Vaxcyte (PCVX) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Market overview and growth drivers

• Global pneumococcal vaccine market is valued at $8 billion, with three-quarters from infants and one-quarter from adults; adult market growth is expected to accelerate.

• Four major players dominate: Pfizer, Merck, Sanofi, and GSK, with recent increased activity and competition.

• Recent ACIP decision lowered universal adult vaccination recommendation to age 50, expanding the eligible U.S. population by over 60 million adults.

• Catch-up vaccinations for adults aged 50–65 will drive a market surge over the next five to six years.

• Internationally, countries like Germany have begun recommending adult vaccination, with others considering similar moves.

Regulatory and clinical development updates

• FDA cleared the IND for VAX-31 in infants, accelerating phase II study initiation to January next year.

• VAX-31 received breakthrough therapy designation for adults, expediting phase III program planning.

• Phase III adult program to start mid-next year, with pivotal data expected in 2026 and BLA submission soon after.

• Phase III will include non-inferiority, lot-to-lot consistency, concomitant use, and at-risk population studies, targeting at least 3,000 subjects.

• Infant program phase II data will focus on the first co-primary endpoint after three doses, with booster data to follow later.

Technology and competitive positioning

• VAX-31 uses a cell-free, site-specific conjugation platform, enabling higher polysaccharide loading and improved immunogenicity.

• Achieves 96% coverage of circulating strains in the U.S., nearly doubling coverage compared to PCV20, with increased immunogenicity.

• Breadth of coverage and robust supply position VAX-31 for a preferential recommendation and dominant market share if first to market.

• Internationally, earlier adult vaccine introduction and broader serotype coverage may drive new recommendations and funding.

• Manufacturing investments at Lonza enable rapid scale-up for both adult and infant indications, reducing risk of supply delays.