Price Graph
Price
Yield
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FORM 10-Q
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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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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
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EXELIXIS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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04-3257395
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(State or Other Jurisdiction of Incorporation or Organization)
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(I.R.S. Employer Identification Number)
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Large accelerated filer
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ý
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Accelerated filer
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¨
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Non-accelerated filer
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¨
(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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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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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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June 30, 2013
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December 31, 2012
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||||
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(unaudited)
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|||||
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ASSETS
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|
||||
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Current assets:
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|
||||
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Cash and cash equivalents
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$
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131,774
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$
|
170,069
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Short-term investments
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220,198
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241,371
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Short-term restricted cash and investments
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12,214
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12,246
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Trade and other receivables
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4,209
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2,751
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Inventory
|
681
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—
|
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||
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Prepaid expenses and other current assets
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5,880
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|
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6,104
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Total current assets
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374,956
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432,541
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||
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Long-term investments
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138,125
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182,311
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Long-term restricted cash and investments
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21,956
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27,964
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|
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Property and equipment, net
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5,650
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6,059
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||
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Goodwill
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63,684
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63,684
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|
||
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Other assets
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7,713
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|
|
8,538
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|
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Total assets
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$
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612,084
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$
|
721,097
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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
|
$
|
3,458
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$
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4,398
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Accrued clinical trial liabilities
|
29,406
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|
|
20,560
|
|
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Accrued compensation and benefits
|
8,127
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|
|
10,375
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|
||
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Other accrued liabilities
|
15,362
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|
|
11,795
|
|
||
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Current portion of convertible notes
|
10,000
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|
|
10,000
|
|
||
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Current portion of loans payable
|
2,546
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|
|
3,170
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|
||
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Current portion of restructuring
|
4,194
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|
|
5,085
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|
||
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Deferred revenue
|
1,507
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|
16,321
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|
||
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Total current liabilities
|
74,600
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|
|
81,704
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|
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Long-term portion of convertible notes
|
242,459
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240,476
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Long-term portion of loans payable
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81,132
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|
82,090
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|
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Long-term portion of restructuring
|
11,679
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14,137
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Other long-term liabilities
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5,882
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6,256
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|
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Total liabilities
|
415,752
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424,663
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|
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Contingencies (Note 9)
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||||
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Stockholders’ equity:
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||||
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Preferred stock, $0.001 par value, 10,000,000 shares authorized and no shares issued
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—
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—
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Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding:
184,104,277 and 183,697,213 shares at June 30, 2013 and December 31, 2012,
respectively
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184
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183
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Additional paid-in capital
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1,557,303
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1,550,345
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|
||
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Accumulated other comprehensive loss
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(263
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)
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(92
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)
|
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Accumulated deficit
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(1,360,892
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)
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(1,254,002
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)
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Total stockholders’ equity
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196,332
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296,434
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Total liabilities and stockholders’ equity
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$
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612,084
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$
|
721,097
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Three Months Ended June 30,
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Six Months Ended June 30,
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||||||||||||
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2013
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2012
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2013
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2012
|
||||||||
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Revenues:
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License and contract revenues
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$
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7,813
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$
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7,813
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$
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15,626
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$
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26,323
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Net product revenues
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4,043
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—
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5,899
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—
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||||
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Total revenues
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11,856
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7,813
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21,525
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26,323
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||||
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Operating expenses:
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Cost of goods sold
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285
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—
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565
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—
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||||
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Research and development
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49,077
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32,610
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81,812
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65,706
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||||
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Selling, general and administrative
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13,180
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6,760
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23,725
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14,665
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|
||||
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Restructuring charge
|
609
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1,166
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|
728
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|
971
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|
||||
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Total operating expenses
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63,151
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40,536
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|
106,830
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81,342
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|
||||
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Loss from operations
|
(51,295
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)
|
|
(32,723
|
)
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(85,305
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)
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(55,019
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)
|
||||
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Other income (expense), net:
|
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|
|
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|
||||||||
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Interest income and other, net
|
373
|
|
|
340
|
|
|
711
|
|
|
500
|
|
||||
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Interest expense
|
(11,239
|
)
|
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(4,092
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)
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(22,296
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)
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(8,096
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)
|
||||
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Total other income (expense), net
|
(10,866
|
)
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(3,752
|
)
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|
(21,585
|
)
|
|
(7,596
|
)
|
||||
|
Loss before income taxes
|
(62,161
|
)
|
|
(36,475
|
)
|
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(106,890
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)
|
|
(62,615
|
)
|
||||
|
Income tax provision
|
—
|
|
|
12
|
|
|
—
|
|
|
23
|
|
||||
|
Net loss
|
$
|
(62,161
|
)
|
|
$
|
(36,487
|
)
|
|
$
|
(106,890
|
)
|
|
$
|
(62,638
|
)
|
|
Net loss per share, basic and diluted
|
$
|
(0.34
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.58
|
)
|
|
$
|
(0.43
|
)
|
|
Shares used in computing basic and diluted net loss per share
|
183,981
|
|
|
148,654
|
|
|
183,861
|
|
|
145,297
|
|
||||
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Net loss
|
$
|
(62,161
|
)
|
|
$
|
(36,487
|
)
|
|
$
|
(106,890
|
)
|
|
$
|
(62,638
|
)
|
|
Other comprehensive income (loss) (1)
|
(365
|
)
|
|
(45
|
)
|
|
(171
|
)
|
|
143
|
|
||||
|
Comprehensive loss
|
$
|
(62,526
|
)
|
|
$
|
(36,532
|
)
|
|
$
|
(107,061
|
)
|
|
$
|
(62,495
|
)
|
|
(1)
|
Other comprehensive income (loss) consisted solely of unrealized gains or losses on available for sale securities arising during the periods presented. There were no reclassification adjustments to net income resulting from realized gains or losses on the sale of securities and there was no income tax expense related to other comprehensive income during those periods.
|
|
|
Six Months Ended June 30,
|
||||||
|
|
2013
|
|
2012
|
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net loss
|
$
|
(106,890
|
)
|
|
$
|
(62,638
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
|
Depreciation and amortization
|
1,628
|
|
|
2,640
|
|
||
|
Stock-based compensation expense
|
5,605
|
|
|
4,322
|
|
||
|
Restructuring credit for property and equipment
|
—
|
|
|
(179
|
)
|
||
|
Accretion of debt discount
|
12,793
|
|
|
4,477
|
|
||
|
Other
|
3,642
|
|
|
2,366
|
|
||
|
Changes in assets and liabilities:
|
|
|
|
||||
|
Other receivables
|
(1,458
|
)
|
|
27,506
|
|
||
|
Inventory
|
(681
|
)
|
|
—
|
|
||
|
Prepaid expenses and other current assets
|
224
|
|
|
(254
|
)
|
||
|
Other assets
|
—
|
|
|
(224
|
)
|
||
|
Accounts payable and other accrued liabilities
|
379
|
|
|
(2,058
|
)
|
||
|
Clinical trial liability
|
8,846
|
|
|
2,259
|
|
||
|
Restructuring liability
|
(3,349
|
)
|
|
(1,995
|
)
|
||
|
Other long-term liabilities
|
(374
|
)
|
|
(286
|
)
|
||
|
Deferred revenue
|
(14,814
|
)
|
|
(26,293
|
)
|
||
|
Net cash used in operating activities
|
(94,449
|
)
|
|
(50,357
|
)
|
||
|
Cash flows from investing activities:
|
|
|
|
||||
|
Purchases of property and equipment
|
(1,402
|
)
|
|
(509
|
)
|
||
|
Proceeds from sale of property and equipment
|
—
|
|
|
859
|
|
||
|
Proceeds from maturities of restricted cash and investments
|
9,868
|
|
|
—
|
|
||
|
Purchase of restricted cash and investments
|
(3,784
|
)
|
|
132
|
|
||
|
Proceeds from maturities of investments
|
209,889
|
|
|
141,104
|
|
||
|
Purchases of investments
|
(147,751
|
)
|
|
(160,221
|
)
|
||
|
Net cash provided by (used in) investing activities
|
66,820
|
|
|
(18,635
|
)
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Proceeds from issuance of common stock, net
|
—
|
|
|
65,036
|
|
||
|
Proceeds from exercise of stock options and warrants
|
22
|
|
|
306
|
|
||
|
Proceeds from employee stock purchase plan
|
894
|
|
|
827
|
|
||
|
Principal payments on debt
|
(11,582
|
)
|
|
(3,294
|
)
|
||
|
Net cash (used in) provided by financing activities
|
(10,666
|
)
|
|
62,875
|
|
||
|
Net decrease in cash and cash equivalents
|
(38,295
|
)
|
|
(6,117
|
)
|
||
|
Cash and cash equivalents at beginning of period
|
170,069
|
|
|
74,257
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
131,774
|
|
|
$
|
68,140
|
|
|
|
Employee
Severance
And Other Benefits
|
|
Facility
Charges
|
|
Asset
Impairment
|
|
Legal and
Other Fees
|
|
Total
|
||||||||||
|
Restructuring (credit) charge
|
$
|
17,677
|
|
|
$
|
11,814
|
|
|
$
|
3,173
|
|
|
$
|
80
|
|
|
$
|
32,744
|
|
|
Cash payments
|
(10,528
|
)
|
|
(3,739
|
)
|
|
—
|
|
|
(10
|
)
|
|
(14,277
|
)
|
|||||
|
Adjustments or non-cash credits
|
(1,626
|
)
|
|
613
|
|
|
(3,341
|
)
|
|
—
|
|
|
(4,354
|
)
|
|||||
|
Proceeds from sale of assets
|
—
|
|
|
—
|
|
|
168
|
|
|
—
|
|
|
168
|
|
|||||
|
Restructuring liability as of December 31, 2010
|
5,523
|
|
|
8,688
|
|
|
—
|
|
|
70
|
|
|
14,281
|
|
|||||
|
Restructuring (credit) charge
|
2,566
|
|
|
8,480
|
|
|
(907
|
)
|
|
(3
|
)
|
|
10,136
|
|
|||||
|
Cash payments
|
(7,366
|
)
|
|
(3,469
|
)
|
|
—
|
|
|
(16
|
)
|
|
(10,851
|
)
|
|||||
|
Adjustments or non-cash credits
|
(717
|
)
|
|
222
|
|
|
(619
|
)
|
|
—
|
|
|
(1,114
|
)
|
|||||
|
Proceeds from sale of assets
|
—
|
|
|
—
|
|
|
1,526
|
|
|
—
|
|
|
1,526
|
|
|||||
|
Restructuring liability as of December 31, 2011
|
6
|
|
|
13,921
|
|
|
—
|
|
|
51
|
|
|
13,978
|
|
|||||
|
Restructuring (credit) charge
|
970
|
|
|
8,276
|
|
|
(47
|
)
|
|
(28
|
)
|
|
9,171
|
|
|||||
|
Cash payments
|
(965
|
)
|
|
(5,299
|
)
|
|
—
|
|
|
(3
|
)
|
|
(6,267
|
)
|
|||||
|
Adjustments or non-cash credits including stock compensation expense
|
(11
|
)
|
|
2,304
|
|
|
(891
|
)
|
|
—
|
|
|
1,402
|
|
|||||
|
Proceeds from sale of assets
|
—
|
|
|
—
|
|
|
938
|
|
|
—
|
|
|
938
|
|
|||||
|
Restructuring liability as of December 31, 2012
|
—
|
|
|
19,202
|
|
|
—
|
|
|
20
|
|
|
19,222
|
|
|||||
|
Restructuring charge
|
263
|
|
|
465
|
|
|
—
|
|
|
—
|
|
|
728
|
|
|||||
|
Cash payments
|
—
|
|
|
(3,955
|
)
|
|
—
|
|
|
—
|
|
|
(3,955
|
)
|
|||||
|
Adjustments or non-cash credits
|
(49
|
)
|
|
(73
|
)
|
|
—
|
|
|
—
|
|
|
(122
|
)
|
|||||
|
Restructuring liability as of
June 30, 2013
|
$
|
214
|
|
|
$
|
15,639
|
|
|
$
|
—
|
|
|
$
|
20
|
|
|
$
|
15,873
|
|
|
|
June 30, 2013
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
As reported:
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents
|
$
|
131,773
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
131,774
|
|
|
Short-term investments
|
220,254
|
|
|
62
|
|
|
(118
|
)
|
|
220,198
|
|
||||
|
Short-term restricted cash and investments
|
12,193
|
|
|
21
|
|
|
—
|
|
|
12,214
|
|
||||
|
Long-term investments
|
138,400
|
|
|
7
|
|
|
(282
|
)
|
|
138,125
|
|
||||
|
Long-term restricted cash and investments
|
21,910
|
|
|
46
|
|
|
—
|
|
|
21,956
|
|
||||
|
Total cash and investments
|
$
|
524,530
|
|
|
$
|
137
|
|
|
$
|
(400
|
)
|
|
$
|
524,267
|
|
|
|
December 31, 2012
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
As reported:
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents
|
$
|
170,070
|
|
|
$
|
—
|
|
|
$
|
(1
|
)
|
|
$
|
170,069
|
|
|
Short-term investments
|
241,391
|
|
|
46
|
|
|
(66
|
)
|
|
241,371
|
|
||||
|
Short-term restricted cash and investments
|
12,242
|
|
|
4
|
|
|
—
|
|
|
12,246
|
|
||||
|
Long-term investments
|
182,407
|
|
|
28
|
|
|
(124
|
)
|
|
182,311
|
|
||||
|
Long-term restricted cash and investments
|
27,943
|
|
|
21
|
|
|
—
|
|
|
27,964
|
|
||||
|
Total cash and investments
|
$
|
634,053
|
|
|
$
|
99
|
|
|
$
|
(191
|
)
|
|
$
|
633,961
|
|
|
|
June 30, 2013
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Cash and money market funds
|
$
|
62,054
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
62,054
|
|
|
Commercial paper
|
87,217
|
|
|
—
|
|
|
(2
|
)
|
|
87,215
|
|
||||
|
Corporate bonds
|
273,748
|
|
|
42
|
|
|
(396
|
)
|
|
273,394
|
|
||||
|
U.S. Treasury and government sponsored enterprises
|
89,493
|
|
|
94
|
|
|
—
|
|
|
89,587
|
|
||||
|
Municipal bonds
|
12,018
|
|
|
1
|
|
|
(2
|
)
|
|
12,017
|
|
||||
|
Total cash and investments
|
$
|
524,530
|
|
|
$
|
137
|
|
|
$
|
(400
|
)
|
|
$
|
524,267
|
|
|
|
December 31, 2012
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Cash and money market funds
|
$
|
81,744
|
|
|
$
|
2
|
|
|
$
|
—
|
|
|
$
|
81,746
|
|
|
Commercial paper
|
167,223
|
|
|
8
|
|
|
—
|
|
|
167,231
|
|
||||
|
Corporate bonds
|
222,106
|
|
|
30
|
|
|
(187
|
)
|
|
221,949
|
|
||||
|
U.S. Treasury and government sponsored enterprises
|
132,933
|
|
|
59
|
|
|
(1
|
)
|
|
132,991
|
|
||||
|
Municipal bonds
|
30,047
|
|
|
—
|
|
|
(3
|
)
|
|
30,044
|
|
||||
|
Total cash and investments
|
$
|
634,053
|
|
|
$
|
99
|
|
|
$
|
(191
|
)
|
|
$
|
633,961
|
|
|
|
Mature within One Year
|
|
After One Year through Two Years
|
|
Fair Value
|
||||||
|
Money market funds
|
$
|
58,934
|
|
|
$
|
—
|
|
|
$
|
58,934
|
|
|
Commercial paper
|
87,215
|
|
|
—
|
|
|
87,215
|
|
|||
|
Corporate bonds
|
176,441
|
|
|
96,953
|
|
|
273,394
|
|
|||
|
U.S. Treasury and government sponsored enterprises
|
71,357
|
|
|
18,230
|
|
|
89,587
|
|
|||
|
Municipal bonds
|
12,017
|
|
|
—
|
|
|
12,017
|
|
|||
|
Total
|
$
|
405,964
|
|
|
$
|
115,183
|
|
|
$
|
521,147
|
|
|
|
June 30, 2013
|
|
December 31, 2012
|
||||
|
Raw materials
|
$
|
75
|
|
|
$
|
—
|
|
|
Work in process
|
537
|
|
|
—
|
|
||
|
Finished goods
|
69
|
|
|
—
|
|
||
|
Total
|
$
|
681
|
|
|
$
|
—
|
|
|
|
June 30, 2013
|
|
December 31, 2012
|
||||
|
Convertible Senior Subordinated Notes due 2019
|
$
|
157,357
|
|
|
$
|
149,800
|
|
|
Secured Convertible Notes due 2015
|
95,102
|
|
|
100,676
|
|
||
|
Silicon Valley Bank term loan
|
80,000
|
|
|
80,000
|
|
||
|
Silicon Valley Bank line of credit
|
3,678
|
|
|
5,260
|
|
||
|
Total debt
|
336,137
|
|
|
335,736
|
|
||
|
Less: current portion
|
(12,546
|
)
|
|
(13,170
|
)
|
||
|
Long-term debt
|
$
|
323,591
|
|
|
$
|
322,566
|
|
|
|
June 30, 2013
|
||
|
Net carrying amount of the liability component
|
$
|
157,357
|
|
|
Unamortized discount of the liability component
|
130,143
|
|
|
|
Face amount of the 2019 Notes
|
$
|
287,500
|
|
|
|
June 30, 2013
|
||||||||||
|
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
|
Money market funds
|
$
|
58,934
|
|
|
$
|
—
|
|
|
$
|
58,934
|
|
|
Commercial paper
|
2,997
|
|
|
84,218
|
|
|
87,215
|
|
|||
|
Corporate bonds
|
7,013
|
|
|
266,381
|
|
|
273,394
|
|
|||
|
U.S. Treasury and government sponsored enterprises
|
30,444
|
|
|
59,143
|
|
|
89,587
|
|
|||
|
Municipal bonds
|
—
|
|
|
12,017
|
|
|
12,017
|
|
|||
|
Total
|
$
|
99,388
|
|
|
$
|
421,759
|
|
|
$
|
521,147
|
|
|
|
December 31, 2012
|
||||||||||
|
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
|
Money market funds
|
$
|
76,050
|
|
|
$
|
—
|
|
|
$
|
76,050
|
|
|
Commercial paper
|
—
|
|
|
167,231
|
|
|
167,231
|
|
|||
|
Corporate bonds
|
—
|
|
|
221,949
|
|
|
221,949
|
|
|||
|
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
132,991
|
|
|
132,991
|
|
|||
|
Municipal bonds
|
—
|
|
|
30,044
|
|
|
30,044
|
|
|||
|
Total
|
$
|
76,050
|
|
|
$
|
552,215
|
|
|
$
|
628,265
|
|
|
|
June 30, 2013
|
|
December 31, 2012
|
||||||||||||
|
|
Carrying
Amount
|
|
Fair Value
|
|
Carrying
Amount
|
|
Fair Value
|
||||||||
|
Convertible Senior Subordinated Notes due 2019
|
$
|
157,357
|
|
|
$
|
279,939
|
|
|
$
|
149,800
|
|
|
$
|
280,111
|
|
|
Silicon Valley Bank term loan
|
$
|
80,000
|
|
|
$
|
79,767
|
|
|
$
|
80,000
|
|
|
$
|
79,542
|
|
|
Silicon Valley Bank Line of Credit
|
$
|
3,678
|
|
|
$
|
3,676
|
|
|
$
|
5,260
|
|
|
$
|
5,253
|
|
|
•
|
When available, we value investments based on quoted prices for those financial instruments, which is a Level 1 input. Our remaining investments are valued using third-party pricing sources, which use observable market prices, interest rates and yield curves observable at commonly quoted intervals of similar assets as observable inputs for pricing, which is a Level 2 input.
|
|
•
|
2019 Notes are valued using a third-party pricing model that is based in part on average trading prices, which is a Level 2 input. The 2019 Notes are not marked-to-market and are shown at their initial fair value less the unamortized discount; the portion of the value allocated to the conversion option is included in Stockholders’ equity in the accompanying Consolidated Balance Sheets.
|
|
•
|
We have estimated the fair value of our other debt instruments, where possible, using the net present value of the payments discounted at an interest rate that is consistent with money-market rates that would have been earned on our non-interest-bearing compensating balances, which is a Level 2 input.
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Research and development expense
|
$
|
1,553
|
|
|
$
|
1,025
|
|
|
$
|
2,960
|
|
|
$
|
2,232
|
|
|
Selling, general and administrative expense
|
1,370
|
|
|
950
|
|
|
2,638
|
|
|
2,047
|
|
||||
|
Total employee stock-based compensation expense
|
$
|
2,923
|
|
|
$
|
1,975
|
|
|
$
|
5,598
|
|
|
$
|
4,279
|
|
|
|
Stock Options
|
||||||||||||||
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Weighted average grant-date fair value
|
$
|
2.56
|
|
|
$
|
2.68
|
|
|
$
|
2.52
|
|
|
$
|
2.75
|
|
|
Risk-free interest rate
|
0.98
|
%
|
|
1.00
|
%
|
|
0.92
|
%
|
|
1.00
|
%
|
||||
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
||||
|
Volatility
|
62
|
%
|
|
65
|
%
|
|
62
|
%
|
|
65
|
%
|
||||
|
Expected life
|
5.6 years
|
|
|
6.0 years
|
|
|
5.5 years
|
|
|
5.8 years
|
|
||||
|
|
Employee Stock Purchase Plan
|
||||||||||||||
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Weighted average grant-date fair value
|
$
|
1.65
|
|
|
$
|
1.58
|
|
|
$
|
1.63
|
|
|
$
|
2.34
|
|
|
Risk-free interest rate
|
0.12
|
%
|
|
0.16
|
%
|
|
0.13
|
%
|
|
0.08
|
%
|
||||
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
||||
|
Volatility
|
67
|
%
|
|
68
|
%
|
|
67
|
%
|
|
68
|
%
|
||||
|
Expected life
|
0.5 years
|
|
|
0.5 years
|
|
|
0.5 years
|
|
|
0.5 years
|
|
||||
|
|
Shares
|
|
Weighted
Average
Exercise Price
|
|
Weighted
Average
Remaining Contractual
Term (Years)
|
|
Aggregate
Intrinsic
Value
|
|||||
|
Options outstanding at December 31, 2012
|
18,448,550
|
|
|
$
|
6.85
|
|
|
|
|
|
||
|
Granted
|
851,130
|
|
|
$
|
4.65
|
|
|
|
|
|
||
|
Exercised
|
(3,884
|
)
|
|
$
|
4.42
|
|
|
|
|
|
||
|
Forfeited
|
(586,964
|
)
|
|
$
|
6.47
|
|
|
|
|
|
||
|
Options outstanding at June 30, 2013
|
18,708,832
|
|
|
$
|
6.76
|
|
|
4.35
|
|
$
|
108
|
|
|
Exercisable at June 30, 2013
|
13,175,393
|
|
|
$
|
7.31
|
|
|
3.63
|
|
$
|
94
|
|
|
|
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
|
Weighted
Average
Remaining
Contractual
Term (Years)
|
|
Aggregate
Intrinsic
Value
|
|||||
|
Awards outstanding at December 31, 2012
|
1,294,621
|
|
|
$
|
6.07
|
|
|
|
|
|
||
|
Awarded
|
87,710
|
|
|
$
|
4.74
|
|
|
|
|
|
||
|
Released
|
(153,747
|
)
|
|
$
|
7.34
|
|
|
|
|
|
||
|
Forfeited
|
(15,208
|
)
|
|
$
|
5.74
|
|
|
|
|
|
||
|
Awards outstanding at June 30, 2013
|
1,213,376
|
|
|
$
|
5.82
|
|
|
1.55
|
|
$
|
5,509
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Numerator:
|
|
|
|
|
|
|
|
||||||||
|
Net loss
|
$
|
(62,161
|
)
|
|
$
|
(36,487
|
)
|
|
$
|
(106,890
|
)
|
|
$
|
(62,638
|
)
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
|
Shares used in computing basic and diluted net loss per share
|
183,981
|
|
|
148,654
|
|
|
183,861
|
|
|
145,297
|
|
||||
|
Net loss per share, basic and diluted
|
$
|
(0.34
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.58
|
)
|
|
$
|
(0.43
|
)
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||
|
Convertible debt
|
54,123
|
|
|
—
|
|
|
54,123
|
|
|
—
|
|
|
Outstanding stock options, unvested RSUs and ESPP contributions
|
18,147
|
|
|
17,477
|
|
|
18,007
|
|
|
16,226
|
|
|
Warrants
|
1,441
|
|
|
1,441
|
|
|
1,441
|
|
|
1,441
|
|
|
Total potentially dilutive shares
|
73,711
|
|
|
18,918
|
|
|
73,571
|
|
|
17,667
|
|
|
|
|
Six Months Ended June 30,
|
||||
|
|
|
2013
|
|
2012
|
||
|
Collaborator:
|
|
|
|
|
||
|
Bristol-Myers Squibb
|
|
73
|
%
|
|
59
|
%
|
|
Merck
|
|
—
|
%
|
|
41
|
%
|
|
Pharmacy:
|
|
|
|
|
||
|
Diplomat Specialty Pharmacy
|
|
26
|
%
|
|
—
|
%
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
License revenues
(1)
|
$
|
4,011
|
|
|
$
|
4,011
|
|
|
$
|
8,022
|
|
|
$
|
18,690
|
|
|
Contract revenues
(2)
|
3,802
|
|
|
3,802
|
|
|
7,604
|
|
|
7,633
|
|
||||
|
Net product revenues
|
4,043
|
|
|
—
|
|
|
5,899
|
|
|
—
|
|
||||
|
Total revenues
|
$
|
11,856
|
|
|
$
|
7,813
|
|
|
$
|
21,525
|
|
|
$
|
26,323
|
|
|
Dollar change
|
$
|
4,043
|
|
|
|
|
$
|
(4,798
|
)
|
|
|
|
|||
|
Percentage change
|
52
|
%
|
|
|
|
(18
|
)%
|
|
|
|
|||||
|
(1)
|
Includes amortization of upfront payments.
|
|
(2)
|
Includes milestone payments.
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Bristol-Myers Squibb
|
7,813
|
|
|
$
|
7,813
|
|
|
$
|
15,626
|
|
|
$
|
15,627
|
|
|
|
Merck
|
—
|
|
|
—
|
|
|
—
|
|
|
10,666
|
|
||||
|
Diplomat Specialty Pharmacy
|
3,767
|
|
|
—
|
|
|
5,623
|
|
|
—
|
|
||||
|
Other
|
276
|
|
|
—
|
|
|
276
|
|
|
30
|
|
||||
|
Total revenues
|
$
|
11,856
|
|
|
$
|
7,813
|
|
|
$
|
21,525
|
|
|
$
|
26,323
|
|
|
Dollar change
|
$
|
4,043
|
|
|
|
|
|
$
|
(4,798
|
)
|
|
|
|||
|
Percentage change
|
52
|
%
|
|
|
|
(18
|
)%
|
|
|
||||||
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Research and development expenses
|
$
|
49,077
|
|
|
$
|
32,610
|
|
|
$
|
81,812
|
|
|
$
|
65,706
|
|
|
Dollar change
|
$
|
16,467
|
|
|
|
|
$
|
16,106
|
|
|
|
||||
|
Percentage change
|
50
|
%
|
|
|
|
25
|
%
|
|
|
||||||
|
•
|
Clinical Trial Costs
— Clinical trial expenses, which include services performed by third-party contract research organizations and other vendors, increased by $15.3 million, or 105%, and $16.6 million, or 57%, respectively. The increase in clinical trial costs was primarily related to clinical trial activities for COMET-1, our phase 3 pivotal trial with the primary endpoint of overall survival in metastatic CRPC, as well as costs incurred in connection with the start-up for our phase 3 trials for metastatic RCC and metastatic HCC.
|
|
•
|
Consulting
— Consulting expenses increased $1.1 million, or 93%, and $1.6 million, or 70%, respectively, primarily as a result of increased outsourcing of development and clinical trial activities.
|
|
•
|
Stock-Based Compensation
— Stock-Based Compensation increased $0.5 million, or 45%, and $0.6 million, or 28%, respectively, primarily as a result of an increase in the number and valuation of new grants, as well as an increase in the participation and valuation of ESPP.
|
|
•
|
General Corporate Costs
— There was a decrease of $0.5 million, or 9%, and $1.2 million, or 11%, respectively, in the allocation of general corporate costs (such as facility costs, property taxes and insurance) to research and development, primarily due to the decrease in drug discovery personnel resulting from the Restructurings.
|
|
•
|
Personnel
— Personnel expense decreased by $0.6 million, or 4%, for the six months ended
June 30, 2013
, primarily due to the reduction in headcount related to the Restructurings.
|
|
•
|
Depreciation and Amortization
— Depreciation and amortization expense decreased by $0.4 million, or 67% and $0.8 million or 58%, respectively, primarily as a result of the impairment and disposition of assets related to the Restructurings and the impact of additional assets becoming fully depreciated during 2012.
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Selling, general and administrative expenses
|
$
|
13,180
|
|
|
$
|
6,760
|
|
|
$
|
23,725
|
|
|
$
|
14,665
|
|
|
Dollar change
|
$
|
6,420
|
|
|
|
|
$
|
9,060
|
|
|
|
||||
|
Percentage change
|
95
|
%
|
|
|
|
62
|
%
|
|
|
||||||
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Restructuring charge
|
$
|
609
|
|
|
$
|
1,166
|
|
|
$
|
728
|
|
|
$
|
971
|
|
|
Dollar change
|
$
|
(557
|
)
|
|
|
|
$
|
(243
|
)
|
|
|
||||
|
Percentage change
|
(48
|
)%
|
|
|
|
(25
|
)%
|
|
|
||||||
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Interest income and other, net
|
$
|
373
|
|
|
$
|
340
|
|
|
$
|
711
|
|
|
$
|
500
|
|
|
Interest expense
|
(11,239
|
)
|
|
(4,092
|
)
|
|
(22,296
|
)
|
|
(8,096
|
)
|
||||
|
Total other expense, net
|
$
|
(10,866
|
)
|
|
$
|
(3,752
|
)
|
|
$
|
(21,585
|
)
|
|
$
|
(7,596
|
)
|
|
Dollar change
|
$
|
(7,114
|
)
|
|
|
|
$
|
(13,989
|
)
|
|
|
||||
|
Percentage change
|
190
|
%
|
|
|
|
184
|
%
|
|
|
||||||
|
|
Six Months Ended June 30,
|
||||||
|
|
2013
|
|
2012
|
||||
|
Net loss
|
$
|
(106,890
|
)
|
|
$
|
(62,638
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities
|
23,668
|
|
|
13,626
|
|
||
|
Changes in operating assets and liabilities
|
(11,227
|
)
|
|
(1,345
|
)
|
||
|
Net cash used in operating activities
|
(94,449
|
)
|
|
(50,357
|
)
|
||
|
Net cash provided by (used in) investing activities
|
66,820
|
|
|
(18,635
|
)
|
||
|
Net cash (used in) provided by financing activities
|
(10,666
|
)
|
|
62,875
|
|
||
|
Net decrease in cash and cash equivalents
|
(38,295
|
)
|
|
(6,117
|
)
|
||
|
Cash and cash equivalents at beginning of period
|
170,069
|
|
|
74,257
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
131,774
|
|
|
$
|
68,140
|
|
|
•
|
the progress and scope of the development and commercialization activities with respect to COMETRIQ (cabozantinib);
|
|
•
|
repayment of the 2019 Notes;
|
|
•
|
repayment of the Deerfield Notes;
|
|
•
|
repayment of our loan from Silicon Valley Bank;
|
|
•
|
the commercial success of COMETRIQ and the revenues we generate;
|
|
•
|
the level of payments received under existing collaboration agreements, licensing agreements and other arrangements;
|
|
•
|
the degree to which we conduct funded development activity on behalf of partners to whom we have out-licensed compounds or programs;
|
|
•
|
whether we enter into new collaboration agreements, licensing agreements or other arrangements (including, in particular, with respect to COMETRIQ) that provide additional capital;
|
|
•
|
our ability to control costs;
|
|
•
|
our ability to remain in compliance with, or amend or cause to be waived, financial covenants contained in agreements with third parties;
|
|
•
|
the amount of our cash and cash equivalents, short- and long-term investments that serve as collateral for bank lines of credit;
|
|
•
|
future clinical trial results;
|
|
•
|
our need to expand our product and clinical development efforts;
|
|
•
|
the cost and timing of regulatory approvals;
|
|
•
|
the cost of clinical and research supplies of our product candidates;
|
|
•
|
our obligation to share U.S. marketing and commercialization costs for cobimetinib (GDC-0973/XL518) under our collaboration with Genentech;
|
|
•
|
our ability to share the costs of our clinical development efforts with third parties;
|
|
•
|
the effect of competing technological and market developments;
|
|
•
|
the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights; and
|
|
•
|
the cost of any acquisitions of or investments in businesses, products and technologies.
|
|
•
|
fund our operations and clinical trials;
|
|
•
|
continue our research and development efforts; and
|
|
•
|
commercialize our product candidates, if any such candidates receive regulatory approval for commercial sale.
|
|
•
|
the progress and scope of the development and commercialization activities with respect to COMETRIQ
®
(cabozantinib);
|
|
•
|
repayment of our
$287.5 million
aggregate principal amount of the 2019 Notes that mature on
August 15, 2019
, unless earlier converted, redeemed or repurchased;
|
|
•
|
repayment of the
$114.0 million
initial principal amount of the Deerfield Notes, for which we will be required to make mandatory prepayments on an annual basis in 2014 and 2015 equal to 15% of specified payments from our collaborative arrangements received during the prior fiscal year, subject to a maximum annual prepayment amount of $27.5 million and, for the payment due in January 2014, a required minimum prepayment amount of $10.0 million, unless we are able to repay them with our common stock, which we are only able to do under specified conditions;
|
|
•
|
repayment of our term loan and line of credit from Silicon Valley Bank, which had an outstanding balance at
June 30, 2013
, of
$83.7 million
;
|
|
•
|
the commercial success of COMETRIQ and the revenues we generate;
|
|
•
|
the level of payments received under existing collaboration agreements, licensing agreements and other arrangements;
|
|
•
|
the degree to which we conduct funded development activity on behalf of partners to whom we have out-licensed compounds or programs;
|
|
•
|
whether we enter into new collaboration agreements, licensing agreements or other arrangements (including, in particular, with respect to COMETRIQ) that provide additional capital;
|
|
•
|
our ability to control costs;
|
|
•
|
our ability to remain in compliance with, or amend or cause to be waived, financial covenants contained in agreements with third parties;
|
|
•
|
the amount of our cash and cash equivalents, short- and long-term investments that serve as collateral for bank lines of credit;
|
|
•
|
future clinical trial results;
|
|
•
|
our need to expand our product and clinical development efforts;
|
|
•
|
the cost and timing of regulatory approvals;
|
|
•
|
the cost of clinical and research supplies of our product candidates;
|
|
•
|
our obligation to share U.S. marketing and commercialization costs for cobimetinib (GDC-0973/XL518) under our collaboration with Genentech;
|
|
•
|
our ability to share the costs of our clinical development efforts with third parties;
|
|
•
|
the effect of competing technological and market developments;
|
|
•
|
the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights; and
|
|
•
|
the cost of any acquisitions of or investments in businesses, products and technologies.
|
|
•
|
making it more difficult for us to meet our payment and other obligations under the 2019 Notes, the Deerfield Notes, our loan and security agreement with Silicon Valley Bank or our other indebtedness;
|
|
•
|
resulting in an event of default if we fail to comply with the financial and other restrictive covenants contained in our debt agreements, which event of default could result in all of our debt becoming immediately due and payable;
|
|
•
|
increasing our vulnerability to adverse economic and industry conditions;
|
|
•
|
subjecting us to the risk of increased sensitivity to interest rate increases on our indebtedness with variable interest rates, including borrowings under our loan and security agreement with Silicon Valley Bank;
|
|
•
|
limiting our ability to obtain additional financing;
|
|
•
|
requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our cash flow available for other purposes, including working capital, capital expenditures, acquisitions and other general corporate purposes;
|
|
•
|
limiting our flexibility in planning for, or reacting to, changes in our business;
|
|
•
|
preventing us from raising funds necessary to purchase the 2019 Notes in the event we are required to do so following a “Fundamental Change” as specified in the indenture governing the 2019 Notes, or to settle conversions of the 2019 Notes in cash;
|
|
•
|
dilution experienced by our existing stockholders as a result of the conversion of the 2019 Notes or the Deerfield Notes into shares of common stock; and
|
|
•
|
placing us at a possible competitive disadvantage with less leveraged competitors and competitors that may have better access to capital resources.
|
|
•
|
the effectiveness, or perceived effectiveness, of COMETRIQ in comparison to competing products;
|
|
•
|
the existence of any significant side effects of COMETRIQ, as well as their severity in comparison to those of any competing products;
|
|
•
|
potential advantages or disadvantages in relation to alternative treatments;
|
|
•
|
the timing of market entry relative to competitive treatments;
|
|
•
|
indications for which COMETRIQ is approved;
|
|
•
|
the ability to offer COMETRIQ for sale at competitive prices;
|
|
•
|
relative convenience and ease of administration;
|
|
•
|
the strength of sales, marketing and distribution support; and
|
|
•
|
sufficient third-party coverage or reimbursement.
|
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology and Clinical Health Act and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;
|
|
•
|
the federal healthcare programs’ Anti-Kickback Law, which constrains our marketing practices, educational programs, pricing policies, and relationships with healthcare providers or other entities, by prohibiting, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or
|
|
•
|
federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;
|
|
•
|
federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
|
•
|
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating efforts;
|
|
•
|
the Foreign Corrupt Practices Act, a U.S. law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals);
|
|
•
|
federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;
|
|
•
|
state and federal government price reporting laws that require us to calculate and report complex pricing metrics to government programs, where such reported priced may be used in the calculation of reimbursement and/or discounts on our marketed drugs (participation in these programs and compliance with the applicable requirements may subject us to potentially significant discounts on our products, increased infrastructure costs, and potentially limit our ability to offer certain marketplace discounts); and
|
|
•
|
state and federal marketing expenditure tracking and reporting laws, which generally require certain types of expenditures in the United States to be tracked and reported (compliance with such requirements may require investment in infrastructure to ensure that tracking is performed properly, and some of these laws result in the public disclosure of various types of payments and relationships, which could potentially have a negative effect on our business and/or increase enforcement scrutiny of our activities).
|
|
•
|
cabozantinib may not prove to be efficacious or may cause, or potentially cause, harmful side effects;
|
|
•
|
negative or inconclusive clinical trial results may require us to conduct further testing or to abandon projects that we had expected to be promising;
|
|
•
|
our competitors may discover or commercialize other compounds or therapies that show significantly improved safety or efficacy compared to cabozantinib;
|
|
•
|
patient registration or enrollment in our clinical testing may be lower than we anticipate, resulting in the delay or cancellation of clinical testing; and
|
|
•
|
regulators or institutional review boards may withhold authorization of, or delay, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or their determination that participating patients are being exposed to unacceptable health risks.
|
|
•
|
the number of patients who ultimately participate in the clinical trial;
|
|
•
|
the duration of patient follow-up that is appropriate in view of the results or required by regulatory authorities;
|
|
•
|
the number of clinical sites included in the trials; and
|
|
•
|
the length of time required to enroll suitable patient subjects.
|
|
•
|
A concern about the ability to maintain blinding of the trial due to differences in toxicity profiles between cabozantinib and mitoxantrone.
|
|
•
|
A view that the assumed magnitude of pain improvement is modest and could represent a placebo effect or be attained with less toxicity by opioid therapy.
|
|
•
|
A view that symptomatic improvement should be supported by evidence of anti-tumor activity, an acceptable safety profile and lack of survival decrement. The FDA also expressed the view that if the effect that we believe cabozantinib will have on pain is mediated by anti-tumor activity, that anti-tumor activity should translate into an improvement in overall survival.
|
|
•
|
A recommendation that if we use pain response as a primary efficacy endpoint, that we conduct two adequate and well-controlled trials to demonstrate effectiveness as, according to the FDA, a conclusion based on two persuasive studies will always be more secure. The FDA advised that for a single randomized trial to support an NDA, the trial must be well designed, well conducted, internally consistent and provide statistically persuasive efficacy findings so that a second trial would be ethically or practically impossible to perform.
|
|
•
|
we may not be able to control the amount of U.S. marketing and commercialization costs for cobimetinib (GDC-0973/XL518) we are obligated to share under our collaboration with Genentech;
|
|
•
|
we are not able to control the amount and timing of resources that our collaborators or potential future collaborators will devote to the development or commercialization of drug candidates or to their marketing and distribution;
|
|
•
|
collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing;
|
|
•
|
disputes may arise between us and our collaborators that result in the delay or termination of the research, development or commercialization of our drug candidates or that result in costly litigation or arbitration that diverts management’s attention and resources;
|
|
•
|
collaborators may experience financial difficulties;
|
|
•
|
collaborators may not be successful in their efforts to obtain regulatory approvals in a timely manner, or at all;
|
|
•
|
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation;
|
|
•
|
business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement;
|
|
•
|
a collaborator could independently move forward with a competing drug candidate developed either independently or in collaboration with others, including our competitors;
|
|
•
|
we may be precluded from entering into additional collaboration arrangements with other parties in an area or field of exclusivity;
|
|
•
|
future collaborators may require us to relinquish some important rights, such as marketing and distribution rights; and
|
|
•
|
collaborations may be terminated (as occurred with respect to cabozantinib and XL281, which were previously subject to our 2008 collaboration agreement with Bristol-Myers Squibb, and with respect to our 2009 discovery collaboration with Sanofi, which was terminated in December 2011) or allowed to expire, which would delay, and may increase the cost of development of, our drug candidates.
|
|
•
|
the progress and scope of our development and commercialization activities;
|
|
•
|
the commercial success of COMETRIQ and the revenues we generate;
|
|
•
|
recognition of upfront licensing or other fees or revenues;
|
|
•
|
payments of non-refundable upfront or licensing fees, or payment for cost-sharing expenses, to third parties;
|
|
•
|
acceptance of our technologies and platforms;
|
|
•
|
the success rate of our efforts leading to milestone payments and royalties;
|
|
•
|
the introduction of new technologies or products by our competitors;
|
|
•
|
the timing and willingness of collaborators to further develop or, if approved, commercialize our product out-licensed to them;
|
|
•
|
our ability to enter into new collaborative relationships;
|
|
•
|
the termination or non-renewal of existing collaborations;
|
|
•
|
the timing and amount of expenses incurred for clinical development and manufacturing of cabozantinib;
|
|
•
|
adjustments to expenses accrued in prior periods based on management’s estimates after the actual level of activity relating to such expenses becomes more certain;
|
|
•
|
the impairment of acquired goodwill and other assets;
|
|
•
|
the impact of the Restructurings; and
|
|
•
|
general and industry-specific economic conditions that may affect our collaborators’ research and development expenditures.
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|
•
|
adverse results or delays in our or our collaborators’ clinical trials;
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|
•
|
announcement of FDA approval or non-approval, or delays in the FDA review process, of cabozantinib or our collaborators’ product candidates or those of our competitors or actions taken by regulatory agencies with respect to our, our collaborators’ or our competitors’ clinical trials;
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|
•
|
the commercial success of COMETRIQ and the revenues we generate;
|
|
•
|
the timing of achievement of our clinical, regulatory, partnering and other milestones, such as the commencement of clinical development, the completion of a clinical trial, the filing for regulatory approval or the establishment of collaborative arrangements for one or more of our out-licensed programs and compounds;
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|
•
|
actions taken by regulatory agencies with respect to cabozantinib or our clinical trials for cabozantinib;
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|
•
|
the announcement of new products by our competitors;
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|
•
|
quarterly variations in our or our competitors’ results of operations;
|
|
•
|
developments in our relationships with our collaborators, including the termination or modification of our agreements;
|
|
•
|
conflicts or litigation with our collaborators;
|
|
•
|
litigation, including intellectual property infringement and product liability lawsuits, involving us;
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|
•
|
failure to achieve operating results projected by securities analysts;
|
|
•
|
changes in earnings estimates or recommendations by securities analysts;
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|
•
|
financing transactions;
|
|
•
|
developments in the biotechnology or pharmaceutical industry;
|
|
•
|
sales of large blocks of our common stock or sales of our common stock by our executive officers, directors and significant stockholders;
|
|
•
|
departures of key personnel or board members;
|
|
•
|
developments concerning current or future collaborations;
|
|
•
|
FDA or international regulatory actions;
|
|
•
|
third-party reimbursement policies;
|
|
•
|
disposition of any of our subsidiaries, technologies or compounds; and
|
|
•
|
general market, economic and political conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
|
|
•
|
a classified Board of Directors;
|
|
•
|
a prohibition on actions by our stockholders by written consent;
|
|
•
|
the inability of our stockholders to call special meetings of stockholders;
|
|
•
|
the ability of our Board of Directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board of Directors;
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•
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limitations on the removal of directors; and
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•
|
advance notice requirements for director nominations and stockholder proposals.
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|
|
EXELIXIS, INC.
|
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August 6, 2013
|
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/s/ F
RANK
K
ARBE
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Date
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|
Frank Karbe
|
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|
Executive Vice President and Chief Financial Officer
|
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(Duly Authorized Officer and Principal Financial and Accounting Officer)
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
|
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
|
3.1
|
|
Amended and Restated Certificate of Incorporation of Exelixis, Inc.
|
|
10-K
|
|
000-30235
|
|
3.1
|
|
3/10/2010
|
|
|
|
3.2
|
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Exelixis, Inc.
|
|
10-K
|
|
000-30235
|
|
3.2
|
|
3/10/2010
|
|
|
|
3.3
|
|
Certificate of Amendment of Amended and Restated Certificate of Incorporation of Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
5/25/2012
|
|
|
|
3.4
|
|
Amended and Restated Bylaws of Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
12/5/2011
|
|
|
|
4.1
|
|
Specimen Common Stock Certificate.
|
|
S-1,
as amended
|
|
333-96335
|
|
4.1
|
|
2/7/2000
|
|
|
|
4.2
|
|
Form of Warrant, dated June 10, 2009, to purchase 500,000 shares of Exelixis, Inc. common stock in favor of Symphony Evolution Holdings LLC.
|
|
10-Q,
as amended
|
|
000-30235
|
|
4.4
|
|
7/30/2009
|
|
|
|
4.3
|
|
Warrant Purchase Agreement, dated June 9, 2005, between Exelixis, Inc. and Symphony Evolution Holdings LLC.
|
|
10-Q
|
|
000-30235
|
|
10.8
|
|
8/5/2010
|
|
|
|
4.4*
|
|
Form Warrant to Purchase Common Stock of Exelixis, Inc. issued or issuable to Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Partners, L.P. and Deerfield International Limited
|
|
8-K
|
|
000-30235
|
|
4.9
|
|
6/9/2008
|
|
|
|
4.5
|
|
Form of Note, dated July 1, 2010, in favor of Deerfield Private Design International, L.P.
|
|
10-Q
|
|
000-30235
|
|
10.1
(Exhibit A-1)
|
|
8/5/2010
|
|
|
|
4.6
|
|
Form of Note, dated July 1, 2010, in favor of Deerfield Private Design Fund, L.P.
|
|
10-Q
|
|
000-30235
|
|
10.1
(Exhibit A-2)
|
|
8/5/2010
|
|
|
|
4.7
|
|
Indenture dated August 14, 2012 by and between Exelixis, Inc. and Wells Fargo Bank, National Association
|
|
8-K
|
|
000-30235
|
|
4.1
|
|
8/14/2012
|
|
|
|
4.8
|
|
First Supplemental Indenture dated August 14, 2012 to Indenture dated August 14, 2012 by and between Exelixis, Inc. and Wells Fargo Bank, National Association
|
|
8-K
|
|
000-30235
|
|
4.2
|
|
8/14/2012
|
|
|
|
4.9
|
|
Form of 4.25% Convertible Senior Subordinated Note due 2019
|
|
8-K
|
|
000-30235
|
|
4.2
(Exhibit A)
|
|
8/14/2012
|
|
|
|
10.1**
|
|
Product Development and Commercialization Agreement, dated as of October 28, 2002, by and between SmithKlineBeecam Corporation and Exelixis, Inc.
|
|
|
|
|
|
|
|
|
|
X
|
|
31.1
|
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
|
|
|
|
|
|
|
|
X
|
|
31.2
|
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
|
|
|
|
|
|
|
|
X
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
|
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
|
32.1‡
|
|
Certification by the Chief Executive Officer and the Chief Financial Officer of Exelixis, Inc., 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).
|
|
|
|
|
|
|
|
|
|
X
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
X
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
|
X
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
|
*
|
Confidential treatment granted for certain portions of this exhibit.
|
|
**
|
Confidential treatment requested for certain portions of this exhibit.
|
|
‡
|
This certification accompanies this Quarterly Report on Form 10-Q, is not deemed filed with the SEC and is not to be incorporated by reference into any filing of Exelixis, Inc. 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 this Quarterly Report on Form 10-Q), irrespective of any general incorporation language contained in such filing.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|