THE WOODLANDS, Texas,
April 29, 2015 /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 ended
March 31, 2015.
"We anticipate 2015 being a pivotal year for Lexicon and our two
lead drug candidates, telotristat etiprate and sotagliflozin," said
Lonnel Coats, Lexicon's president and chief executive officer.
"During this quarter, we made significant progress in the
development of both programs by completing enrollment in our
pivotal Phase 3 trial of telotristat etiprate and initiating
screening in our first pivotal Phase 3 trial of sotagliflozin."
Progress in Clinical Pipeline
- Telotristat etiprate (LX1032): Lexicon completed enrollment in
TELESTAR, its pivotal Phase 3 clinical trial of telotristat
etiprate for patients with carcinoid syndrome. The company expects
to announce top-line data from the TELESTAR trial in the third
quarter of 2015. Telotristat etiprate is an inhibitor of tryptophan
hydroxylase (TPH) that reduces peripheral serotonin production
without affecting brain serotonin levels. The company will complete
enrollment on April 30, 2015 in
TELECAST, its companion study which is being conducted in order to
obtain additional safety data.
- Sotagliflozin (LX4211): Lexicon has commenced enrollment of
patients in the first of its two pivotal Phase 3 clinical trials of
sotagliflozin for type 1 diabetes and is preparing to initiate
screening in the second pivotal Phase 3 study. Sotagliflozin is a
dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and
SGLT2). In parallel with Phase 3 development, Lexicon is conducting
a Phase 2 clinical trial of sotagliflozin in collaboration with
JDRF focused on young adults with type 1 diabetes and high A1C,
representative of a population of particularly high unmet
need.
Expansion of Commercialization Collaboration
In March 2015, Lexicon expanded
its October 2014 collaboration
agreement with Ipsen Pharma SAS to include rights for Ipsen to
commercialize telotristat etiprate in Canada. Under the
expanded alliance, Lexicon retains sole rights to commercialize
telotristat etiprate in the United
States and Japan. Lexicon is eligible to receive up to
$5 million in upfront and
pre-commercialization milestones. Net sales in Canada will be aggregated with those in
Europe and other territories
licensed to Ipsen for purposes of the royalties and sales
milestones to be paid to Lexicon under the agreement.
Financial Results
Revenues: Lexicon's revenues for the three months
ended March 31, 2015 increased to
$1.8 million from $0.3 million for the corresponding period in
2014, primarily due to revenues recognized from the license and
collaboration agreement with Ipsen.
Research and Development Expenses: Research and
development expenses for the three months ended March 31, 2015 decreased 13 percent to
$20.9 million from $24.0 million for the corresponding period in
2014, primarily due to reductions in personnel costs as a result of
the restructuring in 2014, partially offset by increases in
external clinical research and development costs.
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 March 31,
2015, the fair value of the Symphony Icon purchase liability
increased by $1.8 million as compared
to an increase of $1.1 million in the
corresponding period in 2014.
General and Administrative Expenses: General and
administrative expenses for the three months ended March 31, 2015 was $5.7
million, consistent with the corresponding period in
2014.
Consolidated Net Loss: Net loss for the three
months ended March 31, 2015 was
$28.1 million, or $0.04 per share, compared to a net loss of
$30.8 million, or $0.06 per share, in the corresponding period in
2014. For the three months ended March
31, 2015 and 2014, net loss included non-cash, stock-based
compensation expense of $2.0 million
and $2.3 million,
respectively.
Cash and Investments: As of March 31, 2015, Lexicon had $315.1 million in cash and investments, as
compared to $339.3 million as of
December 31, 2014.
Lexicon Conference Call
Lexicon management will hold a
conference call to discuss its clinical development progress and
financial results at 5:00 p.m. Eastern
Time on April 29, 2015.
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 37172080. 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 May 29, 2015.
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, 2014, 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
March
31,
|
|
(In thousands,
except per share data)
|
|
2015
|
|
2014
|
|
|
|
(unaudited)
|
|
Revenues:
|
|
|
|
|
|
Collaborative agreements
|
|
$ 1,792
|
|
$ 172
|
|
Subscription and license fees
|
|
-
|
|
105
|
|
Total revenues
|
|
1,792
|
|
277
|
|
Operating
expenses:
|
|
|
|
|
|
Research and
development, including stock-based compensation of $1,104 and $1,458, respectively
|
|
20,865
|
|
23,953
|
|
Increase in fair value
of Symphony Icon, Inc. purchase liability
|
|
1,753
|
|
1,142
|
|
General and
administrative, including stock-based compensation
of $849 and $792, respectively
|
|
5,701
|
|
5,654
|
|
Total operating expenses
|
|
28,319
|
|
30,749
|
|
Loss from
operations
|
|
(26,527)
|
|
(30,472)
|
|
Interest
expense
|
|
(1,702)
|
|
(457)
|
|
Interest and other
income, net
|
|
153
|
|
94
|
|
Consolidated net
loss
|
|
$ (28,076)
|
|
$ (30,835)
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$ (0.04)
|
|
$ (0.06)
|
|
|
|
|
|
|
|
Shares used in
computing consolidated net loss per common share, basic
and diluted
|
|
724,613
|
|
513,955
|
|
Consolidated
Balance Sheet Data
|
As of March
31,
|
|
As of December
31,
|
(In
thousands)
|
2015
|
|
2014
|
|
(unaudited)
|
|
|
Cash and
investments
|
$ 315,097
|
|
$ 339,339
|
Assets held for
sale
|
23,849
|
|
23,849
|
Property and
equipment, net
|
732
|
|
1,080
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,357
|
|
53,557
|
Total
assets
|
444,682
|
|
471,376
|
Deferred
revenue
|
14,019
|
|
14,297
|
Current and long-term
debt
|
107,211
|
|
107,667
|
Other long-term
liabilities
|
23,259
|
|
23,535
|
Accumulated
deficit
|
(1,132,328)
|
|
(1,104,252)
|
Total stockholders'
equity
|
257,607
|
|
284,018
|
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SOURCE Lexicon Pharmaceuticals, Inc.