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 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, 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 expressed 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, BPH, uterine fibroids, palliative pain treatment and Osteoid Osteoma, and it's 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 Menawat, Profound's Chief Executive Officer; Rashed Dewan, the company's Chief Financial Officer; and Dr. Mathieu Burtnyk, 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 Mathieu in a moment to provide updates on TULSA clinical publication, utilization trends, and the CAPTAIN 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 sales of capital equipment. First quarter 2024 revenue 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 TULSA-PRO consumable inventories at some install sites. While we anticipate that user inventory levels will continue to vary throughout the year, we still expect recurring revenue with growth 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 2023. 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 are $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 for 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 Mathieu.

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 the presentation by Dr. Ethan Wajswol from the Mayo Clinic Florida, on their initial experience with the TULSA-PRO in men with localized prostate cancer. They reported oncologic and CP 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 biopsy, 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 Boström, Chair of the Department of Urology at Turku University Hospital in Finland, who reported the complete 12-month outcomes of the prospective single-center Phase 1/2 study of TULSA in men with BPH. The treatment plan targeted the entire transition zone; including median lobe is present in 30 men. The prior measure of treatment efficacy, the IPSS score improved significantly from 16.5 to 4. Of note, the 75% reduction in IPSS is similar or better than that…

Thank you, Mathieu, and good afternoon, everyone. As you can see from what Mathieu just reviewed, our message is clear. Regardless of prostate disease states or prostate size, TULSA 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, TULSA is incision and radiation-free, one and done 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 bore, 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 TULSA. 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 by parametric 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…

Thank you. At this time, we’ll conduct our question-and-answer session. [Operator Instructions]. Our first question will come from Rick Wise with Stifel. Go ahead, Rick.

Hi Arun, the rest of the team, this is John on for 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, 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.

It's not as steep as 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 -- we -- they purchased the -- assist the recurring revenue module kicks 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 we've said before, it's about leveling and making sure there's not too much inventory at customer's site. 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-on-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 that. So again, I would talk this up to quarter-over-quarter variability, but we don't see it as a steep hill.

Thanks. That's helpful. And 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 and conversations with CMS influenced 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 a 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% revenue 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 talk to maybe acquire based upon usage, I mean, 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 a -- 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 on track to deliver better than 70% margin over time. As we go to this hybrid model, we may reduce the recurring new per patient price from, let's say, around 8,000 to maybe [Technical Difficulty] we don't expect that to go down significantly. And then capital revenues are also high-margin revenue. Hopefully, all of your questions in sufficient detail.

Yes. Thanks. Those are really helpful.

Thanks.

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

Thank you, Operator. Good afternoon, Arun and Rashed. Thanks so much for taking our questions. So I just wanted to follow-on from the -- from John's last question around the recurring revenue versus capital in the 70-30. I assume that irrespective 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?

Yes. I think that is certainly the principle that we're using. And I think as you heard from Mathieu comments, also, we think that TULSA 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, Arun. That's very helpful. So now you've indicated that what new on the reimbursement, and so I won't push on that. However, I want to ask if you could perhaps orient us in terms of how 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 TULSA given essentially long-term to patients not having to go through surgery. So again, without prognosticating on where -- what number you will land, are you able to sort of orient us in terms of how CMS will be driving towards a pinpointed number?

I'm happy to, Rahul. 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 in close proximity to where radical prostatectomy or robotic prostatectomy. 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 treatment discounts and so on and 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 and that's in public domain, if you look into the public documents is that we are closed our 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 that recommended works we've done was based upon the world. And that's an important point because this procedure is a daytime procedure, so the physician gets paid only for the day of the procedure. What that means is that they will -- 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, Arun. And just one last quick question. I know Mathieu talked about the recent clinical data. You've indicated in your press release that recruitment of the CAPTAIN trial is on track to be completed at the end of this year. So are you still looking at interim -- potential interim data at some point? When should we be -- could you oriented as to when we could potentially expect some data on the CAPTAIN trial? And that will be it for me today. Thank you.

Sure. Yes, Rahul, as we've said before, we're on track to produce interim data in the first half of next year. As soon as -- because this is a Level 1 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.

Thank you. [Operator Instructions]. I am showing no further questions at this time. I would now like to turn it back to Dr. Menawat. Go ahead, doctor.

Thank you so much. I look forward4 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.