SAN DIEGO, Calif., Oct 28, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the
quarter ended September 30, 2008. For the third quarter of 2008, the Company
reported a net loss of $17.7 million, or $(0.46) per share compared with a net
loss of $27.2 million, or $(0.72) per share, for the same period in 2007. For
the nine months, the Company reported a net loss of $59.8 million, or $(1.56)
per share, as compared to $79.3 million, or $(2.09) per share, for the same
period last year.
Revenues for the third quarter of 2008 were $0.8 million compared with
$0.5 million for the same period last year. Revenues for the nine months ended
September 30, 2008 were $3.2 million, compared with $0.7 million for the same
period in 2007. The increase in revenues is primarily due to revenues
recognized in 2008 under collaboration agreements with GlaxoSmithKline (GSK)
and Dainippon Sumitomo Pharma Co., Ltd.
Research and development expenses decreased to $13.0 million during the
third quarter of 2008 compared with $19.8 million for the same period in 2007.
For the nine months ended September 30, 2008, research and development
expenses were $43.4 million, compared to $57.6 million for the same period
last year. The decrease in research and development expenses is primarily due
to cost savings related to our restructuring in the fourth quarter of 2007.
General and administrative expenses were $3.5 million for the third
quarter of 2008 and $9.6 million during the same period last year. For the
nine months ended September 30, 2008, general and administrative expenses were
$16.4 million, compared to $26.7 million for the first nine months of 2007.
The reduction in general and administrative expenses is primarily due to cost
savings related to recent restructurings.
The Company's balance sheet on September 30, 2008 reflected total assets
of $207.7 million, including cash and investments of $118.2 million compared
with balances at December 31, 2007 of $276.7 million and $179.4 million,
respectively. The Company expects to end 2008 with approximately $100 million
in cash and investments.
"We are pleased with the progress of our GnRH program, especially the
recent positive results of our 603 study where once a day elagolix showed
profound efficacy with minimal impact on bone mineral density. We are also
nearing completion of the final preclinical studies of urocortin 2 to allow
for long-term Phase II clinical studies and our scientists have just recently
identified a clinical candidate from our VMAT2 development program for
movement disorders," said Kevin Gorman, Chief Executive Officer and President
of Neurocrine Biosciences. "While we are making great strides in advancing our
pipeline, we continue to prioritize expenditures and diligently manage our
cash burn."
R & D Pipeline Update
Neurocrine's clinical development group and corporate partners have five
programs in clinical development. Neurocrine scientists continue to supply
Neurocrine's pipeline to meet the Company-wide goal of bringing one new
compound into development each year.
Elagolix for Endometriosis
The Company recently 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 Food and Drug Administration (FDA).
The Company is also currently conducting two additional randomized
placebo-controlled Phase II clinical trials. The clinical endpoints for both
of these trials are a reduction in pelvic pain associated with endometriosis,
utilizing a scale proposed by the FDA. The first Phase II trial includes our
selected commercial formulation tablet in two doses, (150 mg and 250 mg); this
trial has completed randomization in 155 patients. The Company expects topline
results from the first three months of treatment in the first quarter of 2009.
The second trial is a four arm comparator trial of two doses of elagolix (150
mg and 250 mg), placebo or leuprolide depot. This trial is being conducted in
Central and Eastern Europe. Topline data from this 3-month double-blind trial
of approximately 180 patients should be available at the end of the first half
of 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). There are currently three distinct CRF compounds in clinical
development that have arisen out of the GSK collaboration. The compound
(876008) is in a Phase II "proof of concept" trial to evaluate its safety and
efficacy in patients with IBS. Approximately 130 patients meeting established
diagnostic criteria for IBS have been entered into this cross-over design
trial. The trial contains standard assessments of safety, tolerability and
pharmacokinetics. The clinical endpoints reflect change in symptom frequency
and severity and the data should be available later in 2008.
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) Continues Preclinical
Evaluation
Initiation of longer term (up to 72 hours in duration) Phase II clinical
trials of urocortin 2 are awaiting additional preclinical data. The Company
has identified five preclinical studies necessary to support the longer period
of infusion in the clinical program. Two of these five preclinical studies
were successfully completed by July 2008. The two completed studies were non-
GLP toxicology and safety assessment studies over 14 days of continuous
infusion in distinct species models. The favorable results of these studies
now await confirmation in the GLP preclinical studies anticipated later in
2008.
Indiplon Update
The Company met with the FDA in July for an end of review meeting related
to the December 12, 2007 approvable letter for indiplon capsules. The FDA
meeting focused on the three additional requirements outlined in the
approvable letter. After exchange of correspondence regarding meeting minutes,
the Company is awaiting the FDA's final version of these minutes to determine
the next course of action related to indiplon capsules.
Conference Call and Webcast Today at 5:00 p.m. Eastern Daylight Time
Neurocrine will hold a live conference call and webcast today at 5:00 p.m.
Eastern Daylight Time (2:00 p.m. Pacific Daylight Time). Participants can
access the live conference call by dialing 1-800-894-5910 (US) or 785-424-1052
(International) using the conference passcode 7NBIX2. 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 1-800-723-5154 (US) or 402-220-2661 (International) using the passcode
7NBIX2. The call will be archived for two weeks.
Neurocrine Biosciences, Inc. is a biopharmaceutical company focused on
neurological and endocrine diseases and disorders. Our product candidates
address some of the largest pharmaceutical markets in the world including
endometriosis, irritable bowel syndrome (IBS), anxiety, depression, pain,
diabetes, benign prostatic hyperplasia (BPH) and other neurological and
endocrine related diseases and disorders. Indiplon was licensed from DOV
Pharmaceutical, Inc. in 1998. 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 clinical programs include, but are not limited
to, risk that the Company's elagolix Phase II clinical trials will fail to
demonstrate that elagolix is safe and effective; risk that preclinical data
will indicate that urocortin 2 is not suitable for further clinical studies;
risk that the CRF1 receptor antagonist candidate's Phase II proof of concept
clinical studies will not support further clinical studies; and overall risk
that the Company's clinical candidates will not proceed to later stage
clinical trials. Risks associated with the Company's indiplon program
include, but are not limited to, risk that indiplon approval and subsequent
commercialization may be indefinitely delayed or never accomplished. 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, 2007 and report
on Form 10Q for the quarter ended June 30, 2008. 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 for per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 2008 2007
(unaudited) (unaudited)
Revenues:
Sponsored research and
development $32 $13 $48 $120
License fees and milestones 729 500 3,189 500
Grant Revenue - 27 9 72
Total revenues 761 540 3,246 692
Operating expenses:
Research and development 12,993 19,795 43,406 57,645
Sales, general and
administrative 3,472 9,571 16,423 26,695
Total operating expenses 16,465 29,366 59,829 84,340
Loss from operations (15,704) (28,826) (56,583) (83,648)
Other income and (expenses):
Interest income and expense,
net (93) 2,413 2,573 6,869
Other income and (expense),
net (1,914) (827) (5,749) (2,545)
Total other income (2,007) 1,586 (3,176) 4,324
Net loss $(17,711) $(27,240) $(59,759) $(79,324)
Net loss per common share:
Basic and diluted $(0.46) $(0.72) $(1.56) $(2.09)
Shares used in the calculation
of net loss per common share:
Basic and diluted 38,446 37,990 38,399 37,956
NEUROCRINE BIOSCIENCES, INC.
Condensed Consolidated Statements of Operations
(in thousands, except for per share data)
September December
30, 31,
2008 2007
(unaudited)
Cash, cash equivalents and marketable securities $96,949 $179,385
Other current assets 1,861 3,563
Total current assets 98,810 182,948
Property and equipment, net 77,309 82,598
Long-term investments 21,255 -
Restricted cash 6,441 6,399
Other non-current assets 3,918 4,709
Total assets $207,733 $276,654
Current liabilities $18,975 $29,907
Long-term liabilities 16,366 19,305
Leaseback financing obligation 108,745 108,745
Stockholders' equity 63,647 118,697
Total liabilities and stockholders' equity $207,733 $276,654
SOURCE Neurocrine Biosciences, Inc.
http://www.neurocrine.com