Earnings Call Transcript
BOSTON SCIENTIFIC CORP (BSX)
Earnings Call Transcript - BSX Q3 2025
Operator, Operator
Good morning, and welcome to the Boston Scientific Third 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; 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 Q3 results, which included reconciliations of the non-GAAP measures. 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 Nalu Medical, which is expected to close in the first half of 2026, subject to customary closing conditions. For more information, please refer to the Q3 financial and operating highlights deck which may be found on 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 of today's date and are not intended to be guarantees of future events or performance. If our underlying assumptions turn out to be incorrect or certain risks or uncertainties materialize, actual results could vary materially from those projected by the forward-looking statements. Factors that may cause such differences are discussed in our periodic reports and other filings with the SEC, including the Risk Factors section of our most recent annual report on Form 10-K. Boston Scientific disclaims any intention or obligation to update these forward-looking statements, except as required by law. At this point, I'll turn it over to Mike.
Michael Mahoney, Chairman and Chief Executive Officer
Thanks, Lauren. Thank you to everyone for joining us today. Our quarterly results again exceeded our expectations led by our innovative portfolio, strong execution and a winning spirit of our global team. In the third quarter of '25, total company operational sales grew 19% and organic sales grew 15%, exceeding the high end of our guidance range of 12% to 14%, with sustained high performance in both our Cardiovascular and MedSurg segments. Q3 adjusted EPS of $0.75 grew 19%, exceeding the high end of the guidance range of $0.70 to $0.72. Q3 adjusted operating margin was 28%. Turning to our fourth quarter and full year '25 outlook, we are guiding to organic growth of 11% to 13% for fourth quarter '25, which implies an increase to our full year '25 guidance to approximately 15.5%, reflecting our confidence in sustained above-market growth. Our fourth quarter adjusted EPS guidance is now $0.77 to $0.79, and we are thus raising our full-year adjusted EPS guidance to $3.02 to $3.04, representing growth of 20% to 21%. Jon will provide more details in the financial section. I'll now provide some additional highlights on our third quarter results and outlook. Regionally, on an operational basis, the U.S. grew 27% with impressive growth. This excellent growth is broad-based across our Cardiovascular businesses, Endoscopy and Neuromodulation. Europe, Middle East and Africa did decline 2% on an operational basis as a result of two impactful yet transient headwinds in the quarter. First, the discontinuation of our ACURATE valve in May '25, which had prior year third quarter sales of approximately $50 million. And secondly, we implemented our upgraded ERP system mid-quarter at our Kerkrade distribution center. This did result in a backorder of approximately $30 million impacting a number of our businesses in Europe. We do anticipate this backorder will improve throughout the fourth quarter. Excluding these two headwinds, EMEA growth would have been high single digits driven by strong double-digit growth in EP and continued high utilization of FARAPULSE and double-digit growth in complex PCI. Asia Pac grew 17% operationally led by strong double-digit growth across Japan and China. Japan growth was driven by WATCHMAN and EP, which saw excellent performance in the quarter led by FARAPULSE, which recently received expanded labeling for persistent indication and was supported by our OPAL HDx mapping system. China grew an impressive mid-teens despite the substantial VBP in our peripheral business. China growth was broad-based and driven again by growth in ICTx and EP. Within the quarter, we received NMPA approval for the WATCHMAN FLX Pro device and recently began commercial launch, which coupled with FARAPULSE and investment in clinical evidence such as OPTION-A, drives our confidence in sustained mid-teens growth over the LRP in China. I'll now provide some additional commentary on our business units, starting with Urology. Urology sales grew 27% operationally and 5% organically. Growth in the quarter was driven by international business and a global Stone Management franchise. Axonics performance continues to be below expectations as we are focused on improving our commercial execution post the unplanned commercial disruption. However, we remain enthusiastic about the SNM market opportunity and our future focus on strengthening the commercial team, patient activation and globalization opportunities. We're pleased to have recently received approval for Axonics F15 in Europe. Our outlook for the Axonics business, coupled with our broad innovation cadence across the business, drives confidence in our expectation that Urology growth will improve throughout 2026. Endoscopy delivered an excellent quarter, growing 9%, driven by double-digit growth in key products, including AXIOS, MANTIS and OverStitch combined with our differentiated broad portfolio. Notably, the U.S. grew 11% led by the recent launch of WallFlex PLUS and above-market growth across the pancreaticobiliary franchise. Neuromodulation had a strong quarter as sales grew 9%. Our brand franchise grew low double digits, supported by the 5-year results from the INTREPID study, which demonstrated sustainable benefits of DBS in patients with moderate to advanced Parkinson's disease. The pain franchise continues to strengthen and grew high single digits, led by strong double-digit growth in the U.S. with Intracept. The team is in the early stage of launching Intracept in Europe. We also just announced our agreement to acquire Nalu Medical which we anticipate will expand our portfolio into a new pain adjacency in peripheral nerve pain. This is an excellent new growth opportunity and complements our commercial strength with the interventional pain position. We expect this transaction to close in the first half of 2026. Peripheral Interventions sales grew 16% operationally and 6% organically with excellent low double-digit growth in the U.S. that was offset by the China VBP. Within our peripheral vascular business, we saw low single-digit decline in arterial, again, driven by the China VBP. During September, Silk Road turned organic and delivered improved high single-digit pro forma growth within the quarter, supported by the recent launch of ENROUTE in China. Looking forward, we continue to expect a very limited launch of SEISMIQ IVL for peripheral above-the-knee procedures by year-end 2025, an increase in launch cadence in '26, with an increase in launch cadence in '27. In venous, we saw excellent double-digit growth led by continued strength in Varithena and EKOS. Within the quarter, HI-PEITHO, our clinical study with EKOS versus standard-of-care anticoagulants completed enrollment, and we expect data to be presented in 2026. Our Interventional Oncology & Embolization business grew double digits, driven by our category-leading embolization and cancer therapies portfolio with notable strength in cryoablation, which treats a broad number of cancer types. Clinical evidence remains a key enabler for future growth, and within the quarter, we completed enrollment in two important trials. ROWAN, which studied TheraSphere in combination with AstraZeneca's STRIDE regimen for patients with HCC and OCCLUDE, a large real-world registry for OBSIDIO Conformable Embolic. Cardiology delivered another outstanding quarter, with sales growing 23%. Within Cardiology, interventional cardiology therapy sales grew 3%, which does include the impact of the ACURATE withdrawal. With double-digit growth in coronary therapies, driven by AGENT Drug-Coated Balloon in the U.S. and our imaging catheters globally. The U.S. grew 21%, led by AGENT DCB, where we continue to expect strong growth supported by the New Technology Add-on Payment that was recently approved and went into effect October 1. In the long term, we're investing to expand the indicated patient population with evidence from our STANCE trial evaluating AGENT versus standard of care in de novo lesions, which began enrollment in August. We continue to be excited about the addition of SEISMIQ IVL to our leading coronary therapies portfolio and expect completion of the FRACTURE trial in the first quarter of '26. We expect to launch this differentiated technology in the U.S. in early '27 further expanding our SEE, PREP, TREAT approach across our portfolio. Cardiac Rhythm Management sales grew 2%. Our Diagnostics franchise grew low double digits, led by continued above-market performance with our LUX ICM device. In Core CRM, our low-voltage business grew low single digits with the momentum from the launch of our Conduction System Pacing tools in the U.S. and Europe, while our high-voltage business declined low single digits. We recently closed the acquisition of the Elutia BioEnvelope assets, which are designed to prevent postoperative complications for devices such as pacemakers and defibrillators. We look forward to expanding the reach of this technology to more global markets as a complement to our Core CRM portfolio. WATCHMAN grew an outstanding 35% this quarter and surpassed 600,000 patients targeted to date. The excellent growth in the quarter reflects accelerated concomitant uptake in the U.S. and continued penetration into the 5 million patients indicated today through excellent clinical results and strong patient and physician awareness. We continue to expect approximately 25% of the U.S. WATCHMAN procedures to be done concomitantly exiting '25 with a potential for that to double by 2028, enabled by the trusted FARAWATCH approach. We are confident that we can continue to grow the WATCHMAN market by approximately 20% for the years to come driven by continued concomitant uptake, the upcoming data presentation of CHAMPION in the first half of '26 and the launch of our next-generation device, WATCHMAN Elite, expected in late '27 or early '28. Turning to EP. We're incredibly proud of our EP performance, with third quarter sales growing 63% as we drive continued share gains in the overall EP market. FARAPULSE remains the leading PFA technology having treated over 500,000 patients to date with consistent and reproducible real-world results, further demonstrated in the recently published 1-year results from the FARADISE trial, which showed favorable procedural and safety outcomes and clinical effectiveness across ablation strategies and AF types. In the U.S., we saw continued strong double-digit growth in FARAPULSE supported by ramping adoption of our OPAL HDx mapping system, with one in three FARAPULSE accounts now utilizing our integrated FARAWAVE NAV and OPAL device. The team is executing our pipeline strategy, and we recently launched our contact sensing feature and are moving to full release this month. Looking forward, our aim is to continue to grow our share in the overall EP market, and we expect to retain a strong leadership position in PFA, enabled by our innovative portfolio, expanding mapping and commercial resources and consistent data publications. We expect global PFA penetration to continue to expand and to exit 2025 at 50% penetration and grow to approximately 80% by 2028. At our recent Investor Day, we shared that we aim to be the market share leaders, not just in PFA but the overall EP market over time. We are investing today to outpace the approximately 15% market growth expected through '28 by advancing our ecosystem of innovative solutions across both the AF and non-AF segments of the market. We are simplifying ablations and the workflows associated with them and expanding patient access through clinical evidence generation across the globe. By year-end '25, we expect to make meaningful progress towards expanding access to new technologies in more complex and redo patients with the launch of our FARAPOINT PFA catheter as well as initiating enrollment in the OPTIMIZE trial, which will study the integration of OPAL in the Cortex AI algorithm. Cortex is a differentiated mapping software designed to precisely visualize and target sources of arrhythmias, addressing an unmet need in the treatment of persistent AF patients with unexplained recurrence. In closing, I look forward to finishing out an outstanding 2025 and delivering on our guidance, which will result in another year of delivering highly differentiated financial results versus our peer group. And as we highlighted at our recent Investor Day, we have an incredibly strong global team that is relentlessly pursuing and investing in meaningful innovation to deliver differentiated growth and leverage EPS growth this year and for years to come. And with that, I'll hand over to Jon to provide more details on our financials.
Jonathan Monson, Executive Vice President and Chief Financial Officer
All right. Thanks, Mike. Third quarter consolidated revenue of $5.065 billion represents 20.3% reported growth versus the third quarter of 2024 and includes a 90 basis point tailwind from foreign exchange, which was favorable versus our expectations. Excluding this $38 million foreign exchange benefit, operational revenue growth was 19.4% in the quarter. Those acquisitions contributed 420 basis points to sales, resulting in 15.3% organic revenue growth which was above our third quarter guidance range of 12% to 14%. Q3 2025 adjusted earnings per share of $0.75 grew 19% versus 2024, exceeding the high end of our guidance range of $0.70 to $0.72, primarily driven by strong drop-through on above-expectation revenue and margin performance in the quarter. Adjusted gross margin was 71% for the third quarter representing a 60 basis point improvement versus the third quarter of 2024, primarily due to favorable product mix, driven by strong growth in electrophysiology and WATCHMAN and partially offset by tariffs. As a result of our Q3 performance, we now anticipate full year adjusted gross margin to slightly improve versus 2024, inclusive of an approximate $100 million tariff headwind for the full year, unchanged versus previous expectations. Third quarter adjusted operating margin was 28%, expanding 80 basis points versus the prior year period, driven by strong drop-through on our top line performance. On a GAAP basis, third quarter operating margin was 20.7%. Moving to below the line, third quarter adjusted interest and other expenses totaled $116 million, which was in line with our expectations. On an adjusted basis, our tax rate for the third quarter was 13.6%, and our operational tax rate was 13.9%. Fully diluted weighted average shares outstanding ended at 1.495 billion shares in the third quarter, and free cash flow for the third quarter was $1.163 billion with $1.343 billion from operating activities less $181 million in net capital expenditures. We continue to expect a full-year 2025 free cash flow to be approximately $3.5 billion, reflecting strong cash conversion driven by earnings growth and disciplined working capital management. As of September 30, 2025, we had cash on hand of $1.275 billion, and our gross debt leverage ratio was 2.0 times. Our top capital allocation priority remains strategic tuck-in M&A in high-growth adjacencies, followed by share repurchase. In alignment with this strategy, we recently closed our acquisition of the Elutia BioEnvelope assets and announced our agreement to acquire Nalu Medical. Our legal reserve was $306 million as of September 30, with $46 million already funded through our qualified settlement funds. I'll now walk through guidance for Q4 and full year 2025. We expect full year 2025 reported revenue growth of approximately 20%. Excluding an approximate 100 basis point tailwind from foreign exchange, we expect full year 2025 operational revenue growth of approximately 19%. Excluding an approximate 350 basis point contribution from closed acquisitions, we expect full year 2025 organic revenue growth of approximately 15.5% versus 2024. We expect fourth quarter 2025 reported revenue growth to be in the range of 14.5% to 16.5%. Excluding an approximate 200 basis point tailwind from foreign exchange, we expect operational growth to be in a range of 12.5% to 14.5%, and excluding an approximate 150 basis point contribution from closed acquisitions, we expect fourth quarter 2025 organic revenue growth to be in a range of 11% to 13% versus 2024. As a result of our year-to-date margin performance, we now expect to expand full year adjusted operating margin by approximately 100 basis points at the high end of our prior range of 75 to 100 basis points, and we continue to expect full year 2025 adjusted below-the-line expense to be approximately $440 million. We also maintain our forecast for a full-year adjusted tax rate of approximately 12.5% and an operational tax rate of approximately 14%. We expect full year adjusted earnings per share to be in the range of $3.02 to $3.04, representing growth of 20% to 21% versus 2024. We continue to expect an approximate $0.04 foreign exchange headwind on full year adjusted earnings per share. And for Q4, we expect adjusted earnings per share to be in a range of $0.77 to $0.79. In closing, I'm pleased with our strong third quarter financial performance and look forward to executing on our full year 2025 guidance and our long-range financial goals, which we shared at our recent Investor Day. From 2026 to 2028, we're targeting 10% plus average organic revenue growth, approximately 50 basis points of annual adjusted operating margin expansion, leveraged double-digit adjusted earnings per share growth and 70% to 80% annual free cash flow conversion. We feel that these goals represent differentiated performance in medtech, and we look forward to executing on them. Thank you all for joining us today. For more information, please check our Investor Relations website for the third quarter 2025 financial and operational highlights, which provides more details on our results and updated guidance. And with that, I'll turn it back over to Lauren, who will 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
Thank you. We will now begin the question-and-answer session. The first question comes from Robbie Marcus with JPMorgan.
Robert Marcus, Analyst
Congrats on a really good quarter here. One for me. And Mike, this comes on the tail of what was a really bullish Analyst Day. And I think what's really coming through in the discussion this morning with investors is EP has been a phenomenal growth driver, but WATCHMAN is really what's the most exciting, at least from the print today and the incremental upside, that you're continuing to see an acceleration here off the back of concomitant and the OPTION data in the fall of last year. So the question is really, do you think of WATCHMAN as a key growth driver? And how do you think people should really expect growth and dollar contribution to progress, assuming the CHAMPION data is positive, just given how much this market has exploded and still how low penetration is potentially versus the addressable population?
Michael Mahoney, Chairman and Chief Executive Officer
Well, thank you very much, Robbie. We're super pleased with the overall performance for the global company. And you pointed out two excellent performers in EP and WATCHMAN. WATCHMAN clearly is a gem for Boston Scientific. We essentially created the market through great clinical evidence, and you saw at Investor Day a really strong portfolio going for the future, along with expanding evidence in the big CHAMPION trial to be read out first half 2026. And concomitant really continues to exceed expectations. It's been adopted very quickly. Now we expect 25% of the WATCHMAN procedures to be done concomitantly. So that's certainly a tailwind for us. And the whole combination of FARAPULSE and WATCHMAN together in that procedure is really becoming standard of care for hospitals and physicians given the safety profile and trust they have in that solution along with our excellent commercial teams. So in framing the market, kind of similar to what we said at Investor Day, we're comfortable with a 20% market CAGR over the LRP, given the strong momentum of WATCHMAN, the underserved patient population that we continue to focus on. Also the globalization of WATCHMAN, we saw some good news in China in the quarter with the approval of FLX Pro, which will help China really strengthen their performance in 2026. So there's just a lot of great things going on with WATCHMAN in terms of the concomitant procedure itself, the trust that the community and referrers have in the concomitant procedure, the tremendous pipeline of patients that are still very underserved, and the resources and investment that we're placing in additional portfolio enhancements in clinical to broaden it out. We have a very unique strong market share in WATCHMAN, and we plan to continue that market share strength that we have while this market continues to grow very quickly.
Operator, Operator
The next question comes from Joanne Wuensch and Citibank.
Joanne Wuensch, Analyst
And may I also say very nice quarter. I'd like to step back just for a second and get your impression on two sort of bigger items that are impacting medtech. One is China; it sounds to me like your China business is doing just fine. But obviously, would love your view. And second of all, we sort of picked up that there may be some procedures that are being pulled forward as people think about Affordable Care Act cuts and Medicare cuts as we look forward. And I'd love to see or hear what you're seeing in those things.
Michael Mahoney, Chairman and Chief Executive Officer
Sure. And the first one, procedure pull forward, we don't have any signals that would indicate we're seeing procedural pull forward across our businesses. So that's something we'll watch out for. But I would say we did not see that in the third quarter, more of a consistent procedural demand that we expected and continue to expect going forward. I think China shows the really the winning spirit of our global team and the strength of our team in China and really just the innovation focus that we have across Boston Scientific is represented well in China as we continue to differentiate ourselves versus our peer group there. In the quarter, we again grew mid-teens. We indicated at the Investor Day, we are comfortable with double-digit growth across the LRP, even though that business is getting much larger for us. And as we've mentioned before, we are able to continue to offset VBP price pressures with new innovation and new launches in our combined portfolio, combined with expanding our reach of our customer coverage across the China opportunity. So we have a broad base of business there. Years ago, it was solely ICTx, but the ICTx business is our largest business there. They do extremely well. The imaging business with ICTx has done remarkably well and is growing quite well. And the EP business had a nice quarter, and we expect bigger things out of the China EP business in the fourth quarter and as we go into 2026. So that will provide some additional tailwind, and WATCHMAN FLX Pro is also a big launch for us as our WATCHMAN business has been slower in '25 without that product. So we do see EP, WATCHMAN and ICTx continue to carry and offset the VBP headwinds that we face, and that's why we're comfortable with the double-digit growth going forward.
Operator, Operator
The next question comes from Larry Biegelsen with Wells Fargo.
Larry Biegelsen, Analyst
I'll echo my congratulations on another really nice quarter here. I wanted to follow up on Ravi's question on WATCHMAN and the LAA market. I think some investors were surprised by the 20% market outlook you provided at Investor Day, given the growth we're seeing today, which is much higher, and we have CHAMPION coming in the first half of next year. So my question is, is there anything you're seeing in studies like ALONE-AF and OCEAN that's coming at American Heart that concerns you? And maybe just lastly, Dr. Stein, how much of a read-through will CLOSURE-AF at American Heart be to CHAMPION?
Michael Mahoney, Chairman and Chief Executive Officer
I would say at a high level, hopefully, you appreciate that we do like to provide accurate forecasts as we can on market growth, but we also like to deliver and exceed our commitments. I think that's really important for our team and our investors. And I think, Ken, you can speak to the more substantial part of the question.
Ken Stein, Chief Medical Officer
Thank you, Mike and Larry. I want to emphasize that projecting a 20% growth over several years as part of our long-range plan is conservative, reflecting the significant impact that WATCHMAN has had and will continue to have. As mentioned earlier in response to Robbie's question, the currently indicated population is still vastly underpenetrated, which reinforces our confidence in achieving that 20% growth. Regarding the upcoming studies, let's start with CLOSURE, which will be reported at the AHA. However, I don't believe it provides much relevant insight for CHAMPION since it involves a different European population, has a different primary endpoint, and a shorter follow-up period. We remain optimistic about other trials like PRAGUE-17 and OPTION, which bolster our expectations for CHAMPION. With respect to ALONE-AF and the OCEAN trial, if OCEAN confirms ALONE-AF, it would suggest that low-risk patients undergoing AF ablation may no longer require stroke prevention, which is positive. It's important to note that until now, AF ablation was typically indicated primarily for patients experiencing significant symptoms from their atrial fibrillation. This supports the growth of FARAPULSE as more patients pursue AF ablation to discontinue blood thinners. However, the current patients undergoing concomitant FARAWATCH procedures are not the low-risk individuals studied in ALONE-AF, and we haven't observed any significant impact on those procedures following ALONE's publication. Considering all of this—the significantly underpenetrated indicated population, the potential for indication expansion with the CHAMPION trial, and the ongoing growth in AF ablation—we feel very confident in our projection of 20% annualized growth over the long-range plan.
Operator, Operator
The next question comes from Rick Wise with Stifel.
Frederick Wise, Analyst
I'd like to focus on the very impressive margin performance. Jon, you kept saying strong drop-through to margins from the revenue outperformance, got it. But I was hoping you'd sort of give us a little more color. I mean your gross margins, which I know you don't guide to specifically, almost back now to pre-COVID levels. Help us think through as we try to model, looking ahead, where do we go from here on the margin front? How big a driver of your operating margin goals is gross margin? And just help us understand maybe with a little more color, the drivers from here. It just feels like given the revenue strength and what we saw this quarter that your 50 basis point annual improvement could prove conservative. He said optimistically.
Jonathan Monson, Executive Vice President and Chief Financial Officer
Thank you, Rick, for your question. I'm satisfied with our quarterly performance and our goal to increase operating margins by 100 basis points for the year, despite a $100 million tariff impact we've anticipated. In this quarter, we experienced substantial gross margin benefits from our product mix, particularly with WATCHMAN showing 35% growth and EP also performing well. As Mike pointed out earlier, our AGENT drug-coated coronary balloon is doing exceptionally well, contributing to our mix advantage. We expect gross margins to improve year-over-year even with the tariff challenge. Looking ahead to next year, we are currently finalizing our annual operating plan and will share more details during our Q4 call at the beginning of next year. As mentioned during our Investor Day, we aim to increase operating margins by about 50 basis points annually, with mix continuing to support gross margins. However, we anticipate the annualization of tariffs will pose an additional challenge in 2026. We plan to maintain leverage through SG&A while investing in R&D at approximately 9% to 10%, which is competitive within our industry. I appreciate your question, Rick. I am encouraged by our business momentum and financial results while continuing to invest in future growth. We will provide further details during our upcoming Q4 call.
Operator, Operator
The next question comes from David Roman with Goldman Sachs.
David Roman, Analyst
Mike, you referenced this in response to one of the earlier questions, but I was hoping you could expand on the dynamics in the business, kind of outside EP and WATCHMAN. There's obviously a disproportionate focus on those businesses given how strong a growth contribution they've been. But as we look forward, I think everyone understands that the EP business is going to decelerate given just the size and the competitive landscape there, even with strong market growth. But if you look across the rest of the portfolio, you're seeing good momentum in businesses like Neuromodulation and Endoscopy. You talked about some of the improvements you're seeing in Silk Road. But maybe help frame for us what are kind of the drivers that support the growth outlook in the rest of the business? And where you think from a product perspective, we should be focused?
Michael Mahoney, Chairman and Chief Executive Officer
David, thank you for the question. A lot of focus is rightly on our EP business, which has moved from being fourth to a clear second place and aims to improve further in the future. However, as you mentioned, we anticipate slower growth due to anniversary comparisons and the business's scale. We do expect our EP business to perform exceptionally well in 2026 and beyond. I am also very proud of our other divisions. Not every business grows faster than the market every quarter, but as a whole, we clearly do, and we've communicated that we intend to grow beyond our 9% WAMGR. In the last quarter, our MedSurg business achieved a solid 8% growth, largely driven by our Endoscopy segment, which has several alliances and product launches planned for 2026, promising strong performance. The Euro region faced challenges this year, but we have optimistic expectations there, especially regarding Axonics, which we expect will strengthen in the fourth quarter and throughout 2026. Additionally, Euro will face easier comparisons in 2026, allowing for growth acceleration. I'm also proud of our Neuromod team, which achieved 9% growth last quarter. We've recently signed the Nalu acquisition, which complements our portfolio well and strengthens our leadership in the pain management category alongside a robust SCS business. Relievant has exceeded our expectations following that acquisition, and with Nalu, we have the most extensive portfolio in Neuromodulation, allowing us to effectively serve our customers. Our ICTx business has shifted from being heavily reliant on DES to becoming a high-growth segment led by our imaging solutions and AGENT, complemented by the entire portfolio. We made our largest investments in ICTx, including the upcoming limited launch of our IVL product for PI at the end of this year, with full benefits expected in 2026. The IVL trial in cardiology is progressing very well, and we aim to conclude it early in the first quarter of 2026, leading to a launch early in 2027. Our IO segment continues to excel with double-digit growth, and our venous portfolio also grew in double digits while adapting to pricing challenges in China. Although EP garners the most attention, the rest of the business is thriving. It's crucial that we consistently invest time and resources into these areas through organic R&D, strategic acquisitions, and expanded clinical efforts to maintain growth above market rates as our WAMGR continues to rise.
Operator, Operator
The next question comes from Travis Steed with Bank of America. Excuse me, Mr. Steed, is your phone muted accidentally? Please go ahead with your question, sir. We'll go to the next question. It comes from Michael Polark with Wolfe Research.
Michael Polark, Analyst
I have a question on PFA and persistent. So FARAWAVE got the FDA label for persistent in July. I'm hoping you can confirm FARAPOINT is on track for year-end 2025. If both of those things are true or FARAPOINT still on track, like is this the cocktail to get the penetration of PFA into persistent kicked into a higher gear? I hear about 50% PFA penetration at a high level, but I think that's a much higher rate of pen into paroxysmal or de novo cases and lower into more complex cases, including these persistent patients. So I'm just kind of interested, is '26 the year where persistent really kicks into a higher gear? And if not, what is the cocktail to enable that?
Ken Stein, Chief Medical Officer
Yes, Mike, I'll take that. And I actually, particularly for de novo persistent, it's already in high gear. We got that approval on the back of the results of our ADVANTAGE trial, which frankly showed the best long-term outcomes anyone has ever seen in a de novo persistent ablation trial and really remarkable long-term freedom from high burden persistent atrial fibrillation or from symptomatic atrial fibrillation. And one of the things that I don't know that everyone has appreciated enough to this point is that if you look at the results of trials like ADVANTAGE as well as some of the real-world data now that we've presented at meetings, the redo rates after de novo persistent AF ablation with FARAPULSE are down into the single-digit levels. And so I think I would not agree with the characterization today of de novo persistent as a particularly complicated ablation. The FARAWAVE catheter is just exquisitely well suited for this ablation strategy of pulmonary vein isolation plus posterior wall ablation. I think I would agree with your premise when you get to the more complex things like redo procedures. And that's where things like having FARAPOINT as an adjunct, we get to things like our FARAFLEX catheter that's in first human use clinical trials today as well as things like the acquisition that we had of the Cortex technology, as Mike mentioned in the script, to enable a true precision mapping of AF sources so that you do have something that you can offer to those, again, single-digit number of patients who are going to have unexplained recurrences after their de novo ablation. But just to come back to it, we really already do see a very high degree of uptake of FARAWAVE in the de novo persistent population and expect to see that continue.
Operator, Operator
And the next question comes from Travis Steed with Bank of America.
Travis Steed, Analyst
Congrats on a successful quarter, and I'm back after finishing my fantasy draft. I wanted to inquire about the $30 million backorder mentioned. Although it's a small figure, it could contribute to overall company growth. Which areas were affected by this, and was there a particular segment that felt the impact the most during the quarter? Will we see this recover in Q4?
Michael Mahoney, Chairman and Chief Executive Officer
Thank you for the question. This is a comprehensive global ERP implementation that we began a few years ago, specifically at our Kerkrade distribution facility, which did not go as planned. However, the team is doing an excellent job recovering from that, and things are certainly looking better now compared to 60 days ago. I appreciate our team's hard work in that area. The impact this quarter was quite broad-based, leaning more towards the MedSurg and PI businesses. It affected many areas, with less impact on EP and the WATCHMAN division, but more on the others. The team has made significant progress. While we are not completely out of the woods regarding the backorder, we anticipate it will decrease to acceptable levels by the end of the year.
Operator, Operator
The next question comes from Patrick Wood with Morgan Stanley.
Patrick Wood, Analyst
I would like to explore Nalu further since it's quite new and you're currently involved. PNS is definitely an intriguing market with very few competitors. I understand that the other players are quite small. What convinced you that this is the right time to act? You have been monitoring them closely for some time, so I would appreciate any additional insights on your strategy for expanding there and particularly how you plan to enhance commercial coverage over time.
Michael Mahoney, Chairman and Chief Executive Officer
Yes. We're, as I mentioned, excited about the Nalu signing. In terms of timing, like many companies that we end up acquiring, we're a VC investor in Nalu when Keegan Harper and team started this many, many years ago. So we always liked the space of peripheral nerve stim. The Nalu team did a really nice job over many years, building up the portfolio, driving the clinical evidence, where now they have solid Medicare reimbursement and improving coverage from the commercial payers. So a nice job in terms of clinical evidence, which is driving the reimbursement and also solid clinical performance and solid sales track record. I think just as importantly, we always look at in our integrations, is it the right time for the business to integrate Nalu. And our Neuromod team with Jim Cassidy, has done an amazing job, Brian Betts and others with Relievant that we acquired, I don't know, 18 months ago or so, which also is a very unique asset in that pain space and what's driving considerable growth for the company. And so the team proved they can drive the integration successfully, and they're ready to take on more, and we had a large VC investment in this business. So it's a perfect puzzle piece to add to our neuromodulation and pain business. Because it really does offer a highly differentiated portfolio versus our others who primarily compete in spinal cord stim. And this is another new adjacency that will add to our WAMGR and accelerate the growth of Neuromod in '26.
Operator, Operator
The next question comes from Danielle Antalffy with UBS.
Danielle Antalffy, Analyst
Congrats on a good quarter. Mike, I also have to admit to you that you were right about the raters. So with that, my question is on CRM. And that's been a business where you guys have been growing below the market. You have a competitor that's in a new product cycle, and they're actually talking about sustainable double-digit growth going forward. You guys have a new product cycle coming. So I'm just curious about how you think about the cadence of growth in that business as we start to get into the launch of some of those new products.
Michael Mahoney, Chairman and Chief Executive Officer
We are pleased with our performance in the LUX segment, which is a smaller part of the market but continues to do well. We have invested for several years in a new platform called Denali, which will see different launch stages towards the end of the second half of 2026 and into the long-range plan period. Ken can provide more details on this complete refresh, which we believe will enhance our core pacemaker defibrillator business. We are also excited about EMPOWER, our entry into the leadless pacemaker market combined with S-ICD. While we have been growing at market rates in unit sales, our dollar sales have lagged due to gaps in leadless products that drive higher average selling prices. Nonetheless, we are maintaining our growth in units, and we are confident that our CRM business will strengthen during this long-range plan period and become a larger contributor for us.
Ken Stein, Chief Medical Officer
Yes. Maybe I'll just add to what Mike said. I mean, again, we certainly do have a gap in not being in the leadless market, excited about eventually being able to bring the EMPOWER device to market; see that as important both as playing in leadless but also as something that's going to be an enabler for accelerated growth within our S-ICD franchise. I'd also point to the acquisition of Elutia. This is an important adjunctive technology that people are using to prevent complications, in particular, things like postoperative infections or postoperative complications with the pockets for these devices. That's another market that we have not played in previously, and it's one where we have a technology that we really do see as having differentiated advantages over the incumbents. Mike mentioned our complete refresh of our entire implantable platforms, brady, high-voltage, CRT and S-ICD. So that's sort of a generational opportunity to really develop market-leading technology across all of those platforms. And I think that also highlights where we've gone with the Conduction System Pacing, seeing fantastic growth in the use of our Conduction System Pacing technology for pacemakers for brady indications, but also very excited to have a purpose-built ICD lead for doing Conduction System Pacing in a tachy market that we think would be quite disruptive.
Operator, Operator
The next question comes from Vijay Kumar with Evercore.
Vijay Kumar, Analyst
Congratulations on the nice print. Jon, maybe one for you on a margin share. When I look at fiscal '25, you had the TAVR recall charges in tariff. Despite that, we're at 100 basis points of margin expansion, right? But when you look at the cadence, I think Q4 is down sequentially, right? Is that the incremental tariff headwind from Q3 to Q4? And how should we think of fiscal '26, right? Is the Analyst Day had 50 bps of annual OMX, is that still relevant for '26?
Jonathan Monson, Executive Vice President and Chief Financial Officer
Yes. Thanks, Vijay, for the question. And yes, pleased with our expectation for improving margins 100 basis points on the year despite the tariff headwind of roughly $100 million. And as you mentioned, we had the impact of the ACURATE withdrawal in the second quarter. So despite that, I think we've done a nice job with finding appropriate offsets in the business, driving strong margin expansion, predominantly with the top line performance that we've seen for the year, again, expecting 15.5% organic revenue growth and reinvesting back into targeted areas of the business to drive growth for the long term. So yes, we'll see where we go for the fourth quarter. We manage margins really on an annual basis. So we're a little less focused quarter-by-quarter, more focused on how we're driving margin performance for the year. And as far as 2026, we're rolling up the plan process now, and we'll provide much more detail there when we get to the Q4 call at the early part of next year. But you should expect us to expand operating margins and drive meaningful expansion there and deliver leveraged double-digit EPS growth.
Operator, Operator
The next question comes from Chris Pasquale with Nephron Research.
Christopher Pasquale, Analyst
I wanted to ask about AGENT. Our work suggests that launch is going really well. The product has a chance to be maybe a $1 billion product for you as the indication expands, although it's not getting the kind of attention yet. I'm curious how you're thinking about growth in the interim period before STANCE reads out? Is there enough room just in ISR to sustain the current momentum, especially with competition maybe coming into the U.S. next year? And while I know you don't promote off-label use, are you starting to see physicians already moving beyond in-stent restenosis and utilizing the product in de novo lesions?
Ken Stein, Chief Medical Officer
Yes, Chris, maybe I'll take that. The fast answer is yes, we do see plenty of room for continued growth even before STANCE completes enrollment and reads out. We're pleased now to have a TPT and better reimbursement in place. I think to point out, we also, with trials like STANCE, see an opportunity to at least double the indicated population as you move beyond in-stent restenosis into small vessel bifurcation disease and some other de novo lesions. We will have some additional data on AGENT coming out of TCT, data from our AGENT post-approval study. And I think that will be helpful as you all do kind of see the sorts of lesions that it is being used for in the real world and see the real-world outcomes. In terms of competition, I think getting more data out about the use of drug-coated balloons is good for us and good for AGENT. I think it's important to point out that within the use for drug-coated balloons specifically, there are some real fundamental advantages to the use of paclitaxel as the drug compared to some of the other drugs. So I'm very comfortable with the position that we have for AGENT and excited about it as we laid out at Investor Day as a long-term growth driver for the company.
Operator, Operator
And the last question today will come from Pito Chickering with Deutsche Bank.
Pito Chickering, Analyst
A question about the proposed reimbursement for AF ablation and ASCs for next year. What proportion of AF ablations do you think could be moved into the ASCs? And how could the increased capacity using ASCs help fuel additional market growth?
Michael Mahoney, Chairman and Chief Executive Officer
Yes. I may need to consult with our IR team. Anecdotally, we are seeing strong interest in states without a certificate of need, particularly in Arizona and Florida, which we view positively due to the often lengthy backlog that hospitals experience with FARAPULSE. We believe this will help alleviate the backlog in these states over time. Many states cannot implement this due to CON requirements, but we anticipate an increasing trend in 2026, with further growth throughout the LRP period. Importantly, we are well-positioned to succeed in that market because of the reliability and trust that physicians have in FARAPULSE, as well as the favorable cost of goods sold and gross margin profile of that product, alongside the complementary offerings from Boston Scientific in our cardiovascular portfolio. An update confirms that we estimate 40% of AF ablations in the U.S. will not require a certificate of need.
Ken Stein, Chief Medical Officer
But maybe I'll just add something. But even in those states, it will take some time to build out the ASC capabilities, right? It's capital deployment. And there's not going to be a step change, like the step change that we saw with the adoption of concomitant, that this is going to be more of a slow ramp. But I think really important just to come back to what Mike said at the end, which is that the FARAPULSE and our entire ecosystem really is very well suited to enable these procedures to move out into the ASC.
Michael Mahoney, Chairman and Chief Executive Officer
Yes. So we think there'll be a minimal impact on ASC in '26. But I just think broadly on EP, we're still remarkably early in the PFA journey, given our launch, what, 18 months ago, Ken, or whatever, less than 2 years ago, I guess. And so the key for us is we continue to drive new account openings around the globe. We still have a lot of work to do with new account openings in the U.S. and particularly in Asia Pac. And the new account openings help drive penetration. We also have the opportunity to continue to grow deeper with more physicians leveraging FARAPULSE. We also have the opportunity with our unique position with concomitant to train more electrophysiologists to do WATCHMAN. So we still have a number of EPs out there that are not doing LAC procedures and with the impact of concomitant, we are seeing an uptick in the number of physicians who want to be trained in LAC. So that ecosystem of still early innings in PFA globally, the momentum of concomitant, the demand from physicians to learn and train on WATCHMAN now to serve that need will continue to help us, which is why the ASCs are important because we do need the ASCs over time to help with the volume demands that we're seeing across these markets.
Lauren Tengler, Vice President, Investor Relations
Thank you, Mike. Thanks 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 replay. Thank you, everyone.
Operator, Operator
Please note, a recording will be available in 1 hour by dialing either 1 (877) 344-7529 or 1 (412) 317-0088 using replay code 7215110 until October 29, 2025, at 11:59 p.m. Eastern Time. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.