· | Announced the selection of pyoderma gangrenosum (PG) as its next Phase 3 indication for gevokizumab based upon the compelling results generated from 6 patients enrolled in the Company’s PG clinical pilot program. In March 2014, the results will be shared with the FDA to determine the Phase 3 clinical protocol at an End of Phase 2 meeting. PG is one of a cluster of diseases under the umbrella of neutrophilic dermatosis. |
· | Reported Phase 2 data from the Company’s gevokizumab study in patients with moderate to severe inflammatory acne and completed a thorough analysis of the acne market. Rather than pursuing the broader acne indication, the Company will consider focusing on less prevalent but more severe acne indications that also are considered indications under the neutrophilic dermatosis umbrella. |
· | Reported promising results in October 2013, from the Day 84 pain and function endpoint in the Company’s gevokizumab Phase 2 study in patients with erosive osteoarthritis of the hand (EOA) and elevated C-reactive protein (CRP). Completed enrollment in a supplemental study in patients with EOA and non-elevated CRP. On March 4, 2014, XOMA reported that despite early positive results, the top-line data at Day 168 in the initial study, as well as at Day 84 in the supplemental study, were not positive and led to the Company’s decision not to pursue the broad EOA indication for Phase 3 testing. The Company will continue to review the data to determine if there is a specific segment of the EOA population that could benefit from gevokizumab therapy. |
· | Increased the pace of enrollment at 70 U.S. study sites participating in the gevokizumab EYEGUARD™-A and EYEGUARD-C studies. |
· | XOMA’s partner, SERVIER, continued to enroll patients in EYEGUARD-B, which is studying gevokizumab in patients who have non-infectious uveitis with underlying Behçet’s disease, a rare indication. |
· | As of yearend, SERVIER, had obtained approvals in 15 countries to conduct the EYEGUARD-A and -C clinical trials. These countries represent 53 clinical study centers. |
· | SERVIER initiated enrollment in three of its independent gevokizumab POC studies: polymyositis/dermatomyositis, Schnitzler's syndrome, and giant cell arteritis. |
· | Strengthened the Company’s financial position by raising $83.0 million in two public equity offerings, after deducting offering fees and out of pocket expenses. |
· | Received $8.6 million in milestone payments from 2 collaborators and licensees. |
· | Was awarded a patent for XOMA’s flexible manufacturing system. |
|
Three months ended
December 31,
|
Year ended
December 31,
|
||||||||||||||
|
2013
|
2012
|
2013
|
2012
|
||||||||||||
Revenues:
|
||||||||||||||||
License and collaborative fees
|
$
|
8,450
|
$
|
1,062
|
$
|
11,028
|
$
|
5,727
|
||||||||
Contract and other
|
4,084
|
6,330
|
24,423
|
28,055
|
||||||||||||
Total revenues
|
12,534
|
7,392
|
35,451
|
33,782
|
||||||||||||
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
22,946
|
15,765
|
74,851
|
68,467
|
||||||||||||
Selling, general and administrative
|
5,049
|
3,947
|
18,477
|
16,865
|
||||||||||||
Restructuring
|
119
|
299
|
328
|
5,074
|
||||||||||||
Total operating expenses
|
28,114
|
20,011
|
93,656
|
90,406
|
||||||||||||
|
||||||||||||||||
Loss from operations
|
(15,580
|
)
|
(12,619
|
)
|
(58,205
|
)
|
(56,624
|
)
|
||||||||
|
||||||||||||||||
Other (expense) income:
|
||||||||||||||||
Interest expense
|
(1,137
|
)
|
(1,176
|
)
|
(4,631
|
)
|
(4,387
|
)
|
||||||||
Other expense
|
(288
|
)
|
(414
|
)
|
(197
|
)
|
(956
|
)
|
||||||||
Revaluation of contingent warrant liabilities
|
(35,294
|
)
|
16,574
|
(61,039
|
)
|
(9,172
|
)
|
|||||||||
Net (loss) income before taxes
|
(52,298
|
)
|
2,365
|
(124,072
|
)
|
(71,139
|
)
|
|||||||||
|
||||||||||||||||
Provision for income tax (expense) benefit
|
(1
|
)
|
-
|
14
|
74
|
|||||||||||
|
||||||||||||||||
Net (loss) income
|
$
|
(52,299
|
)
|
$
|
2,365
|
$
|
(124,058
|
)
|
$
|
(71,065
|
)
|
|||||
|
||||||||||||||||
Basic and diluted net (loss) income per share of common stock
|
$
|
(0.55
|
)
|
$
|
0.03
|
$
|
(1.43
|
)
|
$
|
(1.10
|
)
|
|||||
|
||||||||||||||||
Shares used in computing basic net (loss) income per share of common stock
|
95,048
|
77,703
|
86,938
|
64,629
|
||||||||||||
Shares used in computing diluted net (loss) income per share of common stock
|
95,048
|
93,862
|
86,938
|
64,629
|
||||||||||||
|
||||||||||||||||
Other comprehensive (loss) income:
|
||||||||||||||||
Net (loss) income
|
(52,299
|
)
|
2,365
|
(124,058
|
)
|
$
|
(71,065
|
)
|
||||||||
Net unrealized (loss) gain on available-for-sale securities
|
(1
|
)
|
1
|
(9
|
)
|
8
|
||||||||||
Comprehensive (loss) income
|
$
|
(52,300
|
)
|
$
|
2,366
|
$
|
(124,067
|
)
|
$
|
(71,057
|
)
|
|
December 31,
|
|||||||
|
2013
|
2012
|
||||||
ASSETS
|
||||||||
Current assets:
|
|
|
||||||
Cash and cash equivalents
|
$
|
101,659
|
$
|
45,345
|
||||
Short-term investments
|
19,990
|
39,987
|
||||||
Trade and other receivables, net
|
3,781
|
8,249
|
||||||
Prepaid expenses and other current assets
|
1,630
|
2,256
|
||||||
Total current assets
|
127,060
|
95,837
|
||||||
Property and equipment, net
|
6,456
|
8,143
|
||||||
Other assets
|
1,266
|
1,696
|
||||||
Total assets
|
$
|
134,782
|
$
|
105,676
|
||||
|
||||||||
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
|
||||||||
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
9,616
|
$
|
3,867
|
||||
Accrued and other liabilities
|
9,934
|
13,045
|
||||||
Deferred revenue
|
2,218
|
3,409
|
||||||
Interest bearing obligation – current
|
5,835
|
3,391
|
||||||
Accrued interest on interest bearing obligation – current
|
2,042
|
121
|
||||||
Total current liabilities
|
29,645
|
23,833
|
||||||
Deferred revenue – long-term
|
4,105
|
6,315
|
||||||
Interest bearing obligations – long-term
|
35,150
|
37,653
|
||||||
Contingent warrant liabilities
|
69,869
|
15,001
|
||||||
Other liabilities - long-term
|
-
|
1,407
|
||||||
Total liabilities
|
138,769
|
84,209
|
||||||
|
||||||||
Stockholders’ (deficit) equity:
|
||||||||
Common stock, $0.0075 par value, 138,666,666 shares authorized, 105,386,216 and 82,447,274 shares outstanding at December 31, 2013 and 2012, respectively
|
787
|
615
|
||||||
Additional paid-in capital
|
1,076,403
|
977,962
|
||||||
Accumulated comprehensive (loss) income
|
(1
|
)
|
8
|
|||||
Accumulated deficit
|
(1,081,176
|
)
|
(957,118
|
)
|
||||
Total stockholders’ (deficit) equity
|
(3,987
|
)
|
21,467
|
|||||
Total liabilities and stockholders’ (deficit) equity
|
$
|
134,782
|
$
|
105,676
|