Item 1.01. Entry into a Material Definitive Agreement.
On January 12, 2021, Regeneron Pharmaceuticals, Inc. ("Regeneron" or the
"Company") entered into a supply agreement (the "Supply Agreement") with the
Army Contracting Command, New Jersey, an entity acting on behalf of the U.S.
Department of Defense and the U.S. Department of Health and Human Services
(collectively, the "U.S. Government"), to manufacture and supply to the U.S.
Government casirivimab and imdevimab, the Company's novel investigational dual
antibody therapy that has received an Emergency Use Authorization ("EUA") from
the U.S. Food and Drug Administration (the "FDA") for the treatment of mild to
moderate COVID-19 in high-risk non-hospitalized patients (the "EUA Indication").
Pursuant to the Supply Agreement, the U.S. Government is obligated to purchase
all filled and finished doses of drug product delivered by June 30, 2021, up to
1.25 million doses total, and may accept doses during the period from July 1,
2021 through September 30, 2021 at its discretion. The U.S. Government will
acquire doses at the lowest dose authorized or approved by the FDA for the EUA
Indication prior to or on the date of delivery for a price of $2,100 per dose,
resulting in payments to Regeneron of up to $2.625 billion in the aggregate.
Under the EUA, the current authorized dose for the EUA Indication is 2,400 mg;
and Regeneron is evaluating the safety and efficacy of a lower 1,200 mg dose. A
number of factors may impact available filled and finished supply by June 30,
2021, including manufacturing considerations and authorized dose levels. The
Company is also obligated to distribute the filled and finished drug product to
patient care sites as directed by the U.S. Government.
The Supply Agreement contains terms and conditions that are customary for U.S.
Government agreements of this nature, including provisions giving the U.S.
Government the right to terminate the Supply Agreement for convenience. If the
Supply Agreement is terminated for convenience prior to completion, Regeneron is
entitled to be paid certain termination costs, including the percentage of the
contract price reflecting the percentage of work performed plus certain
reasonable charges resulting from termination. The performance period under the
Supply Agreement extends from January 12, 2021 through January 12, 2022, except
as noted above with respect to the delivery of filled and finished doses.
The foregoing description of the Supply Agreement is qualified in its entirety
by reference to the full text of the Supply Agreement, a copy of which will be
filed with the U.S. Securities and Exchange Commission as an exhibit to the
Company's Quarterly Report on Form 10-Q for the quarterly period ending
March 31, 2021.
Note Regarding Forward-Looking Statements
This Current Report on Form 8-K (this "Report") includes forward-looking
statements that involve risks and uncertainties relating to future events and
the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the
"Company"), and actual events or results may differ materially from these
forward-looking statements. Words such as "anticipate," "expect," "intend,"
"plan," "believe," "seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking statements, although
not all forward-looking statements contain these identifying words. These
statements concern, and these risks and uncertainties include, among others, the
ability of Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and product
candidates (including the casirivimab and imdevimab antibody cocktail) and the
impact of the foregoing on Regeneron's ability to supply its products and
product candidates, including its ability to supply doses of the casirivimab and
imdevimab antibody cocktail under the terms of the supply agreement with the
U.S. government discussed in this Report (the "Supply Agreement"); whether and
to what extent Regeneron will be able to supply doses of the casirivimab and
imdevimab antibody cocktail under the Supply Agreement; the amount of payments
(if any) Regeneron may receive pursuant to the Supply Agreement; what the lowest
authorized dose of the casirivimab and imdevimab antibody cocktail will be at
the time of delivery to the U.S. government under the Supply Agreement; and
whether the Supply Agreement is terminated by the U.S. government or otherwise
prior to completion. A more complete description of these and other material
risks can be found in Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2019 and its
Form 10-Q for the quarterly period ended September 30, 2020. Any forward-looking
statements are made based on management's current beliefs and judgment, and the
reader is cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update (publicly or
otherwise) any forward-looking statement, including without limitation any
financial projection or guidance, whether as a result of new information, future
events, or otherwise.
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