The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Great. Bernard, maybe we could start with TAVR. You had positive asymptomatic data at TCT last year. You have the moderate risk trial coming
next year. Maybe speak to how you view the evolution of TAVR from this point with those two trials, assuming progress next year is positive. How
does that open up the patient population? And then on top of that, sort of what does Edwards need to do to make sure that there's enough room
in the system for everybody to be treated?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Some of the doctor feedback I heard on the asymptomatic trials that you actually ran it too well, that there was too quick a turnaround from
identification of symptoms to treatment. And so it doesn't actually reflect the real-world results of the control arm. What's the feedback you're
getting from doctors? And do you think the trial is going to be enough to make sure that doctors treat all patients regardless of symptoms?
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JANUARY 14, 2025 / 7:15PM, EW.N - Edwards Lifesciences Corp at JPMorgan Healthcare Conference
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: You're expecting approval for asymptomatic middle of the year. Do you think that will be an Edwards-specific approval? Or do you think that will
be applicable to TAVR in general?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: One of the things we've heard over the past few years is lifetime management of the patient and valve management. You introduced RESILIA,
which has the anticalcification material that allows for longer durability. Where does that stand in the evolution of that discussion? And how does
SAPIEN X4 fit into that?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: I think it's fair to say TAVR was the key growth driver for Edwards. It's still a growth driver, but the future is going to be more in TMTT, where the
untapped potential really sits. And let's start with tricuspid and EVOQUE. This, you launched last year. You're the only approved tricuspid replacement
device on the market. Maybe speak to the performance you've seen of that so far since launch and what the ultimate opportunity is for EVOQUE.
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Bernard, you mentioned very specifically Gen 1, Gen 2, Gen 3. If I think about 10 years ago, the SAPIEN valve compared to SAPIEN 3 Ultra RESILIA
today, it's sort of almost criminal to think about that was going in the body at the time. Is that sort of the pathway of evolution we should expect
with EVOQUE and that kind of progression of size and performance over time?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: You made the interesting comment that TEER and EVOQUE don't overlap. Repair and replacement are separate populations. I know that's been
an evolving discussion. Do you think the clinical community is at a point now where they have a clear definition of what device is applicable, which
population?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: I imagine tricuspid comments. Is it also the same in mitral where not far away in the heart, but very different procedure, very different procedure
times and access? So maybe talk about the efforts, Edwards is undergoing in mitral replacement. You already have PASCAL approved for mitral
repair. But talk about mitral replacement, something we're going to start to see more from 2025.
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Maybe if I could pivot a little bit, Scott, M&A is not something we've really talked about in past years here. Yet you've had multiple acquisitions and
you sold the Critical Care business. So maybe now that most of those portfolio moves are completed, how are you thinking about just the portfolio
at Edwards and M&A in general moving forward from this point?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Congratulations on the NCD for remote heart failure monitoring. Maybe just talk to how heart failure monitoring fits into this. I know heart failure
is part of mitral and tricuspid valve disease. So there is a near adjacency. But how does that fit into the strategy? And is there more room to go in
heart failure overall?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Maybe if I turn to financials, something I didn't hear you talk about at the Analyst Day was just as we lay out 2025, and I'm looking at the quarters
and my model have a very difficult comp in first quarter, I think you have an extra selling day and then maybe a little easier comp in fourth quarter
with some of the hurricane impact if we end up seeing that in fourth quarter.
How should we think about the cadence of growth? I know you have the 8% to 10% overall for the company. But is there any plus or minuses in
different quarters of the year?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Got it. Understood. Maybe if I walk down the P&L, you talked about all the investments you're making in clinical trials. I think you're by far the most
heavily invested in, I guess, innovation of evidence or discovery of evidence in this space.
How should we think about -- you talked about leverage down the P&L, double-digit EPS growth in a position moving forward in '26. How should
we think about some of the levers down the P&L? And is that scaling back investment in evidence generation? Or is it coming from somewhere
else in the P&L?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Is that a sustainable type of mid-single versus high single? Is that kind of leverage possible on a go-forward basis? Or is it all onetime in nature?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Great. Well, we're out of time. Thanks for a great discussion. Thanks, everyone, for attending.
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JANUARY 14, 2025 / 7:15PM, EW.N - Edwards Lifesciences Corp at JPMorgan Healthcare Conference
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