Current Report Filing (8-k)
January 09 2023 - 7:50AM
Edgar (US Regulatory)
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2023-01-09
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
January 9, 2023 (January 9, 2023)
REGENERON PHARMACEUTICALS, INC.
(Exact name of registrant as specified
in its charter)
New York
(State or other
jurisdiction of incorporation)
000-19034 |
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13-3444607 |
(Commission
File Number) |
|
(I.R.S.
Employer
Identification
No.)
|
|
|
777 Old Saw Mill River Road, Tarrytown, New York |
|
10591-6707 |
(Address
of principal executive offices) |
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(Zip
Code) |
Registrant’s telephone number,
including area code: (914) 847-7000
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions
A.2. below):
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title
of each class |
Trading
Symbol(s) |
Name
of each exchange on which registered |
Common Stock – par value $0.001 per share |
REGN |
NASDAQ Global Select Market |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. |
Results of Operations and Financial Condition. |
On
January 9, 2023, at the 41st 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 $6.26 billion for
the full year 2022 (based on preliminary (unaudited) fourth quarter 2022 U.S. net product sales of EYLEA of approximately $1.50 billion).
With respect to the preliminary (unaudited) fourth quarter 2022 U.S. net product sales of EYLEA, the presentation further notes the following:
| · | Negatively impacted by a short-term shift to off-label use of
compounded Avastin® (bevacizumab) |
| · | Temporary closing in Q4 2022 of fund that provides patient co-pay
assistance |
| · | Most recent Q4 2022 market data suggests that shift to off-label
Avastin is already beginning to reverse |
The presentation also includes information regarding
the Company’s current expectation that its financial results calculated in accordance with U.S. generally accepted accounting principles
(“GAAP”) and its non-GAAP financial results for the fourth quarter 2022 and full year 2022 will include an acquired
in-process research and development (“IPR&D”) charge of approximately $30 million relating to an up-front payment
in connection with the Company’s previously announced collaboration and licensing agreement with CytomX Therapeutics, Inc. This
acquired IPR&D charge is expected to negatively impact each of GAAP and non-GAAP net income per diluted share for the fourth quarter
2022 by approximately $0.21.
Regeneron’s results for the fourth quarter
and full year 2022 have not been finalized and are subject to Regeneron’s financial statement closing procedures. There can be no
assurance that actual results will not differ from the preliminary (unaudited) estimates described herein.
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 41st Annual J.P. Morgan Healthcare Conference. |
104 |
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Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document. |
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, Regeneron’s expectations
with respect to commercialization of its marketed products (including EYLEA® (aflibercept)
Injection), competitive and other relevant developments affecting the market share of Regeneron’s marketed products, and other
relevant factors (whether within or without Regeneron’s control) impacting the degree to which commercialization of Regeneron’s
marketed products is successful, as well as the impact of any of the foregoing on Regeneron’s results of operations; Regeneron’s
expected acquired in-process research and development charge in the quarterly period ended December 31, 2022 and its expected impact
on GAAP and non-GAAP net income per diluted share for the quarterly period then ended as discussed in this Report; and the potential
for any license, collaboration, or supply agreement, including Regeneron's agreement with CytomX Therapeutics, Inc. referenced in this
Report, to be cancelled or terminated. 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. 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.
Note Regarding Non-GAAP Financial Measures
This Report includes non-GAAP net income per
diluted share, which is a financial measure that is not calculated in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”).
This non-GAAP financial measure is computed by excluding certain non-cash and/or other items from the related GAAP financial measure.
The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. The Company makes such adjustments
for items the Company does not view as useful in evaluating its operating performance. Management uses this and other non-GAAP measures
for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides
forecasts to investors on this basis. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial
performance of the Company's core business operations. However, there are limitations in the use of such non-GAAP financial measures as
they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable
with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental
to, and not a substitute for, measures of financial performance prepared in accordance with GAAP.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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REGENERON PHARMACEUTICALS, INC. |
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/s/ Joseph J. LaRosa |
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Joseph J. LaRosa |
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Executive Vice President, General Counsel and Secretary |
Date: January 9, 2023
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