☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware
|
52-2154066
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
|
2910 Seventh Street, Berkeley,
California 94710
|
(510) 204-7200
|
|
(Address of principal executive offices, including zip code)
|
(Telephone Number)
|
Large accelerated filer
☐
|
Accelerated filer
☒
|
Non-accelerated filer
☐
|
Smaller reporting company ☐
|
(Do not check if a smaller reporting company)
|
Class
|
Outstanding at August 6, 2015
|
|
Common Stock, $0.0075 par value
|
118,584,036
|
Page
|
||
PART I FINANCIAL INFORMATION
|
|
|
Item 1.
|
|
|
1
|
||
2
|
||
3
|
||
4
|
||
Item 2.
|
19
|
|
Item 3.
|
29
|
|
Item 4.
|
29
|
|
PART II OTHER INFORMATION
|
|
|
Item 1.
|
30
|
|
Item 1A.
|
30
|
|
Item 2.
|
48
|
|
Item 3.
|
48
|
|
Item 4.
|
49
|
|
Item 5.
|
49
|
|
Item 6.
|
49
|
|
50
|
June 30,
2015 |
December 31,
2014 |
|||||||
(unaudited)
|
(Note 1)
|
|||||||
ASSETS
|
||||||||
Current assets:
|
|
|
||||||
Cash and cash equivalents
|
$
|
50,957
|
$
|
78,445
|
||||
Trade and other receivables, net
|
2,649
|
3,309
|
||||||
Prepaid expenses and other current assets
|
2,117
|
1,859
|
||||||
Total current assets
|
55,723
|
83,613
|
||||||
Property and equipment, net
|
4,455
|
5,120
|
||||||
Other assets
|
665
|
669
|
||||||
Total assets
|
$
|
60,843
|
$
|
89,402
|
||||
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
4,322
|
$
|
5,990
|
||||
Accrued and other liabilities
|
7,441
|
9,892
|
||||||
Deferred revenue - current
|
1,786
|
1,089
|
||||||
Interest bearing obligations – current
|
15,793
|
19,018
|
||||||
Accrued interest on interest bearing obligations – current
|
332
|
257
|
||||||
Total current liabilities
|
29,674
|
36,246
|
||||||
Deferred revenue – long-term
|
732
|
1,939
|
||||||
Interest bearing obligations – long-term
|
32,211
|
16,290
|
||||||
Contingent warrant liabilities
|
28,956
|
31,828
|
||||||
Other liabilities - long term
|
556
|
-
|
||||||
Total liabilities
|
92,129
|
86,303
|
||||||
Commitments and Contingencies (Note 7 and Note 9)
|
||||||||
Stockholders’ (deficit) equity:
|
||||||||
Preferred stock, $0.05 par value, 1,000,000 shares authorized, 0 issued and outstanding
|
-
|
-
|
||||||
Common stock, $0.0075 par value, 277,333,332 shares authorized, 117,969,465 and 115,892,450 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively
|
885
|
869
|
||||||
Additional paid-in capital
|
1,132,783
|
1,121,707
|
||||||
Accumulated deficit
|
(1,164,954
|
)
|
(1,119,477
|
)
|
||||
Total stockholders’ (deficit) equity
|
(31,286
|
)
|
3,099
|
|||||
Total liabilities and stockholders’ (deficit) equity
|
$
|
60,843
|
$
|
89,402
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
Revenues:
|
|
|
|
|
||||||||||||
License and collaborative fees
|
$
|
945
|
$
|
1,201
|
$
|
1,207
|
$
|
2,164
|
||||||||
Contract and other
|
1,594
|
4,772
|
3,983
|
7,219
|
||||||||||||
Total revenues
|
2,539
|
5,973
|
5,190
|
9,383
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
19,692
|
19,590
|
39,696
|
41,136
|
||||||||||||
Selling, general and administrative
|
5,060
|
5,160
|
10,280
|
10,414
|
||||||||||||
Restructuring
|
-
|
-
|
-
|
84
|
||||||||||||
Total operating expenses
|
24,752
|
24,750
|
49,976
|
51,634
|
||||||||||||
Loss from operations
|
(22,213
|
)
|
(18,777
|
)
|
(44,786
|
)
|
(42,251
|
)
|
||||||||
Other income (expense):
|
||||||||||||||||
Interest expense
|
(1,007
|
)
|
(1,110
|
)
|
(2,123
|
)
|
(2,236
|
)
|
||||||||
Other income (expense), net
|
(363
|
)
|
27
|
1,648
|
(61
|
)
|
||||||||||
Revaluation of contingent warrant liabilities
|
(176
|
)
|
7,963
|
(216
|
)
|
27,964
|
||||||||||
Net loss
|
$
|
(23,759
|
)
|
$
|
(11,897
|
)
|
$
|
(45,477
|
)
|
$
|
(16,584
|
)
|
||||
Basic net loss per share of common stock
|
$
|
(0.20
|
)
|
$
|
(0.11
|
)
|
$
|
(0.39
|
)
|
$
|
(0.16
|
)
|
||||
Diluted net loss per share of common stock
|
$
|
(0.20
|
)
|
$
|
(0.17
|
)
|
$
|
(0.39
|
)
|
$
|
(0.38
|
)
|
||||
Shares used in computing basic net loss per share of common stock
|
117,540
|
106,927
|
116,870
|
106,545
|
||||||||||||
Shares used in computing diluted net loss per share of common stock
|
117,540
|
114,126
|
116,870
|
115,048
|
||||||||||||
Other comprehensive loss:
|
||||||||||||||||
Net loss
|
$
|
(23,759
|
)
|
$
|
(11,897
|
)
|
$
|
(45,477
|
)
|
$
|
(16,584
|
)
|
||||
Net unrealized (loss) gain on available-for-sale securities
|
-
|
(1
|
)
|
-
|
7
|
|||||||||||
Comprehensive loss
|
$
|
(23,759
|
)
|
$
|
(11,898
|
)
|
$
|
(45,477
|
)
|
$
|
(16,577
|
)
|
Six Months Ended June 30,
|
||||||||
2015
|
2014
|
|||||||
Cash flows from operating activities:
|
|
|
||||||
Net loss
|
$
|
(45,477
|
)
|
$
|
(16,584
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
902
|
941
|
||||||
Common stock contribution to 401(k)
|
986
|
870
|
||||||
Stock-based compensation expense
|
6,354
|
6,348
|
||||||
Revaluation of contingent warrant liabilities
|
216
|
(27,964
|
)
|
|||||
Amortization of debt discount, final payment fee on debt, and debt issuance costs
|
656
|
1,362
|
||||||
Loss on loan extinguishment
|
429
|
-
|
||||||
Unrealized gain on foreign currency exchange
|
(1,571
|
)
|
(241
|
)
|
||||
Unrealized loss on foreign exchange options
|
6
|
239
|
||||||
Other non-cash adjustments
|
-
|
(2
|
)
|
|||||
Changes in assets and liabilities:
|
||||||||
Trade and other receivables, net
|
660
|
(1,728
|
)
|
|||||
Prepaid expenses and other current assets
|
(258
|
)
|
(491
|
)
|
||||
Accounts payable and accrued liabilities
|
(3,954
|
)
|
(5,179
|
)
|
||||
Accrued interest on interest bearing obligations
|
210
|
(1,570
|
)
|
|||||
Deferred revenue
|
(342
|
)
|
(1,019
|
)
|
||||
Other liabilities
|
556
|
(81
|
)
|
|||||
Net cash used in operating activities
|
(40,627
|
)
|
(45,099
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Proceeds from maturities of investments
|
-
|
10,000
|
||||||
Net purchase of property and equipment
|
(406
|
)
|
(80
|
)
|
||||
Net cash (used in) provided by investing activities
|
(406
|
)
|
9,920
|
|||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of common stock, net of issuance costs
|
211
|
3,213
|
||||||
Proceeds from exercise of warrants
|
1
|
35
|
||||||
Proceeds from issuance of long term debt
|
20,000
|
-
|
||||||
Debt issuance costs and loan fees
|
(512
|
)
|
-
|
|||||
Principal payments of debt
|
(6,128
|
)
|
(3,833
|
)
|
||||
Net cash provided by (used in) financing activities
|
13,572
|
(585
|
)
|
|||||
Effect of exchange rate changes on cash
|
(27
|
)
|
-
|
|||||
Net decrease in cash and cash equivalents
|
(27,488
|
)
|
(35,764
|
)
|
||||
Cash and cash equivalents at the beginning of the period
|
78,445
|
101,659
|
||||||
Cash and cash equivalents at the end of the period
|
$
|
50,957
|
$
|
65,895
|
||||
Supplemental Cash Flow Information:
|
||||||||
Cash paid for:
|
||||||||
Interest
|
$
|
792
|
$
|
2,413
|
||||
Non-cash financing activities:
|
||||||||
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
$
|
(3,088
|
)
|
$
|
(2,526
|
)
|
||
Interest added to principal balances on long-term debt
|
$
|
159
|
$
|
157
|
||||
Issuance of common stock warrants in connection with Hercules Term Loan
|
$
|
450
|
$
|
-
|
1.
|
Description of Business
|
2.
|
Basis of Presentation and Significant Accounting Policies
|
June 30, 2015
|
December 31, 2014
|
|||||||||||||||||||||||
Prior to Adoption of ASU 2015-03
|
ASU 2015-03 Adjustment
|
As Adopted
|
Prior to Adoption of ASU 2015-03
|
ASU 2015-03 Adjustment
|
As Adopted
|
|||||||||||||||||||
|
|
|
|
|
|
|||||||||||||||||||
Prepaid expenses and other current assets
|
$
|
2,305
|
$
|
(188
|
)
|
$
|
2,117
|
$
|
2,088
|
$
|
(229
|
)
|
$
|
1,859
|
||||||||||
Total current assets
|
$
|
55,911
|
$
|
(188
|
)
|
$
|
55,723
|
$
|
83,842
|
$
|
(229
|
)
|
$
|
83,613
|
||||||||||
Other assets
|
$
|
931
|
$
|
(266
|
)
|
$
|
665
|
$
|
669
|
$
|
-
|
$
|
669
|
|||||||||||
Total assets
|
$
|
61,297
|
$
|
(454
|
)
|
$
|
60,843
|
$
|
89,631
|
$
|
(229
|
)
|
$
|
89,402
|
||||||||||
Interest bearing obligations – current
|
$
|
15,981
|
$
|
(188
|
)
|
$
|
15,793
|
$
|
19,247
|
$
|
(229
|
)
|
$
|
19,018
|
||||||||||
Total current liabilities
|
$
|
29,862
|
$
|
(188
|
)
|
$
|
29,674
|
$
|
36,475
|
$
|
(229
|
)
|
$
|
36,246
|
||||||||||
Interest bearing obligations – long-term
|
$
|
32,477
|
$
|
(266
|
)
|
$
|
32,211
|
$
|
16,290
|
$
|
-
|
$
|
16,290
|
|||||||||||
Total liabilities
|
$
|
92,583
|
$
|
(454
|
)
|
$
|
92,129
|
$
|
86,532
|
$
|
(229
|
)
|
$
|
86,303
|
3.
|
Condensed Consolidated Financial Statements Detail
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
Common stock options and RSUs
|
8,362
|
7,939
|
7,850
|
6,576
|
||||||||||||
Warrants for common stock
|
19,087
|
1,910
|
19,087
|
1,910
|
||||||||||||
Total
|
27,449
|
9,849
|
26,937
|
8,486
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
Numerator
|
|
|
|
|
||||||||||||
Net loss
|
|
|
|
|
||||||||||||
Basic
|
$
|
(23,759
|
)
|
$
|
(11,897
|
)
|
$
|
(45,477
|
)
|
$
|
(16,584
|
)
|
||||
Adjustment for revaluation of contingent warrant liabilities
|
-
|
(7,616
|
)
|
-
|
(27,150
|
)
|
||||||||||
Diluted
|
$
|
(23,759
|
)
|
$
|
(19,513
|
)
|
$
|
(45,477
|
)
|
$
|
(43,734
|
)
|
||||
Denominator
|
||||||||||||||||
Weighted average shares outstanding used for basic net loss per share
|
117,540
|
106,927
|
116,870
|
106,545
|
||||||||||||
Effect of dilutive warrants
|
-
|
7,199
|
-
|
8,503
|
||||||||||||
Weighted average shares outstanding and dilutive securities used for diluted net loss per share
|
117,540
|
114,126
|
116,870
|
115,048
|
June 30,
2015 |
December 31,
2014 |
|||||||
Accrued payroll and other benefits
|
$
|
2,851
|
$
|
3,061
|
||||
Accrued management incentive compensation
|
2,300
|
4,295
|
||||||
Accrued clinical trial costs
|
1,081
|
1,424
|
||||||
Other
|
1,209
|
1,112
|
||||||
Total
|
$
|
7,441
|
$
|
9,892
|
4.
|
Collaborative and Other Agreements
|
5.
|
Fair Value Measurements
|
Fair Value Measurements at June 30, 2015 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)
|
$
|
32,079
|
$
|
-
|
$
|
-
|
$
|
32,079
|
||||||||
Liabilities:
|
||||||||||||||||
Contingent warrant liabilities
|
$
|
-
|
$
|
-
|
$
|
28,956
|
$
|
28,956
|
||||||||
Fair Value Measurements at December 31, 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)
|
$
|
67,569
|
$
|
-
|
$
|
-
|
$
|
67,569
|
||||||||
Foreign exchange options
(2)
|
-
|
6
|
-
|
6
|
||||||||||||
Total
|
$
|
67,569
|
$
|
6
|
$
|
-
|
$
|
67,575
|
||||||||
Liabilities:
|
||||||||||||||||
Contingent warrant liabilities
|
$
|
-
|
$
|
-
|
$
|
31,828
|
$
|
31,828
|
(1) | Included in cash and cash equivalents |
(2) | Included in other assets |
|
June 30,
2015 |
December 31,
2014 |
||||||
|
|
|
||||||
Expected volatility
|
69.8% - 70.9
|
%
|
69.6% - 72.9
|
%
|
||||
Risk-free interest rate
|
0.29% - 0.69
|
%
|
0.03% - 0.67
|
%
|
||||
Expected term
|
1.44 - 1.69 years
|
0.09 - 2.19 years
|
Balance at December 31, 2014
|
$
|
31,828
|
||
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
(3,088
|
)
|
||
Net increase in estimated fair value of contingent warrant liabilities upon revaluation
|
216
|
|||
Balance at June 30, 2015
|
$
|
28,956
|
June 30, 2015
|
December 31, 2014
|
|||||||||||||||
Carrying Amount
|
Fair Value
|
Carrying Amount
|
Fair Value
|
|||||||||||||
Interest bearing obligations
|
$
|
48,004
|
$
|
49,686
|
$
|
35,308
|
$
|
36,461
|
6.
|
Long-Term Debt and Other Financings
|
Six months ending December 31, 2015
|
$
|
14,746
|
||
Year ended 2016
|
9,118
|
|||
Year ended 2017
|
14,787
|
|||
Year ended 2018
|
18,016
|
|||
56,667
|
||||
Less: Interest, final payment fee, discount and issuance cost
|
(8,663
|
)
|
||
48,004
|
||||
Less: current portion
|
(15,793
|
)
|
||
$
|
32,211
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
Hercules loan
|
$
|
652
|
$
|
-
|
$
|
886
|
$
|
-
|
||||||||
Servier loan
|
272
|
600
|
527
|
1,188
|
||||||||||||
GECC term loan
|
-
|
423
|
548
|
870
|
||||||||||||
Novartis note
|
80
|
78
|
159
|
155
|
||||||||||||
Other
|
3
|
9
|
3
|
23
|
||||||||||||
Total interest expense
|
$
|
1,007
|
$
|
1,110
|
$
|
2,123
|
$
|
2,236
|
7.
|
Commitments and Contingencies
|
8.
|
Stock-based Compensation
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
Dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||||
Expected volatility
|
81
|
%
|
91
|
%
|
82
|
%
|
93
|
%
|
||||||||
Risk-free interest rate
|
1.65
|
%
|
1.68
|
%
|
1.40
|
%
|
1.71
|
%
|
||||||||
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) |
|||||||||||||
Outstanding at January 1, 2015
|
7,702,309
|
$
|
8.15
|
|
|
|||||||||||
Granted
|
1,636,639
|
3.74
|
|
|
||||||||||||
Exercised
|
(104,438
|
)
|
1.54
|
|
|
|||||||||||
Forfeited, expired or cancelled
|
(771,854
|
)
|
21.84
|
|
|
|||||||||||
Outstanding at June 30, 2015
|
8,462,656
|
$
|
6.13
|
7.24
|
$
|
4,107
|
||||||||||
Vested and expected to vest at June 30, 2015
|
8,118,591
|
$
|
6.20
|
7.16
|
$
|
4,054
|
||||||||||
Exercisable at June 30, 2015
|
5,172,965
|
$
|
7.15
|
6.20
|
$
|
3,179
|
Number of
Shares
|
Weighted-
Average Grant-
Date Fair Value
|
|||||||
Unvested balance at January 1, 2015
|
1,953,879
|
$
|
5.46
|
|||||
Granted
|
1,586,017
|
3.78
|
||||||
Vested
|
(881,832
|
)
|
4.86
|
|||||
Forfeited
|
139,308
|
4.54
|
||||||
Unvested balance at June 30, 2015
|
2,797,372
|
$
|
4.65
|
Three Months Ended June 30
|
Six Months Ended June 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
Research and development
|
$
|
1,399
|
$
|
953
|
$
|
3,595
|
$
|
3,359
|
||||||||
Selling, general and administrative
|
1,290
|
1,471
|
2,759
|
2,989
|
||||||||||||
Total stock-based compensation expense
|
$
|
2,689
|
$
|
2,424
|
$
|
6,354
|
$
|
6,348
|
9.
|
Subsequent
Events
|
Three Months Ended June 30,
|
Increase
|
Six Months Ended June 30,
|
Increase
|
|||||||||||||||||||||
2015
|
2014
|
(Decrease)
|
2015
|
2014
|
(Decrease)
|
|||||||||||||||||||
License and collaborative fees
|
$
|
945
|
$
|
1,201
|
$
|
(256
|
)
|
$
|
1,207
|
$
|
2,164
|
$
|
(957
|
)
|
||||||||||
Contract and other
|
1,594
|
4,772
|
(3,178
|
)
|
3,983
|
7,219
|
(3,236
|
)
|
||||||||||||||||
Total revenues
|
$
|
2,539
|
$
|
5,973
|
$
|
(3,434
|
)
|
$
|
5,190
|
$
|
9,383
|
$
|
(4,193
|
)
|
Three Months Ended June 30,
|
Increase
|
Six Months Ended June 30,
|
Increase
|
|||||||||||||||||||||
2015
|
2014
|
(Decrease)
|
2015
|
2014
|
(Decrease)
|
|||||||||||||||||||
NIAID
|
$
|
1,229
|
$
|
3,580
|
$
|
(2,351
|
)
|
$
|
3,131
|
$
|
5,176
|
$
|
(2,045
|
)
|
||||||||||
Servier
|
346
|
1,076
|
(730
|
)
|
870
|
1,959
|
(1,089
|
)
|
||||||||||||||||
Other
|
19
|
116
|
(97
|
)
|
(18
|
)
|
84
|
(102
|
)
|
|||||||||||||||
Total contract and other revenues
|
$
|
1,594
|
$
|
4,772
|
$
|
(3,178
|
)
|
$
|
3,983
|
$
|
7,219
|
$
|
(3,236
|
)
|
Three Months Ended June 30,
|
Increase
|
Six Months Ended June 30,
|
Increase
|
|||||||||||||||||||||
2015
|
2014
|
(Decrease)
|
2015
|
2014
|
(Decrease)
|
|||||||||||||||||||
Earlier stage programs
|
$
|
4,479
|
$
|
9,521
|
$
|
(5,042
|
)
|
$
|
10,252
|
$
|
20,448
|
$
|
(10,196
|
)
|
||||||||||
Later stage programs
|
15,213
|
10,069
|
5,144
|
29,444
|
20,688
|
8,756
|
||||||||||||||||||
Total
|
$
|
19,692
|
$
|
19,590
|
$
|
102
|
$
|
39,696
|
$
|
41,136
|
$
|
(1,440
|
)
|
Three Months Ended June 30,
|
Increase
|
Six Months Ended June 30,
|
Increase
|
|||||||||||||||||||||
2015
|
2014
|
(Decrease)
|
2015
|
2014
|
(Decrease)
|
|||||||||||||||||||
Internal projects
|
$
|
13,906
|
$
|
11,104
|
$
|
2,802
|
$
|
27,570
|
$
|
26,073
|
$
|
1,497
|
||||||||||||
Collaborative and contract arrangements
|
5,786
|
8,486
|
(2,700
|
)
|
12,126
|
15,063
|
(2,937
|
)
|
||||||||||||||||
Total
|
$
|
19,692
|
$
|
19,590
|
$
|
102
|
$
|
39,696
|
$
|
41,136
|
$
|
(1,440
|
)
|
|
Three Months Ended June 30,
|
Increase
|
Six Months Ended June 30,
|
Increase
|
||||||||||||||||||||
|
2015
|
2014
|
(Decrease)
|
2015
|
2014
|
(Decrease)
|
||||||||||||||||||
Hercules loan
|
$
|
652
|
$
|
-
|
$
|
652
|
$
|
886
|
$
|
-
|
$
|
886
|
||||||||||||
Servier loan
|
272
|
600
|
(328
|
)
|
527
|
1,188
|
(661
|
)
|
||||||||||||||||
GECC term loan
|
-
|
423
|
(423
|
)
|
548
|
870
|
(322
|
)
|
||||||||||||||||
Novartis note
|
80
|
78
|
2
|
159
|
155
|
4
|
||||||||||||||||||
Other
|
3
|
9
|
(6
|
)
|
3
|
23
|
(20
|
)
|
||||||||||||||||
Total interest expense
|
$
|
1,007
|
$
|
1,110
|
$
|
(103
|
)
|
$
|
2,123
|
$
|
2,236
|
$
|
(113
|
)
|
Three Months Ended June 30,
|
Increase
|
Six Months Ended June 30,
|
Increase
|
|||||||||||||||||||||
Other income (expense), net
|
2015
|
2014
|
(Decrease)
|
2015
|
2014
|
(Decrease)
|
||||||||||||||||||
Unrealized foreign exchange gain (loss)
(1)
|
$
|
(378
|
)
|
$
|
175
|
$
|
(553
|
)
|
$
|
1,571
|
$
|
241
|
$
|
1,330
|
||||||||||
Realized foreign exchange gain (loss)
|
6
|
-
|
6
|
62
|
-
|
62
|
||||||||||||||||||
Unrealized loss on foreign exchange options
|
-
|
(116
|
)
|
116
|
(6
|
)
|
(239
|
)
|
233
|
|||||||||||||||
Other
|
9
|
(32
|
)
|
41
|
21
|
(63
|
)
|
84
|
||||||||||||||||
Total other income (expense), net
|
$
|
(363
|
)
|
$
|
27
|
$
|
(390
|
)
|
$
|
1,648
|
$
|
(61
|
)
|
$
|
1,709
|
(1) | Unrealized foreign exchange gain (loss) for the three and six months ended June 30, 2015 and 2014 primarily relates to the re-measurement of the €15 million Servier loan. |
|
June 30,
2015
|
December 31,
2014
|
Increase
(Decrease)
|
|||||||||
Cash and cash equivalents
|
$
|
50,957
|
$
|
78,445
|
$
|
(27,488
|
)
|
|||||
Working Capital
|
$
|
26,049
|
$
|
47,367
|
$
|
(21,318
|
)
|
Six Months Ended June 30,
|
Increase
|
|||||||||||
2015
|
2014
|
(Decrease)
|
||||||||||
|
|
|
||||||||||
Net cash used in operating activities
|
$
|
(40,627
|
)
|
$
|
(45,099
|
)
|
$
|
4,472
|
||||
Net cash (used in) provided by investing activities
|
(406
|
)
|
9,920
|
(10,326
|
)
|
|||||||
Net cash provided by (used in) financing activities
|
13,572
|
(585
|
)
|
14,157
|
||||||||
Effect of exchange rate changes on cash
|
(27
|
)
|
-
|
(27
|
)
|
|||||||
Net decrease in cash and cash equivalents
|
$
|
(27,488
|
)
|
$
|
(35,764
|
)
|
$
|
8,276
|
Six months ending December 31, 2015
|
$
|
14,746
|
||
Year ended 2016
|
9,118
|
|||
Year ended 2017
|
14,787
|
|||
Year ended 2018
|
18,016
|
|||
56,667
|
||||
Less: Interest, final payment fee, discount and issuance cost
|
(8,663
|
)
|
||
48,004
|
||||
Less current portion
|
(15,793
|
)
|
||
$
|
32,211
|
• | terminate or delay clinical trials for one or more of our product candidates; reduce or eliminate certain product development efforts or commercialization efforts; |
• | 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 disease 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 disease 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 December 31, 2014, the €15.0 million outstanding principal balance under this Servier Loan Agreement would have equaled approximately $18.2 million using the December 31, 2014 Euro-to-U.S.-dollar exchange rate of 1.216. |
• | On January 9, 2015, Servier and we entered into Amendment No. 2 (“Loan Amendment”). The Servier Loan Agreement was initially entered into on December 30, 2010 and subsequently amended by a Consent, Transfer, Assumption and Amendment Agreement entered into as of August 12, 2013. The Loan Amendment modifies the maturity date of the loan from January 13, 2016 to three tranches due on January 15, 2016, January 15, 2017 and January 15, 2018 and provides that principal shall be repaid as follows: €3.0 million to be repaid on January 15, 2016, €5.0 million to be repaid on January 15, 2017 and €7.0 million to be repaid on January 15, 2018. All other terms of the Loan Agreement remain unchanged, including the interest rate calculations, EURIBOR+2% and the formula for resetting the interest rate on the 15th of January and 15 th of July every six months. |
• | On January 9, 2015, Servier and we entered into an Amendment No. 2 to the Collaboration Agreement. Under the Collaboration Agreement we were eligible to receive up to approximately €356.5 million in the aggregate in milestone payments, most of which were denominated in Euros, if we re-acquire cardiovascular and/or diabetes rights for use in the United States, and approximately €633.8 million in aggregate milestone payments if we do not re-acquire those rights. Under the Collaboration Amendment, we would be eligible to receive up to €341.5 million in the aggregate in milestone payments in the event we re-acquire the cardiovascular and/or diabetes rights for use in the United States and approximately €618.8 million if we do not re-acquire those rights. The milestone reductions are related to a low prevalence indication of which Servier would not have pursued development had these payments been required. All other terms of the Collaboration Agreement remain unchanged. |
• | 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; |
• | we will be able to provide necessary data; |
• | results of future clinical trials will justify further development; or |
• | we ultimately will achieve regulatory approval for our 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 including CD40 and prolactin receptor antibody programs. In exchange for cash and debt reduction on our existing loan facility with Novartis, Novartis received control over the CD40 and prolactin receptor antibody programs, as well as the right to expand the development of these programs into additional indications outside of oncology. Novartis has initiated clinical studies to test CFZ533, an anti-CD40 antibody arising from its collaboration with XOMA, in de novo renal transplantation, in Primary Sjögren's Syndrome and in rheumatoid arthritis. Novartis has returned control of the prolactin receptor antibody program to us, and we have announced in August 2015 our intention for its continued development in hyperprolactenimic indications. |
• | 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, a set of enabling technologies 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 March 9, 2015, we were aware of three products manufactured using this technology that have received FDA approval: Genentech’s LUCENTIS® (ranibizumab injection) for treatment of neovascular wet age-related macular degeneration, Macular Edema Following Vein Occulsion, Diabetic Macular Edema, and Diabetic Retinopathy in patients with Diabetic Macular Edema; UCB’s CIMZIA® (certolizumab pegol) for treatment of Crohn’s disease and rheumatoid arthritis; and Pfizer’s TRUMENBA®, a meningococcal group B vaccine. 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. We anticipate receiving a fraction of a percentage royalty on sales of TRUMENBA. |
• | In August 2012, Servier and we announced an agreement with Boehringer Ingelheim to transfer XOMA's technology and processes for the validation of our technology and processes in preparation for the potential commercial manufacture of gevokizumab. Boehringer Ingelheim has completed GMP runs with successful biological comparability, including all process validation batches of the XOMA processes. |
• | 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 U.S. 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 urticarial (“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; tumor necrosis factor receptor-associated periodic syndrome (“TRAPS”); xerophthalmia; Schnitzler syndrome; polymyalgia rheumatica; hyperimmunoglobulinemia D (hyper-IgD) and periodic fever syndrome (“HIDS”); and abdominal aortic aneurysm (“AAA”). |
• | Regeneron markets and is developing ARCALYSTt® (rilonacept), an interleukin-1 blocker currently indicated in the U.S. for the treatment of CAPS, including FCAS and MWS in adults and children 12 and older. Rilonacept is also approved, but not marketed, in the EU for the same patient population. |
• | 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 investigating Kineret in patients with a certain type of myocardial infarction, or heart attack, has been completed in the United Kingdom. In January 2013, Biovitrum 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 China Food and Drug Administration (“SFDA”); in January 2012, supplemental materials were required by the SFDA to conclude the review. |
• | 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); Novartis - Myfortic® (mycophenalate sodium); Santen Pharmaceutical Co., Ltd. - Opsiria® (intravitreal sirolimus); pSivida Corp. - Fluocinolone Acetonide Intravitreal; and Allergan - Ozurdex® (dexamethasone). |
• | 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; and |
• | withholding and other taxation. |
• | 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. |
XOMA Corporation
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||
Date: August 10, 2015
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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 10, 2015
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By:
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/s/ THOMAS BURNS
|
Thomas Burns
Vice President, Finance and Chief Financial Officer
(principal financial and principal accounting officer)
|
Incorporation By Reference
|
||||||||||
Exhibit
Number
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Exhibit Description
|
Form
|
SEC File No.
|
Exhibit
|
Filing Date
|
|||||
3.1
|
Certificate of Incorporation of XOMA Corporation
|
8-K
|
000-14710
|
3.1
|
01/03/2012
|
|||||
3.2
|
Certificate of Amendment of Certificate of Incorporation of XOMA Corporation
|
8-K
|
000-14710
|
3.1
|
05/31/2012
|
|||||
3.3
|
By-laws of XOMA Corporation
|
8-K
|
000-14710
|
3.2
|
01/03/2012
|
|||||
4.1
|
Reference is made to Exhibits 3.1, 3.2 and 3.3
|
|||||||||
4.2
|
Specimen of Common Stock Certificate
|
8-K
|
000-14710
|
4.1
|
01/03/2012
|
|||||
4.3
|
Form of Warrant (December 2011 Warrants)
|
10-K
|
000-14710
|
4.9
|
03/14/2012
|
|||||
4.4
|
Form of Warrant (March 2012 Warrants)
|
8-K
|
000-14710
|
4.1
|
03/07/2012
|
|||||
4.5
|
Form of Warrant (September 2012 Warrants)
|
8-K
|
000-14710
|
4.10
|
10/03/2012
|
|||||
4.6
|
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
|
000-14710
|
4.1
|
06/12/2014
|
|||||
4.7
|
Form of Warrant (December 2014 Warrants)
|
8-K
|
000-14710
|
4.1
|
12/09/2014
|
|||||
4.8
|
Form of Warrant (February 2015 Warrants)
|
10-Q
|
000-14710
|
4.10
|
05/07/2015
|
|||||
10.1
+
|
Letter Agreement, dated June 19, 2015, by and between XOMA (US) LLC and Novartis Vaccines and Diagnostics, Inc.
|
31.1
+
|
Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a)
|
|||||||||
31.2
+
|
Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a)
|
|||||||||
32.1
+
|
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)
|
|||||||||
101.INS
+
|
XBRL Instance Document
|
|||||||||
101.SCH
+
|
XBRL Taxonomy Extension Schema Document
|
|||||||||
101.CAL
+
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|||||||||
101.DEF
+
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|||||||||
101.LAB
+
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|||||||||
101.PRE
+
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+ | Filed herewith |
* | Indicates management contract or compensatory plan. |
(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. |
Re:
|
Secured Note Agreement – Extension of Maturity Date
|
Very truly yours,
|
||
NOVARTIS VACCINES AND DIAGNOSTICS, INC.
|
||
By:
|
/s/ Maria A. Rocco-Ichikawa
|
|
Name:
|
Maria A. Rocco-Ichikawa
|
|
Title:
|
Director Finance NIBR
|
1. | I have reviewed this quarterly report on Form 10-Q of XOMA Corporation; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
/s/ JOHN VARIAN
|
|
Date: August 10, 2015
|
John Varian
Chief Executive Officer
|
1. | I have reviewed this quarterly report on Form 10-Q of XOMA Corporation; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
/s/ THOMAS BURNS
|
|
Date: August 10, 2015
|
Thomas Burns
Vice President, Finance, and Chief Financial Officer
|
/s/ JOHN VARIAN
|
|
John Varian
Chief Executive Officer
|
|
/s/ THOMAS BURNS
|
|
Thomas Burns
Vice President, Finance, and Chief Financial Officer
|