SAN DIEGO, April 30, 2015 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended March 31,
2015. For the first quarter of 2015, the Company reported a
net loss of $1.2 million, or
$0.01 loss per share, compared to a
net loss of $11.8 million, or
$0.17 loss per share, for the same
period in 2014.
The Company's balance sheet at March 31,
2015 reflected cash, cash equivalents, investments and
receivables of $517.9 million
compared to $232.6 million at
December 31, 2014. During the
quarter, the Company completed a public offering of eight million
shares of common stock that resulted in net proceeds of
approximately $270 million.
Additionally, the Company entered into a collaboration and license
agreement with Mitsubishi Tanabe Pharma Corporation for development
and commercialization of its VMAT2 inhibitor, NBI-98854, in
Japan and other select Asian
markets resulting in a $30 million
up-front payment.
"The first quarter of 2015 was very successful for Neurocrine;
starting with positive top-line elagolix Phase III data in
endometriosis, a successful capital raise and signing an Asian
partnership with Mitsubishi Tanabe for NBI-98854. This capital
raise provides the funding necessary to continue to advance our
pipeline, including moving NBI-98854 into commercialization upon
successful completion of the Phase III program and FDA approval,"
said Kevin Gorman, Ph.D., President
and Chief Executive Officer of Neurocrine Biosciences. "For the
balance of 2015, we turn our focus to executing across our pipeline
and advancing a novel compound from research into the clinic. Over
the coming eight months, we look forward to seven clinical trials
reading out across four distinct programs."
The $19.8 million of revenue for
the first quarter of 2015 represents recognized revenue in the form
of license fees from the NBI-98854 collaboration and license
agreement with Mitsubishi Tanabe that was executed on March 31, 2015. Research and development expenses
increased to $16.6 million during the
first quarter of 2015 from $8.6
million during the same period in 2014. This increase
was primarily due to higher external clinical development expenses
and associated internal costs related to the Company's VMAT2
inhibitor, NBI-98854, which initiated Phase III development in the
second half of 2014. Additionally, expenses related to the
Company's congenital adrenal hyperplasia program increased from the
first quarter of 2014. General and administrative expenses
increased from $4.2 million in the
first quarter of 2014 to $5.5 million
for the first quarter of 2015, primarily due to higher personnel
related costs, including a $0.5
million increase in share-based compensation expense.
Pipeline Highlights
VMAT2 Update
In 2014, the Company initiated a Phase III study of NBI-98854,
the Kinect 3 study. The Kinect 3 study, along with the previous
efficacy studies of NBI-98854, is designed to complete the
placebo-controlled clinical efficacy evaluation of NBI-98854 in
tardive dyskinesia. The primary endpoint in the Kinect 3 study is
the mean change from baseline in the Abnormal Involuntary Movement
Scale (AIMS) as assessed by blinded central raters. The Kinect 3
study includes approximately 240 subjects randomized to either
placebo, once daily 40mg of NBI-98854, or once daily 80mg of
NBI-98854 for six weeks of placebo-controlled dosing followed by an
extension of active dosing through Week 48. Top-line efficacy data
from the initial six weeks of placebo-controlled dosing is expected
in the second half of 2015.
A separate one-year open-label safety study of NBI-98854 has
also been initiated to support the anticipated 2016 filing of a New
Drug Application in tardive dyskinesia.
As announced previously, Neurocrine has also received
Breakthrough Therapy Designation from the FDA for NBI-98854 in the
treatment of tardive dyskinesia.
The Company is also exploring NBI-98854 in an initial Tourette
syndrome clinical trial, the T-Force study. This study is an
open-label, multi-dose, two-week evaluation of 36 subjects with
Tourette syndrome. Children and adolescents enrolled in the trial
are receiving a once-daily dose of NBI-98854 during a two-week
treatment period to assess both the safety and tolerability of
NBI-98854. Additionally, the Yale Global Tic Severity Scale and the
Premonitory Urge for Tics Scale are being utilized during the study
to assess the impact of NBI-98854 on the patients' Tourette
symptoms. Data read out from the T-Force study is expected in the
second half of 2015.
On March 31, 2015 the Company
entered into an exclusive collaboration and licensing agreement for
the development and commercialization of its VMAT2 inhibitor,
NBI-98854, in Japan and other
select Asian markets with Mitsubishi Tanabe Pharma Corporation.
Under the terms of the agreement, Neurocrine will receive an
initial payment of $30 million and is
eligible to receive up to $85 million
in additional milestone payments associated with the development
and commercialization of NBI-98854 in Asia. Upon commercialization, Neurocrine will
receive royalties on product sales from select territories in
Asia. Neurocrine will also support
Mitsubishi Tanabe's clinical efforts in developing NBI-98854 for
patients suffering from the chorea associated with Huntington's
disease and tardive dyskinesia.
Elagolix Update
During the first quarter of 2015, AbbVie announced positive
top-line results from the first of two ongoing Phase III clinical
trials, the Violet Petal Study, designed to evaluate the efficacy
and safety of elagolix in premenopausal women with endometriosis.
Results from the trial show 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 (p<0.001) of reducing
scores of non-menstrual pelvic pain (NMPP) 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 Violet
Petal Study was consistent with observations from prior studies.
Among the most common adverse events (AEs) were hot flush,
headache, nausea and fatigue. While most AEs were similar across
treatment groups some, such as hot flush and bone mineral density
(BMD) loss, were dose-dependent.
AbbVie is also conducting the second Phase III study of elagolix
for endometriosis, the Solstice Study. This study is similar in
design to the Violet Petal Study and will assess 788 women, age 18
to 49, with moderate to severe endometriosis-associated pain at
more than 200 sites globally. Top-line efficacy data from this
study is expected in late 2015.
Elagolix is also being evaluated in women with uterine fibroids.
AbbVie is conducting a Phase IIb clinical trial evaluating the
change in menstrual blood loss of 520 women, age 18-51, with heavy
menstrual bleeding associated with uterine fibroids. Patient
recruitment has recently been completed and top-line data from this
study is expected in 2015.
Corticotropin Releasing Factor (Congenital Adrenal
Hyperplasia) Update
The Company recently announced the completion of a pilot
clinical trial of NBI-77860 against placebo in adult females with
refractory classic congenital adrenal hyperplasia (CAH). This eight
person single dose exploratory study showed that NBI-77860 was
effective in reducing the key biomarkers of adrenocorticotropic
hormone (ACTH) and 17-hydroxyprogesterone androgen (17-OHP). A full
description of the study results and related data was presented at
the Endocrine Society's 97th Annual Meeting in
San Diego on March 5, 2015.
Neurocrine has initiated a second clinical trial assessing three
doses of NBI-77860 in an open-label, sequential cohort, single
ascending dose pharmacokinetic/pharmacodynamic study. Fifteen
adolescent females with classic CAH will be split into three
cohorts and each will receive one dose of NBI-77860 once a day.
Biomarker measurements include ACTH, 17-OHP, androgen and cortisol
levels collected the morning after dosing. Data from this study is
expected later in 2015.
Conference Call and Webcast Today at 8:00AM Eastern Time
Neurocrine will hold a live conference call and webcast today at
8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access
the live conference call by dialing 866-952-1906 (US) or
785-424-1825 (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 800-839-5127(US)
or 402-220-2692(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 NBI-98854, a vesicular
monoamine transporter 2 inhibitor for the treatment of movement
disorders. Neurocrine intends to maintain certain commercial rights
to its VMAT2 inhibitor for evolution into a fully-integrated
pharmaceutical company.
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 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 regulatory submissions may not occur or be submitted in
a timely manner; 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
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 and sales
activities; risks associated with the dependence on Mitsubishi
Tanabe for development and commercialization of NBI-98854 in
certain Asian countries; 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,
2014. 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)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
|
2015
|
|
2014
|
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
License
fees
|
$ 19,769
|
|
$
-
|
|
|
Total
revenues
|
19,769
|
|
-
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
16,575
|
|
8,572
|
|
General and
administrative
|
5,482
|
|
4,153
|
|
|
Total operating
expenses
|
22,057
|
|
12,725
|
|
|
|
|
|
|
Loss from
operations
|
(2,288)
|
|
(12,725)
|
|
|
|
|
|
|
Other
income:
|
|
|
|
|
Interest and other
income
|
257
|
|
89
|
|
Gain on sale of
assets, net
|
839
|
|
794
|
Total other
income
|
1,096
|
|
883
|
|
|
|
|
Net loss
|
$ (1,192)
|
|
$ (11,842)
|
Net loss per common
share:
|
|
|
|
|
Basic and
Diluted
|
$ (0.01)
|
|
$ (0.17)
|
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
Basic and
Diluted
|
80,349
|
|
70,260
|
NEUROCRINE
BIOSCIENCES, INC.
|
Condensed
Consolidated Balance Sheets
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
|
2015
|
|
2014
|
|
|
|
(unaudited)
|
Cash, cash
equivalents and short-term marketable securities
|
$370,007
|
|
$ 193,809
|
Other current
assets
|
34,946
|
|
4,394
|
|
Total current
assets
|
404,953
|
|
198,203
|
|
|
|
|
|
|
Property and
equipment, net
|
2,543
|
|
2,507
|
Long-term
investments
|
115,452
|
|
37,492
|
Restricted
cash
|
4,831
|
|
4,831
|
|
Total
assets
|
$527,779
|
|
$243,033
|
|
|
|
|
|
|
Current
liabilities
|
$15,187
|
|
$ 15,664
|
Long-term
liabilities
|
27,862
|
|
18,670
|
Stockholders'
equity
|
484,730
|
|
208,699
|
|
Total liabilities and
stockholders' equity
|
$527,779
|
|
$243,033
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-first-quarter-2015-results-300074799.html
SOURCE Neurocrine Biosciences, Inc.