Replies to post #252379 on Biotech Values

[DewDiligence]

The first patients eligible for revaccination won’t happen until the 2025-2026 season so there was no urgency here. I’m still assuming annual for MRNA amd biennial for GSK/PFE.

I concur. If MRNA’s mResvia had been approved in time for the 2023-2024 RSV season, ACIP probably would have had to address the re-vaccination schedule at today’s meeting. However, mResvia FDA approval only one month ago allowed ACIP to kick the can down the road.

[DewDiligence]

MRNA—(-21%)—reports 2Q24 results—cuts 2024 sales guidance:

https://finance.yahoo.com/news/moderna-reports-second-quarter-2024-103000708.html

The Company revises its 2024 expected net product sales to $3.0 to $3.5 billion from its respiratory franchise. …The update in product sales is driven by three primary factors: very low EU sales in 2024, potential revenue deferrals for certain international sales into 2025, and an increasingly competitive environment for respiratory vaccines in the U.S.

The 2024 sales guidance given three months ago was $4B, so the new guidance is a reduction of $500M-$1.0B.

The third reason for the guidance cut cited above — “an increasingly competitive environment for respiratory vaccines in the U.S.” — is not well stated. The competition per se for respiratory vaccines in the US has not increased (the three players in RSV vaccines remain GSK, PFE, and MRNA); however, the CDC reduced the addressable US market for RSV vaccines by omitting adults age 60-74 without increased risk factors for severe disease, while also postponing any recommendation about booster shots (https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-06-26-28/12-RSV-Adult-Melgar-508.pdf ).

The first two reasons cited above for the guidance cut — “very low EU sales in 2024” and “potential revenue deferrals for certain international sales into 2025” are essentially the same issue: PFE/BNTX have locked up most of the European market for COVID vaccines in 2024-2025.