THE WOODLANDS, Texas,
Nov. 4, 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 nine
months ended September 30, 2014.
"We made considerable progress this quarter in building the
foundation necessary to realize the full value of telotristat
etiprate," said Lonnel Coats, Lexicon's president and chief
executive officer. "Our new collaboration with Ipsen addresses a
major aspect of our commercialization strategy and provides us the
opportunity to more effectively commercialize telotristat etiprate
in markets around the world."
Lexicon recently announced a collaboration agreement with Ipsen
Pharma SAS for the commercialization of telotristat etiprate, with
a focus on carcinoid syndrome, in markets outside the United States, Canada and Japan. Under the agreement,
Lexicon is eligible to receive up to approximately $145 million in aggregate upfront and milestone
payments, including an upfront payment of $23 million. In addition, Lexicon is
entitled to receive royalties on net sales of telotristat etiprate
by Ipsen.
Progress in Clinical Pipeline
- Sotagliflozin (LX4211): Lexicon continues to make progress in
its preparations for the initiation of phase 3 clinical studies of
sotagliflozin, a dual inhibitor of sodium-glucose transporters 1
and 2, in type 1 diabetes, with the anticipation that such clinical
trials will commence in early 2015.
- 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 September 30, 2014 increased to
$0.4 million from $0.2 million for the corresponding period in
2013, primarily due to increased technology license fees. For
the nine months ended September 30,
2014, revenues increased 69 percent to $1.4 million from $0.8
million for the corresponding period in 2013.
Research and Development Expenses: Research and
development expenses for the three months ended September 30, 2014 decreased five percent to
$24.1 million from $25.4 million for the corresponding period in
2013, primarily due to reductions 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. These
reductions were partially offset by increases in external clinical
and preclinical research and development costs. For the nine
months ended September 30, 2014,
research and development expenses decreased to $69.2 million from $69.4
million for the corresponding period in 2013.
Change 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 September 30,
2014, the fair value of the Symphony Icon purchase liability
decreased by $1.1 million as compared
to an increase of $1.3 million in the
corresponding period in 2013. The increase in fair value of
the Symphony Icon purchase liability was $0.5 million and $3.1
million for the nine months ended September 30, 2014 and 2013,
respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended September 30, 2014 decreased two percent to
$4.6 million from $4.7 million for the corresponding period in
2013. For the nine months ended September 30, 2014, general and administrative
expenses increased 13 percent to $15.4
million from $13.7 million for
the corresponding period in 2013.
Impairment Loss on Buildings: In September 2014, Lexicon determined its buildings
and land should be classified as assets held for sale.
Lexicon recognized a non-cash impairment loss on its buildings of
$13.1 million for the three and nine
months ended September 30, 2014, as a
result of writing down the buildings to the estimated net selling
price.
Consolidated Net Loss: Net loss for the three
months ended September 30, 2014 was
$40.5 million, or $0.08 per share, compared to a net loss of
$31.7 million, or $0.06 per share, in the corresponding period in
2013. Net loss for the nine months ended September 30, 2014 was $97.4 million, or $0.19 per share, compared to a net loss of
$86.7 million, or $0.17 per share, for the corresponding period in
2013. For the three and nine months ended September 30, 2014, net loss included non-cash,
stock-based compensation expense of $1.5
million and $5.6 million,
respectively. 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.
Cash and Investments: As of September 30, 2014, Lexicon had $57.9 million in cash and investments, as
compared to $79.0 million as of
June 30, 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 third quarter of 2014 at 5:00 p.m. Eastern Time on November 4, 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 29992481. 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 4, 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 sotagliflozin (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 sotagliflozin and
telotristat etiprate. 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 sotagliflozin and telotristat
etiprate 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
September
30,
|
|
Nine Months
Ended September
30,
|
(In thousands,
except per share data)
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative research
|
|
$ 312
|
|
$ 238
|
|
$ 1,111
|
|
$ 733
|
Subscription and license fees
|
|
107
|
|
-
|
|
261
|
|
79
|
Total revenues
|
|
419
|
|
238
|
|
1,372
|
|
812
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, including stock-based
compensation of $797, $1,027,
$3,195 and $3,379, respectively
|
|
24,108
|
|
25,400
|
|
69,248
|
|
69,419
|
Increase (decrease) in
fair value of Symphony Icon, Inc. purchase liability
|
|
(1,072)
|
|
1,338
|
|
518
|
|
3,079
|
General and
administrative, including stock-based
compensation of $697, $723,
$2,389 and $2,349, respectively
|
|
4,617
|
|
4,716
|
|
15,423
|
|
13,709
|
Impairment loss on
buildings
|
|
13,102
|
|
-
|
|
13,102
|
|
-
|
Total operating expenses
|
|
40,755
|
|
31,454
|
|
98,291
|
|
86,207
|
Loss from
operations
|
|
(40,336)
|
|
(31,216)
|
|
(96,919)
|
|
(85,395)
|
Interest
income
|
|
5
|
|
39
|
|
17
|
|
136
|
Interest
expense
|
|
(449)
|
|
(492)
|
|
(1,361)
|
|
(1,494)
|
Other income,
net
|
|
282
|
|
11
|
|
902
|
|
41
|
Consolidated net
loss
|
|
$ (40,498)
|
|
$ (31,658)
|
|
$ (97,361)
|
|
$ (86,712)
|
|
|
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$ (0.08)
|
|
$ (0.06)
|
|
$ (0.19)
|
|
$ (0.17)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss attributable to Lexicon Pharmaceuticals,
Inc. per common share, basic and diluted
|
|
514,796
|
|
513,419
|
|
514,461
|
|
512,980
|
Consolidated
Balance Sheet Data
|
As of September
30,
|
|
As of December
31,
|
(In
thousands)
|
2014
|
|
2013
|
|
(unaudited)
|
|
|
Cash and
investments
|
$ 57,869
|
|
$ 129,128
|
Assets held for
sale
|
23,849
|
|
-
|
Property and
equipment, net
|
1,494
|
|
41,362
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,557
|
|
53,557
|
Total
assets
|
187,522
|
|
274,160
|
Deferred
revenue
|
13,464
|
|
13,600
|
Current and long-term
debt
|
20,609
|
|
21,877
|
Other long-term
liabilities.
|
34,005
|
|
32,386
|
Accumulated
deficit
|
(1,101,319)
|
|
(1,003,958)
|
Total stockholders'
equity
|
77,824
|
|
170,163
|
SOURCE Lexicon Pharmaceuticals, Inc.