SAN DIEGO, May 5, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended March 31,
2016. For the first quarter of 2016, the Company reported a
net loss of $19.3 million, or
$0.22 loss per share, compared to a
net loss of $1.2 million, or
$0.01 loss per share, for the same
period in 2015.
The Company's balance sheet at March 31,
2016 reflected cash, cash equivalents, investments and
receivables of $448.6 million
compared to $464.3 million at
December 31, 2015.
"2015 was a very successful year for Neurocrine and we have
carried this momentum into the first quarter of 2016 beginning with
positive top-line data from the second Phase III study of elagolix
in endometriosis, the initiation of two Phase III studies of
elagolix in uterine fibroids, the start of our Phase II T-Force
GREEN study of valbenazine in children and adolescents with
Tourette syndrome, as well as the acceptance of seven valbenazine
abstracts at the American Academy of Neurology and American
Psychiatric Association Annual Meetings" said Kevin Gorman, Ph.D., President and Chief
Executive Officer of Neurocrine Biosciences. "Our focus for the
coming months is to continue to execute across all aspects of our
business; advancing compounds from research into the clinic,
executing on clinical trials, filing the valbenazine NDA, and
interacting with providers and payers as we prepare for the
commercial launch of valbenazine for tardive dyskinesia upon FDA
approval."
The $15.0 million of revenue for
the first quarter of 2016 represents a milestone payment from
AbbVie related to the commencement of Phase III studies of elagolix
in uterine fibroids. The $19.8
million of revenue for the first quarter of 2015 represents
recognized revenue in the form of license fees from the NBI-98854
(valbenazine) collaboration and license agreement with Mitsubishi
Tanabe.
Research and development expenses increased to $23.9 million during the first quarter of 2016
from $16.6 million during the same
period in 2015. 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 of the New Drug Application for valbenazine in tardive
dyskinesia accounted for a portion of the increase in expenses
quarter over quarter.
General and administrative expenses increased from $5.5 million in the first quarter of 2015 to
$12.0 million for the first quarter
of 2016, primarily due to pre-commercialization activities for
valbenazine. Personnel related costs increased by $3.9 million quarter over quarter primarily due
to the expansion of sales and marketing and medical affairs
personnel. This increase in personnel related costs includes a
$2.4 million increase in share-based
compensation expense. Additionally, a significant increase in other
pre-commercialization activities contributed to the overall growth
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 an additional 42 week open-label safety assessment. The
open-label safety evaluation is anticipated to complete dosing in
mid-2016.
In addition to the ongoing safety assessment 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 filing 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.
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 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 6.
Data from both of these Tourette studies is expected around
year-end 2016.
The Company has submitted and had accepted seven valbenazine
abstracts at two major medical conferences during the second
quarter. Valbenazine data from all three 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 submitted and accepted for
the American Psychiatric Association Annual Meeting in May.
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.
Essential Tremor Program (NBI-640756) Update
NBI-640756 for patients with essential tremor was discovered in
the Neurocrine laboratories. The Company has completed dosing in 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 was conducted in multiple sequential
cohorts of eight subjects per cohort. Data from this initial Phase
I study is expected in the second 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 877-876-9174 (US) or
785-424-1669 (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 800-695-2533 (US)
or 402-530-9029 (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. 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)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
|
2016
|
|
2015
|
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
License fees and
milestones
|
$ 15,000
|
|
$ 19,769
|
Total
revenues
|
15,000
|
|
19,769
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
Research and
development
|
23,903
|
|
16,575
|
General and
administrative
|
11,954
|
|
5,482
|
Total
operating expenses
|
35,857
|
|
22,057
|
|
|
|
|
|
|
Loss from
operations
|
(20,857)
|
|
(2,288)
|
|
|
|
|
|
|
Other
income:
|
|
|
|
Interest and other
income
|
737
|
|
257
|
Gain on sale of
assets
|
856
|
|
839
|
Total other
income
|
1,593
|
|
1,096
|
|
|
|
|
Net loss
|
$ (19,264)
|
|
$ (1,192)
|
Net loss per common
share:
|
|
|
|
Basic and
Diluted
|
$ (0.22)
|
|
$ (0.01)
|
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
Basic and
Diluted
|
86,497
|
|
80,349
|
|
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
|
2016
|
|
2015
|
|
|
|
(unaudited)
|
Cash, cash
equivalents and short-term marketable securities
|
$381,524
|
|
$ 379,191
|
Other current
assets
|
19,460
|
|
4,883
|
Total current
assets
|
400,984
|
|
384,074
|
|
|
|
|
|
|
Property and
equipment, net
|
3,897
|
|
3,432
|
Long-term
investments
|
49,460
|
|
82,488
|
Restricted
cash
|
4,991
|
|
4,791
|
Total
assets
|
$459,332
|
|
$474,785
|
|
|
|
|
|
|
Current
liabilities
|
$23,276
|
|
$ 25,715
|
Long-term
liabilities
|
23,097
|
|
24,616
|
Stockholders'
equity
|
412,959
|
|
424,454
|
Total liabilities and
stockholders' equity
|
$459,332
|
|
$474,785
|
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SOURCE Neurocrine Biosciences, Inc.