SAN DIEGO, Nov. 3, 2014 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended September 30,
2014. For the third quarter of 2014, the Company
reported a net loss of $15.9 million,
or $0.21 loss per share, compared to
a net loss of $11.1 million, or
$0.17 loss per share, for the same
period in 2013. For the nine months ended September 30, 2014, the Company reported a net
loss of $41.1 million, or
$0.56 loss per share, as compared to
net loss of $35.4 million, or
$0.53 loss per share, for the first
three quarters of last year.
The Company's balance sheet at September
30, 2014 reflected total assets of $257.8 million, including cash, cash equivalents,
investments and receivables of $248.3
million.
"We have made significant progress over the past quarter with
our VMAT2 program, including the initiation of the Kinect 3 Phase
III study, receiving Breakthrough Therapy Designation from the FDA
for tardive dyskinesia, and starting the first clinical assessment
of NBI-98854 in children with Tourette syndrome," said Kevin Gorman, Ph.D., President and Chief
Executive Officer of Neurocrine Biosciences. "We look forward to
multiple clinical trial readouts in 2015 including Phase III
topline efficacy data for elagolix in endometriosis and Phase IIb
efficacy data for elagolix in uterine fibroids reported by our
partner AbbVie, as well as Kinect 3 Phase III topline efficacy data
and Phase Ib data in Tourette from our VMAT2 inhibitor."
Research and development expenses were $12.2 million during the third quarter of 2014,
compared to $9.5 million for the same
period in 2013. General and administrative expenses increased
from $3.2 million for the third
quarter of 2013 to $4.7 million for
the third quarter of 2014. For the nine months ended September 30, 2014, research and development
expenses were $30.9 million, compared
to $30.3 million for the same period
last year, while general and administrative expenses were
$13.0 million, compared to
$10.0 million. This increase in
year-to-date expenses is primarily due to higher personnel costs,
with share-based compensation expense representing $2.8 million of the year-to-date increase in
expenses.
Pipeline Highlights
VMAT2 Update
The Company recently initiated a Phase III study of NBI-98854,
the Kinect 3 study. The Kinect 3 study, along with the previous
efficacy studies of NBI-98854, is designed to complete the
placebo-controlled clinical efficacy evaluation of NBI-98854 in
tardive dyskinesia. The primary endpoint in the Kinect 3 study is
the mean change from baseline in the Abnormal Involuntary Movement
Scale (AIMS) as assessed by blinded central raters. The Kinect 3
study will include approximately 240 subjects randomized to either
placebo, once daily 40mg of NBI-98854 or once daily 80mg of
NBI-98854 for six weeks of placebo-controlled dosing followed by an
extension of active dosing through Week 48. The Company also
intends to conduct a separate one-year open-label safety study of
NBI-98854 to support the anticipated 2016 filing of a New Drug
Application in tardive dyskinesia.
Top-line efficacy data from the initial six weeks of
placebo-controlled dosing is expected in the second half of
2015.
The Company also recently received Breakthrough Therapy
Designation from the FDA for NBI-98854 in the treatment of tardive
dyskinesia.
The Company is also exploring NBI-98854 in an initial Tourette
syndrome clinical trial, the T-Force study. This study is an
open-label, multi-dose, two-week evaluation of 36 subjects with
Tourette syndrome. Children and adolescents enrolled in the trial
will receive once-daily dosing of NBI-98854 during a two-week
treatment period to assess both the safety and tolerability of
NBI-98854 in Tourette patients. Additionally, the Yale Global Tic
Severity Scale and the Premonitory Urge for Tics Scale will be
employed during the study to assess the impact of NBI-98854 on the
patients' Tourette symptoms. Data readout from this study is
expected in 2015.
Elagolix Update
AbbVie is currently conducting the Violet Petal Study, a Phase
III study of elagolix for endometriosis. The study is a
24-week, multinational, randomized, double-blind,
placebo-controlled study designed to evaluate the safety and
efficacy of elagolix in 875 women, age 18 to 49, with moderate to
severe endometriosis-associated pain. Approximately 160 sites
in the United States, Puerto Rico and Canada are conducting this study which
completed patient recruitment and randomization during the second
quarter. Topline efficacy data from this study is anticipated to be
available in January 2015.
AbbVie is also conducting the second Phase III study of elagolix
for endometriosis, the Solstice Study. This study is similar
in design to the Violet Petal Study and will assess 788 women, age
18 to 49, with moderate to severe endometriosis-associated pain at
more than 200 sites globally.
Elagolix is also being evaluated in women with uterine fibroids.
AbbVie is conducting a Phase IIb clinical trial evaluating
the change in menstrual blood loss of 520 women, age 18-51, with
heavy menstrual bleeding associated with uterine fibroids.
Conference Call and Webcast Today at 5:00PM Eastern Time
Neurocrine will hold a
live conference call and webcast today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants can
access the live conference call by dialing 877-888-4314 (US) or
785-424-1875 (International) using the conference ID: NBIX.
The call can also be accessed via the webcast through the
Company's website at http://www.neurocrine.com.
If you are unable to attend the webcast and would like further
information on this announcement please contact the Investor
Relations Department at Neurocrine Biosciences at
ir@neurocrine.com. A replay of the conference call will be
available approximately one hour after the conclusion of the call
by dialing 800-723-0528 (US) or 402-220-2654 (International) using
the conference ID: NBIX. The call will be archived for one
month.
Neurocrine Biosciences, Inc. discovers and develops innovative
and life-changing pharmaceuticals, in diseases with high unmet
medical needs, through its novel R&D platform, focused on
neurological and endocrine based diseases and disorders. The
Company's two lead late-stage clinical programs are elagolix, a
gonadotropin-releasing hormone antagonist for women's health that
is partnered with AbbVie Inc., and a wholly owned vesicular
monoamine transporter 2 inhibitor for the treatment of movement
disorders. Neurocrine intends to maintain certain commercial
rights to its VMAT2 inhibitor for evolution into a fully-integrated
pharmaceutical company.
Neurocrine Biosciences, Inc. news releases are available through
the Company's website via the internet at
http://www.neurocrine.com.
In addition to historical facts, this press release may
contain forward-looking statements that involve a number of risks
and uncertainties. Among the factors that could cause actual
results to differ materially from those indicated in the
forward-looking statements are risks and uncertainties associated
with Neurocrine's R&D pipeline as well as its business overall.
Specifically, the risks and uncertainties the Company faces
with respect to elagolix, include the risk that the elagolix
endometriosis Phase III clinical trials will fail to demonstrate
that elagolix is safe and effective; the risk that elagolix Phase
III clinical trials will be delayed for regulatory or other
reasons; the risk that the elagolix uterine fibroids clinical
program will not proceed to later stage clinical trials; and the
risks associated with the Company's dependence on AbbVie for
elagolix Phase III development, commercial manufacturing and
marketing and sales activities. In addition, the Company
faces risks and uncertainties with respect to the rest of the
Company's R & D pipeline including; risk that the Company's
VMAT2 Phase III clinical program will fail to demonstrate that
NBI-98854 is safe and effective; risk that the VMAT2 Phase III
program will be delayed for regulatory or other reasons; risk that
the Breakthrough Therapy designation may not result in an expedited
development and review process for NBI-98854 and may not lead to
regulatory approval; risk that the Company will be unable to
complete the Tourette syndrome Phase I clinical trial for
regulatory or other reasons; risk that the Company's research
programs will not identify pre-clinical candidates for further
development; and risk that the Company's other product
candidates will not be found to be safe and effective. With
respect to its business overall, the Company faces risk that it
will be unable to raise additional funding required to complete
development of all of its product candidates; risk relating to the
Company's dependence on contractors for clinical drug supply,
commercial manufacturing and marketing and sales activities;
uncertainties relating to patent protection and intellectual
property rights of third parties; risks and uncertainties relating
to competitive products and technological changes that may limit
demand for the Company's products if approved. The Company
also faces the other risks described in the Company's annual report
on Form 10-K for the year ended December 31,
2013 and quarterly reports on Form 10-Q for the quarters
ended March 31, 2014 and June 30, 2014. Neurocrine undertakes no
obligation to update the statements contained in this press release
after the date hereof.
NEUROCRINE
BIOSCIENCES, INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands,
except per share data)
|
(unaudited)
|
|
|
Three Months
Ended
September 30,
|
Nine Months
Ended
September 30,
|
|
2014
|
2013
|
2014
|
2013
|
Revenues:
|
|
|
|
|
License
fees
|
$
-
|
$ 729
|
$
-
|
$ 2,189
|
|
|
|
|
|
Total
revenues
|
-
|
729
|
-
|
2,189
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
12,194
|
9,490
|
30,927
|
30,330
|
General and
administrative
|
4,663
|
3,245
|
13,016
|
10,007
|
|
|
|
|
|
Total operating
expenses
|
16,857
|
12,735
|
43,943
|
40,337
|
|
|
|
|
|
Loss from
operations
|
(16,857)
|
(12,006)
|
(43,943)
|
(38,148)
|
Other
income:
|
|
|
|
|
Gain (loss) on
sale/disposal of assets
|
1
|
6
|
(4)
|
38
|
Deferred gain on real
estate
|
805
|
781
|
2,414
|
2,344
|
Investment income,
net
|
176
|
93
|
432
|
317
|
Other income (loss),
net
|
-
|
(5)
|
3
|
1
|
|
|
|
|
|
Total other
income
|
982
|
875
|
2,845
|
2,700
|
|
|
|
|
|
Net loss
|
$ (15,875)
|
$ (11,131)
|
$ (41,098)
|
$ (35,448)
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
Basic and
diluted
|
$ (0.21)
|
$ (0.17)
|
$ (0.56)
|
$ (0.53)
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
Basic and
diluted
|
75,948
|
67,199
|
74,050
|
66,868
|
NEUROCRINE
BIOSCIENCES, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
September
30,
2014
|
December 31,
2013
|
Cash, cash
equivalents and short-term investments, available for
sale
|
$
179,674
|
$
145,739
|
Other current
assets
|
4,194
|
2,723
|
|
|
|
Total current
assets
|
183,868
|
148,462
|
Property and
equipment, net
|
2,292
|
1,771
|
Long-term
investments, available for sale
|
67,148
|
-
|
Restricted
cash
|
4,443
|
4,443
|
|
|
|
Total
assets
|
$
257,751
|
$
154,676
|
|
|
|
|
|
|
Current
liabilities
|
$
14,045
|
$
11,699
|
Long-term
liabilities
|
19,669
|
22,567
|
Stockholders'
equity
|
224,037
|
120,410
|
|
|
|
Total liabilities and
stockholders' equity
|
$
257,751
|
$
154,676
|
SOURCE Neurocrine Biosciences, Inc.