THE WOODLANDS, Texas,
March 1, 2016 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today
reported financial results for the three months and year ended
December 31, 2015 and provided an
overview of key milestones for the company's lead drug
candidates.
"This has been a transformative year for Lexicon and our two
lead drug candidates, telotristat etiprate and sotagliflozin," said
Lexicon President and Chief Executive Officer Lonnel Coats. "We entered 2016 well capitalized
with more than $500 million in cash
and investments and well positioned to progress our first drug,
telotristat etiprate, to an NDA filing and, if approved, into the
market."
In November 2015, Lexicon
announced that it entered into a collaboration and license
agreement with Sanofi for the worldwide development and
commercialization of sotagliflozin. Under the terms of the
agreement, Lexicon received an upfront payment of $300 million and is eligible to receive
development, regulatory and sales milestone payments of up to
$1.4 billion. Lexicon is also
entitled to tiered, escalating royalties on net sales of
sotagliflozin.
Pipeline Progress
Telotristat etiprate is the first investigational drug in
clinical studies to target tryptophan hydroxylase (TPH), the
rate-limiting enzyme involved in the excess serotonin production
within metastatic neuroendocrine tumor cells that can lead to
carcinoid syndrome, a condition characterized by serious
consequences including frequent and debilitating diarrhea, facial
flushing, abdominal pain, and heart valve damage.
In December 2015, Lexicon
announced top-line results from its second Phase 3 study, TELECAST,
which met its primary efficacy endpoint, the percent change from
baseline in urinary 5-hydroxyindoleacetic acid (5-HIAA, the main
metabolite of serotonin) at week 12, the final week of the
double-blind treatment portion of the study (p<0.001 for both
the 250 mg and 500 mg dose arms compared to placebo). In
addition, despite a lower baseline bowel movement frequency than in
the first Phase 3 study, TELESTAR, telotristat etiprate achieved
statistically significant reductions in daily bowel movement
frequency over the 12 weeks of the study (p=0.004 for the 250 mg
dose arm and p<0.001 for the 500 mg dose arm compared to
placebo). Telotristat etiprate was well tolerated during the
double-blind treatment period, with profiles similar to placebo for
both the 250 mg and 500 mg dose arms and no overall differences
observed in gastrointestinal disorders or psychiatric disorders,
including changes in mood.
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.
Under the collaboration with Sanofi, 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
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
December 31, 2015 increased to
$127.3 million from $21.5 million for the corresponding period in
2014, primarily due to revenues recognized from the collaboration
and license agreement with Sanofi. For the year ended
December 31, 2015, revenues increased
to $130.0 million from $22.9 million for the corresponding period in
2014.
Research and Development Expenses: Research and
development expenses for the three months ended December 31, 2015 increased 52 percent to
$30.4 million from $20.0 million for the corresponding period in
2014, primarily due to increases in external clinical and
nonclinical research and development costs. For the year
ended December 31, 2015, research and
development expenses increased seven percent to $95.2 million from $89.3
million for the corresponding period in 2014.
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
December 31, 2015 and 2014, the fair
value of the Symphony Icon purchase liability increased by
$0.8 million and $0.9 million, respectively. The increase in
fair value of the Symphony Icon purchase liability was $5.9 million and $1.4
million for the year ended December
31, 2015 and 2014, respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended December 31, 2015 increased 62 percent to
$6.4 million from $4.0 million for the corresponding period in
2014, primarily due to increased costs in preparation for
commercialization of telotristat etiprate. For the year ended
December 31, 2015, general and
administrative expenses increased 23 percent to $23.8 million from $19.4
million for the corresponding period in 2014.
Impairment Loss on Buildings: In 2014, Lexicon
began to market its buildings and land in The Woodlands, Texas for sale. Lexicon
recognized non-cash impairment losses on its buildings of
$3.6 million and $13.1 million for the year ended December 31, 2015 and 2014, respectively, as a
result of writing down the buildings to the estimated net selling
price. In January 2016, Lexicon
entered into a purchase and sale agreement, under which Lexicon
agreed to sell such buildings and land, subject to the negotiation
and execution of a leaseback agreement with respect to a portion of
the buildings.
Consolidated Net Income (Loss): Net income for the three
months ended December 31, 2015 was
$86.8 million, or $0.76 per diluted share, compared to a net loss
of $2.9 million, or $0.03 per share, in the corresponding period in
2014. Net loss for the year ended December 31, 2015 was $4.7
million, or $0.05 per share,
compared to a net loss of $100.3
million, or $1.31 per share,
in the corresponding period in 2014. For the three months and
year ended December 31, 2015, net
loss included non-cash, stock-based compensation expense of
$1.4 million and $6.8 million, respectively. For the three
months and year ended December 31,
2014, net loss included non-cash, stock-based compensation
expense of $1.5 million and
$7.1 million, respectively.
Cash and Investments: As of December 31, 2015, Lexicon had $521.4 million in cash and investments, as
compared to $256.4 million as of
September 30, 2015 and $339.3 million as of December 31, 2014.
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 for 2015 at
10:00 a.m. Eastern Time on
March 1, 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
60197078. 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 April 1,
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, 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 December
31,
|
|
Year
Ended
|
December
31,
|
(In thousands,
except per share data)
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative agreements
|
|
$ 127,093
|
|
$ 21,482
|
|
$ 129,728
|
|
$ 22,593
|
Subscription and license fees
|
|
187
|
|
-
|
|
286
|
|
261
|
Total revenues
|
|
127,280
|
|
21,482
|
|
130,014
|
|
22,854
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, including stock-based compensation of $828, $825, $3,693 and $4,020,
respectively
|
|
30,442
|
|
20,031
|
|
95,187
|
|
89,279
|
Increase in fair value
of Symphony Icon, Inc. purchase liability
|
|
782
|
|
910
|
|
5,927
|
|
1,428
|
General and
administrative, including stock-based compensation
of $602, $672, $3,150 and $3,061,
respectively
|
|
6,448
|
|
3,988
|
|
23,835
|
|
19,411
|
Impairment loss on
buildings
|
|
1,248
|
|
-
|
|
3,597
|
|
13,102
|
Total operating expenses
|
|
38,920
|
|
24,929
|
|
128,546
|
|
123,220
|
Income (loss) from
operations
|
|
88,360
|
|
(3,447)
|
|
1,468
|
|
(100,366)
|
Interest
expense
|
|
(1,678)
|
|
(892)
|
|
(6,722)
|
|
(2,253)
|
Interest and other
income, net
|
|
68
|
|
1,336
|
|
572
|
|
2,255
|
Consolidated net
income (loss) before taxes
|
|
86,750
|
|
(3,003)
|
|
(4,682)
|
|
(100,364)
|
Income tax
benefit
|
|
-
|
|
70
|
|
-
|
|
70
|
Consolidated net
income (loss)
|
|
$ 86,750
|
|
$ (2,933)
|
|
$ (4,682)
|
|
$ (100,294)
|
|
|
|
|
|
|
|
|
|
Consolidated net
income (loss) per common share, basic
|
|
$ 0.84
|
|
$ (0.03)
|
|
$ (0.05)
|
|
$ (1.31)
|
Consolidated net
income (loss) per common share, diluted
|
|
$ 0.76
|
|
$ (0.03)
|
|
$ (0.05)
|
|
$ (1.31)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per common share, basic
|
|
103,623
|
|
84,813
|
|
103,591
|
|
76,347
|
Shares used in
computing net income (loss) per common share, diluted
|
|
115,764
|
|
84,813
|
|
103,591
|
|
76,347
|
|
|
Consolidated
Balance Sheet Data
|
As of December
31,
|
|
As of December
31,
|
(In
thousands)
|
2015
|
|
2014
|
|
(unaudited)
|
|
|
Cash and
investments
|
$ 521,352
|
|
$ 339,339
|
Assets held for
sale
|
-
|
|
23,849
|
Property and
equipment, net
|
21,227
|
|
1,080
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,357
|
|
53,557
|
Total
assets
|
654,832
|
|
471,376
|
Deferred
revenue
|
185,650
|
|
14,297
|
Current and long-term
debt
|
105,808
|
|
107,667
|
Other long-term
liabilities
|
14,367
|
|
23,535
|
Accumulated
deficit
|
(1,108,934)
|
|
(1,104,252)
|
Total stockholders'
equity
|
285,850
|
|
284,018
|
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SOURCE Lexicon Pharmaceuticals, Inc.