Item 2.02. Results of Operations and Financial Condition. Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”) currently expects that its financial results calculated in accordance with U.S.…
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
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Item 2.02Item 2.02 - Results of Operations
Item 2.02. Results of Operations and Financial Condition.
Regeneron Pharmaceuticals, Inc. (“Regeneron”
or 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 second quarter 2026 will include an acquired
in-process research and development (“IPR&D”) charge of approximately $127 million on a pre-tax basis. This charge
relates to up-front and opt-in payments in connection with collaboration and licensing agreements. The acquired IPR&D charge is expected
to negatively impact each of GAAP and non-GAAP net income per diluted share for the second quarter 2026 by approximately $1.00.
Acquired IPR&D charges may include IPR&D
acquired in connection with asset acquisitions as well as up-front, opt-in, certain development milestone payments, and premiums paid
on equity securities 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.
Regeneron’s results for the second quarter
2026 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.
The information included in this Current Report
on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor
shall such information 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.
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 expected
acquired in-process research and development charge for the quarterly period ended June 30, 2026 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.