Conference Call and Webcast at 11:00 a.m. Eastern Time THE
WOODLANDS, Texas, Oct. 27 /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 and nine months ended
September 30, 2009. "We advanced our fourth drug candidate into
Phase 2 clinical trials during the third quarter, as we continue to
focus our resources on the research and development of our most
promising programs," said Dr. Arthur T. Sands, president and chief
executive officer of Lexicon. "We are now looking forward to
reporting Phase 2 clinical results from our four programs in
patients over the next 12 months, including top-line results from
LX1031 in November 2009." Key Developments -- Lexicon completed
patient enrollment ahead of schedule in a Phase 2a clinical trial
of its drug candidate for non-constipating irritable bowel syndrome
(IBS), LX1031, an inhibitor of tryptophan hydroxylase that acts
locally in the gastrointestinal tract. Top-line data from the trial
is expected to be available in November 2009, with detailed results
available in the first quarter of 2010. -- Lexicon completed Phase
1 studies of its drug candidate for type 2 diabetes, LX4211, an
inhibitor of sodium-glucose cotransporter 2 (SGLT2). The company
also initiated a Phase 2a clinical trial of the drug candidate in
patients with diabetes. In the Phase 1 clinical trial, LX4211 was
well tolerated at all dose levels and produced a dose-dependent
increase in urinary glucose excretion. LX4211 also demonstrated a
favorable pharmacokinetic profile supporting the potential for once
daily dosing. The Phase 2 clinical trial is designed as a
four-week, randomized, double-blind, placebo-controlled study to
evaluate the safety and tolerability of LX4211 and its effect on
biomarkers associated with type 2 diabetes. The trial will be
conducted in the United States and is expected to enroll 36
patients with non-insulin dependent type 2 diabetes. Top-line data
from the trial is expected to be available in the first quarter of
2010. -- 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. The study
will include up to 120 patients and will be conducted at multiple
centers in the United States and Eastern Europe. Top-line data from
the trial is expected to be available in the third quarter of 2010.
-- 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
will include up to 28 patients with carcinoid syndrome who are
symptomatic despite treatment with currently available therapy.
Top-line data from the trial is expected to be available by the
third quarter 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. Financial Results Revenues: Lexicon's revenues for the
three months ended September 30, 2009 decreased 72 percent to $2.1
million from $7.5 million for the corresponding period in 2008. The
decrease was primarily attributable to reduced revenues under
Lexicon's alliances with Bristol-Myers Squibb, N.V. Organon and
Genentech, Inc., partially offset by increases in revenue under the
company's collaboration with Taconic Farms, Inc. For the nine
months ended September 30, 2009, revenues decreased 64 percent to
$9.3 million from $26.0 million for the corresponding period in
2008. Research and Development Expenses: Research and development
expenses for the three months ended September 30, 2009 decreased 29
percent to $19.3 million from $27.3 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. For the nine months ended September
30, 2009, research and development expenses decreased 26 percent to
$62.4 million from $84.9 million for the corresponding period in
2008. General and Administrative Expenses: General and
administrative expenses for the three months ended September 30,
2009 decreased eight percent to $4.6 million from $5.0 million for
the corresponding period in 2008. The decrease was primarily
attributable to lower consulting expenses. For the nine months
ended September 30, 2009, general and administrative expenses
decreased 10 percent to $15.0 million from $16.7 million for the
corresponding period in 2008. Net Loss Attributable to Lexicon
Pharmaceuticals, Inc.: Net loss for the three months ended
September 30, 2009 was $19.1 million, or $0.14 per share, compared
to a net loss of $23.5 million, or $0.17 per share, in the
corresponding period in 2008. Net loss for the nine months ended
September 30, 2009 was $60.8 million, or $0.44 per share, compared
to a net loss of $61.4 million, or $0.45 per share, for the
corresponding period in 2008. For the three and nine months ended
September 30, 2009, net loss included non-cash, stock-based
compensation expense of $1.3 million and $4.1 million,
respectively. For the three and nine months ended September 30,
2008, net loss included non-cash, stock-based compensation expense
of $1.4 million and $4.8 million, respectively. Cash and
Investments: As of September 30, 2009, Lexicon had $87.3 million in
cash and investments net of its obligations under the credit line
secured by its auction rate securities, as compared to $106.9
million as of June 30, 2009 and $158.8 million as of December 31,
2008. The $87.3 million in cash and investments as of September 30,
2009 does not include the $55.2 million in net proceeds the company
recently received from its public offering in October 2009. Lexicon
Conference Call: Lexicon management will hold a conference call to
discuss its clinical development progress and financial results for
the third quarter of 2009 at 11:00 a.m. Eastern Time on October 27,
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 17788499. 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
November 2, 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 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 Three Months
Ended Nine Months Ended of Operations Data September 30, September
30, ------------- ------------- (In thousands, except per share
data) 2009 2008 2009 2008 ---- ---- ---- ---- (unaudited)
(unaudited) Revenues: Collaborative research $1,650 $7,202 $8,042
$22,789 Subscription and license fees 481 310 1,246 3,182 --- ---
----- ----- Total revenues 2,131 7,512 9,288 25,971 Operating
expenses: Research and development, including stock-based
compensation of $733, $836, $2,328 and $2,913, respectively 19,320
27,344 62,404 84,868 General and administrative, including
stock-based compensation of $547, $583, $1,750 and $1,868,
respectively 4,568 4,990 14,993 16,749 ----- ----- ------ ------
Total operating expenses 23,888 32,334 77,397 101,617 ------ ------
------ ------- Loss from operations (21,757) (24,822) (68,109)
(75,646) Gain (loss) on investments, net 185 (3,322) 1,008 (3,322)
Interest income 103 956 669 5,155 Interest expense (785) (675)
(2,180) (2,020) Other expense, net (516) (535) (2,037) (1,621) ----
---- ------ ------ Consolidated loss before income taxes (22,770)
(28,398) (70,649) (77,454) Income tax benefit 102 - 102 - --- ---
--- --- Consolidated net loss (22,668) (28,398) (70,547) (77,454)
Loss attributable to noncontrolling interest in Symphony Icon, Inc.
3,526 4,939 9,772 16,011 ----- ----- ----- ------ Net loss
attributable to Lexicon Pharmaceuticals, Inc. $(19,142) $(23,459)
$(60,775) $(61,443) ======== ======== ======== ======== Net loss
attributable to Lexicon Pharmaceuticals, Inc. per common share,
basic and diluted $(0.14) $(0.17) $(0.44) $(0.45) ====== ======
====== ====== Shares used in computing net loss attributable to
Lexicon Pharmaceuticals, Inc. per common share, basic and diluted
137,313 136,796 137,240 136,796 Consolidated Balance Sheet Data As
of As of September 30, December 31, (In thousands) 2009 2008 ----
---- (unaudited) Cash and investments, including cash and
investments held by Symphony Icon, Inc. $125,146 $158,798
Obligations under line of credit (37,835) - ------- --- Cash and
investments, net of obligations under line of credit 87,311 158,798
Property and equipment, net 60,090 65,087 Goodwill 25,798 25,798
Total assets 223,684 261,508 Deferred revenue 15,293 19,884 Current
and long-term debt, including line of credit 67,614 30,492
Noncontrolling interest in Symphony Icon, Inc. 475 10,247
Accumulated deficit (548,170) (487,395) Total Lexicon
Pharmaceuticals, Inc. stockholders' equity 129,424 185,580
DATASOURCE: Lexicon Pharmaceuticals, Inc. CONTACT: Jason Ray,
Manager, Corporate Communications and Investor Relations of Lexicon
Pharmaceuticals, Inc., +1-281-863-3225, Web Site:
http://www.lexpharma.com/
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