AVANIR REPORTS 4TH QTR FISCAL 2006 NET LOSS OF $22.2
MIL.
Pharmaceuticals (NASDAQ:AVNR), San Diego, Calif., has reported
unaudited financial results for the quarter and fiscal year ended
September 30, 2006.
Fourth Quarter 2006 Results
For the fourth quarter ended September 30, 2006, AVANIR's net
loss was $22.2 million, or $0.70 per share, compared to $1.3 million, or
$0.05 per share, for the same period in 2005. The commercial launch
activities for Zenvia (formerly referred to as Neurodex) increased
AVANIR's operating expenses in the period, which contributed to a
significant part of the increase in net loss compared with the same
period a year ago.
Subsequent to the close of the fourth quarter of fiscal 2006,
AVANIR: Received an approvable letter from the U.S. Food and Drug
Administration for Zenvia for the treatment of involuntary emotional
expression disorder (IEED). They have scheduled a meeting with the FDA
in the first quarter of calendar 2007 and will provide an update on the
path forward once that is determined.
Completed an equity offering raising approximately $14.4 million of
net proceeds. As required by the note obligation associated with our
acquisition of Alamo Pharmaceuticals, we used $2.9 million of the funds
raised to repay part of this outstanding debt.
Announced initiatives taken to reduce ongoing operating expenses,
including suspending commercial initiatives focused on Zenvia for
involuntary emotional expression disorder; placing on hold activities
associated with the selective cytokine inhibitor clinical development
program; and reducing the overall workforce by approximately 16%.
Enrolled the last patient in our ongoing Zenvia Phase III painful
diabetic neuropathy trial. Data from the trial is currently anticipated
by mid-2007.
Revenues for the fourth quarter of fiscal 2006 were $2.2 million,
compared to $11.8 million in the same period a year ago. Revenues in the
fourth quarter of fiscal 2006 included $1.7 million in research services
from collaborations with Novartis and AstraZeneca, recognition of
$464,000 from the sale of abreva royalty rights to Drug Royalty USA, and
revenues from license fees and government research grants totaling
$29,000. In connection with the acquisition of Alamo Pharmaceuticals in
May 2006 the company began to market FazaClo (clozapine, USP). Since
completing the acquisition, the company has recorded all wholesaler
shipments of FazaClo as deferred revenue and will continue to do so
until the company has evidence of the expiration of the right-of-return
or can reasonably estimate future product returns. The company has
recorded as net deferred revenues wholesaler shipments for FazaClo
totaling $2.8 million for the fourth quarter of fiscal 2006. The company
currently believes it will begin to recognize revenue for this product
in the first fiscal quarter of 2007.
Total operating expenses were $24.2 million in the fourth fiscal
quarter of 2006, compared to $13.3 million in the same period in fiscal
2005. This increase of $10.9 million included a $2.3 million increase
related to the expansion of our commercial organization in preparation
for the planned launch of Zenvia, $4.8 million from the addition of
Alamo operations, $1.1 million in stock-based compensation, a $3.7
million increase in research and development, primarily for medical
affairs, and a $211,000 increase in general and administrative expense;
offset in part by a $1.3 million adjustment to fair value of acquired
in-process research and development in connection with the Alamo
acquisition. Balance Sheet Highlights As of September 30, 2006, we had
cash and investments in securities totaling $24.8 million, including
cash and cash equivalents of $4.9 million, short- and long-term
investments in securities of $19.0 million and restricted investments in
securities of $857,000.
Fiscal Year 2006 Results
For the fiscal year ended September 30, 2006, AVANIR's loss
before cumulative effect of change in accounting principle was $58.9
million, or $1.92 per share, compared to a net loss of $30.6 million, or
$1.19 per share, for the fiscal year ended September 30, 2005. The net
loss for fiscal 2006 was $62.6 million, or $2.04 per share, compared to
a net loss of $30.6 million, or $1.19 per share, for the fiscal year
ended September 30, 2005.
Total revenues for fiscal 2006 amounted to $15.2 million, compared
to $16.7 million for fiscal 2005. Revenues for the fiscal year 2006
included $5.0 million relating to the achievement of a milestone under
the AstraZeneca license agreement, $7.8 million in research service
revenues generated from our collaborative agreements with Novartis and
AstraZeneca executed in April 2005 and July 2005, respectively, and $1.9
million from the recognition of revenue related to the sale of an
undivided interest in our abreva license agreement to Drug Royalty USA.
Revenues for fiscal 2005 included $12.8 million in connection with the
AstraZeneca, Novartis and other licenses, $1.8 million that the company
recognized from the sale of abreva royalty rights, $1.6 million from
research services and $503,000 from government research grants. Since
completing the acquisition of Alamo, the company has recorded as net
deferred revenues wholesaler shipments for FazaClo totaling $4.0
million.
Operating expenses for fiscal 2006 amounted to $75.2 million,
compared to $47.8 million in the same period in fiscal 2005. R&D
expenses were $36.7 million in fiscal 2006, compared to $29.0 million in
the same period a year ago. The increase included a $1.3 million charge
for acquired in-process research and development in connection with the
acquisition of Alamo.
Selling, general and administrative expenses increased by $19.3
million. The increase is primarily due to $6.2 million in costs incurred
in connection with preparation for the potential launch of Zenvia, $5.7
million in expense from the addition of Alamo operations, a $3.9 million
increase in medical educational grants, $2.5 million in stock-based
compensation expense and a $1.4 million increase in salaries and
benefits primarily related to an increase in headcount.
About AVANIR
AVANIR Pharmaceuticals is focused on developing, acquiring and
commercializing novel therapeutic products for the treatment of chronic
diseases. AVANIR's products and product candidates address
therapeutic markets that include the central nervous system,
cardiovascular disorders, inflammation and infectious diseases. AVANIR
currently markets FazaClo, the only orally-disintegrating formulation of
clozapine for the management of severely ill schizophrenic patients who
fail to respond adequately to standard schizophrenic drug treatments.
FazaClo is also indicated for reducing the risk of suicidal behavior in
patients with schizophrenic or schizoaffective disorder.
Zenvia, AVANIR's lead product candidate for the treatment of
involuntary emotional expression disorder (IEED), is the subject of an
approvable letter from the FDA and future development plans for this
product candidate are under consideration. The company does not know at
this time what impact, if any, the ongoing discussions with the FDA for
IEED may have on the development of Zenvia for other indications.
Additionally, AVANIR has completed the patient recruitment in a Phase
III clinical trial with Zenvia as a potential treatment for patients
with painful diabetic neuropathy. 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, is marketed in
North America by GlaxoSmithKline Consumer Healthcare and is the leading
over-the-counter product for the treatment of cold sores.
For more information, visit http://www.avanir.com or call
949/389-6789.
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