Edwards Lifesciences Corporation ($EW)

All right. Thanks, everybody, for joining us this morning. Very pleased to have with us at our conference, Scott Ullem from Edwards Life Sciences CFO, long-time CFO, not to make a big deal out of it, but sort of coming around the final lap in the role. So exciting times ahead, but -- so appreciate having worked with you around the name for all these years.

Yes. Likewise, thanks, Matt. And I'm also here with 2 colleagues of mine. Gerianne Sarte, who is taking over as Head of Investor Relations at Edwards Lifesciences next month; and Sydney Bailey, who is an experienced member of our Investor Relations team, and has recently returned from leave. So we'll both be here all day. Thanks, everyone, for your interest in Edwards.

Yes, you bet. So maybe to start off, we were just chatting a minute ago about some of the takeaways from CRT. I don't think in the 23.5 minutes that we have, we'll have a chance to get into those in detail. But at a higher level, one of the questions that we get around Edwards is sustainable is the ability to deliver on this sort of double digits sustainable growth and the components of that. So maybe how -- at a high level, when you get that question, if you get that question, how do you piece together sort of the established, if you will, TAVR business and the opportunities there, plus the faster-growing emerging businesses under TMTT and elsewhere?

Yes. So it's not just a question that we respond to, it's actually our strategy, right? We've designed our company strategy to generate distinguished organic sales growth. And we do it through principally investing in these technologies and platforms that are differentiated and that offer therapies to populations of patients that are large in size. And of course, they fall into a couple of categories. TAVR has been really the cornerstone of our growth for decades now at Edwards Life Sciences and continues to be a big driver of innovation and growth for the company. And I know we want to talk about this more during the session. Transcatheter mitral and tricuspid therapies is a similar strategy of TAVR in that we're bringing a minimally invasive solution for patients suffering from a structural heart disease and doing it in a way that is distinguished because it's supported by scientific evidence of the safety and efficacy of these therapies. And then surgical is our long-term flagship business at Edwards Life Sciences where we continue to innovate both for mitral and aortic valves and now soon tricuspid surgical valve replacement as well. And so the combination of those 3 businesses plus new initiatives in structural heart like structural heart failure therapies is really what gives us confidence in our ability to generate double-digit top line growth constant currency on average annually.

Okay. So maybe one follow-up on that is the contribution from TMTT started obviously to growing a lot faster. EVOQUE is kind of entering the early to middle innings of growth maybe. But when does that become the bigger dollar contributor to growth? Because I think that's for some time has been kind of, I don't want to call it the dream, but the long-term strategy knowing that TAVR wouldn't always grow in the teens or wherever it was going several years ago as that kind of matured that mitral and tricuspid would start taking the helm. So when on a dollar basis, is that 2 years away? Is that 3 years away? What could you tell us?

Yes. Well, we haven't really laid out the year-by-year dollar contribution to growth, but our long-term guidance is for TMTT to grow to $2 billion in revenues in 2030 and to continue to grow thereafter. And for TAVR to grow mid-single digits, mid- to high single digits over time on average annually off of its current base. So you can run different scenarios what that looks like. But I think more importantly, suffice it to say, TMTT is representing an increasing component of Edwards' consolidated growth rate. So the business was over $500 million in 2025. We expect it to be $740 million to $780 million in size in 2026. And then continuing to grow beyond that, obviously, to that $2 billion number in 2030. And so it's a combination of TAVR growing mid- to high single digits, TMTT continuing at this growth rate, 35% to 45% in 2026. And then surgical continuing to perform as well that contribute to this expectation of double-digit 10%-ish growth over time.

Okay. And so we might look at TMTT and say, well, okay, it's growing faster and then it's growing a little less fast and a little less fast. But the reality is under TMTT you're actually rolling on sort of growth drivers. So we're in the early innings with tricuspid and with mitral repair, you could say or in mitral repair in the market for a couple of years now and taking share from the market leader in the U.S. But then we have mitral this year, replacement and then tricuspid replacement. So maybe just getting started with mitral replacement, maybe talk a little bit about how that might be similar, how that might be different from what you've seen over the past couple of years in tricuspid replacement?

Sure. But just to acknowledge the important point you made, Matt, this is the first time when this vision that we had long ago has really presented itself where we've got repair and replacement therapies for patients with both mitral or tricuspid regurgitation. So we -- this is -- you've followed us for so long. You know this is a longtime dream of ours, and we started with this transcatheter edge-to-edge repair technology in the form of our PASCAL therapy. And now we've got PASCAL for mitral and tricuspid, EVOQUE for tricuspid and SAPIEN M3 for mitral valve replacement. And that combination of therapies is a really powerful element of our strategy because it gives physicians options when they're trying to treat patients who historically have had only one option, which is surgery. And a lot of patients are not eligible for surgery or not recommended for surgery by their physicians for these diseases. So to your question about mitral, SAPIEN M3 is the first transcatheter transfemoral replacement device for patients suffering from mitral regurgitation. We've learned a lot about the disease over the years from our PASCAL experience. But SAPIEN M3 offers this unique combination of addressing the complex anatomy of the mitral valve with a coil, but also using a proven multigeneration SAPIEN valve to actually perform the work of the native mitral valve that's being replaced. And so it's -- it's a very sophisticated, safe and effective procedure that we're excited. Now we have approval to offer in multiple different geographies, okay?

So training ramp, I mean there's a couple of differences, right? So one is, as you got into early EVOQUE, there was -- you obviously want to be engaged in these cases completely engaged because it's a new platform. And so I guess, similar in that way, maybe a little bit different in the sense that there are some other therapies that are treating those patients in mitral now. There's repair, which everyone is -- whether it's your system or Abbott system, folks are comfortable with the safety profile. And then there's surgical repair, which is also pretty entrenched. So fair to say just a little bit different in those regards, maybe like in the beginning, a tighter lane for finding the patients with M3 versus more of an open field in tricuspid. Is that a fair way to characterize it?

Well, maybe, I guess what I'd add to your description, though, Matt, is patients are eligible for different types of therapeutic interventions. And a patient who may be eligible and recommended for a PASCAL procedure may not be recommended or eligible for a SAPIEN M3 procedure and vice versa. And it's the reason why this toolkit approach that we've taken is so important. It's not okay just to have one device that you try to make for all patients because patients anatomies, especially for patients with mitral regurgitation are complex and different. Patients may have a challenge with the chordae, with the leaflets of the mitral valve, the left ventricle may be diseased. And all these different elements of the way these diseases manifest themselves inform the right treatment alternative. That's the reason why we have both the repair and replacement solution.

Okay. No, that's fair. So maybe some of the new growth opportunities. These are a little bit. I mean, and we throw in there also like in a valve for mitral, which is a couple of cycles away of joining M3 in that space. But maybe talk a little bit about the heart failure, structural heart opportunity when we can start to see that ramp when investors will notice some of those programs and then given the opportunity in AR, how that starts to play out with J-Valve?

Sure. So first on heart failure therapies. We decided -- as we learned more about these different diseases, especially mitral and tricuspid regurgitation that there was overlap between the structural heart patients we have been treating and patients suffering from structural heart failure in a way that we think we've got real expertise that we can provide and technology that we can introduce to treat those patients with heart failure. And so it's the reason why we're now starting to build a foundation for implantable heart failure management with our Cordella device. And this is patients who historically have not had real treatment options that give the patient visibility to their condition and give the patient and the physician visibility to lifestyle changes and pharmaceutical regimen adjustments that can help them battle this disease more effectively. So we're excited about Cordella. We're also excited about Vectorious which is a technology that was created by a business that's based in Israel that Edwards invested in long ago and we recently bought the portion of it that we had not already owned and we think the combination of Cordella and Vectorious is an important cornerstone for starting this effort that we're undertaking in heart failure. So these are the first 2 investments in in structural heart failure, again, because we think it's a significant population of patients who need better therapies.

Okay. And sort of zooming out, if you think about surgical as providing part of the foundation for what has enabled your structural transcatheter businesses to lift off over time and be more successful that surgical legacy valve and valve leaflet design and it seems like, and this was coming out of CRT this past weekend, there's a realization that many of the sort of disease states are heading towards heart failure that are up until now being treated separately and I'd put mitral and maybe tricuspid and maybe even TAVR into that category. So over the long term, I guess, is that something that -- it's multi valve strategies or other things, and this is a longer-term comment, but the comprehensive care for the patients who is without intervention or highly likely to end up in heart failure, putting together more comprehensive multi-device, multitherapy solutions for that patient? Is that kind of part of the long game?

It sure is. And you're right, we have so much to learn and we're really better understanding now the interplay between these different structural heart conditions and diseases that patients face. But there's no singular journey. Different patients progress at different rates and the cause and effect can vary as well. It's one of the reasons why we're so excited about getting into structural heart failure because there has been a dearth of therapeutic alternatives historically for these patients. Heart failure is the #1 most expensive and highest mortality condition that patients face. And so there's a real opportunity for a company like Edwards to introduce new technologies, but we also want to do it in a way that is strategic and thoughtful and really helps us focus in areas where we have a core competency to bring to bear and we feel like we're getting started in that journey now in a meaningful way with Cordella and Vectorious. You also mentioned in your previous question, aortic regurgitation. And you know that we've made this acquisition of aortic regurgitation technology that we're pretty excited about. And we're a ways away from having a commercialized product, but we feel good about the learnings that we've developed. We feel good about the technology challenges and our ability to address those and eventually to commercialize a solution for a catheter-based replacement of a disease aortic valve that's a very different disease than aortic stenosis. So that's on the horizon as well.

Okay. So I'd be remiss not to mention early TAVR and sort of asymptomatic or moderate AS, as other kind of growth drivers, opportunities, expansion opportunities within TAVR. Maybe talk a little bit about what you've seen so far or what we might see over the next couple of years what some of the catalysts like guidelines might be to help sort of realize those opportunities?

Sure. So the early TAVR trial that you're talking about was a breakthrough trial for Edwards Lifesciences, and we presented the results at the TCT conference in the fall of 2024. In 2025, we started to see the momentum resulting from those clinical trial results. And it came in the form of more physician interest and focus or refocus on aortic stenosis. The trial demonstrated that symptoms don't matter, that patients with severe aoritc stenosis need to get their valve replaced regardless of whether symptoms can be identified or isolated or associated with the disease of aortic stenosis, a diseased valve that level of severity needs to be replaced. And so we're excited about that learning. We're excited about the ability to treat more patients who have this disease. And as you know, now CMS is going through the process of evaluating the current national coverage determination, and we'll see the first draft of that early this summer. And we hope that, that leads to a more accommodating NCD that helps patients with symptoms and without symptoms navigate more easily the referral pathway to actually getting their valve replaced.

Got it. And I guess there was some split in the community for those folks who felt like they had, I guess, a great deal of control and connection with their patients who come in and are diagnosed with AS might say, well, why would we want to treat this patient early? We'll treat we know the exact right time the day and the hour when we can treat this patient and get the most out of this next valve. And then the other part of the community, I think, would recognize as well, there are other folks who come in who aren't quite symptomatic, but they're severe, and I never see them again. And we don't know if they actually just expire in the interim. And so there's like 2 mines, I think. But one of the things that has changed is maybe a pivot towards this next valve has to last your lifetime to this next valve is maybe the first of a couple of valves or maybe 3 valves that you may have in your lifetime for lifetime management. How is that sort of -- how are you seeing that reflected in adoption or in hesitancy around performing TAVR, this realization that, sure, it may last 10 years, it may last 12, it may last 9 if you're young? But lifetime management is the strategy that doctors seem to be talking more about.

Yes. And as are we. But you hit on an important point. This ...

That's 2 points. Pardon me. Two important points, I think.

Well, they're probably even more than that.

I make a note of that actually.

Tally them all up. No, I think the most important thing that came out of this early TAVR trial is debunking the myth that watchful waiting was an appropriate way to care for these patients. Aortic stenosis -- treating aortic stenosis is not poetry and Jazz, it's science. A diseased aortic valve that has severe regurgitation needs to be replaced, regardless of what impression you may have of how that patient is acting or the valve needs to be replaced. And early TAVR was designed to test that thesis, and it was definitive and clear that, that is the right protocol. I think that it does lead to this question about lifetime management, and it's the reason why we've been designing the family of therapies that we make in such a way to support patients who have lifetime needs, including surgical valves. So our current INSPIRIS surgical valve is designed to accommodate a future TAVR in SAVR, future transcatheter valve to replace the surgical valve if and when the surgical valve reaches end of life. Similar story for transcatheter valves where patients can first receive a larger transcatheter valve like a 29-millimeter and later, if necessary, a 26-millimeter or a 23-millimeter inside that original prosthetic replacement. And so this is a lot of the work that we're doing internally to make sure that patients, young or older in between, have therapeutic alternatives to treat their diseases.

Okay. And then maybe in the couple of minutes that we have left here, just pivoting into the middle of the P&L and margins. I have gotten the question and you've gotten it more than me, obviously, at various times, why aren't we getting more leverage? Why can't -- these are high-margin products. Why can't Edwards margins be higher? But you've been, of course, investing in a lot of things, not just R&D, but building out capacity and training and market development and so on. So maybe talk a little bit about at a double-digit growth rate, which is different margin conversation than a high teens growth rate in terms of leverage. But at that, what's the -- maybe what are some of the considerations that help you strike the balance between how much we're driving to the operating line and how much we're investing in sustainable growth?

Right. So priority #1 at Edwards is investing for sustainable, durable organic sales growth. That's the #1 objective. We can accomplish that objective while also achieving margin expansion. And so this year, we're expecting about 150 basis points of operating margin expansion. Over time, in the years ahead, we are expecting and planning 50 to 100 basis points of operating margin expansion, which gives us both fuel to drive the top line, but also an ability to get leverage in the P&L and grow EPS at a rate higher than sales growth.

Okay. So pretty straightforward. I mean part of those investments, I think many companies when they invest in manufacturing are investing in the cost of goods line essentially in terms of fixed fixed operating costs and then leverage. rolling out new products, you're in a state of suboptimal unit gross margins, I'm sure, for some period of time. And then the labor sensitivity intensity of these high margin but high labor, how does that -- does that at all change the -- where we see these investments or versus where another company that's adding production lines for an FDA-approved product might be adding them?

Yes. You're right. Our fixed and variable expense ratio looks a little bit different than a company with a lot of PP&E involved in the production process. But suffice it to say that the growth strategy requires a lot of different expertise inside of Edwards, all working together. So our production engineers work very closely with our new product development engineers in constructing therapies that are safe, effective and manufacturable at scale. And of course, it all gets supported by our force out in the field where we're continuing to add resources in the form of field clinical specialists who support physicians performing procedures and all the other folks who are out supporting our hospital sites around the world. So we feel like we've got the right framework in place. We feel like we've got an excellent team that is really working harmoniously together to help grow the business and do it in a way that is financially sustainable as well.

Okay. So outside this room, oil, Middle East are big topics. not to dive into it, we're over time by a few minutes, but last time energy costs were up, didn't seem like they took much out of your performance or your P&L. Maybe just a quick word on exposure to Middle East and exposure to energy.

Yes. So it's too soon to say whether energy is going to be impacted for the longer term for us or anyone else. But I can tell you that our #1 focus right now in the Middle East is making sure that our employees are safe and well protected and able to continue to help the technologies that we produce get to the point of care for patients who need them. That's where we're really focused right now in the Middle East.

Understandable. Okay. Well, thanks so much. With that, we'll call it. Really appreciate you coming.

Thank you all.