UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)
☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the quarterly period ended March 31, 2024
	OR
☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the transition period from __________ to __________

Commission File Number: 000-19034

REGENERON PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

New York	13-3444607
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

777 Old Saw Mill River Road, Tarrytown, New York 10591-6707

(Address of principal executive offices, including zip code)

(914) 847-7000

(Registrant's telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock - par value $.001 per share	REGN	NASDAQ Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.	Yes	☒	No	☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).	Yes	☒	No	☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ 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.		☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).	Yes	☐	No	☒

The number of shares outstanding of each of the registrant's classes of common stock as of April 16, 2024:

Class of Common Stock	Number of Shares
Class A Stock, $.001 par value	1,818,146
Common Stock, $.001 par value	108,367,357

REGENERON PHARMACEUTICALS, INC.

QUARTERLY REPORT ON FORM 10-Q

TABLE OF CONTENTS

		Page Numbers
PART I	FINANCIAL INFORMATION
Item 1.	Financial Statements (unaudited)	2
	Condensed Consolidated Balance Sheets	2
	Condensed Consolidated Statements of Operations and Comprehensive Income	3
	Condensed Consolidated Statements of Stockholders' Equity	4
	Condensed Consolidated Statements of Cash Flows	5
	Notes to Condensed Consolidated Financial Statements	6
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	23
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	42
Item 4.	Controls and Procedures	43
PART II	OTHER INFORMATION
Item 1.	Legal Proceedings	43
Item 1A.	Risk Factors	43
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	77
Item 5.	Other Information	77
Item 6.	Exhibits	78
SIGNATURE PAGE		79

"Altibodies™," "ARCALYST®," "Evkeeza®," "EYLEA®," "EYLEA® HD," "Inmazeb®," "Libtayo®," "Praluent®" (in the United States), "REGEN-COV®," "Regeneron®," "Regeneron Genetics Center®," "RGC®," "Veloci-Bi®," "VelociGene®," "VelociHum®," "VelociMab®," "VelocImmune®," "VelociMouse®," "VelociSuite®," "VelociT®," "Veopoz®," and "ZALTRAP®" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners. This report refers to products of Regeneron Pharmaceuticals, Inc., its collaborators, and other parties. Consult the product label in each territory for specific information about such products.

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

REGENERON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

(In millions, except per share data)

	March 31,		December 31,
	2024		2023
ASSETS
Current assets:
Cash and cash equivalents	$	2,602.0	$	2,730.0
Marketable securities	7,917.5		8,114.8
Accounts receivable, net	5,222.2		5,667.3
Inventories	2,714.9		2,580.5
Prepaid expenses and other current assets	414.9		386.6
Total current assets	18,871.5		19,479.2
Marketable securities	6,978.8		5,396.5
Property, plant, and equipment, net	4,225.5		4,146.4
Intangible assets, net	1,058.7		1,038.6
Deferred tax assets	2,764.9		2,575.4
Other noncurrent assets	470.2		444.1
Total assets	$	34,369.6	$	33,080.2
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	671.3	$	606.6
Accrued expenses and other current liabilities	2,392.9		2,357.9
Deferred revenue	516.7		458.9
Total current liabilities	3,580.9		3,423.4
Long-term debt	1,983.3		1,982.9
Finance lease liabilities	720.0		720.0
Deferred revenue	185.8		126.7
Other noncurrent liabilities	908.5		854.1
Total liabilities	7,378.5		7,107.1
Stockholders' equity:
Preferred Stock, par value $.01 per share; 30.0 shares authorized; shares issued and outstanding - none	—		—
Class A Stock, convertible, par value $.001 per share; 40.0 shares authorized; shares issued and outstanding - 1.8 in 2024 and 2023	—		—
Common Stock, par value $.001 per share; 320.0 shares authorized; shares issued - 134.2 in 2024 and 133.1 in 2023	0.1		0.1
Additional paid-in capital	11,942.6		11,354.0
Retained earnings	27,982.3		27,260.3
Accumulated other comprehensive loss	(77.2)		(80.9)
Treasury Stock, at cost; 25.8 shares in 2024 and 25.5 shares in 2023	(12,856.7)		(12,560.4)
Total stockholders' equity	26,991.1		25,973.1
Total liabilities and stockholders' equity	$	34,369.6	$	33,080.2
The accompanying notes are an integral part of the financial statements.

2

REGENERON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Unaudited)

(In millions, except per share data)

	Three Months Ended March 31,
	2024		2023
Statements of Operations
Revenues:
Net product sales	$	1,761.3	$	1,668.0
Collaboration revenue	1,266.8		1,378.1
Other revenue	116.9		116.0
	3,145.0		3,162.1
Expenses:
Research and development	1,248.4		1,101.2
Acquired in-process research and development	7.1		56.1
Selling, general, and administrative	689.0		601.1
Cost of goods sold	240.4		208.4
Cost of collaboration and contract manufacturing	193.4		249.1
Other operating expense (income), net	15.3		(0.5)
	2,393.6		2,215.4
Income from operations	751.4		946.7
Other income (expense):
Other (expense) income, net	(34.6)		(70.7)
Interest expense	(16.1)		(18.0)
	(50.7)		(88.7)
Income before income taxes	700.7		858.0
Income tax (benefit) expense	(21.3)		40.2
Net income	$	722.0	$	817.8
Net income per share - basic	$	6.70	$	7.64
Net income per share - diluted	$	6.27	$	7.17
Weighted average shares outstanding - basic	107.8		107.1
Weighted average shares outstanding - diluted	115.1		114.0
Statements of Comprehensive Income
Net income	$	722.0	$	817.8
Other comprehensive income (loss), net of tax:
Unrealized gain on debt securities	3.5		57.2
Gain on foreign currency translation	0.2		—
Comprehensive income	$	725.7	$	875.0
The accompanying notes are an integral part of the financial statements.

3

REGENERON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited)

(In millions)

	Class A Stock			Common Stock			Additional Paid-in Capital		Retained Earnings		Accumulated Other Comprehensive Income (Loss)		Treasury Stock			Total Stockholders' Equity
	Shares	Amount		Shares	Amount								Shares	Amount
Balance, December 31, 2023	1.8	$	—	133.1	$	0.1	$	11,354.0	$	27,260.3	$	(80.9)	(25.5)	$	(12,560.4)	$	25,973.1
Issuance of Common Stock for equity awards granted under long-term incentive plans	—	—		1.5	—		672.4		—		—		—	—		672.4
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations	—	—		(0.4)	—		(335.9)		—		—		—	—		(335.9)
Issuance/distribution of Common Stock for 401(k) Savings Plan	—	—		—	—		18.8		—		—		—	1.7		20.5
Repurchases of Common Stock	—	—		—	—		—		—		—		(0.3)	(298.0)		(298.0)
Stock-based compensation charges	—	—		—	—		233.3		—		—		—	—		233.3
Net income	—	—		—	—		—		722.0		—		—	—		722.0
Other comprehensive income, net of tax	—	—		—	—		—		—		3.7		—	—		3.7
Balance, March 31, 2024	1.8	$	—	134.2	$	0.1	$	11,942.6	$	27,982.3	$	(77.2)	(25.8)	$	(12,856.7)	$	26,991.1
Balance, December 31, 2022	1.8	$	—	130.4	$	0.1	$	9,949.3	$	23,306.7	$	(238.8)	(22.6)	$	(10,353.3)	$	22,664.0
Issuance of Common Stock for equity awards granted under long-term incentive plans	—	—		1.1	—		491.3		—		—		—	—		491.3
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations	—	—		(0.1)	—		(99.2)		—		—		—	—		(99.2)
Issuance/distribution of Common Stock for 401(k) Savings Plan	—	—		—	—		18.9		—		—		—	1.7		20.6
Repurchases of Common Stock	—	—		—	—		—		—		—		(0.9)	(693.9)		(693.9)
Stock-based compensation charges	—	—		—	—		237.4		—		—		—	—		237.4
Net income	—	—		—	—		—		817.8		—		—	—		817.8
Other comprehensive income, net of tax	—	—		—	—		—		—		57.2		—	—		57.2
Balance, March 31, 2023	1.8	$	—	131.4	$	0.1	$	10,597.7	$	24,124.5	$	(181.6)	(23.5)	$	(11,045.5)	$	23,495.2
The accompanying notes are an integral part of the financial statements.

4

REGENERON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

(In millions)

	Three Months Ended March 31,
	2024		2023
Cash flows from operating activities:
Net income	$	722.0	$	817.8
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization	114.1		99.5
Stock-based compensation expense	230.1		238.7
Losses on marketable and other securities, net	196.1		166.6
Other non-cash items, net	0.1		20.6
Deferred income taxes	(190.4)		(216.5)
Changes in assets and liabilities:
Decrease in accounts receivable	446.8		210.1
Increase in inventories	(155.8)		(46.8)
Increase in prepaid expenses and other assets	(77.9)		(5.5)
Increase (decrease) in deferred revenue	116.9		(35.9)
Increase in accounts payable, accrued expenses, and other liabilities	110.5		119.0
Total adjustments	790.5		549.8
Net cash provided by operating activities	1,512.5		1,367.6
Cash flows from investing activities:
Purchases of marketable and other securities	(5,657.5)		(1,749.4)
Sales or maturities of marketable and other securities	4,132.2		1,792.8
Capital expenditures	(133.9)		(178.2)
Payments for Libtayo intangible asset	(27.9)		(100.9)
Net cash used in investing activities	(1,687.1)		(235.7)
Cash flows from financing activities:
Proceeds from issuance of Common Stock	682.1		485.2
Payments in connection with Common Stock tendered for employee tax obligations	(343.7)		(97.0)
Repurchases of Common Stock	(291.3)		(710.7)
Net cash provided by (used in) financing activities	47.1		(322.5)
Effect of exchange rate changes on cash, cash equivalents, and restricted cash	(0.5)		—
Net (decrease) increase in cash, cash equivalents, and restricted cash	(128.0)		809.4
Cash, cash equivalents, and restricted cash at beginning of period	2,737.8		3,119.4
Cash, cash equivalents, and restricted cash at end of period	$	2,609.8	$	3,928.8
The accompanying notes are an integral part of the financial statements.

5

REGENERON PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

1. Interim Financial Statements

Basis of Presentation

The interim Condensed Consolidated Financial Statements of Regeneron Pharmaceuticals, Inc. and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company's financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America. In the opinion of management, these financial statements reflect all normal recurring adjustments and accruals necessary for a fair statement of the Company's condensed consolidated financial statements for such periods. The results of operations for any interim period are not necessarily indicative of the results for the full year. The December 31, 2023 Condensed Consolidated Balance Sheet data were derived from audited financial statements, but do not include all disclosures required by accounting principles generally accepted in the United States of America. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Recently Issued Accounting Standards

In November 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update No. 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures. The amendments require disclosure of incremental segment information on an annual and interim basis. The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in Accounting Standards Codification 280, Segment Reporting. The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.

In December 2023, the FASB issued Accounting Standards Update No. 2023-09, Income Taxes - Improvements to Income Tax Disclosures. The amendments require (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. The amendments are effective for annual periods beginning after December 15, 2024. The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.

6

2. Product Sales

Net product sales consist of the following:

		Three Months Ended March 31,
(In millions)		2024		2023
EYLEA® HD	U.S.	$	200.0	$	—
EYLEA®	U.S.	1,201.6		1,433.8
Total EYLEA HD and EYLEA	U.S.	1,401.6		1,433.8
Libtayo®	U.S.	159.2		109.7
Libtayo	ROW(a)	104.7		67.2
Total Libtayo	Global	263.9		176.9
Praluent®	U.S.	70.0		40.2
Evkeeza®	U.S.	24.8		14.9
Inmazeb®	Global	1.0		2.2
		$	1,761.3	$	1,668.0
(a) Rest of world ("ROW")

As of March 31, 2024 and December 31, 2023, the Company had $3.739 billion and $3.888 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.

The Company had product sales to certain customers that accounted for more than 10% of total gross product revenue for the three months ended March 31, 2024 and 2023. Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows:

	Three Months Ended March 31,
	2024		2023
Besse Medical, a subsidiary of Cencora, Inc.	51	%	52	%
McKesson Corporation	24	%	25	%

3. Collaboration, License, and Other Agreements

a. Sanofi

The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent® (dupilumab), Kevzara® (sarilumab), and itepekimab.

Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. The Company is obligated to reimburse Sanofi for 30% to 50% of worldwide development expenses that were funded by Sanofi (i.e., "development balance") based on the Company's share of collaboration profits; however, the Company is only required to apply 20% of its share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of March 31, 2024, the Company's contingent reimbursement obligation to Sanofi under the collaboration was approximately $2.200 billion.

Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products.

7

Amounts recognized in the Company's Statements of Operations in connection with its Sanofi collaboration are as follows:

	Statement of Operations Classification	Three Months Ended March 31,
(In millions)		2024		2023
Regeneron's share of profits in connection with commercialization of antibodies	Collaboration revenue	$	804.0	$	636.5
Reimbursement for manufacturing of commercial supplies	Collaboration revenue	$	105.8	$	161.9
Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses	(R&D expense)	$	(18.6)	$	(26.4)
Reimbursement of commercialization-related expenses	Reduction of SG&A expense	$	139.5	$	117.6

The following table summarizes contract balances in connection with the Company's Sanofi collaboration:

	March 31,		December 31,
(In millions)	2024		2023
Accounts receivable, net	$	947.0	$	1,029.1
Deferred revenue	$	532.2	$	427.7

b. Bayer

The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept) outside the United States. Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. Within the United States, the Company is responsible for commercialization and retains profits from such sales. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.

Amounts recognized in the Company's Statements of Operations in connection with its Bayer collaboration are as follows:

	Statement of Operations Classification	Three Months Ended March 31,
(In millions)		2024		2023
Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States	Collaboration revenue	$	333.9	$	331.6
Reimbursement for manufacturing of ex-U.S. commercial supplies	Collaboration revenue	$	22.1	$	25.3
Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses	(R&D expense)	$	(8.7)	$	(13.4)

The following table summarizes contract balances in connection with the Company's Bayer collaboration:

	March 31,		December 31,
(In millions)	2024		2023
Accounts receivable, net	$	359.0	$	381.7
Deferred revenue	$	151.1	$	138.2

8

c. Alnylam

The Company is party to a collaboration agreement with Alnylam Pharmaceuticals, Inc. to discover, develop, and commercialize RNA interference therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver. For each program, the Company provides Alnylam with a specified amount of funding at program initiation and at lead candidate designation. Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates. Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development/co-commercialization collaboration agreement or license agreement.

Amounts recognized in the Company's Statements of Operations in connection with its Alnylam collaboration are as follows:

	Statement of Operations Classification	Three Months Ended March 31,
(In millions)		2024		2023
Regeneron's obligation for its share of Alnylam R&D expenses, net of reimbursement of R&D expenses	(R&D expense)	$	(17.5)	$	(21.3)

The following table summarizes contract balances in connection with the Company's Alnylam collaboration:

	March 31,		December 31,
(In millions)	2024		2023
Accrued expenses and other current liabilities	$	18.9	$	22.6

d. Roche

The Company is a party to a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV® in the United States and Ronapreve™ in other countries). Under the terms of the collaboration agreement, the parties jointly fund certain studies, and the Company has the right to distribute the product in the United States while Roche has the right to distribute the product outside the United States. The parties share gross profits from worldwide sales based on a pre-specified formula, depending on the amount of manufactured product supplied by each party to the market.

Amounts recognized in the Company's Statements of Operations in connection with its Roche collaboration are as follows:

	Statement of Operations Classification	Three Months Ended March 31,
(In millions)		2024		2023
Global gross profit payment from Roche in connection with sales of Ronapreve	Collaboration revenue	$	0.5	$	222.2

Reimbursement of research and development expenses from Roche was not material for the three months ended March 31, 2024 and 2023.

Contract balances in the Company's Balance Sheets in connection with the Roche collaboration were not material as of March 31, 2024 and December 31, 2023.

e. Sonoma

In March 2023, the Company and Sonoma Biotherapeutics, Inc. entered into a license and collaboration agreement to bring together the Company's VelociSuite® technologies with Sonoma's technology platform for the discovery, development, and commercialization of novel regulatory T cell ("Treg") therapies for autoimmune diseases. In connection with the agreement, the Company made a $45.0 million up-front payment (which was recorded to Acquired in-process research and development expense in the first quarter of 2023) and, in April 2023, the Company purchased an aggregate of $30.0 million of Sonoma preferred stock. Sonoma is also eligible to receive a $45.0 million development milestone payment. The parties co-fund research and development activities under the collaboration.

9

Amounts recognized in the Company's Statements of Operations in connection with research and development activities co-funded under the Sonoma collaboration were not material for the three months ended March 31, 2024. In addition, contract balances in the Company's Balance Sheets in connection with the Sonoma collaboration were not material as of March 31, 2024 and December 31, 2023.

4. Net Income Per Share

Basic net income per share is computed by dividing net income by the weighted average number of shares of Common Stock and Class A Stock outstanding. Net income per share is presented on a combined basis, inclusive of Common Stock and Class A Stock outstanding, as each class of stock has equivalent economic rights. Diluted net income per share includes the potential dilutive effect of other securities as if such securities were converted or exercised during the period, when the effect is dilutive. The calculations of basic and diluted net income per share are as follows:

	Three Months Ended March 31,
(In millions, except per share data)	2024		2023
Net income - basic and diluted	$	722.0	$	817.8
Weighted average shares - basic	107.8		107.1
Effect of dilutive securities:
Stock options	5.3		5.0
Restricted stock awards and restricted stock units	2.0		1.9
Weighted average shares - diluted	115.1		114.0
Net income per share - basic	$	6.70	$	7.64
Net income per share - diluted	$	6.27	$	7.17

Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following:

	Three Months Ended March 31,
(Shares in millions)	2024	2023
Stock options	1.5	1.7

10

5. Marketable Securities

Marketable securities as of March 31, 2024 and December 31, 2023 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).

The following tables summarize the Company's investments in available-for-sale debt securities:

(In millions)	Amortized		Unrealized				Fair
As of March 31, 2024	Cost Basis		Gains		Losses		Value
Corporate bonds	$	7,478.9	$	6.1	$	(83.9)	$	7,401.1
U.S. government and government agency obligations	5,291.2		0.4		(18.2)		5,273.4
Sovereign bonds	59.8		—		(0.8)		59.0
Commercial paper	867.1		0.3		(0.5)		866.9
Certificates of deposit	389.7		0.2		—		389.9
Asset-backed securities	126.0		—		(1.3)		124.7
	$	14,212.7	$	7.0	$	(104.7)	$	14,115.0
As of December 31, 2023
Corporate bonds	$	6,492.5	$	10.4	$	(104.9)	$	6,398.0
U.S. government and government agency obligations	4,839.6		2.4		(8.6)		4,833.4
Sovereign bonds	58.1		—		(0.9)		57.2
Commercial paper	636.8		0.2		(0.2)		636.8
Certificates of deposit	520.8		0.6		—		521.4
Asset-backed securities	88.2		0.1		(1.2)		87.1
	$	12,636.0	$	13.7	$	(115.8)	$	12,533.9

The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates. The available-for-sale debt securities as of March 31, 2024 mature at various dates through June 2029. The fair values of available-for-sale debt securities by contractual maturity consist of the following:

	March 31,		December 31,
(In millions)	2024		2023
Maturities within one year	$	7,917.5	$	8,114.8
Maturities after one year through five years	6,184.1		4,414.5
Maturities after five years	13.4		4.6
	$	14,115.0	$	12,533.9

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The following table shows the fair value of the Company's available-for-sale debt securities that have unrealized losses, aggregated by investment category and length of time that the individual securities have been in a continuous loss position.

	Less than 12 Months				12 Months or Greater				Total
(In millions) As of March 31, 2024	Fair Value		Unrealized Loss		Fair Value		Unrealized Loss		Fair Value		Unrealized Loss
Corporate bonds	$	4,490.4	$	(10.7)	$	2,910.7	$	(73.2)	$	7,401.1	$	(83.9)
U.S. government and government agency obligations	5,220.4		(15.9)		53.0		(2.3)		5,273.4		(18.2)
Sovereign bonds	32.5		(0.2)		26.5		(0.6)		59.0		(0.8)
Commercial paper	866.9		(0.5)		—		—		866.9		(0.5)
Asset-backed securities	99.2		(0.6)		25.5		(0.7)		124.7		(1.3)
	$	10,709.4	$	(27.9)	$	3,015.7	$	(76.8)	$	13,725.1	$	(104.7)
As of December 31, 2023
Corporate bonds	$	2,363.3	$	(2.4)	$	4,034.7	$	(102.5)	$	6,398.0	$	(104.9)
U.S. government and government agency obligations	4,780.6		(6.0)		52.7		(2.6)		4,833.3		(8.6)
Sovereign bonds	12.4		(0.1)		44.8		(0.8)		57.2		(0.9)
Commercial paper	636.8		(0.2)		—		—		636.8		(0.2)
Asset-backed securities	61.8		(0.3)		25.3		(0.9)		87.1		(1.2)
	$	7,854.9	$	(9.0)	$	4,157.5	$	(106.8)	$	12,012.4	$	(115.8)

The unrealized losses on corporate bonds as of March 31, 2024 were primarily driven by increased interest rates. The Company has reviewed its portfolio of available-for-sale debt securities and determined that the decline in fair value below cost did not result from credit-related factors. In addition, the Company does not intend to sell, and it is not more likely than not that the Company will be required to sell, such securities before recovery of their amortized cost bases.

With respect to marketable securities, for the three months ended March 31, 2024 and 2023, amounts reclassified from Accumulated other comprehensive loss into Other (expense) income, net were related to realized gains/losses on sales of available-for-sale debt securities. For the three months ended March 31, 2024 and 2023, realized gains/losses on sales of marketable securities were not material.

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6. Fair Value Measurements

The table below summarizes the Company's assets and liabilities which are measured at fair value on a recurring basis. The following fair value hierarchy is used to classify assets and liabilities, based on inputs to valuation techniques utilized to measure fair value:

•Level 1 - Quoted prices in active markets for identical assets or liabilities

•Level 2 - Significant other observable inputs, such as quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-based valuations in which significant inputs used are observable

•Level 3 - Significant other unobservable inputs

(In millions)			Fair Value Measurements at Reporting Date
As of March 31, 2024	Fair Value		Level 1		Level 2		Level 3
Assets:
Cash equivalents	$	1,056.4	$	125.8	$	930.6	$	—
Available-for-sale debt securities:
Corporate bonds	7,401.1		—		7,401.1		—
U.S. government and government agency obligations	5,273.4		—		5,273.4		—
Sovereign bonds	59.0		—		59.0		—
Commercial paper	866.9		—		866.9		—
Certificates of deposit	389.9		—		389.9		—
Asset-backed securities	124.7		—		124.7		—
Equity securities (unrestricted)	679.4		679.4		—		—
Equity securities (restricted)	101.9		101.9		—		—
Total assets	$	15,952.7	$	907.1	$	15,045.6	$	—
Liabilities:
Contingent consideration	$	59.0	$	—	$	—	$	59.0
As of December 31, 2023
Assets:
Cash equivalents	$	928.1	$	6.4	$	921.7	$	—
Available-for-sale debt securities:
Corporate bonds	6,398.0		—		6,398.0		—
U.S. government and government agency obligations	4,833.4		—		4,833.4		—
Sovereign bonds	57.2		—		57.2		—
Commercial paper	636.8		—		636.8		—
Certificates of deposit	521.4		—		521.4		—
Asset-backed securities	87.1		—		87.1		—
Equity securities (unrestricted)	864.5		864.5		—		—
Equity securities (restricted)	112.9		112.9		—		—
Total assets	$	14,439.4	$	983.8	$	13,455.6	$	—
Liabilities:
Contingent consideration	$	43.7	$	—	$	—	$	43.7

As of March 31, 2024, the Company held restricted equity securities which are subject to transfer restrictions that expire in June 2024.

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During the three months ended March 31, 2024 and 2023, the Company recorded $196.2 million and $164.7 million, respectively, of net unrealized losses on equity securities in Other (expense) income, net.

In addition to the investments summarized in the table above, as of March 31, 2024 and December 31, 2023, the Company had $73.7 million and $74.3 million, respectively, in equity investments that do not have a readily determinable fair value. These investments are recorded within Other noncurrent assets.

As a result of the Company's acquisition of Decibel Therapeutics, Inc. in September 2023, the Company recorded a contingent consideration liability within other liabilities. The fair value of the liability is determined based on the probability of achieving certain clinical development and regulatory milestones and estimated discount rates, and is remeasured each reporting period until the contingencies are resolved. During the three months ended March 31, 2024, the Company recorded a $15.3 million charge related to the change in the estimated fair value of the contingent consideration liability within Other operating expense (income), net.

The fair value of the Company's long-term debt, which was determined based on Level 2 inputs, was estimated to be $1.497 billion and $1.528 billion as of March 31, 2024 and December 31, 2023, respectively.

7. Inventories

Inventories consist of the following:

	March 31,		December 31,
(In millions)	2024		2023
Raw materials	$	814.8	$	789.3
Work-in-process	1,108.1		1,121.8
Finished goods	180.5		147.3
Deferred costs	611.5		522.1
	$	2,714.9	$	2,580.5

Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred.

8. Income Taxes

The Company is subject to U.S. federal, state, and foreign income taxes. The Company's effective tax rate was (3.0%) and 4.7% for the three months ended March 31, 2024 and 2023, respectively. The Company's effective tax rate for the three months ended March 31, 2024 and 2023 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation and income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate. The effective tax rate for the three months ended March 31, 2024 was positively impacted, compared to the same period in 2023, primarily by additional stock-based compensation.

9. Stockholders' Equity

In November 2021, the Company's board of directors authorized a share repurchase program to repurchase up to $3.0 billion of the Company's Common Stock. As of June 30, 2023, the Company had repurchased the entire $3.0 billion of its Common Stock that it was authorized to repurchase under the program.

In January 2023, the Company's board of directors authorized an additional share repurchase program to repurchase up to $3.0 billion of the Company's Common Stock. The share repurchase program permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act. Repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors. The program has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases in the future. As of March 31, 2024, $1.233 billion remained available for share repurchases under the program.

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The table below summarizes the shares of the Company's Common Stock the Company repurchased and the cost of the shares, which were recorded as Treasury Stock.

	Three Months Ended March 31,
(In millions)	2024		2023
Number of shares	0.3		0.9
Total cost of shares	$	298.0	$	693.9

In April 2024, the Company's board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of the Company's Common Stock. The share repurchase program was approved under terms substantially similar to the share repurchase programs described above.

10. Statement of Cash Flows

The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows:

	March 31,
(In millions)	2024		2023
Cash and cash equivalents	$	2,602.0	$	3,916.3
Restricted cash included in Other noncurrent assets	7.8		12.5
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows	$	2,609.8	$	3,928.8

Restricted cash consists of amounts held by financial institutions pursuant to contractual arrangements.

Supplemental disclosure of non-cash investing and financing activities

	March 31,		December 31,		March 31,		December 31,
(In millions)	2024		2023		2023		2022
Accrued capital expenditures	$	108.0	$	75.4	$	90.3	$	70.8
Accrued contingent consideration in connection with acquisitions	$	88.8	$	71.6	$	55.2	$	135.5

11. Legal Matters

From time to time, the Company is a party to legal proceedings in the course of the Company's business. The outcome of any such proceedings, regardless of the merits, is inherently uncertain. If the Company were unable to prevail in any such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially impacted. Costs associated with the Company's involvement in legal proceedings are expensed as incurred. The Company recognizes accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. As of March 31, 2024 and December 31, 2023, the Company's accruals for loss contingencies were not material. There are certain loss contingencies that the Company deems reasonably possible for which the possible loss or range of possible loss is not estimable at this time.

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Proceedings Relating to Praluent (alirocumab) Injection

United States

On May 27, 2022, the Company filed a lawsuit against Amgen Inc. in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws. The lawsuit seeks damages for harm caused by the alleged scheme, as well as injunctive relief restraining Amgen from continuing its alleged anticompetitive conduct. On August 1 and 11, 2022, Amgen filed a motion to dismiss the complaint and a motion to stay these proceedings, respectively. On February 10, 2023, the court denied Amgen's motion to stay; and on March 21, 2023, the court denied Amgen's motion to dismiss. On August 28, 2023, the Company filed an amended complaint in this matter; and, as part of its response, on September 20, 2023, Amgen filed a counterclaim alleging that the Company engaged in unfair business practices in violation of state law. A trial has been scheduled to begin in November 2024.

Europe

On June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the Unified Patent Court (the "UPC") alleging infringement of Amgen's European Patent No. 3,666,797 (the "'797 Patent"). The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages. The '797 Patent is a divisional patent of European Patent No. 2,215,124 (the "'124 Patent") (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent), which was previously invalidated by Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO"). A trial has been scheduled for October 16–17, 2024. Also on June 1, 2023, Sanofi filed an action in the Munich Central Division of the UPC seeking revocation of the '797 Patent. A trial has been scheduled for June 4–5, 2024.

Proceedings Relating to EYLEA (aflibercept) Injection

Certain of the Company's patents pertaining to EYLEA are subject to post-grant proceedings before the United States Patent and Trademark Office ("USPTO"), EPO, or other comparable foreign authorities, including those described in greater detail below. In addition, the Company has filed patent infringement lawsuits in several jurisdictions alleging infringement of certain Company patents pertaining to EYLEA, including those described in greater detail below.

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United States

Post-Grant Proceedings Before USPTO

Company Patent(s)	Challenger(s)	Type of Challenge	Date of Challenge	Latest Events/Current Status
U.S. Patent Nos. 9,254,338 (the "'338 Patent") and 9,669,069 (the "'069 Patent")	Mylan Pharmaceuticals Inc., joined by Apotex Inc. and Celltrion	IPR petitions seeking declarations of invalidity	May 5, 2021	On November 9, 2022, the USPTO issued final written decisions finding that the challenged claims of the '338 and '069 Patents are unpatentable and, therefore, invalid. On January 10, 2023, the Company filed notices of appeal of these decisions to the United States Court of Appeals for the Federal Circuit (the "Federal Circuit").
U.S. Patent Nos. 10,130,681 (the "'681 Patent") and 10,888,601 (the "'601 Patent")	Mylan, joined by Celltrion ('601 and '681 Patents) and Samsung Bioepis Co., Ltd. ('601 Patent)	IPR petitions seeking declarations of invalidity	July 1, 2022	On January 9, 2024, the USPTO issued final written decisions finding that that the challenged claims of the '681 and '601 Patents are unpatentable and, therefore, invalid. On March 12, 2024, the Company filed notices of appeal of these decisions to the Federal Circuit.
	Samsung Bioepis, joined by Biocon Biologics Inc. ('601 Patent)	IPR petitions seeking declarations of invalidity	January 6, 2023 ('681 Patent) March 26, 2023 ('601 Patent)	On July 19, 2023 and October 20, 2023, the USPTO instituted IPR proceedings concerning the '681 Patent and the '601 Patent, respectively.
U.S. Patent No. 11,253,572 (the "'572 Patent")	Samsung Bioepis	IPR petition seeking declaration of invalidity	April 27, 2023	On November 17, 2023, the USPTO instituted IPR proceedings concerning the '572 Patent.

U.S. Patent Litigation

On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan, a wholly-owned subsidiary of Viatris Inc., in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On April 20, 2023, Mylan filed a motion for summary judgment or partial summary judgment concerning four of the asserted patents. On April 26, 2023, the Company filed a stipulation accepting summary judgment of noninfringement of all asserted claims of the Company's U.S. Patent No. 11,104,715. On June 5, 2023, Biocon, as successor-in-interest to the aflibercept 2 mg biosimilar, was joined as a defendant to the lawsuit. A trial was held from June 12, 2023 through June 23, 2023 concerning certain claims of the '601 Patent, the '572 Patent, and the Company's U.S. Patent No. 11,084,865 (the "'865 Patent"). On December 27, 2023, the court issued a decision finding that (i) the asserted claims of the '865 Patent were valid and infringed by Mylan and (ii) the asserted claims of the '601 and '572 Patents were infringed by Mylan but were invalid as obvious. A scheduling conference has been set for May 17, 2024.

On November 8, November 22, and November 29, 2023, respectively, the Company filed patent infringement lawsuits against Celltrion, Samsung Bioepis, and Formycon AG in the United States District Court for the Northern District of West Virginia following service on Regeneron of each company's notice of commercial marketing. The lawsuits allege that each company has infringed certain Company patents, including based on each company's filing for FDA approval of an aflibercept 2 mg biosimilar. On December 27, 2023, the Company filed a second patent infringement lawsuit against Samsung Bioepis in the United States District Court for the Northern District of West Virginia alleging that Samsung's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents. A scheduling conference has been set for May 17, 2024.

On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents. On January 11, 2024, the Company filed a motion with the United States Judicial Panel on Multidistrict Litigation seeking to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated pretrial proceedings with the lawsuits described in the preceding paragraph. On April 11, 2024, the United States Judicial Panel on Multidistrict Litigation granted the Company's motion to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated and consolidated pretrial proceedings with the lawsuits

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described in the preceding paragraph. A scheduling conference before the United States District Court for the Northern District of West Virginia has been set for May 17, 2024.

Europe

Post-Grant Proceedings

Authority/Court	Company Patent(s)	Challenger(s)	Type of Challenge	Date of Challenge	Latest Events/Current Status
EPO	European Patent No. 2,944,306 (the "'306 Patent")	Anonymous parties	Opposition proceedings	October 26 and October 27, 2021	Oral hearing scheduled for November 2024.
EPO	European Patent No. 3,716,992 (the "EP '992 Patent")	Amgen and three anonymous parties	Opposition proceedings	May 5-10, 2023	Oral hearing to be scheduled.
EPO	European Patent No. 3,384,049 (the "'049 Patent")	Amgen and anonymous parties	Opposition proceedings	April 22-30, 2024	Oral hearing to be scheduled.
German Federal Patent Court	German designation of European Patent No. 2,364,691 (the "'691 Patent")	Samsung Bioepis NL B.V.	Invalidation proceedings	June 22, 2023	Trial has been scheduled to begin in June 2025.
High Court of Justice of England and Wales	United Kingdom designations of the '691 Patent and '306 Patent	Formycon AG and Klinge Biopharma GmbH	Invalidation proceedings and declaration of non-infringement by challengers' aflibercept 2 mg biosimilar	April 18, 2024	Trial to be scheduled.

Canada

Proceedings against Viatris Canada and BCIL

In 2022, the Company and Bayer Inc. filed patent infringement lawsuits against BGP Pharma ULC d.b.a Viatris Canada ("Viatris Canada") in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's Canadian Patent Nos. 2,654,510 (the "'510 Patent") and 3,007,276 (the "'276 Patent") (in the lawsuit filed on June 15, 2022); the Company's Canadian Patent No. 2,965,495 (the "'495 Patent") (in the lawsuit filed on July 15, 2022); the Company's Canadian Patent No. 2,906,768 (the "'768 Patent") (in the lawsuit filed on August 30, 2022, which has been joined with the lawsuit filed on July 15, 2022); and the Company's Canadian Patent No. 3,129,193 (the "'193 Patent") (in the lawsuit filed on October 4, 2022). On June 5, 2023, following the transfer of Viatris Canada's New Drug Submission of its aflibercept 2 mg biosimilar to Biosimilar Collaborations Ireland Limited ("BCIL"), BCIL was added as a defendant in the lawsuit concerning the '510 Patent and the '276 Patent.

On March 23, 2023 and June 14, 2023, the Company and Bayer Inc. filed patent infringement lawsuits against BCIL in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 and '276 Patents. On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Viatris Canada and BCIL in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of Bayer Healthcare LLC's Canadian Patent No. 2,970,315 (the "'315 Patent").

On March 1, 2024, the Company, Bayer Inc., Bayer Healthcare LLC, Viatris Canada, BCIL, and Biocon Biologics Limited entered into a settlement agreement concerning the lawsuits described in the preceding two paragraphs. Pursuant to the settlement agreement, each of such lawsuits has been dismissed and BCIL is generally precluded from launching its aflibercept 2 mg biosimilar product in Canada until July 1, 2025.

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Proceedings against Amgen Canada

On May 9, 2023, Amgen Canada Inc. ("Amgen Canada") filed invalidation proceedings against the Company in the Federal Court of Canada seeking revocation of the '510 Patent and the '276 Patent. On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '315 Patent. On September 14, 2023, the Company and Bayer Inc. filed three separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '193 Patent, '495 Patent, and '768 Patent, respectively. On October 11, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed two separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 Patent and '276 Patent, respectively. A trial for the lawsuits concerning the '510 Patent and the '276 Patent has been scheduled for May 2025.

Proceedings against Celltrion

On January 15, 2024, the Company and Bayer Inc. filed patent infringement lawsuits against Celltrion, Inc., Celltrion Healthcare Co, Ltd., Celltrion Pharma Inc., and Celltrion Healthcare Canada Ltd. in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '510 Patent, the '276 Patent, the '495 Patent, the '768 Patent, the '193 Patent, and the '315 Patent.

Proceedings against Apotex

On March 6, 2024, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Apotex Inc. in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '510 Patent, the '276 Patent, the '495 Patent, the '768 Patent, the '193 Patent, and the '315 Patent. An oral hearing for certain motions concerning the '276 Patent, the '315 Patent, and the '510 Patent has been scheduled for July 8-9, 2024.

South Korea

On October 31, 2022 and December 13, 2022, Samsung Bioepis Co., Ltd. initiated invalidation proceedings before the Intellectual Property Trial and Appeal Board of the Korean Intellectual Property Office against the Company's Korean Patent Nos. 1131429 and 1406811, respectively, seeking revocation of each of such patents in its entirety.

On January 16, 2023, the Company filed patent infringement lawsuits against Samsung Bioepis Co., Ltd. and its parent company Samsung Biologics Co., Ltd. before the Seoul Central District Court seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the Company's Korean Patent No. 659477 (the "'477 Patent"). On July 20, 2023, the Company filed a preliminary injunction petition against Samsung Bioepis Co., Ltd. and its parent company Samsung Biologics Co., Ltd. before the Seoul Central District Court seeking a court order enjoining the manufacture, use, and assignment of an aflibercept 2 mg biosimilar that infringes one or more claims of the '477 Patent; and on December 20, 2023, the Seoul Central District Court granted a preliminary injunction. On January 10, 2024, the injunction was lifted against the Samsung entities following the expiration of the '477 Patent.

On March 2, 2023, the Company filed an affirmative scope confirmation action against Samsung Bioepis Co., Ltd. before the Intellectual Property Tribunal and Appeal Board of the Korean Intellectual Property Office seeking a ruling that Samsung Bioepis's aflibercept 2 mg biosimilar is covered by the claims of the '477 Patent. In March 2024, these proceedings were terminated as a result of the expiration of the '477 Patent.

Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe

On June 19, 2020, Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") filed a patent infringement lawsuit (as amended on August 2, 2021) in the U.S. District Court for the Northern District of New York asserting claims of Novartis's U.S. Patent No. 9,220,631 (the "'631 Patent") and seeking preliminary and permanent injunctions to prevent the Company from continuing to infringe the '631 Patent. Novartis also seeks a judgment of patent infringement of the '631 Patent, monetary damages (together with interest), an order of willful infringement of the '631 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuits, and attorneys' fees. On November 7, 2022, the Company and Novartis entered into a stipulation staying the lawsuit in light of the decision in the IPR proceeding discussed below.

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On July 16, 2020, the Company initiated two IPR petitions in the USPTO seeking a declaration of invalidity of the '631 Patent on two separate grounds. On October 26, 2021, the USPTO issued a decision instituting the IPR proceeding. An oral hearing was held on July 21, 2022. On October 25, 2022, the Patent Trial and Appeal Board ("PTAB") of the USPTO issued a final written decision invalidating all claims of the '631 Patent. On December 23, 2022, Novartis filed a notice of appeal of the PTAB's decision to the Federal Circuit.

On July 17, 2020, the Company filed an antitrust lawsuit against Novartis and Vetter Pharma International Gmbh ("Vetter") in the United States District Court for the Southern District of New York seeking a declaration that the '631 Patent is unenforceable and a judgment that the defendants' conduct violates Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act"). The Company is also seeking injunctive relief and treble damages. On September 4, 2020, Novartis filed, and Vetter moved to join, a motion to dismiss the complaint, to transfer the lawsuit to the Northern District of New York, or to stay the suit; and on October 19, 2020, Novartis filed, and Vetter moved to join, a second motion to dismiss the complaint on different grounds. On January 25, 2021, the Company filed an amended complaint seeking a judgment that Novartis's conduct violates Section 2 of the Sherman Antitrust Act based on additional grounds, as well as a judgment of tortious interference with contract. On February 22, 2021, Novartis filed, and Vetter moved to join, a motion to dismiss the amended complaint. On September 21, 2021, the court granted Novartis and Vetter's motion to transfer this lawsuit to the Northern District of New York. As a result, this lawsuit was transferred to the same judge that had been assigned to the patent infringement lawsuit discussed above. On January 31, 2022, the court granted Novartis and Vetter's motion to dismiss the amended complaint. On June 10, 2022, the Company filed an appeal of the District Court's decision to dismiss the amended complaint with the U.S. Court of Appeals for the Second Circuit (the "Second Circuit"). On March 18, 2024, the Second Circuit reversed the District Court's decision to dismiss the amended complaint and remanded the lawsuit to the District Court for further proceedings consistent with the Second Circuit's opinion.

Proceedings Relating to REGEN-COV (casirivimab and imdevimab)

On October 5, 2020, Allele Biotechnology and Pharmaceuticals, Inc. ("Allele") filed a lawsuit (as amended on April 8, 2021 and December 12, 2022) against the Company in the United States District Court for the Southern District of New York, asserting infringement of U.S. Patent No. 10,221,221 (the "'221 Patent"). Allele seeks a judgment of patent infringement of the '221 Patent, an award of monetary damages (together with interest), an order of willful infringement of the '221 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuit, and attorneys' fees. On July 16, 2021, the Company filed a motion to dismiss the complaint, which motion was denied on March 2, 2022. On September 18, 2023, the parties entered into a stipulation that narrowed the case to (i) whether any safe harbor defense under federal law applies to Regeneron's use of the invention covered, based on the court's claim construction, by the '221 Patent; (ii) damages for any use by Regeneron found to not be covered by such safe harbor defense; and (iii) whether any use referred to in clause (ii) above was willful.

Department of Justice Matters

In January 2017, the Company received a subpoena from the U.S. Attorney's Office for the District of Massachusetts requesting documents relating to its support of 501(c)(3) organizations that provide financial assistance to patients; documents concerning its provision of financial assistance to patients with respect to products sold or developed by Regeneron (including EYLEA, Praluent, ARCALYST®, and ZALTRAP®); and certain other related documents and communications. On June 24, 2020, the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S. District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute, and asserting causes of action under the federal False Claims Act and state law (the "June 2020 Civil Complaint"). On August 24, 2020, the Company filed a motion to dismiss the June 2020 Civil Complaint in its entirety. On December 4, 2020, the court denied the motion to dismiss. On December 28, 2022, the U.S. Attorney's Office for the District of Massachusetts filed a motion for partial summary judgment. On January 31, 2023, the Company filed a motion for summary judgment. An oral hearing on the parties' respective motions for summary judgment was held on July 21, 2023. On September 27, 2023, the court (i) denied in part and granted in part the Company's motion for summary judgment and (ii) denied in its entirety the motion for partial summary judgment filed by the U.S. Attorney's Office for the District of Massachusetts. On October 25, 2023, the court certified for interlocutory appeal a portion of the court's September 27, 2023 order that addressed the causation standard applicable to the alleged violations of the federal Anti-Kickback Statute and federal False Claims Act; and on December 11, 2023, the U.S. Court of Appeals for the First Circuit certified for appeal (i.e., accepted for review) the court's September 27, 2023 order.

In September 2019, the Company and Regeneron Healthcare Solutions, Inc., a wholly-owned subsidiary of the Company, each received a civil investigative demand ("CID") from the U.S. Department of Justice pursuant to the federal False Claims Act relating to remuneration paid to physicians in the form of consulting fees, advisory boards, speaker fees, and payment or reimbursement for travel and entertainment allegedly in violation of the federal Anti-Kickback Statute. The CIDs relate to EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present. On

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June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S. LLC by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law. Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case. On October 29, 2021, the qui tam plaintiffs filed an amended complaint in this matter. On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety. On July 25, 2023, the court in part granted and in part denied the Company's motion to dismiss. On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings. A trial has been scheduled for April 2025.

In June 2021, the Company received a CID from the U.S. Department of Justice pursuant to the federal False Claims Act. The CID states that the investigation concerns allegations that the Company (i) violated the False Claims Act by paying kickbacks to distributors and ophthalmology practices to induce purchase of EYLEA, including through discounts, rebates, credit card fees, free units of EYLEA, and inventory management systems; and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to the Centers for Medicare & Medicaid Services. The CID covers the period from January 2011 through June 2021. On November 29, 2023, the U.S. Department of Justice informed the Company that it had filed a notice of partial intervention in this matter. On March 28, 2024, the Department of Justice and the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint intervention in the U.S. District Court for the District of Massachusetts asserting causes of action under the federal False Claims Act and a claim for unjust enrichment. Also on March 28, 2024, the U.S. District Court of the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, and Besse Medical by two qui tam plaintiffs (known as relators) purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute.

California Department of Insurance Subpoena

In September 2022, the Company received a subpoena from the Insurance Commissioner for the State of California pursuant to the California Insurance Code. The subpoena seeks information relating to the marketing, sale, and distribution of EYLEA, including (i) discounts, rebates, credit card fees, and inventory management systems; (ii) Regeneron's relationships with distributors; (iii) price reporting; (iv) speaker programs; and (v) patient support programs. The subpoena covers the period from January 1, 2014 through August 1, 2021. The Company is cooperating with this investigation.

Proceedings Initiated by Other Payors Relating to Patient Assistance Organization Support

The Company is party to several lawsuits relating to the conduct alleged in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above. These lawsuits were filed by UnitedHealthcare Insurance Company and United Healthcare Services, Inc. (collectively, "UHC") and Humana Inc. ("Humana") in the United States District Court for the Southern District of New York on December 17, 2020 and July 22, 2021, respectively; and by Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (collectively, "BCBS"), Medical Mutual of Ohio ("MMO"), Horizon Healthcare Services, Inc. d/b/a Horizon Blue Cross Blue Shield of New Jersey ("Horizon"), and Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund ("Local 464A") in the U.S. District Court for the District of Massachusetts on December 20, 2021, February 23, 2022, April 4, 2022, and June 17, 2022, respectively. These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act and seek monetary damages and equitable relief. The MMO and Local 464A lawsuits are putative class action lawsuits. On December 29, 2021, the lawsuits filed by UHC and Humana were stayed by the United States District Court for the Southern District of New York pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. On September 27, 2022, the lawsuits filed by BCBS, MMO, and Horizon were stayed by the U.S. District Court for the District of Massachusetts pending resolution of the proceedings before the same court concerning the allegations in the June 2020 Civil Complaint; and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter.

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Proceedings Relating to Shareholder Derivative Complaint

On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current and certain former members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the June 2020 Civil Complaint discussed under "Department of Justice Matters" above. The complaint seeks an award of damages allegedly sustained by the Company; an order requiring Regeneron to take all necessary actions to reform and improve its corporate governance and internal procedures; disgorgement from the individual defendants of all profits and benefits obtained by them resulting from their sales of Regeneron stock; and costs and disbursements of the action, including attorneys' fees. On July 28, 2021, the defendants filed a notice of removal, removing the case from the New York Supreme Court to the U.S. District Court for the Southern District of New York. On September 23, 2021, the plaintiff moved to remand the case to the New York Supreme Court. Also on September 23, 2021, the individual defendants moved to dismiss the complaint in its entirety. On December 19, 2022, the U.S. District Court for the Southern District of New York denied the plaintiff's motion to remand the case and granted a motion to stay the case pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts concerning the allegations in the June 2020 Civil Complaint. As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice. The Company can therefore renew the motion to dismiss upon conclusion of the stay.

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Item 2.    Management's Discussion and Analysis of Financial Condition and Results of Operations

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (where applicable, together with its subsidiaries, "Regeneron," "Company," "we," "us," and "our"), 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 nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation those discussed or referenced in this report, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;

•the likelihood and timing of achieving any of our anticipated development milestones referenced in this report;

•safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials;

•the likelihood, timing, and scope of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation those discussed or referenced in this report;

•the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval;

•ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy;

•determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates;

•competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates;

•uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron's Products and Regeneron's Product Candidates;

•our ability to manufacture and manage supply chains for multiple products and product candidates;

•the ability of our 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 Regeneron's Product Candidates;

•the availability and extent of reimbursement of Regeneron's Products from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid;

•coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors;

•unanticipated expenses;

•the costs of developing, producing, and selling products; our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance;

•the potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated;

•the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on our business; and

•risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 11 to our Condensed Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 11 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition. 

These statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements. In evaluating such statements, shareholders and potential investors should specifically consider the various

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factors identified under Part II, Item 1A. "Risk Factors," which could cause actual events and results to differ materially from those indicated by such forward-looking statements. We do not undertake any obligation to update (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events, or otherwise.

Overview

Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.

Our core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities. Our objective is to continue to advance as an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.

Selected financial information is summarized as follows:

	Three Months Ended March 31,
(In millions, except per share data)	2024		2023
Revenues	$	3,145.0	$	3,162.1
Net income	$	722.0	$	817.8
Net income per share - diluted	$	6.27	$	7.17

For purposes of this report, references to our products encompass products marketed or otherwise commercialized by us and/or our collaborators or licensees and references to our product candidates encompass product candidates in development by us and/or our collaborators or licensees (in the case of collaborated or licensed products or product candidates under the terms of the applicable collaboration or license agreements), unless otherwise stated or required by the context.

Products

Products that have received marketing approval are summarized in the table below. Certain products have also received marketing approval in countries outside the United States, European Union ("EU"), or Japan.

Product	Disease	Territory
		U.S.	EU	Japan
EYLEA® HD (aflibercept) Injection 8 mg(a)	Wet age-related macular degeneration ("wAMD")	a	a	a
	Diabetic macular edema ("DME")	a	a	a
	Diabetic retinopathy ("DR")	a
EYLEA® (aflibercept) Injection(a)	wAMD	a	a	a
	DME	a	a	a
	DR	a
	Macular edema following retinal vein occlusion ("RVO"), which includes macular edema following central retinal vein occlusion ("CRVO") and macular edema following branch retinal vein occlusion ("BRVO")	a	a	a
	Myopic choroidal neovascularization ("mCNV")		a	a
	Neovascular glaucoma ("NVG")			a
	Retinopathy of prematurity ("ROP")	a	a	a
Dupixent® (dupilumab) Injection(b)	Atopic dermatitis (in adults, adolescents, and pediatrics aged 6 months and older)	a	a	a
	Asthma (in adults and adolescents)	a	a	a

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Product (continued)	Disease	Territory
		U.S.	EU	Japan
	Asthma (in pediatrics 6–11 years of age)	a	a
	Chronic rhinosinusitis with nasal polyposis ("CRSwNP")	a	a	a
	Eosinophilic esophagitis ("EoE") (in adults and adolescents)	a	a
	EoE (in pediatrics 1–11 years of age)	a
	Prurigo nodularis	a	a	a
	Chronic spontaneous urticaria ("CSU") (in adults and adolescents)			a
Libtayo® (cemiplimab) Injection	Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC")	a	a
	Metastatic or locally advanced first-line NSCLC (in combination with chemotherapy)	a	a
	Metastatic or locally advanced basal cell carcinoma ("BCC")	a	a
	Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC")	a	a
	Metastatic or recurrent second-line cervical cancer		a	a
Praluent® (alirocumab) Injection(c)	LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD")	a	a
	HeFH in pediatrics and adolescents (8–17 years of age)	a	a
	Cardiovascular risk reduction in patients with established cardiovascular disease	a	a
	Homozygous familial hypercholesterolemia ("HoFH")	a
Kevzara (sarilumab) Injection(b)	Rheumatoid arthritis ("RA")	a	a	a
	Polymyalgia rheumatica ("PMR")	a
REGEN-COV®(d)	COVID-19		a	a
Evkeeza® (evinacumab) Injection(e)	HoFH (in adults, adolescents, and pediatrics aged 5 years and older)	a	a	a
Inmazeb® (atoltivimab, maftivimab, and odesivimab) Injection	Infection caused by Zaire ebolavirus	a
Veopoz® (pozelimab) Injection	CD55-deficient protein-losing enteropathy ("CHAPLE") (in adults, adolescents, and pediatrics aged 1 year and older)	a
ARCALYST® (rilonacept) Injection(f)	Cryopyrin-associated periodic syndromes ("CAPS"), including familial cold auto-inflammatory syndrome ("FCAS") and Muckle-Wells syndrome ("MWS") (in adults and adolescents)	a
	Deficiency of interleukin-1 receptor antagonist ("DIRA") (in adults, adolescents, and pediatrics)	a
	Recurrent pericarditis (in adults and adolescents)	a
ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion(g)	Metastatic colorectal cancer ("mCRC")	a	a	a

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Note: Refer to table below (net product sales of Regeneron-discovered products) for information regarding whether net product sales for a particular product are recorded by us or others. In addition, unless otherwise noted, products in the table above are generally approved for use in adults in the above-referenced diseases.

(a) In collaboration with Bayer outside the United States. Aflibercept 8 mg is known as EYLEA HD in the United States and EYLEA 8 mg in other countries.

(b) In collaboration with Sanofi

(c) The Company is solely responsible for the development and commercialization of Praluent in the United States and Sanofi is responsible for the development and commercialization of Praluent outside the United States.

(d) In collaboration with Roche. Product is known as REGEN-COV in the United States and Ronapreve™ in other countries.

(e) The Company is solely responsible for the development and commercialization of Evkeeza in the United States and Ultragenyx is responsible for the development and commercialization of Evkeeza outside the United States.

(f) Kiniksa is solely responsible for the development and commercialization of ARCALYST.

(g) Sanofi is solely responsible for the development and commercialization of ZALTRAP.

Net product sales of Regeneron-discovered products consist of the following:

	Three Months Ended March 31,
	2024						2023						% Change
(In millions)	U.S.		ROW(g)		Total		U.S.		ROW		Total		(Total Sales)
EYLEA HD and EYLEA(a)	$	1,401.6	$	849.4	$	2,251.0	$	1,433.8	$	847.1	$	2,280.9	(1	%)
Dupixent(b)	$	2,218.0	$	858.8	$	3,076.8	$	1,898.1	$	586.9	$	2,485.0	24	%
Libtayo(c)	$	159.2	$	104.7	$	263.9	$	109.7	$	72.9	$	182.6	45	%
Praluent(d)	$	70.0	$	131.3	$	201.3	$	40.2	$	105.7	$	145.9	38	%
Kevzara(b)	$	50.0	$	44.1	$	94.1	$	39.2	$	39.3	$	78.5	20	%
REGEN-COV(e)	$	—	$	1.2	$	1.2	$	—	$	613.2	$	613.2	(100	%)
Other products(f)	$	25.3	$	17.7	$	43.0	$	18.1	$	16.5	$	34.6	24	%
(a) Regeneron records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States.
(b) Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products.
(c) Effective July 1, 2022, the Company began recording net product sales of Libtayo outside the United States and pays Sanofi a royalty on global sales. Included in this line item for the first quarter of 2023 is approximately $6 million of net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period).
(d) Regeneron records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales.
(e) Roche records net product sales outside the United States and the parties share gross profits from sales based on a pre-specified formula.
(f) Included in this line item are products which are sold by the Company and others. Refer to "Results of Operations - Revenues" below for a complete listing of net product sales recorded by the Company. Not included in this line item are net product sales of ARCALYST, which are recorded by Kiniksa; net product sales of ARCALYST were $71 million for the fourth quarter of 2023.
(g) Rest of world ("ROW")

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Programs in Clinical Development

Product candidates in Phase 2 and Phase 3 clinical development, which are being developed by us and/or our collaborators, are summarized in the table below.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development (including any post-approval studies), uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes to drug pricing and reimbursement regulations and requirements, and changes in the competitive landscape affecting a product candidate. The planning, execution, and results of our clinical programs are significant factors that can affect our operating and financial results.

Refer to Part II, Item 1A. "Risk Factors" for a description of risks and uncertainties that may affect our clinical programs. Any of such risks and uncertainties may, among other matters, negatively impact the development timelines set forth in the table below.

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Clinical Program	Phase 2	Phase 3	Regulatory Review(h)	2024 Events to Date	Select Upcoming Milestones
Ophthalmology
EYLEA HD (aflibercept) 8 mg(a)		–RVO		–Approved by European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") for wAMD and DME	–Initiate Phase 3 study in RVO (mid-2024) to enable U.S. Food and Drug Administration ("FDA") submission –Submit supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (mid-2024)
Pozelimab(f) (REGN3918) Antibody to C5					–Initiate Phase 3 study in combination with cemdisiran in geographic atrophy (second half 2024)
Immunology & Inflammation
Dupixent (dupilumab)(b) Antibody to IL-4R alpha subunit	–Ulcerative colitis –Eosinophilic gastroenteritis (Phase 2/3)	–Asthma in pediatrics (2–5 years of age) –Chronic obstructive pulmonary disease ("COPD")(d) –Bullous pemphigoid(c) –CSU –Chronic pruritus of unknown origin	–EoE in pediatrics (1–11 years of age) (EU) –COPD with type 2 inflammatory phenotype (U.S., EU, and Japan) –CSU in adults and adolescents (EU)	–Approved by FDA for EoE in pediatrics (1–11 years of age) –Approved by MHLW for CSU in adults and adolescents	–EC decision on regulatory submission for EoE in pediatrics (second half 2024) –FDA decision on sBLA (target action date of June 27, 2024) and EC decision on regulatory submission (second half 2024) for COPD with type 2 inflammatory phenotype –EC decision on regulatory submission for CSU in adults and adolescents (first half 2025) –Report results from ongoing Phase 3 trial in CSU (in biologic-naïve patients) (fourth quarter 2024) –Report results from Phase 3 trial in bullous pemphigoid (second half 2024)

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Clinical Program (continued)	Phase 2	Phase 3	Regulatory Review(h)	2024 Events to Date	Select Upcoming Milestones
Kevzara (sarilumab)(b) Antibody to IL-6R	–Polyarticular-course juvenile idiopathic arthritis ("pcJIA") (pivotal study) –Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study)		–PMR (EU) –pcJIA (U.S. and EU)		–EC decision on regulatory submission for PMR (second half 2024) –FDA decision on sBLA (target action date of June 10, 2024) and EC decision (second half 2024) on regulatory submission for pcJIA
Itepekimab(b) (REGN3500) Antibody to IL-33	–Non-cystic fibrosis bronchiectasis ("NCFB")	–COPD(e)			–Report results from Phase 3 study in COPD (2025)
REGN5713-5714-5715 Multi-antibody therapy to Bet v 1		–Birch allergy
Solid Organ Oncology
Libtayo (cemiplimab)(g) Antibody to PD-1	–Neoadjuvant CSCC –First-line NSCLC, BNT116(i) combination –Neoadjuvant hepatocellular carcinoma ("HCC")	–Adjuvant CSCC			–Conduct interim analysis from Phase 3 study in adjuvant CSCC (second half 2024)
Fianlimab(f) (REGN3767) Antibody to LAG-3	–First-line advanced NSCLC (Phase 2/3) (pivotal study)	–First-line metastatic melanoma(e) –First-line adjuvant melanoma			–Initiate potentially pivotal Phase 2 study (in combination with Libtayo) in perioperative melanoma (first half 2024) –Initiate Phase 2 study (in combination with Libtayo) in perioperative NSCLC (first half 2024) –Initiate Phase 2 study (in combination with Libtayo) in perioperative head and neck squamous cell carcinoma (2025) –Initiate Phase 3 study (in combination with Libtayo) in first-line metastatic melanoma versus the combination of relatlimab and nivolumab (second half 2024)

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