Jessica Five

Jessica Five (JPMorgan Chase & Co.) inquired about the U.S. COVID vaccine manufacturing and demand relative to projections, the performance of the ex-U.S. season, and the potential annual revenue contribution from the manufacturing sites in the U.K., Canada, and Australia.

Answer

CFO Jamey Mock stated that U.S. vaccination rates are tracking within the anticipated 20-40% decline, leading to a narrowed U.S. revenue guidance. For ex-U.S. markets, the bottom end of revenue guidance was raised due to contracted volumes and increased visibility. He confirmed Canada's manufacturing is operational, Australia is expected to contribute revenue in Q4 2025, and the U.K. in Q1 2026, anticipating revenue growth from these strategic partnerships next year.

Jessica Five asked about the U.S. COVID vaccine manufacturing and demand relative to projections, the ex-U.S. season performance, and the potential annual revenue contribution tied to the manufacturing sites in the U.K., Canada, and Australia.

Answer

Jamey Mock, Chief Financial Officer, stated that the revised U.S. guidance of $1.0 billion-$1.3 billion reflects anticipated vaccination rates being down 20%-40%, which is within the company's initial expectations. For ex-U.S. markets, the revenue guidance was raised to $600 million-$700 million due to increased visibility on contracted volumes. He confirmed Canada's facility is operational and contributing revenue, Australia is expected to contribute in Q4 2025, and the U.K. in Q1 2026, with U.K. revenue for 2025 having shifted to 2026.

An analyst on behalf of Jessica Fife of JPMorgan Chase & Co. asked about the company's comfort level with current consensus sales estimates for the upcoming paltusotine launch.

Answer

CFO Tobin Schilke stated that it is not typical or prudent for the company to comment on consensus estimates at this stage, as they have not provided official guidance. He reiterated confidence in the launch preparations and the progress being made with the FDA.