Operator: Thank you for standing by and welcome to the Profound Medical Fourth Quarter and Full Year 2024 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. [Operator Instructions] As a reminder, today’s program is being recorded. And now I’d like to introduce your host for today’s program, Stephen Kilmer, Investor Relations. Please go ahead, sir.

Stephen Kilmer: 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 Security 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 expressed or implied statements or guidance regarding current or financial performance and position, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment, and osteoid osteoma, and its future revenues, financial results. 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. Representing the company today are Dr. Arun Menawat, Profound’s Chief Executive Officer, Rashed Dewan, the Company’s Chief Financial Officer, Dr. Mathieu Burtnyk, Profound’s President, and Tom Tamberrino, our Chief Commercial Officer. With that said, I’ll now turn the call over to Rashed.

Rashed Dewan: Good afternoon, everyone, and welcome to our fourth 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 Mathieu in a moment to provide updates on TULSA utilization trends and the CAPTAIN clinical trials. However, before I do, I would like to provide a brief summary of our fourth quarter 2024 financial results. To streamline things, all of the numbers I will refer to have been rounded, so they are approximate. For the three-month period ended December 31, 2024, the company recorded revenue of $4.2 million, with $2.7 million from recurring revenue and $1.5 million from one-time sale of capital equipment.

Fourth quarter 2024 revenue increased 108% from $2 million from the same period in 2023. Gross margin in Q4 2024 was 71% compared to 52% in Q4 2023. As previously stated, gross margin will vary quarter-to-quarter due to product mix. Total operating expenses in the 2024 fourth quarter, which consists of R&D and SG&A expenses, were $11.3 million compared with $9.8 in fourth quarter 2023. Overall, the company recorded a fourth quarter 2024 net loss of $4.9 million or $0.20 per common share, a 45% improvement compared to a net loss of $8.9 million or $0.42 per common share for the same three-month period in 2023. As of December 31, 2024, Profound had cash of $54.9 million. So to summarize, this was really our best quarter overall so far. We delivered record revenue of $4.2 million, record gross margin of 71%, and lowest net loss since the first quarter of 2020.

We also ended the year with a strong balance sheet. With that, I will now turn the call over to Mathieu.

Mathieu Burtnyk: Thank you, Rashed. In the fourth quarter, there were 17 presentations featuring TULSA-PRO at major society meetings, including the Interventional MRI conference in Annapolis, Focal Plus in San Diego, the French Urology Congress in Paris, RSNA in Chicago, and the Society of Urological Oncology in Dallas. These clinical presentations focus on the precision and flexibility of TULSA as the only device that can safely deliver whole-brain ablation for diffuse or multifocal prostate disease and targeted ablation for discrete disease. Precision is a key word here because it is the MRI that gives physicians the precision they need to treat the types of patients they treat. MRI is the unparalleled precision to visualize the prostate.

MRI is the real-time precision achieved by closed-loop thermometry control. Meanwhile, precision is the 1.3 millimeter ablation accuracy proven on whole mouth histopathology from gold-standard clinical treatment surgical studies. Precision is the ability to treat to the outer edge of the prostate without injury or leaving cancer behind. This precision is important because the nerve bundles that control erectile function run right along the side of the prostate, all within two millimeters from the prostate surface. This precision is important because cancer grows right to the edges of the prostate. Together with precision, the flexibility of the Tulsa technology, how it was designed to treat any region and any size prostate, is what makes it uniquely positioned to become a mainstream treatment option for men with prostate disease.

With all of the other ablative prostate technologies, those on the market, those recently cleared by the FDA, or those that are coming down the pipeline, the fact of the matter is that they are all only well suited for single unifocal tumors and also only for very specific regions of the prostate. When we think about these devices, we can associate them with one of two categories. The first is one where they produce high temperature thermal tissue boiling, and the second category is non-thermal yet high pressure tissue destruction. With tissue boiling, there is so much energy being delivered in the tissue that it limits the actual volume of treatment achievable without starting to cause significant adverse effects. On the other hand, with high pressure tissue destruction, treating to the outer edge of the prostate, treating where cancer is typically located, risks perforating the capsule, which then also causes significant adverse effects.

TULSA is neither of these. TULSA is controlled and gentle heating, pixel by pixel, degree by degree. TULSA is precision heating all the way to the outer edge of the prostate, and even beyond, which is why we brought to market the Thermal Boost TULSA AI module in response to requests from our physicians. When you compare apples to apples, whole gland to whole gland, and focal to focal, TULSA wins every time, again, due to the precision of the technology and due to the flexibility of the ablation. To put some color to it, we know that HIFU and ablation can’t get to the interior of the prostate. So right off the bat, that’s 30% of cancer patients that don’t qualify. It is also well accepted that only 25% of patients have unifocal cancer suitable for focal therapy.

Then, considering the proportion of patients with disease right at the edge of the prostate, which we can conservatively estimate to be about 50% of the patients based on the real world usage of our Thermal Boost TULSA AI module, we can easily see that in at least two-thirds or more of the prostate cancer market, we are unique. If we evaluate on the following three axes, one, how much of the prostate volume you can ablate, two, what kind of prostate disease patients you can treat, and three, what range of prostate volumes you can treat, TULSA is the only technology, not just ablative, but of all prostate treatments that can effectively compete on these axes. This is based on the physics and science of TULSA, which translates to an opportunity that is unique to us with an addressable market that is real and substantial, which ultimately speaks to the robust adoptability of the technology.

Finally, as I’m sure you’re all wondering, we are delighted to remain on track with our CAPTAN randomized trial comparing the TULSA procedure to robotic radical prostatectomy. As of January 2025, 201 patients were randomized, and 174 patients were treated or scheduled for treatment. This represents the first randomized trial to have met its enrollment target, comparing a new technology to a standard of care treatment for localized prostate cancer. We are honored and looking forward to the first impactful readout from CAPTAN at this year’s AUA Annual Meeting in Las Vegas. I will now turn the call over to Tom to discuss where we stand with respect to planning and building our commercial organization to support growth.

Tom Tamberrino: Thank you, Mathieu. It’s a privilege to be here with all of you, and thank you for your continued interest in our company. I had the privilege of reconnecting with Arun over the summer of 2024. It had been some time since we last talked following the acquisition of NOVADAQ from Stryker, and Arun had allowed me to take extensive time and due diligence while looking at the opportunity to join Profound. I had the chance to meet with Mathieu, with Rashed, Board members, and many others, including investors and Wall Street analysts. The linchpin for me joining came when I attended the Pro Talk Live event that took place in Las Vegas in September of 2024, and I had the privilege to hear our patient, Robert Palmer, who had gotten TULSA-Pro and was so pleased with the results that he’s become an ambassador for the technology.

After hearing his journey through prostate cancer and his treatment with TULSA-PRO and the reasons why he would only recommend it to other men facing prostate cancer, I messaged Arun at that very moment to let him know that it would be my privilege and honor to join Profound. I started in mid-October, and in 120 days, I am proud to announce that we’ve done a complete turnaround of the commercial organization on a global scale. We have used no recruiters in our build-out of the team, and everyone is a known entity, whether that be from NOVADAQ or LifeCell Corporation. The folks that we’ve been able to bring on the team are constant professionals, and they are world-class in sales, in marketing, and also in business development. As you heard from Rashed, we delivered in the fourth quarter, and in the same breath, in parallel, we’ve been able to transition from what was a placement model to a capital model, also as noted within our results from Q4.

The individuals that joined us from Endomag were a team of five. They took that organization’s U.S. sales revenue from $8 million to $32 million in a five-year period. That organization was recently acquired by Hologic, and the list goes on of other well-known brand name entities within the medical device industry, whether that be Stryker, Intuitive Surgical, Imbuity, Axygen, et cetera. We have a world-class team. The organizational structure calls for a Vice President of sales here in the United States, Adam Milligan. Reporting to Adam are two Directors of Sales. Each Director of Sales has four regional business directors, and each regional business director has three capital sales executives. In parallel, as business need requires, we will layer in clinical sales specialists who will focus on the adoption and drive volume procedures at the centers established by our capital sales executives.

Our commercial strategy specific to the U.S. is prototypical of anyone in the cancer arena, which of course we are, which is to focus on the top 50 cancer centers, many of which are already adopters of TULSA-PRO, added to which regional and bread-and-butter hospitals will also be in our target. We’re agnostic to the diagnostics, and we have the privilege to partner with Siemens, Philips, GE, and other manufacturers in the MR space. We’re also approaching a B2B market, and we’re looking to go with entities that have established portfolios of the ambulatory surgical centers, as well as Lugpus. The beauty of being here at Profound is that when I compare it to my time at NOVADAQ with Arun, we had a sort of an empty chessboard in many ways. We didn’t have as many chess pieces as we’d like when going to battle with the likes of a Stryker, an Arthrex, or Storz.

But here at Profound, the chessboard is full. Everything is completely aligned. We have reimbursement as of January 1st through CMS. We have clinical data, as Mathieu just mentioned, not only already in our repertoire, but forthcoming. And we are developing a very robust and world-class health economics and market access team. Our deliverables for 2025 are to create awareness of TULSA-PRO, to create access to TULSA-PRO, to drive adoption of TULSA-PRO, and subsequently drive advocacy of TULSA-PRO at the physician level, at the patient level, and at the private payer level. In terms of our revenue growth, if you look at what we accomplished in 2024, I believe there’s a great foundation to build on the future. I also believe that we will achieve similar or better to what we did in 2024, so something in the 70th to 75th-ish percentage range in terms of growth.

And once 2026 comes around, barring any black swan events, we should be into the triple digital growth phase where we head up the shaft of the hockey stick. Once again, thank you for your time. It’s my privilege to turn the call over to Arun.

Arun Menawat : Thank you, Tom, and welcome to the company, and good afternoon, everyone. Overall, 2024 was a good year as we met or exceeded key operating goals, including revenue, margin, utilization per TULSA install device, introduction of TULSA AI modules, reimbursement, and recruitment in the CAPTAN trial. As you heard from Mathieu, our clinical story is crystal clear. TULSA’s precision, flexibility, and resulting TAM in prostate disease is unmatched by any competing technology. And TULSA’s economic proposition is now clear as well. Our urology APC Level 7 codes, which came into effect at the beginning of 2025, are not only paid at a higher level 7 than our peers who are all at level 6, but the codes are also applicable in an unrivaled range of treatment settings, including hospitals and ASCs, imaging centers, and office settings such as large urology practices.

So, a better procedure addressing a larger patient population reimbursed at a higher rate and also in more settings. To be frank, I think it’s great to be in 2025, where we can now finally talk about top-line growth. That’s why I asked Tom to join us today, and he will be on our calls going forward. As you heard from Tom, he is already recruiting to add to our team of sales professionals and is also bolstering the sales management organization to prepare for the growth that we expect going forward. We are also increasing our patient education programs to further build awareness of TULSA procedure among men and their caregivers. At the end of the day, it’s all about patients, and we already know from the feedback that we have received, when provided with information about their options, prostate disease patients pick TULSA every time as their first treatment of choice.

In the interest of time, I’m going to close out our prepared remarks here by summarizing the four key things we’re looking forward to delivering this year. One, we expect the perioperative data from CAPTAIN to become available at AUA in April. We plan to use the results of this trial to help support additional acceptance or reimbursement by private insurance companies and seek addition of the TULSA procedure as a treatment modality in cancer society guidelines. Two, we are on track to introduce the BPH TULSA AI module that will allow for customized treatment that is comparable in terms of speed to other modalities like Aqua ablation. We plan to demo the BPH module at AUA in April. Our BPH application will focus first on those patients who need a surgical intervention instead of drug intervention.

That segment of the market is approximately 400,000 patients per year, tripling the total opportunity for TULSA from about 200,000 cancer patients to a total of 600,000 prostate disease patients per year. Again, as a reminder, the TULSA AI BPH module will not require any hospital stay nor is there any post-treatment bleeding. Three, another major initiative for Profound this year is the introduction of TULSA Plus, which stands for selling both TULSA-PRO and the Siemens interventional MRI, FREMAX, as a combined total prostate solution. This solution streamlines the workflow and has the potential to be available in surgical suite of a hospital or an ASC or a urology clinic. We plan to launch in the second half of 2025. And finally, we expect high double-digit growth in 2025 with the proverbial hockey stick of rapid accelerated growth starting to form in late 2025, early 2026 with triple-digit revenue growth in 2026 and beyond.

As we anticipate another dynamic year, we are laying plans to host a hybrid investor meeting at the AUA to showcase the captain perioperative results, the new BPH AI module, and update investors further on the progress of the TULSA Plus program. We’ll provide the details as soon as they are available and hope you can join us either in person or virtually. This ends our prepared remarks for today. With that, we’re happy to take any questions you might have. Operator.

Operator: [Operator Instructions] And our first question comes from the line of Rick Wise from Stifel. Your question, please.

John Baugh: Hi, Arun and team. This is John for Rick tonight. Maybe starting off on the commercial side of things, both Arun and Tom, you highlighted very strong double-digit growth this year, 70% triple-digit in the following years. Just I hope you can talk about what you’ve seen in the first few months of this post-Medicare reimbursement environment that gives you the confidence to talk about such robust growth acceleration in the years ahead.

Arun Menawat: Sure, John. Good question. So, I think that from the perspective of the clinical value of product, as I’ve said before, we do not get much of a pushback. And that continues to be the case even more. From the perspective of the economics, we have put together pretty clear models that we can show to the hospitals that can be a more profitable procedure for them with the higher reimbursement that we get. And I think that even in Q4 in terms of what that means in terms of results, you can clearly see we had a pretty good quarter in terms of capital sales because we did switch to that model. And in Q1, we’ve already sold capital sales. And so, I guess that’s about as much color I think I can give you. The pipeline is pretty good. The sales team is energized. Tom, if you have any other comments, please feel free to mention it.

Tom Tamberrino: Absolutely. Thank you, Arun. John, thank you for the question. I think you nailed it right on the head, Arun, specific to the clinical sale is one thing. The financial modeling sale is another. And then the last component is the adoption sale after the technology has been acquired. And my estimation from discussions with users who were very much cash pay only is that they have received many inquiries from folks now that there is coverage that they had not been hearing from before, which is a wonderful thing that we’ve created additional access for more men to be able to afford the TULSA-PRO procedure. And as was mentioned in the prepared remarks, we are taking a firm stance and going after the private payers to ensure the same in terms of lives with positive payer policies so that even more men have an economical way to obtain access to TULSA-PRO.

And in the same breath, it provides a healthy economic model for not only the facility, but also for the physician. So, everybody wins. And I think those are the tailwinds that give us the confidence to make the statements we did specific to growth rates for this year and 2026 and beyond.

John Baugh: Great. That’s helpful. And just to build on something you mentioned in there, Tom, I just wanted to maybe get a better sense. Arun in the past had talked about reaching 75 sites by the end of 2025. And if you just had one, any update on that number, and two, in terms of, you guys talked about switching the model to capital sales. You were sort of doing a mix of capital and recurring in the past. Is it all capital now or is there still the recurring portion of the business in place as well?

Arun Menawat: So, yes, let me answer the first part and I’ll ask Tom to cover the second part. In terms of the install base, as we discussed in the Q3 call, we were not going to get to the 75 target last year. But as you can see from the recurring we did grow — we grew nicely. But we did switch to the capital plus recurring model. And that is where majority of our sales are at this point. And I think we will grow the install base again in Q4. The only reason we decided not to give you the specific number today of what the install base is or what, you know, resetting the target is because I do want to get a couple of quarters under our belt, particularly with this new model, so that we have some level of predictability. But, you know, I think by second half of this year, we will start putting those numbers out for you as well. With respect to, you know, the deals, Tom, maybe you could address the capital and recurring.

Tom Tamberrino: Absolutely. Yes. Thank you, Arun. And, John, thank you again for the question. I’m happy to do so. I’ve got a few different comments in response to that inquiry. Number one is Profound Capital Solutions enables customers to obtain ownership of our technology through any number of means, right? Number one, of course, is just a straight purchase order where it’s direct from the person taking ownership, entity taking ownership, and they’re going to pay that invoice and paying cash. As any other company would do, we offer solutions such as operating leases, capital leases, committed cost per procedure agreements, et cetera, to accelerate the adoption in lieu of capital budgeting cycles within your traditional hospital systems.

That’s one comment I’ll make there. And then I also want to make of the fact that the revenue streams that open up because of switching to the capital model is not only the capital infusion, of course, at the time of acquisition, not only the disposable revenue that comes from purchasing the kits that are required to complete each procedure, but, of course, the deferred revenue that will be building up over time specific to the service on those capital agreements, in addition to the fact that we will continue to advance the AI capabilities and the software capabilities associated with the technology, and that’ll be a fourth revenue stream that will provide further growth in the years to come.

John Baugh: Got it. Thanks.

Operator: [Operator Instructions] Our next question comes from the line of Michael Freeman from Raymond James. Your question, please.

Michael Freeman : Thank you. Hey, good evening, Arun, Rashed, Mathieu, Tom, and Steve. Congrats on a strong finish to the year, and thanks for these updates. My first question is around the launch and the demo of the BPH product. Nice to hear that you’re going to sort of reveal this thing at AUA. I’m wondering if, one, is there updated timing on the launch of that product, and are there any associated regulatory clearances for that module that need clearing before you can launch?

Arun Menawat: Sure. Mathieu, do you want to take that question?

Mathieu Burtnyk: Sure. Yes. Thank you, Michael, for the question. We are delighted to be in a position to be able to demo the BPH modules with a timeframe of AUA. I think we’ve been talking about a mid-year timeline for launch of the product, so it certainly falls in line with that. And again, these are a set of modules that incorporate AI as well as non-AI in order to streamline the procedure for total skin-to-skin time within an average of about 60 to 90 minutes. So, we do think that we’re on track for that. From a regulatory standpoint, I don’t know if I can comment specifically on that, but we have that as part of our project plan for the launch mid-year as discussed.

Michael Freeman: Okay. All right. Great. Thank you very much for that. I have another question here. I wonder, now that you’re much of the way through your first quarter, you mentioned that you have had some more placements. I wonder if we could just talk about utilization and talk about uptake among Medicare payers. You mentioned that there was an uptick in inquiries that you’re hearing from the doctors in your network. I wonder if you have seen an uptick in actual payments through Medicare in your first quarter.

Arun Menawat: Oh, the actual payments? Michael, payments typically take — Medicare takes a long time to pay. So, I don’t have good data on the actual payment. I don’t see any issue with it at all, but I don’t think we have a lot of data on the payments itself. I think based upon the Q4 recurring revenue, you’ll see the numbers are certainly up. And I think the trend is, as Tom described, are up as well. We are getting sporadic, very early stage data also that in certain centers, some of the bigger private insurance companies are paying. And in some cases, they’re paying after preauthorization. In some cases, they do provide a number to the patient after the procedure and they are paying. And from what we hear, the sites are happy with what they’re getting. We obviously don’t know what the exact numbers are, but I think we generally are hearing satisfied users from that perspective.

Michael Freeman: Okay, that’s great. And just a quick follow-up to that. With some of the larger private insurance companies providing payments, either with or without pre-op, these seem like obvious targets for first conversations, even without the caps and data. Do you have, I guess, reimbursement personnel pursuing these specific companies as first targets?

Arun Menawat: Yes. So, Michael, as I’ve talked about this before, that given that ablative therapies are becoming more prevalent and insurance companies have been paying, I think that our job in terms of getting payments is not as insurmountable as if we were the first ablative therapy out there. So, I do think that this is work in progress. It’s going to happen. CAPTAIN trial results will definitely help significantly. But to answer your direct question, we are — in Tom’s team, we are adding a team that is going to explicitly come up and develop a strategy of which insurance companies to go after first and prioritize them. And ultimately, we will get there to all the major players. How we make that priority decision, Will, you’re right in the sense that some of it will be based upon which companies are already paying and how many centers, what has been the dialogue.

It will also depend on certain regions where we have a bigger install base. So, it will have an impact. So, there are a number of different things that we will look at and which companies we go after first. But I think in general, the theme of what you’re discussing is right on our strategy that we have specialized people who are going to be working on this. And we don’t expect major issues. The timing is going to be whatever standard timings are for these things, but we don’t expect that to be a major issue.

Michael Freeman: Okay. Thank you very much. I’ll pass it on now.

Operator: Thank you. And this does conclude the question and answer session of today’s program. I’d like to hand the program back to Dr. Menawat for any further remarks.

Arun Menawat: Thank you so much. And we are looking forward to not just Q1, but also hopefully everyone joining us as we provide more details for the virtual or hybrid conference that we will have at the AUA in April this year. Thank you.

Operator: Thank you, ladies and gentlemen, for your participation in today’s conference. This does conclude the program. You may now disconnect. Good day.

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