Edwards Lifesciences (NYSE:EW) held its first-quarter earnings conference call on Thursday. Below is the complete transcript from the call.
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View the webcast at https://event.webcasts.com/starthere.jsp?ei=1756419&tp_key=ec72b2f736
Summary
Edwards Lifesciences Corp reported strong quarterly performance with notable growth in their TAVR business, driven by market expansion and some share gains.
The company is optimistic about its Sapien X4 pipeline, noting potential enhancements and a confirmatory trial expected to continue through 2026.
Guidance has been raised for TAVR for the year, attributed to better than expected Q1 results and overall market growth.
Management emphasized a focus on realistic and transparent guidance, taking into account previous year’s performance and upcoming challenges.
The company highlighted its strategic focus on mitral and tricuspid valve solutions, projecting growth opportunities and aiming to create new treatment categories.
Edwards Lifesciences Corp completed a significant share repurchase, reflecting confidence in long-term investment value.
The healthcare environment was described as favorable, with recent positive regulatory developments for breakthrough therapies.
Management is actively searching for a new CFO, with the process reportedly progressing well.
Full Transcript
OPERATOR
We try not to focus too much on share because share is a lagging indicator. Share is never driving a business. You know, we as a company, we bring data, we bring evidence, we bring, you know, best innovation to bring to physician, best tools, best solutions so they can take care of their patients. And therefore, you know, everybody is benefiting. So that’s the way we are thinking about it now. Everything that you have seen in the guide, everything that we talk about is in the guidance today. And what we try to do with our guidance is to give you a realistic guidance based on what we know today. So what you talked about happening in mid February and we gave you the best of what we know today. Providing realistic guidance is very important to us. Larry, thank you for the question. All right.
Larry
Hey, Bernard, just for my follow up, it’s been a while since since December, since we heard about Sapien X4. Could you give us a little bit of an update? You talked about confirmatory clinical work. Where does that stand? Thanks for taking the question.
Bernard
No, thank you. Thank you. Thank you, Larry. So I’m going to ask Dan, you know, who is very close to this to give you an update on this platform? Yeah. Hi, Larry.
Dan
Thanks for the question. Clearly, we’re pretty excited about our to have a pipeline in general which includes X4. X4 is a potential game changer for us, especially on the concept of personalized valve sizing. You know that we’ve set a very, very high bar with SAPIEN 3 Ultra Resilia that continues to differentiate. And we see that in the data that we’re just talking about, not only our own data, but also relative to competitive data. We talked about in December that when we put X4 in a clinic, we immediately started to see things that we would think like, hey, if we had the opportunity to enhance that product, we should take it. And we are. And that has to go into a confirmatory trial. And so we’re going to be collecting that evidence through 2026. And when we’ve completed that, we’ll have more to say about the X4 product and the timelines and all those sorts of things. So that’s exactly where we’re at.
OPERATOR
Thank you. Your next question comes from Travis Steed with Bank of America. Please state your question.
Travis Steed (Equity Analyst)
Hey, congrats on a good quarter. Maybe ask about capacity. You’ve had more left atrial appendage closure procedures shifting towards EP. What are you seeing from a capacity standpoint for structural heart doctors when you’re in the field? And are you seeing any kind of benefit on the numbers in the market.
Bernard
Thanks for the question. Capacity has not been an acute matter in the last few quarters. What we have seen is health systems in the US have done a great job managing capacity. They look at their processes, they look at their staffing, they look about how to turn the room faster in between patients. So we have been quite impressed by all what we have been doing and obviously we are there also to support them. But maybe I can add Davine and Dan to add some color here if you have seen anything.
Davine
Yeah, this is Davine. I’ll just make one comment. I think the agility that you talked about, Bernard, is especially true as you start a new therapy like TMTT right when you start like M3 or Evoke, you start taking up lab space. But what we’ve seen is, at least from our standpoint is that as they put in new lab time, they’ve worked across the system to ensure that they’re not taking away from a place like TAVR or something else. From what we’ve seen, they’ve continued to be agile and figuring out, hey, how do we get an extra shift in, how do we get an extra lab running, how do we do other things like that. So that’s been pretty consistent in what we’ve seen as centers get going in TMTT.
Dan
And if I just added from my side, I think it’s the right point. It’s different from hospital hospital, you know, but from a TAVR perspective I think what really helps is that it’s clearly a priority procedure and that’s, you know, based on the evidence. And so there is that ability to navigate some of the acuteness of, of various hospital challenges. We’re on the ground every day with the hospitals trying to understand what their specific issues are, if they have them and how, if anything we can help. But it’s something that we pay close attention to all the time.
Travis Steed (Equity Analyst)
Helpful and then maybe a follow up on the ncd. There’s a lot of stuff in the proposed NCD Centers for Heart Team. Just curious if you think it’ll all go through as proposed and how important are you each of those things in the NCD proposal? And I had a lot of questions on is the US TAVR, was it high single digits or double digits, if you’d answer that too.
Bernard
It is very tough to predict what the final NCD will be. You know that we are very pleased CMS opened the process. The first phase is over. So basically now we are waiting for, you know, I think in a mid June, you know, to get what the draft NCD will be our position, I believe is, you know, fact based in the interest of a patient to make sure they have, you know, a fast access to care. But again, you know, the decision we rely on CMS, that’s on the NCD. What’s the second part of your question?
Travis Steed (Equity Analyst)
Did US TAVR, was it high single digits or double digits this quarter and reviewed titrate between the two?
Bernard
Yeah, we don’t like to give this kind of specifics. So globally TAVR grew 11%. What we said is that TAVR in the US was healthy and at the ous TAVR grew even faster. So I’m sure she can do some math here.
Travis Steed (Equity Analyst)
Fair. Thank you.
OPERATOR
Your next question comes from Robby Marcus with JPMorgan. Please state your question.
Robby Marcus
Great. Thanks …
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