FocalTherics Q2 2026 Earnings Call Transcript

Quartr
Provided by Quartr
August 13, 2026

Key Takeaways

  • Positive Sentiment: HIFU revenue rose 39% year over year to $13.2 million, driven by 13 Focal One system sales and a 38% increase in treatment-related revenue. U.S. procedure volumes increased 47%, supporting growth in recurring consumables and service revenue.
  • Positive Sentiment: The global Focal One installed base reached 184 systems, including 96 in the U.S., with additional placements at major networks such as Cleveland Clinic and Kaiser Permanente. Management cited a qualified pipeline of approximately 300 potential deals and growing adoption among leading academic institutions.
  • Positive Sentiment: Gross margin improved to 55.6% from 51.1% a year earlier, benefiting from lower system costs, pricing discipline, factory absorption, and increased consumables revenue. CMS has proposed an approximately 12% increase in the 2027 HIFU facility payment, which could further support hospital economics and pricing.
  • Positive Sentiment: The company expects to close a $40 million equity offering and reiterated 2026 continuing-operations HIFU revenue guidance of $50 million to $54 million. Proceeds are intended to fund commercial expansion, BPH and endometriosis programs, and development of histotripsy technology.
  • Negative Sentiment: Operating expenses increased to $15.4 million, while the company reported pressure from foreign exchange, interest expense, tariffs, and a $6.3 million non-cash change in the fair value of European Investment Bank warrants. Shareholders’ equity remained negative at $3.2 million at quarter-end, although management expects the equity raise to improve it in the third quarter.
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Earnings Conference Call
FocalTherics Q2 2026
00:00 / 00:00

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Louisa Smith
Principal at Gilmartin Group

Good afternoon. Thank you for joining us for the FocalTherics second quarter 2026 financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer, and Ken Mobeck, Chief Financial Officer. Before we begin, I would like to remind everyone that management's remarks today may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and involve risks and uncertainties that could cause actual results to differ materially from those anticipated. We direct you to the Risk Factors section of our most recently filed annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission, as well as our other filings with the SEC for a description of factors that may cause such differences.

Louisa Smith
Principal at Gilmartin Group

These statements speak only as of today's date, and we undertake no obligation to update or revise them except as required by law. Additionally, this call is being recorded and constitutes a public disclosure for purposes of Regulation FD. I would now like to turn the call over to Chief Executive Officer Ryan Rhodes.

Ryan Rhodes
CEO at FocalTherics

Thanks, Louisa, and thank you all for joining us on our call today. Before I turn to our second quarter results, I want to take a moment to frame up today's call. We view this as a transformative moment in the evolution of our company's history, including the transition of our name from EDAP to FocalTherics, debuting as a pure-play, high-growth, market-leading focal therapy company. In the first half of this year, we have completed the steps necessary to become a U.S. domestic filer, and we are now reporting our business in U.S. dollars. Additionally, this quarter, we moved our ESWL and distribution businesses to discontinued operations to further establish clarity in our financial reporting in alignment with our strategic priorities.

Ryan Rhodes
CEO at FocalTherics

Now with recently announced equity offering, we believe we are fully capitalized to drive meaningful growth while penetrating our large addressable markets and thus becoming a breakout success story within the healthcare landscape. Our team is encouraged by the notable progress we have made to date, and we are even more excited by the large global opportunity that lies ahead for FocalTherics. I am more confident than ever that we are positioned to emerge as the market leader in the growing category of focal therapy, along with our ability to create durable shareholder value. Now turning to our results. We delivered another strong quarter with $13.2 million in HIFU revenue, representing 39% year-over-year growth. We recorded 13 Focal One capital system sales in the second quarter, a 44% increase, making this our best second quarter ever for HIFU capital system sales globally.

Ryan Rhodes
CEO at FocalTherics

Our total worldwide install base now stands at 184 systems, with 96 in the U.S. and 88 internationally, reflecting the continued broadening of our global commercial footprint across hospitals in both academic and community settings. In the U.S., we recorded eight capital system sales, including two conversions from existing operating leases at Vanderbilt University Medical Center and the University of Michigan, both of which are NCCN member institutions, NCI-designated comprehensive cancer centers, and SUO-approved fellowship programs. Adoption at leading academic institutions such as these allows the next generation of urologists to gain hands-on training and exposure with Focal One through their accredited fellowship programs, which we believe helps build broader clinical awareness and scale as those surgeons move into clinical practice. We now have 15 U.S. hospital networks that have invested in two or more Focal One systems.

Ryan Rhodes
CEO at FocalTherics

During the quarter, there were four hospital networks that invested in an additional Focal One system, including another placement within Cleveland Clinic, which marks our fourth in the U.S. and sixth within their worldwide healthcare network. We also added a second system within Kaiser Permanente, expanding into their San Diego market following the strong performance of their first program in Los Angeles. This expanding footprint across many of the country's most respected healthcare systems continues to validate Focal One's position as the platform of choice for hospitals building a comprehensive focal therapy program, and we believe it reflects growing confidence amongst some of the most influential thought leaders in the field of urology. Internationally, we delivered five capital system sales in the second quarter across Europe, India, and Latin America. This reflects the strength and continued expansion of our global commercial infrastructure.

Ryan Rhodes
CEO at FocalTherics

Of note, Imperial College London in the U.K., one of the pioneering and most highly published focal therapy programs in the world, has converted their HIFU activity from a competitive HIFU technology to Focal One. Reinforcing the growing preference of our technology platform amongst some of Europe's most established focal therapy programs. In France, we completed a new capital sale following the recent announcement of the universal coverage for use of HIFU by the French National Health System. This reimbursement coverage outcome was the result of a landmark large prospective multi-center HiFi study published in December of 2024. We also continue to expand our footprint in several important developing markets outside of Western Europe, including India, where we completed two additional capital system sales as we build our presence in one of the largest and most under-penetrated prostate cancer markets globally. Turning our attention to utilization.

Ryan Rhodes
CEO at FocalTherics

U.S. Focal One procedure volumes increased 47% year-over-year, demonstrating strong usage by existing programs, as well as the impact of new Focal One programs launched during the quarter. This sustained growth demonstrates the durable recurring revenue streams created by each new Focal One system placement. As our install base has grown over the past several years, we continue to see procedure volumes scale, and this quarter's results are a continuation of this positive trend. Turning to our clinical and regulatory programs. In July, we submitted a 510(k) application to the FDA for Focal Connect, our proprietary remote connectivity technology. Focal Connect enables remote maintenance, remote proctoring, peer-to-peer collaboration, and unlocks the opportunity to accelerate surgeon training and broaden patient access to expert care.

Ryan Rhodes
CEO at FocalTherics

For example, an experienced Focal One surgeon can remotely support a physician in real time, whether that connection spans across a single large hospital campus or across a broader regional network. Last year, we demonstrated the scope of this capability with the world's first transcontinental Focal One telecollaboration, where two surgeons within the Cleveland Clinic network in Ohio and Abu Dhabi collaborated to perform a Focal One patient treatment while more than 7,000 mi apart. On the positive reimbursement front, CMS has proposed an increase in HIFU facility payment of approximately 12% for 2027 compared to the current rate for 2026. If confirmed in the final rule, this would represent the fifth consecutive annual increase by CMS in the facility payment for use of Focal One robotic HIFU.

Ryan Rhodes
CEO at FocalTherics

We believe this proposed increase continues to provide hospitals and physicians with a clear and predictable Medicare reimbursement pathway, which supports and justifies an investment in Focal One as the core foundation of a world-class focal therapy program. We will continue to monitor the CMS payment rule as it moves forward toward finalization, which we expect in late fall. We also continue to make progress expanding from prostate cancer into new indications with our BPH clinical program. Through a natural orifice approach and direct access to the prostate without an incision or blood loss, the Focal One platform is ideally suited to treat BPH, or benign prostatic hyperplasia, and its related symptoms.

Ryan Rhodes
CEO at FocalTherics

Leveraging our growing install base and existing community of urologists specialized in prostate care and trained on Focal One, we believe that upon regulatory approval, we are positioned to capture a meaningful share of the large and highly fragmented BPH market. Our ongoing study in Latin America continues to progress with 14 patients treated to date. As a reminder, this initial clinical work is led by U.S. physicians who have received IRB approval to expand their research at the Icahn School of Medicine at Mount Sinai in New York. The first BPH patients in the U.S. are planned for treatment with Focal One later this year in New York. As for indication expansion with endometriosis, we recently announced that Toulouse University Hospital in France became the site of our first commercial endometriosis program in Europe and has since treated several additional patients since the initial program launch.

Ryan Rhodes
CEO at FocalTherics

More than 10 additional hospitals across Europe, the U.K., and Latin America are now moving through our clinical training pathway. With a dedicated CE marking for this clinical application, we continue to view the treatment of deep infiltrating endometriosis as a large and growing market opportunity, offering a treatment option to women suffering from this highly debilitating condition while avoiding major pelvic surgery and its associated complications and morbidity. Together, BPH and endometriosis represent two significant opportunities to expand utilization for use of Focal One. We estimate that across prostate cancer and our expanded indications into BPH and endometriosis, this represents a total addressable market of more than 4.3 million procedures and over $10 billion in potential revenue. With an updated company name, a fortified balance sheet, and a refined reporting structure, FocalTherics is now fully aligned to capture the high-growth opportunity in front of us.

Ryan Rhodes
CEO at FocalTherics

Going forward, we will remain focused on the disciplined execution of our strategic growth plan as reflected in our near and long-term financial targets. With that, I will now turn it over to Ken to review the financials in more detail.

Ken Mobeck
CFO at FocalTherics

Thank you, Ryan, and good afternoon, everyone. Before I turn to our results, I want to spend a moment on a change to our financial reporting. As Ryan mentioned, beginning this quarter, we are classifying our non-core ESWL and distribution businesses as discontinued operations, consistent with our continued and disciplined focus on our core HIFU business. As a result, going forward, our financial statements and related commentary will reflect our HIFU business as continuing operations. I will walk through both our continuing HIFU operations and our discontinued non-core operations to provide a clear basis of comparison as we transition to this new presentation.

Ken Mobeck
CFO at FocalTherics

As we have discussed previously, we believe this removes a layer of complexity that has made it difficult for investors to understand HIFU's underlying financial trajectory on its own terms, the growth rate, margin structure, and the level of investment required to support this core business going forward. We recognize change introduces a new set of comparisons for investors to work through, and we intend to be as clear and consistent as possible as we present this new reporting classification going forward. I'd also like to highlight a key subsequent event related to raising additional equity. On August 14th, we expect to close an underwritten public offering with gross proceeds of $40 million. This amount will be reflected in our cash balance in shareholder equity in the third quarter of 2026.

Ken Mobeck
CFO at FocalTherics

With our recent cash raise, we now feel confident that we have sufficient financial resources to execute on our previously announced strategic priorities. As a reminder, all my commentary, unless otherwise noted, is in reference to the HIFU segment, which is now classified as continued operations. As Ryan mentioned earlier, this was our best second quarter for revenue, which grew 39% compared to the second quarter of 2025. Revenue for the quarter was $13.2 million as compared to $9.5 million for the second quarter of 2025. The 39% year-over-year increase in revenue was driven by 13 capital system sales in the second quarter of 2026 versus nine capital system sales in the prior year period, as well as a 38% increase in Focal One treatment-driven revenue. As mentioned earlier, Focal One procedures in the U.S. grew 47% year-over-year.

Ken Mobeck
CFO at FocalTherics

Gross margin was 55.6%, up from 51.1% in the second quarter of 2025. The 444 basis points increase in gross margin is due to lower Focal One system costs and a disciplined global pricing strategy for our capital system sales. Operating expenses were $15.4 million in the second quarter of 2026, compared to $11.5 million for the second quarter of 2025. The increase in net loss was driven by an incremental operating loss of $1.4 million and unfavorable foreign exchange rate impact of $400,000 compared to the prior period, as well as a $6.3 million non-cash charge related to the change in fair value of the European Investment Bank warrants, as well as interest expense on the tranche A and tranche B drawdown.

Ken Mobeck
CFO at FocalTherics

Turning to the balance sheet, cash and cash equivalents at the end of the second quarter of 2026 were $21.5 million, compared to $15 million at the end of the first quarter of 2026. As previously reported, approximately EUR 14 million for tranche B was drawn under the credit facility agreement with the European Investment Bank in April of 2026. The shareholder equity at the end of the second quarter of 2026 was negative $3.2 million. The negative equity is the result of our recurring losses as well as the impact of recording changes in the fair value of the warrants issued to the European Investment Bank. These non-cash fair value changes are reflected in our statement of operations each quarter and have resulted in an increase in accumulated deficit and a decrease in shareholders' equity of approximately $9 million since the first drawdown of the credit facility.

Ken Mobeck
CFO at FocalTherics

As mentioned above, our recent equity raise will be reflected in the balance sheet during the third quarter of 2026 and will provide a meaningful increase to shareholders' equity. The tariff impact on the second quarter statement of operations and balance sheet was approximately $500,000. Now I will provide you with the financial results pertaining to our non-core ESWL and distribution segments, which are now classified as discontinued operations. Total revenue for discontinued operations for the second quarter of 2026 was $5.6 million, a decline of 34% or $2.9 million compared to the second quarter of 2025, driven primarily by our ongoing termination of distribution agreements in the U.S. and France. Gross margin for discontinued operations was 36.4% in the second quarter of 2026, compared to 32.9% in the same period prior year.

Ken Mobeck
CFO at FocalTherics

Operating expenses for discontinued operations were $2 million in the second quarter of 2026, compared to $2.7 million in the same period prior year. The reduction in operating expenses was due to our strategic shift to invest in our core HIFU business. Operating income for discontinued operations was $21,000 in the second quarter of 2026, compared to operating income of $76,000 in the second quarter of 2025. Net loss for discontinued operations was $75,000 in the second quarter of 2026, compared to net loss of $51,000 in the second quarter of 2025. Inventory balance pertaining to discontinued operations was $4.5 million at the end of the second quarter of 2026, compared to $5.1 million at the end of the calendar year 2025. Turning to guidance, we are reiterating our full year 2026 guidance with continuing operations core HIFU revenue in the range of $50 million-$54 million.

Ken Mobeck
CFO at FocalTherics

I would now like to turn the call back to Ryan for closing comments.

Ryan Rhodes
CEO at FocalTherics

Thanks, Ken. As we look to the second half of 2026, our priorities remain focused on continued commercial execution across our U.S. and international hospital networks and advancing BPH and endometriosis toward broader commercial launch. We remain confident in our ability to build on the momentum established in the first half of the year. We are proud of the work behind our transition to FocalTherics and refining our high-growth strategy, and have tremendous confidence in our ability to capitalize on the opportunities ahead. With that, I will now turn the call back over to the operator for questions. Operator?

Operator

Thank you very much, Mr. Rhodes. Ladies and gentlemen, at this time, if you do have any questions or comments, simply press star one. If you do find your question has been addressed, you may remove yourself from the queue by pressing star two. Additionally, to get to as many questions as possible, we do ask that you please limit yourself to one question and one follow-up. We will go first this afternoon to Anthony Petrone with Mizuho.

Analyst at Mizuho

Hey there. Thanks, guys. Congrats on the quarter. You have Brad on for Anthony today. Maybe the first one, just wanted to talk about box orders, some promising systems getting their second incremental boxes. Just maybe wanted to refresh us on what a mature department looks like, and then also when they're buying a second box today, is that just for the prostate cancers that they're seeing? Is that for additional throughput there, or is it too early to evaluate some of the other indications? Thanks.

Ryan Rhodes
CEO at FocalTherics

Yeah. Our pipeline remains extremely strong. As we shown at in the Investor Day event, New York, we have 300 additional deals that we're working through that are qualified and by no means that are TAM. TAM is significantly higher than that. But back to the sales we made this quarter. One thing of importance is we're growing both in the U.S. and outside U.S., as shown, demonstrated. I think the other comment around this is that we now have 13 centers that have two or more Focal One machines. They've invested to grow their capacity, typically in other hospital sites. An example, of course, is Cleveland Clinic, and as stated, Cleveland Clinic now has six sites operating with Focal One. Again, we continue to focus and execute, and we're excited about the momentum building. Again, the utilization today is really anchored on our prostate cancer business.

Ryan Rhodes
CEO at FocalTherics

BPH and endometriosis are incremental and do play into the narrative for accelerated sales. But we're not materially seeing that as of yet. I think over time, as we progress, that'll become more obvious in our business model.

Analyst at Mizuho

That's helpful. Thanks. Maybe just one, you touched on utilization, but just you've had some strong placements over the last few quarters, three straight quarters and over 10 systems placed. Imagine that the procedure utilization kind of ramps. Maybe just a reminder on when these boxes placed can get to full capacity and kind of how we should think about, I guess specifically the number you give, the U.S. HIFU procedures number, in the back half of this year. Thank you.

Ryan Rhodes
CEO at FocalTherics

We get better all the time onboarding and building programs. In many hospitals, especially in the U.S., we typically see patients already booked in advance of them receiving their Focal One machine. That is a positive sign. That means there is obviously patient demand for this type of treatment, and hospitals then waiting to receive their Focal One system and then training the team, and then onboarding them. Some will ramp faster than others, but typically, we have gotten better at our metrics in terms of the onboarding process. I think that theme will continue to grow and evolve as we sell more centers. Again, there are some hospitals that have invested in the technology because they do not want to lose those patients to a neighboring hospital. I think most would understand the value and utility of focal therapy is real, and you have got to answer to that.

Ryan Rhodes
CEO at FocalTherics

I think as we have demonstrated, Focal One is the top priority when you look at capital purchases supporting their Focal One HIFU program or Focal One program in prostate cancer.

Operator

Thank you. We will go next now to Jason Bednar of Piper Sandler.

Jason Bednar
Jason Bednar
Analyst at Piper Sandler

Hey. Afternoon, everyone. Thanks for taking the questions. With the recent raise in hand or effectively in hand, can you talk about the pushes and pulls of future cash use in order to build out Focal One as a platform across multiple indications and the resourcing that is necessary to accomplish this as you aim for that 40% growth profile? What kind of additional sales resources should we be thinking about? Also, how are you planning for incremental R&D spend to advance this multi-indication approach?

Ryan Rhodes
CEO at FocalTherics

Yeah. We've socialized. The equity raise really supports three buckets of growth. The first is commercial, accelerated commercial growth. It could be investments that we want to make, either in sales structure, marketing, and anything tied to market development and accelerated commercial growth. The second bucket is really the investment we're making in the expanded indications. That includes both BPH and endometriosis. We may run some clinical studies in the U.S. as well. That will be material of value. But we've got a process in place, and we're executing on that. The third area is in new innovative technologies to include the work we're doing in histotripsy. We're very excited about that. As demonstrated in June 1st at our Investor Day, we've already filed some very important patents, and we want to accelerate that development process as well.

Ken Mobeck
CFO at FocalTherics

Also when we look at making these investments, we're also looking to optimize our current infrastructure inside the company and trying to act more efficiently, so we can be very responsible about the additional spending we add to the P&L going forward.

Jason Bednar
Jason Bednar
Analyst at Piper Sandler

All right. If I could double-click and come back just to follow up on specifically the sales resources and the R&D spend. Any quantification you want to give there, Ryan or Ken, around how much additional upside in, say, the sales support line or the R&D line that we should be thinking about as we build our models forward? Then a separate question. I think your disposables and procedure volume growth has been very good for the past 12 months. I think you're coming up against some tougher comps here in the second half of the year. Can volume growth continue to outpace that of total system growth as we look ahead?

Ken Mobeck
CFO at FocalTherics

Yeah. I'll answer the first question. When you look at the investments we need to make into the future, when you look at R&D and SG&A as a percent of revenue, as we grow the top-line revenue, the percentage investments in each of those categories will come down a few percentage points each year. I think that's a good way of looking at as you're building your models for R&D and SG&A. R&D will ramp down a little bit, and then SG&A, as a percent of revenue, will come down nicely because in the U.S., for example, we'll have targeted areas that we will need to invest in the sales growth to build out a few channels, but we won't have to do anything radical.

Ryan Rhodes
CEO at FocalTherics

I would also mention, with BPH, we're already in the urology call point. We're in those hospitals already. We're working with typically the same urologist or the same urology team. We've not looked at adding notable headcount as we move forward with that new indication. I think we can do more with less and scale accordingly.

Jason Bednar
Jason Bednar
Analyst at Piper Sandler

All right. Sorry, just a volume growth question relative to the capital growth question.

Ryan Rhodes
CEO at FocalTherics

Yeah. Again, the way I would look at it is obviously, we're growing in both categories. In capital, in the recurring revenue models, both from our disposables razor blade business as well as our service. The lion's share of revenue will still come from the capital system sales side as of now. But we're encouraged because that was one of the investments we're making to do more on the same platform. If we can offer multiple treatments to include endometriosis in women's health, that allows us obviously to grow our procedures and thus grow more recurring revenue tied to our disposable or consumables business. But in the near term, obviously, capital equipment is going to be the bigger driver, but we will see the notable increases in revenue coming from both capital and from our disposables business.

Jason Bednar
Jason Bednar
Analyst at Piper Sandler

All right. Understood. Thank you.

Ryan Rhodes
CEO at FocalTherics

Thank you.

Operator

We'll go next now to Michael Sarcone with Jefferies.

Michael Sarcone
Michael Sarcone
Analyst at Jefferies

Hey, good afternoon, and thanks for taking the question. I guess just to start, another one on utilization, but just looking at it a different way. When you think about surgeon users, Focal One adopters across your different accounts, how many surgeons are adopting in your highest utilization accounts versus your lower utilization accounts? And I guess, what's the average number of surgeons per an account?

Ryan Rhodes
CEO at FocalTherics

We've spent more time training incremental doctors where appropriate. I would say we've come up in the number of physicians who are accessing or using the technology at a site. Some of our busiest sites, it's commonly at least two doctors. We have some that have as many as seven doctors who have privileges and who are trained and have access to do Focal One procedures. So it ranges by institution. But I'd say if I was going to average it out, I'd say the number would be somewhere probably around 2.5 and trending upward. Some of our busiest sites, if you look specifically across the board, 130 to 140 procedures a year on the higher end. And again, that's with the prostate cancer indication, nothing else. Then if you truncate down into kind of a middle group, you could have that number, somewhere around that.

Ryan Rhodes
CEO at FocalTherics

It takes time to launch and build a program, but we've gotten better at that onboarding process. We typically see, as I mentioned earlier, a faster ramping coming because more hospitals today have a bolus or backlog of patients who are already requesting the Focal One treatment. We're excited for the momentum we're building. There is additional requests for training new doctors, and we answer to that request. Of course, as I referenced earlier, new indications will be important as we think outward in the models in terms of some level of growth. We've been very conservative in some of our models, just because we want to be accurate in terms of what the impact would be at the time of launching, say, BPH or in the limited launch we have going on with endometriosis. We're encouraged with the direction we're going.

Ryan Rhodes
CEO at FocalTherics

I think we have a structured launch plan as we think about adding in these new indications over time.

Michael Sarcone
Michael Sarcone
Analyst at Jefferies

Okay. Thanks, Ryan. Just second question. I think in mid-June you announced an agreement with MellingMedical to expand access for veterans. I just wanted to get a sense for how meaningful is the opportunity at the VA or at different VA hospitals. Are you in any VA hospitals today? When you mentioned that 300 system number for the qualified leads, how much of that is in VA hospitals? Thank you.

Ryan Rhodes
CEO at FocalTherics

Yeah. One of the good things in our install base is we're notably well-represented and continuing to grow our penetration into leading academic centers. Typically there's a VA hospital in close proximity. Right now I can actively say that the engagement with MellingMedical allows us to look deeper at government accounts, VA, and even military accounts. I can tell you where we have three we're working on in our immediate near term VA hospitals, and I think we've got good progress coming together there. The doctors who will come over there in some cases have already been exposed to Focal One because the academic center is likely in very close proximity to that VA hospital.

Ryan Rhodes
CEO at FocalTherics

That works out really well for us, and what I like about it is it exposes both residents and fellows to Focal One robotic HIFU, which they can learn there and then adopt and maybe practice or implement clinically at that VA site. Anyway, but back to that number that I mentioned earlier, there are a handful of VA hospitals that are referenced in those 300 pipeline accounts that we're going after that are qualified. I can't give you the exact number, but some are counted in that number. Not all of them, but some. A lot of upside potential. We're excited about the momentum again as we look outward with VA hospitals.

Michael Sarcone
Michael Sarcone
Analyst at Jefferies

That's helpful. Thank you, Ryan.

Ryan Rhodes
CEO at FocalTherics

Thank you.

Operator

We'll go next now to Sean Lee with H.C. Wainwright.

Sean Lee
Sean Lee
Analyst at H.C. Wainwright

Hey. Good afternoon, Ryan, Ken, and thanks for taking our question. I just have one on the gross margin. It is great to see the improvement this quarter versus last year. What contributed to this increase, and what else do you need to get to the 60% gross margin that you highlighted in your long-term plan?

Ryan Rhodes
CEO at FocalTherics

Yeah, thanks for the question. There are several things that are attributed to our strong gross margin increase. Notably, we finished the year last year, 48% HIFU gross margin. Q1, we finished 51%, and Q2, 55%. The things attributed, number one, really a global disciplined pricing strategy. We implemented our Focal One i system at the end of last year, and we are seeing the good, strong pricing with that product. We worked on lowering our BOM cost reductions with certain materials. As a result of our increase in demand, we are also seeing good, strong factory absorption. When you layer in the increase in consumables and the growth rates of that is also attributing to strong gross margins to date.

Ryan Rhodes
CEO at FocalTherics

As we move forward, we are going to continue to focus strategically on further BOM cost reductions, and we will also see as procedure volumes continue to grow, that is a very accretive margin to our total gross margins. Those are the main factors that will contribute to the gross margin improvement today and in the future. I would also say real quick that notably, the proposed rule came out from CMS, and it is calling for an 11.6% increase in reimbursement. As Ken referenced, we are methodical and very structured in how we offer pricing. This will be the fourth year in a row that HIFU reimbursement has gone up from CMS. That is important because it allows us to revisit our pricing models, which will play accordingly in the improvement of gross margin. Again, I think there are three areas that we can continue to focus on.

Ryan Rhodes
CEO at FocalTherics

We are excited about the direction we are going and we are excited about continuous upside in terms of margin improvement.

Sean Lee
Sean Lee
Analyst at H.C. Wainwright

Got it. That's very helpful, and thanks again for the continued question.

Operator

We'll go next now to Alex Nowak with Lucid Capital Markets.

Alex Nowak
Analyst at Lucid Capital Markets

All right, great. Good afternoon, everyone. Can you speak to the upcoming clinical data that we need to watch out for? The one in particular that I'm watching for is the HIFUSSA study. Anything else we should be watching? Also on the HIFUSSA study, when could we see a readout for that? Just maybe speak to how important that one could be.

Ryan Rhodes
CEO at FocalTherics

Yeah. Great question, Alex. The HIFUSSA study, to my understanding, the patients have been done and treated. I think we're again just in that follow-up period. We will likely see this readout, I would assume it would be potentially the very end of this year in some form factor or maybe the beginning of next year. It is an important study because it is looking at active surveillance. I think again, I'm going to be with the principal investigator on Monday, this coming week, and that's one of the questions I'm going to have for him in getting an update. My understanding is that we should see that published out fairly soon. I can't give you an exact date, but I think it will be an important study.

Ryan Rhodes
CEO at FocalTherics

It's one that many people have been asking about, and we're excited because we know that it will likely be favorable to the story. The story today about use of focal therapy amongst a patient population to include low to intermediate risk.

Alex Nowak
Analyst at Lucid Capital Markets

Yep, absolutely. Good to hear. With the first endometriosis program coming online in Europe, how material do you expect this disease state to be towards the revenue line over the next few quarters? Is this going to be something we're going to see a few more systems get placed directly related to endometriosis? It might be a little premature, but any update on the regulatory strategy for the U.S. market there?

Ryan Rhodes
CEO at FocalTherics

Yeah. Right now, I would say we've got 11 centers that are going through the training pathway, and we're managing that group. We really don't want to expand it yet, just because we're in this onboarding training process, and we want to get these centers up and running. Toulouse University Hospital was an example of one of those sites. In the first quarter of this year, we had three Focal One system sales that were attributed to hospitals knowing that they could treat endometriosis and prostate cancer on the same machine. That's a favorable data point. We'll likely see more of that in the future, especially as it relates to CE mark countries where we're cleared now for endometriosis.

Ryan Rhodes
CEO at FocalTherics

But in terms of the numbers contributing to revenue, I think it will be very small, and will start playing out more next year in 2027, when we really start ramping up things. I'm excited about this because I think, again, it allows us to define ourselves not only in men's health but in women's health. Where are we in the U.S.? We've already won a breakthrough device designation award, and the manuscript for the randomized control trial will be published later this year. That's the expectation. I know it's being submitted to a top-tier high impact journal. But that data set is really important for us because that data set allows us to get back in front of the FDA and have the next conversation as to what is necessary to win a new indication or clearance on endometriosis with Focal One in the U.S.

Ryan Rhodes
CEO at FocalTherics

We are awaiting that publication to come out.

Alex Nowak
Analyst at Lucid Capital Markets

All right. Excellent. Well, appreciate the update. Thank you.

Ryan Rhodes
CEO at FocalTherics

Thank you.

Operator

We will go next now to Josh Jennings with TD Cowen.

Josh Jennings
Josh Jennings
Analyst at TD Cowen

Hi. Good afternoon, Ryan, Ken. Thanks for taking the questions, and it is great to see continuing momentum here. Wanted to just circle up on one of the standouts at the Investor Day, and I think you mentioned earlier in the call, Ryan, on the histotripsy development program, with the new capital, you are going to be able to fund that development more fully.

Josh Jennings
Josh Jennings
Analyst at TD Cowen

It seems like the team is very confident that this development program will be successful and then ultimately you will have a combo HIFU histotripsy technology offering that could be super differentiated. Maybe just help us frame up just, and I know it is too early to talk about regulatory timelines and next steps, but is this a three to five year horizon that we should be thinking about? Maybe just reiterate or review why your team is confident that this development program will be successful. Thank you.

Ryan Rhodes
CEO at FocalTherics

Yeah. So on the Investor Day event on June 1st, we talked about this, and I am glad you brought it up. I think it is an important discussion. As referenced, we have been in sound-based therapy for well over 30 years. Sound-based therapy is in our DNA, and of course, our history in lithotripsy for treating kidney stones naturally sets us up well for adding new technologies to our platform. We have got a full development team in place. We filed a couple patents, as we referenced on June 1st. If I had to point out to a timeline, I would say it is more in the one to two year range. Now, again, we have got critical milestones to hit, and we are working on some of these in the near term, but we have others in front of us. It is a high focus for us.

Ryan Rhodes
CEO at FocalTherics

I think because of our background and work in lithotripsy and, of course, in HIFU, which is another sound-based therapy, this fits really nicely into the Focal One ecosystem. It is a high priority, and we have got the best and brightest working on it. We are excited because of the equity raise. We can fund accelerated growth here, and we are going to continue to make prudent investments in this specific area. We are excited. Thank you.

Josh Jennings
Josh Jennings
Analyst at TD Cowen

Outstanding. Thanks again.

Operator

Thank you. Ladies and gentlemen, that's all the time we have for questions this afternoon. Mr. Rhodes, I'd like to turn things back to you, sir, for any closing comments.

Ryan Rhodes
CEO at FocalTherics

Before we conclude today's call, I'd like to underscore the broader significance of the work we are doing in prostate cancer. Prostate cancer remains one of the most commonly diagnosed cancers in men, and its global burden is expected to rise substantially. The Lancet Commission projects annual cases could reach approximately 2.9 million by calendar year 2040, with deaths approaching 700,000 each year. Against that backdrop, we see a meaningful opportunity to advance the standard of care for appropriately selected patients. The growing momentum we are building across our global business reinforces our conviction in that opportunity as we expand the adoption of Focal One and deepen our relationship with physicians, hospitals, and health systems. Focal One robotic HIFU offers a non-invasive, organ-sparing, and function-preserving approach that enables physicians to precisely target cancerous tissue while preserving surrounding healthy tissue.

Ryan Rhodes
CEO at FocalTherics

For certain patients, it can provide an alternative to help delay more radical whole-gland therapies that carry the risk of greater morbidity and lasting urinary and sexual side effects. As we approach Prostate Cancer Awareness Month in September, we are reminded of the importance of awareness, early detection, education, and access to these important innovative treatment options. At FocalTherics, we remain committed to expanding access to technologies that help physicians treat prostate cancer effectively while preserving quality of life. We are grateful to our employees, physician partners, hospital customers, investors, and other stakeholders who support that mission. Thank you again for joining us today. We appreciate your continued interest in FocalTherics and look forward to updating you on our progress in the coming quarters.

Operator

Thank you, Mr. Rhodes. Again, ladies and gentlemen, this does end today's meeting. We do appreciate your time and participation. You may now disconnect.

Executives
    • Ryan Rhodes
      CEO
    • Ken Mobeck
      CFO
Analysts
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