Edwards Lifesciences (EW) BofA Securities 2025 Healthcare Conference summary

Financial performance and guidance

• Reported strong Q4 and Q1 results, maintaining 2025 top-line guidance of 8-10% growth and EPS of $2.40-$2.50, despite dilution from JenaValve and tariff costs.

• Committed to double-digit top-line growth starting in 2026, with EPS growth outpacing revenue.

• Tariff impacts are minimal due to diversified supply chain and limited China exposure; main exposures are from Singapore and Costa Rica, with a projected $0.05 EPS impact in 2025.

• Flexible P&L management and prioritization of investments allow for offsetting dilution and maintaining growth targets.

• Investments in R&D and supply chain have built resilience, supporting ongoing financial strength.

Growth catalysts and innovation

• Early TAVR approval and strong clinical data present multi-year growth opportunities, with NCD and guideline changes expected to further expand the market.

• CE mark for transcatheter mitral replacement in Europe and 8-year Resilia data highlight innovation leadership.

• Emerging opportunities include AR with JZ Medical and heart failure technologies from Endotronix acquisition, both progressing in pivotal studies.

• TMTT business is accelerating, with Pascal and Evoque driving growth; on track for $500M in revenue this year, targeting $2B by 2030.

• M3 approval expected in the US next year, unlocking further mitral valve opportunities.

Regulatory and market access developments

• FDA approval for asymptomatic TAVR is a pivotal milestone; comprehensive physician education and guideline updates are underway.

• NCD for Evoque finalized, creating and leading a new category; high demand from TAVR centers, with training capacity as the main bottleneck.

• CMS likely to reopen TAVR NCD soon, with policy and guideline changes expected in the next 12-18 months, supporting multi-year growth.

• Moderate TAVR data expected at TCT 2026, representing a significant potential opportunity depending on study results.