EW - NYSE

Greetings, and welcome to Edwards Lifesciences Fourth Quarter 2025 Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please note that this conference is being recorded. I will now turn the conference over to your host, Jerrianne Sarte. Thank you. You may begin.

Good afternoon, and thank you for joining us. This is Jerrianne Sarte, I am the incoming Senior Vice President of Investor Relations. With me on today's call is our CEO, Bernard

Thank you, Jerrianne, and welcome, everyone. I am pleased to introduce Jerrianne Sarte as our new Head of Investor Relations at Edwards Lifesciences Corporation. Jerrianne has an extensive background in medtech and as a leader in our global finance organization, prior to moving to this new position. You will be seeing and hearing from her going forward, and I know she looks forward to getting to know you. Now let me turn to discussing Q4 and 2025 results. We delivered a strong quarter growing at 11.6% and a strong full year 2025, growing at 10.7%. This is the result of our differentiated strategy. With a clear vision around three key elements: focusing solely on Structural Heart, solving large, urgent, and very complex patient needs, and pursuing unique opportunities to innovate and lead. This is only possible due to our deeply experienced teams, their excellent execution, and their commitment to patients worldwide. With our achievement in 2025, we are entering 2026 with strength and momentum globally. With many growth catalysts in each area across the company. Starting with TAVR, there is a renewed focus on SAPIEN across the healthcare ecosystem. Led by the seven-year Partner 3 and the ten-year Partner 2 data, which confirm the long-term durability and proven valve performance of the SAPIEN platform. This data presented last October at TCT reinforces the confidence physicians and patients have in Edwards Lifesciences Corporation's TAVR, and sets a new clinical benchmark for safety, efficacy, durability, and lifetime management of patients. In addition, the practice-changing early TAVR trial is resonating with the clinical community starting with the guideline changes in Europe. Together, all of these will have a lasting impact on the continued expansion of the SAPIEN platform globally. Continuing with TMTT, growth is fueled by a comprehensive portfolio of repair and replacement therapies, and strengthened by new options for patients. These include the launch of SAPIEN M3, the scaling of EVOQUE, the upcoming introduction of next-gen PASCAL in Q4 this year, and the introduction of PASCAL for U.S. Tricuspid patients also in Q4. Together, these are significant advancements for mitral and tricuspid patients and represent large opportunities to achieve our $2 billion revenue expectation for TMTT in 2030. Overall, for Edwards Lifesciences Corporation in 2026, we have increased confidence in meeting our 8% to 10% sales growth guidance as well as EPS guidance. We are looking forward to an updated national coverage determination for TAVR, which may present a potential tailwind later this year. Recognizing that our impressive results in 2025 have set a higher bar for 2026, especially in the second half. Long term, we are well-positioned to execute our compelling growth strategy. And specifically over the next three years, we will be pioneering new therapies, launching next-generation existing technologies, as well as expanding indications to impact more patients. Our talented team of 16,000 employees creates, develops, and enables treatment of patients globally with a highly differentiated and complete portfolio of therapy to address aortic, pulmonic, mitral, and tricuspid valve diseases. We take very seriously the responsibility of investing in the development of safe and effective valve therapies with proven long-term durability. Valve technology requires dedicated focus and generation of world-class clinical evidence. That will continue to differentiate Edwards Lifesciences Corporation. I am confident that our technology will remain the first choice of clinicians to transform the care of their patients. Leveraging our experience, we are extending into structural heart failure and aortic regurgitation or AR. For the many patients who are not well served today. This will create additional growth opportunities and extend our Structural Heart leadership. In 2027, and beyond, we continue to expect average annual sales growth of 10% with constant currency operating margin expansion as we continue to address patients in need by advancing novel therapies to extend lives, improve quality of life, and provide greater impact and efficiency for health systems. Now, I will provide an overview of Q4 sales performance by product group. TAVR overall procedural growth in the quarter remained in the high single digit. And for Edwards Lifesciences Corporation, TAVR fourth quarter global sales of $1.16 billion increased 10.6% over the prior year. And slightly sequentially over a high Q3 which was inconsistent with typical summer seasonality. The Q4 performance reflected clinicians' elevated focus on SAPIEN therapy and proactive disease management of patients suffering from severe aortic stenosis. Edwards Lifesciences Corporation's TAVR procedural growth was comparable across the U.S. and OUS. And our average price and competitive position were stable on a global basis. While early TAVR studied severe AS patients without symptoms, we are encouraged by the impact this study has had on increasing the sense of urgency for the treatment of patients who have symptoms. A timely referral, evaluation, and treatment of patients with severe aortic stenosis is fueled by a large and growing body of evidence on the long-term outcomes of SAPIEN valves. Our position as the only TAVR therapy with an asymptomatic indication will provide additional benefits. Along with the potential of an updated TAVR NCD in the U.S. and Japan guideline evolution. These additive catalysts provide multiple layers of durable growth. In addition to the long-term data presented at TCT, more than 30 distinguished physician thought leaders published the first-ever AS global consensus document. This validates the movement away from the outdated practice of watchful waiting. And further supports the importance of guideline-based management of severe AS patients. Let me turn to some U.S. We saw intentional and urgent treatment of severe aortic stenosis patients. Fueled by a large and growing body of world-class evidence on the SAPIEN platform and the increased adoption of SAPIEN 3 Ultra Resilia. We are pleased that CMS formally opened the process to reconsider the NCD for TAVR. This decision has the potential to improve timely and equitable access to life-saving TAVR therapy. The initial thirty-day public comment period closed on January 14 and we look forward to the process continuing. In Q4, we expanded our partnership with the American Heart Association as the founding sponsor of the Heart Valve initiative. This new initiative is focused on timely diagnosis and treatment to save lives and improve care for millions living with heart valve disease. It is a multi-year program to elevate heart valve disease as a critical focus area for hospital systems. Through adherence to specific quality metric-based care. Expanded data collection, enhanced healthcare professional education, and patient engagement. In Europe, fourth-quarter results reflected healthy underlying TAVR procedure growth. As well as our consistent execution across the region. Updated guidelines from the European Society of Cardiology, and the European Association for Cardiothoracic Surgery are reshaping clinical discussions around proactive disease management, and reinforcing the role of TAVR for a broader patient population. We also continue to see modest year-over-year share improvement in several key countries. Strengthening our leadership position in the wake of a competitor's exit. In summary for TAVR, we are pleased with our strong Q4 results. And full-year 2025 performance. SAPIEN's growth globally was supported by rising clinical urgency for intentional proactive disease management. And long-term evidence demonstrating the proven durability and valve performance of SAPIEN. As we look ahead, we are well-positioned to continue the momentum and remain focused on driving our patient access strategy. Generating additional clinical evidence and delivering on our innovation pipeline to address the growing patient needs across the world. These strengths reinforce our confidence in Edwards Lifesciences Corporation's TAVR as a durable growth engine and a meaningful contributor to long-term value creation. Now let's turn to our TMTT product group. Our comprehensive portfolio of repair and replacement therapies offers meaningful opportunities to physicians, to best treat their mitral and tricuspid patients. This drove another strong quarter. With TMTT growing over 40% to $156 million. We were also pleased that for the full year, TMTT sales exceeded half a billion dollars. Continued global adoption of PASCAL and EVOQUE contributed to overall growth. Physicians continue to provide positive feedback on PASCAL's differentiated benefits for the treatment of their patients who need transcatheter edge-to-edge repair. With EVOQUE, we are expanding the number of centers and training more physicians while focusing on excellent patient outcomes. The recent FDA approval of SAPIEN M3 expands our mitral portfolio in the U.S. and represents the first transcatheter replacement option suffering from mitral disease. Similar to our other therapy launches, the strategic introduction of SAPIEN M3 is leveraging our proven high-value support model and focusing on outstanding clinical outcomes. We are initially opening sites that were previously in our ENCIRCLE pivotal clinical trials. And physician interest in this technology is growing. With PASCAL and EVOQUE growing globally, and now with the introduction of SAPIEN M3 in the U.S. and Europe, Edwards Lifesciences Corporation continues to deliver on our vision of offering a portfolio of therapies to treat more mitral and tricuspid patients. Overall, PASCAL adoption globally is delivering differentiated outcomes for patients. The introduction of NextGen PASCAL in Q4 will further distinguish this important therapy for patients who need edge-to-edge repair. The upcoming U.S. approval of PASCAL for Tricuspid patients will provide an enhanced therapy alternative. And the scaling of EVOQUE and launch of SAPIEN M3 will further advance treatment for tricuspid and mitral patients. This represents multi-layer growth opportunities, starting in 2026 and contributing to achieving $2 billion of revenue in 2030 and additional growth beyond. Finally, this year, we continue to expect sales in the range of $740 million to $780 million. In our surgical product group, fourth-quarter global sales of $254 million increased 2% over the prior year. The underlying fundamentals of our surgical product group remain strong while growth in Q4 was impacted by end-of-year distributor inventory adjustments in one country. Full-year surgical sales grew 4.3%, and for the first time exceeded $1 billion. We continue to expect mid-single-digit sales growth rate in Surgical in 2026 driven by continued adoption of our RESILIA therapies that offer extended durability of our surgical therapies. Including Inspiris, Connect, and Mytris. We were encouraged by new data presented at the recent STS meeting including strong one-year data from the MOMENTYS study. MOMENTYS is studying long-term durability for the Edwards Mitra system for surgical mitral valve replacement. And one-year results from the study demonstrated 100% freedom from SVD, impressive stable hemodynamic performance, and excellent safety. This specifically designed surgical valve customized for mitral patients will advance and improve care. We are also pursuing multiple new innovations to advance surgical solutions for patients. Including left atrial appendage closure, or LAAC. This is a new therapeutic area that is a complementary solution to specific valvular procedures and we are planning on a preliminary introduction of our new surgical LAAC technology later this year. In summary, we still expect to deliver our mid-single-digit sales growth rate guidance in 2026. And finally, we are looking forward to seeing ten-year data from our COMMENTS trial at the AATS conference in May. Studying long-term durability of our best-in-class resilient tissue. And now, Scott will cover the details of the company's financial performance. Thanks, Bernard.

Today, I will provide a wrap-up of 2025 including detailed results of our fourth quarter and guidance for the first quarter and full year 2026. We were pleased with our better-than-expected Q4 sales performance with strength across all product groups. Total sales of $1.57 billion grew 11.6% year over year. Our adjusted earnings per share was $0.58. This lower-than-expected EPS was driven by higher spending on patient access initiatives at a higher-than-expected tax rate. It is important to note that we have increased confidence in our 2026 earnings per share guidance of $2.90 to $3.05. Our GAAP EPS for the quarter was $0.11, which included one-time charges related to the GennaValve acquisition that did not close as well as litigation expenses. A full reconciliation between our GAAP and adjusted EPS for this and other items is included with today's release. And now I'll cover additional details of our P&L. For the fourth quarter, our adjusted gross profit margin was 78.3%, in line with our expectations. Compared to 79% in the same period last year. This expected year-over-year change was driven by additional manufacturing expenses related to the FAST expansion of new therapies. We continue to expect our full-year 2026 adjusted gross profit margin to be within our original guidance range of 78% to 79%. Selling, general, and administrative expense in the quarter was $603 million or 38% of sales. Compared to 35% of sales in the prior year. We increased SG&A spending in the fourth quarter to fund strategic investments in order to amplify patient access to therapy such as early TAVR education, investment in field resources, and the heart valve initiative. Some of this strategic spending was delayed from previous quarters in the year. Research and development expense was $268 million in the fourth quarter or 17.1% of sales. Compared to $271 million or 19.6% of sales in the same period last year. This decrease in R&D as a percentage of sales reflects our strategic prioritization of investments in our expanding structural heart portfolio. We continue to expect 2026 R&D as a percentage of sales to be approximately 17%. Fourth-quarter adjusted operating profit margin of 23.7% was aligned with our previous guidance of 20%. Our full-year 2025 adjusted operating profit margin of 27% was within our original expectations for the year. For 2026, we expect approximately 150 basis points constant currency operating margin expansion which includes less spending related to removing GennaValve from our operating plans for the year. We continue to plan for 50 to 100 basis points of operating margin expansion annually on average in 2027 and beyond. We continue to plan to deliver leveraged earnings per share. Turning to taxes. Our reported tax rate this quarter was 29%, or 17.9% excluding the impact of special items, which was above our expectation for the quarter driven by Pillar two impact and country income mix. We continue to expect our 2026 tax rate excluding special items, to be between 16% and 19%. Turning to the balance sheet, We continue to maintain a strong and flexible balance sheet with approximately $3 billion in cash and cash equivalents as of December 31. Edwards Lifesciences Corporation currently has approximately $2 billion remaining under its share repurchase authorization. Average diluted shares outstanding during the quarter were 582 million. We continue to expect average diluted shares outstanding for 2026 to be between 580 to 585 million. Foreign exchange rates increased fourth-quarter reported sales growth by 170 basis points or $20 million compared to the prior year. FX rates had minimal impact on our fourth-quarter gross profit margin compared to the prior year. Relative to our October guidance, FX rates had a nominal impact on fourth-quarter earnings per share. At current rates, we now expect FX to have an approximately $40 million upside to full-year 2026 sales compared to the prior year. I will finish with comments related to our outlook. We have increased confidence in meeting our 2026 full-year sales growth rate guidance of 8% to 10%, and earnings per share guidance of $2.90 to $3.05. The product group sales guidance we provided at the investor conference remains unchanged. For the first quarter, we are projecting sales of $1.55 billion to $1.63 billion. We expect slightly higher growth rates in 2026 following unusual summer seasonality that benefited 2025. We are expecting adjusted EPS in Q1 of $0.70 to $0.76 representing mid-teens growth at the midpoint of that range. With that, I will pass it back to Bernard.

Thank you, Scott. In closing, we finished 2025 strong. And achieved many lasting catalysts, We have increased confidence in our top-line and bottom-line guidance for 2026. Our strategy of focusing on structural heart is demonstrating impactful results for the company, and the patients we serve. And is positioning us for long-term sustainable growth and value creation. With that, I will turn it back over to Jerrianne. Thank you, Bernard.

We're ready to take your questions. As a reminder, please limit the number of questions to one plus one follow-up to allow for broad participation. If you have additional questions, please re-enter the queue and management will answer as many participants as possible during the remainder of the call.

Thank you. You may press 2 if you would like to remove your question from the queue. Before pressing the star keys. Our first question comes from Robbie Marcus with JPMorgan. Please state your question.

Great. Congrats on a good quarter. Thanks for taking the questions. Two for me. First, maybe just on TAVR 10.6%, another very strong quarter. I would have to imagine you're taking some share even excluding the Boston Scientific exit. So maybe just speak to the strength you're seeing, the confidence in it, and any regional differences. And just one thing, if you can talk to volumes versus sales, I imagine the Delta's price. But had some questions on that.

Thanks. You know, Robbie, good afternoon, everyone. Yes. You know, one is, you know, we are very pleased about the quarter overall in the year for Edwards Lifesciences Corporation. With regards to TAVR, very pleased about the quarter. Like you said, you know, growing 10.6% year over year. And what we see is really the result of our strategy here, where last year, we brought, you know, very compelling evidence. Early TAVR, Partner 3 seven years, Partner 2 ten years, And all of this gave confidence. All of this also enabled a renewed focus on, you know, TAVR as a category and specifically, you know, the SAPIEN platform. So this is creating, you know, physicians to talk more about TAVR, talk more about SAPIEN, You know, this is enabling physicians to treat, you know, their patients a little bit, you know, early. This is also, you know, enabling providers to prioritize TAVR. So it is all of that together I'm going to ask you, Daniel, you know, to give you some more, you know, specific details about the quarter.

Yeah. Thanks, Bernard. And, Robbie, you're spot on. Right? Like, the overall procedural growth rate in the quarter was in the high single digit. And so there is a gap, and you're absolutely on the money as far as share gain and pricing contributing to that gap. Largely on the share perspective, I mean, the share gain that we had from the Boston Scientific exit contributed a big chunk of that. We are pleased to see the stickiness of that share gain from quarter three to quarter four. We took our piece of that, but most of the competitors in Europe also benefited from Boston's exit. I would say that we benefited about in line with our competitive position in the market. But if you look at globally, like, overall, our competitive position remains relatively stable, I would say. I mean, you know, for sure, we're not weaker, in Q4 than we were in Q3. Another piece of this is S3 UR penetration. Right? And we continue to see very strong adoption of this outstanding platform. A lot of positive feedback from physicians. And so this is also contributing, like you mentioned, a little bit on the price side.

Great. Maybe, Scott, just if you could talk to the increased spend on market access you highlighted. In the fourth quarter, the step up in SG&A was roughly $100 million which is pretty substantial. So maybe just dig into that, where'd the spending go, and how should we think about that? We rolling in is we think of that as a one-time cost? Thanks.

Yeah. Thanks, Robbie. I appreciate the question. We had planned a step up in the fourth quarter spending, and we decided to be aggressive in light of the reception we were getting to the things Bernard mentioned earlier. The asymptomatic trial that seven-year results, the ten-year results. And so we intentionally upped the spending in the fourth quarter. A $112 million year over year. We were still in operating margin terms in the area that we had expected for the fourth quarter. So we had said mid 20% and that was sort of in the range of where we came in. We invested more aggressively in patient access. So asymptomatic amplification, Bernard mentioned the American Heart Association partnership. We've also been reinforcing our field force in THV and also in TMTT. Some of the spending was delayed from earlier quarters in 2025. So we are, you know, following this elevated level of spending in Q4, planning a more moderated operating expense growth and SG&A expense growth in 2026. Which is how we get to the operating margin guidance of the high end of our original 28% to 29%. The other benefit in that margin increase or margin expansion is the exclusion of the original spending that we had planned for GennaValve. Maybe, Daniel, you wanna talk a little bit more about some of these initiatives?

Yeah. I think, like, a couple of big ones here. Right? So with the change in the European guidelines, this is the biggest shift that we've seen in over ten years, and it's a real important shift from watchful waiting to intentional and urgent treatment of severe aortic stenosis earlier in the disease pathway. This is a big shift. It involves change management. And change of behavior, particularly at the referral level. And so we see an opportunity here to bend the curve of adoption of these guideline changes. And so we have a number of significant amplification programs that we have started and started to implement in Europe. This is a big one. Second one, as Scott and Bernard mentioned, our partnership with the American Heart Association. This is an important one, and this is a multiyear partnership. And it's designed to do the same thing, democratize and educate on the importance of treating earlier in the disease pathway for aortic stenosis. And so this is all designed to improve diagnosis and treatment of severe AS, through guideline-based care, through extended data collection, but also heavy on education. And so these are two big ones. We also invested further in some of the sort of short-range pilot stage marketing programs to improve treatment rates and patient and referral education in The United States. And like Scott said, there are some field relay you know, we're very much a high-touch field clinical field force, and with volumes increasing, we need to get ahead of those resources in the field. They take time. They take time to train and get people certified. So we got ahead a little bit of that, but also a big chunk we got behind early in the year, and a lot of that caught up with us in Q4. So they're the big items.

Thank you. And your next question comes from Travis Steed with Bank of America. Please go ahead.

Congrats. Just wanted to maybe focus on for TAVR and total company growth, anything to kind of call it for cadence over the year? And wasn't clear on an organic basis what Q1 was to me since I didn't have the FX impact in Q1. And then any comments on kind of like the January trends you've seen so far to give you confidence in the guide? Then I had a follow-up.

Thanks, Travis. Yeah. So I mentioned that we expect about $40 million of tailwind from FX to sales. This is changed since our investor conference. A lot of that falls in the first quarter. And so we're expecting Q1 sales growth on a reported basis to be about 300 basis points higher than the underlying growth that we are expecting in Q1. Now remember, the first half growth rates in Q1 in 2026 should be higher than the second half growth rates. And maybe Daniel will ask you to talk a little bit more about that.

Yeah. Thanks, Scott. And hi, Travis. Yeah. It's true. The growth rate in our guidance moves down a little bit over the course of this year. As previously, we guided that the front half will be stronger than the back half in '26, and this is because we have much tougher, much higher year-over-year comps in the second half. We also applied classical seasonality and other assumptions to the year. That weren't the case in 2025, that makes it a little bit more of a challenge. But the Q4 results that we had in 2025 give us increased confidence in our 6% to 8% guidance. And this is really important. On top of that, we have these meaningful tailwinds and catalysts later in the year. That give us confidence in the mid to high single digit beyond 2026.

Got it. Then I have a follow-up on the TAVR NCD. You called it a potential tailwind later this year. Just wanted to kind of think about how you're seeing that help growth more centers, faster patient pathways and if you read the public comments, it's they're all mostly positive on expanding the indication, but there's a bit more debate on the care team. So curious if you think how that shapes up in the final and how it might impact the different scenarios you're thinking about.

Yeah. So I'll take this one. I think obviously, it's very, very important. The first phase first of all, it's important that the process was formally reopened. That was really important. That happened right before the end of the year. And the first phase is now over, as Bernard mentioned. So we expect the initial draft around the June time frame. There'll be a second round of public commentary at that point. And then assuming that the normal CMS process, follows the final determination could be in the Q4 time frame. So if you think about impact for 2026, negligible, but probably important and more relevant in 2027 and beyond. Now the key priority areas for us is to ensure timely and equitable access care for patients. Right? And the big win for patients would be coverage to label, and any changes that may reduce procedural complexity or help improve equitable access to care. So that's what we're focused on. But, you know, we need to see what the draft looks like, and we look forward to the process continuing. And like you mentioned, we're also pleased that most of the commentary was positive and largely in line with our thinking.

Thank you. Your next question comes from Larry Biegelsen with Wells Fargo.

Two for me. I wanted to just ask about the LAA opportunity. How big is that market today a competitor that has a device with sales of I think, over $200 million. How is yours differentiated, and how do you want us to think about you know, your LAA sales ramp over the next few years? And I had a follow-up.

You know, we apply, you know, always, you know, the same filter. When we decide to get into a new space, it is all about, you know, is there a big unmet patient needs? Can we have an impact? Can we bring differentiated technologies? And so we look at this one, we say yes, yes, and yes. So how big it is? We don't know where, you know, very well, you know, this segment yet. But we believe there is some technology out there. We believe there is still unmet patient needs. And long term, believe we can have an impact here. But I'm going to ask you, Daveen, which is very close to this one, to add some comments.

No. Thanks, Bernard. Thanks, Larry, for the question. Yeah. Obviously, as we mentioned, we're looking to enter the market later this year. And if you look at existing technologies out there, we think there's still unmet patient needs. And that's where we believe, obviously, that we can come out with the technology in this new therapeutic area for Edwards Surgical we can come out with a solution that can really help patient care. And we see this as a complementary solution to our specific valvular procedures that we're already in. So as a result of that, we kind of see kind of, you know, a measured commercial rollout an opportunity to be a growth driver in the future, for Edwards Surgical.

That's super helpful. Bernard, you know, we saw the long list of catalysts, in '26 in your press release today. And I think people will notice that you didn't mention moderate AS. So can you talk about why you left that out and how you're thinking about the moderate opportunity today? Thanks for taking the questions.

Thanks, Larry. I'm glad you saw you have a long list, and indeed, it is a very long list. And let me first, you know, talk a little bit about, you know, why all of these catalysts? And then we get to your question about moderate. The list is very, very long because of our very unique strategy. Where we invest early. We are very committed. We have a flawless execution. I'm sure you have seen that. The kind of result we have had in 2025 is pretty spectacular. Financially, having all these catalysts, you know, new technologies, you know, new evidence, you know, lasting evidence. You know, lasting impact. All of them are, you know, basically, in play, you for this year. With moderate, for sure, you know, moderate is a big category. You know, we know that, you know, the moderate prevalence is bigger than the severe one. We know it is big, but at the same time, we don't know what the study result will be. So we are waiting, you know, to do more about, you know, progress, you know, the progress trial, which will be presented at TCT to talk more about it. What you'll believe what you have seen is but where we know for sure when it is coming and the type of impact, you know, we are going to have. Progress and moderate big opportunity. We don't know yet. You'll have a study of results. Thank you.

Your next question comes from David Roman with Goldman Sachs.

Thank you. Good afternoon, everybody. I was hoping you could go into a little bit more detail on the comments regarding lifetime management for TAVR and maybe more specifically talk about what you think the implications will be to valve and vendor selection balloon expandable versus self-expandable? And how that might end up being a contributor to incremental market share gains as you think about the TAVR business here in 2026 and beyond?

I know that, you know, Daniel has a lot of passion about this one. So I'm going to let Daniel, you know, talk about this.

No. You're on the right point, David. I mean, look. The evidence and when I say evidence, I'm talking the early TAVR evidence, the subanalyses from early TAVR, the evidence that, the likes of Philippe Genreau has published now on acute valve syndrome. And then you've got Partner 3 and Partner 2 long-term data on top of this all pointing to the fact that you know, you're gonna get a better clinical and economic benefit if you treat earlier in the disease pathway. This is a huge shift and it changes the conversation between doctor and patient. So if you can imagine a year ago or a little bit more, you might have it might have been something along the lines of, let's see if we can eat this out another six months or twelve months or maybe a patient would want to thinking that they're trying to time their treatment and trying to figure out how to make their valve last as long as possible to avoid secondary or tertiary procedures. And this conversation has completely shifted because the evidence says that you know, the benefit of doing that is not there's no upside to that. Right? There's no upside to waiting anymore. And so this brings in to the very important conversation and concept of lifetime management. This is very, very important because you gotta get the first procedure right to make sure you've got options and the right options for patients for their second procedure, whether that be another valve and valve or whether that be coronary artery access you know, PCI or what have you. And so you know, we think our platform is uniquely positioned both acutely and with lifetime management options, whether that be secondary or tertiary procedures. And I think that's gonna be one of the key value propositions that we have not only immediately, but in the years to come.

And maybe just a clarification there. So in that scenario, is it reasonable to expect that just a significant percentage of patients receiving TAVR either in the asymptomatic or call it the sub-seventy-five population, that creates a unique opportunity for SAPIEN? And maybe just my follow-up, I'd ask you on capital allocation. You've obviously pulled the GennaValve deal did not end up coming to fruition. You bought back a good amount of stock last year, but you've also made some key hires to the business development team. Maybe just talk to us about your latest thinking here on capital allocation.

Yeah. So as far as the look. Whether it be younger patients or whether it be elderly patients, there's a good chance now with modern medicine and the way that this is going that patients will outlive their first valve. I mean, it's, I think lifetime management considerations is not just now for youthful patients. And in fact, more and more, we see we find ourselves in scenarios where certain valve platforms were chosen with the idea that the patient would not outlive that valve and then you know, finding the options for that patient limited at that time point, which is really disappointing. So this lifetime management thing getting the first procedure right, upfront is a big thing. It is a conversation that everybody is focused on in the clinical community. Now as far as strategic allocation, look. We think valve and valve and whether you throw in leaflet modification or other types of things associated secondary procedures, We think this is going to be very real. It's small now, but it will be growing. It's all about the denominator, right, and the numerator. And so you know, we're looking at ways as we always do to lead in this space and that's something that we're looking at very, very closely. The other thing that obviously we do is we look at how we apply our field force here and how we invest in our field force and what kind of value that we bring with our service model as these conversations and these types of procedures evolve, in terms of how to get the best outcome for a patient at any given time.

And on capital allocation, David, our priorities have not changed. Our first priority is investing in the business to support our growth. And that comes in the form of making sure we've got sufficient production capacity and we mentioned at the investor conference, we're increasing our production capacity to keep up with the growth in TAVR and TMTT and surgical. It also involves making external investments. And so we've got a number of different activities underway. We've always been active in M&A. As you know, most of the things that we invest in or purchase tend to be smaller in size because we're focused on structural heart. But that's gonna be a continual direction for allocation of capital. And then share repurchase is one of our best ways to return capital to shareholders. And we continued our share repurchase activities in the fourth quarter. We bought back about $40 million bringing the total repurchase in 2025 to just under $900 million. We still have about $2 billion of authorization remaining, and you should expect that we're gonna continue to look for opportunistic times to repurchase more shares.

Thank you. And your next question comes from Joanne Wuensch with Citibank. Please state your question.

Good afternoon and thank you so much. Could you give us a little bit of a state of the union on how M is being taken up in The United States and any or what impacts are going outside The United States? And then if you could just sort of flesh out and give a little bit more color on the guideline changes that are happening in Europe? How to think about those impacts for the remainder of the year. Thank you.

Hey. Thanks, Joanne. It's Daveen. I appreciate the question. Talking a little bit about the SAPIEN M3 Launch, We're Just Starting In The U.S. Right? We got approval, obviously, right before the end of the year. And it's kind of scaling in line with our expectations here in The U.S. And we're just starting to open up centers, really focusing on centers who are in our ENCIRCLE pivotal clinical study first. In Europe, we're scaling in line with expectations as well. But it's still pretty early in the process. I think what we like that we're seeing is that we're getting really high procedural success and we're getting really great patient outcomes. Remember, I was with a patient just the other week, who had previously had mitral valve surgery and then needed an M3 because his surgery had failed. And for him, hearing about the difference his life made when he had no other tear or surgical alternatives with mitral regurgitation really hurting his life, and how he just got so much better. Just it warmed my heart so much to kind of hear that. So because of that, we're seeing this physician excitement, because there's a group of patients who didn't who don't really have tear or have great surgical options. For which M3 really becomes a good opportunity. So for us, we're continuing to appropriately kind of scale up, open up new centers, and bring this therapy to new patients. So that's kind of SAPIEN M3. And maybe moving on to kind of European guidelines, you start with TAVR guidelines? Or the European guidelines. So I can talk about the FMR guidelines a little bit. So yeah, so on the and the European guidelines with FMR, they're now class one for functional mitral regurgitation for reduction of heart failure hospitalizations. So we're seeing, I think, increased awareness specifically in mitral and tricuspid, increased awareness for these two diseases. And increased kind of referrals happening with these guideline shifts. So we see it as a helping continue that double-digit tier market growth that we've been seeing. And maybe passing on to TAVR for a comment on the guidelines, Daniel.

Joanne, as you may recall, the guidelines on the TAVR side changed in a meaningful way on two fronts. One is they reduced the age recommendation TAVR. Going from 75 to 70. Right? That's one big element of the change. And then the other element was you know, this whole concept of recommending corrective disease management regardless of symptom or heart function. So this is you know, basically taking you know, changing the dogma of watchful waiting in Europe, and so this is a huge shift. Now that is a that requires a lot of education. You can imagine, We're seeing definitely, we did see healthy procedural growth in Q4 in Europe. And some of the large countries, contributed that in a meaningful way. But the way that we look at this is the guidelines won't be a light switch whether it be in Europe or The U.S. or Japan. But give us an opportunity as those get disseminated, as those get democratized, and then, put into practice. It's just layers and layers of durable growth, for us. And so that's kind of how it's playing out. Not a light switch, but definitely momentum.

Thank you. Your next question comes from Matt Taylor with Jefferies. Please state your question.

I wanted to dig into the better performance we've seen in TAVR especially in The U.S. the last couple of quarters and just ask you what you thought was causing that. You're not benefiting from Boston there, really. Are you gaining share? Can you estimate how much early TAVR has been contributing? Or are there other factors? What's really caused the increase in growth in The U.S. in the last couple quarters?

So, yeah, thanks for the question. And I think, you know, without trying to be on repeat here, but this data, this very, very compelling data, not just on the early TAVR and the asymptomatic side, and not just clinical, but also economical economic data. I mean, I can't stress how important the economic data benefit of economic of the economics, treatment of patients and the hospital economics earlier in the disease pathway is having an effect as much as the clinical data. So these two things tied with definitive durability data is creating a wave of confidence in the community to have a different conversation. It is also forcing, if you like, the aortic stenosis patient, the TAVR patient, to be prioritized differently and to be treated with urgency. Alright? Typically, you might see a little bit more rearranging of the patient list to bring more sick patients to the front of the list, and the more healthier patients towards the back of the list. Rather than just getting through the list. And this conversation is completely different now. And people are focusing on this intentional and urgent treatment of symptomatic AS. So this is regardless of whether the patient is asymptomatic or not. This is the impact that it's having on symptomatic aortic stenosis is what we see largely driving our growth. When we look at the claims data, we don't see asymptomatic patients coming in in waves through the claims data, and that shouldn't be a surprise because the NCD doesn't cover asymptomatic indications at the moment. So you know, right now, that's not a huge surprise. What we do see, though, since the indication in The United States, we do see an increase in the number of echos. We do see an increase in the number of referrers. Referrals. We do see a decrease in time from referral to CT, which the heart team evaluation. And interestingly enough, we do see a relatively sharp increase in stress tests. For patients and nobody typically likes to do stress tests. And so that's also an interesting finding that we see in the data. And so, definitively, this is all positive momentum. And it's driving a lot of growth. But as I mentioned before, the other thing that is supporting and contributing to the performance in Q3 and Q4 is the success of SAPIEN 3 Ultra Resilia. That's making a meaningful contribution, you know, to our performance. And we're pretty happy with that.

And big picture here, if you process, you know, all of this that Daniel, you know, talk about, This is what gives us confidence. In our guidance for the year for 6% to 8%. And our guidance beyond 2026 for TAVR from mid to high single digit. You know, all what we are doing right now, you know, all of the things we have been doing, all of these catalysts are impacting you know, severe symptomatic patients. And so, you know, the asymptomatic patient still in front of us, and it is why we are so confident as to have either a or a durable growth opportunity for Edwards Lifesciences Corporation. Thank you. Thank you. Thank you.

Your next question comes from Vijay Kumar with Evercore ISI. Please state your question.

Hey, guys. Thanks for taking my question. My first one was quick housekeeping. Scott, I think you called out Sabre was impacted by some distributor adjustments. Could you quantify what that is? And is the Q1 guideline a 10% TAVR growth?

Sorry. Vijay, could you say that the first part of your question one more time, please?

Sorry. On Sabre, you called out a distributor impact in Q4. Could you quantify what the impact is? Are those sales coming back in Q1? And just curious on what gets us to Q1 sales guidance? Is it Sabre are we modeling TAVR of 10% growth?

Yeah. Sure. Thanks for the question. Yeah. The surgical inventory adjustment was in one country. It was end of the year, and it was really adjusting inventories in the distribution channel. You know, in China, we go through distributors and we work very carefully on managing inventory levels. And so this is just something that we did at the end of the year. We still expect mid-single-digit growth from surgical. In 2026 and beyond. So think of this as a one-time event.

No. Sorry. Q1.

Yes. So Q1, the guidance implies, I mentioned before, on a reported basis, about 300 basis points higher than the underlying growth guidance. We haven't broken out specific underlying growth guidance, but know that the growth in the first half of the year is higher than the growth in the second half of the year. And overall, we're increasingly confident about the 6% to 8% full-year growth guidance for TAVR.

That's helpful. And then maybe one on the Moderate AS. What is, I guess, a great way to think about moderate AS? You know, when these patients are untreated, right, do they look like, low-risk TAVR patients? Is this asymptomatic, you know, TAVR? What's the right way to think about Moderate AS, and what's the underlying mortality rate in untreated moderate AS patients?

Maybe, you know, let me start with Vijay and first, you know, when we decide to start a big pivotal study, randomized study, multiyear randomized studies like this one, It is because we believe you know, we can show the benefit to patients. It is because we believe it is a big opportunity. It was because we believe in that case, you know, SAPIEN 3 will have a big positive impact on these patients. So that's just to make sure that you feel our confidence and our belief you know, behind you know, progress in the moderate AS patient population. Having said that, we know the importance of highly scientific clinical studies and as a company relying a lot on world-class evidence you know, we are trying not to talk a lot about, you know, before having seen the results. We know the importance of it. But it is why, you know, some studies are more, you know, like, you know, market studies, you know, marketing studies. So people, you know, have a freedom to talk about it. And here, you know, we want to have a very high bar in terms of clinical evidence. So we have confidence belief, it's the large patient population, and we are going to wait, you know, TCT to share more about it. Now Daniel, do you have anything that you want to share in addition to what I said here?

Yeah. The only additional color that I would say is we learned a ton from our asymptomatic early TAVR trial about how unpredictable the nature of the disease is. And you know, this whole idea of that it's a progressive predictable disease is being thrown out the window even on early TAVR. And you know, this is not an asymptomatic trial. Right? PROGRESS is not asymptomatic. Moderate. Right? So we're talking about a symptomatic patient population and we don't know the results of the trial. We don't know, what it looks like. What we do know is it enrolled very fast. Right? And that's usually a bit of an indicator, of things. And so you know, we're excited to sort of just learn more about how this can inform you know, this patient population and how, you know, transcatheter therapies may fit into this. But until we see the data, until we get past TCT, there's not a lot more to add.

Thank you. And ladies and gentlemen, we have reached the end of the question and answer session. So I will now hand the floor back over to Bernard

Yes. Thank you so much. Thanks for your continued interest in Edwards Lifesciences Corporation. Scott, Jerrianne, and myself. Welcome any additional questions by telephone. Thank you so much, and have a great rest of your day.