PRCT - NASDAQ

Good afternoon, and welcome to PROCEPT BioRobotics Third Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. I would now like to turn it over to Matt Bacso, Vice President, Investor Relations, for a few introductory comments.

Good afternoon, and thank you for joining PROCEPT BioRobotics third quarter 2025 earnings conference call. Presenting on today's call are Larry Wood, Chief Executive Officer; and Kevin Waters, Chief Financial 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 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 PROCEPT BioRobotics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date, November 4, 2025. Except as required by law, PROCEPT BioRobotics undertakes 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 Larry.

Thanks, Matt. I'm excited to be on the call today to discuss our third quarter results and share some early insights from my first couple of months in the role. First, let's talk about the quarter. We demonstrated strong execution and results with total revenue for the third quarter of 2025 of $83.3 million. Strength in the quarter was driven primarily by U.S. capital systems shipped, which totaled 58 in the quarter. While we have begun to see some large hospital systems more carefully scrutinize capital spending in light of evolving macroeconomic conditions, we delivered a strong capital quarter. Capital pricing has remained stable. And importantly, we continue to maintain solid visibility into our pipeline and remain confident in our ability to finish 2025 on a strong note. On procedures, my handpiece sales were roughly in line with expectations. Procedure utilization is an area we are highly focused on improving moving forward and believe it's a key to unlocking long-term value. As part of this increased focus, we're implementing several organizational changes and launching multiple initiatives aimed at improving our commercial execution. One example is increasing focus on improving our speed of new account launches. While HYDROS launches consistently deliver strong procedure adoption post launch, the timing from sale to first procedure is highly variable. The situation presents 2 challenges. First, it delays the realization of utilization benefits from newly installed systems. And second, hospitals are holding excess HYDROS handpieces that were purchased at the time of the capital sale. To address this, we launched an initiative with clear goals and metrics aimed at achieving procedural targets in the shortest possible time after a sale. Early results have been highly encouraging, and we plan to expand this program in the fourth quarter and fully implement it in 2026. Reflecting on my first few months, I've had the opportunity to observe procedures and speak with a number of key opinion leaders across the field. What I've seen has only deepened my conviction in this opportunity and validated the reasons I chose to join PROCEPT. When I think about our long-term potential, it really starts with the fundamentals. BPH is massively undertreated. Many patients fear the side effects of drugs or surgery and avoid therapy altogether. What they don't realize is delaying therapy can significantly affect their quality of life and even lead to more serious health issues. At the same time, many patients are still unfamiliar with Aquablation therapy and the life-changing benefits it can offer. Our clinical value proposition is strong. The Aquablation procedure and the supporting clinical evidence are highly compelling, especially on the outcomes that matter most to patients. I think the team has done an excellent job driving early adoption and supporting clinical users. But if we want to expand our impact, we must do more foundational work to increase therapy awareness and drive patient activation, which is something I have a lot of experience from my time at Edwards. This will in part -- this will be a core part of our near and midterm commercial strategy. We are also sharpening our focus internationally. We see strong opportunities in markets that value transformational therapies and are willing to support access for patients. We will increase investment and organizational support in these regions accordingly. Additionally, to support our core initiatives, we've made a number of organizational changes. Pooja Sharma has joined us as Chief Marketing and Strategy Officer. She brings deep experience from Edwards Lifesciences, where she led marketing and strategy for the transcatheter heart valve business. Her background in driving category leadership and therapy development is exactly what we need at this stage. Also, Stephen McGill has been promoted to Senior Vice President, General Manager, International, and will now report directly to me. Stephen has done an outstanding job leading our international business. With added investment and focus, I'm excited to have him on the leadership team. This also enables our incoming commercial leader to focus exclusively on North America. By organizational change and influx of new talent can create some short-term disruption, my primary responsibility is to ensure that we have the right people and the right objectives to drive long-term success. Overall, procedure volumes have been solid year-to-date. However, given the size of the BPH market in the United States, we are still only scratching the surface and have tremendous opportunity to further accelerate procedure growth. Looking ahead, Aquablation is a highly differentiated solution for BPH patients. While our current evidence is already strong, we will continue to invest in building a robust clinical foundation and ensuring patients are aware of Aquablation therapy. We also see longer opportunities beyond BPH. Specifically, we believe Aquablation has the potential to be a compelling therapy for prostate cancer. This is an area we are actively studying in the WATER IV clinical trial. High-quality evidence generation will be a foundational part of our expansion strategy in this space. In closing, I'm energized by the opportunity ahead. The leadership team has been incredibly supportive, and we are committed to advancing this therapy for the patients that need it. We will build a world-class marketing organization to activate patients and accelerate utilization. We will invest meaningfully to expand market awareness. We will accelerate new account launches and drive international growth with a focused market-specific approach. With that, I'll hand it over to Kevin to walk through the financials for the quarter. Kevin?

Thanks, Larry. Total revenue for the third quarter of 2025 was $83.3 million, representing growth of 43% compared to the third quarter of 2024. U.S. revenue for the third quarter was $73.9 million, representing growth of 42% compared to the prior year period. Turning to U.S. procedures. Handpiece and other consumable revenue for the third quarter of 2025 was $44.4 million, representing growth of 50% compared to the third quarter of 2024. We also recorded approximately $2.4 million of other consumable revenue in the third quarter of 2025. In the third quarter, we sold approximately 13,225 handpieces, reflecting 51% year-over-year unit growth. While we navigated a period of commercial leadership transition, our team continued to deliver solid performance and momentum. Turning to U.S. robot placements. We generated total U.S. system revenue of $24.7 million, representing system revenue growth of 26% compared to the third quarter of 2024. In the third quarter, we sold 57 new HYDROS systems. The pricing for our systems was at an average selling price of approximately $435,000. Additionally, we placed 1 HYDROS system under an operating lease model. As a result, we exited the third quarter of 2025 with a U.S. installed base of 653 systems, representing an increase of 47% compared to the prior year period. Lastly, international revenue in the third quarter of 2025 was $9.4 million, representing growth of 53% compared to the prior year period. Moving down the income statement. Gross margin for the third quarter of 2025 was 64.8%, representing an increase of 160 basis points year-over-year. The year-over-year margin expansion was driven primarily by greater organizational effectiveness. Total operating expenses for the third quarter of 2025 amounted to $77.2 million compared to $59.3 million during the same period in the prior year. Net loss was $21.4 million for the third quarter of 2025 compared to $21 million in the same period of the prior year. Adjusted EBITDA was a loss of $7.4 million compared to a loss of $12.4 million in the third quarter of 2024. Our cash, cash equivalents and restricted cash balances as of September 30 were approximately $297 million. Moving to our 2025 financial guidance. We continue to expect full year 2025 total revenue to be approximately $325.5 million, representing growth of approximately 45% compared to 2024. We now expect to sell approximately 213 new robotic systems in the United States in 2025. As a result, we anticipate system sales in the fourth quarter to total approximately 65 systems. Turning to U.S. handpieces. For the full year, we now expect sales of approximately 52,000 handpieces, representing a 61% increase in unit volume compared to 2024. The reduction in fourth quarter handpiece sales guidance reflects modest headwinds related to the optimization of field inventory resulting from the variable launch timing of recent HYDROS placements. We are maintaining handpiece average selling prices to be approximately $3,200 and other consumable revenue expectations to be approximately $9.5 million for the full year. Additionally, we expect U.S. service and other revenue to now be approximately $17.5 million for the full year. Lastly, on international revenue, given strong positive momentum, we now expect full year international revenue to be approximately $37.5 million, representing annual growth of 56%. Turning to gross margins. We now expect full year 2025 gross margin to be in the range of 64% to 64.5%. This would imply a fourth quarter gross margin of approximately 63%, which includes approximately $2 million of tariff expense. Turning to operating expenses. We continue to expect full year 2025 operating expenses to total $302 million, representing a 29% increase compared to 2024. After considering all relevant factors, we continue to expect a full year 2025 adjusted EBITDA loss of approximately $35 million. I would now like to pass it back to Larry for closing comments.

Thanks, Kevin. Before we open the line for questions, I'd like to take a moment to provide perspective on fiscal 2026 to give investors early visibility into how we are approaching the year ahead. For fiscal 2026, we are currently anticipating total revenue in the range of $410 million to $430 million. The outlook reflects our current momentum in capital sales even in an uncertain macro environment and incorporates our expectation of modest procedural headwinds in the first half of 2026 when we make targeted strategic investments to enhance our commercial capabilities and operational excellence. These initiatives are designed to drive sustained long-term utilization growth and position us for durable profitability. We will continue to invest in our strategic priorities to drive long-term growth and do not expect these investments to impede our progress toward achieving profitability. Lastly, in late February 2026, we plan to host a formal Analyst Day in New York City, where we will outline multiyear revenue guidance and provide updates on our marketing priorities, R&D initiatives, prostate cancer trial and profitability targets. We look forward to providing a more robust long-term view. With that, we are happy to take questions. Operator?

[Operator Instructions] Our first question is from Matthew O'Brien from Piper Sandler.

Great. And Larry, I hope things are going well here early in your tenure as CEO. Would love if either you or Kevin would talk about the capital environment because that number in the quarter was quite strong, clear acceleration. I know some people were worried coming out of Q2 about the capital environment. So can you just talk about the strength that you saw there, especially in an environment that you say is weakening a little bit? Is it really HYDROS that's starting to see an inflection or maybe build some of the backlog even further? Maybe just talk a little bit more about what you're seeing there. And then I do have a follow-up.

Yes. Maybe I'll start, Matt. This is Kevin. I appreciate your question. So as you observed, we're really pleased with the capital team's performance in the third quarter. I think if you recall, in the second quarter, we said that we had some variability in timing, particularly with some of our IDN partners, and that still continues to be the case. So when we highlight perhaps some future weakness in capital, it's really more around timing and capital allocation with our customers as opposed to any worsening of the macro environment. And the team executed very well in the third quarter, and we feel good about that momentum heading into the fourth quarter where we're expecting somewhere in the kind of mid-60 range of systems, but feel good about the team, the capital environment and performance.

And then, Larry, a question directly for you. 2 months on the job now, I would love to hear a little bit more about what you've seen in your seat, maybe low-hanging fruit, some longer-term things that you can focus on and forgive the long-winded question. But the near-term changes on the org side probably make people a little bit nervous, especially as you're guiding for next year. So why the confidence in even providing that 2026 revenue guidance, which basically brackets where the Street is at? Can you just talk a little bit about your confidence there?

Thanks for the question, Matthew. I will say my first 8 weeks have been really incredible here. I've thoroughly enjoyed getting involved with the management team and digging in and I've had the chance to spend some time in the field and talk to a number of our KOLs. And for those of you who know me from my time at Edwards, I spent 40 years at Edwards and probably thought I'd never leave. And -- but spending the time on the Board with PROCEPT, it just felt like such a spectacular opportunity to change medicine again. And my time here, everything is really just validated it, spending time with the KOLs, seeing procedures, seeing what we can deliver for patients. I think the challenges in front of us are -- I don't think we've necessarily told our story yet. I don't think we've told our story to clinicians, and I certainly don't think we've taken the story to patients. And I lived a lot of this journey when I was at Edwards. We had a lot of early success with transcatheter heart valves. But then we sort of hit a little bit of a wall once we got through the early adopters. And we had to do a lot more with therapy awareness and with patient activation and all of those things. And that was one of the big things that attracted Pooja to come here because we get an opportunity to sort of transform medicine again. But when you start with a procedure that I think is so highly differentiated, but isn't necessarily respected as such, I think it just creates this enormous opportunity that we can change the practice of medicine. And so I'm super energized by it. We wanted to provide guidance for next year. I know being a new CEO coming in, I'll just be real frank about it, there's a lot of people that just assume somebody is going to be overly conservative with the approach and that creates uncertainty for folks. And so we just wanted to give you a range. We feel great about our future. We feel incredibly optimistic about our future. We have a lot of initiatives that we've already started and some of the pilots that we've run, I feel very encouraged by. So I'm just really excited about the opportunity, and we look forward to sharing more with you in February. I'll have more time in the role. Pooja actually starts tomorrow. So she'll have a little bit of time in the chair to be able to lay out some of her plans. And we're excited to share them with you and give you more long-term view in February.

[Operator Instructions] Our next question is from Brandon Vazquez from William Blair.

First, I just wanted to focus a little bit on the quarter specifically and some of the updates and then maybe a follow-up on a broader question. But you talked about this dynamic in the quarter of HYDROS placement seeing a little bit of a slower ramp. It sounds like that probably impacted utilization. I have you on my initial update of the model here at low single digits increase in utilization. One, is that right? And then two, just talk about this dynamic. Is this something specific to HYDROS? And then what kind of changes did you guys make that are already showing improvements? And how do we think about that utilization number ticking back up to the normal kind of high single, low double-digit range that you've historically been seeing as you tackle this dynamic?

Yes. Thanks, Brandon. Let me take the math part of that equation. And you're correct. So if you look at this pure year-over-year growth in utilization in the third quarter, it is in the low single digits, but frankly, kind of right around our expectations and what our guidance implied heading into the back half of the year. And then you do see utilization in the fourth quarter guide kind of really step back up to more in line with where we're at with Q2. And that dynamic of HYDROS -- first off, a significant number of HYDROS systems we've sold in the last 2 quarters, coupled with an elongated launch time line has contributed to kind of that low single-digit utilization. And that's really the initiatives that we're focused on as a company.

Yes. I'll just add to that. We -- just in our natural capital cycle, a lot of our instrument placements happen late in the quarter when we close those sales. And I think that's true of most capital organizations. And what that means is we don't really get benefit from the units that we sell in that quarter. That benefit comes later. But we see a lot of variability in newly placed systems between the sale and between when they come online and when they start delivering real utilization. And that's just a huge opportunity for us to really tighten up, and that's been an area of focus for us. But I'm committed to really focusing on utilization. I mean we have to deliver on the capital side of things for sure. But increasing utilization, I think, is our #1 priority, and I think that also fuels future capital. So I see these 2 things as going hand in hand. And again, I think there's tremendous work that we need to do to drive utilization. And again, we have early initiatives on this that we're encouraged by, and we've made organizational changes to try to drive it, and we're going to continue to do that over the next several months. But getting systems placed and getting them active and hitting our utilization targets sooner is going to be really important to us longer term.

Okay. And maybe a higher-level picture as a follow-up. Larry, you had mentioned a little bit that your experience in building the TAVR market, I think you used the phrase of -- sorry, patient activation and some other learnings. And you were talking about moving kind of past the early adopters into the -- crossing the chasm here and going into the broad adoption. Talk a little bit about in TAVR, what did that take? And what isn't being done here in PROCEPT? What do you think within the PROCEPT story in your experience needs to be done? It feels like that's kind of the next step, as you had alluded to for PROCEPT is you've got a great technology, great clinical backing. How do you make this a technology for the masses?

Yes. No, it's a great question. I think one of the things that we saw in TAVR is if patients just were referred and they walked into a surgeon's office and they had aortic stenosis, the surgeon would just recommend surgery because that's the procedure that they can do. And frankly, it's a procedure that had a great contribution margin for the hospital, and they were happy to just keep doing that. And so when a patient walked in indifferent to the procedure that they're going to get, then the doctor might do what's easiest for them or what's most profitable for them and go down that road. I think bringing the patient's voice into that equation is really important. And I think also we generated a lot of evidence in the TAVR space to show why TAVR was a good procedure for these patients and in many cases, why it was a better procedure than surgery. And I think we need to spend more time focused on the evidence with the clinical community, so they understand these procedures aren't all created equal, and we can deliver differentiated results for patients. And at the same time, we need patients to be educated on what questions should they be asking their doctor to the degree that things like I only want to have one procedure, so I want the most complete outcome. There's just a lot of things that we need to do from an educational standpoint. But I think it's a complete game changer when a patient walks in and says, I've watched an Aquablation procedure and then the doctor has to try to change them to another procedure versus a patient just coming in and saying, what do you think I should have, whatever you recommend is what I'll go with. And there's just a lot of work there that we have to do, both with the medical community and patients. And then I think the other thing is we need to keep focusing on the evidence. We need to keep creating the evidence, and we need to keep amplifying that message so that people feel great about the procedure they're performing. They know they can deliver these great outcomes for patients. And I think that's really what our system can do in a very differentiated way. And right now, I think the doctors view a lot of these procedures as being very similar in terms of outcomes. And I don't think that's representative of what the data reflects, but that's on us to tell that story.

Our next question is from Richard Newitter from Truist Securities.

I wanted to start off with the '26 outlook. Thank you for providing a high-level revenue number. I was hoping you could provide maybe broad strokes on some level on the components. There's probably a lot of ways you can get to that number. So maybe whether it's commenting relative to where you see consensus, capital procedures, is there anything that needs to be kind of moved around? Or you kind of feel pretty good with the [ sum ] of the components as they are? And then also, if you could just talk about -- you mentioned the first half next year procedure, I think you had said procedures will be -- or utilization will be a little challenged. Is that -- why is that?

Yes, Rich. So there's a lot of puts and takes to the model, so I appreciate the question. And I'll start by saying we plan to provide a lot of color, obviously, in February when we introduce guidance. And I don't think there was anything out there we see modeling that is grossly misrepresented at this time, and our guidance essentially brackets where consensus stands today. I think the one thing I will say to maybe help frame is just with the international business, [ you see ], that's somewhere in the $45 million to $50 million range, and then you can kind of work the model backwards from there. But at this time, we're not going to get into the different components. We want to finish the year. We're focused on driving procedures in the business in the fourth quarter, and we'll provide an update in February.

I'll just add. As we mentioned that there could be some headwinds in the first half, we're not -- we don't want to be blind to the fact that we've made a lot of organizational changes, but I'm really committed to putting the right long-term organization in place that's going to drive our long-term growth and our long-term future. And I appreciate that, that's a transitional period, and we may see a little bit of headwind from that. But I remain super confident in the team and everything that I've seen, everybody is on board, everybody is committed to making these changes and driving the business, and we all think we're going in the right direction. But we just want to be respectful of that it is a lot of change for a lot of people in a short period of time. But that's all reflected in our guidance. And we're very comfortable with the guidance that we provided. And obviously, we're going to try to drive the business as hard as we can.

Okay. And then maybe if I can -- just on profitability. Look, it's 2 quarters in a row here where you guys are coming in above us or better than the Street's thinking. Kevin, can you talk a little bit about where you are on the trajectory to profitability? And then I guess, Larry, just -- should we expect anything in terms of reinvestment that's needed now that you've had some time to look at the business? And what should we be thinking about the profit trajectory and all the comments you provided before this leadership change, if any?

Yes. Maybe I'll start with it, and then I'll let Kevin pile on if there's -- if I miss anything. But there are going to be strategic investments that we make. But to some degree, I think it's going to be redirecting some of our spending to some of the new activities rather than just all incremental spending. But at the same time, I don't think anything is going to disrupt our path to profitability. But I will say this, just so it's clear to everyone. If there's an investment that I feel we need to make that's going to drive our long-term growth and that delayed profitability by a quarter, we would make that investment. I'm really -- I'm building a house to live in. I'm building a house that I plan on being here for a long time, and I'm really looking at how we build this to try to drive long-term growth and long-term value. And I don't want to become so obsessed with profitability that we miss out on critical investments even if those don't pay off for 2 or 3 quarters or for 4 quarters. So we're going to make those investments. But I don't think anything disrupts the path that we're on to profitability. And I think we're going to be responsible spenders of our money, but we're going to invest in the strategic priorities that are going to drive our long-term value.

Our next question is from Patrick Wood of Morgan Stanley.

Amazing. I'll keep it to one, but basically around the commercial activities and utilization side of things. I guess, correct me if I'm wrong, but there's basically 2 componentry here. There's a, as soon as the system is placed, getting faster off the blocks and getting some of that utilization right out the gate, but presumably, b, it's getting eventual total utilization higher. You mentioned you were putting some commercial activities in place. I'm just really curious, when you're addressing those 2 factors, can you give us some like specific flesh on the bones to sort of think about the changes that are being made? Is it just who's running what? Or is it incentive structure? Just any more details there would be amazing.

Yes. Thanks for your question. I think there's a few things there. I think, one, as I mentioned before, we want to see new systems, the metrics that we're building in is really from time of sale to hitting our utilization targets. And we want to minimize amount at a time [0:30:01.6], which is highly variable. And I just wouldn't say -- I would say, if I'm just real frank about it, that I think sometimes the handoff between our -- the capital sales team and the utilization team could be enhanced. And so that's become a big area of focus, and I think that will improve our utilization out of the gate. And that's not just the time to first procedures, but the time to doing a number of procedures that we would consider a system to be fully launched. I think the other thing is we've looked at our organization structure to say how do we best utilize our field resources. And I think there's a recognition that it's more than just being in cases. We have a lot of our field team that spends time in cases and they support physicians. And it's an important part of what we do because we want to make sure every patient has a spectacular outcome. But there's more to the role than that. And we need to be building the market and driving the cases and spending time in the office, spending time with referrers and doing all the other work to make sure people are up to date with the latest evidence and those sorts of things so that we're the preferred procedure for BPH. So it is asking our people to do a lot of things differently than what they've done historically. But I think that's what it's going to take if we're going to drive and improve our utilization over time. And again, it's -- I don't want to keep referring back to it. But this is very much the transition that we went through at Edwards. In the beginning, all we did was go and support cases, and it was sort of a, if you build it, they will come. Then you reach an inflection point where you have to start getting to the doctors that do multiple procedures or aren't those necessarily early adopters. And eventually, we're going to have to get to those entrenched physicians who are very comfortable doing what they're doing and maybe shy away from new technology. But each one of those tranches takes a different mindset and a different interaction with the customer. And I think we're just moving to the next phase of it. And again, I think the team has done a great job with early adopters, but we're just entering in the next phase, and it's just going to require us to do different things than what we've done historically.

Our next question is from Ryan

Larry, the utilization talk is music to my ears. I appreciate you harping on that. One of the questions I have, though, is there are some new PFS rates that just came out, and you guys got a Category I code. It's down in line with kind of the other procedures, about 550, if I'm not mistaken, on the code. But my question is just in light of that, how do you think that impacts utilization? And what underpins your confidence on procedure adoption given those dynamics, especially for '26?

Yes. Thanks for your question, Ryan. Honestly, I think the fees came in about what we expected them to. I think everything is in line. But that's really the smaller part of the economics. I mean the procedural reimbursement is a much larger part of that, and we're still waiting to see where that falls, but we remain cautiously optimistic that, that's going to land in a solid place. But I think the other thing, too, is economics are important when technology is all viewed as homogeneous. I think when technology is highly differentiated, I don't know that people are going to take better economics over a better procedure. And for those of you who -- I know several of you followed Edwards, in the early days of TAVR, I remember there's a lot of discussions [ which ] the contribution margin from open heart surgery is probably more than double the contribution margin from doing a TAVR. And there was a lot of people who thought that was going to be a massive headwind, and we've seen how that played out. We had a highly differentiated technology, and it became less about the contribution margin and it became more about the procedure and the efficiency of the procedure and the outcomes that we were driving for patients. So I think we need to make sure that people understand how differentiated our procedure is. But I think the economics behind our procedure certainly support the improved utilization and increased utilization that we expect to drive.

Okay. I got a lot of other questions. I'm going to just stick with one more, and then I'll save it for the follow-up for you guys. But as you think about guidance, Larry, I mean, the company has had a philosophy around guidance. I think the beats have been fairly formulaic relative to maybe expectations or kind of what the guidance has been. Do you have a different view on this in terms of how you're approaching? You talked about, obviously, your thought process for the '26 guide. But I guess, more in the context of how you think about it relative to the expectations or how you perform or maybe what your internal guidance is, et cetera. Just curious if you want to speak to that.

Yes. I don't know that I'd give you a very satisfying answer to be frank about it. I think my approach to guidance is we need to create a range that we're going to achieve. And I think we need to be accurate about it. And I think we need to have upside potential, but we also need to reflect realities and not everything may go exactly like we want. But to the degree that there's expectations out there, I'm not probably a big believer in moving guidance around in relation to expectations. I'm more a believer in driving the execution of the company and putting out good guidance and achieving or exceeding our guidance through improved execution. So that's kind of where I'm going to land on things, and we'll go. But I think it'd be unrealistic to think that I know everything about the business. Obviously, Kevin and Matt have been here a long time, and I rely heavily on them. I'm in my eighth week, and I suspect when we get to February, we can probably have a lot more fulsome discussions around guidance and how we see the long term and maybe some of the models that we have.

Our next question is from Chris Pasquale, Nephron Research.

Larry, this is a market where you have a lot of patients on the sidelines deferring care. You talked about the need to educate those patients. You talked about the company not really having told its story yet. I put all that together, and it sounds like an argument for an investment in DTC advertising, which some other companies in the sector have spent a lot of money on in recent years. Is that something that you're contemplating? And maybe talk about how you balance that drive toward profitability with maybe some spending priorities or some areas where the company may not have been investing enough historically.

Thanks, Chris. Well, I think there's a lot of different channels that you can use. And obviously, if we want to do a Super Bowl commercial, that gets very expensive. But I don't think you have to do that to go deliver your message to patients. I think, there's social media. There's a lot of other things that we can do that are pretty cost-effective ways to do things, and we did a lot of these things at Edwards. So I think these are all things that we're going to be focused on, but we do have to take our message to the patients. And we do have to get that out there to them so that they understand. I think one of the other things, and I know you followed Edwards, Chris, that there were a lot of patients that just believed that aortic stenosis was just all about symptoms tolerance. And there was not an understanding of the damage that was being done while they sat in that symptomatic phase until it became intolerable. I think the same is true of BPH. I think a lot of patients are sitting on the sidelines and they're just saying, well, it's just about whether I can tolerate these symptoms or not, but there's not a good understanding of the damage that they're doing to the bladder and the long-term complications that can lead to that point to a need for earlier therapy. And so again, I don't think any work has been done in that area to really tell that story or make that clear to patients. I think it's all just been focused purely on this procedure versus that procedure and a lot of early data. So when I say we got to tell our story, it's not just to the patient, some of it's to the clinicians, but there is going to be a direct-to-patient element of this that we will be investing in. But again, I don't think it fundamentally changes our path to profitability. I think that remains intact. And we'll just have to make responsible investments along the way.

That's helpful. And then I just -- I wanted to double-click on the comment about hospitals scrutinizing purchases more closely. You guys had a strong quarter for capital. Most of the other companies that get asked about this topic routinely have also said, look, things remain pretty healthy. So is there something new that you're seeing that you wanted to call out and really flag here because it could impact things going forward? Or are you just alluding to the fact that, look, it's been a tough year from a macro perspective in general, and you're continuing to execute despite that?

Yes. Thanks. I don't think it fundamentally changes our projections for capital. I think what we've seen is the purchasing process is taking longer. I think there were systems that we expected to close, for example, in Q2 that just got pushed into Q3 just because it just seemed like a lot of systems have put additional steps in place or they've expressed just some macro concerns and it's just caused things to be delayed. I think we generally expect -- and we saw that this quarter, the systems ended up showing up and they ended up coming through, and we continue to expect that to happen. It just seems like there's a few more steps being added to the process and things have just been moving a little slower. I think we just wanted to be transparent about that.

The next question is from Suraj Kalia from Oppenheimer & Company.

Larry, congrats on your new role. It's a pleasure to be working with you again. Hopefully, you can hear me all right.

I can.

Perfect. So Larry, I totally get your point about TAVR, the parallels there. If I could just expand on Chris' earlier question, Larry. So TAVR was a convincing solution for a high acuity condition, and we saw rapid share shifts, right, from SAVR. Specifically, as you look at BPH, do you think -- and as you lay out the long-term plan, the focus is specifically going to be on pulling in de novo patients, whether through DTC or otherwise? Or you envision this more in terms of share gains from TURP, nucleation, what have you?

Yes. Thanks for your question, and it's good to hear from you. It's nice to hear friendly voices. The -- I think the biggest opportunity we have is getting people off the sidelines. And I think even when I worked back in cardiac surgery, there were a lot of patients that viewed the cure is worse than the disease. And so people would avoid having open heart surgery even though they had a life-threatening condition that was damaging their quality of life. And I think we see that in the BPH space as well. You have people who -- they're so worried about the surgery and its impact on potentially leading to incontinence or potentially leading to sexual dysfunction. So they'd rather live with their symptoms than having cured. And I think what we need to be able to show people through our evidence is our incontinence rates are incredibly low, almost 0. And our sexual dysfunction rates are also incredibly low. And so you can correct your problem and actually markedly improve your quality of life. So the people suffering on the sidelines are by far and away the biggest opportunity. As we grow the market, we want to absolutely make sure we're getting our fair share. But to the degree that we can expand the market and that we can grow the market, that's more valuable to me than trying to move a share point from TURP over to Aquablation.

And for my follow-up, Larry, obviously, BPH is a lot more fragmented, right, versus severe symptomatic AS. How should we think about -- or what is your view in terms of the price elasticity of demand, i.e., should we think about the same approach where with the SAPIEN and SAPIEN 3 Ultra, you'll adopt it in terms of premium pricing versus rest of the market for Aquablation also? Or you'll think there would be a more flexible approach given the changing price elasticity of demand in BPH and a fragmented market? Congrats again.

Well, to the degree that you want to draw parallels with SAPIEN, I think I waited 15 years before I did a price increase. So I don't think price increases were a huge part of our development strategy. And I don't know that price increases are going to be a huge part of our strategy here either. It's funny when people say the aortic stenosis market was not very fragmented. I think that's a view today. That was not a view 15, 18, 20 years ago when we started working on it. I think it was highly fragmented, and you looked at high-risk people and intermediate risk people and low-risk people, and now we talked about asymptomatic. So again, it's not a perfect analogy by any means, but I do believe that there are a lot of parallels. And I do think the journey is going to be similar. Now to your point, we're going to continue to develop our platform. We're going to continue to innovate, and we're going to continue to make sure that we have the best therapy and the best technology, and it's also backed by the best evidence. And I think those are things that are just going to be hallmarks of what we do. But it's really going to be about getting patients off the sideline and improving our utilization rates.

[Operator Instructions] Our next question is from Nathan Treybeck from Wells Fargo.

Kevin, I think you disclosed one system placement under an operating lease. Can you talk about why this was done? And do you expect operating leases to become a bigger part of your system placements going forward and then just modeling considerations there?

Yes. Look, this was not an indicative or a shift in our business practice, but we did feel we owed an explanation given our installed base went up by 58 and we sold 57. So this robot is -- I would characterize it more as a one-off where we aren't able to recognize revenue. It's going to be paid for over time. But there is no near-term plan to have a significant shift in our business model. But as we've said in the past, the #1 priority is to get robots installed and to generate procedures and to treat patients, and we'll continue to evaluate various alternatives as they make sense for the business.

Okay. And just for my follow-up. So just based on my forecast, I guess, over 70% of your installed base next year will be with accounts that have been doing Aquablation procedures for over a year. So it seems to me that new accounts should be less of a drag on utilization growth. I guess how does this play out for your utilization outlook next year?

Yes. Look, I think a drag is a bit harsh, but I think our focus on launching accounts in a more timely and robust manner and the focus there should allow those new accounts to come up the curve faster and start contributing more meaningful to utilization sooner in 2026. So that's point one. And then point two, the other area of focus is driving utilization in our existing accounts. And as you pointed out now with the age of our installed base, that's a huge opportunity for us to drive procedure volumes and procedure revenue is focusing not only on new accounts, but on existing accounts doing more procedures as well. And we also are working on numerous initiatives to help that metric as well. So it's twofold.

[Operator Instructions] Our next question is from Mason Carrico from Stephens Inc.

On the variability in timing from system sales to first surgery beyond that initial delay, is there any meaningful difference in utilization once fully ramped in the accounts where there was a longer delay prior to the first surgery versus accounts that made the transition quickly? And then second, for the accounts that did have a longer delay, are there any commonalities between those accounts fundamentally? I mean, does that tend to be concentrated in low-volume hospitals, high-volume hospitals, academic centers, community hospitals, I guess, any additional detail you can give there?

Yes. Thanks for the question. I think every account is a little bit of a snowflake. And so I don't want to speak in gross generalities. I will say I don't think we've had the focus organizationally and what happens the day after the system sale. And I think now what we've done in our launch pilots is we have everybody focused on what happens day 1 and also a plan, not just to get the first case done, but to get the first 15 cases done, to get the first 20 cases done and really get people in a cadence of doing the cases and the routineness of it. And so I think it's just a bunch of renewed focus on that and putting the energy behind it so that we drive that. I do have a belief that if we get -- and this is a belief that's -- I can't necessarily back it with data, but it's just intuitive to me that if we get a system placed and they immediately start with a high cadence of cases, then we're just going to see better utilization out of that system over time than we will if we just sort of let the game come to us. So it really is just about us driving the system and driving the adoption of the procedure much more aggressively than maybe what we've done historically, where we just kind of let the doctors use the system as they see fit rather than having a real strategic plan for how we launch each system.

Our next question is from Joshua Jennings, TD Cowen.

Nice to be on the earnings call with you again, Larry. I wanted to -- and the rest of the team. I wanted to just ask about the concomitant BPH and localized prostate cancer scenario. And I mean it is a meaningful, I think, case volume opportunity. We've had some docs over the last 12, 18 months talk about using Aquablation for those patients. Has that started to factor into utilization levels at some centers or more than some centers? And is there any opportunity to capture real-world data from those cases if they're being done at a high enough clip?

Yes. Thanks, Josh, and it's good to hear a familiar voice. I will say that we're really focused on the BPH opportunity. BPH is undertreated, and I don't want to get people too distracted with cancer. Now that being said, I think cancer is just a natural adjacency for us. And I've had time with a number of our KOLs, and there's a lot of excitement about how this could transform prostate cancer, but we need to complete the trial. WATER IV is running. I think we're going to provide a full update on that in February of next year at the Analyst Day, and we can provide more insights on that, and it's a natural adjacency. But I look at something -- I look at that as blocks that build on top of our BPH story, not like the whole story. And so I think everything that is in front of us right now to grow this business and drive it is going to be built around BPH with prostate cancer being an add-on.

Our next question is from Mike Kratky from Leerink Partners.

This is Brett on for Mike. Congrats on the quarter. I just want to go back to ASP, primarily on the consumable side, just where -- how should we be thinking about the mix of HYDROS factoring into that $3,200 that we've been seeing in the last few quarters, particularly in '26? Is there any point where there's an inflection where the mix actually gets to a point where you can start to see some growth there?

Yes. So if you look at our installed base today and when we launched HYDROS, essentially every system sold since Q3 of '24 has been the HYDROS system. And we said HYDROS does carry the consumable component higher ASP than AquaBeam, I think somewhere in the low single digits. And our guide in '26, perhaps for your model, I'd be relatively conservative on price. We will get some upside as the mix shifts more heavily to HYDROS, but we're also not reliant on price increases to get to the guide that is in the model. But naturally, over time, you should see low single-digit price increases as the mix becomes more towards HYDROS.

Our next question is from Michael Sarcone from Jefferies.

Maybe one for Kevin. You talked about 4Q gross margin guide of around 63%. And I think you did call out $2 million from tariffs, but just wanted to know if there were any other factors that you would call out in terms of what's impacting gross margin for 4Q?

No. You said it. Our guide does incorporate about $2 million in tariff-related expense. That's about 200 basis points alone for Q4. So outside of tariffs, you'd be looking at somewhere in the mid-60s. And I'll just say our margins at this point, they'll continue to trend upwards. But at this stage of the company, even at 65% margins, this isn't a headwind or a hindrance to the company being profitable. And we feel that even at these levels with outsized revenue growth and manageable OpEx, that path to profitability still remains clear, and we're not dependent on margin expansion at this point to get there, but we're continuing to work at it obviously.

This will be our last question. And this question is from Travis Steed from BoA (sic) [ BofA ] Securities.

This is Stephanie Piazzola on for Travis. Just wanted to ask about the Q4 implied guidance. You beat Q3, but maintained the full year 2025 guide. And you talked about some of the recent trends and changes, but I just wanted to follow up on the Q4 guide and the key drivers of that lowered outlook in Q4.

Yes. So if you look at what our [ Q ] guide entails compared to previous guidance, we essentially have lowered the overall handpieces sold number by about 1,000 systems. And really, we mentioned destocking. We mentioned inventory optimization and a focus on launching accounts. And it's really that dynamic flushing through via handpieces sold in the fourth quarter. And we do look forward to giving our investors an update on the procedure side of the business in February '26. And we believe when you look at that metric, you'll find that there's not really a slowdown in the business, but we felt we needed to call out the handpiece dynamic that both Larry and I referred to in our script.

Yes. Just to add to what Kevin said, and I think this is just a little bit of a business maturity issue as we get larger is we haven't really been managing customer inventory by establishing par levels for each customer. So we have some customers that are probably not carrying enough inventory, and we certainly never want a customer to not be able to do a case because they don't have adequate inventory. But at the same time, we have other customers that are probably carrying too much inventory. And our initial look at this probably says there's probably more inventory in the field than what's needed. And so as we optimize those par levels, we may see a little bit of destocking. But we're focused on procedure growth, and that's what's going to drive the long-term health of the business. And I'm expecting that we're going to have a good procedure quarter in Q4, and that's going to be our focus on a go-forward basis.