Neurocrine Biosciences Reports Fourth Quarter and Year-End 2008 Results
Revenues for the fourth quarter of 2008 were
Research and development expenses were
Sales, general and administrative expenses were
During the fourth quarter of 2008, the Company amended the lease agreement
for its two building campus. Under the amendment, the Company vacated the
front office building and established a mechanism for the Company to reduce
its fixed costs related to the front office building. As a result of vacating
the front office building, the Company incurred a "cease-use" expense of
Additionally, the Company terminated its option to repurchase the
buildings at a predetermined inflationary cost. The forfeiture of this
repurchase option resulted in the Company removing a
The Company's balance sheet at
"During 2008, we performed to plan from both a scientific and financial
standpoint. We completed the GnRH 603 study with outstanding statistically and
clinically significant results. Additionally, both the 702 and 703 studies in
GnRH were initiated and are on track. The preclinical work for urocortin 2 was
successfully completed, and we advanced another compound, a VMAT2 inhibitor,
now ready for clinical development. We pushed all these initiatives forward
while meeting our main financial goal to end 2008 with over
2009 Financial Guidance
Exclusive of any new partnering agreements, the Company expects to have a
cash burn in 2009 of approximately
Pipeline Highlights
The Company's clinical development group and corporate partners are advancing its lead programs through development. Neurocrine scientists continue to build the Company's pipeline to meet the Company-wide goal of bringing one new compound into development each year.
GnRH Antagonists in Expanded Phase II Clinical Trials for Endometriosis
Elagolix for Endometriosis
During 2008, the Company announced the positive safety and efficacy results from the completed 6-month treatment phase of its Phase IIb clinical trial (PETAL Study) using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix.
The primary endpoint, percent change from baseline in mean bone mineral
density (BMD) demonstrated elagolix did not induce significant bone loss over
the six month treatment period. Additionally, elagolix also met the secondary
endpoints of improvement in endometriosis symptoms using several different
scales for endometriosis pain. The 6-month results from this study, together
with data from the other Phase II studies, will be the basis for securing
agreement on a registration plan with the
The Company is also currently conducting two additional randomized
placebo-controlled Phase IIb clinical trials. The primary clinical endpoint
for both of these trials is a reduction in pelvic pain associated with
endometriosis, utilizing a Numeric Rating Scale. The first Phase IIb trial
includes the Company's selected commercial formulation tablet in two once
daily doses, (150 mg and 250 mg); this trial has completed the initial
three-month placebo controlled dosing regimen and continues with an additional
three-months of elagolix treatment. The Company will report top-line results
from the first three months of treatment at the end of the first quarter of
2009. The second trial is a four arm comparator trial of two once daily doses
of elagolix (150 mg and 250 mg), placebo or leuprolide depot. This trial is
being conducted in
The Company expects to hold an end of Phase II meeting with the FDA in late 2009.
Neurocrine is also investigating the potential of certain GnRH antagonists in treating other hormone-dependent diseases in men's and women's health.
Corticotropin Releasing Factor (CRF1) Receptor Antagonists for Anxiety/Depression and IBS
The CRF collaboration between Neurocrine and GSK has identified multiple unique high affinity and selective antagonists for the CRF1 receptor that are currently in clinical development for mood disorders and irritable bowel syndrome (IBS).
In a double-blind, randomized, placebo controlled, multiple dose study to evaluate the safety and efficacy of the CRF1 receptor antagonist, 876008, in approximately 130 patients with IBS, no statistically significant differences were observed in the key efficacy endpoints between 876008 and placebo.
GSK has advanced a novel lead CRF1 receptor antagonist compound, 561679, into a Phase II trial in patients with major depressive disorder. Enrollment of approximately 150 subjects is anticipated in this 6-week randomized, double-blind, placebo-controlled trial.
In addition to the two compounds listed above, GSK has also successfully completed a Phase I single dose-escalating clinical trial with a third CRF1 compound, 586529, for the treatment of anxiety and depression.
Urocortin 2 for Congestive Heart Failure (CHF) Completes Preclinical Evaluations
In
Vesicular Monoamine Transporter 2 Inhibitor (VMAT2)
VMAT2 is a protein concentrated in the human brain that is essential for the transmission of nerve impulses between neurons. The Company has identified a highly selective VMAT2 inhibitor that is effective in regulating the levels of dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines thereby reducing the likelihood of "off target" side effects. This clinical candidate should be effective in the management of hyperkinetic movement disorders characterized by involuntary bodily movements as seen in patients suffering from Tardive Dyskinesia, and Huntington's disease. Additionally, the modulation of dopamine pathways may also be useful for patients suffering from schizophrenia.
Indiplon Update
The Company met with the FDA in July for an end of review meeting related
to the
Conference Call and Webcast Today at
Neurocrine will hold a live conference call and webcast today at
If you are unable to attend the Webcast and would like further information
on this announcement please contact the
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 GnRH program, R & D
pipeline and Company overall. Specifically, the risks and uncertainties the
Company faces with respect to the Company's GnRH program include risk that the
elagolix clinical trials will fail to demonstrate that elagolix is safe and
effective; risk that elagolix will not proceed to later stage clinical trials;
risks associated with the Company's dependence on corporate collaborators for
development, commercial manufacturing and marketing and sales activities. In
addition, the Company faces risks and uncertainties with respect to the
Company's R & D pipeline including risk that the Company's urocortin 2, CRF1
receptor antagonist, and VMAT2 clinical candidates will not proceed to later
stage clinical trials, and risk that the Company's research programs will not
identify pre-clinical candidates for further development. The Company also
faces risk that the Company may be unable to obtain FDA approval for indiplon
commercialization in the near future or at all. 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
NEUROCRINE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(in thousands, except for per share data)
Three Months Ended Twelve Months Ended
December 31, December 31,
2008 2007 2008 2007
(unaudited) (unaudited)
Revenues:
Sponsored research and
development $- $19 $47 $139
License fees and milestones 729 486 3,919 986
Grant Revenue - 27 9 99
Total revenues 729 532 3,975 1,224
Operating expenses:
Research and development 11,885 24,340 55,291 81,985
Sales, general and
administrative 3,817 10,786 20,240 37,481
Cease-use expense 15,742 - 15,742 -
Prepaid royalty write-off - 94,000 - 94,000
Total operating expenses 31,444 129,126 91,273 213,466
Loss from operations (30,715) (128,594) (87,298) (212,242)
Other income and (expenses):
Gain on sale of fixed assets 3,494 3 3,578 129
Interest income and expense,
net (1,633) 616 (4,893) 4,814
Total other income 1,861 619 (1,315) 4,943
Net loss $(28,854) $(127,975) $(88,613) $(207,299)
Net loss per common share:
Basic and diluted $(0.75) $(3.35) $(2.30) $(5.45)
Shares used in the calculation of
net loss per common share:
Basic and diluted 38,599 38,165 38,449 38,009
NEUROCRINE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(in thousands, except for per share data)
December 31, December 31,
2008 2007
(unaudited)
Cash, cash equivalents and marketable
securities $80,473 $179,385
Other current assets 950 3,563
Total current assets 81,423 182,948
Property and equipment, net 6,191 82,598
Long-term investments 21,057 -
Restricted cash 6,409 6,399
Other non-current assets 3,102 4,709
Total assets $118,182 $276,654
Current liabilities $26,094 $29,907
Long-term liabilities 55,314 19,305
Leaseback financing obligation - 108,745
Stockholders' equity 36,774 118,697
Total liabilities and stockholders' equity $118,182 $276,654
SOURCE:
CONTACT:
+1-858-617-7600
Web Site: http://www.neurocrine.com