Item 2.02. Results of Operations and Financial Condition.
On January 11, 2021, at the virtual 39th Annual J.P. Morgan Healthcare
Conference, Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive
Officer of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and
George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of
Regeneron, are providing a corporate update.
The presentation includes information regarding the Company's preliminary
(unaudited) U.S. net product sales of EYLEA® (aflibercept) Injection of
approximately $4.95 billion for the full year 2020 (based on preliminary
(unaudited) fourth quarter 2020 U.S. net product sales of EYLEA of approximately
$1.34 billion). Overall distributor inventory levels for EYLEA in the United
States remained within the Company's one-to-two-week targeted range.
The presentation also includes information regarding the Company's preliminary
(unaudited) U.S. net product sales of casirivimab and imdevimab, the Company's
novel investigational dual-antibody therapy for COVID-19, of approximately $184
million for the full year 2020 (based on preliminary (unaudited) fourth quarter
2020 U.S. net product sales of casirivimab and imdevimab of approximately $144
million). The Company expects that the full 300,000 doses under the previously
announced contract with the U.S. government will be fulfilled by the end of
February 2021.
Item 7.01. Regulation FD Disclosure.
The information set forth under Item 2.02 of this Current Report on Form 8-K is
incorporated by reference herein. A copy of the presentation referenced in Item
2.02 is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is
incorporated by reference in this Item 7.01.
The information included in Item 2.02 and the information included or
incorporated in Item 7.01 of this Current Report on Form 8-K, including Exhibit
99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, nor shall such information and exhibit be
deemed incorporated by reference in any filing under the Securities Act of 1933,
as amended, except as shall be expressly set forth by specific reference in such
a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
99.1 Presentation by Leonard S. Schleifer, M.D., Ph.D., President and Chief
Executive Officer of Regeneron Pharmaceuticals, Inc., and George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of
Regeneron Pharmaceuticals, Inc., at the virtual 39th Annual J.P. Morgan
Healthcare Conference.
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,
whether and to what extent Regeneron will be able to supply the remaining doses
of the casirivimab and imdevimab antibody cocktail under the terms of the
agreement with U.S. government referenced in this Report (the "Manufacturing and
Supply Agreement"), the amount of future payments (if any) Regeneron may receive
pursuant to the Manufacturing and Supply Agreement, and whether the
Manufacturing and Supply Agreement is terminated by the U.S. government or
otherwise prior to completion; and 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. 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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