THE WOODLANDS, Texas,
Feb. 22, 2012 /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, 2011.
"We made substantial progress with our drug pipeline in 2011,
highlighted by the positive results obtained from clinical studies
of LX4211 in diabetes and LX1032 in carcinoid syndrome," said Dr.
Arthur T. Sands, president and chief executive officer of Lexicon.
"Our research has continued to reveal the favorable physiological
effects that are triggered by therapy with these investigational
drug candidates."
Key Developments
- LX4211: Enrollment is complete for the ongoing 12-week
Phase 2b study of LX4211, a dual inhibitor of sodium-glucose
cotransporters 1 and 2, with top-line data expected by mid-2012. In
2011, Lexicon reported data from a clinical study in which LX4211
demonstrated a favorable safety profile and beneficial effects on
multiple parameters of glycemic control and cardiovascular health
in healthy 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. In addition,
Lexicon completed a single dose mechanistic and pharmacokinetic
study in combination with sitagliptin (Januvia®) that demonstrated
complementary effects, increasing active GLP-1 and lowering
post-prandial glucose. Lexicon is initiating a study in type 2
diabetes patients with renal impairment.
- Telotristat etiprate (LX1032): Telotristat etiprate, an
inhibitor of tryptophan hydroxylase that reduces peripheral
serotonin production without affecting brain serotonin levels,
showed evidence of efficacy across several endpoints in carcinoid
syndrome. Benefits included reductions in bowel movement frequency,
decreased urinary 5-HIAA (a biomarker of serotonin synthesis), and
improvements in patient-reported relief of symptoms. Results from
the placebo-controlled Phase 2 clinical trial were presented at the
annual meeting of the North American Neuroendocrine Tumor Society.
Also reported were preliminary data from an ongoing open-label
Phase 2 trial, which suggest that telotristat etiprate is producing
sustained benefits, including improvements in bowel movement
frequency, flushing episode frequency, urinary 5-HIAA levels, and
adequate relief of gastrointestinal symptoms. The drug candidate
has demonstrated a favorable safety profile in both studies to
date. In addition to the ongoing development of telotristat
etiprate for carcinoid syndrome, Lexicon has initiated a Phase 2,
proof-of-concept trial in patients with ulcerative colitis. Lexicon
is currently planning for FDA and EMA meetings as well as making
preparations for registrational trials of telotristat etiprate in
carcinoid syndrome.
- LX1033: In a Phase 1 study in healthy volunteers, LX1033,
a serotonin synthesis inhibitor being developed as a treatment for
irritable bowel syndrome (IBS), produced reductions in a biomarker
of serotonin production (5-HIAA) 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,
demonstrating 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. Lexicon has recently
initiated a Phase 2 study of LX1033 in patients with IBS.
- LX2931: 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. Lexicon initiated a
dose-ranging study to explore higher doses of LX2931 in rheumatoid
arthritis patients, with results anticipated in the second quarter
of 2012.
- LX7101: In the fourth quarter of 2011, Lexicon filed an
investigational new drug application for LX7101, and expects to
commence a proof-of-concept clinical trial in patients with
glaucoma in the first quarter of 2012. LX7101 acts through a novel
mechanism of action that decreases intraocular pressure by allowing
more fluid to flow through the trabecular meshwork of the anterior
chamber of the eye.
Financial Results
Revenues: Lexicon's revenues for the three months
ended December 31, 2011 decreased 73
percent to $0.3 million from
$1.3 million for the corresponding
period in 2010. For the year ended December
31, 2011, revenues decreased 62 percent to $1.8 million from $4.9
million for the corresponding period in 2010.
Research and Development Expenses: Research and
development expenses for the three months ended December 31, 2011 increased 54 percent to
$28.1 million from $18.3 million for the corresponding period in
2010, primarily due to an increase in external manufacturing,
clinical research and development costs. For the year ended
December 31, 2011, research and
development expenses increased 17 percent to $91.8 million from $78.5
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. For the three
months ended December 31, 2011, the
increase in fair value of the Symphony Icon purchase liability was
$1.6 million, consistent with the
corresponding period in 2010. For the years ended December 31, 2011 and 2010, the increase in fair
value of the Symphony Icon purchase liability was $6.8 million and $2.7
million, respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended December 31, 2011 increased four percent to
$4.0 million from $3.9 million for the corresponding period in
2010. For the year ended December 31,
2011, general and administrative expenses decreased 11
percent to $17.4 million from
$19.4 million for the corresponding
period in 2010.
Consolidated Net Loss: Net loss for the three
months ended December 31, 2011 was
$33.8 million, or $0.10 per share, compared to a net loss of
$23.0 million, or $0.07 per share, in the corresponding period in
2010. Net loss for the year ended December
31, 2011 was $116.2 million,
or $0.34 per share, compared to a net
loss of $101.8 million, or
$0.34 per share, for the
corresponding period in 2010. 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. For the three months and year ended
December 31, 2010, net loss included
non-cash, stock-based compensation expense of $1.5 million and $5.5
million, respectively.
Cash and Investments: As of December 31, 2011, Lexicon had $281.7 million in cash and investments, as
compared to cash and investments of $144.2
million as of September 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 2011 and
financial guidance for 2012 at 11:00 a.m.
Eastern Time on February 22,
2012. 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 53392469. 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 23, 2012.
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, LX4211 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 LX1031, LX1032, LX1033, LX2931, LX4211
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 LX1031,
LX1032, LX1033, LX2931, LX4211 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. 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
December 31,
|
|
Year
Ended
December 31,
|
|
(In thousands, except per share
data)
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Collaborative
research
|
|
$ 320
|
|
$ 754
|
|
$ 1,632
|
|
$ 4,191
|
|
Subscription and license
fees
|
|
23
|
|
499
|
|
217
|
|
717
|
|
Total
revenues
|
|
343
|
|
1,253
|
|
1,849
|
|
4,908
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development,
including stock-based compensation
of $769, $804,
$3,249 and $3,170, respectively
|
|
28,107
|
|
18,252
|
|
91,828
|
|
78,520
|
|
Increase in fair value of
Symphony Icon, Inc. purchase liability
|
|
1,568
|
|
1,565
|
|
6,766
|
|
2,710
|
|
General and
administrative, including stock-based compensation
of $584, $716,
$2,458 and $2,308, respectively
|
|
4,010
|
|
3,861
|
|
17,350
|
|
19,396
|
|
Total operating
expenses
|
|
33,685
|
|
23,678
|
|
115,944
|
|
100,626
|
|
Loss from operations
|
|
(33,342)
|
|
(22,425)
|
|
(114,095)
|
|
(95,718)
|
|
Gain on investments,
net
|
|
-
|
|
-
|
|
-
|
|
141
|
|
Interest income
|
|
40
|
|
51
|
|
255
|
|
519
|
|
Interest expense
|
|
(551)
|
|
(626)
|
|
(2,528)
|
|
(2,719)
|
|
Other income (expense),
net
|
|
8
|
|
1
|
|
153
|
|
(4,024)
|
|
Consolidated loss before income
taxes
|
|
(33,845)
|
|
(22,999)
|
|
(116,215)
|
|
(101,801)
|
|
Income tax benefit
|
|
-
|
|
-
|
|
-
|
|
26
|
|
Consolidated net loss
|
|
$ (33,845)
|
|
$ (22,999)
|
|
$ (116,215)
|
|
$ (101,775)
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss per common
share, basic and diluted
|
|
$ (0.10)
|
|
$ (0.07)
|
|
$ (0.34)
|
|
$ (0.34)
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing
consolidated net loss per common share, basic and
diluted
|
|
350,069
|
|
337,407
|
|
340,761
|
|
302,844
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data
|
As of
December 31,
|
|
As of
December 31,
|
|
(In
thousands)
|
2011
|
|
2010
|
|
|
(unaudited)
|
|
|
|
Cash and investments
|
$ 281,692
|
|
$ 211,111
|
|
Property and equipment,
net
|
46,417
|
|
53,427
|
|
Goodwill
|
44,543
|
|
44,543
|
|
Other intangible
assets
|
53,557
|
|
53,557
|
|
Total assets
|
430,512
|
|
366,884
|
|
Deferred revenue
|
14,331
|
|
14,426
|
|
Current and long-term
debt
|
24,894
|
|
28,483
|
|
Other long-term
liabilities
|
55,146
|
|
48,783
|
|
Accumulated deficit
|
(789,621)
|
|
(673,406)
|
|
Total stockholders'
equity
|
297,568
|
|
247,024
|
|
|
|
|
|
|
|
SOURCE Lexicon Pharmaceuticals, Inc.