Vaxcyte, Inc. Q4 FY2022 earnings call

• 2022 was a landmark year for Vaxcyte with positive proof-of-concept clinical data for VAX-24, its lead pneumococcal conjugate vaccine. VAX-24 was granted Breakthrough Therapy designation for adults and on track for Phase 2 results in adults 65 and older in Q2. • Focused on advancing PCV franchise programs VAX-24 and VAX-31. VAX-31 expected to have adult IND submitted in H2 2023 and top-line data in 2024. • Launching first clinical program in infants for VAX-24 in Q2 2023. • Early-stage pipeline includes VAX-A1, VAX-PG, VAX-GI. • Strong financial position with over $950M on balance sheet as of Dec 31, 2022.

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

• Expect substantial increase in 2023 expenses, particularly in R&D, excluding the $23M Sutro charge. • VAX-24 Phase 3 non-inferiority study data expected in 2025. • VAX-31 adult IND submission in H2 2023 and top-line data in 2024. • VAX-24 infant Phase 2 study to begin in Q2 2023.

• Risks associated with forward-looking statements, including factors that could cause actual results to differ materially from forward-looking statements. • Uncertainties related to regulatory approvals, clinical trial outcomes, and market competition.

Q: Jason Gerberry asked about translatability of vaccine efficacy to pediatric population and ACIP panel discussion on Pfizer's PCV20.

A: Grant Pickering noted historical consistency in PCV formulation translatability, and ACIP discussion on PCV20 trade-off with 15-valent, and VAX-24's broader coverage and better immune responses.

Q: Roger Song asked about statistics for upcoming Phase 2 data and sample size for Phase 3.

A: Grant Pickering said historical Phase 3 studies in adult space need point estimates around 0.6, and Jim Wassil discussed superiority considerations.

Q: David Risinger asked about Phase 2 study comparator and lower bound for non-inferiority.

A: Grant Pickering said Phase 2 study starts vs PCV15, and Jim Wassil explained FDA's potential preference for comparing to broadest standard-of-care and lower bound considerations.

Q: Seamus Fernandez asked about VAX-31 IND timeline, manufacturing, and differentiation.

A: Grant Pickering said VAX-31 IND expected in H2 2023, leveraging Lonza infrastructure, and Jim Wassil discussed VAX-31's coverage and otitis media opportunity.

Q: Jonathan Miller asked about manufacturing expansion.

A: Andrew Guggenhime said evaluating options for manufacturing expansion, likely to be addressed in 12-18 months.

Q: Louise Chen asked about VAX31 vs VAX-24 and pipeline opportunities.

A: Grant Pickering said VAX-24 is primary focus, and pipeline programs like VAX-A1 have blockbuster potential.

Q: Joseph Stringer asked about first-to-market importance for VAX-24.

A: Grant Pickering said VAX-24 has a non-covalent bound approach advantage, and competitor program expected to launch later in the decade.