Edwards Lifesciences (EW) Q4 FY25 earnings call: guidance and Q&A

Asked about the drivers of strong TAVR growth, potential share gains beyond Boston Scientific's exit, and the contribution of volumes versus price.

Management attributed strong TAVR growth to compelling clinical evidence (EARLY TAVR, PARTNER III/II long-term data) driving increased physician confidence and urgency in treating severe AS. They noted share gains from Boston Scientific's exit were in line with their competitive position, and strong adoption of SAPIEN 3 Ultra RESILIA also contributed to performance, including pricing.

“this is creating the physicians to talk more about TAVR, to talk more about SAPIEN. This is enabling a physician to treat their patients a little bit early. This is also enabling providers to prioritize TAVR.”

asked by Robert Marcus · answered by Bernard Zovighian

Inquired about the significant increase in Q4 SG&A spending, its allocation, and whether it represents a one-time cost.

The increased SG&A was a planned, aggressive step-up to fund strategic investments in patient access, including EARLY TAVR education, field force reinforcement, and the AHA partnership. Some spending was delayed from earlier in 2025. They expect more moderated operating expense growth in 2026, contributing to operating margin expansion.

“We invested more aggressively in patient access. So asymptomatic amplification. Bernard mentioned the American Heart Association partnership. We've also been reinforcing our field force in THV and also in TMTT.”

asked by Robert Marcus · answered by Scott Ullem

Asked about the potential impact of the TAVR NCD reconsideration on growth, centers, and patient pathways, and how the debate on the care team might shape the final outcome.

The NCD process was formally reopened, with an initial draft expected around June and final determination in Q4. Impact for 2026 is negligible, but significant for 2027 and beyond. The focus is on ensuring timely and equitable access to care, with a big win being coverage to label and changes reducing procedural complexity. Most public commentary has been positive.

“So if you think about impact for 2026, negligible, but probably important and more relevant in 2027 and beyond. Now the key priority areas for us is to ensure timely and equitable access to care for patients, right?”

asked by Travis Steed · answered by Daniel Lippis

Asked about the size of the LAAC market, how Edwards' offering will be differentiated, and the expected sales ramp.

Edwards sees LAAC as a new therapeutic area with significant unmet patient needs where they can bring differentiated technology. They believe it's a complementary solution to existing valvular procedures. They expect a measured commercial rollout and see it as a future growth driver for Surgical, but did not quantify market size or sales ramp.

“We think there's still unmet patient needs. And that's where we believe, obviously, that we can come out with the technology in this new therapeutic area for Edwards Surgical, we can come out with a solution that can really help patient care.”

asked by Larry Biegelsen · answered by Daveen Chopra

Asked for more detail on the implications of lifetime management for TAVR, specifically for valve and vendor selection, and its contribution to market share gains.

Management emphasized that with modern medicine, patients often outlive their first valve, making lifetime management crucial. Getting the first procedure right ensures future options (valve-in-valve, coronary access). They believe their platform is uniquely positioned for both acute and lifetime management, which will be a key value proposition for immediate and future share gains. This applies to both younger and elderly patients.

“So this lifetime management thing, getting the first procedure right upfront is a big thing. It is a conversation that everybody is focused on in the clinical community.”

asked by David Roman · answered by Daniel Lippis

Asked about the uptake of SAPIEN M3 in the US and Europe, and further color on European guideline changes and their impact.

SAPIEN M3 is scaling in line with expectations in both the US and Europe, with high procedural success and positive patient outcomes, particularly for those without other surgical options. European TAVR guidelines reduced the age recommendation from 75 to 70 and recommend proactive disease management, shifting away from watchful waiting. This is seen as a significant, but gradual, momentum driver for durable growth.

“The European guidelines with FMR, they're now Class I for functional mitral regurgitation for reduction of heart failure hospitalizations. So we're seeing, I think, increased awareness, specifically in mitral and tricuspid, increased awareness for these 2 diseases and increased kind of referrals happening with this guideline shift.”

asked by Joanne Wuensch · answered by Daveen Chopra

Asked for clarification on the specific drivers of increased US TAVR growth in recent quarters, beyond Boston Scientific's exit, including the contribution of EARLY TAVR.

The strong US TAVR growth is primarily driven by compelling clinical and economic data from EARLY TAVR, PARTNER III/II, which has increased confidence and urgency in treating symptomatic AS. This leads to prioritizing TAVR patients and earlier treatment. While asymptomatic patients aren't yet showing up in claims data due to NCD limitations, there's an increase in echoes, referrals, and stress tests. SAPIEN 3 Ultra RESILIA adoption is also a meaningful contributor.

“So this is regardless of whether the patient is asymptomatic or not. This is the impact that it is having on symptomatic aortic stenosis is what we see largely driving our growth.”

asked by Matthew Taylor · answered by Daniel Lippis

Asked about the right way to think about moderate AS patients, their similarity to low-risk or asymptomatic TAVR patients, and the mortality rate for untreated moderate AS.

Management expressed confidence in the potential benefit of SAPIEN 3 for moderate AS patients, noting it's a large population. They emphasized waiting for the PROGRESS trial results at TCT before discussing specifics, adhering to a high bar for clinical evidence. They clarified that PROGRESS is not an asymptomatic trial but focuses on symptomatic moderate AS, and that the disease progression can be unpredictable.

“PROGRESS is not a symptomatic moderate, right? So we're talking about a symptomatic patient population. And we don't know the results of the trial. We don't know what it looks like.”

asked by Vijay Kumar · answered by Daniel Lippis