Edwards Lifesciences (EW) Investor update summary

TMTT and CLASP IITR

• Six-month primary endpoint met; win ratio 1.98 for PASCAL plus medical therapy vs medical therapy alone in severe or greater TR. Benefit was driven mainly by KCCQ and partly by tricuspid valve intervention.

• KCCQ improved substantially in 57% of treated patients, while 25% of control patients worsened; the modified intention-to-treat control group included 20 patients who crossed over.

• No significant difference in mortality or HF hospitalization at six months; one-year data showed ≤moderate TR in 80% with PASCAL vs 30% in control, with health-status gains evident by 30 days and sustained to one year.

• Endpoint timing shifted from two years to one year and then six months amid control-group attrition after competing device approvals and CMS coverage; participants will be followed annually through five years.

• Physicians highlighted earlier identification and intervention timing as key gaps; repair is preferred when anatomy can achieve mild-or-less TR, while replacement is used when repair is unlikely to deliver a good result.

TAVR and PROGRESS

• In moderate AS with at-risk features, TAVR reduced the two-year risk of death or HF events by 33% vs clinical surveillance; NNT was 14. Benefit was consistent across reported subgroups.

• HF hospitalization fell 52%; 30-day TAVR outcomes included 0% mortality and 0% disabling stroke. Pacemaker rates were 13% and 10% in the two groups.

• TAVR improved KCCQ by 15 points immediately; surveillance patients experienced health-status declines of up to 10–20 points before later TAVR.

• In the surveillance arm, 204 of 371 patients underwent AVR within two years; 27% had AVR by one year and 57% by two years. Among those receiving AVR, 81.4% had progressed to severe AS.

• ACTIVATE analyzed 54,000 moderate or severe AS patients from a 15-million-patient, 50-center dataset: 65% had moderate AS, and 80% of that group had at least one at-risk feature; at-risk moderate AS had ~2x mortality and HF hospitalization vs moderate AS without risk features.

Clinical and adoption implications

• Speakers called for active surveillance, comprehensive assessment and earlier valve-clinic referral; moderate AS progression was frequent and unpredictable, and more than 60% of PROGRESS control patients ultimately had delayed AVR.

• FDA collaborated on PROGRESS design; an updated CMS NCD allows reasonable-and-necessary TAVR applications to be considered with MACs. Indication and reimbursement timing remain uncertain; further discussion was expected at the December investor conference.

• Management characterized PROGRESS as a turning point in understanding and managing AS, and committed to continued innovation, evidence generation, clinician education and training.