AVANIR Pharmaceuticals (AMEX:AVN.R) today reported financial
results for the first quarter of fiscal 2006, ended December 31,
2005. AVANIR reported a net loss for the first quarter of fiscal
2006 of $5.7 million, or $0.20 per share, compared to $7.1 million,
or $0.30 per share, for the same period a year ago. In the first
quarter of fiscal 2006, AVANIR continued the clinical development
of Neurodex(TM) for the treatment of Involuntary Emotional
Expression Disorder, or IEED, (also known as Pseudobulbar Affect or
Emotional Lability) and Diabetic Neuropathic Pain. Subsequent to
the end of the quarter, AVANIR completed the submission of its new
drug application (NDA) to the U.S. Food and Drug Administration
(FDA) for Neurodex(TM), seeking marketing approval of the drug
candidate for the treatment of IEED. Additionally, during the
quarter the Company continued its fully sponsored R&D
partnerships with AstraZeneca and Novartis International Ltd. for
programs in reverse cholesterol transport and inflammation,
respectively. The Company's operating expenditures in the quarter
were partially offset by revenues earned from milestones achieved
and research support provided under these two license agreements,
and government research grants. The first quarter of fiscal 2006
was highlighted by the following activities: -- Appointment of two
new members to the Company's Board of Directors; Craig A. Wheeler
and Scott M. Whitcup, M.D.; -- Completion of two stock offerings
raising a total of $35.5 million; and -- Earned a $5.0 million
milestone from AstraZeneca that was received subsequent to the
close of the quarter related to filing an investigational new drug
application that allowed the initiation of Phase I safety studies.
Subsequent to the close of the quarter, AVANIR: -- Implemented a
1-for-4 reverse stock split; -- Licensed docosanol 10% cream in
Japan; -- Completed the submission of reformatted and supplemental
safety data for the Company's new drug application for Neurodex in
the treatment of IEED; and -- Received approximately $4.7 million
from the exercise of the Company's outstanding Class A Warrants
that were called by the Company. Revenues of $8.1 million for the
first quarter of fiscal 2006 included $5.0 million relating to the
achievement of a milestone from AstraZeneca, $2.5 million in
R&D research services, $582,000 in revenues that the Company
recognized from the sale of abreva(R) royalty rights, and $85,000
from government research grants. Revenues in the first quarter of
fiscal 2005 amounted to $888,000 and included $510,000 in revenues
that the Company recognized from the sale of abreva royalty rights,
$200,000 relating to the achievement of milestones under license
agreements, and $161,000 from government research grants. Total
operating expenses for the first quarter of fiscal 2006 were $14.1
million, compared to $8.0 million in the same period a year ago.
Expenditures on research and development (R&D) programs
accounted for 66% and 63% of total operating expenses for the
quarters ended December 31, 2005 and 2004, respectively. R&D
expenses for the first quarter of fiscal 2006 amounted to $9.4
million, compared to $5.1 million for the same period a year ago,
with the increase primarily attributable to the Company's ongoing
Phase III clinical trial for Neurodex for neuropathic pain.
Selling, general and administrative expenses increased
year-over-year, rising to $4.8 million in the first quarter of
fiscal 2006, from $3.0 million in the first quarter of fiscal 2005,
with the increase primarily attributable to an increase in
pre-launch marketing activities for Neurodex. Balance Sheet
Highlights As of December 31, 2005, AVANIR had cash, cash
equivalents, and investments in securities totaling $51.3 million
(excluding the earned $5 million milestone from AstraZeneca which
was received after the quarter end), compared to $27.5 million as
of September 30, 2005. Net working capital balance was $44.4
million, deferred revenue was $18.6 million and shareholders'
equity was $40.9 million as of December 31, 2005. AVANIR completed
stock offerings in December 2005 and October 2005 that resulted in
$19.4 million and $16.1 million in net proceeds, respectively.
Conference Call and Webcast Management will host a conference call
with a simultaneous webcast on February 9, 2006 at 1:30 p.m.
Pacific/4:30 p.m. Eastern to discuss first quarter of fiscal 2006
operating performance. The call/webcast will feature President and
Chief Executive Officer Eric Brandt, and Vice President and Chief
Financial Officer Gregory P. Hanson, CMA. The webcast will be
available live via the Internet by accessing AVANIR's web site at
www.avanir.com. Please go to the web site at least ten minutes
early to register, download and install any necessary audio
software. Replays of the webcast will be available for 90 days, and
a phone replay will be available through February 13, 2005 by
dialing 800-642-1687 and entering the passcode 4490357. About
AVANIR AVANIR Pharmaceuticals is focused on developing and
commercializing novel therapeutic products for the treatment of
chronic diseases. AVANIR's product candidates address therapeutic
markets that include central nervous system and cardiovascular
disorders, inflammation, and infectious diseases. AVANIR previously
announced positive results in the second of two required Phase III
clinical trials of Neurodex(TM), an investigational new drug for
the treatment of involuntary emotional expression disorder.
Additionally, AVANIR has initiated a Phase III clinical trial for
Neurodex as a potential treatment in patients with diabetic
neuropathic pain, a second indication for Neurodex. AVANIR has
active collaborations with two international pharmaceutical
companies: Novartis International Pharmaceutical Ltd. for the
treatment of inflammatory disease and AstraZeneca for the treatment
of cardiovascular disease. The Company's first commercialized
product, abreva(R), is marketed in North America by GlaxoSmithKline
Consumer Healthcare and is the leading over-the-counter product for
the treatment of cold sores. Further information about AVANIR can
be found at www.avanir.com. Forward Looking Statements The
information contained in this press release, including any
forward-looking statements contained herein, should be reviewed in
conjunction with the company's most recent Annual Report on Form
10-K and quarterly report on Form 10-Q and other publicly available
information regarding the Company. Copies of such information are
available from the company upon request. Such publicly available
information sets forth many risks and uncertainties related to the
company's business and technology. Forward-looking statements often
contain such words like "estimate," "anticipate," "believe," "plan"
or "expect." AVANIR disclaims any intent or obligation to update
these forward-looking statements. -0- *T AVANIR PHARMACEUTICALS
Summary Consolidated Financial Information (Unaudited) Three Months
Ended December 31, ------------------------- Consolidated Statement
of Operations Data: 2005 2004
------------------------------------------ ------------
------------ Revenues $8,144,888 $888,365 ------------ ------------
Operating expenses Research and development 9,363,402 5,054,241
Selling, general and administrative 4,768,743 2,951,003 Cost of
product sales - 3,102 ------------ ------------ Total operating
expenses 14,132,145 8,008,346 ------------ ------------ Loss from
operations (5,987,257) (7,119,981) Interest income 328,166 121,832
Interest expense (23,438) (21,621) Other income (expense), net
10,512 (66,921) ------------ ------------ Loss before income taxes
(5,672,017) (7,086,691) Provision for income taxes (2,417) (1,898)
------------ ------------ Net loss $(5,674,434) $(7,088,589)
============ ============ Net loss per share: Basic and diluted(1)
$(0.20) $(0.30) ============ ============ Weighted average number
of common shares outstanding: Basic and diluted(1) 28,579,357
23,962,989 ============ ============ Consolidated Balance Sheet
Data: December 31, September 30, 2005 2005
-------------------------------- ------------ ------------ Cash and
cash equivalents $30,801,894 $8,620,143 Short-term, long-term and
restricted investments in securities 20,540,230 18,917,443
------------ ------------ Total cash and investments $51,342,124
$27,537,586 ============ ============ Net working capital
$44,356,945 $11,969,450 Total assets $71,743,265 $41,401,990
Deferred revenue $18,604,613 $19,158,210 Total liabilities
$30,864,103 $32,267,111 Shareholders' equity $40,879,162 $9,134,879
(1) The shares outstanding and earnings per shares have been
adjusted for the one-for-four split. *T
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