Earnings Call Transcript - BSX Q4 2025

Operator, Operator

Good morning, and welcome to the Boston Scientific Fourth Quarter 2025 Earnings Call. 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.

Lauren Tengler, 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 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 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 at 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 will file the SEC a registration statement on Form S-4 containing a proxy statement of Penumbra and a prospectus of Boston Scientific that will contain important information about Penumbra and Boston Scientific, the proposed transaction and related matters. At this point, I'll turn it over to Mike.

Michael Mahoney, Chairman and Chief Executive Officer

Impressive, Lauren. Thank you. Good morning, and 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. Fourth quarter '25, total company operational sales grew 14%. Organic sales grew 13%, achieving the high end of our guidance range of 11% to 13%, with continued 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 $0.80 grew 15%, exceeding the high end of our guidance range of $0.77 to $0.79. Full year adjusted EPS of $3.06 grew 22%, also exceeding the high end of our guidance range of $3.02 to $3.04. On a full year basis, we expanded adjusted operating margins by 100 basis points to 28%, balancing drop-through on the strong revenue performance throughout the year with reinvestment back into the business to drive long-term growth. Now for our 2026 outlook. We expect our differentiated financial performance to continue and are guiding to organic growth of 8.5% to 10% for Q1 and 10% to 11% for the full year. Our Q1 adjusted EPS guidance of $0.78 to $0.80 and our full year adjusted EPS guidance is $3.43 to $3.49, representing leveraged double-digit EPS growth of 12% to 14%, and Jon will provide more details. I'll now provide some highlights on 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, WATCHMAN, and ICTx. Operationally, Europe, Middle East, Africa grew 5% in Q4 and 3% for full year. Excluding the impact of the ACURATE 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 ACURATE 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 FARAPULSE cathode utilization, where we continue to gain share. China had another quarter of double-digit growth driven by EP, WATCHMAN, and ICTx, and we expect EP momentum to continue into 2026, supported by our recent NMPA approval of our FARAWAVE 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. On 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 Neuromodulation franchise. We look forward to expanding our pelvic health portfolio with the 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 sizes 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 midyear 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 coverage for the Intracept Procedure and this at a full market launch of the Intracept EDGE J Stylet, designed to improve the treatment experience. Our Cardiovascular segment delivered 16% growth operationally and organic in fourth quarter and 22% operationally and 21% organic on a full year basis. In January, we announced an agreement to acquire Penumbra, which is expected to close in '26. Penumbra offers a highly differentiated portfolio that operates in high-growth segments for Boston Scientific LAAC's offerings, including mechanical thrombectomy in 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 DCB has been a standout performer all year with this 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 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 '27. In Q4, we did reorganize the reporting structure of our Peripheral Interventions divisions and we've aligned the Peripheral Vascular business led by Cat 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 & Embolization will continue led by Peter Pattison as a stand-alone 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 of 15%. Arterial growth in Q4 was driven by double-digit performance in TCAR supported by the recent launch of ENROUTE in China. And 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 Venous low double-digit fourth quarter growth was driven by continued strength of Varithena and EKOS, and we're pleased to have the high autonomous clinical study in EKOS versus standard of care anticoagulants accepted as a late breaker at ACC to be presented on Saturday, March 28. Our Interventional Oncology & Embolization business grew 17% operationally and 12% organically in Q4 and achieved nearly $1 billion of full year '25 sales, operational growth of 16% and organic of 12%. Q4 organic growth was driven by our category-leading embolization in cancer therapies portfolio with ongoing strength in cryoablation, which treats a broad number of cancer types. Now as we look ahead, we expect to continue to outpace the underlying market growth supported by new product offerings such as TheraSphere 360 Y-90 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 in Q4, we began enrollment in the SYNCHRONICITY trial, evaluating bundle 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 complementary BioEnvelope 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, and we have now treated more than 25,000 patients concomitantly with WATCHMAN. As we look ahead, we continue to invest in our portfolio of 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 AcuNav, intended to offer physicians an innovative imaging option for stand-alone WATCHMAN or FARAWATCH procedures. And last month, we completed enrollment in the SIMPLIFY clinical trial, evaluating 2 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 FLX versus novel oral anticoagulation was accepted and will be presented as a late breaker at ACC on Saturday, March 28. 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. and 25% were done with PFA, with that number closer to 50% globally. Within the quarter, global growth was driven by PFA catheter utilization supported by OPAL placements in 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 U.S. for our FARAPOINT PFA catheter, NAV enabled that can create focal lesions initially indicated for atrial flutter. We're also studying FARAPOINT in the REMATCH AF trial for use in complex procedures with data expected in 2027. We're pleased to have initiated the OPTIMIZE trial studying the Cortex OptiMap mapping technology with the FARAPULSE 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 this leading AF Solutions portfolio and a commercial team and the value to physicians of patients with our concomitant FARAWATCH 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 Jon.

Jonathan Monson, Executive Vice President and Chief Financial Officer

Thanks, Mike. Fourth quarter consolidated revenue of $5.286 billion represents 15.9% reported growth versus fourth quarter 2024. And 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 $0.80 grew 15% versus 2024, exceeding the high end of our guidance range of $0.77 to $0.79. 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%. Post 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 billion shares in the fourth quarter and 1.494 billion shares for full year 2025. Free cash flow for the fourth quarter was $1.13 billion, with $1.364 billion from operating activities less $351 million in net capital expenditures. Full year 2025 free cash flow of $3.659 billion 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 31, 2025, we had cash on hand of $1.96 billion, and our gross debt leverage ratio was 1.9x. Following the announcement of our agreement to acquire Penumbra, all 3 major rating agencies affirmed our A- equivalent credit rating. Additionally, Fitch 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 neuromodulation 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 31, 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 ACURATE 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 the 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 $0.03 headwind from foreign exchange. We expect first quarter adjusted earnings per share to be in the range of $0.78 to $0.80. 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% 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.

Lauren Tengler, Vice President, Investor Relations

Thanks, Jon. 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.

Operator, Operator

The first question comes from Robbie Marcus with JPMorgan.

Robert Marcus, Analyst

Great. I'll ask the question that's on everyone's mind today. Mike, there were concerns that U.S. EP and U.S. WATCHMAN might underperform, and while U.S. EP was steady, U.S. WATCHMAN fell just short. Can you explain what occurred in the quarter compared to your expectations and the market? People are worried because these are two crucial growth drivers. You mentioned confidence in achieving over 15% growth for EP next year, while the market is anticipating around 25%. It seems those expectations may need to be adjusted. Could you clarify what transpired in the quarter and how we should view these two products for 2026?

Unknown Executive, Executive

Thank you, Robbie. Happy to. And I'll touch on your question. Overall, we're super pleased with the quarter. in the full year, growing 60%, EPS growing 22% for the full year. And 6 of our 8 business units growing faster than the market, growing faster than the WAMGR and setting us up for strong guide and investments for the overall company. The 2 businesses that you called out, I think you nailed it. If you look at EP, we're quite pleased. Actually, our results in Q4 exceeded our internal target and WATCHMAN grew 29%. It's pretty much similar to the third quarter as we lap 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. The 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 claim to be 25%. So we think the market was kind of in the 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 the fourth quarter. We grew faster than our peer group based on the percentage that I saw or that we laid out. We actually grew even faster outside the U.S. than in 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 is still healthy. We think it's 18% to 20% in the 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 in the fourth quarter last year. So we're quite proud of the 29%. When you come to the 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 be consensus in the quarter and the full year, and we're quite proud of the EP performance based on the commentary I just provided.

Operator, Operator

The next question comes from Larry Biegelsen with Wells Fargo.

Larry Biegelsen, Analyst

Look, I'm sure there'll be a lot of questions on the US EP business, but I wanted to ask about WATCHMAN. So basically, my question is, can you confirm you're not seeing an impact from the 3 recent trials we saw in 2025? And I want to ask about CHAMPION since it's such an important trial. 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.

Ken Stein, Chief Medical Officer

Yes, I'm looking forward to sharing the results of CHAMPION at ACC, and we'll be holding an investor event that Saturday night at 5:30 p.m. central time where we can dive deeper into the data. There are two co-primary endpoints: one is non-inferiority for the combined endpoint of systemic embolism, and the other is for bleeding. As we saw with OPTION, both will be significant for the field. Regarding your first question, the numbers we reported indicate that we have not seen any impact from the trials, closure alone AF and OCEAN. We continue to observe strong uptake of WATCHMAN in general and specifically in conjunction with other procedures.

Operator, Operator

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

Travis Steed, Analyst

I guess I want to push a little more on US EP, just because it was flat sequentially and your RF competitors grew $18 million and $26 million sequentially in the U.S. So it does look 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 there's 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?

Unknown Executive, Executive

I think we've been quite steady with our messaging on EP. We believe the market is between 18% to 20%, as we previously mentioned, but there may have been some overestimation of market growth in Q4. As the leader in market share for PFA, we anticipated a loss in share due to competitor launches, especially considering our strong position leading into 2025. We expected this outcome. Looking ahead to the end of 2026, we are confident that we will be the clear leader in the EFA market with growth. We project that our EP business will grow at a rate faster than 15%. Given the emerging interest, it's understandable that we lost some share. Nonetheless, the overall EP growth of 35% is quite impressive considering the current size of that business and it has outpaced our competitors. For our first-quarter guidance, we are predicting a full-year growth of 10% to 11%, which we consider strong given our early-year position, even as we project 8.5% to 10% growth for the first quarter due to two main factors. First, we are facing our toughest comparison of the year. Second, there is an estimated impact of around 150 basis points from the discontinuation of ACURATE and a partial withdrawal of AXIOS, affecting the first half of the year. We believe these challenges will be mitigated by June, when the impact of these issues will be reduced, along with our product launches and slightly easier comparisons, although still challenging compared to the first quarter.

Operator, Operator

The next question comes from Rick Wise with Stifel.

Frederick Wise, Analyst

Mike, I hate to focus solely on EP, but could you share your expectations for how 2025 is going to unfold? Perhaps you could discuss the timing throughout the year, particularly regarding the growth acceleration that seems likely to happen as the quarters progress, supported by your innovation pipeline. Additionally, please elaborate on the implications of FARAPOINT and provide updates on ancillary products like ICE catheters. If possible, could you also give us an update on the timing for FARAFLEX? This would help us better understand the situation as we prepare for 2026 and set the stage for 2027.

Unknown Executive, Executive

As we approach the end of 2025, we expect to hold about 65 percent market share in the PFA sector. We believe the market will grow by 15 percent. In the U.S., our utilization is between 70 and 80 percent, while it is significantly lower outside the U.S. With a healthy market, we anticipate that our growth will outpace overall market growth. Though our market share may decrease slightly, we are confident that by the end of the year, it will be comparable to that of all other competitors combined. While we will not provide quarterly share breakdowns, we are assured of maintaining our leadership in the PFA market throughout 2026 and beyond. Factors driving our continued strong growth include our geographical expansion. We are gaining market share in Japan, with ongoing account openings and increased utilization. China, although a smaller part of our current figures, is a major market where we've made significant investments over the past 18 months, which will soon boost our overall global growth. Europe remains highly competitive, yet our growth rate there is impressive, especially with the recent approval of the FARAPOINT catheter. In the U.S., we also see significant advancements from our commercial mapping team, which is gaining more experience and expanding its presence with additional OPAL systems. The FARAPOINT 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'll continue to widen out the portfolio with our Cortex clinical trial work being done, the recent FARAPOINT approval and then we have a whole cadence of new catheters coming over the coming 1 to 3 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 faster than market.

Operator, Operator

The next question comes from Joanne Wuensch with Citibank.

Joanne Wuensch, Analyst

I suspect many of us will be taking through WATCHMAN and FARAPULSE 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 ACURATE. What would you like to highlight to us that you see for a second half accelerating then into 2027, so maybe we can expand our focus just a little bit?

Unknown Executive, Executive

Yes. Great. I think, again, we expect to have a great year in EP and WATCHMAN. We've got the CHAMPION trial coming out. Those results 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. But 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 we expect 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 $1 billion, 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 finished enrollment in our IVL platform for coronary. And importantly, 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 Boston Scientific and of our 8 divisions, 6 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.

Operator, Operator

The next question comes from David Roman with Goldman Sachs.

David Roman, Analyst

I wanted to ask, Mike, if you could just expand 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 WATCHMAN businesses given those will represent a much more significant percentage of growth here on a go-forward basis?

Michael Mahoney, Chairman and Chief Executive Officer

Yes, 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. Urology 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 commercial disruption but we feel comfortable with that. So also with new product launches come into 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 will be important for us once we get through that Axios issue. So a lot of confidence that MedSurg in general should have ideally we plan on a better year than '26 in '26 versus '25. In other businesses, ICTX is a very large business for us now. Our complex coronary business grew 23% in the quarter, and our ICTX business despite the discontinuation of ACURATE grew 10% in the quarter. So that business is doing extremely well with agent and our imaging portfolio. And we have the most product launches and biggest clinical studies in that business. So we continue to diversify and strengthen the ICTX business that's doing quite well. In 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.

Operator, Operator

The next question comes from Patrick Wood with Morgan Stanley.

Patrick Wood, Analyst

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 and I was like how much is that going to help things like seismic in the IVL side and TCAR building out that force in a larger way? And then equally, are there things coming down the pipe 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.

Unknown Executive, Executive

I'm not sure I quite get the question. I would say on the commercial side, we have tremendous scale in our PI business commercially and within our individual 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 the 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-in M&A there. So I think that whole, what we call that ICT area now, we're very bullish on and some of the biggest investments in the company are in that area.

Operator, Operator

Next question comes from Danielle Antalffy with UBS.

Danielle Antalffy, Analyst

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 pretty significant efficiency gains with FARAPULSE and PFA devices overall. Those are probably slowing. 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 talk to sound like they have growing waitlists for their EP procedures and this could only just get exacerbated once CHAMPION comes assuming CHAMPION is positive. So I'm just curious what you could say to that and how much that is currently impacting overall market growth?

Ken Stein, Chief Medical Officer

Yes, Danielle. I think you are absolutely right. We have now reached three years since the launch of FARAPULSE in the U.S. The efficiency gains are largely integrated into the system. As Mike mentioned, we are aiming for 15% growth in the EP market next year. We anticipate that our growth will outpace the overall market. However, I feel a bit odd apologizing for a 15% growth rate in such a significant sector of med tech. The factors driving this growth include the establishment of ASCs in the U.S. to increase capacity and decrease waiting lists, the ongoing development and repurposing of cath labs for EP procedures in hospitals, and our company's efforts to enhance efficiency in procedures. Enhancements in concomitant procedures also contribute to this efficiency. We have discussed several investments we've made, including our partnership with Siemens for the ICE. Until these initiatives are fully realized, we believe that a growth rate exceeding 20% in the market is unlikely, which makes our 15% target a more realistic expectation. Nevertheless, we remain committed to growing faster than the overall market.

Operator, Operator

The next question comes from Michael Polark with Wolfe Research.

Michael Polark, Analyst

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, 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 color.

Unknown Executive, Executive

Yes. We'll give it to 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 in partnership with them, it's really going to be different segments. That will be very much a premium product and markets that can pay for a premium product, and we think it will be differentiated and further differentiate our WATCHMAN and FARAFLEX 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.

Operator, Operator

The next question comes from Matt Taylor with Jefferies.

Matthew Taylor, Analyst

I wanted to follow up on CHAMPION. 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, noninferiority 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 champion result could boost concomitant in the option indication?

Ken Stein, Chief Medical Officer

Yes, to clarify, the bleeding endpoint is designed as a superiority endpoint. We will see what it indicates when we report the results, but the aim is to demonstrate superiority regarding bleeding complications. Achieving superiority on stroke would have required a significantly larger trial, and I don't believe we need to show superiority on stroke. The objective is to establish that WATCHMAN is non-inferior, meaning as effective as the drugs, while being able to show superiority in bleeding. This is what we demonstrated with OPTION, and the impact on that population has been evident. Regarding your second question, if CHAMPION turns out to be positive, it could lead to developing a new indication and also strengthen the current one. A positive CHAMPION result would enhance the value of referrals for the existing indication, which encompasses the OPTION indication. However, it will take time to establish the new indication, improve its representation in guidelines, and revise the CMS national coverage decision. Therefore, if the CHAMPION results are positive, it would not only contribute to growth in WATCHMAN but also help sustain that growth in our long-term plans.

Operator, Operator

The next question comes from Josh Jennings with TD Cowen.

Joshua Jennings, Analyst

Mike, it hasn't been long since the Investor Day, and I wanted to understand your confidence in achieving your long-range plan targets through 2028, particularly the goal of over 10% organic growth. It seems clear from this call that you're confident about reaching the 2026 guidance. Do you have any updates on your confidence regarding the long-range plan and the target for double-digit organic revenue growth?

Michael Mahoney, Chairman and Chief Executive Officer

Yes, 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-digit growth even within that. And then we think Penumbra further enhances our WAMGR and further strengthens the company beyond that. So really no change in position here. Our whole key to our business is being in fast-growth markets, which we've demonstrated we anticipate in that time horizon, excluding Penumbra, we're very comfortable with those LRP goals as we've stated.

Operator, Operator

And I understand there's time for one last question, I have that from Chris Pasquale with Nephron Research.

Christopher Pasquale, Analyst

I believe you mentioned that U.S. PFA penetration is already at 70%, which is slightly higher than we had anticipated. This suggests we may be nearing the later stages of that mix shift. I would appreciate your insights on what remains to be penetrated with TSA, especially as we consider other procedure categories like SBT or VT, and what will be needed from both a product and data standpoint to effectively enter those segments.

Ken Stein, Chief Medical Officer

Yes. Thanks, Chris. Again, I think, first of all, right, the 70% penetration is still 30% left to penetrate. And 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 2 prime use cases where we would see a real advantage to moving to PFA would be for atrial flutter, 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 FARAPOINT catheter and FARAFLEX catheter, which is in development now, and we're very pleased with the progress of that in its first human use studies. But that is one of the areas and I think those catheters and those form factors are going to shine.

Lauren Tengler, 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. Thank you, everyone.

Operator, Operator

Please note, a recording will be available in one hour by dialing either 1 (877) 344-7529 or 1 (412) 317-0088 using replay code 7215110 until February 11, 2026, at 11:59 p.m. Eastern Time. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.