THE WOODLANDS, Texas,
Feb. 28, 2014 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a
biopharmaceutical company focused on 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, 2013.
"We made important progress in our late-stage drug development
programs in 2013, completing multiple studies of LX4211 for
diabetes and increasing enrollment in our pivotal Phase 3 trial for
telotristat etiprate for carcinoid syndrome," said Dr. Arthur T.
Sands, president and chief executive officer of Lexicon. "In 2014,
we expect to focus our resources on advancing those programs
through clinical development and preparing for the transition to
commercialization."
Key Developments in 2013
- LX4211: Lexicon announced positive top-line results from
a proof-of-concept study of LX4211, a dual inhibitor of
sodium-glucose transporters 1 and 2, in patients with type 2
diabetes and moderate to severe renal impairment. LX4211
achieved the primary endpoint of reducing post-prandial glucose and
was well tolerated, with treatment emergent adverse events being
characterized as mild or moderate in severity and evenly
distributed between LX4211 and placebo. Lexicon also
completed the pioneer portion of a Phase 2 clinical trial of LX4211
in patients with type 1 diabetes, in which LX4211 was given in
combination with insulin. Lexicon completed enrollment of
patients in the placebo-controlled, expansion portion of the trial
and expects to report top-line results near the end of the first
quarter of 2014.
- Telotristat etiprate (LX1032): Lexicon made significant
progress in the enrollment of carcinoid syndrome patients in a
pivotal Phase 3 clinical trial of telotristat etiprate, an
inhibitor of tryptophan hydroxylase (TPH) that reduces peripheral
serotonin production without affecting brain serotonin
levels. Lexicon also initiated a companion study of
telotristat etiprate in the same indication.
- LX1033: Lexicon completed a Phase 2 clinical trial of
LX1033, an inhibitor of TPH that acts locally in the
gastrointestinal tract to reduce serotonin production without
impacting brain serotonin levels. Top-line data from the
study, which evaluated the safety and tolerability of LX1033 and
its effect on symptoms associated with irritable bowel syndrome,
showed that all treatment groups, including placebo, showed
significant improvements in stool consistency over time.
However, such improvements in patients treated with LX1033 were not
statistically significant relative to those treated with placebo.
In January 2014, Lexicon announced
plans to focus its resources on its late-stage drug development
programs, principally LX4211 and telotristat etiprate, in
preparation for the transition to commercialization. The
change in focus involves personnel reductions, primarily in
research, discovery and support positions, during the first and
second quarter of 2014. With the change in focus, Dr. Sands
indicated his intention to develop a succession plan with the board
of directors to identify a new chief executive officer for the next
phase of Lexicon's growth. The board of directors has
initiated a search for a new chief executive officer and has
designated a subcommittee of the board of directors to assist in
those efforts. It is planned that Dr. Sands will continue as
chief executive officer until that process is complete.
Financial Results
Revenues: Lexicon's revenues for the three months
ended December 31, 2013 increased 547
percent to $1.4 million from
$0.2 million for the corresponding
period in 2012, primarily due to revenues recognized from a
collaboration with a non-profit institute supporting the Phase 2
development of LX4211 in type 1 diabetes. For the year ended
December 31, 2013, revenues increased
104 percent to $2.2 million from
$1.1 million for the corresponding
period in 2012.
Research and Development Expenses: Research and
development expenses for the three months ended December 31, 2013 decreased three percent to
$20.3 million from $21.0 million for the corresponding period
in 2012. For the year ended December
31, 2013, research and development expenses increased nine
percent to $89.7 million from
$82.6 million for the corresponding
period in 2012.
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,
2013, the fair value of the Symphony Icon purchase liability
decreased by $5.3 million as compared
to a decrease of $0.2 million in the
corresponding period in 2012. The decrease was primarily
attributable to a reduction in the liability associated with
Lexicon's LX1033 development program in diarrhea-predominant
irritable bowel syndrome. For the year ended December 31, 2013, the fair value of the Symphony
Icon purchase liability decreased by $2.2
million as compared to an increase of $9.9 million in the corresponding period in
2012.
General and Administrative Expenses: General and
administrative expenses for the three months ended December 31, 2013 decreased 13 percent to
$3.4 million from $3.9 million for the corresponding period in
2012. For the year ended December 31,
2013, general and administrative expenses increased slightly
to $17.1 million from $17.0 million for the corresponding period in
2012.
Consolidated Net Loss: Net loss for the three
months ended December 31, 2013 was
$17.4 million, or $0.03 per share, compared to a net loss of
$24.9 million, or $0.05 per share, in the corresponding period in
2012. Net loss for the year ended December
31, 2013 was $104.1 million,
or $0.20 per share, compared to a net
loss of $110.2 million, or
$0.23 per share, for the
corresponding period in 2012. For the three months and year ended
December 31, 2013, net loss included
non-cash, stock-based compensation expense of $1.7 million and $7.4
million, respectively. 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.
Cash and Investments: As of December 31, 2013, Lexicon had $129.1 million in cash and investments, as
compared to cash and investments of $151.2
million as of September 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 2013 and financial guidance for 2014 at
11:00 a.m. Eastern Time on
February 28, 2014.
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 30511451. 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 28, 2014.
About Lexicon
Lexicon is a biopharmaceutical company
focused on developing breakthrough treatments for human
disease. Lexicon has clinical-stage drug programs for
diabetes, 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. 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, 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
December
31,
|
|
Year
Ended
December
31,
|
(In thousands, except
per share data)
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative research
|
|
$
1,376
|
|
$
218
|
|
$
2,109
|
|
$
783
|
Subscription and license fees
|
|
34
|
|
-
|
|
113
|
|
306
|
Total revenues
|
|
1,410
|
|
218
|
|
2,222
|
|
1,089
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, including stock-based compensation
of $997, $798, $4,376
and $3,673, respectively
|
|
20,263
|
|
20,990
|
|
89,682
|
|
82,574
|
Increase (decrease)
in fair value of Symphony Icon, Inc
purchase
liability
|
|
(5,289)
|
|
(200)
|
|
(2,210)
|
|
9,887
|
General and
administrative, including stock-based compensation
of $696, $792, $3,045
and $2,822, respectively
|
|
3,412
|
|
3,920
|
|
17,121
|
|
17,043
|
Total operating expenses
|
|
18,386
|
|
24,710
|
|
104,593
|
|
109,504
|
Loss from
operations
|
|
(16,976)
|
|
(24,492)
|
|
(102,371)
|
|
(108,415)
|
Interest
income
|
|
21
|
|
55
|
|
157
|
|
213
|
Interest
expense
|
|
(477)
|
|
(520)
|
|
(1,971)
|
|
(2,114)
|
Other income,
net
|
|
18
|
|
84
|
|
59
|
|
105
|
Consolidated net
loss
|
|
$
(17,414)
|
|
$
(24,873)
|
|
$
(104,126)
|
|
$
(110,211)
|
|
|
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$
(0.03)
|
|
$
(0.05)
|
|
$
(0.20)
|
|
$
(0.23)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing consolidated net loss per common share, basic and
diluted
|
|
513,523
|
|
507,619
|
|
513,117
|
|
489,707
|
Consolidated
Balance Sheet Data
|
As of December
31,
|
|
As of December
31,
|
(In
thousands)
|
2013
|
|
2012
|
|
(unaudited)
|
|
|
Cash and
investments
|
$
129,128
|
|
$
223,208
|
Property and
equipment, net
|
41,362
|
|
42,634
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,557
|
|
53,557
|
Total
assets
|
274,160
|
|
371,778
|
Deferred
revenue
|
13,600
|
|
14,038
|
Current and long-term
debt
|
21,877
|
|
23,451
|
Other long-term
liabilities
|
32,386
|
|
32,283
|
Accumulated
deficit
|
(1,003,959)
|
|
(899,832)
|
Total stockholders'
equity
|
170,163
|
|
266,678
|
SOURCE Lexicon Pharmaceuticals, Inc.