Earnings Call Transcript - EDAP Q2 2025

Operator, Operator

Good day, everyone, and welcome to today's EDAP Second Quarter 2025 Earnings Conference Call. Please note, this call is being recorded. It is now my pleasure to turn the conference over to John Fraunces with LifeSci Advisors. Please go ahead.

John P. Fraunces, LifeSci Advisors

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 Mobeck, Chief Financial Officer; and Francois Dietsch, Chief Accounting Officer. Before we begin, I would like to remind everyone that management's remarks today may contain forward-looking statements, which include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such forward-looking statements. Factors that may cause such a difference include but are not limited to those described in the company's filings with the Securities and Exchange Commission. I would now like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes. Ryan?

Ryan Rhodes, CEO

Thank you, John, and good morning, everyone. As we will review today, EDAP Focal One HIFU remains instrumental in driving the execution of our defined growth strategy. In Q2, we experienced strong and accelerating demand for Focal One robotic HIFU. We reported global HIFU revenues of USD 9.7 million, 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 9 capital sales, including 1 conversion of an operating lease to a capital sale at Kaiser Permanente as well as operating leases at 4 large hospital systems. We are encouraged to see hospital networks from our current installed base such as Hackensack Meridian Health, Baptist Health and NewYork-Presbyterian Health purchased 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 4 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 Focal One 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 3 main factors: First and foremost, increased demand for Focal One 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 1 data from the randomized controlled FARP 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 i has been actively embraced by more and more urologists. The groundbreaking new features and design of the Focal One i 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 i's digital interface and fully robotic HIFU energy delivery design is uniquely suited to enable remote proctoring and remote collaborative procedures as demonstrated by our 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 One i 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 One i 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 One and are weighing their treatment decisions accordingly, which further drives urologists' interest in adopting our Focal One HIFU platform. It is clear that patients want to access a noninvasive 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 health care plan providers as it pertains to Medicare Advantage plans. This has impacted growth in certain markets and the adoption of HIFU. To mitigate this issue, we are working diligently with our market access partners to help accelerate pre-authorizations for Focal One procedures. We are beginning to see ongoing improvements in individual procedure approvals, and we believe the compelling clinical evidence generated from both the large HIFI 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 One reimbursement in the U.S. In July, the Centers 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 One 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 One business and, more importantly, allows increased patient access to Focal One 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 waterjet 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 waterjet 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 III 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 VI 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 III code would enable facilities to be reimbursed for a Focal One 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 One HIFU for the noninvasive ablation of endometriosis nodules achieved similar pain relief and quality of life improvements as compared to surgery. However, Focal One importantly showed reduced rates of complications while avoiding the typical morbidity associated with major pelvic surgery. Additionally, patients treated with HIFU also experienced 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 One 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 opened 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 4 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 nonthermal, noninvasive histotripsy energy delivery using the Focal One 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, including 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 EUR 36 million or approximately USD 42 million. 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 One Robotic HIFU in 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 with 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.

Ken Mobeck, CFO

Thank you, Ryan, and good morning, everyone. For conversion purposes, our average euro-dollar exchange rate was USD 1.1489 for the second quarter of 2025. Total revenue for the second quarter of 2025 was EUR 16 million, an increase of 1.6% as compared to total revenue of EUR 15.8 million 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 noncore 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 EUR 8.5 million as compared to EUR 4.8 million for the second quarter of 2024. The 76.8% year-over-year increase in HIFU revenue was driven by 9 Focal One capital sales in the second quarter of 2025 versus 3 capital sales in the prior year period as well as a 16.1% year-over-year increase in Focal One 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 EUR 14.7 million, an increase of 38.5% compared to the 6 months ended June 30, 2024. Gross profit for the second quarter of 2025 was EUR 6.8 million compared to EUR 5.9 million 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 segment. Gross profit for the 6 months ended June 30, 2025, was EUR 12.5 million compared to EUR 12.3 million for the same period in the prior year. Gross margin was 42.3% for the 6 months ended June 30, 2025, versus 40.1% for the same period in the prior year. Operating expenses were EUR 12.6 million for the second quarter of 2025 compared to EUR 12.1 million for the same period in 2024. The increase in operating expenses was primarily due to focused investments in our HIFU business. Operating expenses were EUR 24.3 million for the 6 months ended June 30, 2025, compared to EUR 23.3 million for the same period in 2024. Operating loss for the second quarter of 2025 was EUR 5.8 million compared to an operating loss of EUR 6.1 million in the second quarter of 2024. Operating loss for the 6 months ended June 30, 2025, was EUR 11.8 million compared to an operating loss of EUR 11 million for the 6 months ended June 30, 2024. Excluding the impact of noncash share-based compensation, operating loss for the second quarter would have been EUR 5.3 million compared to an operating loss of EUR 5.3 million in Q2 2024. Net loss for the second quarter of 2025 was EUR 5.6 million or EUR 0.15 per share as compared to a net loss of EUR 6.1 million or EUR 0.16 per share in the same period a year ago. Net loss for the 6 months ended June 30, 2025 was EUR 12.7 million or EUR 0.34 per share as compared to a net loss of EUR 10.7 million or EUR 0.29 per share for the 6 months ended June 30, 2024. Inventory decreased to EUR 15.5 million in Q2 as compared to EUR 18 million 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 One. Total cash and cash equivalents at the end of Q2 2025 were EUR 16.3 million as compared to EUR 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 HIFU. 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 sheet 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.

Ryan Rhodes, CEO

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 noncore 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 noncore 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 3 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, Operator

We'll take our first question from Michael Sarcone with Jefferies.

Michael Anthony Sarcone, Analyst

I guess 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 authorization. Could you just give us a little color on the efforts you're taking there to improve the reimbursement situation and maybe what you're baking into the revised HIFU growth guide for the year as it relates to some of that improvement?

Ryan Rhodes, CEO

Yes. So to answer your question, Michael, a couple of things. One is, obviously, we showed solid 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 market 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 getting and disseminating the landmark HIFI study and, of course, the F-A-R-P study provide compelling clinical evidence which again supports broader coverage and bolsters payer confidence. Equally, we are also seeing an increase in training new urologists seeking to learn how to use Focal One. 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 issues we've had kind of resolved, again, using our outside market access partners as well as working with the hospitals, the physicians and elevating the clinical data as suggested.

Michael Anthony Sarcone, Analyst

Okay. Very helpful. And 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 at kind of the 30% plus range, and now we're in the mid-single digits. I guess do you attribute that deceleration 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 we see higher growth. Can we get back to the 20% plus HIFU procedure growth?

Ryan Rhodes, CEO

Yes, we are very focused on that. As previously mentioned, we had issues with Medicare Advantage plans, but we have resolved many of those. Some of these are undergoing ALJ rulings, and we have been able to present more of the clinical evidence. We continue to concentrate on our procedure growth. One factor contributing to this is the increase in urologists at our installed accounts wanting to be trained on the technology. We're actively pursuing that. I believe we are moving in a positive direction with our procedure growth. We experienced a quarter-over-quarter increase, although it wasn't highlighted here, and certainly a year-over-year increase. We remain highly focused on this area. Considering the activities in our pipeline and our training programs for new urologists, I believe this sets up well for future growth.

Operator, Operator

And we'll take our next question from Swayampakula Ramakanth with H.C. Wainwright.

Swayampakula Ramakanth, Analyst

Congratulations on a strong quarter. Just trying to understand a little bit more behind CMS trying to increase the reimbursement rates. So what do the CMS take into account when they are giving you a higher reimbursement rate? Do they look into the evidence? Do they look into the procedure volume or what other factors go into that calculation?

Ryan Rhodes, CEO

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 in the market that they evaluate everything. The cost of malpractice insurance is factored into that RVU calculation, 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 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 VI or APC VI. So all of that really goes into driving that number and that increase.

Swayampakula Ramakanth, Analyst

Yes. No, I was just trying to understand 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 trying to ask that question, how they calculate that. In terms of the multi-unit purchases that you talked about, whether it is in the Northeast here in the New Jersey area or in the Cleveland Clinic, how much effort is your commercial team placing in such sales?

Ryan Rhodes, CEO

Well, there's considerable effort, obviously, placed in every sale. I'd say what was such a good sign here is we've seen 3 distinct regional integrated hospital systems now acquire their second Focal One system in Q2. As I referenced earlier, NewYork-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-priced 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 One.

Swayampakula Ramakanth, Analyst

And then regarding the BPH, I understand that CMS is providing reimbursement for the BPH indication. If that is accurate, does your label already allow for use in BPH, or do you need to conduct additional work to demonstrate its utility in that area?

Ryan Rhodes, CEO

Yes. Our labeling allows for the ablation of prostate tissue, including both cancerous and noncancerous tissue. We are currently working through an internal process. To update you, we have been conducting a combined Phase I/II study in France for benign prostatic hyperplasia (BPH) and are still recruiting patients for that study. Additionally, we are actively in discussions with notable U.S. academic partners and sites. Our aim is to initiate a U.S. clinical study by early 2026. We believe that Focal One's precision, high-intensity focused ultrasound (HIFU) delivery, and noninvasive approach provide a unique treatment option for BPH. If we move forward with a study, we plan to enroll patients accordingly to facilitate access to reimbursement. However, we currently do not have a defined indication for BPH. The ablation of prostate tissue provides us with an opportunity to further develop procedures and clinical applications for BPH with the goal of entering the U.S. market.

Swayampakula Ramakanth, Analyst

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

Ryan Rhodes, CEO

Yes. Great question. Our Phase III double-blinded study, if you remember, the patients who were part of the sham arm at the 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 mark for endometriosis in CE mark countries. And currently, we have a limited European launch underway with active patient recruitment and scheduling. And again, we feel, again, our Focal One i 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 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.

Swayampakula Ramakanth, Analyst

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

Ken Mobeck, CFO

Yes. 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. 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 terms and conditions 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.

Ryan Rhodes, CEO

The use of funds is focused on driving commercial growth, specifically expanding our HIFU business while also investing in certain clinical indications and new technologies within our HIFU ecosystem. We have multiple initiatives in these distinct areas. Our goal is to accelerate growth in HIFU and ensure we invest effectively. Additionally, we are supporting clinical development areas to correspond with indications and studies that back those indications. Furthermore, since we lead the market in our HIFU technology, we aim to enhance that position with new complementary technologies.

Operator, Operator

We'll go next to Jason Bednar with Piper Sandler. Can you hear me okay?

Jason M. Bednar, Analyst

So in the interest of time here, just ask a couple. I wanted to first start, Ryan, you seem confident. I think you made a comment that your comp in the second quarter is an inflection point. If I could just pressure test this, do you have the visibility with respect to your Focal One backlog over the next 3 to 6 or 6 to 9 months that 2Q isn't 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 have new service lines for hospitals. So I guess just trying to get a sense of your confidence level that 2Q truly is the start of a trend and whether 3Q can be as good as what we saw here in 2Q.

Ryan Rhodes, CEO

Yes, looking ahead, we believe we have a very strong pipeline. We have added some headcount to our commercial teams, and Ken can provide more details on that. Our pipeline remains robust. We offer a clinically essential strategic service line for the leading cancer in men. Although there are other capital equipment options available, our offerings are necessary from a clinical standpoint. Focal therapy is rapidly growing, particularly in prostate cancer, and the data supports this growth. We have a technological advantage with our platform. This is particularly relevant as we discuss the predominant cancer diagnosed in men, supported by reimbursement. All of this contributes to our narrative, as we provide strategic capital, unlike some companies that supply capital equipment. We firmly believe that Focal One is essential for any focal therapy program in hospitals treating prostate cancer patients. Therefore, we are confident that our pipeline is strong and continues to grow. Ken can elaborate on the investments we've made in our commercial teams. Ken?

Ken Mobeck, CFO

Yes. 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 market share 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. 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.

Jason M. Bednar, Analyst

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?

Ryan Rhodes, CEO

I believe it's definitely stronger. As Ken mentioned, we've increased our commercial headcount in key areas, not only in the U.S. but also in international markets, and we're continuing to build on that. When looking at our qualified active pipeline on a year-over-year basis, it's clear that our pipeline is stronger than last year. We have more resources in the field, but more importantly, we have a higher level of engagement. The HIFI study, which was released at the end of last year, has had a significant impact. Our international pipeline has been contributing more to our overall sales, which I'm excited about. I've brought on two strong leaders, Damien Desmedt, who has been with Intuitive Surgical for 15 years, and Alex Fromm, who also has experience at Intuitive. They are leading many of our key initiatives across Europe, Latin America, Eastern Europe, and the Middle East. I believe we have a strong team in place to help drive our sales further.

Jason M. Bednar, Analyst

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'm curious how patients and hospitals are choosing to move forward when some of these reviews get delayed. Are patients opting for alternative therapy options? And are hospitals experiencing any elongation in capital sales trends due to these procedure delays?

Ryan Rhodes, CEO

I don't see any impact on our capital sales. When we conduct our pro forma analysis, which we regularly do while collaborating closely with our hospital customers, we have strong reimbursement in place. Those who invest view this as a strategic part of their operating plans. We are discussing cancer, particularly in men and men's health. Concerning denials and appeals, we navigate that process and have improved over time. It varies by region; some hospitals have encountered a few issues but have since progressed, with payers now approving those procedures and enhancing reimbursement. This situation continues to evolve. Many of our hospitals are now equipped with updated data and are utilizing it. All the dossiers supporting HIFU as a prostate cancer treatment are current, especially with the HIFI study published, and we anticipate the FARP clinical trial data to be released as well. This sets the stage to address any delays with payers. We are also improving as a team by collaborating with our market access team outside the company. I believe we have developed good momentum and engagement. We boast a substantial and highly respected academic installed base, with many involved in this process. We are present in some of the leading cancer hospitals and academic centers for prostate cancer globally. Overall, we continue to project growth.

Operator, Operator

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.

Ryan Rhodes, CEO

As we close this call, I want to underscore the significance of the growing disease of prostate cancer, the #1 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.C. Wainwright Annual Global Investment Conference on Tuesday, September 9, in New York City. Thank you.

Operator, Operator

This does conclude today's program. Thank you for your participation. You may disconnect at any time.