Vaxcyte, Inc. Q4 FY2024 earnings call

• Vaccines are critical in public health, especially for bacterial infections. Vaxcyte is advancing a pipeline including pneumococcal conjugate vaccines (PCVs) and other broad-spectrum vaccines to address unmet needs. • 2024 was a defining year with progress in PCV franchise clinical trials: VAX-31 in adults showed strong Phase 1/2 results, leading to Phase 3 advancement; VAX-24 in infants was fully enrolled with data expected soon. • Manufacturing scale-up with Lonza: A dedicated facility to support PCV programs is on track to complete by early next year. • Financial strength: $3.13 billion in cash, cash equivalents, and investments as of December 31, 2024, from successful equity offerings.

No detailed product segment financial performance with absolute terms and revenue contribution % provided in the transcript.

• Expect substantial increase in R&D and G&A expenses in 2025, particularly in R&D, driven by manufacturing investments, initiation of VAX-31 adult Phase 3 program, and team growth. • Cash runway: Sufficient to fund key milestones like VAX-24 data readouts, VAX-31 Phase 3 studies, and completion of the dedicated manufacturing suite at Lonza.

• Forward-looking statements are subject to various risks, uncertainties, and factors that could cause actual results to differ materially from forward-looking statements. Risks are discussed in the company's press release and SEC filings, including risk factors in Form 10-K.

Q: Regarding the Phase 2 VAX-24 infant primary series data readout, can you provide color on the timing and safety data?

A: The top-line data will focus on IgG antibody responses for the primary immunization series. Safety data will include post-primary through boost, with most safety data included by the end of the quarter.

Q: How should we think about the non-inferiority criteria for VAX-24 given the smaller Phase 2 sample size?

A: Per precedent, a 15 percentage point differential is considered due to the smaller sample size in Phase 2. Expecting better outcomes than the 20-Valent vaccine, with confidence in higher immune responses translating from adults to infants.

Q: Can you provide granularity on macro discussions with DC regarding PCVs?

A: There is bipartisan support for vaccines, and the company is actively engaged. However, noise and speculation in the market need caution, with focus on the ultimate actions and broad understanding of vaccines' importance.

Q: What is the timeline for the Phase 3 program of VAX-31 in adults?

A: VAX-31 is expected to initiate the pivotal non-inferiority Phase 3 study by mid-2025, with top-line safety, tolerability, and immunogenicity data expected in 2026.

Q: Explain Vaxcyte's technology for the Group A Strep vaccine and its progress?

A: Leverages site-specific conjugation of polysaccharides unique to Group A Strep to a conserved protein. Progress includes analytical method development and process scale-up, with the program advancing toward the clinic.

Q: Discuss the non-inferiority margin and seroconversion for VAX-24?

A: A 10% delta is the registration hurdle, but a 15 percentage point differential is considered for Phase 2 due to sample size. Expecting better seroconversion than the 20-Valent vaccine, with higher immune responses observed in adults translating to infants.

Q: How does the VAX-24 infant data impact the outlook for VAX-31?

A: VAX-24 data triangulates confidence for VAX-31, using the infant data as a bellwether for VAX-31's potential outcomes. Doses can be tweaked based on Phase 2 results for Phase 3 dose selection.

Q: What are the hurdles for changes to the PCV routine child vaccination schedule by RFK?

A: Unlikely to change, as the health and economic benefits of PCVs are clear, and there is no impetus to reduce vaccination schedules given the persistent threat of pneumococcal disease.

Q: What is the likelihood of ACIP not granting a preferred recommendation for VAX-24 or VAX-31?

A: Confident in a compelling profile, but not guaranteed. Based on vaccine merits relative to standard-of-care, expecting a preferred recommendation given the improved coverage and immune responses over existing vaccines.