UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
__________________
FORM
8-K
__________________
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event
reported): February
25, 2009
Lexicon
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-30111
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76-0474169
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(State
or other jurisdiction of
incorporation
or organization)
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(Commission
File Number)
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(I.R.S.
Employer
Identification
Number)
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8800
Technology Forest Place
The
Woodlands, Texas 77381
(Address
of principal executive
offices
and Zip Code)
(281)
863-3000
(Registrant’s
telephone number,
including
area code)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligations of the registrant under any of the following
provisions:
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□
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Written
communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
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□
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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□
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
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□
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c))
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Item
2.02
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Results
of Operations and Financial
Condition
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On
February 25, 2009, we issued a press release to report our financial results for
the quarter and year ended December 31, 2008. A copy of the press
release is attached to this current report on Form 8-K as
Exhibit 99.1.
The
information in this Form 8-K and the Exhibit attached to this Form 8-K shall not
be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934 (the “Exchange Act”) or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933 or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
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Item
9.01
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Financial Statements and
Exhibits
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(d) Exhibits
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Exhibit No.
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Description
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99.1
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—
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Press
Release of Lexicon Pharmaceuticals, Inc. dated February 25,
2009
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2
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.
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Lexicon
Pharmaceuticals, Inc.
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||
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Date: February
25, 2009
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By:
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/s/
Jeffrey L. Wade
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Jeffrey
L. Wade
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Executive Vice President
and
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General
Counsel
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3
Index
to Exhibits
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Exhibit No.
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Description
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99.1
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—
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Press
Release of Lexicon Pharmaceuticals, Inc. dated February 25,
2009
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Exhibit
99.1
LEXICON
PHARMACEUTICALS REPORTS 2008 FOURTH QUARTER
AND FULL YEAR FINANCIAL
RESULTS
Conference
Call and Webcast at 11:00 a.m. Eastern Time
The Woodlands, Texas, February 25,
2009 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical
company focused on discovering and developing breakthrough treatments for human
disease, today updated its drug development progress and reported financial
results for the three months and year ended December 31, 2008.
“In 2008,
the company made significant progress in moving multiple drug development
programs forward,” said Dr. Arthur T. Sands, president and chief executive
officer of Lexicon. “As part of our focus on the development of our
pipeline, we streamlined operations and concentrated our resources on our most
promising programs. We look forward to reporting data from several of
our programs as they progress through clinical trials this year for irritable
bowel syndrome, carcinoid syndrome, rheumatoid arthritis, and
diabetes.”
Key
Developments of 2008
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§
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Lexicon
initiated a Phase 2a clinical trial of its LX1031 drug candidate for
non-constipating irritable bowel syndrome (IBS) in December
2008. The trial is designed as a double-blind, randomized,
placebo-controlled study to evaluate the safety and tolerability of LX1031
and its effects on symptoms associated with IBS. In trials
completed to date, all dose levels and dosing regimes were well tolerated
with infrequent adverse events
observed.
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§
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Lexicon
completed dosing in a Phase 2a clinical trial of its LX6171 drug
candidate for cognitive disorders. Although the compound was
well tolerated, there was no clear demonstration of activity for the
various cognitive domains evaluated. The target of LX6171
continues to be of interest, as this pathway has recently been associated
with schizophrenia in human genetic studies. While the company
does not intend to pursue further development at this time, it plans to
evaluate interest from third parties in the compound and its target for
other neurobehavioral indications.
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§
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Lexicon
completed dosing in a Phase 1b clinical trial of its LX1032 drug
candidate for carcinoid syndrome. LX1032 was well tolerated at
all doses and demonstrated a potent reduction in both blood serotonin
levels and urinary 5-HIAA, a marker of serotonin
biosynthesis. Based on the results from this study, Lexicon is
planning to initiate a Phase 2 study in patients with carcinoid
syndrome in the first quarter of 2009. In June 2008, Lexicon
received Fast Track designation from the U.S. Food and Drug Administration
(FDA) for development of LX1032.
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§
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Lexicon
completed a Phase 1b clinical trial of its LX2931 drug candidate for
autoimmune disorders. In the trial, LX2931 was well tolerated
at all doses tested. A dose-dependent reduction in circulating
lymphocytes was observed, confirming the mechanism of action of LX2931 in
regulating lymphocyte trafficking. Lexicon initiated a
drug-drug interaction study with methotrexate in patients with rheumatoid
arthritis in the first quarter of
2009.
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§
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Lexicon
filed an investigational new drug (IND) application with the FDA for
LX4211, an oral small molecule drug candidate for diabetes. The
company initiated a Phase 1 clinical trial of LX4211 in January
2009. The trial is planned as a double-blind, randomized,
placebo-controlled, ascending single- and multiple-dose study to evaluate
the safety, tolerability, and pharmacokinetics of LX4211 in healthy
volunteers.
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§
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Lexicon
initiated formal preclinical development of LX7101, a new drug candidate
for glaucoma, in preparation for the planned filing of an IND application
with the FDA. LX7101 is a small molecule compound that may have
application in treating glaucoma by lowering intraocular pressure through
a new mechanism of action that enhances the eye’s fluid outflow
facility. Impairment of fluid outflow is thought to be a major
contributing factor to the higher incidence of glaucoma that is observed
as people age.
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§
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Lexicon
implemented reorganizations that reduced personnel and related
expenditures in 2008 and early 2009. These reorganizations were
designed to focus Lexicon's resources on its most advanced drug discovery
and development programs. As a result of the May 2008
reorganization, Lexicon reduced its expenses by approximately
$10 million on an annualized basis. As part of the January
2009 reorganization, Lexicon expects to reduce its expenses by an
additional approximately $8 million, net of severance costs, for the
balance of 2009 and approximately $11 million on an annualized
basis.
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Financial
Results
Revenues: Lexicon’s
revenues for the three months ended December 31, 2008 decreased
54 percent to $6.4 million from $13.8 million for the
corresponding period in 2007. The decrease for the three months ended
December 31, 2008 was primarily attributable to the completion in 2007 of
the project funded by Lexicon’s award from the Texas Enterprise Fund, reduced
revenues under Lexicon’s alliance with N.V. Organon, and reduced revenues under
Lexicon’s neuroscience alliance with Bristol-Myers Squibb resulting from
extending the estimated performance period under the agreement to June 30,
2009. For the year ended December 31, 2008, revenues decreased
36 percent to $32.3 million from $50.1 million in
2007.
Research and Development
Expenses: Research and development expenses for the three
months ended December 31, 2008 decreased 15 percent to
$22.8 million from $26.9 million for the corresponding period in
2007. The decrease was primarily attributable to decreased research
expenses as a result of the company reallocating resources from genetics
research efforts to drug development. For the year ended
December 31, 2008, research and development expenses increased four percent
to $108.6 million from $104.3 million in 2007.
General and Administrative
Expenses: General and administrative expenses for the three
months ended December 31, 2008 decreased 17 percent to
$4.5 million from $5.3 million for the corresponding period in
2007. The decrease was primarily attributable to lower salary and
benefit costs as well as lower stock-based compensation expense. For
the year ended December 31, 2008, general and administrative expenses
decreased two percent to $20.3 million from $20.7 million in
2007.
Net Loss: Net loss
for the three months ended December 31, 2008 was $15.4 million, or
$0.11 per share, compared to a net loss of $12.2 million, or
$0.09 per share, in the corresponding period in 2007. Net loss
for the year ended December 31, 2008 was $76.9 million, or
$0.56 per share, compared to a net loss of $58.8 million, or
$0.59 per share, in 2007. For the three months ended
December 31, 2008, net loss included non-cash, stock-based compensation
expense of $1.7 million, compared to $3.1 million in the corresponding
period in 2007. For the year ended December 31, 2008, net loss
included non-cash, stock-based compensation expense of $6.5 million,
compared to $7.9 million in 2007.
Cash and
Investments: As of December 31, 2008, Lexicon had
$158.8 million in cash and investments, including $16.6 million in
cash and investments held by Symphony Icon, as compared to $177.3 million
as of September 30, 2008 and $258.8 million as of December 31,
2007.
Lexicon
Conference Call:
Lexicon
management will hold a conference call to discuss its clinical development
progress, financial results for 2008 and financial guidance for 2009 at
11:00 a.m. Eastern Time on February 25, 2009. The dial-in
number for the conference call is 888-220-1244 (within the US/Canada) or
706-679-5615 (international). The conference ID for all callers is
83223654. Investors can access www.lexpharma.com to
listen to a live webcast of the call. The webcast will be archived
and available for review through March 4, 2009.
About
Lexicon
Lexicon
is a biopharmaceutical company focused on discovering and developing
breakthrough treatments for human disease. Lexicon currently has five
drug candidates in development for autoimmune disease, carcinoid syndrome,
diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by
the company’s research team. The company has used its proprietary
gene knockout technology to identify more than 100 promising drug
targets. Lexicon has focused drug discovery efforts on these
biologically-validated targets to create its extensive pipeline of clinical and
preclinical programs. For additional information about Lexicon and
its programs, please visit www.lexpharma.com.
Safe
Harbor Statement
This
press release contains “forward-looking statements,” including statements
relating to Lexicon’s clinical development of LX1031, LX1032, LX2931, LX4211,
LX6171 and LX7101 and the potential therapeutic and commercial potential of
LX1031, LX1032, LX2931, LX4211, LX6171 and LX7101. This press release
also contains forward-looking statements relating to Lexicon’s growth and future
operating results, discovery and development of products, strategic alliances
and intellectual property, as well as other matters that are not historical
facts or information. All forward-looking statements are based on
management’s current assumptions and expectations and involve risks,
uncertainties and other important factors, specifically including those relating
to Lexicon’s ability to successfully conduct clinical development of LX1031,
LX1032, LX2931, LX4211, LX6171 and LX7101 and preclinical and clinical
development of its other potential drug candidates, advance additional
candidates into preclinical and clinical development, obtain necessary
regulatory approvals, achieve its operational objectives, obtain patent
protection for its discoveries and establish strategic alliances, as well as
additional factors relating to manufacturing, intellectual property rights, and
the therapeutic or commercial value of its drug candidates, that may
cause Lexicon’s actual results to be materially different from any future
results expressed or implied by such forward-looking
statements. Information identifying such important factors is
contained under “Factors Affecting Forward-Looking Statements” and “Risk
Factors” in Lexicon’s annual report on Form 10-K for the year ended
December 31, 2007, as filed with the Securities and Exchange
Commission. Lexicon undertakes no obligation to update or revise any
such forward-looking statements, whether as a result of new information, future
events or otherwise.
# # #
Contact for
Lexicon:
Jason
Ray
Manager,
Corporate Communications and Community Affairs
281/863-3225
jray@lexpharma.com
Lexicon
Pharmaceuticals, Inc.
Selected
Financial Data
|
Consolidated
Statements of Operations Data
|
Three
Months Ended
December
31,
|
Year
Ended
December
31,
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||||||||||||||
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(In
thousands, except per share data)
|
2008
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2007
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2008
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2007
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||||||||||||
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(unaudited)
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(unaudited)
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|||||||||||||||
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Revenues:
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||||||||||||||||
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Collaborative
research
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$
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4,388
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$
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13,620
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$
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27,177
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$
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48,080
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||||||||
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Subscription and license
fees
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1,962
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188
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5,144
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2,038
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||||||||||||
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Total revenues
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6,350
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13,808
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32,321
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50,118
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||||||||||||
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Operating
expenses:
|
||||||||||||||||
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Research and development,
including stock-based compensation of $1,028, $2,150, $3,941 and $5,150,
respectively
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22,782
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26,930
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108,575
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104,332
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||||||||||||
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General and administrative,
including stock-based compensation of $691, $946, $2,559 and $2,776,
respectively
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4,457
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5,345
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20,281
|
20,740
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||||||||||||
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Total operating
expenses
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27,239
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32,275
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128,856
|
125,072
|
||||||||||||
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Loss
from operations
|
(20,889
|
)
|
(18,467
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)
|
(96,535
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)
|
(74,954
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)
|
||||||||
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Gain
(loss) on long-term investments, net
|
2,008
|
—
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(1,314
|
)
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—
|
|||||||||||
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Interest
income
|
607
|
3,475
|
5,762
|
7,286
|
||||||||||||
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Interest
expense
|
(671
|
)
|
(694
|
)
|
(2,691
|
)
|
(2,771
|
)
|
||||||||
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Other
expense, net
|
(485
|
)
|
(760
|
)
|
(2,106
|
)
|
(794
|
)
|
||||||||
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Loss
before noncontrolling interest in Symphony Icon, Inc.
|
(19,430
|
)
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(16,446
|
)
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(96,884
|
)
|
(71,233
|
)
|
||||||||
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Loss
attributable to noncontrolling interest in Symphony Icon,
Inc.
|
4,013
|
4,269
|
20,024
|
12,439
|
||||||||||||
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Net
loss
|
$
|
(15,417
|
)
|
$
|
(12,177
|
)
|
$
|
(76,860
|
)
|
$
|
(58,794
|
)
|
||||
|
Net
loss per common share, basic and diluted
|
$
|
(0.11
|
)
|
$
|
(0.09
|
)
|
$
|
(0.56
|
)
|
$
|
(0.59
|
)
|
||||
|
Shares
used in computing net loss per common share, basic and
diluted
|
136,797
|
136,794
|
136,797
|
99,798
|
||||||||||||
|
Consolidated
Balance Sheet Data
|
As
of December 31,
|
As
of December 31,
|
||||||
|
(In
thousands)
|
2008
|
2007
|
||||||
|
(unaudited)
|
||||||||
|
Cash
and investments, including cash and investments held by Symphony Icon,
Inc. $430
|
$
|
158,798
|
$
|
258,775
|
||||
|
Property
and equipment, net
|
65,087
|
70,829
|
||||||
|
Goodwill
|
25,798
|
25,798
|
||||||
|
Total
assets
|
261,508
|
369,296
|
||||||
|
Deferred
revenue
|
19,884
|
34,156
|
||||||
|
Current
and long-term debt
|
30,492
|
31,373
|
||||||
|
Noncontrolling
interest in Symphony Icon, Inc.
|
10,247
|
30,271
|
||||||
|
Accumulated
deficit
|
(487,395
|
)
|
(410,535
|
)
|
||||
|
Total
stockholders’ equity
|
185,580
|
256,300
|
||||||