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
- LX4211: 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.
- Telotristat 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.
- LX1033: 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.
- Other 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 Operations
Data
|
Three
Months Ended
December 31,
|
|
Year
Ended
December 31,
|
(In
thousands, except per share data)
|
2012
|
|
2011
|
|
2012
|
|
2011
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
Collaborative research
|
$
218
|
|
$
320
|
|
$
783
|
|
$
1,632
|
Subscription and license fees
|
-
|
|
23
|
|
306
|
|
217
|
Total revenues
|
218
|
|
343
|
|
1,089
|
|
1,849
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and development, including stock-based
compensation
of $798, $769, $3,673 and $3,249,
respectively
|
20,990
|
|
28,107
|
|
82,574
|
|
91,828
|
Increase (decrease) in fair value of Symphony Icon,
Inc
purchase liability
|
(200)
|
|
1,568
|
|
9,887
|
|
6,766
|
General and administrative, including stock-based
compensation
of $792, $584, $2,822 and $2,458,
respectively
|
3,920
|
|
4,010
|
|
17,043
|
|
17,350
|
Total operating expenses
|
24,710
|
|
33,685
|
|
109,504
|
|
115,944
|
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
diluted
|
$
(0.05)
|
|
$
(0.10)
|
|
$
(0.23)
|
|
$
(0.34)
|
|
|
|
|
|
|
|
|
Shares
used in computing consolidated net loss per common share, basic and
diluted
|
507,619
|
|
350,069
|
|
489,707
|
|
340,761
|
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.