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): April 29,
2008
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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□ |
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
April 29, 2008, we issued a press release to report our financial results for
the quarter ended March 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 April 29,
2008
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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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Date: April
29, 2008
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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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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 April 29,
2008
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Exhibit
99.1
LEXICON
PHARMACEUTICALS REPORTS 2008
FIRST
QUARTER FINANCIAL RESULTS
Conference
Call and Webcast at 5:00 p.m. Eastern Time
The Woodlands, Texas, April 29,
2008 – 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 ended March 31,
2008.
“We
are continuing to advance our diverse target portfolio into clinical
development,” said Dr. Arthur T. Sands, president and chief executive officer of
Lexicon. “Our clinical programs are progressing, and recent positive
results reinforce the company’s drug discovery strategy.”
Highlights
Clinical
Achievements
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§
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Lexicon
obtained encouraging results from its initial Phase 1 clinical trial of
LX2931, the company’s oral drug candidate for autoimmune conditions,
including rheumatoid arthritis. Initial results from this
single ascending-dose trial in healthy volunteers demonstrated a potent,
dose-dependent reduction in circulating lymphocytes, suggesting that the
target of LX2931 represents a potential new mechanism of action for
regulating the immune response.
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§
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The
company reported Phase 1 results for LX6171, an internally-developed
compound under evaluation by the company as a potential treatment for
cognitive disorders, at the American Academy of Neurology in Chicago on
April 15, 2008. Initial human studies showed that the compound
achieved good systemic exposure and was well tolerated at the doses
studied. The target of LX6171, identified through Lexicon’s
Genome5000™ program,
was disclosed as SLC6A7, a high-affinity L-proline transporter found in
the brain. SLC6A7 represents a potential new mechanism of
action for the treatment of cognitive disorders. LX6171 is
currently in a Phase 2 study for age-associated memory impairment in
elderly subjects.
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§
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Lexicon
commenced initial Phase 1 dosing for LX1032, the company’s oral drug
candidate for managing gastrointestinal symptoms associated with carcinoid
syndrome. The initial Phase 1 clinical trial of LX1032 is a
double-blind, randomized, placebo-controlled, ascending single-dose study
in healthy volunteers.
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Financial
Results
Revenues: Lexicon’s
revenues for the three months ended March 31, 2008 decreased 34 percent to
$8.9 million from $13.5 million for the corresponding period in
2007. The decrease was primarily attributable to the completion in
2007 of the project funded by Lexicon’s award from the
Texas Enterprise Fund, reduced revenues in the three months ended March 31,
2008 under its alliance with N.V. Organon due to its progress towards completing
the target discovery portion of the alliance, and the completion in 2007 of the
target discovery portion of its alliance with Takeda Pharmaceutical Company
Limited.
Research and Development
Expenses: Research and development expenses for the three
months ended March 31, 2008 increased two percent to $27.8 million
from $27.3 million for the corresponding period in 2007. The
increase was primarily due to higher preclinical and clinical costs related to
the advancement of Lexicon’s drug development programs, partially offset by
decreased research expenses as a result of the company’s January 2007
realignment reallocating resources from genetics research efforts to drug
development.
General and Administrative
Expenses: General and administrative expenses for the three
months ended March 31, 2008 increased four percent to $5.5 million from $5.3
million for the corresponding period in 2007.
Net Loss: Net loss
for the three months ended March 31, 2008 was $18.0 million, or $0.13 per share,
compared to net loss of $18.9 million, or $0.24 per share, in the corresponding
period in 2007. Net loss included non-cash, stock-based compensation
expense of $1.8 million for the three months ended March 31, 2008 and $1.6
million for the corresponding period in 2007.
Cash and
Investments: As of March 31, 2008, Lexicon had $228.8 million
in cash and investments, including $33.4 million in cash and investments held by
Symphony Icon, as compared to $258.8 million as of December 31,
2007.
Lexicon
Conference Call:
Lexicon
management will hold a conference call to discuss its clinical development
progress and financial results for the first quarter of 2008 at 5:00 p.m.
Eastern Time on April 29, 2008. The dial-in number for the
conference call is 866-316-1364 (within the United States) or 913-312-6667
(international). The pass code for all callers is
7581545. Investors can access a live webcast of the call at www.lexpharma.com. An
archived version of the webcast will be available on the website through
May 2, 2008.
About
Lexicon
Lexicon
is a biopharmaceutical company focused on discovering and developing
breakthrough treatments for human disease. Through its proprietary
gene knockout technology, the company is dedicated to discovering and developing
breakthrough treatments for human disease. Lexicon currently has
development programs underway for such areas of major unmet medical need as
irritable bowel syndrome, cognitive disorders, autoimmune diseases, and
carcinoid syndrome. The company has used its proprietary gene
knockout technology to discover more than 100 promising drug targets and create
an extensive pipeline of clinical and preclinical programs in the therapeutic
areas of cardiology, gastroenterology, immunology and oncology, metabolism,
neurology and ophthalmology. To focus its commitment, Lexicon
initiated its 10TO10 program
to advance 10 new drug candidates into human clinical trials by the end of
2010. To advance the development and commercialization of its
programs, Lexicon is working both independently and through collaborators
including Bristol-Myers Squibb Company, Genentech, Inc. and N.V.
Organon. 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 LX6171, LX2931 and LX1032 and the
potential therapeutic and commercial potential of LX6171, LX2931 and
LX1032. 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 LX6171, LX2931 and LX1032 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:
Bobbie
Faulkner
Manager,
Investor and Public Relations
281/863-3503
bfaulkner@lexpharma.com
Lexicon
Pharmaceuticals, Inc.
Selected
Financial Data
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Consolidated
Statements of Operations Data
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Three
Months Ended
March
31,
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|||||||
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(In
thousands, except per share data)
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2008
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2007
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||||||
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(unaudited)
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Revenues:
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Collaborative research
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$ | 7,634 | $ | 12,271 | ||||
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Subscription and license fees
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1,259 | 1,224 | ||||||
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Total revenues
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8,893 | 13,495 | ||||||
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Operating
expenses:
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||||||||
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Research
and development, including stock-based compensation of
$1,127 and $991, respectively
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27,802 | 27,290 | ||||||
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General
and administrative, including stock-based compensation of
$652 and $568, respectively
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5,529 | 5,300 | ||||||
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Total operating expenses
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33,331 | 32,590 | ||||||
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Loss
from operations
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(24,438 | ) | (19,095 | ) | ||||
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Interest
income
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2,781 | 880 | ||||||
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Interest
expense
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(670 | ) | (688 | ) | ||||
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Other
expense, net
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(547 | ) | (12 | ) | ||||
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Loss
before noncontrolling interest in Symphony Icon, Inc.
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(22,874 | ) | (18,915 | ) | ||||
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Loss
attributable to noncontrolling interest in Symphony Icon, Inc.
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4,924 | — | ||||||
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Net
loss
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$ | (17,950 | ) | $ | (18,915 | ) | ||
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Net
loss per common share, basic and diluted
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$ | (0.13 | ) | $ | (0.24 | ) | ||
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Shares
used in computing net loss per common share, basic and
diluted
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136,795 | 77,938 | ||||||
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Consolidated
Balance Sheet Data
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As
of March 31,
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As
of December 31,
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||||||
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(In
thousands)
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2008
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2007
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||||||
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(unaudited)
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Cash
and investments, including cash and investments held by Symphony Icon,
Inc.
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$ | 228,796 | $ | 258,775 | ||||
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Property
and equipment, net
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69,650 | 70,829 | ||||||
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Goodwill
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25,798 | 25,798 | ||||||
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Total
assets
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336,573 | 369,296 | ||||||
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Deferred
revenue
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27,860 | 34,156 | ||||||
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Current
and long-term debt
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31,156 | 31,373 | ||||||
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Noncontrolling
interest in Symphony Icon, Inc.
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25,347 | 30,271 | ||||||
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Accumulated
deficit
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(428,485 | ) | (410,535 | ) | ||||
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Total
stockholders’ equity
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237,801 | 256,300 | ||||||