THE WOODLANDS, Texas,
Aug. 4, 2016 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today
reported financial results for the second quarter ended
June 30, 2016 and provided an
overview of key milestones for the company's lead drug
candidates.
"We enter the second half of the year with significant momentum,
with both telotristat etiprate and sotagliflozin," said Lexicon
President and Chief Executive Officer, Lonnel Coats. "We are looking forward to our
upcoming PDUFA date of November 30
for telotristat etiprate, as well as top-line data from two pivotal
Phase 3 clinical trials and two Phase 2 clinical trials for
sotagliflozin in type 1 diabetes by the end of the year."
Pipeline Progress
Telotristat etiprate is the first investigational drug in
clinical studies to target tryptophan hydroxylase (TPH), the
rate-limiting enzyme involved in serotonin production. Excess
production of serotonin within metastatic neuroendocrine tumor
cells can lead to carcinoid syndrome, a condition characterized by
serious consequences including frequent and debilitating diarrhea,
facial flushing, abdominal pain, and heart valve damage.
On May 30, 2016, Lexicon announced
that the U.S. Food and Drug Administration had granted a Priority
Review of the NDA filing for telotristat etiprate and set a
Prescription Drug User Fee Act ("PDUFA") target action date of
November 30, 2016. In addition,
the European Medicines Agency recently accepted a marketing
authorization application filed for telotristat etiprate by
Ipsen. Lexicon previously entered into a collaboration with
Ipsen to commercialize telotristat etiprate in Europe and other countries outside the U.S.
and Japan.
Sotagliflozin, which is being developed as a potential
treatment for type 1 and type 2 diabetes, is a dual inhibitor of
sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2), each of
which modulates glucose levels, and is the first investigational
medicine to target both of these two proteins.
Lexicon is conducting three Phase 3 clinical trials of
sotagliflozin in patients with type 1 diabetes, two of which have
completed enrollment and are expected to provide top-line results
in the second half of 2016. Lexicon expects that Phase 3
development of sotagliflozin in patients with type 2 diabetes will
be initiated by Sanofi by the end of 2016. Lexicon previously
entered into a collaboration with Sanofi in which Lexicon is
responsible for clinical development activities relating to type 1
diabetes and Sanofi is responsible for clinical development
activities relating to type 2 diabetes.
Financial Highlights
Revenues: Lexicon's revenues for the three months ended
June 30, 2016 increased to
$20.1 million from $0.4 million for the corresponding period in
2015, primarily due to revenues recognized from the collaboration
and license agreement with Sanofi. For the six months ended
June 30, 2016, revenues increased to
$32.6 million from $2.2 million for the corresponding period in
2015.
Research and Development Expenses: Research and
development expenses for the three months ended June 30, 2016 increased 132 percent to
$48.2 million from $20.8 million for the corresponding period in
2015, primarily due to increases in external clinical and
nonclinical research and development costs. For the six
months ended June 30, 2016, research
and development expenses increased 105 percent to $85.2 million from $41.6
million for the corresponding period in 2015.
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. The change in fair value of
the Symphony Icon purchase liability was $0.5 million and ($12,000) for the three months ended June 30, 2016 and 2015, respectively, and was
$1.4 million and $1.7 million for the six months ended
June 30, 2016 and 2015,
respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended June 30, 2016 increased 33 percent to
$8.4 million from $6.3 million for the corresponding period in
2015, primarily due to increased costs in preparation for
commercialization of telotristat etiprate. For the six months
ended June 30, 2016, general and
administrative expenses increased 40 percent to $16.8 million from $12.0
million for the corresponding period in 2015.
Consolidated Net Loss: Net loss for the three months
ended June 30, 2016 was $38.1 million, or $0.37 per share, compared to a net loss of
$28.1 million, or $0.27 per share, in the corresponding period in
2015. Net loss for the six months ended June 30, 2016 was $73.0
million, or $0.70 per share,
compared to a net loss of $56.2
million, or $0.54 per share,
in the corresponding period in 2015. For the three and six
months ended June 30, 2016, net loss
included non-cash, stock-based compensation expense of $2.0 million and $3.8
million, respectively. For the three and six months
ended June 30, 2015, net loss
included non-cash, stock-based compensation expense of $1.8 million and $3.7
million, respectively.
Cash and Investments: As of June
30, 2016, Lexicon had $429.4
million in cash and investments, as compared to $477.1 million as of March
31, 2016 and $521.4 million as
of December 31, 2015.
Lexicon Conference Call
Lexicon management will hold a conference call to discuss its
clinical development progress and financial results at 10:00 a.m. Eastern Time on August 4, 2016. 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 59762271. 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 4, 2016.
About Lexicon
Lexicon is a fully integrated biopharmaceutical company that is
applying a unique approach to gene science, based on Nobel
Prize-winning technology, to discover and develop precise medicines
for patients with serious, chronic conditions. Through its
Genome5000™ program, Lexicon scientists have studied the role and
function of nearly 5,000 genes over the last 20 years and have
identified more than 100 protein targets with therapeutic potential
in a range of diseases. Through the precise targeting of these
proteins, Lexicon is pioneering the discovery and development of
innovative medicines to safely and effectively treat disease.
Lexicon has a pipeline of promising drug candidates in clinical and
pre-clinical development in oncology, diabetes and metabolism. For
additional information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's clinical development of
telotristat etiprate (LX1032) and sotagliflozin (LX4211) 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, 2015, 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)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative agreements
|
|
$
20,001
|
|
$
338
|
|
$
32,495
|
|
$
2,130
|
Subscription and license fees
|
|
88
|
|
38
|
|
88
|
|
38
|
Total revenues
|
|
20,089
|
|
376
|
|
32,583
|
|
2,168
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, including stock-based compensation of $973, $868, $1,962 and $1,972,
respectively
|
|
48,216
|
|
20,769
|
|
85,218
|
|
41,634
|
Increase (decrease) in
fair value of Symphony Icon, Inc. purchase liability
|
|
478
|
|
(12)
|
|
1,443
|
|
1,741
|
General and
administrative, including stock-based compensation
of $984, $920, $1,830 and $1,769,
respectively
|
|
8,416
|
|
6,307
|
|
16,814
|
|
12,008
|
Total operating expenses
|
|
57,110
|
|
27,064
|
|
103,475
|
|
55,383
|
Loss from
operations
|
|
(37,021)
|
|
(26,688)
|
|
(70,892)
|
|
(53,215)
|
Interest
expense
|
|
(1,638)
|
|
(1,655)
|
|
(3,287)
|
|
(3,357)
|
Interest and other
income, net
|
|
547
|
|
269
|
|
1,184
|
|
422
|
Consolidated net
loss
|
|
$
(38,112)
|
|
$
(28,074)
|
|
$
(72,995)
|
|
$
(56,150)
|
|
|
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$
(0.37)
|
|
$
(0.27)
|
|
$
(0.70)
|
|
$
(0.54)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing consolidated net loss per common
share, basic and
diluted
|
|
103,830
|
|
103,608
|
|
103,756
|
|
103,562
|
Consolidated
Balance Sheet Data
|
As of
June 30,
|
|
As of
December 31,
|
(In
thousands)
|
2016
|
|
2015
|
|
(unaudited)
|
|
|
Cash and
investments
|
$
429,365
|
|
$
521,352
|
Property and
equipment, net
|
20,350
|
|
21,227
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,357
|
|
53,357
|
Total
assets
|
558,134
|
|
651,960
|
Deferred
revenue
|
153,716
|
|
185,650
|
Current and long-term
debt
|
102,198
|
|
102,936
|
Other long-term
liabilities
|
14,037
|
|
14,367
|
Accumulated
deficit
|
(1,181,929)
|
|
(1,108,934)
|
Total stockholders'
equity
|
217,333
|
|
285,850
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/lexicon-pharmaceuticals-provides-clinical-pipeline-update-and-reports-2016-second-quarter-financial-results-300309030.html
SOURCE Lexicon Pharmaceuticals, Inc.