SAN DIEGO, Aug. 3, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended June 30,
2017, highlighted by the successful regulatory approval and
commercial launch of INGREZZA® (valbenazine) capsules in
tardive dyskinesia, as well as other recent progress on its
pipeline.
"We are very pleased with the initial months of INGREZZA's
launch and are encouraged by the positive feedback we are receiving
from patients, physicians, and caregivers," said Kevin Gorman, Ph.D., Chief Executive Officer of
Neurocrine Biosciences. "We successfully deployed our sales force
on May 1st and activated our
patient and prescriber support system, INBRACE; we are continuing
to expand awareness of INGREZZA among healthcare professionals
through multiple initiatives ranging from symposia at major medical
meetings to local speaker programs; we are working with payors to
make INGREZZA available to eligible patients; and we continue to
see strong growth in prescription volume. Finally, we remain as
committed as ever to our science and to advancing our robust
pipeline."
Financial Results
Neurocrine reported net product sales of $6.3 million for the three months ended
June 30, 2017. No similar net product
sales were reported for the comparable period 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 second quarter of 2017, the Company reported a net loss
of $60.0 million, or $0.68 loss per share, compared to a net loss of
$40.3 million, or $0.46 loss per share, for the same period in
2016. For the six months ended June 30,
2017, the Company reported a net loss of $138.3 million, or $1.58 loss per share, as compared to a net loss
of $59.5 million, or $0.69 loss per share, for the first half of last
year.
Research and development (R&D) expenses were $21.9 million during the second quarter of 2017
compared to $26.9 million for the
same period in 2016. The decrease in R&D expense is
principally due to the completion of pivotal studies for INGREZZA.
For the six months ended June 30,
2017, R&D expenses were $73.8
million, compared to $50.8
million for the same period last year. This increase is
primarily due 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.
Selling, general and administrative (SG&A) expenses
increased to $41.7 million for the
second quarter of 2017 from $15.0
million for the second quarter of 2016. For the six
months ended June 30, 2017, SG&A
expenses were $69.7 million, compared
to $26.9 million for the first half
of 2016. The increase in SG&A expense is primarily due to
commercialization activities for INGREZZA and, in particular, the
on-boarding of our full sales organization.
The Company's balance sheet at June 30,
2017, reflected total assets of $754.1 million, including cash, investments and
receivables of $739.6 million,
compared with total asset balances at March
31, 2017 and December 31, 2016
of $289.4 million and $365.1 million, respectively. These assets
include the $502.8 million raised,
net of expenses, via the Company's convertible notes offering which
closed on May 2, 2017.
Pipeline Highlights
INGREZZA (valbenazine) Update
INGREZZA received U.S. Food and Drug Administration (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 on May 1, 2017. On June 14,
2017, the Company submitted a supplemental New Drug
Application (NDA) with the FDA for the approval of 80 mg capsules
of INGREZZA for the treatment of tardive dyskinesia. Pending
notification of the acceptance by the FDA of the supplemental NDA,
the Company has been advised that the Prescription Drug User Fee
Act (PDUFA) goal date is October 14,
2017. In July 2017, Neurocrine
completed the INGREZZA roll-over study for those patients who had
previously completed one year of dosing in either the Kinect 3 or
Kinect 4 study.
In March 2015, the Company
announced that it has 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 Pharma Corporation (Mitsubishi
Tanabe). Mitsubishi Tanabe expects to initiate a pivotal trial of
INGREZZA in Asia for the treatment
of tardive dyskinesia and pay $15
million in related milestones in the third quarter of
2017.
INGREZZA is also being investigated in Tourette syndrome for
both adult and pediatric patients.
The T-Force GREEN study was a randomized, double-blind,
placebo-controlled, multi-dose, parallel-group Phase II study that
enrolled 94 children and adolescents. Pediatric subjects with
Tourette syndrome 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 was the change from baseline of the Yale Global Tic Severity
Scale (YGTSS) at the end of Week 6 in the intent-to-treat (ITT)
population between placebo and active treatment groups. On
May 23, 2017, the Company reported
that the T-Force GREEN study did not meet its primary endpoint.
Exposure-response analysis showed that the selected doses for this
placebo-controlled Phase II study were below the therapeutic range
for adequate tic reduction in the majority of pediatric subjects
and provided insight into the level of dosing required for future
studies.
Additionally, the Company is also conducting an open-label,
fixed-dose study of INGREZZA in up to 180 subjects with Tourette
syndrome 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 syndrome.
Data from the Tourette studies has been utilized to design a
Phase IIB trial for INGREZZA in treating Tourette syndrome with
study initiation planned for late 2017.
Elagolix Update
AbbVie is on track to submit the NDA to the FDA for elagolix in
endometriosis during the third quarter of 2017.
In May 2017, AbbVie presented
seven scientific abstracts at the 13th World Congress on
Endometriosis (WCE) in Vancouver,
Canada. The presentations and posters highlighted the
positive efficacy and safety data from the Phase III studies of
elagolix in premenopausal women who suffer from
endometriosis. Following the presentations at the WCE, AbbVie
published a comprehensive disclosure of the elagolix Phase III
program in the New England Journal of Medicine (Treatment of
Endometriosis-Associated Pain with Elagolix, an Oral GnRH
Antagonist; Taylor, 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, at the conclusion of dosing, and six
months post-dosing. AbbVie expects 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 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 COMT inhibitor being
developed 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 and BIAL have completed the
transfer of materials needed to update the Investigational New Drug
(IND) application and prepare a briefing package to support a
discussion with the FDA later this year. The outcome of this
meeting will inform the activities needed to support regulatory
submission to the FDA.
Congenital Adrenal Hyperplasia 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 exposure data from this study support
the doses and formulation of NBI-74788 that will be investigated in
a follow-up clinical trial in classic congenital adrenal
hyperplasia (CAH) patients.
The Company will initiate 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 the third quarter of 2017. The study will evaluate the
relationship between NBI-74788 exposures and specific steroid
hormone levels in these subjects.
Essential Tremor Program (NBI-640756) Update
The Company is conducting a 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 in the third quarter of 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.
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 888-632-3381 (US) or
785-424-1678 (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. 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 tardive dyskinesia. 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
approved 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 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 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 and our product candidates may bring 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 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; 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 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 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, and Quarterly Report on Form
10-Q for the quarter ended March 31,
2017. 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)
(unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
6,335
|
|
$
-
|
|
$
6,335
|
|
$
-
|
License fees and
milestones
|
-
|
|
-
|
|
-
|
|
15,000
|
|
|
|
|
|
|
|
|
Total
revenues
|
6,335
|
|
-
|
|
6,335
|
|
15,000
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product
sales
|
61
|
|
-
|
|
61
|
|
-
|
Research and
development
|
21,868
|
|
26,863
|
|
73,750
|
|
50,766
|
General and
administrative
|
41,674
|
|
14,965
|
|
69,724
|
|
26,919
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
63,603
|
|
41,828
|
|
143,535
|
|
77,685
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(57,268)
|
|
(41,828)
|
|
(137,200)
|
|
(62,685)
|
Other (expense)
income:
|
|
|
|
|
|
|
|
Gain on sale/disposal
of
assets
|
2
|
|
14
|
|
2
|
|
17
|
Deferred gain on real
estate
|
879
|
|
854
|
|
1,758
|
|
1,707
|
Interest
expense
|
(4,767)
|
|
-
|
|
(4,767)
|
|
-
|
Investment income,
net
|
1,169
|
|
680
|
|
1,896
|
|
1,417
|
|
|
|
|
|
|
|
|
Total other (expense)
income
|
(2,717)
|
|
1,548
|
|
(1,111)
|
|
3,141
|
|
|
|
|
|
|
|
|
Net Loss
|
$ (59,985)
|
|
$ (40,280)
|
|
$(138,311)
|
|
$(59,544)
|
|
|
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
(0.68)
|
|
$
(0.46)
|
|
$
(1.58)
|
|
$
(0.69)
|
|
|
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
|
|
|
Basic and
diluted
|
88,063
|
|
86,694
|
|
87,675
|
|
86,595
|
|
|
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
2017
|
|
2016
|
|
|
|
(unaudited)
|
Cash, cash
equivalents and short-term investments
|
$ 525,020
|
|
$ 307,350
|
Other current
assets
|
11,731
|
|
3,092
|
|
Total current
assets
|
536,751
|
|
310,442
|
|
|
|
|
|
|
Property and
equipment, net
|
6,954
|
|
6,271
|
Long-term
investments
|
205,768
|
|
43,490
|
Restricted
cash
|
4,613
|
|
4,883
|
|
Total
assets
|
$ 754,086
|
|
$365,086
|
|
|
|
|
|
|
Current
liabilities
|
$
27,721
|
|
$ 30,414
|
Convertible senior
notes
|
360,681
|
|
-
|
Other long-term
liabilities
|
20,446
|
|
19,795
|
Stockholders'
equity
|
345,238
|
|
314,877
|
|
Total liabilities and
stockholders' equity
|
$ 754,086
|
|
$365,086
|
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SOURCE Neurocrine Biosciences, Inc.