Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In millions, except per share data)
June 30, December 31,
2022 2021
ASSETS
Current assets:
Cash and cash equivalents $ 3,395.1 $ 2,885.6
Marketable securities 4,171.3 2,809.1
Accounts receivable, net 5,161.4 6,036.5
Inventories 2,218.5 1,951.3
Prepaid expenses and other current assets 583.6 332.4
Total current assets 15,529.9 14,014.9
Marketable securities 6,415.9 6,838.0
Property, plant, and equipment, net 3,637.7 3,482.2
Deferred tax assets 1,352.4 876.9
Other noncurrent assets 269.9 222.8
Total assets $ 27,205.8 $ 25,434.8
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 534.2 $ 564.0
Accrued expenses and other current liabilities 1,933.4 2,206.8
Finance lease liabilities — 719.7
Deferred revenue 566.3 442.0
Total current liabilities 3,033.9 3,932.5
Long-term debt 1,980.7 1,980.0
Finance lease liabilities 720.0 —
Deferred revenue 58.7 73.3
Other noncurrent liabilities 724.7 680.2
Total liabilities 6,518.0 6,666.0
Stockholders' equity:
Preferred Stock, par value $ .01 per share; 30.0 shares authorized; issued and outstanding - no ne
— —
Class A Stock, convertible, par value $ .001 per share; 40.0 shares authorized; shares issued and outstanding - 1.8 in 2022 and 2021
— —
Common Stock, par value $ .001 per share; 320.0 shares authorized; shares issued - 128.3 in 2022 and 126.2 in 2021
0.1 0.1
Additional paid-in capital 9,120.2 8,087.5
Retained earnings 20,793.9 18,968.3
Accumulated other comprehensive loss ( 223.8 ) ( 26.2 )
Treasury Stock, at cost; 20.6 shares in 2022 and 19.4 shares in 2021
( 9,002.6 ) ( 8,260.9 )
Total stockholders' equity 20,687.8 18,768.8
Total liabilities and stockholders' equity $ 27,205.8 $ 25,434.8
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,
2022 2021 2022 2021
Statements of Operations
Revenues:
Net product sales $ 1,754.4 $ 4,137.8 $ 3,393.0 $ 5,862.1
Collaboration revenue 1,043.6 954.7 2,276.1 1,709.1
Other revenue 59.2 46.0 153.2 96.0
2,857.2 5,138.5 5,822.3 7,667.2
Expenses:
Research and development 794.3 714.2 1,638.1 1,457.1
Acquired in-process research and development 197.0 — 225.1 —
Selling, general, and administrative 476.3 414.7 926.3 820.3
Cost of goods sold 149.2 539.4 356.5 722.6
Cost of collaboration and contract manufacturing 147.9 154.3 345.5 279.1
Other operating (income) expense, net ( 17.4 ) ( 31.3 ) ( 37.6 ) ( 71.8 )
1,747.3 1,791.3 3,453.9 3,207.3
Income from operations 1,109.9 3,347.2 2,368.4 4,459.9
Other income (expense):
Other (expense) income, net ( 133.6 ) 420.0 ( 317.4 ) 574.9
Interest expense ( 13.1 ) ( 14.4 ) ( 26.7 ) ( 29.0 )
( 146.7 ) 405.6 ( 344.1 ) 545.9
Income before income taxes 963.2 3,752.8 2,024.3 5,005.8
Income tax expense 111.1 653.9 198.7 791.7
Net income $ 852.1 $ 3,098.9 $ 1,825.6 $ 4,214.1
Net income per share - basic $ 7.90 $ 29.51 $ 17.01 $ 40.06
Net income per share - diluted $ 7.47 $ 27.97 $ 16.07 $ 38.07
Weighted average shares outstanding - basic 107.9 105.0 107.3 105.2
Weighted average shares outstanding - diluted 114.0 110.8 113.6 110.7
Statements of Comprehensive Income
Net income $ 852.1 $ 3,098.9 $ 1,825.6 $ 4,214.1
Other comprehensive income (loss), net of tax:
Unrealized loss on debt securities ( 53.7 ) ( 0.8 ) ( 198.6 ) ( 14.1 )
Unrealized gain on cash flow hedges — 0.3 1.0 0.5
Comprehensive income $ 798.4 $ 3,098.4 $ 1,628.0 $ 4,200.5
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, 2021 1.8 $ — 126.2 $ 0.1 $ 8,087.5 $ 18,968.3 $ ( 26.2 ) ( 19.4 ) $ ( 8,260.9 ) $ 18,768.8
Issuance of Common Stock for equity awards granted under long-term incentive plans
— — 1.6 — 593.7 — — — — 593.7
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations
— — ( 0.2 ) — ( 105.8 ) — — — — ( 105.8 )
Issuance/distribution of Common Stock for 401(k) Savings Plan
— — — — 12.8 — — — 1.7 14.5
Repurchases of Common Stock
— — — — — — — ( 0.5 ) ( 352.0 ) ( 352.0 )
Stock-based compensation charges — — — — 165.9 — — — — 165.9
Net income — — — — — 973.5 — — — 973.5
Other comprehensive loss, net of tax — — — — — — ( 143.9 ) — — ( 143.9 )
Balance, March 31, 2022 1.8 — 127.6 0.1 8,754.1 19,941.8 ( 170.1 ) ( 19.9 ) ( 8,611.2 ) 19,914.7
Issuance of Common Stock for equity awards granted under long-term incentive plans — — 0.8 — 228.0 — — — — 228.0
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations — — ( 0.1 ) — ( 41.9 ) — — — — ( 41.9 )
Issuance/distribution of Common Stock for 401(k) Savings Plan — — — — 14.0 — — — 2.2 16.2
Repurchases of Common Stock — — — — — — — ( 0.7 ) ( 393.6 ) ( 393.6 )
Stock-based compensation charges — — — — 166.0 — — — — 166.0
Net income — — — — — 852.1 — — — 852.1
Other comprehensive loss, net of tax — — — — — — ( 53.7 ) — — ( 53.7 )
Balance, June 30, 2022 1.8 $ — 128.3 $ 0.1 $ 9,120.2 $ 20,793.9 $ ( 223.8 ) ( 20.6 ) $ ( 9,002.6 ) $ 20,687.8
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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, 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
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,
2022 2021
Cash flows from operating activities:
Net income $ 1,825.6 $ 4,214.1
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 148.7 138.5
Stock-based compensation expense 326.7 276.4
Losses (gains) on marketable and other securities, net 370.9 ( 553.9 )
Other non-cash items, net 138.3 192.6
Deferred taxes ( 381.0 ) 51.8
Acquired in-process research and development in connection with asset acquisition 195.0 —
Changes in assets and liabilities:
Decrease (increase) in accounts receivable 875.1 ( 2,883.9 )
Increase in inventories ( 328.7 ) ( 221.5 )
Increase in prepaid expenses and other assets ( 288.5 ) ( 277.8 )
Increase (decrease) in deferred revenue 109.7 ( 64.8 )
(Decrease) increase in accounts payable, accrued expenses, and other liabilities ( 325.7 ) 423.7
Total adjustments 840.5 ( 2,918.9 )
Net cash provided by operating activities 2,666.1 1,295.2
Cash flows from investing activities:
Purchases of marketable and other securities ( 3,774.9 ) ( 1,886.5 )
Sales or maturities of marketable and other securities 2,181.4 1,217.1
Capital expenditures ( 295.4 ) ( 263.8 )
Asset acquisition, net of cash acquired ( 230.3 ) —
Net cash used in investing activities ( 2,119.2 ) ( 933.2 )
Cash flows from financing activities:
Proceeds from issuance of Common Stock 828.4 308.2
Payments in connection with Common Stock tendered for employee tax obligations ( 147.7 ) ( 180.7 )
Repurchases of Common Stock ( 717.1 ) ( 612.1 )
Net cash used in financing activities ( 36.4 ) ( 484.6 )
Net increase (decrease) in cash, cash equivalents, and restricted cash 510.5 ( 122.6 )
Cash, cash equivalents, and restricted cash at beginning of period 2,898.1 2,207.3
Cash, cash equivalents, and restricted cash at end of period $ 3,408.6 $ 2,084.7
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, 2021 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, 2021.
Beginning with the first quarter of 2022, the Company added a new line item, Acquired in-process research and development, to its Condensed Consolidated Statements of Operations and Comprehensive Income. This line item includes in-process research and development acquired in connection with asset acquisitions as well as up-front/opt-in payments related to license and collaboration agreements. Amounts recorded in this line item for the three and six months ended June 30, 2022 would have historically been recorded to Research and development expenses. No such amounts were recorded for the three and six months ended June 30, 2021.
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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
2022 2021 2022 2021
EYLEA ®
$ 1,621.2 $ 1,424.7 $ 3,138.8 $ 2,771.7
Libtayo ®*
90.9 78.0 169.8 147.1
Praluent ®
31.2 41.9 64.8 85.2
REGEN-COV ®**
— 2,591.2 — 2,853.4
Evkeeza ®
11.1 2.0 19.6 2.5
ARCALYST ®***
— — — 2.2
$ 1,754.4 $ 4,137.8 $ 3,393.0 $ 5,862.1
** Net product sales of REGEN-COV in the United States relate to product sold in connection with our agreements with the U.S. government. 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.
* Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States. Effective July 1, 2022, the Company will record global net product sales of Libtayo. See Note 3 for further details.
As of June 30, 2022 and December 31, 2021, the Company had $ 3.888 billion and $ 5.059 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, 2022 and 2021. 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,
2022 2021 2022 2021
Besse Medical, a subsidiary of AmerisourceBergen Corporation
57 % 22 % 56 % 30 %
McKesson Corporation 28 % 14 % 29 % 19 %
U.S. government — % 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) 2022 2021 2022 2021
Antibody:
Regeneron's share of profits in connection with commercialization of antibodies Collaboration revenue $ 496.6 $ 327.6 $ 911.9 $ 588.2
Sales-based milestone earned Collaboration revenue $ — $ — $ 50.0 $ —
Reimbursement for manufacturing of commercial supplies Collaboration revenue $ 145.5 $ 110.9 $ 306.3 $ 216.5
Other Collaboration revenue $ 28.9 $ — $ 28.9 $ —
Reimbursement of research and development expenses Reduction of Research and development expense $ 52.7 $ 46.5 $ 89.2 $ 77.1
Regeneron's obligation for its share of Sanofi research and development expenses Research and development expense $ ( 15.6 ) $ ( 10.6 ) $ ( 25.3 ) $ ( 22.5 )
Reimbursement of commercialization-related expenses Reduction of Selling, general, and administrative expense $ 110.8 $ 78.3 $ 202.5 $ 137.9
Immuno-oncology:
Regeneron's share of profits (losses) in connection with commercialization of Libtayo outside the United States Collaboration revenue $ 3.9 $ ( 3.5 ) $ 6.7 $ ( 9.6 )
Reimbursement for manufacturing of ex-U.S. commercial supplies Collaboration revenue $ 2.6 $ 2.7 $ 4.6 $ 7.4
Reimbursement of research and development expenses Reduction of Research and development expense $ 21.2 $ 22.5 $ 42.7 $ 44.4
Reimbursement of commercialization-related expenses Reduction of Selling, general, and administrative expense $ 22.4 $ 20.7 $ 41.4 $ 39.2
Regeneron's obligation for its share of Sanofi commercial expenses Selling, general, and administrative expense $ ( 10.7 ) $ ( 10.9 ) $ ( 19.9 ) $ ( 18.6 )
Regeneron's obligation for Sanofi's share of Libtayo U.S. gross profits Cost of goods sold $ ( 37.8 ) $ ( 34.4 ) $ ( 70.1 ) $ ( 64.8 )
Amounts recognized in connection with up-front payments received Other operating income $ 17.0 $ 20.7 $ 35.1 $ 43.6
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, Sanofi is generally responsible for funding 80 % to 100 % of agreed-upon development costs. We are obligated to reimburse Sanofi for 30 % to 50 % of worldwide development expenses that were funded by Sanofi based on our share of collaboration profits from commercialization of collaboration products. Under the terms of the Antibody License and Collaboration Agreement, we were 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. On July 1, 2022, an amendment to the Antibody License and Collaboration Agreement became effective, pursuant to which the percentage of Regeneron’s share of profits used to reimburse Sanofi for such development costs increased from 10 % to 20 %.
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
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from Sanofi. During the three months ended March 31, 2022, the Company earned a $ 50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $ 2.0 billion on a rolling twelve-month basis. We are entitled to receive up to an aggregate of $ 100.0 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 $ 2.5 billion on a rolling twelve-month basis.
The following table summarizes contract balances in connection with the Company's Antibody Collaboration with Sanofi:
June 30, December 31,
(In millions) 2022 2021
Accounts receivable, net $ 751.5 $ 504.8
Deferred revenue
$ 457.5 $ 368.7
Immuno-oncology
The Company has been party to a collaboration with Sanofi for antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration"). Under the terms of the Immuno-oncology License and Collaboration Agreement, the parties were co-developing and co-commercializing Libtayo. The parties shared equally, on an ongoing basis, development and commercialization expenses for Libtayo. The Company had principal control over the development of Libtayo and led commercialization activities in the United States (see Note 2 for related product sales information), while Sanofi led commercialization activities outside of the United States. The parties shared equally in profits and losses in connection with the commercialization of Libtayo.
Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA"). Consequently, in July 2022, the Company made a $ 900.0 million up-front payment to Sanofi, and Sanofi is eligible to receive a $ 100.0 million regulatory milestone and up to an aggregate of $ 100.0 million in sales-based milestones upon achieving certain amounts of worldwide net product sales of Libtayo through 2023. The Company will also pay Sanofi an 11 % royalty on net product sales of Libtayo through March 31, 2034. Amounts paid to Sanofi in connection with obtaining the worldwide rights to Libtayo, including the up-front payment and any contingent consideration, will be recorded as an intangible asset.
The Company was obligated to reimburse Sanofi for half of the development costs it funded that were attributable to clinical development of antibody product candidates under the Amended and Restated Immuno-oncology Discovery and Development Agreement from our share of profits from commercialized IO Collaboration products. Under the A&R IO LCA, the amount of development costs incurred under the IO Collaboration for which we are obligated to reimburse Sanofi is $ 35.0 million, and the Company will reimburse Sanofi for such development costs by paying Sanofi a 0.5 % royalty on net product sales of Libtayo until all such development costs have been reimbursed by Regeneron.
The following table summarizes contract balances in connection with the Company's IO Collaboration with Sanofi:
June 30, December 31,
(In millions) 2022 2021
Accounts receivable, net
$ 12.4 $ ( 22.5 )
Deferred revenue
$ 33.8 $ 16.0
Other liabilities
$ 241.0 $ 276.1
Other liabilities include up-front payments received from Sanofi for which recognition had been deferred. During the third quarter of 2022, in connection with the A&R IO LCA, the remaining IO Collaboration Other liabilities balance will be recorded as a reduction to the intangible asset described above.
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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 (aflibercept) and aflibercept 8 mg outside the United States. Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally.
Bayer markets EYLEA outside the United States and the companies share equally in profits and losses from sales. In Japan, the Company was entitled to receive a tiered percentage of between 33.5 % and 40.0 % of EYLEA net product sales through 2021, and effective January 1, 2022, the companies share equally in profits and losses from sales.
Amounts recognized in our Statements of Operations in connection with our Bayer collaboration are as follows:
Statement of Operations Classification Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2022 2021 2022 2021
Regeneron's share of profits in connection with commercialization of EYLEA outside the United States Collaboration revenue $ 339.7 $ 335.4 $ 678.1 $ 644.3
Reimbursement for manufacturing of ex-U.S. commercial supplies Collaboration revenue $ 17.8 $ 13.7 $ 42.8 $ 27.6
One-time payment in connection with change in Japan arrangement
Collaboration revenue $ — $ — $ 21.9 $ —
Reimbursement of research and development expenses
Reduction of Research and development expense
$ 9.8
$ 9.9 $ 20.9 $ 20.7
Regeneron's obligation for its share of Bayer research and development expenses
Research and development expense
$ ( 6.9 ) $ ( 10.9 ) $ ( 17.7 ) $ ( 23.4 )
The following table summarizes contract balances in connection with our Bayer collaboration:
June 30, December 31,
(In millions) 2022 2021
Accounts receivable, net $ 347.6 $ 355.5
Deferred revenue
$ 133.7 $ 129.4
c. U.S. Government
In 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 2020 and 2021, we entered into agreements to manufacture and deliver filled and finished drug product of REGEN-COV (casirivimab and imdevimab) to the U.S. government. In connection with one of our 2021 agreements, Roche supplied a portion of the doses to Regeneron to fulfill our agreement with the U.S. government (see "Roche" below for further details regarding our collaboration agreement with Roche).
As of December 31, 2021, the Company had completed its final deliveries of drug product under its agreements with the U.S. government. See Note 2 for REGEN-COV net product sales recognized during the three and six months ended June 30, 2021.
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d. Roche
In 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 studies.
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. Each quarter, a single payment is due from one party to the other to true-up the global gross profits between the parties. If Regeneron is to receive a true-up payment from Roche, such amount will be recorded to Collaboration revenue. If Regeneron is to make a true-up payment to Roche, such amount will be recorded to Cost of goods sold.
Amounts recognized in our Statements of Operations in connection with the Roche Collaboration Agreement are as follows:
Statement of Operations Classification Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2022 2021 2022 2021
Global gross profit payment from Roche in connection with sales of Ronapreve Collaboration revenue $ 8.2 $ 167.9 $ 224.5 $ 234.7
Reimbursement of research and development expenses from Roche (recorded as a reduction of Research and development expense) was $ 41.0 million and $ 127.8 million for the three and six months ended June 30, 2021. Such amounts were not material for the three and six months ended June 30, 2022.
The following table summarizes contract balances in connection with the Roche Collaboration Agreement:
June 30, December 31,
(In millions) 2022 2021
Accrued expenses and other current liabilities $ 5.8 $ 268.8
e. Alnylam
In 2018, the Company and Alnylam Pharmaceuticals, Inc. entered into a collaboration to discover RNA interference ("RNAi") therapeutics for NASH and potentially other related diseases, as well as to research, co-develop and commercialize any therapeutic product candidates that emerge from these discovery efforts (including ALN-HSD, which is currently in clinical development). The parties share equally, on an ongoing basis, development expenses for ALN-HSD.
In 2019, the parties entered into a global, strategic collaboration to discover, develop, and commercialize 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. For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation. Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-commercialization collaboration agreement structure (under which the parties are advancing ALN-APP, which is currently in clinical development) or a license agreement.
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 being developed by the Company (pozelimab), with the Company as the licensee. Under the C5 siRNA Co-Commercialization Collaboration Agreement, the parties share costs equally and under the License Agreement, the licensee is responsible for its own costs and expenses.
Amounts recognized in our Statements of Operations in connection with the Alnylam agreements described above were not material for the three and six months ended June 30, 2022 and 2021. In addition, contract balances in our Balance Sheets were not material as of June 30, 2022 and December 31, 2021.
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f. Checkmate
In May 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc. (“Checkmate”) for a total equity value of approximately $ 250 million. The Company made an assessment as to whether the set of assets acquired constituted a business and should be accounted for as a business combination. Given that substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset, vidutolimod, which is in clinical development for oncology, the transaction was accounted for as an asset acquisition. As a result of the acquisition, the Company recorded (i) a charge of $ 195.0 million to Acquired in-process research and development and (ii) net assets of $ 35.3 million, net of cash, related to the assets acquired (including deferred tax assets and investments) and liabilities assumed.
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) 2022 2021 2022 2021
Net income - basic and diluted $ 852.1 $ 3,098.9 $ 1,825.6 $ 4,214.1
Weighted average shares - basic 107.9 105.0 107.3 105.2
Effect of dilutive securities:
Stock options 4.7 4.8 4.9 4.7
Restricted stock awards and restricted stock units 1.4 1.0 1.4 0.8
Weighted average shares - diluted 114.0 110.8 113.6 110.7
Net income per share - basic $ 7.90 $ 29.51 $ 17.01 $ 40.06
Net income per share - diluted $ 7.47 $ 27.97 $ 16.07 $ 38.07
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) 2022 2021 2022 2021
Stock options 2.2 5.0 2.3 5.0
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5. Marketable Securities
Marketable securities as of June 30, 2022 and December 31, 2021 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, 2022
Cost Basis Gains Losses Value
Corporate bonds $ 7,849.1 $ 0.1 $ ( 271.0 ) $ 7,578.2
U.S. government and government agency obligations 1,051.8 — ( 5.8 ) 1,046.0
Sovereign bonds 45.9 — ( 1.8 ) 44.1
Commercial paper 669.2 — ( 1.4 ) 667.8
Certificates of deposit 337.5 — ( 0.9 ) 336.6
Asset-backed securities 40.9 — ( 1.5 ) 39.4
$ 9,994.4 $ 0.1 $ ( 282.4 ) $ 9,712.1
As of December 31, 2021
Corporate bonds $ 7,518.4 $ 10.2 $ ( 40.9 ) $ 7,487.7
U.S. government and government agency obligations 109.0 0.3 ( 0.8 ) 108.5
Sovereign bonds 64.4 0.3 ( 0.3 ) 64.4
Commercial paper 439.7 — ( 0.1 ) 439.6
Certificates of deposit 255.2 — ( 0.1 ) 255.1
Asset-backed securities 42.0 — ( 0.1 ) 41.9
$ 8,428.7 $ 10.8 $ ( 42.3 ) $ 8,397.2
The Company classifies its investments in available-for-sale debt securities based on their contractual maturity dates. The available-for-sale debt securities listed as of June 30, 2022 mature at various dates through April 2027. The fair values of available-for-sale debt securities by contractual maturity consist of the following:
June 30, December 31,
(In millions) 2022 2021
Maturities within one year $ 4,171.2 $ 2,809.1
Maturities after one year through five years 5,540.9 5,588.1
$ 9,712.1 $ 8,397.2
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The following table shows the fair value of the Company's available-for-sale debt securities that have unrealized losses, aggregated by investment category and length of time that the individual securities have been in a continuous loss position.
Less than 12 Months 12 Months or Greater Total
(In millions)
As of June 30, 2022
Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss
Corporate bonds $ 7,139.8 $ ( 251.8 ) $ 279.9 $ ( 19.2 ) $ 7,419.7 $ ( 271.0 )
U.S. government and government agency obligations 1,005.1 ( 5.7 ) 1.2 ( 0.1 ) 1,006.3 ( 5.8 )
Sovereign bonds 44.2 ( 1.8 ) — — 44.2 ( 1.8 )
Commercial paper 620.0 ( 1.4 ) — — 620.0 ( 1.4 )
Certificates of deposit 285.4 ( 0.9 ) — — 285.4 ( 0.9 )
Asset-backed securities 39.5 ( 1.5 ) — — 39.5 ( 1.5 )
$ 9,134.0 $ ( 263.1 ) $ 281.1 $ ( 19.3 ) $ 9,415.1 $ ( 282.4 )
As of December 31, 2021
Corporate bonds $ 5,889.3 $ ( 40.9 ) $ — $ — $ 5,889.3 $ ( 40.9 )
U.S. government and government agency obligations 90.0 ( 0.8 ) — — 90.0 ( 0.8 )
Sovereign bonds 37.0 ( 0.3 ) — — 37.0 ( 0.3 )
Commercial paper 295.7 ( 0.1 ) — — 295.7 ( 0.1 )
Certificates of deposit 169.4 ( 0.1 ) — — 169.4 ( 0.1 )
Asset-backed securities 34.9 ( 0.1 ) — — 34.9 ( 0.1 )
$ 6,516.3 $ ( 42.3 ) $ — $ — $ 6,516.3 $ ( 42.3 )
With respect to marketable securities, for the three and six months ended June 30, 2022 and 2021, amounts reclassified from Accumulated other comprehensive loss into Other (expense) income, net were related to realized gains and losses on sales of available-for-sale debt securities.
For the three and six months ended June 30, 2022 and 2021, realized gains and losses on sales of marketable securities were not material.
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6. Fair Value Measurements
The table below summarizes the Company's assets 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, 2022
Fair Value Level 1 Level 2
Available-for-sale debt securities:
Corporate bonds $ 7,578.2 $ — $ 7,578.2
U.S. government and government agency obligations 1,046.0 — 1,046.0
Sovereign bonds 44.1 — 44.1
Commercial paper 667.8 — 667.8
Certificates of deposit 336.6 — 336.6
Asset-backed securities 39.4 — 39.4
Equity securities (unrestricted) 35.2 35.2 —
Equity securities (restricted) 839.9 839.9 —
$ 10,587.2 $ 875.1 $ 9,712.1
As of December 31, 2021
Available-for-sale debt securities:
Corporate bonds $ 7,487.7 $ — $ 7,487.7
U.S. government and government agency obligations 108.5 — 108.5
Sovereign bonds 64.4 — 64.4
Commercial paper 439.6 — 439.6
Certificates of deposit 255.1 — 255.1
Asset-backed securities 41.9 — 41.9
Equity securities (unrestricted) 58.4 58.4 —
Equity securities (restricted) 1,191.5 1,191.5 —
$ 9,647.1 $ 1,249.9 $ 8,397.2
The Company held certain restricted equity securities as of June 30, 2022 which are subject to transfer restrictions that expire at various dates through 2024.
During the three and six months ended June 30, 2022, we recorded $ 163.7 million and $ 374.9 million of net unrealized losses, respectively, on equity securities in Other (expense) income, net. 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 (expense) income, net.
In addition to the investments summarized in the table above, as of June 30, 2022 and December 31, 2021, the Company had $ 47.3 million and $ 40.0 million, respectively, in equity investments that do not have a readily determinable fair value. These investments are recorded within Other noncurrent assets.
The fair value of our long-term debt (see Note 8), which was determined based on Level 2 inputs, was estimated to be $ 1.513 billion and $ 1.887 billion as of June 30, 2022 and December 31, 2021, respectively.
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7. Inventories
Inventories consist of the following:
June 30, December 31,
(In millions) 2022 2021
Raw materials $ 831.7 $ 721.9
Work-in-process 717.3 707.2
Finished goods 45.6 73.7
Deferred costs 623.9 448.5
$ 2,218.5 $ 1,951.3
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, 2022, Cost of goods sold included inventory write-offs and reserves totaling $ 19.2 million and $ 66.6 million, respectively. 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.
8. Debt
In 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) 2022 2021
1.750 % Senior Notes due September 2030
$ 1,240.4 $ 1,239.9
2.800 % Senior Notes due September 2050
740.3 740.1
$ 1,980.7 $ 1,980.0
Interest expense related to the Notes was $ 11.1 million and $ 22.2 million, respectively, for each of the three and six months ended June 30, 2022, and 2021.
9. Leases
In March 2022, we entered into a Second Amended and Restated Lease and Remedies Agreement (the "Restated Lease") with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital, LLC ("BAL"), as lessor (the "Lessor"), which amends, restates, and extends our lease of laboratory and office facilities in Tarrytown, New York (the "Facility"). In March 2022, we also entered into a Second Amended and Restated Participation Agreement (the "Restated Participation Agreement") with Bank of America, N.A., as administrative agent, the Lessor, and a syndicate of financial institutions as rent assignees (collectively with the Lessor, the "Participants"), which amends and restates the original Participation Agreement entered into in March 2017.
The original Participation Agreement and certain related agreements were amended and restated in order to, among other things, (i) effect a five-year extension of the original March 2022 maturity date of the $ 720.0 million lease financing (which was previously advanced in March 2017 to finance the purchase price for the Facility) and the end of the term of our lease of the Facility from the Lessor to March 2027, at which time all amounts outstanding thereunder will become due and payable in full, and (ii) modify the rate of the interest or yield that is payable to the Participants. In accordance with the terms of the Restated Lease, we continue to pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility. We are also required to make monthly payments of basic rent during the term of the Restated Lease in an amount equal to a variable rate per annum, which was modified in connection with the Restated Lease, to be an adjusted one-month forward-looking term rate based on the Secured Overnight Financing Rate ("SOFR"), plus an applicable margin that varies with our debt rating and total leverage ratio.
The Restated Participation Agreement and Restated Lease include an option for us to elect to further extend the maturity date of the Restated Participation Agreement and the term of the Restated Lease for an additional five-year period, subject to the consent of all the Participants and certain other conditions. We also have the option prior to the end of the term of the Restated Lease to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Restated Participation Agreement, all accrued and unpaid yield thereon, and all other outstanding amounts under the
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Restated Participation Agreement, Restated Lease, and certain related documents or (b) sell the Facility to a third party on behalf of the Lessor.
Consistent with the original lease, the Restated Lease continues to be classified as a finance lease as we have the option to purchase the Facility under terms that make it reasonably certain to be exercised. The agreements governing the Restated Lease financing contain financial and operating covenants. Such financial covenants and certain of the operating covenants are substantially similar to the covenants set forth in our $ 750.0 million revolving credit facility. The Company was in compliance with all such covenants as of June 30, 2022.
10. Income Taxes
The Company is subject to U.S. federal, state, and foreign income taxes. The Company's effective tax rate was 11.5 % and 17.4 % for the three months ended June 30, 2022 and 2021, respectively and 9.8 % and 15.8 % for the six months ended June 30, 2022 and 2021, respectively. The Company's effective tax rate for the three and six months ended June 30, 2022 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, to a lesser extent, stock-based compensation. 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, as these audits were effectively settled.
11. Stockholders' Equity
Share Repurchase Programs
In January 2021, our board of directors authorized a share repurchase program to repurchase up to $ 1.5 billion of our Common Stock. The share repurchase program permitted the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act. As of December 31, 2021, the Company had repurchased the entire $ 1.5 billion of its Common Stock that it was authorized to repurchase under the program.
In November 2021, our board of directors authorized an additional share repurchase program to repurchase up to $ 3.0 billion of our Common Stock. The share repurchase program was approved under terms substantially similar to the share repurchase program 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, 2022, $ 2.099 billion remained available for share repurchases under the November 2021 program.
The table below summarizes the shares of our Common Stock we repurchased under the programs 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) 2022 2021 2022 2021
Number of shares repurchased 0.7 0.6 1.2 1.3
Total cost of shares received $ 393.6 $ 288.6 $ 745.5 $ 612.1
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12. 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) 2022 2021
Cash and cash equivalents $ 3,395.1 $ 2,072.2
Restricted cash included in Other noncurrent assets
13.5 12.5
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statement of Cash Flows
$ 3,408.6 $ 2,084.7
Restricted cash consists of amounts held by financial institutions pursuant to contractual arrangements.
Supplemental disclosure of non-cash investing and financing activities
June 30, December 31, June 30, December 31,
(In millions) 2022 2021 2021 2020
Accrued capital expenditures $ 81.9 $ 74.8 $ 93.4 $ 83.6
13. 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, 2022 and December 31, 2021, the Company's accruals for loss contingencies were not material. If the Company were unable to prevail in any such proceedings, its consolidated financial position, results of operations, and future cash flows may be materially impacted.
Proceedings Relating to Praluent (alirocumab) Injection
As described in greater detail in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 and 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 of the Company's Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 for a description of the Company's and Sanofi's arrangement regarding the costs resulting from or associated with such actions. In addition, as described below, the Company filed a lawsuit against Amgen alleging that Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws.
United States
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 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. As previously reported, on February 11, 2021, the United States Court of Appeals for the Federal Circuit (the "Federal Circuit") affirmed the lower court's decision that certain of Amgen's asserted patent claims are invalid based on lack of enablement. On April 14, 2021, Amgen filed a petition for a rehearing en banc with the Federal Circuit, which was denied on June 21, 2021. On November 18, 2021, Amgen filed a petition for writ of certiorari with the United States Supreme Court.
On May 27, 2022, the Company filed a lawsuit against Amgen in the United States District Court for the District of Delaware, alleging that, beginning in 2020, Amgen engaged in an anticompetitive bundling scheme which was designed to exclude Praluent from the market in violation of federal and state laws. The lawsuit seeks damages for harm caused by the alleged scheme, as well as injunctive relief restraining Amgen from continuing its alleged anticompetitive conduct. On August 1, 2022, Amgen filed a motion to dismiss the complaint.
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Europe
Amgen has asserted European Patent No. 2,215,124 (the "'124 Patent"), which pertains to PCSK9 monoclonal antibodies, in certain countries in Europe. In October 2020, the '124 Patent claims directed to compositions of matter and medical use relevant to Praluent were ruled invalid based on a lack of inventive step by the Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO"). Following the EPO's decision, each of the '124 Patent infringement proceedings initiated by Amgen against the Company and certain of Sanofi's affiliated entities in these countries was dismissed, including in Germany. The dismissal in Germany followed an earlier finding of infringement and granting of an injunction, both of which were subsequently overturned. As a result of the overturned injunction in Germany discussed in the preceding sentence, the Company and/or certain of Sanofi's affiliated entities are seeking damages caused by Amgen's enforcement of the injunction. As part of its opposition to these damages claims, on March 23, 2022, Amgen filed a counterclaim that asserted the German designation of European Patent No. 2,641,917 (the "'917 Patent") and seeks, among other things, a judgment of patent infringement, injunctive relief, and monetary damages. The '917 Patent is a divisional patent of the '124 Patent discussed above (i.e., a patent that shares the same priority date, disclosure, and patent term of the parent '124 Patent but contains claims to a different invention). The '917 Patent is also subject to opposition proceedings in the EPO, which were initiated by Sanofi on May 5, 2021. An oral hearing before the EPO has been scheduled for February 21, 2023.
Proceedings Relating to Dupixent (dupilumab) Injection
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"), a patent owned by Immunex Corporation relating to antibodies that bind the human interleukin-4 receptor. At the joint request of the parties to the revocation proceeding, the U.K. Patents Court ordered on January 30, 2017 that the revocation action be stayed pending the final determination of the 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, which appeal was withdrawn at an oral hearing before the TBA on March 10, 2022 following the TBA's ruling discussed below. On May 18, 2022, the revocation action in the U.K. Patents Court was dismissed following the EPO's revocation of the '665 Patent. On September 20, 2017 and September 21, 2017, respectively, the Company and Sanofi initiated opposition proceedings in the EPO against Immunex's European Patent No. 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. At an oral hearing before the TBA on March 10, 2022, the TBA maintained the invalidity and revocation of the '420 Patent. The original patent term of the Immunex patents expired in May 2021.
Proceedings Relating to EYLEA (aflibercept) Injection
United States
On February 11, 2020, anonymous parties filed two requests for ex parte reexamination of the Company's U.S. Patent Nos. 10,406,226 and 10,464,992, and the United States Patent and Trademark Office ("USPTO") has granted both requests to initiate reexamination proceedings.
On May 5, 2021, Mylan Pharmaceuticals Inc. filed inter partes review ("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. On November 10, 2021, the USPTO issued a decision instituting both IPR proceedings. On December 9, 2021, Apotex Inc. and Celltrion, Inc. each filed two separate IPR petitions against the Company's '338 and '069 Patents requesting that their IPRs be instituted and joined with the IPR proceedings initiated by Mylan concerning the '338 and '069 Patents, which petitions were granted on February 9, 2022. An oral hearing has been scheduled for August 10, 2022.
On September 7, 2021, Celltrion, Inc. filed a post-grant review ("PGR") petition in the USPTO against the Company's U.S. Patent No. 10,857,231 (the "'231 Patent") seeking a declaration of invalidity of the '231 Patent. On March 14, 2022, the Company filed a Notice of Disclaimer with the USPTO, disclaiming all claims of the '231 Patent. As a result, on March 15, 2022, the USPTO denied institution of Celltrion's PGR petition.
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Europe
On October 26 and October 27, 2021, anonymous parties initiated opposition proceedings in the EPO against the Company's European Patent No. 2,944,306 (the "'306 Patent") seeking revocation of the '306 Patent in its entirety.
Canada
On June 15 and July 15, 2022, the Company and Bayer Inc. filed patent infringement lawsuits against BGP Pharma ULC d.b.a Viatris Canada and two additional defendants in the Federal Court of Canada seeking a declaration that the making, constructing, using, or selling of an aflibercept biosimilar would directly or indirectly infringe one or more claims of the Company's Canadian Patent Nos. 2,654,510 and 3,007,276 (in the lawsuit filed on June 15, 2022) and the Company's Canadian Patent No. 2,965,495 (in the lawsuit filed on July 15, 2022).
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"). 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 (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. Novartis also seeks a judgment of patent infringement of the '631 Patent, monetary damages (together with interest), an order of willful infringement of the '631 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuits, and attorneys' fees. On July 30, 2020, the court granted the Company's motion to stay these proceedings until a determination in the ITC proceedings discussed above, including any appeals therefrom, becomes final. On June 11, 2021, the court, at the request of Novartis, lifted the stay. On November 5, 2021, the Company filed a motion to stay these proceedings in light of the pending IPR proceeding discussed below. On January 31, 2022, the court denied the Company's motion to stay these proceedings.
On 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 October 26, 2021, the USPTO issued a decision instituting the IPR proceeding. An oral hearing was held on July 21, 2022.
On July 17, 2020, the Company filed an antitrust lawsuit against Novartis and Vetter Pharma International Gmbh ("Vetter") in the United States District Court for the Southern District of New York seeking a declaration that the '631 Patent is unenforceable and a judgment that the defendants' conduct violates Sections 1 and 2 of the Sherman Antitrust Act of 1890, as amended (the "Sherman Antitrust Act"). The Company is also seeking injunctive relief and treble damages. On September 4, 2020, Novartis filed, and Vetter moved to join, a motion to dismiss the complaint, to transfer the lawsuit to the Northern District of New York, or to stay the suit; and on October 19, 2020, Novartis filed, and Vetter moved to join, a second motion to dismiss the complaint on different grounds. On January 25, 2021, the Company filed an amended complaint seeking a judgment that Novartis's conduct violates Section 2 of the Sherman Antitrust Act based on additional grounds, as well as a judgment of tortious interference with contract. On February 22, 2021, Novartis filed, and Vetter moved to join, a motion to dismiss the amended complaint. On September 21, 2021, the court granted Novartis and Vetter's motion to transfer this lawsuit to the Northern District of New York. As a result, this lawsuit was transferred to the same judge that had been assigned to the patent infringement lawsuit discussed above. On November 5, 2021, the Company filed a motion to stay these proceedings in light of the pending IPR proceeding discussed above. On January 31, 2022, the court denied the Company's motion to stay these proceedings and granted Novartis and Vetter's motion to dismiss the amended complaint. On June 10, 2022, the Company filed an appeal of the District Court's decision to dismiss the amended complaint with the U.S. Court of Appeals for the Second Circuit.
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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. As previously reported, on July 29, 2021, the '711 Patent was revoked in its entirety by the TBA of the EPO.
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 was held on April 5, 2022, at which the TBA ruled that the '048 Patent claims directed to compositions of matter and medical use relevant to fasinumab were invalid based on a lack of novelty.
Proceedings Relating to REGEN-COV (casirivimab and imdevimab)
On October 5, 2020, Allele Biotechnology and Pharmaceuticals, Inc. ("Allele") filed a lawsuit (as amended on April 8, 2021) against the Company in the United States District Court for the Southern District of New York, asserting infringement of U.S. Patent No. 10,221,221 (the "'221 Patent"). Allele seeks a judgment of patent infringement of the '221 Patent, an award of monetary damages (together with interest), an order of willful infringement of the '221 Patent (which would allow the court in its discretion to award damages up to three times the amount assessed), costs and expenses of the lawsuit, and attorneys' fees. On July 16, 2021, the Company filed a motion to dismiss the complaint, which motion was denied on March 2, 2022.
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 of the United States and various states (the "State Plaintiffs"), asserting causes of action under the federal False Claims Act and state law. Also on June 3, 2021, the United States and the State Plaintiffs notified the court of their decision to decline to intervene in the case. On October 29, 2021, the qui tam plaintiffs filed an amended complaint in this matter. On January 14, 2022, the Company filed a motion to dismiss the amended complaint in its entirety.
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.
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Proceedings Initiated by Medicare Advantage Plans Relating to Patient Assistance Organization Support
The Company is party to several lawsuits relating to the conduct alleged in the civil complaint filed by the U.S. Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above. These lawsuits were filed by UnitedHealthcare Insurance Company and United Healthcare Services, Inc. (collectively, "UHC") and Humana Inc. ("Humana") in the United States District Court for the Southern District of New York on December 17, 2020 and July 22, 2021, respectively; and by Blue Cross and Blue Shield of Massachusetts, Inc. and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc. (collectively, "BCBS"), Medical Mutual of Ohio ("MMO"), Horizon Healthcare Services, Inc. d/b/a Horizon Blue Cross Blue Shield of New Jersey ("Horizon"), and Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund ("Local 464A") in the U.S. District Court for the District of Massachusetts on December 20, 2021, February 23, 2022, April 4, 2022, and June 17, 2022, respectively. These lawsuits allege causes of action under state law and the federal Racketeer Influenced and Corrupt Organizations Act and seek monetary damages and equitable relief. The MMO and Local 464A lawsuits are putative class action lawsuits. On December 29, 2021, the lawsuits filed by UHC and Humana were stayed by the United States District Court for the Southern District of New York pending resolution of the proceedings before the U.S. District Court for the District of Massachusetts discussed under "Department of Justice Matters" above. In the BCBS, MMO, and Horizon matters, on May 31, 2022, June 6, 2022, and June 13, 2022, respectively, the Company filed motions to transfer the actions to the United States District Court of the Southern District of New York or, in the alternative, to stay the actions in favor of the proceedings before the U.S. District Court for the District of Massachusetts discussed under "Department of Justice Matters" above; or to dismiss the complaints with prejudice.
Shareholder Demands
On or about September 30, 2020, March 30, 2022, and March 31, 2022, the Company's board of directors received three demand letters from purported shareholders of the Company. The demands allege that Regeneron and its shareholders have been damaged by the conduct alleged in the civil complaint filed by the U.S. Attorney's Office for the District of Massachusetts discussed under "Department of Justice Matters" above. The demand letters request that the Company's board of directors investigate alleged breaches of fiduciary duty by its officers and directors and other alleged violations of law and corporate governance practices and procedures; bring legal action against the persons responsible for causing the alleged damages; and implement and maintain an effective system of internal controls, compliance mechanisms, and corporate governance practices and procedures. The Company's board of directors, working with outside counsel, investigated and evaluated the allegations in the demand letters and has concluded that pursuing the claims alleged in the demands would not be in the Company's best interests at this time.
Proceedings Relating to Shareholder Derivative Complaint
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. On September 23, 2021, the individual defendants moved to dismiss the complaint in its entirety. Also on September 23, 2021, the plaintiff moved to remand the case to the New York Supreme Court.
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