Vaxcyte (PCVX) investor relations material

Strategic focus and pipeline overview

• Leveraging a proprietary cell-free protein synthesis platform to develop vaccines targeting bacterial infectious diseases, with a primary focus on pneumococcal disease in both adult and infant markets, projected to grow from $8B to $12–13B in 5–10 years.

• Preparing for commercial launch by hiring a Chief Commercial Officer and scaling manufacturing to meet anticipated demand.

• Advancing a pipeline beyond pneumococcal vaccines, including a newly initiated phase I study for Group A Strep, with data expected in the second half of next year.

Clinical development and regulatory expectations

• Three phase III adult studies (OPUS-1, OPUS-2, OPUS-3) have completed enrollment; top-line data from OPUS-1 expected in Q4 this year, with additional readouts in the first half of next year.

• Targeting BLA submission by end of 2027 and potential market entry in 2028.

• Phase II infant study for the 31-valent vaccine has completed enrollment, with top-line data expected by mid-next year.

• Regulatory success is defined by the totality of immunogenicity and disease coverage data, not just the number of non-inferiority misses; FDA guidance allows for a few misses if overall benefit is demonstrated.

Competitive landscape and market positioning

• Competitors have discontinued or deprioritized high-valency adult programs, enhancing the lead time for the 31-valent candidate.

• Recent epidemiological data show rising prevalence of serotypes not covered by competitors, strengthening differentiation.

• Broader serotype coverage historically drives market adoption, even without preferential recommendations from ACIP.

• Pfizer is developing a 35-valent vaccine but remains behind in clinical progress, providing additional runway for the 31-valent candidate.