Profound Medical Corp (PROF) 2023 Q2 法說會逐字稿

Good day and thank you for standing by. Welcome to the Profound Medical second-quarter 2023 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to Stephen Kilmer, Investor Relations. Please go ahead.

Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws in the United States and Canada. All forward-looking statements are based on Profound's current beliefs, assumptions, and expectations, and relate to, among other things, the 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, 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 develops and markets customizable incision-free therapies for the ablation of diseased tissue. We are currently commercializing TULSA-PRO, 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 510(K)-cleared by the FDA. In the US, 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 extended warranties.

Outside of the United States, we primarily deploy a capital and consumable sales and service model separately as the situation warrants that. We are also commercializing Sonalleve, an innovative therapeutic platform that is CE-marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases.

Sonalleve 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 Sonalleve's systems -- it's 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 Dewan, who is the Chief Financial Officer. With that said, I'll now turn the call over to Rashed.

Good afternoon, everyone, and welcome to our second 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 second quarter 2023 financial results. To streamline things, all of the numbers will 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&A expenses decreased by 21% to $2.1 million and selling and distribution expenses decreased by 6% to $2.3 million.

Net finance costs for the 2023 second quarter were at $884,000 compared with net finance income of $1.9 million in that same three-month period of 2022. Overall, the company recorded in 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 Arun.

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 TULSA 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 TULSA procedures in the United States would tick up to about 5% per month in 2023. By framing it at 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 US business will continue to grow at a similar or better pace in the second half of this year, delivering US revenue growth of about 7% 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 1 CPT codes, specifically for the TULSA procedure. And as you already know, that goal was achieved in June. With sponsorship and support from multiple physician specialty societies, the AMA established three new Category 1 codes for TULSA, 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 Update Committee or RUC, sending questionnaires to TULSA users to determine the physicians' work-related value units or RVUs associated with the TULSA 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 TULSA procedure payment amount.

For reference, the US hospitals performing the TULSA 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 installed base. Given that our US business model is about getting paid on a per patient basis, a larger installed base in preparation of January 1025 when the Category 1 CPT code will become effective will be important to drive faster growth in the future. Today, we have an installed base of 38 systems and additional seven contracts to be installed and a pipeline in the final stages of 15 additional installations. Altogether, this gives us confidence that we will meet the expected installed base of 50 systems by end of this year.

Indeed, none of the US business objectives or deliverables for the remainder of 2023 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 markets. Having said that, we do expect that our installed 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 a 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 salvage and 2% for men with BPH only.

TULSA 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 TULSA as the only minimally invasive option for such patients.

For cancel grade, approximately 14% were Grade Group 1, 60% was 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 therapy. For prostate size, approximately 4% were less than 20 cc, 34% were between 20 to 40 cc, 37% were between 40 to 60cc, 20% were between 60 to 100 cc, and 5% were over 100 cc.

Based upon these results, clearly, TULSA continues to be used in a wide variety of patients with prostate disease. And we continue to believe that the total addressable market for TULSA 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 TULSA 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 letter 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 CaPSURE registry, one of the largest databases of prostate cancers in the United States. Although this outcome was achieved despite the fact that a second TULSA ablation was not permitted by protocol. Since the early days of TACT, physician experience and protocols for patient selections and treatment have been refined. And on review, the risk of failure was mitigated by modern management approaches.

Additionally, we have been able to demonstrate that data from intraprocedural thermal MRI imaging and early clinical follow-up can indeed predict the risk of salvage therapy by five years. The five-year outcomes in the TACT 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 pad-free before TULSA remains 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 3 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 grade 3 severe or serious adverse events reported from two to five years.

To summarize most of the boxes for increased adoption of TULSA-PRO have now been checked. Our reporting of preliminary five-year results from the TACT 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 test data demonstrates that one year's 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 one CAPTAIN clinical trial.

TULSA continues to be unrivaled in the types and numbers of prostate disease patient that urologists are using to treat prostate disease safely and effectively. With 38 TULSA-PRO sites comprised of top-tier hospitals, independent corporate centers, and opinion-leading practices, we now have a large number of experience physicians, especially neurologists, who are ready to lead adoption of TULSA-PRO. We remain on track to grow our installed base to 50 TULSA-PRO sites by the end of 2023 and at least 75 by the end of 2024.

TULSA-PRO 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 growing forward. Our recurring revenue model already yield high gross margins of around 65%, and we think they will potentially exceed 75% in future with increased volume. We are delighted with the AMA's 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 CAPTAIN clinical trial will serve as a significant catalyst for TULSA adoption in the US beginning in the first quarter of 2025.

This ends our prepared remarks for today. With that, Rashed and I are happy to take any questions you might have. Operator?

Thank you. We will now conduct the question-and-answer session. (Operator Instructions)

Rahul Sarugaser, Raymond James.

Good afternoon, Arun. Good afternoon, Rashed. Thank you so much for taking our questions. And let me start by saying congratulations on getting the CPT codes this quarter. So my question is, it's nice to see the growth from 34 to 38 devices this quarter.

And so, 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 still 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, Rahul. Yes, I think we -- 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 about the 15 systems that are in the final stages or the seven contracts that we additionally have, that I would say -- of course, work that was done prior to that news. But yeah, I think the answer to your question -- 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. My second question is focusing on reimbursement. There was some discussion last time about potential expansion of the existing C code, 9734 to ambulatory centers. Would you be able to perhaps share an update on that?

Sure. Rahul, 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 we are in dialogue -- we're continuing to be in dialogue with CMS. It's kind of hard to put the odds at the moment. It could be that, hey, they're saying, well, a year from now, you 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.

Terrific. Thanks very much. And if you don't -- indulge in one last quick question. It's interesting to see the broadening use of right through active sales, BPH through salvage and of course, the range and size of the prostates that are being treated.

So now -- so translating this to the CAPTAIN trial and of course, your recruitment, how do you see your 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've outlined today and as you hopefully will continue to do as sort of leading indicators leading into that CAPTAIN readout?

Yeah. Rahul, that's a great question, actually. First of all, we are really, really focused on the US business at this point and so, the growth rates that I've talked about are US growth rates. And as the experience of the US community is increasing, I explicitly think you're right at 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.

But the 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 population.

But the CAPTAIN trial itself is actually more of a head-to-head against radical prostatectomy. So, the patient selection criteria there is similar to a normal prostate cancer patient who would be treated. And finally, you're right, we will -- we do expect that we will have the results -- the preliminary results, in early 2025.

And 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 the data was predictable in TACT. There's no reason why that should not be same. So even the early results should be impactful.

That's an important distinction. Thank you very much, Arun. And thank you again for taking our question. We'll get back in the queue.

Thank you, Rahul.

Thank you. (Operator Instructions) Michael Sarcone, Jefferies.

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 macroenvironment and the backdrop for system installs. Any challenges or bright spots to call out there?

Chris, good afternoon. I mean, I don't know if I have too much of a commentary. I think the pipeline is pretty strong. I don't think the macroenvironment 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 start-up 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. So, I mean, in summary, Chris, I don't see any headwinds from the macroenvironment.

Awesome. Understood. Thanks.

Thank you. (Operator Instructions) Frank Takkinen from Lake Street Capital Markets.

Hey, this is Nelson Cox on the phone for Frank today. Thanks for taking the questions. So, in prior quarters, you've talked about MRI 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 months?

Sure, Nelson. As I was saying in the other conversation, we have enough -- different types of MRIs that we are compatible with. If we look at our installed 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 hum.

And 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 MRI time is available, it works. So 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.

Sure.

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 for that 12-month mark there?

Yeah. Very good question, Nelson. I do think that we are far better this year as compared to last year in terms of the ramp of the sites for several reasons. One of them is certainly we know a lot better. Our sales team is more experienced and lot better with respect to how to get the startup going, how to make sure we educate them properly and so on. Like 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 -- they're saying oh, gee, I'm going to treat only this type of operation 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've set, US revenue of 70% growth this year is all related to that is what I think is likely to happen. And I also think our installed base compared to six months ago is going to double by end of this year. So, I also think 2024 should be 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, Nelson.

Thank you. (Operator Instructions)

Ben Haynor, Alliance Global Partners.

(technical difficulty) thanks for taking the questions, and congrats on the CPT code front.

Thank you, Ben.

You're welcome. Just wanted to hit on 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. Just wondering where you're at on sort of a marginal gross margin basis, if you will, or a contribution margin basis currently with the consumables?

Yeah. That's a great question. That's kind of where the confidence comes from. I think the marginal margins are already fairly close to that number.

Okay.

So yeah, I think it's more about absorption of the overhead. There's -- 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 it's getting to that margin is really more about absorption over a larger volume.

(multiple speakers) 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, the volume grows significantly higher. That's when we expect that the margin's 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 Arun mentioned is we can spread out our regular overhead with a lot more product.

Okay, perfect. Thanks for the color there, guys. And then just on the 50 installs this year and over 70, 75 at the end of next year, as one of the earlier folks pointed out, that's six-ish a quarter, which doesn't seem like it's that heavy lift, given that you now have the CPT codes behind you. I know it doesn't kick in right away, but it seemed to me like that would accelerate fairly easily or you could get to more than six a quarter relatively readily. 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 on 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. That's fair enough. And then lastly, for me, you mentioned in response to one of the earlier questions on -- that the engineering team is doing a great job -- and I apologize if I missed this earlier. But anything new 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 update 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 the few thousand cases that have been done -- that have been successfully done. And based upon that, it will automatically provide a guideline to the physician of where -- how to plan the treatment. And so, I think that is -- 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 timesaver, but I actually think that over time it has the potential to improve outcomes beyond the threshold of -- you know 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 are 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. I appreciate the color there. And that's it for me. Congrats on the CPT front and the progress.

Thank you, Ben.

Thank you. Joshua Jennings, TD Cowen.

Hi, good afternoon. I was hoping to just start off and ask about -- 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 -- I wanted to also just ask about how you're thinking about the advancement of MR technologies and potentially some large imaging players evolving their systems to better integrate with the delivery of MR-guided interventions like TULSA-PRO system.

Good afternoon, Josh. Yes, that's a very good conversation to have also. So we are in communication with the MR companies. And as you know, there is 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 ASC, 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 you will see more and more dialogue, and I think it will come into the public domain in 2024 timeframe, where you will start to see some alignment with the MR companies and TULSA.

That's exciting. And then, you did mention ASCs are -- was just -- 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 -- And 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. And I think it's hard to predict exactly where they're going to go. And I was saying before, the data usually CMS does what data supports, but you never know. And so on that -- 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 is approved might actually be a bit of a pause for them because they might say, well, they're going to get it by 2025 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 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 very -- a prime target for us in the long haul to drive usage of this technology because 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 ones 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 towards this and MR companies will gravitate towards this. And we think that's where this belongs as well. So I think hospitals and ASCs over the long haul are likely to be the best places for this procedure, and it's a day 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 turn the conference back over to Dr. Menawat 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.