Avanir (AMEX:AVN)
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AVANIR Pharmaceuticals (AMEX:AVN) today reported a net
loss for the third quarter of fiscal 2005 of $8.2 million, or $0.08
per share, compared with a net loss of $6.6 million, or $0.08 per
share, for the same period a year ago.
Research and development (R&D) expenses in the third fiscal
quarter of 2005 were $6.5 million, compared to $5.1 million in the
same period a year ago. R&D program highlights for the third quarter
were:
-- Submitting the final reviewable unit of our new drug
application (NDA) to the U.S. Food and Drug Administration
(FDA) for Neurodex in the treatment of pseudobulbar affect,
including the payment of a $672,000 filing fee;
-- Initiating a Phase 3 clinical trial of Neurodex for the
treatment of neuropathic pain in patients with diabetes. The
trial has a Special Protocol Assessment (SPA) from the FDA,
which establishes agreement on the protocol under which AVANIR
will conduct the study and analyze the data;
-- Entering into a multi-million research, development and
commercialization agreement with Novartis to develop
treatments for inflammatory diseases by targeting macrophage
migration inhibitory factor (MIF).
A comparison of R&D spending by program is shown in the table that
follows.
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RESEARCH AND DEVELOPMENT PROGRAM EXPENSES
----------------------------------------------------------------------
Third Fiscal Quarter Ended
June 30, 2005 June 30, 2004
Amount Percent Amount Percent
(Mils.) (Mils.)
------- ------- ------- -------
Neurodex for the treatment of PBA $1.9 29% $2.1 41%
Neurodex for neuropathic pain 1.3 20% 0.5 10%
Allergy and asthma (IgE regulator)
program 1.0 15% 1.0 20%
Atherosclerosis research program 1.3 20% 0.3 6%
Other preclinical research, including
potential treatments for inflammation
and infectious diseases 1.0 16% 1.2 23%
------- ------- ------- -------
Total $6.5 100% $5.1 100%
======= ======= ======= =======
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Revenues for the third quarter of fiscal 2005 were $3.3 million,
compared to $591,000 in the same period a year ago. Revenues in the
third quarter of fiscal 2005 included $2.8 million in connection with
the Novartis collaboration, $456,000 that the Company recognized from
the sale of Abreva(R) royalty rights to Drug Royalty USA and $115,000
from government research grants. Revenues in the third quarter of
fiscal 2004 included $351,000 recognized from the sale of Abreva
royalty rights and $222,000 from government research grants.
Total operating expenses were $11.7 million in the third fiscal
quarter of 2005, compared to $7.3 million in the same period in fiscal
2004. In addition to increases in R&D expenditures, general and
administrative expenses increased by $1.6 million, largely due to
expenses associated with the departure of the previous CEO and the
costs of compliance with the Sarbanes Oxley Act of 2002. Sales and
marketing expenses increased by $1.5 million incurred in connection
with preparation for the potential launch of our lead product
candidate, Neurodex(TM).
Balance Sheet Highlights
As of June 30, 2005, we had cash and investments in securities
totaling $26.5 million, including cash and cash equivalents of $3.6
million, short and long-term investments in securities of $22.0
million and restricted investments in securities of $857,000.
Subsequent to the close of the quarter, we received a $10 million
payment from AstraZeneca related to our preclinical atherosclerosis
research program, which is not included in the cash and investments in
securities as of June 30, 2005.
Fiscal Year-to-Date Results
The net loss for the first nine months of fiscal 2005 was $29.3
million, compared to $19.6 million for the same period a year ago. The
basic and diluted net loss per share was $0.29 for the first nine
months of fiscal 2005, compared to $0.27 for the same period a year
ago.
Total operating expenses were $34.5 million in the first nine
months of fiscal 2005 compared to $22.7 million in the same period in
fiscal 2004. R&D expenses were $23.0 million in the first nine months
of fiscal 2005, compared to $15.8 million in the same period a year
ago. R&D programs accounted for 66% and 70% of total operating
expenses for the first nine months of fiscal 2005 and 2004,
respectively. A breakdown of major R&D spending for the nine-month
periods ended June 30, 2005 and 2004 is as follows:
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RESEARCH AND DEVELOPMENT PROGRAM EXPENSES
----------------------------------------------------------------------
Nine Months Ended
June 30, 2005 June 30, 2004
Amount Percent Amount Percent
(Mils.) (Mils.)
------- ------- ------- -------
Neurodex(TM) for the treatment of PBA $11.6 50% $6.3 40%
Neurodex for neuropathic pain 3.3 14% 1.6 10%
Allergy and asthma (IgE regulator)
program 2.1 9% 3.0 19%
Atherosclerosis research program 3.1 14% 0.8 5%
Other preclinical research, including
potential treatments for inflammation
and infectious diseases 2.9 13% 4.1 26%
------- ------- ------- -------
Total $23.0 100% $15.8 100%
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In addition to R&D expenditures, sales and marketing expenses
increased by $2.4 million due to costs incurred in connection with
preparation for the potential launch of Neurodex(TM). Administrative
expenses increased by $2.5 million, largely due to expenses associated
with the departure of the previous CEO and the costs of compliance
with the Sarbanes-Oxley Act of 2002.
Revenues for the first nine months of fiscal 2005 amounted to $4.9
million, compared to $3.0 million for the same period last year.
Revenues for the first nine months of fiscal year 2005 included $2.8
million in connection with the Novartis collaboration, $1.4 million
that the Company recognized from the sale of Abreva(R) royalty rights,
$400,000 from government research grants and $300,000 from research
contracts and licenses. Revenues for the first nine months of fiscal
2004 included $1.2 million from the sale of Abreva royalty rights,
$787,000 in sales of the raw material docosanol, $662,000 from
government research grants and $271,000 from research contracts and
licenses.
Conference Call and Webcast
Management will host a conference call with a simultaneous webcast
on Thursday, August 18, 2005 at 1:30 pm Pacific/4:30 pm Eastern to
discuss third quarter of fiscal 2005 operating performance. The
call/webcast will feature Chairman of the Board Charles Mathews, and
Vice President and Chief Financial Officer Gregory P. Hanson, CMA and
other members of management. The webcast will be available live via
the Internet by accessing AVANIR's website at www.avanir.com. Replays
of the webcast will be available for 90 days, and a phone replay will
be available through August 23, 2005 by dialing 888-203-1112
(domestic) and 719-457-0820 (international) and entering the passcode
6398574.
About the Company
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 disease. AVANIR recently
submitted to the FDA the final reviewable unit of its "rolling" New
Drug Application for Neurodex(TM) for the treatment of pseudobulbar
affect. Additionally, AVANIR has initiated a Phase 3 clinical trial of
Neurodex for the treatment of diabetic neuropathic pain. AVANIR has
active collaborations with two international pharmaceutical companies,
Novartis 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.
Except for the historical information presented herein, matters
discussed in this press release contain forward-looking statements
that are subject to certain risks and uncertainties that could cause
actual results to differ materially from any future results,
performance or achievements expressed or implied by such statements.
Statements that are not historical facts, including statements that
are preceded by, followed by, or that include such words like
"estimate," "anticipate," "believe," "intend," "plan," or "expect" or
similar statements are forward-looking statements. In regard to
financial projections, risks and uncertainties include risks
associated with royalties earned on product sales of docosanol, and
results of clinical trials or product development efforts, as well as
risks shown in AVANIR's most recent Annual Report on Form 10-K and
Quarterly Report on Form 10-Q and from time-to-time in other publicly
available information regarding the company. Copies of such
information are available from AVANIR upon request. Such publicly
available information sets forth many risks and uncertainties related
to AVANIR's business and technology. The company disclaims any intent
or obligation to update these forward-looking statements.
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AVANIR PHARMACEUTICALS
Summary Consolidated Financial Information (Unaudited)
Three months ended Nine months ended
June 30, June 30,
------------------------- ---------------------------
Consolidated
Statement of
Operations
Data: 2005 2004 2005 2004
---------------- ------------ ------------ ------------- -------------
Revenues $3,333,838 $591,354 $4,866,936 $2,956,835
------------ ------------ ------------- -------------
Operating
expenses:
Research and
development 6,470,317 5,096,979 22,952,728 15,839,108
General and
administrative 2,824,498 1,232,151 6,650,465 4,144,574
Sales and
marketing 2,414,578 936,802 4,911,797 2,517,399
Cost of product
sales ---- 3,102 3,102 213,192
------------ ------------ ------------- -------------
Total
operating
expenses 11,709,393 7,269,034 34,518,092 22,714,273
------------ ------------ ------------- -------------
Loss from
operations (8,375,555) (6,677,680) (29,651,156) (19,757,438)
Interest income 179,042 57,201 426,021 169,469
Other income 11,496 11,116 (50,575) 30,485
Interest
expense (22,513) (7,706) (69,458) (28,233)
------------ ------------ ------------- -------------
Net loss before
income tax (8,207,530) (6,617,069) (29,345,168) (19,585,717)
Provision for
income taxes (14) (424) (1,912) (2,544)
------------ ------------ ------------- -------------
Net loss $(8,207,544) $(6,617,493) $(29,347,080) $(19,588,261)
============ ============ ============= =============
Net loss per
share:
Basic and
diluted $(0.08) $(0.08) $(0.29) $(0.27)
============ ============ ============= =============
Basic and
diluted
weighted
average number
of common
shares
outstanding 107,367,798 78,256,417 100,485,329 73,740,318
============ ============ ============= =============
Consolidated Balance Sheet Data: June 30, September 30,
2005 2004
------------------------------------------ ------------- -------------
Cash and cash equivalents $3,576,849 $13,494,083
Short and long-term investments in
securities 22,032,820 11,555,849
Restricted investments in securities 856,872 856,597
------------- -------------
Total cash, cash equivalents and
investments in securities $26,466,541 $25,906,529
Net working capital $13,742,330 $16,653,621
Total assets $38,663,866 $37,403,953
Deferred revenue $19,525,064 $21,009,115
Total liabilities $28,297,043 $27,206,694
Shareholders' equity $10,366,823 $10,197,259
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