Abbott Laboratories - Q1 2024

Transcript

Operator (participant)

Good morning, and thank you for standing by. Welcome to Abbott's First Quarter 2024 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. 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. It cannot be recorded or rebroadcast without Abbott's 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; Bob Funck, Executive Vice President, Finance; and Phil Boudreau, Senior 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 2024. 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 31, 2023.

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 GAAP financial measure for organic sales growth on a forward-looking basis because the company is unable to predict future changes in foreign exchange rates, which could impact reported sales growth. 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 B. Ford (Chairman and CEO)

Thanks, Mike. Good morning, everyone, and thank you for joining us. Today, we reported first quarter adjusted earnings per share of $0.98, which was above analyst consensus estimates. We also raised the midpoint of our guidance ranges for both earnings per share and sales growth. We now forecast full-year adjusted earnings per share of $4.55-$4.70, and organic sales growth excluded COVID testing-related sales of 8.5%-10%. Organic sales growth, excluding COVID testing-related sales, was 10.8% in the quarter, which represents the fifth consecutive quarter of double-digit growth. This strong start to the year was driven by broad-based growth across the portfolio, including growth of 14% in medical devices and established pharmaceuticals.

In addition to exceeding expectations of both top and bottom lines this quarter, we accomplished a number of objectives across the pipeline, including obtaining several new product approvals and achieving important clinical trial-related milestones. I'll now summarize our first quarter results in more detail before turning the call over to Phil. I'll start with nutrition, where sales increased 8% in the quarter. Strong growth in the quarter was led by double-digit growth in pediatric nutrition, driven by continued market share gains in the US infant formula business and growth across our international portfolio of infant formula, toddler, and adult nutrition brands. In January, we launched a new nutrition shake called Protality, which provides nutritional support for adults pursuing weight loss.

As people eat less and lose weight from taking GLP-1 medications, undergoing a weight loss surgery, or following a calorie-restricted diet, a portion of what is lost is lean muscle mass, which plays an important role in overall health. Combination of high protein and essential vitamins and minerals that Protality offers can help people preserve muscle while pursuing their personal weight loss goals. Turning to EPD, where sales increased 14% in the quarter. This quarter was a continuation of EPD's impressive trend of strong performance, including double-digit growth in four of the last five quarters.

In addition to a strong track record of top-line growth, this business has delivered equally impressive gains on the bottom line, with an operating margin profile last year that reflected more than 350 basis points of improvement compared to 2019. Moving to diagnostics, where sales increased more than 5%, excluding COVID testing sales. Growth in diagnostics continues to be led by the adoption of our market-leading systems and demand for testing that takes place in a variety of settings, including hospitals, laboratories, urgent care centers, physician offices, retail pharmacies, and blood screening facilities. Our development efforts in diagnostics focus on developing new systems and creating new tests that play an important role in making healthcare decisions, expand the accessibility of testing, and deliver a result as fast as possible.

In April, we received FDA approval for a point-of-care diagnostic test that can help determine if someone suffered a mild traumatic brain injury or concussion in just 15 minutes. The test is run on our portable i-STAT Alinity instrument, which allows concussion testing to move beyond the traditional hospital setting and into urgent care centers, physician offices, and other locations that are closer to the patient. With nearly 5 million people in the U.S. going to the emergency room to be checked for suspected concussion each year, we believe this test has the potential to transform the standard of care for concussion testing. And I'll wrap up with medical devices, where sales grew 14%. In diabetes care, FreeStyle Libre sales were $1.5 billion in the quarter and grew 23%.

I've previously mentioned that Libre has several new growth opportunities that will help continue to fuel the strong sales trajectory we have forecasted. One of those growth opportunities relates to the continued expansion of reimbursement coverage for Libre, for individuals who use basal insulin therapy to manage their diabetes. Last year, we announced that Libre became the first and only continuous glucose monitoring system to be nationally reimbursed in France to include all people who use basal insulin as part of their diabetes management. During this first quarter, Libre obtained reimbursement from a select number of institutional payers in Germany for basal insulin users who also use oral diabetes medication to manage their condition.

These select public and private payers cover a limited number of the approximately 1 million basal insulin users in Germany, but this is an encouraging sign of the potential for further coverage expansion, not only in Germany, but across other European markets. In cardiovascular devices, sales grew 10.5% overall in the quarter, led by double-digit growth in electrophysiology, structural heart, and continued acceleration in our cardiac rhythm management and vascular portfolios. In electrophysiology, sales grew 18%, driven by double-digit growth in all major geographic regions and across all major product categories, including double-digit growth in ablation catheters and cardiac mapping-related products. We continue to make great progress toward bringing our innovative PFA catheter, Volt, to market. In March, we completed enrollment in our CE Mark clinical study, putting us on track to file for international approval before the end of the year.

We also recently began enrolling patients in our U.S. clinical trial called VOLT-AF, which will generate the data needed to support an FDA approval filing. In structural heart, growth of 13% was led by strong performance in several high-growth areas, including TAVR, LAA, mitral, and tricuspid repair. Structural heart is an area that we have invested in over the past years in order to create a diversified portfolio that can sustainably deliver double-digit growth. In the past, we relied almost exclusively on MitraClip to drive the growth, but today, the portfolio and growth are more balanced and reflect increasing contributions from newer products like Navitor, Amplatzer Amulet, and TriClip. In April, we received FDA approval for TriClip, a first-of-its-kind heart valve repair device designed for the treatment of tricuspid regurgitation or a leaky tricuspid valve.

Data from the clinical trial supporting this approval demonstrated that patients who received TriClip experienced a significant improvement in the severity of their symptoms and quality of life. We're excited to now offer this life-changing treatment option to people in the United States that suffer from this condition. In rhythm management, growth of 7.5% was led by AVEIR, our recently launched leadless pacemaker. AVEIR has rapidly captured market share in the single-chamber pacing segment of the market and is now being used for dual-chamber pacing, which is the largest segment of the pacing market. This revolutionary technology is helping to deliver growth rates in our rhythm management business that significantly exceed the overall growth in this market. And lastly, in neuromodulation, sales grew 17%, driven by Eterna, a rechargeable neurostimulation device for pain management. And in January, we announced the launch of Liberta....

the world's smallest rechargeable deep brain stimulation device, which is used to treat movement disorders such as Parkinson's disease. So in summary, we're off to a very good start to the year, exceeding expectations on both top and bottom lines, and as a result, we raised the midpoint of our sales and EPS guidance ranges. We continue to make good progress on our gross margin expansion initiatives, and we're seeing strong returns from the investments we're making across our growth platforms. Our pipeline has continued to be highly productive, delivering several recently new product approvals, and we're very well positioned to continue to deliver strong results for the remainder of the year. Now I'll turn over the call to Phil.

Philip P. Boudreau (EVP 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 first quarter results, sales increased 4.7% on an organic basis, which, as expected, includes the impact of year-over-year decline in COVID testing-related sales. Excluding COVID testing sales, underlying base business organic sales growth was 10.8% in the quarter. Foreign exchange had an unfavorable year-over-year impact of 2.9% on first quarter sales. During the quarter, we saw the US dollar strengthen versus several currencies, which resulted in exchange having a more unfavorable impact on sales compared to exchange rates at the time of our earnings call in January. Regarding other aspects of the P&L, the adjusted gross margin ratio was 55.7% of sales.

Adjusted R&D was 6.7% of sales, and adjusted SG&A was 29.4% of sales in the first quarter. Lastly, our first quarter adjusted tax rate was 15%. Turning to our outlook for the full year, we now forecast full-year adjusted earnings per share of $4.55-$4.70, which represents an increase at the midpoint of the range compared to the guidance range we provided in January. We also raised the midpoint of our guidance for organic sales growth. We now forecast organic sales growth, excluding COVID testing, to be in the range of 8.5%-10%. Based on current rates, we expect exchange to have an unfavorable impact of approximately 2.5% on full-year reported sales, which includes an expected unfavorable impact of approximately 3% on second quarter reported sales.

Lastly, for the second quarter, we forecast adjusted earnings per share of $1.08-$1.12. With that, we'll now open the call for questions.

Operator (participant)

Thank you. At this time, we will conduct a 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's star one one to ask a question. Please stand by while we compile the Q&A roster. Our first question will come from Robbie Marcus from J.P. Morgan. Your line is open.

Robbie Marcus (Analyst)

Oh, great. Thanks for taking the question. Congrats on a nice first quarter here. Two for me, I'll just ask them both up front. First, Robert, you know, we almost never see Abbott raise guidance, particularly on the top line in the first quarter. Looking back over the past, I don't know, 5, 10 years, it's very rare. So first part is: What gave you the confidence to raise the midpoint of the guidance this early on in the year? And then second, you know, obviously, there's been a lot of concern during the quarter with competitors' loss in a case for NEC as it relates to infant nutrition. I was hoping you could address that, you know, what's your stance on the ongoing litigation?

I think there's about 1,000 cases that have been filed, and any upcoming data points or timelines we should be looking for. Thanks a lot.

Robert B. Ford (Chairman and CEO)

Sure, Robbie. So let's go first to your question on the guidance. Yeah, you're right. I guess I had to go back and take a look at that. I think the last time we did raise in Q1 was in 2016. I'd say the framework here, Robbie, as we've always done, is we set a guidance at the beginning of the year, which we believe is top tier. And then throughout the year, we want to beat that guidance, right? And we consider top tier to be, you know, high single digit, double digit EPS growth. And you know, that's obviously excluding the COVID testing portion, which, you know, is what investors are really more focused on.

So that was the guidance that we set, you know, a couple of months ago back in January, and, you know, we'll target always have that top-tier guidance and find the appropriate balance between, you know, the opportunities and, you know, and obviously the challenges that, you know, bracket that range. If you remember, in January, I said I thought that there was more opportunities than risks. And, you know, I think that some of the risks that, you know, we saw in January, I still think, you know, they're they haven't gone away. They're still there, whether it's geopolitics or whether it's FX, those are still there. But clearly-...

The performance of the business continues to be very, very strong, and in some of our businesses, a lot of our businesses, actually accelerating our performance. So this, as I said in my comments, five consecutive quarters of double-digit growth here. So, and so you look at each of the businesses, you know, EPD, you know, three consecutive years of double-digit growth, great margin expansion, and the teams are now working to be able to introduce, you know, biosimilars in all the markets that, you know, that we're participating in. Nutrition has done an incredible job at recovering share, and growing our adult business. You know, we've grown adult over $1 billion versus 2019. Diagnostics continues to have a great track record here of outperforming the market.

We've got some great large account wins, both in the U.S. and internationally, that we're rolling out into this year. And medical devices, I mean, what can I tell you? It's just been a real strong performer. The team's done an incredible job there. Last year, we were the fastest growing med tech company. At least from what I've seen from our guidance and from the other guidances in the market, that's what it seems to be again this year. So you put all that together, plus the pipeline that's been contributing to an accelerated level, great new product approvals. I put all that together, and I just feel that this type of performance that we deliver just gives us the confidence for the remainder of the outlook of the year.

So we felt comfortable raising the guidance again, you know, in the first quarter, which is, you know, as you pointed out, something that we don't, we don't usually do. And I continue to believe going into, you know, going into the second quarter, as we move through, that there's probably more opportunities than risks here, as we move forward. So, I guess that's the framework of raising our guidance in the first quarter, which is something that we usually don't do, just great performance and great momentum. And then your other question was regarding the NEC cases.

I'd say from a date, yeah, we have some court cases that will happen in July, so that's maybe, you know, a milestone that we want to look at. But if you were asking me about kind of our framework of how we look at this, I'd say for decades, we've provided specialized nutrition products that help doctors, and I think that's a key thing here. It helps doctors provide the life-saving nutrition to the premature infants. And how you feed a premature infant, it's a medical decision, Robbie, and healthcare providers, they're gonna use a range of options to meet the unique needs of each baby.

And that includes mother's milk, that includes pasteurized donor's milk, but that also includes pre-term infant formula, because where mother's milk is not available, there is not a sufficient supply of donor milk to satisfy the nutritional needs of all of these premature infants that are born in the U.S. And quite frankly, even when they're available, for some premature infants, human milk may lack some of the calories, the proteins, the vitamins, et cetera, that are necessary to support the nutritional needs of the premature infants. So you know, that milk, that mother's milk needs to be fortified in order to boost the nutritional output. And the medical community, they consider these products to be critical, a critical part of the standard of care for feeding premature infants.

You know, most of the societies, when you read their, you know, when you read their positions, it is a standard of care to use these products. So the doctors who work in the NICUs, they've used our products for decades, and they continue to do so today. And countless babies, Robbie, have benefited from these products, life-saving experiences over many, many years. And there are clinical studies that have repeatedly established that these products are safe. So, you know, so these litigation cases, they're really seeking to advance a theory promoted by plaintiff lawyers that distorts the science, and it distorts, you know, distorts everything that we know, and it's not supported by the medical community.

You know, we're preparing for our cases to be able to kind of lay out, you know, the facts, the science, and the data, and we stand behind our products.

Robbie Marcus (Analyst)

Appreciate it, Robert. Thanks a lot.

Operator (participant)

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

Larry Biegelsen (Analyst)

Good morning. I'll echo Robbie's congratulations on the strong start to the year here. Thanks. So Robert, I just wanted to focus on EP. So a multi-part question here, but just one. So the EP business grew nicely in the first quarter in the U.S. and outside the U.S. Can you talk about what drove that? You know, what you're seeing with PFA in the different geographies, your expectations, you know, for your EP business going forward, you know, before the Volt launch. And just lastly, so it sounds like we should expect the Volt approval in Europe sometime next year, based on the filing date. Just want to confirm that. Thanks for taking the question.

Robert B. Ford (Chairman and CEO)

... Sure. Yeah, like I said in my opening comments, we completed the trial. There's a six-month follow-up, Larry, so that means that we will be on target here to file for, you know, CE mark by the end of this year. And then it's just gonna depend on, you know, on that process. So I think that's probably our anchor point here, is getting the filing in before the end of the year. Yeah, I mean, I'm not surprised by our EP growth. I know many on the call might be, but I'm not surprised. We... You know, first of all, it's an important therapy.

It's an under-penetrated disease, so we know there's plenty of growth in this segment. And as a result of that, it's, you know, it's highly competitive, right? So, but I-- you know, we haven't been surprised by the growth. You know, if you look at PFA, it's been in Europe for three years. If you average our growth rate over those last three years in Europe, we've been growing, we've been growing mid-teens. And, the growth, it remains broad-based. It was broad-based in Europe again this quarter, where we saw double-digit growth in ablation catheters, so not just on the mapping side, on the ablation catheter side also. But then also great growth on the mapping side. And, yeah, this technology has now come to the U.S.

I think we've probably had maybe two months of seeing the technology be rolled out here in the U.S. I think the competitors have been, you know, very aggressive here in terms of bringing the technology to the accounts in the U.S. And I can say, we've mapped a lot of those cases, Larry. I'm not gonna say we've been in every single case, but I'd say, a vast majority of the cases we've been in there. And, there are some similarities to Europe, but there are some differences to Europe. I think one of the things that we saw in Europe was that there was this inclination to use the technology starting off as kind of a one shot.

So that had an impact more on, you know, the cryo business than I would say on the RF side, and that's what we saw in our mapping cases. We saw here, at least in the first couple of months, that's where the large portion of those cases occurred, at least the ones that we mapped, were in places where they were traditionally using cryo. I think the difference that we saw a little bit in Europe is that, at least 90% of the cases that we were part of, directly or indirectly, were using mapping. That number was lower in Europe, so that's probably a little bit of the difference I saw here in the US. And that bodes well for us, right?

Our EnSite system, our mapping system, our mapping catheters are widely viewed as an excellent option here for mapping these PFA cases. We have a large installed base, customers are familiar with it, don't need to make room, don't need to fight for capital. We've got best-in-class clinical support, and the architecture here is open, as I've said in previous calls, so it integrates well with these PFA catheters. We actually recently released a software upgrade last month, that provides even better visualization to these catheters, and potential for faster procedures and less fluoro time. So, I think this is a perfect combination, quite frankly, in a time where there's gonna be, you know, market transition.

There's a lot of new products, there's a lot of choices, and when you have a situation like that, I think flexibility is key, and that's what we heard from our customers. One data point that I thought was also interesting, to your question of what helped drive that, in the cases that we were a part of and we saw, we also observed that an RF catheter was pulled in about a quarter of the cases that we saw. So on top of the PFA catheter, an RF catheter was pulled, you know, to do touch-ups, et cetera.

So, you know, I, I'd say right now, everything that we've seen in Europe, you know, on the positive side is happening, and then I think there are some, some interesting dynamics here in the U.S. that could be favorable for us also. But it's still very early. And, you know, if I look at March, we had probably one of our highest months. We look at cases per day. So, so this, you know, so far so good, and, you know, we're excited about the technology, we're excited about our program. We released data on our program in some recent medical meetings that occurred.

The feedback from those that have been using our products are very positive, and the integration with EnSite, including, like, the tissue contact force algorithm and the visualization, all of that is seen as a real promise and a differentiator versus what's being used today, so.

Larry Biegelsen (Analyst)

Thanks so much.

Operator (participant)

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

Joshua Jennings (Analyst)

Good morning. Thanks for taking the questions, and great to see the strong start here, Q1 results. Robert, I was hoping to just ask first on Libre, and just internationally, any other payment or coverage decisions that we should have on our radar in various countries? Sounds like you've made some nice progress already in Germany. In the U.S., I was hoping you could just help or share your thoughts on the share gain opportunity in the integrated pump segment of the CGM market versus the share loss risk in the Type 2 non-insulin cash pay segment with the competitive launch here in early 2024. I just have one follow-up.

Robert B. Ford (Chairman and CEO)

... Sure. On the, on your international question, I mean, it's always difficult to forecast exactly, you know, by month or quarter, you know, coverage kind of payment decisions. I can tell you, though, that the team has a, you know, full global map of all the work that's being done, you know, regarding clinical information and negotiations, et cetera. So, so it's difficult to kind of forecast it, but what I have said is, is, you know, on previous calls and on some of my prepared remarks, that I think you're gonna see this, you know, just this, this build that will be occurring globally, in the market as the data, proves and shows the, you know, the clinical, medical, and health economic benefit by reimbursing for this patient population, and I think we're well positioned there.

Internationally, I think we got some pretty large markets already, Canada, Japan, France, Italy, Germany. Those are markets that are, you know, you know, either fully reimbursed or starting their process. And like I said, I think you'll see, you know, as the year progresses, you know, whether it's in, you know, medical events or just as the year progresses, I think you'll see more, coverage decisions. You know, maybe they don't get splashy, you know, big PR news, but we are seeing continuous, increasing there, on that. On the US side, I guess I disagree with your premise, that I'm gonna be trading share gains on the pump side for share losses on the non-insulin side.

I mean, I'm just right now looking at the data, third party audited data, seven out of every ten new prescriptions for this basal population, which is primarily, primarily served by the primary care channel, seven out of ten are going to Libre, and I think our product's gonna get even more competitive and our objective here is to maintain kind of our share dominance and our share leadership, as it results to, you know, as it results in this patient segment.

But we do have an opportunity here to, you know, to participate a little bit more actively in what is a little bit more of a smaller segment of the population, but nonetheless, a very important one, which is the, you know, AID and the market system. So, you know, there are 150-200 thousand new starts a year. There's an opportunity for share gain also of existing users. I think that the opportunity to bring a dual analyte sensor with ketones, we showed some data at ATTD this year that showed, you know, the safety benefit, or the value proposition of a dual analyte sensor for an AID system. So I think that's gonna be a compelling value proposition.

Then we're working with all the pump companies here, and I think as the year progresses, we'll see connectivity occur, whether it's with Libre 2 Plus, our streaming product, or whether it's with Libre 3. So, you know, this is an area that we're focusing on, and it's a new segment for us to compete in, but I don't think that we're gonna be taking our eye off the ball as it relates to, you know, as it relates to, you know, the basal opportunity that exists, so.

Joshua Jennings (Analyst)

Understood. Thanks. Then just wanted to ask on the transcatheter tricuspid market. Congratulations on the TriClip approval, but there's been some questions around the patient opportunity breakdown between TEER and TriClip and replacement with Evoque. Maybe just any internal team thoughts on that patient opportunity breakdown, and then anything you could share on the pricing strategy for TriClip in the setting of competitor pricing, its replacement device at a significant premium. Thanks for taking the questions.

Robert B. Ford (Chairman and CEO)

You know, I'm not gonna comment on our pricing strategy here just for competitive reasons. You know, it is a differentiated and novel technology, so there is an opportunity, but you know, we'll have to see how this all plays out. You know, you got NTAP submissions and all this stuff going on right now. What we're focused on here is launching the product, and getting cases ramped up. And that's what's happening. I got some feedback yesterday from the team after a couple of weeks, a real nice cadence of growth. We're obviously focusing our initial cases on, you know, most of the accounts that were part of our pivotal trial.

But just real nice cadence growth there and great feedback from physicians and patients, you know, post-surgery. I mean, if you're trying to poke at, you know, what's the breakdown gonna be about replace and repair? Listen, I think it's good to have options. I guess my view here is that I believe that probably safety is a key driver here, to start off with. And I think TriClip has shown a very strong, excellent safety record, both in clinical trials and real-world use. So I think that's gonna play a key role here in determining repair versus replace.

So I expect, I expect repair or TriClip, at least, to be the preferred option, unless the valves are too damaged, and then, obviously, replacement is, is, is the only remaining option. So, but there's a, there's a large pool of patients here. You know, you got 5 million people globally, 2 million people in the US. And, you know, it's gonna be an opportunity here that, we'll be generating more data, expand the indication of the product. So I think this is, this is easily a billion-dollar opportunity for us here, as we build, you know, as we build the capabilities and as we build, more clinical data.

Joshua Jennings (Analyst)

Excellent. Thank you.

Operator (participant)

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

Travis Steed (Analyst)

Hey, congrats on the good quarter. Maybe just, while we're on the pipeline, talk a little bit about AVEIR. It sounds like that product's going really well. And then I had a question on gross margins as well, trying to think about, is this the right pace to kind of get back to pre-COVID levels? And is that still the opportunity kind of longer term for gross margins?

Robert B. Ford (Chairman and CEO)

Yeah, I mean, I think AVEIR's done very well. I mean, we know—we all know the advantages it has over the competitive system, whether it's single and dual chamber, the longer lasting battery, the ability for replacement, retrievability, upgradeability. So I think it's done very well. From a single chamber perspective, I think we're now at about 50% share of the U.S. market. So that's been doing very well. It's performed... We started doing our dual chamber procedures towards the end of last year, and seeing a nice kind of ramp up over this first quarter here. Focus here really is really about—It's a completely different procedure, right?

I mean, if you think about how these, these devices have been implanted, this is probably the first time in, like, 30 years that you have, like, a real meaningful change on how this is done. So our focus here is really getting great clinical results, a real thoughtful approach here about opening new centers and training, and that's been working very well for us. You could see the impact on our growth rate, you know. I mean, historically, our CRM business has been relatively flat, you know, with some platforms going up, some platforms going down. So our goal here with this program was to get our CRM portfolio to at least be a contributor to growth, you know, mid-single digits, 6, 7%.

So these last couple of quarters, we've done 7.5%, and so AVEIR's been doing well, and it's gonna continue to get better as more and more physicians get trained, and we increase the amount of accounts. So I really like the cadence of how we're forecasting this business and the impact that it's gonna have on our CRM portfolio. What was your other question?

Travis Steed (Analyst)

Just on gross margins, kind of thinking about the path back to pre-COVID levels over the long term, and is this the right kind of cadence that you're—this year's cadence, the right way to think about that?

Robert B. Ford (Chairman and CEO)

Yeah. I mean, I think that's, that's, you know, that's a good cadence. You know, I think we're forecasting here about 70 basis points of improvement this year. Feel good about that. You know, I've, I've talked about this not being a question of if, just a question of when, so I think that's not a bad cadence. And we're gonna focus on the things that we can control, and the things that we can control are obviously our cost and, and our cost, cost teams and, and, and the teams that are working on improving gross margin. They're delivering great results here, while at the same time maintaining high service levels, you know, not running into back orders, et cetera.

But probably the biggest opportunity we have here, Travis, is just to expand the gross margin through portfolio mix, right? So when you have our medical device businesses growing at, you know, mid-teens consistently over the last, you know, whatever, four or five quarters, that has a real strong impact on our gross margin. So a lot of focus on what we can control, our gross margin, the cadence, you know, that's what we're targeting. So it's not really a question of if, it's just a question of when.

Travis Steed (Analyst)

Great. Thanks a lot, and congrats again.

Operator (participant)

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

Vijay Kumar (Analyst)

Hey, guys, thanks for taking my question. Robert, I had a two-part question. A lot of questions on pipeline, but I'm curious, you know, when people ask us on sustainability of growth, if you could elaborate on, you know, pipeline, what else is there, you know, when you look at the future, that gives us the confidence of Abbott sustaining its premium, premium growth within the med tech industry? My second part was on the financial modeling side. Looks like FX headwinds came in a little bit higher. Prior guidance is, you know, $0.20 headwind to EPS from FX. Did that increase? I'm just curious on... Because some questions on why the high end of the guidance was not raised. I suspect the FX headwinds increased. Thank you.

Robert B. Ford (Chairman and CEO)

Yeah, as I said, you know, there are certain challenges that still remain with us from January, and FX is one of them. I'll let Phil answer that one. On your question on pipeline, listen, I could spend a whole hour on this just going through the pipeline, but I guess I would bucket them into, like, three categories, Vijay. I'd say you got your current contributors, you know, Libre and Alinity, they still operate like pipeline projects, and products, right? We still got multiple innovations going through them. MitraClip, great familiarity. AVEIR, Navitor, TriClip, you know, Amulet, Protality, our Concussion test, I think it's got great opportunity, and CardioMEMS. I mean, these are all products that, you know, I would still characterize them as early innings.

Yeah, they're established, but they're still early innings, and they got a lot of growth rate there. You know, the second group of products I would call probably near-term future contributors. So think about it in the next, you know, 12-18 months, these products coming to market and starting to kind of generate revenue there. You know, our Lingo product, I'm very excited about that and bringing that to the U.S. and expanding that globally. You know, dual analyte sensor, our Volt system, Esprit, which is our drug-eluting bioabsorbable stent for below the knee. It'll be the first of its kind. We're developing a whole new Alinity system that will target a segment of the market that we currently don't participate in, and there'll be more to come on that.

And then just the great opportunity we have with biosimilars into the emerging markets and doing it in a very capital-efficient way, and bringing that and leveraging our position there. You know, that's our, you know, next 12- to 18-month kind of catalyst there. And then, you know, thinking about beyond 2026, I mean, we're working on a PFA RF catheter. You got leadless, another kind of leadless pacing system that we'll be launching. We have a second-generation Amulet. Excited about entering into the IVL market, you know, sometime in 2027. Coronary DCB, we're working on kind of new TAVR systems also that allow us to, you know, branch out into other segments.

We've got a whole plethora of new analytes in our biowearables market that will, you know, that will start to come out and have different applications in 2026. And then on top of that, all the clinical work that we're doing to expand indications, expand market, whether it's, you know, in TAVR, whether it's in LAA, whether it's in mitral. So we've got, I'd say, a real nice cadence here of products and pipeline, you know, beyond, you know, I'd say the next 12, 18 months. We're looking at this, you know, 2026, 2027, 2028, and I feel really excited about that. There's obviously more that we need to do and add, but I think the base here is, looks really good in terms of the pipeline.

And then I think your question on FX, Phil, you want to take that?

Philip P. Boudreau (EVP and CFO)

Yeah. So, I mentioned at the onset here, BJ, in Q1, we saw about a 2.9% headwind on sales growth, and we kind of, at current rates, anticipate something similar here in Q2. From a full year perspective, at the current rates, it's about a 2.5% headwind on the top line. That said, the kind of earnings guide that we have here is in line with the organic sales performance and drop-through to earnings on the increased midpoint on EPS guidance. Thanks, guys.

Operator (participant)

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

Joanne Wuensch (Analyst)

Good morning, and may I add my compliments and congratulations to the quarter? I have two questions. Put them right up front. The first one is on the concussion testing. I'd love to understand the go-to-market strategy for that, how you think about the financial benefit, impact, and all that kind of good stuff. But I think my second question is a little bit more big picture. You know, as you step back in a post-pandemic environment, a couple of years into the CEO seat, how do you think about taking Abbott sort of to the next level? I mean, we all sit here and take a look at an incredibly strong balance sheet. How do you put that cash to work?

Are these segments, divisions, ones you want to keep, or how do you think about adding to it? Thank you.

Robert B. Ford (Chairman and CEO)

Sure. On the point of care concussion test, I guess I'd summarize the opportunity here in twofold. I think there's a market conversion component to this, Joanne. You know, I mentioned there are 5 million ER visits to diagnose a concussion. You know, the number one method there to use is a CT scan. And I think there's an opportunity here to transform that and allow one to get a faster response, you know, in that emergency kind of emergency room visit, which is where the...

You know, which is where the i-STAT and the point-of-care team have, you know, already have good, a good position with some of our other blood gas, and other, and other assays that we provide to that segment. So I think this will just slide right into that team. And then the value proposition here is gonna be, okay, what, you know, what's the cost of the system, and can we, you know, can we bend that cost curve? I think we've shown a little bit how we think about things, Joanne.

If you look at Libre, if you look at Binax, if you look at how we think about pricing our products when it comes to market conversion, and the opportunities that we have there, and we'll be able to do it, at a, you know, at a nice return for our shareholders. So, so I think that's, that's an important part. The market expansion opportunity that we have, I think is, is gonna still require some work on the product. Right now, the product's approved whole blood, but it's a venous draw. If...

We're gonna be working on a capillary draw, and if you can then run this assay, you know, taking a sample from a finger stick, from a finger prick, then you can look at bringing that technology even closer to where the need for a rapid concussion test would be. You can just look at how many universities exist in this country, how many high schools exist in this country. You can do some multiplications there and say, "Okay, this is a, this is a great market creation, market expansion opportunity." So I think that that's how we're thinking about it commercially, conversion and creation/expansion.

There's some more work to be done in terms of the product and the claims and the, and the trials there, so this is a, this will be a, multiyear kind of program over here, where we'll start to see kind of nice growth in that, in that segment. And then your other question was about the portfolio and, and, and balance sheet, and, you know, do we like the four segments? And, and, you know, the answer to that is, yes, we like all the four segments. We, we feel that it gives us a real unique view into the healthcare system as a whole, you know, starting with nutrition, that's obviously the bedrock of good health. But then, you know, things happen, and you need to get a diagnosis.

And, you know, we've got a great diagnostic portfolio that we've been expanding on and building on to make sure that we can capitalize on all the different types of modalities and locations where people can get tested. And then, you know, once you know a physician knows what the problem is, then, you know, then they got to run through treatments, right? And we do that either through our medicines business or through our medical device business. So I think all four segments are super well aligned to, you know, the global demographics and trends in healthcare. And so we like that.

There's always opportunities to add, and we've shown that if there are areas that we feel that we can bring value in a combination, then, you know, as you mentioned, yeah, we've got a strong balance sheet and strategic flexibility to do that as long as, you know, we feel that we can, you know, we can add value to that asset. We felt like that about CSI. We felt like that about St. Jude. We felt like that about Alere. And those deals, you know, they obviously helped kind of reshape the company and accelerate our growth rates.

But I think that's predicated on us really believing that we can kind of bring value and, you know, we're not trying to fill, you know, some top line gap or, or, or some issues. So ROIC for us matters, profitability matters. So we've got opportunities, and we could be a little bit more selective to be able to add. But I like the four segments that we're in, and they have been well to shareholders, especially the long-term shareholders.

Joanne Wuensch (Analyst)

Thank you.

Operator (participant)

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

Matthew Miksic (Analyst)

Hey, good morning. Thanks for fitting me in, and congrats on the really strong quarter, particularly in Med Devices. So, Sorry, you're good. One question on Structural Heart. Robert, you talked a little bit about the portfolio, and, you know, the combination of, you know, the leading repair device in MitraClip, being a little bit more mature in the category of Structural Heart, but being kind of augmented by some of these new products, like most recently, obviously, TriClip.

If you could talk a little bit about, you know, sort of the momentum in those in the portfolio, as well as, you know, how much of the build-out of this portfolio is still, you know, coming organically or, you know, under review kind of strategically? I appreciate it.

Robert B. Ford (Chairman and CEO)

Sure. I mean, I didn't want my comments on MitraClip to be construed like, oh, that one there is slowing down, and, you know, we're relying on others to drive the growth. I mean, that wasn't the intent. If you look at MitraClip this quarter, it's grown high single digits. And if you look at the last five quarters, that's what it's been doing between high single digits, low double digits, and that's good. But we always had a view here that this was an attractive area of growth and an attractive area of medical need, and we wanted to be a leader here. So yeah, MitraClip, I guess we can call MitraClip the founding father of our Structural Heart portfolio.

But I think the team here has done an incredible job at bringing organic innovation into the portfolio. So if you look at our structural heart, I mean, we grew 13% today. MitraClip grew high single digits, but you know, it accounted for 3% of that growth. You know, the rest, the other 10% came from all the rest of the portfolio that's being built. So I think that, you know, you'll continue to see that. We'll continue to make investments in this business, continue to make investments in the pipeline.

I'd say right now, most of it is organic, whether it's, you know, innovating on LAA, innovating on our TAVR side, and all the clinical trial work that we're doing there. If there's an opportunity, inorganically, I just put that in the same bucket, you know, that I think I answered kind of Joanne's question here. If it makes sense and we can add it, we've got the flexibility to do it. But, the whole strategy here was to say, listen, we're going to build a multi-billion-dollar structural heart business that can sustainably grow double digits. And the way to do that is you can't be a, you know, you can't be a division of only one product.

I think the teams over the last four or five years have done a really good job at building that, and there's more opportunity. I'd say probably the one that we're looking at, and, is very exciting for us is, mitral replacement. You know, we've launched, you know, we launched our Tendyne product, which was more, a transapical system. Our Cephea system, is a transfemoral, transseptal, and, you know, feedback that we've seen from early implanters, early first in man, is that this is a great, great valve. So there's an opportunity there also. So I'd say mostly organic, but, you know, got the capacity for inorganic, if it makes sense. Thanks so much.

Mike Comilla (VP of Investor Relations)

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

Operator (participant)

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

Danielle Antalffy (Analyst)

Hey, good morning, everyone. Thanks so much for taking the question, and yes, congrats on a strong start to the year. Robert, we spent a lot of time talking about the durability of growth in the med tech business, so I don't want to get too greedy, but just following up on Joanne's question regarding, you know, you guys do have a strong balance sheet. Are there any areas—I guess, sort of how do you feel about the state of the med tech business today? And do you feel there are growth areas within med tech that maybe Abbott isn't participating in today, that Abbott could or should participate in today? And where are you looking beyond your current markets, if at all? Thanks so much. I'll just leave it to one.

Robert B. Ford (Chairman and CEO)

Sure. Yeah, I get the attempt for triangulation here and the multiple different ways, and I guess I'll sound a little bit boring here, in terms of how I talk about this. I've been public that, yeah, we are interested. We've looked, you know, we look at areas that we can add value to. I'd say probably the ones that have jumped out more at us in terms of us studying and looking are probably more in the medical device side than on the diagnostic side. We did look at, you know, a strategy for biosimilars for our medicines business, and that was a pretty capital-efficient way to do it.

So yeah, we're looking, we continue to study, but I'm not gonna sit here and telegraph exactly, you know, it's this, it's that. I think the key thing here is just I mean, look at our med tech business did this quarter, look what it did previous four quarters, and that allows me to be a little bit more selective, you know? Yeah, over the last couple of months, we've seen some fairly large transactions in the med tech space. Those seem to be attractive growth areas. I talked about us getting access to some early IVL technology with the CSI acquisition, so that's an important area for us to focus on.

But I don't feel that, you know, with our strong organic growth, that, you know, we need to go out and not pay attention to, like, other key financial metrics that, for us, are important, right? In terms of ROICs and others, because we've got that strong growth rate in med tech. You won't get me telegraphing here exactly, Danielle, you know, what specific segments we're looking at. What I can tell you is we have an active team. They study a lot. We look a lot.

We follow a lot, and, you know, if there's a moment that makes sense for us, and those segments continue to be interesting. Yeah, we've got the balance sheet and the track record to show that we can drive value out of these, out of these acquisitions. So, so I'll just leave it like that. Yes, we've got flexibility. That doesn't mean that we don't pay attention to other, other key financial kind of returns as we're looking at it. And I, and I, I feel that I can do that because, you know, we've got such a strong top-line growth and, and great pipeline and prospects. So,

Danielle Antalffy (Analyst)

Thank-

Robert B. Ford (Chairman and CEO)

So with that, I'll leave it-

Danielle Antalffy (Analyst)

Understood.

Robert B. Ford (Chairman and CEO)

I'll leave it... I'll leave it like that. I'll just close by saying, listen, we're very pleased with this very strong start to the year. We delivered another quarter of double-digit organic sales growth on the base business. The investments that we've made during all those years of COVID are generating real strong returns. The pipeline continues to be highly productive, as I've outlined. We've got, you know, clear visibility to a pipeline all the way out to 2027-2028. Obtained several new product approvals that are gonna help us, you know, accelerate our growth, in certain areas.

Typically don't raise guidance in the first quarter, but given the strong performance and the outlook on the remainder of the year, we felt comfortable doing that, and we're very well positioned to continue to sustainably deliver top-tier results. So with that, I'll wrap up and thank all of 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's conference call. A webcast replay of this call will be available after 11 A.M. Central Time today on Abbott's investor relations website at abbottinvestor.com. Thank you for joining us today.

Operator (participant)

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