PROCEPT BioRobotics Corporation (PRCT)
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2024 Wells Fargo Healthcare Conference

Sep 4, 2024

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay, excuse me. I think now it's our time. Good afternoon, everyone. I'm Nathan Trebeck, one of the medical device analysts at Wells Fargo. Welcome to our healthcare conference, the first day. I'm pleased to have management from PROCEPT BioRobotics for this session. Joining us from the company is Kevin Waters, the CFO. Kevin, thank you for joining us.

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, thanks for having us. Appreciate it.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

I thought maybe we could start with kind of the most pressing news here, your brand new HYDROS Aquablation System. Can you walk us through the key upgrades to the system relative to your prior generation AquaBeam?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, thanks. So we announced HYDROS, which is our next generation robotic system, a few weeks ago. We've been working on this for multiple years, and it's been a pretty big effort by our R&D group. And when we look at the features of HYDROS, we've really put these features into three different buckets, where we see significant improvements over our current system. First is we've introduced what we call AI Assist, which is artificial intelligence. It's essentially assisted planning to allow the surgeon now to see suggested contour when you resect the prostate tissue. And we do think while we have great clinical outcomes today, the variability in outcomes primarily is related to the treatment planning aspect of our procedure.

So that will be, we believe, vastly improved and, you know, is the next generation where surgery is going with AI. So we feel good about that. The other improvements, one is just around streamlined workflow. While our current system today, the AquaBeam system, has great clinical outcomes, you know, I think it was no secret that some of the workflow around that system was somewhat inefficient in an OR, particularly set up and ease of use. And so the feedback we've received from customers is that HYDROS is a much more streamlined system. It's easier to set up. You don't have to be reliant on perhaps an Aquablation specialist staff within your hospital, and it, it'll improve workflow.

And then just lastly, around imaging itself, our current AquaBeam system utilizes ultrasound technology just like HYDROS, but at the same time, you know, HYDROS does come with improved ultrasound imaging. It comes with a digital cystoscope, which it improves imaging, and it'll just make the physician experience much simpler and palatable than it is today.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay. No, that's very helpful, and you probably touched on this in your explanation just now, but when you announced the system, you talked about being able to pull surgeons off the sidelines. You know, I guess, what are some prior concerns of surgeons who may not have picked up Aquablation? What does this new system address for them?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, our Gen One system, it was always viewed as a first-generation system, and it's really a testament to the clinical outcomes of that product that we've been able to accelerate adoption so fastly with what was originally viewed as something that was more fit for clinical trials. So when we look at HYDROS, it does go back to everything I just pointed to for mass market adoption, right? And there's a lot of things that early innovators are okay to deal with with a new system, but HYDROS just takes it to the next level, and particularly around kind of that workflow aspect and making it just simple and a no-brainer for the surgeon to use when they have any resective case come through their door. Just, it just makes that decision process much more clear in the minds of a surgeon.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay, that's helpful. You know, with the announcement, you reiterated your guidance, and you don't expect any impact on margins from the launch. I guess, can you help explain how trading up of current customers from AquaBeam to HYDROS won't have a negative impact on gross margins?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, so our strategy in Q3 and Q4 is primarily greenfield. We have a robust pipeline. We're still very early in our penetration of the 2,700 hospitals in the U.S. that do BPH surgery. So our initial commercialization strategy on HYDROS, it's a greenfield strategy. In fact, so much so, our reps are not incentivized to sell replacements in Q3 and Q4. We're not gonna give any guidance today on 2025 and moving forward, but we do think there is an upside potential in '25, with the replacement cycle starting much sooner than people anticipated. And when we think about margins and what impacts margins, it is primarily the average selling price of the HYDROS system that impacts margins. The cost is very comparable to our AquaBeam system.

We do think we'll get a higher price for HYDROS moving forward, but at the same time, we do want to allow for customers that bought an AquaBeam in the last one to two years to trade in at a discount, and we think we can do that while at the same time continuing to expand margins.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay. You won't give any more color on the price differential?

Kevin Waters
CFO, PROCEPT BioRobotics

Not really. I mean, the reality is we've guided the $380,000 ASPs for HYDROS in the back half of the year. That does allow for what you described for some users. While we're focused on greenfields, we do know there's gonna be some adopters that want to replace soon, that perhaps we can give a discount to. But as of today, we're just gonna guide the $380,000 for the back half of the year, knowing that we think there's upside to come in 2025.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

So at a higher ASP to AquaBeam, how do you anticipate the ROI on the system to compare to AquaBeam, and would it still be attractive for hospitals?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, we don't think it changes much, the ROI. I mean, the reality is, even with our AquaBeam system today, we have numerous sales that are well north of $400,000. So while our average has been around $380,000, the pricing on our capital has been highly variable. It depends on your Medicare population, depends on your geographic location, it depends on your patient throughput. So we know we can already sell capital for north of $400,000, again, even with our first-generation system. So we don't view HYDROS hindering an account's ROI at all. If anything, we think we could put forth that this should accelerate your patient flow, accelerate your throughput. You know, perhaps now the other surgeons within your hospital that didn't want to deal with the first-generation technology will now be more willing to come on board.

So we think net-net, this is. There's many more tailwinds than headwinds when it comes to HYDROS.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

So there definitely seem to be benefits to surgeons. How should we think about HYDROS helping to expand the resective BPH market in general versus, you know, continuing to gain share from TURP and other modalities? And why would that be? What is it about the system that would drive market expansion?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah. So I don't think HYDROS changes our near-term strategy, which is cannibalization. I mean, we've been very successful in the BPH space. I don't discount that, but we're still only 10% of the resective surgery market in 2024, and have a long way to go to become the standard of care in that space. So in the near term, we're still focused on cannibalizing TURPs and GreenLights. But when we do think longer term, and we think about market expansion, you know, HYDROS is a system that we think does allow for that mass market adoption, that could allow for market expansion, both in the hospital and in the ASC setting.

You know, I think we would've been just fine going to the ASC with our AquaBeam system, but I do think the features I've just went through with HYDROS do lend itself to an ASC to a greater extent than our current system would. But again, we're many years away from having to rely on market expansion to meet our growth objectives.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

That makes sense. You know, I think at the time, you seemed to imply that with AquaBeam, there was a potential kind of ceiling to how much adoption you could have within the 860 high-volume hospitals and the 1,800 low to mid-size hospitals. Would you say, at this point, with the launch of HYDROS, all of these hospitals are now addressable in the system?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, I think we've always felt that if you look at the BPH market in general, to take a step back, there are 2,700 hospitals in the U.S. that do resective BPH surgery. 860 of those 2,700, however, do about 70% of all the volume. And our view has always been, we should be in most, if not all, of those 860. So then it really came to how many of the remaining were we able to penetrate? And while we've done a good job today, 30% of all of our sales today are already in those other low and medium-volume hospitals. But I definitely think a technology like HYDROS lends itself to be more palatable for those hospitals to consider a purchase of our system.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay. You know, you expect some sales disruption in Q3. You know, you're pulling reps off the field for training. I guess, what is your confidence level that the disruption won't linger beyond Q3?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, I think when we think of the cutover, we are doing kind of a hard cutover, where we're looking to convert our full pipeline to the next-generation system. We're pulling all of our reps out of the field in the Q3 to get most, if not all, of the reps trained by the end of the Q3. So we do think Q3 represents the majority of disruption. I also think our full year guidance would allow for some of that disruption to spill over, perhaps into October. But in general, when we get on the other side of twenty twenty-four, I mean, the launch should be behind us, the rep training should be behind us, and we will only be selling HYDROS in the U.S.

So it's primarily Q3, perhaps a little spillover into Q4, but I think current consensus and our current guidance reflects that disruption appropriately at this time.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay. You know, one other thing, though, that was noted is HYDROS may be better positioned to address prostate cancer. Can you elaborate why that would be versus the prior gen system?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah. And look, there's some truth to that, but there's also some misnomers, right? I mean, the reality is, our current AquaBeam system is the system that we're currently running a clinical trial on with 25 patients to treat prostate cancer. So that, that's not changing, and we'll continue to use our AquaBeam system in those accounts, which we said will be fully enrolled by the end of this Q3. So no differences there. With that said, when we think about the opportunity for prostate cancer and continuing to innovate, perhaps around things like imaging, perhaps things like computing power, you know, artificial intelligence, obviously, you know, that will be on the HYDROS system. And I do think longer term, the HYDROS system will be the system that we innovate on. And when we think about new indications, obviously, prostate cancer fits into that bucket.

But HYDROS wasn't necessary for us to continue our exploration of prostate cancer. It just helps, and it gives folks confidence that we now have a platform that we could innovate on to address some of the nuances that are involved with prostate cancer.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay. I'm gonna move on from HYDROS, unless there are any more questions from the audience. Okay. If we could just recap your Q2 results and your guidance for the year. So you talked about a stable to improving hospital capital environment, and you're having more proactive conversations with hospital CFOs. Can you talk about how that's translated to your funnel, and any quantitative detail you can offer on how your funnel has evolved year to date?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, it's. I'm probably gonna disappoint you with my answer, because I'm gonna say it's, it's expanded meaningfully. You know, we haven't given any metrics around our pipeline, in our, in our last few calls, but it definitely gives us a ton of conviction to hit our numbers in 2024 with what we're seeing. We're seeing the new reps that we hired at the end of last year not having any diminishing returns, so to speak, in what they're bringing into the funnel. We're seeing average selling prices in the funnel, significantly improved. I mean, the fact that we're able to continually increase our, our ASP guidance, even prior to Hydros, I think is reflective of the strength and, and demand in our funnel. So we, we feel good about our funnel.

You know, I've been involved in a lot of different capital businesses, and while it's never easy to sell capital, and it's inherently unpredictable. I think at our price point and at our volume of sales in the funnel, we feel very good about our ability to kind of meet what we put out there.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay. You know, just on the capital reps, so you added 10 at the end of last year, and you stand at 40 now, so you haven't really added any more capital reps. On the other hand, you've hired a strategic accounts team. Can you just talk about your capital sales strategy with this new team? And I guess, what is your outlook for further capital rep hires?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, so when we talk about capital reps and the 40, those are quota-carrying capital reps that are focused in certain geographic territories, and we'll continue to add to those folks, I would say, on the margins as we head into 2025. And we think of additions more in, like, the 5 to 15 range. And why we're able to add at such minimal levels is because we've really bolstered this sales force with other types of reps. So for example, we have hired a junior capital rep team, which they may not be mature enough to have detailed conversations with the hospital CEO and CFO, but they can go knock on doors and open up opportunities that, frankly, our capital reps weren't focused on because they were focused much more on a higher-level conversation.

So those farmers, so to speak, have been really helpful to our effort. You also mentioned our key account reps. You know, we've added a strategic accounts team. There's 17 large IDNs in the U.S. that we have contracts with the majority. Those reps are really working from the top down. So while the field team is working bottoms up, the strategic team is really working the top down. They have the relationships with the CEOs and the CFOs of these large IDNs, and you know, we'll continue to add there as well. The additions moving forward are gonna be a little more messy than they've historically been in terms of it's not just a one-for-one capital rep we're gonna add, where we think we can make the biggest impact.

That could be junior reps, it could be strategic account managers, it could be practice development folks, or it could be quota-carrying capital reps.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Are you still thinking about, like, average rep productivity in the five-to-six system range-

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

or can that move up over time?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, I would hope it won't get worse, right? I mean, we, we've always said that we believe, you know, those forty reps on average sell five systems. Now, when you think about where we're at today versus where we were two to three years ago, we would hope, moving forward, that we could see increases in productivity, particularly when we start thinking about a replacement cycle in 2025, when we start thinking about our relationships with these IDNs, where you could see multisystem orders on a per-rep basis. So I think five for now is a good way to look at it, but, you know, over time, you know, we would expect to see improvements here. But the business model itself doesn't need improvements to continue to demonstrate significant operating expense leverage on the sales and marketing line, for sure.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Can you talk about your confidence level in multisystem purchases this year?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah. Look, they're not necessary for us to meet the numbers we put out there. And the multisystem order, on the surface it sounds simple, but it's kind of multifaceted and more complex than that, right? And what we've seen this year, even this year in Q1 and Q2, we have seen multisystem purchases from IDNs. Now, that is being used, those funds. Excuse me, those funds are being generated from corporate, but those deals were already in our funnel. And I think that's what I expect moving forward, is you take deals that are in our funnel that perhaps are being worked at the local hospital level. With the strategic accounts team now, we have the opportunity for corporate to come in and support multiple robots, but those were already in our funnel. I see that as more near-term, tangible, likely to happen.

What I think is a huge opportunity for our company, though, in the outer years, is to work with these IDNs to get commitments as we head into each year for a certain number of systems that corporate will purchase and allocate to their various hospitals. Those aren't factored into our 2024 guidance at all. I don't think they're, frankly, factored into our ability to meet 2025 estimates that are out there. But again, this could be a nice tailwind to the business. And the fact that we even have contracts with the majority of these large IDNs in essentially year three of commercialization, it, it's fairly unusual. I mean, it, it's taken other comparable companies five to 10 years to build these relationships, and, you know, we've been able to do it relatively quickly.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay. In Q1, you placed a single system in an ASC. You know, you talked about that 90% of resective BPH procedures are still done in a hospital setting. But as we kind of think to the future, can you help us understand kind of the benefit to PROCEPT from moving into the ASC setting? I know you have reimbursement here already. Does it maybe help you expand the resective BPH market into, you know, the watchful waiters or the patients on drugs?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, so if we were to pursue an ASC strategy, again, we're early. We're piloting today. We want to make sure we have a protocol in place that gives surgeons confidence that they're gonna have predictable outcomes, just like they do today in the hospital. So in the near term, that methodology is not going to change, and we're going to continue to pilot. We're in no hurry. I mean, the reality is 90% of resective procedures are done in the hospital. We're still very early in cannibalizing that market, and we think we have a ton of opportunity there. And this company would do just fine if we never went into the ASC. With that said, we do think the ASC could be a nice benefit to market expansion, and that's what it would have to be.

We're not interested in moving procedures that would have been done in the hospital to the ASC. I mean, that's a net zero for PROCEPT and frankly, doesn't drive additional procedures. So for us to go to an ASC, we want to be confident that we would see market expansion, and we do think having a procedure that's safe and effective and durable in an ASC setting could potentially get men off the sidelines that otherwise wouldn't get treated, whether that's because they don't want to go to a hospital, whether the surgeon feels more comfortable operating in their surgeon-owned ASC, it to be determined, but you know, we definitely see that trend in healthcare with certain elective procedures.

We're aware of it, and we're fortunate that we have such a safe and effective procedure that's even an option to us, but we're not relying on it in the near term at all.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Do you have a sense of how many Aquablation procedures today have same-day discharge?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, it's an increasing number, and I think on average, you know, we're probably somewhere in the 20-30% range of all patients that we're sending home now, our customers are sending home the same day. With that said, you know, if you go to certain surgeons, we have certain surgeons send 90+% of their patients home the same day. So we do think we have a protocol in place that could lend itself to same-day surgery. But remember, we're not just treating 20- to 40-gram prostates, right? I mean, we're treating all shapes and sizes, and when you get above a certain range, call it 80+, I mean, the reality of that patient going home the same day, it's probably not terribly realistic.

It could happen, but there's always going to be BPH surgeries performed in a hospital, even if we are successful going to an ASC, even if we are successful sending home the majority of patients the same day.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

That's helpful, so you know, your R&D spend increased in Q2. A large part of that was because of HYDROS. Can you talk about, is this kind of the right level of which your R&D is going to stay at?

Kevin Waters
CFO, PROCEPT BioRobotics

There's no way R&D should stay at 30% of sales in the future. That just doesn't work, right? With that said, we're going to continue to invest in our R&D and innovation arm of the company. It's kind of a bedrock of, you know, what we've built here at PROCEPT is to continue to invest in R&D. We spent a significant amount in Q2 that was primarily related to the HYDROS launch. That sequential increase, I think, was $4 million in Q2 versus Q1. That is 90+% HYDROS related. We should see R&D spend in absolute dollars step down about $1 million here in Q3 and Q4. And then longer term, as a percent of sales, we're probably going to settle somewhere in the mid-teen range.

You know, given the type of business we're in and our commitment to kind of innovation here, I don't see us ever being kind of like a high single-digit R&D spender, but we're definitely not going to be 30%, and we'll settle somewhere in that mid-teen range at scale.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Just on utilization. So it will step down in Q3 because, you know, with the rep training for Hydros, but just generally speaking, how are you thinking about utilization growth? Is there, you know, significant room to expand beyond, you know, the average seven per month that you have now?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, I mean, we think there's a ton of opportunity there. The average high-volume hospital does seventeen resective surgeries a month. So in our current installed base today, that would suggest that we're not even yet the standard of care within existing accounts, and we're highly focused on driving that metric. We realize that it is the most sensitive metric in the business. It's the most important metric, frankly, as we move forward, and we think there's a ton of room for upside there, both with our existing surgeons. So you could influence utilization two ways within a hospital. You could have your existing surgeons do more, or you could get more surgeons within a hospital to do aquablation therapy, and we think we could pull on both of those levers.

I think the more near-term tangible lever is to get our existing surgeons to do more. I do think HYDROS, to a certain extent, can help facilitate that to a greater extent than AquaBeam could on its own. So I think that'll be helpful. I mean, the other point that is comforting is, you know, expectations around this business in 2025 don't call for significant increases in utilization. I mean, I think next year is still a year where we're going to be growing the installed base. You know, we've been very consistent in saying those are a natural drag on utilization, and we're going to continue to see that as we place new accounts. It takes roughly three to four quarters for an account, once we ship the unit, to get to the corporate average.

When you add so many new accounts, we're adding roughly 100 new accounts in the back half of 2024, which is roughly 25% of our current installed base. You know, that's a natural headwind to utilization, where many of those accounts don't do any procedures in the month we ship them a device. But we definitely feel there's a lot of room for us to continue to grow utilization, not just up to that 17, but to really, again, ultimately expand the market and have these hospitals doing more surgery than they were doing prior to installing one of our robots.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

If we think about near-term utilization growth, you know, maybe even going into 2025, you know, as your installed base, I guess, of systems, you know, a larger and larger portion of it are older cohorts that started doing Aquablation, who are probably at a much higher level than seven per month, why shouldn't we see utilization growth kind of accelerate into next year?

Kevin Waters
CFO, PROCEPT BioRobotics

I'm not suggesting it shouldn't accelerate. I am suggesting that, you know, we have multiple proof points in 2024 as to what expectations are in 2025, which is comforting, right? And you know, we're not satisfied if utilization was flat year-over-year, and I don't think that's what, you know, folks expect out of this business, and I don't think that's what the market lends itself to. I mean, one of the reasons I feel we've been able to meet our growth objectives is we're operating in such a large market. I mean, we don't spend a lot of time convincing hospital physicians and administrators that there's a large patient population here in BPH. I mean, we're very fortunate that we're operating in a very large market, where our initial strategy is just one of cannibalization.

So I do think utilization is one of those metrics that, again, it's highly sensitive, but we have a lot of proof points now of what good looks like. And, you know, our job, frankly, as a management team, is to go out and replicate what we've done in those high-volume accounts, and if we do that right, we should perform very well.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

And utilization generally has been trending well?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, it's been... I think if you look at it, it's been trending according to our expectations. You know, we've had some quarters that have been stronger than others, right? I mean, we just came off a very robust Q2 of 2024, and frankly, the year-over-year comparable, Q2 of 2023 was fairly weak, right? So some of, you know, that year-over-year growth is really just reflective of a weak Q2 of 2023, not so much kind of any underlying trends in the business. So we are trying to help, you know, all of our investors, you know, really get a handle on what's going on. There's other metrics in the business besides absolute utilization that we're trying to introduce, so, you know, things like surgeon retention, things like number of surgeons per account.

I mean, those are things we're thinking about, how we can be even more transparent than we are to help people understand what's going on with utilization, 'cause it is, we fully admit, it's the most difficult thing to model in a high-growth business, and I feel good about where expectations are moving forward, given what we're seeing in the business today.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay. If we could touch on the prostate cancer opportunity. So you presented early feasibility data at AUA. Can you help frame when we could see final results for the PRCT-002 study and, more importantly, for the larger OUS PRCT-001 trial?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, so just to maybe level set everyone, we have two studies going on today, 001, which is a hundred-patient study that is treating BPH for patients that also have prostate cancer, and then we have 002, which is a twenty to twenty-five-patient study, which is just treating prostate cancer. The patient may or may not have BPH. 001, that type of patient was used to remove the contraindication to treat BPH patients that have prostate cancer, so we did some early work already there. That contraindication was removed by the FDA. And think of that study as just ongoing research, right? We're gonna continue to study patients. You know, this company has a history of being steeped in clinical data, and that 001 is all about gathering data. It's not really for any longer-term objective, 'cause the contraindication is already removed.

I contrast that to 002, which is just treating prostate cancer. So that study is the study where we've committed to give a readout no later than April of 2025, late April or early May, whenever AUA may be in 2025. We expect that to be fully enrolled here by the end of the Q3. We'll be able, at AUA, to give six-month data around both efficacy, we'll be giving data around safety, which is primarily erectile dysfunction and incontinence, and we feel very good, given what we see in treating our BPH patients, with what those primary endpoints could look like. Then longer term, we're gonna have to make a decision at the end of 002. Today, no device out there has an indication to treat prostate cancer.

You know, we will have a fork in the road, so to speak, at the end of 002, where we could decide to commercialize with what's known as a tool claim, which is just to resect tissue, or we could invest further in research, perhaps a randomized controlled trial against something to get in guidelines and to go after our, our own indication for prostate cancer. The nice aspect of cancer is people assume this is kind of a five- to ten-year journey, and while we may follow patients for five to ten years, the reality is the endpoints could be as short as six months, somewhere in the six- to twelve-month range for efficacy, and safety is fairly acute. You know incontinence, you know erectile dysfunction, you know ejaculatory dysfunction, essentially the next week, day, whatever it may be.

So we think we're gonna have some real tangible data in 2025, regardless of kind of what fork we choose in the road, and we think this could be more near-term tangible than maybe some people expect.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Assuming the data is positive-

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, by the way, all of my comments assume that we can show in 002 safety, efficacy with prostate cancer. I mean, that... We wouldn't do anything further, obviously, if we didn't have confidence in those results.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

But assuming the trial is positive, can you just get a tool claim right away and can to generate revenue and while you maybe pursue

Kevin Waters
CFO, PROCEPT BioRobotics

There'd be some work we'd have to do to generate kind of what we would want to see in the tool claim, but definitely the pathway to get a tool claim to resect tissue versus a claim to treat prostate cancer would be the path of least resistance. I think what we're trying to decide as a management team is. Does that really allow us to capitalize on the bigger opportunity that we think is out there if we had our own claim, that nobody has, particularly given the fact this business and the growth of this business isn't dependent on prostate cancer in the near term at all?

I mean, this is, this is all upside, and I think we will have an opportunity to take a step back once we see the data and determine a path that will allow us to keep the bigger picture in mind, which ultimately, I think, will reward people to an outsized impact, as opposed to just trying to get to market too fast. I mean, one of the things we've learned with BPH and our journey is, if you do things right initially, you know, you may have to go a bit slower at the beginning. I mean, we are very controlled with our BPH launch. We're still in every case in the U.S., for example.

We don't need to be in every case, but, you know, we wanna have this controlled launch, to have a great experience, build great key opinion leaders, build a database of clinical data that's superior, and, you know, ultimately, we think that rewards folks to a much greater extent in the outer years.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay. If we could move on to international, I think you've been signaling that, you know, it could, frankly, be a bigger driver for the company moving forward. You talked about investing more heavily in the U.K. I guess, where are you investing in the U.K., and where's the U.K. on the adoption curve, and what is left to be done there to drive further adoption?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, so U.K. is very early. And why we're investing there is we're only going to markets where, one, we think we have a very clear path to become the standard of care, which needs reimbursement support to start with, and two, we're only gonna go deep in markets where we think it doesn't impact the overall profitability of the company, right? I mean, we could be in fifty countries, but if we don't make any money in those countries, it's not really helpful, right? And so therefore, the U.K. is a market with the economics around reimbursement. We get pricing comparable to the U.S. Think of that market as, you know, roughly a fifth, given the population, the size of the U.S., which is still a pretty significant opportunity.

We've invested in a direct sales force there, so we are direct in the UK. It represents... I don't know if I already said this, it represents half of our international sales, roughly, in 2024, and we're very early. I mean, we think this could be a nice opportunity for us longer term. And again, I think we have a very clear pathway there to where we could become the standard of care.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

With the last two minutes, can we touch on Japan? You know, you completed the post-market study. You know, can you talk about, you know, full commercial launch timing? I guess, what are the next steps? And, you know, you need to build out the market there, so how should we think about the ramp once you launch?

Kevin Waters
CFO, PROCEPT BioRobotics

Yeah, so we sold our first two robots in Japan in the Q2.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Okay.

Kevin Waters
CFO, PROCEPT BioRobotics

Like the U.K., this is a market where we received approval. We did a post-market study to receive very adequate reimbursement. So the pricing in Japan is relatively comparable to the U.S. and the U.K., so, you know, we feel like we have a good opportunity there. That model is more of a hybrid model, where we'll have to utilize probably local distributors or sales agents on the capital, but we will want a presence on the clinical side. Again, back to our philosophy of an excellent surgeon and customer experience, we will wanna make sure we're there. So I would view Japan as a hybrid model. That's a market, if folks are familiar with robotics or just any high-end medical device, you know, I think we fit very well in kind of just the paradigm of treatment modalities in Japan.

It's a market with the same significant unmet need that is here in the U.S., and it's also a market that is highly focused on clinical data. And there's numerous medical technologies that have had success in the U.S. based on things outside of clinical data that don't do well in Japan. We're very fortunate that we have great clinical data. It's very well received in Japan. I mean, I think the high-end robotics in Japan are received very well. So this is a market we're gonna make an investment in, along with the U.K. I see those as the two primary growth drivers in the next two to three years, for PROCEPT BioRobotics.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

Great. And with that, I think it's our time.

Kevin Waters
CFO, PROCEPT BioRobotics

Great.

Nathan Trebeck
Medical Device Analyst, Wells Fargo

So Kevin, thank you so much for coming in.

Kevin Waters
CFO, PROCEPT BioRobotics

Thank you very much. Appreciate it. Thank you, Aroo. Appreciate it.

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