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Good morning, and welcome to the Boston Scientific First Quarter 2026 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Lauren Tengler, Vice President, Investor Relations. Please go ahead.

Thank you, Bailey. Thanks to everyone for joining us. With me today are Mike Mahoney, Chairman and Chief Executive Officer, Jon Monson, Executive Vice President and Chief Financial Officer. During the Q&A session, Mike and Jon will be joined by our Chief Medical Officer, Dr. Ken Stein. We issued a press release earlier this morning announcing our Q1 2026 results, which included reconciliations of the non-GAAP measures used in this release. The release, as well as reconciliations of non-GAAP measures used in today's call, can be found on the investor relations section of the website. Please note that on the call, operational revenue excludes the impact of foreign currency fluctuations, and organic revenue further excludes certain acquisitions and divestitures for which there is less than a full period of comparable net sales.

Guidance excludes the previously announced agreement to acquire Penumbra, which is expected to close in 2026, subject to customary closing conditions. For more information, please refer to the Q1 financial and operating highlights deck, which may be found in the Investor Relations section of our website. On this call, all references to sales and revenue are organic, and relative growth is compared to the same quarter and prior year, unless otherwise specified. This call contains forward-looking statements regarding, among other things, our financial performance, business plans, and product performance and development. These statements are based on our current beliefs, using information available to us as of today's date, and are not intended to be guarantees of future events or performance. If our underlying assumptions turn out to be incorrect or certain risks or uncertainties materialize, actual results could vary materially from those projected by the forward-looking statements.

Factors that may cause such differences are discussed in our periodic reports and other filings with the SEC, including the Risk Factors section of our most recent annual report on Form 10-K. Boston Scientific disclaims any intention or obligation to update these forward-looking statements except as required by law. In addition, this call does not constitute an offer to sell or the solicitation of any offer to buy any securities or solicitation of any vote or approval in connection with the proposed transaction with Penumbra. Boston Scientific has filed with the SEC a registration statement on Form S-4, containing a proxy statement of Penumbra and a prospectus of Boston Scientific that contains important information about Penumbra, Boston Scientific, the proposed transactions, and related matters. At this point, I'll turn it over to Mike.

Thanks, Lauren, and thank you to everyone for joining us today. First quarter represented a solid quarter for Boston Scientific, with total company organic sales growth of 9.4% versus our guidance range of 8.5%-10%. First quarter adjusted EPS of $0.80 grew 6%, achieving the high end of our guidance range of $0.78-$0.80, and Q1 adjusted operating margin was 28%. Turning to our outlook, 2024 has proven to be a more challenging year than we initially expected. To that end, we are guiding to organic growth of 5%-7% for second quarter and reducing our full-year guidance to 6.5%-8%, reflecting unanticipated headwinds and changing business patterns that I will cover in more detail on this call.

Our second quarter 2026 adjusted EPS guide is $0.82-$0.84, and we now expect our full-year adjusted EPS to be $3.34-$3.41, representing growth of 9%-11%. I and our company does not take this change lightly. As I and Boston Scientific take great pride in ourselves in consistently executing against the guidance and goals we provide. Importantly, we remain convinced in the future of Boston Scientific. We have a strong global team committed to high performance, and we continue to invest in key new and existing markets, which we believe will enable us to deliver on our fundamental goal of driving differentiated performance over the LRP. I'll now provide some additional highlights on our first quarter, along with some comments on our outlook. Regionally and on an operational basis, the U.S. grew 11% with double-digit growth in five out of our eight business units.

Europe, Middle East, Africa grew 1% operationally. Growth in the quarter was driven by FARAPULSE, Coronary and Vascular therapies, and Neuromod, offset by the discontinuation of ACURATE and PolarX, largely impacting the EMEA region. Last year, we did announce our intent to discontinue the PolarX cryocatheter but have accelerated that timing given some recent safety events and the availability of non-thermal ablation technologies. As we look forward, we expect that growth in the EMEA will continue to improve with the annualization of the ACURATE discontinuation in 2Q and ongoing momentum from FARAPULSE, WATCHMAN, and other key products. Asia-Pac delivered a strong quarter and grew 12% operationally, led by double-digit growth in a number of countries, including Japan and China. First quarter growth in Japan was led by our differentiated PFA ecosystem with OPAL, FARAVIEW, and FARAPULSE, as well as strong reception of WATCHMAN FLX Pro.

Within the quarter, we're pleased to have received PMDA approval for the de novo indication of our coronary drug-coated balloon, AGENT DCB, expanding the patient population eligible for this differentiated technology. China also delivered strong growth inclusive of the impact from the VBP, led by our interventional cardiology portfolio, and particularly our imaging technologies. We are making consistent progress against our FARAPULSE goals in a competitive market in China and received NMPA approval within the quarter for OPAL HDx Mapping System with FARAVIEW, further building out the PFA platform. Now some commentary on our business units. I'll start with Urology. Urology did have a difficult quarter in Q1 as sales grew 1% organically, falling short of our expectations, driven primarily by the stone management and sacral neuromodulation businesses. Within stone, underperformance was driven by China VBP, as well as some key product gaps in the core stone portfolio.

We expect the recent FDA approval for Asurys to unlock value within our StoneSmart ecosystem alongside LithoVue Elite. We also anticipate launching additional new products in 2026, including a slim ureteroscope later this year. Our sacral neuromodulation business continued to see impact from commercial model disruption. Importantly, within the first quarter, we have hired and trained a significant number of new sales and clinical reps, and we do anticipate improvement in this pelvic health franchise throughout the year as the SNM commercial organization capability stabilize, along with the addition of eCoin tibial nerve stim with the closure of Valencia Technologies in April. We expect our urology performance to improve throughout the year. However, we now expect our full-year urology growth to be low- to mid-single digits in 2026.

Endoscopy sales grew 7% organically, with strong results across the business and better-than-anticipated performance from AXIOS, as we're able to ramp supply and available product sizes. As we look to the second quarter, we will continue to see some impact from AXIOS while also navigating other transient supply chain disruptions in Endoscopy. Importantly, we expect improvement in the second half of 2026 as the underlying business is very strong, and we anticipate resolution of the supply chain issues. Neuromodulation had a strong quarter with organic sales growing 15%, with our comprehensive portfolio growing low double digits, excluding the impact of Nalu. Our pain business grew mid-teens, inclusive of strong quarter from Nalu, as I mentioned, which closed at the end of January. Intracept continues to perform well, supported by compelling five-year data demonstrating the long-term efficacy and cost-effectiveness of this treatment for chronic low back pain.

In DBS, we saw continued adoption of the Cartesia X leads and accelerating uptake of the Illumina 3D programming algorithm in the U.S. Cardiovascular delivered organic sales growth of 11%. Within those businesses, we'll start with ICVT. Interventional Cardiology Vascular Therapies grew organic sales 8%. This business grew 9% organically, driven by double-digit growth in our coronary therapies franchise, with strength in AGENT and ongoing momentum with our imaging portfolio. Earlier this year, we completed enrollment in our FRACTURE trial, studying the size of the IVL device in coronary arteries, with data to be presented at EuroPCR on May 19th. We continue to expect launch in the U.S. in the first half of 2027.

Our Vascular Therapies business had a nice quarter, growing 7% organically, driven by double-digit growth in TCAR and Varithena, and this is offset by large VBP impact on their arterial business in China, which is expected to annualize in second quarter. We expanded our launch with our size of peripheral IVL for above the knee with positive physician feedback on performance. We expect to ramp our manufacturing supply chain over the course of the year and continue to anticipate launching our below-the-knee indication in the second half. In the first quarter, positive data from HI-PEITHO was presented at ACC evaluating EKOS plus anticoagulation versus anticoagulation alone, providing new clinical evidence that can help physicians make more informed treatment decisions for patients with acute pulmonary embolism. We remain excited about the opportunity to add Penumbra team and highly differentiated portfolio to Boston Scientific.

We anticipate that the deal will close in the second half of 2026, subject to the Penumbra shareholder vote on May 6th and the receipt of the remaining regulatory clearances. Our interventional oncology business had a nice quarter, with organic sales growing 15%, driven by our broad offering of cancer therapy technologies. Within the quarter, we received FDA clearance of Any Day Dosing and initiated a limited market release. Any day dosing is enabled by the TheraSphere 360 Y-90 management platform, allowing physicians to schedule treatments on more days of the week and offering more streamlined ordering and operational efficiencies. Cardiac rhythm management sales declined 3% in the quarter. Our low voltage business saw some impact in the quarter as we navigated our physician advisory and came up against a tough comp within our first quarter 2025 change outs.

On the high voltage side, we saw some impact from the Middle East conflict impacting this particular business. In the first quarter, our diagnostics franchise grew low double digits with continued strength across our broad diagnostic portfolio. Overall, we anticipate that our CRM business will return to growth in the second quarter and expect low single-digit growth of the year, supported by our full launch of the EluPro in the second quarter within the U.S. Turning to WATCHMAN. WATCHMAN grew 19% organically in the first quarter, which was below our expectations, with pressure on volumes in the U.S. as the quarter progressed. We believe this reflects the annualization of the initial concomitant adoption tailwind and a softening in standalone WATCHMAN cases driven by hospital capacity, related procedure prioritization, and evolving reimbursement dynamics.

Importantly, we remain focused on expanding physician and patient education within the approximately 5 million patient indicated population today. We expect data from CHAMPION-AF to support a return to 20% market growth over the LRP. In late March, CHAMPION-AF data was presented as a late breaker at ACC, with the trial achieving all primary and secondary endpoints, reinforcing the safety and efficacy of WATCHMAN and highlighting the high burden of clinically relevant bleeding on oral anticoagulation. As a next step, in addition to submitting for a label update, we are working with medical societies to support consideration of changes to LAAC guidelines using the totality of WATCHMAN clinical evidence ahead of any update to the national coverage determination. We also have additional data being presented at HRS this weekend, the CHAMPION-AF post-ablation analysis, which will provide further insights on this patient population.

Across the globe, the results from CHAMPION-AF provide important evidence to support the expansion of the patient population eligible for WATCHMAN over time in large markets including the U.S., Japan, China, and Europe. For full year 2026, we now expect global WATCHMAN growth to be mid-teens with low to mid-teens in the U.S. In the U.S., while concomitant demand continues to strengthen, we anticipate overall WATCHMAN growth to decelerate with tougher comps and expect standalone WATCHMAN procedures to improve over the course of the year as it takes time for the totality of this clinical evidence to translate into clinical practice. We remain very confident in the long-term outlook of the business, supported by great clinical evidence, market development, and new product innovation. Turning to EP, organic sales grew 22%, 18% in the U.S., and 30% internationally.

International growth was driven by our innovative portfolio, including our expanded OPAL mapping footprint and catheter utilization, with strong double-digit PFA growth in Europe in a highly competitive environment supported by the launch of FARAPOINT. U.S. growth was driven by continued expansion of the OPAL, strong catheter utilization, and FARAPOINT, our PFA focal point catheter, which is performing ahead of our expectations and has moved into full launch. Looking ahead, we now expect our global EP business to grow approximately 10% in 2026. Within the U.S., we are updating our full year expected growth to be in the mid-single digit range, with continued strength internationally at +20%, inclusive of full year impact of approximately $35 million from the discontinuation of PolarX.

This outlook is a change from previous commentary, but we feel it's prudent and reflects ongoing competitive dynamics offset by strength in our evolving FARAPULSE PFA catheter and mapping portfolio. We are highly confident in our ability to maintain our leadership position in PFA, both in the U.S. and internationally, through investment in commercial capabilities, ongoing clinical evidence, our expanding mapping footprint, and an impressive next generation catheter launch that's included in our FARAWAVE ULTRA in the first half of 2027. This weekend, AVANT GUARD study FARAPULSE in new patient population of drug-naive persistent AF patients will be presented as a late breaker at HRS. Additionally, we will see data from our first human ELEVATE-PF study studying FARAFLEX, which is our large focal map and ablate catheter for more complex arrhythmias.

We anticipate initiating our IDE later this year and continue to expect launching FARAFLEX in the U.S. in 2028. In closing, I'd like to share again my confidence in our team and the future of Boston Scientific. While this year has proven to be more challenging than we anticipated, we believe Boston Scientific is competing in the right markets with a WAMGR of approximately 8%, and we continue to be uniquely positioned to drive differentiated top-line growth. We will continue to do this through strategic internal innovation, clinical evidence, external VC, and M&A investments, along with our disciplined approach to expanding operating margins. All of which have resulted in our track record of delivering double-digit adjusted EPS growth. I'm very grateful to our talented team of global employees who work every day to advance science for life, and I'm confident in the sustainability of our top-tier financial performance.

With that, I'll hand it over to Jon.

Thanks, Mike. First quarter consolidated revenue of $5.203 billion represents 11.6% reported growth versus first quarter 2025 and includes a 220 basis point tailwind from foreign exchange, which was in line with our expectations. Excluding this $104 million foreign exchange tailwind, operational revenue growth was 9.4% in the quarter. Organic revenue growth was also 9.4%, in line with our first quarter guidance range of 8.5%-10%. Q1 2026 adjusted earnings per share of $0.80 grew 6% versus 2025, achieving the high end of our guidance range of $0.78-$0.80. Results include an approximate $0.01 headwind from FX. Adjusted gross margin for the first quarter was 70.5%, which represents a 100 basis point decline versus the first quarter of 2025, primarily driven by tariffs as well as inventory charges related to the discontinuation of our PolarX cryoablation system.

We now expect full year 2026 adjusted gross margin to be slightly below full year 2025, largely driven by lower than expected product mix benefit and incremental investments in our global supply chain and quality systems. First quarter adjusted operating margin was 28.0%. We continue to expect full year 2026 adjusted operating margin expansion of 50 basis points-75 basis points driven by OpEx leverage as we drive strong spend controls and continue to implement efficiency initiatives and optimize our organizational structure. On a GAAP basis, first quarter operating margin was 21.2%. Moving to below the line.

First quarter adjusted interest and other expenses totaled $112 million, in line with expectations, and our adjusted tax rate for the first quarter was 11.7%, which was in line with expectations and includes a benefit from stock compensation accounting. Fully diluted, weighted average shares outstanding ended at 1.495 billion shares in the first quarter, and free cash flow for the first quarter was $170 million, with $348 million from operating activities, less $177 million in net capital expenditures. We now expect full year 2026 free cash flow to be approximately $4 billion. As of March 31st, 2026, we had cash on hand of $1.453 billion and our gross debt leverage ratio was 1.8x. Our top capital allocation priority remains strategic tuck-in M&A, followed by share repurchase.

In alignment with this strategy, we recently closed the acquisition of Valencia Technologies, which complements our urology business, and we expect our announced acquisition of Penumbra to close in the second half of 2026. In addition, as previously disclosed, our board of directors recently approved an additional $4 billion under our existing share repurchase program, bringing our total authorization to $5 billion. While we have been restricted from being in the market, we intend to repurchase approximately $2 billion of our shares during the second quarter, subject to market conditions and applicable securities laws. I'll now walk through guidance for Q2 and full year 2026. We now expect full year 2026 reported revenue growth to be in a range of 7.0%-8.5% versus 2025, excluding an approximate 50 basis points tailwind from foreign exchange based on current rates.

We expect full year 2026 operational and organic growth to be in a range of 6.5%-8.0%. We expect second quarter 2026 reported revenue growth to be in a range of 5.5%-7.5% versus second quarter 2025, excluding an approximate 50 basis point tailwind from foreign exchange based on current rates. We expect second quarter 2026 operational and organic growth to be in a range of 5.0%-7.0%. We continue to expect full year 2026 adjusted below-the-line expense to be approximately $440 million. Under current legislation, including enacted laws and issued guidance, we now expect a full year 2026 adjusted tax rate of approximately 12.0%. We now expect full year 2026 adjusted earnings per share to be in a range of $3.34-$3.41, representing growth of 9%-11% versus 2025, including an approximate $0.04 headwind from foreign exchange.

We expect second quarter adjusted earnings per share to be in a range of $0.82-$0.84. In closing, we recognize that revising our guidance is a significant decision and not one that we made lightly. We believe our updated guidance appropriately reflects the unanticipated headwinds, and we remain highly focused on executing our full year 2026 guidance of 6.5%-8% organic revenue growth, 50 basis points-75 basis points of adjusted operating margin expansion, and 9%-11% adjusted earnings per share growth. For more information, please check our investor relations website for Q1 2026 financial and operational highlights, which outlines more details on first quarter results and 2026 guidance. With that, I'll turn it back to Lauren, who will moderate the Q&A.

Thanks, Jon. Bailey, let's open it up for questions for the next 35 minutes or so. In order for us to take as many questions as possible, please limit yourself to one question. Bailey, please go ahead.

We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. Again, please limit yourself to only one question. At this time, we will pause momentarily to assemble our roster. Our first question comes from Robbie Marcus with JPMorgan. Please go ahead.

Oh, great. Good morning, and thanks for taking the question. I wanted to ask whether Mike or Jon, two, three months ago, got on the fourth quarter call and provided the guidance, and I think a lot of people were expecting a lowering today based on some of the third-party data we've seen. It's not that surprising, but I guess the question is really what happened during first quarter that really prompted it? When did you realize it? What gives you the confidence, given there's going to be some deceleration throughout the year, that the LRP is still valid and that growth can improve in 2027 here? Thanks a lot.

Yeah. Thanks, Robbie. Good morning. I would say first quarter overall, we're pleased with that result. The 9.4% growth and on track for our margin and EPS. Essentially what we saw, there's really three main contributors to the takedown in that guidance, which is not my happiest moment and I am very disappointed in that, as we're a company that consistently delivers on our commitments. This is a guidance down that we quite frankly are not proud of, but we think it's the right thing to do and best reflects the current environment, and allows us to provide the proper prudent guidance.

We can talk about the future of the company in a minute. Talking about the takedown, and particularly, it's really focused on the three areas, primarily EP, WATCHMAN, and Urology. If you start with WATCHMAN, we saw very excellent growth, as you know, in 2025. We grew almost 30%. We saw really strong consistent volume trends in January. There was no signal to any WATCHMAN weakness until we really saw the early days of mid-February. We started to see declining WATCHMAN volume for the first time. As we did the analysis on that, we can talk more about it. Essentially, it is a strong increase in concomitant growth and a deceleration of standalone WATCHMAN. I'd rather go through all those details now. That's the first primary one. We see a declining WATCHMAN trend growth throughout first quarter.

Therefore, in our guide, we think it's prudent to assume that in that guidance range. We can talk more about the rationale and reasons for that. The second primary reason is EP. Our EP business had a very nice first quarter. We are absolutely confident that we will remain the PFA market leaders in the U.S. and globally in 2026. We have a very rich cadence, just an R&D review last week with the team, of launches the next two and a half years that's very impressive. That being the case, even though the market's strong, we did lose a bit more share than we anticipated. Again, and what we did is, in this guide, anticipated greater share erosion than we're particularly seeing. It still allows us to be the market share leader in PFA, where we're guiding globally to approximately 10% in EP.

The last reason making up is Urology, which I mentioned had a difficult first quarter. Neuromodulation had a real tough year a couple of years ago, and that business is growing double digits. I'm not saying Uro is going to return to double digits right away. Right now we're suffering in our core stone business and in the Sacral Nerve Modulation area. We have very active execution plans in place to fix Sacral Nerve Modulation, which we believe will be better as the quarters go on. Then core stone, we have some key product launches that will impact that business and help it quite a bit in 2027. It's essentially going to be a below-market year in Urology. Those are the three contributors overall to the guide down. That were all done very objectively.

We think it's prudent, and we think it's the best guide to provide, to give shareholders confidence and to set up the business the right way. As you look forward in the LRP, we're not going to make a comment on the LRP top-line growth at this point. We feel that will be under some slight pressure, clearly, given the 2026 guide. We will update that more in the future when we go through our strategic plan process. We are comfortable with the 150 basis points of margin improvement in LRP, and we're comfortable with delivering double-digit EPS growth through the LRP. I guess lastly, that the long answer I'm giving you is, we compete in an 8% WAMGR market. We almost always grow at or above this WAMGR.

This set up for 2026 would show us at market at the high end of our guide or below that WAMGR. This is not Boston Scientific. It's not what we do. In 2027, we have a number of key product launches. We'll have far easier comps than we do this year. We're very bullish about 2027 and 2028, and we can detail that more. Sorry for the long response. Hopefully, that helped a little bit.

Our next question will come from Joanne Wuensch with Citi. Please go ahead.

Thank you for taking the question. Mike, I think you just summarized what everybody needed to hear in that answer. Can you sort of walk us through a little bit, how you're thinking about the quarters over the next couple of quarters, particularly for EP, WATCHMAN, and Uro? I'm sort of trying to think about the gist of Robbie's question. How do we get from first quarter to fourth quarter and then the jumping off point into 2027? I just want to make sure those are somewhat set up appropriately. Thank you.

I'll take a shot, and Jon, you can clean up if I'm a mess here. We think second quarter is our toughest quarter of the year. We had a nice first quarter. Second quarter, we have very challenging dollar sequential quarterly growth comps on a dollar basis, particularly with EP and WATCHMAN. That's our toughest quarter there. We also think, with some of the impacts of some transient trends in endo and some other areas, that will be fixed for the second half of the year. We think second quarter is our toughest quarter. Thus the guide 5%-7%. The full-year guide, as you know, is 6.5%-8%. Jon, do you want to touch on any sequencing more?

Yeah. Thanks, Joanne. Maybe stepping through WATCHMAN and EP. You heard Mike mention in his prepared remarks, we expect global EP to grow mid-teens for the year. That would imply, Joanne, low double-digit growth for the rest of the year for our global WATCHMAN business. That's how you should think of WATCHMAN for the rest of the year. Global EP at 10% for the year implies mid to high single-digit growth for the rest of the year. If you then think of the rest of the business as mid-single digit growth, that's about where we landed in the first quarter. Expect to see some acceleration there within Urology, CRM to pick up. That's how you should expect the phasing as we go through the year. I'd say relatively consistent.

A slight uptick in the second half. They call it roughly 7% as we see Uro and CRM drive better growth as we move through the year.

Our next question comes from Larry Biegelsen with Wells Fargo. Please go ahead.

Good morning. Thanks for taking the question. I guess on EP, just maybe a little bit more color on the market and share assumptions, how they've changed. Where is this share pressure coming from, Mike? On USEP, sales have been flattish for the past three or four quarters. Should we expect relatively flat USEP sales for the rest of the year? What does that mean for 2027? I think people are trying to understand when you can get back to market growth in EP. Thank you.

Yeah, I think Jon just gave some of those numbers. For EP, for the year, we expect global to be approximately 10%. In the U.S. specifically, we expect mid-single digit growth, for the U.S. business, which implies a flat 2Q to 4Q. Flat to low single digit. In international, about 20%. Call it flat to low single digit U.S., mid-single digit for the year.

Okay.

That's the story there. What's different about it from our previous commentaries, where we said we would grow half market, we're disappointed to bring that guide level down, but we think it's appropriate. We aim to be, and we have high confidence that we'll maintain PFA leadership in the U.S., internationally, globally in 2026 and throughout this LRP. We are very excited about the product launches that we have, in particular, the three big ones coming up. In 2027, third generation FARAPULSE, a differentiated ICE platform, and we think a very disruptive FARAFLEX platform all in the next two and a half years. Today, we are seeing increased competition. There's three other large players in the marketplace. I believe we've made commentary before. Medtronic continues to be a solid competitor.

JJ is enhancing their footprint in PFA, and Abbott is early stages of launch in the U.S. In Europe, we're really proud of our European performance, where all three of those countries are performing, and we continue to grow at a 20%+ clip, where we quite frankly, have a quite advanced mapping capability and platform and doing very well there. We do expect a little bit more share erosion than we've anticipated in the past and previous guides, but we think this is the appropriate guide to do, and allows us to continue to have PFA market leadership while we're bringing that platform forward. Importantly, our mappers, which we've made a massive investment over the past two and a half years, continue to get stronger and stronger every quarter. We continue to install more and more OPAL mapping platforms.

Our mappers get more sophisticated, and we continue to add new catheters to the mix, along with FARAPOINT, which we recently launched. We'll continue to grow the mapping platform, continue to invest in that commercial capabilities. You'll see more direct investment in WATCHMAN, in particular, so we'll invest both commercially and marketing in both our WATCHMAN and our EP businesses. We're confident we'll maintain PFA leadership, but we are going to see a bit more share than we anticipated earlier in the year.

Our next question comes from Rick Wise with Stifel. Please go ahead.

Good morning, and thanks for taking the question. I was hoping you would, Mike, talk a little bit more about the Watchman outlook in more detail. I mean, CHAMPION-AF data obviously was excellent. Perhaps there was more controversy about the data and the reaction to the data than I expected and perhaps than you expected. How are you addressing some of the concerns that you were left with? How are you changing the narrative about the risks of Watchman? And maybe how specifically are you going to tackle the growth rate factors that impacted this quarter? Thank you very much.

Yeah. I'll ask Ken to add commentary here. First on some of the factors, and first of all, we're very proud that we essentially created this category, leading in clinical science, created the concomitant category. This category grew 30% last year, and we expected mid-teens growth this year. We're seeing evolving practice patterns as this product continues to evolve with great clinical data and changing practice patterns. With that extraordinary growth in AF ablations and WATCHMAN, we are seeing some practice pattern changes that I highlighted that we saw really become more acute in February. We're seeing terrific concomitant demand. Bottom line, we are seeing pressure in kind of the standalone WATCHMAN implant business, which historically has not been a challenge for us. Those challenges with the standalone WATCHMAN area are a bit multifactorial.

You're seeing a bit more switch to the EP from the interventional cardiologist, as the interventional cardiologist is less exposed to the concomitant procedure. They've got more structural heart procedures to do, and there's been a reimbursement cut in that area. You're seeing strengthening amongst the EP physician group. Those are some of the trends that have really moved it just recently, a bit more towards EP, a bit more towards concomitant, and less on standalone. Our customers are also adapting to operational workflow. They're adding new labs. They're moving to ASCs because they've experienced multi-year growth of, call it, 25% in WATCHMAN. Multi-year growth of 20%, 25% in ablations. There's a significant demand and pull, plus the approval of new structural heart procedures. The hospitals themselves are investing in labs. Particularly concomitant AFib are money winners for hospitals.

They're making the investments, but they're also moving through their own workflow challenges. We've seen a consistent backlog for WATCHMAN, which I guess is good. High demand, obviously, for AFib. On what are we doing to make it better, we're doing a lot right now to make it better. The most impactful thing quickly is commercial investments. We are putting more focused commercial investments directly at the WATCHMAN business. Today, we have a lot of strength because the same territory rep in many cases is serving both the EP customer, EP and WATCHMAN. We're going to augment them with additional focus on WATCHMAN specifically and put a little more emphasis and focus directly at that interventional cardiology call point.

We'll be making quite a bit of marketing investments to really highlight the outstanding data that we believe the first study of its kind that met its primary endpoints in CHAMPION-AF, that Ken can detail. Commercial investments, Medicare investments, marketing investments, physician activation investments, all to leverage CHAMPION-AF. It's also important to note, and then Ken can talk. I'm sorry. Too much coffee. Today, 25% of all WATCHMAN procedures are concomitant. We do expect that to grow to 50% over the LRP. That view hasn't changed. What we've seen is an offset a bit in standalone WATCHMAN procedures. Ken, you want to talk more about that?

Yeah, I don't have too much to add, Mike. Again, I think the first thing I'd say, Rick, in terms of the question, it just takes time to disseminate data and to educate physicians on the results of things like CHAMPION-AF. Of course, we were not able to get out and pre-promote ahead of the data release and ahead of the publication in the New England Journal of Medicine. Having said that, the trial hit all of its primary safety and efficacy endpoints and all of the important secondary endpoints. We do still anticipate that we will get updates to labeling, updates to guidelines, and eventually an updated national coverage determination. It just takes time for that to play through.

Then I think the other thing, just to reiterate what Mike said, in parallel with that, we see the opportunity to continue to improve some of the operational efficiencies that are required to unlock more operational capacity for handling these procedures. We see hospitals building out more labs dedicated to these procedures. The move of simple ablations to ASCs will further unlock capacity. Again, just to highlight what Mike said, we see a very large opportunity for continued growth in concomitant procedures. Maybe the one statistic I'd add to what Mike said, just to remind everyone, roughly 50% of ablations for AFib in the U.S. today are done in patients who are at high risk of stroke, who have a CHA2DS2-VASc score of three or higher, and who are potentially candidates for a concomitant procedure.

Our next question comes from David Roman with Goldman Sachs. Please go ahead.

Thank you. Good morning, everybody. I wanted maybe just to toggle over to the other 70%+ of the business that's non-EP and WATCHMAN, and appreciate some of the dynamics that you walked through on the call. Maybe you could unpack a little bit for us in more detail kind of where you see that cohort of the business going, some of the specific product launches that you expect to see in 2026 and 2027 that we should be watching, and the extent to which that piece of the business can get back toward kind of an 8% growth level where it was, call it, before the ACURATE discontinuation.

Sure. Thank you for the question, Dave. The area that's not getting the spotlight on it is this ICVT, Interventional Cardiology and Vascular Therapies group, which again, has that one-time rule with ACURATE, which will anniversary, thankfully, in May, which will help that business. That business is executing at a very high level, driving the double-digit growth in China despite VBP. Very global business. AGENT is continuing, and our imaging businesses in particular, continue to exceed our internal expectations, which is terrific. We're excited about the SEISMIQ launch that it's really been in the small scale thus far within our approval vascular business, and been very well received by physicians. That FRACTURE trial will read out at PCR in a month or so. We expect to have that coronary approval as we enter 2027.

We're focused right now on building up the manufacturing supply chain to enable a meaningful launch for SEISMIQ for both coronary and below the knee and above the knee applications in 2027. They also have a number of kind of singles, then doubles key product launches in vascular to continue to widen that portfolio out. The interventional oncology business grew mid-teens%, and I talked about a key workflow launch that they additionally had, along with some second M&A that they're executing on. Hopefully the shareholder vote goes positive for us with Penumbra on May 7th. We're really excited about that team, which is extremely talented and brings a really differentiated portfolio in gaps that we have across Boston Scientific in that category. Particularly in combination, standalone without Penumbra, that business is doing extremely well.

In the future, ideally with Penumbra, that's a very unique, powerful growth driver for the company over this LRP period. I think a lot of the discussion will still be on WATCHMAN, but much more will pivot to that area given the launches and momentum in that area. Lastly, I would just try to summarize MedSurg. Overall, similar to EP, we've had some challenges right now in urology. We're not happy with the 1% growth in the quarter. We have clear line of sight to how we're going to adjust and fix that, as that business will improve in 2026, but not at the level that we expect our business to perform at. We'd be highly disappointed if we weren't closer to market growth for that business in 2027. Endoscopy is doing well.

They've got a nice set of product launches coming over the next nine months. Our Neuromod business is growing double digit. Overall, MedSurg is a tick lighter in 2026 than we anticipate, and we'd say that business will improve as the quarters move on in 2026, and we'll have a stronger 2027.

Our next question comes from Travis Steed with Bank of America. Please go ahead.

Hey, everybody. On the WAMGR, I think there was a slight change to the WAMGR from 9% to 8%. Wanted to touch on that. On the LRP, was the message more, we're not achieving that 10%, or was it more, we'll kind of wait and see how it all plays out? Because in thinking about 2027, you sound pretty bullish on 2027. No headwinds, you have product launches. Just kind of curious how LRP-

On the WAMGR, Travis, I think we're pretty clear at the Investor Day that we were at 8% moving to 9% over the LRP. I believe that was the message on the WAMGR. We call it 8% moving towards 9%, because we're in the right high growth markets. I think that's consistent.

LRP.

LRP. Oh, the LRP, I mentioned it in the previous commentary. What we are confident in giving you now is we're confident in our ability to continue to have the discipline to improve margins of that 150 basis points. We're confident in our ability to execute double-digit EPS over this LRP period. On the sales side, obviously with a guide at 6.5%-8%, that puts pressure on the 10%+ guide we gave at LRP. I would say that's likely an upside scenario at this point, but it's premature for us to give you a LRP organic revenue growth number at this point. Let us work through our strategic plan and launch cadence, and we'll update that over the course of this year.

Great. Thank you.

Our next question comes from Josh Jennings with TD Cowen. Please go ahead.

Hi, good morning. Thanks for taking the questions. I just wanted to touch on the EPS guidance revision. I think some may be concerned that with the deceleration in high margin products, USEP franchise and WATCHMAN franchise, that there may be incremental pressure there. Any more details you can share just on any offsets or the impact on profitability with the revised outlook for USEP and WATCHMAN? Thanks for taking the question.

Yeah. Thanks, Josh. We will see less mixed benefit than what we expected at the start of the year. That's why we expect our gross margins now will be slightly lower than 2025. What we're doing is really driving leverage across OpEx. Most immediately, we put in much more restrictive spend controls across the company. What we're doing is we're reducing spend that isn't correlated to revenue generation or that isn't pointed at our key product pipeline programs that we have in place. We've also had, more broadly, a number of org structure optimization initiatives in place. That includes scaling our centralized shared services. We've got a number of AI, automation, other initiatives already in place, Josh, that drive cost efficiency and productivity. We're looking at those for what we can accelerate.

As it relates to the R&D portfolio, we're looking across each of the businesses there, ensuring that we're appropriately fueling and appropriately focusing on the most impactful programs. Those that are less impactful, we're looking at how we can trim those. We've got a number of initiatives, Josh, focused on how do we drive our OpEx toward the most impactful areas of the business and toward revenue generation, and then everything else we're squeezing.

Our next question comes from Marie Thibault with BTIG. Please go ahead.

Good morning. Thanks for taking the question. I wanted to double back to urology. I think you mentioned you have some active execution plans in place for improving the sacral neuromodulation business. Can you just dive a little deeper into that? I know that that's something you've been focused on for a couple quarters. Maybe it's going a little bit slower than hoped. If you can just give us an update on how that is going. Thank you.

Yeah, it's definitely gone slower than we anticipated. We just had too much commercial turnover, is the bottom line, taken over the course of the last six to nine months. We certainly learned from that. We made adjustments to it. At this point in time, we feel we have the right leadership structure in place, from region managers on up, that are so key to driving a business like this. We had quite a bit of turnover at the manager level, clinical rep level, and territory level. A lot of learnings from that as we look forward to Penumbra.

I would say on the management side, that's all been filled up on the region managers, which is important, and we've had nearly 100 people that have been hired and are at various stages of training, both clinical reps and territory reps, to really strengthen that commercial team, which is really needed, not only for case coverage, but also to drive the appropriate patient activation events and pull-through to appropriate procedures, which is really part of the business, and an area that Axonics did really well. We're also leveraging a lot of the internal capabilities from WATCHMAN on this. It's primarily been a commercial disruption issue that has lingered farther than we wanted it to.

At this point in time, we have made the appropriate hires, the appropriate training, the appropriate investment, and we are confident that we'll see an improvement in that business as the quarters progress.

Our next question comes from Vijay Kumar with Evercore. Please go ahead.

Hi, Mike. Thank you for taking my question. I had one question on this buyback. Generally, when we see companies announce large deals like Penumbra, a $15 billion deal, we generally see buybacks being suspended. My question is, the $2 billion buyback in 2Q, is that signaling anything on the deal? Jon, I think you mentioned you have $1.5 billion of cash on hand. How are you funding this $2 billion buyback? Are you going to raise any debt? Why now? Thank you.

Yeah. Thanks, Vijay. The $2 billion, we've got one half on the balance sheet now, and we project our cash over the second quarter. We'll fund that through cash on hand. We've been restricted from trading. We will be restricted at least through the Penumbra shareholder vote on May 6th. As soon as we're not restricted, we intend to repurchase $2 billion worth of shares, as I had mentioned. Why now is, we look at the stock price, we look forward at the outlook for the company that we have, our confidence in the company, the pipeline. We think that's a great use of our capital.

Our next question comes from Matthew O'Brien with Piper Sandler. Please go ahead.

Good morning. Thanks for taking my question. I was hoping to talk a little bit about Penumbra. I know the vote's coming up here in just a few weeks. Just curious about Boston's comfort level in adding additional cash to that transaction if required, just given the pullback in your stock and the degradation in the value of the overall transaction. If that were to be the case, would you still be committed to the deal at the previous valuation, if a higher cash component is required? Thanks.

Yeah, I would just comment on Penumbra in general. We've gotten to know their leadership team extremely well. We've really focused on the winning spirit of the momentum of the ICVT team we have, and the potential addition to Penumbra, we think is a very, very powerful business in combination over time. We've said many, many times that we essentially plan to run Penumbra as a business unit consistent in how we do Boston Scientific. Global presidents, keeping their strong commercial team intact, keeping the R&D pipeline. We have a very solid way to maintain and enhance the Penumbra momentum post-closing. We have the shareholder vote on May 7th. We're hopeful and confident that that will be approved as planned.

Our last question will come from Matt Taylor with Jefferies. Please go ahead.

Hi. Thank you for taking the question. I just wanted to follow up on some of the comments that you made about the outlook for WATCHMAN and PFA. Was hoping for more clarity on WATCHMAN in terms of how standalone was growing. You mentioned it was decelerating. Was it actually declining in Q1? And what's the outlook for standalone this year and next?

Yeah. We're not going to call out a specific number for outlook on concomitant, specific and standalone a little bit. I think we gave pretty good guidance as to what we see as appropriate guidance for the full year on WATCHMAN, which is global mid-teens%, U.S. low- to mid-single digits, international-

Low- to mid-teens.

I'm sorry?

Low to mid-teens.

Low to mid-teens. Sorry.

Yeah.

My bad. I was kind of thinking EP. Low- to mid-teens% for U.S. WATCHMAN, and international +20%. Mid-teens growth globally. That's our outlook, which is obviously a slower outlook than what we saw in first quarter, but it reflects what I mentioned earlier on overcoming some very, very strong comps, overcoming some efficiency issues that we see that I highlighted before, and more of a trend towards stronger and stronger concomitant and a less strong weakening trend in standalone. Now, over time, we aim to try and improve that based on the CHAMPION-AF results, the investments we're making. As I mentioned, you have concomitant strengthening, standalone currently less strong.

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