Neurocrine Biosciences, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of the earliest event reported): February 1, 2007
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other
jurisdiction of
incorporation or
organization)
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0-22705
(Commission File
Number)
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33-0525145
(IRS Employer Identification
No.) |
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12790 El Camino Real
(Address of principal executive offices)
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92130
(Zip Code) |
Registrants telephone number, including area code: (858) 617-7600
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2 (b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4 (c)) |
TABLE OF CONTENTS
ITEM 2.02 RESULTS OF OPERATION AND FINANCIAL CONDITION.
On February 1, 2007, Neurocrine Biosciences, Inc. announced its financial results for the year
ended December 31, 2006. The full text of the press release issued in connection with the
announcement is filed as Exhibit 99.1 to this Current Report on Form 8-K.
In accordance with General Instruction B.2. of Form 8-K, the information in this Current Report of
Form 8-K, including Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, (Exchange Act) or otherwise subject to the liability
of that section, nor shall it be deemed incorporated by reference in any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific
reference in such a filing.
Item 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
(c) EXHIBITS. The following exhibit is filed herewith:
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Exhibit |
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Number |
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Description of Exhibit |
99.1
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Press Release dated February 1, 2007 |
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Dated: February 1, 2007 |
NEUROCRINE BIOSCIENCES, INC.
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/s/ TIMOTHY P. COUGHLIN
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Timothy P. Coughlin |
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Vice President and Chief Financial Officer |
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EXHIBIT INDEX
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Exhibit |
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Number |
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Document Description |
99.1
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Press Release dated February 1, 2007 |
exv99w1
Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact at Neurocrine Biosciences
Elizabeth Foster
(858) 617-7600
NEUROCRINE BIOSCIENCES REPORTS FOURTH QUARTER AND YEAR-END 2006 RESULTS
San Diego, CA, February 1, 2007 Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its
financial results for the fourth quarter and year ended December 31, 2006. For the three months
ended December 31, 2006, the Company reported a net loss of $14.7 million or $0.39 loss per share
compared to a net loss of $23.9 million or $0.65 loss per share for the same period last year. For
the year ended December 31, 2006, the Company had a net loss of $107.2 million, or $2.84 loss per
share compared with a net loss of $22.2 million, or $0.60 loss per share in 2005.
Revenues for the fourth quarter of 2006 were $9.4 million compared with $14.1 million for the same
period last year. The decrease in revenues for the three months ended December 31, 2006 resulted
primarily from license fee revenues arising from the Pfizer collaboration of $0.7 million and $4.4
million during the fourth quarter of 2006 and 2005, respectively. The sales force allowance earned
under the collaboration agreement was $8.0 million for the fourth quarter of 2005. Additionally,
the Company recognized milestones related to CRF drug candidate development earned under the
GlaxoSmithKline (GSK) agreement of $8.0 million for the fourth quarter of 2006 compared to $1.0
million in fourth quarter of 2005.
Revenues for the year ended December 31, 2006, were $39.2 million, compared with $123.9 million for
2005. The decrease in revenues for the year ended December 31, 2006 resulted primarily from the
achievement of $70.0 million in milestones from Pfizer during 2005. The Company recognized $6.6
million and $8.7 million in the form of sponsored development funding under the Pfizer
collaboration agreement for the years ended December 31, 2006 and 2005, respectively. License fees
recognized under the Pfizer collaboration were $6.5 million and $20.7 million for the years ended
December 31, 2006 and 2005, respectively. The sales force allowance earned under the collaboration
agreement was $16.5 million for 2006 and $22.0 million in 2005. The Company also recognized
milestones under the GSK collaboration agreement of $9.0 and $2.0 million during the years ended
December 31, 2006 and 2005, respectively.
Research and development expenses decreased by $6.2 million to $18.6 million for the fourth quarter
of 2006 compared with $24.8 million for the same period in 2005, primarily resulting from decreased
workforce, laboratory and external development costs. For the year ended December 31, 2006,
research and development expenses were $97.7 million compared to $106.6 million last year. This
$8.9 million decrease in year-to-date research and development expenses are primarily a result of
the wind down of the Phase III indiplon clinical program.
Sales, general and administrative expenses were $7.1 million for the fourth quarter 2006 compared
with $13.9 million for the same period in 2005, a direct result of our severance program during the
third quarter of 2006. For the year ended December 31, 2006 sales, general and administrative
expenditures totaled $54.9 million compared to $42.3 million in 2005. The increase in expenses
from 2005 to 2006 resulted primarily from sales force costs.
The Companys balance sheet at December 31, 2006 reflected total assets of $389.7 million including
cash, cash equivalents, and marketable securities of $182.6 million, compared with balances at
December 31, 2005 of $483.1 million and $273.1 million, respectively.
Financial Guidance for 2007
The Company expects the net cash burn for 2007 to be approximately $80.0 million. The savings
realized from the recent cancellation of the indiplon capsules trial will be utilized in
pre-commercialization activities as well as Phase IIIb/IV trials during 2007. The Company expects
to end 2007 with over $160 million in cash, cash equivalents, marketable securities and receivable
equity in its property.
As we begin 2007, we now plan to resubmit our New Drug Application (NDA) for indiplon capsules at
the end of the 2nd Quarter of 2007. We reached this decision after reviewing data with
independent statistical, regulatory and clinical consultants along with interactions with the FDA,
and believe that indiplon will provide flexibility to treat insomnia as needed to help patients
fall asleep quickly or return to sleep after a nighttime awakening. In parallel, our corporate
objectives will be focused toward advancing the pipeline led by our GnRH and CRF programs.
Neurocrines R & D group continues to develop new therapeutic approaches as evidenced by our newest
drug candidate, sNRI for neuropathic pain, which entered Phase I clinical trials in January of
2007, said Gary A. Lyons, President and CEO of Neurocrine Biosciences.
Indiplon
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Announced plans to resubmit NDA for indiplon capsules (5 mg and 10 mg) at the end of
the 2nd quarter 2007. |
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Substantially completed FDA requests for reanalysis of previously submitted indiplon
capsules data. |
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Plan to initiate market development and Phase IIIb/IV clinical trials in the second
half of 2007. |
R &D Pipeline Update
Neurocrines clinical development group and corporate partners are advancing six drug candidates
through clinical development and will report on R & D progress throughout 2007. Neurocrine
scientists continue to build up Neurocrines pipeline and meet the Company-wide goal of bringing
one new compound into development each year.
GnRH Antagonists for endometriosis:
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Recently announced positive results from second Phase II 3-month dose-response
clinical trial in endometriosis. |
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Initiated a 6-month Phase IIb clinical trial with NBI-56418 for the treatment of
endometriosis during the 4th Quarter 2006. |
CRF1 Antagonists for IBS and Anxiety/Depression:
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GSK initiated Phase II proof of concept clinical trials in two indications, IBS
and social anxiety disorder (SocAD) in late 2006. |
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An additional lead compound is currently in Phase I multi-dose trials. |
Urocortin 2 for CHF:
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Results from a Phase II dose response trial involving patients with stable
congestive heart failure (CHF) demonstrated prominent hemodynamic activity with
increased cardiac output during the 4-hour infusions. The infusions were generally safe
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well tolerated and without untoward effects on renal, cardiac or hormonal assessments. |
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Initiation of a Phase II trial with greater than 24-hour infusions of urocortin 2
are awaiting additional preclinical data to support the longer duration infusions. |
Selective Norepinephrine Reuptake Inhibitor (sNRI) for Neuropathic Pain
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Neurocrine initiated Phase I clinical trials with its new clinical candidate for
neuropathic pain in early 1st Quarter 2007. |
GnRH Antagonists Report Positive Results and Expanded Phase II Development in Endometriosis
Neurocrine announced positive preliminary results from its second proof of concept safety and
efficacy Phase II clinical trial over a 3-month treatment period using its proprietary,
orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist (NBI-56418). The
study was a multi-center, randomized, double-blind, placebo-controlled trial involving patients
with a confirmed diagnosis of endometriosis evaluated in a parallel-group design in which 68
subjects were randomized to one of three treatment groups: placebo, 50 mg of NBI-56418, or 100 mg
of NBI-56418 each administered twice daily. NBI-56418 demonstrated dose-related reductions of
estradiol without evidence of increased risk of bone loss. The reductions in pain scores were
reported within days of treatment initiation for some women and patients with initial improvement
continued to benefit throughout the treatment period. The extent of estradiol suppression and lack
of undesirable metabolic consequences suggest that even higher doses may be acceptable with the
potential for greater symptom reduction. These results were consistent with positive results from
the completion of the first 3-month proof of concept double-blind treatment period and additional
3-month follow up period of a parallel Phase II exploratory trial with NBI-56418 given once daily
to endometriosis patients.
Neurocrine initiated a Phase IIb study in the 4th quarter of 2006 in which 240 patients
with endometriosis will be treated over a 6-month treatment period. This multi-center, randomized,
double-blind, study includes three treatment groups, with two doses of NBI-56418, 150 mg once a day
and 75 mg twice daily, and an active comparator. In addition to confirming the effect of NBI-56418
on endometriosis symptoms, this study is designed primarily to assess the impact of longer
treatment on bone mineral density as measured by DEXA scan at the conclusion of dosing and at
6-months and 12-months post-treatment. The 6-month results, together with data from the previous
two Phase II studies will be the basis for securing agreement to a registration plan acceptable to
the FDA.
CRF1 Antagonists for Anxiety/Depression and IBS in Proof of Concept Phase II Trials
The CRF collaboration between Neurocrine and GlaxoSmithKline (GSK) has identified multiple unique
high affinity and selective antagonists for the CRF receptor that are currently in clinical
development for anxiety-related disorders and irritable bowel syndrome (IBS). GSK recently
initiated Phase II proof of concept clinical trials with a lead Corticotropin Releasing Factor R1
(CRF1) receptor antagonist compound for two indications, social anxiety disorder (SocAD) and IBS.
The first proof of concept trial is a Phase II double-blind, randomized, placebo controlled,
multiple dose study to evaluate the safety and efficacy of the CRF1 antagonist compound
in patients with SocAD. The four-arm study will include more than 200 adult subjects with
Generalized Social Anxiety Disorder/Social Phobia. Efficacy, safety, tolerability and
pharmacokinetics will be assessed. The clinical endpoints of the study include validated scales
for assessment of anxiety disorders including the Liebowitz Social Anxiety Scale and the Social
Avoidance and Distress Scale.
The second proof of concept trial is a Phase II double-blind, randomized, placebo controlled
study to evaluate the safety and efficacy of this compound in patients with IBS. Approximately 100
patients meeting established diagnostic criteria for IBS will be entered into this cross-over
design trial. Standard assessments of safety, tolerability and pharmacokinetics will be conducted.
The clinical endpoints reflect change in symptom frequency and severity via validated scales for
IBS.
GSK has also advanced an additional lead CRF1 receptor antagonist into a Phase I single dose study
in the 1st Quarter of 2006 and this compound is now in a Phase I multi-dose study.
Urocortin 2 for CHF Continues Preclinical Evaluation
Initial results of a Phase II study in patients with stable Congestive Heart Failure (CHF) indicate
that urocortin 2 is generally well tolerated and that the predicted hemodynamic effects on systolic
and diastolic blood pressure, heart rate, cardiac work and, most importantly, cardiac output occur
over the entire 4-hour infusion. The study, a US Phase II study in stable CHF patients, was
designed to assess various hemodynamic endpoints, safety and PK/PD over the 4-hour infusion
treatment period. Cardiac output increased in the range of 6-54% among individual patients with a
minimal increase in heart rate (5-10%). No abnormalities of renal function, electrocardiograms or
biomarkers of cardiac injury (e.g. troponin-T) were observed.
Based on this data, it had been our intent to initiate additional Phase II studies in late 2006
with longer duration infusions of up to 72 hours. However, additional preclinical investigations
are necessary to support longer exposures prior to proceeding. We believe that this data will be
available in mid-2007.
sNRI for Neuropathic Pain Begins Clinical Development
Neurocrine has selected a new compound, a selective norepinephrine reuptake inhibitor (sNRI) for
development for treatment of neuropathic pain and psychiatric disorders. Based on its selective
pharmacologic effect as a norepinephrine reuptake inhibitor, this drug also has potential clinical
utility in a variety of other therapeutic areas including psychiatry, gastroenterology and urology.
Phase I clinical trials were initiated early in the 1st Quarter of 2007.
Additional Research Programs
Neurocrines Research Group continues to advance novel small molecule compounds into clinical
development. Neurocrine scientists are focusing on developing small molecule antagonists against
G-protein coupled receptors.
Neurocrine is currently reviewing in preclinical studies a number of adenosine A2A receptor
antagonists for the treatment of Parkinsons disease. The Company was awarded a grant from The
Michael J. Fox Foundation (MJFF) to evaluate the neuroprotective effects of A2A antagonists in
preclinical models of Parkinsons disease, specifically to assess their potential to modify early
disease progression. This may also help to guide the preclinical selection of drug candidates in
which both symptom relief and neuroprotective actions have been optimized.
Conference Call and Webcast Today at 5:00 PM Eastern Standard Time
Neurocrine will hold a live conference call and webcast today at 5:00 p.m. Eastern Standard Time
(2:00 p.m. Pacific Standard Time). Participants can access the live conference call by dialing
1-800-896-8445 (US) or 785-830-1916 (International) using the conference ID# 7NBIX.
The call can also be accessed via the webcast through the Companys 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 1-800-839-3413 (US) or 402-220-7236 (International). 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 insomnia, anxiety, depression, irritable bowel syndrome, endometriosis and
CNS related disorders. Neurocrine Biosciences, Inc. news releases are available through the
Companys 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 Neurocrines business and finances in general, as well as risks and
uncertainties associated with the Companys indiplon program and R & D pipeline. Specifically, the
risks and uncertainties associated with the Companys indiplon program and planned
commercialization activities, including but not limited to; risk that we will be unable to resubmit
the indiplon capsule NDA in a timely manner or at all; risk that regulatory authorities may refuse
to file our resubmission of the indiplon capsule NDA; risk that regulatory authorities may find
our resubmission of the indiplon capsule NDA incomplete or insufficient or otherwise unapprovable
or that approval may be delayed; risk that following approval of indiplon capsules,
commercialization may be delayed for any of a number of reasons including market conditions and
product supply; risk that we will not be able to independently commercialize indiplon capsules or
find a marketing partner on reasonable terms or at all; risk that the indiplon capsule labeling
granted by regulatory authorities may limit the commercial success of indiplon capsules; and risk
relating to market acceptance of indiplon capsules following marketing approval. In addition, the
Company faces risks and uncertainties with respect to the Companys R & D pipeline including risk
that the Companys GnRH receptor antagonist, urocortin 2, CRF antagonist, and sNRI clinical
candidates will not proceed to later stage clinical trials and that the Companys A2A receptor
antagonist preclinical candidates will not advance to clinical trials; risk relating to the
Companys dependence on contract manufacturers for clinical drug supply; risks associated with the
Companys 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 Companys 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 Companys report on Form 10-K for the year ended December 31, 2005 and the
Companys report on Form 10-Q for the quarter ended September 30, 2006. 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 loss per share data)
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2006 |
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2005 |
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2006 |
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2005 |
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(unaudited) |
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(unaudited) |
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Revenues: |
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Sponsored research and development |
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$ |
213 |
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$ |
753 |
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$ |
6,716 |
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$ |
9,187 |
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License fees and milestones |
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9,227 |
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5,358 |
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16,038 |
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92,702 |
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Sales force allowance |
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8,000 |
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16,480 |
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22,000 |
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Total revenues |
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9,440 |
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14,111 |
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39,234 |
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123,889 |
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Operating expenses: |
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Research and development |
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18,608 |
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24,765 |
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97,678 |
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106,628 |
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Sales, general and administrative |
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7,095 |
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13,940 |
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54,873 |
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42,333 |
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Total operating expenses |
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25,703 |
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38,705 |
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152,551 |
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148,961 |
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Loss from operations |
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(16,263 |
) |
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(24,594 |
) |
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(113,317 |
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(25,072 |
) |
Other income and (expenses): |
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Interest income, net |
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1,543 |
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626 |
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6,576 |
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2,858 |
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Other income (expense), net |
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8 |
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60 |
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(464 |
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23 |
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Total other income |
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1,551 |
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686 |
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6,112 |
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2,881 |
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Net loss |
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$ |
(14,712 |
) |
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$ |
(23,908 |
) |
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$ |
(107,205 |
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$ |
(22,191 |
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Net loss per common share: |
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Basic and diluted |
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$ |
(0.39 |
) |
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$ |
(0.65 |
) |
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$ |
(2.84 |
) |
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$ |
(0.60 |
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Shares used in the calculation of net loss per common share: |
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Basic and diluted |
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37,894 |
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36,992 |
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37,722 |
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36,763 |
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NEUROCRINE BIOSCIENCES, INC.
Condensed Consolidated Balance Sheets
(in thousands)
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December 31, |
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December 31, |
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2006 |
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2005 |
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(unaudited) |
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Cash, cash equivalents and marketable securities |
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$ |
182,604 |
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$ |
273,068 |
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Other current assets |
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11,054 |
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6,242 |
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Total current assets |
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193,658 |
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279,310 |
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Property and equipment, net |
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91,378 |
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99,307 |
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Prepaid royalty |
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94,000 |
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94,000 |
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Other non-current assets |
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10,641 |
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10,506 |
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Total assets |
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$ |
389,677 |
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$ |
483,123 |
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Current liabilities |
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$ |
20,116 |
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$ |
33,693 |
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Long-term liabilities |
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54,845 |
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59,326 |
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Stockholders equity |
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314,716 |
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390,104 |
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Total liabilities and stockholders equity |
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$ |
389,677 |
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$ |
483,123 |
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