Avanir Pharmaceuticals, Inc.
reported third quarter fiscal 2013 net loss per share of 8 cents,
wider than the Zacks Consensus Estimate of a loss of 7 cents, but
narrower than the year-ago loss of 11 cents.
Third quarter revenues rose 87% year over year to $19.8
million, marginally below the Zacks Consensus Estimate of $20
Net revenues included Nuedexta revenue and royalty revenue
from Abreva. Net Nuedexta revenues grew 15.2% sequentially to $19
million. Nuedexta is approved for the treatment of patients
suffering from pseudobulbar affect (PBA).
Research and development expenses declined 11.4% year over
year to $6.1 million. Selling, general and administrative
expenses grew 28.5% year over year to $23 million. The increase
was driven by increased marketing cost and sales force
Avanir raised the lower end of its operating expense guidance
to $110 million to $115 million from the earlier guidance of $105
million to $115 million for 2013.
In the reported quarter, Avanir received EU approval for
Nuedexta for the treatment of PBA.
Avanir expects to report top-line data from the PRIME study in
the fourth quarter of calendar 2013.
Avanir recently held a pre-IND (Investigational New Drug)
meeting with the U.S. Food and Drug Administration (FDA) for
AVP-786. Following interactions with the FDA, an agreement was
reached for a faster development path for Avanir's AVP-786. The
candidate is being developed for the treatment of neurologic and
psychiatric disorders. Under the agreement with the FDA, Avanir
will be allowed to use the data generated on Nuedexta to support
the IND application as well as regulatory filings for AVP-786 in
In Jul 2013, Avanir joined forces with OptiNose for the
development and commercialization of AVP-825 for the treatment of
acute migraine. AVP-825 is being developed using OptiNose's novel
Breath Powered intranasal delivery system, which includes low
Imitrex for the treatment of acute migraine. Once approved, it
will be the first and only fast-acting, dry-powder nasal delivery
form of Imitrex.
Avanir currently carries a Zacks Rank #2 (Buy). Currently,
Questcor Pharmaceuticals Inc. (
Anika Therapeutics Inc. (
look well-positioned with a Zacks Rank #1 (Strong
ANIKA THERAPEUT (ANIK): Free Stock Analysis
AVANIR PHARM (AVNR): Free Stock Analysis
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