Edwards Lifesciences at BofA Conference: Strong Growth Amid Challenges

On Tuesday, 13 May 2025, Edwards Lifesciences (NYSE:EW) presented at the BofA Securities 2025 Healthcare Conference, showcasing its robust financial performance and strategic initiatives. The company reaffirmed its growth projections despite challenges such as tariff impacts and acquisition-related costs. CEO Bernard Zevigian highlighted significant growth catalysts, including new product approvals and strategic acquisitions.

Key Takeaways

• Edwards Lifesciences maintains its 2025 top-line growth guidance of 8-10% and EPS guidance of $2.4-$2.5.
• The company is optimistic about multi-year growth driven by early TAVR approval and new product launches.
• Strategic acquisitions, including Yanavar and Jesse Medical, aim to enhance technological capabilities and market presence.
• Despite tariff impacts, the company anticipates limited financial exposure due to its global supply chain.
• The TMTT business is projected to reach $2 billion by 2029/1930, with significant growth expected.

Financial Results

• Top-line Guidance: Edwards Lifesciences reaffirmed its 2025 growth guidance of 8-10%.
• EPS Guidance: Maintained at $2.4 to $2.5 for 2025, with a tariff impact of approximately $0.05 per share.
• TMTT Growth: Expected to generate over $0.5 billion in revenue this year, growing at 50-60%.
• Long-term Vision: The TMTT business is projected to reach $2 billion by 2029/1930.

Operational Updates

• TAVR Performance: Consistently exceeded guidance, with early approval expected to drive growth.
• Evoque NCD: Finalization in the US is a positive development, with training for centers ongoing.
• CE Mark Approval: Achieved for the first-ever transcatheter mitral replacement in Europe.
• Resilia Data: Presented eight-year data on leading tissue technology.

Future Outlook

• Double-Digit Growth: Targeting 10% top-line growth and faster EPS growth starting in 2026.
• Heart Failure Expansion: Building on acquisitions like Endotronics to enhance market presence.
• Mitral Opportunity: M3 expected to unlock significant opportunities in mitral replacement.

Q&A Highlights

• Tariffs: Impact estimated at $0.05 per share, with potential for more significant effects in 2026.
• NCD Reopening: Optimism about CMS reopening the TAVR NCD based on existing data.
• Asymptomatic Referrals: Efforts underway to educate physicians on new TAVR data.

In conclusion, Edwards Lifesciences remains confident in its strategic direction and growth potential. For further insights, readers are encouraged to refer to the full transcript.

Full transcript - BofA Securities 2025 Healthcare Conference:

Travis Steed, Medical Device Analyst: Travis Steed, the medical device analyst, and continuing our medical device conversations today. Next up, we have Edwards Lifesciences, Bernard Zevigian, if I said that right, CEO, and we got Scott Ullum, CFO. So great, thanks for coming. Good morning. Looking forward to the discussion.

Scott Ullum, CFO, Edwards Lifesciences: Pleasure to be here.

Travis Steed, Medical Device Analyst: Thank you. And so I I wanna open up with kind of a big picture question. And you’ve laid out commitments at the Analyst Day back last December, you know, just a lot’s kind of changed since then. And now you’ve been CEO for a couple of years, just like trying to think about your willingness to kind of talk about the commitments you laid out and how those have kind of unfolded and kind of the path forward here.

Bernard Zevigian, CEO, Edwards Lifesciences: No, no, thank you. It is a good, you know, first question. So good morning, everybody. You know, great to be here. You know, very pleased about, you know, the way we ended the year last year.

We had a strong Q4. The way we started the year, strong Q1, also what we said about the full year, 2025. I think this top line guidance, eight to 10, we have confidence given the way we started the year. The EPS $2.4 to $2.5 for the year that we gave in December at the investor conference. And what we told basically everybody at the end of Q1 is we are able to maintain it while also offsetting the upcoming potential dilution from the deal with Yanavarv together with the cost of tariffs.

So all of that in my mind is strong financial for the year, very confident about it. But you know what excites me beyond the number is all of the catalysts that we have in the business. The early TAVR approval for TAVR which is going to give an amazing multi year growth opportunity in TAVR. You know the NCD for EVOQUE. So you know in The US, so many patients will be able to benefit from this amazing technology.

The CE Mark approval of the first ever transcatheter mitral replacement in Europe. You have the eight year data presented on Resilia which is our leading tissue technology and then you have a number of emerging opportunities but we don’t talk often about it For instance, the AR opportunity with the acquisition that we have done of Jesse Medical last year and now we started a pivotal study doing very well. We are enrolling well. There are many patients. And then in heart failure, we have two technologies: IHFM, Endotronics acquisition that we did last year.

Integration is doing very well, building the team, building capabilities. Together with insurance, we have an internal insurance program and we are also enrolling in study. So you look at all of this, we have so many catalysts ahead of us. Financial are solid, strong, but what I think everybody should be very excited about is what’s going to happen next year, the year after, in the next five years. So two years as a CEO, I feel good about you know, the way we are running the company, how the team is executing together with the many growth opportunity that we are having in front of us.

Travis Steed, Medical Device Analyst: And just like the last couple of quarters, you know, execution has been really good. Like TAVR has come in well ahead where you’ve guided, you know, hitting the guidance. And even on the P and L side, like you’ve been faced with headwinds and you’ve done a really good job of managing the P and L, you know, and offsetting some of the headwinds. I’m just like trying to think about like, is this kind of like the new Edwards, like we’re hitting and beating and managing expenses and growing earnings and stuff like that? Has there kind of been some kind of like change internally about how to kind of manage the business?

Bernard Zevigian, CEO, Edwards Lifesciences: So let me start and I’m sure you know, Scott, you know, can add, you know, some insights here. I would say yes, you know, we are very committed. You know, we told you, you know, during investor conference, said, look, know, what you can expect, going forward, starting in 2026, what we are aiming for is us growing double digit, 10%, with some variability year over year. But this is what we are aiming for, top line growing 10% and EPS growing faster than the top line. So we are very committed to that.

We have planned to be able to execute that in 2025. We are able to deliver on our original guidance while offsetting the tariff impact, the one that we know and because it is a fluid situation but also a dilution from Yanavar when we close the deal. But Scott, well said, that’s a nice summary.

Travis Steed, Medical Device Analyst: How does the China trade news over the weekend impact that? I guess it was $05 a tariff impact, I don’t know, 25 or on an annualized basis?

Bernard Zevigian, CEO, Edwards Lifesciences: I would say, you know, obviously, for the medtech sector, it is a positive one for us. You know, the beginning, China tariff was not a big deal for us. As a company, we don’t have any plans in China nor in Mexico. Our business you know as a percentage of global revenue in China is very small. So you know when I think about all of the tariff news you know we were and we are still protected mostly protected as a company.

I also love the way our global supply chain footprint is. We have plant in every regions, Europe, Asia, US. In most of the cases, the plant in region and fulfilling the demand of the regions. So you know it’s like you know not necessarily at risk you know from a tariff standpoint. It is a good news you know for the medtech industry for sure.

Also we are going to see some positive but very tiny for us.

Scott Ullum, CFO, Edwards Lifesciences: China, as Bernard said, China is a smaller piece for us relatively speaking. Our biggest exposures are in product coming from Singapore and Costa Rica, as we’ve disclosed previously. And so we think the impact of those, absent any additional changes in announced tariffs of 10% is something like a nickel per share in EPS this year. Now that’s a piece of it, as you know, this tariff expense gets, rolled into inventory and then we recognize it on the P and L as that inventory turns. And so we’ll have more significant impact without any further changes in 2026.

Travis Steed, Medical Device Analyst: Okay, that’s helpful. Then I’m very glad, you

Bernard Zevigian, CEO, Edwards Lifesciences: know, just to close on this one that, you know, all of the investment that we made, you know, but not only in R and D in the past years, but in supply chain. We have a very supply. You know, we have a very solid supply chain, resilient supply chain. We have seen that during COVID with almost no disruption. And we see that again, you know, during, you know, all of this tariff, you know, volatility here.

You we feel good about the way we are organized and all of the investment we made, you know, over the year.

Travis Steed, Medical Device Analyst: Good. Then your ability to kind of offset the InnoVelve dilution and just kind of shows the flexibility of your P and L here. How are you thinking about, what you’re offsetting it with? How are you managing the P and L from taking on the dilution? Like what are things you’re needing to cut internally to do that?

Bernard Zevigian, CEO, Edwards Lifesciences: In a very simple manner, it is about all priorities. We look at what are the biggest priorities, where we need to invest to realize the growing opportunity in the years to come. And this is always a priority. So innovation, science, high touch model, funding of emerging opportunities to make sure that we can deliver on what we said aiming for growing 10% with EPS leverage. And so we look at that on a regular basis as a team but we have a very strong leadership team.

We know the goal. We know the priorities and we can. This is another example in my mind. You commented about the execution that we have done in the last year of quarters. It’s a good illustration about how amazing is the leadership team, you know, being able to manage, you know, a new issue and deliver on it.

Travis Steed, Medical Device Analyst: Anything from the the Medington dilution that you would add?

Scott Ullum, CFO, Edwards Lifesciences: From the what?

Travis Steed, Medical Device Analyst: Managing the dilution from UniValvin.

Scott Ullum, CFO, Edwards Lifesciences: Well, you said flexible income statement. Yes, but it takes a lot of work. Mhmm. And there’s careful prioritization that goes into what we’re going to fund and then being able to be nimble enough to decide where we’re going to reprioritize that funding when we get curveballs like the tariffs that have impacted everybody this year. I mean, I think it reflects to your earlier point, Travis, the fact that we are laser focused first on organic top line growth, but also protecting the P and L.

For us, earnings growth, margin protection, margin expansion is an important part of the picture.

Travis Steed, Medical Device Analyst: That’s helpful and very, very good point. I want to switch gears to TAVR a little bit. First, I guess, maybe we talked about in the earnings call a little bit, the ability to kind of reopen the NCD. How would that process happen? Would they wait for moderate data to reopen it?

Would they want to reopen it now? Could they just trying to think through like in the past experience when you’ve seen these NCDs reopen, any kind of thinking on how this would happen at this point?

Bernard Zevigian, CEO, Edwards Lifesciences: So in short, I think today we have enough information and CMS has enough information to reopen the NCD. But before I go into this one a little bit deeper, let me bring some context into this one. So think about TCT last year when the PI presented the early TAVR results standing ovation. So in medical conferences, I know all of you attend, many of them. How often do you see standing ovation?

Not often. And this is clearly showing, you know, the importance of this trial and the solidity of the data we presented. High level of science, FDA studies, so that’s you know the best of the best in terms of science. And then you know a good indicator also about the importance of this trial is how fast the FDA was able to process the submission and provide an approval. So, these two things are clearly an indication that there is a need, patient need, clinician need, there is a need to change something here.

And if you think about now more about your question about the NCD, TAVR NCD was last changed a few years ago. Many things changed. TAVR became today the standard of care. It’s a very established, safe, high efficient procedure across eight fifty centers. And with this early TAVR data, the solid data, we believe it is a time now to do that.

So obviously it is up to the CMS to do it. We know they are aware. They follow the news. The FDA and CMS are talking. So we are very hopeful that it is going to be reopened and established in the right manner.

Travis Steed, Medical Device Analyst: Would we need to wait for moderate data to reopen it or they probably could do it and moderate would just kind of be added in later?

Bernard Zevigian, CEO, Edwards Lifesciences: I don’t think so. I don’t think we are going to wait for moderate. The way you need to think about the target opportunity is that we got the FDA approval. I believe we believe that CMS will reopen the NCD and we are going to have a new NCD. But also, you need to think about policy changes, guidelines changes across the different regions, The US, Europe and Japan.

And all of that together in my mind in the next year, year and a half. The beauty of that is we are going to see the multi year growth opportunity in TAVR and all of these are based upon the best TAVR technology out there. The beauty of that also is right after all of that is done, we are going to see end of next year, end of twenty twenty six, you know, a moderate data and so again, another cycle of growth, you know, in TAVR with, you know, moderated data if data are positive. And

Travis Steed, Medical Device Analyst: entity probably has, like, if you’re operating requirements, I would assume more centers and all that. So that’s probably a losing the friction, if you will, and the TAVR growth is something that’s done.

Bernard Zevigian, CEO, Edwards Lifesciences: Obviously, you know, it’s tough to predict, you know, what the NCDs are going to look like. Can give you a couple of things to think about. One is when the NCD was established a long time ago in TAVR, at the time, you know, the standard of care was surgery. And so TAVR was this new technology that nobody knew about and it was important, to protect your patients. It’s why all of the things that were put in place.

And so if you look at the latest NCD, for instance, Evoque NCD last year or this year, I should say, You have no site requirement, you have no operating requirement and it is up to the company to ensure patient safety. We are going to follow-up patients with a post market study, all of these kind of things. For last week, way CMS thought about VNCD in 2025 for a very novel technology. So clearly, with all what we know about TAVR and SAPIEN, more than a million patients treated with SAPIEN with amazing results, very potential to for sure add centers, look at the site, look at the operator requirement, all of these. But CMS is in charge and will decide.

Travis Steed, Medical Device Analyst: And on the asymptomatic, maybe just talk about like now that the data’s out, been out for just now six, nine months and asymptomatic, are you seeing kind of referrals? Like, you expecting a little bit better TAVR growth in the second half as the label comes on online and into next year?

Bernard Zevigian, CEO, Edwards Lifesciences: So everybody is asking this question, Fred. So you know what you need to realize, you know, first is, you know, before the FDA approval, we were not allowed to talk about it. And so our team can now talk about it for ten days. We have a very comprehensive plan, ninety days plan about making sure that step one every physician on the heart team in The US understands the data. Step one.

Step two is understanding the implication of the data in their own practice. And step three is what are they going to do to adjust their practice, know, referring processes and all of that. So this is really that we are going to learn a lot. We are at the beginning of a process. We got approval like ten days ago or something like that.

But we are ready. The team is ready and we are starting to talk to all of these sites. If you think about two to three, two to four physicians by sites times you know eight fifty is close to 3,000 physicians to train and but the team is ready and very confident that you know we are going to impact patient care and is it going to change overnight? No, know it is as always you are going to have the early adopters, you know the one who are ready, the one who already know the data, who are going to adopt more quickly the changes and the one and some are going to be slower than others obviously. But the way we are going to support that, it is an important work to impact patient care in the most in the highest quality manner.

At the end of the day, what we do here, it is not just a business, you know, we are taking care of patients and that’s very important to us.

Travis Steed, Medical Device Analyst: It sounds like the FDA approval ten days ago was a pretty pivotal moment in the growth for asymptomatic, if you will.

Bernard Zevigian, CEO, Edwards Lifesciences: Yes, it is. I would say if you think about, you know, all of the key milestones, you know, one was having positive data, which we got. Having an FDA approval, which we got. Now you have, you know, NCD in process, policy changes, guideline changes in process. But yes, you know, two first were pivotal in being able to basically enable the changes in, you know, patient care.

Travis Steed, Medical Device Analyst: It’s the awareness within the referring doctors or cardiologists high enough? Are there anything you can do to kind of drive the referrals more to the interventionalists to do the procedures?

Bernard Zevigian, CEO, Edwards Lifesciences: I think it depends. Think about there is about 30,000 or so GCs in The US so some of them are aware, many are not but it will be also our job to making sure the heart team is well trained and educated on the study so they can educate their referring network. We will do that also but we are going to sort of equip it of a heart team to do that.

Scott Ullum, CFO, Edwards Lifesciences: A guideline too.

Bernard Zevigian, CEO, Edwards Lifesciences: Oh yeah and the guidelines is going to be very important because the GAC, you know, they are following guidelines. It’s why all of these are important. Yes. Thank you, Scott.

Travis Steed, Medical Device Analyst: And on moderate, first of all, you’ve talked about TCT twenty twenty six. Is there a potential for that to come earlier or is that not possible? And anything that kind of gives you confidence that that trial is going to be positive when there’s always the crossover stuff that kind of been talked about in your current trials that you just presented this past year. And then two, like on the moderate, any sense for how real that opportunity is versus like asymptomatic and the severe that you’re

Bernard Zevigian, CEO, Edwards Lifesciences: in today? These are good questions. Let let me start with you know, as a company, you know, we don’t, you know, start, you know, study lightly. You know, we do high quality science. We don’t do, you know, marketing studies.

We don’t do these kind of things. So we we have obviously when we start to study, we have belief based on our sixty five years of leadership in structural heart disease. So when we started the asymptomatic trial for instance, you know, eight years ago, we had a belief that waiting for symptoms was not a good idea. But studies were able to prove that. When we started the MODERATED trial, we had the same belief and we still have.

We need to prove it. And it’s important to lead the space as a leader like us, you know, with high quality science. So we have belief, we have hope here, we need to wait till the study. TCT 2026 is what you need to think about and not earlier than that. How big is the opportunity?

I would say there are many patients, many, many moderate patients, but it will depend on how solid the study result will be. If it is an amazing study result, it is going to be a huge opportunity and it is all about that. It’s all about science that you produce here. We are confident and let’s wait until 2026.

Travis Steed, Medical Device Analyst: Great. Switching gears to TMTT, this quarter I think revenue grew $42,000,000 year over year if I’m doing the math correct, if I remember correctly. How much of this TMT momentum there’s been kind of acceleration of business, much of that is coming from like Pascal versus Evoque at this point?

Bernard Zevigian, CEO, Edwards Lifesciences: So the beauty of TMTT in my mind is our vision is truly coming to life. Know, eight years ago, you remember I was talking about it at the time, you know, we said, look, there are so many patients, very diverse, very complex. One technology will not be sufficient. And we were the only one having this belief at the time and we committed long term with heavy investments, heavy investment in R and D, in clinical and today, you know, we have this unique portfolio that nobody has And so you see that it is coming from basically Pascal and Evoque and US and Europe. And everything is producing high growth, a great contribution.

And it is now just the beginning of N3. We see Mark. We are still on track to get an approval with N3 in The U. S. So think about the number of catalysts here happening in TMTT.

This year we are on track to deliver a little bit more than half a billion growing 50%. Pretty amazing. If you step back and you look at this one, half a billion business, growing 50%, sixty %. And what we told you in December is the vision is more than a vision, it is an expectation that TMTT will reach 2,000,000,000 in 02/1930. So it is not just this year or next year, it is truly a long vision here and to have a big impact on so many patients and to have a very successful business contributing to Edouard’s growth.

Travis Steed, Medical Device Analyst: It’s been a few weeks since the Evoque NCD has been finalized. Are you seeing anything now that kind of coverage is in place?

Bernard Zevigian, CEO, Edwards Lifesciences: I would say great news on the Evoque NCD. It is great for being able to create a category, build a category and lead the category for many years to come. Short term, the NZD is not going necessarily to help us. A little bit, know, right now, if you think about there are about eight fifty diverse centers, all of them want it. All of them want, you know, if we when we go into one city, whatever city, we open one Evoque center, all of the centers around it want Evoque.

So, our biggest opportunity, and it is an opportunity not a challenge, is to be able to grow, activate, train as many centers as possible. When the center right now when we talk to a center right now and they want to start, know, there is a wait list and we tell them, hey, you know, the earliest that we can give you a training is probably September right now. We are in early May, September, early October. So that’s being able to hire more people internally, train our people, train physicians so we can open more Evoque centers like we did in the last ten years, fifteen years in TAVR. So think about you know we are going to add evoke centers you know every year

Travis Steed, Medical Device Analyst: for the probably over three to five years to come. Maybe talk about let’s dig into that a little bit more in terms of how many Evoke Centers are there today, how many you plan on adding over time, what’s the process of getting one trained and how long does that take to get one center trained and kind of doing efficient procedures?

Bernard Zevigian, CEO, Edwards Lifesciences: So we try not to provide too many information about how many centers, what centers, for obvious reasons here. But I can give you a sense of how we are training them. So first, tricuspid disease in The US is kind of a new disease for the heart team. They didn’t have any technology available a year ago. So they didn’t see these patients.

These patients were kept at the GC level. So we do a lot of tricuspid disease training, one. And then, you know, imaging is very important for TR. So we do a lot of imaging training. So when a center is ready to start with Evoque, we bring them to one of the training centers and they come with already some potential patients.

So we have a live training on these potential patients with imaging, echo, CT We had them think about is it a good patient, is it not a good patient, where is the complexity of the anatomy, all of these together. And then they leave and we try it over a week after or two weeks after for them to start having multiple patients in a short period of time. So they increase their experience fast. Our team is there with them all the time and it is why we see this impeccable patient outcome and the kind of ramp we are having in The US and in Europe.

Travis Steed, Medical Device Analyst: I wanted to ask about M3 too. I think that’s maybe a product that doesn’t get enough attention. You just got the approval in Europe. When are we going to see that in The US and how big of a product do you think replacement in the mitral valve is going to be?

Bernard Zevigian, CEO, Edwards Lifesciences: A little bit like the same. I would say the same, but at the same time, we need to know more. In tricuspid repair and replacement, physicians are still, you know, learning about what patient for what technology. And it is very important there. Know, we are not pushing.

We have both. So we tell them, look, it’s not about, you know, which one you prefer. It is which one is best for your patients. When you have only one technology, you tell your physician with this technology you can do anything. Might be true or not.

For us, it’s like hey, select the best for your patient. Here it is going to be exactly the same and we are at the beginning of a learning. So this patient segmentation is going to be very important. M3, we are on track for an approval next year in The US, which is going to be very exciting. I believe it is going to be very important to unlock a fair version of a mitral opportunity.

What I love about this story, the Evoque story of the M3 story, truly about this is truly who we are as a company. For the last fifteen years, everybody talked about mitral replacement, transcatheter mitral replacement, including ourselves. It is very complex. Every one of us failed because it is complex. We remain committed, investing, having our team behind it, going to the next generation, applying the learning, for at the end, having the first transcriteria mitral replacement.

That’s really who we are as a company. We care about the space. We are long term committed. We have the best brain in heart disease and we bring this kind of innovation that nobody can, to be And at the end, you see the return here with Evoque, the first competitor behind us, probably four or five years behind, Transkeptical might get a replacement, who knows.

Travis Steed, Medical Device Analyst: And I wanted to ask kind of a question here on some of the acquisitions that you did last year. There was Endotronic, InnoValve, JZ Medical, InnoValve, like there were several investments that you made. Just trying to think about when are we going to start to see more on growth side of that? Any kind of updates on the portfolio that you kind of acquired last year?

Bernard Zevigian, CEO, Edwards Lifesciences: So I would say first, we have been an active investor in structural heart disease in the last ten plus years. We have made many early stage investments and usually we don’t talk about it. So last year, you know, made, you know, you know, Inovalve, so mitral replacement, because we believe mitral replacement is going to be very important and we want to make sure we are able to treat all mitral patients. Pascal is going to be very important and free is going to be important and we believe with Inovarb we will be able to treat more patients. So all of this technology they are not competing to each other.

They are complementing each other to unlock a lower mitral potential. AR and JCSI Medical today the only technology available are surgical technologies and we believe that with the Transcatheter technology we can do something here. We started already a pivotal study. We went very fast. The team did an amazing job at integration and we already are in a pivotal study in The U.

S. And with Endotronics, which is our first step into heart failure where there are so many patients and we are fully parallel integrating this technology. We said there are minimal impact this year. We are going to see some small impact next year. But think about heart failure as a natural progression for us.

Endotrannic was our first step and you are going to see more coming here. And the Yenaval one is still under review with our regulatory body and FTC and we are going to hear more hopefully this year. Thank you.

Travis Steed, Medical Device Analyst: I appreciate you coming to Vegas.

Bernard Zevigian, CEO, Edwards Lifesciences: Thank you so much, everyone. Thank you, Fritz.

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