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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
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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 No.)
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(650) 837-7000
(Registrant’s Telephone Number, Including Area Code)
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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 1A.
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Item 2.
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Item 6.
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EXHIBITS
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Exhibit 31.1
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Exhibit 31.2
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Exhibit 32.1
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ITEM 1.
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FINANCIAL STATEMENTS
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|
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September 30,
2012 |
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December 31,
2011 (1) |
||||
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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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308,805
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|
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$
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74,257
|
|
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Marketable securities
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163,542
|
|
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120,005
|
|
||
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Short-term restricted cash and investments
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12,242
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|
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—
|
|
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Other receivables
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2,708
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30,190
|
|
||
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Prepaid expenses and other current assets
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6,098
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|
|
4,372
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|
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Total current assets
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493,395
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|
|
228,824
|
|
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Restricted cash and investments
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27,946
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4,199
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Long-term investments
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162,173
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85,260
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Property and equipment, net
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6,292
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8,506
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Goodwill
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63,684
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63,684
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Other assets
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9,123
|
|
|
2,789
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|
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Total assets
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$
|
762,613
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$
|
393,262
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|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
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||||
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Current liabilities:
|
|
|
|
||||
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Accounts payable
|
$
|
3,246
|
|
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$
|
1,957
|
|
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Accrued clinical trial liabilities
|
23,701
|
|
|
21,729
|
|
||
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Accrued compensation and benefits
|
8,255
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|
|
8,943
|
|
||
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Other accrued liabilities
|
8,882
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|
|
8,423
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|
||
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Current portion of notes payable and bank obligations
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3,164
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|
|
4,870
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|
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Current portion of convertible loans
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10,000
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|
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—
|
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Current portion of restructuring
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4,033
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4,483
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Deferred revenue
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24,134
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41,920
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Total current liabilities
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85,415
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|
92,325
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Long-term portion of notes payable and bank obligations
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82,885
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85,260
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Long-term portion of convertible loans
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239,244
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91,385
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Long-term portion of restructuring
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6,456
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9,495
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Other long-term liabilities
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7,768
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7,844
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Deferred revenue
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—
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16,321
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Total liabilities
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$
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421,768
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$
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302,630
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Commitments
|
|
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||||
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Stockholders’ equity:
|
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||||
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Common stock, $0.001 par value; 4
00,000,000 and 200,000,000 shares authorized at September 30, 2012 and December 31, 2011, respectively; issued and outstanding:
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||||
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183,489,026 and 135,563,735 shares at September 30, 2012 and December 31, 2011, respectively:
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183
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135
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Additional paid-in-capital
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1,542,489
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1,196,992
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Accumulated other comprehensive income (loss)
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(18
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)
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(138
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)
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Accumulated deficit
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(1,201,809
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)
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(1,106,357
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)
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Total stockholders’ equity
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340,845
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90,632
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Total liabilities and stockholders’ equity
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$
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762,613
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$
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393,262
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(1)
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The condensed consolidated balance sheet at December 31, 2011 has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements.
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Three Months Ended
September 30, |
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Nine Months Ended
September 30, |
||||||||||||
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2012
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2011
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2012
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2011
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Revenues:
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Contract
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$
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9,301
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$
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5,024
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$
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16,934
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$
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25,761
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License
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4,012
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122,703
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22,702
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167,984
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||||
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Collaboration reimbursement
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—
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545
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—
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2,583
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||||
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Total revenues
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13,313
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128,272
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39,636
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196,328
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Operating expenses:
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Research and development
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30,680
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37,465
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96,386
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126,058
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||||
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General and administrative
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7,343
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8,171
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22,008
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26,119
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||||
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Restructuring charge
|
733
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2,937
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1,704
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|
6,190
|
|
||||
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Total operating expenses
|
38,756
|
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|
48,573
|
|
|
120,098
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|
|
158,367
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|
||||
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(Loss) income from operations
|
(25,443
|
)
|
|
79,699
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|
|
(80,462
|
)
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|
37,961
|
|
||||
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Other income (expense), net:
|
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||||||||
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Interest income and other, net
|
318
|
|
|
98
|
|
|
818
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|
|
1,479
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|
||||
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Interest expense
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(7,679
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)
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(4,142
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)
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(15,775
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)
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(12,249
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)
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||||
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Gain on sale of business
|
—
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2,210
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—
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2,210
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||||
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Total other income (expense), net
|
(7,361
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)
|
|
(1,834
|
)
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|
(14,957
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)
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|
(8,560
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)
|
||||
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(Loss) income before income taxes
|
(32,804
|
)
|
|
77,865
|
|
|
(95,419
|
)
|
|
29,401
|
|
||||
|
Income tax provision
|
(10
|
)
|
|
—
|
|
|
(33
|
)
|
|
—
|
|
||||
|
Net (loss) income
|
$
|
(32,814
|
)
|
|
$
|
77,865
|
|
|
$
|
(95,452
|
)
|
|
$
|
29,401
|
|
|
Net (loss) income per share, basic
|
$
|
(0.20
|
)
|
|
$
|
0.60
|
|
|
$
|
(0.63
|
)
|
|
$
|
0.24
|
|
|
Net (loss) income per share, diluted
|
$
|
(0.20
|
)
|
|
$
|
0.59
|
|
|
$
|
(0.63
|
)
|
|
$
|
0.23
|
|
|
Shares used in computing basic (loss) income per share amounts
|
166,354
|
|
|
129,145
|
|
|
152,316
|
|
|
123,426
|
|
||||
|
Shares used in computing diluted (loss) income per share amounts
|
166,354
|
|
|
131,344
|
|
|
152,316
|
|
|
129,430
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
Net (loss) income
|
$
|
(32,814
|
)
|
|
$
|
77,865
|
|
|
$
|
(95,452
|
)
|
|
$
|
29,401
|
|
|
Net unrealized (losses) gains on available-for-sale securities
|
(23
|
)
|
|
(236
|
)
|
|
120
|
|
|
(261
|
)
|
||||
|
Comprehensive (loss) income
|
$
|
(32,837
|
)
|
|
$
|
77,629
|
|
|
$
|
(95,332
|
)
|
|
$
|
29,140
|
|
|
|
Nine Months Ended September 30,
|
||||||
|
|
2012
|
|
2011
|
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net (loss) income
|
$
|
(95,452
|
)
|
|
$
|
29,401
|
|
|
Adjustments to reconcile net (loss) income to net cash used in operating activities:
|
|
|
|
||||
|
Depreciation and amortization
|
4,071
|
|
|
5,035
|
|
||
|
Stock-based compensation expense
|
6,222
|
|
|
9,409
|
|
||
|
Restructuring (credit) charge for property and equipment
|
(141
|
)
|
|
379
|
|
||
|
Gain on sale of business
|
—
|
|
|
(2,210
|
)
|
||
|
Accretion of debt discount
|
8,624
|
|
|
5,900
|
|
||
|
Other
|
3,450
|
|
|
3,637
|
|
||
|
Changes in assets and liabilities:
|
|
|
|
||||
|
Other receivables
|
27,082
|
|
|
1,242
|
|
||
|
Prepaid expenses and other current assets
|
(1,892
|
)
|
|
(1,522
|
)
|
||
|
Other assets
|
(1,983
|
)
|
|
701
|
|
||
|
Accounts payable and other accrued expenses
|
3,280
|
|
|
(2,225
|
)
|
||
|
Restructuring liability
|
(3,489
|
)
|
|
(3,886
|
)
|
||
|
Other long-term liabilities
|
(76
|
)
|
|
(758
|
)
|
||
|
Deferred revenue
|
(34,106
|
)
|
|
(175,162
|
)
|
||
|
Net cash used in operating activities
|
(84,410
|
)
|
|
(130,059
|
)
|
||
|
Cash flows from investing activities:
|
|
|
|
||||
|
Purchases of property and equipment
|
(1,528
|
)
|
|
(712
|
)
|
||
|
Proceeds from sales of property and equipment
|
877
|
|
|
—
|
|
||
|
Proceeds on sale of business
|
—
|
|
|
3,010
|
|
||
|
(Increase) decrease in restricted cash and investments
|
(35,989
|
)
|
|
2,200
|
|
||
|
Proceeds from maturities of marketable securities
|
236,323
|
|
|
117,244
|
|
||
|
Purchases of marketable securities
|
(359,524
|
)
|
|
(210,580
|
)
|
||
|
Net cash used in investing activities
|
(159,841
|
)
|
|
(88,838
|
)
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Proceeds from issuance of common stock, net
|
203,479
|
|
|
179,377
|
|
||
|
Proceeds from convertible notes, net
|
277,673
|
|
|
—
|
|
||
|
Proceeds from exercise of stock options and warrants
|
901
|
|
|
11,705
|
|
||
|
Proceeds from employee stock purchase plan
|
828
|
|
|
987
|
|
||
|
Proceeds from note payable and bank obligations
|
—
|
|
|
2,589
|
|
||
|
Principal payments on notes payable and bank obligations
|
(4,082
|
)
|
|
(6,990
|
)
|
||
|
Net cash provided by financing activities
|
478,799
|
|
|
187,668
|
|
||
|
Net increase (decrease) in cash and cash equivalents
|
234,548
|
|
|
(31,229
|
)
|
||
|
Cash and cash equivalents, at beginning of period
|
74,257
|
|
|
97,440
|
|
||
|
Cash and cash equivalents, at end of period
|
$
|
308,805
|
|
|
$
|
66,211
|
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Money market funds
|
$
|
139,645
|
|
|
$
|
7
|
|
|
$
|
(4
|
)
|
|
$
|
139,648
|
|
|
Commercial paper
|
258,942
|
|
|
17
|
|
|
—
|
|
|
258,959
|
|
||||
|
Corporate bonds
|
162,787
|
|
|
44
|
|
|
(94
|
)
|
|
162,737
|
|
||||
|
U.S. Government sponsored enterprises
|
81,787
|
|
|
16
|
|
|
(2
|
)
|
|
81,801
|
|
||||
|
Municipal bonds
|
31,566
|
|
|
—
|
|
|
(3
|
)
|
|
31,563
|
|
||||
|
Total
|
$
|
674,727
|
|
|
$
|
84
|
|
|
$
|
(103
|
)
|
|
$
|
674,708
|
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
As reported:
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents
|
$
|
308,804
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
308,805
|
|
|
Marketable securities
|
163,543
|
|
|
64
|
|
|
(66
|
)
|
|
163,541
|
|
||||
|
Restricted cash and investments
|
40,185
|
|
|
7
|
|
|
(4
|
)
|
|
40,188
|
|
||||
|
Long-term investments
|
162,195
|
|
|
12
|
|
|
(33
|
)
|
|
162,174
|
|
||||
|
Total
|
$
|
674,727
|
|
|
$
|
84
|
|
|
$
|
(103
|
)
|
|
$
|
674,708
|
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Money market funds
|
$
|
81,986
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
81,986
|
|
|
Commercial paper
|
29,079
|
|
|
2
|
|
|
(1
|
)
|
|
29,080
|
|
||||
|
Corporate bonds
|
116,068
|
|
|
22
|
|
|
(169
|
)
|
|
115,921
|
|
||||
|
U.S. Government sponsored enterprises
|
37,237
|
|
|
12
|
|
|
—
|
|
|
37,249
|
|
||||
|
Municipal bonds
|
19,488
|
|
|
—
|
|
|
(3
|
)
|
|
19,485
|
|
||||
|
Total
|
$
|
283,858
|
|
|
$
|
36
|
|
|
$
|
(173
|
)
|
|
$
|
283,721
|
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
As reported:
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents
|
$
|
74,256
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
74,257
|
|
|
Marketable securities
|
120,143
|
|
|
35
|
|
|
(173
|
)
|
|
120,005
|
|
||||
|
Restricted cash and investments
|
4,199
|
|
|
—
|
|
|
—
|
|
|
4,199
|
|
||||
|
Long-term investments
|
85,260
|
|
|
—
|
|
|
—
|
|
|
85,260
|
|
||||
|
Total
|
$
|
283,858
|
|
|
$
|
36
|
|
|
$
|
(173
|
)
|
|
$
|
283,721
|
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Mature in less than one year
|
$
|
555,899
|
|
|
$
|
65
|
|
|
$
|
(67
|
)
|
|
$
|
555,897
|
|
|
Mature in one to two years
|
118,828
|
|
|
19
|
|
|
(36
|
)
|
|
118,811
|
|
||||
|
Total
|
$
|
674,727
|
|
|
$
|
84
|
|
|
$
|
(103
|
)
|
|
$
|
674,708
|
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Mature in less than one year
|
$
|
259,209
|
|
|
$
|
24
|
|
|
$
|
(151
|
)
|
|
$
|
259,082
|
|
|
Mature in one to two years
|
24,649
|
|
|
12
|
|
|
(22
|
)
|
|
24,639
|
|
||||
|
Total
|
$
|
283,858
|
|
|
$
|
36
|
|
|
$
|
(173
|
)
|
|
$
|
283,721
|
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
Money market funds
|
$
|
139,648
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
139,648
|
|
|
Commercial paper
|
—
|
|
|
258,959
|
|
|
—
|
|
|
258,959
|
|
||||
|
Corporate bonds
|
—
|
|
|
162,737
|
|
|
—
|
|
|
162,737
|
|
||||
|
U.S. Government sponsored agencies
|
—
|
|
|
81,801
|
|
|
—
|
|
|
81,801
|
|
||||
|
Municipal bonds
|
—
|
|
|
31,563
|
|
|
—
|
|
|
31,563
|
|
||||
|
Total
|
$
|
139,648
|
|
|
$
|
535,060
|
|
|
$
|
—
|
|
|
$
|
674,708
|
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
Money market funds
|
$
|
81,986
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
81,986
|
|
|
Commercial paper
|
—
|
|
|
29,080
|
|
|
—
|
|
|
29,080
|
|
||||
|
Corporate bonds
|
—
|
|
|
115,921
|
|
|
—
|
|
|
115,921
|
|
||||
|
U.S. Government sponsored agencies
|
—
|
|
|
37,249
|
|
|
—
|
|
|
37,249
|
|
||||
|
Municipal bonds
|
—
|
|
|
19,485
|
|
|
—
|
|
|
19,485
|
|
||||
|
Total
|
$
|
81,986
|
|
|
$
|
201,735
|
|
|
$
|
—
|
|
|
$
|
283,721
|
|
|
|
September 30,
2012 |
|
December 31,
2011 |
||||
|
Equipment lines of credit
|
$
|
6,006
|
|
|
$
|
10,066
|
|
|
Silicon Valley Bank loan
|
77,981
|
|
|
77,835
|
|
||
|
Convertible senior subordinated notes due 2019 (face value $287,500)
|
305,900
|
|
|
—
|
|
||
|
Total
|
$
|
389,887
|
|
|
$
|
87,901
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||
|
Numerator:
|
|
|
|
|
|
|
|
||||
|
Net (loss) income
|
$(32,814)
|
|
$77,865
|
|
$(95,452)
|
|
$29,401
|
||||
|
Denominator:
|
|
|
|
|
|
|
|
||||
|
Shares used in computing basic (loss) income per share amounts
|
166,354
|
|
|
129,145
|
|
|
152,316
|
|
|
123,426
|
|
|
Add effect of dilutive securities:
|
|
|
|
|
|
|
|
||||
|
Shares issuable upon conversion of our GlaxoSmithKline loan
|
—
|
|
|
449
|
|
|
—
|
|
|
1,568
|
|
|
Shares issuable upon the exercise of outstanding stock options
|
—
|
|
|
1,444
|
|
|
—
|
|
|
3,471
|
|
|
Shares issuable pursuant to the issuance of vested RSUs
|
—
|
|
|
144
|
|
|
—
|
|
|
558
|
|
|
Shares issuable pursuant to the exercise of warrants
|
—
|
|
|
48
|
|
|
—
|
|
|
281
|
|
|
Shares issuable upon the purchase of ESPP
|
—
|
|
|
114
|
|
|
—
|
|
|
126
|
|
|
Shares used in computing diluted net (loss) income per common share
|
—
|
|
|
2,199
|
|
|
—
|
|
|
6,004
|
|
|
Shares used in computing diluted (loss) income per share amounts
|
166,354
|
|
|
131,344
|
|
|
152,316
|
|
|
129,430
|
|
|
Net (loss) income per share, basic
|
$(0.20)
|
|
$0.60
|
|
$(0.63)
|
|
$0.24
|
||||
|
Net (loss) income per share, diluted
|
$(0.20)
|
|
$0.59
|
|
$(0.63)
|
|
$0.23
|
||||
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
Research and development expense
|
$
|
970
|
|
|
$
|
1,378
|
|
|
$
|
3,202
|
|
|
$
|
4,557
|
|
|
General and administrative expense
|
923
|
|
|
1,401
|
|
|
2,970
|
|
|
4,102
|
|
||||
|
Restructuring-related stock-based compensation expense
|
—
|
|
|
176
|
|
|
—
|
|
|
625
|
|
||||
|
Total employee stock-based compensation expense
|
$
|
1,893
|
|
|
$
|
2,955
|
|
|
$
|
6,172
|
|
|
$
|
9,284
|
|
|
|
Stock Options Three Months Ended
September 30, |
|
Employee Stock Purchase Plan Three Months Ended
September 30, |
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
Weighted average grant date fair value
|
$
|
3.31
|
|
|
$
|
3.28
|
|
|
$
|
1.63
|
|
|
$
|
4.24
|
|
|
Risk-free interest rate
|
0.81
|
%
|
|
0.97
|
%
|
|
0.15
|
%
|
|
0.10
|
%
|
||||
|
Dividend yield
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
||||
|
Volatility
|
69
|
%
|
|
70
|
%
|
|
68
|
%
|
|
70
|
%
|
||||
|
Expected life
|
5.6 years
|
|
5.4 years
|
|
0.5 years
|
|
0.5 years
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
|
|
Stock Options Nine Months Ended
September 30, |
|
Employee Stock Purchase Plan Nine Months Ended
September 30, |
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
Weighted average grant date fair value
|
$
|
3.27
|
|
|
$
|
3.52
|
|
|
$
|
2.13
|
|
|
$
|
3.05
|
|
|
Risk-free interest rate
|
0.82
|
%
|
|
1.05
|
%
|
|
0.10
|
%
|
|
0.13
|
%
|
||||
|
Dividend yield
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
||||
|
Volatility
|
69
|
%
|
|
70
|
%
|
|
68
|
%
|
|
68
|
%
|
||||
|
Expected life
|
5.7 years
|
|
5.5 years
|
|
0.5 years
|
|
0.5 years
|
||||||||
|
|
Shares
|
|
Weighted Average
Exercise Price
|
|
Weighted Average
Remaining
Contractual Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
Options outstanding at December 31, 2011
|
17,436,378
|
|
|
$
|
7.16
|
|
|
|
|
|
||
|
Granted
|
3,300,546
|
|
|
5.49
|
|
|
|
|
|
|||
|
Exercised
|
(175,708
|
)
|
|
5.12
|
|
|
|
|
|
|||
|
Cancelled
|
(1,399,526
|
)
|
|
7.92
|
|
|
|
|
|
|||
|
Options outstanding at September 30, 2012
|
19,161,690
|
|
|
$
|
6.84
|
|
|
4.64 years
|
|
$
|
287,800
|
|
|
Exercisable at September 30, 2012
|
13,559,920
|
|
|
$
|
7.32
|
|
|
3.80 years
|
|
$
|
239,408
|
|
|
|
Shares
|
|
Weighted Average
Grant Date Fair Value
|
|
Weighted Average
Remaining
Contractual Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
RSUs outstanding at December 31, 2011
|
1,391,691
|
|
|
$
|
6.92
|
|
|
|
|
|
||
|
Awarded
|
711,575
|
|
|
5.53
|
|
|
|
|
|
|||
|
Released
|
(459,416
|
)
|
|
7.33
|
|
|
|
|
|
|||
|
Forfeited
|
(201,987
|
)
|
|
6.74
|
|
|
|
|
|
|||
|
RSUs outstanding at September 30, 2012
|
1,441,863
|
|
|
$
|
6.13
|
|
|
1.84 years
|
|
$
|
6,956,995
|
|
|
|
Employee Severance
And Other Benefits
|
|
Facility
Charges
|
|
Asset
Impairment, net of sales
|
|
Legal and
Other Fees
|
|
Total
|
||||||||||
|
Ending accrual balance as of December 31, 2011
|
$
|
6
|
|
|
$
|
13,921
|
|
|
$
|
—
|
|
|
$
|
51
|
|
|
$
|
13,978
|
|
|
Restructuring charge (credit)
|
1,046
|
|
|
866
|
|
|
(180
|
)
|
|
(28
|
)
|
|
1,704
|
|
|||||
|
Cash payments
|
(909
|
)
|
|
(4,451
|
)
|
|
—
|
|
|
(3
|
)
|
|
(5,363
|
)
|
|||||
|
Adjustments or non-cash credits
|
(10
|
)
|
|
—
|
|
|
(697
|
)
|
|
—
|
|
|
(707
|
)
|
|||||
|
Proceeds from sale of assets
|
—
|
|
|
—
|
|
|
877
|
|
|
—
|
|
|
877
|
|
|||||
|
Ending accrual balance as of September 30, 2012
|
$
|
133
|
|
|
$
|
10,336
|
|
|
$
|
—
|
|
|
$
|
20
|
|
|
$
|
10,489
|
|
|
|
September 30, 2012
|
||
|
Net carrying amount of the liability component
|
$
|
151,024
|
|
|
Unamortized discount of the liability component
|
$
|
136,476
|
|
|
Face Value of the 2019 Notes
|
$
|
287,500
|
|
|
ITEM 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
•
|
Phase 2 clinical trials in disease settings where there is substantial unmet medical need and in which cabozantinib has previously demonstrated clinical activity, consisting of randomized phase 2 clinical trials in first line renal cell carcinoma, platinum-resistant or refractory ovarian cancer, ocular melanoma, second line non-small cell lung cancer, and second line/third line non-small cell lung cancer. We believe that data from these phase 2 clinical trials will help prioritize future phase 3 pivotal trials of cabozantinib.
|
|
•
|
Additional phase 2 clinical trials to explore cabozantinib's potential utility in other tumor types, consisting of trials in endometrial cancer, bladder cancer, sarcoma and second line differentiated thyroid cancer. Positive results in these indications could lead to further study in randomized phase 2 or phase 3 clinical trials.
|
|
•
|
Additional phase 1 clinical trials, consisting of a trial evaluating cabozantinib in combination with docetaxel in CRPC patients, a trial exploring the utility of combining cabozantinib with vemurafenib, a BRAF inhibitor, in patients with BRAF-mutated melanoma, and a trial to evaluate the safety and phamacokinetics of cabozantinib in pediatric patients.
|
|
•
|
the progress and scope of the development and commercialization activities with respect to cabozantinib;
|
|
•
|
whether we elect to redeem for cash, all or a portion of the 4.25% convertible senior subordinated notes due 2019, or the 2019 Notes, issued and sold by us on August 14, 2012, prior to their maturity date;
|
|
•
|
whether we elect to pay cash or to issue shares of our common stock in respect of any conversion of the 2019 Notes;
|
|
•
|
whether we elect to pay cash or to issue shares of our common stock in respect of any conversion of our principal, prepayments or payments of interest in connection with the secured convertible notes we issued to entities affiliated with Deerfield Management Company, L.P., or Deerfield, under our note purchase agreement;
|
|
•
|
whether we elect to prepay the amounts advanced under our loan from Silicon Valley Bank;
|
|
•
|
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 cabozantinib) that provide additional capital; and
|
|
•
|
our obligation to share U.S. marketing and commercialization costs for GDC-0973 (XL518) under our collaboration with Genentech.
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
Contract
|
|
|
|
|
|
|
|
||||||||
|
Research and development funding
|
$
|
—
|
|
|
$
|
0.6
|
|
|
$
|
—
|
|
|
$
|
14.0
|
|
|
Milestones
|
9.3
|
|
|
4.5
|
|
|
16.9
|
|
|
11.7
|
|
||||
|
License (1)
|
4.0
|
|
|
122.7
|
|
|
22.7
|
|
|
168.0
|
|
||||
|
Collaboration reimbursement
|
—
|
|
|
0.5
|
|
|
—
|
|
|
2.6
|
|
||||
|
Total revenues
|
$
|
13.3
|
|
|
$
|
128.3
|
|
|
$
|
39.6
|
|
|
$
|
196.3
|
|
|
Dollar change
|
$
|
(115.0
|
)
|
|
|
|
$
|
(156.7
|
)
|
|
|
||||
|
Percentage change
|
(89.6
|
)%
|
|
|
|
(79.8
|
)%
|
|
|
||||||
|
(1)
|
Includes amortization of up-front payments.
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
Sanofi
|
$
|
—
|
|
|
$
|
9.3
|
|
|
$
|
—
|
|
|
$
|
40.3
|
|
|
Bristol-Myers Squibb
|
7.8
|
|
|
119.0
|
|
|
23.4
|
|
|
153.3
|
|
||||
|
Daiichi Sankyo
|
5.5
|
|
|
—
|
|
|
5.5
|
|
|
—
|
|
||||
|
Boehringer Ingelheim
|
—
|
|
|
—
|
|
|
—
|
|
|
0.7
|
|
||||
|
Merck
|
—
|
|
|
—
|
|
|
10.7
|
|
|
—
|
|
||||
|
Genentech
|
—
|
|
|
—
|
|
|
—
|
|
|
2.0
|
|
||||
|
Total revenues
|
$
|
13.3
|
|
|
$
|
128.3
|
|
|
$
|
39.6
|
|
|
$
|
196.3
|
|
|
Dollar change
|
$
|
(115.0
|
)
|
|
|
|
$
|
(156.7
|
)
|
|
|
||||
|
Percentage change
|
(89.6
|
)%
|
|
|
|
(79.8
|
)%
|
|
|
||||||
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
Research and development expenses
|
$
|
30.7
|
|
|
$
|
37.5
|
|
|
$
|
96.4
|
|
|
$
|
126.1
|
|
|
Dollar change
|
$
|
(6.8
|
)
|
|
|
|
$
|
(29.7
|
)
|
|
|
||||
|
Percentage change
|
(18.1
|
)%
|
|
|
|
(23.5
|
)%
|
|
|
||||||
|
•
|
Clinical Trial Costs
— Clinical trial expenses, which include services performed by third-party contract research organizations and other vendors, decreased by $4.5 million, or 25%, and $18.7 million, or 31%, respectively,
primarily due to various cabozantinib clinical pharmacology studies that occurred in 2011 in support of our NDA filing for MTC, the gradual wind down of our randomized discontinuation trial for cabozantinib as well as the gradual wind down of EXAM, and the transfer of XL147 and XL765 to Sanofi. These decreases were partially offset by an increase in clinical trial activities for our COMET-1 and COMET-2 trials, as well as an increase in chemistry, manufacturing and control, or CMC, expenses associated with launch preparation and increases for various IST trials, resulting in a net decrease for the three and nine months ended September 30, 2012. We expect our clinical trial expenses to increase in the fourth quarter of 2012 due to continued increases in COMET-1 and COMET-2 clinical trial activities.
|
|
•
|
General Corporate Costs
— There was a decrease of $1.1 million, or 16%, and $4.5 million, or 21%, respectively, in the allocation of general corporate costs (such as facility costs, property taxes and insurance) to research and development, due to the decrease in research personnel related to the Restructurings, and the resulting decrease in allocated costs.
|
|
•
|
Personnel
— Personnel expense, which includes salaries, bonuses, related fringe benefits, recruiting, relocation costs and temporary employees, decreased by $1.4 million, or 16.4%, and $4.5 million, or 15.6%, respectively, primarily due to the reduction in headcount related to the Restructurings.
|
|
•
|
Stock-Based Compensation
— Stock-based compensation expense decreased by $0.4 million, or 30%, and $1.4 million, or 30%, respectively, primarily as a result of our reduction in headcount related to the Restructurings and lower fair value of options granted.
|
|
•
|
Lab Supplies
— Expenses related to lab supplies decreased $0.4 million, or 82%, and $0.8 million, or 52%, respectively, as a result of the Restructurings.
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
Inception
to date (1)
|
||||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
|
|||||||||||
|
Development
|
$
|
27.9
|
|
|
$
|
32.0
|
|
|
$
|
84.3
|
|
|
$
|
106.3
|
|
|
$
|
797.6
|
|
|
Drug discovery
|
1.8
|
|
|
4.0
|
|
|
8.8
|
|
|
14.3
|
|
|
465.3
|
|
|||||
|
Other
|
1.0
|
|
|
1.5
|
|
|
3.3
|
|
|
5.5
|
|
|
104.1
|
|
|||||
|
Total
|
$
|
30.7
|
|
|
$
|
37.5
|
|
|
$
|
96.4
|
|
|
$
|
126.1
|
|
|
$
|
1,367.0
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
General and administrative expenses
|
$
|
7.3
|
|
|
$
|
8.2
|
|
|
$
|
22.0
|
|
|
$
|
26.1
|
|
|
Dollar change
|
$
|
(0.8
|
)
|
|
|
|
$
|
(4.1
|
)
|
|
|
||||
|
Percentage change
|
(10.1
|
)%
|
|
|
|
(15.7
|
)%
|
|
|
||||||
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
Restructuring charges
|
$
|
0.7
|
|
|
$
|
2.9
|
|
|
$
|
1.7
|
|
|
$
|
6.2
|
|
|
Dollar change
|
$
|
(2.2
|
)
|
|
|
|
$
|
(4.5
|
)
|
|
|
||||
|
Percentage change
|
(75.0
|
)%
|
|
|
|
(72.5
|
)%
|
|
|
||||||
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
||||||||||||
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
||||||||
|
Total other income (expense), net
|
$
|
(7.4
|
)
|
|
$
|
(1.8
|
)
|
|
$
|
(15.0
|
)
|
|
$
|
(8.6
|
)
|
|
Dollar change
|
$
|
(5.5
|
)
|
|
|
|
$
|
(6.4
|
)
|
|
|
||||
|
Percentage change
|
(301.4
|
)%
|
|
|
|
(74.7
|
)%
|
|
|
||||||
|
|
Nine Months Ended September 30,
|
||||||
|
|
2012
|
|
2011
|
||||
|
Net (loss) income
|
$
|
(95,452
|
)
|
|
$
|
29,401
|
|
|
Adjustments to reconcile net (loss) income to net cash used in operating activities
|
22,226
|
|
|
22,150
|
|
||
|
Changes in operating assets and liabilities
|
(11,184
|
)
|
|
(181,610
|
)
|
||
|
Net cash used in operating activities
|
(84,410
|
)
|
|
(130,059
|
)
|
||
|
Net cash used in investing activities
|
(159,841
|
)
|
|
(88,838
|
)
|
||
|
Net cash provided by financing activities
|
478,799
|
|
|
187,668
|
|
||
|
Net increase (decrease) in cash and cash equivalents
|
234,548
|
|
|
(31,229
|
)
|
||
|
Cash and cash equivalents, at beginning of period
|
74,257
|
|
|
97,440
|
|
||
|
Cash and cash equivalents, at end of period
|
$
|
308,805
|
|
|
$
|
66,211
|
|
|
•
|
the progress and scope of the development and commercialization activities with respect to cabozantinib -- We are focusing our proprietary resources and development efforts on cabozantinib, our most advanced product candidate, which is being studied in a variety of tumor types, with the goal of rapidly commercializing the compound. Cabozantinib is being evaluated in a broad development program encompassing multiple cancer indications. Our development and commercialization plans for cabozantinib are dependent on the extent of our available financial resources. There can be no assurance that we will have sufficient financial resources independently or through other arrangements to fund the trials that are currently planned or in process, to fund other clinical trials that we may desire to initiate in the future or to fund commercialization efforts. If adequate funds are not available, we may be required to delay, discontinue or elect not to pursue one or more trials or commercialization efforts for cabozantinib;
|
|
•
|
repayment of the 2019 Notes -- The 2019 Notes mature on August 15, 2019, unless earlier converted, redeemed or repurchased and bear interest at a rate of 4.25% per annum, payable semi-annually in arrears on February 15 and August 15 of each year, beginning February 15, 2013. There can be no assurance that we will have sufficient funds to repay the 2019 Notes when due or satisfy our payment obligations under the Indenture;
|
|
•
|
repayment of the Deerfield Notes -- The outstanding principal amount of the Deerfield Notes bears interest in the annual amount of $6.0 million, payable quarterly in arrears. We are required to make certain mandatory prepayments on the Deerfield Notes on an annual basis in 2013, 2014 and 2015 and may also prepay all or a portion (not less than $5.0 million) of the principal amount of the Deerfield Notes during their term. There can be no assurance that we will have sufficient funds to repay the Deerfield Notes or satisfy our payment obligations under the note purchase agreement when due or that we will comply with the conditions to our ability to convert the principal amount of the Deerfield Notes into or satisfy our payment obligations with shares of our common stock;
|
|
•
|
repayment of our loan from Silicon Valley Bank -- Our loan and security agreement with Silicon Valley Bank provides for both equipment lines of credit and a seven-year term loan. The principal amount of $80.0 million outstanding under our term loan accrues interest at 1.0% per annum, which interest is due and payable monthly. We are required to repay the term loan in one balloon principal payment, representing 100% of the principal balance and accrued and unpaid interest, on May 31, 2017. We are required to repay any advances under an equipment line of credit in 48 equal monthly payments of principal and interest. We have the option to prepay all, but not less than all, of the amounts advanced under the term loan. We have the option to prepay without penalty any advance under an equipment line of credit other than advances under a single equipment line of credit, which has a 1.0% prepayment penalty, provided that we pay all unpaid accrued interest thereon that is due through the date of such prepayment. In accordance with the terms of the loan and security agreement, we are also required to maintain an amount equal to at least 100%, but not to exceed 107%, of the outstanding principal balance of the term loan and all equipment lines of credit under the loan and security agreement at all times in one or more accounts with Silicon Valley Bank and certain other designated financial institutions as support for our obligations under the loan and security agreement. As a result, the proceeds of the term loan cannot be used to satisfy our other obligations without causing a default under our loan and security agreement with Silicon Valley Bank;
|
|
•
|
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 cabozantinib) 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 and marketable securities 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 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.
|
|
•
|
Deerfield - Our note purchase agreement with Deerfield contains an event of default that would be triggered if our “cash and cash equivalents” fall below $20.0 million as of December 28, 2012, subject to a cure period. Upon such an event of default, Deerfield may declare all or a portion of the Put Price to be immediately due and payable. “Cash and cash equivalents” for purposes of our note purchase agreement includes our total cash, cash equivalents and short-term and long-term marketable securities. As of September 30, 2012, our “cash and cash equivalents” were $674.7 million.
|
|
•
|
Silicon Valley Bank - Our loan and security agreement with Silicon Valley Bank requires that we maintain an amount equal to at least 100%, but not to exceed 107%, of the outstanding principal balance of the term loan and all equipment lines of credit under the loan and security agreement at all times in one or more investment accounts with Silicon Valley Bank or one of its affiliates as support for our obligations under the loan and security agreement. If the balance on our deposit account(s) falls below the required level for more than 10 days, Silicon Valley Bank may declare all or part of the obligations under the loan and security agreement to be immediately due and payable and stop advancing money or extending credit to us.
|
|
ITEM 3.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
|
ITEM 4.
|
CONTROLS AND PROCEDURES
|
|
ITEM 1A.
|
RISK FACTORS
|
|
•
|
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 cabozantinib -- We are focusing our proprietary resources and development efforts on cabozantinib, our most advanced product candidate, which is being studied in a variety of tumor types, with the goal of rapidly commercializing the compound. Cabozantinib is being evaluated in a broad development program encompassing multiple cancer indications. The current clinical program for cabozantinib is focused on the treatment of CRPC and MTC and will be expanded to other solid tumor indications, based on encouraging interim data that have emerged from the RDT investigating cabozantinib in nine distinct tumor types and other clinical trials. In October 2011, we announced that our EXAM phase 3 clinical trial of cabozantinib in MTC met its primary endpoint and on July 30, 2012, we announced that the
|
|
•
|
repayment of the 2019 Notes -- On August 14, 2012, we issued and sold $287.5 million aggregate principal amount of the 2019 Notes for net proceeds of $277.7 million. The 2019 Notes mature on August 15, 2019, unless earlier converted, redeemed or repurchased and bear interest at a rate of 4.25% per annum, payable semi-annually in arrears on February 15 and August 15 of each year, beginning February 15, 2013. Subject to certain terms and conditions, at any time on or after August 15, 2016, we may redeem for cash all or a portion of the 2019 Notes. The redemption price will equal 100% of the principal amount of the 2019 Notes to be redeemed plus accrued and unpaid interest, if any, to, but excluding, the redemption date. Upon the occurrence of certain circumstances, holders may convert their 2019 Notes prior to the close of business on the business day immediately preceding May 15, 2019. On or after May 15, 2019, until the close of business on the second trading day immediately preceding August 15, 2019, holders may surrender their 2019 Notes for conversion at any time. Upon conversion, we will pay or deliver, as the case may be, cash, shares of our common stock or a combination of cash and shares of our common stock, at our election. The initial conversion rate of 188.2353 shares of common stock per $1,000 principal amount of the 2019 Notes is equivalent to a conversion price of approximately $5.31 per share of common stock and is subject to adjustment in connection with certain events. If a “Fundamental Change” (as defined in the Indenture) occurs, holders of the 2019 Notes may require us to purchase for cash all or any portion of their 2019 Notes at a purchase price equal to 100% of the principal amount of the Notes to be purchased plus accrued and unpaid interest, if any, to, but excluding, the Fundamental Change purchase date. In addition, if certain bankruptcy and insolvency-related events of defaults occur, the principal of, and accrued and unpaid interest on, all of the then outstanding notes shall automatically become due and payable. If an event of default other than certain bankruptcy and insolvency-related events of defaults occurs and is continuing, the Trustee by notice to us or the holders of at least 25% in principal amount of the outstanding 2019 Notes by notice to us and the Trustee, may declare the principal of, and accrued and unpaid interest on, all of the then outstanding 2019 Notes to be due and payable. There can be no assurance that we will have sufficient funds to repay the 2019 Notes when due or satisfy our payment obligations under the Indenture;
|
|
•
|
repayment of the Deerfield Notes -- On June 2, 2010, we entered into a note purchase agreement with Deerfield, pursuant to which, on July 1, 2010, we sold to Deerfield an aggregate of $124.0 million initial principal amount of the Deerfield Notes, for an aggregate purchase price of $80.0 million, less closing fees and expenses of $2.0 million. On August 6, 2012, the parties amended the note purchase agreement to permit the issuance of the 2019 Notes and modify certain optional prepayment rights. The amendment became effective upon the issuance of the 2019 Notes and the payment to Deerfield of a $1.5 million consent fee. The outstanding principal amount of the Deerfield Notes bears interest in the annual amount of $6.0 million, payable quarterly in arrears. We will be required to make mandatory prepayments on the Deerfield Notes on an annual basis in 2013, 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 payments due in January 2013 and 2014, a minimum prepayment amount of $10.0 million. We may also prepay all or a portion (not less than $5.0 million) of the principal amount of the Deerfield Notes at an optional prepayment price based on a discounted principal amount (during the first three years of the term, subject to a prepayment premium) determined as of the date of prepayment, plus accrued and unpaid interest, plus in the case of a prepayment of the full principal amount of the Deerfield Notes (other than prepayments upon the occurrence of specified transactions relating to a change of control or a substantial sale of assets), all accrued interest that would have accrued between the date of such prepayment and the next anniversary of the note purchase agreement. Pursuant to the amendment of the note purchase agreement, any optional prepayment of the Deerfield Notes made on or prior to July 2, 2013 will be determined as if such prepayment occurred as of July 3, 2013. In lieu of making any optional or mandatory prepayment in cash, subject to specified limitations (including a cap on the number of shares issuable under the note purchase agreement), we have the right to convert all or a portion of the principal amount of the Deerfield Notes into, or satisfy all or any portion of the optional prepayment amounts or mandatory prepayment amounts
|
|
•
|
repayment of our loan from Silicon Valley Bank -- On May 22, 2002, we entered into a loan and security agreement with Silicon Valley Bank for an equipment line of credit. On December 21, 2004, December 21, 2006 and December 21, 2007, we amended the loan and security agreement to provide for additional equipment lines of credit and on June 2, 2010, we further amended the loan and security agreement to provide for a new seven-year term loan in an amount of $80.0 million. The principal amount outstanding under the term loan accrues interest at 1.0% per annum, which interest is due and payable monthly. We are required to repay the term loan in one balloon principal payment, representing 100% of the principal balance and accrued and unpaid interest, on May 31, 2017. We are required to repay any advances under an equipment line of credit in 48 equal monthly payments of principal and interest. We have the option to prepay all, but not less than all, of the amounts advanced under the term loan, provided that we pay all unpaid accrued interest thereon that is due through the date of such prepayment and the interest on the entire principal balance of the term loan that would otherwise have been paid after such prepayment date until the maturity date of the term loan. We have the option to prepay without penalty any advance under an equipment line of credit other than advances under a single equipment line of credit, which has a 1.0% prepayment penalty, provided that we pay all unpaid accrued interest thereon that is due through the date of such prepayment. In accordance with the terms of the loan and security agreement, we are also required to maintain an amount equal to at least 100%, but not to exceed 107%, of the outstanding principal balance of the term loan and all equipment lines of credit under the loan and security agreement at all times in one or more accounts with Silicon Valley Bank and certain other designated financial institutions as support for our obligations under the loan and security agreement. As a result, the proceeds of the term loan cannot be used to satisfy our other obligations without causing a default under our loan and security agreement with Silicon Valley Bank;
|
|
•
|
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 cabozantinib) 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 and marketable securities 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 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 following a Fundamental Change or 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.
|
|
•
|
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 that ultimately participate in the clinical trial;
|
|
•
|
the duration of patient follow-up that is appropriate in view of the results;
|
|
•
|
the number of clinical sites included in the trials; and
|
|
•
|
the length of time required to enroll suitable patient subjects.
|
|
•
|
we may not be able to control the amount of U.S. marketing and commercialization costs for 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 will devote to the development or commercialization of drug candidates or to their marketing and distribution;
|
|
•
|
we may not be able to control the amount and timing of resources that our potential future collaborators may 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
|
|
•
|
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.
|
|
•
|
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 a new drug application, 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.
|
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology and Clinical Health Act, or HITECH, 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 recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
|
|
•
|
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; and
|
|
•
|
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 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;
|
|
•
|
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 marketing and distribution support; and
|
|
•
|
sufficient third-party coverage or reimbursement.
|
|
•
|
the progress and scope of our research and development activities;
|
|
•
|
recognition of up-front licensing or other fees or revenues;
|
|
•
|
payments of non-refundable up-front 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 our restructurings; and
|
|
•
|
general and industry-specific economic conditions that may affect our collaborators' research and development expenditures.
|
|
•
|
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 timing of achievement of our clinical, regulatory, partnering and other milestones, such as the commencement
|
|
•
|
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;
|
|
•
|
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 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;
|
|
•
|
limitations on the removal of directors; and
|
|
•
|
advance notice requirements for director nominations and stockholder proposals.
|
|
ITEM 2.
|
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
|
Period
|
(a) Total
Number of
Shares (or
Units)
Purchased
|
|
(b) Average Price
Paid per Share (or
Unit)
|
|
(c) Total Number of
Shares (or Units)
Purchased as Part of
Publicly Announced
Plans or Programs
|
|
(d) Maximum
Number (or
Approximate Dollar
Value) of Shares (or
Units) that May Yet
Be Purchased Under
the Plans or
Programs
|
|
Month #1 (June 30, 2012 –
July 27, 2012) |
—
|
|
—
|
|
—
|
|
—
|
|
Month #2 (July 28, 2012 –
August 24, 2012) |
29,845
|
|
$4.44
|
|
—
|
|
—
|
|
Month #3 (August 25, 2012 –
September 28, 2012) |
—
|
|
—
|
|
—
|
|
—
|
|
Total
|
29,845
|
|
$4.44
|
|
—
|
|
—
|
|
ITEM 6.
|
EXHIBITS
|
|
|
(a) Exhibits
|
|
|
The exhibits listed on the accompanying exhibit index are filed or incorporated by reference (as stated therein) as part of this Quarterly Report on Form 10-Q.
|
|
Date: November 7, 2012
|
|
EXELIXIS, INC.
|
|
|
|
|
|
|
|
/s/ Frank Karbe
|
|
|
|
Frank Karbe
Executive Vice President and Chief Financial Officer
(Duly Authorized Officer and Principal Financial and Accounting Officer)
|
|
|
|
|
|
Incorporation by Reference
|
|
|
||||||
|
Exhibit
Number
|
|
Exhibit Description
|
|
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
Filed
Herewith
|
|
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
|
|
Consent and Amendment dated August 6, 2012 to Note Purchase Agreement, dated June 2, 2010, by and between Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P. and Exelixis, Inc.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
8/6/2012
|
|
|
|
10.2
|
|
Pledge and Escrow Agreement dated August 14, 2012 by and among Exelixis, Inc., Wells Fargo Bank, National Association and Wells Fargo Bank, National Association.
|
|
8-K
|
|
000-30235
|
|
10.1
|
|
8/14/2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incorporation by Reference
|
|
|
||||||
|
Exhibit
Number
|
|
Exhibit Description
|
|
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
Filed
Herewith
|
|
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
|
|
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.
|
|
‡
|
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.
|
|
#
|
Pursuant to applicable securities laws and regulations, we are deemed to have complied with the reporting obligation relating to the submission of interactive data files in such exhibits and are not subject to liability under any anti-fraud provisions of the federal securities laws as long as we have made a good faith attempt to comply with the submission requirements and promptly amend the interactive data files after becoming aware that the interactive data files fail to comply with the submission requirements. In accordance with Rule 406T of Regulation S-T, the information in these exhibits is furnished and deemed not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, except as expressly set forth by specific reference 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 |
|---|