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Reza Zadno

Good afternoon and thank you for joining us. For today's call, I will provide opening comments and a general business update followed by Sham who will provide an overview of the Hydro robotic systems commercial launch and fourth quarter procedure trends.
Lastly, Kevin will provide additional details regarding our financial performance and initial 2025 financial guidance. Starting with our quarterly revenue results, total revenue for the fourth quarter of 2024 was $68.2 million representing growth of 57% compared to the fourth quarter of 2023.
Growth in the quarter was driven by increased robot sales and increased procedures, both at higher average selling prices and record international revenues.
We exited the fourth quarter of 2024 with the US installed base of 505 systems, representing growth of 60% compared to the prior year period. He sold a total of 190 robotic systems in 2024. On a full year basis, total revenue was $224.5 million representing growth of 65%.
At Proce, our focus is to first transform the global treatment of BPH and become the standard of care. While we have delivered robust growth over the last few years, we only have approximately 10% US BPH receptive market share. Even the size of the BPS market, we still have a long runway in front of us.
In pursuit of our long term vision, 2024 was a productive year for process in two key areas. First, in August, we received FDA 510K clearance for our next generation hydrous robotic system, a major milestone for process. Hydros bring significant advancement over the Aquavi system incorporating years of research, development, and customer feedback.
Designed for mass market adoption with advanced features to enhance surgeons accuracy and enhance the care team's usability experience, we believe hydros will be the platform we can innovate on in the future.
With the introduction of the hydro robotic system, we unveiled first assist AI. This feature combines ultrasound imaging with the advanced planning software to assist urologists in identifying key anatomical landmarks, enabling precise targeting of the resection area using the water jet.
By tailoring the tissue removal plan to individual anatomy, first assist AI aims to enhance procedural accuracy and outcomes.
Structurally, the hydrous robotic system fully integrates an advanced ultrasound system and a single-use digital systems for providing the ability to improve visualization and streamline the operating room setup process.
The hydro hand piece that comes reassembled with a single use digital scope eliminates the need for ciscope reprocessing between procedures.
These advanced features further enhance the efficiency of the procedure and are designed to deliver safe, effective, and durable results for men suffering from PTH regardless of prostate size and shape for surgeon experience.
The market receptivity of hydros has exceeded expectations, which has manifested itself into a robust capital pipeline and a higher hydro selling price.
The second major milestone we achieved in 2024 was related to our prostate cancer initiative. First, we successfully demonstrated hypoagulation therapy does not spread cancer cells throughout the body during resection.
The study published in a peer-reviewed journal, along with other supporting data enabled us to persuade FDA to lift the contraindication for aquaablation procedures in treating BPH patients that also have an active diagnosis of prostate cancer in the United States.
Second, we finished enrollment of PRCT 002, an FDA IDE feasibility study in men with grade group 1 or 2 prostate cancer.
We are excited to share our cancer data at AUA in late April.
Building on the PRCT 002 feasibility data in September 2024, we received FDAID approval to initiate a pivotal randomized clinical study for prostate cancer while also receiving breakthrough device designation.
The trial known as Water 4 PCA is a global multi-center prospective randomized clinical study assessing the safety and efficacy of a coagulation therapy compared to radical prostatectomy in men with grade group 1 to 3 localized prostate cancer.
The study will draw up to 280 patients at up to 50 centers with 10-year follow-up.
We strongly believe that the need to improve safety and quality of life outcomes for millions of men needing treatment for prostate cancer is an area that remains significantly underserved.
We believe hyrolation therapy could become a first-line surgical treatment for localized prostate cancer.
Initiating an FDA randomized trial against cervical prostatectomy is the first big step in pursuing specific treatment of prostate cancer indication, which no other market leading treatment has today.
Given this positive momentum, we believe acrolation therapy is laying the foundation to become the PTH surgical center of care, and Proce is emerging as a leading global neurology company. With that, I will turn the call over to Sham to provide more details on our hydro's launch and fourth quarter procedures.

Shamsha Black

Thanks, Reza. First, I want to reiterate Reza's comments and the team's exceptional performance and execution in 2024 that required an all-in attitude from every part of the organization.
Turning to the Hydro's launch in the fourth quarter, we sold 60 systems, of which 95% were comprised of hydros for an average selling price of approximately $460,000.
After receiving FDA clearance for Hydros midway through our fiscal third quarter of 2024, we transitioned into the fourth quarter with awareness and excitement around the launch starting quickly, which certainly played into our favor as we were able to finish the year very strong.
Initial feedback from customers has been very encouraging. Aside from Hydro's fully integrated and sleek design, surgeons continue to be impressed with the new first assist AI feature, which we believe has the potential to enable all urologists, new and experienced urologists, to improve outcomes for their patients.
Other feedback we received, particularly from hospital support staff, is how improved the surgeon and staff experience is at every stage of the occupation therapy procedure. Specifically, with a single footprint and improved user interface, the integrated tower facilitates efficient operating room set up, procedural workflow, and operating room turnover. Hospital CFOs are also happy to see that the new Hydro's handpiece utilizes a single-use digital scope that eliminates the need for scope reprocessing and further streamlined set up, which saves time and money.
As we enter 2025, we feel very good about the underlying trends, particularly around system average selling prices, customer demand, and high dose user sentiments.
Next, I want to provide details on recent macro events that impacted aqua ablation procedures in the fourth quarter. We have tremendous momentum heading into our seasonally strongest quarter following a very strong September. Given that BPH is an elective procedure, we typically see very strong seasonality in our fiscal fourth quarter. This is due to typical winter elective surgery volume increases after the summer season and is bolstered by the large percentage of patients who utilize the fourth quarter to schedule procedures once they have met annual insurance deductibles. We estimate approximately 50% of all BTH receptive surgeries are Medicare, with the other half being private pay. However, in late September, Hurricane Helene flooded Baxter's sailing facility in North Carolina. Due to the severity of the storm and resulting damage, Baxter's sailing production capabilities were disrupted. Why is this important? First, based on industry reports, Baxter accounts for over 50% of US market share for saline production.
Second, all receptive BPH procedures require the use of saline to irrigate the prostate and bladder during and post-surgery.
As it pertains to enter quarter trends, we saw a more drastic and unexpected decline in the month of November. Based on our assessment of our install base, approximately 50% of our accounts use Baxter as their primary supplier of saline. We saw these accounts either stop performing BPH procedures or significantly reduce volumes, given that BPH is an elective procedure and can be deferred in favor of more critical procedures. From the hospital's perspective, we were informed that even if they were receiving sailing orders, it was typically not at 100% of requested amounts and thus were deprioritizing elective procedures.
To help quantify the impact in the fourth quarter since roughly 50% of our accounts were not impacted due to supplier arrangements or having adequate supply, those unaffected accounts demonstrated normal seasonal strength in the fourth quarter. Conversely, the other 50% of accounts that experienced sailing shortages realized material slowdowns in November with a modest recovery starting in December as sailing deliveries increased. Given this acute macro challenge, we estimate a lack of saline resulted in a delay or cancellation of between 10 to 20% or up to 2000 of our expected procedures in the fourth quarter, which ultimately impacts handpiece order patterns.
In mid November, recognizing that accounts affected by the saline shortage would not be rescheduling procedures in December, we realigned our commercial team's efforts to proactively schedule cases for the first quarter. With an understanding of the anticipated timeline for saline shipments to hospitals, our goal was to ensure procedure volumes in the first quarter returned to meeting our expectations.
As a result of this proactive strategy, we witnessed a strong recovery in procedure volumes in February and feel positive about the momentum heading into March.
As it pertains to recent high dose account launches, given the sailing shortage dynamic, many of our new account launches either restricted the number of procedures they were able to perform or pushed the launch into the first quarter of 2025. In a moment, Kevin will elaborate more on what that what this all means for the first quarter of 2025.
Lastly, I'm once again incredibly proud of the commercial team and their focus and determination to execute through these short-term challenges. I am particularly proud of their resolves and being able to pivot and ensure delayed procedures are rescheduled. Specifically, in January and February, we have enhanced our value proposition to hospitals, and now we have demonstrated how impactful it is to stack multiple arobation procedures in a single operating room day to drive efficiency. This not only helps hospitals, but it also is a significant help to process because it optimizes the team's resources when covering procedures. Moving forward, we believe this will be a driver of increased procedure growth in 2025. With that, I'll send the call over to Kevin.

Kevin Waters

Thanks, Sham. Total revenue for the fourth quarter of 2024 with $68.2 million representing growth of 57% compared to the fourth quarter of 2023. US revenue for the fourth quarter was $60.4 million representing growth of 50% compared to the prior year period.
We generated total US system revenue of $27.6 million representing system revenue growth of 67% compared to the fourth quarter of 2023. In the fourth quarter, we sold 60 new robotic systems at a blended average selling price of approximately $460,000. As anticipated, over 95% of our US system sales were comprised of hydro systems.
Additionally, we sold 3 trade-in units during the quarter, generating total revenue of $245,000. US handpiece and consumable revenue for the fourth quarter of 2024 with $29.3 million representing growth of 36% compared to the fourth quarter of 2023. We ship approximately 8,750 hand pieces at average selling prices of approximately $3200 in the US in the fourth quarter, representing unit growth of 37% compared to the fourth quarter of 2023.
As previously mentioned by Shaam, we estimate the saline supply shortage in the fourth quarter resulted in up to 2000 procedures not being performed. This estimate was derived from an internal quantitative analysis of account historical trends as well as direct feedback obtained through customer interactions and surveys. We also recorded approximately $1.6 million of other consumable revenue in the fourth quarter of 2024.
International revenue in the fourth quarter of 2024 with $7.8 million representing growth of 137% compared to the prior year period. Growth in the fourth quarter was once again driven primarily by strong sales momentum in the United Kingdom.
Gross margin for the fourth quarter of 2024 was 64%, representing an all-time high. Gross margin expansion in the fourth quarter was primarily due to improved operational efficiencies and higher hydro system average selling prices.
Moving down the income statement. Total operating expenses for the fourth quarter of 2024 amounted to $63.4 million compared to $50.8 million during the same period in the prior year and $59.3 million in the third quarter of 2024.
Fourth quarter operating expenses exceeded our previously issued guidance by approximately 3.5%. This variance is primarily attributable to higher variable compensation expenses driven by high gross system overachievement. The year over year increase was driven primarily by increased sales and marketing expenses, mostly to expand the commercial organization and increase general administrative expenses offset by lower sequential research and development expenses following the significant effort around Hydro's development in the 2nd and 3rd quarter of 2024.
We are very pleased with the operating expense leverage we have demonstrated in 2024. When comparing revenue growth to operating expense growth, revenues increased 65% in fiscal year '24 on 30% operating expense growth. We believe our path to profitability is becoming increasingly clear as reflected in our 2024 results.
This clarity is driven by our recent gross margin expansion into the mid 60% range, which is a direct result of our ability to leverage existing overhead at higher revenue levels along with increased average selling prices across the board. Furthermore, our consistent track record of growing revenue at a significantly faster pace than operating expenses continues to reinforce our trajectory toward profitability, which I will elaborate on further when providing our 2025 guidance.
Net loss was $18.9 million for the fourth quarter of 2024 compared to $27.5 million in the same period as the prior year. Adjusted EIDA was a loss of $10.3 million compared to a loss of $23.3 million in the fourth quarter of 2023. Following our most recent capital raise in late October, our cash equivalents and restricted cash balances as of December 31st were $337 million.
Moving to our 2025 financial guidance, we expect full year 2025 total revenue to be approximately $320 million representing growth of approximately 43% compared to 2024. Beginning with US systems, we expect to sell approximately 210 new robotic systems in 2025.
In line with previous years, our robotic sales are estimated to be distributed such that approximately 45% of the total will occur in the first half of 2025. While pleased with the direction of new hydro system pricing, we want to stress that capital pricing can be variable quarter to quarter. Thus, our updated guidance assumes new system pricing to be in the range of $430 to $440,000.
Our primary focus in 2025 remains on the substantial opportunity to sell hydros and Greenfield accounts. However, we are also seeing interest from existing customers who are looking to either replace their current Aquabeam system or acquire a second system, which would be Hydros.
In response to this demand, we are incorporating approximately $3 million in system replacement revenue into our 2025 guidance, though this will predominantly be realized in the second half of the year.
We continue to believe that the replacement opportunity will serve as a significant long term driver for the business, although we are still in the early stages of the adoption curve, considering the 2,700 hospitals in the United States currently offering BPH respective options to their patients.
Turning to US hand pieces on a full year basis, we expect to sell approximately 52,500 hand pieces representing 63% unit growth compared to 2024. We also expect handpiece average selling prices to be approximately $3,200. We expect other consumables revenue to be approximately $8 million for the full year.
Additionally, we expect US service revenue to be approximately $15.5 billion for the full year. Lastly, on international revenue, given strong positive momentum in the United Kingdom and pending launches in Japan, we expect full year international revenue to be approximately $32.5 million representing annual growth of 36%.
Regarding gross margins, we expect full year 2025 gross margins to be approximately 64.5%, which would be an approximate 400 basis point improvement over 2024. First quarter of 2025 growth margins should be relatively consistent to the fourth quarter of 2024.
Turning to operating expenses, we expect full year 2025 operating expenses to be approximately $300 million representing growth of 28% over 2024. In the first quarter of 2025, our operating expense guidance assumes spend of approximately $71 million.
While we are forecasting our 2025 revenue to operating expense ratio will be down compared to 2024 levels, I want to provide additional context. First, we believe our strong balance sheet offers us the flexibility to invest strategically in key areas to drive long-term growth. Specifically, we are making targeted investments to accelerate an enrollment in the Water 4 trial. The quicker we enroll patients, the sooner we can potentially begin generating revenue from prostate cancer treatment.
Additionally, it is important to note that clinical trial expenses are heavily front end loaded as most expenses occur during enrollment. We expect these costs will gradually decrease over time, particularly in 2026. Second, the total incremental operating expenses in our 2025 guidance amount to $66 million.
Of this, approximately $19.5 million is attributed to non-cash stock-based compensation, which supports our expanding workforce and reflects our commitment to rewarding employees with equity, thereby aligning their interests with those of our shareholders. On an apple to apple basis, if you exclude incremental stock-based compensation, core operating expense growth would be 20% compared to 2024 levels.
Finally, consistent with our 2024 guidance philosophy, we aim to provide an initial operating expense target that is expected to remain stable throughout the year with the potential to support higher revenue levels. This approach ensures any revenue outperformance could contribute directly to the bottom line.
Given current interest rates, we expect to generate net interest income of $13.5 million in 2025. When accounting for all these variables, we expect a full year 2025 adjusted EBA loss to be approximately $35 million.
Regarding first quarter revenue. We are forecasting total first quarter revenue of $65.5 million. US system revenue is expected to be approximately $18.7 million and we anticipate selling approximately 10,750 hand pieces in the United States.
In terms of hand piece sales, we did experience some residual impacts from the saline shortage in January. However, February has returned to expected levels, and we are optimistic about the positive trajectory we are seeing in daily procedures.
Additionally, the sailing shortage affected our ability to launch new accounts in both the fourth quarter and early January. However, as we exit February, we have clear visibility and are on track in our first quarter to launch the largest number of accounts ever in a given quarter.
As we have communicated, we have observed that it takes new accounts approximately 2 to 3 quarters to reach a sustained and normal level of monthly procedural volume. To summarize, the challenges experienced in the fourth quarter appear to be largely behind us, and we have strong visibility in the March procedure volumes. At this point, I'd like to turn the call back to Reso for closing comments.

Reza Zadno

Thanksgiving. In closing, I want to provide a brief preview of AUA 2025. AUA 2025 will be an exciting event for process as this will be the 1st year we present cancer results for a population from both of our trials, PRCT 001 and PRCT 002. The data we plan to present will include procedural anatomical capabilities and safety functional outcomes with respect to incontinence and erectile function and oncologic control measured with biopsy.
Given the reproducible nature of our procedure and its safety profile seen during the treatment of BPH, we believe AUA 2025 will provide a glimpse into the future as to how early-stage prostate cancer will be treated.
Furthermore, we are the first company ever to receive ID approval from the FDA to enroll a randomized trial against radical prostatectomy for prostate cancer.
We view this as the first big step in pursuing a specific treatment for prostate cancer indication, which no other treatment has today. Given the amount of quality level one clinical evidence we will be gathering over the next few years, we believe we will be in an advantageous position to drive rapid change in a massively underserved market. And finally, to conclude my prepared remarks, we are seeing multiple factors continue to trend positively, allowing us to execute our long term strategic plan.
In summary, the US Hydro's launch is off to a great start, and customers are thrilled with the improved features. Our pipeline and sales funnel continue to grow nicely at average selling price for hydros that are trending higher than our previous Aquabeam system.
Our international business continues to build momentum in the UK and Japan. Our commercial organization is the largest and most tenured in the company's history, which we believe will lead to increased productivity. We are the first company ever to receive ID approval from the FDA to enroll a randomized trial against radical prostatectomy for prostate cancer.
We view this as the first big step in pursuing a specific treatment of prostate cancer indication. And lastly, following an acute sailing supply disruption in the fourth quarter, we are off to a positive start in the first quarter and feel very confident in delivering another year of strong procedure growth.
We believe these underlying fundamentals reflect the technology that is laying the foundation to become the VPH surgical standard of care and a business that will be a leading global urology company. In closing, I want to thank our employees, customers, and shareholders for all their support to help us along our journey to becoming the standard of care for BPH. We will continue to leverage our commercial and clinical investment to execute on our long term strategy.
Have a great day and I look forward to seeing many of you at the upcoming investor conferences. At this point, we will take questions, operator.

Question and Answer Session

Operator

(Operator Instructions) Craig Bijou, Bank of America Securities.

Craig Bijou

Good afternoon. Thanks guys for taking the questions. I'll lump a couple in here, but they're around the impact from the, saline shortage. So, first, Kevin or Sham, I'd love to understand how.
Maybe you know the 10 to 20% in delay or cancellation procedures and kind of reconcile that with your estimate and how you got to the estimate of the 2000 procedures and. Beyond that, is there, I guess thinking about either the month where you weren't impacted or the hospitals that weren't impacted, is there a way that you can kind of frame what utilization was in that period, and then I'll have a quick follow up on 25 impact.

Kevin Waters

Great. Thanks, Greg. I'll take that. This is Kevin. I, before I get into your question, I just, I do want to reiterate we're really pleased with our overall performance in 24.
We particularly, we had the launch of our next generation hydro system. We saw a significant procedure market share gains, and lastly, we did see significant gross margin expansion, which, we hope is a valid proof point on on a pathway to profitability here. But to get to your question. Specifically, as noted in our prepared remarks, we did estimate the impact in Q4 of up to 2000 procedures from the saline shortage, and this really is multifactorial. We analyze many different variables. I'm going to go through a few of those here today. So first we did attribute an amount lost to procedures.
Frankly, we just know we directly lost as they were scheduled or they were to be. Scheduled and were not performed. That analysis was done two different ways. We had direct customer inquiries in January where we went out and actually performed a customer survey to assess the impact, and then also we had direct knowledge of our reps who, as are currently in every case. We have a high degree of visibility into that factor.
Second, I would say it's more of a quantitative analysis. Internally we understand our Q4 ordering patterns. We performed an internal analysis there regarding normal expectations for growth, particularly coming off a very strong September, and this supported the qualitative analysis we did through surveys and rep feedback. So that's factor number 2. And then lastly, And this is important. We did quantify lost procedures from new accounts that did not start their aqua ablation programs due to the saline shortage. And what I mean by that is, as a reminder, under normal circumstances, once a new system is sold.
It typically does not perform procedures in that quarter it sold, and given this dynamic, we've always talked about that natural leg to utilization. However, because the saline impact was so widespread in the fourth quarter, the reality is the majority of accounts we sold to in the 3rd quarter were pushed into the first quarter, or they were somewhat materially limited from a procedure standpoint. And this is, it's not exact, which is why we provided a range, but I think we feel very good that it was up to 2000 procedures. So that's the first part of your question.
The second part of your question, we definitely saw in quarter trends. October was was a normal October for us. Sure, we started to hear from accounts. We saw some impacts, but when we were on our Q3 call, we did not. I anticipate how widespread this issue was going to become, and we really saw a precipitous drop in November. And then when you get into December, you start to see some recovery in the back half. But more importantly, what we're seeing in Q1 is a lingering impact in January, a very strong February, and a high degree of procedures coming back and accounts being launched in March. So apologies for the length. There, but I hope I answered both of your questions. Yeah.

Shamsha Black

I'll take the second part of it, Craig, on the hospitals that weren't impacted, and I'm glad you noticed that because we did have about 50% of our hospitals that didn't have an impact with saline shortage in the fourth quarter. And when we look at the trends of the of the hospitals that had a normalized utilization in the fourth quarter, we were very encouraged. Performed exactly as we expected in the fourth quarter, which is seasonally a very strong quarter for all procedures, especially elective procedures. I mean, they delivered strong sequential growth in that period of time. And we're in every single case we track these metrics very closely and so we continue to be very excited and bullish about the trends that are going on with our procedures. And if you just look at that segment of customers it performed as expected.

Craig Bijou

Got it thanks guys for the colors. If I could just squeeze in a follow up just on one, it seems like there's probably some puts and takes there still some residual effect, but then you did talk about, seeing, procedures come back that either maybe they were delayed or canceled and and done in in Q1. So just comment on that if you wouldn't mind and and maybe how we should think about utilization growth, overall going forward.

Kevin Waters

Yeah thanks Craig. I'll take all your questions first. I, I'd suggest our Q1 guidance doesn't fully assume that ALL2000 procedures we lost in Q4 come back. I think we get the majority of those back, but there's a practical reality here where they will not all come back in the first quarter. And when you look at our guide in Q1 of 10,750 hand pieces, this does apply this overall utilization relatively flat to Q1 of 24, but as I previously said, we did see lingering impacts from this end of January. So I'd suggest on an apple to apple basis when we're looking at February and March where the ceiling impact is behind us, we are seeing expanding utilization in those accounts. And then just lastly, and this is more of a philosophical comment, we are coming off a fourth quarter, which is the first quarter where we've experienced some significant headwinds on the procedure side of the business. And while we feel very good about the procedure trends we're seeing in the first quarter.
We want to maintain a sense of just cautious optimism here in our guidance to ensure we continue to outperform expectations that we communicate.

Craig Bijou

Thanks, yes. Thanks to hear from you.

Operator

Thank you. Our next question comes from Matthew O'Brien of Piper Sandler. Your line is open.

Matthew O'Brien

Afternoon, I have two questions as well. One of them to start with is just on the ASP side in terms of what you're assuming here for the handpiece number in the US. I think Kevin, it's down about 6.5% year over year is what we're assuming here. That's the bigger, biggest drop I think we've seen from the company. What's precipitating that kind of drop in in on the Hape side.

Kevin Waters

Yeah, so sorry, let's talk specifically about handpiece ASP. So our guidance for the full year implies $3200 ASP for our handpieces, which is actually up slightly from 2024, relatively consistent. I think what you're picking up on Matt in your model is other consumables, which is another part of our business that goes into handpiece revenue, but it's not directly correlated to handpiece ASPs. Other consumables include drapes. Accessories that we sell and we're guiding the number there of about $8 million and that's coming off a $7 million dollar number in 2024 but I think that's why you're getting a lower ASP. The the fact is our handpiece ASP is steady at $3200.

Matthew O'Brien

Got it.

Kevin Waters

Sorry, go ahead. Does that help? It does. I keep forgetting about that, but go ahead on hydros. Yeah, and let me just talk about Hydro ASP. So first off, I'd always say we've always guided relatively conservatively on price. We do expect to get a higher handpiece ASP for Hydros than Aquabeam, but it's important to remember the majority of 25 procedures are still on the Aquabeam system. Aquabeam's 80% of our installed base as we head into 25%. So by analogy, you should assume it's the majority of procedures which are at the lower ASP. But year over year we're relatively consistent.

Matthew O'Brien

Got it. Okay, I appreciate that and thanks for the clarity. Just on the OpEx spend here for the full year, I mean, the total number I think is a little bit higher than what, that you know we have been expecting maybe some of the street, and I think it makes sense with these extra investments that you're making. Can you talk about the upfront loading that's being that's going on right now, especially with Water 4 and then the extra spend there how much faster can you make that enrollment or do we have to wait the AUA to really hear more about it?

Kevin Waters

So OpEx in totality is up about $66 million. I do appreciate that's slightly higher than expectations heading into this call. With that said, I did call out my prepared remarks. About $20 million of that $66 million is incremental. Non-cash based stock compensation that as we head into year 5 of a public company in 2026 that year over year comparable should start to come down. So if you exclude stock based comp, our OpEx growth is actually 20% and not 28%.
And so that's the year over year in terms of R&D investments. We do feel that by making targeted investments we can accelerate water for on the front end.
Think of that spend just to characterize it as about $10 million in 2025 in absolute dollars that is somewhat front loaded as I call. So it does mean that R&D as a total of revenue will be about 25% in 25. That's an improvement from 28% in 24%, but this will start to come down over time. I think we've talked about this business getting to kind of a mid-teens run rate on R&D as a percent of revenue in the near future here.

Matthew O'Brien

Got it thank you.

Operator

Thank you. Our next question comes from Patrick Wood of Morgan Stanley. Your line is open.

Patrick Wood

Beautiful, thank you for taking the question. I'd love to unpack a little bit more on the hydrous feedback, the kind of accounts that you're seeing, how it compares the high volume versus the low volume, or I should say lower volume accounts, like just feedback from how your conversations with customers going on that side, and then I have one quick follow up.

Reza Zadno

Yeah, thanks. As we mentioned in our prepared remark, the Hydros launch exceeds our expectation. Customers are very excited about the features we have put in this robot, the first AI AI. 95% of the procedures are using the AI, and in fact they are making little or no adjustment to what the ultrasound and the computer. Offering and of course other features that help the staff to be more efficient, make the practice more streamline the workflow and of course the hospital CFOs are very excited about the fact that they don't need to re-sterilize the scope. I'm going to let sham to talk about.

Shamsha Black

Yeah, thanks Patrick, this is a sham. I'll take the question on the mix. So just to kind of frame up the conversation. A mix of hospitals. Keep in mind there's about 2,700 hospitals in the US perform BPH. In the early years of commercialization, we hyperfocused on the high volume BPH hospitals, and we've talked about that number being 860, and that was the initial strategy. But what we've seen over the recent years with the momentum is a surging demand by medium and low volume BPH hospitals. Keep in mind these medium and low volume BPH. Hospitals, many of them are very large hospitals. They they historically have not done a lot of BPH. However, with the surge of demand, like I said, with occ ablation, we're seeing many of those hospitals begin to acquire occ ablation systems. So really in some here the mix has been moving over the years significantly more to medium and low volume BPH hospitals as surgeons begin to do more aqua ablation in those centers.

Patrick Wood

Super helpful and then maybe it's a very quick follow up. I don't want to get hung up on the 2000, but any thought on the risk that some of those patients ended up going for procedures that, had a slightly lower saline, obviously depends on prostate size, but a lower saline requirement where they went for a PAE or something else.
Any sense of what the risk of that backlog being pulled away is?

Kevin Waters

No, this is Kevin. We don't feel like we lost any procedures to other receptive modalities. I mean, the reality is where we saw accounts not performing aquablation, they weren't performing any resective procedures. And when you look at the saline used for an o blation, it is less than other comparative receptive technologies. So we, no is the short answer. We don't feel we lost any procedures to other modalities.
Beautiful. Thanks guys.

Operator

Thank you. Our next question comes from Brandon Vasquez of William Blair. Your line is open.

Brandon Vasquez

Hey everyone, thanks for taking the question. I'll just ask to up front here first on the procedure side and I hate to kind of myopically focus on on near term trends, but. In 11 we're talking about utilization that's flat year over year, but we're also seem very excited about what we're seeing in terms of rescheduling accounts, opening record new accounts. I frankly would have expected that maybe to be a little bit higher, so maybe talk to us a little bit about do we see that come through a little bit later, the the follow through on this optimism why way we don't see that a little bit higher in Q1. The follow up question maybe for Sham is just as you look at.
We don't have perfect numbers anymore since this mix of systems and where they're being placed is changing, but regardless, you're probably looking at greater than 50% penetration into high volume accounts have an aquaation system as we go through 25. What does that mean for system placements as we go forward? What does that mean for the durability of system placements, from here? Thanks guys.

Kevin Waters

Thanks, Brent. I'll take the first part of your question, and the Q1 utilization as an absolute metric is heavily impacted by the lingering impacts in January. So without reading into it too much, it really is flat year over year because of the impacts we're seeing in January. But we're seeing tremendous momentum in both February and March, and then I would just remember my comments about us coming off of Q4 and us just being somewhat cautious in our guidance just to continue to ensure we hit our expectations that that we put out there as a company.
You should start to see in the 2nd and 3rd quarter improved year over year utilization, and we're not issuing quarterly guidance at this time for 2 and 3, but what I can say, what our guidance would imply is that we're going to be exiting the year Q4 with utilization growth year over year of 20%. Now I appreciate. That's often comparable. That's not apples to apples, but this business is hyperfocused on utilization expansion, not only driving utilization with new accounts, but ensuring that the accounts were in. We're driving those current surgeons to do more procedures.
And with that, maybe I'll turn it over to Shaam to talk about the second part of your question.

Shamsha Black

Yeah, hey Brandon, sham. I would. Without giving you specific numbers on the on the mix, I will just tell you that our data suggests at the current run rate we have over 4 years left of pipeline available for high volume BPH hospitals, let alone a significant opportunity with low and medium volume BPH hospitals. This doesn't account for second systems. It doesn't account for potential trade opportunities. It doesn't account for other factors in our business in the future which could drive sales. So this is just strictly greenfield sales.

Operator

Thank you. Our next question comes from Richard Neitter of Truest Securities. Your line is open.

Richard Newitter

Hi, thanks for taking the questions.
Just, the first one I think you had mentioned that as you were launching Hydros initially you had distraction to the kind of consumables or hand piece sales force. I'm just it didn't really or maybe I missed it but I didn't hear you guys talk about that at all. Sounds like maybe that's in the rearview. Could you discuss what if any impact kind of was there in the. In the fourth quarter lingering into the first quarter and can we assume that's behind us moving through 22 to 42 and then I have a follow up.

Shamsha Black

Richard, I'll take it's a sham. I'll take the first one on the rep impact. We did talk about that in Q3 and Q4 as we as we have a large field team need to be training on hydros.
If there's a silver lining in the saline impact as we accelerated training in the fourth quarter and as we turn the year turn to the new year here, we have we have that completely behind us. And so in January, every rep is fully trained in the hydro system and that's no longer something we see as an impact to utilization.

Richard Newitter

Okay great and then just on the replacement revenue I think you said that would that that's 3 million anticipated for 2025, should we be thinking that that's or or can you talk a little bit about, customers that have maybe purchased the system within the last 1 to 2 years and then maybe some of the some of the older portions of your install base I would imagine.
There's a true up kind of ASP for new, more recent purchasers than there is for for those who have an older system and are and are upgrading. Should we assume that the ASP was obviously something less than 460,000, but I mean, should we assume that's in the 500 to 100,000. Range on average any help there would be helpful. Thank you.

Kevin Waters

Yeah, let me address your comments on ASPs and replacements and then I turn over to sham about kind of our our focus and opportunity in both Greenfield and replacement. So I would suggest that the replacements that we've talked about in 2024 are not reflective of what an ongoing replacement cycle should look like for average selling prices. And what I mean by that is the replacements that we executed on in Q3 and Q4 were really for Aquabeam customers that had purchased in the previous 6 months and therefore you're correct that those ASPs are fairly low. They're in the 50 to 100k range, and those are almost more as exchanges as opposed to replacements given Hydros was not available when they bought Aquabeam. As we move forward, I think we get into a much more. Normal replacement opportunity where if you have a hydro, excuse me, if you have an Aquabeam that you bought 5 years ago, the reality is you're going to buy hydros at the same ASP that a Greenfield would buy. But if you bought Aquabeam in the last 2 to 3 years, you will get some discount. But that discount is more in the 100 150 k range, not 300, which you've been seeing in the last 6 months. So that's on ASPs, and I hope you appreciate the difference there between kind of The replacements in an initial launch which address near term customer concerns and then just a normal ongoing replacing cycle and I'll turn over to Sham to kind of talk about the strategy and the why here. Hey.

Shamsha Black

Richard, so I think it's an interesting dynamic that we have going on. The hydros, the hydro's value is compelling for our customers. The customers are excited and we are getting inbound interest into looking. Second system or trade opportunities and what we're trying to do with our sales team is ensure that we don't lose focus. We face very disciplined on our on our effort to become the standard of care and BPH. In order to do that, we need to continue to focus on greenfield hospitals and then focus on opportunities where we believe we can do trades in an expeditious fashion. So selling a trade, even though on the outside. May seem like it's faster. It takes a lot of time and energy to work through a hospital purchasing process and a trade, and so that that takes away from Greenfield selling time. So the focus for our capital sales team in 2025 continues to be greenfield sales when those opportunities come for trades, and they will be a larger sales than we've seen in 2024. We will take advantage of those as long as it makes sense and doesn't distract from greenfield sales.

Richard Newitter

If I could just one follow up on that one follow up on that do. Is there a downward pressure on the overall company ASP from that 3 million relative to the 435,000 or that 435,000 is separate from replacement revenue?

Kevin Waters

That that is separate. So just to be specific here, we guided the 210 systems at an ASP of $430 to $440. Those are completely separate than the $3 million in incremental revenue that you could describe that rich to about I think of 10 replacements somewhere in that range in 2025 to get to that $3 million dollar number.

Richard Newitter

Thank you.

Operator

Thank you. Our next question comes from Chris Pasquale of Nephron Research. Your line is open.

Chris Pasquale

Thanks. International really seems to have inflected in the back half of 24. I know it gets overshadowed by the US business, but we saw a big step up there. Guidance for 25 seems to imply continued momentum and the utilization number in particular, in the fourth quarter seems to have been quite strong. Maybe just spend a minute on where you're seeing the strength there and what the next dominoes are for you guys in terms of OUS expansion.

Kevin Waters

Yeah, maybe I'll start with just providing some help on what was comprised of international and consistent with previous quarters, the upside in the fourth quarter is primarily demand driven from the UK, both on new systems, but as you pointed out, some really nice procedure growth. And utilization and I think our 2025 guidance really reflects the fact that we're just getting started in the UK and have a lot of runway left here. I'll turn it over to Shaam to perhaps talk about some of the other regions that were making some initial inroads, but at the same time we do not have. A significant amount of revenue in 25. Yeah.

Shamsha Black

I think I'll touch on the UK's just a little bit more color and then and then and then talk about outside the UK. So the first thing I would say is I've been spending some time over in the UK just due to the momentum that's happening in the business there, very akin to our experience in the US We're now seeing the government hospitals adopt the technology, but also the private sectors that started to adopt in a very nice fashion in the UK. I was over there, met with the with the executive team of the largest IDN, and they are looking for a strategy to expand alco ablation throughout the country.
So just really exciting opportunity there in the UK to become standard of care for BPH procedure as well. Outside the outside of the UK, our primary focus is the direct businesses in Japan. We now have established reimbursement. The KOL network is building 2025. Will be a very much a focus on expanding the install base to a heavy focus on greenfield sales and like the US, we'll start in the UK.
We'll start to build a procedure business over years as you build that direct team in Japan. And beyond those two countries we've got to obviously have a large opportunity, and we're focused on countries where we believe we can move the market in the years to come. So building do market development activities and building KOLs in those markets.

Chris Pasquale

Thanks, and then this is just one detail one, but did the size of the water 4 trial change from what you had contemplated back in the fall? I thought I heard 180 before and now it's 280, but maybe I misheard.

Reza Zadno

No, we have said waterfall would be 280 patients randomized study in the United States.

Chris Pasquale

Okay, thanks Reza.

Operator

Nathan Treybeck, Wells Fargo.

Nathan Treybeck

Hi, thanks for taking the question. I'm just circling back to the replacement opportunity, is there any way you could kind of help us understand the gross margin impact from replacements and then just generally for 2025? How should we think about gross margin cadence through the year and where do you think you can exit in 4?

Kevin Waters

Yeah, so, and Richard just asked this question. The replacement opportunities is factored into our gross margin guide. We're assuming about 10 replacements at a $300,000 ASP in the US. We're assuming 210 green fields in the US at 43,000 to $440,000. So our margin expansion takes into account any dilutive impacts that we would have from replacement opportunities.
The second part of your question on gross margins, Nate, can you just repeat exactly just so I can make sure I answer your questions. Yeah. Basically, how do you expect gross margin to trend through the year and the exit rate in Q4?
Yeah, so we actually just to remind everybody this year 2024 with Q4 margins of 64% and full year margins of 61%. Now that was a meaningful improvement from 52% in 2023. And then we have guided on a full year basis here to kind of right mid 64.5% that would suggest an exit velocity of somewhere in the 65 to 6 66% range in the fourth quarter, and we're pleased with that growth, but I don't want anybody to think we're disappointed given How robust 24 was. The reality is 24 was always transformational for us from a gross margins. This was the year we saw a meaningful impact of leveraging our overhead. It's the year we moved in fully to our new facility and took advantage of that. And on top of that, we had a nice surprise in 24 with significantly averaged.
Selling prices, particularly on the capital side of the business. So given where we're at today in the mid-60s, we don't expect the same magnitude of move in 25, but again, we're going to be exiting the year close to 66%, which we believe importantly will be another proof point on a very clear pathway to profitability.

Nathan Treybeck

Okay. And so at this point my understanding is there, there's a rep at every procedure, and I believe you talked about this in the past, but eventually you want to move beyond that where you don't need a rep at every procedure, I guess. What are you thinking about timing in terms of, transitioning how, the procedure is done, how many reps you need in the field? Thanks.

Shamsha Black

Yeah, hey, it's sham. So I think there's a couple of factors here that we're considering before we make that decision to be something that's that's more widespread. Number one is, in high volume hospitals there are 12 BPH surgeons. And so, our opportunity to sell to the to the other surgeons that aren't using our technology becomes more and more challenging when we're not in the operating room.
It's an unbelievable sales opportunity for our field team to be in those cases and cross selling to those to those other surgeons. The other piece of this is simply the efficiencies of the procedure. When we're in there and we're helping staff and there's a lot of different staff that covers procedures, we're able to get through a lot more cases in the day when our reps are in the room.
With hydros, that equation could change for us. That's one of the reasons why we're excited about hydros is our ability to allow more and more different staff members to have to have, a procedure that can be more efficient for our surgeons. So the short answer to your question is we plan to pilot some of these hydrous accounts in 2025 and we'll see how that goes. And over time we definitely will see more and more independent surgeons, but for now we see it as an opportunity when we're in those hospitals to bring more and more surgeon technology.

Operator

Mike Kratky, Leerink Partners.

Mike Kratky

Yeah, hi everyone, thanks for taking our question.
Kevin, maybe just to go back to what you talked about, I think you've historically talked about 65% gross margins being in the range at which you could start to get a pretty clear path to profitability. So is it fair to think if you're exiting this year at 66, I mean, not to get ahead of ourselves, but does that give you pretty good confidence that 2026 then is the year that that could happen and then have one follow up?

Kevin Waters

Yeah, how about I'm going to keep my commentary focused on 25, but I think they'll help with your question anyhow, and I'm going to talk about EO in particular. So we didn't provide quarterly EIDA guidance, and I'm going to talk about the fourth quarter.
However, we do expect to see sequential improvements in EEO throughout the year. And we do believe exiting 25, we're going to show a very clear pathway to sustain profitability. However, we're not going to comment today on what specific quarter that's going to be or actually comment on 2026 either. But to get to our implied guidance, you get to a place exiting 25 again where it should be very clear that this is a business with significant top line growth, expanding margins, leveraged OpEx, and no question about our ability to generate profits moving forward.

Mike Kratky

Okay, yeah, super helpful and then maybe you just want to follow up, earlier you mentioned your guidance implies your hand piece ASP, I think is up slightly, but most of that still coming from Aquabeam. So can you help quantify how much higher your hydros hand piece revenue is or your sorry, ASP is versus Aquabeam on an apples-to-apples basis?

Kevin Waters

Yeah, it's too early to comment on specificity. The reality is we're still working through a lot of the Hydros negotiations. Our installed base of Hydros is still less than 100 systems that we've sold, so we feel good that we're getting increased ASP, but it's probably too early to comment on what that delta looks like as we're working through multiple customer negotiations. Is that fair?

Mike Kratky

Yeah, understood. Thanks very much.

Kevin Waters

Yes, thank you.

Operator

Josh Jennings, TD Cowen.

Joshua Jennings

Hi, good afternoon. Thanks a lot for taking the question. I guess maybe be a hard one to answer, but I was hoping you could just share you what competitors are doing as Procept is driving the aqua ablation treatment towards standard of care. Are you seeing significant counter marketing in the field there any technology enhancements that you guys that are on your radar love to just hear how you're thinking about the competitive landscape and if it's getting tougher or if you guys are even more confident.
After the past multi-year run you've been on.

Reza Zadno

Hi, Josh, this is Reza, definitely on the competitive front in the last couple of years, technologies we see are generally in the non-reactive area on the respective, especially we do not see companies running even an FTA trial. And also, so this is for BPH treatment. And as far as the prostate cancer, yes, we see some technologies for focal therapy. And we are still the only company running an FTA randomized study ID in the United States. So we are very confident with our technology. I'm going to let sham, he can add more color to this.

Shamsha Black

Yeah, hi Josh, a sham. I think, on the receptive front we've made, significant progress in our journey to become standard of care. We'll exit 2025 at roughly 20% of the receptive market. And when you look at the competition, the receptive market, the gold standard for 100 years has been TERP, and who sells turp?
There's a lot of different products to sell turp, so we don't really have a direct competitor when it comes to TERP, which is a massive advantage for aquablation and for Procept. The other companies rather touched on the non-receptive technologies which tend to be office-based, but in the hospital market we feel like we've got an unbelievable opportunity to really continue our journey of becoming standard of care.

Joshua Jennings

Awesome and just wanted to check in on your system guidance and assumptions baked in and then we're going to see some early prostate cancer data at AUA is my thanks sorry I may have missed part of the prepared remarks session earlier, but I mean, are you baking in any prostate cancer indication driven system sales in 2025 system guidance or is that not baked in? Thanks a lot.

Kevin Waters

No, that's our guidance does not assume any revenue or systems or procedures attributable to prostate cancer.

Reza Zadno

So as far as the second part of your question, definitely we are very excited. We'll give an update on what for enrollment there will be, data presented on PRCT 001 002. And so these are some of the information that will be presented at AUA.

Joshua Jennings

Outstanding, thank you.

Operator

Thank you. We have no further questions at this time. I'd like to turn it back to retazado, CEO, for closing remarks.

Reza Zadno

I want to thank everyone for attending our earnings call. We hope to see you at the upcoming conferences and. Have a nice day.

Operator

This concludes today's conference call.
Thank you for participating and you may now disconnect.