Thank you everybody who's come to the Young Blood Conference, and Scott Ullem, thank you so much for trekking across the country in this lovely weather to join us here today. I appreciate it.
It's our pleasure, and I do want to introduce my colleague, Gerrianne Sarte.
Yes
who is going to be taking over as Head of Investor Relations in April. We're delighted to have Gerrianne in this role. She's a longtime veteran in MedTech and healthcare, and she's really looking forward to getting to know all of you.
Well, I'm excited to spend some time with you. Try not to bother you. Anyway, Oh, this chair makes noise. Sorry about that in advance. One of the things that has come up as I talk to investors is the TAVR market, all right? We went through this period, middle of 2024, where it was slowing, and we understood why it was slowing. Now we're in a period where it's accelerating, and I'd love your view on why did it accelerate to 11% in the quarter revenue for you? Market's probably closer to 7%- 8%, according to uncertain. How do we think about the sustainability of Edwards growth and the market growth?
Yeah. I think there's On the surface, it might look like it's slowing and accelerating more than maybe the underlying factors really would suggest. In 2024, we had this convergence of competing therapies that all hit the cath lab at the same time. Part of this was due to Edwards introducing things like EVOQUE. Hospitals got a little bit further behind in capacity, development than hospitals typically are. You know, there's always going to be a little bit of a gap between capacity and labor and brick-and-mortar space and what the future needs look like, but it became especially pronounced in that period. That's behind us. Hospitals, I think, it's more back to status quo, continually tweaking and expanding to accommodate these new therapies.
In the fourth quarter and the third quarter of 2025, the business performed well, and we saw a pronounced refocus on TAVR. Granted, in the fourth quarter, we had a easier YoY comparison. We only had 6% growth in TAVR in Q4 of 2024, so it was easier to turn double-digit growth in Q4 of 2025. Put the math aside, we saw this pronounced focus and actual sequential growth in Q3 last year over Q2, which is highly unusual, and it reflects positive clinical trial results from the EARLY TAVR Trial, presented at TCT in late 2024. This was studying patients who have severe aortic stenosis but do not demonstrate symptoms, plus FDA approval of SAPIEN 3 Ultra RESILIA for use in asymptomatic patients.
The combination of those two influences, we think, really inspired that higher sequential growth than just renewed enthusiasm and focus on TAVR. We also have, coming up this year, a new NCD, guideline evolution in the U.S. We already saw guidelines evolve in Europe in 2025, and just general a lot more attention on what's coming with TAVR.
Not to get too specific, but is what has happened is doctors have sort of shaken out their schedule? Like, when we talk to doctors, spoke with them five years ago, it was like TAVR, TAVR all day long. Two years ago, it was like: "Well, I've tried doing much mitral, I try to do tricuspid." Is it more just a matter that they have their days figured out and how they're allocating their times, or is it they actually opened up more cath labs, and therefore there are more people doing more surgeries?
It's a really good question, and the answer is both, and it depends on the hospital. In some hospitals, there is a situation where you actually need more physical space. Oftentimes, though, it's more driven by standing apart teams and making sure that the schedules can work between procedures, some of which take longer than others, and operators. One of the things, just as an example, one of the things that will be considered when CMS determines the new NCD is the operating, operator requirement. Right now, getting the schedule of a cardiac surgeon to match up with the schedule of an interventional cardiologist, different departments, different wings of the hospital, it adds kind of unnatural friction.
Mm-hmm
... in running an efficient cath lab, and it's one of the things that we hope CMS will address in the new NCD.
Lots of questions. What has the feedback been as you've gone through the NCD process, and how do you think about that taking place?
Very limited feedback at this point. I mean, the NCD was reopened at the end of last year. Edwards and lots of other respondents submitted letters to CMS, expressing points of view about what the new NCD should look like. We'll see a first draft of the new NCD this summer. I think June, July timeframe is what we hear from CMS. There will be another comment period, and then we expect the final NCD to come, you know, sometime late this year or early next year, or whenever CMS actually publishes it. It's their process, not ours, obviously.
Is there anything we can learn about the last time the NCD was opened? I think that was in 2019.
It's tough to say. I mean, the most recent relevant NCD that we've experienced is with the new EVOQUE NCD, which is the beginning of last year. It's actually a pretty good reference point because there are no hospital requirements, no site limitations, no operator requirements, and that's for a first-generation device.
Right
... treating a disease that is really untreated. we'll see, but at this point, there's nothing we can really take away other than expressing a lot of perspective to CMS that we've developed over 10 years since we've been performing TAVR procedures in the U.S.
We did a call recently with a cardiac surgeon.
Mm-hmm.
who was like, "I think we should still be there." I understand their sentiment, but how much of the voice do they bring to the table in creating this decision?
Surgeons have an important voice, surgeons have been treating aortic stenosis for decades and treating it very successfully. As Edwards is the leader in surgical valves and in transcatheter valves, we've had a chance to see the role that these technologies and these physicians play in patients' lives. Yeah, I think surgeons will weigh in. They'll have a point of view, interventional cardiologists, obviously, and CMS will take all of those things into consideration when determining the new NCD.
Okay. When we built our TAVR market model recently, Edwards took share in the quarter. Why do you think that is, and do you think it's sustainable?
I think probably the most noteworthy share shift that we experienced in the fourth quarter was in Europe, where one of our competitors exited the region, and their position basically got reallocated across all the different competitors, including Edwards. That was a notable share shift in that region. Overall, globally, we've seen pretty level share positions for Edwards.
Okay. How sustainable are things such as pricing, patient flow, physician training?
Yeah. Well, those are all very different elements, but let me try to take them.
In any particular order.
In any particular. pricing, you know, pricing's been pretty level for quite a long time. It changes by region, but globally, we've seen pretty level average selling prices. We model in our long-range plan, ASP compression over time as hospitals reach higher volume levels that then earn rebates and incentives. We plan and model lower average selling prices, but we haven't seen that recently. It's been pretty level. In terms of physician behavior and performance, like I say, I think there's a lot of enthusiasm among physicians. There's renewed focus on TAVR.
TAVR is on the podium, just on the speakers list at major medical meetings. With all of the clinical trial data that has come out recently and the forthcoming NCD, we expect this to continue to be a focus of physicians. There's another piece, too. Did you want me to comment on another element?
All of it. It was, I don't remember my own question. It has to do with patient volume.
Patient volumes, certainly we've seen an uptick in patient volumes and, you know.
Graphics, or what do you think that is?
I think it's across the board. You know, one of the things that we've been trying to do is make sure that we've got a lifetime management approach to helping patients suffering from this disease. What I mean by that is, whether a patient comes in and presents with the disease as an 80-year-old or as someone a decade or two younger, we wanna make sure that Edwards is supporting those cases with relevant clinical trial data and technology.
Yeah.
You know, we now have our surgical valves meant to accommodate future valve-in-valve procedures and our transcatheter valves meant to accommodate future TAVR procedures. We have, across our size ranges, these devices are designed to support future TAVR for younger patients who end up with valves that reach end of life and need to be replaced.
what % of the procedures do you think are now valve-in-valve?
Small percentage of the procedures today, but we do believe it will increase over time.
Okay. Then we are getting additional data at TCT this year on moderate AS.
Yeah.
People haven't started to talk about it yet, but I expect them to shortly. How should we think about the clinical trial design for that and what to expect from it?
We're optimistic about seeing this data. We don't know what the data are gonna say. We're looking forward to seeing the data.
Right.
When we first started this trial, we did it because we developed a belief, largely informed by physicians, that patients with moderate aortic stenosis can benefit from TAVR as an alternative. With that, we launched this trial. Obviously, we had a view that it was important, that there was an opportunity here, we would not have started the trial. The trial actually enrolled about two years earlier than we expected. Oftentimes that's a leading indicator of whether or not there's some benefit of this therapy for patients. Since we enrolled it two years early, we don't have any more information. We don't know what the patient demographics or profiles look like. We don't have any leading indicators about what the data may suggest. We're looking forward to the trial reading out in December.
There's some speculation on our fourth quarter earnings call about, "Geez, is Edwards talking more or less favorably about pro...?" There's no new information. You know, we talked about at our investor conference in December, we don't know anything more, and we will not know anything more by the end of our first quarter call either.
Can we at least conclude that because it enrolled two years faster, that there is a viable population out there, and it's not hard to identify and find these patients?
That seems like a realistic observation.
Okay. There's some conversation, like moderate AS is not either identifiable or, you know, isn't worth treating this early. What you're saying, two years earlier would not support that dismissal.
This is one where we have to defer to the data.
Okay.
we just don't have any data yet.
Okay.
We're looking forward to seeing it at TCT later this year, and a lot of these questions will get addressed, I think, when it gets unveiled.
Okay, I'll stop there then. TMTT, I think, is a good place to go to next, and I, I can spend, I think, the next hour and a half on that. One of the things I, I try to think about is how much of TMTT these days is mitral versus tricuspid? Gerianne, maybe this is a project for you, how to think about the different products you have going through, and if you can't divide it up, what can you sort of say what the lead contributor is? Is PASCAL the biggest piece of the revenue at this stage, for example?
Yeah. Well, obviously, we know exactly what the split is between repair and replacement-
Feel free.
and geographies and all that kind of stuff, but we have not shared that publicly. What I can say is our first entrée into transcatheter mitral and tricuspid therapies was with mitral TEER.
Yep.
Repair, transcatheter edge-to-edge repair for patients with mitral regurgitation. As a result, that's the bigger business, but rapidly, our other therapies are catching up. TEER for tricuspid patients in Europe, we are still waiting for and we'll have data presented at TCT on TEER for tricuspid patients in the U.S. Right now we have just a DMR indication for PASCAL, degenerative mitral regurgitation, indication for PASCAL in the U.S., and we've enrolled our FMR trial. We expect that we'll have FMR results to produce and hopefully lead to approval in the future. We haven't published a timeline yet.
That's not also TCT, or you don't know yet?
We have not published a timetable for that. Back to your question, though.
Yeah
... the split between. We've got repair and replacement, but both are evolving and growing. We've got repair indication, expansion, and geographic expansion, and a replacement. We're still pretty early on in the introduction of EVOQUE and very early on in the introduction of SAPIEN M3, both in Europe and the US. SAPIEN M3, of course, is our mitral, transcatheter mitral valve replacement with the SAPIEN M3 valve inside. I know I didn't answer your question, Joanne, about what the split is, but that gives you a little bit of sense of the, of the framework that we're bringing to with TMTT.
Right, you did share that TEER mitral is the larger piece, and the others are catching up rapidly.
Yeah.
That helps at least frame it somewhat.
Right.
Reminded me of, all the bits and pieces and the data rolling out. Do you think that there's a stage where, replacement exceeds repair?
We talk about this regularly.
Oh, good.
Physicians talk about it as well. The short answer is, we don't know.
Mm.
There are debates and speculations, one of the important learnings that we have developed over the last decade or so that we've been working on developing this TMTT group is having a portfolio is very important. Patients with mitral regurgitation present with different facets and different characteristics of the disease. It can be DMR, FMR, it can be chordal problems, leaflet problems, left ventricular disease, each patient is different. Having different solutions to offer to physicians when determining how to treat their patients is really valuable. If we just came with a TEER device, it would be a different conversation than when we come with a portfolio of alternatives. We're excited that the vision we had a decade ago has now become a reality, and we have repair and replacement for both mitral and tricuspid.
Excellent. M3 was just approved earlier in the year. What has been the feedback?
Positive so far. I mean, I think there's a lot of optimism about having this therapeutic alternative. Remember, for a long time, 10 years ago, everyone was focused just on transcatheter mitral replacement. This is before TEER had really taken off or before we had tricuspid replacement. This has been a long time, a-coming and a long time awaiting.
Yeah.
We're enthusiastic now that we can bring it to market and get it into the hands of physicians who have as an option. I think time will tell what that growth ramp looks like, and we'll talk more about that in the quarters ahead.
Okay. Versus some of the competitor products for TEER, I'm flipping back and forth the way you guys flip back and forth on this topic. Going back to thinking about clipping devices, what are you seeing on the competitive landscape?
Well, I mean, obviously, we're not the largest competitor. There's an incumbent, and I think that, where we're really focused is not so much on the competitive landscape, but on how do we grow the market?
Mm-hmm.
How do we grow the number of patients who are coming into the system to be treated with these technologies? The under-treatment rate, or the treatment rate for mitral and tricuspid disease is lower than the treatment rate for aortic stenosis.
Yep.
Aortic stenosis is already treated at a much lower rate than other deadly diseases, like different forms of cancer, and mitral and tricuspid are even lower. For us, it's not about how do we go battle the competition, it's about how do we facilitate more patients getting to the point of treatment so that they can get their disease treated. Edwards will be a part of that.
What is the answer to that? This may actually tie all the way back to the TAVR and NCD, where if you have more centers and you have more people who are trained, there are more types of procedures they can do.
Yeah, I guess procedural rates and access to treatment is probably different across the different diseases.
Mm-hmm.
Suffice it to say, for mitral and tricuspid, which are both pretty early on in their journey, a lot of this is about awareness. Awareness of the diseases and awareness of the therapeutic alternatives.
Yep.
For example, tricuspid regurgitation has been dramatically underreported, like hundreds of cases in the U.S. per year, not tens of thousands.
Yeah.
For a long time, the tricuspid valve was referred to as the forgotten valve. Yet, here we are with many patients suffering from tricuspid regurgitation with rare intervention by surgery. Now all of a sudden we find out it's a much more common disease than people thought. It's a very debilitating disease. The mortality, but even more notably, the quality of life of this disease.
Right
... is awful for these patients. Having a minimally invasive replacement alternative or a minimally invasive repair alternative has just brought new life and a new pathway for these patients, and we're just trying to make sure that physicians and referring general cardiologists and patients themselves know about the disease and the fact that there are options now.
Yeah. Some of it is patient education as well as physician education, how do you get to those patients? I feel like I've asked you or asked this question 40 times. Like, is it a direct consumer campaign? Late at night, am I gonna hear, like, see an Edwards, you know, program of some type?
Sometimes. There are multiple different channels that we use to reach patients. Remember, for a lot of the patients, for example, aortic stenosis patients are older.
Yeah.
Sometimes you're not only talking to the patients, you're talking to the patient's children.
Mm-hmm
and you're talking to the patient's caregivers.
Mm-hmm
... adult children. We have different communications strategies. We have different avenues for getting information and material to caregivers and patients alike, so that they understand the diseases, the different ways the diseases manifest themselves, and how to get to a heart team to get consultation about the best form of treatment, whether that's surgical or transcatheter, whether it's repair or replacement. Our hope and objective and efforts are aimed at getting patients to the point where they can get diagnosed and, if appropriate, referred to a heart team for a decision about where to go from there.
Okay. surgical remains part of the core portfolio. I mean, critical care was jettisoned. You kept surgical. Growing mid-single digits, should I just sort of put mid-single digits and drag it across on my Excel spreadsheet? What is driving that, and what sustains it?
Yeah. That's mid-single digits is a good long-term assumption.
Mm-hmm
... or expectation for both 2026 and beyond. What's driving it is we're still innovating in surgical.
Right.
Transcatheter, mitral and tricuspid and aortic, and some of the new structural heart failure therapies that we're introducing get a lot of the limelight. Surgical is still a billion-dollar plus business for Edwards and a remarkable and important category for patients who need surgical treatment. I think what's really going to continue to propel surgical is innovation, not just in the device, but also in the tissue treatment. We're getting ready at the American Association for Thoracic Surgery conference in May to present the 10-year results from our COMMENCE trial, which is studying our RESILIA tissue in surgical patients, and we're really enthusiastic about seeing that as well. Keep in mind, RESILIA tissue is the same tissue we use in our aortic valves.
Right.
This will be an important lens into durability, which is probably the most important consideration for Edwards and physicians and patients.
Are we still talking about durability for TAVR? Did the seven-year data set put that to rest?
Well, we hope so. I mean, it was compelling data. I mean, we were pleased with it. I'd say we weren't surprised by it, but we were pleased with the data, and it's yet another element of a large body of clinical evidence supporting the safety and efficacy and durability of the SAPIEN family of valves. I say the SAPIEN family of valves because it's a very different platform than other-
Sure
... TAVR and TAVI, technologies, and we're really pleased with the results.
Good. Just to swing back to surgical procedures, we're hearing more and more about robotic cardiac surgery. How do you think about that evolving the landscape of cardiac surgery, and where does Edwards get to play in that?
It's unclear to us where robotic surgery ends up playing the biggest role.
Yep
in cardiac procedures. Whatever role it plays, we're enthusiastic and encouraging. We think it's beneficial to have more focus on it. We think, obviously, Intuitive Surgical is a great company, and their added focus on cardiac care can only add to the spotlight that we would love to put on cardiac care more generally. Under any scenario, we welcome the additional focus and the additional attention and tools that could be provided, and we think that benefits patients, and obviously, Edwards will be there as well as the provider of the therapy.
Okay. Do you see that taking off?
I think it's early to say.
Okay.
I think that's probably a question better for Intuitive, but like I say, we think that surgical robotics, we think that imaging technologies, whether it's professional imaging or wearables technology, anything that brings more limelight and visibility into these diseases and to the therapies that can be provided is a good thing for patients.
All right. in 24, you made, I think you announced three, but actually was able to complete two acquisitions. I don't think they get a lot of attention, so maybe remind us of what they are and why they were important.
Do you want to talk about JC Medical? Maybe that's a good place to start.
I think that's a great place to start.
Okay. We can talk about Endotronix as well. JC Medical is a technology that is used to treat patients with aortic regurgitation. Think of it, aortic regurgitation, as a leaky valve, in contrast to aortic stenosis, which is a clogged valve. It requires a different valvular solution, totally different platform, different technology. We closed that acquisition. We've been working on it now internally for a while, and we've learned enough to realize a couple things. One, aortic regurgitation is a serious disease that needs to be treated. Two, it's vastly undertreated right now, partly because the only alternatives are surgical, and there are a lot of patients who are not eligible for surgery or would prefer a transcatheter solution.
Three, we really like the technology that we're working on right now, and we believe that with time, it can be trialed and ultimately commercialized for the benefit of patients. That's, that's where we are in AR. We still think it's a big opportunity. We're excited about it. And we'll talk more about the timeline in the, in the quarters and years ahead. The, the other acquisition that we made is of a device, trade name is Cordella, and this is an implantable heart failure management technology that provides patients suffering from heart failure and their physicians with visibility into how their heart is performing-
Mm-hmm
and how the pharmaceutical regimen they're on is impacting their day-to-day heart failure and how they manage it. It's been a really impressive addition to the alternatives for patients who are suffering from heart failure, and we're excited about continuing to invest in this technology and to continue to grow the footprint that we have in this technology for patients.
Where can your footprint in heart failure go? I mean, it seems like it's a toe in the water to me.
Seems like it's what?
A toe in the water.
Oh, it is. At this point, it is a toe in the water. At this point, our real objective is we're learning more about the technology and the disease ourselves. At the same time, we're helping physicians and hospitals, and hospital sites, introduce a new technology to patients who need it and can benefit from it.
How do you think about capital allocation and future M&A now?
Our capital allocation priorities are very consistent with where they've been historically. Priority number one is to make sure that we've got the infrastructure and capacity to support the growth of our therapies across Edwards.
Yep.
Making sure our production facilities are keeping up with demand. Priority number two is investing in external growth. Making acquisitions, generally smaller in size, focused on structural heart. We'll make minority investments. We provide seed capital to early-stage companies, and we buy other companies or options to buy other companies based upon how they perform against milestones and benchmarks that we set out. That hasn't really changed, and it will continue to be an important part of Edwards' strategy, although not a required part of Edwards' strategy. The acquisitions that we make and the external investments that we make are generally smaller in size relative to our market cap.
The biggest allocation of capital is the final priority, which is buying back shares. We think it's created real value for the company. We think it represents a good opportunity to give back capital to shareholders and to set up the company for value creation in the years ahead. Last year, we bought back a little less than $900 million of stock. In both of the prior years, we had repurchased over $1 billion in stock. It exceeds the amount of dilution that we need to cover each year. We're going to continue to look for opportunistic times to buy back stock.
What is the formula for where you hit that lever? Pull the lever, hit the button.
Yeah. Well, we don't announce it in advance, obviously, but we'll talk about it once we've done it. We've got about $2 billion left of share repurchase authorization today.
Okay. When you put together the guidance for the December analyst meeting, and then you reiterated it in early January, and then again two weeks ago, is there anything that's changed now that we're in mid-February from, call it December? What has changed?
I'd say nothing has changed since our earnings call a couple weeks ago.
Okay.
On the earnings call, we said that we had increased confidence in our sales growth guidance, 8%-10% for the company, 6%-8% for TAVR. That was the one update since our investor conference. Overall, I mean, we like the setup for the year. We had a very strong 2025. We've got a number of different influences that we think will benefit the company, both in 2026 and in 2027 and beyond. We're feeling positive about the business, both from a TAVR perspective as well as in TMTT and surgical.
Was there ever a year, and I'm sure I can look this up, but where you raised guidance on the fourth quarter call early? You did say a couple of times on the call, we, you know, increased confidence.
Yeah. I'm tempted to say yes back in the twenty-teens, but I'm not certain of that.
Okay.
I will say, it's not a common precedent, obviously, it indicated that we do have increased confidence, a lot of it is because of the way 2025 ended and the focus we're seeing in 2026 on these new technologies and this new clinical trial data.
... Is there anything you're seeing in the broader landscape that sort of you think investors may be missing or you might be worried about? I mean, very frankly, what I'm thinking of is a couple of months ago, everyone thought MedTech was fine, and now we're all worried about MedTech, and we're worried about everything from impact of the ACA to snow days, to pricing, to I don't know. I'd love, because you're closer to all of that, your opinion.
Well, obviously, from a stock market perspective, med tech got off to a rocky start in 2026.
Noticed.
I know you all know that. From a company perspective, that doesn't reflect the outlook that we have for this business in 2026 and beyond. I know that doesn't do you a lot of good if you're getting measured quarterly for your investment prowess. I think that at Edwards, we feel optimistic and confident about the growth trajectory that we're on, about the number of patients who are still untreated today, and about the role Edwards can play in bringing scientific evidence and new technology for physicians to be able to use to treat their patients.
I always end by asking, when we're together this time next year, what will we be talking about? I know you're going off to do something much more better. Much more better? That's not even grammatically correct. I don't even know what the phrase is, but the person who will be sitting there, what will we be talking about?
Yeah, it's a good question. I think it'll be similar themes, actually. I think we'll be talking about what happened with the NCD, how does the NCD look. Right now, we don't know what the new NCD is gonna look like for TAVR. By next year at this point, I hope we will.
Right.
We'll be talking about how the guidelines in the U.S. evolved. Right now, the guidelines in the U.S. still support or still don't reflect the data and FDA approval of asymptomatic, so we'll see how those guidelines have evolved. I think we'll be talking a lot more about the penetration of PASCAL and EVOQUE and SAPIEN M3 into the patient population suffering from mitral and tricuspid diseases. There's a lot that's gonna happen in the next 12 months. I think it's an exciting... You know, a lot of times at Edwards, you've said, you know, long years and years and years from now, it's gonna be exciting. We're at a point now where we're pretty excited about the next, you know, six, 12, 24, 36 months because there are so many different catalysts and influences on our business.
Excellent. Thank you so much, Scott. Gerianne, welcome.
Thank you, all.