12 unchanged sentences
There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
+Added: Inherent Limitations on Effectiveness of Controls
Our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls and procedures or internal controls over financial reporting will prevent all errors and all fraud.
3 unchanged sentences
OTHER INFORMATION
+Added: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
+Added: Not applicable.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
113 unchanged sentences
2014 Long-Term Incentive Plan (revised 2019).
−Removed: (Incorporated by reference from the F orm 10-K for the Registrant, for the year ended December 31, 201 9 , filed February 7, 20 20 .)
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)
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.
24 unchanged sentences
2014 Long-Term Incentive Plan.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021 .)
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.
2 unchanged sentences
2014 Long-Term Incentive Plan.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
10.3.3 + Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc.
2014 Long-Term Incentive Plan.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
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.
2 unchanged sentences
2014 Long-Term Incentive Plan.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
10.3.5 + 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.
2014 Long-Term Incentive Plan.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
10.3.6 + Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Second Amended and Restated Regeneron Pharmaceuticals, Inc.
2014 Long-Term Incentive Plan.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
10.3.7 + 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.
4 unchanged sentences
2014 Long-Term Incentive Plan.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
10.4 + Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S.
40 unchanged sentences
(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2020, filed August 5, 2020.)
+Added: 10.14.4** Fourth Amendment to Amended and Restated License and Collaboration Agreement, dated as of October 6, 2021, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi.
10.15** Praluent Cross License & Commercialization Agreement, dated as of April 5, 2020, and effective as of April 1, 2020, by and between the Registrant and Sanofi Biotechnology SAS.
17 unchanged sentences
(Incorporated by reference from the Form 8-K for the Registrant, filed December 17, 2018.)
+Added: 10.18.1 Amendment No.
+Added: 1 to Credit Agreement, dated as of November 11, 2021, by and among the Registrant, as a borrower and guarantor;
+Added: certain direct subsidiaries of the Registrant, as subsidiary borrowers;
+Added: JPMorgan Chase Bank, N.A., as administrative agent;
+Added: and the lenders party thereto.
10.19* Amended and Restated Immuno-oncology Discovery and Development Agreement, executed on January 2, 2019 and effective as of December 31, 2018, by and between the Registrant and Sanofi Biotechnology SAS.
2 unchanged sentences
(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)
+Added: 10.20.1** First Amendment to Immuno-oncology License and Collaboration Agreement, dated as of October 6, 2021, by and between the Registrant and Sanofi Biotechnology SAS.
10.21* Collaboration Agreement, dated as of September 29, 2015, by and between Regeneron Ireland and Mitsubishi Tanabe Pharma Corporation.
11 unchanged sentences
(Incorporated by reference from the Form 8-K for the Registrant, filed May 3, 2019.)
+Added: 10.25.1 First Amendment to Amended and Restated Participation Agreement, dated as of October 6, 2021, by and among Old Saw Mill Holdings LLC, as lessee;
+Added: the Registrant, as parent guarantor;
+Added: certain subsidiaries of the Registrant, as subsidiary guarantors;
+Added: BA Leasing BSC, LLC, as lessor;
+Added: Bank of America, N.A., as administrative agent;
+Added: and the lenders party thereto.
10.26 Amended and Restated Lease and Remedies Agreement, dated as of May 2, 2019, between Old Saw Mill Holdings LLC, as lessee, and BA Leasing BSC, LLC, as lessor.
17 unchanged sentences
10.34** Project Agreement, dated as of July 6, 2020, by and between the Registrant and Advanced Technology International.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
10.34.1 Modification No.
01 to Project Agreement, dated as of October 13, 2020, by and between the Registrant and Advanced Technology International.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
10.34.2** Modification No.
02 to Project Agreement, dated as of November 17, 2020, by and between the Registrant and Advanced Technology International.
+Added: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)
10.35** License Agreement, dated as of August 18, 2020, by and among the Registrant, F.
1 unchanged sentence
(Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2020, filed November 5, 2020.)
+Added: 10.36** Supply Agreement, dated as of January 12, 2021, by and between the Registrant and the U.S.
+Added: Army Contracting Command, New Jersey.
+Added: (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2021, filed May 6, 2021.)
+Added: 10.36.1** Modification P00004 to Supply Agreement, dated as of July 26, 2021, by and between the Registrant and the U.S.
+Added: Army Contracting Command, New Jersey.
+Added: (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2021, filed November 4, 2021.)
+Added: 10.36.2** Modification P00005 to Supply Agreement, dated as of September 14, 2021, by and between the Registrant and the U.S.
+Added: Army Contracting Command, New Jersey.
+Added: (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2021, filed November 4, 2021.)
21.1 Subsidiaries of the Registrant.
39 unchanged sentences
Yancopoulos, M.D., Ph.D.
−Removed: ROY VAGELOS Chairman of the Board February 8, 2021
+Added: ROY VAGELOS Chair of the Board of Directors February 7, 2022
Roy Vagelos, M.D.
20 unchanged sentences
INDEX TO FINANCIAL STATEMENTS
−Removed: Report of Independent Registered Public Accounting Firm
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID 238 )
Consolidated Balance Sheets as of December 31, 2021 and 2020
12 unchanged sentences
Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
−Removed: Changes in Accounting Principles
−Removed: As discussed in Note 1 to the consolidated financial statements, the Company changed the manner in which it accounts for amounts received from collaborative partners who are not deemed to be the Company's customers in 2020 and the manner in which it accounts for revenues from contracts with customers in 2018.
Basis for Opinions
14 unchanged sentences
A company's internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
−Removed: (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of
−Removed: financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;
+Added: (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;
and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.
4 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: Recognition of Other Operating Income related to Research and Development Up-front and Milestone Payments
+Added: Accounting for Other Operating Income related to Research and Development Up-front and Milestone Payments
As described in Note 1 to the consolidated financial statements, other operating income related to collaboration arrangements where the Company satisfies obligations during the development phase over time is typically recognized using an input method on the basis of research and development costs incurred relative to the total expected costs which determines the extent of progress towards completion of the obligation.
Other operating income for non-refundable up-front payments and development milestones for which management used an input method, was $42.5 million for the year ended December 31, 2021.
+Added: As of December 31, 2021, $ 322.5 million was included in other liabilities representing the amount of previously deferred non-refundable up-front and development milestones expected to be recognized in other operating income over time.
Management has disclosed that there is variability in the scope of activities and length of time necessary to develop a drug product, potential delays in development programs, changes to development plans and budgets as programs progress, and uncertainty in the ultimate requirements to obtain governmental approval for commercialization related to these estimates.
−Removed: The principal considerations for our determination that performing procedures relating to recognition of other operating income related to research and development up-front and milestone payments is a critical audit matter are the significant judgment by management when determining the estimate of total expected research and development costs to complete the obligation, which in turn led to significant audit effort in performing procedures and evaluating evidence to assess the reasonableness of the estimates of the costs to complete.
+Added: The principal considerations for our determination that performing procedures relating to the accounting for other operating income related to research and development up-front and milestone payments is a critical audit matter are the significant judgment by management when determining the estimate of total expected research and development costs to complete the obligation, which in turn led to a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating evidence to assess the reasonableness of the estimates of the costs to complete.
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 relating to the other operating income recognition process, including controls over the determination of the estimate of total expected research and development costs to complete the obligation.
+Added: These procedures included testing the effectiveness of controls relating to the accounting for other operating income related to research and development up-front and milestone payments, including controls over the determination of the estimate of total expected research and development costs to complete the obligation.
These procedures also included, among others, evaluating and testing management’s process for determining the estimate of total expected research and development costs at completion for a sample of contracts, which included evaluating the reasonableness of actual costs incurred and estimated costs to complete.
12 unchanged sentences
Marketable securities 2,809.1 1,393.3
−Removed: Accounts receivable - trade, net 3,111.5 2,100.0
−Removed: Accounts receivable - Sanofi, net 404.7 260.6
−Removed: Accounts receivable - other, net 598.5 425.0
+Added: Accounts receivable, net 6,036.5 4,114.7
Inventories 1,951.3 1,916.6
10 unchanged sentences
Accrued expenses and other current liabilities 2,206.8 1,644.2
−Removed: Deferred revenue - Sanofi 341.7 310.5
−Removed: Deferred revenue - other 236.0 71.6
−Removed: Other liabilities - Sanofi 122.4 85.0
+Added: Finance lease liabilities 719.7 —
+Added: Deferred revenue 442.0 577.7
Total current liabilities 3,932.5 2,697.4
1 unchanged sentence
Finance lease liabilities — 717.2
−Removed: Deferred revenue - Sanofi 16.7 27.7
−Removed: Deferred revenue - other 41.1 77.6
−Removed: Other liabilities - Sanofi 189.3 482.0
+Added: Deferred revenue 73.3 57.8
Other noncurrent liabilities 680.2 687.1
7 unchanged sentences
40,000,000 shares authorized;
−Removed: shares issued and outstanding - 1,848,970 in 2020 and 2019
+Added: shares issued and outstanding - 1,823,283 in 2021 and 1,848,970 in 2020
Common Stock, $ .001 par value;
3 unchanged sentences
Retained earnings 18,968.3 10,893.0
−Removed: Accumulated other comprehensive income 29.3 21.1
+Added: Accumulated other comprehensive (loss) income ( 26.2 ) 29.3
Treasury Stock, at cost;
12 unchanged sentences
Sanofi collaboration revenue 1,902.2 1,186.4 403.6
−Removed: Bayer collaboration revenue 1,186.1 1,145.6 1,036.1
+Added: Other collaboration revenue 1,771.1 1,186.1 1,145.6
Other revenue 281.2 557.0 174.0
21 unchanged sentences
Other comprehensive income (loss), net of tax:
−Removed: Unrealized gain (loss) on debt securities 9.1 35.9 ( 7.0 )
−Removed: Unrealized (loss) gain on cash flow hedges ( 0.9 ) ( 2.5 ) 0.7
+Added: Unrealized (loss) gain on debt securities ( 56.4 ) 9.1 35.9
+Added: Unrealized gain (loss) on cash flow hedges 0.9 ( 0.9 ) ( 2.5 )
Comprehensive income $ 8,019.8 $ 3,521.4 $ 2,149.2
9 unchanged sentences
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.5 ) — ( 188.0 ) — — — — ( 188.0 )
−Removed: Issuance of Common Stock for 401(k) Savings Plan — — 0.1 — 26.9 — — — — 26.9
+Added: Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 24.9 — — 0.1 13.2 38.1
Repurchases of Common Stock — — — — — — — ( 1.0 ) ( 356.7 ) ( 356.7 )
+Added: Conversion of Class A Stock to Common Stock ( 0.1 ) — 0.1 — — — — — — —
Stock-based compensation charges — — — — 466.9 — — — — 466.9
−Removed: Cumulative-effect adjustment upon adoption of new accounting standards — — — — — ( 136.8 ) ( 6.6 ) — — ( 143.4 )
+Added: Adjustment upon adoption of new accounting standard — — — — — 9.7 — — — 9.7
Net income — — — — — 2,115.8 — — — 2,115.8
−Removed: Other comprehensive loss, net of tax — — — — — — ( 6.3 ) — — ( 6.3 )
+Added: Other comprehensive income, net of tax — — — — — — 33.4 — — 33.4
Balance, December 31, 2019 1.8 — 113.3 0.1 4,428.6 7,379.8 21.1 ( 4.9 ) ( 739.9 ) 11,089.7
3 unchanged sentences
Repurchases of Common Stock — — — — — — — ( 11.6 ) ( 5,880.9 ) ( 5,880.9 )
−Removed: Conversion of Class A Stock to Common Stock ( 0.1 ) — 0.1 — — — — — — —
Stock-based compensation charges — — — — 442.9 — — — — 442.9
−Removed: Adjustment upon adoption of new accounting standard — — — — — 9.7 — — — 9.7
Net income — — — — — 3,513.2 — — — 3,513.2
10 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
10 unchanged sentences
Non-cash compensation expense 601.7 432.0 464.3
+Added: Gains on marketable and other securities, net ( 387.0 ) ( 221.8 ) ( 131.5 )
Other non-cash items, net 568.7 86.8 102.2
1 unchanged sentence
Changes in assets and liabilities:
−Removed: Increase in trade, Sanofi, and other accounts receivable ( 1,356.1 ) ( 523.7 ) ( 236.4 )
+Added: Increase in accounts receivable ( 1,927.4 ) ( 1,356.1 ) ( 523.7 )
Increase in inventories ( 494.3 ) ( 529.4 ) ( 335.5 )
−Removed: Decrease (increase) in prepaid expenses and other assets 114.9 ( 79.8 ) ( 88.1 )
−Removed: Increase (decrease) in deferred revenue 148.1 139.5 ( 43.4 )
+Added: (Increase) decrease in prepaid expenses and other assets ( 240.7 ) 114.9 ( 79.8 )
+Added: (Decrease) increase in deferred revenue ( 120.2 ) 148.1 139.5
Increase in accounts payable, accrued expenses, and other liabilities 866.1 118.9 599.0
5 unchanged sentences
Capital expenditures ( 551.9 ) ( 614.6 ) ( 429.6 )
−Removed: Other — — ( 10.0 )
Net cash used in investing activities ( 5,384.7 ) ( 70.6 ) ( 2,027.8 )
Cash flows from financing activities:
−Removed: Proceeds from issuance of long-term debt, net of issuance costs 1,981.9 — —
−Removed: Proceeds from bridge loan facility 1,500.0 — —
−Removed: Repayment of bridge loan facility ( 1,500.0 ) — —
Proceeds from issuance of Common Stock 1,672.3 2,575.2 211.8
2 unchanged sentences
Repurchases of Common Stock ( 1,645.4 ) ( 5,846.8 ) ( 275.9 )
+Added: Proceeds from issuance of long-term debt — 1,981.9 —
+Added: Proceeds from bridge loan facility — 1,500.0 —
+Added: Repayment of bridge loan facility — ( 1,500.0 ) —
Net cash used in financing activities ( 1,005.8 ) ( 1,970.5 ) ( 252.1 )
8 unchanged sentences
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Business Overview and Summary of Significant Accounting Policies
1 unchanged sentence
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 the treatment of serious diseases.
−Removed: Our commercialized medicines and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases, and rare diseases.
−Removed: The Company's products that have received marketing approval consist of EYLEA ® (aflibercept), Dupixent ® (dupilumab), Libtayo ® (cemiplimab), Praluent ® (alirocumab), Kevzara ® (sarilumab), Inmazeb ™ (atoltivimab, maftivimab, and odesivimab-ebgn), ARCALYST ® (rilonacept), and ZALTRAP ® (ziv-aflibercept) .
−Removed: In addition, REGEN-COV ™ (casirivimab and imdevimab) received Emergency Use Authorization from the U.S.
−Removed: Food and Drug Administration ("FDA") for the treatment of mild to moderate COVID-19 in certain patients at high risk for progressing to severe COVID-19 and/or hospitalization.
+Added: 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.
+Added: Our commercialized medicines and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases, and rare diseases.
+Added: We currently have nine products that have received marketing approval by the U.S.
+Added: Food and Drug Administration ("FDA").
+Added: In addition, REGEN-COV ® has not been approved by the FDA, but has been authorized under an Emergency Use Authorization ("EUA") (see Note 3 and Note 6 for additional information).
The Company is a party to collaboration agreements to develop and commercialize, as applicable, certain products and product candidates (see Note 3).
−Removed: The Company operates in one business segment, which includes all activities related to the discovery, development, and commercialization of medicines for the treatment of serious diseases.
+Added: The Company operates in one business segment, which includes all activities related to the discovery, development, and commercialization of medicines for serious diseases.
The Company's business is subject to certain risks including, but not limited to, uncertainties relating to conducting research activities, product development, obtaining regulatory approvals, competition, and obtaining and enforcing patents.
3 unchanged sentences
Certain reclassifications have been made to prior period amounts to conform with the current period's presentation.
−Removed: Effective January 1, 2020, we changed the presentation of cost reimbursements from collaborators who are not deemed to be our customers from collaboration revenue to a reduction of the corresponding operating expense ( i.e.
−Removed: , either Research and development or Selling, general, and administrative) incurred by us.
−Removed: We also changed the presentation of amounts recognized in connection with up-front and development milestone payments received from collaboration revenue to other operating income.
−Removed: We made these changes in presentation because we believe the new presentation is preferable, as it better reflects the nature of the Company’s costs incurred and revenues earned pursuant to arrangements with collaborators and enhances the comparability of our financial statements with industry peers.
−Removed: The change in presentation has been applied retrospectively.
−Removed: The tables below present the impact of the change on the Company’s previously-filed Consolidated Balance Sheet as of December 31, 2019, the Consolidated Statement of Operations for the years ended December 31, 2019, and 2018, and the Consolidated Statement of Cash Flows for the years ended December 31, 2019, and 2018.
−Removed: The Company’s previously-filed balance sheet has been updated to reflect the addition of the caption Other liabilities for the presentation of up-front and development milestones paid by collaborators that are deferred.
−Removed: There was no impact on the Company’s previously-filed Consolidated Statements of Stockholders’ Equity.
−Removed: December 31, 2019
−Removed: Balance Sheet Data:
−Removed: As Previously Reported Adjustments As Revised
−Removed: Accrued expenses and other current liabilities $ 1,086.8 $ 124.6 $ 1,211.4
−Removed: Deferred revenue - Sanofi (current) $ 395.5 $ ( 85.0 ) $ 310.5
−Removed: Deferred revenue - other (current) $ 196.2 $ ( 124.6 ) $ 71.6
−Removed: Other liabilities - Sanofi (current) — $ 85.0 $ 85.0
−Removed: Deferred revenue - Sanofi (noncurrent) $ 509.7 $ ( 482.0 ) $ 27.7
−Removed: Deferred revenue - other (noncurrent) $ 109.3 $ ( 31.7 ) $ 77.6
−Removed: Other liabilities - Sanofi (noncurrent) — $ 482.0 $ 482.0
−Removed: Other noncurrent liabilities $ 286.0 $ 31.7 $ 317.7
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: Year Ended December 31, 2019 Year Ended December 31, 2018
−Removed: Statement of Operations Data:
−Removed: As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised
−Removed: Sanofi collaboration revenue
−Removed: $ 1,426.8 $ ( 1,023.2 ) $ 403.6 $ 1,111.1 $ ( 1,236.8 ) $ ( 125.7 )
−Removed: Bayer collaboration revenue $ 1,188.8 $ ( 43.2 ) $ 1,145.6 $ 1,076.7 $ ( 40.6 ) $ 1,036.1
−Removed: Other revenue
−Removed: $ 413.4 $ ( 239.4 ) $ 174.0 $ 416.8 $ ( 287.8 ) $ 129.0
−Removed: Total revenues $ 7,863.4 $ ( 1,305.8 ) $ 6,557.6 $ 6,710.8 $ ( 1,565.2 ) $ 5,145.6
−Removed: Research and development
−Removed: $ 3,036.6 $ ( 586.6 ) $ 2,450.0 $ 2,186.1 $ ( 717.3 ) $ 1,468.8
−Removed: Selling, general, and administrative
−Removed: $ 1,834.8 $ ( 492.9 ) $ 1,341.9 $ 1,556.2 $ ( 429.0 ) $ 1,127.2
−Removed: Cost of collaboration and contract manufacturing (1)
−Removed: $ 419.9 $ ( 17.1 ) $ 402.8 $ 254.1 $ ( 16.6 ) $ 237.5
−Removed: Other operating (income) expense, net
−Removed: — $ ( 209.2 ) $ ( 209.2 ) — $ ( 402.3 ) $ ( 402.3 )
−Removed: Total operating expenses $ 5,653.6 $ ( 1,305.8 ) $ 4,347.8 $ 4,176.4 $ ( 1,565.2 ) $ 2,611.2
−Removed: (1) In addition to the reclassification of certain amounts in connection with the change in accounting presentation described above, the Company also reclassified certain immaterial reimbursements that were previously classified as collaboration revenue to Cost of collaboration and contract manufacturing.
−Removed: Year Ended December 31, 2019 Year Ended December 31, 2018
−Removed: Cash Flows Data:
−Removed: As Previously Reported Adjustments As Revised As Previously Reported Adjustments As Revised
−Removed: Cash flows from operating activities:
−Removed: Increase (decrease) in deferred revenue $ 294.0 $ ( 154.5 ) $ 139.5 $ ( 194.5 ) $ 151.1 $ ( 43.4 )
−Removed: Increase in accounts payable, accrued expenses, and other liabilities
−Removed: $ 444.5 $ 154.5 $ 599.0 $ 209.9 $ ( 151.1 ) $ 58.8
−Removed: We adopted Accounting Standards Codification ("ASC") 842, Leases , on January 1, 2019 (the "effective date") and used the effective date as our date of initial application.
−Removed: The new standard requires a lessee to recognize on its balance sheet (for both finance and operating leases) a liability for future lease payments and a right-of-use asset representing its right to use the underlying asset over the lease term.
−Removed: We elected the practical expedients upon transition, which permitted companies to not reassess lease identification, classification, and initial direct costs under the new standard for leases that commenced prior to the effective date.
−Removed: Upon adoption of the new standard, we recognized right-of-use assets of $ 33.2 million related to operating leases as of January 1, 2019.
−Removed: The impact of adopting the standard for the facilities that we had historically applied build-to-suit and capital lease accounting was not material to our Consolidated Financial Statements.
−Removed: Prior period amounts were not adjusted in connection with the adoption of this standard.
−Removed: We adopted ASC 606, Revenue from Contracts with Customers , as of January 1, 2018.
−Removed: The Company adopted the standard using the modified retrospective method, and thus recognized a cumulative-effect adjustment to reduce Retained earnings and increase Deferred revenue on January 1, 2018 by $ 143.4 million, net of tax.
Use of Estimates
2 unchanged sentences
The extent to which the COVID-19 pandemic may directly or indirectly impact our business, financial condition, and results of operations is highly uncertain and subject to change.
−Removed: We considered the potential impact of the COVID-19 pandemic on our estimates and assumptions and there was not a material impact to our consolidated
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: financial statements as of and for the year ended December 31, 2020;
+Added: We considered the potential impact of the COVID-19 pandemic on our estimates and assumptions and, other than the inventory write-offs and reserves recorded related to REGEN-COV (see Note 6), there was not a material impact to our consolidated financial statements as of and for the year ended December 31, 2021;
however, actual results could differ from those estimates and there may be changes to our estimates in future periods.
2 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 accounts receivable are significant.
−Removed: The Company has a concentration of credit risk associated with the receivables due from its collaborators Bayer, Sanofi, and Teva.
−Removed: The Company is also subject to credit risk with accounts receivable from its product sales to its customers.
−Removed: As of December 31, 2020 and 2019, three individual customers accounted for 93 % and 97 %, respectively, of the Company's net trade accounts receivable balances.
+Added: Concentrations of credit risk with respect to customer and collaborator accounts receivable are significant.
+Added: As of December 31, 2021, three individual customers accounted for 91 % (including 29 % related to the U.S.
+Added: government) of the Company's net trade accounts receivable balances.
+Added: Three individual customers accounted for 93 % of the Company's net trade accounts receivable balances as of December 31, 2020.
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.
5 unchanged sentences
Debt and Equity Securities
−Removed: The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and concentration and diversification.
−Removed: We invest our cash primarily in debt securities of investment grade institutions.
+Added: The Company has an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and diversification.
+Added: We invest our cash primarily in debt securities.
We consider our investments in debt securities to be "available-for-sale," as defined by authoritative guidance issued by the Financial Accounting Standards Board ("FASB").
13 unchanged sentences
The Company determines the cost of inventory using the first-in, first-out, or FIFO, method.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
The Company capitalizes inventory costs associated with the Company's products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized;
3 unchanged sentences
In addition, the Company's products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process.
−Removed: If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, the Company records a charge to write down such unmarketable inventory to its estimated realizable value.
+Added: If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, the Company records a charge to write down such inventory to its estimated realizable value.
Property, Plant, and Equipment
4 unchanged sentences
Expenditures for maintenance and repairs which do not materially extend the useful lives of the assets are charged to expense as incurred.
−Removed: The cost and accumulated depreciation or amortization of assets retired or sold are removed from the respective accounts, and any gain or loss is recognized in operations.
+Added: The cost and accumulated depreciation or amortization of assets retired or sold are removed from the respective accounts, and any gain or loss is recognized in income (loss) from operations.
The estimated useful lives of property, plant, and equipment are as follows:
6 unchanged sentences
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.
−Removed: The Company accounts for lease components ( e.g.
−Removed: , rental payments) separately from non-lease components ( e.g.
−Removed: , common area maintenance costs).
−Removed: Right-of-use assets and lease liabilities are recognized at lease commencement date based on the present value of lease payments over the lease term, unless there is a transfer of title or purchase option we are reasonably certain to exercise.
+Added: The Company accounts for lease components (e.g., rental payments) separately from non-lease components (e.g., common area maintenance costs).
+Added: Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term, unless there is a transfer of title or purchase option we are reasonably certain to exercise.
For leases where an implicit rate is not readily determinable, we use our incremental borrowing rate based on information available at the lease commencement date to determine the present value of future lease payments.
1 unchanged sentence
Revenue Recognition - Product Revenue
−Removed: Revenue from product sales is recognized at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt by our customer.
+Added: Revenue from product sales is recognized at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt or acceptance by our customer.
The amount of revenue we recognize from product sales may vary due to rebates, chargebacks, and discounts provided under governmental and other programs, distribution-related fees, and other sales-related deductions.
−Removed: In order to determine the transaction price, we estimate, utilizing the expected value method, the amount of variable consideration that we will be entitled to.
+Added: In order to determine the transaction price, we estimate, utilizing the expected value method, the amount of variable consideration to which we will be entitled.
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.
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.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: • Rebates, Chargebacks, and Discounts:
−Removed: The Company estimates reductions to product sales for Medicaid and Veterans' Administration ("VA") programs as well as certain other qualifying federal and state government programs, and other programs, including group purchasing organizations, and records an allowance for rebates and chargebacks.
−Removed: The Company's liability for Medicaid rebates consists of estimates for claims that a state will make for a current quarter, claims for prior quarters that have been estimated for which an invoice has not been received, and invoices received for claims from prior quarters that have not been paid.
−Removed: The Company's reserves related to discounted pricing to VA, Public Health Services, eligible physicians, and others (collectively "qualified healthcare providers") represent the Company's estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices the Company charges to its customers ( i.e.
−Removed: , distributors and specialty pharmacies).
−Removed: The Company's customers charge the Company for the difference between what they pay for the products and the ultimate selling price to the qualified healthcare providers.
−Removed: The Company's reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed.
+Added: The Company’s rebates include amounts paid to managed care organizations, group purchasing organizations, state Medicaid programs, and other rebate programs.
+Added: 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.
+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 inventory that exists in the distribution channel at the end of the period.
+Added: • Chargebacks and Discounts:
+Added: The Company's reserves related to discounted pricing to eligible physicians, Veterans' Administration ("VA"), Public Health Services, and others (collectively "qualified healthcare providers") represent the Company's estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices the Company charges to its customers (i.e., distributors and specialty pharmacies).
+Added: The Company's customers charge the Company for the difference between what they pay for the products and the discounted selling price to the qualified healthcare providers.
+Added: The Company estimates reductions to product sales for each type of chargeback and records an allowance for chargebacks in the same period that the related product sales are recognized.
+Added: The Company's reserve for chargebacks consists of amounts for which we expect to issue credit based on expected sales by our customers to qualified healthcare providers and chargebacks that customers have claimed but for which we have not yet issued credit.
• Distribution-Related Fees:
10 unchanged sentences
Collaborative Arrangements
−Removed: We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize product candidates and utilize our technology platforms.
+Added: We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize products and/or product candidates.
Although each of these arrangements is unique in nature, such arrangements involve a joint operating activity where both parties are active participants in the activities of the collaboration and exposed to significant risks and rewards dependent on the commercial success of the activities.
19 unchanged sentences
Other operating income
−Removed: In agreements involving multiple goods or services promised to be transferred to our collaborator, we must assess, at the inception of the contract, whether each promise represents a separate obligation ( i.e.
−Removed: , is "distinct"), or whether such promises should be combined as a single unit of account.
−Removed: When we have a combined unit of account which includes a license and providing research and development services to our collaborator, recognition of up-front payments and development milestones earned from our collaborator is deferred (as a liability) and recognized over the development period ( i.e.
−Removed: , over time).
+Added: In agreements involving multiple goods or services promised to be transferred to our collaborator, we must assess, at the inception of the contract, whether each promise represents a separate obligation (i.e., is "distinct"), or whether such promises should be combined as a single unit of account.
+Added: When we have a combined unit of account which includes a license and providing research and development services to our collaborator, recognition of up-front payments and development milestones earned from our collaborator is deferred (as a liability) and recognized over the development period (i.e., over time).
In arrangements where we satisfy our obligation(s) during the development phase over time, we recognize amounts initially deferred over time typically using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion.
We review our estimates each period and make revisions to such estimates as necessary.
−Removed: We recognized other operating income in connection with up-front and development milestones earned, for which we used an input method, of $ 276.7 million and $ 207.2 million for the years ended December 31, 2020 and 2019, respectively.
−Removed: When we are entitled to reimbursement of all or a portion of the expenses ( e.g.
−Removed: , research and development expenses) that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.
−Removed: If we and our collaborator perform development work or commercialization-related activities and share costs, we also recognize, as expense ( i.e.
−Removed: , research and development expense or selling, general, and administrative expense, as applicable) in the period when our collaborator incurs such expenses, the portion of the collaborator's expenses that we are obligated to reimburse.
+Added: We recognized other operating income in connection with non-refundable up-front and development milestones previously received, for which we used an input method, of $ 42.5 million and $ 276.7 million for the years ended December 31, 2021 and 2020, respectively.
+Added: As of December 31, 2021, $ 322.5 million was included in other liabilities representing the amount of previously deferred non-refundable up-front and development milestones expected to be recognized in other operating income over time.
+Added: When we are entitled to reimbursement of all or a portion of the expenses (e.g., research and development expenses) that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.
+Added: If our collaborator performs research and development work or commercialization-related activities and share costs, we also recognize, as expense (e.g., research and development expense or selling, general, and administrative expense, as applicable) in the period when our collaborator incurs such expenses, the portion of the collaborator's expenses that we are obligated to reimburse.
Our collaborators provide us with estimated expenses for the most recent fiscal quarter.
−Removed: Our collaborators' estimates are reconciled to their actual expenses for such quarter in the subsequent fiscal quarter, and our portion of our collaborators' expenses that we are obligated to reimburse is adjusted on a prospective basis accordingly, as necessary.
+Added: The estimates are revised, if necessary, in subsequent periods if actual expenses differ from those estimates.
Under certain of the Company's collaboration agreements, product sales and cost of sales may be recorded by the Company's collaborators as they are deemed to be the principal in the transaction.
In arrangements where we:
−Removed: • are obligated to use commercially reasonable efforts to supply commercial product to our collaborator, we may be reimbursed for our manufacturing costs as commercial product is shipped to the collaborator;
−Removed: however, recognition of such cost reimbursements is recognized when the product is sold by our collaborator to third-party customers;
+Added: • supply commercial product to our collaborator, we may be reimbursed for our manufacturing costs as commercial product is shipped to the collaborator;
+Added: however, recognition of such cost reimbursements may be deferred until the product is sold by our collaborator to third-party customers;
• share in any profits or losses arising from the commercialization of such products, we record our share of the variable consideration, representing net product sales less cost of goods sold and shared commercialization and other expenses, in the period in which such underlying sales occur and costs are incurred by the collaborator;
• receive royalties and/or sales-based milestone payments from our collaborator, we recognize such amounts in the period earned.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: Our collaborators provide us with estimates of product sales and our share of profits or losses, as applicable, for such quarter.
−Removed: These estimates are reconciled to actual results in the subsequent fiscal quarter, and collaboration revenue is adjusted accordingly, as necessary.
+Added: Our collaborators provide us with estimates of product sales and our share of profits or losses, as applicable, for each quarter.
+Added: The estimates are revised, if necessary, in subsequent periods if our actual share of profits or losses differ from those estimates.
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, the cost of services provided by outside contractors, including services related to the Company's clinical trials, clinical trial expenses, the full cost of manufacturing drug for use in research, preclinical development, and clinical trials, 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, such as rent, utilities, insurance, repairs and maintenance, depreciation, and general support services.
+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, 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.
Costs associated with research and development are expensed.
−Removed: For each clinical trial that we conduct, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter the trial, and/or the period over which clinical investigators, contract research organizations ("CROs"), or other third-party service providers are expected to provide services.
−Removed: In the event of early termination of a clinical trial, we accrue and recognize expenses in an amount based on our estimate of the remaining noncancelable obligations associated with the winding down of the clinical trial and/or penalties.
+Added: For each clinical trial that we conduct, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter and remain in the trial, and/or the period over which clinical investigators, contract research organizations ("CROs"), or other third-party service providers are expected to provide services.
+Added: In the event of early termination of a clinical trial, we accrue and recognize expenses in an amount based on our estimate of the remaining noncancelable obligations associated with the winding-down of the clinical trial, including any applicable penalties.
Stock-based Compensation
13 unchanged sentences
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.
−Removed: The Company adjusts the level of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions.
+Added: The Company adjusts the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions.
The Company recognizes interest and penalties related to income tax matters in income tax expense.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Per Share Data
5 unchanged sentences
(i) outstanding stock options and unvested restricted stock under the Company's long-term incentive plans, which are included under the treasury stock method when dilutive, and (ii) Common Stock that would be issued upon the achievement of certain market conditions, which are included under the treasury stock method when dilutive.
−Removed: Recently Adopted Accounting Standards
−Removed: We adopted Accounting Standards Update 2016-13, Financial Instruments - Credit Losses:
−Removed: Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"), as of January 1, 2020.
−Removed: ASU 2016-13 requires an entity to measure and recognize expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred.
−Removed: For available-for-sale debt securities with unrealized credit losses, the standard requires allowances to be recorded through net income instead of directly reducing the amortized cost of the investment under the previous other-than-temporary impairment model.
−Removed: The adoption of this standard did not have a material impact on our financial statements or a significant impact on our internal controls.
Product Sales
Net product sales consist of the following:
−Removed: Year Ended December 31,
+Added: (In millions) Year Ended December 31,
Net Product Sales in the United States 2021 2020 2019
−Removed: EYLEA $ 4,947.2 $ 4,644.2 $ 4,076.7
−Removed: Libtayo 270.7 175.7 14.8
−Removed: Praluent 150.9 * *
+Added: $ 5,792.3 $ 4,947.2 $ 4,644.2
+Added: 306.3 270.7 175.7
+Added: 170.0 150.9 * *
REGEN-COV ***
−Removed: ARCALYST 13.1 14.5 14.7
5,828.0 185.7 —
−Removed: * Effective April 1, 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States and records net product sales of Praluent in the United States.
+Added: 2.2 ** 13.1 14.5
+Added: $ 12,117.2 $ 5,567.6 $ 4,834.4
+Added: * 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.
+Added: Previously, Sanofi recorded net product sales of Praluent in the United States.
See Note 3 for further details.
+Added: ** Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States.
+Added: Previously, the Company recorded net product sales of ARCALYST in the United States.
+Added: *** Net product sales of REGEN-COV in the United States relate to product sold in connection with our agreements with the U.S.
+Added: See Note 3 for further details.
+Added: As of December 31, 2021 and 2020, the Company had $ 5.059 billion and $ 3.112 billion, respectively, of trade accounts receivable that were recorded within Accounts receivable, net.
The Company had product sales to certain customers that accounted for more than 10% of total gross product revenue for each of the years ended December 31, 2021, 2020, and 2019.
5 unchanged sentences
McKesson Corporation 18 % 32 % 33 %
+Added: government 43 % * —
+Added: * Sales to the U.S.
+Added: government represented less than 10% of total gross product revenue during the period
Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, and discounts, distribution-related fees, and other sales-related deductions.
1 unchanged sentence
Accruals for rebates, distribution-related fees, and other sales-related deductions are recorded within accrued liabilities.
−Removed: The following table summarizes the provisions, and credits/payments, for sales-related deductions for the years ended December 31, 2020, 2019, and 2018.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: Rebates, Chargebacks, and Discounts Distribution-
+Added: The following table summarizes the provisions, and credits/payments, for sales-related deductions.
+Added: (In millions) Rebates, Chargebacks,
+Added: and Discounts Distribution-
Related Fees Other Sales-
10 unchanged sentences
Balance as of December 31, 2021 $ 214.6 $ 80.0 $ 67.6 $ 362.2
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Collaboration, License, and Other Agreements
1 unchanged sentence
Statement of Operations Classification Year Ended December 31,
−Removed: 2020 2019 2018
−Removed: Regeneron's share of profits (losses) in connection with commercialization of antibodies Sanofi collaboration revenue
−Removed: $ 785.2 $ 209.3 $ ( 227.0 )
−Removed: Sales-based milestone earned Sanofi collaboration revenue $ 50.0 — —
−Removed: Reimbursement for manufacturing of commercial supplies
−Removed: Sanofi collaboration revenue
−Removed: $ 368.0 $ 216.0 $ 113.7
−Removed: Reimbursement of research and development expenses
−Removed: Reduction of Research and development expense
−Removed: $ 226.7 $ 277.7 $ 265.3
−Removed: Regeneron's obligation for its share of Sanofi research and development expenses
−Removed: Research and development expense
−Removed: $ ( 77.6 ) $ ( 46.0 ) $ ( 47.7 )
−Removed: Reimbursement of commercialization-related expenses
−Removed: Reduction of Selling, general, and administrative expense
−Removed: $ 359.4 $ 479.9 $ 417.2
−Removed: Regeneron's obligation for its share of Sanofi other expenses Cost of collaboration and contract manufacturing $ ( 21.5 ) $ ( 12.8 ) $ ( 16.1 )
+Added: (In millions) 2021 2020 2019
+Added: Regeneron's share of profits in connection with commercialization of antibodies Sanofi collaboration revenue $ 1,363.0 $ 785.2 $ 209.3
+Added: Sales-based milestones earned Sanofi collaboration revenue $ 50.0 $ 50.0 —
+Added: Reimbursement for manufacturing of commercial supplies Sanofi collaboration revenue $ 488.8 $ 368.0 $ 216.0
+Added: Reimbursement of research and development expenses Reduction of Research and development expense $ 175.9 $ 226.7 $ 277.7
+Added: Regeneron's obligation for its share of Sanofi research and development expenses Research and development expense $ ( 46.7 ) $ ( 77.6 ) $ ( 46.0 )
+Added: Reimbursement of commercialization-related expenses Reduction of Selling, general, and administrative expense $ 320.5 $ 359.4 $ 479.9
Immuno-oncology:
Regeneron's share of losses in connection with commercialization of Libtayo outside the United States Sanofi collaboration revenue $ ( 13.6 ) $ ( 25.7 ) $ ( 21.7 )
−Removed: Reimbursement for manufacturing of commercial supplies
−Removed: Sanofi collaboration revenue
−Removed: Reimbursement of research and development expenses
−Removed: Reduction of Research and development expense
−Removed: $ 166.2 $ 163.0 $ 311.8
−Removed: Reimbursement of commercialization-related expenses
−Removed: Reduction of Selling, general, and administrative expense
−Removed: $ 64.7 $ 10.3 $ 8.9
+Added: Reimbursement for manufacturing of commercial supplies Sanofi collaboration revenue $ 14.0 $ 8.9 —
+Added: Reimbursement of research and development expenses Reduction of Research and development expense $ 85.1 $ 166.2 $ 163.0
+Added: Reimbursement of commercialization-related expenses Reduction of Selling, general, and administrative expense $ 89.6 $ 64.7 $ 10.3
+Added: Regeneron's obligation for its share of Sanofi commercial expenses Selling, general, and administrative expense $ ( 36.3 ) $ ( 22.4 ) $ ( 15.4 )
Regeneron's obligation for Sanofi's share of Libtayo U.S.
gross profits Cost of goods sold $ ( 133.0 ) $ ( 119.1 ) $ ( 78.2 )
−Removed: Amounts recognized in connection with up-front payments received
−Removed: Other operating income
−Removed: $ 210.6 $ 92.7 $ 243.8
−Removed: See Note 9 and Note 11 for information regarding Sanofi's sale of our Common Stock during the second quarter of 2020.
+Added: Amounts recognized in connection with up-front payments received Other operating income $ 6.1 $ 210.6 $ 92.7
The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration"), which currently consists of Dupixent ® , Kevzara ® , and itepekimab .
2 unchanged sentences
However, we are only required to apply 10 % of our share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs.
−Removed: The Company's contingent reimbursement obligation to Sanofi under the Antibody Collaboration was approximately $ 3.103 billion as of December 31, 2020.
−Removed: Effective January 2018, the Company and Sanofi entered into a letter agreement (the "Letter Agreement") in connection with, among other matters, the allocation of additional funds to certain activities relating to dupilumab and itepekimab (collectively,
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: the "Dupilumab/Itepekimab Eligible Investments").
+Added: The Company's contingent reimbursement obligation (development balance) to Sanofi under the Antibody Collaboration was approximately $ 3.152 billion as of December 31, 2021.
+Added: Effective January 2018, the Company and Sanofi entered into a letter agreement (the "Letter Agreement") in connection with, among other matters, the allocation of additional funds to certain activities relating to dupilumab and itepekimab (collectively, the "Dupilumab/Itepekimab Eligible Investments").
Refer to the " Immuno-Oncology " section below for further details regarding the Letter Agreement and Note 11 for additional information regarding shares purchased by us from Sanofi.
−Removed: Regeneron is obligated to use commercially reasonable efforts to supply clinical requirements of each drug candidate under the Antibody Collaboration until commercial supplies of that drug candidate are being manufactured.
Sanofi leads commercialization activities for products under the Antibody Collaboration, subject to the Company's right to co-commercialize such products.
−Removed: The Company co-commercializes Dupixent in the United States and exercised its option to co-commercialize Dupixent in certain countries outside the United States.
−Removed: We currently anticipate commencing co-commercialization of Dupixent in such countries outside the United States in 2021.
+Added: The Company co-commercializes Dupixent in the United States and in certain countries outside the United States.
The parties equally share profits and losses from sales within the United States.
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, we are entitled to receive sales milestone payments from Sanofi.
−Removed: In the third quarter of 2020, the Company earned, and recognized as revenue, the first $ 50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of Dupixent, Kevzara, and Praluent outside the United States exceeding $ 1.0 billion on a rolling twelve-month basis.
−Removed: We are entitled to receive up to an aggregate of $ 200.0 million in additional milestone payments from Sanofi, including the second sales milestone in the amount of $ 50.0 million, when such sales outside the United States exceed $ 1.5 billion on a rolling twelve-month basis.
+Added: In addition to profit and loss sharing, the Company is entitled to receive sales milestone payments from Sanofi.
+Added: In each of 2020 and 2021, the Company earned, and recognized as revenue, a $ 50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $ 1.0 billion and $ 1.5 billion, respectively, on a rolling twelve-month basis.
+Added: We are entitled to receive up to an aggregate of $ 150.0 million in additional sales milestone payments from Sanofi, which includes the next sales milestone payment of $ 50.0 million that would be earned when such sales outside the United States exceed $ 2.0 billion on a rolling twelve-month basis.
In April 2020, the Company and Sanofi entered into an amendment to the LCA in connection with, among other things, the removal of Praluent from the LCA such that (i) effective April 1, 2020, the LCA no longer governs the development, manufacture, or commercialization of Praluent and (ii) the quarterly period ended March 31, 2020 was the last quarter for which Sanofi and the Company shared profits and losses for Praluent under the LCA.
−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, is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, is solely responsible for the development and commercialization of Praluent outside of the United States.
+Added: The parties also entered into a Praluent Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, became solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, became solely responsible for the development and commercialization of Praluent outside of the United States.
Under the Praluent Agreement, Sanofi will pay the Company a 5 % royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032.
6 unchanged sentences
We recognize amounts in connection with the Antibody Collaboration based on the amount we have the right to invoice and such amount corresponds directly with our performance to date;
−Removed: therefore, we do not disclose the value of the transaction price ( i.e.
−Removed: , the amount of consideration we expect to be entitled to) allocated to our remaining unsatisfied obligations.
+Added: therefore, we do not disclose the value of the transaction price (i.e., the amount of consideration we expect to be entitled to) allocated to our remaining unsatisfied obligations.
The following table summarizes contract balances in connection with the Company's Antibody Collaboration with Sanofi:
As of December 31,
−Removed: Accounts receivable
−Removed: $ 407.7 $ 272.7
+Added: (In millions) 2021 2020
+Added: Accounts receivable, net $ 504.8 $ 407.7
Deferred revenue
$ 368.7 $ 347.7
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Immuno-Oncology
2 unchanged sentences
In connection with the execution of the original Immuno-oncology Discovery and Development Agreement in 2015 ("2015 IO Discovery Agreement"), which has been replaced by the Amended IO Discovery Agreement (as discussed below), Sanofi made a $ 265.0 million non-refundable up-front payment to the Company.
−Removed: Pursuant to the 2015 IO Discovery Agreement, the Company was to spend up to $ 1.090 billion to identify and validate potential immuno-oncology targets and develop therapeutic antibodies against such targets through clinical proof-of-concept, and Sanofi was to reimburse the Company for up to $ 825.0 million of these costs, subject to certain annual limits.
−Removed: We are obligated to reimburse Sanofi for half of the development costs they funded that are attributable to clinical development of antibody product candidates from our share of future profits from commercialized IO Collaboration products.
+Added: Pursuant to the 2015 IO Discovery Agreement, the Company was to identify and validate potential immuno-oncology targets and develop therapeutic antibodies against such targets through clinical proof-of-concept.
+Added: We are obligated to reimburse Sanofi for half of the development costs it funded that are attributable to clinical development of antibody product candidates from our share of future profits from commercialized IO Collaboration products.
However, the Company is only required to apply 10 % of its share of the profits from IO Collaboration products in any calendar quarter towards reimbursing Sanofi for these development costs.
2 unchanged sentences
The Amended IO Discovery Agreement provided for Sanofi’s payment of $ 461.9 million to the Company as consideration for (x) the termination of the 2015 IO Discovery Agreement, (y) the prepayment for certain IO Development Activities regarding the BCMAxCD3 Program and the MUC16xCD3 Program, and (z) the reimbursement of costs incurred by the Company under the 2015 IO Discovery Agreement during the fourth quarter of 2018.
−Removed: Under the terms of the Amended IO Discovery Agreement, the Company is required to conduct development activities with respect to (i) the BCMAxCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $ 70.0 million (the "BCMAxCD3 Program Costs Cap") and (ii) the MUC16xCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $ 50.0 million (the "MUC16xCD3 Program Costs Cap").
−Removed: With regard to the BCMAxCD3 Program and the MUC16xCD3 Program, when (i) clinical proof-of-concept is established, (ii) the applicable Program Costs Cap is reached, or (iii) in certain other limited circumstances, Sanofi will have the option to license rights to the product candidate and other antibodies targeting the same targets for, with regard to BCMAxCD3, immuno-oncology indications, and with regard to MUC16xCD3, all indications, pursuant to the IO License and Collaboration Agreement, as amended.
−Removed: Given the applicable Program Costs Cap for the BCMAxCD3 Program and MUC16xCD3 Program has been reached, we expect Sanofi to provide its decision on whether it will exercise its option to license rights to these product candidates in early 2021.
−Removed: If Sanofi does not exercise its option to license rights to a product candidate, we will retain the exclusive right to develop and commercialize such product candidate and Sanofi will receive a royalty on sales.
−Removed: Pursuant to the Amended IO Discovery Agreement, the parties agreed that (i) if Sanofi exercises its option with respect to a BCMAxCD3 Program antibody, Sanofi will lead the development and global commercialization of such BCMAxCD3 Program antibody;
−Removed: and (ii) if Sanofi exercises its option with respect to a MUC16xCD3 Program antibody, (x) we will lead the development of such MUC16xCD3 Program antibody and commercialization of such MUC16xCD3 Program antibody within the United States and (y) Sanofi will lead the commercialization of such MUC16xCD3 Program antibody outside of the United States.
−Removed: If Sanofi exercises its option to license rights to a BCMAxCD3 Program antibody or MUC16xCD3 Program antibody thereunder, it will co-develop these drug candidates with the Company through product approval.
−Removed: Sanofi will fund development costs up front for a BCMAxCD3 Program antibody and we will reimburse half of the total development costs for such antibody from our share of future IO Collaboration profits to the extent they are sufficient for this purpose, subject to the same 10 % reimbursement provision described above.
−Removed: In addition, we and Sanofi will share equally, on an ongoing basis, the development costs for a MUC16xCD3 Program antibody.
+Added: Under the terms of the Amended IO Discovery Agreement, the Company was required to conduct development activities with respect to (i) the BCMAxCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $ 70.0 million and (ii) the MUC16xCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $ 50.0 million.
+Added: During the first quarter of 2021, Sanofi did not exercise its options to license rights to these product candidates;
+Added: as a result, we retain the exclusive right to develop and commercialize such product candidates and Sanofi will receive a royalty on sales (if any).
+Added: In addition, the Company has no further obligations to develop drug product candidates under the Amended IO Discovery Agreement.
In connection with the execution of the IO License and Collaboration Agreement in 2015, Sanofi made a $ 375.0 million non-refundable up-front payment to the Company.
−Removed: Under the terms of the IO License and Collaboration Agreement, the parties are co-developing and co-commercializing Libtayo (cemiplimab), an antibody targeting the receptor known as programmed cell death protein 1 (PD-1).
−Removed: The parties share equally, on an ongoing basis, agreed-upon development and commercialization
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: expenses for Libtayo.
−Removed: Pursuant to the Letter Agreement, the Libtayo development budget was increased and the Company allowed Sanofi to satisfy in whole or in part its funding obligations with respect to the Libtayo development and Dupilumab/Itepekimab Eligible Investments incurred in periods through September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi;
+Added: Under the terms of the IO License and Collaboration Agreement, the parties are co-developing and co-commercializing Libtayo (cemiplimab).
+Added: The parties share equally, on an ongoing basis, agreed-upon development and commercialization expenses for Libtayo.
+Added: Pursuant to the Letter Agreement, the Libtayo development budget was increased and the Company allowed Sanofi to satisfy in whole or in part its funding obligations with respect to the Libtayo development and Dupilumab/Itepekimab Eligible Investments incurred in periods through September 30, 2020 by selling certain shares of our Common Stock owned by Sanofi;
if Sanofi desired to sell such shares, we were able to elect to purchase, in whole or in part, such shares from Sanofi.
1 unchanged sentence
The Company has principal control over the development of Libtayo and leads commercialization activities in the United States (see Note 2 for related product sales information), while Sanofi leads commercialization activities outside of the United States.
−Removed: Sanofi has exercised its option to co-commercialize Libtayo in the United States.
−Removed: The Company will be entitled to a milestone payment of $ 375.0 million in the event that global sales of certain licensed products targeting PD-1 (including Libtayo), together with sales of any other products licensed under the IO License and Collaboration Agreement and sold for use in combination with any of such licensed products targeting PD-1, equal or exceed $ 2.0 billion in any consecutive twelve-month period.
−Removed: In August 2018, we and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E.
+Added: Sanofi co-commercializes Libtayo in the United States.
+Added: Each party has the right to co-commercialize licensed products in countries where it is not the lead commercialization party.
+Added: The parties share equally in profits and losses in connection with the commercialization of Libtayo.
+Added: In addition, the Company will be entitled to a milestone payment of $ 375.0 million in the event that global sales of Libtayo equal or exceed $ 2.0 billion in any consecutive twelve-month period.
+Added: In 2018, we and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E.
Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd.
to obtain a license under certain patents owned and/or exclusively licensed by one or more of those parties that includes the right to develop and sell Libtayo.
−Removed: Under the agreement, we and Sanofi made an up-front payment of $ 20.0 million and are obligated to pay royalties of 8.0 % on worldwide sales of Libtayo through December 31, 2023, and royalties of 2.5 % from January 1, 2024 through December 31, 2026.
+Added: Under the agreement, we and Sanofi made an up-front payment of $ 20.0 million and are obligated to pay royalties of 8.0 % on worldwide sales of Libtayo through December 31, 2023, and royalties
+Added: of 2.5 % from January 1, 2024 through December 31, 2026.
The up-front payment was shared, and the royalties are shared, equally by us and Sanofi.
−Removed: Each party will have the right to co-commercialize licensed products in countries where it is not the lead commercialization party.
−Removed: The parties share equally in profits and losses in connection with the commercialization of collaboration products.
−Removed: The Company is obligated to use commercially reasonable efforts to supply clinical requirements of each drug candidate under the IO License and Collaboration Agreement until commercial supplies of that IO drug candidate are being manufactured.
At the inception of the IO Collaboration, the Company's significant promised goods and services consisted of a license to certain rights and intellectual property and providing research and development services, including the manufacturing of clinical supplies.
2 unchanged sentences
Consequently, the $ 640.0 million in aggregate up-front payments made by Sanofi during 2015 in connection with the execution of the IO Collaboration was recorded within other liabilities and has been included in the transaction price.
−Removed: During 2020, we updated our estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the Sanofi IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $ 135.4 million to other operating income.
−Removed: During 2018, we updated our estimate of the total research and development costs expected to be incurred for this arrangement, including in connection with the termination of the 2015 IO Discovery Agreement, and, as result, a cumulative catch-up adjustment of $ 135.0 million was recorded to other operating income.
+Added: During 2021, we updated our estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $ 66.9 million as a reduction to other operating income.
+Added: During 2020, we updated our estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the Sanofi IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $ 135.4 million as an increase to other operating income.
The following table summarizes contract balances in connection with the Company's IO Collaboration with Sanofi:
As of December 31,
+Added: (In millions) 2021 2020
Accounts receivable, net
1 unchanged sentence
Deferred revenue
+Added: $ 16.0 $ 10.7
Other liabilities
$ 276.1 $ 280.9
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Other liabilities include up-front payments received from Sanofi for which recognition has been deferred.
1 unchanged sentence
This amount is expected to be recognized over the remaining period in which the Company is obligated to satisfy its obligation in connection with performing development activities.
−Removed: Amounts recognized in our Statements of Operations in connection with our Bayer EYLEA collaboration are as follows:
+Added: The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA and aflibercept 8 mg outside the United States.
+Added: All agreed-upon development expenses incurred by the Company and Bayer are shared equally.
+Added: The Company is also obligated to use commercially reasonable efforts to supply clinical and commercial bulk product.
+Added: Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from 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 thereafter, the companies share equally in profits and losses from sales.
+Added: Within the United States, the Company is responsible for commercialization and retains profits from such sales.
+Added: The Company is obligated to reimburse Bayer out of its share of the collaboration profits (including the Company's percentage of sales in Japan) for 50 % of the agreed upon development expenses that Bayer has incurred in accordance with a formula based on the amount of development expenses that Bayer has incurred and the Company's share of the collaboration profits, or at a faster rate at the Company's option.
+Added: The Company's contingent reimbursement obligation to Bayer was approximately $ 282 million as of December 31, 2021.
+Added: Amounts recognized in our Statements of Operations in connection with our Bayer collaboration are as follows:
Statement of Operations Classification Year Ended December 31,
−Removed: 2020 2019 2018
+Added: (In millions) 2021 2020 2019
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
−Removed: Bayer collaboration revenue
−Removed: $ 1,107.9 $ 1,091.4 $ 992.3
+Added: Other collaboration revenue $ 1,349.2 $ 1,107.9 $ 1,091.4
Reimbursement for manufacturing of commercial supplies
−Removed: Bayer collaboration revenue
−Removed: $ 78.2 $ 54.2 $ 43.8
+Added: Other collaboration revenue $ 60.1 $ 78.2 $ 54.2
Reimbursement of development expenses
4 unchanged sentences
$ ( 40.9 ) $ ( 35.8 ) $ ( 20.1 )
−Removed: Reimbursement of other expenses Cost of collaboration and contract manufacturing
−Removed: $ 7.4 $ 19.0 $ 28.9
−Removed: The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA outside the United States.
−Removed: All agreed-upon EYLEA development expenses incurred by the Company and Bayer are shared equally.
−Removed: The Company is also obligated to use commercially reasonable efforts to supply clinical and commercial bulk product of EYLEA.
−Removed: Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales of EYLEA.
−Removed: In Japan, the Company is currently entitled to receive a tiered percentage of between 33.5 % and 40.0 % of EYLEA net product sales through 2021, and thereafter, the companies will share equally in profits and losses from the sales of EYLEA.
−Removed: Within the United States, the Company is responsible for commercialization of EYLEA and retains exclusive rights to all profits from such commercialization in the United States.
−Removed: The Company is obligated to reimburse Bayer out of its share of the collaboration profits (including the Company's percentage of sales of EYLEA in Japan) for 50 % of the agreed-upon development expenses that Bayer has incurred in accordance with a formula based on the amount of development expenses that Bayer has incurred and the Company's share of the collaboration profits, or at a faster rate at the Company's option.
−Removed: The Company's contingent reimbursement obligation to Bayer was approximately $ 276 million as of December 31, 2020.
−Removed: The following table summarizes contract balances in connection with our Bayer EYLEA collaboration:
+Added: The following table summarizes contract balances in connection with our Bayer collaboration:
As of December 31,
−Removed: Accounts receivable - other
−Removed: $ 336.2 $ 311.6
+Added: (In millions) 2021 2020
+Added: Accounts receivable, net $ 355.5 $ 336.2
Deferred revenue
1 unchanged sentence
The Company and Teva are parties to a collaboration agreement (the "Teva Collaboration Agreement") to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with Mitsubishi Tanabe Pharma Corporation.
−Removed: In connection with the Teva Collaboration Agreement, Teva made a $ 250.0 million non-refundable up-front payment.
+Added: In connection with the agreement, Teva made a $ 250.0 million non-refundable up-front payment in 2016.
The Company leads global development activities, and the parties share development costs equally, on an ongoing basis, under a global development plan.
The Company is also responsible for the manufacture and supply of fasinumab globally.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Within the United States, the Company will lead commercialization activities, and the parties will share equally in any profits and losses in connection with commercialization of fasinumab.
In the territory outside the United States, Teva will lead commercialization activities and the Company will supply product to Teva at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances).
−Removed: During 2018, the Company achieved a development milestone of $ 60.0 million.
+Added: As of December 31, 2021, the Company had received an aggregate $ 120.0 million of development milestones from Teva.
The Company is entitled to receive up to an aggregate of $ 340.0 million in additional development milestones and up to an aggregate of $ 1.890 billion in contingent payments upon achievement of specified annual net sales amounts.
5 unchanged sentences
Statement of Operations Classification Year Ended December 31,
−Removed: 2020 2019 2018
+Added: (In millions) 2021 2020 2019
Reimbursement of research and development expenses
7 unchanged sentences
As of December 31,
−Removed: Accounts receivable - other $ 27.7 $ 21.2
+Added: (In millions) 2021 2020
+Added: Accounts receivable, net $ 11.0 $ 27.7
Other liabilities $ 39.7 $ 66.8
5 unchanged sentences
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
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: and limitations set forth in the agreement.
+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.
Certain targets that either we or Intellia select pursuant to the target selection process may be subject to a co-development and co-commercialization arrangement at our option or Intellia’s option, as applicable.
−Removed: In May 2020, we expanded our existing collaboration with Intellia to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the parties to jointly develop potential products for the treatment of hemophilia A and B.
+Added: In 2020, we expanded our existing collaboration with Intellia to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the parties to jointly develop potential products for the treatment of hemophilia A and B.
In addition, we also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products.
−Removed: In connection with the agreement, we made a $ 70.0 million up-front payment, which was recorded to Research and development expense in 2020, and purchased 925,218 shares of Intellia common stock for an aggregate purchase price of $ 30.0 million.
−Removed: The amount paid in excess of the fair market value of the shares purchased, or $ 15.0 million, was also recorded to Research and development expense in 2020.
−Removed: In the first quarter of 2020, we announced an expansion of our Other Transaction Agreement ("OTA") with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S.
+Added: In connection with the agreement, we made a $ 70.0 million up-front payment and purchased shares of Intellia common stock for an aggregate purchase price of $ 30.0 million.
+Added: The up-front payment and the amount paid in excess of the fair market value of the shares purchased, or $ 15.0 million, were recorded to Research and development expense during 2020.
+Added: REGEN-COV (casirivimab and imdevimab)
+Added: In the first quarter of 2020, we announced an expansion of our Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S.
Department of Health and Human Services ("HHS") was obligated to fund certain of our costs incurred for research and development activities related to COVID-19 treatments.
1 unchanged sentence
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, could result in 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: See Note 2 for REGEN-COV net product sales recognized in connection with this agreement during 2020.
+Added: The agreement, as subsequently amended, provided for payments to the Company of up to $ 465.9 million in the aggregate for bulk manufacturing of the drug substance, as well as fill/finish, storage, and other activities.
In January 2021, the Company announced an agreement with an entity acting on behalf of the U.S.
1 unchanged sentence
Pursuant to the agreement, the U.S.
−Removed: government is obligated to purchase all filled and finished doses of drug product delivered by June 30, 2021, and may accept doses during the period from July 1, 2021 through September 30, 2021 at its discretion.
−Removed: government will acquire doses at the lowest treatment dose authorized or approved by the FDA for the indication authorized under the EUA, resulting in payments to the Company of up to $ 2.625 billion in the aggregate.
−Removed: A number of factors may impact available filled and finished supply by June 30, 2021, including manufacturing considerations and authorized dose level.
−Removed: In August 2020, we entered into a collaboration agreement with Roche to develop, manufacture, and distribute REGEN-COV.
−Removed: We will continue to lead global development activities for REGEN-COV, and the parties will jointly fund certain ongoing studies, as well as any mutually agreed additional new global studies to evaluate further the potential of REGEN-COV in treating or preventing COVID-19.
−Removed: Roche will be responsible for securing regulatory approvals outside the United States, following the initial European Medicines Agency ("EMA") approval (if any), and conducting any additional studies specifically required for approval by regulators outside the United States.
−Removed: Under the terms of the agreement, each party is obligated to dedicate a certain amount of manufacturing capacity to REGEN-COV each year.
−Removed: We will distribute the product in the United States and Roche will distribute the product outside of the United States.
−Removed: The parties will 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: Any profit sharing will commence after product manufactured by Roche receives regulatory authorization.
−Removed: During 2020, we recorded $ 78.5 million of reimbursements received from Roche as a reduction of Research and development expense.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: In April 2019, the Company and Alnylam Pharmaceuticals, Inc.
+Added: government was obligated to purchase 1.25 million doses of drug product, which we delivered by June 30, 2021, resulting in payments to the Company of $ 2.625 billion.
+Added: In September 2021, the Company announced an amendment to its January 2021 agreement to supply the U.S.
+Added: government with an additional 1.4 million doses of REGEN-COV.
+Added: Pursuant to the agreement, the U.S.
+Added: 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.
+Added: Roche supplied a portion of the doses to Regeneron to fulfill our agreement with the U.S.
+Added: government (see "Roche" below for further details regarding our collaboration agreement with Roche).
+Added: As of December 31, 2021, the Company had completed its final deliveries of drug product under the agreements described above.
+Added: See Note 2 for REGEN-COV net product sales recognized in connection with these agreements.
+Added: In August 2020, we entered into a collaboration agreement (the "Roche Collaboration Agreement") with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve ™ in other countries).
+Added: We lead global development activities for casirivimab and imdevimab, and the parties jointly fund certain ongoing studies, as well as any mutually agreed additional new global studies to evaluate further the potential of casirivimab and imdevimab in treating or preventing COVID-19.
+Added: Under the terms of the agreement, each party is obligated to dedicate a certain amount of manufacturing capacity to casirivimab and imdevimab each year.
+Added: We distribute the product in the United States and Roche distributes the product outside of 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: Each quarter, a single payment is due from one party to the other to true-up the global gross profits between the parties.
+Added: If Regeneron is to receive a true-up payment from Roche, such amount will be recorded to Other collaboration revenue.
+Added: If Regeneron is to make a true-up payment to Roche, such amount will be recorded to Cost of goods sold.
+Added: Amounts recognized in our Statements of Operations in connection with the Roche Collaboration Agreement are as follows:
+Added: Statement of Operations Classification Year Ended December 31,
+Added: (In millions) 2021 2020
+Added: Global gross profit true-up payment from Roche in connection with sales of casirivimab and imdevimab Other collaboration revenue $ 361.8 —
+Added: Reimbursement of research and development expenses Reduction of Research and development expense $ 128.1 $ 78.5
+Added: Global gross profit true-up payment to Roche in connection with sales of casirivimab and imdevimab Cost of goods sold $ 259.6 —
+Added: The following table summarizes contract balances in connection with the Roche Collaboration Agreement:
+Added: As of December 31,
+Added: (In millions) 2021 2020
+Added: Accounts receivable, net — $ 77.1
+Added: Accrued expenses and other current liabilities $ 268.8 —
+Added: In 2019, the Company and Alnylam Pharmaceuticals, Inc.
entered into a global, strategic collaboration to discover, develop, and commercialize RNA interference ("RNAi") therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.
−Removed: The collaboration is governed by a Master Collaboration Agreement (the "Master Agreement") (including the form of a License Agreement and a Co-Commercialization Collaboration Agreement).
−Removed: Under the terms of the Master Agreement, we made an up-front payment of $ 400.0 million to Alnylam, which was recorded in Research and development expense during 2019.
−Removed: For each program, we will provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive up to an aggregate of $ 200.0 million in clinical proof-of-principle milestones for eye or CNS programs.
+Added: Under the terms of the agreement, we made an up-front payment of $ 400.0 million to Alnylam, which was recorded in Research and development expense during 2019.
+Added: For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive up to an aggregate of $ 200.0 million in clinical proof-of-principle milestones for eye and CNS programs.
Under the collaboration, the parties plan to perform discovery research until designation of lead candidates.
3 unchanged sentences
the actual amount of the fee will be determined based on the acceptance of one or more INDs (or their equivalent in certain other countries) for programs in the eye and CNS.
−Removed: In connection with the collaboration, we and Alnylam also entered into a Stock Purchase Agreement.
−Removed: Pursuant to the terms of the Stock Purchase Agreement, we purchased shares of Alnylam common stock for aggregate cash consideration of $ 400.0 million.
−Removed: In August 2019, the parties entered into a Co-Commercialization Collaboration Agreement for a silencing RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam, with Alnylam as the lead party, and a License Agreement for a combination product consisting of such siRNA therapeutic (cemdisiran) and a fully human monoclonal antibody targeting C5 being developed by us (pozelimab), with us as the licensee.
−Removed: The C5 siRNA Co-Commercialization Collaboration Agreement is consistent with the financial terms contained in the form of the existing Co-Commercialization Collaboration Agreement with Alnylam and the parties will share in development expenses equally.
−Removed: The C5 siRNA License Agreement contains a flat low double-digit royalty payable to Alnylam on our potential future net sales of the combination product only subject to customary reductions, as well as up to $ 325.0 million in commercial milestones.
+Added: In connection with the collaboration, we also purchased shares of Alnylam common stock for aggregate cash consideration of $ 400.0 million.
+Added: In addition, during 2019, the parties entered into a Co-Commercialization Collaboration Agreement for a silencing RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam, with Alnylam as the lead party, and a License Agreement for a combination product consisting of such siRNA therapeutic (cemdisiran) and a fully human monoclonal antibody targeting C5 being developed by us (pozelimab), with us as the licensee.
+Added: Under the C5 siRNA Co-Commercialization Collaboration Agreement, the parties share costs equally and will split profits (if commercialized);
+Added: and under the License Agreement, the licensee is responsible for its own costs and expenses.
+Added: The C5 siRNA License Agreement contains a flat low double-digit royalty payable to Alnylam on our potential future net sales of the combination product only subject to customary reductions, as well as up to $ 325.0 million in sales milestones.
In addition 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.
−Removed: Pursuant to the terms of those agreements, the Company may be required to pay, or it may receive, additional amounts upon the achievement of various development and commercial milestones which in the aggregate could be significant.
+Added: Pursuant to the terms of those agreements, the Company may be required to pay, or it may receive, additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of various development and commercial milestones) which in the aggregate could be significant.
The Company may also incur, or get reimbursed for, significant research and development costs if the related product candidate(s) were to advance to late stage clinical trials.
4 unchanged sentences
The following tables summarize the Company's investments in available-for-sale debt securities:
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: Amortized Unrealized Fair
+Added: (In millions) Amortized Unrealized Fair
As of December 31, 2021 Cost Basis Gains Losses Value
4 unchanged sentences
Certificates of deposit 255.2 — ( 0.1 ) 255.1
+Added: Asset-backed securities 42.0 — ( 0.1 ) 41.9
$ 8,428.7 $ 10.8 $ ( 42.3 ) $ 8,397.2
7 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, 2020 mature at various dates through October 2025.
−Removed: The fair values of available-for-sale debt security investments by contractual maturity consist of the following:
+Added: The available-for-sale debt securities listed as of December 31, 2021 mature at various dates through November 2026.
+Added: The fair values of available-for-sale debt securities by contractual maturity consist of the following:
As of December 31,
+Added: (In millions) 2021 2020
Maturities within one year $ 2,809.1 $ 1,393.3
1 unchanged sentence
$ 8,397.2 $ 3,689.1
−Removed: Unrealized losses of our available-for-sale debt securities that had been in a continuous loss position, for both less than and greater than 12 months, were not material for the years ended December 31, 2020 and 2019.
−Removed: Realized gains on sales of marketable securities for the year ended December 31, 2020 were $ 29.0 million and realized gains were no t material for the years ended December 31, 2019 and 2018.
−Removed: Realized losses on sales of marketable securities were no t material for the years ended December 31, 2020 and 2018 and there were no realized losses for the year ended December 31, 2019.
−Removed: With respect to marketable securities, for the years ended December 31, 2020, 2019, and 2018, 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 (as described above).
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
+Added: The following table shows the fair value of the Company's available-for-sale debt securities that have unrealized losses, aggregated by investment category and length of time that the individual securities have been in a continuous loss position.
+Added: Less than 12 Months 12 Months or Greater Total
+Added: (In millions)
+Added: As of December 31, 2021
+Added: Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss
+Added: Corporate bonds $ 5,889.3 $ ( 40.9 ) — — $ 5,889.3 $ ( 40.9 )
+Added: government and government agency obligations 90.0 ( 0.8 ) — — 90.0 ( 0.8 )
+Added: Sovereign bonds 37.0 ( 0.3 ) — — 37.0 ( 0.3 )
+Added: Commercial paper 295.7 ( 0.1 ) — — 295.7 ( 0.1 )
+Added: Certificates of deposit 169.4 ( 0.1 ) — — 169.4 ( 0.1 )
+Added: Asset-backed securities 34.9 ( 0.1 ) — — 34.9 ( 0.1 )
+Added: $ 6,516.3 $ ( 42.3 ) — — $ 6,516.3 $ ( 42.3 )
+Added: As of December 31, 2020
+Added: Corporate bonds $ 364.5 $ ( 0.2 ) — — $ 364.5 $ ( 0.2 )
+Added: Realized gains and losses on sales of marketable securities were no t material for the year ended December 31, 2021.
+Added: Realized gains on sales of marketable securities were $ 29.0 million and realized losses were no t material for the year ended December 31, 2020.
+Added: Realized gains on sales of marketable securities were no t material and there were no realized losses for the year ended December 31, 2019.
+Added: With respect to marketable securities, for the years ended December 31, 2021, 2020, and 2019, 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.
Fair Value Measurements
4 unchanged sentences
• Level 3 - Significant other unobservable inputs
−Removed: Fair Value Measurements at Reporting Date
+Added: (In millions) Fair Value Measurements at Reporting Date
As of December 31, 2021 Fair Value Level 1 Level 2
5 unchanged sentences
Certificates of deposit 255.1 — 255.1
+Added: Asset-backed securities 41.9 — 41.9
Equity securities (unrestricted) 58.4 $ 58.4 —
12 unchanged sentences
The Company held certain restricted equity securities as of December 31, 2021 which are subject to transfer restrictions that expire at various dates throug h 2024 .
−Removed: During the years ended December 31, 2020 and 2019, we recorded $ 196.0 million and $ 118.3 million of net unrealized gains, respectively, on equity securities in Other income (expense).
−Removed: During the year ended December 31, 2018, we recorded net unrealized losses on equity securities of $ 41.9 million in Other income (expense).
+Added: During the years ended December 31, 2021, 2020, and 2019, we recorded $ 386.1 million, $ 196.0 million, and $ 118.3 million of net unrealized gains, respectively, on equity securities in Other income (expense), net.
In addition to the investments summarized in the table above, as of December 31, 2021 and 2020, the Company had $ 40.0 million and $ 59.2 million, respectively, in equity investments that do not have a readily determinable fair value.
These investments are recorded within Other noncurrent assets.
−Removed: The fair value of our long-term debt (see Note 9) was estimated to be $ 1.958 billion as of December 31, 2020, and was determined based on Level 2 inputs.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
+Added: The fair value of our long-term debt (see Note 9), which was determined based on Level 2 inputs, was estimated to be $ 1.887 billion and $ 1.958 billion as of December 31, 2021 and 2020, respectively.
Inventories consist of the following:
As of December 31,
+Added: (In millions) 2021 2020
Raw materials $ 721.9 $ 459.4
3 unchanged sentences
$ 1,951.3 $ 1,916.6
+Added: Inventory balances in the table above are net of reserves of $ 510.0 million and $ 136.4 million as of December 31, 2021 and 2020, 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, 2020, 2019, and 2018, Cost of goods sold included inventory write-downs and reserves of $ 39.2 million, $ 73.8 million, and $ 12.5 million, respectively.
+Added: For the years ended December 31, 2021, 2020, and 2019, Cost of goods sold included inventory write-offs and reserves totaling $ 457.1 million, $ 39.2 million, and $ 73.8 million, respectively.
+Added: Included in the 2021 write-off and reserve amount was a fourth quarter charge of $ 231.7 million to write down our REGEN-COV inventory as a result of data that showed REGEN-COV was highly unlikely to be active against the Omicron variant and the FDA revision of the EUA for REGEN-COV, pursuant to which REGEN-COV was no longer authorized for use in any U.S.
+Added: states, territories, or jurisdictions.
Property, Plant, and Equipment
1 unchanged sentence
As of December 31,
+Added: (In millions) 2021 2020
Land $ 248.0 $ 241.2
10 unchanged sentences
Property, plant, and equipment in the table above includes leased property under the Company's finance lease at its Tarrytown, New York facility.
−Removed: Depreciation and amortization expense (including as it relates to the Company's finance lease) on property, plant, and equipment amounted to $ 230.8 million, $ 205.2 million, and $ 144.1 million for the years ended December 31, 2020, 2019, and 2018, respectively.
+Added: Depreciation and amortization expense on property, plant, and equipment was $ 281.1 million, $ 230.8 million, and $ 205.2 million for the years ended December 31, 2021, 2020, and 2019, respectively.
As of December 31, 2021 and 2020, $ 2.684 billion and $ 2.398 billion, respectively, of the Company's net property, plant, and equipment was located in the United States and $ 797.8 million and $ 823.8 million, respectively, was located in Europe (primarily in Ireland).
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Accrued Expenses and Other Current Liabilities
1 unchanged sentence
As of December 31,
+Added: (In millions) 2021 2020
Accrued payroll and related costs $ 440.7 $ 465.8
Accrued clinical expenses 295.8 283.0
−Removed: Accrued sales-related charges, deductions, and royalties
+Added: Accrued sales-related costs 472.7 423.9
Income taxes payable
+Added: Amounts due to collaborators (see Note 3) 287.4 16.1
Other accrued expenses and liabilities
11 unchanged sentences
Bridge Loan Facility
−Removed: As described in Note 11, in May 2020, we purchased shares of our Common Stock from Sanofi, in connection with Sanofi's secondary offering of our Common Stock held by Sanofi, with a combination of cash on hand, proceeds from the sale of marketable securities, and proceeds from loans under a $ 1.5 billion senior unsecured 364-day bridge loan facility (the "Bridge Facility").
+Added: As described in Note 11, in the second quarter of 2020, we purchased shares of our Common Stock from Sanofi in connection with Sanofi's secondary offering of our Common Stock held by Sanofi.
+Added: This purchase was partially funded with proceeds from loans under a $ 1.5 billion senior unsecured bridge loan facility (the "Bridge Facility") which was entered into in May 2020.
The loans under the Bridge Facility bore interest at a variable interest rate based on either the London Interbank Offered Rate or the alternate base rate, plus an applicable margin that varied with our debt rating and total leverage ratio.
−Removed: The Bridge Facility was repaid in full during 2020 following the closing of the issuance and sale of the Company's senior notes (as described below).
−Removed: In August 2020, we issued and sold $ 1.250 billion aggregate principal amount of senior unsecured notes due 2030 (the "2030 Notes") and $ 750 million aggregate principal amount of senior unsecured notes due 2050 (the "2050 Notes" and, together with the 2030 Notes, the "Notes").
−Removed: Net proceeds from the issuance and sale of the Notes (after deducting underwriting discounts and offering expenses) were used in part to repay in full the Bridge Facility described above, including accrued interest and related fees and expenses in connection therewith.
+Added: The Bridge Facility was repaid in full during the third quarter of 2020 following the closing of the issuance and sale of the Company's senior notes (as described below).
+Added: In August 2020, we issued and sold $ 1.250 billion aggregate principal amount of senior unsecured notes due 2030 and $ 750 million aggregate principal amount of senior unsecured notes due 2050 (collectively, the "Notes").
+Added: Net proceeds from the issuance and sale of the Notes (after deducting underwriting discounts and offering expenses) were used in part to repay in full the Bridge Facility described above.
The underwriting discounts and offering expenses are being amortized as additional interest expense over the period from issuance through maturity.
−Removed: The 2030 Notes accrue interest at the rate of 1.750 % per year and will mature on September 15, 2030.
−Removed: The 2050 Notes accrue interest at the rate of 2.800 % per year and will mature on September 15, 2050.
+Added: Long-term debt in connection with our senior unsecured notes, net of underwriting discounts and offering expenses, consists of the following:
+Added: December 31, December 31,
+Added: (In millions) 2021 2020
+Added: 1.750 % Senior Notes due September 2030
+Added: $ 1,239.9 $ 1,238.7
+Added: 2.800 % Senior Notes due September 2050
+Added: $ 1,980.0 $ 1,978.5
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 for the year ended December 31, 2020 was $ 17.6 million.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
+Added: Interest expense related to the Notes was $ 44.4 million and $ 17.6 million for the years ended December 31, 2021 and 2020, respectively.
The Notes may be redeemed at the Company’s option at any time at 100 % of the principal amount plus accrued and unpaid interest, and, until a specified period before maturity, a specified make-whole amount.
5 unchanged sentences
We also lease certain warehouses and vehicles.
−Removed: As described in Note 1, during the first quarter of 2019, we adopted ASC 842, Leases .
Operating leases
2 unchanged sentences
Finance leases
−Removed: In March 2017, we entered into a Participation Agreement with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital LLC ("BAL"), as lessor, and a syndicate of lenders (collectively, the "Lease Participants").
−Removed: In March 2017, we also entered into a Lease and Remedies Agreement with BAL, pursuant to which we have leased laboratory and office facilities in Tarrytown, New York (the "Facility") for a five-year term ending in March 2022.
−Removed: The Participation Agreement, the Lease and Remedies Agreement, and certain other related agreements were amended and restated in May 2019, among other things, to revise certain covenants, representations and warranties, and events of default to be substantially similar to those set forth in the agreement governing the Company's revolving credit facility (as so amended and restated, the "Participation Agreement" and the "Lease," respectively).
+Added: In March 2017, we entered into a Participation Agreement with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital LLC ("BAL"), as lessor, and a syndicate of lenders (collectively with BAL, the "Lease Participants"), which provided for $ 720.0 million of lease financing from the Lease Participants for the acquisition of laboratory and office facilities in Tarrytown, New York (the "Facility").
+Added: In March 2017, we also entered into a Lease and Remedies Agreement with BAL, pursuant to which we have leased the Facility from BAL for a five-year term ending in March 2022.
+Added: The Participation Agreement, the Lease and Remedies Agreement, and certain other related agreements were amended and restated in May 2019, among other things, to revise certain covenants, representations and warranties, and events of default to be substantially similar to those set forth in our Credit Facility (as so amended and restated, the "Participation Agreement" and the "Lease," respectively).
The Lease requires us to pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility.
3 unchanged sentences
The advances under the Participation Agreement mature, and all amounts outstanding thereunder will become due and payable in full, at the end of the term of the Lease.
−Removed: Prior to January 1, 2019, for certain of the premises under the Lease we were deemed, in substance, to be the owner of the buildings (collectively, the "Build-to-Suit Buildings").
−Removed: Upon the adoption of ASC 842, the classification of the Build-to-Suit Buildings, for which the construction period had been completed, was reassessed and, consequently, they were derecognized and recognized as a finance lease.
−Removed: These premises, along with the other premises under the Lease, are classified as a finance lease as we have the option to purchase the Facility under terms that make it reasonably certain to be exercised.
+Added: In September 2021, we delivered a request to the Lease Participants to potentially exercise the option for a five-year extension of the term of the Lease and the maturity date under the Participation Agreement.
+Added: In November 2021, the Lease Participants consented to such extension, subject to the satisfaction of certain conditions prior to the expiration of the existing term in March 2022, including the negotiation and execution of satisfactory definitive documentation setting forth the terms and conditions that would apply during such potential extended term.
+Added: We are negotiating such documentation with the Lease Participants, but there can be no assurance that such extension will become effective.
+Added: The Lease is classified as a finance lease as we have the option to purchase the Facility under terms that make it reasonably certain to be exercised.
The agreements governing the Lease financing contain financial and operating covenants.
The Company was in compliance with all such covenants as of December 31, 2021.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Amounts recognized in the Consolidated Balance Sheet related to the Lease are included in the table below.
1 unchanged sentence
As of December 31,
−Removed: Classification 2020 2019
+Added: (In millions) Classification 2021 2020
Finance lease right-of-use assets Property, plant, and equipment, net (1)
$ 631.3 $ 645.7
−Removed: Finance lease liabilities Finance lease liabilities (noncurrent)
−Removed: $ 717.2 $ 713.9
−Removed: (1) Finance lease right-of-use assets are recorded net of accumulated amortization of $ 90.5 million and $ 76.1 million as of December 31, 2020 and 2019, respectively.
+Added: Finance lease liabilities Finance lease liabilities $ 719.7 $ 717.2
+Added: (1) Finance lease right-of-use assets were recorded net of accumulated amortization of $ 104.9 million and $ 90.5 million as of December 31, 2021 and 2020, respectively.
Finance lease costs consist of the following:
Year Ended December 31,
+Added: (In millions) 2021 2020
Amortization of right-of-use assets $ 14.4 $ 14.4
7 unchanged sentences
The following is a maturity analysis of our finance lease liabilities:
−Removed: As of December 31, 2020
+Added: (In millions) As of December 31, 2021
Total undiscounted lease payments 723.0
2 unchanged sentences
Total lease liabilities $ 719.7
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Research Collaboration and Licensing Agreements
1 unchanged sentence
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 upon the achievement of various development and commercial milestones, contingent upon the occurrence of various future events.
+Added: Some of these agreements may require the Company to pay additional amounts contingent upon the occurrence of various future events (e.g., upon the achievement of various development and commercial milestones).
Additionally, we have in-licensed patent and/or technology pursuant to agreements which contain provisions that require the Company to pay royalties, as defined, at rates that range from 0.5 % to 10.0 %, in the event the Company sells or licenses any proprietary products developed under the respective agreements.
8 unchanged sentences
Under the Company's Restated Certificate of Incorporation, the Company's board of directors is authorized to issue up to 30 million shares of Preferred Stock, in series, with rights, privileges, and qualifications of each series determined by the board of directors.
−Removed: Share Repurchase Program
+Added: Share Repurchase Programs
In November 2019, our board of directors authorized a share repurchase program to repurchase up to $ 1.0 billion of our Common Stock.
−Removed: The share repurchase program permitted the Company to effect 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: The share repurchase program permitted the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.
As of December 31, 2020, the Company had repurchased the entire $ 1.0 billion it was authorized to repurchase under the program.
−Removed: The table below summarizes the shares of our Common Stock we repurchased under the program and the cost of the shares received, which were recorded as Treasury Stock.
+Added: In January 2021, our board of directors authorized a share repurchase program to repurchase up to $ 1.5 billion of our Common Stock.
+Added: The share repurchase program was approved under terms substantially similar to the November 2019 share repurchase program described above.
+Added: 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.
+Added: In November 2021, our board of directors authorized an additional share repurchase program to repurchase up to $ 3.0 billion of our Common Stock.
+Added: The share repurchase program was approved under terms substantially similar to the share repurchase programs above.
+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.
+Added: The program has no time limit and can be discontinued at any time.
+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, 2021, $ 2.845 billion remained available for share repurchases under the November 2021 program.
+Added: The table below summarizes the shares of our Common Stock we repurchased under the programs described above and the cost of the shares received, which were recorded as Treasury Stock.
Year Ended December 31,
+Added: (In millions) 2021 2020 2019
Number of shares repurchased 3.0 1.6 0.7
Total cost of shares received $ 1,655.0 $ 746.0 $ 254.0
−Removed: In January 2021, our board of directors authorized a new share repurchase program to repurchase up to $ 1.5 billion of our Common Stock.
−Removed: The share repurchase program was approved under terms substantially similar to the November 2019 share repurchase program described above.
−Removed: Arrangements with Sanofi
−Removed: In 2007, Sanofi purchased 12 million newly issued, unregistered shares of the Company's Common Stock.
−Removed: As a condition to the closing of this transaction, Sanofi entered into an investor agreement, as amended and restated, with the Company.
−Removed: Under the amended and restated investor agreement, Sanofi agreed not to dispose of any shares of the Company's Common Stock beneficially owned by Sanofi from time to time until December 20, 2020 (subject to the limited waiver described below).
−Removed: Further, pursuant to the amended and restated investor agreement, Sanofi is bound by certain "standstill" provisions, which contractually prohibit Sanofi from seeking to directly or indirectly exert control of the Company or acquiring more than 30 % of
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: the outstanding shares 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 later of the fifth anniversaries of the expiration or earlier termination of the Company's License and Collaboration Agreement with Sanofi and the Company's ZALTRAP Agreement with Sanofi, each as amended, and (ii) other specified events.
−Removed: Sanofi has also agreed to vote as recommended by the Company's board of directors, except that it may elect to vote proportionally with the votes cast by all of the Company's other shareholders with respect to certain change-of-control transactions, and to vote in its sole discretion with respect to liquidation or dissolution, stock issuances equal to or exceeding 20 % of the outstanding shares or voting rights of the Company's Class A Stock and Common Stock (taken together), and new equity compensation plans or amendments if not materially consistent with the Company's historical equity compensation practices.
−Removed: The rights and restrictions under the investor agreement are subject to termination upon the occurrence of certain events and have been amended in connection with the Secondary Offering and the Stock Purchase (each as defined below).
−Removed: As described in Note 3, effective January 2018, we and Sanofi entered into a Letter Agreement, which, among other things, amended certain provisions of the amended and restated investor agreement.
−Removed: Pursuant to the Letter Agreement, we granted Sanofi a limited waiver of the lock-up obligations under the investor agreement in order to allow Sanofi to satisfy in whole or in part its funding obligations with respect to Libtayo development costs and/or Dupilumab/Itepekimab Eligible Investments for quarterly periods ending on September 30, 2020 by selling our Common Stock directly or indirectly owned by Sanofi.
−Removed: The table below summarizes the shares of our Common Stock Sanofi elected to sell, and we elected to purchase, to satisfy Sanofi's funding obligations and the cost of the shares received, which were recorded as Treasury Stock.
−Removed: As of December 31,
−Removed: 2020 2019 2018
−Removed: Number of shares purchased (by issuing a credit towards the amount owed by Sanofi)
−Removed: 77,677 210,733 215,387
−Removed: Total cost of shares received $ 41.7 $ 73.3 $ 75.8
−Removed: Dupilumab/Itepekimab:
−Removed: Number of shares purchased (in cash) 171,471 93,286 10,766
−Removed: Total cost of shares received $ 93.3 $ 29.4 $ 4.4
+Added: Sanofi Funding of Certain Development Costs
+Added: As described in Note 3, in 2018, we and Sanofi entered into a Letter Agreement, which, among other things, granted Sanofi a limited waiver of Sanofi's lock-up obligations under the amended and restated investor agreement between us and Sanofi in order to allow Sanofi to satisfy its funding obligations with respect to Libtayo development costs and/or Dupilumab/Itepekimab Eligible Investments for quarterly periods ending on September 30, 2020 by selling our Common Stock owned by Sanofi.
+Added: During 2020 and 2019, Sanofi elected to sell, and we elected to purchase, shares of our Common Stock to satisfy Sanofi's funding obligation related to such activities.
+Added: Consequently, we recorded the cost of the shares received, or $ 135.0 million and $ 102.7 million, as Treasury Stock during 2020 and 2019, respectively.
+Added: Additional Stock Purchased from Sanofi
In May 2020, a secondary offering of 13,014,646 shares of our Common Stock (the "Secondary Offering") held by Sanofi was completed.
1 unchanged sentence
See Note 9 for additional information.
−Removed: As a result of the Secondary Offering and the Stock Purchase, Sanofi disposed of all of its shares of our Common Stock, other than 400,000 shares that it retained as of the closing of the Secondary Offering and the Stock Purchase (a portion of which Sanofi has 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 Share Purchase, (1) the “standstill” provisions, which contractually prohibit Sanofi from seeking to directly or indirectly exert control of the Company, continue to apply pursuant to their terms;
−Removed: (2) the voting commitments contained in the investor agreement continue to apply to the shares of Common Stock held by Sanofi and its affiliates following the secondary offering and stock repurchase, for so long as such shares are held by them;
−Removed: and (3) the lock-up restrictions in the investor agreement continued to apply to the shares of Common Stock held by Sanofi following the Secondary Offering and Stock Purchase until December 20, 2020 (except those shares which could be used to satisfy certain funding obligations of Sanofi).
+Added: As a result of the Secondary Offering and the Stock Purchase, Sanofi disposed of all of its shares of our Common Stock, other than 400,000 shares that it retained as of the closing of the Secondary Offering and the Stock Purchase (a portion of which Sanofi used for the funding of certain development costs described above).
+Added: In May 2020, the Company entered into an amendment to the amended and restated investor agreement, which provides, among other things, that following the Secondary Offering and Share Purchase, (1) the “standstill” provisions, which contractually prohibit Sanofi from seeking to directly or indirectly exert control of the Company, continue to apply pursuant to their terms and (2) the voting commitments contained in the investor agreement continue to apply to the shares of Common Stock held by Sanofi and its affiliates following the secondary offering and stock repurchase, for so long as such shares are held by them.
Arrangements with Other Collaborators
In connection with the Company's license and collaboration agreements with Bayer for the joint development and commercialization outside the United States of antibody product candidates to PDGFR-beta and Ang2, Bayer is bound by certain "standstill" provisions, which contractually prohibit Bayer from seeking to influence the control of the Company or acquiring more than 20 % of the Company's outstanding shares of Class A Stock and Common Stock (taken together).
−Removed: With respect to each of these agreements, this prohibition will remain in place until the earliest of (i) the fifth anniversary of the
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: termination of the agreement (which, in the case of the PDGFR-beta license and collaboration agreement, occurred on July 31, 2017, and, in the case of the Ang2 agreement, occurred on November 1, 2018) or (ii) other specified events.
+Added: With respect to each of these agreements, this prohibition will remain in place until the earliest of (i) the fifth anniversary of the termination of the agreement (which, in the case of the PDGFR-beta license and collaboration agreement, will occur on July 31, 2022, and, in the case of the Ang2 agreement, will occur on November 1, 2023) or (ii) other specified events.
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).
1 unchanged sentence
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 nonemployees, including nonemployee 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-employees, including 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").
1 unchanged sentence
2014 Long-Term Incentive Plan (the "Second Amended and Restated 2014 Incentive Plan").
−Removed: It was most recently adopted and approved by the Company's shareholders in 2020, at which time the Company registered an additional 12,000,000 shares of Common Stock for issuance thereunder.
−Removed: As of the most recent shareholder approval date, the Second Amended and Restated 2014 Incentive Plan provided for the issuance of up to 22,269,970 shares of Common Stock in respect of awards.
+Added: It was most recently adopted and approved by the Company's shareholders in 2020.
+Added: As of the most recent shareholder approval date, the Second Amended and Restated 2014 Incentive Plan provided for the issuance of up to 22.3 million shares of Common Stock in respect of awards.
In addition, upon expiration, forfeiture, surrender, exchange, cancellation, or termination of any award previously granted under the Amended and Restated Regeneron Pharmaceuticals, Inc.
2 unchanged sentences
The awards that may be made under the Second Amended and Restated 2014 Incentive Plan include:
−Removed: (a) incentive stock options and nonqualified stock options, (b) shares of restricted stock, (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) 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.
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 pro rata basis over a three - to 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.
2 unchanged sentences
Such shares are nontransferable for a period determined by the Committee ("vesting period").
−Removed: Should employment terminate, as specified in the Incentive Plans, except as determined by the Committee in its discretion and subject to the applicable Incentive Plan documents, the ownership of any unvested restricted stock will be transferred to the Company.
+Added: Should employment terminate, as specified in the Incentive Plans, except as determined by the Committee in its discretion and subject to the applicable Incentive Plan documents, the ownership of any unvested restricted stock awards will be transferred to the Company.
Phantom stock awards provide the Participant the right to receive Common Stock or an amount of cash based on the value of the Common Stock at a future date.
2 unchanged sentences
The Incentive Plans contain provisions that allow for the Committee to provide for the immediate vesting of awards upon a change in control of the Company, as defined in the Incentive Plans.
−Removed: As of December 31, 2020, there were 18,916,095 shares available for future grants under the Second Amended and Restated 2014 Incentive Plan.
+Added: As of December 31, 2021, there were 17.9 million shares available for future grants under the Second Amended and Restated 2014 Incentive Plan.
No additional awards may be made under the 2000 Incentive Plan, the Original 2014 Incentive Plan, or the Amended and Restated 2014 Incentive Plan.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Stock Options
Transactions involving stock option awards during 2021 under the Company's Incentive Plans are summarized in the table below.
−Removed: Number of Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (in years) Intrinsic Value
+Added: Number of Shares
+Added: (In millions)
+Added: Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term
+Added: Intrinsic Value
+Added: (In millions)
Outstanding as of December 31, 2020 21.7 $ 379.51
1 unchanged sentence
Forfeited ( 0.4 ) $ 419.51
−Removed: Expired ( 56,282 ) $ 473.77
Exercised ( 5.6 ) $ 299.23
3 unchanged sentences
The Company satisfies stock option exercises with newly issued shares of the Company's Common Stock.
−Removed: The total intrinsic value of stock options exercised during 2020, 2019, and 2018 was $ 2.251 billion, $ 558.9 million, and $ 510.6 million, respectively.
+Added: The total intrinsic value of stock options exercised during 2021, 2020, and 2019 was $ 1.707 billion, $ 2.251 billion, and $ 558.9 million, respectively.
The intrinsic value represents the amount by which the market price of the underlying stock exceeds the exercise price of an option.
The table below summarizes the weighted-average exercise prices and weighted-average grant-date fair values of options issued during the years ended December 31, 2021, 2020, and 2019.
−Removed: Number of Options Granted Weighted-Average Exercise Price Weighted-Average Fair Value
+Added: Number of Options Granted
+Added: (In millions)
+Added: Weighted-Average Exercise Price Weighted-Average Fair Value
Exercise price equal to Market Price 2.3 $ 628.43 $ 174.20
1 unchanged sentence
Exercise price equal to Market Price 3.3 $ 366.65 $ 100.80
−Removed: For the years ended December 31, 2020, 2019, and 2018, the Company recognized $ 329.5 million, $ 422.8 million, and $ 421.8 million, respectively, of non-cash stock-based compensation expense related to stock option awards (net of amounts capitalized as inventory of $ 8.3 million, $ 2.4 million, and $ 17.1 million, respectively).
−Removed: As of December 31, 2020, there was $ 491.5 million of stock-based compensation cost related to outstanding stock options, net of estimated forfeitures, which had not yet been recognized.
+Added: For the years ended December 31, 2021, 2020, and 2019, the Company recognized $ 328.7 million, $ 329.5 million, and $ 422.8 million, respectively, of non-cash stock-based compensation expense related to stock option awards (net of amounts capitalized as inventory, which were not material for each of the three years).
+Added: As of December 31, 2021, there was $ 515.9 million of stock-based compensation cost related to unvested stock options, net of estimated forfeitures, which had not yet been recognized.
The Company expects to recognize this compensation cost over a weighted-average period of 1.8 years.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Fair Value Assumptions:
12 unchanged sentences
A summary of the Company's activity related to restricted stock awards and time-based restricted stock units (excluding performance-based restricted stock units, which are detailed further below) (collectively, "restricted stock") during 2021 is summarized below.
−Removed: Number of Shares/Units Weighted-Average Grant
+Added: Number of Shares/Units
+Added: (In millions)
+Added: Weighted-Average Grant
Date Fair Value
2 unchanged sentences
Vested ( 0.2 ) $ 374.17
−Removed: Forfeited/Cancelled ( 46,061 ) $ 377.85
+Added: Forfeited ( 0.1 ) $ 440.08
Balance as of December 31, 2021 2.1 $ 499.85
The Company recognized non-cash stock-based compensation expense related to restricted stock of $ 221.0 million, $ 102.5 million, and $ 29.7 million in 2021, 2020, and 2019, respectively (net of amounts capitalized as inventory, which were not material for each of the three years).
−Removed: As of December 31, 2020, there was $ 425.5 million of stock-based compensation cost related to unvested restricted stock which had not yet been recognized.
+Added: As of December 31, 2021, there was $ 649.1 million of stock-based compensation cost related to
+Added: unvested restricted stock which had not yet been recognized.
The Company expects to recognize this compensation cost over a weighted-average period of 2.4 years.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Performance-based Restricted Stock Units
1 unchanged sentence
The PSUs will be earned based upon the achievement of predetermined, cumulative total shareholder return goals with respect to the Company's Common Stock price over a specified (generally five-year ) period beginning on the grant date.
−Removed: The number of PSUs granted shown in the table below represents the maximum number of units that are eligible to be earned.
+Added: The number of PSUs granted represents the maximum number of units that are eligible to be earned.
Depending on the terms of the PSUs and the outcome of the performance goals, a recipient may ultimately earn 0 % to 250 % (as specified for each PSU grant) of the target number of PSUs granted.
−Removed: A summary of the Company's activity related to PSUs during 2020 is summarized below.
−Removed: Number of Shares/Units Weighted-Average Grant
−Removed: Date Fair Value
−Removed: Balance as of December 31, 2019 59,396 $ 198.10
−Removed: Granted 1,240,540 $ 209.59
−Removed: Forfeited/Cancelled — —
−Removed: Balance as of December 31, 2020 1,299,936 $ 209.06
−Removed: The Company did no t recognize non-cash stock-based compensation expense related to PSUs in 2020 (as PSUs granted in 2020 were granted on December 31, 2020 and will be expensed over the vesting period).
−Removed: The Company recognized non-cash stock-based compensation expense related to PSUs of $ 11.7 million in 2019 (net of amounts capitalized as inventory, which were not material).
−Removed: PSUs were not granted during 2018.
+Added: As of December 31, 2021 and 2020, 1.3 million PSUs were outstanding with a weighted-average grant date fair value of $ 209.06 per unit.
+Added: During the year ended December 31, 2021, the Company did no t grant new PSUs and no PSUs were vested, forfeited, or cancelled.
+Added: The Company recognized non-cash stock-based compensation expense related to PSUs of $ 52.0 million and $ 11.7 million in 2021 and 2019, respectively.
+Added: The Company did no t recognize non-cash stock-based compensation expense related to PSUs in 2020 (as PSUs granted in 2020 were granted on December 31, 2020 and are expensed over the vesting period).
As of December 31, 2021, there was $ 208.0 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 during 2020 and 2019.
+Added: The following table summarizes the weighted average values of the assumptions used in computing the fair value of PSUs that were granted during 2020 and 2019.
Expected volatility 35 % 33 %
6 unchanged sentences
employees (as defined by the Savings Plan) to contribute to the Savings Plan a percentage of their compensation.
−Removed: In addition, the Company may make discretionary contributions ("Contribution"), as defined, to the accounts of participants under the Savings Plan.
−Removed: The Company recognized $ 44.7 million, $ 38.1 million, and $ 27.0 million of Contribution expense in 2020, 2019, and 2018, respectively.
+Added: In addition, the Company may make discretionary contributions, as defined, to the accounts of participants under the Savings Plan.
The Company also maintains additional employee savings plans outside of the United States, which cover eligible employees.
Expenses recognized by the Company related to contributions to such plans were not material during 2021, 2020, and 2019.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
The Company is subject to U.S.
2 unchanged sentences
Year Ended December 31,
−Removed: 2020 2019 2018
+Added: (In millions) 2021 2020 2019
United States $ 5,944.7 $ 2,442.3 $ 2,011.2
3 unchanged sentences
Year Ended December 31,
−Removed: 2020 2019 2018
+Added: (In millions) 2021 2020 2019
Federal $ 1,429.8 $ 199.0 $ 444.6
12 unchanged sentences
federal statutory tax rate 21.0 % 21.0 % 21.0 %
−Removed: Stock-based compensation ( 7.6 ) ( 2.5 ) ( 2.5 )
−Removed: Income tax credits ( 2.8 ) ( 4.6 ) ( 2.6 )
Taxation of non-U.S.
operations ( 2.8 ) ( 1.8 ) ( 1.0 )
−Removed: Sale of non-inventory related assets between foreign subsidiaries ( 0.8 ) — ( 6.3 )
+Added: Stock-based compensation ( 2.4 ) ( 7.6 ) ( 2.5 )
Foreign-derived intangible income deduction ( 1.4 ) — ( 1.6 )
−Removed: Non-deductible Branded Prescription Drug Fee 0.5 0.7 0.6
−Removed: Impact of change in U.S.
−Removed: corporate tax rate (the Act) — — ( 2.7 )
+Added: Income tax credits ( 1.0 ) ( 2.8 ) ( 4.6 )
+Added: Sale of non-inventory related assets between foreign subsidiaries — ( 0.8 ) —
Other permanent differences — ( 0.2 ) 1.6
Effective income tax rate 13.4 % 7.8 % 12.9 %
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: In December 2017, the bill known as the "Tax Cuts and Jobs Act" (the "Act") was signed into law.
−Removed: The Act, which became effective with respect to most of its provisions as of January 1, 2018, significantly revised U.S.
−Removed: corporate income tax laws by, among other things, reducing the U.S.
−Removed: federal corporate income tax rate from 35% to 21%.
−Removed: As a result of the Act being signed into law, the Company recognized a provisional charge in the fourth quarter of 2017 related to the re-measurement of its U.S.
−Removed: net deferred tax assets at the lower enacted corporate tax rate, and, during 2018, we recorded an income tax benefit of $ 68.0 million as a final adjustment to the provisional amount recorded as of December 31, 2017, which was partly attributable to our election to record deferred tax assets and liabilities for expected amounts of GILTI inclusions.
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
1 unchanged sentence
As of December 31,
+Added: (In millions) 2021 2020
Deferred tax assets:
Deferred compensation $ 406.6 $ 436.6
−Removed: Fixed assets and intangible assets 140.5 192.0
Accrued expenses 262.1 139.8
+Added: Fixed assets and intangible assets 257.5 140.5
Deferred revenue 57.3 44.6
+Added: Other 16.9 14.9
Total deferred tax assets 1,000.4 776.4
−Removed: Valuation allowance — ( 7.0 )
−Removed: Deferred tax assets, net of valuation allowance 761.5 802.6
Deferred tax liabilities:
−Removed: Other ( 42.8 ) ( 11.2 )
+Added: Unrealized gains on investments ( 123.5 ) ( 57.7 )
Net deferred tax assets $ 876.9 $ 718.7
2 unchanged sentences
In general, the Company's state income tax returns from 2016 to 2020 remain open to examination.
−Removed: The Company’s Commonwealth of Pennsylvania returns for 2015 through 2019 are currently under audit by the Commonwealth.
−Removed: The United States and many states generally have statutes of limitation ranging from 3 to 5 years;
+Added: The Company's income tax returns outside of the United States remain open to examination from 2018 to 2020.
+Added: T he United States and many states generally have statutes of limitation ranging from 3 to 5 years;
however, those statutes could be extended due to the Company's tax credit carryforward position.
2 unchanged sentences
The amount of unrecognized tax benefits that, if settled, would impact the effective tax rate is $ 410.9 million, $ 267.0 million, and $ 210.8 million as of December 31, 2021, 2020, and 2019, respectively.
−Removed: 2020 2019 2018
+Added: (In millions) 2021 2020 2019
Balance as of January 1 $ 267.0 $ 210.8 $ 189.5
4 unchanged sentences
Balance as of December 31 $ 410.9 $ 267.0 $ 210.8
+Added: During 2021, the decreases in unrecognized tax benefits related to the Company's federal income tax returns for 2015 and 2016, as these audits are closed.
In 2021, 2020, and 2019, the increases in unrecognized tax benefits primarily related to the Company's calculation of certain tax credits and other items related to the Company's international operations.
During 2021, 2020, and 2019, interest expense related to unrecognized tax benefits recorded by the Company was not material.
−Removed: The Company believes it is reasonably possible that its unrecognized tax benefits as of December 31, 2020 may decrease within
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: the next twelve months, and, as a result, positively impact our effective tax rate, as a result of expected settlement of audits and statute of limitation lapses.
+Added: The Company does not believe that it is reasonably possible that the resolution of tax exposures within the next twelve months would have a material impact on its unrecognized tax benefits as of December 31, 2021.
Legal Matters
3 unchanged sentences
The Company recognizes accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated.
−Removed: As of December 31, 2020 and 2019, the Company had accruals for loss contingencies of $ 9.6 million and $ 100.0 million, respectively.
+Added: As of December 31, 2021 and 2020, the Company's accruals for loss contingencies were not material.
If the Company were unable to prevail in any such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially impacted.
−Removed: Proceedings Relating to '287 Patent and '163 Patent
−Removed: The Company is a party to patent infringement litigation initiated by the Company involving its European Patent No.
−Removed: 1,360,287 (the "'287 Patent") and its European Patent No.
−Removed: 2,264,163 (the "'163 Patent").
−Removed: Each of these patents concerns genetically engineered mice capable of producing chimeric antibodies that are part human and part mouse.
−Removed: Chimeric antibody sequences can be used to produce high-affinity fully human monoclonal antibodies.
−Removed: In these proceedings, the Company claims infringement of several claims of the '287 Patent and the '163 Patent (as applicable), and seeks, among other types of relief, an injunction and an account of profits in connection with the defendants' infringing acts, which may include, among other things, the making, use, keeping, sale, or offer for sale of genetically engineered mice (or certain cells from which they are derived) that infringe one or more claims of the '287 Patent and the '163 Patent (as applicable).
−Removed: On September 25, 2013, the Company commenced patent infringement litigation against Kymab Ltd in the English High Court of Justice, Chancery Division, Patents Court, in London, asserting the '287 Patent and '163 Patent.
−Removed: Following a trial to adjudicate the claims of infringement and counterclaims of invalidity of the '287 Patent and the '163 Patent, the court issued a final judgment on February 1, 2016, finding that the asserted claims of the '287 and '163 Patents are novel, not obvious, and infringed by Kymab's genetically engineered mice.
−Removed: However, the court invalidated the '287 and '163 Patents on the ground of insufficiency.
−Removed: On appeal, the Court of Appeal (Civil Division of England and Wales) reversed the English High Court's decision and held that the '287 Patent and '163 Patent are both valid and infringed by Kymab and subsequently issued a final order, which enjoined Kymab from infringing the '287 Patent and '163 Patent (subject to certain exceptions) and required Kymab to destroy or deliver to a third party all products and antibodies and cells engineered to produce antibodies which infringe the '287 Patent and '163 Patent (subject to certain exceptions).
−Removed: On June 24, 2020, the Supreme Court of the United Kingdom overturned the decision of the Court of Appeal on validity and held that the '287 and '163 Patents are each invalid on the ground of insufficiency.
Proceedings Relating to Praluent (alirocumab) Injection
4 unchanged sentences
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 seeks 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.
+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) (collectively, "Commercializing") Praluent.
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.
−Removed: As described in greater detail under "Second Jury Trial and Appeal" below, the parties to this litigation are currently awaiting a decision by the Federal Circuit (as defined below) on Amgen's appeal.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
+Added: As described in greater detail under "Second Jury Trial and Appeal" below, on February 11, 2021, the Federal Circuit (as defined below) affirmed the lower court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.
First Jury Trial and Appeal.
15 unchanged sentences
An oral hearing before the Federal Circuit was held on December 9, 2020.
+Added: On February 11, 2021, the Federal Circuit affirmed the District Court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.
+Added: On April 14, 2021, Amgen filed a petition for a rehearing en banc, which was denied on June 21, 2021.
+Added: On November 18, 2021, Amgen filed a petition for writ of certiorari with the United States Supreme Court.
Injunctive Relief Proceedings.
4 unchanged sentences
2,215,124 (the "'124 Patent"), which pertains to PCSK9 monoclonal antibodies, in the countries in Europe discussed below.
−Removed: As described in greater detail under "EPO Proceedings" below, in October 2020 the '124 Patent claims directed to compositions of matter and medical use were ruled invalid by the Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO").
−Removed: This decision, subject to any review by the EPO Enlarged Board of Appeal, has impacted or will impact each of the infringement proceedings based on the '124 Patent discussed below.
−Removed: EPO Proceedings.
−Removed: The '124 Patent was subject to opposition proceedings in the EPO seeking to invalidate certain of its claims, which were initiated by Sanofi on February 24, 2016 and, separately, by the Company, Sanofi, and several other opponents on November 24, 2016.
−Removed: On December 13, 2017, the Opposition Division of the EPO issued a preliminary, non-binding opinion (the "Preliminary Opinion") regarding the validity of the '124 Patent, indicating that it currently considers the claims of a new request filed by Amgen in response to the opposition to satisfy the requirements for patentability.
−Removed: An oral hearing on the oppositions against the '124 Patent was held on November 28–30, 2018, at which the Opposition Division upheld the validity of the '124 Patent's claims in amended form.
−Removed: The Company and Sanofi filed notices of appeal to the TBA on November 30, 2018.
−Removed: An oral hearing before the TBA was held on October 28–29, 2020, at which the TBA ruled that the '124 Patent claims directed to compositions of matter and medical use were invalid based on a lack of inventive step.
−Removed: United Kingdom.
−Removed: On July 25, 2016, Amgen filed a lawsuit against Regeneron, Sanofi-Aventis Groupe S.A., Sanofi-Synthelabo Limited, Aventis Pharma Limited, Sanofi Winthrop Industrie S.A., and Sanofi-Aventis Deutschland GmbH in the English High Court of Justice, Chancery Division, Patents Court, in London, seeking a declaration of infringement of the '124 Patent by Praluent.
−Removed: The lawsuit also seeks a permanent injunction, damages, an accounting of profits, and costs and interest.
−Removed: On February 8, 2017, the court temporarily stayed this litigation on terms mutually agreed by the parties.
−Removed: On October 22, 2020, the court lifted the stay upon application by the Company and the Sanofi defendants, and the case will proceed in due course.
−Removed: On July 25, 2016, Amgen filed a lawsuit for infringement of the '124 Patent against Regeneron, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A., and Sanofi-Aventis Deutschland GmbH in the Regional Court of Düsseldorf,
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: Germany (the "Düsseldorf Regional Court"), seeking a permanent injunction, an accounting of marketing activities, a recall of Praluent and its removal from distribution channels, and damages.
−Removed: On November 14, 2017, the Düsseldorf Regional Court issued a decision staying the infringement proceedings until a decision of the Opposition Division of the EPO concerning the pending opposition filed by the Company, Sanofi, and several other opponents against the '124 Patent (as discussed above).
−Removed: Following Amgen's request to reopen the proceedings in light of the issuance of the Preliminary Opinion, the Düsseldorf Regional Court held an oral hearing on September 11, 2018 and ruled on December 10, 2018 that the infringement proceedings would be reopened.
−Removed: On July 11, 2019, the Düsseldorf Regional Court found that Praluent infringes the '124 Patent and granted an injunction prohibiting the Company and Sanofi's manufacture, sale, and marketing of Praluent in Germany (the "July 11 Decision").
−Removed: Amgen subsequently enforced the injunction and, as a result, commercialization of Praluent in Germany was discontinued.
−Removed: On July 12, 2019, the Company and Sanofi appealed the July 11 Decision to the Higher Regional Court of Düsseldorf (the "Higher Regional Court").
−Removed: On August 5, 2019 and October 31, 2019, the Higher Regional Court denied the Company and Sanofi's requests for a stay of preliminary enforcement of the July 11 Decision pending the appeal on the merits.
−Removed: On November 3, 2020, Amgen filed a motion withdrawing this lawsuit without prejudice.
−Removed: An oral hearing on the merits of the appeal to the Higher Regional Court was held on November 5, 2020, at which the Higher Regional Court overturned the July 11 Decision.
−Removed: On September 26, 2016, Amgen filed a lawsuit for infringement of the '124 Patent in the Tribunal de grande instance in Paris, France against Regeneron, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A., and Sanofi Chimie (subsequently added as a defendant).
−Removed: Amgen is seeking the prohibition of allegedly infringing activities with a € 10,000 penalty per drug unit of Praluent produced in violation of the court order sought by Amgen;
−Removed: an appointment of an expert for the assessment of damages;
−Removed: disclosure of technical (including supply-chain) and accounting information to the expert and the court;
−Removed: provisional damages of € 10.0 million (which would be awarded on an interim basis pending final determination);
−Removed: reimbursement of costs;
−Removed: publication of the ruling in three newspapers;
−Removed: and provisional enforcement of the decision to be issued, which would ensure enforcement of the decision (including any provisional damages) pending appeal.
−Removed: Amgen is not seeking a preliminary injunction in this proceeding at this time.
−Removed: On April 10, 2017, the Company and the Sanofi parties filed briefs seeking invalidation of certain of the claims of the '124 Patent, and Amgen filed a response on July 28, 2017.
−Removed: Oral hearing on this infringement lawsuit (originally scheduled for February 12, 2019) has yet to be rescheduled.
−Removed: The Netherlands.
−Removed: On December 17, 2019, Amgen initiated a lawsuit alleging infringement of the Dutch designation of the '124 Patent in the District Court of The Hague in the Netherlands, against Sanofi-Aventis Netherlands B.V.
−Removed: and Sanofi-Aventis Groupe S.A.
−Removed: The Company has not been named as a defendant in this action.
−Removed: Amgen alleges, among other things, patent infringement based on the production, importation, and commercialization of Praluent (alirocumab) in the Netherlands.
−Removed: Amgen's requests are made on an accelerated basis and include, among other things, a request for a permanent injunction, damages, an order for customer information, a recall order, a destruction order, and an order for costs.
−Removed: A hearing has been scheduled for February 12, 2021.
−Removed: On December 20, 2019, Amgen filed a lawsuit for infringement of the Italian designation of the '124 Patent in the Tribunale di Milano - Enterprise Chamber in Milan, Italy, against Sanofi-Aventis Groupe S.A., Sanofi Chimie, and Sanofi SpA.
−Removed: The Company has not been named as a defendant in this action.
−Removed: Amgen alleges that the production, importation, and commercialization of Praluent (alirocumab) in Italy infringes the '124 Patent.
−Removed: The writ of summons filed by Amgen seeks, among other things, a declaration of infringement, a permanent injunction, withdrawal of product from the market, and damages.
−Removed: On June 24, 2020, Amgen also filed a preliminary injunction motion against the Sanofi parties.
−Removed: On August 12, 2020, the court denied Amgen's preliminary injunction motion.
−Removed: On December 20, 2019, Amgen also filed a lawsuit alleging infringement of the Spanish designation of the '124 Patent in the Juzgado de lo Mercantil No.
−Removed: 5 (Commercial Court) in Barcelona, Spain, against Sanofi-Aventis, S.A.
−Removed: The Company was not named as a defendant in this action.
−Removed: Amgen alleged, among other things, patent infringement based on the manufacture, offering for sale, introduction into the market, use, and importation or possession of Praluent (alirocumab) in Spain.
−Removed: Amgen sought, among other things, a permanent injunction, withdrawal of Praluent from the market, seizure and destruction of Praluent from the market and in storage, and damages in the form of lost profits and costs and expenses.
−Removed: On May 12, 2020, the court stayed this lawsuit until October 30, 2020 on terms mutually agreed by the parties.
−Removed: On October 30, 2020, the stay was automatically lifted.
−Removed: On November 2, 2020, Amgen filed a motion withdrawing this lawsuit;
−Removed: and, on February 1, 2021, the lawsuit was dismissed.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: On May 19, 2017, Amgen filed a lawsuit for infringement of Amgen's Japanese Patent Nos.
−Removed: 5,906,333 (the "'333 Patent") and 5,705,288 (the "'288 Patent") in the Tokyo District Court Civil Division (the "Tokyo District Court") against Sanofi K.K.
−Removed: Amgen's complaint alleges that manufacturing, selling or otherwise transferring, and offering to sell or otherwise transfer Praluent (alirocumab) in Japan (as well as importing Praluent (alirocumab) into Japan) infringe the '333 and '288 Patents.
−Removed: The complaint further seeks a permanent injunction, disposal of product, and court costs.
−Removed: The Company has not been named as a defendant in this litigation.
−Removed: On January 17, 2019, the Tokyo District Court upheld the validity of the '333 Patent and '288 Patent and ordered a permanent injunction against Sanofi K.K.
−Removed: to stop manufacturing, selling or otherwise transferring, and offering to sell or otherwise transfer Praluent (alirocumab) in Japan (as well as importing Praluent (alirocumab) into Japan) and to dispose of all product.
−Removed: However, the Tokyo District Court stayed the enforcement of such injunction pending appeal to the Intellectual Property High Court of Japan (the "IPHC").
−Removed: On January 30, 2019, Sanofi K.K.
−Removed: appealed the Tokyo District Court's decision in the infringement proceedings to the IPHC.
−Removed: Following an oral hearing on October 30, 2019, the IPHC affirmed the Tokyo District Court's decision in the infringement proceedings.
−Removed: appealed the IPHC's decision in the infringement proceedings to the Supreme Court of Japan on November 12, 2019.
−Removed: On April 24, 2020, the Supreme Court of Japan declined to hear the appeal filed by Sanofi K.K.
−Removed: in the infringement proceedings and the injunction issued by the Tokyo District Court became effective.
−Removed: subsequently complied with the injunction and, as a result, the commercialization of Praluent in Japan has been discontinued.
−Removed: On March 31, 2020, Amgen filed a related lawsuit in the Tokyo District Court against Sanofi K.K.
−Removed: seeking damages incurred by Amgen as a result of the finding of infringement of the '333 Patent and the '288 Patent.
+Added: In October 2020, the '124 Patent claims directed to compositions of matter and medical use relevant to Praluent were ruled invalid based on a lack of inventive step by the Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO").
+Added: This decision impacted each of the infringement proceedings based on the '124 Patent discussed below.
+Added: Amgen filed lawsuits in Germany, the United Kingdom, and France in July 2016, July 2016, and September 2016, respectively, against the Company and certain of Sanofi's affiliated entities for infringement of the relevant designation of the '124 Patent in each such jurisdiction;
+Added: and these lawsuits were dismissed in November 2020, September 2021, and June 2021, respectively.
+Added: The dismissal in Germany followed an earlier finding of infringement and granting of an injunction, both of which were subsequently overturned.
+Added: In December 2019, Amgen also filed lawsuits in the Netherlands, Italy, and Spain for infringement of the relevant designation of the '124 Patent in each such jurisdiction;
+Added: the Company was not named as a defendant in any of these actions, and each of these lawsuits was dismissed in February 2021.
+Added: As previously reported, on March 31, 2020, Amgen filed a lawsuit in the Tokyo District Court against Sanofi K.K.
+Added: seeking damages incurred by Amgen as a result of the earlier finding of infringement of Amgen's Japanese Patent Nos.
+Added: 5,906,333 and 5,705,288 by the Tokyo District Court Civil Division.
The Company has not been named as a defendant in this damages action.
2 unchanged sentences
On March 23, 2017, the Company, Sanofi-Aventis U.S.
−Removed: LLC, and Genzyme Corporation filed a lawsuit against Amgen and Immunex Corporation, a wholly owned subsidiary of Amgen, in the United States District Court for the District of Massachusetts seeking a declaratory judgment that the Company's and the other plaintiffs' Commercializing of Dupixent does not directly or indirectly infringe U.S.
−Removed: 8,679,487 (the "'487 Patent") owned by Immunex Corporation relating to antibodies that bind the human interleukin-4 receptor.
−Removed: On May 1, 2017, the Company and the other plaintiffs filed a notice of voluntary dismissal of this action without prejudice.
−Removed: On March 23, 2017, the Company, Sanofi-Aventis U.S.
−Removed: LLC, and Genzyme Corporation initiated an inter partes review ("IPR") in the United States Patent and Trademark Office ("USPTO") seeking a declaration of invalidity of the '487 Patent.
−Removed: On July 28 and 31, 2017, the same parties filed two additional IPR petitions in the USPTO seeking declarations of invalidity of the '487 Patent based on different grounds (the "Additional IPR Petitions").
−Removed: On October 4, 2017, the Patent Trial and Appeal Board ("PTAB") of the USPTO issued a decision on the first IPR petition and declined to institute an IPR proceeding to review the validity of the '487 Patent.
−Removed: On February 15, 2018, the PTAB issued two decisions instituting the Company's and Sanofi's Additional IPR Petitions on all claims of the '487 Patent for which review had been requested.
−Removed: Oral hearings on the Additional IPR Petitions before the PTAB were held on November 14, 2018.
−Removed: On February 14, 2019, the PTAB issued final written decisions on the Additional IPR Petitions, invalidating all 17 claims of the '487 Patent as obvious based on one of the Additional IPR Petitions while declining to hold the challenged claims of the '487 Patent invalid based on the other.
−Removed: In April 2019, the parties filed notices of appeal with the Federal Circuit appealing the PTAB's respective adverse final written decisions on the Additional IPR Petitions, and oral argument was held on August 5, 2020.
−Removed: On October 13, 2020, the Federal Circuit affirmed the PTAB's decision on the Additional IPR Petition that invalidated all 17 claims of the '487 Patent as obvious.
+Added: LLC, and Genzyme Corporation initiated an inter partes review ("IPR") in the United States Patent and Trademark Office ("USPTO") seeking a declaration of invalidity of U.S.
+Added: 8,679,487 (the "'487 Patent") owned by Immunex Corporation relating to antibodies that bind the human interleukin-4 receptor and subsequently filed two additional IPR petitions in the USPTO seeking declarations of invalidity of the '487 Patent based on different grounds (the "Additional IPR Petitions").
+Added: The Patent Trial and Appeal Board ("PTAB") of the USPTO issued a final written decision on the Additional IPR Petitions on February 14, 2019, invalidating all 17 claims of the '487 Patent as obvious.
+Added: This decision was subsequently affirmed by the Federal Circuit and Immunex's petition for writ of certiorari was denied by the United States Supreme Court.
+Added: The '487 Patent expired in May 2020 following Immunex's filing of a terminal disclaimer with the USPTO.
On April 5, 2017, Immunex Corporation filed a lawsuit against the Company, Sanofi, Sanofi-Aventis U.S.
4 unchanged sentences
and attorneys' fees.
−Removed: Immunex is not seeking an injunction in this proceeding at this time.
−Removed: On June 21, 2017, the court denied a motion to dismiss Immunex's complaint previously filed by the Company and the Sanofi parties.
−Removed: On June 28, 2017, the Company and the Sanofi parties filed an answer to Immunex's complaint and counterclaims against Immunex and Amgen (which was amended on October 31, 2017 to, among other things, add an inequitable conduct allegation), and Immunex and Amgen filed an answer to the counterclaims on July 28, 2017.
−Removed: A combined hearing on the construction of certain disputed claim terms of the '487 Patent and the Company and the Sanofi parties' motion for summary judgment on the issue of indefiniteness of the '487 Patent claims was held on July 12, 2018.
−Removed: On August 24, 2018,
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: the court issued an order denying this motion and construed the disputed claim terms as proposed by Amgen.
−Removed: On February 28, 2019, the court granted a joint stipulation by the parties to stay the litigation pending resolution of the appeals of the PTAB's final written decisions on the Additional IPR Petitions discussed above.
+Added: The court subsequently granted a joint stipulation by the parties to stay the litigation pending resolution of the appeals of the PTAB's final written decisions on the Additional IPR Petitions discussed above;
+Added: and, on August 3, 2021, granted a motion to dismiss the lawsuit, dismissing all of Immunex's claims with prejudice.
On September 30, 2016, Sanofi initiated a revocation proceeding in the United Kingdom to invalidate the U.K.
5 unchanged sentences
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.
+Added: Immunex filed a notice of appeal of the EPO's decision on January 31, 2018, and an oral hearing before the TBA has been scheduled for March 10–11, 2022.
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.
−Removed: , a patent that shares the same priority date, disclosure, and patent term of the parent '665 Patent but contains claims to a different invention).
+Added: 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).
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: The original patent term of the Immunex patents is set to expire in 2021.
+Added: Immunex filed a notice of appeal of the EPO's decision on May 31, 2019, and an oral hearing before the TBA has been scheduled for March 10–11, 2022.
+Added: The original patent term of the Immunex patents expired in May 2021.
Proceedings Relating to EYLEA (aflibercept) Injection
On January 7, 2021, Chengdu Kanghong Pharmaceutical Group Co., Ltd.
−Removed: filed an IPR petition in the USPTO against the Company' s U.S.
−Removed: 10,464,992 (the "'992 Patent") and a post-grant review petition against the Company's U.S.
+Added: ("Chengdu Kanghong") filed an IPR petition in the USPTO against the Company' s U.S.
+Added: 10,464,992 (the "'992 Patent") and a post-grant review ("PGR") petition against the Company's U.S.
10,828,345 (the "'345 Patent") seeking declarations of invalidity of the '992 Patent and '345 Patent.
+Added: On June 23, 2021, Chengdu Kanghong filed motions to dismiss each of these petitions and terminate the respective proceedings, which were granted by the USPTO on June 25, 2021.
+Added: On February 11, 2020, anonymous parties filed two requests for ex parte reexamination of the Company's U.S.
+Added: 10,406,226 and the '992 Patent, and the USPTO has granted both requests to initiate reexamination proceedings.
+Added: On May 5, 2021, Mylan Pharmaceuticals Inc.
+Added: filed IPR petitions in the USPTO against the Company's U.S.
+Added: 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.
+Added: On November 10, 2021, the USPTO issued a decision instituting both IPR proceedings.
+Added: On December 9, 2021, Apotex Inc.
+Added: and Celltrion, Inc.
+Added: 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.
+Added: On September 7, 2021, Celltrion, Inc.
+Added: filed a PGR petition in the USPTO against the Company's U.S.
+Added: 10,857,231 (the "'231 Patent") seeking a declaration of invalidity of the '231 Patent.
+Added: On October 26 and October 27, 2021, anonymous parties initiated opposition proceedings in the EPO against the Company's European Patent No.
+Added: 2,944,306 (the "'306 Patent") seeking revocation of the '306 Patent in its entirety.
Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe
4 unchanged sentences
a permanent cease-and-desist order from the importation, sale, offer for sale, advertising, packaging, or solicitation of any sale by the Company of EYLEA PFS or components thereof;
−Removed: and a bond should the Company continue to import EYLEA PFS (if found to infringe) during, if applicable, any 60-day Presidential review period ( i.e.
−Removed: , the period when the President of the United States (or his designee) can disapprove any ITC decision to issue an exclusion order or cease-and-desist order).
−Removed: The ITC instituted the investigation on July 22, 2020 and a trial has been scheduled for April 19-23, 2021.
−Removed: On June 19, 2020, Novartis also filed a patent infringement lawsuit in the U.S.
+Added: and a bond should the Company continue to import EYLEA PFS (if found to infringe) during, if applicable, any 60-day Presidential review period (i.e., the period when the President of the United States (or his designee) can disapprove any ITC decision to issue an exclusion order or cease-and-desist order).
+Added: The ITC instituted the investigation on July 22, 2020 and a trial was scheduled for April 19–23, 2021.
+Added: 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.
+Added: On April 8, 2021, Novartis moved to terminate the ITC investigation in its entirety based on its withdrawal of the complaint;
+Added: and, on May 3, 2021, the ITC terminated the investigation.
+Added: On June 19, 2020, Novartis also filed a patent infringement lawsuit (as amended on August 2, 2021) in the U.S.
District Court for the Northern District of New York asserting claims of 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), treble damages, costs and expenses of the lawsuits, and attorneys' fees.
+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 lawsuits, and attorneys' fees.
On July 30, 2020, the court granted the Company's motion to stay these proceedings until a determination in the ITC proceedings discussed above, including any appeals therefrom, becomes final.
+Added: On June 11, 2021, the court, at the request of Novartis, lifted the stay.
+Added: On November 5, 2021, the Company filed a motion to stay these proceedings in light of the pending IPR proceeding discussed below.
+Added: On January 31, 2022, the court denied the Company's motion to stay these proceedings.
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.
1 unchanged sentence
the other IPR petition has been withdrawn.
+Added: 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.
+Added: On October 26, 2021, the USPTO issued a decision instituting the IPR proceeding.
On July 17, 2020, the Company filed an antitrust lawsuit against Novartis and Vetter Pharma International Gmbh ("Vetter") in the United States District Court for the Southern District of New York seeking a declaration that the '631 Patent is unenforceable and a judgment that the defendants' conduct violates Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act").
2 unchanged sentences
and on October 19, 2020, Novartis filed, and Vetter moved to join, a second motion to dismiss the complaint on different grounds.
−Removed: On January 25, 2021, the Company filed an amended complaint seeking a judgment
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: that the Novartis's conduct violates Section 2 of the Sherman Antitrust Act based on additional grounds, as well as a judgment of tortious interference with contract.
+Added: On January 25, 2021, the Company filed an amended complaint seeking a judgment that Novartis's conduct violates Section 2 of the Sherman Antitrust Act based on additional grounds, as well as a judgment of tortious interference with contract.
+Added: On February 22, 2021, Novartis filed, and Vetter moved to join, a motion to dismiss the amended complaint.
+Added: On September 21, 2021, the court granted Novartis and Vetter's motion to transfer this lawsuit to the Northern District of New York.
+Added: As a result, this lawsuit was transferred to the same judge that had been assigned to the patent infringement lawsuit discussed above.
+Added: On November 5, 2021, the Company filed a motion to stay these proceedings in light of the pending IPR proceeding
+Added: discussed above.
+Added: On January 31, 2022, the court denied the Company's motion to stay these proceedings and granted Novartis and Vetter's motion to dismiss the amended complaint.
Proceedings Related to "Most Favored Nation" Interim Final Rule
On December 11, 2020, the Company filed a lawsuit in the United States District Court for the Southern District of New York against the U.S.
−Removed: Department of Health and Human Services, the Secretary of HHS, the Centers for Medicare & Medicaid Services ("CMS"), and the Administrator of CMS seeking declaratory and injunctive relief related to the interim final rule with comment period entitled "Most Favored Nation (MFN) Model" issued on November 20, 2020 by HHS, acting through CMS.
+Added: Department of Health and Human Services, the Secretary of HHS, the Centers for Medicare & Medicaid Services ("CMS"), and the Administrator of CMS seeking declaratory and injunctive relief related to the interim final rule with comment period entitled "Most Favored Nation (MFN) Model" issued on November 20, 2020 by HHS, acting through CMS (the "MFN Rule").
On the same day, the Company filed a motion for a preliminary injunction and temporary restraining order, seeking to prevent implementation of the MFN Rule.
2 unchanged sentences
On February 2, 2021, the government stated to the court that the Solicitor General had determined not to appeal the preliminary injunction.
+Added: On February 10, 2021, the court entered a 90-day stay of the litigation and subsequently extended the stay, with the most recent 60-day extension granted on January 4, 2022.
+Added: On December 27, 2021, CMS published a final rule that rescinds the MFN Rule effective February 28, 2022.
Proceedings Relating to fasinumab
7 unchanged sentences
On December 15, 2020, Rinat filed an amended defense and counterclaim seeking a declaration of infringement of the '711 Patent by fasinumab.
−Removed: A trial has been scheduled to commence in late November or early December 2021.
+Added: On May 5, 2021, the court stayed this litigation on terms mutually agreed by the parties.
The '048 Patent is subject to opposition proceedings in the EPO, which were initiated by the Company on August 10, 2016 and two other opponents on August 11, 2016.
3 unchanged sentences
On October 21, 2020, Teva filed a notice of intervention with the TBA to take part in the appeal proceedings as an intervener.
+Added: An oral hearing before the TBA has been scheduled for April 5–6, 2022.
The '711 Patent is also subject to opposition proceedings in the EPO, which were initiated by the Company on May 1, 2018.
2 unchanged sentences
The Company filed a notice of appeal to the TBA on December 20, 2019.
−Removed: An oral hearing before the TBA has been scheduled for July 29, 2021.
On January 29, 2021, Teva filed a notice of intervention with the TBA to take part in the appeal proceedings as an intervener.
+Added: An oral hearing before the TBA was held on July 29, 2021, at which the '711 Patent was revoked in its entirety.
Proceedings Relating to REGEN-COV (casirivimab and imdevimab)
On October 5, 2020, Allele Biotechnology and Pharmaceuticals, Inc.
−Removed: ("Allele") filed a lawsuit against the Company in the United States District Court for the Southern District of New York, asserting infringement of U.S.
+Added: ("Allele") filed a lawsuit (as amended on April 8, 2021) against the Company in the United States District Court for the Southern District of New York, asserting infringement of U.S.
10,221,221 (the "'221 Patent").
−Removed: Allele seeks a judgment of patent infringement of the '221 Patent, a judgment that such infringement was willful, and an award of monetary damages (together with interest), treble damages, costs and expenses of the lawsuit, and attorneys' fees.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
+Added: Allele seeks a judgment of patent infringement of the '221 Patent, an award of monetary damages (together with interest), an order of willful infringement of the '221 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuit, and attorneys' fees.
+Added: On July 16, 2021, the Company filed a motion to dismiss the complaint.
+Added: An oral hearing has been scheduled for March 2, 2022.
Department of Justice Matters
11 unchanged sentences
The CIDs relate to EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present.
+Added: 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.
+Added: LLC by two qui tam plaintiffs (known as relators) purportedly on behalf the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law.
+Added: Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case.
+Added: On October 29, 2021, the qui tam plaintiffs filed an amended complaint in this matter.
+Added: On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety.
+Added: In June 2021, the Company received a CID from the U.S.
+Added: Department of Justice pursuant to the federal False Claims Act.
+Added: 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;
+Added: and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to CMS.
+Added: The CID covers the period from January 2011 through June 2021.
The Company is cooperating with this investigation.
3 unchanged sentences
Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.
−Removed: UHC alleges causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act and seeks monetary damages and equitable relief.
+Added: UHC alleges causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act (the "RICO Act") and seeks monetary damages and equitable relief.
+Added: On March 1, 2021, the Company filed a motion to dismiss the complaint in its entirety.
+Added: On March 25, 2021, UHC filed an amended complaint;
+Added: and, on April 22, 2021, the Company filed a motion to dismiss this amended complaint in its entirety.
+Added: On December 29, 2021, this lawsuit was stayed pending resolution of the proceedings before the U.S.
+Added: District Court for the District of Massachusetts discussed under "Department of Justice Matters" above.
+Added: Proceedings Initiated by Humana
+Added: On July 22, 2021, Humana Inc.
+Added: ("Humana") filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging Humana has been damaged by the conduct alleged in the civil complaint filed by the U.S.
+Added: Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.
+Added: Humana alleges causes of action under state law and the RICO Act and seeks monetary damages and equitable relief.
+Added: On September 27, 2021, the Company filed a motion to dismiss the complaint in its entirety.
+Added: On December 29, 2021, this lawsuit was stayed pending resolution of the proceedings before the U.S.
+Added: District Court for the District of Massachusetts discussed under "Department of Justice Matters" above.
+Added: Proceedings Initiated by Blue Cross and Blue Shield
+Added: On December 20, 2021, Blue Cross and Blue Shield of Massachusetts, Inc.
+Added: and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc.
+Added: (collectively, "BCBS") filed a lawsuit against the Company in the U.S.
+Added: District Court for the District of Massachusetts alleging BCBS has been damaged by the conduct alleged in the civil complaint filed by the U.S.
+Added: Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.
+Added: BCBS alleges causes of action under state law and the RICO Act and seeks monetary damages and equitable relief.
Shareholder Demand
6 unchanged sentences
The Company's board of directors, working with outside counsel, investigated and evaluated the allegations in the demand letter and has concluded that pursuing the claims alleged in the demand would not be in the Company's best interests at this time.
+Added: Proceedings Relating to Shareholder Derivative Complaint
+Added: On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current and certain former members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant.
+Added: The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the civil complaint filed by the U.S.
+Added: Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above.
+Added: The complaint seeks an award of damages allegedly sustained by the Company;
+Added: an order requiring Regeneron to take all necessary actions to reform and improve its corporate governance and internal procedures;
+Added: disgorgement from the individual defendants of all profits and benefits obtained by them resulting from their sales of Regeneron stock;
+Added: and costs and disbursements of the action, including attorneys' fees.
+Added: On July 28, 2021, the defendants filed a notice of removal, removing the case from the New York Supreme Court to the U.S.
+Added: District Court for the Southern District of New York.
+Added: On September 24, 2021, the individual defendants moved to dismiss the complaint in its entirety.
+Added: Also on September 24, 2021, the plaintiff filed a motion to remand the case to the New York Supreme Court.
Net Income Per Share
1 unchanged sentence
Year Ended December 31,
−Removed: 2020 2019 2018
+Added: (In millions, except per share data) 2021 2020 2019
Net income - basic and diluted $ 8,075.3 $ 3,513.2 $ 2,115.8
−Removed: (Shares in millions)
Weighted average shares - basic 105.7 107.6 109.2
1 unchanged sentence
Stock options 5.4 7.0 5.4
−Removed: Restricted stock 0.5 — —
+Added: Restricted stock awards and restricted stock units 1.1 0.5 —
Weighted average shares - diluted 112.2 115.1 114.6
1 unchanged sentence
Net income per share - diluted $ 71.97 $ 30.52 $ 18.46
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following:
4 unchanged sentences
The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Consolidated Balance Sheet to the total of the same such amounts shown in the Consolidated Statement of Cash Flows:
−Removed: 2020 2019 2018
+Added: (In millions) 2021 2020 2019
Cash and cash equivalents $ 2,885.6 $ 2,193.7 $ 1,617.8
6 unchanged sentences
Included in accounts payable, accrued expenses, and other liabilities as of December 31, 2021, 2020, and 2019 were $ 74.8 million, $ 83.6 million, and $ 133.7 million, respectively, of accrued capital expenditures.
−Removed: As described in Note 11, during 2020, 2019, and 2018, we purchased (by issuing a credit towards the amount owed by Sanofi) shares of our Common Stock from Sanofi to satisfy Sanofi's funding obligation related to Libtayo development costs.
−Removed: REGENERON PHARMACEUTICALS, INC.
−Removed: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
−Removed: (Unless otherwise noted, dollars in millions, except per share data)
−Removed: Unaudited Quarterly Results
−Removed: Summarized quarterly financial data (unaudited) for the years ended December 31, 2020 and 2019 are set forth in the following tables.
−Removed: Certain revisions have been made to the previously reported 2019 quarterly amounts below in connection with changing the presentation of certain amounts earned from collaborators (see Note 1 for further details).
−Removed: First Quarter Ended
−Removed: March 31, 2020 Second Quarter Ended
−Removed: June 30, 2020 (1)
−Removed: Third Quarter Ended
−Removed: September 30, 2020 Fourth Quarter Ended
−Removed: December 31, 2020 (2)
−Removed: Revenues $ 1,828.2 $ 1,952.0 $ 2,294.0 $ 2,422.9
−Removed: Operating expenses $ 1,128.1 $ 1,295.6 $ 1,240.9 $ 1,255.9
−Removed: Net income $ 624.6 $ 897.3 $ 842.1 $ 1,149.2
−Removed: Net income per share - basic $ 5.69 $ 8.19 $ 7.98 $ 10.90
−Removed: Net income per share - diluted $ 5.43 $ 7.61 $ 7.39 $ 10.24
−Removed: First Quarter Ended
−Removed: March 31, 2019 Second Quarter Ended
−Removed: June 30, 2019 (3)
−Removed: Third Quarter Ended
−Removed: September 30, 2019 Fourth Quarter Ended
−Removed: December 31, 2019
−Removed: Revenues $ 1,372.6 $ 1,577.8 $ 1,743.7 $ 1,863.5
−Removed: Operating expenses $ 892.6 $ 1,262.2 $ 1,005.2 $ 1,187.8
−Removed: Net income $ 461.1 $ 193.1 $ 669.6 $ 792.0
−Removed: Net income per share - basic $ 4.23 $ 1.77 $ 6.12 $ 7.25
−Removed: Net income per share - diluted $ 3.99 $ 1.68 $ 5.86 $ 6.93
−Removed: (1) Included in operating expenses (specifically, research and development expenses) were $ 85.0 million in up-front payments in connection with our collaboration agreement with Intellia.
−Removed: (2) Included in operating expenses was (i) the recognition of cumulative catch-up adjustments of $ 99.8 million, net, in other operating income related to updates to estimates of the total research and development costs expected to be incurred for certain collaboration agreements (see Note 3), as well as (ii) a reversal of $ 95.0 million within selling, general, and administrative expenses for litigation-related loss contingency accruals in connection with proceedings for Praluent outside the United States (see Note 15).
−Removed: (3) Included in operating expenses (specifically, research and development expenses) was a $ 400.0 million up-front payment in connection with our collaboration agreement with Alnylam.
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.