THE WOODLANDS, Texas,
July 30, 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 and six months ended
June 30, 2013.
"We have continued to advance multiple programs in our clinical
pipeline, most notably completing enrollment of Phase 2 studies of
telotristat etiprate in ulcerative colitis and LX1033 in
diarrhea-predominant irritable bowel syndrome. We look forward to
obtaining top-line results from these studies around the end of the
third quarter and in the fourth quarter of 2013, respectively,"
said Dr. Arthur T. Sands, president and chief executive officer of
Lexicon. "In addition, we obtained initial safety data from
the pioneer portion of our Phase 2 trial of LX4211 in Type 1
diabetes and subsequently advanced the study into its expansion
phase."
Progress in Clinical Pipeline
- LX4211: LX4211 is a dual inhibitor of sodium-glucose
transporters 1 and 2 (SGLT1 and SGLT2). SGLT1 is primarily
responsible for glucose absorption in the gastrointestinal tract
and SGLT2 is responsible for most of the glucose reabsorption
performed by the kidney. At the 73rd Scientific
Sessions of the American Diabetes Association, Lexicon presented a
sub-analysis of blood pressure effects observed in the 12-week
dose-ranging Phase 2b study of LX4211 in type 2 diabetes.
Notably, patients with high baseline systolic blood pressure
(≥130 mmHg) dosed with LX4211 experienced an average of 14 mmHg
reduction in systolic blood pressure when compared to placebo
(p=0.002). In contrast, patients with normal systolic blood
pressure at baseline (<130 mmHg) experienced an average of only
1 mmHg reduction (p=0.6). Lexicon also completed the pioneer
portion of a Phase 2 clinical trial of LX4211 in type 1 diabetes,
with LX4211 showing a favorable safety profile when given in
combination with insulin. Lexicon has initiated enrollment of
patients in the placebo-controlled, expansion portion of the type 1
diabetes trial and is proceeding with preparations for the
initiation of Phase 3 clinical trials of LX4211 in type 2
diabetes.
- Telotristat etiprate (LX1032): Telotristat etiprate is an
inhibitor of tryptophan hydroxylase that reduces peripheral
serotonin production without affecting brain serotonin levels.
Lexicon has completed enrollment of patients in a Phase 2 clinical
trial of telotristat etiprate in ulcerative colitis and continues
to enroll patients in a pivotal Phase 3 clinical trial of
telotristat etiprate in carcinoid syndrome.
- LX1033: LX1033 is an inhibitor of tryptophan hydroxylase that
acts locally in the gastrointestinal tract to reduce serotonin
production without impacting brain serotonin levels. Lexicon is
completing enrollment of patients in a Phase 2 clinical trial of
LX1033 in diarrhea-predominant IBS (IBS-d).
- LX2761: At the 73rd Scientific Sessions of the
American Diabetes Association, Lexicon presented data on its
newest clinical candidate for diabetes. LX2761 acts locally
in the gastrointestinal tract to reduce glucose absorption by
inhibiting SGLT1 without any significant inhibition of SGLT2 in the
kidney. LX2761 was shown to improve glycemic control in two
mouse models of diabetes, as measured by reductions in hemoglobin
A1c and oral glucose tolerance tests.
Financial Results
Revenues: Lexicon's revenues for the three months
ended June 30, 2013 were $0.2 million, consistent with the corresponding
period in 2012. For the six months ended June 30, 2013, revenues increased to $0.6 million from $0.5
million for the corresponding period in 2012.
Research and Development Expenses: Research and
development expenses for the three months ended June 30, 2013 increased 22 percent to
$23.7 million from $19.4 million for the corresponding period in
2012. The increase was primarily attributable to increases in
external clinical and preclinical research and development and
personnel costs, partially offset by decreases in facility
costs. For the six months ended June
30, 2013, research and development expenses increased four
percent to $44.0 million from
$42.4 million for the
corresponding period in 2012.
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 $0.5 million and $2.2 million for the three months ended
June 30, 2013 and 2012, respectively,
and was $1.7 million and $4.2 million for the six months ended
June 30, 2013 and 2012,
respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended June 30, 2013 increased 12 percent to
$4.7 million from $4.2 million for the corresponding period in
2012. The increase was primarily attributable to increases in
personnel costs and legal and patent fees. For the six months
ended June 30, 2013, general and
administrative expenses increased three percent to $9.0 million from $8.7
million for the corresponding period in 2012.
Consolidated Net Loss: Net loss for the three
months ended June 30, 2013 was
$29.1 million, or $0.06 per share, compared to a net loss of
$25.9 million, or $0.05 per share, in the corresponding period in
2012. Net loss for the six months ended June 30, 2013 was $55.1
million, or $0.11 per share,
compared to a net loss of $55.8
million, or $0.12 per share,
for the corresponding period in 2012. For the three and six
months ended June 30, 2013, net loss
included non-cash, stock-based compensation expense of $1.9 million and $4.0
million, respectively. For the three and six months ended
June 30, 2012, net loss included
non-cash, stock-based compensation expense of $1.6 million and $3.3
million, respectively.
Cash and Investments: As of June 30, 2013, Lexicon had $175.4 million in cash and investments, as
compared to $197.2 million as of
March 31, 2013 and $223.2 million as of December 31, 2012.
Lexicon Conference Call
Lexicon management will hold a conference call to discuss its
clinical development progress and financial results for the second
quarter of 2013 at 11:00 a.m. Eastern
Time on July 30, 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 22881223.
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 August 30,
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 and
LX2761, 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 and LX2761. 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 and LX2761 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,
2012, 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
June
30,
|
|
Six Months
Ended
June
30,
|
(In thousands,
except per share data)
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative research
|
|
$
211
|
|
$
199
|
|
$
495
|
|
$
351
|
Subscription and license fees
|
|
3
|
|
-
|
|
79
|
|
148
|
Total revenues
|
|
214
|
|
199
|
|
574
|
|
499
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, including stock-based compensation of $1,022, $915, $2,352 and $1,952,
respectively
|
|
23,692
|
|
19,355
|
|
44,019
|
|
42,392
|
Increase in fair
value of Symphony Icon, Inc. purchase
liability
|
|
477
|
|
2,162
|
|
1,741
|
|
4,243
|
General and
administrative, including stock-based compensation
of $847, $680, $1,626 and $1,361,
respectively
|
|
4,669
|
|
4,162
|
|
8,993
|
|
8,727
|
Total operating expenses
|
|
28,838
|
|
25,679
|
|
54,753
|
|
55,362
|
Loss from
operations
|
|
(28,624)
|
|
(25,480)
|
|
(54,179)
|
|
(54,863)
|
Interest
income
|
|
44
|
|
58
|
|
97
|
|
114
|
Interest
expense
|
|
(496)
|
|
(530)
|
|
(1,002)
|
|
(1,067)
|
Other income
(expense), net
|
|
(4)
|
|
21
|
|
30
|
|
17
|
Consolidated net
loss
|
|
$
(29,080)
|
|
$
(25,931)
|
|
$
(55,054)
|
|
$
(55,799)
|
|
|
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$
(0.06)
|
|
$
(0.05)
|
|
$
(0.11)
|
|
$
(0.12)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss attributable to Lexicon Pharmaceuticals,
Inc. per common share, basic and diluted
|
|
513,083
|
|
480,634
|
|
512,757
|
|
480,479
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data
|
As of June
30,
|
|
As of December
31,
|
(In
thousands)
|
2013
|
|
2012
|
|
(unaudited)
|
|
|
Cash and
investments
|
$
175,378
|
|
$
223,208
|
Property and
equipment, net
|
42,152
|
|
42,634
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,557
|
|
53,557
|
Total
assets
|
323,393
|
|
371,778
|
Deferred
revenue
|
14,028
|
|
14,038
|
Current and long-term
debt
|
22,678
|
|
23,451
|
Other long-term
liabilities
|
35,256
|
|
32,283
|
Accumulated
deficit
|
(954,886)
|
|
(899,832)
|
Total stockholders'
equity
|
215,084
|
|
266,678
|
|
SOURCE Lexicon Pharmaceuticals, Inc.