Profound Medical Corp.

Good day, and thank you for standing by. Welcome to the Profound Medical first quarter 2024 financial results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand has been raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker, Stephen Kilmer, Investor Relations.

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, including the company's year 2024 financial guidance and related assumptions, the expectations regarding the efficacy of Profound's technology in the treatment of prostate cancer, PPH, uterine fibroids, palliative pain treatment, and osteoids, osteoma. and its future revenues financial results. Such statements involve known and unknown risks and uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Profound undertakes no obligation to publicly update or revise any forward-looking statement whether as a result of new information, future events, or otherwise, other than as required by law. Representing the company today are Dr. Arun Manawat, Profound's Chief Executive Officer, Rashed Duwan, the company's Chief Financial Officer, and Dr. Matthew Burtnick, Profound's Chief Operating Officer. With that said, I'll now turn the call over to Rashed.

Good afternoon, everyone, and welcome to our first quarter 2024 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 updates on Tulsa clinical publications, utilization trends, and the CAPTAN clinical trial. However, before I do, I would like to provide a brief summary of our first quarter 2024 financial results and our revenue guidance for the year. To streamline things, all of the numbers I'll refer to have been rounded, so they are approximate. For the three-month period ended March 31, 2024, the company recorded revenue of $1.91 million, with $1.48 million from recurring revenue. and $428,000 from one-time sale of capital equipment. First quarter 2024 revenues increased 3% from $1.86 million from the same period in 2023. Actual usage during the quarter grew at double digits, but there was a reduction in cost of consumables inventory at some install sites. While we anticipate that user inventory levels will continue to vary throughout the year. We still expect recurring revenue will grow at 60% or more. Gross margin in Q1 2024 was 66% compared to 65% in Q1 2023 and up 53% sequentially from the previous fourth quarter. Similar to recurring revenue, we expect gross margin to vary some quarter over quarter, but just as we delivered about 60% margin in 2023, we expect to deliver that or better in 2024. Total operating expenses in 2024 first quarter, which consists of R&D, G&A, and selling and distribution expenses were $8.8 million, an increase of 9% compared with $8.1 million in the first quarter of 2022. Breaking that down further, expenditures for R&D increased 2% on a year-over-year basis to $3.9 million. G&A expenses increased by 13% to $2.4 million and selling and distribution expenses increased by 15% to $2.4 million. Net finance income for the 2024 first quarter was $1.3 million, compared to $145,000 for the same three-month period of 2023. Overall, the company recorded a first-quarter 2024 net loss of $6.2 million, or $0.26 per common share, down from a net loss of $6.7 million, or $0.32 per common share, in the same three-month period in 2023. As of March 31, 2024, Profound had cash of $41.2 million. Finally, as you may have seen in our press release, We are providing annual revenue guidance for the first time as we believe we now have sufficient visibility into the pace of Tulsa adoption ahead of the start of reimbursement in January. Based on our business planning and budgeting activities, we currently expect total revenue for the full year 2024 to be in the range of $11 million to $12 million, which represents 53% to 67% growth compared to revenue in 2023. With that, I will now turn the call over to Matthew.

Thank you, Rashed, and hello, everyone. Since the start of the year, there have been many conference presentations featuring Tulsa that continue to demonstrate the unique pixel-by-pixel precision of the technology, the flexibility to treat a variety of patients with customized treatment plans, as well as the durability of efficacy and safety treatment outcomes. As announced earlier this week, 25 Tulsa related scientific research presentations have been delivered at major international medical meetings so far in 2024, of which eight were from leading urologists at the recent American Urological Association meeting in San Antonio, Texas. I would like to take a few minutes to highlight a couple of these. The first is a presentation by Dr. Ethan Wajwal from the Mayo Clinic Florida on their initial experience with the Tulsa Pro in men with localized prostate cancer. They reported oncologic and safety outcomes from 60 patients, including 47% whole gland, 33% subtotal, and 21% focal ablation. With a PSA reduction of 92% to a nadir of 0.5 nanograms per milliliter, and a 4% rate of clinically significant histological failure on one-year follow-up biopsies, the authors conclude that their early post-market experience treating grade group 2 and 3 prostate cancer with focal through whole-gland ablation plans demonstrates comparable safety and efficacy to that reported in the TACT FDA registration study. The second is a presentation by Professor Peter Bostrom, Chair of the Department of Urology at Turku University Hospital in Finland, Patrick DePauw, who reported the complete 12 month outcomes of the prospective single Center phase one slash to study of Tulsa and men would be pH. Patrick DePauw, The treatment plan targeted the entire transition zone, including median little bit present in 30 men, the prior measure of treatment efficacy, the IPS that score improved significantly from 16.5 to four. Of note, the 75% reduction in IPSS is similar or better than that reported in the pivotal FDA studies of all modern minimally invasive BPH devices. Additionally, the quality of life index, called EPIC, improved in both the sexual and urinary incontinence domains from 54 to 67 and from 85 to 100, respectively, possibly related to the reduced prostate volume and pressure on surrounding nerves. With the completion of this Phase 1-2 prospective clinical study, the Tulsa Pro is the only incision-free device with safe and effective clinical evidence in patients with primary prostate cancer, radiorecurrent disease, and now also BPH. The growing body of clinical evidence demonstrating the ability of the Tulsa procedure to treat patients with an unrivaled variety of prostate disease is reflected in real-world utilization trends from Tulsa providers in this quarter, as highlighted in today's press release. With respect to indications, approximately 71% were treated for primary prostate cancer, 21% were hybrid patients suffering from both cancer and BPH, 6% were salvage treatments, and 2% were men with BPH only. TULSA procedures were performed across a spectrum of treatment plans with approximately half or 53% whole gland, 26% subtotal but more than half the gland, 10% hemiablation, and 12% focal therapy. This continuum of treatment plans matches what we could expect from the general prevalence of prostate cancer, whether diffuse or bilateral disease, multifocal cancer, and a smaller proportion of unifocal prostate tumors. Prostate cancer patients across all grades of disease were treated, primarily intermediate risk patients with 74% being grade group two and three, 15% low risk grade group one, and 13% high-risk grade group 4 or 5 cancer. Similarly, patients with all prostate shapes and sizes continue to be treated with Tulsa from less than 20cc to over 100cc. This quarter, about one-third had prostate volumes under 40cc, another 40% had prostate volumes between 40 and 60cc, and the remaining 27% had larger prostates over 60cc. We continue to see TULSA as the only treatment modality which can be used across the entire spectrum of prostate volumes and disease with clinical evidence in patients with cancer or BPH, as well as the only option for hybrid patients who have both prostate cancer and BPH. Now, I will turn the call over to Irene.

Thank you, Matthew. And good afternoon, everyone. As you can see from what Matthew just reviewed, our message is clear. Regardless of prostate disease state or prostate size, TELSA is being used to treat a wide variety of patients safely, effectively, and efficiently. In fact, no other modality even has the clinical publications that demonstrate applicability in such a full spectrum of patient population, ranging from BPH to any stage of organ-confined prostate cancer to even salvage cases. In addition, TELSA is incision and radiation-free, one-in-one procedure performed in a single session. No hospital stay is required, and most Tulsa patients report quick recovery to their normal routine. The Tulsa procedure is done with real-time imaging in the MR board, which allows for phenomenal pixel-by-pixel accuracy and real-time temperature measurement and automated control. The use of MR is now growing in urology as clinical evidence continues to point to the benefits of MR imaging from early patient screening to diagnosing and treating with TELSA. We believe that MR will continue to gain acceptance in urology. Indeed, there are growing signs that MR is poised to become a mainstream imaging modality for urology. Here are just a couple of data points. AUA has been holding education programs to teach reading MR images at the annual conference every year for the last four years. This year, the course was fully booked with a waiting list Urologists are getting the message that they need to learn to read MR imaging. And as of this year, AUA is requiring that all residents be educated on learning how to read biparametric MRI as part of their residency training. Tomorrow's urologist will be comfortable with MR imaging and Tulsa is purposefully MR centric. It looks like the world is now moving in the direction of where we are. Accordingly, we have started to forge even closer relationships with the three major MR companies to go beyond compatibility of our respective technologies and to help maximize the tremendous opportunity that we see ahead for both us and them. Recognizing the increasing use of MR in urology, manufacturers are looking to develop interventional MRs that can fulfill that growing need. a few of the leading teaching hospitals have already expressed a desire to install interventional MRs. In February, we announced a collaboration with Siemens Healthineers to work towards bringing a complete therapeutics solution to urology by combining our TELSA Pro system with their newly announced interventional mr solution the magnetron premax mr scanner this arrangement is non-exclusive and we will also continue to market Tulsa Pro as a standalone offering providing our customers with the flexibility to leverage the use of existing mrs or acquire an entirely new system with EMR hardware of their choice. The aim of the collaboration with Siemens Healthineers is to create and market a total solution capable of providing images from patient screening to diagnostics and then TELSA treatment with a streamlined and efficient workflow at an optimized cost of care. This complete solution can also be used in additional outpatient settings, such as urology clinics, ASCs, and hospital physical departments that may not have previously been suitable sites. We look to be able to announce additional collaborations in the future. Moving on to the execution of our U.S. reimbursement strategy for TELSA, there isn't much to update you on since our last call. As you know, the American Medical Association established three PTT Category 1 codes for TELSA in mid-2023. As part of the process, the Relative Value Unit Scale Update Committee sent questionnaires to TELSA users to determine the physician work-related value units associated with the TELSA procedure. Based on the user feedback, the Center for Medicare and Medicaid Services is working with the societies that sponsored the CPT Category 1 code application to determine the TELSAP procedure payment amount that will be attached to the permanent codes. The proposed recommendations are expected to be published in the Federal Register at the end of July, finalized in November, and come into effect as of January 2025. Finally, I would like to reiterate our continuing commitment to innovation with the overall goal of increasing treatment efficacy, improving workflow efficacy, and expanding technology access to deliver an even better TELSA treatment experience for urologists and their patients. On that front, our submitted application for the second TELSA AI module called Contouring Assistant to the FDA is under review. This TELSA AI module uses past treatment designs and recommends a design in a new procedure based upon that knowledge. We believe that the contouring assistant will not only increase urologists' confidence in their treatment designs, but will also increase their procedural efficiency. In addition, we have begun development work on the next planned module, Tulsa BPH. More details on that will be provided later this year. To summarize, there is a large and growing body of evidence from clinical trials as well as from commercially treated patients that TELPHA is on its way to becoming a mainstream treatment modality across the entire prostate disease spectrum. We hope to receive FDA 510 clearance of the contouring assistant TELSA AI module in the coming days and weeks. We also eagerly await a CMS decision regarding the TELSA proposed reimbursement rate at the end of July. We are excited by the increasing use of MR in the care continuum of prostate disease management, and we continue to work with Siemens and the other two leading MR manufacturers, Philips and GE, to further support this modern treatment pathway. And finally, we now have sufficient visibility into the pace of TELSA adoption, both in terms of existing system utilization and install-based growth to initiate full year revenue guidance. That guidance is 11 to 12 million revenue for 2024. This ends our prepared remarks for today. With that, we're happy to take any questions you might have. Operator.

Thank you. At this time, we will conduct our question and answer session. As a reminder, to ask a question, you'll need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we create our Q&A roster. Our first question will come from Rick Wise with Stifel. Go ahead, Rick.

Hi, Arun, the rest of the team. This is John on Rick today. I just wanted to maybe start off on guidance and kind of how to read through performance this quarter to the rest of the year. So if I'm just sort of looking at the recurring base, it grew roughly 1% year over year. And the guidance sort of implies, and as you talked about, 60% plus recurring revenue growth implies a pretty steep ramp for the second half. So I just hope you could talk a little more about the key drivers there and your visibility to seeing that strong 2H growth.

Well, you know, it's not as steep a ramp as the numbers imply. We placed a number of new systems in Q4 last year and Q1 this year. And so those systems are, you know, they purchased the recurring revenue module kits in Q4, and we didn't want to put more until they use all of these up. And so it's more about, I think, as Rochette said before, It's about leveling and making sure there's not too much inventory of customer sites. But the number of sites has increased, and these sites have come up on speed now. So I think, as we've talked about before, quarter of quarter, we still have some variability, things like that. But for the year, we are very confident in terms of increasing the utilization and thereby the revenue associated with it. So, again, I would chalk this up to quarter-by-quarter variability, but we don't see it as a steep hill.

Thanks. That's helpful. Maybe just another question here. I remember on the last earnings call, you discussed potential changes to the business model in the sense that you might actually sell the capital versus sort of using this recurring structure. Just sort of a few months later, I just wanted to get your updated thoughts. How are you thinking about the profound business model today? Have you learned anything in the past few months or have your recent negotiations changed? conversations with CMS influenced your, your thoughts on what the profound business model is going to be going forward.

Yes, that's a great question also. And I think, again, part of the reason why we felt comfortable providing guidance is because I think we do have a lot more visibility at this point than we did last year. And I think to your question, we do think that we have a fairly good idea of what the business model is going to be. I think that we will go to a bit of a hybrid model. That is not to say that we will not place systems only on recurring revenue basis, but I think what you will see is that probably there will be a bit of a 70-30 mix where the recurring revenues are probably going to be in the range of about 70% and 30% revenues will come from capital revenues, capital side of the equation. But primarily, we will remain a recurring revenue company. So for new sites, they will have a choice. They can pay us full amount and use it on a per-use basis. And then what we will also see is that sites who will start with recurring revenue will start to maybe acquire based upon usage, and they convert it into a capital, and we're comfortable with that also. And so I think in overall terms, We think we will remain primarily a recurring revenue company. And we also are pretty comfortable that as the volumes increase, our gross margins will also continue to increase. And we think we are tracked to deliver better than 70% margin over time. As we go to this hybrid model, You know, we may reduce the recurring renew per patient price from, let's say, around $8,000 to maybe $7,000. We don't expect that to go down significantly. And then capital revenues are also high margin revenues. That answers all of your questions in sufficient detail.

Yeah, thanks. That was really helpful.

Thank you. One moment for our next question. Our next question is from Raul with Raymond James. Go ahead.

Thank you, operator. Good afternoon, Arun and Rashad. Thanks so much for taking our questions. So I just wanted to follow on from John's last question around the recurring revenue versus capital in the 70-30. I assume that irrespective of whether a customer is capital equipment versus recurring revenue, you're setting pricing such that the lifetime value per user is effectively equivalent. Are you able to sort of comment a little bit on that?

Yeah, I think that that is certainly the principle that we're using. And I think as you heard from Matthew's comments, also, we think that Tulsa is a very efficient procedure and that efficiency will continue to grow. And so we think that on use per unit time basis, we will continue to show productivity And that could, over time, be a reason to maintain our prices and maybe improve upon those. But you're right. In general, the principle really is that we will convert to a model that will be more suitable to the hospitals as the reimbursement comes in. And at the same time, we want to be sure that we get the value that we provide in terms of the efficiency of our product.

Thanks, everyone. That's very helpful. So, now, you'd indicated that there's a lot new on the reimbursement, and so I won't push on that. However, I wonder if you could perhaps orient us in terms of how, you know, CMS should be looking at pricing, given that surgery lands around $17,000, your interim code is currently around 13,000. There's significant benefit to TELSA given the, you know, essentially long-term to patients not having to go through surgery. So again, without prognosticating on where, you know, what number you will land at, are you able to sort of orient us in terms of how CMS will be driving towards a pinpointed number?

I'm happy to, Ravi. So, I think there are a number of things that are already visible. And one of them is clearly we are a prostate cancer treatment, and I think that we would be classified into a category close to where radical prostate myelobacteria. And because the cost numbers are sort of in line with that, given that we have been highly disciplined about making sure that we charge the patients correctly on the same amount and there are no hidden discounts and so on, I think CMS was quite appreciative of the fact that we ran a very clean market entry strategy. Another thing that is already clear is that the work that the committee have done in the in public domain, if you look into the public documents, and then we are codes are zero day global. At this point, there's always a chance that CMS could change that because until they publish there is no guarantee. But at the moment, they are slated to be the way the reckoning works was based upon the world. And that's an important point, because it's a procedure that's a daytime procedure. So the physician gets paid only for the day of the procedure. What that means is that they will treat pre procedure and post-procedure visits of the patients will be paid separately as compared to robotic prostatectomy or other procedures within prostate cancer that are paid on a 90-day global basis, which means that for the first nine days after procedure, the follow-ups are included. So I think what our expectation is putting all things together, apples to apples, that we will have a financial model that will be quite viable for the hospital. Is that helpful?

That's very helpful. Thank you very much, Aaron. And one last quick question. I know, Matthew, you talked about the recent clinical data. You've indicated in your press release that recruitment as a cabin trial is on track to be completed at the end of this year. So are you still looking at potential interim data at some point? When should we be oriented as to when we could potentially expect some data on the captain trial? And that'll be it for me today. Thank you.

Sure. Yeah. As we've said before, we're on track to produce interim data in the first half of next year. As soon as You know, because this is a level one randomized study, we cannot publish anything because of biases until all patients are treated. And we may have to wait 90 days for them, for that early results to come in. But we do think that in the first half of next year, as we've talked about before, we will be able to produce interim results.

Thanks very much. I'll get back to you.

Thank you.

Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone. Please stand by while we compile our Q&A roster. I am showing no further questions at this time. I would now like to turn it back to Dr. Minowat. Go ahead, doctor.

Thank you so much. Look forward to updating you at the next quarter and hopefully with some good regarding the CMS. Thank you.

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