Tuesday July 31, 7:30 am Eastern Time
Press Release
SOURCE: Neurocrine Biosciences, Inc.
Neurocrine Biosciences Reports Second Quarter 2001
Results; Company Expands Clinical Development
Efforts
SAN DIEGO, July 31 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX -
news) today announced its financial results for the second quarter ended June 30, 2001. The
Company reported a net loss of $13.3 million or $0.52 per share and $24.8 million or $0.97
per share for the three and six months ended June 30, 2001, respectively. These results
compare with $5.2 million or $0.24 per share and $11.2 million or $0.51 per share for the
respective periods in 2000. The Company's balance sheet on June 30, 2001 reflected total
assets of $163.6 million, including cash, cash equivalents, marketable securities and current
receivables of $146.3 million compared with balances at December 31, 2000 of $186.0
million and $170.6 million, respectively. The decline in cash, cash equivalents, marketable
securities and current receivables represent increased funding of current period clinical
development projects.
Revenues for the second quarter of 2001 were $3.3 million compared with $2.9 million for
the same period last year. Revenues for the six-months ended June 30, 2001 were $6.8
million compared with $5.7 million in 2000. The net increase in revenues was primarily the
result of fees received related to the July 2000 Taisho collaboration offset by a decline in
revenues resulting from the completion of the sponsored research portion of the collaboration
with Janssen Pharmaceutical, N.V.
Research and development expenses increased to $16.1 million for the second quarter of
2001 compared with $8.1 million for the respective period in 2000. For the six-months
ended June 30, 2001, research and development expenses were $31.3 million as compared
to $15.9 million for the comparable period in 2000. The increase in expenses reflects higher
costs associated with expanding clinical development activities and the addition of scientific
personnel as the Company advances its drug candidates through late stage clinical testing.
General and administrative expenses increased to $2.9 million for the second quarter 2001
compared with $2.2 million for the same period last year. For the six-months ended June 30,
2001 general and administrative expenditures totaled $5.2 million compared to $4.4 million in 2000. The increase resulted from
additional administrative personnel expenses, primarily wages and scientific personnel recruiting and relocation costs, and
professional service expenses to support the Company's expanded clinical development efforts and legal expenses to support
and maintain the Company's growing patent portfolio.
Commenting on the Company's performance, Paul W. Hawran, Executive Vice President and Chief Financial Officer for
Neurocrine Biosciences stated, ``We have made enormous progress this year in advancing our five therapeutic products
through the clinic as part of our long-term strategy to develop multiple products for multiple key therapeutic indications. The
higher second quarter operating expenses are primarily the result of increased clinical testing compared to a year ago. During
this quarter we completed enrollment in two Phase II trials with NBI-34060 for chronic and transient insomnia. We are
continuing to enroll patients in a Phase II dose ranging study with NBI-34060 in elderly patients with chronic insomnia and we
recently initiated a Phase II study with NBI-34060-MR (modified release formulation). We also increased our efforts toward
advanced clinical development, ramping up for the initiation and implementation of pivotal Phase III studies for two of
Neurocrine's products: NBI-34060 for insomnia planned to begin by the fourth quarter of 2001 and NBI-3001 for
glioblastoma planned to begin by the end of 2001. In addition we are conducting numerous ongoing Phase I and Phase II safety
and dose finding studies to support our product registrations. The increased clinical expenses were partially offset by revenues
from Neurocrine's collaboration with Taisho Pharmaceuticals Co. LTD for the development of NBI-6024 for diabetes.''
Neurocrine recently signed the largest deal in the Company's history. Neurocrine and GlaxoSmithKline signed a worldwide
research, development and commercialization agreement for CRF Receptor Antagonists (CRF-R1 and CRF-R2), an entirely
new class of compounds to treat psychiatric, neurological and gastrointestinal diseases including anxiety, depression and
irritable bowel syndrome (IBS). Neurocrine's CRF R1 Antagonist, NBI 34041, is currently in Phase I development for anxiety
and depression. Under the terms of the agreement, Neurocrine and GlaxoSmithKline will conduct a collaborative research
program for up to five years to identify and develop CRF-R antagonist compounds. The collaboration also includes worldwide
development and commercialization of NBI-34041 as well as back-up candidates resulting from the joint research program.
Neurocrine will receive upfront fees and early milestone payments totaling $25.5 million and annual fees. In addition,
Neurocrine is eligible to receive milestone payments as compounds progress through the research and development process,
royalties on any future product sales and co-promotion rights in the United States.
Additional Clinical and Research Progress Reported:
-- Neurocrine recently reported dose related positive efficacy results
with all four doses of NBI-34060 in a Phase II study in 59 enrolled
patients with Chronic Insomnia. Neurocrine will select final doses
for the upcoming pivotal Phase III clinical studies.
-- Neurocrine plans to announce the results of the Phase II clinical
trial with NBI-34060 in 339 patients with transient insomnia in Q3
this year.
-- Neurocrine continued enrollment in its Phase I/II clinical trial with
NBI-3001 for glioblastoma and is on track to complete this study and
initiate pivotal Phase III studies later this year. It is also
anticipated that Phase I studies for its use in renal, breast and
non-small cell lung cancer will start in Q3 this year.
-- Neurocrine has also completed enrollment in four Phase I studies with
NBI-6024 for the treatment of diabetes and plans to start a
large-scale Phase II program by year end.
-- An orally active GnRH antagonist development candidate has been
selected for the treatment of endometriosis and fibroids and is
expected to enter Phase I studies by Q4.
-- Neurocrine announced that proprietary small molecule CRF R1
antagonists demonstrated robust efficacy in preclinical models of IBS,
a third stress-related indication for CRF R1 antagonists. Neurocrine
collaborators from UCLA and the University of Oklahoma presented data
demonstrating efficacy in preclinical studies at the Digestive
Diseases Week (DDW) meeting.
-- Neurocrine is currently conducting Phase I development with NBI-34041
for anxiety and depression and is preparing to initiate a multi-dose
Phase I clinical trial. This program will now be funded by
Neurocrine's recently announced collaboration with GlaxoSmithKline.
Additional Technology Collaboration Signed:
-- Neurocrine and MediChem Life Sciences entered into a two-year
collaborative agreement in proteonomics for new drug development.
Under the terms of the agreement, MediChem will crystallize and
determine high-resolution 3D structures of specific G-protein coupled
receptors (GPCRs) such as CRF receptors.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases
and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia,
anxiety, depression, malignant brain tumors and peripheral cancers, diabetes, multiple sclerosis, irritable bowel syndrome,
eating disorders, pain, and certain female health disorders. Neurocrine Biosciences, Inc. news releases are available through the
Company's website via the Internet at neurocrine.com.
In addition to historical facts, this press release contains 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 development programs and business and finances including,
but not limited to, risk that the products of Neurocrine's development programs will not successfully proceed into clinical trials,
will not be determined to be safe in early clinical trials or that later stage clinical trials will not show that they are effective in
treating humans; determinations by regulatory and governmental authorities; uncertainties relating to patent protection and
intellectual property rights of third parties; impact of competitive products and technological changes; availability of capital and
cost of capital; and other material risks. A more complete description of these risks can be found in the Company's Form 10K
for the year ended December 31, 2000 and the current form 10Q each of which should be read before making any investment
in Neurocrine common stock. Neurocrine undertakes no obligation to update the statements contained in this press release
after the date hereof.
NEUROCRINE BIOSCIENCES, INC.
Statement of Operations
(unaudited; in thousands except for loss per share data)
Three Months Ended Six Months Ended
June 30, June 30,
2001 2000 2001 2000
Revenues:
Sponsored research
and development $2,879 $1,534 $5,844 $3,056
Sponsored research
and development from
related party -- -- -- --
Options 229 1,000 458 2,000
Milestones -- -- -- --
Grant income and
other revenues 220 408 514 664
Total revenues 3,328 2,942 6,816 5,720
Operating expenses:
Research and
development 16,066 8,134 31,256 15,905
General and
administrative 2,854 2,188 5,231 4,421
Total operating
expenses 18,920 10,322 36,487 20,326
Loss from operations (15,592) (7,380) (29,671) (14,606)
Other income and
(expenses):
Interest and other
income, net 2,034 1,409 4,567 2,923
Other income and
expenses, net 214 779 297 644
Loss before taxes (13,344) (5,192) (24,807) (11,039)
Income taxes $-- $200
Net loss $(13,344) $(5,192) $(24,807) $(11,239)
Loss per common
share:
Basic and diluted $(0.52) $(0.24) $(0.97) $(0.51)
Shares used in the
calculation of loss
per common share:
Basic and diluted 25,498 21,897 25,452 21,834
Balance Sheet
(in thousands)
June 30, December 31,
2001 2000
(unaudited)
Cash, cash equivalents and marketable
securities $144,308 $164,670
Other current assets 4,531 7,735
Total current assets 148,839 172,405
Property and equipment, net 12,141 11,300
Other assets 2,644 2,257
Total assets $163,624 $185,962
Current liabilities $12,847 $14,959
Long-term liabilities 7,912 7,795
Stockholders' equity 142,865 163,208
Total liabilities and
stockholders' equity $163,624 $185,962
* Prior period information includes reclassifications to conform to
current financial presentations.
SOURCE: Neurocrine Biosciences, Inc. |
