EDAP TMS S.A.

Good day, everyone, and welcome to today's EDAP second quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star 1 on your telephone keypad. Please note this call is being recorded. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to John Francis with LifeSci Advisors. Please go ahead.

Good morning. Thank you for joining us for the EDAP TMS Second Quarter 2025 Financial and Operating Results Conference Call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, Ken Movick, Chief Financial Officer, and Francois Dietsch, Chief Accounting Officer. Before we begin, I would like to remind everyone that management's remarks may contain forward-looking statements. which include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. I would now like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes. Ryan?

Thank you, John, and good morning, everyone. As we will review today, ADAPT Focal 1 HIFU remains instrumental in driving the execution of our defined growth strategy. In Q2, we experienced strong and accelerating demand for Focal 1 robotic HIFU. We reported global HIFU revenues of $9.7 million U.S. dollars, up 89% on a year-over-year basis. This increase was driven by the net placement of 12 focal one systems representing a year-over-year growth of 140% as compared to the second quarter of 2024. The 12 system placements comprised of nine capital sales, including one conversion of an operating lease to a capital sale at Kaiser Permanente, as well as operating leases at four large hospital systems. We are encouraged to see hospital networks from our current installed base such as Hackensack Meridian Health, Baptist Health, and New York Presbyterian Health purchase a second focal one system to support the expansion of their focal therapy program across multiple locations. Additionally, we are also proud to report that we now have a total of four focal one placements in Cleveland Clinic facilities worldwide. These include Cleveland Clinic Ohio, Cleveland Clinic Abu Dhabi in the United Arab Emirates, Cleveland Clinic London in the United Kingdom, and Cleveland Clinic Indian River in eastern Florida. We believe our strong second quarter HIFU performance represents a significant inflection point of accelerating growth of FOCAL1 and signals the potential of a broader adoption of focal therapy by community-based urology practices. Based on our most recent assessment of the market, we believe this accelerating growth is driven by three main factors. First and foremost, increased demand for FOC1 is being driven by new, rigorous scientific clinical data supporting HIFU and focal therapy in the treatment of prostate cancer. The groundbreaking HIFI study, which was recently published in European Urology, coupled with level one data from the randomized controlled FARP, or F-A-R-P study, presented at this year's American Urological Association annual meeting, are both helping to build an increased awareness around focal one robotic HIFU. Secondly, our reputation as the premier technology leader in focal therapy continues to grow. First introduced at this year's EAU and AUA meetings, the new focal one eye has been actively embraced by more and more urologists. The groundbreaking new features and design of the Focal One Eye are based directly on feedback from our customers, as well as anticipating the future needs of physicians performing focal therapy. We've incorporated the latest diagnostic imaging modalities and intelligent algorithms, enabling us to further personalize Focal One robotic HIFU procedures. In addition, we believe Focal One Eye's digital interface and fully robotic HIFU energy deliveries designed as uniquely suited to enable remote proctoring and remote collaborative procedures, as demonstrated by a recent collaborative activity across multiple Cleveland Clinic sites. As adoption of focal therapy continues to grow, we believe urologists are looking for the most advanced and capable technology to support their practice. The Focal-1i provides clear and compelling strategic value, not only within the urology suite, but also for hospitals that seek to offer the most advanced cancer treatment approaches to their patients. We are proud to announce that the first Focal-1i system has already been delivered in the U.S. during the second quarter and has successfully performed several procedures to date. Finally, we see an increasing number of patients becoming aware of the benefits of Focal-1. and are weighing their treatment decisions accordingly with further dry urologist interest in adopting our FOCA-1 HIFU platform. It is clear that patients want to access a non-invasive treatment option that can safely target their cancer while also enabling them to maintain their sexual function and urinary continence as compared to whole-gland radical treatment options such as surgery and radiation. During the second quarter, U.S. procedures grew approximately 4.8% over the second quarter of 2024. As noted on our first quarter call, our industry has been facing intermittent challenges across certain healthcare plan providers as it pertains to Medicare Advantage plans. This has impacted growth in certain markets in the adoption of HIFU. To mitigate this issue, we are working diligently with our market access partners to help accelerate preauthorizations for Focal-1 procedures. We are beginning to see ongoing improvements in individual procedure approvals, and we believe the compelling clinical evidence generated from both the large Hi-Fi and FARP studies will be instrumental in gathering expanded coverage while accelerating continued procedure growth. I will now provide a more detailed update on FOCAL 1 reimbursement in the US. In July, the Center for Medicare and Medicaid Services, CMS, announced its annual proposed rule for the hospital payment and physician fees for 2026. The proposed hospital payment for the FOCAL-1 HIFU procedure in 2026 is set at $9,765, which represents an increase of $518, or 5.6%, compared to the current payment in 2025. We view this as positive for our FOCAL-1 business, and more importantly, allows increased patient access to FOCAL-1 robotic HIFU. With respect to the physician reimbursement, CMS has proposed 26.43 total relative value units, or RVUs, for 2026. This translates to a Medicare payment of $888 based on the current proposed conversion factor for qualifying alternative payment model participants. It is important to note that the new codes created in the prostate ablation space for irreversible electroporation, or IRE, and water jet resection received total proposed RVUs that were significantly lower than the one allocated for HIFU prostate ablation, with IRE coming in at 19.76 total RVUs, or $664, and water jet resection at 16.14 total RVUs, or $542. Looking across the landscape for new reimbursement rules for 2026, we remain very well positioned in targeted prostate ablation with HIFU physician fees that are valued measurably higher than those for other competitive procedures such as cryoablation, TULSA, or IRE. Additionally, a new CPT code, Category 3, has been established to report the treatment of benign prostatic hyperplasia, BPH, with the use of HIFU. This new code became effective on July 1, 2025, and CMS has assigned it to the Urology APC Level 6 with an established payment rate similar to the one defined for HIFU in the treatment of prostate cancer. While we do not expect any meaningful revenue for BPH in the short term, we are pleased to see positive reimbursement news for HIFU for the BPH indication. which represents an area of strong interest in our development pipeline. It is important to note that a CPT Category 3 code would enable facilities to be reimbursed for a FOCAL 1 procedure as it would be performed as part of an investigational study in BPH, which maps directly into our current procedure development plans. Before turning the call over to Ken to review our financial results, I would like to provide an update on our corporate strategy. We are pleased to report meaningful progress in the development of our focal one endometriosis application. In March, we received CE marking for use of HIFU in the treatment of rectal endometriosis, an important regulatory milestone that validates the safety and performance of our technology in this new indication. In parallel, clinical evidence supporting this approach continues to grow, highlighted by the recent publication of the multicenter retrospective comparative trial by DuBernard and colleagues in the International Journal of Gynecology and Obstetrics. This study compared HIFU with surgery for rectal endometriosis. Results show that use of Focal-1 HIFU for the noninvasive ablation of endometriosis nodules achieves similar pain relief and quality of life improvements as compared to surgery. However, Focal-1 importantly showed reduced rates of complications while avoiding the typical morbidity associated with major pelvic surgery. Additionally, patients treated with HIFU also experience shorter recovery times and a lower risk of functional side effects. With CE marking now in place, we have initiated the first steps of commercialization in Europe. Beyond the immediate clinical benefit, this represents a significant commercial milestone for EDAP as it positions FOCAL-1 not only as a leading technology in focal therapy for prostate cancer, but as a true multi-application robotic therapeutic ultrasound platform. By expanding into endometriosis, we open the door to a new and very large patient population, which we believe has the potential to accelerate adoption and drive meaningful incremental sales growth for our installed base, including future placements. Now turning attention to development activities within our core therapeutic ultrasound technologies. Based on four decades of experience as a pioneer and market leader in the development and commercialization of extracorporeal shockwave lithotripsy, as well as our ongoing effort in high intensity focused ultrasound, we continue to invest in the research and development of ultrasound energy-based technologies. As a reminder, in November 2024, EDAP announced the achievement of a technical milestone demonstrating the feasibility of non-thermal, non-invasive histotripsy energy delivery using the Focal-1 robotic HIFU system to generate histotripsy lesions in biological tissues ex vivo. As noted, these results were presented at the 187th Acoustical Society of America meeting in November of 2024. marking an important step in the potential expansion of our ultrasound energy-based therapy platform. Building on this foundation, we continue to invest in future development and collaborations to advance the safety, precision, and efficacy of acoustic-based treatment modalities to include histotripsy. We look forward to providing additional updates as we continue to make progress on this front. As announced recently, we have entered into a letter of intent for a strategic financing facility with the European Investment Bank for 36 million euros, or approximately 42 million U.S. dollars. The capital raised through this financing is expected to enhance our balance sheet, offering a substantial source of low-interest funding that will support the continued expansion of Focal-1 robotic HIFU and focal therapy, while accelerating the development of new clinical indications. We also recently announced a transition from being a foreign private issuer to a U.S. domestic filer. Beginning on January 1, 2026, EDAP will begin complying to the U.S. Securities and Exchange Commission reporting rules, as well as NASDAQ listing requirements applicable to U.S. domestic filers. We believe this transition marks an important corporate milestone in our evolution as a public company and underscores our long-term commitment to regulatory best practices, transparency and expanding our presence within the U.S. investor community. We believe this move will benefit our shareholders while positioning the company to attract new institutional investors. Our intention to become a U.S. domestic filer is also consistent with our long-term strategic growth plan as we continue to position the company towards leveraging multiple high-growth opportunities for focal therapy. I will now turn the call over to Ken, who will review our second quarter 2025 results.

Thank you, Ryan, and good morning, everyone. For conversion purposes, our average euro-dollar exchange rate was 1.1489 for the second quarter of 2025. Total revenue for the second quarter of 2025 was 16 million euros, an increase of 1.6% as compared to total revenue of 15.8 million euros for the same period in 2024. The increase in revenue was driven by significant strength in our core HIFU business, which grew 76.8% over the second quarter of 2024. Growth in our HIFU business was offset by expected continued decline in our non-core distribution and ESWL businesses, which declined by 31.2% in Q2 2025 versus Q2 2024. Total HIFU revenue for the second quarter of 2025 was 8.5 million euros as compared to 4.8 million euros for the second quarter of 2024. The 76.8% year-over-year increase in HIFU revenue was driven by nine FOCAL 1 capital sales in the second quarter of 2025 versus three capital sales in the prior year period, as well as a 16.1% year-over-year increase in FOCAL 1 treatment-driven revenue. The second quarter worldwide HIFU disposable revenue was up 23.9% on a year-over-year basis. U.S. procedures grew 4.8% year-over-year. For the first half of 2025, HIFU revenue was 14.7 million euros, an increase of 38.5% compared to the six months ended June 30, 2024. Gross profit for the second quarter of 2025 was 6.8 million euros, compared to 5.9 million euros for the same period a year ago. Gross margin was 42.5% in the second quarter of 2025, compared to 37.5% in the same period a year ago. The increase in gross margin year-over-year was primarily due to the strategic focus on our high-margin HIFU business segments. Gross profit for the six months ended June 30, 2025 was 12.5 million euros compared to 12.3 million euros for the same period in the prior year. Gross margin was 42.3% for the six months ended June 30, 2025 versus 40.1% for the same period in the prior year. Operating expenses were 12.6 million euros for the second quarter of 2025 compared to 12.1 million euros for the same period in 2024. The increase in operating expenses was primarily due to focused investments in our Haifu business. Operating expenses were 24.3 million euros for the six months ended June 30, 2025, compared to 23.3 million euros for the same period in 2024. Operating loss for the second quarter of 2025 was 5.8 million euros compared to an operating loss of 6.1 million euros in the second quarter of 2024. Operating loss for the six months ended June 30, 2025 was 11.8 million euros compared to an operating loss of 11 million euros for the six months ended June 30, 2024. Excluding the impact of non-cash share-based compensation, operating loss for the second quarter would have been 5.3 million euros compared to an operating loss of 5.3 million euros in Q2 2024. Net loss for the second quarter of 2025 was 5.6 million euros or 0.15 euros per share as compared to a net loss of 6.1 million euros or 0.16 euros per share in the same period a year ago. Net loss for the six months ended June 30, 2025 was 12.7 million euros or 0.34 euros per share as compared to a net loss of 10.7 million euros or 0.29 euros per share for the six months ended June 30, 2024. Inventory decreased to $15.5 million in Q2 as compared to 18 million euros at the end of Q1 2025. The decrease in inventory was due to continued efforts in generating efficient, just-in-time inventory management along with higher inventory turnover due to increased demand for Focal 1. Total cash and cash equivalents at the end of Q2 2025 were 16.3 million euros as compared to €22.8 million at the end of Q1 2025. The decrease was driven primarily by the cash used in operating activities to support our strategic investment in Haifu. As Ryan mentioned previously, we entered into a letter of intent for a strategic financing facility with the European Investment Bank, which, upon closing, is expected to strengthen our balance sheets as we continue to advance the future of HIFU. We are actively optimizing cash flow and working capital, positioning ourselves strategically while unlocking the full potential of our HIFU business. I will now provide a brief update on tariffs. Based on the latest updates on U.S. tariff policy, we are forecasting a 15% tariff impact for all goods transferred between France and the U.S. We will continue to closely monitor the potential impact of U.S. tariff policies on a go-forward basis. I would like to now turn the call back to Ryan for closing comments.

Thanks, Ken. The company is updating its 2025 financial guidance. Core HIFU business revenue is now expected to grow within the range of 26% to 34% year-over-year, and our combined non-core ESWL and distribution business revenue is expected to decline within the range of 25% to 30% year-over-year. This compares to our earlier guidance issued at the beginning of the calendar year, which had our core HIFU business growing between 16% and 25%, and our combined non-core ESWL and distribution business revenue declining between 20% and 25% year-over-year. This quarter, we hit a major inflection point for focal one adoption with record second quarter HIFU results signaling the start of accelerated growth. Adoption is being driven by three forces. Strong clinical data validating focal therapy with the use of focal one. Focal one's best in class robotic HIFU platform with increased capabilities. and a growing awareness among patients and physicians. Notably, much of our growth from the U.S. community hospitals in major metropolitan areas, and this is a clear sign that hospitals are responding to rising demand. With our leadership position differentiated technology and expanding footprint, we are poised to both define and lead the rapidly growing focal therapy market for early stage prostate cancer. With that, I will now turn the call over to the operator for questions. Operator.

At this time, if you would like to ask a question, please press star one on your telephone keypad. You may remove yourself from the queue at any time by pressing star two. Once again, that is star one to ask a question. We'll take our first question from Michael Sarcone with Jefferies. Your line is open. Please go ahead.

Good morning, and thanks for taking our questions today. I guess I just wanted to start and dig into some of the payer issues you mentioned, Ryan. I guess you said you're starting to see some improvement there, given that you're working with the market access providers on prior auth. Could you just give us a little color on the efforts you're taking there to improve the reimbursement situation and and maybe what you're baking into the revised HIFU growth guide for the year as it relates to some of that improvement?

Yeah, so to answer your question, Michael, a couple things. One is, obviously, we showed solved growth maintained in our HIFU business year over year. We've stated some challenges tied to Medicare Advantage plans in select markets, but these are being actively addressed. We're proactive in our mitigation, meaning we have strong collaboration with our marketing access partners, helping to accelerate pre-authorizations for focal one procedures. And really, early signs of improvement are emerging with more approvals coming through for individual procedures. We think also, you know, getting and disseminating out the landmark Hi-Fi study and, of course, the FARP study or FARP studies provide compelling clinical evidence that which again, support broader coverage and bolster payer confidence. And equally, we're also seeing an increase in training new urologists seeking to learn how to use FOCAL-1. So I think in context with your question, we've seen activity with Medicare Advantage, but it's been regional, and usually it's addressed right away, and we see, again, a lot of the, what I would say, a lot of the issues we've had kind of resolve, again, using our outside market access partners as well as working with the hospitals, the physicians, and elevating the clinical data as suggested.

Okay, very helpful. I guess just one follow-up there. If we look back to the end of last year, I think your HIFU procedure growth was growing in kind of the 30% plus range, and now we're in the mid-single digits. I guess, you know, do you attribute that decel entirely to some of these regional Medicare advantage issues, or is there anything else going on there? Just trying to get a sense for when you think, you know, we see higher growth. Can we get back to the 20% plus HIFU procedure growth?

Yeah, we're deeply focused on that. And again, as mentioned, where we've had issues with Medicare Advantage plans, which again, we've communicated in the past, we have resolved a lot of those issues. Some of those go on to ALJ rulings, and we've been able to elevate a lot more of the clinical evidence as referenced I would say that we continue to be hyper-focused on our procedure growth. And again, I think there's a couple contributing things is we've seen an increase of urologists at install accounts wanting to be trained on the technology. So we're activating on that. Again, I think we're heading in a positive direction with our procedure growth. We had quarter-over-quarter increase, though it wasn't communicated here, but we had a quarter-over-quarter increase and certainly a year-over-year increase. So we're hyper-focused on it, and I think looking at the activities in our pipeline and pipeline of training new urologists, I think it bears well for future growth.

Great. Thanks a bunch, Ryan. Thank you.

And we'll take our next question from Swayam Pakula Ramakant with H.C. Wainwright. Your line is open. Please go ahead.

Thank you. Good morning, folks. Congratulations on a strong quarter. I'm just trying to understand a little bit more behind CMS trying to increase in the reimbursement rates. So what do the CMS take into account when they are giving you a higher reimbursement rate? You know, do they look into the evidence? Do they look into the procedure volume or the, you know, what are the factors, you know, going to that calculation?

Well, one is they look at, I think, a number of things. Obviously, they look at things across the board. Again, these are average payments. So they look at cost of service in those relative markets. So there's a service to value, clinical value ratio that they use. Additionally, they look at volume of procedures and volume of treatments and billing that comes in. Remember, in our business, we have a disposable as noted, right? For every procedure we perform with Focal One, we also sell a corresponding Focal Pack. So I would say that HIFU is growing categorically. We've seen that data. That is a driver. And there's some incidental things like, you know, in the market, you know, they evaluate everything. The cost of malpractice insurance is factored into that RVU calculation and and et cetera. So we've shown in our communication the proposed rule. The final rule comes out in October. We'll see what happens there. But it's encouraging that CMS really recognizes the value, the value of the HIFU procedure. And I think that's an important sign for us, that the value there, the clinical value, I think the data, all of it, helps determine together what that payment rate may be or that increase. And it's obviously placed into a category. In our case, it's Category 6 or APC 6. So all of that really goes into driving that number and that increase.

Yeah. No, I was just trying to understand, you know, if I can use that as a leading indicator for volume growth and also for – capital purchase growth. So that's why I was just going to ask that question, how they calculate that. In terms of the multi-unit purchases that you talked about, you know, whether it is in the northeast here in the New Jersey area or in the Cleveland Clinic, you know, how much effort is your commercial team placing in such sales?

Well, you know, there's a considerable effort obviously placed in every sale. I'd say, you know, what was such a good sign here is we've seen three distinct regional integrated hospital systems now acquire their second focal one system in Q2. As I referenced earlier, New York Presbyterian, Baptist Health, and Meridian Health as well. in the Northeast. So again, I think it's a strong validation that the technology is bringing value to the institution because when they look at purchases, especially premium price capital equipment, they're looking at the existing programs. And so we've done a very good job of kicking off the original program. And again, it's leading to second system sales within these integrated networks. So I think it's a very positive sign and obviously speaks to the validity and clinical value demonstrated by FOCAL-1.

And then on the BPH, you said that CMS is, I think I understood, if I understood it wrong, please help me. I believe the CMS is providing reimbursement on the BPH indication. So if you have that already and you Doesn't your label allow for use in BPH as such, or do you need to do some additional work to show the utility in BPH?

Yeah, so our labeling allows for ablation of prostate tissue. That would be, as it's stated, that would be cancer and non-cancer, using the terminology. I think here is that the reality is that BPH we are working through a process internally, and I'll just, you know, to bring you back up to speed, we've had an ongoing combined Phase I-II study in France with BPH. We are still recruiting patients in that study, but we're also, importantly, in active discussions with prominent U.S. academic partners and sites. And with our goal to be able to deliver on a U.S. clinical study or kick a study off no later than the early part of next year, 2026. We believe Focal One's precision, high food delivery, and a non-invasive approach really offer a differentiated treatment option for BPH. With that said, if we enter into a study, we'll obviously be enrolling these patients our goal would be to enroll in those patients so we would be able to access reimbursement. But right now, there's not a defined indication, as it's stated, for BPH. We have ablation of prostate tissue, as mentioned, and this gives us an opportunity to further do procedure and clinical development in BPH with the intention of getting into the U.S. market.

Okay. And then on the endometriosis trial, ongoing trial, can you provide us an update on that study?

Yeah, great question. Our phase three double-blinded study, if you remember, the patients who were part of the sham arm at time of unblinding were offered focal one treatment if they wanted treatment per protocol. What's important to understand is over 80% of those sham arm patients chose to have the focal one procedure once unblinded. These patients are now being tracked in a long-term follow-up study. And then importantly, in March, we announced CE-MARC for endometriosis in CE-MARC countries. And currently, we have a limited European launch underway with active patient recruitment and scheduling. And again, we feel, again, our Focal 1i platform, our new platform, was designed with new features tailored for endometriosis. So that's part of this CE Mark Country Limited launch. And so we continue to work through that process. We're excited, as I explained today on the call, an important study comparing endometriosis focal one HIFU ablation of endometrial nodules versus surgery, you can see that they're reading that paper that there may be some very distinct advantages using targeted HIFU therapy versus something more radical such as surgery.

Okay, thank you. One last question. I know I've taken a lot of your time. The 36 million euros that you have signed the letter of intent, How much of that has you already, you know, received? And is all of that pretty much earmarked for development in either in histotripsy or endometriosis studies? Just trying to understand how you're marking those funds.

Yeah, great question, RK. I'll take the first part of the question and I'll have Ryan answer the second. So in our current financials, we've taken no dollars on our balance sheet, okay? We are currently working with the EIB legal and our external counsel to document all the final agreed upon terms. So we'll disclose all the T's and C's once the final agreement is signed. But just to emphasize, no cash from the EIB is currently on our balance sheet. Now, with regards to the funding, I'll let Ryan answer that.

Use of funds are really, you know, targeted for accelerated commercial growth, right, growing our HIFU business, but also investing in some of the clinical indications as referenced, and also some of the new technologies that within our HIFU ecosystem. Anyway, it's a number of things in those distinct areas. We want to grow faster in HIFU and we want to invest properly. With that said, we also have some clinical development areas that we want to support, indications and corresponding studies to support those indications. And then, of course, being a company that has market leadership in our HIFU technology, we want to continue to build on that with new complementary technologies.

Perfect. Thank you. Thank you, gentlemen, for taking all my questions.

Thank you, Orke.

We'll go next to Jason Bednar with Piper Sandler. Your line is open. Please go ahead.

Hey, guys. Can you hear me okay? Hey, Jason. Yes.

Hey, morning. Morning. Yeah, so in the interest of time here, I'll just ask a couple. I wanted to first start, you know, Ryan, you seem confident. I think you made a comment that you're confident the second quarter is an inflection point. If I could just pressure test this, do you have the visibility with respect to your FOCA-1 backlog over the next three to six or six to nine months that you're 2Q isn't as truly an establishment of a trend. The demand sounds good, but we've also seen capital go through fits and starts over the years, even for those that are disruptors or you have new service lines for hospitals. So I guess just trying to get a sense of your confidence level that 2Q truly is sort of a trend and whether 3Q can be as good as what we saw here in 2Q.

Yeah, I said on a go forward basis, looking outward, we believe we've got a very, very strong pipeline. We build on that. We've added some headcount to our commercial teams, and Ken can comment on that. But our pipeline remains strong. We sell a clinically necessary strategic revenue-enhancing service line in the number one cancer in men. And aside from the fact that there's other capital equipment out there, what we sell is clinically necessary Focal therapy is growing as a category quickly. In prostate cancer, it is growing. The numbers support that. We have a technology advantage with our platform. With that said, we're talking about arguably the number one cancer diagnosed in men with reimbursement behind it. You know, all this breathes into that story, but we sell strategic capital. Unlike other companies out there that are selling capital equipment, we really believe that focal one is the core to a focal therapy program in a hospital that treats prostate cancer patients. And so with that said, we believe our pipeline remains strong and growing. Ken can comment on investments we've made on our commercial teams. Ken?

Yeah. So a couple of things, Jason. As Ryan mentioned, we have strengthened our sales team in the U.S. We recently brought in a new central leader. We've added key headcount in key regions where we believe MSA growth is strong. So we are making the investments. Now, I did want to highlight on your revenue question. So just as a reminder, right, Q3 with holidays in Europe tends to spike down, and then we always end the fourth quarter strong. You know, we still see those trends continuing here as we finish the year, but we do feel very confident, hence upping the HIFU revenue growth year over year from 16 to 25 to 26 to 35 for the year.

All right. Thanks, guys. Are you willing to talk about where your backlog sits today, even relative to where we were maybe to start the year or a year ago at this time?

I mean, arguably, I would say it's certainly stronger. As Ken mentioned, we've added more commercial headcount in the right key areas, not only in the U.S., but even in the OUS markets. And we continue to leverage that. We – You know, our pipeline, I would say if you looked at a year in time, and if you, you know, pipeline can be a very vague term, as you know, Jason. When I look at a qualified active pipeline on a year-over-year basis, clearly our pipeline is stronger than it was last year. We have, you know, arguably more boots on the ground, but more importantly, we have a stronger level of engagement. And if you remember, we leveraged the HIFI study which came out the very end of the year. So that has been helping make a notable impact. And our OUS pipeline has also been contributing more to our overall sales. So I'm excited for that. I recruited two strong leaders, Damian Desmet, who was at Intuitive Surgical for 15 years, and Alex Fromm, who also was at Intuitive with me, And they're leading a lot of our key efforts throughout the whole European, Latin America, and Eastern Europe markets to include the Middle East. So I've got a very, what I believe, a strong team in place to help us further drive those sales.

Okay. That makes sense. Last one for me, just on the U.S. procedure volume number, we've touched on it already a bit. I guess I'm curious how patients and hospitals are electing to move forward when some of these reviews get hung up. Are patients electing alternative therapy options? And then are hospitals seeing any, are you seeing any elongation of capital sales trends as a result of what you're seeing play out with these procedure hangups?

No, I don't see any impact on our capital sales. Again, when you do the pro-form analysis, which we commonly do working closely with our hospital customers, we have strong reimbursement in place. And those who invest see this as strategic to their operating plan. We're talking about cancer, cancer in men, men's health, and all these kinds of things. But back to your question on denials and repeals and that process, the appeal process, we worked through that and we've gotten better. And, you know, again, it's regionally based. We have some hospitals that, you know, had a few incidents and then they kind of sailed through and now payers are approving those procedures and approving the reimbursement. So it's, you know, it continues to evolve. I'd say, you know, a lot of our hospitals now are armed with new data and they're using that data, all the dossiers that have been out there reflecting HIFU as a treatment. for prostate cancer are up to date, especially with the HiFi study that's already out. And we will see, ideally, the FAR clinical trial data, the randomized control trial also published. So all this breathes into the opportunity to work through any slowdown with the payers. And we get better too, arguably, as a team working with our market access team outside the company. Again, I feel like we've got good momentum developing. We've got a lot of engagement. Remember, we have a very large, highly impressive academic install base, and many of these folks are activated too in this process. We're in some of the top cancer hospitals and academic centers in prostate cancer on a worldwide basis. So we have everybody involved, and again, we continue to see projected growth.

Thank you. Thank you.

This does conclude today's question and answer session. I will now turn the program back over to Ryan for any additional or closing remarks.

As we close this call, I want to underscore the significance of the growing disease of prostate cancer, the number one diagnosed cancer in men. Each year, September is recognized as Prostate Cancer Awareness Month, a time dedicated to educating, informing, and drawing greater attention to a disease that affects millions of men worldwide. According to projections published by the Lancet Commission on Prostate Cancer in April 2024, The number of diagnosed cases for prostate cancer is expected to double to 2.9 million men by 2040, with the annual deaths rising to 700,000. These numbers are alarming and they demand our collective attention. Awareness is the first step toward action. I encourage each of you to share this knowledge, advocate for early screening, and support initiatives that promote education and research. Together, we can make a meaningful difference in making available newer, effective, less invasive treatment options that both save lives and improve quality of patient care. In closing, I want to thank everyone again for joining us on today's call, and we look forward to seeing you at the upcoming H.T. Wainwright Annual Global Investment Conference on Tuesday, September 9th in New York City.

This does conclude today's program.

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