Edwards Lifesciences Corporation (EW) Earnings Call Transcript & Summary

Well, good morning, everyone. We really appreciate you all joining us today. Thank you for making the trip out here. For those of you who are in person. I'm Mark Wilterding, SVP of Global Finance and the Head of Investor Relations and along with the team had a role in putting today together and really excited for you to be here for the 2025 Edwards Life Sciences investor conference. We've got a great session planned for you today. In addition to the executive leadership team that we have in person who will be presenting, we've got a number of physician cameos and we'll also talk more about our product portfolio in detail and the progress we're making on a number of clinical trials. For those of you who are online, please note the presentation slides have been uploaded and so they are currently available on our Investor Relations website. Just 2 quick items. Please take a minute to get familiar with this slide here behind me. During the event, we will be making some forward-looking statements. It is possible that actual results can differ from our expectations. For more information, you can find detail on our website on the latest SEC filings as well. The other thing I'd highlight here are the non-GAAP financial measures regarding our performance our SEC filings, along with the reconciliations of any non-GAAP financial measures utilized to the most comparable GAAP measures are available also on our website at ir.edwards.com. With that, I want to introduce a really special video. One of the best parts of my job, I think, is highlighting just what makes this company so special. The physician partnerships we have, the people at the organization and the patients that we help and I think the team that helped put this video together did a really nice job of capturing that. [Presentation]

Good morning, everyone. We are -- I'm very excited about having all of you we value your interest in the company. We have very exciting topics to discuss today. One is about how we are going to talk about how special we are as a company. We have a great performance, we are on track to have in 2025 and our vision for 2026 and beyond. We have a very unique strategy in med tech with a clear vision around 3 key elements. We are now solely focusing on structural heart. And we are able to leverage the expertise and commitment of our 16,000 employees globally to impact patient care, solely focusing on structural heart disease. We are solving large and very complex needs with many patients having no other solutions today. And what we like to do, what we aim to do always is to go first. When we go first, we create the path and when we do so, patient benefits and innovation accelerates. And we have seen that across surgical, across TAVR, and across so many other fields when we enter first. So this strategy is working. Today, we are the global leader in structural heart. We are one of the fastest large-cap med tech company in the world. But that's today, in my mind, what's more important is where we are going. And I believe we are well positioned to deliver sustained and differentiated growth in the foreseeable future. I have only one slide looking back. And I can tell you, I'm very proud of the team and all the accomplishments we have achieved in 2025. We have delivered very significant goals. Many of them will have lasting impacts. So for instance, 2 practice-changing evidence, EARLY TAVR. EARLY TAVR is not just a study. EARLY TAVR is going to change the path for all aortic stenosis patients in the next decade. The 7-year PARTNER III, for instance, which is setting a new benchmark including TAVR durability. We launched not just 1, but 2 of the world first catheter-based replacement valve for mitral and tracker speed. SAPIEN M3 and EVOQUE. And we are continuing to be a top investors on our strategy. We are investing more than $1 billion a year in R&D while delivering profitable growth. So financially, I'm very pleased about where we are for 2025. We are on track to deliver on a high end of the original guidance of 8% to 10% that we gave you in December 2024. And we are on track to exceed our original EPS guidance from December 2024. So clearly, we are exiting the year strong, and this gives us confidence for 2026 and beyond. Our focus on structural heart give us the opportunity to deploy our strategy with speed and agility. And I love this strategy. I the fact that all what we have done in the past years to be solely focusing on structural heart disease. And we are going to apply this speed and agility across our core platforms, TAVR, Surgical and TMTT. Where we still see large opportunities with large unmet patient needs. So we are going to continue to invest and bring next-gen innovations, next-gen evidence. But we are also expanding our portfolio across structural heart with novel therapies for patients who have currently no other options. And the result of this very unique strategy is as Edwards leads in our mind, everybody benefits. So let me explain. Physicians have access to best innovation on a regular basis. Patient care and patient lives are transformed with our therapy. Our employees are part of something special, something meaningful, something mission-driven. And overall, we impact the practice of medicine, create value and saving at the same time for the health care systems and taxpayers. So how do we do this? We know there is plenty of patients in need, more than 20 million with very diverse needs. So we will continue to bring novel and differentiated innovation and world-class evidence to transform care for TAVR TMTT Surgical, TAVR and heart failure. But in addition, a concept which is very exciting. We are leveraging our 65 years of valve leadership to pioneer therapies for the many patient group, currently unaddressed. What I mean by unaddressed, we have no options today. And I want to give you some example, patients with asymptomatic AS, for instance, patients with mitral, patients with tricuspid or AR in need of a transcatheter replacement. Each one of these unaddressed patient groups. They represent a very large opportunity. It is an opportunity for sure for the patient. It is also an opportunity for us as a company. And we are the only company to committed to deliver first-of-its-kind innovation for all of these patients. We know it is not easy, but this is what we like to do. We're tackling big issues, solving them. And this is clearly the result of our 65 years of leadership and our long-term commitment. Later today, you are going to hear from our business leaders. In TAVR, we have best-in-class technologies. We have practice-changing evidence. And all of that together. It is enabling a new era of proactive disease management, and Dan is going to talk about that. In TMTT, we are now -- have a full portfolio, and this is enabling personalized care for this mitral and tricuspid patient. Daveen is going to talk about that. And in Surgical, our leading resilient innovation are transforming patient lives globally and YJ is going to talk about that later. In my mind, our core businesses are incredible. They are the heart of the company. They are set for long-term success, and we have so many catalysts and you are going to see some later today. At the same time, we are very committed to emerging opportunities in structural heart, reaching more patients, complementing our core and all of that is clearly a natural progression for the company. TAVR AR, we are developing new therapy for this patients who have limited option or almost no options today. IHFM, we are establishing here a new standard of care with the patient at the center of a care management. And we are not going to stop here, because there are many other structural heart patients in need today. So we are going to continue to invest and bring therapies for these heart failure patients. Now let me transition to financial outlook. I already talked about 2025 and how strong of a year it is. And 2026 is set to be another very successful year. What I like about the company today, it is also not depending about 1 business. It's led by 3 core businesses, diversified sources of growth across TAVR, mitral, tracker speed and surgical. So in 2026, we expect sales growth 8% to 10% or $6.4 billion to $6.6 billion. We are going to continue investing a high level of investment in innovation, while at the same time, improving our R&D and SG&A ratio, about 100 basis points of margin expansion, very much aligned with the commitment we made during last year at the investor conference with leverage EPS growth of 11% at the midpoint of $2.80 to $2.95, including the Innovalve plant acquisition in 2026 (sic) [ 2024 ]. So clearly, all of these metrics together are setting the stage for having another year of distinguished performance. And starting in 2026, our strategy will result in this many catalysts across our different businesses. I'm sure when you look at this slide, you are very excited like we are. Within the next 3 years, we are going to launch many next gen, next-gen SAPIEN, next gen EVOQUE, next gen PASCAL, next-gen M3 and more. But in addition, I'm very confident in our ability to pioneer new therapies to the many patient group I introduced earlier, the one that have no other options today, the one who are unaddressed or simply said, we are creating new markets. So let me elaborate, TAVR for asymptomatic patients, TAVR for moderate patients, TAVR for AR patients. So 3 big catalysts in TAVR, transcatheter tricuspid valves, surgical tricuspid valve, transcatheter mitral valve, transcatheter therapies for heart failure and we are going to briefly talk about that today later in the morning. So clearly, many, many near-term catalysts across the company, creating new options for patients. And all of this catalyst basically will result beyond 2026 in TAVR growing between mid- to high single digit, TMTT having an increased contribution to the company growth, reaching $2 billion by 2030 and having growth potential beyond 2030. Surgical mid-single-digit and structural heart failure, a number of technologies, together with TAVR AR adding an increased contribution to growth beyond 2026, obviously. This gives us confidence that we will be able to target 10% average annual total company growth beyond 2026. Obviously, some variability based on the timing of catalyst from years to years and leverage EPS like in 2026. I feel like we are very well positioned as a large-cap med tech company with plenty of opportunities, creating long-term sustainable differentiated profitable growth. In summary, we are very confident in our strategy, solely focusing on structural heart disease, the decision we made about 2 years ago. We are exiting 2025 with distinguished performance and hence leadership. Near term, so what I mean by near term is the next 3 to 4 years, our catalyst in TAVR, TMTT, Surgical will provide novel solution for the large and upgrowing needs of millions of patients, and we are confident we will be able to maintain our distinguished performance longer term between our -- so longer term, between our core innovation TAVR, Surgical and TMTT and our expanded opportunity, we expect sustainable growth and value creation. All of this is possible with the amazing employees across the company, 16,000 employees and the leadership of our executive team. We recently added a few leaders on the leadership team, adding in mind a couple of things, speed of innovation, but also focusing on therapy platforms. We want to accelerate and advance patient access globally. We truly work as a team, and we have one mission, patient care with speed and agility. So this is the agenda for today. You are going to have a very comprehensive overview of the company and all of the opportunities ahead of us. With that, I'm going to pass over the mic to Dan, who is leading our TAVR business beautifully. Dan.

Thanks, Bernard.

Back to you. [Presentation]

Well, it's certainly an exciting time for TAVR. And as we enter this new era of proactive disease management, we're really well positioned for growth. The shift is underpinned by unparalleled evidence, which now importantly includes proven long-term durability. We're expanding access to patients with important new indications, for example, like asymptomatic patients. And we have the opportunity to learn how TAVR can change the lives and improve the lives further upstream in its application in moderate disease. All of it made possible and only made possible by Edwards differentiated valve platforms. And we will continue to differentiate and continue to expand with our really exciting innovation pipeline. I'll take a moment also just to reflect on the last 12 months. And there's been a few important moments in our strategy. We've had a symptomatic indications approved in both the United States and in Europe. Those indications along with really important and meaningful evidence have caused a shift, a real shift and an important movement in TAVR guidelines. And also there's an evolution in policy that is happening. We had really, really important data presented at TCT with a PARTNER III 7-year long-term follow-up, and that data was presented and simultaneously published and our flagship platform SAPIEN 3 Ultra RESILIA continues to roll out globally and help extend our leadership position, all leading to a positive financial results for 2025. And we're on track to deliver 7% to 8% year-over-year growth. And there has been definitively a renewed focus in TAVR globally, and that is causing a renewed focus in growth in the market globally. I've been at this -- this is my 16th year working with the TAVR therapy, and I don't recall a 12-month period where TAVR has been so consistently in the news for all the right reasons. Every podium around the world, new evidence, subanalyses, both clinical and economic, we've seen updates and guidelines. We've seen expert consensus documents presented and published, all leading to very extraordinary amplification from podiums, publications around the world. And perhaps none more important data presented than at TCT this year in October, late-breaking clinical trial session sponsored by the New England Journal of Medicine, the long-term data from PARTNER III low-risk trial the 7-year follow-up. And this was highly anticipated for 2 reasons. The first is the 5- to 7-year period is often referred to as a window of vulnerability for bioprosthetic valves. If there is going to be a durability signal, if there's going to be a durability challenge with a bioprosthetic valve it's going to happen in this period. Second is this is a very, very first trial, whether it be for surgical valve or a transcatheter valve where patients were serially followed with echocardiography and more importantly, independently call lab adjudicated to contemporary definitions of VARC III for valve performance and durability measures, the very, very first time. And the results were so reassuring and positive for patients and physicians, not just because there was equivalents in long-term outcomes between TAVR and Surgery, but a new benchmark has been set for valve performance and durability performance over the longer term. The results for valve performance in this trial were excellent across every measure, and that sets a new benchmark in transcatheter valve performance. And those results are particularly reassuring because new evidence not only with our EARLY TAVR trial, but including our EARLY TAVR trial is suggesting that there is a significant patient benefit by treating earlier in the disease pathway. If -- when patients are treated before the onset of symptoms, there is a superior and significant clinical benefit. This is challenging everything that we know about clinical surveillance as a standard of care. One of the most important things that we're learning is this disease is unpredictable. You cannot predict the progression of this disease, highly unpredictable, and there's a high risk, as we all know, of not treating, but there's a high risk of waiting. So time is definitely not the friend of a severe aortic stenosis patient. And we're learning that it's not just the clinical benefit. We're learning that by waiting, there's an economic tax or to put more positively, there's an economic benefit for treating patients earlier in the disease progression pathway. It is now clearer that patients do better clinically when treated early. But also if we wait while that heart, the left ventricle is working harder and harder to deliver oxygenated blood to vital organs. If we wait, that just gives the opportunity for the patient to progress into acute valve syndrome to have cardiac damage. And with delayed treatment, you can save a life, but you're also going to have more complications, you're going to spend more days in hospital and you're going to have a higher opportunity to have repeat hospitalizations due to heart failure. And all of that adds up to real dollars and cents at the point of care, both at the health care system and at the hospital level. And this is really important information that is emerging that there is not only a clinical benefit, but an economic benefit for treating earlier in the pathway. It's our strategy. It's been our committed strategy. It's our leadership strategy of being committed to generating very, very high quality levels of evidence. And that evidence generation, consistent evidence generation has led not only to new indications, differentiated indications but has also led to clinical confidence, and that clinical confidence and indication expansion is leading to guideline evolution. And we talked about it before, but what's happening now is probably the greatest shift in valvular guidelines than has been seen in over 10 years. Specifically, we saw in 2025 the American Society of Echocardiography, who is typically very passive in reporting the news. They've made a clear shift, particularly for when critical findings like severe aortic stenosis are noted for very clear and urgent communication. This is really different. In their words, communication should be within minutes so that patients can receive timely access to care. Perhaps one of the biggest changes we've seen is, in Europe, where the European Society of Cardiology and the European Association of Cardiothoracic surgeons have made a number of significant advances with their guideline update, not just reducing their Class I recommendation for TAVR to the age of 70. But most importantly, if severe aortic stenosis is confirmed by echocardiography, refer for treatment evaluation, refer immediately independently of symptoms and independently of heart function. And this is a huge shift. This is a really, really important shift, and this has been confirmed also with the most recent publication at TCT on the global expert consensus, which validates all this. These are the people who do the procedure every day. They're referring cardiologists who are involved in referring these patients every day, surgeons who are involved in the procedure every single day doubling down on these guideline updates and perhaps suggesting an even greater sense of urgency for patients with severe aortic stenosis. What does it mean for the patient? Well, today, current standard of care of clinical surveillance and watchful waiting is a complicated one. Patients bounce around the system, multiple HCP visits in primary care and in specialty care, going in for heart team evaluations, physicians trying to assess, is now the right time? What is happening with the progression of the disease? What is your symptoms? How bad are your symptoms? Maybe we should do more imaging, CT, echocardiography, maybe let's have another look. All of this is time. Normally, more than 6 months, often more than a year, and that's just in the United States. Outside the United States, longer, all representing a significant barrier for the patient to get timely access to care. So the new guidelines, they aim to simplify this and reshape the pathway, making it very black and white, very easy if severe aortic stenosis is confirmed by echocardiography refer for treatment immediately. And if there is not a good reason not to treat, treat and treat with urgency, all supported now by guidelines. And importantly, by a quality metric defined by the American Heart Association of time to diagnosis to discharge home in less than 90 days, ambitious but possible. And this is changing the way that we look at the treatment of aortic stenosis. This is what proactive disease management looks like. Now the education of this, the democratization of this, it takes time, right? This is new. This is challenging dogma for over 50 years that we should be watchfully waiting and waiting for symptom determination. This is all being challenged, but it's new. And what certainly would help accelerate the adoption, particularly in the United States, is if the coverage policy was aligned to the indications and the guidelines. Today, that's not the case for the TAVR NCD. There is an urgent need to modernize the NCD. And the good news is this is a really high priority for CMS. And now that everyone is back at work and assuming it takes the normal pathway and time line of up to 12 months, assuming that it gets opened imminently, then we can look forward to an updated NCD in the United States before the end of 2026, which kind of lines up when the ACC and the AHA will be updating their valvular guidelines in the fourth quarter of 2026. So there are so many opportunities within severe aortic stenosis. We have new evidence, important evidence. We have new indications. We have evolving guidelines, all representing independent sources of growth. But at TCT next year, we're anticipating the data from the PROGRESS trial. And this data is going to help us learn more about how TAVR might benefit patients with moderate disease. And guess what, we're going to have the opportunity for more evidence generation, potential for more indication expansion and access to patients. And this creates another cycle and another layer of growth opportunity as we work through that. It's an exciting time. None of it possible, not the evidence, not the indications, certainly not the clinical confidence and the evolution of guidelines, none of it is possible without standing on the shoulders of outstanding innovation. And we definitively have set the global benchmark there with our SAPIEN platform. And we will continue to evolve and advance our innovation pipeline to meet the needs of patients and clinicians as we go through this new era of proactive disease management, which will amplify needs around lifetime management as we treat earlier and younger. Today, our flagship platform, SAPIEN 3 Ultra with RESILIA is definitely the global benchmark, not just for early outcomes but now proven long-term outcomes and proven durability and by design, it is the only platform that facilitates and provides a clear path for future interventions like valve-in-valve, like coronary reaccess if patients need as we treat earlier in the pathway and younger in age. It really sets a high bar and that bar gets higher and higher, but we're so excited about our next-generation platform, which is SAPIEN X4. Now the challenge for SAPIEN X4 is SAPIEN 3 UR. That bar is really, really high. But SAPIEN X4 offers the opportunity to completely change the game we have variable valve sizing. This is entering into the foray of personalized sizing for each patient, personalized valve solutions for each patient, not only, there are many new features associated with this valve platform that brings ease of use dimensions for physicians, for example, really simplified valve orientation or commissural alignment or on-balloon delivery or improve vascular access options with the platform. It's super exciting. The innovation process never stops. And in fact, it accelerates when you go into clinic, that's when you really start to learn and our engineers and talented team have already identified areas of opportunity to enhance this platform. We're going to take the opportunity to make a couple of those enhancements. We think that, that's going to be meaningful. We're working through the details of that, but it probably require some confirmatory clinical work in addition to the ALLIANCE trial, and we anticipate that we'll get that done in 2026. So if we look ahead with everything with the evidence, with indication expansion, with guideline evolution, we feel really good about 2026 and the guidance we're setting for 6% to 8%. But it's not just for 2026. The SAPIEN platform is the only platform proven to enable proactive disease management, unmatched clinical evidence, differentiated indications clinical confidence amongst the clinical community that is driving updates at a rapid pace within the guidelines and within coverage policy and the potential to even expand access further as we go further upstream with moderate and the learnings that we're going to have with the PROGRESS trial in 2026. All of this providing catalysts to support mid- to high single-digit growth, not just in 2026, but beyond that period and across the planned horizon for the mid- to long term. All the ingredients are there for sustained growth in TAVR. And I sure hope that you share my confidence in this therapy and 2026 and beyond as we go into this new era of proactive disease management. Thank you. And I'll hand over to my friend and colleague, Daveen Chopra. [Presentation]

Good morning, good morning. I think as we heard in the video, there are millions of patients out there with mitral and tricuspid disease. These are patients that are really underserved by today's medical therapies of surgery or other kinds of medicine. The vast majority of these patients, they're untreated. They're looking for options. And a lot of these patients, they can't live the life that they want. They can't do the things that are important to them. They can't play with their grandkids, take care of themselves. They're looking for options. They're looking for other solutions. And what we see is that many of these patients have a huge diversity in anatomies and clinical presentations. They require different types of devices different types of therapy option to most optimally treat these patients. And I think this is where the Edwards strategy, our portfolio strategy in TMTT of having a repair and replacement device for each of the mitral and tricuspid valve can really meet their needs and is really critical. It's critical not only to treat the maximum number of patients, but it's really unique to Edwards. It is unique to Edwards to have this portfolio of repair and replacement. And if you think about each product in the product portfolio, especially those new areas of mitral and tricuspid replacement. We're really meeting the needs of these unaddressed patients, right? We talked -- Bernard talked earlier about these groups of unaddressed patients that are looking for new therapies. And that's how we see mitral and tricuspid replacement and really helping reach their needs. And each of these therapies on their own really brings a lot of value to the health care system, bring values to patients, to physicians, to the health care systems and obviously to Edwards as well. And the way that this value is realized is that ultimately, if you look at the value, we are with having a portfolio of technology, we can now treat more patients. We have products that can treat more anatomies, we can ultimately treat a larger number of patients, number one. Number two, we now allows us to have personalize therapy selection, leading to better clinical outcomes. If you have the right product for the right patient, we believe you're going to get better clinical outcomes. It's better for patients, better for physicians, et cetera. And finally, third, when you get better clinical outcomes at a heart team, the referral physicians see it. The patient community sees it. And as a result, you start getting an increasing number of referrals because you're seeing better results, and this grows the overall kind of opportunity for more patients to be treated. And this kind of strategy, it aligns very much with what we're trying to do in Edwards TMTT to create enduring leadership. And what I mean about leadership, it's more about more than market share. It's about leading into how we work with ourselves, with the governments out there, the leading key opinion leaders, reimbursement agencies, having a leadership spot with the entire community, the entire ecosystem, and that's important to us. An example is we're already seeing this today, for instance, in tricuspid in Europe, right, where we've had our portfolio of repair and replacement now for several years, and we believe that we are very much in the leadership situation in working with the entire community for tricuspid in Europe right now. And so how do we realize this opportunity for each therapy in the portfolio? How do we ensure that we can really get this access to the maximum number of patients. It really depends on implementing the Edwards therapy development model. This is a model that we've been doing for 15 years in TAVR and how do we create a new therapy and bring it out to tens, hundreds of thousands of patients around the world. And we've been implementing this very well and this comprehensive therapy development activities or what we're trying to implement here in TMTT, whether you're talking about new innovation iterations, new clinical evidence, right? We just heard about that from Dan. Continuous procedural development, improving reimbursement. Those are all things that we are in the process of doing for each of the TMTT therapies to ensure ultimately, right, the goal of all this is to ensure ultimately that we can increase patient access so the most possible patients can be treated with these innovations. So first, let's dive a little bit into tricuspid and see what's going on there. I think as you all know, tricuspid treatment is relatively new. Just a few years ago, tricuspid treatment had very, very few options, right, and no transcatheter options. And what we're seeing is a transformation in the treatment of patients. We're seeing patients lives drastically improved in an amazing way with tricuspid transcatheter therapies. And for us, as you know, we have 2 different solutions. We have our PASCAL tricuspid solution on the right, which really we believe, offers a differentiated tier results. And on the left, we obviously have our EVOQUE product, which we think can consistently eliminate tricuspid regurgitation in patients. So let's first hear a little bit more about EVOQUE and the current clinical data. [Presentation]

As you just heard, there's a lot of new compelling evidence on EVOQUE that's really driving broader adoption. Two specific studies were kind of mentioned in that video. The first was a follow-up on our TRISCEND II pivotal randomized study. In a trial that was never designed to show a hard endpoint benefit, this trial showed an 18-month that hard endpoint benefit for EVOQUE, a statistically significant reduction in heart failure hospitalizations in the most severe TR patients. Fantastic to see that progression that over time, we're starting to see the benefits of TR elimination that improve over time. Second trial was actually a real-world registry, so large-scale real-world post-market registry, the STS TVT Registry in over 1,000 patients and not just centers that did it that use the product in the premarket trial. But now inexperience centers with no exposure to EVOQUE before, now in the post market, people are able to learn the therapy and get the same great efficacy that we saw in the trial. But we also saw an improvement in safety factors. We saw improved safety with lower pacemaker rates and lower bleeding rates than we saw in the premarket pivotal studies, showing that perhaps over time, these procedural improvements how we work together in the Edwards therapy development are starting to show out now in the clinical data. So very exciting for patients. Additionally, what we're also seeing is that EVOQUE continues to be a really predictable procedure now in the real world. It continues to be a procedure that's under 60 minutes with not a large standard deviation or variation in time. Additionally, while we see the elimination of TR in patients, very consistent elimination, referral physicians love it. Referral physicians love to see a patient grow the heart team, then come back with no TR. That's causing and we're seeing referral physicians to want to send more patients to the heart team to get EVOQUE. And finally, all of this is supported by the Edwards high-value field model, meaning that Edwards personnel are helping work on the pre-case planning of a case. We're helping work interprocedurally to ensure the best possible outcomes as well as post procedurally. So our relationship, our partnership is ensuring the best possible clinical outcomes. And all this is leading to growing physician confidence in EVOQUE and that momentum that we're kind of seeing quarter-on-quarter. Like we do with all technologies at Edwards, we continue to want to advance EVOQUE's innovation as well as make sure that we globalize this product to as many countries as possible. First, on the innovation side of things, in 2026, we'll offer and enable a second device access point, so using the same device in a different access point through vessels of the neck to enable about 5% to 10% of patients who have challenging growing access to have an on-label indication to treat with intrajugular access. Additionally, as we go to the end of 2027 in the second half, we expect to launch a new delivery system and a new valve for EVOQUE, our next-generation valve built off the RESILIA tissue platform. Both of these products, we believe, will continue to have amazing efficacy but also improve the safety to the next level as well as continuing to streamline and optimize the procedure to allow it to be even more scalable than it already is. Also, as you can imagine, like we do with Edwards, we launched these products initially in the largest markets of the world of Europe and the U.S. but we have to bring these products to around the world. There are over 100 countries in the world that have access to Edwards products. And EVOQUE, we're continuously bringing this technology to patients globally. So outside EVOQUE in the tricuspid space, we also have PASCAL tricuspid, which we believe really complements EVOQUE, having repair and replacement is the way to treat the most patients and with this TR indication of PASCAL, we really are seeing differentiated performance where this product is available in Europe. We're seeing that physicians really love for those tier eligible patients that PASCAL makes a lot of sense with its unique features. As many of you know, we've been running a large randomized study called the CLASP II TR study. This is for PASCAL's medical treatment. And we've already now -- we're just finishing up the 1-year follow-up of that trial. And so we expect now by the end in Q4 of 2026 to gain U.S. approval and we'll also present the data probably in Q4 or TCT or so next year. So we're very excited to help use this data set to bring this technology that's been available in Europe and doing well in Europe to the U.S. and the largest market of the U.S. Moving now from tricuspid to mitral, right? We're in an interesting inflection point in mitral, where now we're starting to launch mitral replacement, where we've had Tier for many years with great clinical results, but now replacement is extending a treatment to new patients who are undertreated, unaddressed patient groups from before. And for us, this product that we're launching is a SAPIEN M3 product, which really broadens that patient access. I'll talk about in just a minute. But I'll actually first start with PASCAL mitral. I mean for us, PASCAL mitral is a fantastic device that has distinct technology that really optimizes procedures and is the workhorse of our mitral portfolio. We believe that this device continues to have really differentiating design and continues to come up with new evidence to support it, right? It's a nitinol-based clips for really atraumatic, allowing for the best possible kind of post procedure, post-implant kind of results. Secondarily, it's got this cool feature of elongation so that when you're deploying it, especially in the sub-valvular apparatus, you're not getting caught in the cords. You can just make that procedure easier. And finally, its delivery system, very intuitive, very controllable, so you can get the device exactly where you want for predictable MR reduction. Beyond the device features, the data pool continues to grow. Not only do we continue to follow up our first randomized study, the CLASP IID study, which has now over 3 years of follow-up. We now have -- in the -- MICLASP study, a European post-approval real-world study has 1,000 patients enrolled and hundreds of patients with 2-year follow-up that we present at different conferences. And then we also have the STS Registry, with over 2,000 patients that have been presenting. So we continue to have build the body of evidence to show how fantastic PASCAL is in the mitral space. And on the right side, very excitingly, I'm pleased to announce that we have completed enrollment in CLASP IIF. This is our randomized study for PASCAL in functional MR patients. It's exciting that we've now finished enrollment that helps us move forward toward trying to get an indication for this product, both in the few markets that don't have an indication like the U.S. and Japan. And like all of our technologies, you can imagine that we're kind of relentlessly innovate PASCAL. We are already on our fourth iteration of PASCAL now, and we plan by the end of 2026 to launch our next generation. This is a product that we really think can streamline the procedures and advance outcomes with changes to both the implant as well as the delivery system. We think this will be fantastic for patients, and we'll have more details of this, as we get closer to launching in Q4 of 2026. Now in the mitral space, moving from a repair to replacement. As we talked about, SAPIEN M3 is the first truly transcatheter mitral replacement therapy. This is a space that people have been talking about, man, for 15, 20 years as long as TAVR, it's been hard to do. And now we finally have a solution that's in the European marketplace and coming to the U.S. And what's unique about this solution is that we created this very novel docking technology, a technology that creates this kind of landing zone in the subvalvular apparatus and then brings in an amazing valve, a valve we know very well, the SAPIEN valve that's been used in thousands of times in the mitral position in calcified mitral, et cetera, and we bring that into the dock to get a great kind of outcome. And you saw at TCT this year, we released our first -- the big pivotal study results, the ENCIRCLE study. So let's hear about those clinical results from some physicians. [Presentation]

How amazing to hear those results on that patient, how their lives changed. ENCIRCLE trial, a large pivotal study was obviously released to TCT and showed that we can significantly reduce MR. We can eliminate mitral regurgitation, while getting massive health status improvements in patients. At the same time, we were able to do so in a very safe manner, 0.6% mortality at 30 days. And this is in a group of patients that would buy surgery -- the surgical predictive risk score would have been over 6.5%, so 1/10 of the predicted mortality, fantastic. And now with these study results, right, we've already been working on trying to get U.S. approval, and we expect U.S. approval in early 2026. So fantastic to pick these results and build upon the early launch that we've had in Europe so far. We've been in Europe since about the summertime, and we're seeing great results, a lot of physician excitement for this technology, and we're taking those learnings to bring it to the U.S. now in 2026. And like every technology in the Edwards way, we are not stopping with the first generation. You saw on Bernard's slide earlier on, we're already planning to bring our amazing RESILIA tissue to this in 2027 and already working on our next generation for the future where we continue to take and look at the clinical data and how we can make improvements to the device. So all this overall leads to a sales outlook in 2026 of $740 million to $780 million. Some of this could be moderated by the pace in which we're creating these new care pathways, right? We're creating new care pathways for unaddressed patient groups in mitral and tricuspid replacement. But it also could be buoyed by all this new evidence. You saw several trials and great data coming out that's continuing to work through the referral community and can really help us on the positive side. And with that, as you saw, there are a lot of these therapy milestones that are coming, whether we're following up now the CLASP IIF study to help us eventually lead to U.S. and Japanese approval, the SAPIEN M3 U.S. launch, TRISCEND II, our pivotal trial. We expect now the 2-year outcomes to be released in Q2 of 2026 at a major conference like ACC or so, exciting. CLASP II TR and the PASCAL U.S. tricuspid launch as well as launching our next-generation device. There is a lot going on next year that we are excited for in patient care. But finally, in conclusion, right, I think you've seen that our goal with TMTT is to create this portfolio of technology of repair and replacement for each of the mitral and tricuspid to really allow for personalized care, to really help patients the most. And if you look, for instance, in the U.S., the largest market, we launched start off with PASCAL MR in the lower left. And then we brought EVOQUE. And so if you look at our current revenue base, those are the 2 technologies driving most of our revenue and accordingly, in 2026. But in 2026, we launched the next 2 waves in the U.S. SAPIEN M3 launches in early 2026. PASCAL Tricuspid launches in late 2026. So we go from our first 2 waves to our next 2 waves of growth, fantastic for patient care. And we believe that all this together really provides a clear path to $2 billion of sales in 2030. And each year, if you look at our growth -- our incremental dollar revenue growth, it's an increasing contribution to Edwards growth. For those of you at TCT, there was an interesting study called the PREVUE study, which talked a little bit about the prevalence of different diseases. And if you looked at mitral and tricuspid disease, look at the number of people who have this disease, man, it's greater than aortic stenosis. So while we feel like we have a great path to $2 billion in 2030, we actually feel like there's a great path beyond 2030, as you can imagine. Our technology to continue to treat more patients throughout the world in a fantastic way, and we're just looking forward to the future. Thank you so much. I'm very excited to call YJ to talk about the innovations in the surgical business now. Thanks. [Presentation]

Good morning. I'm YJ Oh. I'm excited to give you an update and an outlook for 2026 on our surgical business. Now we are continuing to see patients' lives around the world being transformed with our leading surgical innovations. More patients around the world are getting structural heart procedures and our differentiated RESILIA innovations are meeting patient needs around the world. And we're building on our leadership with new clinical evidence and broadening the portfolio. Now let me tell you about some of our patients that are benefiting from our surgical technologies. Let me tell you the story of Connie. She was diagnosed with rheumatic heart disease at age 18. And in discussions with her physicians and mature decision-making, Connie chose to have an Edwards surgical valve because she did not want to have a lifetime of blood thinners. In addition, she also wanted to have children. So she underwent her first open heart surgery in 2016 and currently has 3 Edwards surgical valves implanted in the aortic, mitral and tricuspid position. So today, Connie is a mother of 2, leading an incredibly active life, and that's in part into her surgical valves from Edwards. So surgery is growing across all types of patients. We are seeing more complex patients being treated surgically with multivalvular procedures. We are also seeing that there are more complex aortic patients coming forward, which includes Bentall procedures, patients with aortic regurgitation and also those with bicuspid valve disease. Now we also see growth taking place in mitral and tricuspid disease due to the halo effect of our transcatheter options that are now available to treat this disease state. It's bringing patients off the sidelines. So I want to show you this video, which features our real life surgical patients. They are younger, living longer and expecting more from life. You'll see that they're living active and fulfilling lives after surgery and they want to stay active without having to be on blood thinners for life, and they want valves that will last and help them the lifetime management of their disease. They are looking for the best solutions to improve their quality of life. I'm always inspired when I see how our patients' lives are being impacted with the use of our technologies. So let's talk a little bit about what we're doing in surgical to deliver on the promise for patients and physicians. So RESILIA tissue is the benchmark for valve durability. It's now on all of our flagship products in our surgical business, and you see it also on SAPIEN 3 Ultra RESILIA in our transcatheter portfolios as Dan mentioned earlier. To date, we have over 650,000 patients treated with our RESILIA innovations, and we have a breadth of data on RESILIA, approximately 20 studies involving 7,000 patients. And we're not stopping. We're going to continue to expand and innovate with our technologies using RESILIA tissue, as you can see on the screen, and you heard Daveen just mentioned previously. And we're going to continue to drive data generation -- long-term data generation that talks about the impact of RESILIA tissue on our patients. So our RESILIA portfolio is truly transforming patient lives around the world. Together, INSPIRIS, KONECT and MITRIS illustrate how RESILIA is doing just that. INSPIRIS is the leading surgical aortic valve globally around the world. And as mentioned, it has provided extended durability with RESILIA tissue. It is also the only surgical aortic valve with VFit technology that expands for future TAVR valve-in-valve procedures, which allows for best patient lifetime management. We also know that there is significant opportunity to treat patients with INSPIRIS around the world. Let me tell you about our patient Matsuo, you saw on the patient video. He's 74 years old and after receiving an INSPIRIS aortic valve to treat his aortic stenosis, he continues to be a marathon runner and he shares his journey of resilience and gratitude after receiving this aortic valve. So it's pretty impressive what our patients do when they're given a second chance at life. So let's talk about another innovation in our aortic portfolio. KONECT is the first and only ready-to-implant aortic valve conduit. We have seen significant growth in the U.S. in Bentall procedures since the launch of KONECT back in 2020. We also saw excellent clinical results presented at STS in January of this year, and we launched KONECT recently in Europe with very positive surgeon response for this technology that they've waited 5 years for based on the feedback that they've heard from their U.S. colleagues. Now KONECT, as I mentioned, is an ideal solution for patients that need Bentall surgery. And there's nothing more powerful than when you have a cardiac surgeon that chooses a technology that they believe in, not just for their patients, but for themselves when they become the patient. And that's exactly what Dr. Robertson did. So let's hear directly from him about his experience with KONECT. [Presentation]

So Dr. Robertson is based in Santa Monica. So he's obviously enjoying with locale and continuing to be active and walking on the beach, but his story really highlights the trust that clinicians place in KONECT, not just for their patients but obviously for themselves. So let's talk about another innovation on our portfolio MITRIS. So MITRIS has been specifically designed for the mitral position and it brings the durability of RESILIA tissue to these patients. It has also been designed to make implantation even easier for surgeons and better for patients. It is the leading mitral replacement valve in the U.S., and we launched MITRIS in China earlier this year and continuing the rollout of MITRIS in Europe where it was launched last year. And patient enrollment is complete in the global MOMENTIS study. So another patient from our patient [ Fidia ] Saowapa. She's a 51-year-old accountant from Thailand, who had heart disease as a result of rheumatic fever. She chose a MITRIS RESILIA valve with her doctor due to her active lifestyle and again, to have freedom from blood thinners. These patient stories highlight the impacts that our technologies have on the lives of patients around the world. So now let me share with you the data that supports our innovations and the experiences that these patients feel on a day-to-day basis. So one of our biggest data releases in surgical this year was a presentation of the 8-year clinical outcomes of those RESILIA tissue valves versus non-RESILIA tissue valves. And the numbers are impressive. There were approximately in this study, 1,000 patients at 8 years, where 99.3% of patients with RESILIA valves were free from structural valve deterioration and reoperation and showed excellent sustained clinical hemodynamics when compared to non-RESILIA valves. This means that patients can count on long-term performance and durability with RESILIA tissue valves. And we're not stopping there. In 2026, we will see bringing more clinical evidence to support our innovations. We'll see the landmark 10-year results from the RESILIA aortic pivotal trial study, and we will also have outcomes from the 1-year MITRIS study, which is the largest core lab adjudicated MITRIS study. And this is all part of our commitment to back up our innovations with robust real-world evidence. Now looking beyond aortic and mitral disease, as Daveen has mentioned, there's a huge unmet need in tricuspid regurgitation. In the U.S. alone, we estimate approximately 1.6 million people suffer from moderate-to-severe tricuspid regurgitation. As we mentioned, these transcatheter options to address this disease has now brought more patients off the sidelines seeking treatment that previously had no other options. So these patients deserve a full complement of solutions, and we, in surgical, are working hard to be able to do that. And that's where TRIFORMIS comes in. It will be the first surgical valve specifically designed and indicated for the tricuspid position. It's designed specifically for the unique anatomy of the tricuspid valve, making it easier to implant and improving outcomes for patients. And with more awareness and treatment options, we do finally feel that now we can collectively address this patient need, not just with transcatheter options but also for those that need a surgical intervention. And we are excited to say that we're planning to have TRIFORMIS rollout in the back half of 2026 in the U.S. So with INSPIRIS, KONECT, MITRIS and soon TRIFORMIS, you will see that Edwards offers the broadest portfolio of surgical structural heart therapies. And with this breadth, it means that we can provide the best solutions for more patients than ever before. Now our innovation pipeline in surgical is robust. We have multiple launches planned for the coming years from INSPIRIS, KONECT, MITRIS, as I mentioned, TRIFORMIS next year and next-generation valves, we are always looking for new ways to help our patients. We also are exploring new spaces like left atrial appendage exclusion to keep pushing the boundaries of what's possible to help meet patient needs in the areas and the procedures that we are in. So looking ahead, surgical in 2026 is projecting mid-single-digit growth in 2026. We expect increased RESILIA adoption and new product launches to help drive this growth. And the number of aortic and mitral patients is growing. And with new transcatheter innovations that are bringing more patients to seek treatment. These patients, some of them are resulting in having a surgical intervention because they have -- they're not capable to be -- or excuse me, not able to be treated through transcatheter options. We feel very confident in our outlook and our ability to deliver innovative surgical technologies in structural heart for patients and for physicians. So thank you so much for your time. And I want to bring back up to the front, our CEO, Bernard.

Excellent YJ. Thanks also to Daveen and Dan. Great presentation for TAVR and TMTT. So what I want to do now is a brief recap about what you just heard about our core innovation, TAVR, TMTT and Surgical. So in TAVR, SAPIEN has set a global benchmark right now. And this is enabling us to enter a new era of proactive disease management. Dan talked about that. We have so many catalysts still there. In TMTT, this comprehensive portfolio. We had 2 waves of growth in the past. Daveen talked about that. We have 2 new ones in the U.S. starting in 2026. This is also enabling us to have -- to start this personalized therapy for patients and expanding patient access. In Surgical, new therapies and leading innovation to transform patient lives globally. Across all, what you can expect from us is we will continue to partner with physicians, the way we do it in a very high-quality manner, with medical societies, regulators, payers, patients to clearly innovate, big innovation, advance science and ensure that patients have access to Edwards therapy, best therapy in the world. So we have had 65 years of success. And I trust you still saying we still have a lot to come here. I don't believe I have seen a cycle -- like the cycle we are here with so many catalysts, new technologies, new therapies, new indication, addressing patient group that have no other solutions today, where we are going to create new markets. So it is pretty exciting to see this very unique innovation strategy in action. We love all of this. We are very committed where we stay behind it. At the same time, we see many, many emerging opportunities to be able to reach more patients and to complement our portfolio. So you are going to hear more and we are going to start with Dan and the TAVR AR opportunity. Dan?

Thanks, Bernard. Thank you so much. Well, it's early and the disease is not well understood, and there is a ton to learn, and it's going to require a significant commitment, and this is aortic regurgitation, but it is a very large clinical unmet need, and it sounds like the perfect challenge and opportunity for Edwards Lifesciences. I want to start with some basic education between aortic stenosis and aortic regurgitation. I think it's important. So aortic stenosis is a narrowing of the valve. It's a restriction of the opening of the aortic valve. This is because the leaflets are calcified. They're heavily calcified and their movement is restricted, right? So you have less oxygenated blood going to the organs of the body and the left ventricle has to work really hard to get the blood out to those organs because the narrowing is so restricted in the opening that the leaflets really struggle to open. That calcium on the aortic valve is the perfect thing for a transcatheter valve to anchor on, right? That's what makes it so compelling and so successful. It's very, very different with aortic regurgitation. We have incomplete closing of the aortic valve. The leaflets are typically healthy and you get a dilated valve. The annulus moves away from itself and so the leaflets can't close properly. So you get this hole and now you've got backflow. So now that oxygenated blood is not getting to vital organs because it keeps coming back on itself, you get this leak and the heart has to work harder and harder to get the blood to those vital organs. And so you get the problem -- a similar problem just in a different way, but you don't have that calcium anymore to anchor on. And so transcatheter technologies need to be very different to find a solution for these patients. You know what's for sure, it is a deadly disease, and it goes largely untreated. It's not as easy to diagnose by echocardiography. And so it is typically underdetected, it's definitively under referred and it's definitively undertreated. And just like aortic stenosis, if untreated, very, very high mortality, unlike aortic stenosis, not that many options for surgery than surgery. And so we believe that despite early and despite not well understood and despite a lot of work ahead, this is the perfect place for Edwards Lifesciences' talented team and deep expertise to go after this important disease state, meaningful clinical unmet need, and we think that this will provide an important growth opportunity for us in the mid- to long term. We like our strategy a lot. Our intention is to run hard at this with complementary technologies. We believe complementary technologies will enable the broadest amount of patients to be treated, right? It's, again, early days. We -- with J-Valve, which is now under the Edwards name, [ SOJOURN ], this is in clinical trial. This is our pivotal trial, our JOURNEY pivotal trial is enrolling. Everybody knows that we entered into an agreement to acquire JenaValve. That is under FTC review, but we remain confident that we're going to get a positive ruling there. And assuming that ruling is positive, then we would expect that to close in Q1 of 2026. So it's early. And just like we did with TAVR AS, we're going to have to apply the same playbook. Committed leadership, evidence generation, continuous innovation to try and advance this therapy for patients. The opportunity here is going to be in the work. But we believe with a large clinical unmet need and our expertise, we're confident we can make a meaningful impact on these patients, and we're confident that this will provide a meaningful growth opportunity for us in the mid- to longer term. So thanks for listening, and I'll hand over to Todd Brinton, who's going to tell us more about heart failure and interventional heart failure. Thank you.

Thanks, Dan. All right. Good morning, everyone. I'm here to talk to you about structural heart failure. So -- all right. So this is a huge growing epidemic due to the aging population and current health trends and the impact is substantial. So as a reminder, when we talk about structural heart failure, we're referring to the large number of patients that have symptoms of heart failure due to either valvular or non-valvular structural heart disease. It's the large number of heart failure patients out there. I'm here as the Chief Scientific Officer, but also as a practicing interventional cardiologist for almost 20 years, and I've had the responsibility for the care of patients with heart failure. So keeping in mind, as patients go untreated, they enter a devastating downward spiral as highlighted really by this graph here, with their quality life deteriorating rapidly and ultimately leading to hospitalizations as highlighted by these red dots. Now as the disease progresses, heart failure hospitalizations become more frequent, which not only impacts the patient, but it impacts the entire health care system. But let's talk about the why. It turns out that the key driver of this decline is increased intracardiac pressure. As patients progress through the disease, intracardiac pressure rises, and this mirrors the decline in quality of life. These 2 things run in parallel. Luckily, we now have evolving solutions to address this challenging problem. One of these is mechanical pressure reduction with technologies like our investigational APTURE left atrial to coronary sinus shunt. There's also implantable sensor therapies that help patients better manage their disease. So let's go a little deeper on pressure sensor management. The cardiac pressure management is changing the way the patients interact with their disease. What you're seeing here in this diagram is the lowering of pressure through the use of medications with feedback from a pressure sensor management strategy. You can see as pressures get lower, patients improve. In fact, there is clear evidence of improved outcomes for these patients. In fact, a recent meta-analysis published in the Journal of the American College of Cardiology just demonstrated a very, very large reduction, a 36% reduction in heart failure hospitalizations at 1 year. And for the first time, a 25% reduction in mortality in patients with heart failure with reduced ejection fraction at 2 years, pretty impressive. But what if we could do even better. So the growth of our implantable heart failure management business will offer a comprehensive toolbox of pressure sensor management solutions. I want to draw your attention to the diagram on the left, the heart, the cardiac structures and the great vessels. What you see by the blue dot is the pulmonary artery. Interesting enough, this is exciting that we can monitor pulmonary pressures and improve the management of patients. But what if we expanded to the red dot, direct measurement of intracardiac left atrial pressure may yield even better results. In fact, every cardiologist was trained on intracardiac pressures, including myself. Any question we had, we took the patient to the cath lab and did a right heart cath. So these direct pressures are how we manage our patients. It's how we make better decisions about our care. So as Bernard stated earlier, we've built a strong foundation in structural heart disease, pioneering innovations in valvular heart disease. We have deep and extensive knowledge of delivering therapies into the structural heart. We know how to deliver. We know how to develop implants. So in addition to the management of left heart failure we just discussed, there are lots of emerging opportunities. This number -- a large number of patients with unaddressed patient disease. We're driven to continue solving large complex unmet needs with our pioneering transcatheter innovations and our trusted partnerships with clinicians. We're confident in our abilities to tackle these expanded opportunities to improve patients' lives. But let me reiterate the burden and the opportunity. Intervening early with the right solution is critical. By meeting patients where they are, we're shifting the trajectory, altering the course of structural heart disease for patients. We have an opportunity here. We can give patients a new outlook on life. We can keep them out of the hospital, and we can give them quality of life that they want and they ultimately deserve. That's what the strategy is here. So with that, I'm going to pass this on to my colleague, Diane Gomez-Thinnes, who will go through IHFM. [Presentation]

Well, hello, everyone, and I'm pleased to be here to share our progress with the newest addition to the Edwards portfolio implantable heart failure management. At Edwards, we are out to shape the future of heart failure management. We seek to address the unmet needs of a significant number of patients at risk for hospitalization and transform the standard of care by empowering not just clinicians but also patients with data. Our strategy, which includes investment in technology and evidence will enable this data-driven management approach to scale beyond a historically narrow group of early adopters. Heart failure is a major and growing burden that requires a novel and a scalable solution. Over 1 million patients in the U.S. are hospitalized due to heart failure each year, and that volume continues to grow. Patients face worsening quality of life, including physical limitations, emotional distress and social isolation. And the risk for rehospitalizations and mortality is high in this population. And as Todd mentioned, the cost of care is quite significant. Further, the strain on the heart failure cardiology community will expand as only about 1,500 advanced heart failure specialists are in the U.S. working to change the trajectory for these patients. The patient and the health care provider needs are clear and daunting, but there is progress. Patient access to important pressure sensor-guided management solutions has improved. The NCD that was released earlier this year truly removes a major barrier for U.S. heart failure patients. This and the mounting clinical evidence truly support these innovations. Cordella is our pulmonary artery pressure sensor solution, which begins in the cath lab with a short outpatient procedure. The sensor connects the patient to the Cordella platform. Patients are engaged and informed, finding the system easy to use. They prefer the unique seated position for readings, and they pay attention to their daily trends. Data flows to the clinical care team now feeding a cycle of data-driven proactive heart failure management. And this patient experience leads to a high level of long-term engagement and therefore, compliance. Patients will also often change behaviors based on their data. In our early clinical experience, 1 in 2 patients made lifestyle changes. And lastly, our growing volume of data will continue to provide us valuable insights to fuel further development for solutions for both patients and clinicians. Cordella is a strong first differentiated offering from IHFM. Empowerment of patients and providers requires a user-friendly platform that facilitates scalable and engaging workflows for both the clinic and the home. And the system's comprehensive and actionable data provides confidence and peace of mind, while medical therapy decisions are being made. And this management approach should replace today's more reactive symptom-driven standard of care that U.S. patients see today. The patient-centric experience is a differentiator. A patient's ability to see their own pressure and vitals data paired with the ease of ceded reading leads to strong and sustained engagement and compliance, putting some control back into a patient's hands. And the patient behavior modifications that we see today are a positive step toward a future where a patient can self-manage and adjust medications without waiting for a physician to take action each time. Our path to transforming heart failure management is to establish a new data-driven and patient-engaged standard of care. We are executing on a road map of innovation that includes novel implantable pulmonary artery and left atrial pressure sensors for both indirect and direct measures of pressure and a platform that aids in decision-making and streams workflows. We are committed to building the evidence to inspire adoption and demonstrate the value of data-driven management, an approach which now engages the patient in their own care and moves the field from reactive and descriptive assessments to predictive and proactive care. 2025 has been a foundation-building year for IHFM, and we continue to make progress expanding new capabilities in our transition as a commercial business. We are executing on a technology road map, simplifying the Cordella procedure and enhancing our software platform. And we've added to our portfolio with a new left atrial pressure solution, V-LAP. We are growing the evidence for the Cordella platform with new long-term data demonstrating sustained benefit and impressive levels of patient engagement. And we are actively enrolling in 2 studies, our PROACTIVE-HF 2 study for Cordella and the VECTOR-HF II with V-LAP. We are pleased by the favorable feedback we received from physicians and their patients, who are choosing Cordella. We are collecting learnings from our current Cordella early user evaluation phase, which informs our next stage of commercialization. And looking forward to 2026, we will continue to develop and deploy new features to enhance the Cordella platform. We're expanding our data sciences capabilities and building both near-term and longer-term data for both Cordella and V-LAP. We will continue to partner with our customers to unlock scalability and maximize the impact on patient care. Transforming this category will take time as awareness grows and our solution evolves and takes hold. We are excited for the future, and we are committed to building this new patient engaged standard of care in heart failure management. Thank you all. And with that, we will move into a 15-minute break. Thank you. [Break]

All right. Good morning, everyone. For those online, thanks for rejoining us from a break. So I'm Scott Ullem, and you've heard a lot this morning about our plans for Edwards Lifesciences. I'm going to bring that together through a financial lens and talk about how our objectives and our plans reflect and resource Edwards corporate strategy. So financial outcomes a result, of course, the plans that we have in place and the investments we're making to generate the results that you'll see in the financial profile now. So it's really 3 elements. The first is, of course, strong organic top line growth, and we've got this portfolio of structural heart therapies that support the top line. The second is healthy and expanding margins. So starting with gross margins, which are high-impact, high-value products made efficiently, combined with operating expenses and operating margin that will expand 50 to 100 basis points constant currency in the years ahead. And the combination of those 2 yield a leveraged earnings per share profile for the next -- as we look forward. The third piece, of course, is smart capital allocation. Our capital allocation priorities have not changed, and we'll talk about that in a few minutes. So starting with sales. Again, this is a portfolio now of therapies that contribute to Edwards growth rate on the top line. It's not just one business. It's multiple different therapies that contribute to our sales growth. That sales growth is fueled by research and development. It's fueled by a lot of different elements, but none more important or noticeable than R&D. So the reason why we expect to grow 8% to 10% in 2026 is partly due to investments in research and development that we made 3 years and 5 years and 10-plus years ago. The third piece is sustained leadership position supported by evidence-based impact and value to patients and clinicians and health care systems and payers. So to give you a closer look, this year, we expect to be at sales in the range of $6 billion. So we've seen significant growth over the last several years. And the composition of that is 60-40, so 60% U.S., 40% OUS. It's this global footprint that positions Edwards to bring therapies to patients around the world. And we now have resources in place in all major regions to support the company's growth. So you heard a lot about the sales plans and our growth opportunities across our existing innovation, core innovations as well as our emerging opportunities for patients who are addressed today, but then among the 20 million structural heart patients, those of whom are unaddressed today and where we've got an opportunity to bring therapies to benefit those patients in the years ahead. So the second element is our margin profile. So we've got strong gross profit margins, as you know, again, by bringing high-impact, high-value therapies to market after manufacturing and distributing them efficiently. And it's a big part of our operations model, and I think it reflects our world-class global supply chain and quality organization. We're also, at the same time, expanding our field organization. So having Edwards personnel in the field close to providers and operators is really an important part of our strategy, and we invest to make that happen. We're going to continue to invest to bolster that field force. And the third piece, of course, is continuing to invest on a prioritized basis in research and development and other areas that can really help fuel our growth, but fuel it in a way that also gives us an opportunity to improve our operating margins over time. So here's a walk across of the current 2025 expected operating margin of 27% to 28% to next year's estimated operating margin of about 100 basis points higher. It starts, of course, with strong organic revenue growth and those increased sales generate increased profit. The gross margin level, we'll see volume efficiency. So scaling our business, being able to manufacture therapies and technologies at higher volumes gives us an opportunity to manufacture at lower rates. We're going to continue to see leverage from our manufacturing footprint. We've got facilities across all 3 of our key production regions, Europe, the Americas and Asia Pacific, and we'll see leverage from those manufacturing facilities and that network that we have in place to produce implants and delivery systems. And for those of you who were here last night, you got to look at some of those delivery systems and how we design those for ultimate commercialization. New product introductions end up being a drag on gross margins in the short term. So when we're making technologies and introducing new products generally at lower volumes, that's a drag on gross profit margins, but it's swamped by the benefits we get from mix and improving volumes in existing therapies. And of course, annualization of tariffs will also be a little bit of a headwind in 2026. We had some tariff expense in 2025, but not for the full year. We are planning that we'll experience that for the full year in 2026. In terms of operations, similar to the efficiencies that we get on the production side, we also get efficiencies in general and administrative spending, as the business continues to grow and as we support this global footprint with general and administrative activities. We're going to continue to prioritize research and development initiatives. So we're continuing to grow research and development spending but with pretty disciplined prioritization of what platforms we're investing in, what platforms we're accelerating and what platforms we may be deprioritizing or deaccelerating based upon progress that we make across those different R&D platforms. Foreign exchange ends up being a little bit of a benefit to operating margins this year. About 30 basis points of operating margin increase will be from foreign exchange flowing through the P&L. And we're going to continue to invest in that field force, I mentioned before, to really drive patient access initiatives and support patient activation initiatives as well as continuing to grow the business with the right infrastructure, the right personnel, the right resources in the field. And then finally, new investments. So making investments in emerging opportunities like the acquisition of JenaValve is going to be a short-term headwind to operating margins. But you roll all that up together, and we're expecting about a 100 basis point expansion in operating margins in 2026. So research and development. I mentioned before, prioritizing R&D is an important part of our strategy. And right now, about 3/4 of our research and development spend estimated to be $1.1 billion in 2026 comes from the generation of scientific evidence. So spend relating to clinical trials, clinical affairs, regulatory affairs, medical affairs are all in -- are part of that research and development budget. The other 1/4 is sustaining research and development. So R&D to support our existing therapies, and that's an important part of what we do on the engineering side in research and development. You can see on the right hand, what I mentioned before, which is research and development spending continuing to increase but at a lower rate than the top line will increase. So the result of that is we have margins that went from 19.4% last year, estimated 18% this year, declining to 17% or so in 2026. So we're pleased with that trajectory. It's part of this 50 to 100 basis point operating margin expansion that we've guided to. So here's how that translates in terms of earnings per share. This year, $2.56 to $2.62 is our guidance for the full year 2025. The biggest increase, of course, in earnings per share next year is core business operations offset by some of the additional investments that we're making in emerging opportunities, but the net of that gets us to $0.29 to $0.35 in EPS. Tax is a little bit of a headwind. We're increasing our tax rate guidance for 2026 by about 100 basis points on the bottom end and the top end to 16% to 19% and the impact of that is around $0.03 at the midpoint of the range. The combination of interest income, share count and foreign exchange ends up being about flat by the time we get down to earnings per share, which is unusual. In the years past, we've had a lot of impact from FX starting at the top line and flowing down through the P&L. We don't see that based upon current rates. Of course, they're changing every day. But based upon current rates, we're seeing pretty nominal impacts through the P&L from FX. So that gets us to $2.80 to $2.95 for 2026 and then growing in 2027 and beyond, leverage to the top line. So assume on average, constant currency around 10% top line growth, expect that we'll have bottom line growth -- EPS growth in excess of that level. Okay. Finally, strategic capital deployment. So there are a couple of different elements to it. Of course, the first piece is investing to support our growth and specifically including PP&E. So our production capacity in these production facilities around the world, including our new facility that we're building right now in Valencia, Spain, consumes a lot of that capital that we are generating through cash flow. The second piece is external investments. So Edwards is an active acquirer and an active investor to supplement our internal work that we're doing to develop new therapies. And those investments come in the form of minority investments, seed capital. We invest in intellectual property. We buy options to acquire companies based upon certain milestones that they may meet in the future. And so that's an important direction for some of this cash flow that the company generates. The third piece is returning capital to shareholders. We have a consistent track record of buying back stock. I'll show that in just a second. So here's a closer look at capital spending. We're expecting around $280 million in CapEx in 2026, a little bit of an increase over our expected 2025 levels. CapEx is a little bit lumpy. It doesn't fall into 90-day periods perfectly, but overall, we're spending about $0.25 billion a year on capital. Where are we investing? Half of that comes in our production facilities and global supply chain and the balance is in infrastructure, like you've seen around here and the research and development investments that we make to help support the company's growth. So share repurchase, I mentioned, is an important feature of how we manage our balance sheet and how we allocate our capital. And you can see over time, we've done a pretty aggressive job of buying in our share count. We first prioritize offsetting the impacts of incentive compensation and performance-based stock awards. We want to offset that dilution, but we're also looking for opportunities regularly to bring down the net share count over time. And you can see we've done that. You should expect that we will continue to buy back stock. We have about $2 billion of authorization remaining, and we're always looking for opportunities to do that at the right time. So bringing this all together, here's a comprehensive look at our financial guidance for 2026. You can note on the upper right-hand corner, what I mentioned before, which is the FX impact to sales is nominal this year. The $6.4 billion to $6.8 billion of guidance incorporates only a little bit of foreign exchange impact, hardly worth mentioning. And we're expecting gross margins similar to 2025 in the 78% to 79% range with operating margins 28% to 29%. About 30 basis points of that is the benefit of FX. So I think net 70 basis point range of operating margin expansion in 2026. So overall, our financial strategy, these objectives and plans that I've taken you through are designed to create enhanced shareholder value. So this combination of double-digit top line growth, around 10% on average constant currency going forward, plus operating margin expansion, yielding leveraged EPS growth, we think, is the right financial formula to support the company's growth and to provide a great opportunity for investors. So with that, we'll wrap up the financial presentation. Bernard is going to do a wrap-up for what you've heard this morning, and then we'll take a quick break before Q&A. So Bernard, over to you.

Thanks, Scott, and to all of our presenters this morning. So let me do a quick recap about what you heard this morning. We are this pretty amazing company, committed to delivering sustainable, differentiated growth with a very clear strategy, bringing big innovation, high-quality science to solve large and complex patient needs. And all of this is resulting in creating and defining new therapeutic area for us, and for patients. And we are uniquely positioned to shape the future of Structural Heart with this most comprehensive portfolio of differentiated therapies. Many innovations that we talked about you this morning are first of the kind, and designed to help patients live better and longer. I started my presentation this morning talking about how special we are as a company. And what makes us special is the combination of our success as a company over the years, our very unique strategy, solely focusing on Structural Heart, taking risk, having a long-term commitment, and our culture, caring about patients every day. We have 16,000 employees globally across about 100 countries, a little bit more. And every day, they wake up, they go to work and they care about patients. We are also very committed to strengthening the communities wherever we are present, wherever our employees are living and working. Our Board of Directors, very diverse background, highly experienced, guiding the company to the best of their ability. They are focused, they are engaged, they are present, always available. I'm very thankful of having this kind of Board of Directors around me. To recap our financial outlook, 2026 will be another year of distinguished performance after having had a strong 2025. What I like about where we are, it is going to be led by our core innovation across TAVR, Surgical, and TMTT. It is not just the one, it is all of them. We have also many catalysts that are going to have a big impact in '26, '27 and '28. As a matter of fact, for '27 and beyond, we have a very strong P&L, very healthy balance sheet to fund our very unique innovation strategy. So in summary, we are very well positioned for sustained and differentiated performance. Our strategy is clear, create long-term value for patients, health care systems and shareholders by focusing on structural heart disease, solely focusing on structural heart disease, solving large and complex patient needs and pioneering new therapies. So in summary, this is Edward's innovation with purpose, powered by science, centered on the patients. Thank you very much for listening this morning. I think as a team, we prepared this morning to make it comprehensive and exciting for all of you. We are going to take now a very short break of about 5 minutes to prepare for Q&A.

Who is ready for some Q&A? All right. Good. We are, too. So in front of you, we've got all the speakers that you heard from earlier today. We've got a lot of great analysts with a lot of great questions. We're going to try to get to as many of you as possible. [Operator Instructions] At the end of the Q&A session, Bernard is going to make some brief closing remarks, and then we're going to go to a patient video, and then I'll come back with some logistics in terms of what's next around the lunch. So with that, first question, maybe, David.

David Roman from Goldman Sachs. Maybe we could start on the TMTT side. Clearly, a lot of drivers here. But as you put the 2026 guidance into context of the $2 billion in 2030, it starts to put a lot of onus on those outer year periods. So can you maybe just walk us through how you get from what it will roughly be $200 million of incremental growth in '26 to something that needs to be multiples of that as you look forward?

Sure. Let me give you a little background. Thanks so much for the question. So first, at the highest level, as I mentioned probably in my last slide, if you look at TMTT next year, most of the growth and most of the revenue is driven really by our first 2 products, PASCAL mitral and EVOQUE. So I'll first start with strategy. And then now you see next year in the U.S., the next 2 growth drivers, both SAPIEN M3 in the beginning of the year, and in Q4, PASCAL tricuspid. So the first 2 growth drivers are really a lot of that $740 million to $780 million next year. And we have 2 new growth drivers coming in after. And so then if you look now kind of at the numbers, from 2024 to 2025, we grew about $180 million, $185 million year-over-year. And next year to a midpoint, it's growing about $220 million. So it's increasing. We expect that to continue to increase each year, because ultimately, those core patients are coming in for PASCAL mitral, and EVOQUE, and then we have these kind of new growth drivers adding in. So you can imagine that in the incremental dollar growth from year-over-year, that number continues to grow, and to help us get to what we feel comfortable about saying is reaching that $2 billion in 2030 overall.

Travis?

I wanted to ask on the PROGRESS trial. First, last year, I think the outlook slides had PROGRESS as the TAVR growth driver, and it wasn't in this year's slide. So I don't know if that was the reason, will ask you on that? And then how long do you think it will take, if the data is positive, for this to impact TAVR growth? And do you need guidelines to change? And how much do you have in your targets for Moderate?

Do you want to take it, Dan?

Yes, I'm happy to start, right? So PROGRESS, first of all, excited about the opportunity that we have with PROGRESS, right? Right now, that trial has finished enrollment, closed enrollment, but we're still in the follow-up phase. We think that if we follow that normal path, we'll be ready to present at TCT next year. So we're blinded, completely blinded to what that data looks like, et cetera. And I think in terms of impact, I mean, clearly, it's an independent layer of growth for us, right? It's definitely a catalyst more for mid, long term. But when I think about these indications, particularly asymptomatic and Moderate indications in the future, very different indications to what we had with high risk, low risk, intermediate risk. These had a predicate. These were like the predicate existed for surgery, the referral patterns in place. With these newer indications, that predicate doesn't exist. And so the process of education, democratization of all this is a completely different muscle that we have to do upstream. That being said, we already see the impact of this type of data, looking at asymptomatic and looking at what it's doing for proactive disease management. So we anticipate the impact of Moderate will be quite similar, not a light switch, but a durable impact on our growth over time. And so that's kind of what we're looking forward to, and we're looking forward to the opportunity once we know more about the data.

Dan, Moderate was one of the fastest enrolling study, no?

Well, I guess we know 2 things about Moderate. One is it enrolled very fast, right? It enrolled ahead of expectation, which kind of gives us a good sense of what the market opportunity is, what the unmet need is for these patients. So that was encouraging. It enrolled very fast. The other thing that we know is we have a continued access program with the PROGRESS trial. So patients continue to be enrolled in a continued access program as part of that clinical trial. And the demand in that is still very, very strong. So they're the only 2 things that we know. And as far as what the data is, we learn more about that at TCT.

Shagun.

Shagun Singh, RBC Capital. I just wanted to touch on guidance and get a better sense of what's factored in. How did you arrive at the 8% to 10%? As you think about the momentum you have in 2025, how should we think about that in that context? Is it more of a base case and it's still early in the year? And then also on EPS, the JenaValve dilution, you're still having conversations with the FTC. Why was that the right approach to guidance? And what is factored in for '26?

Yes. Thanks for the question. So on sales, this year, in 2025, we started at 8% to 10% guidance as well. And we think that's the right way to start for 2026. we're optimistic about '26. We think it's going to be a strong year. But we're also cognizant of the fact that it's early. We're still in 2025. There are risks that can enter into the equation. And so we're going to be monitoring those carefully. We think that 8% to 10% is the right starting point for 2026. We always encourage people to model to the midpoint of our guidance ranges. And so that's at least where we are at this point. I think in terms of earnings per share and JenaValve, we could have taken a couple of different approaches. Was it in? Is it out? What we decided to do was make some assumptions about what the impact of owning JenaValve could be depending upon when we close it, depending upon what we learn once we own it and what integration plans we would develop. And so those are included in that $2.80 to $2.95 guidance for EPS next year. Now when we find out the result of this process that we've been in, we will provide an update on what the earnings per share impact could be. We're hopeful that we are closing that acquisition. If we do not close it, we will increase earnings per share guidance, at least for that isolated element of EPS in 2026, and we would talk about what the amount is when the time comes.

Robbie?

Robbie Marcus, JPMorgan. Bernard, you spend significantly more than anyone else on Structural Heart, and we were talking about this last night. You're starting to see, on TAVR, a little bit of separation, Edwards starting to gain share. You're taking the majority of market growth in mitral repair. You're splitting the market in tricuspid right now, and you still have a repair product to come. So how are you thinking about Edwards investment versus opportunity versus competitors over the next not just 1 year, but 3, 5 years? Is there still a substantial amount of separation yet to come from all the innovation that you're putting through? We saw the innovation center last night. How are you thinking about that?

Clearly, we want to bring best innovation and providing high-quality support to the clinicians to treat their patients the best they can. This could result in some share gain, but it's not our priority. We like it. We enjoy it. Our priority is truly about serving large unmet patient needs. I talk about this many unaddressed patient group, where here we have an opportunity to again create new markets to again pioneer therapy for many patients. And I think I talked about 6 to 7. This is going to represent multiyear of growth. So for sure, because we are so committed to innovation, our innovations are usually highly differentiated. They bring value also to the entire health care system, including taxpayers and shareholders. But in my mind, the uniqueness of our strategy is to be able to tackle this large growing unaddressed patient population, where certain we can increase the number of patients we are going to help in the next 5 to 10 years. So this is what you are going to see from us. And I'm glad you started feeling it. We feel it. This is what I said earlier this morning. I don't believe we have been in such position in a long, long time with so many catalysts, so many new therapies, where we are pioneering things in addition to having great technologies.

Joanne?

I want to just confirm the dilution from JenaValve is $0.10. I think that's what it originally was supposed to be. Is that what you have dialed in for '26?

No, we didn't announce what the potential dilution could be. Last year, when we talked about the potential impact of JenaValve, we said for half the year, it would look like $0.05 to $0.10. So if you were to extrapolate that and say, well, for the full year, if we were to close on January 1, that would look like $0.10 to $0.20. That's a big range. And we're not sure, when we do get approved, if we're going to close on date X or date Y, which is why we have some assumptions in that $280 million to $295 million, but we are not quantifying them at this point. Again, once we learn the decision, we'll provide more information about what the impact of that acquisition will be.

And then my real question has to do with the NCD, which it looks like it's quite specific. You expect it at the end of 2026. What are the steps to that? Because I know many people in this room will be tracking that and expectations for it.

Yes, I'll take it. So the very first thing is they have to open -- they have to reopen -- the CMS has to reopen it publicly, and then it goes into 2 phases of public commentary period, right? So as soon as it is opened, there's the first phase of public commentary period, and then they close that period, and then it goes into another phase where they announce a draft of the NCD, and then it gets reopened for public commentary, right? And then it closes again and then they announce the final. And that process is variable, and it can take typically up to 12 months. Sometimes it's been a little bit earlier than that. And sometimes it takes longer depending on if data is required or there's more controversy. So like that's the typical period. That's what we put into our assumption. So assuming that it follows the normal process, which we definitively think it should, then the sooner it opens, then the sooner it closes, and that's why we think that it's sort of towards the end of next year. It's a high priority. We know that. It's been communicated that it's a high priority for them, but timing is uncertain. The staff at CMS is stretched, and there's a lot going on with the political environment, but we know that it's a high priority. So we're looking forward to opening as soon as possible.

Chris?

Chris Pasquale, Nephron. Bernard, on your growth catalyst slide, you had aortic regurgitation out in the '28 and beyond category. I'm curious how that sort of squares with the idea that you guys still expect to close the JenaValve deal. Is that '28 and beyond based solely on SOJER? Or does that assume that Trilogy could be a commercializable product?

No, what I wanted to represent is not necessarily -- especially when it is a completely new therapy, not necessarily when we are going to start treating patients, but more about when we are going to start feeling an impact to the Edwards top line. So which is why let's assume we closed JenaValve in 2026, 2027 will be a year of, obviously, acceleration, fixing a number of things, starting bringing this to patients. The true impact to revenue, we will start to feel it in 2028 and beyond. So I wanted to be very balanced in the impact of the catalyst, especially when it is completely new. When it is a new technology, it is different. Let's say, you have PASCAL TR, for instance. At the time of launch, we are going to feel it. So it depends what's existing and what's new.

Larry?

Larry Biegelsen, Wells Fargo. So Dan, I wanted to ask about X4. Just if you could please talk about the improvements you're making to the valve and the delivery system. Any color on the additional clinical data? And it looks like you're still expecting -- you're expecting approval in 2027 from what I can tell from the slides. Can you comment on that, please?

Yes. We don't know when we're expecting approval, because we haven't laid out an approval pathway yet. We've closed -- the ALLIANCE trial completed enrollment at the very end of last year, and that's going under clinical follow-up, now it's a 1-year endpoint, right? So we kind of haven't worked through the data of that yet. But this is -- we're so excited about X4. I mean it is a complete game changer and a very different platform to S3 with this variable sizing feature, and has the real opportunity to change how we personalize our sizing to patients. And we bring a lot of other features, which physicians are quite excited about. But you learn the most when you get into clinic, right? And when we go into clinic, in clinical trial, this time with the ALLIANCE trial, we've got engineers there, we've got clinical specialists there, and we're seeing with our own eyes what is happening with the device. And this is where the innovation process really accelerates. We've set a really, really high bar with S3, and that gets higher with S3UR. And so when the engineers have come back and said, "Hey, I think we could do this. I think we could do that," which they do all the time, then it comes down to a decision, are you freezing something or are you adding those sorts of things? Do you want it in next-generation device or in your first generation? We've decided to take a couple of elements which we think are quite meaningful and sort of put them into the first-generation X4 device. Because it's a completely new platform, we're probably going to have to get more data on that to satisfy FDA, et cetera. And so we're planning to do that in 2026. And hopefully, that answers the question.