Edwards Lifesciences (EW) investor relations material

Strategic vision and leadership

• Focus remains on structural heart disease, with five key therapy areas driving growth: TAVR AS, PASCAL, EVOQUE, SAPIEN M3, and surgical.

• Leadership emphasizes strategic clarity, flawless execution, and a mission-driven culture among 17,000 employees.

• Recent leadership changes include a new CFO, supporting acceleration of the current strategy.

• Divestiture of non-core business has increased agility and strategic focus.

• Long-term goal is to sustain top-tier performance and target approximately 10% annual top-line growth.

Regulatory and market access developments

• Recent CMS NCD changes provide greater flexibility for patient access and treatment, reducing procedural requirements and enabling more centers to offer TAVR.

• NCD now allows single-operator procedures and remote evaluations, streamlining patient pathways.

• Removal of minimum volume requirements for TAVR centers could enable 100–200 new centers over time, expanding access.

• Asymptomatic patients are now covered, and a pathway exists for future FDA approvals and new indications.

• These regulatory changes are expected to drive multi-year growth and increase capacity, especially for simpler cases.

Innovation, clinical trials, and product pipeline

• SAPIEN platform highlighted for best-in-class performance, low complication rates, and benchmark durability at seven years.

• The PROGRESS trial, with results expected soon, could expand the addressable market to moderate and asymptomatic patients.

• TMTT segment targets $2 billion revenue by 2030, driven by PASCAL, EVOQUE, and SAPIEN M3, with potential for much higher long-term growth.

• PASCAL is the most established, EVOQUE is creating a new category, and SAPIEN M3 is in early stages but showing high demand.

• Ongoing innovation and clinical evidence are expected to further expand indications and market penetration.