Pfizer amends U.S. government Paxlovid supply agreement

Pfizer announced that it has amended its supply agreement with the U.S. government for Paxlovid, the first oral antiviral pill approved by the U.S. Food and Drug Administration. At the end of 2023, Pfizer will accept a non-cash return of any remaining Emergency Use Authorized (EUA)-labeled U.S. government inventory, estimated to be 7.9 million treatment courses, and in the fourth quarter, will reverse the associated revenues currently estimated to be approximately $4.2 billion. The commercial transition will begin in November 2023, as the U.S. government begins to discontinue the distribution of EUA-labeled Paxlovid. Pfizer will ensure commercial readiness by providing NDA-labeled commercial supply to all channels by the end of 2023, however, EUA-labeled Paxlovid will remain available free-of-charge to all eligible patients until the end of the year, and therefore Pfizer expects only minimal uptake of NDA-labeled commercial product before January 1, 2024. Any remaining EUA-labeled treatment courses previously purchased by the U.S. government will be converted to a volume-based credit. This credit will support continued access to Paxlovid through a patient assistance program (PAP) operated by Pfizer on behalf of the U.S. government. As part of the PAP, all federally insured patients (Medicare and Medicaid) and the uninsured will receive Paxlovid, free of charge, through 2024. Beginning in 2024, Pfizer will sell Paxlovid to privately insured patients (commercial) with prices to be negotiated with payers and offer a copay program through 2028. The PAP will continue to provide access to Paxlovid to eligible uninsured and underinsured patients through that same period. Additionally, Pfizer will manage and supply 1.0 million treatment course U.S. Strategic National Stockpile (SNS) to enable future pandemic preparedness and refresh stock prior to expiry through 2028. Pfizer will recognize revenues as product is delivered beginning in 2024.