PROCEPT BioRobotics Corporation

Good morning and welcome to ProCEP Biorobotics first quarter 2025 earnings conference call. At this time, all participants are in listen only mode. We will be facilitating a question answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Matt Baxo, Vice President Investor Relations for a few introductory comments.

Good morning and thank you for joining ProCEP Biorobotics first quarter 2025 earnings conference call. Presenting on today's call are Reza Zadno, Chief Executive Officer, Kevin Waters, Chief Financial Officer, and Shams Shablak, Chief Commercial Officer. Before we begin, I'd like to remind listeners that statements made on this conference call that relate to future plans, events, or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. While this call is being recorded, while these forward-looking statements are based on management's current expectations and beliefs, these statements are subject to several risks, uncertainties, assumptions, and other factors that could cause results to differ materially from the expectations expressed on this conference call. These risks and uncertainties are disclosed in more detail in ProCEP Biorobotics filings with the Securities and Exchange Commission, all of which are available online at .sec.gov. Listeners are cautioned not to place under reliance on these forward-looking statements, ProCEP Biorobotics Center will speak only as of today's date, April 24, 2025. Acceptance is required by law. ProCEP Biorobotics Center takes no obligation to update or revise any forward-looking statements to reflect new information, circumstances, or unanticipated events that may arise. During the call, we will also reference certain financial measures that are not prepared in accordance with GAAP. More information about how we use these non-GAAP financial measures as well as reconciliations of these measures to their nearest GAAP equivalent are included in our earnings release. With that, I'd like to turn the call over to Reza.

Good morning, 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 a commercial overview. Lastly, Kevin will provide additional details regarding our financial performance and updated 2025 financial guidance, beginning with our quarterly revenue results. Total revenue for the first quarter of 2025 was $16.5 million, and $39.2 million, representing growth of 55% compared to the first quarter of 2024. Growth in the quarter was driven by increased U.S. systems and handpieces sold as well as record international revenues. We exited the first quarter of 2025 with a U.S. installed base of 547 systems representing growth of 55% compared to the prior year period. We sold a total of 42 robotic systems in the first quarter of 2024. robotic systems in the first quarter of 2025, turning to the global macro environment, specifically our exposure to tariffs. As a reminder, following the establishment of full Medicare coverage in 2021, we initiated U.S. commercial operations in earnest at a time when the pandemic had exposed significant vulnerabilities in the global supply chain. In response, we took proactive steps to de-risk our supply chain by sourcing the majority of our strategic components in the U.S. For components that could not be sourced within the U.S., we took deliberate steps to maintain significant inventory levels. This approach not only mitigated the risk of supply disruption, but also helped reduce our exposure to potential tariff escalations. For example, greater than 95% of the direct material cost of our single-use handpiece is sourced in the United States. Regarding our robotic system, our primary exposure to China lies in the ultrasound system. However, we have typically maintained a robust supply of inventory for these critical components. Kevin will provide additional detail in the guidance section. However, given our strong inventory position of ultrasound units and the fact that all products are assembled in California, we currently anticipate only a modest impact to 2025 gross margin. That said, we have taken a conservative approach to our 2025 gross margin outlook and will continue to closely monitor potential headwinds that could affect fiscal 2026. Turning to clinical updates. In March, at the 40th annual European Association of Urology Congress in Madrid, primary end-point results from the Water T3 randomized control trial were presented. Water T3 is an international prospective multi-central study comparing aquabulation therapy to laser nucleation in prostate sizes 80 to 180 milliliters. This study treated 186 men and reported three months primary safety and efficacy endpoints. Water T3 will also follow patients up to five years. At three months, aquabulation therapy delivers similar symptom relief to laser nucleation while demonstrating a 0% transfusion rate and significantly lower rates of ejaculatory dysfunction and incontinence. Notably, the rate of stress incontinence was 0% among aquabulation patients. These results add to our growing body of clinical evidence and support that aquabulation therapy is highly reproducible in treating prostates of all sizes with a low learning curve. Aside from the clinical outcomes, we believe the Water T3 results will be instrumental in helping modify global urology guidelines in the future for larger prostates. Next, I want to provide a positive update regarding U.S. Medicare coverage. Effective April 6, 2025, first coast and Novatos, two of the largest regional Medicare administrative contractors, positively updated two key local coverage determinations, or LCDs. We estimate first coast and Novatos account for approximately 30% of all Medicare patients in the United States. Regarding the LCD changes, first coast and Novatos removed three key limitations. Age-based restrictions for men over 80, voided volume thresholds that impacted patient in retention, and the requirement to measure prostate size via trans rectal ultrasound. These changes significantly streamline the pre-procedure workup and should expand access to aquabulation therapy for a broader patient population. With that, I will turn the call over to Sham to provide more detail on first-order commercial performance.

Thanks, Reza. Starting with U.S. procedures, in the first quarter we sold 11,235 hand pieces representing -over-year unit growth of 65%. As we noted during our fourth quarter earnings call, we experienced some residual impacts in the saline shortage in January. However, volumes returned to more normalized levels in February, with March demonstrating strong growth compared to the prior month. As of the end of March, we believe the ongoing issue is behind us. The first quarter of 2025 was an incredibly important quarter for the company to execute our plan, given the macro factors from the fourth quarter. In addition to a strong hand piece quarter, we saw a greater number of accounts launch their aquabulation program in the first quarter compared to any previous quarter. As I look back over the last quarter, there are three key takeaways regarding the Hydro's account launches. First, internally we proved we can execute supporting a large number of new accounts on accelerated timelines. Second, hospital customers are very motivated to launch and promote their Hydro system. And finally, given the number of accounts that were launched in the first quarter and the daily procedural normalization post saline, we have a high degree of confidence we will continue our procedural and system momentum as we progress through 2025. Turning to Hydro's, with the launch of Hydro's last year, we've seen a noticeable increase in engagement with large strategic companies in the U.S. and the United States already on the right end. And based on the feedback we have received, we believe momentum is being enhanced by a few key factors. First, with the size of our install base and the growth across hospitals and procedures, many of these new hospitals now view Procept as being on par with the most well established med tech companies in the U.S. Second, they see Hydro's as a potentially game changing technology, bringing advanced capabilities to a large established searchable category that has been stagnant for years. And third, we're hearing a strong desire to standardize ophthalmology therapy across their hospital networks, driven by the consistent reproducible outcome and the operational efficiency that it brings. Many of these IDNs have also expressed a strong interest in growing patient volumes and view Hydro's as an enabling technology to support that goal. Of the 43 systems sold in the first quarter, approximately 45% were associated with IDN bulk buys executed at the corporate level. Furthermore, approximately half of Hydro's placements went to high volume BPH hospitals, with the other half being low or medium volume BPH hospitals. Given this dynamic, we believe Hydro's is resonating with large strategic IDNs in all hospitals, regardless of historical BPH volumes. Regarding the broader capital equipment environment, while market uncertainties present challenges, we have demonstrated a strong track record of selling capital at incrementally higher prices driven by the underlying value of ophthalmology therapy to the patient and hospital customers. Based on daily conversations with prospective customers in our pipeline, we do not sense any material shift in overall sentiment. We believe ProCEP is in a strong position to continue to grow the install base for the foreseeable future. Many hospitals associate robotic surgery as a long-term strategic priority to grow revenue and market share, and thus are less likely to cut investment in this area, even if macro conditions moderately worsen. Second, we are in the early innings of a new product launch that is gaining traction. The number of low and medium volume BPH hospitals acquiring Hydro systems continues to increase, giving us confidence in our ability to expand into these hospital segments and continue on our path to becoming the BPH standard of care. Lastly, I want to touch briefly on our international performance. International revenue in the first quarter of 2025 was $8.9 million, representing growth of 104% compared to the prior year period. While our international business remains primarily driven by capital sales, we are beginning to see meaningful revenue sales winds from procedural volumes, particularly in the United Kingdom, where increasing utilization is becoming a meaningful driver of the overall business. This is very encouraging as we now have many examples across the UK of launching robust and durable oscillation programs in both the NHS and private sector. These real-world examples are critical for developing a community of self throughout the UK. With that, I will turn the call over to Kevin.

Thanks, Sham. Total revenue for the first quarter of 2025 was $69.2 million, representing growth of 55% compared to the first quarter of 2024. US revenue for the first quarter was $60.3 million, representing growth of 50% compared to the prior year period. We generated total US system revenue of $18.7 million, representing system revenue growth of 32% compared to the first quarter of 2024. In the first quarter, we sold 43 robotic systems at a blended average selling price of approximately $435,000. Looking ahead, we expect a small percentage of Hydro's placements to come from legacy Aquabane system replacements. In these cases, particularly with established customers, we anticipate pricing to be largely consistent with that of a new system. Notably, during the quarter, one customer replaced their Aquabane for Hydro's. As a result, while 43 systems were sold, the US install base grew by 42 units, reaching a total of 547 systems. This reflects continued momentum in system adoption and the value customers place on our next generation technology. Turning to US handpiece and consumable revenue. Revenue for the first quarter of 2025 was $38 million, representing growth of 61% compared to the first quarter of 2024. The 11,235 handpieces sold in the United States were at average selling prices of approximately $3,200, representing unit growth of 65% compared to the first quarter of 2024. We also recorded approximately $2.1 million of other consumable revenue in the first quarter of 2025. International revenue in the first quarter of 2025 was $8.9 million, representing growth of 104% compared to the prior year period. Growth in the first quarter was once again driven primarily by strong sales momentum in the United Kingdom. Growth margin for the first quarter of 2025 was 63.9%, consistent with the fourth quarter of 2024, and up 750 basis points year

-over-year.

The -over-year margin expansion was driven primarily by improved operational efficiencies and higher average selling prices compared to the first quarter of 2024. Moving down the income statement. Total operating expenses for the first quarter of 2025 amounted to $71.6 million compared to $52.7 million during the same period in the prior year. We believe our path to profitability is becoming increasingly clear as reflected in our recent performance. This clarity is driven by our gross margin expansion into the -60% range, which is a direct result of our ability to leverage existing overhead at higher revenue levels, along with increased average selling prices for systems and handpieces. Net loss was $24.7 million for the first quarter of 2025 compared to $26 million in the same period of the prior year. Adjusted EBITDA was a loss of $15.8 million compared to a loss of $20.4 million in the first quarter of 2024. Our cash, cash equivalents, and restricted cash balances as of March 31st were approximately $319 million. Moving to our 2025 financial guidance. We now expect full year 2025 total revenue to be approximately $323 million, representing growth of approximately 44% compared to 2024. We continue to expect to sell approximately 210 new robotic systems in the United States, with pricing in the range of $430,000 to $440,000. Our primary focus in 2025 remains on the substantial opportunity to sell high-gross and durable systems. 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. Therefore, we are guiding the total full-year US system revenue of approximately $95 million, which includes Greenfield sales and to a lesser extent, replacement systems. 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. Heading to US handpieces, for the full year, we continue to expect sales of approximately 52,500 handpieces, representing a 63% increase in unit volume compared to 2024. We remain confident in our visibility into new account launches and quarterly procedure volumes, which contributed to our out performance in the first quarter. We are maintaining handpiece average selling prices to be approximately $3,200 and are increasing other consumable revenue expectations to be approximately $9 million for the full year. Additionally, we expect US service revenue to now be approximately $16 million for the full year. Lastly, on international revenue, given strong positive momentum in the United Kingdom, we now expect full-year international revenue to be approximately $34.5 million, representing annual growth of 44%. Turning to growth margins, the current tariff landscape remains highly fluid. That said, we believe we are well positioned to manage both growth margins and overall profitability in this environment. To

clarify

our exposure, tariffs primarily impact our ultrasound system and associated component source from China. Should current rates remain elevated at 145%, we estimate a potential gross margin headwind of approximately $5 million in 2025, which would equate to a 150 basis point reduction from our guidance of 64.5%. With the majority of the impact expected in the second half of the year. While we believe there's a reasonable likelihood that tariffs could moderate over time, we felt it important to outline the potential downside scenario that rates remain unchanged. Although we are not yet providing guidance for 2026, we are actively evaluating operational mitigation strategies that could reduce future exposure. Importantly, we remain confident that the current tariff environment does not compromise our path to achieving our long-term profitability objectives. We will continue to closely monitor developments and provide timely updates as needed. Turning to operating expenses, we continue to expect full-year 2025 operating expenses to be approximately $300 million, representing growth of 28% over 2024. In the second quarter of 2025, our operating expense guidance assumes spend of approximately $75 million. Additionally, given current interest rates and cash balances, we expect full-year interest and other income of approximately $9.4 million. Taking all relevant factors into account, we continue to anticipate a full-year 2025 adjusted revenue and cash balance to be approximately $35 million. We believe potential tariff-related headwinds can be largely mitigated through operational efficiencies identified across the organization. At this point, I'd like to turn the call back to Reza for closing comments.

Thanks, Kevin. In closing, I want to provide a brief preview of AUA. We are currently in Las Vegas for the 2025 AUA conference, and it is also the fourth consecutive AUA analyst day. Tomorrow we will be video webcasting the event live starting at 8 a.m. Pacific, 11 a.m. Eastern. From a logistics point of view, it is very important to note that the location of our event has been moved to the Aria Hotel. In conference room, Joshua, 9 and 10. If you are planning to attend in person, please update your meeting location to the Aria Hotel. Tomorrow will be an exciting event for ProCEP, as this will be the first year we present prostate cancer results for aqua population from a combination of 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 the incontinence and erectile function and oncologic control. Given the reproducible nature of our procedure and its safety profile seen during the treatment of BPH, we believe tomorrow's analyst day will provide a glimpse into the future as to how low and intermediate risk prostate cancer patients could be treated. Furthermore, we are the first company ever to receive ID approval from the FDA to enroll a randomized trial comparing surgical therapy against radical prostate cancer. We view this as the first crucial step in pursuing a specific prostate cancer treatment indication, which no other treatment has today. Given the amount of level one clinical evidence we will be gathering over the next few years, along with our breakthrough device designation to fast track approval, we believe we will be in an advantageous position to drive rapid change in a massively underserved market. 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 U.S. Hydros launch is gaining momentum with our pipeline and sales funnel going nicely. We launched significantly more Greenfield accounts in the first quarter compared to any other quarter. We exited March with very strong procedural momentum and viewed the sailing disruption to be behind us. We feel very confident in delivering another year of strong procedure growth. Our international business continues to build momentum in the UK. We are the first company ever to receive ID approval from the FDA to enroll a randomized trial comparing a surgical therapy against radical prostate cancer. Lastly, based on current inventory levels and limited exposure to foreign suppliers, we believe the impact of tariffs on 2025 cross margins to be very manageable and we have reiterated our adjusted guidance for fiscal 2025. We believe these underlying fundamentals reflect the technology that is laying the foundation to become the BPA surgical standard of care ID approval from the FDA 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 BPA. At this point, we will take questions. Operator?

Thank you. To ask a question, you will need to press star 1-1 on your telephone and wait for a name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question will come to the line of Matthew O'Brien from Piper Sandler. Your line is open.

Good morning. Can you guys hear me okay? Good. Excellent. Thanks for the questions. For starters, I would love to hear, and I think Sham started to address it a little bit, but I would love to hear a little bit more about the CAPEX environment. It is coming up in every conversation I think everybody is having at this point in terms of the environment potentially slowing with Medicaid cuts, etc. You just had your best Greenfield quarter ever. Maybe just talk a little bit about what you are seeing in the market in terms of buyer interest in the system and then conversion rates versus what you were kind of expecting if anybody is slowing things down just given the environment or even canceling converting over. Just a bigger discussion on what you are seeing on the CAPEX side because again I think it is getting quite a bit of attention and then I do have one follow-up.

Hi, Matt. It is Sham. Thanks for the question. So I would start by saying we haven't seen an impact when it comes to our capital interest in the hospitals interest in acquiring Hydros. We have daily conversations. Our pipeline is at an all-time high when we look at opportunities that have now entered the buying process for Hydros. So we haven't seen any material shift in the sentiment as far as the excitement around acquiring our technology. One thing I think we are different. We are in a unique position. We are still early innings when it comes to the opportunity we have with the number of hospitals that still remain. And we are talking about thousands of hospitals that still haven't acquired AquaBeam or Hydros to this point. And we are continuing to build the pipeline. The other thing is due to the disruptive nature of this technology, due to the adoption with procedures, we now have patients demanding the technology. Surgeons, hospitals don't want to lose those patients. And we are in a unique position right now to continue to grow that pipeline. And reimbursement supports the procedure as well. So there's a lot of things going in our favor even in this environment. And last thing I'd mention is the relationship with IDNs continues to strengthen. We talk about this routinely. We are at a point now where we are being invited to corporate environments where we have the key executives at large IDNs talking to us about long-term strategy. All those things play into our favor over the course of this year and the future.

Got it. Appreciate that feedback. And then the second one is really on the handpiece side. That was really strong in the quarter. And I know there was probably some deferral of cases in Q4. It's been difficult to figure this out. How many of those may have gotten pushed from Q4 to Q1? Are there other dynamics underlying this that are just even stronger in terms of maybe market share and certain geographies that are looking above what you had initially anticipated again, given how strong the handpiece was in Q1?

Thanks. This is Kevin. So you are correct. We did see some impact from deferrals in the fourth quarter. But those were largely offset by the sailing impact that still lingered into January and February. I would characterize that dynamic as net neutral for procedures in Q1, which really means the Q1 procedures are just driven by the strength of the business as opposed to backlog coming into Q1, which was offset by the continued weakness into January and lingering into February.

Thank

you. Thanks.

Thank you. One moment for our next question. Our next question will come from the line of Craig Bijou from Bank of America Securities. Your line is open.

Good morning, guys. Thanks for taking the questions and congrats on the strong start to the year. I wanted to follow up on Matt's question on handpieces and maybe ask in a slightly different way. But I know you called out March as kind of getting back to normal. And I wanted to see if maybe you could provide a little bit more color on what the procedure volume growth was in March, at least directionally, versus some of the other quarters and maybe how we could think about utilization in March and how that carries forward for the rest of the year.

Yeah, I'll start. Maybe I'll let Sham come in. But we were really pleased with kind of return to normalcy in March coming out of the January and February lingering impacts from saline. Moving forward, our guidance in Q2 and Q3, it assumed very similar utilization rates to the first quarter. And then you get into the fourth quarter and you're looking at utilization, it would be up over 20%, which would imply a full year 10% utilization growth, which we think is fairly healthy, keeping in mind how many new accounts that we're adding to the business in 2025, which we've consistently said is just a natural headwind to utilization. And it takes about two to three quarters, excuse me, for our accounts to get up to the corporate average. We're really pleased directionally with where utilization is trending.

I would just add, I'm sorry, Craig and Sham, that we continue to have great insight into daily procedures, number of new surgeons, surgeon retention rates, and exiting March into April, we were on track to where we want to be as far as launching new accounts and hitting the surgeon retention rates and adding new surgeons at the rate we need to be to hit our forecast. Saline is behind us. I think March is the first month where we felt confident that the dynamic that's now gone and we're now back in full swing as far as daily procedure rates.

Great. That's helpful. And I know you guys have talked a lot on this call about the multi-system orders for the IDNs. And you have been talking about it for a number of years now, and it seems like maybe there was an acceleration. And I know you guys, I heard you guys mention Hydros is one of the drivers, but anything else that's changed there, it's great to see, and I'm just curious as to what those discussions look like now versus where you guys were a year ago. And how should we think about that impact in years going forward?

Yeah, Sham, I'll start by just really mentioning the kind of the current environment has adjusted or changed to answer your question simply because hospital systems now can look back at existing programs they've had for years and versus it being kind of a vision of establishing an occupation program, they can go back and look at the data and say, is this working? And so the fact that they can now look at their own hospitals, they can see what the reimbursement looks like, they can see how patient volumes are growing at the hospital, they can see that they're adding new surgeons because of this technology, all of those reasons are the reasons why they want to now have more strategic or corporate conversations. I will tell you that we've been having IDN purchases all along. This is now just becoming more of a partnership versus just taking one hospital at a time through the IDN. So the ability now to have those conversations will serve us really well over the coming years. That's the partnership I think we have with IDNs. Whether it's a bulk buy or one purchase at a time, this is more about the corporate level supporting their local hospitals and that's kind of the evolution of the conversation that's happened.

Great, thanks

guys.

Thanks, Ray.

Thank you. One moment for our next question. Our next question will come from Patrick Wood from Morgan Stint. The line is open. Beautiful.

Thanks guys. I'd love to start actually this time on OUS. Obviously, anytime NICE supported technology being the most stingy organization of all time, it always gets a lot of attention that way. Great result there. I'm really curious how you're thinking about resourcing OUS, growing there, because obviously it's a massive opportunity and it's still incredibly early stage. So I'm just trying to work out there's a lot to go in the US as well, but how do you balance those? How should we think about the OUS ramp over the next three, five years, whatever?

Hey Patrick, it's Sam. Thanks for the question. We are very excited about the international opportunity globally. The one thing that we've spoken about in the past and I'll just reiterate is we want to do things the right way and when we go to a market, we want to make sure we win in a big way. We're early as a company. We've got a lot of opportunity and we want to be very disciplined in making sure that when we go to the country that all the boxes are checked. There's a lot of boxes that need to be checked to have a winning technology in many of these markets. So we've made the decision via a lot of efforts we've made on getting good reimbursement, good support from NICE, as you mentioned, to focus on the UK as the next big market of ours. We've now continued to build the team there and we've used some great growth. We also believe the formula we're using in the US can be reproducible and so we're following a very similar structure and growth format that we had in the US. We've now taken that to the UK. The next market we'll go to is Japan and outside of those three markets we continue to do a lot of market development activities. We've got interest from well over 20 countries, significantly more than 20 countries, that we decided not to go into right now because we want to support the markets we're in and win in those markets. But that does serve very well for us in the years to come.

Beautiful. And then very quickly as a follow up, the US side of things, we're obviously moving to a permanent code. There was some noise in the court around the physician fee, any sort of updated thoughts on how you're thinking about the pro fee and then the cap change on the code side of things for this year?

Yes, the rough process for the category one is complete. So the proposed ruling we expect to come out this summer. We feel very good about the physician payment because this procedure is very similar to other receptive procedures. So we anticipate this to be similar to other receptive procedures. What's important is this does not impact APC level 6, which is the ultimately the ROA to the hospital. That remains at 9200.

Love it.

Thanks so much.

Thank you. One moment for our next question. Next question, we'll come to Richard Neuweter from Truis. Your line is open.

Hi, thanks for taking the questions. I just want to talk about the concept of high volume, low volume, or low to mid volume hospitals. You mentioned I think that the proportion going into low to mid was about 50 percent and going into high volume was about 50 percent. Can you just remind us what that ratio has looked like over the last one to two years so we can get a sense for whether you're at a point where maybe you're more reliant on medium to low volume accounts to drive higher utilization? If that's a consideration that we should be thinking about, is it harder to get incremental utilization per account from here on or just kind of steady she goes is what you've been doing? Hey, Richard. It's Sham.

I think we think very differently when you think about utilization and when you think about the size of hospitals. The one thing we've proven up to this point is if a hospital has a low or medium volume, BPH volume, when they acquire occubalation technology, we've seen significant increases in utilization. In fact, in many cases, turning them into high volume BPH hospitals. We're going to talk more about this tomorrow on our investor day, but this is something that actually has been very supportive for our hospitals to show they can move surgeons, they can move market share. This is what, when you look back historically over the last 25 years and you see the most successful robotic surgery companies, this is what they've done. The most successful companies have been able to move market share by hospitals establishing robotic programs. This has been a great success of ours and we have over 2,000 hospitals that are low and medium volume BPH hospitals that we're just getting started in. As far as your question on the shift, you know, we used to be about 70% of our hospitals were high volume hospitals and now we are starting to see a shift down in that because of the addition of low and medium volume hospitals. So very exciting times for us and we continue to validate that this technology is adopted by all.

Right, and maybe just for Kevin on the tariff and follow up here, is the message that you could potentially see up to 150 basis point gross margin headwind, obviously, if everything stays the way it is right now, but you offset that in the P&L, further down the P&L, such that, you know, the messages you absorb or tariff headwind, should it approach 150 basis points? Or there is a potential 150 basis points risk to your reiterated EBITDA guide?

Yeah, I'll go through that, Rich, in detail here. So the impact we discussed today, it does assume that the tariff rate for imports from China stay at the 145% level and this expense of 5 million max exposure would be weighted towards the second half of the year. Obviously, this is a very dynamic situation. I mean, we heard recent commentary yesterday that would be positive around this rate. But specific to your question, the 5 million dollar impact would be 150 basis point reduction to our .5% margin guidance if nothing else changed here moving forward. With that said, and to the second part of your question, even with this headwind, we are affirming our EBITDA guidance if margins trend even towards the low end. The reason being is we have identified offsets in our operating expenses to mitigate a 5 million dollar impact. So margins would be reduced, but the overall profitability of the company would be unchanged. At the end of the day, a 5 million dollar impact is approximately 2% of our operating expenses and we think as a management team, we could go find that to support continued EBITDA. And then lastly, I think it's important, we don't believe the current tariff environment would material impact our pathway to profitability in the future here. We're working on a lot of things as we head into 26.

Okay,

thank you.

Thank you. One moment for a nice question. Next question on the comfort line of Brandon Vasquez from William Blair. Your line is open.

Hi everyone, thanks for taking the question. I wanted to go back to the IDNs first and maybe ask the question a slightly different way. I'm kind of curious, what does the utilization in these accounts look like? And in part I'm asking because it sounds like this is an effort that you historically used to go in, find one KOL, put yourself in the account and expand from there, but now you're having from the top, the corporate organization push this. Is there a difference in the rate of utilization? Is there a difference in the peak utilization or the just raw number of procedures that are coming out of these accounts? Curious on any dynamics you can talk about there?

Hey Brandon, it's Sham. So I think that this is something that over time we'll be able to hopefully give a lot more detail on. But I'll tell you that initially it's still driven the same way and I'll tell you why we think that there could be favorability to it in the future. Right now it's driven by surgeons. Surgeons drive this technology. They get excited about it and they come in from the physician office level finding patients and bringing them to the hospital. And patients find those surgeons that are doing occultation. However, we do have IDNs that have patient navigation programs. These are employed employees of the hospital network that work to educate the referring physicians on new technologies the hospitals offer. And that helps to drive this funnel of patients to drive more patients for occultation. We have IDNs currently that are very interested in ProCEPT, educating those nurse navigators, educating that pathway. And those are opportunities that exist from the corporate level. That's an example of something I think can help utilization. There are other areas that we're talking to strategically also. But at the end of the day, these decisions are surgeon decisions. But anything that IDNs can do to educate and raise awareness is always helpful for utilization.

Okay. And maybe as a follow up to that, I'll throw two here because one's a follow up to that question, is basically maybe the more blunt way to ask the question I was trying to ask is, it looks like the goal of robotics often from your experience in intuitive and then now what you want to do in ProCEPT is standardized, right? You want to standardize to a certain care pathway. Do the IDNs, the increasing adoption of IDNs, to ask it more bluntly

give

you a clearer pathway to standardizing on ProCEPT? And then separate unrelated question. Now that you guys have a second randomized controlled trial with Water 3, can you just spend a couple of minutes on what's the game plan here in terms of using this potentially for societies, change guidelines, and then maybe open some new international markets? Thanks guys.

Yeah, I'll take the utilization question and I'll pass it over to Reza. So, you know, I think that, you know, what we're seeing on the IDN level is absolutely, you know, an interest in doing more on the utilization front. So, you know, I'll tell you that tomorrow we'll talk more about it at our Investor Day. But these are all things that I believe ultimately will help the population become the standard of care. They do want to standardize. At the end of the day, these are certain decisions, but anything that the hospitals can do to help with training, to help with education, is going to help standardize the procedure. And those are the conversations we're having right now. We're making a big investment in the Strategic Accounts team to be able to support the hospitals. And that is definitely something that's on their mind, is how do they get more population procedures in their hospitals? Related

to your second part of the question, the water tree data were presented a few weeks ago in Madrid, as early as it is, but the initial response has been very positive. This was a randomized study against the nucleation. And multi-center, multi-country net was shown with zero percent transfusion, with similar efficacy results, but better safety outcomes. So, this will definitely will be in the future, getting to the international guidelines, and this further strengthens our clinical benefits, our population. So, definitely, as you said, the goal is to get into the guidelines.

Thank you. One moment for our next question. Our next question will come from the line of Josh Jennings from TD Callan. Your line is open.

Hi, good morning. Thanks for taking the questions. I was hoping to just ask about PRCT 001, 002, those results coming out. I think you'll have 12-month results on 002, and maybe 001 as well. But, help us understand the plan just in terms of filing. And Water 4 is going to generate level 1 evidence, but in front of level 1 evidence, will ProCEP move forward with filing for internal use tools claim for localized prostate cancer?

Thanks, Josh. This is Reza. We are very excited about the event tomorrow. I think more importantly is hopefully tomorrow that we will answer recently questions about do we spread cancer? Can we treat the lesion in different locations of the prostate? Can we treat in the peripheral zone or the transitional zone? And why is this randomized against prostatectomy? So, tomorrow data, 70 patients, PRCT 001, 002 with 3 months and 6 months data on 50 patients will be presented. Yes, we can potentially obtain a tool claim, but we know ultimately in order to our goal is to expand the market of prostate cancer. And that's why we have started Water 4 randomized study against prostatectomy so that we can generate level 1 data in order to get to guidelines.

Thank

you.

One moment for our next question. The next question will come from Chris Pasquale from Nefron Research. Your line is open.

Thanks. I wanted to follow up on tomorrow, first a follow up on reimbursement. You talked previously about some potential investment options you were evaluating to try and speed up the timeline for Water 4. Not to get ahead of ourselves and what we're going to see tomorrow, but what are your latest thoughts on the enrollment timeline for that study?

We'll provide a lot more detail tomorrow, but we've been consistent in stating that we're going to be shortening that by we're going to be kind of unencumbered. This would be approximately a 24 month enrollment. I think we think a good result is to try and shorten that by six months, and that's the additional investments we're talking about. We're going to give an update tomorrow kind of on timeline, but you should think of this as an 18 to 24 month enrollment.

Okay. That's helpful. And then could you just talk about the geographies represented by First Coast and Novatos?

So, as I mentioned the preferred remarks, you know, removing some of those obstacles definitely streamlines the patient pre-workup. The age removal, the minimum void impacting patients with retention, and the measurement of the prostate side, these are all the obstacles that are removed. And definitely age is not removed on all MACs, but the other two we believe this could be a precedent for the other MACs to remove the way they have to measure the prostate using trans rectal ultrasound. All of this will facilitate

using the technology on patients. Chris, I just add that I'm not sure everybody understands that not every urologist owns the trans rectal ultrasound in their office setting. And so that their ability to use trans ultrasound is not in question, but their ability to have access to it can be a challenge. So that's a big one. And then rather touch on the other ones. These are all smaller wins in the sense of like one at a time, but when you add all these small wins together it becomes a big win because then these surgeons don't think of this as a workup nightmare so to speak. It becomes way easier to schedule patients.

That's helpful. Thanks.

Thank you. One moment for our next question. For our next question we'll come to the line to Mike Crackley from Liric Partners. Your line is open.

Hi everyone. Thanks for taking our questions. Have you seen any shift in the typical prostate size where occubalation is being used as physicians get more and more familiar with the system or as they've incorporated it into their practice broadly? Or as hydrosis started to roll out? And then maybe just a follow up. Can you share any feedback that you hear from your customers on surgeons perceived value proposition of occubalation across different prostate sizes in BPH?

Yes. So the distribution curve that we have been showing in the last couple of years remains similar. And the majority of their prostate that are treated are below 100 milliliters. So that distribution curve has not changed. Sham, do

you want to talk about the approach? One of the big benefits of occubalation is you don't always know what size the prostate is going to be when you go into surgery. I think that surgeons are consistently doing their best to gauge what they're dealing with. Whether you get in the operating room and many times they're surprised by what they're dealing with. And the occubalation therapy technology allows you to treat prostates of all sizes consistently, efficiently, and with consistent outcomes that we just saw with a randomized study with water three. And so I think what you're going to see now is many surgeons who felt like they needed to refer out large prostates. Many surgeons who felt like they maybe needed to go get trained on a technique for large prostate. Surgeons that were doing prostatectomies, et cetera. Those are patients that I believe they now have the data. They now have the support to show consistent results with occubalation therapy. We've had this data for a long time. There's over 150 peer review journals. But this water three study continues to validate that the randomized data we're investing in is very consistent across the board. So I think we'll see this continue to be a big benefit for us long term.

Super helpful. Thanks very much.

Thank you. One moment for our next question. Next question comes from Nathan Trebek from Wells Fargo. The line is open.

Hi. Thanks for taking the question. Hey, Kevin. I just wanted to clarify something you said earlier on the ASP. I mean, I think going into the year you expected about three million from system replacements. Can you just clarify the ASP differential between replacements and Greenfield? Thanks.

Yeah. So it's an interesting dynamic and it's going to vary based on the age of the system. So for example, we did have one replacement in the first quarter. But given the age of that AquaBeam system, the pricing wasn't terribly different than to a new Greenfield account in the quarter, which is why we didn't separately call it out. And that dynamic, I think, is fair. If your AquaBeam is, I'll call it three plus years old. And then we obviously are offering some type of trade in discount. But we haven't been specific on what that is. This is going to vary from customer to customer. It's also why we incorporated a full year system revenue number into guidance to kind of help everyone back into what a replacement could look like.

Okay. That's helpful. And then on the prior just deferred procedures, you know, exiting, I think in Q4 you had 2000 procedures that were deferred. You talked about some lingering impact in January and February. I guess where does the deferral stand today? And over what time frame can you recapture these procedures?

It's really difficult to say. I think it's a At the end of the day, the 2000 procedures, the 2000 procedure maximum that we felt were deferred in the fourth quarter, they're a small part of the 52,500 procedures we're going to do here in 2025. But we would expect these to kind of be coming back throughout the year. I mean, BPH is an elective procedure and therefore backlock procedures are probably just likely to filter in evenly throughout the year.

Thanks. Thank you. One moment for our next question. Our next question comes from Michael Sarcone from Jeffreys. Your line is open.

Good morning all and thanks for taking the question. Just a follow up on the capital equipment environment. Can you maybe give us an update on where you stand in terms of duration of a typical sales cycle these days? It doesn't sound like you're seeing any changes, but we'd love an update there and then maybe comment on what kind of visibility you have into the funnel.

Hey Michael, it's Sham. So to answer your question, no changes as far as the sales cycle. Six to nine months continues to be a typical sales cycle. You will see some things move faster, you'll see some things go a little bit longer depending on budgetary kind of constraints. But six to nine months is a fairer kind of thought as far as when you think about our pipeline and how quickly we can move through. I apologize, what was the second part of your question?

I can take it. Just kind of visibility into the funnel. Specifically, we haven't seen any change in conversion rates. We haven't seen any change in fallout. It's been very consistent over the last 12 to 24 months.

Got it. Thank you. For the follow up, maybe just give us an update on the competitive environment in BPH and what you're seeing. Where are you taking share? Maybe any commentary on what you're, you know, the latest and greatest on the prostate artery embolization front.

Yes, so I addressed the PAE first. You know, PAE has been around for more than 25 years and typically done by radiologists. Efficacy is similar to non-resective, but the issue over there mostly on durability and the data show that they have about 20 percent retreatment at one year. So these are obvious barriers, so we don't see that as a competition. As far as where we take market share, when we ask the question, you know, the answer we typically get is definitely, we have said in the past, it is terp, green light, and for larger prostate, definitely in nucleation. New technologies that are coming on board, what we see mostly, they are various forms of non-resective procedures. So this is what we are seeing on the resective side. We are not aware of anybody coming up with a technology or running a clinical study on the receptive side.

Great,

thank you. One moment for our next question. Our next question will come from Ryan Zimmerman from BTIG. Your line is open.

Morning, thanks for taking the questions. Just a clarification on the capital sales, Kevin, I think last quarter, and correct me if I'm wrong, the 210 unit guide was separate, the 95 million specifically, was separate from the 3 million replacements, and is the 3 million now included in the 95 million? I just want to be clear because at 210, at 435 a piece, I mean, you're coming in at like 91 million and change.

Yeah, so it's correct. So the 3 million would be incremental to the 210 to get you to the 95 million dollar system guide.

Was that the case last quarter, Kevin? As I interpreted it, it wasn't. I may be mistaken.

Yeah, sorry, same last quarter, but we did not guide a total revenue number, and we wanted to clarify that on this call, but nothing has changed in terms of our expectations.

Okay. And then just to be clear, I think this was asked, but again, I apologize. I'm just trying to get some clarification questions. The 2000 procedures that were deferred, you're not assuming, or you are assuming, that those were fully recouped in the first quarter?

We are not assuming that. What we're saying is we would suggest that any deferrals from Q4 to Q1 were largely offset by the sailing impact that we saw in January and February, so we would consider that impact negligible in the first quarter, and if they were to come back, we feel that they're going to come back throughout the year, not in any one given quarter.

Okay. Very clear. Thank you for the clarification.

Thanks, Ryan.

Thank you. I'm not showing any further questions at this time. I would like to turn the call back over to Reza Sadno, the EO, to close remarks.

Yeah, thanks for attending this meeting. Hope to see you tomorrow at our event and see you in the future conferences. Thank you very much. Have a nice day.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.