SAN DIEGO, Feb. 14, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter and full year 2016, and highlighted recent
progress on its pipeline.
"2016 was a very successful year for Neurocrine highlighted by
the filing of our INGREZZA New Drug Application for tardive
dyskinesia which was granted Priority Review by the FDA with a
PDUFA date of April 11, 2017," said
Kevin Gorman, Ph.D., Chief Executive
Officer of Neurocrine Biosciences. "2017 will truly be a pivotal
year for Neurocrine; we have been preparing all aspects of the
company for the anticipated commercial launch of INGREZZA in
the United States. We also
in-licensed the U.S. commercial rights to opicapone for Parkinson's
disease, a novel COMT inhibitor recently approved in Europe. In addition, our partner AbbVie is
planning to submit the NDA for elagolix in endometriosis
during the third quarter of this year and is also anticipating
top-line data from the pivotal studies of elagolix in uterine
fibroids at year end. Our 2017 plans put us firmly on track to
achieve our goal of building a multi-product, commercial-stage
company with a robust and sustainable pipeline."
For the fourth quarter of 2016, the Company reported a net loss
of $44.7 million, or $0.51 loss per share, compared to a net loss of
$29.3 million, or $0.34 loss per share for the same period in 2015.
For the year ended December 31, 2016,
the Company reported a net loss of $141.1
million, or $1.63 loss per
share, as compared to a net loss of $88.9
million, or $1.05 loss per
share for 2015. 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, INGREZZATM (valbenazine) pre-commercialization
activities for tardive dyskinesia and higher share-based
compensation expense as detailed below.
The Company's balance sheet at December
31, 2016 reflected total assets of $365.1 million, including cash, investments and
receivables of $352.1 million
compared with balances at December 31,
2015 of $474.8 million and
$464.3 million, respectively.
Research and development expenses were $22.6 million during the fourth quarter of 2016,
compared to $21.8 million for the
same period in 2015. For the year ended December 31, 2016, research and development
expenses were $94.3 million, compared
to $81.5 million for all of 2015.
Quarterly research and development expense increased by
approximately $0.8 million from 2015
to 2016 primarily due to expenses related to the Company's New Drug
Application (NDA) for INGREZZA in tardive dyskinesia. The
$12.8 million increase in research
and development expenses from 2015 to 2016 was primarily due to
expenses related to the Company's compilation and filing of its NDA
for INGREZZA in tardive dyskinesia as well as higher external
clinical development expenses related to INGREZZA, which is being
evaluated in both tardive dyskinesia and Tourette syndrome.
General and administrative expenses increased from $8.9 million for the fourth quarter of 2015 to
$23.7 million for the fourth quarter
of 2016. For the year ended December 31,
2016 general and administrative expenses were $68.1 million, compared to $32.5 million for the prior year. The overall
increase in general and administrative expense is primarily due to
pre-commercialization activities for INGREZZA. Personnel related
costs increased by $5.7 million
quarter over quarter, and by $13.5
million from 2015 to 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 $6.7 million quarter over quarter and by
$15.1 million for 2016 compared to
2015.
2017 Financial Guidance
Revenues from milestones under the AbbVie agreement for 2017 are
expected to be $30 million. Ongoing
operating expenses for 2017 should approximate $230 million to $240 million, exclusive of the
$30 million up-front fee for
in-licensing opicapone. The 2017 anticipated expenses include an
estimated $40 million of share-based
compensation expense. The increase in expected expenses is
primarily related to anticipated commercialization activities for
INGREZZA in tardive dyskinesia.
Pipeline Highlights and Upcoming Events in
2017
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 for tardive dyskinesia 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 as well as long-term safety and efficacy
results in the fourth quarter of 2016.
The Company is currently conducting a separate one-year
open-label safety study of INGREZZA, the Kinect 4 study. 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 for
both adult and pediatric patients.
The T-Forward study of adult Tourette syndrome patients recently
reported top-line data. This randomized, double-blind,
placebo-controlled, multi-dose, parallel group study enrolled 124
adults with moderate to severe Tourette's. The subjects received
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 T-Forward was a change from
baseline of placebo vs. active scores utilizing the Yale Global Tic
Severity Scale (YGTSS) at the end of Week 8. The primary endpoint
of YGTSS was not met at Week 8 (p=0.18), however the study showed a
significant improvement in overall symptoms of Tourette as
evidenced by the Clinical Global Impression of Change (p=0.015).
Adverse events (AEs) in this trial were dose dependent and
consistent with earlier clinical studies of INGREZZA.
The T-Force GREEN study is a randomized, double-blind,
placebo-controlled, multi-dose, parallel group study that has
enrolled approximately 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 YGTSS between placebo and
active treatment groups at the end of Week 6. Top-line data from
this study is expected in the second quarter of 2017.
Additionally, the Company is also conducting 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.
Data from the Tourette studies is planned to be utilized to
design a Phase III pivotal program for INGREZZA in treating
Tourette syndrome.
Elagolix Update
AbbVie has completed the treatment portion of both Phase III
studies of elagolix in endometriosis. The first study (Violet
PETAL) has completed its off-drug follow-up period. The second
study (Solstice) will complete the off-drug follow-up period during
the second quarter of 2017. The top-line results from both trials
were consistent showing 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 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.
Among the most common AEs in both studies 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 an NDA submission with the FDA for
elagolix in endometriosis during the third quarter of 2017.
In October 2016, 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.
AbbVie is also currently conducting two replicate Phase III
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 late 2017. These two studies will form the basis for an
anticipated 2019 submission with the FDA for the approval of
elagolix in the treatment of uterine fibroids.
Opicapone Update
On February 9, 2017, we entered
into an exclusive licensing agreement with BIAL – Portela & CA,
S.A. (BIAL) for the development and commercialization of opicapone
in the United States and
Canada. Opicapone is a once-daily,
peripherally-acting, highly-selective COMT inhibitor that was
approved in June 2016 by the European
Commission as an adjunct therapy to preparations of levodopa/DOPA
decarboxylase inhibitors for adult patients with Parkinson's
disease and end-of-dose motor fluctuations who cannot be stabilized
on those combinations. We intend to meet with the FDA in 2017 to
discuss a potential New Drug Application submission.
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 2017. 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.
Congenital Adrenal Hyperplasia Program (NBI-74788)
Update
The Company has submitted an Investigational New Drug
application with the FDA for its CRF receptor antagonist NBI-74788
to treat patients with classic congenital adrenal hyperplasia
(CAH). The Company intends to initiate a Phase I safety and
pharmacokinetics study exploring NBI-74788 in healthy volunteers during 2017.
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
800-839-6136 (US) or 402-220-2572 (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. Specifically,
the risks and uncertainties the Company faces include risks that
INGREZZA or the Company's other 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 benefits of the
agreement with BIAL may never be realized; 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 BIAL for tech transfer,
development and manufacturing activities related to opicapone;
risks associated with the Company's dependence on other third
parties for development, manufacturing and marketing activities;
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, June 30, 2016 and September 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
December 31,
|
Year Ended
December 31,
|
|
2016
|
2015
|
2016
|
2015
|
Revenues:
|
|
|
|
|
Milestones and license fees
|
$
-
|
$
-
|
$
15,000
|
$
19,769
|
|
|
|
|
|
Total
revenues
|
-
|
-
|
15,000
|
19,769
|
Operating
expenses:
|
|
|
|
|
Research and development
|
22,583
|
21,809
|
94,291
|
81,491
|
General and administrative
|
23,668
|
8,939
|
68,081
|
32,480
|
|
|
|
|
|
Total operating expenses
|
46,251
|
30,748
|
162,372
|
113,971
|
|
|
|
|
|
Loss from
operations
|
(46,251)
|
(30,748)
|
(147,372)
|
(94,202)
|
Other
income:
|
|
|
|
|
Gain on sale/disposal of assets
|
-
|
-
|
8
|
9
|
Deferred gain on real estate
|
863
|
838
|
3,423
|
3,325
|
Investment income, net
|
716
|
584
|
2,838
|
1,928
|
Other income, net
|
13
|
11
|
13
|
11
|
|
|
|
|
|
Total other income
|
1,592
|
1,433
|
6,282
|
5,273
|
|
|
|
|
|
Net loss
|
$ (44,659)
|
$ (29,315)
|
$
(141,090)
|
$
(88,929)
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
Basic and Diluted
|
$
(0.51)
|
$
(0.34)
|
$
(1.63)
|
$
(1.05)
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
Basic and Diluted
|
86,874
|
86,184
|
86,713
|
84,496
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
|
|
December 31,
2016
|
December 31,
2015
|
Cash, cash
equivalents and short-term investments
|
$
307,350
|
$
379,191
|
Other current
assets
|
3,092
|
4,883
|
|
|
|
Total current assets
|
310,442
|
384,074
|
Property and
equipment, net
|
6,271
|
3,432
|
Long-term
investments
|
43,490
|
82,488
|
Restricted
cash
|
4,883
|
4,791
|
|
|
|
Total assets
|
$
365,086
|
$
474,785
|
|
|
|
Current
liabilities
|
$
30,414
|
$
25,715
|
Long-term
liabilities
|
19,795
|
24,616
|
Stockholders'
equity
|
314,877
|
424,454
|
|
|
|
Total liabilities and stockholders' equity
|
$
365,086
|
$
474,785
|
|
|
|
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SOURCE Neurocrine Biosciences, Inc.