Edwards Lifesciences Corporation

Greetings and welcome to the Edwards Life Sciences first quarter 2025 results. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If you require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce you to your host, Mark Wilterding, Senior Vice President of Global Finance. Thank you, Mark. You may begin.

Thanks, Alicia. And thank you, everyone, for joining us this afternoon. With me on today's call is our CEO, Bernard Zavigian, and our CFO, Scott Ullam. Also joining us for the Q&A portion of the call will be Larry Wood, our Global Head, Global Group President of TAVR, and Surgical, Davin Chopra, our Global Leader of TMTT, and Wayne Markowitz, our Global Leader of Surgical. Just after the close of regular trading, Edwards Life Sciences released first quarter 2025 financial results. During today's call, management will discuss those results included in the press release and accompanying financial schedules, and then use the remainder of time for Q&A. Please note that management will be making forward-looking statements that are based on estimates, assumptions, and projections. These statements speak only as of the date on which they were made, and Edwards does not undertake any obligation to update them after today. Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially. Information concerning factors that could cause these differences can be found in today's press release and Edwards' other SEC filings, all of which are available on the company's website at Edwards.com. Edwards' guidance reflects its current estimates of the impact from tariffs that are in effect or have been announced as of the time of this press release and assumes such tariffs remain in place for the remainder of 2025. Any modification to such tariffs or new tariffs could have a material impact on the company's future financial results and guidance. Unless otherwise noted, our commentary on sales growth refers to constant currency sales growth, which is defined in the quarterly results press release issued earlier today. Reconciliation between GAAP and non-GAAP numbers mentioned during this call are also included in today's press release. Quarterly and full-year growth rates refer to continuing operations and do not include discontinued operations. With that, I'd like to turn the call over to Bernard for his comments.

Thank you, Mark. Welcome, everyone. Here, please. Have confidence. Total company sales grew 8% to $1.41 billion in the first quarter, reflecting the benefits of our broad and differentiated portfolio of therapies to treat patients with structural heart disease. The many milestones achieving Q1 are the result of our focused strategy and our decades of unwavering dedication to driving breakthrough innovation in pioneering and leading categories. Collectively, these milestones mark the significant progress we have made to unlock this large and growing opportunity to transform care for millions of structural heart patients around the world. I'd like to thank our 16,000 global employees for their many contributions to advancing patient care. TAVR growth in the quarter was better than expected, as clinicians continue to adopt our -in-class SAPIEN technology. Looking ahead to the rest of the year, we continue to believe that the results of the early TAVR trial represent a multi-year growth opportunity that will begin with the expected application approval in the second quarter and expand with the evolution of policy and guideline changes in the U.S. and globally. And in late 2026, we look forward to the presentation of the results of a groundbreaking progress trial, which has the potential to further expand the therapy to many new patients with moderate AS. I am proud of our commitment to TAVR innovation and high-quality science that is increasing access to treatment options for all AS patients. We continue to be pleased with TMTT's strong momentum, reflecting our portfolio of differentiated repair and replacement technologies, and we are raising our 2025 TMTT self-guidance range to -$550 million. As a reminder, our successful TMTT strategy position us to become the first to develop and launch a transcantator tricuspid valve with EVOKE in 2024. Today, I am also very proud of the recent approval of our SAPIEN M3 in Europe, the world's first transcantator mitral valve replacement system, which will benefit many patients with mitral regitation who have limited treatment options. This breakthrough technology demonstrates our team's long-term and steadfast commitment to solving large, unmet patient needs. Edwards, with EVOKE, M4E, and Pascal, is uniquely positioned to meet the broad and diverse needs of patients with tricuspid and mitral valve diseases. In surgical, our category-leading business continues to benefit from increasing adoption of our premium Resilia portfolio in SPIRIS, MITREAS, and CONNECT. Edwards continues to invest in surgical innovation and evidence as we expand access to our therapies globally. Last week, at the Heart Valve Society meeting, 8-year data were presented demonstrating the excellent durability of a company's novel Resilia tissue, which is used in a wide range of Edwards surgical platforms as well as SAPIEN-free ultra-resilia. The results represent the longest follow-up study on the durability of valves, which highlights our dedication to pioneering unique innovation. With patients of all ages living longer and seeking higher quality of life, the importance of lifetime management has never been greater. We also continue to make steady progress advancing our portfolio of emerging opportunities, which we discussed at our investor conference in December. Our team continues to build capabilities to reach the millions of patients around the world who suffer from structural and heart failure. And in aortic regurgitation, we are enrolling patients in joining the pivotal trial for the Edwards J-Valve AR system. Turning to our 2025 financial outlook, we are confident in our full-year total company sales growth guidance of 8-10%. And we have plans in place to offset the estimated impact of a currently announced tariff and the estimated dilution from the J-Valve acquisition, which we are planning to close mid-year. As a result of our plans, we are in a position to deliver on our original EPS guidance of 2.40 to 2.50 cents. Our priorities continue to be serving the patients who count on us and maintaining the highest level of service and support to our physician partners around the world. Looking ahead to 2026 and beyond, Edwards is positioned to transform care for the many structural and heart patients it needs. We are confident that our strategic focus, unique innovation strategy, and exceptional work of our employees around the world will deliver significant value to patients, the healthcare ecosystem, and shareholders. Now I will provide some additional detail by product group for Q1. In Tavre, our first quarter global sales of $1.05 billion increased .4% over the prior year, or .5% when adjusted for billing days, which was a little higher than expected. Growth was comparable in the US and OUS. Edwards' strong competitive position and pricing remain stable globally with some regional variability. I am proud of our team's commitment to leading with science, supported by a decade of clinical research that set the standard for quality evidence and physician decision making. This significant body of high quality science from rigorous FDA trials underscores the excellent clinical outcomes delivered by Edwards' premium sapient technology. Last month, at the American College of Cardiology Conference, new clinical data from the early Tavre trials studying patients with asymptomatic severe AS were released. The data highlighted that delayed aortic valve replacement in this patient population was associated with worse outcomes. Additionally, a new study using cardiac biomarkers revealed that the rapid and unpredictable progression of the disease. Both studies underscore the need for urgent referrals for treatment evaluation for severe AS patients, regardless of symptoms. Also at ACC, new groundbreaking data from the DETECT-AS study were presented. DETECT-AS is the first randomized trial evaluating the impact of physician notification or echo alerts for their patients with severe AS that meet treatment guidelines. The study found that these echo alerts increase both treatment and survival rates for patients with severe AS. In the US, our leading sapient free ultraresilia platform continues to demonstrate strong performance. We are advancing initiatives to help hospitals treat structural health patients efficiently and manage increasing procedure volumes. We are encouraged by hospitals that have demonstrated the ability to scale to accommodate procedure growth. We are encouraged by discussions with key clinicians on the long-term impact of early Tavre data to streamline patient care. In addition, we expect asymptomatic indication approval in the second quarter. Outside of the US, we continue to focus on the value of our differentiated technology and increasing therapy adoption, especially in areas where Tavre remains underutilized and many patients go without care. In the first quarter, sales growth was supported by the continued expansion of sapient free ultraresilia in Europe. Sapient free ultraresilia continues to deliver exceptional clinical outcomes, reinforcing the differentiation of this -in-class platform. In Japan, we continue to face weaker procedure growth environment and competitive pressure. We remain dedicated to addressing the significant undertreatment of AS among the substantial and early population in Japan. In summary for Tavre, we are maintaining our full-year sales growth guidance of 5 to 7%. Long-term, we are enthusiastic about the durable mid- to -single-digit growth opportunity in Tavre, supported by the upcoming early Tavre indication approval, guideline and policy changes, and the potential to serve patients with moderate AS. Turning to TMTT, our unique and increasingly differentiated portfolio draws another quarter of an impressive growth, with a meaningful contribution to overall company performance. We are pleased with first quarter sales of $150 million, representing growth of about 60%, and led by increased adoption and balanced contribution from Pascal and Ivoque in the US, Europe and globally. We continue to see strong therapy adoption and expansion across both mitral and tricuspid. Globally, mitral tear procedures continue to grow double digits, and the developing tricuspid opportunity is growing even faster across both repair and replacement. Pascal continues to demonstrate its value for patient care. Its differentiated features are driving distinguished clinical outcomes, and adoption is increasing at both new and existing sites around the world. The Ivoque commercial launch is progressing well in the US and Europe, with continuing excellent patient outcomes. At the end of March, we were pleased to see the finalization of the NCD for Transkete Tertricuspid Valve Replacement for patients suffering from tricuspid disease. With the new NCD, Ivoque is now covered for all Medicare beneficiaries who meet the criteria outlined in the final coverage policy, expanding patient access to this important therapy. We are pleased with the recent approval of the Sapien M3 mitral valve replacement system in Europe. This revolutionary transketeterbide therapy is built on the proven Sapien platform, which has been used in more than 8,000 procedures in the mitral position. We continue to expect that results from the in-circle pivotal trial studying M3 will be presented at the TCT conference in October 2025. In addition, as part of our deep commitment to advancing science for patients with structural heart disease, a European post-market follow-up study is planned to continue evaluation of Sapien M3, following patients out to 5 years. As previously shared, we expect US approval of Sapien M3 to follow in 2026. The launch plan for Sapien M3 in Europe is focused on creating a new category, as we have done many times before, and achieving excellent patient outcomes. Without decades of experience, we are uniquely positioned to bring Sapien M3 to the many patients in need across Europe. We will work with all stakeholders to ensure patient access to this novel therapy, providing physician training, and working with policy makers to establish proper therapy coverage. Edwards is the only company that offers a transketeter portfolio that includes both replacement and repair treatment options for both the mitral and fricative valves, meeting the complex needs of underserved patients. We are committed to bringing this portfolio to patients in need around the world, and expect meaningful impact from these advanced therapies in 2026 and beyond. In our surgical product group, first quarter global sales of $251 million increased 3% over the prior year. We continue to see positive procedure growth globally for the many patients, best treated with Edwards premium Resilia portfolio, including Mitris, Inspiris, and Connect. We continue to generate high-quality evidence on our Resilia tissue technology. As shown in the 8-year data presented at the recent Heart Valve Society meeting, Resilia tissue valves had significantly improved freedom from structural valve deterioration and freedom from re-operation compared to non-Resilia valves. Also in the quarter, our surgical team made progress advancing important innovation around the world. Mitris launched in China with positive surge in feedback, and we anticipate receiving CE-mark approval for the Connect aortic valve conduit in Europe before year-end. And now, Scott will cover the details of the company's financial performance.

Great. Thanks a lot, Bernard. As Bernard mentioned, we are pleased with our first quarter total company sales performance and progress on our strategic milestones, which gives us confidence in our full year outlook. We are raising our original sales guidance range for TMTT to -$550 million, driven by more favorable foreign exchange and continued business momentum. Total company, TAVR, and surgical sales growth guidance ranges remain unchanged, but the company is increasing our original total company sales dollar guidance range by $100 million to account for recent movement in FX rates. Edwards now expects total company sales of $6.1 billion in 2025. So, now I'll cover additional details of our Q1 results, starting with earnings per share. We generated adjusted EPS of $0.64 in the quarter, with solid operating performance. Our gap EPS for the quarter was $0.62. A full reconciliation between our gap and non-gap measures, including adjusted EPS and other items, is included with today's release. Moving on to other elements of the P&L. For the first quarter, our adjusted gross profit margin was 78.7%, compared to .5% in the same period last year. We are maintaining our full year -79% gross margin guidance at this stage. However, we do expect some pressure from the weakening dollar, the impact of announced tariffs, and the expected close of the Genovalve acquisition. Selling general and administrative expenses in the quarter were $466 million, or 33% of sales, which was better than our expectation for the quarter, driven by lower sequential spending and deferral of certain strategic investments originally planned for Q1. Research and development expense of $255 million in the first quarter was equivalent to 18% of sales, a reduction from .6% of sales in the previous quarter. This lower ratio of spending reflects the company's prioritized investments in our structural heart portfolio in areas where we believe there are significant opportunities for breakthrough innovation and profitable growth. Adjusted operating profit margin in the first quarter of .1% was driven by better than expected sales and favorable mix, as well as some variable expenses delayed beyond Q1. We expect pressure on our operating margin as a result of the weakening dollar, the impact of announced tariffs, and the expected mid-year close of the Genovalve acquisition. However, we are implementing plans to mitigate these anticipated costs, and we maintain our full-year operating margin guidance of 27 to 28%, and our EPS guidance of $2.40 to $2.50. We continue to expect our 2025 tax rate, excluding special items, to be between 15 and 18%. Foreign exchange rates decreased first quarter reported sales growth by 170 basis points, or $22 million, compared to the prior year. FX rates positively impacted our first quarter gross profit margin by 40 basis points compared to the prior year. Relative to our February guidance, FX rates had a nominal impact on first quarter earnings per share. At current rates, we now estimate no impact from foreign exchange on reported sales in 2025 relative to 2024 versus our investor conference guidance of a $100 million reduction. As a reminder, our hedging strategy is designed to mitigate the impact of foreign currency fluctuations on the original EPS guidance we provided in December. 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 the end of the quarter. During the first quarter, the company entered into an ASR agreement and repurchased stock through a pre-established plan totaling $300 million. Edwards has approximately $1 billion remaining under our share repurchase authorization. Average diluted shares outstanding during the quarter were $588 million. We continue diluted shares outstanding for 2025 to be between $585 million to $595 million. So I'll finish with one final guidance comment. For the second quarter, we're projecting sales of $1.45 to $1.53 billion and adjusted earnings per share of $0.59 to $0.65. And with that, I'll pass it back to Bernard.

Thanks, Scott. Before I close this afternoon, I want to take a moment to acknowledge an important anniversary for the company. It was 25 years ago this month that we rang the bell at the New York Stock Exchange and officially began our journey as Edward Life Sciences. Since then, we have transformed care for millions of structural health patients around the world, solving large and complex patient needs and pioneering therapeutic categories. And our future is bright. Our foundation remains strong and we will continue to bring new innovation to the many structural health patients in need around the world. With that, turning back to Mark.

Thank you very much, Bernard. We are 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. Alicia, I'll turn it over to you.

Thank you. We'll now be conducting the question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tool will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your headset before pressing the star keys. One moment please while we pull for questions. Thank you. Our first question comes from the line of Larry Begelson with Wells Fargo. Please proceed.

Good afternoon. Thanks for taking the question. Congratulations. Good start to the year here. Scott, you can probably anticipate the first question. You're maintaining the EPS guidance despite the tariffs and the genivalve acquisition and maybe even currency. Obviously, people would love to hear you parse out how much each of those impact 2025 and how much lower could the gross margin be relative to the guidance. I had one follow-up.

Sure. Let's go through the three elements, Larry. Thanks for the question. On FX, our impact is from tariffs and the genivalve acquisition. For tariffs, it's probably about five cents to EPS based upon the tariffs that are already in place. Just a little color commentary on tariffs, we may not be as complex as some others because we operate just a handful of production facilities that are strategically located with our key business regions. We also already have a lot of production in the US. Think five cents associated with the 10% tariffs. Now, that's just for 2025. The tariff impact is higher than that, but as you know, they get capitalized into inventory and recognized in our P&L as finished goods are sold. The bigger impact is in 2026, but it's premature to be offering any guidance or speculation about what tariffs could look like when we get out there. For genivalve, we think the impact is probably in the range of five cents to 10 cents. Now, keep in mind we don't have current information. We haven't closed the deal yet, but based upon our estimates and the preliminary plans we have for integration, that's probably a good modeling assumption at this point.

That's very helpful. A follow-up for Daveen, Contract Husband. Congratulations on the NCD for Evoke. How do you see the NCD impacting the ramp of Evoke? Thanks for taking

the time to be here. Thanks, Larry. Thanks so much for the question. We can't be excited as Evoke has a new category for us. It's a great product. The NCD, as you know, was effective now in March of 2025. This is a transcatheter tricuspid valve replacement NCD. The NCD ensures that both the standard Medicare as well as the large Medicare Advantage patient groups have access to Evoke as outlined in the final coverage policy. This coverage policy was very much in line with our expectations, so it's kind of built into our guidance this year. We love the components of this NCD, including within an FDA approved indication under a heart team and in the context of the CED or coverage with evidence development to collect additional data on the therapy. So overall, it is in line with our expectations of 2025 being full steam with activating new sites and continuing to treat more patients with Evoke who are getting excellent outcomes. And this is the start of a great multi-year kind of growth opportunity for treating more patients. Thanks so much.

Thank you. Our next question comes from the line of David Rowan with Goldman Facts. Please proceed.

I wanted to start on the TAVR business. Maybe you could talk us through a little bit what you're seeing on the ground as it relates to either referral patterns or physician engagement post the presentation of early TAVR now that we're kind of six months-ish following TCT. And then maybe walk us through specifically what happens once you get the indication expansion approved and what the plan is to start to support market development effort and when we should see that show up in numbers. Then I have one follow-up.

Thanks, David. Yeah, that's a great question. Well, first of all, I think the data set was very, very strong that we presented at TCT, but it does take physicians a little bit of time to work their way through the data and really understand the important nuances. We followed up those, the TCT with a very strong deep dive at ACC, and there was a few things that came out of that. One was the unpredictable nature of these patients that have asymptomatic aortic stenosis. And I think one of the things that a lot of people have been utilizing and have been focused on is the use of biomarkers and the thought being that biomarkers would be predictive and would help physicians understand what asymptomatic patients they should refer and what patients they could safely wait on. And I think the surprising data that came out at ACC said that biomarkers were actually not predictive. They did not predict which patients had more serious events versus which patients just had a progression to more mild symptoms. So I think it just really stresses that these patients need to get referred. They need to get worked up by the HART team. And we've continued to work with the clinical community and our physicians to make sure we amplify that message. But of course, all we can do right now is just educate people on the publications on the data. We can't actually promote in any way, shape, or form treating patients who are truly asymptomatic because we don't have the indication yet. We do expect that to come before midyear, so we're on track for that. And the minute we get the indication approval, we have a detailed education plan. We can then begin reaching out to the referral base and doing all of the other things that we want to do to help amplify this message. But again, we expect the approval to happen in Q2.

Got it. Thanks for the detail there. And then on the TMTT side, as you kind of look 12 to 24 months forward, I believe you'll have tricuspid repair and replacement, mitral repair and replacement available US and OUS. So can you maybe help us just think about market segmentation a little bit in that category? How should we think about mix between repair and replacement today and going forward? And whether this category is more of a sort of, quote, toolbox approach for physicians or you think it converts to a one size fits all, be it in mitral or tricuspid?

Thanks, David. Let me start and then I will ask Devine to add some additional details. I want to start where we were a few years ago. We knew that tier technology and repair technology was not going to be sufficient to unlock the full potential of a mitral and tricuspid space. So it is why we went in with the toolbox. And we brought first Pascal, highly differentiated. And you have seen the kind of impact we are having to patients with Pascal. But we know that many patients cannot be treated with tier. So therefore, we were the first to launch Evoque, which is going very well. And we see we are treating more patients than just tier patients, tricuspid patients with Evoque. Here with M3, it is the beginning of a same journey here. It is going to take us multiple years to transition, expand. So to give you a sense about segmentation, right now it is a little bit early, but Devine is very close to that. So maybe I ask Devine to bring some color here.

Yeah. As Bernard said, it is hard to give exact segmentation. But I will try to give you at least some thoughts we have. Today in Europe now, as Bernard said, we have now repair and replacement for each mitral and tricuspid. So we believe with the two technologies together, we can treat a larger group of patients. Clearly in the mitral side, again in Europe, M3 has just gotten approved. And for M3, it will be over time to really build out this category to train physicians to get appropriate payment, et cetera, over time. And for that, we see we remember that the M3, that this is a product that is geared toward the tier and mitral surgery unsuitable patients. So it is for patients who do not have tier or surgery options. So over time, we still believe tier for coming years will be the largest part and then eventually over time, mitral will continue to grow, mitral replacement will continue to grow in its treatment of people offering that new option. In tricuspid in Europe, again it is a little different than the US where tricuspid tier has been around for many years and now the new category of evoke has been recently created in Europe where we are now adding more patients to the pool who are both tricuspid surgery and tricuspid tier ineligible. So now we are adding new patients who do not have an option in producing these amazing results. And so that is how we see the European market progressing in this couple of years. The US will have a little bit different dynamics, but you will still see that because tier has been very well established in the mitral space, we see mitral replacement as an additive therapy bringing patients off the sideline and offering a solution that they did not have before. In the tricuspid space, as you know, both repair and replacement entered the US market at similar times, so the clinical community right now is learning together about here which is the best repair patient and which is the best replacement patient. We have seen from experience in Europe so far that having a repair and a replacement solution is really important for treating the maximum number of patients. And but the exact ratio, we are going to figure that out together with clinicians in the coming years.

Great. Thanks so much.

Thank you. Our next question comes to the line of Travis Steed with Bank of America. Please proceed.

Hey, congrats on the quarter. First question I wanted to ask on TAVR capacity constraints and the potential for the TAVR NCD to loosen some of the requirements or potentially broaden some of the number of centers available to treat. And that's some of the ways that some of the capacity constraints can be eased over time.

Sure. Thanks for the question. Yeah, you know, we certainly feel it's the time to reopen the NCD. We think there's a number of things that need to be updated. You know, the first is the NCD needs to specifically cover asymptomatic patients just to ensure national coverage is standardized for all the patients that need that therapy. I think the second thing is we know that adding hospitals that could offer this therapy would improve care and give more people access. And I think that that's, you know, another important element. In terms of more broadly on capacity, I think some of the acute capacity issues that we dealt with last year, I think we're through the worst of that. We still see centers working actively to add capabilities. And, you know, we try to partner really closely with them. You know, we offer about clinic coordinator training courses. So if that's the constraint, you know, we can certainly help them train their staff. Some places, you know, it's more about anesthesia. And so we can, you know, bring in experts to help them adopt conscious sedation. You know, if they're just, you know, limited to, you know, two or three cases a day, we can bring in things like our benchmark program that can do more cases in the same time and the same footprint. So we continue to work with them. I think, you know, the reality is we have a lot of new technology. We have a lot of new indications coming. I think hospitals realize that. And I think they are investing. We've seen that. And they'll continue to do so. But the reality is they need to keep doing that because, you know, the indications, you know, right now it's going to be, you know, in the near term asymptomatic. But we know we already have a vogue. We know we have M3 coming. And then, you know, we're only, you know, a year and a half away from seeing the progress data, which could be another indication expansion. So I think the hospitals are more in tune with what the requirements are going to be on a go forward. So I think it's going to be all those things coming together. I think it's going to be policy. I think it's going to be guidelines. And I think it's going to be those investments that are going to be the long term solutions to capacity.

Great. That's helpful. And then I have a follow up on Q2 TAVR. I think the street's at 5.8%. I'm just curious if there's any call you want to provide on how to model Q2 TAVR and the remainder of the year in the second half and any days benefits to kind of call out over the course of the year for the remaining portion of the year?

Of course, we have .4% growth in the first quarter. And to get to the midpoint of our 5% to 7% growth rate guidance for the year, it tells you we need something in the 6% range for each of Q2, 3, and 4. Obviously, there's going to be some differences. We've got some changes coming during the course of the year, including asymptomatic indication. But probably the right place to model, Travis, is in the 6% range with some expected variability quarter to quarter.

Great. Thanks a lot.

Thank you. Our next question comes from the line of Robbie Marcus with JP Morgan. Please proceed.

Oh, great. Good quarter. Thanks for taking the questions. Two for me. Scott, maybe just on the EPS offsets, offsetting 10 to 15 cents for Edwards is a big move and really impressive. Maybe speak to sort of the undertaking you're doing to be able to offset that kind of headwind between tariffs and Yennavalve dilution.

Yeah, thanks for the question. You know, obviously, we've been anticipating the approval of Yennavalve and running a bunch of scenarios in the event that we're successful getting it closed, which we think we will. Our guidance for the year did not anticipate any impact from Yennavalve, but we've had plans to be able to take action when we got some confirmation and more confidence that we're going to get it closed. So we're ready to go. We do think that spending will step up a bit in the second quarter because it was lower than we originally had planned and expected in Q1. And that's really the reason why we ended up with 64 cents a share in EPS in the first quarter. You know, we're going to be looking at things like investments that we are planning to make that are more discretionary in 2025 that will not impact our sales guidance for this year. But at this point, we're not going to get into a lot more of the detail about where those items are. You know, I mentioned in the prepared remarks that we're really focusing hard on prioritizing our R&D investments and really focusing on things that can drive top-line organic growth and profitable growth and earnings over the long term. And we're going to keep doing that. And again, I think we can continue to execute our focus strategy while also doing what we need to do to offset those headwinds that we're facing now in 2025.

So just to add on that, Scott, well said. I would say we are very pleased about the way we are starting the year. Strong Q1, sales slightly better than expected, EPS, top end of the range. We have achieved so many milestones in Q1. You have seen all of them where we are going to be able to create a new category for us. Think about the multi-year growth opportunity ahead of us based on these new milestones. Then, you know, a full year outlook, confident, 8 to 10, raising of the TMTT guidance and being able to offset Yenaval's dilution and basically the tariff impact. We feel good about the year. We feel good about how we are running the company. Thank you.

Great. Maybe just a quick follow-up. The TMTT guidance range, part of its FX, part of its underlying, you know, first quarter was good but still pretty much in line with the street. How are you thinking about the split between FX and underlying and sort of the key drivers that are going to be the key drivers in the next year? I think we are going to be able to see some of the progress in the rate guide through the rest of the year. Thanks a lot.

Sure. I will just confirm on FX and then pass over to Vien to talk about just the operational performance and our outlook for the rest of the year. You know, for FX, think about this $100 million benefit that we are getting through the movement in FX rates and just spreading that across our businesses. Probably about half of the increase in $100 million would be spread across the other businesses. Of course, Tavro would be the biggest place for that to go. Devine, you want to talk about the other half of the guidance increase?

On the operational side of things, as you can imagine, we continue to see great momentum on both Pascal as well as Evoque. So both are kind of key drivers, both in Q1 and going forward as we just treat more and more patients. Maybe even I will give you just a geography component so it is good to look at that way as well. We see both coming from both the US and Europe. So, you know, in both these markets, Pascal continues to show its differentiation and Evoque as a new category continues to create, treat new patients that do not have great outcomes. So we see continued growth happening from that side as well.

Appreciate it. Thank you very much.

Thank you. Our next question comes from the line of Vijay Kumar with Evercore ISI. Please proceed.

Hi, guys. Thank you for taking my question. Scott, I had a couple of guidance clarifications, if you will. Maybe on the EPS guidance here, you called up the tariff headwinds in UNL. Are we expecting to offset, you know, that 10 to 15 cents of headwinds completely or should we be perhaps looking at the bottom half of the guidance range, just, you know, maybe block us through on what the offsets are?

Yeah. So it is a little premature to be more precise about where within that 240 to 250 we may fall. And the reason is because we have not closed Yenna valve yet. So part of this depends upon the timing of that close and when we start picking up some of that burn. And part of it depends upon what the integration plan looks like and what we are actually going to execute. That is why we gave a range and that is why we think the 240 to 250 range in EPS can accommodate different scenarios.

Understood. Maybe one on international. Japan was a little late. Maybe Cockwood trends within Japan.

Yeah. Thanks, Vijay, for the question. So for sure, our result in the quarter and even the last quarter was less than expected, a little bit disappointing for us. But we are very optimistic about Japan. What we have seen is a couple of things happening. Weaker procedure growth environment and we need to better understand that, what's happening there, and also some competitive pressure. So what we are doing is a couple of things. One is enhancing our capability in the region in Japan to accelerate market growth. One and better position our technology. You know that when our technology are very differentiated, when we bring our technology to patients, evidence demonstrates that they live longer, better quality of life, they avoid hospitalization, complication. So this is the kind of value we bring. We have a good story to tell. And I believe we are going to have all of the Japanese physicians responding very well to this. We are also enhancing capability in Japan to address the situation. So overall, long term in Japan, we see a big potential. Aging population, there is a lot of AS patients, mitral patients, glycosid patients. So clearly an opportunity for us, an opportunity to change patient care there.

Understood. Thank you.

Thank you. Our next question comes to the line of Matt Taylor with Jefferies. Please proceed.

Hi. Thanks for taking the question. I did want to follow up on TMTT. I heard your comments and I guess I just wanted to confirm that none of the guidance rates was really around M3. And also just wanted to think about how to maybe compare and contrast the launch of the mitral replacement versus what you've seen with Evoke and Tri-Custage. Should we expect it to be similar? Can you talk about when the European launch will start to contribute and what to expect from the US?

Yeah, sure. This is Davin. Matt, I can take that question. So first, the first part of your question, yes, you're correct that we had built in M3 into our original range for the year already. And the change in guidance did not have to do with the specific CE mark or the timing of the CE mark. We'd already kind of built it in. And as we look at this kind of therapy, we're beginning with a very controlled launch that's emphasis on this really high touch model that we have of supporting physicians and patients to ensure the highest quality outcome. The indication, though, of mitral replacement in Europe is different. It's more similar to Evoke in Europe and different than what we see Evoke in the US. Meaning, as I mentioned, mitral replacement is for patients who are unsuitable for mitral surgery or for care. So for that, yeah, we expect a gradual buildup. And in Europe, as you can imagine, we're drawing on our therapy and our experience in how to create categories because each country in Europe is very unique. There are different ways of getting incremental payment and coverage for our therapies. And we've got to work on that one at a time. And that takes time. Additionally, we've got to train physicians, train our own team and build it up. So we really see CPM3 in Europe being more of a gradual, long-term, important category of adding new patients with mitral disease to be treated. And yeah, hopefully that helps.

That's great. And then maybe you could just finish with the US, how that'll be different.

Yeah. So in the US, from different than Evoke in the US, as you can imagine, mitral replacement, again, the US will also have an indication unsuitable for care or mitral surgery. So again, these patients are already in the funnel. They may not be appropriate for surgery or tear. They don't have any other option. And now for many of those patients, M3 will be an option. Evoke, as you know, when we launched it, had a different broader indication for people for health status improvement for people with tricuspid disease. So there's not this layer of first, are you appropriate for tear or surgery? So with that, we would expect that the US mitral launch in general would be at a slightly slower rate probably than we think we saw with Evoke. But either way, we really see that the great news about this is that this technology replacement is really complementing tear and adding patients to allow us for that kind of multiple years of growth and as we add more patients with this new treatment.

Great. Thank you so much.

Thank you. Our next question comes from the line of Joanne Wansense with Citibank. Please proceed.

Good afternoon and thanks for taking the question. I just want to hit pause on the early TAVR label expansion and NCD because I think there's a couple of different things that are happening here. And correct me if I'm wrong. One is the label expansion. The second one is the NCD. The NCD could expand the number of centers. It could expand maybe something else. And I've also heard from some physicians, maybe, and expectations that it might eliminate the need for a cardiac surgery team in the OR. So could you just sort of like clarify what you think may happen? And then how long after all of that starts to layer on do you think procedures start to ramp? Thank you.

Yeah. Thanks, Joanne. I think there's a multitude of elements here. The first thing is the label expansion, which obviously is under FDA's control. And again, we expect that to happen in Q2. So that's kind of step one. The national coverage decision, that's under the purview of CMS. And they'll decide when they want to reopen that and when they want to reevaluate it. And given the safety of TAVR that's been demonstrated and the national registry that we have that really confirms the outstanding results across all of the centers that we've opened, we do expect there to be an expansion in the number of centers. How many will that be? That's going to be up to how they write the policy and how that plays out. And we'll see how they decide to streamline the team and try to make the healthcare system more efficient. The third big element is guidelines, which fall under the society purview. And how do they take this data? How do they update the guidelines so that patients with severe aortic stenosis but haven't yet pursued the symptoms, how do we make sure that they move through the healthcare system, they're properly screened and they're treated in accordance with what the data suggests? And I think we're still in that education process with a lot of folks. Sometimes people think that asymptomatic patients are automatically younger patients, but what we saw in the trial is I think the average age was 76, where for our low risk trial it was 73. So these aren't necessarily younger patients, we're not necessarily treating them at a much younger age. So I think these things are all important things that we just need to keep reiterating. And again, once we have the approval, it really takes the shackles off of being able to really advance our education platform and advance our ability to promote this. But until we get the FDA approval, we're just kind of at a standstill beyond what the physicians themselves, the investigators and people do at the big medical meetings.

Very helpful. Thank you.

Thank you. Our next question comes to the line of pitot chicory with Deutsche Bank. Please proceed.

Hey guys, following up on these NCD questions, our call is that the physicians, CMS is actually in final discussions with the societies and health systems about relaxing this entity to be certified to have a center and that this change could actually be coming in May or in June. Is this timing something that you guys have heard as well?

There's no predetermined timing. You know, it opens whenever CMS decides that they want to open it, and that is completely within their purview. And no one frankly has any influence over that. It's completely within their realm of control. So anybody that provides specific timing, they're simply speculating as to when they think that that could happen. So I don't have any insights beyond what I've already stated, and it's going to be up to them. Again, we do expect that a new policy, I think we have plenty of experience with the technology now. I do think the new policy will reflect the safety that we've demonstrated. And I do expect that at some point the policy is going to reopen. And I think one of the catalysts in front of CMS is going to be the asymptomatic approval. And one of the things we've seen historically, you know, when we first got approval for Sapien, it was under local coverage, and it did lead to some inconsistencies with how things were done. And that really drove CMS to open the NCD because they wanted to make sure that patients across all of their constituents could be treated under a national policy. So I expect that to happen again when exactly is going to be completely up to them. But when they do, then we get to engage with them. We get to start that process and hopefully end up with a policy that is going to allow more patients access to life-saving therapy.

Great. Then a follow-up here. Can you guys give us an update on how the demand for training for evoke is going and any color on how many sites have been trained or in a process to be trained? Thanks so much.

No, sure. This is Devin again. Yeah. So first, in terms of evoke sites, as you can imagine, we started originally with those first 50 or 60 clinical trial sites. And then from that, we've been continuing to invest in new sites that are, or work with sites that are investing in tricuspid disease. So that number is a growing number. We continuously are booking our trial sites out for several months in advance. So right now, if you're interested in a trial site, it's at least a couple of months away. And it's been consistently like that where the demand from physicians to get trained has been always a little bit greater than maybe our ability to open sites just on the ramp. And this really, as you know, has to do with the value proposition where people are seeing how the elimination of TR with evoke is really changing patients' lives. And as a result, both physicians and patients are asking for the technology. And so in general, though, as you can imagine, as Larry just mentioned, there are, what, 850 TAVR centers or so. I mean, it's a very big number. And our goal is some number of those would be great for tricuspid treatment, including evoke. And we continue each year just to keep opening and training new centers for many years to come, just like TAVR did over the course of many years.

Great. Thanks so much.

Thank you. Our next question comes from the line of Chris Pasquale with Nephron. Please proceed.

Thanks. The .6% surgical growth this quarter was the slowest we've seen from that business in a while. I know selling days had a bit of an impact, but can you just talk about your confidence in being able to sustain -single-digit growth in that segment, especially now that the resilient platforms have really become dominant in many of your big markets and you don't have as much of a tailwind from MIX?

Yeah, Chris, thanks for the question there. In Q1, we did have some challenging comps when we compared it to prior year when the business was growing in the high single-digit range. I think looking forward in 2025, as you heard from Bernard, we're launching Mitris in China. We've got some other potential tailwinds later on this year with the approval of Connect in Europe. We are remaining confident in our current guidance in the -single-digit range for 2025.

Great. That's helpful. I know this may be a bit difficult to answer given that the deal hasn't closed yet, but we saw some updated data from the Align AR trial at ACC. It continues to look solid. We're about 18 months out now from the original data presentation. Just any help you can give us in terms of what we should expect for a regulatory pathway and approval timing for that product.

Yeah, actually, we don't have anything that we can talk about on that. We're sort of pencils down until the deal closes, so we don't have any direct knowledge. We're not in conversation with them. Until the deal closes, we're sort of on the outside looking in. I don't have any more information than what you saw presented at ACC. All right, thanks.

Thank you. Our next question comes from the line of Patrick Wood with Morgan Stanley. Please proceed.

Beautiful. Thank you so much, guys. I guess maybe on Pascal doing pretty well, where are we at in terms of account breadth versus depth? I'm thinking is the utilization where you would like it to be? I'm trying to work out how wide you are versus how deep within individual accounts.

Yeah, sure. If you think about Pascal overall, we continue to see that this product has feature differentiation that we believe is leading to really predictable and positive outcomes for patients. You see that in accounts who currently have access to Pascal, that as they use Pascal more and more, they see those great patient outcomes and then they want to use it more. And then as you can imagine, they then tell their friends through different types of programs that Congress is so that sites who today who don't use Pascal are interested in trying to use it. And so that's how we see it spreading in both increased depth in certain centers as well as opening new centers. In terms of the number of centers, maybe specific, I'll just speak to the U.S. Again, I'll maybe I'll use the general calendar. If there are 850 TAVR centers, give or take in the U.S. or so, our goal is to grow into many of these that as many of these that make sense. But today we're definitely in less than fewer than 50% of them. So there's still a lot of opportunity for growth, both in new accounts as well as increasing penetration and seeing those great patient outcomes in the sites that currently use Pascal.

Thanks, Dean. That's helpful. And then very quickly, there's been a lot of sort of shuffle around with the FDA overall and people rehired that side of things. Is there any expectation from you guys that approval timelines long term could be affected or anything like that? Or is this just short term noise that we can ignore?

Yeah, obviously, you know, the situation is a fluid one and we are all watching. But so far, we don't see any change with the FDA approval timeline response to any submission, you know, that. So, you know, we feel like people at the FDA are very professional, they are very committed to the space and we don't see any impact and we don't believe we will see an impact. But obviously, it is a fluid situation that we need to monitor.

Awesome.

Thanks, Manab.

Thank you. At this time, this concludes the allotted question and answer session time. I would like to pass the call back over to management for any closing remarks.

Yes. So, you know, thank you, everyone, for your interest. So beyond the strong start of the year, you know, I'm very excited about what we were able to achieve in Q1 with this very strong catalyst. If you step back and you look at them, you know, we are on track to get an early tether indication approved in Q2. We had an NCD for EVOC, a CEPIOMM3 C mark, which, you know, basically represents the start of a new category for us. Resilia, eight years, amazing outcome. So all of that together give us confidence in what we told you in December at our Investor Conference. We believe we are very well positioned to transform care for the many structural health patients and we are continuing to target, you know, total company sales growth of 10% annually on average. So again, very pleased about the year, the numbers, all of the catalysts. I think all of our people, 16,000 employees, are doing amazing work and I want to thank them for that. Thank you for your interest in the company and if you need any questions, do not hesitate to call Sine, Mark, Scott or myself. Have a great rest of your day. Thank you.

That concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.