Edwards Lifesciences Corp Q1 FY2025 earnings call

• TAVR: Growth driven by SAPIEN technology, early TAVR trial data highlighting urgency for severe AS treatment, expectation of asymptomatic indication approval in Q2, and efforts to expand access.
• TMTT: Strong momentum with differentiated portfolio, recent approval of SAPIEN M3 in Europe, progress with Evoque, and raised sales guidance.
• Surgical: Positive procedure growth, high-quality evidence on Resilia Tissue technology, Mitris launch in China, and progress on Connect aortic valve conduit.
• Innovation: Achievements include SAPIEN M3 approval in Europe, Evoque NCD, and long-term TAVR trial results.

TAVR: First quarter global sales were $1.05 billion, up 5.4% year-over-year (6.5% constant currency). Maintained full-year sales growth guidance of 5% to 7%. TMTT: First-quarter sales were $150 million, a growth of about 60%. Raised 2025 TMTT sales guidance range to $530 to $550 million. Surgical: First-quarter global sales were $251 million, up 3% year-over-year.

• Total company sales growth guidance for 2025 is 8% to 10%.
• Raised 2025 TMTT sales guidance to $530 to $550 million.
• Second-quarter sales projected at $1.45 to $1.53 billion, adjusted EPS at $0.59 to $0.65.
• EPS guidance remains $2.40 to $2.50, with plans to offset tariffs and Yenovale impact.

• Impact of tariffs that could materially affect future financial results.
• Uncertainties around Yenovale acquisition integration and timing.

Q: Congrats on a good start to the year. How do tariffs and Yenovale impact EPS?

A: Tariffs impact is about $0.05 to EPS, Yenovale impact is $0.05 to $0.10, with hedging and plans to offset.

Q: How does the NCD for Evoque impact its ramp?

A: NCD ensures Medicare access, aligns with expectations and supports Evoque's 2025 ramp.

Q: On TAVR, what about referral patterns post early TAVR trial?

A: Expect FDA approval in Q2, then detailed education plan to amplify referral message.

Q: On TMTT, market segmentation for repair vs replacement?

A: Repair and replacement technologies are additive, with Evoque and M3 expanding treatment options.

Q: On TAVR capacity constraints, any updates?

A: Working with hospitals on training and capacity, expecting policy and guideline changes to help.

Q: On EPS guidance offsets, how precise is the offset?

A: Premature to be more precise, depends on Yenovale close timing and integration.

Q: On Japan trends, any updates?

A: Japan has weaker procedure growth and competition, but long-term potential due to aging population.

Q: On M3 launch, how does it compare to Evoque?

A: M3 launch is gradual, with different indication dynamics than Evoque.

Q: On NCD timing and impact, any updates?

A: CMS controls NCD timing, expects policy to reflect TAVR safety and expand access.

Q: On Evoque training demand, how is it going?

A: High demand, growing number of trained sites with strong patient outcome feedback.

Q: On surgical segment growth, any confidence?

A: Confident in mid-single-digit growth with new launches and evidence.

Q: On Pascal utilization, where are we?

A: Pascal has feature differentiation, spreading in new and existing centers with room for growth.

Q: On FDA approval timelines, any impact?

A: No current impact seen, FDA professionals are committed, but monitor fluid situation.