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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 12, 2026
REGENERON PHARMACEUTICALS, INC.
(Exact name of registrant as specified
in its charter)
New York
(State or other
jurisdiction of incorporation)
| 000-19034 |
|
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) |
|
(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 Instruction
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 12, 2026, at the 44th Annual J.P.
Morgan Healthcare Conference, Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc.
(“Regeneron” or the “Company”), and George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President
and Chief Scientific Officer of Regeneron, are providing a corporate update. The presentation contains certain preliminary (unaudited)
financial information for the fourth quarter and full year 2025. A copy of the presentation is being furnished to the Securities and Exchange
Commission as Exhibit 99.1 to this Current Report on Form 8-K, and incorporated by reference in this Item 2.02.
Q4 2025 IPR&D Charge. The Company currently
expects 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 2025 will include an acquired in-process research and development (“IPR&D”)
charge of approximately $19 million on a pre-tax basis. 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 2025 by approximately $0.14. Acquired IPR&D charges may include IPR&D
acquired in connection with asset acquisitions as well as premiums paid on equity securities and up-front, opt-in, and certain development
milestone payments related to collaboration and licensing agreements. Regeneron does not forecast such acquired IPR&D charges due
to the uncertainty of the future occurrence, magnitude, and timing of these transactions in any given period.
Q4 2025 Matching Program Contribution.
As previously disclosed, Regeneron launched a matching program for donations to Good Days, an independent national non-profit charitable
organization, to support Good Days’ Retinal Vascular and Neovascular Disease Fund (the “Fund”).
As part of this program, Regeneron committed to matching donations of up to a total of $200 million at a one-to-one rate for the remainder
of the 2025 calendar year. Regeneron was notified of approximately $60 million in donations received by the Fund in the fourth quarter
of 2025, resulting in a corresponding charge for Regeneron’s matching contribution recorded to selling, general, and administrative
expenses.
* * *
Regeneron’s results for the fourth quarter
and full year 2025 included or incorporated by reference in this Current Report on Form 8-K 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 or incorporated by reference 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 or incorporated 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, dated January 12, 2026, by Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc., and George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer of Regeneron Pharmaceuticals, Inc., at the 44th Annual J.P. Morgan Healthcare Conference. |
| |
|
|
| 104 |
|
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, 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; and Regeneron’s expected acquired in-process research and development charge for the quarterly period ended
December 31, 2025 and its expected impact on GAAP and non-GAAP net income per diluted share for this period as discussed in this
Report. 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 references 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 hereunto duly authorized.
| |
REGENERON PHARMACEUTICALS, INC. |
| |
|
| |
/s/ Joseph J. LaRosa |
| |
Joseph J. LaRosa |
| |
Executive Vice President, General Counsel and Secretary |
Date: January 12, 2026
