Edwards Lifesciences (EW) investor relations material

Business evolution and clinical milestones

• Significant momentum in 2025 driven by EARLY TAVR clinical trial data and seven-year durability results for SAPIEN valves, reinforcing physician confidence and spurring growth.

• Introduction of both repair and replacement solutions for mitral and tricuspid regurgitation, positioning the company as a partner in therapy selection.

• Expansion of the surgical portfolio, including the INSPIRIS aortic replacement valve and plans for a left atrial appendage closure solution.

• Hospital capacity constraints seen in 2024 have largely resolved, supporting increased patient treatment rates.

TAVR business outlook and growth drivers

• U.S. TAVR growth accelerated in the second half of 2025, fueled by new clinical data and increased urgency in treating severe aortic stenosis.

• 2026 TAVR growth guidance set at 6%-8%, supported by a global footprint of 2,000 sites and over 60 countries.

• Confidence in guidance has increased since the initial investor conference, with further updates expected at Q1 2026 earnings.

• Upcoming U.S. NCD draft and guideline updates are key focus areas for 2026, following recent changes in Europe.

• Market share dynamics remain uncertain pending new competitor data and evolving physician practices.

TMTT (transcatheter mitral and tricuspid therapies) developments

• Comprehensive portfolio now includes PASCAL (repair), EVOQUE (tricuspid replacement), and SAPIEN M3 (mitral replacement), enabling tailored patient care.

• PASCAL remains the largest revenue contributor, with EVOQUE growing faster due to later market entry; SAPIEN M3 is in early stages with positive feedback.

• Focus is on expanding treatment rates for mitral and tricuspid regurgitation, which lag behind aortic stenosis.

• Key upcoming clinical readouts include CLASP II TR for PASCAL and TRISCEND II for EVOQUE, expected to inform future growth.

• Next-generation EVOQUE and PASCAL devices are planned for launch in late 2026, continuing the innovation cycle.