TAVR Growth Outlook
Q: Why has TAVR growth slowed, and what's the outlook?
A: TAVR growth came in below expectations due to capacity constraints at hospitals, as structural heart teams are taxed by new therapies and procedures. This cumulative effect has led to longer patient wait times and an increased number of emergent cases, which is not sustainable. Management believes this issue is temporary and expects hospitals to adapt and add capacity over time. They have adjusted TAVR growth guidance to 5% to 7% for the year. " " " "

Impact of New Therapies on Workflow
Q: Are new therapies like EVOQUE affecting TAVR volumes?
A: The introduction of new therapies, such as EVOQUE, is contributing to workflow challenges in hospitals. Starting new programs requires significant resources and often involves the same teams working on TAVR. While this initially impacts TAVR volumes, hospitals are expected to become more efficient over time, and management is confident the effect is temporary. " " "

EPS Guidance and Critical Care Spin-off
Q: Is EPS guidance changing due to Critical Care spin-off and acquisitions?
A: Management is not providing new EPS guidance at this time due to the pending spin-off of the Critical Care business, expected to close late in the third quarter. They indicated that the underlying growth rate is similar with or without Critical Care, maintaining an 8% to 10% sales growth guidance. They will provide full EPS guidance for 2025 at the December investor conference. " " "

Long-term TAVR Market Size
Q: Is the $10 billion TAVR market size forecast still valid?
A: While management remains confident in the long-term TAVR opportunity, they are not updating the 2028 market size guidance at this time. They plan to provide updated guidance at the December Investor Conference. "

Use of Proceeds from Critical Care Spin-off
Q: How will proceeds from the spin-off be used?
A: The first priority for capital remains investing in the company's growth, including capacity expansion and external investments. Management also considers share buybacks but emphasizes reinvestment in the business as the primary focus. "

Acquisition of Endotronix
Q: How does Endotronix fit into Edwards' business?
A: Edwards sees a significant opportunity in heart failure management with Endotronix's unique technology, which recently received broad FDA approval. This is viewed as a natural progression, aligning with Edwards' existing patient base treated with their valve technologies. Detailed strategy will be discussed after the acquisition closes in the third quarter. "

Competitive Dynamics in TAVR Market
Q: Is competition affecting U.S. TAVR volumes?
A: Management does not believe competitive dynamics are significantly impacting U.S. TAVR volumes. They acknowledge competitors' growth but suggest comparing growth rates in the context of different base sizes. "

EVOQUE Initial Rollout Feedback
Q: How is the EVOQUE launch progressing?
A: The initial rollout of EVOQUE in the U.S. and Europe has been positive, with strong physician demand and clinical outcomes aligning with trial results. This reinforces the need for both repair and replacement technologies to treat more patients effectively. "

Hospital Economics and Pricing Impact
Q: Do hospital economics affect prioritization and pricing decisions?
A: Management does not believe hospital economics are driving the current capacity constraints or affecting pricing decisions for TAVR or EVOQUE. The main issue is the bandwidth required to adopt new therapies, which is straining existing structural heart teams. "

TAVR Guidance Details
Q: What's included in the 5% to 7% TAVR growth guidance?
A: The guidance assumes similar market conditions in the second half, accounting for a slightly tougher fourth-quarter comparison. Early TAVR data expected at TCT in October is not anticipated to significantly impact fourth-quarter results. "