NASDAQ:EDAP EDAP TMS Q2 2023 Earnings Report $1.69 -0.01 (-0.59%) As of 06/20/2025 04:00 PM Eastern This is a fair market value price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast EDAP TMS EPS ResultsActual EPS-$0.14Consensus EPS -$0.03Beat/MissMissed by -$0.11One Year Ago EPSN/AEDAP TMS Revenue ResultsActual Revenue$15.52 millionExpected Revenue$17.36 millionBeat/MissMissed by -$1.84 millionYoY Revenue GrowthN/AEDAP TMS Announcement DetailsQuarterQ2 2023Date8/24/2023TimeN/AConference Call DateThursday, August 24, 2023Conference Call Time8:30AM ETUpcoming EarningsEDAP TMS' Q2 2025 earnings is scheduled for Wednesday, August 27, 2025, with a conference call scheduled at 12:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Earnings HistoryCompany ProfilePowered by EDAP TMS Q2 2023 Earnings Call TranscriptProvided by QuartrAugust 24, 2023 ShareLink copied to clipboard.Key Takeaways EDAP reported record Q2 revenues of €14.3 million and 63.6% year-over-year growth in HIFU revenue, driven by four new U.S. Focal One capital placements and higher disposable sales. U.S. procedure volumes for Focal One HIFU surged 85% year-over-year and 29% sequentially in Q2, reflecting strong adoption among both legacy and new customers. Key strategic milestones include first Focal One placements in Kansas and West Virginia, a sale to Memorial Sloan Kettering Cancer Center, and new reimbursement approval in Switzerland effective July 1, 2023. Q2 operating loss widened to €4.2 million (net loss €4.7 million or €0.13 per share) versus a prior-year operating loss of €0.4 million, pressured by distribution mix, inflationary costs, and U.S. commercial investments. With €51.3 million in cash and equivalents and minimal debt, EDAP is positioned to fund further sales, marketing, education, and clinical development initiatives. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallEDAP TMS Q2 202300:00 / 00:00Speed:1x1.25x1.5x2xThere are 7 speakers on the call. Operator00:00:00Greetings and welcome to the EDAP TMS Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to John Francis, Managing Director of LifeSci Advisors. Operator00:00:26Thank you. Please go ahead. Speaker 100:00:29Good morning. Thank you for joining us for the EDAP TMS Q2 2023 financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer Francois Dijk, Chief Financial Officer and Ken Mobek, Chief Financial Officer of the U. S. Subsidiary. Speaker 100:00:45Before 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, 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 Chief Executive Officer, Ryan Rhodes. Ryan? Speaker 200:01:18Thank you, John, and good morning, everyone. I will start today's call by providing highlights from the Q2 of 2023 and then turn the call over to Ken Mobick, our U. S. CFO, who will then present the corresponding details of financial performance. I'm pleased to report that we achieved record 2nd quarter and first half revenues reflecting strong underlying demand for Focal One HIFU technology. Speaker 200:01:452nd quarter revenue of EUR 14,300,000 was predominantly driven by new U. S. Capital placements at leading academic and community hospitals as well as from increased procedure volumes leading to higher disposable sales. We are very encouraged by the higher utilization trends of Focal One HIFU amongst our existing customers, which helped EDAP generate strong year over year HIFU revenue growth of 63.6% for the quarter. There are several factors contributing to increased adoption. Speaker 200:02:21As a reminder, Focal 1 robotic HIFU is a non invasive outpatient procedure that demonstrates excellent oncologic control with minimal patient downtime and does not require use of surgery or radiation. Vocal One continues to demonstrate strong clinical outcomes and favorable economics that are driving both growth and adoption. In fact, Focal 1 is now a leading and prominent focal therapy in 6 out of the 10 best hospitals for urology according to a recent U. S. News and World Report. Speaker 200:03:01Focal One HIFU is also becoming one of the fastest growing treatments within the category of prostate cancer management. Strong Focal 1 Robotic HIFU Capital sales continue to lead our top line performance with sales of 4 Focal 1 units in the U. S, including the first system placements in the states of both Kansas and West Virginia. While we continue to see adoption at leading academic and regional cancer centers, we are also proud to announce the recent sale of Focal One to Memorial Sloan Kettering Cancer Center, which is a top ranked world renowned urology institution. While prominent academic urology focused hospitals continue to be strong proponents of Focal 1 HIFU therapy, community hospitals and large urology practices are increasingly adopting Focal 1 HIFU as a necessary treatment option for their prostate cancer patients. Speaker 200:04:03Procedure growth is also an important metric that we follow closely. As noted, Focal 1 HIFU procedure volumes in the U. S. Experienced robust 85% year over year growth in the Q2. Sequentially, procedure volumes grew 29% in the Q2 of 2023 as compared to the Q1, representing our 3rd consecutive quarter of double digit percentage growth. Speaker 200:04:35We attribute this acceleration in procedure growth to our strategic investments to grow the Focal One clinical sales team combined with improved reimbursement rates. While we continue to see favorable impact on demand for higher reimbursement in the U. S, in July, we were also pleased to announce reimbursement approval in Switzerland for the use of high intensity focused ultrasound in the treatment of prostate cancer having taken effect on July 1, 2023. Switzerland is a member of the DACH region, including Germany, Austria and Switzerland with over 100,000,000 combined total inhabitants. Switzerland has many hospitals ranked amongst the best 250 in the world according to Newsweek's The World's Best Hospitals 2023. Speaker 200:05:31Included in this list is the University of Zurich, an active prominent Focal One site and the leading innovation center for HIFU in the country and a member of the League of European Research Universities placing it among Europe's most prestigious research institutions. We have also made commensurate investments in ongoing educational activities including the live broadcasted Focal 1 procedure performed by Doctor. Andre Abreu and Doctor. Amir Labaci, Assistant Professors of Clinical Urology at the Keck School of Medicine at the University of Southern California, the first institution to acquire and adopt EDAP HIFU technology. In April, we broadcasted this live event worldwide and discussed its success on our last earnings call. Speaker 200:06:24A replay of that procedure is still available to view at our website focalone.com. In April, we had our largest presence ever at the American Urological Association meeting with many productive engagements amongst prominent clinicians, hospital executives and other stakeholders who validated our leading position in the category of focal therapy. As a reminder, there were multiple Focal One scientific abstracts presented by several prestigious institutions including the Martini Clinic in Hamburg, Germany. The Martini Clinic has the largest prostate cancer treatment program in the world. The AUA abstract presented by the Martini Clinic highlighted 7 years experience using Focal 1 high intensity focused ultrasound in 164 patients with prostate cancer. Speaker 200:07:21All treatments were established as primary therapy and monitoring definitions followed a very strict protocol. The oncologic outcome showed excellent cancer control with only 7% significant infield recurrence and 91.5% radical treatment free survival at 7 years. On the functional side, very few complications were reported with 91.5% patients maintaining their baseline urinary incontinence and 85% maintaining their baseline erectile function. These results were impressive as we continue to further educate clinicians, patients and providers on the benefits of Focal One Robotic HIFU. Additionally, throughout the AUA meeting, EDAP was very busy giving numerous customers the hands on ability to use Focal One in a simulated prostate ablation procedure. Speaker 200:08:20They were able to see in action the robotic positioning system, advanced imaging and fusion capabilities while setting up a prescribed ablation treatment plan. More recently Focal One was the only focal therapy invited to present and participate in a plenary panel on innovative robotic systems at the preeminent annual meeting of the Society of Robotic Surgery held in Melbourne, Australia. I'd now like to provide a brief update on our distribution business. As previously announced during the Q1, EDAP received approval from Japan's Pharmaceutical and Medical Devices Agency for commercialization of Exactu Micro Ultrasound, enabling EDAP to emerge as a major player in the prostate cancer market in Japan. Japan remains the 2nd largest market for advanced medical device technology with prostate cancer being the most commonly diagnosed cancer in Japanese men with over 100,000 new prostate cancer diagnosis made annually. Speaker 200:09:28Following this approval, EDAP had a strong presence at the 110th Annual Meeting of the Japanese Urology Association, which showcased and officially launched Exactu Micro Ultrasound in Japan. During the quarter, we sold 9 Exactu units. We continue to see ongoing demand for this differentiated advanced imaging technology that is becoming routinely used in performing targeted biopsies for prostate cancer. In parallel, our Focal 1 HIFU clinical development programs are progressing well. Last quarter, we reported positive results from the EndoHIFU R1 Phase 2 study in deep infiltrating rectal endometriosis where patients treated with Focal 1 HIFU experienced measurable improvement across a broad range of debilitating symptoms. Speaker 200:10:23Following these positive results, we are pleased to report that more than 50% of the patients have now been enrolled across 6 centers in France for our confirmatory Phase 3 comparative double blind randomized controlled trial. As noted, the primary efficacy endpoint for this 60 patient study is a level of acute pelvic pain as assessed at 3 months post procedure. If results from the Phase 3 trial mirror those from the Phase 2 trial, we would possess strong clinical evidence to support Focal 1 HIFU as a new effective, less invasive, first line treatment for deep infiltrating rectal endometriosis. Given how few treatment options are available Focal 1 HIFU could become an important new treatment option enabling patients to avoid the known morbidity and complications often associated with surgical resection of the bowel or rectum. Looking ahead, we expect both growing demand for new Focal 1 HIFU systems as well as increased utilization amongst our existing customers. Speaker 200:11:33With €51,300,000 or US56 $1,000,000 in cash and short term investments and de minimis debt, we remain well positioned to invest in our sales, marketing, education and clinical development activities to support the continued expansion of Focal One HIFU. The strategic and ongoing investments made in the first half of twenty twenty three will support the increased demand in the U. S. Marketplace for our technology. With our growing active pipeline for new business, we anticipate continued strong adoption of Focal One technology platform with respect to new system placements and increasing utilization. Speaker 200:12:20With that, I will now pass the call over to Ken to review the Q2 financial performance. Ken? Thank you, Ryan, 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 1.0871 for the Q2 of 2023. Speaker 200:12:45Total revenue for the Q2 of 2023 was €14,300,000 an increase of almost 1% as compared to total revenue of €14,200,000 for the same period in 2022 and a record level for a Q2. Looking at revenue by division, total revenue in the HIFU business for the Q2 was €4,900,000 as compared to €3,000,000 for the Q2 of 2022, a 63.6% increase year over year. As referenced, the increase was driven by selling 4 Focal One units in the Q2 of 2023 versus 1 unit sold in the Q2 of 2022. Total revenue in the litho business for the Q2 was €2,200,000 as compared to €3,600,000 for the Q2 of 2022. The year over year decline in litho revenue was mainly attributed to 6 less units sold year over year as well as supply chain constraints with a few key suppliers during the quarter. Speaker 200:13:57Total revenue in the distribution business for the Q2 was €7,200,000 as compared to €7,600,000 for the Q2 of 2022. The decline in distribution revenue was primarily driven by 9 ExactView units sold during the Q2 of 2023 as compared to 15 units sold during the Q2 of 2022. Gross profit for the Q2 was €5,700,000 compared to €6,200,000 for the year ago period. Gross profit margin on net sales was 39.6% in the 2nd quarter compared to 43.8% in the year ago period. The decrease in gross profit margin year over year was primarily due to distribution product mix, global inflationary price pressure on components with increased manufacturing costs and continued investments in our U. Speaker 200:14:55S. Service and clinical application organizations to support HIFU and long term revenue growth. Operating expenses were €9,900,000 for the Q2 compared to €6,600,000 for the same period of 2022. The increase in operating expenses was primarily due to the strategic and planned build out of the U. S. Speaker 200:15:19Team and commercial infrastructure, variable compensation and increased marketing activities. Operating loss for the Q2 was €4,200,000 compared to an operating loss of €400,000 in the Q2 of 2022. Excluding the impact of non cash share based compensation, operating loss for the Q2 would have been €3,100,000 compared to an operating loss of €100,000 in Q2 2022. Net loss for the 2nd quarter was €4,700,000 or €0.13 per diluted share as compared to net income of €1,800,000 or €0.05 per diluted share in the year ago period. Total cash and cash equivalents at the end of Q2 was €51,300,000 or €56,000,000 in U. Speaker 200:16:17S. Dollars as compared to €58,300,000 or €63,400,000 in U. S. Dollars at the end of Q1 2023. We continue to monitor cash flow closely as we invest for long term business growth, but also remaining cognizant of short term financial performance. Speaker 200:16:37Through our strategic investments, we are confident in realizing the extraordinary opportunity with Focal One HIFU to fundamentally change the emerging treatment paradigm for the management of prostate cancer. Those are our key financial highlights for the Q2 of 2023. And with that, I'd like to turn the call back to Ryan. Ryan? Thank you, Ken. Speaker 200:17:04In summary, our 2nd quarter results continue to reinforce our confidence in the growing demand for Focal One as well as validating our strategy and execution to drive education and adoption. Sales and unit placements of Focal One are growing along with increased Focal One type of procedures. In closing, we remain optimistic about the remainder of 2023. I would like to thank the entire EDAP team for their dedication and hard work that is driving increased awareness amongst clinicians and patients of Focal One HIFU as an important and growing treatment option for prostate cancer management. We look forward to sharing our progress with you again in the fall. Speaker 200:17:50And I will now turn it back over to the operator for questions. Operator? Operator00:17:56Thank you. The floor is now open for questions. The first question today is coming from Michael Zarcone of Jefferies. Please go ahead. Speaker 300:18:29Good morning and thanks for taking my question. So first one is just on the 4 Focal One system sales in the U. S. I guess, can you just talk more about the sales funnel and how demand is shaping up there? And maybe how you think the trajectory of the system placements might shake out through the remainder of the year? Speaker 200:18:57Yes. So we continue to see our active pipeline growing. As noted, we have added additional headcount. We're building a broader coverage model. And again, our pipeline continues to grow. Speaker 200:19:11We have a number of projects in play and we expect to have notable sales in both Q3 and Q4. So we would say openly the back half of the year should be a stronger portion of the year. So currently, again, we've got our team active. We have some deals in process and we're excited to close out both Q3 and Q4. Speaker 300:19:42Great. Thanks for the color. Maybe just a follow-up on that. If you had about 11 system placements in 1H, just based on your commentary, that means we could see above that for 2H? Speaker 200:19:57Definitely. I would say above that for sure. And again, we continue to grow the commercial structure. And with that, we broadened the number of hospitals, as I would say, in our active pipeline. Speaker 300:20:16That's really helpful. Thanks, Ryan. And then just last one for me. 85% procedure growth in the U. S. Speaker 300:20:23Seems pretty strong. Can you just give a little more color on what you're seeing in terms of the utilization environment, even if it's trends in procedures per system? And then is there any way you can quantify or ballpark the number of procedures you're seeing either quarterly or annualized in the U. S? Speaker 200:20:45Yes, Michael, we don't give out our actual procedure numbers. What I would say is we continue to see increased utilization both in our installed base customers and even new customers that are just acquiring the technology. We track metrics to include time to first case, time from case 1 to case 10 and beyond. So I think we're seeing the impact our clinical sales team is making, but we're also seeing the consumer that is patients looking for other options beyond just surgery and radiation. And again, I think in our message, we have a non invasive treatment option for men diagnosed with prostate cancer. Speaker 200:21:32So we continue to create more market awareness and I think that also will breathe additional momentum into our story. Speaker 300:21:42Great. Thanks so much, Ryan. Speaker 200:21:45Thank you, Michael. Operator00:21:48Thank you. The next question is coming from Frank Tachinan of Lake Street Capital Markets. Please go ahead. Speaker 400:21:54Hey, thanks for taking the questions. I wanted to follow-up just one more question on placement expectations in the second half of the year. Ryan, I was hoping you could comment on regular seasonality trends. I know I asked about this last call, but was looking for just an update if you expect that Q3 being a summer months OUS seasonality more pronounced sometimes U. S. Speaker 400:22:15Seasonality more pronounced as well, with the majority of those greater than 11 implants in the Q4 as an expectation? Speaker 200:22:26Yes, Frank. We don't see, at least as we're going through the quarter, the seasonality we would typically experience in, say, a summer slowdown. We don't see that. I think we see the momentum building. And as mentioned earlier, again, our pipeline continues to develop and grow. Speaker 200:22:45We've got our team head down and focused. And I would expect a stronger second half of the year. And again, so I don't see the slower Q3 that may be common for other companies or other technologies. I think we have that momentum as we walk into the back half of the year. So I think that's where we stand. Speaker 400:23:10Got it. That's helpful. And then on the procedure side, I know one thing you've spoken about in the past is related to the disposable ASP with the renewed reimbursement at the beginning of this year and maybe having a little bit of flexibility to increase that ASP or slowly increase that ASP over a number of years. Can you maybe update us on that dynamic and whether or not you still think there's more room to go on the ASP related disposables? Speaker 200:23:38So great question. I would say, yes, there is an opportunity. And I would say, historically, since I've been in the company, the ASP on procedures has gone up. We continue to look at it closely. We work very closely with our legacy customers and we've had some price increases, notably with certain accounts and continue to see that average call it average sales price per procedure going up. Speaker 200:24:09Now again, we pay close attention to that and we monitor and that also plays true for the new accounts that acquire our technology. So I'd say we would say there's room to grow for sure. And again, I think we enjoy some additional advantages from the reimbursement that's in place. Speaker 400:24:35Got it. That's good color. I'll stop there. Thanks for taking the questions. Speaker 200:24:39Thank you, Frank. Operator00:24:42Thank you. The next question is coming from Jason Bednar of Piper Sandler. Please go ahead. Speaker 500:24:49Hey, good morning. Thanks for taking the questions, guys. I wanted to follow-up just really on the Focal One placements and sorry to ask another one here, but I wanted to check to see just how or whether the rate environment and the broader macro dynamics out there just influencing the attitude of hospitals, both on the large academic side and the community centers. Are your prospects moving forward at the same pace as what you've seen historically? I may know the answer just based on how you responded to Frank's question just there regarding business strength here in the Q3. Speaker 500:25:22But I just wanted to check to see if that's a dynamic at all that's influencing conversations you're having and whether business actually might even be stronger than what you're seeing in the Q3, if not for some of these macro factors? Speaker 200:25:35Yes. I don't we don't see we don't really see any headwinds related to that. I know with interest rates going the direction they're going, we have not seen the impact on that. It's we are in a category of disruptive capital equipment. However, we're also in the category of strategic capital. Speaker 200:25:57So again, hospitals, as you know, routinely buy capital equipment. But again, adding Focal 1 and adding Focal Therapy or in our case, robotic Focal HIFU, we see it as a strategic initiative and we work very closely with our hospital customers as we move through that buying process. So again, I don't put us in the category of operational capital. We are strategic capital. And again, you can back it up in the state of, hey, it's clinically necessary to offer something today, we believe in focal therapy. Speaker 200:26:34It's also strategic for a hospital and it can bring strong economic reward. So we have that in our narrative. Yes. Jason, the only other thing I'd add regarding your question is we have seen in the hospital environment and the purchase environment, they're taking time in approving their purchases, okay. We had a few systems get stuck in the buying process in Q2. Speaker 200:27:03We see going through in Q3. So if anything, they're just taking a really good look at these purchases before they buy them. Speaker 500:27:11Okay. So maybe just a longer sales cycle, but not actually influencing the yes or no decision? Exactly. Perfect. Okay. Speaker 500:27:20That's very helpful. I also wanted to ask Ken on the gross margins. They're a little bit below what we were looking for. I know you called out some of the factors that were influencing some of that softness. But maybe if you can just add any more color on the distribution side that was probably the bigger miss in our model. Speaker 500:27:41But then any other directional guidance you can give? I know you don't offer formal guidance, but any color on how to think about whether it's segment or company wide gross margins going forward and whether we're at a trough here or if we need to contemplate additional service investments that may still then weigh on those gross margins going forward? Speaker 200:28:02Yes. So good question, Jason. The one big thing was our distribution mix this quarter. So I look at that as kind of timing related. We're always going to continue to make investments to grow the company forward. Speaker 200:28:21Our operating expenses are continued to grow, but we're monitoring them closely, right. We really need to invest in areas that's really going to drive the sales funnel. So as well as on the COGS line, we've got to build some support to get the tools installed and service as well. We did see a little bit of inflationary price pressures that we're going to that we're monitoring. Obviously, we're looking at solutions to that. Speaker 200:28:52And then just going forward, I do see when the mix gets stronger, as Ryan noted, we do expect Focal 1 to pick up here in the second half. And then as we noted earlier in the year too, we increased our prices as well, our list prices for Focal 1. So I do see margins picking back up versus where they ended up in Q2. Speaker 400:29:19All Speaker 500:29:20right. Very helpful. Thanks so much. Speaker 400:29:23Thank you. Operator00:29:25Thank you. The next question is coming from Swayampakula Ramakanth of H. C. Wainwright. Please go ahead. Speaker 600:29:33Thank you. This is RK from H. C. Wainwright. Good morning, folks. Speaker 600:29:42With increasing volume growth, as you stated, about 85% year over year and 29% quarter over quarter, when would we when would you expect this to be reflected in your consumables revenue growth? Just trying to get an idea in terms of the cadence of that revenue flow. Speaker 200:30:09Yes, RK. First thing, again, we build programs. So when the system is placed, there's a training event for the team. We call it an onboarding process. And so that can take some time. Speaker 200:30:25It really depends on each hospital, their individual. But we do everything to shorten that timeline. So I think when we'll see more of a notable impact over time is certainly as we place more systems, but also as systems get used to using the technology and have clinical use and patients treated clinically and successfully, I think just organically you're going to see an increase in same store sales. And we have a dedicated team, both clinical sales team and applications team that work very closely with our customers. So I think as you look outward, it takes a while, but notably based on percentage increase, we see an increase of procedures and that is both in our legacy accounts as well as we are placing more systems. Speaker 200:31:21So I think over time that'll be something to look closer at. And again, we are very focused on our procedures as noted and we continue to resource that team accordingly. Speaker 600:31:37Thank you. Just trying to get an additional color on the sales cycle timing. With reimbursement in place and you stated in an answer to the previous question that the sales cycle is becoming a little bit longer because we're trying to take a closer look. Any additional color why that is so? Is that more on the financing side of things? Speaker 600:32:08Or I'm just trying to understand what is making that sales cycle longer? Is that more administrative stuff? Anything at all? Speaker 200:32:21Yes. It'd be fair to say today, hospitals that are looking at making investments in new innovative capital equipment, they typically go through their own pro form a analysis. So those pro form a analysis vary by institution. And some institutions move faster than others, some may slow down, they just want to do their due diligence. And again, we're adding in many cases, it's a new revenue enhancing service line. Speaker 200:32:51And with that said, they just want to look at the numbers and run some calculations. As we have said in the past, we have favorable economics. And typically, when we go through that process, it leads ultimately to a sale. So again, I think it varies by institution and as Ken had referenced, And it's not for every hospital. I think some will always move faster than others. Speaker 200:33:21But we're accustomed to going through that process and we pay a lot of attention to it. If it slows down, we're active with our customers kind of working shoulder to shoulder to make sure we answer any questions they have or we can help them fully appreciate and understand the financial return from their investment. Speaker 600:33:43Thanks for that. And then on the Swiss reimbursement, with that in place, how long do you think it could take for it to reflect on your sales? And how big is the Swiss market or Swiss or associated countries along with Swiss? Speaker 200:34:04So as noted, we first off, Switzerland is a country with essentially three languages, right? You have the German side, Zurich and the Cantons, you have the French side and then you even have an area of Italian influence. And so I think back to the reimbursement, we've been active in Switzerland over the years. As mentioned, we have a very prominent program at University of Zurich with Professor Daniel Everly. And we have had some we have other systems placed in the Geneva market, etcetera. Speaker 200:34:44So to really say how big the market is, I mean, there's a handful of hospitals that are well known and prominent and some of those we're actively working with. I can't give you a hard number, but I would say this, our sales teams are active in the market. We know our customer base, both the legacy base and our target customers and we're resourced well to go after that business. And I'm excited. I think this is notable in a country that is small. Speaker 200:35:15Switzerland is not a big country, but a country that has influence in Europe. Speaker 600:35:23So last question from me. On the litho business, you stated there was some supply chain issues. Is that pretty much limited to the litho business or can it bleed into other divisions as well? And how long do you think the supply chain issue would last within the Litto business? Speaker 200:35:48Yes. So the supply chain is and it's not so much related to us. It's the componentry that they would bring together or purchase alongside of our proprietary lithotripsy technologies. So I don't think it's a long term thing. In fact, we those sales are just delayed until they have the ability to purchase the other components that work alongside our lithotripsy technology. Speaker 200:36:18So and I don't see really any spillover into any other areas of our business today as stated today. So again, I think it just we had some sales that were ready, but they need to get the additional components added as noted. And we don't see any impact in our other distribution business at this point. Speaker 600:36:45Thank you. Thank you, Ryan, for taking all my questions. I appreciate it. Speaker 200:36:48Thank you, RK. Operator00:36:51Thank you. At this time, I'd like to turn the floor back over to Mr. Rhodes for closing comments. Speaker 200:36:58I want to thank all who participated in today's call. As a reminder, we will be presenting in New York at both the Morgan Stanley and H. C. Wainwright Investment Conferences in September. In November, we plan to participate in the Jefferies Global Healthcare Conference in London and we look forward to speaking to all of you again in November on our Q3 earnings. Speaker 200:37:24Thank you. Operator00:37:27Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines or log off the webcast at this time and enjoy the rest of your day.Read morePowered by Earnings DocumentsPress Release(8-K) EDAP TMS Earnings HeadlinesEdap Tms (NASDAQ:EDAP) & Precision Optics (NASDAQ:POCI) Head to Head SurveyJune 16, 2025 | americanbankingnews.comEDAP TMS at Jefferies Conference: Strategic Shift to HIFU TherapyJune 7, 2025 | investing.comThe lost Steve Jobs project that could save TeslaDid Steve Jobs Leave Behind a $25 Trillion Gift for America? In his final years, America's greatest innovator worked on a secretive project beyond Apple's walls— a vision he believed would transform our nation's economy and restore its global leadership. Insiders called it "extraordinary" and "a model for improving America." On July 21st, this hidden legacy could finally be revealed, unlocking what CNBC calls a "$25 trillion opportunity" for generations to come.June 22, 2025 | InvestorPlace (Ad)edap tms sa announces shareholder meeting for june 2025June 5, 2025 | investing.comEDAP to Present at the Jefferies Global Healthcare ConferenceMay 27, 2025 | globenewswire.comEDAP TMS S.A. (NASDAQ:EDAP) Just Reported And Analysts Have Been Cutting Their EstimatesMay 18, 2025 | finance.yahoo.comSee More EDAP TMS Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like EDAP TMS? Sign up for Earnings360's daily newsletter to receive timely earnings updates on EDAP TMS and other key companies, straight to your email. Email Address About EDAP TMSEDAP TMS (NASDAQ:EDAP) SA is a holding company, which, through its subsidiary, engages in the development, production, and marketing of minimally invasive medical devices for urological diseases. It operates through the High Intensity Focused Ultrasound (HIFU) and Urology Devices and Services (UDS) segments. The HIFU segment develops, manufactures, and markets devices for the minimally invasive ablation of certain types of localized tumors using HIFU technology. The UDS segment focuses on the development, marketing, manufacturing, and servicing of medical devices for the minimally invasive diagnosis or treatment of urological disorders, mainly urinary stones, and other clinical indications. The company was founded on December 3, 1979 and is headquartered in Vaulx-en-Velin, France.View EDAP TMS ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Smith & Wesson Stock Falls on Earnings Miss, Tariff WoesBroadcom Slides on Solid Earnings, AI Outlook Still StrongFive Below Pops on Strong Earnings, But Rally May StallRed Robin's Comeback: Q1 Earnings Spark Investor HopesOllie’s Q1 Earnings: The Good, the Bad, and What’s NextBroadcom Earnings Preview: AVGO Stock Near Record HighsUlta’s Beautiful Q1 Earnings Report Points to More Gains Ahead Upcoming Earnings FedEx (6/24/2025)Micron Technology (6/25/2025)Paychex (6/25/2025)NIKE (6/26/2025)Bank of America (7/14/2025)Wells Fargo & Company (7/14/2025)JPMorgan Chase & Co. 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There are 7 speakers on the call. Operator00:00:00Greetings and welcome to the EDAP TMS Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to John Francis, Managing Director of LifeSci Advisors. Operator00:00:26Thank you. Please go ahead. Speaker 100:00:29Good morning. Thank you for joining us for the EDAP TMS Q2 2023 financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer Francois Dijk, Chief Financial Officer and Ken Mobek, Chief Financial Officer of the U. S. Subsidiary. Speaker 100:00:45Before 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, 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 Chief Executive Officer, Ryan Rhodes. Ryan? Speaker 200:01:18Thank you, John, and good morning, everyone. I will start today's call by providing highlights from the Q2 of 2023 and then turn the call over to Ken Mobick, our U. S. CFO, who will then present the corresponding details of financial performance. I'm pleased to report that we achieved record 2nd quarter and first half revenues reflecting strong underlying demand for Focal One HIFU technology. Speaker 200:01:452nd quarter revenue of EUR 14,300,000 was predominantly driven by new U. S. Capital placements at leading academic and community hospitals as well as from increased procedure volumes leading to higher disposable sales. We are very encouraged by the higher utilization trends of Focal One HIFU amongst our existing customers, which helped EDAP generate strong year over year HIFU revenue growth of 63.6% for the quarter. There are several factors contributing to increased adoption. Speaker 200:02:21As a reminder, Focal 1 robotic HIFU is a non invasive outpatient procedure that demonstrates excellent oncologic control with minimal patient downtime and does not require use of surgery or radiation. Vocal One continues to demonstrate strong clinical outcomes and favorable economics that are driving both growth and adoption. In fact, Focal 1 is now a leading and prominent focal therapy in 6 out of the 10 best hospitals for urology according to a recent U. S. News and World Report. Speaker 200:03:01Focal One HIFU is also becoming one of the fastest growing treatments within the category of prostate cancer management. Strong Focal 1 Robotic HIFU Capital sales continue to lead our top line performance with sales of 4 Focal 1 units in the U. S, including the first system placements in the states of both Kansas and West Virginia. While we continue to see adoption at leading academic and regional cancer centers, we are also proud to announce the recent sale of Focal One to Memorial Sloan Kettering Cancer Center, which is a top ranked world renowned urology institution. While prominent academic urology focused hospitals continue to be strong proponents of Focal 1 HIFU therapy, community hospitals and large urology practices are increasingly adopting Focal 1 HIFU as a necessary treatment option for their prostate cancer patients. Speaker 200:04:03Procedure growth is also an important metric that we follow closely. As noted, Focal 1 HIFU procedure volumes in the U. S. Experienced robust 85% year over year growth in the Q2. Sequentially, procedure volumes grew 29% in the Q2 of 2023 as compared to the Q1, representing our 3rd consecutive quarter of double digit percentage growth. Speaker 200:04:35We attribute this acceleration in procedure growth to our strategic investments to grow the Focal One clinical sales team combined with improved reimbursement rates. While we continue to see favorable impact on demand for higher reimbursement in the U. S, in July, we were also pleased to announce reimbursement approval in Switzerland for the use of high intensity focused ultrasound in the treatment of prostate cancer having taken effect on July 1, 2023. Switzerland is a member of the DACH region, including Germany, Austria and Switzerland with over 100,000,000 combined total inhabitants. Switzerland has many hospitals ranked amongst the best 250 in the world according to Newsweek's The World's Best Hospitals 2023. Speaker 200:05:31Included in this list is the University of Zurich, an active prominent Focal One site and the leading innovation center for HIFU in the country and a member of the League of European Research Universities placing it among Europe's most prestigious research institutions. We have also made commensurate investments in ongoing educational activities including the live broadcasted Focal 1 procedure performed by Doctor. Andre Abreu and Doctor. Amir Labaci, Assistant Professors of Clinical Urology at the Keck School of Medicine at the University of Southern California, the first institution to acquire and adopt EDAP HIFU technology. In April, we broadcasted this live event worldwide and discussed its success on our last earnings call. Speaker 200:06:24A replay of that procedure is still available to view at our website focalone.com. In April, we had our largest presence ever at the American Urological Association meeting with many productive engagements amongst prominent clinicians, hospital executives and other stakeholders who validated our leading position in the category of focal therapy. As a reminder, there were multiple Focal One scientific abstracts presented by several prestigious institutions including the Martini Clinic in Hamburg, Germany. The Martini Clinic has the largest prostate cancer treatment program in the world. The AUA abstract presented by the Martini Clinic highlighted 7 years experience using Focal 1 high intensity focused ultrasound in 164 patients with prostate cancer. Speaker 200:07:21All treatments were established as primary therapy and monitoring definitions followed a very strict protocol. The oncologic outcome showed excellent cancer control with only 7% significant infield recurrence and 91.5% radical treatment free survival at 7 years. On the functional side, very few complications were reported with 91.5% patients maintaining their baseline urinary incontinence and 85% maintaining their baseline erectile function. These results were impressive as we continue to further educate clinicians, patients and providers on the benefits of Focal One Robotic HIFU. Additionally, throughout the AUA meeting, EDAP was very busy giving numerous customers the hands on ability to use Focal One in a simulated prostate ablation procedure. Speaker 200:08:20They were able to see in action the robotic positioning system, advanced imaging and fusion capabilities while setting up a prescribed ablation treatment plan. More recently Focal One was the only focal therapy invited to present and participate in a plenary panel on innovative robotic systems at the preeminent annual meeting of the Society of Robotic Surgery held in Melbourne, Australia. I'd now like to provide a brief update on our distribution business. As previously announced during the Q1, EDAP received approval from Japan's Pharmaceutical and Medical Devices Agency for commercialization of Exactu Micro Ultrasound, enabling EDAP to emerge as a major player in the prostate cancer market in Japan. Japan remains the 2nd largest market for advanced medical device technology with prostate cancer being the most commonly diagnosed cancer in Japanese men with over 100,000 new prostate cancer diagnosis made annually. Speaker 200:09:28Following this approval, EDAP had a strong presence at the 110th Annual Meeting of the Japanese Urology Association, which showcased and officially launched Exactu Micro Ultrasound in Japan. During the quarter, we sold 9 Exactu units. We continue to see ongoing demand for this differentiated advanced imaging technology that is becoming routinely used in performing targeted biopsies for prostate cancer. In parallel, our Focal 1 HIFU clinical development programs are progressing well. Last quarter, we reported positive results from the EndoHIFU R1 Phase 2 study in deep infiltrating rectal endometriosis where patients treated with Focal 1 HIFU experienced measurable improvement across a broad range of debilitating symptoms. Speaker 200:10:23Following these positive results, we are pleased to report that more than 50% of the patients have now been enrolled across 6 centers in France for our confirmatory Phase 3 comparative double blind randomized controlled trial. As noted, the primary efficacy endpoint for this 60 patient study is a level of acute pelvic pain as assessed at 3 months post procedure. If results from the Phase 3 trial mirror those from the Phase 2 trial, we would possess strong clinical evidence to support Focal 1 HIFU as a new effective, less invasive, first line treatment for deep infiltrating rectal endometriosis. Given how few treatment options are available Focal 1 HIFU could become an important new treatment option enabling patients to avoid the known morbidity and complications often associated with surgical resection of the bowel or rectum. Looking ahead, we expect both growing demand for new Focal 1 HIFU systems as well as increased utilization amongst our existing customers. Speaker 200:11:33With €51,300,000 or US56 $1,000,000 in cash and short term investments and de minimis debt, we remain well positioned to invest in our sales, marketing, education and clinical development activities to support the continued expansion of Focal One HIFU. The strategic and ongoing investments made in the first half of twenty twenty three will support the increased demand in the U. S. Marketplace for our technology. With our growing active pipeline for new business, we anticipate continued strong adoption of Focal One technology platform with respect to new system placements and increasing utilization. Speaker 200:12:20With that, I will now pass the call over to Ken to review the Q2 financial performance. Ken? Thank you, Ryan, 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 1.0871 for the Q2 of 2023. Speaker 200:12:45Total revenue for the Q2 of 2023 was €14,300,000 an increase of almost 1% as compared to total revenue of €14,200,000 for the same period in 2022 and a record level for a Q2. Looking at revenue by division, total revenue in the HIFU business for the Q2 was €4,900,000 as compared to €3,000,000 for the Q2 of 2022, a 63.6% increase year over year. As referenced, the increase was driven by selling 4 Focal One units in the Q2 of 2023 versus 1 unit sold in the Q2 of 2022. Total revenue in the litho business for the Q2 was €2,200,000 as compared to €3,600,000 for the Q2 of 2022. The year over year decline in litho revenue was mainly attributed to 6 less units sold year over year as well as supply chain constraints with a few key suppliers during the quarter. Speaker 200:13:57Total revenue in the distribution business for the Q2 was €7,200,000 as compared to €7,600,000 for the Q2 of 2022. The decline in distribution revenue was primarily driven by 9 ExactView units sold during the Q2 of 2023 as compared to 15 units sold during the Q2 of 2022. Gross profit for the Q2 was €5,700,000 compared to €6,200,000 for the year ago period. Gross profit margin on net sales was 39.6% in the 2nd quarter compared to 43.8% in the year ago period. The decrease in gross profit margin year over year was primarily due to distribution product mix, global inflationary price pressure on components with increased manufacturing costs and continued investments in our U. Speaker 200:14:55S. Service and clinical application organizations to support HIFU and long term revenue growth. Operating expenses were €9,900,000 for the Q2 compared to €6,600,000 for the same period of 2022. The increase in operating expenses was primarily due to the strategic and planned build out of the U. S. Speaker 200:15:19Team and commercial infrastructure, variable compensation and increased marketing activities. Operating loss for the Q2 was €4,200,000 compared to an operating loss of €400,000 in the Q2 of 2022. Excluding the impact of non cash share based compensation, operating loss for the Q2 would have been €3,100,000 compared to an operating loss of €100,000 in Q2 2022. Net loss for the 2nd quarter was €4,700,000 or €0.13 per diluted share as compared to net income of €1,800,000 or €0.05 per diluted share in the year ago period. Total cash and cash equivalents at the end of Q2 was €51,300,000 or €56,000,000 in U. Speaker 200:16:17S. Dollars as compared to €58,300,000 or €63,400,000 in U. S. Dollars at the end of Q1 2023. We continue to monitor cash flow closely as we invest for long term business growth, but also remaining cognizant of short term financial performance. Speaker 200:16:37Through our strategic investments, we are confident in realizing the extraordinary opportunity with Focal One HIFU to fundamentally change the emerging treatment paradigm for the management of prostate cancer. Those are our key financial highlights for the Q2 of 2023. And with that, I'd like to turn the call back to Ryan. Ryan? Thank you, Ken. Speaker 200:17:04In summary, our 2nd quarter results continue to reinforce our confidence in the growing demand for Focal One as well as validating our strategy and execution to drive education and adoption. Sales and unit placements of Focal One are growing along with increased Focal One type of procedures. In closing, we remain optimistic about the remainder of 2023. I would like to thank the entire EDAP team for their dedication and hard work that is driving increased awareness amongst clinicians and patients of Focal One HIFU as an important and growing treatment option for prostate cancer management. We look forward to sharing our progress with you again in the fall. Speaker 200:17:50And I will now turn it back over to the operator for questions. Operator? Operator00:17:56Thank you. The floor is now open for questions. The first question today is coming from Michael Zarcone of Jefferies. Please go ahead. Speaker 300:18:29Good morning and thanks for taking my question. So first one is just on the 4 Focal One system sales in the U. S. I guess, can you just talk more about the sales funnel and how demand is shaping up there? And maybe how you think the trajectory of the system placements might shake out through the remainder of the year? Speaker 200:18:57Yes. So we continue to see our active pipeline growing. As noted, we have added additional headcount. We're building a broader coverage model. And again, our pipeline continues to grow. Speaker 200:19:11We have a number of projects in play and we expect to have notable sales in both Q3 and Q4. So we would say openly the back half of the year should be a stronger portion of the year. So currently, again, we've got our team active. We have some deals in process and we're excited to close out both Q3 and Q4. Speaker 300:19:42Great. Thanks for the color. Maybe just a follow-up on that. If you had about 11 system placements in 1H, just based on your commentary, that means we could see above that for 2H? Speaker 200:19:57Definitely. I would say above that for sure. And again, we continue to grow the commercial structure. And with that, we broadened the number of hospitals, as I would say, in our active pipeline. Speaker 300:20:16That's really helpful. Thanks, Ryan. And then just last one for me. 85% procedure growth in the U. S. Speaker 300:20:23Seems pretty strong. Can you just give a little more color on what you're seeing in terms of the utilization environment, even if it's trends in procedures per system? And then is there any way you can quantify or ballpark the number of procedures you're seeing either quarterly or annualized in the U. S? Speaker 200:20:45Yes, Michael, we don't give out our actual procedure numbers. What I would say is we continue to see increased utilization both in our installed base customers and even new customers that are just acquiring the technology. We track metrics to include time to first case, time from case 1 to case 10 and beyond. So I think we're seeing the impact our clinical sales team is making, but we're also seeing the consumer that is patients looking for other options beyond just surgery and radiation. And again, I think in our message, we have a non invasive treatment option for men diagnosed with prostate cancer. Speaker 200:21:32So we continue to create more market awareness and I think that also will breathe additional momentum into our story. Speaker 300:21:42Great. Thanks so much, Ryan. Speaker 200:21:45Thank you, Michael. Operator00:21:48Thank you. The next question is coming from Frank Tachinan of Lake Street Capital Markets. Please go ahead. Speaker 400:21:54Hey, thanks for taking the questions. I wanted to follow-up just one more question on placement expectations in the second half of the year. Ryan, I was hoping you could comment on regular seasonality trends. I know I asked about this last call, but was looking for just an update if you expect that Q3 being a summer months OUS seasonality more pronounced sometimes U. S. Speaker 400:22:15Seasonality more pronounced as well, with the majority of those greater than 11 implants in the Q4 as an expectation? Speaker 200:22:26Yes, Frank. We don't see, at least as we're going through the quarter, the seasonality we would typically experience in, say, a summer slowdown. We don't see that. I think we see the momentum building. And as mentioned earlier, again, our pipeline continues to develop and grow. Speaker 200:22:45We've got our team head down and focused. And I would expect a stronger second half of the year. And again, so I don't see the slower Q3 that may be common for other companies or other technologies. I think we have that momentum as we walk into the back half of the year. So I think that's where we stand. Speaker 400:23:10Got it. That's helpful. And then on the procedure side, I know one thing you've spoken about in the past is related to the disposable ASP with the renewed reimbursement at the beginning of this year and maybe having a little bit of flexibility to increase that ASP or slowly increase that ASP over a number of years. Can you maybe update us on that dynamic and whether or not you still think there's more room to go on the ASP related disposables? Speaker 200:23:38So great question. I would say, yes, there is an opportunity. And I would say, historically, since I've been in the company, the ASP on procedures has gone up. We continue to look at it closely. We work very closely with our legacy customers and we've had some price increases, notably with certain accounts and continue to see that average call it average sales price per procedure going up. Speaker 200:24:09Now again, we pay close attention to that and we monitor and that also plays true for the new accounts that acquire our technology. So I'd say we would say there's room to grow for sure. And again, I think we enjoy some additional advantages from the reimbursement that's in place. Speaker 400:24:35Got it. That's good color. I'll stop there. Thanks for taking the questions. Speaker 200:24:39Thank you, Frank. Operator00:24:42Thank you. The next question is coming from Jason Bednar of Piper Sandler. Please go ahead. Speaker 500:24:49Hey, good morning. Thanks for taking the questions, guys. I wanted to follow-up just really on the Focal One placements and sorry to ask another one here, but I wanted to check to see just how or whether the rate environment and the broader macro dynamics out there just influencing the attitude of hospitals, both on the large academic side and the community centers. Are your prospects moving forward at the same pace as what you've seen historically? I may know the answer just based on how you responded to Frank's question just there regarding business strength here in the Q3. Speaker 500:25:22But I just wanted to check to see if that's a dynamic at all that's influencing conversations you're having and whether business actually might even be stronger than what you're seeing in the Q3, if not for some of these macro factors? Speaker 200:25:35Yes. I don't we don't see we don't really see any headwinds related to that. I know with interest rates going the direction they're going, we have not seen the impact on that. It's we are in a category of disruptive capital equipment. However, we're also in the category of strategic capital. Speaker 200:25:57So again, hospitals, as you know, routinely buy capital equipment. But again, adding Focal 1 and adding Focal Therapy or in our case, robotic Focal HIFU, we see it as a strategic initiative and we work very closely with our hospital customers as we move through that buying process. So again, I don't put us in the category of operational capital. We are strategic capital. And again, you can back it up in the state of, hey, it's clinically necessary to offer something today, we believe in focal therapy. Speaker 200:26:34It's also strategic for a hospital and it can bring strong economic reward. So we have that in our narrative. Yes. Jason, the only other thing I'd add regarding your question is we have seen in the hospital environment and the purchase environment, they're taking time in approving their purchases, okay. We had a few systems get stuck in the buying process in Q2. Speaker 200:27:03We see going through in Q3. So if anything, they're just taking a really good look at these purchases before they buy them. Speaker 500:27:11Okay. So maybe just a longer sales cycle, but not actually influencing the yes or no decision? Exactly. Perfect. Okay. Speaker 500:27:20That's very helpful. I also wanted to ask Ken on the gross margins. They're a little bit below what we were looking for. I know you called out some of the factors that were influencing some of that softness. But maybe if you can just add any more color on the distribution side that was probably the bigger miss in our model. Speaker 500:27:41But then any other directional guidance you can give? I know you don't offer formal guidance, but any color on how to think about whether it's segment or company wide gross margins going forward and whether we're at a trough here or if we need to contemplate additional service investments that may still then weigh on those gross margins going forward? Speaker 200:28:02Yes. So good question, Jason. The one big thing was our distribution mix this quarter. So I look at that as kind of timing related. We're always going to continue to make investments to grow the company forward. Speaker 200:28:21Our operating expenses are continued to grow, but we're monitoring them closely, right. We really need to invest in areas that's really going to drive the sales funnel. So as well as on the COGS line, we've got to build some support to get the tools installed and service as well. We did see a little bit of inflationary price pressures that we're going to that we're monitoring. Obviously, we're looking at solutions to that. Speaker 200:28:52And then just going forward, I do see when the mix gets stronger, as Ryan noted, we do expect Focal 1 to pick up here in the second half. And then as we noted earlier in the year too, we increased our prices as well, our list prices for Focal 1. So I do see margins picking back up versus where they ended up in Q2. Speaker 400:29:19All Speaker 500:29:20right. Very helpful. Thanks so much. Speaker 400:29:23Thank you. Operator00:29:25Thank you. The next question is coming from Swayampakula Ramakanth of H. C. Wainwright. Please go ahead. Speaker 600:29:33Thank you. This is RK from H. C. Wainwright. Good morning, folks. Speaker 600:29:42With increasing volume growth, as you stated, about 85% year over year and 29% quarter over quarter, when would we when would you expect this to be reflected in your consumables revenue growth? Just trying to get an idea in terms of the cadence of that revenue flow. Speaker 200:30:09Yes, RK. First thing, again, we build programs. So when the system is placed, there's a training event for the team. We call it an onboarding process. And so that can take some time. Speaker 200:30:25It really depends on each hospital, their individual. But we do everything to shorten that timeline. So I think when we'll see more of a notable impact over time is certainly as we place more systems, but also as systems get used to using the technology and have clinical use and patients treated clinically and successfully, I think just organically you're going to see an increase in same store sales. And we have a dedicated team, both clinical sales team and applications team that work very closely with our customers. So I think as you look outward, it takes a while, but notably based on percentage increase, we see an increase of procedures and that is both in our legacy accounts as well as we are placing more systems. Speaker 200:31:21So I think over time that'll be something to look closer at. And again, we are very focused on our procedures as noted and we continue to resource that team accordingly. Speaker 600:31:37Thank you. Just trying to get an additional color on the sales cycle timing. With reimbursement in place and you stated in an answer to the previous question that the sales cycle is becoming a little bit longer because we're trying to take a closer look. Any additional color why that is so? Is that more on the financing side of things? Speaker 600:32:08Or I'm just trying to understand what is making that sales cycle longer? Is that more administrative stuff? Anything at all? Speaker 200:32:21Yes. It'd be fair to say today, hospitals that are looking at making investments in new innovative capital equipment, they typically go through their own pro form a analysis. So those pro form a analysis vary by institution. And some institutions move faster than others, some may slow down, they just want to do their due diligence. And again, we're adding in many cases, it's a new revenue enhancing service line. Speaker 200:32:51And with that said, they just want to look at the numbers and run some calculations. As we have said in the past, we have favorable economics. And typically, when we go through that process, it leads ultimately to a sale. So again, I think it varies by institution and as Ken had referenced, And it's not for every hospital. I think some will always move faster than others. Speaker 200:33:21But we're accustomed to going through that process and we pay a lot of attention to it. If it slows down, we're active with our customers kind of working shoulder to shoulder to make sure we answer any questions they have or we can help them fully appreciate and understand the financial return from their investment. Speaker 600:33:43Thanks for that. And then on the Swiss reimbursement, with that in place, how long do you think it could take for it to reflect on your sales? And how big is the Swiss market or Swiss or associated countries along with Swiss? Speaker 200:34:04So as noted, we first off, Switzerland is a country with essentially three languages, right? You have the German side, Zurich and the Cantons, you have the French side and then you even have an area of Italian influence. And so I think back to the reimbursement, we've been active in Switzerland over the years. As mentioned, we have a very prominent program at University of Zurich with Professor Daniel Everly. And we have had some we have other systems placed in the Geneva market, etcetera. Speaker 200:34:44So to really say how big the market is, I mean, there's a handful of hospitals that are well known and prominent and some of those we're actively working with. I can't give you a hard number, but I would say this, our sales teams are active in the market. We know our customer base, both the legacy base and our target customers and we're resourced well to go after that business. And I'm excited. I think this is notable in a country that is small. Speaker 200:35:15Switzerland is not a big country, but a country that has influence in Europe. Speaker 600:35:23So last question from me. On the litho business, you stated there was some supply chain issues. Is that pretty much limited to the litho business or can it bleed into other divisions as well? And how long do you think the supply chain issue would last within the Litto business? Speaker 200:35:48Yes. So the supply chain is and it's not so much related to us. It's the componentry that they would bring together or purchase alongside of our proprietary lithotripsy technologies. So I don't think it's a long term thing. In fact, we those sales are just delayed until they have the ability to purchase the other components that work alongside our lithotripsy technology. Speaker 200:36:18So and I don't see really any spillover into any other areas of our business today as stated today. So again, I think it just we had some sales that were ready, but they need to get the additional components added as noted. And we don't see any impact in our other distribution business at this point. Speaker 600:36:45Thank you. Thank you, Ryan, for taking all my questions. I appreciate it. Speaker 200:36:48Thank you, RK. Operator00:36:51Thank you. At this time, I'd like to turn the floor back over to Mr. Rhodes for closing comments. Speaker 200:36:58I want to thank all who participated in today's call. As a reminder, we will be presenting in New York at both the Morgan Stanley and H. C. Wainwright Investment Conferences in September. In November, we plan to participate in the Jefferies Global Healthcare Conference in London and we look forward to speaking to all of you again in November on our Q3 earnings. Speaker 200:37:24Thank you. Operator00:37:27Ladies and gentlemen, thank you for your participation. This concludes today's event. 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