TAVR Market Growth and Share Dynamics

Q: Travis Steed from Bank of America asked about the encouraging signs of procedure growth exiting Q3 and how much EARLY TAVR is playing into early referrals.

A: Bernard Zovighian stated that positive procedure signals at the end of the quarter give the company confidence that evidence and heightened focus are driving market growth, with modest year-over-year share gains also observed.

Q: Travis Steed from Bank of America asked a follow-up about the comment that future growth will be driven more by procedure volumes and less by share gains.

A: Daniel Lippis and Bernard Zovighian explained that the Boston Scientific exit in Europe has now fully annualized and sequential share gains have stabilized, meaning future growth relies on underlying market expansion rather than continued share capture.

Q: Larry Biegelsen from Wells Fargo asked if the expectation of less share gains signals a slowdown in TAVR growth next year and how to think about contributions from the NCD and PROGRESS.

A: Bernard Zovighian and Doretta Mistras clarified that they are not signaling a slowdown but rather confidence in achieving long-term mid- to high single-digit TAVR growth, with the NCD and other catalysts bringing a gradual and progressive impact over time.

PROGRESS Trial and Moderate AS Opportunity

Q: Robbie Marcus from JPMorgan asked about the timing of submission and expected approval for the moderate AS indication following the PROGRESS trial data.

A: Daniel Lippis noted that the indication is a high priority and stated that further updates on timing and its impact on 2027 and beyond will be provided at the upcoming investor conference.

Q: Matthew Taylor from Jefferies asked what is most misunderstood or underappreciated about the opportunity within moderate AS or the PROGRESS results.

A: Daniel Lippis explained that the key realization is understanding the difference between passive clinical surveillance and advanced surveillance needed to assess relative risk in moderate patients with at-risk features.

Q: Vijay Kumar from Evercore ISI asked how having the broadest label including moderate AS will change contracting and if Edwards will continue to gain share.

A: Bernard Zovighian and Daniel Lippis responded that while the broad label and SAPIEN platform performance are powerful, the main focus remains on driving market penetration and educating the clinical community rather than pushing aggressively for share gains.

Q: Vijay Kumar from Evercore ISI asked whether moderate AS expands the total addressable market or simply pulls forward patients due to disease progression.

A: Daniel Lippis stated that whether viewed as a moderate population one to two times bigger than the severe population or a severe population two to three times bigger than previously thought, the math results in a massive number of underserved patients with unmet clinical needs.

Guidance Philosophy and Regional Performance

Q: Robbie Marcus from JPMorgan asked about Doretta Mistras's guidance philosophy given the significant beat in Q3 and the implied sequential step down in Q4.

A: Theodora Mistras stated that the guidance approach remains grounded in principles of providing an appropriate, credible outlook anchored to the midpoint and reflecting underlying fundamentals.

Q: Pito Chickering from Deutsche Bank asked about European constant currency growth trends and whether Europe will settle into a high single-digit growth rate.

A: Daniel Lippis explained that comparisons should account for unusual summer seasonality patterns from the prior year and that the front half of the year was expected to be stronger due to those comps.

Q: Pito Chickering from Deutsche Bank asked for early physician feedback on TriClip versus PASCAL for tricuspid regurgitation and the impact of the new catheters in the Class II trial.

A: Daveen Chopra answered that physicians are very excited about the PASCAL tricuspid system, noting its differentiated features like elongation for complex anatomies and highlighting the positive randomized data from the Class II TR trial.