Medtronic plc ($MDT)

All right. I think we can kick things off. But thank you all for joining. My name is Mike Kratky. I'm our Senior MedTech Analyst at Leerink and thrilled to be joined today by Medtronic's CFO, Thierry Pieton. So thanks so much for joining.

Yes. Thanks for having me.

You just passed the 1-year mark at Medtronic. We'd love to maybe kick it off by hearing from your perspective, how the business has evolved over the last year. And as you look out over the next 12 months, what gets you most excited?

Yes. Look, first of all, it's been an interesting 12 months. I mean we've had a lot of things going on between sort of accelerating some of the new product launches and some of the portfolio actions that we've taken that I'm sure we'll talk about, the IPO of MiniMed and we're going back on offense in M&A, and we've done a couple of things in the last 3 or 4 months. So it's been pretty busy. Look, I think the business has growing confidence. I think a lot of the work that has been done for several years in the past few years to build the portfolio and to reinforce some of the operating mechanisms in the team and to work on R&D on some of the innovations that we're launching now, it's starting to pay off. And I think there's a lot of excitement in the company. Performance has been improving from a top-line perspective over the last few quarters. And so I think it's confidence building, and I think the mood of the team is super positive and leaning forward.

Understood. And yes, talking about M&A, I mean, last 3, 4 months and even the last 3, 4 days, the Scientia acquisition. So maybe actually to kick off, would love to hear how you think about that business and why it might be a good fit for you guys?

Yes. So I think Scientia is the perfect example of what we want to do, right? So what it brings in -- so first of all, stroke is a massive condition out there. Millions of people have strokes every year. And time is really of the essence when you have a stroke. So every minute that you wait to fix the issue costs you millions of brain cells. So for us, having in the portfolio a very differentiated access guidewire is really critical. So we have good equipment for the thrombectomy piece of the business, so treating the blood clot or the hemorrhage, but we didn't have access. And I think now this is bridging that gap. And what we're seeing is because of how crucial it is to have access as quickly as possible, the access equipment actually dictates what equipment is going to be used afterwards to treat the problem, right? So for us, it generates a lot of synergy. They have a unique technology, which is a great balance between the stiffness of the catheter and the flexibility to access different tortuous parts of the brain as quickly as possible. And so it's -- yes, it's great to add that to the portfolio. And so they have their own base of customers. Some of the customers are common. We have our own -- they have their own. So there's going to be a commercial aspect to this. Our sales reps are going to be able to carry their product in addition to the existing range. And the financials look good. So for us, it's the exact type of example of deal that we want to be doing on a go-forward basis.

Perfect. And I might have more on M&A later, but I did want to jump in on your guidance and some of the most recent color during earnings that you provided. So I'm curious how you'd kind of characterize some of the top and bottom line growth expectations that you've set forth for next year and to what extent that kind of factors in the extra selling week?

Yes. So first, and I'm sure we'll go through some of these things in detail afterwards, but it starts with accelerated growth, right? And what we've said in the 3Q earnings call is that the organic growth that we're going to experience in '27 is going to be higher than the organic growth of '26. So right now, for '26 -- or fiscal year '26, we're calling 5.5%. So we should be north of that. And that's excluding the impact of the 53rd week. So it's true organic incremental growth. And I'm sure we'll go into the details, but it's on the back of CAS continuing to accelerate in the business because we're still in relatively early innings of the growth of that business, and we can drill into the details. But in addition to that, in the third quarter, we did 6%. In the fourth quarter, we'll do about 6% and the next generational growth drivers, so Ardian, Altaviva, Hugo haven't really kicked in yet. So what you'll see in fiscal year '27 is starting to see the impact of these other growth drivers, plus a whole bunch of innovation that we've got in the rest of the portfolio in peripheral vascular health, in neurovascular, et cetera, that are going to help as well. So we feel confident that we've got a great roadmap to continue to accelerate growth in '27 and beyond and again, in '27, excluding the impact of the 53rd week. If you look at the income statement, gross margins are getting better. So right now, the pressure that we've got from diabetes and CAS mix is going to get better. As that gets better, the progress that we're making operationally through pricing and cost out to improve gross margin is going to show up, right? And we'll get some leverage on the overhead part of the income statement. We'll keep investing in R&D, but we'll more than offset that with leverage on SG&A. So that's how operationally we're going to generate some leverage at the operating margin level. Below that, there are a few moving parts that I tried to explain in the Q3 earnings. We're going to have some dilution from the M&A activity that we've had. There is some dilution that's coming from the diabetes deal, in particular between the IPO and the split. And we'll have some carryover from the tariff effect going into '27. And we're going to use the 53rd week to offset part of that at the EPS level. And when all is said and done, net-net, we're committing to the high single-digit EPS growth for next year.

Very helpful. So maybe a good segue to the CAS business. Obviously, it has been a huge source of momentum for you, fifth straight quarter of accelerating organic CAS growth, close to 80% in fiscal 3Q. So would love to hear how you're thinking about the elevated growth rates for that business moving forward as you kind of lap some of these tougher comps, the durability of growth and how you can sustain some of that momentum?

Yes. So first, it's a growing market. So in Q3, the overall market was $13 billion, it grew 20%. We see it continue to grow in the high teens going into '27. So the pie is getting bigger. Within that pie, we've got a very unique offering now with the versatility that Sphere-9 brings. It's the only catheter that integrates the mapping, PFA and RF, which is a big deal for the physicians because in a lot of procedures, you don't know if PFA is going to be enough. And so having the security of being able to do the complete treatment without putting the catheter out and putting another one in is a big deal. And our data shows that in 50% or 60% of the procedures done with Sphere-9, there is actually utilization of both PFA and RF, right? So it's a big security. The physicians love it. And so that business is taking off. And it's -- again, it's in the early innings. We're still building the installed base of capital equipment. We're still working primarily on key accounts. So in the U.S., 70% of the business is with 30% of the accounts, and we're focused mainly on those. So we haven't really started going to the rest of the customer base at this stage. And even the key accounts, today, they have 1 or 2 pieces of equipment, and they want to get a second or a third or a fourth. So we feel there's a lot of runway. At the same time, we're expanding geographically to countries like Japan. We're expanding the indication to VT, and we're about to launch the next generation. So we just got CE Mark for Sphere-360 in Europe, and we started clinical trials in the U.S. So we should be able to launch that product sort of in 18 months from now. So yes, so we see continued increased growth from that business going forward. Obviously, the percentages at one point will not be the same because the base is growing bigger and bigger. But in absolute dollar values, it's becoming a bigger and bigger contributor to our growth, which means growth acceleration for Medtronic.

Understood. Yes, really, really helpful there. And I guess just digging in on specifically the PFA side within U.S. ablations. How do you think about where overall market penetration is today and where that could be, call it, in the next 12 to 24 months?

Yes. So I think today, it's in sort of 50% to 60%. And we think ultimately, it will get to 80%. So there's still a lot of margin for growth there.

Got it. And then maybe within that, you obviously talked about some of the Affera Sphere-9 dynamics has been gaining significant market share. So how do you think about that continuing over time? And what do you think Sphere-360 could ultimately mean for your business in terms of further market share?

Yes. So on Sphere-9, as I said, the reality is it's a very differentiated product today, and it's still a market where technology counts, right? So the physicians want the best technology, and that's what Sphere-9 is today. We know that the competition is working on competitive products. But from our -- from the data that we've got, it's still 1 or 2 years out. In the meanwhile, we're working on 360. 360 is a large tip rotation-free single-shot catheter. It's going to cut the procedure time even versus Sphere-9 by 2/3. So it's an incredible product from a speed of procedure perspective and in particular, adapted to more simple procedures, et cetera. So we're very excited to the incremental contribution that we're going to get from 360.

Understood. And maybe just one of the last ones on PFA. But as you think about potential bottlenecks in the market, whether it's capacity or otherwise, is there anything that you see as kind of a key point of sensitivity for market growth over the next 12 or so months?

For market growth, I don't know. But for our growth, manufacturing is not an issue at all. We've got plenty of capacity now to produce both the capital equipment and the catheters. The long pole in the tent, so to speak, is the mappers. And so we're hiring hundreds of mappers. But we're on track. And if you're a mapper today, part of your remuneration depends on the number of cases that you do. And so you typically want to be with Medtronic because that's where the growth is. So we're able to attract mappers. But again, that's -- if there was going to be a bottleneck at one point, that would be it. But today, we don't see that as a problem.

Got it. Very helpful. I'd love to shift to your renal denervation business. Could you share some of the early takeaways from the commercial launch so far and just the level of demand you've seen?

Yes. So first, so we look at the entire funnel, right? So from the very top, how many customers are interested in the procedure. And for that, we look at the number of clicks we've got on the Internet, and we look at every stage of the funnel down to the number of cases that we actually do. At the top of the funnel, the traction is tremendous. So in between Q2 and Q3, we went from 50,000 clicks on the website to 2.2 million, right? So there are a lot of people out there that have this problem and that are interested in this kind of life-changing procedure. So we're continuing to do some direct-to-consumer marketing to continue to build that. But really, it's all about creating the capacity to do the procedures down in the treatment centers. So we're opening accounts. We've opened more than 200 accounts. We're putting physicians in -- helping put them in Physician Finder so that people can be connected to them on the Internet. We've got more than 150 in Physician Finder today. But the -- again, the longest pole is getting the first -- getting the reimbursement done. And it's a new procedure. And so what we see is once a treatment center has done one procedure and successfully gotten reimbursement, then the second, the third, the fourth happen pretty quickly, but they don't want to take the risk of not getting reimbursed. So a lot of the resources that we're putting are dedicated to facilitate the reimbursement to help the customers get it as quickly as possible. But we're getting tons of traction. I mean the procedure volume is going up. The accounts are going up. The physicians are happy with it. The feedback that we're getting from the procedure is excellent. Competitively, we're very, very well positioned. So we're excited about it. But it's a new therapy, so it takes a little bit of time to build that market.

Yes. And I'd love to dig in on some of that. But have you quantified how large that business is today? As you think about your guidance and what you're factoring in for next year, generally, how large you expect it could be by the next 12 to 18 months?

So for Q4, it's still a relative -- a small number. Going into '27, it starts being noticeable, but it will take time. And we haven't given any specific guidance. And as it becomes a bigger business, we'll get more details, but it will start to be noticeable in fiscal year '27.

And then the other point you made is just on the competitive landscape and how you've been tracking above expectations there. So I'm curious what factors really seem to be driving that.

Yes. So look, so first of all, I think Medtronic, it's been a long time coming. So we have 15 years of clinical data. So we have far more data than any competitor out there. And what we're seeing is that we're the only OEM that provides a therapy that keeps having a positive impact after the procedure. So you do the procedure, hypertension goes down. And in the months afterwards, it keeps going down. And even up to 3 years afterwards, you keep seeing a benefit from having the procedure done with simplicity. What we're seeing is that's actually not the case with ultrasound. What we see is actually the reverse. You have an initial kick from a hypertension perspective when the procedure is done, but then it creeps back up. So for us, from a technology perspective, it's very encouraging. But we're not standing still. So we're developing radial access to make the procedure quicker. We're looking at using simplicity to do ablation in other organs to further increase the impact. So we want to lean forward and capture that business opportunity in the biggest way possible. It's 18 million patients in the U.S. with uncontrolled hypertension. So that's a massive pool.

Yes. Yes, no question. So maybe switching to TAVR. I mean this has maybe been one of the businesses that's been a little bit more variable. You talked about some of the competitive pressures as one of the main culprits recently. So how do you plan on navigating some of the recent challenges you've seen there? And what's the right way to think about the growth rate for your U.S. TAVR business moving forward?

Yes. So look, I think we had several good quarters in TAVR, in particular, in fiscal year '25. It was high single digit, and I think the business was performing well. I think it's been a bit slower in the last few quarters. And I think, candidly, we need to do better, right? So there's -- it's one of the performance areas that we need to continue to improve. I'll take a second to hit on the low-risk study on Evolut because there was some, obviously, news around that. For us, -- it's a valve that we stopped making a long time ago. Now we sell Evolut FX. It's the fourth iteration of products since the one that was concerned with the study. We've changed the procedure. There was a part of the procedure that -- where some physicians were using balloon expansion after the implant to expand the valve, which is part of the root cause of some of the issues that have been highlighted. And so for us, old procedure, old products, now we're on Evolut FX new procedure. So we're still positive about the performance of that valve. I think it's highly possible that we'll see some short-term disruption while people get the terms with the data. But long story short, this is a great space for us. Structural heart, generally speaking, is a great space. Medtronic has good market share, good reputation. We made the investment in Anteris recently because Anteris provides a great short valve that's balloon expandable. Balloon expandable is about 70% of the market now. So that's us showing that we want to go in that part of the business as well. And we're investing in mitral. We're investing in tricuspid. So again, we're committed to Structural Heart. It's a great franchise. It delivers great margins, and we need to go back up to the performance levels that we should be at.

Very helpful. Another area within cardio that I feel like maybe we got less color on sometimes is mechanical thrombectomy. We've seen that this has been a really attractive market. So I am curious how you think about your place in the market ahead of the Liberant full market release and the commercial strategy there?

Yes. So Liberant, for us, combined with Excipio, which is the mechanical thrombectomy catheter, brings the incremental benefit of having the suction. And so it's a key unlock for us from a product perspective. And the physicians are delighted to be able to have those 2 combined together. Medtronic also has a good reputation in this area. So we're excited about what Liberant brings actually both in the peripheral vascular health segment of the business and also in neurovascular. So it's sold by the 2 teams, and we're excited about that.

And maybe switching over to neuro. Altaviva, another product that has been clearly a big source of enthusiasm. So curious in terms of as that scales, what investors should be keeping an eye on to gauge how large this commercial opportunity could be for you?

Yes. So in a way, it's very similar with Ardian because you have to build awareness to the therapy on one end. And on the other end, you need to train the urologists and the physicians to do the procedure. It's a very simple one. And you also need to help them get the first reimbursement and get through the VAC process. And that's what we're seeing now. So we're sending clinical specialists and sales reps to the accounts and opening a lot of new accounts and helping them get the first reimbursement. And afterwards, we see the cases take off. And again, whereas Ardian is 18 million potential patients in the U.S. alone. For Altaviva, it's 16 million. 5 million of those 16 million are actually at a severity of the condition that they're already kind of applying or eligible for that type of procedure. So it's another massive, massive opportunity for us that will start being visible in '27 and will contribute significantly after that.

Understood. And it's a space that there's a few other potential products and competitors out there. So how do you think you'll be able to build market leadership here just based on the product profile that you have?

So look, the product is dramatically different from the competition. One, it's activated right away. So you don't need to come back several times in the weeks after the procedure to have it adjusted, et cetera. You come into the office, you have a small incision, it's inserted above the fascia. It takes a small amount of time, and then it's immediately effective, right? Second, the battery lasts 15 years. where the competition is like 2 to 3. So you don't have to remove the device for 15 years. You come once a year to the urologist, have your checkup, do the recharge of the battery by induction and you're good to go for a year, right? It's also MRI compatible, fully MRI compatible, which is a big deal because for the category of patients that have UUI, typically at one point, you're going to have an MRI exam done for something. And so the fact that you could do the full MRI without having to remove the device is actually a big deal, right? So yes, I mean, I think there's -- it's a very differentiated product on the market today. So good to have it in the portfolio.

Yes. Understood. And maybe another product that I feel like we're hearing more about recently is the Stealth Access platform. So, curious about where the differentiation comes from there and how large that could be really over the next kind of 2027 type time frame?

Yes. So 70% of procedures that are done in CST today are -- depend on the navigation element, right? So having the best navigation system is really key to being sticky with the customers. The CST team has been on this journey for several years now. And what we've seen is by integrating imaging, mapping and now robotic assistance with Stealth Access, you basically give much better patient outcomes, give a lot more information to the surgeon so that the procedure can be successful, help with the workflow of the hospital. And so it's made our CST business a lot more sticky, and I think you've seen it in the competitive dynamics. And we've been growing healthy mid-single digits for several years. The margins keep improving. And so Stealth Access takes that ecosystem formula to the next level, right? And so the AI is going to relieve the surgeons from a portion of the mental load that they have to deal with. The mapping is going to help them figure out the best way to actually carry out the procedure. And the robotic assistance is going to further improve their skills. So we're very excited about that product. And it's what's going to help us build the overall franchise. It's not just that product for that product, but it's also the impact it's going to have on the pull-through of the implants.

Yes. And maybe that's a good segue to your MedSurg business and talking about what Hugo might mean for that business, both stand-alone revenue contribution and then also kind of a balanced MedSurg, broader offering.

It's a great parallel. And I think Hugo brings to MedSurg exactly that what Stealth Access is bringing to CST. So it's the opportunity to provide an ecosystem that makes the outcomes and the workflow better for the hospital. Look, now Hugo is FDA approved in the U.S. It's a massive step because 90% of robotics are in the U.S. from a procedure perspective. We're the only OEM that can offer open surgery, laparoscopic, and robotically assisted. In an area where it tends to be partnerships. So people go with J&J or with Medtronic for the instrumentation, and they tend to stick to one of the two. So having that full offering is a big deal. And so now we've started commercializing Hugo in the U.S. We've done the first installations, and we did the first procedure just before we had the earnings release and the outcome was very positive. And look, it's a great step forward. There's a second player in that area now, and we're excited about that. But I want to stress that it's -- we want to be very successful with our key partners with Hugo. So it's not about flooding the market as quickly as possible. It's about picking the customers that want what Hugo brings to the table because Hugo is differentiated. And we want them to be super happy with the outcome so that we continue to build on the partnerships that we've established over time.

Understood. And just under 5 minutes remaining, but I would love to hear kind of the perspective, the latest thoughts on Diabetes business and MiniMed and what that might mean just in terms of financial implications for the business?

Yes. So look, we're happy that we successfully completed the first phase of the separation of MiniMed. We had committed that we would separate the business by the end of calendar year '26, and I think now we made a significant first step there. Obviously, when we launched the IPO, we didn't know that the conflict in the Middle East would erupt. And so it did create some market disruption. But at the end, we got a good deal. It's the second biggest MedTech IPO in history. And I think it's a testament to the turnaround that has been carried out in that business. It's got a great management team with Que as a leader. It's got a fantastic product roadmap ahead of it, which puts it in a position where it can really guarantee time in range for diabetic people in a very differentiated way. And so I think it's got a lot of runway. And we look forward to the second step of the transaction, which is the split. I think we should target sort of 6 months after the IPO, market conditions providing, and then we will have completely separated the business. It will be an accretive deal for Medtronic over time. The impact on '27 depends on the timing of the split because the EPS accretion that you get is based on the number of shares -- share reduction that you get. So when we do the split, we exchange Medtronic shares for MiniMed shares; that reduces the number of Medtronic shares and, therefore, increases the EPS. But the number of shares is calculated on a 13-month rolling average. So you only get the full impact of the accretion after 13 months. So in a way, the earlier we do it, the bigger impact we will see in '27. But at the end, this is about the strategic move that we're making, right? It will be accretive, but more importantly, it puts both Medtronic RemainCo and MiniMed in a position where both businesses will have their own capital allocation, their own investors, et cetera, and are poised to be successful. So yes, I think we're on track, and we're happy to see it move.

Understood. Well, we started the conversation on M&A, and I'd maybe love to wrap up there. So in terms of how you think about your appetite for business development, the size of the deals that you might be looking at moving forward -- is yesterday's Scientia deal a good way to think about what you might be interested in the near-term, what a larger deal might look like for you?

Yes. So as I said, Scientia is the perfect example. There's complementarity from a product perspective; from a commercial standpoint, we can help at one point, scale the manufacturing. And so there are a lot of synergies. And so that's the poster child of what we would be doing. Another example would be Affera. We had PulseSelect that was an organic development on one side and Affera, which was an acquisition, gave us 2 shots on goal. It turns out both of them are successful, which is great. And so that's what we're looking for. Anything that can help us create ecosystems in our portfolio that make our products more sticky and accelerate our WAMGR, right? So that's kind of the -- those are the criteria for the type of business. And then from a financial perspective, we have high thresholds from a return perspective. And from a size standpoint, we're looking at medium-sized tuck-in. So basically kind of $3 billion to $4 billion max in terms of deal size, but around $1 billion to $3 billion is probably the sweet spot. But we'll also do venture investments for more upstream type of ventures, et cetera. But we're going back on offense, and it's great to see.

Understood. Well, certainly a lot to be excited about. I know we're up on time. Thank you so much for joining us, and thanks all for coming.

Yes. Thanks, everyone. Thank you.