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
|
Bermuda
|
|
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 o
|
|
Accelerated filer x
|
|
Non-accelerated filer o
(Do not check if a smaller reporting company)
|
|
Smaller reporting company o
|
Class
|
Outstanding at August 2, 2011
|
Common Shares, U.S. $0.0075 par value
|
32,554,155
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Page
|
|||
PART I FINANCIAL INFORMATION
|
|||
Item 1.
|
Condensed Consolidated Financial Statements (unaudited)
|
||
1
|
|||
2
|
|||
3
|
|||
4
|
|||
Item 2.
|
14
|
||
Item 3.
|
22
|
||
Item 4.
|
23
|
||
PART II OTHER INFORMATION
|
|||
Item 1.
|
23
|
||
Item 1A.
|
24
|
||
Item 2.
|
41
|
||
Item 3.
|
41
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||
Item 4.
|
41
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Item 5.
|
41
|
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Item 6.
|
42
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43
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June 30,
2011
|
December 31,
2010
|
|||||||
(unaudited)
|
(Note 1)
|
|||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
$ | 51,157 | $ | 37,304 | |||||
Trade and other receivables, net
|
11,059 | 20,864 | ||||||
Prepaid expenses and other current assets
|
807 | 712 | ||||||
Total current assets
|
63,023 | 58,880 | ||||||
Property and equipment, net
|
14,410 | 14,869 | ||||||
Other assets
|
2,165 | 503 | ||||||
Total assets
|
$ | 79,598 | $ | 74,252 | ||||
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 5,043 | $ | 3,581 | ||||
Accrued liabilities
|
7,087 | 10,658 | ||||||
Deferred revenue
|
5,982 | 17,044 | ||||||
Warrant liabilities
|
1,395 | 4,245 | ||||||
Total current liabilities
|
19,507 | 35,528 | ||||||
Deferred revenue – long-term
|
8,665 | 1,086 | ||||||
Interest bearing obligations – long-term
|
27,031 | 13,694 | ||||||
Other long-term liabilities
|
257 | 353 | ||||||
Total liabilities
|
55,460 | 50,661 | ||||||
Shareholders’ equity:
|
||||||||
Preference shares, $0.05 par value, 1,000,000 shares authorized
|
||||||||
Series B, 8,000 designated, 0 and 2,959 shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively
|
- | 1 | ||||||
Common shares, $0.0075 par value, 92,666,666 shares authorized, 32,200,731 and 28,491,318 shares outstanding at June 30, 2011 and December 31, 2010, respectively
|
241 | 214 | ||||||
Additional paid-in capital
|
891,672 | 876,686 | ||||||
Accumulated comprehensive income
|
1 | - | ||||||
Accumulated deficit
|
(867,776 | ) | (853,310 | ) | ||||
Total shareholders’ equity
|
24,138 | 23,591 | ||||||
Total liabilities and shareholders’ equity
|
$ | 79,598 | $ | 74,252 |
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Revenues:
|
||||||||||||||||
License and collaborative fees
|
$ | 6,039 | $ | 150 | $ | 11,866 | $ | 339 | ||||||||
Contract and other revenue
|
10,467 | 5,481 | 20,128 | 12,292 | ||||||||||||
Royalties
|
19 | 311 | 126 | 513 | ||||||||||||
Total revenues
|
16,525 | 5,942 | 32,120 | 13,144 | ||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
18,281 | 19,346 | 35,628 | 36,933 | ||||||||||||
Selling, general and administrative
|
6,113 | 5,026 | 11,483 | 10,579 | ||||||||||||
Total operating expenses
|
24,394 | 24,372 | 47,111 | 47,512 | ||||||||||||
Loss from operations
|
(7,869 | ) | (18,430 | ) | (14,991 | ) | (34,368 | ) | ||||||||
Other income (expense):
|
||||||||||||||||
Investment and interest income
|
18 | 6 | 28 | 9 | ||||||||||||
Interest expense
|
(634 | ) | (90 | ) | (1,166 | ) | (177 | ) | ||||||||
Other income (expense)
|
355 | 2,950 | 1,678 | (2,813 | ) | |||||||||||
Net loss before taxes
|
(8,130 | ) | (15,564 | ) | (14,451 | ) | (37,349 | ) | ||||||||
Provision for income tax expense
|
- | (16 | ) | (15 | ) | (16 | ) | |||||||||
Net loss
|
$ | (8,130 | ) | $ | (15,580 | ) | $ | (14,466 | ) | $ | (37,365 | ) | ||||
Basic and diluted net loss per common share
|
$ | (0.27 | ) | $ | (0.93 | ) | $ | (0.49 | ) | $ | (2.24 | ) | ||||
Shares used in computing basic and diluted net loss per common share
|
29,889 | 16,695 | 29,536 | 16,695 |
Six Months Ended June 30,
|
||||||||
2011
|
2010
|
|||||||
Cash flows from operating activities:
|
||||||||
$ | (14,466 | ) | $ | (37,365 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
2,702 | 2,956 | ||||||
Common shares contribution to 401(k)
|
1,046 | 905 | ||||||
Share-based compensation expense
|
4,056 | 2,081 | ||||||
Accrued interest on interest bearing obligations
|
495 | 164 | ||||||
Revaluation of warrant liabilities
|
(2,850 | ) | (1,691 | ) | ||||
Warrant modification expense
|
- | 4,500 | ||||||
Amortization of discount on long-term debt
|
661 | - | ||||||
Unrealized loss on foreign currency exchange
|
1,876 | - | ||||||
Unrealized gain on foreign exchange options
|
(156 | ) | - | |||||
Other non-cash adjustments
|
11 | 12 | ||||||
Changes in assets and liabilities affecting cash:
|
||||||||
Receivables
|
9,805 | (1,285 | ) | |||||
Prepaid expenses and other assets
|
(1,601 | ) | (863 | ) | ||||
Accounts payable and accrued liabilities
|
(2,505 | ) | 294 | |||||
Deferred revenue
|
(12,382 | ) | (1,979 | ) | ||||
Other liabilities
|
(25 | ) | (239 | ) | ||||
Net cash used in operating activities
|
(13,333 | ) | (32,510 | ) | ||||
Cash flows from investing activities:
|
||||||||
Net purchase of property and equipment
|
(2,253 | ) | (254 | ) | ||||
Net cash used in investing activities
|
(2,253 | ) | (254 | ) | ||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of long-term debt
|
20,102 | - | ||||||
Proceeds from issuance of common shares
|
9,910 | 25,456 | ||||||
Payment for modification of warrants
|
- | (4,500 | ) | |||||
Net cash provided by financing activities
|
30,012 | 20,956 | ||||||
Effect of exchange rate changes on cash
|
(573 | ) | - | |||||
Net increase in cash and cash equivalents
|
14,426 | (11,808 | ) | |||||
Cash and cash equivalents at the beginning of the period
|
37,304 | 23,909 | ||||||
Cash and cash equivalents at the end of the period
|
$ | 51,157 | $ | 12,101 | ||||
Supplemental Cash Flow Information:
|
||||||||
Cash paid for income taxes
|
$ | 15 | $ | 16 | ||||
Non-cash investing and financing activities:
|
||||||||
Discount on long-term debt
|
$ | (8,899 | ) | $ | - | |||
Issuance and extinguishment of warrant liabilities
|
$ | - | $ | 1,767 | ||||
Interest added to principal balance on Novartis note
|
$ | 170 | $ | 164 |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Net loss
|
$ | (8,130 | ) | $ | (15,580 | ) | $ | (14,466 | ) | $ | (37,365 | ) | ||||
Unrealized gain on available-for-sale securities
|
1 | - | 1 | - | ||||||||||||
Comprehensive loss
|
$ | (8,129 | ) | $ | (15,580 | ) | $ | (14,465 | ) | $ | (37,365 | ) |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Options for common shares
|
3,833 | 1,478 | 3,711 | 1,223 | ||||||||||||
Convertible preference shares
|
17 | 254 | 135 | 254 | ||||||||||||
Warrants for common shares
|
1,607 | 1,607 | 1,607 | 1,607 | ||||||||||||
Total
|
5,457 | 3,339 | 5,453 | 3,084 |
June 30, 2011
|
||||||||||||||||
Cost
Basis |
Unrealized
Gains
|
Unrealized
Losses
|
Estimated Fair
Value
|
|||||||||||||
Cash
|
$ | 15,548 | $ | - | $ | - | $ | 15,548 | ||||||||
Cash equivalents
|
35,608 | 1 | - | 35,609 | ||||||||||||
Total cash and cash equivalents
|
$ | 51,156 | $ | 1 | $ | - | $ | 51,157 |
December 31, 2010
|
||||||||||||||||
Cost
Basis |
Unrealized
Gains |
Unrealized
Losses
|
Estimated Fair
Value
|
|||||||||||||
Cash
|
$ | 29,536 | $ | - | $ | - | $ | 29,536 | ||||||||
Cash equivalents
|
7,768 | - | - | 7,768 | ||||||||||||
Total cash and cash equivalents
|
$ | 37,304 | $ | - | $ | - | $ | 37,304 |
June 30,
2011
|
December 31,
2010
|
|||||||
Trade receivables, net
|
$ | 8,257 | $ | 20,309 | ||||
Other receivables
|
2,802 | 555 | ||||||
Total
|
$ | 11,059 | $ | 20,864 |
June 30,
2011
|
December 31,
2010
|
|||||||
Furniture and equipment
|
$ | 32,827 | $ | 31,700 | ||||
Buildings, leasehold and building improvements
|
21,481 | 21,463 | ||||||
Construction-in-progress
|
943 | 203 | ||||||
Land
|
310 | 310 | ||||||
55,561 | 53,676 | |||||||
Less: Accumulated depreciation and amortization
|
(41,151 | ) | (38,807 | ) | ||||
Property and equipment, net
|
$ | 14,410 | $ | 14,869 |
June 30,
2011
|
December 31,
2010
|
|||||||
Accrued payroll and other benefits
|
$ | 2,709 | $ | 2,752 | ||||
Accrued management incentive compensation
|
2,253 | 4,982 | ||||||
Accrued professional fees
|
709 | 1,020 | ||||||
Accrued clinical trial costs
|
224 | 1,020 | ||||||
Other
|
1,192 | 884 | ||||||
Total
|
$ | 7,087 | $ | 10,658 |
·
|
Level 1: Quoted prices in active markets for identical assets or liabilities;
|
·
|
Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by readily observable market data for substantially the full term of the assets or liabilities; or
|
·
|
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
Fair Value Measurements at June 30, 2011 Using
|
||||||||||||||||
Quoted Prices in Active Markets for Identical Assets
|
Significant Other Observable Inputs
|
Significant Unobservable Inputs
|
||||||||||||||
(Level 1)
|
(Level 2)
|
(Level 3)
|
Total
|
|||||||||||||
Assets:
|
||||||||||||||||
Treasury Bond (1)
|
$ | 10,517 | $ | - | $ | - | $ | 10,517 | ||||||||
Money market funds (1)
|
25,092 | - | - | 25,092 | ||||||||||||
Foreign exchange options
|
- | 1,657 | - | 1,657 | ||||||||||||
Total
|
$ | 35,609 | $ | 1,657 | $ | - | $ | 37,266 | ||||||||
Liabilities:
|
||||||||||||||||
Warrant liabilities
|
$ | - | $ | - | $ | 1,395 | $ | 1,395 |
Fair Value Measurements at December 31, 2010 Using
|
||||||||||||||||
Quoted Prices in Active Markets for Identical Assets
|
Significant Other Observable Inputs
|
Significant Unobservable Inputs
|
||||||||||||||
(Level 1)
|
(Level 2)
|
(Level 3)
|
Total
|
|||||||||||||
Assets:
|
||||||||||||||||
Repurchase agreements (1)
|
$ | 1,428 | $ | - | $ | - | $ | 1,428 | ||||||||
Money market funds (1)
|
6,340 | - | - | 6,340 | ||||||||||||
Total
|
$ | 7,768 | $ | - | $ | - | $ | 7,768 | ||||||||
Liabilities:
|
||||||||||||||||
Warrant liabilities
|
$ | - | $ | - | $ | 4,245 | $ | 4,245 |
June 30,
2011
|
December 31,
2010
|
|||||||
Expected volatility
|
101.3 - 102.3 | % | 93.5 - 94.9 | % | ||||
Risk-free interest rate
|
0.8 | % | 2.0 | % | ||||
Expected term
|
3.5 - 3.6 years
|
3.9 - 4.1 years
|
Warrant Liabilities at
June 30, 2011
|
||||
Balance at December 31, 2010
|
$ | 4,245 | ||
Net decrease in fair value of warrant liabilities on revaluation
|
(2,850 | ) | ||
Balance at June 30, 2011
|
$ | 1,395 |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Interest expense
|
||||||||||||||||
Novartis note
|
$ | 85 | $ | 83 | $ | 169 | $ | 165 | ||||||||
Servier loan
|
538 | - | 980 | - | ||||||||||||
Other
|
11 | 7 | 17 | 12 | ||||||||||||
Total interest expense
|
$ | 634 | $ | 90 | $ | 1,166 | $ | 177 |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Research and development
|
$ | 885 | $ | 629 | $ | 1,946 | $ | 1,086 | ||||||||
Selling, general and administrative
|
1,399 | 490 | 2,110 | 995 | ||||||||||||
Total share-based compensation expense
|
$ | 2,284 | $ | 1,119 | $ | 4,056 | $ | 2,081 |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Dividend yield
|
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
Expected volatility
|
87 | % | 79 | % | 87 | % | 79 | % | ||||||||
Risk-free interest rate
|
1.76 | % | 1.80 | % | 1.87 | % | 2.52 | % | ||||||||
Expected term
|
5.6 years
|
5.6 years
|
5.3 years
|
5.6 years
|
Options
|
Weighted Average Exercise Price
|
Weighted Average Remaining Contractual Life
(in years)
|
Aggregate Intrinsic Value
(in thousands)
|
|||||||||||||
Options outstanding at December 31, 2010
|
2,331,450 | $ | 25.36 | 7.71 | $ | 99 | ||||||||||
Granted
|
1,806,040 | 5.24 | ||||||||||||||
Forfeited, expired or cancelled
|
(85,988 | ) | 51.89 | |||||||||||||
Options outstanding at June 30, 2011
|
4,051,502 | $ | 15.83 | 8.27 | $ | 1 | ||||||||||
Options exercisable at June 30, 2011
|
2,308,248 | $ | 22.33 | 7.63 | $ | - |
|
·
|
In December of 2010, we entered into an agreement with Servier to jointly develop and commercialize XOMA 052 in multiple indications, which provided for a non-refundable upfront payment of $15.0 million that we received in January of 2011. In connection with this agreement, Servier will fully fund the first $50.0 million of future XOMA 052 global clinical development and chemistry and manufacturing controls (“CMC”) expenses, and 50% of further expenses, for the Behcet's uveitis indication, which is expected to advance into Phase 3 development in 2011.
|
|
·
|
In January of 2011, we received the full €15.0 million advance allowed under our loan agreement with Servier dated December 30, 2010, converting to U.S. dollar proceeds of approximately $19.5 million.
|
|
·
|
In March of 2011, we announced that our Phase 2b trial of XOMA 052 in Type 2 diabetes in 421 patients did not achieve the primary endpoint of reduction in hemoglobin A1c (“HbA1c”) after six monthly treatments with XOMA 052 compared to placebo. Significant decreases were observed in C-reactive protein (“CRP”), a biomarker for the risk of heart attack, stroke and other cardiovascular diseases, in all dose groups versus placebo. In addition, significant improvements in high-density lipoprotein (“HDL”), or “good” cholesterol, were observed in two of four XOMA 052 dose groups versus placebo. XOMA 052 was well-tolerated in this trial, with no serious drug-related adverse events and a safety profile consistent with previous trials.
|
|
·
|
In June of 2011, we announced top line trial results from our six-month Phase 2a trial in 74 patients where XOMA 052 was shown to be well-tolerated with no significant differences in adverse events between XOMA 052 and placebo. Evidence of biological activity was observed including a reduction in CRP. There were no differences in glycemic control between the drug and placebo groups as measured by HbA1c levels.
|
|
·
|
In May of 2011, the National Institute of Allergy and Infectious Diseases (“NIAID”), part of the National Institutes of Health (“NIH”), informed us that it is initiating a Phase 1 trial of XOMA 3AB, a novel formulation of three antibodies designed to prevent and treat botulism poisoning. This double-blind, dose-escalation study in approximately 24 healthy volunteers is designed to assess the safety and tolerability, and determine the pharmacokinetic profile, of XOMA 3AB.
|
|
·
|
In June of 2011, we announced our discovery of two new classes of fully-human monoclonal antibodies, XMetA and XMetS, which activate or sensitize the insulin receptor in vivo, each representing a distinct new therapeutic approach to the treatment of patients with diabetes. Studies of XMetA demonstrated that it reduced fasting blood glucose levels and improved glucose tolerance in a mouse model of diabetes. After six weeks of treatment, there was a statically significant reduction in HbA1c levels, a standard measure of average blood glucose levels over time, in mice treated with XMetA compared to a control group, and there was a statistically significant reduction in elevated non-HDL cholesterol levels. Studies of XMetS showed enhanced insulin sensitivity and statistically significant improvements in fasting blood glucose levels and glucose tolerance in mice treated with XMetS as compared to a control group, and there was a statistically significant reduction in elevated non-HDL cholesterol levels. These data were presented at the American Diabetes Association’s 71st Scientific Sessions.
|
|
·
|
In the first half of 2011, we sold 821,386 common shares through Wm Smith & Co. (“Wm Smith”) and McNicoll, Lewis & Vlak LLC (“MLV”) under our At Market Issuance Sales Agreement dated October 26, 2010 (the “2010 ATM Agreement”), for aggregate gross proceeds of $4.4 million, and 2,398,017 common shares through MLV under our At Market Issuance Sales Agreement dated February 4, 2011 (the “2011 ATM Agreement”), for aggregate gross proceeds of $5.9 million, of which $3.7 million of cash was received in June of 2011 with the remaining $2.2 million of cash received in July of 2011.
|
|
·
|
In April of 2011, the 2,959 Series B convertible preference shares previously issued to Genentech, Inc. were converted by Genentech into 254,560 common shares, and the associated liquidation preference of $29.6 million was eliminated.
|
|
·
|
In May of 2011, we entered into two foreign exchange options contracts in order to manage our foreign currency exposure relating to principal and interest payments on our €15.0 million loan from Servier. Upfront premiums paid on these contracts totaled $1.5 million.
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
License and collaborative fees
|
$ | 6,039 | $ | 150 | $ | 11,866 | $ | 339 | ||||||||
Contract and other revenue
|
10,467 | 5,481 | 20,128 | 12,292 | ||||||||||||
Royalties
|
19 | 311 | 126 | 513 | ||||||||||||
Total revenues
|
$ | 16,525 | $ | 5,942 | $ | 32,120 | $ | 13,144 |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||||||||||
2011
|
2010
|
Increase (Decrease)
|
2011
|
2010
|
Increase (Decrease)
|
|||||||||||||||||||
NIAID
|
$ | 5,368 | $ | 4,783 | $ | 585 | $ | 12,252 | $ | 8,294 | $ | 3,958 | ||||||||||||
Servier
|
4,592 | - | 4,592 | 6,674 | - | 6,674 | ||||||||||||||||||
Takeda
|
296 | 266 | 30 | 584 | 3,026 | (2,442 | ) | |||||||||||||||||
Other
|
211 | 432 | (221 | ) | 618 | 972 | (354 | ) | ||||||||||||||||
Total revenues
|
$ | 10,467 | $ | 5,481 | $ | 4,986 | $ | 20,128 | $ | 12,292 | $ | 7,836 |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Earlier stage programs
|
$ | 13,348 | $ | 12,566 | $ | 26,305 | $ | 23,740 | ||||||||
Later stage programs
|
4,933 | 6,780 | 9,323 | 13,193 | ||||||||||||
Total
|
$ | 18,281 | $ | 19,346 | $ | 35,628 | $ | 36,933 |
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Internal projects
|
$ | 12,051 | $ | 14,838 | $ | 20,937 | $ | 28,524 | ||||||||
Collaborative and contract arrangements
|
6,230 | 4,508 | 14,691 | 8,409 | ||||||||||||
Total
|
$ | 18,281 | $ | 19,346 | $ | 35,628 | $ | 36,933 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||
2011
|
2010 |
Increase
(Decrease)
|
2011 | 2010 |
Increase
(Decrease)
|
|||||||||||||||||||
Other income (expense)
|
||||||||||||||||||||||||
Gain on warrant revaluation
|
$ | 459 | $ | 2,951 | $ | (2,492 | ) | $ | 2,850 | $ | 1,691 | $ | 1,159 | |||||||||||
Unrealized foreign exchange loss (1)
|
(257 | ) | - | (257 | ) | (1,874 | ) | - | (1,874 | ) | ||||||||||||||
Realized foreign exchange gain (2)
|
(4 | ) | (1 | ) | (3 | ) | 556 | (2 | ) | 558 | ||||||||||||||
Unrealized gain on foreign exchange options
|
157 | - | 157 | 157 | - | 157 | ||||||||||||||||||
Warrant modification expense
|
- | - | - | - | (4,500 | ) | 4,500 | |||||||||||||||||
Other
|
- | - | - | (11 | ) | (2 | ) | (9 | ) | |||||||||||||||
Total other income (expense)
|
$ | 355 | $ | 2,950 | $ | (2,595 | ) | $ | 1,678 | $ | (2,813 | ) | $ | 4,491 |
(1)
|
Unrealized foreign exchange loss for the three and six months ended June 30, 2011 primarily relates to losses on the re-measurement of the €15 million Servier loan.
|
(2)
|
Realized foreign exchange gain for the six months ended June 30, 2011 primarily relates to the conversion into U.S. dollars of the €15 million cash proceeds received from Servier in January of 2011. |
Maturity
|
Carrying Amount
(in thousands)
|
Fair Value
(in thousands)
|
Average Interest Rate
|
||||||||||
June 30, 2011
|
|||||||||||||
Cash and cash equivalents
|
Daily to 90 days
|
$ | 51,156 | $ | 51,157 | 0.10 | % | ||||||
December 31, 2010
|
|||||||||||||
Cash and cash equivalents
|
Daily to 90 days
|
$ | 37,304 | $ | 37,304 | 0.09 | % |
·
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research and development relating to our product candidates and production technologies,
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·
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various human clinical trials, and
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·
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protection of our intellectual property.
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·
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operations will generate meaningful funds,
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·
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additional agreements for product development funding can be reached,
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·
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strategic alliances can be negotiated, or
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·
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adequate additional financing will be available for us to finance our own development on acceptable terms, or at all.
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·
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results of preclinical studies and clinical trials,
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·
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information relating to the safety or efficacy of products or product candidates,
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·
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developments regarding regulatory filings,
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·
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announcements of new collaborations,
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·
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failure to enter into collaborations,
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·
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developments in existing collaborations,
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·
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our funding requirements and the terms of our financing arrangements,
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·
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technological innovations or new indications for our therapeutic products and product candidates,
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·
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introduction of new products or technologies by us or our competitors,
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sales and estimated or forecasted sales of products for which we receive royalties, if any,
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·
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government regulations,
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·
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developments in patent or other proprietary rights,
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·
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the number of shares issued and outstanding,
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·
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the number of shares trading on an average trading day,
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·
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announcements regarding other participants in the biotechnology and pharmaceutical industries, and
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·
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market speculation regarding any of the foregoing.
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·
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our future filings will be delayed,
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·
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our preclinical and clinical studies will be successful,
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we will be successful in generating viable product candidates to targets,
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·
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we will be able to provide necessary additional data,
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results of future clinical trials will justify further development, or
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we will ultimately achieve regulatory approval for any of these product candidates.
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·
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testing,
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·
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manufacturing,
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promotion and marketing, and
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·
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exporting.
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·
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In April of 1996, we entered into an agreement with Genentech whereby we agreed to co-develop Genentech’s humanized monoclonal antibody product RAPTIVA®. In April of 1999, March of 2003, and January of 2005, the companies amended the agreement. In October of 2003, RAPTIVA® was approved by the FDA for the treatment of adults with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and, in September of 2004, Merck Serono announced the product’s approval in the European Union. In January of 2005, we entered into a restructuring of our collaboration agreement with Genentech which ended our existing cost and profit sharing arrangement related to RAPTIVA® in the United States and entitled us to a royalty interest on worldwide net sales. In February of 2009, the EMA announced that it had recommended suspension of the marketing authorization of RAPTIVA® in the European Union and EMD Serono announced that, in consultation with Health Canada, it would suspend marketing of RAPTIVA® in Canada. In March of 2009, Merck Serono Australia, following a recommendation from the TGA, announced that it was withdrawing RAPTIVA® from the Australian market. In the second quarter of 2009, Genentech announced and carried out a phased voluntary withdrawal of RAPTIVA® from the U.S. market, based on the association of RAPTIVA® with an increased risk of PML. As a result, sales of RAPTIVA® ceased in the second quarter of 2009.
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·
|
In March of 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 of 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 of 2005, we announced the initiation of the second clinical trial of HCD122 in patients with multiple myeloma. In November of 2008, we announced the restructuring of this product development collaboration, which involves six development programs including the ongoing HCD122 and LFA102 programs. In exchange for cash and debt reduction on our existing loan facility with Novartis, Novartis has control over the HCD122 and LFA102 programs and the additional ongoing program, as well as the right to expand the development of these programs into additional indications outside of oncology.
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|
·
|
In March of 2005, we entered into a contract with the National Institute of Allergy and Infectious Diseases (“NIAID”) to produce three monoclonal antibodies designed to protect United States citizens against the harmful effects of botulinum neurotoxin used in bioterrorism. In July of 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 of 2008, we announced that we were awarded an additional contract with NIAID to support our on-going development of drug candidates toward clinical trials in the treatment of botulism poisoning.
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|
·
|
In December of 2010, we entered into a license and collaboration agreement with Servier, to jointly develop and commercialize XOMA 052 in multiple indications. Under the terms of the agreement, Servier has worldwide rights to diabetes and cardiovascular disease indications and rights outside the U.S. and Japan to Behcet’s uveitis and other inflammatory and oncology indications. We retain development and commercialization rights for Behcet's uveitis and other inflammatory disease and oncology indications in the U.S. and Japan, and has an option to reacquire rights to diabetes and cardiovascular disease indications from Servier in these territories. Should we exercise this option, we will be required to pay Servier an option fee and partially reimburse their incurred development expenses. The agreement contains customary termination rights relating to matters such as material breach by either party, safety issues and patents. Servier also has a unilateral right to terminate the agreement on a country-by-country basis or in its entirety on six months’ notice.
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|
·
|
In December of 2010, we also entered into a loan agreement with Servier, which provides for an advance of up to €15.0 million and was fully funded in January of 2011 with the proceeds converting to approximately $19.5 million using the January 13, 2011 Euro to USD exchange rate. This loan is secured by an interest in our intellectual property rights to all XOMA 052 indications worldwide, excluding the U.S. 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 (i) 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 (ii) using a significant percentage of any upfront, milestone or royalty payments we receive from any third party collaboration or development partner for rights to XOMA 052 in the U.S. and/or Japan. In addition, the loan becomes immediately due and payable upon certain customary events of default. At June 30, 2011, the €15.0 million outstanding principal balance under this loan agreement would have equaled approximately $21.6 million using the June 30, 2011 Euro to USD exchange rate.
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|
·
|
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 50 companies. As of June 30, 2011, 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.
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|
·
|
In September of 2004, we entered into a collaboration arrangement with Aphton Corporation (“Aphton”) for the treatment of gastrointestinal and other gastrin-sensitive cancers using anti-gastrin monoclonal antibodies. In January of 2006, Aphton announced that its common stock had been delisted from NASDAQ. In May of 2006, Aphton filed for bankruptcy protection under Chapter 11, Title 11 of the United States Bankruptcy Code.
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·
|
In September of 2006, we entered into an agreement with Taligen Therapeutics, Inc. (“Taligen”) which formalized an earlier letter agreement, which was signed in May of 2006, for the development and cGMP manufacture of a novel antibody fragment for the potential treatment of inflammatory diseases. In May of 2007, we and Taligen entered into a letter agreement which provided that we would not produce a cGMP batch at clinical scale pursuant to the terms of the agreement entered into in September of 2006. In addition, the letter agreement provided that we would conduct and complete the technical transfer of the process to Avecia Biologics Limited or its designated affiliate (“Avecia”). The letter agreement also provided that, subject to payment by Taligen of approximately $1.7 million, we would grant to Avecia a non-exclusive, worldwide, paid-up, non-transferable, non-sublicensable, perpetual license under our owned project innovations. We received $0.6 million as the first installment under the payment terms of the letter agreement but not the two additional payments totaling approximately $1.1 million to which we were entitled upon fulfillment of certain obligations. In May of 2009, the matter was resolved by agreement of the parties in a manner that had no further impact on our financial position.
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|
·
|
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
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|
·
|
extensive experience in preclinical testing and human clinical trials.
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·
|
In June of 2009, Novartis announced it had received U.S. marketing approval for Ilaris® (canakinumab), a fully-human monoclonal antibody targeting IL-1 beta, to treat children and adults with Cryopyrin-Associated Periodic Syndromes (“CAPS”). In October of 2009, Novartis announced that Ilaris® had been approved in the European Union for CAPS. Canakinumab is also in clinical trials for cardiovascular risk reduction, and in Type 2 diabetes, certain forms of gout and systemic juvenile rheumatoid arthritis, among other conditions. In January of 2011, Novartis announced that it had filed for EMA approval of Ilaris® for the treatment and prevention of gout. In June of 2011, Novartis announced that an advisory committee of the FDA voted in favor of the overall efficacy but not the overall safety of canakinumab to treat gouty arthritis attacks in patients who cannot obtain adequate relief with non-steroidal anti-inflammatory drugs or colchicine.
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·
|
Eli Lilly and Company (“Lilly”) is developing LY2189102, an investigational IL-1 beta antibody, for subcutaneous injection for the treatment of Type 2 diabetes. In June of 2011, Lily disclosed at a scientific conference that, in a double-blind, placebo controlled Phase 2 study of 106 patients with Type 2 diabetes, a significant (p<0.05), early reduction in C reactive protein occurred, HbA1c was moderately reduced and anti-inflammatory effects were shown.
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|
·
|
In 2008, Biovitrum AB (now called Swedish Orphan Biovitrum, “Biovitrum”) obtained a worldwide exclusive license to Amgen Inc.’s (“Amgen”) Kineret® (anakinra) for its current approved indication. Kineret® is an IL-1 receptor antagonist (IL-1ra) currently marketed to treat rheumatoid arthritis and has been evaluated over the years in multiple IL-1 mediated diseases, including Type 2 diabetes and other indications we are considering for XOMA 052. 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 of 2010, Biovitrum announced that the FDA had granted orphan drug designation to Kineret® for the treatment of CAPS.
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·
|
In February of 2008, Regeneron Pharmaceuticals, Inc. (“Regeneron”) announced it had received marketing approval from the FDA for ARCALYST® (rilonacept) Injection for Subcutaneous Use, an interleukin-1 blocker or IL-1 Trap, for the treatment of CAPS, including Familial Cold Auto-inflammatory Syndrome and Muckle-Wells Syndrome in adults and children 12 and older. In September of 2009, Regeneron announced that rilonacept was approved in the European Union for CAPS. In June of 2010 and February of 2011, Regeneron announced positive results of two Phase 3 clinical trials of rilonacept in gout. In March of 2011, Regeneron disclosed that it intends to file a supplemental BLA for ARCALYST® for the prevention and treatment of gout.
|
|
·
|
Amgen has been developing AMG 108, a fully-human monoclonal antibody that targets inhibition of the action of IL-1. In April of 2008, Amgen discussed results from its recently completed 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 of 2011, MedImmune, the worldwide biologics unit for AstraZeneca PLC, announced that Amgen granted it rights to develop AMG 108 worldwide except in Japan.
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·
|
In June of 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 2010, this study was extended to include two additional groups of patients.
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|
·
|
In May of 2006, the U.S. Department of Health & Human Services (“DHHS”) awarded Cangene Corporation (“Cangene”) a five-year, $362.0 million contract under Project Bioshield. The contract requires Cangene to manufacture and supply 200,000 doses of an equine heptavalent botulism anti-toxin to treat individuals who have been exposed to the toxins that cause botulism. In May of 2008, Cangene announced significant product delivery under this contract. In March of 2010, this contract was extended for an additional two years, until May of 2013. In June of 2011, Cangene announced that DHHS will exercise options under the supply contract which are expected to increase the total contract to $423.0 million and to extend the delivery schedule to 2018.
|
|
·
|
Emergent BioSolutions, Inc. (“Emergent”) is currently in development of a botulism immunoglobulin candidate that may compete with our anti-botulinum neurotoxin monoclonal antibodies.
|
|
·
|
We are aware of additional companies that are pursuing biodefense-related antibody products. PharmAthene, Inc. and Human Genome Sciences, Inc. are developing anti-anthrax antibodies. Cangene and Emergent are developing anti-anthrax immune globulin products. These products may compete with our efforts in the areas of other monoclonal antibody-based biodefense products and the manufacture of antibodies to supply strategic national stockpiles.
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·
|
imposition of government controls,
|
|
·
|
export license requirements,
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|
·
|
political or economic instability,
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·
|
trade restrictions,
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·
|
changes in tariffs,
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·
|
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.
|
|
·
|
“blacklisting” of our common shares by certain pension funds,
|
|
·
|
legislation restricting certain types of transactions, and
|
|
·
|
punitive tax legislation.
|
|
·
|
require certain procedures to be followed and time periods to be met for any shareholder to propose matters to be considered at annual meetings of shareholders, including nominating directors for election at those meetings;
|
|
·
|
authorize our Board of Directors to issue up to 1,000,000 preference shares without shareholder approval and to set the rights, preferences and other designations, including voting rights, of those shares as the Board of Directors may determine; and
|
|
·
|
contain provisions, similar to those contained in the Delaware General Corporation Law that may make business combinations with interested shareholders more difficult.
|
Exhibit Number
|
||
Foreign Exchange and Options Master Agreement (FEOMA) dated as of May 16, 2011 between Royal Bank of Canada and XOMA Ltd., with letter agreement dated May 17, 2011
|
||
Certification of Steven B. Engle, filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
||
Certification of Fred Kurland, filed pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
||
Certification of Steven B. Engle, furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
||
Certification of Fred Kurland, furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
||
Press Release dated August 4, 2011, furnished herewith
|
||
101.INS | XBRL Instance Document | |
101.SCH | XBRL Schema Document | |
101.CAL | XBRL Calculation Linkbase Document | |
101.LAB | XBRL Label Linkbase Document | |
101.PRE | XBRL Presentation Linkbase Document | |
101.DEF | XBRL Definition Linkbase Document |
|
XOMA Ltd.
|
|
Date: August 4, 2011
|
By:
|
/s/ STEVEN B. ENGLE
|
|
Steven B. Engle
|
|
Chairman, Chief Executive Officer and President
|
||
(principal executive officer)
|
||
Date: August 4, 2011
|
By:
|
/s/ FRED KURLAND
|
|
Fred Kurland
|
|
Vice President, Finance and Chief Financial Officer
|
||
(principal financial officer and chief accounting officer)
|
1.
|
Definitions
|
1 |
2.
|
FX Transactions and Options
|
11 |
2.1
|
Scope of the Agreement
|
11 |
2.2
|
Single Agreement
|
12 |
2.3
|
Confirmations
|
12 |
2.4
|
Inconsistencies
|
12 |
3.
|
Option Premium
|
12 |
3.1
|
Payment of Premium
|
12 |
3.2
|
Late Payment or Non-Payment of Premium
|
13 |
4.
|
Discharge and Termination of Options; Netting of Option Premiums
|
13 |
4.1
|
Discharge and Termination
|
13 |
4.2
|
Netting of Option Premiums
|
14 |
5.
|
Exercise and Settlement of Options
|
14 |
5.1
|
Exercise of Options
|
14 |
5.2
|
No Partial Exercise
|
15 |
5.3
|
Automatic Exercise
|
15 |
5.4
|
Settlement of Exercised Options
|
15 |
5.5
|
Settlement at In-the-Money Amount
|
16 |
6.
|
Settlement and Netting of FX Transactions
|
16 |
6.1
|
Settlement of FX Transactions
|
16 |
6.2
|
Settlement Netting
|
16 |
6.3
|
Novation Netting
|
16 |
6.4
|
General
|
17 |
7.
|
Representations. Warranties and Covenants
|
17 |
7.1
|
Representations and Warranties
|
17 |
7.2
|
Covenants
|
18 |
8.
|
Close-out and Liquidation
|
18 |
8.1
|
Manner of Close-Out and Liquidation
|
18 |
8.2.
|
Set-Off Against Credit Support
|
22 |
8.3
|
Other Foreign Exchange Transactions and Currency Options
|
22 |
8.4
|
Payment and Late Interest
|
23 |
8.5
|
Suspension of Obligations
|
23 |
8.6
|
Expenses
|
23 |
8.7
|
Reasonable Pre-Estimate
|
24 |
8.8
|
No Limitation of Other Rights; Set-Off
|
24 |
9.
|
Force Majeure, Act of State, Illegality and Impossibility
|
24 |
9.1
|
Force Majeure, Act of State, Illegality and Impossibility
|
24 |
9.2
|
Transfer to Avoid Force Majeure, Act of State, Illegality or Impossibility
|
25 |
10.
|
Parties to Rely on Their Own Expertise
|
25 |
11.
|
Miscellaneous
|
26 |
11.1
|
Currency Indemnity
|
26 |
11.2
|
Assignment
|
26 |
11.3
|
Telephonic Recording
|
27 |
11.4
|
Notices
|
27 |
11.5
|
Termination
|
27 |
11.6
|
Severability
|
27 |
11.7
|
No Waiver
|
27 |
11.8
|
Master Agreement
|
27 |
11.9
|
Time of Essence, Etc
|
28 |
11.10
|
Headings
|
28 |
11.11
|
Payments Generally
|
28 |
11.12
|
Amendments
|
28 |
11.13
|
Credit Support
|
28 |
11.14
|
Adequate Assurances
|
28 |
11.15
|
Correction of Confirmations
|
29 |
12.
|
Law and Jurisdiction
|
29 |
12.1
|
Governing Law
|
29 |
12.2
|
Consent to Jurisdiction
|
29 |
12.3
|
Waiver of Jury Trial
|
29 |
Waiver of Immunities
|
29 | |
Schedule | i |
MASTER AGREEMENT dated as of May 16 , 2011 , by and between Royal Bank of Canada ,a federally chartered canadian bank , and XOMA Ltd , a Bermuda company . |
|
(i)
|
the Parties thereto and the Designated Offices through which they are respectively acting,
|
|
(ii)
|
the amounts of the Currencies being bought or sold and by which Party,
|
|
(iii)
|
the Value Date, and
|
|
(iv)
|
any other term generally included in such a writing in accordance with the practice of the relevant foreign exchange market; and
|
|
(i)
|
the Parties thereto and the Designated Offices through which they are respectively acting,
|
|
(ii)
|
whether the Option is a Call or a Put,
|
|
(iii)
|
the Call Currency and the Put Currency that are the subject of the Option and their respective quantities,
|
|
(iv)
|
which Party is the Seller and which is the Buyer,
|
|
(v)
|
the Strike Price,
|
|
(vi)
|
the Premium and the Premium Payment Date,
|
|
(vii)
|
the Expiration Date,
|
|
(viii)
|
the Expiration Time,
|
|
(ix)
|
whether the Option is an American Style Option or a European Style Option, and
|
|
(x)
|
such other matters, if any, as the Parties may agree.
|
SECTION 2.
|
FX TRANSACTIONS AND OPTIONS
|
SECTION 3.
|
OPTION PREMIUM
|
SECTION 4.
|
DISCHARGE AND TERMINATION OF OPTIONS: NETTING OF OPTION PREMIUMS
|
(i)
|
each being with respect to the same Put Currency and the same Call Currency;
|
(ii)
|
each having the same Expiration Date and Expiration Time;
|
(iii)
|
each being of the same style, i.e. either both being American Style Options or both being European Style Options;
|
(iv)
|
each having the same Strike Price;
|
(v)
|
each being transacted by the same pair of Designated Offices of Buyer and Seller; and
|
(vi)
|
neither of which shall have been exercised by delivery of a Notice of Exercise:
|
SECTION 5.
|
EXERCISE AND SETTLEMENT OF OPTIONS
|
SECTION 6.
|
SETTLEMENT AND NETTING OF FX TRANSACTIONS
|
SECTION 7.
|
REPRESEN TATION'S. WARRANTIES AND COVENANTS
|
SECTION 8.
|
CLOSE-OUT AND LIQUIDATION
|
(i)
|
Calculating Closing Gain or Loss. The Non-Defaulting Party shall calculate in good faith, with respect to each such terminated Currency Obligation, except to the extent that in the good faith opinion of the Non-Defaulting Party certain of such Currency Obligations may not be liquidated as provided herein under applicable law, as of the Close-Out Date or as soon thereafter as reasonably practicable, the Closing Gain. or. as appropriate, the Closing Loss, as follows:
|
(A)
|
for each Currency Obligation calculate a "Close-Out Amount" as follows:
|
(1)
|
in the case of a Currency Obligation whose Value Date is the same as or is later than the Close-Out Date, the amount of such Currency Obligation; or
|
(2)
|
in the case of a Currency Obligation whose Value Date precedes the Close-Out Date, the amount of such Currency Obligation increased, to the extent permitted by applicable law, by adding interest thereto from and including the Value Date to but excluding the Close-Out Date at overnight LIBOR; and
|
(3)
|
for each such amount in a Currency other than the Non-Defaulting
|
(B)
|
determine in relation to each Value Date: (1) the sum of all Close-Out Amounts relating to Currency Obligations under which the Non-Defaulting Party would otherwise have been entitled to receive the relevant amount on that Value Date; and (2) the sum of all Close-Out Amounts relating to Currency Obligations under which the Non-Defaulting Party would otherwise have been obliged to deliver the relevant amount to the Defaulting Party on that Value Date; and
|
(C)
|
if the sum determined under (B)(1) is greater than the sum determined under (B)(2), the difference shall be the Closing Gain for such Value Date; if the sum determined under (B)(1) is less than the sum determined under (B)(2), the difference shall be the Closing Loss for such Value Date.
|
(ii)
|
Determining Present Value. To the extent permitted by applicable law, the Non- Defaulting Party shall adjust the Closing Gain or Closing Loss for each Value Date falling after the Close-Out Date to present value by discounting the Closing Gain or Closing Loss from and including the Value Date to but excluding the Close-Out Date, at LIBOR with respect to the Non-Defaulting Party's Base Currency as at the Close-Out Date or at such other rate as may be prescribed by applicable law.
|
(iii)
|
Netting. The Non-Defaulting Party shall aggregate the following amounts so that all such amounts are netted into a single liquidated amount payable to or by the Non- Defaulting Party: (x) the sum of the Closing Gains for all Value Dates (discounted to present value, where appropriate, in accordance with the provisions of Section 8.1(b)(ii)) (which for the purposes of the aggregation shall be a positive figure); and (y) the sum of the Closing Losses for all Value Dates (discounted to present value, where appropriate, in accordance with the provisions of Section 8.1(b)(ii)) (which for the purposes of the aggregation shall be a negative figure).
|
(i)
|
Calculating Settlement Amount. Calculate in good faith with respect to each such terminated Option, except to the extent that in the good faith opinion of the Non- Defaulting Party certain of such Options may not be liquidated as provided herein under applicable law, as of the Close-Out Date or as soon as reasonably practicable thereafter a settlement amount for each Party equal to the aggregate of:
|
(A)
|
with respect to each Option purchased by such Party, and which the other Party has not elected to treat as void pursuant to Section 3.2(ii) for lack of payment of the Premium, the current market premium for such Option;
|
(B)
|
with respect to each Option sold by such Party and which such Party has not elected to treat as void pursuant to Section 3.2(ii) for lack of payment of the Premium, any unpaid Premium, provided that, if the Close-Out Date occurs before the Premium Payment Date, such amount shall be discounted from and including the Premium Payment Date to but excluding the Close-Out Date at a rate equal to LIBOR on the Close-Out Date and, if the Close-Out Date occurs after the Premium Payment Date, to the extent permitted by applicable law, the settlement amount shall include interest on any unpaid Premium from and including the Premium Payment Date to but excluding the Close-Out Date in the same Currency as such Premium at overnight LIBOR;
|
(C)
|
with respect to any exercised Option to be settled at its In-the-Money Amount (whether or not the Close-Out Date occurs before the Settlement Date for such Option), any unpaid amount due to such Party in settlement of such Option and, if the Close-Out Date occurs after the Settlement Date for such Option, to the extent permitted by applicable law, interest thereon from and including the applicable Settlement Date to but excluding the Close-Out Dale at overnight LIBOR; and
|
(D)
|
without duplication, the amount that the Non-Defaulting Party reasonably determines in good faith, as of the Close-Out Date or as of the earliest date thereafter that is reasonably practicable, to be its additional losses, costs and expenses in connection with such terminated Option, for the loss of its bargain, its cost of funding, or the loss incurred as a result of terminating, liquidating, obtaining or re-establishing a delta hedge or related trading position with respect to such Option;
|
(ii)
|
Converting to Base Currency. Convert any settlement amount calculated in accordance with clause (i) above in a Currency other than the Non-Defaulting Party's Base Currency into such Base Currency at the Spot Price at which, at the time of the calculation, the Non-Defaulting Party could enter into a contract in the foreign exchange market to buy the Non-Defaulting Party's Base Currency in exchange for such Currency (or, if such Spot Price is not available, conversion shall be accomplished by the Non-Defaulting Party using any commercially reasonable method); and
|
(iii)
|
Netting. Net such settlement amounts with respect to each Party so that all such amounts are netted to a single liquidated amount payable by one Party to the other Party.
|
SECTION 9.
|
FORCE MAJEURE. ACT OF STATE. ILLEGALITY AND IMPOSSIBILITY
|
SECTION 10.
|
PAR TIES TO RELY ON THEIR OWN EXPERTISE
|
SECTION 11.
|
MISCELLANEOUS
|
SECTION 12.
|
LAW AND JURISDICTION
|
Royal Bank of Canada | |||
By | /s/ IRENE KLAUSMANN | ||
Name: | IRENE KLAUSMANN | ||
Title: | AUTHORIZED SIGNATORY |
XOMA Ltd. | |||
By | /s/ Christopher J. Margolin | ||
Name: | Christopher J. Margolin | ||
Title: | Vice President, General Counsel and Secretary |
Contract No.:
Transaction Date:
Qpenlng'Closing Trade:
Buyer:
Seller:
Style:
Type of Option:
Call Currency and amount:
Put Currency and amount:
Strike Price:
Expiration Date:
Expiration Tims:
Settlement Date:
Broker:
Option Buyers Premium Payment:
Premium Payment Date:
|
647781
May 17, 2011
OPENING
XOMA LTD.
ROYAL BANK OF CANADA
EUROPEAN
CALL
15,000,000.00EUR
22,650,000.00USD
1.510Q
January 11, 2016
10:00AM New York Time
January 13, 2016
DIRECT
1,370,000.00USD
May 19, 2011
|
(a)
|
The office of ths Buyer for the currency Option Transaction Is: |
BERKELEY
|
(b)
|
The office of the Se11er for tho Currency Option Transaction is: |
TORONTO
|
ROYAL BANK OF CANADA
|
Confirmed as of the date first written: XOMA LTD.
|
|
/s/ Erica Lei | /s/ Tom Burns | |
Erica Lei | Name: Tom Burns | |
Foreign Exchange Derivative Operations | Title: Director, FP&A | |
Name: | ||
Title: | ||
1.
|
I have reviewed this quarterly report on Form 10-Q of XOMA Ltd.;
|
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 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.
|
Date: August 4, 2011
|
/s/ STEVEN B. ENGLE
|
Steven B. Engle
|
|
Chairman, Chief Executive Officer and President
|
|
(principal executive officer)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of XOMA Ltd.;
|
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 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.
|
Date: August 4, 2011
|
/s/ FRED KURLAND
|
Fred Kurland
|
|
Vice President, Finance and Chief Financial Officer
|
|
(principal financial officer)
|
Date: August 4, 2011
|
/s/ STEVEN B. ENGLE
|
Steven B. Engle
|
|
Chairman, Chief Executive Officer and President
|
|
(principal executive officer)
|
Date: August 4, 2011
|
/s/ FRED KURLAND
|
Fred Kurland
|
|
Vice President, Finance and Chief Financial Officer
|
|
(principal financial officer)
|
|
·
|
XOMA 3AB Phase 1 trial initiated by NIAID: The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, initiated a Phase 1 trial of XOMA 3AB, a novel formulation of three antibodies designed to prevent and treat botulism poisoning, among the most deadly bioterror threats. This double-blind, dose-escalation study in approximately 24 healthy volunteers, is designed to assess the safety and tolerability and determine the pharmacokinetic profile of XOMA 3AB. More information is available at http://www.clinicaltrials.gov/ct2/show/NCT01357213?term=XOMA+3AB&rank=1
|
|
·
|
Discovery of two new classes of insulin receptor-regulating antibodies reported at American Diabetes Association 71st Scientific Sessions: Insulin is the key metabolic hormone for regulating blood sugar and exerts its action on cells by signaling through the insulin receptor. Insulin receptor-activating antibodies such as XOMA's XMetA antibody are designed to provide long-acting insulin-like activity to diabetic patients who cannot make sufficient insulin, potentially reducing the number of insulin injections needed to control their blood glucose levels. In contrast, insulin receptor-sensitizing antibodies such as XOMA's XMetS are designed to reduce insulin resistance and could enable diabetes patients to more effectively use their own insulin to control blood glucose levels.
|
|
·
|
New U.S. patent issued covering XOMA 052 use in certain interleukin-1 beta-related coronary conditions: On August 2, the U.S. Patent and Trademark Office issued XOMA a new patent covering methods of treating certain coronary conditions including myocardial infarction, or heart attack, using XOMA 052 and interleukin-1 beta antibodies with similar binding properties. This is the tenth U.S. patent from the XOMA 052 program to have been issued, in addition to numerous pending applications and granted patents outside of the United States.
|
|
·
|
Six month top line results from 74 patient XOMA 052 Phase 2a trial support safety and biological activity: XOMA 052 was well tolerated with no significant differences between the XOMA 052 and placebo groups in observations of adverse events. XOMA 052 continued to show evidence of biological activity as shown by a reduction in levels of C-reactive protein, a biomarker of cardiovascular risk. There were no differences in glycemic control between the drug groups and placebo as measured by hemoglobin A1c levels. This Phase 2a trial was designed as an exploratory trial focused on overall safety and kinetics and was not designed to show statistically significant differences in measures of biological activity. The results were as expected based on data from the Phase 2a three-month interim review and the 421 patient Phase 2b trial.
|
|
·
|
XOMA 052, a potentially best-in-class antibody that binds to the inflammatory cytokine interleukin-1 beta, or IL-1 beta. Les Laboratoires Servier is XOMA’s development and commercialization partner for XOMA 052. XOMA and Servier plan to enter XOMA 052 into Phase 3 clinical development for Behcet’s uveitis, an orphan indication, and Phase 2 development for cardiovascular disease.
|
|
·
|
XOMA 3AB, a novel combination of three antibodies in one product under development to prevent and treat botulism poisoning caused by exposure to botulinum neurotoxin Type A, among the most deadly bioterror threats. XOMA 3AB is in a Phase 1 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). XOMA receives funding for development of XOMA 3AB under NIAID Contract # HHSN266200600008C.
|
|
·
|
A preclinical pipeline with candidates in development for autoimmune, cardio-metabolic, inflammatory and oncologic diseases.
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Revenues:
|
||||||||||||||||
License and collaborative fees
|
$ | 6,039 | $ | 150 | $ | 11,866 | $ | 339 | ||||||||
Contract and other revenue
|
10,467 | 5,481 | 20,128 | 12,292 | ||||||||||||
Royalties
|
19 | 311 | 126 | 513 | ||||||||||||
Total revenues
|
16,525 | 5,942 | 32,120 | 13,144 | ||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
18,281 | 19,346 | 35,628 | 36,933 | ||||||||||||
Selling, general and administrative
|
6,113 | 5,026 | 11,483 | 10,579 | ||||||||||||
Total operating expenses
|
24,394 | 24,372 | 47,111 | 47,512 | ||||||||||||
Loss from operations
|
(7,869 | ) | (18,430 | ) | (14,991 | ) | (34,368 | ) | ||||||||
Other income (expense):
|
||||||||||||||||
Investment and interest income
|
18 | 6 | 28 | 9 | ||||||||||||
Interest expense
|
(634 | ) | (90 | ) | (1,166 | ) | (177 | ) | ||||||||
Other income (expense)
|
355 | 2,950 | 1,678 | (2,813 | ) | |||||||||||
Net loss before taxes
|
(8,130 | ) | (15,564 | ) | (14,451 | ) | (37,349 | ) | ||||||||
Provision for income tax expense
|
- | (16 | ) | (15 | ) | (16 | ) | |||||||||
Net loss
|
$ | (8,130 | ) | $ | (15,548 | ) | $ | (14,436 | ) | $ | (37,333 | ) | ||||
Basic and diluted net loss per common share
|
$ | (0.27 | ) | $ | (0.93 | ) | $ | (0.49 | ) | $ | (2.24 | ) | ||||
Shares used in computing basic and diluted net loss per common share
|
29,889 | 16,695 | 29,536 | 16,695 |
June 30, 2011
|
December 31, 2010
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
$ | 51,157 | $ | 37,304 | |||||
Trade and other receivables, net
|
11,059 | 20,864 | ||||||
Prepaid expenses and other current assets
|
807 | 712 | ||||||
Total current assets
|
63,023 | 58,880 | ||||||
Property and equipment, net
|
14,410 | 14,869 | ||||||
Other assets
|
2,165 | 503 | ||||||
Total assets
|
$ | 79,598 | $ | 74,252 | ||||
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$ | 5,043 | $ | 3,581 | ||||
Accrued liabilities
|
7,087 | 10,658 | ||||||
Deferred revenue
|
5,982 | 17,044 | ||||||
Warrant liabilities
|
1,395 | 4,245 | ||||||
Total current liabilities
|
19,507 | 35,528 | ||||||
Deferred revenue – long-term
|
8,665 | 1,086 | ||||||
Interest bearing obligation – long-term
|
27,031 | 13,694 | ||||||
Other long-term liabilities
|
257 | 353 | ||||||
Total liabilities
|
55,460 | 50,661 | ||||||
Shareholders’ equity
|
24,138 | 23,591 | ||||||
Total liabilities and shareholders' equity
|
79,598 | 74,252 |
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) (USD $)
|
Jun. 30, 2011
|
Dec. 31, 2010
|
---|---|---|
Common shares, par value (in dollars per share) | $ 0.0075 | $ 0.0075 |
Common shares, shares authorized (in shares) | 92,666,666 | 92,666,666 |
Common shares, shares outstanding (in shares) | 32,200,731 | 28,491,318 |
Series B [Member]
|
 |  |
Preference shares, par value (in dollars per share) | $ 0.05 | $ 0.05 |
Preference shares, shares authorized (in shares) | 1,000,000 | 1,000,000 |
Preference shares, shares designated (in shares) | 8,000 | 8,000 |
Preference shares, shares issued (in shares) | 0 | 2,959 |
Preference shares, shares outstanding (in shares) | 0 | 2,959 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (USD $)
In Thousands, except Share data |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2011
|
Mar. 31, 2010
|
Jun. 30, 2011
|
Jun. 30, 2010
|
|
Revenues: | Â | Â | Â | Â |
License and collaborative fees | $ 6,039 | $ 150 | $ 11,866 | $ 339 |
Contract and other revenue | 10,467 | 5,481 | 20,128 | 12,292 |
Royalties | 19 | 311 | 126 | 513 |
Total revenues | 16,525 | 5,942 | 32,120 | 13,144 |
Operating expenses: | Â | Â | Â | Â |
Research and development | 18,281 | 19,346 | 35,628 | 36,933 |
Selling, general and administrative | 6,113 | 5,026 | 11,483 | 10,579 |
Total operating expenses | 24,394 | 24,372 | 47,111 | 47,512 |
Loss from operations | (7,869) | (18,430) | (14,991) | (34,368) |
Other income (expense): | Â | Â | Â | Â |
Investment and interest income | 18 | 6 | 28 | 9 |
Interest expense | (634) | (90) | (1,166) | (177) |
Other income (expense) | 355 | 2,950 | 1,678 | (2,813) |
Net loss before taxes | (8,130) | (15,564) | (14,451) | (37,349) |
Provision for income tax expense | 0 | (16) | (15) | (16) |
Net loss | $ (8,130) | $ (15,580) | $ (14,466) | $ (37,365) |
Basic and diluted net loss per common share | $ (0.27) | $ (0.93) | $ (0.49) | $ (2.24) |
Shares used in computing basic and diluted net loss per common share | 29,889 | 16,695 | 29,536 | 16,695 |
Document And Entity Information (USD $)
|
6 Months Ended | ||
---|---|---|---|
Jun. 30, 2011
|
Aug. 02, 2011
|
Jun. 30, 2010
|
|
Entity Registrant Name | XOMA LTD /DE/ | Â | Â |
Entity Central Index Key | 0000791908 | Â | Â |
Current Fiscal Year End Date | --12-31 | Â | Â |
Entity Well-known Seasoned Issuer | No | Â | Â |
Entity Voluntary Filers | No | Â | Â |
Entity Current Reporting Status | Yes | Â | Â |
Entity Filer Category | Accelerated Filer | Â | Â |
Entity Public Float | Â | Â | $ 104,378,157 |
Entity Common Stock, Shares Outstanding | Â | 32,554,155 | Â |
Document Fiscal Year Focus | 2011 | Â | Â |
Document Fiscal Period Focus | Q2 | Â | Â |
Document Type | 10-Q | Â | Â |
Amendment Flag | false | Â | Â |
Document Period End Date | Jun. 30, 2011 |
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Income Taxes
|
6 Months Ended |
---|---|
Jun. 30, 2011
|
|
Income Taxes [Abstract] | Â |
Income Taxes | 7. Income Taxes Income tax expense was not material for the three and six months ended June 30, 2011 or the comparable periods in 2010. The Company's effective tax rate will fluctuate from period to period due to several factors inherent in the nature of the Company's operations and business transactions. The factors that most significantly impact this rate include the variability of licensing transactions in foreign jurisdictions. |
Condensed Consolidated Financial Statement Detail
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2011
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Condensed Consolidated Financial Statement Detail [Abstract] | Â | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Condensed Consolidated Financial Statement Detail | 3. Condensed Consolidated Financial Statement Detail Comprehensive Loss Unrealized gain on the Company's available-for-sale securities is included in accumulated comprehensive income. Comprehensive loss and its components for the three and six months ended June 30, 2011 and 2010 was as follows (in thousands):
Net Loss Per Common Share Basic and diluted net loss per common share is based on the weighted average number of common shares outstanding during the period. Potentially dilutive securities are excluded from the calculation of earnings per share if their inclusion is anti-dilutive. The following table shows the total outstanding securities considered anti-dilutive and therefore excluded from the computation of diluted net loss per share (in thousands):
For the three and six months ended June 30, 2011 and 2010, all outstanding securities were considered anti-dilutive, and therefore the calculations of basic and diluted net losses per share were the same. Cash and Cash Equivalents At June 30, 2011, cash equivalents consisted of demand deposits, money market funds and treasury bonds with maturities of less than 90 days at the date of purchase. At December 31, 2010, cash equivalents consisted of demand deposits, money market funds and repurchase agreements with maturities of less than 90 days at the date of purchase. The treasury bond held in cash and cash equivalents is classified as an available-for-sale security and is stated at fair value, with unrealized gains and losses, net of tax, if any, reported in other comprehensive income. The estimate of fair value is based on publicly-available market information. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities are included in investment and interest income. The cost of investments sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are also included in investment and interest income. Cash and cash equivalent balances were recorded at fair value as follows as of June 30, 2011 and December 31, 2010 (in thousands):
Foreign Exchange Options The Company holds debt and may incur expenses denominated in foreign currencies, which exposes it to market risk associated with foreign currency exchange rate fluctuations between the U.S. dollar and the Euro. The Company is required to make principal and accrued interest payments in Euros on its €15.0 million loan from Les Laboratoires Servier (“Servier”) (refer to Note 6 below). In order to manage its foreign currency exposure related to these payments, in May of 2011, the Company entered into two foreign exchange option contracts to buy €15.0 million and €1.5 million on January 2016 and January 2014, respectively. By having these option contracts in place, the Company's foreign exchange rate risk is reduced if the U.S. dollar weakens against the Euro. However, if the U.S. dollar strengthens against the Euro, the Company is not required to exercise these options, but will not receive any refund on premiums paid. Upfront premiums paid on these foreign exchange option contracts totaled $1.5 million. The fair values of these option contracts are re-valued at each reporting period and are estimated based on pricing models using readily observable inputs from actively quoted markets. The fair values of these option contracts are included in other assets on the condensed consolidated balance sheet and changes in fair value on these contracts are included in other income (expense) on the condensed consolidated statements of operations. The foreign exchange options were revalued at June 30, 2011 and had an aggregate fair value of $1.7 million, and the Company recognized a gain of $0.2 million related to the revaluation for the three and six months ended June 30, 2011. Receivables Receivables consisted of the following at June 30, 2011 and December 31, 2010 (in thousands):
Property and Equipment Property and equipment consisted of the following at June 30, 2011 and December 31, 2010 (in thousands):
Depreciation expense was $1.4 million and $2.7 million for the three and six months ended June 30, 2011, respectively, compared with $1.4 million and $3.0 million, respectively, for the same periods in 2010. Accrued Liabilities Accrued liabilities consisted of the following at June 30, 2011 and December 31, 2010 (in thousands):
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Share Capital
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6 Months Ended |
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Jun. 30, 2011
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Preferred Stock [Abstract] | Â |
Share Capital | 9. Share Capital Series B Preference Shares In December of 2003, the Company issued 2,959 Series B preference shares to Genentech, Inc. in repayment of $29.6 million of the outstanding balance under a convertible subordinated debt agreement. Pursuant to the rights of the Series B preference shares, the holder of Series B preference shares was not entitled to receive any dividends on the Series B preference shares. The Series B preference shares ranked senior with respect to rights on liquidation, winding-up and dissolution of the Company to all classes of common shares. Upon any voluntary or involuntary liquidation, dissolution or winding-up of the Company, the holder of Series B preference shares would have been entitled to receive $10,000 per Series B preference share (or $29.6 million in the aggregate) before any distribution was made on the common shares. The holder of the Series B preference shares had no voting rights, except as required under Bermuda law. The holder of Series B preference shares had the right to convert Series B preference shares into common shares at a conversion price equal to $116.25 per common share, subject to adjustment in certain circumstances. In April of 2011, the 2,959 Series B convertible preference shares were converted by Genentech into 254,560 common shares. The $29.6 million liquidation preference associated with the Series B preference shares was eliminated as a result of this conversion. |
Legal Proceedings, Commitments and Contingencies
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6 Months Ended |
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Jun. 30, 2011
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Legal Proceedings, Commitments and Contingencies [Abstract] | Â |
Legal Proceedings, Commitments and Contingencies | 10. Legal Proceedings, Commitments and Contingencies On April 9, 2009, a complaint was filed in the Superior Court of Alameda County, California, in a lawsuit captioned Hedrick et al. v. Genentech, Inc. et al, Case No. 09-446158. The complaint asserts claims against Genentech, the Company and others for alleged strict liability for failure to warn, strict product liability, negligence, breach of warranty, fraudulent concealment, wrongful death and other claims based on injuries alleged to have occurred as a result of three individuals' treatment with RAPTIVA®. The complaint seeks unspecified compensatory and punitive damages. Since then, additional complaints have been filed in the same court, bringing the total number of pending cases to seventy five. The cases have been consolidated as a coordinated proceeding. All of the complaints allege the same claims and seek the same types of damages based on injuries alleged to have occurred as a result of the plaintiffs' treatment with RAPTIVA®. On July 15, 2011, the Court dismissed with prejudice one of the cases in this coordinated proceeding, White v. Genentech, Inc., et al, Case No. RG-09-484026. The Company's agreement with Genentech provides for an indemnity of XOMA and payment of legal fees by Genentech which the Company believes is applicable to these matters. The Company believes the claims against it to be without merit and intends to defend against them vigorously. On August 4, 2010, a petition was filed in the District Court of Dallas County, Texas in a case captioned McCall v. Genentech, Inc., et al., No. 10-09544. The defendants filed a Notice of Removal to the United States District Court for the Northern District of Texas on September 3, 2010. The removed case is captioned McCall v. Genentech, Inc., et al., No. 3:10-cv-01747-B. The parties have fully briefed the plaintiff's Motion to Remand and are awaiting a final ruling from the Court. The petition asserts personal injury claims against Genentech, the Company, and others arising out of the plaintiff's treatment with RAPTIVA®. The petition alleges claims based on negligence, strict liability, misrepresentation and suppression, conspiracy, and actual and constructive fraud. The petition seeks compensatory damages and punitive damages in an unspecified amount. On June 6, 2011, the Court dismissed plaintiff's claims of negligent misrepresentation, fraud, and conspiracy. The Company's agreement with Genentech provides for an indemnity of XOMA and payment of legal fees by Genentech which the Company believes is applicable to this matter. The Company believes the claims against it to be without merit and intends to defend against them vigorously On January 7, 2011, a complaint was filed in the United States District Court for the Northern District of Texas in a case captioned Massa v. Genentech, Inc., et al., No. 4:11CV70. On January 11, 2011, a complaint was filed in the United States District Court for the District of Massachusetts in a case captioned Sylvia, et al. v. Genentech, Inc., et al., No. 1:11-cv-10054-MLW. These two complaints allege the same claims against Genentech, the Company and others and seek the same types of damages as the complaints filed in the Superior Court of Alameda County, California referenced above. The Company's agreement with Genentech provides for an indemnity of XOMA and payment of legal fees by Genentech which the Company believes is applicable to these matters. The Company believes the claims against it to be without merit and intends to defend against them vigorously. On April 8, 2011, four complaints were filed in the United States District Court for the Eastern District of Michigan. The cases are captioned: Muniz v. Genentech, et al., 5:11-cv-11489-JCO-RSW; Tifenthal v. Genentech, et al., 2:11-cv-11488-DPH-LJM; Blair v. Genentech, et al., 2:11-cv-11463-SFC-MJH; and Marsh v. Genentech, et al., 2:11-cv-11462-RHC-MKM. The complaints allege the same claims against Genentech, the Company and others and seek the same types of damages as the complaints filed in the Superior Court of Alameda County, California referenced above. All four cases have been transferred to the United States District Court for the Western District of Michigan. Genentech and the Company have filed Motions to Dismiss all four actions and are awaiting a decision from the Court. The Company's agreement with Genentech provides for an indemnity of XOMA and payment of legal fees by Genentech which the Company believes is applicable to this matter. The Company believes the claims against it to be without merit and intends to defend against them vigorously. |
Share-Based Compensation
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Jun. 30, 2011
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Share-Based Compensation Note [Abstract] | Â | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation | 8. Share-Based Compensation In December of 2010, the Board of Directors of the Company approved a company-wide grant of share options under the Company's 2010 Long Term Incentive and Share Award Plan (“LTIP”) and, in the first quarter of 2011, the options for 1,430,840 shares became effective. 1,040,220 of these options were granted subject to shareholder approval of an increase in the number of shares available under the LTIP. On May 26, 2011, shareholder approval was obtained at the Company's annual general meeting of shareholders. A cumulative adjustment of $1.3 million was recorded in the second quarter of 2011 to reflect the share-based compensation expense that would have been recorded from the conditional grant date to the shareholder approval date. The adjustment was based on the fair value of these options at the date of shareholder approval and calculated using the closing share price and expected term on that date. The remaining assumptions included in the calculation were the same assumptions used for the second quarter option grants. A portion of the 2011 annual options granted include immediate vesting terms with the remainder of the options vesting monthly over two years for employees and one year for directors. As of June 30, 2011, the Company had approximately 4,562,486 common shares reserved for future issuance under its share option plans and Employee Share Purchase Plan (“ESPP”). The following table shows total share-based compensation expense included in the condensed consolidated statements of operations for the three and six months ended June 30, 2011 and 2010 (in thousands):
The valuation of share-based compensation awards is determined at the date of grant using the Black-Scholes Model. This model requires inputs such as the expected term of the option, expected volatility and risk-free interest rate. Further, the forfeiture rate also affects the amount of aggregate compensation. These inputs are subjective and generally require significant analysis and judgment to develop. While estimates of the expected term, volatility and forfeiture rate are derived primarily from the Company's historical data, the risk-free rate is based on the yield available on United States Treasury zero-coupon issues. The fair value of share-based awards was estimated based on the following weighted average assumptions for the three and six months ended June 30, 2011 and 2010:
Share option activity for the six months ended June 30, 2011 was as follows:
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Description of Business
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6 Months Ended |
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Jun. 30, 2011
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Description of Business [Abstract] | Â |
Description of Business | 1. Description of Business XOMA Ltd. (“XOMA” or the “Company”), a Bermuda company, is a biopharmaceutical company focused on the discovery, development and manufacture of therapeutic antibodies designed to treat inflammatory, autoimmune, infectious and oncological diseases. The Company's products are presently in various stages of development and are subject to regulatory approval before they can be commercially launched. |
Fair Value Measurements
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Jun. 30, 2011
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Fair Value Measurements [Abstract] | Â | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | 4. Fair Value Measurements Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions and risk of nonperformance. A fair value hierarchy was established which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. A financial instrument's categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The three levels of inputs that may be used to measure fair value are as follows:
The following tables set forth the Company's fair value hierarchy for its financial assets (cash equivalents) and liabilities measured at fair value on a recurring basis as of June 30, 2011 and December 31, 2010. Financial assets and liabilities carried at fair value as of June 30, 2011 and December 31, 2010 were classified as follows (in thousands):
(1) Included in cash and cash equivalents The fair value of the foreign exchange options at June 30, 2011 was determined using readily observable market inputs from actively quoted markets obtained from various third party data providers. These inputs, such as spot rate, forward rate and volatility have been derived from readily observable market data, meeting the criteria for Level 2 in the fair value hierarchy. The fair value of the warrant liabilities at June 30, 2011 and December 31, 2010 was determined using the Black-Scholes Model, which requires inputs such as the expected term of the warrants, share price volatility and risk-free interest rate. These inputs are subjective and generally require significant analysis and judgment to develop. The fair value of the warrant liabilities was estimated using the following range of assumptions at June 30, 2011 and December 31, 2010:
The following table provides a summary of changes in the fair value of the Company's Level 3 financial liabilities for the six months ended June 30, 2011 (in thousands):
For the three and six months ended June 30, 2011, the Company recognized net decreases of $0.5 million and $2.9 million, respectively, in the estimated fair value of the warrant liabilities resulting in recognized gains in the other income (expense) line of the condensed consolidated statements of operations. For the three and six months ended June 30, 2010, the Company recognized net decreases of $3.0 million and $1.7 million, respectively, in the estimated fair value of the warrant liabilities resulting in recognized gains in the other income (expense) line of the condensed consolidated statements of operations. |
Licensing, Collaborative and Other Arrangements
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6 Months Ended |
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Jun. 30, 2011
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Licensing, Collaborative and Other Arrangements [Abstract] | Â |
Licensing, Collaborative and Other Arrangements | 5. Licensing, Collaborative and Other Arrangements Servier In December of 2010, the Company entered into a license and collaboration agreement with Servier, to jointly develop and commercialize XOMA 052 in multiple indications, which provided for a non-refundable upfront payment of $15.0 million that was received by the Company in January of 2011. The upfront payment will be recognized over the estimated eight month period that the initial group of deliverables will be provided to Servier. The Company recognized $5.5 million and $11.0 million in revenue relating to this upfront payment during the three and six months ended June 30, 2011, respectively. In addition, the Company received a loan of €15.0 million, which was fully funded in January of 2011, with the proceeds converting to $19.5 million at the date of funding (refer to Note 6 below). Also, the Company retains development and commercialization rights for Behcet's uveitis and other inflammatory and oncology indications in the U.S. and Japan, and an option to reacquire rights to diabetes and cardiovascular disease indications from Servier in these territories. Servier will fully fund activities to advance the global clinical development and future commercialization of XOMA 052 in diabetes and cardiovascular related diseases, as well as the first $50.0 million of future XOMA 052 global clinical development and chemistry and manufacturing controls expenses and 50% of further expenses for the Behcet's uveitis indication, which is expected to advance into Phase 3 development in 2012. For the three and six months ended June 30, 2011, the Company recorded revenue of $10.1 million and $17.7 million, respectively, under this agreement, which included the revenue relating to the upfront payment. Merck/Schering-Plough In May of 2006, the Company entered into a fully funded collaboration agreement with Schering-Plough Research Institute, a division of Schering Corporation, now a subsidiary of Merck (“Merck/Schering-Plough”) for therapeutic monoclonal antibody discovery and development. Under the agreement, Merck/Schering-Plough made up-front, annual maintenance and milestone payments to the Company, funded its research and development activities related to the agreement and would have paid royalties on sales of products resulting from the collaboration. During the collaboration, the Company discovered therapeutic antibodies against multiple targets selected by Merck/Schering-Plough using multiple human antibody phage display libraries, optimized antibodies through affinity maturation or other protein engineering, used the Company's proprietary HE™ technology to humanize antibody candidates generated by hybridoma techniques, performed preclinical studies to support regulatory filings, developed cell lines and production processes and produced antibodies for initial clinical trials. Merck/Schering-Plough selected the first target at the inception of the agreement and, in December of 2006, exercised its right to initiate the additional discovery and development programs. In January of 2011, the Company successfully completed the contract services it had agreed to perform under the collaboration agreement with Merck/Schering-Plough. |
Long-Term Debt and Other Financings
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Jun. 30, 2011
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Long-Term Debt and Other Financings | 6. Long-Term Debt and Other Financings Long-Term Debt Novartis Note In May of 2005, the Company executed a secured note agreement with Novartis (then Chiron Corporation), which is due and payable in full in June of 2015. Under this note agreement, the Company borrowed semi-annually to fund up to 75% of the Company's research and development and commercialization costs under its collaboration arrangement with Novartis, not to exceed $50.0 million in aggregate principal amount. Interest on the principal amount of the loan accrues at six-month LIBOR plus 2%, which was equal to 2.39% at June 30, 2011, and is payable semi-annually in June and December of each year. At the Company's election, the semi-annual interest payments can be added to the outstanding principal amount, in lieu of a cash payment, as long as the aggregate principal amount does not exceed $50.0 million. The Company has made this election for all interest payments thus far. Loans under the note agreement are secured by the Company's interest in the collaboration with Novartis, including any payments owed to it thereunder. At June 30, 2011 and December 31, 2010, the outstanding principal balance under this note agreement was $13.9 million and $13.7 million, respectively. Pursuant to the terms of the arrangement as restructured in November of 2008, the Company will not make any additional borrowings under the Novartis note. Due to the structure of the secured note agreement with Novartis and since there is no liquid market for this obligation, there is no practical method to estimate fair value of this long-term debt. Servier Loan In December of 2010, in connection with the license and collaboration agreement entered into with Servier (see footnote 5), the Company executed a loan agreement with Servier, which provided for an advance of up to €15.0 million. The loan was fully funded in January of 2011, with the proceeds converting to approximately $19.5 million. The loan is secured by an interest in XOMA's intellectual property rights to all XOMA 052 indications worldwide, excluding certain rights in the U.S. and Japan. Interest is calculated at a floating rate based on a Euro Inter-Bank Offered Rate (“EURIBOR”) and subject to a cap. The interest rate is reset semi-annually in January and July of each year. The interest rate for the initial interest period was 3.22%. The interest rate has been reset to 3.83% for six-month period from July 2011 through January 2012. Interest is payable semi-annually; however, the loan agreement provides for a deferral of interest payments over a period specified in the agreement. During the deferral period, accrued interest will be added to the outstanding principal amount for the purpose of interest calculation for the next six-month interest period. On the repayment commencement date, all unpaid and accrued interest shall be paid to Servier and thereafter, all accrued and unpaid interest shall be due and payable at the end of each six-month period. The loan matures in 2016; however, after a specified period prior to final maturity, the loan is to be repaid (i) at Servier's option, by applying up to a significant percentage of any milestone or royalty payments owed by Servier under the Company's collaboration agreement and (ii) using a significant percentage of any upfront, milestone or royalty payments the Company receives from any third party collaboration or development partner for rights to XOMA 052 in the U.S. and/or Japan. In addition, the loan becomes immediately due and payable upon certain customary events of default. At June 30, 2011, the outstanding principal balance under this loan was $21.6 million. For the three and six months ended June 30, 2011, the Company recorded unrealized foreign exchange losses of $0.5 million and $2.1 million, respectively, related to the re-measurement of the loan as of June 30, 2011. The loan has a stated interest rate lower than the market rate based on comparable loans held by similar companies, which represents additional value to the Company. The Company recorded this additional value as a discount to the face value of the loan amount, at its fair value of $8.9 million. The fair value of this discount, which was determined using a discounted cash flow model, represents the differential between the stated terms and rates of the loan, and market rates. Based on the association of the loan with the collaboration arrangement, the Company recorded the offset to this discount as deferred revenue. The loan discount is amortized under the effective interest method over the expected five-year life of the loan. The Company recorded non-cash interest expense of $0.4 million and $0.7 million during the three and six months ended June 30, 2011, respectively, resulting from the amortization of the loan discount. At June 30, 2011, the net carrying value of the loan was $13.2 million. The Company believes that realization of the benefit and the associated deferred revenue is contingent on the loan remaining outstanding over the five-year contractual term of the loan. If the Company were to stop providing service under the collaboration arrangement and the arrangement is terminated, the maturity date of the loan would be accelerated and a portion of measured benefit would not be realized. As the realization of the benefit is contingent, in part, on the provision of future services, the Company is recognizing the deferred revenue over the expected five-year life of the loan. The deferred revenue is amortized under the effective interest method, and the Company recorded $0.4 million and $0.7 million of related non-cash revenue during the three and six months ended June 30, 2011, respectively. Interest Expense Interest expense for the Novartis note and Servier loan are shown below (in thousands):
Other Financings ATM Agreements In the third quarter of 2010, the Company entered into an At Market Issuance Sales Agreement (the “2010 ATM Agreement”), with Wm Smith & Co. and McNicoll, Lewis & Vlak LLC (the “Agents”), under which the Company could sell common shares from time to time through the Agents, as its agents for the offer and sale of the common shares, in an aggregate amount not to exceed the amount that could be sold under its registration statement on Form S-3 (File No. 333-148342) filed with the SEC on December 26, 2007. The Agents could sell the common shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”), including without limitation sales made directly on The NASDAQ Global Market, on any other existing trading market for the common shares or to or through a market maker. The Agents could also sell the common shares in privately negotiated transactions, subject to the Company's prior approval. The Company paid the Agents, collectively, a commission equal to 3% of the gross proceeds of the sales price of all common shares sold through them as sales agents under the 2010 ATM Agreement. From the inception of the 2010 ATM Agreement through May of 2011, the Company sold a total of 7,560,862 common shares under this agreement for aggregate gross proceeds of $34.0 million, including 821,386 common shares sold in 2011 for aggregate gross proceeds of $4.4 million. Total offering expenses incurred related to sales under the 2010 ATM Agreement from inception to May of 2011 were $1.0 million, including $0.1 million incurred in 2011. In May of 2011, the 2010 ATM Agreement expired by its terms, and there will be no further issuances under this facility. On February 4, 2011, the Company entered into an At Market Issuance Sales Agreement (the “2011 ATM Agreement”), with McNicoll, Lewis & Vlak LLC (“MLV”), under which the Company may sell common shares from time to time through MLV, as its agent for the offer and sale of the common shares, in an aggregate amount not to exceed the amount that can be sold under the Company's registration statement on Form S-3 (File No. 333-172197) filed with the SEC on February 11, 2011 and amended on March 10, 2011 and June 3, 2011, which was declared effective by the SEC on June 6, 2011. MLV may sell the common shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act, including without limitation sales made directly on The NASDAQ Global Market, on any other existing trading market for the common shares or to or through a market maker. MLV may also sell the common shares in privately negotiated transactions, subject to the Company's prior approval. The Company will pay MLV a commission equal to 3% of the gross proceeds of the sales price of all common shares sold through them as sales agent under the 2011 ATM Agreement. From the inception of the 2011 ATM Agreement through June 30, 2011, the Company sold a total of 2,398,017 common shares under this agreement for aggregate gross proceeds of $5.9 million, of which $3.7 million of cash was received in June of 2011 with the remaining $2.2 million of cash received in July of 2011. Total offering expenses incurred related to sales under the 2011 ATM Agreement from inception to June 30, 2011 were $0.2 million. |
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