THE WOODLANDS, Texas,
Nov. 1, 2011 /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 and nine months ended
September 30, 2011.
"Recent positive results from clinical studies of LX4211 and
LX1032 have provided further validation for the unique mechanisms
of action of these first-in-class drugs," said Dr. Arthur T. Sands,
president and chief executive officer of Lexicon. "We are
progressing with plans to partner LX1032 on the strength of our
Phase 2 data in carcinoid syndrome, and are engaged in active
discussions with multiple parties about the program."
Progress in Clinical Pipeline
- Telotristat etiprate (LX1032): Results from the
recently-completed placebo-controlled Phase 2 clinical trial of
telotristat etiprate in carcinoid syndrome patients were reported
at the annual meeting of the North American Neuroendocrine Tumor
Society. Telotristat etiprate, an inhibitor of tryptophan
hydroxylase that reduces peripheral serotonin production without
affecting brain serotonin levels, showed evidence of efficacy
across several endpoints, including observed reductions in bowel
movement frequency; decreased urinary 5-HIAA, a biomarker of
serotonin synthesis; and improvements in patient-reported relief of
symptoms. Also reported were preliminary data from an ongoing
open-label Phase 2 trial, which indicate that telotristat etiprate
is producing biochemical and clinical benefits, including
improvements in bowel movement frequency, flushing episode
frequency, urinary 5-HIAA levels, and adequate relief of
gastrointestinal symptoms. The drug has demonstrated a
favorable safety profile in both studies to date. In addition
to the ongoing development of telotristat etiprate for carcinoid
syndrome, Lexicon also plans to initiate a Phase 2 trial in
patients with ulcerative colitis in the fourth quarter of this
year.
- LX4211: Lexicon reported data from a clinical study in
which LX4211, a dual inhibitor of sodium-glucose cotransporters 1
and 2, demonstrated a favorable safety profile and beneficial
effects on multiple parameters of glycemic control and
cardiovascular health in healthy normal subjects, including
decreased postprandial glucose levels without hypoglycemia and
substantially reduced triglycerides. Lexicon also presented
data from a previous mechanistic study in patients with type 2
diabetes at the annual meeting of the European Association for the
Study of Diabetes, which demonstrated that a single dose of LX4211
significantly increased circulating levels of GLP-1 (active and
total) and PYY, important regulators of glycemic and appetite
control. Lexicon continues to enroll patients with type 2
diabetes in its 12-week Phase 2b clinical trial of LX4211, which
remains on track to complete on schedule, with top-line results
expected around mid-year 2012.
- LX1033: Lexicon is preparing to initiate a Phase 2 study
of LX1033, a serotonin synthesis inhibitor being developed as a
potential treatment for irritable bowel syndrome (IBS). In a
Phase 1 study completed earlier this year in healthy volunteers,
LX1033 produced reductions in 5-HIAA, a biomarker of serotonin
production, comparable to those seen with an earlier clinical
compound, LX1031, but with substantially lower and less frequent
dosing. Results from a Phase 2 study published in the
August 2011 issue of the journal
Gastroenterology showed that LX1031 was well tolerated and
provided clinical benefit to patients with non-constipating IBS,
showing improvements in a global assessment of adequate relief from
IBS pain and discomfort and in stool consistency, with symptom
relief correlating with reductions in the 5-HIAA biomarker.
Like LX1031, LX1033 acts locally in the gastrointestinal
tract to reduce serotonin production by inhibiting tryptophan
hydroxylase, a key enzyme in the biosynthesis of serotonin.
- LX2931: Lexicon initiated a dose-ranging study to explore
higher doses of LX2931 in rheumatoid arthritis patients.
Previously-reported Phase 2a results of LX2931, an inhibitor
of sphingosine-1-phosphate lyase, demonstrated a favorable safety
profile at all doses tested and suggest that rheumatoid arthritis
patients treated with 150 mg of LX2931 once daily showed
improvement in the primary efficacy endpoint of the study, the
percentage of patients achieving an American College of
Rheumatology 20 (ACR20) response at week 12.
Financial Results
Revenues: Lexicon's revenues for the three months
ended September 30, 2011 decreased 55
percent to $0.4 million from
$0.8 million for the corresponding
period in 2010. For the nine months ended September 30, 2011, revenues decreased 59 percent
to $1.5 million from $3.7 million for the corresponding period in
2010.
Research and Development Expenses: Research and
development expenses for the three months ended September 30, 2011 increased 4 percent to
$19.7 million from $18.9 million for the corresponding period in
2010, primarily due to an increase in external preclinical and
clinical research and development costs, offset by a decrease in
personnel costs. For the nine months ended September 30, 2011, research and development
expenses increased 6 percent to $63.7
million from $60.3 million for
the corresponding period in 2010.
Increase 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.
The increase in fair value of the Symphony Icon purchase
liability was $2.3 million and
$1.1 million for the three months
ended September 30, 2011 and 2010,
respectively, and was $5.2 million
and $1.1 million for nine months
ended September 30, 2011 and 2010,
respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended September 30, 2011 decreased 18 percent to
$4.1 million from $4.9 million for the corresponding period in
2010. The decrease was primarily attributable to decreased
personnel costs. For the nine months ended September 30, 2011, general and administrative
expenses decreased 14 percent to $13.3
million from $15.5 million for
the corresponding period in 2010.
Consolidated Net Loss: Net loss for the three
months ended September 30, 2011 was
$26.1 million, or $0.08 per share, compared to a net loss of
$27.5 million, or $0.08 per share, in the corresponding period in
2010. Net loss for the nine months ended September 30, 2011 was $82.4 million, or $0.24 per share, compared to a net loss of
$78.8 million, or $0.27 per share, for the corresponding period in
2010. For the three and nine months ended September 30, 2011, net loss included non-cash,
stock-based compensation expense of $1.4
million and $4.4 million,
respectively. For the three and nine months ended
September 30, 2010, net loss included
non-cash, stock-based compensation expense of $1.3 million and $4.0
million, respectively.
Cash and Investments: As of September 30, 2011, Lexicon had $144.2 million in cash and investments, as
compared to $164.8 million as of
June 30, 2011 and $211.1 million as of December 31, 2010.
Lexicon Conference Call:
Lexicon management will hold a conference call to discuss its
clinical development progress and financial results for the third
quarter of 2011 at 11:00 a.m. Eastern
Time today. 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 20122666.
Investors can access a live webcast of the call at
www.lexpharma.com. An archived version of the webcast will be
available on Lexicon's corporate website through November 29, 2011.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering
breakthrough treatments for human disease. Lexicon currently
has four drug programs in mid-stage development for diabetes,
irritable bowel syndrome, carcinoid syndrome and rheumatoid
arthritis, 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 LX1031, LX1032, LX1033, LX2931, and LX4211, including
characterizations of the results of and projected timing of
clinical trials of such compounds, and the potential therapeutic
and commercial potential of LX1031, LX1032, LX1033, LX2931, and
LX4211. This press release also contains forward-looking
statements relating to Lexicon's partnership discussions with third
parties with respect to the development and commercialization of
LX1032. 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 LX1031,
LX1032, LX1033, 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, including with respect to LX1032, 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. Unless
specifically indicated otherwise, results reported as trends were
not statistically significant. 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, 2010, 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
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
(In
thousands, except per share data)
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Collaborative
research
|
|
$ 335
|
|
$ 632
|
|
$ 1,312
|
|
$ 3,437
|
|
Subscription and license
fees
|
|
20
|
|
149
|
|
194
|
|
218
|
|
Total
revenues
|
|
355
|
|
781
|
|
1,506
|
|
3,655
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development,
including stock-based compensation
of $823, $751, $2,480 and
$2,366, respectively
|
|
19,655
|
|
18,941
|
|
63,721
|
|
60,268
|
|
Increase in fair value of
Symphony Icon, Inc. purchase liability
|
|
2,336
|
|
1,145
|
|
5,198
|
|
1,145
|
|
General and
administrative, including stock-based compensation
of $609, $582, $1,874 and
$1,592, respectively
|
|
4,055
|
|
4,948
|
|
13,340
|
|
15,535
|
|
Total
operating expenses
|
|
26,046
|
|
25,034
|
|
82,259
|
|
76,948
|
|
Loss from operations
|
|
(25,691)
|
|
(24,253)
|
|
(80,753)
|
|
(73,293)
|
|
Gain on investments, net
|
|
-
|
|
-
|
|
-
|
|
141
|
|
Interest income
|
|
60
|
|
51
|
|
215
|
|
468
|
|
Interest expense
|
|
(560)
|
|
(637)
|
|
(1,977)
|
|
(2,093)
|
|
Other income (expense),
net
|
|
88
|
|
(2,700)
|
|
145
|
|
(4,025)
|
|
Consolidated loss before income
taxes
|
|
(26,103)
|
|
(27,539)
|
|
(82,370)
|
|
(78,802)
|
|
Income tax benefit
|
|
-
|
|
26
|
|
-
|
|
26
|
|
Consolidated net loss
|
|
$
(26,103)
|
|
$
(27,513)
|
|
$
(82,370)
|
|
$
(78,776)
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss per common
share, basic and diluted
|
|
$ (0.08)
|
|
$ (0.08)
|
|
$ (0.24)
|
|
$ (0.27)
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net
loss attributable to Lexicon Pharmaceuticals, Inc. per common
share, basic and diluted
|
|
337,678
|
|
337,404
|
|
337,625
|
|
291,196
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data
|
As of
September 30,
|
|
As of
December 31,
|
|
(In
thousands)
|
2011
|
|
2010
|
|
|
(unaudited)
|
|
|
|
Cash and investments
|
$ 144,155
|
|
$ 211,111
|
|
Property and equipment,
net
|
47,344
|
|
53,427
|
|
Goodwill
|
44,543
|
|
44,543
|
|
Other intangible assets
|
53,557
|
|
53,557
|
|
Total assets
|
294,706
|
|
366,884
|
|
Deferred revenue
|
14,376
|
|
14,426
|
|
Current and long-term
debt
|
25,239
|
|
28,483
|
|
Other long-term
liabilities
|
53,636
|
|
48,783
|
|
Accumulated deficit
|
(755,776)
|
|
(673,406)
|
|
Total stockholders'
equity
|
169,481
|
|
247,024
|
|
——————
|
|
|
|
|
|
|
|
|
|
|
SOURCE Lexicon Pharmaceuticals, Inc.