SAN DIEGO, May 9, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended March 31,
2017, highlighted by the launch of
INGREZZA® (valbenazine) capsules in tardive
dyskinesia as well as other recent progress on its pipeline.
"2016 was a very successful year for Neurocrine and we have
carried this momentum fully into 2017 with the approval and launch
of INGREZZA in tardive dyskinesia," said Kevin Gorman, Ph.D., Chief Executive Officer of
Neurocrine Biosciences. "On the commercial front, we accelerated
the on-boarding of our sales force and we began calling on
prescribers on May 1st. While we are
focused on the launch of INGREZZA, we also continue to advance our
pipeline. We will have data with INGREZZA in pediatric patients
with Tourette syndrome later this month. Our partner, AbbVie,
remains on track to submit the NDA for elagolix in endometriosis
during the third quarter of this year. Together with our partner
BIAL, we are progressing with our technology transfer activities in
order to initiate discussions with the FDA on opicapone in
Parkinson's disease in the second half of the year. Our second
Phase I study in essential tremor with NBI-640756 in healthy
volunteers continues, and we initiated a Phase I, healthy
volunteer, study of our candidate NBI-74788 for congenital adrenal
hyperplasia in March."
For the first quarter of 2017, the Company reported a net loss
of $78.3 million, or $0.90 loss per share, compared to a net loss of
$19.3 million, or $0.22 loss per share, for the same period in
2016.
The Company's balance sheet at March 31,
2017 reflected total assets of $289.4
million, including cash, investments and receivables of
$274.4 million compared with balances
at December 31, 2016 of $365.1 million and $352.1
million, respectively. These assets do not include the
approximately $502.2 million raised,
after expenses, via the Company's convertible notes offering which
closed on May 2, 2017.
The Company did not report any revenue for the first quarter of
2017 compared to $15.0 million of
revenue for the first quarter of 2016, which represented a
milestone payment from AbbVie related to the commencement of Phase
III studies of elagolix in uterine fibroids.
Research and development expenses increased to $51.9 million during the first quarter of 2017
from $23.9 million during the same
period in 2016. This increase was primarily due to the
$30.0 million up-front payment for
in-licensing opicapone from BIAL – Portela & CA, S.A. (BIAL)
during the first quarter of 2017.
General and administrative expenses increased from $12.0 million in the first quarter of 2016 to
$28.1 million for the first quarter
of 2017, primarily due to increased pre-commercialization
activities for INGREZZA. Personnel-related costs increased by
$6.9 million quarter over quarter
primarily due to the expansion of sales, marketing, and medical
affairs personnel. This increase in personnel-related costs
includes a $1.4 million increase in
non-cash, share-based compensation expense. Additionally, external
costs related to market research, commercial launch preparation and
other professional services were $7.2 million higher for the first quarter of
2017 when compared to the same period in 2016.
Pipeline Highlights
INGREZZA (valbenazine) Capsules Update
INGREZZA received FDA approval on April
11, 2017, becoming the first and only medicine approved in
the United States for adults with
tardive dyskinesia. Full commercial efforts began for
INGREZZA on May 1, 2017.
During March of 2017, the Company published 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, and for a subset, an additional 42 weeks of safety
assessment.
In addition to the long-term safety assessment of Kinect 3, the
Company announced that it completed in March
2017 its separate one-year open-label safety study of
INGREZZA, Kinect 4. Data publication is anticipated later this
year. The Company also announced that in July 2017 it plans to complete the INGREZZA
roll-over study for those patients who had previously completed one
year of dosing in either the Kinect 3 or Kinect 4 studies.
INGREZZA is also being investigated in Tourette syndrome for
both adult and pediatric patients.
The T-Forward study of adult Tourette syndrome patients reported
top-line data in January 2017. This
randomized, double-blind, placebo-controlled, multi-dose, parallel
group Phase II study enrolled 124 adults with moderate to severe
Tourette syndrome. 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 those
observed in previous clinical studies of INGREZZA.
The T-Force GREEN study is a randomized, double-blind,
placebo-controlled, multi-dose, parallel group Phase II 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 late May
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 April 2017, AbbVie presented
multiple scientific abstracts at the Congress of the Society of
Endometriosis and Uterine Disorders (SEUD) in Singapore. The posters 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 positive efficacy and safety data from the
Phase IIb study of elagolix with and without add-back therapy in
the management of heavy menstrual bleeding associated with uterine
fibroids:
- Rapid and Sustained Improvement in Dysmenorrhea and
Non-Menstrual Pelvic Pain with Elagolix Treatment in Women with
Endometriosis-associated pain; Taylor, et
al.
- Effective and Rapid Control of Bleeding with Elagolix with
or without Add-Back Therapy in Women with Heavy Menstrual Bleeding
Associated with Uterine
Fibroids; Gordon, et al.
AbbVie is 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 dual-energy x-ray absorptiometry
(DEXA) 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, 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 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. The Company intends to meet with
the FDA in late 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
In the fourth quarter of 2016, the Company 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 has enrolled
subjects in a Phase I safety and pharmacokinetics study exploring
NBI-74788 in healthy volunteers that is nearing completion.
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 877-876-9177 (US) or
785-424-1666 (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 Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a San
Diego based biotechnology company focused on neurologic,
psychiatric and endocrine related disorders. In April of 2017, the
FDA approved INGREZZA® (valbenazine)
capsules for the treatment of adults with Tardive Dyskinesia
(TD). INGREZZA is a novel, selective vesicular monoamine
transporter 2 (VMAT2) inhibitor, and is the first and only
FDA-approved product indicated for the treatment of adults with
TD. The Company markets INGREZZA in the United States. 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 (valbenazine), 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.
About INGREZZA
INGREZZA, a selective VMAT2 inhibitor, is the first and only
product indicated for the treatment of adults with tardive
dyskinesia. INGREZZA inhibits VMAT2 and 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 TD. 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
once-daily, and together with psychiatric medications such as
antipsychotics or antidepressants.
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 brings to patients; and whether results from
INGREZZA's clinical trials are indicative of real-world
results. 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 commercialization of INGREZZA or
the development of the Company's product candidates; risks and
uncertainties relating to competitive products and technological
changes that may limit demand for INGREZZA; risks associated with
the Company's dependence on third parties for development and
manufacturing activities related to INGREZZA 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; 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 associated with the Company's dependence on BIAL
for tech transfer, development and manufacturing activities related
to opicapone; risks that INGREZZA and/or our 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; and other risks described in the Company's
periodic reports filed with the Securities and Exchange Commission,
including without limitation the Company's Annual Report on Form
10-K for the year ended December 31, 2016.
Neurocrine disclaims 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,
|
|
|
|
2017
|
|
2016
|
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
License fees and
milestones
|
$
-
|
|
$
15,000
|
|
|
Total
revenues
|
-
|
|
15,000
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
51,882
|
|
23,903
|
|
General and
administrative
|
28,050
|
|
11,954
|
|
|
Total operating
expenses
|
79,932
|
|
35,857
|
|
|
|
|
|
|
Loss from
operations
|
(79,932)
|
|
(20,857)
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
Interest and other
income
|
727
|
|
737
|
|
Gain on sale of
assets
|
879
|
|
856
|
Total other
income
|
1,606
|
|
1,593
|
|
|
|
|
Net loss
|
$
(78,326)
|
|
$
(19,264)
|
Net loss per common
share:
|
|
|
|
|
Basic and
Diluted
|
$
(0.90)
|
|
$
(0.22)
|
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
Basic and
Diluted
|
87,283
|
|
86,497
|
|
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
|
2017
|
|
2016
|
|
|
|
(unaudited)
|
Cash, cash
equivalents and short-term marketable securities
|
$235,580
|
|
$ 307,350
|
Other current
assets
|
3,871
|
|
3,092
|
|
Total current
assets
|
239,451
|
|
310,442
|
|
|
|
|
|
|
Property and
equipment, net
|
7,144
|
|
6,271
|
Long-term
investments
|
37,686
|
|
43,490
|
Restricted
cash
|
5,083
|
|
4,883
|
|
Total
assets
|
$289,364
|
|
$365,086
|
|
|
|
|
|
|
Current
liabilities
|
$23,563
|
|
$ 30,414
|
Long-term
liabilities
|
18,660
|
|
19,795
|
Stockholders'
equity
|
247,141
|
|
314,877
|
|
Total liabilities and
stockholders' equity
|
$289,364
|
|
$365,086
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-first-quarter-2017-results-300454615.html
SOURCE Neurocrine Biosciences, Inc.