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ý
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended September 30, 2013
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from ________ to ________
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Delaware
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94-3047598
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(State or Other Jurisdiction of
Incorporation or Organization)
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(IRS Employer
Identification No.)
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333 Lakeside Drive, Foster City, California
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94404
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(Address of principal executive offices)
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(Zip Code)
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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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PART I.
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FINANCIAL INFORMATION
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ITEM I.
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CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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September 30, 2013
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December 31, 2012
|
||||
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(unaudited)
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||||
Assets
|
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|
||||
Current assets:
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|
||||
Cash and cash equivalents
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$
|
2,010,736
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|
|
$
|
1,803,694
|
|
Short-term marketable securities
|
79,758
|
|
|
58,556
|
|
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Accounts receivable, net
|
1,971,926
|
|
|
1,751,388
|
|
||
Inventories
|
1,946,048
|
|
|
1,744,982
|
|
||
Deferred tax assets
|
239,287
|
|
|
262,641
|
|
||
Prepaid taxes
|
462,704
|
|
|
348,420
|
|
||
Prepaid expenses
|
148,407
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|
|
102,364
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|
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Other current assets
|
109,195
|
|
|
84,302
|
|
||
Total current assets
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6,968,061
|
|
|
6,156,347
|
|
||
Property, plant and equipment, net
|
1,133,032
|
|
|
1,100,259
|
|
||
Long-term portion of prepaid royalties
|
177,450
|
|
|
175,790
|
|
||
Long-term deferred tax assets
|
162,738
|
|
|
131,107
|
|
||
Long-term marketable securities
|
665,063
|
|
|
719,836
|
|
||
Intangible assets, net
|
12,034,457
|
|
|
11,736,393
|
|
||
Goodwill
|
1,188,157
|
|
|
1,060,919
|
|
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Other long-term assets
|
139,470
|
|
|
159,187
|
|
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Total assets
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$
|
22,468,428
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$
|
21,239,838
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|
||||
Liabilities and Stockholders’ Equity
|
|
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|
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Current liabilities:
|
|
|
|
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|
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Accounts payable
|
$
|
1,350,402
|
|
|
$
|
1,327,339
|
|
Accrued government rebates
|
904,421
|
|
|
745,148
|
|
||
Accrued compensation and employee benefits
|
228,245
|
|
|
236,716
|
|
||
Income taxes payable
|
10,651
|
|
|
13,403
|
|
||
Other accrued liabilities
|
816,748
|
|
|
674,762
|
|
||
Deferred revenues
|
127,278
|
|
|
103,162
|
|
||
Current portion of long-term debt and other obligations, net
|
1,457,379
|
|
|
1,169,490
|
|
||
Total current liabilities
|
4,895,124
|
|
|
4,270,020
|
|
||
Long-term deferred revenues
|
25,398
|
|
|
20,532
|
|
||
Long-term debt, net
|
5,856,093
|
|
|
7,054,555
|
|
||
Long-term income taxes payable
|
119,589
|
|
|
115,822
|
|
||
Long-term deferred tax liabilities
|
118,660
|
|
|
10,190
|
|
||
Other long-term obligations
|
261,091
|
|
|
217,850
|
|
||
Commitments and contingencies (Note 10)
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock, par value $0.001 per share; 5,000 shares authorized; none outstanding
|
—
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|
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—
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|
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Common stock, par value $0.001 per share; 5,600,000 shares authorized; 1,534,028 and 1,519,163 shares issued and outstanding
|
763
|
|
|
760
|
|
||
Additional paid-in capital
|
5,189,582
|
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|
5,649,850
|
|
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Accumulated other comprehensive loss
|
(42,070
|
)
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|
(45,615
|
)
|
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Retained earnings
|
5,735,335
|
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|
3,704,744
|
|
||
Total Gilead stockholders’ equity
|
10,883,610
|
|
|
9,309,739
|
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||
Noncontrolling interest
|
308,863
|
|
|
241,130
|
|
||
Total stockholders’ equity
|
11,192,473
|
|
|
9,550,869
|
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Total liabilities and stockholders’ equity
|
$
|
22,468,428
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|
$
|
21,239,838
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Three Months Ended
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Nine Months Ended
|
||||||||||||
|
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September 30,
|
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September 30,
|
||||||||||||
|
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2013
|
|
2012
|
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2013
|
|
2012
|
||||||||
Revenues:
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Product sales
|
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$
|
2,709,652
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$
|
2,357,978
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$
|
7,760,505
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$
|
6,887,560
|
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Royalty revenues
|
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69,779
|
|
|
63,915
|
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|
310,700
|
|
|
216,126
|
|
||||
Contract and other revenues
|
|
3,402
|
|
|
4,704
|
|
|
10,657
|
|
|
10,546
|
|
||||
Total revenues
|
|
2,782,833
|
|
|
2,426,597
|
|
|
8,081,862
|
|
|
7,114,232
|
|
||||
Costs and expenses:
|
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|
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|
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|
||||||||
Cost of goods sold
|
|
681,868
|
|
|
597,269
|
|
|
2,000,979
|
|
|
1,795,545
|
|
||||
Research and development
|
|
546,244
|
|
|
465,831
|
|
|
1,567,778
|
|
|
1,320,286
|
|
||||
Selling, general and administrative
|
|
406,860
|
|
|
319,583
|
|
|
1,186,147
|
|
|
1,095,209
|
|
||||
Total costs and expenses
|
|
1,634,972
|
|
|
1,382,683
|
|
|
4,754,904
|
|
|
4,211,040
|
|
||||
Income from operations
|
|
1,147,861
|
|
|
1,043,914
|
|
|
3,326,958
|
|
|
2,903,192
|
|
||||
Interest expense
|
|
(73,949
|
)
|
|
(89,322
|
)
|
|
(233,744
|
)
|
|
(275,010
|
)
|
||||
Other income (expense), net
|
|
5,777
|
|
|
(3,505
|
)
|
|
2,222
|
|
|
(38,665
|
)
|
||||
Income before provision for income taxes
|
|
1,079,689
|
|
|
951,087
|
|
|
3,095,436
|
|
|
2,589,517
|
|
||||
Provision for income taxes
|
|
294,473
|
|
|
280,052
|
|
|
824,892
|
|
|
774,877
|
|
||||
Net income
|
|
785,216
|
|
|
671,035
|
|
|
2,270,544
|
|
|
1,814,640
|
|
||||
Net loss attributable to noncontrolling interest
|
|
3,390
|
|
|
4,470
|
|
|
12,853
|
|
|
14,385
|
|
||||
Net income attributable to Gilead
|
|
$
|
788,606
|
|
|
$
|
675,505
|
|
|
$
|
2,283,397
|
|
|
$
|
1,829,025
|
|
Net income per share attributable to Gilead common stockholders—basic
|
|
$
|
0.51
|
|
|
$
|
0.45
|
|
|
$
|
1.50
|
|
|
$
|
1.21
|
|
Shares used in per share calculation—basic
|
|
1,532,105
|
|
|
1,514,770
|
|
|
1,526,847
|
|
|
1,514,064
|
|
||||
Net income per share attributable to Gilead common stockholders—diluted
|
|
$
|
0.47
|
|
|
$
|
0.43
|
|
|
$
|
1.35
|
|
|
$
|
1.17
|
|
Shares used in per share calculation—diluted
|
|
1,691,898
|
|
|
1,584,608
|
|
|
1,689,647
|
|
|
1,567,648
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
September 30,
|
|
September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Net income
|
|
$
|
785,216
|
|
|
$
|
671,035
|
|
|
$
|
2,270,544
|
|
|
$
|
1,814,640
|
|
Other comprehensive income:
|
|
|
|
|
|
|
|
|
||||||||
Net foreign currency translation gain, net of tax
|
|
2,381
|
|
|
5,090
|
|
|
5,155
|
|
|
7,346
|
|
||||
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
||||||||
Net unrealized gain, net of tax impact of $2,182, $(848), $2,310 and $(660)
|
|
4,316
|
|
|
1,476
|
|
|
4,082
|
|
|
1,146
|
|
||||
Reclassifications to net income, net of tax impact of $(38), $1,396, $(79) and $849
|
|
(65
|
)
|
|
2,429
|
|
|
(140
|
)
|
|
32,979
|
|
||||
Net change
|
|
4,251
|
|
|
3,905
|
|
|
3,942
|
|
|
34,125
|
|
||||
Cash flow hedges:
|
|
|
|
|
|
|
|
|
||||||||
Net unrealized loss, net of tax impact of $6,083, $3,180, $2,504 and $460
|
|
(82,453
|
)
|
|
(67,674
|
)
|
|
(3,371
|
)
|
|
(9,084
|
)
|
||||
Reclassifications to net income, net of tax impact of $(358), $(1,760), $(610) and $(3,156)
|
|
3,380
|
|
|
(37,449
|
)
|
|
(2,181
|
)
|
|
(62,338
|
)
|
||||
Net change
|
|
(79,073
|
)
|
|
(105,123
|
)
|
|
(5,552
|
)
|
|
(71,422
|
)
|
||||
Other comprehensive income (loss)
|
|
(72,441
|
)
|
|
(96,128
|
)
|
|
3,545
|
|
|
(29,951
|
)
|
||||
Comprehensive income
|
|
712,775
|
|
|
574,907
|
|
|
2,274,089
|
|
|
1,784,689
|
|
||||
Comprehensive loss attributable to noncontrolling interest
|
|
3,390
|
|
|
4,470
|
|
|
12,853
|
|
|
14,385
|
|
||||
Comprehensive income attributable to Gilead
|
|
$
|
716,165
|
|
|
$
|
579,377
|
|
|
$
|
2,286,942
|
|
|
$
|
1,799,074
|
|
|
|
Nine Months Ended
|
||||||
|
|
September 30,
|
||||||
|
|
2013
|
|
2012
|
||||
Operating Activities:
|
|
|
|
|
||||
Net income
|
|
$
|
2,270,544
|
|
|
$
|
1,814,640
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
|
||||
Depreciation expense
|
|
76,046
|
|
|
60,488
|
|
||
Amortization expense
|
|
140,699
|
|
|
144,087
|
|
||
Stock-based compensation expense
|
|
180,293
|
|
|
151,598
|
|
||
Excess tax benefits from stock-based compensation
|
|
(168,728
|
)
|
|
(64,955
|
)
|
||
Tax benefits from employee stock plans
|
|
169,916
|
|
|
61,401
|
|
||
Deferred income taxes
|
|
(12,400
|
)
|
|
21,374
|
|
||
Other
|
|
45,116
|
|
|
(2,037
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
||||
Accounts receivable, net
|
|
(226,308
|
)
|
|
160,831
|
|
||
Inventories
|
|
(216,650
|
)
|
|
(224,742
|
)
|
||
Prepaid expenses and other assets
|
|
(111,199
|
)
|
|
(109,550
|
)
|
||
Accounts payable
|
|
23,131
|
|
|
146,458
|
|
||
Income taxes payable
|
|
(87,081
|
)
|
|
(75,674
|
)
|
||
Accrued liabilities
|
|
265,765
|
|
|
397,831
|
|
||
Deferred revenues
|
|
29,057
|
|
|
7,238
|
|
||
Net cash provided by operating activities
|
|
2,378,201
|
|
|
2,488,988
|
|
||
|
|
|
|
|
||||
Investing Activities:
|
|
|
|
|
||||
Purchases of marketable securities
|
|
(254,657
|
)
|
|
(1,148,751
|
)
|
||
Proceeds from sales of marketable securities
|
|
226,291
|
|
|
130,463
|
|
||
Proceeds from maturities of marketable securities
|
|
57,556
|
|
|
25,975
|
|
||
Purchases of other investments
|
|
—
|
|
|
(25,000
|
)
|
||
Acquisitions, net of cash acquired
|
|
(378,645
|
)
|
|
(10,751,636
|
)
|
||
Capital expenditures
|
|
(121,310
|
)
|
|
(127,175
|
)
|
||
Net cash used in investing activities
|
|
(470,765
|
)
|
|
(11,896,124
|
)
|
||
|
|
|
|
|
||||
Financing Activities:
|
|
|
|
|
||||
Proceeds from debt financing, net of issuance costs
|
|
—
|
|
|
2,144,733
|
|
||
Proceeds from convertible note hedges
|
|
1,257,869
|
|
|
—
|
|
||
Proceeds from issuances of common stock
|
|
240,671
|
|
|
350,264
|
|
||
Repurchases of common stock
|
|
(182,259
|
)
|
|
(467,000
|
)
|
||
Repayments of debt financing
|
|
(2,224,724
|
)
|
|
(1,050,000
|
)
|
||
Payments to settle warrants
|
|
(1,039,695
|
)
|
|
—
|
|
||
Repayments of other long-term obligations
|
|
(58
|
)
|
|
(2,167
|
)
|
||
Excess tax benefits from stock-based compensation
|
|
168,728
|
|
|
64,955
|
|
||
Contributions from (distributions to) noncontrolling interest
|
|
80,586
|
|
|
32,412
|
|
||
Net cash provided by (used in) financing activities
|
|
(1,698,882
|
)
|
|
1,073,197
|
|
||
Effect of exchange rate changes on cash
|
|
(1,512
|
)
|
|
872
|
|
||
Net change in cash and cash equivalents
|
|
207,042
|
|
|
(8,333,067
|
)
|
||
Cash and cash equivalents at beginning of period
|
|
1,803,694
|
|
|
9,883,777
|
|
||
Cash and cash equivalents at end of period
|
|
$
|
2,010,736
|
|
|
$
|
1,550,710
|
|
1.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
September 30,
|
|
September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
|
||||||||
Net income attributable to Gilead
|
|
$
|
788,606
|
|
|
$
|
675,505
|
|
|
$
|
2,283,397
|
|
|
$
|
1,829,025
|
|
Denominator:
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares of common stock outstanding used in the calculation of basic net income per share attributable to Gilead common stockholders
|
|
1,532,105
|
|
|
1,514,770
|
|
|
1,526,847
|
|
|
1,514,064
|
|
||||
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
||||||||
Stock options and equivalents
|
|
38,575
|
|
|
32,478
|
|
|
39,085
|
|
|
30,926
|
|
||||
Conversion spread related to the May 2013 Notes
|
|
—
|
|
|
11,446
|
|
|
5,268
|
|
|
8,950
|
|
||||
Conversion spread related to the May 2014 Notes
|
|
24,335
|
|
|
11,860
|
|
|
27,435
|
|
|
7,058
|
|
||||
Conversion spread related to the May 2016 Notes
|
|
33,873
|
|
|
11,452
|
|
|
30,587
|
|
|
6,650
|
|
||||
Warrants related to the Convertible Notes
|
|
63,010
|
|
|
2,602
|
|
|
60,425
|
|
|
—
|
|
||||
Weighted-average shares of common stock outstanding used in the calculation of diluted net income per share attributable to Gilead common stockholders
|
|
1,691,898
|
|
|
1,584,608
|
|
|
1,689,647
|
|
|
1,567,648
|
|
2.
|
FAIR VALUE MEASUREMENTS
|
•
|
Level 1 inputs which include quoted prices in active markets for identical assets or liabilities;
|
•
|
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
|
•
|
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.
|
|
|
|
|
September 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
|
|
857,322
|
|
|
2,443,534
|
|
|
1,210,213
|
|
|
2,040,363
|
|
||||
Convertible Senior
|
|
May 2016 Notes
|
|
1,168,117
|
|
|
3,464,641
|
|
|
1,157,692
|
|
|
2,110,938
|
|
||||
Senior Unsecured
|
|
April 2021 Notes
|
|
993,567
|
|
|
1,079,470
|
|
|
992,923
|
|
|
1,146,990
|
|
||||
Senior Unsecured
|
|
December 2014 Notes
|
|
749,631
|
|
|
765,015
|
|
|
749,394
|
|
|
772,650
|
|
||||
Senior Unsecured
|
|
December 2016 Notes
|
|
699,268
|
|
|
738,171
|
|
|
699,095
|
|
|
748,902
|
|
||||
Senior Unsecured
|
|
December 2021 Notes
|
|
1,247,644
|
|
|
1,336,600
|
|
|
1,247,428
|
|
|
1,420,725
|
|
||||
Senior Unsecured
|
|
December 2041 Notes
|
|
997,866
|
|
|
1,111,730
|
|
|
997,810
|
|
|
1,252,090
|
|
|
September 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
|
$
|
160,274
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
160,274
|
|
|
$
|
81,903
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
81,903
|
|
Money market funds
|
1,547,868
|
|
|
—
|
|
|
—
|
|
|
1,547,868
|
|
|
1,416,355
|
|
|
—
|
|
|
—
|
|
|
1,416,355
|
|
||||||||
U.S. government agencies securities
|
—
|
|
|
146,778
|
|
|
—
|
|
|
146,778
|
|
|
—
|
|
|
248,952
|
|
|
—
|
|
|
248,952
|
|
||||||||
Municipal debt securities
|
—
|
|
|
12,018
|
|
|
—
|
|
|
12,018
|
|
|
—
|
|
|
12,088
|
|
|
—
|
|
|
12,088
|
|
||||||||
Corporate debt securities
|
—
|
|
|
366,682
|
|
|
—
|
|
|
366,682
|
|
|
—
|
|
|
352,718
|
|
|
—
|
|
|
352,718
|
|
||||||||
Residential mortgage and asset-backed securities
|
—
|
|
|
78,319
|
|
|
—
|
|
|
78,319
|
|
|
—
|
|
|
82,732
|
|
|
—
|
|
|
82,732
|
|
||||||||
Total debt securities
|
1,708,142
|
|
|
603,797
|
|
|
—
|
|
|
2,311,939
|
|
|
1,498,258
|
|
|
696,490
|
|
|
—
|
|
|
2,194,748
|
|
||||||||
Derivatives
|
—
|
|
|
8,985
|
|
|
—
|
|
|
8,985
|
|
|
—
|
|
|
14,823
|
|
|
—
|
|
|
14,823
|
|
||||||||
|
$
|
1,708,142
|
|
|
$
|
612,782
|
|
|
$
|
—
|
|
|
$
|
2,320,924
|
|
|
$
|
1,498,258
|
|
|
$
|
711,313
|
|
|
$
|
—
|
|
|
$
|
2,209,571
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Contingent consideration
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
252,502
|
|
|
$
|
252,502
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
205,060
|
|
|
$
|
205,060
|
|
Derivatives
|
—
|
|
|
61,107
|
|
|
—
|
|
|
61,107
|
|
|
—
|
|
|
65,248
|
|
|
—
|
|
|
65,248
|
|
||||||||
|
$
|
—
|
|
|
$
|
61,107
|
|
|
$
|
252,502
|
|
|
$
|
313,609
|
|
|
$
|
—
|
|
|
$
|
65,248
|
|
|
$
|
205,060
|
|
|
$
|
270,308
|
|
Balance at December 31, 2012
|
|
$
|
205,060
|
|
Additions from new acquisitions
|
|
—
|
|
|
Net changes in valuation
|
|
47,442
|
|
|
Balance at September 30, 2013
|
|
$
|
252,502
|
|
3.
|
AVAILABLE-FOR-SALE SECURITIES
|
|
|
September 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
|
|
$
|
160,177
|
|
|
$
|
191
|
|
|
$
|
(94
|
)
|
|
$
|
160,274
|
|
|
$
|
81,752
|
|
|
$
|
151
|
|
|
$
|
—
|
|
|
$
|
81,903
|
|
Money market funds
|
|
1,547,868
|
|
|
—
|
|
|
—
|
|
|
1,547,868
|
|
|
1,416,356
|
|
|
—
|
|
|
—
|
|
|
1,416,356
|
|
||||||||
U.S. government agencies securities
|
|
146,414
|
|
|
364
|
|
|
—
|
|
|
146,778
|
|
|
248,595
|
|
|
386
|
|
|
(29
|
)
|
|
248,952
|
|
||||||||
Municipal debt securities
|
|
12,022
|
|
|
3
|
|
|
(7
|
)
|
|
12,018
|
|
|
12,062
|
|
|
33
|
|
|
(7
|
)
|
|
12,088
|
|
||||||||
Corporate debt securities
|
|
365,726
|
|
|
1,161
|
|
|
(205
|
)
|
|
366,682
|
|
|
351,309
|
|
|
1,492
|
|
|
(84
|
)
|
|
352,717
|
|
||||||||
Residential mortgage and asset-backed securities
|
|
78,478
|
|
|
28
|
|
|
(187
|
)
|
|
78,319
|
|
|
82,717
|
|
|
156
|
|
|
(141
|
)
|
|
82,732
|
|
||||||||
Total
|
|
$
|
2,310,685
|
|
|
$
|
1,747
|
|
|
$
|
(493
|
)
|
|
$
|
2,311,939
|
|
|
$
|
2,192,791
|
|
|
$
|
2,218
|
|
|
$
|
(261
|
)
|
|
$
|
2,194,748
|
|
|
|
September 30, 2013
|
|
December 31, 2012
|
||||
Cash and cash equivalents
|
|
$
|
1,567,118
|
|
|
$
|
1,416,356
|
|
Short-term marketable securities
|
|
79,758
|
|
|
58,556
|
|
||
Long-term marketable securities
|
|
665,063
|
|
|
719,836
|
|
||
Total
|
|
$
|
2,311,939
|
|
|
$
|
2,194,748
|
|
|
|
September 30, 2013
|
||||||
|
|
Amortized Cost
|
|
Fair Value
|
||||
Less than one year
|
|
$
|
1,646,748
|
|
|
$
|
1,646,876
|
|
Greater than one year but less than five years
|
|
652,601
|
|
|
653,837
|
|
||
Greater than five years but less than ten years
|
|
—
|
|
|
—
|
|
||
Greater than ten years
|
|
11,336
|
|
|
11,226
|
|
||
Total
|
|
$
|
2,310,685
|
|
|
$
|
2,311,939
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
September 30,
|
|
September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Gross realized gains on sales
|
|
$
|
269
|
|
|
$
|
25
|
|
|
$
|
652
|
|
|
$
|
10,124
|
|
Gross realized losses on sales
|
|
$
|
(166
|
)
|
|
$
|
(3,850
|
)
|
|
$
|
(433
|
)
|
|
$
|
(43,951
|
)
|
|
|
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 |
||||||||||||
September 30, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
U.S. Treasury securities
|
|
$
|
(94
|
)
|
|
$
|
41,591
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(94
|
)
|
|
$
|
41,591
|
|
Municipal debt securities
|
|
(7
|
)
|
|
9,168
|
|
|
—
|
|
|
—
|
|
|
(7
|
)
|
|
9,168
|
|
||||||
Corporate debt securities
|
|
(205
|
)
|
|
88,186
|
|
|
—
|
|
|
2,026
|
|
|
(205
|
)
|
|
90,212
|
|
||||||
Residential mortgage and asset-backed securities
|
|
(67
|
)
|
|
42,029
|
|
|
(120
|
)
|
|
12,441
|
|
|
(187
|
)
|
|
54,470
|
|
||||||
Total
|
|
$
|
(373
|
)
|
|
$
|
180,974
|
|
|
$
|
(120
|
)
|
|
$
|
14,467
|
|
|
$
|
(493
|
)
|
|
$
|
195,441
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
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
|
|
4.
|
DERIVATIVE FINANCIAL INSTRUMENTS
|
|
|
September 30, 2013
|
||||||||||
|
|
Asset Derivatives
|
|
Liability Derivatives
|
||||||||
|
|
Classification
|
|
Fair Value
|
|
Classification
|
|
Fair Value
|
||||
Derivatives designated as hedges:
|
|
|
|
|
|
|
|
|
||||
Foreign currency exchange contracts
|
|
Other current assets
|
|
$
|
8,389
|
|
|
Other accrued liabilities
|
|
$
|
52,385
|
|
Foreign currency exchange contracts
|
|
Other long-term assets
|
|
596
|
|
|
Other long-term obligations
|
|
8,687
|
|
||
Total derivatives designated as hedges
|
|
|
|
8,985
|
|
|
|
|
61,072
|
|
||
Derivatives not designated as hedges:
|
|
|
|
|
|
|
|
|
|
|
||
Foreign currency exchange contracts
|
|
Other current assets
|
|
—
|
|
|
Other accrued liabilities
|
|
35
|
|
||
Total derivatives not designated as hedges
|
|
|
|
—
|
|
|
|
|
35
|
|
||
Total derivatives
|
|
|
|
$
|
8,985
|
|
|
|
|
$
|
61,107
|
|
|
|
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
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
September 30,
|
|
September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Derivatives designated as hedges:
|
|
|
|
|
|
|
|
|
||||||||
Net losses recognized in OCI (effective portion)
|
|
$
|
(83,528
|
)
|
|
$
|
(70,855
|
)
|
|
$
|
(867
|
)
|
|
$
|
(7,730
|
)
|
Net gains (losses) reclassified from accumulated OCI into product sales (effective portion)
|
|
$
|
(3,022
|
)
|
|
$
|
39,209
|
|
|
$
|
2,791
|
|
|
$
|
65,494
|
|
Net gains (losses) recognized in other income (expense), net (ineffective portion and amounts excluded from effectiveness testing)
|
|
$
|
1,105
|
|
|
$
|
(1,688
|
)
|
|
$
|
881
|
|
|
$
|
(8,444
|
)
|
Derivatives not designated as hedges:
|
|
|
|
|
|
|
|
|
||||||||
Net gains (losses) recognized in other income (expense), net
|
|
$
|
(41,929
|
)
|
|
$
|
(31,973
|
)
|
|
$
|
(232
|
)
|
|
$
|
34,445
|
|
September 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
|
|
$
|
8,985
|
|
|
$
|
—
|
|
|
$
|
8,985
|
|
|
$
|
(8,985
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
Derivative liabilities
|
|
(61,107
|
)
|
|
—
|
|
|
(61,107
|
)
|
|
8,985
|
|
|
—
|
|
|
(52,122
|
)
|
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
|
)
|
5.
|
ACQUISITION
|
6.
|
INVENTORIES
|
|
|
September 30, 2013
|
|
December 31, 2012
|
||||
Raw materials
|
|
$
|
919,861
|
|
|
$
|
826,545
|
|
Work in process
|
|
540,395
|
|
|
358,525
|
|
||
Finished goods
|
|
485,792
|
|
|
559,912
|
|
||
Total
|
|
$
|
1,946,048
|
|
|
$
|
1,744,982
|
|
7.
|
INTANGIBLE ASSETS AND GOODWILL
|
|
|
September 30, 2013
|
|
December 31, 2012
|
||||
Indefinite-lived intangible assets
|
|
$
|
11,348,900
|
|
|
$
|
10,986,200
|
|
Finite-lived intangible assets
|
|
685,557
|
|
|
750,193
|
|
||
Total intangible assets
|
|
$
|
12,034,457
|
|
|
$
|
11,736,393
|
|
|
|
September 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
|
|
|
|
September 30, 2013
|
|
December 31, 2012
|
||||||||||||
|
|
Gross Carrying
Amount
|
|
Accumulated
Amortization
|
|
Gross Carrying
Amount
|
|
Accumulated
Amortization
|
||||||||
Intangible asset - Ranexa
|
|
$
|
688,400
|
|
|
$
|
176,417
|
|
|
$
|
688,400
|
|
|
$
|
133,119
|
|
Intangible asset - Lexiscan
|
|
262,800
|
|
|
114,774
|
|
|
262,800
|
|
|
95,466
|
|
||||
Other
|
|
42,995
|
|
|
17,447
|
|
|
42,995
|
|
|
15,417
|
|
||||
Total
|
|
$
|
994,195
|
|
|
$
|
308,638
|
|
|
$
|
994,195
|
|
|
$
|
244,002
|
|
Fiscal Year
|
Amount
|
||
2013 (remaining three months)
|
$
|
21,545
|
|
2014
|
92,441
|
|
|
2015
|
97,673
|
|
|
2016
|
107,312
|
|
|
2017
|
116,137
|
|
|
2018
|
124,561
|
|
|
Total
|
$
|
559,669
|
|
Balance at December 31, 2012
|
$
|
1,060,919
|
|
Goodwill resulting from the acquisition of YM
|
127,238
|
|
|
Balance at September 30, 2013
|
$
|
1,188,157
|
|
8.
|
COLLABORATIVE ARRANGEMENTS
|
9.
|
LONG-TERM OBLIGATIONS
|
Type of Borrowing
|
|
Description
|
|
Issue Date
|
|
Due Date
|
|
Interest Rate
|
|
September 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%
|
|
857,322
|
|
|
1,210,213
|
|
||
Convertible Senior
|
|
May 2016 Notes
|
|
July 2010
|
|
May 2016
|
|
1.625%
|
|
1,168,117
|
|
|
1,157,692
|
|
||
Senior Unsecured
|
|
April 2021 Notes
|
|
March 2011
|
|
April 2021
|
|
4.50%
|
|
993,567
|
|
|
992,923
|
|
||
Senior Unsecured
|
|
December 2014 Notes
|
|
December 2011
|
|
December 2014
|
|
2.40%
|
|
749,631
|
|
|
749,394
|
|
||
Senior Unsecured
|
|
December 2016 Notes
|
|
December 2011
|
|
December 2016
|
|
3.05%
|
|
699,268
|
|
|
699,095
|
|
||
Senior Unsecured
|
|
December 2021 Notes
|
|
December 2011
|
|
December 2021
|
|
4.40%
|
|
1,247,644
|
|
|
1,247,428
|
|
||
Senior Unsecured
|
|
December 2041 Notes
|
|
December 2011
|
|
December 2041
|
|
5.65%
|
|
997,866
|
|
|
997,810
|
|
||
Credit Facility
|
|
Five-Year Revolver
|
|
January 2012
|
|
January 2017
|
|
Variable
|
|
600,000
|
|
|
750,000
|
|
||
Total debt, net
|
|
$
|
7,313,415
|
|
|
$
|
8,223,988
|
|
||||||||
Less current portion
|
|
1,457,322
|
|
|
1,169,433
|
|
||||||||||
Total long-term debt, net
|
|
$
|
5,856,093
|
|
|
$
|
7,054,555
|
|
10.
|
COMMITMENTS AND CONTINGENCIES
|
11.
|
STOCK-BASED COMPENSATION
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
September 30,
|
|
September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Cost of goods sold
|
|
$
|
1,823
|
|
|
$
|
1,864
|
|
|
$
|
6,296
|
|
|
$
|
6,084
|
|
Research and development expenses
|
|
27,740
|
|
|
23,236
|
|
|
79,261
|
|
|
162,214
|
|
||||
Selling, general and administrative expenses
|
|
33,010
|
|
|
29,364
|
|
|
94,736
|
|
|
177,237
|
|
||||
Stock-based compensation expense included in total costs and expenses
|
|
62,573
|
|
|
54,464
|
|
|
180,293
|
|
|
345,535
|
|
||||
Income tax effect
|
|
(15,997
|
)
|
|
(15,022
|
)
|
|
(47,958
|
)
|
|
(41,253
|
)
|
||||
Stock-based compensation expense, net of tax
|
|
$
|
46,576
|
|
|
$
|
39,442
|
|
|
$
|
132,335
|
|
|
$
|
304,282
|
|
12.
|
STOCKHOLDERS’ EQUITY
|
|
|
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
|
|
5,155
|
|
|
4,082
|
|
|
(3,371
|
)
|
|
5,866
|
|
||||
Amounts reclassified from accumulated other comprehensive income
|
|
—
|
|
|
(140
|
)
|
|
(2,181
|
)
|
|
(2,321
|
)
|
||||
Net current period other comprehensive income (loss)
|
|
5,155
|
|
|
3,942
|
|
|
(5,552
|
)
|
|
3,545
|
|
||||
Balance at September 30, 2013
|
|
$
|
3,735
|
|
|
$
|
11,444
|
|
|
$
|
(57,249
|
)
|
|
$
|
(42,070
|
)
|
13.
|
SEGMENT INFORMATION
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
September 30,
|
|
September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Antiviral products:
|
|
|
|
|
|
|
|
|
||||||||
Atripla
|
|
$
|
899,669
|
|
|
$
|
865,378
|
|
|
$
|
2,714,850
|
|
|
$
|
2,656,997
|
|
Truvada
|
|
813,652
|
|
|
804,190
|
|
|
2,321,673
|
|
|
2,348,386
|
|
||||
Viread
|
|
231,555
|
|
|
214,909
|
|
|
692,075
|
|
|
622,016
|
|
||||
Complera/Eviplera
|
|
210,736
|
|
|
99,297
|
|
|
547,608
|
|
|
224,386
|
|
||||
Stribild
|
|
143,953
|
|
|
17,511
|
|
|
335,495
|
|
|
17,511
|
|
||||
Hepsera
|
|
20,316
|
|
|
27,319
|
|
|
68,195
|
|
|
82,807
|
|
||||
Emtriva
|
|
6,846
|
|
|
7,229
|
|
|
20,156
|
|
|
21,819
|
|
||||
Total antiviral products
|
|
2,326,727
|
|
|
2,035,833
|
|
|
6,700,052
|
|
|
5,973,922
|
|
||||
Letairis
|
|
135,072
|
|
|
105,054
|
|
|
381,436
|
|
|
293,976
|
|
||||
Ranexa
|
|
115,815
|
|
|
95,066
|
|
|
318,698
|
|
|
273,822
|
|
||||
AmBisome
|
|
97,812
|
|
|
87,448
|
|
|
258,224
|
|
|
255,865
|
|
||||
Other products
|
|
34,226
|
|
|
34,577
|
|
|
102,095
|
|
|
89,975
|
|
||||
Total product sales
|
|
$
|
2,709,652
|
|
|
$
|
2,357,978
|
|
|
$
|
7,760,505
|
|
|
$
|
6,887,560
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||
|
|
September 30,
|
|
September 30,
|
||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||
Cardinal Health, Inc.
|
|
16
|
%
|
|
18
|
%
|
|
18
|
%
|
|
19
|
%
|
McKesson Corp.
|
|
16
|
%
|
|
16
|
%
|
|
16
|
%
|
|
16
|
%
|
AmerisourceBergen Corp.
|
|
15
|
%
|
|
11
|
%
|
|
13
|
%
|
|
11
|
%
|
14.
|
INCOME TAXES
|
ITEM 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
We announced results from a Phase 2 study (Study 102) evaluating an investigational once-daily single tablet regimen (STR) of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg for the treatment of HIV-1 infection. At 48 weeks, the regimen was found to be similar to Stribild based on the percentage of patients with HIV RNA levels less than 50 copies/mL and was associated with more favorable renal and bone safety markers. These results were presented at the 53
rd
Interscience Conference on Antimicrobial Agents and Chemotherapy in Denver.
|
•
|
The European Commission granted marketing authorization for once-daily Tybost (cobicistat 150 mg tablets), a pharmacokinetic enhancer that boosts blood levels of certain HIV medicines. Tybost is indicated as a boosting agent for the HIV protease inhibitors atazanavir 300 mg once daily and darunavir 800 mg once daily as part of antiretroviral combination therapy in adults with HIV-1 infection. This approval allows for the marketing of Tybost in all 28 countries of the European Union.
|
•
|
We submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval to support the use of idelalisib, an investigational, targeted, oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin’s lymphoma (iNHL) for patients with iNHL that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy.
|
|
|
Three Months Ended
|
|
|
|
Nine Months Ended
|
|
|
||||||||||||||
|
|
September 30,
|
|
|
|
September 30,
|
|
|
||||||||||||||
|
|
2013
|
|
2012
|
|
Change
|
|
2013
|
|
2012
|
|
Change
|
||||||||||
Antiviral products:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Atripla
|
|
$
|
899,669
|
|
|
$
|
865,378
|
|
|
4
|
%
|
|
$
|
2,714,850
|
|
|
$
|
2,656,997
|
|
|
2
|
%
|
Truvada
|
|
813,652
|
|
|
804,190
|
|
|
1
|
%
|
|
2,321,673
|
|
|
2,348,386
|
|
|
(1
|
)%
|
||||
Viread
|
|
231,555
|
|
|
214,909
|
|
|
8
|
%
|
|
692,075
|
|
|
622,016
|
|
|
11
|
%
|
||||
Complera/Eviplera
|
|
210,736
|
|
|
99,297
|
|
|
112
|
%
|
|
547,608
|
|
|
224,386
|
|
|
144
|
%
|
||||
Stribild
|
|
143,953
|
|
|
17,511
|
|
|
722
|
%
|
|
335,495
|
|
|
17,511
|
|
|
1,816
|
%
|
||||
Hepsera
|
|
20,316
|
|
|
27,319
|
|
|
(26
|
)%
|
|
68,195
|
|
|
82,807
|
|
|
(18
|
)%
|
||||
Emtriva
|
|
6,846
|
|
|
7,229
|
|
|
(5
|
)%
|
|
20,156
|
|
|
21,819
|
|
|
(8
|
)%
|
||||
Total antiviral products
|
|
2,326,727
|
|
|
2,035,833
|
|
|
14
|
%
|
|
6,700,052
|
|
|
5,973,922
|
|
|
12
|
%
|
||||
Letairis
|
|
135,072
|
|
|
105,054
|
|
|
29
|
%
|
|
381,436
|
|
|
293,976
|
|
|
30
|
%
|
||||
Ranexa
|
|
115,815
|
|
|
95,066
|
|
|
22
|
%
|
|
318,698
|
|
|
273,822
|
|
|
16
|
%
|
||||
AmBisome
|
|
97,812
|
|
|
87,448
|
|
|
12
|
%
|
|
258,224
|
|
|
255,865
|
|
|
1
|
%
|
||||
Other
|
|
34,226
|
|
|
34,577
|
|
|
(1
|
)%
|
|
102,095
|
|
|
89,975
|
|
|
13
|
%
|
||||
Total product sales
|
|
$
|
2,709,652
|
|
|
$
|
2,357,978
|
|
|
15
|
%
|
|
$
|
7,760,505
|
|
|
$
|
6,887,560
|
|
|
13
|
%
|
•
|
Atripla
|
•
|
Truvada
|
•
|
Complera/Eviplera
|
•
|
Stribild
|
|
|
Three Months Ended
|
|
|
|
Nine Months Ended
|
|
|
||||||||||||||
|
|
September 30,
|
|
|
|
September 30,
|
|
|
||||||||||||||
|
|
2013
|
|
2012
|
|
Change
|
|
2013
|
|
2012
|
|
Change
|
||||||||||
Royalty revenues
|
|
$
|
69,779
|
|
|
$
|
63,915
|
|
|
9
|
%
|
|
$
|
310,700
|
|
|
$
|
216,126
|
|
|
44
|
%
|
|
|
Three Months Ended
|
|
|
|
Nine Months Ended
|
|
|
||||||||||||||
|
|
September 30,
|
|
|
|
September 30,
|
|
|
||||||||||||||
|
|
2013
|
|
2012
|
|
Change
|
|
2013
|
|
2012
|
|
Change
|
||||||||||
Total product sales
|
|
$
|
2,709,652
|
|
|
$
|
2,357,978
|
|
|
15
|
%
|
|
$
|
7,760,505
|
|
|
$
|
6,887,560
|
|
|
13
|
%
|
Cost of goods sold
|
|
$
|
681,868
|
|
|
$
|
597,269
|
|
|
14
|
%
|
|
$
|
2,000,979
|
|
|
$
|
1,795,545
|
|
|
11
|
%
|
Product gross margin
|
|
75
|
%
|
|
75
|
%
|
|
|
|
74
|
%
|
|
74
|
%
|
|
|
|
|
Three Months Ended
|
|
|
|
Nine Months Ended
|
|
|
||||||||||||||
|
|
September 30,
|
|
|
|
September 30,
|
|
|
||||||||||||||
(In thousands, except percentages)
|
|
2013
|
|
2012
|
|
Change
|
|
2013
|
|
2012
|
|
Change
|
||||||||||
Research and development
|
|
$
|
546,244
|
|
|
$
|
465,831
|
|
|
17
|
%
|
|
$
|
1,567,778
|
|
|
$
|
1,320,286
|
|
|
19
|
%
|
|
|
Three Months Ended
|
|
|
|
Nine Months Ended
|
|
|
||||||||||||||
|
|
September 30,
|
|
|
|
September 30,
|
|
|
||||||||||||||
(In thousands, except percentages)
|
|
2013
|
|
2012
|
|
Change
|
|
2013
|
|
2012
|
|
Change
|
||||||||||
Selling, general and administrative
|
|
$
|
406,860
|
|
|
$
|
319,583
|
|
|
27
|
%
|
|
$
|
1,186,147
|
|
|
$
|
1,095,209
|
|
|
8
|
%
|
|
|
September 30, 2013
|
|
December 31, 2012
|
||||
Cash, cash equivalents and marketable securities
|
|
$
|
2,755,557
|
|
|
$
|
2,582,086
|
|
Working capital
|
|
$
|
2,072,937
|
|
|
$
|
1,886,327
|
|
|
|
Nine Months Ended
|
||||||
|
|
September 30,
|
||||||
|
|
2013
|
|
2012
|
||||
Cash provided by (used in):
|
|
|
|
|
||||
Operating activities
|
|
$
|
2,378,201
|
|
|
$
|
2,488,988
|
|
Investing activities
|
|
$
|
(470,765
|
)
|
|
$
|
(11,896,124
|
)
|
Financing activities
|
|
$
|
(1,698,882
|
)
|
|
$
|
1,073,197
|
|
ITEM 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
ITEM 4.
|
CONTROLS AND PROCEDURES
|
PART II.
|
OTHER INFORMATION
|
ITEM 1.
|
LEGAL PROCEEDINGS
|
ITEM 1A.
|
RISK FACTORS
|
•
|
As our HIV products are used over a longer period of time in many patients and in combination with other products, and additional studies are conducted, new issues with respect to safety, resistance and interactions with other drugs may arise, which could cause us to provide additional warnings or contraindications on our labels, narrow our approved indications or halt sales of a product, each of which could reduce our revenues.
|
•
|
As our HIV products mature, private insurers and government payers often reduce the amount they will reimburse patients for these products, which increases pressure on us to reduce prices.
|
•
|
A large part of the market for our HIV products consists of patients who are already taking other HIV drugs. If we are not successful in encouraging physicians to change patients' regimens to include our HIV products, the sales of our HIV products will be limited.
|
•
|
As generic HIV products are introduced into major markets, our ability to maintain pricing and market share may be affected. For example, we currently also expect competition from a generic version of Sustiva (efavirenz), a component of our Atripla. Generic versions of efavirenz are now available in Canada and will be made available in Europe in late 2013 and the United States in 2015. This may negatively impact sales of our HIV products. We also expect the launch of dolutegravir, an integrase inhibitor, in the fourth quarter of 2013 by GlaxoSmithKline Inc. (GSK) which could negatively impact sales of our HIV products.
|
•
|
our minimum base rebate amount owed to Medicaid on products reimbursed by Medicaid increased by 8%, and the discounts or rebates we owe to ADAPs and other Public Health Service entities which reimburse or purchase our products also increased by 8%;
|
•
|
we are required to extend rebates to patients receiving our products through Medicaid managed care organizations;
|
•
|
we are required to provide a 50% discount on products sold to patients while they are in the Medicare Part D “donut hole;” and
|
•
|
we, along with other pharmaceutical manufacturers of branded drug products, were required to pay a portion of a new industry fee (also known as the pharmaceutical excise tax) of $2.8 billion for 2012, calculated based on select government sales during the 2010 calendar year as a percentage of total industry government sales.
|
•
|
we are unable to control the resources our corporate partners devote to our programs or products;
|
•
|
disputes may arise with respect to the ownership of rights to technology developed with our corporate partners;
|
•
|
disagreements with our corporate partners could cause delays in, or termination of, the research, development or commercialization of product candidates or result in litigation or arbitration;
|
•
|
contracts with our corporate partners may fail to provide significant protection or may fail to be effectively enforced if one of these partners fails to perform;
|
•
|
our corporate partners have considerable discretion in electing whether to pursue the development of any additional products and may pursue alternative technologies or products either on their own or in collaboration with our competitors;
|
•
|
our corporate partners with marketing rights may choose to pursue competing technologies or to devote fewer resources to the marketing of our products than they do to products of their own development; and
|
•
|
our distributors and our corporate partners may be unable to pay us, particularly in light of current economic conditions.
|
•
|
not provide us with accurate or timely information regarding their inventories, patient data or safety complaints;
|
•
|
not effectively sell or support Cayston or Letairis;
|
•
|
not devote the resources necessary to sell Cayston or Letairis in the volumes and within the time frames that we expect;
|
•
|
not be able to satisfy their financial obligations to us or others; or
|
•
|
cease operations.
|
•
|
obtain patents and licenses to patent rights;
|
•
|
preserve trade secrets;
|
•
|
defend against infringement and efforts to invalidate our patents; and
|
•
|
operate without infringing on the intellectual property of others.
|
ITEM 2.
|
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
|
Total Number of
Shares Purchased
|
|
Average Price Paid per Share
|
|
Total Number of Shares Purchased as Part of Publicly Announced Program
|
(1)
|
Maximum Fair Value of Shares that May Yet Be Purchased Under the Program
|
(1)
|
||||||
July 1 – July 31, 2013
|
75
|
|
|
$
|
57.82
|
|
|
—
|
|
|
$
|
3,847,868
|
|
|
August 1 – August 31, 2013
|
1,166
|
|
|
$
|
59.45
|
|
|
864
|
|
|
$
|
3,796,576
|
|
|
September 1 – September 30, 2013
|
801
|
|
|
$
|
62.62
|
|
|
778
|
|
|
$
|
3,747,874
|
|
|
Total
|
2,042
|
|
(2)
|
$
|
60.64
|
|
|
1,642
|
|
(2)
|
|
|
(1)
|
In January 2011, we announced that our Board authorized a $5.00 billion stock repurchase program, which expires in January 2014.
|
(2)
|
The difference between the total number of shares purchased and the total number of shares purchased as part of publicly announced programs is due to the equivalent value in shares of common stock withheld by us from employee restricted stock awards in order to satisfy our applicable tax withholding obligations.
|
ITEM 3.
|
DEFAULTS UPON SENIOR SECURITIES
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
ITEM 5.
|
OTHER INFORMATION
|
ITEM 6.
|
EXHIBITS
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
√
(1)
|
2.1
|
|
Agreement and Plan of Merger among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc., dated as of March 12, 2009
|
|
|
|
|
|
|
†(2)
|
2.5
|
|
Agreement and Plan of Merger among Registrant, Merger Sub and Pharmasset, Inc., dated as of November 21, 2011
|
|
|
|
|
|
|
*(3)
|
3.1
|
|
Amended and Restated Certificate of Incorporation of Registrant, as amended and restated on May 8, 2013
|
|
|
|
|
|
|
*(4)
|
3.2
|
|
Amended and Restated Bylaws of Registrant, as amended and restated on May 12, 2011
|
|
|
|
|
|
|
|
4.1
|
|
Reference is made to Exhibit 3.1 and Exhibit 3.2
|
|
|
|
|
|
|
*(5)
|
4.2
|
|
Indenture related to the Convertible Senior Notes due 2013 (2013 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 0.625% Convertible Senior Note due 2013), dated April 25, 2006
|
|
|
|
|
|
|
*(6)
|
4.3
|
|
Indenture related to the Convertible Senior Notes due 2014 (2014 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.00% Convertible Senior Note due 2014), dated July 30, 2010
|
|
|
|
|
|
|
*(6)
|
4.4
|
|
Indenture related to the Convertible Senior Notes due 2016 (2016 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.625% Convertible Senior Note due 2016), dated July 30, 2010
|
|
|
|
|
|
|
*(7)
|
4.5
|
|
Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee
|
|
|
|
|
|
|
*(7)
|
4.6
|
|
First Supplemental Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including form of Senior Notes)
|
|
|
|
|
|
|
*(8)
|
4.7
|
|
Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2014 Note, Form of 2016 Note, Form of 2021 Note, Form of 2041 Note)
|
|
|
|
|
|
|
*(9)
|
10.1
|
|
Confirmation of OTC Convertible Note Hedge related to 2013 Notes, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A.
|
|
|
|
|
|
|
*(9)
|
10.2
|
|
Confirmation of OTC Warrant Transaction, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A. for warrants expiring in 2013
|
|
|
|
|
|
|
*(10)
|
10.3
|
|
Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(10)
|
10.4
|
|
Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(10)
|
10.5
|
|
Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(10)
|
10.6
|
|
Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(10)
|
10.7
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014
|
|
|
|
|
|
|
*(10)
|
10.8
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014
|
|
|
|
|
|
|
*(10)
|
10.9
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016
|
|
|
|
|
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
*(10)
|
10.10
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016
|
|
|
|
|
|
|
*(11)
|
10.11
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.12
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.13
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.14
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.15
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014
|
|
|
|
|
|
|
*(11)
|
10.16
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014
|
|
|
|
|
|
|
*(11)
|
10.17
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016
|
|
|
|
|
|
|
*(11)
|
10.18
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016
|
|
|
|
|
|
|
*(11)
|
10.19
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.20
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.21
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.22
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.23
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.24
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.25
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.26
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(12)
|
10.27
|
|
5-Year Revolving Credit Facility Credit Agreement among Registrant and Gilead Biopharmaceutics Ireland Corporation, as Borrowers, Bank of America, N.A., as Administrative Agent, Swing Line Lender and L/C Issuer, certain other lenders parties thereto, Barclays Capital, as Syndication Agent, and Goldman Sachs Bank USA, JPMorgan Chase Bank, N.A., Royal Bank of Canada and Wells Fargo Bank, N.A., as Co-Documentation Agents, dated as of January 12, 2012
|
|
|
|
|
|
|
*(12)
|
10.28
|
|
Parent Guaranty Agreement (5-Year Revolving Credit Facility), dated as of January 12, 2012, by Registrant
|
|
|
|
|
|
|
*(13)
|
10.29
|
|
Gilead Sciences, Inc. 1991 Stock Option Plan, as amended through January 29, 2003
|
|
|
|
|
|
|
*(14)
|
10.30
|
|
Form of option agreements used under the 1991 Stock Option Plan
|
|
|
|
|
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
*(13)
|
10.31
|
|
Gilead Sciences, Inc. 1995 Non-Employee Directors' Stock Option Plan, as amended through January 30, 2002
|
|
|
|
|
|
|
*(15)
|
10.32
|
|
Form of option agreement used under the Gilead Sciences, Inc. 1995 Non-Employee Directors' Stock Option Plan
|
|
|
|
|
|
|
*(3)
|
10.33
|
|
Gilead Sciences, Inc. 2004 Equity Incentive Plan, as amended through May 8, 2013
|
|
|
|
|
|
|
*(16)
|
10.34
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants prior to February 2008)
|
|
|
|
|
|
|
*(17)
|
10.35
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants made February 2008 through April 2009)
|
|
|
|
|
|
|
*(18)
|
10.36
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in May 2009)
|
|
|
|
|
|
|
*(19)
|
10.37
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in February 2010)
|
|
|
|
|
|
|
*(20)
|
10.38
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for 2011 and subsequent year grants)
|
|
|
|
|
|
|
*(17)
|
10.39
|
|
Form of non-employee director stock option agreement used under 2004 Equity Incentive Plan (for grants prior to 2008)
|
|
|
|
|
|
|
*(17)
|
10.40
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for initial grants made in 2008)
|
|
|
|
|
|
|
*(17)
|
10.41
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in May 2008 and through May 2012)
|
|
|
|
|
|
|
*(18)
|
10.42
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants commencing in May 2009 and through May 2012)
|
|
|
|
|
|
|
*(21)
|
10.43
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in May 2013)
|
|
|
|
|
|
|
*(21)
|
10.44
|
|
Form of non-employee director option agreement (non-U.S.) used under 2004 Equity Incentive Plan (for annual grants made in May 2013)
|
|
|
|
|
|
|
*(22)
|
10.45
|
|
Form of restricted stock unit issuance agreement used under 2004 Equity Incentive Plan (for annual grants to non-employee directors in May 2012)
|
|
|
|
|
|
|
*(18)
|
10.46
|
|
Form of restricted stock award agreement used under 2004 Equity Incentive Plan (for annual grants to certain non-employee directors prior to May 2012)
|
|
|
|
|
|
|
*(21)
|
10.47
|
|
Form of restricted stock unit issuance agreement used under 2004 Equity Incentive Plan (for annual grants to non-employee directors commencing in May 2013)
|
|
|
|
|
|
|
*(21)
|
10.48
|
|
Form of restricted stock unit issuance agreement (non-U.S.) used under 2004 Equity Incentive Plan (for annual grants to non-employee directors commencing in May 2013)
|
|
|
|
|
|
|
*(18)
|
10.49
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2009)
|
|
*(19)
|
10.50
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2010)
|
|
|
|
|
|
|
*(20)
|
10.51
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2011)
|
|
|
|
|
|
|
*(23)
|
10.52
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2012)
|
|
|
|
|
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
*(24)
|
10.53
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for TSR Goals in 2013)
|
|
|
|
|
|
|
*(24)
|
10.54
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for Revenue Goals in 2013)
|
|
|
|
|
|
|
*(25)
|
10.55
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made prior to May 2009)
|
|
|
|
|
|
|
*(18)
|
10.56
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers commencing in May 2009)
|
|
|
|
|
|
|
*(26)
|
10.57
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in November 2009)
|
|
|
|
|
|
|
*(20)
|
10.58
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in 2011)
|
|
|
|
|
|
|
*(21)
|
10.59
|
|
Gilead Sciences, Inc. Employee Stock Purchase Plan, amended and restated through May 8, 2013
|
|
|
|
|
|
|
*(21)
|
10.60
|
|
Gilead Sciences, Inc. International Employee Stock Purchase Plan, amended and restated through May 8, 2013
|
|
|
|
|
|
|
*(27)
|
10.61
|
|
Gilead Sciences, Inc. Deferred Compensation Plan-Basic Plan Document
|
|
|
|
|
|
|
*(27)
|
10.62
|
|
Gilead Sciences, Inc. Deferred Compensation Plan-Adoption Agreement
|
|
|
|
|
|
|
*(27)
|
10.63
|
|
Addendum to the Gilead Sciences, Inc. Deferred Compensation Plan
|
|
|
|
|
|
|
*(28)
|
10.64
|
|
Gilead Sciences, Inc. 2005 Deferred Compensation Plan, as amended and restated on October 23, 2008
|
|
|
|
|
|
|
*(23)
|
10.65
|
|
Gilead Sciences, Inc. Severance Plan, as amended on January 26, 2012
|
|
|
|
|
|
|
*(16)
|
10.66
|
|
Gilead Sciences, Inc. Corporate Bonus Plan
|
|
|
|
|
|
|
*(4)
|
10.67
|
|
Amended and Restated Gilead Sciences, Inc. Code Section 162(m) Bonus Plan
|
|
|
|
|
|
|
*(29)
|
10.68
|
|
2013 Base Salaries for the Named Executive Officers
|
|
|
|
|
|
|
*(30)
|
10.69
|
|
Offer Letter dated April 16, 2008 between Registrant and Robin Washington
|
|
|
|
|
|
|
*(14)
|
10.70
|
|
Form of Indemnity Agreement entered into between Registrant and its directors and executive officers
|
|
|
|
|
|
|
*(14)
|
10.71
|
|
Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees
|
|
|
|
|
|
|
*(19)
|
10.72
|
|
Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees (revised in September 2006)
|
|
|
|
|
|
|
(31)
|
10.73
|
|
Amended and Restated Collaboration Agreement by and among Registrant, Gilead Holdings, LLC, Bristol-Myers Squibb Company, E.R. Squibb & Sons, L.L.C., and Bristol-Myers Squibb & Gilead Sciences, LLC, dated September 28, 2006
|
|
|
|
|
|
|
(17)
|
10.74
|
|
Commercialization Agreement by and between Gilead Sciences Limited and Bristol-Myers Squibb Company, dated December 10, 2007
|
|
|
|
|
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
(32)
|
10.75
|
|
Amendment Agreement, dated October 25, 1993, between Registrant, the Institute of Organic Chemistry and Biochemistry (IOCB) and Rega Stichting v.z.w. (REGA), together with the following exhibits: the License Agreement, dated December 15, 1991, between Registrant, IOCB and REGA (the 1991 License Agreement), the License Agreement, dated October 15, 1992, between Registrant, IOCB and REGA (the October 1992 License Agreement) and the License Agreement, dated December 1, 1992, between Registrant, IOCB and REGA (the December 1992 License Agreement)
|
|
|
|
|
|
|
(33)
|
10.76
|
|
Amendment Agreement between Registrant and IOCB/REGA, dated December 27, 2000 amending the 1991 License Agreement and the December 1992 License Agreement
|
|
|
|
|
|
|
(31)
|
10.77
|
|
Sixth Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant, dated August 18, 2006 amending the October 1992 License Agreement and the December 1992 License Agreement
|
|
|
|
|
|
|
+
|
10.78
|
|
Seventh Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant dated July 1, 2013 amending the October 1992 License Agreement and the December 1992 License Agreement
|
|
|
|
|
|
|
(31)
|
10.79
|
|
Development and License Agreement among Registrant and F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., dated September 27, 1996
|
|
|
|
|
|
|
(34)
|
10.80
|
|
First Amendment and Supplement dated November 15, 2005 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996
|
|
|
|
|
|
|
(35)
|
10.81
|
|
Second Amendment dated December 22, 2011 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996
|
|
|
|
|
|
|
+(36)
|
10.82
|
|
Third Amendment dated October 5, 2012 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996
|
|
|
|
|
|
|
(37)
|
10.83
|
|
Exclusive License Agreement between Registrant (as successor to Triangle Pharmaceuticals, Inc.), Glaxo Group Limited, The Wellcome Foundation Limited, Glaxo Wellcome Inc. and Emory University, dated May 6, 1999
|
|
|
|
|
|
|
(38)
|
10.84
|
|
Royalty Sale Agreement by and among Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 18, 2005
|
|
|
|
|
|
|
(38)
|
10.85
|
|
Amended and Restated License Agreement between Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 21, 2005
|
|
|
|
|
|
|
(39)
|
10.86
|
|
License Agreement between Japan Tobacco Inc. and Registrant, dated March 22, 2005
|
|
|
|
|
|
|
(40)
|
10.87
|
|
First Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 19, 2005
|
|
|
|
|
|
|
(40)
|
10.88
|
|
Second Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 17, 2010
|
|
|
|
|
|
|
(40)
|
10.89
|
|
Third Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011
|
|
|
|
|
|
|
(40)
|
10.90
|
|
Fourth Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011
|
|
|
|
|
|
|
(41)
|
10.91
|
|
License Agreement between Registrant (as successor to Myogen, Inc.) and Abbott Deutschland Holding GmbH dated October 8, 2001
|
|
|
|
|
|
|
+(42)
|
10.92
|
|
License Agreement between Registrant (as successor to Myogen, Inc.) and Glaxo Group Limited, dated March 3, 2006
|
|
|
|
|
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
(41)
|
10.93
|
|
License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated March 27, 1996
|
|
|
|
|
|
|
(43)
|
10.94
|
|
First Amendment to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated July 3, 1997
|
|
|
|
|
|
|
(43)
|
10.95
|
|
Amendment No. 2 to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated November 30, 1999
|
|
|
|
|
|
|
(44)
|
10.96
|
|
Amendment No. 4 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated June 20, 2006
|
|
|
|
|
|
|
(35)
|
10.97
|
|
Amendment No. 5 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated December 22, 2011
|
|
|
|
|
|
|
(45)
|
10.98
|
|
License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 16, 2009
|
|
|
|
|
|
|
(40)
|
10.99
|
|
Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 1, 2011
|
|
|
|
|
|
|
+(24)
|
10.100
|
|
Amended and Restated Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated February 7, 2013
|
|
|
|
|
|
|
(46)
|
10.101
|
|
Master Clinical and Commercial Supply Agreement between Gilead World Markets, Limited, Registrant and Patheon Inc., dated January 1, 2003
|
|
|
|
|
|
|
(38)
|
10.102
|
|
Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama), Ltd., dated July 17, 2003
|
|
|
|
|
|
|
(47)
|
10.103
|
|
Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated May 10, 2007
|
|
|
|
|
|
|
(29)
|
10.104
|
|
Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated December 5, 2008
|
|
|
|
|
|
|
(20)
|
10.105
|
|
Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated February 3, 2011
|
|
|
|
|
|
|
(34)
|
10.106
|
|
Restated and Amended Toll Manufacturing Agreement between Gilead Sciences Limited, Registrant and Takeda GmbH (formerly Nycomed GmbH and Altana Pharma Oranienburg GmbH), dated November 7, 2005
|
|
|
|
|
|
|
+(9)
|
10.107
|
|
Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated June 6, 2006
|
|
|
|
|
|
|
+(10)
|
10.108
|
|
Amendment No. 1 to Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated April 30, 2010
|
|
|
|
|
|
|
(48)
|
10.109
|
|
Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012
|
|
|
|
|
|
|
(49)
|
10.110
|
|
Amendment No. 1, dated October 30, 2012, to the Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012
|
|
|
|
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
|
|
|
|
|
|
31.2
|
|
Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
|
|
|
|
|
|
32.1**
|
|
Certifications of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)
|
|
|
|
|
|
|
|
101***
|
|
The following materials from Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Income, (iii) Condensed Consolidated Statements of Comprehensive Income, (iv) Condensed Consolidated Statements of Cash Flows and (v) Notes to Condensed Consolidated Financial Statements.
|
|
|
|
|
|
(1)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on March 12, 2009, and incorporated herein by reference.
|
(2)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on November 25, 2011, and incorporated herein by reference.
|
(3)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 8, 2013, and incorporated herein by reference.
|
(4)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 17, 2011, and incorporated herein by reference.
|
(5)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 25, 2006, and incorporated herein by reference.
|
(6)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on August 2, 2010, and incorporated herein by reference.
|
(7)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 1, 2011, and incorporated herein by reference.
|
(8)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on December 13, 2011, and incorporated herein by reference.
|
(9)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference.
|
(10)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, and incorporated herein by reference.
|
(11)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, and incorporated herein by reference.
|
(12)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on January 17, 2012, and incorporated herein by reference.
|
(13)
|
Filed as an exhibit to Registrant's Registration Statement on Form S-8 (No. 333-102912) filed on January 31, 2003, and incorporated herein by reference.
|
(14)
|
Filed as an exhibit to Registrant's Registration Statement on Form S-1 (No. 33-55680), as amended, and incorporated herein by reference.
|
(15)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K/A for the fiscal year ended December 31, 1998, and incorporated herein by reference.
|
(16)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K/A filed on February 22, 2006, and incorporated herein by reference.
|
(17)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2007, and incorporated herein by reference.
|
(18)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, and incorporated herein by reference.
|
(19)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2009, and incorporated herein by reference.
|
(20)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, and incorporated herein by reference.
|
(21)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, and incorporated herein by reference
|
(22)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, and incorporated herein by reference.
|
(23)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, and incorporated herein by reference.
|
(24)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, and incorporated herein by reference.
|
(25)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K first filed on December 19, 2007, and incorporated herein by reference.
|
(26)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, and incorporated herein by reference.
|
(27)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2001, and incorporated herein by reference.
|
(28)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference.
|
(29)
|
Information is included in Registrant's Current Report on Form 8-K filed on February 5, 2013, and incorporated herein by reference.
|
(30)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, and incorporated herein by reference.
|
(31)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, and incorporated herein by reference.
|
(32)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended March 31, 1994, and incorporated herein by reference.
|
(33)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, and incorporated herein by reference.
|
(34)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and incorporated herein by reference.
|
(35)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and incorporated herein by reference.
|
(36)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference.
|
(37)
|
Filed as an exhibit to Triangle Pharmaceuticals, Inc.'s Quarterly Report on Form 10-Q/A filed on November 3, 1999, and incorporated herein by reference.
|
(38)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, and incorporated herein by reference.
|
(39)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, and incorporated herein by reference.
|
(40)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, and incorporated herein by reference.
|
(41)
|
Filed as an exhibit to Myogen, Inc.'s Registration Statement on Form S-1 (No. 333-108301), as amended, originally filed on August 28, 2003, and incorporated herein by reference.
|
(42)
|
Filed as an exhibit to Myogen, Inc.'s Quarterly Report on Form 10-Q filed on May 9, 2006, and incorporated herein by reference.
|
(43)
|
Filed as an exhibit to CV Therapeutics, Inc.'s Registration Statement on Form S-3 (No. 333-59318), as amended, originally filed on April 20, 2001, and incorporated herein by reference.
|
(44)
|
Filed as an exhibit to CV Therapeutics, Inc.'s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference.
|
(45)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, and incorporated herein by reference.
|
(46)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2003, and incorporated herein by reference.
|
(47)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on August 7, 2007, and incorporated herein by reference.
|
(48)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, and incorporated herein by reference.
|
(49)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference.
|
√
|
The Agreement and Plan of Merger (the Merger Agreement) contains representations and warranties of Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Merger Agreement and may be subject to important qualifications and limitations agreed to by Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. Moreover, some of those representations and warranties may not be accurate or complete as of any specified date, may be subject to a standard of materiality provided for in the Merger Agreement and have been used for the purpose of allocating risk among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. rather than establishing matters as facts.
|
†
|
The Agreement and Plan of Merger (the Pharmasset Merger Agreement) contains representations and warranties of Registrant, Merger Sub and Pharmasset, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Pharmasset Merger Agreement and may be subject to important qualifications and limitations agreed to by Registrant, Merger Sub and Pharmasset, Inc. Moreover, some of those representations and warranties may not be accurate or complete as of any specified date, may be subject to a standard of materiality provided for in the Pharmasset Merger Agreement and have been used for the purpose of allocating risk among Registrant, Merger Sub and Pharmasset, Inc. rather than establishing matters as facts.
|
*
|
Management contract or compensatory plan or arrangement.
|
**
|
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
|
***
|
XBRL information is filed herewith.
|
+
|
Certain confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark). This Exhibit has been filed separately with the Secretary of the Securities and Exchange Commission without the Mark pursuant to Registrant's Application Requesting Confidential Treatment under Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
|
|
|
GILEAD SCIENCES, INC.
|
|
|
(Registrant)
|
|
|
|
Date:
|
October 31, 2013
|
/s/ J
OHN
C. M
ARTIN
|
|
|
John C. Martin, Ph.D.
Chairman and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
Date:
|
October 31, 2013
|
/s/ R
OBIN
L. W
ASHINGTON
|
|
|
Robin L. Washington
Senior Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
√
(1)
|
2.1
|
|
Agreement and Plan of Merger among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc., dated as of March 12, 2009
|
|
|
|
|
|
|
†(2)
|
2.5
|
|
Agreement and Plan of Merger among Registrant, Merger Sub and Pharmasset, Inc., dated as of November 21, 2011
|
|
|
|
|
|
|
*(3)
|
3.1
|
|
Amended and Restated Certificate of Incorporation of Registrant, as amended and restated on May 8, 2013
|
|
|
|
|
|
|
*(4)
|
3.2
|
|
Amended and Restated Bylaws of Registrant, as amended and restated on May 12, 2011
|
|
|
|
|
|
|
|
4.1
|
|
Reference is made to Exhibit 3.1 and Exhibit 3.2
|
|
|
|
|
|
|
*(5)
|
4.2
|
|
Indenture related to the Convertible Senior Notes due 2013 (2013 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 0.625% Convertible Senior Note due 2013), dated April 25, 2006
|
|
|
|
|
|
|
*(6)
|
4.3
|
|
Indenture related to the Convertible Senior Notes due 2014 (2014 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.00% Convertible Senior Note due 2014), dated July 30, 2010
|
|
|
|
|
|
|
*(6)
|
4.4
|
|
Indenture related to the Convertible Senior Notes due 2016 (2016 Notes), between Registrant and Wells Fargo Bank, National Association, as trustee (including form of 1.625% Convertible Senior Note due 2016), dated July 30, 2010
|
|
|
|
|
|
|
*(7)
|
4.5
|
|
Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee
|
|
|
|
|
|
|
*(7)
|
4.6
|
|
First Supplemental Indenture related to Senior Notes, dated as of March 30, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including form of Senior Notes)
|
|
|
|
|
|
|
*(8)
|
4.7
|
|
Second Supplemental Indenture related to Senior Notes, dated as of December 13, 2011, between Registrant and Wells Fargo, National Association, as Trustee (including Form of 2014 Note, Form of 2016 Note, Form of 2021 Note, Form of 2041 Note)
|
|
|
|
|
|
|
*(9)
|
10.1
|
|
Confirmation of OTC Convertible Note Hedge related to 2013 Notes, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A.
|
|
|
|
|
|
|
*(9)
|
10.2
|
|
Confirmation of OTC Warrant Transaction, dated April 19, 2006, as amended and restated as of April 24, 2006, between Registrant and Bank of America, N.A. for warrants expiring in 2013
|
|
|
|
|
|
|
*(10)
|
10.3
|
|
Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(10)
|
10.4
|
|
Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(10)
|
10.5
|
|
Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(10)
|
10.6
|
|
Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(10)
|
10.7
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014
|
|
|
|
|
|
|
*(10)
|
10.8
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014
|
|
|
|
|
|
|
*(10)
|
10.9
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016
|
|
|
|
|
|
|
*(10)
|
10.10
|
|
Confirmation of OTC Warrant Transaction, dated July 26, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
|
|
|
|
|
*(11)
|
10.11
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.12
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.13
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.14
|
|
Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.15
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2014
|
|
|
|
|
|
|
*(11)
|
10.16
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2014
|
|
|
|
|
|
|
*(11)
|
10.17
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and Goldman, Sachs & Co. for warrants expiring in 2016
|
|
|
|
|
|
|
*(11)
|
10.18
|
|
Confirmation of OTC Additional Warrant Transaction, dated August 5, 2010, between Registrant and JPMorgan Chase Bank, National Association for warrants expiring in 2016
|
|
|
|
|
|
|
*(11)
|
10.19
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.20
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.21
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.22
|
|
Amendment to Confirmation of OTC Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.23
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.24
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2014 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(11)
|
10.25
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and Goldman, Sachs & Co.
|
|
|
|
|
|
|
*(11)
|
10.26
|
|
Amendment to Confirmation of OTC Additional Convertible Note Hedge related to 2016 Notes, dated August 30, 2010, between Registrant and JPMorgan Chase Bank, National Association
|
|
|
|
|
|
|
*(12)
|
10.27
|
|
5-Year Revolving Credit Facility Credit Agreement among Registrant and Gilead Biopharmaceutics Ireland Corporation, as Borrowers, Bank of America, N.A., as Administrative Agent, Swing Line Lender and L/C Issuer, certain other lenders parties thereto, Barclays Capital, as Syndication Agent, and Goldman Sachs Bank USA, JPMorgan Chase Bank, N.A., Royal Bank of Canada and Wells Fargo Bank, N.A., as Co-Documentation Agents, dated as of January 12, 2012
|
|
|
|
|
|
|
*(12)
|
10.28
|
|
Parent Guaranty Agreement (5-Year Revolving Credit Facility), dated as of January 12, 2012, by Registrant
|
|
|
|
|
|
|
*(13)
|
10.29
|
|
Gilead Sciences, Inc. 1991 Stock Option Plan, as amended through January 29, 2003
|
|
|
|
|
|
|
*(14)
|
10.30
|
|
Form of option agreements used under the 1991 Stock Option Plan
|
|
|
|
|
|
|
*(13)
|
10.31
|
|
Gilead Sciences, Inc. 1995 Non-Employee Directors' Stock Option Plan, as amended through January 30, 2002
|
|
|
|
|
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
*(15)
|
10.32
|
|
Form of option agreement used under the Gilead Sciences, Inc. 1995 Non-Employee Directors' Stock Option Plan
|
|
|
|
|
|
|
*(3)
|
10.33
|
|
Gilead Sciences, Inc. 2004 Equity Incentive Plan, as amended through May 8, 2013
|
|
|
|
|
|
|
*(16)
|
10.34
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants prior to February 2008)
|
|
|
|
|
|
|
*(17)
|
10.35
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants made February 2008 through April 2009)
|
|
|
|
|
|
|
*(18)
|
10.36
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in May 2009)
|
|
|
|
|
|
|
*(19)
|
10.37
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for grants commencing in February 2010)
|
|
|
|
|
|
|
*(20)
|
10.38
|
|
Form of employee stock option agreement used under 2004 Equity Incentive Plan (for 2011 and subsequent year grants)
|
|
|
|
|
|
|
*(17)
|
10.39
|
|
Form of non-employee director stock option agreement used under 2004 Equity Incentive Plan (for grants prior to 2008)
|
|
|
|
|
|
|
*(17)
|
10.40
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for initial grants made in 2008)
|
|
|
|
|
|
|
*(17)
|
10.41
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in May 2008 and through May 2012)
|
|
|
|
|
|
|
*(18)
|
10.42
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants commencing in May 2009 and through May 2012)
|
|
|
|
|
|
|
*(21)
|
10.43
|
|
Form of non-employee director option agreement used under 2004 Equity Incentive Plan (for annual grants made in May 2013)
|
|
|
|
|
|
|
*(21)
|
10.44
|
|
Form of non-employee director option agreement (non-U.S.) used under 2004 Equity Incentive Plan (for annual grants made in May 2013)
|
|
|
|
|
|
|
*(22)
|
10.45
|
|
Form of restricted stock unit issuance agreement used under 2004 Equity Incentive Plan (for annual grants to non-employee directors in May 2012)
|
|
|
|
|
|
|
*(18)
|
10.46
|
|
Form of restricted stock award agreement used under 2004 Equity Incentive Plan (for annual grants to certain non-employee directors prior to May 2012)
|
|
|
|
|
|
|
*(21)
|
10.47
|
|
Form of restricted stock unit issuance agreement used under 2004 Equity Incentive Plan (for annual grants to non-employee directors commencing in May 2013)
|
|
|
|
|
|
|
*(21)
|
10.48
|
|
Form of restricted stock unit issuance agreement (non-U.S.) used under 2004 Equity Incentive Plan (for annual grants to non-employee directors commencing in May 2013)
|
|
|
|
|
|
|
*(18)
|
10.49
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2009)
|
|
*(19)
|
10.50
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2010)
|
|
|
|
|
|
|
*(20)
|
10.51
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2011)
|
|
|
|
|
|
|
*(23)
|
10.52
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made in 2012)
|
|
|
|
|
|
|
*(24)
|
10.53
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for TSR Goals in 2013)
|
|
|
|
|
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
*(24)
|
10.54
|
|
Form of performance share award agreement used under the 2004 Equity Incentive Plan (for Revenue Goals in 2013)
|
|
|
|
|
|
|
*(25)
|
10.55
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers made prior to May 2009)
|
|
|
|
|
|
|
*(18)
|
10.56
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (for grants to certain executive officers commencing in May 2009)
|
|
|
|
|
|
|
*(26)
|
10.57
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in November 2009)
|
|
|
|
|
|
|
*(20)
|
10.58
|
|
Form of restricted stock unit issuance agreement used under the 2004 Equity Incentive Plan (service-based vesting for certain executive officers commencing in 2011)
|
|
|
|
|
|
|
*(21)
|
10.59
|
|
Gilead Sciences, Inc. Employee Stock Purchase Plan, amended and restated through May 8, 2013
|
|
|
|
|
|
|
*(21)
|
10.60
|
|
Gilead Sciences, Inc. International Employee Stock Purchase Plan, amended and restated through May 8, 2013
|
|
|
|
|
|
|
*(27)
|
10.61
|
|
Gilead Sciences, Inc. Deferred Compensation Plan-Basic Plan Document
|
|
|
|
|
|
|
*(27)
|
10.62
|
|
Gilead Sciences, Inc. Deferred Compensation Plan-Adoption Agreement
|
|
|
|
|
|
|
*(27)
|
10.63
|
|
Addendum to the Gilead Sciences, Inc. Deferred Compensation Plan
|
|
|
|
|
|
|
*(28)
|
10.64
|
|
Gilead Sciences, Inc. 2005 Deferred Compensation Plan, as amended and restated on October 23, 2008
|
|
|
|
|
|
|
*(23)
|
10.65
|
|
Gilead Sciences, Inc. Severance Plan, as amended on January 26, 2012
|
|
|
|
|
|
|
*(16)
|
10.66
|
|
Gilead Sciences, Inc. Corporate Bonus Plan
|
|
|
|
|
|
|
*(4)
|
10.67
|
|
Amended and Restated Gilead Sciences, Inc. Code Section 162(m) Bonus Plan
|
|
|
|
|
|
|
*(29)
|
10.68
|
|
2013 Base Salaries for the Named Executive Officers
|
|
|
|
|
|
|
*(30)
|
10.69
|
|
Offer Letter dated April 16, 2008 between Registrant and Robin Washington
|
|
|
|
|
|
|
*(14)
|
10.70
|
|
Form of Indemnity Agreement entered into between Registrant and its directors and executive officers
|
|
|
|
|
|
|
*(14)
|
10.71
|
|
Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees
|
|
|
|
|
|
|
*(19)
|
10.72
|
|
Form of Employee Proprietary Information and Invention Agreement entered into between Registrant and certain of its officers and key employees (revised in September 2006)
|
|
|
|
|
|
|
(31)
|
10.73
|
|
Amended and Restated Collaboration Agreement by and among Registrant, Gilead Holdings, LLC, Bristol-Myers Squibb Company, E.R. Squibb & Sons, L.L.C., and Bristol-Myers Squibb & Gilead Sciences, LLC, dated September 28, 2006
|
|
|
|
|
|
|
(17)
|
10.74
|
|
Commercialization Agreement by and between Gilead Sciences Limited and Bristol-Myers Squibb Company, dated December 10, 2007
|
|
|
|
|
|
|
(32)
|
10.75
|
|
Amendment Agreement, dated October 25, 1993, between Registrant, the Institute of Organic Chemistry and Biochemistry (IOCB) and Rega Stichting v.z.w. (REGA), together with the following exhibits: the License Agreement, dated December 15, 1991, between Registrant, IOCB and REGA (the 1991 License Agreement), the License Agreement, dated October 15, 1992, between Registrant, IOCB and REGA (the October 1992 License Agreement) and the License Agreement, dated December 1, 1992, between Registrant, IOCB and REGA (the December 1992 License Agreement)
|
|
|
|
|
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
(33)
|
10.76
|
|
Amendment Agreement between Registrant and IOCB/REGA, dated December 27, 2000 amending the 1991 License Agreement and the December 1992 License Agreement
|
|
|
|
|
|
|
(31)
|
10.77
|
|
Sixth Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant, dated August 18, 2006 amending the October 1992 License Agreement and the December 1992 License Agreement
|
|
|
|
|
|
|
+
|
10.78
|
|
Seventh Amendment Agreement to the License Agreement, between IOCB/REGA and Registrant dated July 1, 2013 amending the October 1992 License Agreement and the December 1992 License Agreement
|
|
|
|
|
|
|
(31)
|
10.79
|
|
Development and License Agreement among Registrant and F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., dated September 27, 1996
|
|
|
|
|
|
|
(34)
|
10.80
|
|
First Amendment and Supplement dated November 15, 2005 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996
|
|
|
|
|
|
|
(35)
|
10.81
|
|
Second Amendment dated December 22, 2011 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996
|
|
|
|
|
|
|
+(36)
|
10.82
|
|
Third Amendment dated October 5, 2012 to the Development and Licensing Agreement between Registrant, F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc. dated September 27, 1996
|
|
|
|
|
|
|
(37)
|
10.83
|
|
Exclusive License Agreement between Registrant (as successor to Triangle Pharmaceuticals, Inc.), Glaxo Group Limited, The Wellcome Foundation Limited, Glaxo Wellcome Inc. and Emory University, dated May 6, 1999
|
|
|
|
|
|
|
(38)
|
10.84
|
|
Royalty Sale Agreement by and among Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 18, 2005
|
|
|
|
|
|
|
(38)
|
10.85
|
|
Amended and Restated License Agreement between Registrant, Emory University and Investors Trust & Custodial Services (Ireland) Limited, solely in its capacity as Trustee of Royalty Pharma, dated July 21, 2005
|
|
|
|
|
|
|
(39)
|
10.86
|
|
License Agreement between Japan Tobacco Inc. and Registrant, dated March 22, 2005
|
|
|
|
|
|
|
(40)
|
10.87
|
|
First Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 19, 2005
|
|
|
|
|
|
|
(40)
|
10.88
|
|
Second Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated May 17, 2010
|
|
|
|
|
|
|
(40)
|
10.89
|
|
Third Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011
|
|
|
|
|
|
|
(40)
|
10.90
|
|
Fourth Amendment to License Agreement between Japan Tobacco Inc. and Registrant, dated July 5, 2011
|
|
|
|
|
|
|
(41)
|
10.91
|
|
License Agreement between Registrant (as successor to Myogen, Inc.) and Abbott Deutschland Holding GmbH dated October 8, 2001
|
|
|
|
|
|
|
+(42)
|
10.92
|
|
License Agreement between Registrant (as successor to Myogen, Inc.) and Glaxo Group Limited, dated March 3, 2006
|
|
|
|
|
|
|
(41)
|
10.93
|
|
License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated March 27, 1996
|
|
|
|
|
|
|
(43)
|
10.94
|
|
First Amendment to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated July 3, 1997
|
|
|
|
|
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
(43)
|
10.95
|
|
Amendment No. 2 to License Agreement between Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated November 30, 1999
|
|
|
|
|
|
|
(44)
|
10.96
|
|
Amendment No. 4 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated June 20, 2006
|
|
|
|
|
|
|
(35)
|
10.97
|
|
Amendment No. 5 to License Agreement with Registrant (as successor to CV Therapeutics, Inc.) and Roche Palo Alto LLC (successor in interest by merger to Syntex (U.S.A.) Inc.), dated December 22, 2011
|
|
|
|
|
|
|
(45)
|
10.98
|
|
License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 16, 2009
|
|
|
|
|
|
|
(40)
|
10.99
|
|
Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated July 1, 2011
|
|
|
|
|
|
|
+(24)
|
10.100
|
|
Amended and Restated Second Amendment to License and Collaboration Agreement by and among Registrant, Gilead Sciences Limited and Janssen R&D Ireland (formerly Tibotec Pharmaceuticals), dated February 7, 2013
|
|
|
|
|
|
|
(46)
|
10.101
|
|
Master Clinical and Commercial Supply Agreement between Gilead World Markets, Limited, Registrant and Patheon Inc., dated January 1, 2003
|
|
|
|
|
|
|
(38)
|
10.102
|
|
Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama), Ltd., dated July 17, 2003
|
|
|
|
|
|
|
(47)
|
10.103
|
|
Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated May 10, 2007
|
|
|
|
|
|
|
(29)
|
10.104
|
|
Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated December 5, 2008
|
|
|
|
|
|
|
(20)
|
10.105
|
|
Addendum to Tenofovir Disoproxil Fumarate Manufacturing Supply Agreement by and between Gilead Sciences Limited and PharmaChem Technologies (Grand Bahama) Ltd., dated February 3, 2011
|
|
|
|
|
|
|
(34)
|
10.106
|
|
Restated and Amended Toll Manufacturing Agreement between Gilead Sciences Limited, Registrant and Takeda GmbH (formerly Nycomed GmbH and Altana Pharma Oranienburg GmbH), dated November 7, 2005
|
|
|
|
|
|
|
+(9)
|
10.107
|
|
Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated June 6, 2006
|
|
|
|
|
|
|
+(10)
|
10.108
|
|
Amendment No. 1 to Emtricitabine Manufacturing Supply Agreement between Gilead Sciences Limited and Evonik Degussa GmbH (formerly known as Degussa AG), dated April 30, 2010
|
|
|
|
|
|
|
(48)
|
10.109
|
|
Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012
|
|
|
|
|
|
|
(49)
|
10.110
|
|
Amendment No. 1, dated October 30, 2012, to the Purchase and Sale Agreement and Joint Escrow Instructions between Electronics for Imaging, Inc. and Registrant, dated July 18, 2012
|
|
|
|
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
|
|
|
|
|
|
31.2
|
|
Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended
|
|
|
|
|
|
|
|
32.1**
|
|
Certifications of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)
|
Exhibit
Footnote
|
|
Exhibit
Number
|
|
Description of Document
|
|
|
|
|
|
|
101***
|
|
The following materials from Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, formatted in Extensible Business Reporting Language (XBRL) includes: (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Income, (iii) Condensed Consolidated Statements of Comprehensive Income, (iv) Condensed Consolidated Statements of Cash Flows and (v) Notes to Condensed Consolidated Financial Statements.
|
|
|
|
|
|
(1)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on March 12, 2009, and incorporated herein by reference.
|
(2)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on November 25, 2011, and incorporated herein by reference.
|
(3)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 8, 2013, and incorporated herein by reference.
|
(4)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on May 17, 2011, and incorporated herein by reference.
|
(5)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 25, 2006, and incorporated herein by reference.
|
(6)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on August 2, 2010, and incorporated herein by reference.
|
(7)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on April 1, 2011, and incorporated herein by reference.
|
(8)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on December 13, 2011, and incorporated herein by reference.
|
(9)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference.
|
(10)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, and incorporated herein by reference.
|
(11)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, and incorporated herein by reference.
|
(12)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on January 17, 2012, and incorporated herein by reference.
|
(13)
|
Filed as an exhibit to Registrant's Registration Statement on Form S-8 (No. 333-102912) filed on January 31, 2003, and incorporated herein by reference.
|
(14)
|
Filed as an exhibit to Registrant's Registration Statement on Form S-1 (No. 33-55680), as amended, and incorporated herein by reference.
|
(15)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K/A for the fiscal year ended December 31, 1998, and incorporated herein by reference.
|
(16)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K/A filed on February 22, 2006, and incorporated herein by reference.
|
(17)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2007, and incorporated herein by reference.
|
(18)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, and incorporated herein by reference.
|
(19)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2009, and incorporated herein by reference.
|
(20)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, and incorporated herein by reference.
|
(21)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, and incorporated herein by reference
|
(22)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, and incorporated herein by reference.
|
(23)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, and incorporated herein by reference.
|
(24)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, and incorporated herein by reference.
|
(25)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K first filed on December 19, 2007, and incorporated herein by reference.
|
(26)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, and incorporated herein by reference.
|
(27)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2001, and incorporated herein by reference.
|
(28)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2008, and incorporated herein by reference.
|
(29)
|
Information is included in Registrant's Current Report on Form 8-K filed on February 5, 2013, and incorporated herein by reference.
|
(30)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008, and incorporated herein by reference.
|
(31)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, and incorporated herein by reference.
|
(32)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended March 31, 1994, and incorporated herein by reference.
|
(33)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2000, and incorporated herein by reference.
|
(34)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and incorporated herein by reference.
|
(35)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and incorporated herein by reference.
|
(36)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference.
|
(37)
|
Filed as an exhibit to Triangle Pharmaceuticals, Inc.'s Quarterly Report on Form 10-Q/A filed on November 3, 1999, and incorporated herein by reference.
|
(38)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, and incorporated herein by reference.
|
(39)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, and incorporated herein by reference.
|
(40)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, and incorporated herein by reference.
|
(41)
|
Filed as an exhibit to Myogen, Inc.'s Registration Statement on Form S-1 (No. 333-108301), as amended, originally filed on August 28, 2003, and incorporated herein by reference.
|
(42)
|
Filed as an exhibit to Myogen, Inc.'s Quarterly Report on Form 10-Q filed on May 9, 2006, and incorporated herein by reference.
|
(43)
|
Filed as an exhibit to CV Therapeutics, Inc.'s Registration Statement on Form S-3 (No. 333-59318), as amended, originally filed on April 20, 2001, and incorporated herein by reference.
|
(44)
|
Filed as an exhibit to CV Therapeutics, Inc.'s Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, and incorporated herein by reference.
|
(45)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, and incorporated herein by reference.
|
(46)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2003, and incorporated herein by reference.
|
(47)
|
Filed as an exhibit to Registrant's Current Report on Form 8-K filed on August 7, 2007, and incorporated herein by reference.
|
(48)
|
Filed as an exhibit to Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, and incorporated herein by reference.
|
(49)
|
Filed as an exhibit to Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2012, and incorporated herein by reference.
|
√
|
The Agreement and Plan of Merger (the Merger Agreement) contains representations and warranties of Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Merger Agreement and may be subject to important qualifications and limitations agreed to by Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. Moreover, some of those representations and warranties may not be accurate or complete as of any specified date, may be subject to a standard of materiality provided for in the Merger Agreement and have been used for the purpose of allocating risk among Registrant, Apex Merger Sub, Inc. and CV Therapeutics, Inc. rather than establishing matters as facts.
|
†
|
The Agreement and Plan of Merger (the Pharmasset Merger Agreement) contains representations and warranties of Registrant, Merger Sub and Pharmasset, Inc. made solely to each other as of specific dates. Those representations and warranties were made solely for purposes of the Pharmasset Merger Agreement and may be subject to important qualifications and limitations agreed to by Registrant, Merger Sub and Pharmasset, Inc. Moreover, some of those representations and warranties may not be accurate or complete as of any specified date, may be subject to a standard of materiality provided for in the Pharmasset Merger Agreement and have been used for the purpose of allocating risk among Registrant, Merger Sub and Pharmasset, Inc. rather than establishing matters as facts.
|
*
|
Management contract or compensatory plan or arrangement.
|
**
|
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
|
***
|
XBRL information is filed herewith.
|
+
|
Certain confidential portions of this Exhibit were omitted by means of marking such portions with an asterisk (the Mark). This Exhibit has been filed separately with the Secretary of the Securities and Exchange Commission without the Mark pursuant to Registrant's Application Requesting Confidential Treatment under Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
|
a.
|
Licensed Products containing cidofovir (including Vistide®);
|
b.
|
Licensed Products containing Adefovir, as Adefovir is defined in the December 2000 Letter Agreement (including Hepsera®);
|
c.
|
Licensed Products containing Tenofovir, as Tenofovir is defined in the December 2000 Letter Agreement (including but not limited to Viread®, Truvada®, Atripla®, Complera®, Eviplera®, and Stribild®).
|
a)
|
[*]
of NET SALES of LICENSED PRODUCT containing cidofovir sold by GILEAD and its AFFILIATES and sublicensees, the manufacture, use or sale of which would, but for the LICENSE, infringe either (i) a VALID CLAIM of a LICENSED PATENT or (ii) a Gilead Valid Claim (defined below), in the country of sale, except as set forth in the following sentence. With respect to NET SALES which would be royalty-bearing as set forth in the previous sentence, but as to which the same LICENSED COMPOUND or LICENSED PRODUCT is being sold in such country by any THIRD PARTY except under this Agreement, and as to which GILEAD or IOCB/REGA is not seeking diligently to enforce its LICENSED PATENTS, GILEAD shall pay to IOCB/REGA a total royalty of
[*]
of NET SALES.
|
b)
|
[*]
of NET SALES of LICENSED PRODUCT containing cidofovir sold by GILEAD and its AFFILIATES and sublicensees that is not covered by LICENSED PATENTS or a Gilead Valid Claim but exploits the licensed TECHNICAL INFORMATION and KNOW-HOW.
|
a)
|
[*]
of NET SALES of LICENSED PRODUCT containing Adefovir sold by GILEAD and its AFFILIATES and sublicensees, the manufacture, use or sale of which would, but for the LICENSE, infringe either (i) a VALID CLAIM of a LICENSED PATENT or (ii) a Gilead Valid Claim (defined below), in the country of sale, except as set forth in the following sentence. With respect to NET SALES which would be royalty-bearing as set forth in the previous sentence, but as to which the same LICENSED COMPOUND or LICENSED PRODUCT is being sold in such country by any THIRD PARTY except under this Agreement, and as to which GILEAD or IOCB/REGA is not seeking diligently to enforce its LICENSED PATENTS, GILEAD shall pay to IOCB/REGA a total royalty of
[*]
of NET SALES.
|
b)
|
[*]
on NET SALES of LICENSED PRODUCT containing Adefovir sold by GILEAD and its AFFILIATES and sublicensees that is not covered by LICENSED PATENTS or a Gilead Valid Claim but exploits the licensed TECHNICAL INFORMATION and KNOW-HOW.
|
a)
|
[*]
of NET SALES of LICENSED PRODUCT containing Tenofovir sold by GILEAD and its AFFILIATES and sublicensees, the manufacture, use or sale of which would, but for the LICENSE, infringe either (i) a VALID CLAIM of a LICENSED PATENT or (ii) a Gilead Valid Claim (defined below), in the country of sale, except as set forth in the following sentence. With respect to NET SALES which would be royalty-bearing as set forth in the previous sentence, but as to which the same LICENSED COMPOUND or LICENSED PRODUCT is being sold in such country by any THIRD PARTY except under this Agreement, and as to which GILEAD or IOCB/REGA is not seeking diligently to enforce its LICENSED PATENTS, GILEAD shall pay to IOCB/REGA a total royalty of
[*]
of NET SALES.
|
b)
|
[*]
on NET SALES of LICENSED PRODUCT containing Tenofovir sold by GILEAD and its AFFILIATES and sublicensees that is not covered by LICENSED PATENTS or a Gilead Valid Claim but exploits the licensed TECHNICAL INFORMATION and KNOW-HOW.
|
a.
|
“
[*]
” shall mean the product designated by Gilead as
[*]
.
|
a.
|
“
[*]
” shall mean the product designated by Gilead as
[*]
.
|
b.
|
“
[*]
” shall mean the product designated by Gilead as
[*]
.
|
a)
|
[*]
of NET SALES of LICENSED PRODUCT containing
[*]
sold by GILEAD and its AFFILIATES and sublicensees, the manufacture, use or sale of which would, but for the LICENSE, infringe a VALID CLAIM of a LICENSED PATENT in the country of sale, except as set forth in the following sentence. With respect to NET SALES which would be royalty-bearing as set forth in the previous sentence, but as to which the same LICENSED COMPOUND or LICENSED PRODUCT is being sold in such country by any THIRD PARTY except under this Agreement, and as to which GILEAD or IOCB/REGA is not seeking diligently to enforce its LICENSED PATENTS, GILEAD shall pay to IOCB/REGA a total royalty of
[*]
of NET SALES.
|
b)
|
[*]
of NET SALES of LICENSED PRODUCT containing
[*]
sold by GILEAD and its AFFILIATES and sublicensees that is not covered by LICENSED PATENTS but exploits the licensed TECHNICAL INFORMATION and KNOW-HOW.
|
(a)
|
CALCULATION OF NET SALES FOR COMBINATION PRODUCTS. Net Sales for any COMBINATION PRODUCT for purposes of determining royalties payable under this Agreement for the LICENSED COMPOUND contained in such COMBINATION PRODUCT will be calculated as follows and, where the COMBINATION PRODUCT includes more than one LICENSED COMPOUND, on a LICENSED COMPOUND-by-LICENSED COMPOUND basis:
|
i.
|
Where each API in the COMBINATION PRODUCT is sold separately as a product containing a single API in the relevant country during the relevant calendar quarter and there is a NET SELLING PRICE available for such API sold separately in such country during such quarter, by multiplying actual NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B1+B2+…) where:
|
ii.
|
Where the API in the COMBINATION PRODUCT that is a LICENSED COMPOUND is sold separately and there is a NET SELLING PRICE available for the LICENSED PRODUCT in the COMBINATION PRODUCT in the relevant country during the relevant calendar quarter, but there is no NET SELLING PRICE available for the API(s) in the COMBINATION PRODUCT other than the LICENSED COMPOUND in the relevant country during the relevant calendar quarter, by multiplying actual NET SALES for such COMBINATION PRODUCT by the fraction A/C where ‘A’ shall have the same meaning as in the clause (i), and ‘C’ is the NET SELLING PRICE in the country during the calendar quarter for the COMBINATION PRODUCT.
|
iii.
|
Where there is no NET SELLING PRICE available for the LICENSED COMPOUND in the COMBINATION PRODUCT in the relevant country during the relevant calendar quarter, but the other API(s) in the COMBINATION PRODUCT are sold separately and there is a NET SELLING PRICE available for such API(s) in the relevant country during the relevant calendar quarter, by multiplying actual NET SALES of such COMBINATION PRODUCT by the quantity [1-((B1+B2_...)/C] where each ‘B’ term shall have the same meaning as in clause (i) and ‘C’ is the NET SELLING PRICE in the relevant country during the relevant calendar quarter for the COMBINATION PRODUCT.
|
iv.
|
Where there is no NET SELLING PRICE available for either the LICENSED COMPOUND or the other API(s) in the COMBINATION PRODUCT in a relevant country during a relevant calendar quarter, by multiplying the NET SELLING PRICE of the COMBINATION PRODUCT in the relevant country for the relevant calendar quarter by the fraction A/C where ‘A’ shall mean, during such calendar quarter, the average worldwide NET SELLING PRICE of the LICENSED PRODUCT that contains as its sole API the same LICENSED COMPOUND that is incorporated into the COMBINATION PRODUCT, and ‘C’ is the NET SELLING PRICE of such COMBINATION PRODUCT during such calendar quarter, on an average worldwide basis.
|
v.
|
Where (1) the API in the COMBINATION PRODUCT that is a LICENSED COMPOUND is not sold separately in any country during a relevant calendar quarter, (2) there is no average worldwide NET SELLING PRICE available for the LICENSED PRODUCT that contains as its sole API the same LICENSED COMPOUND that is incorporated into the COMBINATION PRODUCT in the relevant calendar quarter, and (3) there is no NET SELLING PRICE available for the other API(s) in the COMBINATION PRODUCT in a relevant country during the relevant calendar quarter, either (X) by multiplying actual NET SALES of such COMBINATION PRODUCT by the quantity [1-((B1+B2_...)/C] where each ‘B’ term shall have the same meaning as in clause (i) but on an average worldwide basis during the relevant calendar quarter (if an average worldwide value of ‘B’ is available), and ‘C’ is the NET SELLING PRICE in the relevant country during the relevant calendar quarter for the COMBINATION PRODUCT, or (Y) if there is no average worldwide value of ‘B’ available for each of the other API(s) in the COMBINATION PRODUCT during the relevant
|
vi.
|
Gilead agrees to provide IOCB/REGA with supporting information for the purpose of verifying the calculations of NET SALES of COMBINATION PRODUCTS in a manner consistent with Gilead’s past practices and in substantially the form as Exhibit B attached hereto.”
|
8.
|
General
.
Except as expressly provided in this Seventh Amendment Agreement, the License Agreements, as amended previously, shall remain in full force and effect according to their terms.
|
INSTITUTE OF ORGANIC CHEMISTRY AND BIOCHEMISTRY
|
|
REGA INSTITUTE FOR MEDICAL RESEARCH
|
||
By:
|
/s/ Zdenìk Hostomský
|
|
By:
|
/s/ Erik De Clercq
|
|
Dr. Zdenìk Hostomský, Director
|
|
|
Prof. Erik De Clercq
|
Date:
|
July 18, 2013
|
|
Date:
|
July 23, 2013
|
|
|
|
|
|
K.U. LEUVEN RESEARCH AND DEVELOPMENT
|
|
GILEAD SCIENCES, INC.
|
||
By:
|
/s/ Koenraad Debackere
|
|
By:
|
/s/ John F. Milligan
|
|
Prof. Koenraad Debackere, Director
|
|
|
John F. Milligan, Ph.D.
President and Chief Operating Officer |
Date:
|
July 19, 2013
|
|
Date:
|
July 23, 2013
|
|
|
|
|
|
By:
|
/s/ Paul Van Dun
|
|
|
|
|
Paul Van Dun, Director
|
|
|
|
Date:
|
July 19, 2013
|
|
|
|
/s/ J
OHN
C. M
ARTIN
|
John C. Martin, Ph.D.
Chairman and Chief Executive Officer
|
/
S
/ R
OBIN
L. W
ASHINGTON
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Robin L. Washington
Senior Vice President and Chief Financial Officer
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/s/ J
OHN
C. M
ARTIN
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/s/ R
OBIN
L. W
ASHINGTON
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John C. Martin, Ph.D.
Chairman and Chief Executive Officer
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Robin L. Washington
Senior Vice President and Chief Financial Officer
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