Neurocrine Biosciences Reports Fourth Quarter And Year End 2013 Results
PROVIDES UPDATE ON RAPIDLY ADVANCING PIPELINE AND FINANCIAL GUIDANCE FOR 2014
SAN DIEGO, Feb. 6, 2014
SAN DIEGO, Feb. 6, 2014 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:
NBIX) today announced its financial results for the quarter and year ended
December 31, 2013.
For the fourth quarter of 2013, the Company reported a net loss of $10.6
million, or $0.16 loss per share, compared to net income of $9.5 million, or
income of $0.14 per fully diluted share, for the same period in 2012. For the
year ended December 31, 2013, the Company reported a net loss of $46.1
million, or $0.69 loss per share, as compared to net income of $5.0 million,
or income of $0.08 per fully diluted share, for 2012. The change in operating
results from 2012 to 2013 is due to the successful completion of the sponsored
research and development phases of the Company's license agreements with both
AbbVie and Boehringer Ingelheim during 2012, as scheduled.
The Company's balance sheet at December 31, 2013 reflected total assets of
$154.7 million, including cash, investments and receivables of $146.8 million
compared with balances at December 31, 2012 of $196.0 million and $188.3
"During the last twelve months we have made great progress across our clinical
pipeline. Our VMAT2 program has recently successfully completed Phase II and
we are now looking forward to an End-of-Phase II meeting with the FDA, while
our partner AbbVie initiated the second of two Phase III trials of elagolix in
endometriosis as well as a Phase IIb uterine fibroids study," said Kevin C.
Gorman, President and CEO of Neurocrine Biosciences. "Looking forward to 2014
we see another year of significant growth with important data points for our
two lead clinical programs as well as several promising compounds that have
the potential to further strengthen our clinical pipeline."
Revenues for the fourth quarter of 2013 were $0.7 million, compared to $21.9
million for the same period in 2012. Revenues for the year ended December 31,
2013 were $2.9 million, compared with $53.1 million for the year ended
December 31, 2012. The decrease in revenue is due to the successful and timely
completion of the sponsored research and development phases of the Company's
license agreements during 2012.
Research and development expenses decreased to $8.9 million during the fourth
quarter of 2013, compared with $9.1 million for the same period in 2012. For
the year ended December 31, 2013, research and development expenses were $39.2
million, compared to $37.2 million for 2012. The year-over-year increase in
research and development expenses was primarily driven by Phase IIb
development expenses for the VMAT2 program, coupled with increased
compensation related costs, primarily due to share-based compensation.
2014 Financial Guidance
The Company expects to have a net cash burn of approximately $43 million to
$47 million in 2014. Expenses for 2014 should approximate $60 million to $64
million. The anticipated increase in expenses over 2013 levels is primarily
due to an increase in research and development efforts as well as higher
share-based compensation expense. Net loss for 2014 is expected to be $56
million to $61 million, or $0.82 to $0.90 loss per share based on 68 million
basic shares outstanding. The Company expects to end 2014 with approximately
$100 million in cash, investments and receivables.
AbbVie is currently conducting the Violet Petal Study, a Phase III study of
elagolix for endometriosis. 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 has also initiated the second Phase III study of elagolix for
endometriosis. 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.
AbbVie is also currently conducting a Phase IIb study of elagolix in uterine
fibroids. This study is assessing uterine blood loss in 520 women with heavy
uterine bleeding due to uterine fibroids.
The Company is utilizing the Kinect and Kinect 2 datasets to compile the
End-of-Phase II briefing package along with a proposed Phase III protocol for
submission to the FDA in the second quarter of 2014.
The Company also anticipates the End-of-Phase-II meeting for NBI-98854 in
tardive dyskinesia to be held with the FDA in the second quarter of 2014. Upon
completion of this meeting, the Company anticipates initiating the pivotal
Phase III program of NBI-98854 during the second half of 2014.
Additionally, the Company is conducting appropriate preclinical studies to
support the advancement of NBI-98854 into clinical trials for individuals
suffering from Tourette syndrome, and expects to open the investigational new
drug application for Tourette syndrome in 2014.
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 800-862-9098 (US) or 785-424-1051 (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 800-723-8184 (US) or 402-220-2668 (International) using the conference
ID: NBIX. The call will be archived for two weeks.
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
with respect to the Company's R & D pipeline include risk that elagolix, the
company's lead clinical program, will fail to demonstrate that elagolix is
safe and effective; risk that elagolix Phase III clinical trials will be
delayed for regulatory or other reasons; and risks associated with the
Company's dependence on corporate collaborators for Phase III development,
commercial manufacturing and marketing and sales activities. Similarly, the
Company faces risk that the clinical studies for NBI-98854, the company's
VMAT2 inhibitor candidate, will fail to demonstrate that NBI-98854 is safe and
effective and risk that NBI-98854 will not proceed to later stage clinical
trials. 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; and risk that
the Company's research programs will not identify pre-clinical candidates for
further development. With respect to the Company 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; risk 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; risk 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 annual report on Form 10-K for the year ended December 31, 2012
and quarterly reports on Form 10-Q for the quarters ended March 31, 2013, June
30, 2013 and September 30, 2013. 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)
Three Months Ended Year Ended
December 31, December 31,
2013 2012 2013 2012
Sponsored research and $ $ $ $
development - 13,959 - 18,897
Milestones and license fees 730 7,988 2,919 34,243
Total revenues 730 21,947 2,919 53,140
Research and development 8,918 9,097 39,248 37,163
General and administrative 3,342 3,311 13,349 13,437
Cease-use expense - 957 - 1,092
Total operating expenses 12,260 13,365 52,597 51,692
(Loss) income from operations (11,530) 8,582 (49,678) 1,448
(Loss) gain on sale/disposal (1) 7 37 32
Deferred gain on real estate 789 766 3,133 3,042
Investment income, net 85 130 402 489
Other income, net 15 5 16 14
Total other income 888 908 3,588 3,577
Net (loss) income $ (10,642) $ $ (46,090) $
Net (loss) income per common
Basic $ $ $ $
(0.16) 0.14 (0.69) 0.08
Diluted $ $ $ $
(0.16) 0.14 (0.69) 0.08
Shares used in the calculation
of net (loss) income per
Basic 67,346 66,406 66,989 65,619
Diluted 67,346 67,720 66,989 66,946
NEUROCRINE BIOSCIENCES, INC
CONDENSED CONSOLIDATED BALANCE SHEETS
Cash, cash equivalents and short-term $ 145,739 $ 173,013
Other current assets 2,723 16,251
Total current assets 148,462 189,264
Property and equipment, net 1,771 1,900
Long-term investments - 480
Restricted cash 4,443 4,335
Total assets $ 154,676 $ 195,979
Current liabilities $ 11,699 $ 15,646
Long-term liabilities 22,567 25,961
Stockholders' equity 120,410 154,372
Total liabilities and stockholders' equity $ 154,676 $ 195,979
SOURCE Neurocrine Biosciences, Inc.
Contact: Neurocrine Biosciences, Investor Relations, (858) 617-7600
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