Vaxcyte — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net loss for the three months ended September 30, 2026, was $297.1 million, compared to $212.8 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $902.0 million, compared to $520.1 million for the same period in 2025.
• Research and development expenses were $270.3 million for the three months ended September 30, 2026, up from $209.9 million in the same period in 2025.
• General and administrative expenses were $37.9 million for the three months ended September 30, 2026, up from $32.4 million in the same period in 2025.
• Cash, cash equivalents, and investments were $2,264.4 million as of September 30, 2026, compared to $2,442.6 million as of December 31, 2025.
• Pro forma cash, cash equivalents, and investments were approximately $3.4 billion as of September 30, 2026, including approximately $1.1 billion in net proceeds from October 2026 offerings.
• Weighted-average shares outstanding, basic and diluted, were 148.9 million for the three months ended September 30, 2026, compared to 136.2 million in the same period in 2025.
• Net loss per share, basic and diluted, was $(1.99) for the three months ended September 30, 2026, compared to $(1.56) in the same period in 2025.

Guidance and Future Outlook:

• The company expects to report results from the OPUS-2 and OPUS-3 Phase 3 trials for VAX-31 adult indication in the first half of 2027.
• Vaxcyte plans to submit a Biologics License Application (BLA) for VAX-31 adult indication in the first half of 2028.
• Topline safety, tolerability, and immunogenicity data for the VAX-31 infant indication Phase 2 study are expected by the end of the first half of 2027.
• Topline data from the VAX-A1 Phase 1 study in adults is anticipated in the second half of 2027.

Business Segments and Product Lines:

• VAX-31 Adult Indication: Positive topline data was announced from the OPUS-1 pivotal Phase 3 trial; the candidate met all prespecified primary endpoints and demonstrated a safety profile similar to PCV20 and PCV21.
• VAX-31 Adult Indication Trial Details: The OPUS-1 trial evaluated VAX-31 in 4,047 healthy, pneumococcal-naïve U.S. adults, including 3,572 aged 50 and older and 475 aged 18-49.
• VAX-31 Adult Indication Immunogenicity: VAX-31 met noninferiority criteria for all 28 shared serotypes with PCV20 and/or PCV21, all 11 shared serotypes with PCV20 and PCV21, nine serotypes unique to VAX-31 and PCV20, and eight serotypes unique to VAX-31 and PCV21.
• VAX-31 Adult Indication Superiority: Three serotypes unique to VAX-31 and cross-reactive serotype 20B met the superiority criterion.
• VAX-31 Adult Indication Immunobridging: VAX-31 met the noninferiority criterion for all 324 serotype OPA GMR comparisons in adults aged 18-49 compared to adults aged 50-64.
• VAX-31 Adult Indication Safety: No serious adverse events were considered related to study vaccines, and there were no study discontinuations due to adverse events.
• OPUS-2 and OPUS-3 Trials: OPUS-2 (1,390 participants) evaluates VAX-31 concomitant with or following influenza vaccine; OPUS-3 (752 participants) evaluates VAX-31 in previously vaccinated adults.
• VAX-A1: The Phase 1 study in adults is advancing to Stage 2 following DSMB review of Stage 1 data; the study will enroll approximately 80 healthy adults in Australia.
• VAX-24: Generated positive Phase 2 clinical results in both adults and infants; designed to cover more serotypes than any PCV on-market.
• VAX-XL: In earlier-stage development, leveraging carrier-sparing technology to expand coverage.
• VAX-GI: A vaccine candidate designed to prevent Shigella is in the pipeline.

Market and Competitive Landscape:

• VAX-31 is the broadest-spectrum PCV candidate in the clinic today.
• The company notes that serotypes unique to PCV21 account for a larger share of adult disease than those unique to PCV20, making the comparison of VAX-31 to PCV21 a particular focus of FDA review.
• Group A Strep remains a significant global cause of morbidity and mortality and a leading driver of antibiotic use.

Risks and Challenges:

• Forward-looking statements involve risks including potential delays or inability to obtain regulatory approvals, success and timing of clinical trials, and sufficiency of cash to support development programs.
• Risks include development timelines, success and timing of chemistry, manufacturing, and controls, and risks inherent with preclinical and clinical development processes.

Management Commentary and Tone:

• CEO Grant Pickering stated that OPUS-1 results represent a significant milestone and support VAX-31's potential best-in-class profile.
• CFO Andrew Guggenhime noted that the $1.1 billion in net proceeds strengthens the balance sheet and extends the cash runway to support commercial launch and other initiatives.
• Management expressed confidence in being well-positioned to support the potential U.S. commercial launch of VAX-31 for adults.

Other Key Points:

• Completed concurrent equity and convertible senior notes offerings in October 2026, generating $1.15 billion in gross proceeds and approximately $1.1 billion in net proceeds.
• The convertible senior notes bear interest at 1.50% per annum and mature in October 2032.
• Appointed Luis Jodar, Ph.D., as Chief Medical Officer and David McAvoy, J.D., as Chief Legal Officer in September 2026.
• Management will participate in fireside chats at the Guggenheim Healthcare Innovation Conference, UBS Global Biopharma Conference, Jefferies London Healthcare Conference, and Evercore Healthcare Conference in November and December 2026.
• The company utilizes XpressCF®, a cell-free protein synthesis platform exclusively licensed from Sutro Biopharma, Inc.