SAN DIEGO, Aug. 3, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended June
30, 2016. For the second quarter of 2016, the Company
reported a net loss of $40.3 million,
or $0.46 loss per share, compared to
a net loss of $24.0 million, or
$0.28 loss per share, for the same
period in 2015. For the six months ended June 30, 2016, the Company reported a net loss of
$59.5 million, or $0.69 loss per share, as compared to a net loss
of $25.2 million, or $0.30 loss per share, for the first half of last
year.
The Company's balance sheet at June 30,
2016 reflected total assets of $429.8
million, including cash, cash equivalents, investments and
receivables of $416.5 million.
"During the first half of 2016 Neurocrine has been acutely
focused on two fronts: preparing our NDA for valbenazine in tardive
dyskinesia and pre-commercialization activities related to readying
valbenazine for commercial launch," said Kevin Gorman, Ph.D., President and Chief
Executive Officer of Neurocrine Biosciences. "Our R&D team has
been carefully compiling the extensive data from our 20 clinical
trials of valbenazine along with the preclinical and drug
manufacturing data into an NDA that we anticipate will
be submitted to the FDA soon. We have fully deployed our
medical affairs team and continue to build the capabilities to
introduce valbenazine to patients and a treatment community in need
of new medicines for a serious disorder."
Research and development expenses were $26.9 million during the second quarter of 2016
compared to $18.7 million for the
same period in 2015. For the six months ended June 30, 2016, research and development expenses
were $50.8 million, compared to
$35.3 million for the same period
last year. This increase was primarily due to higher external
clinical development expenses and associated internal costs related
to the Company's VMAT2 inhibitor, valbenazine, which is being
evaluated in both tardive dyskinesia and Tourette syndrome.
Additionally, expenses related to the Company's
preparation for the submission of a New Drug
Application for valbenazine in tardive dyskinesia accounted for a
significant portion of the increase in expenses for both quarter
over quarter and year over year.
General and administrative expenses increased from $6.6 million for the second quarter of 2015 to
$15.0 million for the second quarter
of 2016. For the six months ended June
30, 2016, general and administrative expenses were
$26.9 million, compared to
$12.1 million for the first half of
2015. The increase in general and administrative expense is
primarily due to pre-commercialization activities for valbenazine.
Personnel related costs increased by $4.1
million quarter over quarter and $8.1 year over year primarily due to the
expansion of sales and marketing and medical affairs personnel.
Approximately 50% of the increase in personnel related costs during
each of the periods is due to an increase in share-based
compensation costs. Additionally, professional costs related to
market research and other pre-commercial activities contributed to
the overall increase in general and administrative expenses.
Pipeline Highlights
Valbenazine Update
During the fourth quarter of 2015, the Company announced
positive efficacy 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 who underwent six weeks of
placebo controlled assessment. Subsequent to the initial six weeks
of treatment, subjects were eligible to continue in the Kinect 3
study for up to 42 weeks of additional valbenazine treatment. The
last subject is anticipated to complete dosing in August 2016.
In addition to the long-term extension phase of Kinect 3, during
the first quarter of 2016 the Company completed enrollment in a
separate one-year open-label safety study of valbenazine, Kinect 4,
to support the anticipated 2016 submission of a New Drug
Application of valbenazine in tardive dyskinesia.
The Company also recently initiated a valbenazine roll-over
study for those patients who complete the one year of dosing in
either the Kinect 3 or Kinect 4 studies. This roll-over study is
designed to permit open-label access to valbenazine for up to an
additional 72 weeks of treatment.
During the second quarter of 2016, the Company presented eight
valbenazine abstracts at three major medical meetings. Valbenazine
data from the Kinect clinical trials were presented at podium and
plenary sessions at the American Academy of Neurology Annual
Meeting in April. In addition, four valbenazine scientific
abstracts were presented at the American Psychiatric Association
Annual Meeting in May. Data from Kinect 3 was also shared at the
20th International Congress of Parkinson's Disease and
Movement Disorders in Berlin
during the month of June.
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 Company has two ongoing placebo-controlled 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 6.
Data from both of these Tourette studies is expected around
year-end 2016.
Additionally, the Company has recently launched an open-label,
fixed-dose study of valbenazine in up to 180 subjects with Tourette
syndrome. This study is designed to enroll up to 90 children and
adolescents and up to 90 adults who have completed either of the
two placebo-controlled Tourette clinical trials: T-Force GREEN or
T-Forward. This Phase II study will assess the long-term safety and
tolerability of valbenazine in children and adults with
Tourette's.
Elagolix Update
During the first quarter of 2016, AbbVie 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. The Company expects the
initial top line efficacy data from the uterine fibroid Phase III
program in 2017.
Essential Tremor Program (NBI-640756) Update
NBI-640756 for patients with essential tremor was discovered in
the Neurocrine laboratories. The Company has successfully completed
an initial Phase I 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.
Based on the results of this initial study, the Company has
initiated a second Phase I, single site, randomized, double-blind,
placebo-controlled, multiple-dose, sequential dose-escalation study
to evaluate the safety, tolerability and pharmacokinetics of
NBI-640756 in up to 30 healthy volunteers over a week of continuous
dosing. The study is being conducted in multiple sequential cohorts
of ten subjects per cohort; data from this second Phase I study is
expected later in 2016. The data from this study, in conjunction
with the single dose Phase I study and preclinical studies, will be
evaluated and utilized in the design of the anticipated Phase II
program for NBI-640756.
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 888-632-3384 (US) or
785-424-1675 (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 800-839-1246 (US)
or 402-220-0464 (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,
2015 and quarterly report on Form 10-Q for the quarter ended
March 31, 2016. 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
June 30,
|
|
Six Months
Ended
June 30,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
License fees and
milestones
|
$
-
|
|
$
-
|
|
$ 15,000
|
|
$ 19,769
|
Total
revenues
|
-
|
|
-
|
|
15,000
|
|
19,769
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
26,863
|
|
18,719
|
|
50,766
|
|
35,294
|
General and
administrative
|
14,965
|
|
6,603
|
|
26,919
|
|
12,085
|
Total operating
expenses
|
41,828
|
|
25,322
|
|
77,685
|
|
47,379
|
Loss from
operations
|
(41,828)
|
|
(25,322)
|
|
(62,685)
|
|
(27,610)
|
Other
income:
|
|
|
|
|
|
|
|
Gain on sale/disposal
of
assets
|
14
|
|
-
|
|
17
|
|
9
|
Deferred gain on real
estate
|
854
|
|
829
|
|
1,707
|
|
1,659
|
Investment income,
net
|
680
|
|
506
|
|
1,417
|
|
763
|
Total other
income
|
1,548
|
|
1,335
|
|
3,141
|
|
2,431
|
Net loss
|
$ (40,280)
|
|
$ (23,987)
|
|
$(59,544)
|
|
$ (25,179)
|
Net loss per common
share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
(0.46)
|
|
$
(0.28)
|
|
$
(0.69)
|
|
$
(0.30)
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
86,694
|
|
85,518
|
|
86,595
|
|
82,947
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC.
Condensed
Consolidated Balance Sheets
(in
thousands)
|
|
|
|
|
|
|
|
|
|
June 30,
2016
|
|
December
31, 2015
|
|
|
|
(unaudited)
|
Cash, cash
equivalents and short-term marketable securities
|
$387,398
|
|
$ 379,191
|
Other current
assets
|
4,568
|
|
4,883
|
Total current assets
|
391,966
|
|
384,074
|
|
|
|
|
|
|
Property and
equipment, net
|
5,811
|
|
3,432
|
Long-term
investments
|
27,178
|
|
82,488
|
Restricted
cash
|
4,883
|
|
4,791
|
Total
assets
|
$429,838
|
|
$474,785
|
|
|
|
|
|
|
Current
liabilities
|
$26,899
|
|
$ 25,715
|
Long-term
liabilities
|
21,901
|
|
24,616
|
Stockholders'
equity
|
381,038
|
|
424,454
|
Total
liabilities and stockholders' equity
|
$429,838
|
|
$474,785
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-second-quarter-2016-results-300308595.html
SOURCE Neurocrine Biosciences, Inc.