THE WOODLANDS, Texas,
May 3, 2012 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company
focused on discovering breakthrough treatments for human disease,
today updated its drug development progress and reported financial
results for the three months ended March 31,
2012.
"We continue to make excellent progress in our
clinical-development stage programs and preclinical pipeline.
Our Phase 2b study of LX4211 in patients with type 2 diabetes has
completed enrollment and is on track to obtain top-line data by
mid-year," said Dr. Arthur T. Sands, president and chief executive
officer of Lexicon. "In addition, in the first quarter of
2012, we initiated Phase 2 studies of LX1033 in patients with
diarrhea-predominant irritable bowel syndrome (IBS-d) and of LX1032
in patients with ulcerative colitis, and we launched a Phase 1-2
proof-of-concept study of LX7101 in glaucoma patients. We
look forward to obtaining data from these and our other ongoing
studies and continuing the advancement of our clinical
pipeline."
Key Progress in Clinical Pipeline
- Lexicon completed enrollment in the ongoing 12-week Phase 2b
study of LX4211, a dual inhibitor of sodium-glucose cotransporters
1 and 2, in patients with type 2 diabetes. Top-line data from
this study are anticipated by mid-year.
- Lexicon is proceeding with preparations for Phase 3
registrational trials of telotristat etiprate (LX1032), an
inhibitor of tryptophan hydroxylase that reduces peripheral
serotonin production without affecting brain serotonin levels, in
patients with carcinoid syndrome. Lexicon also initiated a
Phase 2 proof-of-concept trial of telotristat etiprate in patients
with ulcerative colitis.
- Lexicon launched a Phase 2 trial of LX1033, a serotonin
synthesis inhibitor, in patients with IBS‑d.
- Lexicon recently completed enrollment in a dose-ranging study
to explore higher doses of LX2931, an inhibitor of
sphingosine-1-phosphate lyase, in patients with rheumatoid
arthritis.
- Lexicon initiated a Phase 1-2 proof-of-concept study of LX7101
in glaucoma patients. LX7101 targets LIM domain kinase 2
(LIMK2), a novel mechanism of action that Lexicon research
identified in preclinical models as reducing intraocular pressure
by allowing more fluid to flow through the trabecular meshwork of
the anterior chamber of the eye.
Revenues: Lexicon's revenues for the three months
ended March 31, 2012 decreased 50
percent to $0.3 million from
$0.6 million for the corresponding
period in 2011. The decrease for the three months ended
March 31, 2012 was primarily
attributable to reduced revenues from the United States Army
Medical Research Acquisition Activity and Lexicon's alliance with
Taconic Farms.
Research and Development Expenses: Research and
development expenses for the three months ended March 31, 2012 decreased four percent to
$23.0 million from $23.9 million for the corresponding period in
2011. The decrease was primarily attributable to decreases in
facility and personnel costs, partially offset by an increase in
external manufacturing, clinical research and development
costs.
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 $2.1 million and $1.1 million for the three months ended
March 31, 2012 and 2011,
respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended March 31, 2012 decreased four percent to
$4.6 million from $4.8 million for the corresponding period in
2011. The decrease was primarily attributable to decreases in
personnel and facility costs.
Consolidated Net Loss: Net loss for the three
months ended March 31, 2012 was
$29.9 million, or $0.06 per share, compared to a net loss of
$29.6 million, or $0.09 per share, in the corresponding period in
2011. For the three months ended March
31, 2012, net loss included non-cash, stock-based
compensation expense of $1.7 million,
compared to $1.5 million in the
corresponding period in 2011.
Cash and Investments: As of March 31, 2012, Lexicon had $253.7 million in cash and investments, as
compared to $281.7 million as of
December 31, 2011.
Lexicon Conference Call:
Lexicon management will hold a conference call and webcast at
11:00 a.m. Eastern Time on
May 3, 2012 to discuss financial
results for the first quarter of 2012 and the current status of its
clinical programs. 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 73722762. 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 at www.lexpharma.com through May 31, 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 telotristat etiprate (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 telotristat etiprate
(LX1032), LX1033, LX2931, LX4211, and LX7101. 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 telotristat etiprate (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, 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
March
31,
|
(In
thousands, except per share data)
|
|
2012
|
|
2011
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
Collaborative
research................................................................
|
|
$
152
|
|
$
516
|
Subscription and license
fees......................................................
|
|
148
|
|
80
|
Total
revenues......................................................................
|
|
300
|
|
596
|
Operating
expenses:
|
|
|
|
|
Research and development, including stock-based
compensation
of $1,037 and $839,
respectively...........................................
|
|
23,037
|
|
23,921
|
Increase in fair value of Symphony Icon, Inc.
purchase liability
|
|
2,081
|
|
1,058
|
General and administrative, including stock-based
compensation
of $681 and $633,
respectively..............................................
|
|
4,565
|
|
4,753
|
Total operating
expenses......................................................
|
|
29,683
|
|
29,732
|
Loss from
operations..........................................................................
|
|
(29,383)
|
|
(29,136)
|
Interest
income...................................................................................
|
|
56
|
|
87
|
Interest
expense..................................................................................
|
|
(537)
|
|
(607)
|
Other
income (expense),
net...............................................................
|
|
(4)
|
|
27
|
Consolidated net
loss..........................................................................
|
|
$
(29,868)
|
|
$
(29,629)
|
|
|
|
|
|
Consolidated net loss per common share, basic and
diluted...............
|
|
$
(0.06)
|
|
$
(0.09)
|
|
|
|
|
|
Shares
used in computing consolidated net loss per common share,
basic
and
diluted..........................................................................................
|
|
480,324
|
|
337,527
|
Consolidated Balance Sheet Data
|
As of
March 31,
|
|
As of
December 31,
|
(In
thousands)
|
2012
|
|
2011
|
|
(unaudited)
|
|
|
Cash and
investments
..........................................................................................................................
|
$
253,656
|
|
$
281,692
|
Property
and equipment,
net.................................................................................................................
|
45,526
|
|
46,417
|
Goodwill...............................................................................................................................................
|
44,543
|
|
44,543
|
Other
intangible
assets..........................................................................................................................
|
53,557
|
|
53,557
|
Total
assets...........................................................................................................................................
|
402,792
|
|
430,512
|
Deferred
revenue..................................................................................................................................
|
14,331
|
|
14,331
|
Current
and long-term
debt...................................................................................................................
|
24,541
|
|
24,894
|
Other
long-term
liabilities.....................................................................................................................
|
57,170
|
|
55,146
|
Accumulated
deficit..............................................................................................................................
|
(819,489)
|
|
(789,621)
|
Total
stockholders' equity
....................................................................................................................
|
268,971
|
|
297,568
|
|
SOURCE Lexicon Pharmaceuticals, Inc.