THE WOODLANDS, Texas,
March 3, 2017 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today
reported financial results for the three months and year ended
December 31, 2016 and provided an
overview of key milestones for the company's lead drug
candidates.
"Lexicon made great strides in 2016, achieving important
clinical and regulatory milestones and laying the groundwork for
becoming a commercial pharmaceutical company," said Lonnel Coats, Lexicon's president and chief
executive officer. "With this week's FDA approval of
XERMELOTM Lexicon has become one of a select few
biopharmaceutical companies to bring to market on its own in
the United States an innovation
that was first discovered in its own labs."
Pipeline Progress
XERMELO™ (telotristat ethyl) 250 mg was approved by the
U.S. Food and Drug Administration (FDA) as the first and only
orally administered therapy for the treatment of carcinoid syndrome
diarrhea in combination with somatostatin analog (SSA) therapy in
adults inadequately controlled by SSA therapy. Carcinoid
syndrome is a rare and debilitating condition that affects people
with metastatic neuroendocrine tumors (mNETs) and is characterized
by frequent and debilitating diarrhea that often prevents patients
from leading active, predictable lives, as well as by facial
flushing, abdominal pain, fatigue and, over time, heart valve
damage. XERMELO targets tryptophan hydroxylase, an enzyme
that mediates excess serotonin production inside mNET cells,
providing a new treatment option for patients suffering from
carcinoid syndrome diarrhea.
Lexicon has built the in-house capability and infrastructure to
launch and market XERMELO in the U.S., where it retains all
commercialization rights. Lexicon also retains rights to
market telotristat ethyl in Japan.
Lexicon has established a license and collaboration agreement with
Ipsen to commercialize telotristat ethyl in Europe and other countries outside of U.S. and
Japan. For more information about
XERMELO, please visit www.xermelo.com.
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 that targets both of these two proteins.
In December, Lexicon announced positive top-line results of its
second pivotal Phase 3 clinical trial (inTandem2) of sotagliflozin
in 782 patients with type 1 diabetes, showing a statistically
significant reduction in A1C at 24 weeks on a background of
optimized insulin, meeting the study's primary endpoint.
Top-line results from the Phase 3 study showed that patients
treated with sotagliflozin had mean A1C reductions from baseline of
0.39% on 200mg once daily sotagliflozin dose (p<0.001) and 0.37%
on 400mg once daily sotagliflozin dose (p<0.001), as compared to
a reduction of 0.03% on placebo after 24 weeks of treatment,
meeting the study's primary endpoint. Sotagliflozin was
generally well tolerated during the 24-week treatment period.
The number of patients with severe hypoglycemic events was seven
(2.7%), ten (3.8%) and six (2.3%) in the placebo, 200mg and 400mg
dose arms, respectively. The number of patients with diabetic
ketoacidosis events was none (0.0%), one (0.4%) and three (1.1%) in
the placebo, 200mg and 400mg dose arms, respectively.
Lexicon is conducting a third type 1 diabetes Phase 3 clinical
trial, inTandem3, which is underway globally and is studying
approximately 1,400 patients treated with sotagliflozin 400mg once
daily or placebo on a background of any insulin therapy, but
without insulin optimization prior to randomization. Results
from this third Phase 3 clinical trial are expected in
mid-2017. Lexicon also expects to report additional
efficacy and safety data in 2017 from the inTandem1 and inTandem2
studies.
Lexicon has granted Sanofi an exclusive, worldwide,
royalty-bearing right and license to develop, manufacture and
commercialize sotagliflozin. Lexicon is responsible for all
clinical development activities relating to type 1 diabetes and
retains an exclusive option to co-promote and have a significant
role, in collaboration with Sanofi, in the commercialization of
sotagliflozin for the treatment of type 1 diabetes in the United
States. Sanofi is responsible for all clinical development
and commercialization of sotagliflozin for the treatment of type 2
diabetes worldwide and is solely responsible for the
commercialization of sotagliflozin for the treatment of type 1
diabetes outside the United
States. Sanofi commenced Phase 3 clinical trials for
sotagliflozin in patients with type 2 diabetes in late 2016.
Additional Programs: In late 2016, Lexicon
initiated a Phase 1 clinical trial of LX2761, an
orally-delivered small molecule compound for the potential
treatment of diabetes. LX2761 is an internally generated
compound and is designed to inhibit SGLT1 locally in the
gastrointestinal tract without any significant inhibition of SGLT2
in the kidney. Also in 2016, Lexicon obtained exclusive
research, development and commercialization rights to
LX9211, a development candidate for neuropathic pain that
was jointly developed by Lexicon and Bristol-Myers Squibb Company
as part of their neuroscience drug discovery alliance.
Additional small molecule compounds acting through the same target
as LX9211 are also included in the exclusive arrangement.
LX9211 has completed IND-enabling studies, with Phase 1 clinical
trials anticipated to commence during 2017.
Financial Highlights
Revenues: Lexicon's revenues for the three months ended
December 31, 2016 decreased to
$23.0 million from $127.3 million for the corresponding period in
2015, primarily due to the recognition of revenues from the upfront
payment received under the collaboration and license agreement with
Sanofi. For the year ended December 31, 2016, revenues
decreased to $83.3 million from
$130.0 million for the
corresponding period in 2015.
Research and Development Expenses: Research and
development expenses for the three months ended December 31, 2016 increased 33 percent to
$40.4 million from $30.4 million for the corresponding period in
2015, primarily due to increases in external clinical development
costs relating to sotagliflozin. For the year ended
December 31, 2016, research and
development expenses increased 87 percent to $178.2 million from $95.2 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 and $0.8 million for the three months ended
December 31, 2016 and 2015, respectively, and was
$(0.7) million and $5.9 million for the year ended
December 31, 2016 and 2015, respectively.
General and Administrative Expenses: General and
administrative expenses for the three months ended
December 31, 2016 increased 117 percent to $14.0 million from $6.4 million for the corresponding period in
2015, primarily due to increased costs in preparation for
commercialization of XERMELO. For the year ended
December 31, 2016, general and administrative expenses
increased 81 percent to $43.0 million from $23.8 million for the corresponding period
in 2015.
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
$1.2 million and $3.6 million for the three months and year ended
December 31, 2015, respectively as a result of writing down
the value of the buildings to the estimated net selling price.
Consolidated Net Loss: Net loss for the three months
ended December 31, 2016 was $32.4 million, or $0.31 per share, compared to a net profit of
$86.8 million, or $0.76 per diluted share, in the corresponding
period in 2015. Net loss for the year ended December 31,
2016 was $141.4 million, or
$1.36 per share, compared to a net
loss of $4.7 million, or
$0.05 per share, in the corresponding
period in 2015. For the three months and year ended
December 31, 2016, net loss included non-cash, stock-based
compensation expense of $1.7 million and $7.5 million, respectively. 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.
Cash and Investments: As of December 31, 2016,
Lexicon had $346.5 million in
cash and investments, as compared to $395.6 million as of September 30, 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 am Eastern Time on March 3, 2017. 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 6855552. 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 3, 2017.
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 significant
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. In addition to XERMELO, Lexicon has a pipeline of
promising drug candidates in clinical and pre-clinical development
in diabetes and metabolism and neuropathic pain. For additional
information please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's commercialization of
XERMELO (telotristat ethyl) 250 mg and clinical development of
sotagliflozin. 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
the degree of market acceptance of XERMELO, the availability of
coverage and reimbursement for XERMELO, Lexicon's dependence on
third parties for manufacturing and distribution of XERMELO,
Lexicon's compliance with applicable legal and regulatory
requirements and other factors relating to the commercialization of
XERMELO. Other risks include Lexicon's ability to meet its capital
requirements, successfully conduct preclinical and clinical
development and obtain necessary regulatory approvals of
sotagliflozin and its other potential drug candidates, 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. Any of these risks, uncertainties and other factors 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
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year
Ended
|
Consolidated
Statements of Operations Data
|
|
December
31,
|
|
December
31,
|
(In thousands, except
per share data)
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
(Unaudited)
|
|
(Unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Collaborative
agreements
|
|
$
23,001
|
|
$
127,093
|
|
$
83,182
|
|
$
129,728
|
Subscription and license
fees
|
|
36
|
|
187
|
|
155
|
|
286
|
Total revenues
|
|
23,037
|
|
127,280
|
|
83,337
|
|
130,014
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and development,
including stock-based compensation of $925, $828, $3,938, $3,693 respectively
|
|
|
|
|
|
|
|
|
|
40,400
|
|
30,442
|
|
178,151
|
|
95,187
|
Increase (decrease) in fair
value of Symphony Icon purchase liability
|
|
-
|
|
782
|
|
(703)
|
|
5,927
|
General and administrative,
including stock-based compensation of $805, $602, $3,514, $3,150 respectively
|
|
|
|
|
|
|
|
|
|
13,967
|
|
6,448
|
|
43,044
|
|
23,835
|
Impairment loss on
buildings
|
|
-
|
|
1,248
|
|
-
|
|
3,597
|
Total operating expenses
|
|
54,367
|
|
38,920
|
|
220,492
|
|
128,546
|
Income (loss) from
operations
|
|
(31,330)
|
|
88,360
|
|
(137,155)
|
|
1,468
|
Interest
expense
|
|
(1,634)
|
|
(1,678)
|
|
(6,567)
|
|
(6,722)
|
Interest and other
income, net
|
|
545
|
|
68
|
|
2,293
|
|
572
|
Consolidated net
income (loss)
|
|
$ (32,419)
|
|
$
86,750
|
|
$
(141,429)
|
|
$
(4,682)
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net
income (loss) per common share, basic
|
|
|
$
(0.31)
|
|
$
0.84
|
|
$
(1.36)
|
|
$
(0.05)
|
Consolidated net
income (loss) per common share, diluted
|
|
|
$
(0.31)
|
|
$
0.76
|
|
$
(1.36)
|
|
$
(0.05)
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per common share, basic
|
|
|
|
104,052
|
|
103,623
|
|
103,863
|
|
103,591
|
Shares used in
computing net income (loss) per common share, diluted
|
|
|
|
104,052
|
|
115,764
|
|
103,863
|
|
103,591
|
|
|
|
|
|
Consolidated
Balance Sheet Data
|
|
As of December
31,
|
|
As of December
31,
|
(In
thousands)
|
|
2016
|
|
2015
|
|
|
|
|
(Unaudited)
|
|
|
Cash and
investments
|
|
$
|
|
346,504.00
|
|
$
|
|
521,352
|
Property and
equipment, net
|
|
|
19,390
|
|
|
|
21,227
|
Goodwill
|
|
|
44,543
|
|
|
|
44,543
|
Other intangible
assets
|
|
|
53,357
|
|
|
|
53,357
|
Total
assets
|
|
|
475,625
|
|
|
|
651,960
|
Accounts
payable
|
|
|
52,877
|
|
|
|
19,725
|
Accrued
liabilities
|
|
|
32,114
|
|
|
|
24,757
|
Deferred
revenue
|
|
|
112,306
|
|
|
|
185,650
|
Current and long-term
debt
|
|
|
101,447
|
|
|
|
102,936
|
Accumulated
deficit
|
|
|
(1,250,363)
|
|
|
|
(1,108,934)
|
Total stockholders'
equity
|
|
|
157,401
|
|
|
|
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-fourth-quarter-and-full-year-financial-results-300417432.html
SOURCE Lexicon Pharmaceuticals, Inc.