Abbott Laboratories - Earnings Call - Q3 2025

Executive Summary

• Q3 2025 was solid: revenue $11.37B (+6.9% reported; +7.5% organic ex‑COVID) and adjusted EPS $1.30; EPS was in line with consensus and revenue was essentially in line, reflecting broad-based strength in Medical Devices and resilient EPD, offset by Diagnostics headwinds in China.
• Medical Devices drove the quarter with double‑digit growth across Diabetes Care, Electrophysiology, Rhythm Management, Heart Failure, and Structural Heart; FreeStyle Libre CGM sales reached $2.0B (+17.2% organic).
• Abbott reaffirmed FY25 organic sales guidance and narrowed FY25 adjusted EPS guidance to $5.12–$5.18 (double‑digit growth at midpoint), and declared a $0.59 quarterly dividend (407th consecutive).
• Key catalysts: structural heart approvals (TriClip in Japan; Navitor CE Mark expanded indication), EP PFA “Volt” ramp OUS with US expected next year, and CRM momentum from AVEIR leadless pacemakers; management signaled Diagnostics headwinds should lap by Q4 and ease in 2026.

What Went Well and What Went Wrong

What Went Well

• Devices-led growth: “sales grew 12.5% driven by double-digit growth in diabetes care, electrophysiology, cardiac rhythm management, heart failure and structural heart”.
• Libre strength: CGM sales $2.0B; management remains “very bullish on the basal segment…only ~20% penetrated in the U.S.” with additional sensor launches to drive penetration.
• Strategic approvals: TriClip approval in Japan and Navitor expanded CE Mark broaden treatment options and support share gains in TAVR/TEER; ESC guidelines upgraded TEER for mitral and tricuspid valves.
• Quote: “Recently launched new products generated nearly $500 million in sales this quarter and added more than 100 basis points to organic sales growth” – Robert Ford.

What Went Wrong

• Diagnostics headwinds: Global Diagnostics -7.8% organic; China VBP and DRG changes pressured core lab pricing and volumes; COVID testing declined to $69M from $265M YoY.
• Nutrition U.S. pediatric softness: share given back post competitor supply recovery; one large WIC contract loss impacted the quarter, though two new WIC wins start in Q1/Q2 2026.
• Tariffs compressed gross margin: adjusted gross margin 55.8% of sales in Q3 (down sequentially), with tariff burden first meaningfully felt in Q3; mitigation underway.

Transcript

Operator (participant)

Good morning and thank you for standing by. Welcome to Abbott Laboratories' third quarter 2025 earnings conference call. All participants will be able to listen only until the question and answer portion of this call. During the question and answer session, you will be able to ask your question by pressing the star one one keys on your touchtone phone. This call is being recorded by Abbott Laboratories. With the exception of any participant's questions asked during the question and answer session, the entire call, including the question and answer session, is material copyrighted by Abbott Laboratories. It cannot be recorded or rebroadcast without Abbott Laboratories' express written permission. I would now like to introduce Mr. Mike Comilla, Vice President, Investor Relations.

Mike Comilla (VP of Investor Relations)

Good morning and thank you for joining us. With me today are Robert Ford, Chairman and Chief Executive Officer, and Phil Boudreau, Executive Vice President, Finance and Chief Financial Officer. Robert and Phil will provide opening remarks. Following their comments, we'll take your questions. Before we get started, some statements made today may be forward-looking for purposes of the Private Securities Litigation Reform Act of 1995, including the expected financial results for 2025. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological, and other factors that may affect Abbott's operations are discussed in Item 1A, Risk Factors, to our annual report on Form 10-K for the year ended December 31st, 2024.

Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. On today's conference call, as in the past, non-GAAP financial measures will be used to help investors understand Abbott's ongoing business performance. These non-GAAP financial measures are reconciled with the comparable GAAP financial measures in our earnings news release and regulatory filings from today, which are available on our website at abbott.com. Note that Abbott has not provided the related GAAP financial measures on a forward-looking basis for the non-GAAP financial measures for which it is providing guidance because the company is unable to predict with reasonable certainty and without unreasonable effort the timing and impact of certain items, which could significantly impact Abbott's results in accordance with GAAP.

Unless otherwise noted, our commentary on sales growth refers to organic sales growth, which is defined in the press release issued earlier today. With that, I will now turn the call over to Robert.

Robert Ford (Chairman and CEO)

Thanks, Mike. Good morning, everyone, and thank you for joining us. Today, we reported organic sales growth of 7.5% excluding COVID test sales. Our growth was led by double-digit growth in medical devices, where several high-growth segments showed an acceleration in growth in the third quarter compared to growth in the first half of this year, and also high single-digit growth in Established Pharmaceuticals, led by double-digit growth in our key 15 markets. Earnings per share rose to $1.30, up high single digits compared to last year, and up double digits when excluding the impact of the expected large year-over-year decline in COVID test sales that occurred in the third quarter. Our performance continues to be driven by innovation, positioning Abbott Laboratories to consistently deliver high-quality results and durable long-term value to our shareholders.

Recently launched new products generated nearly half a billion dollars in sales this quarter and added more than 100 basis points to organic sales growth. Looking ahead, we expect increasing contributions from new products across the portfolio with a balanced mix of iterative and transformative innovation. I'll now summarize our third quarter results in more detail before turning the call over to Phil. I'll start with nutrition, where sales increased 4% in the quarter, led by adult nutrition business. Ensure remains the cornerstone of our adult nutrition portfolio, trusted by millions of consumers seeking to maintain or improve their health. Strong brand recognition, combined with favorable demographic and dietary trends, including an increased focus on protein intake and immune system health, continues to fuel our growth. Growth in adult nutrition was driven by 10% growth in international markets, where we continue to see strong demand for both Ensure and Glucerna.

To support future growth, we continue to invest in these well-known brands to ensure they evolve along with changing consumer preferences. We recently launched a new version of Glucerna that contains only 1 gram of sugar, and later this month, we'll launch a new version of Ensure that contains 42 grams of protein. Moving to diagnostics, we saw modest sales growth in the quarter excluding COVID testing sales. As expected, challenging market conditions in China, impacting both price and volume, remain a headwind for our core lab diagnostic business. Excluding China, core lab diagnostics grew 7%, with markets such as the U.S. showing an acceleration in growth in the third quarter compared to the growth in the first half of this year. Our strong, consistent performance outside of China reflects durable underlying demand in markets around the world.

Growth of 8% in point-of-care diagnostics was driven by growing adoption of two first-of-a-kind tests, our point-of-care concussion test and a high-sensitivity troponin test, which allows for earlier and more accurate detection of a heart attack. Turning to EPD, sales increased 7%, led by double-digit growth in our key 15 markets, highlighting broad-based demand and strong commercial execution. From a product portfolio perspective, several therapeutic areas delivered strong contributions, including gastroenterology, cardiometabolic, and pain management. These areas continue to benefit from favorable demographic trends and growing demand for high-quality, affordable medicines. We continue to make good progress as it pertains to our biosimilars strategy, a key growth pillar for EPD. During the quarter, we advanced the regulatory approval process for several biosimilars and remain on track with our planned cadence of product and geographic launches that began this year.

I'll wrap up with medical devices, where sales grew 12.5%, driven by double-digit growth in diabetes care, in electrophysiology, in cardiac rhythm management, in heart failure, and in structural heart. In diabetes care, sales of continuous glucose monitors were $2 billion in the quarter and grew 17%. In electrophysiology, sales grew double digits in the U.S. and internationally. The launch of our new Volt PFA catheter in Europe continues to go very well and help deliver double-digit growth in ablation catheters in international markets this quarter. Feedback from European physicians who have used Volt continues to be very positive, and we look forward to bringing Volt to the U.S. market next year. In structural heart, growth of 11% was led by share gains in TAVR and growing adoption of Triclip. During the quarter, we achieved important milestones in our structural heart business.

In July, we received regulatory approval for Triclip in Japan. Triclip is the first and only minimally invasive treatment option available to patients in Japan to treat tricuspid regurgitation. In August, we received CE mark for an expanded indication for our TAVR valve, NAVTOR, to treat people who are at low or intermediate risk for open heart surgery. This expanded indication was supported by data from our Vantage study, which was presented as a late breaker at the European Society of Cardiology Congress. In cardiac rhythm management, growth of 13% was led by strong uptake of our Aveir leadless pacemaker, which is expanding the market and capturing share in both the single and dual chamber pacing segments.

Our vision for Aveir was to help change the standard of care for cardiac pacing, and that vision is now becoming a reality with our cardiac rhythm management business outperforming the market for 10 consecutive quarters and driving an acceleration in growth from high single digits last year to double digits this quarter. In heart failure, growth of 12% was driven by growth across our portfolio of ventricular assist devices and growth of CardioMEMS, our implantable sensor used for the early detection of heart failure. In vascular, growth of 5% was led by continued strong performance in our market-leading portfolio of vessel closure products and increasing contributions from ESPRI, our below-the-knee resorbable stent. In August, we received CE mark for ESPRI, and we look forward to offering this innovative technology to people outside the United States who suffer from peripheral artery disease.

Lastly, in neuromodulation, growth of 7% was led by strong performance of our Eterna rechargeable spinal cord stimulation device in international markets, reflecting both continued uptake in existing markets and launches in new markets. In summary, we delivered another very good quarter. Our pipeline has been highly productive and continues to fuel growth, and we remain on track to deliver high single-digit organic sales growth and double-digit EPS growth. I'll now turn over the call to Phil.

Phil Boudreau (EVP, Finance and CFO)

Thanks, Robert. As Mike mentioned earlier, please note that all references to sales growth rates, unless otherwise noted, are on an organic basis. Turning to our third quarter results, sales increased 5.5% or 7.5% when excluding COVID testing-related sales. Adjusted earnings per share of $1.30 was in line with the consensus estimate. Foreign exchange had a favorable year-over-year impact of 1.4% on third quarter sales, which was less favorable than what we forecasted at the time of our earnings call in July. Regarding other aspects of the P&L, the adjusted gross margin profile was 55.8% of sales, which, as expected, reflects a decrease compared to the prior year due to the impact of tariffs. Adjusted R&D was 6.4% of sales, and adjusted SG&A was 26.4% of sales. Adjusted operating margin was 23% of sales, which reflects an increase of 40 basis points compared to the prior year.

Based on current rates, we expect exchange to have a favorable impact of approximately 1.5% on our fourth quarter reported sales. With that, we'll now open the call for questions.

Operator (participant)

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star one one on your telephone. You will then hear an automated message advising you that your hand is raised. To withdraw your question, please press star one one again. For optimal sound quality, we kindly ask that you please use your handset instead of your speakerphone when asking your question. That's star one one to ask a question. Please stand by while we compile our Q&A roster. Our first question will come from Larry Biegelsen from Wells Fargo. Your line is open.

Larry Biegelsen (Senior Analyst)

Good morning and congrats on the quarter, and thanks for taking the question. Robert, back in July, you sounded comfortable with consensus sales and EPS for 2026. I'd love to hear your high-level thoughts on next year. If you're still comfortable with consensus, it seems like you have some nice tailwinds next year. Thanks for taking the question.

Robert Ford (Chairman and CEO)

Yeah, Larry. Yeah, I'm very comfortable with consensus. In fact, you know this is a question that was asked last year in our Q3 earnings call, and consensus for 2025 at that time was 7.5%, EPS growth of 10%. That's the same consensus estimates that we have today. I was comfortable with delivering that type of growth at this time last year, and I'm comfortable again today forecasting to deliver that type of growth next year. These estimates that you referenced, they're pretty much in line with the results that we've delivered year to date. We delivered those results in a year where we faced, I'd say, larger than expected headwinds in diagnostics and unexpected impact here from tariff. I think that's just a great example of the culture we have here at Abbott Laboratories. It's just no excuses, just adapt and deliver.

The portfolio that we have, we have the ability to do that. When I think about our ability to sustain this level of performance that we're seeing in 2025 into 2026, I really see it as kind of three key buckets of growth for us, Larry. First of all, there's underlying momentum in the current portfolio, whether it's in medtech and in Established Pharmaceuticals and a large portion of our diagnostics business. I expect that momentum to continue. We've got high-growth products here, whether it's Aveir, TAVR, Libre, Triclip. I'm sure we'll talk about those. That's one big driver of our growth sustaining into next year. The second one, I'd say, is new product launches. We've got a lot of new product launch cadence into next year, whether it's Volt in the U.S., PactaFlex Duo, our dual analyte sensor, the new Alinity N diagnostic system, biosimilars.

I mean, these are all product launches here that will add to our sales and sales growth. That will gain momentum over the course of the year. As I said, also we've got, I'd say, some easing of some of the headwinds that we had this year, pretty significant headwind in diagnostics. We talked about that, I guess, in July, over $1 billion of headwind, whether it's the VBP pricing dynamics in China this year or the decline in COVID testing. I think we'll start to see a full lapping of that next year on a full-year basis, but we'll start to see some of it, quite frankly, in Q4. I feel very confident and comfortable with that type of top-line growth. If you look also why we're in this position, Larry, I mean, we made investments in 2020, 2021.

You know, these product launches that I'm highlighting here, those are investments that we made. We'll be able to deliver the high single-digit top-line growth, double-digit EPS growth, while at the same time, I'm going to remain unwavering here in the commitment to invest in the pipeline and drive growth organically. We'll have close to 200 clinical trials across all of our businesses across a variety of different geographies next year. Within those, we're going to initiate some really important pivotal trials next year that we're funding for products that we expect are going to be significant contributors in the future, whether it's the mitral valve replacement clinical trial that will go into IDE, our balloon TAVR trial will go into IDE, Aveir conduction system pacing, a peripheral IVL IDE trial, a continuous lactate monitor sensor IDE trial.

We can maintain this top and bottom line growth while at the same time making the investments in the portfolio that we know we need to do. We've got a good track record here expanding our gross margins and our op margins. We've got great gross margin improvement teams. We've been able to work hard this year to be able to mitigate the impacts of tariffs as they have a full-year effect next year. We feel good about being able to drive the top and the bottom line. The portfolio has been pretty resilient over these years. It's got nice offensive and some defensive kind of characteristics. Overall, I feel very good about the momentum we have going into the momentum that we have in the second half of this year, carrying into next year, and just feel good about the outlook that we've got for next year. Yeah.

Larry Biegelsen (Senior Analyst)

Perfect. Thanks for taking the question.

Operator (participant)

Thank you. Our next question will come from Robbie Marcus from JPMorgan. Your line is open.

Robbie Marcus (Managing Director and Senior Analyst)

Oh, great. Good morning. Thanks for taking the questions. Robert, two quick ones from me, one on diabetes, one on EP. Maybe first on diabetes, such an important growth driver to Abbott. Beat overall, driven by outside the U.S. with a slight miss in the U.S. Given the investor focus there, I was hoping you could give a little more color on what's happening in the U.S. and outside the U.S. and how you're thinking about the market developing, particularly in the U.S. with the ketone sensor on its way, hopefully next year, and what seems like increasing commentary on CMS coverage of non-intensive type 2.

Robert Ford (Chairman and CEO)

Sure, Robbie. Yeah, U.S. grew 19%. We did not really have any kind of comps on that. Year to date, the U.S. is up 25%. I think growth, I think what you are referring to a little bit there is growth in the first half of the year was a little bit higher, really, due to some shelf restocking dynamics that we saw. If you remember last year, Robbie, we launched FreeStyle Libre 3 and had a pretty significant drive in demand here, higher than what we had anticipated. The new manufacturing facility we made the investment in was not fully up and running. That caused back orders with customers. It caused back orders with the wholesalers at the pharmacy channel. The way we had planned this year was our manufacturing site would come up and running, and it would be more of a linear kind of recovery.

The factory actually did really well in the first half. That led to customers doing some restocking earlier than what we had thought and a little bit higher, quite frankly, just given the demand that they were seeing in FreeStyle Libre 3. That resulted in a little bit of a pull forward of a couple percentage points of growth. I think it is just a little bit of a timing dynamic. Most importantly, we remain on track with the original U.S. full-year growth assumption of over 20%. Demand is still very, very strong, and we are seeing that. To your question on kind of next year, yeah, I expect to see another real strong year of growth in the U.S. with additional demand coming from the new sensor, the new dual analyte sensor. I think that is going to help drive increasing penetration in that intensive insulin user segment.

I would say there is still room for penetration internationally, I would say, in that segment. In the U.S., there is still some room also, but I would say that is going to really help us drive share gains, whether it is in the pumper segment or just in general intensive insulin user segments. There is still a lot of penetration in the basal segment. I mean, I know because of the dual analyte sensor, we get a lot of attention on this intensive insulin segment, but I am still very bullish on the basal segment. In the U.S., it is only about 20% penetrated today. Internationally, it is only 5%. It is less than 5%. I think there is still a lot of opportunity for growth in the U.S. with continued basal penetration, not to mention the potential for CMS to cover type 2 non-insulin.

I think that is an opportunity. I see positive signs of that developing. The ADA has been very supportive of that. I think you could probably see proposed coverage of that come out sometime next year, maybe in the first half. You have your normal timing there of comment periods, the final cover decision, when the actual date's going to be. I think there's a scenario where that could happen next year, and we'll be ready to execute. I'm not building that assumption of that segment coming in or having any significant contributions in 2026. It's not in my base forecast for 2026. If it becomes a reality, I think this will be a real nice win for CMS patients. I think we've got a lot of growth opportunities between the patient segments, between the technology being launched across geographies.

I know your question was focusing a lot on the U.S. I think we've got a great portfolio and a great lineup as we go into the U.S. next year. I also think there's just tremendous opportunity internationally. That's an area of particular strength for us, that we built the scale, that we built the technology, and the cost positions there. I feel good about FreeStyle Libre. I feel good about our U.S. position and the momentum that we're going to have U.S. and internationally.

Robbie Marcus (Managing Director and Senior Analyst)

I appreciate that. You talked about new product launches. Volt was one that you highlighted. We're expecting that, I believe, around mid-year next year in the U.S. Maybe speak to Volt, the early feedback in Europe that you've received, and how people should think about the ramp and cadence of Volt and overall electrophysiology as we move into next year. Thanks a lot.

Robert Ford (Chairman and CEO)

Sure. We're seeing an acceleration in our growth rate in electrophysiology, obviously, in the second half. We knew that was going to be the case. The second half was going to be better than the first half, and 2026 will be better than 2025. I think that you've seen here double-digit growth across the board, more specifically also in our ablation catheter portfolio. I feel good about what we've done here, Robbie. This idea that we've been playing defense over the last couple of years, it's actually been a quiet offensive strategy where we've used the adoption of pulsed field ablation on other competitive systems to increase our capital footprint. Now we'll be in a position to bring in the catheter, the PFA catheter. It's doing very well. I just got some feedback yesterday and have been following the rollout. It's going very well.

I'd say efficacy and efficiency, those seem to be table stakes right now. Pulsed field ablation has proven to work and get the job done more quickly. I think what I'm seeing now is longer-term durability of results, safety. These are becoming quickly, I think, the points of competitive differentiation. I think Volt is going to offer a couple of areas there. I'm not the expert in all this, but what I've heard so far has been that two advantages that come across loud and clear for Volt is it delivers energy in a very kind of focused direction. The lesions are broader, they're deeper, seem to be more durable, and minimize the risk of hemolysis. The second thing I continue to hear resounding positive feedback is the integration with N-Site is a game changer, right?

That real-time contact visualization that we always talked about, we thought that that was going to be an important differentiation. We're seeing that it reduces because you've got that real-time. We're seeing that it's reducing the amount of applications, and as a result of that, minimizing muscle contraction. That minimization of muscle contraction allows us to then run these procedures with conscious sedation rather than exclusively with general anesthesia. I think that's a hugely important aspect if you look at what's going on with healthcare systems and the difficulties with general anesthesia and having that specialty ready to go at any given time. That gives us flexibility in a lot of European markets and in a lot of segments here in the U.S. We'll continue to roll it out internationally. I think your timing for Volt is an okay timing for now.

I mean, obviously, we're going to try and target to see an earlier approval. For now, I think that's not a bad timing to have. I think what's been clear for me over these last couple of years is just the importance of the full portfolio. I think that Abbott's shown that it does have a full portfolio, not just of the mapping, the capital, the talent, and the clinical specialists that are out in the field, but also bringing in a wide variety of different PFA tools, whether it's a one-shot, whether it's going to be a focal PFA through our PactaFlex that we expect to get approval in Europe next year. Quite frankly, it's been increasingly clear to me that the companies are going to need more than just PFA. You're going to need to have PFA, and you're going to need to have LAA.

We've got both of those. I don't think it's a question of Abbott being late. We're right on time, and we're complete with the full portfolio that we need. I expect EP to do much better in 2026 than what it did this year. I think this year has done pretty well, too.

Robbie Marcus (Managing Director and Senior Analyst)

Appreciate all the insights. Thanks, Robert.

Operator (participant)

Thank you. Our next question comes from David Roman from Goldman Sachs. Your line is open.

David Roman (Managing Director)

Thank you. Good morning. I wanted to switch gears a little bit onto the diagnostics business. Clearly, a lot of focus this year on some of the discrete headwinds that you faced around China VBP and DRG updates, the dynamics with U.S. aid and COVID testing. I think you made clear in your comments around 2026 an expectation that those headwinds start to moderate. Could you maybe talk a little bit more about some of the underlying drivers of the business and how you think about an overall acceleration in the diagnostics business going forward?

Robert Ford (Chairman and CEO)

Sure. I don't think the dynamics that we've been talking about, David, have changed. I don't think that's a bad thing, to be quite honest with you, because it just shows that I think we've got a handle on kind of the headwind that we've been facing, which was really the VBP in the diagnostics area. I think one of the things I talked about, different from other VBPs that we've seen in China, is that usually, if you want a VBP kind of tender, you have a price hit, but then you've got a volume kind of offset. I think you just raised there one of the challenges we've seen in this segment specifically is you had the price hit, which was the majority of our headwind, but you also saw some changes in the DRG model that has impacted volume a little bit also.

I was actually in China last week. I spent the week there. I was over there over the weekend, too. I had an opportunity to really go in depth with all the different stakeholders. I think the team has done a really good job at navigating this. I think that if you look at some of the dynamics that we're seeing in some of the accounts, we're starting to see a little bit now of some of that volume start to repick up. I'm not going to say that it's fully back, but I'm encouraged to see some of the signs start to pick up in terms of volume there. If you look at how that happens, it really started happening in Q4 of last year. We'll start to see a little bit of that headwind, kind of that comp start to be minimized in Q4 this year in China.

Next year, you know, like I said, we've made changes. We've brought in new products, new management teams, etc. I feel good about what I saw there last week, David. I don't think that that's changing. Like I said, I think that's not a bad thing. We'll be lapping all of that, and we're seeing nice progress there from the team, too. I do think that the aspect that is changing is we are seeing our business outside of China continue to accelerate. That's going to be the other dynamic here to be able to move our diagnostics business from being kind of low single-digit growth to now kind of mid-single-digit, mid-to-high single-digit growth next year. U.S. has done incredibly well. I'll give a lot of kudos to the team there. They were up 10% this quarter, and that's driven by a lot of new business capture.

Again, the portfolio is very competitive. We got a large number of new business that we acquired last year and continue to see new business converting to Abbott this year. I think share gains in the U.S. is really what's driving that. European region did very well, too, this quarter. I think they were up 6% to 7%, and they're doing very well also. Latin America for us is growing mid-teens, consistently growing mid-teens here also. I think the dynamic is not changing. We're not seeing the situation get worse in China. I think the teams are doing really well there, and we'll be out of that next year. Outside of China, I think the dynamics are going exactly how we've expected them to go, which is Alinity is being rolled out. It's a very competitive system. The teams are hitting their stride here in various important geographies.

Like I said, I expect that to continue. You put that combination together, David, of passing the headwinds of the VBP in China and continued acceleration in all the other geographies. I think diagnostics is set up for a nice recovery year next year.

David Roman (Managing Director)

Very helpful. Maybe just one follow-up here on the P&L. I think in the gross margin line, there are probably a lot of moving parts this quarter around the first quarter burdening the impact of tariffs and then also probably some foreign exchange-related dynamics on a significant move in the euro, for example. Can you maybe help just decompose a little bit through the operational performance in the P&L from some of those other factors and how we should think about margin trajectory on a go-forward basis?

Robert Ford (Chairman and CEO)

Yeah, I'll ask Phil to take that one, Phil.

Phil Boudreau (EVP, Finance and CFO)

Yeah, thanks, David. I think you touched on the right elements there. Gross margin continues to be a key area of focus for us. We've spoken in the past to the dedicated teams that we have in each of our businesses that drive the constant ideation and execution throughout our supply chains and operations, even our affiliates. That's progress that we continue to make good traction on here. The step back that you referred to here in Q3 sequentially certainly reflects a normal pattern that we have more of our plant operational maintenance shutdowns that occur in the third quarter. That's a normal sort of phenomenon. Also, as you touched on, the first meaningful impact of tariffs that we're feeling in gross margin is in the third quarter there as well.

I would say we've done a really nice job in terms of the team that I chartered to work on tariff mitigation. We continue to make good progress there and implement ideation not only on how to improve that impact going forward, but also the teams generating ideas to pass over to the gross margin expansion teams and continue to feed that funnel. I think we are kind of on track with year-to-date 60 basis points of gross margin expansion and comfortable that that pattern will continue here and kind of maintain that sort of 57% outlook in the profile going forward.

David Roman (Managing Director)

Thank you very much.

Operator (participant)

Thank you. Our next question will come from Josh Jennings from TD Cowen. Your line is open.

Josh Jennings (Senior Research Analyst)

Hi, good morning. Thanks for taking the question. I wanted to circle back on the EP franchise and the outperformance in 3Q. Sorry to get a little bit granular, Robert, but I was hoping you could just help us better understand the drivers of the double-digit ablation catheter growth. One, and then sorry for a three-part question, but hopefully they'll be pretty easy to digest. Second is just, you know, I think the consensus view is that Abbott's mapping franchise has been driving the double-digit growth this year to date. Maybe just help us understand as the competitive environment and mapping evolves, you know, how you see the mapping franchise performance in 2026. And then just lastly, in the third part, you know, where do you, where does Abbott's CPFA penetration in the U.S. and OUS, by the time Volt's launched globally?

I guess in 2026, do you think we could be north of 80% in the U.S. and a little bit lower than that OUS? Thanks for taking the questions.

Robert Ford (Chairman and CEO)

Sure. Let me see if I can kind of go through all of them here on this. I think your first question was just what's driving the ablation, the double-digit ablation growth. That's significantly driven by international, as you probably would have expected, Josh. A big driver there has been that. You know, we've got good growth, good mapping growth, in the United States still. We still believe that we're, the data shows that we're still market leader in mapping cases. Obviously, with other competitors launching their mapping systems, we've seen an uptake in their mapping, in the amount of cases that they're now mapping, tied to their own catheters. Even with that, we still feel that we've got a leadership position in the amount of PFA cases that we've mapped. We have added other products also that help drive our growth there.

This goes back to this understanding of all the different segments in the EP area. You know, yes, ablation catheters are important. They're a big segment of the market, and so are diagnostics. We've got other parts of the portfolio also that are driving growth. We recently launched our 13 French Agilisheath, which is viewed as one of the best introducer sheaths for not only our product, but even for competitive systems also. That helps also. We're launching ICE also. That's also a driver. I think, again, going back to my comment, you got to have a full portfolio here. I think, you know, trying to pin it down to like, is it mapping? Is it this?

Yeah, I mean, obviously, we're tracking all those different segments, Josh, but we kind of view it as looking at the amount of cases that we're doing and looking at it on a revenue per case. Our revenue per case is actually going up as we're introducing more and more new products to support those cases. I think your last question was about penetration of PFA. It seemed like it is becoming the go-to energy source here. I think the numbers that you threw out there sound reasonable. If you think about 2026, you'll now have all four manufacturers with PFA ablation catheters, with mapping systems tied to PFA ablation catheters. I think that number sounds reasonable to me. Internationally, yeah, it's a little bit less, but we'll see. We'll see what will happen.

I think that Volt could actually change that dynamic internationally, and maybe it can lead to a much higher penetration rate in international markets, specifically in Europe, that mimics the U.S. penetration. That's not a bad assumption to have for now.

Josh Jennings (Senior Research Analyst)

Appreciate it. Thanks, Robert.

Operator (participant)

Thank you. Our next question will come from Vijay Kumar from Evercore ISI. Your line is open.

Vijay Kumar (Senior Managing Director and Equity Research Analyst)

Hi, Robert. Good morning. Thank you for taking my question. I had one on, maybe high level on China, right? I know there is, you know, outside of VBP, I think some macro issues are challenging volumes, right? When you look at overall China, inclusive of diagnostics and medtech and EPD franchise, can you just remind us what China has done for you year to date? What was it last year? What is your view on normalized growth outlook for China? I think one of your peers just said that they expect a mid-teens organic growth outlook for China. I'm curious to hear your view on China.

Robert Ford (Chairman and CEO)

Yeah, sure. Listen, I was there last week. Like I said, it's an important market for us, and it's going to continue to be an important market. As the company has grown in portfolio and its participation in our total revenue as a percent of total revenue has come down a little bit, right? If you look at China, let's say 10 years ago, Vijay, it was probably close to like 9%, 10% of total Abbott Laboratories revenue. Today, it's less than 6%. It doesn't mean that it's not an attractive area of the world for us to continue to invest in and drive to.

If you look at our EPD and nutrition businesses, those two businesses have been up double digits year to date, and the team has done a really good job there building the portfolio and taking advantage of the growing segments there that we can offer innovation and solutions. Our cardio, neuro business has actually seen sequential growth step up throughout this year. I think if you take out the real challenge for us, it has been, obviously, the diagnostics piece. That was one of our larger businesses in China before the VBP. Q3 decline was pretty much in line with what we saw in Q1 and Q2. If you remove that, I'd say our growth rate in China is around 5% to 7% if you take out the diagnostics piece. I think that that's probably not a bad place to be in.

As we expand the portfolio there, bring in new innovations, I think that that's probably a good growth target that I look at for 2026. I don't know who you're referring to who's talking about mid-teens. If it's a company that doesn't have a lot of business, then, yeah, then you've got opportunities to grow your position. We've got a lot of business in China, and I think that a growth rate of mid-single digits, at least how we're planning for, is how we built how we're looking at our 2026. Quite frankly, as we look kind of going forward, I'm placing a lot more emphasis on growth contributions from other geographies. I think we've got a lot more opportunities than over here. Again, like I said, it still remains an important market for us, and we're committed to it.

Vijay Kumar (Senior Managing Director and Equity Research Analyst)

That's helpful. Maybe one quick one on your, I think cardiac rhythm management is now your fastest growing product line within medtech. That's kind of crazy when you think about diabetes and all the other good things that's happening. Can you remind us on how big is this category, the dual chamber leadless pacemaker, and where are we from a penetration standpoint? What innings are we in?

Robert Ford (Chairman and CEO)

Yeah. I'm going to pick up on its kind of crazy comment that you made. For us, it's actually taking a vision that we had, like I said in my opening comments, to change the standard of care here, make the investment that's been done. I think now we're seeing the benefit. It's fundamentally changed the growth trajectory of our business. I'd say five years ago, our cardiac rhythm management business was flat. Then it moved to a mid-single digit, high single digit, and then this quarter hitting double digits. It's pretty remarkable also, I would say, given the fact that this has historically been a low-growth market. We're obviously taking market share. I give total kudos to the team in terms of how they went about this, all the way from R&D, operations, clinical, commercial. I think they've done a really good job.

I think Aveir is just now really hitting its stride, and we're driving uptake in both single and dual chamber. I expect this to continue. I expect this type of performance to continue for the next few years. They've established a very large base of U.S. physicians that are now implanting this. I'd say on a single chamber, we're probably about 50% penetrated, so there's still room to grow there. Half of our implants so far have been dual chamber, and we're probably sub 10% penetration over there. Those penetration rates are mostly U.S. I think there's a lot of opportunity here for us to do this and to live up to that vision. We've got great opportunity international, too. We're seeing really nice momentum in Europe and Japan. I think the long-term aspiration here is to be able to convert a significant portion of this market.

We estimate the low-voltage pacing market to be around $4 billion. We want to convert a significant portion of that and, in doing so, become the market leader in this segment. The team's done a really good job. There's pipeline, there's innovation, there's clinical work, there's investment behind it. It's not crazy to think about it if you look at all the work that the team has done and put forward. I think they're ready to capitalize on this, and they have pretty high aspirations of where they want to take their sales and their market position.

Vijay Kumar (Senior Managing Director and Equity Research Analyst)

That's very helpful. Thank you.

Operator (participant)

Thank you. Our next question will come from Danielle Antalffy from UBS Investment Bank. Your line is open.

Danielle Antalffy (Senior Analyst)

Hey, good morning, guys. Thanks so much for taking the question. Robert, I wanted to touch on two questions, one on diabetes, one on structural heart. I just wanted to touch on the structural heart piece of the business. Specifically in left atrial appendage closure and how you guys are thinking about that, it has been a high-growth market. It feels like you guys might not really be benefiting yet from the concomitant procedure. Maybe you could talk a little bit about how you see left atrial appendage closure evolving for Abbott specifically in 2026 and beyond. Just one quick follow-up on diabetes. Thanks so much.

Robert Ford (Chairman and CEO)

Yeah, sure. I think it's a really important area of growth. You're right. I don't think that we've taken the right amount of share with a concomitant procedure. I know that the teams are looking at how to do that more effectively as we go into the beginning of next year. This is an area that we continue to invest in. I think that what I'm seeing right now from the results, or at least feedback that I've heard from physicians on our next generation amyloid device, is significantly positive versus what I've heard from other products that we've put into trial. When I get calls and texts and things like that from some of the KOLs that are working on the trial, really making sure that we understand how competitive and how good this next generation is, I think that's going to allow us to do that.

We've actually completed the enrollment of that trial. We're going to be filing, we have to do the follow-up, and then we'll be filing in the first half of next year. We'll see if this is a 2026 launch or if it's more of a 2027 launch. I think that's going to be hugely important, and I think it's going to be hugely important as it relates to our full portfolio here. We think that it's going to be a differentiator for us to be able to have not only all the PFA tools and mapping tools and service and support, but now to be able to add a much more competitive device on the LAA side. We've got a readout of our trial against NOAC. That'll be in 2027. I understand that there'll be a readout from a competitive system next year.

I think that this is a high-growth area and one that's got a lot of attention from me and from the management of our device teams on how we can kind of leverage the portfolio better. I've got high expectations as we go into next year, and especially with the next generation product.

Danielle Antalffy (Senior Analyst)

Gotcha. Just the quick question on diabetes. You know, we've talked in the past about CGM becoming standard of care. I'll be very honest, it surprises me that we're still only 20% penetrated in the U.S. and basal. What do you think are still the barriers to this? How long will they persist? You talk to clinicians, and it feels like the momentum is there. Quite frankly, we should be inflecting at this point. I just can't tell if we are. I'm just curious what you think is maybe preventing that, or maybe you think we're in the inflection. I don't know. I don't want to speak for you, but just if you could comment on that.

Robert Ford (Chairman and CEO)

Yeah. I think it's difficult to generalize. Every market that we've seen on the basal has gone at different speeds. If I look at some of the key European markets where we got full basal, it's actually gone, I would say, maybe at three-quarters of the speed that the intensive insulin user kind of got picked up. You're right, the U.S. is a little bit slower. I think there is a large universe of primary care docs that needs to be covered. There's probably more awareness that needs to be built. I know you might think, there's just already a lot of awareness. How come it's not ascended? There's still a lot of pockets around this country where we're going in with our sales force for the first time. There's a very high-level understanding of what CGM is, but there hasn't been a lot of experience.

That's what we're working on. A lot of sampling programs. I think the work that we did, that the team did for Epic integration in a more turnkey versus every different office doing their own integration. To have it fully integrated into Epic, I think that'll be good. I think the other thing that is going to be important for the primary care doc, I mean, these are very fast visits, Danielle. They don't have a lot of time. I think they're starting to really understand the benefit of using ambulatory glucose profiles and look at those and be able to find out where the problem is in that basal population. It's 20%. There are probably pockets of the United States where I've seen higher penetration rates, but that's okay. I think that what's important for us is that we're continuing to see an increased sustained penetration.

If I were to sum it up, it's probably more dependent on us than it is about concerns about whether there's value or not value. I think the clinical data is pretty resound in terms of the benefits that it has. This for me is just more about us doing better, investing more, covering more physicians. That's what we're doing.

Danielle Antalffy (Senior Analyst)

Great, thank you.

Operator (participant)

Thank you. Our next question will come from Joanne Wuensch from Citi. Your line is now open.

Joanne Wuensch (Managing Director and Senior Equity Analyst)

Thank you. Good morning. Two quick questions on nutrition. I'll put them both up front. Could you give us an update, please, on where we're sitting on the NEC litigation? It looks like there were some pockets of nutrition that were weaker this quarter than we would have expected. If you could just sort of address that and how you think about that going forward, that would be great. Thank you.

Robert Ford (Chairman and CEO)

Yeah, sure. On the litigation, as I've done in the past, I'm not going to comment on any deep into any specific cases. I think you saw, over the last couple of months, you saw some of the federal cases go through the process. In both those cases, Abbott won on summary judgment. I stand behind the products. I stand behind our label and the importance of these products in the healthcare system. We'll see more cases progress this year and into next year. There's clearly a difference in terms of how the federal cases are being looked at versus maybe some of those earlier cases on the state are being looked at. We remain committed and we'll commit to defending the product and defending the use of it going forward. I think your other comment was pockets of softness in nutrition.

I'd say for me, if you look at the 4% growth, it's pretty much in line with our kind of historical growth rate. I think the one that was a little bit off, where we historically had been, was in our U.S. pediatric. That's just a competitive impact. We gave back some share that we had captured last year when a competitor experienced a supply disruption. I knew it was going to be difficult to hold on to it permanently. I'm disappointed that we saw that happen. On top of that, we also saw a large WIC contract, state contract, move from Abbott to a competitor in the quarter. That had an impact over there. I expect some of these share losses here that we've seen in the U.S. to impact our growth rate here in the U.S. pediatric for the next couple of quarters.

We faced this during the supply disruption in 2022, and we got our share back. It takes a few quarters, but I'm very confident that the team will be able to do that. First, because we recently won two new WIC contracts. The combination of those two contracts actually are higher than the one that we lost, but those go into effect Q1 and Q2 of next year. We've got several new product launches that we'll be launching here in the U.S. over the next couple of quarters. It's going to take a couple of quarters, but I'm confident we'll be able to get our share back.

Joanne Wuensch (Managing Director and Senior Equity Analyst)

Thank you.

Operator (participant)

Thank you. Our next question comes from Travis Steed from BofA Securities. Your line is open.

Travis Steed (Managing Director and Equity Research of Medical Technology)

Hey, thanks for the question. I guess kind of big picture, I wanted to talk about the sustainability of the device business. You've had kind of 10-plus quarters of double-digit growth. Just trying to think about the sustainability of that going forward. When you think about kind of the procedures and underlying procedure market, growth in the pipeline that you guys have, just want to think about your view there, kind of longer term.

Robert Ford (Chairman and CEO)

Yeah. I think the way our device portfolio has evolved, if you look back five, six years ago, it was a high single-digit grower. The combination was really, you had double-digit growth in diabetes and EP and structural heart. Then you had, I'd say, about 40% of our revenue in vascular and CRM that was relatively flat. The way we've done this, and I've talked about this also, is, okay, how do we ensure that the high-growth areas continue to grow and accelerate? That's what we're seeing in structural heart and EP and diabetes, even in heart failure. Then how do we reposition what we would characterize as historically slower growth segments of a very large portion of our portfolio? How do we get them from being flat to at least growing mid-single digits? If you get them to grow mid-single digits, then you move up to double digits.

That's what essentially has happened. If you look at our CRM business, I talked about this. It's gone from being flat to now being double-digit. That has a tremendous impact. I think that there's a lot of sustainability in that. In our vascular business, we've started to reposition the portfolio. I would say vascular is on the same journey that CRM was on. Maybe a year or so behind it, but we're already seeing the impact. We've been able to show pretty consistent delivery of 5%-6% growth in our vascular business over the last year or so. I think they're on their kind of journey to reposition the portfolio to higher growth. My expectation is that it is very sustainable. We're in these very high-growth markets. We have great portfolios. We've been investing significantly and disproportionately in those programs from product development to clinical trials.

I think it's very sustainable.

Travis Steed (Managing Director and Equity Research of Medical Technology)

Great. I wanted to follow up on the balance sheet and M&A, kind of a lot of cash in the balance sheet. How are you thinking about the portfolio over the medium term? Do you have the right assets going forward? New markets you want to be in. At some point, are we going to see you guys utilize the balance sheet and the cash?

Robert Ford (Chairman and CEO)

Yeah, we have been using it. We have been using it in terms of dividend and growing our dividend. We have been using it in terms of share buybacks. We've been using it in terms of debt and debt paydown. We've got $3 billion of debt to pay down next year. I think I'd prefer to pay that down when it comes due, but we'll wait to see what interest rates look like. We have been using it. We've been making investments, internal investments with manufacturing and some of our digital solutions. Yeah, I don't think that we've just been sitting on it. Obviously, we've got businesses that are very strong, positive cash flow generators. On the M&A side, like I talked about, there being opportunities, very good opportunities out there.

We've got a strong organic pipeline, which allows us to be a little bit more selective, but there are opportunities that fit us strategically, and there are a lot of opportunities that fit us strategically and can generate an attractive return. We've got capacity to do that, too. I like the position we're in, but we are putting our cash to use.

Travis Steed (Managing Director and Equity Research of Medical Technology)

Great. Thanks a lot.

Robert Ford (Chairman and CEO)

Yeah.

Operator, we'll take one more question, please.

Operator (participant)

Thank you. Our last question will come from Suraj Kalia from Oppenheimer & Co. Your line is open.

Suraj Kalia (Managing Director and Senior Analyst of Medical Technology and Devices)

Thank you for taking my questions. Robert, structural heart continues to be an important segment for Abbott Laboratories. You talked about some of the new products on the horizon, balloon expandable valves, SEPIA, and so on. I would love to get your thoughts specifically on the mitral and tricuspid U.S. TAM. The landscape seems to be changing with SGLT2 inhibitors, cath lab capacity, and so on. What are the puts and takes for realizing this TAM? Thank you for taking my questions.

Robert Ford (Chairman and CEO)

I mean, I think there's a lot of opportunity in those two products that you just referred to. I think on the tricuspid side, what needs to be done here is continue to invest in data and data generation to be able to strengthen the referral pathways, to be able to have broader adoption. I think between repair and replace, it's good to have both those tools. Right now, what I'm seeing is repair is being the preference, just given the safety profile. On the MitraClip side, we've invested in a clinical trial to look at using MitraClip in low and intermediate risk patients. I think for those two products, you're going to have to continue to invest in clinical and clinical evidence. Obviously, you support that with your field-based teams, etc. I think the real big drivers of and continued drivers of that are going to be clinical evidence.

I take a step back here and maybe just look at how you started your question about structural heart. You went quickly into those two products. This is an area that, in my view, if you want to be a cardiovascular medtech leader, you have to have a strong, robust and differentiated portfolio and strong position in structural heart. If you look at the revenue across the players, last year, I think we crossed over to number two. We have a number two position, and I don't think that's by accident. We've invested in that area. We've invested heavily in that area. We've got a portfolio of great products.

You have MitraClip, Triclip, but you've got NAVTOR, you've got Amulet, and you've got several, if I look at over the next couple of years, there are multiple catalysts here to sustain and even accelerate this double-digit growth that we got, whether it's label expansions in NAVTOR, MitraClip. We launched our fifth-generation MitraClip and Triclip product. That's important. We've seen guideline changes happen. You saw some of that guideline change happen in the European conference about a month ago, expanding the product and the technologies to other markets. I think the launch of Triclip in Japan is going to be a real important move for us. We've done some bolt-on M&A in this space also. This quarter, we actually bought an AI-powered imaging software company in Europe that specializes in individual cardio pre-procedure planning. I think that's going to be hugely important in this space.

We've added to that and, you know, integrating that team into our programs. The pipeline, like you said, whether it's balloon TAVR, Amulet 3, our next-generation Amulet, and our mitral replacement valve, I think those are all, you know, I've actually been pretty close. I've been closer to the mitral replacement program recently, and the feedback that I've heard from this product is just spectacular. I think it's got the potential to live up to the expectations that we all had back in 2015 when all of us made significant investments in buying early assets, and with the belief that mitral could be as big as TAVR. I think that this is the product that's going to, you know, it's got the potential to fulfill that promise. I put all that together. I think that we're in a tremendously competitive position in structural heart.

The portfolio is very complete, and we're going to continue to invest in it and be a leader here. I feel good about that part of our medtech portfolio and being able to kind of sustain that double-digit growth going forward. I realize we've hit our time here. Let me just make some closing remarks. Delivered another very good quarter. Year to date, we've delivered 7.5% organic growth, 10% EPS, shown that we can expand our op margin profile. We've expanded that by 100 basis points. I think we've delivered all of that, as I said in one of the questions here, with some larger than expected headwinds here that we faced in our businesses that we feel will be kind of behind us next year. Our organic R&D engine continues to be highly, highly productive.

I expect that we'll be able to sustain this performance, this growth as we carry into 2026 and beyond. With that, I'll wrap it up and thank you for joining us today.

Mike Comilla (VP of Investor Relations)

Thank you, Operator, and thank you all for your questions. This now concludes Abbott Laboratories' conference call. A webcast replay of this call will be available after 11:00 A.M. Central Time today on Abbott Laboratories' investor relations website at abbottinvestor.com. Thank you for joining us today.

Operator (participant)

Thank you. This concludes the conference call. Thank you for participating. You may now disconnect. Everyone, have a wonderful day.