP panel's recommendations very strong consideration. If we are successful in moving our APC classification to level 6 from level 5 next year, we believe this will be a significant driver for many more hospitals to initiate a focal therapy program. financial analysis of acquiring a focal one machine and offering the critical benefits to a broader patient population becomes much stronger. We are very excited and hopeful that these potentials change and look forward to progress later this year. Notwithstanding the challenging CAPEX environment during the second quarter, we continue to add to our robust pipeline of focal one and ExideU pipeline sales opportunities during the quarter, and we believe Several will close this year. Over the past few months, we have added healthcare institutions who are growing focal one clients roster, including Cleveland Clinic and Mount Sinai in New York, among many others. These are notable leading institutions in the treatment of prostate cancer and are increasingly becoming reference centers with teaching, research, and case observations now available for pipeline accounts. We look forward to updating you on the growth and development of our Centers of Excellence for Formula One in the coming months. We believe that the eventual return of Hospital CapEx to a more normalized trend, coupled with continued growth in treatment volumes, bodes well for the future of our company, as well as the hundreds of thousands of men around the world who could potentially benefit from this treatment. Turning now to other highlights from the quarter. In June, we announced the hiring of Medtech industry veteran Ryan Rhodes to be chief executive officer of our U.S. subsidiary. Ryan brings a wealth of highly relevant experience, including 14 years at Intuitive Surgical, where he played a leading role in the global clinical extension of robotic surgery in multiple specialties, including urology. The addition of Ryan reflects the continued execution of our U.S. expansion plans. He will be instrumental in helping to drive continued growth and adoption of our technology. Ryan has already started assembling a world-class team around him by adding MedTech leaders that will be instrumental in building HICO adoption and utilization in the country. One of them is Mohan Nathan, who has an extensive background in the medical device industry, including many years in global clinical and marketing leadership roles at Intuitive Surgical and Transcentrics. Mohan will play a major role at EDAP, developing our clinical and marketing adoption programs. To fund our growth initiatives in the U.S. and elsewhere, in April, we completed a successful financing that raised gross proceeds of approximately $28 million. Together with Cash on Hand, we ended the second quarter with a cash of more than $53 million. As we discussed last quarter, this financing was strategically important for several reasons. First, it brought a number of new, high-quality institutional healthcare investors into the fold. These investments occur only after a significant amount of due diligence has been done, and the investors who participated in this offering did so because the share or belief in the potential of HIFU not just as part of the process cancer continuum, but potentially other indications as well. We believe this validates our mission and our technology. The funds that we raise will support our U.S. extension plan, specifically our efforts to expand market access and increase the IFO adoption and utilization. We previously announced that we are working with leading U.S. reimbursement consultancies, NTP, and Arkansas advisors to expand market access and coverage And this reflects our broader commitment to establish ourselves as the leader in the U.S. market, making focal technology as broadly available to patients as possible. We also have sufficient capital to build out our clinical marketing and sales organizations. I believe that these initiatives, together with the hospitals and KOLs, who are already champions of technology on the ground, represent a multi-pronged approach designed to maximize awareness and access to our HIFU technology. I will provide a brief update on our endometriosis program. As a reminder, this Phase II 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 technology. Enrollment is tracking closely with our internal expectations, and we expect to treat the last patient by the end of this month, which is in two or three days. We also received authorization from the French Health Authority to continue enrolling patients after we achieve our initial enrollment target of 38 patients to further strengthen this Phase 2 study and collect more safety and efficacy data. We believe the treatment of endometriosis could be greatly improved with the application of lase-invasive procedures and the use of hypo-technology could offer an important minimally invasive treatment option for these patients. And now, our CFO, Francois Ditch, 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 euros. For conversion purposes, our average euro-dollar exchange rate was 1.2024 for the second quarter of 2021. Our total company revenue for the second quarter of 2021 was 10.4 million euros, an increase of 11.8% compared to total revenue of 9.3 million euros for the same period in 2020. Looking at the revenue by division, total revenue in the IQ business for the second quarter of 2021 was 2 million euros, a decline of 21.8% as compared to 2.6 million euros for the second quarter of 2020. The decline was driven primarily by continued weakness in hospital capex spending, as Marc alluded to earlier. Total revenue in the little business for the second quarter of 2021 was 2.3 million euros, a decline of 22.6% from 2.9 million euros for the second quarter of 2020. As for IFU, the decline was driven by continued weakness in the Spital CapEx spending. Total revenue in the distribution business for the second quarter of 2021 was 6.1 million euros, a 61.6% increase compared to 3.8 million euros for the second quarter of 2020, thanks to the exact metering and laser cell development. The profit for the second quarter of 2021 was 4.2 million euros compared to 4.3 million euros for the derogatory period. The profit margin and net sales was 40.7% in the second quarter of 2021, compared to 46.8% in the year-over-period. The decrease in both profits year-over-year was due to lower sales effects on fixed costs and the high food business. Our operating expenses were 4.6 million euros for the second quarter of 2021, compared to 4 million euros for the same period in 2020. The rating loss for the second quarter of 2021 was €0.4 million, compared to an opposing profit of €0.3 million in the second quarter of 2020. Net loss for the second quarter of 2021 was €0.4 million, or one cent of two euros per deleted share, as compared to a net loss of €0.3 million, or one cent of two euros per deleted share in the year-ago period. At the end of June 2021, we had cash and cash equivalents of 45 million euros or 63.3 million US dollars as compared to 24.7 million euros or 30.2 million US dollars as of December 31st of 2020. Including in our June 30 cash balance is net proceeds of approximately $25.7 million from the secondary offering of IDS that we completed in April. Reflecting the offering, the number of outstanding shares was approximately 33.4 million shares at the end of June 2021. And we now return the call back tomorrow. Thank you, Francois.

In summary, we are pleased with our second quarter results against a difficult hospital capex environment. Through the first six months of the year, we increased revenue 22.5% over the comparable period in 2020, demonstrating that we are successfully navigating through this crisis. In addition, we carefully and successfully managed our growth margin and operating expenses to keep the company near break-even. At the same time, we continue to build our U.S. pipeline and we remain optimistic that we will announce additional sales and key placements very soon. We also anticipate that treatment revenue growth will accelerate as we saw with the positive momentum in utilization during the first half of the year. And this should be strengthened by a new U.S. structure and resources. The most important leading indicator U.S. treatment volume increased 79% year-over-year, reflecting growing awareness of HIFU as well as the positive impact of the new reimbursement rules that went into effect in January. Finally, we are very, very excited about the results of this week's meeting of the CMS HIP panel and its positive and favorable recommendations towards the upgrade from ABC Level 5 to Level 6 of HIFU Reimbursement Code 55880. Again, a new reimbursement for high-freeze upgraded to level 6 next year, this will represent a significant increase in dollars to hospitals performing focal wound procedures, and we believe drive accelerating machine placement in the future. All in all, I believe we are very well positioned to establish ourselves as the leader in the non-invasive and focal ablation of prostate tissues. I would like to thank you for your interest and support. We will now open the call to your questions. Operator?

Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 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. One moment, please, while we poll for questions. Your first question comes from a line of Frank Takinen with Lake Street Capital Markets. Please proceed with your question.

Great. Thanks for taking my questions. A couple for me this morning. I wanted to start with the reimbursement change. I was just hoping you could give us a little bit more background in why it was previously categorized into level five and the more specific justification to get it to a level six. And then, although I am very excited and can completely appreciate the jump up here, is there opportunity to increase the reimbursement even more from the level six reimbursement level in future years?

Hi, Frank. Well, thanks for the question. Well, actually, the Level 5 reimbursement was given by Medicare some years ago after it was started with the C code on the Level 6. And then after the first claims that were made by users of the IQ technology, one year or two years after, they decided to put it to Level 5 based on the average amount claimed. So that's why we spoke about that in previous calls. We also initiated some programs in educating hospitals and users to properly claim their high for treatment to Medicare. And we have significantly increased and improved that average amount to be claimed. That will also be a justification of upgrading the APC from level five to level six.

And that's what we've been discussing with CMS as well as the HOP panel at the beginning of the week.

Got it. Okay. That's helpful. Wanted to move over to capital budgets a little bit more. Heard your comments about potentially announcing some key placements very soon. Was curious if you wanted, if you could help us understand how conversations are going as of recently. I know there was an expectation for a second half bolus of placement, similar to what happened last year. Do you still think that that's something that could be occurring this year? Or do you feel there's maybe a little bit more conservatism, cautiousness, whatever you want to call it, in CapEx budgets right now?

Well, I think we're about in the same situation as last year, where all the seasonality of this type of business has been even increased because of the current lack of visibility in the COVID context. And we really hope that, like last year, a lot of people will have to spend budgets anyway before the end of the cycle, which is the end of the year for the majority of hospitals. And as far as the discussions are going, I mean, we are having very, very regular frequent discussions with administrations purchasing department and legal department in a significant number of leads and hospitals in the U.S. with the goal of finalizing and closing deals before the end of the year. That's why I was telling earlier that we have good hope and confidence that we might be able to announce and close key placement and sales soon and most probably before the end of the year.

Got it. Okay. Last one for me. Saw distribution had a pretty solid quarter. I'm assuming this was related to exact view. One, can you confirm if that's correct? And two, can you give us a little bit more color on the sale of the exact view systems, how many you had this quarter, as well as rough estimate on the install basis?

Yeah, you're exactly right. As you remember, on the first half of last year of 2020, we didn't have yet the distribution rights for ExideU. We actually initiated at the end of the second quarter last year, so we only had a few sales last year. And this year, we were already commercializing it since a month, so we were full speed in commercialization, at least in the U.S. and a big part of Europe. And we've done nine sales of ExideU during the quarter, this year as opposed to only three last year because again, we just got started in the month of June. So that has been tremendously indeed helping to grow the global number of our distribution business as well as some good momentum and good deals in lasers in France and Asia. And this is made a bit easier to sell as the capital expenditure is much lower than what could be for a focal one.

So that's also why we've been able to navigate a bit easier on that environment. Got it. Thanks for taking my questions, and congrats on all progress. Thank you, Frank. Your next question comes from the line of Jason Bednar with Piper Sandler.

Please proceed with your questions.

Hello, hope everyone's well. Good to see you. A few questions from our side.

Hey there. Just a couple of, just to follow up here first on those prior questions. First, Mark, I wanted to start to see if you could expand maybe a bit further on what you're hearing. Just on the ground, your discussions with hospitals, I know you mentioned kind of the COVID dynamic, but are you getting the sense that budgets are still tight? Is it the technology education and sales negotiation process that's challenging in the COVID environment where access may still be limited, or are there maybe some other external factors that have been holding back demand from hospitals?

Well, I think it's a mix of all these, actually, and it's true that the access is a bit more difficult. The focus as well on expenditure from hospitals is a little bit different than could be usual. Priorities are different. And when you speak about big amount of money, and again, like I just said, if it's small capital equipment like stone lasers or or even the exact view device, the education or priority is less difficult to overachieve than if you are speaking about a $700,000 or more investment for the hospital. So it's just a little bit more time and also a question of priority, and that's probably why a lot of things will happen later. towards the end of the year when they don't have any more time to wait. So they have to make the decision like it happened last year.

Okay, that's helpful. And then moving over to the update from the HOP panel, that is really encouraging news, and you can congrats on that update. And as you mentioned that this would put HIFU on a more level playing field with cryo and radical prostatectomy. Can you elaborate on how influential you believe the payment increase could be on influencing focal one purchases if it goes into effect. I mean, it seems like it has the potential to be much more impactful than the physician fee schedule update for this year in terms of just driving future system adoption. But I guess we'd love to hear if you agree and whether you have any additional color you can provide on how this might ultimately maybe influence commercial payers down the road.

That will definitely influence first. I mean, the That will help, again, hospital getting into the technology faster because when you almost double the level of payment the hospital will get for the same technology, that really changes the performer in favor of the technology. So that will definitely help accelerating and boosting the sales and also the use of the technology. So it's on both sides, not only on the CapEx, it's also on the disposable side. For the private payers, I mean, for the insurances, as again, they usually base their reimbursement level on Medicare reimbursement levels. So that will also influence the private payers. And again, the private payers, the more adoption, the more utilization, the faster you're able to enroll private payers and have the technology and the policies.

Okay, I guess just maybe to follow up just on one point there, just to clarify, maybe how this might drive some better hospital adoption. When you go out and try and sell focal one, I guess, how much pushback do you run into simply because the ROI or the economics aren't as favorable as the hospitals would like them to be?

Not much, because already, again, like we said, the ROI or the breakeven point, and again, remember that the CMS payment is only for Medicare patients, so you have to account as well with private paid patients. that are also contributing to the ROI. So the performance is good already. It will be just excellent if we move into level six. So we don't have too much of blockage or whatever today at level five. It's just that it could be much better at level six.

Okay, all right, great. And then just one, I'll squeeze in one final one for myself. And I appreciate the update on just how Ryan's already building out his team. But sorry if I missed it. Are there any targets we should have in mind with respect to the number of folks or roles that Ryan plans to fill and by when he's hoping to have that desired talent in place?

No, actually, I mean, for obvious reasons, we won't disclose the complete plan and strategy and all that. I mean, we also have to take care of others and competitions and the environment. But the idea is really to build a global and strong and highly performant team of clinical marketing and sales people to really, again, spread the technology, educate the users in the market, as well as the patient community. And again, Ryan, with his expertise and extremely long-term and successful experience, in building programs to penetrate the market with disruptive technology as a very broad network in the medical field and particularly in urology. And I'm very confident he will continue to bring on board a number of talents that will help us to really get very aggressively into the market and accelerate the penetration of HIFU as well as the

the utilization of our current space. Great. Thanks, Mark.

Thank you, Dylan.

Your next question comes from the line of Andrew DaSilva with B Reilly Securities.

Please proceed with your question.

Hey, good morning. Thanks for taking my questions. Just a few quick ones for me. Could you let us know just how many focal ones and ESWL systems were replaced during the quarter? And were there any ablotherms installed during the quarter?

No, we had no ablotherm, and we're going to get less and less ablotherm in the future, of course, as focal one has really taken over. We've got one focal one sold during the quarter. And in terms of electricity for renewable well, we had about three units sold during the quarter.

Okay, thank you for that. And then could you just, I know you touched on this briefly, but just a quick recap on what next steps for EDAP are from a commercial reimbursing standpoint, like what should we be monitoring on our side? And then with the move to level six, and its alignment with cryoablation, the increase from $4,500 to $8,500, is that just the facility fee, or does that also include the physician fee as well?

No, that's just the facility fee. The physician fee is a separate fee.

Okay. So all in, if you get to level six, we should be thinking of something around close to $10,000.

I mean, for both fees, yeah, because we have one that is close to $1,000 and the other one would be around $8,500.

Okay. Perfect. And just from the next steps as it relates to the commercial reimbursement standpoint, what should we be charting?

Can you say that again? Sorry.

From obtaining commercial reimbursement, what should we be charting going forward to kind of to see how you're progressing.

You mean from private payers or is that a question? Yes, yes. We're working on, as I said in the past calls, we're actively working on that and we will continue to work on that with the different private payers as well as the insurances. And that's a long process. So, again, the idea is to, as quick as we can, start getting some of these companies offering the treatment in their policies. And, again, it's a long process, and we're very actively working and investing in that direction. So we'll keep you posted as far as we have material information on that.

But is it tracking to your expectations right now, or have there been any delays or changes? things moving actually ahead of schedule.

Actually, we're executing our plan as anticipated, so we're on track in terms of delivering the actions, meetings, and plans. Okay.

Just last question for me. How indicative of your future OpEx was the second quarter? Or could you just kind of give us a sense off the second quarter, you know, what should we kind of model an increase in OPEX given the expansion in the U.S.

infrastructure?

I'm not sure I'm getting your question, Andy, there. What do you want to know exactly?

I'm sure I get it. Using the second quarter as a baseline, what

percent do you think your opex will need to increase for you to properly establish the u.s infrastructure that you're trying to do with ryan oh i mean i i won't be able to give you an exact percentage but yeah we we have to expect significant increase in our in our opex in the us as again we want to build that complete global marketing clinical and sales organization so and and And we will start seeing the impact of that on the second half of the year as, again, Ryan joined the company in June only. So he's working very hard on building that team of talents, again, that will bring the company to the next level. So, yeah, we'll see the impact of that in the coming quarters.

Okay, great. Thank you.

I'll take everything offline. Best of luck going forward. Thanks, Andy.

As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. One moment, please, while we poll for more questions. Your next question comes from line of Swayam Pakula Ramakant with HC Wainwright. Please proceed with your question.

Thank you. Good morning, Mark and Francois. This is RK from HC Wainwright. In the opening remarks, you stated that you've been seeing growth in terms of treatment volumes. Could you give us a little bit more color, either in terms of percentage or total number of treatments being done using HIFU?

Yeah, the overall percentage that I gave it, compared to last year, we did about 79-80% growth. Then it's pretty well spread among most of our sites. We can really see a momentum in utilization most of our existing reference sites. So that's a common kind of trend, which is very encouraging. Again, people are getting more and more confident and more and more the benefits for the patients. So the volume of patients is increasing in most of our key opinion centers.

Perfect. And then also in terms of what Ryan and his team would be working on, do you think they would also not only on trying to meet with additional hospitals and oncology centers, would their efforts be also in terms of messaging more about the utility of HIFU and in the same way, are you trying to get any additional publications out so that it helps in Ryan's work.

Absolutely, absolutely. And we're continuing to follow some studies here and there to get more publication on HIFU. And again, the focus of Ryan and his team and the way he's building the team is to really push utilization, not only to push the sales of equipment to spread the technology to more key hospitals and key opinion leaders in the country, but it's also to work on programs with the hospitals in terms of clinical utilization and adoption, and again, further increase the utilization of the technology in the existing hospitals.

You probably answered this question earlier, but I just want to make sure I get this correctly. when you were talking about how the reimbursement could get approved at the APC level six, is that the same level as what cryotherapy and radical prostatectomy is getting reimbursed at, or would this be slightly better than those therapies?

And as I said during the call, that will be in the same level as cryosurgery. Radiculopectomy is in another classification, so we can compare. But it will be, yes, in the same level as cryosurgery.

Perfect.

And then the last question from me... And as I said, just to be complete on that, RK, so that's again, as Andy was clarifying, that's for the... That's for the technical, that's for the hospital fee only. And for the fee, we will still have a much higher reimbursement than cryosurgery. So all in all, it would be much more favorable for high food than cryo.

Perfect. That'd be good. The last question for me is, when I look across the UDS division, the sales in the second quarter seem to have dipped quite a bit compared to the last six quarters. So what's changing in that commercialization? Is there something in the market or is there something that you need to kind of correct it within the firm?

I'm not sure, RK, because we don't speak about UDS anymore. As you remember, since some quarters, we have spread UDS between ESWL and distribution because it was not making any more sense to have them together. So do you speak about ESWL or distribution?

I'm just looking at the UDS division revenue. But we can take that offline.

Okay. Thanks.

Ladies and gentlemen, we have reached the end of the question and answer session, and this does conclude today's conference. You may disconnect your lines at this time. Thank you all for your participation.