Good day, and thank you for standing by. Welcome to the Profound Medical First Quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Stephen Kilmer, Head of 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, any expressed or implied statements regarding future financial performance and position and expectations regarding the efficacy of ProFound's technologies in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma. 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 Doctor. 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.

Good afternoon, everyone, and welcome to our first quarter 2025 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, the CAPTAIN clinical trial and our upcoming TULSA AI module for BPH. However, before I do, I would like to provide a brief summary of our first quarter 2025 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 March 31, 2025, the company recorded revenue of $2.6 million with $1.8 million from recurring revenue and $820,000 from onetime sale of capital equipment. First quarter 2025 revenue increased 82% from $1.4 million from the same period in 2024. Gross margin in Q1 2025 was 71% compared to 60% in Q1 2024. Total operating expenses in the 2025 first quarter, which consists of R&D and SG&A expenses, $13 million compared with $8.7 million in the first quarter of 2024. Overall, the company recorded a first quarter 2025 net loss of $10.7 million or $0.36 per common share compared to a net loss of $6.6 million or $0.27 per common share for the same three month period in 2024. As of March 31, 2025, ProFound had cash of $46.4 million. With that, I will now turn the call over to Mathieu.

Thank you, Rashed. The first quarter, the TULSA-PRO had a strong presence at several relevant medical meetings. More recently, just last week in fact, TULSA was featured in multiple presentations at the Annual American Urological Association Meeting in Las Vegas. One major catalyst at AUA was the initial data readout from the CAPTAIN trial, the first successful randomized controlled trial comparing a new technology to robotic radical prostatectomy. We were honored to hold this distinction would like to recognize the diligent efforts from all of the talented study surgeons who helped make this happen. One of the reasons we believe CAPTAIN was successful is TULSA's proven five year cancer outcomes in whole gland ablation. We are taking care of the whole patient. In addition to side effects, the patient's cancer is front and center as the primary outcome. CAPTAIN enlisted the nation's best academic and high volume private surgeons, which was critical for successful randomization. If we can show statistical significance in CAPTAIN, the real world improvements will be that much more impactful. Now to the data. TULSA completely eliminates blood loss. No blood loss means TULSA can be used on a wider set of patients, for example, those on blood thinners. No blood loss also means no emergencies, no grade four adverse events and no need for fulguration. No blood loss means incision free treatment with safety by design. TULSA also completely eliminates overnight stay for the patient, hospital and payer. TULSA patients spend nearly a full 24 hours less in the hospital. And actually, many of the TULSA patients were never in the hospital at all and instead treated in outpatient centers. No overnight means patients are back home by dinner or at the restaurant with their family. Meanwhile, all robotic prostatectomy patients are eating hospital food, laying…

Thank you, Mathieu. The era of interventional MR is here, driven by patient demand for fast recovery, no blood loss and AI based high precision treatment, as stated in Mathieu's remarks. The evolution of MR within prostate cancer has been happening over the course of several decades, but we stand at the frontier of where we are able to bring the MR into the intervention space to treat prostate disease, not just diagnostics and not just track it. TULSA PRO is the key to unlock the original equipment manufacturers of MR devices into the urology call point because of the fact that we now have Level 7 reimbursement from CMS that went live here January 1, 2025. We have introduced, as was mentioned at AUA, the TULSA+ program, which provides a turnkey solution to those urologists who would like to use our technology, but may not have the means to do so based on their current place of service. By doing this, we are enabling the pathway to adoption to accelerate and also providing the original equipment manufacturers the capability to provide a positive cash flow for those that are obtaining the MR plus TULSA solution. This pathway has been developing over a period of time, and we're ecstatic to be able to build off of the profound clinical services that have made this technology what it is today, which is a technology being demanded by patients. That pool is creating enough tension within the marketplace that we are receiving interest from physicians that we may not be calling on ourselves. The Siemens Magnetom FreeMax 0.55 Tesla is the perfect solution for the TULSA+ program for those physicians that may not have a place of service with a magnet to use. It is lightweight. It has the largest bore in…

Thanks, Tom, and good afternoon, everyone. As you heard from Mathieu, our clinical story continues to be strong and clear in terms of both clinical benefits of TULSA and the experience of the patient. TULSA's precision, flexibility, and resulting TAM in prostate disease is unmatched by any competing technology. The clinical data from CAPTAIN will be presented at urological conferences every year for the next ten years as it is the most comprehensive trial done yet and the first level one data for prostate care. And I want to emphasize, cancer outcome is one of the primary endpoint of the trial. We also believe that as more data is published, that it will lead to recommendations from relevant cancer societies, which will most likely lead to guidelines that will effectively require that patients be made aware of TULSA as an option. Adding the BPH module also adds to the physician's ability to create a TULSA day, which from the perspective of ease of scheduling or creating a TULSA program is important. These developments and the fact that we already know that patients choose TULSA when they are given a choice continues to give us significant confidence that we are likely to be one of the first companies to break the barriers and drive mainstream adoption of TULSA. And we believe that now proven superior patient experience with TULSA versus robotic radical prostatectomy will lead to high patient satisfaction and patient demand, which is the same access that drove adoption of the surgical robot in its early days. And TULSA's economic proposition is clear as well. Our urology APC 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 TULSA is better procedure addressing a larger patient population, reimbursed at a higher rate, and also in more settings than any other prostate disease treatment modality. In the interest of time, I'm going to close out our prepared remarks here by summarizing three key points. We are pleased with the perioperative results of the CAPTAIN trial as it showed statistically significant superiority against robotic prostatectomy. We believe that the new TULSA AI volume reduction module to treat patients with BPH symptoms will significantly reduce the procedure time and be very competitive with any other BPH treatment technology. We are limited launching volume reduction volume module with a full release beginning later this year. We see a significant interest in TULSA+ model where we can set up a new TULSA program, not only by providing a TULSA-PRO, but also the MR in a turnkey solution with good financially viable models. 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 a question and answer session. Our first question comes from Ben Haynor at Lake Street Capital Markets. Your line is open.

Good afternoon, gentlemen. Thanks for taking the questions and congrats on the CAPTAIN data. First off for me, just recognizing that the CAPTAIN data kind of came out at the end of the AUA conference, maybe you could share any feedback you kind of received after it hit and anything that you've heard sense from clinicians or other interested parties?

Ben, that's a great question actually. We were producing, when we were developing the trial and so on, most physicians used to tell us that there's already a lot of clinical data on this product. And so the CAPTAIN data, we always used to think, well, it's going to be all about insurance and guidelines. But I think then the feedback actually was far better than I anticipated because I think a number of particularly teaching hospitals wanted to see this data because it gives them the ability to now sort of take it to the mainstream. So I do think that the data is actually more important in terms of driving adoption. And I think a number of physicians are now looking forward to the next step of bringing this to these AUA societies and so on, so that we can start driving towards the guidelines as well as driving adoption. The other thing, Ben, as you know, we're actually the first company, we are the first ones to have actually ever done it. Nobody has even succeeded in this type of trial. So we've always gotten high marks for attempting it, but now everybody is quite pleased that we're at the endpoint. So yes, very positive overall then.

That's great. And then just maybe the plans to present it to commercial insurers, when do you start doing that? Are those conversations already ongoing? What should investors look for there?

Yeah. The conversations have begun. We have a small but very special team that has started. We have, also, I think, at least we can tell you the first couple of months of the year, private insurance were pre approving or approving a number of the treatments. More and more people are becoming aware of the fact that Medicare is paying, and we're starting to see a little bit of that impact. We're particularly starting to see impact on the pipeline there. And we think that given the fact that we're not the first ablative technology in this space and others do have reimbursement, be it a Level 6, we think that we should have a fairly smooth pathway towards getting insurance companies to finally make policies. As far as I'm concerned, you know, they can provide the policies whenever they want to as long as they are preauthorizing or they are providing a number so that patients can be treated, we're going to be okay.

Excellent. And then lastly for me, I don't know if Tom could provide any context or color on the activity at the booth and chats with folks there that on the commercial side, that would be great if you could.

Very happy to do so, Ben. Thank you for the question. Yes, so you're asking specific to the booth activity at AUA just about a week or 10 days ago was fantastic. We were very pleased with the level of interest of physicians across the world, And we were ecstatic to be able to introduce the volume reduction module that Mathieu and Arun spoke to. And the feedback from that was tremendous. The pipeline continues to grow. The economic modeling and the TULSA+ pro form that we shared with interested parties was compelling and has led to a great amount of meetings here in the month of May coming out of AUA. And the great thing about the program that is AUA is that we had the podium presence that Mathieu mentioned. We had the investor analyst events. We had the release of the CAPTAIN perioperative data. So there was a concert of activities that made awareness of TULSA-PRO be of interest to urologists, and we definitely felt that at the booth. So it was a great show.

Our next question comes from John McAuley at Stifel.

Hi, Arun and team. Thanks for taking the questions. First one for me, just wanted to sort of take a look at where we stand on guidance for the year. Apologies if I missed it in your prepared remarks, but you previously said something in the 70% to 75% range. Just want to understand based on earlier dynamics, how you're feeling about that number and sort of the broader commercial and placement setup for the year ahead?

So as mentioned in some of my public remarks, not only at the AUA event, but some other fireside chats, I think that Q1 is in line with the range that we had mentioned of 70% to 75% growth compared to 2024. And we remain steadfast in that commentary. The transition from a placement model, which was the technique through the end of 2024 to a capital model here in 2025, would lend us all to know that it's going to be a back end loaded operation, right? The pipeline continues to grow. But when you transition from being able to place capital with no upfront cost and charging a higher premium on the disposables associated with the procedure to paying for the capital upfront or obtaining the technology through the TULSA+ program, it changes the pipeline in that respect that it's going to lend itself to having a back end loaded reach in terms of the numbers that I'm suggesting here.

Right. That makes sense. And maybe just one more here with a commercial focus again, just maybe for you, Tom. In terms of sales reps and having all the resources you need at your disposal, just where are you now versus where you started? Are you fully ramped to that extent? Yes, sort of just your general progression from a sales force buildup would be helpful.

Yes, great question and happy to speak to the progress. Arun alluded to the special team we have together for health economics and market access. That team is in place. We have a nurse education team in place. We have, of course, our direct sales force in place, and I'm speaking US specific at the moment. In addition to that, we have a market development team that is making great headway with large urology group practice associations. There's some very interesting conversations taking place on a B2B basis. So overall, right on line with where we want to be within basically a six month sprint here now that we're into the month of May. But pleased on the personnel front and pleased with the ability to train and develop those individuals with the expertise that Mathieu and his clinical team already had from the decades of work prior to our commercialization efforts here in 2025. So feeling very good about the US sales team. And we don't spend as much time talking about the OUS business development team, but there's absolutely a great team in place to expand outside the United States and bring this technology to men all over the world.

Our next question comes from Michael Freeman at Raymond James.

I wonder if you could share any color on the first quarter's data that you might be receiving on how the engagement of Medicare and Medicaid patients with TULSA, given this is your first full quarter of CMS reimbursement. Any color on perhaps a pickup in utilization or just general engagement lives with this coverage?

Yes. Michael, this is a very important point. And, I think in the first quarter, in terms of revenue, we were where we expected, and we expected that the reimbursement itself will, at least in the first couple of months, was not going to have a major impact because we were just starting, and a lot of the Medicare payments tend to be 60, 90 days out. So in the early part of the quarter, we didn't see much of an impact. But in the later part, we definitely are starting to see that hospitals are billing and they are getting paid and, that the work has gotten out to the patients and that the pipeline, with respect to a number of sites is building, with the patient population. And, and I think that when Tom talks about the fact that we are far more confident than we have been in our past regarding our ability to deliver the numbers, is much higher because of that. Again, it's a little bit limited in the March, first quarter, but, yeah, I don't see anything that that would cause me to think that there is any issue related to reimbursement.

All right. Thank you, Arun. Maybe this is a question for Tom. I wonder if you could provide, some color on your plans for marketing. And at the AUA proceedings, you discussed the potential for some ex-NFL type spokespeople, some different forms of media that you'd be engaging with? Like when should we expect to see, some profound marketing materials out in the wild?

Great question, and thank you for your interest in knowing, what was suggested at that meeting here on this call. And I apologize for not making those same remarks. But absolutely, whole portion that we're experiencing is that we have patients who are so satisfied with the procedure. There's data that suggests that 9 out of 10 TULSA patients would recommend the procedure to family or friends. We're getting unsolicited inquiries from patients, how can they help spread the word. And so that patient pool, we're starting to harness and get the, what I would call, content collected so that we can begin an immersive campaign on the digital media front, the social media front, the podcasting front, and the list goes on. And there's definitely folks that have been treated that are ex-NFL players, and we'll be able to talk more about that in the coming announcements from the organization. So I'll just need to remain steadfast in letting you know that that's in progress. But that's just a taste of what's to come. And then when? The time is now. So the ratcheting up of the digital marketing efforts and just creating the general awareness and buzz of TULSA-PRO is well in hand. And a lot of it ties back to what you just asked Arun, specific to Medicare is that the words getting out amongst the prostate disease community that you can obtain this treatment from your Medicare reimbursement by being a 65 plus year old man here in the United States Of America. And we're seeing that in the communications that are taking place with our nurse education team as well to suggest that fact is just that, a fact. So hopefully, gave a little bit color in terms of the question that you'd asked.

That's very helpful. And I guess I'll take another crack at an earlier question. I wonder, you talked about back end weighting of your pipeline towards the end of this year to reach your 77% revenue increase goal. I wonder if you could provide any further color on how this pipeline is looking, and what we might be able to expect for pacing throughout the year? Any finer detail you can provide?

So I think there's a whole bunch of different ways we can look at your question and then also my statements around being back end loaded, right, is that there's the traditional brute force method of delivering new technologies in the United States healthcare market, where you're going to the hospital, right, and you're working with the top 50 cancer centers, which I think we'd all agree is not only necessary required, but desired to validate technologies such as TULSA-PRO. And the company has done a tremendous job of doing just that as a number of our highest treating centers fall within that top 50 cancer center umbrella. There's more to come. And to move through that process, unfortunately, it's not an overnight one, but it's a process that does have an end, but it can't end unless you start. So the brute force efforts taking place with those top 50 cancer centers. There's also some burgeoning relationships where we have with other folks in the space regarding MRs, right? We mentioned the Siemens relationship, which I'm certain everyone knows, is not exclusive. So we also have working relationships with Philips and GE and other MR manufacturers. So tying in the fact that we've got this reimbursement component to marry up with their already strong or developing value proposition for acquiring their technology, that's helping to accelerate the pipeline so we can pull forward on opportunities outside of your traditional hospice setting. Henceforth why we're very bullish on the ambulatory surgical center setting with urologists and even the OBL setting depending on the state and location associated with the gypsy rate from Medicare for that particular locale. So all in all, we're right where we're supposed to be, in my humble opinion.

And I think I can also add the point that the waiting list in hospitals is increasing in terms of number of patients who are coming in. You know, Michael, it is a difficult question to answer, because I know you want to know how many deals are going to close next week? And I wish I could tell you that, but I cannot. But I think all of the activities and all of the early indicators are the ones that are giving us that confidence, like more patients are coming in, more reimbursement is working, pipeline is there, the sales team, as Tom talked about, is, in good shape overall. We are increasing our, social media marketing presence. So there's a podcast that will come out in another week or so that is also quite relevant and will be in the social media quite a bit as well. We have some big name celebrities who have undergone TULSA who are now prepared to talk about it. Think you'll be hearing about all that, which will give you more color.

Our next question comes from Scott McAuley at Paradigm Capital.

On the capital revenue side of things for the quarter, think it's about $800,000 I don't know, can you share any details on if those were new installations or those systems that have already been in place that are now kind of converting to the capital model and acquiring the hardware outright? Or any other details you can share on that capital revenue line of things?

I think they're mostly new sites. There might be one that was converted, but they're mostly new sites. So as an additional color, we did have two new sites and one conversion from existing site.

And just lastly on the TULSA+ side. So obviously great to hear about that at the AUA event and reiterated here. I guess any other detail on maybe even timing when that would be available? And then on the economic model, especially if you're looking at helping Siemens with their if you sell TULSA+ it's you get the TULSA+ the Siemens MRI machine. So do you see any benefit from that? And how that agreement is structured if you benefit beyond just placing the TULSA hardware?

Scott, we are working on that. We think we will be there by end of Q3. We think by that time, we should- we're also working in parallel, as Tom described, with certain other hospitals or outpatient clinics where these would be situated. We think by that time, we should be able to announce some deals as well. So, basically, within the next four months or so, we should be able to give you specific types and nature of the deals. Our long term goal with respect to, the TULSA+ model is that we want to focus more on the TULSA revenue side. And the MR itself, we are at the moment flexible because, if it makes sense to come through us, we will do that because I think at the end of the day, it's about driving TULSA procedures. And if it comes directly from Siemens, we're going to be very open about it. But at the end of the day, we are, the financial models and the whole justification for this and then the operation setting up the programs, we will take full responsibility for all of that.

Arun, if I may add some comments, I hope that I wasn't suggesting that TULSA+ is only inclusive of offering a magnet as well. It could very well be that there's a compatible magnet that exists already with the place of service where the customer would like to use a technology, but they need the anesthesia equipment or they need a new body coil or a software revision update. Those are all solutions that we're capable and offering to provide so that with one vendor you're dealing with, and that's profound. So that we can provide soup to nuts the capabilities that you need to launch the TULSA program, and I do stress program because TULSA+ comes with the TULSA program, which includes the launch of the program, not only in terms of clinical support, but staff education, physician outreach, marketing media, PR events, etc., and a whole bunch of other items that go into the TULSA program itself, built around TULSA+. And of course, the epicenter is the TULSA, but we want to provide the solution depending on the customized needs of the end user. So it's mass customization in that respect.

I'm showing no further questions at this time. I would now like to turn it back to Arun Menawat for closing remarks.

Thank you so much. Looking forward to updating everyone in Q2 and our growing pipeline. Thank you again. Have a wonderful evening.

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