Profound Medical Corp. (PRN) Earnings Call Transcript & Summary

Good morning, and welcome to the 43rd Annual JPMorgan Healthcare Conference. My name is Dave Praharaj, and I'm part of the health care investment banking team here at JPMorgan. Today, I have the pleasure of introducing our speaker, Arun Menawat, CEO and Chairman of Profound Medical. Here on the podium, we also have CFO, Rashad Dewan; and President, Mathieu Burtnyk. In terms of logistics for today, please reserve any questions for after the presentation. For those in the audience, mic will be passed around. For those viewing on the web, please submit your questions online, and I'll be able to view them through the iPad on stage. With that, take it away, Arun.

Thank you, Dave. Thank you for inviting us to the JPMorgan conference, and thank you all for joining us this morning, and for those who are on the webcast. I'm delighted to kind of give you an update on Profound Medical. So our mission is to bring -- commercialize incision-free ablative treatments using an MRI. And TULSA is our first primary product that we're commercializing, and it is designed to be an ablative treatment for prostate cancer or benign treatment for BPH-type applications. So our product was FDA cleared in August of 2019. We began commercialization in 2020, but we've been upgrading the product and the AI version of the product was FDA cleared in May of 2024. We've treated well over 3,000 patients so far. We have well over 50 sites in the U.S. We are treating at the rate of just over 1,000 patients per year at the moment. It's visible in our recurring revenues that you might see in our public documents. But the patients that we've been treating so far have typically been paying between $30,000 to $35,000 cash. And as of January this year, CMS has approved and the reimbursement has been established, and it is higher than actually that of any of the reimbursement for any other prostate procedure. So we're delighted to have sort of gone through the start-up phase and now we're entering the growth phase of the company. We are public on NASDAQ and the TSX in Canada. We obviously invite you to really review all of the documents, all our forward-looking statements. I will talk a little bit about where we're going in the future and so on and please review all of our risks associated with it as you make your investment decisions. So let me start with what is the unmet need here. The prostate's unmet need is really the fact that it's one of the largest cancers, but about 20% of the men who undergo today's treatments like prostatectomy or radiation undergo have incontinence and about 50% of the patients have erectile dysfunction. And the reason behind all of this is purely anatomy. The anatomy meaning, if you look at the cartoon at the bottom left, what you will see is that the nerve bundles that control these functions are right underneath the prostate. And when you're taking the prostate out, these nerve bundles get cut, and the buff-colored muscles, these are the sphincter muscles that control incontinence also get damaged, particularly when you're doing prostatectomy, you have to pull them all the way to the bladder to connect the urethra to cover that space that's been created and that is what causes these problems. And so our treatment is actually quite different and quite unique in the sense that we start by putting the patient in an MRI. And so it is completely visible to the urologist when they are treating our patients the images show up on the screen of the patient's prostate, and you can see that at the bottom left. And using that, our latest AI technology, they click a button and the boundaries of the prostate in yellow lines are clearly visible to them. And so they can either accept the boundaries or they can adjust them as they see fit. But the idea is it's highly reproducible, highly controlled, and they have visibility to where the nerve bundles are, where those sphincter muscles are as well. And then we're inserting a catheter right into the -- through the urethra into the center of the prostate. So the treatment itself is quite unique. So what happens is that the catheter sends out, you see from this yellow flame like, it's actually a set of ultrasound transducers that send out a wave of sound. And that wave of sound gets absorbed by the tissue, and that absorption increases temperature 1 degree at a time. So slowly, the temperature is increasing. The MR not only provides the images, but also provides the temperature map in real time. And automatically, it controls that rate of heatment by adjusting the volume, the robot controls all of that. And so in about 40 minutes that catheter rotates, and it kills or heats up the tissue to 55 to 57 degrees to kill the tissue. And that process is completely autonomous. The surgeon basically is watching the screen during that phase. And it's color-coded. So yellow color clearly tells them that it's -- the tissue is dead. We're not overheating, we're not underheating, and that is part of the key to the success of this procedure. So here it is in a video. So the patient is in the MRI. You'll see the catheter going in, into the center of the urethra and the blade -- the images -- cross-sectional images from the MR are visible on the screen and the boundaries are drawn, and you can see the rotation of the sound and the color gets generated, what you're watching on the screen is real patient data that's being treated. And you can see completely the precision with which it treats. The blue color that you see in the center is because when you're -- when we're treating the patient, the catheter in the center has water flowing right through it, so that the urethra is always maintained at body temperature and thereby, we're not killing the urethra. So the natural function of the patient's urination is completely maintained. So what does this mean? First, it's truly see and treat. So the physicians have phenomenal confidence. They know what they have killed. They know what they have kept alive very, very clearly. But it means a lot to the patient. Number one, minimal side effects, right? Our clinical data is very strong. We save those nerve bundles. We save that sphincter muscle that controls urination. Number two, no blood loss, completely no blood loss. And patients do not report pain after the -- most people will not even need a prescription-grade pain killer. If the patient is on a blood thinner, they do not need to come off of a blood thinner. And think about these are older men, they may have comorbidities, right? They are going in 3 to 4 hours, they get this patient -- treatment done, they go home same day, no hospital stay, no blood loss, minimal pain, if any. And most people, in fact, go and have dinner with their families, they go out to a restaurant the same day. So what I've talked about 7 years ago that someday, a patient can actually be diagnosed in the morning, be treated in the afternoon and go home and tell the family that they were diagnosed but they are cancer-free by the same evening. That is -- that vision is very, very real for us. So very quickly then, this is the AI treatment. The images show up, they click, the treatment -- the prostate boundaries are visible. They can adjust if they choose to, but very, very quickly, they can do the treatment design. And this is, again, a real patient. This is the real monitor. During the treatment, they are watching the screen, this is the surgeon. And quite frankly, they can be drinking coffee while the patient is being treated, and they can be answering text and so on. And one of the things that I mentioned because of the fact that we do not overheat, what happens is that the dead tissue just gets reabsorbed by the body. And so the prostate over time shrinks. The clinical data that we have showed that the prostate shrinks by about 92%. So the rest of the prostate just shrinks around the urethra. So this is incredibly unique technology. It took us time to actually learn how to use it ourselves. But now we have 67 publications. We have over 200 conference presentations. And these publications cover a whole wide variety of range of patients that can be treated with this technology. So certainly, we can treat whole gland, and whole gland is the standard of care, and that is where most of our data is that we can compare whole gland treatment using our technology with radical prostatectomy or radiation treatments. But we can treat large prostates, we can treat BPH, we can treat patients who we call hybrids who have BPH and early stage disease who don't want to be on active surveillance, and they want to be treated for BPH. They can get treated. If they want partial gland treatment, they can do that as well. And most certainly, we treat a number of patients who have failed radiation treatment also. So this is a technology because of its precision and its ability to design the treatment allows a physician to have an incredibly flexible, but at the same time, a precise tool to be able to manage the disease in a way that is optimal for that patient. And you can see the clinical data that we have is in a full range of different types of patient population. And I'm very proud of that because we think that to be able to drive adoption, you need this wide variety of patient data. So the clinical data is very strong. We have 5- to 7-year outcomes. Basically, it shows that we virtually eliminate the incontinence problem. We have very few patients who will have what we consider low-grade erectile dysfunction that is treatable by Viagra, Cialis-type disease. We do not have -- we had 0% severe ED that is not treatable. And on the BPH side, we are starting to gather quite a bit of data. And again, as I mentioned, the prostate shrink over time so it becomes a very durable treatment for patients who have BPH as well. The data that I really like is this page because this is real-world commercially treated patients. And what you see on the bottom bar is, although when we started, the original data was on intermediate risk patients. But our physicians have started to treat higher risk disease, lower-risk disease, small prostates, large prostates. Over 60% of the patients that are treated are in fact whole gland, but then there are about 20% patients that are treated that are 50% to 99% ablations and maybe about 20% that are what is traditionally called focal therapy, which is 1/4 of the gland or less. And then certainly, a majority of our patients today are prostate cancer patients, but where the side of the market for BPH or these hybrid patients is actually increasing quite nicely for us. And so when we started to look at how they are treating these patients with late-stage disease, we are software driven as a company. And so we have -- we introduced another AI module called Thermal Boost, and it allows the physicians to go to the boundaries of the prostate and really be sure that the boundaries or the outer edge of the prostate is completely cancer free. And what was interesting is today, it's been out for a year and 50% of the patients they are treating, they're actually using this software module as they do the treatment. And so it gives them further confidence. And this is part of our strategy is that we're looking at clinically relevant information constantly to see what can we do to help this tool become even more flexible and clinically more important to them. And this is just one example of that. So I mentioned BPH to you. But let me just finish the prostate cancer part first, which is that we think that this technology would apply to about 200,000 patients. And on average, we charge about $8,000 per patient. So we think that there's a very good TAM of $1.6 million. Our margins are already over 60%. We think over time, they'll get to well over 70% with this business, and we think we have a very good runway to get to this TAM now with reimbursement. For BPH, we are actually developing a unique module that will automatically then just like for cancer, it shows the outer boundaries; for BPH, it will show the sections of the prostate, the transition zone, which is overgrows and that causes the BPH. It is design complete, and we expect to commercialize this summer. So this is not long term. This is just same hardware, same overall process, but it will be much faster because we're not treating the whole prostate, and it will very quickly automatically define the transition zone of the prostate. And the fact that we have MR images, we can be incredibly precise we can -- in some patients, they can treat 30% of the organ; in some, they can go to 50% or higher if they choose to. And in some cases, if they suspect that there is a region where there's some cancer, they can modify the treatment plan and be able to do that. And so if we just look at the extreme end of the market, which are patients with the most severe disease and some hybrid patients where they may have both of these diseases, that alone is over 400,000, which means that our TAM overall will get tripled by this summer. And so we're quite excited to be bringing that new software module to the market this summer. Now during that early phase, as I mentioned, $30,000 to $35,000 is what a patient has paid. About 25% of the patients were getting reimbursed through a C code particularly at large hospitals. But we think that allowed us to really capture leading hospitals in the country and certain imaging centers that can now start to look at growing this with reimbursement. So for reimbursement, they have defined 3 codes in situations where there might be a radiologist and a urologist that choose to partner and then they don't have to spend as much time individually, but they can then treat with a much more rapid pace. And then for those situations, there's 1 surgeon, there's 1 CPT code. So it allows for the flexibility to be able to organize what's best for hospitals where they might want to have 2 physicians and for smaller hospitals or ASCs or practices where they want to have 1 physician do the whole thing. What's interesting about our reimbursement is that we are -- this reimbursement is the only one that from a very practical perspective but for a real perspective is really good at ASCs. And ASCs is where most people want to do these procedures because it's a day procedure and as I said, no blood loss, no hospital stay and a daytime procedure with imaging, it's just very suitable for ASCs. And so when you look at the reimbursement that has been approved, TULSA reimbursement, the first line that you see, if you look at the hospital payment, $12,992, almost $13,000, it's -- compared that to radical prostatectomy which is at $10,400. So significantly better than where prostatectomy is. But what's interesting is that even at ASCs, you see this reimbursement is at $10,700, which is even higher than what it is for prostatectomy in a hospital setting. So we think that this will allow us to open the doors to ASCs as well. I have no doubt that hospitals will want this obviously, but I also think that we can open the door to ASCs where patients actually prefer to just go to a smaller center, get treated and go home. So we're pleased with what the startup is. The reimbursement for the physician is pretty competitive with what it is for other types of treatments. There is a little bit of confusion because our treatment reimbursement is 0-day global. So when you add 90 days, which is where everybody else happens to be because these are multiple visits, in our case, every visit would be paid for on its own. And so when you add up all of this, our payment is at about $918, the other payments are a little bit over $1,000. But the difference is that there's about a 20% lower less time required with our procedure. So CMS is paying for 222 minutes; for our procedure, they're paying for 300 minutes for robotics in fact, right? And that difference is large enough that many of the physicians are saying they can actually do one case more in one day because saving 5 or 10 minutes is interesting. But when you're saving 20% in a procedure and you can then do more cases in a day that actually means higher dollars in the pocketbook for the physicians or more productivity for the physicians as well as the hospital. So we're thrilled with that as well, obviously. So there's quite a bit of information coming up. For 2025, number one, we are the first company that really started the clinical trial in prostate cancer, where we are comparing whole gland treatment using TULSA to radical prostatectomy, and it's a randomized control trial that's about as good as it gets in a medical device space. It is recruitment complete, and the first set of perioperative data will be public at the AUA in late April this year. So we're thrilled that, that data is coming up. The second thing we're thrilled with is the fact that Siemens sort of appreciated the fact that we're one of the companies that is bringing MR to the surgical suite, and they have created an MR called the Free.Max. It's almost half the price of a regular MR. They've heavily used AI. We're thrilled with the way they've gone about it. But because it's lower magnetic strength, it is much lighter in weight. It's -- the size and shape is such that you don't need to break walls, you can just move it through corridors, and it still gives you diagnostic-grade image quality. And so we've partnered with them. It allows our salespeople to provide a full solution with an MR and TULSA. So we call it a TULSA + solution, and we're delighted to be now beginning to market that in 2025. So summarizing, TULSA is incredibly flexible and incredibly precise. We have over 67 publications. So we have a large body of clinical evidence. There are not many physicians who are really concerned about our clinical data. I think we've crossed that hurdle very nicely. We're thrilled to be bringing BPH to the market by summer this year. We are thrilled with the Siemens agreement, and we are obviously happy that we are finally at the stage where the product can be reimbursed. So one question that you might ask is, well, okay, so this is -- it looks like things are coming along. What does this mean in dollars and cents. And I think that what I can tell you is between 2023 and 2024, we grew at about 57% to 60% rate. And we, certainly, based upon where we are in terms of the pipeline, I think expecting that we can grow 60% or higher is reasonable. I don't see this as a forecast or guidance at the moment. I think it's just getting started right now. But I do think that I'm just expecting that we can go in high-double digits. Growth rate is a fairly reasonable expectation. And I do think that sometime in March when we do our year-end or maybe even at the end of Q1, we will have a lot more information on how this changes getting adoption, and we will provide far more clearer at that point real guidance. But at this point, we do think that expecting that we can continue to grow in high double digits is a reasonable expectation. And the last thing I wanted to go through is, you've seen how we've built this business quite methodically making sure the technology really works, making sure we've trained the urologist properly, education has been a big part of how we've gotten here, getting the leading hospitals to support, which in turn supported a good reimbursement with CMS and so on, all that has been done. And so even though we're still at early stage, and we will -- we've built a great sales team now that we will grow, people have asked like what's next? And so I can tell you 2 things. One, 99% of our investment dollars that we get from investors is going into prostate. Number two, we do have a phenomenal pipeline. And it is actually funded by research grants. So in this pipeline, we have actually an FDA HDE approved product for pediatric application. We didn't put a sales team together for it. So we have not sold much. We have sold a couple of systems through that. But we are in a Phase I/II clinical trial in pancreatic cancer. A number of people have asked that question. We've actually treated over 5 patients already. It's a 25-patient trial. We think by end of the year we should be able to provide some data on this trial. We're pretty happy with where we are. So far, it is done in Cologne, Germany. Another one that we're quite excited about is a trial where they're doing histotripsy plus the cancer immune drugs together using our device. And this is being done at [ Utrecht ] and again, funded by research grants, and they have treated a number of patients, at least 5 or 6 patients already, and these are primarily metastatic cancer patients, and we're looking to as a life extension as outcomes for them. So yes, there is a phenomenal pipeline that is possible. And some of these are quite compelling applications also. But at the same time, we have a very, very good application with TULSA in prostate and that is where we're investing our dollars today. Over the long haul, I fully believe that we will be a platform company. With that, I'm going to finish and open for any questions.

Happy to kick things off. Maybe you can touch a little bit on your -- on the competitive landscape and how your device is differentiated.

Yes. Dave, that's a very good question actually. A number of people do ask that. So competitive landscape for us is a little bit of not just technology differences but also philosophy or clinical messaging differences. So if you don't mind, I'm going to sort of go over both of those for you. So the first difference is that there is a -- among urologists, there's this conversation that is going on, which is about is prostate better treated as whole gland treatment or as partial gland or focal treatment. And I think that debate has been going on for 20-plus years. And many of them think that partial treatment or focal treatment is good for maybe 10% to 20% of the patient population; and the rest of it, about 80% of the patients treat whole gland. And so when we think about competition, in the whole gland space, there really is no -- we're the next one up. We're the only one that can treat whole gland in a very efficient manner that you saw in the presentation. And so if a patient needs whole gland treatment or near whole gland treatment, we think the opportunities or options are prostatectomy, radiation, TULSA. Now there's this whole other place of what they call focal treatment. And that's where that philosophy comes in. In Europe, this partial gland -- so the idea of focal is not a bad idea. The technologies in focal are not bad technologies. They're good technologies. But really, there have been many, they're probably 10 of them that have been commercialized for the last 20 years. And at the end of the day, quite frankly, none of them have really taken off. And the rationale is that in focal treatment cancer comes back. And so the physicians, particularly in the U.S., are saying, well, if I can get a technology that is flexible that I can treat majority of my patients with whole gland and those few that do qualify for focal, if I can use TULSA for both then that option becomes very interesting. But the focal therapies, you can see [ electroporation ], you can see HIFU, you can see photodynamic therapies, you see cryo, you even see radioactive seeds. So a number of them have come for the last, as I said, 20-plus years. And really, the hurdle is not necessarily the technology itself is that philosophy of is focal therapy really going to become mainstream. And I think we -- when we talk to urologists, we can basically say to them is, quite frankly, we're agnostic to it because we think that whole gland or partial gland are both possible. I have to say, when I look at the clinical data, I think that if you can do whole gland treatment and save the nerve bundles and save the urethra and the sphincter muscles, it probably is a better way to go. And I think most people know that I am a former TULSA patient, and I had whole gland exactly for the same reason.

And I guess double-clicking on the whole gland versus partial gland. If you look at a busy urology practice, for example, what's kind of the breakdown between the 2 right now?

So we track quite a bit of data and practices that are -- we have a few physicians, maybe less than 5, but certainly in that range that have decided that they will do nothing but TULSA because of that flexibility. And we also have teaching hospitals where at least 25% of the patients even during this cash pay phase were undergoing TULSA treatment. So expecting that 25% of the TAM is there is available even in those at this early stage, quite frankly, is pleasing to us. Because when you look at, for example, radical prostatectomy or radiation, they have about 35% of the market each. So if we can be at 25% in these sites, which, as you said, I think, is the right way to think about it is the sites that are -- that have adopted TULSA even at early stage at 25%, it's pretty good. And then as I said, a few of them are just saying, "I'm going to do nothing but TULSA procedure." So I think expecting that we could be a third option and be in that range of the big 2 is not out of the realm possibilities.