Edwards Lifesciences Corp Q1 2025 Earnings Call Transcript

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

Question: Larry Biegelsen - Wells Fargo Securities - Analyst : Congrats on a good start to the year here. And Scott, you can probably anticipate the first question. You're maintaining the EPS guidance despite the tariffs and the JenaValve acquisition and maybe even currency. 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 have one follow-up.

Question: Larry Biegelsen - Wells Fargo Securities - Analyst : That's very helpful. And a follow-up for Daveen on tricuspid. Congratulations on the NCD for EVOQUE. How do you see the NCD impacting the ramp of EVOQUE?

Question: David Roman - The Goldman Sachs Group, Inc. - Analyst : 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. Then I have one follow-up.

Question: David Roman - The Goldman Sachs Group, Inc. - Analyst : Got it. 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 toolbox approach for physicians or you think it converts to a one size fits all, be it in mitral or tricuspid? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 23, 2025 / 9:00PM, EW.N - Q1 2025 Edwards Lifesciences Corp Earnings Call

Question: Travis Steed - BofA Global Research - Analyst : Congrats on the quarter. First question I wanted to ask on TAVR capacity constraints and the potential for the TAVR, NCD [loosened] some of the requirements or essentially broadened some of the number of centers available to treat and some of the ways that some of the capacity constraints could be eased over time.

Question: Travis Steed - BofA Global Research - Analyst : Great. That's helpful. And then I have a follow-up, just a modeling question on Q2 TAVR. I think the Street said 5.8%. Just curious if there's any color you want to provide on how to model Q2 TAVR in the remainder of the year in the second half? And any days benefit to kind of call out over the course of the year for the remaining portion of the year?

Question: Robert Marcus - JPMorgan Chase & Co. - Analyst : Great. Good quarter. Two for me. Scott, maybe just on the EPS offsets, offsetting $0.10 to $0.15 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 JenaValve dilution.

Question: Robert Marcus - JPMorgan Chase & Co. - Analyst : Great. Maybe -- just a quick follow-up. The TMTT guidance range. Part of it is FX, part of its 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.

Question: Vijay Kumar - Evercore ISI - Analyst : Scott, I had a couple of guidance clarifications, if you will. Maybe on the EPS guidance here, you called out the tariff headwinds in JenaValve. Are we expecting to offset that increment, $0.10 to $0.15 of headwinds completely? Or should we be perhaps looking at the bottom half of the guidance range, just maybe walk us through on what the offsets are.

Question: Vijay Kumar - Evercore ISI - Analyst : Understood. Maybe one on international. Japan was a little light maybe talk about trends within Japan.

Question: Matthew Taylor - Jefferies Financial Group Inc. - Analyst : 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 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 in tricuspid? 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 ?

Question: Matthew Taylor - Jefferies Financial Group Inc. - Analyst : That's great. And then maybe you could just finish with the US, how that will be different?

Question: Joanne Watson Wuensch - Citi Investment Research - Analyst : I just want to 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. NCD could expand the number of centers include expand maybe something else? And I've also heard from some decisions may be an expectation 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?

Question: Pito Chickering - Deutsche Bank - Analyst : Following up on these NCD questions. Our call is that the physicians is that CMS is actually in sort of final discussions with the societies and the health systems about relaxing this entity to be certified (technical difficulty) centers and that this change could actually be coming in May or in June. Is this timing something that you guys have heard as well? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 23, 2025 / 9:00PM, EW.N - Q1 2025 Edwards Lifesciences Corp Earnings Call

Question: Pito Chickering - Deutsche Bank - Analyst : Great. Then a follow-up here. Can you guys give us an update on how the demand for training for EVOQUE going? And any color on how many sites have been trained? And -- or in a process to be trained?

Question: Christopher Pasquale - Nephron Research LLC - Analyst : The 2.6% 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. Can you just talk about your confidence in being able to sustain mid-single-digit growth in that segment, especially now that the RESILIA platforms have really become dominant in many of your big markets that you don't have as much of a tailwind from mix. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 23, 2025 / 9:00PM, EW.N - Q1 2025 Edwards Lifesciences Corp Earnings Call

Question: Christopher Pasquale - Nephron Research LLC - Analyst : Great. That's helpful. And 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, 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?

Question: Patrick Wood - Morgan Stanley & Co LLC. - Analyst : I guess maybe on PASCAL, doing pretty well. Where are we at in terms of accounts sort of breadth versus depth? I'm thinking like, is the utilization sort of where you would like it to be? I'm trying to how wide you all versus how deep within individual accounts.

Question: Patrick Wood - Morgan Stanley & Co LLC. - Analyst : That's helpful. And then very quickly, there's been a lot of sort of shuffle around of the FDA overall and people fire, rehire that sort of things. Is there any expectation from you guys that approval time lines, long term could be affected or anything like that? Or is this a short-term noise that we can ignore.