18 unchanged sentences
Other Information
+Added: As disclosed in the table below, during the three months ended December 31, 2023, certain of our directors and/or executive officers adopted plans for trading arrangements intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act.
+Added: Name Position Date of Plan Adoption Scheduled End Date of Trading Arrangement (a)
+Added: Total Number of Securities to Be Sold Under the Plan
+Added: Executive Vice President, Finance and Chief Financial Officer 11/9/2023 5/6/2024 14,337
+Added: (a) The trading arrangement may expire on an earlier date if and when all transactions under the arrangement are completed.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
17 unchanged sentences
Financial Statement Schedules
−Removed: All schedules for which provision is made in the applicable accounting regulations of the Securities and Exchange Commission are not required under the related instructions or are inapplicable and, therefore, have been omitted.
+Added: All schedules for which provision is made in the applicable accounting regulations of the SEC are not required under the related instructions or are inapplicable and, therefore, have been omitted.
Exhibit Number Description
4 unchanged sentences
(Incorporated by reference from the Form 8-K for the Registrant filed December 21, 2016.)
+Added: Amendment to the Amended and Restated By-Laws effective June 9, 2023.
+Added: (Incorporated by reference from the Form 8-K for the Registrant filed June 14, 2023.)
4.1 Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934.
33 unchanged sentences
(Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)
−Removed: 10.2.4 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P.
−Removed: Roy Vagelos, M.D.
−Removed: under the Regeneron Pharmaceuticals, Inc.
−Removed: 2014 Long-Term Incentive Plan.
−Removed: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2015, filed February 11, 2016.)
Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc.
10 unchanged sentences
(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.)
−Removed: 10.2.9 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P.
−Removed: Roy Vagelos, M.D.
−Removed: under the Amended and Restated Regeneron Pharmaceuticals, Inc.
−Removed: 2014 Long-Term Incentive Plan.
−Removed: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.)
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 Amended and Restated Regeneron Pharmaceuticals, Inc.
7 unchanged sentences
(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.)
−Removed: 10.2.13 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P.
−Removed: Roy Vagelos, M.D.
−Removed: under the Amended and Restated Regeneron Pharmaceuticals, Inc.
−Removed: 2014 Long-Term Incentive Plan (revised 2018).
−Removed: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.)
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 Amended and Restated Regeneron Pharmaceuticals, Inc.
10 unchanged sentences
(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)
−Removed: 10.2.18 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P.
−Removed: Roy Vagelos, M.D.
−Removed: under the Amended and Restated Regeneron Pharmaceuticals, Inc.
−Removed: 2014 Long-Term Incentive Plan (revised 2019).
−Removed: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)
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 Amended and Restated Regeneron Pharmaceuticals, Inc.
7 unchanged sentences
(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)
−Removed: 10.2.22 + Form of performance restricted stock unit award agreement and related notice of grant for use in connection with the grant of performance restricted stock units to Leonard S.
−Removed: Schleifer, M.D., Ph.D., George D.
−Removed: Yancopoulos, M.D., Ph.D., and P.
−Removed: Roy Vagelos, M.D.
−Removed: under the Amended and Restated Regeneron Pharmaceuticals, Inc.
−Removed: 2014 Long-Term Incentive Plan.
−Removed: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)
10.3 + Second Amended and Restated Regeneron Pharmaceuticals, Inc.
4 unchanged sentences
(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
−Removed: 10.3.2 + Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P.
−Removed: Roy Vagelos, M.D.
−Removed: under the Second Amended and Restated Regeneron Pharmaceuticals, Inc.
−Removed: 2014 Long-Term Incentive Plan.
−Removed: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
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 Second Amended and Restated Regeneron Pharmaceuticals, Inc.
1 unchanged sentence
(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
−Removed: 10.3.4 + Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to P.
−Removed: Roy Vagelos, M.D.
−Removed: under the Second Amended and Restated Regeneron Pharmaceuticals, Inc.
−Removed: 2014 Long-Term Incentive Plan.
−Removed: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Second Amended and Restated Regeneron Pharmaceuticals, Inc.
11 unchanged sentences
(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
+Added: Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc.
+Added: 2014 Long-Term Incentive Plan (revised 2023) .
+Added: Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restric ted stock awards to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc.
+Added: 2014 Long-Term Incentive Plan (revised 2023).
10.4 + Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S.
1 unchanged sentence
(Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2008, filed February 26, 2009.)
−Removed: 10.5* + Employment Agreement, dated as of December 31, 1998, between the Registrant and P.
−Removed: Roy Vagelos, M.D.
−Removed: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2004, filed March 11, 2005.)
+Added: Waiver and Consent, dated as of April 14, 2023, pursuant to the Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S.
+Added: Schleifer, M.D., Ph.D.
+Added: (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2023, filed August 3, 2023 .)
Offer Letter for Robert E.
7 unchanged sentences
(Incorporated by reference from the Form 8-K for the Registrant, filed June 17, 2015.)
+Added: First Amendment to Cash Incentive Bonus Plan.
+Added: (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2023, filed May 4, 2023.)
IL-1 Antibody Termination Agreement by and between Novartis Pharma AG, Novartis Pharmaceuticals Corporation and the Registrant, dated as of June 8, 2009.
29 unchanged sentences
(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2022, filed August 3, 2022.)
−Removed: 10.16* ANG2 License and Collaboration Agreement, dated as of March 23, 2016, by and between Bayer HealthCare LLC and the Registrant.
−Removed: (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2016, filed May 5, 2016.)
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.)
−Removed: 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.
+Added: Third Amended and Restated Participation Agreement, dated as of March 27, 2023, 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 29, 2023.)
−Removed: 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.
+Added: Third Amended and Restated Lease and Remedies Agreement, dated as of March 27, 2023, 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 29, 2023.)
−Removed: 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.
+Added: Third Amended and Restated Guaranty, dated as of March 27, 2023, 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 29, 2023.)
3 unchanged sentences
Form of License Agreement (Exhibit C to Master Agreement contained in Exhibit 10.19 ).
−Removed: 10.22** License Agreement, dated as of August 18, 2020, by and among the Registrant, F.
−Removed: Hoffman-La Roche Ltd, and Genentech, Inc.
−Removed: (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2020, filed November 5, 2020.)
+Added: Amendment No.
+Added: 1 to Master Agreement, dated as of April 10, 2023, by and between the Registrant and Alnylam Pharmaceuticals, Inc.
+Added: (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2023, filed August 3, 2023.)
21.1 Subsidiaries of the Registrant.
5 unchanged sentences
Section 1350.
+Added: Cl awback Policy.
101 Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"):
5 unchanged sentences
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
−Removed: * 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.
+Added: * Portions of this document have been omitted and filed separately with the SEC 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.
−Removed: 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.
+Added: The Registrant agrees to furnish supplementally a copy of all confidential portions of this Exhibit that were omitted to the SEC 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.
−Removed: 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.
+Added: The Registrant agrees to furnish supplementally a copy of all omitted exhibits and schedules of this Exhibit to the SEC upon its request.
+ Indicates a management contract or compensatory plan or arrangement.
8 unchanged sentences
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Leonard S.
−Removed: Schleifer, President and Chief Executive Officer, and Robert E.
−Removed: Landry, Executive Vice President, Finance and Chief Financial Officer, and each of them, his or her true and lawful attorney-in-fact and agent, with the full power of substitution and resubstitution, for him or her and in his or her name, place, and stead, in any and all capacities therewith, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that each said attorney-in-fact and agent, or either of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
+Added: Schleifer and Christopher Fenimore, and each of them, his or her true and lawful attorney-in-fact and agent, with the full power of substitution and resubstitution, for him or her and in his or her name, place, and stead, in any and all capacities therewith, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that each said attorney-in-fact and agent, or either of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:
1 unchanged sentence
/s/ LEONARD S.
−Removed: SCHLEIFER President, Chief Executive Officer, and Director (Principal Executive Officer) February 6, 2023
+Added: SCHLEIFER Board Co-Chair, President and Chief Executive Officer (Principal Executive Officer)
+Added: February 5, 2024
Schleifer, M.D., Ph.D.
1 unchanged sentence
LANDRY Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer) February 5, 2024
−Removed: /s/ CHRISTOPHER R.
−Removed: FENIMORE Senior Vice President, Controller (Principal Accounting Officer) February 6, 2023
−Removed: Christopher R.
+Added: /s/ CHRISTOPHER FENIMORE
+Added: Senior Vice President, Controller (Principal Accounting Officer) February 5, 2024
+Added: Christopher Fenimore
/s/ GEORGE D.
−Removed: YANCOPOULOS President, Chief Scientific Officer, and Director February 6, 2023
+Added: YANCOPOULOS Board Co-Chair, President and Chief Scientific Officer
+Added: February 5, 2024
Yancopoulos, M.D., Ph.D.
−Removed: ROY VAGELOS Chair of the Board of Directors February 6, 2023
−Removed: Roy Vagelos, M.D.
/s/ BONNIE L.
8 unchanged sentences
Goldstein, M.D.
+Added: /s/ KATHRYN GUARINI
+Added: February 5, 2024
+Added: Kathryn Guarini, Ph.D.
/s/ CHRISTINE A.
2 unchanged sentences
RYAN Director February 5, 2024
+Added: February 5, 2024
+Added: Schenkein, M.D.
/s/ GEORGE L.
SING Director February 5, 2024
−Removed: /s/ MARC TESSIER-LAVIGNE Director February 6, 2023
−Removed: Marc Tessier-Lavigne, Ph.D.
THOMPSON Director February 5, 2024
41 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.
−Removed: Accounting for the Acquisition of the Worldwide Rights to Libtayo
−Removed: 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.
−Removed: The transaction was accounted for as an asset acquisition.
−Removed: 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.
−Removed: 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.
−Removed: 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:
−Removed: royalties, which are recorded in the period in which the underlying sales occur;
−Removed: 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;
−Removed: a regulatory milestone of $ 100 million, which is recorded upon achievement;
−Removed: 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.
−Removed: 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.
+Added: Reserve for an Uncertain Tax Position
+Added: As described in Notes 1 and 15 to the consolidated financial statements, the Company's reserves for uncertain tax positions were $ 696.4 million as of December 31, 2023.
+Added: A reserve for an individual uncertain tax position represents a portion of the consolidated balance.
+Added: 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.
+Added: Uncertain tax positions are recorded based upon certain recognition and measurement criteria.
+Added: Management 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.
+Added: The Company adjusts the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions.
+Added: The principal considerations for our determination that performing procedures relating to the reserve for an uncertain tax position is a critical audit matter are (i) the significant judgment by management when determining the reserve for the uncertain tax position;
+Added: (ii) a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating management's determination of the reserve for the uncertain tax position;
+Added: (iii) the assessment and evaluation of audit evidence available to support the reserve for the uncertain tax position is complex, and (iv) 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.
−Removed: 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.
−Removed: 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;
−Removed: (ii) evaluating management's identification of the elements of the transaction;
−Removed: and (iii) evaluating the timing and recognition of contingent consideration.
−Removed: Professionals with specialized skill and knowledge were used to assist in evaluating the identification of the elements of the transaction.
+Added: These procedures included testing the effectiveness of controls relating to the recognition of reserves for uncertain tax positions.
+Added: These procedures also included, among others, (i) testing the information used in the calculation of the reserve for the individual uncertain tax position, such as international and federal filing positions, and the related final tax returns;
+Added: (ii) testing the calculation of the reserve for the uncertain tax position;
+Added: and (iii) evaluating management's assessment of the technical merits of tax positions and estimates of the amount of tax benefit expected to be sustained, as well as the likelihood of the possible outcome.
+Added: Professionals with specialized skills and knowledge were used to assist in evaluating the technical merits and the tax benefit expected to be sustained and the application of relevant tax laws.
/s/ PricewaterhouseCoopers LLP
22 unchanged sentences
Accrued expenses and other current liabilities 2,357.9 2,074.2
−Removed: Finance lease liabilities — 719.7
Deferred revenue 458.9 477.9
5 unchanged sentences
Total liabilities 7,107.1 6,550.5
−Removed: Commitments and contingencies (Note 11)
+Added: Commitments and contingencies
Stockholders' equity:
1 unchanged sentence
30.0 shares authorized;
−Removed: issued and outstanding - none
+Added: shares issued and outstanding - none
Class A Stock, convertible, par value $ .001 per share;
20 unchanged sentences
Net product sales $ 7,078.0 $ 6,893.7 $ 12,117.2
−Removed: Sanofi collaboration revenue 2,855.7 1,902.2 1,186.4
−Removed: Other collaboration revenue 2,058.4 1,771.1 1,186.1
+Added: Collaboration revenue
+Added: 5,503.1 4,914.1 3,673.3
Other revenue 536.1 365.1 281.2
22 unchanged sentences
Other comprehensive income (loss), net of tax:
−Removed: Unrealized (loss) gain on debt securities ( 213.6 ) ( 56.4 ) 9.1
−Removed: Unrealized gain (loss) on cash flow hedges 1.0 0.9 ( 0.9 )
+Added: Unrealized gain (loss) on debt securities
+Added: 158.2 ( 213.6 ) ( 56.4 )
+Added: Loss on foreign currency translation
+Added: Unrealized gain on cash flow hedges
Comprehensive income $ 4,111.5 $ 4,125.8 $ 8,019.8
2 unchanged sentences
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
−Removed: For the Years Ended December 31, 2022, 2021, and 2020
(In millions)
8 unchanged sentences
Net income — — — — — 8,075.3 — — — 8,075.3
−Removed: Other comprehensive income, net of tax — — — — — — 8.2 — — 8.2
+Added: 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
16 unchanged sentences
Net income — — — — — 3,953.6 — — — 3,953.6
−Removed: Other comprehensive loss, net of tax — — — — — — ( 212.6 ) — — ( 212.6 )
+Added: Other comprehensive income, net of tax
+Added: — — — — — — 157.9 — — 157.9
Balance, December 31, 2023
+Added: 1.8 $ — 133.1 $ 0.1 $ 11,354.0 $ 27,260.3 $ ( 80.9 ) ( 25.5 ) $ ( 12,560.4 ) $ 25,973.1
The accompanying notes are an integral part of the financial statements.
14 unchanged sentences
Changes in assets and liabilities:
−Removed: Decrease (increase) in accounts receivable 707.8 ( 1,927.4 ) ( 1,356.1 )
+Added: (Increase) decrease in accounts receivable
+Added: ( 338.8 ) 707.8 ( 1,927.4 )
Increase in inventories ( 271.7 ) ( 696.5 ) ( 494.3 )
−Removed: (Increase) decrease in prepaid expenses and other assets ( 148.6 ) ( 240.7 ) 114.9
+Added: Increase in prepaid expenses and other assets
+Added: ( 120.1 ) ( 148.6 ) ( 240.7 )
Increase (decrease) in deferred revenue 37.9 32.4 ( 120.2 )
−Removed: (Decrease) increase in accounts payable, accrued expenses, and other liabilities ( 138.4 ) 866.1 118.9
+Added: Increase (decrease) in accounts payable, accrued expenses, and other liabilities
+Added: 598.6 ( 138.4 ) 866.1
Total adjustments 640.4 676.5 ( 994.0 )
5 unchanged sentences
Payments for Libtayo intangible asset ( 207.8 ) ( 1,026.8 ) —
−Removed: Asset acquisition, net of cash acquired ( 230.3 ) — —
+Added: Acquisitions, net of cash acquired
+Added: ( 54.9 ) ( 230.3 ) —
Net cash used in investing activities ( 3,185.1 ) ( 3,784.6 ) ( 5,384.7 )
4 unchanged sentences
Repurchases of Common Stock ( 2,235.0 ) ( 2,082.8 ) ( 1,645.4 )
−Removed: Proceeds from issuance of long-term debt — — 1,981.9
−Removed: Proceeds from bridge loan facility — — 1,500.0
−Removed: Repayment of bridge loan facility — — ( 1,500.0 )
Net cash used in financing activities ( 1,790.1 ) ( 1,009.0 ) ( 1,005.8 )
−Removed: Net increase in cash, cash equivalents, and restricted cash 221.3 690.8 577.0
+Added: Effect of exchange rate changes on cash, cash equivalents, and restricted cash ( 0.4 ) — —
+Added: Net (decrease) increase in cash, cash equivalents, and restricted cash
+Added: ( 381.6 ) 221.3 690.8
Cash, cash equivalents, and restricted cash at beginning of period 3,119.4 2,898.1 2,207.3
9 unchanged sentences
Regeneron Pharmaceuticals, Inc.
−Removed: 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.
−Removed: 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.
−Removed: The Company currently has nine products that have received marketing approval by the U.S.
+Added: and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases.
+Added: The Company's products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.
+Added: The Company's research and development efforts have led to eleven products that have received marketing approval by the U.S.
Food and Drug Administration ("FDA").
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;
−Removed: with this EUA revision, REGEN-COV is not currently authorized for use in any U.S.
+Added: as a result, REGEN-COV is not currently authorized for use in any U.S.
states, territories, or jurisdictions.
5 unchanged sentences
Intercompany balances and transactions are eliminated in consolidation.
−Removed: 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.
−Removed: 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.
−Removed: Amounts recorded in this line item during the year ended December 31, 2022 would have historically been recorded to Research and development expenses.
−Removed: 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.
+Added: Certain reclassifications have been made to prior period amounts to conform with the current period's presentation.
Use of Estimates
4 unchanged sentences
In accordance with the Company's policies, the Company mandates asset diversification and monitors exposure with its counterparties.
−Removed: Concentrations of credit risk with respect to customer and collaborator accounts receivable are significant.
−Removed: As of December 31, 2022, two individual customers accounted for 86 % of the Company's net trade accounts receivable balances.
−Removed: Three individual customers accounted for 91 % (including 29 % related to the U.S.
−Removed: government) of the Company's net trade accounts receivable balances as of December 31, 2021.
+Added: Concentrations of credit risk with respect to collaborator (see Note 3) and customer accounts receivable are significant.
+Added: As of December 31, 2023 and 2022, two individual customers accounted for 83 % and 86 % of the Company's net trade accounts receivable balances, respectively.
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.
9 unchanged sentences
These assets are carried at fair value and the unrealized gains and losses are included in accumulated other comprehensive income (loss).
−Removed: Realized gains and losses on available-for-sale debt securities are included in other income (expense), net.
+Added: Realized gains and losses on available-for-sale debt securities are included in other income
+Added: (expense), net.
The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors.
30 unchanged sentences
Leases with an initial term of 12 months or less are not recorded on the balance sheet.
−Removed: The Company's lease terms may include options to extend or terminate a lease when it is reasonably certain that it will exercise that option.
+Added: The Company may include options to extend or terminate a lease within the lease term when it is reasonably certain that it will exercise that option.
The Company accounts for lease components (e.g., rental payments) separately from non-lease components (e.g., common area maintenance costs).
−Removed: 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 the Company is reasonably certain to exercise.
+Added: Lease liabilities are recognized at the lease commencement date based on the present value of the remaining lease payments, discounted using the rate implicit in the lease.
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.
+Added: The Company makes a determination whether a transaction should be accounted for as a business combination or as an asset acquisition.
+Added: In a business combination, the acquisition method of accounting generally requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values.
+Added: Amounts allocated to acquired in-process research and development are capitalized as indefinite-lived intangible assets.
+Added: Any excess of the purchase price (consideration transferred) over the fair values of net assets acquired is recorded as goodwill.
+Added: In a business combination, contingent consideration obligations are recorded at fair value as of the acquisition date and remeasured each subsequent reporting period until the contingencies have been resolved, with any changes in fair value recorded in Other operating (income) expense, net.
+Added: If it is determined that the assets acquired do not meet the definition of a business, or if substantially all of the fair value of the assets acquired are concentrated in a single identifiable asset, then the transaction is accounted for as an asset acquisition rather than a business combination.
+Added: In an asset acquisition, assets acquired are recorded at cost, goodwill is not recognized, and acquired in-process research and development with no alternative future use is charged to expense.
Intangible Assets
−Removed: The Company makes a determination of whether an asset or set of assets acquired constitute a business.
−Removed: 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.
−Removed: Intangible assets acquired in connection with an asset acquisition are recorded at cost.
−Removed: Such amounts may include up-front payments and contingent consideration.
−Removed: 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.
−Removed: 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;
−Removed: if that pattern cannot be reliably determined, a straight-line basis is used.
+Added: Intangible assets acquired in a business combination are recorded at fair value, while intangible assets acquired in connection with an asset acquisition are recorded at cost.
+Added: Payments to acquire intangible assets in an asset acquisition may include up-front payments and contingent consideration.
+Added: With regard to contingent consideration in an asset acquisition, 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.
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.
−Removed: 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.
+Added: Indefinite-lived intangible assets are subject to impairment testing until completion or abandonment of the associated research and development efforts.
+Added: Definite-lived 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;
+Added: if that pattern cannot be reliably determined, a straight-line basis is used.
+Added: 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.
−Removed: Revenue Recognition - Product Revenue
+Added: Product Revenue
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.
1 unchanged sentence
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.
−Removed: 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.
+Added: 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,
+Added: and other relevant factors.
The Company reviews its estimates of rebates, chargebacks, and other applicable provisions each period and records any necessary adjustments in the current period's net product sales.
1 unchanged sentence
The Company estimates reductions to product sales for each type of rebate and records an allowance for rebates in the same period in which the related product sales are recognized.
−Removed: The Company's liability for rebates consists of estimates for claims related to the current and prior periods that have not been paid and estimates for claims that will be made related to inventory that exists in the distribution channel at the end of the period.
+Added: The Company's liability for rebates consists of estimates for claims related to the current and prior periods that have not been paid and estimates for claims that will be made related to product that exists in the distribution channel at the end of the period.
• Chargebacks and Discounts:
17 unchanged sentences
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.
−Removed: 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.
+Added: 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.
+Added: In general, the presentation of such amounts is summarized below.
Nature/Type of Payment Statement of Operations Presentation
16 unchanged sentences
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
−Removed: 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
−Removed: promises should be combined as a single unit of account.
+Added: In agreements involving multiple goods or services promised to be transferred to the Company's collaborator, the Company assesses, 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.
12 unchanged sentences
Research and Development Expenses
−Removed: Research and development expenses include costs attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, depreciation on and maintenance of research equipment, costs related to research collaboration and licensing agreements, clinical trial expenses, the cost of services provided by outside contractors, including services related to the Company's clinical trials, the full cost of manufacturing drug for use in research and development, amounts that the Company is obligated to reimburse to collaborators for research and development expenses that they incur, and the allocable portions of facility costs.
+Added: Research and development expenses include costs attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, depreciation on and maintenance of research equipment,
+Added: costs related to research collaboration and licensing agreements, clinical trial expenses, the cost of services provided by outside contractors, including services related to the Company's clinical trials, the cost of manufacturing drug for use in research and development, amounts that the Company is obligated to reimburse to collaborators for research and development expenses that they incur, and the allocable portions of facility costs.
Costs associated with research and development are expensed.
16 unchanged sentences
Income taxes are accounted for under the liability method.
−Removed: Deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns, including deferred tax assets and liabilities for expected amounts of global intangible low-taxed income ("GILTI") inclusions, are recognized on the difference between the tax basis of assets and liabilities and their respective financial reporting amounts ("temporary differences") at enacted tax rates in effect for the years in which the differences are expected to reverse.
+Added: Deferred tax assets and liabilities are recognized for the expected future tax consequences of events that have been included in the financial statements or tax returns, including deferred tax assets and liabilities for expected amounts of global intangible low-taxed income ("GILTI") inclusions.
+Added: Deferred tax assets and liabilities are determined as the difference between the tax basis of assets and liabilities and their respective financial reporting amounts ("temporary differences") at enacted tax rates in effect for the years in which the differences are expected to reverse.
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.
1 unchanged sentence
Uncertain tax positions are recorded based upon certain recognition and measurement criteria.
−Removed: 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.
+Added: 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, the effective settlement of matters subject to audit, information obtained during in-process audit activities, 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 tax positions.
6 unchanged sentences
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.
+Added: Recently Issued Accounting Standards
+Added: In November 2023, the FASB issued Accounting Standards Update No.
+Added: 2023-07, Segment Reporting - Improvements to Reportable Segment Disclosures .
+Added: The amendments require disclosure of incremental segment information on an annual and interim basis.
+Added: The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in Accounting Standards Codification 280, Segment Reporting .
+Added: The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024.
+Added: The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.
+Added: In December 2023, the FASB issued Accounting Standards Update No.
+Added: 2023-09, Income Taxes - Improvements to Income Tax Disclosures .
+Added: The amendments require (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction.
+Added: The amendments are effective for annual periods beginning after December 15, 2024.
+Added: The Company does not expect the adoption of the amendments to have a significant impact on its financial statements.
Product Sales
4 unchanged sentences
5,719.6 6,264.6 5,792.3
−Removed: Praluent ®(c)
+Added: Total EYLEA HD and EYLEA U.S.
5,885.4 6,264.6 5,792.3
−Removed: REGEN-COV ®(d)
538.8 374.5 306.3
−Removed: ARCALYST ®(e)
+Added: Total Libtayo
863.1 447.5 306.3
+Added: 182.4 130.0 170.0
+Added: REGEN-COV ®(c)
+Added: 77.3 48.6 18.4
+Added: ARCALYST ®(d)
+Added: $ 7,078.0 $ 6,893.7 $ 12,117.2
(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.
2 unchanged sentences
(b) Rest of world ("ROW")
−Removed: (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.
−Removed: Previously, Sanofi recorded net product sales of Praluent in the United States.
−Removed: See Note 3 for further details.
−Removed: (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.
+Added: (c) 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.
−Removed: (e) Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States.
+Added: (d) 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.
4 unchanged sentences
2023 2022 2021
−Removed: Besse Medical, a subsidiary of AmerisourceBergen Corporation
+Added: Besse Medical, a subsidiary of Cencora, Inc.
51 % 55 % 30 %
13 unchanged sentences
$ 202.2 $ 77.2 $ 44.8 $ 324.2
+Added: 1,047.1 363.6 150.4 1,561.1
Credits/payments ( 1,034.7 ) ( 360.8 ) ( 127.6 ) ( 1,523.1 )
1 unchanged sentence
214.6 80.0 67.6 362.2
+Added: 1,537.3 431.1 141.1 2,109.5
Credits/payments ( 1,398.0 ) ( 399.7 ) ( 127.2 ) ( 1,924.9 )
1 unchanged sentence
353.9 111.4 81.5 546.8
+Added: 2,074.5 439.2 155.3 2,669.0
Credits/payments ( 1,972.7 ) ( 388.3 ) ( 157.5 ) ( 2,518.5 )
Balance as of December 31, 2023
+Added: $ 455.7 $ 162.3 $ 79.3 $ 697.3
Collaboration, License, and Other Agreements
2 unchanged sentences
(In millions) 2023 2022 2021
−Removed: Regeneron's share of profits in connection with commercialization of antibodies Sanofi collaboration revenue $ 2,082.0 * $ 1,363.0 $ 785.2
−Removed: Sales-based milestones earned Sanofi collaboration revenue $ 100.0 $ 50.0 $ 50.0
−Removed: Reimbursement for manufacturing of commercial supplies Sanofi collaboration revenue $ 633.7 $ 488.8 $ 368.0
−Removed: Other Sanofi collaboration revenue $ 28.7 $ — $ —
−Removed: 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
+Added: Regeneron's share of profits in connection with commercialization of antibodies Collaboration revenue
+Added: $ 3,136.5 $ 2,082.0 * $ 1,363.0
+Added: Sales-based milestones earned Collaboration revenue
+Added: $ 50.0 $ 100.0 $ 50.0
+Added: Reimbursement for manufacturing of commercial supplies Collaboration revenue
+Added: $ 613.0 $ 633.7 $ 488.8
+Added: Other Collaboration revenue
+Added: $ — $ 28.7 $ —
+Added: Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses (R&D expense)/Reduction of R&D expense $ ( 83.7 ) $ 43.0 $ 129.2
Reimbursement of commercialization-related expenses Reduction of SG&A expense $ 534.4 $ 437.4 $ 320.5
−Removed: Immuno-oncology ** :
−Removed: 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 )
+Added: Immuno-oncology (a) :
+Added: Regeneron's share of profits (losses) in connection with commercialization of Libtayo outside the United States Collaboration revenue
+Added: $ — $ 6.7 $ ( 13.6 )
Reimbursement for manufacturing of ex-U.S.
−Removed: commercial supplies Sanofi collaboration revenue $ 4.6 $ 14.0 $ 8.9
+Added: commercial supplies Collaboration revenue
+Added: $ — $ 4.6 $ 14.0
Reimbursement of R&D expenses Reduction of R&D expense $ — $ 42.7 $ 85.1
5 unchanged sentences
* Net of one-time payment of $ 56.9 million to Sanofi in connection with the amendment to the Antibody License and Collaboration Agreement
−Removed: ** 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
+Added: (a) 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.
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 ® (dupilumab), Kevzara ® (sarilumab), and itepekimab .
3 unchanged sentences
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 %.
−Removed: 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;
−Removed: this portion will be recorded as an increase to the Libtayo intangible asset over time as the Company repays such development costs to Sanofi.
−Removed: The Company's contingent reimbursement
−Removed: obligation (development balance) to Sanofi under the Antibody Collaboration was approximately $ 2.864 billion as of December 31, 2022.
+Added: 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 (cemiplimab) rights described within the " Immuno-Oncology " section below;
+Added: this portion is recorded as an increase to the Libtayo intangible asset over time as the Company repays such development costs to Sanofi.
+Added: The Company's contingent reimbursement obligation to Sanofi under the Antibody Collaboration was approximately $ 2.330 billion as of December 31, 2023.
Sanofi leads commercialization activities for products under the Antibody Collaboration, subject to the Company's right to co-commercialize such products.
The Company co-commercializes Dupixent in the United States and in certain countries outside the United States.
−Removed: The parties equally share profits and losses from sales within the United States.
−Removed: The parties share profits outside the United States on a sliding scale based on sales starting at 65 % (Sanofi)/ 35 % (Regeneron) and ending at 55 % (Sanofi)/ 45 % (Regeneron), and losses outside the United States at 55 % (Sanofi)/ 45 % (Regeneron).
−Removed: In addition to profit and loss sharing, the Company is entitled to receive sales milestone payments from Sanofi.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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;
−Removed: and providing commercial-related services, including the manufacturing of commercial supplies.
+Added: The parties equally share profits from sales within the United States.
+Added: The parties share profits outside the United States on a sliding scale based on sales starting at 65 % (Sanofi)/ 35 % (Regeneron) and ending at 55 % (Sanofi)/ 45 % (Regeneron).
+Added: In addition to profit sharing, the Company was entitled to receive sales milestone payments from Sanofi.
+Added: In 2023, the Company earned the final $ 50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent, which was previously included in the LCA) exceeding $ 3.0 billion on a rolling twelve-month basis.
+Added: In 2022, the Company earned two $ 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.
+Added: In 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 $ 1.5 billion, on a rolling twelve-month basis.
+Added: 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.
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.
−Removed: 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:
4 unchanged sentences
$ 427.7 $ 415.8
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The Company does not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States.
−Removed: 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.
−Removed: 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).
−Removed: The parties each bear 50 % of any damages arising out of Praluent sales or other activities prior to April 1, 2020.
−Removed: See Note 16 for discussion of legal proceedings related to Praluent.
Immuno-Oncology
4 unchanged sentences
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.
−Removed: During the first quarter of 2021, Sanofi did not exercise its options to license rights to these product candidates;
+Added: During 2021, Sanofi did not exercise its options to license rights to these product candidates;
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).
3 unchanged sentences
The parties shared equally, on an ongoing basis, development and commercialization expenses for Libtayo.
−Removed: 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.
+Added: The Company had principal control over the development of Libtayo and led commercialization activities in the United States, while Sanofi led commercialization activities outside the United States.
The parties shared equally in profits and losses in connection with the commercialization of Libtayo.
−Removed: 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").
+Added: Recognition of the up-front payments received from Sanofi had been deferred (recorded within Other liabilities), and such amounts were being recognized over the remaining period in which the Company was obligated to perform development activities.
+Added: 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.
+Added: In connection with the Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA") described below, 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 recorded in connection with the transaction during 2022.
+Added: Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under 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.
−Removed: 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).
+Added: In addition, Sanofi was eligible to earn an aggregate of $ 100.0 million in Libtayo sales-based milestones under the terms of the A&R IO LCA, of which they earned $ 65.0 million in 2022 and $ 35.0 million in 2023.
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.
−Removed: See Note 8 for additional information related to the intangible asset recorded in connection with the transaction.
+Added: See Note 8 for additional information related to the intangible asset.
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.
−Removed: The following table summarizes contract balances in connection with the Company's IO Collaboration with Sanofi:
−Removed: As of December 31,
−Removed: (In millions) 2022 2021
−Removed: Accounts receivable, net
−Removed: $ — $ ( 22.5 )
−Removed: Deferred revenue
−Removed: Other liabilities
−Removed: Other liabilities included up-front payments received from Sanofi for which recognition had been deferred.
−Removed: Such amounts were being recognized over the remaining period in which the Company was obligated to perform development activities.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: The Company's contingent reimbursement obligation to Sanofi under the A&R IO LCA was approximately $ 28 million as of December 31, 2023.
+Added: The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept) outside the United States.
Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally.
1 unchanged sentence
Within the United States, the Company is responsible for commercialization and retains profits from such sales.
−Removed: Bayer markets EYLEA outside the United States and the companies share equally in profits and losses from sales.
−Removed: 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.
+Added: Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.
+Added: 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 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.
3 unchanged sentences
(In millions) 2023 2022 2021
−Removed: 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
+Added: Regeneron's share of profits in connection with commercialization of EYLEA outside the United States Collaboration revenue
+Added: $ 1,376.4 $ 1,317.4 $ 1,349.2
Reimbursement for manufacturing of ex-U.S.
−Removed: commercial supplies Other collaboration revenue $ 91.4 $ 60.1 $ 78.2
−Removed: One-time payment in connection with change in Japan arrangement Other collaboration revenue $ 21.9 $ — $ —
−Removed: Reimbursement of R&D expenses Reduction of R&D expense $ 51.0 $ 46.1 $ 46.7
−Removed: Regeneron's obligation for its share of Bayer R&D expenses R&D expense $ ( 34.3 ) $ ( 40.9 ) $ ( 35.8 )
+Added: commercial supplies Collaboration revenue
+Added: $ 111.1 $ 91.4 $ 60.1
+Added: One-time payment in connection with change in Japan arrangement Collaboration revenue
+Added: $ — $ 21.9 $ —
+Added: Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses (R&D expense)/Reduction of R&D expense $ ( 44.0 ) $ 16.7 $ 5.2
The following table summarizes contract balances in connection with the Company's Bayer collaboration:
4 unchanged sentences
$ 138.2 $ 131.9
−Removed: In 2016, the Company entered into a license and collaboration agreement with Intellia Therapeutics, Inc.
−Removed: to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development.
−Removed: The parties collaborate to conduct research for the discovery, development, and commercialization of new therapies, in addition to the research and technology development of the CRISPR/Cas9 platform.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: In addition, the Company also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products.
−Removed: 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.
−Removed: 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.
−Removed: In 2020, the Company expanded its Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S.
−Removed: 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.
−Removed: In 2020, the Company also entered into an agreement with entities acting at the direction of BARDA and the U.S.
−Removed: Department of Defense to manufacture and deliver filled and finished drug product of REGEN-COV to the U.S.
−Removed: 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.
−Removed: In January 2021, the Company entered into an agreement with the U.S.
−Removed: Department of Defense and HHS to manufacture and deliver additional filled and finished drug product of REGEN-COV to the U.S.
−Removed: Pursuant to the agreement, the U.S.
−Removed: 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.
−Removed: In September 2021, the Company entered into an amendment to its January 2021 agreement to supply the U.S.
−Removed: government with an additional 1.4 million doses of REGEN-COV.
−Removed: Pursuant to the agreement, the U.S.
−Removed: 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.
−Removed: Roche supplied a portion of the doses to Regeneron to fulfill the Company's agreement with the U.S.
−Removed: government (see "Roche" below for further details regarding the Company's collaboration agreement with Roche).
−Removed: As of December 31, 2021, the Company had completed its final deliveries of drug product under the agreements described above.
−Removed: See Note 2 for REGEN-COV net product sales recognized during the years ended December 31, 2021 and 2020 in connection with these agreements.
−Removed: 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).
−Removed: Under the terms of the collaboration agreement, the Company leads global development activities for REGEN-COV, and the parties jointly fund certain studies.
−Removed: 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.
−Removed: 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.
−Removed: Each quarter, a single payment is due from one party to the other to true-up the global gross profits between the parties.
−Removed: If Regeneron is to receive a true-up payment from Roche, such amount will be recorded to Other collaboration revenue.
−Removed: If Regeneron is to make a true-up payment to Roche, such amount will be recorded to Cost of goods sold.
−Removed: Amounts recognized in the Company's Statements of Operations in connection with the Roche Collaboration Agreement are as follows:
+Added: In 2019, the Company and Alnylam Pharmaceuticals, Inc.
+Added: 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.
+Added: In connection with entering into 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.
+Added: For each program, the Company provides Alnylam with a specified amount of funding at program initiation and at lead candidate designation.
+Added: Under the terms of the collaboration, the parties perform discovery research until designation of lead candidates.
+Added: Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development/co-commercialization collaboration agreement (under which the parties are advancing ALN-APP and ALN-PNP, which are currently in clinical development) or a license agreement.
+Added: 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").
+Added: In addition, the Company has the option to extend the Research Term for an additional five-year period for a research extension fee of $ 300.0 million.
+Added: During 2023, the Company paid a $ 100.0 million development milestone to Alnylam, which was recorded to Acquired in-process research and development expense, upon the achievement of specified proof-of-principle criteria for the ALN-APP program.
+Added: Alnylam is eligible to receive an additional $ 100.0 million clinical proof-of-principle milestone in connection with an eye program.
+Added: Amounts recognized in the Company's Statements of Operations in connection with its Alnylam collaboration are as follows:
Statement of Operations Classification Year Ended December 31,
(In millions) 2023 2022 2021
−Removed: Global gross profit payment from Roche in connection with sales of REGEN-COV and Ronapreve Other collaboration revenue $ 627.3 $ 361.8 $ —
−Removed: Reimbursement of R&D expenses Reduction of R&D expense $ 6.8 $ 128.1 $ 78.5
−Removed: Global gross profit payment to Roche in connection with sales of REGEN-COV and Ronapreve Cost of goods sold $ — $ 259.6 $ —
−Removed: The following table summarizes contract balances in connection with the Roche Collaboration Agreement:
+Added: Regeneron's obligation for its share of Alnylam R&D expenses, net of reimbursement of R&D expenses
+Added: (R&D expense)
+Added: $ ( 74.1 ) $ ( 55.8 ) $ ( 60.5 )
+Added: Development milestone
+Added: Acquired in-process research and development $ ( 100.0 ) $ — $ —
+Added: The following table summarizes contract balances in connection with the Company's Alnylam collaboration:
As of December 31,
(In millions) 2023 2022
−Removed: Accounts receivable, net $ 396.6 $ —
Accrued expenses and other current liabilities
−Removed: In 2018, the Company and Alnylam Pharmaceuticals, Inc.
−Removed: 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).
−Removed: Under the terms of the collaboration agreement, the parties share development costs equally.
−Removed: During the fourth quarter of 2022, Alnylam elected to opt-out of further development activities related to ALN-HSD;
−Removed: 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).
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Under the collaboration, the parties plan to perform discovery research until designation of lead candidates.
−Removed: 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.
−Removed: 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").
−Removed: 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;
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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;
−Removed: as a result, Alnylam retains the right to develop and commercialize such product and the Company will receive a royalty on sales (if any).
−Removed: 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.
−Removed: In addition, contract balances in the Company's Balance Sheets were not material as of December 31, 2022 and 2021.
−Removed: In May 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc.
−Removed: (“Checkmate”) for a total equity value of approximately $ 250 million.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: Under the terms of the Teva Collaboration Agreement, the Company led global development activities and the parties share development costs equally.
−Removed: 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.
−Removed: Amounts recognized in the Company's Statements of Operations in connection with the Teva Collaboration Agreement are as follows:
+Added: The Company is a party to a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve ™ in other countries).
+Added: Under the terms of the collaboration agreement, the parties jointly fund certain studies, and the Company has the right to distribute the product in the United States while Roche has the right to distribute the product outside the United States.
+Added: 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.
+Added: Amounts recognized in the Company's Statements of Operations in connection with its Roche collaboration are as follows:
Statement of Operations Classification Year Ended December 31,
(In millions) 2023 2022 2021
−Removed: Amounts recognized in connection with up-front and development milestone payments received
−Removed: Other operating income
+Added: Global gross profit payment from Roche in connection with sales of REGEN-COV and Ronapreve Collaboration revenue
$ 224.3 $ 627.3 $ 361.8
−Removed: 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.
−Removed: Such amount was not material for the year ended December 31, 2022.
−Removed: The following table summarizes contract balances in connection with the Teva Collaboration Agreement:
+Added: Collaboration revenue
+Added: $ ( 13.3 ) $ — $ —
+Added: Reimbursement of R&D expenses
+Added: (R&D expense)/Reduction of R&D expense $ ( 1.5 ) $ 6.8 $ 128.1
+Added: Global gross profit payment to Roche in connection with sales of REGEN-COV and Ronapreve Cost of goods sold $ — $ — $ 259.6
+Added: The following table summarizes contract balances in connection with the Company's Roche collaboration:
As of December 31,
1 unchanged sentence
Accounts receivable, net $ — $ 396.6
−Removed: Other liabilities $ — $ 39.7
−Removed: Other liabilities included up-front and development milestone payments received from Teva for which recognition had been deferred.
−Removed: 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.
−Removed: 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.
+Added: In 2016, the Company entered into a license and collaboration agreement with Intellia Therapeutics, Inc.
+Added: to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development.
+Added: The parties collaborate to conduct research for the discovery, development, and commercialization of new therapies, in addition to the research and technology development of the CRISPR/Cas9 platform.
+Added: 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.
+Added: Certain targets that either the Company or Intellia selects may be subject to a co-development and co-commercialization arrangement at the Company's option or Intellia’s option, as applicable.
+Added: NTLA-2001, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia will lead development and commercialization activities and the parties share an agreed-upon percentage of development expenses and profits (if commercialized).
+Added: 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, with Regeneron leading development and commercialization activities.
+Added: In addition, the Company also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products.
+Added: In connection with the agreement, in 2020, the Company made a $ 70.0 million up-front payment.
+Added: In September 2023, the Company further expanded its existing collaboration to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases.
+Added: Intellia will lead the design of the editing methodology, the Company will lead the design of the targeted viral vector delivery approach, and the parties share costs equally.
+Added: Each company will have the opportunity to lead potential development and commercialization of product candidates for one target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target.
+Added: In October 2023, the Company elected to extend the period for selecting targets under the 2016 license and collaboration agreement for an additional two years until April 2026;
+Added: as a result, the Company became obligated to make a $ 30.0 million extension payment to Intellia (which was recorded to Acquired in-process research and development expense in 2023).
+Added: Amounts recognized in the Company's Statements of Operations in connection with research and development activities co-funded under the Intellia agreements were not material for the years ended December 31, 2023, 2022, and 2021.
+Added: In addition, contract balances in the Company's Balance Sheets in connection with the Intellia agreements were not material as of December 31, 2023 and 2022.
+Added: In March 2023, the Company and Sonoma Biotherapeutics, Inc.
+Added: entered into a license and collaboration agreement to bring together the Company's VelociSuite ® technologies with Sonoma's technology platform for the discovery, development, and commercialization of novel regulatory T cell ("Treg") therapies for autoimmune diseases.
+Added: In connection with the agreement, the Company made a $ 45.0 million up-front payment (which was recorded to Acquired in-process research and development expense in 2023) and, in April 2023, the Company purchased an aggregate of $ 30.0 million of Sonoma preferred stock.
+Added: Sonoma is also eligible to receive a $ 45.0 million development milestone payment.
+Added: The Company and Sonoma will co-fund research and development activities and share equally any future commercial expenses and profits.
+Added: The Company will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the United States.
+Added: Amounts recognized in the Company's Statements of Operations in connection with research and development activities co-funded under the Sonoma agreement were not material for the year ended December 31, 2023.
+Added: In addition, contract balances in the Company's Balance Sheets in connection with the Sonoma agreement were not material as of December 31, 2023.
+Added: In 2021, the Company entered into agreements with the U.S.
+Added: Department of Defense and the U.S.
+Added: Department of Health and Human Services ("HHS") to manufacture and deliver filled and finished drug product of REGEN-COV to the U.S.
+Added: Roche supplied a portion of the doses to Regeneron to fulfill the Company's agreement with the U.S.
+Added: government (see "Roche" above for further details regarding the Company's collaboration agreement with Roche).
+Added: As of December 31, 2021, the Company had completed its final deliveries of drug product under these agreements.
+Added: See Note 2 for REGEN-COV net product sales recognized during the year ended December 31, 2021 in connection with these agreements.
+Added: In August 2023, the Company expanded its Other Transaction Agreement ("OTA") with the Biomedical Advanced Research and Development Authority ("BARDA"), pursuant to which the HHS is obligated to fund up to 70 % of the Company's costs incurred for certain development activities related to a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.
+Added: Pursuant to the terms of the expanded agreement, the Company could receive payments of up to approximately $ 326 million in the aggregate to support clinical development, clinical manufacturing, and the regulatory licensure process.
+Added: Amounts recognized within Other revenue in the Company's Statements of Operations in connection with the expanded BARDA agreement were $ 50.4 million for the year ended December 31, 2023.
+Added: The following table summarizes the Company's contract balances in connection with this BARDA agreement:
+Added: As of December 31,
+Added: (In millions) 2023
+Added: Accounts receivable, net
+Added: In 2017, the Company entered into an agreement with Decibel Therapeutics, Inc.
+Added: to discover and develop new potential therapeutics to protect, repair and restore hearing (including DB-OTO, which is currently in clinical development, and preclinical programs for GJB2-related and stereocilin-related hearing loss).
+Added: In connection with the agreement, the Company also purchased shares of Decibel stock.
+Added: In August 2023, the Company entered into an Agreement and Plan of Merger to acquire Decibel, and in September 2023, the Company completed its acquisition of Decibel (which was accounted for as a business combination).
+Added: The Company paid $ 101.3 million in cash (or $ 4.00 per share of Decibel common stock), of which $ 6.6 million was attributed to post-combination services to be rendered by Decibel equity award holders, and as a result, was excluded from the amount of consideration transferred for purchase accounting.
+Added: In addition, Decibel shareholders received one non-tradeable contingent value right ("CVR") per share of Decibel common stock, which entitles the holder to receive up to $ 3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for DB-OTO within specified time periods.
+Added: At closing, the Company recorded a liability related to the fair value of the CVRs of $ 43.7 million (see Note 5).
+Added: The maximum aggregate amount that holders of the CVRs may be entitled to receive if all the milestones contemplated by the CVRs are achieved is approximately $ 97 million.
+Added: The fair value of the Company's investment in Decibel stock immediately before the acquisition date was $ 10.3 million.
+Added: The following table summarizes the amounts recognized for assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date:
+Added: September 25,
+Added: (In millions) 2023
+Added: Cash and cash equivalents $ 42.2
+Added: Marketable securities 12.1
+Added: Deferred tax assets, net
+Added: Indefinite-lived intangible asset related to in-process research and development 42.5
+Added: Other assets and liabilities, net
+Added: The final determination of fair values of assets acquired, liabilities assumed, and tax-related items will be completed no later than one year from the acquisition date.
+Added: In 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc.
+Added: for a total equity value of approximately $ 250 million.
+Added: As a result of the transaction, which was accounted for as an asset acquisition, the Company recorded, during 2022, (i) a charge of $ 195.0 million to Acquired in-process research and development and (ii) net assets of $ 61.7 million, including $ 26.4 million of cash and cash equivalents acquired, related to the assets acquired (including deferred tax assets and investments) and liabilities assumed.
+Added: In addition to the collaboration agreements discussed above, the Company has various other license and 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.
−Removed: 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.
−Removed: The payment or receipt of these amounts, however, is contingent upon the occurrence of various future events.
+Added: The Company has also 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.
+Added: As described above, as a result of obtaining worldwide rights to Libtayo, the Company pays Sanofi a royalty on net product sales of Libtayo.
+Added: In addition, in 2018, the Company and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E.
+Added: Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd.
+Added: 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.
+Added: Under the agreement, the Company paid royalties of 8.0 % on worldwide sales of Libtayo through December 31, 2023, and is obligated to pay royalties of 2.5 % from January 1, 2024 through December 31, 2026.
+Added: Prior to July 1, 2022, royalties on such sales were shared equally by the Company and Sanofi.
+Added: For the years ended December 31, 2023, 2022, and 2021, the Company recorded royalty expense (net of reimbursements from collaborators, as applicable) in its Statements of Operations of $ 117.6 million, $ 84.5 million, and $ 66.9 million, respectively, based on product sales under various licensing agreements.
Marketable Securities
19 unchanged sentences
The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates.
−Removed: The available-for-sale debt securities listed as of December 31, 2022 mature at various dates through April 2028.
+Added: The available-for-sale debt securities as of December 31, 2023 mature at various dates through April 2029.
The fair values of available-for-sale debt securities by contractual maturity consist of the following:
13 unchanged sentences
Sovereign bonds 12.4 ( 0.1 ) 44.8 ( 0.8 ) 57.2 ( 0.9 )
−Removed: Certificates of deposit 40.2 ( 0.1 ) — — 40.2 ( 0.1 )
+Added: Commercial paper
+Added: 636.8 ( 0.2 ) — — 636.8 ( 0.2 )
Asset-backed securities 61.8 ( 0.3 ) 25.3 ( 0.9 ) 87.1 ( 1.2 )
4 unchanged sentences
Sovereign bonds 18.6 ( 1.1 ) 45.6 ( 1.9 ) 64.2 ( 3.0 )
−Removed: Commercial paper 295.7 ( 0.1 ) — — 295.7 ( 0.1 )
Certificates of deposit 40.2 ( 0.1 ) — — 40.2 ( 0.1 )
1 unchanged sentence
$ 3,300.9 $ ( 76.9 ) $ 4,332.2 $ ( 225.9 ) $ 7,633.1 $ ( 302.8 )
−Removed: The unrealized losses on corporate bonds as of December 31, 2022 were primarily driven by increases in interest rates.
+Added: The unrealized losses on corporate bonds as of December 31, 2023 and 2022 were primarily driven by increased interest rates.
The Company has reviewed its portfolio of available-for-sale debt securities and determined that the decline in fair value below cost did not result from credit-related factors.
In addition, the Company does not intend to sell, and it is not more likely than not that the Company will be required to sell, such securities before recovery of their amortized cost bases.
−Removed: 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.
+Added: With respect to marketable securities, for the years ended December 31, 2023, 2022, and 2021, amounts reclassified from Accumulated other comprehensive loss into Other income (expense), net were related to realized gains/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, 2023, 2022, and 2021.
−Removed: 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.
+Added: The Company recognized interest income of $ 495.9 million, $ 160.1 million, and $ 45.8 million for the years ended December 31, 2023, 2022, and 2021, respectively, in Other income (expense), net.
Fair Value Measurements
−Removed: The table below summarizes the Company's assets which are measured at fair value on a recurring basis.
−Removed: The following fair value hierarchy is used to classify assets, based on inputs to valuation techniques utilized to measure fair value:
−Removed: • Level 1 - Quoted prices in active markets for identical assets
+Added: The table below summarizes the Company's assets and liabilities which are measured at fair value on a recurring basis.
+Added: The following fair value hierarchy is used to classify assets and liabilities, based on inputs to valuation techniques utilized to measure fair value:
+Added: • Level 1 - Quoted prices in active markets for identical assets or liabilities
• Level 2 - Significant other observable inputs, such as quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-based valuations in which significant inputs used are observable
1 unchanged sentence
(In millions) Fair Value Measurements at Reporting Date
−Removed: As of December 31, 2022 Fair Value Level 1 Level 2
+Added: As of December 31, 2023 Fair Value Level 1 Level 2 Level 3
+Added: Cash equivalents $ 928.1 $ 6.4 $ 921.7 $ —
Available-for-sale debt securities:
8 unchanged sentences
$ 14,439.4 $ 983.8 $ 13,455.6 $ —
+Added: Contingent consideration - CVRs
+Added: $ 43.7 $ — $ — $ 43.7
As of December 31, 2022
+Added: Cash equivalents $ 1,662.8 $ 88.3 $ 1,574.5 $ —
Available-for-sale debt securities:
9 unchanged sentences
The Company held certain restricted equity securities as of December 31, 2023 which are subject to transfer restrictions that expire at various dates throug h 2024 .
−Removed: 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.
−Removed: 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.
+Added: During the years ended December 31, 2023 and 2022, the Company recorded $ 237.8 million and $ 39.8 million, respectively, of net unrealized losses on equity securities in Other income (expense), net.
+Added: During the year ended December 31, 2021, the Company recorded $ 386.1 million of net unrealized gains on equity securities in Other income (expense), net.
+Added: In addition, during the year ended December 31, 2023, the Company recorded a write-down of $ 29.0 million in Other income (expense), net related to the Company's investments in private companies.
In addition to the investments summarized in the table above, as of December 31, 2023 and 2022, the Company had $ 74.3 million and $ 48.3 million, respectively, in equity investments that do not have a readily determinable fair value.
These investments are recorded within Other noncurrent assets.
+Added: As described in Note 3, in September 2023, the Company acquired Decibel and recorded a liability for the CVRs within other liabilities.
+Added: The fair value of the CVR liability is determined based on the probability of achieving certain clinical development and regulatory milestones and estimated discount rates.
+Added: Through December 31, 2023, there were no changes in the fair value of the CVRs subsequent to the date of acquisition.
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 $ 1.528 billion and $ 1.443 billion as of December 31, 2023 and 2022, respectively.
7 unchanged sentences
$ 2,580.5 $ 2,401.9
−Removed: Inventory balances in the table above are net of reserves of $ 720.7 million and $ 510.0 million as of December 31, 2022 and 2021, respectively.
Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred.
−Removed: 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.
−Removed: Inventory write-offs and reserves for the year ended December 31, 2020 were not material.
+Added: Inventory balances in the table above are net of reserves of $ 705.9 million and $ 720.7 million as of December 31, 2023 and 2022, respectively.
+Added: For the years ended December 31, 2023, 2022, and 2021, Cost of goods sold included inventory write-offs and reserves of $ 102.3 million, $ 258.7 million, and $ 457.1 million, respectively.
+Added: Inventory write-offs and reserves for the years ended 2022 and 2021 primarily related to REGEN-COV.
Property, Plant, and Equipment
−Removed: Property, plant, and equipment consists of the following:
+Added: Property, plant, and equipment, net consists of the following:
As of December 31,
(In millions) 2023 2022
−Removed: Land $ 264.5 $ 248.0
Building and improvements $ 2,423.1 $ 2,270.0
Leasehold improvements 133.9 114.3
−Removed: Construction in progress 980.5 767.7
Laboratory equipment 1,384.5 1,315.3
1 unchanged sentence
Furniture, office equipment, and other
+Added: Land 283.1 264.5
+Added: Construction in progress 1,345.0 980.5
6,125.2 5,432.2
−Removed: Less, accumulated depreciation and amortization
+Added: Accumulated depreciation and amortization
( 1,978.8 ) ( 1,669.2 )
4 unchanged sentences
Intangible Assets
−Removed: Intangible assets consist of the following:
+Added: Intangible assets.
+Added: net consist of the following:
As of December 31,
4 unchanged sentences
10.0 ( 6.3 ) 3.7 10.0 ( 5.1 ) 4.9
−Removed: Intangible assets, net $ 956.3 $ ( 40.8 ) $ 915.5 $ 29.3 $ ( 22.6 ) $ 6.7
−Removed: 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.
+Added: Acquired in-process research and development
+Added: 42.5 — 42.5 — — —
+Added: $ 1,171.6 $ ( 133.0 ) $ 1,038.6 $ 956.3 $ ( 40.8 ) $ 915.5
+Added: As described in Note 3, during the year ended December 31, 2023, the Company recorded an indefinite-lived intangible asset of $ 42.5 million in connection with its acquisition of Decibel.
+Added: During the year ended December 31, 2022, 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.
−Removed: 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.
−Removed: Amortization expense on intangible assets was $ 37.6 million for the year ended December 31, 2022.
−Removed: Amortization expense for the years ended December 31, 2021 and 2020 was not material.
+Added: Additionally, during the years ended December 31, 2023 and 2022, the Company recorded additions to the Libtayo intangible asset related to contingent consideration (including regulatory and sales-based milestones) due to Sanofi.
+Added: Amortization expense on intangible assets was $ 92.2 million and $ 37.6 million for the years ended December 31, 2023 and 2022, respectively.
+Added: Amortization expense for the year ended December 31, 2021 was no t material.
As of December 31, 2023, assuming no changes in the gross carrying amount of intangible assets, amortization expense is estimated to be approximately $ 85 million for each of the years ending December 31, 2024 through December 31, 2028.
6 unchanged sentences
Accrued sales-related costs 780.8 633.6
−Removed: Income taxes payable
−Removed: Amounts due to collaborators (see Note 3) 10.5 287.4
Other accrued expenses and liabilities
1 unchanged sentence
Credit Facility
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: 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 replaced the Company's then-existing 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.
−Removed: 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.
2 unchanged sentences
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.
−Removed: 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.
The Company had no borrowings outstanding under the 2022 Credit Facility as of December 31, 2023.
1 unchanged sentence
The Company was in compliance with all covenants of the 2022 Credit Agreement as of December 31, 2023.
−Removed: 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").
+Added: In 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.
7 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.
−Removed: 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.
+Added: Interest expense related to the Notes was $ 44.4 million in each of the years ended December 31, 2023, 2022, and 2021.
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.
1 unchanged sentence
The Notes also contain certain limitations on the Company's ability to incur liens and enter into sale and leaseback transactions, as well as customary events of default.
−Removed: Commitments and Contingencies
−Removed: See Note 16 for disclosures related to legal contingencies.
The Company conducts certain of its research, development, and administrative activities at leased facilities.
The Company also leases vehicles and other assets.
−Removed: Operating leases
−Removed: Amounts recognized in the Company's Consolidated Balance Sheets and Statements of Operations included in this report associated with operating leases were not material.
−Removed: 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.
−Removed: Finance leases
−Removed: 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").
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The agreements governing the Restated Lease financing contain financial and operating covenants.
−Removed: 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.
+Added: Tarrytown, New York Lease
+Added: The Company is party to a Third Amended and Restated Lease and Remedies Agreement (the "Third Amended and Restated Lease") with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital, LLC ("BAL"), as lessor, which relates to the Company’s lease of laboratory and office facilities in Tarrytown, New York (the “Facility”);
+Added: and a Third Amended and Restated Participation Agreement (the "Third Amended and Restated Participation Agreement") with Bank of America, N.A., as administrative agent (the "Administrative Agent"), and a syndicate of lenders (collectively with BAL, the "Participants"), as rent assignees.
+Added: The Third Amended and Restated Lease and Third Amended and Restated Participation Agreement provide for a March 2027 maturity date of the $ 720.0 million lease financing (previously advanced by the Participants in March 2017 in connection with the acquisition by BAL of the Facility and the Company's lease of the Facility from BAL) and the end of the term
+Added: of the Company's lease of the Facility from BAL, at which time all amounts outstanding thereunder will become due and payable in full.
+Added: In accordance with the terms of the Third Amended and Restated Lease, the Company pays all maintenance, insurance, taxes, and other costs arising out of the use of the Facility.
+Added: The Company is also required to make monthly payments of basic rent during the remaining term of the Third Amended and Restated Lease to satisfy the yield payable to the Participants on their outstanding advances under the Third Amended and Restated Participation Agreement.
+Added: Such advances accrue yield at a variable rate per annum based on the one-month forward-looking Secured Overnight Financing Rate ("SOFR") term rate, plus a spread adjustment, plus an applicable margin that varies with the Company's debt rating and total leverage ratio.
+Added: The Third Amended and Restated Participation Agreement and Third Amended and Restated Lease include an option for the Company to elect to further extend the maturity date of the Third Amended and Restated Participation Agreement and the term of the Third Amended and Restated Lease for an additional five-year period, subject to the consent of all the Participants and certain other conditions.
+Added: The Company also has the option prior to the end of the term of the Third Amended and Restated Lease to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Third Amended and Restated Participation Agreement, all accrued and unpaid yield thereon, and all other outstanding amounts under the Third Amended and Restated Participation Agreement, Third Amended and Restated Lease, and certain related documents or (b) sell the Facility to a third party on behalf of BAL.
+Added: The Third Amended and Restated Lease is 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.
+Added: The agreements governing the Third Amended and Restated Lease financing contain financial and operating covenants.
+Added: Such financial covenants and certain of the operating covenants are substantially similar to the covenants set forth in the 2022 Credit Agreement.
The Company was in compliance with all such covenants as of December 31, 2023.
−Removed: Amounts recognized in the Consolidated Balance Sheet related to the Lease are included in the table below.
−Removed: Other than the Lease described above, the Company had no leases accounted for as finance leases as of December 31, 2022 and 2021.
+Added: Aggregate Lease Information
+Added: Amounts recognized in the Consolidated Balance Sheet related to the Company's leases are included in the table below.
As of December 31,
2 unchanged sentences
$ 605.7 $ 620.3
−Removed: Finance lease liabilities Finance lease liabilities $ 720.0 $ 719.7
+Added: Operating lease right-of-use assets
+Added: Other noncurrent assets (b)
+Added: $ 683.7 $ 691.5
+Added: Finance lease liabilities - noncurrent
+Added: Finance lease liabilities $ 720.0 $ 720.0
+Added: Operating lease liabilities - current
+Added: Accrued expenses and other current liabilities
+Added: Operating lease liabilities - noncurrent
+Added: Other noncurrent liabilities
+Added: $ 807.7 $ 788.2
(a) Finance lease right-of-use assets were recorded net of accumulated amortization of $ 133.9 million and $ 119.4 million as of December 31, 2023 and 2022, respectively.
−Removed: Finance lease costs consist of the following:
+Added: (b) Operating lease right-of-use assets were recorded net of accumulated amortization of $ 44.6 million and $ 31.0 million as of December 31, 2023 and 2022, respectively.
+Added: Lease costs consist of the following:
Year Ended December 31,
(In millions) 2023 2022 2021
−Removed: Amortization of right-of-use assets $ 14.5 $ 14.4
−Removed: Interest on lease liabilities 21.6 11.9
+Added: Operating lease costs
$ 19.2 $ 12.4 $ 10.3
−Removed: Other information related to the Company's finance lease includes the following:
+Added: Finance lease costs:
+Added: Amortization of finance lease right-of-use assets 14.5 14.5 14.4
+Added: Interest on finance lease liabilities 45.0 21.6 11.9
+Added: Total finance lease costs
+Added: 59.5 36.1 26.3
+Added: Total lease costs
+Added: $ 78.7 $ 48.5 $ 36.6
+Added: Other information related to the Company's leases includes the following:
As of December 31,
−Removed: Remaining lease term (in years) 4.2 0.2
−Removed: Discount rate 4.84 % 1.68 %
−Removed: Supplemental information
−Removed: The following is a maturity analysis of the Company's finance lease liability:
−Removed: (In millions) As of December 31, 2022
+Added: Weighted-average remaining lease term (in years):
+Added: Finance leases
+Added: Operating leases
+Added: Weighted-average discount rate:
+Added: Finance leases
+Added: 5.08 % 4.84 %
+Added: Operating leases
+Added: 5.38 % 5.20 %
+Added: Supplemental cash flow information related to the Company's leases includes the following:
+Added: Year Ended December 31,
+Added: (In millions) 2023 2022 2021
+Added: Cash paid for amounts included in the measurement of operating lease liabilities (included within cash flows from operating activities)
+Added: $ 22.5 $ 7.7 $ 10.2
+Added: Right-of-use assets obtained in exchange for operating lease liabilities
+Added: $ 31.9 $ 35.1 $ 0.2
+Added: The following is a maturity analysis of the Company's lease liabilities as of December 31, 2023:
+Added: (In millions) Finance Leases
+Added: Operating Leases
+Added: 2024 $ 44.8 $ 24.1 $ 68.9
+Added: 2025 39.5 20.1 59.6
+Added: 2026 30.9 15.6 46.5
+Added: 2027 728.4 12.4 740.8
+Added: 2028 — 11.0 11.0
Total undiscounted lease payments 843.6 103.3 946.9
Imputed interest ( 123.6 ) ( 15.6 ) ( 139.2 )
−Removed: Total lease liability $ 720.0
−Removed: Research Collaboration and Licensing Agreements
−Removed: 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.
−Removed: 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.
−Removed: 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).
−Removed: 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.
−Removed: 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.
−Removed: See Note 3 for a more detailed description of collaboration, license, and other agreements.
−Removed: 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.
−Removed: In addition, in 2018, the Company and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E.
−Removed: Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd.
−Removed: 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.
−Removed: 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.
−Removed: Prior to July 1, 2022, royalties on such sales were shared equally by the Company and Sanofi.
−Removed: 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.
+Added: Total lease liabilities
+Added: $ 720.0 $ 87.7 $ 807.7
Stockholders' Equity
5 unchanged sentences
Share Repurchase Programs
−Removed: 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.
−Removed: 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.
−Removed: 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, the Company's board of directors authorized a share repurchase program to repurchase up to $ 1.5 billion of the Company's Common Stock.
−Removed: 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.
−Removed: 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.
−Removed: The share repurchase program was approved under terms substantially similar to the share repurchase programs described above.
+Added: In November 2021, the Company's board of directors authorized a share repurchase program to repurchase up to $ 3.0 billion of the Company's Common Stock.
+Added: As of June 30, 2023, the Company had repurchased the entire $ 3.0 billion of its Common Stock that it was authorized to repurchase under the program.
+Added: In January 2023, the Company's board of directors authorized an additional share repurchase program to repurchase up to $ 3.0 billion of the Company's Common Stock.
+Added: The share repurchase program permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.
+Added: Repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors.
The program has no time limit and can be discontinued at any time.
−Removed: As of December 31, 2022, $ 745.2 million remained available for share repurchases under the November 2021 program.
−Removed: 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.
+Added: There can be no assurance as to the timing or number of shares of any repurchases in the future.
+Added: As of December 31, 2023, $ 1.531 billion remained available for share repurchases under the program.
+Added: The table below summarizes the shares of the Company's Common Stock repurchased and the cost of the shares, which were recorded as Treasury Stock.
Year Ended December 31,
2 unchanged sentences
Total cost of shares $ 2,214.6 $ 2,099.8 $ 1,655.0
−Removed: 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.
−Removed: The share repurchase program was approved under terms substantially similar to the share repurchase programs described above.
−Removed: The program has no time limit and can be discontinued at any time.
−Removed: 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.
−Removed: Sanofi Funding of Certain Development Costs
−Removed: 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.
−Removed: 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.
−Removed: Consequently, the Company recorded the cost of the shares received, or $ 135.0 million, as Treasury Stock during 2020.
−Removed: Additional Stock Purchased from Sanofi
−Removed: 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.
−Removed: 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").
−Removed: 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).
−Removed: 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 Stock Purchase, 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.
−Removed: Arrangements with Other Collaborators
−Removed: 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).
−Removed: 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.
−Removed: 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).
−Removed: This prohibition will remain in place until the earliest of (i) the fifth anniversary of the expiration or earlier termination of the agreement or (ii) other specified events.
Long-Term Incentive Plans
−Removed: The Company has used long-term incentive plans for the purpose of granting equity awards to employees of the Company, including officers, and non-employees, including non-employee members of the Company's board of directors (collectively, "Participants").
+Added: The Company has used long-term incentive plans for the purpose of granting equity awards to employees of the Company, including officers, and non-employee members of the Company's board of directors (collectively, "Participants").
The Participants may receive awards as determined by a committee of independent members of the Company's board of directors or, to the extent authorized by such committee with respect to certain Participants, a duly authorized employee (collectively, the "Committee").
7 unchanged sentences
The awards that may be made under the Second Amended and Restated 2014 Incentive Plan include:
−Removed: (a) incentive stock options and non-qualified stock options, (b) restricted stock awards, (c) shares of phantom stock (also referred to as restricted stock units, which may be time- or performance-based), and (d) other awards.
+Added: (a) non-qualified stock options and incentive stock options, (b) restricted stock awards, (c) shares of phantom stock (also referred to as restricted stock units, which may be time- or performance-based), and (d) other awards.
Any award granted may (but is not required to) be subject to vesting based on the attainment by the Company of performance goals pre-established by the Committee.
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").
−Removed: Options vest over a period of time determined by the Committee, generally on a
−Removed: pro rata basis over a four-year period.
+Added: 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.
8 unchanged sentences
As of December 31, 2023, there were 14.6 million shares available for future grants under the Second Amended and Restated 2014 Incentive Plan.
−Removed: No additional awards may be made under the 2000 Incentive Plan, the Original 2014 Incentive Plan, or the Amended and Restated 2014 Incentive Plan.
Stock Options
−Removed: Transactions involving stock option awards during 2022 under the Company's Incentive Plans are summarized in the table below.
+Added: The table below summarizes the activity related to stock option awards under the Company's Incentive Plans during 2023.
Number of Shares
7 unchanged sentences
Exercised ( 2.8 ) $ 412.05
−Removed: Outstanding as of December 31, 2022 15.6 $ 481.62 6.3 $ 3,685.9
−Removed: Vested and expected to vest as of December 31, 2022 15.1 $ 476.15 6.2 $ 3,632.8
−Removed: Exercisable as of December 31, 2022 10.1 $ 420.47 5.0 $ 2,991.9
+Added: Outstanding as of December 31, 2023 14.2 $ 534.13 6.0 years $ 4,918.6
+Added: Vested and expected to vest as of December 31, 2023 13.8 $ 526.95 5.9 years $ 4,852.2
+Added: Exercisable as of December 31, 2023 9.6 $ 450.01 4.7 years $ 4,118.0
The Company satisfies stock option exercises with newly issued shares of the Company's Common Stock.
20 unchanged sentences
Expected lives are principally based on the Company's historical exercise experience with previously issued employee and board of directors' option grants.
−Removed: The expected dividend yield is zero as the Company has never paid dividends and does not currently anticipate paying any in the foreseeable future.
+Added: The expected dividend yield is zero as the Company has never paid dividends and does not currently have plans to do so.
The risk-free interest rates are based on quoted U.S.
12 unchanged sentences
For the years ended December 31, 2023, 2022, and 2021, the Company recognized $ 475.9 million, $ 331.1 million, and $ 221.0 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).
−Removed: As of December 31, 2022, there was $ 907.7 million of stock-based
+Added: As of December 31, 2023, there was $ 1.023 billion of stock-based
compensation cost related to unvested restricted stock which had not yet been recognized.
5 unchanged sentences
The table below summarizes activity related to PSUs during 2023.
−Removed: The number of PSUs granted represents the maximum number of units that are eligible to be earned.
+Added: The number of unvested PSUs represents the maximum number of units that are eligible to be earned.
Number of Shares/Units
3 unchanged sentences
Unvested as of December 31, 2022 1.5 $ 245.94
−Removed: Granted 0.2 $ 485.61
+Added: ( 0.1 ) $ 198.10
Unvested as of December 31, 2023 1.4 $ 247.91
For each of the years ended December 31, 2023, 2022, and 2021 the Company recognized $ 52.0 million of stock-based compensation expense related to PSUs.
−Removed: 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, 2023, there was $ 104.1 million of stock-based compensation cost related to unvested PSUs which had not yet been recognized.
1 unchanged sentence
Fair Value Assumptions:
−Removed: 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.
−Removed: The Company did not grant PSUs during 2021.
+Added: The following table summarizes the weighted average values of the assumptions used in computing the fair value of PSUs that were granted during 2022.
+Added: The Company did not grant PSUs during 2023 and 2021.
Expected volatility 32 %
7 unchanged sentences
In addition, the Company may make discretionary contributions, as defined, to the accounts of participants under the Savings Plan.
−Removed: The Company also maintains additional employee savings plans outside of the United States, which cover eligible employees.
+Added: The Company also maintains additional employee savings plans outside the United States, which cover eligible employees.
Expenses recognized by the Company related to contributions to such plans were $ 84.7 million, $ 67.6 million, and $ 55.5 million for the years ended December 31, 2023, 2022, and 2021, respectively.
17 unchanged sentences
Foreign 3.2 54.0 276.7
−Removed: Total deferred tax (benefit) expense ( 746.4 ) ( 147.1 ) 75.6
+Added: Total deferred tax benefit
( 837.8 ) ( 746.4 ) ( 147.1 )
+Added: $ 245.7 $ 520.4 $ 1,250.5
A reconciliation of the U.S.
8 unchanged sentences
Foreign-derived intangible income deduction ( 0.3 ) ( 1.0 ) ( 1.4 )
−Removed: Sale of non-inventory related assets between foreign subsidiaries — — ( 0.8 )
Other permanent differences ( 0.4 ) 1.1 —
11 unchanged sentences
Other 26.4 15.9
−Removed: Deferred revenue — 57.3
Total deferred tax assets 2,625.8 1,781.9
5 unchanged sentences
In general, the Company's state income tax returns from 2018 to 2022 remain open to examination.
−Removed: The Company's income tax returns outside of the United States remain open to examination from 2018 to 2021.
+Added: The Company's income tax returns outside the United States remain open to examination from 2018 to 2022.
The United States and many states generally have statutes of limitation ranging from 3 to 5 years;
1 unchanged sentence
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.
−Removed: 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:
2 unchanged sentences
Gross increases related to current year tax positions 153.4 136.9 182.3
−Removed: Gross (decreases) increases related to prior year tax positions ( 5.0 ) 2.9 7.2
−Removed: Gross decreases due to settlements and lapse of statutes of limitations
+Added: Gross increases (decreases) related to prior year tax positions
3.2 ( 5.0 ) 2.9
+Added: Gross decreases due to settlements and lapse of statutes of limitations ( 3.0 ) — ( 41.3 )
Balance as of December 31 $ 696.4 $ 542.8 $ 410.9
In 2023, 2022, and 2021, 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.
−Removed: 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.
+Added: In 2021, the decrease in unrecognized tax benefits due to settlements and lapse of statutes of limitations 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 2023, 2022, and 2021.
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, 2023.
+Added: The amount of net unrecognized tax benefits that, if settled, would impact the effective tax rate is $ 442.5 million, $ 373.7 million, and $ 321.1 million as of December 31, 2023, 2022, and 2021, respectively.
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.
−Removed: The provisions of the IRA will be effective for periods beginning after December 31, 2022.
−Removed: 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.
+Added: The provisions of the IRA became effective for periods beginning after December 31, 2022.
+Added: The IRA did not have a material impact on the Company's financial statements as of and for the periods ended December 31, 2023 and 2022.
Legal Matters
9 unchanged sentences
(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.
−Removed: 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.
+Added: 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 U.S.
+Added: federal and state laws.
United States
−Removed: In the United States, Amgen has asserted claims of U.S.
−Removed: 8,829,165 (the "'165 Patent") and 8,859,741 (the "'741 Patent"), and sought a permanent injunction to prevent the Company and the Sanofi defendants from commercial manufacturing, using, offering to sell, or selling within the United States (as well as importing into the United States) (collectively, "Commercializing") Praluent.
−Removed: 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.
+Added: In the United States, Amgen asserted claims of U.S.
+Added: 8,829,165 (the "'165 Patent") and 8,859,741 (the "'741 Patent"), and sought a permanent injunction to prevent the Company and the Sanofi defendants from commercial manufacturing, using, offering to sell, or selling within the United States (as well as importing into the United States) Praluent.
+Added: Amgen also sought a judgment of patent infringement of the asserted patents, monetary damages (together with interest), costs and expenses of the lawsuits, and attorneys' fees.
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.
1 unchanged sentence
On November 4, 2022, the United States Supreme Court granted Amgen's petition for writ of certiorari.
−Removed: An oral hearing has been scheduled for March 27, 2023.
+Added: An oral hearing was held on March 27, 2023.
+Added: On May 28, 2023, the United States Supreme Court affirmed the Federal Circuit's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.
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.
2 unchanged sentences
On August 11, 2022, Amgen filed a motion to stay these proceedings pending resolution of the patent litigation described in the preceding paragraph.
−Removed: An oral hearing on Amgen's motion to dismiss and motion to stay has been scheduled for January 6, 2023.
+Added: An oral hearing on Amgen's motion to dismiss and motion to stay was held on January 6, 2023.
+Added: On February 10, 2023, the court denied Amgen's motion to stay;
+Added: and on March 21, 2023, the court denied Amgen's motion to dismiss.
+Added: On August 28, 2023, the Company filed an amended complaint in this matter;
+Added: and, as part of its response, on September 20, 2023, Amgen filed a counterclaim alleging that the Company engaged in unfair business practices in violation of state law.
+Added: A trial has been scheduled to begin in November 2024.
Amgen has asserted European Patent No.
3 unchanged sentences
The dismissal in Germany followed an earlier finding of infringement and granting of an injunction, both of which were subsequently overturned.
−Removed: 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.
+Added: As a result of the overturned injunction in Germany, the Company and/or certain of Sanofi's affiliated entities are seeking damages caused by Amgen's enforcement of the injunction.
+Added: An oral hearing has been scheduled for February 28, 2024.
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.
1 unchanged sentence
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).
+Added: An oral hearing before the Munich Regional Court was held on November 29, 2023, at which Amgen's counterclaim was dismissed.
The '917 Patent is also subject to opposition proceedings in the EPO, which were initiated by Sanofi on May 5, 2021.
−Removed: An oral hearing before the EPO has been scheduled for February 21, 2023.
−Removed: Proceedings Relating to Dupixent (dupilumab) Injection
−Removed: On September 30, 2016, Sanofi initiated a revocation proceeding in the United Kingdom to invalidate the U.K.
−Removed: counterpart of European Patent No.
−Removed: 2,292,665 (the "'665 Patent"), a patent owned by Immunex Corporation relating to antibodies that bind the human interleukin-4 receptor.
−Removed: At the joint request of the parties to the revocation proceeding, the U.K.
−Removed: Patents Court ordered on January 30, 2017 that the revocation action be stayed pending the final determination of the EPO opposition proceedings initiated
−Removed: by the Company and Sanofi in relation to the '665 Patent.
−Removed: 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.
−Removed: A final written decision of revocation of the '665 Patent was issued by the EPO on January 4, 2018.
−Removed: 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.
−Removed: On May 18, 2022, the revocation action in the U.K.
−Removed: Patents Court was dismissed following the EPO's revocation of the '665 Patent.
−Removed: 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.
−Removed: 2,990,420 (the "'420 Patent"), a divisional patent of the '665 Patent (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '665 Patent but contains claims to a different invention).
−Removed: 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.
−Removed: Immunex filed a notice of appeal of the EPO's decision on May 31, 2019.
−Removed: At an oral hearing before the TBA on March 10, 2022, the TBA maintained the invalidity and revocation of the '420 Patent.
−Removed: The original patent term of the Immunex patents expired in May 2021.
+Added: An oral hearing before the EPO was held on February 21, 2023, at which the '917 Patent was revoked.
+Added: Amgen filed a notice to appeal to the TBA of the EPO on February 27, 2023.
+Added: On June 1, 2023, Amgen filed a lawsuit against the Company and certain of Sanofi's affiliated entities in the Munich Local Division of the Unified Patent Court (the "UPC") alleging infringement of Amgen's European Patent No.
+Added: 3,666,797 (the "'797 Patent").
+Added: The lawsuit seeks, among other things, a permanent injunction in several countries in Europe and monetary damages.
+Added: The '797 Patent is a divisional patent of the '124 Patent discussed above.
+Added: A trial has been scheduled for October 16–17, 2024.
+Added: Also on June 1, 2023, Sanofi filed an action in the Munich Central Division of the UPC seeking revocation of the '797 Patent.
+Added: A trial has been scheduled for June 4–5, 2024.
Proceedings Relating to EYLEA (aflibercept) Injection
2 unchanged sentences
United States
−Removed: On February 11, 2020, anonymous parties filed two requests for ex parte reexamination of the Company's U.S.
−Removed: 10,406,226 and 10,464,992 (the "'992 Patent"), and the USPTO has granted both requests to initiate reexamination proceedings.
−Removed: On May 5, 2021, Mylan Pharmaceuticals Inc.
−Removed: filed inter partes review ("IPR") petitions in the USPTO against the Company's U.S.
−Removed: 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.
−Removed: On November 10, 2021, the USPTO issued a decision instituting both IPR proceedings.
−Removed: On December 9, 2021, Apotex Inc.
−Removed: and Celltrion, Inc.
−Removed: 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, which petitions were granted on February 9, 2022.
−Removed: An oral hearing was held on August 10, 2022.
−Removed: 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.
+Added: Post-Grant Proceedings Before USPTO
+Added: Company Patent(s)
+Added: Challenger(s)
+Added: Type of Challenge
+Added: Date of Challenge
+Added: Latest Events/Current Status
+Added: 10,406,226 (the "'226 Patent") and 10,464,992 (the "'992 Patent") Anonymous parties Ex parte reexamination
+Added: February 11, 2020 On September 11, 2023, the USPTO dismissed the '226 Patent reexamination proceedings following the Company's filing of a Notice of Disclaimer, disclaiming all claims of the '226 Patent.
+Added: On September 8, 2023, the '992 Patent reexamination proceedings were stayed by the USPTO pending resolution of the inter partes review ("IPR") of the '992 Patent initiated by Celltrion, Inc., as discussed further below.
+Added: On January 17, 2024, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '992 Patent.
+Added: Company Patent(s) (continued)
+Added: Challenger(s)
+Added: Type of Challenge
+Added: Date of Challenge
+Added: Latest Events/Current Status
+Added: 9,254,338 (the "'338 Patent") and 9,669,069 (the "'069 Patent") Mylan Pharmaceuticals Inc., joined by Apotex Inc.
+Added: and Celltrion
+Added: IPR petitions seeking declarations of invalidity May 5, 2021 On November 9, 2022, the USPTO issued final written decisions finding that the challenged claims of the '338 and '069 Patents are unpatentable and, therefore, invalid.
On January 10, 2023, the Company filed notices of appeal of the USPTO written decisions concerning the '338 and '069 Patents with the Federal Circuit.
−Removed: On September 7, 2021, Celltrion, Inc.
−Removed: filed a post-grant review ("PGR") petition in the USPTO against the Company's U.S.
−Removed: 10,857,231 (the "'231 Patent") seeking a declaration of invalidity of the '231 Patent.
−Removed: On March 14, 2022, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '231 Patent.
−Removed: As a result, on March 15, 2022, the USPTO denied institution of Celltrion's PGR petition.
−Removed: In 2022, Mylan filed IPR petitions against the Company's U.S.
−Removed: 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.
−Removed: On January 11, 2023, the USPTO instituted IPR proceedings concerning the '681 Patent and the '601 Patent.
−Removed: On January 6, 2023, Samsung Bioepis Co., Ltd.
−Removed: filed a separate IPR petition against the Company's '681 Patent seeking a declaration of invalidity of the '681 Patent.
−Removed: On September 9, 2022, Apotex filed an IPR petition against the Company's U.S.
−Removed: 11,253,572 (the "'572 Patent") seeking a declaration of invalidity of the '572 Patent.
−Removed: On January 17, 2023, Celltrion, Inc.
−Removed: filed an IPR petition against the '992 Patent seeking a declaration of invalidity of the '992 Patent.
−Removed: 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.
−Removed: Food and Drug Administration approval of an aflibercept biosimilar infringes certain Company patents.
−Removed: A trial has been scheduled to begin on June 12, 2023.
−Removed: On October 26 and October 27, 2021, anonymous parties initiated opposition proceedings in the EPO against the Company's European Patent No.
−Removed: 2,944,306 (the "'306 Patent") seeking revocation of the '306 Patent in its entirety.
+Added: 10,130,681 (the "'681 Patent"), 10,888,601 (the "'601 Patent"), and 10,857,205 (the "'205 Patent") Mylan, joined by Celltrion ('601 and '681 Patents) and Samsung Bioepis Co., Ltd.
+Added: ('601 Patent)
+Added: IPR petitions seeking declarations of invalidity July 1, 2022 ('681 Patent and '601 Patent)
+Added: October 28, 2022 ('205 Patent)
+Added: On January 9, 2024, the USPTO issued final written decisions finding that that the challenged claims of the '681 and '601 Patents are unpatentable and, therefore, invalid.
+Added: On March 1, 2023, the USPTO denied institution of Mylan's IPR petition against the '205 Patent following the Company's filing of a Notice of Disclaimer with the USPTO, disclaiming all claims of the '205 Patent.
+Added: '681 Patent and '601 Patent
+Added: Samsung Bioepis, joined by Biocon Biologics Inc.
+Added: ('601 Patent)
+Added: IPR petitions seeking declarations of invalidity January 6, 2023 ('681 Patent)
+Added: March 26, 2023 ('601 Patent)
+Added: On July 19, 2023 and October 20, 2023, the USPTO instituted IPR proceedings concerning the '681 Patent and the '601 Patent, respectively.
+Added: 11,253,572 (the "'572 Patent") Apotex
+Added: IPR petition seeking declaration of invalidity
+Added: September 9, 2022
+Added: On March 10, 2023, the USPTO declined to institute an IPR proceeding based on the Apotex IPR petition.
+Added: Samsung Bioepis
+Added: IPR petition seeking declaration of invalidity
+Added: April 27, 2023
+Added: On November 17, 2023, the USPTO instituted IPR proceedings concerning the '572 Patent based on the Samsung IPR petition.
+Added: '992 Patent and '226 Patent
+Added: Celltrion, joined by Samsung Bioepis ('992 Patent)
+Added: IPR petitions seeking declarations of invalidity
+Added: January 17, 2023 ('992 Patent)
+Added: February 28, 2023 ('226 Patent)
+Added: On July 20, 2023, the USPTO instituted an IPR proceeding concerning the '992 Patent.
+Added: On January 17, 2024, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '992 Patent.
+Added: On September 1, 2023, the USPTO denied institution of Celltrion's IPR petition against the '226 Patent following the Company's filing of a Notice of Disclaimer with the USPTO, disclaiming all claims of the '226 Patent.
+Added: Patent Litigation
+Added: On August 2, 2022, the Company filed a patent infringement lawsuit against Mylan, a wholly-owned subsidiary of Viatris Inc., in the United States District Court for the Northern District of West Virginia alleging that Mylan's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.
+Added: On April 20, 2023, Mylan filed a motion for summary judgment or partial summary judgment concerning four of the asserted patents.
+Added: On April 26, 2023, the Company filed a stipulation accepting summary judgment of noninfringement of all asserted claims of the Company's U.S.
+Added: On June 5, 2023, Biocon, as successor-in-interest to the aflibercept 2 mg biosimilar, was joined as a defendant to the lawsuit.
+Added: A trial was held from June 12, 2023 through June 23, 2023 concerning certain claims of the '601 Patent, the '572 Patent, and the Company's U.S.
+Added: 11,084,865 (the "'865 Patent").
+Added: Closing arguments were presented on August 3, 2023.
+Added: On December 27, 2023, the court issued a decision finding that (i) the asserted claims of the '865 Patent were valid and infringed by Mylan and (ii) the asserted claims of the '601 and '572 Patents were infringed by Mylan but were invalid as obvious.
+Added: On November 8, November 22, and November 29, 2023, respectively, the Company filed patent infringement lawsuits against Celltrion, Samsung Bioepis, and Formycon AG in the United States District Court for the Northern District of West Virginia following service on Regeneron of each company's notice of commercial marketing.
+Added: The lawsuits allege that each company has infringed certain Company patents, including based on each company's filing for FDA approval of an aflibercept 2 mg biosimilar.
+Added: On December 27, 2023, the Company filed a second patent infringement lawsuit against Samsung Bioepis in the United States District Court for the Northern District of West Virginia alleging that Samsung's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.
+Added: A preliminary injunction hearing concerning each of these lawsuits has been scheduled for May 2, 2024.
+Added: On January 10, 2024, the Company filed a patent infringement lawsuit against Amgen in the United States District Court for the Central District of California alleging that Amgen's filing for FDA approval of an aflibercept 2 mg biosimilar infringes certain Company patents.
+Added: On January 11, 2024, the Company filed a motion with the United States Judicial Panel on Multidistrict Litigation seeking to transfer this lawsuit to the United States District Court for the Northern District of West Virginia for coordinated pretrial proceedings with the lawsuits described in the preceding paragraph.
+Added: A hearing on the motion to transfer has been scheduled for March 28, 2024.
+Added: Post-Grant Proceedings
+Added: Authority/Court
+Added: Company Patent(s)
+Added: Challenger(s)
+Added: Type of Challenge
+Added: Date of Challenge
+Added: Latest Events/Current Status
+Added: European Patent No.
+Added: 2,944,306 (the "'306 Patent") Anonymous parties Opposition proceedings October 26 and October 27, 2021 Oral hearing to be scheduled.
+Added: European Patent No.
+Added: 3,716,992 (the "EP '992 Patent") Amgen and three anonymous parties Opposition proceedings May 5-10, 2023 Oral hearing to be scheduled.
+Added: German Federal Patent Court
+Added: German designation of European Patent No.
+Added: 2,364,691 (the "'691 Patent") Samsung Bioepis NL B.V.
+Added: Invalidation proceedings June 22, 2023 Trial has been scheduled to begin in June 2025.
On June 15, July 15, August 30, and October 4, 2022, the Company and Bayer Inc.
−Removed: 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.
+Added: filed patent infringement lawsuits against BGP Pharma ULC d.b.a Viatris Canada ("Viatris Canada") in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's Canadian Patent Nos.
2,654,510 (the "'510 Patent") and 3,007,276 (the "'276 Patent") (in the lawsuit filed on June 15, 2022);
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3,129,193 (the "'193 Patent") (in the lawsuit filed on October 4, 2022).
−Removed: A trial for the lawsuit concerning the '510 Patent and the '276 Patent has been scheduled for March 2024;
+Added: A trial for the lawsuit concerning the '510 Patent and the '276 Patent (the "Viatris Canada 510/276 Lawsuit") 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.
−Removed: 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.
+Added: The filing of the Viatris Canada 510/276 Lawsuit resulted in a statutory 24-month stay of regulatory approval of Viatris Canada's aflibercept 2 mg
+Added: biosimilar in Canada unless the lawsuit is resolved earlier.
+Added: On March 27, 2023, in light of the transfer of Viatris Canada's New Drug Submission ("NDS") of its aflibercept 2 mg biosimilar to Biosimilar Collaborations Ireland Limited ("BCIL"), the Company filed a motion in the Federal Court of Canada seeking termination of the Viatris Canada 510/276 Lawsuit.
+Added: On June 5, 2023, BCIL was added as a defendant in the Viatris Canada 510/276 Lawsuit.
+Added: On March 23, 2023 and June 14, 2023, the Company and Bayer Inc.
+Added: filed patent infringement lawsuits against BCIL in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 and '276 Patents.
+Added: The June 14, 2023 lawsuit was filed after BCIL served Bayer Inc.
+Added: with a statutory notification in relation to the NDS on May 23, 2023.
+Added: On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Viatris Canada and BCIL in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of Bayer Healthcare LLC's Canadian Patent No.
+Added: 2,970,315 (the "'315 Patent").
+Added: On May 9, 2023, Amgen Canada Inc.
+Added: ("Amgen Canada") filed invalidation proceedings against the Company in the Federal Court of Canada seeking revocation of the '510 Patent and the '276 Patent.
+Added: On September 14, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '315 Patent.
+Added: On September 14, 2023, the Company and Bayer Inc.
+Added: filed three separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '193 Patent, '495 Patent, and '768 Patent, respectively.
+Added: On October 11, 2023, the Company, Bayer Inc., and Bayer Healthcare LLC filed two separate patent infringement lawsuits against Amgen Canada in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the Company's '510 Patent and '276 Patent, respectively.
+Added: A trial for the lawsuits concerning the '510 Patent and the '276 Patent has been scheduled for May 2025.
+Added: On January 15, 2024, the Company and Bayer Inc.
+Added: filed patent infringement lawsuits against Celltrion, Inc., Celltrion Healthcare Co, Ltd., Celltrion Pharma Inc., and Celltrion Healthcare Canada Ltd.
+Added: in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would directly or indirectly infringe one or more claims of the '510 Patent, the '276 Patent, the '495 Patent, the '768 Patent, the '193 Patent, and the '315 Patent.
On October 31, 2022 and December 13, 2022, Samsung Bioepis Co., Ltd.
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1131429 and 1406811, respectively, seeking revocation of each of such patents in its entirety.
−Removed: Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe
−Removed: On June 19, 2020, Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") filed a complaint with the U.S.
−Removed: International Trade Commission (the "ITC") pursuant to Section 337 of the Tariff Act of 1930 requesting that the ITC institute an investigation relating to the importation into the United States and/or sale within the United States after importation of EYLEA pre-filled syringes ("PFS") and/or components thereof which allegedly infringe Novartis’s U.S.
+Added: On January 16, 2023, the Company filed patent infringement lawsuits against Samsung Bioepis Co., Ltd.
+Added: and its parent company Samsung Biologics Co., Ltd.
+Added: before the Seoul Central District Court seeking a declaration that the making, constructing, using, or selling of an aflibercept 2 mg biosimilar would infringe one or more claims of the Company's Korean Patent No.
659477 (the "'477 Patent").
−Removed: The ITC instituted the investigation on July 22, 2020 and a trial was scheduled for April 19–23, 2021.
−Removed: On March 26, 2021, the staff attorney appointed by the ITC's Office of Unfair Import Investigations ("OUII")—an independent government party to the case representing the public interest—determined that the '631 Patent is invalid on several grounds.
−Removed: On April 8, 2021, Novartis moved to terminate the ITC investigation in its entirety based on its withdrawal of the complaint;
−Removed: and, on May 3, 2021, the ITC terminated the investigation.
−Removed: On June 19, 2020, Novartis also filed a patent infringement lawsuit (as amended on August 2, 2021) in the U.S.
−Removed: District Court for the Northern District of New York asserting claims of the '631 Patent and seeking preliminary and permanent injunctions to prevent the Company from continuing to infringe the '631 Patent.
−Removed: 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.
+Added: On July 20, 2023, the Company filed a preliminary injunction petition against Samsung Bioepis Co., Ltd.
+Added: and its parent company Samsung Biologics Co., Ltd.
+Added: before the Seoul Central District Court seeking a court order enjoining the manufacture, use, and assignment of an aflibercept 2 mg biosimilar that infringes one or more claims of the '477 Patent;
+Added: and on December 20, 2023, the Seoul Central District Court granted a preliminary injunction.
+Added: On January 10, 2024, the injunction was lifted against the Samsung entities following the expiration of the '477 Patent.
+Added: On March 2, 2023, the Company filed an affirmative scope confirmation action against Samsung Bioepis Co., Ltd.
+Added: before the Intellectual Property Tribunal and Appeal Board of the Korean Intellectual Property Office seeking a ruling that Samsung Bioepis's aflibercept 2 mg biosimilar is covered by the claims of the '477 Patent.
+Added: On March 7, 2023, the action was designated for expedited proceedings.
+Added: Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe
+Added: On June 19, 2020, Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") filed a patent infringement lawsuit (as amended on August 2, 2021) in the U.S.
+Added: District Court for the Northern District of New York asserting claims of Novartis's U.S.
+Added: 9,220,631 (the "'631 Patent") and seeking preliminary and permanent injunctions to prevent the Company from continuing to infringe the '631 Patent.
+Added: 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
+Added: lawsuits, and attorneys' fees.
On November 7, 2022, the Company and Novartis entered into a stipulation staying the lawsuit in light of the decision in the IPR proceeding discussed below.
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.
−Removed: On January 15, 2021, the USPTO declined to institute an IPR proceeding on procedural grounds in light of the pending ITC investigation discussed above;
−Removed: the other IPR petition has been withdrawn.
−Removed: Following Novartis's motion to terminate the ITC investigation discussed above, on April 16, 2021 the Company filed a new IPR petition seeking a declaration of invalidity of the '631 Patent based on the same grounds that were the basis for the OUII staff attorney's determination discussed above.
On October 26, 2021, the USPTO issued a decision instituting the IPR proceeding.
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Court of Appeals for the Second Circuit.
+Added: An oral hearing before the U.S.
+Added: Court of Appeals for the Second Circuit was held on October 11, 2023.
Proceedings Relating to REGEN-COV (casirivimab and imdevimab)
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On July 16, 2021, the Company filed a motion to dismiss the complaint, which motion was denied on March 2, 2022.
+Added: On September 18, 2023, the parties entered into a stipulation that narrowed the case to (i) whether any safe harbor defense under federal law applies to Regeneron's use of the invention covered, based on the court's claim construction, by the '221 Patent;
+Added: (ii) damages for any use by Regeneron found to not be covered by such safe harbor defense;
+Added: and (iii) whether any use referred to in clause (ii) above was willful.
Department of Justice Matters
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On January 31, 2023, the Company filed a motion for summary judgment.
+Added: An oral hearing on the parties' respective motions for summary judgment was held on July 21, 2023.
+Added: On September 27, 2023, the court (i) denied in part and granted in part the Company's motion for summary judgment and (ii) denied in its entirety the motion for partial summary judgment filed by the U.S.
+Added: Attorney's Office for the District of Massachusetts.
+Added: On October 25, 2023, the court certified for interlocutory appeal a portion of the court's September 27, 2023 order that addressed the causation standard applicable to the alleged violations of the federal Anti-Kickback Statute and federal False Claims Act;
+Added: and on December 11, 2023, the U.S.
+Added: Court of Appeals for the First Circuit certified for appeal the court's September 27, 2023 order.
In September 2019, the Company and Regeneron Healthcare Solutions, Inc., a wholly-owned subsidiary of the Company, each received a civil investigative demand ("CID") from the U.S.
Department of Justice pursuant to the federal False Claims Act relating to remuneration paid to physicians in the form of consulting fees, advisory boards, speaker fees, and payment or reimbursement for travel and entertainment allegedly in violation of the federal Anti-Kickback Statute.
−Removed: The CIDs relate to EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present.
+Added: The CIDs relate to
+Added: EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present.
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.
3 unchanged sentences
On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety.
+Added: On July 25, 2023, the court in part granted and in part denied the Company's motion to dismiss.
+Added: On September 1, 2023, the Company filed a second motion to dismiss the amended complaint or, in the alternative, a motion for judgment on the pleadings.
+Added: A trial has been scheduled for April 2025.
In June 2021, the Company received a CID from the U.S.
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The CID states that the investigation concerns allegations that the Company (i) violated the False Claims Act by paying kickbacks to distributors and ophthalmology practices to induce purchase of EYLEA, including through discounts, rebates, credit card fees, free units of EYLEA, and inventory management systems;
−Removed: and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to CMS.
+Added: and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to the Centers for Medicare & Medicaid Services.
The CID covers the period from January 2011 through June 2021.
The Company is cooperating with this investigation.
+Added: On November 29, 2023, the U.S.
+Added: Department of Justice informed the Company that it had filed a notice of partial intervention in this matter.
California Department of Insurance Subpoena
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and, in light of these stays, the parties to the Local 464A action have also agreed to stay that matter.
−Removed: Shareholder Demands
−Removed: 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.
−Removed: The demands allege that Regeneron and its shareholders have been damaged by the conduct alleged in the civil complaint filed by the U.S.
−Removed: Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.
−Removed: 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;
−Removed: bring legal action against the persons responsible for causing the alleged damages;
−Removed: and implement and maintain an effective system of internal controls, compliance mechanisms, and corporate governance practices and procedures.
−Removed: 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 District of Massachusetts discussed under "Department of Justice Matters" above.
−Removed: 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.
+Added: As a result of the stay, the court also terminated the Company's motion to dismiss the complaint without prejudice.
+Added: The Company can therefore renew the motion to dismiss upon conclusion of the stay.
Net Income Per Share
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Accrued capital expenditures $ 75.4 $ 70.8 $ 74.8
−Removed: Accrued payments for Libtayo intangible asset $ 135.5 $ — $ —
+Added: Accrued contingent consideration in connection with acquisitions
+Added: $ 71.6 $ 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.