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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
| | | | | | | | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 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 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 April 29, 2022: 1,254,313,448
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® (BULEVIRTIDE), HEPSERA®, JYSELECA® (FILGOTINIB), LETAIRIS®, ODEFSEY®, RANEXA®, SOVALDI®, STRIBILD®, 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.
PART I. FINANCIAL INFORMATION
Item 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
| | | | | | | | | | | | | | |
(in millions, except per share amounts) | | March 31, 2022 | | December 31, 2021 |
Assets | | | | |
Current assets: | | | | |
Cash and cash equivalents | | $ | 4,296 | | | $ | 5,338 | |
Short-term marketable debt securities | | 1,029 | | | 1,182 | |
Accounts receivable, net | | 3,787 | | | 4,493 | |
Inventories | | 1,482 | | | 1,618 | |
Prepaid and other current assets | | 2,035 | | | 2,141 | |
Total current assets | | 12,629 | | | 14,772 | |
Property, plant and equipment, net | | 5,253 | | | 5,121 | |
Long-term marketable debt securities | | 1,427 | | | 1,309 | |
Intangible assets, net | | 30,331 | | | 33,455 | |
Goodwill | | 8,314 | | | 8,332 | |
Other long-term assets | | 5,126 | | | 4,963 | |
Total assets | | $ | 63,080 | | | $ | 67,952 | |
Liabilities and Stockholders’ Equity | | | | |
Current liabilities: | | | | |
Accounts payable | | $ | 583 | | | $ | 705 | |
Accrued government and other rebates | | 3,450 | | | 3,244 | |
Accrued and other current liabilities | | 3,500 | | | 6,145 | |
Current portion of long-term debt and other obligations, net | | 1,025 | | | 1,516 | |
Total current liabilities | | 8,558 | | | 11,610 | |
Long-term debt, net | | 25,183 | | | 25,179 | |
Long-term income taxes payable | | 4,793 | | | 4,767 | |
Deferred tax liability | | 3,687 | | | 4,356 | |
Other long-term obligations | | 944 | | | 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; 1,255 and 1,254 shares issued and outstanding, respectively | | 1 | | | 1 | |
Additional paid-in capital | | 4,867 | | | 4,661 | |
Accumulated other comprehensive income | | 73 | | | 83 | |
Retained earnings | | 14,986 | | | 16,324 | |
Total Gilead stockholders’ equity | | 19,927 | | | 21,069 | |
Noncontrolling interest | | (12) | | | (5) | |
Total stockholders’ equity | | 19,915 | | | 21,064 | |
Total liabilities and stockholders’ equity | | $ | 63,080 | | | $ | 67,952 | |
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
| | | | | | | | | | | | | | |
| | Three Months Ended |
| | March 31, |
(in millions, except per share amounts) | | 2022 | | 2021 |
Revenues: | | | | |
Product sales | | $ | 6,534 | | | $ | 6,340 | |
Royalty, contract and other revenues | | 56 | | | 83 | |
Total revenues | | 6,590 | | | 6,423 | |
Costs and expenses: | | | | |
Cost of goods sold | | 1,424 | | | 1,361 | |
Research and development expenses | | 1,186 | | | 1,055 | |
In-process research and development impairment | | 2,700 | | | — | |
Acquired in-process research and development expenses | | — | | | 62 | |
Selling, general and administrative expenses | | 1,083 | | | 1,055 | |
Total costs and expenses | | 6,393 | | | 3,533 | |
Income from operations | | 197 | | | 2,890 | |
Interest expense | | (238) | | | (257) | |
Other income (expense), net | | (111) | | | (369) | |
Income (loss) before income taxes | | (152) | | | 2,264 | |
Income tax benefit (expense) | | 164 | | | (542) | |
Net income | | 12 | | | 1,722 | |
Net loss attributable to noncontrolling interest | | 7 | | | 7 | |
Net income attributable to Gilead | | $ | 19 | | | $ | 1,729 | |
Net income per share attributable to Gilead common stockholders - basic | | $ | 0.02 | | | $ | 1.38 | |
Shares used in per share calculation - basic | | 1,255 | | | 1,256 | |
Net income per share attributable to Gilead common stockholders - diluted | | $ | 0.02 | | | $ | 1.37 | |
Shares used in per share calculation - diluted | | 1,262 | | | 1,262 | |
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(unaudited)
| | | | | | | | | | | | | | |
| | Three Months Ended |
| | March 31, |
(in millions) | | 2022 | | 2021 |
Net income | | $ | 12 | | | $ | 1,722 | |
Other comprehensive income (loss): | | | | |
Net foreign currency translation gain, net of tax | | 5 | | | 10 | |
Available-for-sale debt securities: | | | | |
Net unrealized loss, net of tax | | (19) | | | (2) | |
Reclassifications to net income, net of tax | | — | | | — | |
Net change | | (19) | | | (2) | |
Cash flow hedges: | | | | |
Net unrealized gain, net of tax | | 24 | | | 68 | |
Reclassifications to net income, net of tax | | (20) | | | 22 | |
Net change | | 4 | | | 90 | |
Other comprehensive income (loss) | | (10) | | | 98 | |
Comprehensive income | | 2 | | | 1,820 | |
Comprehensive loss attributable to noncontrolling interest | | 7 | | | 7 | |
Comprehensive income attributable to Gilead | | $ | 9 | | | $ | 1,827 | |
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, 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) | | — | | | — | | | — | | | — | | | 19 | | | (7) | | | 12 | |
Other comprehensive loss, net of tax | | — | | | — | | | — | | | (10) | | | — | | | — | | | (10) | |
Issuances under employee stock purchase plan | | 1 | | | — | | | 73 | | | — | | | — | | | — | | | 73 | |
Issuances under equity incentive plans | | 7 | | | — | | | 21 | | | — | | | — | | | — | | | 21 | |
Stock-based compensation | | — | | | — | | | 131 | | | — | | | — | | | — | | | 131 | |
Repurchases of common stock | | (7) | | | — | | | (19) | | | — | | | (425) | | | — | | | (444) | |
Dividends declared ($0.73 per share) | | — | | | — | | | — | | | — | | | (932) | | | — | | | (932) | |
Balance as of March 31, 2022 | | 1,255 | | | $ | 1 | | | $ | 4,867 | | | $ | 73 | | | $ | 14,986 | | | $ | (12) | | | $ | 19,915 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, 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) | | — | | | — | | | — | | | — | | | 1,729 | | | (7) | | | 1,722 | |
Other comprehensive income, net of tax | | — | | | — | | | — | | | 98 | | | — | | | — | | | 98 | |
Issuances under employee stock purchase plan | | 1 | | | — | | | 76 | | | — | | | — | | | — | | | 76 | |
Issuances under equity incentive plans | | 5 | | | — | | | 12 | | | — | | | — | | | — | | | 12 | |
Stock-based compensation | | — | | | — | | | 140 | | | — | | | — | | | — | | | 140 | |
Repurchases of common stock | | (6) | | | — | | | (16) | | | — | | | (383) | | | — | | | (399) | |
Dividends declared ($0.71 per share) | | — | | | — | | | — | | | — | | | (906) | | | — | | | (906) | |
Balance as of March 31, 2021 | | 1,254 | | | $ | 1 | | | $ | 4,092 | | | $ | 38 | | | $ | 14,821 | | | $ | 12 | | | $ | 18,964 | |
See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
| | | | | | | | | | | | | | |
| | Three Months Ended |
| | March 31, |
(in millions) | | 2022 | | 2021 |
Operating Activities: | | | | |
Net income | | $ | 12 | | | $ | 1,722 | |
Adjustments to reconcile net income to net cash provided by operating activities: | | | | |
Depreciation expense | | 80 | | | 78 | |
Amortization expense | | 445 | | | 395 | |
Stock-based compensation expense | | 130 | | | 139 | |
Acquired in-process research and development expenses | | — | | | 62 | |
In-process research and development impairment | | 2,700 | | | — | |
Deferred income taxes | | (651) | | | 71 | |
Net loss from equity securities | | 96 | | | 351 | |
Other | | 190 | | | 201 | |
Changes in operating assets and liabilities: | | | | |
Accounts receivable, net | | 699 | | | 975 | |
Inventories | | 53 | | | (69) | |
Prepaid expenses and other | | (20) | | | (8) | |
Accounts payable | | (91) | | | (253) | |
Income taxes payable | | (146) | | | (316) | |
Accrued and other liabilities | | (1,657) | | | (738) | |
Net cash provided by operating activities | | 1,840 | | | 2,610 | |
Investing Activities: | | | | |
Purchases of marketable debt securities | | (613) | | | (931) | |
Proceeds from sales of marketable debt securities | | 119 | | | 60 | |
Proceeds from maturities of marketable debt securities | | 506 | | | 619 | |
Acquisitions, including in-process research and development, net of cash acquired | | (30) | | | (1,255) | |
Purchases of equity securities | | (28) | | | (279) | |
Capital expenditures | | (247) | | | (165) | |
Other | | (777) | | | (91) | |
Net cash used in investing activities | | (1,070) | | | (2,042) | |
Financing Activities: | | | | |
Proceeds from issuances of common stock | | 94 | | | 88 | |
Repurchases of common stock | | (352) | | | (309) | |
Repayments of debt and other obligations | | (500) | | | (1,250) | |
Payments of dividends | | (945) | | | (917) | |
Other | | (91) | | | (89) | |
Net cash used in financing activities | | (1,794) | | | (2,477) | |
Effect of exchange rate changes on cash and cash equivalents | | (18) | | | (23) | |
Net change in cash and cash equivalents | | (1,042) | | | (1,932) | |
Cash and cash equivalents at beginning of period | | 5,338 | | | 5,997 | |
Cash and cash equivalents at end of period | | $ | 4,296 | | | $ | 4,065 | |
See accompanying notes.
GILEAD SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The financial statements include all adjustments consisting of normal recurring adjustments that the management of Gilead Sciences, Inc. (“Gilead,” “we,” “our” or “us”) believes are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results expected for the full fiscal year or for any subsequent interim period.
The accompanying Condensed Consolidated Financial Statements include the accounts of Gilead, our wholly-owned subsidiaries and certain variable interest entities for which we are the primary beneficiary. All intercompany transactions have been eliminated. For consolidated entities where we own or are exposed to less than 100% of the economics, we record net income or loss attributable to noncontrolling interests in our Condensed Consolidated Statements of Income equal to the percentage of the economic or ownership interest retained in such entities by the respective noncontrolling parties.
We assess at the inception of an arrangement with another entity whether the relationship results in it being a variable interest entity (“VIE”) and, if so, whether we are the primary beneficiary of the VIE. This assessment is based on our power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and our obligation to absorb losses or the right to receive benefits from the VIE that could potentially be significant to the VIE. We did not have any material VIEs as of March 31, 2022.
The accompanying Condensed Consolidated Financial Statements and related Notes to Condensed Consolidated Financial Statements should be read in conjunction with the audited Consolidated Financial Statements and the related notes thereto for the year ended December 31, 2021, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission. Certain amounts and percentages in these Condensed Consolidated Financial Statements and accompanying notes may not sum or recalculate due to rounding.
Segment Information
We have one operating segment, which primarily focuses on the discovery, development and commercialization of innovative medicines in areas of unmet medical need. Our Chief Executive Officer, as the chief operating decision-maker (“CODM”), manages and allocates resources to the operations of our company on an entity-wide basis. Managing and allocating resources on an entity-wide basis enables our CODM to assess the overall level of resources available and how to best deploy these resources across functions and research and development (“R&D”) projects based on unmet medical need and, as necessary, reallocate resources among our internal R&D portfolio and external opportunities to best support the long-term growth of our business. See Note 2. Revenues for a summary of disaggregated revenues by product and geographic region.
Significant Accounting Policies, Estimates and Judgments
The preparation of these Condensed Consolidated Financial Statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. On an ongoing basis, we evaluate our significant accounting policies and estimates. We base our estimates on historical experience and on various market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Actual results may differ significantly from these estimates.
Concentrations of Risk
We are subject to credit risk from our portfolio of cash equivalents and marketable securities. Under our investment policy, we limit amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. We are not exposed to any significant concentrations of credit risk from these financial instruments. The goals of our investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk; liquidity of investments sufficient to meet cash flow requirements; and a competitive after-tax rate of return.
We are also subject to credit risk from our accounts receivable related to our product sales. Trade accounts receivable are recorded net of allowances for wholesaler chargebacks related to government and other programs, cash discounts for prompt payment and credit losses. Estimates of our allowance for credit losses consider a number of factors, including existing contractual payment terms, individual customer circumstances, historical payment patterns of our customers, a review of the local economic environment and its potential impact on expected future customer payment patterns and government funding and reimbursement practices. The majority of our trade accounts receivable arises from product sales in the United States and Europe.
2. REVENUES
Disaggregation of Revenues
The following table summarizes our Total revenues:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, 2022 | | Three Months Ended March 31, 2021 |
(in millions) | | U.S. | | Europe | | Other International | | Total | | U.S. | | Europe | | Other International | | Total |
Product sales: | | | | | | | | | | | | | | | | |
HIV | | | | | | | | | | | | | | | | |
Biktarvy | | $ | 1,706 | | | $ | 261 | | | $ | 184 | | | $ | 2,151 | | | $ | 1,465 | | | $ | 216 | | | $ | 143 | | | $ | 1,824 | |
Complera/Eviplera | | 17 | | | 24 | | | 4 | | | 44 | | | 25 | | | 34 | | | 4 | | | 63 | |
Descovy | | 311 | | | 32 | | | 31 | | | 374 | | | 282 | | | 42 | | | 35 | | | 359 | |
Genvoya | | 457 | | | 77 | | | 48 | | | 582 | | | 506 | | | 106 | | | 61 | | | 673 | |
Odefsey | | 232 | | | 96 | | | 11 | | | 339 | | | 240 | | | 113 | | | 14 | | | 367 | |
Stribild | | 22 | | | 8 | | | 3 | | | 32 | | | 31 | | | 11 | | | 4 | | | 46 | |
Truvada | | 28 | | | 4 | | | 6 | | | 38 | | | 119 | | | 7 | | | 9 | | | 135 | |
Revenue share - Symtuza(1) | | 86 | | | 44 | | | 3 | | | 132 | | | 89 | | | 44 | | | 2 | | | 135 | |
Other HIV(2) | | 5 | | | 4 | | | 5 | | | 14 | | | 29 | | | 5 | | | 14 | | | 48 | |
Total HIV | | 2,862 | | | 550 | | | 295 | | | 3,707 | | | 2,786 | | | 578 | | | 286 | | | 3,650 | |
| | | | | | | | | | | | | | | | |
Veklury | | 801 | | | 304 | | | 430 | | | 1,535 | | | 820 | | | 388 | | | 248 | | | 1,456 | |
Hepatitis C virus (“HCV”) | | | | | | | | | | | | | | | | |
Ledipasvir/Sofosbuvir(3) | | 13 | | | 4 | | | 18 | | | 35 | | | 19 | | | 16 | | | 21 | | | 56 | |
Sofosbuvir/Velpatasvir(4) | | 162 | | | 83 | | | 85 | | | 330 | | | 214 | | | 75 | | | 92 | | | 381 | |
Other HCV(5) | | 24 | | | 8 | | | 2 | | | 34 | | | 25 | | | 44 | | | 4 | | | 73 | |
Total HCV | | 199 | | | 95 | | | 105 | | | 399 | | | 258 | | | 135 | | | 117 | | | 510 | |
Hepatitis B virus (“HBV”) / Hepatitis delta virus (“HDV”) | | | | | | | | | | | | | | | | |
Vemlidy | | 80 | | | 9 | | | 111 | | | 200 | | | 77 | | | 8 | | | 96 | | | 181 | |
Viread | | — | | | 6 | | | 17 | | | 23 | | | 4 | | | 7 | | | 20 | | | 31 | |
Other HBV/HDV(6) | | — | | | 13 | | | — | | | 13 | | | — | | | 8 | | | — | | | 8 | |
Total HBV/HDV | | 80 | | | 28 | | | 128 | | | 235 | | | 81 | | | 23 | | | 116 | | | 220 | |
| | | | | | | | | | | | | | | | |
Cell therapy | | | | | | | | | | | | | | | | |
Tecartus | | 47 | | | 15 | | | 1 | | | 63 | | | 27 | | | 4 | | | — | | | 31 | |
Yescarta | | 125 | | | 77 | | | 9 | | | 211 | | | 92 | | | 61 | | | 7 | | | 160 | |
Total cell therapy | | 172 | | | 92 | | | 10 | | | 274 | | | 119 | | | 65 | | | 7 | | | 191 | |
| | | | | | | | | | | | | | | | |
Trodelvy | | 119 | | | 25 | | | 2 | | | 146 | | | 72 | | | — | | | — | | | 72 | |
Other | | | | | | | | | | | | | | | | |
AmBisome | | 25 | | | 66 | | | 53 | | | 144 | | | 12 | | | 66 | | | 43 | | | 121 | |
Letairis | | 43 | | | — | | | — | | | 43 | | | 54 | | | — | | | — | | | 54 | |
Other(7) | | 26 | | | 15 | | | 9 | | | 50 | | | 38 | | | 20 | | | 8 | | | 66 | |
Total other | | 94 | | | 81 | | | 62 | | | 236 | | | 104 | | | 86 | | | 51 | | | 241 | |
Total product sales | | 4,329 | | | 1,174 | | | 1,031 | | | 6,534 | | | 4,240 | | | |