Edwards Lifesciences Corp at TD Cowen Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Joshua Jennings - TD Cowen - Analyst : Thank you for handling that a multi-tiered question so effectively. I mean I wanted to -- and just on 2025, you guys have issued [8-10] corporate-wide fourth quarter and TMTT contributed stronger than expected. TAVR was kind of as expected to a degree. And wanted to just start on the transcatheter mitral and tricuspid franchise and then tricuspid specifically, the EVOQUE launches, you guys continue to be methodical and have success and drive new account penetration and volume growth. And I wanted to just review just your outlook on the tricuspid market. You have another tool that you're going to introduce into the Edwards toolbox with PASCAL TR down the line. Maybe just talk about that market, early launch trends, just both on the repair and replacement side. And can we see this market evolve into a $1 billion to $2 billion market in the next 5-plus years?

Question: Joshua Jennings - TD Cowen - Analyst : And maybe just for a couple of more questions on the tricuspid franchise. Just as we think about and we've heard from clinicians as others have to just about there's going to be learnings in the real world experience, patient selection is a big one and honing in on which patients will benefit most from tricuspid, particularly, a replacement that also repair. And as we think about that and then it's procedural efficiencies. I mean, what are the next steps just on the data front to help the clinical community kind of become more effective in patient selection and potentially also show outcomes. I think you're going to continue to follow up on TRISCEND II in terms of may see a mortality benefit at some point in Year 2, Year 3 or 4, I mean, we don't know. But any other clinical evidence build-out that we should be expecting for EVOQUE.

Question: Joshua Jennings - TD Cowen - Analyst : And just from the workflow perspective, I think CT Edwards team evaluates and then has a team to schedule a procedure and guide the provider team to make sure the procedure goes well and that they're delivering the best outcome as possible. How does that all evolve? Do we ultimately see centers evaluating their own CT results and sizing of the EVOQUE valve or determining whether the patient is a candidate and does that effort from the the clinical team from Edwards -- is it the manpower or womenpower get reduced at some point? And how do you see that evolving?

Question: Joshua Jennings - TD Cowen - Analyst : And maybe to last question on the tricuspid replacement front. It sounds like from fourth quarter update at the Investor Day earlier late last year that the Edwards team is as excited about the tricuspid replacement opportunity in these early days of the commercial launch as you were prior to approval. Is that the right assessment of the team's sentiment towards the EVOQUE opportunity in tricuspid replacement. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 04, 2025 / 2:50PM, EW.N - Edwards Lifesciences Corp at TD Cowen Healthcare Conference

Question: Joshua Jennings - TD Cowen - Analyst : And you guys have PASCAL TR in the pipeline. Maybe just help us refresh us on how you guys are looking at the potential split. I mean there's a lot of learning still. It's still early days. And with the repair and replacement device and commercial use currently. But is it a 50-50 split replacement versus repair? Do you think it could be 60-40 because of the quality of life benefits and the complete elimination of TR on the replacement side. . in the out years, it doesn't matter to Edwards because you're going to have devices for both buckets, but maybe talk about how you see the market evolving and how Pascal TR is going to be a big addition to the tricuspid toolbox.

Question: Joshua Jennings - TD Cowen - Analyst : Excellent. And just to remind us of the time lines of PASCAL TR when we could see US approval or data and then submission.

Question: Joshua Jennings - TD Cowen - Analyst : Excellent. And thinking about PASCAL for mitral tear you guys -- it seems as if you're gaining traction in the marketplace, taking share. We had some positive feedback from some intervention cardiologists yesterday on a structural heart panel that we hosted that Pascal was accounted for 80% plus share at their centers. Maybe just talk about the share capture trajectory, where -- I mean, it's been -- we're getting deeper into the launch, but where the commercial effort stands and how you expect PASCAL'S share position to ultimately play out? Could you become the market leader over time?

Question: Joshua Jennings - TD Cowen - Analyst : And just on the two different indications for mitral tear degenerative and functional Class II continues to enroll. Any updates on that trial and ultimately unlocking that functional indication, which represents a bigger piece of the mitral repair opportunity.

Question: Joshua Jennings - TD Cowen - Analyst :

Question: Joshua Jennings - TD Cowen - Analyst : No problem. SAPIEN M3, you guys have made a lot of progress in that clinical development program for mitral replacement. Maybe a similar question that I proposed for the tricuspid market [ultimate]. I mean I think mitral [TEER] has been in place for a while. I think the assumption from our team, and I think the consensus view is that repair will the dominant approach for a while going, but there are a significant number of patients that could benefit from replacement. Maybe just talk about that that opportunity for M3 and what it can do for the TMTT franchise? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 04, 2025 / 2:50PM, EW.N - Edwards Lifesciences Corp at TD Cowen Healthcare Conference

Question: Joshua Jennings - TD Cowen - Analyst : And just in terms of market growth for just mitral -- transcatheter mitral interventions, maybe a little bit slower than the most optimistic view a couple of years ago. Some of that's been referral channel dynamics for the functional mitral regurgitation indication with the heart failure community, but more data will accrue -- should we be expecting acceleration with replacement -- replacement technologies like SAPIEN M3 and then just more real-world data, but also some data that could be moving down the risk curve to open up indication for more patients?

Question: Joshua Jennings - TD Cowen - Analyst : Great. And then just moving into TAVR, which is still an awesome growth opportunity, a huge market. You touched on the symptomatic indication label update. And I think guideline updates later in the year being a driver for deeper penetration into that new opportunity. If you wanted to -- I mean we've been just in our checks over the last couple of years with interventional cardiologists, there have been this element of potentially a symptomatic [creep]. Do you think that's been in play? And has that muted any kind of push in the market just post data presentation? Or should we be thinking that the clinical community interventional cardiology community and surgeon community waiting for this label to expand and guidelines to be put in place?

Question: Joshua Jennings - TD Cowen - Analyst : If we think about the market and the potential acceleration, symptomatic's one driver, just have a study for moderate aortic stenosis is another. We've got the TAVR and TAVR replacement cycle that could come at some point as some of these low-risk patients continue to survive out 5 and 10 years. But maybe on the moderate aortic stenosis indication and the efforts there, sizable opportunity and could be massive, could be just as REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 04, 2025 / 2:50PM, EW.N - Edwards Lifesciences Corp at TD Cowen Healthcare Conference big as the severe aortic stenosis opportunity from a patient prevalence standpoint or if there's some modifications, but to -- or just patient selection criteria that are put in place based on the data that's shown. But I mean how has Edwards [sentiment ivolved] towards the expansion opportunity in moderate AS fared over the last year and you guys have been rolling the trial. You haven't seen data yet, but maybe just help us understand the evolution of Edwards team's view on this new indication. It's not that far away, right?

Question: Joshua Jennings - TD Cowen - Analyst : And just moving on to the TAVR and TAVR opportunity. I think Edwards has been super vocal and maybe that's because the TAVR and TAVR segment is still represents roughly 1% of the market is by our calculation the data that we have. But we are moving further and further out from low-risk approval and patients are surviving longer, still yet to be determined the durability of TAVR platforms, including SAPIEN and that could be extended out through past 10 years. But how are you guys thinking about the replacement market. It's not going to be a big tailwind and for the market or for Edwards in 2025? But when do you think we could see that kick in? I think Dr. [Genaro] did some equity research analysis of the presentation on the aortic valves last year, and I think represented at the TCT just forecasting with assumptions on durability, some pretty healthy volumes for the TAVR and TAVR segment as we get out into the late '20s and then into the early 30s.

Question: Joshua Jennings - TD Cowen - Analyst : Great. And thinking about competition, Edwards has had a monopoly on the or exclusivity, I should say, in the balloon expandable TAVR segment, there's some development programs from Anteris from Abbott, I think, [Mytrus] and maybe even Medtronic to develop balloon expandable systems as well. But you guys aren't standing still. Maybe just talk about how the SAPIEN 3 Ultra RESILIA valve can progress when we got SAPIEN X4 in development, and we may see data soon. And then I think you guys have shared that there's -- obviously, you're working on future generation valve beyond X4 down the line. But anything new REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 04, 2025 / 2:50PM, EW.N - Edwards Lifesciences Corp at TD Cowen Healthcare Conference to share? I know you gave a breakdown at the Investor Day, but I'd love to just maybe review that and how the SAPIEN platform progresses from here.

Question: Joshua Jennings - TD Cowen - Analyst : There are attempts to compete in the balloon expandable segment. Edwards in years past had a development program for a self-expanding valve. Is at a potential R&D effort, if others are trying to kind of encroach on self -- balloon expandable territory? Could Edwards go back and develop a self-expanding valve. I would say -- but that would not be on the top of my list of to-dos for Edwards. But I just want to throw the question out there.

Question: Joshua Jennings - TD Cowen - Analyst : Thinking about some of the strategic moves you've made on the acquisition front. You continue to generate strong cash flows, strong balance sheet. Maybe talk us through the the capital allocation strategy going forward. And our assumption is, you're going to continue to build out your market-leading structure of heart portfolio, but would love to just hear any updates in terms of how you guys are thinking about capital allocation going forward?

Question: Joshua Jennings - TD Cowen - Analyst : Excellent. Maybe we can just end on just reiterating the kind of LRP target of getting back to to 10% organic revenue growth now in the new Edwards era ex critical care, 90% in 2024 despite experiencing some turbulence in the TAVR market. TMTT is going stronger. You have these new -- aortic regurgitation and interventional heart failure. But how should we be thinking about the breakdown? I mean could TAVR continue to chug along in this mid- to high single-digit range in TMTT and the new products driving incremental growth and getting Edwards to 10%.

Question: Joshua Jennings - TD Cowen - Analyst : Excellent. It's an exciting trajectory a lot in front of you, looking forward to tracking all the progress this year and then beyond. Scott, Mark, thank you guys so much for joining again, and have a great day.