Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In millions, except share data)
June 30, December 31,
2021 2020
ASSETS
Current assets:
Cash and cash equivalents $ 2,072.2 $ 2,193.7
Marketable securities 1,838.6 1,393.3
Accounts receivable, net 6,998.6 4,114.7
Inventories 1,983.9 1,916.6
Prepaid expenses and other current assets 444.3 160.8
Total current assets 13,337.6 9,779.1
Marketable securities 3,900.3 3,135.6
Property, plant, and equipment, net 3,358.5 3,221.6
Deferred tax assets 746.6 858.9
Other noncurrent assets 142.9 168.1
Total assets $ 21,485.9 $ 17,163.3
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 476.0 $ 475.5
Accrued expenses and other current liabilities 2,018.0 1,644.2
Finance lease liabilities 718.4 —
Deferred revenue 520.0 577.7
Total current liabilities 3,732.4 2,697.4
Long-term debt 1,979.2 1,978.5
Finance lease liabilities — 717.2
Deferred revenue 50.7 57.8
Other noncurrent liabilities 596.3 687.1
Total liabilities 6,358.6 6,138.0
Stockholders' equity:
Preferred Stock, $ .01 par value; 30,000,000 shares authorized; issued and outstanding - no ne
— —
Class A Stock, convertible, $ .001 par value; 40,000,000 shares authorized; shares issued and outstanding - 1,848,970 i n 2021 and 2020
— —
Common Stock, $ .001 par value; 320,000,000 shares authorized; shares issued - 122,527,112 in 2021 and 121,533,460 in 2020
0.1 0.1
Additional paid-in capital 7,225.8 6,716.2
Retained earnings 15,107.1 10,893.0
Accumulated other comprehensive income 15.7 29.3
Treasury Stock, at cost; 17,656,256 shares in 2021 and 16,431,520 shares in 2020
( 7,221.4 ) ( 6,613.3 )
Total stockholders' equity 15,127.3 11,025.3
Total liabilities and stockholders' equity $ 21,485.9 $ 17,163.3
The accompanying notes are an integral part of the financial statements.
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REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Unaudited)
(In millions, except per share data)
Three Months Ended
June 30, Six Months Ended
June 30,
2021 2020 2021 2020
Statements of Operations
Revenues:
Net product sales $ 4,137.8 $ 1,226.9 $ 5,862.1 $ 2,463.6
Collaboration revenue 954.7 513.3 1,709.1 1,041.6
Other revenue 46.0 211.8 96.0 275.0
5,138.5 1,952.0 7,667.2 3,780.2
Expenses:
Research and development 714.2 722.0 1,457.1 1,305.9
Selling, general, and administrative 414.7 348.3 820.3 715.6
Cost of goods sold 539.4 102.5 722.6 181.3
Cost of collaboration and contract manufacturing 154.3 173.0 279.1 311.5
Other operating (income) expense, net ( 31.3 ) ( 50.2 ) ( 71.8 ) ( 90.6 )
1,791.3 1,295.6 3,207.3 2,423.7
Income from operations 3,347.2 656.4 4,459.9 1,356.5
Other income (expense):
Other income (expense), net 420.0 272.2 574.9 246.8
Interest expense ( 14.4 ) ( 9.7 ) ( 29.0 ) ( 15.8 )
405.6 262.5 545.9 231.0
Income before income taxes 3,752.8 918.9 5,005.8 1,587.5
Income tax expense 653.9 21.6 791.7 65.6
Net income $ 3,098.9 $ 897.3 $ 4,214.1 $ 1,521.9
Net income per share - basic $ 29.51 $ 8.19 $ 40.06 $ 13.87
Net income per share - diluted $ 27.97 $ 7.61 $ 38.07 $ 13.03
Weighted average shares outstanding - basic 105.0 109.6 105.2 109.7
Weighted average shares outstanding - diluted 110.8 117.9 110.7 116.8
Statements of Comprehensive Income
Net income $ 3,098.9 $ 897.3 $ 4,214.1 $ 1,521.9
Other comprehensive income (loss), net of tax:
Unrealized (loss) gain on debt securities ( 0.8 ) 44.6 ( 14.1 ) 15.8
Unrealized gain (loss) on cash flow hedges 0.3 — 0.5 ( 1.4 )
Comprehensive income $ 3,098.4 $ 941.9 $ 4,200.5 $ 1,536.3
The accompanying notes are an integral part of the financial statements.
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REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited)
(In millions)
Class A Stock Common Stock Additional Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity
Shares Amount Shares Amount Shares Amount
Balance, December 31, 2020 1.8 — 121.5 $ 0.1 $ 6,716.2 $ 10,893.0 $ 29.3 ( 16.4 ) $ ( 6,613.3 ) $ 11,025.3
Issuance of Common Stock for equity awards granted under long-term incentive plans
— — 0.5 — 93.9 — — — — 93.9
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations
— — ( 0.1 ) — ( 66.4 ) — — — — ( 66.4 )
Issuance/distribution of Common Stock for 401(k) Savings Plan
— — — — 8.5 — — — 1.5 10.0
Repurchases of Common Stock
— — — — — — — ( 0.7 ) ( 323.5 ) ( 323.5 )
Stock-based compensation charges — — — — 135.6 — — — — 135.6
Net income — — — — — 1,115.2 — — — 1,115.2
Other comprehensive loss, net of tax — — — — — — ( 13.1 ) — — ( 13.1 )
Balance, March 31, 2021 1.8 — 121.9 0.1 6,887.8 12,008.2 16.2 ( 17.1 ) ( 6,935.3 ) 11,977.0
Issuance of Common Stock for equity awards granted under long-term incentive plans
— — 0.7 — 216.6 — — — — 216.6
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations
— — ( 0.1 ) — ( 26.1 ) — — — — ( 26.1 )
Issuance/distribution of Common Stock for 401(k) Savings Plan
— — — — 11.6 — — — 2.5 14.1
Repurchases of Common Stock
— — — — — — — ( 0.6 ) ( 288.6 ) ( 288.6 )
Stock-based compensation charges — — — — 135.9 — — — — 135.9
Net income — — — — — 3,098.9 — — — 3,098.9
Other comprehensive loss, net of tax — — — — — — ( 0.5 ) — — ( 0.5 )
Balance, June 30, 2021 1.8 — 122.5 $ 0.1 $ 7,225.8 $ 15,107.1 $ 15.7 ( 17.7 ) $ ( 7,221.4 ) $ 15,127.3
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CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) (continued)
Class A Stock Common Stock Additional Paid-in Capital Retained Earnings Accumulated Other Comprehensive Income (Loss) Treasury Stock Total Stockholders' Equity
Shares Amount Shares Amount Shares Amount
Balance, December 31, 2019 1.8 — 113.3 $ 0.1 $ 4,428.6 $ 7,379.8 $ 21.1 ( 4.9 ) $ ( 739.9 ) $ 11,089.7
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 3.1 — 817.4 — — — — 817.4
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.4 ) — ( 155.1 ) — — — — ( 155.1 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 12.5 — — — 2.1 14.6
Repurchases of Common Stock — — — — — — — ( 0.8 ) ( 336.0 ) ( 336.0 )
Stock-based compensation charges — — — — 108.0 — — — — 108.0
Net income — — — — — 624.6 — — — 624.6
Other comprehensive loss, net of tax — — — — — — ( 30.2 ) — — ( 30.2 )
Balance, March 31, 2020 1.8 — 116.0 0.1 5,211.4 8,004.4 ( 9.1 ) ( 5.7 ) ( 1,073.8 ) 12,133.0
Issuance of Common Stock for equity awards granted under long-term incentive plans
— — 4.4 — 1,355.5 — — — — 1,355.5
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations
— — ( 0.6 ) — ( 416.5 ) — — — — ( 416.5 )
Issuance/distribution of Common Stock for 401(k) Savings Plan
— — — — 7.4 — — — 2.7 10.1
Repurchases of Common Stock
— — — — — — — ( 9.9 ) ( 5,071.8 ) ( 5,071.8 )
Stock-based compensation charges
— — — — 105.2 — — — — 105.2
Net income
— — — — — 897.3 — — — 897.3
Other comprehensive income, net of tax
— — — — — — 44.6 — — 44.6
Balance, June 30, 2020 1.8 — 119.8 $ 0.1 $ 6,263.0 $ 8,901.7 $ 35.5 ( 15.6 ) $ ( 6,142.9 ) $ 9,057.4
The accompanying notes are an integral part of the financial statements.
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REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(In millions)
Six Months Ended
June 30,
2021 2020
Cash flows from operating activities:
Net income $ 4,214.1 $ 1,521.9
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 138.5 114.9
Non-cash compensation expense 276.4 209.3
Gains on marketable and other securities, net ( 553.9 ) ( 199.6 )
Other non-cash items, net 192.6 23.8
Deferred taxes 51.8 118.0
Changes in assets and liabilities:
Increase in accounts receivable ( 2,883.9 ) ( 47.1 )
Increase in inventories ( 221.5 ) ( 233.4 )
(Increase) decrease in prepaid expenses and other assets ( 277.8 ) 33.8
(Decrease) increase in deferred revenue ( 64.8 ) 78.9
Increase in accounts payable, accrued expenses, and other liabilities 423.7 20.9
Total adjustments ( 2,918.9 ) 119.5
Net cash provided by operating activities 1,295.2 1,641.4
Cash flows from investing activities:
Purchases of marketable and other securities ( 1,886.5 ) ( 1,533.5 )
Sales or maturities of marketable and other securities 1,217.1 2,843.7
Capital expenditures ( 263.8 ) ( 300.0 )
Net cash (used in) provided by investing activities ( 933.2 ) 1,010.2
Cash flows from financing activities:
Proceeds from bridge loan facility — 1,500.0
Proceeds from issuance of Common Stock 308.2 2,168.0
Payments in connection with Common Stock tendered for employee tax obligations ( 180.7 ) ( 571.6 )
Repurchases of Common Stock ( 612.1 ) ( 5,373.6 )
Net cash used in financing activities ( 484.6 ) ( 2,277.2 )
Net (decrease) increase in cash, cash equivalents, and restricted cash ( 122.6 ) 374.4
Cash, cash equivalents, and restricted cash at beginning of period 2,207.3 1,630.3
Cash, cash equivalents, and restricted cash at end of period $ 2,084.7 $ 2,004.7
The accompanying notes are an integral part of the financial statements.
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REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. Interim Financial Statements
Basis of Presentation
The interim Condensed Consolidated Financial Statements of Regeneron Pharmaceuticals, Inc. and its subsidiaries ("Regeneron," "Company," "we," "us," and "our") have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company's financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America. In the opinion of management, these financial statements reflect all normal recurring adjustments and accruals necessary for a fair statement of the Company's condensed consolidated financial statements for such periods. The results of operations for any interim period are not necessarily indicative of the results for the full year. The December 31, 2020 Condensed Consolidated Balance Sheet data were derived from audited financial statements, but do not include all disclosures required by accounting principles generally accepted in the United States of America. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.
Certain reclassifications have been made to prior period amounts to conform with the current period's presentation.
2. Product Sales
Net product sales consist of the following:
(In millions) Three Months Ended
June 30, Six Months Ended
June 30,
Net Product Sales in the United States
2021 2020 2021 2020
EYLEA ®
$ 1,424.7 $ 1,113.7 $ 2,771.7 $ 2,285.7
Libtayo ®
78.0 63.3 147.1 125.0
Praluent ®
41.9 47.2 85.2 47.2 *
REGEN-COV™
2,591.2 — 2,853.4 —
Evkeeza ®
2.0 — 2.5 —
ARCALYST ®
— ** 2.7 2.2 ** 5.7
$ 4,137.8 $ 1,226.9 $ 5,862.1 $ 2,463.6
* Effective April 1, 2020, the Company became solely responsible for the development and commercialization of Praluent in the United States and records net product sales of Praluent in the United States. Previously, Sanofi recorded net product sales of Praluent in the United States. See Note 3 for further details.
** Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States. Previously, the Company recorded net product sales of ARCALYST in the United States.
As of June 30, 2021 and December 31, 2020, the Company had $ 5.881 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 the three and six months ended June 30, 2021 and 2020. Sales to each of these customers as a percentage of the Company's total gross product revenue are as follows:
Three Months Ended
June 30, Six Months Ended
June 30,
2021 2020 2021 2020
Besse Medical, a subsidiary of AmerisourceBergen Corporation
22 % 53 % 30 % 53 %
McKesson Corporation 14 % 32 % 19 % 34 %
U.S. Government (see Note 3) 57 % — 43 % —
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3. Collaboration, License, and Other Agreements
a. Sanofi
Amounts recognized in our Statements of Operations in connection with our collaborations with Sanofi are detailed below:
Statement of Operations Classification Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2021 2020 2021 2020
Antibody:
Regeneron's share of profits in connection with commercialization of antibodies Collaboration revenue $ 327.6 $ 171.9 $ 588.2 $ 342.8
Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 110.9 $ 100.6 $ 216.5 $ 180.7
Reimbursement of research and development expenses Reduction of Research and development expense $ 46.5 $ 51.3 $ 77.1 $ 128.9
Regeneron's obligation for its share of Sanofi research and development expenses Research and development expense $ ( 10.6 ) $ ( 24.9 ) $ ( 22.5 ) $ ( 41.6 )
Reimbursement of commercialization-related expenses Reduction of Selling, general, and administrative expense $ 78.3 $ 86.0 $ 137.9 $ 177.2
Immuno-oncology:
Regeneron's share of losses in connection with commercialization of Libtayo outside the United States Collaboration revenue $ ( 3.5 ) $ ( 6.4 ) $ ( 9.6 ) $ ( 12.6 )
Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 2.7 $ 3.0 $ 7.4 $ 5.1
Reimbursement of research and development expenses Reduction of Research and development expense $ 22.5 $ 47.0 $ 44.4 $ 86.9
Reimbursement of commercialization-related expenses Reduction of Selling, general, and administrative expense $ 20.7 $ 14.3 $ 39.2 $ 24.7
Regeneron's obligation for its share of Sanofi commercial expenses Selling, general, and administrative expense $ ( 10.9 ) $ ( 4.4 ) $ ( 18.6 ) $ ( 8.9 )
Regeneron's obligation for Sanofi's share of Libtayo U.S. gross profits Cost of goods sold $ ( 34.4 ) $ ( 28.2 ) $ ( 64.8 ) $ ( 55.0 )
Amounts recognized in connection with up-front payments received Other operating income $ 20.7 $ 20.5 $ 43.6 $ 37.0
Antibody
The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration"), which currently consists of Dupixent ® (dupilumab), Kevzara ® (sarilumab), and itepekimab . Under the terms of the Antibody License and Collaboration Agreement ("LCA"), Sanofi is generally responsible for funding 80 %– 100 % of agreed-upon development costs.
Sanofi leads commercialization activities for products under the Antibody Collaboration, subject to the Company's right to co-commercialize such products. In addition to profit and loss sharing, the Company is entitled to receive sales milestone payments from Sanofi.
The following table summarizes contract balances in connection with the Company's Antibody Collaboration with Sanofi:
June 30, December 31,
(In millions) 2021 2020
Accounts receivable, net $ 474.7 $ 407.7
Deferred revenue
$ 459.0 $ 347.7
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In April 2020, the Company and Sanofi entered into an amendment to the LCA in connection with, among other things, the removal of Praluent from the LCA such that (i) effective April 1, 2020, the LCA no longer governs the development, manufacture, or commercialization of Praluent and (ii) the quarterly period ended March 31, 2020 was the last quarter for which Sanofi and the Company shared profits and losses for Praluent under the LCA. The parties also entered into a Praluent Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, became solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, became solely responsible for the development and commercialization of Praluent outside of the United States. Under the Praluent Agreement, Sanofi will pay the Company a 5 % royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032. The Company will not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States. Although each party will be responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period, the Company will continue to supply drug substance to Sanofi and Sanofi will continue to supply finished product to Regeneron.
With respect to any intellectual property or product liability litigation relating to Praluent, the parties have agreed that, effective April 1, 2020, Regeneron and Sanofi each will be solely responsible for any such litigation (including damages and other costs and expenses thereof) in the United States and outside the United States, respectively, arising out of Praluent sales or other activities on or after April 1, 2020 (subject to Sanofi's right to set off a portion of any third-party royalty payments resulting from certain patent litigation proceedings against up to 50 % of any Praluent royalty payment owed to Regeneron). The parties will each bear 50 % of any damages arising out of Praluent sales or other activities prior to April 1, 2020. See Note 12 for discussion of legal proceedings related to Praluent.
Immuno-Oncology
The Company is party to a collaboration with Sanofi to research, develop, and commercialize antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").
Effective December 31, 2018, the Company and Sanofi entered into an Amended and Restated Immuno-oncology Discovery and Development Agreement ("Amended IO Discovery Agreement"), which narrowed the scope of the existing discovery and development activities conducted by the Company under the 2015 IO Discovery Agreement to developing therapeutic bispecific antibodies targeting (i) BCMA and CD3 (the "BCMAxCD3 Program") and (ii) MUC16 and CD3 (the "MUC16xCD3 Program") through clinical proof-of-concept. During the first quarter of 2021, Sanofi did not exercise its options to license rights to these product candidates; as a result, we retain the exclusive right to develop and commercialize such product candidates and Sanofi will receive a royalty on sales (if any). In addition, the Company has no further obligations to develop drug product candidates under the Amended IO Discovery Agreement.
Under the terms of the Immuno-oncology 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). The parties share equally, on an ongoing basis, agreed-upon development and commercialization expenses for Libtayo. 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. The parties share equally in profits and losses in connection with the commercialization of Libtayo.
The following table summarizes contract balances in connection with the Company's IO Collaboration with Sanofi:
June 30, December 31,
(In millions) 2021 2020
Accounts receivable, net
$ ( 6.8 ) $ ( 6.5 )
Deferred revenue
$ 11.4 $ 10.7
Other liabilities
$ 238.0 $ 280.9
Other liabilities include up-front payments received from Sanofi for which recognition has been deferred.
The aggregate amount of the estimated consideration under the IO Collaboration related to the Company's obligation that was unsatisfied (or partially unsatisfied) as of June 30, 2021 was $ 474.4 million. This amount is expected to be recognized over the remaining period in which the Company is obligated to satisfy its obligation in connection with performing development activities.
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b. Bayer
The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA outside the United States. All agreed upon EYLEA development expenses incurred by the Company and Bayer are shared equally. 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. 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 sales of EYLEA.
Amounts recognized in our Statements of Operations in connection with our Bayer EYLEA collaboration are as follows:
Statement of Operations Classification Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2021 2020 2021 2020
Regeneron's net profit in connection with commercialization of EYLEA outside the United States
Collaboration revenue $ 335.4 $ 230.9 $ 644.3 $ 484.7
Reimbursement for manufacturing of commercial supplies
Collaboration revenue $ 13.7 $ 13.3 $ 27.6 $ 40.9
Reimbursement of research and development expenses
Reduction of Research and development expense
$ 9.9
$ 10.8 $ 20.7 $ 22.8
Regeneron's obligation for its share of Bayer research and development expenses
Research and development expense
$ ( 10.9 ) $ ( 5.3 ) $ ( 23.4 ) $ ( 13.4 )
The following table summarizes contract balances in connection with our Bayer EYLEA collaboration:
June 30, December 31,
(In millions) 2021 2020
Accounts receivable, net $ 342.3 $ 336.2
Deferred revenue
$ 98.8 $ 99.7
c. Teva
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. The Company leads global development activities, and the parties share development costs equally, on an ongoing basis, under a global development plan.
Amounts recognized in our Statements of Operations in connection with our collaboration with Teva are as follows:
Statement of Operations Classification Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2021 2020 2021 2020
Reimbursement of research and development expenses
Reduction of Research and development expense
$ 11.7 $ 31.0 $ 31.5 $ 56.2
Amounts recognized in connection with up-front and development milestone payments received
Other operating income
$ 7.2 $ 20.7 $ 19.4 $ 37.3
The following table summarizes contract balances in connection with the Teva Collaboration Agreement:
June 30, December 31,
(In millions) 2021 2020
Accounts receivable, net $ 11.6 $ 27.7
Other liabilities
$ 47.2 $ 66.8
Other liabilities include up-front and development milestone payments received from Teva for which recognition has been deferred.
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The aggregate amount of the estimated consideration under the Teva Collaboration Agreement related to the Company's obligation that was unsatisfied (or partially unsatisfied) as of June 30, 2021 was $ 105.1 million. This amount is expected to be recognized over the remaining period in which the Company is obligated to satisfy its obligation in connection with performing development activities.
d. U.S. Government
REGEN-COV (casirivimab and imdevimab)
In the first quarter of 2020, we announced an expansion of our Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S. Department of Health and Human Services ("HHS") was obligated to fund certain of our costs incurred for research and development activities related to COVID-19 treatments.
In July 2020, we entered into an agreement with entities acting at the direction of BARDA and the U.S. Department of Defense to manufacture and deliver filled and finished drug product of REGEN-COV to the U.S. government.
In January 2021, the Company announced an agreement with an entity acting on behalf of the U.S. Department of Defense and HHS to manufacture and deliver additional filled and finished drug product of REGEN-COV to the U.S. government. Pursuant to the agreement, the U.S. government was obligated to purchase all filled and finished doses of drug product delivered by June 30, 2021, and agreed to acquire such doses at the lowest treatment dose authorized or approved by the FDA for the indication authorized under the Emergency Use Authorization ("EUA").
The Company has completed its final deliveries of drug product under the agreements described above. See Note 2 for REGEN-COV net product sales recognized in connection with these agreements during the three and six months ended June 30, 2021.
e. Roche
In August 2020, we entered into a collaboration agreement (the "Roche Collaboration Agreement") with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve ™ in other countries). We lead global development activities for casirivimab and imdevimab, and the parties jointly fund certain ongoing studies, as well as any mutually agreed additional new global studies to evaluate further the potential of casirivimab and imdevimab in treating or preventing COVID-19.
Under the terms of the agreement, each party is obligated to dedicate a certain amount of manufacturing capacity to casirivimab and imdevimab each year. We distribute the product in the United States and Roche distributes the product outside of the United States. The parties share gross profits from worldwide sales based on a pre-specified formula, depending on the amount of manufactured product supplied by each party to the market.
Amounts recognized in our Statements of Operations in connection with the Roche Collaboration Agreement are as follows:
Statement of Operations Classification Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2021 2020 2021 2020
Regeneron's share of gross profits in connection with sales of casirivimab and imdevimab Collaboration revenue $ 167.9 — $ 234.7 —
Reimbursement of research and development expenses Reduction of Research and development expense $ 41.0 — $ 127.8 —
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The following table summarizes contract balances in connection with the Roche Collaboration Agreement:
June 30, December 31,
(In millions) 2021 2020
Accounts receivable, net $ 209.2 $ 77.1
f. Intellia
In 2016, we entered into a license and collaboration agreement with Intellia Therapeutics, Inc. to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development. 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.
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. In addition, we also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products. In connection with the agreement, we made a $ 70.0 million up-front payment and purchased 925,218 shares of Intellia common stock for an aggregate purchase price of $ 30.0 million. The up-front payment and the amount paid in excess of the fair market value of the shares purchased, or $ 15.0 million, were recorded to Research and development expense during the three months ended June 30, 2020.
4. Net Income Per Share
Basic net income per share is computed by dividing net income by the weighted average number of shares of Common Stock and Class A Stock outstanding. Net income per share is presented on a combined basis, inclusive of Common Stock and Class A Stock outstanding, as each class of stock has equivalent economic rights. Diluted net income per share includes the potential dilutive effect of other securities as if such securities were converted or exercised during the period, when the effect is dilutive. The calculations of basic and diluted net income per share are as follows:
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except per share data) 2021 2020 2021 2020
Net income - basic and diluted $ 3,098.9 $ 897.3 $ 4,214.1 $ 1,521.9
Weighted average shares - basic 105.0 109.6 105.2 109.7
Effect of dilutive securities:
Stock options 4.8 7.8 4.7 6.7
Restricted stock awards and restricted stock units 1.0 0.5 0.8 0.4
Weighted average shares - diluted 110.8 117.9 110.7 116.8
Net income per share - basic $ 29.51 $ 8.19 $ 40.06 $ 13.87
Net income per share - diluted $ 27.97 $ 7.61 $ 38.07 $ 13.03
Shares which have been excluded from diluted per share amounts because their effect would have been antidilutive include the following:
Three Months Ended
June 30, Six Months Ended
June 30,
(Shares in millions) 2021 2020 2021 2020
Stock options 5.0 0.1 5.0 3.5
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5. Marketable Securities
Marketable securities as of June 30, 2021 and December 31, 2020 consist of both available-for-sale debt securities of investment grade issuers (see below and Note 6) as well as equity securities of publicly traded companies (see Note 6).
The following tables summarize the Company's investments in available-for-sale debt securities:
(In millions) Amortized Unrealized Fair
As of June 30, 2021 Cost Basis Gains Losses Value
Corporate bonds $ 3,685.9 $ 24.3 $ ( 3.5 ) $ 3,706.7
U.S. government and government agency obligations 177.4 0.7 ( 0.1 ) 178.0
Sovereign bonds 64.9 0.7 ( 0.1 ) 65.5
Commercial paper 215.9 — — 215.9
Certificates of deposit 171.4 0.1 — 171.5
$ 4,315.5 $ 25.8 $ ( 3.7 ) $ 4,337.6
As of December 31, 2020
Corporate bonds $ 3,053.0 $ 37.5 $ ( 0.2 ) $ 3,090.3
U.S. government and government agency obligations 127.6 1.3 — 128.9
Sovereign bonds 65.2 1.1 — 66.3
Commercial paper 276.0 0.1 — 276.1
Certificates of deposit 127.4 0.1 — 127.5
$ 3,649.2 $ 40.1 $ ( 0.2 ) $ 3,689.1
The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates. The available-for-sale debt securities listed as of June 30, 2021 mature at various dates through June 2026. The fair values of available-for-sale debt securities by contractual maturity consist of the following:
June 30, December 31,
(In millions) 2021 2020
Maturities within one year $ 1,838.6 $ 1,393.3
Maturities after one year through five years 2,499.0 2,295.8
$ 4,337.6 $ 3,689.1
The following table shows the fair value of the Company's available-for-sale debt securities that have unrealized losses, aggregated by investment category and length of time that the individual securities have been in a continuous loss position.
Less than 12 Months 12 Months or Greater Total
(In millions)
As of June 30, 2021
Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss
Corporate bonds $ 1,167.0 $ ( 3.5 ) — — $ 1,167.0 $ ( 3.5 )
U.S. government and government agency obligations 111.3 ( 0.1 ) — — 111.3 ( 0.1 )
Sovereign bonds 33.4 ( 0.1 ) — — 33.4 ( 0.1 )
$ 1,311.7 $ ( 3.7 ) — — $ 1,311.7 $ ( 3.7 )
As of December 31, 2020
Corporate bonds $ 364.5 $ ( 0.2 ) — — $ 364.5 $ ( 0.2 )
For the three and six months ended June 30, 2021, realized gains and losses on sales of marketable securities were no t material. For the three and six months ended June 30, 2020, realized gains on sales of marketable securities were $ 28.0 million and $ 28.3 million, respectively, and realized losses were no t material.
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With respect to marketable securities, for the three and six months ended June 30, 2021 and 2020, amounts reclassified from Accumulated other comprehensive income into Other income (expense), net were related to realized gains and losses on sales of available-for-sale debt securities.
6. Fair Value Measurements
The table below summarizes the Company's assets which are measured at fair value on a recurring basis. The following fair value hierarchy is used to classify assets, based on inputs to valuation techniques utilized to measure fair value:
• Level 1 - Quoted prices in active markets for identical assets
• Level 2 - Significant other observable inputs, such as quoted market prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-based valuations in which significant inputs used are observable
• Level 3 - Significant other unobservable inputs
(In millions) Fair Value Measurements at Reporting Date
As of June 30, 2021 Fair Value Level 1 Level 2
Available-for-sale debt securities:
Corporate bonds $ 3,706.7 — $ 3,706.7
U.S. government and government agency obligations 178.0 — 178.0
Sovereign bonds 65.5 — 65.5
Commercial paper 215.9 — 215.9
Certificates of deposit 171.5 — 171.5
Equity securities (unrestricted) 30.4 $ 30.4 —
Equity securities (restricted) 1,370.9 1,352.9 18.0
$ 5,738.9 $ 1,383.3 $ 4,355.6
As of December 31, 2020
Available-for-sale debt securities:
Corporate bonds $ 3,090.3 — $ 3,090.3
U.S. government and government agency obligations 128.9 — 128.9
Sovereign bonds 66.3 — 66.3
Commercial paper 276.1 — 276.1
Certificates of deposit 127.5 — 127.5
Equity securities (unrestricted) 48.3 $ 48.3 —
Equity securities (restricted) 791.5 791.5 —
$ 4,528.9 $ 839.8 $ 3,689.1
The Company held certain restricted equity securities as of June 30, 2021 which are subject to transfer restrictions that expire at various dates through 2024.
During the three and six months ended June 30, 2021, we recorded $ 409.0 million and $ 552.9 million of net unrealized gains, respectively, on equity securities in Other income (expense), net. During the three and six months ended June 30, 2020, we recorded $ 228.1 million and $ 171.3 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 June 30, 2021 and December 31, 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.
The fair value of our long-term debt (see Note 8), which was determined based on Level 2 inputs, was estimated to be $ 1.868 billion and $ 1.958 billion as of June 30, 2021 and December 31, 2020, respectively.
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7. Inventories
Inventories consist of the following:
June 30, December 31,
(In millions) 2021 2020
Raw materials $ 601.5 $ 459.4
Work-in-process 741.1 904.6
Finished goods 106.3 121.7
Deferred costs 535.0 430.9
$ 1,983.9 $ 1,916.6
Deferred costs represent the costs of product manufactured and shipped to the Company's collaborators for which recognition of revenue has been deferred. For the three and six months ended June 30, 2021, Cost of goods sold included inventory write-offs and reserves totaling $ 139.9 million and $ 149.3 million, respectively. For the three and six months ended June 30, 2020, such amounts were no t material.
8. Debt
Bridge Loan Facility
As described in Note 10, 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 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. As of June 30, 2020, $ 1.5 billion remained outstanding under the Bridge Facility, and 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).
Senior Notes
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. Long-term debt in connection with our senior unsecured notes (collectively, the "Notes"), net of underwriting discounts and offering expenses, consists of the following:
June 30, December 31,
(In millions) 2021 2020
1.750 % Senior Notes due September 2030
$ 1,239.3 $ 1,238.7
2.800 % Senior Notes due September 2050
739.9 739.8
$ 1,979.2 $ 1,978.5
Interest expense related to the Notes for the three and six months ended June 30, 2021 was $ 11.1 million and $ 22.2 million, respectively.
9. Income Taxes
The Company is subject to U.S. federal, state, and foreign income taxes. The Company's effective tax rate was 17.4 % and 2.4 % for the three months ended June 30, 2021 and 2020, respectively, and 15.8 % and 4.1 % for the six months ended June 30, 2021 and 2020, respectively. The Company's effective tax rate for the three and six months ended June 30, 2021 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities. In addition, the effective tax rate for the six months ended June 30, 2021 was positively impacted by the reversal of liabilities related to uncertain tax positions. During the six months ended June 30, 2021, we reduced the amount of liabilities for uncertain tax positions related to the Company’s federal income tax returns for 2015 and 2016, and these audits are effectively settled. The Company's federal income tax returns for 2017 and 2018 are currently under audit by the Internal Revenue Service ("IRS"). The Company's effective tax rate for the three and six months ended June 30, 2020 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation, and, to a lesser extent, income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities.
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10. Stockholders' Equity
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. 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. As of December 31, 2020, the Company had repurchased the entire $ 1.0 billion it was authorized to repurchase under the program.
In January 2021, our board of directors authorized a new share repurchase program to repurchase up to $ 1.5 billion of our Common Stock. The share repurchase program was approved under terms substantially similar to the November 2019 share repurchase program described above. Repurchases may be made from time to time at management’s discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors. The program has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases in the future. As of June 30, 2021, $ 887.9 million remained available for share repurchases under the program.
The table below summarizes the shares of our Common Stock we repurchased under the programs during the three and six months ended June 30, 2021 and 2020 and the cost of the shares received, which were recorded as Treasury Stock.
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2021 2020 2021 2020
Number of shares repurchased 0.6 — 1.3 0.7
Total cost of shares received $ 288.6 — $ 612.1 $ 272.8
Sanofi Funding of Certain Development Costs
In 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"). Pursuant to the Letter Agreement, we agreed to allow Sanofi to satisfy its funding obligations with respect to Dupilumab/Itepekimab Eligible Investments, as well as Libtayo development costs, for quarterly periods ending on September 30, 2020 by selling our Common Stock owned by Sanofi. During the three and six months ended June 30, 2020, Sanofi elected to sell, and we elected to purchase (by issuing a credit towards the amount owed by Sanofi), 34,050 and 77,677 shares of our Common Stock to satisfy Sanofi's funding obligation related to Libtayo development costs, respectively, and we recorded the cost of the shares received, or $ 20.3 million and $ 41.7 million, respectively, as Treasury Stock. During the three and six months ended June 30, 2020, Sanofi elected to sell, and we elected to purchase (in cash), 86,184 and 171,471 shares of our Common Stock in connection with Sanofi's funding obligation for Dupilumab/Itepekimab Eligible Investments, respectively, and recorded the cost of the shares received, or $ 51.5 million and $ 93.3 million, respectively, as Treasury Stock.
Additional Stock Purchased from Sanofi
In May 2020, a secondary offering of 13,014,646 shares of our Common Stock (the "Secondary Offering") held by Sanofi was completed. In connection with the Secondary Offering, we also purchased 9,806,805 shares directly from Sanofi for an aggregate purchase amount of $ 5.0 billion (the "Stock Purchase"). 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 Libtayo development costs and/or Dupilumab/Itepekimab Eligible Investments as described above).
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11. Statement of Cash Flows
The following provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheet to the total of the same such amounts shown in the Condensed Consolidated Statement of Cash Flows:
June 30,
(In millions) 2021 2020
Cash and cash equivalents $ 2,072.2 $ 1,992.2
Restricted cash included in Other noncurrent assets
12.5 12.5
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statement of Cash Flows
$ 2,084.7 $ 2,004.7
Restricted cash consists of amounts held by financial institutions pursuant to contractual arrangements.
Supplemental disclosure of non-cash investing and financing activities
The following amounts were included in accounts payable, accrued expenses, and other liabilities:
June 30, December 31, June 30, December 31,
(In millions) 2021 2020 2020 2019
Accrued capital expenditures $ 93.4 $ 83.6 $ 87.4 $ 133.7
As described in Note 10, during the three months ended June 30, 2020, 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.
12. Legal Matters
From time to time, the Company is a party to legal proceedings in the course of the Company's business. Costs associated with the Company's involvement in legal proceedings are expensed as incurred. The outcome of any such proceedings, regardless of the merits, is inherently uncertain. The Company recognizes accruals for loss contingencies associated with such proceedings when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. As of June 30, 2021 and December 31, 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.
Proceedings Relating to Praluent (alirocumab) Injection
As described in greater detail below, the Company is currently a party to patent infringement actions initiated by Amgen Inc. (and/or its affiliated entities) against the Company and/or Sanofi (and/or the Company's and Sanofi's respective affiliated entities) in a number of jurisdictions relating to Praluent. See Note 3 for a description of the Company's and Sanofi's arrangement regarding the costs resulting from or associated with such actions.
United States
In the United States, Amgen has asserted claims of U.S. Patent Nos. 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. Amgen also seeks a judgment of patent infringement of the asserted patents, monetary damages (together with interest), costs and expenses of the lawsuits, and attorneys' fees. As described in greater detail under "Second Jury Trial and Appeal" below, on February 11, 2021, the Federal Circuit (as defined below) affirmed the lower court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement.
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First Jury Trial and Appeal. The first jury trial in this litigation (the "First Trial") was held in the United States District Court for the District of Delaware (the "District Court") from March 8 to March 16, 2016. During the course of the First Trial, the District Court ruled as a matter of law in favor of Amgen that the asserted patent claims were not obvious, and in favor of the Company and the Sanofi defendants that there was no willful infringement of the asserted patent claims by the Company or the Sanofi defendants. On March 16, 2016, the jury returned a verdict in favor of Amgen in the First Trial, finding that the asserted claims of the '165 and '741 Patents were not invalid based on either a lack of written description or a lack of enablement. On October 5, 2017, the United States Court of Appeals for the Federal Circuit (the "Federal Circuit") reversed in part the District Court's decision and remanded for a new trial on the issues of written description and enablement. In addition, it affirmed the District Court's ruling that Amgen's patents were not obvious.
Second Jury Trial and Appeal. On January 3, 2019, the District Court held oral argument in the remanded proceedings on the Company and the Sanofi defendants' motion for judgment on the pleadings regarding Amgen's willful infringement claim. On January 18, 2019, the District Court entered an order (i) denying the Company and the Sanofi defendants' motion for summary judgment on validity, (ii) denying Amgen's motion for partial summary judgment on estoppel, and (iii) granting the Company and the Sanofi defendants' cross-motion for summary judgment on estoppel. On February 8, 2019, the District Court granted the Company and the Sanofi defendants' motion for judgment on the pleadings, thereby dismissing Amgen's claim of willful infringement. The second jury trial in this litigation (the "Second Trial") was held before the District Court in February 2019 to determine the validity of Amgen's asserted patent claims. On February 25, 2019, the jury returned a verdict in the Second Trial generally in favor of Amgen, finding that two claims of the '165 Patent and one claim of the '741 Patent were not invalid. The jury also found that two claims of the '165 Patent were invalid for lack of adequate written description while rejecting the lack of enablement challenges to those two claims. On August 28, 2019, the District Court ruled as a matter of law that Amgen's asserted patent claims are invalid based on lack of enablement. The District Court also conditionally denied the Company and the Sanofi defendants' motion for a new trial. On October 23, 2019, Amgen filed a notice of appeal of the District Court's decision with the Federal Circuit. An oral hearing before the Federal Circuit was held on December 9, 2020. On February 11, 2021, the Federal Circuit affirmed the District Court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement. On April 14, 2021, Amgen filed a petition for a rehearing en banc, which was denied on June 21, 2021.
Injunctive Relief Proceedings. On March 18, 2019, Amgen filed a renewed motion for a permanent injunction to prohibit the Company and the Sanofi defendants from Commercializing Praluent in the United States (a "Permanent Injunction"), and an oral hearing on this motion was held in June 2019. Previously, the Federal Circuit stayed and then vacated a Permanent Injunction granted by the District Court in connection with the First Trial. On August 28, 2019, the District Court dismissed as moot Amgen's renewed motion for a Permanent Injunction.
Europe
Amgen has asserted European Patent No. 2,215,124 (the "'124 Patent"), which pertains to PCSK9 monoclonal antibodies, in the countries in Europe discussed below. 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"). This decision has impacted or will impact each of the infringement proceedings based on the '124 Patent discussed below.
EPO Proceedings. 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. 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. 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. The Company and Sanofi filed notices of appeal to the TBA on November 30, 2018. 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 relevant to Praluent were invalid based on a lack of inventive step.
United Kingdom. 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. The lawsuit also seeks a permanent injunction, damages, an accounting of profits, and costs and interest. On February 8, 2017, the court temporarily stayed this litigation on terms mutually agreed by the parties. 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.
Germany. 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,
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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. 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). 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. 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"). Amgen subsequently enforced the injunction and, as a result, commercialization of Praluent in Germany was discontinued. On July 12, 2019, the Company and Sanofi appealed the July 11 Decision to the Higher Regional Court of Düsseldorf (the "Higher Regional Court"). 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. On November 3, 2020, Amgen filed a motion withdrawing this lawsuit without prejudice. 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.
France. 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). 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; an appointment of an expert for the assessment of damages; disclosure of technical (including supply-chain) and accounting information to the expert and the court; provisional damages of € 10.0 million (which would be awarded on an interim basis pending final determination); reimbursement of costs; publication of the ruling in three newspapers; and provisional enforcement of the decision to be issued, which would ensure enforcement of the decision (including any provisional damages) pending appeal. Amgen is not seeking a preliminary injunction in this proceeding at this time. 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. On June 22, 2021, the lawsuit was dismissed.
Other. In December 2019, Amgen also filed lawsuits in the Netherlands, Italy, and Spain for infringement of the relevant designation of the '124 Patent in each such jurisdiction. The Company was not named as a defendant in any of these actions. Each of these lawsuits was dismissed in February 2021.
Japan
As previously reported, on March 31, 2020, Amgen filed a lawsuit in the Tokyo District Court against Sanofi K.K. seeking damages incurred by Amgen as a result of the earlier finding of infringement of Amgen's Japanese Patent Nos. 5,906,333 and 5,705,288 by the Tokyo District Court Civil Division. The Company has not been named as a defendant in this damages action.
Proceedings Relating to Dupixent (dupilumab) Injection
United States
On March 20, 2017, the Company, Sanofi-Aventis U.S. 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. Patent No. 8,679,487 (the "'487 Patent") owned by Immunex Corporation relating to antibodies that bind the human interleukin-4 receptor. On May 1, 2017, the Company and the other plaintiffs filed a notice of voluntary dismissal of this action without prejudice.
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On March 23, 2017, the Company, Sanofi-Aventis U.S. LLC, and Genzyme Corporation initiated an inter partes review ("IPR") in the United States Patent and Trademark Office ("USPTO") seeking a declaration of invalidity of the '487 Patent. 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"). 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. 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. Oral hearings on the Additional IPR Petitions before the PTAB were held on November 14, 2018. 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. 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. 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. On March 11, 2021, Immunex filed a petition for writ of certiorari with the United States Supreme Court, which was denied on June 21, 2021. The '487 Patent expired in May 2020 following Immunex's filing of a terminal disclaimer with the USPTO.
On April 5, 2017, Immunex Corporation filed a lawsuit against the Company, Sanofi, Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Aventisub LLC in the United States District Court for the Central District of California seeking a judgment of patent infringement of the '487 Patent and a declaratory judgment of infringement of the '487 Patent, in each case by the Company's and the other defendants' Commercializing of Dupixent; monetary damages (together with interest); an order of willful infringement of the '487 Patent, which would allow the court in its discretion to award damages up to three times the amount assessed; costs and expenses of the lawsuit; and attorneys' fees. Immunex is not seeking an injunction in this proceeding at this time. On June 21, 2017, the court denied a motion to dismiss Immunex's complaint previously filed by the Company and the Sanofi parties. 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. 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. On August 24, 2018, the court issued an order denying this motion and construed the disputed claim terms as proposed by Amgen. 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. On August 3, 2021, the court granted a motion to dismiss the lawsuit, dismissing all of Immunex's claims with prejudice.
Europe
On September 30, 2016, Sanofi initiated a revocation proceeding in the United Kingdom to invalidate the U.K. counterpart of European Patent No. 2,292,665 (the "'665 Patent"), another patent owned by Immunex relating to antibodies that bind the human interleukin-4 receptor. At the joint request of the parties to the revocation proceeding, the U.K. Patents Court ordered on January 30, 2017 that the revocation action be stayed pending the final determination of the currently pending EPO opposition proceedings initiated by the Company and Sanofi in relation to the '665 Patent. The oral hearing before the EPO on the oppositions occurred on November 20, 2017, at which the claims of the '665 Patent were found invalid and the patent was revoked. A final written decision of revocation of the '665 Patent was issued by the EPO on January 4, 2018. Immunex filed a notice of appeal of the EPO's decision on January 31, 2018, and an oral hearing before the TBA has been scheduled for March 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. 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. 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 2022. The original patent term of the Immunex patents expired in May 2021.
Proceedings Relating to EYLEA (aflibercept) Injection
On January 7, 2021, Chengdu Kanghong Pharmaceutical Group Co., Ltd. ("Chengdu Kanghong") filed an IPR petition in the USPTO against the Company' s U.S. Patent No. 10,464,992 (the "'992 Patent") and a post-grant review petition against the Company's U.S. Patent No. 10,828,345 (the "'345 Patent") seeking declarations of invalidity of the '992 Patent and '345 Patent. On June 23, 2021, Chengdu Kanghong filed motions to dismiss each of these petitions and terminate the respective proceedings, which were granted by the USPTO on June 25, 2021.
On February 11, 2020, anonymous parties filed two requests for ex parte reexamination of the Company's U.S. Patent No. 10,406,226 and the '992 Patent, and the USPTO has granted both requests to initiate reexamination proceedings.
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On May 5, 2021, Mylan Pharmaceuticals Inc. filed IPR petitions in the USPTO against the Company's U.S. Patent Nos. 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.
Proceedings Relating to EYLEA (aflibercept) Injection Pre-filled Syringe
On June 19, 2020, Novartis Pharma AG, Novartis Pharmaceuticals Corporation, and Novartis Technology LLC (collectively, "Novartis") filed a complaint with the U.S. International Trade Commission (the "ITC") pursuant to Section 337 of the Tariff Act of 1930 requesting that the ITC institute an investigation relating to the importation into the United States and/or sale within the United States after importation of EYLEA pre-filled syringes ("PFS") and/or components thereof which allegedly infringe Novartis’s U.S. Patent No. 9,220,631 (the "'631 Patent"). Novartis also requested a permanent limited exclusion order forbidding entry into the United States of EYLEA PFS or components thereof; a permanent cease-and-desist order from the importation, sale, offer for sale, advertising, packaging, or solicitation of any sale by the Company of EYLEA PFS or components thereof; and a bond should the Company continue to import EYLEA PFS (if found to infringe) during, if applicable, any 60-day Presidential review period ( i.e. , the period when the President of the United States (or his designee) can disapprove any ITC decision to issue an exclusion order or cease-and-desist order). The ITC instituted the investigation on July 22, 2020 and a trial was scheduled for April 19–23, 2021. 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. On April 8, 2021, Novartis moved to terminate the ITC investigation in its entirety based on its withdrawal of the complaint; and, on May 3, 2021, the ITC terminated the investigation.
On June 19, 2020, Novartis also filed a patent infringement lawsuit 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. Novartis also seeks a judgment of patent infringement of the '631 Patent, monetary damages (together with interest), an order of willful infringement of the '631 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuits, and attorneys' fees. On July 30, 2020, the court granted the Company's motion to stay these proceedings until a determination in the ITC proceedings discussed above, including any appeals therefrom, becomes final. On April 8, 2021, Novartis requested that the stay of this lawsuit be lifted. On June 11, 2021, the court lifted the stay; and, on July 11, 2021, the Company filed a motion to dismiss the claim of willful infringement.
On July 16, 2020, the Company initiated two IPR petitions in the USPTO seeking a declaration of invalidity of the '631 Patent on two separate grounds. On January 15, 2021, the USPTO declined to institute an IPR proceeding on procedural grounds in light of the pending ITC investigation discussed above; the other IPR petition has been withdrawn. Following Novartis's motion to terminate the ITC investigation discussed above, on April 16, 2021 the Company filed a new IPR petition seeking a declaration of invalidity of the '631 Patent based on the same grounds that were the basis for the OUII staff attorney's determination discussed above.
On July 17, 2020, the Company filed an antitrust lawsuit against Novartis and Vetter Pharma International Gmbh ("Vetter") in the United States District Court for the Southern District of New York seeking a declaration that the '631 Patent is unenforceable and a judgment that the defendants' conduct violates Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act"). The Company is also seeking injunctive relief and treble damages. On September 4, 2020, Novartis filed, and Vetter moved to join, a motion to dismiss the complaint, to transfer the lawsuit to the Northern District of New York, or to stay the suit; and on October 19, 2020, Novartis filed, and Vetter moved to join, a second motion to dismiss the complaint on different grounds. On January 25, 2021, the Company filed an amended complaint seeking a judgment that Novartis's conduct violates Section 2 of the Sherman Antitrust Act based on additional grounds, as well as a judgment of tortious interference with contract. On February 22, 2021, Novartis filed, and Vetter moved to join, a motion to dismiss the amended complaint.
Proceedings Related to "Most Favored Nation" Interim Final Rule
On December 11, 2020, the Company filed a lawsuit in the United States District Court for the Southern District of New York against the U.S. Department of Health and Human Services, the Secretary of HHS, the Centers for Medicare & Medicaid Services ("CMS"), and the Administrator of CMS seeking declaratory and injunctive relief related to the interim final rule with comment period entitled "Most Favored Nation (MFN) Model" issued on November 20, 2020 by HHS, acting through CMS. On the same day, the Company filed a motion for a preliminary injunction and temporary restraining order, seeking to prevent implementation of the MFN Rule. On December 22, 2020, the court heard oral argument on the Company's motion for a preliminary injunction and temporary restraining order. On December 31, 2020, the court granted the Company's motion and issued a preliminary injunction. On February 2, 2021, the government stated to the court that the Solicitor General had
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determined not to appeal the preliminary injunction. On February 10, 2021, the court entered a 90-day stay of the litigation. On May 11, 2021, the court entered an additional 90-day stay of the litigation.
Proceedings Relating to fasinumab
On May 21, 2020, the Company and Teva Pharmaceutical Industries Limited ("Teva") filed a lawsuit against Rinat Neurosciences Corp. ("Rinat"), a wholly owned subsidiary of Pfizer Inc., in the English High Court of Justice in London, seeking invalidation and revocation of Rinat's European Patent No. 2,270,048 (the "'048 Patent"), European Patent No. 1,871,416 (the "'416 Patent"), and European Patent No. 2,305,711 (the "'711 Patent"), each of which pertains to the use of NGF monoclonal antibodies to treat certain symptoms in patients suffering from osteoarthritis. On July 21, 2020, Rinat filed its defense and counterclaim seeking a declaration of infringement of the '048 Patent by fasinumab. The counterclaim also seeks a permanent injunction, damages, an accounting of profits, and costs and interest. On December 15, 2020, Rinat filed an amended defense and counterclaim seeking a declaration of infringement of the '711 Patent by fasinumab. On May 5, 2021, the court stayed this litigation on terms mutually agreed by the parties.
The '048 Patent is subject to opposition proceedings in the EPO, which were initiated by the Company on August 10, 2016 and two other opponents on August 11, 2016. On January 3, 2018, the Opposition Division of the EPO issued a preliminary, non-binding opinion regarding the validity of the '048 Patent, indicating that it considered the granted patent to be invalid. An oral hearing on the oppositions against the '048 Patent was held on November 29–30, 2018, at which the Opposition Division upheld the validity of the '048 Patent's claims in amended form. The Company filed a notice of appeal to the TBA of the EPO on March 7, 2019. On October 21, 2020, Teva filed a notice of intervention with the TBA to take part in the appeal proceedings as an intervener. An oral hearing before the TBA has been scheduled for April 5–6, 2022.
The '711 Patent is also subject to opposition proceedings in the EPO, which were initiated by the Company on May 1, 2018. On January 31, 2019, the Opposition Division of the EPO issued a preliminary, non-binding opinion regarding the validity of the '711 Patent, indicating that it considered the granted patent to be invalid. An oral hearing on the opposition against the '711 Patent was held on December 3, 2019, at which the Opposition Division upheld the validity of the '711 Patent's claims in amended form. The Company filed a notice of appeal to the TBA on December 20, 2019. On January 29, 2021, Teva filed a notice of intervention with the TBA to take part in the appeal proceedings as an intervener. An oral hearing before the TBA was held on July 29, 2021, at which the '711 Patent was revoked in its entirety.
Proceedings Relating to REGEN-COV (casirivimab and imdevimab)
On October 5, 2020, Allele Biotechnology and Pharmaceuticals, Inc. ("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. Patent No. 10,221,221 (the "'221 Patent"). Allele seeks a judgment of patent infringement of the '221 Patent, an award of monetary damages (together with interest), an order of willful infringement of the '221 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuit, and attorneys' fees. On July 16, 2021, the Company filed a motion to dismiss the complaint.
Department of Justice Matters
In January 2017, the Company received a subpoena from the U.S. Attorney's Office for the District of Massachusetts requesting documents relating to its support of 501(c)(3) organizations that provide financial assistance to patients; documents concerning its provision of financial assistance to patients with respect to products sold or developed by Regeneron (including EYLEA, Praluent, ARCALYST, and ZALTRAP ® ); and certain other related documents and communications. On June 24, 2020, the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in the U.S. District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute, and asserting causes of action under the federal False Claims Act and state law. On August 24, 2020, the Company filed a motion to dismiss the complaint in its entirety. On December 4, 2020, the court denied the motion to dismiss.
In September 2019, the Company and Regeneron Healthcare Solutions, Inc., a wholly-owned subsidiary of the Company, each received a civil investigative demand ("CID") from the U.S. Department of Justice pursuant to the federal False Claims Act relating to remuneration paid to physicians in the form of consulting fees, advisory boards, speaker fees, and payment or reimbursement for travel and entertainment allegedly in violation of the federal Anti-Kickback Statute. The CIDs relate to EYLEA, Praluent, Dupixent, ZALTRAP, ARCALYST, and Kevzara and cover the period from January 2015 to the present. On June 3, 2021, the United States District Court for the Central District of California unsealed a qui tam complaint filed against the Company, Regeneron Healthcare Solutions, Inc., and Sanofi-Aventis U.S. LLC by two qui tam plaintiffs (known as relators) purportedly on behalf the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law. Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case.
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In June 2021, the Company received a CID from the U.S. Department of Justice pursuant to the federal False Claims Act. The CID states that the investigation concerns allegations that the Company (i) violated the False Claims Act by paying kickbacks to distributors and ophthalmology practices to induce purchase of EYLEA, including through discounts, rebates, credit card fees, free units of EYLEA, and inventory management systems; and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to CMS. The CID covers the period from January 2011 through June 2021. The Company is cooperating with this investigation.
Proceedings Initiated by UnitedHealthcare
On December 17, 2020, UnitedHealthcare Insurance Company and United Healthcare Services, Inc. (collectively, "UHC") filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging UHC has been damaged by the conduct alleged in the civil complaint filed by the U.S. Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above. UHC alleges causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act (the "RICO Act") and seeks monetary damages and equitable relief. On March 1, 2021, the Company filed a motion to dismiss the complaint in its entirety. On March 25, 2021, UHC filed an amended complaint; and, on April 22, 2021, the Company filed a motion to dismiss this amended complaint in its entirety.
Proceedings Initiated by Humana
On July 22, 2021, Humana Inc. ("Humana") filed a lawsuit against the Company in the United States District Court for the Southern District of New York alleging Humana has been damaged by the conduct alleged in the civil complaint filed by the U.S. Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above. Humana alleges causes of action under state law and the RICO Act and seeks monetary damages and equitable relief.
Shareholder Demand
On or about September 30, 2020, the Company's board of directors received a demand letter from a purported shareholder of the Company. The demand alleges that Regeneron and its shareholders have been damaged by the conduct alleged in the civil complaint filed by the U.S. Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above. The demand letter requests that the Company's board of directors investigate alleged breaches of fiduciary duty by its officers and directors and other alleged violations of law and corporate governance practices and procedures; bring legal action against the persons responsible for causing the alleged damages; and implement and maintain an effective system of internal controls, compliance mechanisms, and corporate governance practices and procedures. The Company's board of directors, working with outside counsel, investigated and evaluated the allegations in the demand letter and has concluded that pursuing the claims alleged in the demand would not be in the Company's best interests at this time.
Proceedings Relating to Shareholder Derivative Complaint
On June 29, 2021, an alleged shareholder filed a shareholder derivative complaint in the New York Supreme Court, naming the current and certain former members of the Company's board of directors and certain current and former executive officers of the Company as defendants and Regeneron as a nominal defendant. The complaint asserts that the individual defendants breached their fiduciary duties in relation to the allegations in the civil complaint filed by the U.S. Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above. The complaint seeks an award of damages allegedly sustained by the Company; an order requiring Regeneron to take all necessary actions to reform and improve its corporate governance and internal procedures; disgorgement from the individual defendants of all profits and benefits obtained by them resulting from their sales of Regeneron stock; and costs and disbursements of the action, including attorneys' fees. On July 28, 2021, the defendants filed a notice of removal, removing the case from the New York Supreme Court to the U.S. District Court for the Southern District of New York.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.