Vaxcyte (PCVX) investor relations material

Key clinical and regulatory updates

• Phase III OPUS-1 study for VAX-31 in adults will read out by end of October, with tightened guidance from previous Q4 estimate.

• VAX-31 aims to provide broader pneumococcal coverage and improved immune responses compared to current 20- and 21-valent vaccines.

• Regulatory precedent suggests that non-inferiority misses are acceptable if overall benefit and coverage are superior.

• VAX-31 covers 95% of circulating disease, compared to 60% for PCV20 and 80% for PCV21.

• Comprehensive top-line data, including immunogenicity, safety, and tolerability, will be disclosed at readout.

Commercial strategy and market dynamics

• Adult pneumococcal vaccine market is rapidly growing, with retail pharmacies and large healthcare systems dominating distribution.

• Market share between PCV20 and CAPVAXIVE is currently about 50/50, with regional differences driven by serotype prevalence.

• Coverage breadth is the key driver for provider choice, and VAX-31 aims to resolve current trade-offs in vaccine selection.

• Commercial infrastructure is being built conservatively, with scaling planned post-data readout.

• ACIP is not currently operating, but other medical institutions have filled the guidance gap for vaccine recommendations.

Manufacturing and operational readiness

• Investments have been made in both small- and large-scale manufacturing facilities, with large-scale production already online.

• Manufacturing capacity and capital needs have been proactively managed to support potential launch.