Medtronic plc (MDT) Earnings Call Transcript & Summary

Good afternoon, everyone. Really happy to welcome our next speaker and company. We have Geoff Martha, the CEO of Medtronic. Geoff will do a presentation followed by some Q&A. Geoff?

All right. Okay. Thanks, Robbie, for the introduction. Let me see here, let me get the clicker. So first of all, there will be some forward-looking statements in my comments so I'd urge you to read the slide. And this slide and the whole deck will be available on our website. So first, I'm looking forward to the discussion. We've got a lot of momentum right now at Medtronic, and I'm excited to share that with you today. Like what we're saying is we're in the moment as we sit here today, a lot of exciting innovation. That's going to be the bulk of the presentation is talking about that momentum. And it's created a tailwind for the company that we haven't had in a long time because these are growth drivers across some of the most exciting markets in med tech. And this is all underpinned by really a much stronger foundation that's ensuring resiliency of our performance and really starting to deliver earnings power. You've seen over the last 8 quarters, we've had much more consistent revenue growth. And now we're starting to show -- we signaled in our guidance in the back half of the year, our fiscal year, right, we're in our Q3, high single-digit earnings growth. So you're starting to see that as well. And then in addition to that, we're a really strong believer in portfolio management and decisive capital allocation that's going to create long-term shareholder value, really setting up the company to make sure our portfolio can deliver, assuming good execution on this financial algorithm of mid-single-digit-plus revenue growth, strong leverage down the P&L, and strong cash flow to add to our dividend to get to that double-digit return. But before we jump into the growth drivers, I just want to remind everybody of some of the changes we've made over the last several years that have positioned us for this moment and for success. It started about 5 years ago with a renewed commitment to innovation, which is the lifeblood of the company. But beyond that, we made another -- a number of other changes to the company: streamlined our operating model, put a lot of different incentives in place to drive a more performance-driven culture. We've brought in new leadership from outside, the industry outside the company, in many cases, to help with new capabilities that we needed, but in other cases, really to help also driving that culture change of being an end company, mission-driven, which everyone knows Medtronic is as well as performance driven. And then we talked about capital allocation in a second, really allocating our resources, capital and human resources to the highest growth opportunities in med tech and then to drive that growth. And then centralized, one of the big things we're doing to drive the earnings power is we centralized our global operations and supply chain to drive, like I said, resiliency in our operations but also drive a lot of cost savings that we'll talk about that's contributing to this leveraged earnings growth. But let's jump right into the growth drivers. I'll start with our Cardiac Ablation Solutions business or ablation for AFib. Pulsed field ablation, we've received a lot of questions around this, a lot of discussion at this conference around that. Obviously, it's a $9 billion segment, growing mid-teens with a really strong growth runway in front of it. I want to start by reiterating what I said on our second quarter earnings call is that this Q3 for us, we expect strong double-digit growth in our CAS business. We're super excited about this. A lot of that is -- or most -- that is based on the scaling of our PulseSelect technology, which is our single-shot PFA catheter organic program that is really starting to get scale. Look, the more physicians use this technology, the more that they like it. It's a good catheter. And then on top of that, we've got -- we're now launching our Affera technology, which I'll get to in a second. And both of these are, in addition to being very competitive, the safest catheters out there. We've got really strong safety data on both of these. And as we've seen over the last week, safety here really matters. Now let's jump into a little bit more on Affera here. You can see that's just an overwhelming customer response and physician demand. You can see some of the quotes here. I'm not going to read every one of them. But suffice it to say, there's a lot of demand for this. Where we are right now is we're significantly expanding our manufacturing capability to handle this demand. We're hiring mappers ahead of account activation. Some of these mappers are coming from competition. Some are coming new to the mapping world. Our mapping system is relatively intuitive and the learning curve for mappers is not that challenging. So that's where we're getting our mappers. And look, we're targeting the high-growth centers. Medtronic has always been strong in the EP space but most of it has been cardiac rhythm. And so when it comes to the ablation world, we've been in a little bit more niche spot with cryo, but now we're in these -- with this new technology lineup, we've made a lot of new friends in the EP world and we're in the high-volume centers. And in terms of any concerns about acquisition of this, we're not experiencing that. We're seeing, between innovative contracting models and other capital acquisition models, we're making acquisition of the capital relatively seamless for customers, which is really driving. I'm sure we'll have a lot more on this in the Q&A but we're off and running in this exciting space. Next, I want to hit Structural Heart. This is an area that I think there are some skeptics out there. It's a $6 billion-plus market growing high single digits. There are some skeptics out there who questioned our ability to grow our TAVR franchise as new entrants came into the market. But we've shored up this business with new products, new data and better sales execution. And we're seeing strong commercial traction of our latest-generation Evolut FX+ valve, which is designed to facilitate lifetime management and easier coronary access. So engaging with customers on this new valve also allows us to reiterate the benefits of our technology as well as the clinical performance of our low risk and our SMART trials. SMART demonstrated non-inferiority -- noninferior clinical outcomes and superior valve performance in patients with small annuli, many of them who are women, which is very underrepresented in clinical research. And we expect 2-year data from the SMART trial later this year. And we remain committed to data transparency and patient outcomes, which is not always done in this space. And this is really helping us and it's been a real -- will continue to be a real strong growth driver for us. I want to shift to hypertension. Our simplicity blood pressure procedure is poised to transform hypertension management, and it's a large opportunity that's right in front of us, and I really mean right in front of us. It's -- very excited to share some breaking news from like 2 hours ago that CMS has just announced that it's opened a national coverage analysis for Symplicity, which this is huge news, huge news for patients, and it marks a pivotal development in our efforts to support access to this innovative procedure. We've made a tremendous amount of progress over the last couple of years with Medicare coding and payment for Symplicity already in place. Now we're really excited to see this final piece of the puzzle, which is coverage snap into place and now being addressed. And so we're -- look, we're ready to commercialize on the opportunity in front of us. And let's talk about that opportunity. The opportunity for Symplicity, like I said, is massive. Hypertension is a global health challenge affecting over 1 billion patients worldwide. Just 1% penetration, 1% penetration of this target market represents a $1 billion market. Half of all heart disease and stroke-related deaths are caused by hypertension, leading to $0.5 trillion in direct costs in health care systems around the world, over $200 trillion just here in the United States. And if you have hypertension, it's likely that you don't have it under control. 75% of hypertensive patients do not have their blood pressure under control, and 50% of them stop taking their meds within 1 year. So here we come with Symplicity. It's a safe, onetime, a very tolerable procedure. It's always on and it's going to drive meaningful benefits to patients. And you can see on the slide here, we've got a couple of different cuts at the market. And how you cut the size of the market, it is just massive. So we are really excited about this. This has been over 15 years in the making. I want to congratulate all the Medtronic team that's been working on this and knows at the FDA and CMS who are really -- this is going to change the game. Another area that we have some news that we just shared today is our Neuromodulation business. This is a -- this has been a newer growth driver for us even though the business has been around a long time. We pioneered it. We've got a lot of momentum as we sit here today. We're in a strong innovation cycle, which enables even more innovation in the future. We're working from a real position of strength and we expect to remain the category leader. This is an area where the investments we've made over the past several years in sensing technology in the brain and the nervous system are now paying off. Sensing and closed-loop technology is becoming foundational for the neuromod space. And anybody that tells you different, they don't know what they're talking about. It's reinvigorating this category and expanding this very attractive $5 billion segment, which is growing mid-single digits. And on top of that, we're going to -- it's going to grow the market but it's also going to grow our share and expand our lead here. We're transforming the treatment of chronic pain as well as part of this and developing solutions for patients with movement disorders like Parkinson's, essential tremor, dystonia and epilepsy. And we have several catalysts coming in the near -- in the future. So we're pleased to announce today that we just received CE Mark for what we call Adaptive DBS, and we're already submitting -- we've already submitted to the FDA. So this has been categorized as a brain-computer interface technology. And it's the world's first complete closed-loop DCS system with real-time self-adjusting brain stimulation for patients with Parkinson's disease, so very exciting. There are features now available -- these features are now available on our Percept neuromodulation system, which means new and existing patients that have Percept that have Parkinson's will have access to this groundbreaking technology. So it's kind of like a Tesla. You can download the new firmware and automatically get the new therapy. And from a brain-computer interface perspective, we already have 40,000 patients on this, which makes it, by orders of magnitude, the largest -- the most scaled BCI technology in the world. Okay. Next, let's talk about diabetes. You've seen us turn around this business over the last couple of years, as it's grown above our corporate average for the past 6 quarters, and we don't see this stopping anytime soon. We're well positioned in this $16 billion-plus market growing double digits, where as you can see on the left-hand side of the slide here, smart dosing is expected to dominate by the end of the decade as CGM alone is just not sufficient for this patient population. We remain the only company investing in a comprehensive ecosystem of differentiated technology for intensive insulin patients that takes on more of the work of the diabetes management, takes it off their plates. And these investments have brought several new innovations to market like our Simplera sensor, which is half the size and much easier to apply than our previous sensor and is driving growth in international markets. And there's more to come in the near term with our -- starting with our CGM portfolio refresh with Simplera, Simplera Sync and, of course, our Abbott partnership. But beyond the tech itself and expansion of this tech ecosystem, we have several expanded labeling opportunities on the horizon, including type 2, again, we're mainly a type 1 business, moving into type 2, which represents a meaningful driver for this category. And all of this is strengthened by ADA guidelines for AID as the preferred insulin delivery method to improve outcomes for people with type 1. These guidelines will rapidly move the therapy to a standard of care. So combining these activities alongside our pipeline investments, all supported by our strategy to be #1 in this fast-growing AID and Smart MDI space with a technology ecosystem that not only focuses on achieving better control but also doing it with less burden. So beyond some of these high-growth segments, we've got a lot of other innovation coming as well, and I want to make you aware of some of it. So for -- you can see on this slide, I'm not going to go into too much detail, on Structural Heart, we have our Intrepid valve for mitral and tricuspid repair. We have more in the cardiac ablation space with our Sphere-360 PFA catheter for single-shot ablation to treat paroxysmal AFib. We're looking to expand our TAVR indication into the moderate aortic stenosis space. We recently -- this is something I don't know many know about, we recently acquired an articulating catheter technology for both robotic and nonrobotic applications. In the pelvic health, we have our tibial system for overactive bladder coming. This is an opportunity to double the size of this $700 million, $800 million business for us over the next couple of years. And then in diabetes, getting back to diabetes, we have next-gen AID systems, including a patch and pump, new pump modalities to combine with our next-gen sensor. So this is just a small sample of our overall pipeline, and there's others that we haven't shared yet. But I'm confident that we have a pipeline to sustain our growth over the long term. But underpinning these high-growth areas, I do want to touch quickly on our big businesses that really serve as the base of our business, the underpinnings of the company. And there's some real innovation going on here: Cardiac Rhythm Management, Micra leadless platform continues to do well as it expands geographically, new indications and some new tech coming there. Our EV-ICD is still in the early stages of launch. So a lot going on in Cardiac Rhythm. In our CST business, our Spine business, I could talk about this all day, but we shifted this whole market to a technology-based market and where you have to have technology chops and you have to have financial capabilities and scale here. We have a 10,000-unit installation, and it's really changing the competitive dynamics of this market and driving really strong growth we haven't seen in Spine in decades. And then finally in surgery, we continue to make, and I'm sure there'll be questions on this as well in the Q&A, a lot of progress on our Hugo platform, and we're confident in our positioning to become a strong #2 player in the surgical robotic space. Usually, we're targeting #1, but right now, we'll just target #2 here. And I think that will be pretty good here over the immediate term. Our installed base globally is increasing. We're currently in 25 countries. Our year-over-year procedure volume for Hugo has doubled. There's about 170 papers out there from different KOLs that compare our system favorably to Intuitive. Our same-store sales, if you were, so where our Hugo accounts are, they're growing the use of Hugo year-over-year. It increased about 50% year-over-year so a lot of progress there. In the U.S., we plan to file our urology submission with the FDA this calendar quarter. Meanwhile, enrollment in our next 2 U.S. indications, hernia and gynecology continue to enroll very quickly. And we're leveraging data and AI capabilities in intraoperative solutions with touch surgery that will continue to advance this technology. We're also making progress on bringing our advanced surgical technologies to Hugo with ICG, that's imaging or visualization technology. And while we look to our market-leading LigaSure vessel sealing technology this calendar year. So as we look across the surgical landscape, our strength in instrumentation, our knowledge and partnerships in the industry and training physician, combined with our Hugo platform, makes us really the only company that can offer a comprehensive solutions across open, minimally invasive, and robotic-assisted surgery. So what you have here to kind of sum it up, you got this fortified base of Medtronic, our big businesses, our CRM, our Spine business, TAVR, E&T and others that are fortified with innovation and growing well. And then we're stacking growth drivers on top of it. In the moment, we talked about Diabetes, Neuromodulation, Cardiac Ablation Solutions, very, very soon, hypertension here with this news around reimbursement coming. And then out into the future, I'll call it, intermediate term, I mentioned the tibial platform that we've got coming in the overactive bladder space. We just talked about soft tissue robotics, and we also mentioned mitral and tricuspid. So we're well positioned in the moment, tomorrow, and out into the future with innovation. But I want to shift to how that innovation is also going to turn into leveraged earnings growth and improving the earnings power of the company. This is equally important and something that we haven't pulled all together here for a couple of years. Organization is extremely focused on improving our margins and the direction of travel here is very positive. This quarter, we're expecting sequential gross margin improvement, and we're expecting the gains this quarter and next quarter. And in next -- in the balance of the fiscal year, we've highlighted that we're going to hit a high single-digit EPS growth. And it's really on the back of a lot of pricing discipline, especially on new technology, holding down our SG&A cost, especially as the company is growing, we don't have to grow the SG&A using technology and other things, and then driving COGS productivity under our newly centralized global operations supply chain organization, driving a lot of COGS productivity that we haven't seen before. And this is something that will go out to the future. This slide here, I'm not going to go through all of it, highlights some of the programs under our COGS efficiency work that's really driving the -- helping to drive the earnings power of the company, like I said, now and into the future. And I want to wrap up with capital allocation and portfolio management. Another way that we expect to create significant shareholder value is through our decisive capital allocation and active portfolio activities. With capital allocation, we continue to invest and drive future profitable growth while also returning capital to shareholders. With our growth investments, we have a high focus on organic R&D, having spent almost $2.7 billion last year and continuing to grow that number. We also continue to focus on supplementing our organic innovation with tuck-in M&A. Tuck-in M&A is a priority, and we're on the hunt for tuck-in M&A that leverage our existing businesses and enhance -- that will also enhance our growth and our margin profile. And we continue to balance investments for the future while providing strong returns to our shareholders through our strong and growing dividend and opportunistic share repurchases. On portfolio management, this remains an incredibly important lever and an area where we've been devoting a lot of time both as a management team and as a Board. I know there's speculation on this topic when it comes to Medtronic and the investment community. And while I'm not going to get into specifics, I will say that we're constantly evaluating our portfolio at the business level, at the product line level, at the -- within our geographies to make sure that we're optimally aligned to deliver on our long-term strategic and our financial objectives. So at the end of the day, our North Star through all this is to optimize our shareholder value. So just to kind of wrap, as you saw today, we're in the moment on some major product launches, and we have a strong pipeline in important med tech growth markets. We're stacking these growth drivers on top of one another. And now we're focused on driving earnings power, enabled by the foundation I talked about and better execution on programs that leverage our scale to drive these cost savings. And third, active portfolio management and capital allocation remain important levers that we're focused on to deliver the long-term strategic and financial performance objectives. So let me leave you with this. We have a ton of momentum. We're deeply committed to creating strategic long-term value for our shareholders, and we're super excited about where we are right now and into the future. And so with that, Robbie, I'll turn it back to you for Q&A, and I've got a number of our colleagues who I'm going to invite up on to the stage, our Interim CFO, Gary Corona; and then our 4 portfolio leaders, Que, Mike, Sean and Brett. Yes, I guess I'll stay here.

You gave me a lot to work with here, but let's start with the announcement that just hit a little while ago, the national coverage analysis for Spyral and renal denervation. And it looks like it's a pretty formal analysis with set time lines that ends up in October or earlier potentially within NCD. Is that the way for people to think about it?

Sure. Maybe I'll have Sean answer that question, but I'll say just as context, we've been working for years to set up. Payment is a big part of this so we've set up the billing capabilities. We've set up the payment capabilities with the outpatient numbers just going into effect January 1, but this coverage decision is big. So you want to walk through that, Sean?

Yes, thanks. So what's great about this is this gets you on the pathway to national coverage determination, which gives you immediate coverage for all Medicare or Medicare Advantage patients. And it's typically what the commercial payers then follow as determinations they make. Unlike a kind of normal pathway for NCD, you kind of go into [ some bit ] and it's uncertain about things. But we follow the TCET pilot framework here, which puts, as you said, Robbie, those definitive dates out there. When? We'll be in a 30-day calendar day comment period right now, public comment period. By about the middle of July, that's when they'll determine the evidence that's required. This is coverage with evidence development. And then it gets locked down with a target date for implementation into that 9-month time frame, which is pretty typical. It could happen sooner but it's all out there. I think the clarity of what's coming when is what's really important, and we're obviously very super excited about this.

So I know you'd been holding off on trying to prelaunch or educate and build the referral networks until there was more clarity on reimbursement. So now that there's a lot more clarity, are you going to go out and effectively -- it's because it's an approved product so you can detail on it. Are you going to go out there and aggressively start building the referral networks in the infrastructure because there will be a heavy lift ahead of time? Or is it still something you're waiting until later in the year?

Great question. Yes, of course, we're going to continue to build the footprint of centers that can offer this, right? So there's a lot of physician training, getting their hypertension programs set up and going. But when reimbursement comes, that's when you start to really directly reach out to the referral networks and patients themselves directly and you do it in that order. You got to make sure you got a -- you don't want to frustrate anybody, that you've got payment available, you've got trained capable physicians ready to do the procedure. So it's all very planned out sequentially. We've been opening accounts. We're getting payments today under the TPT, which just launched on the 1st of January for Medicare population. And that's obviously going to inflect once we get the formal coverage in place.

We all want to try and translate that into numbers, and obviously, you're building a new market here. There's another competitor out there, but it's still something that's, in my view and I feel like you've used these words before, it's going to be a heavy lift to educate everyone. And despite the huge opportunity, it's still a new procedure to treat something that's been mostly drugs in the past. So how should we think about once the NCD hits in October, how fast can this really ramp?

Yes. Well, it's hard to know. I mean we're going to know exactly what the indication is for reimbursement, what's paid for. But suffice to say, yes, it's a new procedure but we've got a lot of evidence. It's got an unmatched safety profile. We've got durable treatments that they'll last out to, I think the data is out as long as 9 years and that drop in blood pressure, if anything, gets better over time. So the value proposition is really compelling. The awareness of that is what we have to work on, right? So that -- particularly in the referral channel and for patients directly. We've done also formal studies with patients to say, would you rather take one more drug or have this procedure with unreasonably high, like complication rates, which don't exist? These are very, very safe procedures. And they would opt something like 30% to 40% of the time to have a procedure rather than taking just one more drug. So we think it's a very strong value proposition. But you're right, we've got a story to tell and we will. That's a lot easier when you have the reimbursement hurdle knocked down.

Right. Geoff, maybe for you. I heard you mention the word tuck-in several times. I saw you used the word, renewed focus. We've seen some of your competitors even in 2025 so far pull the trigger on some tuck-in M&A. We haven't seen Medtronic anything more than some pretty small deals over the past 5 or so years. How should we be thinking about what constitutes the tuck-in and what are some of the ideal qualities in a tuck-in you're really focused on?

Yes. I mean, look, we've been busy on a lot of different things as you saw in here. And I do think we can step up, be a little more aggressive on some of the tuck-in M&A. And for us, that means areas that we're either in, so shoring up a product gap that we may have in an area that we're in, or adding an adjacency to an existing area. Tuck-in dollar size, a couple of billion dollars, an ideal one would be something that is closer to revenue. So like the last 2 meaningful ones we did, an ENT deal called Intersect ENT. It was already in the market, had about $100 million. It's fast-growing. We tucked it into our ENT business. This is a $1 billion business for us with high growth, and that's the best return on capital in the company. So that was a really good one for us, almost like no dilution. It was immediately accretive. And then Affera. Here, you're going into an area, this is one of our pulsed field ablation products. It wasn't on the market but we quickly got approval on the market relatively quickly. So again, not overly dilutive and a lot of the risk could burn down. So those are kind of ideal ones for us. I mean those are all -- both about $1 billion. Could it go to $2 billion or $3 billion? It's less about that. I don't think it's going to be $10 billion we're looking for. But it's in that range, in areas that we're in, where we have strength, adjacencies around it and the closer to cash flow, the closer to revenue, the better.

Got it. Hard not to ask about EP and pulsed field ablation. I think that was your first slide in the product deck. You're calling for double-digit growth in the fiscal third quarter.

Fiscal third quarter, yes.

Maybe just give us an update on Sphere-9 and the Affera system, where you are in terms of manufacturing capacity, time lines for a full launch and the early feedback and the launch so far?

Well, I'll let Sean answer that one but I'll start with this. I'll start with in this PFA or just the whole AFib space. Like I said, we were fairly -- it was a nice business. Cryo, it's a nice business but it's fairly niche. And now we're off into these big, high-volume centers. And I would expect strong growth going forward when you look at -- so I get a lot of questions around Affera launch, but between PulseSelect and Affera, we're just going to grow from here. And if you want to get specifics on the Affera, we just got a new factory approved. But why don't you -- Sean, why don't you give them?

Yes, sure. So I think first and foremost, the launch has been exceptionally well received. Huge enthusiasm and we get it in the hands of physicians, they want more and more and more. So being responsive to the demand, we've added capacity. As Geoff said, we just got a new manufacturing facility, additional 1 in Galway, Ireland approved. That's one of our marquee factories, really high quality, excellent volume coming out of there. So that's going to help a whole lot. And the other part of the capacity is making sure you have your field personnel hired. And as Geoff said in his presentation, we've been hiring ahead of opening account subs so we're ready to go. Once we get into these procedure rooms, the procedures are going to go forward. So things are getting better and better. But it's a huge market. It's going to take a long time to fully launch. It's not a 1-day event. We're going to continue to build this and it's going to be a durable growth driver for us.