EDWARDS LIFESCIENCES CORP earnings calls

TAVR and TMTT growth drivers

Q (Robert Marcus · JPMorgan): Analyst asked about drivers for strong TAVR results, whether share is shifting and how U.S. vs outside-U.S. growth compared. He also asked which TMTT products (PASCAL, EVOQUE, etc.) drove the upside.

A: Management said TAVR strength reflects many years of technology and evidence, and that SAPIEN is positioned as the benchmark platform. They said TAVR growth was similar in the U.S. and outside the U.S. For TMTT they said PASCAL, EVOQUE and early M3 all contributed to the quarter’s strength.

"And we believe that because of this, our results are durable." — Bernard Zovighian (CEO)

PROGRESS trial population details

Q (Larry Biegelsen · Wells Fargo): Analyst asked why management emphasized heterogeneity of the PROGRESS population and how a positive PROGRESS result would affect TAVR compared with prior new indications like asymptomatic.

A: Management said they split the PROGRESS presentation to show baseline characteristics in more detail, so physicians understand the disease and the study design. They highlighted that the moderate group is at least as large as the severe group and that the population is diverse and complex. Management invited a technical follow-up from Dan for more detail.

"So we went a little bit deeper into, hey, one is potentially the size and what we have presented at New York Valves is that moderate is at least as big as severe." — Bernard Zovighian (CEO)

Meaning of PROGRESS population

Q (Daniel Lippis): Analyst wanted more color on the PROGRESS population heterogeneity and what that means for interpreting results.

A: Management said PROGRESS is the first randomized trial in moderate AS with at-risk features and that the population is heterogeneous and not well understood. They noted the trial population looks representative of about 50% of the total moderate population and that age is similar to severe AS. Management added they expect minimal impact in 2026 and will provide more detailed 2027 guidance later.

10% company growth comment

Q (Larry Biegelsen · Wells Fargo): Analyst asked whether management believes the company can grow 10% underlying next year and what the drivers would be.

A: Management clarified the 10% comment referred to long-term company guidance, not specifically next year, and that TAVR is expected to grow mid- to high single digit. They said this was the same messaging given at the investor conference and on the Q1 call.

"Just to be clear, Larry, my comments on 10% is about the company." — Bernard Zovighian (CEO)

Q3 seasonality and NCD timing

Q (Travis Steed · BofA): Analyst asked what 'normalized seasonality in Q3' means and whether the math implying a down sequential TAVR in Q3 is correct. He also asked about the impact of the CMS NCD.

A: Management said they raised full-year guidance after a strong first half and that second-half growth may look artificially low because 2H 2025 comps were strong. For seasonality they said they do not expect a very strong summer like last year and expect some incremental dollars from Q2 to Q3. They deferred the detailed NCD discussion to Dan.

"So this year, we don't expect like last year to have a very strong summer basically." — Bernard Zovighian (CEO)

CMS NCD draft and effects

Q (Daniel Lippis · BofA): Analyst asked how important the CMS NCD is for TAVR growth, how many centers it might open, and whether it helps TMTT capacity.

A: Management said the NCD process is nearing completion with a final policy memo expected in September and they are encouraged by the draft. They highlighted three draft opportunities: a pathway for asymptomatic coverage, recognition that symptomatic severe AS can be covered without evidence development, and modernization empowering heart teams. They said the draft still requires cardiac surgery programs for coverage, so center expansion is possible but the bigger impact will be improving program efficiency and patient flow.

PROGRESS adoption path

Q (Joanne Wuensch · Citibank): Analyst asked, assuming positive PROGRESS data, how quickly adoption might occur and the steps to convert that to revenue.

A: Management did not answer directly in this exchange and instead passed the question to Dan for a detailed response. They deferred to the next speaker to address adoption and commercialization steps.

"I'm going to let Dan take this one." — Bernard Zovighian (CEO)

How PROGRESS could be adopted

Q (Daniel Lippis · Citibank): Analyst asked how to think about adoption and the steps needed for PROGRESS to contribute to revenue if results look good.

A: Management said they must first see the results at TCT and that adoption of a new indication is like the asymptomatic case: it requires change management, education and behavior change. They emphasized these indications lack a prior predicate, so uptake will involve physician learning and will differ from trials that compared to an existing surgical option.

PASCAL tricuspid approval and positioning

Q (Pito Chickering · Deutsche Bank): Analyst asked if PASCAL tricuspid trial was successful and submitted to the FDA, and how Edwards is positioned to enter tricuspid versus mitral.

A: Management said they expect the data to be presented at TCT and are planning for a U.S. approval in Q4. They noted PASCAL's differentiated features are even more useful in tricuspid cases based on European experience, and they expect PASCAL tricuspid to add a fourth layer of growth for TMTT, supporting the $2 billion 2030 goal.

"I think we'll all look at the data together, and our expectation is for a Q4 approval in the U.S. is our current planning right now." — Daveen Chopra

EVOQUE vs broad TMTT growth

Q (Vijay Kumar · Evercore): Analyst asked whether EVOQUE showed an inflection and was driving TMTT strength, or whether the strength was broad across the TMTT portfolio.

A: Management said growth is coming across all TMTT platforms and regions. They said PASCAL is largest by revenue, EVOQUE is second and growing quickly with new centers and process improvements, and M3 is the newest with high growth but still small by size.

"As Bernard mentioned upfront in the call to Rob's question, we've seen a growth coming across all of the platforms in TMTT, and to be honest, all the regions for TMTT." — Daveen Chopra

PROGRESS baseline drugs question

Q (Daniel Lippis · Evercore): Analyst asked whether baseline drug treatments were considered or randomized in PROGRESS and whether drug arms differed between groups.

A: Management said PROGRESS is not a heart failure trial but a trial of moderate AS patients with at-risk features, and that many patients did have symptoms yet had healthy left ventricular function. They said drug regimens were not a major factor because these patients do not have heart failure symptoms, and more detail will come at TCT.

TAVR-in-TAVR opportunity

Q (Joshua Jennings · TD Cowen): Analyst asked for Edwards' internal expectations for the TAVR-in-TAVR market opportunity and when those procedures might meaningfully add to volume.

A: Management said lifetime management and redo procedures are factored into their market model today but currently represent a relatively small part of the market. They expect that to grow over time as more patients outlive valve durability, and they reiterated overall confidence in multiple TAVR and TMTT catalysts that underpin long-term company targets.

"Right now, it represents a relatively small part of the market relatively." — Daniel Lippis