SAN DIEGO, Feb. 13, 2018 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced its financial
results for the fourth quarter and year-end of 2017, and provided
an update on the launch of INGREZZA®
(valbenazine) and clinical development programs for
2018.
"This past year was a year of tremendous progress for Neurocrine
with the approval and successful launch of INGREZZA. I am proud of
our team's dedication and commitment to successfully launching
INGREZZA while also advancing key development programs in our
pipeline," said Kevin Gorman, Ph.D.,
Chief Executive Officer of Neurocrine Biosciences. "For 2018, we
remain focused on maximizing our opportunity with INGREZZA to aid
patients impacted by tardive dyskinesia through further disease
state awareness and positive patient outcomes. In addition, we
expect to make great strides in our many research and development
programs, including a potential FDA approval from our collaboration
with AbbVie for elagolix in endometriosis, results from a Phase IIb
study of INGREZZA for Tourette syndrome, and progressing opicapone
for the treatment of Parkinson's disease."
Fourth Quarter and Year-End 2017 Sales Results
Neurocrine reported net product sales for INGREZZA of
$64.5 million for the fourth quarter
ended December 31, 2017. Total
Company revenues for the fourth quarter were $94.5 million inclusive of a $30 million milestone payment received from
AbbVie for the U.S. Food and Drug Administration (FDA) acceptance
of the elagolix endometriosis NDA filing in the fourth quarter.
For the year ended December 31,
2017, net product sales of INGREZZA were $116.6 million and total Company revenues of
$161.6 million inclusive of
$45 million revenue recognized from
our collaboration agreements with AbbVie and Mitsubishi Tanabe
Pharma Corporation (Mitsubishi Tanabe).
No similar net product sales were reported for the comparable
periods of 2016. INGREZZA was made available for
commercial distribution on May 1,
2017, and the Company recognizes revenue using a sell-in
methodology when products are delivered to select pharmacies or
distributors.
For the fourth quarter of 2017, the Company reported net income
of $6.9 million, or $0.07 diluted earnings per share, compared to a
net loss of $44.7 million, or
$0.51 loss per share for the same
period in 2016. For the year ended December
31, 2017, the Company reported a net loss of $142.5 million, or $1.62 loss per share, as compared to a net loss
of $141.1 million, or $1.63 loss per share for 2016.
Research and development (R&D) expenses were $25.6 million during the fourth quarter of 2017
compared to $22.6 million for the
fourth quarter of 2016. The increase in R&D expense is
principally due to increased program activity in R&D. For the
year ended December 31, 2017, R&D
expenses were $121.8 million,
compared to $94.3 million for the
same period in 2016. This increase is primarily due to a
$30 million payment in the first
quarter of 2017 from the Company's entering 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, which was expensed as in-process
R&D.
Sales, general and administrative (SG&A) expenses increased
to $56.3 million for the fourth
quarter of 2017 from $23.7 million
for the fourth quarter of 2016. For the year ended
December 31, 2017, SG&A expenses
were $169.9 million, compared to
$68.1 million for the same period in
2016. The increase in SG&A expense, across both periods, is
primarily due to commercialization activities for INGREZZA.
The Company's balance sheet at December
31, 2017, reflected total assets of $817.6 million, including cash, investments and
receivables of $797.6 million,
compared with total asset balances at December 31, 2016 of $365.1 million.
2018 Financial Guidance
Revenue milestones under the AbbVie agreement for 2018 are
expected to be $40 million contingent
on an FDA approval of elagolix for endometriosis. Ongoing
operating expenses for 2018 should approximate $365 to $395
million. The 2018 anticipated expenses include an estimated
$50 million of share-based
compensation expense. The increase in operating expenses is
largely attributable to increased investment in INGREZZA sales and
marketing activities coupled with increased R&D efforts for
Tourette syndrome, opicapone, new early stage programs, and
post-marketing clinical activities.
Pipeline Highlights and Upcoming Events in
2018
INGREZZA Update
INGREZZA received FDA approval on April
11, 2017, becoming the first medicine approved in
the United States for the
treatment of adults with tardive dyskinesia. Full commercial
efforts for the 40 mg capsule of INGREZZA began on May 1, 2017. On October 4,
2017, the FDA approved the supplemental New Drug Application
(NDA) for the 80 mg capsule strength of INGREZZA.
In March 2015, the Company
announced that it had entered into an exclusive collaboration and
licensing agreement for the development and commercialization of
INGREZZA in Japan and other select
Asian markets with Mitsubishi Tanabe. In 2017, Mitsubishi Tanabe
initiated a pivotal trial of INGREZZA in Asia for the treatment of tardive dyskinesia
which generated a $15 million
milestone during the third quarter of 2017.
INGREZZA is being investigated in Tourette syndrome and has been
granted Orphan Drug Designation by the FDA for the treatment of
pediatric patients with Tourette syndrome. Orphan Drug Designation
is granted by the FDA to drugs that are intended to treat
rare diseases or conditions in the United
States.
In addition, the Company has advanced the valbenazine Tourette
syndrome program into Phase IIb by initiating the T-Force GOLD
study in pediatric patients with Tourette syndrome. This study is a
multicenter, randomized, double-blind, placebo-controlled, parallel
group, Phase IIb study to evaluate the safety, tolerability,
efficacy and optimal dose of once-daily valbenazine in up to 120
pediatric patients with moderate to severe Tourette syndrome over
12 weeks of treatment. 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 12 with
top-line data expected in late 2018.
Elagolix Update
On October 27, 2017, AbbVie, in
collaboration with Neurocrine, announced that the FDA had granted
Priority Review to elagolix for the management of endometriosis
with associated pain. The FDA grants Priority Review to medicines
that it determines have potential to provide significant
improvements in the safety and effectiveness of the treatment of a
serious disease. Priority Review shortens the FDA review timeframe
from ten months from acceptance of the NDA filing to six months.
The Prescription Drug User Fee Act (PDUFA) date for the FDA
to complete its review is in the second quarter of 2018.
AbbVie is currently completing 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 enrolled 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 dual-energy x-ray absorptiometry (DEXA) scan
at baseline, at the conclusion of dosing, and six months
post-dosing. AbbVie expects initial top-line efficacy data from the
uterine fibroid Phase III program during the first quarter of 2018.
These two studies will form the basis for an anticipated 2019
supplemental NDA submission to the FDA for the approval of elagolix
in the treatment of uterine fibroids.
Opicapone Update
In February 2017, the Company
entered into an exclusive licensing agreement with BIAL for the
development and commercialization of opicapone in the United States and Canada. Opicapone is a once-daily,
peripherally-acting, highly-selective catechol-o-methyltransferase
inhibitor being developed as an adjunct therapy to preparations of
levodopa/DOPA decarboxylase inhibitors for adult patients with
Parkinson's disease and motor fluctuations. The Company met with
the FDA in January to discuss the necessary activities to support
an NDA submission and will provide an update on the regulatory path
and program timing after official meeting minutes are received
later this month.
Congenital Adrenal Hyperplasia (CAH) Program (NBI-74788)
Update
In the second quarter of 2017, the Company successfully
completed the Phase I, IND-opening study of NBI-74788 in healthy
volunteer subjects. The study was a randomized, open-label,
two-period crossover study to evaluate the pharmacokinetics (PK),
the effect of food on PK, and the safety of NBI-74788 in a total of
16 healthy adults.
The Company began recruitment for a Phase II, proof-of-concept
study examining the PK, pharmacodynamics, and safety of NBI-74788
in adult males and females with classic, 21-hydroxylase deficiency
CAH in November of 2017. The study will evaluate the relationship
between NBI-74788 exposures and specific steroid hormone levels in
these subjects and expect data to be available during the first
half of 2018.
Conference Call and Webcast Today at 5:00 PM 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 888-632-3389 (US) or
785-424-1673 (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.
About INGREZZA® (valbenazine)
Capsules
INGREZZA, a selective VMAT2 inhibitor, is the first
FDA approved product indicated for the treatment of adults with
tardive dyskinesia, a condition associated with uncontrollable,
abnormal and repetitive movements of the trunk, extremities and/or
face.
INGREZZA is thought to work by reducing the amount of dopamine
released in a region of the brain that controls movement and motor
function, helping to regulate nerve signaling in adults with
tardive dyskinesia. VMAT2 is a protein in the brain that packages
neurotransmitters, such as dopamine, for transport and release in
presynaptic neurons. INGREZZA, developed in Neurocrine's
laboratories, is novel in that it selectively inhibits VMAT2 with
no appreciable binding affinity for VMAT1, dopaminergic (including
D2), serotonergic, adrenergic, histaminergic, or muscarinic
receptors. Additionally, INGREZZA can be taken for the treatment of
tardive dyskinesia as one capsule, once-daily, together with
psychiatric medications such as antipsychotics or
antidepressants.
Important Safety Information
Warnings &
Precautions
Somnolence
INGREZZA can cause
somnolence. Patients should not perform activities requiring mental
alertness such as operating a motor vehicle or operating hazardous
machinery until they know how they will be affected by
INGREZZA.
QT Prolongation
INGREZZA may prolong the QT interval,
although the degree of QT prolongation is not clinically
significant at concentrations expected with recommended dosing.
INGREZZA should be avoided in patients with congenital long QT
syndrome or with arrhythmias associated with a prolonged QT
interval. For patients at increased risk of a prolonged QT
interval, assess the QT interval before increasing the dosage.
Adverse Reactions
The most common adverse reaction
(≥5% and twice the rate of placebo) is somnolence. Other adverse
reactions (≥2% and >placebo) include: anticholinergic effects,
balance disorders/falls, headache, akathisia, vomiting, nausea, and
arthralgia.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit MedWatch at
www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see INGREZZA full Prescribing Information at
www.INGREZZA.com/HCP
About Neurocrine Biosciences, Inc.
Neurocrine
Biosciences is a San Diego based biotechnology
company focused on neurologic, psychiatric and endocrine related
disorders. The Company markets INGREZZA® (valbenazine)
capsules in the United States for the treatment of adults
with tardive dyskinesia. INGREZZA is a novel, selective
vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the
first FDA approved product indicated for the treatment of adults
with tardive dyskinesia. The Company's three late-stage
clinical programs are: elagolix, a gonadotropin-releasing hormone
antagonist for women's health that is partnered with AbbVie
Inc.; opicapone, a novel, once-daily, peripherally-acting,
highly-selective catechol-o-methyltransferase inhibitor under
investigation as adjunct therapy to levodopa in Parkinson's
patients; and INGREZZA, a novel, once-daily, selective VMAT2
inhibitor under investigation for the treatment of Tourette
syndrome.
Neurocrine Biosciences, Inc. news releases are available through
the Company's website via the internet at
http://www.neurocrine.com.
Forward-Looking Statements
In addition to
historical facts, this press release contains forward-looking
statements that involve a number of risks and uncertainties. These
statements include, but are not limited to, statements related to
the benefits to be derived from Neurocrine's products and product
candidates, including INGREZZA; the value INGREZZA and our product
candidates may bring to patients; the success of the continued
launch of INGREZZA; and the timing of completion of our clinical
and other development activities and those of our collaboration
partners. Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking
statements are: the Company's future financial and operating
performance; risks and uncertainties associated with the
commercialization of INGREZZA, including the likelihood of
continued revenue growth of INGREZZA; risks or uncertainties
related to the development of the Company's product candidates;
risks and uncertainties relating to competitive products and
technological changes that may limit demand for INGREZZA or a
product candidate; risks associated with the Company's dependence
on third parties for development and manufacturing activities
related to INGREZZA and the Company's product candidates, and the
ability of the Company to manage these third parties; risks that
the FDA or other regulatory authorities may make adverse decisions
regarding INGREZZA or 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 agreements with BIAL and Mitsubishi
Tanabe may never be realized; 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 Mitsubishi Tanabe for the development and
commercialization of valbenazine in Japan and other Asian countries; risks that
INGREZZA and/or our product candidates may be precluded from
commercialization by the proprietary or regulatory rights of third
parties, or have unintended side effects, adverse reactions or
incidents of misuse; and other risks described in the Company's
periodic reports filed with the Securities and Exchange Commission,
including without limitation the Company's quarterly report on Form
10-Q for the quarter ended September 30,
2017. 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,
|
Twelve Months
Ended
December 31,
|
|
2017
|
2016
|
2017
|
2016
|
Revenues:
|
|
|
|
|
Product sales,
net
|
$
64,517
|
$
-
|
$ 116,626
|
$
-
|
Milestones
|
30,000
|
-
|
45,000
|
15,000
|
|
|
|
|
|
Total
revenues
|
94,517
|
-
|
161,626
|
15,000
|
Operating
expenses:
|
|
|
|
|
Cost of product
sales
|
760
|
-
|
1,254
|
-
|
Research and
development
|
25,614
|
22,583
|
121,827
|
94,291
|
Sales, general and
administrative
|
56,309
|
23,668
|
169,906
|
68,081
|
|
|
|
|
|
Total operating
expenses
|
82,683
|
46,251
|
292,987
|
162,372
|
|
|
|
|
|
Income (loss) from
operations
|
11,834
|
(46,251)
|
(131,361)
|
(147,372)
|
Other (expense)
income:
|
|
|
|
|
Deferred gain on real
estate
|
183
|
863
|
2,124
|
3,423
|
Interest
expense
|
(7,419)
|
-
|
(19,523)
|
-
|
Investment income,
net
|
2,323
|
716
|
6,238
|
2,838
|
Other (loss) income,
net
|
(27)
|
13
|
(20)
|
21
|
|
|
|
|
|
Total other (expense)
income
|
(4,940)
|
1,592
|
(11,181)
|
6,282
|
|
|
|
|
|
Net Income
(Loss)
|
$
6,894
|
$ (44,659)
|
$(142,542)
|
$(141,090)
|
|
|
|
|
|
Net income (loss) per
common share:
|
|
|
|
|
Basic
|
$
0.08
|
$
(0.51)
|
$
(1.62)
|
$
(1.63)
|
Diluted
|
$
0.07
|
$
(0.51)
|
$
(1.62)
|
$
(1.63)
|
|
|
|
|
|
Shares used in the
calculation of net income (loss) per common share:
|
|
|
|
|
Basic
|
88,665
|
86,874
|
88,089
|
86,713
|
Diluted
|
92,659
|
86,874
|
88,089
|
86,713
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
2017
|
|
2016
|
|
|
|
(unaudited)
|
Cash, cash
equivalents and short-term investments
|
$ 515,929
|
|
$ 307,350
|
Other current
assets
|
38,990
|
|
3,092
|
|
Total current
assets
|
554,919
|
|
310,442
|
|
|
|
|
|
|
Property and
equipment, net
|
10,811
|
|
6,271
|
Long-term
investments
|
247,361
|
|
43,490
|
Restricted
cash
|
4,500
|
|
4,883
|
|
Total
assets
|
$ 817,591
|
|
$365,086
|
|
|
|
|
|
|
Current
liabilities
|
$
54,426
|
|
$ 30,414
|
Convertible senior
notes
|
369,618
|
|
-
|
Other long-term
liabilities
|
21,409
|
|
19,795
|
Stockholders'
equity
|
372,138
|
|
314,877
|
|
Total liabilities and
stockholders' equity
|
$ 817,591
|
|
$365,086
|
|
|
|
|
|
|
|
|
|
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SOURCE Neurocrine Biosciences, Inc.