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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 June 30, 2020 | | |
| 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 July 23, 2020:
| | | | | | | | |
Class of Common Stock | | Number of Shares |
Class A Stock, $.001 par value | | 1,848,970 |
Common Stock, $.001 par value | | 104,543,424 |
REGENERON PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
TABLE OF CONTENTS
| | |
"ARCALYST®," "EYLEA®," "Libtayo®" (in the United States), "Praluent®" (in the United States), "Regeneron®," "Regeneron Genetics Center®," "Veloci-Bi®," "VelociGene®," "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. |
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In millions, except share data)
| | | | | | | | | | | |
| June 30, | | December 31, |
| 2020 | | 2019 |
ASSETS | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 1,992.2 | | | $ | 1,617.8 | |
Marketable securities | 1,152.0 | | | 1,596.5 | |
Accounts receivable - trade, net | 1,991.0 | | | 2,100.0 | |
Accounts receivable - Sanofi | 389.2 | | | 260.6 | |
Accounts receivable - other | 431.1 | | | 425.0 | |
Inventories | 1,640.9 | | | 1,415.5 | |
Prepaid expenses and other current assets | 263.8 | | | 273.7 | |
Total current assets | 7,860.2 | | | 7,689.1 | |
| | | |
Marketable securities | 2,587.6 | | | 3,256.8 | |
Property, plant, and equipment, net | 3,031.4 | | | 2,890.4 | |
Deferred tax assets | 774.0 | | | 824.2 | |
Other noncurrent assets | 175.5 | | | 144.7 | |
Total assets | $ | 14,428.7 | | | $ | 14,805.2 | |
| | | |
LIABILITIES AND STOCKHOLDERS' EQUITY | | | |
Current liabilities: | | | |
Accounts payable | $ | 380.1 | | | $ | 418.1 | |
Accrued expenses and other current liabilities | 1,257.0 | | | 1,211.4 | |
Debt | 1,500.0 | | | — | |
Deferred revenue - Sanofi | 380.2 | | | 310.5 | |
Deferred revenue - other | 81.3 | | | 71.6 | |
Other liabilities - Sanofi | 103.8 | | | 85.0 | |
Total current liabilities | 3,702.4 | | | 2,096.6 | |
| | | |
Finance lease liabilities | 715.9 | | | 713.9 | |
Deferred revenue - Sanofi | 37.8 | | | 27.7 | |
Deferred revenue - other | 67.0 | | | 77.6 | |
Other liabilities - Sanofi | 390.3 | | | 482.0 | |
Other noncurrent liabilities | 457.9 | | | 317.7 | |
Total liabilities | 5,371.3 | | | 3,715.5 | |
| | | |
Stockholders' equity: | | | |
Preferred Stock, $.01 par value; 30,000,000 shares authorized; issued and outstanding - none | — | | | — | |
Class A Stock, convertible, $.001 par value; 40,000,000 shares authorized; shares issued and outstanding - 1,848,970 in 2020 and 2019 | — | | | — | |
Common Stock, $.001 par value; 320,000,000 shares authorized; shares issued - 119,757,931 in 2020 and 113,288,103 in 2019 | 0.1 | | | 0.1 | |
Additional paid-in capital | 6,263.0 | | | 4,428.6 | |
Retained earnings | 8,901.7 | | | 7,379.8 | |
Accumulated other comprehensive income | 35.5 | | | 21.1 | |
Treasury Stock, at cost; 15,578,240 shares in 2020 and 4,860,123 shares in 2019 | (6,142.9) | | | (739.9) | |
Total stockholders' equity | 9,057.4 | | | 11,089.7 | |
Total liabilities and stockholders' equity | $ | 14,428.7 | | | $ | 14,805.2 | |
| | | |
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 June 30, | | | | Six Months Ended June 30, | | |
| | 2020 | | 2019 | | 2020 | | 2019 |
Statements of Operations | | | | | | | | |
Revenues: | | | | | | | | |
Net product sales | | $ | 1,226.9 | | | $ | 1,205.3 | | | $ | 2,463.6 | | | $ | 2,309.7 | |
Sanofi collaboration revenue | | 269.1 | | | 75.8 | | | 516.0 | | | 57.8 | |
Bayer collaboration revenue | | 244.2 | | | 277.2 | | | 525.6 | | | 541.2 | |
Other revenue | | 211.8 | | | 19.5 | | | 275.0 | | | 41.7 | |
| | 1,952.0 | | | 1,577.8 | | | 3,780.2 | | | 2,950.4 | |
| | | | | | | | |
Expenses: | | | | | | | | |
Research and development | | 722.0 | | | 885.5 | | | 1,305.9 | | | 1,371.6 | |
Selling, general, and administrative | | 348.3 | | | 294.6 | | | 715.6 | | | 585.7 | |
Cost of goods sold | | 102.5 | | | 67.0 | | | 181.3 | | | 137.9 | |
Cost of collaboration and contract manufacturing | | 173.0 | | | 78.8 | | | 311.5 | | | 180.0 | |
Other operating (income) expense, net | | (50.2) | | | (63.7) | | | (90.6) | | | (120.4) | |
| | 1,295.6 | | | 1,262.2 | | | 2,423.7 | | | 2,154.8 | |
| | | | | | | | |
Income from operations | | 656.4 | | | 315.6 | | | 1,356.5 | | | 795.6 | |
| | | | | | | | |
Other income (expense): | | | | | | | | |
Other income (expense), net | | 272.2 | | | (82.9) | | | 246.8 | | | (9.1) | |
Interest expense | | (9.7) | | | (8.0) | | | (15.8) | | | (15.7) | |
| | 262.5 | | | (90.9) | | | 231.0 | | | (24.8) | |
| | | | | | | | |
Income before income taxes | | 918.9 | | | 224.7 | | | 1,587.5 | | | 770.8 | |
| | | | | | | | |
Income tax expense | | 21.6 | | | 31.6 | | | 65.6 | | | 116.6 | |
| | | | | | | | |
Net income | | $ | 897.3 | | | $ | 193.1 | | | $ | 1,521.9 | | | $ | 654.2 | |
| | | | | | | | |
Net income per share - basic | | $ | 8.19 | | | $ | 1.77 | | | $ | 13.87 | | | $ | 6.00 | |
Net income per share - diluted | | $ | 7.61 | | | $ | 1.68 | | | $ | 13.03 | | | $ | 5.69 | |
| | | | | | | | |
Weighted average shares outstanding - basic | | 109.6 | | | 109.2 | | | 109.7 | | | 109.1 | |
Weighted average shares outstanding - diluted | | 117.9 | | | 114.6 | | | 116.8 | | | 115.0 | |
| | | | | | | | |
Statements of Comprehensive Income | | | | | | | | |
Net income | | $ | 897.3 | | | $ | 193.1 | | | $ | 1,521.9 | | | $ | 654.2 | |
Other comprehensive income (loss), net of tax: | | | | | | | | |
Unrealized gain on debt securities | | 44.6 | | | 14.4 | | | 15.8 | | | 30.5 | |
Unrealized loss on cash flow hedges | | — | | | (1.4) | | | (1.4) | | | (2.4) | |
Comprehensive income | | $ | 941.9 | | | $ | 206.1 | | | $ | 1,536.3 | | | $ | 682.3 | |
| | | | | | | | |
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, 2019 | | 1.8 | | | — | | | 113.3 | | | $ | 0.1 | | | $ | 4,428.6 | | | $ | 7,379.8 | | | $ | 21.1 | | | (4.9) | | | $ | (739.9) | | | $ | 11,089.7 | |
Issuance of Common Stock for equity awards granted under long-term incentive plans | | — | | | — | | | 3.1 | | | — | | | 817.4 | | | — | | | — | | | — | | | — | | | 817.4 | |
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations | | — | | | — | | | (0.4) | | | — | | | (155.1) | | | — | | | — | | | — | | | — | | | (155.1) | |
Issuance/distribution of Common Stock for 401(k) Savings Plan | | — | | | — | | | — | | | — | | | 12.5 | | | — | | | — | | | — | | | 2.1 | | | 14.6 | |
Repurchases of Common Stock | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (0.8) | | | (336.0) | | | (336.0) | |
Stock-based compensation charges | | — | | | — | | | — | | | — | | | 108.0 | | | — | | | — | | | — | | | — | | | 108.0 | |
Net income | | — | | | — | | | — | | | — | | | — | | | 624.6 | | | — | | | — | | | — | | | 624.6 | |
Other comprehensive loss, net of tax | | — | | | — | | | — | | | — | | | — | | | — | | | (30.2) | | | — | | | — | | | (30.2) | |
Balance, March 31, 2020 | | 1.8 | | | — | | | 116.0 | | | 0.1 | | | 5,211.4 | | | 8,004.4 | | | (9.1) | | | (5.7) | | | (1,073.8) | | | 12,133.0 | |
Issuance of Common Stock for equity awards granted under long-term incentive plans | | — | | | — | | | 4.4 | | | — | | | 1,355.5 | | | — | | | — | | | — | | | — | | | 1,355.5 | |
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations | | — | | | — | | | (0.6) | | | — | | | (416.5) | | | — | | | — | | | — | | | — | | | (416.5) | |
Issuance/distribution of Common Stock for 401(k) Savings Plan | | — | | | — | | | — | | | — | | | 7.4 | | | — | | | — | | | — | | | 2.7 | | | 10.1 | |
Repurchases of Common Stock | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (9.9) | | | (5,071.8) | | | (5,071.8) | |
Stock-based compensation charges | | — | | | — | | | — | | | — | | | 105.2 | | | — | | | — | | | — | | | — | | | 105.2 | |
Net income | | — | | | — | | | — | | | — | | | — | | | 897.3 | | | — | | | — | | | — | | | 897.3 | |
Other comprehensive income, net of tax | | — | | | — | | | — | | | — | | | — | | | — | | | 44.6 | | | — | | | — | | | 44.6 | |
Balance, June 30, 2020 | | 1.8 | | | — | | | 119.8 | | | $ | 0.1 | | | $ | 6,263.0 | | | $ | 8,901.7 | | | $ | 35.5 | | | (15.6) | | | $ | (6,142.9) | | | $ | 9,057.4 | |
| | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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, 2018 | | 1.9 | | | — | | | 111.1 | | | $ | 0.1 | | | $ | 3,911.6 | | | $ | 5,254.3 | | | $ | (12.3) | | | (4.0) | | | $ | (396.4) | | | $ | 8,757.3 | |
Issuance of Common Stock for equity awards granted under long-term incentive plans | | — | | | — | | | 0.6 | | | — | | | 140.9 | | | — | | | — | | | — | | | — | | | 140.9 | |
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations | | — | | | — | | | — | | | — | | | (10.7) | | | — | | | — | | | — | | | — | | | (10.7) | |
Issuance of Common Stock for 401(k) Savings Plan | | — | | | — | | | — | | | — | | | 4.3 | | | — | | | — | | | 0.1 | | | 6.2 | | | 10.5 | |
Repurchases of Common Stock | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (0.1) | | | (54.0) | | | (54.0) | |
Stock-based compensation charges | | — | | | — | | | — | | | — | | | 114.8 | | | — | | | — | | | — | | | — | | | 114.8 | |
Adjustment upon adoption of new accounting standard | | — | | | — | | | — | | | — | | | — | | | 9.7 | | | — | | | — | | | — | | | 9.7 | |
Net income | | — | | | — | | | — | | | — | | | — | | | 461.1 | | | — | | | — | | | — | | | 461.1 | |
Other comprehensive income, net of tax | | — | | | — | | | — | | | — | | | — | | | — | | | 15.1 | | | — | | | — | | | 15.1 | |
Balance, March 31, 2019 | | 1.9 | | | — | | | 111.7 | | | 0.1 | | | 4,160.9 | | | 5,725.1 | | | 2.8 | | | (4.0) | | | (444.2) | | | 9,444.7 | |
Issuance of Common Stock for equity awards granted under long-term incentive plans | | — | | | — | | | 0.3 | | | — | | | 13.9 | | | — | | | — | | | — | | | — | | | 13.9 | |
Common Stock tendered upon exercise of stock options and vesting of restricted stock for employee tax obligations | | — | | | — | | | (0.1) | | | — | | | (29.7) | | | — | | | — | | | — | | | — | | | (29.7) | |
Issuance/distribution of Common Stock for 401(k) Savings Plan | | — | | | — | | | — | | | — | | | 9.3 | | | — | | | — | | | — | | | 2.4 | | | 11.7 | |
Stock-based compensation charges | | — | | | — | | | — | | | — | | | 109.2 | | | — | | | — | | | — | | | — | | | 109.2 | |
Net income | | — | | | — | | | — | | | — | | | — | | | 193.1 | | | — | | | — | | | — | | | 193.1 | |
Other comprehensive income, net of tax | | — | | | — | | | — | | | — | | | — | | | — | | | 13.0 | | | — | | | — | | | 13.0 | |
Balance, June 30, 2019 | | 1.9 | | | — | | | 111.9 | | | $ | 0.1 | | | $ | 4,263.6 | | | $ | 5,918.2 | | | $ | 15.8 | | | (4.0) | | | $ | (441.8) | | | $ | 9,755.9 | |
| | | | | | | | | | | | | | | | | | | | |
The accompanying notes are an integral part of the financial statements. | | | | | | | | | | | | | | | | | | | | |
REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(In millions)
| | | | | | | | | | | | | | |
| | Six Months Ended June 30, | | |
| | 2020 | | 2019 |
Cash flows from operating activities: | | | | |
Net income | | $ | |