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Profound MedicalA
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2026-08-13
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Investor releaseQuarter not tagged2026-08-13

Profound Medical (PROF) Q2 2026 Earnings Call Transcript

Motley Fool
Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Chief Executive Officer and Chairman - Arun Swarup Menawat President - Mathieu Burtnyk Chief Commercial Officer - Tom Tamberrino Corporate Controller - Matthew Sobczyk Investor Relations - Stephen Kilmer Operator: Good day, and thank you for standing by. Welcome to ProFound Medical's Second Quarter 26 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 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: 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 expressed 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 Arun Swarup Menawat, Co-Founder's Chief Executive Officer and Chairman Doctor. Mathieu Burtnyk, Profound's President and Tom Tamberrino, our Chief Commercial Officer. Also filling in for our CFO, Rashed due to a scheduling issue is our Corporate Controller, Matthew Sobczyk. With that said, I will now tu…Read full document

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Chief Executive Officer and Chairman - Arun Swarup Menawat President - Mathieu Burtnyk Chief Commercial Officer - Tom Tamberrino Corporate Controller - Matthew Sobczyk Investor Relations - Stephen Kilmer Operator: Good day, and thank you for standing by. Welcome to ProFound Medical's Second Quarter 26 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 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: 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 expressed 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 Arun Swarup Menawat, Co-Founder's Chief Executive Officer and Chairman Doctor. Mathieu Burtnyk, Profound's President and Tom Tamberrino, our Chief Commercial Officer. Also filling in for our CFO, Rashed due to a scheduling issue is our Corporate Controller, Matthew Sobczyk. With that said, I will now turn the call over to Arun. Arun Swarup Menawat: Good afternoon, everyone. And welcome to the second quarter 26 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. Matthew Sobczyk: I will turn the call over to Mathieu in a moment to provide clinical updates. However, before I do, I would like to provide a brief summary of our second quarter 26 financial results. All of the numbers I will refer to have been rounded. So they are approximate. For the 3 month period ended June 30, 2026, the company recorded revenue of $2.5 million with $1.6 million from recurring revenue and $871 thousand from capital equipment sales. Second quarter 26 revenue was up 12% from $2.2 million for the same 3 month period a year ago. As noted in today's press release, this does not fully reflect our sales performance in Q2 2020. $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 a 153% year over year growth. Gross margin in Q2 2020 was 78% compared to 73% in Q2 2020. 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. Total operating expenses in the second quarter of 2026 were $13 million down 16% from the $15.4 million in the second quarter of 2025. 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 3 months ended June 30, 2025. As of June 30, 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. Mathieu Burtnyk: With that, I will now turn the call over to Mathieu Burtnyk, for an update on clinical and development activities. Thank you, and good afternoon. On past calls, I have 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 6 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. 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 1 month following the Tulsa procedure, there was no median change in penile length after Tulsa compared with a median 0.65-centimeter 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. As we noted before, 1 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 make TULSA most versatile. 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 1 side of the prostate and whose nerves that maintain erectile function can be spared by not ablating the benign side of the prostate. 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 would like to conclude my remarks by reiterating that some gold standard treatment findings, detect durable 5-year outcomes, generating compelling Level 1 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. Thomas Tamberrino: I will now turn the call over to Tom. Thank you. there is 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 5 sites not realizing the expected growth due to short term issues. For example, 1 of the sites converted from a placement to a capital model in Q2, and paused treatments during the transition. That site is now back online. Despite these onetime and or temporary issues, Q2 2026 marked another true commercial inflection point. And so far, we have seen that momentum continue into Q3. We estimate that our qualified sales pipeline defined as being within 1 of the verify, negotiate and contracting stages, for TULSA PRO and Sonali is now $70 million While we cannot predict the extent and/or timing with 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. And SRS-26 was the most productive medical meeting I have ever been a part of. To put that into perspective, our team's work generated more than 160 qualified leads over the 4 days of the event, So around 4 or 5 new commercial opportunities per hour. Again, it is not possible to predict what number of those will translate into actual sales. But also, again, boding well for the future. 3 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, Talsa remains at urology APC Level 7, with OPPS payment increasing 14.9% to $15.5 thousand per procedure. That compares to an 11.6% increase for HIFU and Aquablation to $10.8 thousand and $12.3 thousand for Robotic RP. So, assuming the final rule does not change these numbers, starting in January 2027, hospitals would pay 44% or $4.7 thousand more per procedure for Tulsa than HIFU and Aquablation. and 26% or $3.19 thousand 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 $6.87 thousand However, we do not 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 driven 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. Adjusting for the fact that Tulsa is 0-day, while competitors are 90-day, physicians will be paid $880 for each TULSA procedure compared to $865 for HIFU, $1.06 thousand 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 similar programs. This follows the addition of 8.5 million covered lives in the first quarter, which included 6.9 million covered lives with Humana. And just today, we announced that the John Hopkins and the Prime Healthcare employee health plans together covering more than 105 thousand employees, medical staff and family members become the first ever employer owned health plan to list the TULSA procedure as a covered service. And we are just getting started. 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 am confident in our ability to further accelerate. We are well positioned to capitalize on the expanding interest in image guided incisionless and autonomous robotic surgery. We are anticipating an extended reimbursement premium for Tulsa hospitals and physicians, We are growing an already formidable body of evidence demonstrating the superiority of our technology and we are continuing to scale our commercial footprint, both at home and abroad. Thank you for your time. I will turn the call over to Arun now. Arun Swarup Menawat: Thanks, Tom and 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. Open, robotic prostatectomy or radiation therapy, are the standard of care. For treating prostate cancer today. And 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. And that we can do better than the clinical outcomes from these standards. Just a few days ago, at SRS 26, 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. TULSA is the only modality that offers the flexibility to treat the prostate gland regionally, meaning with whole-gland or near-gland, subtotal, 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 FIS, began its activities at FRS 26. And ProFound, HistoSonics and InsightSAC, are among the most prominent founding members of the new society. And 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 persons to deliver consistent highly personalized treatment based on each patient's unique anatomy and disease. In the future, it may also give us an even stronger competitive advantage as incisionless surgery advances to its next frontier, including potentially tele-ablation. 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 program was a hurdle to climb. But today, TULSA is compatible with an installed base of about 5 thousand MRs in The United States, and more worldwide and that number continues to grow. 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 and based on the proposal 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. And 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 do not need the same shielding as larger magnets. The Siemens Free.Max series which is a prime example of such an MR. Hook 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 are robotic operating rooms, were created in the past The future is about creating interventional MR suites. We currently anticipate that if all goes well, TULSA will get FDA clearance for integration with the Siemens Free.Max by early next year, And we believe that we will meaningfully contribute to our growth in 2027. And we are not stopping with TULSA image guidance at MRI. In May, Illuccix Pharmaceuticals announced a collaboration with us as well as with a competitor that focuses on Focal therapy. Illuccix, 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 2 or more distinct index lesions and or satellite lesions present in different areas of the organ. The other 15% is unipocal. Meaning there is only 1 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. So for TULSA, this is not about patient selection. it is about empowering physicians to plan and deliver the best possible regional 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 lets physicians or 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. We estimate that the current aggregate total dollar value of our qualified sales pipeline, for TULSA PRO and Sonalleve is approximately $70 million. We are reiterating our approximate $25 million total revenue outlook for full year 2026. Which represents 56% growth compared to 2025. And we also continue to expect full-year gross margin to be 70% or higher. Based on CMS proposed rule for 2027. The premium hospitals are reimbursed for TULSA over all competing technologies is expanding And 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: At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press 11 on your telephone, and wait for your name to be announced. To withdraw your question, please press 11 again. Please stand by. First question comes from the line of Ben Haynor of Lake Street Capital Markets. Your line is now open. Ben Haynor: Good afternoon, gentlemen. Thanks for taking the questions. First off, for me, just thinking about the $3.1 million that slipped from Q1 to Q or Q2 to Q3, Is that both capital and consumables? And then just generally speaking, how soon after quarter end did that did those units or product ship? Arun Swarup Menawat: Good afternoon, Benjamin. Good question. So it was actually a consolidated shipment that went from Canada. And the only reason it was not recognized is because we did not get all of the you know, delivered receipts. Within the quarter time frame. So with some of them, you know, they were in July. So pretty much everything has been sent. And I think you know, it sort of begs the second question. it is like, okay. How do we make sure this kind of stuff does not happen again? And 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. And so this is you know, part of our growing And it was, you know, as I said, it was a consolidated shipment. We did not get all the receipts, so we did not recognize it. in Q3, but it is Most likely will be recognized in Q3. Ben Haynor: $7 million of new orders Maybe you can share what the previous record was and then, you know, obviously, you have had I had a great conference here recently with the 160 new qualified opportunities. Do you have a sense based upon history, kind of how quickly some of those can shake out into actual orders? Thomas Tamberrino: And that is a great question. And I appreciate you asking it. As mentioned in the prepared remarks, very difficult to give a definitive answer. But 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 and contract stage, which is extremely exciting. As is often said in the line of medical device sales, you know, 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. So it completely runs the gamut. So it really just time will tell, Benjamin. Ben Haynor: Okay. Fair enough. And then on the penile, I guess, shortening that you get with the robot, is there is there a plan to publish that data and maybe is it possible to characterize the range of outcomes there? I mean, I would think a lot of guys would care about the worst case scenario rather than you know, an average or median. Mathieu Burtnyk: Hey, Benjamin. Yeah. Thanks. This is Mathieu on the line. So to answer, you know, your question directly, the we are preparing that data as part of the broader picture of perioperative operative outcomes that we have released in the past. In Q1 and before that. And so to really package it together as a total sort of patient experience, On the surface, you know, 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. So we do view this result in the broader context of the CAPTAIN dataset. 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 resolve with the previously reported superiority in preserving erectile function, urinary incontinence, as well as the pure 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. And, really, together, these outcomes highlight the potential for Tulsa to deliver that effective cancer treatment while preserving quality of life. So, ultimately, we believe the future prostate cancer treatment will be driven not only by cancer control, but also by quality of life outcomes. And 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. And 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, I mean, certainly, was a range. This is a non conventional endpoint that we did include in the protocol. And, you know, so the way that the measurement made, the measurement has a medium change and a range around that. Arun Swarup Menawat: Okay. Okay. Got it. Then, well, I have just a quick think just a quick anecdote. There was actually a publication at the SRS where you know, effectively, its conclusion was that every millimeter counts for patients. Ben Haynor: Yeah. I mean, it makes sense. I believe there was an Italian study out there that showed some even greater impact for the robot. But I will leave it there, and, congrats on the progress. Thanks for taking the questions. Arun Swarup Menawat: Thank you, Ben. Thanks a lot. Operator: Our next question comes from the line of Michael Freeman of Raymond James. Your line is now open. Michael Freeman: Hi, Arun. it is Matthew. Matthew. A few questions following up on Benjamin. So I am curious on the on the shipment timing challenge. Like, we also saw that there was a shipment timing statement that you guys made in the first quarter indicating that 6 TULSA systems were shipped but not installed by the first quarter. And noticed that the incremental increase in TULSA installs was 4. Quarter to quarter. Could you tell us just I guess, what logistically or operationally is happening on these on these shipments? Like, what challenges or delays maybe you are running into? And I know you mentioned that you had hired on some extra staff to manage this. So I wonder if you could just shed some light. On this timing challenge. Arun Swarup Menawat: Michael, I am happy to do it. So these are actually 2 different issues. The 1 related to rev rec in the second quarter is more about shipping to fulfill orders that we have received. And given that we did not get all the receipts either did not recognize but will recognize in Q3. so it is it is more of a logistics issue from the perspective of shipment and so on. And as I said, we are you know, we are pretty much fixing. Already. So that is sort of an issue on the past. The other 1 that you are asking is actually once the product is shipped it you know, it is installed, the site gets trained They schedule patients and so on. So then when we look at the install base, we are looking at sites actually treating patients. And normally, there is a gap of a minimum of 60 days to a hundred and 20 days it is based upon the scheduling of the hospital, the training programs, and their ability to start educating their customer population, so on. So that is actually a separate issue. It is more about, you know, how do they actually convert the TULSA system into a treatment program and you know, confirm all of their reimbursement and so on. So I hope that answers your question. From the perspective of the install base. Michael Freeman: Gotcha. Yep. that is that is helpful. Now on the maybe a question for Tom. On the on the pipeline, you know, we have earlier, you were quantifying the pipeline in terms of number of Tulsa systems. Now we are talking about dollars in aggregate value and also and also splitting that between TULSA and Sonalleve. I wonder are you able to give a number of new TULSA systems? In your in your pipeline? And then and then, I guess, also, shed some light on what proportion of Sonalleve sales might make up that 70 million aggregate value. Thomas Tamberrino: Michael, great questions, and thank you for asking them. I will tackle the last question first and 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 is roughly a 70%-30% split between The United States and international. In terms of dollars. Forecasted within those respective categories. And then as it relates to Tulsa Pro versus Sonalleve, it is roughly a 90% TULSA PRO, 10% Sonalleve split. And the reason that we have moved away from providing what I would consider to be, you know, 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. And that is 1 of the major reasons we have obviously introduced the index 20 as well. Is that we want to get to the point as we have messaged before where we have 200 TULSA Pro systems installed and treating men across the world. With an average of 50 men per year, and that would allow us to treat over 10 thousand men per year So I hope that answers the question that you had. And I am, of course, happy to answer any follow-up questions based on what I just responded with. Michael Freeman: Yeah. Yeah. that is that is really helpful. Let's see. And then you did Arun shed some light on the decline in the utilization index. the utilization index. I wonder if you could just speak more about, about those sites. That ran into temporary issues and then also the trends you are seeing You mentioned there were good numbers in July. Yeah. Actually, Tom said was in his presentation, if you could just provide more color on that topic. Thomas Tamberrino: Of course, Michael. Thank you for bringing it up. Obviously, there is there is a lot being presented within the index 20, and we are excited to share it. And I just wanna reiterate what I stated in the prepared remarks and then provide some more color on that. So 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 6 months of 2026 versus the first 6 months of 2025. And a 22% increase Q2 26 compared to Q2 25. In terms of the main drivers of that, there were 5 sites in particular that did not grow as we expected them to do due to short term issues. To give some color to the example that was called out in the prepared remarks, in different countries and different industry independent distribution networks or health systems they have different policies. For instance, if we are 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 And after that point in time, they literally stop the program until they complete the process of determining whether they are going to acquire the technology. So in this instance, it is actually a high class problem. 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. And with our modeling, it is 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. So all in all, it is a net positive. But clearly not impactful as it relates to speaking to quarter over quarter sequential growth. Michael Freeman: Got you. All right. Thank you very much for this color. I will pass it on now. Arun Swarup Menawat: Thank you, Michael. Thomas Tamberrino: Thank you. Operator: Our next question comes from Scott McAuley with Paradigm Capital. Your line is open. Scott McAuley: Thanks. Afternoon, everyone. Thanks for taking the questions. Maybe just to circle back on some of Michael's questions. So the install base versus units sold, so correct me if I have this wrong, but so if you have 84 installed as of the end of Q2, there is 80 installed by the end of Q1. So that is net 4 new in the quarter. But if from the end of Q1, there were 6 units that had been sold but not installed, So does that mean there is still 2 more from that Q1 period that have not been kind of installed and up and running yet? And then versus kind of net new sales in Q2 Like, I understand it You know? It be kind of confusing. So just looking for a little more color on some of those numbers. Arun Swarup Menawat: Yeah. Scott, I think the way you have analyzed it, is exactly right. We shipped 6 systems in Q1 4 of them were installed in Q1. 2 of them are still in the process We have shipped about the same number in Q2 as I or you already heard the logistics thing. But you know, we are continuing to install more sites and so Q3, you will again see an increase in the install base. So that you have analyzed the numbers is exactly right. Got it. Scott McAuley: And in terms of that pipeline of you know, getting the from the sale to the install, You know, I think that is 60 to a hundred days you would referenced the work on. that is I know it is a lot out of your hands, but trying to trying to accelerate that. Arun Swarup Menawat: Yeah. And, you know, we are continuing to grow our teams in every key department. And I do think that over time, those numbers will continue to drop. But that has been-- it used to be higher than that. Used to be kind of 6 months. But now it is indeed less. And I also think that you know, as described the momentum that we are building in you know, at SRS. I think people are beginning to sort of see that, hey. This is the next thing. And that is automatically adding to a bit of a sense of urgency in multiple sites. So I do think that over time, that number will shrink far closer to 60 days than it is today. And I think to your point, on number of sites and so on, and, you know, Tom described that we are moving more towards a pipeline that is described in dollars. But I do sort of think that it that 1 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 have ever had. So I think that, like, is a tangible data that sort of says that, hey, you know, this is this pipeline that we are not dollarizing is very real. Scott McAuley: Absolutely. No. that is that is helpful. And maybe, again, on circling back on that pipeline question, and I and I understand wanting to present it in dollars versus necessarily units. Is there any way you can kind of quantify how that pipeline expanded or grown from that initial number of units versus dollar amount. Any other color there? No. Arun Swarup Menawat: Yeah. You know, we I do not have an exact number for you. But you know, again, as you heard from Tom, at the SRS, We have 160 leads. Q1 also in terms of new leads was up I am sorry. Q2 was also very good quarter. So we are dollarizing. We are going to start qualifying and making sure that earlier pipeline that we just built is also added to this. But most certainly, this number is probably 30%-40% higher than what we have been have been looking at before. We you know, we sort of feel like if you go and say, how many sites versus a dollar amount. We just think once you get beyond 100, it just becomes far less meaningful. A dollar number becomes more meaningful. that is the only reason for using the dollars. Scott McAuley: Yep. Definitely. That makes sense. And maybe lastly, the, you know, on the team and the you know, operations side of things, I think it is mentioned in the press release that the operating costs actually went down relative. I may or may not have that right. But as you highlighted, you know, bringing on new operations people, potentially expanding the team to help get these installations in faster and obviously dealing with the expanded pipeline. Kind of any comments on how you see operating costs, you know, scale in the next few quarters? And obviously kind of move in lockstep with revenue growth, but, kind of how you see that expense side of the income statement going in the next few months? Arun Swarup Menawat: Great question, Scott. Know, there are several things about this. First of all, I do think that it does speak to the leverage ability of our product. Because, you know, good high dollar amount in revenue for the capital very good dollar amount per patient on the utilization part at a good high margin. So 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. And I think that is 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. We need to because obviously, we are very, very careful with the expenses. But we need to. And I think that they will all not always be in complete sync in, you know, more people added and higher revenue in every quarter. So I agree with you that you will probably see a little bit of an up and down in a quarter here and there. But, again, I think as we see in the utilization side at this stage, if you begin to look at it as a, you know, half-year, first half year and new perspective, I think you will begin to see a trend. As the cost grow that the cost will grow you know, as close as possible to the growth of the revenue for us. So you know, again, just to be clear, you are exactly right. There will be some up and down. But I think on a bigger time interval, you will begin to see a trend. That will that will be on growth and the potential profitability. Scott McAuley: that is great, Arun. I really appreciate the color, and that is all for me for now. Arun Swarup Menawat: Beautiful. Thank you, Scott. Operator: Thank you. As a reminder, to ask a question, you will need to press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Our next question comes our next question comes from the line of Kyle Bauser of TI Partners. Your line is open. Analyst: 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 And then, also, do you have a kind of 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 kind of total running number. Arun Swarup Menawat: 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, you know, almost every day. We see that patients who apply for reimbursement, even with insurance companies that do not have coverage policies and more and more are beginning to get reimbursed. So I think based upon that, we certainly expect that the number of covered lives will continue to increase. Mathieu Burtnyk: Mathieu, I do not have the whole full number off hand. Do you have the full number? Arun Swarup Menawat: Oh, the 18 plus what we reported in the first quarter. Are you asking me in the first quarter in terms of covered lives? Yeah. I think it was in the 8.5 million. So I think in whole numbers, I believe we are close to 30 million, maybe 29 million, or we are close to 30 million. Okay. Including Medicare, as well? But, no, that does not include Medicare. Yeah. Medicare is on top of that. Yeah. Yep. Got it. Okay. So just Medicare on top of the Q1 and Q2 numbers. That makes sense. Got it. Yeah. Great. And then, you have talked about you know, extensively and during this call, how compelling the data out there is resonating with physicians. You know, particularly with the CAPTAIN result here. And, you know, showing Tulsa's clear benefit over robotic RP. You know, across ED, continents, and But I guess on the patient side, in your assessment, be curious to understand, you know, how involved the patients are when it comes to defining a treatment path. I mean, it just would seem like TULSA would be kind of a no-brainer here given the superior quality of life outcomes. So I am just you know, any color around this would be helpful. Yeah. So let me just state a couple of things, and then, Tom, if you could please chime in also. So, you know, to your first point regarding the CAPTAIN trial and the conversations that we are beginning to have with you know, urology community I think the most interesting part to me has been the dialogue around the concept of trifecta. So what is trifecta? Trifecta is you know, cancer outcome, erectile dysfunction, and incontinence. And the reality is that in some ways, all 3 of these things are kind of connected. You know, if you remove more prostate, you probably have a little better clinical outcome, but you have higher likelihood of incontinence or erectile dysfunction. And I think the most interesting conversation that we are beginning to have with the urology community in and we find them to be very receptive to this way of thinking about it. Is that I think that what we are beginning to see that if you evaluate it on a trifecta basis, you know, 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 is more flexibility. And I think talking to urologists in the language that they already use like this is 1 of the things that we find very, very satisfying. I will turn it over to you from the you know, perspective of the patient. Thomas Tamberrino: Thank you, Arun, and excellent question, Kyle. Thank you for asking it. I wanted to glean off of what we experienced in Society of Robotic Surgery, Arun and Matthew. Which was arguably the most successful medical conference I have attended, whether that was at LifeCell Corp., NOVADAQ Technologies, or here at ProFound. And we not only have the opportunity, of course, to meet with the 4 thousand-plus 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 2025. But 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 have been through related to complications they have experienced from the treatments they have endured. And I think we would 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 is the first time they have gone through it and hopefully the last time So part of what we have done here at ProFound is we have launched a global patient advocacy group called Let's Huddle, and that is led by Leonard Wheeler, who is a prostate cancer survivor and a Tulsa Pro patient. And that group is not meant to promote TULSA PRO. it is meant to promote awareness around men's health, in particular, prostate health and mental health. So 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. And what I can tell you from having the privilege to participate in that on 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. So personally, I am most excited about raising the awareness around men's health both prostate health and mental health, because they go hand in hand. And what really took place at SRS, in my opinion, is that the conversation that is 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, And we are forcing the dialogue the same way that women force the dialogue around breast cancer diagnosis, treatment, reconstruction. Women were subjected to total mastectomies, radical mastectomies where they had their breasts removed. They had their neck removed, and all they were left with was, you know, a flat chest wall. Well, 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. And 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 is ProFound or the other folks that offer interventions for men's prostate disease, that men should be aware, they should have access they should be empowered to make the decision with their clinician based on their clinical presentation and what is important to them as it relates to quality of life. Sexual function, urinary incontinence, genial length, mental health. So I apologize for the emboldened response. But I truly believe we are an inflection point here in men's health care. And we have got to get louder. So thank you for asking the question. Analyst: Yeah. Got it. No. Agree. And Very helpful. Thank you for that. And then maybe just 1 more question, if I may. We saw in the RP arm in the CAPTAIN trial that about 33 percent of patients had positive surgical margins. Any more Specific Timing Estimate For Later This Year Around When We will See the TULSA procedure histology and imaging for the, I think, 12-month biopsy and MRI results. to kind of quantify surgical margins. Arun Swarup Menawat: We are still in the process of collecting all the final data, We are in the-- you know, we have a vast majority of the patient data in. But we are not all the way there yet. We are still very comfortable that sometime in Q4, we should be able to get you know, the whole information out. 12 month data. I would still like to point out that in the TULSA arm, you know, it is biopsy, which is the gold standard of how we are measuring. And it is very detailed, and it is, versus in the robotic arm, it is basically measuring positive margins. Which is very, you know, much simpler and far less comprehensive. And most of the patients who underwent the robotic arm underwent what they call nerve-sparing prostatectomy. And so, you know, again, coming to that point about the trifecta, you know, we are seeing 35 percent positive margins. And you are seeing a little bit better than what you see in other studies on the erectile dysfunction. And so you know, we do think that we are in, you know, a pretty good position with respect to the particularly the trifecta, but to give you the answer, I think, most certainly, you are on track with Getting the information out in Q4. Got it. Okay. Great. Very helpful, and thank you for taking my questions. Thank you, Kyle. Thank you. Operator: This concludes the question and answer session. I would now like to turn it back to Doctor Menawat for closing remarks. Arun Swarup Menawat: Thank you so much, and thank you for all the analysts for their questions. Hopefully, we have 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. Before you buy stock in Profound Medical, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Profound Medical wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* Now, it’s worth noting Stock Advisor’s total average return is 964% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Profound Medical (PROF) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-08-07

Profound Medical Corp. Q2 2026 Earnings Call Summary

Moby
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributed the Q2 revenue shortfall to a $3.1 million consolidated shipment delay in late June, which was completed in July and will be recognized in Q3. The company is transitioning TULSA from early-adopter status to the mainstream market by positioning it as a versatile 'third category' capable of both whole-gland and focal ablation. Operational scaling is underway with the hiring of a VP-level operations lead and increased logistics staff to prevent future revenue recognition timing issues. Strategic focus has shifted toward 'Index 20' utilization metrics and dollar-based pipeline tracking to prioritize program quality and top-line growth over simple unit installations. Management highlighted TULSA's unique position as the only MRI-guided, autonomous robotic system, contrasting it with 'master-slave' robotic systems that rely on manual control. The clinical narrative is expanding beyond cancer control and 'trifecta' outcomes (erectile function and urinary continence) to also emphasize the preservation of penile length. Reiterated full-year 2026 revenue guidance of approximately $25 million, assuming the conversion of record order activity and a growing $70 million qualified sales pipeline. Anticipates FDA clearance for TULSA integration with the Siemens Free.Max interventional MR by early 2027, which is expected to lower adoption barriers for hospitals. Expects a significant expansion of the reimbursement premium in 2027, with proposed CMS rules increasing TULSA payments to $15.5 thousand, roughly 44% higher than competing modalities. Management projects full-year gross margins will remain at or above 70%, supported by high-margin consumables and capital equipment pricing leverage. The company plans to release comprehensive 12-month biopsy and histology data from the CAPTAIN trial in Q4 2026 to further support payer coverage and clinical adoption. Operating expenses decreased 16% year-over-year to $13 million, reflecting management's focus on 'leverageable' growth and a path toward profitability. A temporary 12% sequential decline in the utilization index was attributed to five specific sites facing short-term issues, including one transitioning from a placement to a capital model. Payer covera…Read full document

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributed the Q2 revenue shortfall to a $3.1 million consolidated shipment delay in late June, which was completed in July and will be recognized in Q3. The company is transitioning TULSA from early-adopter status to the mainstream market by positioning it as a versatile 'third category' capable of both whole-gland and focal ablation. Operational scaling is underway with the hiring of a VP-level operations lead and increased logistics staff to prevent future revenue recognition timing issues. Strategic focus has shifted toward 'Index 20' utilization metrics and dollar-based pipeline tracking to prioritize program quality and top-line growth over simple unit installations. Management highlighted TULSA's unique position as the only MRI-guided, autonomous robotic system, contrasting it with 'master-slave' robotic systems that rely on manual control. The clinical narrative is expanding beyond cancer control and 'trifecta' outcomes (erectile function and urinary continence) to also emphasize the preservation of penile length. Reiterated full-year 2026 revenue guidance of approximately $25 million, assuming the conversion of record order activity and a growing $70 million qualified sales pipeline. Anticipates FDA clearance for TULSA integration with the Siemens Free.Max interventional MR by early 2027, which is expected to lower adoption barriers for hospitals. Expects a significant expansion of the reimbursement premium in 2027, with proposed CMS rules increasing TULSA payments to $15.5 thousand, roughly 44% higher than competing modalities. Management projects full-year gross margins will remain at or above 70%, supported by high-margin consumables and capital equipment pricing leverage. The company plans to release comprehensive 12-month biopsy and histology data from the CAPTAIN trial in Q4 2026 to further support payer coverage and clinical adoption. Operating expenses decreased 16% year-over-year to $13 million, reflecting management's focus on 'leverageable' growth and a path toward profitability. A temporary 12% sequential decline in the utilization index was attributed to five specific sites facing short-term issues, including one transitioning from a placement to a capital model. Payer coverage expanded by 18.3 million lives in Q2, primarily through Medicaid, bringing the total non-Medicare covered lives to approximately 30 million. The proposed 2027 ASC reimbursement rate for TULSA shows a reduction to $6.87 thousand, though management noted they currently have no active ASC sites and intend to challenge the cost reporting data. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The $3.1 million delay was a consolidated shipment from Canada where delivery receipts were not received within the quarter timeframe. Management is addressing this by hiring a VP of Operations and increasing logistics staff to ensure smoother revenue recognition in future periods. The $70 million pipeline is split approximately 70% U.S. and 30% international, with TULSA PRO representing 90% of the value. Management moved to dollar-based reporting because unit counts become less meaningful once the install base exceeds 100 sites. While the median change is measured in millimeters, management emphasized that any shortening contributes to patient distress and reduced satisfaction. This data is being packaged with erectile and urinary outcomes to present a superior 'patient experience' narrative compared to robotic surgery. Utilization dips at certain sites occurred because programs were paused during the transition from temporary placement agreements to permanent capital acquisitions. Management views these pauses as a 'high-class problem' because capital ownership lowers the hospital's per-procedure cost and secures long-term commitment.

Investor releaseQuarter not tagged2026-08-07

Profound Medical Q2 Earnings Call Highlights

MarketBeat
Interested in Profound Medical? Here are five stocks we like better. Q2 revenue rose 12% to CAD 2.5 million, but about CAD 3.1 million in TULSA shipments moved from June into July; excluding the timing issue, revenue would have been approximately CAD 5.6 million, up 153% year over year. Profound maintained its 2026 revenue target of about CAD 25 million and gross-margin guidance of at least 70%. The TULSA-PRO qualified sales pipeline reached approximately CAD 70 million, with 84 systems installed and July setting a monthly record for new orders. Same-store utilization declined sequentially in Q2 because of temporary site issues but remained up year over year and increased 39% in the first half. Profound reported expanding reimbursement coverage and positive clinical data, while CMS proposed a 14.9% increase in TULSA’s 2027 payment rate to $15,494 per procedure. The company also expects potential FDA clearance for Siemens MRI integration by early 2027 and plans to release additional CAPTAIN trial results in Q4. Profound Medical (NASDAQ:PROF) reported second-quarter 2026 revenue of CAD 2.5 million, up 12% from CAD 2.2 million a year earlier, as the company said the reported figure was affected by the timing of TULSA product shipments completed in July rather than June. Corporate Controller Matthew Sobczyk said approximately CAD 3.1 million of shipments anticipated during the final weeks of June were completed in July, affecting revenue recognition for the quarter. Excluding the timing effect, second-quarter revenue would have totaled approximately CAD 5.6 million, representing 153% year-over-year growth, according to the company. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Profound recorded CAD 1.6 million in recurring revenue and CAD 871,000 in capital-equipment sales during the quarter. Gross margin increased to 78% from 73% in the year-earlier period. The company reported a net loss of CAD 9.5 million, or CAD 0.26 per share, compared with a net loss of about CAD 15.7 million, or CAD 0.52 per share, in the second quarter of 2025. Cash totaled CAD 38.3 million as of June 30. Chief Executive Officer and Chairman Arun Menawat said the company continues to expect approximately CAD 25 million in total revenue for full-year 2026, which would represent 56% growth from 2025. Profound also reiterated its expectation for full-year gross margin o…Read full document

Interested in Profound Medical? Here are five stocks we like better. Q2 revenue rose 12% to CAD 2.5 million, but about CAD 3.1 million in TULSA shipments moved from June into July; excluding the timing issue, revenue would have been approximately CAD 5.6 million, up 153% year over year. Profound maintained its 2026 revenue target of about CAD 25 million and gross-margin guidance of at least 70%. The TULSA-PRO qualified sales pipeline reached approximately CAD 70 million, with 84 systems installed and July setting a monthly record for new orders. Same-store utilization declined sequentially in Q2 because of temporary site issues but remained up year over year and increased 39% in the first half. Profound reported expanding reimbursement coverage and positive clinical data, while CMS proposed a 14.9% increase in TULSA’s 2027 payment rate to $15,494 per procedure. The company also expects potential FDA clearance for Siemens MRI integration by early 2027 and plans to release additional CAPTAIN trial results in Q4. Profound Medical (NASDAQ:PROF) reported second-quarter 2026 revenue of CAD 2.5 million, up 12% from CAD 2.2 million a year earlier, as the company said the reported figure was affected by the timing of TULSA product shipments completed in July rather than June. Corporate Controller Matthew Sobczyk said approximately CAD 3.1 million of shipments anticipated during the final weeks of June were completed in July, affecting revenue recognition for the quarter. Excluding the timing effect, second-quarter revenue would have totaled approximately CAD 5.6 million, representing 153% year-over-year growth, according to the company. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Profound recorded CAD 1.6 million in recurring revenue and CAD 871,000 in capital-equipment sales during the quarter. Gross margin increased to 78% from 73% in the year-earlier period. The company reported a net loss of CAD 9.5 million, or CAD 0.26 per share, compared with a net loss of about CAD 15.7 million, or CAD 0.52 per share, in the second quarter of 2025. Cash totaled CAD 38.3 million as of June 30. Chief Executive Officer and Chairman Arun Menawat said the company continues to expect approximately CAD 25 million in total revenue for full-year 2026, which would represent 56% growth from 2025. Profound also reiterated its expectation for full-year gross margin of at least 70%. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Menawat said the CAD 3.1 million shipment delay was a logistics and documentation issue involving a consolidated shipment from Canada, rather than an issue with demand. The company has increased logistics and operations staffing and is in the process of hiring an experienced vice president-level operations executive, he said. During the question-and-answer session, Menawat said the delayed revenue “most likely will be recognized in Q3.” He also distinguished the revenue-recognition matter from the time required for shipped systems to become operating treatment sites. Following shipment, hospitals must install the equipment, complete training, schedule patients and establish reimbursement processes. That process generally takes 60 to 120 days, he said. → Ulta's Growth Is Real, But So Are the Risks The company ended the second quarter with a TULSA-PRO install base of 84 systems. Menawat said Profound shipped six systems in the first quarter, four of which had been installed by the end of that period, while two remained in the installation process. He said the company shipped a similar number during the second quarter and expects the install base to increase again in the third quarter. Chief Commercial Officer Tom Tamberrino said Profound’s qualified sales pipeline for TULSA-PRO and Sonalleve was approximately CAD 70 million. The pipeline includes opportunities in the company’s verify, negotiate and contracting stages. Tamberrino said the figure was roughly split 70% in the U.S. and 30% internationally, while TULSA-PRO represented approximately 90% of the pipeline and Sonalleve accounted for about 10%. Profound moved away from reporting its pipeline primarily in units because management wants to focus on revenue, gross margin and the growth of treatment programs rather than system installations alone, Tamberrino said. He added that July set a monthly record for new orders, excluding the orders shifted from the second quarter. The company’s Index 20 measure of same-store sequential quarterly growth declined 12% in the second quarter, which management attributed mainly to temporary issues at five sites. One site paused treatments while transitioning from a placement model to a capital-purchase model, but has since resumed operations. Tamberrino said the Index 20 rose 39% in the first half of 2026 compared with the same period of 2025 and increased 22% year over year in the second quarter. At the Society of Robotic Surgery meeting, the company generated more than 160 qualified leads over four days, Tamberrino said. He cautioned that the timing and extent to which those leads become revenue cannot be predicted, though some have already progressed into negotiation and contracting stages. Tamberrino said CMS’ proposed 2027 hospital outpatient rule would keep TULSA at Urology APC Level 7 and raise the proposed payment 14.9% to $15,494 per procedure. Under the proposal, he said, the payment would exceed proposed amounts for HIFU and Aquablation of $10,797 and robotic radical prostatectomy of $12,300. The proposal remains subject to a final rule. Coverage for TULSA expanded by approximately 18.3 million covered lives in the second quarter, mostly through state Medicaid, managed Medicaid and veterans programs, according to the company. This followed 8.5 million covered lives added in the first quarter, including 6.9 million associated with Humana. Menawat said the company was close to 30 million covered lives excluding Medicare. Profound also announced that Johns Hopkins and Prime Healthcare employee health plans, covering more than 105,000 employees, medical staff and family members, had listed TULSA as a covered service. President Mathieu Burtnyk highlighted additional data from the CAPTAIN trial comparing whole-gland TULSA with robotic radical prostatectomy. He said TULSA showed statistically superior preservation of a composite endpoint involving urinary continence and erectile function at six months, as well as favorable perioperative outcomes including no blood loss, no overnight stay, less pain and faster recovery. At the Society of Robotic Surgery meeting, Profound presented data showing no median change in penile length one month after TULSA, compared with a median 0.65-centimeter reduction following robotic prostatectomy. Burtnyk said the company is preparing the findings alongside broader perioperative outcome data. He also said Profound expects to release 12-month biopsy and MRI information from the TULSA arm of CAPTAIN in the fourth quarter. Menawat said Profound expects, if development proceeds as planned, to receive FDA clearance for integration of TULSA with Siemens’ MAGNETOM Free.Max MRI system by early 2027. He said the company believes the integration could contribute meaningfully to growth in 2027. The company is also exploring the integration of PSMA PET imaging into TULSA-PRO treatment-planning software through a collaboration announced by Telix Pharmaceuticals in May. Menawat said the effort is intended to help physicians define the extent of prostate ablation, from whole-gland to focal treatments. Profound Medical Corp is a medical technology company headquartered in Toronto, Canada, that specializes in the development and commercialization of minimally invasive therapeutic solutions using magnetic resonance–guided ultrasound ablation. The company's proprietary platform delivers focused ultrasound energy to targeted tissue under real-time MR imaging, offering a non-incisional alternative to traditional surgical approaches. The company's lead product, the TULSA-PRO system, is designed for the treatment of prostate conditions, including localized prostate cancer and benign prostatic hyperplasia. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Profound Medical Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-07

Profound Medical Corp (PROF) (Q2 2026) Earnings Call Highlights: Record Orders and ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Profound Medical Corp (NASDAQ:PROF) reported strong underlying Q2 2026 performance, with revenue growing 153% year-over-year to approximately $5.6 million when excluding a $3.1 million shipment timing issue, and the company reiterated its full-year 2026 revenue guidance of approximately $25 million, representing 56% growth. The company's gross margin improved to 78% in Q2 2026, up from 73% in the prior year period, and management remains confident in sustaining gross margins above its stated 70% target over the long term. Profound Medical Corp (NASDAQ:PROF) is seeing accelerating commercial momentum, evidenced by a record month for new orders in July, a qualified sales pipeline of approximately $70 million, and over 160 qualified leads generated at the SRS 2026 conference. Reimbursement tailwinds are strengthening, with the CMS proposed 2027 OPPS rule showing a 14.9% increase in Tulsa's payment to $15,494 per procedure, which is 44% higher than Haifu and 26% higher than robotic prostatectomy, expanding the economic premium for hospitals. Clinical evidence continues to build, with CAPTAIN trial data demonstrating statistically superior quality of life outcomes, including better preservation of urinary continence, erectile function, and penile length compared to robotic radical prostatectomy, which is expected to support broader payer coverage decisions. Payer coverage is expanding rapidly, with approximately 18.3 million covered lives added in Q2 2026, including the first-ever employer-owned health plans (Johns Hopkins and Theme Healthcare) listing the Tulsa procedure as a covered service, bringing total covered lives to nearly 30 million (excluding Medicare). Profound Medical Corp (NASDAQ:PROF) experienced a $3.1 million revenue recognition timing issue in Q2 2026, as Tulsa product shipments originally anticipated in June were completed in July, causing reported revenue to only increase 12% year-over-year to $2.5 million, which does not fully reflect the company's sales performance. The company's same-store sequential quarterly growth, as measured by its new index 20, declined by 12% in Q2 2026, primarily due to five sites not realizing expected growth because of short-term issues, includ…Read full document

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Profound Medical Corp (NASDAQ:PROF) reported strong underlying Q2 2026 performance, with revenue growing 153% year-over-year to approximately $5.6 million when excluding a $3.1 million shipment timing issue, and the company reiterated its full-year 2026 revenue guidance of approximately $25 million, representing 56% growth. The company's gross margin improved to 78% in Q2 2026, up from 73% in the prior year period, and management remains confident in sustaining gross margins above its stated 70% target over the long term. Profound Medical Corp (NASDAQ:PROF) is seeing accelerating commercial momentum, evidenced by a record month for new orders in July, a qualified sales pipeline of approximately $70 million, and over 160 qualified leads generated at the SRS 2026 conference. Reimbursement tailwinds are strengthening, with the CMS proposed 2027 OPPS rule showing a 14.9% increase in Tulsa's payment to $15,494 per procedure, which is 44% higher than Haifu and 26% higher than robotic prostatectomy, expanding the economic premium for hospitals. Clinical evidence continues to build, with CAPTAIN trial data demonstrating statistically superior quality of life outcomes, including better preservation of urinary continence, erectile function, and penile length compared to robotic radical prostatectomy, which is expected to support broader payer coverage decisions. Payer coverage is expanding rapidly, with approximately 18.3 million covered lives added in Q2 2026, including the first-ever employer-owned health plans (Johns Hopkins and Theme Healthcare) listing the Tulsa procedure as a covered service, bringing total covered lives to nearly 30 million (excluding Medicare). Profound Medical Corp (NASDAQ:PROF) experienced a $3.1 million revenue recognition timing issue in Q2 2026, as Tulsa product shipments originally anticipated in June were completed in July, causing reported revenue to only increase 12% year-over-year to $2.5 million, which does not fully reflect the company's sales performance. The company's same-store sequential quarterly growth, as measured by its new index 20, declined by 12% in Q2 2026, primarily due to five sites not realizing expected growth because of short-term issues, including one site that paused treatments during a transition from a placement to a capital model. The proposed CMS 2027 rule for Ambulatory Surgical Centers (ASCs) would reduce Tulsa's payment to $6,866, a decrease that the company attributes to hospital cost reporting issues, and it currently has no active ASC sites, limiting near-term growth in this channel. The company continues to incur significant net losses, reporting a net loss of $9.5 million in Q2 2026, although this is an improvement from the $15.7 million loss in the prior year period, and the path to profitability remains dependent on continued revenue growth and expense management. There is a notable gap between product shipments and installations, with the installed base only increasing by 4 systems in Q2 2026 to 84, as sites typically take 60 to 120 days to become fully operational after receiving a system, which can delay revenue recognition and utilization growth. The company faces ongoing competitive and operational hurdles, including the need to correct hospital cost reporting that drove the proposed ASC payment reduction, and management acknowledges that the timing of converting its $70 million pipeline into recognized revenue is uncertain and can vary significantly. Warning! GuruFocus has detected 2 Warning Sign with PROF. Is PROF fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more color on the $3.1 million in Tulsa product shipments that slipped from Q2 to Q3, and what is being done to prevent this from happening again?A: Arun Mawat, CEO and Chairman, explained that the delay was due to a consolidated shipment from Canada where not all delivery receipts were obtained within the quarter, pushing revenue recognition to Q3. To address this, the company has increased its logistics and operating staff and is in the final stages of hiring a Vice President-level operations person to manage these processes more effectively. Q: Regarding the record $7 million in new orders for July, can you share what the previous record was and how quickly the 160 qualified leads from SRS 2026 might convert into actual orders?A: Tom Tamburio, Chief Commercial Officer, noted that it is difficult to give a definitive timeline, but anecdotally, some leads from SRS have already materialized into deals that are well down the funnel in the negotiating and contracting stages. He emphasized that medical device sales timelines vary greatly, ranging from a day to a year to complete. Q: Can you elaborate on the new penile length preservation data from the CAPTAIN trial and its significance?A: Matthew Burtnick, President, stated that the data shows no median change in penile length after Tulsa, compared to a 0.65 cm reduction after robotic prostatectomy. He emphasized that even modest penile shortening can contribute to patient distress and reduced satisfaction, and this result, combined with other quality-of-life benefits, paints a compelling picture of the Tulsa procedure's ability to preserve quality of life while treating cancer effectively. Q: Can you explain the difference between the Q2 shipment timing issue and the gap between units shipped and the installed base, and what is the typical timeline for a shipped system to become operational?A: Arun Mawat clarified that the Q2 issue was purely a logistics and shipping matter, while the installed base gap is related to the time it takes for sites to train staff, schedule patients, and establish their treatment programs. He noted that the typical gap is 60 to 120 days, but the company is working to reduce this closer to 60 days as momentum and urgency among sites increase. Q: Can you provide more detail on the $70 million qualified sales pipeline, including the split between Tulsa Pro and Sonaleve, and the geographic breakdown?A: Tom Tamburio stated that the pipeline is roughly a 70% US and 30% international split, and approximately 90% Tulsa Pro and 10% Sonaleve. He explained that the company moved away from providing unit counts to focus on maximizing top-line revenue and gross margin, with the goal of reaching 200 Tulsa Pro systems installed and treating an average of 50 patients per year. Q: Can you provide more color on the 12% sequential decline in the Index 20 same-store growth and the trends you are seeing in Q3?A: Tom Tamburio explained that the decline was mainly attributable to 5 sites not realizing expected growth due to short-term issues, such as one site converting from a placement to a capital model, which paused treatments during the transition. He noted that despite this, the first half of 2026 grew 39% year-over-year, and the momentum has continued into Q3 with record order activity. Q: Can you provide an update on the timing for the 12-month biopsy and MRI results from the CAPTAIN trial, particularly regarding surgical margins?A: Arun Mawat stated that the company is still collecting final data but expects to release the information in Q4. He highlighted that the Tulsa biopsy is the gold standard and is more detailed and comprehensive compared to the robotic arm's measurement of positive margins, noting that 33% of patients in the robotic arm had positive surgical margins despite nerve-sparing procedures. Q: How are patients involved in defining their treatment path, and what is being done to raise awareness about prostate health and treatment options?A: Tom Tamburio discussed the launch of a global patient advocacy group called "Let's Huddle," led by a prostate cancer survivor and Tulsa Pro patient. The group promotes awareness around men's health, prostate health, and mental health, providing a space for peer-to-peer conversation. He emphasized that the conversation around prostate disease treatment is shifting, and patients are becoming more empowered to make decisions based on quality of life factors. Q: Can you provide an update on the total number of covered lives for the Tulsa procedure, and are you assuming additional payer coverage in your 2026 guidance?A: Arun Mawat confirmed that the company is working with insurance companies on a routine basis and expects the number of covered lives to continue increasing. Matthew Slab, Corporate Controller, noted that the total covered lives are close to 30 million, excluding Medicare, which is on top of that number. Q: How do you see operating expenses scaling in the next few quarters as you bring on new operations people and expand the team?A: Arun Mawat stated that the company is focused on profitable growth and not growth at any cost. While there may be some quarterly fluctuations as resources are added, he expects that on a half-yearly perspective, costs will trend closely with revenue growth, highlighting the leverageability of the product with high margins and high dollar amounts per patient. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-07

Profound Medical (PROF) Q2 Earnings Surpass Estimates

Zacks
Profound Medical (PROF) came out with quarterly earnings of $0.26 per share, beating the Zacks Consensus Estimate of a loss of $0.22 per share. This compares to a loss of $0.52 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +218.18%. A quarter ago, it was expected that this company would post a loss of $0.24 per share when it actually produced a loss of $0.19, delivering a surprise of +20.83%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Profound Medical, which belongs to the Zacks Medical - Drugs industry, posted revenues of $2.48 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 55.66%. This compares to year-ago revenues of $2.21 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Profound Medical shares have added about 1.5% since the beginning of the year versus the S&P 500's gain of 12.8%. While Profound Medical has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Profound Medical was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks…Read full document

Profound Medical (PROF) came out with quarterly earnings of $0.26 per share, beating the Zacks Consensus Estimate of a loss of $0.22 per share. This compares to a loss of $0.52 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +218.18%. A quarter ago, it was expected that this company would post a loss of $0.24 per share when it actually produced a loss of $0.19, delivering a surprise of +20.83%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Profound Medical, which belongs to the Zacks Medical - Drugs industry, posted revenues of $2.48 million for the quarter ended June 2026, missing the Zacks Consensus Estimate by 55.66%. This compares to year-ago revenues of $2.21 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Profound Medical shares have added about 1.5% since the beginning of the year versus the S&P 500's gain of 12.8%. While Profound Medical has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Profound Medical was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.23 on $7.15 million in revenues for the coming quarter and -$0.88 on $25.1 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Perspective Therapeutics (CATX), is yet to report results for the quarter ended June 2026. This isotope-based medical products maker is expected to post quarterly loss of $0.27 per share in its upcoming report, which represents a year-over-year change of +10%. The consensus EPS estimate for the quarter has been revised 1% higher over the last 30 days to the current level. Perspective Therapeutics' revenues are expected to be $0.2 million, down 31% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Profound Medical (PROF) : Free Stock Analysis Report Perspective Therapeutics, Inc. (CATX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-06

Profound Medical Reports Second Quarter 2026 Financial Results

GlobeNewswire
– Operating expenses decline 16%, helping drive a 39% improvement in net loss – – Approximately $3.1 million of TULSA revenue recognition shifts into early Q3 due to shipment timing – – Strong clinical, commercial and reimbursement momentum continues – – Company reiterates full-year 2026 revenue guidance – – Announces first employer owned health plans to list the TULSA Procedure™ as a covered service – TORONTO, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (“iMRI”) procedures, today announced financial results for the second quarter ended June 30, 2026. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with U.S. generally accepted accounting principles (U.S. GAAP). “Commercial momentum continued to accelerate during the second quarter," said Arun Menawat, Profound's CEO and Chairman. “We received over $7.0 million in new purchase orders, a new quarterly record. Approximately $2.5 million of those orders were recognized as revenue during the quarter, while approximately $3.1 million was shipped in July and will be recognized in the third quarter. The shipment timing reflected a temporary logistics issue—not customer demand—and, absent the timing difference, second quarter revenue would have increased approximately 153% year-over-year. The logistics issue has since been resolved. Beyond top-line growth, our business model continued to demonstrate meaningful operating leverage. Gross margin remained above our long-term target of 70%, operating expenses declined 16%, and net loss improved by 39% year-over-year. Momentum has continued into the third quarter, including another monthly record for new order activity in July and exceptional physician engagement at SRS2026 that generated more than 160 qualified commercial opportunities over just four days. Based on continued payer coverage expansion, growing clinical validation, and a strengthening sales pipeline, we believe we are now in the strongest commercial position in the Company's history. Based on this momentum and our improved visibility into the second half of the year, we are reiterating the $25.0 million bar we previously set for 2026 total revenue." Business Highlights Cl…Read full document

– Operating expenses decline 16%, helping drive a 39% improvement in net loss – – Approximately $3.1 million of TULSA revenue recognition shifts into early Q3 due to shipment timing – – Strong clinical, commercial and reimbursement momentum continues – – Company reiterates full-year 2026 revenue guidance – – Announces first employer owned health plans to list the TULSA Procedure™ as a covered service – TORONTO, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (“iMRI”) procedures, today announced financial results for the second quarter ended June 30, 2026. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with U.S. generally accepted accounting principles (U.S. GAAP). “Commercial momentum continued to accelerate during the second quarter," said Arun Menawat, Profound's CEO and Chairman. “We received over $7.0 million in new purchase orders, a new quarterly record. Approximately $2.5 million of those orders were recognized as revenue during the quarter, while approximately $3.1 million was shipped in July and will be recognized in the third quarter. The shipment timing reflected a temporary logistics issue—not customer demand—and, absent the timing difference, second quarter revenue would have increased approximately 153% year-over-year. The logistics issue has since been resolved. Beyond top-line growth, our business model continued to demonstrate meaningful operating leverage. Gross margin remained above our long-term target of 70%, operating expenses declined 16%, and net loss improved by 39% year-over-year. Momentum has continued into the third quarter, including another monthly record for new order activity in July and exceptional physician engagement at SRS2026 that generated more than 160 qualified commercial opportunities over just four days. Based on continued payer coverage expansion, growing clinical validation, and a strengthening sales pipeline, we believe we are now in the strongest commercial position in the Company's history. Based on this momentum and our improved visibility into the second half of the year, we are reiterating the $25.0 million bar we previously set for 2026 total revenue." Business Highlights Clinical Momentum The post-market CAPTAIN Level 1 randomized clinical data continued to demonstrate statistically significant advantages of the TULSA Procedure™ over robotic radical prostatectomy, with new penile length preservation data presented in July 2026. Physician awareness of, and engagement with, the TULSA Procedure continued to expand through presentations at the 2026 meetings of the Society of Interventional Radiology (SIR), the American Urological Association (AUA), and the Society of Robotic Surgery (SRS). Reimbursement Expansion Payer coverage expanded by approximately 18.3 million covered lives during the second quarter, substantially broadening patient access to the TULSA Procedure. Most of the newly covered lives came through state Medicaid and managed Medicaid (Ambetter) programs. Today, Profound is pleased to announce that the Johns Hopkins Employee Health Plan and the Prime Healthcare Employee Health Plan, covering more than 50,000 and 55,000 employees, medical staff and family members, respectively, have become the first employer owned health plans to list the TULSA Procedure as a covered service. Commercial Execution & Adoption Profound’s TULSA-PRO® installed base increased to 84 at the end of Q2-2026. Profound estimates that the current aggregate total dollar value of its qualified sales pipeline (defined as within one of the “Verify, Negotiate and Contracting” stages) for TULSA-PRO and Sonalleve® is approximately $70.0 million.* Continuing Innovation Profound also launched an initiative to explore the potential of integrating PSMA PET molecular imaging technologies with the TULSA Procedure to support intention-to-treat decisions and patient monitoring. * There can be no assurance given with respect to the extent and/or timing of the Company’s qualified sales pipeline resulting in recognized revenue. Q2-2026 Clinical Utilization Trends Physicians continued to utilize the TULSA Procedure’s customizable prostate tissue ablation capabilities in the second quarter of 2026: Prostate Condition Regional Ablation Prostate Size TULSA INDEX20 Introduced by the Company in the first quarter of 2026, the following supplemental ‘same-store’ TULSA Procedure volume analysis is designed to track a fixed cohort (i.e. without any changes or substitutions) of 20 active commercial TULSA-PRO sites over time. The TULSA INDEX20 includes a representative variety of providers, including teaching hospitals and private-pay practices, all of which have been performing TULSA Procedures for at least 12 months. Geographically, 80% of the index sites are in the U.S. and 20% are international. Summary Second Quarter 2026 Results For the quarter ended June 30, 2026, Profound recorded total revenue of approximately $2.5 million, up 12% year-over-year, including $1.6 million of recurring non-capital revenue from single-use devices and services associated with extended warranties, and $871,000 from capital equipment sales. Approximately $3.1 million of TULSA product shipments originally anticipated in the final week of June were completed in July. The timing affected only the period of revenue recognition and did not reflect any change in customer demand or order activity. Excluding this shipment timing, second quarter revenue would have been approximately $5.6 million, representing 153% year-over-year growth. Gross margin expanded to 78% in Q2-2026 from 73% in the prior-year period, reflecting a favorable product mix, including multiple capital system sales that were previously under operating leases to customers. Operating expenses declined 16% year over year to approximately $13.0 million, primarily reflecting lower personnel, commercial, travel, insurance and CAPTAIN clinical trial costs following completion of enrollment. These reductions were partially offset by higher R&D investments focused on product cost reduction, quality improvements and manufacturing efficiencies. Second quarter 2026 net loss was approximately $9.5 million, or $0.26 per common share, a 39% improvement from a net loss of approximately $15.7 million, or $0.52 per common share, in the three months ended June 30, 2025. Liquidity and Outstanding Share Capital As at June 30, 2026, Profound had cash of approximately $38.3 million. As at August 6, 2026, Profound had 36,532,594 common shares issued and outstanding. For complete financial results, please see Profound’s filings, which will be made available under Profound’s profile at www.sedarplus.com, www.sec.gov and on Profound’s website under “SEC & SEDAR+ Filings.” Full Year 2026 Financial Outlook Based on record order activity, continued expansion of its commercial pipeline and improved visibility into second-half shipments, Profound continues to project total revenue for full-year 2026 to be approximately $25.0 million, which represents 56% growth compared to its prior year revenue. The Company also continues to expect full year 2026 gross margin to be 70% or higher. Conference Call Details Profound is pleased to invite all interested parties to participate in a conference call today at 4:30 pm ET during which time the results will be discussed. To participate in the conference call by telephone, please pre-register via this link to receive the dial-in number and your unique PIN. The call will also be broadcast live and archived on Profound's website in the Investors section here. About Profound Medical Corp. Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures.  The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction. Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery — and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies. Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the Europe, Canada, China, and Saudi Arabia. Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy — expanding access to precise, personalized, and incision-free treatment options worldwide. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technologies for disease conditions requiring MR-Guided ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO® and Sonalleve® system sales from its qualified sales pipeline; Profound’s expectations for future revenues/financial results; and the success of Profound’s commercialization strategy and activities for TULSA-PRO and Sonalleve. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound's Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.com and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and 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. Financial Outlook This press release contains a financial outlook within the meaning of applicable securities laws. The financial outlook has been prepared by management of the Company to provide an outlook for the Company’s forecasted revenue for the 12 months to be ended December 31, 2026, and may not be appropriate for any other purpose. The financial outlook has been prepared based on a number of assumptions, including the assumptions discussed under the heading “Forward-Looking Statements” herein. The actual results of the Company’s operations for any period may vary from the amounts set forth in these projections, and such variations may be material. The Company and its management believe that the financial outlook has been prepared on a reasonable basis. However, because this information is highly subjective and subject to numerous risks, including the risks discussed under the heading “Forward-Looking Statements” herein, it should not be relied on as necessarily indicative of future results. For further information, please contact: Stephen KilmerInvestor [email protected]  T: 647.872.4849

TranscriptFY2026 Q22026-08-06

FY2026 Q2 earnings call transcript

Earnings source - 106 paragraphs
Operator

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

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 U.S. 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

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 CAD 2.5 million, with CAD 1.6 million from recurring revenue and CAD 871,000 from capital equipment sales.

Matthew Sobczyk

Second quarter 2026 revenue was up 12% from CAD 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 CAD 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 CAD 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

Overall, the company recorded a second quarter 2026 net loss of CAD 9.5 million or CAD 0.26 per common share, compared to a net loss of approximately CAD 15.7 million or CAD 0.52 per common share in the three months ended June 30th, 2025. As of June 30th, 2026, Profound had cash of CAD 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 CAD 25 million, which represents 56% growth compared to its prior year revenue. With that, I'll now turn the call ove

Matthew Sobczyk

r to Mathieu Burtnyk for an update on clinical and development activities.

Mathieu Burtnyk

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

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 centimeter 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

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 make TULSA most versatile.

Mathieu Burtnyk

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

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

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 CAD 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

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 CAD 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

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

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

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

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

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

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

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 U.S. and more worldwide, that number continues to grow.

Arun Menawat

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

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

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

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 incision-less 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

We estimate that the current aggregate total dollar value of our qualified sales pipeline for TULSA-PRO and Sonalleve is approximately CAD 70 million. We are reiterating our approximate CAD 25 million total revenue outlook for full-year 2026, which represents 56% growth compared to 2025. We also continue to expect full-year growth 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

Good afternoon, gentlemen. Thanks for taking the questions. First off for me, just thinking about the CAD 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

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

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

To be on the CAD 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

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

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

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

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

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

Okay. Got it. Well, thanks.

Arun Menawat

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

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

Arun Menawat

Yeah.

Ben Haynor

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

Arun Menawat

Thank you, Ben.

Ben Haynor

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

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

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

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

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 CAD 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 CAD 70 million aggregate value.

Tom Tamberrino

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 CAD 70 million that fall within the verify, negotiate, and contract categories of the sales funnel, it's roughly a 70%/30% split between the U.S. and international in terms of CAD 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 CAD 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

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

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

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

Tom Tamberrino

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

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

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

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

Tom Tamberrino

Thank you, Michael.

Operator

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

Scott McAuley

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

Yeah

Scott McAuley

Some of those numbers.

Arun Menawat

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

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

Yeah

Scott McAuley

your work on.

Arun Menawat

That's-

Scott McAuley

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

Arun Menawat

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

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 Canadian 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 Canadian 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

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

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

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

Yeah

Scott McAuley

Income statement growing in the next few quarters?

Arun Menawat

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

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

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

Arun Menawat

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

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 CAD 18.3 million in this last quarter and up CAD 8.5 million in Q1. Just wondering if you have a total running number.

Arun Menawat

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

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

Arun Menawat

Yeah.

Mathieu Burtnyk

I think it was in the CAD 8.5 million.

Arun Menawat

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

Kyle Bauser

Okay. Including Medicare as well.

Arun Menawat

No, that does not include Medicare.

Kyle Bauser

Yeah.

Arun Menawat

Medicare is on top of that. Yeah.

Kyle Bauser

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

Arun Menawat

Yes.

Kyle Bauser

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

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

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

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

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

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

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

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

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

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

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

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

Arun Menawat

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

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.

Investor releaseQuarter not tagged2026-08-05

Earnings To Watch: Profound Medical Corp (PROF) Q2 2026 -- GF Value Sees 226% Upside

GuruFocus.com

This article first appeared on GuruFocus. Profound Medical Corp (NASDAQ:PROF) is set to release its Q2 2026 earnings on Aug 6, 2026. The consensus estimate for Q2 2026 revenue is 5.28 million, and the earnings are expected to come in at -0.24 per share. The full year 2026's revenue is expected to be $26.59 million and the earnings are expected to be $-0.9 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 1 Warning Sign with PROF. Is PROF fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for Profound Medical Corp (NASDAQ:PROF) have declined from $31.17 million to $26.59 million for the full year 2026 and declined from $49.84 million to $45.22 million for 2027 over the past 90 days. Earnings estimates for Profound Medical Corp (NASDAQ:PROF) have increased from $-0.96 per share to $-0.9 per share for the full year 2026 and declined from $-0.87 per share to $-0.92 per share for 2027 over the past 90 days. In the previous quarter of 2026-03-31, Profound Medical Corp's (NASDAQ:PROF) actual revenue was $5.34 million, which beat analysts' revenue expectations of $4.85 million by 10.04%. Profound Medical Corp's (NASDAQ:PROF) actual earnings were $-0.19 per share, which beat analysts' earnings expectations of $-0.27 per share by 29.63%. After releasing the results, Profound Medical Corp (NASDAQ:PROF) was down by -4.33% in one day. Based on the one-year price targets offered by 4 analysts, the average target price for Profound Medical Corp (NASDAQ:PROF) is $11.05 with a high estimate of $12 and a low estimate of $10. The average target implies an upside of 32.18% from the current price of $8.36. Based on GuruFocus estimates, the estimated GF Value for Profound Medical Corp (NASDAQ:PROF) in one year is $27.25, suggesting an upside of 225.96% from the current price of $8.36. Based on the consensus recommendation from 5 brokerage firms, Profound Medical Corp's (NASDAQ:PROF) average brokerage recommendation is currently 1.4, indicating a "Buy" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-07-24

Profound Medical Reports New Statistically Significant Tulsa Trial Results; Shares Rise

MT Newswires

Profound Medical (PROF) said new data from a Level 1 evidence trial of its MRI-guided Tulsa procedur

Investor releaseQuarter not tagged2026-07-16

Profound Medical to Release Second Quarter 2026 Financial Results on August 6th – Conference Call to Follow

GlobeNewswire
TORONTO, July 16, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (iMRI) procedures, will announce its second quarter 2026 financial results after market close on Thursday, August 6, 2026. Profound management will host a conference call at 4:30 p.m. ET to review the financial results and discuss business developments in the period. Second Quarter 2026 Results Conference Call Details: Date: Thursday, August 6, 2026 Time: 4:30 p.m. ET Live Call Registration: https://register-conf.media-server.com/register/BI1680e67d2b6f4f81b268df3183400d7c The call will also be broadcast live and archived on the Company's website in the Investors section here. About Profound Medical Corp. Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures. The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care — from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction. Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery — and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies. Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue.…Read full document

TORONTO, July 16, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (iMRI) procedures, will announce its second quarter 2026 financial results after market close on Thursday, August 6, 2026. Profound management will host a conference call at 4:30 p.m. ET to review the financial results and discuss business developments in the period. Second Quarter 2026 Results Conference Call Details: Date: Thursday, August 6, 2026 Time: 4:30 p.m. ET Live Call Registration: https://register-conf.media-server.com/register/BI1680e67d2b6f4f81b268df3183400d7c The call will also be broadcast live and archived on the Company's website in the Investors section here. About Profound Medical Corp. Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures. The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care — from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction. Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery — and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies. Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the Europe, Canada, China, and Saudi Arabia. Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy — expanding access to precise, personalized, and incision-free treatment options worldwide. For further information, please contact: Stephen KilmerInvestor [email protected] T: 647.872.4849

Investor releaseQuarter not tagged2026-05-14

Profound Medical Annual General and Special Meeting of Shareholders Voting Results

TMX Newsfile
Toronto, Ontario--(Newsfile Corp. - May 13, 2026) - Profound Medical Corp. (TSX: PRN) (NASDAQ: PROF) ("Profound" or the "Company") is pleased to announce the voting results from its Annual General and Special Meeting of Shareholders that was held today (the "Meeting"). A total of 25,347,133 common shares, representing 69.754% of the common shares outstanding, were represented in person and by proxy at the Meeting. All of the matters put forward before the shareholders, as set out in the Company's management information circular dated April 2, 2026 (the "Information Circular"), were approved by the requisite majority of votes cast at the Meeting. Election of Directors At the meeting, the shareholders of the Company elected all eight (8) nominees for the board of directors (the "Board"). Detailed results of the voting in respect of the election of directors are as follows: Other Matters The Company's shareholders also approved the appointment of PricewaterhouseCoopers LLP as the auditor for the Company to hold office until the close of the next annual meeting or until its successor is duly appointed, at such remuneration as may be determined by the board of directors and an ordinary resolution approving all unallocated restricted share units and deferred share units under the Company's long-term incentive plan, as more particularly described in the Information Circular. Detailed voting results for all resolutions will be posted under the Company's profile at www.sedarplus.ca. About Profound Medical Corp. Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue. Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia ("BPH"); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to…Read full document

Toronto, Ontario--(Newsfile Corp. - May 13, 2026) - Profound Medical Corp. (TSX: PRN) (NASDAQ: PROF) ("Profound" or the "Company") is pleased to announce the voting results from its Annual General and Special Meeting of Shareholders that was held today (the "Meeting"). A total of 25,347,133 common shares, representing 69.754% of the common shares outstanding, were represented in person and by proxy at the Meeting. All of the matters put forward before the shareholders, as set out in the Company's management information circular dated April 2, 2026 (the "Information Circular"), were approved by the requisite majority of votes cast at the Meeting. Election of Directors At the meeting, the shareholders of the Company elected all eight (8) nominees for the board of directors (the "Board"). Detailed results of the voting in respect of the election of directors are as follows: Other Matters The Company's shareholders also approved the appointment of PricewaterhouseCoopers LLP as the auditor for the Company to hold office until the close of the next annual meeting or until its successor is duly appointed, at such remuneration as may be determined by the board of directors and an ordinary resolution approving all unallocated restricted share units and deferred share units under the Company's long-term incentive plan, as more particularly described in the Information Circular. Detailed voting results for all resolutions will be posted under the Company's profile at www.sedarplus.ca. About Profound Medical Corp. Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue. Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia ("BPH"); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to preserve patients' urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free "one-and-done" procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration ("FDA"). Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, statements relating to the expectations regarding the efficacy of Profound's technologies for disease conditions requiring ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma and the success of Profound's commercialization strategy and activities for TULSA-PRO and Sonalleve. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound's Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.ca and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and 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. For further information, please contact: Stephen Kilmer Investor Relations [email protected] T: 647.872.4849 To view the source version of this press release, please visit https://www.newsfilecorp.com/release/297432

Investor releaseQuarter not tagged2026-05-09

Profound Medical Q1 Earnings Call Highlights

MarketBeat
Interested in Profound Medical? Here are five stocks we like better. Profound Medical’s Q1 revenue more than doubled to about CAD 5.3 million, with gross margin holding at 72% and the net loss narrowing to CAD 7 million. The company ended the quarter with CAD 50.3 million in cash and expects full-year 2026 gross margin of 70% or better. The company issued its first formal 2026 outlook, targeting about CAD 25 million in revenue and at least 70% gross margin, while maintaining its goal of roughly 120 TULSA installations by year-end. Management said the installed base reached 80 systems in Q1 and that the business remains on a growth path. Profound highlighted new clinical and reimbursement momentum for TULSA, including the CAPTAIN trial’s positive safety and recovery results versus prostatectomy and Humana beginning coverage. Management also said broader adoption could be helped by interventional MRI integration, with FDA clearance for that system expected by year-end. Profound Medical (NASDAQ:PROF) reported sharply higher first-quarter revenue and reiterated its view that adoption of its TULSA prostate treatment platform is moving toward broader commercial use, supported by new clinical data, payer progress and a growing installed base. For the three months ended March 31, 2026, Chief Financial Officer Rashed Dewan said the company recorded revenue of approximately CAD 5.3 million, up 104% from CAD 2.6 million in the same period a year earlier. Recurring revenue accounted for CAD 2.5 million, while CAD 2.9 million came from one-time sales of capital equipment. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Gross margin was 72%, compared with 71% in the prior-year quarter. Dewan said the increase was primarily due to product mix, as capital equipment sales carry higher margins. Operating expenses fell 9% to CAD 11.8 million from CAD 13 million a year earlier. Profound posted a net loss of CAD 7 million, or CAD 0.19 per share, compared with a net loss of CAD 10.7 million, or CAD 0.36 per share, in the first quarter of 2025. The company ended the quarter with CAD 50.3 million in cash. Dewan said Profound expects cash burn to decline as revenue grows and margins remain high, adding that the company continues to expect full-year 2026 gross margin of 70% or better. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Chief Executive Officer…Read full document

Interested in Profound Medical? Here are five stocks we like better. Profound Medical’s Q1 revenue more than doubled to about CAD 5.3 million, with gross margin holding at 72% and the net loss narrowing to CAD 7 million. The company ended the quarter with CAD 50.3 million in cash and expects full-year 2026 gross margin of 70% or better. The company issued its first formal 2026 outlook, targeting about CAD 25 million in revenue and at least 70% gross margin, while maintaining its goal of roughly 120 TULSA installations by year-end. Management said the installed base reached 80 systems in Q1 and that the business remains on a growth path. Profound highlighted new clinical and reimbursement momentum for TULSA, including the CAPTAIN trial’s positive safety and recovery results versus prostatectomy and Humana beginning coverage. Management also said broader adoption could be helped by interventional MRI integration, with FDA clearance for that system expected by year-end. Profound Medical (NASDAQ:PROF) reported sharply higher first-quarter revenue and reiterated its view that adoption of its TULSA prostate treatment platform is moving toward broader commercial use, supported by new clinical data, payer progress and a growing installed base. For the three months ended March 31, 2026, Chief Financial Officer Rashed Dewan said the company recorded revenue of approximately CAD 5.3 million, up 104% from CAD 2.6 million in the same period a year earlier. Recurring revenue accounted for CAD 2.5 million, while CAD 2.9 million came from one-time sales of capital equipment. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Gross margin was 72%, compared with 71% in the prior-year quarter. Dewan said the increase was primarily due to product mix, as capital equipment sales carry higher margins. Operating expenses fell 9% to CAD 11.8 million from CAD 13 million a year earlier. Profound posted a net loss of CAD 7 million, or CAD 0.19 per share, compared with a net loss of CAD 10.7 million, or CAD 0.36 per share, in the first quarter of 2025. The company ended the quarter with CAD 50.3 million in cash. Dewan said Profound expects cash burn to decline as revenue grows and margins remain high, adding that the company continues to expect full-year 2026 gross margin of 70% or better. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Chief Executive Officer Dr. Arun Menawat said Profound is projecting total 2026 revenue of approximately CAD 25 million, representing 56% growth compared with 2025, with gross margin of at least 70%. During the question-and-answer session, Menawat described the forecast as the company’s first “proper guidance” and said management remains bullish on the business. He said the figure should be viewed as a starting point that could be adjusted as the year progresses. → Years in the Making, AMD’s Upside Movement Has Just Begun Profound also said its TULSA-PRO installed base reached 80 systems at the end of the first quarter. The company sold eight systems during the quarter, two of which were installed. Six additional systems were shipped but had not yet been installed, and the company said revenue is recognized when systems are shipped. Management said there is no change to its previously discussed target of reaching approximately 120 installations by the end of 2026. The company also reiterated a longer-term profitability framework of 200 TULSA sites performing an average of at least 50 procedures per year. President Dr. Mathieu Burtnyk reviewed recent results from the CAPTAIN trial, a level 1 post-market study comparing the TULSA procedure with robotic radical prostatectomy in men with localized prostate cancer. He said the trial showed TULSA achieved its primary safety endpoint, with statistically higher preservation of a composite measure of urinary incontinence and erectile function at six months. Burtnyk also said TULSA patients experienced superior perioperative outcomes, including no blood loss, no overnight hospital stay, less pain, faster recovery, statistically significantly fewer serious complications and a faster return to normal activities and paid employment. He said TULSA is supported by more than 70 peer-reviewed publications and more than 200 scientific conference presentations, spanning whole gland treatment, partial gland treatment, large prostates, salvage settings, cancer and benign prostatic hyperplasia combinations, and BPH alone. “TULSA is not a niche solution,” Burtnyk said, describing it as a platform that can be applied across multiple prostate disease settings. Menawat said commercial data show that about 91% of TULSA patient prostates are treated as whole gland procedures or ablations of more than 50% of the prostate. The remaining 9% are focal therapy cases. He said the data support management’s view that TULSA gives urologists flexibility to personalize treatment rather than select only patients suited to a narrower modality. The company said it will begin publishing additional tables in quarterly releases to help investors track adoption. One table will detail the variety of patients treated with TULSA, while another, called the TULSA Index, will track same-store sales trends. Menawat said the initial TULSA Index includes 20 sites that have used TULSA for at least one year and represent a mix of large hospitals, smaller hospitals and private practices. He said the company plans to show rolling five-quarter trends and may expand the index over time. Chief Commercial Officer Tom Tamberrino said Profound’s commercial pipeline remains “north of triple digits” across verified, negotiation and contracting stages. He said pipeline accounts have attributes similar to those in the company’s initial 20-site index. On reimbursement, Tamberrino discussed the company’s recent announcement that Humana has begun covering TULSA. He said the decision was driven not by one specific study but by the overall body of clinical evidence, including the company’s 70-plus publications. Tamberrino said private insurer payment rates that Profound is seeing are generally about 1.5 to 2.5 times Medicare rates, depending on geographic adjustments. Menawat said management is pleased with that range and views Humana’s coverage as an important step because it is one of the top five payers. Tamberrino also said Profound’s patient access team has been successful in case-by-case appeals with private insurers, winning approximately 80% of cases in which it is involved. He said that compares with an industry standard he understands to be roughly 50% to 60%. Menawat also addressed the role of MRI systems in TULSA adoption. He said TULSA is compatible with an installed base of about 4,000 MRI systems in the United States, with more available globally, and that the number continues to grow. He said MRI systems designed specifically for interventional procedures are becoming commercially available and are smaller, lighter, easier to use and less costly to acquire and maintain than traditional MRI systems. Menawat pointed to the Siemens Free Series as an example and said Cook Medical is partnering with Siemens to provide a turnkey interventional MRI solution to hospitals. Profound expects, if all goes well, to receive FDA clearance by year-end for integration of TULSA with the new interventional MRI system. Menawat said the company believes that integration could meaningfully contribute to growth in 2027. Burtnyk said TULSA is already named in NCCN guidelines under clinical trial or registry use, and he said the company expects continued publication of CAPTAIN data and broader evidence to support further guideline recognition over time. Profound Medical Corp is a medical technology company headquartered in Toronto, Canada, that specializes in the development and commercialization of minimally invasive therapeutic solutions using magnetic resonance–guided ultrasound ablation. The company's proprietary platform delivers focused ultrasound energy to targeted tissue under real-time MR imaging, offering a non-incisional alternative to traditional surgical approaches. The company's lead product, the TULSA-PRO system, is designed for the treatment of prostate conditions, including localized prostate cancer and benign prostatic hyperplasia. The article "Profound Medical Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook