Edwards Lifesciences Corporation (EW)
NYSE: EW · Real-Time Price · USD
83.46
-0.69 (-0.82%)
At close: Apr 27, 2026, 4:00 PM EDT
83.46
0.00 (0.00%)
After-hours: Apr 27, 2026, 6:30 PM EDT
← View all transcripts

2024 Wells Fargo Healthcare Conference

Sep 5, 2024

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Excuse me, I can't see. We're good? All right, welcome back. I'm Larry Biegelsen, the Med Tech Analyst at Wells Fargo, and it's my pleasure to host this session with the management team from Edwards Lifesciences. With us, we have Bernard Zovighian, the CEO, and Scott Ullem, the CFO. It's gonna be a fireside chat. If anybody has a question they wanna ask, just raise your hand, we'll come around. Bernard and Scott, thanks so much for being here.

Bernard Zovighian
CEO, Edwards Lifesciences

Thanks, Larry. Thanks for having us. This is our pleasure.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

So, Bernard, let's start with the strategy, and I wanted to give you a chance to address the recent stock reaction. Were you surprised by the magnitude of the drop? And what's your message for current and potential investors?

Bernard Zovighian
CEO, Edwards Lifesciences

No, thanks, Larry, for getting into this one, which is an important question, for sure, so yeah, I would say a couple of things about, you know, the Q2 stock reaction. I would say disappointed, obviously. You know, no one, you know, feels good about, you know, this kind of acute reaction. A little bit surprised. The only little silver lining is, you know, this, you know, gave us, you know, attractive entry point for a share repurchase. And you saw, you know, the news this week, we have done a $1 billion share repurchase. So that's the only silver lining out of all of this, but you know, the message to investors is, in my mind, it is important to look at the big picture.

Yes, for sure, you know, TAVR Q2 result, in a way, are below expectation, no question about it. We are aggressively working at solving it, and I can tell you, I'm very confident about the potential of TAVR, the trajectory of TAVR, and I'm sure we are going to talk more about it. Now, you know, also, you know, TMTT, you know, TMTT, is becoming a growth contributor to the company, and you have seen that, you know, this year. You know, and we see that, you know, TMTT will increase its contribution to the growth of the company. Now, you look at, you know, the entire, you know, company, Edwards, you know, in Q2, we grew 8%, and we said that we are on track, you know, to deliver on 8%-10%.

8%-10% was the guidance for the year in December. So yes, I know that in Q1 we increased it to the high end of 8%-10% , and we are back to 8%-10% . But nevertheless, you know, we are 8%-10% , which is, you know, a good performance, you know, for the year. So the message is, you know, we are, a global leader, successful company. We are into, you know, big market, growing market. We have a capability and, you know, we should feel, you know, very excited about what's ahead of us. So that's, a clear message.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Thank you. So Bernard, you recently announced the sale of Critical Care, just closed, and the acquisition of four private companies.

Bernard Zovighian
CEO, Edwards Lifesciences

Yes.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

What's your strategic vision for Edwards, and how is the company gonna look in three to five years?

Bernard Zovighian
CEO, Edwards Lifesciences

Yeah, no, thank you. That's an important question. And I, you know, I want to start with, you know, I have been with the company for almost, you know, ten years. It will be 10 years in January. So I was part of all of the strategic plan we have done in the last 10 years. The strategy has not changed. You know, the discussion of Critical Care, we had, you know, this conversation for many years. We just made a decision last year, and I am very pleased about the execution. We closed, you know, the transaction, you know, this week, slightly ahead of schedule. When you think about, you know, where we are going, and we are continuing what we started, you know, being this global leader in structural heart disease. But where we do it, in my mind, is very unique.

It is about, you know, going first. It's about, you know, creating category and owning the category, being a pioneer. I can give you, you know, a few examples that you know well, I'm sure. You know, on surgical, we have been the pioneer, you know, 60 years ago. We are still the global leader today, with global leadership in terms of share, premium pricing, because we bring value. In TAVR, the same. We have been a pioneer twenty years ago. Today, you know, we are the global leader, premium pricing, and we are still innovating with new technology, new evidence, and we are going to talk about it, you know, coming. TMTT, you know, the same. We were the first to say a portfolio is necessary. One modality, TEER, is not sufficient to unlock, you know, the market potential to treat all of the patients.

So you look at Evoque, category leadership, we are a pioneer. Mitral replacement with M3 and Innovalve, we are a pioneer. PASCAL and TEER, you know, we came second, but you see, you know, what we are doing right now. We are bringing evidence, new technology. You know, we are growing, you know, very fast. We are very pleased about that. So what you can expect in three to five years is Edwards, you know, being in structural heart disease, the leader, having multiple growing businesses. TAVR is today's, you know, the most important business for us, will remain very important. TAVR is not anymore, you know, the only business. That's probably the message. So feel good about, you know, what we are doing, executing the strategy, you know, basically.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Understood. The timing of the four recent deals or three, you know, at the earnings call, concerned investors, because it didn't seem like a vote of confidence in your TAVR and TMTT businesses. So how do you respond to that concern?

Bernard Zovighian
CEO, Edwards Lifesciences

Yeah, so don't misinterpret, you know, an announcement with, you know, a strategic decision made long time ago. So let me give you some example. You know, in the case of Endotronix, you know, we knew the company for a long time. We made, you know, we made the first investment in 2016 , an option agreement in 2018 . And in this kind of option deal, you know, what are you doing? You are doing a diligence, and you are saying, "Look, if you achieve this kind of milestones," in that case, for Endotronix, it was FDA approval and some kind of clinical outcome, you know, we will buy, you know, the company, and usually we have a very short window. For Endotronix, we had, you know, a few weeks. They got FDA approval, so in July, we made the decision to, you know, buy the company.

Innovalve was exactly the same. We made the decision in 2018 . Option deal, we wanted to see some clinical outcome. They achieved, you know, the clinical outcome. We made the decision in July also. AR, AR has been, you know, a very interesting space, you know, for us, where we see that these patients are untreated today. And so for a long time, we were watching, but we were also watching for clinical signals. At TCT last year, JenaValve, JenaValve, you know, presented clinical data, and we say, "You know what? We like it." And it took us, you know, months, you know, since, you know, TCT last year, you know, to be able to close the deal. So it is the way, you know, all of this strategy were long time in the making, strategic, planful , thoughtful.

They all happened, the announcement, in July, but that's just a coincidence.

Scott Ullem
CFO, Edwards Lifesciences

I'll just add, when we said at our investor conference in December, there are two or three things that are near-term decisions, these are the deals we were talking about. We did not expect that they were necessarily all gonna come in the same month, but that's how it played out.

Bernard Zovighian
CEO, Edwards Lifesciences

Yeah, no, that's a good idea. Yeah, thank you, Scott. Absolutely.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Building on that, you talked about, Bernard, building out an interventional heart failure franchise. I thought you said you were evaluating two to three heart failure deals. Maybe I misunderstood, but Endotronix is your first move into that area. Should we expect additional acquisitions in that franchise, call it in the next twelve months or so, and how should we think about deal size and dilution you're willing to accept?

Bernard Zovighian
CEO, Edwards Lifesciences

Sure. So probably not expecting, you know, more deals in the next, let's say, you know, 12 months. You know, obviously, you know, we have been a heavy, heavy investors in the last 10 years. You know, we have option deals, you know, today, active, you know, we are looking at. You know, we have equity investments. We are watching anything in structural heart disease where it can be, you know, a, an important market with a large unmet need, where we can be a category leader, be a pioneer, you know, being first. But I would not expect, you know, any deal in the next, you know, twelve months here. In terms of dilution, you know, you want to talk about that?

Scott Ullem
CFO, Edwards Lifesciences

Sure. Yeah, so on, let's say size and dilution, on size, usually what we look at is smaller-sized deals. We're not gonna do bet the ranch company-transforming deals because our strategy is focused on structural heart, and the opportunities that we have for external growth are generally earlier-stage companies that tend to be smaller in size. Now, they also tend to be unprofitable, and so most of what we buy is dilutive, but we try to offset the impact of that, at least in the short term, to medium term, by making other changes and reprioritizing where we're investing.

Bernard Zovighian
CEO, Edwards Lifesciences

But I think. Thank you, Scott. You know, this concept about, you know, being a pioneer, creating a category is so important. You have a different kind of trajectory. You have a different kind of impact, impact to patient, to physician, to the space, to innovators, to payers, to providers. Again, you remember, you know, the example I gave you, surgical, TAVR, Evoque, mitral replacement, AR is the same. So for Endotronix and for PASCAL, it is more about becoming second, aiming for leadership with, you know, a fast, you know, innovation, clinical research. But, you know, most of what we do is about, you know, being a pioneer, and if it is not about that, it is about, you know, aiming for leadership, you know, you know, fast.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

So on Endotronix, remind us of why interventional heart failure is synergistic with your structural heart business.

Bernard Zovighian
CEO, Edwards Lifesciences

Many of the patients, it is very, very easy answer, you know, Larry. Many of the patients we are today serving, mitral patients, tricuspid patients, have also heart failure. And so, you know, for us, you know, expanding within structural heart to heart failure, it makes sense. You know, we are also treating these patients today. We are talking to the physicians today, so it is a natural progression for us.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Okay. That's helpful. Maybe if we have time, we'll dig into Endotronix more later, but there's obviously other things to get to. Let's get the numbers out of the way first, before I wanted to dive into TAVR and Evoque, et cetera, but Scott, let's just, you know, there's obviously, I know you know, been a lot of focus on trying to figure out what 2025 might look like. We published the other day, when the Critical Care deal closed, we got to $2.55 for remaining, call it, you know, Edwards, for 2025. The pieces were, we looked at the midpoint of this, the prior 2024 guidance. It was about $2.75. We assumed about $0.40 dilution from Critical Care.

And so that's pro forma 2024 EPS of $2.35. We assumed you grow, you know, your 2025 EPS by 10%, and we used a lower share count based on the recent repurchase, and we got to $2.66, and then I think, deal dilution, we assumed about, you know, $0.14. And then interest income from the remaining $500 million in proceeds from Critical Care added about $0.03. I hate to go through all that math on the webcast, but I think that was the math that got us to about $2.55. Scott, of course, I'd love to get your reaction.

Scott Ullem
CFO, Edwards Lifesciences

Yeah. Thanks for the question, and we know that, everybody on Wall Street is trying to understand what the future looks like for Edwards Lifesciences. We're not going to give 2025 EPS guidance today. There are estimates on Wall Street that show earnings per share going up in 2025. That's not gonna happen. Our earnings per share will be lower in 2025 than they are in 2024. But one of the biggest influences on the course is what happens with the top line, and as we get closer to the end of the year, we'll have a better feel of what the top line looks like, and then how that flows down the P&L.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

The building blocks that you mentioned, those are the right considerations, but we're not commenting on the arithmetic around those considerations yet, so maybe we'll leave it at that for the short term, but what's especially important to note is 2025 is gonna be a transition year for us in terms of earnings and margins. In 2025, we expect that'll be a base off of which we resume EPS growth in 2026 and beyond. That makes sense. I mean, just a couple follow-up questions. I guess you said it would be lower, so when you say lower, you're talking about the old guidance, which was $2.75.

Bernard Zovighian
CEO, Edwards Lifesciences

Yeah.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

No, it sounds like we're not gonna get. How much lower today?

Bernard Zovighian
CEO, Edwards Lifesciences

It will be markedly lower than the $2.70-$2.80 range that we had for 2024. But beyond that, we're not gonna get more granular.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Okay.

Bernard Zovighian
CEO, Edwards Lifesciences

We're gonna do exactly what we said on the Q2 call, which is next month, when we announce Q3 earnings, we will also provide Q4 guidance, and in December, we'll announce our twenty twenty-five guidance, so exactly what we said we would do on the Q2 call.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

That makes sense. Just a couple follow-ups. The deal dilution, two follow-ups on that. One is we saw the announcement yesterday about headcount reduction, 3% of the remaining workforce or 540 people. That's what MassDevice reported. That should help, I would imagine. Then, you know, you spend about 19% on R&D. Where am I going with this? The question we've been getting is that you spend a lot on R&D, that investors don't feel like you should offset dilution from these deals. And Scott, you alluded to that earlier. My dilution math has called $0.14. Maybe that's too high. I mean, are you gonna try to at least offset that piece?

Bernard Zovighian
CEO, Edwards Lifesciences

So maybe let me start about, you know, what you talk about, you know, the right sizing of the organization. What you have seen yesterday is indeed, you know, management, you know, taking action. You know, you have, you know, the Critical Care business, you know, closed, you know, was it yesterday or the day before. And, you know, as an executive team, you know, we look at, you know, how to think about, you know, the Edwards world without Critical Care. So we rightsize about, you know, 20% of the organization went to BD, about, you know, 4,600 people. And so we rightsize the infrastructure, you know, without Critical Care. So yes, you know, this is going to take care of some of our spending optimization for 2025.

But, yeah, I think we will give you, you know, more detail, again, like Scott said, you know, Q3 earnings and investor conference in December. Do you want to add anything here?

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Okay. All right. Well, I'm sure people will have more questions later, but let's move on. The other big question really is TAVR. You know, but I guess I wanted to ask about the second half guidance. You know, the guidance, I think you lowered it from eight to 10 to five to seven for the Q4 for 2024 on the Q2 call, and I think you grew about 6% in the first half. So the guidance assumes basically this TAVR is similar in the second half to the first half. Why don't you think, you know, your TAVR growth will get worse in the second half? Or why, you know, how de-risked is that? I guess it's not, it doesn't give you any margin for error if things actually do get a little bit worse. So how de-risked is this updated TAVR guidance, in your view?

Bernard Zovighian
CEO, Edwards Lifesciences

So let me answer it in a couple of ways. You know, first, you know, we gave a range. So we were at six, we gave a range, you know, five to seven, so we could be a little bit lower or a little bit higher than, you know, what we did in the first half of the year. You know, second, you know, we had, you know, the July trend when we gave you the guidance, and July was aligned with, you know, the first half of the year, so we felt good about this guidance. And again, you know, we need to remember about, you know, the TAVR trajectory. You know, the TAVR, you know, it is largely underpenetrated today in the U.S. and globally. So there is a ton of potential.

In a few weeks now, you know, from now, at TCT, you know, we are going to release, you know, a very important, randomized study for, you know, a new patient population, the asymptomatic, you know, patient population. At ESC, you know, a few weeks ago, a week ago, we released, you know, another, you know, a randomized study on a female, you know, having, you know, TAVR, TAVI, in Europe, and so what you see is that, you know, it is largely underpenetrated. We are in a global leadership position. Twenty years later, we are still bringing evidence to unlock the market potential.

So if you ask me, are you, you know, "Do you believe, you know, you have more risk?" I say, "No, you know, we have, you know, probably more opportunity in the years to come, including, you know, next year and the year after." We feel confident. We are bullish on TAVR. Do we like, you know, what happened in Q2? Do we like about, you know, this year, you know, being in the five to seven? Absolutely not. But we are working aggressively on that. I'm sure I don't know if we are going to talk about it, because we see plenty of catalysts in TAVR to get back, you know, this procedure growth at the level we want and at the level patient needs, to be fair.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

I'm sorry. You said you don't know if we're gonna ask. I'm gonna ask about what? I'm sorry, I missed. I didn't-

Bernard Zovighian
CEO, Edwards Lifesciences

About the TAVR, you know, catalyst in the years to come.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Sure. Yeah, I was first, I was gonna ask about the near-term headwinds you called out on the Q2 call about crowding out of procedures. People are... So anything new in that regard, some of the issues you've called out on the Q2 call?

Bernard Zovighian
CEO, Edwards Lifesciences

No. You know, the same. You know, what I heard is, first, you know, you know, we look back as a team about in the last, you know, 5-10 y ears. Let's take the U.S. as a leading indicator. The procedure in cath labs have grown significantly. You look at all of them. You know, TAVR, Watchman, mitral, and, you know, obviously, you know, PCI and now, you know, tricuspid. The, you know, very healthy CAGR. So hospital have showed us that they can grow, and they grew by adding cath labs, by adding staffing, by improving processes. You know, what happened this year, the addition of, you know, two new therapy were approved, and we discussed that, you know, in the Q2 earning calls. And it is not, it is not just, you know, two new therapies, TriClip and Evoque.

It is also a new disease stage for hospitals to treat. So we need to learn the disease, we need to learn the therapy, they need, you know, to create, you know, a network, you know, all of that, to be able to grow again and to scale again. So we believe it is temporary. When we said temporary, we said it's not going to be a matter of days or weeks, but it is not also going to be a matter of years. It is going to be a matter of quarters. We are confident that all of these transcatheter procedures are profitable, are necessary for patients, and hospitals, again, have demonstrated that they can scale, they scale it, and they are going to do that. And we are helping them, you know. We are with them, working with them, to make sure, you know, they can do that. Do you want to add anything else, yeah?

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

So let's focus on the catalyst, but starting with EARLY TAVR.

Bernard Zovighian
CEO, Edwards Lifesciences

Yes.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

My question on EARLY TAVR is, you know, one of the pushbacks we hear is, "Well, it's just a pull forward of patients. These patients would have developed symptoms. They would be treated, you know, eventually anyway." You know, I guess my question is, first of all, what's your reaction to that? And, you know, historically, when we've seen a clinical trial come out from Edwards on TAVR, it's given a boost to the market. You know, is there a reason to expect that this would give a boost to the market, given what I said? People are saying, "Well, it's just, you're just pulling patients forward.

Bernard Zovighian
CEO, Edwards Lifesciences

No, you're right, Larry, and you know this field, you know very well. When we published and presented low risk, gave a boost to the high-risk patients. And also, you know, some of the low-risk patients were treated ahead of an approval. So we expect here that by bringing a high level of science, like we are doing, and I'm very proud about, you know, who we are as a company.

You know, this, you know, category leadership, you know, this commitment to science is super important. I'm glad, you know, we do it. You know, unfortunately, you know, we are one of the few. But, you know, bringing, you know, this kind of data on asymptomatic, you know, just imagine the kind of conversation that will happen within the medical community at TCT. Brand-new data, new patient population, plenty of learning. People are going to talk about it. Patients are going to talk about it. The referring cardiologists are going to talk about it. So yes, this has the potential to create a boost. How much of a boost? That's a good question.

Then, you know, the obvious, you know, the big inflection point come when, you know, if a study is positive, highly positive, you have an indication expansion, and you have an NCD, and automatically here, you have a big boost, but that's later.

Scott Ullem
CFO, Edwards Lifesciences

Just in terms of your question about the pull forward, if this was a therapy that had similarly high treatment rates as therapies for other deadly diseases, like forms of cancer, then you might, then that might be a consideration. When the treatment rates for severe aortic stenosis are in the low double digits, the concept of a pull forward is not a real risk. In fact, a lot of patients end up not surviving severe aortic stenosis and never demonstrating symptoms. And so that's not really a- consideration or a limitation.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

So Bernard, usually when the data comes out, it has a pretty fast impact on the market. It's before, like, guidelines or anything. The NCD, then you have to file for the indication, and then it goes into the NCD automatically. You think there's something different here, where the data itself won't.

Bernard Zovighian
CEO, Edwards Lifesciences

No, it could be the same. Yeah, look, you know, it is tough to predict, you know, what's going to happen.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Right.

Bernard Zovighian
CEO, Edwards Lifesciences

You know, one is, I have not seen the data. You know, as a company, you know, committed to world-class evidence, we have, you know, very strict, you know, restriction in terms of who get access to the data and when, and all of that. I have not seen the data. But, you know, provided, you know, positive data, you know, we can see a boost, you know, after the presentation, like we have seen in the past, and a bigger impact when we get indication expansion.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

And the other thing I just want to follow up on. I have heard you talk publicly about new indications, you know, having a kind of halo effect on the prior indication. So, like, when-

Bernard Zovighian
CEO, Edwards Lifesciences

Yes

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

... low-risk came, it helped-

Bernard Zovighian
CEO, Edwards Lifesciences

Yes.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

It makes me a little concerned to hear you say that, because it almost sounds like asymptomatic itself is not an attractive opportunity. Because there is some debate, if there's an asymptomatic patient, want to get a procedure, is how easy it is to diagnose these patients, right? So are you... I just want to clarify, you're not saying that, that you don't think the asymptomatic population itself is an attractive opportunity?

Bernard Zovighian
CEO, Edwards Lifesciences

Absolutely not. You know, I think the opposite. I just, I am careful about talking about the study. I have not seen the outcome before, you know, we see the study.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Okay.

Bernard Zovighian
CEO, Edwards Lifesciences

I know that, you know, this is going to be plenty of learning and plenty of debate about it. Today, people are talking, have a debate because we don't know, and we are going to bring the science-

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Okay

Bernard Zovighian
CEO, Edwards Lifesciences

... to talk about it in a thoughtful fashion.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Okay. I guess one other one. It was interesting to see on the TCT program, preemptive treatment of aortic stenosis as a session.

Bernard Zovighian
CEO, Edwards Lifesciences

Yes.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

I guess we'll all have to wait and see.

Bernard Zovighian
CEO, Edwards Lifesciences

Yes

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

... what that is, but it's definitely provocative.

Bernard Zovighian
CEO, Edwards Lifesciences

Yes, absolutely.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

All right. Anything you want to put add on early?

Bernard Zovighian
CEO, Edwards Lifesciences

No, you know, we, you know, I believe in TAVR, you know, we have so many opportunity ahead of us. I look at the next ten years of TAVR, very exciting. I'm very confident. You know, there are millions of patients, undiagnosed, untreated. Only severe symptomatic patients are today, you know, under the guidelines. We need to expand that. So which is why, you know, TAVR was great in the last ten years. I believe the next ten years for TAVR is going to be very exciting.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Right. I want to get to tricuspid and Evoque, but just two other TAVR questions that I feel like we need to answer. One is, Boston Scientific, if they come to the US next year, how you're thinking about that? And two, Abbott's low price strategy.

Bernard Zovighian
CEO, Edwards Lifesciences

Yes. So let me try to cover the two questions together. We always, in our, you know, strategic planning, have the assumption that with more competitor, we are going to lose some share, not in a big way, always. And I think, you know, in the past, we have been talking about that, no change today. But we look at where we are today, you know, we are by far the global leader with a premium pricing. There is no coincidence. It's better technology, better science, and we are helping our physician treating their patients in the best way possible. Long term, it is about growing the market. It is about being able to serve and treat more patients. This is, you know, for us, you know, the priority number one. Are we going to defend our leadership position? Absolutely.

Our priority is about growing the market. We are the leader, we grow the market. For sure, all of this competition, they are trying to grab, you know, few points of share from us. I get it. And we are going to defend ourselves because we believe we have the best technology. But so, I'm not concerned about that. You know, we knew it was the game. We are not surprised about pricing. We believe pricing, pricing reflect the value of what you bring to the healthcare system. And this is why we are very confident in our premium pricing technology.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Okay. I want to make sure we get to tricuspid. Scott, did you want to add anything to that?

Scott Ullem
CFO, Edwards Lifesciences

No.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

All right. Bernard, obviously, you ran TMTT before you became the CEO, so I'm sure this is near and dear to you.

Bernard Zovighian
CEO, Edwards Lifesciences

Yep.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

The launch of Evoque. Just love to hear an update on how that's progressing and talk about the kind of catalyst pathway there. There's a lot, right? We have data TCT, we have an NCD. What are the, you know, the catalysts that really drive adoption?

Bernard Zovighian
CEO, Edwards Lifesciences

So let me start, you know, first, Larry, with our tricuspid strategy. And by the way, you know, mitral is the same. From the beginning, seven, eight years ago, what we said is, this patient population is very complex and very diverse. One technology, one modality is not going to be sufficient. We needed a portfolio. It is why, you know, we are, you know, this very unique portfolio, and we are the only one, again, repair replacement for both, you know, mitral and tricuspid. So when we think tricuspid, we think PASCAL and Evoque, and both are going very well. On Evoque, indeed, it is the way to think about it. Here, we have in mind, you know, being the pioneer, creating the category and think about TAVR as a proxy. You know, being able to bring innovation.

You know, today, you know, we have gen one, you know, gen two and gen three are in the pipeline. You know, TRISCEND II is the first study, and we are going to see the full cohort in a few weeks, you know, from now at TCT. Then we are now, you know, partnering with physicians, centers to be trained, to create a network, to be ready to treat a new disease state, both, you know, TEER and Evoque. So this is the way we are thinking about it, being able, you know. So think about, you know, TAVR, 10 years of growth or more, you know, 15 years of growth, Evoque, you know, the same. What we have in mind is a multi-layer of growth, you know, for Evoque, you know, in the next, you know, years.

Starting with more centers. I'm sure you all remember at the beginning of the NCD for TAVR. I think it was only 200 centers. My guess is that the Evoque NCD will be about, you know, 200- 300 centers, and then it will grow over the years like TAVR, you know, grew, and now TAVR is at 850. More centers, better innovation, science, helping physicians grow their practice. The next decade of growth, you know, for Evoque and tricuspid, to be fair.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

And then also, we have the NTAP going into place in October, and the NCD would be March of next year.

Bernard Zovighian
CEO, Edwards Lifesciences

Yes.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

And then TRISCEND II, I guess, you know, you've been asked this many times, how important is a statistically significant mortality benefit to adoption?

Bernard Zovighian
CEO, Edwards Lifesciences

I believe that, you know, all of this is important, you know, mortality, reduction in hospitalization, quality of the life, safety, efficacy, all of that is important. I can tell you that right now, you know, we have so much demand about the Evoque technology, so much demand, you know, worldwide. And so right now, it's not about not having demand. So the NCD, the NTAP and NCD will accelerate the demand. The TRISCEND II result, potentially, also will accelerate the demand. Our problem right now is not the increasing the demand. It is more about creating a category, training physician, making sure the patient are well taken care of, so we can experience 10 years of growth.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

... We have heard that actually demand is outstripping supply, but it's the supply of your ability to the clinical support, the people, so is that a fair statement, and what are you doing to add people that can support the cases?

Bernard Zovighian
CEO, Edwards Lifesciences

It is fair. It is not just support, it is also training physicians. It is, you know, how many teams could you train? We are approved in U.S. and in Europe. So we are hiring staff to train physician, to support physician. There is an imaging component also. So we are adding people. So it is all of that together. You know, we are scaling the TMTT organization to be able to scale, you know, Evoque, the Evoque procedure in the U.S. and in Europe. Think also about, you know, geography expansion. You know, we are going to also, you know, our goal is to bring, you know, Evoque, you know, everywhere, globally. So the scaling just started.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Bernard, I agree with you, PASCAL, for tricuspid, it's important to have a tier option. What's the status of the pivotal trial? I mean, there are two products approved. My concern has always been that it'd be difficult to complete that trial because patients are being randomized to medical therapy.

Bernard Zovighian
CEO, Edwards Lifesciences

We feel good about, you know, what we said. We are on track to complete the study by the end of the year, and we-

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Enrollment by the end of the year.

Bernard Zovighian
CEO, Edwards Lifesciences

Yeah.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

And then you've got to follow the patients-

Bernard Zovighian
CEO, Edwards Lifesciences

Yeah.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

- for 12 months.

Bernard Zovighian
CEO, Edwards Lifesciences

Yeah.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

That trial, you feel like you...

Bernard Zovighian
CEO, Edwards Lifesciences

We feel good, we feel good about that.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Not seeing a lot of crossovers and things like that?

Bernard Zovighian
CEO, Edwards Lifesciences

No, we feel good about it.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Okay. I wanted to ask you about Endotronix quickly.

Bernard Zovighian
CEO, Edwards Lifesciences

Yes.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

What attracted you to the asset, given what we've seen with the incumbent CardioMEMS? You know, about $130 million in sales, relatively flat. Why was this an attractive asset? And, secondly, you don't call on heart failure doctors today, I don't believe. So do you need to build a referral sales force? Thank you.

Bernard Zovighian
CEO, Edwards Lifesciences

So let me start, you know, there. You know, we are so I talk about why us getting into the space, natural progression, many, if not, you know, most of our mitral and tricuspid patient we are serving today have heart failure. So natural progression, one. When we look at the technology, we, we look at this one and we say: Look, you know, this one is differentiated. Easier to use, differentiated. We believe that, with also providing science, you know, that there is an NCD right now, you know, in play also, you know, with, with CMS. We believe, you know, this, this space, you know, can become, you know, very can grow, become very important. We can become a leader there, and I want to maybe draw a parallel with PASCAL.

When we started with PASCAL in TR, you know, the mitral market was barely growing. You remember, it was, you know, five, six years ago, it was not single digit. It was a single digit, you know, growing market. And we built at the time with using our playbook, with innovation, with science, and you can have a market grow and you can, you know, have an impact on patients. And here it is the same philosophy. I think like, Cordella, you know, which is the name of a technology, you know, from Endotronix, is differentiated. The data that they have show that there is some also clinical differentiation, so we are excited about the opportunity. Is it going to go big next year? No, you know, we are going to do it in a very thoughtful fashion, and learning and growing and scaling.

You want to add anything to that?

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

The sales force didn't

Bernard Zovighian
CEO, Edwards Lifesciences

Yeah. So sales force, their trial was in about, you know, 70 centers in the U.S. So this is where we are going to start. Obviously, they were able to support, you know, these 70 centers already. So this is where we are going to start. So yes, we are going to scale, you know, Endotronix a bit, you know, next year, but not in a big way.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Got it. But, but you will need to add people?

Bernard Zovighian
CEO, Edwards Lifesciences

We will need to add people, and we have kept the Endotronix organization separate, and this is the way, you know, we organize it in terms of maximizing the integration. There has been a private company for a long time, very experienced leadership team. So, you know, we have done a good job running, you know, the trial, having good outcome. So, we believe in their management.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Got it. All right, Bernard, we're out of time. I want to give you the last word. Feel free to make any closing remarks. Don't worry, we can go over a little bit. Is there anything we didn't cover today that you wanted to highlight or anything you want to just kind of summarize for us?

Bernard Zovighian
CEO, Edwards Lifesciences

Yeah, no, thanks. I would say a few things. I will say everybody was disappointed about the Q2 TAVR results. And I think it is important to say that Q2 TAVR result. You know, the company grew 8%. We are on track to deliver 8%-10%, which was our guidance in December last year. When I look about what's ahead of us, I am super excited. We are present and a global leader in large growing space. And we are adding now, you know, TMTT is becoming a reality, which is a contributor to the growth of a company. AR, here we have an opportunity to create this category and be the leader. So you look at ahead and what's ahead of us, you know, yes, TAVR will remain a very important business for us, but Edwards is not TAVR anymore, only.

We see, you know, plenty of categories. So very excited about it, very confident about it. So that's it. Also, final point is for investors. Right now, we have a stock, you know, prices, which is a nice entry point for-

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

Perfect.

Bernard Zovighian
CEO, Edwards Lifesciences

Thank you.

Larry Biegelsen
Sell-Side Equity Research Analyst, Wells Fargo

All right. Thanks for being here.

Bernard Zovighian
CEO, Edwards Lifesciences

Thank you, Larry. Thank you, everyone.

Powered by