What changed in this filing

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Item 9A. Controls and Procedures

2023-02-06 compared with 2022-02-07 · 536 added, 570 removed, 1156 unchanged (49% of the section changed)

1 unchanged sentence

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act")), as of the end of the period covered by this Annual Report on Form 10-K.

Our management, with the participation of our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act")), as of the end of the period covered by this Annual Report on Form 10-K.

Based on this evaluation, our principal executive officer and principal financial officer each concluded that, as of the end of such period, our disclosure controls and procedures were effective in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported on a timely basis, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosures.

Management's Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) or 15d-15(f) under the Exchange Act.

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2022 using the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

4 unchanged sentences

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) or 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

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We have adopted a code of business conduct and ethics that applies to our officers, directors, and employees.

The full text of our code of business conduct and ethics can be found on our website (http://www.regeneron.com) under the "Corporate Governance" heading on the "Investors & Media" page.

The full text of our code of business conduct and ethics can be found on our website (http://www.regeneron.com) under the "Governance" heading on the "Investors & Media" page.

We may satisfy the disclosure requirements under Item 5.05 of Form 8-K regarding an amendment to, or a waiver from, a provision of our code of business conduct and ethics that applies to our principal executive officer, principal financial officer, principal accounting officer, or controller, or persons performing similar functions, by posting such information on our website where it is accessible through the same link noted above.

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(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2009, filed April 30, 2009.)

10.1.2 + Form of option agreement and related notice of grant for use in connection with the grant of performance based vesting stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc.

Second Amended and Restated 2000 Long-Term Incentive Plan.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2009, filed April 30, 2009.)

10.1.3 + Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc.

Second Amended and Restated 2000 Long-Term Incentive Plan (revised).

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2010, filed February 17, 2011.)

10.1.4 + Form of option agreement and related notice of grant for use in connection with the grant of performance based vesting stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc.

Second Amended and Restated 2000 Long-Term Incentive Plan (revised).

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2010, filed February 17, 2011.)

10.1.2 + Form of option agreement and related notice of grant for use in connection with the grant of time based vesting stock options to the Registrant's non-employee directors under the Regeneron Pharmaceuticals, Inc.

135 unchanged sentences

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2009, filed August 4, 2009.)

10.10* Amended and Restated Collaboration Agreement, dated as of February 23, 2015, by and between Sanofi-Aventis US LLC and the Registrant.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2015, filed May 7, 2015.)

10.10* License and Collaboration Agreement, dated as of October 18, 2006, by and between Bayer HealthCare LLC and the Registrant.

4 unchanged sentences

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)

10.12 License and Collaboration Agreement, dated as of January 10, 2014, by and between Bayer HealthCare LLC and the Registrant.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2014, filed May 8, 2014.)

10.13* Amended and Restated Discovery and Preclinical Development Agreement, dated as of November 10, 2009, by and between Aventis Pharmaceuticals Inc.

and the Registrant.

(Incorporated by reference from the Form 10-K/A for the Registrant, for the year ended December 31, 2009, filed June 2, 2010.)

10.13.1* Amendment No.

1 to Amended and Restated Discovery and Preclinical Development Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)

10.11* Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009, by and among Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant.

8 unchanged sentences

10.11.4** Fourth Amendment to Amended and Restated License and Collaboration Agreement, dated as of October 6, 2021, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2021, filed February 7, 2022.)

10.11.5** Fifth Amendment to Amended and Restated License and Collaboration Agreement, dated as of June 1, 2022, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2022, filed August 3, 2022.)

10.12** Praluent Cross License & Commercialization Agreement, dated as of April 5, 2020, and effective as of April 1, 2020, by and between the Registrant and Sanofi Biotechnology SAS.

4 unchanged sentences

(Incorporated by reference from the Form 8-K for the Registrant, filed May 29, 2020.)

10.17* Letter Agreement by and between the Registrant and Aventis Pharmaceuticals Inc., dated May 2, 2013.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)

10.18 Credit Agreement, dated as of December 14, 2018, by and among the Registrant, as a borrower and guarantor;

certain direct subsidiaries of the Registrant, as the initial subsidiary borrowers;

JPMorgan Chase Bank, N.A., as administrative agent;

Bank of America, N.A.

Bank National Association, as co-syndication agents;

Barclays Bank PLC, Citibank, N.A., Fifth Third Bank, and MUFG Bank, Ltd., as co-documentation agents;

JPMorgan Chase Bank, N.A., Bank of America, N.A., and U.S.

Bank National Association, as the issuing banks;

JPMorgan Chase Bank, N.A., as the swingline lender;

and the other lenders party thereto from time to time.

10.14*** Credit Agreement, dated as of December 19, 2022, by and among the Registrant, as a borrower and guarantor, certain direct subsidiaries of the Registrant, as the initial subsidiary borrowers, the lenders and issuing banks party thereto, and JPMorgan Chase Bank, N.A., as administrative agent, swingline lender, and an issuing bank.

(Incorporated by reference from the Form 8-K for the Registrant, filed December 20, 2022.)

10.18.1 Amendment No.

1 to Credit Agreement, dated as of November 11, 2021, by and among the Registrant, as a borrower and guarantor;

certain direct subsidiaries of the Registrant, as subsidiary borrowers;

JPMorgan Chase Bank, N.A., as administrative agent;

and the lenders party thereto.

10.19* Amended and Restated Immuno-oncology Discovery and Development Agreement, executed on January 2, 2019 and effective as of December 31, 2018, by and between the Registrant and Sanofi Biotechnology SAS.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019).

10.20* Immuno-oncology License and Collaboration Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)

10.20.1** First Amendment to Immuno-oncology License and Collaboration Agreement, dated as of October 6, 2021, by and between the Registrant and Sanofi Biotechnology SAS.

10.21* Collaboration Agreement, dated as of September 29, 2015, by and between Regeneron Ireland and Mitsubishi Tanabe Pharma Corporation.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)

10.15** Amended and Restated Immuno-oncology License and Collaboration Agreement, dated as of June 1, 2022, by and between the Registrant and Sanofi Biotechnology SAS.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2022, filed August 3, 2022.)

10.16* ANG2 License and Collaboration Agreement, dated as of March 23, 2016, by and between Bayer HealthCare LLC and the Registrant.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2016, filed May 5, 2016.)

10.23* Collaboration Agreement, dated as of September 17, 2016, by and between Teva Pharmaceuticals International GmbH and Regeneron Ireland.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2016, filed November 4, 2016.)

10.17* Purchase Agreement, dated as of December 30, 2016, by and among BMR-Landmark at Eastview LLC and BMR-Landmark at Eastview IV LLC and the Registrant.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2016, filed February 9, 2017.)

10.25 Amended and Restated Participation Agreement, dated as of May 2, 2019, by and among Old Saw Mill Holdings LLC, as lessee;

Bank of America, N.A., as administrative agent;

BA Leasing BSC, LLC, as lessor;

and the lenders party thereto from time to time.

(Incorporated by reference from the Form 8-K for the Registrant, filed May 3, 2019.)

10.25.1 First Amendment to Amended and Restated Participation Agreement, dated as of October 6, 2021, by and among Old Saw Mill Holdings LLC, as lessee;

the Registrant, as parent guarantor;

certain subsidiaries of the Registrant, as subsidiary guarantors;

BA Leasing BSC, LLC, as lessor;

Bank of America, N.A., as administrative agent;

and the lenders party thereto.

10.26 Amended and Restated Lease and Remedies Agreement, dated as of May 2, 2019, between Old Saw Mill Holdings LLC, as lessee, and BA Leasing BSC, LLC, as lessor.

(Incorporated by reference from the Form 8-K for the Registrant, filed May 3, 2019.)

10.27 Amended and Restated Guaranty, dated as of May 2, 2019, made by Regeneron Pharmaceuticals, Inc., Regeneron Healthcare Solutions, Inc., and Regeneron Genetics Center LLC, as guarantors.

(Incorporated by reference from the Form 8-K for the Registrant, filed May 3, 2019.)

10.28 Letter Agreement, dated as of January 7, 2018, by and among the Registrant, Sanofi, sanofi-aventis US LLC, Aventis Pharmaceuticals Inc., sanofi-aventis Amérique du Nord, and Sanofi Biotechnology SAS.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2018, filed May 3, 2018.)

10.18*** Second Amended and Restated Participation Agreement, dated as of March 2, 2022, by and among Old Saw Mill Holdings LLC, as lessee, Bank of America, N.A., as administrative agent, BA Leasing BSC, LLC, as lessor, and the rent assignees party thereto from time to time.

(Incorporated by reference from the Form 8-K for the Registrant, filed March 8, 2022.)

10.19*** Second Amended and Restated Lease and Remedies Agreement, dated as of March 2, 2022, between Old Saw Mill Holdings LLC, as lessee, and BA Leasing BSC, LLC, as lessor.

(Incorporated by reference from the Form 8-K for the Registrant, filed March 8, 2022.)

10.20*** Second Amended and Restated Guaranty, dated as of March 2, 2022, made by the Registrant, Regeneron Healthcare Solutions, Inc., and Regeneron Genetics Center LLC, as guarantors.

(Incorporated by reference from the Form 8-K for the Registrant, filed March 8, 2022.)

10.21** Master Agreement, dated as of April 8, 2019, by and between the Registrant and Alnylam Pharmaceuticals, Inc.

2 unchanged sentences

10.21.2** Form of License Agreement (Exhibit C to Master Agreement contained in Exhibit 10.

10.30** Investor Agreement, dated as of April 8, 2019, by and between the Registrant and Alnylam Pharmaceuticals, Inc.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2019, filed August 6, 2019.)

10.31 Stock Purchase Agreement, dated as of April 8, 2019, by and between the Registrant and Alnylam Pharmaceuticals, Inc.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2019, filed August 6, 2019.)

10.32 Stock Repurchase Agreement, dated as of May 25, 2020, by and between the Registrant and Sanofi.

(Incorporated by reference from the Form 8-K for the Registrant, filed May 29, 2020.)

10.33** Base Agreement, dated as of July 6, 2020, by and between the Registrant and Advanced Technology International.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2020, filed November 5, 2020.)

10.34** Project Agreement, dated as of July 6, 2020, by and between the Registrant and Advanced Technology International.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)

10.34.1 Modification No.

01 to Project Agreement, dated as of October 13, 2020, by and between the Registrant and Advanced Technology International.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)

10.34.2** Modification No.

02 to Project Agreement, dated as of November 17, 2020, by and between the Registrant and Advanced Technology International.

(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)

10.22** License Agreement, dated as of August 18, 2020, by and among the Registrant, F.

1 unchanged sentence

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2020, filed November 5, 2020.)

10.36** Supply Agreement, dated as of January 12, 2021, by and between the Registrant and the U.S.

Army Contracting Command, New Jersey.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2021, filed May 6, 2021.)

10.36.1** Modification P00004 to Supply Agreement, dated as of July 26, 2021, by and between the Registrant and the U.S.

Army Contracting Command, New Jersey.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2021, filed November 4, 2021.)

10.36.2** Modification P00005 to Supply Agreement, dated as of September 14, 2021, by and between the Registrant and the U.S.

Army Contracting Command, New Jersey.

(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2021, filed November 4, 2021.)

21.1 Subsidiaries of the Registrant.

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104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

* Portions of this document have been omitted and filed separately with the Commission pursuant to requests for confidential treatment pursuant to Rule 24b-2

* Portions of this document have been omitted and filed separately with the Securities and Exchange Commission pursuant to requests for confidential treatment pursuant to Rule 24b-2.

** Certain confidential portions of this Exhibit were omitted in accordance with Item 601(b)(10) of Regulation S-K.

The Registrant agrees to furnish supplementally a copy of all confidential portions of this Exhibit that were omitted to the Securities and Exchange Commission upon its request.

*** Certain of the exhibits and/or schedules to this Exhibit have been omitted in accordance with Item 601(a)(5) of Regulation S-K.

The Registrant agrees to furnish supplementally a copy of all omitted exhibits and schedules of this Exhibit to the Securities and Exchange Commission upon its request.

+ Indicates a management contract or compensatory plan or arrangement.

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Marc Tessier-Lavigne, Ph.D.

THOMPSON Director February 6, 2023

Thompson, M.D.

ZOGHBI Director February 6, 2023

39 unchanged sentences

The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Accounting for Other Operating Income related to Research and Development Up-front and Milestone Payments

As described in Note 1 to the consolidated financial statements, other operating income related to collaboration arrangements where the Company satisfies obligations during the development phase over time is typically recognized using an input method on the basis of research and development costs incurred relative to the total expected costs which determines the extent of progress towards completion of the obligation.

Other operating income for non-refundable up-front payments and development milestones for which management used an input method, was $42.5 million for the year ended December 31, 2021.

As of December 31, 2021, $ 322.5 million was included in other liabilities representing the amount of previously deferred non-refundable up-front and development milestones expected to be recognized in other operating income over time.

Management has disclosed that there is variability in the scope of activities and length of time necessary to develop a drug product, potential delays in development programs, changes to development plans and budgets as programs progress, and uncertainty in the ultimate requirements to obtain governmental approval for commercialization related to these estimates.

The principal considerations for our determination that performing procedures relating to the accounting for other operating income related to research and development up-front and milestone payments is a critical audit matter are the significant judgment by management when determining the estimate of total expected research and development costs to complete the obligation, which in turn led to a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating evidence to assess the reasonableness of the estimates of the costs to complete.

Accounting for the Acquisition of the Worldwide Rights to Libtayo

As described in Notes 1, 3, and 8 to the consolidated financial statements, in July 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi.

The transaction was accounted for as an asset acquisition.

Amounts paid in connection with obtaining the worldwide rights to Libtayo, which included an up-front payment of $ 900 million, offset by the remaining up-front payments of $ 241 million previously received under the Immuno-oncology License and Collaboration Agreement, were recorded as an intangible asset.

The Company recorded additions to the Libtayo intangible asset primarily related to contingent consideration due to Sanofi in connection with obtaining the worldwide rights to Libtayo.

As disclosed by management, due to the complexity of the terms of the amendments to the collaboration agreements in contemplation of the acquisition of the worldwide rights to Libtayo, significant judgment was applied by management in identifying the elements of the transaction and evaluating the timing and recognition of contingent consideration including the following:

royalties, which are recorded in the period in which the underlying sales occur;

sales-based milestones up to an aggregate of $ 100 million, which are recorded when the milestone is deemed probable by the Company of being achieved;

a regulatory milestone of $ 100 million, which is recorded upon achievement;

and a portion of the value associated with the increase in the reimbursement percentage pursuant to the amendment to the Company's Antibody License and Collaboration Agreement.

The principal considerations for our determination that performing procedures relating to the accounting for the acquisition of the worldwide rights to Libtayo is a critical audit matter are (i) the significant judgment by management in identifying the elements of the transaction and in evaluating the timing and recognition of contingent consideration, (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating audit evidence related to the accounting for the transaction and related disclosures, and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements.

These procedures included testing the effectiveness of controls relating to the accounting for other operating income related to research and development up-front and milestone payments, including controls over the determination of the estimate of total expected research and development costs to complete the obligation.

These procedures also included, among others, evaluating and testing management’s process for determining the estimate of total expected research and development costs at completion for a sample of contracts, which included evaluating the reasonableness of actual costs incurred and estimated costs to complete.

Evaluating the reasonableness of estimated costs to complete involved assessing management’s ability to reasonably estimate costs to complete the obligation by (i) obtaining supporting evidence for expected development activities;

(ii) evaluating the identification of circumstances that may warrant a modification to estimated costs to complete;

and (iii) agreeing estimates of total budgeted costs to contracts or other agreements with collaboration partners.

These procedures included testing the effectiveness of controls over management's accounting for the amendments to the collaboration agreements including controls over the identification of the elements of the transaction and evaluating the timing and recognition of contingent consideration.

These procedures also included, among others (i) reviewing the Amended and Restated Immuno-oncology License and Collaboration Agreement and the amended Antibody License and Collaboration Agreement and other agreements related to the transaction;

(ii) evaluating management's identification of the elements of the transaction;

and (iii) evaluating the timing and recognition of contingent consideration.

Professionals with specialized skill and knowledge were used to assist in evaluating the identification of the elements of the transaction.

/s/ PricewaterhouseCoopers LLP

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CONSOLIDATED BALANCE SHEETS

(In millions, except share data)

(In millions, except per share data)

Current assets:

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Property, plant, and equipment, net 3,763.0 3,482.2

Intangible assets, net 915.5 6.7

Deferred tax assets 1,723.7 876.9

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Stockholders' equity:

Preferred Stock, $ .01 par value;

Preferred Stock, par value $ .01 per share;

30.0 shares authorized;

issued and outstanding - none

Class A Stock, convertible, $ .001 par value;

Class A Stock, convertible, par value $ .001 per share;

40.0 shares authorized;

shares issued and outstanding - 1,823,283 in 2021 and 1,848,970 in 2020

Common Stock, $ .001 par value;

shares issued and outstanding - 1.8 in 2022 and 2021

Common Stock, par value $ .001 per share;

320.0 shares authorized;

2 unchanged sentences

Retained earnings 23,306.7 18,968.3

Accumulated other comprehensive (loss) income ( 26.2 ) 29.3

Accumulated other comprehensive loss ( 238.8 ) ( 26.2 )

Treasury Stock, at cost;

16 unchanged sentences

Research and development 3,592.5 2,860.1 2,647.0

Acquired in-process research and development 255.1 48.0 88.0

Selling, general, and administrative 2,115.9 1,824.9 1,346.0

33 unchanged sentences

Repurchases of Common Stock — — — — — — — ( 11.6 ) ( 5,880.9 ) ( 5,880.9 )

Conversion of Class A Stock to Common Stock ( 0.1 ) — 0.1 — — — — — — —

Stock-based compensation charges — — — — 442.9 — — — — 442.9

Adjustment upon adoption of new accounting standard — — — — — 9.7 — — — 9.7

Net income — — — — — 3,513.2 — — — 3,513.2

7 unchanged sentences

Net income — — — — — 8,075.3 — — — 8,075.3

Other comprehensive income, net of tax — — — — — — 8.2 — — 8.2

Other comprehensive loss, net of tax — — — — — — ( 55.5 ) — — ( 55.5 )

Balance, December 31, 2021 1.8 — 126.2 0.1 8,087.5 18,968.3 ( 26.2 ) ( 19.4 ) ( 8,260.9 ) 18,768.8

20 unchanged sentences

Depreciation and amortization 341.4 286.2 235.9

Non-cash compensation expense 601.7 432.0 464.3

Gains on marketable and other securities, net ( 387.0 ) ( 221.8 ) ( 131.5 )

Stock-based compensation expense 725.0 601.7 432.0

Losses (gains) on marketable and other securities, net 36.8 ( 387.0 ) ( 221.8 )

Other non-cash items, net 368.0 568.7 86.8

Deferred taxes ( 147.1 ) 75.6 ( 130.6 )

Deferred income taxes ( 746.4 ) ( 147.1 ) 75.6

Acquired in-process research and development in connection with asset acquisition 195.0 — —

Changes in assets and liabilities:

Increase in accounts receivable ( 1,927.4 ) ( 1,356.1 ) ( 523.7 )

Decrease (increase) in accounts receivable 707.8 ( 1,927.4 ) ( 1,356.1 )

Increase in inventories ( 696.5 ) ( 494.3 ) ( 529.4 )

(Increase) decrease in prepaid expenses and other assets ( 148.6 ) ( 240.7 ) 114.9

(Decrease) increase in deferred revenue ( 120.2 ) 148.1 139.5

Increase in accounts payable, accrued expenses, and other liabilities 866.1 118.9 599.0

Increase (decrease) in deferred revenue 32.4 ( 120.2 ) 148.1

(Decrease) increase in accounts payable, accrued expenses, and other liabilities ( 138.4 ) 866.1 118.9

Total adjustments 676.5 ( 994.0 ) ( 895.1 )

4 unchanged sentences

Capital expenditures ( 590.1 ) ( 551.9 ) ( 614.6 )

Payments for Libtayo intangible asset ( 1,026.8 ) — —

Asset acquisition, net of cash acquired ( 230.3 ) — —

Net cash used in investing activities ( 3,784.6 ) ( 5,384.7 ) ( 70.6 )

21 unchanged sentences

and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for serious diseases.

Our commercialized medicines and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases, and rare diseases.

We currently have nine products that have received marketing approval by the U.S.

Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases, and rare diseases.

The Company currently has nine products that have received marketing approval by the U.S.

Food and Drug Administration ("FDA").

In addition, REGEN-COV ® has not been approved by the FDA, but has been authorized under an Emergency Use Authorization ("EUA") (see Note 3 and Note 6 for additional information).

In addition, REGEN-COV ® was authorized under an Emergency Use Authorization ("EUA") from November 2020 until January 2022 when the EUA was revised to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment;

with this EUA revision, REGEN-COV is not currently authorized for use in any U.S.

states, territories, or jurisdictions.

The Company is a party to collaboration agreements to develop and commercialize, as applicable, certain products and product candidates (see Note 3).

4 unchanged sentences

Intercompany balances and transactions are eliminated in consolidation.

Certain reclassifications have been made to prior period amounts to conform with the current period's presentation.

Beginning with the first quarter of 2022, the Company added a new line item, Acquired in-process research and development, to its Consolidated Statements of Operations and Comprehensive Income.

This line item includes in-process research and development acquired in connection with asset acquisitions as well as up-front/opt-in payments related to license and collaboration agreements.

Amounts recorded in this line item during the year ended December 31, 2022 would have historically been recorded to Research and development expenses.

Certain reclassifications have been made to prior period amounts to conform with the current period's presentation, including in connection with the addition of Acquired in-process research and development described above.

Use of Estimates

1 unchanged sentence

Actual results could differ from those estimates.

The extent to which the COVID-19 pandemic may directly or indirectly impact our business, financial condition, and results of operations is highly uncertain and subject to change.

We considered the potential impact of the COVID-19 pandemic on our estimates and assumptions and, other than the inventory write-offs and reserves recorded related to REGEN-COV (see Note 6), there was not a material impact to our consolidated financial statements as of and for the year ended December 31, 2021;

however, actual results could differ from those estimates and there may be changes to our estimates in future periods.

Concentration of Credit Risk

2 unchanged sentences

Concentrations of credit risk with respect to customer and collaborator accounts receivable are significant.

As of December 31, 2021, three individual customers accounted for 91 % (including 29 % related to the U.S.

government) of the Company's net trade accounts receivable balances.

Three individual customers accounted for 93 % of the Company's net trade accounts receivable balances as of December 31, 2020.

As of December 31, 2022, two individual customers accounted for 86 % of the Company's net trade accounts receivable balances.

Three individual customers accounted for 91 % (including 29 % related to the U.S.

government) of the Company's net trade accounts receivable balances as of December 31, 2021.

The Company has contractual payment terms with each of its collaborators and customers, and the Company monitors their financial performance and credit worthiness so that it can properly assess and respond to any changes in their credit profile.

As of December 31, 2021 and 2020, there were no write-offs and allowances of accounts receivable related to credit risk for our collaborators or customers.

As of December 31, 2022 and 2021, there were no write-offs and allowances of accounts receivable related to credit risk for the Company's collaborators or customers.

Significant Accounting Policies

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The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and diversification.

We invest our cash primarily in debt securities.

We consider our investments in debt securities to be "available-for-sale," as defined by authoritative guidance issued by the Financial Accounting Standards Board ("FASB").

The Company invests its cash primarily in debt securities.

The Company considers its investments in debt securities to be "available-for-sale," as defined by authoritative guidance issued by the Financial Accounting Standards Board ("FASB").

These assets are carried at fair value and the unrealized gains and losses are included in accumulated other comprehensive income (loss).

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If the decline in fair value is due to credit-related factors, a loss is recognized in net income, whereas if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss).

We also have investments in equity securities that are carried at fair value with changes in fair value recognized within other income (expense), net.

We have elected to measure certain equity investments we hold that do not have readily determinable fair values at cost less impairment, if any, and adjust for observable price changes in orderly transactions for identical or similar investments of the same issuer within other income (expense), net.

The Company also has investments in equity securities that are carried at fair value with changes in fair value recognized within other income (expense), net.

The Company has elected to measure certain equity investments it holds that do not have readily determinable fair values at cost less impairment, if any, and adjusts for observable price changes in orderly transactions for identical or similar investments of the same issuer within other income (expense), net.

Accounts Receivable

The Company's trade accounts receivable arise from product sales and represent amounts due from its customers, which are all located in the United States.

The Company's trade accounts receivable arise from product sales and represent amounts due from its customers.

In addition, the Company records accounts receivable arising from its collaboration and licensing agreements.

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Expenditures for maintenance and repairs which do not materially extend the useful lives of the assets are charged to expense as incurred.

The cost and accumulated depreciation or amortization of assets retired or sold are removed from the respective accounts, and any gain or loss is recognized in income (loss) from operations.

The cost and accumulated depreciation or amortization of assets retired or sold are removed from the respective accounts, and any gain or loss is recognized within income from operations.

The estimated useful lives of property, plant, and equipment are as follows:

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The Company accounts for lease components (e.g., rental payments) separately from non-lease components (e.g., common area maintenance costs).

Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term, unless there is a transfer of title or purchase option we are reasonably certain to exercise.

For leases where an implicit rate is not readily determinable, we use our incremental borrowing rate based on information available at the lease commencement date to determine the present value of future lease payments.

For leases where an implicit rate is not readily determinable, the Company uses its incremental borrowing rate based on information available at the lease commencement date to determine the present value of future lease payments.

Lease expense for operating leases is recognized on a straight-line basis over the expected lease term.

Intangible Assets

The Company makes a determination of whether an asset or set of assets acquired constitute a business.

If it is determined that substantially all of the fair value of gross assets acquired in a transaction are concentrated in a single identifiable asset, then the transaction is accounted for as an asset acquisition.

Intangible assets acquired in connection with an asset acquisition are recorded at cost.

Such amounts may include up-front payments and contingent consideration.

With regard to contingent consideration, the Company recognizes regulatory milestones upon achievement, royalties in the period in which the underlying sales occur, and sales-based milestones when the milestone is deemed probable by the Company of being achieved.

Intangible assets are amortized to Cost of goods sold over the estimated useful lives of the assets based on the pattern in which the economic benefits of the intangible assets are consumed;

if that pattern cannot be reliably determined, a straight-line basis is used.

If contingent consideration is recognized subsequent to the acquisition date in an asset acquisition, the amount of such consideration is recorded as an addition to the cost basis of the intangible asset with a cumulative catch-up adjustment for amortization expense as if the additional amount of consideration had been accrued from the outset of the acquisition.

The Company's intangible assets are reviewed for recoverability whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable.

If an indicator of impairment exists, the Company compares the projected undiscounted cash flows to be generated by the asset to the intangible asset's carrying amount.

If the projected undiscounted cash flows of the intangible asset are less than the carrying amount, the intangible asset is written down to its fair value in the period in which the impairment occurs.

Revenue Recognition - Product Revenue

Revenue from product sales is recognized at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt or acceptance by our customer.

The amount of revenue we recognize from product sales may vary due to rebates, chargebacks, and discounts provided under governmental and other programs, distribution-related fees, and other sales-related deductions.

In order to determine the transaction price, we estimate, utilizing the expected value method, the amount of variable consideration to which we will be entitled.

Revenue from product sales is recognized at a point in time when the Company's customer is deemed to have obtained control of the product, which generally occurs upon receipt or acceptance by its customer.

The amount of revenue the Company recognizes from product sales may vary due to rebates, chargebacks, and discounts provided under governmental and other programs, distribution-related fees, and other sales-related deductions.

In order to determine the transaction price, the Company estimates, utilizing the expected value method, the amount of variable consideration to which the Company will be entitled.

This estimate is based upon contracts with customers, healthcare providers, payors, and government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience, estimated payor mix, and other relevant factors.

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The Company estimates reductions to product sales for each type of chargeback and records an allowance for chargebacks in the same period that the related product sales are recognized.

The Company's reserve for chargebacks consists of amounts for which we expect to issue credit based on expected sales by our customers to qualified healthcare providers and chargebacks that customers have claimed but for which we have not yet issued credit.

The Company's reserve for chargebacks consists of amounts for which it expects to issue credit based on expected sales by its customers to qualified healthcare providers and chargebacks that customers have claimed but for which the Company has not yet issued credit.

• Distribution-Related Fees:

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The Company estimates and records other sales-related deductions generally based on gross sales, written contracts, and other relevant factors.

Consistent with industry practice, the Company offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the product's expiration date.

Consistent with industry practice, the Company generally offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the product's expiration date.

Product returned is generally not resalable given the nature of the Company's products and method of administration.

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Collaborative Arrangements

We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize products and/or product candidates.

The Company has entered into various collaborative arrangements to research, develop, manufacture, and commercialize products and/or product candidates.

Although each of these arrangements is unique in nature, such arrangements involve a joint operating activity where both parties are active participants in the activities of the collaboration and exposed to significant risks and rewards dependent on the commercial success of the activities.

In arrangements where we do not deem our collaborator to be our customer, payments to and from our collaborator are presented in our statement of operations based on the nature of our business operations, the nature of the arrangement, including the contractual terms, and the nature of the payments, as summarized in the table and further described below.

In arrangements where the Company does not deem its collaborator to be its customer, payments to and from its collaborator are presented in the Company's statement of operations based on the nature of our business operations, the nature of the arrangement, including the contractual terms, and the nature of the payments, as summarized in the table and further described below.

Nature/Type of Payment Statement of Operations Presentation

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Research and development expense

Up-front and development milestone payments to collaborators Research and development expense

Up-front/opt-in and development milestone payments to collaborators Acquired in-process research and development expense

Reimbursement of Regeneron's commercialization-related expenses

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Cost of goods sold

Up-front and development milestones earned (when we have a combined unit of account which includes a license and providing research and development services)

Other operating income

In agreements involving multiple goods or services promised to be transferred to our collaborator, we must assess, at the inception of the contract, whether each promise represents a separate obligation (i.e., is "distinct"), or whether such promises should be combined as a single unit of account.

When we have a combined unit of account which includes a license and providing research and development services to our collaborator, recognition of up-front payments and development milestones earned from our collaborator is deferred (as a liability) and recognized over the development period (i.e., over time).

In arrangements where we satisfy our obligation(s) during the development phase over time, we recognize amounts initially deferred over time typically using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion.

We review our estimates each period and make revisions to such estimates as necessary.

We recognized other operating income in connection with non-refundable up-front and development milestones previously received, for which we used an input method, of $ 42.5 million and $ 276.7 million for the years ended December 31, 2021 and 2020, respectively.

When we are entitled to reimbursement of all or a portion of the expenses (e.g., research and development expenses) that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.

If our collaborator performs research and development work or commercialization-related activities and share costs, we also recognize, as expense (e.g., research and development expense or selling, general, and administrative expense, as applicable) in the period when our collaborator incurs such expenses, the portion of the collaborator's expenses that we are obligated to reimburse.

Our collaborators provide us with estimated expenses for the most recent fiscal quarter.

Up-front and development milestones earned (when there is a combined unit of account which includes a license and providing research and development services) Other operating income

In agreements involving multiple goods or services promised to be transferred to the Company's collaborator, the Company must assess, at the inception of the contract, whether each promise represents a separate obligation (i.e., is "distinct"), or whether such

promises should be combined as a single unit of account.

When the Company has a combined unit of account which includes a license and providing research and development services to its collaborator, recognition of up-front payments and development milestones earned from its collaborator is deferred (as a liability) and recognized over the development period (i.e., over time) typically using an input method on the basis of the Company's research and development costs incurred relative to the total expected cost which determines the extent of the Company's progress toward completion.

The Company reviews its estimates each period and makes revisions to such estimates as necessary.

When the Company is entitled to reimbursement of all or a portion of the expenses (e.g., research and development expenses) that it incurs under a collaboration, it records those reimbursable amounts in the period in which such costs are incurred.

If the Company's collaborator performs research and development work or commercialization-related activities and the parties share the related costs, the Company also recognizes, as expense (e.g., research and development expense or selling, general, and administrative expense, as applicable) in the period when its collaborator incurs such expenses, the portion of the collaborator's expenses that the Company is obligated to reimburse.

The Company's collaborators provide the Company with estimated expenses for the most recent fiscal quarter.

The estimates are revised, if necessary, in subsequent periods if actual expenses differ from those estimates.

Under certain of the Company's collaboration agreements, product sales and cost of sales may be recorded by the Company's collaborators as they are deemed to be the principal in the transaction.

In arrangements where we:

• supply commercial product to our collaborator, we may be reimbursed for our manufacturing costs as commercial product is shipped to the collaborator;

however, recognition of such cost reimbursements may be deferred until the product is sold by our collaborator to third-party customers;

• share in any profits or losses arising from the commercialization of such products, we record our share of the variable consideration, representing net product sales less cost of goods sold and shared commercialization and other expenses, in the period in which such underlying sales occur and costs are incurred by the collaborator;

• receive royalties and/or sales-based milestone payments from our collaborator, we recognize such amounts in the period earned.

Our collaborators provide us with estimates of product sales and our share of profits or losses, as applicable, for each quarter.

The estimates are revised, if necessary, in subsequent periods if our actual share of profits or losses differ from those estimates.

In arrangements where the Company:

• supplies commercial product to its collaborator, the Company may be reimbursed for its manufacturing costs as commercial product is shipped to the collaborator (however, recognition of such cost reimbursements may be deferred until the product is sold by the Company's collaborator to third-party customers);

• shares in any profits or losses arising from the commercialization of such products, the Company records its share of the variable consideration, representing net product sales less cost of goods sold and shared commercialization and other expenses, in the period in which such underlying sales occur and costs are incurred by the collaborator;

• receives royalties and/or sales-based milestone payments from its collaborator, the Company recognizes such amounts in the period earned.

The Company's collaborators provide it with estimates of product sales and the Company's share of profits or losses, as applicable, for each quarter.

The estimates are revised, if necessary, in subsequent periods if the Company's actual share of profits or losses differ from those estimates.

Research and Development Expenses

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Costs associated with research and development are expensed.

For each clinical trial that we conduct, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter and remain in the trial, and/or the period over which clinical investigators, contract research organizations ("CROs"), or other third-party service providers are expected to provide services.

In the event of early termination of a clinical trial, we accrue and recognize expenses in an amount based on our estimate of the remaining noncancelable obligations associated with the winding-down of the clinical trial, including any applicable penalties.

For each clinical trial that the Company conducts, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter and remain in the trial, and/or the period over which clinical investigators, contract research organizations ("CROs"), or other third-party service providers are expected to provide services.

In the event of early termination of a clinical trial, the Company accrues and recognizes expenses in an amount based on its estimate of the remaining noncancelable obligations associated with the winding-down of the clinical trial, including any applicable penalties.

Stock-based Compensation

The Company recognizes stock-based compensation expense for equity grants under the Company's long-term incentive plans to employees and non-employee members of the Company's board of directors (as applicable) based on the grant-date fair value of those awards.

The Company recognizes stock-based compensation expense for equity grants under the Company's long-term incentive plans (including stock options, restricted stock awards, and restricted stock units (both time-based and performance-based)) to employees and non-employee members of the Company's board of directors (as applicable) based on the grant-date fair value of those awards.

The grant-date fair value of an award is generally recognized as compensation expense over the award's requisite service period.

The fair value of stock option awards is estimated using the Black-Scholes model.

Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited.

This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

The fair value of performance-based restricted stock units which are subject to vesting based on the Company’s attainment of pre-established market performance goals is estimated using a Monte Carlo simulation.

The probability of the number of actual shares expected to be earned is considered in the grant-date valuation, and therefore, stock-based compensation expense is not adjusted at the vesting date to reflect the actual number of shares earned.

In addition, the Company reassesses its forfeiture rate assumptions at least annually, considering both historical forfeiture experience and an estimate of future forfeitures for currently outstanding unvested awards.

The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards.

Additionally, the Company uses a Monte Carlo simulation to compute the estimated fair value of performance-based restricted stock units that are subject to vesting based on the Company’s attainment of pre-established criteria that include a market condition.

For performance-based restricted stock units that contain a performance condition, the Company recognizes stock-based compensation expense if and when the Company determines that it is probable the performance condition will be achieved (based on the number of shares expected to be vested and issued).

The Company reassesses the probability of achievement at each reporting period and adjusts compensation cost, as necessary.

If there are any changes in the Company's probability assessment, the Company recognizes a cumulative catch-up adjustment in the period of the change in estimate, with the remaining unrecognized expense recognized prospectively over the remaining requisite service period.

If the Company subsequently determines that the performance criteria are not met or are not expected to be met, any amounts previously recognized as compensation expense are reversed in the period when such determination is made.

The provision for income taxes includes U.S.

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A valuation allowance is established for deferred tax assets for which it is more likely than not that some portion or all of the deferred tax assets will not be realized.

Uncertain tax positions, for which management's assessment is that there is more than a 50% probability that the position will be sustained upon examination by a taxing authority based upon its technical merits, are subjected to certain recognition and measurement criteria.

The Company recognizes the financial statement effects of a tax position when management's assessment is that there is more than a 50% probability that the position will be sustained upon examination by a taxing authority based upon its technical merits.

Uncertain tax positions are recorded based upon certain recognition and measurement criteria.

The Company re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position.

The Company adjusts the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions.

The Company adjusts the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions.

The Company recognizes interest and penalties related to income tax matters in income tax expense.

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Diluted net income per share includes the potential dilutive effect of common stock equivalents as if such securities were converted or exercised during the period, when the effect is dilutive.

Common stock equivalents include:

(i) outstanding stock options and unvested restricted stock under the Company's long-term incentive plans, which are included under the treasury stock method when dilutive, and (ii) Common Stock that would be issued upon the achievement of certain market conditions, which are included under the treasury stock method when dilutive.

Common stock equivalents include outstanding stock options and unvested restricted stock under the Company's long-term incentive plans, which are included under the treasury stock method when dilutive.

Product Sales

Net product sales consist of the following:

(In millions) Year Ended December 31,

Net Product Sales in the United States 2021 2020 2019

$ 5,792.3 $ 4,947.2 $ 4,644.2

Year Ended December 31,

(In millions) 2022 2021 2020

$ 6,264.6 $ 5,792.3 $ 4,947.2

374.5 306.3 270.7

REGEN-COV ***

Praluent ®(c)

130.0 170.0 150.9

REGEN-COV ®(d)

— 5,828.0 185.7

ARCALYST ®(e)

$ 6,893.7 $ 12,117.2 $ 5,567.6

* Effective April 1, 2020, the Company became solely responsible for the development and commercialization of Praluent in the United States and records net product sales of Praluent in the United States.

(a) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States.

Effective July 1, 2022, the Company records global net product sales of Libtayo.

See Note 3 for further details.

(b) Rest of world ("ROW")

(c) Effective April 1, 2020, the Company became solely responsible for the development and commercialization of Praluent in the United States and records net product sales of Praluent in the United States.

Previously, Sanofi recorded net product sales of Praluent in the United States.

See Note 3 for further details.

** Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States.

Previously, the Company recorded net product sales of ARCALYST in the United States.

*** Net product sales of REGEN-COV in the United States relate to product sold in connection with our agreements with the U.S.

(d) Net product sales of REGEN-COV in the United States relate to product sold in connection with the Company's agreements with the U.S.

See Note 3 for further details.

(e) Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States.

Previously, the Company recorded net product sales of ARCALYST in the United States.

As of December 31, 2022 and 2021, the Company had $ 3.586 billion and $ 5.059 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.

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Collaboration, License, and Other Agreements

Amounts recognized in our Statements of Operations in connection with our collaborations with Sanofi are detailed below:

Amounts recognized in the Company's Statements of Operations in connection with its collaborations with Sanofi are detailed below:

Statement of Operations Classification Year Ended December 31,

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Reimbursement for manufacturing of commercial supplies Sanofi collaboration revenue $ 633.7 $ 488.8 $ 368.0

Reimbursement of research and development expenses Reduction of Research and development expense $ 175.9 $ 226.7 $ 277.7

Regeneron's obligation for its share of Sanofi research and development expenses Research and development expense $ ( 46.7 ) $ ( 77.6 ) $ ( 46.0 )

Reimbursement of commercialization-related expenses Reduction of Selling, general, and administrative expense $ 320.5 $ 359.4 $ 479.9

Other Sanofi collaboration revenue $ 28.7 $ — $ —

Reimbursements of R&D expenses, net of Regeneron's obligation for its share of Sanofi R&D expenses Reduction of R&D expense $ 43.0 $ 129.2 $ 149.1

Reimbursement of commercialization-related expenses Reduction of SG&A expense $ 437.4 $ 320.5 $ 359.4

Immuno-oncology ** :

Regeneron's share of losses in connection with commercialization of Libtayo outside the United States Sanofi collaboration revenue $ ( 13.6 ) $ ( 25.7 ) $ ( 21.7 )

Reimbursement for manufacturing of commercial supplies Sanofi collaboration revenue $ 14.0 $ 8.9 —

Reimbursement of research and development expenses Reduction of Research and development expense $ 85.1 $ 166.2 $ 163.0

Reimbursement of commercialization-related expenses Reduction of Selling, general, and administrative expense $ 89.6 $ 64.7 $ 10.3

Regeneron's obligation for its share of Sanofi commercial expenses Selling, general, and administrative expense $ ( 36.3 ) $ ( 22.4 ) $ ( 15.4 )

Regeneron's share of profits (losses) in connection with commercialization of Libtayo outside the United States Sanofi collaboration revenue $ 6.7 $ ( 13.6 ) $ ( 25.7 )

Reimbursement for manufacturing of ex-U.S.

commercial supplies Sanofi collaboration revenue $ 4.6 $ 14.0 $ 8.9

Reimbursement of R&D expenses Reduction of R&D expense $ 42.7 $ 85.1 $ 166.2

Reimbursement of commercialization-related expenses Reduction of SG&A expense $ 41.4 $ 89.6 $ 64.7

Regeneron's obligation for its share of Sanofi commercial expenses SG&A expense $ ( 19.9 ) $ ( 36.3 ) $ ( 22.4 )

Regeneron's obligation for Sanofi's share of Libtayo U.S.

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Amounts recognized in connection with up-front payments received Other operating income $ 35.1 $ 6.1 $ 210.6

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

Under the terms of the Antibody License and Collaboration Agreement ("LCA"), Sanofi is generally responsible for funding 80 %– 100 % of agreed-upon development costs.

We are obligated to reimburse Sanofi for 30 %– 50 % of worldwide development expenses that were funded by Sanofi (collectively, the "development balance") based on our share of collaboration profits from commercialization of collaboration products.

However, we are only required to apply 10 % of our share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs.

The Company's contingent reimbursement obligation (development balance) to Sanofi under the Antibody Collaboration was approximately $ 3.152 billion as of December 31, 2021.

Effective January 2018, the Company and Sanofi entered into a letter agreement (the "Letter Agreement") in connection with, among other matters, the allocation of additional funds to certain activities relating to dupilumab and itepekimab (collectively, the "Dupilumab/Itepekimab Eligible Investments").

Refer to the " Immuno-Oncology " section below for further details regarding the Letter Agreement and Note 11 for additional information regarding shares purchased by us from Sanofi.

* Net of one-time payment of $ 56.9 million to Sanofi in connection with the amendment to the Antibody License and Collaboration Agreement

** As described within the " Immuno-Oncology " section below, effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide

Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), 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 based on the Company's share of collaboration profits from commercialization of collaboration products.

Under the terms of the LCA, the Company was required to apply 10 % of its share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs.

On July 1, 2022, an amendment to the LCA became effective, pursuant to which the percentage of the Company's share of profits used to reimburse Sanofi for such development costs increased from 10 % to 20 %.

A portion of the value associated with the increase in reimbursement percentage was deemed to be contingent consideration attributable to the Company's acquisition of the Libtayo rights described within the " Immuno-Oncology " section below;

this portion will be recorded as an increase to the Libtayo intangible asset over time as the Company repays such development costs to Sanofi.

The Company's contingent reimbursement

obligation (development balance) to Sanofi under the Antibody Collaboration was approximately $ 2.864 billion as of December 31, 2022.

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

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In addition to profit and loss sharing, the Company is entitled to receive sales milestone payments from Sanofi.

In each of 2020 and 2021, the Company earned, and recognized as revenue, a $ 50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $ 1.0 billion and $ 1.5 billion, respectively, on a rolling twelve-month basis.

We are entitled to receive up to an aggregate of $ 150.0 million in additional sales milestone payments from Sanofi, which includes the next sales milestone payment of $ 50.0 million that would be earned when such sales outside the United States exceed $ 2.0 billion on a rolling twelve-month basis.

In April 2020, the Company and Sanofi entered into an amendment to the LCA in connection with, among other things, the removal of Praluent from the LCA such that (i) effective April 1, 2020, the LCA no longer governs the development, manufacture, or commercialization of Praluent and (ii) the quarterly period ended March 31, 2020 was the last quarter for which Sanofi and the Company shared profits and losses for Praluent under the LCA.

The parties also entered into a Praluent Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, became solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, became solely responsible for the development and commercialization of Praluent outside of the United States.

Under the Praluent Agreement, Sanofi will pay the Company a 5 % royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032.

The Company will not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States.

Although each party will be responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period, the Company will continue to supply drug substance to Sanofi and Sanofi will continue to supply finished product to Regeneron.

With respect to any intellectual property or product liability litigation relating to Praluent, the parties have agreed that, effective April 1, 2020, Regeneron and Sanofi each will be solely responsible for any such litigation (including damages and other costs and expenses thereof) in the United States and outside the United States, respectively, arising out of Praluent sales or other activities on or after April 1, 2020 (subject to Sanofi's right to set off a portion of any third-party royalty payments resulting from certain patent litigation proceedings against up to 50 % of any Praluent royalty payment owed to Regeneron).

The parties will each bear 50 % of any damages arising out of Praluent sales or other activities prior to April 1, 2020.

See Note 15 for discussion of legal proceedings related to Praluent.

The Company's significant promised goods and services in connection with the Antibody Collaboration consist of providing research and development services, including the manufacturing of clinical supplies, and providing commercial-related services, including the manufacturing of commercial supplies.

We recognize amounts in connection with the Antibody Collaboration based on the amount we have the right to invoice and such amount corresponds directly with our performance to date;

therefore, we do not disclose the value of the transaction price (i.e., the amount of consideration we expect to be entitled to) allocated to our remaining unsatisfied obligations.

In each of 2020 and 2021, the Company earned a $ 50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $ 1.0 billion and $ 1.5 billion, respectively, on a rolling twelve-month basis.

In 2022, the Company earned two additional $ 50.0 million sales-based milestones from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $ 2.0 billion and $ 2.5 billion, respectively, on a rolling twelve-month basis.

The Company is entitled to receive the final sales milestone payment of $ 50.0 million when such sales outside the United States exceed $ 3.0 billion on a rolling twelve-month basis.

and providing commercial-related services, including the manufacturing of commercial supplies.

The Company recognizes amounts in connection with the Antibody Collaboration based on the amount it has the right to invoice and such amount corresponds directly with the Company's performance to date;

therefore, the Company does not disclose the value of the transaction price (i.e., the amount of consideration the Company expects to be entitled to) allocated to its remaining unsatisfied obligations.

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

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$ 415.8 $ 368.7

Under the Praluent Agreement, Sanofi pays the Company a 5 % royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032.

The Company does not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States.

Although each party is responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period, the Company continues to supply drug substance to Sanofi and Sanofi continues to supply finished product to Regeneron.

With respect to any intellectual property or product liability litigation relating to Praluent, the parties have agreed that, effective April 1, 2020, Regeneron and Sanofi each are solely responsible for any such litigation (including damages and other costs and expenses thereof) in the United States and outside the United States, respectively, arising out of Praluent sales or other activities on or after April 1, 2020 (subject to Sanofi's right to set off a portion of any third-party royalty payments resulting from certain patent litigation proceedings against up to 50 % of any Praluent royalty payment owed to Regeneron).

The parties each bear 50 % of any damages arising out of Praluent sales or other activities prior to April 1, 2020.

See Note 16 for discussion of legal proceedings related to Praluent.

Immuno-Oncology

The Company is party to a collaboration with Sanofi to research, develop, and commercialize antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").

The IO Collaboration is governed by an Amended and Restated Immuno-oncology Discovery and Development Agreement ("Amended IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement ("IO License and Collaboration Agreement").

In connection with the execution of the original Immuno-oncology Discovery and Development Agreement in 2015 ("2015 IO Discovery Agreement"), which has been replaced by the Amended IO Discovery Agreement (as discussed below), Sanofi made a $ 265.0 million non-refundable up-front payment to the Company.

The Company was previously a party to a collaboration with Sanofi for antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").

The IO Collaboration was governed by an Amended and Restated Immuno-oncology Discovery and Development Agreement ("Amended IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement ("IO License and Collaboration Agreement").

In connection with the execution of the original Immuno-oncology Discovery and Development Agreement in 2015 ("2015 IO Discovery Agreement"), which was subsequently replaced by the Amended IO Discovery Agreement (as discussed below), Sanofi made a $ 265.0 million non-refundable up-front payment to the Company.

Pursuant to the 2015 IO Discovery Agreement, the Company was to identify and validate potential immuno-oncology targets and develop therapeutic antibodies against such targets through clinical proof-of-concept.

We are obligated to reimburse Sanofi for half of the development costs it funded that are attributable to clinical development of antibody product candidates from our share of future profits from commercialized IO Collaboration products.

However, the Company is only required to apply 10 % of its share of the profits from IO Collaboration products in any calendar quarter towards reimbursing Sanofi for these development costs.

The Company's contingent reimbursement obligation to Sanofi under the IO Collaboration was approximately $ 103 million as of December 31, 2021.

Effective December 31, 2018, the Company and Sanofi entered into the Amended IO Discovery Agreement, which narrowed the scope of the existing discovery and development activities conducted by the Company ("IO Development Activities") under the 2015 IO Discovery Agreement to developing therapeutic bispecific antibodies targeting (i) BCMA and CD3 (the "BCMAxCD3 Program") and (ii) MUC16 and CD3 (the "MUC16xCD3 Program") through clinical proof-of-concept.

The Amended IO Discovery Agreement provided for Sanofi’s payment of $ 461.9 million to the Company as consideration for (x) the termination of the 2015 IO Discovery Agreement, (y) the prepayment for certain IO Development Activities regarding the BCMAxCD3 Program and the MUC16xCD3 Program, and (z) the reimbursement of costs incurred by the Company under the 2015 IO Discovery Agreement during the fourth quarter of 2018.

Under the terms of the Amended IO Discovery Agreement, the Company was required to conduct development activities with respect to (i) the BCMAxCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $ 70.0 million and (ii) the MUC16xCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $ 50.0 million.

Effective December 31, 2018, the Company and Sanofi entered into the Amended IO Discovery Agreement, which narrowed the scope of the existing discovery and development activities conducted by the Company under the 2015 IO Discovery Agreement to developing therapeutic bispecific antibodies targeting (i) BCMA and CD3 and (ii) MUC16 and CD3 through clinical proof-of-concept.

During the first quarter of 2021, Sanofi did not exercise its options to license rights to these product candidates;

as a result, we retain the exclusive right to develop and commercialize such product candidates and Sanofi will receive a royalty on sales (if any).

as a result, the Company retains the exclusive right to develop and commercialize such product candidates and Sanofi will receive a royalty on sales (if any).

In addition, the Company has no further obligations to develop drug product candidates under the Amended IO Discovery Agreement.

In connection with the execution of the IO License and Collaboration Agreement in 2015, Sanofi made a $ 375.0 million non-refundable up-front payment to the Company.

Under the terms of the IO License and Collaboration Agreement, the parties are co-developing and co-commercializing Libtayo (cemiplimab).

The parties share equally, on an ongoing basis, agreed-upon development and commercialization expenses for Libtayo.

Pursuant to the Letter Agreement, the Libtayo development budget was increased and the Company allowed Sanofi to satisfy in whole or in part its funding obligations with respect to the Libtayo development and Dupilumab/Itepekimab Eligible Investments incurred in periods through September 30, 2020 by selling certain shares of our Common Stock owned by Sanofi;

if Sanofi desired to sell such shares, we were able to elect to purchase, in whole or in part, such shares from Sanofi.

See Note 11 for additional information regarding shares purchased by us from Sanofi.

The Company has principal control over the development of Libtayo and leads commercialization activities in the United States (see Note 2 for related product sales information), while Sanofi leads commercialization activities outside of the United States.

Sanofi co-commercializes Libtayo in the United States.

Each party has the right to co-commercialize licensed products in countries where it is not the lead commercialization party.

The parties share equally in profits and losses in connection with the commercialization of Libtayo.

In addition, the Company will be entitled to a milestone payment of $ 375.0 million in the event that global sales of Libtayo equal or exceed $ 2.0 billion in any consecutive twelve-month period.

In 2018, we and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E.

Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd.

to obtain a license under certain patents owned and/or exclusively licensed by one or more of those parties that includes the right to develop and sell Libtayo.

Under the agreement, we and Sanofi made an up-front payment of $ 20.0 million and are obligated to pay royalties of 8.0 % on worldwide sales of Libtayo through December 31, 2023, and royalties

of 2.5 % from January 1, 2024 through December 31, 2026.

The up-front payment was shared, and the royalties are shared, equally by us and Sanofi.

At the inception of the IO Collaboration, the Company's significant promised goods and services consisted of a license to certain rights and intellectual property and providing research and development services, including the manufacturing of clinical supplies.

The Company concluded that the license was not distinct, primarily as a result of (i) Sanofi being unable to benefit on its own or together with other resources that are readily available as the license provides access to Regeneron's complex and specialized know-how and (ii) the research and development services, including manufacturing in support of such services, were expected to significantly modify the initial license.

Therefore, the promised goods and services were considered a combined unit of account.

Consequently, the $ 640.0 million in aggregate up-front payments made by Sanofi during 2015 in connection with the execution of the IO Collaboration was recorded within other liabilities and has been included in the transaction price.

During 2021, we updated our estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $ 66.9 million as a reduction to other operating income.

During 2020, we updated our estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the Sanofi IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $ 135.4 million as an increase to other operating income.

Under the terms of the IO License and Collaboration Agreement, the parties were co-developing and co-commercializing Libtayo.

The parties shared equally, on an ongoing basis, development and commercialization expenses for Libtayo.

The Company had principal control over the development of Libtayo and led commercialization activities in the United States, while Sanofi led commercialization activities outside of the United States.

The parties shared equally in profits and losses in connection with the commercialization of Libtayo.

Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA").

In connection with the A&R IO LCA, in 2022, the Company made a $ 900.0 million up-front payment to Sanofi, as well as a $ 100.0 million regulatory milestone payment.

In addition, Sanofi earned a $ 65.0 million sales-based milestone upon the achievement of a specified amount of worldwide net product sales of Libtayo in 2022, and is eligible to receive an additional $ 35.0 million sales-based milestone upon the achievement of a specified amount of worldwide net product sales of Libtayo in 2023 (aggregate of $ 100.0 million in sales-based milestones eligible to be earned under the terms of the A&R IO LCA).

The Company also pays Sanofi an 11 % royalty on net product sales of Libtayo through March 31, 2034.

The transaction was accounted for as an asset acquisition and amounts paid to Sanofi in connection with obtaining the worldwide rights to Libtayo, including the up-front payment and any contingent consideration, are recorded as an intangible asset.

See Note 8 for additional information related to the intangible asset recorded in connection with the transaction.

In accordance with the Amended IO Discovery Agreement, the Company was obligated to reimburse Sanofi for half of the development costs it funded that were attributable to clinical development of product candidates from the Company's share of profits from commercialized IO Collaboration products.

Under the A&R IO LCA, the amount of development costs incurred under the IO Collaboration for which the Company was obligated to reimburse Sanofi was $ 35.0 million as of the effective date of the A&R IO LCA, and the Company pays Sanofi a 0.5 % royalty on net product sales of Libtayo until all such development costs have been reimbursed by Regeneron.

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

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Deferred revenue

$ 16.0 $ 10.7

Other liabilities

$ 276.1 $ 280.9

Other liabilities include up-front payments received from Sanofi for which recognition has been deferred.

The aggregate amount of the estimated consideration under the IO Collaboration related to the Company's obligation that was unsatisfied (or partially unsatisfied) as of December 31, 2021 was $ 570.3 million.

This amount is expected to be recognized over the remaining period in which the Company is obligated to satisfy its obligation in connection with performing development activities.

The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA and aflibercept 8 mg outside the United States.

All agreed-upon development expenses incurred by the Company and Bayer are shared equally.

Other liabilities included up-front payments received from Sanofi for which recognition had been deferred.

Such amounts were being recognized over the remaining period in which the Company was obligated to perform development activities.

In connection with the A&R IO LCA described above, the remaining IO Collaboration Other liabilities balance of $ 241.0 million as of July 1, 2022 was recognized as a reduction to the intangible asset during the third quarter of 2022.

During 2021, the Company updated its estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $ 66.9 million as a reduction to other operating income.

During 2020, the Company updated its estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $ 135.4 million as an increase to other operating income.

The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA (aflibercept) and aflibercept 8 mg outside the United States.

Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally.

The Company is also obligated to use commercially reasonable efforts to supply clinical and commercial bulk product.

Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales.

In Japan, the Company was entitled to receive a tiered percentage of between 33.5 % and 40.0 % of EYLEA net product sales through 2021, and thereafter, the companies share equally in profits and losses from sales.

Within the United States, the Company is responsible for commercialization and retains profits from such sales.

The Company is obligated to reimburse Bayer out of its share of the collaboration profits (including the Company's percentage of sales in Japan) for 50 % of the agreed upon development expenses that Bayer has incurred in accordance with a formula based on the amount of development expenses that Bayer has incurred and the Company's share of the collaboration profits, or at a faster rate at the Company's option.

Bayer markets EYLEA outside the United States and the companies share equally in profits and losses from sales.

In Japan, the Company was entitled to receive a tiered percentage of between 33.5 % and 40.0 % of EYLEA net product sales through 2021, and effective January 1, 2022, the companies share equally in profits and losses from sales in Japan.

The Company is obligated to reimburse Bayer out of its share of the collaboration profits for 50 % of the agreed-upon development expenses that Bayer has incurred in accordance with a formula based on the amount of development expenses that Bayer has incurred and the Company's share of the collaboration profits, or at a faster rate at the Company's option.

The Company's contingent reimbursement obligation to Bayer was approximately $ 273 million as of December 31, 2022.

Amounts recognized in our Statements of Operations in connection with our Bayer collaboration are as follows:

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

Statement of Operations Classification Year Ended December 31,

(In millions) 2022 2021 2020

Regeneron's net profit in connection with commercialization of EYLEA outside the United States

Other collaboration revenue $ 1,349.2 $ 1,107.9 $ 1,091.4

Reimbursement for manufacturing of commercial supplies

Other collaboration revenue $ 60.1 $ 78.2 $ 54.2

Reimbursement of development expenses

Reduction of Research and development expense

$ 46.1 $ 46.7 $ 23.0

Regeneron's obligation for its share of Bayer research and development expenses

Research and development expense

$ ( 40.9 ) $ ( 35.8 ) $ ( 20.1 )

The following table summarizes contract balances in connection with our Bayer collaboration:

Regeneron's share of profits in connection with commercialization of EYLEA outside the United States Other collaboration revenue $ 1,317.4 $ 1,349.2 $ 1,107.9

Reimbursement for manufacturing of ex-U.S.

commercial supplies Other collaboration revenue $ 91.4 $ 60.1 $ 78.2

One-time payment in connection with change in Japan arrangement Other collaboration revenue $ 21.9 $ — $ —

Reimbursement of R&D expenses Reduction of R&D expense $ 51.0 $ 46.1 $ 46.7

Regeneron's obligation for its share of Bayer R&D expenses R&D expense $ ( 34.3 ) $ ( 40.9 ) $ ( 35.8 )

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

As of December 31,

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$ 131.9 $ 129.4

The Company and Teva are parties to a collaboration agreement (the "Teva Collaboration Agreement") to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with Mitsubishi Tanabe Pharma Corporation.

In connection with the agreement, Teva made a $ 250.0 million non-refundable up-front payment in 2016.

The Company leads global development activities, and the parties share development costs equally, on an ongoing basis, under a global development plan.

The Company is also responsible for the manufacture and supply of fasinumab globally.

Within the United States, the Company will lead commercialization activities, and the parties will share equally in any profits and losses in connection with commercialization of fasinumab.

In the territory outside the United States, Teva will lead commercialization activities and the Company will supply product to Teva at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances).

As of December 31, 2021, the Company had received an aggregate $ 120.0 million of development milestones from Teva.

The Company is entitled to receive up to an aggregate of $ 340.0 million in additional development milestones and up to an aggregate of $ 1.890 billion in contingent payments upon achievement of specified annual net sales amounts.

At the inception of the Teva Collaboration Agreement, the Company's significant promised goods and services consisted of a license to certain rights and intellectual property and providing research and development services, including the manufacturing of clinical supplies.

The Company concluded that the license was not distinct, primarily as a result of (i) Teva being unable to benefit from the license on its own or together with other resources that are readily available as the license provides access to Regeneron's complex and specialized know-how and (ii) the research and development services, including manufacturing in support of such services, were expected to significantly modify the initial license.

Therefore, the promised goods and services were considered a combined unit of account.

Consequently, the $ 250.0 million up-front payment and development milestones received from Teva, as described above, have been recorded within other liabilities and included in the transaction price.

Amounts recognized in our Statements of Operations in connection with the Teva Collaboration Agreement are as follows:

Statement of Operations Classification Year Ended December 31,

(In millions) 2021 2020 2019

Reimbursement of research and development expenses

Reduction of Research and development expense

$ 42.4 $ 109.4 $ 122.9

Amounts recognized in connection with up-front and development milestone payments received

Other operating income

$ 26.2 $ 47.2 $ 82.2

During 2020, we updated our estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the Teva Collaboration Agreement, and, as a result, recognized a cumulative catch-up adjustment of $ 25.6 million as a reduction to other operating income.

The following table summarizes contract balances in connection with the Teva Collaboration Agreement:

As of December 31,

(In millions) 2021 2020

Accounts receivable, net $ 11.0 $ 27.7

Other liabilities $ 39.7 $ 66.8

Other liabilities include up-front and development milestone payments received from Teva for which recognition has been deferred.

The aggregate amount of the estimated consideration under the Teva Collaboration Agreement related to the Company's obligation that was unsatisfied (or partially unsatisfied) as of December 31, 2021 was $ 87.4 million.

This amount is expected to be recognized over the remaining period in which the Company is obligated to satisfy its obligation in connection with performing development activities.

In 2016, we entered into a license and collaboration agreement with Intellia Therapeutics, Inc.

In 2016, the Company entered into a license and collaboration agreement with Intellia Therapeutics, Inc.

to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development.

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Under the terms of the 2016 agreement, the parties agreed to a target selection process, whereby the Company may obtain exclusive rights in up to 10 targets to be chosen by the Company during the collaboration term, subject to various adjustments and limitations set forth in the agreement.

Certain targets that either we or Intellia select pursuant to the target selection process may be subject to a co-development and co-commercialization arrangement at our option or Intellia’s option, as applicable.

In 2020, we expanded our existing collaboration with Intellia to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the parties to jointly develop potential products for the treatment of hemophilia A and B.

In addition, we also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products.

In connection with the agreement, we made a $ 70.0 million up-front payment and purchased shares of Intellia common stock for an aggregate purchase price of $ 30.0 million.

The up-front payment and the amount paid in excess of the fair market value of the shares purchased, or $ 15.0 million, were recorded to Research and development expense during 2020.

REGEN-COV (casirivimab and imdevimab)

In the first quarter of 2020, we announced an expansion of our Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S.

Department of Health and Human Services ("HHS") was obligated to fund certain of our costs incurred for research and development activities related to COVID-19 treatments.

In July 2020, we entered into an agreement with entities acting at the direction of BARDA and the U.S.

Certain targets that either the Company or Intellia selects pursuant to the target selection process may be subject to a co-development and co-commercialization arrangement at the Company's option or Intellia’s option, as applicable.

In 2020, the Company expanded its existing collaboration with Intellia to provide the Company with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the parties to jointly develop potential products for the treatment of hemophilia A and B.

In addition, the Company also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products.

In connection with the agreement, in 2020, the Company made a $ 70.0 million up-front payment and purchased shares of Intellia common stock for an aggregate purchase price of $ 30.0 million.

The up-front payment and the amount paid in excess of the fair market value of the shares purchased, or $ 15.0 million, were recorded to Acquired in-process research and development expense.

In 2020, the Company expanded its Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S.

Department of Health and Human Services ("HHS") was obligated to fund certain of the Company's costs incurred for research and development activities related to COVID-19 treatments.

In 2020, the Company also entered into an agreement with entities acting at the direction of BARDA and the U.S.

Department of Defense to manufacture and deliver filled and finished drug product of REGEN-COV to the U.S.

The agreement, as subsequently amended, provided for payments to the Company of up to $ 465.9 million in the aggregate for bulk manufacturing of the drug substance, as well as fill/finish, storage, and other activities.

In January 2021, the Company announced an agreement with an entity acting on behalf of the U.S.

In January 2021, the Company entered into an agreement with the U.S.

Department of Defense and HHS to manufacture and deliver additional filled and finished drug product of REGEN-COV to the U.S.

Pursuant to the agreement, the U.S.

government was obligated to purchase 1.25 million doses of drug product, which we delivered by June 30, 2021, resulting in payments to the Company of $ 2.625 billion.

In September 2021, the Company announced an amendment to its January 2021 agreement to supply the U.S.

government was obligated to purchase 1.25 million doses of drug product, which the Company delivered by June 30, 2021, resulting in payments to the Company of $ 2.625 billion.

In September 2021, the Company entered into an amendment to its January 2021 agreement to supply the U.S.

government with an additional 1.4 million doses of REGEN-COV.

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government was obligated to purchase all filled and finished doses of such additional drug product delivered by January 31, 2022, resulting in payments to the Company of $ 2.940 billion in the aggregate.

Roche supplied a portion of the doses to Regeneron to fulfill our agreement with the U.S.

government (see "Roche" below for further details regarding our collaboration agreement with Roche).

Roche supplied a portion of the doses to Regeneron to fulfill the Company's agreement with the U.S.

government (see "Roche" below for further details regarding the Company's collaboration agreement with Roche).

As of December 31, 2021, the Company had completed its final deliveries of drug product under the agreements described above.

See Note 2 for REGEN-COV net product sales recognized in connection with these agreements.

In August 2020, we entered into a collaboration agreement (the "Roche 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).

We lead global development activities for casirivimab and imdevimab, and the parties jointly fund certain ongoing studies, as well as any mutually agreed additional new global studies to evaluate further the potential of casirivimab and imdevimab in treating or preventing COVID-19.

Under the terms of the agreement, each party is obligated to dedicate a certain amount of manufacturing capacity to casirivimab and imdevimab each year.

We distribute the product in the United States and Roche distributes the product outside of the United States.

See Note 2 for REGEN-COV net product sales recognized during the years ended December 31, 2021 and 2020 in connection with these agreements.

In 2020, the Company entered into a collaboration agreement (the "Roche 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 Company leads global development activities for REGEN-COV, and the parties jointly fund certain studies.

The Company has the right to distribute the product in the United States and Roche has the right to distribute the product outside of 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.

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If Regeneron is to make a true-up payment to Roche, such amount will be recorded to Cost of goods sold.

Amounts recognized in our Statements of Operations in connection with the Roche Collaboration Agreement are as follows:

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

Statement of Operations Classification Year Ended December 31,

(In millions) 2022 2021 2020

Global gross profit true-up payment from Roche in connection with sales of casirivimab and imdevimab Other collaboration revenue $ 361.8 —

Reimbursement of research and development expenses Reduction of Research and development expense $ 128.1 $ 78.5

Global gross profit true-up payment to Roche in connection with sales of casirivimab and imdevimab Cost of goods sold $ 259.6 —

Global gross profit payment from Roche in connection with sales of REGEN-COV and Ronapreve Other collaboration revenue $ 627.3 $ 361.8 $ —

Reimbursement of R&D expenses Reduction of R&D expense $ 6.8 $ 128.1 $ 78.5

Global gross profit payment to Roche in connection with sales of REGEN-COV and Ronapreve Cost of goods sold $ — $ 259.6 $ —

The following table summarizes contract balances in connection with the Roche Collaboration Agreement:

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In 2018, the Company and Alnylam Pharmaceuticals, Inc.

entered into a global, strategic collaboration to discover, develop, and commercialize RNA interference ("RNAi") therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.

Under the terms of the agreement, we made an up-front payment of $ 400.0 million to Alnylam, which was recorded in Research and development expense during 2019.

For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive up to an aggregate of $ 200.0 million in clinical proof-of-principle milestones for eye and CNS programs.

entered into a collaboration to discover RNA interference ("RNAi") therapeutics for nonalcoholic steatohepatitis ("NASH") and potentially other related diseases, as well as to research, co-develop and commercialize any therapeutic product candidates that emerge from these discovery efforts (including ALN-HSD, which is currently in clinical development).

Under the terms of the collaboration agreement, the parties share development costs equally.

During the fourth quarter of 2022, Alnylam elected to opt-out of further development activities related to ALN-HSD;

as a result, the Company retains the exclusive right to develop and commercialize such product and Alnylam will receive a royalty on sales (if any).

In 2019, the Company and Alnylam entered into a global, strategic collaboration 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 ("CNS"), in addition to a select number of targets expressed in the liver.

In connection with the collaboration, the Company made an up-front payment of $ 400.0 million to Alnylam, and also purchased shares of Alnylam common stock for $ 400.0 million.

For each program, the Company provides Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive up to an aggregate of $ 200.0 million in clinical proof-of-principle milestones for eye and CNS programs.

Under the collaboration, the parties plan to 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 License Agreement or a Co-Commercialization Collaboration Agreement structure.

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development/co-commercialization collaboration agreement ("Co-Co Collaboration Agreement") (under which the parties are advancing ALN-APP and ALN-PNP, which are currently in clinical development) or License Agreement structure.

The initial target nomination and discovery period is five years (which may under certain situations automatically be extended for up to seven years in the aggregate) (the "Research Term").

In addition, we have an option to extend the Research Term for an additional five-year period for a research extension fee ranging from $ 200.0 million to $ 400.0 million;

the actual amount of the fee will be determined based on the acceptance of one or more INDs (or their equivalent in certain other countries) for programs in the eye and CNS.

In connection with the collaboration, we also purchased shares of Alnylam common stock for aggregate cash consideration of $ 400.0 million.

In addition, during 2019, the parties entered into a Co-Commercialization Collaboration Agreement for a silencing RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam, with Alnylam as the lead party, and a License Agreement for a combination product consisting of such siRNA therapeutic (cemdisiran) and a fully human monoclonal antibody targeting C5 being developed by us (pozelimab), with us as the licensee.

Under the C5 siRNA Co-Commercialization Collaboration Agreement, the parties share costs equally and will split profits (if commercialized);

and under the License Agreement, the licensee is responsible for its own costs and expenses.

The C5 siRNA License Agreement contains a flat low double-digit royalty payable to Alnylam on our potential future net sales of the combination product only subject to customary reductions, as well as up to $ 325.0 million in sales milestones.

In addition, the Company has an option to extend the Research Term for an additional five-year period for a research extension fee ranging from $ 200.0 million to $ 400.0 million;

the actual amount of the fee will be determined based on the acceptance of one or more Investigational New Drug Applications ("INDs") (or their equivalent in certain other countries) for programs in the eye and CNS.

In addition, during 2019, the parties entered into a Co-Co Collaboration Agreement for cemdisiran, a small interfering RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam, with Alnylam as the lead party, and a License Agreement for a combination consisting of cemdisiran and a fully human monoclonal antibody targeting C5 being developed by the Company (pozelimab), with the Company as the licensee.

Under the C5 siRNA Co-Co Collaboration Agreement, the parties shared costs equally and under the License Agreement, the Company as the licensee is responsible for its own costs and expenses.

The C5 siRNA License Agreement contains a flat low double-digit royalty payable to Alnylam on potential future net sales of the combination only subject to customary reductions, as well as up to $ 325.0 million in sales milestones.

During the fourth quarter of 2022, the Company elected to opt-out of further development activities pursuant to the Co-Co Collaboration Agreement for cemdisiran as a monotherapy;

as a result, Alnylam retains the right to develop and commercialize such product and the Company will receive a royalty on sales (if any).

Amounts recognized in the Company's Statements of Operations in connection with the Alnylam agreements described above were not material for the years ended December 31, 2022, 2021, and 2020.

In addition, contract balances in the Company's Balance Sheets were not material as of December 31, 2022 and 2021.

In May 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc.

(“Checkmate”) for a total equity value of approximately $ 250 million.

The Company made an assessment as to whether the set of assets acquired constituted a business and should be accounted for as a business combination.

Given that substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset, vidutolimod, which is in clinical development for oncology, the transaction was accounted for as an asset acquisition.

As a result of the acquisition, the Company recorded (i) a charge of $ 195.0 million to Acquired in-process research and development and (ii) net assets of $ 35.3 million, net of cash, related to the assets acquired (including deferred tax assets and investments) and liabilities assumed.

The Company and Teva are parties to a collaboration agreement (the "Teva Collaboration Agreement") to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to the Company's collaboration agreement with Mitsubishi Tanabe Pharma Corporation.

Under the terms of the Teva Collaboration Agreement, the Company led global development activities and the parties share development costs equally.

In connection with the agreement, Teva made a $ 250.0 million non-refundable up-front payment in 2016, and as of December 31, 2022, the Company had received an aggregate $ 120.0 million of development milestones from Teva.

Amounts recognized in the Company's Statements of Operations in connection with the Teva Collaboration Agreement are as follows:

Statement of Operations Classification Year Ended December 31,

(In millions) 2022 2021 2020

Amounts recognized in connection with up-front and development milestone payments received

Other operating income

$ 33.3 $ 26.2 $ 47.2

In addition, the Company recognized reimbursement of R&D expenses (as a reduction of R&D expense) of $ 42.4 million and $ 109.4 million for the years ended December 31, 2021 and 2020, respectively.

Such amount was not material for the year ended December 31, 2022.

The following table summarizes contract balances in connection with the Teva Collaboration Agreement:

As of December 31,

(In millions) 2022 2021

Accounts receivable, net $ 1.6 $ 11.0

Other liabilities $ — $ 39.7

Other liabilities included up-front and development milestone payments received from Teva for which recognition had been deferred.

During 2022, the Company discontinued further clinical development of fasinumab and, as a result, recorded $ 31.9 million as an increase to Other operating income as the Company deemed its obligation to provide development services in connection with the Teva Collaboration Agreement to be complete.

In addition to the collaboration agreements discussed above, the Company has various other collaboration agreements that are not individually significant to its operating results or financial condition at this time.

Pursuant to the terms of those agreements, the Company may be required to pay, or it may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of various development and commercial milestones) which in the aggregate could be significant.

The Company may also incur, or get reimbursed for, significant research and development costs if the related product candidate(s) were to advance to late stage clinical trials.

The Company may also incur, or get reimbursed for, significant research and development costs.

In addition, if any products related to these collaborations are approved for sale, the Company may be required to pay, or it may receive, royalties on future sales.

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Certificates of deposit 255.2 — ( 0.1 ) 255.1

Asset-backed securities 42.0 — ( 0.1 ) 41.9

$ 8,428.7 $ 10.8 $ ( 42.3 ) $ 8,397.2

The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates.

The available-for-sale debt securities listed as of December 31, 2021 mature at various dates through November 2026.

The available-for-sale debt securities listed as of December 31, 2022 mature at various dates through April 2028.

The fair values of available-for-sale debt securities by contractual maturity consist of the following:

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Maturities after one year through five years 5,381.4 5,588.1

Maturities after five years 0.4 —

$ 10,018.2 $ 8,397.2

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Sovereign bonds 18.6 ( 1.1 ) 45.6 ( 1.9 ) 64.2 ( 3.0 )

Commercial paper 295.7 ( 0.1 ) — — 295.7 ( 0.1 )

Certificates of deposit 40.2 ( 0.1 ) — — 40.2 ( 0.1 )

3 unchanged sentences

Corporate bonds $ 5,889.3 $ ( 40.9 ) $ — $ — $ 5,889.3 $ ( 40.9 )

Realized gains and losses on sales of marketable securities were no t material for the year ended December 31, 2021.

Realized gains on sales of marketable securities were $ 29.0 million and realized losses were no t material for the year ended December 31, 2020.

Realized gains on sales of marketable securities were no t material and there were no realized losses for the year ended December 31, 2019.

government and government agency obligations 90.0 ( 0.8 ) — — 90.0 ( 0.8 )

Sovereign bonds 37.0 ( 0.3 ) — — 37.0 ( 0.3 )

Commercial paper 295.7 ( 0.1 ) — — 295.7 ( 0.1 )

Certificates of deposit 169.4 ( 0.1 ) — — 169.4 ( 0.1 )

Asset-backed securities 34.9 ( 0.1 ) — — 34.9 ( 0.1 )

$ 6,516.3 $ ( 42.3 ) $ — $ — $ 6,516.3 $ ( 42.3 )

The unrealized losses on corporate bonds as of December 31, 2022 were primarily driven by increases in 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 years ended December 31, 2022, 2021, and 2020, amounts reclassified from Accumulated other comprehensive income (loss) into Other income (expense), net were related to realized gains and losses on sales of available-for-sale debt securities.

Realized gains and losses on sales of marketable securities were not material for the years ended December 31, 2022, 2021, and 2020.

Interest income of $ 160.1 million, $ 45.8 million, and $ 75.4 million for the years ended December 31, 2022, 2021, and 2020, respectively, was recognized in Other income (expense), net.

Fair Value Measurements

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Certificates of deposit 255.1 — 255.1

Asset-backed securities 41.9 — 41.9

Equity securities (unrestricted) 58.4 58.4 —

2 unchanged sentences

The Company held certain restricted equity securities as of December 31, 2022 which are subject to transfer restrictions that expire at various dates throug h 2024 .

During the years ended December 31, 2021, 2020, and 2019, we recorded $ 386.1 million, $ 196.0 million, and $ 118.3 million of net unrealized gains, respectively, on equity securities in Other income (expense), net.

During the year ended December 31, 2022, the Company recorded $ 39.8 million of net unrealized losses on equity securities in Other income (expense), net.

During the years ended December 31, 2021 and 2020, the Company recorded $ 386.1 million, and $ 196.0 million, respectively, of net unrealized gains on equity securities in Other income (expense), net.

In addition to the investments summarized in the table above, as of December 31, 2022 and 2021, the Company had $ 48.3 million and $ 40.0 million, respectively, in equity investments that do not have a readily determinable fair value.

These investments are recorded within Other noncurrent assets.

The fair value of our long-term debt (see Note 9), which was determined based on Level 2 inputs, was estimated to be $ 1.887 billion and $ 1.958 billion as of December 31, 2021 and 2020, respectively.

The fair value of the Company's long-term debt (see Note 10), which was determined based on Level 2 inputs, was estimated to be $ 1.443 billion and $ 1.887 billion as of December 31, 2022 and 2021, respectively.

Inventories consist of the following:

8 unchanged sentences

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

For the years ended December 31, 2021, 2020, and 2019, Cost of goods sold included inventory write-offs and reserves totaling $ 457.1 million, $ 39.2 million, and $ 73.8 million, respectively.

Included in the 2021 write-off and reserve amount was a fourth quarter charge of $ 231.7 million to write down our REGEN-COV inventory as a result of data that showed REGEN-COV was highly unlikely to be active against the Omicron variant and the FDA revision of the EUA for REGEN-COV, pursuant to which REGEN-COV was no longer authorized for use in any U.S.

states, territories, or jurisdictions.

For the years ended December 31, 2022 and 2021, Cost of goods sold included inventory write-offs and reserves of $ 258.7 million and $ 457.1 million, respectively, primarily related to REGEN-COV.

Inventory write-offs and reserves for the year ended December 31, 2020 were not material.

Property, Plant, and Equipment

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Depreciation and amortization expense on property, plant, and equipment was $ 303.9 million, $ 281.1 million, and $ 230.8 million for the years ended December 31, 2022, 2021, and 2020, respectively.

As of December 31, 2021 and 2020, $ 2.684 billion and $ 2.398 billion, respectively, of the Company's net property, plant, and equipment was located in the United States and $ 797.8 million and $ 823.8 million, respectively, was located in Europe (primarily in Ireland).

As of December 31, 2022 and 2021, $ 2.960 billion and $ 2.684 billion, respectively, of the Company's net property, plant, and equipment was located in the United States and $ 803.0 million and $ 797.8 million, respectively, was located outside the United States (primarily in Ireland).

Intangible Assets

Intangible assets consist of the following:

As of December 31,

(In millions) Estimated Useful Life Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross carrying Amount Accumulated Amortization Net Carrying Amount

Acquired product rights - Libtayo 13 years

$ 946.3 $ ( 35.7 ) $ 910.6 $ — $ — $ —

Other intangibles 5 – 8 years

10.0 ( 5.1 ) 4.9 29.3 ( 22.6 ) 6.7

Intangible assets, net $ 956.3 $ ( 40.8 ) $ 915.5 $ 29.3 $ ( 22.6 ) $ 6.7

As described in Note 3, the Company recorded an intangible asset in connection with obtaining the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.

The intangible asset recognized upon the effective date of the A&R IO LCA primarily consisted of the $ 900.0 million up-front payment, offset by the remaining IO Collaboration Other liabilities balance of $ 241.0 million.

During the year ended December 31, 2022, the Company recorded additions to the Libtayo intangible asset primarily related to contingent consideration (including regulatory and sales-based milestones, as described in Note 3) and other amounts due to Sanofi in connection with obtaining the worldwide rights to Libtayo.

Amortization expense on intangible assets was $ 37.6 million for the year ended December 31, 2022.

Amortization expense for the years ended December 31, 2021 and 2020 was not material.

As of December 31, 2022, assuming no changes in the gross carrying amount of intangible assets, amortization expense is estimated to be approximately $ 72 million for each of the years ending December 31, 2023 through December 31, 2027.

Accrued Expenses and Other Current Liabilities

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Credit Facility

In December 2018, we entered into an agreement with a syndicate of lenders (the "Credit Agreement") which provides for a $ 750.0 million senior unsecured five-year revolving credit facility (the "Credit Facility").

The Credit Agreement includes an option for us to elect to increase the commitments under the Credit Facility and/or to enter into one or more tranches of term loans in the aggregate principal amount of up to $ 250.0 million, subject to the consent of the lenders providing the additional commitments or term loans, as applicable, and certain other conditions.

Proceeds of the loans under the Credit Facility may be used to finance working capital needs, and for general corporate or other lawful purposes, of Regeneron and its subsidiaries.

In December 2018, the Company entered into an agreement with a syndicate of lenders (the "2018 Credit Agreement") which provided for a $ 750.0 million senior unsecured five-year revolving credit facility.

The 2018 Credit Agreement, which was to mature in December 2023, included an option for the Company to elect to increase the commitments under the Credit Facility and/or to enter into one or more tranches of term loans in the aggregate principal amount of up to $ 250.0 million, subject to the consent of the lenders providing the additional commitments or term loans, as applicable, and certain other conditions.

In December 2022, the Company entered into an agreement with a syndicate of lenders (the "2022 Credit Agreement") which provides for a $ 750.0 million senior unsecured five-year revolving credit facility (the "2022 Credit Facility") and replaces the 2018 Credit Agreement, which was contemporaneously terminated.

The 2022 Credit Agreement includes an option for the Company to elect to increase the commitments under the 2022 Credit Facility and/or to enter into one or more tranches of term loans in the aggregate principal amount of up to $ 500.0 million, subject to the consent of the lenders providing the additional commitments or term loans, as applicable, and certain other conditions.

The 2022 Credit Agreement also provides a $ 50.0 million sublimit for letters of credit.

The Credit Agreement includes an option for us to elect to extend the maturity date of the Credit Facility beyond December 2023, subject to the consent of the extending lenders and certain other conditions.

As set forth in the 2022 Credit Agreement, the Company has the option to amend the 2022 Credit Agreement to establish environmental, social, and governance targets which will be used to adjust pricing under the 2022 Credit Facility, subject to parameters to be provided in the 2022 Credit Agreement.

Proceeds of the loans under the 2022 Credit Facility may be used to finance working capital needs, and for general corporate or other lawful purposes, of Regeneron and its subsidiaries.

Regeneron Pharmaceuticals, Inc.

has guaranteed all obligations under the 2022 Credit Facility.

The 2022 Credit Agreement includes an option for the Company to elect to extend the maturity date of the 2022 Credit Facility beyond December 2027, subject to the consent of the extending lenders and certain other conditions.

Amounts borrowed under the 2022 Credit Facility may be prepaid, and the commitments under the 2022 Credit Facility may be terminated, at any time without premium or penalty.

We had no borrowings outstanding under the Credit Facility as of December 31, 2021.

The Credit Agreement contains financial and operating covenants.

The Company was in compliance with all covenants of the Credit Facility as of December 31, 2021.

Bridge Loan Facility

As described in Note 11, in the second quarter of 2020, we purchased shares of our Common Stock from Sanofi in connection with Sanofi's secondary offering of our Common Stock held by Sanofi.

This purchase was partially funded with proceeds from loans under a $ 1.5 billion senior unsecured bridge loan facility (the "Bridge Facility") which was entered into in May 2020.

The loans under the Bridge Facility bore interest at a variable interest rate based on either the London Interbank Offered Rate or the alternate base rate, plus an applicable margin that varied with our debt rating and total leverage ratio.

The Bridge Facility was repaid in full during the third quarter of 2020 following the closing of the issuance and sale of the Company's senior notes (as described below).

In August 2020, we issued and sold $ 1.250 billion aggregate principal amount of senior unsecured notes due 2030 and $ 750 million aggregate principal amount of senior unsecured notes due 2050 (collectively, the "Notes").

Net proceeds from the issuance and sale of the Notes (after deducting underwriting discounts and offering expenses) were used in part to repay in full the Bridge Facility described above.

The Company had no borrowings outstanding under the 2022 Credit Facility as of December 31, 2022.

The 2022 Credit Agreement contains operating covenants and a maximum total leverage ratio financial covenant.

The Company was in compliance with all covenants of the 2022 Credit Agreement as of December 31, 2022.

In August 2020, the Company issued and sold $ 1.250 billion aggregate principal amount of senior unsecured notes due 2030 and $ 750 million aggregate principal amount of senior unsecured notes due 2050 (collectively, the "Notes").

The underwriting discounts and offering expenses are being amortized as additional interest expense over the period from issuance through maturity.

Long-term debt in connection with our senior unsecured notes, net of underwriting discounts and offering expenses, consists of the following:

December 31, December 31,

Long-term debt in connection with the Notes, net of underwriting discounts and offering expenses, consists of the following:

As of December 31,

(In millions) 2022 2021

4 unchanged sentences

Interest on each series of Notes is payable semi-annually in arrears on March 15 and September 15 of each year until their respective maturity dates.

Interest expense related to the Notes was $ 44.4 million and $ 17.6 million for the years ended December 31, 2021 and 2020, respectively.

Interest expense related to the Notes was $ 44.3 million, $ 44.4 million, and $ 17.6 million for the years ended December 31, 2022, 2021, and 2020, respectively.

The Notes may be redeemed at the Company’s option at any time at 100 % of the principal amount plus accrued and unpaid interest, and, until a specified period before maturity, a specified make-whole amount.

3 unchanged sentences

See Note 16 for disclosures related to legal contingencies.

We conduct certain of our research, development, and administrative activities at leased facilities.

We also lease certain warehouses and vehicles.

The Company conducts certain of its research, development, and administrative activities at leased facilities.

The Company also leases vehicles and other assets.

Operating leases

Amounts recognized in our Consolidated Balance Sheets and Statements of Operations included in this report associated with operating leases were not material.

Amounts recognized in the Company's Consolidated Balance Sheets and Statements of Operations included in this report associated with operating leases were not material.

Operating lease right-of-use assets are included within Other noncurrent assets, and lease liabilities are included in Accrued expenses and other current liabilities and Other noncurrent liabilities.

Finance leases

In March 2017, we entered into a Participation Agreement with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital LLC ("BAL"), as lessor, and a syndicate of lenders (collectively with BAL, the "Lease Participants"), which provided for $ 720.0 million of lease financing from the Lease Participants for the acquisition of laboratory and office facilities in Tarrytown, New York (the "Facility").

In March 2017, we also entered into a Lease and Remedies Agreement with BAL, pursuant to which we have leased the Facility from BAL for a five-year term ending in March 2022.

The Participation Agreement, the Lease and Remedies Agreement, and certain other related agreements were amended and restated in May 2019, among other things, to revise certain covenants, representations and warranties, and events of default to be substantially similar to those set forth in our Credit Facility (as so amended and restated, the "Participation Agreement" and the "Lease," respectively).

The Lease requires us to pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility.

We are also required to make monthly payments of basic rent during the term of the Lease in an amount equal to a variable rate per annum based on the one-month LIBOR, plus an applicable margin that varies with our debt rating and total leverage ratio.

The Participation Agreement and the Lease include an option for us to elect to extend the maturity date of the Participation Agreement and the term of the Lease for an additional five-year period, subject to the consent of all the Lease Participants and certain other conditions.

We also have the option prior to the end of the term of the Lease to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Lease Participants' advances under the Participation Agreement, all accrued and unpaid interest and yield thereon, and all other outstanding amounts under the Participation Agreement, the Lease, and certain related documents or (b) sell the Facility to a third party on behalf of BAL.

The advances under the Participation Agreement mature, and all amounts outstanding thereunder will become due and payable in full, at the end of the term of the Lease.

In September 2021, we delivered a request to the Lease Participants to potentially exercise the option for a five-year extension of the term of the Lease and the maturity date under the Participation Agreement.

In November 2021, the Lease Participants consented to such extension, subject to the satisfaction of certain conditions prior to the expiration of the existing term in March 2022, including the negotiation and execution of satisfactory definitive documentation setting forth the terms and conditions that would apply during such potential extended term.

We are negotiating such documentation with the Lease Participants, but there can be no assurance that such extension will become effective.

The Lease is classified as a finance lease as we have the option to purchase the Facility under terms that make it reasonably certain to be exercised.

The agreements governing the Lease financing contain financial and operating covenants.

In March 2017, the Company entered into a Participation Agreement with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital LLC ("BAL"), as lessor, and a syndicate of lenders (collectively with BAL, the "Lease Participants"), which provided for $ 720.0 million of lease financing from the Lease Participants for the acquisition of laboratory and office facilities in Tarrytown, New York (the "Facility").

In March 2017, the Company also entered into a Lease and Remedies Agreement with BAL, pursuant to which the Company leased the Facility from BAL for a five-year term which ended in March 2022.

In March 2022, the Company entered into a Second Amended and Restated Lease and Remedies Agreement (the "Restated Lease") with BAL, as lessor (the "Lessor"), which amends, restates, and extends its lease of the Facility.

In March 2022, the Company also entered into a Second Amended and Restated Participation Agreement (the "Restated Participation Agreement") with Bank of America, N.A., as administrative agent, the Lessor, and a syndicate of financial institutions as rent assignees (collectively with the Lessor, the "Participants"), which amends and restates the original Participation Agreement entered into in March 2017.

The original Participation Agreement and certain related agreements were amended and restated in order to, among other things, (i) effect a five-year extension of the original March 2022 maturity date of the $ 720.0 million lease financing and the end of the term of the Company's lease of the Facility from the Lessor to March 2027, at which time all amounts outstanding thereunder will become due and payable in full, and (ii) modify the rate of the interest or yield that is payable to the Participants.

In accordance with the terms of the Restated Lease, the Company continues to pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility.

The Company is also required to make monthly payments of basic rent during the term of the Restated Lease in an amount equal to a variable rate per annum, which was modified in connection with the Restated Lease, to be an adjusted one-month forward-looking term rate based on the Secured Overnight Financing Rate ("SOFR"), plus an applicable margin that varies with the Company's debt rating and total leverage ratio.

The Restated Participation Agreement and Restated Lease include an option for the Company to elect to further extend the maturity date of the Restated Participation Agreement and the term of the Restated Lease for an additional five-year period, subject to the consent of all the Participants and certain other conditions.

The Company also has the option prior to the end of the term of the Restated Lease to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Restated Participation Agreement, all accrued and unpaid yield thereon, and all other outstanding amounts under the Restated Participation Agreement, Restated Lease, and certain related documents or (b) sell the Facility to a third party on behalf of the Lessor.

Consistent with the original lease, the Restated Lease continues to be classified as a finance lease as the Company has the option to purchase the Facility under terms that make it reasonably certain to be exercised.

The agreements governing the Restated Lease financing contain financial and operating covenants.

Such financial covenants and certain of the operating covenants are substantially similar to the covenants set forth in the Company's $ 750.0 million 2018 Credit Agreement.

The Company was in compliance with all such covenants as of December 31, 2022.

Amounts recognized in the Consolidated Balance Sheet related to the Lease are included in the table below.

Other than the Lease described above, we had no leases accounted for as finance leases as of December 31, 2021 and 2020.

Other than the Lease described above, the Company had no leases accounted for as finance leases as of December 31, 2022 and 2021.

As of December 31,

(In millions) Classification 2022 2021

Finance lease right-of-use assets Property, plant, and equipment, net (1)

Finance lease right-of-use assets Property, plant, and equipment, net (a)

$ 620.3 $ 631.3

Finance lease liabilities Finance lease liabilities $ 720.0 $ 719.7

(1) Finance lease right-of-use assets were recorded net of accumulated amortization of $ 104.9 million and $ 90.5 million as of December 31, 2021 and 2020, respectively.

(a) Finance lease right-of-use assets were recorded net of accumulated amortization of $ 119.4 million and $ 104.9 million as of December 31, 2022 and 2021, respectively.

Finance lease costs consist of the following:

4 unchanged sentences

$ 36.1 $ 26.3

Other information related to our finance lease includes the following:

Other information related to the Company's finance lease includes the following:

As of December 31,

2 unchanged sentences

Supplemental information

The following is a maturity analysis of our finance lease liabilities:

The following is a maturity analysis of the Company's finance lease liability:

(In millions) As of December 31, 2022

1 unchanged sentence

Imputed interest ( 153.4 )

Debt financing costs ( 0.4 )

Total lease liabilities $ 719.7

Total lease liability $ 720.0

Research Collaboration and Licensing Agreements

As part of our research and development efforts, we enter into research collaboration and licensing agreements with other companies, universities, and other organizations.

As part of the Company's research and development efforts, the Company enters into research collaboration and licensing agreements with other companies, universities, and other organizations.

These agreements contain varying terms and provisions which include fees to be paid by the Company, services to be provided, and license rights to certain proprietary technology developed under the agreements.

Some of these agreements may require the Company to pay additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of various development and commercial milestones).

Additionally, we have in-licensed patent and/or technology pursuant to agreements which contain provisions that require the Company to pay royalties, as defined, at rates that range from 0.5 % to 10.0 %, in the event the Company sells or licenses any proprietary products developed under the respective agreements.

Additionally, the Company has in-licensed patent and/or technology pursuant to agreements which contain provisions that require the Company to pay royalties, as defined, at rates that range from 0.5 % to 12.0 %, in the event the Company sells or licenses any proprietary products developed under the respective agreements.

The Company also has contingent reimbursement obligations to its collaborators Sanofi and Bayer out of the respective collaboration's profits, if they are sufficient for that purpose.

See Note 3 for a more detailed description of collaboration, license, and other agreements.

For the years ended December 31, 2021, 2020, and 2019, the Company recorded royalty expense (net of reimbursements from collaborators, as applicable) in Cost of goods sold and Cost of collaboration and contract manufacturing of $ 66.9 million, $ 56.5 million, and $ 47.0 million, respectively, based on product sales of commercial products under various licensing agreements.

As described in Note 3, as a result of obtaining worldwide rights to Libtayo, the Company pays Sanofi a royalty on net product sales of Libtayo.

In addition, in 2018, the Company and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E.

Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd.

to obtain a license under certain patents owned and/or exclusively licensed by one or more of those parties that includes the right to develop and sell Libtayo.

Under the agreement, the Company is obligated to pay royalties of 8.0 % on worldwide sales of Libtayo through December 31, 2023, and royalties of 2.5 % from January 1, 2024 through December 31, 2026.

Prior to July 1, 2022, royalties on such sales were shared equally by the Company and Sanofi.

For the years ended December 31, 2022, 2021, and 2020, the Company recorded royalty expense (net of reimbursements from collaborators, as applicable) in Cost of goods sold and Cost of collaboration and contract manufacturing of $ 84.5 million, $ 66.9 million, and $ 56.5 million, respectively, based on product sales under various licensing agreements.

Stockholders' Equity

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Share Repurchase Programs

In November 2019, our board of directors authorized a share repurchase program to repurchase up to $ 1.0 billion of our Common Stock.

In November 2019, the Company's board of directors authorized a share repurchase program to repurchase up to $ 1.0 billion of the Company's Common Stock.

The share repurchase program permitted 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.

As of December 31, 2020, the Company had repurchased the entire $ 1.0 billion it was authorized to repurchase under the program.

In January 2021, our board of directors authorized a share repurchase program to repurchase up to $ 1.5 billion of our Common Stock.

In January 2021, the Company's board of directors authorized a share repurchase program to repurchase up to $ 1.5 billion of the Company's Common Stock.

The share repurchase program was approved under terms substantially similar to the November 2019 share repurchase program described above.

As of December 31, 2021, the Company had repurchased the entire $ 1.5 billion of its Common Stock that it was authorized to repurchase under the program.

In November 2021, our board of directors authorized an additional share repurchase program to repurchase up to $ 3.0 billion of our Common Stock.

The share repurchase program was approved under terms substantially similar to the share repurchase programs above.

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.

In November 2021, 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 was approved under terms substantially similar to the share repurchase programs described above.

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 December 31, 2021, $ 2.845 billion remained available for share repurchases under the November 2021 program.

The table below summarizes the shares of our Common Stock we repurchased under the programs described above and the cost of the shares received, which were recorded as Treasury Stock.

As of December 31, 2022, $ 745.2 million remained available for share repurchases under the November 2021 program.

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

Year Ended December 31,

(In millions) 2022 2021 2020

Number of shares repurchased 3.0 1.6 0.7

Total cost of shares received $ 1,655.0 $ 746.0 $ 254.0

Number of shares 3.3 3.0 1.6

Total cost of shares $ 2,099.8 $ 1,655.0 $ 746.0

In January 2023, 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.

The program has no time limit and can be discontinued at any time.

Share 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.

Sanofi Funding of Certain Development Costs

As described in Note 3, in 2018, we and Sanofi entered into a Letter Agreement, which, among other things, granted Sanofi a limited waiver of Sanofi's lock-up obligations under the amended and restated investor agreement between us and Sanofi in order to allow Sanofi to satisfy its funding obligations with respect to Libtayo development costs and/or Dupilumab/Itepekimab Eligible Investments for quarterly periods ending on September 30, 2020 by selling our Common Stock owned by Sanofi.

During 2020 and 2019, Sanofi elected to sell, and we elected to purchase, shares of our Common Stock to satisfy Sanofi's funding obligation related to such activities.

Consequently, we recorded the cost of the shares received, or $ 135.0 million and $ 102.7 million, as Treasury Stock during 2020 and 2019, respectively.

In 2018, the Company and Sanofi entered into an agreement, which, among other things, granted Sanofi a limited waiver of Sanofi's lock-up obligations under the amended and restated investor agreement between the Company and Sanofi in order to allow Sanofi to satisfy its funding obligations with respect to Libtayo development costs and/or certain activities relating to dupilumab and itepekimab incurred in quarterly periods through September 30, 2020 by selling shares of the Company's Common Stock owned by Sanofi.

During 2020, Sanofi elected to sell, and the Company elected to purchase, shares of our Common Stock to satisfy Sanofi's funding obligation related to such activities.

Consequently, the Company recorded the cost of the shares received, or $ 135.0 million, as Treasury Stock during 2020.

Additional Stock Purchased from Sanofi

In May 2020, a secondary offering of 13,014,646 shares of our Common Stock (the "Secondary Offering") held by Sanofi was completed.

In connection with the Secondary Offering, we also purchased 9,806,805 shares directly from Sanofi for an aggregate purchase amount of $ 5.0 billion (the "Stock Purchase").

See Note 9 for additional information.

As a result of the Secondary Offering and the Stock Purchase, Sanofi disposed of all of its shares of our Common Stock, other than 400,000 shares that it retained as of the closing of the Secondary Offering and the Stock Purchase (a portion of which Sanofi used for the funding of certain development costs described above).

In May 2020, the Company entered into an amendment to the amended and restated investor agreement, which provides, among other things, that following the Secondary Offering and Share Purchase, (1) the “standstill” provisions, which contractually prohibit Sanofi from seeking to directly or indirectly exert control of the Company, continue to apply pursuant to their terms and (2) the voting commitments contained in the investor agreement continue to apply to the shares of Common Stock held by Sanofi and its affiliates following the secondary offering and stock repurchase, for so long as such shares are held by them.

In May 2020, a secondary offering of 13,014,646 shares of the Company's Common Stock (the "Secondary Offering") held by Sanofi was completed.

In connection with the Secondary Offering, the Company also purchased 9,806,805 shares directly from Sanofi for an aggregate purchase amount of $ 5.0 billion (the "Stock Purchase").

As a result of the Secondary Offering and the Stock Purchase, Sanofi disposed of all of its shares of the Company's Common Stock, other than 400,000 shares that it retained as of the closing of the Secondary Offering and the Stock Purchase (a portion of which Sanofi used for the funding of certain development costs described above).

Arrangements with Other Collaborators

In connection with the Company's license and collaboration agreements with Bayer for the joint development and commercialization outside the United States of antibody product candidates to PDGFR-beta and Ang2, Bayer is bound by certain "standstill" provisions, which contractually prohibit Bayer from seeking to influence the control of the Company or acquiring more than 20 % of the Company's outstanding shares of Class A Stock and Common Stock (taken together).

With respect to each of these agreements, this prohibition will remain in place until the earliest of (i) the fifth anniversary of the termination of the agreement (which, in the case of the PDGFR-beta license and collaboration agreement, will occur on July 31, 2022, and, in the case of the Ang2 agreement, will occur on November 1, 2023) or (ii) other specified events.

In connection with the Company's license and collaboration agreement with Bayer for the joint development and commercialization outside the United States of antibody product candidates to Ang2, Bayer is bound by certain "standstill" provisions, which contractually prohibit Bayer from seeking to influence the control of the Company or acquiring more than 20 % of the Company's outstanding shares of Class A Stock and Common Stock (taken together).

This prohibition will remain in place until the earliest of (i) the fifth anniversary of the termination of the agreement (which will occur on November 1, 2023) or (ii) other specified events.

Further, pursuant to the 2016 Teva Collaboration Agreement, Teva and its affiliates are bound by certain "standstill" provisions, which contractually prohibit them from seeking to directly or indirectly exert control of the Company or acquiring more than 5 % of the Company's Class A Stock and Common Stock (taken together).

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Stock option awards grant Participants the right to purchase shares of Common Stock at prices determined by the Committee, with exercise prices that are equal to or greater than the average of the high and low market prices of the Company's Common Stock on the date of grant (the "Market Price").

Options vest over a period of time determined by the Committee, generally on a pro rata basis over a four-year period.

Options vest over a period of time determined by the Committee, generally on a

pro rata basis over a four-year period.

The Committee also determines the expiration date of each option.

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The Company satisfies stock option exercises with newly issued shares of the Company's Common Stock.

The total intrinsic value of stock options exercised during 2021, 2020, and 2019 was $ 1.707 billion, $ 2.251 billion, and $ 558.9 million, respectively.

The total intrinsic value of stock options exercised during 2022, 2021, and 2020 was $ 1.214 billion, $ 1.707 billion, and $ 2.251 billion, respectively.

The intrinsic value represents the amount by which the market price of the underlying stock exceeds the exercise price of an option.

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Exercise price equal to Market Price 2.9 $ 492.60 $ 126.50

For the years ended December 31, 2021, 2020, and 2019, the Company recognized $ 328.7 million, $ 329.5 million, and $ 422.8 million, respectively, of non-cash stock-based compensation expense related to stock option awards (net of amounts capitalized as inventory, which were not material for each of the three years).

For the years ended December 31, 2022, 2021, and 2020, the Company recognized $ 341.9 million, $ 328.7 million, and $ 329.5 million, respectively, of stock-based compensation expense related to stock option awards (net of amounts capitalized as inventory, which were not material for each of the three years).

As of December 31, 2022, there was $ 572.0 million of stock-based compensation cost related to unvested stock options, net of estimated forfeitures, which had not yet been recognized.

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Date Fair Value

Balance as of December 31, 2020 1.7 $ 421.58

Unvested as of December 31, 2021 2.1 $ 499.85

Granted 0.9 $ 702.32

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Forfeited ( 0.1 ) $ 522.18

Balance as of December 31, 2021 2.1 $ 499.85

The Company recognized non-cash stock-based compensation expense related to restricted stock of $ 221.0 million, $ 102.5 million, and $ 29.7 million in 2021, 2020, and 2019, respectively (net of amounts capitalized as inventory, which were not material for each of the three years).

As of December 31, 2021, there was $ 649.1 million of stock-based compensation cost related to

unvested restricted stock which had not yet been recognized.

Unvested as of December 31, 2022 2.6 $ 571.19

For the years ended December 31, 2022, 2021, and 2020, the Company recognized $ 331.1 million, $ 221.0 million, and $ 102.5 million, respectively, of stock-based compensation expense related to restricted stock (net of amounts capitalized as inventory, which were not material for each of the three years).

As of December 31, 2022, there was $ 907.7 million of stock-based

compensation cost related to unvested restricted stock which had not yet been recognized.

The Company expects to recognize this compensation cost over a weighted-average period of 2.1 years.

Performance-based Restricted Stock Units

Performance-based restricted stock units ("PSUs") have been granted to certain executive officers of the Company.

The PSUs will be earned based upon the achievement of predetermined, cumulative total shareholder return goals with respect to the Company's Common Stock price over a specified (generally five-year ) period beginning on the grant date.

Performance-based restricted stock units ("PSUs") have been granted to certain members of senior management of the Company.

PSUs may be earned based upon the attainment of pre-established performance criteria, which may include a market and/or performance condition.

Depending on the terms of the PSUs and the outcome of the pre-established performance criteria, a recipient may ultimately earn the target number of PSUs granted or a specified multiple thereof at the end of a 4 – 6 year vesting period, as applicable.

The table below summarizes activity related to PSUs during 2022.

The number of PSUs granted represents the maximum number of units that are eligible to be earned.

Depending on the terms of the PSUs and the outcome of the performance goals, a recipient may ultimately earn 0 % to 250 % (as specified for each PSU grant) of the target number of PSUs granted.

As of December 31, 2021 and 2020, 1.3 million PSUs were outstanding with a weighted-average grant date fair value of $ 209.06 per unit.

During the year ended December 31, 2021, the Company did no t grant new PSUs and no PSUs were vested, forfeited, or cancelled.

The Company recognized non-cash stock-based compensation expense related to PSUs of $ 52.0 million and $ 11.7 million in 2021 and 2019, respectively.

The Company did no t recognize non-cash stock-based compensation expense related to PSUs in 2020 (as PSUs granted in 2020 were granted on December 31, 2020 and are expensed over the vesting period).

Number of Shares/Units

(In millions)

Weighted-Average Grant

Date Fair Value

Unvested as of December 31, 2021 1.3 $ 209.06

Granted 0.2 $ 485.61

Unvested as of December 31, 2022 1.5 $ 245.94

For each of the years ended December 31, 2022, and 2021, the Company recognized $ 52.0 million of stock-based compensation expense related to PSUs.

The Company did no t recognize stock-based compensation expense related to PSUs in 2020 (as PSUs granted in 2020 were granted on December 31, 2020 and are expensed over the vesting period).

As of December 31, 2022, there was $ 156.1 million of stock-based compensation cost related to unvested PSUs which had not yet been recognized.

The Company expects to recognize this compensation cost on a straight-line basis over a period of 4.0 years.

The Company expects to recognize this compensation cost on a straight-line basis over a weighted average period of 3.3 years.

Fair Value Assumptions:

The following table summarizes the weighted average values of the assumptions used in computing the fair value of PSUs that were granted during 2022 and 2020.

The Company did not grant PSUs during 2021.

Expected volatility 32 % 35 %

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The Company also maintains additional employee savings plans outside of the United States, which cover eligible employees.

Expenses recognized by the Company related to contributions to such plans were not material during 2021, 2020, and 2019.

Expenses recognized by the Company related to contributions to such plans were $ 67.6 million, $ 55.5 million, and $ 49.9 million for the years ended December 31, 2022, 2021, and 2020, respectively.

The Company is subject to U.S.

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Stock-based compensation ( 2.9 ) ( 2.4 ) ( 7.6 )

Foreign-derived intangible income deduction ( 1.4 ) — ( 1.6 )

Income tax credits ( 2.0 ) ( 1.0 ) ( 2.8 )

Foreign-derived intangible income deduction ( 1.0 ) ( 1.4 ) —

Sale of non-inventory related assets between foreign subsidiaries — — ( 0.8 )

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Deferred tax assets:

Capitalized research and development expenses $ 845.3 $ —

Deferred compensation 416.2 406.6

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Fixed assets and intangible assets 227.6 257.5

Deferred revenue 57.3 44.6

Tax attribute carryforwards 41.3 6.1

Other 15.9 10.8

Deferred revenue — 57.3

Total deferred tax assets 1,781.9 1,000.4

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The Company's income tax returns outside of the United States remain open to examination from 2018 to 2021.

T he United States and many states generally have statutes of limitation ranging from 3 to 5 years;

The United States and many states generally have statutes of limitation ranging from 3 to 5 years;

however, those statutes could be extended due to the Company's tax credit carryforward position.

In general, tax authorities have the ability to review income tax returns in which the statute of limitation has previously expired to adjust the tax credits generated in those years.

The amount of net unrecognized tax benefits that, if settled, would impact the effective tax rate is $ 373.7 million, $ 321.1 million, and $ 267.0 million as of December 31, 2022, 2021, and 2020, respectively.

The following table reconciles the beginning and ending amounts of unrecognized tax benefits.

The amount of unrecognized tax benefits that, if settled, would impact the effective tax rate is $ 410.9 million, $ 267.0 million, and $ 210.8 million as of December 31, 2021, 2020, and 2019, respectively.

(In millions) 2022 2021 2020

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Gross increases related to current year tax positions 136.9 182.3 76.6

Gross increases (decreases) related to prior year tax positions 2.9 7.2 ( 7.2 )

Gross (decreases) increases related to prior year tax positions ( 5.0 ) 2.9 7.2

Gross decreases due to settlements and lapse of statutes of limitations

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Balance as of December 31 $ 542.8 $ 410.9 $ 267.0

During 2021, the decreases in unrecognized tax benefits related to the Company's federal income tax returns for 2015 and 2016, as these audits are closed.

In 2022, 2021, and 2020, the increases in unrecognized tax benefits primarily related to the Company's calculation of certain tax credits and other items related to the Company's international operations.

During 2021, 2020, and 2019, interest expense related to unrecognized tax benefits recorded by the Company was not material.

The Company does not believe that it is reasonably possible that the resolution of tax exposures within the next twelve months would have a material impact on its unrecognized tax benefits as of December 31, 2021.

The decrease in unrecognized tax benefits in 2021 was related to the closing of audits for the Company's federal income tax returns for 2015 and 2016.

Interest expense related to unrecognized tax benefits was not material in 2022, 2021, and 2020.

The Company does not believe that it is reasonably possible that the resolution of tax exposures within the next twelve months would have a material impact on the consolidated financial statements as of December 31, 2022.

In August 2022, the Inflation Reduction Act of 2022 ("IRA") was signed into law in the United States.

The IRA created a new corporate alternative minimum tax of 15% on adjusted financial statement income and an excise tax of 1% of the value of certain stock repurchases.

The provisions of the IRA will be effective for periods beginning after December 31, 2022.

The enactment of the IRA did not result in any material adjustments to the Company's income tax provisions or net deferred tax assets as of December 31, 2022.

Legal Matters

From time to time, the Company is a party to legal proceedings in the course of the Company's business.

Costs associated with the Company's involvement in legal proceedings are expensed as incurred.

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 December 31, 2022 and 2021, the Company's accruals for loss contingencies were not material.

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.

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.

Proceedings Relating to Praluent (alirocumab) Injection

As described in greater detail below, the Company is currently a party to patent infringement actions initiated by Amgen Inc.

As described below, the Company is currently a party to patent infringement actions initiated by Amgen Inc.

(and/or its affiliated entities) against the Company and/or Sanofi (and/or the Company's and Sanofi's respective affiliated entities) in a number of jurisdictions relating to Praluent.

See Note 3 for a description of the Company's and Sanofi's arrangement regarding the costs resulting from or associated with such actions.

In addition, as described below, the Company filed a lawsuit against Amgen alleging that Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws.

United States

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Amgen also seeks a judgment of patent infringement of the asserted patents, monetary damages (together with interest), costs and expenses of the lawsuits, and attorneys' fees.

As described in greater detail under "Second Jury Trial and Appeal" below, on February 11, 2021, the Federal Circuit (as defined below) affirmed the lower court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.

First Jury Trial and Appeal.

The first jury trial in this litigation (the "First Trial") was held in the United States District Court for the District of Delaware (the "District Court") from March 8 to March 16, 2016.

During the course of the First Trial, the District Court ruled as a matter of law in favor of Amgen that the asserted patent claims were not obvious, and in favor of the Company and the Sanofi defendants that there was no willful infringement of the asserted patent claims by the Company or the Sanofi defendants.

On March 16, 2016, the jury returned a verdict in favor of Amgen in the First Trial, finding that the asserted claims of the '165 and '741 Patents were not invalid based on either a lack of written description or a lack of enablement.

On October 5, 2017, the United States Court of Appeals for the Federal Circuit (the "Federal Circuit") reversed in part the District Court's decision and remanded for a new trial on the issues of written description and enablement.

In addition, it affirmed the District Court's ruling that Amgen's patents were not obvious.

Second Jury Trial and Appeal.

On January 3, 2019, the District Court held oral argument in the remanded proceedings on the Company and the Sanofi defendants' motion for judgment on the pleadings regarding Amgen's willful infringement claim.

On January 18, 2019, the District Court entered an order (i) denying the Company and the Sanofi defendants' motion for summary judgment on validity, (ii) denying Amgen's motion for partial summary judgment on estoppel, and (iii) granting the Company and the Sanofi defendants' cross-motion for summary judgment on estoppel.

On February 8, 2019, the District Court granted the Company and the Sanofi defendants' motion for judgment on the pleadings, thereby dismissing Amgen's claim of willful infringement.

The second jury trial in this litigation (the "Second Trial") was held before the District Court in February 2019 to determine the validity of Amgen's asserted patent claims.

On February 25, 2019, the jury returned a verdict in the Second Trial generally in favor of Amgen, finding that two claims of the '165 Patent and one claim of the '741 Patent were not invalid.

The jury also found that two claims of the '165 Patent were invalid for lack of adequate written description while rejecting the lack of enablement challenges to those two claims.

On August 28, 2019, the District Court ruled as a matter of law that Amgen's asserted patent claims are invalid based on lack of enablement.

The District Court also conditionally denied the Company and the Sanofi defendants' motion for a new trial.

On October 23, 2019, Amgen filed a notice of appeal of the District Court's decision with the Federal Circuit.

An oral hearing before the Federal Circuit was held on December 9, 2020.

On February 11, 2021, the Federal Circuit affirmed the District Court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.

On April 14, 2021, Amgen filed a petition for a rehearing en banc, which was denied on June 21, 2021.

On November 18, 2021, Amgen filed a petition for writ of certiorari with the United States Supreme Court.

Injunctive Relief Proceedings.

On March 18, 2019, Amgen filed a renewed motion for a permanent injunction to prohibit the Company and the Sanofi defendants from Commercializing Praluent in the United States (a "Permanent Injunction"), and an oral hearing on this motion was held in June 2019.

Previously, the Federal Circuit stayed and then vacated a Permanent Injunction granted by the District Court in connection with the First Trial.

On August 28, 2019, the District Court dismissed as moot Amgen's renewed motion for a Permanent Injunction.

As previously reported, on February 11, 2021, the United States Court of Appeals for the Federal Circuit (the "Federal Circuit") affirmed the lower court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.

On April 14, 2021, Amgen filed a petition for a rehearing en banc with the Federal Circuit, which was denied on June 21, 2021.

On November 4, 2022, the United States Supreme Court granted Amgen's petition for writ of certiorari.

An oral hearing has been scheduled for March 27, 2023.

On May 27, 2022, the Company filed a lawsuit against Amgen 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, 2022, Amgen filed a motion to dismiss the complaint.

On August 11, 2022, Amgen filed a motion to stay these proceedings pending resolution of the patent litigation described in the preceding paragraph.

An oral hearing on Amgen's motion to dismiss and motion to stay has been scheduled for January 6, 2023.

Amgen has asserted European Patent No.

2,215,124 (the "'124 Patent"), which pertains to PCSK9 monoclonal antibodies, in the countries in Europe discussed below.

2,215,124 (the "'124 Patent"), which pertains to PCSK9 monoclonal antibodies, in certain countries in Europe.

In October 2020, the '124 Patent claims directed to compositions of matter and medical use relevant to Praluent were ruled invalid based on a lack of inventive step by the Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO").

This decision impacted each of the infringement proceedings based on the '124 Patent discussed below.

Amgen filed lawsuits in Germany, the United Kingdom, and France in July 2016, July 2016, and September 2016, respectively, against the Company and certain of Sanofi's affiliated entities for infringement of the relevant designation of the '124 Patent in each such jurisdiction;

and these lawsuits were dismissed in November 2020, September 2021, and June 2021, respectively.

Following the EPO's decision, each of the '124 Patent infringement proceedings initiated by Amgen against the Company and certain of Sanofi's affiliated entities in these countries was dismissed, including in Germany.

The dismissal in Germany followed an earlier finding of infringement and granting of an injunction, both of which were subsequently overturned.

In December 2019, Amgen also filed lawsuits in the Netherlands, Italy, and Spain for infringement of the relevant designation of the '124 Patent in each such jurisdiction;

the Company was not named as a defendant in any of these actions, and each of these lawsuits was dismissed in February 2021.

As previously reported, on March 31, 2020, Amgen filed a lawsuit in the Tokyo District Court against Sanofi K.K.

seeking damages incurred by Amgen as a result of the earlier finding of infringement of Amgen's Japanese Patent Nos.

5,906,333 and 5,705,288 by the Tokyo District Court Civil Division.

The Company has not been named as a defendant in this damages action.

As a result of the overturned injunction in Germany discussed in the preceding sentence, the Company and/or certain of Sanofi's affiliated entities are seeking damages caused by Amgen's enforcement of the injunction.

As part of its opposition to these damages claims, on March 23, 2022, Amgen filed a counterclaim that asserted the German designation of European Patent No.

2,641,917 (the "'917 Patent") and seeks, among other things, a judgment of patent infringement, injunctive relief, and monetary damages.

The '917 Patent is a divisional patent of the '124 Patent discussed above (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent but contains claims to a different invention).

The '917 Patent is also subject to opposition proceedings in the EPO, which were initiated by Sanofi on May 5, 2021.

An oral hearing before the EPO has been scheduled for February 21, 2023.

Proceedings Relating to Dupixent (dupilumab) Injection

United States

On March 23, 2017, the Company, Sanofi-Aventis U.S.

LLC, and Genzyme Corporation initiated an inter partes review ("IPR") in the United States Patent and Trademark Office ("USPTO") seeking a declaration of invalidity of U.S.

8,679,487 (the "'487 Patent") owned by Immunex Corporation relating to antibodies that bind the human interleukin-4 receptor and subsequently filed two additional IPR petitions in the USPTO seeking declarations of invalidity of the '487 Patent based on different grounds (the "Additional IPR Petitions").

The Patent Trial and Appeal Board ("PTAB") of the USPTO issued a final written decision on the Additional IPR Petitions on February 14, 2019, invalidating all 17 claims of the '487 Patent as obvious.

This decision was subsequently affirmed by the Federal Circuit and Immunex's petition for writ of certiorari was denied by the United States Supreme Court.

The '487 Patent expired in May 2020 following Immunex's filing of a terminal disclaimer with the USPTO.

On April 5, 2017, Immunex Corporation filed a lawsuit against the Company, Sanofi, Sanofi-Aventis U.S.

LLC, Genzyme Corporation, and Aventisub LLC in the United States District Court for the Central District of California seeking a judgment of patent infringement of the '487 Patent and a declaratory judgment of infringement of the '487 Patent, in each case by the Company's and the other defendants' Commercializing of Dupixent;

monetary damages (together with interest);

an order of willful infringement of the '487 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.

The court subsequently granted a joint stipulation by the parties to stay the litigation pending resolution of the appeals of the PTAB's final written decisions on the Additional IPR Petitions discussed above;

and, on August 3, 2021, granted a motion to dismiss the lawsuit, dismissing all of Immunex's claims with prejudice.

On September 30, 2016, Sanofi initiated a revocation proceeding in the United Kingdom to invalidate the U.K.

counterpart of European Patent No.

2,292,665 (the "'665 Patent"), another patent owned by Immunex relating to antibodies that bind the human interleukin-4 receptor.

2,292,665 (the "'665 Patent"), a patent owned by Immunex Corporation relating to antibodies that bind the human interleukin-4 receptor.

At the joint request of the parties to the revocation proceeding, the U.K.

Patents Court ordered on January 30, 2017 that the revocation action be stayed pending the final determination of the currently pending EPO opposition proceedings initiated by the Company and Sanofi in relation to the '665 Patent.

Patents Court ordered on January 30, 2017 that the revocation action be stayed pending the final determination of the EPO opposition proceedings initiated

by the Company and Sanofi in relation to the '665 Patent.

The oral hearing before the EPO on the oppositions occurred on November 20, 2017, at which the claims of the '665 Patent were found invalid and the patent was revoked.

A final written decision of revocation of the '665 Patent was issued by the EPO on January 4, 2018.

Immunex filed a notice of appeal of the EPO's decision on January 31, 2018, and an oral hearing before the TBA has been scheduled for March 10–11, 2022.

Immunex filed a notice of appeal of the EPO's decision on January 31, 2018, which appeal was withdrawn at an oral hearing before the TBA on March 10, 2022 following the TBA's ruling discussed below.

On May 18, 2022, the revocation action in the U.K.

Patents Court was dismissed following the EPO's revocation of the '665 Patent.

On September 20, 2017 and September 21, 2017, respectively, the Company and Sanofi initiated opposition proceedings in the EPO against Immunex's European Patent No.

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The oral hearing before the EPO on the oppositions occurred on February 14–15, 2019, at which the '420 Patent was revoked in its entirety.

Immunex filed a notice of appeal of the EPO's decision on May 31, 2019, and an oral hearing before the TBA has been scheduled for March 10–11, 2022.

Immunex filed a notice of appeal of the EPO's decision on May 31, 2019.

At an oral hearing before the TBA on March 10, 2022, the TBA maintained the invalidity and revocation of the '420 Patent.

The original patent term of the Immunex patents expired in May 2021.

Proceedings Relating to EYLEA (aflibercept) Injection

On January 7, 2021, Chengdu Kanghong Pharmaceutical Group Co., Ltd.

("Chengdu Kanghong") filed an IPR petition in the USPTO against the Company' s U.S.

10,464,992 (the "'992 Patent") and a post-grant review ("PGR") petition against the Company's U.S.

10,828,345 (the "'345 Patent") seeking declarations of invalidity of the '992 Patent and '345 Patent.

On June 23, 2021, Chengdu Kanghong filed motions to dismiss each of these petitions and terminate the respective proceedings, which were granted by the USPTO on June 25, 2021.

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.

United States

On February 11, 2020, anonymous parties filed two requests for ex parte reexamination of the Company's U.S.

1 unchanged sentence

On May 5, 2021, Mylan Pharmaceuticals Inc.

filed IPR petitions in the USPTO against the Company's U.S.

filed inter partes review ("IPR") petitions in the USPTO against the Company's U.S.

9,254,338 (the "'338 Patent") and 9,669,069 (the "'069 Patent") seeking declarations of invalidity of the '338 Patent and the '069 Patent.

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and Celltrion, Inc.

each filed two separate IPR petitions against the Company's '338 and '069 Patents requesting that their IPRs be instituted and joined with the IPR proceedings initiated by Mylan concerning the '338 and '069 Patents.

An oral hearing was held on August 10, 2022.

On November 9, 2022, the USPTO issued final written decisions finding that the claims of the '338 and '069 Patents are unpatentable and, therefore, invalid.

On January 10, 2023, the Company filed notices of appeal of the USPTO written decisions concerning the '338 and '069 Patents with the Federal Circuit.

On September 7, 2021, Celltrion, Inc.

filed a PGR petition in the USPTO against the Company's U.S.

filed a post-grant review ("PGR") petition in the USPTO against the Company's U.S.

10,857,231 (the "'231 Patent") seeking a declaration of invalidity of the '231 Patent.

On March 14, 2022, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '231 Patent.

As a result, on March 15, 2022, the USPTO denied institution of Celltrion's PGR petition.

In 2022, Mylan filed IPR petitions against the Company's U.S.

10,130,681 (the "'681 Patent") and 10,888,601 (the "'601 Patent") (each filed July 1, 2022) and 10,857,205 (filed October 28, 2022) seeking declarations of invalidity of each of these patents.

On January 11, 2023, the USPTO instituted IPR proceedings concerning the '681 Patent and the '601 Patent.

On January 6, 2023, Samsung Bioepis Co., Ltd.

filed a separate IPR petition against the Company's '681 Patent seeking a declaration of invalidity of the '681 Patent.

On September 9, 2022, Apotex filed an IPR petition against the Company's U.S.

11,253,572 (the "'572 Patent") seeking a declaration of invalidity of the '572 Patent.

On January 17, 2023, Celltrion, Inc.

filed an IPR petition against the '992 Patent seeking a declaration of invalidity of the '992 Patent.

On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for a U.S.

Food and Drug Administration approval of an aflibercept biosimilar infringes certain Company patents.

A trial has been scheduled to begin on June 12, 2023.

On October 26 and October 27, 2021, anonymous parties initiated opposition proceedings in the EPO against the Company's European Patent No.

2,944,306 (the "'306 Patent") seeking revocation of the '306 Patent in its entirety.

On June 15, July 15, August 30, and October 4, 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 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).

A trial for the lawsuit concerning the '510 Patent and the '276 Patent has been scheduled for March 2024;

a trial for the lawsuit concerning the '193 Patent has been scheduled for May 2024;

and a trial for the lawsuit concerning the '495 Patent and the '768 Patent has been scheduled for November/December 2024.

The filing of the lawsuit concerning the '510 Patent and the '276 Patent resulted in a statutory 24-month stay of regulatory approval of Viatris Canada's aflibercept biosimilar in Canada unless the lawsuit is resolved earlier.

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.

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

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9,220,631 (the "'631 Patent").

Novartis also requested a permanent limited exclusion order forbidding entry into the United States of EYLEA PFS or components thereof;

a permanent cease-and-desist order from the importation, sale, offer for sale, advertising, packaging, or solicitation of any sale by the Company of EYLEA PFS or components thereof;

and a bond should the Company continue to import EYLEA PFS (if found to infringe) during, if applicable, any 60-day Presidential review period (i.e., the period when the President of the United States (or his designee) can disapprove any ITC decision to issue an exclusion order or cease-and-desist order).

The ITC instituted the investigation on July 22, 2020 and a trial was scheduled for April 19–23, 2021.

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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 July 30, 2020, the court granted the Company's motion to stay these proceedings until a determination in the ITC proceedings discussed above, including any appeals therefrom, becomes final.

On June 11, 2021, the court, at the request of Novartis, lifted the stay.

On November 5, 2021, the Company filed a motion to stay these proceedings in light of the pending IPR proceeding discussed below.

On January 31, 2022, the court denied the Company's motion to stay these proceedings.

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.

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.

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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").

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As a result, this lawsuit was transferred to the same judge that had been assigned to the patent infringement lawsuit discussed above.

On November 5, 2021, the Company filed a motion to stay these proceedings in light of the pending IPR proceeding

discussed above.

On November 5, 2021, the Company filed a motion to stay these proceedings in light of the pending IPR proceeding discussed above.

On January 31, 2022, the court denied the Company's motion to stay these proceedings and granted Novartis and Vetter's motion to dismiss the amended complaint.

Proceedings Related to "Most Favored Nation" Interim Final Rule

On December 11, 2020, the Company filed a lawsuit in the United States District Court for the Southern District of New York against the U.S.

Department of Health and Human Services, the Secretary of HHS, the Centers for Medicare & Medicaid Services ("CMS"), and the Administrator of CMS seeking declaratory and injunctive relief related to the interim final rule with comment period entitled "Most Favored Nation (MFN) Model" issued on November 20, 2020 by HHS, acting through CMS (the "MFN Rule").

On the same day, the Company filed a motion for a preliminary injunction and temporary restraining order, seeking to prevent implementation of the MFN Rule.

On December 22, 2020, the court heard oral argument on the Company's motion for a preliminary injunction and temporary restraining order.

On December 31, 2020, the court granted the Company's motion and issued a preliminary injunction.

On February 2, 2021, the government stated to the court that the Solicitor General had determined not to appeal the preliminary injunction.

On February 10, 2021, the court entered a 90-day stay of the litigation and subsequently extended the stay, with the most recent 60-day extension granted on January 4, 2022.

On December 27, 2021, CMS published a final rule that rescinds the MFN Rule effective February 28, 2022.

Proceedings Relating to fasinumab

On May 21, 2020, the Company and Teva Pharmaceutical Industries Limited ("Teva") filed a lawsuit against Rinat Neurosciences Corp.

("Rinat"), a wholly owned subsidiary of Pfizer Inc., in the English High Court of Justice in London, seeking invalidation and revocation of Rinat's European Patent No.

2,270,048 (the "'048 Patent"), European Patent No.

1,871,416 (the "'416 Patent"), and European Patent No.

2,305,711 (the "'711 Patent"), each of which pertains to the use of NGF monoclonal antibodies to treat certain symptoms in patients suffering from osteoarthritis.

On July 21, 2020, Rinat filed its defense and counterclaim seeking a declaration of infringement of the '048 Patent by fasinumab.

The counterclaim also seeks a permanent injunction, damages, an accounting of profits, and costs and interest.

On December 15, 2020, Rinat filed an amended defense and counterclaim seeking a declaration of infringement of the '711 Patent by fasinumab.

On May 5, 2021, the court stayed this litigation on terms mutually agreed by the parties.

The '048 Patent is subject to opposition proceedings in the EPO, which were initiated by the Company on August 10, 2016 and two other opponents on August 11, 2016.

On January 3, 2018, the Opposition Division of the EPO issued a preliminary, non-binding opinion regarding the validity of the '048 Patent, indicating that it considered the granted patent to be invalid.

An oral hearing on the oppositions against the '048 Patent was held on November 29–30, 2018, at which the Opposition Division upheld the validity of the '048 Patent's claims in amended form.

The Company filed a notice of appeal to the TBA of the EPO on March 7, 2019.

On October 21, 2020, Teva filed a notice of intervention with the TBA to take part in the appeal proceedings as an intervener.

An oral hearing before the TBA has been scheduled for April 5–6, 2022.

The '711 Patent is also subject to opposition proceedings in the EPO, which were initiated by the Company on May 1, 2018.

On January 31, 2019, the Opposition Division of the EPO issued a preliminary, non-binding opinion regarding the validity of the '711 Patent, indicating that it considered the granted patent to be invalid.

An oral hearing on the opposition against the '711 Patent was held on December 3, 2019, at which the Opposition Division upheld the validity of the '711 Patent's claims in amended form.

The Company filed a notice of appeal to the TBA on December 20, 2019.

On January 29, 2021, Teva filed a notice of intervention with the TBA to take part in the appeal proceedings as an intervener.

An oral hearing before the TBA was held on July 29, 2021, at which the '711 Patent was revoked in its entirety.

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.

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) against the Company in the United States District Court for the Southern District of New York, asserting infringement of U.S.

("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.

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.

An oral hearing has been scheduled for March 2, 2022.

On July 16, 2021, the Company filed a motion to dismiss the complaint, which motion was denied on March 2, 2022.

Department of Justice Matters

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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.

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.

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On 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 the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law.

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.

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The Company is cooperating with this investigation.

Proceedings Initiated by UnitedHealthcare

On December 17, 2020, UnitedHealthcare Insurance Company and United Healthcare Services, Inc.

(collectively, "UHC") filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging UHC has been damaged by the conduct alleged in the civil complaint filed by the U.S.

Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.

UHC alleges causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act (the "RICO Act") and seeks monetary damages and equitable relief.

On March 1, 2021, the Company filed a motion to dismiss the complaint in its entirety.

On March 25, 2021, UHC filed an amended complaint;

and, on April 22, 2021, the Company filed a motion to dismiss this amended complaint in its entirety.

On December 29, 2021, this lawsuit was stayed pending resolution of the proceedings before the U.S.

District Court for the District of Massachusetts discussed under "Department of Justice Matters" above.

Proceedings Initiated by Humana

On July 22, 2021, Humana Inc.

("Humana") filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging Humana has been damaged by the conduct alleged in the civil complaint filed by the U.S.

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 civil complaint filed by the U.S.

Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.

Humana alleges causes of action under state law and the RICO Act and seeks monetary damages and equitable relief.

On September 27, 2021, the Company filed a motion to dismiss the complaint in its entirety.

On December 29, 2021, this lawsuit was stayed pending resolution of the proceedings before the U.S.

District Court for the District of Massachusetts discussed under "Department of Justice Matters" above.

Proceedings Initiated by Blue Cross and Blue Shield

On December 20, 2021, Blue Cross and Blue Shield of Massachusetts, Inc.

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") filed a lawsuit against the Company in the U.S.

District Court for the District of Massachusetts alleging BCBS has been damaged by the conduct alleged in the civil complaint filed by the U.S.

Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.

BCBS alleges causes of action under state law and the RICO Act and seeks monetary damages and equitable relief.

Shareholder Demand

On or about September 30, 2020, the Company's board of directors received a demand letter from a purported shareholder of the Company.

The demand alleges that Regeneron and its shareholders have been damaged by the conduct alleged in the civil complaint filed by the U.S.

(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 discussed under "Department of Justice Matters" above.

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 discussed under "Department of Justice Matters" above;

and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter.

Shareholder Demands

On or about September 30, 2020, March 30, 2022, and March 31, 2022, the Company's board of directors received three demand letters from purported shareholders of the Company.

The demands allege that Regeneron and its shareholders have been damaged by the conduct alleged in the civil complaint filed by the U.S.

Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.

The demand letter requests that the Company's board of directors investigate alleged breaches of fiduciary duty by its officers and directors and other alleged violations of law and corporate governance practices and procedures;

The demand letters request that the Company's board of directors investigate alleged breaches of fiduciary duty by its officers and directors and other alleged violations of law and corporate governance practices and procedures;

bring legal action against the persons responsible for causing the alleged damages;

and implement and maintain an effective system of internal controls, compliance mechanisms, and corporate governance practices and procedures.

The Company's board of directors, working with outside counsel, investigated and evaluated the allegations in the demand letter and has concluded that pursuing the claims alleged in the demand would not be in the Company's best interests at this time.

The Company's board of directors, working with outside counsel, investigated and evaluated the allegations in the demand letters and has concluded that pursuing the claims alleged in the demands would not be in the Company's best interests at this time.

Proceedings Relating to Shareholder Derivative Complaint

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District Court for the Southern District of New York.

On September 24, 2021, the individual defendants moved to dismiss the complaint in its entirety.

Also on September 24, 2021, the plaintiff filed a motion to remand the case to the New York Supreme Court.

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 discussed under "Department of Justice Matters" above.

As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice to renew upon conclusion of the stay.

Net Income Per Share

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Supplemental disclosure of non-cash investing and financing activities

Included in accounts payable, accrued expenses, and other liabilities as of December 31, 2021, 2020, and 2019 were $ 74.8 million, $ 83.6 million, and $ 133.7 million, respectively, of accrued capital expenditures.

As of December 31,

(In millions) 2022 2021 2020

Accrued capital expenditures $ 70.8 $ 74.8 $ 83.6

Accrued payments for Libtayo intangible asset $ 135.5 $ — $ —

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures