SAN DIEGO, Feb. 9, 2015 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter and year ended December 31, 2014.
For the fourth quarter of 2014, the Company reported a net loss
of $19.4 million, or $0.26 loss per share, compared to a net loss of
$10.6 million, or $0.16 loss per share for the same period in 2013.
For the year ended December 31, 2014,
the Company reported a net loss of $60.5
million, or $0.81 loss per
share, as compared to a net loss of $46.1 million, or $0.69 loss per share for 2013. The increase in
net loss for the fourth quarter and full year result primarily from
increased research and development expenses in connection with the
Company's expanding clinical stage pipeline and higher share-based
compensation expense as detailed below.
The Company's balance sheet at December
31, 2014 reflected total assets of $243.0 million, including cash, investments and
receivables of $232.6 million
compared with balances at December 31,
2013 of $154.7 million and
$146.8 million, respectively.
"We began 2015 with positive data from our partner AbbVie in the
initial Phase III study of elagolix in endometriosis and now look
forward to seven additional clinical trial readouts for the balance
of this year; 2015 will be the most data rich year in our history,"
said Kevin Gorman, Ph.D., President
and Chief Executive Officer of Neurocrine Biosciences.
"Additionally, our investment in basic research has yielded a new
compound for our clinical pipeline and we expect to file an
Investigational New Drug application during the second quarter with
Phase I clinical results later in the year."
Research and development expenses were $15.5 million during the fourth quarter of 2014,
compared to $8.9 million for the same
period in 2013. General and administrative expenses increased
from $3.3 million for the fourth
quarter of 2013 to $5.0 million for
the fourth quarter of 2014. For the year ended December 31, 2014, research and development
expenses were $46.4 million, compared
to $39.2 million for all of 2013,
while general and administrative expenses were $18.0 million during 2014, compared to
$13.3 million for the prior year. The
increase in year-to-date expenses is primarily due to an increase
in personnel costs of $8.3 million,
with share-based compensation expense representing $3.6 million of this increase. The Company
increased its research and development headcount during 2014 in
response to its clinical pipeline expansion. Additionally, higher
external clinical development costs and early research costs
resulted in a net increase of approximately $1.7 million from 2013 levels.
2015 Financial Guidance
The Company expects to have a gross cash burn, prior to any
revenue, of approximately $80 million to $85
million in 2015. The increase in cash burn from 2014 is
primarily due to the expansion and progression of the clinical
pipeline. Expenses for 2015 should approximate $106 million to $111 million. The anticipated
increase in expenses over 2014 levels also includes an estimated
$15 million increase in share-based
compensation expense, partially due to anticipated partial vesting
of certain performance-based restricted stock units.
Pipeline Highlights
VMAT2 Update
The Company recently 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 is also
being initiated to support the anticipated 2016 filing of a New
Drug Application in tardive dyskinesia.
Neurocrine recently 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 once-daily dosing of NBI-98854 during a two-week
treatment period to assess both the safety and tolerability of
NBI-98854 in Tourette patients. 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 readout from the T-Force study is
expected in the second half of 2015.
Elagolix Update
AbbVie recently 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. 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 will be presented
at the Endocrine Society's 97th Annual Meeting on
March 5, 2015 in San Diego.
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 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 877-888-4314 (US) or
785-424-1875 (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 800-839-2385 (US)
or 402-220-7203 (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 a wholly owned 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 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, 2013 and quarterly reports on Form
10-Q for the quarters ended March 31,
2014, June 30, 2014 and
September 30, 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)
(unaudited)
|
|
|
|
|
Three Months
Ended
December 31,
|
Year Ended
December 31,
|
|
2014
|
2013
|
2014
|
2013
|
Revenues:
|
|
|
|
|
Milestones and license
fees
|
$
-
|
$ 730
|
$
-
|
$ 2,919
|
|
|
|
|
|
Total
revenues
|
-
|
730
|
-
|
2,919
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
15,498
|
8,918
|
46,425
|
39,248
|
General and
administrative
|
4,970
|
3,342
|
17,986
|
13,349
|
|
|
|
|
|
Total
operating expenses
|
20,468
|
12,260
|
64,411
|
52,597
|
|
|
|
|
|
Loss from
operations
|
(20,468)
|
(11,530)
|
(64,411)
|
(49,678)
|
Other
income:
|
|
|
|
|
(Loss) gain on
sale/disposal of assets
|
-
|
(1)
|
(4)
|
37
|
Deferred gain on real
estate
|
812
|
789
|
3,226
|
3,133
|
Investment income,
net
|
197
|
85
|
629
|
402
|
Other income,
net
|
15
|
15
|
18
|
16
|
|
|
|
|
|
Total
other income
|
1,024
|
888
|
3,869
|
3,588
|
|
|
|
|
|
Net loss
|
$ (19,444)
|
$ (10,642)
|
$ (60,542)
|
$ (46,090)
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
Basic and
Diluted
|
$ (0.26)
|
$ (0.16)
|
$ (0.81)
|
$ (0.69)
|
|
|
|
|
|
Shares used in the
calculation of net (loss) income per common share:
|
|
|
|
|
Basic and
Diluted
|
76,139
|
67,346
|
74,577
|
66,989
|
NEUROCRINE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
|
|
December 31,
2014
|
December 31,
2013
|
Cash, cash
equivalents and short-term marketable securities
|
$ 193,809
|
$ 145,739
|
Other current
assets
|
4,394
|
2,723
|
|
|
|
Total current
assets
|
198,203
|
148,462
|
Property and
equipment, net
|
2,507
|
1,771
|
Long-term
investments
|
37,492
|
-
|
Restricted
cash
|
4,831
|
4,443
|
|
|
|
Total assets
|
$ 243,033
|
$ 154,676
|
|
|
|
|
|
|
Current
liabilities
|
$ 15,664
|
$ 11,699
|
Long-term
liabilities
|
18,670
|
22,567
|
Stockholders'
equity
|
208,699
|
120,410
|
|
|
|
Total liabilities and
stockholders' equity
|
$ 243,033
|
$ 154,676
|
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SOURCE Neurocrine Biosciences, Inc.