þ
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE
|
q
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE
|
Delaware
|
76-0474169
|
(State
or Other Jurisdiction of
Incorporation
or Organization)
|
(I.R.S.
Employer
Identification
Number)
|
Yes
|
ü
|
No
|
Yes
|
ü
|
No
|
Yes
|
No
|
ü
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Page
|
||
2
|
||
Item
1.
|
||
Consolidated Balance Sheets – March 31, 2009
(unaudited) and December 31, 2008
|
3
|
|
Consolidated Statements of Operations
(unaudited) – Three Months Ended March 31, 2009 and
2008
|
4
|
|
Consolidated Statements of Stockholders’
Equity (unaudited) – Three Months Ended March 31, 2009 and
2008
|
5
|
|
Consolidated Statements of Cash Flows (unaudited) –
Three Months Ended March 31, 2009 and 2008
|
6
|
|
Notes to Consolidated Financial Statements
(unaudited)
|
7
|
|
Item
2.
|
17
|
|
Item
3.
|
25
|
|
Item
4.
|
25
|
|
Item
1A.
|
26
|
|
Item
6.
|
28
|
|
29
|
As
of March 31,
|
As
of December 31,
|
|||||||
2009
|
2008
|
|||||||
Assets
|
(unaudited)
|
|||||||
Current
assets:
|
||||||||
Cash and cash
equivalents
|
$
|
16,953
|
$
|
85,873
|
||||
Short-term investments,
including restricted investments of $430
|
60,479
|
629
|
||||||
Short-term investments held by
Symphony Icon, Inc.
|
11,832
|
16,610
|
||||||
Accounts receivable, net of
allowances of $35
|
1,248
|
568
|
||||||
Prepaid expenses and other
current assets
|
3,703
|
5,487
|
||||||
Total current
assets
|
94,215
|
109,167
|
||||||
Long-term
investments
|
56,203
|
55,686
|
||||||
Property
and equipment, net of accumulated depreciation and amortization of $72,887
and $71,102, respectively
|
63,027
|
65,087
|
||||||
Goodwill
|
25,798
|
25,798
|
||||||
Other
assets
|
5,209
|
5,770
|
||||||
Total assets
|
$
|
244,452
|
$
|
261,508
|
||||
Liabilities
and Equity
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$
|
3,083
|
$
|
7,926
|
||||
Accrued
liabilities
|
5,106
|
6,615
|
||||||
Current portion of deferred
revenue
|
3,109
|
5,672
|
||||||
Current portion of long-term
debt
|
984
|
963
|
||||||
Total current
liabilities
|
12,282
|
21,176
|
||||||
Deferred
revenue, net of current portion
|
14,212
|
14,212
|
||||||
Long-term
debt
|
43,939
|
29,529
|
||||||
Other
long-term liabilities
|
727
|
764
|
||||||
Total
liabilities
|
71,160
|
65,681
|
||||||
Commitments
and contingencies
|
||||||||
Equity:
|
||||||||
Lexicon Pharmaceuticals, Inc.
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; 137,331 and 136,797 shares issued and
outstanding, respectively
|
137
|
137
|
||||||
Additional paid-in
capital
|
674,645
|
672,838
|
||||||
Accumulated
deficit
|
(508,955
|
)
|
(487,395
|
)
|
||||
Accumulated other
comprehensive loss
|
(5
|
)
|
—
|
|||||
Total Lexicon Pharmaceuticals,
Inc. stockholders’ equity
|
165,822
|
185,580
|
||||||
Noncontrolling interest in
Symphony Icon, Inc.
|
7,470
|
10,247
|
||||||
Total equity
|
173,292
|
195,827
|
||||||
Total liabilities and
equity
|
$
|
244,452
|
$
|
261,508
|
Three
Months Ended March 31,
|
|||||||||
2009
|
2008
|
||||||||
Revenues:
|
|||||||||
Collaborative
research
|
$
|
3,605
|
$
|
7,634
|
|||||
Subscription and license
fees
|
563
|
1,259
|
|||||||
Total revenues
|
4,168
|
8,893
|
|||||||
Operating
expenses:
|
|||||||||
Research and development,
including stock-based compensation of $829 and $1,127,
respectively
|
22,976
|
27,802
|
|||||||
General and administrative,
including stock-based compensation of $613 and $652,
respectively
|
4,762
|
5,529
|
|||||||
Total
operating expenses
|
27,738
|
33,331
|
|||||||
Loss
from operations
|
(23,570
|
)
|
(24,438
|
)
|
|||||
Gain
on long-term investments, net
|
517
|
—
|
|||||||
Interest
income
|
327
|
2,781
|
|||||||
Interest
expense
|
(666
|
)
|
(670
|
)
|
|||||
Other
expense, net
|
(945
|
)
|
(547
|
)
|
|||||
Consolidated
net loss
|
(24,337
|
)
|
(22,874
|
)
|
|||||
Less:
Net loss attributable to noncontrolling interest in Symphony Icon,
Inc.
|
2,777
|
4,924
|
|||||||
Net
loss attributable to Lexicon Pharmaceuticals, Inc.
|
$
|
(21,560
|
)
|
$
|
(17,950
|
)
|
|||
Net
loss attributable to Lexicon Pharmaceuticals, Inc. per common share, basic
and diluted
|
$
|
(0.16
|
)
|
$
|
(0.13
|
)
|
|||
Shares
used in computing net loss attributable to Lexicon Pharmaceuticals, Inc.
per common share, basic and diluted
|
137,075
|
136,795
|
Lexicon
Pharmaceuticals, Inc. Stockholders
|
||||||||||||||||||||||||||||||||
Additional
Paid-In Capital
|
Accumulated
Deficit
|
Accumulated
Other Comprehensive Loss
|
Total
|
Noncontrolling
Interest
|
Total
Equity
|
|||||||||||||||||||||||||||
Common
Stock
|
||||||||||||||||||||||||||||||||
Shares
|
Par
Value
|
|||||||||||||||||||||||||||||||
Balance
at December 31, 2007
|
136,796
|
$
|
137
|
$
|
666,702
|
$
|
(410,535
|
)
|
$
|
(4
|
)
|
$
|
256,300
|
$
|
30,271
|
$
|
286,571
|
|||||||||||||||
Stock-based
compensation
|
—
|
—
|
1,779
|
—
|
—
|
1,779
|
—
|
1,779
|
||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
(17,950
|
)
|
—
|
(17,950
|
)
|
(4,924
|
)
|
(22,874
|
)
|
||||||||||||||||||||
Unrealized
loss on investments
|
—
|
—
|
—
|
—
|
(2,328
|
)
|
(2,328
|
)
|
—
|
(2,328
|
)
|
|||||||||||||||||||||
Comprehensive
loss
|
(20,278
|
)
|
(25,202
|
)
|
||||||||||||||||||||||||||||
Balance
at March 31, 2008
|
136,796
|
$
|
137
|
$
|
668,481
|
$
|
(428,485
|
)
|
$
|
(2,332
|
)
|
$
|
237,801
|
$
|
25,347
|
$
|
263,148
|
|||||||||||||||
Balance
at December 31, 2008
|
136,797
|
$
|
137
|
$
|
672,838
|
$
|
(487,395
|
)
|
$
|
—
|
$
|
185,580
|
$
|
10,247
|
$
|
195,827
|
||||||||||||||||
Stock-based
compensation
|
—
|
—
|
1,807
|
—
|
—
|
1,807
|
—
|
1,807
|
||||||||||||||||||||||||
Grant
of restricted stock
|
534
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
(21,560
|
)
|
—
|
(21,560
|
)
|
(2,777
|
)
|
(24,337
|
)
|
||||||||||||||||||||
Unrealized
loss on investments
|
—
|
—
|
—
|
—
|
(5
|
)
|
(5
|
)
|
—
|
(5
|
)
|
|||||||||||||||||||||
Comprehensive
loss
|
(21,565
|
)
|
(24,342
|
)
|
||||||||||||||||||||||||||||
Balance
at March 31, 2009
|
137,331
|
$
|
137
|
$
|
674,645
|
$
|
(508,955
|
)
|
$
|
(5
|
)
|
$
|
165,822
|
$
|
7,470
|
$
|
173,292
|
Three
Months Ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss attributable to Lexicon Pharmaceuticals, Inc.
|
$
|
(21,560
|
)
|
$
|
(17,950
|
)
|
||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
|
1,772
|
2,058
|
||||||
Impairment
of fixed assets
|
406
|
—
|
||||||
Amortization
of Symphony Icon, Inc. purchase option
|
535
|
535
|
||||||
Loss
attributable to noncontrolling interest
|
(2,777
|
)
|
(4,924
|
)
|
||||
Stock-based
compensation
|
1,442
|
1,779
|
||||||
Impairment
of long-term investments
|
41
|
—
|
||||||
Gain
on ARS Rights
|
(558
|
)
|
—
|
|||||
Loss
on disposal of property and equipment
|
2
|
—
|
||||||
Changes
in operating assets and liabilities:
|
||||||||
(Increase)
decrease in accounts receivable
|
(680
|
)
|
519
|
|||||
Decrease
in prepaid expenses and other current assets
|
1,784
|
489
|
||||||
Decrease
in other assets
|
26
|
22
|
||||||
Decrease
in accounts payable and other liabilities
|
(6,024
|
)
|
(2,787
|
)
|
||||
Decrease
in deferred revenue
|
(2,563
|
)
|
(6,296
|
)
|
||||
Net
cash used in operating activities
|
(28,154
|
)
|
(26,555
|
)
|
||||
Cash
flows from investing activities:
|
||||||||
Purchases
of property and equipment
|
(156
|
)
|
(879
|
)
|
||||
Proceeds
from disposal of property and equipment
|
36
|
—
|
||||||
Maturities
of investments held by Symphony Icon, Inc.
|
4,778
|
3,245
|
||||||
Purchases
of short-term investments
|
(59,955
|
)
|
(39,848
|
)
|
||||
Maturities
of short-term investments
|
100
|
100,773
|
||||||
Net
cash provided by (used in) investing activities
|
(55,197
|
)
|
63,291
|
|||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from debt borrowings
|
14,800
|
—
|
||||||
Repayment
of debt borrowings
|
(369
|
)
|
(217
|
)
|
||||
Net
cash provided by (used in) financing activities
|
14,431
|
(217
|
)
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
(68,920
|
)
|
36,519
|
|||||
Cash
and cash equivalents at beginning of period
|
85,873
|
22,938
|
||||||
Cash
and cash equivalents at end of period
|
$
|
16,953
|
$
|
59,457
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||
Cash
paid for interest
|
$
|
626
|
$
|
656
|
||||
Supplemental
disclosure of non-cash investing and financing activities:
|
||||||||
Unrealized
loss on investments
|
$
|
(5
|
)
|
$
|
(2,328
|
)
|
Expected
Volatility
|
Risk-free
Interest Rate
|
Expected
Term
|
Estimated
Forfeitures
|
Dividend
Rate
|
||||||||||||||||
March
31, 2009:
|
||||||||||||||||||||
Employees
|
78
|
%
|
1.9
|
%
|
5
|
23
|
%
|
0
|
%
|
|||||||||||
Officers
and non-employee directors
|
76
|
%
|
2.6
|
%
|
8
|
6
|
%
|
0
|
%
|
|||||||||||
March
31, 2008:
|
||||||||||||||||||||
Employees
|
66
|
%
|
2.9
|
%
|
6
|
20
|
%
|
0
|
%
|
|||||||||||
Officers
and non-employee directors
|
66
|
%
|
3.8
|
%
|
9
|
4
|
%
|
0
|
%
|
Options
|
Weighted
Average Exercise Price
|
|||||
(in
thousands)
|
||||||
Outstanding
at December 31, 2008
|
16,898
|
$
|
5.13
|
|||
Granted
|
4,448
|
1.45
|
||||
Expired
|
(539
|
)
|
4.37
|
|||
Forfeited
|
(392
|
)
|
2.73
|
|||
Outstanding
at March 31, 2009
|
20,415
|
4.39
|
||||
Exercisable
at March 31, 2009
|
12,068
|
$
|
6.01
|
Shares
|
Weighted
Average Grant Date
Fair
Value
|
||||||
(in
thousands)
|
|||||||
Outstanding
at December 31, 2008
|
—
|
$
|
—
|
||||
Granted
|
534
|
1.45
|
|||||
Nonvested
at March 31, 2009
|
534
|
$
|
1.45
|
As
of March 31, 2009
|
||||||||||||||||
Amortized
Cost
|
Gross
Unrealized Gains
|
Gross
Unrealized Losses
|
Estimated
Fair Value
|
|||||||||||||
(In
Thousands)
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
16,953
|
$
|
—
|
$
|
—
|
$
|
16,953
|
||||||||
Securities
maturing within one year:
|
||||||||||||||||
Certificates
of deposit
|
509
|
—
|
—
|
509
|
||||||||||||
U.S.
treasury securities
|
59,975
|
—
|
(5
|
)
|
59,970
|
|||||||||||
Total short-term
investments
|
$
|
60,484
|
$
|
—
|
$
|
(5
|
)
|
$
|
60,479
|
|||||||
Securities
maturing after one year through five years:
|
||||||||||||||||
ARS
Rights
|
—
|
12,618
|
—
|
12,618
|
||||||||||||
Securities
maturing after ten years:
|
||||||||||||||||
Auction
rate securities
|
57,000
|
—
|
(13,415
|
)
|
43,585
|
|||||||||||
Total long-term
investments
|
$
|
57,000
|
$
|
12,618
|
$
|
(13,415
|
)
|
$
|
56,203
|
|||||||
Short-term
investments held by Symphony Icon, Inc.:
|
||||||||||||||||
Cash
and cash equivalents
|
11,832
|
—
|
—
|
11,832
|
||||||||||||
Total short-term investments
held by Symphony Icon, Inc.
|
$
|
11,832
|
$
|
—
|
$
|
—
|
$
|
11,832
|
||||||||
Total
cash and cash equivalents and investments
|
$
|
146,269
|
$
|
12,618
|
$
|
(13,420
|
)
|
$
|
145,467
|
As
of December 31, 2008
|
||||||||||||||||
Amortized
Cost
|
Gross
Unrealized Gains
|
Gross
Unrealized Losses
|
Estimated
Fair Value
|
|||||||||||||
(In
thousands)
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
85,873
|
$
|
—
|
$
|
—
|
$
|
85,873
|
||||||||
Securities
maturing within one year:
|
||||||||||||||||
Certificates of
deposit
|
629
|
—
|
—
|
629
|
||||||||||||
Total short-term
investments
|
$
|
629
|
$
|
—
|
$
|
—
|
$
|
629
|
||||||||
Securities
maturing after one year through five years:
|
||||||||||||||||
ARS Rights
|
—
|
12,060
|
—
|
12,060
|
||||||||||||
Securities
maturing after ten years:
|
||||||||||||||||
Auction rate
securities
|
57,000
|
—
|
(13,374
|
)
|
43,626
|
|||||||||||
Total long-term
investments
|
$
|
57,000
|
$
|
12,060
|
$
|
(13,374
|
)
|
$
|
55,686
|
|||||||
Short-term
investments held by Symphony Icon, Inc.:
|
||||||||||||||||
Cash and cash
equivalents
|
16,610
|
—
|
—
|
16,610
|
||||||||||||
Total short-term investments
held by Symphony Icon, Inc.
|
$
|
16,610
|
$
|
—
|
$
|
—
|
$
|
16,610
|
||||||||
Total
cash and cash equivalents and investments
|
$
|
160,112
|
$
|
12,060
|
$
|
(13,374
|
)
|
$
|
158,798
|
|
·
|
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 March
31, 2009
|
||||||||||||||||
Level
1
|
Level
2
|
Level
3
|
Total
|
|||||||||||||
(in
thousands)
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
16,953
|
$
|
—
|
$
|
—
|
$
|
16,953
|
||||||||
Short-term
investments
|
60,479
|
—
|
—
|
60,479
|
||||||||||||
Short-term
investments held by Symphony Icon, Inc.
|
11,832
|
—
|
—
|
11,832
|
||||||||||||
Long-term
investments
|
—
|
—
|
56,203
|
56,203
|
||||||||||||
Total
cash and cash equivalents and investments
|
$
|
89,264
|
$
|
—
|
$
|
56,203
|
$
|
145,467
|
Financial Assets at Fair
Value as of
December 31, 2008
|
||||||||||||||||
Level
1
|
Level
2
|
Level
3
|
Total
|
|||||||||||||
(in
thousands)
|
||||||||||||||||
Cash
and cash equivalents
|
$
|
85,873
|
$
|
—
|
$
|
—
|
$
|
85,873
|
||||||||
Short-term
investments
|
629
|
—
|
—
|
629
|
||||||||||||
Short-term
investments held by Symphony Icon, Inc.
|
16,610
|
—
|
—
|
16,610
|
||||||||||||
Long-term
investments
|
—
|
—
|
55,686
|
55,686
|
||||||||||||
Total
cash and cash equivalents and investments
|
$
|
103,112
|
$
|
—
|
$
|
55,686
|
$
|
158,798
|
Long-term
Investments
|
||||
(in
thousands)
|
||||
Balance
at December 31, 2008
|
$
|
55,686
|
||
Unrealized
gains included in earnings as gain on long-term investments,
net
|
517
|
|||
Balance
at March 31, 2009
|
$
|
56,203
|
Three
Months Ended March 31,
|
||||||||
2009
|
2008
|
|||||||
(in
thousands)
|
||||||||
Net
loss attributable to Lexicon Pharmaceuticals, Inc.
|
$
|
(21,560
|
)
|
$
|
(17,950
|
)
|
||
Unrealized
gain (loss) on short-term investments
|
(5
|
)
|
209
|
|||||
Unrealized
loss on long-term investments
|
—
|
(2,537
|
)
|
|||||
Net
comprehensive loss attributable to Lexicon Pharmaceuticals,
Inc.
|
$
|
(21,565
|
)
|
$
|
(20,278
|
)
|
Three
Months Ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Total
revenues
|
$
|
4.2
|
$
|
8.9
|
||||
Dollar
decrease
|
$
|
(4.7
|
)
|
|||||
Percentage
decrease
|
(53
|
)%
|
|
·
|
Collaborative research
– Revenue from collaborative research decreased 53% to $3.6 million,
primarily due to reduced revenues in the three months ended March 31,
2009 under our alliance with Bristol-Myers Squibb, reduced revenues under
our alliance with N.V. Organon due to our progress towards completing the
target discovery portion of the alliance, and the completion in 2008 of
the target discovery portion of our alliance with
Genentech.
|
|
·
|
Subscription and license
fees – Revenue from subscriptions and license fees decreased 55% to
$0.6 million, primarily due to a decrease in technology license
fees.
|
Three
Months Ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Total
research and development expense
|
$
|
23.0
|
$
|
27.8
|
||||
Dollar
decrease
|
$
|
(4.8
|
)
|
|||||
Percentage
decrease
|
(17
|
)%
|
|
·
|
Personnel – Personnel
costs decreased 11% to $10.6 million, primarily due to reductions in
our personnel in May 2008 and January 2009, offset in part by associated
severance costs. Salaries, bonuses, employee benefits, payroll
taxes, recruiting and relocation costs are included in personnel
costs.
|
|
·
|
Facilities and equipment –
Facilities and equipment costs decreased 12% to $4.1 million,
primarily due to a decrease in depreciation
expense.
|
|
·
|
Laboratory supplies –
Laboratory supplies expense decreased 35% to $1.7 million,
primarily as a result of reductions in our personnel in May 2008 and
January 2009.
|
|
·
|
Third-party and other services
– Third-party and other services decreased 23% to
$4.9 million, primarily due to a decrease in external preclinical
research and development costs.
|
|
·
|
Stock-based compensation
– Stock-based compensation expense decreased 26% to
$0.8 million.
|
|
·
|
Other – Other costs
decreased 27% to $0.8 million.
|
Three
Months Ended March 31,
|
||||||||
2009
|
2008
|
|||||||
Total
general and administrative expense
|
$
|
4.8
|
$
|
5.5
|
||||
Dollar
decrease
|
$
|
(0.8
|
)
|
|||||
Percentage
decrease
|
(14
|
)%
|
|
·
|
Personnel – Personnel
costs decreased 12% to $2.5 million, primarily due to reductions in
our personnel in May 2008 and January 2009. Salaries, bonuses,
employee benefits, payroll taxes, recruiting and relocation costs are
included in personnel costs.
|
|
·
|
Facilities and
equipment – Facilities and equipment costs increased 11% to
$0.7 million.
|
|
·
|
Professional fees –
Professional fees decreased 25% to $0.6 million, primarily due to
decreased legal fees and market research
costs.
|
|
·
|
Stock-based
compensation – Stock-based compensation expense decreased 6% to
$0.6 million.
|
|
·
|
Other – Other costs
decreased 42% to $0.3 million.
|
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 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
March 31, 2009, we held $57.0 million (par value), with an
estimated fair value of $43.6 million, of auction rate securities for
which auctions have failed and, as a result, we may not be able to access
at least the portion of these funds for which alternative funding is not
available through our credit line with UBS Bank USA 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
|
|
·
|
multiple
or alternative approaches may provide advantages or benefits in the
development of certain drug candidates and disagreements with Symphony
Icon regarding the development of our drug candidates 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
|
|
·
|
security
breaches may disrupt our operations and harm our operating
results
|
|
·
|
because
most of our 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: April
29, 2009
|
By:
|
/s/
Arthur T. Sands
|
Arthur
T. Sands, M.D., Ph.D.
|
||
President
and Chief Executive Officer
|
Date: April
29, 2009
|
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
|