SAN DIEGO, Feb. 11, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter and year ended December 31, 2015.
For the fourth quarter of 2015, the Company reported a net loss
of $29.3 million, or $0.34 loss per share, compared to a net loss of
$19.4 million, or $0.26 loss per share for the same period in 2014.
For the year ended December 31, 2015,
the Company reported a net loss of $88.9
million, or $1.05 loss per
share, as compared to a net loss of $60.5
million, or $0.81 loss per
share for 2014. The increase in net loss for the fourth quarter and
full year results primarily from increased research and development
expenses in connection with the Company's advancing clinical stage
pipeline, valbenazine pre-commercialization activities for tardive
dyskinesia and higher share-based compensation expense as detailed
below.
The Company's balance sheet at December
31, 2015 reflected total assets of $474.8 million, including cash, investments and
receivables of $464.3 million
compared with balances at December 31,
2014 of $243.0 million and
$232.6 million, respectively.
"We begin 2016 with positive top-line data from our partner
AbbVie in the second Phase III study of elagolix in endometriosis
coupled with the start of two Phase III studies of elagolix in
uterine fibroids," said Kevin
Gorman, Ph.D., President and Chief Executive Officer of
Neurocrine Biosciences. "Recently we reported a highly positive
Phase III study of valbenazine in tardive dyskinesia and now look
forward to filing our valbenazine NDA for tardive dyskinesia with
the FDA this year. We have also initiated two Phase II studies of
valbenazine in Tourette syndrome with data on these expected around
the end of the year. Additionally, we have NBI-640756, our drug
candidate for essential tremor, in the clinic and we look to add
yet another new compound to our clinical pipeline later this
year."
Research and development expenses were $21.8 million during the fourth quarter of 2015,
compared to $15.5 million for the
same period in 2014. For the year ended December 31, 2015, research and development
expenses were $81.5 million, compared
to $46.4 million for all of 2014. The
increase in research and development expense 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 $7.9 million from 2014 levels primarily due to
performance-based restricted stock units.
General and administrative expenses increased from $5.0 million for the fourth quarter of 2014 to
$8.9 million for the fourth quarter
of 2015. For the year ended December 31,
2015 general and administrative expenses were $32.5 million, compared to $18.0 million for the prior year. The increase in
general and administrative expense is primarily due to higher
personnel related costs, including a $10.1
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.
2016 Financial Guidance
The Company expects to have a cash burn of approximately
$135 million to $145 million in 2016.
The increase in cash burn from 2015 is primarily due to preparing
for commercialization of valbenazine in tardive dyskinesia coupled
with expansion and progression of the clinical pipeline.
Revenues for 2016 are expected to be approximately
$15 million. Expenses for 2016 should
approximate $185 million to $195
million. The anticipated expenses include an estimated
$30 million for share-based
compensation expense.
Pipeline Highlights
Valbenazine Update
During the fourth quarter of 2015, the Company announced
positive top-line results from the Kinect 3 study, a Phase III
trial that included moderate to severe tardive dyskinesia in
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
(valbenazine), or once-daily 80mg of valbenazine 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 valbenazine
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 valbenazine 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 valbenazine, Kinect 4, to support the anticipated 2016
filing of a New Drug Application of valbenazine in tardive
dyskinesia. As announced previously, Neurocrine has received
Breakthrough Therapy Designation from the FDA for valbenazine in
the treatment of tardive dyskinesia.
The Company is also exploring valbenazine in Tourette syndrome.
The initial Tourette's clinical trial, the T-Force study, was an
open-label, multi-dose, two-week evaluation of 28 subjects with
Tourette syndrome. Children and adolescents enrolled in the trial
are receiving a once-daily dose of valbenazine during a two-week
treatment period to assess both the safety and tolerability of
valbenazine. Valbenazine was generally safe and well tolerated. The
Yale Global Tic Severity Scale was also assessed and after two
weeks of treatment showed a mean reduction of 31% from baseline
scores, with over half of the subjects considered clinical
responders.
The Company recently announced the initiation of two Phase II
Tourette syndrome studies evaluating valbenazine in adults and
pediatrics, the T-Forward study and T-Force GREEN study,
respectively.
The T-Forward 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 valbenazine
during an eight-week treatment period to assess the safety,
tolerability and efficacy of valbenazine in adult 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.
The T-Force GREEN study is a randomized, double-blind,
placebo-controlled, multi-dose, parallel group, study of up to 90
children and adolescents. Subjects will receive once-daily dosing
of valbenazine during a six-week treatment period to assess the
safety, tolerability and efficacy of valbenazine in pediatric
Tourette patients. The primary endpoint of this study is the change
from baseline of the Yale Global Tic Severity Scale between placebo
and active treatment groups at the end of week six.
Data from both of these Tourette studies is expected around
year-end 2016.
Elagolix Update
AbbVie recently announced positive top-line results from the
second of two Phase III clinical trials, the Solstice Study, a
multinational study designed to evaluate the efficacy and safety of
elagolix in 815 premenopausal women with endometriosis. The
top-line results from this trial were consistent with those of the
initial Phase III clinical trial, the Violet Petal Study, where
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 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 Solstice study was consistent with observations
from prior studies. Among the most common adverse events (AEs) were
hot flush, headache, and nausea. While most AEs were similar across
treatment groups some, such as hot flush and bone mineral density
loss, were dose-dependent. AbbVie is targeting a 2017 New Drug
Application filing with the FDA for elagolix in endometriosis.
In early 2016, AbbVie announced the initiation of the Phase III
uterine fibroids program consisting of two replicate randomized,
parallel, double-blind, placebo-controlled clinical trials
evaluating elagolix alone or in combination with add-back therapy
in women with heavy uterine bleeding associated with uterine
fibroids. The studies are expected to enroll approximately 400
subjects each for an initial six-month placebo-controlled dosing
period. At the end of the six-months of placebo-controlled
evaluation, subjects are eligible to enter an additional six-month
safety extension study. The primary efficacy endpoint of the study
is an assessment of the change in menstrual blood loss utilizing
the alkaline hematin method comparing baseline to month six.
Additional secondary efficacy endpoints will be evaluated including
assessing the change in fibroid volume and hemoglobin. Bone mineral
density will be assessed via DXA scan at baseline, the conclusion
of dosing, and six months post-dosing.
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. Bone mineral density loss associated with elagolix
alone was attenuated when elagolix was co-administered with
add-back therapy.
Essential Tremor Program (NBI-640756) Update
NBI-640756 for patients with essential tremor was discovered in
the Neurocrine laboratories. The Company has initiated a single
site, randomized, double-blind, placebo-controlled, sequential
dose-escalation, pharmacokinetic study assessing the safety and
tolerability of a single dose of NBI-640756 in up to 32 healthy
volunteers. The study is being conducted in multiple
sequential cohorts of eight subjects per cohort. Top-line data from
this Phase I study is expected in the first-half of 2016.
Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine will hold a live conference call and webcast today at
4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access
the live conference call by dialing 866-952-7534 (US) or
785-424-1835 (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 800-677-6124 (US)
or 402-220-0664 (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 valbenazine, 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 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 associated with
the Company's dependence on AbbVie for the development and
commercialization of elagolix; 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 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
third parties for development, manufacturing and marketing
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 reports on Form 10-Q for the quarters
ended March 31, 2015, June 30, 2015 and September 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
December 31,
|
Year Ended
December 31,
|
|
2015
|
2014
|
2015
|
2014
|
Revenues:
|
|
|
|
|
Milestones and license
fees
|
$
-
|
$
-
|
$ 19,769
|
$
-
|
|
|
|
|
|
Total
revenues
|
-
|
-
|
19,769
|
-
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
21,809
|
15,498
|
81,491
|
46,425
|
General and
administrative
|
8,939
|
4,970
|
32,480
|
17,986
|
|
|
|
|
|
Total operating
expenses
|
30,748
|
20,468
|
113,971
|
64,411
|
|
|
|
|
|
Loss from
operations
|
(30,748)
|
(20,468)
|
(94,202)
|
(64,411)
|
Other
income:
|
|
|
|
|
(Loss) gain on
sale/disposal of assets
|
-
|
-
|
9
|
(4)
|
Deferred gain on real
estate
|
838
|
812
|
3,325
|
3,226
|
Investment income,
net
|
584
|
197
|
1,928
|
629
|
Other income,
net
|
11
|
15
|
11
|
18
|
|
|
|
|
|
Total other
income
|
1,433
|
1,024
|
5,273
|
3,869
|
|
|
|
|
|
Net loss
|
$ (29,315)
|
$ (19,444)
|
$ (88,929)
|
$ (60,452)
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
Basic and
Diluted
|
$ (0.34)
|
$ (0.26)
|
$ (1.05)
|
$ (0.81)
|
|
|
|
|
|
Shares used in the
calculation of net (loss) income per common share:
|
|
|
|
|
Basic and
Diluted
|
86,184
|
76,139
|
84,496
|
74,577
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
December 31,
2015
|
December 31,
2014
|
Cash, cash equivalents
and short-term marketable securities
|
$ 379,191
|
$ 193,809
|
Other current
assets
|
4,883
|
4,394
|
|
|
|
Total current
assets
|
384,074
|
198,203
|
Property and
equipment, net
|
3,432
|
2,507
|
Long-term
investments
|
82,488
|
37,492
|
Restricted
cash
|
4,791
|
4,831
|
|
|
|
Total
assets
|
$ 474,785
|
$ 243,033
|
|
|
|
|
|
|
Current
liabilities
|
$
25,715
|
$
15,664
|
Long-term
liabilities
|
24,616
|
18,670
|
Stockholders'
equity
|
424,454
|
208,699
|
|
|
|
Total liabilities and
stockholders' equity
|
$ 474,785
|
$ 243,033
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-year-end-2015-results-and-provides-investor-update-for-2016-300219066.html
SOURCE Neurocrine Biosciences, Inc.