Wider-than-Expected Loss at Avanir

Zacks

Avanir Pharmaceuticals, Inc. (AVNR) 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 million.

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 expansion.

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.

Pipeline Update

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 the US.

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 dosages of GlaxoSmithKline plc’s (GSK) 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, companies like Questcor Pharmaceuticals Inc. (QCOR) and Anika Therapeutics Inc. (ANIK)  look well-positioned with a Zacks Rank #1 (Strong Buy).

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