Edwards Lifesciences Q1 2025 Earnings Report

Edwards Lifesciences EPS Results

• Actual EPS: $0.64
• Consensus EPS: $0.60
• Beat/Miss: Beat by +$0.04
• One Year Ago EPS: $0.66

Edwards Lifesciences Revenue Results

• Actual Revenue: $1.41 billion
• Expected Revenue: $1.40 billion
• Beat/Miss: Beat by +$12.15 million
• YoY Revenue Growth: N/A

Edwards Lifesciences Announcement Details

• Quarter: Q1 2025
• Date: 4/23/2025
• Time: After Market Closes
• Conference Call Date: Wednesday, April 23, 2025
• Conference Call Time: 5:00PM ET

Edwards Lifesciences (NYSE:EW) provides products and technologies for structural heart disease and critical care monitoring in the United States, Europe, Japan, and internationally. It offers transcatheter heart valve replacement products for the minimally invasive replacement of aortic heart valves under the Edwards SAPIEN family of valves system; and transcatheter heart valve repair and replacement products to treat mitral and tricuspid valve diseases under the PASCAL PRECISION and Cardioband names. The company also provides surgical structural heart solutions, such as aortic surgical valve under the INSPIRIS name; INSPIRIS RESILLA aortic valve, which offers RESILIA tissue and VFit technology; KONECT RESILIA, a pre-assembled tissue valves conduit for complex combined procedures; and MITRIS RESILIA valve. In addition, it offers critical care solutions, including hemodynamic monitoring systems to measure a patient's heart function and fluid status in surgical and intensive care settings under the FloTrac, Acumen IQ sensors, ClearSight, Acumen IQ cuffs, and ForeSight names; HemoSphere, a monitoring platform that displays physiological information; and Acumen Hypotension Prediction Index software that alerts clinicians in advance of a patient developing dangerously low blood pressure. The company distributes its products through a direct sales force and independent distributors. Edwards Lifesciences Corporation was founded in 1958 and is headquartered in Irvine, California.

Edwards Lifesciences Q1 2025 Earnings Call Transcript

Presentation

[Operator]

Greetings, and welcome to the Edwards Lifesciences First Quarter twenty twenty five Results. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce you to your host, Mark Wilterding, Senior Vice President, Global Finance.

[Operator]

Thank you, Mark. You may begin.

[Mark Wilterding, SVP, IR and Treasurer at Edwards Lifesciences]

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 Ullum. Also joining us for the Q and A portion of the call will be Larry Wood, our Global Head Global Group President of TAVR and Surgical Devine Chopra, our Global Leader of TMTT and Wayne Markowitz, our Global Leader of Surgical. Just after the close of regular trading, Edwards Lifesciences released first quarter twenty twenty five financial results. During today's call, management Please note that management will be making forward looking statements that are based on estimates, assumptions and projections.

[Mark Wilterding, SVP, IR and Treasurer at Edwards Lifesciences]

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.

[Mark Wilterding, SVP, IR and Treasurer at Edwards Lifesciences]

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. Reconciliations 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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Thank you, Mark. Welcome, everyone, and Total company sales grew 8% to $1,041,000,000 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 achieved in 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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

TAVR growth in the quarter was better than expected as clinicians continue to adopt our best 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 indication approval in the second quarter and expand with the evolution of policy and guideline changes in The US and globally. And in late twenty twenty six, 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 TNT's strong momentum, reflecting our portfolio of differentiated repair and replacement technologies, and we are raising our 2025 TNT sales guidance range to $530,000,000 to $550,000,000 As a reminder, our successful TMTT strategy position us to become the first to develop and launch a transcatheter tricuspid valve with Evoke in 2024.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Today, I am also very proud of the recent approval of our SAPIEN M3 in Europe, the world's first transcatheter mitral valve replacement system, which will benefit many patients with mitral regurgitation 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 Evoque, 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, Mytris and CONNECT. Edouard continues to invest in surgical innovation and evidence as we expand access to our therapies globally.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Last week, at the Heart Valve Society meeting, eight 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 platform as well as SAPIEN three 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 continued to build capabilities to reach the millions of patients around the world who suffer from structural heart failure.

[Bernard Zovighian, CEO at Edwards Lifesciences]

And in aortic regurgitation, we are enrolling patients in JOURNIE, 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% to 10%, and we have plans in place to offset the estimated impact of a currently announced tariff and the estimated dilution from the Yanavalv 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 €2.4 to €2.5 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, Edouard is positioned to transform care for the many structural heart patients in need. 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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Now I will provide some additional detail by product group for Q1. In TAVR, our first quarter global sales of 1,050,000,000 increased 5.4% over the prior year or 6.5% when adjusted for billing days, which was a little higher than expected. Growth was comparable in The US and OUS. Eduard's strong competitive position and pricing remained stable globally with some regional variability. I am proud of our team's commitment to living with science, supported by a decade of clinical research that set the standard for quality evidence and physician decision making.

[Bernard Zovighian, CEO at Edwards Lifesciences]

This significant body of high quality science from rigorous FDA trials underscores the excellent clinical outcomes delivered by Edouard's premium Sapient technology. Last month, at the American College of Cardiology Conference, new clinical data from the early TAVR trial 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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 rate for patients with severe AS. In The US, our leading SAPIEN three Ultra Resilia platform continues to demonstrate strong performance. We are advancing initiatives to help hospitals treat structural heart patients efficiently and manage increasing procedure volumes. We are encouraged by hospitals that have demonstrated the ability to scale to accommodate procedure growth.

[Bernard Zovighian, CEO at Edwards Lifesciences]

We are encouraged by discussion with clinicians on the long term impact of early TAVR 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 TAVIAR remains underutilized and many patients go without care. In the first quarter, sales growth was supported by the continued expansion of SAPIEN three Ultra Resilia in Europe. SAPIEN 3 Ultra Resilia continues to deliver exceptional clinical outcomes, reinforcing the differentiation of this best in class platform.

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 elderly population in Japan. In summary for TAVR, we are maintaining our full year sales growth guidance of 5% to 7%. Long term, we are enthusiastic about the durable mid to high single digit growth opportunity in TAVR, supported by the upcoming early TAVR indication approval, guideline and policy changes, and the potential to serve patients with moderate AS. Turning to TMTT.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Our unique and increasingly differentiated portfolio drove another quarter of impressive growth, with a meaningful contribution to overall company performance. We are pleased with first quarter sales of $115,000,000 representing growth of about 60% and led by increased adoption and balanced contribution from PASCAL and EVOQUE in The US, Europe and globally. We continue to see strong therapy adoption and expansion across both Mitral and Tricuspid. Globally, Mitral tier 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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Its differentiated features are driving distinguished clinical outcome, and adoption is increasing at both new and existing sites around the world. The Evoque commercial launch is progressing well in The US and Europe, with continuing excellent patient outcome. At the March, we were pleased to see the finalization of the NCD for Transcutaneous tricuspid valve replacement for patients suffering from tricuspid disease. With the new NCD, Evoque 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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

This revolutionary transketchy device 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 five years. As previously shared, we expect U. S.

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 outcome. With our decades of experience, we are uniquely positioned to bring CPL-three 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 policymakers to establish proper therapy coverage. Edwards is the only company that offers a transcatheter portfolio that includes both replacement and repair treatment options for both the mitral and tricuspid valves, meeting the complex needs of underserved patients.

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 $251,000,000 increased 3% over the prior year. We continue to see positive procedure growth globally for the many patients best treated with Edouard's premium Resilia portfolio, including Mytris, Inspiris and Connect. We continue to generate high quality evidence on our Resiliat tissue technology. As shown in the eight year data presented at the recent Heart Valve Society meeting, Resiliat tissue valves had significantly improved freedom from structural valve deterioration and freedom from reoperation compared to non Resilia valves.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Also in the quarter, our surgical team made progress advancing important innovation around the world. Mytris launched in China with positive surgeon 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 detail of the company financial performance.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

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 $530,000,000 to $550,000,000 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 $100,000,000 to account for recent movement in FX rates.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

Edwards now expects total company sales of $5,700,000,000 to $6,100,000,000 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 GAAP EPS for the quarter was $0.62 A full reconciliation between our GAAP and non GAAP measures, including adjusted EPS and other items, is included with today's release. Moving on to other elements of the P and L.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

For the first quarter, our adjusted gross profit margin was 78.7% compared to 78.5% in the same period last year. We are maintaining our full year 78% to 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 GenaValve acquisition. Selling, general and administrative expenses in the quarter were $466,000,000 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 $255,000,000 in the first quarter was equivalent to 18 percent of sales, a reduction from 19.6% of sales in the previous quarter.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

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 twenty '9 point '1 percent 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 midyear close of the EniValve 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 $2.4 to $2.5 We continue to expect our 2025 tax rate, excluding special items, to be between 1518%. Foreign exchange rates decreased first quarter reported sales growth by 170 basis points or $22,000,000 compared to the prior year.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

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 $100,000,000 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.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

We continue to maintain a strong and flexible balance sheet with approximately $3,000,000,000 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 $300,000,000 Edwards has approximately $1,000,000,000 remaining under our share repurchase authorization. Average diluted shares outstanding during the quarter were $588,000,000. We continue to expect average diluted shares outstanding for 2025 to be between $585,000,000 to $595,000,000. So I'll finish with one final guidance comment.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

For the second quarter, we're projecting sales of $1,450,000,000 to $1,530,000,000 and adjusted earnings per share of $0.59 to $0.65 And with that, I'll pass it back to Bernard.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Thanks, Scott. Before I

[Bernard Zovighian, CEO at Edwards Lifesciences]

close this afternoon, I want to take a moment to acknowledge an important anniversary for our company. It was twenty five years ago this month that we rang the bell at the New York Stock Exchange and officially began our journey as Head of Life Sciences. Since then, we have transformed care for millions of structural heart 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 heart patients in need around the world. With that, turn it back

[Bernard Zovighian, CEO at Edwards Lifesciences]

to Marc.

[Mark Wilterding, SVP, IR and Treasurer at Edwards Lifesciences]

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 reenter the queue, and management will answer as many participants as possible during the remainder of the call.

[Mark Wilterding, SVP, IR and Treasurer at Edwards Lifesciences]

Alicia, I'll turn it over to you.

[Operator]

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 tone 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.

[Operator]

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. Our first question comes from the line of Larry Begleson with Wells Fargo. Please proceed.

[Lawrence Biegelsen, Senior Medical Device Equity Research Analyst at Wells Fargo]

Good afternoon. Thanks for taking the question. Congrats on a start to the year here. Scott, you can probably anticipate the first question. You're maintaining the EPS guidance despite the tariffs and and the GenaValve acquisition and and maybe even currency.

[Lawrence Biegelsen, Senior Medical Device Equity Research Analyst at Wells Fargo]

So 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? And I had one follow-up.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

Sure. So let's go through the three elements, Larry. Thanks for the question. On FX, our hedging program is designed to mute the impact of foreign exchange changes on our EPS. So the real impact is from tariffs and the UniValve acquisition.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

For tariffs, it's probably about 5¢ to EPS based upon the tariffs that are already in place. And, you know, 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. And, you know, we also already have a lot of production in The US. And so think 5¢ associated with the 10% tariffs.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

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 and l as finished goods are sold. So 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 Yenavalve, we think the impact is probably in the range of 5¢ to 10¢.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

Now keep in mind, we don't have current information. We haven't closed the deal yet. But based upon our estimate estimates and the preliminary plans we have for integration, that's probably a good modeling assumption at this point.

[Lawrence Biegelsen, Senior Medical Device Equity Research Analyst at Wells Fargo]

That's very helpful. And a follow-up for Davin on tricuspid. Congratulations on the NCD for Evoque. How do you see the NCD impacting the ramp of Evoque? Thanks for taking the questions.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

Thanks, Larry. Thanks so much for the question. Right? We we continue to excited as Evoque as a new category for us. Right?

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

It's a great product. And the NCD, as you know, was effective now in March of twenty twenty five, and 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, you know, within an FDA approved indication under a heart team and in the context of a CED or coverage with evidence development to collect additional data on the therapy.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

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 multiyear kind of growth opportunity for treating more patients.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Thanks so much.

[Operator]

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

[David Roman, Managing Director at Goldman Sachs]

Thank you. Good afternoon. I wanted just to start on the TAVR business. And 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?

[David Roman, Managing Director at Goldman Sachs]

Then I have one follow-up.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

Thanks, David. Yeah. That's a that's a great question. Well, first of all, I think the the dataset 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.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

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 the surprising data that came out at ACC said the biomarkers were actually not predictive. They did not predict which patients had more serious events versus which versus which patients just had a progression to more mild symptoms.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

So I think it just really stresses that these patients need to get referred. They need to get worked up by the heart team. And we've continued to work with the clinical community and and our physicians to make sure we amplify that message. But, of course, you know, 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.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

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, you know, a very detailed education plan. We can then begin re reaching out to the referral base and doing all of the other things that we wanna do to help amplify this message. And but, you know, again, we expect the approval to happen in q two.

[David Roman, Managing Director at Goldman Sachs]

Alright. Got it. Thanks for the detail there. And then on the TMTT side, as you kinda look twelve to twenty four months forward, I believe you'll have tricuspid repair and replacement, mitral repair and replacement available U. S.

[David Roman, Managing Director at Goldman Sachs]

And OUS. So could 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 toolbox approach for physicians or you think it converts to a one size fits all, be it in mitral or tricuspid?

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 track speed space. So it is why we went in with the toolbox.

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 TIR. So therefore, we launched we were the first to launch EVOQUE, which is going very well. And we see we are treating more patients than just TIR patient, TRYKASS patient with EVOQUE. Here with N3, you know, it's the beginning of the same journey here.

[Bernard Zovighian, CEO at Edwards Lifesciences]

It is going to take us multiple years to train physician, expand. So to give you a sense about segmentation, right now, it is a little bit early, but David is very close to that. So maybe I ask David to bring some color here.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

Yeah. As Bernard said, it's it's hard to give exact segmentation, but I'll try to give you at least some thoughts we have. Today in Europe now, as Bernard said, we have 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, M 3 has just gotten approved.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

And for m sapien m three, it'll be over time to really build out this category to train physicians, to get appropriate payment, etcetera, over time. And for that, we see we remember that the m three, that this is a product that's geared toward the tear and mitral surgery unsuitable patients. So it's for patients who don't have tear or surgery options. So over time, we still believe tear 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's a little different, sir, in The US than The US where tricuspid tear has been around for many years, and now the new category of Evoque has been recently created in Europe where we're now adding more patients to the pool who are both tricuspid surgery and tricuspid tier ineligible.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

So now we're adding new patients who don't have an option and producing these amazing results. And so that's how we see the European market progressing in next couple years. The US will have a little bit different dynamics, but you'll 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 didn't 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.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

We've 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 the exact ratio, we're gonna figure that out together with clinicians in the coming years.

[Operator]

Our

[Operator]

next question comes from the line of Travis Steed with Bank of America.

[Travis Steed, Managing Director - Equity Research at Bank of America]

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 if that's some of the ways that some of the capacity constraints could be eased over over time.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

Sure. Thanks for the question. Yeah. You know, we certainly feel if, you know, it's the time to reopen the NCD. We think there's a number of things that that need to be updated.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

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 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, you know, to add capabilities.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

And, you know, we try to partner really closely with them. You know, we offer valve 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 allow them to do more cases in the same time and in the same footprint.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

So we continue to work with them. I think, you know, send 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.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

But the reality is they need to keep doing that because, you know, the the indications, you know, right now, it's gonna be, you know, in the near term asymptomatic, but we know we already have Evoke. We know we have m three 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 gonna be on a go forward. So I think it's gonna be all those things coming together.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

I think it's gonna be policy. I think it's gonna be guidelines, and I think it's gonna be those investments that are gonna be the long term solutions to to capacity.

[Travis Steed, Managing Director - Equity Research at Bank of America]

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

[Travis Steed, Managing Director - Equity Research at Bank of America]

year?

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

That

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

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 q two, three, and '4. Obviously, the there's gonna be some differences. We've got some changes coming during the course of the year, including the asymptomatic indication. But probably the right place to model, Travis, is in that 6% range with some expected variability quarter to quarter.

[Travis Steed, Managing Director - Equity Research at Bank of America]

Great. Thanks a lot.

[Operator]

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

[Robert Marcus, Analyst at JPMorgan Chase]

Great. Good quarter. Thanks for taking the questions. Two for me. Scott, maybe just on the EPS offsets, offsetting $0.1 to $0.15 for Edwards is a big move and really impressive.

[Robert Marcus, Analyst at JPMorgan Chase]

Maybe speak to sort of the undertaking you're doing to be able to offset that kind of headwind between tariffs and Yenovalp dilution.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

Yes. Thanks for the question. Obviously, we've been anticipating the approval of Yenovalp 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 an impact from Yenavalve, but we've had plans to to be able to take action when we got some confirmation and more confidence that we're gonna get it closed. So we're we're ready to go.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

We do think that spending will step up a bit in the second quarter because it was lower than what we originally had planned and expected in q one, and that's really the reason why we ended up with $64 a share in EPS in the first quarter. You know, we're gonna 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 gonna get into a 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 and 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 gonna keep doing that.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

And, again, I think we can continue to execute our focused strategy while also doing what we need to do to offset those headwinds that we're facing now in 2025.

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 a multiyear growth opportunity ahead of us based on these new medicines.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Then full year outlook, confident, 8% to 10 raising of the TMTT guidance and being able to offset Yanaval's dilution and basically the tariff impact. We feel good about the year. We feel good about how we are running the company. You.

[Robert Marcus, Analyst at JPMorgan Chase]

Great. Maybe just a quick follow-up. The TMTT guidance range, part of it's FX, part of it's underlying. 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 of progression in the raise guide through the rest of the year?

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

Sure.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

I'll just confirm on FX and then pass over to Devine to talk about just the operational performance and our outlook for the rest of the year. For FX, think about this $100,000,000 benefit that we're getting through the movement in FX rates and just spreading that across our businesses. Probably about half of the increase in TMTT guidance comes from FX and the other half from operational. And then the balance of that hundred million dollars would be spread across the other businesses. Of course, TAVR would would be the biggest place for that to to go.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

Devine, you wanna talk about the other half of the guidance increase?

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

So 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 kinda key drivers both in q one and going forward as we just treat more and more patients. From maybe even I'll give you just the geography component, so it's good to look at that way as well. We see it both coming from both The US and Europe. But, you know, in the in both these markets, PASCAL continues to show its differentiation, and EVOQUE as a new category continues to create treat new patients that don't have great outcomes.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

So we see continued growth happening from that side as well.

[Robert Marcus, Analyst at JPMorgan Chase]

Appreciate it. Thank you very much.

[Operator]

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

[Vijay Kumar, Senior Managing Director at Evercore ISI]

Hey, guys. Thank you for taking my question. Scott, I had a couple of guidance clarifications, if you will. May maybe on the EPS guidance here, you called up the tariff headwinds in in the NFL. Are are we expecting to offset, you know, that incremental ten to fifteen cents of headwinds completely?

[Vijay Kumar, Senior Managing Director at Evercore ISI]

Or or should we be perhaps looking at the bottom half of the guidance range? Just, you know, maybe walk us through on on what the offsets are.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

Yeah. So it's a little premature to to be more precise about where within that two forty to two fifty we may fall. And the reason is because we haven't closed Yenavalve 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 and what we're actually gonna execute.

[Scott Ullem, Corporate VP & CFO at Edwards Lifesciences]

That's why we gave a range, and that's why we think that the two forty to two fifty range in EPS can accommodate different scenarios.

[Vijay Kumar, Senior Managing Director at Evercore ISI]

Understood. And maybe one on international. Japan was a little light, maybe cockroach, you know, trends within Japan.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Yeah. No. Thanks, Vijay, for the question. So for sure, our results 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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 is one is enhancing our capability in the region in Japan to accelerate market growth. One, 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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 situation. So overall, long term in Japan, we see a big potential. Aging population, there is a lot of AS patients, mitral patients, like I said, patients.

[Bernard Zovighian, CEO at Edwards Lifesciences]

So clearly, an opportunity for us, an opportunity to change patient care there.

[Vijay Kumar, Senior Managing Director at Evercore ISI]

Understood. Thank you.

[Operator]

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

[Matt Taylor, Managing Director at Jefferies & Company Inc]

Hi, thanks for taking the question. I did want to follow-up TMTT. I heard your comments. And I guess I just wanted to confirm that none of the guidance range 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 Evoque and tricuspid.

[Matt Taylor, Managing Director at Jefferies & Company Inc]

Should we expect it to be similar? And can you talk about when the European launch will start to contribute and what to expect from The US?

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

Yeah. Sure. This is Devine, Matt. I can take that that question. So first the first part of your question, yes, you're correct that we had built in m three into our 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.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

We'd already kinda built it in. And as we look at this kind of therapy, we're, you know, 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 is is more similar to VOCA in Europe and different than what we see of Vogue in The US. Meaning, as I mentioned, mitral replacement is for patients who are unsuitable for mitral surgery or for tear.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

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 gotta work on that one at a time, and that takes time. Additionally, we gotta train physicians, train our own team, and build it up. So we really see sepidem three in Europe being more of a gradual, long term, important category of adding new patients with mitral disease to be treated.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

And, yeah, hopefully, that's helped.

[Matt Taylor, Managing Director at Jefferies & Company Inc]

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

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

Yeah. So in The US from different than Evoqua in The US, as you can imagine, mitral replacement, again, The US will also have an indication unsuitable for tear or mitral surgery. So, again, these patients are already in the funnel. They may may not be appropriate for surgery or tear. They don't have any other option, and now for many of those patients, m three will be an option.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

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 would be at a slower rate 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 TIER and adding patients to allow us for that kind of multiple years of growth in as we add more add more patients with this new treatment.

[Matt Taylor, Managing Director at Jefferies & Company Inc]

Great. Thank you so much.

[Operator]

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

[Joanne Wuensch., Managing Director at Citi]

Good afternoon, and thanks for taking the question. I just want hit pause on the, 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.

[Joanne Wuensch., Managing Director at Citi]

The expand the number of centers. It could expand maybe something else. And I've also heard from some physicians maybe an expectation that it might eliminate the need for a cardiac surgery team in the 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, you know, procedures start to ramp?

[Joanne Wuensch., Managing Director at Citi]

Thank you.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

Yeah. Thanks, Joanne. You know, I think there's a mult multitude of elements here. The first thing is the label expansion, you know, which obviously is under FDA's control. And, again, we expect that to happen in q two.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

So that's kinda step one. The national coverage decision, you know, that's under the purview of CMS, and, you know, they'll decide, you know, when they wanna reopen that and when they wanna reevaluate it. And, you know, given the safety of TAVR that's been demonstrated in the national registry that we have that really confirms the outstanding results across all of the centers that we we've opened. We do expect there to be an expansion in the number of centers. How many will that be?

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

You know, that's gonna be up to how they write the policy and how that plays out. And and, you know, we'll see how they decide to streamline the team and, you know, try to make the the health care system more efficient. The the third big element is guidelines, which fall under the society purview. And, you know, how do they take this data? How do they update the guidelines so that patients with, you know, severe aortic stenosis but haven't yet pursued the symptoms, how do we make sure that they move through the health care system, they're properly screened, and they're treated in accordance with with what the data suggests?

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

And and I think, you know, we're still in that education process with with a lot of folks. You know, there's sometimes people think that asymptomatic patients are are automatically younger patients. But what we saw in the trial is I think the average age was 76, where for a low risk trial, it was 73. So these aren't necessarily younger patients. You know, we're not necessarily treating them at a much younger age.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

So I think these things are all in important things that we just need to keep reiterating. And, once we have the approval, it really takes the 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, you know, we're just kind of at a standstill beyond what the physicians themselves, the investigators, and, people do at the big medical meetings.

[Joanne Wuensch., Managing Director at Citi]

Very helpful. Thank you.

[Operator]

Thank you. Our next question comes from the line of Pito Chickering with Deutsche Bank. Please proceed.

[Pito Chickering, Analyst at Deutsche Bank]

Hey, guys. I was following up on these NCD questions. You know, our calls with the physicians is that, you know, CMS is actually in sort of final discussions with the societies and health systems about relaxing this entity to, you know, to be certified to have centers and that this change could actually be coming, yeah, in May or in June. Is this timing something that you guys have heard as well?

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

There there's no predetermined timing. You know, it it opens whenever CMS decides that they that they wanna open it, and that is completely within their purview. And no one, frankly, has any influence over that. It's completely within within their their realm of control. So anybody that provides specific timing, they're they're simply speculating as to when they think, you know, when they think that that could happen.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

So I don't I don't have any insights beyond what I've what I've already stated, and and it's gonna be up to them. Again, you know, we do expect that, you know, a new policy I I think 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, you know, I think one of the catalysts in front of CMS is going to be the asymptomatic approval.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

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 all of their constituents could be treated under a national policy. So I expect that to happen again. When exactly is gonna be completely up to them. But when they do, then we get to engage with them.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

We get to start that process and and, you know, hopefully, end up with a policy that, you know, is is going to allow more patients access to life saving therapy.

[Pito Chickering, Analyst at Deutsche Bank]

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 and, or in the process to be trained? Thanks so much.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

No. Sure. This is Devine again. Yeah. So first, in terms of EVOQUE sites, as you can imagine, I think I mentioned before, you know, we started originating those first fifty or 60 clinical trial sites.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

And then from that, I mean, 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 if you're interested in a trial site, it's it's at least a couple months away. So it's 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 in the ramp.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

And this really, as you know, has to do with the the value proposition where people are seeing how the elimination of TR with Evoke is really changing patients' lives. And as 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 it's a very big number. And, our goal is some some number of those would be great for tricuspid treatment, including Evoque, 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.

[Pito Chickering, Analyst at Deutsche Bank]

Great. Thanks so much.

[Operator]

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

[Chris Pasquale, Partner - Medical Devices & Supplies at Nephron Research LLC]

Thanks. The two point six percent surgical growth this quarter was the source we've seen from that business in a while. Know selling days had a bit of an impact. Can you just talk about your confidence in being able to sustain mid single digit growth in that segment, especially now that resilient platforms have really become dominant in many of your big markets and you don't have as much of a tailwind from mix?

[Wayne Markowitz, GM & Senior VP of Surgical Structural Heart at Edwards Lifesciences]

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. And I think looking forward in 2025, as you heard from Bernard, we're launching Mitra in China. We've got some other potential tailwinds later on this year with the approval of Connect in Europe.

[Wayne Markowitz, GM & Senior VP of Surgical Structural Heart at Edwards Lifesciences]

And so we are remaining confident in our current guidance in the mid single digit range for 2025.

[Chris Pasquale, Partner - Medical Devices & Supplies at Nephron Research LLC]

Great. That's helpful. And and I know this may be a bit difficult to answer given that the deal isn't closed yet, but we saw some updated data from the Align AR trial at ACC. Continues to look solid. We're about eighteen months out now from the original data presentation.

[Chris Pasquale, Partner - Medical Devices & Supplies at Nephron Research LLC]

Just any help you can give us in terms of what we should expect for a regulatory pathway and approval timing for that product.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

Yeah. Actually, we don't have anything that we can talk about on that. You know, we're sort of pencils down until the deal closes. So we don't have any direct knowledge. You know, we're not in conversation with them.

[Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart at Edwards Lifesciences]

Until the deal closes, you know, we're we're sort of on the outside looking in. So I don't have any more information than what you saw presented at ACC.

[Chris Pasquale, Partner - Medical Devices & Supplies at Nephron Research LLC]

Alright. Thanks.

[Operator]

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

[Patrick Wood, Managing Director at Morgan Stanley]

Beautiful. Thank you so much, guys. I guess maybe on Pascal, doing pretty well. You know, where are we at in terms of, you know, account sort of breadth versus depth? I'm thinking, like, is the utilization sort of where you would like it to be?

[Patrick Wood, Managing Director at Morgan Stanley]

I'm I'm trying to work out how wide you are versus how deep within individual accounts.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

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. And that and 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 wanna use it more. And then as you can imagine, they then tell their friends through different types of programs at congresses so that sites who today who don't use PASCAL are interested in trying in to use it.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

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 US. Again, I'm able to use the the generic calendar. If there are 850 TAVR centers, give or take, in The US 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.

[Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies at Edwards Lifesciences]

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.

[Patrick Wood, Managing Director at Morgan Stanley]

Thanks, Steven. That's helpful. And then very quickly, there's been a lot of sort of shuffle around with the FDA overall and and people five 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?

[Bernard Zovighian, CEO at Edwards Lifesciences]

Yeah. Obviously, 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, all of that. So we feel like people at the FDA are very professional. They are very committed to the space, and we don't see an impact.

[Bernard Zovighian, CEO at Edwards Lifesciences]

And we don't believe we will see an impact. But obviously, is a fluid situation that we need to monitor.

[Patrick Wood, Managing Director at Morgan Stanley]

Awesome. Thanks, Bernard.

[Operator]

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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Yes. So thank you, everyone, for your interest. So beyond the strong start of the year, 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, we are on track to get an early TAVR indication approval in Q2. We had an NCD for EVOQUE, SAPIEN M3CMARK, which basically represents the start of a new category for us.

[Bernard Zovighian, CEO at Edwards Lifesciences]

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 heart patients and we are continuing to target 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.

[Bernard Zovighian, CEO at Edwards Lifesciences]

Thanks for your interest in the company. And if you need any questions, do not hesitate to call CDA, Mark, Scott or myself. Have a great rest of your day. Thank you.

[Operator]

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

Participants

Executives

• Mark Wilterding, SVP, IR and Treasurer
• Bernard Zovighian, CEO
• Scott Ullem, Corporate VP & CFO
• Daveen Chopra, Corporate Vice President of Transcatheter Mitral & Tricuspid Therapies
• Larry Wood, Corporate VP and Group President of TAVR & Surgical Structural Heart
• Wayne Markowitz, GM & Senior VP of Surgical Structural Heart

Analysts

• Lawrence Biegelsen, Senior Medical Device Equity Research Analyst at Wells Fargo
• David Roman, Managing Director at Goldman Sachs
• Travis Steed, Managing Director - Equity Research at Bank of America
• Robert Marcus, Analyst at JPMorgan Chase
• Vijay Kumar, Senior Managing Director at Evercore ISI
• Matt Taylor, Managing Director at Jefferies & Company Inc
• Joanne Wuensch., Managing Director at Citi
• Pito Chickering, Analyst at Deutsche Bank
• Chris Pasquale, Partner - Medical Devices & Supplies at Nephron Research LLC
• Patrick Wood, Managing Director at Morgan Stanley