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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
| | | | | | | | | | | |
(Mark One) | | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the quarterly period ended September 30, 2022 |
| OR | | |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the transition period from __________ to __________ |
| | | | | | | | | | | |
| Commission File Number: 0-19034 | |
REGENERON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| | | | | | | | |
New York | | 13-3444607 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| | | | | | | | | | | |
777 Old Saw Mill River Road, Tarrytown, New York 10591-6707 |
(Address of principal executive offices, including zip code) |
(914) 847-7000
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
Title of each class | Trading Symbol | Name of each exchange on which registered |
Common Stock - par value $.001 per share | REGN | NASDAQ Global Select Market |
| | | | | | | | | | | | | | |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. | Yes | ☒ | No | ☐ |
| | | | |
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). | Yes | ☒ | No | ☐ |
| | |
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act. |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Large accelerated filer | ☒ | | Accelerated filer | ☐ | | Non-accelerated filer | ☐ | | Smaller reporting company | ☐ | | Emerging growth company | ☐ | | |
| | | | | | | | | | | | | | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. | | ☐ | | |
| | | | |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). | Yes | ☐ | No | ☒ |
The number of shares outstanding of each of the registrant's classes of common stock as of October 24, 2022:
| | | | | | | | |
Class of Common Stock | | Number of Shares |
Class A Stock, $.001 par value | | 1,818,146 |
Common Stock, $.001 par value | | 107,083,789 |
REGENERON PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
TABLE OF CONTENTS
| | |
"ARCALYST®," "Evkeeza®," "EYLEA®," "Inmazeb®," "Libtayo®," "Praluent®" (in the United States), "REGEN-COV®," "Regeneron®," "Regeneron Genetics Center®," "RGC™," "Veloci-Bi®," "VelociGene®," "VelociHum®," "VelociMab®," "VelocImmune®," "VelociMouse®," "VelociSuite®," "VelociT®," and "ZALTRAP®" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners. This report refers to products of Regeneron Pharmaceuticals, Inc., its collaborators, and other parties. Consult the product label in each territory for specific information about such products. |
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In millions, except per share data) | | | | | | | | | | | |
| September 30, | | December 31, |
| 2022 | | 2021 |
ASSETS |
Current assets: | | | |
Cash and cash equivalents | $ | 3,491.3 | | | $ | 2,885.6 | |
Marketable securities | 3,530.4 | | | 2,809.1 | |
Accounts receivable, net | 5,548.3 | | | 6,036.5 | |
Inventories | 2,412.2 | | | 1,951.3 | |
Prepaid expenses and other current assets | 446.4 | | | 332.4 | |
Total current assets | 15,428.6 | | | 14,014.9 | |
| | | |
Marketable securities | 5,968.6 | | | 6,838.0 | |
Property, plant, and equipment, net | 3,704.2 | | | 3,482.2 | |
Intangible assets, net | 804.1 | | | 6.7 | |
Deferred tax assets | 1,452.1 | | | 876.9 | |
Other noncurrent assets | 320.2 | | | 216.1 | |
Total assets | $ | 27,677.8 | | | $ | 25,434.8 | |
| | | |
LIABILITIES AND STOCKHOLDERS' EQUITY |
Current liabilities: | | | |
Accounts payable | $ | 535.6 | | | $ | 564.0 | |
Accrued expenses and other current liabilities | 1,796.4 | | | 2,206.8 | |
Finance lease liabilities | — | | | 719.7 | |
Deferred revenue | 547.2 | | | 442.0 | |
Total current liabilities | 2,879.2 | | | 3,932.5 | |
| | | |
Long-term debt | 1,981.1 | | | 1,980.0 | |
Finance lease liabilities | 720.0 | | | — | |
Deferred revenue | 60.1 | | | 73.3 | |
Other noncurrent liabilities | 598.6 | | | 680.2 | |
Total liabilities | 6,239.0 | | | 6,666.0 | |
| | | |
Stockholders' equity: | | | |
Preferred Stock, par value $.01 per share; 30.0 shares authorized; issued and outstanding - none | — | | | — | |
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 - 129.0 in 2022 and 126.2 in 2021 | 0.1 | | | 0.1 | |
Additional paid-in capital | 9,518.2 | | | 8,087.5 | |
Retained earnings | 22,109.6 | | | 18,968.3 | |
Accumulated other comprehensive loss | (275.1) | | | (26.2) | |
Treasury Stock, at cost; 22.0 shares in 2022 and 19.4 shares in 2021 | (9,914.0) | | | (8,260.9) | |
Total stockholders' equity | 21,438.8 | | | 18,768.8 | |
Total liabilities and stockholders' equity | $ | 27,677.8 | | | $ | 25,434.8 | |
| | | |
The accompanying notes are an integral part of the financial statements. |
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Unaudited)
(In millions, except per share data)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Statements of Operations | | | | | | | | |
Revenues: | | | | | | | | |
Net product sales | | $ | 1,801.4 | | | $ | 2,279.9 | | | $ | 5,194.4 | | | $ | 8,142.0 | |
Collaboration revenue | | 1,050.6 | | | 1,073.9 | | | 3,326.7 | | | 2,783.0 | |
Other revenue | | 84.2 | | | 99.0 | | | 237.4 | | | 195.0 | |
| | 2,936.2 | | | 3,452.8 | | | 8,758.5 | | | 11,120.0 | |
| | | | | | | | |
Expenses: | | | | | | | | |
Research and development | | 911.3 | | | 665.4 | | | 2,549.4 | | | 2,122.5 | |
Acquired in-process research and development | | — | | | — | | | 225.1 | | | — | |
Selling, general, and administrative | | 529.1 | | | 445.0 | | | 1,455.4 | | | 1,265.3 | |
Cost of goods sold | | 141.3 | | | 238.8 | | | 497.8 | | | 961.4 | |
Cost of collaboration and contract manufacturing | | 176.5 | | | 214.4 | | | 522.0 | | | 493.5 | |
Other operating (income) expense, net | | (45.7) | | | 42.0 | | | (83.3) | | | (29.8) | |
| | 1,712.5 | | | 1,605.6 | | | 5,166.4 | | | 4,812.9 | |
| | | | | | | | |
Income from operations | | 1,223.7 | | | 1,847.2 | | | 3,592.1 | | | 6,307.1 | |
| | | | | | | | |
Other income (expense): | | | | | | | | |
Other income (expense), net | | 301.4 | | | (16.4) | | | (16.0) | | | 558.5 | |
Interest expense | | (15.3) | | | (14.2) | | | (42.0) | | | (43.2) | |
| | 286.1 | | | (30.6) | | | (58.0) | | | 515.3 | |
| | | | | | | | |
Income before income taxes | | 1,509.8 | | | 1,816.6 | | | 3,534.1 | | | 6,822.4 | |
| | | | | | | | |
Income tax expense | | 194.1 | | | 184.4 | | | 392.8 | | | 976.1 | |
| | | | | | | | |
Net income | | $ | 1,315.7 | | | $ | 1,632.2 | | | $ | 3,141.3 | | | $ | 5,846.3 | |
| | | | | | | | |
Net income per share - basic | | $ | 12.31 | | | $ | 15.37 | | | $ | 29.30 | | | $ | 55.42 | |
Net income per share - diluted | | $ | 11.66 | | | $ | 14.33 | | | $ | 27.73 | | | $ | 52.29 | |
| | | | | | | | |
Weighted average shares outstanding - basic | | 106.9 | | | 106.2 | | | 107.2 | | | 105.5 | |
Weighted average shares outstanding - diluted | | 112.8 | | | 113.9 | | | 113.3 | | | 111.8 | |
| | | | | | | | |
Statements of Comprehensive Income | | | | | | | | |
Net income | | $ | 1,315.7 | | | $ | 1,632.2 | | | $ | 3,141.3 | | | $ | 5,846.3 | |
Other comprehensive income (loss), net of tax: | | | | | | | | |
Unrealized loss on debt securities | | (51.3) | | | (6.4) | | | (249.9) | | | (20.5) | |
Unrealized gain on cash flow hedges | | — | | | 0.2 | | | 1.0 | | | 0.7 | |
Comprehensive income | | $ | 1,264.4 | | | $ | 1,626.0 | | | $ | 2,892.4 | | | $ | 5,826.5 | |
| | | | | | | | |
The accompanying notes are an integral part of the financial statements. |
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 | |
Issuance of Common Stock for equity awards granted under long-term incentive plans | | — | | | — | | | 0.9 | | | — | | | 322.9 | | | — | | | — | | | — | | | — | | | 322.9 | |
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations | | — | | | — | | | (0.2) | | | — | | | (108.9) | | | — | | | — | | | — | | | — | | | (108.9) | |
Issuance/distribution of Common Stock for 401(k) Savings Plan | | — | | | — | | | — | | | — | | | 12.9 | | | — | | | — | | | — | | | 1.6 | | | 14.5 | |
Repurchases of Common Stock | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (1.4) | | | (913.0) | | | (913.0) | |
Stock-based compensation charges | | — | | | — | | | — | | | — | | | 171.1 | | | — | | | — | | | — | | | — | | | 171.1 | |
Net income | | — | | | — | | | — | | | — | | | — | | | 1,315.7 | | | — | | | — | | | — | | | 1,315.7 | |
Other comprehensive loss, net of tax | | — | | | — | | | — | | | — | | | — | | | — | | | (51.3) | | | — | | | — | | | (51.3) | |
Balance, September 30, 2022 | | 1.8 | | | $ | — | | | 129.0 | | | $ | 0.1 | | | $ | 9,518.2 | | | $ | 22,109.6 | | | $ | (275.1) | | | (22.0) | | | $ | (9,914.0) | | | $ | 21,438.8 | |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | |
Issuance of Common Stock for equity awards granted under long-term incentive plans | | — | | | — | | | 2.5 | | | — | | | 816.5 | | | — | | | — | | | — | | | — | | | 816.5 | |
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations | | — | | | — | | | (0.4) | | | — | | | (269.6) | | | — | | | — | | | — | | | — | | | (269.6) | |
Issuance/distribution of Common Stock for 401(k) Savings Plan | | — | | | — | | | — | | | — | | | 10.2 | | | — | | | — | | | — | | | 1.8 | | | 12.0 | |
Repurchases of Common Stock | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (0.2) | | | (190.6) | | | (190.6) | |
Stock-based compensation charges | | — | | | — | | | — | | | — | | | 136.4 | | | — | | | — | | | — | | | — | | | 136.4 | |
Net income | | — | | | — | | | — | | | — | | | — | | | 1,632.2 | | | — | | | — | | | — | | | 1,632.2 | |
Other comprehensive loss, net of tax | | — | | | — | | | — | | | — | | | — | | | — | | | (6.2) | | | — | | | — | | | (6.2) | |
Balance, September 30, 2021 | | 1.8 | | $ | — | | | 124.6 | | $ | 0.1 | | | $ | 7,919.3 | | | $ | 16,739.3 | | | $ | 9.5 | | | (17.9) | | | $ | (7,410.2) | | | $ | 17,258.0 | |
| | | | | | | | | | | | | | | | | | | | |
The accompanying notes are an integral part of the financial statements. |
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(In millions)
| | | | | | | | | | | | | | |
| | Nine Months Ended September 30, |
| | 2022 | | 2021 |
Cash flows from operating activities: | | | | |
Net income | | $ | 3,141.3 | | | $ | 5,846.3 | |
Adjustments to reconcile net income to net cash provided by operating activities: | | | | |
Depreciation and amortization | | 241.3 | | | 211.7 | |
Stock-based compensation expense | | 493.0 | | | 413.3 | |
Losses (gains) on marketable and other securities, net | | 117.4 | | | (524.6) | |
Other non-cash items, net | | 199.0 | | | 264.4 | |
Deferred taxes | | (466.7) | | | 58.8 | |
Acquired in-process research and development in connection with asset acquisition | | 195.0 | | | — | |
Changes in assets and liabilities: | | | | |
Decrease (increase) in accounts receivable | | 488.2 | | | (1,342.9) | |
Increase in inventories | | (552.2) | | | (330.6) | |
Increase in prepaid expenses and other assets | | (167.3) | | | (316.8) | |
Increase (decrease) in deferred revenue | | 92.0 | | | (71.2) | |
(Decrease) increase in accounts payable, accrued expenses, and other liabilities | | (486.0) | | | 500.4 | |
Total adjustments | | 153.7 | | | (1,137.5) | |
Net cash provided by operating activities | | 3,295.0 | | | 4,708.8 | |
| | | | |
Cash flows from investing activities: | | | | |
Purchases of marketable and other securities | | (4,345.0) | | | (4,872.3) | |
Sales or maturities of marketable and other securities | | 4,013.1 | | | 1,897.3 | |
Capital expenditures | | (437.9) | | | (397.0) | |
Payments for Libtayo intangible asset | | (926.8) | | | — | |
Asset acquisition, net of cash acquired | | (230.3) | | | — | |
Net cash used in investing activities | | (1,926.9) | | | (3,372.0) | |
| | | | |
Cash flows from financing activities: | | | | |
Proceeds from issuance of Common Stock | | 1,146.9 | | | 1,129.6 | |
Payments in connection with Common Stock tendered for employee tax obligations | | (256.6) | | | (450.3) | |
Repurchases of Common Stock | | (1,651.7) | | | (778.5) | |
Net cash used in financing activities | | (761.4) | | | (99.2) | |
| | | | |
Net increase in cash, cash equivalents, and restricted cash | | 606.7 | | | 1,237.6 | |
| | | | |
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 | | $ | 3,504.8 | | | $ | 3,444.9 | |
| | | | |
The accompanying notes are an integral part of the financial statements. |
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.
Certain reclassifications have been made to prior period amounts to conform with the current period's presentation.
Beginning with the first quarter of 2022, the Company added a new line item, Acquired in-process research and development, to its 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 nine months ended September 30, 2022 would have historically been recorded to Research and development expenses. No such amounts were recorded for the three and nine months ended September 30, 2021.
2. Product Sales
Net product sales consist of the following:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | Three Months Ended September 30, | | Nine Months Ended September 30, |
(In millions) | | | 2022 | | 2021 | | 2022 | | 2021 |
EYLEA® | U.S. | | $ | 1,629.4 | | | $ | 1,473.4 | | | $ | 4,768.2 | | | $ | 4,245.1 | |
Libtayo®(a) | U.S. | | 94.7 | | | 78.4 | | | 264.5 | | | 225.5 | |
| ROW(b) | | 31.0 | | | — | | | 31.0 | | | — | |
Praluent® | U.S. | | 29.7 | | | 44.8 | | | 94.5 | | | 130.0 | |
REGEN-COV®(c) | U.S. | | — | | | 676.7 | | | — | | | 3,530.1 | |
Evkeeza® | U.S. | | 13.6 | | | 6.6 | | | 33.2 | | | 9.1 | |
Inmazeb® | U.S. | | 3.0 | | | — | | | 3.0 | | | — | |
ARCALYST®(d) | U.S. | | — | | | — | | | — | | | 2.2 | |
| | | $ | 1,801.4 | | | $ | 2,279.9 | | | $ | 5,194.4 | | | $ | 8,142.0 | |
| | | | | | | | | |
(a) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States. Effective July 1, 2022, the Company began recording net product sales of Libtayo outside the United States. See Note 3 for further details. |
(b) Rest of world ("ROW") |
(c) 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. |
(d) Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States. Previously, the Company recorded net product sales of ARCALYST in the United States. |
As of September 30, 2022 and December 31, 2021, the Company had $4.268 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 nine months ended September 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 September 30, | | Nine Months Ended September 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Besse Medical, a subsidiary of AmerisourceBergen Corporation | | 56 | % | | 40 | |