Neurobiological Technologies Reports Fourth Quarter and Fiscal 2004
Financial Results RICHMOND, Calif., Aug. 19 /PRNewswire-FirstCall/
-- Neurobiological Technologies, Inc. (NTI(R)) (NASDAQ:NTII) today
announced its results for the fourth quarter and fiscal year ended
June 30, 2004. Net loss for the fiscal fourth quarter ended June
30, 2004 was $1,015,000, or $0.04 per share, compared to net loss
of $670,000, or $0.04 per share, for the same period last year. For
the 2004 fiscal year, the company reported a net loss of
$1,808,000, or $0.09 per share, compared to net loss of $2,686,000,
or $0.15 per share, in fiscal 2003. Fiscal 2004 fourth quarter
revenue was $175,000, a 40 percent decrease reflecting no license
income received and $175,000 of royalty income, compared to
$281,000 of license income and $11,000 of royalty income for the
same period in the prior fiscal year. For the full fiscal 2004
year, revenue increased 41 percent to $2,787,000, compared to
$1,980,000 in fiscal 2003. The increase was due to $2,531,000 from
license income and $256,000 from royalty income in fiscal 2004,
compared to $1,969,000 of license income and $11,000 of royalty
income in the prior year. Research and development expenses were
$532,000 for the fiscal fourth quarter, an increase of 79 percent
compared to $297,000 for the same period in the prior year. The
increase was primarily due to costs associated with the initiation
of a Phase III clinical trial of XERECEPT(TM). For the 2004 fiscal
year, research and development expenses decreased 9 percent to
$2,098,000 compared to $2,317,000 for fiscal 2003. The decrease was
primarily due to the completion of manufacturing an additional
supply of XERECEPT. General and administrative expenses increased
13 percent to $781,000 for the fourth quarter compared to $693,000
for the same period in the prior year reflecting higher
expenditures for professional services. For the 2004 fiscal year,
general and administrative expenses increased 24 percent to
$3,102,000, compared to $2,493,000 in the prior year. The increase
was primarily due to increased expenditures in professional
services and employee benefits. Interest income increased to
$76,000 in the fiscal fourth quarter compared to $28,000 in the
same period last year due to a higher cash balance as a result of
money received in our March 2004 private placement financing and a
license fee payment received for the approval of Memantine
(Namenda(TM)) in the United States. Interest income decreased 11
percent to $128,000 for the 2004 fiscal year compared to $144,000
in the prior year primarily due to lower average cash balances. At
June 30, 2004, the company's cash and cash equivalents and
investments were $20,734,000, with no long-term debt. Subsequent to
the end of the fiscal year, the company acquired Empire
Pharmaceuticals, Inc., a privately held company, in a stock and
cash transaction valued at up to approximately $22.8 million. As
part of the transaction, NTI has acquired the exclusive worldwide
rights to Viprinex(TM) (ancrod), a late-stage perfusion therapy for
use in the treatment of acute ischemic stroke. Under the terms of
the agreement, NTI initially issued 2,339,168 shares of common
stock and paid $2 million in cash to Empire stockholders. If
pivotal Phase III trials for Viprinex are commenced as currently
planned, NTI will issue an additional 2,375,176 shares and pay an
additional $2 million to the Empire stockholders. "We are in the
strongest position in our company's history, with three products
either commercialized or in late stage clinical development,"
stated Paul Freiman, President and Chief Executive Officer of NTI.
"Memantine, for Alzheimer's disease, continues to capture market
share and perform brilliantly. In fact, subsequent to the year-end
closing, we received $404,000 from Merz, representing our share of
royalties. We anticipate this number will continue to grow as sales
of Memantine are expected to continue to ramp up. Forest
Laboratories, Inc. continues to develop Memantine for neuropathic
pain. XERECEPT, a treatment for the swelling around brain tumors,
entered Phase III clinical trials in May 2004 and we are actively
engaged in overseeing these trials. Additionally, we are currently
designing clinical trial protocols for what we expect to be pivotal
Phase III clinical trials for our newest product, Viprinex
(ancrod), for the treatment of ischemic stroke. We expect to seek
FDA approval for these trials and have hired key personnel who are
familiar with Viprinex to accelerate our efforts. For the first
time I can say we are making progress in building a more
substantial pipeline. Equally important is the fact that we have a
strong cash position which, combined with the anticipated growing
royalties from sales of Memantine, should enable us to fund the
development of this pipeline. This is indeed a good time for NTII."
Conference Call Information NTI will web cast its fourth quarter
and fiscal year end 2004 results conference call today, August 19,
2004 at 10:30 a.m. ET, 7:30 a.m. PT. Dial- in number (888)
208-1812. The live web cast can be accessed by going to
http://www.shareholder.com/ntii/medialist.cfm . A playback will be
available by telephone beginning today at 1:30 p.m. ET, 10:30 a.m.
PT, until August 26, 2004 at midnight ET, 9:00 p.m. PT. Replay
number: (888) 203-1112 (U.S. and Canada) & (719) 457-0820
(Int'l), access code: 964972. About Neurobiological Technologies,
Inc. NTI is an emerging drug development company focused on the
clinical evaluation and regulatory approval of neuroscience drugs.
The company's strategy is to in-license and develop early- and
later-stage drug candidates that target major medical needs and
which can be rapidly commercialized. NTI's experienced management
team oversees the human clinical trials necessary to establish
preliminary evidence of efficacy and seeks partnerships with
pharmaceutical and biotechnology companies to complete development
and marketing of its product candidates. NOTE: Except for the
historical information contained herein, the matters discussed in
this press release are forward-looking statements that involve
risks and uncertainties, including: our dependence on Merz and its
marketing partners for the successful commercialization of
Memantine, our ability to develop and meet regulatory requirements
for our products, including XERECEPT and Viprinex, the inherent
risk of failure in developing product candidates based on new
technologies, the risks of acquiring companies and new technologies
and other risks detailed from time to time in our Securities and
Exchange Commission filings. Actual results may differ materially
from those projected. These forward-looking statements represent
our judgment as of the date of the release. We disclaim, however,
any intent or obligation to update these forward-looking
statements. CONDENSED STATEMENTS OF OPERATIONS (Unaudited) Three
months ended Year ended June 30, June 30, 2004 2003 2004 2003
REVENUES License income $-- $281,000 $2,531,000 $1,969,000 Royalty
income 175,000 11,000 256,000 11,000 Total revenues 175,000 292,000
2,787,000 1,980,000 EXPENSES Research and development 532,000
297,000 2,098,000 2,317,000 General and administrative 781,000
693,000 3,102,000 2,493,000 Total expenses 1,313,000 990,000
5,200,000 4,810,000 Operating loss (1,138,000) (698,000)
(2,413,000) (2,830,000) Interest income 76,000 28,000 128,000
144,000 Derivative income 47,000 -- 477,000 -- NET LOSS
$(1,015,000) $(670,000) $(1,808,000) $(2,686,000) BASIC and DILUTED
NET LOSS PER SHARE $(0.04) $(0.04) $(0.09) $(0.15) Shares used in
basic and diluted net loss per share calculation 23,918,104
18,523,542 20,678,914 18,015,644 SELECTED BALANCE SHEET DATA
(Unaudited) June 30, June 30, 2004 2003 Cash and cash equivalents
and investments $20,734,000 $4,402,000 Working capital 13,582,000
4,238,000 Total assets 21,384,000 4,813,000 Deficit accumulated
during development stage (42,325,000) (40,517,000) Stockholders'
equity 20,723,000 4,248,000 DATASOURCE: Neurobiological
Technologies, Inc. CONTACT: Paul E. Freiman, President & CEO of
Neurobiological Technologies, Inc., +1-510-262-1730; or Roger
Pondel, or Rob Whetstone, both of PondelWilkinson Inc.,
+1-310-279-5980, for Neurobiological Technologies, Inc. Web site:
http://www.ntii.com/ http://www.shareholder.com/ntii/medialist.cfm
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