Conference Call and Webcast at 11:00 a.m. Eastern Time THE
WOODLANDS, Texas, Feb. 23 /PRNewswire-FirstCall/ -- 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, 2009. "We have now established proof-of-concept for
two of our four clinical programs, with positive results in Phase 2
clinical trials for both LX1031 in IBS and LX4211 in type 2
diabetes," said Dr. Arthur T. Sands, president and chief executive
officer of Lexicon. "We look forward to reporting Phase 2 clinical
results from our next two programs, LX2931 for rheumatoid arthritis
and LX1032 for carcinoid syndrome." Key Developments of 2009 --
Lexicon reported positive results from the Phase 2a clinical trial
of its drug candidate for non-constipating irritable bowel syndrome
(IBS), LX1031, an inhibitor of tryptophan hydroxylase that acts
locally to reduce serotonin synthesis in the gastrointestinal
tract. Top-line data demonstrated that the high dose of LX1031
produced statistically-significant improvements in a global
assessment of relief of IBS pain and discomfort and in stool
consistency as compared to placebo -- clinical benefits that
correspond with a reduction in serotonin synthesis. -- Lexicon
completed Phase 2a studies of its drug candidate for type 2
diabetes, LX4211, an inhibitor of sodium-glucose cotransporter 2
(SGLT2). Top-line data from the Phase 2a trial, reported in January
2010, showed statistically-significant and rapid improvements in
multiple parameters in patients with type 2 diabetes, including
improved glycemic control and reduced HbA1c within four weeks. In
addition, reductions in weight, blood pressure, and triglyceride
levels were observed for both treatment arms relative to placebo.
-- Lexicon advanced LX2931, an inhibitor of sphingosine-1-phosphate
(S1P) lyase, into a Phase 2a study in patients with rheumatoid
arthritis. The Phase 2 clinical trial is designed as a 12-week,
randomized, double-blind, placebo-controlled study to evaluate the
safety and tolerability of LX2931 and its effects on symptoms
associated with rheumatoid arthritis. With enrollment in the study
proceeding ahead of schedule, the Company has filed for regulatory
authorization to permit enrollment of up to 200 patients, an
increase from the originally-planned enrollment of up to 120
patients, which will increase the likelihood of observing a
positive statistical trend. The study is being conducted at
multiple centers in the United States and Eastern Europe. Top-line
data from the expanded trial are expected to be available around
the end of the year. -- Lexicon continues to enroll patients in a
Phase 2a study of its drug candidate for carcinoid syndrome,
LX1032, an inhibitor of tryptophan hydroxylase that reduces
peripheral serotonin production without affecting brain serotonin
levels. The Phase 2 clinical trial is designed as a randomized,
double-blind, placebo-controlled study to evaluate the safety and
tolerability of LX1032 and its effects on symptoms associated with
carcinoid syndrome. The study is expected to include up to 28
patients with carcinoid syndrome who are symptomatic despite
treatment with currently available therapy. Top-line data from the
trial are expected to be available in the second half of 2010. --
In October 2009, Lexicon completed the public offering and sale of
38.3 million shares of its common stock at $1.50 per share. The net
proceeds of the offering were $55.2 million, after deducting
underwriting discounts and offering expenses. LX1031 and LX1032 are
being developed in a product development collaboration with
Symphony Capital Partners, L.P. and its co-investors. Financial
Results Revenues: Lexicon's revenues for the three months ended
December 31, 2009 decreased 78 percent to $1.4 million from $6.4
million for the corresponding period in 2008. The decrease was
primarily attributable to reduced revenues under Lexicon's
alliances with N.V. Organon, Bristol-Myers Squibb and Genentech,
Inc., partially offset by increases in revenue under the company's
collaboration with Taconic Farms, Inc. For the year ended December
31, 2009, revenues decreased 67 percent to $10.7 million from $32.3
million for the corresponding period in 2008. Research and
Development Expenses: Research and development expenses for the
three months ended December 31, 2009 decreased 16 percent to $18.8
million from $22.4 million for the corresponding period in 2008.
The decrease was primarily attributable to lower external
preclinical research and development expenses as well as lower
salary and benefit costs, partially offset by higher external
clinical research and development expenses. For the year ended
December 31, 2009, research and development expenses decreased 24
percent to $81.2 million from $107.2 million for the corresponding
period in 2008. General and Administrative Expenses: General and
administrative expenses for the three months ended December 31,
2009 decreased nine percent to $4.4 million from $4.9 million for
the corresponding period in 2008. The decrease was primarily
attributable to lower consulting and stock-based compensation
expenses. For the year ended December 31, 2009, general and
administrative expenses decreased 10 percent to $19.4 million from
$21.6 million for the corresponding period in 2008. Net Loss
Attributable to Lexicon Pharmaceuticals, Inc.: Net loss for the
three months ended December 31, 2009 was $22.0 million, or $0.13
per share, compared to a net loss of $15.4 million, or $0.11 per
share, in the corresponding period in 2008. Net loss for the year
ended December 31, 2009 was $82.8 million, or $0.57 per share,
compared to a net loss of $76.9 million, or $0.56 per share, for
the corresponding period in 2008. For the three months and year
ended December 31, 2009, net loss included non-cash, stock-based
compensation expense of $1.2 million and $5.3 million,
respectively. For the three months and year ended December 31,
2008, net loss included non-cash, stock-based compensation expense
of $1.7 million and $6.5 million, respectively. Cash and
Investments: As of December 31, 2009, Lexicon had $125.1 million in
cash and investments net of its obligations under the credit line
secured by its auction rate securities, as compared to $87.3
million as of September 30, 2009 and $158.8 million as of December
31, 2008. Lexicon Conference Call: Lexicon management will hold a
conference call to discuss its clinical development progress and
financial results for 2009 and financial guidance for 2010 at 11:00
a.m. Eastern Time on February 23, 2010. 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
57354686. Investors can access a live webcast of the call at
http://www.lexpharma.com/. An archived version of the webcast will
be available on the website through March 2, 2010. 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 Lexicon's research team.
Lexicon 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 http://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, and LX4211 and the potential therapeutic and commercial
potential of LX1031, LX1032, LX2931, and LX4211. 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, and LX4211 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, 2008, 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. Lexicon Pharmaceuticals,
Inc. Selected Financial Data Consolidated Statements of Operations
Data (In thousands, except Three Months Ended Year Ended per share
data) December 31, December 31, --------------------
-------------------- 2009 2008 2009 2008 -------- -------- --------
-------- (unaudited) (unaudited) Revenues: Collaborative research
$1,292 $4,388 $9,334 $27,177 Subscription and license fees 120
1,962 1,366 5,144 -------- -------- -------- -------- Total
revenues 1,412 6,350 10,700 32,321 Operating expenses: Research and
development, including stock-based compensation of $694, $1,028,
$3,022 and $3,941, respectively 18,834 22,364 81,238 107,232
General and administrative, including stock-based compensation of
$502, $691, $2,252 and $2,559, respectively 4,425 4,875 19,418
21,624 -------- -------- -------- -------- Total operating expenses
23,259 27,239 100,656 128,856 -------- -------- -------- --------
Loss from operations (21,847) (20,889) (89,956) (96,535) Gain
(loss) on investments, net 165 2,008 1,173 (1,314) Interest income
211 607 880 5,762 Interest expense (786) (671) (2,966) (2,691)
Other expense, net (513) (485) (2,550) (2,106) -------- --------
-------- -------- Consolidated loss before income taxes (22,770)
(19,430) (93,419) (96,884) Income tax benefit - - 102 - --------
-------- -------- -------- Consolidated net loss (22,770) (19,430)
(93,317) (96,884) Loss attributable to noncontrolling interest in
Symphony Icon, Inc. 765 4,013 10,537 20,024 -------- --------
-------- -------- Net loss attributable to Lexicon Pharmaceuticals,
Inc. $(22,005) $(15,417) $(82,780) $(76,860) ======== ========
======== ======== Net loss attributable to Lexicon Pharmaceuticals,
Inc. per common share, basic and diluted $(0.13) $(0.11) $(0.57)
$(0.56) ======== ======== ======== ======== Shares used in
computing net loss attributable to Lexicon Pharmaceuticals, Inc.
per common share, basic and diluted 169,872 136,797 145,465 136,797
Consolidated Balance Sheet Data (In thousands) As of As of December
31, December 31, 2009 2008 ------------ ------------ (unaudited)
Cash and investments, including cash and investments held by
Symphony Icon, Inc. $162,513 $158,798 Obligations under line of
credit (37,435) - -------- -------- Cash and investments, net of
obligations under line of credit 125,078 158,798 Property and
equipment, net 58,754 65,087 Goodwill 25,798 25,798 Total assets
257,761 261,508 Deferred revenue 15,154 19,884 Current and
long-term debt, including line of credit 66,964 30,492
Noncontrolling interest in Symphony Icon, Inc. (290) 10,247
Accumulated deficit (570,175) (487,395) Total Lexicon
Pharmaceuticals, Inc. stockholders' equity 163,787 185,580
DATASOURCE: Lexicon Pharmaceuticals, Inc. CONTACT: D. Wade Walke,
Director, Corporate Communications of Lexicon Pharmaceuticals,
Inc., +1-281-863-3046, Web Site: http://www.lexpharma.com/
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