Profound Medical Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 6, 2026

Key Takeaways

  • Positive Sentiment: Full-year outlook maintained: Profound reported Q2 revenue of 2.5 million, up 12% year over year, but said approximately 3.1 million of shipments slipped into July. Excluding the timing issue, revenue would have been about 5.6 million, and management reiterated its 25 million 2026 revenue target, representing 56% growth.
  • Positive Sentiment: Commercial momentum and reimbursement are expanding: The qualified sales pipeline for TULSA-PRO and Sonalleve reached approximately 70 million, with roughly 90% attributed to TULSA-PRO. Proposed 2027 Medicare reimbursement would pay hospitals 15,494 per TULSA procedure, a growing premium over HIFU, Aquablation, and robotic prostatectomy, while other payer coverage expanded by approximately 18.3 million lives in Q2.
  • Positive Sentiment: Clinical evidence continues to support TULSA: Management highlighted CAPTAIN trial results showing statistically better quality-of-life outcomes than robotic prostatectomy, including preservation of urinary continence and erectile function, fewer serious complications, faster recovery, and no overnight stay. New data also indicated no median penile-length reduction after TULSA versus a 0.65-centimeter reduction after robotic surgery at one month.
  • Negative Sentiment: Execution and utilization remain uneven: The company experienced shipment-recognition delays because delivery receipts were not received before quarter-end, while five sites underperformed expectations and sequential utilization declined 12%. Profound said it is adding logistics and operating personnel, and that installations typically require 60–120 days after shipment to begin treating patients.
  • Neutral Sentiment: Financial position and growth investments: Profound ended Q2 with 38.3 million in cash and reduced its net loss to 9.5 million from 15.7 million a year earlier, while maintaining gross margin of at least 70%. Management expects operating expenses to rise as it expands its teams, but continues to target a path toward profitable growth.
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Earnings Conference Call
Profound Medical Q2 2026
00:00 / 00:00

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Operator

Good day. Thank you for standing by. Welcome to Profound Medical's Second Quarter 2026 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Stephen Kilmer, Investor Relations.

Stephen Kilmer
Stephen Kilmer
Investor Relations Contact at Profound Medical

Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws in the United States and Canada. All forward-looking statements are based on Profound's current beliefs, assumptions, and expectations and relate to, among other things, any express or implied statements or guidance regarding current or future financial performance and position and expectations regarding the efficacy of Profound's technology. Such statements involve known and unknown risks and uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. Representing the company today are Dr. Arun Menawat, Profound's Chief Executive Officer and Chairman, Dr. Mathieu Burtnyk, Profound's President, and Tom Tamberrino, our Chief Commercial Officer. Also filling in for our CFO due to a scheduling issue is our Corporate Controller, Matthew Sobczyk. With that said, I'll now turn the call over to Matthew.

Matthew Sobczyk
Matthew Sobczyk
Corporate Controller at Profound Medical

Good afternoon, everyone. Welcome to the Second Quarter 2026 Conference Call. On behalf of the management team and everyone at Profound, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I will turn the call over to Mathieu in a moment to provide clinical updates. Before I do, I would like to provide a brief summary of our second quarter 2026 financial results. All of the numbers I will refer to have been rounded, so they are approximate. For the three-month period ended June 30th, 2026, the company recorded revenue of $2.5 million, with $1.6 million from recurring revenue and $871,000 from capital equipment sales.

Matthew Sobczyk
Matthew Sobczyk
Corporate Controller at Profound Medical

Second quarter 2026 revenue was up 12% from $2.2 million for the same three-month period a year-ago. As noted in today's press release, this doesn't fully reflect our sales performance in Q2 2026. Approximately $3.1 million of TULSA product shipments originally anticipated in the final weeks of June were completed in July, affecting the period of revenue recognition. Excluding the shipment timing, second quarter revenue would have been approximately $5.6 million, representing 153% year-over-year growth. Gross margin in Q2 2026 was 78% compared to 73% in Q2 2025. We continue to have confidence that the gross margin for our business will remain above our stated goals of over 70% over the long haul.

Matthew Sobczyk
Matthew Sobczyk
Corporate Controller at Profound Medical

Overall, the company recorded a second quarter 2026 net loss of $9.5 million or $0.26 per common share, compared to a net loss of approximately $15.7 million or $0.52 per common share in the three months ended June 30th, 2025. As of June 30th, 2026, Profound had cash of $38.3 million. As Tom and Arun will discuss later in the call, despite the revenue recognition timing issue in the second quarter, based on record order activity, Profound continues to project total revenue for full-year 2026 to be approximately $25 million, which represents 56% growth compared to its prior year revenue. With that, I'll now turn the call over to Mathieu Burtnyk for an update on clinical and development activities.

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

Thank you. Good afternoon. On past calls, I've highlighted the growing body of clinical evidence supporting the TULSA procedure as a new platform for prostate disease management, capable of delivering whole-gland treatment efficacy while preserving quality of life. The CAPTAIN trial has already proven that TULSA delivered statistically superior quality of life outcomes compared to robotic radical prostatectomy, achieving its primary safety endpoint with statistically higher preservation of the composite endpoint of urinary incontinence and erectile function at six months. In addition, patients treated with TULSA experienced superior perioperative outcomes, including no blood loss, no overnight hospital stay, less pain, and faster recovery, along with statistically significantly fewer serious complications and a faster return to normal activities and paid employment.

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

Most recently, at SRS, we presented positive incremental data from CAPTAIN demonstrating that whole-gland TULSA provided statistically superior penile length preservation compared to robotic prostatectomy. At one month following the TULSA procedure, there was no median change in penile length after TULSA, compared with a median 0.65 cm reduction in penile length after robotic prostatectomy. To some people, and please pardon the pun, that might not sound like a super big deal, but even modest amounts of penile shortening can contribute meaningfully to patient distress and reduce satisfaction following treatment. This new data points to the greater peace of mind that the TULSA procedure can deliver to patients by gently, safely, and precisely ablating prostate tissue while actively protecting surrounding structures such as the prostatic urethra.

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

As we noted before, one of CAPTAIN's primary objectives is to support broader payer coverage. Randomized controlled trials remain the gold standard for coverage decisions, and CAPTAIN continues to generate evidence demonstrating meaningful quality of life advantages that resonate with both patients and payers. In addition to ongoing CAPTAIN readouts and analyses, the clinical value of TULSA is continuing to become sharper as presentations focus more on what specifically makes TULSA most versatile.

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

Beyond demonstrating overall efficacy and quality of life benefits, ongoing clinical analyses are increasingly helping physicians understand where TULSA's capabilities may be particularly valuable. Examples include patients with apical cancer, where the enhanced visualization of the MR allows urologists to precisely carve out tumor from the boundary of the sphincter muscle that controls continence. These patients almost always end up with urinary incontinence following robotic RP, but whose continence can almost always be saved if treated with TULSA. Secondly, patients with unilateral disease or cancer on one side of the prostate and whose nerves that maintain erectile function can be spared by not ablating the benign side of the prostate.

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

Thirdly, patients where multiparametric MRI provides a clear hot zone that is suspicious of cancer within the prostate, and thereby giving surgeons better guidance of what part of the prostate to kill. And patients with very large prostates, where TULSA has demonstrated treatment flexibility without the increased side effect burden often associated with other modalities. I'd like to conclude my remarks by reiterating that from gold standard treatment effect findings to TACT durable five-year outcomes to CAPTAIN's compelling level one data, the clinical foundation supporting TULSA continues to strengthen. We believe this growing body of evidence increasingly positions TULSA as a differentiated platform capable of delivering whole-gland efficacy, superior quality of life outcomes, and expanded reimbursement support. I will now turn the call over to Tom.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

Thank you. There's no question that momentum in our business is continuing to build. As Matthew Sobczyk mentioned, we recorded a year-over-year increase of 12%, which would have been 153% absent the $3.1 million shift in Q2 orders that were shipped in July and will be recognized in the current quarter. Speaking of temporary interruptions, you may have also noticed that while same-store sequential quarter-over-quarter growth, as measured by our new Index 20, declined by 12%, it grew 39% in the first half of 2026 over the same period in 2025, and 22% year-over-year. The sequential change was mainly attributable to five sites not realizing the expected growth due to short-term issues. For example, one of the sites converted from a placement to a capital model in Q2 and paused treatments during the transition.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

That site is now back online. Despite these one-time and/or temporary issues, Q2 2026 marked another true commercial inflection point. So far, we have seen that momentum continue into Q3. We estimate that our qualified sales pipeline, defined as being within one of the verified, negotiate, and contracting stages for TULSA-PRO and Sonalleve, is now approximately $70 million. While we can't predict the extent and/or timing which that qualified sales pipeline will translate into recognized revenue, it has been growing steadily, which certainly bodes well for the future. We had another monthly record for new orders in July, none of which included any of the shift or rollover from Q2. SRS 2026 was the most productive medical meeting I have ever been a part of.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

To put that into perspective, our team's work generated more than 160 qualified leads over the four days of the event, so around four or five new commercial opportunities per hour.Again, it's not possible to predict what number of those will translate into actual sales, but also again, boding well for the future. Three additional tailwinds helping drive our commercial momentum acceleration are higher and expanding reimbursement. With respect to Medicare, a few weeks ago, CMS released the current year 2027 hospital outpatient prospective payment system, or OPPS, and ambulatory surgical center, or ASC, proposed rules. Under the OPPS proposal, TULSA furthers its favorable reimbursement level relative to other treatment modalities. To summarize those proposed changes, TULSA remains at urology APC Level 7, with OPPS payment increasing 14.9% to $15,494 per procedure. That compares to an 11.6% increase for HIFU and Aquablation to $10,797, and $12,300 for robotic RP.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

Assuming the final rule doesn't change these numbers, starting in January 2027, hospitals will be paid 44%, or $4,697 more per procedure for TULSA than HIFU and Aquablation, and 26%, or $3,194 more for TULSA than robotic RP. Keeping in mind that hospitals can generally perform as many or more TULSA procedures versus those other modalities in a day, our premium there is clearly growing, making our relative profitability for hospitals higher as well. With respect to ASCs, the proposed rule would reduce TULSA to $6,866. However, we don't currently have any active ASC sites, and we believe there may be an opportunity for us to correct the hospital cost reporting that appears to have drove the reduction. On the physician payment schedule side, TULSA is more than holding its ground as well when viewed on an apples-to-apples basis.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

Adjusting for the fact that TULSA is zero day while competitors are 90 day, physicians will be paid $880 for each TULSA procedure compared to $865 for HIFU, $1,064 for robotic RP, and $539 for Aquablation. Turning to other payers, coverage for the TULSA procedure expanded by approximately 18.3 million covered lives during the second quarter. Most of the newly covered lives came through state Medicaid and managed Medicaid and better programs. This follows the addition of 8.5 million covered lives in the first quarter, which included 6.9 million covered lives with Humana. Just today, we announced that the Johns Hopkins and the Prime Healthcare employee health plans, together covering more than 105,000 employees, medical staff and family members have become the first ever employer-owned health plan to list the TULSA procedure as a covered service. We're just getting started.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

Profound will continue to work collaboratively with payers, providers, and health systems to expand coverage and streamline patient access pathways for the TULSA procedure. Looking ahead, I'm confident in our ability to further accelerate. We're well-positioned to capitalize on the expanding interest in image-guided, incisionless, and autonomous robotic surgery. We're anticipating an extended reimbursement premium for TULSA hospitals and physicians. We're growing an already formal body of clinical evidence demonstrating the superiority of our technology, and we're continuing to scale our commercial footprint both at home and abroad. Thank you for your time. I'll turn the call over to Arun now.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Thanks, Tom, good afternoon, everyone. As I discussed in our Q1 call, the dynamics in the prostate disease treatment space continue to change at a rapid pace. Whole-gland robotic prostatectomy or radiation therapy are the standard of care for treating prostate cancer today. For BPH, mainstream treatment with transurethral resection of the prostate, or TURP, has largely been unchanged over the past 100 years. It remains our belief that today's standards have plateaued, that we can do better than the clinical outcomes from these standards. Just a few days ago, at SRS 2026, we saw firsthand that robotic surgeons are beginning to not only understand the potential of TULSA clinically, but also recognize that TULSA is the only prostate treatment system that is MRI guided.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

TULSA is the only modality that offers the flexibility to treat the prostate gland regionally, meaning with whole or near-gland subtotal, [inaudible], or focal ablation. The time for incisionless surgery has come. The most tangible evidence of this is that the new Society of Incisionless Surgery, or SIS, began its activities at SRS 2026. Profound, HistoSonics, and Insightec are among the most prominent founding members of the new society. TULSA is the only modality that deploys supervised robotic autonomy, meaning it executes predetermined and/or AI-driven tasks independently. This compares to all competitive so-called master/slave robotic systems that rely entirely on direct, real-time human hand movement and control. Today, TULSA's autonomous robotics enables surgeons to deliver consistent, highly personalized treatment based on each patient's unique anatomy and disease.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

In the future, it may also give us an even stronger competitive advantage in incisionless surgery advances to its next frontier, including potentially telesurgery. With respect to MRI guidance, I would like to directly address what many of our competitors have tried to use as a mark against TULSA. While it is true that as we first started commercialization, finding compatible MR available time and convincing urology and radiology to work together to adopt a TULSA program was a hurdle to climb. Today, TULSA is compatible with an install base of about 5,000 MRIs in the United States. and more worldwide, that number continues to grow.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

It is therefore a lot easier to find an MR and justify TULSA, particularly with the economic proposition, as its facility fee is already higher than that of any other treatment modality. Based on the proposed rule for 2027, the TULSA premium is only going to get higher. Our relationship with MR companies also continues to expand as they see interventional MRs as a growth opportunity for them, too. As we have talked about on the past calls, MRs specifically designed for interventional procedures are now becoming commercially available. These MRs are significantly smaller, lighter, and easier to use to the point that even an MR tech is not necessary to operate them. They are also less costly to acquire and maintain and can be placed just about anywhere, since they don't need the same shielding as larger magnets.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

The Siemens Free Series, which is a prime example of such an MR, Cook Medical has created an iMRI division with the purpose of selling a turnkey interventional MR solution to hospitals that includes the smaller Siemens MR. The idea is that just as cath labs or robotic operating rooms were created in the past, the future is about creating interventional MR suites. We currently anticipate if all goes well, TULSA will get FDA clearance for integration with the MAGNETOM Free.Max by early next year. We believe that we will meaningfully contribute to our growth in 2027. We aren't stopping TULSA image guidance at MRI. In May, Telix Pharmaceuticals announced a collaboration with us, as well as with a competitor that focuses on focal therapy.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Telix makes a PSMA PET imaging agent that bonds preferentially to prostate cancer and provides a clear view of the geographic location of cancer within the prostate. Our team is exploring the potential to integrate these types of PSMA images into the TULSA-PRO treatment planning software. Approximately 85% of prostate cancer is multifocal, meaning that there are two or more distinct index lesions and/or satellite lesions present in different areas of the organ. The other 15% is unifocal, meaning there is only one distinct index lesion. It follows that whole-gland and subtotal ablation is likely the most appropriate approach for the vast majority of prostate cancer that is multifocal, while focal ablation may be best for patients with unifocal disease. We are already seeing urologists use PSMA to complement MRI to better define treatment extent, with appropriate margins extending to the prostate capsule.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

For TULSA, this isn't about patient selection. It's about empowering physicians to plan and deliver the best possible renal ablation From whole-gland to focal and everything in between. To summarize, Profound is pioneering iMRI procedures which enable precise incisionless therapies that improve clinical confidence, procedural control, and patient outcomes. By leveraging real-time MRI guidance and autonomous robotics, Profound's technologies are designed to replace uncertainty with consistency and clarity across treatment planning, delivery, and confirmation. In prostate cancer, we believe we are now crossing the chasm by transitioning TULSA from early adopter customers to the mainstream market by establishing the technology as a third distinct regional ablation category that doesn't make surgeons or their patients choose between whole-gland or focal treatments, because TULSA can do both and anything in between. The TULSA-PRO install base was 84 at the end of Q2 2026.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

We estimate that the current aggregate total dollar value of our qualified sales pipeline for TULSA-PRO and Sonalleve is approximately S70 million. We are reiterating our approximate $25 million total revenue outlook for full-year 2026, which represents 56% growth compared to 2025. We also continue to expect full-year gross margin to be 70% or higher. Based on CMS proposed rules for 2027, the premium price rules are reimbursed for TULSA over all competing technologies is expanding. At the same time, more and more lives are being covered by other payers, including employer-owned health plans. We continue to believe that we are on a path to profitable growth. This ends our prepared remarks for today. With that, we are happy to take any questions you might have. Operator?

Operator

Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Ben Haynor of Lake Street Capital Markets. Your line is now open.

Ben Haynor
Senior Research Analyst at Lake Street Capital Markets

Good afternoon, gentlemen. Thanks for taking the questions. First off for me, just thinking about the $3.1 million that slipped from Q2 to Q3, is that both capital and consumables? Just generally speaking, how soon after quarter end did those units or product ship?

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Good afternoon, Ben. Good question. It was actually a consolidated shipment that went from Canada. The only reason it was not recognized is because we did not get all of the delivered receipts within the quarter timeframe. Some of them were in July. Pretty much everything has been sent. I think it sort of begs the second question is like, okay, how do we make sure this kind of stuff does not happen again?

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

I think that I can certainly provide a little bit of color on that in the sense that we have, since that time, increased our logistics and operating staff, and we are actually in the final stages of bringing a very experienced Vice President level operations person. This is part of our growing, as I said, it was a consolidated shipment. We didn't get all the receipts, so we didn't recognize it in Q3, but it most likely will be recognized in Q3.

Ben Haynor
Senior Research Analyst at Lake Street Capital Markets

To be on the $7 million of new orders, maybe you can share what the previous record was, and then obviously you had a great conference here recently with the 160 new qualified opportunities. Do you have a sense, based upon history, how quickly some of those can shake out into actual orders?

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

Ben, that's a great question, and I appreciate you asking it. As mentioned in the prepared remarks, very difficult to give a definitive answer. What I can tell you anecdotally is some of those leads have already materialized into deals that were not in our pipeline, that are already well down the funnel and into the negotiating contracting stage, which is extremely exciting. As is often said in the line of medical device sales, deals can take a year to develop and a day to dissolve, or they can take a day to develop and a year to complete. It completely runs the gamut. It really just time will tell, Ben.

Ben Haynor
Senior Research Analyst at Lake Street Capital Markets

Okay. Fair enough. On the penile, I guess unlengthening that you get with the robot, is there a plan to publish that data and maybe is it possible to characterize the range of outcomes there? I would think a lot of guys would care about the worst-case scenario rather than an average or median.

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

Hey, Ben. Yeah, thanks. This is Mathieu on the line. To answer your question directly, we are preparing that data as part of the broader picture of perioperative outcomes that we have released in the past, in Q1 and before that. To really package it together as a total sort of patient experience. On the surface, a difference of a few millimeters may not sound like a major outcome. However, for many men undergoing treatment for prostate cancer, literally every millimeter matters. The reason that penile shortening is not just a physical measurement, it can also serve as a constant reminder of both their cancer and the treatment that they underwent, which can affect their confidence, their emotional well-being, their intimate relationships, and overall satisfaction with treatment. We do view this result in the broader context of the CAPTAIN dataset.

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

In and of itself, penile length preservation is not the reason a physician or a patient may choose a treatment. However, when you combine this result with the previously reported superiority in preserving erectile function, urinary incontinence, as well as perioperative benefits of the no blood loss, no overnight stay, faster recovery, fewer major complications, it really paints a compelling picture of the overall patient experience. Really together, these outcomes highlight the potential for TULSA to deliver that effective cancer treatment while preserving quality of life. Ultimately, we believe the future of prostate cancer treatment will be driven not only by cancer control, but also by quality-of-life outcomes.

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

This penile length result is another example of how the TULSA procedure's ability to precisely ablate the prostate tissue while protecting surrounding structures can translate into benefits that matter to patients. As more of these quality-of-life data emerge, we do believe that this will increase the influence of patient preference, physician recommendations, and overall demand for treatments that do preserve the quality of life. On the topic of sort of the range, certainly there was a range. This is a non-conventional endpoint that we did include in the protocol. The way that they made the measurement has a median change and a range around that.

Ben Haynor
Senior Research Analyst at Lake Street Capital Markets

Okay. Got it. Well, thanks.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Ben, I have just a quick anecdote. There was actually a publication at the SRS where effectively its conclusion was that every millimeter counts for patients.

Ben Haynor
Senior Research Analyst at Lake Street Capital Markets

It makes sense. I believe there was an Italian study out there that showed some even greater impact for the robot.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah.

Ben Haynor
Senior Research Analyst at Lake Street Capital Markets

I'll leave it there, and congrats on the progress. Thanks for taking the questions.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Thank you, Ben.

Ben Haynor
Senior Research Analyst at Lake Street Capital Markets

Thanks, everyone.

Operator

Thank you. Our next question comes from the line of Michael Freeman of Raymond James. Your line is now open.

Michael Freeman
Michael Freeman
Research Analyst at Raymond James

Hi, Arun, Tom, Mathieu. A few questions following up on Ben's. I'm curious on the shipment timing challenge. We also saw that there was a shipment timing statement that you guys made in the first quarter indicating that six TULSA systems were shipped but not installed by the first quarter. I noticed that the incremental increase in TULSA installs was four quarter-to-quarter. Could you tell us just, I guess, what logistically or operationally is happening on these shipments? What challenges or delays maybe you're running into? I know you mentioned that you had hired on some extra staff to manage this. I wonder if you could just shed some light on this timing challenge.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Michael, I'm happy to do that. These are actually two different issues. The one related to rep rec in the second quarter is more about shipping to fulfill orders that we have received. Given that we did not get all the receipts, these have been recognized or we're recognizing today. It's more of a logistics issue from the perspective of shipment and so on. As I said, we're pretty much fixed already, so that's sort of an issue of the past. The other one that you're asking is actually once the product is shipped, it is installed, the site gets trained, they schedule patients, and so on.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

When we look at the install base, we're looking at sites actually treating patients. Normally there's a gap of a minimum of 60-120 days. It's based upon the scheduling of the hospital, the training programs, and their ability to start educating their customer population, so on. That is actually a separate issue. It is more about how do they actually convert the TULSA system into a treatment program and confirm all of their reimbursement and so on. I hope that answers your question from the perspective of the install base.

Michael Freeman
Michael Freeman
Research Analyst at Raymond James

Gotcha. Yeah, that is helpful. On the, and maybe a question for Tom, on the pipeline. Earlier you were quantifying the pipeline in terms of number of TULSA systems. Now we're talking about dollars in aggregate value and also splitting that between TULSA-PRO and Sonalleve. Are you able to give a number of new TULSA systems in your pipeline? And then I guess also shed some light on what proportion of Sonalleve sales might make up that $70 million aggregate value.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

Michael, great questions. Thank you for asking them. I'll tackle the last question first then work my way to the beginning of your commentary. What I can tell you is that in terms of the $70 million that fall within the verify, negotiate, and contract categories of the sales funnel, it's roughly a 70%/30% split between the United States and international in terms of dollars forecasted within those respective categories. As it relates to TULSA-PRO versus Sonalleve, it's roughly a 90% TULSA-PRO, 10% Sonalleve split. The reason that we have moved away from providing what I would consider to be units versus dollars is we want to stay focused on maximizing top-line revenue and gross margin and growing TULSA programs and Sonalleve programs versus simply installing systems.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

That's one of the major reasons we've obviously introduced the Index 20 as well, is that we want to get to the point, as we've messaged before, where we have 200 TULSA-PRO systems installed and treating men across the world with an average of 50 men per year. That would allow us to treat over 10,000 men per year. I hope that answers the question that you had, and I'm of course, happy to answer any follow-up questions based on what I just responded with.

Michael Freeman
Michael Freeman
Research Analyst at Raymond James

Yeah. That is really helpful. Let's see. Arun shed some light on the decline in the TULSA utilization index. I wonder if you could just speak more about those sites that ran into temporary issues and then also the trends you are seeing. You mentioned good numbers in July.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah. Tom, since it was in your presentation, if you could just provide more color on that topic.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

Of course. Michael, thank you for bringing it up. Obviously, there is a lot being presented within the Index 20, and we are excited to share it. I just want to reiterate what I stated in the prepared remarks and then provide some more color on that. While we did see the decline by 12% in terms of sequential quarter-over-quarter growth, we did see an increase of 39% in the first six months of 2026 versus the first six months of 2025, and a 22% increase in Q2 2026 compared to Q2 2025. In terms of the main drivers of that, there were five sites in particular that did not grow as we expected them to do due to short-term issues.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

To give some color to the example that was called out in the prepared remarks, in different countries, in different independent distribution networks or health systems, they have different policies. For instance, if we're required to come in on a placement model, that placement model normally has a set period of time and a set number of metrics and milestones that need to be completed. After that point in time, they literally stop the program until they complete the process of determining whether they're going to acquire the technology. In this instance, it's actually a high-class problem.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

We were successful with the placement. The timeline associated with that agreement had come to close, and there was a gap of a certain period of time between when that placement ended and when the capital acquisition actually took place. With our modeling, it's beneficial to the hospital to go to the capital ownership model because that lowers the cost per procedure as it relates to the TULSA-PRO kits. All in all, it's a net positive, but clearly not impactful as it relates to speaking to quarter-over-quarter sequential growth.

Michael Freeman
Michael Freeman
Research Analyst at Raymond James

Gotcha. All right. Thank you very much for this color. I'll pass it on now.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

Thank you, Michael.

Operator

Thank you. Our next question comes from Scott McAuley with Paradigm Capital. Your line is open.

Scott McAuley
Scott McAuley
Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital

Thanks. Afternoon, everyone. Thanks for taking the questions. Maybe just to circle back on some of Michael's questions. The install base versus units sold. Correct me if I have this wrong, but if you have 84 installed as of the end of Q2, there's 80 installed by the end of Q1, that's net four new in the quarter. If from the end of Q1, there were six units that had been sold but not installed, does that mean there's still two more from that Q1 period that haven't been installed and up and running yet? Versus net new sales in Q2. I understand it can be kind of confusing. Just looking for a little more color on?

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah

Scott McAuley
Scott McAuley
Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital

Some of those numbers.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah. Scott, I think the way you've analyzed it is exactly right, that we shipped six systems in Q1. Four of them were installed in Q1. Two of them are still in the process. We've shipped about the same number in Q2, as you've already heard the logistics thing. We are continuing to install more sites, Q3, you will again see an increase in the install base. That you have analyzed the numbers is exactly right.

Scott McAuley
Scott McAuley
Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital

Got it. In terms of that pipeline of getting from the sale to the install, I think that's 60-100 days you had referenced the-

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah

Scott McAuley
Scott McAuley
Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital

your work on.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

That's-

Scott McAuley
Scott McAuley
Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital

I know it's a lot out of your hands, but trying to accelerate that.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah. We are continuing to grow our teams in every key department. I do think that over time, those numbers will continue to drop. That has been sort of It used to be higher than that. It used to be kind of six months. Now it's indeed less. I also think that, as Tom described the momentum that we are building at SRS, I think people are beginning to sort of see that, hey, this is the next thing. That is automatically adding to a bit of a sense of urgency in multiple sites.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

I do think that over time, that number will shrink far closer to 60 days than it is today. I think to your point on number of sites and so on, and Tom described that we're moving more towards a pipeline that is described in dollars. I do sort of think that one of the early indicators that we are gaining confidence in our pipeline is the fact that Q2, from a number of purchase orders point of view, in dollars, was actually the best quarter we've ever had. I think that is a tangible data that sort of says that, hey, this pipeline that we're now dollarizing is very real.

Scott McAuley
Scott McAuley
Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital

Absolutely. No, that's helpful. Maybe again on circling back on that pipeline question, I understand wanting to present it in dollars versus necessarily units. Is there any way you can kind of quantify how that pipeline's expanded or grown from that initial number of units versus dollar amount? Any other color there?

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah. I don't have an exact number for you. Again, as you heard from Tom, at the SRS, we have 160 leads. Q1 also, in terms of new leads, was I'm sorry, Q2 was also a very good quarter. We are dollarizing. We are going to start qualifying and making sure that that earlier pipeline that we just built is also added to this. Most certainly, this number is probably 30%-40% higher than what we have been looking at before. We sort of feel like if you go and say 100 sites versus a dollar amount, we just think once you get beyond 100, it just becomes far less meaningful, and a dollar number becomes more meaningful. That's the only reason for using the dollars.

Scott McAuley
Scott McAuley
Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital

Yeah. Definitely. That makes sense. Maybe lastly on the team and the operations side of things, I think it's mentioned in the press release that the operating costs actually went down relative. I may or may not have that right. As you had highlighted, bringing on new operations people, potentially expanding the team to help get these installations in faster and obviously dealing with the expanded pipeline. Any comments on how you see operating costs scale in the next few quarters? Obviously, kind of move in lockstep with revenue growth. How do you see that expense side of the?

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah

Scott McAuley
Scott McAuley
Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital

Income statement growing in the next few quarters?

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah. Great question, Scott. There are several things about this. First of all, I do think that it does speak to the leveragability of our product, because good high dollar amount in revenue for the capital, very good dollar amounts per patient on the utilization part, and a good high margin. I do think that it is important to recognize that we are not just looking to be a growth company at any cost. We actually think that as the revenues come in, that we are going to be heading more and more towards profitable growth. I think that's a very important part of our strategy. The second thing is that your point is exactly right, is that we are adding resources as we go.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

We need to, because obviously we are very careful with the expenses, but we need to, and I think that there will not always be complete sync in more people added and higher revenue in every quarter. I agree with you that you will probably see a little bit of an up and down in a quarter here and there. Again, I think, as we see in the utilization side at this stage, if you begin to look at it as a half-yearly perspective, I think you will begin to see a trend, as the cost will grow as close as possible to the growth of the revenue for us. Again, just to be clear, you're exactly right, that there will be some up and down. I think on a bigger time interval, you will begin to see a trend that will be on the growth and the potential profitability.

Scott McAuley
Scott McAuley
Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital

That's great, Arun. Really appreciate the color and that's all from me for now.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Beautiful. Thank you, Scott.

Operator

Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our next question comes from the line of Kyle Bauser of Titan Partners. Your line is open.

Kyle Bauser
Director and Senior Healthcare Analyst at Titan Partners

Great. Thank you for taking my question. Maybe on the sales guidance, are you assuming a certain amount of additional payer coverage policies this year? Also, do you have a total number of covered lives to date? I know it was up 18.3 million in this last quarter and up 8.5 million in Q1. Just wondering if you have a total running number.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yes. Good afternoon, Kyle. To answer your first question, the answer is yes. We are continuing to work with insurance companies. On a routine basis, almost every day we see that patients who apply for reimbursement, even with insurance companies that don't have coverage policies and more and more are beginning to get reimbursed. I think based upon that, we certainly expect that the number of covered lives will continue to increase. Mathieu, I don't have the full number offhand. Do you have the full number of the 18 plus what we reported in the first quarter?

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

Are you asking me in the first quarter in terms of covered lives?

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yeah.

Mathieu Burtnyk
Mathieu Burtnyk
President at Profound Medical

I think it was in the 8.5 million.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

I think in whole numbers, Kyle, we're close to 30 million, maybe 29 million, but we're close to 30 million.

Kyle Bauser
Director and Senior Healthcare Analyst at Titan Partners

Okay. Including Medicare as well.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

No, that does not include Medicare.

Kyle Bauser
Director and Senior Healthcare Analyst at Titan Partners

Yeah.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Medicare is on top of that. Yeah.

Kyle Bauser
Director and Senior Healthcare Analyst at Titan Partners

Yep. Got it. Okay. Just Medicare on top of the Q1 and Q2 numbers. That makes sense. Got it.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Yes.

Kyle Bauser
Director and Senior Healthcare Analyst at Titan Partners

Great. You've talked about, extensively and during this call, how compelling the data out there is resonating with physicians, particularly with the CAPTAIN results earlier this year, showing TULSA's clear benefit over robotic RP across ED, continence, and recovery. I guess on the patient side, in your assessment, be curious to understand how involved the patients are when it comes to defining a treatment path. It just would seem like TULSA would be kind of a no-brainer here given the superior quality of life outcomes. Just any color around this would be helpful.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Let me just state a couple of things, Tom, if you could please chime in also. To your first point regarding the CAPTAIN trial and the conversations that we're beginning to have with urology community, I think the most interesting part to me has been the dialogue around the concept of trifecta. What is trifecta? Trifecta is cancer outcome, erectile dysfunction, and incontinence. The reality is that in some ways, all three of these things are kind of connected. If you remove more prostate, you probably have a little better clinical outcome, but you have higher likelihood of incontinence or erectile dysfunction.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

I think the most interesting conversation that we're beginning to have with the urology community, we find them to be very receptive to this way of thinking about it, is that I think that what we're beginning to see that if you evaluate it on a trifecta basis, statistically the population that is in the trifecta of the robotic surgery versus the population that is in the TULSA arm, we think they are absolutely separate and there's more flexibility. I think talking to urologists in the language that they already use like this is one of the things that we find very satisfying. I'll turn it over to you from the perspective of the patient.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

Thank you, Arun, excellent question, Kyle. Thank you for asking it. I wanted to glean off of what we experienced at the Society of Robotic Surgery, Arun and Mathieu, which was arguably the most successful medical conference I've attended, whether that was at LifeCell Corporation, Novadaq Technologies, or here at Profound. We not only had the opportunity, of course, to meet with the 4,000+ physicians from around the world who were in attendance, but as Arun mentioned, we got to meet with the founders of the Society of Incisionless Surgery, which we plan to be a big part of at their inaugural meeting in February of 2025.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

There were also men that we spoke with who were courageous enough to confide that they were prostate cancer patients or survivors, and to share, with great vulnerability, the struggles that they've been through related to complications they've experienced from the treatments they've endured. I think we'd be remiss not to mention the mental health impact that men who get diagnosed with prostate cancer are subjected to, not only with the diagnosis, but the stress and the anxiety and the unknown of what treatment to select, because it's the first time they've gone through it, and hopefully the last time. Part of what we have done here at Profound is we've launched a global patient advocacy group called Let's Huddle, and that's led by Leonard Wheeler, who is a prostate cancer survivor and a TULSA-PRO patient. That group is not meant to promote TULSA-PRO.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

It's meant to promote awareness around men's health, in particular prostate health and mental health. On a monthly basis, Leonard hosts a group of men who can join from all over the world and provides open space for peer-to-peer conversation. What I can tell you from having the privilege to participate in that, the last go-around in July, unfortunately missed today's session, which was here in August, this afternoon Eastern time, was that we had men on who were authors of books regarding facing prostate disease, men who have blogs with hundreds of thousands of followers, men who have consulting agencies that are literally built around educating other men how to take on their prostate disease journey. Personally, I'm most excited about raising the awareness around men's health, both prostate health and mental health, because they go hand in hand.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

What really took place at SRS, in my opinion, is that the conversation that's being done behind a consulting room door inside of an office is now happening on the podium in the audience amongst the men and women providing prostate disease treatment. We're forcing the dialogue the same way that women forced the dialogue around breast cancer diagnosis, treatment, and reconstruction. Women were subjected to total mastectomies, radical mastectomies, where they had their breasts removed, they had their pec removed, and all they were left with was a flat chest wall. Now, when women go through a breast reconstruction, depending on the stage of the cancer, the results of their reconstruction rival that of an augmentation for cosmetic reasons.

Tom Tamberrino
Tom Tamberrino
Chief Commercial Officer at Profound Medical

I truly believe all of us on the phone that are men and caregivers of men, we need to start the rallying cry, whether it's Profound or the other folks that offer interventions for men's prostate disease, that men should be aware, they should have access, and they should be empowered to make the decision with their clinician based on their clinical presentation and what's important to them as it relates to quality of life, sexual function, urinary incontinence, penile length, mental health. I apologize for the emboldened response, but I truly believe we're at an inflection point here in men's healthcare, and we've got to get louder. Thank you for asking the question.

Kyle Bauser
Director and Senior Healthcare Analyst at Titan Partners

Got it. No, agreed, very helpful. Thank you for that. Maybe just one more question, if I may. We saw in the RP arm in the CAPTAIN trial that about 33% of patients had positive surgical margins. Any more specific timing estimate for later this year around when we'll see the TULSA procedure histology and imaging for the, I think, 12-month biopsying MRI results to kind of quantify surgical margins?

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Kyle, we are still in the process of collecting all the final data. We have a vast majority of the patient data in, but we're not all the way there yet. We are still very comfortable that sometime in Q4, we should be able to get the whole TULSA arm information out [inaudible] data. I would still like to point out that in the TULSA arm, it's biopsy, which is the gold standard of how we're measuring, and it's very detailed, versus in the robotic arm, it is basically measuring positive margins, which is very much simpler and far less comprehensive.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Most of the patients who underwent the robotic arm underwent what they call nerve-sparing prostatectomy. Again, coming to that point about the trifecta, you're seeing 35% positive margins, and you're actually seeing a little bit better than what you see in other studies on the erectile dysfunction. We do think that we're in a pretty good position with respect to particularly the trifecta. Kyle, to give you the answer, I think most certainly you're on track with getting the information out in Q4.

Kyle Bauser
Director and Senior Healthcare Analyst at Titan Partners

Got it. Okay, great. Very helpful, and thank you for taking my question.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Thank you, Kyle.

Operator

Thank you. This concludes the question-and-answer session. I would now like to turn it back to Dr. Menawat for closing remarks.

Arun Menawat
Arun Menawat
CEO and Chairman at Profound Medical

Thank you so much, and thank you for all the analysts for their questions. Hopefully we've answered them comprehensively for you. Look forward to similar dialogue in Q3. Thank you.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Executives
    • Stephen Kilmer
      Stephen Kilmer
      Investor Relations Contact
    • Matthew Sobczyk
      Matthew Sobczyk
      Corporate Controller
    • Mathieu Burtnyk
      Mathieu Burtnyk
      President
    • Tom Tamberrino
      Tom Tamberrino
      Chief Commercial Officer
    • Arun Menawat
      Arun Menawat
      CEO and Chairman
Analysts
    • Ben Haynor
      Senior Research Analyst at Lake Street Capital Markets
    • Michael Freeman
      Research Analyst at Raymond James
    • Scott McAuley
      Head of Research and Analyst and Healthcare and Biotechnology at Paradigm Capital
    • Kyle Bauser
      Director and Senior Healthcare Analyst at Titan Partners
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