SAN DIEGO, Oct. 29, 2015 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended September 30,
2015. For the third quarter of 2015, the Company
reported a net loss of $34.4 million,
or $0.40 loss per share, compared to
a net loss of $15.9 million, or
$0.21 loss per share, for the same
period in 2014. For the nine months ended September 30, 2015, the Company reported a net
loss of $59.6 million, or
$0.71 loss per share, as compared to
net loss of $41.1 million, or
$0.56 loss per share, for the first
nine months of last year.
The Company's balance sheet at September
30, 2015 reflected total assets of $492.4 million, including cash, cash equivalents,
investments and receivables of $481.7
million.
"We have made significant progress over the past three months
across our clinical programs, including the successful Kinect 3
Phase III study of NBI-98854 in tardive dyskinesia, our partner
AbbVie reported positive results in the Phase IIb study of elagolix
in uterine fibroids and is moving forward into Phase III
development for uterine fibroids, and also the recent initiation of
our Phase II study of NBI-98854 in adults with Tourette syndrome,"
said Kevin Gorman, President and
Chief Executive Officer of Neurocrine Biosciences. "We look forward
to the readout from our Phase Ib study of NBI-98854 in children and
adolescents with Tourette's in December of this year."
Research and development expenses were $24.4 million during the third quarter of 2015
compared to $12.2 million for the
same period in 2014. For the nine months ended
September 30, 2015, research and
development expenses were $59.7
million, compared to $30.9
million for the same period last year. This increase was due
to higher external clinical development expenses and associated
internal costs related to NBI-98854, which initiated Phase III
development in the second half of 2014, as well as preparations for
a potential New Drug Application filing in 2016. Additionally,
year-to-date share-based compensation expense increased by
$6.6 million from 2014 levels
primarily due to performance-based restricted stock units.
General and administrative expenses increased from $4.7 million for the third quarter of 2014 to
$11.5 million for the third quarter
of 2015. For the nine months ended September 30, 2015, general and administrative
expenses were $23.5 million, compared
to $13.0 million for the first nine
months of 2014. The increase in general and administrative
expense is primarily due to higher personnel related costs,
including a $7.7 million increase in
year-to-date share-based compensation expense primarily due to
performance-based restricted stock units. Additionally,
professional costs related to market research and
pre-commercialization activities contributed to the overall
increase in general and administrative expenses.
Updated 2015 Financial Guidance
The Company expects to end 2015 with in excess of $450 million in cash, investments and
receivables. The gross cash burn from operations, prior to any
revenues, remains unchanged at approximately $85 million for 2015. Total expenses for 2015 are
expected to be approximately $110 to $115
million. The previous financial guidance for expenses during
2015 ranged from of $106 to $111
million. Based on the positive results of the Kinect 3 study
of NBI-98854 in tardive dyskinesia, the Company is accelerating
certain activities originally planned for 2016 into the fourth
quarter of 2015.
Pipeline Highlights
VMAT2 Update
Earlier this month, the Company announced positive top-line
results from the Kinect 3 study, a Phase III trial that included
moderate to severe tardive dyskinesia patients with underlying
schizophrenia, schizoaffective disorder, bipolar or major
depressive disorder. The Kinect 3 study randomized 234 subjects 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 primary efficacy
endpoint was the change-from-baseline in the Abnormal Involuntary
Movement Scale (AIMS) at Week 6 in the 80mg once-daily dosing group
compared to placebo as assessed by central blinded video raters.
The AIMS ratings at Week 6 for the 80mg once-daily NBI-98854
intention-to-treat (ITT) population was reduced 3.1 points
(Least-Squares Mean) more than placebo (p<0.0001). During the
six-week placebo-controlled treatment period NBI-98854 was
generally well tolerated. The frequency of adverse events was
similar among all treatment groups and treatment emergent adverse
effects were consistent with those of prior studies.
In addition to the ongoing safety assessment of Kinect 3, the
Company is also conducting a separate one-year open-label safety
study of NBI-98854, Kinect 4, to support the anticipated 2016
filing of a New Drug Application in tardive dyskinesia.
As announced previously, Neurocrine has received Breakthrough
Therapy Designation from the FDA for NBI-98854 in the treatment of
tardive dyskinesia.
The Company is also exploring NBI-98854 in Tourette syndrome.
The initial Tourette's clinical trial, the T-Force study, is an
open-label, multi-dose, two-week evaluation of up to 36 subjects
with Tourette syndrome. Children and adolescents enrolled in the
trial are receiving a once-daily dose of NBI-98854 during a
two-week treatment period to assess both the safety and
tolerability of NBI-98854. Additionally, the Yale Global Tic
Severity Scale and the Premonitory Urge for Tics Scale are being
utilized during the study to assess the impact of NBI-98854 on the
patients' Tourette symptoms. Data from the T-Force study is
expected later in 2015.
The Company recently announced the initiation of a second
Tourette syndrome study evaluating NBI-98854 in adults, the
T-Forward Study. This study is a randomized, double-blind,
placebo-controlled, multi-dose, parallel group, study of up to 90
adults. Subjects will receive once-daily dosing of NBI-98854 during
an eight-week treatment period to assess the safety, tolerability
and efficacy of NBI-98854 in Tourette patients. The primary
endpoint of this study is a change from baseline of placebo vs.
active scores utilizing the Yale Global Tic Severity Scale at the
end of Week 8. Data from this study is expected later in 2016.
Elagolix Update
In September 2015, AbbVie
announced positive top-line results from a Phase IIb clinical trial
in women with heavy menstrual bleeding associated with uterine
fibroids. The trial evaluated the safety and efficacy of elagolix
alone or in combination with add-back therapy compared to placebo.
Preliminary results showed that all of the elagolix treatment arms,
with and without add-back therapy, reduced heavy menstrual bleeding
as compared to placebo (p<0.001). Among the most common adverse
AEs were hot flush, headache, nausea, and vomiting. Some AEs such
as hot flush were more frequent in the elagolix only treatment arms
as compared to the placebo and elagolix with add-back therapy
treatment arms. Reduction in bone mineral density associated with
elagolix alone was attenuated when elagolix was co-administered
with add-back therapy. The elagolix uterine fibroids Phase III
program is targeted to begin the first quarter of 2016 and will
include two replicate, pivotal, six-month efficacy and safety
studies followed by a six-month safety and efficacy extension
study.
In early 2015, AbbVie announced positive top-line results from
the first of two ongoing Phase III clinical trials, the Violet
Petal Study, designed to evaluate the efficacy and safety of
elagolix in premenopausal women with endometriosis. Results from
the trial show that after six months of treatment, both doses of
elagolix (150 mg once daily and 200 mg twice daily) met the study's
co-primary endpoints (p<0.001) of reducing scores of
non-menstrual pelvic pain and menstrual pain (or dysmenorrhea)
associated with endometriosis at month three, as well as month six,
as measured by the Daily Assessment of Endometriosis Pain scale.
The observed safety profile of elagolix in the Violet Petal Study
was consistent with observations from prior studies. Among the most
common adverse events (AEs) were hot flush, headache, nausea and
fatigue. While most AEs were similar across treatment groups some,
such as hot flush and bone mineral density loss, were
dose-dependent. AbbVie recently completed the six month extension
of the initial elagolix Phase III endometriosis study and disclosed
that the efficacy and safety at month twelve were consistent with
the efficacy and safety findings seen at month six.
AbbVie is 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. Top-line efficacy data from this study is
expected in the first quarter of 2016.
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 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 (858)
617-7600. A replay of the conference call will be available
approximately one hour after the conclusion of the call by dialing
800-839-5127 (US) or 402-220-2692 (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 NBI-98854, a 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 business and finances in general, as well as
risks and uncertainties associated with the Company's R & D
pipeline and the Company overall. Specifically, the risks and
uncertainties the Company faces include risks that clinical
development activities may not be completed on time or at all;
risks that clinical development activities may be delayed for
regulatory or other reasons, may not be successful or replicate
previous clinical trial results, may fail to demonstrate that our
product candidates are safe and effective, or may not be predictive
of real-world results or of results in subsequent clinical trials;
risks that regulatory submissions may not occur or be submitted in
a timely manner; risks that the Company's product candidates may
not obtain regulatory approval or that the U.S. Food and Drug
Administration or regulatory authorities outside the U.S. may make
adverse decisions regarding the Company's product candidates; risks
that the Company's product candidates may be precluded from
commercialization by the proprietary rights of third parties, or
have unintended side effects, adverse reactions or incidents of
misuse; risks associated with the Company's dependence on AbbVie
for elagolix development and commercialization and dependence on
other third parties for development, manufacturing and marketing
and sales activities; risks that the Company's research programs
will not identify pre-clinical candidates for further development;
risks that the Company will be unable to raise additional funding
required to complete development of all of its product candidates;
risk and uncertainties relating to competitive products and
technological changes that may limit demand for the Company's
products; and other risks described in the Company's annual report
on Form 10-K for the year ended December 31,
2014 and quarterly report on Form 10-Q for the quarter ended
March 31, 2015 and June 30, 2015. Neurocrine disclaims any
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,
|
|
2015
|
2014
|
2015
|
2014
|
Revenues:
|
|
|
|
|
License
fees
|
$
-
|
$
-
|
$ 19,769
|
$
-
|
|
|
|
|
|
Total
revenues
|
-
|
-
|
19,769
|
-
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
24,388
|
12,194
|
59,682
|
30,927
|
General and
administrative
|
11,456
|
4,663
|
23,541
|
13,016
|
|
|
|
|
|
Total operating
expenses
|
35,844
|
16,857
|
83,223
|
43,943
|
|
|
|
|
|
Loss from
operations
|
(35,844)
|
(16,857)
|
(63,454)
|
(43,943)
|
Other
income:
|
|
|
|
|
Gain (loss) on
sale/disposal of assets
|
-
|
1
|
9
|
(4)
|
Deferred gain on real
estate
|
828
|
805
|
2,487
|
2,414
|
Investment income,
net
|
581
|
176
|
1,344
|
432
|
Other income,
net
|
-
|
-
|
-
|
3
|
|
|
|
|
|
Total other
income
|
1,409
|
982
|
3,840
|
2,845
|
|
|
|
|
|
Net loss
|
$ (34,435)
|
$(15,875)
|
$ (59,614)
|
$ (41,098)
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
Basic and
diluted
|
$ (0.40)
|
$ (0.21)
|
$ (0.71)
|
$ (0.56)
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
Basic and
diluted
|
85,856
|
75,948
|
83,927
|
74,050
|
|
|
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (in
thousands) (unaudited)
|
|
|
|
|
September
30, 2015
|
December
31,
2014
|
Cash, cash equivalents
and short-term marketable securities
|
$
376,845
|
$
193,809
|
Other current
assets
|
5,940
|
4,394
|
|
|
|
Total current
assets
|
382,785
|
198,203
|
Property and
equipment, net
|
2,874
|
2,507
|
Long-term investments,
available for sale
|
101,986
|
37,492
|
Restricted
cash
|
4,791
|
4,831
|
|
|
|
Total
assets
|
$
492,436
|
$
243,033
|
|
|
|
|
|
|
Current
liabilities
|
$
19,822
|
$
15,664
|
Long-term
liabilities
|
25,671
|
18,670
|
Stockholders'
equity
|
446,943
|
208,699
|
|
|
|
Total liabilities and
stockholders' equity
|
$
492,436
|
$
243,033
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-third-quarter-2015-results-300168966.html
SOURCE Neurocrine Biosciences, Inc.