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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||
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Item 4.
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||
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Item 1.
|
||
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Item 1A.
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||
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Item 2.
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||
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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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March 31,
2015 |
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December 31, 2014*
|
||||
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(unaudited)
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|
|||||
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ASSETS
|
|
|
|
||||
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Current assets:
|
|
|
|
||||
|
Cash and cash equivalents
|
$
|
84,987
|
|
|
$
|
80,395
|
|
|
Short-term investments
|
22,258
|
|
|
63,890
|
|
||
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Short-term restricted cash and investments
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6,108
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|
|
12,212
|
|
||
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Trade and other receivables
|
3,882
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|
|
4,882
|
|
||
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Inventory
|
2,593
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|
|
2,381
|
|
||
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Prepaid expenses and other current assets
|
5,212
|
|
|
3,481
|
|
||
|
Total current assets
|
125,040
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|
|
167,241
|
|
||
|
Long-term investments
|
81,597
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|
|
81,579
|
|
||
|
Long-term restricted cash and investments
|
2,684
|
|
|
4,684
|
|
||
|
Property and equipment, net
|
2,158
|
|
|
2,432
|
|
||
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Goodwill
|
63,684
|
|
|
63,684
|
|
||
|
Other assets
|
7,771
|
|
|
8,340
|
|
||
|
Total assets
|
$
|
282,934
|
|
|
$
|
327,960
|
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
|
|
|
||||
|
Current liabilities:
|
|
|
|
||||
|
Accounts payable
|
$
|
1,303
|
|
|
$
|
6,413
|
|
|
Accrued clinical trial liabilities
|
30,976
|
|
|
41,545
|
|
||
|
Accrued compensation and benefits
|
3,459
|
|
|
3,350
|
|
||
|
Other accrued liabilities
|
13,867
|
|
|
12,282
|
|
||
|
Current portion of convertible notes
|
3,911
|
|
|
98,880
|
|
||
|
Current portion of loans payable
|
164
|
|
|
381
|
|
||
|
Current portion of restructuring
|
4,993
|
|
|
6,426
|
|
||
|
Deferred revenue
|
7
|
|
|
2,583
|
|
||
|
Total current liabilities
|
58,680
|
|
|
171,860
|
|
||
|
Long-term portion of convertible notes
|
284,355
|
|
|
182,395
|
|
||
|
Long-term portion of loans payable
|
80,000
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|
|
80,000
|
|
||
|
Long-term portion of restructuring
|
3,697
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|
|
4,365
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|
||
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Other long-term liabilities
|
2,961
|
|
|
4,169
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|
||
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Total liabilities
|
429,693
|
|
|
442,789
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|
||
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Commitments
|
|
|
|
||||
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Stockholders’ deficit:
|
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|
||||
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Preferred stock
|
—
|
|
|
—
|
|
||
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Common stock, $0.001 par value; 400,000,000 shares authorized; issued and outstanding:
196,020,856 and 195,895,769 shares at March 31, 2015 and December 31, 2014, respectively |
196
|
|
|
196
|
|
||
|
Additional paid-in capital
|
1,655,580
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|
1,652,400
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|
||
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Accumulated other comprehensive loss
|
(61
|
)
|
|
(121
|
)
|
||
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Accumulated deficit
|
(1,802,474
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)
|
|
(1,767,304
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)
|
||
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Total stockholders’ deficit
|
(146,759
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)
|
|
(114,829
|
)
|
||
|
Total liabilities and stockholders’ deficit
|
$
|
282,934
|
|
|
$
|
327,960
|
|
|
*
|
The condensed consolidated balance sheet as of December 31, 2014 has been derived from the audited financial statements as of that date.
|
|
|
Three Months Ended March 31,
|
||||||
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2015
|
|
2014
|
||||
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Revenues:
|
|
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|
||||
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Net product revenues
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$
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9,388
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$
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4,905
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Operating expenses:
|
|
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|
||||
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Cost of goods sold
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766
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|
309
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|
||
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Research and development
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22,282
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|
|
54,847
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|
||
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Selling, general and administrative
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9,531
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|
|
14,691
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|
||
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Restructuring (recovery) charge
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(431
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)
|
|
46
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|
||
|
Total operating expenses
|
32,148
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|
|
69,893
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|
||
|
Loss from operations
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(22,760
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)
|
|
(64,988
|
)
|
||
|
Other income (expense), net:
|
|
|
|
||||
|
Interest income and other, net
|
(7
|
)
|
|
2,131
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|
||
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Interest expense
|
(12,403
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)
|
|
(11,762
|
)
|
||
|
Total other income (expense), net
|
(12,410
|
)
|
|
(9,631
|
)
|
||
|
Net loss
|
$
|
(35,170
|
)
|
|
$
|
(74,619
|
)
|
|
Net loss per share, basic and diluted
|
$
|
(0.18
|
)
|
|
$
|
(0.39
|
)
|
|
Shares used in computing basic and diluted net loss per share
|
195,904
|
|
|
191,699
|
|
||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Net loss
|
$
|
(35,170
|
)
|
|
$
|
(74,619
|
)
|
|
Other comprehensive income (1)
|
60
|
|
|
7
|
|
||
|
Comprehensive loss
|
$
|
(35,110
|
)
|
|
$
|
(74,612
|
)
|
|
(1)
|
Other comprehensive income 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.
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net loss
|
$
|
(35,170
|
)
|
|
$
|
(74,619
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
|
Depreciation and amortization
|
297
|
|
|
498
|
|
||
|
Stock-based compensation expense
|
1,660
|
|
|
3,758
|
|
||
|
Accretion of debt discount
|
7,675
|
|
|
6,988
|
|
||
|
Gain on sale of equity investment
|
(95
|
)
|
|
—
|
|
||
|
Change in the fair value of warrants
|
549
|
|
|
(1,739
|
)
|
||
|
Other
|
637
|
|
|
1,475
|
|
||
|
Changes in assets and liabilities:
|
|
|
|
||||
|
Trade and other receivables
|
1,292
|
|
|
(516
|
)
|
||
|
Inventory
|
(212
|
)
|
|
204
|
|
||
|
Prepaid expenses and other assets
|
(1,846
|
)
|
|
(364
|
)
|
||
|
Accounts payable, accrued compensation, and other accrued liabilities
|
(3,416
|
)
|
|
(10,254
|
)
|
||
|
Clinical trial liabilities
|
(10,569
|
)
|
|
4,160
|
|
||
|
Restructuring liability
|
(3,024
|
)
|
|
(1,241
|
)
|
||
|
Other long-term liabilities
|
(288
|
)
|
|
(229
|
)
|
||
|
Deferred revenue
|
(2,576
|
)
|
|
(207
|
)
|
||
|
Net cash used in operating activities
|
(45,086
|
)
|
|
(72,086
|
)
|
||
|
Cash flows from investing activities:
|
|
|
|
||||
|
Purchases of property and equipment
|
(31
|
)
|
|
(384
|
)
|
||
|
Proceeds from sale of property and equipment
|
639
|
|
|
276
|
|
||
|
Proceeds from sale of equity investment
|
95
|
|
|
—
|
|
||
|
Proceeds from maturities of restricted cash and investments
|
10,748
|
|
|
6,598
|
|
||
|
Purchase of restricted cash and investments
|
(2,684
|
)
|
|
(504
|
)
|
||
|
Proceeds from maturities of investments
|
54,410
|
|
|
90,311
|
|
||
|
Purchases of investments
|
(13,282
|
)
|
|
(35,937
|
)
|
||
|
Net cash provided by investing activities
|
49,895
|
|
|
60,360
|
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Proceeds from issuance of common stock, net
|
—
|
|
|
75,646
|
|
||
|
Proceeds from exercise of stock options and warrants
|
—
|
|
|
120
|
|
||
|
Principal payments on debt
|
(217
|
)
|
|
(10,479
|
)
|
||
|
Net cash (used in) provided by financing activities
|
(217
|
)
|
|
65,287
|
|
||
|
Net increase in cash and cash equivalents
|
4,592
|
|
|
53,561
|
|
||
|
Cash and cash equivalents at beginning of period
|
80,395
|
|
|
103,978
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
84,987
|
|
|
$
|
157,539
|
|
|
|
|
Employee Severance and Other Benefits
|
|
Asset Impairment and Other
|
|
Total
|
||||||
|
Restructuring liability as of December 31, 2014
|
|
$
|
1,290
|
|
|
$
|
47
|
|
|
$
|
1,337
|
|
|
Restructuring (recovery) charge
|
|
5
|
|
|
(853
|
)
|
|
(848
|
)
|
|||
|
Cash (payments) receipts, net
|
|
(1,003
|
)
|
|
552
|
|
|
(451
|
)
|
|||
|
Other non-cash items
|
|
—
|
|
|
298
|
|
|
298
|
|
|||
|
Restructuring liability for 2014 Restructuring as of March 31, 2015
|
|
$
|
292
|
|
|
$
|
44
|
|
|
$
|
336
|
|
|
|
|
Facility
Charges
|
||
|
Restructuring liability as of December 31, 2014
|
|
$
|
9,454
|
|
|
Restructuring charge
|
|
415
|
|
|
|
Cash payments
|
|
(1,515
|
)
|
|
|
Restructuring liability for 2010 Restructurings as of March 31, 2015
|
|
$
|
8,354
|
|
|
|
March 31, 2015
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Cash and cash equivalents
|
$
|
84,988
|
|
|
$
|
—
|
|
|
$
|
(1
|
)
|
|
$
|
84,987
|
|
|
Short-term investments
|
22,274
|
|
|
31
|
|
|
(47
|
)
|
|
22,258
|
|
||||
|
Short-term restricted cash and investments
|
6,041
|
|
|
67
|
|
|
—
|
|
|
6,108
|
|
||||
|
Long-term investments
|
81,600
|
|
|
—
|
|
|
(3
|
)
|
|
81,597
|
|
||||
|
Long-term restricted cash and investments
|
2,684
|
|
|
—
|
|
|
—
|
|
|
2,684
|
|
||||
|
Total cash and investments
|
$
|
197,587
|
|
|
$
|
98
|
|
|
$
|
(51
|
)
|
|
$
|
197,634
|
|
|
|
December 31, 2014
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Cash and cash equivalents
|
$
|
80,395
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
80,395
|
|
|
Short-term investments
|
63,988
|
|
|
37
|
|
|
(135
|
)
|
|
63,890
|
|
||||
|
Short-term restricted cash and investments
|
12,105
|
|
|
107
|
|
|
—
|
|
|
12,212
|
|
||||
|
Long-term investments
|
81,600
|
|
|
1
|
|
|
(22
|
)
|
|
81,579
|
|
||||
|
Long-term restricted cash and investments
|
4,684
|
|
|
—
|
|
|
—
|
|
|
4,684
|
|
||||
|
Total cash and investments
|
$
|
242,772
|
|
|
$
|
145
|
|
|
$
|
(157
|
)
|
|
$
|
242,760
|
|
|
|
March 31, 2015
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Money market funds
|
$
|
36,841
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
36,841
|
|
|
Commercial paper
|
52,724
|
|
|
—
|
|
|
(1
|
)
|
|
52,723
|
|
||||
|
Corporate bonds
|
98,280
|
|
|
32
|
|
|
(50
|
)
|
|
98,262
|
|
||||
|
U.S. Treasury and government sponsored enterprises
|
6,041
|
|
|
66
|
|
|
—
|
|
|
6,107
|
|
||||
|
Total investments
|
$
|
193,886
|
|
|
$
|
98
|
|
|
$
|
(51
|
)
|
|
$
|
193,933
|
|
|
|
December 31, 2014
|
||||||||||||||
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
|
Money market funds
|
$
|
23,376
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
23,376
|
|
|
Commercial paper
|
56,714
|
|
|
—
|
|
|
—
|
|
|
56,714
|
|
||||
|
Corporate bonds
|
143,444
|
|
|
35
|
|
|
(157
|
)
|
|
143,322
|
|
||||
|
U.S. Treasury and government sponsored enterprises
|
12,105
|
|
|
107
|
|
|
—
|
|
|
12,212
|
|
||||
|
Municipal bonds
|
2,659
|
|
|
3
|
|
|
—
|
|
|
2,662
|
|
||||
|
Total investments
|
$
|
238,298
|
|
|
$
|
145
|
|
|
$
|
(157
|
)
|
|
$
|
238,286
|
|
|
|
Mature within One Year
|
|
After One Year through Two Years
|
|
Fair Value
|
||||||
|
Money market funds
|
$
|
36,841
|
|
|
$
|
—
|
|
|
$
|
36,841
|
|
|
Commercial paper
|
52,723
|
|
|
—
|
|
|
52,723
|
|
|||
|
Corporate bonds
|
95,529
|
|
|
2,733
|
|
|
98,262
|
|
|||
|
U.S. Treasury and government sponsored enterprises
|
6,107
|
|
|
—
|
|
|
6,107
|
|
|||
|
Total investments
|
$
|
191,200
|
|
|
$
|
2,733
|
|
|
$
|
193,933
|
|
|
|
March 31,
2015 |
|
December 31,
2014 |
||||
|
Raw materials
|
$
|
1,076
|
|
|
$
|
1,118
|
|
|
Work in process
|
2,964
|
|
|
2,845
|
|
||
|
Finished goods
|
787
|
|
|
559
|
|
||
|
Total
|
4,827
|
|
|
4,522
|
|
||
|
Less: non-current portion included in other assets
|
(2,234
|
)
|
|
(2,141
|
)
|
||
|
Inventory
|
$
|
2,593
|
|
|
$
|
2,381
|
|
|
|
March 31,
2015 |
|
December 31,
2014 |
||||
|
Convertible Senior Subordinated Notes due 2019
|
$
|
186,940
|
|
|
$
|
182,395
|
|
|
Secured Convertible Notes due 2015
|
101,326
|
|
|
98,880
|
|
||
|
Silicon Valley Bank term loan
|
80,000
|
|
|
80,000
|
|
||
|
Silicon Valley Bank line of credit
|
164
|
|
|
381
|
|
||
|
Total debt
|
368,430
|
|
|
361,656
|
|
||
|
Less: current portion
|
(4,075
|
)
|
|
(99,261
|
)
|
||
|
Long-term debt
|
$
|
364,355
|
|
|
$
|
262,395
|
|
|
|
March 31,
2015 |
|
December 31,
2014 |
||||
|
Net carrying amount of the liability component
|
$
|
186,940
|
|
|
$
|
182,395
|
|
|
Unamortized discount of the liability component
|
100,560
|
|
|
105,105
|
|
||
|
Face amount of the 2019 Notes
|
$
|
287,500
|
|
|
$
|
287,500
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Stated coupon interest
|
$
|
3,055
|
|
|
$
|
3,089
|
|
|
Amortization of debt discount and debt issuance costs
|
4,721
|
|
|
4,295
|
|
||
|
Total interest expense
|
$
|
7,776
|
|
|
$
|
7,384
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Stated coupon interest
|
$
|
1,479
|
|
|
$
|
1,480
|
|
|
Amortization of debt discount and debt issuance costs
|
2,947
|
|
|
2,695
|
|
||
|
Total interest expense
|
$
|
4,426
|
|
|
$
|
4,175
|
|
|
|
March 31, 2015
|
||||||||||
|
|
Level 1
|
|
Level 2
|
|
Total
|
||||||
|
Money market funds
|
$
|
36,841
|
|
|
$
|
—
|
|
|
$
|
36,841
|
|
|
Commercial paper
|
—
|
|
|
52,723
|
|
|
52,723
|
|
|||
|
Corporate bonds
|
—
|
|
|
98,262
|
|
|
98,262
|
|
|||
|
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
6,107
|
|
|
6,107
|
|
|||
|
Total financial assets
|
$
|
36,841
|
|
|
$
|
157,092
|
|
|
$
|
193,933
|
|
|
|
December 31, 2014
|
||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
Financial assets:
|
|
|
|
|
|
|
|
||||||||
|
Money market funds
|
$
|
23,376
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
23,376
|
|
|
Commercial paper
|
—
|
|
|
56,714
|
|
|
—
|
|
|
56,714
|
|
||||
|
Corporate bonds
|
—
|
|
|
143,322
|
|
|
—
|
|
|
143,322
|
|
||||
|
U.S. Treasury and government sponsored enterprises
|
—
|
|
|
12,212
|
|
|
—
|
|
|
12,212
|
|
||||
|
Municipal bonds
|
—
|
|
|
2,662
|
|
|
—
|
|
|
2,662
|
|
||||
|
Total financial assets
|
$
|
23,376
|
|
|
$
|
214,910
|
|
|
$
|
—
|
|
|
$
|
238,286
|
|
|
Financial liabilities:
|
|
|
|
|
|
|
|
||||||||
|
Warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
921
|
|
|
$
|
921
|
|
|
Total financial liabilities
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
921
|
|
|
$
|
921
|
|
|
Balance at December 31, 2014
|
$
|
921
|
|
|
Unrealized loss
at final re-measurement of warrants on March 18, 2015,
included in Interest income and other, net
|
549
|
|
|
|
Transfer of warrant from Other long-term liabilities to Additional paid-in capital at their estimated fair value upon warrant repricing on March 18, 2015
|
(1,470
|
)
|
|
|
Balance at March 31, 2015
|
$
|
—
|
|
|
|
March 31, 2015
|
|
December 31, 2014
|
||||||||||||
|
|
Carrying
Amount
|
|
Fair Value
|
|
Carrying
Amount
|
|
Fair Value
|
||||||||
|
2019 Notes
|
$
|
186,940
|
|
|
$
|
217,034
|
|
|
$
|
182,395
|
|
|
$
|
156,889
|
|
|
Silicon Valley Bank term loan
|
$
|
80,000
|
|
|
$
|
79,916
|
|
|
$
|
80,000
|
|
|
$
|
79,943
|
|
|
Silicon Valley Bank line of credit
|
$
|
164
|
|
|
$
|
164
|
|
|
$
|
381
|
|
|
$
|
381
|
|
|
•
|
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.
|
|
•
|
The 2019 Notes are valued using a third-party pricing model that is based in part on average trading prices, which is a Level 2 input. The 2019 Notes are not marked-to-market and are shown at their initial fair value less the unamortized discount; the portion of the value allocated to the conversion option is included in Stockholders’ deficit on the accompanying Consolidated Balance Sheets.
|
|
•
|
We estimate the fair value of our other debt instruments, where possible, using the net present value of the payments discounted at an interest rate that is consistent with money-market rates that would have been earned on our non-interest-bearing compensating balances, which is a Level 2 input.
|
|
•
|
The 2014 Deerfield Warrants are valued using a Monte Carlo simulation model until December 31, 2014 and the Black-Scholes Merton option pricing model on March 18, 2015. The expected life is based on the contractual terms of the 2014 Deerfield Warrants, and in certain simulations, assumes the
two
year extension that would result from our exercise of the Extension Option; as of and subsequent to September 30, 2014, we estimated that it was probable that we would exercise this two-year extension. We consider implied volatility as well as our historical volatility in developing our estimate of expected volatility. The fair value of the 2014 Deerfield Warrants was estimated using the following assumptions, which, except for risk-free interest rate, are Level 3 inputs (dollars in thousands):
|
|
|
March 18, 2015
|
|
December 31, 2014
|
|
January 22, 2014
(issuance date)
|
||||||
|
Fair value of warrants
|
$
|
1,470
|
|
|
$
|
921
|
|
|
$
|
2,762
|
|
|
Risk-free interest rate
|
0.87
|
%
|
|
1.07
|
%
|
|
0.95
|
%
|
|||
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|||
|
Volatility
|
95
|
%
|
|
96
|
%
|
|
57
|
%
|
|||
|
Average expected life
|
2.8 years
|
|
|
3.1 years
|
|
|
3.2 years
|
|
|||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Research and development expense
|
$
|
627
|
|
|
$
|
1,565
|
|
|
Selling, general and administrative expense
|
1,033
|
|
|
2,193
|
|
||
|
Total employee stock-based compensation expense
|
$
|
1,660
|
|
|
$
|
3,758
|
|
|
|
Stock Options
|
||||||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Weighted average grant-date fair value
|
$
|
1.35
|
|
|
$
|
4.70
|
|
|
Risk-free interest rate
|
1.20
|
%
|
|
1.59
|
%
|
||
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
||
|
Volatility
|
95
|
%
|
|
81
|
%
|
||
|
Expected life
|
4.5 years
|
|
|
5.5 years
|
|
||
|
|
Employee Stock Purchase Plan
|
||||||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Weighted average grant-date fair value
|
$
|
0.70
|
|
|
$
|
1.59
|
|
|
Risk-free interest rate
|
0.11
|
%
|
|
0.08
|
%
|
||
|
Dividend yield
|
—
|
%
|
|
—
|
%
|
||
|
Volatility
|
96
|
%
|
|
62
|
%
|
||
|
Expected life
|
6 months
|
|
|
6 months
|
|
||
|
|
Shares
|
|
Weighted
Average
Exercise Price
|
|
Weighted
Average
Remaining Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
Options outstanding at December 31, 2014
|
27,811,992
|
|
|
$
|
5.00
|
|
|
|
|
|
||
|
Granted
|
4,235,450
|
|
|
$
|
1.94
|
|
|
|
|
|
||
|
Forfeited
|
(291,543
|
)
|
|
$
|
4.13
|
|
|
|
|
|
||
|
Expired
|
(3,154,051
|
)
|
|
$
|
6.06
|
|
|
|
|
|
||
|
Options outstanding at March 31, 2015
|
28,601,848
|
|
|
$
|
4.44
|
|
|
4.89 years
|
|
$
|
11,313
|
|
|
Exercisable March 31, 2015
|
12,737,971
|
|
|
$
|
6.86
|
|
|
3.02 years
|
|
$
|
—
|
|
|
|
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|||||
|
Awards outstanding at December 31, 2014
|
961,469
|
|
|
$
|
3.82
|
|
|
|
|
|
||
|
Awarded
|
65,124
|
|
|
$
|
2.88
|
|
|
|
|
|
||
|
Released
|
(111,334
|
)
|
|
$
|
1.95
|
|
|
|
|
|
||
|
Forfeited
|
(89,773
|
)
|
|
$
|
5.29
|
|
|
|
|
|
||
|
Awards outstanding at March 31, 2015
|
825,486
|
|
|
$
|
3.84
|
|
|
1.84 years
|
|
$
|
2,196
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Numerator:
|
|
|
|
||||
|
Net loss
|
$
|
(35,170
|
)
|
|
$
|
(74,619
|
)
|
|
Denominator:
|
|
|
|
||||
|
Shares used in computing basic and diluted net loss per share
|
195,904
|
|
|
191,699
|
|
||
|
Net loss per share, basic and diluted
|
$
|
(0.18
|
)
|
|
$
|
(0.39
|
)
|
|
|
March 31,
|
||||
|
|
2015
|
|
2014
|
||
|
Convertible debt
|
88,008
|
|
|
54,123
|
|
|
Outstanding stock options, unvested RSUs and ESPP contributions
|
29,591
|
|
|
26,302
|
|
|
Warrants
|
1,000
|
|
|
2,186
|
|
|
Total potentially dilutive shares
|
118,599
|
|
|
82,611
|
|
|
|
Three Months Ended March 31,
|
||||
|
|
2015
|
|
2014
|
||
|
Percentage of revenues earned in the United States
|
86
|
%
|
|
98
|
%
|
|
Percentage of revenues earned in the European Union
|
14
|
%
|
|
2
|
%
|
|
|
Three Months Ended March 31,
|
||||
|
|
2015
|
|
2014
|
||
|
Diplomat Specialty Pharmacy
|
86
|
%
|
|
98
|
%
|
|
Swedish Orphan Biovitrum
|
14
|
%
|
|
2
|
%
|
|
•
|
A Study of MEHD7945A and Cobimetinib (GDC-0973) in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS (NCT01986166);
|
|
•
|
A Phase 1b Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors (NCT01988896);
|
|
•
|
Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAF V600 Mutant Melanoma (NCT01495988);
|
|
•
|
A Phase 1b Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Combination With Vemurafenib (Zelboraf®) or Vemurafenib Plus Cobimetinib in Patients With Previously Untreated BRAF V600-Mutation Positive Metastatic Melanoma (NCT01656642);
|
|
•
|
A Study of Cobimetinib in Combination With Paclitaxel as First-line Treatment for Patients With Metastatic Triple-negative Breast Cancer (NCT02322814);
|
|
•
|
A Study of Neo-adjuvant Use of Vemurafenib Plus Cobimetinib for BRAF Mutant Melanoma With Palpable Lymph Node Metastases (NCT02036086);
|
|
•
|
A Phase II Study of Cobimetinib in Combination with Vemurafenib in Active Melanoma Brain Metastases (CoBRIM-B) (NCT02230306);
|
|
•
|
Neoadjuvant Vemurafenib + Cobimetinib in Melanoma: NEO-VC (NCT02303951); and
|
|
•
|
Vemurafenib Plus Cobimetinib in Metastatic Melanoma (REPOSIT) (NCT02414750).
|
|
•
|
Prior to July 1, 2015: we may prepay all of the principal amount of the Deerfield Notes at any time at a prepayment price equal to the outstanding principal amount, plus accrued and unpaid interest through the date of
|
|
•
|
If the expected extension occurs: we may at our sole discretion, prepay all of the principal amount of the Deerfield Notes at a prepayment price equal to 105% of the outstanding principal amount of the Deerfield Notes, plus all accrued and unpaid interest through the date of such prepayment, plus, if prior to July 1, 2017, all interest that would have accrued on the principal amount of the Deerfield Notes between the date of such prepayment and July 1, 2017, if the outstanding principal amount of the Deerfield Notes as of such prepayment date had remained outstanding through July 1, 2017, plus all other accrued and unpaid obligations, collectively referred to as the Prepayment Price.
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Gross product revenues
|
$
|
10,133
|
|
|
$
|
5,241
|
|
|
Discounts and allowances
|
(745
|
)
|
|
(336
|
)
|
||
|
Total revenues
|
$
|
9,388
|
|
|
$
|
4,905
|
|
|
Dollar change
|
$
|
4,483
|
|
|
|
|
|
|
Percentage change
|
91
|
%
|
|
|
|
||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Diplomat Specialty Pharmacy
|
$
|
8,075
|
|
|
$
|
4,825
|
|
|
Sobi
|
1,313
|
|
|
80
|
|
||
|
Total revenues
|
$
|
9,388
|
|
|
$
|
4,905
|
|
|
Dollar change
|
$
|
4,483
|
|
|
|
||
|
Percentage change
|
91
|
%
|
|
|
|||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Cost of goods sold
|
$
|
766
|
|
|
$
|
309
|
|
|
Gross margin
|
92
|
%
|
|
94
|
%
|
||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Research and development expenses
|
$
|
22,282
|
|
|
$
|
54,847
|
|
|
Dollar change
|
$
|
(32,565
|
)
|
|
|
||
|
Percentage change
|
(59
|
)%
|
|
|
|||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Selling, general and administrative expenses
|
$
|
9,531
|
|
|
$
|
14,691
|
|
|
Dollar change
|
$
|
(5,160
|
)
|
|
|
||
|
Percentage change
|
(35
|
)%
|
|
|
|||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Restructuring (recovery) charge
|
$
|
(431
|
)
|
|
$
|
46
|
|
|
Dollar change
|
$
|
(477
|
)
|
|
|
||
|
Percentage change
|
(1,037
|
)%
|
|
|
|||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Interest income and other, net
|
$
|
(7
|
)
|
|
$
|
2,131
|
|
|
Interest expense
|
(12,403
|
)
|
|
(11,762
|
)
|
||
|
Total other expense, net
|
$
|
(12,410
|
)
|
|
$
|
(9,631
|
)
|
|
Dollar change
|
$
|
(2,779
|
)
|
|
|
||
|
Percentage change
|
29
|
%
|
|
|
|||
|
|
Three Months Ended March 31,
|
||||||
|
|
2015
|
|
2014
|
||||
|
Net loss
|
$
|
(35,170
|
)
|
|
$
|
(74,619
|
)
|
|
Net cash used in operating activities
|
(45,086
|
)
|
|
(72,086
|
)
|
||
|
Net cash provided by investing activities
|
49,895
|
|
|
60,360
|
|
||
|
Net cash (used in) provided by financing activities
|
(217
|
)
|
|
65,287
|
|
||
|
Net increase in cash and cash equivalents
|
4,592
|
|
|
53,561
|
|
||
|
Cash and cash equivalents at beginning of period
|
80,395
|
|
|
103,978
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
84,987
|
|
|
$
|
157,539
|
|
|
•
|
the progress and scope of the development and commercialization activities with respect to cabozantinib;
|
|
•
|
the commercial success of COMETRIQ and the revenues we generate;
|
|
•
|
our obligation to share U.S. marketing and commercialization costs for cobimetinib under our collaboration with Genentech;
|
|
•
|
the commercial success of cobimetinib and our share of related profits and losses for the commercialization of cobimetinib in the U.S. and receipt of royalties from cobimetinib sales outside the U.S. under our collaboration with Genentech;
|
|
•
|
repayment of the $104.0 million principal amount outstanding of the Deerfield Notes, which mature on July 1, 2015, unless the expected extension occurs, in which case we will also be required to make a mandatory prepayment in each of 2016, 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 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 $287.5 million aggregate principal amount of the 2019 Notes, which mature on August 15, 2019, unless earlier converted, redeemed or repurchased;
|
|
•
|
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, short- and long-term investments that serve as collateral for bank lines of credit;
|
|
•
|
future clinical trial results;
|
|
•
|
our need to expand our product and clinical development efforts;
|
|
•
|
the cost and timing of regulatory approvals;
|
|
•
|
the cost of clinical and research supplies for our clinical trials;
|
|
•
|
the effect of competing technological and market developments; and
|
|
•
|
the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights.
|
|
•
|
fund our operations and clinical trials;
|
|
•
|
continue our research and development efforts;
|
|
•
|
commercialize cabozantinib or any other future product candidates, if any such candidates receive regulatory approval for commercial sale; and
|
|
•
|
fund the U.S. marketing and commercialization costs for cobimetinib we are obligated to share under our collaboration with Genentech or any similar costs we are obligated to fund under collaborations we may enter into in the future.
|
|
•
|
the progress and scope of the development and commercialization activities with respect to cabozantinib;
|
|
•
|
the commercial success of COMETRIQ and the revenues we generate;
|
|
•
|
our obligation to share U.S. marketing and commercialization costs for cobimetinib under our collaboration with Genentech;
|
|
•
|
the commercial success of cobimetinib and our share of related profits and losses for the commercialization of cobimetinib in the U.S. and receipt of royalties from cobimetinib sales outside the U.S. under our collaboration with Genentech;
|
|
•
|
repayment of the
$104.0 million
principal amount outstanding of the Deerfield Notes, which mature on July 1, 2015, unless the expected extension occurs, in which case we will also be required to make a mandatory prepayment in each of 2016, 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 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
$287.5 million
aggregate principal amount of the 2019 Notes, which mature on
August 15, 2019
, unless earlier converted, redeemed or repurchased;
|
|
•
|
whether we enter into new collaboration agreements, licensing agreements or other arrangements (including, in particular, with respect to cabozantinib outside of the U.S.) that provide additional capital;
|
|
•
|
our ability to control costs;
|
|
•
|
our ability to remain in compliance with, or amend or cause to be waived, financial covenants contained in agreements with third parties;
|
|
•
|
the amount of our cash and cash equivalents, short- and long-term investments that serve as collateral for bank lines of credit;
|
|
•
|
future clinical trial results;
|
|
•
|
our need to expand our product and clinical development efforts;
|
|
•
|
the cost and timing of regulatory approvals;
|
|
•
|
the cost of clinical and research drug supply for our clinical trials;
|
|
•
|
the effect of competing technological and market developments; 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 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 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;
|
|
•
|
preventing us from raising funds necessary to purchase the 2019 Notes in the event we are required to do so following a “Fundamental Change” as specified in the indenture governing the 2019 Notes, or to settle conversions of the 2019 Notes in cash;
|
|
•
|
dilution experienced by our existing stockholders as a result of the conversion of the 2019 Notes or the Deerfield Notes into shares of common stock; and
|
|
•
|
placing us at a possible competitive disadvantage with less leveraged competitors and competitors that may have better access to capital resources.
|
|
•
|
the effectiveness, or perceived effectiveness, of 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 sales, marketing and distribution support; and
|
|
•
|
sufficient third-party coverage and reimbursement.
|
|
•
|
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, 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 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 federal 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).
|
|
•
|
an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs, not including orphan drug sales;
|
|
•
|
an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively;
|
|
•
|
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts on negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
|
•
|
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
|
|
•
|
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals with income at or below 133% of the Federal Poverty Level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
|
|
•
|
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
|
|
•
|
new requirements to report annually under the federal Open Payments program certain financial arrangements with physicians and teaching hospitals, as defined in PPACA and its implementing regulations, including reporting any payment or “transfer of value” provided to physicians and teaching hospitals and any ownership and investment interests held by physicians and their immediate family members during the preceding calendar year;
|
|
•
|
expansion of healthcare fraud and abuse laws, including the federal False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance; and
|
|
•
|
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research.
|
|
•
|
RCC: Pfizer’s axitinib, sunitinib and temsirolimus; Novartis’ everolimus and pazopanib; Bayer’s and Onyx Pharmaceuticals’ sorafenib; Genentech’s bevacizumab; Eisai’s lenvatinib; and Bristol-Myers Squibb’s nivolumab; and
|
|
•
|
HCC: Bayer’s and Onyx Pharmaceuticals’ sorafenib; Bayer’s regorafenib; ArQule’s tivantinib; and Eisai’s lenvatinib.
|
|
•
|
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.
|
|
•
|
we may not be able to control the amount of U.S. marketing and commercialization costs for cobimetinib we are obligated to share under our collaboration with Genentech;
|
|
•
|
we are not able to control the amount and timing of resources that our collaborators or potential future collaborators will devote to the development or commercialization of drug candidates or to their marketing and distribution;
|
|
•
|
collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing;
|
|
•
|
disputes may arise between us and our collaborators that result in the delay or termination of the research, development or commercialization of our drug candidates or that result in costly litigation or arbitration that diverts management’s attention and resources;
|
|
•
|
collaborators may experience financial difficulties;
|
|
•
|
collaborators may not be successful in their efforts to obtain regulatory approvals in a timely manner, or at all;
|
|
•
|
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation;
|
|
•
|
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 progress and scope of our development and commercialization activities;
|
|
•
|
the commercial success of COMETRIQ and the revenues we generate;
|
|
•
|
recognition of upfront licensing or other fees or revenues;
|
|
•
|
payments of non-refundable upfront or licensing fees, or payment for cost-sharing expenses, to third parties;
|
|
•
|
acceptance of our technologies and platforms;
|
|
•
|
the success rate of our efforts leading to milestone payments and royalties;
|
|
•
|
the introduction of new technologies or products by our competitors;
|
|
•
|
the timing and willingness of collaborators to further develop or, if approved, commercialize our product candidates 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 restructuring activities; 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 commercial success of COMETRIQ and the revenues we generate;
|
|
•
|
the timing of achievement of our clinical, regulatory, partnering and other milestones, such as the commencement of clinical development, the completion of a clinical trial, the filing for regulatory approval or the establishment of collaborative arrangements for 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;
|
|
•
|
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;
|
|
•
|
developments concerning current or future collaborations;
|
|
•
|
FDA or international regulatory actions;
|
|
•
|
third-party coverage and 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.
|
|
|
|
|
EXELIXIS, INC.
|
|
|
|
|
|
|
|
|
|
April 30, 2015
|
|
/s/ D
EBORAH
B
URKE
|
|
|
|
Date
|
|
Deborah Burke
|
|
|
|
|
|
Senior 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
|
|
|
|
3.4
|
|
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
|
|
4/7/2000
|
|
|
|
4.2
|
|
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
|
|
|
|
4.3
|
|
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
|
|
|
|
4.4
|
|
Form of Amended and Restated Secured Convertible Note issuable to entities affiliated with Deerfield Management Company, L.P.
|
|
8-K
|
|
000-30235
|
|
10.1 (Exhibit A)
|
|
1/22/2014
|
|
|
|
4.5
|
|
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
|
|
|
|
4.6
|
|
Form of Warrant to Purchase Common Stock of Exelixis, Inc. issued to Deerfield Partners, L.P. and Deerfield International Master Fund, L.P.
|
|
8-K
|
|
000-30235
|
|
4.1
|
|
1/22/2014
|
|
|
|
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
|
|
Compensation Information for Named Executive Officers
|
|
8-K
|
|
000-30235
|
|
5.02 Disclosure
|
|
2/11/2015
|
|
|
|
10.2
|
|
Compensation Information for Non-Employee Directors
|
|
8-K
|
|
000-30235
|
|
10.2
|
|
10/16/2014
|
|
|
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporation by Reference
|
|
Filed
Herewith
|
||||||
|
Form
|
|
File Number
|
|
Exhibit/
Appendix
Reference
|
|
Filing Date
|
|
|||||
|
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
|
|
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
|
|
‡
|
This certification accompanies this Quarterly Report on Form 10-Q, is not deemed filed with the SEC and is not to be incorporated by reference into any filing of Exelixis, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Quarterly Report on Form 10-Q), irrespective of any general incorporation language contained in such filing.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|