Avanir Pharmaceuticals, Inc.
) reported second quarter fiscal 2014 net loss per share of 8
cents, in line with the Zacks Consensus Estimate but narrower than
the year-ago loss of 12 cents.
Revenues in the reported quarter rose 55% year over year to
$26.9 million, below the Zacks Consensus Estimate of $30
Quarter in Detail
Net revenues included Nuedexta revenues, co-promotion revenues
and royalty revenues from Abreva. Net Nuedexta revenues grew 47.4%
year over year to $24.4 million. Nuedexta is approved for the
treatment of patients suffering from pseudobulbar affect (PBA).
Research and development (R&D) expenses were $9.9 million,
up 11.5% year over year. Selling and marketing expenses rose 17.7%
year over year to $18.9 million. General and administrative
expenses increased 22.6% year over year to $8.6 million.
Avanir gave its expense guidance (excluding cost of product
sales) for the year ending Sep 30, 2014, in the range of $140
million to $150 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 of this year) and the other for levodopa induced
dyskinesia (LID) in patients suffering from Parkinson's
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. The Prescription Drug User Fee Act (PDUFA) action date is on
Nov 26, 2014.
Another candidate, AVP-786 is being developed for the treatment
of neurologic and psychiatric disorders. Avanir will commence
a study this year on AVP-786 for the treatment of resistant major
Avanir carries a Zacks Rank #3 (Hold). Revenues from Nuedexta
were encouraging. Avanir is also making efforts to expand
Nuedexta's label. We also note that the data from the two phase II
studies on Nuedexta will be out this year. Positive news on the
PDUFA action date regarding AVP-825 will be encouraging as it will
reduce Avanir's dependence on Nuedexta, its solitary approved
Some better-ranked stocks worth considering include
Alexion Pharmaceuticals, Inc.
Gilead Sciences Inc.
). Alexion Pharma and Gilead Sciences carry a Zacks Rank #1 (Strong
Buy) while Allergan holds a Zacks Rank #2 (Buy).
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