Lexicon Pharmaceuticals Provides Clinical Pipeline Update And Reports 2012 Fourth Quarter And Full Year Financial Results

  Lexicon Pharmaceuticals Provides Clinical Pipeline Update And Reports 2012
                Fourth Quarter And Full Year Financial Results

Conference Call and Webcast at 11:00 a.m. Eastern Time

PR Newswire

THE WOODLANDS, Texas, Feb. 21, 2013

THE WOODLANDS, Texas, Feb. 21, 2013 /PRNewswire/ --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, 2012.

"We continued to make significant progress in the development of our pipeline
in 2012, highlighted by positive results from clinical studies of LX4211 in
diabetes and telotristat etiprate in carcinoid syndrome," said Dr. Arthur T.
Sands, president and chief executive officer of Lexicon. "We are pleased to
have commenced the Phase 3 program for telotristat etiprate in carcinoid
syndrome, and continue to progress in our preparations for LX4211 Phase 3
initiation. We also look forward to significant proof-of-concept results in
irritable bowel syndrome (IBS) with LX1033, ulcerative colitis with
telotristat etiprate, and type 1 diabetes with LX4211 in 2013."

Key Developments in 2012

  oLX4211: Lexicon reported positive results from a 12-week Phase 2b
    clinical trial of LX4211, a dual inhibitor of sodium-glucose
    cotransporters 1 and 2 (SGLT1 and SGLT2) in patients with type 2 diabetes
    who were concurrently treated with metformin, an established diabetes
    therapy. LX4211 treatment produced substantial, dose-dependent and
    statistically-significant reductions in hemoglobin A1c (HbA1c), with
    patients in the high dose (400 mg QD) LX4211 treatment arm having a mean
    HbA1C reduction from baseline of 0.95 percent (p<0.001). In patients
    randomized to placebo, HbA1C decreased by 0.09 percent. LX4211 treatment
    also produced significant reductions in body weight and blood pressure. In
    addition, Lexicon initiated a study in type 2 diabetes patients with renal
    impairment.

  oTelotristat etiprate (LX1032): Lexicon initiated a pivotal Phase 3
    clinical trial of telotristat etiprate, an inhibitor of tryptophan
    hydroxylase that reduces peripheral serotonin production without affecting
    brain serotonin levels. The Phase 3 registrational trial is a 12-week,
    randomized, double-blind, placebo-controlled study to evaluate the
    efficacy and safety of telotristat etiprate as a new treatment for
    carcinoid syndrome that is refractory to current therapy. The study is
    expected to enroll approximately 105 patients. Lexicon reported data from
    an open-label Phase 2 trial in which telotristat etiprate showed evidence
    of clinical benefit across several endpoints in carcinoid syndrome
    patients. Benefits included reductions in bowel movement frequency,
    decreased urinary 5-HIAA (a biomarker of serotonin synthesis), and
    improvements in patient-reported relief of symptoms. Lexicon received
    Orphan Drug designation for telotristat etiprate from the U.S. Food and
    Drug Administration (FDA) for the treatment of carcinoid syndrome, having
    previously obtained Fast Track designation from the FDA and Orphan Drug
    designation from the European Medicines Agency (EMA). In addition to
    ongoing development in carcinoid syndrome, Lexicon also initiated a Phase
    2 proof-of-concept study of telotristat etiprate in patients with
    ulcerative colitis.

  oLX1033: Lexicon initiated a Phase 2 clinical trial of LX1033, an inhibitor
    of tryptophan hydroxylase that acts locally in the gastrointestinal tract
    to reduce serotonin production, in patients with diarrhea-predominant IBS
    (IBS-d). The Phase 2 trial is a randomized, double-blind,
    placebo-controlled study designed to evaluate the safety and efficacy of
    LX1033 in approximately 360 IBS-d patients. Lexicon also received Fast
    Track status from the FDA for the development of LX1033 in IBS-d.

  oOther Programs: Lexicon obtained results from Phase 1 studies of LX2931,
    an inhibitor of sphingosine-1-phosphate lyase, in patients with rheumatoid
    arthritis, and LX7101, an inhibitor of LIM domain kinase 2 (LIMK2), in
    patients with glaucoma. Both compounds were well-tolerated and showed
    signals of clinical benefit in the respective studies.

Financial Results

Revenues: Lexicon's revenues for the three months ended December 31, 2012
decreased 36 percent to $0.2 million from $0.3 million for the corresponding
period in 2011. For the year ended December 31, 2012, revenues decreased 41
percent to $1.1 million from $1.8 million for the corresponding period in
2011.

Research and Development Expenses: Research and development expenses for the
three months ended December 31, 2012 decreased 25 percent to $21.0 million
from $28.1 million for the corresponding period in 2011, primarily due to a
decrease in external manufacturing, clinical research and development costs.
For the year ended December 31, 2012, research and development expenses
decreased 10 percent to $82.6 million from $91.8 million for the corresponding
period in 2011.

Increase (Decrease) in Fair Value of Symphony Icon Purchase Liability: In
connection with the acquisition of Symphony Icon, Lexicon made an initial
estimate of the fair value of the liability for the associated base and
contingent payments. Changes in this liability, based on the development of
the programs and the time until such payments are expected to be made, are
recorded in Lexicon's consolidated statements of operations. For the three
months ended December 31, 2012, the fair value of the Symphony Icon purchase
liability decreased by $0.2 million, compared to an increase of $1.6 million
in the corresponding period in 2011. For the years ended December 31, 2012 and
2011, the increase in fair value of the Symphony Icon purchase liability was
$9.9 million and $6.8 million, respectively.

General and Administrative Expenses: General and administrative expenses for
the three months ended December 31, 2012 decreased two percent to $3.9 million
from $4.0 million for the corresponding period in 2011. For the year ended
December 31, 2012, general and administrative expenses decreased two percent
to $17.0 million from $17.4 million for the corresponding period in 2011.

Consolidated Net Loss: Net loss for the three months ended December 31, 2012
was $24.9 million, or $0.05 per share, compared to a net loss of $33.8
million, or $0.10 per share, in the corresponding period in 2011. Net loss for
the year ended December 31, 2012 was $110.2 million, or $0.23 per share,
compared to a net loss of $116.2 million, or $0.34 per share, for the
corresponding period in 2011. For the three months and year ended December 31,
2012, net loss included non-cash, stock-based compensation expense of $1.6
million and $6.5 million, respectively. For the three months and year ended
December 31, 2011, net loss included non-cash, stock-based compensation
expense of $1.4 million and $5.7 million, respectively.

Cash and Investments: As of December 31, 2012, Lexicon had $223.2 million in
cash and investments, as compared to cash and investments of $206.8 million as
of September 30, 2012 and $281.7 million as of December 31, 2011.

Lexicon Conference Call
Lexicon management will hold a conference call to discuss its clinical
development progress and financial results for 2012 and financial guidance for
2013 at 11:00 a.m. Eastern Time on February 21, 2013. The dial-in number for
the conference call is 888-645-5785 (within the US/Canada) or 970-300-1531
(international). The conference ID for all callers is 12316846. 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 March 21, 2013.

About Lexicon
Lexicon is a biopharmaceutical company focused on discovering breakthrough
treatments for human disease. Lexicon currently has multiple drug programs in
clinical development for diabetes, irritable bowel syndrome, carcinoid
syndrome and other indications, 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 www.lexpharma.com.

Safe Harbor Statement

This press release contains "forward-looking statements", including statements
relating to Lexicon's clinical development of LX4211, telotristat etiprate
(LX1032), LX1033, LX2931 and LX7101, including characterizations of the
results of and projected timing of clinical trials of such compounds, and the
potential therapeutic and commercial potential of LX4211, telotristat etiprate
(LX1032), LX1033, LX2931 and LX7101. In addition, 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
LX4211, telotristat etiprate (LX1032), LX1033, LX2931 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
"Risk Factors" in Lexicon's annual report on Form 10-K for the year ended
December 31, 2011, 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  Three Months Ended        Year Ended
Operations Data
                            December 31,              December 31,
(In thousands, except per   2012         2011         2012         2011
share data)
                            (unaudited)                (unaudited)
Revenues:
 Collaborative       $         $         $         $   1,632
research                    218         320         783
 Subscription and    -            23           306          217
license fees
 Total        218          343          1,089        1,849
revenues
Operating expenses:
Research and development,
including stock-based
compensation                20,990       28,107       82,574       91,828

of $798, $769, $3,673 and
$3,249, respectively
Increase (decrease) in fair
value of Symphony Icon, Inc (200)        1,568        9,887        6,766
purchase liability
General and administrative,
including stock-based
compensation                3,920        4,010        17,043       17,350

of $792, $584, $2,822 and
$2,458, respectively
 Total        24,710       33,685       109,504      115,944
operating expenses
Loss from operations        (24,492)     (33,342)     (108,415)    (114,095)
Interest income             55           40           213          255
Interest expense            (520)        (551)        (2,114)      (2,528)
Other income, net           84           8            105          153
Consolidated net loss       $ (24,873)  $ (33,845)  $ (110,211)  $ (116,215)
Consolidated net loss per   $          $          $          $  
common share, basic and     (0.05)       (0.10)       (0.23)       (0.34)
diluted
Shares used in computing
consolidated net loss per   507,619      350,069      489,707      340,761
common share, basic and
diluted

Consolidated Balance Sheet Data As of December 31,  As of December 31,
(In thousands)                  2012                2011
                                (unaudited)
Cash and investments            $   223,208       $   281,692
Property and equipment, net     42,634              46,417
Goodwill                   44,543              44,543
Other intangible assets         53,557              53,557
Total assets                    371,778             430,512
Deferred revenue                14,038              14,331
Current and long-term debt      23,451              24,894
Other long-term liabilities     32,283              55,146
Accumulated deficit             (899,832)           (789,621)
Total stockholders' equity      266,678             297,568

SOURCE Lexicon Pharmaceuticals, Inc.

Website: http://www.lexpharma.com
Contact: Alex Abuin, Ph.D., Lexicon, Vice President, Communications and
Alliance Management, +1-281-863-3213, aabuin@lexpharma.com
 
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