8-KMaterial Agreements

REGENERON PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Jan 15, 2021)

Filed January 15, 2021For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. has entered into a significant supply agreement with the U.S. Government, specifically the Army Contracting Command, New Jersey, for its investigational dual antibody therapy, casirivimab and imdevimab. This agreement, effective January 12, 2021, is for the manufacture and supply of up to 1.25 million doses for the treatment of mild to moderate COVID-19 in high-risk, non-hospitalized patients, an indication currently under Emergency Use Authorization (EUA) by the FDA. The U.S. Government is committed to purchasing all filled and finished doses delivered by June 30, 2021, at a price of $2,100 per dose, potentially totaling up to $2.625 billion. The purchase price is tied to the lowest authorized dose at the time of delivery. While the agreement extends through January 12, 2022, the primary delivery obligation for these doses is within the first half of 2021. This agreement represents a substantial financial commitment and underscores the government's commitment to securing Regeneron's COVID-19 therapy.

Key Highlights

  • 1Regeneron signed a material definitive agreement with the U.S. Government for its COVID-19 antibody therapy (casirivimab and imdevimab).
  • 2The agreement mandates the manufacture and supply of up to 1.25 million filled and finished doses by June 30, 2021.
  • 3The U.S. Government will purchase these doses at $2,100 per dose, totaling a potential of $2.625 billion.
  • 4The therapy is authorized under an Emergency Use Authorization (EUA) for mild to moderate COVID-19 in high-risk, non-hospitalized patients.
  • 5The purchase price is contingent on the lowest FDA-authorized dose at the time of delivery.
  • 6The U.S. Government has the right to terminate the agreement for convenience, with provisions for termination costs for Regeneron.
  • 7The performance period extends to January 12, 2022, with key delivery obligations in the first half of 2021.

Frequently Asked Questions

The total potential value of the supply agreement is up to $2.625 billion, based on the purchase of up to 1.25 million doses at a price of $2,100 per dose.

The agreement involves Regeneron's novel investigational dual antibody therapy, casirivimab and imdevimab, which has received an Emergency Use Authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19 in high-risk, non-hospitalized patients.

Regeneron is obligated to manufacture and supply up to 1.25 million filled and finished doses by June 30, 2021. The U.S. Government may also accept doses between July 1, 2021, and September 30, 2021, at its discretion. The overall performance period for the agreement extends to January 12, 2022.

Key risks include the U.S. Government's right to terminate the agreement for convenience, manufacturing and supply chain considerations impacting the ability to deliver the required doses by the deadline, and the potential impact of authorized dose levels on the final price per dose.