SAN DIEGO, Nov. 2, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended September 30,
2016. For the third quarter of 2016, the Company
reported a net loss of $36.9 million,
or $0.43 loss per share, compared to
a net loss of $34.4 million, or
$0.40 loss per share, for the same
period in 2015. For the nine months ended September 30, 2016, the Company reported a net
loss of $96.4 million, or
$1.11 loss per share, as compared to
net loss of $59.6 million, or
$0.71 loss per share, for the first
nine months of last year.
The Company's balance sheet at September
30, 2016 reflected total assets of $399.2 million, including cash, cash equivalents,
investments and receivables of $385.3
million.
"Our NDA for INGREZZATM in tardive dyskinesia was
recently accepted by the FDA for Priority Review and we look
forward to continuing our work with the FDA to potentially bring
this important treatment option to patients and physicians," said
Kevin Gorman, President and Chief
Executive Officer of Neurocrine Biosciences. "In addition, our
partner AbbVie presented Phase III data for elagolix in
endometriosis at the 72nd American Society for
Reproductive Medicine Scientific Congress & Expo. The results
from the Phase III Violet Petal and Solstice clinical trials
demonstrate that elagolix has the potential to be an important
treatment for women suffering from endometriosis."
Research and development expenses were $20.9 million during the third quarter of 2016
compared to $24.4 million for the
same period in 2015. Quarterly external development expense
decreased by approximately $2.5
million from 2015 to 2016 primarily due to the completion of
certain INGREZZA (valbenazine) manufacturing activities and the
conclusion of the Kinect 3 clinical trial in 2016. Additionally,
share-based compensation expense for research and development was
$3.6 million lower during the third
quarter of 2016 compared to the third quarter of 2015. The decrease
in share-based compensation expense is primarily due to certain
performance-based restricted stock units which met the criteria for
expensing during the third quarter of 2015.
For the nine months ended September 30,
2016, research and development expenses were $71.7 million, compared to $59.7 million for the same period last year. This
increase was primarily due to expenses related to the Company's
compilation and submission of the New Drug Application (NDA) for
INGREZZA in tardive dyskinesia. Additionally, external clinical
development expenses related to INGREZZA, which is being evaluated
in both tardive dyskinesia and Tourette syndrome, accounted for
$4.0 million of the increase in
year-to-date expenses.
General and administrative expenses increased from $11.5 million for the third quarter of 2015 to
$17.5 million for the third quarter
of 2016. For the nine months ended September 30, 2016, general and administrative
expenses were $44.4 million, compared
to $23.5 million for the first nine
months of 2015. The overall increase in general and administrative
expense is primarily due to pre-commercialization activities for
INGREZZA. General and administrative share-based compensation
expense was $4.0 million lower during
the third quarter of 2016 compared to the third quarter of 2015.
The decrease in quarterly share-based compensation expense is
primarily due to certain performance-based restricted stock units
which met the criteria for expensing during the third quarter of
2015. Other personnel related costs increased by $3.8 million quarter over quarter, and by
$7.6 million for the first nine
months of 2015 compared to the first nine months of 2016 primarily
due to the expansion of sales and marketing and medical affairs
personnel. Additionally, professional costs related to market
research and other pre-commercial activities increased by
$5.4 million quarter over quarter and
by $11.9 million for the first nine
months of 2016 compared to the same period in 2015.
Updated 2016 Financial Guidance
The Company expects to end 2016 with approximately $340 million in cash, investments and
receivables. The previous financial guidance was to end 2016 with
approximately $320 million in cash,
investments and receivables. Total expenses for 2016 are expected
to be approximately $160 to $170
million. The previous financial guidance for 2016 expenses
ranged from $185 to $195 million. The
lower than anticipated cost of preclinical and clinical development
as well as lower headcount contributed to this reduction in
estimated 2016 expenses.
Pipeline Highlights
INGREZZA (valbenazine) Update
The NDA for INGREZZA for the treatment of tardive dyskinesia was
submitted to the U.S. Food and Drug Administration (FDA) during the
third quarter of 2016. The NDA was accepted for Priority
Review by the FDA and received a Prescription Drug User Fee Act
(PDUFA) target action date of April 11,
2017.
During the third quarter of 2016, the Company completed 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
INGREZZA treatment. The Company had previously announced positive
efficacy results from the six-week placebo-controlled portion of
the Kinect 3 study during the fourth quarter of 2015.
The Company is currently conducting a separate one-year
open-label safety study of INGREZZA, Kinect 4. This study is fully
enrolled and expected to complete its one year of dosing in early
2017.
The Company is also supporting an INGREZZA 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 INGREZZA for up to an additional 72
weeks of treatment.
INGREZZA is also being investigated in Tourette syndrome through
two ongoing placebo-controlled Phase II Tourette syndrome studies
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 that has
completed enrollment of 124 adults with moderate to severe
Tourette's. The adult Tourette patients are receiving once-daily
dosing of INGREZZA or placebo during the eight-week treatment
period to assess the safety, tolerability and efficacy of INGREZZA.
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. Top-line data from this study is
expected in January 2017.
The T-Force GREEN study is a randomized, double-blind,
placebo-controlled, multi-dose, parallel group study of up to 90
children and adolescents. Pediatric Tourette subjects receive
once-daily dosing of INGREZZA or placebo during a six-week
treatment period to assess the safety, tolerability and efficacy of
INGREZZA. 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. Top-line data from
this study is expected in early 2017.
Additionally, the Company has also launched an open-label,
fixed-dose study of INGREZZA 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 INGREZZA in children and adults with
Tourette's.
Elagolix Update
In October, AbbVie presented multiple scientific abstracts at
the 72nd American Society for Reproductive
Medicine Scientific Congress & Expo in Salt Lake City. The posters and oral
presentations highlighted positive primary and secondary efficacy
endpoint data from the Phase III studies of elagolix in
premenopausal women who suffer from endometriosis as well as
research on the economic burden of endometriosis and
endometriosis-related surgery in women in the United
States:
- Elagolix, An Oral Gonadotropin-Releasing Hormone (GnRH)
Antagonist, For The Management Of Endometriosis-Associated Pain:
Safety And Efficacy Results From Two Double-Blind, Randomized,
Placebo-Controlled Studies; Taylor H, et al.
- Use Of Elagolix For The Management Of
Endometriosis-Associated Pain: Secondary Efficacy Results From Two
Randomized, Placebo-Controlled Studies; Surrey, et
al.
- The Effect of Elagolix On Bone Mineral Density: Safety
Results From Two Randomized, Placebo-Controlled Studies In Women
With Endometriosis-Associated Pain; Archer et
al.
- Incremental Costs of Healthcare and Work Loss Attributed to
Endometriosis in a Cohort of Commercially Insured Women;
Soliman et al.
- Incidence of Comorbidities Among Women with Endometriosis: A
Retrospective Matched Cohort Study; Soliman et
al.
- The Effect Of Elagolix On The Endometrium: Safety Results
From Two Randomized, Placebo-Controlled Studies In Women With
Endometriosis-Associated Pain; Diamond et
al.
- The Impact of Elagolix on Quality of Life in Women with
Endometriosis-Associated Pain: Results From Two Randomized,
Placebo-Controlled Studies Using the Endometriosis Health Profile
Questionnaire; Taylor H et al.
- Direct and Indirect Costs Associated with
Endometriosis-Related Surgery Among Employed Women in the
US; Soliman et al.
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 NDA 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
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
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 in subjects with essential tremor.
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 888-632-3382 (US) or
785-424-1677 (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
800-839-2389 (US) or 402-220-7204 (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 INGREZZA, a vesicular monoamine
transporter 2 inhibitor for the treatment of movement
disorders. Neurocrine plans to commercialize INGREZZA in
the United States upon approval of
the NDA by the FDA..
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 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 reports on Form 10-Q for the quarters
ended March 31, 2016 and June 30, 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
September 30,
|
|
Nine Months
Ended
September 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
|
20,942
|
|
24,388
|
|
71,708
|
|
59,682
|
General and
administrative
|
17,494
|
|
11,456
|
|
44,413
|
|
23,541
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
38,436
|
|
35,844
|
|
116,121
|
|
83,223
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(38,436)
|
|
(35,844)
|
|
(101,121)
|
|
(63,454)
|
Other
income:
|
|
|
|
|
|
|
|
(Loss) gain on
sale/disposal of
assets
|
(9)
|
|
-
|
|
8
|
|
9
|
Deferred gain on real
estate
|
853
|
|
828
|
|
2,560
|
|
2,487
|
Investment income,
net
|
705
|
|
581
|
|
2,122
|
|
1,344
|
|
|
|
|
|
|
|
|
Total other
income
|
1,549
|
|
1,409
|
|
4,690
|
|
3,840
|
|
|
|
|
|
|
|
|
Net loss
|
$ (36,887)
|
|
$ (34,435)
|
|
$ (96,431)
|
|
$ (59,614)
|
|
|
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
(0.43)
|
|
$
(0.40)
|
|
$
(1.11)
|
|
$ (0.71)
|
|
|
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
86,784
|
|
85,856
|
|
86,659
|
|
83,927
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
|
|
|
|
|
|
September
30,
2016
|
|
December 31,
2015
|
Cash, cash equivalents
and short-term marketable securities
|
$
353,042
|
|
$
379,191
|
Other current
assets
|
4,849
|
|
4,883
|
|
|
|
|
Total current
assets
|
357,891
|
|
384,074
|
Property and
equipment, net
|
6,180
|
|
3,432
|
Long-term investments,
available for sale
|
30,207
|
|
82,488
|
Restricted
cash
|
4,883
|
|
4,791
|
|
|
|
|
Total
assets
|
$
399,161
|
|
$
474,785
|
|
|
|
|
Current
liabilities
|
$
26,666
|
|
$
25,715
|
Long-term
liabilities
|
20,844
|
|
24,616
|
Stockholders'
equity
|
351,651
|
|
424,454
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
399,161
|
|
$
474,785
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-third-quarter-2016-results-300356003.html
SOURCE Neurocrine Biosciences, Inc.