EXHIBIT 99.1
FOR IMMEDIATE RELEASE
Contact at Neurocrine Biosciences
Claudia Jones or Elizabeth Foster
(858) 658-7600
NEUROCRINE BIOSCIENCES REPORTS FIRST QUARTER 2004 RESULTS
COMPANY WILL HOST A CONFERENCE CALL AND WEBCAST TODAY,
MONDAY, MAY 3, 2004
San Diego, CA, May 3, 2004 - Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today
announced its financial results for the quarter ended March 31, 2004. For the
first quarter, the Company reported a net loss of $12.4 million, or $0.35 per
share compared with a net loss of $13.4 million, or $0.43 per share, for the
same period in 2003.
Revenues for the first quarter of 2004 were $16.9 million compared with $37.7
million for the respective period last year. The decrease in revenues of $20.8
million is primarily due to lower sponsored development revenue associated with
the winding down of the indiplon registration clinical program, offset by
licensing fee revenue reflected in the collaboration agreement with Pfizer, Inc
(Pfizer). During the first quarter of 2004, under the Pfizer collaboration
agreement, the Company recognized $4.0 million in the form of sponsored
development funding and an additional $10.9 million resulting from license fees.
During the first quarter of 2003 the Company realized $29.3 million from Pfizer
for sponsored development funding and an additional $5.1 million recognition of
license fees.
Research and development expenses decreased to $26.4 million for the first
quarter 2004 compared with $48.3 million for the respective period in 2003. This
$21.9 million decrease in research and development expenses is primarily due to
our Phase III program for indiplon that is nearing completion, offset by
increased research and development expenses in other programs.
General and administrative expenses increased to $5.3 million for the first
quarter 2004 compared with $4.7 million during the same period last year. The
increase in expenses from 2003 to 2004 resulted primarily from the addition of
administrative personnel to support the expanding research and development
activities, marketing and business development.
The Company's balance sheet on March 31, 2004 reflected total assets of $577.3
million, including cash, cash equivalents, marketable securities of $371.7
million compared with balances at December 31, 2003 of $555.0 million and $453.2
million, respectively. The decrease in cash balances resulted primarily from the
purchase of the indiplon royalty stream from Wyeth for $50.0 million cash
combined with the operating loss for the quarter.
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"As we wind down our Phase III clinical registration program for indiplon, we
will focus on the completion of data integration and dose selection for market
differentiation to support submission of our New Drug Applications (NDAs) for
indiplon which will include data from 69 clinical trials and approximately 7,000
subjects making this one of the largest, most robust clinical programs in the
sleep class," said Paul Hawran, Executive Vice President and Chief Financial
Officer of Neurocrine Biosciences. "Upon filing, our efforts will then
concentrate on building and developing our sales and marketing infrastructure to
support our research and development programs and to prepare for the launch and
commercialization of indiplon as we continue our transition to a more fully
integrated pharmaceutical company," added Hawran.
FIRST QUARTER HIGHLIGHTS
INDIPLON
Neurocrine completed and reported positive results in seven Phase III clinical
trials for indiplon:
Immediate Release Formulation:
- Two week efficacy and safety trial with two dose levels in 360
elderly patients
- "RESTFUL" long term, three month efficacy and safety trial
with two dose levels in 700 adult patients
- Six month safety trial with two dose levels in 120 elderly
patients
Modified Release Formulation:
- One night efficacy and safety trial with two dose levels in
325 adult subjects
- Two week efficacy and safety trial in 220 elderly patients
- "SLEEP" long term, three month efficacy and safety trial with
two dose levels in 740 adult patients
- 35 day efficacy and safety trial with two dose levels in 340
elderly patients
Based on the results of the Phase III clinical trials, the Company is currently
assembling the documentation to submit an NDA. The objectives and timing of the
filing for both NDAs will be announced after Neurocrine and Pfizer finalize the
strategy for market differentiation including dose selection, product
positioning and labeling.
GNRH FOR WOMEN'S HEALTH DISORDERS AND PROSTATE CANCER
The second generation GnRH candidate, NBI-56418, for endometriosis and uterine
fibroids is currently completing Phase I clinical studies. The current study is
a Phase I combination single dose, followed by multiple escalating doses in
approximately 50 pre-menopausal women. The study is assessing the safety,
pharmacokinetics (PK), and pharmcodynamics (PD) of the compound.
- Completed the first cohort of subjects for the multiple dosing
portion of the trial and escalating to higher doses.
- Initiated Phase I single dose in normal healthy males.
- Initiation of Phase IIa studies are planned to begin before
the end of the year.
- A back-up compound is scheduled to enter a Phase I trial
during the third quarter.
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CRF FOR STRESS RELATED DISORDERS
The Corticotropin Releasing Factor (CRF) program (CRF small molecule antagonist)
partnered with GlaxoSmithKline (GSK) has identified multiple unique preclinical
compounds that are in various stages of development for anxiety, depression and
irritable bowel syndrome (IBS).
UROCORTIN
Urocortin II (UCN-2), a recently discovered endogenous peptide ligand of the
CRF-R2 receptor is present in the cardiovascular system, notably the heart and
cerebral arterial system and is expressed in cardiac, brain, and
gastrointestinal tissues. Expression of cardiac UCN-2 is increased in
experimental models of heart failure, and patients with mild to moderate heart
failure have been shown to have increased levels of plasma UCN-2. In
pre-clinical studies, UCN-2 demonstrated potent inotropic, vasodilator,
cardio-protective, and diuretic effects.
- Final preclinical safety study currently underway.
- Phase I trials are expected to begin this year targeting acute
congestive heart failure.
ALTERED PEPTIDE LIGAND (APL) FOR MULTIPLE SCLEROSIS
A Phase II clinical trial with NBI-5788 for the treatment of relapsing MS was
initiated July 2003 to evaluate the safety and tolerability of 5 mg injections
of NBI-5788 administered in 5 weekly doses followed by eight monthly doses for a
period of nine months. A previous Phase II study of NBI-5788 with patients
receiving subcutaneous injections of 5, 20 and 50 mg or placebo suggested
clinical improvement for those patients receiving the lowest dose (5 mg). Based
on the results from this earlier study, this new trial will further identify the
efficacy and safety of NBI-5788 at this 5 mg dose.
- Enrollment is currently ongoing in 25 sites throughout the US
and Canada and is expected to complete toward the end of 2004.
- Results from this second Phase II trial are expected in 2005.
ALTERED PEPTIDE LIGAND FOR TYPE I DIABETES
Neurocrine has successfully completed four Phase I/II clinical trials with
NBI-6024 for Type I Diabetes.
- Completed enrollment in a Phase II, dose response, efficacy
and safety trial in approximately 200 adults/adolescents with
new onset Type 1 diabetes.
- Preliminary results are expected in 2005.
D2 RECEPTOR AGONIST
Neurocrine acquired the rights from Pharmacia for NBI-69733, a selective
dopamine D2 receptor agonist, to develop indications related to male and female
sexual dysfunction.
- A Phase II trial in male erectile dysfunction (MED) is
currently being planned.
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RESEARCH OVERVIEW
Neurocrine's Research Department continues to progress small molecule
antagonists against G-protein coupled receptors (GPCRs) into clinical
development. It is believed one or more will progress into clinical development
within the year. They include the following:
- MC-4 is at the development compound stage and represents a
novel target for the treatment of obesity, cachexia and pain.
- MCH is currently at the advanced lead compound stage and is
believed to play an important role in the treatment of
obesity, anxiety and depression.
- New Insomnia Program is at the advanced lead stage to treat
various sleep disorders.
CONFERENCE CALL AND WEBCAST
Neurocrine will also host a live conference call and Webcast to discuss its
first quarter financial results and provide a Company update today, Monday, May
3, 2004 at 11:00 AM Eastern Time (ET) / 8:00 AM Pacific Time (PT). Participants
may access the live conference call by dialing 1-800-905-0392 (U.S.) or
785-832-0326 (International). The call can also be accessed via the Webcast
through the Company's website at http://www.neurocrine.com or alternatively
through a link provided by PRNewswire at http://www.firstcallevents.com/service
/ajwz405325797gf12.html. A replay of the Conference Call will be available
approximately one hour after the conclusion of the call by dialing
1-888-567-0677 (US) or 402-530-0419 (International) and will be archived until
Monday, May 17, 2004.
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, certain female and male disorders, anxiety, depression,
diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain,
and autoimmunity. 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 and research programs in general including,
but not limited to, risk and uncertainties associated with, or arising out of,
drug discovery, pre-clinical and clinical development of products including risk
that the Company's Urocortin and CRF research programs will not lead to clinical
candidates, that the GnRH receptor antagonist, D2 receptor agonist and altered
peptide ligand clinical candidates will not proceed to later stage clinical
trials and risks and uncertainties associated with the Company's indiplon Phase
III program and planned regulatory activities. Specifically, the risks and
uncertainties the Company faces with respect to its indiplon program include,
but are not limited to,
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risk that indiplon may not successfully proceed through Phase III clinical
trials including the risk that Phase III clinical trials may fail to demonstrate
that indiplon is safe and effective in treating humans and the risk that
additional clinical studies may be required to support filings for regulatory
approval; risk that the Company may not complete indiplon Phase III clinical
trials on the Company's projected timelines for various reasons, including the
risk that the clinical investigators and contract research organizations upon
which the Company relies to conduct its clinical programs may not be diligent,
careful or timely, and may make mistakes, in the conduct of the programs; risk
relating to the Company's dependence on contract manufacturers for clinical drug
supply and compliance with regulatory requirements for marketing approval; risk
that the Company may not successfully co-ordinate the completion and submission
of planned regulatory filings on the Company's projected timelines; risk that
the Company may not receive regulatory approval for indiplon or approval may be
delayed; 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; risk
that the Company will be unable to raise additional funding required to complete
development of all of its product candidates; and the other risks described in
the Company's report on Form 10-K for the year ended December 31, 2003.
Neurocrine undertakes no obligation to update the statements contained in this
press release after the date hereof.
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NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT FOR LOSS PER SHARE DATA)
Three Months Ended
March 31,
--------------------------
2004 2003
(unaudited) (unaudited)
----------- -----------
Revenues:
Sponsored research and development $ 5,369 $ 30,725
License fees 11,319 6,667
Grant income 253 324
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Total revenues 16,941 37,716
Operating expenses:
Research and development 26,388 48,324
General and administrative 5,283 4,744
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Total operating expenses 31,671 53,068
Loss from operations (14,730) (15,352)
Other income and (expenses):
Interest and other income, net 2,353 2,065
Other income, net -- 48
Loss before income tax expense (12,377) (13,239)
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Income tax expense 3 151
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Net loss $(12,380) $(13,390)
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Loss per common share:
Basic and Diluted $ (0.35) $ (0.43)
Shares used in the calculation of loss per common share:
Basic and Diluted 35,527 30,789
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
March 31, December 31,
2004 2003
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(unaudited)
Cash, cash equivalents and marketable securities $371,733 $453,168
Other current assets 9,917 18,641
Total current assets 381,650 471,809
Property and equipment, net 79,044 56,236
Prepaid royalties 95,000 --
Other non-current assets 21,575 26,910
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Total assets $577,269 $554,955
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Current liabilities $ 97,536 $110,012
Long-term liabilities 54,328 53,823
Stockholders' equity 425,405 391,120
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Total liabilities and stockholders' equity $577,269 $554,955
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