Neurocrine Biosciences Reports Fourth Quarter And Year End 2012 Results

   Neurocrine Biosciences Reports Fourth Quarter And Year End 2012 Results

ANNOUNCES 2013 CLINICAL MILESTONES FOR RAPIDLY MATURING R&D PIPELINE

PR Newswire

SAN DIEGO, Feb. 8, 2013

SAN DIEGO, Feb. 8, 2013 /PRNewswire/ --Neurocrine Biosciences, Inc. (NASDAQ:
NBIX) today announced its financial results for the quarter and year ended
December 31, 2012.

For the fourth quarter of 2012, the Company reported net income of $9.5
million, or $0.14 per fully diluted share, compared to net income of $1.3
million, or $0.02 per fully diluted share, for the same period in 2011. For
the year ended December 31, 2012, the Company reported net income of $5.0
million, or $0.08 per fully diluted share, as compared to net income of $37.6
million, or $0.67 per fully diluted share, for 2011. One-time milestone
payments of $30.0 million during 2011 were primarily responsible for the
change in operating results year over year.

The Company's balance sheet at December 31, 2012 reflected total assets of
$196.0 million, including cash, investments and receivables of $188.3 million
compared with balances at December 31, 2011 of $138.4 million and $131.7
million, respectively. During January 2012, the Company completed a public
offering of approximately 10.9 million shares of common stock that resulted in
net proceeds of approximately $83.0 million.

"During 2012 we continued to perform to financial plan and were successful in
moving our VMAT2 tardive dyskinesia program forward, as well as AbbVie
advancing the elagolix endometriosis and uterine fibroids programs," said
Kevin C. Gorman, President and CEO of Neurocrine Biosciences. "Looking to 2013
we will have two Phase IIb readouts for our VMAT2 program, expect AbbVie to
progress elagolix into Phase IIb in uterine fibroids, and we anticipate one
additional program entering the clinic, resulting in a very productive year."

Revenues for the fourth quarter of 2012 were $21.9 million, compared to $11.1
million for the same period in 2011. The $10.8 million increase in revenue is
primarily due to higher revenues under the Company's elagolix collaboration
agreement. Revenues for the year ended December 31, 2012 were $53.1 million,
compared with $77.4 million for 2011. The $24.3 million decrease in revenue is
primarily due to $30 million in milestones achieved under the Company's
elagolix collaboration agreement during the third quarter of 2011.

Research and development expenses increased to $9.1 million during the fourth
quarter of 2012 compared with $8.0 million for the same period in 2011. For
the year ended December 31, 2012, research and development expenses were $37.2
million, compared to $31.0 million for 2011. The increase in research and
development expenses is primarily driven by Phase IIb development expenses for
the VMAT2 program, coupled with increased compensation related costs,
primarily due to equity based compensation.

General and administrative expenses increased to $3.3 million during the
fourth quarter of 2012 compared with $2.7 million for the same period last
year. For the year ended December 31, 2012, general and administrative
expenses were $13.4 million, compared to $12.5 million for 2011. The increase
in year-to-date general and administrative expenses is primarily related to
higher equity based compensation costs.

2013 Financial Guidance

The Company expects to have a net cash burn from operations of approximately
$50 to $55 million in 2013. Revenue is expected to approximate $3 million
which consists solely of the amortization of up-front license fees. Expenses
for 2013 should approximate $55 to $60 million. Net loss for 2013 is expected
to be $50 to $55 million, or $0.75 to $0.83 loss per share based on 66.5
million basic shares outstanding. The Company expects to end 2013 with in
excess of $130 million in cash, investments and receivables.

Pipeline Highlights

Elagolix Update

AbbVie is currently conducting the initial Phase III study of elagolix for
endometriosis, the Violet Petal Study. The study is a 24-week, multinational,
randomized, double-blind, placebo-controlled study designed to evaluate the
safety and efficacy of elagolix in 875 women, age 18 to 49, with moderate to
severe endometriosis-associated pain. Approximately 160 sites in the United
States, Puerto Rico and Canada are conducting this study.

AbbVie is also currently conducting a Phase II study of elagolix for uterine
fibroids to assess blood loss in women with heavy uterine bleeding due to such
fibroids. AbbVie expects a Phase IIb study in uterine fibroids to commence in
2013.

VMAT2 Update

The Company is currently conducting two Phase IIb studies of its VMAT2
inhibitor NBI-98854.

The Kinect Study is a 120 subject, placebo-controlled, double-blind, parallel
design, multiple dose, 12-week study assessing six-week dosing of NBI-98854
against placebo, followed by six weeks of open-label treatment with NBI-98854.
The primary endpoint is the Abnormal Involuntary Movement Scale (AIMS) at the
end of the first six weeks of dosing. The study will also incorporate a
capsule formulation of NBI-98854. Top-line data from the placebo-controlled
portion of this study is expected in the second quarter of 2013.

The Kinect 2 Study is a 90 subject, placebo-controlled, double-blind, parallel
design, multiple dose, six-week study assessing NBI-98854 against placebo. The
primary endpoint is the AIMS at the end of the six weeks of dosing. Top-line
data from this placebo-controlled study is expected in the third quarter of
2013.

Additionally, the Company is conducting appropriate preclinical studies to
support the advancement of NBI-98854 into clinical trials for individuals
suffering from Tourette's syndrome.

The Company anticipates and end-of-phase-II meeting for NBI-98854 in tardive
dyskinesia to be held with the FDA in the fourth quarter of 2013.

Conference Call and Webcast Today at 8:00 AM 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 800-388-6197 (US) or 402-220-1115 (International) using the conference
ID: NBIX. The call will be archived for two weeks.

Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on
neurological and endocrine-related diseases and disorders. Our product
candidates address some of the largest pharmaceutical markets in the world,
including endometriosis, tardive dyskinesia, uterine fibroids, stress-related
disorders, pain, diabetes, insomnia, and other neurological and
endocrine-related diseases and disorders. 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
Company overall. Specifically, the risks and uncertainties the Company faces
with respect to the Company's R & D pipeline include risk that the ongoing
Phase III endometriosis clinical trial for elagolix, the most advanced
clinical program in the Company's pipeline, will fail to support the
additional Phase III clinical trial required for regulatory approval; risk
that the elagolix Phase III program overall will encounter delays for
regulatory or other reasons; risk that the elagolix Phase III clinical program
will fail to demonstrate that elagolix is safe and effective for the treatment
of endometriosis or support filings for regulatory approval; risk that the
uterine fibroid elagolix clinical trials will fail to demonstrate that
elagolix is safe and effective for the treatment of uterine fibroids; and
risks associated with the Company's dependence on corporate collaborators for
Phase III development, commercial manufacturing and marketing and sales
activities. In addition, the Company faces risks and uncertainties with
respect to the rest of the Company's R & D pipeline including risk that the
Company's clinical candidates will not be found to be safe and effective; risk
that NBI-98854 will not proceed to later stage clinical trials and risk that
the Company's clinical trials will fail to demonstrate that NBI-98854 is safe
and effective; and risk that the Company's research programs will not identify
pre-clinical candidates for further development. With respect to its pipeline
overall, the Company faces risk that it will be unable to raise additional
funding required to complete development of all of its product candidates;
risk relating to the Company's dependence on contract manufacturers for
clinical drug supply; risks associated with the Company's dependence on
corporate collaborators for commercial manufacturing and marketing and sales
activities; uncertainties relating to patent protection and intellectual
property rights of third parties; risks and uncertainties relating to
competitive products and technological changes that may limit demand for the
Company's products; and the other risks described in the Company's report on
Form 10-K for the year ended December 31, 2011 and Form 10-Q for the quarter
ended September 30, 2012. Neurocrine undertakes no 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      Year Ended

                               December 31,            December 31,
                               2012          2011      2012        2011
Revenues:
Sponsored research and         $   13,959 $      $        $   
development                                  1,873    18,897      10,462
Milestones and license fees    7,988         9,237     34,243      66,951
Total revenues                 21,947        11,110    53,140      77,413
Operating expenses:
Research and development       9,097         8,002     37,163      30,951
General and administrative     3,311         2,668     13,437      12,458
Cease-use expense              957           (7)       1,092       82
Total operating expenses       13,365        10,663    51,692      43,491
Income from operations         8,582         447       1,448       33,922
Other income:
Gain on sale/disposal of       7             58        32          242
assets
Deferred gain on real estate   766           744       3,042       2,953
Investment income, net         130           77        489         418
Other income, net              5             5         14          36
Total other income             908           884       3,577       3,649
Net income                     $          $      $       $   
                               9,490        1,331    5,025       37,571
Net income per common share:
Basic                          $         $     $      $     
                               0.14         0.02     0.08        0.68
Diluted                        $         $     $      $     
                               0.14         0.02     0.08        0.67
Shares used in the calculation
of net income per common
share:
Basic                          66,406        55,259    65,619      55,176
Diluted                        67,720        56,461    66,946      56,347







NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
                                             December31,     December31,

                                             2012             2011
Cash, cash equivalents and short-term        $    173,013  $    129,103
marketable securities
Other current assets                         16,251           3,373
Total current assets                         189,264          132,476
Property and equipment, net                  1,900            1,586
Long-term investments                        480              —
Restricted cash                              4,335            4,306
Total assets                                 $    195,979  $    138,368
Current liabilities                          $     15,646 $     47,110
Long-term liabilities                        25,961           31,177
Stockholders' equity                         154,372          60,081
Total liabilities and stockholders' equity   $    195,979  $    138,368

SOURCE Neurocrine Biosciences, Inc.

Website: http://www.neurocrine.com
Contact: Investor Relations, +1-858-617-7600