Q2'13 Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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ý | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| For the quarterly period ended June 30, 2013 |
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)
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Delaware | 94-3047598 |
(State or Other Jurisdiction of Incorporation or Organization) | (IRS Employer Identification No.) |
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333 Lakeside Drive, Foster City, California | 94404 |
(Address of principal executive offices) | (Zip Code) |
650-574-3000
Registrant’s Telephone Number, Including Area Code
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 ý No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes ý No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ý Accelerated filer ¨ Non-accelerated filer ¨ Smaller reporting company ¨
(Do not check if a smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No ý
Number of shares outstanding of the issuer’s common stock, par value $0.001 per share, as of July 19, 2013: 1,530,626,021
GILEAD SCIENCES, INC.
INDEX
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PART I. | | | |
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| Item 1. | | | |
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| Item 2. | | | |
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| Item 3. | | | |
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| Item 4. | | | |
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PART II. | | | |
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| Item 1. | | | |
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| Item 1A. | | | |
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| Item 2. | | | |
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| Item 3. | | | |
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| Item 4. | | | |
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| Item 5. | | | |
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| Item 6. | | | |
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We own or have rights to various trademarks, copyrights and trade names used in our business, including the following: GILEAD®, GILEAD SCIENCES®, STRIBILD®, COMPLERA®, EVIPLERA®, TRUVADA®, VIREAD®, HEPSERA®, AMBISOME®, EMTRIVA®, VISTIDE®, LETAIRIS®, VOLIBRIS®, RANEXA®, CAYSTON® and RAPISCAN®. ATRIPLA® is a registered trademark belonging to Bristol-Myers Squibb & Gilead Sciences, LLC. LEXISCAN® is a registered trademark belonging to Astellas U.S. LLC. MACUGEN® is a registered trademark belonging to Eyetech, Inc. SUSTIVA® is a registered trademark of Bristol-Myers Squibb Pharma Company. TAMIFLU® is a registered trademark belonging to Hoffmann-La Roche Inc. This report also includes other trademarks, service marks and trade names of other companies.
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PART I. | FINANCIAL INFORMATION |
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ITEM I. | CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
|
| | | | | | | |
| June 30, 2013 | | December 31, 2012 |
| (unaudited) | | |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 2,202,176 |
| | $ | 1,803,694 |
|
Short-term marketable securities | 85,194 |
| | 58,556 |
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Accounts receivable, net | 1,895,913 |
| | 1,751,388 |
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Inventories | 1,935,147 |
| | 1,744,982 |
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Deferred tax assets | 224,429 |
| | 262,641 |
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Prepaid taxes | 395,494 |
| | 348,420 |
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Prepaid expenses | 157,821 |
| | 102,364 |
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Other current assets | 176,355 |
| | 84,302 |
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Total current assets | 7,072,529 |
| | 6,156,347 |
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Property, plant and equipment, net | 1,135,993 |
| | 1,100,259 |
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Long-term portion of prepaid royalties | 183,657 |
| | 175,790 |
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Long-term deferred tax assets | 155,667 |
| | 131,107 |
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Long-term marketable securities | 688,428 |
| | 719,836 |
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Intangible assets, net | 12,056,002 |
| | 11,736,393 |
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Goodwill | 1,188,157 |
| | 1,060,919 |
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Other long-term assets | 143,941 |
| | 159,187 |
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Total assets | $ | 22,624,374 |
| | $ | 21,239,838 |
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| | |
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Liabilities and Stockholders’ Equity | |
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Current liabilities: | |
| | |
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Accounts payable | $ | 1,390,641 |
| | $ | 1,327,339 |
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Accrued government rebates | 879,112 |
| | 745,148 |
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Accrued compensation and employee benefits | 197,668 |
| | 236,716 |
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Income taxes payable | 37,974 |
| | 13,403 |
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Other accrued liabilities | 831,399 |
| | 674,762 |
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Deferred revenues | 112,119 |
| | 103,162 |
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Current portion of long-term debt and other obligations, net | 1,488,225 |
| | 1,169,490 |
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Total current liabilities | 4,937,138 |
| | 4,270,020 |
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Long-term deferred revenues | 28,768 |
| | 20,532 |
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Long-term debt, net | 5,849,552 |
| | 7,054,555 |
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Long-term income taxes payable | 122,590 |
| | 115,822 |
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Long-term deferred tax liabilities | 118,315 |
| | 10,190 |
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Other long-term obligations | 224,627 |
| | 217,850 |
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Commitments and contingencies (Note 10) | |
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Stockholders’ equity: | |
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Preferred stock, par value $0.001 per share; 5,000 shares authorized; none outstanding | — |
| | — |
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Common stock, par value $0.001 per share; 5,600,000 shares authorized; 1,528,890 and 1,519,163 shares issued and outstanding | 765 |
| | 760 |
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Additional paid-in capital | 5,995,025 |
| | 5,649,850 |
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Accumulated other comprehensive income (loss) | 30,371 |
| | (45,615 | ) |
Retained earnings | 5,065,839 |
| | 3,704,744 |
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Total Gilead stockholders’ equity | 11,092,000 |
| | 9,309,739 |
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Noncontrolling interest | 251,384 |
| | 241,130 |
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Total stockholders’ equity | 11,343,384 |
| | 9,550,869 |
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Total liabilities and stockholders’ equity | $ | 22,624,374 |
| | $ | 21,239,838 |
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See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
(in thousands, except per share amounts)
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| | | | | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended |
| | June 30, | | June 30, |
| | 2013 | | 2012 | | 2013 | | 2012 |
Revenues: | | | | | | | | |
Product sales | | $ | 2,657,285 |
| | $ | 2,321,240 |
| | $ | 5,050,853 |
| | $ | 4,529,582 |
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Royalty revenues | | 106,514 |
| | 81,106 |
| | 240,921 |
| | 152,211 |
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Contract and other revenues | | 3,595 |
| | 2,840 |
| | 7,255 |
| | 5,842 |
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Total revenues | | 2,767,394 |
| | 2,405,186 |
| | 5,299,029 |
| | 4,687,635 |
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Costs and expenses: | | | | | | | | |
Cost of goods sold | | 684,663 |
| | 617,345 |
| | 1,319,111 |
| | 1,198,276 |
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Research and development | | 523,902 |
| | 396,244 |
| | 1,021,534 |
| | 854,455 |
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Selling, general and administrative | | 404,991 |
| | 332,505 |
| | 779,287 |
| | 775,626 |
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Total costs and expenses | | 1,613,556 |
| | 1,346,094 |
| | 3,119,932 |
| | 2,828,357 |
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Income from operations | | 1,153,838 |
| | 1,059,092 |
| | 2,179,097 |
| | 1,859,278 |
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Interest expense | | (78,008 | ) | | (88,418 | ) | | (159,795 | ) | | (185,688 | ) |
Other income (expense), net | | (231 | ) | | (1,075 | ) | | (3,555 | ) | | (35,160 | ) |
Income before provision for income taxes | | 1,075,599 |
| | 969,599 |
| | 2,015,747 |
| | 1,638,430 |
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Provision for income taxes | | 307,981 |
| | 263,525 |
| | 530,419 |
| | 494,825 |
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Net income | | 767,618 |
| | 706,074 |
| | 1,485,328 |
| | 1,143,605 |
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Net loss attributable to noncontrolling interest | | 4,987 |
| | 5,490 |
| | 9,463 |
| | 9,915 |
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Net income attributable to Gilead | | $ | 772,605 |
| | $ | 711,564 |
| | $ | 1,494,791 |
| | $ | 1,153,520 |
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Net income per share attributable to Gilead common stockholders—basic | | $ | 0.51 |
| | $ | 0.47 |
| | $ | 0.98 |
| | $ | 0.76 |
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Shares used in per share calculation—basic | | 1,526,945 |
| | 1,513,902 |
| | 1,524,174 |
| | 1,513,238 |
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Net income per share attributable to Gilead common stockholders—diluted | | $ | 0.46 |
| | $ | 0.46 |
| | $ | 0.89 |
| | $ | 0.74 |
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Shares used in per share calculation—diluted | | 1,694,577 |
| | 1,561,012 |
| | 1,683,269 |
| | 1,558,492 |
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See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(unaudited)
(in thousands)
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| | | | | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended |
| | June 30, | | June 30, |
| | 2013 | | 2012 | | 2013 | | 2012 |
Net income | | $ | 767,618 |
| | $ | 706,074 |
| | $ | 1,485,328 |
| | $ | 1,143,605 |
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Other comprehensive income: | | | | | | | | |
Net foreign currency translation gain (loss), net of tax | | 11,730 |
| | (2,642 | ) | | 2,774 |
| | 2,256 |
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Available-for-sale securities: | | | | | | | | |
Net unrealized gain (loss), net of tax impact of $1,144, $(79), $128 and $188 | | (2,019 | ) | | 134 |
| | (234 | ) | | (329 | ) |
Reclassifications to net income, net of tax impact of $(32), $(29), $(41) and $(547) | | (58 | ) | | (50 | ) | | (75 | ) | | 30,549 |
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Net change | | (2,077 | ) | | 84 |
| | (309 | ) | | 30,220 |
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Cash flow hedges: | | | | | | | | |
Net unrealized gain, net of tax impact of $(1,730), $(4,074), $(3,579) and $(2,318) | | 5,022 |
| | 107,855 |
| | 79,082 |
| | 58,993 |
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Reclassifications to net income, net of tax impact of $(241), $(548), $(252) and $(994) | | (5,110 | ) | | (14,511 | ) | | (5,561 | ) | | (25,292 | ) |
Net change | | (88 | ) | | 93,344 |
| | 73,521 |
| | 33,701 |
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Other comprehensive income | | 9,565 |
| | 90,786 |
| | 75,986 |
| | 66,177 |
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Comprehensive income | | 777,183 |
| | 796,860 |
| | 1,561,314 |
| | 1,209,782 |
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Comprehensive loss attributable to noncontrolling interest | | 4,987 |
| | 5,490 |
| | 9,463 |
| | 9,915 |
|
Comprehensive income attributable to Gilead | | $ | 782,170 |
| | $ | 802,350 |
| | $ | 1,570,777 |
| | $ | 1,219,697 |
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See accompanying notes.
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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| | | | | | | | |
| | Six Months Ended |
| | June 30, |
| | 2013 | | 2012 |
Operating Activities: | | | | |
Net income | | $ | 1,485,328 |
| | $ | 1,143,605 |
|
Adjustments to reconcile net income to net cash provided by operating activities: | | | | |
Depreciation expense | | 50,091 |
| | 39,937 |
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Amortization expense | | 97,412 |
| | 93,642 |
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Stock-based compensation expense | | 117,720 |
| | 97,134 |
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Excess tax benefits from stock-based compensation | | (89,151 | ) | | (35,439 | ) |
Tax benefits from employee stock plans | | 89,025 |
| | 30,804 |
|
Deferred income taxes | | 9,974 |
| | 21,966 |
|
Other | | 26,655 |
| | 1,064 |
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Changes in operating assets and liabilities: | | | | |
Accounts receivable, net | | (181,266 | ) | | 180,167 |
|
Inventories | | (200,856 | ) | | (213,190 | ) |
Prepaid expenses and other assets | | (153,801 | ) | | (32,329 | ) |
Accounts payable | | 64,831 |
| | 230,614 |
|
Income taxes payable | | 42,321 |
| | (102,093 | ) |
Accrued liabilities | | 249,635 |
| | 276,944 |
|
Deferred revenues | | 17,187 |
| | 10,794 |
|
Net cash provided by operating activities | | 1,625,105 |
| | 1,743,620 |
|
| | | | |
Investing Activities: | | | | |
Purchases of marketable securities | | (199,357 | ) | | (607,078 | ) |
Proceeds from sales of marketable securities | | 159,828 |
| | 63,274 |
|
Proceeds from maturities of marketable securities | | 39,571 |
| | 2,951 |
|
Purchases of other investments | | — |
| | (25,000 | ) |
Acquisitions, net of cash acquired | | (378,645 | ) | | (10,751,636 | ) |
Capital expenditures | | (84,130 | ) | | (60,591 | ) |
Net cash used in investing activities | | (462,733 | ) | | (11,378,080 | ) |
| | | | |
Financing Activities: | | | | |
Proceeds from debt financing, net of issuance costs | | — |
| | 2,144,733 |
|
Proceeds from convertible note hedges | | 1,205,956 |
| | — |
|
Proceeds from issuances of common stock | | 146,342 |
| | 201,791 |
|
Repurchases of common stock | | (82,239 | ) | | (261,791 | ) |
Repayments of debt financing | | (2,135,537 | ) | | (700,000 | ) |
Repayments of other long-term obligations | | (38 | ) | | (2,151 | ) |
Excess tax benefits from stock-based compensation | | 89,151 |
| | 35,439 |
|
Contributions from (distributions to) noncontrolling interest | | 19,716 |
| | (37,310 | ) |
Net cash provided by (used in) financing activities | | (756,649 | ) | | 1,380,711 |
|
Effect of exchange rate changes on cash | | (7,241 | ) | | (4,528 | ) |
Net change in cash and cash equivalents | | 398,482 |
| | (8,258,277 | ) |
Cash and cash equivalents at beginning of period | | 1,803,694 |
| | 9,883,777 |
|
Cash and cash equivalents at end of period | | $ | 2,202,176 |
| | $ | 1,625,500 |
|
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See accompanying notes.
GILEAD SCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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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 only of normal recurring adjustments) that the management of Gilead Sciences, Inc. (Gilead, we 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 Consolidated Financial Statements include the accounts of Gilead, our wholly-owned subsidiaries and our joint ventures with Bristol-Myers Squibb Company (BMS), for which we are the primary beneficiary. We record a noncontrolling interest in our Condensed Consolidated Financial Statements to reflect BMS’s interest in the joint ventures. All intercompany transactions have been eliminated. The Condensed Consolidated Financial Statements include the results of companies acquired by us from the date of each acquisition for the applicable reporting periods.
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, 2012, included in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission.
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 and expenses, and related disclosures. On an ongoing basis, management evaluates its significant accounting policies or 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. Actual results may differ significantly from these estimates.
Net Income Per Share Attributable to Gilead Common Stockholders
Basic net income per share attributable to Gilead common stockholders is calculated based on the weighted-average number of shares of our common stock outstanding during the period. Diluted net income per share attributable to Gilead common stockholders is calculated based on the weighted-average number of shares of our common stock outstanding and other dilutive securities outstanding during the period. The potential dilutive shares of our common stock resulting from the assumed exercise of outstanding stock options, performance shares and the assumed exercise of warrants relating to the convertible senior notes due in May 2013 (May 2013 Notes), May 2014 (May 2014 Notes) and May 2016 (May 2016 Notes) (collectively, the Convertible Notes) are determined under the treasury stock method.
Because the principal amount of the Convertible Notes will be settled in cash, only the conversion spread relating to the Convertible Notes is included in our calculation of diluted net income per share attributable to Gilead common stockholders. Our common stock resulting from the assumed settlement of the conversion spread of the Convertible Notes has a dilutive effect when the average market price of our common stock during the period exceeds the conversion price of $19.05 for the May 2013 Notes, $22.54 for the May 2014 Notes and $22.71 for the May 2016 Notes. Warrants relating to the Convertible Notes have a dilutive effect when the average market price of our common stock during the period exceeds the warrants’ exercise price of $26.95 for the May 2013 Notes, $28.38 for the May 2014 Notes and $30.05 for the May 2016 Notes.
Our May 2013 Notes matured and as a result, we have only included their impact for the period they were outstanding on our net income per share calculations for the three and six months ended June 30, 2013. Warrants related to our May 2013 Notes remained outstanding at June 30, 2013 and we have included their full impact on our net income per share calculations for the three and six months ended June 30, 2013. The warrants related to our May 2013 Notes will expire in August 2013.
Stock options to purchase 1.0 million weighted-average shares of our common stock were outstanding during the three months ended June 30, 2013, 1.7 million shares during the six months ended June 30, 2013 and 9.2 million shares during both the three and six months ended June 30, 2012. These shares were not included in the computation of diluted net income per share attributable to Gilead common stockholders because their effect was antidilutive.
The following table is a reconciliation of the numerator and denominator used in the calculation of basic and diluted net income per share attributable to Gilead common stockholders (in thousands):
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| | Three Months Ended | | Six Months Ended |
| | June 30, | | June 30, |
| | 2013 | | 2012 | | 2013 | | 2012 |
Numerator: | | | | | | | | |
Net income attributable to Gilead | | $ | 772,605 |
| | $ | 711,564 |
| | $ | 1,494,791 |
| | $ | 1,153,520 |
|
Denominator: | | | | | | | | |
Weighted-average shares of common stock outstanding used in the calculation of basic net income per share attributable to Gilead common stockholders | | 1,526,945 |
| | 1,513,902 |
| | 1,524,174 |
| | 1,513,238 |
|
Effect of dilutive securities: | | | | | | | | |
Stock options and equivalents | | 38,512 |
| | 28,772 |
| | 38,437 |
| | 29,764 |
|
Conversion spread related to the May 2013 Notes | | 3,592 |
| | 8,058 |
| | 7,519 |
| | 7,470 |
|
Conversion spread related to the May 2014 Notes | | 29,627 |
| | 5,344 |
| | 28,075 |
| | 4,214 |
|
Conversion spread related to the May 2016 Notes | | 30,850 |
| | 4,936 |
| | 28,418 |
| | 3,806 |
|
Warrants related to the Convertible Notes | | 65,051 |
| | — |
| | 56,646 |
| | — |
|
Weighted-average shares of common stock outstanding used in the calculation of diluted net income per share attributable to Gilead common stockholders | | 1,694,577 |
| | 1,561,012 |
| | 1,683,269 |
| | 1,558,492 |
|
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. The majority of our trade accounts receivable arises from product sales in the United States and Europe.
As of June 30, 2013, our accounts receivable in Southern Europe, specifically Greece, Italy, Portugal and Spain, totaled approximately $891.2 million, of which $383.8 million were greater than 120 days past due and $135.4 million were greater than 365 days past due. To date, we have not experienced significant losses with respect to the collection of our accounts receivable. We believe that our allowance for doubtful accounts was adequate at June 30, 2013.
Recent Accounting Pronouncements
In February 2013, the FASB also issued an update to the existing standard for liabilities. The update provides guidance for the recognition, measurement and disclosure of obligations resulting from joint and several liability arrangements. For obligations for which the total amount is fixed at the reporting date, an entity will be required to measure those obligations as the sum of the amount the reporting entity agreed to pay on the basis of its arrangement among its co-obligors and any additional amount the reporting entity expects to pay on behalf of its co-obligors. Such entities will also be required to disclose the nature, amount and other significant information about the obligations. This guidance will become effective for us beginning in the first quarter of 2014. We are evaluating the financial statement impact of this guidance. Currently, we do not expect that adopting this update will have a material impact on our Consolidated Financial Statements.
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2. | FAIR VALUE MEASUREMENTS |
We determine the fair value of financial and non-financial assets and liabilities using the fair value hierarchy, which establishes three levels of inputs that may be used to measure fair value, as follows:
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• | Level 1 inputs which include quoted prices in active markets for identical assets or liabilities; |
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• | Level 2 inputs which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For our marketable securities, we review trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and |
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• | Level 3 inputs which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation. |
Our financial instruments consist principally of cash and cash equivalents, marketable securities, accounts receivable, foreign currency exchange forward and option contracts, accounts payable and short-term and long-term debt. Cash and cash equivalents, marketable securities and foreign currency exchange contracts that hedge accounts receivable and forecasted sales are reported at their respective fair values on our Condensed Consolidated Balance Sheets. Short-term and long-term debt are reported at their amortized cost on our Condensed Consolidated Balance Sheets. The remaining financial instruments are reported on our Condensed Consolidated Balances Sheets at amounts that approximate current fair values.
The fair values of our Convertible Notes and senior unsecured notes were determined using Level 2 inputs based on their quoted market values. The following table summarizes the carrying values and fair values of the Convertible Notes and senior unsecured notes (in thousands):
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| | | | | | | | | | | | | | | | | | |
| | | | June 30, 2013 | | December 31, 2012 |
Type of Borrowing | | Description | | Carrying Value | | Fair Value | | Carrying Value | | Fair Value |
Convertible Senior | | May 2013 Notes | | $ | — |
| | $ | — |
| | $ | 419,433 |
| | $ | 815,297 |
|
Convertible Senior | | May 2014 Notes | | 888,170 |
| | 2,072,267 |
| | 1,210,213 |
| | 2,040,363 |
|
Convertible Senior | | May 2016 Notes | | 1,162,018 |
| | 2,808,435 |
| | 1,157,692 |
| | 2,110,938 |
|
Senior Unsecured | | April 2021 Notes | | 993,352 |
| | 1,080,040 |
| | 992,923 |
| | 1,146,990 |
|
Senior Unsecured | | December 2014 Notes | | 749,552 |
| | 766,320 |
| | 749,394 |
| | 772,650 |
|
Senior Unsecured | | December 2016 Notes | | 699,210 |
| | 739,935 |
| | 699,095 |
| | 748,902 |
|
Senior Unsecured | | December 2021 Notes | | 1,247,573 |
| | 1,336,325 |
| | 1,247,428 |
| | 1,420,725 |
|
Senior Unsecured | | December 2041 Notes | | 997,847 |
| | 1,105,890 |
| | 997,810 |
| | 1,252,090 |
|
The following table summarizes, for assets or liabilities recorded at fair value, the respective fair value and the classification by level of input within the fair value hierarchy defined above (in thousands): |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| June 30, 2013 | | December 31, 2012 |
| Level 1 | | Level 2 | | Level 3 | | Total | | Level 1 | | Level 2 | | Level 3 | | Total |
Assets: | | | | | | | | | | | | | | | |
Debt securities: | | | | | | | | | | | | | | | |
U.S. Treasury securities | $ | 161,219 |
| | $ | — |
| | $ | — |
| | $ | 161,219 |
| | $ | 81,903 |
| | $ | — |
| | $ | — |
| | $ | 81,903 |
|
Money market funds | 1,857,134 |
| | — |
| | — |
| | 1,857,134 |
| | 1,416,355 |
| | — |
| | — |
| | 1,416,355 |
|
U.S. government agencies securities | — |
| | 155,317 |
| | — |
| | 155,317 |
| | — |
| | 248,952 |
| | — |
| | 248,952 |
|
Municipal debt securities | — |
| | 12,043 |
| | — |
| | 12,043 |
| | — |
| | 12,088 |
| | — |
| | 12,088 |
|
Corporate debt securities | — |
| | 370,087 |
| | — |
| | 370,087 |
| | — |
| | 352,718 |
| | — |
| | 352,718 |
|
Residential mortgage and asset-backed securities | — |
| | 79,955 |
| | — |
| | 79,955 |
| | — |
| | 82,732 |
| | — |
| | 82,732 |
|
Total debt securities | 2,018,353 |
| | 617,402 |
| | — |
| | 2,635,755 |
| | 1,498,258 |
| | 696,490 |
| | — |
| | 2,194,748 |
|
Derivatives | — |
| | 41,429 |
| | — |
| | 41,429 |
| | — |
| | 14,823 |
| | — |
| | 14,823 |
|
| $ | 2,018,353 |
| | $ | 658,831 |
| | $ | — |
| | $ | 2,677,184 |
| | $ | 1,498,258 |
| | $ | 711,313 |
| | $ | — |
| | $ | 2,209,571 |
|
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
|
Liabilities: | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
|
Contingent consideration | $ | — |
| | $ | — |
| | $ | 222,502 |
| | $ | 222,502 |
| | $ | — |
| | $ | — |
| | $ | 205,060 |
| | $ | 205,060 |
|
Derivatives | — |
| | 13,875 |
| | — |
| | 13,875 |
| | — |
| | 65,248 |
| | — |
| | 65,248 |
|
| $ | — |
| | $ | 13,875 |
| | $ | 222,502 |
| | $ | 236,377 |
| | $ | — |
| | $ | 65,248 |
| | $ | 205,060 |
| | $ | 270,308 |
|
Level 2 Inputs
We estimate the fair values of our government related debt, corporate debt, residential mortgage and asset-backed securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income- and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities; issuer credit spreads; benchmark securities; prepayment/default projections based on historical data; and other observable inputs.
Substantially all of our foreign currency derivatives contracts have maturities primarily over an 18 month time horizon and all are with counterparties that have a minimum credit rating of A- or equivalent by Standard & Poor's, Moody's Investors Service, Inc. or Fitch, Inc. We estimate the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that utilizes an income-based industry standard valuation model for which all significant inputs are observable, either directly or indirectly. These inputs include foreign currency rates, London Interbank Offered Rates (LIBOR) and swap rates. These inputs, where applicable, are at commonly quoted intervals.
Level 3 Inputs
As of June 30, 2013 and December 31, 2012, the only assets or liabilities that were measured using Level 3 inputs were contingent consideration liabilities. During 2012, we held auction rate securities and Greek government bonds which were measured at fair value using Level 3 inputs. Our policy is to recognize transfers into or out of Level 3 classification as of the actual date of the event or change in circumstances that caused the transfer.
Auction Rate Securities
During the third quarter of 2012, we sold our remaining portfolio of auction rate securities and as a result of the sale, we received total proceeds of $37.3 million which resulted in a $3.8 million loss that was recognized in other income (expense), net on our Condensed Consolidated Statements of Income.
The underlying assets of our auction rate securities consisted of student loans. Although auction rate securities would typically be measured using Level 2 inputs, the failure of auctions and the lack of market activity and liquidity experienced since the beginning of 2008 required that these securities be measured using Level 3 inputs. The fair value of our auction rate securities was determined using a discounted cash flow model that considered projected cash flows for the issuing trusts, underlying collateral and expected yields. Projected cash flows were estimated based on the underlying loan principal, bonds outstanding and payout formulas. The weighted-average life over which the cash flows were projected considered the collateral composition of the securities and related historical and projected prepayments.
Greek Government Bonds
During the first quarter of 2012, the Greek government restructured its sovereign debt which impacted all holders of Greek bonds. As a result, we recorded a $40.1 million loss related to the debt restructuring as part of other income (expense), net on our Condensed Consolidated Statements of Income and exchanged the Greek government-issued bonds for new securities, which we liquidated during the first quarter of 2012. We estimated the fair value of the Greek zero-coupon bonds using Level 3 inputs due to the then current lack of market activity and liquidity. The discount rates used in our fair value model for these bonds were based on credit default swap rates.
Contingent Consideration Liabilities
In connection with certain acquisitions, we may be required to pay future consideration that is contingent upon the achievement of specified development, regulatory approval or sales-based milestone events. We estimate the fair value of the contingent consideration liabilities on the acquisition date and each reporting period thereafter using a probability-weighted income approach, which reflects the probability and timing of future payments. This fair value measurement is based on significant Level 3 inputs such as the anticipated timelines and probability of achieving development, regulatory approval or sales-based milestone events and projected revenues. The resulting probability-weighted cash flows are discounted using credit-risk adjusted interest rates.
Each reporting period thereafter, we revalue these obligations by performing a review of the assumptions listed above and record increases or decreases in the fair value of these contingent consideration obligations in research and development (R&D) expenses within our Condensed Consolidated Statements of Income until such time that the related product candidate receives marketing approval. In the absence of any significant changes in key assumptions, the quarterly determination of fair values of these contingent consideration obligations would primarily reflect the passage of time.
Significant judgment is employed in determining Level 3 inputs and fair value measurements as of the acquisition date and for each subsequent period. Updates to assumptions could have a significant impact on our results of operations in any given period and actual results may differ from estimates. For example, significant increases in the probability of achieving a milestone or projected revenues would result in a significantly higher fair value measurement while significant decreases in the estimated probability of achieving a milestone or projected revenues would result in a significantly lower fair value measurement. Significant increases in the discount rate or in the anticipated timelines would result in a significantly lower fair value measurement while significant decreases in the discount rate or anticipated timelines would result in a significantly higher fair value measurement.
The potential contingent consideration payments required upon achievement of development or regulatory approval-based milestones related to our CGI Pharmaceuticals, Inc. and Calistoga Pharmaceuticals, Inc. acquisitions range from no payment if none of the milestones are achieved to an estimated maximum of $254.0 million (undiscounted), of which we had accrued $173.8 million as of June 30, 2013 and $159.3 million as of December 31, 2012. The remainder of the contingent consideration liabilities accrual as of June 30, 2013 and December 31, 2012 relates to potential future payments resulting from the acquisition of Arresto Biosciences, Inc. for royalty obligations on future sales once specified sales-based milestones are achieved.
The following table provides a rollforward of our contingent consideration liabilities, which are recorded as part of other long-term obligations in our Condensed Consolidated Balance Sheets (in thousands):
|
| | | | |
Balance at December 31, 2012 | | $ | 205,060 |
|
Additions from new acquisitions | | — |
|
Net changes in valuation | | 17,442 |
|
Balance at June 30, 2013 | | $ | 222,502 |
|
| |
3. | AVAILABLE-FOR-SALE SECURITIES |
The following table is a summary of available-for-sale debt securities recorded in cash and cash equivalents or marketable securities in our Condensed Consolidated Balance Sheets (in thousands):
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | June 30, 2013 | | December 31, 2012 |
| | Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Estimated Fair Value | | Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Estimated Fair Value |
| | | | | | | | | | | | | | | | |
Debt securities: | | | | | | | | | | | | | | | | |
U.S. Treasury securities | | $ | 161,523 |
| | $ | 77 |
| | $ | (381 | ) | | $ | 161,219 |
| | $ | 81,752 |
| | $ | 151 |
| | $ | — |
| | $ | 81,903 |
|
Money market funds | | 1,857,134 |
| | — |
| | — |
| | 1,857,134 |
| | 1,416,356 |
| | — |
| | — |
| | 1,416,356 |
|
U.S. government agencies securities | | 155,274 |
| | 184 |
| | (141 | ) | | 155,317 |
| | 248,595 |
| | 386 |
| | (29 | ) | | 248,952 |
|
Municipal debt securities | | 12,036 |
| | 12 |
| | (5 | ) | | 12,043 |
| | 12,062 |
| | 33 |
| | (7 | ) | | 12,088 |
|
Corporate debt securities | | 369,792 |
| | 875 |
| | (580 | ) | | 370,087 |
| | 351,309 |
| | 1,492 |
| | (84 | ) | | 352,717 |
|
Residential mortgage and asset-backed securities | | 80,240 |
| | 42 |
| | (327 | ) | | 79,955 |
| | 82,717 |
| | 156 |
| | (141 | ) | | 82,732 |
|
Total | | $ | 2,635,999 |
| | $ | 1,190 |
| | $ | (1,434 | ) | | $ | 2,635,755 |
| | $ | 2,192,791 |
| | $ | 2,218 |
| | $ | (261 | ) | | $ | 2,194,748 |
|
Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. The following table summarizes the classification of the available-for-sale debt securities on our Condensed Consolidated Balance Sheets (in thousands):
|
| | | | | | | | |
| | June 30, 2013 | | December 31, 2012 |
Cash and cash equivalents | | $ | 1,862,133 |
| | $ | 1,416,356 |
|
Short-term marketable securities | | 85,194 |
| | 58,556 |
|
Long-term marketable securities | | 688,428 |
| | 719,836 |
|
Total | | $ | 2,635,755 |
| | $ | 2,194,748 |
|
Cash and cash equivalents in the table above exclude cash of $340.0 million as of June 30, 2013 and $387.3 million as of December 31, 2012.
The following table summarizes our portfolio of available-for-sale debt securities by contractual maturity (in thousands): |
| | | | | | | | |
| | June 30, 2013 |
| | Amortized Cost | | Fair Value |
Less than one year | | $ | 1,947,248 |
| | $ | 1,947,328 |
|
Greater than one year but less than five years | | 671,277 |
| | 671,061 |
|
Greater than five years but less than ten years | | 4,707 |
| | 4,666 |
|
Greater than ten years | | 12,767 |
| | 12,700 |
|
Total | | $ | 2,635,999 |
| | $ | 2,635,755 |
|
The following table summarizes the gross realized gains and losses related to sales of marketable securities (in thousands):
|
| | | | | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended |
| | June 30, | | June 30, |
| | 2013 | | 2012 | | 2013 | | 2012 |
Gross realized gains on sales | | $ | 201 |
| | $ | 84 |
| | $ | 383 |
| | $ | 10,099 |
|
Gross realized losses on sales | | $ | (111 | ) | | $ | (5 | ) | | $ | (267 | ) | | $ | (40,101 | ) |
The cost of securities sold was determined based on the specific identification method.
The following table summarizes our available-for-sale debt securities that were in a continuous unrealized loss position, but were not deemed to be other-than-temporarily impaired (in thousands):
|
| | | | | | | | | | | | | | | | | | | | | | | | |
| | Less Than 12 Months | | 12 Months or Greater | | Total |
| | Gross Unrealized Losses | | Estimated Fair Value | | Gross Unrealized Losses | | Estimated Fair Value | | Gross Unrealized Losses | | Estimated Fair Value |
June 30, 2013 | | | | | | | | | | | | |
Debt securities: | | | | | | | | | | | | |
U.S. Treasury securities | | $ | (381 | ) | | $ | 113,183 |
| | $ | — |
| | $ | — |
| | $ | (381 | ) | | $ | 113,183 |
|
U.S. government agencies securities | | (141 | ) | | 57,875 |
| | — |
| | — |
| | (141 | ) | | 57,875 |
|
Municipal debt securities | | (5 | ) | | 5,170 |
| | — |
| | — |
| | (5 | ) | | 5,170 |
|
Corporate debt securities | | (579 | ) | | 158,603 |
| | (1 | ) | | 2,044 |
| | (580 | ) | | 160,647 |
|
Residential mortgage and asset-backed securities | | (168 | ) | | 55,652 |
| | (159 | ) | | 9,721 |
| | (327 | ) | | 65,373 |
|
Total | | $ | (1,274 | ) | | $ | 390,483 |
| | $ | (160 | ) | | $ | 11,765 |
| | $ | (1,434 | ) | | $ | 402,248 |
|
| | |
| | |
| | |
| | |
| | |
| | |
|
December 31, 2012 | | |
| | |
| | |
| | |
| | |
| | |
|
Debt securities: | | |
| | |
| | |
| | |
| | |
| | |
|
U.S. government agencies securities | | $ | (29 | ) | | $ | 26,306 |
| | $ | — |
| | $ | — |
| | $ | (29 | ) | | $ | 26,306 |
|
Municipal debt securities | | (7 | ) | | 3,993 |
| | — |
| | — |
| | (7 | ) | | 3,993 |
|
Corporate debt securities | | (84 | ) | | 72,722 |
| | — |
| | — |
| | (84 | ) | | 72,722 |
|
Residential mortgage and asset-backed securities | | (141 | ) | | 36,415 |
| | — |
| | — |
| | (141 | ) | | 36,415 |
|
Total | | $ | (261 | ) | | $ | 139,436 |
| | $ | — |
| | $ | — |
| | $ | (261 | ) | | $ | 139,436 |
|
We held a total of 120 securities as of June 30, 2013 and 47 securities as of December 31, 2012 that were in an unrealized loss position. Based on our review of these securities, we believe we had no other-than-temporary impairments on these securities as of June 30, 2013 and December 31, 2012 because we do not intend to sell these securities and it is not more likely than not that we will be required to sell these securities before the recovery of their amortized cost basis.
| |
4. | DERIVATIVE FINANCIAL INSTRUMENTS |
We operate in foreign countries, which exposes us to market risk associated with foreign currency exchange rate fluctuations between the U.S. dollar and various foreign currencies, the most significant of which is the euro. In order to manage this risk, we may hedge a portion of our foreign currency exposures related to outstanding monetary assets and liabilities as well as forecasted product sales using foreign currency exchange forward or option contracts. In general, the market risk related to these contracts is offset by corresponding gains and losses on the hedged transactions. The credit risk associated with these contracts is driven by changes in interest and currency exchange rates and, as a result, varies over time. By working only with major banks and closely monitoring current market conditions, we limit the risk that counterparties to these contracts may be unable to perform. We also limit our risk of loss by entering into contracts that permit net settlement at maturity. Therefore, our overall risk of loss in the event of a counterparty default is limited to the amount of any unrecognized gains on outstanding contracts (i.e., those contracts that have a positive fair value) at the date of default. We do not enter into derivative contracts for trading purposes.
We hedge our exposure to foreign currency exchange rate fluctuations for certain monetary assets and liabilities of our foreign subsidiaries that are denominated in a non-functional currency. The derivative instruments we use to hedge this exposure are not designated as hedges, and as a result, changes in their fair value are recorded in other income (expense), net on our Condensed Consolidated Statements of Income.
We hedge our exposure to foreign currency exchange rate fluctuations for forecasted product sales that are denominated in a non-functional currency. The derivative instruments we use to hedge this exposure are designated as cash flow hedges and have maturity dates of 18 months or less. Upon executing a hedging contract and quarterly thereafter, we assess prospective hedge effectiveness using a regression analysis which calculates the change in cash flow as a result of the hedge instrument. On a monthly basis, we assess retrospective hedge effectiveness using a dollar offset approach. We exclude time value from our effectiveness testing and recognize changes in the time value of the hedge in other income (expense), net. The effective component of our hedge is recorded as an unrealized gain or loss on the hedging instrument in accumulated OCI within stockholders' equity. When the hedged forecasted transaction occurs, the hedge is de-designated and the unrealized gains or losses are reclassified into product sales. The majority of gains and losses related to the hedged forecasted transactions reported in accumulated OCI at June 30, 2013 will be reclassified to product sales within 12 months.
The cash flow effects of our derivatives contracts for the six months ended June 30, 2013 and 2012 are included within net cash provided by operating activities in the Condensed Consolidated Statements of Cash Flows.
We had notional amounts on foreign currency exchange contracts outstanding of $3.59 billion at June 30, 2013 and $3.39 billion at December 31, 2012.
While all of our derivative contracts allow us the right to offset assets or liabilities, we have presented amounts on a gross basis. Under the International Swap Dealers Association, Inc. master agreements with the respective counterparties of the foreign currency exchange contracts, subject to applicable requirements, we are allowed to net settle transactions of the same currency with a single net amount payable by one party to the other. The following table summarizes the location and fair values of derivative instruments on our Condensed Consolidated Balance Sheets (in thousands):
|
| | | | | | | | | | | | |
| | June 30, 2013 |
| | Asset Derivatives | | Liability Derivatives |
| | Classification | | Fair Value | | Classification | | Fair Value |
Derivatives designated as hedges: | | | | | | | | |
Foreign currency exchange contracts | | Other current assets | | $ | 31,570 |
| | Other accrued liabilities | | $ | 13,704 |
|
Foreign currency exchange contracts | | Other long-term assets | | 9,793 |
| | Other long-term obligations | | — |
|
Total derivatives designated as hedges | | | | 41,363 |
| | | | 13,704 |
|
Derivatives not designated as hedges: | | | | |
| | | | |
|
Foreign currency exchange contracts | | Other current assets | | 66 |
| | Other accrued liabilities | | 171 |
|
Total derivatives not designated as hedges | | | | 66 |
| | | | 171 |
|
Total derivatives | | | | $ | 41,429 |
| | | | $ | 13,875 |
|
|
| | | | | | | | | | | | |
| | December 31, 2012 |
| | Asset Derivatives | | Liability Derivatives |
| | Classification | | Fair Value | | Classification | | Fair Value |
Derivatives designated as hedges: | | | | | | | | |
Foreign currency exchange contracts | | Other current assets | | $ | 14,556 |
| | Other accrued liabilities | | $ | 54,597 |
|
Foreign currency exchange contracts | | Other long-term assets | | 142 |
| | Other long-term obligations | | 10,630 |
|
Total derivatives designated as hedges | | | | 14,698 |
| | | | 65,227 |
|
Derivatives not designated as hedges: | | | | |
| | | | |
|
Foreign currency exchange contracts | | Other current assets | | 125 |
| | Other accrued liabilities | | 21 |
|
Total derivatives not designated as hedges | | | | 125 |
| | | | 21 |
|
Total derivatives | | | | $ | 14,823 |
| | | | $ | 65,248 |
|
The following table summarizes the effect of our foreign currency exchange contracts on our Condensed Consolidated Statements of Income (in thousands):
|
| | | | | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended |
| | June 30, | | June 30, |
| | 2013 | | 2012 | | 2013 | | 2012 |
Derivatives designated as hedges: | | | | | | | | |
Net gains recognized in OCI (effective portion) | | $ | 11,801 |
| | $ | 112,011 |
| | $ | 82,661 |
| | $ | 63,125 |
|
Net gains reclassified from accumulated OCI into product sales (effective portion) | | $ | 5,351 |
| | $ | 15,059 |
| | $ | 5,813 |
| | $ | 26,286 |
|
Net gains (losses) recognized in other income (expense), net (ineffective portion and amounts excluded from effectiveness testing) | | $ | 1,908 |
| | $ | (3,544 | ) | | $ | (224 | ) | | $ | (6,756 | ) |
Derivatives not designated as hedges: | | | | | | | | |
Net gains recognized in other income (expense), net | | $ | 9,077 |
| | $ | 93,592 |
| | $ | 41,697 |
| | $ | 66,418 |
|
From time to time, we may discontinue cash flow hedges and as a result, record related amounts in other income (expense), net on our Condensed Consolidated Statements of Income. For the three and six months ended June 30, 2013 and 2012 no material amounts were recorded as a result of the discontinuance of cash flow hedges.
As of June 30, 2013 and December 31, 2012, we held one type of financial instrument, derivative contracts related to foreign currency exchange contracts. The following table summarizes the potential effect of offsetting derivatives by type of financial instrument on our Condensed Consolidated Balance Sheets (in thousands):
|
| | | | | | | | | | | | | | | | | | | | | | | | |
June 30, 2013 |
Offsetting of Derivative Assets/Liabilities |
| | | | | | | | Gross Amounts Not Offset in the Condensed Consolidated Balance Sheet | | |
Description | | Gross Amounts of Recognized Assets/Liabilities | | Gross Amounts Offset in the Condensed Consolidated Balance Sheet | | Amounts of Assets/Liabilities Presented in the Condensed Consolidated Balance Sheet | | Derivative Financial Instruments | | Cash Collateral Received/Pledged | | Net Amount (Legal Offset) |
Derivative assets | | $ | 41,429 |
| | $ | — |
| | $ | 41,429 |
| | $ | (9,906 | ) | | $ | — |
| | $ | 31,523 |
|
Derivative liabilities | | (13,875 | ) | | — |
| | (13,875 | ) | | 9,906 |
| | — |
| | (3,969 | ) |
|
| | | | | | | | | | | | | | | | | | | | | | | | |
December 31, 2012 |
Offsetting of Derivative Assets/Liabilities |
| | | | | | | | Gross Amounts Not Offset in the Consolidated Balance Sheet | | |
Description | | Gross Amounts of Recognized Assets/Liabilities | | Gross Amounts Offset in the Consolidated Balance Sheet | | Amounts of Assets/Liabilities Presented in the Consolidated Balance Sheet | | Derivative Financial Instruments | | Cash Collateral Received/Pledged | | Net Amount (Legal Offset) |
Derivative assets | | $ | 14,823 |
| | $ | — |
| | $ | 14,823 |
| | $ | (9,644 | ) | | $ | — |
| | $ | 5,179 |
|
Derivative liabilities | | (65,248 | ) | | — |
| | (65,248 | ) | | 9,644 |
| | — |
| | (55,604 | ) |
YM BioSciences Inc.
We completed the acquisition of YM BioSciences Inc. (YM) for total consideration transferred of $487.6 million on February 8, 2013, at which time YM became a wholly-owned subsidiary of Gilead. YM was a drug development company primarily focused on advancing momelotinib (formally known as CYT387), an orally administered, once-daily candidate for hematologic cancers.
The purchase accounting is preliminary as management is awaiting data needed to finalize its review of the deferred tax assets and related valuation allowances. We expect to finalize the purchase accounting during the second half of 2013. The preliminary fair values of acquired assets and assumed liabilities include primarily in-process research and development (IPR&D) of $362.7 million, goodwill of $127.2 million, deferred tax liabilities of $108.8 million and cash acquired of $108.9 million. Pro forma results of operations for the acquisition of YM have not been presented because this acquisition is not material to our consolidated results of operations. See Note 7, Intangible Assets and Goodwill for a description of the IPR&D acquired.
Inventories are summarized as follows (in thousands):
|
| | | | | | | | |
| | June 30, 2013 | | December 31, 2012 |
Raw materials | | $ | 884,600 |
| | $ | 826,545 |
|
Work in process | | 453,339 |
| | 358,525 |
|
Finished goods | | 597,208 |
| | 559,912 |
|
Total | | $ | 1,935,147 |
| | $ | 1,744,982 |
|
The joint ventures formed by Gilead and BMS (See Note 8, Collaborative Arrangements), which are included in our Condensed Consolidated Financial Statements, held $1.35 billion as of June 30, 2013 and $1.26 billion as of December 31, 2012, in inventory of efavirenz active pharmaceutical ingredient which was purchased from BMS at BMS's estimated net selling price of efavirenz.
| |
7. | INTANGIBLE ASSETS AND GOODWILL |
Intangible Assets
The following table summarizes the carrying amount of our intangible assets (in thousands):
|
| | | | | | | | |
| | June 30, 2013 | | December 31, 2012 |
Indefinite-lived intangible assets | | $ | 11,348,900 |
| | $ | 10,986,200 |
|
Finite-lived intangible assets | | 707,102 |
| | 750,193 |
|
Total intangible assets | | $ | 12,056,002 |
| | $ | 11,736,393 |
|
Indefinite-Lived Intangible Assets
Our indefinite-lived intangible assets consisted primarily of the purchased IPR&D related to sofosbuvir from our acquisition of Pharmasset, Inc. (Pharmasset) in January 2012. We completed our acquisition of YM in February 2013. Of the total $487.6 million preliminary fair value of acquired assets and assumed liabilities for YM, we attributed approximately $362.7 million to IPR&D related to momelotinib on our Condensed Consolidated Balance Sheet. The following table summarizes our indefinite-lived intangible assets (in thousands):
|
| | | | | | | | |
| | June 30, 2013 | | December 31, 2012 |
Indefinite-lived intangible asset - Sofosbuvir | | $ | 10,720,000 |
| | $ | 10,720,000 |
|
Indefinite-lived intangible asset - Momelotinib (formerly CYT387) | | 362,700 |
| | — |
|
Indefinite-lived intangible assets - Other | | 266,200 |
| | 266,200 |
|
Total | | $ | 11,348,900 |
| | $ | 10,986,200 |
|
Finite-Lived Intangible Assets
The following table summarizes our finite-lived intangible assets (in thousands):
|
| | | | | | | | | | | | | | | | |
| | June 30, 2013 | | December 31, 2012 |
| | Gross Carrying Amount | | Accumulated Amortization | | Gross Carrying Amount | | Accumulated Amortization |
Intangible asset - Ranexa | | $ | 688,400 |
| | $ | 161,984 |
| | $ | 688,400 |
| | $ | 133,119 |
|
Intangible asset - Lexiscan | | 262,800 |
| | 108,338 |
| | 262,800 |
| | 95,466 |
|
Other | | 42,995 |
| | 16,771 |
| | 42,995 |
| | 15,417 |
|
Total | | $ | 994,195 |
| | $ | 287,093 |
| | $ | 994,195 |
| | $ | 244,002 |
|
Amortization expense related to finite-lived intangible assets included in cost of goods sold in our Condensed Consolidated Statements of Income totaled $21.5 million and $43.1 million for the three and six months ended June 30, 2013, respectively, and $15.8 million and $31.7 million for the three and six months ended June 30, 2012, respectively. The weighted-average amortization period for these intangible assets is approximately 11 years. As of June 30, 2013, the estimated future amortization expense associated with our intangible assets for the remaining six months of 2013 and each of the five succeeding fiscal years is as follows (in thousands):
|
| | | |
Fiscal Year | Amount |
2013 (remaining six months) | $ | 43,091 |
|
2014 | 92,441 |
|
2015 | 97,673 |
|
2016 | 107,312 |
|
2017 | 116,137 |
|
2018 | 124,561 |
|
Total | $ | 581,215 |
|
Goodwill
Upon completing the acquisition of YM, we preliminarily attributed $127.2 million to goodwill on our Condensed Consolidated Balance Sheets. The following table summarizes the changes in the carrying amount of goodwill (in thousands): |
| | | |
Balance at December 31, 2012 | $ | 1,060,919 |
|
Goodwill resulting from the acquisition of YM | 127,238 |
|
Balance at June 30, 2013 | $ | 1,188,157 |
|
| |
8. | COLLABORATIVE ARRANGEMENTS |
From time to time, as a result of entering into strategic collaborations, we may hold investments in non-public companies. We review our interests in investee companies for consolidation and/or appropriate disclosure based on applicable guidance. For variable interest entities (VIEs), we may be required to consolidate an entity if the contractual terms of the arrangement essentially provide us with control over the entity, even if we do not have a majority voting interest. We assess whether we are the primary beneficiary of a VIE 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. As of June 30, 2013, we determined that certain of our investee companies are VIEs; however, other than with respect to our joint ventures with BMS, we are not the primary beneficiary and therefore do not consolidate these investees.
Bristol-Myers Squibb Company
North America
In 2004, we entered into a collaboration arrangement with BMS in the United States to develop and commercialize a single tablet regimen containing our Truvada and BMS's Sustiva (efavirenz). This combination was approved for use in the United States in 2006 and is sold under the brand name Atripla. We and BMS structured this collaboration as a joint venture that operates as a limited liability company named Bristol-Myers Squibb & Gilead Sciences, LLC, which we consolidate. Under the terms of the collaboration we and BMS granted royalty free sublicenses to the joint venture for the use of our respective company owned technologies and, in return, were granted a license by the joint venture to use any intellectual property that results from the collaboration. In 2006, we and BMS amended the joint venture's collaboration agreement to allow the joint venture to sell Atripla in Canada. The economic interests of the joint venture held by us and BMS (including share of revenues and out-of-pocket expenses) are based on the portion of the net selling price of Atripla attributable to efavirenz and Truvada. Since the net selling price for Truvada may change over time relative to the net selling price of efavirenz, both our and BMS's respective economic interests in the joint venture may vary annually.
We and BMS shared marketing and sales efforts. Since the second quarter of 2011, except for a limited number of activities that will be jointly managed, the parties no longer coordinate detailing and promotional activities in the United States, and the parties have begun to reduce their joint promotional efforts since we launched Complera in August 2011 and Stribild in August 2012. The parties will continue to collaborate on activities such as manufacturing, regulatory, compliance and pharmacovigilance. The daily operations of the joint venture are governed by four primary joint committees formed by both BMS and Gilead. We are responsible for accounting, financial reporting, tax reporting, manufacturing and product distribution for the joint venture. Both parties provide their respective bulk active pharmaceutical ingredients to the joint venture at their approximate market values. The agreement will continue until terminated by the mutual agreement of the parties. In addition, either party may terminate the other party's participation in the collaboration within 30 days after the launch of at least one generic version of such other party's single agent products (or the double agent products). The non-terminating party then has the right to continue to sell Atripla, but will be obligated to pay the terminating party certain royalties for a three-year period following the effective date of the termination.
As of June 30, 2013 and December 31, 2012, the joint venture held efavirenz active pharmaceutical ingredient which it purchased from BMS at BMS's estimated net selling price of efavirenz in the U.S. market. These amounts are included in inventories on our Condensed Consolidated Balance Sheets. As of June 30, 2013, total assets held by the joint venture were $2.33 billion and consisted primarily of cash and cash equivalents of $186.2 million, accounts receivable of $255.3 million and inventories of $1.87 billion; total liabilities were $985.4 million and consisted primarily of accounts payable of $621.4 million and other accrued expenses of $361.4 million. As of December 31, 2012, total assets held by the joint venture were $1.95 billion and consisted primarily of cash and cash equivalents of $191.1 million, accounts receivable of $223.7 million and inventories of $1.54 billion; total liabilities were $1.32 billion and consisted primarily of accounts payable of $501.7 million and other accrued expenses of $291.5 million. These asset and liability amounts do not include intercompany receivables or payables that are eliminated in our Condensed Consolidated Balance Sheets. Although we consolidate the joint venture, the legal structure of the joint venture limits the recourse that its creditors will have over our general credit or assets. Similarly, the assets held in the joint venture can be used only to settle obligations of the joint venture.
Europe
In 2007, Gilead Sciences Limited, our wholly-owned subsidiary in Ireland, and BMS entered into a collaboration agreement with BMS which sets forth the terms and conditions under which we and BMS will commercialize and distribute Atripla in the European Union, Iceland, Liechtenstein, Norway and Switzerland (collectively, the European Territory). The parties formed a limited liability company which we consolidate, to manufacture Atripla for distribution in the European Territory using efavirenz that it purchases from BMS at BMS's estimated net selling price of efavirenz in the European Territory. We are responsible for manufacturing, product distribution, inventory management and warehousing. Through our local subsidiaries, we have primary responsibility for order fulfillment, collection of receivables, customer relations and handling of sales returns in all the territories where we and BMS promote Atripla. In general, the parties share revenues and out-of-pocket expenses in proportion to the net selling prices of the components of Atripla, Truvada and efavirenz.
Starting in 2012, except for a limited number of activities that will be jointly managed, the parties no longer coordinate detailing and promotional activities in the region. We are responsible for accounting, financial reporting and tax reporting for
the collaboration. As of June 30, 2013 and December 31, 2012, efavirenz purchased from BMS at BMS's estimated net selling price of efavirenz in the European Territory is included in inventories on our Condensed Consolidated Balance Sheets.
The parties also formed a limited liability company to hold the marketing authorization for Atripla in Europe. We have primary responsibility for regulatory activities. In the major market countries, both parties have agreed to independently continue to use commercially reasonable efforts to promote Atripla.
Financing Arrangements
The following table summarizes the carrying amount of our borrowings under various financing arrangements (in thousands):
|
| | | | | | | | | | | | | | | | |
Type of Borrowing | | Description | | Issue Date | | Due Date | | Interest Rate | | June 30, 2013 | | December 31, 2012 |
Convertible Senior | | May 2013 Notes | | April 2006 | | May 2013 | | 0.625% | | $ | — |
| | $ | 419,433 |
|
Convertible Senior | | May 2014 Notes | | July 2010 | | May 2014 | | 1.00% | | 888,170 |
| | 1,210,213 |
|
Convertible Senior | | May 2016 Notes | | July 2010 | | May 2016 | | 1.625% | | 1,162,018 |
| | 1,157,692 |
|
Senior Unsecured | | April 2021 Notes | | March 2011 | | April 2021 | | 4.50% | | 993,352 |
| | 992,923 |
|
Senior Unsecured | | December 2014 Notes | | December 2011 | | December 2014 | | 2.40% | | 749,552 |
| | 749,394 |
|
Senior Unsecured | | December 2016 Notes | | December 2011 | | December 2016 | | 3.05% | | 699,210 |
| | 699,095 |
|
Senior Unsecured | | December 2021 Notes | | December 2011 | | December 2021 | | 4.40% | | 1,247,573 |
| | 1,247,428 |
|
Senior Unsecured | | December 2041 Notes | | December 2011 | | December 2041 | | 5.65% | | 997,847 |
| | 997,810 |
|
Credit Facility | | Five-Year Revolver | | January 2012 | | January 2017 | | Variable | | 600,000 |
| | 750,000 |
|
Total debt, net | | $ | 7,337,722 |
| | $ | 8,223,988 |
|
Less current portion | | 1,488,170 |
| | 1,169,433 |
|
Total long-term debt, net | | $ | 5,849,552 |
| | $ | 7,054,555 |
|
Maturity of 2013 Convertible Senior Notes
During the six months ended June 30, 2013, a portion of our May 2013 Notes were converted and on May 1, 2013, the remainder matured. We repaid an aggregate principal balance of $426.3 million and $714.0 million in cash related to the conversion spread, which represents the conversion value in excess of the principal amount. We received $714.0 million in cash from the related convertible note hedges. The warrants related to our May 2013 Notes expire in August 2013.
Convertible Senior Notes
During the six months ended June 30, 2013, a portion of the May 2014 Notes and May 2016 Notes was converted. We repaid $353.0 million of the principal balance, primarily composed of May 2014 Notes. We also paid $492.0 million in cash related to the conversion spread of the notes, which represents the conversion value in excess of the principal amount, and received $492.0 million in cash from our convertible note hedges related to these notes.
Credit Facility
During the six months ended June 30, 2013, we repaid $150.0 million under the Five-Year Revolving Credit Agreement. The Five-Year Revolving Credit Agreement bears interest at either (i) the Eurodollar Rate plus the Applicable Margin or (ii) the Base Rate plus the Applicable Margin, each as defined in the credit agreement. We may reduce the commitments and may prepay the loan in whole or in part at any time without premium or penalty. We are required to comply with certain covenants under the credit agreement and notes indentures and as of June 30, 2013, we were in compliance with all such covenants.
| |
10. | COMMITMENTS AND CONTINGENCIES |
Legal Proceedings
Department of Justice Investigation
In June 2011, we received a subpoena from the U.S. Attorney's Office for the Northern District of California requesting documents related to the manufacture, and related quality and distribution practices, of Atripla, Emtriva, Hepsera, Letairis, Truvada, Viread and Complera. We have been cooperating and will continue to cooperate with this governmental inquiry. An estimate of a possible loss or range of losses cannot be determined.
Litigation with Generic Manufacturers
As part of the approval process of some of our products, the U.S. Food and Drug Administration (FDA) granted a New Chemical Entity exclusivity period during which other manufacturers' applications for approval of generic versions of our product will not be granted. Generic manufacturers may challenge the patents protecting products that have been granted exclusivity one year prior to the end of the exclusivity period. Generic manufacturers have sought and may continue to seek FDA approval for a similar or identical drug through an abbreviated new drug application (ANDA), the application form typically used by manufacturers seeking approval of a generic drug.
We received notices that generic manufacturers have submitted ANDAs to manufacture a generic version of Atripla, Truvada, Viread, Hepsera, Emtriva, Ranexa and Tamiflu in the United States and Atripla, Truvada and Viread in Canada. We expect to begin trial with some of the generic manufacturers in 2013. In April 2013, we and Teva Pharmaceuticals (Teva) reached an agreement to settle the ongoing patent litigation concerning the four patents that protect tenofovir disoproxil fumarate in our Atripla, Truvada and Viread products. Under the agreement, Teva will be allowed to launch a generic version of Viread on December 15, 2017. The settlement agreement was filed and is under review by the Federal Trade Commission and Department of Justice. As a result of the recent invalidation of the patents protecting entecavir and due to declining sales of Hepsera in the United States, in March 2013, we granted Sigmapharm Labs (Sigmapharm) a Covenant Not to Sue and filed a motion to dismiss all claims in the lawsuit in March 2013. Once Sigmapharm obtains FDA approval of its product it may elect to launch its generic product. The trial related to the U.S. patents associated with Ranexa took place in April and May 2013. The court has not yet issued a decision in that case. The trial related to two Canadian patents associated with Atripla, Truvada and Viread is currently scheduled for September 2013. The trial related to the U.S. patents protecting emtricitabine is scheduled to begin in October 2013.
We cannot predict the ultimate outcome of these actions, and we may spend significant resources enforcing and defending these patents. If we are unsuccessful in these lawsuits, some or all of our original claims in the patents may be narrowed or invalidated and the patent protection for Atripla, Truvada, Viread, Hepsera, Emtriva, Ranexa and Tamiflu in the United States and Atripla, Truvada and Viread in Canada could be substantially shortened. Further, if all of the patents covering one or more products are invalidated, the FDA or Canadian Ministry of Health could approve the requests to manufacture a generic version of such products in the United States or Canada, respectively, prior to the expiration date of those patents. The sale of generic versions of these products earlier than their patent expiration would have a significant negative effect on our revenues and results of operations.
Other Matters
We are a party to various legal actions that arose in the ordinary course of our business. We do not believe that these other legal actions will have a material adverse impact on our consolidated business, financial position or results of operations.
| |
11. | STOCK-BASED COMPENSATION |
The following table summarizes the stock-based compensation expense included in our Condensed Consolidated Statements of Income (in thousands):
|
| | | | | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended |
| | June 30, | | June 30, |
| | 2013 | | 2012 | | 2013 | | 2012 |
Cost of goods sold | | $ | 2,632 |
| | $ | 2,119 |
| | $ | 4,473 |
| | $ | 4,220 |
|
Research and development expenses | | 24,646 |
| | 20,355 |
| | 51,521 |
| | 138,977 |
|
Selling, general and administrative expenses | | 28,675 |
| | 25,929 |
| | 61,726 |
| | 147,874 |
|
Stock-based compensation expense included in total costs and expenses | | 55,953 |
| | 48,403 |
| | 117,720 |
| | 291,071 |
|
Income tax effect | | (15,574 | ) | | (13,167 | ) | | (31,961 | ) | | (26,231 | ) |
Stock-based compensation expense, net of tax | | $ | 40,379 |
| | $ | 35,236 |
| | $ | 85,759 |
| | $ | 264,840 |
|
Total stock-based compensation for the six months ended June 30, 2012 included $100.1 million in R&D expenses and $93.8 million in selling, general and administrative expenses, related to the acceleration of unvested stock options in connection with the acquisition of Pharmasset, which closed during the first quarter of 2012.
Stock Repurchase Program
In February 2013, we suspended our share repurchase program in order to focus on debt repayment. During the three months ended June 30, 2013, we did not repurchase shares of common stock under our January 2011 stock repurchase program. During the six months ended June 30, 2013, we repurchased a total of $82.2 million or 2.1 million shares of common stock under our January 2011 stock repurchase program.
Accumulated Other Comprehensive Income
The following table summarizes the changes in accumulated OCI by component, net of tax (in thousands):
|
| | | | | | | | | | | | | | | | |
| | Foreign Currency Items | | Unrealized Gains and Losses on Available-for-Sale Securities | | Unrealized Gains and Losses on Cash Flow Hedges | | Total |
Balance at December 31, 2012 | | $ | (1,420 | ) | | $ | 7,502 |
| | $ | (51,697 | ) | | $ | (45,615 | ) |
Other comprehensive income (loss) before reclassifications | | 2,774 |
| | (234 | ) | | 79,082 |
| | 81,622 |
|
Amounts reclassified from accumulated other comprehensive income | | — |
| | (75 | ) | | (5,561 | ) | | (5,636 | ) |
Net current period other comprehensive income (loss) | | 2,774 |
| | (309 | ) | | 73,521 |
| | 75,986 |
|
Balance at June 30, 2013 | | $ | 1,354 |
| | $ | 7,193 |
| | $ | 21,824 |
| | $ | 30,371 |
|
Certain prior period amounts have been reclassified within accumulated OCI to conform to the current presentation.
For the three and six months ended June 30, 2013, amounts reclassified from accumulated OCI to net income were not significant. Amounts reclassified for gains (losses) on cash flow hedges were recorded as part of product sales on our Condensed Consolidated Statements of Income. Amounts reclassified for unrealized gains (losses) on available-for-sale securities were recorded as part of other income (expense), net on our Condensed Consolidated Statements of Income.
We operate in one business segment, which primarily focuses on the discovery, development and commercialization of innovative medicines in areas of unmet medical need. All products are included in one segment, because the majority of our products have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment.
Product sales consist of the following (in thousands):
|
| | | | | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended |
| | June 30, | | June 30, |
| | 2013 | | 2012 | | 2013 | | 2012 |
Antiviral products: | | | | | | | | |
Atripla | | $ | 938,108 |
| | $ | 904,023 |
| | $ | 1,815,181 |
| | $ | 1,791,619 |
|
Truvada | | 807,779 |
| | 785,933 |
| | 1,508,021 |
| | 1,544,196 |
|
Viread | | 250,188 |
| | 215,414 |
| | 460,520 |
| | 407,107 |
|
Complera/Eviplera | | 188,683 |
| | 72,909 |
| | 336,872 |
| |