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| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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Delaware
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52-2154066
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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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2910 Seventh Street, Berkeley,
California 94710
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(510) 204-7200
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(Address of principal executive offices, including zip code)
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(Telephone Number)
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Large accelerated filer
o
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Accelerated filer
x
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Non-accelerated filer
o
(Do not check if a smaller reporting company)
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Smaller reporting company
o
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Class
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Outstanding at August 5, 2014
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Common Stock, $0.0075 par value
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107,077,178
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Page
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PART I FINANCIAL INFORMATION
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|
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Condensed Consolidated Financial Statements (unaudited)
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1
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2
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3
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4
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Item 2.
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14
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Item 3.
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21
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Item 4.
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22
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PART II OTHER INFORMATION
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Item 1.
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22
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|
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Item 1A.
|
22
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Item 2.
|
40
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Item 3.
|
40
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Item 4.
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40
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Item 5.
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40
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Item 6.
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40
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41
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||
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June 30,
2014
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December 31, 2013
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||||||
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(unaudited)
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(Note 1)
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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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65,895
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$
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101,659
|
|||||
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Short-term investments
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9,998
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19,990
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||||||
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Trade and other receivables, net
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5,510
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3,781
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||||||
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Prepaid expenses and other current assets
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2,129
|
1,630
|
||||||
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Total current assets
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83,532
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127,060
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||||||
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Property and equipment, net
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5,595
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6,456
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||||||
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Other assets
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798
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1,266
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||||||
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Total assets
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$
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89,925
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$
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134,782
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||||
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||||||||
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LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
||||||||
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Current liabilities:
|
||||||||
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Accounts payable
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$
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7,857
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$
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9,616
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||||
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Accrued and other liabilities
|
6,389
|
9,934
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||||||
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Deferred revenue
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2,139
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2,218
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||||||
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Interest bearing obligation – current
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20,970
|
5,835
|
||||||
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Accrued Interest on interest bearing obligations – current
|
299
|
2,042
|
||||||
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Total current liabilities
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37,654
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29,645
|
||||||
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Deferred revenue – long-term
|
3,134
|
4,105
|
||||||
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Interest bearing obligations – long-term
|
17,330
|
35,150
|
||||||
|
Contingent warrant liabilities
|
39,379
|
69,869
|
||||||
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Total liabilities
|
97,497
|
138,769
|
||||||
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|
||||||||
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Stockholders’ deficit:
|
||||||||
|
Common stock, $0.0075 par value, 277,333,332 shares authorized, 107,020,607 and 105,386,216 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively
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800
|
787
|
||||||
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Additional paid-in capital
|
1,089,382
|
1,076,403
|
||||||
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Accumulated comprehensive income (loss)
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6
|
(1
|
)
|
|||||
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Accumulated deficit
|
(1,097,760
|
)
|
(1,081,176
|
)
|
||||
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Total stockholders’ deficit
|
(7,572
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)
|
(3,987
|
)
|
||||
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Total liabilities and stockholders’ deficit
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$
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89,925
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$
|
134,782
|
||||
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Three months ended June 30,
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Six months ended June 30,
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||||||||||||||
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2014
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2013
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2014
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2013
|
||||||||||||
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Revenues:
|
|
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|
||||||||||||
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License and collaborative fees
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$
|
1,201
|
$
|
605
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$
|
2,164
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$
|
1,003
|
||||||||
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Contract and other
|
4,772
|
6,546
|
7,219
|
15,602
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||||||||||||
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Total revenues
|
5,973
|
7,151
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9,383
|
16,605
|
||||||||||||
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||||||||||||||||
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Operating expenses:
|
||||||||||||||||
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Research and development
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19,590
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17,070
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41,136
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33,707
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||||||||||||
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Selling, general and administrative
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5,160
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4,081
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10,414
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8,203
|
||||||||||||
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Restructuring
|
-
|
79
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84
|
97
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||||||||||||
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Total operating expenses
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24,750
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21,230
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51,634
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42,007
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||||||||||||
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||||||||||||||||
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Loss from operations
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(18,777
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)
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(14,079
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)
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(42,251
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)
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(25,402
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)
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||||||||
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||||||||||||||||
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Other (expense) income, net:
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||||||||||||||||
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Interest expense
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(1,110
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)
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(1,164
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)
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(2,236
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)
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(2,336
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)
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||||||||
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Other income (expense), net
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27
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(224
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)
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(61
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)
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224
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||||||||||
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Revaluation of contingent warrant liabilities
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7,963
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(1,781
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)
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27,964
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(14,621
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)
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||||||||||
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Net loss
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$
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(11,897
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)
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$
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(17,248
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)
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$
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(16,584
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)
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$
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(42,135
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)
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||||
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||||||||||||||||
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Basic net loss per share of common stock
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$
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(0.11
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)
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$
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(0.21
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)
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$
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(0.16
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)
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$
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(0.51
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)
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||||
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Diluted net loss per share of common stock
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$
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(0.17
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)
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$
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(0.21
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)
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$
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(0.38
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)
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$
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(0.51
|
)
|
||||
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|
||||||||||||||||
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Shares used in computing basic net loss per share of common stock
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106,927
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82,939
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106,545
|
82,768
|
||||||||||||
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Shares used in computing diluted net loss per share of common stock
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114,126
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82,939
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115,048
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82,768
|
||||||||||||
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|
||||||||||||||||
|
Other comprehensive loss:
|
||||||||||||||||
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Net loss
|
$
|
(11,897
|
)
|
$
|
(17,248
|
)
|
$
|
(16,584
|
)
|
$
|
(42,135
|
)
|
||||
|
Net unrealized (loss) gain on available-for-sale securities
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(1
|
)
|
(11
|
)
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7
|
(8
|
)
|
|||||||||
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Comprehensive loss
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$
|
(11,898
|
)
|
$
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(17,259
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)
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$
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(16,577
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)
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$
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(42,143
|
)
|
||||
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|
Six Months Ended June 30,
|
|||||||
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|
2014
|
2013
|
||||||
|
Cash flows from operating activities:
|
|
|
||||||
|
$
|
(16,584
|
)
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$
|
(42,135
|
)
|
|||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
|
Depreciation
|
941
|
1,413
|
||||||
|
Common stock contribution to 401(k)
|
870
|
828
|
||||||
|
Stock-based compensation expense
|
6,348
|
2,719
|
||||||
|
Accrued interest on interest bearing obligations
|
(1,570
|
)
|
1,757
|
|||||
|
Revaluation of contingent warrant liabilities
|
(27,964
|
)
|
14,621
|
|||||
|
Amortization of debt discount, final payment fee on debt, and debt issuance costs
|
1,362
|
1,214
|
||||||
|
Loss on sale costs and retirement of property and equipment
|
-
|
281
|
||||||
|
Unrealized gain on foreign currency exchange
|
(241
|
)
|
(265
|
)
|
||||
|
Unrealized loss on foreign exchange options
|
239
|
192
|
||||||
|
Other non-cash adjustments
|
(2
|
)
|
12
|
|||||
|
Changes in assets and liabilities:
|
||||||||
|
Trade and other receivables, net
|
(1,728
|
)
|
974
|
|||||
|
Prepaid expenses and other assets
|
(491
|
)
|
(880
|
)
|
||||
|
Accounts payable and accrued liabilities
|
(5,179
|
)
|
(4,128
|
)
|
||||
|
Deferred revenue
|
(1,019
|
)
|
(713
|
)
|
||||
|
Other liabilities
|
(81
|
)
|
(1,662
|
)
|
||||
|
Net cash used in operating activities
|
(45,099
|
)
|
(25,772
|
)
|
||||
|
|
||||||||
|
Cash flows from investing activities:
|
||||||||
|
Proceeds from maturities of investments
|
10,000
|
40,000
|
||||||
|
Net purchase of property and equipment
|
(80
|
)
|
(859
|
)
|
||||
|
Net cash provided by investing activities
|
9,920
|
39,141
|
||||||
|
|
||||||||
|
Cash flows from financing activities:
|
||||||||
|
Proceeds from issuance of common stock, net of issuance costs
|
3,213
|
262
|
||||||
|
Proceeds from exercise of warrants
|
35
|
-
|
||||||
|
Principal payments of debt
|
(3,833
|
)
|
(1,042
|
)
|
||||
|
Net cash used in financing activities
|
(585
|
)
|
(780
|
)
|
||||
|
|
||||||||
|
Net (decrease) increase in cash and cash equivalents
|
(35,764
|
)
|
12,589
|
|||||
|
Cash and cash equivalents at the beginning of the period
|
101,659
|
45,345
|
||||||
|
Cash and cash equivalents at the end of the period
|
$
|
65,895
|
$
|
57,934
|
||||
|
|
||||||||
|
Supplemental Cash Flow Information:
|
||||||||
|
Cash paid for:
|
||||||||
|
Interest
|
$
|
2,413
|
$
|
679
|
||||
|
Non-cash investing and financing activities:
|
||||||||
|
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
$
|
(2,526
|
)
|
$
|
(4
|
)
|
||
|
Interest added to principal balances on long-term debt
|
$
|
157
|
$
|
479
|
||||
|
1.
|
Description of Business
|
|
2.
|
Basis of Presentation and Significant Accounting Policies
|
|
3.
|
Condensed Consolidated Financial Statement Detail
|
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
|
2014
|
2013
|
2014
|
2013
|
||||||||||||
|
Common stock options and restricted stock units
|
7,939
|
7,346
|
6,576
|
7,084
|
||||||||||||
|
Warrants for common stock
|
1,910
|
16,176
|
1,910
|
16,176
|
||||||||||||
|
Total
|
9,849
|
23,522
|
8,486
|
23,260
|
||||||||||||
|
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
||||||
|
|
2014
|
2014
|
||||||
|
Numerator
|
|
|
||||||
|
Net loss
|
|
|
||||||
|
Basic
|
$
|
(11,897
|
)
|
$
|
(16,584
|
)
|
||
|
Adjustment for revaluation of contingent warrant liabilities
|
(7,616
|
)
|
(27,150
|
)
|
||||
|
Diluted
|
$
|
(19,513
|
)
|
$
|
(43,734
|
)
|
||
|
Denominator
|
||||||||
|
Weighted average shares outstanding used for basic net loss per share
|
106,927
|
106,545
|
||||||
|
Effect of dilutive warrants
|
7,199
|
8,503
|
||||||
|
Weighted average shares outstanding and dilutive securities used for diluted net income per share
|
114,126
|
115,048
|
||||||
|
|
June 30,
2014 |
December 31,
2013 |
||||||
|
Accrued payroll and other benefits
|
$
|
2,698
|
$
|
3,009
|
||||
|
Accrued management incentive compensation
|
2,123
|
4,386
|
||||||
|
Other
|
1,568
|
2,539
|
||||||
|
Total
|
$
|
6,389
|
$
|
9,934
|
||||
|
4.
|
Fair Value Measurements
|
|
|
Fair Value Measurements at June 30, 2014 Using
|
|
||||||||||||||
|
|
Quoted Prices in Active Markets for Identical Assets
|
Significant Other Observable Inputs
|
Significant Unobservable Inputs
|
|
||||||||||||
|
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
Total
|
||||||||||||
|
Assets:
|
|
|
|
|
||||||||||||
|
Money market funds
(1)
|
$
|
49,563
|
$
|
-
|
$
|
-
|
$
|
49,563
|
||||||||
|
U.S. treasury securities
|
9,998
|
-
|
-
|
9,998
|
||||||||||||
|
Foreign exchange options
|
-
|
122
|
-
|
122
|
||||||||||||
|
Total
|
$
|
59,561
|
$
|
122
|
$
|
-
|
$
|
59,683
|
||||||||
|
|
||||||||||||||||
|
Liabilities:
|
||||||||||||||||
|
Contingent warrant liabilities
|
$
|
-
|
$
|
-
|
$
|
39,379
|
$
|
39,379
|
||||||||
|
|
||||||||||||||||
|
|
Fair Value Measurements at December 31, 2013 Using
|
|||||||||||||||
|
|
Quoted Prices in Active Markets for Identical Assets
|
Significant Other Observable Inputs
|
Significant Unobservable Inputs
|
|||||||||||||
|
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
Total
|
||||||||||||
|
Assets:
|
||||||||||||||||
|
Money market funds
(1)
|
$
|
82,759
|
$
|
-
|
$
|
-
|
$
|
82,759
|
||||||||
|
U.S. treasury securities
|
19,990
|
-
|
-
|
19,990
|
||||||||||||
|
Foreign exchange options
|
-
|
361
|
-
|
361
|
||||||||||||
|
Total
|
$
|
102,749
|
$
|
361
|
$
|
-
|
$
|
103,110
|
||||||||
|
|
||||||||||||||||
|
Liabilities:
|
||||||||||||||||
|
Contingent warrant liabilities
|
$
|
-
|
$
|
-
|
$
|
69,869
|
$
|
69,869
|
||||||||
|
|
June 30,
2014 |
December 31,
2013 |
||||||
|
Expected volatility
|
72.9% - 92.8
|
%
|
66.1% - 86.6
|
%
|
||||
|
Risk-free interest rate
|
0.1% - 0.9
|
%
|
0.1% - 0.8
|
%
|
||||
|
Expected term
|
0.4 - 2.7 years
|
0.9 - 3.2 years
|
||||||
|
Contingent warrant liabilities
|
June 30,
2014 |
|||
|
Balance at December 31, 2013
|
$
|
69,869
|
||
|
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
(2,526
|
)
|
||
|
Net decrease in fair value of contingent warrant liabilities upon revaluation
|
(27,964
|
)
|
||
|
Balance at June 30, 2014
|
$
|
39,379
|
||
|
5.
|
Long-Term Debt and Other Financings
|
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
|
2014
|
2013
|
2014
|
2013
|
||||||||||||
|
Interest expense
|
|
|
|
|
||||||||||||
|
Servier loan
|
$
|
600
|
$
|
528
|
$
|
1,188
|
$
|
1,053
|
||||||||
|
GECC term loan
|
423
|
531
|
870
|
1,077
|
||||||||||||
|
Novartis note
|
78
|
91
|
155
|
182
|
||||||||||||
|
Other
|
9
|
14
|
23
|
24
|
||||||||||||
|
Total interest expense
|
$
|
1,110
|
$
|
1,164
|
$
|
2,236
|
$
|
2,336
|
||||||||
|
6.
|
Income Taxes
|
|
7.
|
Stock-based Compensation
|
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
|
2014
|
2013
|
2014
|
2013
|
||||||||||||
|
Dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||||
|
Expected volatility
|
91
|
%
|
92
|
%
|
93
|
%
|
92
|
%
|
||||||||
|
Risk-free interest rate
|
1.68
|
%
|
1.44
|
%
|
1.71
|
%
|
0.84
|
%
|
||||||||
|
Expected term
|
5.6 years
|
5.6 years
|
5.6 years
|
5.6 years
|
||||||||||||
|
|
Options
|
Weighted Average Exercise Price Per Share
|
Weighted Average Remaining Contractual Life (in years)
|
Aggregate Intrinsic Value (in thousands)
|
||||||||||||
|
Options outstanding at December 31, 2013
|
7,218,241
|
$
|
8.42
|
6.75
|
$
|
18,213
|
||||||||||
|
Granted
|
1,621,089
|
7.11
|
||||||||||||||
|
Exercised
|
(736,896
|
)
|
4.32
|
|||||||||||||
|
Forfeited, expired or cancelled
|
(286,255
|
)
|
19.11
|
|||||||||||||
|
Options outstanding at June 30, 2014
|
7,816,179
|
$
|
8.14
|
7.00
|
$
|
7,382
|
||||||||||
|
Options exercisable at June 30, 2014
|
4,684,553
|
$
|
10.34
|
5.72
|
$
|
4,278
|
||||||||||
|
|
Number of
Shares
|
Weighted-
Average Grant-
|
||||||
|
Unvested balance at December 31, 2013
|
1,738,037
|
$
|
2.73
|
|||||
|
Granted
|
1,299,164
|
6.47
|
||||||
|
Vested
|
(514,125
|
)
|
4.11
|
|||||
|
Forfeited
|
(158,286
|
)
|
3.87
|
|||||
|
Unvested balance at June 30, 2014
|
2,364,790
|
$
|
4.97
|
|||||
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
|
2014
|
2013
|
2014
|
2013
|
||||||||||||
|
Research and development
|
$
|
953
|
$
|
432
|
$
|
3,359
|
$
|
1,429
|
||||||||
|
Selling, general and administrative
|
1,471
|
667
|
2,989
|
1,290
|
||||||||||||
|
Total stock-based compensation expense
|
$
|
2,424
|
$
|
1,099
|
$
|
6,348
|
$
|
2,719
|
||||||||
| · | On February 24, 2014, we announced that gevokizumab has been granted Orphan Drug Designation by the FDA for the treatment of PG. |
| · | On March 4, 2014, we reported that despite early positive results in the first of two Phase 2 programs in patients with EOA, the top-line data at Day 168 in that study, as well as data at Day 84 in the second study, were not positive. These results led to our decision not to pursue Phase 3 testing in the broad EOA population. We will continue to review the data to determine if there is a subgroup of the EOA population that could benefit from gevokizumab therapy . |
| · | In the second quarter of 2014, we finalized our plans for our gevokizumab Phase 3 program in PG, and submitted the protocols to the FDA for any further comments. The Phase 3 program is expected to include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll approximately 60 patients with active PG. The primary endpoint is complete wound closure of the target ulcer at approximately Day 124. |
| · | On January 7, 2014, we announced that we and Patrick J. Scannon, M.D., Ph.D, our Executive Vice President and Chief Scientific Officer, amended Dr. Scannon’s employment arrangement with XOMA to reflect a change in Dr. Scannon’s status from full- to part-time service, reducing his annual base salary to $250,000, effective retroactively to January 1, 2014. Dr. Scannon will continue his service as a member of our Board of Directors and will remain our Chief Scientific Officer and an Executive Vice President. |
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||||||||||
|
|
2014
|
2013
|
Increase (Decrease)
|
2014
|
2013
|
Increase (Decrease)
|
||||||||||||||||||
|
License and collaborative fees
|
$
|
1,201
|
$
|
605
|
$
|
596
|
$
|
2,164
|
$
|
1,003
|
$
|
1,161
|
||||||||||||
|
Contract and other
|
4,772
|
6,546
|
(1,774
|
)
|
7,219
|
15,602
|
(8,383
|
)
|
||||||||||||||||
|
Total revenues
|
$
|
5,973
|
$
|
7,151
|
$
|
(1,178
|
)
|
$
|
9,383
|
$
|
16,605
|
$
|
(7,222
|
)
|
||||||||||
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||||||||||
|
|
2014
|
2013
|
Increase (Decrease)
|
2014
|
2013
|
Increase (Decrease)
|
||||||||||||||||||
|
NIAID
|
$
|
3,580
|
$
|
2,460
|
$
|
1,120
|
$
|
5,176
|
$
|
4,156
|
$
|
1,020
|
||||||||||||
|
Servier
|
1,076
|
3,456
|
(2,380
|
)
|
1,959
|
10,483
|
(8,524
|
)
|
||||||||||||||||
|
Other
|
116
|
630
|
(514
|
)
|
84
|
963
|
(879
|
)
|
||||||||||||||||
|
Total contract and other
|
$
|
4,772
|
$
|
6,546
|
$
|
(1,774
|
)
|
$
|
7,219
|
$
|
15,602
|
$
|
(8,383
|
)
|
||||||||||
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
|
2014
|
2013
|
2014
|
2013
|
||||||||||||
|
Earlier stage programs
|
$
|
9,521
|
$
|
8,866
|
$
|
20,448
|
$
|
18,083
|
||||||||
|
Later stage programs
|
10,069
|
8,204
|
20,688
|
15,624
|
||||||||||||
|
Total
|
$
|
19,590
|
$
|
17,070
|
$
|
41,136
|
$
|
33,707
|
||||||||
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
|
2014
|
2013
|
2014
|
2013
|
||||||||||||
|
Internal projects
|
$
|
11,104
|
$
|
10,113
|
$
|
26,073
|
$
|
19,938
|
||||||||
|
Collaborative and contract arrangements
|
8,486
|
6,957
|
15,063
|
13,769
|
||||||||||||
|
Total
|
$
|
19,590
|
$
|
17,070
|
$
|
41,136
|
$
|
33,707
|
||||||||
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||||||||||
|
|
2014
|
2013
|
Increase (Decrease)
|
2014
|
2013
|
Increase (Decrease)
|
||||||||||||||||||
|
Interest expense
|
|
|
|
|
|
|
||||||||||||||||||
|
Servier loan
|
$
|
600
|
$
|
528
|
$
|
72
|
$
|
1,188
|
$
|
1,053
|
$
|
135
|
||||||||||||
|
GECC term loan
|
423
|
531
|
(108
|
)
|
870
|
1,077
|
(207
|
)
|
||||||||||||||||
|
Novartis note
|
78
|
91
|
(13
|
)
|
155
|
182
|
(27
|
)
|
||||||||||||||||
|
Other
|
9
|
14
|
(5
|
)
|
23
|
24
|
(1
|
)
|
||||||||||||||||
|
Total interest expense
|
$
|
1,110
|
$
|
1,164
|
$
|
(54
|
)
|
$
|
2,236
|
$
|
2,336
|
$
|
(100
|
)
|
||||||||||
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||||||||||
|
|
2014
|
2013
|
Increase (Decrease)
|
2014
|
2013
|
Increase (Decrease)
|
||||||||||||||||||
|
Other income (expense), net
|
|
|
|
|
|
|
||||||||||||||||||
|
Unrealized foreign exchange gain (loss)
(1)
|
$
|
175
|
$
|
(251
|
)
|
$
|
426
|
$
|
241
|
$
|
265
|
$
|
(24
|
)
|
||||||||||
|
Unrealized loss on foreign exchange options
|
(116
|
)
|
(2
|
)
|
(114
|
)
|
(239
|
)
|
(192
|
)
|
(47
|
)
|
||||||||||||
|
Other
|
(32
|
)
|
29
|
(61
|
)
|
(63
|
)
|
151
|
(215
|
)
|
||||||||||||||
|
Total other income (expense)
|
$
|
27
|
$
|
(224
|
)
|
$
|
251
|
$
|
(61
|
)
|
$
|
224
|
$
|
(286
|
)
|
|||||||||
|
(1)
|
Unrealized foreign exchange gain (loss) for the three and six months ended June 30, 2014 and 2013 primarily relates to the re-measurement of the €15 million Servier loan.
|
|
Contingent warrant liabilities
|
June 30,
2014 |
|||
|
Balance at December 31, 2013
|
$
|
69,869
|
||
|
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
(2,526
|
)
|
||
|
Net decrease in fair value of contingent warrant liabilities upon revaluation
|
(27,964
|
)
|
||
|
Balance at June 30, 2014
|
$
|
39,379
|
||
|
|
June 30, 2014
|
December 31, 2013
|
Change
|
|||||||||
|
Cash and cash equivalents
|
$
|
65,895
|
$
|
101,659
|
$
|
(35,764
|
)
|
|||||
|
Short-term investments
|
$
|
9,998
|
$
|
19,990
|
$
|
(9,992
|
)
|
|||||
|
Working Capital
|
$
|
45,878
|
$
|
97,415
|
$
|
(51,537
|
)
|
|||||
|
|
||||||||||||
|
|
Six Months Ended June 30,
|
|||||||||||
|
|
2014 | 2013 |
Change
|
|||||||||
|
|
||||||||||||
|
Net cash used in operating activities
|
$
|
(45,099
|
)
|
$
|
(25,772
|
)
|
$
|
(19,327
|
)
|
|||
|
Net cash provided by investing activities
|
9,920
|
39,141
|
(29,221
|
)
|
||||||||
|
Net cash used in financing activities
|
(585
|
)
|
(780
|
)
|
195
|
|||||||
|
Net increase in cash and cash equivalents
|
$
|
(35,764
|
)
|
$
|
12,589
|
$
|
(48,353
|
)
|
||||
|
·
|
terminate or delay clinical trials for one or more of our product candidates;
|
|
·
|
further reduce our headcount and capital or operating expenditures; or
|
|
·
|
curtail our spending on protecting our intellectual property.
|
|
·
|
operations will generate meaningful funds;
|
|
·
|
additional agreements for product development funding can be reached;
|
|
·
|
strategic alliances can be negotiated; or
|
|
·
|
adequate additional financing will be available for us to finance our own development on acceptable terms, or at all.
|
| · | In December 2010, we entered into a license and collaboration agreement with Servier, to jointly develop and commercialize gevokizumab in multiple indications. Under the terms of the agreement, Servier has worldwide rights to cardiovascular disease and diabetes indications and rights outside the United States and Japan to all other indications, including Behçet’s uveitis and other inflammatory and oncology indications. In late 2011, we announced Servier agreed to include the NIU Phase 3 trials under the terms of the collaboration agreement for Behçet’s uveitis. We retain development and commercialization rights for NIU and other inflammatory disease and oncology indications in the United States and Japan and have an option to reacquire rights to cardiovascular disease and diabetes indications from Servier in these territories. Should we exercise this option, we will be required to pay an option fee to Servier and partially reimburse a specified portion of Servier’s incurred development expenses. The agreement contains mutual customary termination rights relating to matters such as material breach by either party. Servier may terminate for safety issues, and we may terminate the agreement, with respect to a particular country or the European Patent Organization (“EPO”) member states, for any challenge to our patent rights in that country or any EPO member state, respectively, by Servier. Servier also has a unilateral right to terminate the agreement for the European Union (“EU”) or for non-EU countries, on a country-by-country basis, or in its entirety, in each case with six months’ notice. |
| · | In December 2010, we entered into a loan agreement with Servier (the “Servier Loan Agreement”), which provides for an advance of up to €15.0 million and was funded fully in January 2011 with the proceeds converting to approximately $19.5 million at the January 13, 2011, Euro-to-U.S.-dollar exchange rate of 1.3020. This loan is secured by an interest in our intellectual property rights to all gevokizumab indications worldwide, excluding the United States and Japan. The loan has a final maturity date in 2016; however, after a specified period prior to final maturity, the loan is required to be repaid (1) at Servier’s option, by applying up to a significant percentage of any milestone or royalty payments owed by Servier under our collaboration agreement and (2) using a significant percentage of any upfront, milestone or royalty payments we receive from any third-party collaboration or development partner for rights to gevokizumab in the United States and/or Japan. In addition, the loan becomes immediately due and payable upon certain customary events of default. At June 30, 2014, the €15.0 million outstanding principal balance under this Servier Loan Agreement would have equaled approximately $20.5 million using the June 30, 2014 Euro-to-U.S.-dollar exchange rate of 1.3645. |
| · | clinical development and testing; |
| · | manufacturing; |
| · | labeling; |
| · | storage; |
| · | record keeping; |
| · | promotion and marketing; and |
| · | importing and exporting. |
| · | our future filings will be delayed; |
| · | our preclinical and clinical studies will be successful; |
| · | we will be successful in generating viable product candidates to targets; |
| · | we will be able to provide necessary additional data; |
| · | results of future clinical trials will justify further development; or |
| · | we ultimately will achieve regulatory approval for any of these product candidates. |
| · | results of preclinical studies and clinical trials; |
| · | information relating to the safety or efficacy of products or product candidates; |
| · | developments regarding regulatory filings; |
| · | announcements of new collaborations; |
| · | failure to enter into collaborations; |
| · | developments in existing collaborations; |
| · | our funding requirements and the terms of our financing arrangements; |
| · | technological innovations or new indications for our therapeutic products and product candidates; |
| · | introduction of new products or technologies by us or our competitors; |
| · | sales and estimated or forecasted sales of products for which we receive royalties, if any; |
| · | government regulations; |
| · | developments in patent or other proprietary rights; |
| · | the number of shares issued and outstanding; |
| · | the number of shares trading on an average trading day; |
| · | announcements regarding other participants in the biotechnology and pharmaceutical industries; and |
| · | market speculation regarding any of the foregoing. |
| · | In March 2004, we announced we had agreed to collaborate with Chiron Corporation (now Novartis) for the development and commercialization of antibody products for the treatment of cancer. In April 2005, we announced the initiation of clinical testing of the first product candidate out of the collaboration, HCD122, an anti-CD40 antibody, in patients with advanced chronic lymphocytic leukemia. In October 2005, we announced the initiation of the second clinical trial of HCD122 in patients with multiple myeloma. In November 2008, we announced the restructuring of this product development collaboration, which involved six development programs. In exchange for cash and debt reduction on our existing loan facility with Novartis, Novartis has control over the programs, as well as the right to expand the development of these programs into additional indications outside of oncology. Clinical development of at least one of the product candidates is ongoing at Novartis. |
| · | In March 2005, we entered into a contract with the National Institute of Allergy and Infectious Diseases (“NIAID”) to produce three monoclonal antibodies designed to protect U.S. citizens against the harmful effects of botulinum neurotoxin used in bioterrorism. In July 2006, we entered into an additional contract with NIAID for the development of an appropriate formulation for human administration of these three antibodies in a single injection. In September 2008, we announced we had been awarded an additional contract with NIAID to support our on-going development of drug candidates toward clinical trials in the treatment of botulism poisoning. In October 2011, we announced we had been awarded an additional contract with NIAID to develop broad-spectrum antitoxins for the treatment of human botulism poisoning. |
| · | We have licensed our bacterial cell expression technology, an enabling technology used to discover and screen, as well as develop and manufacture, recombinant antibodies and other proteins for commercial purposes, to over 60 companies. As of August 5, 2014, we were aware of two antibody products manufactured using this technology that have received FDA approval, Genentech’s LUCENTIS ® (ranibizumab injection) for treatment of neovascular wet age-related macular degeneration and UCB’s CIMZIA ® (certolizumab pegol) for treatment of Crohn’s disease and rheumatoid arthritis. In the third quarter of 2009, we sold our LUCENTIS royalty interest to Genentech. In the third quarter of 2010, we sold our CIMZIA royalty interest. |
| · | On July 24, 2012, Servier and we entered into an agreement with Boehringer Ingelheim to transfer XOMA's technology and processes for the manufacture of gevokizumab to Boehringer lngelheim for Boehringer Ingelheim's implementation and validation in preparation for the commercial manufacture of gevokizumab. Upon the successful completion of the transfer and the establishment of biological comparability, including validation of the XOMA processes as implemented by Boehringer Ingelheim, we intend Boehringer Ingelheim will produce gevokizumab for XOMA's commercial use at its facility in Biberach, Germany. Servier and we retain all rights to the development and commercialization of gevokizumab. Transferring of our technology to Boehringer Ingelheim exposes us to numerous risks, including the possibility that Boehringer Ingelheim may not perform under the agreement as anticipated, and that we will need to successfully conduct a comparability trial demonstrating to the FDA’s satisfaction the similarity between XOMA-manufactured and Boehringer Ingelheim-manufactured product. |
| · | significantly greater financial resources; |
| · | larger research and development and marketing staffs; |
| · | larger production facilities; |
| · | entered into arrangements with, or acquired, biotechnology companies to enhance their capabilities; or |
| · | extensive experience in preclinical testing and human clinical trials. |
| · | Novartis markets and is developing ILARIS® (canakinumab, ACZ885), a fully human monoclonal antibody that selectively binds to and neutralizes IL-1 beta. Since 2009, canakinumab has been approved in over 50 countries for the treatment of children and adults suffering from Cryopyrin-Associated Periodic Syndrome (“CAPS”). The product is indicated in the US for the treatment of CAPS in patients over four years of age, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), as well as for active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older. In the EU, canakinumab is indicated for the treatment of FCAS, MWS, neonatal-onset multisystem inflammatory disease (NOMID)/ chronic infantile neurological cutaneous articular syndrome (CINCA syndrome), severe forms of FCAS/familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticaria skin rash, for the symptomatic treatment of adults with frequent gouty arthritis attacks, and for SJIA in patients aged two years and above who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs and systemic corticosteroids. In Japan, canakinumab is indicated for the treatment of CAPS and associated autoinflammatory symptoms, including FCAS, MWS and NOMID. Novartis also is pursuing other diseases in which IL-1 beta may play a prominent role, such as: systemic secondary prevention of cardiovascular events; hereditary periodic fever (familial Mediterranean fever (FMF)); chronic obstructive pulmonary disorder (COPD); osteoarthritis; urticarial vasculitis; TNF-receptor associated periodic syndrome (TRAPS); xerophthalmia; Schnitzler syndrome; polymyalgia rheumatica; hyperimmunoglobulinemia D (hyper-IgD) and periodic fever syndrome (HIDS); and abdominal aortic aneurysm (AAA). |
| · | In 2008, Swedish Orphan Biovitrum obtained from Amgen the global exclusive rights to Kineret ® (anakinra) for rheumatoid arthritis as currently indicated in its label. In November 2009, the agreement regarding Swedish Orphan Biovitrum’s Kineret license was expanded to include certain orphan indications. Kineret is an IL-1 receptor antagonist (IL-1ra) that has been evaluated in multiple IL-1-mediated diseases, including indications we are considering for gevokizumab. In addition to other on-going studies, a proof-of-concept clinical trial in the United Kingdom investigating Kineret in patients with a certain type of myocardial infarction, or heart attack, has been completed. In August 2010, Biovitrum announced the FDA had granted orphan drug designation to Kineret for the treatment of CAPS, and in January 2013 they obtained FDA approval for NOMID, a severe form of CAPS. In November 2013, Kineret was approved by the European Commission for the treatment of CAPS. Shanghai CP Guojian Pharmaceutical is developing an injectable formulation of recombinant human IL-1Ra, presumed to be a follow-on biologic version of anakinra, for the potential treatment of rheumatoid arthritis. In February 2010, an NDA was filed with the SFDA; in January 2012, supplemental materials were required by the SFDA to conclude the review. |
| · | AbbVie is developing ABT-981, a dual variable domain immunoglobulin (DVD-Ig) that incorporates anti-IL-1 alpha and anti-IL-1 beta antibodies, for the potential treatment of osteoarthritis. In October 2013, a phase I trial completed. In January 2014, the company expected to start phase II development later that year. |
| · | Amgen was developing AMG 108, a fully human monoclonal antibody that targets inhibition of the action of IL-1. In April 2008, Amgen reported results from a Phase 2 study in rheumatoid arthritis. AMG 108 showed statistically significant improvement in the signs and symptoms of rheumatoid arthritis and was well tolerated. In January 2011, MedImmune, the worldwide biologics unit for AstraZeneca PLC, announced Amgen granted it rights to develop AMG 108 worldwide except in Japan. |
| · | In June 2009, Cytos Biotechnology AG announced the initiation of an ascending dose Phase 1/2a study of CYT013-IL1bQb, a therapeutic vaccine targeting IL-1 beta, in Type 2 diabetes. In June 2013, data were presented from a phase I, randomized, placebo-controlled, double-blinded, dose-escalation study in 48 type 2 diabetes patients at the 95th Endocrine Society Annual Meeting and Exposition. Decreases in HbA1c and glucose levels were observed. CYT-013-IL1bQb was reported to be safe and well-tolerated. |
| · | The following companies have completed or are conducting or planning Phase 3 clinical trials of the following products for the treatment of noninfectious intermediate, posterior or pan-uveitis: AbbVie - HUMIRA ® (adalimumab); Lux Biosciences, Inc. – LUVENIQ ® (voclosporin); Novartis - Myfortic ® (mycophenalate sodium) and secukinumab, Santen Pharmaceutical Co., Ltd. – Sirolimus® (rapamycin), and pSivida Corp. – Fluacinolone Acetonide Intravitreal. |
| · | Emergent Biosolutions Inc. has a contract with the U.S. Department of Health & Human Services, expected to be worth $423.0 million, to manufacture and supply an equine heptavalent botulism anti-toxin. In March 2013, the product was approved by the FDA. |
| · | imposition of government controls; |
| · | export license requirements; |
| · | political or economic instability; |
| · | trade restrictions; |
| · | changes in tariffs; |
| · | restrictions on repatriating profits; |
| · | exchange rate fluctuations; |
| · | withholding and other taxation; and |
| · | difficulties in staffing and managing international operations. |
| · | prevent our competitors from duplicating our products; |
| · | prevent our competitors from gaining access to our proprietary information and technology; or |
| · | permit us to gain or maintain a competitive advantage. |
| · | whether any pending or future patent applications held by us will result in an issued patent, or that if patents are issued to us, that such patents will provide meaningful protection against competitors or competitive technologies; |
| · | whether competitors will be able to design around our patents or develop and obtain patent protection for technologies, designs or methods that are more effective than those covered by our patents and patent applications; or |
| · | the extent to which our product candidates could infringe on the intellectual property rights of others, which may lead to costly litigation, result in the payment of substantial damages or royalties, and/or prevent us from using technology that is essential to our business. |
| · | require certain procedures to be followed and time periods to be met for any stockholder to propose matters to be considered at annual meetings of stockholders, including nominating directors for election at those meetings; and |
| · | authorize our Board of Directors to issue up to 1,000,000 shares of preferred stock without stockholder approval and to set the rights, preferences and other designations, including voting rights, of those shares as the Board of Directors may determine. |
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XOMA Corporation
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Date: August 7, 2014
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By:
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/s/ JOHN VARIAN
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John Varian
Chief Executive Officer (principal executive officer) and Director
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Date: August 7, 2014
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By:
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/s/ FRED KURLAND
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Fred Kurland
Vice President, Finance, Chief Financial Officer and Secretary
(principal financial and principal accounting officer)
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Incorporation By Reference
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Exhibit
Number
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Exhibit Description
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Form
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SEC File No.
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Exhibit
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Filing Date
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3.1
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Certificate of Incorporation of XOMA Corporation
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8-K
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000-14710
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3.1
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01/03/2012
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3.2
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Certificate of Amendment of Certificate of Incorporation of XOMA Corporation
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8-K
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000-14710
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3.1
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05/31/2012
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3.3
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By-laws of XOMA Corporation
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8-K
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000-14710
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3.2
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01/03/2012
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4.1
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Reference is made to Exhibits 3.1, 3.2 and 3.3
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4.2
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Specimen of Common Stock Certificate
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8-K
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000-14710
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4.1
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01/03/2012
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4.3
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Form of Certificate of Designations of Series A Preferred Stock
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8-K
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000-14710
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3.1
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01/03/2012
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4.4
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Form of Amended and Restated Warrant (June 2009 Warrants)
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8-K
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000-14710
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10.6
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02/02/2010
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4.5
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Form of Warrant (February 2010 Warrants)
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8-K
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000-14710
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10.2
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02/02/2010
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4.6
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Form of Warrant (December 2011 Warrants)
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10-K
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000-14710
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4.9
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03/14/2012
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4.7
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Form of Warrant (March 2012 Warrants)
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8-K
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000-14710
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4.1
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03/07/2012
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4.8
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Form of Warrant (September 2012 Warrants)
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8-K
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000-14710
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4.10
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10/03/2012
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| 4.9 | Registration Rights Agreement dated June 12, 2014, by and among XOMA Corporation, 667, L.P., Baker Brothers Life Sciences, L.P., and 14159, L.P. | 8-K | 00014710 | 4.1 | 06/12/2014 | |||||
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Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a)
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Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a)
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Certification of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)
(1)
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Press Release dated August 7, 2014
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101.INS
+
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XBRL Instance Document
(2)
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101.SCH
+
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XBRL Taxonomy Extension Schema Document
(2)
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101.CAL
+
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XBRL Taxonomy Extension Calculation Linkbase Document
(2)
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101.DEF
+
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XBRL Taxonomy Extension Definition Linkbase Document
(2)
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101.LAB
+
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XBRL Taxonomy Extension Labels Linkbase Document
(2)
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101.PRE
+
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XBRL Taxonomy Extension Presentation Linkbase Document
(2)
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| + | Filed herewith |
| ++ | Furnished herewith. The information in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections II and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in Exhibit 99.1 shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by XOMA Corporation, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
| (1) | This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing. |
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 |
|---|