Travis Steed, the medical device analyst, and continuing our medical device conversations today. Next up, we have Edwards Lifesciences, Bernard Zovighian. Yep. Did I say that right? Yep. CEO. And we got Scott Ullem, CFO. So great. Thanks for coming. Good morning. Looking forward to a good discussion. Pleasure to be here. Thank you. Yeah, yeah, please. I want to open up with a kind of a big picture question. You've laid out commitments at the Analysts Day back last December. A lot's kind of changed since then. Now that you've been CEO for a couple of years, it's 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 the path forward here. No, no, thank you. It's a good first question. Good morning, everybody. Great to be here. Very pleased about the way we ended the year last year. We had a strong Q4. The way we started the year, a strong Q1. Also, what we said about the full year, 2025, I think this top-line guidance, 8-10%, we have confidence given the way we started the year, the EPS, $2.40-$2.50 for the year that we gave in December last year at the investor conference. What we told basically everybody at the end of Q1 is we are able to maintain it while also offsetting upcoming potential dilution from the deal with JenaValve together with the cost of tariff. All of that in my mind is strong financial for the year, very confident about it. 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. The NCD for Evoque. In the U.S., 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 8-year data presented on Resilia, which is our leading tissue technology. Then you have a number of emerging opportunities. We do not talk often about it. For instance, the AR opportunity with the acquisition that we have done of JZ Medical last year. Now we started a pivotal study. Going very well, we are enrolling well, there are many patients. In heart failure, we have two technologies, IHFM, the Endotronix acquisition that we did last year. The integration is doing very well, building the team, building capabilities. Together within Shunt, we have an internal Shunt program. We are also enrolling in a study. You look at all of this, we have so many catalysts ahead of us. Financials are solid, strong. 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. Two years as a CEO, I feel good about the way we are running the company, how the team is executing together with the many growth opportunities that we are having in front of us. Just like the last couple of quarters, execution has been really good. TAVR has come in well ahead where you have got it hitting the guidance. Even on the P&L side, you have been faced with headwinds and you have done a really good job of managing the P&L and offsetting some of the headwinds. It is just like trying to think about, is this kind of like the new Edwards? We are hitting and beating and managing expenses and growing earnings and stuff like that. Has there kind of been some kind of change internally about how to kind of manage the business? Let me start and I'm sure Scott can add some insights here. I would say yes, we are very committed. We told you during investor conference, we said, look, 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. This is what we are aiming for, top line growing 10% and EPS growing faster than the top line. 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, because it is a fluid situation, but also the dilution from JenaValve when we close the deal. But Scott. That's a nice summary. How does the China trade news over the weekend impact that? I guess it was $0.05 a tariff impact, I don't know, in 2025 or on an annualized basis. I would say, obviously, for the medtech sector, it is a positive one. For us, from the beginning, China tariff was not a big deal for us. As a company, we do not have any plant in China nor in Mexico. Our business, as a percentage of our global revenue in China, is very small. When I think about all of the tariff news, 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 region, Europe, Asia, US, in most of the cases, the plant in region and fulfilling the demand of our regions. It is not necessarily at risk from a tariff standpoint. It is good news for the medtech industry, for sure. Also, we are going to see some positive, but very tiny for us. 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. 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&L as that inventory turns. We'll have more significant impact without any further changes in 2026. Okay. That's helpful. I'm very glad, just to close on this one, that all of the investment we made, not only in R&D in the past years, but in supply chain. We have a very solid supply chain, resilient supply chain. We have seen that during COVID with almost no disruption. We see that again during all of this tariff volatility here. We feel good about the way we are organized and all of the investment we made over the year. Your ability to kind of offset the UniValve dilution just kind of shows the flexibility of your P&L here. How are you thinking about what you're offsetting it with? How are you managing the P&L from taking on the dilution? What are things you need to cut internally to do that? 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. This is always a priority. Innovation, science, high-touch model, funding of the emerging opportunities to make sure that we can deliver on what we said, aiming for growing 10% with EPS leverage. We look at that on a regular basis as a team. We have a very strong leadership team. We know the goal. We know the priorities. This is another example in my mind. You commented about the execution that we have done in the last quarters. It is a good illustration about how amazing the leadership team is, being able to manage a new issue and deliver on it. Anything from the management dilution that you would add? From the what? Managing the dilution from UniValve. You said flexible income statement. Yes, but it takes a lot of work. There is careful prioritization that goes into what we are going to fund and then being able to be nimble enough to decide where we are 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&L. For us, earnings growth, margin protection, margin expansion is an important part of the picture. Yep. That's helpful. Very, very good point. I want to switch gears to TAVR a little bit. First, I guess 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 in the past experience when you've seen these NCDs reopen, any kind of thinking on how this would happen at this point? In short, I think today we have enough information and CMS has enough information to reopen the NCD. Before I go into this one a little bit deeper, let me bring some context into this one. Think about TCT last year when the PI presented the early TAVR results, standing ovation. In medical conference, I know all of you attend many of them. How often do you see standing ovation? Not often. This is clearly showing the importance of this trial and the solidity of the data we presented. High level of science, FDA studies, so that's the best of the best in terms of science. 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. These two things are clearly an indication that there is a need, patient need, clinician need. There is a need to change something here. If you think about now more about your question about the NCD, the TAVR NCD was last changed a few years ago. Many things changed. TAVR became today the standard of care. It is a very established, safe, high-efficient procedure across the 850 centers. With this early TAVR data, the solid data, we believe it is the time now to do that. Obviously, it is up to the CMS to do it. We know they are aware. They follow the news. FDA and CMS are talking. We are very hopeful that it is going to be reopened and established in the right manner. 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? I don't think so. I don't think they are going to wait for moderate. The way you need to think about the TAVR 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. Also, you need to think about policy changes, guideline changes across the different regions, U.S., Europe, and Japan. 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 a multi-year growth opportunity in TAVR. 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 2026, the moderate data. Again, another cycle of growth in TAVR with the moderate data if the data are positive. The NCD probably has a few operator requirements, I would assume, more centers and all that. That is probably loosening the friction, if you will, in the TAVR growth to some extent. Obviously, it's tough to predict what the NCDs are going to look like. I 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, the standard of care was surgery. TAVR was this new technology that nobody knew about, and it was important to protect your patient. It's why all of the things were put in place. If you look at the latest NCD, for instance, the Evoque NCD last year, or this year, I should say, you have no site requirement. You have no operator requirement. It is up to the company to ensure patient safety. We are going to follow up patient with a post-market study, all of these kind of things. That's really the way CMS thought about the NCD in 2025 for a very novel technology. Clearly, with all we know about TAVR and SAPIEN, more than a million patients treated with SAPIEN with amazing results, very easy potential to, for sure, add centers, look at the site, look at operator requirement, all of these. CMS is in charge and will decide. On the asymptomatic, maybe just talk about now that the data's been out for, I guess, now six, nine months, and asymptomatic. What are you seeing kind of with referrals? Are you expecting a little bit better TAVR growth in the second half as the label comes online and into next year? No, nobody's asking this question, Travis. All right. What you need to realize first is before the FDA approval, we were not allowed to talk about it. Our team can now talk about it for 10 days. We have a very comprehensive plan, 90-day plan, about making sure that step one, every physician, every physician on the health team in the US understand the data. Step one. Step two is understanding the implication of the data in their own practice. Step three is what are they going to do to adjust their practice, referring processes, and all of that. This is really like we are going to learn a lot. We are at the beginning of a process. We got approval like 10 days ago, something like that. 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 850, it's close to 3,000 physicians to train. The team is ready. I'm very confident that we are going to impact patient care. Is it going to change overnight? No. It is as always. You are going to have the early adopters, the ones who are ready, the ones who already know the data who are going to adopt more quickly the changes, and some are going to be slower than others, obviously. We are going to support that. It is 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. We are taking care of patients, and that's very important to us. It sounds like the FDA approval 10 days ago was a pretty pivotal moment in the growth for asymptomatic, if you will. Yes. I would say if you think about all of the key milestones, one was having positive data, which we got, having an FDA approval, which we got. Now you have NCD in process, policy changes, guideline changes in process. Yes, these two first were pivotal in being able to basically enable the changes in patient care. Is the awareness within the referring doctors, the cardiologists, high enough? Are there any things you can do to kind of drive the referrals more to the interventionalists to do the procedures? I think it depends. Think about it, it varies, about 30,000 or so GC in the US. Some of them are aware. Many are not. It will be also our job to make 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 the heart team to do that. Maybe a guideline too. Oh, yeah. The guidelines is going to be very important because the GC, they are following guidelines. It is why all of these are important. Yes. No, thank you, Scott. On moderate, first of all, you've talked about TCT 2026. Is there potential for that to come earlier, or is that not possible? Anything that kind of gives you confidence that that trial is going to be positive when there's always the crossover stuff that has been talked about in your current trials that you just presented this past year? Two, on the moderate, any sense for how real that opportunity is versus asymptomatic and the severe that you're in today? Yeah. No, these are good questions. Let me start with, you know us as a company. We do not start study lightly. We do high-quality science. We do not do marketing studies. We do not do these kind of things. Obviously, when we start to study, we have belief based on our 65 years of leadership in structural heart disease. When we started the asymptomatic trial, for instance, eight years ago, we had a belief that waiting for symptoms was not a good idea. The study was able to prove that. When we started the moderate trial, we had the same belief, and we still have. We need to prove it. It is important to lead the space as a leader like us with high-quality science. We have belief. We have hope here. We need to wait for 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 the science that you produce. We are confident, and let's wait to see TCT 2026. Okay. Great. Switching gears to TMTT. This quarter, I think revenue grew $42 million year over year if I'm doing the math correctly, if I remember correctly. How much of this TMT momentum—there's been kind of an acceleration of the business—how much of that's coming from Pascal versus Evoque at this point? The beauty of TMTT in my mind is our vision is truly coming to life. Eight years ago, you remember I was talking about it at the time. We said, "Look, there are so many patients, very diverse, very complex. One technology will not be sufficient." We were the only one having this belief at the time. We committed long-term with heavy investments, heavy investment in R&D, in clinical. Today, we have this unique portfolio that nobody has. You see that it is coming from basically Pascal and Evoque and US and Europe. Everything is producing high growth, a great contribution. It is now just the beginning of M3. With CMRC, we are still on track to get an approval with M3 in the US. Think about the number of catalysts here happening in TMTT. This year, we are on track to deliver a little bit more than $500,000,000, growing 50%. Pretty amazing. If you step back and you look at this $500,000,000 business, growing 50%-60%. What we told you in December is the vision. It is more than a vision. It is an expectation that TMTT will reach $2,000,000,000 in 2030. It is not just this year or next year. It is truly a long vision here to have a big impact on so many patients and to have a very successful business contributing to Edwards' growth. 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? I would say great news on the Evoque NCD. It is great for being able to create a category, build a category, and lead a category for many years to come. Short term, the NCD is not going necessarily to help us a little bit, but right now, if you think about, there are about 850 TAVR centers, all of them want it. All of them want it. When we go into one city, whatever city, we open one Evoque center. All of the centers around it want Evoque. 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 a center right now, when we talk to a center right now and they want to start, there is a waitlist. We tell them, "Hey, the earliest date we can give you a training is probably September right now." We are in early May, September, early October. That is 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 10 years, 15 years in TAVR. Think about we are going to add Evoque centers every year for 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 Evoque centers are there today, how many 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 efficiently procedures? We try not to provide too much information about how many centers, what centers for obvious reasons here, but I can give you a sense how we are training them. First, tricuspid disease in the U.S. is kind of a new disease for the heart team. They did not have any technology available a year ago. They did not see this patient. These patients were kept at the GC level. We do a lot of tricuspid disease training, one. Imaging is very important for TR. We do a lot of imaging training. When a center is ready to start with Evoque, we bring them to one of the training centers. They come with already some potential patients. We have a live training on these potential patients with imaging, echo, CT, and we have 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. They leave, and we try a week after or two weeks after for them to start having multiple patients in a short period of time. They increase their experience fast. Our team is there with them all the time. It is why we see this impeccable patient outcome and the kind of ramp we are having in the U.S. and in Europe. I wanted to ask about M3 too. I think that's maybe a product that doesn't get enough attention. You got the approval in Europe. When are we going to see that in the U.S., and how big of a product do you think placement and the mitral valve is going to be? 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 learning about what patient for what technology. It is very important there. We are not pushing. We have both. We tell them, "Look, it is not about which one you prefer. It is which one is best for your patient." When you have only one technology, you tell your physician, "With this technology, you can do anything." It might be true or not. For us, it is like, "Hey, select the best for your patient." Here, it is going to be exactly the same, and we are at the beginning of the learning. This patient segmentation is going to be very important. M3, we are on track for an approval next year in the U.S., which is going to be very exciting. I believe it is going to be very important to unlock further of a mitral opportunity. What I love about this story, the Evoque story, the M3 story, is truly about this is truly who we are as a company. For the last 15 years, everybody talked about mitral replacement, transcatheter mitral replacement, including ourselves. This 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 transcatheter mitral replacement. That is really who we are as a company. We care about the space. We are long-term committed. We have the best brain in structural heart disease, and we bring this kind of innovation that nobody can, to be fair. At the end, you see the return here with Evoque. The first competitor behind us is probably four or five years behind transcatheter mitral replacement. Who knows? I wanted to ask kind of an indie question here on some of the acquisitions that you did last year. There was Endotronix, UniValve, JZ Medical, UniValve. There were several investments that you made. Just trying to think about when are we going to start to see more on the growth side of that? Any kind of updates on the portfolio that you kind of acquired last year? I would say first, we have been active investors in structural heart disease in the last 10-plus years. We have made many early-stage investments, and usually, we do not talk about it. Last year, we made this UniValve mitral replacement because we believe mitral replacement is going to be very important. We want to make sure we are able to treat all mitral patients. Pascal is going to be very important. M3 is going to be important. We believe with UniValve, we will be able to treat more patients. All of these technologies, they are not competing to each other. They are complementing each other to unlock the mitral potential. The AR and JenaValve Technology, today, the only technology available are surgical technologies. 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. With Endotronix, which is our first step into heart failure, where there are so many patients, and we are fully right now integrating this technology, we said minimal impact this year. We are going to see some small impact in the next year. Think about heart failure as a natural progression for us. Endotronix was our first step, and you are going to see more coming here. The UniValve one is still under review with our regulatory body and FTC, and we are going to hear more, hopefully, this year. Thank you. I appreciate you coming to Vegas. Thank you so much, everyone. Thank you very much.