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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||
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Item 1.
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||
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Item 1A.
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||
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Item 2.
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Item 3.
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||
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Item 4.
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||
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Item 5.
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||
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Item 6.
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September 30,
2016 |
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December 31, 2015*
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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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111,219
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$
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141,634
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Short-term investments
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208,462
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25,426
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||
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Trade and other receivables
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91,207
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5,183
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Inventory
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3,292
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2,616
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Prepaid expenses and other current assets
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7,148
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3,806
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||
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Total current assets
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421,328
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178,665
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||
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Long-term investments
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55,817
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83,600
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||
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Long-term restricted cash and investments
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4,150
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2,650
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Property and equipment, net
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1,737
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1,434
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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 long-term assets
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1,774
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2,309
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Total assets
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$
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548,490
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$
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332,342
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LIABILITIES AND STOCKHOLDERS’ DEFICIT
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||||
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Current liabilities:
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|
||||
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Accounts payable
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$
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3,965
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$
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6,401
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Accrued collaboration liability
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18,710
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10,938
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|
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Accrued compensation and benefits
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15,986
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3,629
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||
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Accrued clinical trial liabilities
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14,887
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|
18,071
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|
||
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Current portion of convertible notes
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29,365
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|
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—
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|
||
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Current portion of term loan payable
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80,000
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|
|
—
|
|
||
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Current portion of deferred revenue
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18,939
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|
|
—
|
|
||
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Other accrued liabilities
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19,791
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|
|
13,212
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|
||
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Total current liabilities
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201,643
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|
|
52,251
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|
||
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Long-term portion of convertible notes
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81,493
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337,937
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||
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Long-term portion of term loan payable
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—
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80,000
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Long-term portion of deferred revenue
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232,573
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—
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|
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Other long-term liabilities
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759
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|
|
2,960
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|
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Total liabilities
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516,468
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473,148
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Commitments
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||||
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Stockholders’ equity (deficit):
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||||
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Preferred stock
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—
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—
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Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding:
286,123,166 and 227,960,943 shares at September 30, 2016 and December 31, 2015, respectively |
286
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228
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Additional paid-in capital
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2,050,086
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1,772,123
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Accumulated other comprehensive loss
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(80
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)
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(232
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)
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Accumulated deficit
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(2,018,270
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)
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(1,912,925
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)
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Total stockholders’ equity (deficit)
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32,022
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(140,806
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)
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Total liabilities and stockholders’ equity (deficit)
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$
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548,490
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$
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332,342
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*
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The condensed consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date.
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Three Months Ended September 30,
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Nine Months Ended September 30,
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||||||||||||
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2016
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2015
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2016
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2015
|
||||||||
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Revenues:
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Net product revenues
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$
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42,742
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$
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6,854
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$
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83,459
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$
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24,234
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Royalty, license and contract revenues
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19,452
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3,000
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30,414
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3,000
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||||
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Total revenues
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62,194
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9,854
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113,873
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27,234
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||||
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Operating expenses:
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Cost of goods sold
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2,455
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1,420
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4,700
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2,872
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||||
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Research and development
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20,256
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26,091
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72,166
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72,879
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Selling, general and administrative
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32,463
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17,842
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103,143
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40,162
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||||
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Restructuring (recovery) charge
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(244
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)
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282
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|
871
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1,142
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||||
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Total operating expenses
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54,930
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45,635
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180,880
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117,055
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|
||||
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Income (loss) from operations
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7,264
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|
(35,781
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)
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(67,007
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)
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(89,821
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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
|
3,059
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|
|
276
|
|
|
4,010
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|
146
|
|
||||
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Interest expense
|
(7,834
|
)
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|
(10,037
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)
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(28,575
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)
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(30,501
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)
|
||||
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Loss on extinguishment of debt
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(13,773
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)
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—
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(13,773
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)
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|
—
|
|
||||
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Total other income (expense), net
|
(18,548
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)
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|
(9,761
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)
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|
(38,338
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)
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(30,355
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)
|
||||
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Net loss
|
$
|
(11,284
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)
|
|
$
|
(45,542
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)
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|
$
|
(105,345
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)
|
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$
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(120,176
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)
|
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Net loss per share, basic and diluted
|
$
|
(0.04
|
)
|
|
$
|
(0.21
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)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.59
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)
|
|
Shares used in computing basic and diluted net loss per share
|
256,319
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|
|
217,587
|
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|
238,024
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|
|
203,153
|
|
||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Net loss
|
$
|
(11,284
|
)
|
|
$
|
(45,542
|
)
|
|
$
|
(105,345
|
)
|
|
$
|
(120,176
|
)
|
|
Other comprehensive income (loss) (1)
|
(209
|
)
|
|
133
|
|
|
152
|
|
|
80
|
|
||||
|
Comprehensive loss
|
$
|
(11,493
|
)
|
|
$
|
(45,409
|
)
|
|
$
|
(105,193
|
)
|
|
$
|
(120,096
|
)
|
|
(1)
|
Other comprehensive income (loss) consisted solely of unrealized gains or losses, net on available for sale securities arising during the periods presented. There were no reclassification adjustments to net loss 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.
|
|
|
Nine Months Ended September 30,
|
||||||
|
|
2016
|
|
2015
|
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net loss
|
$
|
(105,345
|
)
|
|
$
|
(120,176
|
)
|
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
||||
|
Depreciation and amortization
|
754
|
|
|
1,063
|
|
||
|
Stock-based compensation expense
|
18,346
|
|
|
15,420
|
|
||
|
Accretion of debt discount and debt issuance costs
|
8,295
|
|
|
14,274
|
|
||
|
Accrual of interest paid in kind
|
5,939
|
|
|
1,890
|
|
||
|
Gain on sale of equity investment
|
(2,494
|
)
|
|
(95
|
)
|
||
|
Loss on extinguishment of debt
|
13,773
|
|
|
—
|
|
||
|
Change in the fair value of warrants
|
—
|
|
|
549
|
|
||
|
Other
|
(1,381
|
)
|
|
1,338
|
|
||
|
Changes in assets and liabilities:
|
|
|
|
||||
|
Trade and other receivables
|
(85,923
|
)
|
|
1,034
|
|
||
|
Inventory
|
(676
|
)
|
|
259
|
|
||
|
Prepaid expenses and other current assets
|
(3,342
|
)
|
|
(1,940
|
)
|
||
|
Other long term assets
|
535
|
|
|
1,832
|
|
||
|
Accounts payable, accrued compensation and benefits, and other accrued liabilities
|
18,816
|
|
|
(14,293
|
)
|
||
|
Accrued collaboration liability
|
7,772
|
|
|
8,400
|
|
||
|
Clinical trial liabilities
|
(3,184
|
)
|
|
(11,757
|
)
|
||
|
Deferred revenue
|
251,512
|
|
|
(2,583
|
)
|
||
|
Other long-term liabilities
|
(815
|
)
|
|
(1,367
|
)
|
||
|
Net cash provided by (used in) operating activities
|
122,582
|
|
|
(106,152
|
)
|
||
|
Cash flows from investing activities:
|
|
|
|
||||
|
Purchases of property and equipment
|
(1,116
|
)
|
|
(114
|
)
|
||
|
Proceeds from sale of property and equipment
|
92
|
|
|
1,300
|
|
||
|
Proceeds from sale of equity investments
|
2,494
|
|
|
95
|
|
||
|
Proceeds from maturities of restricted cash and investments
|
2,650
|
|
|
16,754
|
|
||
|
Purchase of restricted cash and investments
|
(4,150
|
)
|
|
(2,616
|
)
|
||
|
Proceeds from sale of investments
|
2,266
|
|
|
—
|
|
||
|
Proceeds from maturities of investments
|
100,635
|
|
|
130,341
|
|
||
|
Purchases of investments
|
(258,509
|
)
|
|
(119,692
|
)
|
||
|
Net cash (used in) provided by investing activities
|
(155,638
|
)
|
|
26,068
|
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Proceeds from issuance of common stock, net
|
—
|
|
|
145,651
|
|
||
|
Proceeds from exercise of stock options
|
9,296
|
|
|
3,787
|
|
||
|
Proceeds from employee stock purchase plan
|
479
|
|
|
274
|
|
||
|
Principal payments on debt
|
—
|
|
|
(4,381
|
)
|
||
|
Payments on conversion of convertible notes
|
(7,134
|
)
|
|
—
|
|
||
|
Net cash provided by financing activities
|
2,641
|
|
|
145,331
|
|
||
|
Net (decrease) increase in cash and cash equivalents
|
(30,415
|
)
|
|
65,247
|
|
||
|
Cash and cash equivalents at beginning of period
|
141,634
|
|
|
80,395
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
111,219
|
|
|
$
|
145,642
|
|
|
Supplemental cash flow disclosure - non-cash financing activity:
|
|
|
|
||||
|
Issuance of common stock in settlement of convertible notes
|
$
|
285,308
|
|
|
$
|
—
|
|
|
|
Three months ended September 30, 2015
|
|
Nine months ended September 30, 2015
|
|
Year ended December 31,
|
||||||||||||||||||
|
|
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||||||
|
Statements of Operations:
|
|||||||||||||||||||||||
|
Interest expense, overstated by $2,022, $5,920, $7,993, $7,245, $6,568, $2,310 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(10,037
|
)
|
|
$
|
(30,501
|
)
|
|
$
|
(40,680
|
)
|
|
$
|
(41,362
|
)
|
|
$
|
(38,779
|
)
|
|
$
|
(24,778
|
)
|
|
Total other income (expense), net, overstated by $2,022, $5,920, $7,993, $7,245, $6,568, $2,310 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(9,761
|
)
|
|
$
|
(30,355
|
)
|
|
$
|
(40,268
|
)
|
|
$
|
(37,021
|
)
|
|
$
|
(37,556
|
)
|
|
$
|
(22,792
|
)
|
|
Net loss, overstated by $2,022, $5,920, $7,993, $7,245, $6,568, $2,310 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(45,542
|
)
|
|
$
|
(120,176
|
)
|
|
$
|
(161,744
|
)
|
|
$
|
(261,297
|
)
|
|
$
|
(238,192
|
)
|
|
$
|
(145,335
|
)
|
|
Net loss per share, basic and diluted, overstated by $0.01, $0.03, $0.04, $0.04, $0.04, $0.01 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(0.21
|
)
|
|
$
|
(0.59
|
)
|
|
$
|
(0.77
|
)
|
|
$
|
(1.34
|
)
|
|
$
|
(1.29
|
)
|
|
$
|
(0.91
|
)
|
|
Statements of Comprehensive Loss:
|
|||||||||||||||||||||||
|
Comprehensive loss, overstated by $2,022, $5,920, $7,993, $7,245, $6,568, $2,310 for the three and nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(45,409
|
)
|
|
$
|
(120,096
|
)
|
|
$
|
(161,855
|
)
|
|
$
|
(261,564
|
)
|
|
$
|
(237,954
|
)
|
|
$
|
(145,289
|
)
|
|
Statements of Cash Flows
(1)
:
|
|||||||||||||||||||||||
|
Net loss, overstated by $5,920, $7,993, $7,245, $6,568, $2,310 for the nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively
|
Not reported
|
|
$
|
(120,176
|
)
|
|
$
|
(161,744
|
)
|
|
$
|
(261,297
|
)
|
|
$
|
(238,192
|
)
|
|
$
|
(145,335
|
)
|
||
|
Accretion of debt discount and debt issuance costs, overstated by $5,920, $7,993, $7,245, $6,568, $2,310 for the nine months ended September 30, 2015 and the years ended December 31, 2015, 2014, 2013 and 2012, respectively
|
Not reported
|
|
$
|
14,274
|
|
|
$
|
17,041
|
|
|
$
|
22,289
|
|
|
$
|
19,722
|
|
|
$
|
12,442
|
|
||
|
(1)
|
The error did not impact our net cash provided by or used in operating activities, financing activities or investing activities for any of the periods presented.
|
|
|
December 31,
|
||||||||||||||
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||
|
Balance Sheets:
|
|||||||||||||||
|
Long-term portion of convertible notes, understated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
337,937
|
|
|
$
|
223,629
|
|
|
$
|
301,550
|
|
|
$
|
291,828
|
|
|
Liabilities, understated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
473,148
|
|
|
$
|
482,592
|
|
|
$
|
483,452
|
|
|
$
|
476,015
|
|
|
Additional paid-in capital, overstated by $60,618 as of all dates presented
|
$
|
1,772,123
|
|
|
$
|
1,591,782
|
|
|
$
|
1,504,052
|
|
|
$
|
1,489,727
|
|
|
Accumulated deficit, overstated by $24,116, $16,124, $8,879, $2,310 as of December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(1,912,925
|
)
|
|
$
|
(1,751,180
|
)
|
|
$
|
(1,489,883
|
)
|
|
$
|
(1,251,692
|
)
|
|
Stockholders’ (deficit) equity, misstated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(140,806
|
)
|
|
$
|
(159,323
|
)
|
|
$
|
14,499
|
|
|
$
|
238,127
|
|
|
Statements of Stockholders’ (Deficit) Equity:
|
|||||||||||||||
|
Net loss, overstated by $7,993, $7,245, $6,568, $2,310 for the years ended December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(161,744
|
)
|
|
$
|
(261,297
|
)
|
|
$
|
(238,192
|
)
|
|
$
|
(145,335
|
)
|
|
Additional paid-in capital, overstated by $60,618 as of all dates presented
|
$
|
1,772,123
|
|
|
$
|
1,591,782
|
|
|
$
|
1,504,052
|
|
|
$
|
1,489,727
|
|
|
Accumulated deficit, overstated by $24,116, $16,124, $8,879, $2,310 as of December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(1,912,925
|
)
|
|
$
|
(1,751,180
|
)
|
|
$
|
(1,489,883
|
)
|
|
$
|
(1,251,692
|
)
|
|
Stockholders’ (deficit) equity, misstated by $36,502, $44,494, $51,739, $58,307 as of December 31, 2015, 2014, 2013 and 2012, respectively
|
$
|
(140,806
|
)
|
|
$
|
(159,323
|
)
|
|
$
|
14,499
|
|
|
$
|
238,127
|
|
|
|
2010 Restructurings
|
|
2014 Restructuring
|
|
Total
|
||||||
|
Restructuring liability as of December 31, 2015
|
$
|
4,087
|
|
|
$
|
503
|
|
|
$
|
4,590
|
|
|
Restructuring charge
|
862
|
|
|
9
|
|
|
871
|
|
|||
|
Proceeds from sale of assets
|
—
|
|
|
34
|
|
|
34
|
|
|||
|
Cash payments, net
|
(3,774
|
)
|
|
(437
|
)
|
|
(4,211
|
)
|
|||
|
Other items
|
975
|
|
|
(34
|
)
|
|
941
|
|
|||
|
Restructuring liability as of September 30, 2016
|
$
|
2,150
|
|
|
$
|
75
|
|
|
$
|
2,225
|
|
|
|
September 30, 2016
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Cash and cash equivalents
|
$
|
111,219
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
111,219
|
|
|
Short-term investments
|
208,412
|
|
|
70
|
|
|
(20
|
)
|
|
208,462
|
|
||||
|
Long-term investments
|
55,840
|
|
|
28
|
|
|
(51
|
)
|
|
55,817
|
|
||||
|
Long-term restricted cash and investments
|
4,150
|
|
|
—
|
|
|
—
|
|
|
4,150
|
|
||||
|
Total cash and investments
|
$
|
379,621
|
|
|
$
|
98
|
|
|
$
|
(71
|
)
|
|
$
|
379,648
|
|
|
|
December 31, 2015
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Cash and cash equivalents
|
$
|
141,634
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
141,634
|
|
|
Short-term investments
|
25,484
|
|
|
5
|
|
|
(63
|
)
|
|
25,426
|
|
||||
|
Long-term investments
|
83,665
|
|
|
2
|
|
|
(67
|
)
|
|
83,600
|
|
||||
|
Long-term restricted cash and investments
|
2,650
|
|
|
—
|
|
|
—
|
|
|
2,650
|
|
||||
|
Total cash and investments
|
$
|
253,433
|
|
|
$
|
7
|
|
|
$
|
(130
|
)
|
|
$
|
253,310
|
|
|
|
September 30, 2016
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Money market funds
|
$
|
47,148
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
47,148
|
|
|
Commercial paper
|
133,309
|
|
|
—
|
|
|
—
|
|
|
133,309
|
|
||||
|
Corporate bonds
|
124,346
|
|
|
44
|
|
|
(67
|
)
|
|
124,323
|
|
||||
|
U.S. Treasury and government sponsored enterprises
|
61,228
|
|
|
54
|
|
|
(4
|
)
|
|
61,278
|
|
||||
|
Total investments
|
$
|
366,031
|
|
|
$
|
98
|
|
|
$
|
(71
|
)
|
|
$
|
366,058
|
|
|
|
December 31, 2015
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Money market funds
|
$
|
72,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
72,000
|
|
|
Commercial paper
|
78,155
|
|
|
—
|
|
|
—
|
|
|
78,155
|
|
||||
|
Corporate bonds
|
72,205
|
|
|
4
|
|
|
(118
|
)
|
|
72,091
|
|
||||
|
U.S. Treasury and government sponsored enterprises
|
28,434
|
|
|
1
|
|
|
(12
|
)
|
|
28,423
|
|
||||
|
Marketable equity security
|
16
|
|
|
2
|
|
|
—
|
|
|
18
|
|
||||
|
Total investments
|
$
|
250,810
|
|
|
$
|
7
|
|
|
$
|
(130
|
)
|
|
$
|
250,687
|
|
|
|
Mature within One Year
|
|
After One Year through Two Years
|
|
Fair Value
|
||||||
|
Money market funds
|
$
|
47,148
|
|
|
$
|
—
|
|
|
$
|
47,148
|
|
|
Commercial paper
|
133,309
|
|
|
—
|
|
|
133,309
|
|
|||
|
Corporate bonds
|
74,661
|
|
|
49,662
|
|
|
124,323
|
|
|||
|
U.S. Treasury and government sponsored enterprises
|
55,123
|
|
|
6,155
|
|
|
61,278
|
|
|||
|
Total investments
|
$
|
310,241
|
|
|
$
|
55,817
|
|
|
$
|
366,058
|
|
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
|
Raw materials
|
$
|
890
|
|
|
$
|
1,037
|
|
|
Work in process
|
2,540
|
|
|
2,251
|
|
||
|
Finished goods
|
582
|
|
|
583
|
|
||
|
Total
|
4,012
|
|
|
3,871
|
|
||
|
Less: non-current portion included in Other assets
|
(720
|
)
|
|
(1,255
|
)
|
||
|
Inventory
|
$
|
3,292
|
|
|
$
|
2,616
|
|
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
|
Convertible Senior Subordinated Notes due 2019 (“2019 Notes”)
|
$
|
1,865
|
|
|
$
|
235,210
|
|
|
Secured Convertible Notes due 2018 (“Deerfield Notes”)
|
108,993
|
|
|
102,727
|
|
||
|
Term loan payable
|
80,000
|
|
|
80,000
|
|
||
|
Total debt
|
190,858
|
|
|
417,937
|
|
||
|
Less: current portion
|
(109,365
|
)
|
|
—
|
|
||
|
Long-term debt
|
$
|
81,493
|
|
|
$
|
417,937
|
|
|
|
September 30,
2016 |
|
December 31,
2015 |
||||
|
Net carrying amount of the liability component
|
$
|
1,865
|
|
|
$
|
235,210
|
|
|
Unamortized discount of the liability component
|
327
|
|
|
52,290
|
|
||
|
Face amount of the 2019 Notes
|
$
|
2,192
|
|
|
$
|
287,500
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Stated coupon interest
|
$
|
1,683
|
|
|
$
|
3,054
|
|
|
$
|
7,793
|
|
|
$
|
9,164
|
|
|
Amortization of debt discount and debt issuance costs
|
1,763
|
|
|
2,929
|
|
|
7,968
|
|
|
8,585
|
|
||||
|
Total interest expense
|
$
|
3,446
|
|
|
$
|
5,983
|
|
|
$
|
15,761
|
|
|
$
|
17,749
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Stated coupon interest paid in cash
|
$
|
2,031
|
|
|
$
|
1,891
|
|
|
$
|
5,939
|
|
|
$
|
4,866
|
|
|
Amortization of debt discount, debt issuance costs and accrual of interest paid in kind
|
2,152
|
|
|
1,959
|
|
|
6,266
|
|
|
7,279
|
|
||||
|
Total interest expense
|
$
|
4,183
|
|
|
$
|
3,850
|
|
|
$
|
12,205
|
|
|
$
|
12,145
|
|
|
|
September 30, 2016
|
||||||||||
|
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
|
Money market funds
|
$
|
47,148
|
|
|
$
|
—
|
|
|
$
|
47,148
|
|
|
Commercial paper
|
—
|
|
|
133,309
|
|
|
133,309
|
|
|||
|
Corporate bonds
|
—
|
|
|
124,323
|
|
|
124,323
|
|
|||
|
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
61,278
|
|
|
61,278
|
|
|||
|
Total financial assets
|
$
|
47,148
|
|
|
$
|
318,910
|
|
|
$
|
366,058
|
|
|
|
December 31, 2015
|
||||||||||
|
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
|
Money market funds
|
$
|
72,000
|
|
|
$
|
—
|
|
|
$
|
72,000
|
|
|
Commercial paper
|
—
|
|
|
78,155
|
|
|
78,155
|
|
|||
|
Corporate bonds
|
—
|
|
|
72,091
|
|
|
72,091
|
|
|||
|
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
28,423
|
|
|
28,423
|
|
|||
|
Marketable equity securities
|
18
|
|
|
—
|
|
|
18
|
|
|||
|
Total financial assets
|
$
|
72,018
|
|
|
$
|
178,669
|
|
|
$
|
250,687
|
|
|
|
September 30, 2016
|
|
December 31, 2015
|
||||||||||||
|
|
Carrying
Amount
|
|
Fair Value
|
|
Carrying
Amount
|
|
Fair Value
|
||||||||
|
2019 Notes
|
$
|
1,865
|
|
|
$
|
5,277
|
|
|
$
|
235,210
|
|
|
$
|
336,260
|
|
|
Deerfield Notes
|
$
|
108,993
|
|
|
$
|
110,806
|
|
|
$
|
102,727
|
|
|
$
|
101,096
|
|
|
Term loan payable
|
$
|
80,000
|
|
|
$
|
79,828
|
|
|
$
|
80,000
|
|
|
$
|
79,815
|
|
|
•
|
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.
|
|
•
|
On August 24, 2016, we announced the redemption of
$48.1 million
of the 2019 Notes, representing all remaining 2019 Notes outstanding. As of September 30, 2016, the 2019 Notes were convertible into shares of our common stock, plus cash in lieu of any fractional share, at a conversion rate of
188.2353
shares of common stock per
$1,000
principal amount of the 2019 Notes at any time before close of business on October 31, 2016. Following our issuance of the notice of redemption of the 2019 Notes, the third-party pricing source we historically used to value the 2019 Notes was no longer available. Based on the terms of the redemption and the related conversion feature, we estimated that the value of the shares issuable pursuant to a conversion by the holder approximates the fair value of the 2019 Notes, which represents a Level 3 input.
|
|
•
|
We estimate the fair value of our other debt instruments, where possible, using the net present value of the payments. For the term loan, we use an interest rate that is consistent with money-market rates that would have been earned on our non-interest-bearing compensating balances as our discount rate, which is a Level 2 input. For the Deerfield Notes, we used a discount rate of
15%
, which we estimate as our current borrowing rate for similar debt as of
September 30, 2016
, which is a Level 3 input.
|
|
•
|
The settlement consideration comprises, in part, shares of our Common Stock. The fair value of our Common Stock was determined based on the closing market price of our Common Stock on the various settlement dates of the conversions, which are level 1 inputs;
|
|
•
|
The carrying value of the remaining settlement consideration, which includes cash and the forgiveness of the repayment of certain prior interest payments, approximates fair value;
|
|
•
|
We estimated the fair value of the liability component of the 2019 Notes using the net present value of estimated future cash flows through maturity. We used a discount rate of
9.50%
, which we estimate as our current borrowing rate for straight debt as of
September 30, 2016
, which is a Level 3 input.
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Research and development expense
|
$
|
1,165
|
|
|
$
|
6,676
|
|
|
$
|
7,894
|
|
|
$
|
8,049
|
|
|
Selling, general and administrative expense
|
2,438
|
|
|
5,350
|
|
|
10,452
|
|
|
7,371
|
|
||||
|
Total employee stock-based compensation expense
|
$
|
3,603
|
|
|
$
|
12,026
|
|
|
$
|
18,346
|
|
|
$
|
15,420
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Stock options
|
$
|
8.59
|
|
|
$
|
3.92
|
|
|
$
|
4.31
|
|
|
$
|
2.51
|
|
|
ESPP
|
$
|
1.51
|
|
|
$
|
1.26
|
|
|
$
|
1.65
|
|
|
$
|
0.97
|
|
|
|
Stock Options
|
||||||||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
|
Risk-free interest rate
|
1.07
|
%
|
|
1.18
|
%
|
|
1.09
|
%
|
|
1.20
|
%
|
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Volatility
|
76
|
%
|
|
88
|
%
|
|
76
|
%
|
|
93
|
%
|
|
Expected life
|
4.5 years
|
|
|
4.6 years
|
|
|
4.4 years
|
|
|
4.5 years
|
|
|
|
Employee Stock Purchase Plan
|
||||||||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
|
Risk-free interest rate
|
0.37
|
%
|
|
0.06
|
%
|
|
0.39
|
%
|
|
0.09
|
%
|
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
Volatility
|
63
|
%
|
|
107
|
%
|
|
66
|
%
|
|
101
|
%
|
|
Expected life
|
6 months
|
|
|
6 months
|
|
|
6 months
|
|
|
6 months
|
|
|
|
Shares
|
|
Weighted
Average
Exercise Price
|
|
Weighted
Average
Remaining Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
Options outstanding at December 31, 2015
|
27,425,854
|
|
|
$
|
4.22
|
|
|
|
|
|
||
|
Granted
|
3,771,250
|
|
|
$
|
7.35
|
|
|
|
|
|
||
|
Exercised
|
(3,360,248
|
)
|
|
$
|
2.81
|
|
|
|
|
|
||
|
Forfeited
|
(307,601
|
)
|
|
$
|
4.67
|
|
|
|
|
|
||
|
Expired
|
(80,516
|
)
|
|
$
|
10.49
|
|
|
|
|
|
||
|
Options outstanding at September 30, 2016
|
27,448,739
|
|
|
$
|
4.80
|
|
|
4.58 years
|
|
$
|
221,332
|
|
|
Exercisable at September 30, 2016
|
20,042,258
|
|
|
$
|
4.19
|
|
|
4.02 years
|
|
$
|
172,458
|
|
|
|
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
Awards outstanding at December 31, 2015
|
1,002,188
|
|
|
$
|
5.16
|
|
|
|
|
|
||
|
Awarded
|
3,038,386
|
|
|
$
|
7.38
|
|
|
|
|
|
||
|
Vested and released
|
(1,390,654
|
)
|
|
$
|
5.55
|
|
|
|
|
|
||
|
Forfeited
|
(30,309
|
)
|
|
$
|
4.77
|
|
|
|
|
|
||
|
Awards outstanding at September 30, 2016
|
2,619,611
|
|
|
$
|
8.21
|
|
|
1.97 years
|
|
$
|
33,505
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Numerator:
|
|
|
|
|
|
|
|
||||||||
|
Net loss
|
$
|
(11,284
|
)
|
|
$
|
(45,542
|
)
|
|
$
|
(105,345
|
)
|
|
$
|
(120,176
|
)
|
|
Denominator:
|
|
|
|
|
|
|
|
||||||||
|
Shares used in computing basic and diluted net loss per share
|
256,319
|
|
|
217,587
|
|
|
238,024
|
|
|
203,153
|
|
||||
|
Net loss per share, basic and diluted
|
$
|
(0.04
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.59
|
)
|
|
|
September 30
|
||||
|
|
2016
|
|
2015
|
||
|
Convertible Senior Subordinated Notes due 2019
|
413
|
|
|
54,118
|
|
|
Secured Convertible Notes due 2018
|
33,890
|
|
|
33,890
|
|
|
Outstanding stock options, unvested RSUs and ESPP contributions
|
30,474
|
|
|
31,331
|
|
|
Warrants
|
1,000
|
|
|
1,000
|
|
|
Total potentially dilutive shares
|
65,777
|
|
|
120,339
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
|
Percentage of revenues earned in the United States
|
98
|
%
|
|
96
|
%
|
|
98
|
%
|
|
90
|
%
|
|
Percentage of revenues earned in Europe
|
2
|
%
|
|
4
|
%
|
|
2
|
%
|
|
10
|
%
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||
|
Product sales:
|
|
|
|
|
|
|
|
||||
|
Diplomat Specialty Pharmacy
|
31
|
%
|
|
66
|
%
|
|
41
|
%
|
|
79
|
%
|
|
Sobi
|
2
|
%
|
|
4
|
%
|
|
2
|
%
|
|
10
|
%
|
|
Collaboration agreements:
|
|
|
|
|
|
|
|
||||
|
Merck
|
—
|
%
|
|
30
|
%
|
|
4
|
%
|
|
11
|
%
|
|
Daiichi Sankyo
|
24
|
%
|
|
—
|
%
|
|
13
|
%
|
|
—
|
%
|
|
•
|
COTEZO, a phase 3 pivotal trial evaluating the combination of cobimetinib and atezolizumab, an anti-PD-L1 antibody, or atezolizumab alone versus regorafenib, in unresectable locally advanced or metastatic colorectal cancer, or CRC. COTEZO is expected to enroll 360 patients who have received at least two prior chemotherapies in the metastatic disease setting, and the primary endpoint of the trial is OS. The decision to start COTEZO was informed by results from the ongoing phase 1b trial of the combination in advanced solid tumors;
|
|
•
|
The combination of cobimetinib and vemuarfenib in additional melanoma patient populations and settings;
|
|
•
|
A phase 2 trial of cobimetinib in combination with paclitaxel in triple negative breast cancer;
|
|
•
|
Phase 1 studies of cobimetinib in combination with atezolizumab in melanoma and non-small cell lung cancer, or NSCLC, in combination with vemurafenib and atezolizumab in melanoma, and in combination with venetoclax in relapsed or refractory acute myeloid leukemia; and
|
|
•
|
A phase 1b study evaluating the safety, tolerability and pharmacokinetics of cobimetinib in combination with atezolizumab and bevacizumab in patients with metastatic colorectal cancer.
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Stated coupon interest
|
$
|
2,031
|
|
|
$
|
1,891
|
|
|
$
|
5,939
|
|
|
$
|
4,866
|
|
|
Amortization of debt discount, debt issuance costs and accrual of interest paid in kind
|
2,152
|
|
|
1,959
|
|
|
6,266
|
|
|
7,279
|
|
||||
|
Total interest expense
|
$
|
4,183
|
|
|
$
|
3,850
|
|
|
$
|
12,205
|
|
|
$
|
12,145
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Gross product revenues
|
$
|
46,720
|
|
|
$
|
7,230
|
|
|
$
|
92,383
|
|
|
$
|
25,794
|
|
|
Discounts and allowances
|
(3,978
|
)
|
|
(376
|
)
|
|
(8,924
|
)
|
|
(1,560
|
)
|
||||
|
Net product revenues
|
42,742
|
|
|
6,854
|
|
|
83,459
|
|
|
24,234
|
|
||||
|
Royalty and license revenues
(1)
|
4,452
|
|
|
—
|
|
|
10,414
|
|
|
—
|
|
||||
|
Contract revenues
(2)
|
15,000
|
|
|
3,000
|
|
|
20,000
|
|
|
3,000
|
|
||||
|
Total revenues
|
$
|
62,194
|
|
|
$
|
9,854
|
|
|
$
|
113,873
|
|
|
$
|
27,234
|
|
|
Dollar change
|
$
|
52,340
|
|
|
|
|
$
|
86,639
|
|
|
|
|
|||
|
Percentage change
|
531
|
%
|
|
|
|
318
|
%
|
|
|
|
|||||
|
(1)
|
Includes royalties and amortization of upfront payments.
|
|
(2)
|
Includes contingent and milestone payments.
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
CABOMETYX
|
$
|
31,238
|
|
|
$
|
—
|
|
|
$
|
48,812
|
|
|
$
|
—
|
|
|
COMETRIQ
|
11,504
|
|
|
6,854
|
|
|
34,647
|
|
|
24,234
|
|
||||
|
Net product revenues
|
$
|
42,742
|
|
|
$
|
6,854
|
|
|
$
|
83,459
|
|
|
$
|
24,234
|
|
|
Dollar change
|
$
|
35,888
|
|
|
|
|
$
|
59,225
|
|
|
|
||||
|
Percentage change
|
524
|
%
|
|
|
|
244
|
%
|
|
|
||||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Diplomat Specialty Pharmacy
|
$
|
19,392
|
|
|
$
|
6,457
|
|
|
$
|
46,770
|
|
|
$
|
21,567
|
|
|
Daiichi Sankyo
|
15,000
|
|
|
—
|
|
|
15,000
|
|
|
—
|
|
||||
|
Merck
|
—
|
|
|
3,000
|
|
|
5,000
|
|
|
3,000
|
|
||||
|
Swedish Orphan Biovitrum
|
1,350
|
|
|
397
|
|
|
2,453
|
|
|
2,667
|
|
||||
|
Others, individually less than 10% of total revenues for all periods presented
|
26,452
|
|
|
—
|
|
|
44,650
|
|
|
—
|
|
||||
|
Total revenues
|
$
|
62,194
|
|
|
$
|
9,854
|
|
|
$
|
113,873
|
|
|
$
|
27,234
|
|
|
Dollar change
|
$
|
52,340
|
|
|
|
|
|
$
|
86,639
|
|
|
|
|||
|
Percentage change
|
531
|
%
|
|
|
|
318
|
%
|
|
|
||||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Cost of goods sold
|
$
|
2,455
|
|
|
$
|
1,420
|
|
|
$
|
4,700
|
|
|
$
|
2,872
|
|
|
Gross margin
|
94
|
%
|
|
79
|
%
|
|
94
|
%
|
|
88
|
%
|
||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Research and development expenses
|
$
|
20,256
|
|
|
$
|
26,091
|
|
|
$
|
72,166
|
|
|
$
|
72,879
|
|
|
Dollar change
|
$
|
(5,835
|
)
|
|
|
|
$
|
(713
|
)
|
|
|
||||
|
Percentage change
|
(22
|
)%
|
|
|
|
(1
|
)%
|
|
|
||||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Selling, general and administrative expenses
|
$
|
32,463
|
|
|
$
|
17,842
|
|
|
$
|
103,143
|
|
|
$
|
40,162
|
|
|
Dollar change
|
$
|
14,621
|
|
|
|
|
$
|
62,981
|
|
|
|
||||
|
Percentage change
|
82
|
%
|
|
|
|
157
|
%
|
|
|
||||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Interest income and other, net
|
$
|
3,059
|
|
|
$
|
276
|
|
|
$
|
4,010
|
|
|
$
|
146
|
|
|
Interest expense
|
(7,834
|
)
|
|
(10,037
|
)
|
|
(28,575
|
)
|
|
(30,501
|
)
|
||||
|
Loss on extinguishment of debt
|
(13,773
|
)
|
|
—
|
|
|
(13,773
|
)
|
|
—
|
|
||||
|
Total other income (expense), net
|
$
|
(18,548
|
)
|
|
$
|
(9,761
|
)
|
|
$
|
(38,338
|
)
|
|
$
|
(30,355
|
)
|
|
Dollar change
|
$
|
(8,787
|
)
|
|
|
|
$
|
(7,983
|
)
|
|
|
||||
|
Percentage change
|
90
|
%
|
|
|
|
26
|
%
|
|
|
||||||
|
|
Nine Months Ended September 30,
|
||||||
|
|
2016
|
|
2015
|
||||
|
Net loss
|
$
|
(105,345
|
)
|
|
$
|
(120,176
|
)
|
|
Net cash provided by (used in) operating activities
|
122,582
|
|
|
(106,152
|
)
|
||
|
Net cash (used in) provided by investing activities
|
(155,638
|
)
|
|
26,068
|
|
||
|
Net cash provided by financing activities
|
2,641
|
|
|
145,331
|
|
||
|
Net (decrease) increase in cash and cash equivalents
|
(30,415
|
)
|
|
65,247
|
|
||
|
Cash and cash equivalents at beginning of period
|
141,634
|
|
|
80,395
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
111,219
|
|
|
$
|
145,642
|
|
|
•
|
the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
|
|
•
|
costs associated with maintaining our expanded sales, marketing, medical affairs and distribution capabilities for CABOMETYX in the approved advanced RCC indications and COMETRIQ in the approved MTC indications;
|
|
•
|
the achievement of stated regulatory and commercial milestones under our collaboration with Ipsen;
|
|
•
|
the commercial success of COTELLIC and the calculation of our share of related profits and losses for the commercialization of COTELLIC in the U.S. and royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech;
|
|
•
|
the outcome of our arbitration against Genentech in which we have asserted claims related to Genentech’s clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations arising from COTELLIC’s commercialization in the United States and Genentech’s counterclaim for breach of contract, seeking monetary damages and interest related to the cost allocations under the collaboration agreement;
|
|
•
|
the potential regulatory approval of cabozantinib as a treatment for previously untreated advanced RCC in the United States, and in other indications both in the United States and abroad;
|
|
•
|
future clinical trial results, notably the results from CELESTIAL, our phase 3 pivotal trial in patients with advanced HCC;
|
|
•
|
our future investments in the expansion of our pipeline through drug discovery and corporate development activities;
|
|
•
|
repayment of the Deerfield Notes (see “Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Certain Factors Important to Understanding Our Financial Condition and Results of Operations - Deerfield Notes” for a description of these notes) which mature on July 1, 2018, subject to a requirement to make a mandatory prepayment in each of 2017 and 2018 equal to 15% of certain revenues from collaborative arrangements (other than intercompany arrangements) received during the prior fiscal year, subject to a maximum annual prepayment amount of $27.5 million;
|
|
•
|
our ability to repay the Deerfield Notes with our common stock, which we are only able to do under specified conditions;
|
|
•
|
repayment of our term loan from Silicon Valley Bank, which had an outstanding balance at
September 30, 2016
, of
$80.0 million
and is due in May 2017;
|
|
•
|
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 cost of clinical drug supply for our clinical trials;
|
|
•
|
trends and developments in the pricing of oncologic therapeutics in the United States and abroad, especially in the European Union;
|
|
•
|
scientific developments in the market for oncologic therapeutics and the timing of regulatory approvals for competing oncologic therapies; and
|
|
•
|
the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights.
|
|
•
|
the effectiveness, or perceived effectiveness, of cabozantinib in comparison to competing products;
|
|
•
|
the existence of any significant side effects of cabozantinib, as well as their severity in comparison to those of any competing products;
|
|
•
|
cabozantinib’s potential advantages or disadvantages in relation to alternative treatments;
|
|
•
|
the timing of market entry relative to competitive treatments;
|
|
•
|
indications for which cabozantinib is approved;
|
|
•
|
the ability to offer cabozantinib for sale at competitive prices;
|
|
•
|
relative convenience and ease of administration;
|
|
•
|
the strength of sales, marketing, medical affairs and distribution support; and
|
|
•
|
sufficient third-party coverage and by government and commercial and other payers.
|
|
•
|
the federal Anti-Kickback Law, which constrains our business activities, including our marketing practices, educational programs, pricing policies, and relationships with healthcare providers or other entities, by prohibiting, among other things, persons and entities 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,
|
|
•
|
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 payers 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;
|
|
•
|
the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information;
|
|
•
|
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 payer, 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 compliance 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 cabozantinib, 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.
|
|
•
|
fund our operations and clinical trials;
|
|
•
|
continue our research and development efforts;
|
|
•
|
expand our sales, marketing and distribution capabilities;
|
|
•
|
commercialize cabozantinib or any other future product candidates, if any such candidates receive regulatory approval for commercial sale; and
|
|
•
|
fund the portion of U.S. sales and marketing costs for cobimetinib that we are obligated to fund under our collaboration with Genentech (a member of the Roche Group), or any similar costs we are obligated to fund under collaborations we may enter into in the future.
|
|
•
|
the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
|
|
•
|
costs associated with maintaining our expanded sales, marketing, medical affairs and distribution capabilities for CABOMETYX in advanced RCC and COMETRIQ in the approved MTC indications;
|
|
•
|
the achievement of stated regulatory and commercial milestones under our collaboration with Ipsen;
|
|
•
|
the commercial success of COTELLIC and the calculation of our share of related profits and losses for the commercialization of COTELLIC in the U.S. and royalties from COTELLIC sales outside the U.S. under our collaboration with Genentech;
|
|
•
|
the outcome of our arbitration against Genentech in which we have asserted claims related to Genentech’s clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations arising from COTELLIC’s commercialization in the United States and Genentech’s counterclaim for breach of contract, seeking monetary damages and interest related to the cost allocations under the collaboration agreement;
|
|
•
|
the potential regulatory approval of cabozantinib as a treatment for previously untreated advanced RCC and in other indications, both in the United States and abroad;
|
|
•
|
future clinical trial results, notably the results from CELESTIAL, our phase 3 pivotal trial in patients with advanced HCC;
|
|
•
|
our future investments in the expansion of our pipeline through drug discovery and corporate development activities;
|
|
•
|
repayment of the Deerfield Notes (see “Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Certain Factors Important to Understanding Our Financial Condition and Results of Operations - Deerfield Notes” for a description of these notes) which mature on July 1, 2018, subject to a requirement to make a mandatory prepayment in each of 2017 and 2018 equal to 15% of certain revenues from collaborative arrangements (other than intercompany arrangements) received during the prior fiscal year, subject to a maximum annual prepayment amount of $27.5 million;
|
|
•
|
our ability to repay the Deerfield Notes with our common stock, which we are only able to do under specified conditions;
|
|
•
|
repayment of our term loan from Silicon Valley Bank, which had an outstanding balance at
September 30, 2016
, of
$80.0 million
and is due in May 2017;
|
|
•
|
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 cost of clinical drug supply for our clinical trials;
|
|
•
|
trends and developments in the pricing of oncologic therapeutics in the United States and abroad, especially in the European Union;
|
|
•
|
scientific developments in the market for oncologic therapeutics and the timing of regulatory approvals for competing oncologic therapies; and
|
|
•
|
the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights.
|
|
•
|
making it more difficult for us to meet our payment and other obligations under the Deerfield Notes and 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 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 clinical trials, research and development, capital expenditures, working capital and other general corporate purposes;
|
|
•
|
limiting our flexibility in planning for, or reacting to, changes in our business;
|
|
•
|
dilution experienced by our existing stockholders as a result of the conversion of 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.
|
|
•
|
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;
|
|
•
|
we are not able to control the U.S. commercial resourcing decisions made and resulting costs incurred by Genentech for cobimetinib, which reasonable costs we are obligated to share, in part, under our collaboration agreement with Genentech;
|
|
•
|
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 diminish or delay receipt of the economic benefits we are entitled to receive under the collaboration, or that result in costly litigation or arbitration that diverts management’s attention and resources, such as the demand for arbitration we filed on June 3, 2016 asserting claims against Genentech for breaches of the collaboration agreement connected with its clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations arising from COTELLIC’s commercialization in the United States;
|
|
•
|
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;
|
|
•
|
collaborators may not comply with applicable healthcare regulatory laws;
|
|
•
|
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 or allowed to expire, which would delay, and may increase the cost of development of our drug candidates.
|
|
•
|
the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
|
|
•
|
customer ordering patterns for CABOMETYX and COMETRIQ, which may vary significantly from period to period;
|
|
•
|
the overall level of demand for CABOMETYX and COMETRIQ, including the impact of any competitive products and the duration of therapy for patients receiving CABOMETYX or COMETRIQ;
|
|
•
|
costs associated with maintaining our expanded sales, marketing, medical affairs and distribution capabilities for CABOMETYX and COMETRIQ;
|
|
•
|
our ability to obtain regulatory approval for cabozantinib as a treatment of first-line advanced RCC;
|
|
•
|
the achievement of stated regulatory and commercial milestones, under our collaboration with Ipsen;
|
|
•
|
the outcome of our arbitration against Genentech in which we have asserted claims related to Genentech’s clinical development, pricing and commercialization of COTELLIC, and cost and revenue allocations arising from COTELLIC’s commercialization in the United States and Genentech’s counterclaim for breach of contract, seeking monetary damages and interest related to the cost allocations under the collaboration agreement;
|
|
•
|
the progress and scope of other development and commercialization activities for cabozantinib and our other compounds;
|
|
•
|
future clinical trial results, notably the results from CELESTIAL, our phase 3 pivotal trial in patients with advanced HCC;
|
|
•
|
our future investments in the expansion of our pipeline through drug discovery and corporate development activities;
|
|
•
|
the inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices;
|
|
•
|
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;
|
|
•
|
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 candidates out-licensed to them;
|
|
•
|
the termination or non-renewal of existing collaborations or third party vendor relationships;
|
|
•
|
regulatory actions with respect to our product candidates and any approved products or our competitors’ products;
|
|
•
|
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
|
|
•
|
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;
|
|
•
|
additions and departures of key personnel;
|
|
•
|
general and industry-specific economic conditions that may affect our or our collaborators’ research and development expenditures; and
|
|
•
|
other factors described in this “Risk Factors” section.
|
|
•
|
adverse results or delays in our or our collaborators’ clinical trials;
|
|
•
|
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;
|
|
•
|
the commercial success of both CABOMETYX and COMETRIQ and the revenues we generate from those approved products;
|
|
•
|
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 cabozantinib or any of our other programs or compounds;
|
|
•
|
actions taken by regulatory agencies with respect to cabozantinib or our clinical trials for cabozantinib;
|
|
•
|
the announcement of new products by our competitors;
|
|
•
|
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, including the outcome of our arbitration with Genentech regarding COTELLIC;
|
|
•
|
litigation, including intellectual property infringement and product liability lawsuits, involving us;
|
|
•
|
failure to achieve operating results projected by securities analysts;
|
|
•
|
changes in earnings estimates or recommendations by securities analysts;
|
|
•
|
financing transactions;
|
|
•
|
developments in the biotechnology, biopharmaceutical 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;
|
|
•
|
FDA or international regulatory actions;
|
|
•
|
third-party coverage and reimbursement policies;
|
|
•
|
disposition of any of our 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;
|
|
•
|
limitations on the removal of directors; and
|
|
•
|
advance notice requirements for director nominations and stockholder proposals.
|
|
|
|
|
EXELIXIS, INC.
|
|
|
|
|
|
|
|
|
|
November 3, 2016
|
|
/s/ C
HRISTOPHER
J. S
ENNER
|
|
|
|
Date
|
|
Christopher J. Senner
|
|
|
|
|
|
Executive Vice President and Chief Financial Officer
|
|
|
|
|
|
(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
|
|
Certificate of Ownership and Merger Merging X-Ceptor Therapeutics, Inc. with and into Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
3.1
|
|
10/15/2014
|
|
|
|
3.5
|
|
Certificate of Change of Registered Agent and/or Registered Office of Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
3.2
|
|
10/15/2014
|
|
|
|
3.6
|
|
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
|
|
4/7/2000
|
|
|
|
4.2
|
|
Amended and Restated Secured Convertible Note dated July 1, 2015 in favor of Deerfield Partners, L.P.
|
|
10-Q
|
|
000-30235
|
|
4.2
|
|
8/11/2015
|
|
|
|
4.3
|
|
Amended and Restated Secured Convertible Note dated July 1, 2015 in favor of Deerfield International Master Fund, L.P.
|
|
10-Q
|
|
000-30235
|
|
4.3
|
|
8/11/2015
|
|
|
|
4.4
|
|
Registration Rights Agreement dated January 22, 2014 by and among Exelixis, Inc., Deerfield Partners, L.P. and Deerfield International Master Fund, L.P.
|
|
8-K
|
|
000-30235
|
|
4.2
|
|
1/22/2014
|
|
|
|
4.5
|
|
Form of Warrant to Purchase Common Stock of Exelixis, Inc. issued to OTA LLC
|
|
10-Q
|
|
000-30235
|
|
4.5
|
|
11/10/2015
|
|
|
|
4.6
|
|
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
|
|
|
|
4.7
|
|
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
|
|
|
|
4.8
|
|
Form of 4.25% Convertible Senior Subordinated Note due 2019
|
|
8-K
|
|
000-30235
|
|
4.2
(Exhibit A)
|
|
8/14/2012
|
|
|
|
10.1
|
|
Form of Exchange Agreement Related to 4.25% Convertible Senior Subordinated Notes
|
|
8-K
|
|
000-30235
|
|
99.1
|
|
8/9/2016
|
|
|
|
10.2
|
|
Form of Exchange Agreement Related to 4.25% Convertible Senior Subordinated Notes
|
|
8-K
|
|
000-30235
|
|
99.1
|
|
8/22/2016
|
|
|
|
12.1
|
|
Statement Re Computation of Earnings to Fixed Charges
|
|
|
|
|
|
|
|
|
|
X
|
|
31.1
|
|
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
|
|
|||||
|
31.2
|
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a).
|
|
|
|
|
|
|
|
|
|
X
|
|
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
|
|
‡
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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.
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* 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 |
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| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
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No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
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