Neurocrine Biosciences Reports Second Quarter 2009 Results
Revenues for the second quarter of 2009 and 2008 were
Research and development expenses decreased to
General and administrative expenses were
The Company's balance sheet on
"We are in a very good financial position with our burn well controlled
and within the guidance we gave at the beginning of the year," said
Pipeline Highlights
Elagolix Update
The Week 24 results of the recently completed Lilac Petal Study (0702) were released earlier today. This study assessed elagolix in subjects with confirmed endometriosis over a six-month period. The first three months of the study included three arms; elagolix 150 mg, elagolix 250 mg, and placebo. After the initial three months, the placebo arm was re-randomized into one of the two elagolix arms. These 24 Week results of the Lilac Petal Study again confirmed that elagolix has clinically meaningful efficacy coupled with a favorable safety profile.
The Tulip Petal Study (0703) has completed subject randomization in
Petal Study (0603) bone data were presented at the
Urocortin 2 Update
VMAT2 Update
The highly selective blockade of the Vesicular Monoamine Transporter 2
(VMAT2) with NBI-98854 should be of clinical benefit in patients with a
variety of CNS diseases, especially those with involuntary hyperkinetic
movements such as Tardive Dyskinesia. A Clinical Trial Application has been
approved by Health Canada and we will initiate a single ascending dose Phase 1
study in
Conference Call and Webcast
Neurocrine will hold a live conference call and webcast tomorrow morning,
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;
and 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, 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. 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 loss per share data)
Three Months Ended Six Months Ended
June 30, June 30,
-------- --------
2009 2008 2009 2008
---- ---- ---- ----
(unaudited) (unaudited)
Revenues:
Sponsored research
and development $3 $4 $20 $16
License fees and milestones 730 730 1,460 2,460
Grant revenue - - - 9
--- --- --- ---
Total revenues 733 734 1,480 2,485
Operating expenses:
Research and development 10,808 16,186 21,656 30,413
General and administrative 4,827 4,665 9,022 12,951
Cease use expense 941 - 5,769 -
--- --- ----- ---
Total operating expenses 16,576 20,851 36,447 43,364
Loss from operations (15,843) (20,117) (34,967) (40,879)
Other income and (expense):
Interest income and other
income 563 1,060 22 2,666
Interest expense - (1,914) - (3,835)
--- ------- --- -------
Total other income (expense)
net 563 (854) 22 (1,169)
Net loss $(15,280) $(20,971) $(34,945) $(42,048)
======== ======== ======== ========
Net loss per common share:
Basic and diluted $(0.39) $(0.55) $(0.90) $(1.10)
====== ====== ====== ======
Shares used in the calculation
of net loss per common share:
Basic and diluted 39,046 38,421 38,858 38,376
====== ====== ====== ======
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
June 30, December 31,
2009 2008
---- ----
(unaudited)
Current assets:
Cash and investments $52,767 $80,473
Other current assets 1,017 950
----- ---
Total current assets 53,784 81,423
Property and equipment, net 4,183 6,191
Long-term investments 21,242 21,057
Restricted cash 6,414 6,409
Other non-current assets 1,246 3,102
----- -----
Total assets $86,869 $118,182
======= ========
Current liabilities $33,017 $26,094
Long-term liabilities 46,504 55,314
Stockholders' equity 7,348 36,774
----- ------
Total liabilities and stockholders' equity $86,869 $118,182
======= ========
SOURCE:
CONTACT:
Neurocrine Biosciences Investor Relations, +1-858-617-7600
Web Site: http://www.neurocrine.com