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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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☒ | 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
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☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ________ to ________
Commission File No. 0-19731
GILEAD SCIENCES, INC.
(Exact Name of Registrant as Specified in Its Charter)
| | | | | |
Delaware | 94-3047598 |
(State or Other Jurisdiction of Incorporation or Organization) | (IRS Employer Identification No.) |
333 Lakeside Drive, Foster City, California 94404
(Address of principal executive offices) (Zip Code)
650-574-3000
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | | | | | | | |
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock, par value, $0.001 per share | | GILD | | The 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 x 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 x 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 x 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 x
Number of shares outstanding of the issuer’s common stock, par value $0.001 per share, as of October 31, 2022: 1,254,243,845
GILEAD SCIENCES, INC.
INDEX
We own or have rights to various trademarks and trade names used in our business, including the following: GILEAD®, GILEAD SCIENCES®, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, RANEXA®, SOVALDI®, STRIBILD®, SUNLENCA®, TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®. This report also refers to trademarks, service marks and trade names of other companies.
This Quarterly Report on Form 10-Q, including Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations and Part II, Item 1A. Risk Factors, contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. Words such as “expect,” “anticipate,” “target,” “goal,” “project,” “hope,” “intend,” “plan,” “believe,” “seek,” “estimate,” “continue,” “may,” “could,” “should,” “might,” “forecast” and variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, any statements other than statements of historical fact are forward-looking statements, including statements regarding overall trends; operating cost and revenue trends; liquidity and capital needs; plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital; collaboration and licensing arrangements; patent protection and estimated loss of exclusivity for our products and product candidates; ongoing litigation and investigation matters; statements regarding the anticipated future impact on our business of the coronavirus disease 2019 (“COVID-19”) and related public health measures; and other statements of expectations, beliefs, future plans and strategies, anticipated events or trends and similar expressions.
We have based these forward-looking statements on our current expectations about future events. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Our actual results may differ materially from those suggested by these forward-looking statements for various reasons, including those identified in Part II, Item 1A. Risk Factors. Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements included in this report are made only as of the date hereof unless otherwise specified. Except as required under federal securities laws and the rules and regulations of the U.S. Securities and Exchange Commission, we do not undertake, and specifically decline, any obligation to update any of these statements or to publicly announce the results of any revisions to any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise. In evaluating our business, you should carefully consider the risks described in Part II, Item 1A. Risk Factors of this Quarterly Report in addition to the other information in this Quarterly Report on Form 10-Q. Any of the risks contained herein could materially and adversely affect our business, results of operations and financial condition.
PART I. FINANCIAL INFORMATION
Item 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
| | | | | | | | | | | | | | |
(in millions, except per share amounts) | | September 30, 2022 | | December 31, 2021 |
Assets | | | | |
Current assets: | | | | |
Cash and cash equivalents | | $ | 4,699 | | | $ | 5,338 | |
Short-term marketable debt securities | | 961 | | | 1,182 | |
Accounts receivable, net | | 4,354 | | | 4,493 | |
Inventories | | 1,463 | | | 1,618 | |
Prepaid and other current assets | | 2,077 | | | 2,141 | |
Total current assets | | 13,554 | | | 14,772 | |
Property, plant and equipment, net | | 5,349 | | | 5,121 | |
Long-term marketable debt securities | | 1,282 | | | 1,309 | |
Intangible assets, net | | 29,440 | | | 33,455 | |
Goodwill | | 8,314 | | | 8,332 | |
Other long-term assets | | 4,618 | | | 4,963 | |
Total assets | | $ | 62,557 | | | $ | 67,952 | |
Liabilities and Stockholders’ Equity | | | | |
Current liabilities: | | | | |
Accounts payable | | $ | 614 | | | $ | 705 | |
Accrued government and other rebates | | 3,674 | | | 3,244 | |
Accrued and other current liabilities | | 3,865 | | | 6,145 | |
Current portion of long-term debt and other obligations, net | | 2,270 | | | 1,516 | |
Total current liabilities | | 10,423 | | | 11,610 | |
Long-term debt, net | | 22,953 | | | 25,179 | |
Long-term income taxes payable | | 3,982 | | | 4,767 | |
Deferred tax liability | | 3,036 | | | 4,356 | |
Other long-term obligations | | 1,106 | | | 976 | |
Commitments and contingencies (Note 10) | | | | |
Stockholders’ equity: | | | | |
Preferred stock, par value $0.001 per share; 5 shares authorized; none outstanding | | — | | | — | |
Common stock, par value $0.001 per share; 5,600 shares authorized; 1,254 shares issued and outstanding | | 1 | | | 1 | |
Additional paid-in capital | | 5,226 | | | 4,661 | |
Accumulated other comprehensive income | | 98 | | | 83 | |
Retained earnings | | 15,756 | | | 16,324 | |
Total Gilead stockholders’ equity | | 21,081 | | | 21,069 | |
Noncontrolling interest | | (24) | | | (5) | |
Total stockholders’ equity | | 21,057 | | | 21,064 | |
Total liabilities and stockholders’ equity | | $ | 62,557 | | | $ | 67,952 | |
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
(in millions, except per share amounts) | | 2022 | | 2021 | | 2022 | | 2021 |
Revenues: | | | | | | | | |
Product sales | | $ | 6,978 | | | $ | 7,356 | | | $ | 19,650 | | | $ | 19,848 | |
Royalty, contract and other revenues | | 64 | | | 65 | | | 242 | | | 213 | |
Total revenues | | 7,042 | | | 7,421 | | | 19,892 | | | 20,061 | |
Costs and expenses: | | | | | | | | |
Cost of goods sold | | 1,395 | | | 1,223 | | | 4,261 | | | 3,974 | |
Research and development expenses | | 1,149 | | | 1,101 | | | 3,429 | | | 3,243 | |
Acquired in-process research and development expenses | | 448 | | | 65 | | | 786 | | | 270 | |
In-process research and development impairment | | — | | | — | | | 2,700 | | | — | |
Selling, general and administrative expenses | | 1,213 | | | 1,190 | | | 3,653 | | | 3,596 | |
Total costs and expenses | | 4,205 | | | 3,579 | | | 14,829 | | | 11,083 | |
Income from operations | | 2,837 | | | 3,842 | | | 5,063 | | | 8,978 | |
Interest expense | | (229) | | | (250) | | | (709) | | | (763) | |
Other income (expense), net | | (176) | | | (154) | | | (571) | | | (696) | |
Income before income taxes | | 2,432 | | | 3,438 | | | 3,783 | | | 7,519 | |
Income tax expense | | (646) | | | (852) | | | (850) | | | (1,694) | |
Net income | | 1,786 | | | 2,586 | | | 2,933 | | | 5,825 | |
Net loss attributable to noncontrolling interest | | 3 | | | 6 | | | 19 | | | 18 | |
Net income attributable to Gilead | | $ | 1,789 | | | $ | 2,592 | | | $ | 2,952 | | | $ | 5,843 | |
Net income per share attributable to Gilead common stockholders – basic | | $ | 1.43 | | | $ | 2.06 | | | $ | 2.35 | | | $ | 4.65 | |
Shares used in per share calculation – basic | | 1,255 | | | 1,256 | | | 1,255 | | | 1,256 | |
Net income per share attributable to Gilead common stockholders – diluted | | $ | 1.42 | | | $ | 2.05 | | | $ | 2.34 | | | $ | 4.63 | |
Shares used in per share calculation – diluted | | 1,261 | | | 1,262 | | | 1,261 | | | 1,262 | |
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
(in millions) | | 2022 | | 2021 | | 2022 | | 2021 |
Net income | | $ | 1,786 | | | $ | 2,586 | | | $ | 2,933 | | | $ | 5,825 | |
Other comprehensive income: | | | | | | | | |
Net foreign currency translation loss, net of tax | | (81) | | | (20) | | | (102) | | | (15) | |
Available-for-sale debt securities: | | | | | | | | |
Net unrealized loss, net of tax | | (7) | | | — | | | (38) | | | (3) | |
Reclassifications to net income, net of tax | | — | | | — | | | 1 | | | — | |
Net change | | (7) | | | — | | | (37) | | | (3) | |
Cash flow hedges: | | | | | | | | |
Net unrealized gain, net of tax | | 140 | | | 37 | | | 254 | | | 92 | |
Reclassifications to net income, net of tax | | (41) | | | 18 | | | (100) | | | 60 | |
Net change | | 99 | | | 55 | | | 154 | | | 152 | |
Other comprehensive income | | 11 | | | 35 | | | 15 | | | 134 | |
Comprehensive income | | 1,797 | | | 2,621 | | | 2,948 | | | 5,959 | |
Comprehensive loss attributable to noncontrolling interest | | 3 | | | 6 | | | 19 | | | 18 | |
Comprehensive income attributable to Gilead | | $ | 1,800 | | | $ | 2,627 | | | $ | 2,967 | | | $ | 5,977 | |
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, 2022 |
(in millions, except per share amounts) | | Gilead Stockholders’ Equity | | Noncontrolling Interest | | Total Stockholders’ Equity |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Income (Loss) | | Retained Earnings | |
| Shares | | Amount | | |
Balance as of June 30, 2022 | | 1,254 | | | $ | 1 | | | $ | 5,031 | | | $ | 87 | | | $ | 15,117 | | | $ | (21) | | | $ | 20,215 | |
Net income (loss) | | — | | | — | | | — | | | — | | | 1,789 | | | (3) | | | 1,786 | |
Other comprehensive income, net of tax | | — | | | — | | | — | | | 11 | | | — | | | — | | | 11 | |
Issuances under employee stock purchase plan | | 2 | | | — | | | 30 | | | — | | | — | | | — | | | 30 | |
Issuances under equity incentive plans | | 2 | | | — | | | 6 | | | — | | | — | | | — | | | 6 | |
Stock-based compensation | | — | | | — | | | 170 | | | — | | | — | | | — | | | 170 | |
Repurchases of common stock | | (4) | | | — | | | (11) | | | — | | | (217) | | | — | | | (228) | |
Dividends declared ($0.73 per share) | | — | | | — | | | — | | | — | | | (933) | | | — | | | (933) | |
Balance as of September 30, 2022 | | 1,254 | | | $ | 1 | | | $ | 5,226 | | | $ | 98 | | | $ | 15,756 | | | $ | (24) | | | $ | 21,057 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Nine Months Ended September 30, 2022 |
(in millions, except per share amounts) | | Gilead Stockholders’ Equity | | Noncontrolling Interest | | Total Stockholders’ Equity |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Income (Loss) | | Retained Earnings | |
| Shares | | Amount | | |
Balance as of December 31, 2021 | | 1,254 | | | $ | 1 | | | $ | 4,661 | | | $ | 83 | | | $ | 16,324 | | | $ | (5) | | | $ | 21,064 | |
Net income (loss) | | — | | | — | | | — | | | — | | | 2,952 | | | (19) | | | 2,933 | |
Other comprehensive income, net of tax | | — | | | — | | | — | | | 15 | | | — | | | — | | | 15 | |
Issuances under employee stock purchase plan | | 3 | | | — | | | 103 | | | — | | | — | | | — | | | 103 | |
Issuances under equity incentive plans | | 9 | | | — | | | 30 | | | — | | | — | | | — | | | 30 | |
Stock-based compensation | | — | | | — | | | 465 | | | — | | | — | | | — | | | 465 | |
Repurchases of common stock | | (12) | | | — | | | (33) | | | — | | | (723) | | | — | | | (756) | |
Dividends declared ($2.19 per share) | | — | | | — | | | — | | | — | | | (2,797) | | | — | | | (2,797) | |
Balance as of September 30, 2022 | | 1,254 | | | $ | 1 | | | $ | 5,226 | | | $ | 98 | | | $ | 15,756 | | | $ | (24) | | | $ | 21,057 | |
See accompanying notes.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, 2021 |
(in millions, except per share amounts) | | Gilead Stockholders’ Equity | | Noncontrolling Interest | | Total Stockholders’ Equity |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Income (Loss) | | Retained Earnings | |
| Shares | | Amount | | |
Balance as of June 30, 2021 | | 1,254 | | | $ | 1 | | | $ | 4,271 | | | $ | 39 | | | $ | 15,392 | | | $ | 7 | | | $ | 19,710 | |
Net income (loss) | | — | | | — | | | — | | | — | | | 2,592 | | | (6) | | | 2,586 | |
Other comprehensive income, net of tax | | — | | | — | | | — | | | 35 | | | — | | | — | | | 35 | |
Issuances under employee stock purchase plan | | 1 | | | — | | | 35 | | | — | | | — | | | — | | | 35 | |
Issuances under equity incentive plans | | 3 | | | — | | | 22 | | | — | | | — | | | — | | | 22 | |
Stock-based compensation | | — | | | — | | | 171 | | | — | | | — | | | — | | | 171 | |
Repurchases of common stock | | (3) | | | — | | | (7) | | | — | | | (176) | | | — | | | (183) | |
Dividends declared ($0.71 per share) | | — | | | — | | | — | | | — | | | (905) | | | — | | | (905) | |
Balance as of September 30, 2021 | | 1,255 | | | $ | 1 | | | $ | 4,492 | | | $ | 74 | | | $ | 16,903 | | | $ | 1 | | | $ | 21,471 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Nine Months Ended September 30, 2021 |
(in millions, except per share amounts) | | Gilead Stockholders’ Equity | | Noncontrolling Interest | | Total Stockholders’ Equity |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive Income (Loss) | | Retained Earnings | |
| Shares | | Amount | | |
Balance as of December 31, 2020 | | 1,254 | | | $ | 1 | | | $ | 3,880 | | | $ | (60) | | | $ | 14,381 | | | $ | 19 | | | $ | 18,221 | |
Net income (loss) | | — | | | — | | | — | | | — | | | 5,843 | | | (18) | | | 5,825 | |
Other comprehensive income, net of tax | | — | | | — | | | — | | | 134 | | | — | | | — | | | 134 | |
Issuances under employee stock purchase plan | | 2 | | | — | | | 111 | | | — | | | — | | | — | | | 111 | |
Issuances under equity incentive plans | | 9 | | | — | | | 46 | | | — | | | — | | | — | | | 46 | |
Stock-based compensation | | — | | | — | | | 479 | | | — | | | — | | | — | | | 479 | |
Repurchases of common stock | | (10) | | | — | | | (24) | | | — | | | (607) | | | — | | | (631) | |
Dividends declared ($2.13 per share) | | — | | | — | | | — | | | — | | | (2,714) | | | — | | | (2,714) | |
Balance as of September 30, 2021 | | 1,255 | | | $ | 1 | | | $ | 4,492 | | | $ | 74 | | | $ | 16,903 | | | $ | 1 | | | $ | 21,471 | |
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
| | | | | | | | | | | | | | |
| | Nine Months Ended |
| | September 30, |
(in millions) | | 2022 | | 2021 |
Operating Activities: | | | | |
Net income | | $ | 2,933 | | | $ | 5,825 | |
Adjustments to reconcile net income to net cash provided by operating activities: | | | | |
Depreciation expense | | 240 | | | 239 | |
Amortization expense | | 1,335 | | | 1,276 | |
Stock-based compensation expense | | 463 | | | 476 | |
Acquired in-process research and development expenses | | 786 | | | 270 | |
In-process research and development impairment | | 2,700 | | | — | |
Deferred income taxes | | (1,214) | | | 243 |