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þ
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QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE
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q
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TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE
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Delaware
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76-0474169
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(State
or Other Jurisdiction of Incorporation
or Organization)
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(I.R.S.
Employer Identification
Number)
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Page
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2
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3
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Item
1.
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3
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Consolidated Balance Sheets – September 30, 2008
(unaudited) and December 31, 2007
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3
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||
Consolidated Statements of Operations (unaudited) –
Three and Nine Months Ended September 30, 2008 and
2007
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4
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||
Consolidated Statements of Cash Flows (unaudited) – Nine
Months Ended September 30, 2008 and 2007
|
5
|
||
Notes to Consolidated Financial Statements
(unaudited)
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6
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||
Item
2.
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13
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||
Item
3.
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22
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||
Item
4.
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22
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||
23
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|||
Item
1A.
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23
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Item
6.
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25
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26
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Item 1.
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Financial
Statements
|
As
of September 30,
|
As
of December 31,
|
|||||||
2008
|
2007
|
|||||||
Assets
|
(unaudited)
|
|||||||
Current
assets:
|
||||||||
Cash and cash equivalents
|
$ | 100,209 | $ | 22,938 | ||||
Short-term investments,
including restricted investments of $430
|
2,230 | 199,171 | ||||||
Short-term investments held by
Symphony Icon, Inc.
|
21,147 | 36,666 | ||||||
Accounts receivable, net of
allowance for doubtful accounts of $35
|
770 | 1,763 | ||||||
Prepaid expenses and other
current assets
|
7,069 | 4,112 | ||||||
Total current assets
|
131,425 | 264,650 | ||||||
Long-term
investments
|
53,678 | — | ||||||
Property
and equipment, net of accumulated depreciation and
amortization of $69,714 and $65,004, respectively
|
66,444 | 70,829 | ||||||
Goodwill
|
25,798 | 25,798 | ||||||
Other
assets
|
6,358 | 8,019 | ||||||
Total assets
|
$ | 283,703 | $ | 369,296 | ||||
|
||||||||
Liabilities, Noncontrolling Interest and
Stockholders’ Equity
|
||||||||
|
||||||||
Current
liabilities:
|
||||||||
Accounts payable
|
$ | 8,055 | $ | 7,344 | ||||
Accrued liabilities
|
9,338 | 9,093 | ||||||
Current portion of deferred
revenue
|
6,670 | 18,030 | ||||||
Current portion of long-term
debt
|
944 | 880 | ||||||
Total current liabilities
|
25,007 | 35,347 | ||||||
Deferred
revenue, net of current portion
|
14,212 | 16,126 | ||||||
Long-term
debt
|
29,779 | 30,493 | ||||||
Other
long-term liabilities
|
764 | 759 | ||||||
Total liabilities
|
69,762 | 82,725 | ||||||
Noncontrolling
interest in Symphony Icon, Inc.
|
14,260 | 30,271 | ||||||
|
||||||||
Commitments
and contingencies
|
||||||||
|
||||||||
Stockholders’
equity:
|
||||||||
Preferred stock, $.01 par
value; 5,000 shares authorized; no
shares issued and outstanding
|
— | — | ||||||
Common stock, $.001 par value;
300,000 shares authorized; 136,796
and 136,795 shares issued and outstanding, respectively
|
137 | 137 | ||||||
Additional paid-in capital
|
671,484 | 666,702 | ||||||
Accumulated deficit
|
(471,978 | ) | (410,535 | ) | ||||
Accumulated other comprehensive
gain (loss)
|
38 | (4 | ) | |||||
Total stockholders’ equity
|
199,681 | 256,300 | ||||||
Total liabilities and
stockholders’ equity
|
$ | 283,703 | $ | 369,296 |
Three
Months Ended September 30,
|
Nine
Months Ended
September
30,
|
|||||||||||||||
2008
|
2007
|
2008
|
2007
|
|||||||||||||
Revenues:
|
||||||||||||||||
Collaborative research
|
$ | 7,202 | $ | 9,712 | $ | 22,789 | $ | 34,460 | ||||||||
Subscription and license fees
|
310 | 455 | 3,182 | 1,850 | ||||||||||||
Total revenues
|
7,512 | 10,167 | 25,971 | 36,310 | ||||||||||||
Operating
expenses:
|
||||||||||||||||
Research and development,
including stock-based compensation
of $836, $965, $2,913 and $3,000,
respectively
|
27,642 | 24,518 | 85,793 | 77,402 | ||||||||||||
General and administrative,
including stock-based compensation
of $583, $635, $1,868 and $1,830, respectively
|
4,692 | 5,091 | 15,824 | 15,395 | ||||||||||||
Total operating expenses
|
32,334 | 29,609 | 101,617 | 92,797 | ||||||||||||
Loss
from operations
|
(24,822 | ) | (19,442 | ) | (75,646 | ) | (56,487 | ) | ||||||||
Impairment
of long-term investments
|
(3,322 | ) | — | (3,322 | ) | — | ||||||||||
Interest
income
|
956 | 2,166 | 5,155 | 3,811 | ||||||||||||
Interest
expense
|
(675 | ) | (694 | ) | (2,020 | ) | (2,077 | ) | ||||||||
Other
expense, net
|
(535 | ) | (8 | ) | (1,621 | ) | (34 | ) | ||||||||
Loss
before noncontrolling interest in Symphony Icon,
Inc.
|
(28,398 | ) | (17,978 | ) | (77,454 | ) | (54,787 | ) | ||||||||
Loss
attributable to noncontrolling interest in Symphony
Icon, Inc.
|
4,939 | 3,867 | 16,011 | 8,170 | ||||||||||||
Net
loss
|
$ | (23,459 | ) | $ | (14,111 | ) | $ | (61,443 | ) | $ | (46,617 | ) | ||||
Net
loss per common share, basic and diluted
|
$ | (0.17 | ) | $ | (0.14 | ) | $ | (0.45 | ) | $ | (0.53 | ) | ||||
Shares
used in computing net loss per common share, basic
and diluted
|
136,796 | 104,196 | 136,796 | 87,331 |
Nine
Months Ended September 30,
|
||||||||
2008
|
2007
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net loss
|
$ | (61,443 | ) | $ | (46,617 | ) | ||
Adjustments to reconcile net
loss to net cash used in operating activities:
|
||||||||
Depreciation
|
6,057 | 7,138 | ||||||
Amortization of Symphony Icon
purchase option
|
1,606 | — | ||||||
Loss attributable to
noncontrolling interest
|
(16,011 | ) | (8,170 | ) | ||||
Stock-based compensation
|
4,781 | 4,830 | ||||||
Impairment of long-term
investments
|
3,322 | — | ||||||
Changes in operating assets and
liabilities:
|
||||||||
(Increase) decrease in accounts
receivable
|
993 | (561 | ) | |||||
(Increase) decrease in prepaid
expenses and other current assets
|
(2,957 | ) | 627 | |||||
Decrease in other assets
|
55 | 82 | ||||||
Increase (decrease) in accounts
payable and other liabilities
|
961 | (317 | ) | |||||
Decrease in deferred revenue
|
(13,274 | ) | (17,021 | ) | ||||
Net cash used in operating
activities
|
(75,910 | ) | (60,009 | ) | ||||
Cash
flows from investing activities:
|
||||||||
Purchases of property and
equipment
|
(1,672 | ) | (1,297 | ) | ||||
Proceeds from disposal of property
and equipment
|
— | 1 | ||||||
Purchases of investments held by
Symphony Icon, Inc.
|
— | (44,991 | ) | |||||
Maturities of investments held by
Symphony Icon, Inc.
|
15,519 | 5,421 | ||||||
Purchases of investments
|
(39,847 | ) | (192,982 | ) | ||||
Maturities of investments
|
179,830 | 58,985 | ||||||
Net cash provided by (used in)
investing activities
|
153,830 | (174,863 | ) | |||||
Cash
flows from financing activities:
|
||||||||
Proceeds from issuance of common
stock to Invus, L. P., net of fees
|
— | 198,135 | ||||||
Proceeds from issuance of common
stock to Symphony Holdings, LLC,
net of fees
|
— | 14,238 | ||||||
Proceeds from exercise of stock
options
|
1 | 884 | ||||||
Repayment of debt borrowings
|
(650 | ) | (604 | ) | ||||
Proceeds from purchase of
noncontrolling interest by preferred
shareholders of Symphony Icon, Inc., net of fees
|
— | 42,714 | ||||||
Net cash provided by (used in)
financing activities
|
(649 | ) | 255,367 | |||||
Net
increase in cash and cash equivalents
|
77,271 | 20,495 | ||||||
Cash
and cash equivalents at beginning of period
|
22,938 | 30,226 | ||||||
Cash
and cash equivalents at end of period
|
$ | 100,209 | $ | 50,721 | ||||
Supplemental
disclosure of cash flow information:
|
||||||||
Cash paid for interest
|
$ | 1,962 | $ | 2,004 | ||||
Supplemental
disclosure of non-cash investing and financing activities:
|
||||||||
Common stock issued for purchase
option in conjunction with Symphony
Icon, Inc. financing
|
$ | — | $ | 8,564 | ||||
Unrealized gain (loss) on
investments
|
$ | 42 | $ | (146 | ) |
Expected
Volatility
|
Risk-free
Interest Rate
|
Expected
Term
|
Estimated
Forfeitures
|
Dividend
Rate
|
||||||||||||||||
September
30, 2008:
|
||||||||||||||||||||
Employees
|
66
|
%
|
2.9
|
%
|
6
|
22
|
%
|
0
|
%
|
|||||||||||
Officers
and non-employee directors
|
66
|
%
|
3.8
|
%
|
9
|
6
|
%
|
0
|
%
|
|||||||||||
September
30, 2007:
|
||||||||||||||||||||
Employees
|
67
|
%
|
4.5
|
%
|
6
|
21
|
%
|
0
|
%
|
|||||||||||
Officers
and non-employee directors
|
67
|
%
|
4.6
|
%
|
9
|
4
|
%
|
0
|
%
|
Options
|
Weighted
Average Exercise Price
|
||||||
(in
thousands)
|
|||||||
Outstanding
at December 31, 2007
|
16,351
|
$
|
5.65
|
||||
Granted
|
4,060
|
2.08
|
|||||
Exercised
|
(1
|
)
|
1.89
|
||||
Canceled
|
(3,091
|
)
|
3.84
|
||||
Outstanding
at September 30, 2008
|
17,319
|
5.14
|
|||||
Exercisable
at September 30, 2008
|
11,377
|
$
|
6.34
|
As
of September 30, 2008
|
||||||||||||||||
Amortized
Cost
|
Gross
Unrealized Gains
|
Gross
Unrealized Losses
|
Estimated
Fair Value
|
|||||||||||||
(In
thousands)
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
100,171
|
$
|
38
|
$
|
—
|
$
|
100,209
|
||||||||
Securities
maturing within one year:
|
||||||||||||||||
Certificates
of deposit
|
630
|
—
|
—
|
630
|
||||||||||||
Corporate
debt securities
|
1,600
|
—
|
—
|
1,600
|
||||||||||||
Total
short-term investments
|
$
|
2,230
|
$
|
—
|
$
|
—
|
$
|
2,230
|
||||||||
Short-term
investments held by Symphony Icon, Inc.:
|
||||||||||||||||
Cash
and cash equivalents
|
21,147
|
—
|
—
|
21,147
|
||||||||||||
Total
short-term investments held by Symphony Icon, Inc.
|
$
|
21,147
|
$
|
—
|
$
|
—
|
$
|
21,147
|
||||||||
Securities
maturing after ten years:
|
||||||||||||||||
Auction
rate securities
|
57,000
|
—
|
(3,322
|
)
|
53,678
|
|||||||||||
Total
long-term investments
|
$
|
57,000
|
$
|
—
|
$
|
(3,322
|
)
|
$
|
53,678
|
|||||||
Total
cash and cash equivalents and investments
|
$
|
180,548
|
$
|
38
|
$
|
(3,322
|
)
|
$
|
177,264
|
As
of December 31, 2007
|
||||||||||||||||
Amortized
Cost
|
Gross
Unrealized Gains
|
Gross
Unrealized Losses
|
Estimated
Fair Value
|
|||||||||||||
(In
thousands)
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
22,950
|
$
|
—
|
$
|
(12
|
)
|
$
|
22,938
|
|||||||
Securities
maturing within one year:
|
||||||||||||||||
Certificates
of deposit
|
6,312
|
—
|
(3
|
)
|
6,309
|
|||||||||||
Corporate
debt securities
|
41,162
|
12
|
(51
|
)
|
41,123
|
|||||||||||
Commercial
paper
|
71,214
|
47
|
—
|
71,261
|
||||||||||||
U.S.
government agencies securities
|
2,500
|
3
|
—
|
2,503
|
||||||||||||
Total
securities maturing within one year
|
121,188
|
62
|
(54
|
)
|
121,196
|
|||||||||||
Securities
maturing after ten years:
|
||||||||||||||||
Auction
rate securities
|
77,975
|
—
|
—
|
77,975
|
||||||||||||
Total
available-for-sale investments
|
$
|
199,163
|
$
|
62
|
$
|
(54
|
)
|
$
|
199,171
|
|||||||
Short-term
investments held by Symphony Icon, Inc.:
|
||||||||||||||||
Cash
and cash equivalents
|
36,666
|
—
|
—
|
36,666
|
||||||||||||
Total
short-term investments held by Symphony Icon, Inc.
|
$
|
36,666
|
$
|
—
|
$
|
—
|
$
|
36,666
|
||||||||
Total
cash and cash equivalents and investments
|
$
|
258,779
|
$
|
62
|
$
|
(66
|
)
|
$
|
258,775
|
|
·
|
Level
1 – quoted prices in active markets for identical
investments
|
|
·
|
Level
2 – other significant observable inputs (including quoted prices for
similar investments, market corroborated inputs,
etc.)
|
|
·
|
Level
3 – significant unobservable inputs (including the Company’s own
assumptions in determining the fair value of
investments)
|
Financial
Assets at Fair Value
as
of September 30, 2008
|
||||||||||||
Level
1
|
Level
2
|
Level
3
|
||||||||||
(in
thousands)
|
||||||||||||
Cash
and cash equivalents
|
$
|
100,209
|
$
|
—
|
$
|
—
|
||||||
Short-term
investments
|
2,230
|
—
|
—
|
|||||||||
Short-term
investments held by Symphony Icon, Inc.
|
21,147
|
—
|
—
|
|||||||||
Long-term
investments
|
—
|
—
|
53,678
|
|||||||||
Total
cash and cash equivalents and investments
|
$
|
123,586
|
$
|
—
|
$
|
53,678
|
Financial
Assets at Fair Value
as
of December 31, 2007
|
||||||||||||
Level
1
|
Level
2
|
Level
3
|
||||||||||
(in
thousands)
|
||||||||||||
Cash
and cash equivalents
|
$
|
22,938
|
$
|
—
|
$
|
—
|
||||||
Short-term
investments
|
199,171
|
—
|
—
|
|||||||||
Short-term
investments held by Symphony Icon, Inc.
|
36,666
|
—
|
—
|
|||||||||
Total
cash and cash equivalents and investments
|
$
|
258,775
|
$
|
—
|
$
|
—
|
Long-term
Investments
|
||||
(in
thousands)
|
||||
Balance
at December 31, 2007
|
$
|
—
|
||
Unrealized
losses included in earnings as impairment of long-term
investments
|
(3,322
|
)
|
||
Net
sales and settlements
|
(21,050
|
)
|
||
Transfers
into Level 3
|
78,050
|
|||
Balance
at September 30, 2008
|
$
|
53,678
|
Three
Months Ended September 30,
|
||||||||
2008
|
2007
|
|||||||
(in
thousands)
|
||||||||
Net
loss
|
$
|
(23,459
|
)
|
$
|
(14,111
|
)
|
||
Unrealized
gain (loss) on short-term investments
|
23
|
(153
|
)
|
|||||
Net
recognized loss on long-term investments included in
earnings
|
3,322
|
—
|
||||||
Net
unrealized change in value of long-term investments
|
82
|
—
|
||||||
Net
comprehensive loss
|
$
|
(20,196
|
)
|
$
|
(14,264
|
)
|
Nine
Months Ended September 30,
|
||||||||
2008
|
2007
|
|||||||
(in
thousands)
|
||||||||
Net
loss
|
$
|
(61,443
|
)
|
$
|
(46,617
|
)
|
||
Unrealized
gain (loss) on short-term investments
|
42
|
(146
|
)
|
|||||
Net
comprehensive loss
|
$
|
(61,401
|
)
|
$
|
(46,763
|
)
|
||
Item 2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
Three
Months Ended September 30,
|
Nine
Months Ended September 30,
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||||
Total
revenues
|
$
|
7.5
|
$
|
10.2
|
$
|
26.0
|
$
|
36.3
|
|||||||
Dollar
decrease
|
$
|
(2.7
|
)
|
$
|
(10.3
|
)
|
|||||||||
Percentage
decrease
|
(26
|
)%
|
(28
|
)%
|
|
·
|
Collaborative research
– Revenue from collaborative research for the three months ended
September 30, 2008 decreased 26% to $7.2 million, and for the
nine months ended September 30, 2008 decreased 34% to
$22.8 million, as compared to the comparable period for the prior
year, primarily due to the completion in 2007 of the project funded by our
award from the Texas Enterprise Fund, the completion in 2007 of the target
discovery portion of our alliance with Takeda Pharmaceutical Company
Limited, and reduced revenues in the three and nine months ended
September 30, 2008 under our alliance with N.V. Organon due to our
progress towards completing the target discovery portion of the
alliance.
|
|
·
|
Subscription and license
fees – Revenue from subscriptions and license fees for the three
months ended September 30, 2008 decreased 32% to $0.3 million,
as compared to the comparable period for the prior year. Revenue from
subscriptions and license fees for the nine months ended
September 30, 2008 increased 72% to $3.2 million, as compared to
the comparable period for the prior year, primarily due to an increase in
technology license fees.
|
Three
Months Ended September 30,
|
Nine
Months Ended September 30,
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||||
Total
research and development expense
|
$
|
27.6
|
$
|
24.5
|
$
|
85.8
|
$
|
77.4
|
|||||||
Dollar
increase
|
$
|
3.1
|
$
|
8.4
|
|||||||||||
Percentage
increase
|
13
|
%
|
11
|
%
|
|
·
|
Personnel – Personnel
costs for the three months ended September 30, 2008 decreased 16% to
$8.8 million, and for the nine months ended September 30, 2008
decreased 3% to $33.1 million, as compared to the comparable period
for the prior year, primarily due to lower salary and benefit
costs. Salaries, bonuses, employee benefits, payroll taxes,
recruiting and relocation costs are included in personnel
costs.
|
|
·
|
Facilities and equipment –
Facilities and equipment costs for the three months ended
September 30, 2008 decreased 1% to $4.7 million, and
for the nine months ended September 30, 2008 decreased 8% to
$14.1 million, as compared to the comparable period for the prior
year, primarily due to a decrease in depreciation
expense.
|
|
·
|
Laboratory supplies –
Laboratory supplies expense for the three months ended
September 30, 2008 decreased 29% to $2.0 million, and for the
nine months ended September 30, 2008 decreased 24% to
$6.7 million, as compared to the comparable period for the prior
year, primarily due to reallocating resources from genetic research to
drug development and as a result of the reduction in our personnel in May
2008.
|
|
·
|
Third-party and other services
– Third-party and other services for the three months ended
September 30, 2008 increased 132% to $10.1 million, and for the
nine months ended September 30, 2008 increased 98% to
$25.3 million, as compared to the comparable period for the prior
year, primarily due to an increase in external preclinical and clinical
research and development costs.
|
|
·
|
Stock-based compensation
– Stock-based compensation expense for the three months ended
September 30, 2008 decreased 13% to $0.8 million, and for the
nine months ended September 30, 2008 decreased 3% to
$2.9 million, as compared to the comparable period for the prior
year.
|
|
·
|
Other – Other costs for
the three months ended September 30, 2008 were $1.2 million,
consistent with the comparable period for the prior year. Other costs for
the nine months ended September 30, 2008 increased 6% to
$3.7 million, as compared to the comparable period for the prior
year.
|
Three
Months Ended September 30,
|
Nine
Months Ended September 30,
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||||
Total
general and administrative expense
|
$
|
4.7
|
$
|
5.1
|
$
|
15.8
|
$
|
15.4
|
|||||||
Dollar
increase (decrease)
|
$
|
(0.4
|
)
|
$
|
0.4
|
||||||||||
Percentage
increase (decrease)
|
(8
|
)%
|
3
|
%
|
|
·
|
Personnel – Personnel
costs for the three months ended September 30, 2008 decreased 7% to
$2.3 million, as compared to the comparable period for the prior
year, primarily due to lower salary and benefit costs associated with a
reduction in our personnel in May 2008. Personnel costs for the
nine months ended September 30, 2008 increased 4% to
$8.4 million, as compared to the comparable period for the prior
year, primarily due to higher severance costs associated with reductions
in our personnel. Salaries, bonuses, employee benefits, payroll
taxes, recruiting and relocation costs are included in personnel
costs.
|
|
·
|
Facilities and
equipment – Facilities and equipment costs for the three months
ended September 30, 2008 increased 11% to $0.7 million, as
compared to the comparable period for the prior
year. Facilities and equipment costs for the nine months ended
September 30, 2008 were $1.9 million, consistent with the
comparable period for the prior
year.
|
|
·
|
Professional fees –
Professional fees for the three months ended September 30, 2008
decreased 10% to $0.7 million, as compared to the comparable period
for the prior year. Professional fees for the nine months ended
September 30, 2008 increased 24% to $2.2 million, as compared to
the comparable period for the prior year, primarily due to increased
market research and other consulting
costs.
|
|
·
|
Stock-based
compensation – Stock-based compensation expense for the three
months ended September 30, 2008 was $0.6 million, consistent
with the comparable period for the prior year. Stock-based
compensation expense for the nine months ended September 30, 2008
increased 2% to $1.9 million as compared to the comparable period for
the prior year.
|
|
·
|
Other – Other costs for
the three months ended September 30, 2008 decreased 26% to
$0.4 million, and for the nine months ended September 30, 2008
decreased 16% to $1.5 million, as compared to the comparable period
for the prior year.
|
Item 3.
|
Quantitative
and Qualitative Disclosures about Market
Risk
|
Item 4.
|
Controls
and Procedures
|
Part II
|
Other
Information
|
|
·
|
we
will need additional capital in the future; if it is unavailable, we will
be forced to significantly curtail or cease operations and, if it is not
available on reasonable terms, we will be forced to obtain funds by
entering into financing agreements on unattractive
terms
|
|
·
|
we
have a history of net losses, and we expect to continue to incur net
losses and may not achieve or maintain
profitability
|
|
·
|
we
have licensed the intellectual property, including commercialization
rights, to our drug candidates LX6171, LX1031 and LX1032 to Symphony Icon
and will not receive any future royalties or revenues with respect to
these drug candidates unless we exercise our option to purchase Symphony
Icon
|
|
·
|
at
September 30, 2008, we held $57.0 million (par value), with an
estimated fair value of $53.7 million, of auction rate securities for
which auctions have failed and, as a result, we may not be able to access
these funds without a loss of
principal
|
|
·
|
our
operating results have been and likely will continue to fluctuate, and we
believe that period-to-period comparisons of our operating results are not
a good indication of our future
performance
|
|
·
|
we
are an early-stage company, and have not proven our ability to
successfully develop and commercialize drug candidates based on our drug
target discoveries
|
|
·
|
clinical
testing of our drug candidates in humans is an inherently risky and
time-consuming process that may fail to demonstrate safety and efficacy,
which could result in the delay, limitation or prevention of regulatory
approval
|
|
·
|
disagreements
with Symphony Icon regarding the development of our drug candidates
LX6171, LX1031 or LX1032 could negatively affect or delay their
development
|
|
·
|
we
are dependent in many ways upon our collaborations with major
pharmaceutical companies, and if we are unable to achieve milestones under
those collaborations or if our collaborators’ efforts fail to yield
pharmaceutical products on a timely basis, our opportunities to generate
revenues and earn royalties will be
reduced
|
|
·
|
conflicts
with our collaborators could jeopardize the success of our collaborative
agreements and harm our product development
efforts
|
|
·
|
we
lack the capability to manufacture materials for preclinical studies,
clinical trials or commercial sales and rely on third parties to
manufacture our drug candidates, which may harm or delay our product
development and commercialization
efforts
|
|
·
|
we
rely on third parties to carry out drug development
activities
|
|
·
|
our
drug candidates are subject to a lengthy and uncertain regulatory process
that may not result in the necessary regulatory approvals, which could
adversely affect our ability to commercialize
products
|
|
·
|
if
our potential products receive regulatory approval, we or our
collaborators will remain subject to extensive and rigorous ongoing
regulation
|
|
·
|
the
commercial success of any products that we may develop will depend upon
the degree of market acceptance of our products among physicians,
patients, health care payors, private health insurers and the medical
community
|
|
·
|
if
we are unable to establish sales and marketing capabilities or enter into
agreements with third parties to market and sell our drug candidates, we
may be unable to generate product
revenues
|
|
·
|
if
we are unable to obtain adequate coverage and reimbursement from
third-party payors for any products that we may develop, our revenues and
prospects for profitability will
suffer
|
|
·
|
our
competitors may develop products and technologies that make our products
and technologies obsolete
|
|
·
|
we
may not be able to manufacture our drug candidates in commercial
quantities, which would prevent us from commercializing our drug
candidates
|
|
·
|
if
we are unable to adequately protect our intellectual property, third
parties may be able to use our technology, which could adversely affect
our ability to compete in the
market
|
|
·
|
we
may be involved in patent litigation and other disputes regarding
intellectual property rights and may require licenses from third parties
for our discovery and development and planned commercialization
activities, and we may not prevail in any such litigation or other dispute
or be able to obtain required
licenses
|
|
·
|
we
use intellectual property that we license from third parties, and if we do
not comply with these licenses, we could lose our rights under
them
|
|
·
|
we
have not sought patent protection outside of the United States for some of
our inventions, and some of our licensed patents only provide coverage in
the United States, and as a result, our international competitors could be
granted foreign patent protection with respect to our
discoveries
|
|
·
|
we
may be subject to damages resulting from claims that we, our employees or
independent contractors have wrongfully used or disclosed alleged trade
secrets of their former employers
|
|
·
|
the
loss of key personnel or the inability to attract and retain additional
personnel could impair our ability to expand our
operations
|
|
·
|
our
collaborations with outside scientists may be subject to restriction and
change
|
|
·
|
difficulties
we may encounter managing our growth may divert resources and limit our
ability to successfully expand our
operations
|
|
·
|
security
breaches may disrupt our operations and harm our operating
results
|
|
·
|
any
contamination among our knockout mouse population could negatively affect
the reliability of our scientific research or cause us to incur
significant remedial costs
|
|
·
|
because
all of our target validation operations are located at a single facility,
the occurrence of a disaster could significantly disrupt our
business
|
|
·
|
we
use hazardous chemicals and radioactive and biological materials in our
business, and any claims relating to improper handling, storage or
disposal of these materials could be time consuming and
costly
|
|
·
|
we
may be sued for product liability
|
|
·
|
our
stock price may be extremely
volatile
|
|
·
|
we
may engage in future acquisitions, which may be expensive and time
consuming and from which we may not realize anticipated
benefits
|
|
·
|
future
sales of our common stock may depress our stock
price
|
|
·
|
Invus’
ownership of our common stock and its other rights under the stockholders’
agreement we entered into in connection with Invus’ $205.4 million initial
investment in our common stock provide Invus with substantial influence
over matters requiring stockholder approval, including the election of
directors and approval of significant corporate transactions, as well as
other corporate matters
|
Exhibit No.
|
Description
|
|
31.1
|
—
|
Certification
of Principal Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
31.2
|
—
|
Certification
of Principal Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
32.1
|
—
|
Certification
of Principal Executive and Principal Financial Officers Pursuant to
Section 906 of the Sarbanes-Oxley Act of
2002
|
Lexicon
Pharmaceuticals, Inc.
|
||
Date: October
31, 2008
|
By:
|
/s/
Arthur T. Sands
|
Arthur
T. Sands, M.D., Ph.D.
|
||
President
and Chief Executive Officer
|
Date: October
31, 2008
|
By:
|
/s/
James F. Tessmer
|
James
F. Tessmer
|
||
Vice
President, Finance and Accounting
|
Exhibit No.
|
Description
|
|
31.1
|
—
|
Certification of Principal Executive
Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
31.2
|
—
|
Certification of Principal Financial
Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
|
32.1
|
—
|
Certification of Principal Executive and
Principal Financial Officers Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|