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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): August 3, 2005
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 0-22705 | 33-0525145 | ||
| (State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
| 12790 El Camino
Real, San Diego, CA |
92130 | |||
| (Address of principal executive offices) |
(Zip Code) | |||
Registrant’s 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:
o
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
o
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
o
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b)) | |
o
|
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.. | ||||||||
| ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS. | ||||||||
| SIGNATURES | ||||||||
| EXHIBIT 99.1 | ||||||||
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ITEM 2.02 RESULTS OF OPERATION AND FINANCIAL CONDITION.
On August 3, 2005, Neurocrine Biosciences, Inc. announced its financial results for the quarter ended June 30, 2005. 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:
| Exhibit | ||
| Number |
Description of Exhibit |
|
99.1
|
Press Release dated August 3, 2005 |
1
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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.
| Dated: August 3, 2005 | NEUROCRINE BIOSCIENCES, INC. |
|||
| /s/ PAUL W. HAWRAN | ||||
| Paul W. Hawran | ||||
| Executive Vice President and Chief Financial Officer |
||||
2
Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact at Neurocrine Biosciences
Elizabeth Foster or Claudia Jones-Woodworth
(858) 617-7600
Contact at Neurocrine Biosciences
Elizabeth Foster or Claudia Jones-Woodworth
(858) 617-7600
NEUROCRINE BIOSCIENCES REPORTS SECOND QUARTER 2005 RESULTS
San Diego, CA, August 3, 2005 — Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its
financial results for the quarter ended June 30, 2005. For the second quarter, the Company reported
a net loss of $5.6 million, or $0.15 per share compared with a net loss of $11.1 million, or $0.31
per share, for the same period last year. For the six months, the Company reported a net loss of
$24.4 million, or $0.67 per share, as compared to $23.5 million, or $0.65 per share, for the same
period last year.
Revenues for the second quarter of 2005 were $33.2 million compared with $15.0 million for the
respective period last year. Revenues for the six months ended June 30, 2005 were $45.0 million
compared with $32.0 million for the same period in 2004. The increase in revenues for the three and
six month periods is primarily due to achievement of a $20.0 million milestone under the Pfizer
agreement related to the acceptance for review of the New Drug Application (NDA) filing for
indiplon capsules by the U.S. Food and Drug Administration. Additionally, sponsored development
revenue associated with the indiplon clinical program increased compared to last year. During 2005,
the Company recognized $2.7 million and $6.7 million, for the three and six months ended June 30,
2005 in the form of sponsored development funding under the Pfizer collaboration agreement compared
to $1.1 million and $5.1 million for the three and six months ended June 30, 2004. License fees,
milestones and sales force allowance recognized under the Pfizer collaboration were $30.4 million
and $36.9 million for the three and six months ended June 30, 2005 and $11.5 million and $22.5
million for the three and six months ended June 30, 2004.
Research and development expenses increased to $29.6 million for the second quarter of 2005 from
$23.0 million for the respective period in 2004. For the six months ended June 30, 2005, research
and development expenses were $55.2 million compared to $49.4 million for the same period last
year. This increase in expenses primarily reflect increased personnel and laboratory costs, as well
as external development costs related to the GnRH, Urocortin 2 and Multiple Sclerosis programs.
Sales, general and administrative expenses increased to $9.8 million for the second quarter of 2005
compared with $5.5 million during the same period last year. For the six months ended June 30,
2005, sales, general and administrative expenses were $15.4 million compared to $10.8 million
for the respective period in 2004. The increase in expenses from 2004 to 2005
resulted primarily from activities surrounding the implementation of the commercialization
strategy, including hiring and training the 200 person sales force. Sales force costs are largely
reimbursed by Pfizer.
- more-
The Company’s balance sheet on June 30, 2005 reflected total assets of $475.5 million,
including cash, cash equivalents, marketable securities, and receivables due under the
collaboration agreement of $266.1 million as compared with balances at December 31, 2004 of $519.2
million and $309.3 million, respectively.
R & D Pipeline Update
Indiplon for Insomnia
Neurocrine announced recently that the U.S. Food and Drug Administration (FDA) has accepted the
Company’s New Drug Application (NDA)s for indiplon capsules and tablets for review for the
treatment of insomnia in both adult and elderly patients.
Neurocrine’s sales force has commenced the co-detailing of ZoloftÒ with Pfizer in the second
quarter of 2005. The Company’s psychiatric specialty sales force of 200 has been fully recruited,
trained and deployed. All Zoloft® product and sales training was conducted by Pfizer. Neurocrine’s
Sales and Marketing organization is actively preparing for the launch of indiplon.
Neurocrine presented four abstracts at the recent American Psychiatric Association (APA) and the
Associated Professional Sleep Societies (APSS) Annual Meetings. Highlights of the meetings included
data that showed that nightly administration of indiplon resulted in significant and sustained
improvement in sleep onset and sleep maintenance in patients with chronic insomnia over the entire
treatment period. Data also showed there was no evidence of tolerance over three months or
withdrawal upon discontinuation of treatment – complications often seen with extended use of
older-generation sleep medications. The results of several studies presented showed that indiplon
capsules and tablets safely and effectively help elderly patients with chronic insomnia fall asleep
faster and stay asleep throughout the night.
GnRH Antagonists for Women’s Health Disorders
Neurocrine completed three Phase I single and multiple dose clinical studies with a GnRH antagonist
candidate, NBI-56418 in approximately 50 healthy pre-menopausal women and in approximately 20
healthy males. Under single and multiple dosing, NBI-56418 demonstrated suppression of luteinizing
hormone (LH) and estradiol in females, while single doses of NBI-56418 in males resulted in
suppression of LH and testosterone. In all studies, NBI-56418 was shown to be safe and well
tolerated. In preparation of long term studies, including those designed to demonstrate efficacy,
Neurocrine completed enrollment in a six-week Phase I double-blind, multicenter, parallel group
study of 42-day administration of two dose levels of NBI-56418 in an additional 60 healthy
pre-menopausal women. Safety results demonstrated that NBI-56418 was safe and well tolerated.
Preliminary efficacy results were consistent with previously reported studies demonstrating dose
dependent estrogen suppression vs. placebo with once-a-day dosing. Based on these results, final
doses were selected for a 3-month Phase II study with NBI-56418 in endometriosis. This study was
initiated in April of this year. Additionally, a back-up compound will enter Phase I in the third
quarter this year.
- more-
Urocortin 2 for Congestive Heart Failure
Neurocrine is completing a series of Phase I clinical trials with a proprietary urocortin 2
compound to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of urocortin 2 in
healthy volunteers. In the second quarter of 2005, Neurocrine initiated a Phase IIa clinical study
in patients with mild to moderate congestive heart failure. This later study is expected to be
completed in the third quarter of 2005. The Company anticipates data in the third quarter at which
time the Company plans to file an IND to initiate a trial in patients with stable congestive heart
failure.
In preclinical efficacy and safety studies conducted by Neurocrine, urocortin 2 has shown positive
hemodynamic effects, which may benefit patients with congestive heart failure. Urocortin 2 was
discovered in the laboratory of Neurocrine’s co-founder, Dr. Wylie W. Vale, Professor and Head,
Clayton Foundation for Research for Peptide Biology from the Salk Institute. Neurocrine licensed
urocortin 2 from the Clayton Foundation for Research to further expand the Company’s franchise in
CRF research.
Altered Peptide Ligand (APL) for Multiple Sclerosis (MS)
Neurocrine completed enrollment in a Phase II clinical trial with NBI-5788 in over 150 patients for
the treatment of relapsing MS to evaluate the safety and tolerability of NBI-5788. The Phase II
study is being conducted at 28 sites in the US and Canada and was expanded to five Eastern European
countries in 2004. Results are expected in early-2006.
Altered Peptide Ligand (APL) for Type 1 Diabetes
Neurocrine has successfully completed four Phase I/II clinical trials with NBI-6024 for Type 1
Diabetes. Additionally, the Company has completed enrollment in a Phase II, dose-response, efficacy
and safety trial in approximately 200 adults/adolescents with new onset Type 1 Diabetes. Results
for all patients enrolled are expected in mid-2006.
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). Neurocrine and
GSK are conducting Phase I clinical trials with a lead CRF R1 receptor antagonist
compound for anxiety and depression. The Phase I clinical trial includes double-blind, randomized,
placebo controlled, single-dose studies followed by multiple dose studies to evaluate the safety
and pharmacokinetics (PK) of a range of escalating doses of this compound in healthy volunteers.
Following completion of these clinical trials, the two companies will evaluate this lead compound
in extended Phase I and Phase II proof of concept trials. In addition, a back-up compound is also
expected to enter Phase I clinical trials in 2005.
Additional Research Programs
Neurocrine’s Research Department continues to advance novel small molecule compounds into clinical
development. Neurocrine scientists are focusing on developing small molecule antagonists against
G-protein coupled receptors (GPCRs).
- more-
| • | MC-4 agonists are being optimized for the treatment of male erectile dysfunction and obesity and antagonists for the treatment of cachexia. | ||
| • | In addition, new orally active small molecule antagonists are being developed to treat various sleep disorders. | ||
| • | Neurocrine scientists are also developing A2A antagonists for Parkinson’s disease. |
Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine will also host a live conference call and Webcast to discuss its second quarter
financial results and provide a Company update Wednesday afternoon, August 3, 2005 at 4:30 PM
Eastern Daylight Time (EDT) / 1:30 PM Pacific Daylight Time (PDT). Participants may access the live
Conference Call by dialing 1-800-540-0559 (U.S.) or 785-832-1508 (International) and using the
Conference ID# NBIX. The call can also be accessed via the Webcast through the Company’s website
at http://www.neurocrine.com
If you are unable to attend the Webcast and would like further information on this announcement
please contact Claudia Jones-Woodworth or Elizabeth Foster in 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 1-888-562-2815 (US) or
402-220-7352 (International) and will be archived until Wednesday, August 17, 2005.
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, 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 the Company’s indiplon
program and research and development activities. Specifically, the risks and uncertainties the
Company faces with respect to its indiplon program include, but are not limited to risk that
regulatory authorities may find either or both of our indiplon NDAs incomplete or insufficient or
for any other reason not approvable; risk that the indiplon labeling granted by regulatory
authorities may limit the commercial success of indiplon; and risk relating to market acceptance of
indiplon following marketing approval. Specifically, the risks and uncertainties the Company faces
with respect to the Company’s drug discovery, pre-clinical and clinical development of products
including risk that the Company’s CRF back-up, A2A antagonists and MC-4 research programs will not
lead to viable clinical candidates, risk
- more-
that the GnRH receptor antagonist, urocortin 2, CRF and altered peptide ligand clinical
candidates will not proceed to later stage clinical trials; risk relating to the Company’s
dependence on contract manufacturers for clinical drug supply and compliance with regulatory
requirements for marketing approval; risks associated with the Company’s dependence on third
parties for commercial manufacturing 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, 2004 and most recent report on Form 10-Q filed for the quarter ended, June 30,
2005. 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)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2005 | 2004 | 2005 | 2004 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
Revenues: |
||||||||||||||||
Sponsored research and development |
$ | 2,721 | $ | 2,506 | $ | 7,137 | $ | 7,875 | ||||||||
License fees and milestones |
25,448 | 12,388 | 31,896 | 23,707 | ||||||||||||
Sales force allowance |
5,000 | — | 6,000 | — | ||||||||||||
Grant income |
— | 155 | — | 408 | ||||||||||||
Total revenues |
33,169 | 15,049 | 45,033 | 31,990 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
29,633 | 22,969 | 55,236 | 49,357 | ||||||||||||
Sales, general and administrative |
9,788 | 5,469 | 15,396 | 10,752 | ||||||||||||
Total operating expenses |
39,421 | 28,438 | 70,632 | 60,109 | ||||||||||||
Loss from operations |
(6,252 | ) | (13,389 | ) | (25,599 | ) | (28,119 | ) | ||||||||
Other income and (expenses): |
||||||||||||||||
Interest income and expense, net |
659 | 2,259 | 1,176 | 4,612 | ||||||||||||
Other income and (expense), net |
(11 | ) | (1 | ) | (11 | ) | (4 | ) | ||||||||
Total other income |
648 | 2,258 | 1,165 | 4,608 | ||||||||||||
Net loss |
$ | (5,604 | ) | $ | (11,131 | ) | $ | (24,434 | ) | $ | (23,511 | ) | ||||
Net loss per common share: |
||||||||||||||||
Basic and diluted |
$ | (0.15 | ) | $ | (0.31 | ) | $ | (0.67 | ) | $ | (0.65 | ) | ||||
Shares used in the calculation of net loss per common share: |
||||||||||||||||
Basic and diluted |
36,647 | 36,368 | 36,623 | 35,947 | ||||||||||||
NEUROCRINE BIOSCIENCES, INC.
Condensed Consolidated Balance Sheets
(in thousands)
| June 30, | December 31, | |||||||
| 2005 | 2004 | |||||||
| (unaudited) | ||||||||
Cash, cash equivalents and marketable securities |
$ | 243,268 | $ | 301,129 | ||||
Other current assets |
28,257 | 12,686 | ||||||
Total current assets |
271,525 | 313,815 | ||||||
Property and equipment, net |
99,811 | 102,166 | ||||||
Prepaid royalty |
94,000 | 94,000 | ||||||
Other non-current assets |
10,176 | 9,236 | ||||||
Total assets |
$ | 475,512 | $ | 519,217 | ||||
Current liabilities |
$ | 40,294 | $ | 59,585 | ||||
Long-term liabilities |
63,199 | 65,805 | ||||||
Stockholders’ equity |
372,019 | 393,827 | ||||||
Total liabilities and stockholders’ equity |
$ | 475,512 | $ | 519,217 | ||||