Neurocrine Biosciences Reports Financial Results For Fourth Quarter and Year-End 2001
SAN DIEGO, Feb. 5 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the three and twelve months ended December 31, 2001. The Company reported a net loss of $14.6 million, or $0.53 per share for the fourth quarter 2001 as compared to a net loss of $6.5 million, or $0.29 per share for the same period last year. For the year ending December 31, 2001, the Company reported a loss of $36.9 million, or $1.42 per share as compared to a net loss of $28.8 million, or $1.30 per share in 2000.
Revenues for the fourth quarter of 2001 were $12.8 million compared with $6.4 million for the same period last year. This $6.4 million increase was primarily comprised of $4.3 million under the Taisho Pharmaceuticals (Taisho) collaboration which became effective in July 2000 and $2.1 million under the GlaxoSmithKline (GSK) collaboration, which was effective July 2001.
Revenues for the year ended December 31, 2001 were $41.2 million compared with $14.6 million for the year ended December 31, 2000. This $26.6 million increase was primarily comprised of $9.4 million from the Taisho collaboration and $19.2 million under the GSK collaboration.
Research and development expenses increased to $24.7 million for the fourth quarter of 2001 compared with $11.8 million for the respective period in 2000. For the twelve months ended December 31, 2001, research and development expenses were $74.3 million as compared to $40.2 million for the respective period in 2000. The increase in expenses reflects higher costs associated with expanding late stage clinical trials and the addition of scientific personnel and consultants needed to manage those activities. Clinical development and scientific consulting and collaborating expenses for quarter ended and year ended December 31, 2001 totaled $16.5 million and $44.8 million, respectively. During the same periods of 2000, those expenditures totaled $5.6 million and $16.6 million, respectively.
General and administration expenses increased to $3.6 million for the fourth quarter of 2001 compared with $3.0 million for the same period last year. For the twelve months ended December 31, 2001, general and administrative expenditures increased to $10.9 million compared with $10.0 million in 2000. The increase in administrative expenses during 2001 primarily resulted from the additional patent legal expenses and marketing research and the addition of administrative personnel.
The Company's balance sheet on December 31, 2001 reflected total assets of $346.4 million, including cash, cash equivalents, and marketable securities of $320.0 million compared with balances at December 31, 2000 of $186.0 million and $164.7 million, respectively. The increase in cash, cash equivalents, marketable securities and current receivables represents additional funding received from a public offering in December 2001, offset by funding of clinical and pre-clinical development projects throughout the year. Net proceeds received from the offering totaled $175.6 million.
"Having achieved our scientific and financial goals for 2001, we are in an excellent position to further advance our clinical programs in 2002," stated Paul W. Hawran, Executive Vice President and Chief Financial Officer for Neurocrine Biosciences. "In addition, with the conclusion of our successful follow-on public offering in December and the positive clinical results achieved with NBI-34060 for insomnia, we are now in a better position to maximize the shareholder value inherent with our insomnia program."
Commenting on a number of the clinical programs and the Company's performance, Hawran also noted the following:
-- NBI-34060 -- "Great strides were made in the insomnia program this
past year with positive results reported in over 500 subjects in
various Phase I & II safety pharmacokinetic and efficacy studies. In
the Phase I and Phase II studies completed this year, NBI-34060,
following nighttime and middle of the night dosing, showed next day
residual side effects similar to placebo and lower than currently
marketed sedative hypnotics. Positive results were also achieved in
adult and elderly patients with chronic and transient insomnia with
efficacy being achieved in both primary and secondary endpoints with
improvements in sleep quality and next day function. To date we have
completed 25 Phase I and Phase II clinical trials and enrolled
approximately 1,200 subjects in our insomnia program. We also reached
a major turning point in the history of the company with the
initiation of our first Phase III trial of NBI-34060 in approximately
500 patients with primary (chronic) insomnia."
-- NBI-6024 -- "Our collaboration with Taisho Pharmaceutical in NBI-6024
was expanded into a Phase IIb clinical program for Type I diabetes in
newly diagnosed adolescent and adult patients."
-- NBI-34041 -- "The largest collaboration in Neurocrine's history was
announced with GlaxoSmithKline in July for CRF receptor antagonists
including the further development of our Phase I compound. The
development of this new class of compounds for the treatment of
psychiatric, neurological and gastrointestinal diseases including
anxiety, depression and irritable bowel syndrome (IBS) is a novel
approach meeting a large unmet medical need. The first milestone
payment of $15.5M was received in October bringing the total received
in upfront fees and milestone payments to $25.5M."
-- NBI-42902 -- "Our gonadotropin releasing hormone (GnRH) program
advanced from preclinical to Phase I for an orally active antagonist
for women's health disorders and prostate cancer. Following the
Company's progressive development program for all compounds, we are
developing a back-up compound, which will undergo preclinical testing
this year. We were also successful in receiving an SBIR Phase II
grant from the NIH to further develop this program."
-- "Our senior management team was enhanced in October by the addition of
Henry Pan, M.D., Ph.D., F.A.C.C., as Executive Vice President of
Clinical Development and Chief Medical Officer. Dr. Pan brings with
him over 20 years of experience in the areas of pharmacology,
medicine, clinical pharmacology, and drug development with major
pharmaceutical companies. With his many years of experience both with
clinical development and ultimate filing of New Drug Application(s)
(NDA) with the FDA and regulatory agencies abroad, Henry's
contribution to our various clinical programs will be significant."
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, stroke, and certain female health disorders. 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 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 Neurocrine's drug candidates will not
successfully proceed through clinical trials or that later stage clinical
trials will not show that they are effective in treating humans;
determinations by regulatory and governmental authorities; dependence on
corporate collaborators who could terminate their relationships with the
Company at any time; 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 annual report filed on Form 10K for the year ended
December 31, 2000, as amended, the Company's quarterly reports filed on
Form 10Q for the first three quarters of 2001 and its most recent registration
statement, as filed with the Securities and Exchange Commission, 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 Twelve Months Ended
December 31, December 31,
2001 2000 2001 2000*
Revenues:
Sponsored research and
development $5,932 $1,938 $16,880 $6,881
License and option fees 603 192 1,562 2,345
Milestones 5,875 4,000 21,375 4,000
Grant income and other
revenues 423 312 1,425 1,362
Total revenues 12,833 6,442 41,242 14,588
Operating expenses:
Research and development 24,684 11,823 74,267 40,227
General and administrative 3,553 3,032 10,857 9,962
Total operating expenses 28,237 14,855 85,124 50,189
Income (loss) from
operations (15,404) (8,413) (43,882) (35,601)
Other income and (expenses):
Interest and other income,
net 920 1,755 6,662 6,048
Other income and expenses, net (6) 121 430 1,047
Income (loss) before taxes (14,490) (6,537) (36,790) (28,506)
Income taxes 120 -- 120 302
Net income (loss) $(14,610) $(6,537) $(36,910) $(28,808)
Income (loss) per common
share:
Basic $(0.53) $(0.29) $(1.42) $(1.30)
Shares used in the calculation
of income (loss) per
common share:
Basic 27,371 22,789 26,028 22,124
Balance Sheet
(in thousands)
December 31, December 31,
2001 2000
(unaudited)
Cash, cash equivalents and marketable securities $319,982 $164,670
Other current assets 11,533 7,735
Total current assets 331,515 172,405
Property and equipment, net 12,276 11,300
Other assets 2,559 2,257
Total assets $346,350 $185,962
Current liabilities $24,761 $14,959
Long-term liabilities 11,196 7,795
Stockholders' equity 310,393 163,208
Total liabilities and stockholders' equity $346,350 $185,962
* During the fourth quarter of 2000, the Company adopted SEC Staff
Accounting Bulletin 101 (SAB 101), Revenue Recognition in Financial
Statements. The result of the adoption of SAB 101 was to reduce
recognition of previously reported license fee revenues by
$2.7 million.These revenues were deferred and will be recognized as
income, ratably over the estimated lives of the respective agreements.
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SOURCE Neurocrine Biosciences, Inc.
Web site: http: //www.neurocrine.com
CONTACT: Claudia Jones or Paul Hawran of Neurocrine Biosciences, Inc., +1-858-658-7600