Vaxcyte (PCVX) Q3 2026 earnings summary

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.