Profound Medical Corp.

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Good afternoon, ladies and gentlemen, and welcome to the Profound Medical Q1 2026 Financial Results Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, May 7th, 2026. I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Please go ahead.

Thank you. Good afternoon, everyone.

Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws in the United States and Canada. All forward-looking statements are based on Profound's current beliefs, assumptions, and expectations, and relate to, among other things, any express or implied statements or guidance regarding current or future financial performance and position, and expectations regarding the efficacy of Profound's technology. Such statements involve known and unknown risks, 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, Rashed Tawan, the company's Chief Financial Officer, Dr. Matthew Burtnick, Profound's president, and Tom Tamburino, our chief commercial officer. With that said, I'll now turn the call over to Rishabh.

Good afternoon, everyone, and welcome to our first 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 Matthew in a moment to provide clinical updates. However, before I do, I would like to provide a brief summary of our first 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 March 31, 2026, the company recorded revenue of $5.3 million, with $2.5 million from recurring revenue and $2.9 million from one-time sale of capital equipment. First quarter 2026 revenue was up 104% from $2.6 million for the same three-month period a year ago. Gross margin in Q1 2026 was 72% compared to 71% in Q1 2025. The increase in first quarter 2026 gross margin was primarily due to product makes, whereby more capital equipment was sold, which contains a higher margin. Total operating expenses in the 2026 first quarter were $11.8 million, down 9% from $13 million in the first quarter of 2025. Overall, the company recorded a first quarter 2026 net loss of $7 million or 19 cents per common share compared to a net loss of approximately 10.7 million or 36 cents per common share in the three months ended March 31, 2025. As of March 31, 2026, Profound had cash of $50.3 million. As Arun will discuss later in the call, we believe that we continue to be on a path to profitable growth. In keeping with that, we expect our cash flow to decline and eventually turn cash flow positive as our revenue continues to grow and our margin remains high. We continue to expect full year 2026 gross margin to be 70% or better as indicated before. With that, I will now turn the call over to Matthew for an update on clinical and development activities.

Thank you, Rashid, and good afternoon. Just a few weeks ago, we were joined by Dr. Lawrence Klotz on a conference call to discuss the first clinical outcomes from the Level 1 post-market captain trial, comparing the safety and efficacy of the Tulsa procedure with robotic radical prostatectomy in men with localized prostate cancer. Rather than going over all that information again, I invite you to see our press release dated March 13th and listen to the associated conference call replay, which is available in the IR calendar posted to our website. The CAPTEN trial demonstrated that Tulsa delivered statistically superior quality-of-life outcomes compared to radical prostatectomy, achieving its primary safety endpoint with statistically higher preservation of the composite endpoint of urinary continence and erectile function at six months. In addition, patients treated with Tulsa experience 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. These positive outcomes from CAPTEN sit on top of an already solid clinical foundation. Tulsa is supported by more than 70 peer-reviewed publications and over 200 scientific conference presentations. Importantly, this body of evidence wasn't built in a single way or for a single use case. Rather, we've supported both sponsored and investigator-initiated trials to demonstrate that Tulsa is not only effective, but flexible and customizable across whole-gland treatment, partial-gland treatment, large prostates, salvage settings, combinations of cancer and BPH, and patients with BPH alone. Our open, international care registry captures this spectrum as any patient treated with Tulsa, regardless of disease state, is eligible to be included. The takeaway is clear. Tulsa is not a niche solution. It's a platform that can be applied in many different ways while delivering consistent, predictable, and durable outcomes. CAPTEN completes the final foundational pillar of clinical evidence validating Tulsa as a new platform for prostate disease management. from gold standard treatment resect data to tax durable five-year outcomes, Captain now positions us to demonstrate with statistical rigor Tulsa's superior quality of life profile while delivering whole-gland treatment efficacy. As Arun will review next, Tulsa is solving the debate between focal and whole-gland treatment for prostate cancer. I will now turn the call over to Arun.

Thank you, Matthew, and good afternoon, everyone. While Tom is here to participate in the Q&A as usual to help streamline things, I will personally cover the business section today. As I discussed in our Q4 call, the dynamics in the prostate disease treatment space continues to change at a decent pace. Whole-gland robotic prostatectomy or radiation therapy are the standard of care for treating prostate cancer today. And for VPH, mainstream treatment with transurethral resection of the prostate or TURP has largely been unchanged over the past 100 years. It is our belief that today's standards have plateaued and that we can do better than the clinical outcomes of these standards. The initial captain data that Matthew just talked about is a clear example of the potential of our TELSA technology. As you know, many alternative technologies are competing to try to unseat today's standards, and while we believe it is great to see such innovation, it is also important to present to you how TELSA stands in its capabilities as compared to today's standards, as well as multiple focal therapies. I would like to share with you a few of the key unique aspects of the TELSA technology. We publish every quarter the types of patients that are being treated using the TULSA procedure. Starting this quarter, that information has been tabularized for easier review, comparison, and follow-up. The commercial data clearly shows that about 91% of TULSA patient prostates are treated either as whole-gland or more than 50% of prostate ablations. The remaining 9% are focal therapy cases. We have been publishing this information for the last several quarters, but it is more relevant today than ever before. The point is that TELSA is the most versatile and flexible technology that empowers the urologist to personalize the treatment to fit each patient's situation. This turns the previous paradigm, with urologists having to match the right subset of patients that are the most suitable candidates for a particular treatment modality on its head. We believe that this is a major advantage to drive adoption of TULSA. Another uniqueness of TELSA is what I described in the recent presentation at the Bloomberg Conference where I showed a picture of a leading urologist, Dr. Claus, treating a patient comfortably leaning in his chair with a half-eaten apple in one hand and the TELSA computer mouse in the other. That, frankly, is the future of surgery. Based upon the feedback we are getting, the TELSA procedure is the least stressful procedure of any that a urologist performs today. Another topic that has been discussed in more detail lately relates to the energy source that is deployed by the various alternatives. Since we capture the real-time tissue temperature using the MR, the Tulsa technology is tuned to heat the tissue only to 57 degrees centigrade, at which point the tissue dies instantly. This is therefore the minimal energy deployed for maximum impact. Any other technology in comparison is either heating the tissue to the point of boiling or charring, which has its own side effects, or cold cutting the tissue, in which case the tissue DNA is not dead. The science correlates the TELSAT technology to improve safety and clinical outcomes data of the TELSAT procedure based upon evaluation in over 70 publications on a variety of prostates. We believe strongly in the 10% theory that says that we will achieve an inflection point as we convert at least 10% of the patient population. We are growing at a faster pace than the growth rate of prostate cancer. And accordingly, we're clearly advancing towards the 10%. And although we're not there yet, we believe it is only a matter of time. As far as the comparison to alternatives, we believe that while each will find their own sweet spot in time, only Tulsa has the true potential of becoming a mainstream treatment modality. One of the pillars of our growth strategy is to continue to demonstrate the flexibility and capability of Tulsa. To demonstrate consistent progress of TELSA adoption, you will see two tables in our quarterly press releases. The one I just mentioned in the variety of patients where TELSA treatment applies, which is a good indicator of total TAM, and the second one, a new TELSA index table, which will be a good indicator of the growth of same store sales. We have picked 20 sites to make up the index that has been using Tulsa for at least a year and represent what we believe is the appropriate mix of different types of customers, including large hospitals, smaller hospitals, and private practice users, and which will likely be most reflective of the future installation mix. These are not necessarily the most active sites today. By showing you five running quarters, the idea is to show the rate of growth of same store sales. We will also continue to publish the install base, which we believe will function as an indicator of future utilization growth. The next point that I would like to talk about is the use of the MR by TELSA as there is a bit of confusion about that. It is true that as we started commercialization, finding compatible MR, available time, and convincing urology and radiology to work together to start a TELSA program has been a major hurdle to clients. However, today, Tulsa is compatible with an installed base of about 4,000 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 higher than that of any other treatment modality. Our relationship with MR companies also continues to expand as they see interventional MRs as a growth opportunity for them too. And we are delighted to be working with these large companies as partners with aligned goals. As we have talked about in 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 maintained, and can be placed just about anywhere since they don't need the same shielding as large magnets. The Siemens Free Series, which is a prime example of such an MR, is now available, and Cook Medical is partnering with them to provide a turnkey iMRI solution to hospitals. We believe that Tulsa is the natural king app for the interventional MR as it makes the economic justification of the IMRI suite very compelling. At this point, we anticipate that if all goes well, Tulsa will get FDA clearance for integration with the new interventional MR by year end, and we believe that this will meaningfully contribute to our growth in 2027. Considering all of this, we believe our goal of achieving 200 Tulsa sites performing an average of at least 50 cases per year to achieve profitability remains achievable, and we remain committed to this strategy. Finally, we would like to invite you to come visit us at the upcoming American Urological Society meeting that starts on Friday, May 15th in Washington, D.C. For the first time, there will be a real Siemens Free Series MR in our booth, and you will be able to see the future firsthand. To summarize, Profound is pioneering IMRI procedures, which enable precise, incision-free therapies that improve clinical confidence, procedure control, and patient outcomes. By leveraging real-time MRI guidance, Profound's technologies are designed to replace uncertainty with clarity across treatment planning, delivery, and confirmation. The TELSA Pro install base was 80 at the end of Q1, 2026, and we shipped an additional six systems during the first quarter that have yet to be installed. In prostate disease, we believe we're now crossing the chasm by transitioning Tulsa from early adopter customers to the mainstream market by establishing the technology as a third distinct category that doesn't make surgeons or their patients choose between whole-gland or focal therapies because Tulsa can do both and anything in between. As we said in today's press release, We are currently projecting total revenue full year 2026 to be approximately 25 million, which represents 56% growth compared to last year, together with 2026 growth margin of 70% or higher. We continue to believe that we are on the path to profitable growth. This ends our prepared remarks for today. With that, we're happy to take any questions you might have. Operator.

Thank you. Ladies and gentlemen, this will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the two. If you are using a speakerphone, please lift the handset before pressing any key. One moment, please, for your first question. Your first question comes from Ben Hainer with Lake Street Capital Markets. Please go ahead.

Good afternoon, gentlemen. Thanks for taking the questions. First off, for me, congrats on getting Humana to begin paying for this. Can you share any color on that? Is it the captain data that tipped them over? Is it anything specific that led to their coverage decision? And then where do you see kind of some of the other commercial payers in this whole progression?

Ben, thank you very much for the question. Can you hear me okay? This is Tom Tamburino.

I can, Tom. Thanks.

Okay, perfect. Just wanted to make certain. So, first, thank you for recognizing the tremendous announcement specific to Humana, and there are several others that we were able to gain coverage with here in Q1 of 2026 via the efforts of our health economics and market access team led by Kelly Perciucci and Tracy Davis. They did a phenomenal job. And what I can tell you, Ben, is that it is the combination of all of the publications, now 70 plus, That are allowing us to get an audience with the medical directors of private insurers here in the United States, and then leverage that data to have a discussion much like the position that Arun just stated as to where Tulsa Pro fits in and the continuum care for prostate disease. So it's not 1 specific thing. It's a compilation of all the work that's been done over the years to put us in the position we're in today. And we're very excited as the rate that we're seeing is roughly 1.5 to 2.5 X Medicare as it relates to private insurers based on the geographically appropriated gypsy rates, which is in line with what most industry standards would be.

Excellent. That's very helpful. And then I guess following up a little bit on that, do the folks that haven't announced, I guess, formal coverage policies, are you still seeing the same sort of General coverage that you have had been seen, you know, really up until now.

So, obviously, we go back to January 1st of 2025 when Medicare provided coverage for Tulsa pro, and that has allowed us to begin to have these discussions with the medical directors of the private insurers here in the United States. In combination to that, which should be no surprise, we also have a patient access team led by Stephanie Slater, and we do hand-to-hand combat with the private insurers on a case-by-case basis. We've been very successful, winning approximately 80% of the cases that we're involved with. My understanding of industry standard is somewhere between 50% to 60%. Again, I think that speaks to the talent of Stephanie, but also the growing body of evidence that Tulsa Pro is another tool in the armamentarium of physicians to treat prostate disease in between where focal therapy ends and prostatectomy and radiation begins is really where our sweet spot is starting to take fold.

Got it.

That's great.

And then lastly for me, just kind of housekeeping on the six shipments that were shipped but not installed. Do we expect those to hit revenue in the current quarter or was that something that would have been included in Q1 or half and half? How does that shake out?

Yeah. Ben, on that particular point, we're trying to sort of be a bit more granular than we have been. And, you know, I just want to clarify exactly what we're doing. So the total number of systems that we sold is eight. So eight systems were sold. Two of them were installed. So we increased the install base to 80. And then six of them were shipped, but they're not installed yet. And we do recognize revenue when we ship them, but we also realize that they won't be treating patients right away. And that's the reason why we made that distinction.

Okay. That's helpful. That's it for me. Thank you, guys, and I'll see you at AUA.

Beautiful, man. Thank you.

Your next question comes from Michael Freeman with Raymond James. Please go ahead.

Good afternoon, Matthew, Richard, Tom, Steve. Congratulations on the quarter. I wonder if we could talk about the guidance. We appreciate that you did set formal guidance here. I wonder if you could describe what informed this outlook. I recognize that this seems conservative relative to street expectations. I wonder if you could just give us a bit more color on how you came to this number.

Yeah, very, very happy to talk about this. So, you know, first of all, we are very bullish on our business. And in fact, we've never been more bullish and, you know, Tom can describe more about the pipeline as well. But to me, it is now about discipline. And, you know, we're putting a stake in the ground for the first time as proper guidance, right? We have provided targets before, but this is the first time we're putting a proper number at the table. And we will continue to work hard as we always do. And if we can drive it faster, we absolutely will. And if that happens, we will most certainly come back and hopefully increase the guidance. But I think, as I said, it really is that the business is gelling and we feel that we need to provide support appropriate discipline. So look at this as more of a starting point, and we will adjust as we go.

Okay. All right. Well, thank you.

Yeah, my next question was going to be on the status of the pipeline, so I would appreciate some commentary on your funnel.

Yeah. Tom can absolutely describe that.

My pleasure. Thank you. Michael, thank you for the question. So happy to report that our pipeline remains strong. It's north of triple digits across our verify, negotiate, and contracting stages of our sales process. And these pipeline accounts are representative of similar attributes to our index 20 that we've shared here today and will continue to share in the quarters that follow.

Okay. All right. Thank you very much.

Maybe the last one. I wonder if we could dig into the index a little bit, maybe describe, you know, I see that you provide, you know, averages of the index for utilization. How would you describe maybe the range on annualized procedures that we see in the index? And how do you plan to maintain this index? And will it be a rebalancing? Should there be outliers in the future? Any commentary would be helpful.

Sure. So, you know, again, we are trying to become as transparent as possible. This is our first shot at it. So let me provide a little bit more context. So what we really did was we said, okay, when the company matures and we have a bigger install base, what are the types of hospitals, large, small, private practice and so on, what would that mix look like? And then we sort of looked at the current install base and we segregated the sites that had one year experience. And so the 20 sites that we picked are really designed to reflect what we think the future install base will look like. So if we can demonstrate that the same store sales in these 20s are increasing quarter over quarter, and what we will do is we'll provide this rolling five quarters. So you will be able to see the change over basically the trend. And then as time goes on, we will go from an index of 20 to index of 30 to 50 to hopefully 200. So that's the idea. This is what we've just started. And it will allow you to sort of see that progress and hopefully it will mirror the future. Is that helpful?

It's very helpful and I appreciate you providing the index. I'm going to pass the line. Congratulations. Thank you.

As a reminder, if you wish to ask a question, please press star 1. Your next question comes from Scott McCauley with Paradigm Capital. Please go ahead.

Thanks, everyone. Thanks for taking the questions. I just wanted to check in on the capital sale model, whether or not, I know you've spoken in the past that that's kind of the preferred model going forward. Is that still the case, you're finding your potential customers interested in acquiring the capital versus more placement or lease model for the system?

Scott, thank you very much for the question. This is Tom answering. So our capital model is very much in line with what I believe to be industry standard from my experience is that roughly $100 of capital equals $10 of service equals $1 of consumables. So when we're speaking with hospital administrators, C-suite, CFO specifically, they totally get the way that we have the capital model situated. And that has been the large majority of the systems that we sold In Q1, we did sell eight systems. As Arun mentioned, two were installed, and six were shipped that were not installed. Out of those, only one was on the placement model that we spoke about with a bulk purchase. I believe we spoke about it in either Q3 or Q4's earnings call from 2025, and that represents roughly 10% of the recurring revenue for the quarter of Q1.

That's great. Super helpful. Thank you.

I know now you're talking about the guidance, the $25 million in revenue. I know in the past there's been reference to a target of approximately 120 installations I believe for the end of 2026. Is that 120 still representative of the target and help inform that $25 million revenue guidance for this year?

Yeah, so Scott, there's no change of any sort. We are still shooting for that 20, 120. We, as I said before, we are working hard to be much more disciplined and start to provide quantifiable information. in every place we can. And so there's no change in our pipeline. There's no change in our target installed. There's no change in the potential of our company. If anything, as I said, we remain really, really bullish. The number that I provided is just a stake in the ground that we put in.

uh so that we can you know anchor it someplace and adjust as we go so hopefully that addresses your your key question yeah appreciate that um and lastly um circling back to the reimbursement uh again great to see the the private payers uh starting to come in um any comment on uh the reimbursement rate that you're getting um if you're Happy with that kind of relative to what Medicare is paying and if you see kind of the humana rate as the target going forward as other private payers come online.

Yeah. So, Scott, as Tom mentioned already, what we are seeing is generally between 1.5 and 2.5 of what Medicare is paying. We are very happy with that range. The typical range is, again, from benchmark that we see is closer to 1.5, but we're pretty happy to see that in our case, some of them are actually even paying more than 2.5. So I think over the long haul, that range is a pretty good place to model. Just to provide a little more color on this, Humana is one of the top five payers, and so the way this process works, to some extent, as Tom already described, you're working hard to make sure any patient who's been rejected, that the appeal process goes on, and we see an 80% success rate in reversing those decisions. And now we have the first major pair that has put the coverage decision. So overall, Frankly, we are bullish about other insurance companies that will now start to follow suit from this as well. So I think generally speaking, it's the hardest to get the first big one. And I think Tom and his team did a great job to get there. And I do think that other insurance companies will follow.

That's great. And if I may squeeze in one last one, I apologize. Just in terms of the guidelines. So, I know being included in kind of AUA or other society guidelines is an important driver. I believe there have been some commentary around that being a kind of late 26, early 27 kind of goal, or at least seeing momentum there. Any update on that process?

Yeah, thank you for the question. This is Matthew speaking. So, on the guideline front, it's a continuous process and we described in whatever previous calls that the Tulsa procedure is now being named in the NCCN guidelines, which is probably the premier set of guidelines in this space. And so, so that's already a step in the right direction where Tulsa is being named by hand. They're recognizing the value of the Tulsa procedure under clinical trial or registry. We do have our international care registry where we invite. Um, you know, all of our sense to participate in. So we do see a lot of positive momentum from that together with as Tom and ruin were describing on the human aside. It does relate to the totality of evidence. It's not just captain. It's a top totality of evidence. And with the 70 peer reviewed publications, when insurance companies come to the table and do their literature searches, they do see that those publications come up and help them with their decision making. So, with Humana coming in, we do expect to see other insurance companies coming in based off of that. And as we continue to publish captain data, we do anticipate that whether it's the NCCN guidelines, the AUA guidelines, the EAU guidelines, they'll start to also recognize Tulsa by name and then start to recommend it for certain population subsets. And over time, we anticipate that to grow into larger population subsets as well. I'm not sure if that answers your question, but that's where we sort of see the progression of the guidelines.

Yeah, no, that's helpful. I appreciate it.

There are no further questions at this time. I will now turn the call over to Dr. Menawat for closing remarks. Please continue.

Thank you, and again, for those of you who can visit us at the American Urological Association meeting in Washington next week, please do join us, and we will have demos. We'll have the Siemens MR in the booth. We'll be describing how all of this will work together in an integrated fashion. Thank you again, and look forward to seeing you soon.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.