Edwards Lifesciences Corp Q4 2024 Earnings Call Transcript

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

Question: David Roman - Goldman Sachs - Analyst : Thank you, and good afternoon, everybody. I wanted just to start on the TMTT side. Maybe you could my first question. Just help us reflect a little bit on some of the dynamics that drove the performance here in 2024 that ended above your expectations. And then what needs to unfold operationally still to see an acceleration from the $420 million where you're annualizing in Q4 up to the $500 million plus over -- that's reflected in your guidance here.

Question: David Roman - Goldman Sachs - Analyst : And then maybe just for my follow-up here. I'm trying to piece some of this together between how you exited Q4 and then the Q1 guidance calling for revenue growth, both in TAVR and total company below the low end of the ranges here. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 11, 2025 / 10:00PM, EW.N - Q4 2024 Edwards Lifesciences Corp Earnings Call Because when I just reflect on Q4, you had the hurricane dynamic early in the quarter, but you also had the exit of Boston Scientific pressures in Europe, not the exit, but the pressure on their business that they described. You're seeing EVOQUE and PASCAL launch. So just as I think about the business here, Q4 versus the dynamics that you're calling here in Q1, maybe you could just help us piece together the sequential deceleration and then correspondingly, the acceleration reflected in the full-year outlook?

Question: David Roman - Goldman Sachs - Analyst : Great Thanks for all the color.

Question: Robert Marcus - JPMorgan - Analyst : Great. Congrats on a nice quarter and thanks for taking the question. First for me, maybe a P&L question as we think about 2025. Scott, the mix of operating expense came in a bit different than The Street was thinking. Any color you could give us now with the rebased business ex critical care, how we should be thinking about SG&A and R&D each separately to get to the guidance you provided? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 11, 2025 / 10:00PM, EW.N - Q4 2024 Edwards Lifesciences Corp Earnings Call

Question: Robert Marcus - JPMorgan - Analyst : Maybe a follow-up, Bernard, you mentioned in the script, there were a few instances of regional pressure. You still came in above The Street on TAVR. Maybe you could just speak to the regional pressures and how transient or permanent they are and also highlight some of the areas of strength.

Question: Robert Marcus - JPMorgan - Analyst : Thank you very much.

Question: Larry Biegelsen - Wells Fargo Securities - Analyst : Good afternoon. Thanks for the quesiton. And Daveen, congrats on a really nice quarter in TMTT and Edwards, overall. So I wanted to start with you, Daveen. That's why I pointed that out on EVOQUE, what have you seen since the NTAP started on October 1? And how are you thinking about the impact from the NCD, which should be finalized in March? And I had one follow-up.

Question: Larry Biegelsen - Wells Fargo Securities - Analyst : That's helpful. And one for Larry. Just it would be great to hear you talk about what you're seeing and hearing in the field following early TAVR. -- when do you expect the data to positively impact procedures? Is it the indication? Is it guidelines? What do you need? Or is it just everything contributing?

Question: Larry Biegelsen - Wells Fargo Securities - Analyst : Thanks, Larry.

Question: Pito Chickering - Deutsche Bank - Analyst : Good afternoon, guys. Following up on Larry's question there. Beyond the US hospitals that were part of the trial, like how many more hospitals have been trained to implant EVOQUE at this point? And any color on how many doctors at this point, including those during the trials have been trained? And I guess how many are signed up at this point to be trained at this going forward?

Question: Pito Chickering - Deutsche Bank - Analyst : Right. As TMTT is becoming a bigger part of the revenue engine for you guys. Can you give us a US OUS split for TMTT in the fourth quarter, so you need that as a launch pad for modeling 2025?

Question: Pito Chickering - Deutsche Bank - Analyst : Thank you.

Question: Travis Steed - BofA Global Research - Analyst : Congrats on the good quarter. I just wanted to follow up on the Q1 guidance. You said TAVR growth below 5% to 7%. Just want to confirm first that, that 5% to 7% is constant currency. And I know there's a selling day headwind. If you could just quantify that if it's 150 basis points. And excluding the selling day, are you back into that 5% TAVR guidance range?

Question: Travis Steed - BofA Global Research - Analyst : Great. That's helpful. And then the second question, just so we could get an update on CLASP IIF and CLASP II TR, the functional mitral repair and tricuspid repair products. Just curious how those trials are going and timelines for that opportunity?

Question: Travis Steed - BofA Global Research - Analyst : Great. Thanks a lot.

Question: Vijay Kumar - Evercore ISI - Analyst : Hey, guys. Thanks for taking the question and congrats on a nice TMTT print. Maybe my first question back on the guidance here for Q1. I think Q4, when we look at the TAVR number, there were a number of one-off items, right? I think you had three lesser days, maybe some hurricane impact to have some China noise. I guess why all of that, I think Q4 came in above expectations at five, given some of those items won't repeat, why shouldn't Q1 be better? Is there any one-offs outside of the extra day -- 1 lesser day that we should be thinking of?

Question: Vijay Kumar - Evercore ISI - Analyst : Understood. And Bernard, maybe my follow-up for you. I think you noted NCD language around tricuspid was in line with expectations. I think there is a CED criteria. And when I look at the physician criteria, there is a cross-pollination collaboration between a variety of physicians rate. It seems a little bit more onerous versus when you look at the TAVR guidelines. So curious how we're thinking about the NCD proposals? And do you expect any changes to the proposed language?

Question: Vijay Kumar - Evercore ISI - Analyst : Thanks for clarifying.

Question: Rick Wise - Stifel Nicolaus & Co Inc - Analyst : Good afternoon, everybody. Sorry, I'm in the airport, it might be a little noisy. I want to follow up one more time on the first quarter TAVR guidance and early TAVR. Scott, I just want to be clear in my own mind. When you gave us guidance at the Analyst Day, obviously, you were thinking about the quarters of '25. Is your -- have you shaded your TAVR expectations in some way with your comments and guided in the first quarter, is it any different than it was as the year set up, as you thought it would be back in December when we talked. And then I'll follow up on early TAVR.

Question: Rick Wise - Stifel Nicolaus & Co Inc - Analyst : Okay. And Larry, just not to go over, you've been very clear, but perhaps you saw the work I did on early TAVR, just didn't tried to trona it that a bunch of docs said that they're already starting to see an increase in referral volumes. And just to ask you, even though it might be early, are you seeing -- are you hearing the same thing that I heard? I mean, obviously, as the year unfolds and as you -- as education expands, there's going to be more. But are you seeing that same impact that, that small sample that I wrote about articulate.

Question: Rick Wise - Stifel Nicolaus & Co Inc - Analyst : Thanks, Larry. Thanks, Scott.

Question: Matthew Miksic - Barclays Capital - Analyst : Hey. Thanks so much for taking the question. I just have one follow-up on an earlier question. First, just around centers. I know you're growing out of the initial triennial trial centers for EVOQUE. I'm just wondering if you have like a round number that you think this can go to Teverson centers like the 850. Is this over time, half of that? Is there a one-third of that, an actual number that we should just think about as getting to? And I have 1 quick follow-up if I could.

Question: Matthew Miksic - Barclays Capital - Analyst : Got it. And then the follow-up, just very closely related. Some of the feedback we had conversations with clinicians last year who did the launch and is obviously excitement about having to valve, but then we identify these patients, how many can you get in, the time to do the procedure, the reimbursement for the procedure, times of training, all these kinds of early start-up factors. Maybe if you could talk a little bit about how you see this year your ability to start mitigating some of those early start-up challenges in getting volumes going and adoption going, et cetera? Thanks so much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 11, 2025 / 10:00PM, EW.N - Q4 2024 Edwards Lifesciences Corp Earnings Call

Question: Matthew Miksic - Barclays Capital - Analyst : Very helpful. Thanks.

Question: Matthew Taylor - Jefferies LLC - Analyst : Hi. Thanks for taking the question and congrats on a nice quarter. I wanted to ask a follow-up question on growth in TMTT in 2025. I know you don't give all the details of US, OUS, or mitral tricuspid, but I was wondering if you could give us any framework or guidepost to help us understand how much growth is coming from those different sources? Or are they growing similarly? Maybe if you could talk about share expectations in those different markets? Anything like that would be helpful to think about modeling?

Question: Matthew Taylor - Jefferies LLC - Analyst : Great. Thank you, guys.

Question: Joanne Wuensch - Citi Investment Research - Analyst : Good evening and thank you for taking the question. Can we pause for a second on M3? It sounds like it's on track for CE Mark approval near the end of the year with some revenue contribution and then you're going to have data at TCT 2025. Can you remind us what that market opportunity is and why that's an important product in the portfolio?

Question: Joanne Wuensch - Citi Investment Research - Analyst : No, I'm good. That was awesome. Thank you so much. Have a great night.