THE WOODLANDS, Texas,
Nov. 12, 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 nine months ended September 30,
2013.
"We have continued to make significant progress in the
advancement of our clinical pipeline, highlighted by our
announcement of positive top-line results from a phase 2 study of
LX4211 in patients with type 2 diabetes and moderate to severe
renal impairment," said Dr. Arthur T. Sands, president and chief
executive officer of Lexicon.
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. Lexicon announced positive top-line
results from a phase 2 study of LX4211 in patients with type 2
diabetes and moderate to severe renal impairment, and is proceeding
with preparations for the initiation of Phase 3 clinical trials of
LX4211 in type 2 diabetes. Lexicon also continues to enroll
patients in a phase 2 trial of LX4211 in type 1 diabetes.
- Telotristat etiprate (LX1032): Telotristat etiprate is an
inhibitor of tryptophan hydroxylase that reduces peripheral
serotonin production without affecting brain serotonin levels.
Lexicon announced top-line results from a pilot study of
telotristat etiprate in patients with mild to moderate ulcerative
colitis, and plans to maintain focus on its ongoing Phase 3 program
for telotristat etiprate in carcinoid syndrome. Lexicon 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
completed enrollment of patients in a Phase 2 clinical trial of
LX1033 in diarrhea-predominant IBS, with top-line results expected
to be released in November 2013.
Financial Results
Revenues: Lexicon's revenues for the three months
ended September 30, 2013 decreased 36
percent to $0.2 million from
$0.4 million for the corresponding
period in 2012, primarily due to decreases in technology license
fees. For the nine months ended September 30, 2013, revenues decreased seven
percent to $0.8 million from
$0.9 million for the corresponding
period in 2012.
Research and Development Expenses: Research and
development expenses for the three months ended September 30, 2013 increased 32 percent to
$25.4 million from $19.2 million for the corresponding period in
2012. The increase was primarily attributable to increases in
external clinical and preclinical research and development costs
resulting from the advancement of our clinical pipeline, partially
offset by decreases in facility costs. For the nine months
ended September 30, 2013, research
and development expenses increased 13 percent to $69.4 million from $61.6
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 $1.3 million and $5.8 million for the three months ended
September 30, 2013 and 2012,
respectively, and was $3.1 million
and $10.1 million for the nine months
ended September 30, 2013 and 2012,
respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended September 30, 2013 increased seven percent to
$4.7 million from $4.4 million for the corresponding period in
2012. The increase was primarily attributable to increases in
market research, consulting and personnel costs. For the nine
months ended September 30, 2013,
general and administrative expenses increased four percent to
$13.7 million from $13.1 million for the corresponding period in
2012.
Consolidated Net Loss: Net loss for the three
months ended September 30, 2013 was
$31.7 million, or $0.06 per share, compared to a net loss of
$29.5 million, or $0.06 per share, in the corresponding period in
2012. Net loss for the nine months ended September 30, 2013 was $86.7 million, or $0.17 per share, compared to a net loss of
$85.3 million, or $0.18 per share, for the corresponding period in
2012. For the three and nine months ended September 30, 2013, net loss included non-cash,
stock-based compensation expense of $1.8
million and $5.7 million,
respectively. For the three and nine months ended September 30, 2012, net loss included non-cash,
stock-based compensation expense of $1.6
million and $4.9 million,
respectively.
Cash and Investments: As of September 30, 2013, Lexicon had $151.2 million in cash and investments, as
compared to $175.4 million as of
June 30, 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 third
quarter of 2013 at 11:00 a.m. Eastern
Time on November 12, 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 97923296.
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 December
12, 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) and LX1033,
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)
and LX1033. 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) and LX1033 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
September
30,
|
|
Nine Months
Ended
September
30,
|
(In thousands,
except per share data)
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative research
|
|
$
238
|
|
$
214
|
|
$
733
|
|
$
565
|
Subscription and license fees
|
|
-
|
|
158
|
|
79
|
|
306
|
Total revenues
|
|
238
|
|
372
|
|
812
|
|
871
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, including stock-based compensation
of $1,027, $923,
$3,379 and $2,875, respectively
|
|
25,400
|
|
19,192
|
|
69,419
|
|
61,584
|
Increase in fair
value of Symphony Icon, Inc. purchase liability
|
|
1,338
|
|
5,844
|
|
3,079
|
|
10,087
|
General and
administrative, including stock-based compensation
of $723, $669, $2,349
and $2,030, respectively
|
|
4,716
|
|
4,396
|
|
13,709
|
|
13,123
|
Total operating expenses
|
|
31,454
|
|
29,432
|
|
86,207
|
|
84,794
|
Loss from
operations
|
|
(31,216)
|
|
(29,060)
|
|
(85,395)
|
|
(83,923)
|
Interest
income
|
|
39
|
|
44
|
|
136
|
|
158
|
Interest
expense
|
|
(492)
|
|
(527)
|
|
(1,494)
|
|
(1,594)
|
Other income,
net
|
|
11
|
|
4
|
|
41
|
|
21
|
Consolidated net
loss
|
|
$
(31,658)
|
|
$
(29,539)
|
|
$
(86,712)
|
|
$
(85,338)
|
|
|
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$
(0.06)
|
|
$
(0.06)
|
|
$
(0.17)
|
|
$
(0.18)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss attributable to Lexicon Pharmaceuticals,
Inc. per common share, basic and diluted
|
|
513,419
|
|
490,049
|
|
512,980
|
|
483,693
|
Consolidated
Balance Sheet Data
|
As of September
30,
|
|
As of December
31,
|
(In
thousands)
|
2013
|
|
2012
|
|
(unaudited)
|
|
|
Cash and
investments
|
$
151,210
|
|
$
223,208
|
Property and
equipment, net
|
41,838
|
|
42,634
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,557
|
|
53,557
|
Total
assets
|
299,458
|
|
371,778
|
Deferred
revenue
|
14,090
|
|
14,038
|
Current and long-term
debt
|
22,284
|
|
23,451
|
Other long-term
liabilities
|
37,391
|
|
32,283
|
Accumulated
deficit
|
(986,544)
|
|
(899,832)
|
Total stockholders'
equity
|
185,710
|
|
266,678
|
|
SOURCE Lexicon Pharmaceuticals, Inc.