THE WOODLANDS, Texas,
Aug. 7, 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 and six
months ended June 30, 2014.
"I have spent the better part of this past month reviewing the
progress of our two lead programs, LX4211 and telotristat
etiprate," said Lonnel Coats, Lexicon's newly appointed president
and chief executive officer. "I am very encouraged by the current
status of these programs and am looking forward to unlocking the
tremendous value they hold."
Progress in Clinical Pipeline
- LX4211: Lexicon announced a collaboration with JDRF to
support a Phase 2, randomized, double-masked, placebo-controlled
clinical trial to evaluate the efficacy and safety of LX4211 in
individuals with type 1 diabetes that are younger than 30 years of
age. The study will be conducted with the primary objective
being to evaluate the safety and effectiveness of LX4211 versus
placebo as an adjunct to insulin treatment, as measured by HbA1c
reduction at 12 weeks, as well as several secondary
endpoints.
- Telotristat etiprate (LX1032): Lexicon continues to make
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.
Financial Results
Revenues: Lexicon's revenues for the three months
ended June 30, 2014 increased to
$0.7 million from $0.2 million for the corresponding period in
2013, primarily due to revenues recognized from a collaboration
with a non-profit institute supporting the Phase 2 development of
LX4211 in type 1 diabetes and increased revenues from other
functional genomics activities. For the six months ended
June 30, 2014, revenues increased 66
percent to $1.0 million from
$0.6 million for the corresponding
period in 2013.
Research and Development Expenses: Research and
development expenses for the three months ended June 30, 2014 decreased 11 percent to
$21.2 million from $23.7 million for the corresponding period in
2013, primarily due to decreases in personnel costs as a result of
the restructuring announced in January
2014 and decreases in lab supply costs as Lexicon focuses
its resources on late-stage drug development. For the six months
ended June 30, 2014, research and
development expenses increased three percent to $45.1 million from $44.0
million for the corresponding period in 2013.
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 $0.4 million and $0.5 million for the three months ended
June 30, 2014 and 2013, respectively,
and was $1.6 million and $1.7 million for the six months ended
June 30, 2014 and 2013,
respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended June 30, 2014 increased 10 percent to
$5.2 million from $4.7 million for the corresponding period in
2013, primarily due to severance costs as a result of the
restructuring announced in January 2014. For the six months
ended June 30, 2014, general and
administrative expenses increased 20 percent to $10.8 million from $9.0
million for the corresponding period in 2013.
Consolidated Net Loss: Net loss for the three
months ended June 30, 2014 was
$26.0 million, or $0.05 per share, compared to a net loss of
$29.1 million, or $0.06 per share, in the corresponding period in
2013. Net loss for the six months ended June 30, 2014 was $56.9
million, or $0.11 per share,
compared to a net loss of $55.1
million, or $0.11 per share,
for the corresponding period in 2013. For the three and six
months ended June 30, 2014, net loss
included non-cash, stock-based compensation expense of $1.8 million and $4.1
million, respectively. 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.
Cash and Investments: As of June 30, 2014, Lexicon had $79.0 million in cash and investments, as
compared to $98.4 million as of
March 31, 2014 and $129.1 million as of December 31, 2013.
Lexicon Conference Call
Lexicon management will hold a
conference call to discuss its clinical development progress and
financial results for the second quarter of 2014 at 11:00 a.m. Eastern Time on August 7, 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 82427776. 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 September 7, 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 and telotristat etiprate
(LX1032), including characterizations of the results of and
projected timing of clinical trials and the potential therapeutic
and commercial potential of LX4211 and telotristat etiprate
(LX1032). 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 meet its capital requirements, successfully conduct clinical
development of LX4211 and telotristat etiprate (LX1032) 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, 2013, 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)
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative research
|
|
$ 627
|
|
$ 211
|
|
$
799
|
|
$
495
|
Subscription and license fees
|
|
49
|
|
3
|
|
154
|
|
79
|
Total revenues
|
|
676
|
|
214
|
|
953
|
|
574
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, including stock-based compensation of $940, $1,022, $2,398 and $2,352,
respectively
|
|
21,187
|
|
23,692
|
|
45,140
|
|
44,019
|
Increase in fair value
of Symphony Icon, Inc. purchase liability
|
|
448
|
|
477
|
|
1,590
|
|
1,741
|
General and
administrative, including stock-based compensation
of $900, $847, $1,692 and $1,626,
respectively
|
|
5,152
|
|
4,669
|
|
10,806
|
|
8,993
|
Total operating expenses
|
|
26,787
|
|
28,838
|
|
57,536
|
|
54,753
|
Loss from
operations
|
|
(26,111)
|
|
(28,624)
|
|
(56,583)
|
|
(54,179)
|
Interest
income
|
|
4
|
|
44
|
|
12
|
|
97
|
Interest
expense
|
|
(455)
|
|
(496)
|
|
(912)
|
|
(1,002)
|
Other income
(expense), net
|
|
534
|
|
(4)
|
|
620
|
|
30
|
Consolidated net
loss
|
|
$ (26,028)
|
|
$ (29,080)
|
|
$ (56,863)
|
|
$ (55,054)
|
|
|
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$ (0.05)
|
|
$ (0.06)
|
|
$ (0.11)
|
|
$ (0.11)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss attributable to Lexicon Pharmaceuticals, Inc.
per common share, basic and diluted
|
|
514,623
|
|
513,083
|
|
514,291
|
|
512,757
|
|
|
|
|
Consolidated
Balance Sheet Data
|
As of June
30,
|
|
As of December
31,
|
(In
thousands)
|
2014
|
|
2013
|
|
(unaudited)
|
|
|
Cash and
investments
|
$ 79,044
|
|
$ 129,128
|
Property and
equipment, net
|
39,177
|
|
41,362
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,557
|
|
53,557
|
Total
assets
|
224,064
|
|
274,160
|
Deferred
revenue
|
13,556
|
|
13,600
|
Current and long-term
debt
|
21,038
|
|
21,877
|
Other long-term
liabilities
|
34,821
|
|
32,386
|
Accumulated
deficit
|
(1,060,821)
|
|
(1,003,958)
|
Total stockholders'
equity
|
116,668
|
|
170,163
|
SOURCE Lexicon Pharmaceuticals, Inc.