Abbott Laboratories - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 delivered resilient growth and execution: revenue $11.142B (+7.4% YoY reported), adjusted EPS $1.26; both slightly above Wall Street consensus, with devices strength and margin expansion offsetting diagnostics headwinds. S&P Global consensus: EPS $1.257 and revenue $11.059B; ABT modestly beat on both.*
• Adjusted gross margin rose to 57.0% (+100 bps YoY) and adjusted operating margin to 22.9% (+100 bps YoY), reflecting cost discipline and favorable mix in Medical Devices.
• Guidance: FY25 adjusted EPS $5.10–$5.20 and organic sales growth (ex-COVID) 7.5%–8.0% maintained; Q3 adjusted EPS guided to $1.28–$1.32.
• The narrative focuses on robust Medical Devices (CGM $1.9B, +21.4% reported) and pipeline milestones (Volt PFA EU rollout, AVEIR progress, Tendyne TMVR approval), with de-risking in Diagnostics amid China VBP and lower COVID testing.

What Went Well and What Went Wrong

What Went Well

• Medical Devices led performance: sales $5.369B (+13.4% reported; +12.2% organic), with double-digit growth in Diabetes Care, Heart Failure, Structural Heart, and Electrophysiology; CGM sales were $1.981B (+21.4% reported) on Libre momentum.
• Margin expansion: adjusted gross margin 57.0% and adjusted operating margin 22.9%, each +100 bps YoY, underscoring productivity and mix benefits. CFO: “Adjusted EPS…was above the consensus estimate” and margins expanded vs prior year.
• Strategic wins: FDA approval of Tendyne TMVR; Volt PFA EU launch and TactiFlex Duo pivotal enrollment ahead of schedule; AVEIR CSP feasibility data; new Georgia cardiovascular manufacturing investment plan.

What Went Wrong

• Diagnostics contraction: total Diagnostics $2.173B (-1.0% reported; -1.4% organic), pressured by lower COVID testing ($55M vs $102M LY) and China VBP; Core Lab grew modestly (+2.2% reported, +1.6% organic).
• Macro headwinds: management cited ~$700M diagnostics headwind (China VBP + COVID testing) and tariffs impact “just under $200M,” with FX still a YoY EPS headwind (roughly ~$0.05).
• Sequential mix: while devices accelerated, diagnostics continued to lag; funding shifts in U.S. foreign aid for HIV testing added pressure to certain rapid testing lines.

Transcript

Operator (participant)

Good morning, and thank you for standing by. Welcome to Abbott's second 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 touch-tone phone. This call is being recorded by Abbott. With the exception of any participants' questions asked during the question and answer session, the entire call, including the question and answer session, is material copyrighted by Abbott. It cannot be recorded or rebroadcast without Abbott's expressed 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. At the halfway point of the year, we are on track with our key priorities and objectives. In the first half, we delivered high single-digit sales growth, over 100 basis points of margin expansion in both gross margin and operating margin, double-digit earnings per share, and we achieved a number of important milestones related to advancing key programs in our new product pipeline. Our sales growth excluded COVID testing sales was 7.5% in the second quarter and 8% in the first half of the year. Our second quarter adjusted earnings per share of $1.26 exceeded the consensus estimate and reflects 11% growth versus the prior year and 16% growth on a sequential basis compared to the first quarter.

I'll now summarize our second quarter results in more detail before I turn the call over to Phil, and I'll start with nutrition, where sales increased 3.5% in the quarter. Growth in the quarter was driven by 6.5% growth in adult nutrition, where Abbott is the global market leader. We continue to see strong demand for our Ensure and Glucerna brands in the markets around the world, and this growing demand is driven by consumers seeking a source of complete and balanced nutrition, especially for those focused on protein-rich diets and meeting the dietary requirements for managing diabetes. Moving to diagnostics, sales declined 1.5% in the quarter, predominantly due to the year-over-year decline in COVID testing sales and the impact of volume-based procurement programs in China. Together, these represent a projected headwind of around $700 million or 750 basis points on the full year 2025 sales growth in diagnostics.

Excluding China, Core Lab Diagnostics grew 8%, reflecting strong underlying demand in the markets around the world. Turning to EPD, our sales increased nearly 8% in the quarter, driven by strong performance in our key 15 markets, which surpassed $1 billion in quarterly sales for the first time. Key 15 markets include India, China, and other markets across Asia, Latin America, and the Middle East. These markets represent the most attractive areas of growth for branded generic medicines. The growth in these markets is supported by favorable long-term healthcare, economic, and demographic trends, including higher birth rates, an expanding middle-class aging population, and growing demand for access to high-quality healthcare solutions. We serve this growing demand by offering a broad portfolio of branded generic medicines tailored to local conditions with a focus on key therapeutic areas.

Additionally, we continue to make good progress toward building a best-in-class portfolio of biosimilars, having completed 10 regulatory approval submissions across a range of emerging markets, with launches projected to begin in 2026. I'll wrap up with medical devices, where sales grew 12%, driven by double-digit growth in diabetes care, heart failure, structural heart, electrophysiology, and cardiac rhythm management. In diabetes care, sales of continuous glucose monitors were $1.9 billion in the quarter and grew 19.5%. In April, we announced a first-of-its-kind collaboration with Epic, enabling direct integration of Libre sensor data into the leading electronic health records system. This seamless integration allows healthcare providers to easily view their patients' glucose data before, during, and after meeting with patients, supporting our goal of simplifying care to help deliver better outcomes for both healthcare providers and patients.

In electrophysiology, we had several key accomplishments in the quarter, including delivering another quarter of double-digit sales growth, initiating the launch of our new Volt PFA catheter, and completing enrollment ahead of schedule in our TactiFlex Duo U.S. pivotal trial. In Structural Heart, growth of 12% was led by a combination of continued share gains in TAVR, strong adoption of TriClip, and contributions from Amulet and MitraClip. During the quarter, we achieved several important milestones that demonstrate our commitment and progress toward expanding our portfolio of solutions to treat mitral valve disease. As the market leader in mitral valve repair, we continue to invest in the success of MitraClip. In addition to currently pursuing a label expansion to increase the addressable market, we recently launched a next-generation version of MitraClip that further enhances the procedure with improved deployment and deliverability.

To accompany our leading position in mitral valve repair, we expanded our focus several years ago to include the development of mitral valve replacement technologies. In May, we announced FDA approval of our Tendyne Mitral Replacement Valve, which offers a new treatment option for those who are not candidates for open-heart surgery or mitral valve repair procedure. At New York Valves Conference a few weeks ago, we provided an encouraging update on the development of our new transfemoral mitral valve replacement product. We acquired this innovative technology as part of our venture investments program, which led to the acquisition of Cephea Valve Technologies in 2019. Following that acquisition, we continued to iterate and enhance the technology, and the FDA recently granted breakthrough designation.

We plan to start the pivotal trial next year and look forward to creating a new solution to help treat the world's most common heart valve disease, which impacts the lives of millions of people around the world. In rhythm management, our strong performance is a result of our strategy to build a comprehensive portfolio capable of significantly outperforming the market on our own historical growth rates. Our growth this quarter of 10% was led by strong uptake of AVEIR, our innovative leadless pacemaker, which is driving growing adoption of leadless pacemakers in both the single and dual-chamber pacing segments of the market. In April, we announced late-breaking data from the AVEIR conduction system pacing feasibility study. This was the first study to evaluate using a leadless pacemaker to deliver conduction system pacing, which is a novel approach to pacing that closely mimics the heart's natural electrical rhythm.

Following the successful outcome of this study, we are targeting to start the pivotal trial next year. In our heart failure business, often overshadowed by other high-growth businesses in our medical device portfolio, sales grew 14% in the quarter. This was driven by balanced growth across the portfolio, which included double-digit growth in ventricular assist devices used to treat both chronic and acute conditions, and double-digit growth in CardioMEMS, our implantable sensor for the early detection of heart failure. In vascular, growth of 3.5% was led by double-digit growth in vascular imaging and vessel closure products, and increasing contributions from Esprit or below-the-knee resorbable stent. Lastly, in neuromodulation, growth of 4% 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, our diversified model continues to provide a strong foundation that is both resilient and designed to sustainably deliver top-tier results now and in the future. That's evident in our performance in the first half of the year, which, along with our outlook for the remainder of the year and the momentum heading into next year, aligns with our long-term sustainable growth objectives of delivering high single-digit growth, healthy margin expansion, and double-digit EPS growth. I'll now turn over the call to Phil.

Phil Boudreau (EVP of 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 second quarter results, sales increased 6.9% or 7.5% when excluding the COVID testing-related sales. Adjusted earnings per share of $1.26 increased 11% compared to the prior year and was above the consensus estimate. Foreign exchange had a favorable year-over-year impact of 0.5% on second-quarter sales. During the quarter, we saw the US dollar weaken, which resulted in a favorable impact on sales compared to exchange rates at the time of our earnings call in April. Regarding other aspects of the P&L, the adjusted gross margin profile was 57% of sales, which reflects an increase of 100 basis points compared to the prior year. Adjusted R&D was 6.3% of sales, and adjusted SG&A was 27.7% of sales.

Adjusted operating margin was 22.9% of sales, which also reflects an increase of 100 basis points compared to the prior year. Based on current rates, we now expect exchange to have a relatively neutral impact on our full-year reported sales, which includes an expected favorable impact of approximately 2% on our third-quarter reported sales. Lastly, for the third quarter, we forecast adjusted earnings per share to be in the range of $1.28-$1.32. 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. Again, that is star one one to ask a question. Please stand by while we compile our Q&A roster. Our first question will come from David Roman from Goldman Sachs. Your line is open.

David Roman (Managing Director)

Thank you. Good morning. I appreciate your taking the question here. Maybe, Robert, you could start by just putting 2025 performance into context for us. As I listen to the walk from the prior guidance to the updated guidance, I think it's pretty clear that it comes from some factors outside the U.S. in diagnostics plus COVID diagnostic headwinds. Maybe you could help us think through the headwinds you're seeing this year, the extent to which those are transient versus more permanent changes in the growth rate, and what that looks like next year.

Robert Ford (Chairman and CEO)

Sure, David. I guess I'll just start off with our goal is to always ensure that every one of our businesses is meeting and beating. The reality is, in the portfolio of Abbott and the complexity and the broadness that we're geographically across the different types of products, you're going to have some businesses that will fall short time to time, and others do better. We've seen that time and again. The goal here, David, is always to really take all of that complexity and just translate it into reliable and sustainable growth. That's what we've been doing this year. When you say characterize your growth this year, listen, we've got a device business that, for the first half of the year, has grown over 12%, double-digit growth in a lot of our businesses.

Our pharma business has done very well, 8% growth in the first half, building the biosimilar portfolio. Nutrition, first half, about 5%, which is in the range that we've always expected them now that we've lapped a lot of the market share kind of recovery process here. Really, the challenge that we've had is twofold here. It's really a drop-off on our COVID testing sales and some challenges in the China core lab market, together with some changes that we've seen in the U.S. foreign aid funding for HIV testing. You look at that and say, "Okay, I'm not sure these are impacts that are 100% definite in the second half of the year, but I'm not going to sit here and try and kind of forecast what COVID testing is going to do." We had expected to see a China recovery in volume.

We knew the price impact in China core lab, David, and we rolled that into our guidance. We had expected a market volume recovery to start happening and, quite frankly, starting in Q2. We haven't seen that, so we've moved that out into Q4. You put all that together, together with the funding for HIV testing, that's over $1 billion of headwind. Even with that $1 billion, we're still forecasting high single-digit growth and absorbing the impact of tariffs, which we now expect to be just under $200 million of impact. FX, as Phil kind of said in his comments, is still a headwind versus prior year on the EPS side, but much less of a headwind than what we had originally kind of anticipated back in January and, quite frankly, April too. That helps offset some of the tariff impact.

I put this all together, and it'll be nice, David, to lap these or to see these headwinds behind us next year. As you look to next year, you've got all this great launch activity across all the businesses, whether it's Volt in the U.S., TactiFlex Duo internationally, the dual-analyte sensor, the launch of the new Alinity system, the biosimilar kind of rollout. I look at all of that and I say, "Okay, you've got this headwind that we're facing here. Still, we're committing to high single-digit growth and double-digit EPS growth." As you look into 2026, those headwinds aren't going to be there. You've got all this kind of great momentum, which I'm sure we'll talk about in other parts of the business. I look at 2026. I know what the consensus are.

They look very reasonable to me in that range of high single-digits, double-digit EPS. It's in line with our historical growth. It's in line with the guidance we're giving this year, and it's in line with what our long-term sustainable growth targets are. It'll be good to see these elements here that I've just kind of highlighted that are specifically to diagnostics. I'll just take it a step further here. If you look at our—and I mentioned this in the opening comments here—our core lab business outside—and I hate doing this, but I think it gives context. If you look at the U.S., it was up 7%, 8%. The European region was up 8%. Our Latin America region was high teens. Our core lab business is doing very well. Alinity is doing very well.

We just got this issue that we're going to have to go through this year as it relates to VBP and the disruption that happened in our core lab business in China. We are still very bullish on this segment. We still believe it's a very important part of the healthcare system. Like I said, looking forward for these headwinds to be behind us, and we're well set up for next year.

David Roman (Managing Director)

That's very helpful. Maybe I just push a little bit harder on one point there. If I look at the guidance for this year, it's really kind of 8.5% when you take out some of those one-time headwinds. One thing you didn't mention was, obviously, in EP, you face a little bit of a portfolio gap this year, and that looks to fully resolve as you head into the back half of the year and into next year. Is there a scenario in which we could see some of these one-time headwinds reverse and see the growth rate accelerate into 2026 and correspondingly see that fall through to the bottom line, recognizing that it's early to talk about 2026, but just conceptually some of these headwinds fading and some of those pipeline drivers starting to kick in more significantly?

Robert Ford (Chairman and CEO)

Yeah. Listen, there's definitely a scenario where you could see that growth rate accelerate. It's a little bit early to kind of put a full stop on that, but there's definitely opportunities across the portfolio, which we'll talk about, likely that say, "Hey, you mentioned electrophysiology." That's been one part of our portfolio that has consistently kind of exceeded the expectations, both expectations, quite frankly, that you guys have had and the expectations that we've had. Yeah, there's definitely opportunity as these reverse out to see that acceleration. Maybe a little bit early to say that, but right now, in terms of where we're sitting for 2026, I feel very comfortable with that.

David Roman (Managing Director)

Excellent. Appreciate your taking the questions and bearing with me here as I have a cold today. Thank you.

Robert Ford (Chairman and CEO)

Yep.

Operator (participant)

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

Robbie Marcus (Senior Analyst)

Oh, great. Good morning. Thanks for taking the questions. Two for me. I'll ask them both upfront, both product questions. Diabetes and EP, both performed really well in the quarter, particularly U.S. Libre. It was good to see U.S. double-digit EP. Maybe just walk through some of the trends you're seeing in each of those product lines, especially in diabetes. There was a lot of buzz around ketone integration and that product coming from Abbott. What are you seeing in diabetes and then also EP, especially now with Volt launching outside the U.S.? Thanks.

Robert Ford (Chairman and CEO)

Sure, Robbie. Yeah, another great quarter of Libre, almost 26% in the U.S., an acceleration internationally also. I think all three segments, we're seeing great momentum. If you look at the intensive insulin user segment, obviously, that's been a key growth driver for the market, but there's still segments there that are under-penetrated, and we're seeing nice growth in there. The new sensor you referenced, I think, is going to definitely accelerate there. The basal segment's doing very well. Big growth driver for us. Still, market leader here, our view globally is we've got about a 70% share. You know some of the markets that have kind of began reimbursing for basal, Robbie. We're starting to see more markets go down this path and start reimbursing basal, whether it's specific tenders and regions or different parts of healthcare systems.

That's good, and we see sustainability to that growth rate and our position in those international markets. The non-insulin user segment's doing very well, very nicely too. I think right now, you've seen commercial coverage here in the U.S., I'd say around about 30% is what we're seeing, and that's doubled over the last three years. I think the trends are doing very nicely there, and I can see that continuing for the foreseeable future as part of our road to $10 billion in revenue. Your question on, or at least your comment on the dual-analyte sensor, I think this is going to be, I think, a real next-level kind of, I'd say, significant change in the CGM market, specifically for the intensive users. Ketone monitoring helps prevent diabetic ketoacidosis. We have a legacy of being in that.

We were the first company to develop a blood test, a rapid blood test for that many decades ago. We know how important it is. It could be life-threatening. The ADA conference you referenced, I thought there was some interesting clinical data that showed—I think it was 30% of pediatric patients and 40% of adult participants saw, in this trial, saw increased ketone levels that put them at risk if there was an interruption on insulin delivery. There's clearly a need for this patient segment. I think you saw all the announcements that came out during the conference with all the pump integration. There's clearly a need there. It's understood. An opportunity to expand even further. We know that ketone monitoring here is going to create a path for doctors to prescribe SGLT2s for type 1s.

These are great drugs that offer a lot of cardiovascular benefits, but they come with a DKA risk. We think that's going to have a huge opportunity too. Good trends in the existing segments right now, Robbie, and I think that our position's just going to be strengthened even more as we bring out the innovation. Looking forward to that. I think on your question on EP, yeah, we saw good double-digit growth in EP this quarter, double-digit growth last quarter. Saw an acceleration in the U.S. growth rate this quarter versus last quarter. A lot of attention now shifting towards rolling out of Volt to the international markets. We like to launch our products in a more kind of limited fashion.

When you move from clinical trials to full-out launch, we like to have this little period in between here, Robbie, where we get to just put it out in a little bit more of an environment that we can just make sure that we're clearly understanding and getting all the feedback in a more direct fashion. When you go a little bit more focused, you get a great opportunity to do that. Really focusing right now on the sites that were enrolled in our trials, and the feedback's been excellent. I think that it stacks up very well versus competitors. I think the balloon design is perfect for PVI. I think it optimizes a lot of the process. If you think about where those prior balloon-based systems were used in Europe, I think this fits very nicely there. Its efficacy is great. Paroxysmal data is best in class.

As we said during the period we were talking about the development of Volt, we believed in mapping and contact and visualization of contact. I think that's what we're seeing from these early cases here, just providing really real-time feedback on tissue contact that leads to fewer applications, leads to less fluoro time, leads to less muscle contraction, which I think is really important if you think about some of the segments globally that are going to start to really advance in terms of market segments, segments that will benefit by having a procedure that could be done without general anesthesia and just with general sedation. I think Volt fits very nicely into those segments there too. So far, so good. The team's doing a great job.

They've been doing a great job over the last couple of years, and I think they're excited now to transition to this phase of the strategy now, which is now that we've gained a lot of market share with mapping, and that's now to bring in the PFA catheter that we think is very competitive.

Robbie Marcus (Senior Analyst)

Appreciate it. Thanks, Robert.

Operator (participant)

Thank you. Our next question will come from Larry Biegelsen from Wells Fargo. Your line is open.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

Good morning. Thanks for taking the question. Robert, I just wanted to ask one follow-up question or multi-part follow-up question on Libre. First, I'd love to get your reaction to the proposed competitive bidding for CGM and what that could mean for you. Second, the RFK Junior comments on wearables. Do you think that could accelerate type 2 non-insulin CMS coverage? Lastly, on the dual ketone sensor, do you think that could drive share gains for you in intensive insulin patients where your share is lower? Thank you.

Robert Ford (Chairman and CEO)

Sure. Three-parter. On competitive bidding, Larry, listen, there was nothing unexpected in the CMS proposal document here. I do not think there are any major changes as it relates to CGM. If CMS chooses to go down the competitive bidding route, it is really going to be the DMEs that are going to be the ones doing the bidding, not the CGM manufacturers. I think this is probably going to take a couple of years to fully implement the process. I do not expect there to be an impact on Abbott, but we are going to continue to monitor. As I have said in other situations, one of the things that we have got to keep on doing here is to be the leader of scale, leader of cost. We will continue to monitor, and we will be ready. Your other question was regarding the comments from the secretary of HHS regarding wearables. Wearables are powerful.

We've known this since we've launched Libre. They're very powerful behavior modification tools, and behavior modification has really proven to really drive significant impact on one's health. I think if you can keep your glucose levels in a healthy range, it offers a lot of benefits. There's lower risk of diabetes, heart disease. It helps with weight loss. We've seen that. It improves productivity, etc. I appreciate the secretary's efforts here to promote improving the health and wellness of all Americans, and I think that's in line with our company's mission and certainly supportive of this initiative. We would hope that it would be Americans wearing CGMs that were made in the United States. We have two manufacturing sites, but anyways, we support that initiative. I think your question was regarding the continuous glucose ketone sensor. Do we think that that can accelerate our share gain? 100% yes.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

Clear. Very clear. Thank you.

Operator (participant)

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

Vijay Kumar (Senior Managing Director)

Hi, Robert. Good morning, and thanks for taking my question. I had one product-related and one P&L question. On the product side, AVEIR CRM is doing really, really well. I guess, are there any metrics you could share on what percentage of your installed base has been updated or converted to AVEIR? Where are we in the conversion cycle? Is this now double-digit or teens for the foreseeable future? What do you think is the ultimate term for this kind of product?

Robert Ford (Chairman and CEO)

I think it's fundamentally changed the growth trajectory of our CRM business, and now you're trying to ask yourself, okay, is this a one-off thing, or can we bank on this? If you look at the trajectory of our CRM business, 2023, when we launched single chamber, our growth rate was 7%. 2024, it was 7%. First half this year, it's 8%, showing 10% growth this quarter. I think that achieving this is very sustainable. I've talked about what we wanted to do here with AVEIR in the past. You've got a $4 billion global pacing market that really hasn't seen much innovation, Vijay. What we wanted to do was to really make sure that as we rolled this out, we weren't just looking for a kind of a niche kind of jump in sales, and then that's it.

The team's done a really good job here in terms of coordinating between marketing and clinical and sales. I think these teams have now really gotten full, are really aligned. I think they're really hitting their stride here to be able to look at expanding not just in the U.S., but also internationally. I think it's the work that they're doing here to be able to get physicians trained and hospitals set up. It's a little bit of a different implant procedure, so you do need to go through that. We took our time to do this and do this right, and I think we're seeing the benefits here of taking that time to do it right. I think it's really driving uptake, not just in single, but without a doubt in dual chamber. We're seeing an increase in the number of accounts from a year ago.

We've seen an increase in the amount of physicians that have been trained. That's increased by 50%. I think it was the last time I saw it. The implants per day have doubled as a result of that. I think it's going very well, and I think I expect to see this outer performance continue here in the next kind of several years. One of the things that we're also doing to kind of be able to support that, and I said that in my prepared comments, was we got to continue to innovate here if we want to be able to kind of support that growth. We'll launch a next-generation AVEIR that's got a 25% longer battery life. That's going to add another two years. We're developing this conduction system pacing product here, which we're targeting to start a pivotal trial in 2026.

I think given the excitement that we have with the product, I think we're going to see kind of good enrollment there too. On top of that, we're rolling it out internationally too. Right now, it's launched in 50 countries. Some of them have been launched for a year or two years. Some of them were just in the process of launching. I think there's a lot of good momentum here with this portfolio, not just in terms of execution out in the market, but also in terms of R&D and clinical work.

Vijay Kumar (Senior Managing Director)

That's helpful. Maybe one P&L on the EPS guidance here. The top end was lowered by $0.05, and midpoint was maintained despite, I think, operating margins tweaked down, organic coming down. Where are the offsets here? Maybe some comments on what is underlying operational versus perhaps change in FX and tariff assumptions?

Robert Ford (Chairman and CEO)

I'll let Phil take that one.

Phil Boudreau (EVP of Finance and CFO)

Yeah. Thanks, Vijay. Very quickly here, Robert touched on some of the sales drivers and kind of de-risking elements there. We also touched on kind of the FX impact going forward at current rates at least, and kind of that relationship that's not a one-for-one fall through, just kind of the mechanics of how inventory moves through the system and the like. While there's a neutral top line impact, there's still a headwind both year over year, as Robert touched on in his opening comments. That's still a headwind on the bottom line here, along with kind of tariffs kind of rolling in the second half of the year as those work their way through inventory as well. Those are the elements of de-risk and then kind of normal headwinds.

Vijay Kumar (Senior Managing Director)

Sorry, could you quantify what was tariff contribution versus operational FX?

Phil Boudreau (EVP of Finance and CFO)

Yes. I think Robert mentioned tariffs are a little less than $200 million impact here, so down from previous estimates. Then the FX impact here, I think over the last several years, if you look at it on average, we face on average about a 4% EPS headwind on the bottom line. That kind of moves as currencies will and do, along with factors on inflation and interest rates and the like. We are in that same realm of impact, a little less than that historical 4%, but certainly year-on-year negative impact from FX of roughly a nickel.

Vijay Kumar (Senior Managing Director)

Got it. Thank you.

Operator (participant)

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

Travis Steed (Managing Director)

Hey, thanks for taking the question. First question was on M&A. Just kind of curious how you're seeing the pipeline shake up in diagnostics and med tech, and if you could see Abbott do a more sizable transaction this year on the M&A side. It sounds like on EPS, you're comfortable with the street consensus double-digit EPS growth next year. Is that assuming tariffs at the current rates, or do you have a lot of some P&L flexibility next year as well if tariff rates move a bit from here?

Robert Ford (Chairman and CEO)

Sure. What was the first question again? Oh, M&A.

Travis Steed (Managing Director)

M&A.

Robert Ford (Chairman and CEO)

Yeah. Yeah. It's a good environment for M&A. Good opportunities out there. Got a strong organic pipeline, so that allows us to be a lot more selective here. We're seeking the opportunities that will fit us strategically and going to generate an attractive return. Not looking just to acquire a business to make our top line larger here. Profitability, as I've said, the earnings, the ROIC, that all matters to us. Your question on EPS for next year, does it include FX? Listen, it includes what we know right now, Travis. As we're all going through, they can change. They can kind of move around. As I said in the call in April, our goal here is not to focus on mitigating items that would cause a year-over-year kind of impact. We didn't go out and build a bunch of inventory over the last couple of months.

We did do some of that where we thought it was important to do, but using that as the way to mitigate tariffs this year is going to cause, I think, headwinds if you just rely exclusively on that. As we have said, we have a whole team that has been working on this. There are like six different work streams that we are looking at. We have got a very strong manufacturing network around the world, around 90 manufacturing sites. We are going to build another cardiovascular manufacturing site here in the U.S. and begin that process also. We are thinking about it once tariffs get set in place. They are very difficult to walk away from. We have to think also medium term, but also long term.

Travis Steed (Managing Director)

Great. Thanks a lot.

Robert Ford (Chairman and CEO)

Yeah.

Operator (participant)

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

Danielle Antalffy (Equity Research Associate)

Hey, good morning, guys. Thanks so much for taking the question. Robert, I actually just have—I'll keep it to one product question, and that's within med tech, specifically Structural Heart. You guys have been launching Amulet for a while now, and we have a pretty potentially big game-changing trial readout coming for your competitor early next year, which to me feels like a rising tide floods all boats situation potentially. I'm just curious, looking at the Structural Heart consensus estimates for next year, modeling deceleration, I just have to imagine that that could actually accelerate Amulet growth. I would just love to hear your thoughts on how you're thinking about that and the potential TAM expansion that I think would be a class effect for both devices that are on the market today, and sort of how you're factoring that into the long-term outlook here for the Structural Heart business.

Thanks so much.

Robert Ford (Chairman and CEO)

Sure. Yes, I concur with all the things you've been talking about there, as this is a very important kind of growth opportunity that we see also. A competitor has been investing in a trial that could potentially expand the market, so are we. We have our own trial here. I think it's going to be important to have the data to be able to kind of support your product. We've made that investment. We should complete enrollment in our trial this year. Like I said, if these are all great trials and positive trials, I think it's going to have a big impact here in terms of our ability to expand the market. Our job also, we're not the market leader, so we have things that we also have to address.

We've spent a good amount of R&D money, Danielle, to make sure that we can accelerate here our second-generation device. We're enrolling in that pivotal trial. I'd say what we were trying to resolve there was, or improve upon, is we've got great—we've got a superior sealing capability, and we've got this much broader range of ability to hit a lot of different types of anatomies. One of the feedbacks that we got is, "Can you make it easier for deployment and delivery?" Teams have done a really good job with that. The feedback that I have gotten, not only from my team, but also from the physicians that are enrolling in our trial for this next-generation product, has been spectacular. Very positive on those issues that we were trying to improve upon.

We think this is a very strong opportunity for us, tying in with our EP and AFib procedure. We know there's a growth in concomitant procedures here too. I think that this is an important growth driver for us. I share your view. I think that our product here is very competitive, and it's going to become very, very competitive as we launch the second generation.

Danielle Antalffy (Equity Research Associate)

Thanks for that.

Operator (participant)

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

Josh Jennings (Managing Director)

Hi, good morning. Thanks for taking the question. Wanted to just ask about your TAVR franchise. Maybe Robert, if you could help or share your expectations for market growth here. The commercial effort for Navitor, and then the addition of this pipeline, balloon expandable, and cannula platform. How does Abbott view the market, and how do you see the franchise taking share, and what will drive that? Thanks for taking the question. Just a quick nuance. If you can talk about anything that you're seeing in Europe with the Boston exit and Navitor uptake or share gains from that competitor event, that'd be great. Thanks for taking the questions.

Robert Ford (Chairman and CEO)

Sure. Listen, we wanted to be—our vision here is to be the leading Structural Heart company, global Structural Heart company. The only way you can actually do that is to really have a full portfolio of products here. Obviously, I talked a little bit in my comments about mitral. We've made the investments in the tricuspid area and making investments in the TAVR side too. Specifically on TAVR, Navitor continues to get a lot of positive feedback from the physicians. It's a very compelling offering. It's excellent valve design, easy to implant. Got great clinical data. Our sales have doubled over the past two years. The big driver of that, I would say, over these past two years has been international, has really been the driving factor here of success, and I expect that to continue.

There's an opportunity here to accelerate that growth internationally with a competitor market exit. I know the team's all over that. With the upcoming CE mark that we have planned for Navitor to have low and intermediate risk label expansion, it could not come at a perfect time, to be quite honest with you. I expect that to continue and accelerate for us, Josh. We are building our position here in the United States. Right now, we are in about 20% of the centers in the United States. The way to expand our position here is we got to be in more centers. The way to do that is you need more clinical people, you need more feet on the street. That is what we are doing.

We will be doubling the size of our team, and I'd say putting ourselves in the realm of being more competitive in terms of access to sites by the end of this year. We'll have doubled it versus last year. There's a normal ramp-up in terms of rep productivity that we know in this space. All the people that we've been adding, I expect that now start to really have a nice impact as we go into 2026. It's definitely a competitive space, there's no doubt. I think here between the commercial investments we've made in the United States, the opportunity we have with label expansion and just market disruption in international markets, I think that is a tailwind for us too there.

Once you commit yourself to developing next-generation kind of balloon expandable TAVR, that also opens up a nice opportunity for us, even though that'll probably be more towards the end of this decade in terms of full launch. It does help as you're rolling out all these strategies that I've talked about. We feel good about the TAVR team's doing a good job. Like them to do better, but so far, so good. There's a lot of good momentum for us on this business.

Josh Jennings (Managing Director)

Appreciate it. Thank you.

Operator (participant)

Thank you. Our next question will come from Adam Maeder from Piper Sandler. Your line is open.

Adam Maeder (Senior Research Analyst)

Hi, good morning. Thank you for taking the questions. Two quick ones for me. I'll ask them both upfront. Robert, first was hoping for an update on incentive formula litigation and the MDL process, and how you think about potential pathway to resolution from here. For the second question, wanted just to go a little bit deeper on the dual-analyte sensor, specifically around expected approval and launch timing. Is that first half 2026? Pricing strategy and how quickly you'll integrate with the different pumps. Thank you for taking the questions.

Robert Ford (Chairman and CEO)

Yeah, sure. Listen, I'm not going to comment specifically on any kind of upcoming case regarding the neck litigation. I'm going to commit to what I've always said, which is this is a product that has been supported by the medical community, by the regulatory community, by the scientific community. It's been in the market for a long time. It does not represent much to our revenues. We stand behind the product. Its safety. The regulators have stood behind it and kind of issued statements about the product. We're going to stand behind it if we need to take action on the product. Like I've said in the past, it's a small part of our revenue. If we have to take action on the availability of that product, we will.

If the science is not respected, if the regulatory process is not respected, if the medical community is not respected, then it's going to be difficult to keep that product on the market. So far, I think there's been a lot of support from the physicians and from the regulators, a lot of support from a variety of different stakeholders to want to see this resolved and this product remain on the market. Ultimately, those making the decisions on how to feed the most vulnerable of the American citizens here should be physicians and neonatologists and not lawyers and courtrooms. Sorry, what was your second question?

Adam Maeder (Senior Research Analyst)

Sure. The second question was just a couple of follow-ups on the dual-analyte sensor. Wanted to just better understand expected launch timing in the United States, if you're giving any color around pricing strategy and just how quickly you'll integrate with the different pump players. Thank you.

Robert Ford (Chairman and CEO)

Okay. Three questions there. On timing, I'm not going to talk about timing of that. I'm not going to talk about when we've submitted, how we've submitted. All I'll say is that this is a first time that you'll have a sensor that will measure continuously two different analytes. We've done a lot of clinical work, approximately five different trials to be able to support its submission. We've already completed those trials. I'm not going to give timelines as to when the product's out. Neither am I going to give any details on pricing and how we will think about pricing. As it relates to integration, one of the reasons we wanted to line up, have the conversations with the different insulin delivery pump companies is to make sure that when we do have it approved, that it will be available as quick as possible for the population.

Phil Boudreau (EVP of Finance and CFO)

As you saw during the ADA, there were some announcements over there, and I think that's a little bit of the strategy behind that.

Adam Maeder (Senior Research Analyst)

Thank you.

Operator (participant)

Thank you. Our next question will come from Matt Miksic from Barclays. Your line is now open.

Matt Miksic (Equity Research Analyst)

Hey, thanks so much for taking the questions. We've covered a lot of the products and some of the key elements of the quarter and the guide. Maybe just a couple of quick follow-ups. One on M&A. I know you remain an important part of your strategy. Love it if you could share any color as to kind of where you see the next most likely kind of investments or where you think there are kind of gaps in the portfolio you'd like to fill, whether it's tricuspid or in diagnostics or across the board. That'd be super helpful. Thanks.

Robert Ford (Chairman and CEO)

Yeah. I get that people always like to triangulate. I'm not going to tell you, I'm not going to telegraph where we're going, but I've been pretty clear. It's diagnostics, it is devices. Those are the areas that are of interest to us. Like I said, there's a lot of opportunity in both those areas. We'll just continue to apply the framework that we've always applied to when we do M&A, which is a belief that can we make these assets better? Can we bring them to more people? Can we bring care to more people as a result of them? I don't think I've got more to add on that, Matt. On top of that, like I said, we've got great growth rates here right now across the businesses. Again, that puts us in a space where we can be a little bit more selective.

Matt Miksic (Equity Research Analyst)

Great. We'll leave it there. Thanks.

Robert Ford (Chairman and CEO)

Okay.

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

Operator (participant)

Thank you. Our last question will come from Marie Thibaut from BTIG. Your line is now open.

Marie Thibault (Managing Director)

Hi, thank you for taking the questions. Wanted to follow up here. You've mentioned that we'll see biosimilars on the market soon. Wanted to get a little more detail on how to think about kind of the reach of those products, the investments needed on your end, maybe in SG&A and things, and the size of some of those markets that you're trying to reach. Thanks for taking the questions.

Robert Ford (Chairman and CEO)

Sure. This is an opportunity for us to really look at how do you sustain that growth rate in this business. This is a business that has been growing between 8% and 10%. It's learned through a very strong management team how to manage through kind of FX cycles and inflation in markets, so they've been able to expand margins. This is about how do we do this in a capital-efficient way to bring more assets to an existing infrastructure that's pretty well set up, Marie, between the salesforce that calls on the doctors, that calls on retail distribution, the teams that we have in place that work with government agencies and regulators. The infrastructure in place is there. Do I think that there will be some need to add some SG&A to be able to educate the market?

Because this is a very under-penetrated market when it comes to biologics. There is some SG&A involved in that, but it's not like you're really taking advantage of the infrastructure and the scale that you have in these markets across different channels and regulators to be able to add in this. I think we'll leverage our existing presence in these emerging markets. We're going to bring these cutting-edge medicines into these countries that I say that historically lack the access. The predominance of the diseases are just as large from a % perspective than they are in the developed markets. If you look at the portfolio, we've looked at where the areas that we think will be of interest. Autoimmune disease, women's health, oncology, access to GLP-1s. The team has really done a good job here laying in here a real nice pipeline of products.

As I said, we're going to start launching in a small market this year, and then we'll start rolling them out, obviously, as they become, from a regulatory perspective, available to us. We'll be rolling them out next year. I think this can be a nice contributor here to our growth in this business in the next few years. Okay. Listen, I'll just make a few comments here to close. I'm pleased with what we've accomplished in the first half. We've delivered high single-digit sales growth and double-digit EPS. We've expanded our gross margin and operating margin, which is something that we've committed to and we've talked about, and we've done it by about 100 basis points.

The second half sales growth guidance is de-risked to account for some of these items here that I consider to be a little bit more transitory that are specific in the diagnostic space, and we're going to be lapping these next year. That still leaves $11+ billion quarterly revenue growing high single digits throughout the rest of the year. On top of that, we've reaffirmed our guidance despite some of these headwinds and the impact of tariffs. I think this is another great example of how our diversified model continues to provide that strong foundation. It's resilient, and it's well-positioned to deliver top-tier results. We've got good underlying momentum here that I'm very confident we'll carry into next year. With that, I'm going to wrap up. Thank you for joining us.

Mike Comilla (VP of Investor Relations)

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

Operator (participant)

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