THE WOODLANDS, Texas,
May 3, 2016 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial
results for the three months ended March 31,
2016 and provided an overview of key milestones for the
company's lead drug candidates.
"We closed out the quarter with the filing of the NDA for
telotristat etiprate, an important milestone for the company," said
Lexicon President and Chief Executive Officer, Lonnel Coats. "We look forward to working
closely with the FDA during the review process of this
investigational treatment for the care of patients living with
carcinoid syndrome."
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 March 30, 2016, Lexicon
announced that it had submitted a New Drug Application to the U.S.
Food and Drug Administration seeking approval for the marketing and
sale of telotristat etiprate, an oral drug for the treatment of
carcinoid syndrome. The FDA has a 60-day filing review period
to determine whether the NDA is complete and acceptable for
filing. Lexicon has requested a Priority Review by the FDA as
part of the NDA filing.
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 recently entered into a collaboration with Sanofi, in
which Lexicon will continue to be responsible for clinical
development activities relating to type 1 diabetes and Sanofi will
be responsible for clinical development activities relating to type
2 diabetes. Lexicon is conducting three Phase 3 clinical
trials of sotagliflozin in patients with type 1 diabetes, one of
which has already completed enrollment and the second of which has
completed patient screening, and expects top-line results from its
two pivotal Phase 3 clinical trials to be available 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.
Financial Highlights
Revenues: Lexicon's revenues for the three months ended
March 31, 2016 increased to
$12.5 million from $1.8 million for the corresponding period in
2015, primarily due to revenues recognized from the collaboration
and license agreement with Sanofi.
Research and Development Expenses: Research and
development expenses for the three months ended March 31, 2016 increased 77 percent to
$37.0 million from $20.9 million for the corresponding period in
2015, primarily due to increases in external clinical and
nonclinical 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, 2016 and 2015, the fair
value of the Symphony Icon purchase liability increased by
$1.0 million and $1.8 million, respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended March 31, 2016 increased 47 percent to
$8.4 million from $5.7 million for the corresponding period in
2015, primarily due to increased costs in preparation for
commercialization of telotristat etiprate.
Consolidated Net Loss: Net loss for the three months
ended March 31, 2016 was $34.9 million, or $0.34 per share, compared to a net loss of
$28.1 million, or $0.27 per share, in the corresponding period in
2015. For the three months ended March
31, 2016 and 2015, net loss included non-cash, stock-based
compensation expense of $1.8 million
and $2.0 million, respectively.
Cash and Investments: As of March
31, 2016, Lexicon had $477.1
million in cash and investments, as compared to $521.4 million as of December 31, 2015.
Reverse Stock Split: In May
2015, Lexicon completed a one-for-seven reverse stock
split. All references to common shares and per-share data for
all periods presented in this release have been adjusted to give
effect to this reverse stock split.
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 May 3, 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 4144358. 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 June 3, 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
March
31,
|
(In thousands, except
per share data)
|
|
2016
|
|
2015
|
|
|
(unaudited)
|
|
|
|
|
|
Revenues from
collaborative agreements
|
|
$ 12,494
|
|
$ 1,792
|
Operating
expenses:
|
|
|
|
|
Research and
development, including stock-based compensation
of $989
and $1,104, respectively
|
|
37,002
|
|
20,865
|
Increase in fair value
of Symphony Icon, Inc. purchase liability
|
|
965
|
|
1,753
|
General and
administrative, including stock-based
compensation of $846 and $849,
respectively
|
|
8,398
|
|
5,701
|
Total operating expenses
|
|
46,365
|
|
28,319
|
Loss from
operations
|
|
(33,871)
|
|
(26,527)
|
Interest
expense
|
|
(1,649)
|
|
(1,702)
|
Interest and other
income, net
|
|
637
|
|
153
|
Consolidated net
loss
|
|
$ (34,883)
|
|
$(28,076)
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$ (0.34)
|
|
$ (0.27)
|
|
|
|
|
|
Shares used in
computing consolidated net loss per common share, basic
and
diluted
|
|
103,682
|
|
103,516
|
Consolidated
Balance Sheet Data
|
As of March
31,
|
|
As of December
31,
|
(In
thousands)
|
2016
|
|
2015
|
|
(unaudited)
|
|
|
Cash and
investments
|
$ 477,146
|
|
$
521,352
|
Property and
equipment, net
|
20,753
|
|
21,227
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,357
|
|
53,557
|
Total
assets
|
611,341
|
|
651,960
|
Deferred
revenue
|
173,463
|
|
185,650
|
Current and long-term
debt
|
102,570
|
|
102,936
|
Other long-term
liabilities
|
14,593
|
|
14,367
|
Accumulated
deficit
|
(1,143,817)
|
|
(1,108,934)
|
Total stockholders'
equity
|
252,881
|
|
285,850
|
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SOURCE Lexicon Pharmaceuticals, Inc.