Hi, everybody.
Morning, Lee.
Lee Hambright, U.S. MedTech Analyst at Bernstein. We're very pleased to kick off the Strategic Decisions Conference again with Boston Scientific. We've got Mike Mahoney, Chairman and CEO, and Ken Stein, Chief Medical Officer. Thanks so much, guys, for being here.
Thank you for having us.
For those of you in the audience, if you have questions, you can enter them in the Pigeonhole tool. I will try to work in as many as I can. Mike, kicking off, you're in your 15th year at Boston Scientific, and you've transformed the company from flattish growth when you joined to 16% organic growth over the past couple of years. 2026 is a little bit of a transition year. Maybe you could kick us off with a few thoughts on the state of the business.
Sure. Good morning. Thanks for coming, everybody. As you said, we're very proud of the company, what we've built over the years, the markets that we're competing in. We think we still compete in markets that grow at least 8%, as we said at our investor day last year. We've really positioned ourselves in the right growth markets. You've seen some recent announcements with the Penumbra shareholder vote and investment in MiRus and other investments. We really invest for the company to be differentiated for the long term. Proud of the results the last couple of years. This year's been a bit more of a challenge than we anticipated. As you know, unfortunately, we did take our guide down earlier in the year to 6.5%-8% for full year.
At those levels, 5%-7% for second quarter, 6.5%-8% for the full year. We're comfortable within those guidance ranges for the second quarter and for the full year, and we continue to invest for the future across our businesses. Our goal always is to grow faster than our WAMGR, to drive double-digit EPS growth, to improve margins every year, which we've done every year. With that guide that we said, we're still comfortable that we can deliver the margin improvement in the EPS goals that investors expect as we invest for the future and to get back to differentiated growth profile.
Great. Okay. Maybe you could just comment a little bit on the health of underlying markets. There's been some questions about utilization trends and potential headwinds from Medicaid cuts or expiration of the ACA exchange subsidies. What are you seeing in terms of just general market trends?
In the markets that we're in, we don't see any slowdowns or significant impact by those events. We have actually seen a bit of an increase in backlog with WATCHMAN, which we'll talk further on. We see healthy volumes in EP, healthy volumes across advanced cardiology. We haven't seen a slowdown in the overall procedure mix and rate globally for Boston.
Yeah. Great. Okay. As you mentioned, you're guiding to 5%-7% organic growth for Q2, 6.5%-8% for the fiscal year. You took the guidance down, as you said. I know you don't take that lightly. What changed from early February to late April? What's your level of confidence in those growth ranges today?
Yeah. As I said, we're comfortable within the guidance range for 2Q and full year. The three impacts that we saw that were a bit unanticipated, the first one that was the largest unanticipated one, really is WATCHMAN. We are the 91% share leader in WATCHMAN. We do have another competitor, but we're primarily the market at this point in time. We're coming off multiple years, in 2025 of, I think it's about 30% growth or so and tremendous growth in concomitant. What we've seen with the post earnings call is a decline in standalone WATCHMAN growth and increase in concomitant growth. We've taken our number down in WATCHMAN internally to match that guide. We obviously aim to cure that over time. We'll talk more about that. The second area is EP. Our EP business, really proud of what we've done.
We went from a distant fourth place, really non-player in EP, to a strong number two globally. We expect to continue to be the PFA market share leader. We have some really robust launches I'm sure we'll get into coming up here. Essentially, we provided more space for some additional market share reduction as competitors continued to launch. We're seeing that now, we took our guide down a bit in EP. The third primary one is urology. We're the number one global share leader in urology. We saw some softness in our performance in that area. Really a combination of those three things, we felt it was prudent to take the guide down.
Got you. Okay, great. We'll dig into all this. Consensus growth forecasts have reset to around 8.5% for fiscal 2027 and 2028. I don't know if you're ready to comment on those at this point, but I wonder if you could just help us think about the key drivers across the company that are accelerating or decelerating into 2027.
Yeah. We'll provide an update on our three-year LRP, likely after the third quarter earnings call. We're not going to give any numbers on 2027 or 2028. Our business is all about our people and our portfolio. We have a lot of super exciting portfolio initiatives happening in those time periods. We'll talk about EP quite a bit. We have our next gen FARAPULSE Ultra product coming out. We have a FARAPOINT product now. We'll enter the ICE market. We'll start our IDE with FARAFLEX. We really expect to expand the scope of procedures we are in EP. That market's growing very healthy, and we expect to maintain PFA leadership and get back to share taking over that time period. A lot of key launches there. We'll also launch the next generation WATCHMAN platform in that area.
I think the biggest business impact you'll see besides ongoing discussion on EP and WATCHMAN, as you look to the future, really is across our interventional cardiology, vascular, and assuming Penumbra closes, the combination of those businesses will be very powerful for the interventional cardiologist, vascular surgeon, interventional radiologist. We have a lot of launches to compete in the IVL offering, which will start in 2027. In coronary, you saw the PCR, the FRACTURE results, which is really encouraging. We expect to have big years with FRACTURE. We've got a differentiated hypertension device that we expect to be launching in 2028. We invest a lot in circulatory support for high-risk PCI and shock. We have the Penumbra acquisition in the future. You saw a recent investment that we've made in MiRus to enter the TAVR space. There's a lot of significant growth drivers in that time period.
Excellent. Okay, one last one before we get into the businesses. Boston Scientific can be a little bit intimidating for generalist investors. You've got a lot of products. Maybe for the generalists in the audience, how do you simplify Boston Sci, simplify the story, explain what's different about you versus your med tech peers?
Sure. I think it's a great company. I'm biased. We're primarily an interventional medicine company, so the vast majority of our products are procedures that are done where patients in and out of the hospital or the surgery center the same day. We really disrupt a lot of the former surgical procedures. The makeup of the company is 8 business units. Think of 5 of them in cardiology, including oncology, and then 3 of them MedSurg. What we try to do for many, many years is a combination of our internal organic R&D, which we invest about a little over 9% in. We've got the largest venture fund in MedTech. We leverage that capability, and we acquire companies and invest in companies from the venture portfolio, and we are pretty active in M&A.
The combination of those three things we use to fill in any product gaps and to move into higher growth markets, but all within a common call point. We call that category leadership. If you're a urologist, we want to have the widest portfolio covering urology groups and differentiated technology. That's the same thing whether you're in endoscopy, neuromodulation, or our cardiology divisions. We really try to provide a suite of products across that call point and with differentiation in there. We continue to find faster growth markets that leverage those call points. That's why our WAMGR consistently grows over many, many years.
Yeah. Great. Okay. Excellent. Let's get into WATCHMAN. Mike, on the Q1 call, you touched on several factors that might be contributing to the decelerating growth for standalone WATCHMAN. Are you still seeing that deceleration, and can you share your latest thinking on what's driving that trend?
Yeah, it's been a challenge for us because, as I said, we're really about a 90%, 91% market share leader in that area. We're coming off about a 30% growth rate, and we're very excited. Ken can talk about our CHAMPION-AF results, which was a significant trial, which we think over time will give us a label change and hopefully over time, a reimbursement. It will also triple the size of the market. It's a very important trial that we're very pleased with the results there. What's happened in 2026 is we've seen a declining usage of WATCHMAN standalone procedures, and we've seen an increase in concomitant procedures. The good news is the concomitant continues to grow, and that's where we have our FARAPULSE and our WATCHMAN combination. Based on OPTION, CHAMPION-AF continues to go up.
The issue we're seeing, where we're seeing a continued declining trend, is in standalone WATCHMAN and across the interventional cardiologists and the EP. Part of it is workflow-oriented, where EPs are very, very busy with ablation. Now they're doing more and more concomitant, and as a result, so far, they're doing less standalone procedures in a week. We need to get back to standalone WATCHMAN days for EPs, and we've seen a decrease in standalone procedures for the interventional cardiologists. They may not be seeing as many referrals. There's some other structural options out there, and so we are re-engaging the interventional cardiologists with more dedicated, focused specialists in the field, more MedEd events.
As a result, with the declining standalone WATCHMAN and growing concomitant, we basically want to set an expectation of flat dollar growth from first quarter to second quarter, and likely into third quarter, given the dollar sequential comps in those quarters. We're comfortable with our second quarter guidance within that range and for the full-year guidance within the range with that WATCHMAN slowdown in the standalone.
Got it. Okay. I know you've cranked up commercial intensity, as you said, on interventional cardiologists to get the focus back to standalone WATCHMAN procedures. What are the key messages you're working to get across at this point, and what kind of reception are you getting there?
Do you want to highlight CHAMPION-AF there?
Yeah, why don't I take that? I think we are still very firm believers in the strength of clinical evidence and as a result, the long-term health of this market. Again, the things that Mike talked about we do think are all transitory, right? Again, it's issues to date in terms of just operational issues and operationalizing concomitant procedures. We do believe that there are fixes to that. We do need to get more folks trained in doing WATCHMAN. We see a lot of demand for training at this point from folks who haven't been doing procedures previously. The thing that drives that strength and that demand, and we still really do see very robust demand from patients for this procedure, is data from trials like OPTION, like CHAMPION-AF.
These trials do prove, I think to everyone's satisfaction, in the implanted community and in the referring community, that WATCHMAN is a reasonable alternative to lifelong blood thinners for patients who are at high risk of stroke, that it provides equivalent or near equivalent protection from stroke with a much lower risk of clinically important bleeding. The one headline number from CHAMPION that I don't think people have given enough attention yet, actually, it doesn't come from the WATCHMAN results. It's the blood thinner results. This is a group of patients who were picked because they were believed to be low risk of bleeding, great candidates for being on blood thinning medications. All right? One in five of those patients have a clinically significant bleeding event within three years. All right?
We talk a lot about the opportunity for indication expansion, but even if we look within the existing indication, this therapy is still under-penetrated, and there's still a lot of patients out there who just can't tolerate these medications over the long run.
Yeah. Got it. Excellent. Ken, I know you talked about hospital capacity as one of the headwinds that you mentioned related to slower standalone WATCHMAN. Edwards ran into a capacity issue a while back, and it took them three quarters or so to bounce back. Is that the right expectation here? Can you just talk a little bit more about the capacity issues?
Yeah. I don't know that I'd compare one versus the other. It's a bit of apples and oranges. Very different kind of set of procedures. I think what is fair to say are again, first of all, doing concomitant procedures does raise a host of operational challenges that frankly, hospitals, cath labs, hadn't had to confront before.
People are just still thinking through how do we do these procedures together. We love concomitant FARAWATCH procedures because both FARAWAVE and WATCHMAN together give us a fantastic protection around that procedure. If you're going to do that procedure, you want to do it with the fastest, safest, most reliable technique. That's both FARAPULSE for the ablation part of the procedure and WATCHMAN for the left atrial appendage closure part of the procedure. It does complicate scheduling.
All right? We are now working with hospitals. How do we unlock that? Right? What can we do to improve the operational efficiency of the concomitant procedure? The other thing that we are dealing with right now is there's competition for space, not just doing WATCHMAN, but the other kinds of procedures that are done in those labs. For electrophysiologists, that's ablation. We are still seeing robust growth in the AF ablation market. One of the safety values for that i s the move for the more simple ablation procedures into the ASC, ambulatory surgical center.
That'll take time to play out. I think the key message here, right, is that's not going to be an overnight solution to any of this. This does take years to play through. As well as, right, taking years to play through getting better representation of guidelines based on CHAMPION-AF results and OPTION, getting better or revision of the National Coverage Determination in the U.S. for payment for procedures. I think that's why what Jared might say is, again, it's going to have that deceleration over the short term, but that's why we're still confident over the long run in this return to a very fast-growing market.
Yeah. Excellent. Okay. How much pushback are you getting regarding CLOSURE-AF data, and do you think your key messages on CHAMPION-AF are kind of fully offsetting that pressure?
Yeah, I think CLOSURE is a difficult study. It did get published in The New England Journal of Medicine a week ahead of Champion. That did have some impact, and frankly, more impact than I had expected based on the quality of that data and based on what's actually in that data. The other thing that hit us is WATCHMAN has always been polarizing. There's a very small but very vocal group of people out there who are WATCHMAN haters. They were out trashing Champion even before the data were out. Whereas, we had our hands tied behind our back. We couldn't pre-promote the data. We couldn't talk about the results until the data were out there. All right? Now we are out educating people.
When you educate people about CLOSURE, right, again, CLOSURE, fewer than half of the devices in that trial were WATCHMAN FLX. It was mostly done with legacy devices and with competitive devices. In spite of that, it actually showed equivalent protection from stroke in a very high-risk group of patients. Trial failed because they had bleeding events and procedural complication rates that are a literal log order of magnitude higher than what we see with WATCHMAN FLX, and what we actually saw and published in CHAMPION.
Again, I think we have confidence that we can get out there now and through our professional education events, through our marketing, get out there and combat this narrative around CLOSURE and get people to focus on what's really important, which is right, there are patients out there who are at high risk of stroke, who have a very high rate of clinically important bleeding when they're treated with blood thinners. And they can be managed very safely, very effectively with WATCHMAN.
Got it. Can you just talk about the timelines? Have you submitted Champion to the FDA? Can you give your just latest thoughts on timing for label expansion and guideline updates, changes to NCD?
We have submitted to the FDA. If you figure, call it 9-12 months. When you have that PMA supplement to get approval, that's a reasonable timeline to expect. Again, based on the strength of the data, we are confident that we will get that label update. Guidelines probably work out in parallel. The guideline process is a very slow and bureaucratic and cumbersome one, but we have been talking to the societies. The last step in that unlock is getting CMS to revise the National Coverage Determination. We won't approach them about that formally until we have the label update.
Yeah. Got it. Okay. Maybe wrapping up on WATCHMAN. You've got over 90% share, as you mentioned, in left atrial appendage closure, but you do have a competitor coming with a next-gen product next year. Also, some investors worry about next-gen anticoagulants. What's your level of confidence in the market kind of getting back to 20% plus growth?
Yeah. Again, based on the strength of data from trials like CHAMPION, we do believe that in the long run, we can get back to that kind of hyper-growth, if you will. Having a competitor, it raises challenges, but frankly, it also helps sometimes in terms of getting the messaging out there about the utility of this kind of therapy. Likewise, I know there are folks out there concerned about the next generation of blood-thinning medications, the so-called Factor XI inhibitors. There have been two oral agents that have been studied. One was studied for this indication, stroke reduction in atrial fibrillation, and failed.
I don't think there's any guarantee that the other agent is actually going to pass its trial. Even if it does, I think, A, it raises the awareness around the importance of bleeding reduction in terms of addressing patients with AFib who are at high risk of stroke. Depending on where those things get priced, are those just going to be used as second-line agents in patients who fail oral anticoagulants? If so, there are still a lot of patients out there who would prefer a one-and-done approach as opposed to taking a lifelong of drugs that still have a risk of bleeding, that are still expensive. If you're a 60-year-old with atrial fibrillation, you're talking about taking these kinds of pills for 20, 30, 40 years. Do you really want that?
Yeah. Got you. Okay, great. Let's move to EP. Maybe starting with Mike, you've got a vision of the world where PFA becomes the dominant energy source. Yet there's been some pretty strong interest in dual energy catheters in the early days. How do you compete with dual energy catheters? Does FARAPOINT fill that gap?
Yeah. We think PFA clearly has become the market-leading therapeutic catheter. The estimated utilization in the U.S. probably likely close to 70% last year, probably approaching 80% this year. I think that race has kind of been won by PFA. Outside the U.S., it's not quite as high as that, maybe 50%, and very low penetration so far in China, which we're working on as well as other companies are. In Japan, similar, a little bit less than U.S., high numbers. We think PFA will continue to expand. Our key for Boston is to expand our portfolio to really be the PFA choice for across all the different clinical needs based on the FARAPOINT product that we have. We have a next-gen FARAPULSE Ultra coming, then we have a FARAFLEX, which we expect to be in IDE this year.
Our goal is to continue to broaden the portfolio, I think you'll continue to see a PFA usage continue to increase that utilization. Will it get over to 90%? I'm not sure. At least 80% likely by the end of this year or in 2027.
Yeah. Okay. Got it.
Maybe just to add to, again, when Mike ran through that list of catheters, and so our focus is on continuing to have the world's best portfolio of PFA catheters. We're starting to see now with some of our competitors, as they're getting more clinical use, there are issues that can arise with trying to push RF onto a catheter that's designed to be a PFA catheter. Likewise, we've seen with competitors issues when they take a catheter that was designed to be an RF catheter and try to push PFA through it. Just remind everyone, all PFA is not created equal. Getting safe and durably effective results require a combination of optimizing the waveform, optimizing the catheter design, and optimizing the recipe, just the actual where do you deliver lesions and how many do you deliver. We are laser-focused on all three of those in terms of evolving our PFA catheter portfolio.
Excellent. Okay. You've got a competitor who's in the early days of a single-shot balloon catheter launch in the U.S. There's also some upstart nanosecond PFA technologies we hear about sometimes. How do you think about the competitive environment and how it evolves in the PFA space?
It's certainly a challenging competitive environment. I think everyone here who's following this space recognizes that. In terms of the balloon catheter, one of the things that's been one of the big advantages of the FARAPULSE platform has been its versatility. The ability to use FARAPULSE not just for pulmonary vein isolation, but for doing other lesions, particularly putting lesions in on the back wall, posterior wall of the left atrium. Balloon catheters just intrinsically don't have that degree of flexibility. In Europe, where that catheter has been available for some time now, we really still do see continued robust usage of FARAPULSE. In terms of some of the other novel technologies out there, you can imagine we remain very engaged as we look at our business development opportunities.
Mike mentioned our VC portfolio, but we also have a lot of internal expertise at this point in how do you optimize waveforms for getting the best possible results with any individual catheter form factor. It's an advantage that we have, that first-mover advantage, the huge number of patients who've already been treated with the FARAPULSE system. We've got a lot of internal knowledge now that we think puts us in pretty good shape versus some of these startups.
Great. Okay. How important is integrated imaging and mapping, and can you just remind us where you are with new launches on that front?
It's very important. We've said for a number of years. We've really built up a significant presence around the world with our mapping capability with OPAL. Every quarter, we're placing more and more OPAL units. Every quarter, we're having higher certification levels of our mappers. That momentum continues to build and continues to be our focus. As we continue to broaden the portfolio, as Ken talked about with our FARAPOINT launch we have now, with integrated ICE, with FARAPULSE Ultra, and with Flex, you broaden the portfolio mix of procedures you can do in that lab beyond PVI and posterior wall, which is a great place to start from with a market share leader. As you continue to broaden the portfolio, you continue to enhance the mapping capability.
You continue to extend the type of procedures you can do, and you develop strong relationships in the lab. We put significant investment in the U.S., Japan, and China, all over Europe. Every quarter, we launch more OPAL mapping systems. Every quarter, we advance our software. Every quarter, we advance our pipeline. We're really proud of our market share position today and feel like the mapping component is as important as our therapeutic catheter cadence that we have.
Great. When does ASC start to move the needle?
It's going to be small numbers. What would we say? 10%-15%, Lauren, over maybe two years of the AF ablations. You're seeing some activity now for sure.
Yeah.
Obviously in the U.S. and certain states that allow for Certificate of Need or reimbursement. You're seeing some activity now, contracts being written, and that will help some of the workflow issues or items or opportunities I should say that Ken outlined and we discussed earlier. You'll see more and more of that in 2026, 2027, 2028. We estimate maybe 10%-15% of the market.
Yeah. Got it. Okay. Mike, maybe punchline on EP, what's your level of confidence that this is a low year for Boston Scientific EP growth? Can you get back to a share taking position in 2027?
Well, that's obviously our goal. This year as the PFA leader, we have lost some market share as competitors are launching, and the whole key there is the cadence of portfolio that we have, that we've outlined. As you continue to extend out into 2027, 2028, 2029, that portfolio comes through, and you have increased scale of mappings. We're quite comfortable that we'll continue to be the PFA market share leader as we continue. I think the R&D teams have done an excellent job in that area. We know all the startups you're talking about. We have a lot of confidence in our pipeline and the momentum that we have.
Great. Okay. Let me just touch on urology. Urology organic growth has decelerated for three quarters in a row. I know you've got a lot going on there. What gives you confidence that Q1 was kind of the trough there and that things are looking up from here?
Yeah, urology is a really nice business for us. It's traditionally been a 7%-8% grower. We think the market grows 7%. We're not used to growing below market in that category. We will this year. We're fixing a couple specific areas, one in our CorStone portfolio, where we've seen some niche competitors come in, and sometimes they're price competitors, and we aim to fill some product gaps with pressure sensing and suction and other improvements to our CorStone portfolio. One's been launched recently, you'll see a cadence of launches over the next nine months to really improve our performance in CorStone. The second big area has been Axonics, a really nice technology to treat overactive bladder for women. We had a lot of commercial disruption in that category.
You need highly trained clinical reps and sales reps to implement that strategy. We've hired about 100 of them. They continue to become trained and will improve the performance of Axonics as we go throughout the year. We're comfortable that urology won't be back to market growth this year but should improve from that first-quarter performance.
Okay. Great. Let's touch on TAVR. You've had a couple of high-profile disappointments in the TAVR space. Strategically, why do you need to be in the TAVR market, and what did you learn from Lotus and ACURATE?
Well, we've learned a lot from Lotus and ACURATE, but we also learned a lot from our EP days. They weren't maybe as big, but we had two big failures in EP before we found Farapulse.
Yeah.
FARAPULSE really changed the game for EP. With TAVR, it's a fantastic market with Mitral and Tricuspid as well. That is one large competitor. We've stayed all along that we wouldn't want to enter the TAVR market unless it was a balloon-expandable, unless we had the potential to disrupt, similar to how FARAPULSE has disrupted a very big, mature, where there was a clear dominant market leader in EP. We see similar traits to what's happened with FARAPULSE and EP with TAVR. To find that product that's differentiated is hard to do.
We've had two whiffs at it with Lotus and ACURATE. We've been following MiRus for many, many years. It's a very unique company. It's got a special alloy called rhenium, and he was very smart and playing for the long term and created a spine company leveraging this material to prove to the FDA the capabilities of this new metal alloy, all with the goal of creating a disruptive TAVR company. We've known the company for quite a while. Our competitors have known the company. There was really outstanding clinical results early on, and now they're approved for all three sizes and all three risk indications and enrolling a clinical trial now. We see MiRus with the potential to really disrupt what is a very large, fast-growing market that's right in our wheelhouse in cardiology.
Great. Ken, maybe when that Seagull valve does come to the market in late 2028, early 2029, it will have been over 20 years since TAVR was first approved in Europe. Clinicians are obviously increasingly focused on durability. How can you compete on durability with limited data at launch?
Yeah, I think we'll just come back to what the advantages are of the Seagull valve, and that's the valve that MiRus is developing. Of course, this all does need to get proven in the clinical trial that is currently enrolling. Using the rhenium alloy, this is not just evolutionary. This is a truly revolutionary step change in these valves. The alloy gives you a huge number of advantages based on its durability as a metal and its strength. To begin with, this valve is dramatically a smaller profile than are the conventional valves, whether it's Edwards, whether it's Medtronic. This is delivered via an 8 French system, whereas today's conventional valves are 14 French or higher. One of the huge issues you have today with TAVR are vascular complications. You can anticipate that with smaller size.
You have to end up with a lower rate of vascular complications, better ability to deliver the valve through tortuous anatomy. In addition, the valve doesn't foreshorten when you expand. What happens with today's valves is they shrink down a little bit when you expand the valve. Makes placement a lot more difficult. As an operator, you can be much more precise with the implantation of this valve. Because of the strength of the rhenium alloy, you have much better concentricity and cylindricity of the valve. We do believe that the valve, as a result, will have much, clinically importantly, lower valve gradients, so less obstruction to flow through the valve. We believe because of all of these factors, that there'll be a lower rate of permanent pacemaker implantation.
We're talking about a valve that, based on its design, we anticipate will be easier to implant, will be associated with a lower risk of operative complications, and will be associated with better hemodynamic results over the long term. It gets back to what Mike was saying. This is, again, not just a small evolutionary change or a me-too valve. This is something that's just dramatically different and tangible differences that'll be obvious to operators and have been obvious to operators who've participated in the clinical trials from day one. Again, established competitors, it takes time to displace them. With that long laundry list of advantages, we're extremely optimistic about this valve.
Okay, great. Maybe just one quick word on the clinical trial, the STAR pivotal trial. 1,000 patients head-to-head, powered for non-inferiority. It's got secondary endpoints on vascular complications and hemodynamics, as you mentioned. What data do you need to see from that trial to give you confidence that the valve can compete?
I think, again, the key is being able to show the non-inferiority and being able to get labeling approval. With that, again, the folks who've handled this valve, the advantages are just so-- I'm trying to think of a nice way of saying this, but they are just blindingly obvious, right? There are very few things that substitute for operator experience, putting in something or using something. The operator experience using the Seagull valve is a step change versus using today's incumbent technologies.
Great. Okay, excellent. Let's talk about some other drivers across the business. Mike, the ICVT business was very strong in Q1. Can you just talk a little bit about the outlook for that business?
It's very strong. Really impressed with what that team has done. They continue to really enhance that portfolio globally. It's one of our second largest business behind EP and growing at a very high growth rate now, really being led by the whole strategy is see, prep, and treat. Our see piece of this is our IVUS imaging. You're seeing imaging, which is very strong in Japan and in Asia, really becoming dominant modality in Europe and the U.S. now and continuing to grow. We're the market leader in IVUS. We continue to roll out new capabilities with IVUS, leveraging AI capabilities to improve the efficiency of the lab and the precision of the physician.
The treat components, we have multiple products in that area, we're excited about the recent FRACTURE IDE news and the launch of our SEISMIQ platform for IVL in 2027. The treat piece of it, we have obviously a number of stents and various products, but our AGENT Drug-Coated Balloon is performing extremely well. We're the market share leader there, and we have what's called the STANCE trial to widen the indication for the balloon capabilities. We have so many products further out in that pipeline. As we mentioned before, with hypertension, the Penumbra post-closing will fall under that business. Our Silk Road acquisition has done extremely well within our vascular business. We've got a number of pipeline products in that area.
I really think beyond the ongoing EP, which is a great market, and we tend to continue to be the market share leader with that cadence. We'll work through the workflow issues with WATCHMAN and expand that market indication, get the labeling done, and get back that to growth. That whole combination of ICVT, not a great name, really will be, I think, a unique growth driver for the company across that comprehensive portfolio for many years to come.
Great. Let's just touch on CRM for a sec.
The Seagull valve will also fall under that over time.
Of course. Got you. CRM growth was negative in Q1. How do you get back to growth in CRM?
CRM's been a tough one for us. Our challenge has been we've got a strong core defib pacemaker portfolio. We've got an important launch called Denali, which is a whole new platform for core defib CRT-D pacing that would be coming out into kind of 2027, 2028 time period, along with S-ICD. That should revitalize that group better than it has performed, better than it has been historically. Our gap continues to be in leadless, which is the higher growth area. We do have our paired leadless program with S-ICD, which should launch in 2027. That should improve it. We're not going to likely grow faster than our peer group in the short term. As that Denali platform gets launched in our emblem with the S-ICD leadless pacemaker, that will help our growth in our CRM business.
Okay, great.
Kenneth Stein, anything else in that area?
No.
Got it. Great. Let's touch on Penumbra. What do you like about neurovascular and peripheral vascular spaces, and how are Penumbra's platforms differentiated versus key competitors?
Well, we like the peripheral vascular space. We're likely the number 1 player in that business now. We just don't have a mechanical thrombectomy solution. Years ago we got rid of our neurovascular business, which was crazy. We've always liked neurovascular. Those are the two areas that were really big growth markets that have WAMGRs, that are accretive, at least on the thrombectomy side, to Boston Scientific, which is hard to do at that at least 8% growth. Penumbra is a gem of a company. They're really very high strong share position in thrombectomy, high strong share position in neurovascular, very exciting pipeline of products that you're aware of that are coming through, hopefully by the end of this year, in 2027. Really fills two gaps in our portfolio in peripheral vascular that we didn't have.
We have Silk Road, a nice acquisition for vascular surgeons. It's two big categories that have great WAMGRs that we did not have a presence in. It fills that strategic niche very well. It's an excellent company, a very strong scaled commercial force. We'll run it as a standalone business within Boston Scientific under Lance Bates, who runs that ICVT area. Our aim is to retain that commercial team, retain that R&D team, and let them continue to run, but drive appropriate commercial capabilities across that wide portfolio of products.
Great. How are you feeling about the regulatory process and kind of just confidence in closing everything on track?
We just had the shareholder vote. That went well. We said second half 2026. We're kind of proceeding as planned.
Great. Okay. At $15 billion, this was obviously a larger deal than the tuck-ins that we're used to seeing from Boston Sci. Skeptics have keyed in on the timing as EP and WATCHMAN are decelerating. What do you say to investors who worry that the deal was maybe defensive or too big?
We've liked Penumbra for years. The timing worked out, with Adam and the team, when we announced it this year. That would've been an acquisition we would've done three years ago, or we'd do two years from now if we could do it. It made a lot of sense for the reasons I said earlier. On the strategic side, on the portfolio, it's an increase in growth rate for the company. We'll be able to drive capabilities around the globe that they lack in Europe and Asia Pac, and we'll be able to drive some better operational synergies in the supply chain and manufacturing. That deal just made a lot of sense for us. The financial returns are healthy, and the timing worked out when it did.
Great. Okay. Before we zoom out a little bit, just a question from the audience, just a clarification. I think you mentioned earlier expectations for WATCHMAN around Q2, Q3. Can you just clarify a little bit what you meant there? Just a flat dollar?
What I mentioned is we've seen the declining standalone WATCHMAN, and we're being as forthcoming as we can sharing what we're seeing. We're learning a little bit from what happened in January in EP. We've seen a declining standalone growth rate increasing concomitant. What I mentioned is we expect to see second quarter dollars in WATCHMAN similar to first quarter dollars. We had very strong sequential growth in 2025 in 2Q and third quarter. We expect to essentially see flat dollar growth in 2Q and 3Q with WATCHMAN. With that guide, with that information, we're comfortable within our second quarter guidance range and our full-year guidance range.
Yeah. Got it. Okay.
If it gets better than that.
Yeah
There's more upside. What we want to do is say, based on the downward trend we're seeing in standalone, and we have all these initiatives with label changing, all the MedEd events, all the educational events to improve standalone. Assuming standalone doesn't get better and the sequential growth, dollar growth stays the same, that's what we're mentioning here in second quarter and third quarter, and with that framework, we're comfortable within the guidelines of our second quarter and full-year guide.
That means global WATCHMAN revenue in Q2, Q3 kind of flat to where it was in Q1?
Correct.
All right.
On a dollar basis.
US.
US.
Sorry, U.S.
Well, U.S. is 90% of it.
U.S. flat Q1. Okay, got it. Q1 to Q2, Q3. Okay. Zooming out, you announced a $2 billion ASR last week. You've got $3 billion left on authorization. How are you thinking about additional buyback opportunities? What's the max leverage you'd be willing to take on?
Yeah, we're happy we're doing the $2 billion ASR given where share price is trading and based on the strength of the growth profile of the company as you look to the future for Boston Scientific, as we outlined before with our portfolio. We think, at this valuation, which we haven't done share repo in a while, we think it makes a lot of sense. We think $2 billion is the right number. When we close Penumbra, our goal is to stay at that A-minus level. We'll stretch to a little bit above 3 times on our debt ratio, and then we'll continue to de-lever from there and kind of get back to that 2.25-2.5 range.
Got it. Okay. As we all turn our attention to Q2, and the organic growth range of five to seven, can you talk just a little bit about the key swing factors that could take it to the high end or the low end of that Q2 range?
It's not too far away. As I said, we're comfortable within the guidance range there. We've assumed in that range, as I mentioned, the sequential same dollars from first quarter, second quarter in WATCHMAN, which is a change, but was contemplated in our guide just to be appropriately safe. As you look at that full-year guide, it's the same big levers we've said before, is continuing with our EP momentum primarily on the pipeline initiatives we have in the mapping. I gave you the WATCHMAN comments. As we expect, we continue to see strength in interventional cardiology and vascular. Those are really the upsides, downsides of it. In essence, we're comfortable within those ranges.
Got it. Okay. Can you talk a little bit about M&A? You did Penumbra. It was a little bit bigger deal. Axonics was a bigger deal. Should we expect that to be more of the trend going forward? Should we expect you to get back to sort of?
I don't think that'll be the trend going forward. I think there's very few Penumbras out there with companies that have that strong market share position, high growth rate, high WAMGRs, and that had that really beautiful strategic fit with Boston Scientific. There's very few assets out there, and so we like Penumbra a lot. We made a big bet with MiRus because it's transformational, and we think it could be the Farapulse of TAVR in terms of its potential capabilities. You won't see bets as big as Penumbra in the near future. One, because of the radiance that we want to have and so forth, also a scarcity of assets. I would say more traditional Boston Scientific tech and M&A.
Yeah. Great. As you think about focus areas for those types of deals, focus areas for venture investments.
Well, there's a lot of them. We have about almost 50 companies in our venture portfolio. We've been very active off of those. They're across maybe weighted about 80% to cardiovascular broadly and 20% to med surg. We have a number of assets in that area that we like a lot.
Okay. There was a question from the crowd on mitral and tricuspid, maybe related to MiRus. Can you just talk a little bit about what you've got in the hopper there?
Yeah, we are excited about our bets in that area. We think it's important that you have to have a foundational, potentially meaningfully disruptive TAVR valve as the anchor product, and we think we have that with MiRus. We have to prove it through the clinical, but we're incredibly bullish on the potential with that. With that as the likely foundation, it wouldn't make sense to add mitral and tricuspid. We have a number of venture bets in that area, and also the team at MiRus is also creating tricuspid and mitral platforms leveraging that same alloy.
Great. Okay. Maybe thinking longer term, you've repositioned that 10% plus organic growth as kind of an upside case over the 2026 to 2028 time frame, but you're sticking to those op margin expansion goals. What's the right way to think about Boston Scientific over the next few years?
Well, I would say short term, kind of that 6.5%-8% is our full-year guide. We've improved margins every year for 14 years in a row. I think we've delivered double-digit EPS almost every single year. That will be our continued goal this year, to hit that double-digit EPS growth and improve margins with that full-year guide. As you look at the future of the company, it's all on this innovation pipeline. Improving share in EP, addressing this WATCHMAN, call it workflow issues, as we widen the patient indication for that and continue to have clear market leadership at WATCHMAN. Really building off that ICVT portfolio we talked about, then strengthening our businesses in med surg. Neuromod is doing very well this year. We'll continue to expect them to grow nicely above market.
Endoscopy will have a solid year this year and improve our urology business. I think strengthening of the overall MedSurg business, but very unique growth drivers across cardiology that position the company for unique growth in the long run. We always continue to improve margins and drive double-digit EPS based on our track record.
Great. Okay. Maybe wrapping up, MedTech stocks have pulled back. Boston's trading at a significant discount to historical multiples. What final thought do you want to leave investors with here?
Well, that's why we did the share repo. I think if you look at MedTech, you ask about procedure volume. It's basic stuff. There's an aging population. These are less invasive procedures that have a massive impact on sustaining lives or improving lives across our businesses. The volume is there, and the innovation cycle that we have for the future is very, very robust, and we have a very disciplined company when it comes to improving margins and driving EPS growth. Like any cycles, MedTech as a sector is below the S&P quite a bit this year, where it hasn't been for many years prior. Our job at Boston is to continue to drive performance this year and to invest for the future, deliver long term, and over time, the sector performance should improve.
Great. All right. We're out of time.
Thank you, Lee.
Thanks for being here, guys. Appreciate it.