speaker
Drew
Conference Specialist/Operator

Good morning and welcome to the Boston Scientific fourth quarter 2025 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then 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 Tangler, Vice President, Investor Relations. Please go ahead.

speaker
Lauren Tangler
Vice President, Investor Relations

Thank you, Drew, and thanks to everyone for joining us. With me today are Mike Mahoney, Chairman and Chief Executive Officer, and John Monson, Executive Vice President and Chief Financial Officer. During the Q&A session, Mike and John will be joined by our Chief Medical Officer, Dr. Ken Stein. We issued a press release earlier this morning announcing our Q4 and full year 2025 results, which included reconciliations of the non-GAAP measures used in this release. The release as well as reconciliations of the non-GAAP measures used in today's call can be found on the investor relations section of our 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 are less than a full period of comparable net sales. Guidance excludes the previously announced agreement to acquire Valencia Technologies Corporation which is expected to close in the first half of 2026, and Penumbra, which is expected to close in 2026, each subject to customary closing conditions. For more information, please refer to the Q4 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 of the 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 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 factor 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 will file the SEC a registration statement on Form S-10-K Four, containing a proxy statement of Penumbra and a prospectus of Boston Scientific that will contain important information about Penumbra, Boston Scientific, the proposed transaction, and related matters. At this point, I'll turn it over to Mike.

speaker
Mike Mahoney
Chairman and Chief Executive Officer

Impressive, Lauren. Thank you. Good morning. Thanks, everyone, for joining us today. In 2025, we achieved over $20 billion in sales and for the second year in a row delivered mid-teens growth, surpassing our financial goals that we set at the beginning of the year. This outstanding and highly differentiated performance was fueled by innovation and execution across our business units and the winning spirit of our global team. In the fourth quarter of 25, total company operational sales grew 14%. Organic sales grew 13, achieving the high end of our guidance range of 11 to 13, with continuous strength across many of our businesses, including EP, Watchman, IO, Endo, and ICTX. Full year 25 operational sales grew 19%, while organic sales grew 16, exceeding our guidance of approximately 15.5. Q4 adjusted EPS of 80 cents grew 15%, exceeding the high end of our guidance range of 77 to 79 cents. Full year adjusted EPS of $3.06 grew 22%, also exceeding the high end of our guidance range of 302 to 304. On a full year basis, we expanded the adjusted operating margins by 100 basis points to 28%. Balancing dropped through on the strong revenue performance throughout the year with the reinvestment back into the business to drive long-term growth. Now for our 2026 outlook. We expect our differentiated financial performance to continue in our guiding to organic growth of 8.5% to 10% for Q1 and 10% to 11% for the full year. Our Q1 adjusted EPS guidance is $0.78 to $0.80, and our full-year adjusted EPS guidance is $3.43 to $3.49, representing a leveraged double-digit EPS growth of 12% to 14%. And John will provide more details. I'll now provide some highlights in Q4 and the 25 results, along with comments on 26 outlook. So regionally, on an operational basis, the U.S. grew 17% in the fourth quarter and 26% on a full-year basis. with exceptional performance across the business units, particularly EP, Watchmen, and ICTX. Operationally, Europe, Middle East, and Africa grew 5% in Q4 and 3% full-year. Excluding the impact of the accurate discontinuation, full-year EMEA growth would have been high single digits. EP also grew strong double digits in Q4 as we continue to lead with our ecosystem approach, offering differentiated technologies and comprehensive commercial support. As we look ahead to 2026, we anticipate momentum in EP and Watchman to continue in Europe and growth to be higher in the second half of the year once the impact of the accurate discontinuation is annualized. Now the Asia-Pac region. It grew 15% operationally in Q4 and 14% for the full year, led by mid-teens growth across Japan and China. Japan's growth in the quarter was driven by Watchman and EP, fueled by OPAL mapping system placements, and increased ferropulse cathode utilization, where we continue to gain share. China had another quarter of double-digit growth driven by EP, Watchman, and ICTX. We expect EP momentum to continue into 2026, supported by a recent NMPA approval of our Ferrowave Nav device, as well as indication expansion into the persistent AF population. Now some commentary on our business units. Fourth quarter urology sales grew 13% operationally and 3% organic on a full year basis. And the full year basis grew 23% operationally and 5% organically. Our performance in euro this year was below our expectations. And we expect that our overall business will return to market growth in 26 with supply chain issues behind us, new product launches, and the strengthening of our sacral nerve modulation franchise. We look forward to expanding our pelvic health with a recently announced acquisition of Valencia, which is expected to close in the first half of 26. Endoscopy delivered organic growth of 8% in both Q4 and for the full year and delivered a very strong year. Q4 growth was driven by our endoluminal surgery, imaging systems, and endobariatrics franchises, with the later receiving positive reimbursement support for ESG procedures. In December, we initiated a product removal for certain sides of our Axios device, due to a manufacturing variation. We do understand the issue and are working to bring these unique devices back to market in full by mid-year and anticipate lower endo growth in the first half of the year as a result. Neuromodulation had an excellent quarter, growing 10% in Q4 and delivering 8% organic growth for the full year. Our Brain franchise grew low double digits on a full year basis, led by the Cartesia X and Illumina 3D offerings, providing the full benefit of directional stimulation also improving efficiency and programming time. The pain franchise continues to strengthen and grew high single digits on a full year basis. This strong growth is a result of a deliberate strategy to expand our pain portfolio to bring options to the physicians, patients, and hospitals we serve. This is further strengthened by the close of the NALU acquisition, adding peripheral nerve stimulation, PNS, to our portfolio. And within the quarter, we received expanded reimbursement to coverage for the intracept procedure, initiated a full market launch of the Intracept Edge Stylet designed to improve the treatment experience. Our cardiovascular segment delivered 16% growth operationally in organic in fourth quarter and 22% operationally and 21% organic on a full year basis. In January, we announced agreement to acquire Penumbra, which is expected to close in 26. Penumbra offers a highly differentiated portfolio that operates in high growth segments where Boston Scientific lacks offerings, including mechanical thrombectomy and neurovascular. The deal is both strategically and financially attractive to Boston Scientific and delivers significant value to patients and customers globally. Within cardiovascular, interventional cardiology therapy sales grew 10% in Q4 and 8% on a full-year basis. We're very proud of the Coronary Therapies franchise, delivering double-digit growth in both the quarter and full year as we have shifted our underlying business to high-growth markets. Agent DCV has been a standout performer all year with its differentiated clinical benefit and reimbursement support, lifting our drug-eluting technology growth to over 20% on a full-year basis. We continue to make progress in other areas of the portfolio, and we're pleased to have completed an enrollment in the FRACTURE trial, studying our seismic IVL system. We anticipate presenting data from this trial later this year and continue to expect this differentiated technology in the first half of 2017. In Q4, we did reorganize the reporting structure of our peripheral interventionist divisions, and we've aligned the peripheral vascular business led by Kat Jennings with interventional cardiology therapies to amplify both commercial and R&D opportunities across similar technologies while retaining customer call point focus. This new business unit will now be called interventional cardiology and vascular therapies, Interventional oncology and embolization will continue to lead by Peter Patterson as a standalone business, and this structure will enable focus on this broad and unique portfolio. The peripheral vascular business grew 6% organically in Q4, with operational growth at 15%. Our two-year growth in Q4 was driven by double-digit performance in TCAR, supported by the recent launch of EnRoute in China. Within the quarter, we completed our first cases in the U.S. with a seismic IVL system. We're excited to add this differentiated and complementary technology to our portfolio and expect to expand our indication to include below the knee in the second half of the year. In Venus, low double-digit fourth quarter growth was driven by a continuous strength of Varathena and ECOS. We're pleased to have the high PIPO, our clinical study studying ECOS versus standard of care anticoagulants, accepted as a late breaker at ACC to be presented on Saturday, March 28th. Our interventional oncology and embolization business grew 17% operationally and 12% organically in Q4 and achieved nearly $1 billion in a full year, 25 sales, operational growth of 16, and organic of 12. Q4 organic growth is driven by our category-leading embolization and cancer therapies portfolio with ongoing strength in cryoablation, which treats a broad number of cancer types. And as we look ahead, we expect to continue to outpace the underlying market growth supported by new product offerings, such as TheraSphere 360 Y90 management platform, which is a web-based platform to simplify the entire process for patients and physicians. Cardiac rhythm management sales grew 1% organically in both the Q4 and for the full year 25. On a full year basis, our diagnostics franchise grew high single digits and now represents nearly 20% of our overall CRM business. In core CRM, our high-voltage business grew low single digits, and our low-voltage business was flat in the quarter. We continue to see demand for our conduction system pacing offerings, and at Q4, we began enrollment in the synchronicity trial, evaluating left fungal branch pacing compared to conventional cardiac resynchronization therapy. So as we look to 2026, we anticipate that our growth will be closer to market in CRM over the course of the year, driven by the addition of our complimentary bio-envelope and ongoing momentum within our diagnostics business. Our Watchman business delivered an outstanding 29% growth in Q4 and on a full-year basis, exiting the year with strong double-digit growth across all major global markets. We are extremely pleased with the performance of this franchise, with above-market growth driven by the strong adoption of concomitant procedures. We have now treated more than 25,000 patients concomitantly with Watchman. As we look ahead, we continue to invest in our portfolio, clinical evidence, and driving efficiencies for physicians. In the quarter, we announced a strategic partnership with Siemens Healthineers to develop and commercialize their next-generation 4D ice catheter called AccuNav, intended to offer physicians an innovative imaging option for standalone watchmen or Farrow watch procedures. And last month, we completed enrollment in the Simplify clinical trial, evaluating two single-drug regimens, as post-procedural alternatives to dual antiplatelet therapy, with data expected in the second half of 26. Importantly, our champion trial, a large randomized trial studying Watchman Flex versus novel oral anticoagulation was accepted and will be presented as a late breaker at ECC on Saturday, March 28th. If positive, this data would support Watchman as a first-line therapy for stroke prevention as an alternative to OAC and would expand the number of indicated patients from approximately 5 million today to $20 million globally. We're extremely proud of our global EP performance in the quarter, with organic growth of 35% in the fourth quarter, resulting in 73% growth on a full-year basis. As we enter our third year in the U.S. with our market-leading PFA technology, we believe that approximately 70% of AF ablations in the U.S. in 25 were done with PFA, with that number closer to 50% globally. Within the quarter, global growth is driven by PFA catheter utilization supported by OPAL placements and a scaled, high-performing commercial organization. We continue to invest in our ecosystem approach to innovation and recently received approval and limited market release in both Europe and the U.S. for our FairPoint PFA catheter. NAV enables that can create focal lesions initially indicated for atrial flutter. We're also studying FairPoint in the rematch AF trial for use in redo procedures. with data expected in 2027. We're pleased to have initiated the optimized trial studying the Cortex OptiMap mapping technology with the Ferripulse PFA system, which is intended to address our unmet needs in identifying sources of AFib as an alternative to traditional anatomic approaches, a capability that may be particularly important to more complex patients. As we look to 2026, we anticipate that the EP market will grow approximately 15%, and we expect to outpace that market growth led by our differentiated PFA portfolio, ongoing expansion utilization of mapping systems, and continued adoption of PFA across the globe. Importantly, Boston Scientific is uniquely positioned with its leading AF solutions portfolio and commercial team in the value to physicians and patients with our concomitant FairWatch procedure, supporting operational efficiency and capacity. So in closing, I'm extremely proud of our team and our performance in 2025, and we believe that our 26 guidance, along with our 26 to 28 goals of sales growing 10% plus, adjusted operating margin expansion of 150 basis points, and leveraged double-digit EPS growth continue to be highly differentiated. We have an incredibly strong global team that's focused on advancing science for patients globally while delivering differentiated results today, setting us up for a strong 2026 and beyond. With that, I'll turn it over to John.

speaker
John Monson
Executive Vice President and Chief Financial Officer

Thanks, Mike. Fourth quarter consolidated revenue of $5,286,000,000 represents 15.9% reported growth versus fourth quarter 2024. It includes a 160 basis point tailwind from foreign exchange, which was in line with our expectations. Excluding this $74 million foreign exchange tailwind, operational revenue growth was 14.3% in the quarter. Closed acquisitions contributed 160 basis points to sales, resulting in 12.7% organic revenue growth at the high end of our fourth quarter guidance range of 11% to 13%. Q4 2025 adjusted earnings per share of 80 cents grew 15% versus 2024, exceeding the high end of our guidance range of 77 cents to 79 cents. Outperformance was driven primarily by our favorable adjusted tax rate in the quarter. Full year 2025 consolidated revenue of $20.74 billion represents 19.9% reported growth versus full year 2024 and includes a 70 basis point tailwind from foreign exchange. Excluding this $114 million tailwind from foreign exchange, operational revenue growth for the year was 19.2%. Closed acquisitions contributed 340 basis points to sales, resulting in 15.8% organic revenue growth, exceeding our full year guidance of approximately 15.5%. Full year 2025 adjusted earnings per share of $3.06 grew 22% versus 2024, exceeding the high end of our guidance range of $3.02 to $3.04, and marking our third consecutive year of 20% plus adjusted earnings per share growth. Adjusted gross margin for the fourth quarter was 70.7%, resulting in full year 2025 adjusted gross margin of 70.6%, representing a 30 basis point expansion versus full year 2024. In 2026, we anticipate full year adjusted gross margin to be roughly in line with full year 2025, as we expect favorable product mix to be largely offset by investments in our global supply chain and the annualization of tariffs. Fourth quarter adjusted operating margin was 27.3%, resulting in a full year 2025 adjusted operating margin of 28.0%, improving 100 basis points versus full year 2024. In 2026, we expect to expand adjusted operating margin by 50 to 75 basis points, progressing toward our goal of 150 basis points of operating margin expansion over our long-range plan. On a GAAP basis, fourth quarter operating margin was 15.6%, resulting in a full year reported operating margin of 18.0%. These results include a $194 million litigation charge relating to the full resolution of a legacy IP related matter. Moving to below the line, fourth quarter adjusted interest and other expenses totaled $99 million, resulting in full year adjusted interest and other expenses of $430 million, slightly favorable to our expectations, primarily driven by higher interest income. On an adjusted basis, our tax rate for the fourth quarter was 10.7% and 11.7% for the full year, which was favorable to expectations and inclusive of favorable discrete tax items. Our operational tax rate was 14.9% for the fourth quarter and 14.2% for the full year, in line with our expectations. Fully diluted weighted average shares outstanding ended at 1,496,000,000 shares in the fourth quarter and 1,494,000,000 shares for full year 2025. Free cash flow for the fourth quarter was $1,013,000,000 with $1,364,000,000 from operating activities less $351,000,000 in net capital expenditures. Full year 2025 free cash flow of $3,000,000,000 $659 million exceeded our expectations, reflecting 38% growth versus 2024 and 80% free cash flow conversion. For 2026, we expect full year free cash flow to be approximately $4.2 billion, and we continue to target free cash flow conversion in the range of 70% to 80% over the long-range plan. As of December 31st, 2025, We had cash on hand of $1,965,000,000, and our gross debt leverage ratio was 1.9 times. Following the announcement of our agreement to acquire Penumbra, all three major rating agencies affirmed our single A minus equivalent credit rating. Additionally, fixed ratings upgraded our outlook from stable to positive. Our capital allocation priority remains strategic tuck in M&A, followed by share repurchases, In alignment with this strategy, we recently closed the acquisition of Nalu Medical, which is complementary to our nerve modulation pain franchise. Additionally, we announced agreements to acquire Valencia Technologies and Penumbra, which, upon close, will enable Boston Scientific to enter strategic adjacencies within our urology and cardiovascular businesses, respectively. Our legal reserve was $242 million as of December 31st. with $46 million already funded through our qualified settlement funds. I'll now walk through guidance for Q1 and full year 2026. We expect first quarter 2026 reported revenue growth to be in a range of 10.5% to 12% versus first quarter 2025, excluding an approximate 200 basis point tailwind from foreign exchange based on current rates We expect first quarter 2026 operational and organic revenue growth to be in a range of 8.5% to 10%, which includes an approximate 150 basis point impact from the discontinuation of accurate and a transient impact associated with the product removal of certain sizes of our Axios device. We expect full year 2026 reported revenue growth to be in a range of 10.5% to 11.5% versus 2025, Excluding an approximate 50 basis point tailwind from foreign exchange based on current rates, we expect full year 2026 operational and organic growth to be in a range of 10% to 11%. We expect full year 2026 adjusted below the line expense to be approximately $440 million. Under current legislation, including enacted laws and issued guidance, we forecast a full year 2026 adjusted tax rate of approximately 12.5%. In Q1, we anticipate our adjusted tax rate will be approximately 12%. We expect full year 2026 adjusted earnings per share to be in a range of $3.43 to $3.49, representing growth of 12% to 14% versus 2025, including an approximate 3 cent headwind from foreign exchange. We expect first quarter adjusted earnings per share to be in a range of 78 cents 80 cents in closing i'm pleased with the strong financial performance our global team delivered in 2025 and we look forward to executing on our full year 2026 guidance of 10 to 11 organic revenue growth 50 to 75 basis points of adjusted operating margin expansion and 12 to 14 percent adjusted earnings per share growth For more information, please check our investor relations website for fourth quarter 2025 financial and operational highlights, which outlines more details on fourth quarter results and our 2026 guidance. And with that, Lauren, I'll turn it back to you to moderate the Q&A.

speaker
Lauren Tangler
Vice President, Investor Relations

Thanks, John. Drew, 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. Drew, please go ahead.

speaker
Drew
Conference Specialist/Operator

We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're 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 2. Again, please limit yourself to only one question. At this time, we will pause momentarily to assemble our roster. The first question comes from Robbie Marcus with JP Morgan. Please go ahead.

speaker
spk12

Oh, great. Thanks for taking the question. I'll ask the question that's on everybody's mind today. Mike, there were fears that USEP and US Watchmen could come in soft, and USEP was flat with third quarter. US Watchmen missed by a hair. What exactly happened in the quarter versus your expectations versus the market? And the reason people are concerned is these are two of the key growth drivers. So you talked about confidence in above 15% EP growth next year of the market, the street sitting at around 25%. It feels like that needs to come down. Hopefully you could help us level set expectations for those two key products, what happened in the quarter and how to think about them in 26. Thanks.

speaker
Mike Mahoney
Chairman and Chief Executive Officer

Well, thank you. Thank you, Robbie. Happy to. And I'll touch on your question. Overall, we're super pleased with a quarter in the full year, growing 16%, EPS growing 22% for the full year, and six of our eight business users growing faster than market, growing faster than the WAMGR, and setting us up for a strong guide and investments for the overall company. The two businesses that you called out, I think you nailed it. If you look at EPS, We're quite pleased. Actually, our results in Q4 exceeded our internal target, and Watchman grew 29%, pretty much similar to the third quarter, as we lapped the anniversary of the concomitant reimbursement a year ago. Specific to EP, really pleased with the results at 35%. Two of our larger competitors had results of 6.5% growth, the market leader. Third place player, 12.5%. We grew 35. So we continue to gain share overall. And to your point, we think the market in Q4 was closer to 18 to 20% growth rather than what some other companies that claim to 25%. So we think the market was kind of 18 to 20% range, similar to what we developed internally in our plan. And we've called the market for 2026 about 15% growth. So we think it's an excellent market. We don't think it grew 25% in fourth quarter. We grew faster than our peer group based on this percentage that I saw or that we laid out. We actually grew even faster outside the U.S. than the U.S. The U.S. is more highly penetrated with PFA. There's actually more competitors present outside the U.S., and we've accelerated growth outside the U.S. So our PFA performance is quite strong. The market's still healthy. We think it's 18% to 20% in fourth quarter. And we exceeded our internal plan, and we got new products approved. Our mapping footprint continues to grow. And we have a lot of clinical data that various clinical studies that are in flight. So we're very confident with our PFA business and our performance. With Watchman, we grew 29%. Excellent job. We pretty much are the market with Watchman. Concomitant continues to grow. And we did annualize the concomitant reimbursement, which happened fourth quarter last year. So we're quite proud of the 29%. You know, when you come to these consensus numbers, We exceeded our guidance. We actually exceeded analyst consensus. The mix of that is slightly different, but it shows the power of all of Boston Scientific being able to deliver, to beat our guidance, to beat consensus in the quarter and the full year. And we're quite proud of the EP performance based on the commentary I just provided.

speaker
Drew
Conference Specialist/Operator

The next question comes from Larry Beagleson with Wells Fargo. Please go ahead.

speaker
Larry Beagleson

Good morning. Thanks for taking the question. Look, I'm sure there'll be a lot of questions on the USEP business, but I wanted to ask about Watchman. So basically, my question is, can you confirm, you know, you're not seeing an impact from the three, you know, recent trials we saw, you know, in 2025? And I want to ask about Champions. It's such an important trial. You know, maybe for Dr. Stein, what endpoints do you think physicians will be most focused on and How important do you think it is to physicians to see similar rates of both ischemic and hemorrhagic stroke like we did in option? And I'll leave it at that. Thank you.

speaker
Dr. Ken Stein
Chief Medical Officer

Yeah, well, again, look forward to presenting the results of Champion at ACC. We will be hosting an event for investors on that Saturday night at 5.30 p.m. Central Time and You know, we can get deep into the data at that point. Again, I think, you know, there are two co-primary endpoints, you know, one non-inferiority for combined endpoint stroke, systemic embolism, and death, one for bleeding. And just as we saw with option, I think both of those are going to be important for the field. In terms of the first half of your question, it can absolutely, again, you just saw the numbers we reported out. can very, without any equivocation, say that we have not seen any impact from those trials, closure, alone AF and ocean. And again, we continue to see very robust uptake of Watchman in general and of concomitant procedures specifically.

speaker
Drew
Conference Specialist/Operator

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

speaker
Travis Steed

Hey, thanks for taking the question. I guess I want to push a little more on USEP just because it was flat sequentially and your RF competitors grew 18 million and 26 million sequentially in the US. So it doesn't like share change versus last quarter, at least on a sequential basis. And I don't know if there was something that changed late in the quarter because you were pretty bullish at some December meetings with investors. And so I don't know if anything kind of changed at the end of the quarter and especially considering the Q1 guide of 8.5% to 10% and kind of what that means for EP in the early part of 26?

speaker
Mike Mahoney
Chairman and Chief Executive Officer

I think we've been pretty consistent with our messaging on EP. We do think the market's 18 to 20, like we said. I think some maybe have overshot the market growth in Q4. When you're the highest market share leader in PFA and competitors are coming out, we planned and we did expect to lose some share. given the competitive launches that are coming out and giving our really dominant market share position going into 2025. So we did anticipate that. And we are also very comfortable to say, as we looked at the end of 26, that we'll be the clear BFA market leader. And we also think our EP business will grow faster than 15%. So with new interest coming, it's not surprising that we lost some share. But the overall EP growth of 35%, I think, is quite impressive given the size of that business now and grew faster overall than our competitors. On the first quarter guide, we guided full year to 10 to 11, which we think is strong guidance given where we are early in the year here. And 8.5% to 10%, it's simply two factors, really. One is our toughest comp of the year. And secondly, we do have about 150 bps of impact from the Acura discontinuation along with the Axios withdrawal. Well, not full withdrawal, but partial matrix withdrawal, which will impact the first half of the year. So we see both those products, both those issues will be addressed as you get into, call it June, for the second half of the year with the impact of Acura being gone, Axios being gone, our product launches, and slightly easier comps, although it's still tough, but slightly easier in the first quarter.

speaker
Drew
Conference Specialist/Operator

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

speaker
Rick Wise

Good morning, Mike. I hate to stick with EP, but looking at the EP discussion from another angle, maybe talk us through your expectations for how the 25-year is going to unfold, maybe the cadence of the year. specifically relating to better understanding the growth acceleration that seems likely to occur as the quarters progress, helped by your innovation pipeline. And so maybe you can drill down further into what are the implications of Fairpoint and talk to us again about the ancillary products like ice, catheter, etc., and maybe any updates on the Ferroflex timing. So we better understand how, again, the cadence of 25 and the setup as we head into, I'm sorry, for 26 and the setup for 27. Thank you.

speaker
Mike Mahoney
Chairman and Chief Executive Officer

Sure. I guess, you know, as we exit 25, you know, we're kind of in a, what, a 65% PFA market share position. We have a market that we think is going to grow 15%. We have high utilization in the U.S., call it 80%, 70, 80%, and outside the U.S., quite a bit lower. So with a healthy market, we expect to continue to grow above market. Our PFA share will reduce somewhat, but we're very confident by year end, likely if you add all the other competitors together, our share will be equal to them or higher. in that area. We're not going to break out share by quarter, but we're very confident that we'll maintain clear market leadership in PFA over the course of 2026 and beyond. And I think if you look at the drivers that continue the strong pace of growth overall, one, it's geographic scope. We continue to gain share in Japan. We just got a persistent indication. We continue to drive more account openings, utilization in Japan. China is a very, very big market, a small part of our number. We made significant investments the past 18 months in China. And you'll see China have a more significant impact on our overall global growth. Europe's the most competitive market, but our growth rate's quite impressive there. And we just got approval for the Fairpoint catheter. In the U.S., same thing. Our now more significant mapping, scaled mapping commercial team continues to gain experience. continues to add more mappers, more opal systems. The FairPoint product will allow us more time in the lab to expand our reach in different clinical indications. And we have a host of products in the pipeline. You mentioned a few of them. They won't impact 2026 in a meaningful way, but we will continue to widen out the portfolio with our Cortex clinical trial work being done, the recent FairPoint approval. And then we have a whole cadence of new catheters coming. over the coming one to three years. So we have significant investments in the portfolio, and we continue to expect to be the clear market leader and have a very strong 26 growing fast for the market.

speaker
Drew
Conference Specialist/Operator

The next question comes from Joanne Winch with Citibank. Please go ahead.

speaker
Joanne Winch

Good morning, and thank you for taking the question. I suspect many of us will be picking through Watchman Ferra Pulse or EP for quite some time. But to drive the back half of the year, I suspect other products are accelerating. And it's not just easing comps from Axios and Accurate. What would you like to highlight to us that you see for a second half accelerant and then into 2027 so maybe we can expand our focus just a little bit? Thanks.

speaker
Mike Mahoney
Chairman and Chief Executive Officer

Yeah, great. I think, again, we expect to have a great year in EP and Watchman. We've got Champion Trial coming out. Those results will be coming through. Concomitant is doing terrific. We're training more EP docs on concomitant every day. As you said, broadly, the comps do get a little bit easier. We expect to have stronger performance in a number of our business units in 26 versus what we had in 25. We do expect our PI business our Euro business, our Neuromod business, and our CRM businesses to have stronger years in 26 than they did in 25. Not many questions on Neuromod, but that business is expected to be a high performer in 26, along with improvement in PI, Euro, and CRM. And then you have our other businesses, which are performing quite well. As we get through this Axios issue, our Endo business is strong. Our IO business has now scaled to over a billion dollars, growing nicely in the double digits. Our coronary business grew 20% in the quarter, and now we're launching our seismic IVL and PI, and we just had finished enrollment in our IVL platform for coronary. And importantly, you know, we've also initiated our first clinical work with Vitalist and hypertension. So we have a number of investments that we're making for the long term, and it's really the whole of Vasa Scientific, And of our eight divisions, six of them grew faster than market, which is pretty consistent. We grow faster than WAMGR. So we love our EP business. We love our Watchman business. But it's the entire company that gives us confidence in the 10% to 11% guide for the full year.

speaker
Drew
Conference Specialist/Operator

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

speaker
David Roman

Thank you. Good morning, everyone. I wanted to ask, Mike, if you could just expand on a little bit more as you think about the diversification of growth drivers here on a go-forward basis. As you kind of reflect on 2025, you had some challenges in urology. You're raising some challenges here in endoscopy in the first half of the year. So what investments and processes are you putting in place to make sure that you're seeing consistency and performance in the non-EP and watch and businesses, given those will represent a much more significant percentage of growth here on a go-forward basis.

speaker
Mike Mahoney
Chairman and Chief Executive Officer

Yeah, we do that every day at the company. I highlighted on Neuromod, a smaller business, but I think you'll see strong performance in 2026. We just added additional product in that category via acquisition. Neurology was a tougher year this year. We had some supply chain issues. Axonics integration didn't go as well as we wanted to initially with some commercial disruption. but we feel comfortable with that. So also with new product launches coming to urology, we expect urology to be at minimum back-to-market growth with our euro business, Neuromod quite a bit above growth. And Endo is really a solid, high-performing company with second-half launches that'll be important for us once we get through that Axios issue. So a lot of confidence that MedSurge in general should have. Ideally, we plan on a better year than 26 and 26 versus 25. And other businesses, you know, ICTX is a very large business with us now. Our complex coronary business grew 23%. I'm sorry. Complex coronary grew 31% in the quarter, 23% for the year. And our ICTX business, despite the discontinuation of Accurate, grew 10% in the quarter. So that business is doing extremely well with agent, with our imaging portfolio. And we have the most product launches and biggest clinical studies in that business. So we continue to diversify and strengthen that ICTX business that's doing quite well, our interventional oncology business. We have new product launches there. We've done a tuck in M&A. So we continue to fuel all of our businesses. We don't invest at the same rate for all of them, given the Watchman and EP growth profile. But it's classic Boston Scientific doing organic R&D, tuck in M&A, to continue to grow above our weighted average market growth rate.

speaker
Drew
Conference Specialist/Operator

The next question comes from Patrick Wood with Morgan Stanley. Please go ahead.

speaker
spk14

Beautiful. Thank you for taking the question. I'd love to hop off essentially from that topic. If I zoom out, there's been a ton of money spent building out people's vascular sales forces, obviously the proposed transaction on your side, but some of your peers too in the last kind of 18 months. And I guess as I was reflecting on that, I was like, how much is that going to help things like Seismic and the IVL side and TCAR building up that force in a larger way? And then equally, are there things coming down the pipe, you know, over and above agent that we can't see on the vascular side that's causing a lot of money to be deployed in acquiring and building out sales forces there?

speaker
WAMGR

Thanks. Thanks. I'm not sure I quite get the question.

speaker
Mike Mahoney
Chairman and Chief Executive Officer

I would say on the commercial side, we have tremendous scale in our EI business commercially and within our interventional cardiology business. We're combining the reporting structure of those business units together. So we're very much market leaders in that area. The announcement of Penumbra, as we talked about, is really exciting for us. It gets us into new high growth markets. in PE and neurovascular, just to name a few, with a highly scaled sales force. So in terms of commercial clinical capability, I think we're pretty unmatched in that area. And traditionally with a company, you've seen a lot of organic R&D, like Agent was, and a lot of clinical work with new products being introduced, starting with IVL this year. And we'll continue to look at more Tuck and M&A there. So I think That whole, we call that ICTV, ICVT area now, we're very bullish on, and some of the biggest investments in the company are in that area.

speaker
Drew
Conference Specialist/Operator

The next question comes from Danielle Antalfi with UBS. Please go ahead.

speaker
spk17

Good morning, guys. Thanks so much for taking the question. And Mike, sorry, this is another EP Watchman question. And maybe it's actually for Dr. Stein, though. I mean, I guess I'm curious, as you see competitors launch, I know you guys talked about like pretty significant efficiency gains with, uh, Sarah pulse and PFA devices overall. Those are probably slowing. You know, we have Watchman coming. I mean, I asked this at the analyst day, but I'm just curious what's playing out in the real world as far as capacity at the EP lab, because a lot of the docs we talked to sound like they have growing wait lists for their EP procedures. And this could only just get exacerbated once champion comes assuming champion's positive. So I'm just curious what you could say to that and how much that is currently impacting overall market growth. Thanks so much.

speaker
Dr. Ken Stein
Chief Medical Officer

Yeah, Danielle, I think you nailed it, right? I mean, we've now anniversary, I mean, we're three years into the launch of Farrah Pulse in the US. I think the efficiency gains that people saw, you know, are largely now built into the system. And, you know, I think as Mike said, you know, that's why what we're looking for, again, is 15% growth in the EP market next year. Again, we are growing and believe we will continue to grow faster than that market. But, you know, the keys, again, I feel a little sort of almost silly that I'm apologizing for 15% growth and, you know, what's one of the largest markets in med tech. But, you know, the keys to driving that forward will be, A, starting to build out of ASCs in the United States to unlock some more capacity and reduce those waiting lists. Continue just development and repurposing cath labs for the use for EP procedures. in the hospital, continuing what we can do as a company to help further drive greater efficiency in procedures. So things that we can do with concomitant procedures, just growth of concomitant overall helps with that efficiency. We've talked about some of the other investments that we've made, the partnership with Siemens for de-ice. But really, until all of those things play out, You know, that's why we really don't see growth exceeding 20% in the market and why that 15% seems to us to be a much more realistic way to view it. But again, to close, but it is our intent to continue to grow faster than that market.

speaker
Drew
Conference Specialist/Operator

The next question comes from Michael Polark with Wolf Research. Please go ahead.

speaker
Michael Polark

Hey, good morning. I have a question on ice. So the partnership with Siemens Healthineers for the 4D catheter versus your plans to launch a 2D product, can you just help us understand, do these things work together? Does the partnership with Siemens, you know, is that a reflection of a fresh view on how you plan to go to market with the 2D product? Help us understand how these are catalysts, how they coexist. I would appreciate any call. Thank you.

speaker
Mike Mahoney
Chairman and Chief Executive Officer

Yeah, we'll give it a little bit. It's a bit too early for that. We're excited about the Siemens collaboration. That's a product that's in development. It's not commercially available yet. So we, in partnership with them, it's really going to be different segments. That'll be very much a premium product and markets that can pay for premium product. And we think it'll be differentiated and, you know, further differentiate, you know, our Watchmen and Fairflex capability. 2D ice would be a different price point. It's been an established market for a while. So our 2D ice programs will really be just a nice portfolio addition to our overall portfolio within our EP portfolio bag.

speaker
Drew
Conference Specialist/Operator

The next question comes from Matt Taylor with Jefferies. Please go ahead.

speaker
Matt Taylor

Hi, thanks for taking the question. I wanted to follow up on Campion. You sound excited about that and should be. It's a big study. I was wondering if you could comment on the range of outcomes for that, obviously non-inferiority trial. Do you think there's any chance of showing superiority on any of the endpoints or the secondary endpoints? And I also wanted to ask if you think a positive Campion result could boost concomitant in the option indication. Yeah, Matt.

speaker
Dr. Ken Stein
Chief Medical Officer

First of all, just to clarify, the bleeding endpoint is powered as a superiority endpoint. We'll see what it shows when we report it out, but the goal there would be to show superiority on bleeding complications. I think you would have needed to power for superiority on stroke would have needed a trial that would probably have been an order of magnitude larger. And so that's part of, and I, well, let me just backtrack on that a little bit. And I don't think we need to show superiority on stroke. Again, the goal here would be to show that Watchman would be non-inferior, so as effective as the drugs, but to be able to show superiority on bleeding. And again, that was what we demonstrated with option. And I think everyone's seen the impact that that's had for the option population. In terms of the second part of the question, you know, I think it's a perceptive question because, you know, there are a couple of things that would happen if Champion does turn out to be positive. All right. And one is developing the new indication, but the other is strengthening the current indication. And so I do believe that a positive champion would give increased impetus for referrers to referring for the current indication, which includes the option indication. It will take time to build out the new indication, get better representation and guidelines, and get a revision of the CMS national coverage decision. And again, that's part of, you know, when we look at the champion story, right, if it's positive, it's not just a step change in growth in Watchman, but something that sustains the growth in Watchman over our long-range plan.

speaker
Drew
Conference Specialist/Operator

The next question comes from Josh Jennings with TD Cowan. Please go ahead.

speaker
Josh Jennings

Hi, good morning. Thanks for taking the question. Mike, it's only been a couple months since the investor day, and I think I just wanted to hear about your confidence level in hitting your LRP targets through 28, specifically the 10% plus organic revenue growth goal. Throughout this call, I think your confidence level is clear that 2026 guidance is achievable, but any updates just on your confidence level through the LRP and the double-digit organic revenue growth target? Thanks for taking the question.

speaker
Mike Mahoney
Chairman and Chief Executive Officer

Yeah, it hasn't changed. If we were doing our investor day today, we'd get the same numbers. 10% plus, 26 to 28, 150 bps of margin improvement, strong double GDPS growth, even within that. And then we think Penumbra further enhances our WAMGR and further strengthens the company beyond that. So really, no change of position here. Our whole key to our business is being in fast-growth markets, which we've demonstrated. We anticipate in that time horizon that Lambert gets closer to nine. Penumbra actually could slightly even improve that once that closes by a small margin, but slightly improve it. And excluding Penumbra, we're very comfortable with those LRP goals, as we stated.

speaker
WAMGR

And I understand there's time for one last question.

speaker
Drew
Conference Specialist/Operator

I have that from Chris Pasquale with Nephron Research. Please go ahead.

speaker
Chris Pasquale

Great. Thanks for fitting me in. I think I heard you say that you think U.S. PFA penetration is already at 70% for AF cases, which is a little higher than we were thinking, and suggest that we're already in the latter innings of that mix shift. I'd love to hear your thoughts on what's left to penetrate with PFA penetration. particularly as we think about other procedure categories like SVT or VT, and what's going to be necessary from either a product or a data perspective in order to really move into those segments?

speaker
Dr. Ken Stein
Chief Medical Officer

Yeah, thanks, Chris. Again, I think, first of all, right, 70% penetrate in AFib. There's still 30% left to penetrate. And, you know, there's always just a tailwind of adoption of new technologies. I think as you look at arrhythmias other than atrial fibrillation, there is probably the two prime use cases where we would see a real advantage to moving to PFA would be for atrial tachycardias, the atypical atrial flutter type thing. Although, frankly, we think that's going to be a diminishing part of the market going forward. Because usually where that's seen, that's a redo AF ablation. And we just see redo numbers shrinking with the efficacy of Farapulse for de novo ablation. I think the other thing you hit on is ventricular tachycardia. We are already engaged in a couple of studies of using Farapulse technology for ablation in the ventricles. And it's one of the areas where both the FaraPoint catheter and FaraFlex catheter, which is in development now, and very pleased with the progress of that in its first human use studies. But that is one of the areas where, again, I think those catheters and those form factors are going to shine.

speaker
Lauren Tangler
Vice President, Investor Relations

Thank you for joining us today. We appreciate your interest in Boston Scientific. If we were unable to get to your question or if you have any follow-ups, please don't hesitate to reach out to the Investor Relations team. Before you disconnect, Drew will give you all of the pertinent details for the replay.

speaker
Drew
Conference Specialist/Operator

Thank you, everyone. using replay code 9663601 until February 11th, 2026 at 1159 p.m. Eastern Time. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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