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Vaxcyte (PCVX) investor relations material
Vaxcyte Q3 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
VAX-31 met all prespecified primary endpoints in pivotal OPUS-1; safety was similar to PCV20 and PCV21 across age groups studied.
OPUS-1 results support a planned adult BLA submission in H1 2028, following OPUS-2/3 results expected in H1 2027 and a manufacturing consistency study.
September 30 cash, cash equivalents and investments totaled $2.264B; pro forma liquidity including October offering proceeds was ~$3.4B.
Financial highlights
Q3 R&D expense was $270.3M, up 28.8% YoY; G&A was $37.9M, up 17.0%, and operating loss was $308.3M.
Q3 net loss was $297.1M versus $212.8M YoY; diluted loss per share was $1.99 versus $1.56.
Nine-month net loss was $902.0M versus $520.1M; R&D expense rose 54.1% to $851.0M, primarily due to PCV manufacturing and Phase 3 trial costs.
Q3 other income, net fell 62.1% YoY to $11.2M, reflecting lower interest income and foreign-currency gains.
Outlook and guidance
OPUS-2 and OPUS-3 Phase 3 results are expected in H1 2027; both trials are fully enrolled and evaluate VAX-31 in adults aged 50 and older.
VAX-31 infant Phase 2 topline data are expected by the end of H1 2027; VAX-A1 adult Phase 1 topline data are expected in H2 2027.
Planned adult BLA submission is targeted for H1 2028, supported by OPUS-1, OPUS-2, OPUS-3 and a manufacturing consistency study.
R&D spending is expected to remain high as programs advance and manufacturing scales; G&A is expected to rise with headcount and support functions.
- VAX-31 met OPUS-1 immunogenicity endpoints, supporting a planned H1 2028 BLA.PCVX
Study result - OPUS-1 phase III data for VAX-31, promising broader coverage, will be released by end of October.PCVX
12th Annual Cantor Fitzgerald Global Healthcare Conference - VAX-31 aims for dominant market share with broader coverage and pivotal data expected by October.PCVX
Wells Fargo 21st Annual Healthcare Conference - Broad-spectrum vaccines VAX-31 and VAX-24 advance toward market with strong clinical and financial momentum.PCVX
Corporate presentation - VAX-31 and VAX-24 set new standards in pneumococcal vaccine coverage and immunogenicity.PCVX
Corporate presentation - Phase 3 trials fully enrolled; topline data expected Q4 2026; liquidity remains strong.PCVX
Q2 2026 - Upcoming infant phase II data may set a new standard for broad, potent pneumococcal protection.PCVX
TD Cowen 45th Annual Healthcare Conference - VAX-31's phase II success and broad coverage set the stage for market leadership and rapid growth.PCVX
2024 Cantor Fitzgerald Global Healthcare Conference - VAX-31 showed strong safety and broad immunogenicity, advancing to phase III for >95% coverage.PCVX
Study Result
Next Vaxcyte earnings date
Next Vaxcyte earnings date
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