Table of Contents
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark
One)
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
|
FOR THE QUARTERLY PERIOD ENDED June 30,
2009
OR
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15
(d) OF THE SECURITIES EXCHANGE ACT
|
FOR
THE TRANSITION PERIOD FROM
TO
COMMISSION FILE NUMBER 000-30469
deCODE
genetics, Inc.
(Exact Name of
Registrant as Specified in Its Charter)
Delaware
|
|
04-3326704
|
(State or Other
Jurisdiction of
|
|
(I.R.S. Employer
Identification No.)
|
Incorporation or
Organization)
|
|
|
STURLUGATA 8, IS-101 REYKJAVIK,
ICELAND
(Address of
Principal Executive Offices)
+354-570-1900
(Registrants
Telephone Number, Including Area Code)
Indicate by check whether
the registrant: (1) has filed all reports required to be filed by Section 13
or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements for
the past 90 days.
x
Yes
o
No
Indicate by check mark
whether the registrant has submitted electronically and posted on its corporate
Web site, if any, every Interactive Data File required to be submitted and
posted pursuant to Rule 405 of Regulation S-T (§232.05 of this chapter)
during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files).
o
Yes
o
No
Indicate by check mark
whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2
of the Exchange Act. (Check one):
Large
accelerated filer
o
|
|
Accelerated
filer
x
|
|
|
|
Non-accelerated
filer
o
|
|
Smaller
reporting company
o
|
(Do not check if
a smaller reporting company)
|
|
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act).
o
Yes
x
No
The aggregate
number of shares of the registrants common stock outstanding on July 31,
2009 was 61,760,805 shares of common stock $.001 par value.
Table of Contents
PART I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
deCODE
genetics, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
June 30,
2009
|
|
December 31,
2008
|
|
|
|
(In
thousands, except
share amounts)
|
|
ASSETS
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
3,765
|
|
$
|
3,701
|
|
Receivables
|
|
5,879
|
|
6,077
|
|
Other current assets
|
|
1,918
|
|
4,029
|
|
Current assets of discontinued operations (Note 12)
|
|
3,540
|
|
3,928
|
|
Total current assets
|
|
15,102
|
|
17,735
|
|
Investments (pledged at June 30, 2009, see Note
9)
|
|
13,517
|
|
12,721
|
|
Property and equipment, net
|
|
1,873
|
|
3,325
|
|
Goodwill
|
|
10,055
|
|
10,055
|
|
Intangible assets, net
|
|
3,369
|
|
3,516
|
|
Other long-term assets
|
|
3,039
|
|
3,826
|
|
Long-term assets of discontinued operations (Note
12)
|
|
22,898
|
|
23,959
|
|
Total assets
|
|
$
|
69,853
|
|
$
|
75,137
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
|
7,034
|
|
$
|
7,293
|
|
Accrued expenses and other current liabilities
|
|
5,105
|
|
5,667
|
|
Deferred revenue
|
|
5,089
|
|
4,881
|
|
Secured debt collateralized by auction rate
securities (Note 9)
|
|
11,664
|
|
|
|
Current portion of capital lease obligations
|
|
748
|
|
2,202
|
|
Current liabilities of discontinued operations (Note
12)
|
|
5,381
|
|
8,577
|
|
Total current liabilities
|
|
35,021
|
|
28,620
|
|
Deferred revenue
|
|
16,219
|
|
6,219
|
|
Deferred gain on sale-leaseback
|
|
20,871
|
|
21,840
|
|
Long-term debt, net of current portion
|
|
218,672
|
|
215,962
|
|
Long-term liabilities of discontinued operations
(Note 12)
|
|
23,144
|
|
23,572
|
|
Commitments and contingencies
|
|
|
|
|
|
Stockholders deficit:
|
|
|
|
|
|
Preferred stock, $0.001 par value; Authorized:
6,716,666 shares; Issued and outstanding: none
|
|
|
|
|
|
Common stock, $0.001 par value; Authorized:
150,000,000 shares; Issued and outstanding: 61,882,584 and 61,760,805,
respectively, at June 30, 2009 and 61,882,584 and 61,762,805,
respectively, at December 31, 2008
|
|
62
|
|
62
|
|
Additional paid-in capital
|
|
494,753
|
|
493,381
|
|
Notes receivable
|
|
(1,886
|
)
|
(1,900
|
)
|
Accumulated deficit
|
|
(737,994
|
)
|
(712,161
|
)
|
Accumulated other comprehensive income
|
|
1,566
|
|
103
|
|
Treasury stock, 121,779 and 119,779 shares stated at
cost at June 30, 2009 and December 31, 2008, respectively
|
|
(575
|
)
|
(561
|
)
|
Total stockholders deficit
|
|
(244,074
|
)
|
(221,076
|
)
|
Total liabilities and stockholders deficit
|
|
$
|
69,853
|
|
$
|
75,137
|
|
The accompanying notes are an integral part of these
condensed consolidated financial statements.
2
Table of Contents
deCODE
genetics, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
3,501
|
|
$
|
8,956
|
|
$
|
7,613
|
|
$
|
18,129
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Cost of revenue
|
|
4,436
|
|
8,199
|
|
8,555
|
|
18,343
|
|
Research and development
|
|
2,841
|
|
7,964
|
|
6,872
|
|
20,578
|
|
Selling, general and administrative
|
|
4,318
|
|
5,929
|
|
8,582
|
|
11,678
|
|
Total operating expenses
|
|
11,595
|
|
22,092
|
|
24,009
|
|
50,599
|
|
Operating income (loss) from continuing operations
|
|
(8,094
|
)
|
(13,136
|
)
|
(16,396
|
)
|
(32,470
|
)
|
Interest income
|
|
18
|
|
452
|
|
175
|
|
1,489
|
|
Interest expense
|
|
(4,380
|
)
|
(3,716
|
)
|
(8,611
|
)
|
(7,336
|
)
|
Other non-operating income and (expense), net
|
|
330
|
|
(1,170
|
)
|
565
|
|
(5,247
|
)
|
Loss from continuing operations
|
|
(12,126
|
)
|
(17,570
|
)
|
(24,267
|
)
|
(43,564
|
)
|
Loss from discontinued operations (Note 12)
|
|
(1,070
|
)
|
(784
|
)
|
(1,566
|
)
|
(1,455
|
)
|
Net loss
|
|
$
|
(13,196
|
)
|
$
|
(18,354
|
)
|
$
|
(25,833
|
)
|
$
|
(45,019
|
)
|
Basic and diluted net loss per share from
continuing operations
|
|
$
|
(0.20
|
)
|
$
|
(0.29
|
)
|
$
|
(0.39
|
)
|
$
|
(0.71
|
)
|
Basic and diluted net loss per share from
discontinued operations
|
|
(0.01
|
)
|
(0.01
|
)
|
(0.03
|
)
|
(0.02
|
)
|
Basic and diluted net loss per share
|
|
$
|
(0.21
|
)
|
$
|
(0.30
|
)
|
$
|
(0.42
|
)
|
$
|
(0.73
|
)
|
Shares used in computing basic and diluted net
loss per share
|
|
61,489
|
|
61,371
|
|
61,481
|
|
61,318
|
|
The accompanying notes are an integral part of these
condensed consolidated financial statements.
3
Table of Contents
deCODE
genetics, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS
(Unaudited)
|
|
6 Months
Ended June 30,
|
|
|
|
2009
|
|
2008
|
|
|
|
(in thousands)
|
|
CASH FLOWS FROM OPERATING
ACTIVITIES:
|
|
|
|
|
|
Net loss
|
|
$
|
(25,833
|
)
|
$
|
(45,019
|
)
|
Subtract loss from discontinued operations (Note 12)
|
|
(1,566
|
)
|
(1,448
|
)
|
Net loss from continuing operations
|
|
(24,267
|
)
|
(43,571
|
)
|
Adjustments to reconcile net loss to net cash used
in operating activities of continuing operations:
|
|
|
|
|
|
Depreciation and amortization
|
|
1,622
|
|
2,225
|
|
Amortization of deferred gain on sale-leaseback of
real estate
|
|
(969
|
)
|
(969
|
)
|
Stock-based compensation
|
|
1,215
|
|
1,819
|
|
Loss on investments
|
|
664
|
|
5,107
|
|
Foreign currency transaction
|
|
(639
|
)
|
59
|
|
Amortization of debt discount
|
|
2,710
|
|
2,416
|
|
Amortization of deferred financing costs
|
|
787
|
|
815
|
|
Interest related to secured borrowing
|
|
992
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
Receivables and other assets
|
|
2,309
|
|
(1,279
|
)
|
Accounts payable, accrued expenses and other current
liabilities
|
|
(821
|
)
|
(2,161
|
)
|
Deferred revenue
|
|
10,208
|
|
(342
|
)
|
Net cash used in operating activities of continuing
operations
|
|
(6,189
|
)
|
(35,881
|
)
|
Net cash used in operating activities of
discontinued operations (Note 12)
|
|
(3,252
|
)
|
(2,101
|
)
|
Net cash used in operating activities
|
|
(9,441
|
)
|
(37,982
|
)
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
Purchase of investments
|
|
|
|
(5,500
|
)
|
Sale of investments
|
|
|
|
10,000
|
|
Purchase of property and equipment
|
|
(24
|
)
|
(568
|
)
|
Change in restricted cash and cash equivalents
|
|
270
|
|
|
|
Net cash provided by investing activities of
continuing operations
|
|
246
|
|
3,932
|
|
Net cash used in investing activities of
discontinued operations (Note 12)
|
|
(172
|
)
|
(202
|
)
|
Net cash provided by investing activities
|
|
74
|
|
3,730
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
|
|
172
|
|
Repayment of notes receivable for common stock
|
|
|
|
75
|
|
Proceeds from secured borrowing
|
|
11,314
|
|
|
|
Repayments of debt, capital lease and finance
obligations
|
|
(1,454
|
)
|
(1,549
|
)
|
Net cash provided by (used in) financing activities
of continuing operations
|
|
9,860
|
|
(1,302
|
)
|
Net cash used in financing activities of
discontinued operations (Note 12)
|
|
(429
|
)
|
(380
|
)
|
Net cash provided by (used in) financing activities
|
|
9,431
|
|
(1,682
|
)
|
Net increase (decrease) in cash and cash equivalents
|
|
64
|
|
(35,934
|
)
|
Cash and cash equivalents at beginning of period
|
|
3,701
|
|
54,172
|
|
Cash and cash equivalents at end of period
|
|
$
|
3,765
|
|
$
|
18,238
|
|
Supplemental cash flow information:
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
4,782
|
|
$
|
4,929
|
|
The accompanying notes are an integral part of these
condensed consolidated financial statements.
4
Table of Contents
deCODE
genetics, Inc.
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS (UNAUDITED)
(tabular amounts
in thousands, except share and per share amounts)
1. Organization and Business
References in these
financial statements to deCODE refer to deCODE genetics, Inc., a Delaware
company, and its wholly owned subsidiaries, Islensk erfdagreining ehf., an
Icelandic company registered in Reykjavik, and its subsidiaries and MediChem
Life Sciences, Inc., a Delaware corporation, and its subsidiaries.
With its headquarters in
Reykjavik, Iceland, deCODE is a biotechnology company developing and marketing
products to improve the treatment, diagnosis and prevention of common diseases.
deCODE applies its discoveries in human genetics to bring to market DNA-based
reference laboratory tests and consumer genome analysis services to assess
individual risk of common diseases. deCODEs customers include major
pharmaceutical companies, biotechnology firms, pharmacogenomics companies,
government institutions, universities and other research institutions. deCODEs
business is global, with its principal markets in the United States and in
Europe.
deCODEs advantage in
DNA-based disease risk assessment tests and personal genomics is derived from
its population approach to human genetics and the ability to apply its
discoveries directly to the development of DNA-based reference laboratory tests
for common diseases and to its retail genome scans. deCODE has in Iceland
comprehensive population resources and one of the largest genotyping facilities
in the world, enabling its scientists to effectively identify key variations in
the sequence of the human genome associated with a major impact on individual
risk of common diseases. Well-validated genetic variations conferring risk of
disease are the basis for DNA-based reference laboratory tests and personal
genome scans that can more accurately assess individual risk of disease. As
virtually all common diseases have both genetic and environmental risk factors,
measuring genetic risk is in deCODEs view a critical component for the
realization of personalized medicine. By providing a more complete
understanding of individual risk, such tests can empower better prevention in
those conditions in which known lifestyle and environmental risk can be
modified, as well as targeted screening and early intervention in diseases such
as cancer.
Going
Concern
: The
financial statements have been prepared on a going-concern basis, which
contemplates the recoverability of assets and the satisfaction of liabilities
in the normal course of business. deCODE has recorded substantial operating and
net losses. Its negative cash flows from operations have been $9,335,000 and
$37,982,000 during the six-months ended June 30, 2009 and 2008,
respectively, and $54,779,000 during the year ended December 31, 2008. In
addition, deCODE has significant amounts of long-term debt which requires
interest payments of approximately $8,050,000 per annum. At June 30, 2009,
deCODE had liquid funds available for operating activities of $3,765,000 (cash
and cash equivalents) as compared to $3,701,000 at December 31, 2008.
At
June 30, 2009, deCODE had cash and cash equivalents
of $3,765,000, compared to $3,701,000 at
December 31, 2008. In early 2009 deCODE sold its ARS for approximately
$11,314,000 in cash, and in April deCODE signed licensing agreements with
Celera Corporation (Celera) under which it received an upfront payment of
$10.0 million and will receive royalties on sales of Celera testing products
and services incorporating deCODE genetic risk
markers.
deCODE believes it has
sufficient resources to fund operations only into the latter half of the third
quarter. It is simultaneously pursuing several options to ensure sufficient
funding to take it to the execution of strategic options that can support the
near- and longer-term viability of its core business.
deCODEs planned operations require
immediate additional liquidity substantially in excess of the amounts noted
above, raising substantial doubt about deCODEs ability to continue as a going
concern.
In deCODEs ongoing
strategic review, deCODE has been evaluating and pursuing various alternatives
aimed at focusing its business and underpinning ongoing product development and
commercialization in its core business. One component of this effort is the
sale of deCODEs US medicinal chemistry and structural biology units. Although
these units continue to operate and contribute
to deCODE, in view of their prospective sale
the company has accounted for these businesses as discontinued operations
(see Note 12). With the exception of combined net loss figures, the operating
results are thus all for deCODEs continuing operations in its core business of
employing the Companys capabilities in gene discovery to advance DNA-based
diagnostics, personal genome analysis, intellectual property licensing
opportunities, and contract genotyping.
Managements Plans:
To address deCODEs
immediate need for funds, management and the Board of Directors are exploring
the possibilities of (i) selling some or all of deCODEs U.S. medicinal
chemistry and structural biology units (as noted above), (ii) granting
further licenses to specific diagnostic products, (iii) entering into a
collaboration for gene sequencing, (iv) selling or licensing some or all
of deCODEs clinical and pre-clinical drug discovery programs, (v) restructuring
deCODEs outstanding convertible notes and (vi) obtaining new equity
financing. Achieving (v) could result in either a cash settlement of
deCODEs convertible note obligation for substantially less than the carrying
amount or in a conversion of the convertible notes into equity of deCODE.
Receipt of additonal equity financing to support operations in the longer term
depends in large part on the outcomes of actions in (i), (ii), (iii) and
(v). Management and the board are having ongoing dialogues and negotiations
with third parties in each of these areas. If deCODEs Board of Directors concludes
that any of these options can be better implemented in a bankruptcy proceeding,
deCODE will commence a proceeding under Chapter 11 of the U.S. Bankruptcy Code.
5
Table of Contents
Whether in a bankruptcy
proceeding or otherwise, the consummation of any of these approaches is
dependent on successful negotiations with third parties and in many cases the
availability of financing to such third parties. There can be no asssurance
that any potential transactions will be consummated or will result in
sufficient funding to sustain operations. If deCODE is unable to
raise additional capital through one or
more of these options, it may be forced to liquidate its remaining assets and
discontinue as a business.
2. Basis of Presentation
In the opinion of deCODEs
management, the accompanying unaudited condensed consolidated financial
statements contain all adjustments (consisting of items of a normal and
recurring nature) necessary to present fairly the financial position as of June 30,
2009 and the results of operations for the three and six-month periods ended June 30,
2009 and 2008 and cash flows for the six-month periods ended June 30, 2009
and 2008. deCODE considers events or transactions that occur after the
balance sheet date but before the financial statements are issued to provide
additional evidence relative to certain estimates or to identify matters that
require additional disclosure. Subsequent events have been evaluated through August 10,
2009. The results of operations for the three and six-month periods ended June 30,
2009 are not necessarily indicative of the results to be expected for the full
year. These financial statements should be read in conjunction with deCODEs
Annual Report on Form 10-K for the year ended December 31, 2008,
which includes consolidated financial statements and notes thereto for the
years ended December 31, 2008, 2007 and 2006.
As discussed more fully
in Note 1, deCODE does not have adequate cash flows from operations or,
currently, access to sufficient available capital to meet its requirements for
its 2009 operations. These factors raise significant uncertainty about deCODEs
ability to continue as a going concern. The Consolidated Financial Statements
do not include any adjustments relating to the recoverability or classification
of recorded asset amounts or the amounts or classification of liabilities
should deCODE be unable to continue as a going concern.
3. Revenue
Significant elements of deCODEs revenue are
summarized as follows:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
(In thousands)
|
|
Genomic
services
|
|
$
|
1,418
|
|
$
|
5,120
|
|
$
|
3,320
|
|
$
|
9,996
|
|
Research
funding and other service fees
|
|
18
|
|
236
|
|
62
|
|
464
|
|
Government
research contracts and grant funding
|
|
2,065
|
|
3,600
|
|
4,231
|
|
7,669
|
|
Total
revenue
|
|
$
|
3,501
|
|
$
|
8,956
|
|
$
|
7,613
|
|
$
|
18,129
|
|
Celera
license
. In April 2009, deCODE signed a non-exclusive
worldwide license with Celera for deCODEs genetic markers for increased risk
of major cardiovascular and metabolic diseases, including heart attack, stroke,
atrial fibrillation (AF) and type 2 diabetes (T2D). Under the terms of the
agreements, deCODE received an upfront payment ($10,000,000) and will receive
milestones and royalties on future sales of Celera testing products and
services incorporating deCODE genetic markers. deCODE has determined that the
revenue recognition criteria have not been met and has deferred the recognition
of the $10,000,000 upfront payment to a future period. As such, the $10,000,000
upfront payment is included in long-term deferred revenue on the balance sheet
at June 30, 2009.
deCODEs largest customers as a percentage of
consolidated revenue are as follows:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
United
States National Institutes of Health (NIH)
|
|
30
|
%
|
26
|
%
|
28
|
%
|
28
|
%
|
European
Community (EC)
|
|
26
|
%
|
14
|
%
|
26
|
%
|
14
|
%
|
During the three and
six-month periods ended June 30, 2008, deCODE performed services totaling
$34,000 and $129,000 for employers of members of deCODEs Board of Directors.
6
Table of Contents
4. Cost of Revenue
deCODEs cost of revenue
consists of the costs of services provided to customers and collaborators and
the costs of programs under research contracts and grants, including: (i) the
entirety of the costs incurred in connection with programs that have been
partnered and on which deCODE receives research funding; (ii) costs
associated with other service fee revenues; and (iii) the total amount of
those costs incurred in connection with discovery and development work
performed under research contracts and grants.
Significant elements of deCODEs revenue and cost of
revenue are summarized as follows:
|
|
Three Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
|
|
Revenue
|
|
Cost of
Revenue
|
|
Net
|
|
Revenue
|
|
Cost of
Revenue
|
|
Net
|
|
|
|
(In thousands)
|
|
Genomic services, research funding and other
services
|
|
$
|
1,436
|
|
$
|
1,302
|
|
$
|
134
|
|
$
|
5,356
|
|
$
|
3,557
|
|
$
|
1,799
|
|
Government research contracts and grant funding
|
|
2,065
|
|
3,134
|
|
(1,069
|
)
|
3,600
|
|
4,642
|
|
(1,042
|
)
|
Total
|
|
$
|
3,501
|
|
$
|
4,436
|
|
$
|
(935
|
)
|
$
|
8,956
|
|
$
|
8,199
|
|
$
|
757
|
|
|
|
Six Months Ended June 30,
|
|
|
|
2009
|
|
2008
|
|
|
|
Revenue
|
|
Cost of
Revenue
|
|
Net
|
|
Revenue
|
|
Cost of
Revenue
|
|
Net
|
|
|
|
(In thousands)
|
|
Genomic services, research funding and other
services
|
|
$
|
3,382
|
|
$
|
2,835
|
|
$
|
545
|
|
$
|
10,460
|
|
$
|
7,868
|
|
$
|
2,592
|
|
Government research contracts and grant funding
|
|
4,231
|
|
5,720
|
|
(1,489
|
)
|
7,669
|
|
10,475
|
|
(2,806
|
)
|
Total
|
|
$
|
7,613
|
|
$
|
8,555
|
|
$
|
(944
|
)
|
$
|
18,129
|
|
$
|
18,343
|
|
$
|
(214
|
)
|
5. Research and Development
deCODEs research and
development expense consists of the costs of its own proprietary programs,
comprised of the following:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
(In thousands)
|
|
Salaries
and other personnel costs
|
|
$
|
1,280
|
|
$
|
3,941
|
|
$
|
3,103
|
|
$
|
8,724
|
|
Materials
and supplies
|
|
456
|
|
1,142
|
|
1,091
|
|
4,022
|
|
Contractor
services and other third party costs
|
|
77
|
|
1,084
|
|
513
|
|
3,407
|
|
Overhead
expenses
|
|
400
|
|
956
|
|
862
|
|
2,343
|
|
Depreciation
and amortization
|
|
442
|
|
489
|
|
906
|
|
1,400
|
|
Stock-based
compensation
|
|
186
|
|
352
|
|
397
|
|
682
|
|
Total
|
|
$
|
2,841
|
|
$
|
7,964
|
|
$
|
6,872
|
|
$
|
20,578
|
|
6. Stock-Based Compensation
Stock-based compensation
included in deCODEs results of operations as follows:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
(In thousands)
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
|
Cost
of revenue
|
|
$
|
68
|
|
$
|
52
|
|
$
|
119
|
|
$
|
100
|
|
Research
and development
|
|
186
|
|
352
|
|
397
|
|
682
|
|
Selling,
general and administrative
|
|
300
|
|
491
|
|
699
|
|
1,037
|
|
Total
|
|
$
|
554
|
|
$
|
895
|
|
$
|
1,215
|
|
$
|
1,819
|
|
7
Table of Contents
As of June 30, 2009
there was approximately $4,098,000 of total unrecognized compensation expense
related to nonvested stock options. This expense is expected to be
recognized over a weighted-average period of approximately 1.8 years. There
were no option grants during the six-months ended June 30, 2009.
The following table
summarizes stock option activity for the six-months ended June 30, 2009:
|
|
Number
of Shares
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic Value
|
|
|
|
|
|
|
|
(In years)
|
|
(In thousands)
|
|
Outstanding
at January 1, 2009
|
|
8,453,355
|
|
$
|
5.76
|
|
|
|
|
|
Forfeited/cancelled
|
|
(834,585
|
)
|
5.15
|
|
|
|
|
|
Outstanding
at June 30, 2009
|
|
7,618,770
|
|
$
|
5.83
|
|
6.16
|
|
$
|
0
|
|
Vested
and expected to vest at June 30, 2009
|
|
7,440,112
|
|
$
|
5.89
|
|
6.20
|
|
$
|
0
|
|
Exercisable
at June 30, 2009
|
|
5,844,481
|
|
$
|
6.51
|
|
5.64
|
|
$
|
0
|
|
deCODEs Equity Incentive
Plans allow for the issuance of restricted stock awards that may not be sold or
otherwise transferred until certain restrictions have lapsed. The unearned
stock-based compensation related to these awards is amortized to compensation
expense over the period the restrictions lapse. The stock-based compensation
expense for these awards is determined based on the market price of our stock
at the date of the grant applied to the total numbers of shares that are
anticipated to fully vest and then amortized over the vesting period. At June 30,
2009, deCODE had no unvested restricted shares.
7. Net Loss Per Share
Basic net loss per share is computed using net loss
available to common stockholders and the weighted-average number of common
shares outstanding. The weighted-average number of common shares outstanding
during the period is the number of shares determined by relating the portion of
time within a reporting period that common shares have been outstanding to the
total time in that period.
Diluted net loss per
share is computed using the weighted-average number of common shares
outstanding during the period, plus the dilutive effect of potential common
shares. Diluted net loss per share does not differ from basic net loss per
share in all periods presented as potential common shares are antidilutive for
all such periods and are, therefore, excluded from the calculation. Potential
common shares excluded from the calculation of diluted net loss per share were:
|
|
June 30,
2009
(Shares)
|
|
June 30,
2008
(Shares)
|
|
Warrants
to purchase shares of common stock
|
|
55,556
|
|
455,965
|
|
Options
to purchase shares of common stock
|
|
7,618,770
|
|
8,682,009
|
|
Restricted
shares subject to vesting or with an associated outstanding non-recourse
promissory note
|
|
271,500
|
|
471,092
|
|
Shares
of common stock issuable upon conversion of 3.5% senior convertible notes
|
|
16,428,572
|
|
16,428,572
|
|
|
|
24,374,398
|
|
26,037,638
|
|
8. Comprehensive Loss
Comprehensive income
(loss) generally represents all changes in stockholders equity (deficit)
except those resulting from investments or contributions by stockholders.
Amounts reported in other comprehensive income (loss) include foreign currency
translation adjustments and unrealized gains and losses associated with
investments. The following table presents the calculation of comprehensive
income (loss):
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
(In thousands)
|
|
Net
loss
|
|
$
|
(13,196
|
)
|
$
|
(18,354
|
)
|
$
|
(25,833
|
)
|
$
|
(45,019
|
)
|
Other
comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
Foreign
currency translation
|
|
3
|
|
9
|
|
4
|
|
59
|
|
Unrealized
gain (loss) associated with marketable securities
|
|
1,036
|
|
4
|
|
1,459
|
|
916
|
|
Total
comprehensive loss
|
|
$
|
(12,157
|
)
|
$
|
(18,341
|
)
|
$
|
(24,370
|
)
|
$
|
(44,044
|
)
|
8
Table of Contents
9. Secured Borrowing
In January 2009,
deCODE entered into an agreement with NBI hf., an Icelandic financial
institution, pursuant to which NBI has purchased all auction rate securities (ARS)
owned by deCODE for an aggregate price of ISK 1,375,000,000 (the Purchase
Price), which represented $11,314,000 at the then current currency exchange
rates. NBI has the put option to require deCODE to repurchase the ARS upon the
earlier of (a) the sale of all or a majority of the stock of deCODE
genetics ehf, deCODEs Icelandic subsidiary, (IE) or a specified part of the
operations of IE or (b) December 16, 2009, and deCODE has the call
option to require NBI to sell the ARS to it at any time until January 1,
2010. The repurchase price on exercise of the put or call option (the Repurchase
Price) will be equal to the Purchase Price plus interest from January 16,
2009 at a rate of five percent (5%) above the Reykjavik Interbank Offered Rate
(REIBOR) at the date of the agreement, through the date payment is made less
the aggregate amount of interest and principal received by NBI on the ARS. In
addition, if the aggregate amount of interest and principal received by NBI
with respect to the ARS is higher than the Repurchase Price, upon deCODEs
repurchase of the ARS pursuant to the exercise of the put or call option, NBI
will be required to deliver to deCODE, in addition to the ARS, an amount equal
to (A) the aggregate amount of principal and interest that it received
less (B) the sum of (i) the Repurchase Price and (ii) ISK
375,000,000 (approximately $2,919,000 at June 30, 2009).
Due to the put and call
options, the transfer of the ARS to NBI was accounted for as a secured
borrowing and as such, the ARS remain on deCODEs Consolidated Balance Sheet,
although they are held by NBI, and continue to be carried at fair value. At June 30,
2009, deCODEs Obligation Under the Auction Rate Securities Repurchase Agreement
was $11,664,000 (1,498,505,000 ISK) on
the Consolidated Balance Sheet, which represents deCODEs liability at June 30,
2009 if the put or call right had been exercised to repurchase the ARS. deCODE
recognized interest expense related to the put rights of $556,000 and $992,000
during the three and six-months ended June 30, 2009.
The pledged investments
at June 30, 2009 consist of marketable securities, and are as follows:
|
|
Cost
|
|
Carrying
Value
|
|
Unrealized
Gains (Losses)
In OCI
|
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
June 30, 2009: Auction rate securities
(non-current)
|
|
$
|
33,500
|
|
$
|
13,517
|
|
$
|
1,459
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross unrealized holding
gains and gross unrealized holding losses at June 30, 2009 were $1,459,000
and $0, respectively. There were no unrealized holdings gains or losses at December 31,
2008. The contractual maturity of investments was as follows:
|
|
March 31,
2009
|
|
|
|
(In thousand)
|
|
|
|
|
|
Maturing after 10 years
|
|
$
|
10,637
|
|
No maturity date (perpetual)
|
|
2,880
|
|
|
|
$
|
13,517
|
|
The ARS consist of
private placement securities with long-term nominal maturities for which the
interest rates are reset through a Dutch auction process at pre-determined
calendar intervals, generally each month. This mechanism generally allows
existing investors to rollover their holdings and continue to own their
respective securities or liquidate their holdings by selling their securities
at par value. deCODE generally invested in these securities for short periods
of time as part of its cash management program. However, uncertainties in the
credit markets beginning in 2007 have prevented deCODE and other investors from
liquidating holdings of its ARS in recent auctions because the amount of
securities submitted for sale has exceeded the amount of purchase orders
resulting in multiple failed auctions.
The estimated market value of deCODEs investments in ARS at June 30,
2009 was $13,517,000, which reflects a $19,983,000 adjustment to the original
principal value of $33,500,000. Based on valuation models and an analysis of
other-than-temporary impairment factors, deCODE has recorded an impairment
charge of $120,000 and $663,000 for the three and six-months ended June 30,
2009, respectively, and $1,072,000 and $5,107,000 for the three and six-months
ended June 30, 2008, respectively, in Other non-operating income
(expense), net in the Statements of Operations, reflecting the portion of ARS
holdings that deCODE has concluded have an other-than-temporary decline in
value. deCODE recognized an unrealized gain of $1,036,000 and $1,459,000 in Other
Comprehensive Income during the three and six-months ended June 30, 2009,
respectively. During the six-months ended June 30,
9
Table of
Contents
2008, the
$5,107,000 charge included $914,000 related to ARS which deCODE had previously
believed to be temporary and accounted for as an unrealized loss at December 31,
2007.
The credit and capital
markets have continued to be volatile into 2009. If uncertainties in these
credit and capital markets continue, these markets deteriorate further or
deCODE experiences additional downgrades on its investments, deCODE may incur
additional impairments to its pledged investment portfolio, which could
negatively affect our financial condition, cash flows and reported earnings.
10. Litigation
Other than claims and legal proceedings that arise from time to time in
the ordinary course of business which are not material, and matters described
below, there has been no change in the matters reported in deCODEs Annual
Report on Form 10-K for the year ended December 31, 2008.
On or about April 20, 2002, an amended class action complaint,
captioned
In re deCODE genetics, Inc. Initial Public
Offering Securities Litigation
(01 Civ. 11219(SAS)), alleging
violations of federal securities laws in connection with deCODEs initial
public offering was filed in the United States District Court for the Southern
District of New York (the District Court) on behalf of certain purchasers of
deCODE common stock. The complaint names deCODE, two individuals who were
executive officers of deCODE at the time of its initial public offering (the Individual
Defendants), and the two lead underwriters (the Underwriter Defendants) for
our initial public offering in July 2000 (the IPO) as defendants. deCODE
is aware that similar allegations have been made in hundreds of other lawsuits
filed (many by some of the same plaintiff law firms) against numerous
underwriter defendants and issuer companies (and certain of their current and
former officers) in connection with various public offerings conducted in
recent years. All of the lawsuits that have been filed in the Southern District
of New York have been consolidated for pretrial purposes before United States
District Judge Shira Scheindlin. Pursuant to the underwriting agreement
executed in connection with our IPO, deCODE has demanded indemnification from
the Underwriter Defendants. The Underwriter Defendants have asserted that our
request for indemnification is premature.
Pursuant to an agreement the Individual Defendants have been dismissed
from the case without prejudice.
On July 31, 2003, our Board of Directors (other than our Chairman
and Chief Executive Officer, who recused himself because he was an Individual
Defendant) approved a proposed partial settlement with the plaintiffs in this
matter, subject to a number of conditions, including the participation of a
substantial number of other issuer defendants in the proposed settlement, the
consent of deCODEs insurers to the settlement, and the completion of
acceptable final settlement documentation. A settlement fairness hearing was
held on April 24, 2006. On June 25, 2007, the United States District
Court for the Southern District of New York entered an order formally denying
the motion for final approval of the settlement agreement because the
settlement class could not be certified. On August 14, 2007, the
plaintiffs filed their second consolidated amended class action complaints
against the focus cases and on September 27, 2007, again moved for class
certification. The focus cases are a small group of cases that were selected as
test cases due to the large number of nearly identical actions which were
consolidated in the Initial Public Offering litigation. The court has indicated
that the focus cases are intended to provide strong guidance for the other
cases. The case involving deCODE is not a focus case. On November 12,
2007, certain of the defendants in the focus case moved to dismiss the second
consolidated amended class action complaints. On March 26, 2008, the
District Court denied the motions to dismiss except as to Section 11
claims raised by those plaintiffs who sold their securities for a price in
excess of the initial offering price and those who purchased outside the
previously certified class period. Briefing on the class certification motion
was completed in May 2008. That motion was withdrawn without prejudice on October 10,
2008. On April 2, 2009, a stipulation and agreement of settlement among
the plaintiffs, issuer defendants and underwriter defendants was submitted to
the Court for preliminary approval. The Court granted the plaintiffs motion
for preliminary approval and preliminarily certified the settlement classes on June 10,
2009. The settlement fairness hearing has been scheduled for September 10,
2009. Following the hearing, if the Court determines that the settlement is
fair to the class members, the settlement will be approved and the case against
deCODE and the Individual Defendants will be dismissed with prejudice. There
can be no assurance that this proposed settlement will be approved and
implemented in its current form, or at all. Due to the inherent uncertainties
of litigation and because the settlement approval process is at a preliminary
stage, the ultimate outcome of the matter is uncertain.
While deCODEs expenses in this matter to date have been paid primarily
by its insurers, if deCODE were required to pay significant monetary damages as
a result of an adverse determination in this matter (or any other lawsuits
alleging similar claims filed against deCODE and deCODEs directors and
officers in the future), deCODEs business could be significantly harmed. Even
if such litigation concludes in deCODEs favor, deCODE may be required to
expend significant funds to defend against the allegations. deCODE is unable to
estimate the range of possible loss from this litigation and no amounts have
been provided for it in deCODEs financial statements.
10
Table of Contents
11. Fair Value Measurement
deCODE has used a valuation hierarchy for disclosure of the inputs to
valuation used to measure fair value. This hierarchy prioritizes the inputs
into three broad levels as follows. Level 1 inputs are quoted prices
(unadjusted) in active markets for identical assets or liabilities. Level 2
inputs are quoted prices for similar assets and liabilities in active markets
or inputs that are observable for the asset or liability, either directly or
indirectly through market corroboration, for substantially the full term of the
financial instrument. Level 3 inputs are unobservable inputs based on
assumptions used to measure assets and liabilities at fair value. A financial
asset or liabilitys classification within the hierarchy is determined based on
the lowest level input that is significant to the fair value measurement.
The following table provides the assets and liabilities carried at fair
value measured on a recurring basis as of June 30, 2009:
|
|
|
|
Fair Value
Measurements
at June 30, 3009 Using:
|
|
|
|
Total
Carrying
Value at
June 30,
2009
|
|
Quoted
prices in
active
markets
(Level 1)
|
|
Significant
other
observable
inputs
(Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents money market securities
|
|
$
|
8
|
|
$
|
8
|
|
$
|
|
|
$
|
|
|
Restricted cash and cash equivalents U.S. Treasury
Bills (assets of discontinued operations)
|
|
5,230
|
|
5,230
|
|
|
|
|
|
Auction rate securities (investments non-current)
|
|
13,517
|
|
|
|
|
|
13,517
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents deCODEs changes in assets measured at
fair value on a recurring basis using significant unobservable inputs (Level 3)
at June 30, 2009:
|
|
Auction
Rate Securities
(Pledged Investments)
|
|
|
|
Three
Months
Ended
June 30, 2009
|
|
Six Months
Ended
June 30, 2009
|
|
|
|
(In thousands)
|
|
Balance at beginning of period
|
|
$
|
12,601
|
|
$
|
12,721
|
|
Transfers
to Level 3
|
|
|
|
|
|
Total
gains (losses):
|
|
|
|
|
|
Included
in earnings
|
|
(120
|
)
|
(663
|
)
|
Included
in other comprehensive income
|
|
1,036
|
|
1,459
|
|
Balance
at June 30, 2009
|
|
$
|
13,517
|
|
$
|
13,517
|
|
Valuation
Techniques.
deCODEs i
nvestments in auction rate securities at June 30,
2009 did not have quoted market prices and are classified within Level 3 of the
valuation hierarchy. The valuation models used to value the ARS include those
that are based on expected cash flow streams and collateral values, including
assessments of counterparty credit quality, default risk underlying the
security, discount rates and overall capital market liquidity. The valuation of
deCODEs investments in ARS is subject to uncertainties that are difficult to
predict. Factors that may impact the valuation include changes in credit
ratings of the securities or their guarantors, underlying collateral value,
discounts rates, counterparty risk and ongoing strength and quality of market
credit and liquidity.
The fair value of deCODEs
3.5% convertible notes at June 30, 2009 and December 31, 2008 was
approximately $15,250,000 and $25,744,000, respectively. The fair value of the
convertible notes was based on the most recent quoted market prices at June 30,
2009 and December 31, 2008. The fair values of equipment notes at June 30,
2009 and December 31, 2008 were approximately $206,000 and $334,000,
respectively, as estimated based on quoted market rates for instruments with
similar terms and remaining maturities.
The fair value of
short-term financial instruments, including cash and cash equivalents,
investments, receivables, certain other current assets, trade accounts payable,
certain accrued liabilities, and other current liabilities approximates their
carrying amount in the financial statements due mainly to the short maturity of
such instruments. Based on borrowing rates currently available to deCODE for
capital lease obligations with similar terms, the carrying value of such of its
debt obligations approximates fair value.
12. Discontinued Operations
As part of deCODEs
ongoing strategic review, management and the Board of Directors have been
evaluating and pursuing various alternatives aimed at focusing the companys
long-term business and securing financial resources to fund ongoing product
development and commercialization. The Company plans to sell deCODEs U.S.
subsidiaries.
11
Table of Contents
deCODE has accounted for its U.S. operations as discontinued operations,
and, accordingly, has presented the results of operations and related cash
flows as discontinued operations for all periods presented. The assets and
liabilities of deC
ode
s U.S.
operations to be sold have been been presented separately, and are reflected
within these assets and liabilities from discontinued operations in the
accompanying condensed consolidated balance sheets as of June 30, 2009 and
December 31, 2008.
The summary of the
operating results of the discontinued operations are as follows:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
(In thousands)
|
|
Revenue
|
|
$
|
4,180
|
|
$
|
6,070
|
|
$
|
8,985
|
|
$
|
11,875
|
|
Costs
and expenses
|
|
(4,828
|
)
|
(6,450
|
)
|
(9,734
|
)
|
(12,521
|
)
|
Operating
loss from discontinued operations
|
|
(648
|
)
|
(380
|
)
|
(749
|
)
|
(646
|
)
|
Interest
expense
|
|
(422
|
)
|
(404
|
)
|
(817
|
)
|
(809
|
)
|
Loss
from discontinued operations
|
|
$
|
(1,070
|
)
|
$
|
(784
|
)
|
$
|
(1,566
|
)
|
$
|
(1,455
|
)
|
Assets and
liabilities classified as discontinued operations on deCODEs condensed
consolidated balance sheets are as follows:
|
|
June 30,
2009
|
|
December 31,
2008
|
|
|
|
(In thousands)
|
|
Receivables
|
|
$
|
2,759
|
|
$
|
3,082
|
|
Other
current assets
|
|
781
|
|
846
|
|
Current
assets of discontinued operations
|
|
3,540
|
|
3,928
|
|
Property
and equipment, net
|
|
16,643
|
|
17,304
|
|
Intangible
assets, net
|
|
103
|
|
129
|
|
Restricted
cash and cash equivalents
|
|
5,230
|
|
5,500
|
|
Other
long-term assets
|
|
922
|
|
1,026
|
|
Long-term
assets of discontinued operations
|
|
22,898
|
|
23,959
|
|
Total
assets of discontinued operations
|
|
$
|
26,438
|
|
$
|
27,887
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,740
|
|
$
|
4,909
|
|
Accrued
expenses and other current liabilities
|
|
1,360
|
|
1,897
|
|
Current
portion of long-term debt
|
|
203
|
|
249
|
|
Current
portion of finance obligation
|
|
693
|
|
648
|
|
Deferred
revenue
|
|
385
|
|
874
|
|
Current
liabilities of discontinued operations
|
|
5,381
|
|
8,577
|
|
Finance
obligation
|
|
23,144
|
|
23,497
|
|
Long
term debt, net of current portion
|
|
|
|
75
|
|
Long-term
liabilities of discontinued operations
|
|
23,144
|
|
23,572
|
|
Total
liabilities of discontinued operations
|
|
$
|
28,525
|
|
$
|
32,149
|
|
13. Subsequent Events
On July 30, 2009, deCODEs
stockholders approved the increase in deCODEs number of authorized shares of
common stock from 150,000 to 1,150,000 and also approved the amendment of its
Amended and Restated Certificate of Incorporation to allow for a reverse stock
split at the discretion of deCODEs Board of Directors.
12
Table of Contents
ITEM 2.
MANAGEMENTS DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Managements Discussion
and Analysis of Financial Condition and Results of Operations as of June 30,
2009 and for the three and six-month periods ended June 30, 2009 and 2008
should be read in conjunction with the unaudited condensed consolidated
financial statements and notes thereto set forth in Item 1 of this report.
This quarterly report on Form 10-Q
contains forward-looking statements, including our expectations of future
industry conditions, strategic plans and forecasts of operational results.
Various risks may cause our actual results to differ materially. A list and
description of some of the risks and uncertainties is contained below and in
the summary of risk factors that follow in Part II, Item 1A.
Overview
Headquartered in
Reykjavik, Iceland, deCODE is a biotechnology company developing and marketing
products to improve the treatment, diagnosis and prevention of common diseases.
deCODE employs its discoveries in human genetics to bring to market DNA-based
reference laboratory tests and consumer genome analysis services to assess
individual risk of common diseases, and applies its capabilities to the
development of drugs in major therapeutic areas. As these diseases are common
and there is significant unmet need for both for tools to empower better
prevention as well as for more effective therapies, we believe that our
strategy represents a significant opportunity to create better models for
diagnosis and prevention, leading to improved outcomes with major potential
both near- and longer-term in the global marketplace.
We believe that our
advantage in DNA-based disease risk assessment tests and personal genomics
derives from our population approach to human genetics and the ability to apply
our discoveries directly to product development. We have comprehensive population
resources in Iceland and one of the largest genotyping facilities in the world,
enabling our scientists to effectively identify key variations in the sequence
of the human genome associated with a major impact on individual risk of common
diseases. Well-validated genetic variations conferring risk of disease are the
requisite basis for DNA-based reference laboratory tests and personal genome
scans that can aid in assessing individual risk of disease, and deCODE is a
global leader in the discovery of these genetic risk factors. As virtually all
common diseases have both genetic and environmental risk factors, measuring
genetic risk is in our view a critical component for the realization of
personalized medicine. By providing a more complete understanding of individual
risk, such tests can empower better prevention in those conditions in which
known lifestyle and environmental risk can be modified, as well as targeted
screening and early intervention in major fields such as cardiovascular disease
and cancer. Because we have discovered many major genetic risk factors before
others, and file for intellectual property on our discoveries, we believe that
we are well positioned not only to launch pioneering products but also to
create additional value from our discoveries through partnerships and licensing
agreements.
In the context of limited
financial resources the companys principal focus continues to be on maximizing
near-term value creation. We are pursuing the commercial opportunities coming
out of our gene discovery work, applying these discoveries in our diagnostics
and deCODEme businesses, and for out-licensing agreements such as that we
signed in April 2009 with Celera, Inc., under which we granted
non-exclusive licenses for our genetic markers for increased risk of several
major cardiovascular and metabolic diseases for use in Celeras risk assessment
products and services. At the same time we are seeking to realize revenues from
our existing therapeutics programs through partnerships, out-licensing or
sales, and are employing our drug discovery capabilities to generate contract
service revenue.
At
June 30, 2009, we had cash and cash equivalents
of $3.8 million, compared to $3.7 million at December 31,
2008. In early 2009 deCODE sold its ARS for approximately $11.3 million in
cash, and in April we signed licensing agreements with Celera Corporation
(Celera) under which we received an upfront payment and will receive
royalties on sales of Celera testing products and services incorporating deCODE
genetic risk
markers.
deCODE believes it has sufficient resources
to fund operations only into the latter half of the third quarter. We are
simultaneously pursuing several options to ensure sufficient funding to take it
to the execution of strategic options that can support the near- and
longer-term viability of our core business.
Regardless, deCODEs planned operations require
immediate additional liquidity substantially in excess of the amounts noted
above, raising substantial doubt about deCODEs ability to continue as a going
concern.
In deCODEs ongoing
strategic review, deCODE has been evaluating and pursuing various alternatives
aimed at focusing its business and underpinning ongoing product development and
commercialization in its core business. One likely component of this effort is
the sale of some or all of deCODEs US medicinal chemistry and structural
biology units. Although these units continue to operate and contribute
to deCODE, in view of
their prospective sale the company has accounted for these businesses as discontinued
operations. With the exception of combined net loss figures, the operating
results are thus all for deCODEs continuing operations in its core business of
employing the Companys capabilities in gene discovery to advance DNA-based
diagnostics, personal genome analysis, intellectual property licensing
opportunities, and contract genotyping.
Diagnostics.
We are applying our discoveries and
unique expertise in human genetics and genotyping to the development of
13
Table of Contents
reference laboratory
DNA-based tests for assessing individual risk of a growing range of common
diseases. Since April 2007 we have launched six reference laboratory
DNA-based diagnostic tests to detect single-letter variations in the human
genome (called SNPs) that we have linked to increased risk of several common
diseases:
·
deCODE T2
- which detects SNPs we discovered to be associated with increased risk of type
2 diabetes.
·
deCODE AF
- which detects SNPSs we discovered to be associated with increased risk of
atrial fibrillation and stroke
·
deCODE MI
- which detects SNPs we discovered to be associated with early-onset heart
attack, (myocardial infarction, or MI)
·
deCODE ProstateCancer
- which detects SNPs we have linked to increased risk
of prostate cancer
·
deCODE Glaucoma
-
which detects SNPs we have linked to
increased risk of exfoliation glaucoma
·
deCODE BreastCancer
-
which detects
SNPs we and others have linked to risk of the most common forms of breast
cancer
Beginning in 2008, deCODE initiated billing to
commercial insurance companies on behalf of physicians ordering these tests and
has received reimbursement from many health insurance companies. All of our
diagnostic tests are offered by deCODE via direct sales efforts to physicians
in the United States; through marketing collaborations with other organizations
in the U.S. and other countries; as well as through our dedicated diagnostics
website, www.decodediagnostics.com. deCODE also has an alliance with Illumina, Inc.
under which the companys can develop DNA-based diagnostic kits utilizing
deCODEs gene discoveries in certain diseases and Illuminas platform for SNP
genotyping.
In April 2009, we entered into a non-exclusive
outlicensing agreement with Celera. This
agreement gives Celera the right , on a non-exclusive worldwide basis, to use
markers deCODE has associated with risk of heart attack, atrial
fibrillation/stroke, and type 2 diabetes in Celeras risk assessment products
and services. deCODE is exploring similar opportunities as a pathway to
monetizing the value of its gene discoveries as it continues to extend the
marketing of its own diagnostic products.
deCODEme.
In November 2007, we launched the first consumer
genetic analysis service: deCODEme. This service takes advantage of deCODEs
leadership in human genetics and the capabilities of its high-throughput
genotyping laboratory, which is CLIA registered for analytical and clinical
validation. Through deCODEme, subscribers can put themselves in the context of
the latest discoveries in genetics, learning what their own DNA says about
their ancestry and certain physical traits, as well as whether they have
genetic variants that have been associated with higher or lower than average
risk of a range of common diseases. This information is continually updated as
new discoveries are made, and is presented in subscribers secure individual
web pages. Recently, we launched two focused disease scans, deCODEme Cardio
for cardiovascular-related diseases and deCODEme Cancer for several common
types of cancer. These scans offer subscribers an opportunity to understand
their risk of groups of diseases that may be of particular interest at a more
modest price than the full genome scan. deCODEme products are offered through
a dedicated website, www.decodeme.com.
Drug
Discovery and Development
. Given our focus on furthering our diagnostic business, we are
actively exploring drug development partnerships and out-licensing and sale
opportunities in order to realize revenues from our therapeutics programs. Our
lead drug development programs include:
·
DG041 for the prevention of
arterial thrombosis.
DG041 is our novel, first-in-class antagonist of the EP3 receptor for
prostaglandins E2. DG041 was developed as a next-generation oral anti-platelet
therapy aimed at preventing arterial thrombosis without increasing bleeding
risk, and have taken it through successful Phase II clinical studies.
·
DG051 and DG031 for the
prevention of heart attack.
We have completed Phase I and Phase IIa clinical
studies for DG051, our leukotriene A4 hydrolase (LTA4H) inhibitor being
developed for the prevention of heart attack.
·
DG071 for Alzheimers and other cognitive
disorders
. In October 2008
we filed an investigational new drug (IND) application for DG071, a novel
small-molecule modulator of phosphodiesterase 4 (PDE4), being developed for
Alzheimers and other cognitive disorders.
Our
product portfolio and development pipeline
Over the course of more than a decade we have also
actively studied the genetics and pathology of over 50 different common
diseases using our population genetics approach. We have led the world in the
discovery of variations in the sequence of the human genome conferring risk of
common diseases, and our pioneering DNA-based reference laboratory diagnostic
tests and personal genome scans are based upon these discoveries. Over the past
several years we have discovered and brought into clinical testing several
novel small molecule compounds in major disease areas, compounds we believe
have major therapeutic and commercial potential and which we are now seeking to
bring forward in clinical development through corporate partnerships or to out-license
or sell.
14
Table of Contents
DNA-based
risk-predictive diagnostic tests and consumer genome analysis
Diagnostics represent an important avenue for rapidly
pursuing the medical and commercial value of our genetic discoveries, and since
the beginning of 2007 we have brought to market six DNA-based reference
laboratory tests for measuring individual inherited risk of several common
diseases. We also offer a personal genome analysis service, deCODEme. Because
genetic variants linked to disease are by definition markers of disease
susceptibility, we can apply the same findings we employ in our drug discovery
efforts to the development of DNA-based diagnostic tests. We believe that such
tests may be useful as a means for identifying patients who are at a
particularly high risk of a given disease, and those who are likely to respond
well to drugs that target the same disease pathway.
The key to developing such tests and scans is the
ability to identify common SNPs that confer significant risk of common
diseases. deCODE is a world leader in gene discovery, based upon a unique set
of capabilities and resources the company has assembled in Iceland. These
include a genealogy database linking together the entire current-day population
of Iceland; detailed genetic and medical information from most of the adult
population of Iceland, who are taking part in one or more of our research programs;
genetic and medical data from hundreds of thousands of participants from the
U.S., Europe and around the world; one of the worlds largest high-throughput
genotyping facilities, enabling us to conduct genome-wide association studies
utilizing hundreds of thousands of markers across the genomes of many thousands
of patients and control subjects in each study; and proprietary bioinformatics
and statistical tools to correlate information on disease with specific genetic
variations.
By mining these
datasets our scientists can effectively trace the genetic components of
virtually any common disease, pinpointing key SNPs and genes that confer
increased risk. The companys discoveries are also validated in multiple
populations before they are integrated into our tests and scans. Once we have
replicated our discoveries in several populations we publish them, a process
which enables independent groups to analyze the role of our disease markers in
yet more populations around the world and provides additional information we
can then use to fold back into and expand the utility of our products.
Key new genetic
risk factors for bladder cancer, skin cancer and thyroid cancer, and for lung
cancer and nicotine dependence, are elements in the deCODEme Cancer scan. New
genetic markers for risk of abdominal aortic and intracranial aneurysm and
heart attack have been added to the companys well-established heart attack and
atrial fibrillation/stroke markers in the deCODE MI test and the deCODEme
Cardio scan. All of these discoveries, along with others in bone mineral
density and osteoporosis, obesity, schizophrenia, essential tremor, and asthma,
have provided an unrivalled series of replicated and validated updates for
subscribers of deCODEme.
We believe that
DNA-based diagnostic tests are an important new means for improving disease
prevention, and that they will be used in tandem with existing approaches to
increase the success of prevention efforts. Common diseases occur at the
interface of genetics and the environment, as both inherited as well as
lifestyle and environmental risk factors play important roles in the disease
process. Carrying a genetic risk variant for a common disease does not mean
that one will necessarily develop the disease; and not having a certain risk
variant does not eliminate all risk of developing the disease. Rather, in the
common diseases, genetic risk variants impact the likelihood that one may
develop a given condition. Understanding this inherited risk is empowering
information with potentially important clinical utility, as it is possible to
take preventive action through lifestyle modification or by taking certain
medications to minimize the likelihood of an inherited predisposition ever
developing into a disease. This is similar to the approach that is taken to
address other risk factors for common diseases, such as high cholesterol, which
is commonly treated using statin drugs to lower the risk of heart disease if
dietary change is not enough.
We are actively
marketing and working to secure reimbursement for these tests, even as we
continue to bring new diagnostic products to market. These products are listed
in the table below.
Indication
|
|
Product
|
|
Launch date
|
|
Utility / Highlights
|
Type 2 diabetes
|
|
deCODE T2
|
|
April 2007
|
|
·
High-risk pre-diabetics can receive earlier lifestyle
and pharmacologic intervention
·
Validated in more than 60 populations
|
Atrial fibrillation/stroke
|
|
deCODE AF
|
|
July 2007
|
|
·
Post-stroke/TIA patients at risk of AF to obtain additional
cardiac monitoring
·
Patients with intermittent AF, family history and CHF
to obtain additional cardiac monitoring
·
Validated in more than 10 populations
|
Early-onset heart attack/abdominal aortic aneurysm/intracranial aneurysm
|
|
deCODE MI
|
|
October 2007
|
|
·
Risk of early-onset MI to seek CVD assessment or
prevention management
·
Validated in more than 25 populations
|
Personal genome scan
|
|
deCODEme
|
|
November 2007
|
|
·
Launched with variants in 18 conditions; currently 42
conditions
|
Prostate cancer
|
|
deCODE ProstateCancer
|
|
February 2008
|
|
·
Validated common risk variants that are linked to more
than 50% of all prostrate cancer cases
|
15
Table
of Contents
|
|
|
|
|
|
·
Some variants included identify risk of aggressive
forms of prostrate cancer
·
Validated in more than 15 populations
|
Exfoliation glaucoma
|
|
deCODE Glaucoma
|
|
February 2008
|
|
·
Risk of exfoliation glaucoma
·
Validated in more than 10 populations
|
Breast cancer
|
|
deCODE BreastCancer
|
|
October 2008
|
|
·
Tests 7 genetic risk variants
·
Assesses risk of the most common forms of breast
cancer, which represents 95% of all breast cancers.
·
Validated in more than 10 populations
|
Other DNA-based risk diagnostic tests currently in
development include: melanoma, basal cell cancer, bladder cancer and lung
cancer.
Drug Development Programs
deCODE has
discovered and brought into clinical development several novel compounds in
major disease areas and we are working to realize revenues from these compounds
through corporate partnerships and out-licensing sales. Our most advanced
programs are listed in the following table. Squares indicate the phases in
which at least one clinical trial has been completed.
Therapeutic area
|
|
Compound
|
|
IND
|
|
Phase I
|
|
Phase II
|
|
Phase III
|
Cardiovascular
|
|
|
|
|
|
|
|
|
|
|
Heart attack
|
|
DG051
|
|
n
|
|
n
|
|
Completed Phase Iia
|
|
|
Arterial thrombosis (heart attack, vascular disease)
|
|
DG041
|
|
n
|
|
n
|
|
n
Additional clinical pharmacology studies completed in 2008
|
|
|
Heart attack
|
|
DG031
|
|
n
|
|
n
|
|
n
|
|
Reformulation completed
|
Cognitive
Disorders
|
|
|
|
|
|
|
|
|
|
|
Alzheimers and other cognitive disorders
|
|
DG071
|
|
n
|
|
|
|
|
|
|
DG041
. DG041 is being developed as an anti-platelet
compound for the prevention of arterial thrombosis. DG041 is a first-in-class
small molecule inhibitor of the EP3 receptor for prostaglandin E2, a G-protein
coupled receptor (GPCR). It has been demonstrated by in vitro studies that PGE2
may have additive stimulatory effects on platelet aggregation beyond those of
other potent agonists such as ADP or thromboxane A2, targeted by clopidogrel
and aspirin, respectively.
Structure-based
drug design has also been crucial in our DG041 program. The current mainstays
of anti-thrombotic therapy are compounds that broadly inhibit platelet
activation, with the result that they also cause increased bleeding risk and
are therefore problematic for chronic use. In the discovery of DG041, deCODE
began with a target the EP3 receptor for prostaglandins E2 that the companys
genetics and biology work had identified as a key modulator of arterial
thrombosis. And the use of ligand-based drug design and crystallographic
modeling of the PGE2 bound to EP3 enabled the discovery of DG041 as a very
highly selective inhibitor of EP3.
Based on the
results of our clinical studies thus far, DG041 appears to be well-tolerated,
showing little difference in bleeding events between dosing arms and placebo,
and to potentially offer focused means of preventing the formation of thrombi
by specifically inhibiting platelet aggregation mediated by EP3. In the first
half of 2008, we completed a second clinical pharmacology study examining the
impact of DG041 on top of aspirin and Plavix
TM
,
the results of which show that DG041 blocks platelet aggregation and does not
increase bleeding time when given alone, with Plavix
TM
,
or with Plavix and aspirin.
DG051 and
DG031.
We have
two compounds in development for the prevention of heart attack, DG051 and
DG031. These programs come out of our discovery of major risk variants in two
genes encoding proteins in the leukotriene pathway. These variants in the
genes that code for leukotriene A4 Hydrolase (LTA4H) and 5-lipoxygenase
activating protein (FLAP) appear to confer risk in the same way: by causing
an up regulation in the production of leukotriene B4, a potent pro-inflammatory
molecule that is the end product of one branch of the pathway. The therapeutic
goal of both compounds is to inhibit the activity of the pathway, lowering the
production of LTB4 and thereby decreasing the inflammatory activity in
atherosclerotic plaques and reducing the risk of heart attack. In addition to
reducing the risk of heart attack, these drugs may provide benefit in other
inflammatory diseases.
DG051, discovered internally by deCODEs chemistry
unit, is a small-molecule inhibitor of LTA4H, which is directly involved in the
synthesis of LTB4. In 2007, we completed our Phase I program, the results of
which demonstrated that DG051 was safe and well
16
Table of Contents
tolerated at all doses tested, has a pharmacokinetic
profile suited for potential once-a-day dosing, and significantly reduces LTB4
levels in a concentration-dependent manner. We also concluded a Phase IIa study
in late 2007, which demonstrated safety and tolerability and a significant
reduction in LTB4, even at lower doses than were originally considered. deCODE
also in-licensed a FLAP inhibitor from Bayer AG, now known as DG031. Our Phase
II clinical studies demonstrated that DG031 was well-tolerated and reduced
production of LTB4 in a dose-dependent manner. This effect was seen on top of
the effects of the current standard of care, which included statin therapy for
a majority of patients in our trials.
DG071
. DG071 is a novel, potent and selective PDE4D
modulator discovered by deCODEs chemistry group. First and second generation
PDE4 inhibitors such as rolipram, cilomilast, and roflumilast caused
significant side effects, including nausea and vomiting, at therapeutic doses
in human clinical trials. Such side effects severely limit the utility of these
earlier compounds. Data generated at deCODE suggest that the observed side
effects were closely correlated with the binding of these molecules in the PDE4
enzymatic active site competitively with cAMP. As cAMP is of critical
importance to neuronal signaling, the goal of deCODEs program has been to
discover compounds that would modulate PDE4 activity via an allosteric
mechanism to improve safety and tolerability. Towards this goal, the deCODE
biostructures team solved multiple novel co-crystal structures of PDE4D and
PDE4B containing regulatory domains with bound ligands. Those structures
allowed the deCODE chemistry team to identify a novel binding site for
allosteric modulators in the PDE4 regulatory domain. Binding of an allosteric
modulator at that site is non-competitive with cAMP. DG071 has been shown in
animal models to improve cognitive function with benefit similar to that of
cholinesterase inhibitors such as donepezil that currently are a mainstay of
therapy for memory loss in early Alzheimers disease, yet also benefiting long
term memory function in animal tests where the cholinesterase inhibitors are
ineffective.
The DG071compound is being developed as a new and
potentially safer means of targeting PDE4 to combat memory loss and cognitive
deficits associated with Alzheimers disease and other disorders in which
neural signaling is reduced or impaired. In animal models, DG071 has been shown
to significantly improve learning and long- and short-term memory at doses that
offer a wide margin for safety and tolerability. The compound has the potential
to eliminate the nausea that limits the utility of previous PDE4 inhibitors. In
October 2008 we filed an IND application for DG071.
For our most significant research and development programs we have
cumulatively invested $47.7 million, $24.7 million and $16.0 million in our
heart attack (myocardial infarction, or MI), arterial thrombosis and stroke
programs, respectively, from the beginning of 2003 to date (June 30,
2009). Inception to-date costs are not available as these costs were not
historically tracked by program.
Contract genotyping services
At our research facility in Reykjavik, we have one of
the largest and most advanced genotyping laboratory in the world. We have
extensive expertise in microsatellite genotyping and also conduct genome-wide
single nucleotide polymorphisms (SNP) association analyses. We utilize these
capabilities both for in-house gene discovery work and contract genotyping
services to fee paying customers. We have in place efficient, automated systems
for all stages of the genotyping process, from DNA isolation and amplification
to plate preparation and the generation, storage and analysis of volumes of
genotypic data. Our customers for genotyping services include pharmaceutical
companies, research consortia and academic institutions. Our reference
laboratory is Clinical Laboratory Improvement Act of 1998 as amended (CLIA)
registered.
Results of Operations for the Three and Six-Month
Periods Ended June 30, 2009 and 2008
Our results of operations
have fluctuated from period to period and may continue to fluctuate in the
future based upon, among other things, the pace and progress of our proprietary
research and clinical development efforts, the timing and composition of
funding under our various collaborative agreements, and the progress of our own
research and development efforts. Results of operations for any period may be
unrelated to results of operations for any other period. In addition,
historical results should not be viewed as indicative of future operating
results. We are subject to risks common to companies in our industry and at our
stage of development, including risks inherent in our research and development
efforts, reliance upon collaborative partners, development by us or our
competitors of new technological innovations, ability to market products or
services, dependence on key personnel, dependence on key suppliers, protection
of proprietary technology, ability to obtain additional financing, ability to
negotiate collaborative arrangements, and compliance with governmental and other
regulations. In order for a drug to be commercialized based on our research, we
and our collaborators must conduct pre-clinical tests and clinical trials,
demonstrate the efficacy and safety of our product candidates, obtain
regulatory approvals or clearances and enter into manufacturing, distribution
and marketing arrangements, as well as obtain market acceptance. We do not
expect to receive significant revenues or royalties based on therapeutic or
diagnostic products for a period of years, if at all.
In
deCODEs ongoing strategic review, deCODE has been evaluating and pursuing
various alternatives aimed at focusing its business and underpinning ongoing
product development and commercialization in its core business. One component
of this effort is the sale of deCODEs US medicinal chemistry and structural
biology subsidiaries. Although these subsidiaries continue to operate and
contribute to the results and cash flows of deCODE, in view of their
prospective sale and in accordance with SFAS No. 144,
Accounting
for the Impairment or Disposal of Long-lived Assets
,
deCODE has accounted for
these businesses as discontinued operations. The operating results presented
here are thus for deCODEs core business of employing the Companys
capabilities in gene discovery
17
Table of Contents
to advance DNA-based
diagnostics, personal genome analysis, intellectual property licensing
opportunities, and contract genotyping.
The assets and
liabilities of deCODEs U.S. operations to be sold have been been presented
separately, and are reflected within these assets and liabilities from
discontinued operations in the accompanying condensed consolidated balance
sheets as of June 30, 2009 and December 31, 2008.
deCODE also continues to be engaged in
negotiations on several other strategic opportunities including the sale of
therapeutic programs; licensing agreements for certain of our diagnostics
tests; entering large-scale genome sequencing collaborations; restructuring its
debt; and obtaining new equity financing.
Financial highlights as
of and for the three and six-month periods ended June 30, 2009 include:
·
We incurred a loss of $13.2 million and
$25.8 million during the three and six-months ended June 20, 2009 and used
cash in operating activities of $9.4 million and $38.0 million during the
six-months ended June 30, 2009 and 2008, respectively. We incurred a loss
of $80.9 million and used cash of $54.8 million in operating activities in the
year ended December 31, 2008.
At June 30, 2009, we
had cash and cash equivalents
of $3.8 million, compared to $3.7 million at December 31, 2008.
In early 2009 deCODE sold its ARS for approximately $11.3 million in cash, and
in April we signed licensing agreements with Celera under which we
received an upfront payment of $10.0 million and will receive royalties on
sales of Celera testing products and services incorporating deCODE genetic risk
markers.
We believe we have sufficient resources to fund operations only into the
latter half of the third quarter. We are simultaneously pursuing several
options to ensure sufficient funding to take us to the execution of strategic options
that can support the near- and longer-term viability of our core business.
Our planned operations require immediate
additional liquidity substantially in excess of the amounts noted above,
raising substantial doubt about our ability to continue as a going concern.
·
Our revenue was $3.5 million and $7.6
million for the three and six-months ended June 30, 2009 as compared to $9.0
million and $18.1 million during the three and six-month periods ended June 30,
2008. As of June 30, 2009, we had $21.3 million in deferred revenue that
will be recognized over future reporting periods. The period-on-period decrease
in revenue for the three and six months ended June 30, 2009 as compared to
the same periods in 2008 is primarily due to decreased genomic services and
government research contracts and grant funding.
·
Our research and development expense was
$2.8 million and $6.9 million for the three and six-month periods ended June 30,
2009 as compared to $8.0 million and $20.6 million for the three and six-month
periods ended June 30, 2008.
These figures reflect our current
focus on controlling costs in core genetics activities creating intellectual
property and novel content for our diagnostic tests, deCODEme scans, and
outlicensing opportunities.
·
Our selling, general and administrative expense was
$4.3 million and $8.6 million during the three and six-month periods ended June 30,
2009 as compared to $5.9 million and $11.7 million during the three and
six-month periods ended June 30, 2008. The changes in selling, general and
administrative expense period-on-period are primarily due to lower overall
headcount in 2009 versus 2008 as well as decreased contractor and legal
expenses.
·
In January 2009 we entered into an
agreement with an Icelandic financial institution (NBI hf) pursuant to which
NBI has purchased all auction rate securities (ARS) owned by deCODE for an
aggregate price of $11.3 million at exchange rates at the date of the
transaction. The agreement includes both call and put rights under certain
instances and which expire at the end of 2009. The transaction was accounted
for as a secured borrowing with the ARS remaining on our balance sheet and as a
result we recognized a liability for the borrowing ($11.7 million at June 30,
2009) which represents the amount we would be required to pay should we
exercise our call right to repurchase the ARS or should we be required to
repurchase the ARS in the event of a sale of Icelandic assets or if exercised
by NBI hf on December 16, 2009.
Revenue
|
|
Three Months
|
|
Six Months
|
|
2009 as Compared to 2008
|
|
|
|
Ended June 30,
|
|
Ended June 30,
|
|
Three Months
|
|
Six Months
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
$ Change
|
|
% Change
|
|
$ Change
|
|
% Change
|
|
|
|
(In thousands, except %)
|
|
Revenue
|
|
$
|
3,501
|
|
$
|
8,956
|
|
$
|
7,613
|
|
$
|
18,129
|
|
$
|
(5,445
|
)
|
(61
|
)%
|
$
|
(10,516
|
)
|
(58
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In 2008 and into 2009 our business strategy has
focused on emphasizing our core capabilities in human genetics and leveraging
those strengths to build on opportunities to generate near-term revenue from
products that we already have available; namely our genomic services comprising
diagnostics, our consumer genetics service deCODEme and genotyping services. At
the same time, we seek to realize revenue from our early and late stage drug
programs through corporate partnerships, out-licensing and sales and will
generate revenue from contract and other service fees. Further, we will
continue to leverage our capabilities to continue with and
18
Table
of Contents
pursue funding in the form of research grants. In the majority of our
programs we are pursuing diagnostic and early-stage drug development on our
own. Depending on the nature of each prospective business opportunity, the key
components of the commercial terms of the types of collaborations we seek
typically include one or more of the following: research funding; up-front, exclusivity,
technology access, and technology development fees; fees for particular
services; milestone payments; license or commercialization fees; and royalties
or profit sharing from the commercialization of products.
Significant elements of
our revenue are summarized as follows:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
(In thousands)
|
|
Genomic
services
|
|
$
|
1,418
|
|
$
|
5,120
|
|
$
|
3,320
|
|
$
|
9,996
|
|
Research
funding and other service fees
|
|
18
|
|
236
|
|
62
|
|
464
|
|
Government
research contracts and grant funding
|
|
2,065
|
|
3,600
|
|
4,231
|
|
7,669
|
|
Total
revenue
|
|
$
|
3,501
|
|
$
|
8,956
|
|
$
|
7,613
|
|
$
|
18,129
|
|
The period-on-period
decrease in revenue for the three and six-months ended June 30, 2009 as
compared to the same periods in 2008 is primarily due to decreased genomic
services and government research contracts and grant funding.
At June 30, 2009 we had $21.3 million in deferred
revenue, compared to $11.1 million at December 31, 2008. Of this
deferred revenue, $6.2 million relates to our agreement with Merck and $10.0
million relates to our agreement with Celera. Our agreement with Merk is to
conduct information-rich clinical trials in Iceland and, to date, Merck has not
selected any compounds for development under the agreement. Under the terms of
the agreement with Celera we received an upfront payment ($10.0 million) and
will receive milestones and royalties on future sales of Celera testing
products and services incorporating deCODE genetic markers. The Company has
determined that the revenue recognition criteria have not been met and has
deferred the recognition of the $10.0 million upfront payment to a future
period. We expect that our revenues will fluctuate from period to period and
that such fluctuations may be substantial especially because progress in our
scientific work, including milestone payments that are related to progress, can
fluctuate between periods.
Government Research Contracts and
Grant Funding.
We
have received various research grants from divisions of the United States
National Institutes of Health (NIH), the Commission of the European Communities
(EC) and other government agencies and private foundations. Research grants for
multiple years are based on approved budgets with budgeted amounts subject to
approval on an annual basis. NIH grants generally provide for 100%
reimbursement of allowable expenditures while grants under the EC generally
provides for fifty percent reimbursement of allowable research and development related expenditures. Our most
significant research contract is with the National Institutes of Allergy and
Infectious Diseases (NIAID) dating to September 2004, where we were
awarded a five-year $23.9 million contract by the NIAID. Under the contract, we
are applying our population approach and resources to discover genetic factors
associated with susceptibility to certain infectious diseases and with
responsiveness to vaccines targeting such diseases. We may receive $3.9 million
in additional research funding over the remaining term of the agreement.
Cost of Revenue
|
|
Three Months
|
|
Six Months
|
|
2009 as Compared to 2008
|
|
|
|
Ended June 30,
|
|
Ended June 30,
|
|
Three Months
|
|
Six Months
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
$ Change
|
|
% Change
|
|
$ Change
|
|
% Change
|
|
|
|
(In thousands, except %)
|
|
Cost
of revenue
|
|
$
|
4,436
|
|
$
|
8,199
|
|
$
|
8,555
|
|
$
|
18,343
|
|
$
|
(3,763
|
)
|
(46
|
)%
|
$
|
(9,788
|
)
|
(53
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our cost of revenue
consists of the costs of services provided to customers and collaborators and
the costs of programs under research contracts and grants, including: (i) the
entirety of the costs incurred in connection with programs that have been
partnered and on which we receive research funding; (ii) costs associated
with other service fee revenues; and (iii) the total amount of those costs
incurred in connection with discovery and development work performed under
research contracts and grants. At times, we invest in addition to costs covered
by research funding received in such collaborative programs and in addition to
monies received under research contracts and grants.
19
Table of Contents
Significant elements of deCODEs revenue and cost of
revenue are summarized as follows:
|
|
Three Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
|
|
Revenue
|
|
Cost of
Revenue
|
|
Net
|
|
Revenue
|
|
Cost of
Revenue
|
|
Net
|
|
|
|
(In thousands)
|
|
Genomic services, research funding and other
services
|
|
$
|
1,436
|
|
$
|
1,302
|
|
$
|
134
|
|
$
|
5,356
|
|
$
|
3,557
|
|
$
|
1,799
|
|
Government research contracts and grant funding
|
|
2,065
|
|
3,134
|
|
(1,069
|
)
|
3,600
|
|
4,642
|
|
(1,042
|
)
|
Total
|
|
$
|
3,501
|
|
$
|
4,436
|
|
$
|
(935
|
)
|
$
|
8,956
|
|
$
|
8,199
|
|
$
|
757
|
|
|
|
Six Months Ended June 30,
|
|
|
|
2009
|
|
2008
|
|
|
|
Revenue
|
|
Cost of
Revenue
|
|
Net
|
|
Revenue
|
|
Cost of
Revenue
|
|
Net
|
|
|
|
(In thousands)
|
|
Genomic services, research funding and other
services
|
|
$
|
3,382
|
|
$
|
2,835
|
|
$
|
545
|
|
$
|
10,460
|
|
$
|
7,868
|
|
$
|
2,592
|
|
Government research contracts and grant funding
|
|
4,231
|
|
5,720
|
|
(1,489
|
)
|
7,669
|
|
10,475
|
|
(2,806
|
)
|
Total
|
|
$
|
7,613
|
|
$
|
8,555
|
|
$
|
(944
|
)
|
$
|
18,129
|
|
$
|
18,343
|
|
$
|
(214
|
)
|
Decreases in our cost of
revenue for the three and six-months ended June 30, 2009 as compared to
the same periods in 2008 are largely on account of overall decreased revenue,
specifically (i) the decrease of our genomics business, principally the
decrease of contract genotyping services and (ii) a decreased amount of
discovery and development work performed under ongoing contracts and grants
with the NIH and EC. Our cost of revenue in the three and six-month periods
ended June 30, 2009 as compared to the same periods in 2008 decreased
chiefly with regard to our usage of chemicals and consumables ($2.0 million and
$4.9 million, respectively) and also decreased salaries ($1.1 million and $2.7
million, respectively) due to lower headcount and decreased contractor services
and other overhead ($0.8 million and $2.0 million, respectively).
Research and Development
|
|
Three Months
|
|
Six Months
|
|
2009 as Compared to 2008
|
|
|
|
Ended June 30,
|
|
Ended June 30,
|
|
Three Months
|
|
Six Months
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
$ Change
|
|
% Change
|
|
$ Change
|
|
% Change
|
|
|
|
(In thousands, except %)
|
|
Research
and development
|
|
$
|
2,841
|
|
$
|
7,964
|
|
$
|
6,872
|
|
$
|
20,578
|
|
$
|
(5,123
|
)
|
(64
|
)%
|
$
|
(13,706
|
)
|
(67
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our research and development expense consist of the
following:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
(In thousands)
|
|
Salaries
and other personnel costs
|
|
$
|
1,280
|
|
$
|
3,941
|
|
$
|
3,103
|
|
$
|
8,724
|
|
Materials
and supplies
|
|
456
|
|
1,142
|
|
1,091
|
|
4,022
|
|
Contractor
services and other third party costs
|
|
77
|
|
1,084
|
|
513
|
|
3,407
|
|
Overhead
expenses
|
|
400
|
|
956
|
|
862
|
|
2,343
|
|
Depreciation
and amortization
|
|
442
|
|
489
|
|
906
|
|
1,400
|
|
Stock-based
compensation
|
|
186
|
|
352
|
|
397
|
|
682
|
|
Total
|
|
$
|
2,841
|
|
$
|
7,964
|
|
$
|
6,872
|
|
$
|
20,578
|
|
Our research and
development expense for 2009 and 2008 reflects the advancement of our drug and
diagnostic programs, including costs related to the development and launch of
our latest DNA-based diagnostic tests for gauging individual risk of a growing
number of common disease and ongoing
gene discovery work that is feeding our diagnostic pipeline and our deCODEme
service offerings. We also continued to pursue our PDE4 modulator program
across several indications and filed an IND for DG071 in October 2008.
With near-term value creation in mind, our core focus in 2008 and into 2009 has
been towards building our diagnostics and deCODEme businesses and our genomic
services broadly. With that focus in mind and continued decreased clinical
trial work in 2009, we experienced decreased overall expense in 2009.
20
Table
of Contents
Selling, General and Administrative Expense
|
|
Three Months
|
|
Six Months
|
|
2009 as Compared to 2008
|
|
|
|
Ended June 30,
|
|
Ended June 30,
|
|
Three Months
|
|
Six Months
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
$ Change
|
|
% Change
|
|
$ Change
|
|
% Change
|
|
|
|
(In thousands, except %)
|
|
Selling,
general and administrative
|
|
$
|
4,318
|
|
$
|
5,929
|
|
$
|
8,582
|
|
$
|
11,678
|
|
$
|
(1,611
|
)
|
(27
|
)%
|
$
|
(3,096
|
)
|
(27
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in
our selling, general and administrative expense for the three and six-month
periods ended June 30, 2009 compared to the same periods in 2008 is
principally attributable to decreased salary and stock-based compensation ($1.0
million and $2.0 million respectively) due to lower head-count and lower travel
costs ($0.4 million and $0.7 million, respectively).
Interest Expense
|
|
Three Months
|
|
Six Months
|
|
2009 as Compared to 2008
|
|
|
|
Ended June 30,
|
|
Ended June 30,
|
|
Three Months
|
|
Six Months
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
$ Change
|
|
% Change
|
|
$ Change
|
|
% Change
|
|
|
|
(In thousands, except %)
|
|
Interest
expense
|
|
$
|
4,380
|
|
$
|
3,716
|
|
$
|
8,611
|
|
$
|
7,336
|
|
$
|
664
|
|
18
|
%
|
$
|
1,275
|
|
17
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our interest
expense is primarily attributable to interest on our 3.5% Senior Convertible
Notes due in 2011 for which our cash interest payments are approximately $8.1
million on an annual basis.
In January 2009 we transferred our auction rate
securities to an Icelandic financial institution which was accounted for as a
secured borrowing due to the put and call rights. During the three and
six-months ended June 30, 2009, we recognized $0.6 million and $1.0
million of interest expense related to this secured borrowing.
Other non-operating income and
(expense), net
|
|
Three Months
|
|
Six Months
|
|
2009 as Compared to 2008
|
|
|
|
Ended June 30,
|
|
Ended June 30,
|
|
Three Months
|
|
Six Months
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
$ Change
|
|
% Change
|
|
$ Change
|
|
% Change
|
|
|
|
(In thousands, except %)
|
|
Other
non-operating income and (expense), net
|
|
$
|
330
|
|
$
|
(1,170
|
)
|
$
|
565
|
|
$
|
(5,247
|
)
|
$
|
1,500
|
|
128
|
%
|
$
|
5,812
|
|
111
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We recognized an
other-than-temporary loss on investments in auction rate securities (ARS)
classified as non-current investments on our balance sheet at June 30,
2009 and 2008 of $0.1 million and $0.7 million during the three and six-months
ended June 30, 2009, respectively, and $1.1 million and $5.1 million for
the three and six-months ended June 30, 2008, respectively. For the three
and six-months ended June 30, 2009, this impairment related to the ARS was
offset by $0.5 million and $0.6 million, respectively, related to foreign
currency translation gains due primarily to the change in valuation of the
Icelandic krona versus the U.S. dollar. For the three and six-months ended June 30,
2008, the ARS impairment charge included $0.9 million of impairment determined
to be temporary at December 31, 2007. If uncertainties in these credit and
capital markets continue, these markets deteriorate further or we experience
additional downgrades on our investments, we may incur additional impairments
to our investment portfolio, which could negatively affect our financial
condition, cash flows and reported earnings.
Liquidity
and Capital Resources
Financial
Condition
. Our planned operations require immediate
additional liquidity which may not be available, raising substantial doubt
about our ability to continue as a going concern. Our cash used in operations
have been $9.4 million and $38.0 million for the six-months ended June 30,
2009 and 2008, respectively and $54.8 million for the year ended December 31,
2008. In addition, the Company has significant amounts of long-term debt which
requires interest payments of approximately $8.1 million per annum. At June 30,
2009, we had liquid funds available (cash and cash equivalents) of $3.8 million
as compared to $3.7 million at December 31, 2008. In January 2009 we
transferred our ARS to an Icelandic financial institution for an aggregate
price of approximately $11.3 million. In April 2009, we signed a
non-exclusive worldwide license with Celera Corporation (Celera) for our
genetic markers for increased risk of major cardiovascular and metabolic
diseases, including heart attack, stroke, atrial fibrillation (AF) and type 2
diabetes (T2D). Under the terms of the agreement we received an upfront payment
of $10.0 million, which was received in April 2009.
21
Table of Contents
To address deCODEs immediate need for funds, management and the Board of
Directors are exploring the possibilities of (i) selling some or all of
deCODEs U.S. subsidiaries, (ii) granting further licenses to specific
diagnostic products, (iii) entering into a collaboration for gene
sequencing, (iv) selling or out-licensing some or all of deCODEs clinical
and pre-clinical drug discovery programs, (v) restructuring deCODEs
outstanding convertible notes and (vi) obtaining new equity
financing. Achieving (v) could
result in a settlement of deCODEs convertible note obligation for
substantially less than the carrying amount or in either a cash conversion of
the convertible notes into equity of deCODE. Receipt of additional equity
financing to support operations in the longer term depends in large part on the
outcomes of actions in (i), (ii), (iii) and (v). Management and the board
are having ongoing dialogues and negotiations with third parties in each of
these areas.
If deCODEs Board of
Directors concludes that any of these options can be better implemented in a
bankruptcy proceeding, deCODE will commence a proceeding under Chapter 11 of
the U.S. Bankruptcy Code. Whether in a bankruptcy proceeding or otherwise, the
consummation of any of these approaches are dependent on successful
negotiations with third parties and in many cases the availability of financing
to such third parties. There can be no asssurance that any potential
transactions will be consummated or will result in sufficient funding to
sustain operations.
deCODE believes it has sufficient resources to fund
operations only into the latter half of the third quarter. It is simultaneously
pursuing several options to ensure sufficient funding to take it to the
execution of strategic options that can support the near- and longer-term
viability of its core business.
In deCODEs ongoing
strategic review, deCODE has been evaluating and pursuing various alternatives
aimed at focusing its business and underpinning ongoing product development and
commercialization in its core business. One likely component of this effort is
the sale of some or all of deCODEs US medicinal chemistry and structural
biology units. Although these units continue to operate and contribute
to deCODE, in view of
their prospective sale the company has accounted for these businesses as discontinued
operations (see Note 12). With the exception of combined net loss figures, the
operating results are thus all for deCODEs continuing operations in its core
activities in gene discovery and its related businesses, including DNA-based
risk assessment tests, personal genome scans, intellectual property licensing,
and contract genotyping.
We have financed our
operations primarily through funding from research and development
collaborative agreements, and the issuance of equity securities and long-term
financing instruments ($1,088 million from the beginning of 1999 to June 30,
2009). At June 30, 2009, future funding under terms of our existing
agreements is approximately $36.8 million (excluding milestone payments,
royalties and other payments that we may earn under such collaborations, and
excluding our discontinued operations and including $19.0 million from
discontinued operations), for which significant expense will need to be
incurred in order to earn this revenue. Of the $36.8 million, approximately
$23.8 million (which includes $15.8 million from discontinued operations) is
expected to be received during the year ending December 31, 2009, with the
remaining amount due through 2012.
Icelandic
Economic Situation.
deCODE has significant operations in Iceland and pays a large proportion of its
fixed costs in Icelandic Krona (ISK), while its sales are generally denominated
in U.S. dollars and its reporting currency is the U.S. dollar. Beginning in the
third quarter of 2008 and particularly in the first weeks of the fourth
quarter, the effects of the global credit and financial crisis hit the
Icelandic economy particularly hard. In mid-October 2008, the Icelandic
parliament passed emergency legislation to minimize the impact of the financial
crisis, resulting in the government takeover of the three largest Icelandic
banks. By the end of October, with significant foreign exchange controls in
place, the official exchange rate was 120.6 ISK to the U.S. dollar. The ISK
fell from 62 ISK to the U.S. dollar on January 1, 2008 to 123 ISK to the
U.S. dollar on December 31, 2008 and was 120 ISK to the U.S. dollar on June 30,
2009. The turmoil in the Icelandic financial sector and economy as a whole has
not had a significant impact on deCODE and has had no material adverse impact
on our day to day operations, except to decrease the dollar value of our
ISK-denominated costs. At June 30, 2009, deCODE has ISK denominated
operating lease obligations of $37.6 million, ISK denominated put rights
related to our ARS of $11.7 million and cash and cash equivalents denominated
in ISK of $0.1 million. Our most significant operating expenses denominated in
ISK include salaries and rental payments on our leased facilities and capital
equipment leases and we expect that in as far as the ISK decreases in value
versus the U.S. dollar our ISK-denominated operating expenses will generally
decrease.
Fair
Value.
As of June 30,
2009, we have certain assets recorded at fair value. In accordance with
Statement of Financial Accounting Standards No. 157,
Fair Value
Measurement
, or SFAS No. 157, we have classified our financial
assets as Level 1, 2 or 3 within the fair value hierarchy. Fair values
determined by Level 1 inputs utilize quoted prices (unadjusted) in active
markets for identical assets or liabilities. Fair values determined by Level 2
inputs utilize quoted prices for similar assets and liabilities in active
markets or inputs that are observable for the asset or liability, either
directly or indirectly through market corroboration, for substantially the full
term of the financial instrument. Fair values determined by Level 3 inputs
utilize unobservable inputs based on assumptions used to measure assets and
liabilities at fair value. A financial asset or liabilitys classification
within the hierarchy is determined based on the lowest level input that is
significant to the fair value measurement.
As noted in Note 9 to our
consolidated financial statements, a majority of our financial assets consist
of auction rate securities (ARS) and have been classified as Level 3 in the
fair value hierarchy. These assets are pledged to an Icelandic financial
institution as of June 30, 2009 related to our secured borrowing. The
pledged ARS consist of private placement securities with long-term nominal
maturities for which the interest rates are reset through a Dutch auction
process at pre-determined calendar intervals, generally each month. This
mechanism generally allowed existing investors to rollover their holdings and
continue to own their respective securities or liquidate their holdings by
selling their securities at par value. We generally invested in these
securities for short periods of time as part of our cash management program.
However, the ongoing uncertainties in the credit markets prevented us and other
investors from liquidating holdings of our remaining ARS in recent auctions for
these securities because the amount of securities submitted for sale
22
Table of Contents
has exceeded the amount
of purchase orders and this has resulted in multiple failed auctions. The
pledged ARS at June 30, 2009, represent interests in debt obligations,
namely life insurance wrapped issues, of companies offering credit derivatives,
and of entities on which monoline insurers retain capital put rights. The
remaining ARS investments were generally collateralized by pools of commercial
paper, investment-grade corporate debt, asset and mortgage-backed securities,
government and money-market issues and other ARS.
Our Level 3 investments
in ARS have a present lack of observable market quotes. The valuation models
used to value the securities include those that are based on expected cash flow
streams and collateral values, including assessments of counterparty credit
quality, default risk underlying the security, discount rates and overall
capital market liquidity. The valuation of our investments in ARS is subject to
uncertainties that are difficult to predict. Factors that may impact the
valuation include changes in credit ratings of the securities or their
guarantors, underlying collateral value, discounts rates, counterparty risk and
ongoing strength and quality of market credit and liquidity. We validate the
prices provided by our third party pricing service by understanding the models
used and challenging pricing data in certain instances.
As previously noted, in January 2009 we entered into an agreement
with an Icelandic financial institution (NBI hf) pursuant to which NBI has
purchased all auction rate securities (ARS) owned by deCODE for an aggregate
price of approximately $11.3 million. The agreement includes both call and put
rights under certain instances and which expire at the end of 2009. The
estimated market value of our pledged non current investments in ARS at June 30,
2009 was $13.5 million. Based on valuation models and an analysis of
other-than-temporary impairment factors, deCODE has recorded an impairment
charge of $0.7 million and $5.1 million for the six-months ended June 30,
2009 and 2008, respectively, in Other non-operating income (expense), net in
the Statements of Operations, reflecting the portion of ARS holdings that
deCODE has concluded have an other-than-temporary decline in value. deCODE
recognized an unrealized gain of $1.5 million in Other Comprehensive Income
during the six-months ended June 30, 2009. During the six-months ended June 30,
2008, the $5.1 million charge included $0.9 million related to ARS which deCODE
had previously believed to be temporary and accounted for as an unrealized loss
at December 31, 2007.
Our cash was provided by and used as follows:
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
|
|
(In thousands)
|
|
Cash provided by (used in):
|
|
|
|
|
|
Operating activities
|
|
$
|
(9,441
|
)
|
$
|
(37,982
|
)
|
Investing activities
|
|
74
|
|
3,730
|
|
Financing activities
|
|
9,431
|
|
(1,682
|
)
|
Cash and cash equivalents, at end of period
|
|
3,765
|
|
18,238
|
|
|
|
|
|
|
|
|
|
Cash
and Cash Equivalents.
At June 30, 2009 we had $3.8 million in cash and cash
equivalents compared to $3.7 million at December 31, 2008. Utilization of
our cash resources in 2009 is principally owing to cash used in product
development, research and general operations as reflected in the $9.4 million
cash we used in operations.
Operating
Activities.
Net
cash used in operating activities decreased to $9.4 million in 2009 as compared
to $38.0 million in 2008. Cash used in our operations is principally owing
to cash used in diagnostic and therapeutic product development, research and
general operations as reflected in the $9.4 million cash we used in operations,
as more fully described above; most importantly attributable to our focus on
applying our established capabilities in human genetics to drive our
diagnostics and deCODEme businesses.
Investing
Activities.
Our
investing activities have consisted of short-term investments in marketable
securities and capital expenditures. Capital expenditures have been principally
replacement capital expenditures during 2009 and we anticipate making only
necessary replacement capital expenditures in the near term.
Financing
Activities.
Net
cash of $9.4 million was provided by financing activities in 2009 as compared
to $1.7 million used in financing activities in 2008. As previously noted, in January 2009
we entered into an agreement with an Icelandic financial institution (NBI hf)
pursuant to which NBI has purchased all auction rate securities (ARS) owned
by us for an aggregate price of approximately $11.3 million. The agreement
includes both call and put rights under certain instances and which expire at
the end of 2009. Financing activities for 2008 consisted primarily of ongoing
repayment of and installment payments on debt, capital lease and finance
obligations ($1.5 million)
.
Contractual
Commitments and Off-Balance Sheet Arrangements.
The following
summarizes our contractual obligations at June 30, 2009, and the effects
such obligations are expected to have on our liquidity and cash flows in future
periods:
23
Table of
Contents
|
|
|
|
Payments Due by Period
|
|
|
|
Total
|
|
Less Than
1 Year
|
|
1 2 Years
|
|
2 3 Years
|
|
3 4 Years
|
|
4 5 Years
|
|
More Than
5 Years
|
|
|
|
(In thousands)
|
|
3.5%
Senior convertible notes, including interest
|
|
$
|
246,100
|
|
$
|
8,050
|
|
$
|
238,050
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Long-term
debt, including interest (3)
|
|
213
|
|
213
|
|
|
|
|
|
|
|
|
|
|
|
Capital
lease obligations, including interest
|
|
748
|
|
748
|
|
|
|
|
|
|
|
|
|
|
|
Finance
obligation, including interest (3)
|
|
36,732
|
|
2,059
|
|
2,111
|
|
2,164
|
|
2,218
|
|
2,273
|
|
25,907
|
|
Operating
leases (1) (4)
|
|
38,366
|
|
3,777
|
|
3,696
|
|
3,678
|
|
3,582
|
|
3,487
|
|
20,146
|
|
Secured
debt collateralized by ARS (2)
|
|
11,664
|
|
11,664
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
333,823
|
|
$
|
26,511
|
|
$
|
243,857
|
|
$
|
5,842
|
|
$
|
5,800
|
|
$
|
5,760
|
|
$
|
46,053
|
|
(1)
Balance includes $37.6 million of Icelandic krona
(ISK) denominated lease obligations which are variable based on the exchange
rate of the ISK versus the U.S. dollar and also this amount is subject to
periodic adjustments based on the Icelandic Consumer Price Index (ICPI). A
hypothetical 10% increase or decrease in the ISK and U.S. dollar exchange rate
would result in an increase or decrease of our annual lease payments of $0.3
million. A hypothetical 100 basis point increase of the ICPI would result in an
increase or decrease of our annual lease payments of $0.1 million.
(2)
Balance represents the put and call rights related to
a secured borrowing and is denominated in ISK which is variable based on the
exchange rate of the ISK versus the U.S. dollar and also this amount will
increase each period through the end of 2009 due to fixed interest related to
these put and call rights. A hypothetical 10% increase or decrease in the ISK
and U.S. dollar exchange rate would result in an increase or decrease of the
value of this balance by $1.7 million.
(3)
Balance represents commitments related to our U.S.
operations which are classified as discontinued operations at June 30,
2009.
(4)
Balance includes $0.7 million of commitments related
to our U.S. operations which are classified as discontinued operations at June 30,
2009.
In January 2009,
deCODE entered into an agreement with NBI hf., an Icelandic financial
institution, pursuant to which NBI has purchased all auction rate securities (ARS)
owned by deCODE for an aggregate price of ISK 1,375,000,000, which represented
$11.3 million at the then current currency exchange rates. NBI has the put
option to require deCODE to repurchase the ARS upon the earlier of (a) the
sale of all or a majority of the stock of deCODE genetics ehf, deCODEs
Icelandic subsidiary, (IE) or a specified part of the operations of IE or (b) December 16,
2009, and deCODE has the call option to require NBI to sell the ARS to it at
any time until January 1, 2010. The repurchase price on exercise of the
put or call option (the Repurchase Price) will be equal to the Purchase Price
plus interest from January 16, 2009 at a rate of five percent (5%) above
the Reykjavik Interbank Offered Rate (REIBOR) in effect on the date payment is
made less the aggregate amount of interest and principal received by NBI on the
ARS. Due to the put and call options, the sale of the ARS to NBI was accounted
for as a secured borrowing and as such, the ARS remain on deCODEs Consolidated
Balance Sheet, although they are held by NBI, and continue to be marked to fair
value unless the put option as described above is not exercised prior to December 16,
2009. At June 30, 2009, deCODEs Obligation Under the Auction Rate Securities
Repurchase Agreement was $11.7 million on the Consolidated Balance Sheet, which
represents deCODEs liability at June 30, 2009 if the put or call right
had been exercised to repurchase the ARS. deCODE recognized interest expense
related to the put rights of $1.0 million during the six-months ended June 30,
2009.
Under the terms of certain technology licensing agreements, deCODE is
obligated to make payments upon the achievement of established milestones
leading to the discovery of defined products. These payments could total $5.0
million, with the timing of payments not determinable at the current time.
These potential payments are not included in the above table.
In November 2007, deCODE adopted a Change In Control Benefits Plan
that provides for, among other things, upon a change in control, all
outstanding stock options, restricted stock and stock appreciation rights, and
any similar awards under any equity compensation plan of deCODE, shall vest,
become immediately exercisable or payable and have all restrictions lifted. In
the event of a change in control, the Plan also requires deCODE to make a lump
sum payment to the CEO and reporting officers based on their most recent salary
and bonus history. Also, the Plan requires other benefits to be paid, to
include life, disability, accident and health insurance for these employees for
a period of 24 to 36 months depending on employment. deCODE believes that it is
unlikely that these circumstances will transpire, as such no charge has been
recognized in its Statements of Operations. Further, these potential payments
are not included in the above table. As of June 30, 2009, the potential
minimum lump sum payment (salary and bonus amounts only) under these change in
control provisions would have totaled approximately $6.1 million.
All material intercompany balances and transactions have been
eliminated. We do not have any other significant relationships with
unconsolidated entities or financial partnerships, such as entities often
referred to as structured finance or special purpose entities, which would have
been established for the purpose of facilitating off-balance sheet arrangements
or other contractually narrow or limited purposes. As such, we are not exposed
to any financing, liquidity, market or credit risk that could arise if we had
engaged in such relationships. Additionally, holders of our 3.5% senior
convertible notes may elect to convert their notes into shares of our common
stock at any time at a price of $14.00 per share.
Critical
Accounting Policies
The preparation of
financial statements in conformity with generally accepted accounting
principles requires us to make certain
24
Table of Contents
estimates and assumptions
that affect the reported amounts of assets and liabilities, the disclosure of
contingent assets and liabilities at the date of the financial statements, and
the reported amounts of revenues and expenses during the reported period. On an
ongoing basis we evaluate our estimates, which include, among others, those
related to collaborative arrangements, long-lived assets, and litigation and
other commitments and contingencies. We base our estimates on historical
experience and on various other assumptions that we believe to be reasonable
under the circumstances, the results of which form our basis for making
judgments about carrying values of assets and liabilities that are not readily
apparent from other sources. The impact and any associated risks related to
these and our other accounting policies on our business or operations is
discussed throughout Managements Discussion and Analysis of Financial
Condition and Results of Operations where such policies affect our reported and
expected financial results. For a detailed discussion on the application of
these and other accounting policies, please refer to our notes to the Condensed
Consolidated Financial Statements in this quarterly report on Form 10-Q
and the Consolidated Financial Statements in the Annual Report on Form 10-K.
There can be no assurance that actual results may not differ from the estimates
referred to above.
FORWARD-LOOKING STATEMENTS AND
CAUTIONARY FACTORS
THAT MAY AFFECT FUTURE RESULTS
This Quarterly Report on Form 10-Q
contains forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934. These statements relate to future events or our future
financial performance. In some cases, forward-looking statements can be
identified by terminology such as may, should, could, expect, plan, anticipate,
believe, estimate, predict, intend, potential or continue or the
negative of such terms or other comparable terminology. These statements are
only expectations. We cannot assure you that our expectations and assumptions
will prove to be correct. We do not intend to update or revise any
forward-looking statements, whether as a result of future events, new
information or otherwise, except to the extent that the reports we are required
to file under the Securities Exchange Act of 1934, as amended, (the Exchange
Act) contain such updates or revisions. Actual events or results may differ
materially from the forward- looking statements due to a number of factors,
including. but not limited to, those set forth in Item 1A of our Annual
Report on Form 10-K for the year ended December 31, 2008 as updated
by Item 1A of Part II of this Quarterly Report on Form 10-Q and
elsewhere in this Quarterly Report on Form 10-Q and in the reports we file
under the Exchange Act.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The primary objectives of
our investment activities are to preserve principal, maintain a high degree of
liquidity to meet operating needs, and obtain competitive returns subject to
prevailing market conditions. At June 30, 2009, our cash and cash
equivalents are in savings accounts and money market funds and our non-current
investments are in auction rate securities and which are pledged at June 30,
2009. At June 30, 2009, our cash and cash equivalents are largely invested
in U.S. dollar denominated checking accounts, money market and also in
Icelandic krona denominated accounts. Our obligation under the secured debt
collateralized by auction rate securities is denominated in Icelandic krona.
Our investments are subject to risk of default, changes in credit rating and
changes in market value. These investments are also subject to interest rate
risk and will decrease in value if market interest rates increase. A
hypothetical 100 basis point increase in interest rates would result in an
immaterial decrease in the fair value of our investments as of June 30,
2009. Changes in interest rates do not affect interest expense incurred on
deCODEs Convertible Notes, because they bear interest at a fixed rate. Using
the price in the latest trades in June 2009, the market value of the
Convertible Notes was approximately $15.3 million on June 30, 2009.
As a consequence of the
nature our business and operations our reported financial results and cash
flows are exposed to the risks associated with fluctuations in the exchange
rates of the U.S. dollar, the Icelandic krona and other world currencies. We
continue to monitor our exposure to currency risk. A hypothetical 10% decrease
in value of the U.S. dollar against the Icelandic krona would result in an
immaterial gain on our Icelandic krona denominated assets and liabilities.
ITEM
4. CONTROLS AND PROCEDURES
a)
Evaluation of disclosure controls and procedures.
Our Chief Executive Officer and our Chief Financial Officer evaluated the
effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under
the Securities Exchange Act of 1934, as amended (the Exchange Act)) as of the
end of the fiscal quarter covered by this Quarterly Report on Form 10-Q.
Based upon that evaluation, the Chief Executive Officer and the Chief Financial
Officer have concluded that as of the end of such fiscal quarter deCODEs
disclosure controls and procedures are adequate and effective to ensure that
information required to be disclosed in the reports deCODE files under the
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commissions rules and
forms. Disclosure controls and procedures include without limitation, controls
and procedures designed to ensure that information required to be disclosed by
an issuer in the reports that it files or submits under the Act is accumulated
and communicated to the issuers management including its principal executive
and principal financial officers or persons performing similar functions as
appropriate to allow timely decisions regarding required disclosures.
In designing and
evaluating our disclosure controls and procedures, our management recognizes
that any controls and procedures, no matter how well designed and operated, can
provide only reasonable assurance that the desired objectives of the control
system will be
25
Table of Contents
met. In addition, the
design of any control system is based in part upon certain assumptions about
the likelihood of future events and the application of judgment in evaluating
the cost-benefit relationship of possible controls and procedures. Because of
these and other inherent limitations of control systems, there is only
reasonable assurance that our controls will succeed in achieving their goals
under all potential future conditions.
b)
Changes in Internal Controls.
There was no
change in our internal control over financial reporting (as defined in Rule 13a-15(f) under
the Exchange Act) during the fiscal quarter covered by this Quarterly Report on
Form 10-Q that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
PART II
OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
Other than claims and legal proceedings that arise from time to time in
the ordinary course of business which are not material, and matters described
below, there has been no change in the matters reported in our Annual Report on
Form 10-K for the year ended December 31, 2008.
On or about April 20, 2002, an amended class action complaint,
captioned
In re deCODE genetics, Inc. Initial Public
Offering Securities Litigation
(01 Civ. 11219(SAS)), alleging
violations of federal securities laws in connection with deCODEs initial
public offering was filed in the United States District Court for the Southern
District of New York (the District Court) on behalf of certain purchasers of
deCODE common stock. The complaint names deCODE, two individuals who were
executive officers of deCODE at the time of its initial public offering (the Individual
Defendants), and the two lead underwriters (the Underwriter Defendants) for
our initial public offering in July 2000 (the IPO) as defendants. deCODE
is aware that similar allegations have been made in hundreds of other lawsuits
filed (many by some of the same plaintiff law firms) against numerous
underwriter defendants and issuer companies (and certain of their current and
former officers) in connection with various public offerings conducted in
recent years. All of the lawsuits that have been filed in the Southern District
of New York have been consolidated for pretrial purposes before United States
District Judge Shira Scheindlin. Pursuant to the underwriting agreement
executed in connection with our IPO, deCODE has demanded indemnification from
the Underwriter Defendants. The Underwriter Defendants have asserted that our
request for indemnification is premature.
Pursuant to an agreement the Individual Defendants have been dismissed
from the case without prejudice.
On July 31, 2003, our Board of Directors (other than our Chairman
and Chief Executive Officer, who recused himself because he was an Individual
Defendant) approved a proposed partial settlement with the plaintiffs in this
matter, subject to a number of conditions, including the participation of a
substantial number of other issuer defendants in the proposed settlement, the
consent of deCODEs insurers to the settlement, and the completion of acceptable
final settlement documentation. A settlement fairness hearing was held on April 24,
2006. On June 25, 2007, the United States District Court for the Southern
District of New York entered an order formally denying the motion for final
approval of the settlement agreement because the settlement class could not be
certified. On August 14, 2007, the plaintiffs filed their second
consolidated amended class action complaints against the focus cases and on September 27,
2007, again moved for class certification. The focus cases are a small group of
cases that were selected as test cases due to the large number of nearly
identical actions which were consolidated in the Initial Public Offering
litigation. The court has indicated that the focus cases are intended to
provide strong guidance for the other cases. The case involving deCODE is not a
focus case. On November 12, 2007, certain of the defendants in the focus
case moved to dismiss the second consolidated amended class action complaints.
On March 26, 2008, the District Court denied the motions to dismiss except
as to Section 11 claims raised by those plaintiffs who sold their
securities for a price in excess of the initial offering price and those who
purchased outside the previously certified class period. Briefing on the class
certification motion was completed in May 2008. That motion was withdrawn
without prejudice on October 10, 2008. On April 2, 2009, a
stipulation and agreement of settlement among the plaintiffs, issuer defendants
and underwriter defendants was submitted to the Court for preliminary approval.
The Court granted the plaintiffs motion for preliminary approval and
preliminarily certified the settlement classes on June 10, 2009. The
settlement fairness hearing has been scheduled for September 10, 2009.
Following the hearing, if the Court determines that the settlement is fair to
the class members, the settlement will be approved and the case against deCODE
and the Individual Defendants will be dismissed with prejudice. There can be no
assurance that this proposed settlement will be approved and implemented in its
current form, or at all. Due to the inherent uncertainties of litigation and
because the settlement approval process is at a preliminary stage, the ultimate
outcome of the matter is uncertain.
While
deCODEs expenses in this matter to date have been paid primarily by its
insurers, if deCODE were required to pay significant monetary damages as a
result of an adverse determination in this matter (or any other lawsuits
alleging similar claims filed against deCODE and deCODEs directors and
officers in the future), deCODEs business could be significantly harmed. Even
if such litigation concludes in deCODEs favor, deCODE may be required to
expend significant funds to defend against the allegations. deCODE is unable to
estimate the range of possible loss from this litigation and no amounts have
been provided for it in deCODEs financial statements.
26
Table
of Contents
ITEM
1A. RISK FACTORS
Other than with respect
to the risk factors set forth below, there have been no material changes from
the risk factors disclosed in Item 1A of our Annual Report on Form 10-K for
the year ended December 31, 2008. The risk factors set forth below have
been updated to provide data for and as of the quarter ended June 30,
2009.
We are
confronted by serious liquidity concerns which threaten our operations.
As of the date hereof, we
have very limited financial resources. Our operations to date have consumed
substantial amounts of cash and will continue to require substantial amounts of
cash in the future.
We are evaluating our alternatives for addressing
this situation, which include primarily the sale of business units and
programs, the sale or licensing of products and intellectual property, the
entry into corporate partnerships and the restructuring of our debt together
with new financing.
Given
our current liquid assets we have resources to continue operations only through
the latter half of the third quarter and must obtain further financial
resources in order to continue operations beyond this time. While negotiations
regarding various alternatives are ongoing, we cannot provide any assurance
that such negotiations will be completed within the time, or in a manner, that
will enable us to continue operations.
Our liquidity situation
has resulted in risks and uncertainties affecting our operations and the
execution of our business plan, including the following:
·
we may not be able to obtain and maintain normal terms
with vendors and service providers;
·
vendors and service providers may require security
deposits or prepayment before delivering goods and services, which will result
in additional demands on our cash;
·
we may incur costs associated with responding to the
concerns of customers, vendors and service providers, actual or threatened
litigation from vendors and service providers, and acceleration of contract
payments as a result of late payment;
·
we may not be able to maintain contracts, including
contracts with fee-paying customers, that are critical to our operations;
·
our ability to retain management and other key
individuals may be negatively affected; and
·
actions and decisions of our creditors and other third
parties with interests in our financial status may be inconsistent with our
plans.
We have identified and disclosed in Note 1 to our
consolidated financial statements a number of factors that raise substantial
doubt about our ability to continue as a going concern. If we become unable to
continue as a going concern, we would have to liquidate our assets, and we
might realize significantly less than the values at which they are carried on
our financial statements. The funds resulting from the liquidation of our
assets would be used first to pay off the debt owed to creditors before any
funds would be available to pay our stockholders, and any shortfall in the
proceeds would directly reduce the amounts available for distribution, if any,
to our creditors and to our stockholders. In the event we were required to
liquidate, it is unlikely that stockholders would receive any value for their
shares.
The report of our independent registered public
accounting firm on our financial statements included in our annual report on Form 10-K
contains an explanatory paragraph regarding going-concern uncertainty. The
accompanying financial statements do not include any adjustments or charges
that might be necessary should we be unable to continue as a going concern,
such as charges related to impairment of our assets, the recoverability and
classification of assets or the amounts and classification of liabilities or
other similar adjustments. If we are not able to continue as a going concern,
it is likely that investors will lose all or a part of their investment.
If we are able to continue operations in the near term, we
will continue to require sufficient additional funding to meet our capital
requirements; if we are not able to obtain such financing, we may be
forced to reduce or terminate our research and product development programs and
abandon portions of our intellectual property.
We have spent substantial
amounts of cash to fund our research and development activities and expect to
continue to spend substantial amounts for these activities over the next
several years. Many factors, including which, if any, assets we sell in order to
obtain funds to continue operations in the near future and which of our
business units and properties we retain, will influence our future capital
needs, including:
·
the number, breadth and progress of our discovery and
research programs;
·
our ability to attract customers;
·
our ability to commercialize our discoveries and the
resources we devote to commercialization;
27
Table of Contents
·
the amount we spend to obtain and enforce
patent claims and other intellectual property rights; and
·
the costs and timing of regulatory
approvals.
We have relied on, and may continue to rely on,
revenues generated by our corporate alliances and fee-paying customers for
significant funding of our research efforts. Historically, a substantial
portion of our revenue has been derived from contracts with a limited number of
significant customers as follows:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
United
States National Institutes of Health (NIH)
|
|
30
|
%
|
26
|
%
|
28
|
%
|
28
|
%
|
European
Community (EC)
|
|
26
|
%
|
14
|
%
|
26
|
%
|
14
|
%
|
The loss of any significant customer may significantly
lower deCODEs revenues which could affect the resources available to support
our product discovery and development programs.
In addition, we
may seek additional funding through public or private equity offerings and
debt financings. We may not be able to obtain additional financing when we
need it or the financing may not be on terms favorable to us or our
stockholders. Stockholders ownership will be diluted if we raise additional
capital by issuing equity securities. The going concern qualification from our
independent registered public accounting firm may make it more difficult for us
to raise funds.
If we raise
additional funds through collaborations and licensing arrangements, we
may have to relinquish rights to some of our technologies or product
candidates, or grant licenses on unfavorable terms. If adequate funds are not
available, we would have to scale back or terminate our discovery and research
programs and product development.
If we are able to continue operations in the near term but
continue to incur operating losses longer than anticipated, or in amounts
greater than anticipated, we may be unable to continue our operations.
We incurred a net
loss of $13.2 million and $25.8 million during the three and six-months ended June 30,
2009 and $18.4 million and $45.0 million during the three and six-months ended June 30,
2008, respectively, and $80.9 million during the year ended December 31,
2008, and had an accumulated deficit of $738.0 million at June 30, 2009.
We have never generated a profit and we have not generated significant revenues
except for payments received in connection with our research and development
collaborations with Roche, Merck and others, from contract services, and under
grants and more recently in April 2009 our licensing agreement with
Celera. Our research and development expenditures and general and
administrative costs have exceeded our revenue to date, and we expect to spend
significant additional amounts to develop our diagnostics and deCODEme
TM
products and
services, fund research and development in order to enhance our core
technologies and undertake product development (including drug development and
related clinical trials). We do not expect to receive royalties or other
revenues from commercial sales of products developed using our technology in
the near term. It may be several years before product revenues
materialize, if they do at all. As a result, we expect to incur net losses for
several years. If the time required to generate product revenues and achieve
profitability is longer than we currently anticipate or the level of losses is
greater than we currently anticipate, we may not be able to continue our
operations.
We may be adversely impacted by economic
factors beyond our control and may incur additional impairment charges to our
investment portfolio.
In January, 2009, we transferred $33.5 million principal amount of
auction rate securities (ARS) to an Icelandic financial institution
for an aggregate price of approximately $11.3 million. We have the call
option to require the financial institution to sell the securities back to
us at any time prior to December 31, 2009, and the financial
institution has the put option to require us to repurchase the securities upon
the earlier of (a) the sale of all or a majority of the stock of deCODE
genetics ehf, our Icelandic subsidiary,
(IE) or a specified part of the operations of IE or (b) December 16,
2009, in each case for a specified price. For accounting purposes this
transaction was accounted for as a secured borrowing and, as such, these ARS
investments remain on our balance sheet and are collateral pledged to and held
by the Icelandic institution. As of June 30, 2009, we had $33.5 million of
principal invested in auction rate securities (ARS), all of which are
classified as non-current investments on our balance sheet and are pledged to and held by
the purchaser. These investments represent interests in debt
obligations, namely life insurance wrapped issues, of companies offering credit
derivatives, and of entities on which monoline insurers retain capital put
rights. The remaining ARS investments are generally collateralized by pools of
commercial paper, investment-grade corporate debt, asset and mortgage-backed
securities, government and money-market issues and other ARS. Consistent with
our investment policy guidelines, all of the ARS investments were rated as
investment grade (at least A or better) at the time of purchase. The estimated
market value of the non-current ARS holdings at June 30, 2009 was $13.5
million, which reflects a $20.0 million adjustment to the principal value of
$33.5 million. Based on valuation models and an analysis of
other-than-temporary impairment factors, deCODE has recorded an impairment
charge of $0.1 million and $0.7 million for the three and six-months ended June 30,
2009, respectively, and $1.1 million and $5.1 million for the three and six-
28
Table of
Contents
months ended June 30,
2008, respectively, in Other non-operating income (expense), net in the
Statements of Operations, reflecting the portion of ARS holdings that deCODE
has concluded have an other-than-temporary decline in value. deCODE recognized
an unrealized gain of $1.0 million and $1.5 million in Other Comprehensive
Income during the three and six-months ended June 30, 2009, respectively.
During the six-months ended June 30, 2008, the $5.1 million charge
included $0.9 million related to ARS which deCODE had previously believed to be
temporary and accounted for as an unrealized loss at December 31, 2007.
The credit and capital markets continue to be
volatile. If uncertainties in credit and capital markets continue, these
markets deteriorate further or the estimated value of these ARS continue to
decline, we may incur additional impairments, realized or unrealized, to our
investment portfolio, which could negatively affect our financial condition,
cash flows and reported earnings. In addition, these uncertainties may make it
difficult, if not impossible, for us to obtain funding.
29
Table of Contents
ITEM
6. EXHIBITS
The following is a list
of exhibits filed as part of this Quarterly Report on Form 10-Q.
EXHIBIT
NUMBER
|
|
DESCRIPTION
OF EXHIBIT
|
|
|
|
3.1
|
|
Amended and Restated
Certificate of Incorporation, as further amended (Incorporated by reference
to Exhibit 3.1 and Exhibit 3.3 to the Companys Registration
Statement on Form S-1 (Registration No. 333-31984) which became
effective on July 17, 2000).
|
|
|
|
3.2
|
|
Certificate of
Amendment to Amended and Restated Certificate of Incorporation dated
August 30, 2002 (Incorporated by reference to Exhibit 3.2 to the
Companys Quarterly Report on Form 10-Q filed on November 14,
2002).
|
|
|
|
3.3
|
|
Certificate of
Amendment to Amended and Restated Certificate of Incorporation dated
May 11, 2007 (Incorporated by reference to Exhibit 3.3 to the
Companys Quarterly Report on Form 10-Q filed August 9, 2007).
|
|
|
|
3.4
|
|
Bylaws, as amended
(Incorporated by reference to Exhibit 3.2 to the Companys Registration
Statement on Form S-1 (Registration No. 333-31984) which became
effective on July 17, 2000).
|
|
|
|
10.1+
|
|
License Agreement
relating to cardiovascular and vascular diseases among deCODE
genetics, Inc., deCODE genetics, ehf, and Celera Corporation.
|
|
|
|
10.2+
|
|
License Agreement
relating to diabetes and metabolic syndrome among deCODE genetics, Inc.,
deCODE genetics, ehf, and Celera Corporation.
|
|
|
|
31.1
|
|
Certification pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
|
+
Confidential treatment has been requested
for certain portions of this exhibit. The omitted portions have been separately
filed with the Securities and Exchange Commission.
Note: Unless otherwise
noted, the SEC File number of each of the above referenced documents is
000-30469.
30
Table of Contents
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly
authorized.
Dated: August 10,
2009
|
deCODE genetics, Inc.
|
|
|
|
|
|
/s/ Kari Stefansson
|
|
|
Kari Stefansson
|
|
|
Chairman,
President,
|
|
|
and Chief
Executive Officer
|
|
|
|
|
|
|
|
|
/s/ Lance Thibault
|
|
|
Lance Thibault
|
|
|
Chief Financial
Officer and Treasurer
|
|
|
|
|
|
31
Table of Contents
EXHIBIT
NUMBER
|
|
DESCRIPTION
OF EXHIBIT
|
|
|
|
3.1
|
|
Amended and Restated
Certificate of Incorporation, as further amended (Incorporated by reference
to Exhibit 3.1 and Exhibit 3.3 to the Companys Registration
Statement on Form S-1 (Registration No. 333-31984) which became
effective on July 17, 2000).
|
|
|
|
3.2
|
|
Certificate of
Amendment to Amended and Restated Certificate of Incorporation dated
August 30, 2002 (Incorporated by reference to Exhibit 3.2 to the
Companys Quarterly Report on Form 10-Q filed on November 14,
2002).
|
|
|
|
3.3
|
|
Certificate of
Amendment to Amended and Restated Certificate of Incorporation dated
May 11, 2007 (Incorporated by reference to Exhibit 3.3 to the
Companys Quarterly Report on Form 10-Q filed August 9, 2007).
|
|
|
|
3.4
|
|
Bylaws, as amended
(Incorporated by reference to Exhibit 3.2 to the Companys Registration
Statement on Form S-1 (Registration No. 333-31984) which became
effective on July 17, 2000).
|
|
|
|
10.1+
|
|
License Agreement
relating to cardiovascular and vascular diseases among deCODE
genetics, Inc., deCODE genetics, ehf, and Celera Corporation.
|
|
|
|
10.2+
|
|
License Agreement
relating to diabetes and metabolic syndrome among deCODE genetics, Inc.,
deCODE genetics, ehf, and Celera Corporation.
|
|
|
|
31.1
|
|
Certification pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
|
+
Confidential treatment has been requested
for certain portions of this exhibit. The omitted portions have been separately
filed with the Securities and Exchange Commission.
Note: Unless otherwise
noted, the SEC File number of each of the above referenced documents is
000-30469.
32
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