THE WOODLANDS, Texas,
May 10 /PRNewswire-FirstCall/ --
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 ended
March 31, 2010.
"Achieving the remarkable results from our Phase 2a trial of
LX4211 in patients with type 2 diabetes was the defining event of
the first quarter," said Dr. Arthur T. Sands, president and chief
executive officer of Lexicon. "This is the second of our four
mid-stage drug development programs to deliver positive
proof-of-concept Phase 2a results. In addition, the
completion of our recent stock offering has placed us in a strong
financial position to execute on our clinical development and
business strategies."
Key Progress in Clinical Pipeline
- Diabetes: Top-line Phase 2a clinical data from a
four-week study of Lexicon's dual sodium-glucose cotransporter 2
(SGLT2) and SGLT1 inhibitor, LX4211, in patients with type 2
diabetes demonstrated significant and rapid improvements in
multiple parameters, including improved glycemic control and
reduced HbA1c. Also noted in this study were trends toward reduced
weight, blood pressure, and triglyceride levels.
- Irritable Bowel Syndrome: Lexicon recently
presented additional findings demonstrating that measures of
5-HIAA, a biomarker of serotonin synthesis, could distinguish
between patients with irritable bowel syndrome (IBS) who responded
to LX1031 in its Phase 2a clinical trial versus those that did not.
LX1031 is an inhibitor of tryptophan hydroxylase that acts locally
in the gastrointestinal tract to reduce serotonin synthesis.
Top-line data from the trial demonstrated that the high dose
of LX1031 produced statistically-significant improvements in a
global assessment of relief of IBS pain and discomfort and in stool
consistency as compared to placebo — clinical benefits that
corresponded with a reduction in serotonin synthesis. The
results from additional analyses were presented at the Digestive
Disease Week Convention in New
Orleans.
- Rheumatoid Arthritis: Lexicon expanded its Phase 2a
clinical trial of its drug candidate for rheumatoid arthritis,
LX2931, an inhibitor of sphingosine-1-phosphate (S1P) lyase.
The study is being conducted at multiple centers in
the United States and Eastern Europe and is expected to enroll
approximately 200 patients. Top-line data are expected to be
available around the end of the year.
- Carcinoid Syndrome: Lexicon initiated an
open-label, Phase 2a trial in Europe of its drug candidate for carcinoid
syndrome, LX1032, an inhibitor of tryptophan hydroxylase that
reduces peripheral serotonin production without affecting brain
serotonin levels. Enrollment is continuing in the separate
placebo-controlled, Phase 2a trial in the
United States. Top-line data from both trials are expected
to be available in the second half of 2010.
Financial Results and Events
In March 2010, Lexicon completed
an offering of its common stock resulting in net proceeds to
Lexicon of approximately $181.5
million.
Revenues: Lexicon's revenues for the three months
ended March 31, 2010 decreased 61
percent to $1.6 million from
$4.2 million for the corresponding
period in 2009. The decrease for the three months ended
March 31, 2010 was primarily
attributable to reduced revenues under Lexicon's alliance
agreements with N.V. Organon and Bristol-Myers Squibb Company.
Research and Development Expenses: Research and
development expenses for the three months ended March 31, 2010 decreased eight percent to
$21.1 million from $22.9 million for the corresponding period in
2009. The decrease was primarily attributable to lower salary
and benefit costs, partially offset by higher external clinical
research and development costs.
General and Administrative Expenses: General and
administrative expenses for the three months ended March 31, 2010 increased 13 percent to
$5.5 million from $4.9 million for the corresponding period in
2009. The increase was primarily attributable to higher
patent-related legal costs.
Net Loss Attributable to Lexicon Pharmaceuticals, Inc.:
Net loss for the three months ended March 31, 2010 was $26.1
million, or $0.13 per share,
compared to a net loss of $21.6
million, or $0.16 per share,
in the corresponding period in 2009. For the three months
ended March 31, 2010, net loss
included non-cash, stock-based compensation expense of $1.3 million, compared to $1.4 million in the corresponding period in 2009.
Cash and Investments: As of March 31, 2010, Lexicon had $278.7 million in cash and investments net of its
obligations under the credit line secured by its auction rate
securities, as compared to $125.1
million as of December 31,
2009. Lexicon's cash and investments at December 31, 2009 included $5.4 million held by Symphony Icon, Inc. As
a result of Lexicon's adoption as of January
1, 2010 of a new accounting pronouncement regarding variable
interest entities, the results of Symphony Icon are no longer
consolidated in Lexicon's financial statements after December 31, 2009. Accordingly, Lexicon's
cash and investments at March 31,
2010 do not include the $4.4
million in cash and investments held by Symphony Icon at
March 31, 2010.
Lexicon Conference Call:
Lexicon management will hold a conference call to discuss its
clinical development progress and financial results for the first
quarter of 2010 at 11:00 a.m. Eastern
Time on May 10, 2010.
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 71087289. Investors can access www.lexpharma.com
to listen to a live webcast of the call. The webcast will be
archived and available for review through May 17, 2010.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering
and developing breakthrough treatments for human disease.
Lexicon currently has four drug candidates 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, LX2931, and LX4211 and the potential therapeutic
and commercial potential of LX1031, LX1032, LX2931, and LX4211.
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, 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, 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 "Factors Affecting Forward-Looking Statements" and "Risk
Factors" in Lexicon's annual report on Form 10-K for the year ended
December 31, 2009, 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)
|
|
2010
|
|
2009
|
|
|
|
(unaudited)
|
|
Revenues:
|
|
|
|
|
|
Collaborative
research
|
|
$
1,641
|
|
$
3,605
|
|
Subscription and
license fees
|
|
—
|
|
563
|
|
Total
revenues
|
|
1,641
|
|
4,168
|
|
Operating expenses:
|
|
|
|
|
|
Research and development, including
stock-based compensation of $806 and $829, respectively
|
|
21,088
|
|
22,864
|
|
General and administrative, including
stock-based compensation of $499 and $613, respectively
|
|
5,519
|
|
4,874
|
|
Total operating
expenses
|
|
26,607
|
|
27,738
|
|
Loss from operations
|
|
(24,966)
|
|
(23,570)
|
|
Gain on investments, net
|
|
88
|
|
517
|
|
Interest income
|
|
217
|
|
327
|
|
Interest expense
|
|
(727)
|
|
(666)
|
|
Other expense, net
|
|
(682)
|
|
(945)
|
|
Consolidated net loss
|
|
(26,070)
|
|
(24,337)
|
|
Less: Net loss attributable to
noncontrolling interest in Symphony Icon, Inc.
|
|
—
|
|
2,777
|
|
Net loss attributable to Lexicon
Pharmaceuticals, Inc.
|
|
$
(26,070)
|
|
$
(21,560)
|
|
|
|
|
|
|
|
Net
loss attributable to Lexicon Pharmaceuticals, Inc. per common
share, basic and diluted
|
|
$
(0.13)
|
|
$
(0.16)
|
|
|
|
|
|
|
|
Shares
used in computing net loss attributable to Lexicon Pharmaceuticals,
Inc. per common share, basic and diluted
|
|
197,239
|
|
137,075
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data
|
As of March
31,
|
|
As
of December 31,
|
|
(In
thousands)
|
2010
|
|
2009
|
|
|
(unaudited)
|
|
|
|
Cash and investments (1)
|
$
314,181
|
|
$
162,513
|
|
Obligations under line of
credit
|
(35,531)
|
|
(37,435)
|
|
Cash and investments, net of
obligations under line of credit(1)
|
278,650
|
|
125,078
|
|
|
|
|
|
|
Property and equipment, net
|
57,850
|
|
58,754
|
|
Goodwill
|
25,798
|
|
25,798
|
|
Total assets
|
409,211
|
|
257,761
|
|
Deferred revenue
|
14,788
|
|
15,154
|
|
Current and long-term debt, including
line of credit
|
64,798
|
|
66,964
|
|
Noncontrolling interest in Symphony
Icon, Inc.
|
—
|
|
(290)
|
|
Accumulated deficit
|
(597,701)
|
|
(570,175)
|
|
Total Lexicon Pharmaceuticals, Inc.
stockholders' equity
|
318,905
|
|
163,787
|
|
|
|
|
|
|
(1) Cash and investments
at December 31, 2009 included $5.4 million held by Symphony Icon,
Inc. As a result of Lexicon's adoption as of January 1, 2010
of a new accounting pronouncement regarding variable interest
entities, the results of Symphony Icon are no longer consolidated
in Lexicon's financial statements after December 31, 2009.
Accordingly, cash and investments at March 31, 2010 do not
include the $4.4 million in cash and investments held by Symphony
Icon at March 31, 2010.
|
|
|
|
|
|
|
|
SOURCE Lexicon Pharmaceuticals, Inc.