Thanks everybody for joining today. I'd like to welcome you guys to the 2026 PROCEPT BioRobotics Analyst Day. Appreciate everybody's flexibility on being here today. I know that there were some challenges with weather on the East Coast and having to shift things around. Appreciate everybody for being here, and also those that are on the webcast, thank you as well. We'll be making forward-looking statements today, so please refer to those disclosures in the front of the presentation, and also be referencing non-GAAP measures, there are some appendices in the back that everyone can reference as well. With that, I'll like to bring Larry Wood on stage, PROCEPT BioRobotics' CEO.
Thanks, Matt. All right. Thank you, first of all... ... about the future and let you know why we remain excited about our opportunity, why we are excited about what our future looks like. We think it's really bright. It starts with the market opportunity. When you look at where we are, there's about 400,000 patients a year that have actually a procedure done on their prostate. We're only about 10% penetrated into that space. We have a lot of headroom to grab share without activating any patients. Without getting anybody off the sideline, we have the ability to grow and grow significantly. Beyond that, though, there's 8 million men who are seeking therapy for their BPH. They're on drugs, they're seeking therapy, they're not happy with their condition. They're looking for relief from their symptoms.
Over a million men stop taking their drugs each year because they're either not effective, or they don't like the side effects that their drugs give them. That's another rich opportunity beyond the 400,000 patients that are seeking treatment today. Beyond that, there's about 40 million people that are getting that have the condition as well that's gonna continue to feed the funnel as they continue to progress with the disease. It's a large, untreated population. The reason why so much of it is untreated is, frankly, people are concerned about the procedure as much, if not more, as they are their condition. Where do we stand in this armamentarium, and what is our strategy? We have a game-changing technology. We have a technology that can absolutely change the course of the disease for these patients.
We have all the clinical evidence that we need. We're no longer this brand-new procedure. I think that's something that we're all aligned on. What everybody needs to see from us is that we can execute in the field, we can drive share shift, and that we can grow our procedure volume. We have to become profitable. We have to have a clear path to profitability, and that's a key area of focus for us. Then we continue to advance the evidence and look for additional treatment that we can do, and I'll talk more about that as we go. In terms of where we are, we've treated more than 125,000 patients worldwide. Our global installed base is over 900 instruments.
Again, we have a good installed base. We continue to add to that installed base. One of the big things this year is January 1st, Category I reimbursement, which is a big milestone for us. It solidifies this. When we were Category III, there was more questions about reimbursement now. Those things have been removed from the narrative. We're really excited about what that is. I'm going to talk a little bit about the changes that we've made to the organization. They obviously impacted the Q4 revenue. I want to talk about why we made those changes and the impact of those, and why I believe those are gonna benefit us long term. They're foundational things for us to do.
If you look at handpiece pricing over the years, you can see where the handpiece pricing was, and it was very consistent. We were very flat over the time. When you look at where we were through the first three quarters, we actually saw a little bit of an uptick in pricing. That was pretty much driven by the increased mix of HYDROS versus AquaBeam. Our pricing was very stable when you looked at it, quarter-over-quarter, and you saw where we were. You also look at the handpiece volume compared to procedures, and we'd always been averaging about 115%-120%, and we were consistently within that range.
What we did in Q4 is when I reviewed the practice that we were doing of offering end-of-the-quarter volume discounts and incentives for people to stock, as our installed base continued to grow, that just became a bigger and bigger thing, and customers were very conditioned to just wait till the end of the quarter, negotiate an incentive or be offered an incentive. They would stock up, and they'd order a lot of inventory, and then they'd spend the next few months depleting that inventory down and repeating the cycle over and over again. It was causing very lumpy revenue, and we were doing things at a discount. When I reviewed that practice, I believed strongly that we were just discounting a product today that somebody would have paid full price for two weeks ago, their actual contracted price. We eliminated that practice.
We just said: "We're not going to do that anymore. We're not offering these sorts of end-of-quarter rebates," and we completely eradicated that. When we did that, it had a much bigger impact on customer ordering behaviors. If you remember on the Q3 call, I talked about inventory levels, I talked about target inventory levels, and my opinion was that there was more inventory in the field than needed to be there. That was just related to establishing par levels and people carrying the right amount of inventory. In my old world, I lived in a consignment world. Every account had a par level. When I came to PROCEPT, no accounts had par levels, and every customer was just managing their inventory on their own.
We established those par levels for sites, and we thought that would result in a reduction of about 1,000 units, which is what we signaled in Q3. This is a completely separate issue. This was an issue that was driving customer behavior because of the incentives that were being offered, but it was coming at a cost to our ASP. When I look at our path to profitability and when I look at the long-term health of the business, price matters. Our margins matter. That's gonna be the critical thing that's gonna drive our long-term profitability.
We eliminated that practice, and when we did that, we saw an immediate boost to our ASP, but we saw a change to ordering patterns where people said: "Hey, if I'm not incentivized to overstock, I'm not gonna overstock." They took their inventories down to whatever their targeted inventory level was. When we look at that for 2026, we're now anticipating that handpiece sales and procedures are gonna pretty much fly in formation. Those numbers are gonna mirror each other, and the ASP is gonna go up to about $3,500. About a $300 price increase from historical to where we're gonna go this year, which is very meaningful for us, and I think it bodes well for, again, for our long-term health.
There were a lot of questions about this one-to-one. There's a lot of questions where people are like: "Yeah, but is there still inventory? Could there still be a drawdown? Are you sure this is all behind you?" Here's what I can tell you. What I can tell you is, when we look back over the last, multiple weeks since we instituted these changes in December, we've seen procedures and handpiece sales pretty much mirroring each other and flying in formation. If there was more inventory to draw down once the incentives were to be removed, I think we would've seen that over the last six, eight weeks, and we haven't seen that, which gives us confidence that we're on that.
Even beyond that, though, we are saying that inventory is going to be flat in the field, but we're still gonna add 200+ systems into the field next year, and all of those systems are gonna have to take a stocking order, and they're gonna have to take inventory. If people are at their proper inventory level now, and we added those 200 systems, inventory levels would have to go up in the field. This 100% ratio wouldn't actually work. It would have to be higher than that. There's no value in us right now modeling something higher than that, so we've modeled it at a one-to-one, which we think is a conservative way to model it, but I believe there's probably more upside than downside to that.
Given everything that's happened, I don't think there's any point in us being aggressive about that or modeling anything in higher than that. This is the biggest factor in the change of our guidance year-over-year. If we would've modeled handpiece sales to remain at 110% or 115% of procedure volumes in 2026, like it's been historically, that was worth between $20 million-$30 million. When we adjust the guidance, that's the biggest factor that changes our year-over-year guidance. We offset a chunk of that, a big chunk of it, with our pricing increase, but we don't offset all of it over our pricing increase, and so that's the biggest change that we have in guidance.
The other thing that we've talked about is our change to our sales organization and the process of that and why we made these changes. I'll talk through historically what we had. Historically, what we had was basically three groups: We had our clinical procedure support group, we had our sales support group, and we had our capital team. All of these groups were led by separate management. They all had their own incentives, they all had their own goals, and they were all sort of ran independently. What that meant was they weren't necessarily integrated, and they weren't necessarily aligned, and they didn't share a common goal set. I think that led to some disconnects in our business that didn't optimize our performance.
When we looked at that, we said, "Hey, the first thing that we gotta go after is the clinical support team and the sales support team." We had people going out, supporting cases, doing training, then we had salespeople that were trying to, you know, move share and trying to do those things, but they weren't doing it in a coordinated effort. We went out and said, "Not the best way to do that." We integrated these now to where we have a single regional leader. The clinical resources and the sales resources all report up to that common person. That regional leader can direct all of the resources in that region to optimize. If there's a site that needs more training, they can do that.
If there's a site that says, "Hey, you know, we need some help with the referral patterns and making sure that our referrers are educated so that we can get more patients in, and we can get them to Aquablation," we have our sales support team that can do that, but we can optimize those teams and make sure they're directed. That's some of the biggest changes that we've made. We also made changes on the capital team as it relates to launches. Here's what used to happen, are we had our procedure utilization team, and that was the clinical group, and we had the sales group. When a new system would come into a region, the utilization team had the dual focus of they had to manage their installed base, but then they also had to accommodate these new system launches.
They were sort of pulled in two different directions. Managing an installed base and trying to grow it is a very different skill set than launching a brand-new system and making sure people are trained, making sure people understand how to do the procedure. The other thing about it is, the capital team's job is to sell capital. When they would close a PO, oftentimes, the utilization team didn't even know that an instrument was sold or that was coming, and that's when the process would start. I would say in the early days of the company, there was probably already somebody waiting on the other side of this.
As the company has grown, and we're in big IDNs and other things, a lot of times an IDN will just say, "Hey, we want another system," or, "We want another couple of systems to put in our network so we can offer this therapy." There needs to be a champion at that hospital. There needs to be somebody to catch it. We've moved launch teams under our capital team. The capital team has the relationship with the hospital. The capital team has the most visibility into when that PO is gonna close. When we get close to that PO, they're the ones that can say, "Who's gonna be the champion at that site? Who's gonna be accepting this?" Start the screening process: "Let's get some patients lined up.
Let's get procedures lined up." We ran a pilot on this late last year. When we ran that pilot, we saw significant benefits from this new model. This is gonna change. I think procedures are what's gonna drive capital. Now, rather than have this be these handoffs, we have actually an integrated system. When we ran the pilot last year, we saw a 50% reduction in time from the PO to them completing their first 10 cases. That's the metric that we operate in. It's not time to first case. I think we had a lot of examples where somebody would get a new robot, somebody would do one case, they'd take a picture, they'd post it on LinkedIn. It might be weeks before they do their next case. That is not a strategy.
This is something I learned deeply when I was at Edwards, and we were doing the TAVR launch. Many of you followed Edwards. Many of you followed the TAVR program. One of the things that we learned is, when we launched a center, and they got into an immediate cadence of doing two cases a week, they got through the learning curve very quickly, they got their patient referrals, and they became a very healthy center, and they tended to stay healthy. If we had a center that launched poorly, they did one case, they went two or three weeks before they did their next case. They were slower through the learning curve, they tended to have more complications, and they tended to be a slower program that almost had to be relaunched at some point in the future.
I don't want to be in the business of relaunching programs. I want to be in the business of launching things, launching them with excellence, and having them work well. The challenge with that is, we took some of our most tenured people, some of our most experienced trainers, some of our most experienced clinical people, and we moved them from the procedure team over to the launch team under capital, so that they can make sure every new system we launch, launches with excellence and they launch in great health. The challenge with that is, now we have to go backfill those resources on our procedure team.
The other thing is, by doing this realignment to the regional system, not everybody is covering the same accounts they used to cover. There's new relationships that have to be established and new things that have to be done. These are not unusual. They are transient things. They're things that I dealt with throughout my career. As TAVR grew at Edwards, we were continually splitting territories. That meant people were getting new representatives, maybe new clinical specialists. They had to rebuild those relationships and start those. It's nothing unusual. It is something that does cause disruption, and when you're doing it just onesies and twosies here and there, it's not very disruptive, and it kind of gets buried in the big numbers. We made a massive shift this time. We realigned all of our territories.
We had a lot of people that have new managers, we have a lot of people that have new accounts, that is just going to take a little bit of time for it to mature. It's not a structural challenge thing. It's not gonna be a forever headwind. It's just something that's gonna be a headwind. We signaled that in Q1, in the back half of the year, we expect this to pay major benefits to us and drive this. As it relates to the capital side, the overwhelming majority of our systems are gonna be greenfield placements. I think we plan to do about the same number of greenfield placements in 2026 as we did in 2025. What's new, though, is we're going to go for a more targeted replacement strategy.
Historically, I think the company talked about replacements prior to me joining in this role, but there was just sort of a sense that replacements would happen organically. People would just say, "Hey, we wanna upgrade our AquaBeam, and we just wanna move to HYDROS. It's better technology. We just want to do that." We didn't really see that happening, as people hadn't fully depreciated their systems. The AquaBeam system still is fully functional. People are using it. It just wasn't something that people were just organically gonna go do. We have to be much more purposeful about how we do that. The way that we're gonna do that is we're gonna work closely with our customers. One of the things we'll do is, based on the age of their system, we will offer them a trade-in credit.
We'll offer them a trade-in credit, which will be an incentive for them to upgrade. As these systems get older and they're depreciated off the books, we think there's gonna be an attractive replacement cycle that we're going to be able to work closely with our customers and incentivize them. We do believe that as customers upgrade to a HYDROS system, we have data on this that says, our utilization is better with HYDROS than it is on AquaBeam, and so we think that's gonna be a benefit to us. The other thing is, at some point, we will sunset the original legacy AquaBeam system, and we wanna make sure we convert that installed base over to HYDROS before we end up sunsetting that platform. That's a lot of the work that we're gonna do.
The last thing is, we're gonna start exploring leasing pilot programs. I don't think that's gonna be a big part of our 2026, but there are some customers that just don't want to make the capital expenditure, and if we can improve our installed base by creating leasing programs that are still very favorable for us and they work for us economically, we think that's another opportunity for us to drive procedure growth. We wanna make sure we pilot those things well. We wanna make sure we understand how they work, and we wanna make sure they're delivering on the economics that we need and the procedure growth that we need. Those are some things that we have to work out.
Again, overwhelmingly, it's gonna be greenfield placements, but we are going to begin doing replacements, and we are gonna explore the leasing, and that's where we're headed strategically. What it really comes down to is the clinical case for Aquablation versus the competitive therapies. I will say, we have more evidence in, on our technology than anybody else has in our space. We have best-in-class evidence. We spent more money, probably, on research and high-quality trials and registries to understand how our technology works. If you look at how we've been performing against other modern surgical treatments for BPH, you can see how much we've grown, and you can see, the other procedures are more or less declining, and we're taking share, and we are growing, and we're really expect to be the leading procedure amongst these modern therapies in 2026.
Our next opportunity is really gonna be going after TURP. TURP is literally a 100-year-old procedure. It hasn't really changed that much. It's been out there for a very long time. We believe that we have a meaningful advancement over TURP. We have a lot more precision that we can bring to the table. We have a lot more repeatability that we can bring to the table. This is the place that we need to go move share. Again, we're only about 10% penetrated into this space. Converting share from TURP is a huge opportunity for us. Here's what it really comes down to when I talk about making the clinical case. We talk about all these patients on the sideline that aren't pursuing therapy and the why is that. Well, here's the choice that patients have.
They can say, "I'm going to do one of these resective procedures, you know what? I can get a lot of symptom relief, I'm gonna deal with a lot of complications. Complications that are very meaningful for men, incontinence and erectile dysfunction. Those are two things that men absolutely do not want, in some cases, men feel the cure is worse than the disease they have, they're gonna sit on the sideline and wait. They're gonna try everything they can to delay that therapy. That's the problem if they go with a resective procedure. If they do a non-resective procedure, they can preserve their sexual function and their urinary function, the procedure doesn't work very well, it's not very durable, they don't get much symptom relief.
They're sort of left with, do I have something that doesn't really solve my problem very well, or do I have something that solves my problem but leaves me with side effects and complications that I absolutely don't want? This is where we're unique. We can offer the protection of urinary and sexual function of a non-resective procedure with the symptom relief of a resective procedure. This is the case that we need to take to patients, and we need to take clinicians, and that we have to make. This is something, quite frankly, we have not done. I will say, when I joined the company, if I impersonated a BPH patient, and I went online, and I wanted to see how easy was it for me to get directed to Aquablation as a therapy, the answer was: it was virtually impossible.
We following systems and having physicians like the therapy, and then drive patients to the therapy. It hasn't been driven by patients or by awareness or by any of these other things, and that's the case that we have to make. Pooja Sharma is gonna talk in a little bit. Super excited for you guys to hear what she has to say. She was with me for 20 years at Edwards and was a key part of the growth that we did in TAVR and all of the work that we did there. We're excited for what we can do to inform patients in the medical community. Here's the struggle that I think patients have and the mindset that clinicians bring to the table when they're treating BPH, and this is really a fundamental issue. They're gonna start with medical management.
They're gonna start with drug therapy. I think that makes sense. If you could take a pill and it solved your problem, everybody would rather do that than have some invasive procedure. I think that makes sense. The struggle is what the next step is. In the clinician's mind, they almost have this hierarchy of less invasive to more invasive in their mind. They say, "Hey, the least invasive thing I can do would be a non-resective procedure, so maybe I'll do a UroLift or I'll do some other procedure." If that doesn't work, or it turns out not to be very durable, then maybe I'll move to a resective procedure. They're perfectly comfortable with this concept of a patient having multiple procedures over their treatment course.
That might work really, really well for the physician, but it's actually not what matters most to the patient. When you do patient-centric research and you look at what matters most to patients, here's what matters most: The number one thing is they want to protect their urinary function. That is the most critical thing to them, and I think that makes sense. The number two thing, minimizing the need for a second procedure. Patients do not wanna have a second procedure. This is where what patients want runs in direct conflict with the physician treatment algorithm that they're running today. After that, they want symptom relief, and they want to protect their sexual function. It all makes perfect sense from a patient lens, but they want to have one procedure, and they want it to solve it.
This whole idea of less invasive versus more invasive, I will ask, once you have the sternotomy, the invasiveness feels exactly the same. I think the number of times that a patient should have a 24 French device go through their urethra is zero or one, and patients deserve to have the best procedure that's gonna give them the most opportunity to solve their problem and solve it the very first time. That is not the hierarchy that's being run today for the majority of these patients that are coming through. I know. Look, we have plenty of time for Q&A today, and there's gonna be a lot of challenges about our ability to grow procedures and do these sorts of things.
I totally get it, especially after we announced earnings yesterday, and people are running their procedure models and all of those things. This is the case that we have to make, and we have to take this to patients and clinicians. We do not have a fundamental problem in this business. We do not have a foundational problem in this business. When you go out and survey doctors, if doctors were telling you, "I don't think Aquablation is a very good procedure for my patients, I don't think I get good results with this, and this is why I'm moving to other procedures or doing something different," I don't believe that's what you're hearing, and it's certainly not what I'm hearing.
What I hear is, "The economics of this procedure are better," or, "I can do this procedure in office," or, "This procedure is cheaper for me to do," or something like that. Those are things that do not matter to patients. In my entire 40-year career at Edwards, I never met one single patient that said, "You're not gonna believe the deal my hospital got on my heart valve." We have to make sure that patients are getting treated by what matters to them most. I will tell you, many of you wrote notes on TAVR back in the day, and one of the things that got in everybody's notes was, TAVR is going to have a headwind because the economics of cardiac surgery are better than the economics of TAVR. Hospitals make twice as much money doing open-heart surgery as they do of doing TAVR.
They're gonna use TAVR as a loss leader, and they're gonna convert all their patients to open-heart surgery. Remember those notes? The choice for hospitals wasn't whether they were gonna make $20,000 or whether they were gonna make $10,000. The choice for hospitals became: Are you gonna make $10,000, or are you gonna make zero? Because patients weren't indifferent to getting cardiac surgery versus getting TAVR. If they went to a hospital, and the hospital said, "Yeah, we don't wanna do TAVR on you; we wanna do surgery," the patient said, "Thank you very much." They got up and left and went to another hospital to find a place that they could get TAVR. We need to create that same dynamic for Aquablation in the treatment of BPH, and that's our job. That's what we have to go do.
When you look at what matters most to patients in that value proposition, it isn't about having it done in office, and they do not care what the economics are for the clinician. They want their problem solved. They want it solved the first time. They want maximum relief of their symptoms, and they want to make sure their urinary and sexual function's preserved. When you look at the world through that lens, nothing competes with our technology. You look at the durability of our procedure, this one-and-done aspect. Here's the data. I know there's a lot of questions about PAE. PAE, the economics may be great. The durability of the procedure is not.
When you look at the other competitive therapies that we have, the reason a lot of the therapies kinda show up with a lot of fanfare, and they kinda drift away over time, it's because they do not fulfill their durability promise. I will tell you, a significant number of procedures we do are redos for patients that have had a UroLift procedure. I've been in those cases, and yes, we can redo them, but having a UroLift before getting an Aquablation does not make the Aquablation procedure easier. Like, we are continuing to invest in evidence and continuing to invest in the technology. Our system is highly differentiated. We use AI to map the prostate. We create an overlay of what the procedure should be.
The doctor can customize that overlay to do exactly the procedure that he wants to do, and then the robot delivers the precision to ensure that that procedure is done exactly as the clinician designed it, with precision and repeatability that the other procedures simply do not offer. When people are trained on this properly and they use our technology, it delivers differentiated outcomes very safely. When you look at what we have ahead of us, we expect HYDROS this year to become the majority of our installed base, so we'll cross that this year. We're starting a global expansion. We're gonna spend a little bit more time thinking OUS than we've done historically. We have launched HYDROS already in the U.K., and we'll continue to launch HYDROS outside the U.S. this year.
We continue to invest in new indications and other things that we think are gonna be very meaningful for us. I do think international is a bit of an untapped opportunity for us that I don't think it's a huge part of our story in terms of 2026, but I think in 2027 and beyond, international will play a larger and larger role in our study. The next frontier for us: cancer. I will say it is very rare to have an opportunity that we have that's as large as prostate cancer, that's an adjacency for us, that is done at almost 100% leverage. It leverages our exact system, it leverages our exact handpiece, it leverages our training, and it leverages our channel. It's a whole new opportunity that really bolts on to everything that we've done.
As it relates to prostate cancer, again, it feels very familiar to me than what I dealt with when I was doing TAVR. You had patients that had heart disease, they had severe aortic stenosis. The procedure was open heart surgery, and even though that's an excellent procedure, if you go to a good hospital, and you have your aortic valve replaced, and you're a low-risk patient, you have about a 99% chance of having a really great outcome. The collateral damage that gets done to the body during that procedure was something that made people not want. People would delay that therapy as long as possible. They'd wait till their symptoms got severe, and then eventually they would have the procedure done. Nobody wanted to have open heart surgery.
When we developed a catheter-based therapy and people could have the procedure, we didn't do all that collateral damage. It was an absolute game changer in the treatment of valvular heart disease. The last trial that I ran before I left Edwards was for asymptomatic patients. The word actually is watchful waiting. It is the fastest growing segment. A person is diagnosed with prostate cancer, they have cancer in their body, but when faced with the treatment options that exist for them today, they'd rather do nothing than have the procedure, and they just hope and pray every day that they're a slow progressor. That is the option that is in front of them. Nobody wants to have cancer in their body. People would rather have it taken out.
I will say, in open heart surgery, it's actually a little bit of an irrational fear when you look at the data, because great outcomes. Here, it's not an irrational fear. For men who have radical prostatectomy for the treatment of prostate cancer, the majority of men, the majority, end up with severe erectile dysfunction, and 25%-33% end up with urinary incontinence a year. These are serious complications that no one wants, and so they would rather live with the cancer in their body and just keep an eye on it than have this therapy with those kinds of outcomes. The thing about it is, 60% of them are gonna end up getting a radical prostatectomy anyway. This is where we believe we can change the treatment modality here, and we can make a huge difference. We have Barry here today.
He's the Sun King as it relates to all things technology and the WATER IV trial and what we're doing in cancer. He's gonna bring that to life for everybody, and you're gonna see what the opportunity really looks like and why we're so bullish on our therapy being able to play a meaningful role in the treatment of prostate cancer. We have multiple initiatives. We have a lot of opportunities to grow. It all comes down to our ability to execute. We're only about 10% penetrated into the patient population today that is already seeking a therapy. We believe we can make a meaningful difference there. There's a group of patients above that.
The first group that we go after that is the 1.1 million men who have given up on their drug therapy. They've already sought therapy for their BPH. We believe that's another group of patients that we can go after. We have to educate patients. We have to create the value proposition for them to where they're coming in, and they know what procedure they want, and they understand why our procedure is the best procedure for them, for the things that matter most to them. Beyond that, we have the opportunity with prostate cancer that I think could provide meaningful growth for us as that data comes out from the WATER IV trial, assuming, of course, that it's a successful trial.
Those are the things, that's our strategy, that's what we're trying to do, and what we're committed doing in terms of trying to enter this company in the next chapter and to grow and deliver on the expectations that we have for ourselves. With that, I'd really want to bring to life how we're going to do that. With that, I'd like to invite my good friend, Pooja Sharma, to the stage.
Thank you so much, Larry. It's a pleasure to be here. Larry and I are good friends indeed. We have known each other, as he said, for almost 20 years. I was with Edwards for almost 20 years within the transcatheter heart valve business unit and had the opportunity to sit on Larry's spectacular leadership team there as we worked to transform care for structural heart patients. I joined PROCEPT three months ago. I am very energized to be here and for the opportunity to transform care in the urology space. What I'm gonna do is, you know, you heard a lot from Larry on our three critical pillars for the next chapter. What are our big strategic focus areas? One is accelerating procedure growth, two is driving our path to profitability, the third is around advancing evidence and innovation.
I'm gonna get into a little bit more detail around from a marketing perspective, specifically as we talk about accelerating procedure growth. How do we want to go after share capture, specifically with our strong clinical differentiation, as well as I know a topic many of you have been interested in around how are we planning to approach targeted and disciplined patient education and engagement? I'll cover both of those things. This is an important time to invest in these marketing initiatives because, you know, the therapy of Aquablation is now established. We have over 125,000 patients that have been treated worldwide with Aquablation, over 900 robotic systems in our install base, and as of, you know, only 45 days ago, we have Category I reimbursement.
The technology and the therapy is also backed by a large, mature, maturing clinical body of evidence, I'm gonna talk a lot about that. It really starts before we get into targeted and disciplined patient education and engagement, it really starts with making sure that we're intentionally building belief of care teams as it relates to Aquablation. This reflects a lot of lessons that Larry and I learned in TAVR around sequencing. First, you have to establish the therapy, and that's, you know, the amazing work that the team at PROCEPT has done to establish Aquablation as a therapy. You need to drive that therapy as to the procedure of choice, targeted patient education efforts, if done strategically, they act as an accelerant.
Patients need to encounter physicians and care teams that believe in that differentiation of Aquablation. Let's start with the immediate opportunity, which is around share. You've heard a lot, you know, we're 10% penetrated as of the end of 2025. We're 10% penetrated into a 400,000 patient surgical market, both resective and non-resective procedures. When you look through the lens of what patients want, and you're grounded in the lens of what patients want from their therapy, Aquablation really delivers a complete solution, and again, that is supported by a maturing body of evidence. Our job from a marketing perspective is to position the technology clearly, succinctly, and in a compelling way, and educate care teams as well as patients around what that positioning and what that narrative looks like.
Here's what we're really standardizing as a narrative. Number one, Aquablation delivers complete symptom relief. I'm gonna talk a little bit about the most contemporary data in that area. Number two, patients want preserved sexual and urinary function, so we're gonna look at what the latest data is in that area. Number three, they want one procedure only. Durability is a big deal, especially in this space. Again, from a marketing perspective, our positioning is now around Aquablation as a complete solution for BPH patients through the lens of what patients truly want. Let's look at the data itself. As it relates to symptom relief, whether you look across a randomized controlled trial, real-world evidence, meta-analyses, you see consistency in those outcomes. Significant symptom reduction, of course, as measured by the IPSS score.
There's another area here that many of you may be familiar with, but we're gonna continue to amplify, which is around post-void residual results. PVR is essentially a measurement of the amount of urine that's left in the bladder after voiding. BPH, in particular, creates this chronic obstruction that forces the bladder to work harder and harder over time, and over a long period of time, can impair bladder function. What PVR matters, because lower rates of PVR mean better bladder emptying, and reduced stress on the bladder, reduced risk of infection. Aquablation, as a resective treatment, obviously, it removes the obstruction. This is an area where, with around symptom relief for IPSS as well as PVR, that we are going to continue to educate care teams on the most contemporary data.
Patients don't often understand the correlation between their obstruction as well as what's happening with the bladder. This is an area that we will focus as we talk about our message on complete symptom relief. The unique thing about Aquablation, though, is that symptom relief is not specific to a size of a prostate. There is now data that symptom relief is sustained, first of all, over time, but also, you deliver that symptom relief regardless of prostate size and regardless of prostate shape. That's very compelling. Now, patients want that symptom relief, but they want it without the trade-offs. They want it without the compromise. We see a less than 1% rate of incontinence and a less than 1% rate of ED with Aquablation.
Based on this data across 70,000 patients, real-world evidence that was just recently published, we have a less than 1% transfusion rate. That is even lower than the reference gold standard, legacy gold standard of TURP. We're delivering the symptom relief, and we're doing it without the compromise. The third key area in this complete solution is around durability. First of all, we now have two studies out to five years that demonstrate a 1%, approximately 1% annual retreatment rate with Aquablation. Just Aquablation, as it stands on its own, we now have five-year data with a 1% rate of retreatment annually out to five years. We also now have contemporary data that compares the therapies.
You can, you know, obviously see here that Aquablation delivers durability that is very comparable to the reference standard of TURP. You know, Larry had mentioned this, but many contemporary BPH procedures have really struggled to maintain momentum in the market because they may deliver on one out of three of the areas around complete symptom relief or maybe two, complete symptom relief, preserved sexual and urinary function, and durability, but none of them deliver on all three, which is why our positioning of Aquablation as the complete solution becomes important. The other piece is that, in particular, history shows that therapies that don't have strong long-term durability tend to plateau in the market.
Durability is an area where we will be amplifying our message and our narrative around, and we feel, you know, really confident, especially because the data supports the positioning. The question is, okay, if the clinical differentiation is so good, you know, why is Aquablation penetration into the surgical market 10%? I asked the same question before I joined just a few months ago. From a marketing perspective, there are a couple of barriers that we need to address. One is that there is a misalignment in the assumption of what physicians think patients want out of their BPH therapy and what patients want. This has been continuously now highlighted in the research, that there is a misalignment between those two things.
The second piece, obviously, is surgeons have comfort with legacy procedures, particularly TURP, and we have a really strong opportunity to differentiate against TURP in particular. We actually see both of these as opportunities, but also responsibility to educate care teams as well as, of course, patients around. I talked you through the data around Aquablation. You know, now we're gonna be much bolder about how we position Aquablation therapy against other competitive procedures, both resective and non-resective. As Larry mentioned, we have a strong opportunity against TURP. First of all, there's a lot of headroom with regards to share capture with TURP being such a long-term legacy procedure, and we also have strong clinical differentiation in TURP, especially across sexual function.
When you combine our clinical differentiation with the precision and personalization through AI-guided ultrasound that is under the surgeon's control, they get better OR efficiency, better throughput, you know, reduced variability across procedures, and you combine that with the Category I reimbursement that we now have as of 45 days ago, there's both a clinical value proposition and an economic value proposition. Patients win, clinicians win, and the healthcare system wins as well. You know, the first piece that we are focused on right now is standardizing that narrative, being clear with that positioning, being clear about what the clinical differentiation is, and standardizing that narrative. The other piece that's very important, and we've learned these lessons through our previous life, is to be able to operationalize that message.
We are investing much more in, you know, clear selling tools, clear competitive selling tools, clear educational tools for the care teams. We've packaged some of these research insights, a glimpse of what you got today during Larry's presentation around: "What do patients want?" It really helps open the door for educational conversations with clinicians, as well as care teams on the whole. We are investing in much stronger peer-to-peer education programs, really activating the KOLs that believe so deeply in this therapy. How do we, you know, incorporate them into the training pathway on a local level, through case observation, but also through broader webinars and broader educational events?
Beyond the misalignment between the assumptions of what physicians think patients want and what patients want, plus surgeon comfort with legacy procedures, there's a third barrier here that we have the opportunity to address from a marketing perspective, which is low patient awareness of Aquablation. Our research also tells us that right now, the unaided awareness for a BPH patient of Aquablation therapy is 1% - 2%, for obvious reasons, because PROCEPT has not historically invested in this area. But we want to invest in the area in a very targeted and very disciplined way. It starts with patients who are at the bottom of the funnel. It starts with patients who are actually trying to make a decision between surgical therapies, and that's where we start.
It's really important that those patients encounter care teams that believe in the differentiation of Aquablation, but we also want to be very targeted and disciplined about our efforts of: how do we go educate patients? It starts at that bottom of the funnel, and, you know, our approach right now is to actually build programs with in-practice education tools, treatment comparison guides, videos for consult rooms. Patient testimonials is something that is very effective in healthcare. They want to hear from other patients. That's very important, especially as you're trying to balance and make these decisions between surgical therapies. Again, our disciplined approach to patient education starts at the bottom of the funnel. Of course, there is a lot of opportunity mid-funnel. There are over eight million men who are currently managed or have been managed on medication.
The unfortunate thing is that over one million of them actually discontinue medication and start watchful waiting. It's not surprising because the medications for BPH are not necessarily benign. When you have these categories of alpha blockers or 5-ARIs, they have near-term side effects: fatigue, dizziness, sexual function. That sexual function side effects, they sometimes, you know, increase over the long term. A lot of these patients are actually on combination therapies, and what happens in the data with combination therapies is you get the best of both side effects, right? A lot of these patients, unfortunately, the medication, one, is not effective, so they do combo therapies. There's also some contemporary, excuse me.
There's also some contemporary literature and studies that are suggesting now that long-term use of BPH medications also can negatively affect mental and psychological effects, dementia, depression. The drugs are not benign. There are a lot of patients who are incredibly frustrated with being on BPH medication, who are actively searching for solutions, but they're in that exploration phase, and that's an important target of the population that we do need to address. When we're looking at that mid-funnel opportunity, this is about educating those patients that are probably already frustrated with their medication, and they're under existing urologic care. In that area, our approach becomes digital engagement does play a big and effective role in this area, social media, search engine optimization, educational emails, but being thoughtful about how we target geographically those types of programs.
We don't need to go do broad national spend. It's really about targeting those types of programs and making sure we educate patients who are at that point in the journey. One of the reasons why this is, we believe this is going to be effective is that, of course, increasingly, patients take a strong, a strong role in healthcare. In urology, in particular, and with BPH, actually, in particular, the research actually supports that they take a particularly strong role in their care. We see that over 20%, well over 20% of patients will actually request a specific BPH procedure by name. Again, for BPH, in particular, over 70% of urologists, self-reported by urologists in the research, actually say that they will strongly consider patient requests if they believe that the therapies offers the right efficacy.
We do believe that this is an important part that we need to begin investing in, and again, we're going to do it in a very targeted and very disciplined way. Long term, after our conversion pathways are proven, then, of course, we can go much more broadly and address these 40 million men as a whole, and that looks like broader national awareness campaigns, but that's much further down the road. Right now, we want to focus on the patients that are at the bottom of the funnel and then move systematically through that. You know, again, Larry has shown, you know, our strategy is really near term around driving procedure growth through improved execution. From a marketing perspective, we're standardizing our narrative now. We're being very clear about how we are positioning the therapy.
We are operationalizing that narrative through the field, but we're also starting with patients mid-funnel, that waiting is not winning. Figure out, you know, how do we do that again in a really targeted way, and there's a lot of efforts that we have going on to make sure that we do that effectively. Then, of course, you know, expanding the applications around prostate cancer. This engine that we think we can build from a marketing perspective and the infrastructure around BPH, that engine is gonna be important because along with Larry's comments around leveraging technology and the commercial sales channel, we can also leverage some of this marketing infrastructure as we expand applications, potentially to prostate cancer in the future. I know that was a glimpse into our efforts.
Again, I'm very excited to be here. I'm excited about our opportunity in the future, and with that, I have the pleasure of introducing my new good friend, Barry Templin, who's the Chief Technology Officer, and he'll talk to you a little bit more about prostate cancer.
All right. Thank you, Pooja. All right, good morning. My name is Barry Templin. I came to PROCEPT 10 years ago. I've got a little bit of time on both Larry and Pooja, I'm excited to share a little bit of a glimpse into the future here around prostate cancer and where it's gonna fit in our program as we move forward. There was a critical decision that we had to make as we embarked on this a little over four years ago, which was, we had two doors. Door number one, whole gland treatment. Door number two, focal treatment, where you aim for the disease, hemigland ablation. Why does this matter? First, you have to understand the disease. There was a study done at UCLA that was published a number of years ago.
They went back, they looked at their radical prostatectomy population, and they filtered it out as if their baseline condition would set them up for what today you would choose for focal therapy. Smaller glands, less than 60, PSA, less than radical. They take the gland out, they do a whole mount , and under a microscope, they look to see, is there any other disease in that gland? What they found was that for over 40% of those men had contralateral, meaning disease on the other side that was not seen by MRI, and it was missed by biopsy. With this information out there, we have chosen to be a whole gland treatment because a patient cares that they don't want cancer in their body anymore.
They don't care, like, oh, you can see it on a lesion, but what about the disease that you can't see? This has embarked our clinical program and our path as we've gone forward. Door number one, whole gland. Door number two, focal. We, as a company, are using our technology for whole gland treatment because we want to treat the cancer as broadly as we can, which is why radical prostatectomy is the gold standard as to efficacy. Okay, so for four years, we have done a number of clinical studies, efforts, as we compile this information and lead up to our pivotal study called WATER IV, which I'm gonna touch on here at the end of the presentation.
Where we started first, you have to study safety. Four years ago, we looked at Grade Group 1 and 2 patients, and we measured circulating tumor cells. This information was published last year. Probably, the number one question when we started was: Are you going to spray prostate cancer cells all over the body? The answer is no. We measured circulating tumor cells before the procedure and right after the procedure, day one and day seven. By day two and day seven, it looked just like it did at baseline. That's been published. We've checked that box. There was another man with known prostate cancer. However, you could be on active surveillance and still have LUTS, and you need to deobstruct the prostate. They went back, and they looked at their data series.
I'm gonna talk about this a little bit later as to what they saw from an oncologic benefit out for five years there. We did the 02 study. This is a smaller study, safety study, feasibility. This was a precursor to the WATER IV study. I'm not gonna talk about the details today because it did its job. It showed procedural safety, undergo a radical prostatectomy. Whether that Aquablation is being done for BPH reasons or whether that Aquablation is being done for cancer reasons. In 14 patients, the point here is that radical prostatectomy is a very feasible procedure following Aquablation therapy. We don't want to remove options for these patients, but we want to be able to treat them as a frontline treatment. PRCT001 , you see .B or version B.
We expanded that original protocol to go up to 125 patients. This is the data series that I'm going to talk more in depth later on in the presentation. WATER IV we just touched on. First, let me talk about the procedure and how it's different than BPH. BPH, you guys have seen, we've stood up here for years. We've shown videos. You start in a sagittal view, meaning your bladder's on the left. You kind of see this cross-sectional view of the prostate. We plan in transverse, meaning it's an axial view of the prostate. You can see us doing angle planning there. What does this look like? Before, on the left. On the right, you see this unobstructed channel that has now been created.
This is the goal of BPH, which is, how do you get those durable results? How do you get the dramatic reduction of symptoms? It's because we're removing obstructive tissue. If you look at this in the axial view, again, the green lines show the border or the capsule of the prostate, and the inner green line, where the dark is, which is representing fluid, this is a deobstructed prostate. This is the goal when a patient comes in and they're retaining fluid in their bladder, they're getting up four or five times at night. This is how you fix that.
This is also when you ask a urologist, who is not part of our clinical development program, "How do you think Aquablation is going to do with prostate cancer?" They're like, "They only treat the transition zone, and most of the cancer is in the peripheral zone." This is why one would draw those conclusions. Let me walk you through how we do a prostate cancer treatment. This is kind of the pre-op view. Up at the top, you see a 3D rendering of MRI. This is just for kind of understanding. You can see the green. It looks like an M&M there. That is an MRI-visible lesion. There's your prostate, both sagittal and transverse. This is what we see. Same view, same system, same approach what we do.
Our approach, though, and our conclusion as to what we get is much different. You see the images on the right now. All you see is a thin layer of a capsule that remains. There is no longer the tissue that's left behind. We're not just deobstructing the prostate. You can see it in transverse, and you can see it in sagittal as well. Very different procedure. Instead of a couple waterjet passes, it could be three, four, five waterjet passes. Do we leave the remnant tissue behind to let it slough off? No. We make sure that is removed at the end of the case. Our surgical goals and aims are different when we're treating prostate. Remember, I started at the beginning, which is: Are we going to do a whole-gland treatment? We are doing a whole-gland treatment.
This is what excites surgeons about the capability of this procedure. Just to kind of put them side by side, the image on the left here, we're deobstructing. We're helping people's urinary symptoms. This is for BPH. The image on the right is we are going after the whole gland so that we can get all of the cancer, whether you can see it or not. Just to confirm what we see at six months, does that cavity remain? This is a six-month MRI of the patient that I just showed, and here you can see in two different views of MRI, that same void, removal of tissue remains. Now, let me jump into the data. We've talked about the 01 feasibility study, if you will. We did this in 2022. As of last month, we have now completed the whole series here.
I'm going to walk into this data and kind of our first interim analysis for that data set. First, I'm gonna talk about the Endeavor Health series that I mentioned at the beginning. What this group did was they looked at their Grade Group 1, so low-grade disease, active surveillance group. They parsed that information. They said, "Of that group, which one underwent an Aquablation for BPH? Let's compare it to the active surveillance group only, and let's look at their oncologic, their cancer progression, over the course of five years." What they found was the group that underwent Aquablation for their BPH, which was the original procedure protocol I showed, there were 44% fewer upgrades at five years compared to active surveillance alone.
It's another clinical evidence point of, "Can Aquablation alter the progression of cancer over time?" This was published last month. It's online and available. Very promising results. You get into the 01 study. We completed 124 procedures. You can see 90 of them have reached their six-month follow-up visit, and 37 of them have reached their 12-month visit. What does this mean? As time goes on, this data will mature, and we will have patients at all of these time points going out to one year. We're gonna share the data that we have today. Two-thirds of the patients had Grade Group 2 or Grade Group 3 disease, and two-thirds of these patients had disease in the peripheral zone. This represents a very normal prostate cancer population. This isn't a transition zone only.
This isn't just low-grade disease. This is a very typical profile of a patient. Okay, going to what Larry and Pooja have touched on, which is, okay, radical prostatectomy, whole-gland treatment, it's a very good procedure. Why is active surveillance growing as the number one treatment choice to start with when somebody's diagnosed with prostate cancer? This is the reason. SHIM score is a five-question questionnaire that a patient will fill out that identifies how severe your erectile function is. The ProtecT study, the AFU study, very credible studies that have been done, very published, or very well published in journals today. Here you can see a higher score, better erectile function. A lower score, below seven, severe ED. You can see in both of these studies, relatively good erectile function, age, low 60s to mid-60s.
You can see after the procedure, at one year, you're seen in the severe ED category. There is no return for this over time. This is a permanent condition. If you have this at one year, this is where it's going to stay for one year. When you look at our data, this is the first time we've shown our one-year data, you see a stable number from baseline to six months to 12 months of the same survey tool of a SHIM score. Again, our ability is, can we break off the balance between a whole gland treatment and the side effect risk that comes with this? This addresses the erectile function side of things.
When you look at pad use incontinence, again, you see this rise up approximately 50% of patients at six months following a radical prostatectomy, you get some recovery at 12 months, this is where you get the 25%-35% risk at one year. When you've looked at our data from this series that we're talking about today, from the 01 trial, you can see a very low rise of incontinence here at three months. We'll continue to monitor this or excuse me, at six months. We'll continue to monitor this out to one year. Another benefit of removing this much tissue, this population in this trial, you can see a baseline IPSS score of 17. They do have LUTS.
There's many men have both prostate cancer and BPH symptoms. You can see here, we started out with a group of moderate score of 17, then over time, this gets below six, which again, is right in line with when we do our BPH studies, these are the typical results that you see. Lastly, how do you measure efficacy? Efficacy is measured of, do you need another treatment for your cancer because you either missed it at the treatment onset, PSA starts to rise, additional imaging, additional biopsy? Here is radical prostatectomy. 6%-7% of patients at one year will need additional therapy, and it comes in the form of additional radiation therapy, hormone therapy, but these are very good results.
If you compare this to, what have we observed in this study to date? You can see about a 7% risk of needing something else after their Aquablation procedure. Very comparable to the radical prostatectomy results that have shown in these studies. Now, I've just shown you a lot of data. It's gone out to one year. However, in order to change kind of the approach in this field, you have to do a randomized study. That one study is not going to be enough on its own. We've talked about this for the last year and a half, that we've launched the WATERFORCE study. I'm not going to spend a lot of time going into this.
280 patients randomized against radical prostatectomy for Grade Group 1 to 3 patients. It will follow patients out to 10 years. The first primary endpoint is at six months, and then annually thereafter, for 10 years. As we exited last year, one year to the day yesterday, was the first patient we treated in this trial. It's one year and one day. Our aim to enroll and randomize 280 patients. As we exited last year, we had 31 global centers. You can see the little dots on the screen there. We are averaging less than 60 days from consent of patient to treatment in the OR. Where we're at today, we are on track to finish procedures in this entire study by the middle part of this year, so this summer.
Just over 15 months from the day we started, we will have concluded our 280 patients. That's what will set the time frame for primary endpoint, secondary endpoint, and so on. We've been very pleased. We've been very, a great collaboration with surgeons. There's a strong surgeon desire to enter into a randomized clinical study because of the potential of what Aquablation can offer in this field. You get into technology. How do we enable this? A little bit of going back. AquaBeam, on the backs of AquaBeam, we used that for a little over 10 years. Well over 100,000 procedures done on that platform. You can see it was two systems, if you will. A standalone ultrasound machine tethered to our robotic platform of AquaBeam.
18 months ago, we launched HYDROS. There's one tower. This is the world of integration. We've now integrated a number of things. Not only did we do things for the surgeon, meaning AI-assisted ultrasound interpretation. Excuse me. The staff is important for setup, turnover, efficiency in a hospital. This system allows for that. This system is also a platform that we could build upon. Late last year, we got a clearance from FDA on our second generation of AI. We continue to build on our AI, our ability to be better, have higher predictability with ultrasound. AI reads faster, we have a platform that we can continue to build on this. As I touched on earlier, expanding patient applications and indications. Clearly, prostate cancer is the next one that we're going after.
In conclusion, if there was three things you're going to remember from my talk: prostate cancer is a multifocal disease requiring a whole-gland treatment. Aquablation therapy, in a prostate cancer sense, is fully capable of doing a whole-gland treatment, and our growing body of evidence puts us in position to be considered a frontline treatment for prostate cancer. With that, I will turn it over to our CFO, Kevin Waters.
Thanks, Barry. I'm going to be the odd guy that stands behind the podium, I guess, to give my talk. I have four goals that I'm going to go through here today. First, I want to give everyone a brief overview of our 2026 financials. I want to give a walk on our 2026 guidance. Well, Larry and I took a lot of questions last night about our ability to achieve our guidance, particularly around procedures, given the growth implied in the second half. I want to do a procedure walk for the group here on a cohort analysis. I would like to discuss our 2027 financials. This is going to be the first time PROCEPT has put a multi-year plan in place.
Lastly, I'm going to hit on just overall profitability, our cash generation, and we'd like to put to bed any concern around our ability to operate the business, the profitability with the cash we have on hand. With that, flipping to just a little bit of our history, you can see here our revenue growth over the last four years has been robust. What is interesting, though, is the mix, and Larry alluded to this. We are really turning into a procedure business. If you go back in time, in 2021, over 50% of our revenue was generated by systems. That number in 2026 is going to be less than 25%. This has really moved to a procedure-based business, and with that, you see the expansion in gross margins, which is a nice tailwind.
When you do more procedures, which are at a higher standard margin, that's also gonna be reflected in our 2026 and 2027 guide. When you look at EBITDA, we've had a significant EBITDA improvement each year. Our 2026 guide, while still negative, does assume our EBITDA positive in the fourth quarter, and we're gonna show significant improvement in 2027, which I'll get to here in a few slides. Want to move this? Use this or this? Okay, gotcha. Thank you. Here's just a procedure walk, how our procedures have trended over time. You could see 60% growth in our installed base exiting 2025, with over 718 systems. Our guidance implies in 2026, north of 900 systems in the U.S.
When you get to the end of 2027, we're not gonna guide to an absolute number, but you could be assured that we'll be well north of 1,000 systems in the U.S. When you think about prostate cancer and the timing around that, particularly around 2028, that's when we'll be able to leverage that installed base to do prostate cancer procedures. Financial outlook, going through our revenue in both 2026 and 2027, and what that's gonna look like. We guided yesterday to $390-$410. That represents the growth of 27%-33%. I think we've gone through many of the factors earlier today around ASP, around some of the destocking that impacted the change from the previous guide.
Importantly, this is not a business that at our growth, we expect to slow in the near term. We do expect the growth in 2027 to still be in the 25%-30% range. That will be a business that's north of $500 million in revenue. You're gonna see in a second here, that's gonna be a profitable business. We feel good about our ability, given the procedure nature of the business, given how early we are in the market penetration, to continue to have above-market growth rates, even at revenue amounts greater than $500 million. Really pleased with that. When you switch to gross margins and what gross margins looks like, we guided to 65% gross margins in 2026, in 2027, we could see this number getting as high as 70%.
That's due to a few factors, the biggest being the shift to the procedure-based business and procedures being a much greater portion of our company. Over time, we've done, I would say, very quietly behind the scenes, a very nice job getting the cost of our procedure down to levels that will support company margins at 70% when we really start to be a majority-based procedure business. How does that translate to EBITDA? You saw our EBITDA guide yesterday, which was a loss of $30 million-$17 million. However, we see up to a $60 million EBITDA improvement in 2027, meaning that when we go positive in Q4 of 2026, this isn't a business that's gonna bounce around profitability.
We see profitability at some pretty substantial amounts in 2027. I would just remind everybody, Barry just went through kind of a wonderful summary of prostate cancer. None of the financial metrics up here assume any contribution yet from prostate cancer as well, which was another factor why we think the growth rate moving past 2027 is very sustainable. What drives this revenue growth, and what is our focus over the next year here? It's all about same-facility procedure growth. We are going to focus on growing procedures within our existing accounts, that is the job of our utilization team, and we're gonna do that. We're gonna focus on it.
We've now bifurcated the launch teams to focus on launches, to take that burden off of that team. We could focus on growing procedures within our existing accounts. Handpiece pricing discipline. Larry's alluded to this. We're guiding to a $3,500 ASP here in 2026. That's up significantly. That's close to a $20 million tailwind. We are not seeing customer pushback. Larry and I took numerous calls last evening about kind of customer receptivity around this price increase. I think it's important to remember that we didn't go to customers and raise their price. All we're doing is holding our customers and ourselves accountable to our list price, or the price that has been agreed with our customers. Will we still work with customers with volume rebates and pricing and large IDN networks? Of course.
That's being a good partner to our customers, and we're gonna continue to do that, but the days of giving quarter-end discounts to drive volume are behind us, and that's now being reflected in our ASP. Then operating lease payouts, Larry alluded to this. You know, obviously, I think in capital equipment, we're all familiar with companies that use this strategy to place systems. I don't think we're anywhere near in our kind of market penetration where these companies are, where this will represent a majority or a large portion of our placements, but there's definitely hospital networks out there that have patients to treat, and we're not accessible to those patients under our current model. Given our strong balance sheet, given the fact that we're marching towards profitability, we can now offer this.
Three, four years ago, when we had to raise money, when we did not see profitability on the horizon, this was not an option that was available to the company. We're now gonna leverage our balance sheet to get our technology in the hands of more patients and customers through operating leases starting in 2026. This is a guide walk, and it's in your slides, or in your slide deck, excuse me, I won't belabor each point. This is kind of the contribution amongst the different lines in our 2026 guidance. On system revenue, I want to talk about that and how we're gonna report system revenue moving forward. We will be reporting total system revenue.
The business now is much more complex than it was five years ago. We're going to have replacements. We're going to have second systems. We have relationships with all large 17 IDNs in the United States. The days of just multiplying the number of systems we sold by an average ASP, and that is judging the health of the business, I think we need to think differently, and so we're gonna try and reflect that in our guidance here moving forward. We're gonna guide to a total revenue number and an installed base. Everybody will be able to back into an average selling price to the, to the. If it differs from what we've put forth or what expectations are, of course, we're going to talk about it. Our goal is to be more transparent, not less.
I just want everybody to be crystal clear with how we're gonna talk about the business, and that started with how we're guiding to procedures. You now see we're giving procedure guidance as well. That's reflected here as 60,000-64,000 procedures next year. As Larry said, our handpiece sales will more closely align with procedures, but there's probably more room for upside than downside in that metric as we move forward and think of customer inventory and what that needs to look like. This is the historical walk on the right here as to what procedures are gonna be compared to the 115%-108% over the previous years.
The next slide here that we're gonna talk about, I'm gonna spend some time on this slide, and this is the walk to how would we get to the low end of our procedure guidance. Again, I think a big concern of our shareholders, analysts yesterday, were given where Q4 was trending and what our Q1 guide implied, how big is it a stretch to get to the low end of guidance? We're not naive. You don't want to lower guidance twice. We get it. We just lowered guidance. When we went through the setting the bar of the low end of guidance, we wanted to set a floor that we had a high degree of conviction we weren't gonna need to revisit later in the year.
When you look at what this slide implies, these are procedures on the right for 2026. 60,000 would represent the low end of our procedures. 43,000 would represent what we did in 2025. I'm gonna take the blue bar at the bottom. Our 500 + accounts that were installed prior to 2025 contributed 36,000 procedures in our 2025 results. Pooja and Larry just spent an hour telling you how we're gonna drive utilization in that group, why we could be better, how we're gonna drive patient awareness, how we're gonna drive same-store sales. Our low end of guidance assumes none of those initiatives really take hold. We're expecting those accounts to go from 36,000 to 38,000. That would be less than 0.3 per month per account in our installed base.
The low end of our guidance would suggest that the initiatives that we're implementing really don't bear any fruit in 2026. On top of that, when you look at the next segment of customers, those 7,000, those are procedures from accounts we installed in 2025. All we're assuming is that the low end of guidance, their run rate stays the same. They do the same number of procedures, and now they have a full year of procedures, and therefore, they're gonna do 14,000, which is 2x what they did in 2025. When you move forward with the new accounts in 2026, we're essentially expecting those accounts to do 8,000 procedures, which is about the same number as our new accounts did in 2025.
We just spent time going through launch teams and focus and launching accounts. We showed data about time to first cases, and that's improving, but the low end of our guidance assumes the status quo. Obviously, at the high end of a guidance, that would be 4,000 more procedures. Even at the high end of our guidance, if you took that bottom bar, that would assume that each account would have to do about half more procedures in any given month in 2026 as compared to 2025. I appreciate growth. I appreciate when you look at procedure growth on the surface, that the back half is north of 50%. We recognize that, but we also recognize that we're not asking for every initiative that we're launching to bear fruit immediately to hit the numbers.
These are not the numbers the management team at PROCEPT is aspiring to in 2026 either. We wanted to put guidance out there coming off of Q4 that we felt was achievable, and we wouldn't have to reset. A few other factors as to what does the low end and the high end of our guidance imply, and why do we have a range? The low end is essentially the status quo, as I mentioned, but the high end does assume some organic procedure growth in legacy accounts. We do start to initiate a replacement cycle, and that replacement cycle of the $100 million, you're probably looking at a 5%-10% contribution from the replacement cycle to put it in dollars for the group as to what we're expecting in 2026.
We really don't start to really get some momentum in the replacement cycle until our 2027. That makes sense. If you look at the age of our AquaBeam systems, most hospitals will look at our equipment as a five-year useful life. We really started to accelerate placements in 2021 and 2022, which would suggest that the replacement cycle really shouldn't start in earnest until the back half of 2026 or 2027. We are forecasting ASPs now of $3,500. We feel good about that.
We're, you know, two months into the quarter, and I'm not going to talk a lot about the first quarter, given we're right in the middle of the quarter, but I'll just say that the pricing that we've seen over the last 60 days has informed us as to the guidance that we've put forth here around 3,000-3,500. Then again, going to 2027, how are we going to continue to have the sustained growth north of 25%? The growing installed base is definitely a tailwind to procedures. We're going to increase replacement revenue. We see relatively stable handpiece pricing and also relatively stable system pricing.
We made some commentary at the end of our third quarter about the capital environment, I think a lot of people took those comments and ran with it, so to speak, that we were trying to signal the capital environment was weak or we were seeing pricing pressure. Capital environment we feel is stable. We see pricing is stable. The decrease in system ASPs in the fourth quarter were more due to type of customer sales. We had a lot of large IDN sales. They typically get a larger discount than a one-off hospital. That was reflected in the $425. We see that moving back up to the $440-$450 range in 2026 and feel very good about the funnel.
When we think about profitability and longer-term EBITDA expansion, and how we're going to get there, we do believe we're going to have operational efficiencies. I'm going to focus here on R&D and our sales and marketing group in the next few slides. Let's first, before we get there, talk about gross margins. Gross margins going from 65%-70%, that I would say we did not feel two, three years ago that 70% of $500 million, that was going to be a heavy lift, but we've done a good job with operational efficiencies, the cost of our product, the handpiece component of our business, and that tailwind to margins is really going to be reflected in 2027. Tariffs, that is, an ever-changing topic.
I'm sure we could wake up tomorrow morning and the news will be different. What is factored into our guide today is no impact from what was recently announced, I think was 48 hours ago. We're obviously aware of that, but we have put into our guide a tariff expense of around $5 million-$6 million in 2026. That would assume nothing changes with our exposure, and our exposure, to remind everybody, is primarily to our ultrasound supplier in China. We feel good about our pathway here on margins, and this is, again, going to be a, it's a long pole in the tent for us for profitability, because when you get to other areas of the business, we do start to demonstrate significant leverage.
Our R&D spend has been heavily influenced in the last 24 months for the WATER IV trial. The majority of that spend really ceases in 2026, where R&D spend in absolute dollars is going to be relatively consistent. What that does as a percent of revenue is it really gets us down to more of a mid-teens level, which is more reflective of a more mature medical device company. We're innovative, we're robotic. I never see this business being in the 8%-10%. I think that's too low for a business like ours. Settling somewhere in the mid-teens is something I think folks should expect in perpetuity and will give us plenty of resources as our revenue grows, to continue to innovate and do a lot of exciting things in R&D.
That will be a huge source of leverage for us here as we move forward. How does that translate to adjusted EBITDA? You have our 2026 guide. We're now guiding to 2027 EBITDA in the $25 million-$30 million range positive, so that is a positive $25 million-$30 million. That is a $60 million improvement over 2025 at the high end, and it's the factors we just went through. It's high procedure growth, 68%-70% gross margins, leveraging R&D, and then beginning to leverage our sales force. One thing Larry mentioned on the call yesterday, we are starting to pilot a hybrid sales model where we will, longer term, not be required to be in every case.
We're still going to be great partners to our customers. We're still going to support our customers. This does not mean our reps disappear from our accounts. We're a high-touch model, we'll still be there. At the same time, we do not feel, given kind of where we're at with the clinical results of the product, we need to be in every case, and that's going to be a tremendous source of leverage for us as we move forward. Lastly, here on the balance sheet, and kind of what does the balance sheet look like? Cash, let's just address it. We never expect our cash to go below $175 million.
We think we're going to be cash flow positive in the fourth quarter of 2027, perhaps earlier, perhaps a quarter later, it's somewhere around the end of 2027 where this business becomes cash flow positive. Working capital, accounts receivable, inventory, we think we have room for improvement there, we're going to continue to improve on that, and that's going to be a driver to us becoming a cash flow positive company. As a reminder, we require little CapEx. Working capital is the driver of this business, therefore, you know, as our revenue grows, there's not a lot of CapEx required in this business.
We're in a facility that has more than enough capacity for the foreseeable future, even if we were to consider alternatives in the near term, that would not be a significant outlay for PROCEPT to go do that ourselves. Very, very small CapEx. When you translate that to the fourth quarter of 2027, that cash flow positive is important because we do have $52 million of debt that becomes mature in 2027. We have no plans to refinance that debt. If you look at the terms of that debt, it's probably one of the more favorable debt instruments outstanding right now. We have great pride about the trajectory of the business. I myself, like Barry, have been here. I'm one of the old-timers.
... now becoming friends with Pooja and Larry as well. I'll just say it's, this isn't, I can't monetize this, but I do believe with the leadership team we've brought on board here, while Q4 may be frustrating for folks in the room, investors, they're frustrating for myself, I've never been more excited about the future and direction of PROCEPT. I thank everyone for being here and coming on this journey with us. At this time, I'd like to invite up the management team. We're going to start the moderated Q&A. Matt's going to come up to the podium, so just give us 30 seconds here to get situated, everyone on the web. Thank you.
Yeah. Okay. We're going to start Q&A now, but we will be prioritizing those that are in the room. I do have an iPad in front of me right now to monitor the chat. If you do have questions, please send those through. We are going to be prioritizing those in the room. Chris, go ahead.
Thanks, Matt. This on?
Is that on? Are we good?
Testing. There we go.
Okay, there we go.
All right. Chris Pasquale, Nephron. Thank you guys for doing this. One question on the cancer opportunity, then wanted to follow up on something for Kevin. On cancer, what is the key to unlocking that opportunity? Is it specific FDA labeling? Is it publication of a certain length of follow-up? Would just love to sort of level set at what point, as you're following these patients for 10 years, you know, when do you think you have what you need to really go out and commercialize for that indication?
Yeah. I think the first thing is we have to complete the trial and see the data. You know, for those of you that follow the journey at Edwards, you know, we have great confidence when we start these trials. I think Barry and the team have done a great job designing the trial, but we have to see the trial results, and the trial results are going to inform where exactly this resides in the treatment of cancer. I think we're going to present those results at AUA in 2027. Right now, we don't have a contraindication against treating patients today, so a patient, you know, if doctors wanted to treat patients, there wouldn't be any obstruction to that.
What we do with the labeling and how we approach that with FDA is going to probably depend a lot on the strength of the data. That's probably going to inform our reimbursement strategy as well. We'll have to wait to see the data before we'll actually be able to answer that. I think there's a lot of people that go out and talk to talk to folks and say, you know, and people are a little bit bearish on the role that Aquablation can play in cancer, and so we've tried to really bring that to light. I think part of the disconnect there is people are saying, do I think Aquablation is going to be better than a radical prostatectomy for the treatment of cancer? I think that's just an absolutely wrong question to ask.
That'd be like saying, is TAVR going to be better than open heart surgery? When you have a procedure that's going to preserve the quality of life in the way that our procedure does, similarly to what TAVR was able to do for aortic stenosis patients, the biggest growing segment is watchful waiting. The big thing we have to do is provide a meaningful option for those patients who would rather do nothing and give them an option to, you know, treat their cancer. Even, you know, if we don't know what the data is going to say, I haven't seen the data, I have no idea what it's going to look like.
If we're anywhere comparable to a radical prostatectomy, and we can protect people's quality of life, their urinary function, and their sexual function, to me, it's just a home run opportunity for these patients. The patients that are sitting on the sideline, I don't believe they're sitting on the sideline because they want to have cancer in their body. They're sitting on the sideline because they're unwilling to live with the complications the treatment involves. If we can provide an answer for them that doesn't have those complications, I don't know why anybody wouldn't choose having that procedure done versus waiting, and that's why I think cancer is such an exciting opportunity for us. Again, it starts with, we designed a very good clinical trial. The clinical trials in urology, you know, coming from a different space, are typically registries.
The follow-up's a little spotty, you know, they tend to be really small trials. The trial that Barry designed, you know, and he grew up in the cardiovascular space, so he designed a very cardiovascular-like trial that's randomized, that's very high quality. We've, you know, really run that trial very, very carefully, and I really commend the team. All that work was done before I got here, so I don't get any credit for it, but I can certainly admire it, and they've done a great job with that. I think this is a very robust trial. It's going to be level one evidence that's going to inform this. We walked through the reasons why we're confident in that trial.
Again, it is also what the patients are doing today and why I believe this is going to be a strong option for patients, assuming the trial is successful.
Thanks. Kevin, you talked about how the drivers of revenue growth are shifting from what was historically more of a capital-driven model to now, disposables being the primary driver of growth. Your 2026 guidance assumes flat system placements, which is a bit of a change from the company. That number has ticked up consistently over time. On one of your slides, you said you were about 25% penetrated, I think, into the install base opportunity, could expand your kind of system placement TAM, or is this just a reflection of some of the priorities that Larry has around really optimizing utilization versus trying to maximize placements?
I'll maybe start on that, and then Kevin can certainly weigh in. I think, you know, I think our capital plan for greenfields, I think, is right now the best place for us to make sure that we're preserving price discipline, and we're adding to our installed base in a responsible way. Remember, the other part of that is, when you add to the installed base, you have to train them, you have to, you know, launch them, you have to get them up to speed. It's not just the capital team side of it's also the utilization team side of it in terms of being able to support these centers. We think that is a sweet spot. Remember, the other things that we're adding on to the capital team.
In addition to the launch program, we're also adding on introduction of a replacement strategy that we think is going to be a bigger part of our story. It's a small part of our story in 2026, but it'll be a bigger part in 2027. We're also going to explore some leases. As it relates to ASCs, like, I think that's going to absolutely be part of our future. Right now, though, we feel like there's still a great opportunity in greenfields. One of the things with ASCs that we have to make sure that we're doing is that we're not just shifting volume. If we install in one of those systems, and all somebody does is take their volume from, that they're doing in the hospital and move it over to an ASC, that's not gonna grow our total procedure volume.
What we have to make sure is any place we go, that's gonna drive incremental volume that we wouldn't have otherwise gotten, and not just shifting from one side of care to another. That's the area that I'm really focused on. The metric that drives us, that drives me, that I track more closely than, is what is driving our procedure growth? That's absolute procedure growth quarter-over-quarter, and I think that's what we need to do, that's what we need to execute on, and I frankly think that's what you guys need to see. That's what our investors need to see to get confidence in our long-term growth thesis, and that's what we're focused on.
The second part of your question is on the 25%. To answer directly, Chris, that's then of 25, so that would assume there's roughly 2,800 hospitals in the U.S. that do BPH. Just last, on the kind of flat year-over-year on greenfields. You know, we've always known, and I've been in the fourth capital equipment company, procedures drive capital. We get it. When we first started, we didn't have any procedures, so therefore, we had to sell capital, and I would suggest that as procedure initiatives take hold, that will fuel capital growth year-over-year. Capital growth will be fueled by procedures. We see accounts today that are high volume, that want and need second systems. We're starting to see that.
We obviously are planning down the road to have another indication that would drive that. I wouldn't view 2026 as how we're viewing the business in perpetuity. We also have a lot of innovation going on that should drive capital in the future, but for 2026, for all the reasons we've gone through, it is flat. I wouldn't suggest that's how we're viewing the business every year for the next five years.
Thanks. Great.
Nathan Treybeck, Wells Fargo. Thank you for putting this together. Kevin, I just wanted to talk about the cohort analysis you put together. If my math is right, it shows kind of the legacy accounts. Monthly utilization is around six, 2025 cohort is about 5.5, and the 2026 are gonna be less than one. My question is the six per month kind of where you max out? Why does the 2025 cohort get there so quickly? Is most of the upside or most of the upside to the high end of your 2026 guidance on the 2026 cohort?
I'll start with that and just. What we tried to do is just really simplify the procedure walk, because I think people are looking at 43,000 to 60+ and saying, "That seems like a lot of procedure growth." We wanted to be really clear where the procedure growth is coming from. I know that from an Excel standpoint, looking at utilization per instrument is just a really easy way to model things out. I don't think it's a particularly useful metric because there's just a huge amount of variability in our installed base between what their utilization numbers are across. Taking an average and applying it just really isn't representative of anything because the spread is so wide. What we're focused on is how are we gonna grow procedures quarter-over-quarter on an absolute number?
The walk is really just trying to explain how we get to the bottom of the guidance, which is basically saying: Our installed base is going to do a tiny bit more than what they've been doing. You're talking about our installed base of 718 systems in the U.S., adding 2,000 cases in total. Not very aspirational. That would suggest that it's taking longer for a lot of our programs to get traction and do. Is that our plan? That is not our plan. Our plan is to get traction on those much faster and see more utilization growth there, but that's what's in our model. You can say: Okay, our new systems last year, they, if you just average it out, would've been available for about half the year.
They did about 7,000 cases. We'll have a full year of them, but they just kept doing exactly what they were doing, nothing more. That gets you to 14. On top of that, you say, "Okay, we're gonna install about the same number of systems this year." They did 7,000 cases last year. We have launch teams this year, so we think we'll get a little bit more out of those. We'll get 8,000, and that's the walk, and that's how you get from 43 to 60. It's not about trying to, you know, move the utilization number, you know, by 0.2% per site or any of that sort of stuff. I think it's about us going out and attacking those centers that we think have the best opportunity for growth, and driving those, and driving to those absolute procedure numbers.
One follow-up. One of the charts you showed, it shows simple prostatectomy and enucleation are actually trending up. I would've thought maybe flat or down with. You know, that was the Aquablation value proposition, that it was gonna move a lot of the procedures to Aquablation. I guess, what is driving the growth in simple prostatectomies and enucleation at this point?
Barry, you want to take that?
I'll take that, yeah. I think a couple reasons. I think you gotta think about the size of the glands that have happened over the last 20 to 25 years. When patients are put on medical therapy or a non-resective procedure, it is allowing these prostates to get larger and larger. You get down to it, a prostate over the size of 80 almost is untreatable from a TURP. You know, the older days, they would stage a TURP. You'd go for one procedure, they would do the left lateral lobe, go home, come back a few months later, and do the right side.
You look at simple prostatectomy and enucleation are tools that can be used in large prostate sizes, along with Aquablation, and I think that's where you're seeing a lot of the growth, which is the prostate size market. It used to be small. If you look at publications from 20 years ago, the average prostate size was 50. Our global average is 90, and that's because people are delaying resective procedures because of the advent of medical therapy and non-resective procedures.
Suraj Kalia from Oppenheimer. Larry, Kevin, thank you for providing all the information. Three questions, if I could. Larry, for you, I appreciate your commentary about TAVR, but BPH is not life-threatening per se. It's a quality-of-life issue, and y'all are making a certain stance in terms of end-of-quarter purchases. Totally appreciate that. What does game theory suggest to you? If you guys do this, what are others gonna do? Have you all factored that into your calculus? If they continue their current practices or change, how does that impact you all?
Well, I mean, there's a lot that goes into it. First of all, there's a lot of people walking around with aortic stenosis that don't believe it's a deadly disease either. And I'm not saying that BPH is a deadly disease, but it really is about symptom tolerance. I think when you talk to men who have BPH, their quality of life is deteriorating, you know, significantly. That's why people are abandoning drugs. They don't like the side effects and the other challenges with that, but the treatment option seems so severe that they're unwilling to do that.
In terms of game theory, I'll say one of the things that was surprising me when I joined the company is I was used to competing in the TAVR space with Medtronic, who spent the same amount I did or more, Boston Scientific, who was aggressively trying to enter the space, Abbott, you know, who was investing and aggressively trying to enter the space. We don't have anybody. You know, who are the big strategics that you're going and sitting in their meetings where they're spending their whole time talking about BPH? I suspect it's nobody. I mean, you look at where UroLift is today, it's been declining year-over-year. I think they just got packaged into some other deal and got sold. You know, there's nobody really behind TURP.
People sell a general use instrument that people are using for this procedure. There's nobody marketing, there's no marketing campaign going on for TURP or any of these other sorts of things. I don't have all these established competitors all sitting around us that are outspending us, that are trying to drive new evidence, that are trying to drive anything. It's basically just us, and we have to go execute against historical norms. Look, changing the practice of care is hard. People do what they're used to doing. They're doing what they were trained to do. Every urologist that came through school learned how to do TURP, and they're just used to doing that.
We have to change their standard of care, we have to change their practice, it's not like I have some competitor on the other side inundating them with brochures on TURP. You know, you spend your time in all over the industry, how many people do you go sit in front of who are sitting here telling you, "Let me tell you my game-changing BPH strategy," who says, "I got a war chest of money that I'm gonna go spend to go drive it?
Got it. Kevin, one for you. I appreciate the math you presented, step up from 43,000 to 60,000, you know, stratified by sites. To Nathan's question, if I could just turn it a little around, how should we think about these different buckets? How many of these sites are in high-volume, medium, and low-volume sites? The math is the math. I get the math, but it is also going to be influenced by where these sites stack up within these high, medium, low volume, and then, you know, do the sensitivity analysis. Does it really work for these low and medium-volume sites to ramp up to this level?
Look, it's a difficult question to answer. I'm not being evasive. There's many types of customers. We have high volume, low volume, medium volume, that have all been contemplated. I think what we would like to stress, and a big part of the presentation today, and Nate, that's how you approached the first question, we don't feel we're nowhere near where we have the right to be, even within our high-volume accounts today, given the size of the market. That's how we're looking at it. We don't spend a lot of time looking at accounts that and say, "Oh, they're doing three-five . They're medium volume. We treat them this way." We view every account as high potential, given the market.
I mean, what we're trying to cannibalise, and that's what we're doing in the near term here, that's table stakes. I mean, you look at the slides that we went through today, the 80 million men, the 40 million men, the capacity in the OR, it is there. That's what we're focused on. I'm not being evasive, but it's just not how we're managing the business.
Fair enough. Got it.
Yeah. No, I mean, it's just along those same lines. You know, a lot of the programs that became giant TAVR programs for us weren't giant surgical programs. People adopt new therapies if they think it fits in their armamentarium, and I think the fact is, because our procedure is much less technique-dependent and expertise-dependent, we can, you know, use the precision of the, of the robot and the mapping of the prostate. We can take this into places that probably wouldn't be that excited about having a large TURP program, or were really excited about having some of these other complicated programs. Again, I think it's us making our case and driving that, but there's still...
You know, you look at last year, 360,000 patients got a procedure that wasn't ours, and that's the first opportunity that we have to go execute in, is moving share from those alternative procedures and moving it to ours. That's our number one job.
Some of our highest volume users, if you look at their historical TURP volumes, it's not one to one, that those were the largest TURP volume users, and they convert Aquablation up. They're our highest users. We have many high-volume users that didn't do a lot of BPH prior to having Aquablation because they didn't want to offer the alternatives that were available.
Got it. Very quickly, how much is bleeding and post-op hemostasis needed an issue in terms of, you know, patient acceptance or the conversation as far as Aquablation is concerned? Thank you.
No, good question. As Pooja noted with the 70,000-patient publication that's come out, it's really become a non-issue to a patient. It's in our research, it doesn't come up. From the surgical protocol that is reproducible and repeatable that we have dialed in, it's just part of the protocol now. You know, four years, five years ago, yes, it was, it was the talk. We had different protocols going on. Some were having great success, others were confused. We have moved to a world where we have a number of surgeons that are sending patients home the same day. That would not be possible if we hadn't dialed in the hemostasis protocol. Today, it's a non-issue.
Yeah, I think it's important to understand the history of this. When Aquablation first started, and correct me if I have this wrong, because obviously, Barry's the historian here. People were just doing an Aquablation, and they weren't doing any bladder neck cauterization. When they were doing that, there was more bleeding, and I think that was a lot of the narrative when the technology first came out. Once we protocolized the bladder neck cauterization, then the bleeding issues largely went away once that was standardized, and it's really a non-issue. You know, you look at what the TURP procedure is, I think their transfusion rate's about 3 x higher.
Yeah
- than a modern Aquablation procedure. There's still a little bit of this lagging narrative that you hear out there, in terms of fact and in terms of clinical data, it's just not supported by the clinical data with a modern Aquablation procedure and our protocols today. Is that fair, Barry?
Very fair.
Hey, everyone. Brandon Vazquez from William Blair. Thanks for putting this together. I wanna focus one on a little bit of near term and then maybe a longer one, a longer term as a follow-up. On the near term, the procedure disclosures you guys gave were very helpful 'cause you can kind of build from here to understand the visibility that you guys have in the business and how we get to the 2026 guidance. What's harder for us to know, and I hope you talk a little bit about, is, like, what is the reception in the first couple of months? Are the procedure numbers historically going to meaningfully change because you've meaningfully changed the pricing and how the end-of-quarter pricing promos?
I guess, the, again, the question is, like, can you talk a little bit about what you have seen so far in the first two months of the quarter as a reaction to this? Two, what's the visibility you have into the first quarter so far to give a little comfort that, like, we know that those procedure numbers we can build off for 2026?
I'll talk a little bit about what we've seen so far, and I think it's a really, really important dynamic. Normally, when somebody is driving this level of ASP increase, it's because they went to their customers, and they've said, "We're implementing a 10% price increase. Your price went from X to Y, and now you gotta pay this new price." You know, I launched S3 in the U.S., and I did a $1,500 price increase. We had to go contract with every single site. They had to sign a new contract. They had to put it on the shelf. They had to do all that. That is a process that's a challenge because shockingly, and I don't mean to surprise anybody, customers don't tend to like price increases all that much.
We didn't really roll out a price increase here. Customers had a contracted price that they were buying our product for. What was happening is we would do, like, you know, at the end of the quarter, we'd say, "Hey, we're running a special incentive. You know, do you wanna, you know, if you bought more than 50 handpieces, we'll give you this discount," and do that sort of stuff. People were like, "Oh, sure, great. I'll do that discount. I'll stock. I'll do all this sort of stuff." They were doing something and getting something for less than their contracted price. All we're doing now is saying, "Yeah, we're not running those sorts of promotions anymore. We're not running those incentives anymore." Everybody just goes back to the regular price that they've always paid.
There was no argument about it because it wasn't like we had to recontract or anything, but we didn't have to renegotiate with anybody. We just held them to our pre-agreed-upon pricing structure that they'd had. It's not like rolling out a big price increase. We just discontinued a discount they were getting that, frankly, we probably should have never been giving people. We were discounting a product today that people would have paid their regular contracted price for two weeks from now, and it was causing people to take advantage of that. They would run their inventory very, very high, then they'd spend the next two and a half months depleting that inventory, and then they'd just repeat the process all over again. It was causing our revenue to follow that model. I just...
I'm sorry, I just don't think that's a good way to run a business, and we're just gonna discontinue those things. I think ASP is critically important to us. Kevin talked a lot about our path to profitability. Look, I think there's two things that you guys wanna see and that our investors wanna see. You wanna see that we can very durably and consistently grow our procedure volumes, and you wanna see that we have a clear path to profitability. If cancer turns out to be a real adjacency, then it's a whole other leg, and it's a whole other growth driver for us. I think those are the things that drive our future and that drive our valuation.
To the degree that you see the world that way, that's exactly how we see the world, and that's what we're gonna go try to deliver on. I don't wanna talk too much about being in the middle of a quarter, we, you know, we're trying to be thoughtful about this. We gave you guidance for Q1 that factored in all of the factors, all of the sales force changes, all the things that we've rolled out, you know, we tried to give you a guide for Q1. Obviously, we're planning to see a procedure growth acceleration, you know, especially in the back half of the year.
Again, this is why we try to be very transparent about the walk, where the procedures are coming from, what you have to believe to get to the bottom end of our guidance. I will just say, on a go forward, you know, we're just gonna bring a different level of transparency to this. I think one of the challenges that we're dealing with right now is there wasn't great visibility to actual procedures performed, and so people were making assumptions in their model. Even though it's, you know, it's talked about, it's in our filings, I don't know that everybody always understood the delta between hand piece sales and procedures. All of that stuff's gonna be exposed now. You are going to get every quarter, you're going to get what our procedure volume was, and you're going to get our hand piece revenue.
Those things will be transparent, everything will be exposed, and you guys will be able to evaluate the health of our business. For all the drama about the revenue in Q4, the health of our business was never gonna be defined by customer ordering patterns. It never is. What is gonna define the health of our business is going to be our procedure volume, and handpiece revenue is going to follow that, and it's gonna track that.
As well, I think it's important for everybody to understand that reimbursement has gone up to the hospital as well, to be able to support these higher prices. And Barry can hold me accountable here, but I think it's close to now $10,000 at the hospital level, to where the hospital is actually still getting a little bit more money than we're actually passing on to them in terms of price.
That's helpful. Pooja, maybe one for you. You know, I think this is the first time in PROCEPT's history as a public company, we've gotten a look under the hood of kind of the commercial or the patient generation side. Maybe spend a minute. A lot of good information there. How much of this is new? My understanding was there was some level of DTC happening before, clearly not the level maybe needed. Like, what is going to be incrementally new that's coming out in 2026 plus versus what was not being done before? Thanks.
... Yeah, sure. It's a great question. There were some basic fundamental things that were done. I mean, for example, we have a website, aquablation.com. I think what we're really trying to do is a couple things. One is to be very clear about what is the value proposition and what is that narrative. I think there's a lot of variability, I mean, that people actually know it's there. That is also the incremental new for us, is really building a much more integrated ecosystem where we're nurturing these patients through their journey. If they are at the bottom of the funnel and they're trying to decide between therapies, they're having those conversations with the care team at, you know, at the center. Making sure the care team has the right educational materials to be able to engage with those patients.
Making sure they have things they can take home and think about. Then, of course, as we get into that medically managed population, you know, meeting them where they are. A lot of these people are searching online. A lot of them are getting information through social media. They talk to their peers. Facebook was a, you know, is a pretty powerful peer-to-peer tool for patients. While there was some basic content that PROCEPT has invested in, and I give the company a lot of credit for that, I think building a real ecosystem around it and a real infrastructure, and doing that in a very strategic way where we're targeting the right markets, that's what we're gonna do differently moving forward.
I think the biggest thing for me, and, you know, I promise I'm gonna stop talking about my experience at Edwards 'cause you guys probably don't care. When we were launching transcatheter heart valves, every surgeon said, "We don't need a transcatheter heart valve. We treat everybody with surgery, and sternotomies don't hurt." I was like, "Giving them or getting them?" I think the biggest disconnect we have right now is the physician's lens of what he thinks matters to a patient versus what actually truly matters to a patient. I think this issue about procedure durability and being able to get one procedure and get complete relief and not needing another procedure is not top of mind for the clinicians that are providing these therapies.
We have to make it top of mind for them, and we have to make it top of mind for their patients as well and make sure they understand, you know, when somebody says, "Would you like to have this procedure? I can do it in the office, and you can go home today," or, "Would you like to have this procedure, but you might require an overnight stay?" That's the wrong question. "Would you like to have a procedure done in the office?" That's a very different question, and they're seeing the world through the patient lens, not through the economic lens or through their convenience lens.
Thanks. Josh Jennings from TD Cowen. Appreciate the investor day here and all the downloads. As we're sitting here, late February, just thinking about how you guys described the dynamics in the fourth quarter call and just some of the accounts that we're relying on bulk purchasing and that those discounts at the end of the fourth quarter, assuming the last month, we're heading into the last month of 1 Q. Is there anything you can share just in terms of how that phenomenon or that dynamic doesn't repeat itself in 1 Q? I know you guys have worked through the inventories, so these customers don't have the inventory that they did at the end of 4 Q.
Is it just their procedure queues or any dynamics you can share that gets you guys to that comfort zone for the procedure volume guidance you issued and maybe the revenue contributions for 1Q?
Yeah, I mean, I think if I don't answer the right question, then please let me know. I think a lot of the questions people have is: How do you know the inventory thing's really behind you? You know, how have you changed the dynamics, and how do you know it's really behind you? We're not gonna be sitting around having this conversation again another quarter or two about, you know, more destocking. If you look historically, we've, you know, we've been in that 115% of handpieces to procedures. We're modeling for next year that it's gonna be one to one. If I look at since we made the changes in late Q4, and we look at handpiece sales and procedure volumes to, you know, current, those two numbers are about flying in formation.
I would think if there was more inventory that people were gonna take down, there's not been any discounting, there's no perverse incentive for somebody to be, you know, buying unless they're just doing it to support their procedures. That's one of the reasons we think that this is largely behind us, 'cause we have enough, several weeks now where they're flying in formation. Even beyond that, though, we're saying that if people really have right-sized their inventory, then it would mean there would naturally have to be an upside to the revenue plan that we've modelled. We're going to install 200+ new systems, and they're all gonna require inventory and stocking and everything else. This assumes that inventory in the field stays flat to procedures year-over-year.
That's again what creates the revenue delta between our original guidance and between the guidance where it lands today is, we're just not modeling at that 110% or 115%. We're modeling at a one to one. You know, frankly, I think it's behoove us to put a conservative model out there. I think it's behoove us to leave ourselves some headroom if there is any more of this, that it's gonna be more than absorbed with the 200 additional systems and the inventory they take. You know, like Kevin said, you know, we had to reset guidance. That's never a comfortable thing to do. We certainly don't want to do it again.
Understood. Wanted to just follow up on some of the comments, you just referenced the reimbursement changes in 2026. There are many concerns about the physician fee coming down for this year, last year, but the facility fee has gone up. Can you just talk about how that has played out? I mean, is it status quo? Is it overall positive, where the physician fee reduction is being trumped by the facility fee increase? Just the second part is just thinking about 2027 and reimbursement kind of forecast you guys have. Any chance for the APC6 to move to APC7?
We always look for whether there's opportunities to drive enhanced reimbursement from where we are, and we'll continue to explore those. I think, you know, you have it right. The physician payment went down a little bit, but it went down across the board. It's not like it went down for our procedure, and it went up for everybody else and created some dynamic there. Physicians are never happy when the payment goes down. It, like I said, it wasn't something that was differentiable for us. It's something that applied sort of equally across the board. Hospital payment actually went up, and it went up in a pretty meaningful way. For doctors that are employees of the hospital, they get paid on RVUs.
The additional hospital payment, the physician payment doesn't really matter to them 'cause it all gets thrown in. When hospitals can net out the two of those numbers, it's a net positive for them. For the physicians that only get the payment side of it, yeah, it's a negative for them, but it's not like the alternative procedures got some benefit for it. I think it's a negative, but it's not a differentiating negative that-
Perfect.
Any impact in these early days of 2026 just with those two elements of the reimbursement and?
We factored all of it in. Yeah, we factored all of it into our guidance. All of it is factored into our guidance, all of that, all the intelligence that we have on that. Again, I think the hospital payment ultimately is more beneficial to us than what the physician payment is. You know, again, we monitor all those things. You know, I lived this in the TAVR world as well. As TAVR got better and better, the reimbursement came down, but we were able to protect pricing 'cause we continued to add great economic value for the procedures that we're doing.
I think that's the case we have to make here is the efficiency of a program, the amount of the time and the precision that it takes to do our procedure, the low rates of complications, those sorts of things. We need to continue to make that case for why this is the best procedure for people's patients and why it is a good procedure for them economically.
All right, I'm getting a flashing red light, but Stephanie, you can be the last.
Great. Thank you. Stephanie Piazzola from Bank of America. Thanks for putting this together today. Just wanted to follow up on the 2027 guidance that you laid out of the 25%-30% growth. I think that's a little above what the street is modeling, and appreciate the growth drivers that you laid out, but, you know, just curious how you're thinking about this being the right level of growth to set up now for 2027. The breakout you provided for 2026 was helpful with the different cohorts, so any high-level comments of how we can think about that in 2027, you know, what comes from the existing business versus benefit from new initiatives?
Yeah, we obviously guided to total revenue growth and didn't get into the details between, you know, systems and replacement and disposables. What I'd suggest is that 25%-30% growth on the system side does assume we have a more robust replacement cycle, so I'll start with that. It assumes stable pricing. On the procedure business, it is some benefit to the initiatives that we're putting in place in 2026 around the launch team, but nowhere near kind of a best-case optimized scenario where if everything we do with launch teams and marketing initiatives and patient awareness... I mean, I don't know if the slide that Pooja showed where we have 1%-2% patient awareness, frankly, it was shocking to me when I saw that a month ago.
If we could move the needle there, I wouldn't suggest that 25%-30% is upper limit. It's informed on what we know today and what we think is achievable, not hoping everything that we're putting in place is a home run.
You know, I'd say 2026 is, it's a little bit of a build year for us. We have to build out these marketing programs. You know, we've established the teams. You know, we're starting to run the replacement pilots, and learning about that process, and, you know, we're exploring some operational leases and doing those sorts of things. These are all things that we have to sort out, that we have to have in place, that we have to really create the structure around in 2026. These are things that are gonna be a much bigger part of our story come 2027, and that's also when I think some of the marketing programs, some of our awareness programs really you know, we're gonna get a lot more benefit from those programs than we're gonna see there.
I will tell you know, internally, we're much more aspirational on 2027, but, you know, we wanted more guidance out there that. I think the biggest thing that I don't wanna have in people's minds is that, you know, that we're gonna continue to be on this declining growth curve as we're doing it off a larger base. We see the opportunity in front of us. Again, none of those numbers have factored in cancer at all. None of that is built into the 2027 number or anything that anybody has modeled beyond that. You know, that's very intentional for us. You know, we wanna set ourselves up for success on a go forward, and I think that's our responsibility now to go execute and go make that story a reality.
Thank you, sorry, if there's time for just one quick follow-up on the margin side of things. You know, the EBITDA margin expansion that you're expecting longer term, just how do you think about the SG&A leverage within that, since you're making some increased investments? If you could just give a little bit more detail of where the leverage is coming from. You talked about moving away from the high-touch model with reps and having a rep in every case, so any expectations for the plan there, and when we could see that?
You know, one of the things I wanna be really clear on, and I think Pooja tried to make this point, but the programs that we're doing on marketing, one of the things that's unique about this space compared to, you know, sort of my previous world is, you know, something like 5%, 7% of people over the age of 80 have aortic stenosis, but I have no idea who's who. You have to go, you know, cast this wide net and try to find who those 7% of the people are and treat them, and when you're in the 70-year-olds, it's a much lower percentage. You have to cast this wide net and kind of go everywhere, and then try to talk to people about symptoms, and try to filter it out.
We don't have that problem in BPH. The 400,000 people that are getting treated today know they have BPH, and they're actually getting a surgical procedure for it. There's 1.1 million men above that who have failed drug therapy for BPH. They know they have it. They're looking for relief of their symptoms. I don't have to go market to the whole world. I can just go target those people, and we know who those people are, and it's not difficult to find in this modern era. We can be very targeted about these programs, so it doesn't drive this massive SG&A spend. You know, I don't have to do things like we were doing at Edge, just with, like, Target AS or Preview or those things.
We have a much more targeted market here that we're gonna go attack and address. I think, you know, we talked about the hybrid support model, and this really is about getting our hospitals, once they're trained, and they have the HYDROS system and they're experienced with that, we just don't simply need to be there in every case. We're not walking away from our clinical support model. If a physician wants us there, we're happy to be there. We're gonna be in some percentage of cases always on a go forward, because we wanna make sure that, you know, the machine's set up properly and that, you know, as nurses are doing it or staff is doing it, that we don't have any degradation or any of those sorts of things, so we'll be there.
You know, if somebody wants to throw a couple cases on a Friday, I want them to have the capability to do that without having to call and make sure their rep's available or any of those sorts of things. That's why we're gonna move to that hybrid model. I think, you know, what we're gonna try to do is, you know, obviously drive our top line growth. Even in, you know, on a dollar basis, is SG&A and R&D gonna go up? Yes, but on a percent of sales basis, we're gonna get leverage out of those, and those are gonna come down, and that's what's gonna drive our margin improvement. We expect to get leverage out of our sales force, which is the biggest part of our SG&A spend by, you know, by a sizable amount.
Then we'll get it on the R&D side, too. If we can settle into a, you know, a 15%-17% R&D spend as a percent of sales, and we get our SG&A down to reasonable numbers, I think we'll have a really healthy business.
Okay. All right, I just wanna thank everybody for attending in person and also being on the webcast. You know, if you guys have any questions, please email me. Kevin and I, and Larry will be available. We will be at Cowen next week. I believe Leerink the following week after that to meet with all investors.
I just lastly, I appreciate everybody coming today. I know we moved the day because of the weather and the other things. I appreciate your interest in this. You know, we're not where we wanna be right now, but we're doing all of the things fundamentally to get us in a place where I think we can drive that differentiated long-term success that everybody wants to see from us. Make no mistake, it is on us to go execute our plan and earn your trust and earn your confidence, and that's what we're gonna go out and go do. Thank you.