Profound Medical Corp.

Good day and thank you for standing by. Welcome to the Profound Medical Third Quarter 2023 Financial Results Conference Call. At this time, all participants are in a 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would like to hand the conference over to your first speaker today, 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 current beliefs, assumptions, and expectations. and relate to, among other things, expectations regarding the efficacy of the company's treatment technologies, results of future clinical trials, the ability to obtain coding and or reimbursement from third-party payers, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance, and future commitments. 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. For the benefit of those who are new to the Profound story, I would also like to take a moment to summarize our business. Profound developed and markets customizable incision-free therapies for the ablation of disease tissue. We are currently commercializing TulsaPro, a technology that combines real-time MRI, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control. The technology is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient's natural functional abilities. Tulsa Pro is CE marked, Health Canada approved, and 510K cleared by the FDA. In the U.S., we employ a pure recurring revenue model for Tulsa Pro, whereby we charge customers on a per-procedure basis for Tulsa Pro consumables, lease of medical devices, and services associated with expensive warranties. Outside of the United States, we primarily deploy a capital and consumable sales and service model separately, as the situation warrants that. We're also commercializing Sonalyse, an innovative therapeutic platform that is being marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalyse has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has recently obtained FDA approval under a humanitarian device exemption for the treatment of osteoid osteoma. The business model for Sonalyse systems is currently a one-time sale of the capital equipment. On the call today representing the company are Dr. Arun Menawat, Profound's Chief Executive Officer, and Rashed Dhawan, the Chief Financial Officer. With that said, I'll now turn the call over to Rashed.

Good afternoon, everyone, and welcome to our third quarter 2023 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 Arun in a moment for an update on our commercial activities. However, before I do, I would like to provide a brief update on our third quarter 2023 financial results. To streamline things, all of the numbers we'll refer to have been rounded, so they are approximate. For the three-month period ended September 30, 2023, the company recorded revenue of $1.7 million with the full amount coming from recurring revenue, representing an increase of 9% in recurring revenue compared to Q2 2023 and 40% compared to the same period of 2022. Total revenue last year's third quarter was $2 million, with $800,000 of that coming from one-time sale of capital equipment in international markets. Total operating expenses in the 2023 third quarter, which consists of R&D, G&E, and selling and distribution expenses, were $7.6 million, a decrease of 18% compared with $9.3 million in the third quarter of 2022. Breaking that down farther, expenditures for R&D were $3.4 million, a decrease of 28% compared to the third quarter of 2022. G&A expenses decreased by 15% to $2 million and selling and distribution expenses were $2.2 million, consistent with the same period of last year. Net finance income for the 2023 start quarter were $1 million, compared with net finance income of $3.3 million in the same three-month period of 2022. Overall, the company recorded a start quarter 2023 net loss of $5.6 million or $0.26 per common share, compared with a net loss of $5 million or $0.24 per common share for the same three-month period in 2022. As of September 30, 2023, Profound had cash of $33.6 million. With that, I will now turn the call over to Arun.

Thank you, Rashad, and good afternoon, everyone. Q3 2023 was our sixth consecutive quarter of recurring revenue growth, and our rolling four-quarter U.S. growth rate is at just over 60%. There are two main drivers of that trend. Despite TELSA still currently being predominantly private pay. First, our strategy to focus on educating our surgeons on the flexibility of TELSA in that it can be used to treat an unparalleled variety of prostate disease patients continues to show signs of success. Indeed, we saw more and more sites increase the variety of TELSA patients they treated in the third quarter. With respect to indications, approximately 57% were treated for prostate cancer, 32% were hybrid patients suffering from both cancer and BPH, 7% were salvage, and 4% were men with BPH only. TELSA is increasingly being used in patients who are diagnosed with prostate cancer but also have symptoms of BPH. We continue to see TELSA as the only viable minimally invasive option for such patients. The cancer grade Approximately 8% were grade group 1, 55% were grade group 2, 27% were grade group 3, and 10% were grade group 4 and grade group 5. In terms of ablation, around 60% were whole gland, 26% were subtotal, but more than half the gland, and 14% were focal therapy. The prostate size, approximately 2% were less than 20cc, 38% were 20 to 40cc, 31% were 40 to 60cc, 24% were 60 to 100cc, and 5% were over 100cc. We have been presenting this data to you on a quarterly basis. And there are two valuable dynamics worth watching. First, using TELSA, our surgeons have a choice of performing whole gland or partial gland therapy. And yet, 60% of patients treated are whole gland therapies, which tells us that TELSA is mostly about mainstream adoption as majority of cancer patient population require whole-grain therapy. And second, the number of patients being treated who have both diseases, cancer and BPH, is increasing. Treating such variety of populations is only possible with TELSA. That fact not only separates TELSA from the niche focal only therapy space, but is also helping the urology community gain an understanding that TELSA is poised to become a mainstream treatment alongside radical prostatectomy and radiation therapy. And that mainstream position for TELSA is coming at an opportune time. Since we announced the AMA's establishment of three new CPT-1 Category 1 codes for TELSA, which will be effective on January 1, 2025, we have started to see a change in market dynamics with providers who were previously reluctant to build out a cash-pay model now wanting to establish themselves as TELSA users ahead of the transition to a pair-paid model. A prime example of this is the Cleveland Clinic. Recognizing our strong clinical data, the flexibility of our technology, and that a CPT code is on the horizon, we have just signed a master agreement that will include over 20 sites. They intend to start with three sites, including their main site in Cleveland and their largest prostate cancer site in Western Florida. We're thrilled that one of the leading medical centers in the US recognizes the value of the technology and is preparing 14 months in advance to get many of their sites up and running. Going forward, we anticipate that newer TELSA sites will also be those that are looking to adopt TELSA for its pair pay model and not necessarily to build a cash pay practice. The second driver of our recurring revenue growth has been our low-cost, high-impact marketing efforts to educate patients. More and more, TELSA pro sites are telling us that patients are asking for TELSA by name. The number of hits to the TELSAprocedure.com website, which is designed for patient education, has increased by five-fold to approximately 40,000 per month in the last 18 months. Many international TELSA pro sites are also informing us that they are getting inquiries through our website. Supporting the efforts, the feedback from patients who have undergone TELSA remains extremely positive. helping to start making Tulsa a brand name with patients. On the product development front, we're also continuing to build the Tulsa AI brand aggressively. Tulsa AI is a brand name for software modules where each module is designed to perform a certain intelligent function elegantly. Thermal Boost, for which we received 510K clearance from the FDA this quarter is the first of those. Thermal boost allows a TELSA surgeon to provide extra heat at a tumor region if they suspect that there is extra capsular involvement or protuberance of the prostate tissue into the muscle of the patient. The thermal boost application has already been used by many sites with excellent reviews both in terms of usability for later stage disease patients as well as time savings. The next TELSA AI module we are working on is the Contouring Assistant. This is about audibility, the TELSA treatment design, in itself a game-changing technology. The module is already developed, and at the moment, we are in the clinical validation phase for FDA submission. The technology is such that it uses past treatment designs and recommends a design in a new procedure based upon that knowledge. We are already getting positive reviews from the physicians who are performing the clinical validation. As you know, our treatment and outcomes database will continue to grow and the knowledge of the AI will continue to increase and the proposed treatment design will continue to improve. We believe that this has the potential to also continue to improve outcomes even further and Tulsa is the only system that will have that capability. We have agreed with the FDA to conduct rigorous clinical analysis, a high bar that is normally set for diagnostic level AI software. Having such rigorous data analysis will give us significant flexibility to market the product in terms of critical outcome and time saving messaging. We continue to expect that we will gain FDA clearance in or around Q2 2024. Coming back to the dynamic that TELSA is increasingly being used to treat patients who also have BPH, we also announced at our recent analyst and investor day that we are developing a BPH-specific application using the core TELSA technology. This new application will also use the TELSA AI automated treatment design capability, which will allow our surgeons to custom design the treatment plan. We believe that the customization capability of TELSA, the fact that there is no blood loss risking the patient during the procedure, and TELSA's proven durability due to its prostate shrinkage over time will position it as a best-in-class treatment modality. We are making the information public at an early stage due to the request from our physicians, but we are not prepared to talk about further productization of the technology at this stage except to confirm that we believe that it will be a faster procedure we will make timing of the project available by next summer but in the meantime i can assure you that we're not talking about a project that will take several years to bring to market like it would for a new indication. TELSA is already cleared for the ablation of both malignant and benign tissue. And as such, there is a lot of clinical and safety data already available. To summarize, Our team has done extraordinary work in driving adoption of TELSA Pro so far. We are commercializing an autonomous robotic technology that is incision-free and radiation-free, results in no blood loss, doesn't require a hospital stay, and preserves a prostate disease patient's natural functional ability. Our AI initiative is advancing the technology further to create a continuous improvement technology, which we believe can break the barriers of today's accepted clinical outcomes. We have generated significant positive clinical data in various patient segments that have been confirmed by real-world data. Our hospital and early adopter surgeon partners have become experienced with the TELSA Pro system and can help to drive future adoption. We are thrilled to have partnered with leading hospitals as well as provider companies, such as RedNet, who have figured out how to use the MR not only for diagnosis, but also for treatment and create efficient patient care workflow that also optimizes economics. We have received overwhelmingly positive patient feedback. This is helping new patients to become educated and empowered. And our unique ability to customize treatment is a new concept that is resonating well with them and surgeons alike. The ANA has established EPT Category 1 codes that come into effect in January 2025. Our focus on investments in sales, marketing, and research and development is producing meaningful results. We believe Tulsa is proving to be the most versatile technology for prostate disease, with a total addressable market in the 600,000 patient range, which is greater than that for any other technology that can be used to treat patients with prostate cancer. We are thrilled that world-renowned Cleveland Clinic has recognized the value of our technology and has just signed a master agreement for over 20 sites. We are developing a set of software modules to further improve clinical outcomes, procedural planning, and time efficiency. We received FBA clearance for the first module thermal boost in the third quarter. We are targeting FDA clearance of our second module, a contouring assistant, later next year and believe that the clearance will allow us to more confidently enter the BPH space. This ends our prepared remarks for today. With that, Rashad and I are happy to take any questions you might have. Operator.

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. One moment while we compile the Q&A roster. Our first question comes from the line of Rahul Saragasar of Raymond James. Your line is now open.

good afternoon good afternoon good afternoon thanks so much for taking our questions um so congratulations on this uh cleveland clinic master agreement um a couple key questions there so you mentioned 20 sites uh with three uh up front so could you give us a little bit more color in terms of how you expect the cadence of that site deployments to roll out over the next year before Will it go into 2025 once CPT or will it all be rolled out by then?

No, I think our expectation is that we will, you know, get these first three sites going very, very quickly. And I don't think that we will be installing every site before, you know, 2025, but I do think that they are going to be educating their physicians at all of the sites so that by the time 2025 rolls out, you know, they can get ahead, you know, pretty good start. But, you know, I think realistically I don't expect that all the 20 sites will be operational before 2025. I think it's possible that there will be more than three by that time, but I would say for now, this is about the best that we have in terms of our plan.

Perfect. Thanks so much for that extra color. So, pivoting to the number of sites, you had previously indicated a goal of 50 sites by the end of this year. I believe there were 38 sites up and running last quarter. Would you possibly get an update on the number of sites deployed?

Yeah. So in terms of contracts, we have enough contracts to achieve 50. We have other couple of hospitals that are very big name hospitals that I have also found. In terms of installs we did in the third quarter, we added another three sites. We are working to get to the 50. It's more about coordination and so on. I think that, you know, overall, we remain optimistic to get to that number. And I think 2024, you know, again, our contracts continue. are doing very well. So we'll see how it goes in 2024, but I think certainly we are, you know, continuing to make progress in increasing the install base.

Great. Thanks very much. And if you'll indulge one last quick question. You highlighted at the analyst day the expansion of the BPH and provide a little bit more color today. talking about it likely to be a fast procedure. Of course, you said that you are going to be circumspect. But in terms of using the new contouring assistant, and do you expect that utility and BPH could essentially be beyond the hybrid or into just extremely large prostates? And what are we looking at in terms of the TAM there?

Yes. No, I'm happy to provide a little bit more color on that, Rahul. As I mentioned in the prepared remarks, this is more of a request that we were getting from physicians and patients. And when we did some research, what was interesting is that initially the paradigm was, well, you know, some of the technologies in BPH can be very fast and maybe, you know, patients and physicians, you know, it matters to them a lot. But as we did the work, what we actually found was that you know, certainly a BPH procedure will be much faster than a cancer procedure. But what they were really interested in was the aspect in terms of the prostate shrinkage, the aspect that if there is any lingering, you know, even early stage cancer, that it could be visualized and that the whole thing could be taken care of in one sitting with confidence because there is a good bit of clinical data And the fact that we have contouring assistance and modifying that, that to be able to do a very quick treatment plan that could really be customized to each prostate type. And to be honest, I cannot stress that point enough because prostates, as you know, can be smaller than 20 cc and larger than 100 cc. And not just the size, but also the shape. really matters. And so to be able to use our technology and really custom design to be sure that none of the vital functions are affected and at the same time enough tissue is ablated to be able to provide the patient with a durable treatment and do not have to worry about, you know, and see any cancer at that time at least. I think that's a value proposition. So I think, again, I feel very good about it. I think our team feels very good about it. I think that we will definitely start from the, you know, the larger prostates. But I think we will, you know, over time, look towards going into the mainstream as well.

Thanks. Thank you again for taking our questions. We'll get back to you.

Thank you, Rahul.

Thank you. One moment for the next question. Our next question comes from Ben Hainer of Alliance Global Partners. Your line is open.

Good afternoon, gentlemen. Thanks for taking the questions. First off, for me, I was curious on the hybrid cases that are being done. Are those more kind of incidental where you have a patient that, you know, has prostate cancer and also BPH and they would be operated on anyway, or is it more Patients that might have been candidates for watchful waiting and that might be, say, grade group one that are saying, well, let's kill two birds with one stone here and get rid of the cancer and hopefully solve the BPH as well. Any color on that group of patients?

Yeah. Ben, I think you're thinking in the right place. If you look at our data that we talk about every quarter, the number of patients who have early stage cancer and also have BPH, that's a segment that has been growing for us. And as you know, cancer is not a monofocal disease. It's a multifocal disease. And we can, you know, wherever it resides, we can get to it. And so the treatment designs that we are seeing for those types of patients are typically in the 50% to 80% ablation range. And they are ablating the tissue that normally causes the symptoms of BPH. And they're most certainly targeting explicitly BPH. where the cancer resides, and there's usually, you know, they add some safety margin to that so that there's a high level of confidence that the cancer is taken care of at the same time BPH is taken care of. So it really is both that they look to do, so it's a two-for-one. And as you might know, there's a large population of patients who are on active surveillance. You know, it's a million-plus And these patients also have BPH, many of them. And so that is the initial target market. And I think that's where that population that we're starting to see is growing and will be our market entry.

Okay. That's very helpful. Thank you for that. You know, I appreciate that you may not want to share kind of everything on this just yet. But on the BPH AI, you know, I think it was Dr. Hong during the investor day talking about how if you are going to do a volume similar to what's being done with TURP today, you could get a procedure done with Tulsa, you know, including a similar volume in, I think he said less than an hour if I understood him, properly, you know, just curious if, you know, that is, you know, reasonably accurate. And then also, you know, are the BPH cases that are being performed as we speak, are those informing what ultimately goes into the, you know, kind of contouring assistant BPH AI for the automation of the treatment plan? down the road?

Yes, Ben, I think you're on the absolutely, that's the idea is that we have, we think we can get the BPH done quite a bit faster with virtually no risk of any blood loss, which means that any comorbidities are not likely to be an issue. and I think, as you said, the base technology of contouring assistance will apply, and we are already gathering quite a bit of pure BPH patients as well as the hybrid patients, and we'll be able to apply those to the new type of patients. I think there is definitely enough information to be able to get it. I'm just a little bit because we are certainly very early stage, and I think I just want to make sure everybody recognizes that also. But the technology is there, and we're going to, you know, invest in getting it out as fast as we can. But we do need to get the contouring assistant, you know, FDA cleared.

Okay, good. That's helpful. I guess I'll leave it there. I mean, we just had the investor day, so lots of information already out there. Appreciate the question. Yes.

Thank you, Ben.

Thank you. One moment for our next question. Our next question comes from the line of Frank Takanan of Lake Street Capital Markets, LLC. Your line is now open.

Hey, this is Nelson Cox. This is Frank. Apologies if I missed it, but last quarter you mentioned seven signed purchase contracts and 15 late-stage prospects. Can you maybe update us on those two buckets?

Yes. I'm happy to. I think what I was saying earlier when Rahul was asking the question, we have enough contracts to be able to get to the 50 sites. And the problem with these numbers and so on, the reason I'm Saying it the way I'm saying it is, as you can tell from the prepared remarks, we have another major agreement with a number of sites. We also have a couple of other leading hospitals that we've signed with, big-name cancer hospitals. So it isn't about the pipeline. It's not about the number of contracts. I think the message that Tulsa is a versatile technology and that all these capabilities is getting there. So I think for us, the next stage is really streamlining the installation process, streamlining the startup, and ultimately, really, I think we're going to be in this transition phase at the moment when everyone is sort of waiting for 2025, when the reimbursement starts to kick in and so on. I think for us, it's really more about that dynamic at the moment. I think we will get the number of sites going. And I think these things that I'm talking about in terms of streamlining the startup process and so on, that's going to happen. It's just It's starting to happen. I think there are still a couple of sites where the MR installations are delayed. And so that, you know, a couple of them which were supposed to have happened in Q3 didn't, but they'll happen in Q4. So I hope you, I've sort of answered your question, but I hope you can see why, you know, the number of contracts is not an issue for us at this point.

Yeah, no, that makes sense. Thank you. And then one more quick one. With your youth skewing more heavily toward whole gland with your early users, how do you think about this concept over a long period of time? Do you think there could be a time where you only do hemi or whole, given you can effectively cover an area with limited quality of life risk?

Yeah, I think that's a very good question, actually. You know, one of the things that we have watched is As you know, there has been this paradigm, let's say, of latest technologies are for focal and things like that. And we have, you know, if a surgeon wants to do focal, we've always said, hey, you can do focal with this. But what we have witnessed over the last several months is that surgeons on their own are in fact ablating more of the prostates than they used to when they started out. What I mean by that is that more often than not, focal therapy can certainly ablate the index lesion properly, but there is always a risk that if you do not ablate enough of the prostate or that because it is not a monofocal disease normally, that there is cancer lingering around somewhere else. And so I think what we have watched is that the amount of ablative ablation of the prostate. Actually, we're watching them surgeons increase because they're getting more confident that they can save the vital functions and they're feeling more comfortable that they can go more towards higher volumes of ablation. And so I think you're right in the sense that I think as the physician community of the surgeons become more and more comfortable, chances are they will be ablating more of the prostate than less.

Well, congrats with the Cleveland partnership, and thanks for taking the question.

Thank you.

Thank you. As a reminder, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. One moment for our next question. Our next question comes from the line of Scott McCauley of Paradigm Capital. Your line is now open.

Good afternoon. Thanks for taking the question. Just one for me on risk staffing. As we ramp up these installations and support the early adopters who continue to start using it, do you expect you have the personnel capacity to support your pipeline, or do you think you're going to have to expand the HR base to help make sure everyone's up to speed quick enough?

Yeah, Scott, I think that's a great question. I think that, to be honest, we have a great team, to be honest. And I think that I've seen them in the crunch time install three sites in one week. So I know that we have the capability to do it. Our, you know, we are certainly also managing our cash very carefully, and you've seen from Rishad's presentation that, you know, in every function except for sales, you know, our costs are actually, our spend is actually down compared to a year ago. And at the moment, our expenses on the sales and marketing side are about the same as what we had this time last year. So the way you might think about this is that incrementally, as the schedules for installations increase, we will add people to our sales, marketing, and service functions. And we're trying to be a little bit ahead of that, obviously, to make sure our people are trained. So I think anticipate that incrementally, quarter over quarter, that's where the increase will be. But certainly, the revenue should catch up to that. And the revenue should be perhaps, you know, three to six months behind, you know, as we add the revenue and the sales and marketing function. So that's That's how you might think about it just a little bit far further. So we hired a little bit earlier. But we think we can now start adding people based upon, you know, the rate of installation growth.

That's great. Appreciate it. Congrats. And again, thanks for taking the question.

Thanks, Scott.

I am showing no further questions at this time. I would like to turn it back to Dr. Menawat for closing remarks.

Excellent. Thank you so much for your time and thank you for, you know, being part of this evolution. Talk to you next time.

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