Profound Medical Corp.

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 statements, 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 develops 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, Lisa 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 Sonolise, an innovative therapeutic platform that is being marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonolise 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 Saad Ali's system is currently a one-time sale of the capital equipment. On the call today, representing the company are Dr. Arun Menawat, Kaplan's Chief Executive Officer, and Rashed Dhawan, the Chief Saad National Officer. With that said, I'll now turn the call over to Rashed.

Good afternoon, everyone, and welcome to our second quarter 2020 free 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 second 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 June 30, 2023, the company recorded revenue of $1.6 million, with the full amount coming from recurring revenue representing an increase of 38% from $1.2 million in the same period of 2022. Total revenue in the last year's second quarter was $2 million, with $864,000 of that coming from one-time sale of capital equipment in international markets. Total operating expenses in the 2023 second quarter, which consists of R&D, G&A, and selling and distribution expenses, were $7.5 million, a decrease of 14% compared with $8.7 million in the second quarter of 2022. Breaking that down further, expenditures for R&D were $3.2 million, a decrease of 14% compared to the second quarter of 2022. G&E expenses decreased by 21% to $2.1 million and selling and distribution expenses decreased by 6% to $2.3 million. Net finance cost for the 2023 second quarter were $884,000 compared with net finance income of $1.9 million in the same three-month period of 2022. Overall, the company recorded a second quarter 2023 net loss of $7.4 million or $0.35 per common share compared with net loss of $5.9 million or $0.28 per common share for the same three-month period in 2022. As at June 30, 2023, Profound had cash of $39.3 million. With that, I will now turn the call over to Ruth.

Thank you, Rashed, and good afternoon, everyone. At the beginning of the year, we identified certain goals that we want to achieve this year to achieve our main objective of driving adoption of the TELSA procedure for patients with prostate disease in the United States. At this mid-year point, I would like to start by discussing where we are against these goals. First and foremost, we indicated that we anticipated that the growth of the TELSAT procedures in the United States would kick up to about 5% per month in 2023. By framing it as a monthly basis, part of our intention was to highlight the predictability of our recurring revenue business model. As compared to Q1 2023, the US recurring revenue grew by 21% in Q2 2023. Comparing the first half of 2022 versus the first half of 2023, the US recurring revenue grew by 63%. Based upon these results, we remain comfortable that our U.S. business will continue to grow at a similar or better pace in the second half of this year, delivering U.S. revenue growth of about 70% over last year. We realize that these numbers have a small base, but our benchmarks indicate that acceleration of the growth rate in the upper double digits is the right expectation at this stage of the company where the primary mode of payment remains cash pay. 70% of our patients today remain cash pay patients and are typically paying over $30,000 per procedure. The second expectation was that we would apply and receive approval of category one CPT codes specifically for the TELSA procedure. And as you already know, that goal was achieved in June. With sponsorship, and support from multiple physician specialty societies, the ANA established three new Category 1 codes for TELSON, which will be effective on January 1, 2025. The first code is for procedure performed by specialists, such as a urologist, without assistance from another specialist. The other two codes are for a procedure performed by two physicians, such as a urologist and a radiologist. We believe having multiple codes gives our physician users the flexibility to either do the whole procedure or collaborate and get reimbursed for their part of the service. The next step of the CPT application process involves the Relative Value Scale Updates Committee, or RUC, sending questionnaires to TELSA users to determine the physician's work-related value units, or RVUs, associated with the TELSA procedure. Both the SIR and the AUA will be very involved in this process, which along with reviewers by the Center of Medicare and Medicaid Services, or CMS, will ultimately determine the PELSA procedure payment amount. For reference, the U.S. hospitals performing the PELSA procedure on Medicare patients are currently utilizing HCPCS code C9734 established by the US Centers for Hospital Outpatient Prospective Payment System and reimbursement to a hospital billing under this code is $13,048. The proposed recommendations are expected to be published in the Federal Register in August 2024, finalized in October 2024, and come into effect as of January 2025. The third goal was about increasing the size of the install base given that our U.S. business model is about getting paid on a per-patient basis a larger install date in preparation of January 25, when the Category 1 CPP code will become effective, will be important to drive faster growth in the future. Today, we have an install date of 38 systems, and additional seven contracts to be installed and a pipeline in the final stages of 15 additional installations. All together, this gives us confidence that we will meet the expected install base of 50 systems by end of this year. Indeed, none of the U.S. business objectives or deliverables for the remainder of 2022, have changed. The non-US business, however, is all about capital revenue, which is always unpredictable in the early stages and is even more so in our case since we have chosen to increase our sales and marketing investments in the US and not in the international market. Having said that, we do expect that our install base in certain countries, including the important market of Japan, will increase in the second half of 2023. Turning to our utilization metrics, over the last two quarters, I have talked about the variety of patients that are being treated using Tulsa technology. we continue to see that more and more sites are increasing the variety of Tulsa patients they are treating. With respect to indication, approximately 66% were treated for prostate cancer, 25% were hybrid patients suffering from both cancer and BPH, 7% were salvaged and 2% were men with BPH only. TALSA is increasingly being used in patients who are on active surveillance or diagnosed with low-grade cancer but also have symptoms of BPH. We continue to see TALSA as the only minimally invasive option for such patients. For cancer grade, approximately 14% were grade group 1, 60% were grade group 2, 17% were grade group 3, and 9% were grade group 4 and grade group 5. In terms of ablation, around 60% were whole gland, 24% were greater than 50%, but less than 100%, and 16% were focal therapies. For prostate size, approximately 4% were less than 20 cc, 34% were between 20 to 40 cc, 37% were between 40 to 60 cc, 20% were between 60 to 100 cc, and 5% were over 100 cc. Based upon these results, clearly, TELSA continues to be used in a wide variety of patients with prostate disease, and we continue to believe that the total addressable market for Chelsea is about 600,000 patients, which is larger than that of any other technology that can be used to treat patients with prostate cancer. Finally, I would like to provide an update on the TACT pivotal study, which has reached the end of five-year follow-up duration, and the results demonstrate the predictability and durability of the TELSA procedure. By five years, median prostate-specific antigen, or PSA, was 0.63 nanograms per milliliter, and only 21% of patients received additional treatment for prostate cancer without unexpected complications. The latter outcome is especially compelling as it falls in line with the one-year biopsy data and compares well with similar rates reported after radical prostatectomy in intermediate risk men in several publications, including the PIVOT randomized controlled trial and the CAPTURE registry, one of the largest databases of prostate cancers in the United States. Although, this outcome was achieved despite the fact that a second TELSA ablation was not permitted by protocol. Since the early days of TACT, physician experience and protocols for patient selection and treatment have been refined and on review, the risk of failure is mitigated by modern management approaches. Additionally, we have been able to demonstrate that data from intra-procedural thermo MRI imaging and early clinical follow-up can indeed predict the risk of solid therapy by five years. The five-year outcomes in the TAC study also establish the durability of the favorable safety and functional outcomes that were achieved by one year. For urinary incontinence, 92% of patients who were tag-free before Tulsa remained so at five years, stable from one year. This is consistent with natural decline in function typically observed in men of this age over this time period as reported, for example, in the observation arm of the pivot randomized controlled trial. For erection function, zero men experienced grade three severe erectile dysfunction, where medication is not helpful. And 87% of men preserved baseline erections sufficient for penetration by the five-year visit. there were no attributable, gravely severe or serious adverse events reported from two to five years. To summarize, most of the boxes for increased adoption of TELSA Pro have now been checked. While reporting of preliminary five-year results from the TAC trial comes within the context of increased awareness of the high incontinence and erectile dysfunction side effect rates with radical prostatectomy and radiation treatment. The preliminary five-year TAC data demonstrates that one-year safety, efficacy, functionality, and salvage therapy risk outcomes are predictive of the same outcomes at five years. This is encouraging, as we expect in Q1 2025 initial data from our ongoing Level 1 Captain Clinical Trial. TELSA continues to be unrivaled in the types and numbers of prostate disease patients that urologists are using to treat prostate disease safely and effectively. With 38 TELSA pro sites comprised of top tier hospitals, independent corporate centers, and opinion leading practices, we now have a large number of experienced physicians, especially neurologists, who are ready to lead adoption of TulsaPro. We remain on track to grow our install base to 50 TulsaPro sites by the end of 2023, and at least 75 by the end of 2024. L-Cepro offers a price point of over $8,000 per patient. Our recurring revenue has grown for five consecutive quarters, and we expect that to continue going forward. Our recurring revenue model already yields high gross margins of around 65%, and we think they will potentially exceed 75% in future with increased volume. We are delighted with the AMAs establishment of three new CPT Category 1 codes for Tulsa, which will be effective on January 1, 2025, and look forward to the next stage of the CPT process. Finally, we continue to believe that the establishment of the permanent reimbursement codes combined with initial data from the CAPTCAN clinical trial will serve as a significant catalyst for TELSA adoption in the U.S. beginning in the first quarter of 2025. This ends our prepared remarks for today. With that, Racheb and I are happy to take any questions you might have.

Thank you. We will now conduct the question and answer session. To ask a question, please 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 Rahul Sarugase from Raymond James. Please go ahead.

Good afternoon, Arun. Good afternoon, Rashad. Thank you so much for taking our questions. And let me start by saying congratulations on getting the PPT codes this quarter. So my question is, it's nice to see the growth from 34 to 38 devices this quarter. Looking that you'll need to grow by an average of six more devices per quarter to get to the year-end goal of 50, and also given that now that you have the CPT codes in hand and granted that they'll come into force in just over a year from now, are you seeing growing momentum among hospitals and docs for the installation that you think will be a tailwind to these installations?

Hey, good afternoon, Raul. Yes. Yeah, I think that message is relatively new, but it is definitely impacting the pipeline that we're building. The pipeline that I talked about in the prepared remarks of, you know, about the 15 systems that are in the final stages or the seven contracts that we additionally have, that I would say, you know, was work that was done prior to that news. But yeah, I think the answer to your question, you know, short answer is definitely we're seeing very positive feedback about the permanent code and most certainly more and more of the urologists are interested in learning about it and also getting trained on it.

Terrific. Thank you very much for that, Arun. So my second question, still staying on reimbursement, is there was some discussion last time about potential expansion of the existing C code 9734 to emulatory centers. Would you be able to perhaps share an update on that?

Sure. Raul, I would call it sort of work in progress. I think we will know sometime in October, early October. As I mentioned before, the data supports the expansion and So, you know, we are in dialogue. We're continuing to be in dialogue with CMS. It's kind of hard to put the odds in at the moment. It could be that, hey, they are saying, well, a year from now you'll have a permanent code which will be effective in ASCs and so on also. So they may feel like this is a generic code and they don't want to go there. But on the other hand, the data strongly supports the request and it's not a major change for them to make. So I think I would say stay tuned. I certainly don't think that it's a lost cause. I think it's just work in progress and we do have a strong case.

Perfect. Thanks very much. And if you don't, just one last quick question. It's interesting to see the broadening use right through active surveillance, BPH, through salvage, and of course, the range and sizes of prostates that are being treated. So now, so translating this to the CAPT and trial, and of course, recruitment, How do you see recruitment playing out in that trial? Are you still looking at early 2025 for initial read on that data? And what can we be looking for in these utilization numbers that you outlined today, as you hopefully will continue to do, as sort of leading indicators leading into that captain readout?

Yeah, Raul, that's a great question, actually. First of all, we are really, really focused on the U.S. business at this point. And so the growth rates that I've talked about are U.S. growth rates. And as the experience of the U.S. community is increasing, I explicitly think you're right is that We're finding that there's a subset of population, which is actually a very large subset, which is patients who have BPH symptoms and need a procedure but also have cancer. And that happens to be low-grade cancer. So normally they don't get treated and they're on drugs and they're suffering from the psychological trauma of having cancer and they're suffering from the symptoms of BPH. That subset we think is an amazing sweet spot for Tulsa. So I think we are going to see more and more of that. Captain clinical trial is really because it's designed to be a level one study head to head with prostatectomy. The patient population in that trial is more aligned with what more traditional intermediate risk or higher risk patients. So I think at some point we will be publishing more data on that other subset of the population. But the captain trial itself is actually more head-to-head against radical prostatectomy. So the patient selection criteria there is similar to, you know, normal prostate cancer patient who would be treated. And finally, you're right, we will... we do expect that we will have the preliminary results in early 2025. Again, just to highlight one more thing again, that the most important thing that we learned from TACT that I talked about in the prepared remarks, is the predictability of the results so that we'll be able to discuss with payers as well as urologists about the fact that, hey, the data, it was predictable in TAG. There's no reason why that should not be the same. So even the early results should be impactful.

That's an important distinction. Thank you very much, Jeroen. And thank you again for taking our questions. We'll get back to the Q&A.

Thank you, Ali.

Thank you. One moment for our next question. Our next question comes from Michael Saccone from Jefferies. Please go ahead.

Hey, guys. This is Chris on for Mike. Thanks for taking the question. I was wondering if you could give an update on the broader macro environment and the backdrop for system installs. Any challenges or bright spots to call out there?

Chris, good afternoon. I don't know if I have too much of a commentary. I think that the pipeline is pretty strong. I don't think the macro environment is affecting us that much. I think that the recognition that this technology is flexible and has tremendous potential from this variety of patients, which I talk about all the time with our urologists and here. I think that message is definitely resonating. And the kinds of startup-related issues of finding the MRI, training the anesthesiologist, upgrading the system, the MRI to enable to use Tulsa. I think most of those things are now sort of such that we know how to resolve them compared to a year ago. And that is why I think we're seeing increased usage and that is what I think is driving the pipeline. I mean, in summary, Chris, I don't see any headwinds from the macro environment.

Awesome. Understood. Thanks. Thank you. One moment for our next question.

Our next question comes from Frank Tekening from Lake Street Capital Markets. Please go ahead.

Hey, this is Nelson Cox on the phone for Frank today. Thanks for taking the questions. So in prior quarters, you've talked about MR time being a challenge to come by and resulting in some backlog. Can you maybe update us on that dynamic in the most recent quarter and month?

Sure, Nelson. As I was saying in the other conversation, you know, we have enough different types of MRIs that we are compatible with. If we look at our install base today, I think we use all three magnets from all three companies, almost equal from all three companies, and that variety of MRs being used is continuing to expand. In terms of the usage time and availability, I think it's been, because we use a temporary code or cash pay mostly, basically what we've learned is once the patients are scheduled, the communication with the administration to make sure that the MR time is available, it works. It's more of a matter of how do we take an entirely new technology and make sure that the right things are discussed at the sites to drive utilization. I think that's what it is. The availability of the MR is really not the issue anymore.

Got it. And then one more quick one. In the past, you were talking about 60 a year kind of being the utilization rate. Can you talk about that trend with new users? Have you seen new sites ramping up? Or how have you seen new sites in the first three months, six months? And then what have you kind of seen for volume at that 12-month mark there?

Yeah, very good question. I, I do think that we are far better this year, as compared to last year. And in terms of the rent of the of the sites for several reasons. One of them is certainly we know a lot better, our sales team is more experienced and a lot better with respect to how to get the startup going, how to make sure we educate them properly and so on. Our clinical genius team is quite frankly great at it. And I think the second reason is the things that I talked about, the fact that now they can see the wide variety of patients. So they're no longer just saying, oh, gee, I'm going to treat only this type of patient with this technology. I think they're starting to see that they can treat more patients. And so I do think that the rate of startup, the rate of adoption will increase. And as I mentioned in the prepared remarks, I think the goal that we set in U.S. revenue of, you know, 70% growth this year is all related to that is what I think is likely to happen. And I also think, you know, our install base compared to, you know, six months ago is going to double by the end of this year. So I also think, you know, 2024 should be, you know, even better compared to this year. So hopefully that helps.

Yeah, thank you. Congrats on the quarter. It's good to see the progress.

Thank you, Nathan.

Thank you. As a reminder, if you would like to ask a question, please press star 1-1 and wait for your name to be announced.

One moment for our next question.

Our next question comes from Ben Hainor from Alliance Global Partners.

Please go ahead. Thanks for taking the questions, and congrats on the CPT code front.

Thanks, Ben.

You're welcome. Just wanted to hit on kind of a couple of big picture comments you made in the prepared remarks. You mentioned that being able to get to north of 75% gross margin with enough volume. You know, just kind of wondering where you're at on sort of a marginal gross margin basis, if you will, or contribution margin basis currently with the, you know, kind of the consumables.

Yeah, that's a great question. That's kind of where the confidence comes from. I think the marginal margins are, you know, already fairly close to that number. So, yeah, I think it's more about absorption of the overhead. In terms of technology, I don't think we have to do much, even though we have an excellent engineering team and they're driving the cost of goods also and quality. But I think that getting to that margin is really more about absorption over a larger volume.

So from a short term, the marginal contribution from the increased revenue is going to be in line with what we have been reporting in Q1, Q2. But over time, as the volume goes significantly higher, that's when we expect that the margin is going to improve north of 70% is because, again, number one is we're going to have a volume discount that we can negotiate with the vendors. And the other point that Owen mentioned is we can spread out our regular override with a lot more product. Okay, perfect.

Thanks for the call there, guys. And then, you know, just on the 50 installs this year and over 75 at the end of next year, you know, as one of the earlier folks pointed out that, you know, that's six-ish a quarter, which doesn't seem like it's that heavy a lift, right? Given that you now have the CPT codes behind you, I know that doesn't kick in right away, but it would seem to me that that would accelerate fairly easily or you could get to more than six to a quarter relatively readily. I mean, any commentary there?

Ben, I think on paper, everything looks great. But I think in reality, getting to where we are has been a lot of work. And it has not been because of our technology. It has not been because patients are not happy. Our patients are very happy. It has primarily been because this is such a unique technology and the workflow is so different. So I think... I feel far better today that we know how to tackle that workflow than I felt a year ago. But that's the reason I just want to be very open about this, is I feel we're definitely in the right track. We're growing at the pace that I think is appropriate for us, but I'm certainly not at a point where we're ready to talk about faster growth than what we have. Okay.

Fair enough. And then lastly, for me, you mentioned in response to one of the earlier questions that the engineering team is doing a great job. And I apologize if I missed this earlier, but anything new kind of on the R&D front or that we should be on the lookout coming soon or I know you had some stuff in the deck recently, but just curious on any updates there.

Yeah, Ben, again, great point. I think the most important one that is on the horizon is the Tulsa AI, which will not only use the knowledge of a few thousand cases that have been successfully done, and based upon that, it will automatically provide a guideline to the physician of where, you know, how to plan the treatment. And so I think that is, you know, of course there is more that I'm not going to share today, but certainly next year we will. But I think the point being that it will not just, it's not just a time saver. But I actually think that over time, it has the potential to improve outcomes beyond this threshold that about 20% of the patients always need something else beyond the first treatment. I think that is something, quite frankly, very exciting to us, and we will be monitoring how it goes. And we're working according to the guidelines that FDA has provided to us, and I feel very good about being able to deliver that product next year. And I do think that that product will provide some growth in 2024 as well. Okay.

Great. Appreciate the call there. And that's it for me. Congrats on the CPT prompt and the progress.

Thank you, Wynn.

Thank you. Our next question. One moment. Our next question comes from Joshua Jennings from TD Cowan. Please go ahead.

Hi. Good afternoon. I was hoping to just start off. and ask about, you know, as we look out into 2025 when reimbursement will be in place and some of these engineering development projects will be, the system will enhance the Tulsa Pro system. Wanted to also just ask about how you're thinking about the advancement of MR technologies and potentially some of the large imaging players evolving their systems to better integrate with the delivery of MR-guided interventions like a PULSE approach system.

Good afternoon, Josh. Yes, that's it. That's a very good conversation to have also. So we are in communication with the MR companies. And as you know, there is, there's a lot of innovation coming along in that space in itself. And I think that, as a general comment, I would say there is recognition by MR companies also that moving from the standard robotics to MRI-based, incision-free robotics is where the next growth could come from because I think if we go into the ASCs, this is one way that we can get to ASCs where they've always wanted an MRI. where we think we can be one of the key justifications to get one. And so I think the MR companies also are looking at interventional MRI as a growth opportunity for themselves. And they look at Tulsa and this, again, the flexibility and the variety of patients we can treat as potentially a very good driver towards that change. So I do think, Josh, that, uh, you will see more and more dialogue. Um, and I think it will come into the public domain, you know, in 2024 timeframe where you will start to see some, um, alignment, uh, with the MR companies and Tulsa.

That's exciting. And then you did mention ASC's Aruna was just, uh, Hope I didn't miss this, but just the potential for expansion of the C code for Tulsa Pro coverage in ASCs maybe next year and any updates there. And then also would love to just hear about if you can expand on the ASC opportunity and how that channel could evolve outside of just the evolution of MR systems and getting MRs into ASCs. Thanks for taking the questions.

Yeah, absolutely, Josh. So the ASC question I've answered, it's basically work in progress. The data that we have submitted to the CMS strongly supports the expansion, and we have a meeting coming up with them. You know, I think it's hard to predict exactly where they're going to go. And I was saying before, you know, the data, usually CMS does what data supports, but you never know. And so from that perspective, I'm optimistic. On the other hand, the code that we're using is a generic code, and so they might feel like they don't want to change the code. And the fact that we are getting the CPT code approved might actually be a bit of a pause for them because they might say, well, they're going to get it by 25 anyway, so why do I want to change this generic code for one year? So I could see arguments on both sides. but I do think that it's not a very big change for CMS to make, and so I do have some level of optimism that we could get there. But I think the bigger point that you're making is a very important one, which is that I think ASCs can be a prime target for us in the long haul to drive usage of this technology because, you know, you do those procedures at ASCs where you don't have the possibility of emergencies or emergency for the patient. And in our case, because there is no incision, and as I've talked about before, If the lights go out, they can basically wake up the patient, take the catheters out, and tell them to come back in two weeks. And in Europe, that has happened at least once that I know. And so it's not a risky procedure from that perspective. And so I do think that ASCs are going to gravitate uh towards this and mri companies will gravitate towards this and we think that's where this belongs as well so i think hospitals and asc's over the long haul are likely to be the the best places for this procedure and it's a day of procedure so i do think patients will be much happier going to those outpatient places appreciate all the answers thank you

I am showing no further questions at this time, so now I will turn the conference back over to Dr. Minowat for closing remarks.

Thank you so much, and we look forward to updating you at the Q3 call. Thank you.

This concludes today's conference call. Thank you for participating. You may now disconnect.