SAN DIEGO, Aug. 6, 2014 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended June 30,
2014. For the second quarter of 2014, the Company
reported a net loss of $13.4 million,
or $0.18 loss per share, compared to
a net loss of $12.2 million, or
$0.18 loss per share, for the same
period in 2013. For the six months ended June 30, 2014, the Company reported a net loss of
$25.2 million, or $0.35 loss per share, as compared to net loss of
$24.3 million, or $0.36 loss per share, for the first half of last
year.
The Company's balance sheet at June 30,
2014 reflected total assets of $269.5
million, including cash, cash equivalents, investments and
receivables of $261.5
million.
"We are very pleased with our recent interactions with the FDA
concerning our VMAT2 inhibitor NBI-98854 and the path forward to an
NDA filing in tardive dyskinesia," said Kevin Gorman, Ph.D., President and Chief
Executive Officer of Neurocrine Biosciences. "Based on the
results of the End-of-Phase II meeting, we will conduct a single
placebo-controlled Phase III trial (Kinect 3). We look forward to
initiating the Kinect 3 pivotal trial later this year."
Research and development expenses were $10.2 million during the second quarter of 2014
compared to $10.5 million for the
same period in 2013. For the six months ended
June 30, 2014, research and
development expenses were $18.7
million, compared to $20.8
million for the same period last year. This
decrease was due to lower external clinical development expense
related to the Company's VMAT2 inhibitor, NBI-98854, which
substantially completed Phase II development in late 2013 and is
currently in preparation for Phase III development. This
decrease was offset by higher research and development personnel
costs primarily related to higher share-based compensation
expense.
General and administrative expenses increased from $3.4 million for the second quarter of 2013 to
$4.2 million for the second quarter
of 2014. For the six months ended June
30, 2014 general and administrative expenses were
$8.4 million, compared to
$6.8 million for the first half of
2013. The increase in general and administrative expense is
primarily due to higher share-based compensation expense.
Pipeline Highlights
VMAT2 Update
The Company recently held an End-of-Phase II meeting with the
FDA for its VMAT2 inhibitor, NBI-98854. The FDA reviewed the
current data package and clinical development plan for NBI-98854
and commented on the overall proposal for Phase III development to
support the registration of NBI-98854 in the United States as a treatment for tardive
dyskinesia. Based on the results of this meeting and the
related minutes, the Company will conduct a single
placebo-controlled Phase III study of NBI-98854, the Kinect 3
study. The Kinect 3 study, along with the previous efficacy studies
of NBI-98854, will complete the placebo-controlled clinical
efficacy evaluation of NBI-98854 in tardive dyskinesia. The primary
endpoint in the Kinect 3 study will be 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 6
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.
The Company is also expecting to submit an Investigational New
Drug application for NBI-98854 in Tourette syndrome later this
month and plans to commence the clinical program in Tourette
syndrome patients this year.
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.
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 studied for utilization in uterine
fibroids. AbbVie is conducting a Phase IIb clinical trial
evaluating the change in uterine blood loss of 520 women, age
18-51, with heavy uterine bleeding due to uterine fibroids.
Conference Call and Webcast Tomorrow at 8:00AM Eastern Time
Neurocrine will hold a live conference call and webcast tomorrow at
8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can
access the live conference call by dialing 866-952-1907 (US) or
785-424-1826 (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 800-839-2459 (US) or 402-220-7218 (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 its lead program, 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 program will be delayed for regulatory or other
reasons; risk that the VMAT2 Phase III clinical program will fail
to demonstrate that NBI-98854 is safe and effective; risk that the
guidance provided by the FDA in the End-of-Phase II meeting may be
modified or may not lead to regulatory approval; risk that the
Company will be unable to file an IND for Tourette syndrome or
initiate clinical trials 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
report on Form 10-Q for the quarter ended March 31, 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 June 30,
|
|
Six Months
Ended June 30,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Revenues:
|
|
|
|
|
|
|
|
License
fees
|
$
-
|
|
$ 730
|
|
$
-
|
|
$ 1,460
|
|
|
|
|
|
|
|
|
Total
revenues
|
-
|
|
730
|
|
-
|
|
1,460
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
10,161
|
|
10,527
|
|
18,733
|
|
20,840
|
General and
administrative
|
4,200
|
|
3,370
|
|
8,353
|
|
6,762
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
14,361
|
|
13,897
|
|
27,086
|
|
27,602
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(14,361)
|
|
(13,167)
|
|
(27,086)
|
|
(26,142)
|
Other
income:
|
|
|
|
|
|
|
|
Gain (loss) on
sale/disposal of assets
|
5
|
|
19
|
|
(5)
|
|
32
|
Deferred gain on real
estate
|
805
|
|
781
|
|
1,609
|
|
1,563
|
Investment income,
net
|
167
|
|
121
|
|
256
|
|
224
|
Other income,
net
|
3
|
|
4
|
|
3
|
|
6
|
|
|
|
|
|
|
|
|
Total other
income
|
980
|
|
925
|
|
1,863
|
|
1,825
|
|
|
|
|
|
|
|
|
Net loss
|
$ (13,381)
|
|
$ (12,242)
|
|
$ (25,223)
|
|
$ (24,317)
|
|
|
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
$ (0.18)
|
|
$ (0.18)
|
|
$ (0.35)
|
|
$ (0.36)
|
|
|
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
75,879
|
|
66,799
|
|
73,085
|
|
66,700
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
|
|
|
June
30, 2014
|
|
December 31, 2013
|
Cash, cash equivalents
and short-term marketable securities
|
$
194,656
|
|
$
145,739
|
Other current
assets
|
2,919
|
|
2,723
|
|
|
|
|
Total current
assets
|
197,575
|
|
148,462
|
Property and
equipment, net
|
2,239
|
|
1,771
|
Long-term investments,
available for sale
|
65,282
|
|
-
|
Restricted
cash
|
4,443
|
|
4,443
|
|
|
|
|
Total
assets
|
$
269,539
|
|
$
154,676
|
|
|
|
|
|
|
|
|
Current
liabilities
|
$
12,053
|
|
$
11,699
|
Long-term
liabilities
|
20,641
|
|
22,567
|
Stockholders'
equity
|
236,845
|
|
120,410
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
269,539
|
|
$
154,676
|
|
|
|
|
SOURCE Neurocrine Biosciences, Inc.