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: Travis Steed - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Hey, congrats on a good quarter. Maybe to start with the TAVR growth in this quarter, the 10.6%. It sounded like just a modest
contribution from the Boston exit. So if you can just maybe talk about some of your underlying trends and what was the strength
this quarter? And is this kind of full year TAVR 7% to 8%, and if you exclude the Boston exit, is that kind of the right way to think
about sustainable TAVR growth kind of longer term?
Question: Travis Steed - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Great. That's helpful. And then since we were just at TCT a couple of days ago and you had a seven-year and 10-year data there,
maybe just talk about now that you've had a few days to talk to doctors kind of what you're hearing from customers and the physician
community and kind of the importance of that data and how it could or might not change practice.
Question: Travis Steed - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: That's really helpful. Thanks a lot and congrats on a good quarter.
Question: Larry Biegelsen - Wells Fargo Securities LLC - Analyst
: Good afternoon. Thanks for taking the question. And Scott, congratulations on all the success at Edwards, I know you'll be around
for a couple more quarters, but I enjoyed working with you and we'll miss working with you when you leave.
So for my question, Bernard, it sounds like you're comfortable with the 10% plus organic growth and 50 to 100 basis points margin
expansion next year. What's giving you the confidence this early and Scott, as of today, would FX positively or negatively impact
margins next year? And I had 1 follow-up.
Question: Larry Biegelsen - Wells Fargo Securities LLC - Analyst
: All right. Fair enough. And just for my follow-up, Bernard, as you approach the scheduled trial for the JenaValve deal, what's your
level of confidence you could overturn the FTC block? And just remind us of where SAPIEN X4 stands and when we'll see the pivotal
data. Thank you.
Question: Larry Biegelsen - Wells Fargo Securities LLC - Analyst
: Thank you.
Question: David Roman - Goldman Sachs - Analyst
: Thank you. Good afternoon, everyone, and Scott, I'll add my congratulations on moving on. I finally remember your first analyst
meeting in 2013, I think Edwards was a small-cap growth stock at $4 billion. So I think you're certainly leaving the company in a good
position, although we'll miss working with you.
Two questions for me. One, just starting on the TAVR side. When you look at the PREVUE-VALVE study that was presented at TCT
and think about the early TAVR study in context, can you maybe just help us look forward and I know we're all focused on like
indication expansion and asymptomatic patients.
But to what extent is there an opportunity here to see broader diagnostic rates for AS increase that would not only trickle through
to your TAVR business, but also be a tailwind to the surgical valve business as well?
Question: David Roman - Goldman Sachs - Analyst
: And maybe on the TMTT side, I think you said M3 approval coming in early 2026. Can you maybe help us think through how to
compare and contrast the M3 launch with EVOQUE? And I think Dr. Sharma at your analyst meeting on Monday kind of describe
tricuspid valves as they once forgotten valve, that's starting to gain attention from the clinical community with the now treatment
solutions that are out there. But I think mitral valve procedure volumes are low, is a much more mainstream and well-understood
disease states.
So help us think about how -- what are the factors influencing the M3 launch and whether using the EVOQUE launch is a good
template or not?
Question: Matt Taylor - Jefferies - Analyst
: Hi, thanks for taking the question. I wanted to circle back on TCT. You had a really nice showing kind of across the board. And I think
maybe stuff the most to us was how positive the real-world tricuspid data was. And you talked about having a toolbox there, and
you'll have that in mitral next year. So my question is really, after this tricuspid data and having the toolbox there.
Do you expect some acceleration in the tricuspid adoption could we also see that in mitral next year? Maybe you could just talk
about that in general and the pace of acceleration we might see.
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Great. Congrats on a good quarter. And Scott, wish you all the best, we'll miss working with you. Two quick ones for me. First one, I
know you've been working a lot in the past couple of years to try and improve efficiency in the cath lab, and you have some AI
initiatives and educational initiatives and just wondering how that's going, what you're doing exactly and how much efficiency and
extra capacity you've been able to help drive such good TAVR volumes?
Question: Robbie Marcus - JPMorgan Chase & Co - Analyst
: Maybe if I could just ask a quick follow-up for Scott on -- we had really good margin expansion. I think you've committed to 50 to
100 basis points, and I don't want to steal any thunder from the Analyst Day, but you're one of the biggest spenders in R&D at $1.1
billion, and it's clearly given you a great product pipeline and portfolio with a lot of big trials wrapping up, how do you think about
R&D and what's the right level of spend over the forward horizon? How are you thinking about that?
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