Avanir Pharmaceuticals, Inc.
) reported first quarter fiscal 2014 net loss per share of 7
cents, narrower than the Zacks Consensus Estimate of a loss of 8
cents and the year-ago loss of 9 cents.
First quarter revenues rose 62% year over year to $26.7
million, above the Zacks Consensus Estimate of $24 million.
Quarter in Detail
Net revenues included Nuedexta revenues, co-promotion revenues
and royalty revenues from Abreva. Net Nuedexta revenues grew
56.6% year over year to $23.3 million. Nuedexta is approved for
the treatment of patients suffering from pseudobulbar affect
Research and development (R&D) expenses were $9.5 million
as compared to $6.6 million in the year-ago quarter, driven by
pipeline development. Selling and marketing expenses rose 29.2%
year over year to $17.5 million, driven by increased personnel
costs. General and administrative expenses increased 29.2% year
over year to $8.4 million.
Avanir is looking to expand Nuedexta's label. Nuedexta is
currently being studied for two additional indications in phase
II, one for the treatment of agitation in Alzheimer's disease
(top line data - second half calendar 2014) and other for the
levodopa induced dyskinesia (LID) in patients suffering from
Parkinson's disease (second half calendar 2014). Avanir enrolled
the first patient in a proof of concept phase II study in
Avanir joined forces with OptiNose for the development and
commercialization of AVP-825 for the treatment of acute migraine
in Jul 2013. A New Drug Application (NDA) for AVP-825 was filed
in Jan 2014. Once approved, it will be the first and only
fast-acting, dry-powder nasal delivery form of Imitrex.
Avanir entered into a multi-year agreement with
) to co-promote Merck's Januvia in the U.S. in Aug 2013. In
the reported quarter, Avanir commenced promoting Januvia and the
sitagliptin family of products in the long-term care setting in
Another candidate, AVP-786 is being developed for the
treatment of neurologic and psychiatric disorders. Avanir
will soon commence a study on AVP-786 for the treatment resistant
major depressive disorder.
Avanir carries a Zacks Rank #3 (Hold). Revenues from Nuedexta
were encouraging. This was the eleventh consecutive quarter of
double-digit sales growth for Nuedexta. Avanir is also making
efforts to expand Nuedexta's label. The NDA filing of AVP-825 is
encouraging as the potential approval will reduce Avanir's
dependence on Nuedexta, its solitary product.
Some better-ranked players in the biopharma industry include
). Endocyte carries a Zacks Rank #1 (Strong Buy) while Biodel
carries a Zacks Rank #2 (Buy).
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