Next stop, we have Edwards Lifesciences. Welcome, Bernard.
Thank you.
Thanks for coming.
How are you doing?
Good.
Excellent. Good to be here. Hi, everyone.
Maybe I'll let you open. I know you wanted to make some opening remarks to get started. You just go ahead and do that.
Yeah. No, thanks. No, look, it is. You know, we feel good about, you know, where we are at, you know, as a company. When I step back and reflect, you know, the reason why, I think we have a great, you know, strategy. We have, you know, strategic clarity. This is all about, you know, structural heart. Everybody in the company is focusing on that. You know, we have a great culture. Y ou know, the employees, about 16,000 are, you know, fully engaged, inspired by our patient-focused culture. Execution is amazing across, you know, the company. You know, the sale of Critical Care a couple of years ago, you know, help us even further, you know, to be very agile, you know, fast execution, and you have seen that.
All of this is resulting in in my mind, you know, very differentiated performance, but also, you know, sustainable performance. We had a great year last year. You know, Q1, you know, was the same. You know, growing double digit. Also, you know, it is less about double digit, more about broad-based across surgical, TAVR, Mitral, and Tricuspid, also broad across, you know, regions. This is, you know, what, you know, give us, you know, confidence. It is sustainable. People are behind us. Strategic clarity and great execution. Feeling good about, you know, the years ahead of us.
Okay. Great. Coming off Q1 results, obviously a strong TAVR quarter, kind of beating 2 points and really strong across the board. I don't know if there's anything you'd like to kind of say kind of post Q1.
Yeah. No, very pleased about Q1, obviously. Better than expected. You know, mainly driven by procedural growth. You know, basically, you know, market growth. And all of that, I'm sure you heard me saying about it is this renewed focus on TAVR. In the last year or so, we have produced, you know, so much evidence on TAVR. You know, EARLY TAVR. You know, long-term durability data. You know, PARTNER 3 , seven years. You know, PARTNER 2 , you know, 10 years. All of this together, you know, gave a renewed focus on the community, on the clinical community about, you know, focusing on these patients.
Basically, you know, mainly, you know, market in Q1, but a little bit of share also, mainly in Europe from the exit of one competitor almost, you know, a year ago now. A little bit in the U.S. too. You, you know us well. What we care the most about is unlocking, you know, the opportunity that we have in TAVR, and we are very pleased with what we see.
Okay. Great. We'll dig into a lot of that in a bit, but maybe first, just announced a new CFO since last week, I guess.
Yeah.
Maybe, you know, why did the board go with that decision and, you know, how should we think about the new CFO announcement?
Yeah. I was looking for a very experienced CFO with comprehensive experience, and I'm very pleased that Doretta accepted the job. You know, we have been talking a lot, you know, together. I was, you know, two decades, you know, in the banking industry. You know, leading banks. Also a CFO of a large, you know, pharmaceutical company. She studied a lot, you know, at AOL. She knows, you know, the kind of strategy we are having, differentiated, unique in MedTech, where we go early. You know, we have multiple bets.
We take risk to create, you know, categories and to lead, you know, categories. Having, you know, on board a CFO is going to help us and help me, you know, take this kind of decision to create, you know, what we are, you know, creating, you know, differentiated performance in MedTech. Very pleased, you know, to have her. She's going to start with us on June 1st.
Okay. All right. Good. I'll save most of my margin questions for her.
Okay.
Maybe high level since you are here. You know, how do you think about margin strategy? Does it kind of stay the same, the 50 to 100 basis points a year? How to think about, like, this year is kind of above normal or at the higher end of that range. How should we think about kind of the longer-term margin outlook for Edwards?
No, we are, you know, committed, you know, first and foremost to have, you know, differentiated, you know, top-line performance. What we said is, you know, for the year, we increase the guidance, you know, nine to 11. Basically, the midpoint at 10. We said, you know, 2027 and beyond, you know, growing, you know, double digit, about 10% with EPS leverage and 50-100, you know, basis points improvement on margin, you know, 2027 and beyond. We are still committed to that. You know, this year is more about, you know, 150.
This is what you can expect, you know, from us. You know, great top-line performance, EPS leverage, improving margin. We are very fortunate, you know, to be focusing on a space where, you know, there is a lot of opportunities. You know, we are the leader. Yeah, pleased about it. When I step back again, I don't believe there are many, you know, MedTech asset with this kind of durable outcome in front of them.
Sure. Makes sense. On TAVR, you saw an acceleration over the last year or so, and you obviously had a product coming from a competitor. Just even in the U.S., like, what do you think's kind of driven that acceleration, and how do you think we should think about TAVR growth, you know, against some of the tougher comps in the second half of the year?
Yeah. That's a good question. You know, first and foremost, you know, what give us confidence is the durability of SAPIEN, the SAPIEN platform, now proven at seven years and 10 years, and we know it is very important, you know, for valve. You know, the EARLY TAVR is giving, you know, this confidence that yes, treating patient early without symptom makes sense also. You know, for the year, you know, we have increased the guidance. Think about, you know, the new range, and you can model at the midpoint.
You know, this is, you know, what, you know, the way we are thinking about, you know, guidance, you know, for the year. We are trying always, you know, to give you a realistic guidance, you know, based on what we know. Longer term, what we said was, you know, basically, expecting mid to high single-digit. This is a wider range to be able to accommodate, you know, any scenarios. All of that together, you know, for TAVR will give us the opportunity as a company, you know, to grow, you know, double-digit.
Okay. When you think about, your competitor had six-year low-risk data. What are you seeing in the field, when you're talking to doctors? Are you seeing physicians think differently about TAVR and the valve that they choose in low-risk patients?
Look, I'm not going to talk about, you know, competitive technologies. We are very pleased, obviously, with our valve performance at 30 days, at six months, at one year, and at 10 years. It is the benchmark, you know, by far. We are focusing on that. You know, we are focusing on patient care, and we are focusing on physician having access, you know, to the best technology, to the best TAVR technology out there.
You've been taking share, I guess, in the TAVR market already though, right? Kind of expect that to continue.
We are saying Q1, you know, we have taken a little bit of share in the U.S. We are not focusing too much on that. You know, you know us well. You know the big opportunities about the market. I know that many people are talking about share. You know me. I've been saying that all the time. Share is lagging indicator. I'm not looking back. I'm looking about, you know, the many patient that today, unfortunately, are undiagnosed, don't have access to care, and making sure that they can have access to care. If we do so, we are going to have a great, you know, the next 10 years is going to be amazing, you know, for TAVR, for SAPIEN TAVR.
On the TAVR NCD proposal expected June 15th, I believe. I mean, the comment supported indication expansion, but there was some debate around the heart team requirements. Like, any sense for how you expect the TAVR NCD to play out and how it could impact the marketplace?
The TAVR NCD is going to be very important. It has been in place, you know, for a long time. You know, since then, you know, the TAVR procedure has evolved a lot. It is now, you know, the standard of care, in the U.S. and in many location around the world. We believe it is time to refresh that. You know, the heart team role is very important in evaluating, you know, the patient. We are looking forward, you know, to a more flexible NCD where the heart team can decide what operator, you know, can be in the room. It is obviously up to CMS to decide. The first draft, you know, mid-June, will give us an indication about, you know, the new NCD. The new NCD will be in place, you know, by the end of the year.
An increasing number of centers. Like, how does that help? Does that help open up capacity even for TMTT, or is it just more about TAVR?
I believe it is going to be about a number of things. You know, right now, you know, there are a number of patients in the U.S. who don't have access to care the way we should have access to care. This is going to help us having a greater and easier access to care, and everybody will benefit. You know, the patients, the physicians, and the healthcare systems because, you know, TAVR is a very effective procedure.
Okay. Makes sense. On EARLY TAVR, the data presented in 2024, I curious how much of that's already helping drive momentum in 2025. Is this kind of a new indication expansion for asymptomatic that's gonna come through and help the TAVR market? Kinda what you're seeing on asymptomatic?
What we have seen in Europe first is, indication has been approved, but also, you know, the guidelines, has been updated. Indeed, you know, the dogma of waiting for symptom has been eliminated, you know, in Europe with the new guidelines. In the U.S., you know, we don't have yet, you know, the new guidelines. And, obviously it is not yet covered, you know, by the NCD. We have not seen any asymptomatic patient in the U.S. What we have seen, though, through, you know, CMS data, is an increased number of echo alerts and increased number of stress test. This is a clear indication that, you know, the heart teams across the nation are aware of the latest data and are, you know, paying a close attention to these patients.
Moderate data. I don't know if you've seen the data or not, if you'd say or not, but, you know, when the data comes, assuming it's successful, you know, how do you think it impacts the market?
The moderate, you know, patient population is a large patient population. We started, you know, the study, you know, four or five years ago because we had a belief that, you know, treating this patient will be beneficial, you know, for them. We know that AS is a progressive disease, you know, potentially that treating this patient is also a good idea. We don't know the data. I don't know the data. We are doing, you know, high-quality data, high-quality evidence, you know, sorry. You know, with FDA-approved studies, you know, all of that. I'm not going to see the data until the last, you know, few days. It is going to be presented in a high-quality fashion at TCT.
Right after that, you know, we are going to do an event with for investors to go deep into the data and understand, you know, the implication of the data. As of now, you know, I have no more, you know, to add that. Yes, we were having a belief that it is a, it is an important disease to study first and potentially to treat.
Yeah. Once the data's out, you have to kinda do what you did with asymptomatic change guidelines and kind of the same process?
You know, potentially, it will depend on how the new NCD is written, so we will have to wait for that. Let's wait, you know, the guidelines at NCD. We know that all of the people in charge are leading, you know, societies. We know that this is a study coming, so let's see, you know, what's coming out from the NCD.
Okay. Fair. TMTT, you're still talking about $2 billion in revenue by 2030, which is about $300 million a year of revenue growth. You know, the mid point this year, I think around $210 million. How are you thinking about the acceleration in the TMTT line to get to that $2 billion in 2030 and the drivers there?
Yes. We feel good about it. Let me first bring some context here about we started TMTT about eight, nine years ago with the vision of having a portfolio to be able to realize this large market potential, mitral and tricuspid. Today, eight years later, we have this unique portfolio that nobody has, which is helping physician select the right technology for their patients. This year we are on track to achieve three-quarter of a billion in revenue, growing 40% at the midpoint. Doing well, the right pace. We have a number of catalysts coming in TMTT. We have a next-gen PASCAL coming end of the year.
We have a new indication, PASCAL Tricuspid in the U.S. coming end of the year. you have, you know, new geography for PASCAL also that we are expanding, new centers. For EVOQUE, we have now a growing body of evidence with, you know, mortality benefit, you know, eliminating, you know, the crossover patient. We presented that at ACC. All of that together with M3, is going to be additional catalyst, to move from three-quarter of a billion, you know, this year to $2 billion in 2030. The, the true, vision though is not 2030. We believe that, you know, mitral and tricuspid are going to be, probably as big as aortic stenosis, you know, 10 years, you know, from now. That's the opportunity there. Having this kind of portfolio is going to be very important to grow TMTT to this kind of big numbers.
On SAPIEN M3, CE mark in April 2025, FDA approval December 2025. How do you see the rollout of that going, kind of feedback from physicians and any differences between U.S. and Europe launches?
It's going very well. It's still early, granted. Very well, you know, patient love, you know, the technology. Again, it is not impacting, you know, PASCAL or, you know, any kind of TR devices. It is truly about, you know, non-eligible, TR patients. It is expanding, you know, the patient population who can be treated. This is why, you know, patient like it. It's effective, it is safe, and it is expanding, you know, the patient they can impact. It is doing very well. Still early, but we get great feedback.
Okay. On PASCAL, you've been taking share there. Even your competitor was expecting share to stabilize, and now they're saying it's going to continue to be share loss for them, share gain for you. How much opportunity do you see on the PASCAL side to continue that growth?
Yeah, I will make, you know, the same comment on share. You know, lagging indicator, let's don't talk about that. Let's talk about, you know, the potential. Many patients, mitral and tricuspid patient, you know, need a treatment. We believe that PASCAL is a great technology, highly differentiated, and physician love it. They achieve a great outcome for their patients. Important, we have seen that the mitral TR procedure now is increasing double-digit, quarter-over-quarter, which is great to see. It is the same playbook. When you bring best technology, great evidence, you support physicians, you know, automatically you are growing the category. That's an important playbook, you know, for us to remember. What I love about this playbook, it is a sustainable playbook. It is not like, you know, a, you know, a few quarters. It is very sustainable long term.
How do you think about replacement, you know, versus repair, in the mitral and tricuspid market?
We see different patient population, so they complement each other, and it help us, you know, grow the pie and grow the potential.
Okay. Kind of catalysts in TMTT, some of the new products, like next-gen EVOQUE, plan introduce second half 2027. How meaningful is that? Kinda what are the big changes there?
Yeah, all of the next-gen are important. You will see, you know, the next-gen PASCAL, you know, this year, end of the year, the next-gen EVOQUE, you know. By, you know, the second half of next year, we have also in the plan, you know, the next-gen, you know, M3, that we didn't talk, you know, too much about it. All of them are going to be meaningful improvement. For obvious competitive reason, I don't want to get into the detail, you know, before we launch it. Yeah, no, very pleased. That's like, not only, you know, we are the only one with this kind of comprehensive portfolio, but also, you know, we are bringing, you know, the next-gen. This portfolio is evolving too, to better technology.
CLASP II tricuspid regurgitation data later this year as well, right?
At TCT, yes. Yes. We'll be presenting at TCT, and we expect an approval in the U.S. thereafter.
That probably expand, I mean, that expands the market quite a bit for PASCAL, right? I assume there's not been a lot of, like, off-label use there in those TR markets?
No, I don't think so because there is an approved device in the U.S. It is all incremental. It is all up, an upside to the kind of revenue you see, you know, from TMTT today.
Okay. That's helpful. Next-gen PASCAL, anything you'd call out on that product?
No, the same. You know, Now, you know, all of this, you know, this is already, you know, contemplated into the current guidance that we have, you know, for TAVR, for TMTT, and for the company.
Okay.
With regards to 2027, we will provide a guidance at Investor Conference in December.
Okay. Helpful. The pipeline, maybe Innovalve, I don't know if there anything you'd say on Innovalve or kind of the aortic regurgitation opportunity.
Innovalve, you know, mitral transcatheter mitral valve is very complex, you know, to do. You have seen, you know, the space. For 20 years, you know, companies, including ourself, have tried, you know, to bring a transcatheter mitral valve. Many have failed. Finally, you know, we had a great one with M3, and we are already thinking about the next gen. Not just, you know, the next gen M3, but the next gen, you know, mitral replacement. It is why, you know, we have Innovalve here. The thinking is can we further expand the patient population that physician can treat with a mitral replacement. It is all about incremental. It is not about, you know, impacting each other. That's on Innovalve.
On AR, you know, our technology, Sojourn, you know, that's the name of it, is doing well. You know, we are doing a pivotal study. We are enrolling, you know, the study, you know, well. We will talk more, you know, when we know more about, you know, when we are going to finish enrollment, when we are going to present the data. Our vision for AR is very simple, the same what we discussed, you know, in the past. We believe that there are many patient who need a treatment, a solutions. The only solution available today is surgical. There is one just approved, you know, transcatheter AR technology. Our vision is to bring, you know, the best technology, innovate with the best valve for these patients.
Okay. Then in left atrial appendage, where you've talked about a product there, can you update us on the, you know, the timing and process there and, you know, what's the unmet need in that space?
Yeah. We still believe it is a big unmet need. You know, there are, you know, transcatheter solutions. There is some surgical solutions. We are looking at this one as a nice opportunity in surgical, and it is why, you know, the team has developed, you know, a very competitive technology. We believe we are going to bring it, you know, by the end of the year. As soon as we will bring it, you will see, you know, more, you know, the feature of this technology.
Good. I did want to touch on international just a bit.
Yeah.
Improved a lot this past quarter. It grew 12%, if I remember correctly. You've always been taking share internationally from your competitor that left the market. Just underlying kind of the outlook in the international market.
Yes. You know, as a matter of fact, you know, international in Q1 grew faster than the U.S. Even faster. The U.S. did very well, and Europe did even, you know, better than the U.S. In Japan, we did very well also. Now to temper a little bit, you know, the Japanese result, you know, Q1 2025 was very low. You know, Q1, the comp was favorable. Nevertheless, we see Japan as an important market for us. You know, we know that AS is the disease of the aging, and there is one, you know, country where, you know, the aging is very prevalent is Japan.
We are spending a lot in term of awareness, training the team, hiring the best people to make sure that Japan is going to be very successful. Pleased about Q1, double digit. I don't believe you should expect, you know, Japan, you know, being double digit in the next, you know, few quarters. Nevertheless, good performance expecting from Japan.
Okay. On heart failure, like you've been making a big push into heart failure. Just how do you see that space kind of developing over the next few years?
You know, before I answer, you know, directly your question, Travis, you know, let me offer a little bit about, you know, how do I see it over our core businesses. TAVR, surgical, mitral, and Tricuspid. Over the next, you know, four to five years, you know, we are in leading position with best technology, world-class evidence, many catalysts like we discussed. I feel very good about having sustained performance. What I mean by that is growing the top line around, you know, 10% with EPS leverage.
We are also thinking about long term, you know, beyond that, you know, beyond, you know, four or five years and expanding into a field, you know, close to us, which is a natural progression, and heart failure is a good one. We have many of these patients, we see them already. Many of them have mitral disease, you know, tricuspid disease. It is why, you know, we are investing in many of the different modalities to treat, you know, heart failure patients. They are more, you know, for long term than short term. Yes, you know, we are bullish also here. The same way we did it in TAVR. The same way we did it in TMTT 10 years ago.
Okay. That's helpful. I don't know if there was anything else you wanted to touch on. Those are kind of list of questions, and I think you had some closing remarks you wanted to make too.
Yeah, no.
Save some room for that.
Thanks. Look, you know, you have seen, you know... You know, again, you know, back to my introduction. You know, strategic clarity, great execution. You know, we have an amazing culture in the company. Everybody's dedicated. Everybody wants to win, and you have seen that in 2025. You have seen that in Q1. We are increase our guidance for the year, and we have a great outlook, you know, for the years to come. Thank you so much for your interest in Edwards.
All right. Thank you.
Thank you.
Thanks for joining us.
Thank you.