Avanir Pharmaceuticals, Inc. reported second quarter fiscal 2013 net loss per share of 12 cents, wider than the Zacks Consensus Estimate of a loss of 9 cents, but narrower than the year-ago loss of 13 cents.
Second quarter revenues rose 73.6% year over year to $17.4 million, marginally above the Zacks Consensus Estimate of $17 million.
Net revenues included Nuedexta revenue and royalty revenue from Abreva. Net Nuedexta revenues grew 11% sequentially to $16.5 million. Nuedexta is approved for the treatment of patients suffering from pseudobulbar affect (PBA).
Research and development expenses increased 38.8% year over year to $8.9 million, due to costs associated with many ongoing clinical studies and regulatory expenses. Selling, general and administrative expenses grew 14.3% year over year to $23 million. The increase was driven by the company's DTC campaign, the primary care pilot and sales force expansion.
Higher than expected litigation cost, commercial initiatives and the positive CHMP opinion resulted in the company raising its operating expenses guidance to $105 million - $115 million from the earlier guidance of $100 million to $110 million.
AVP-923 is in phase II for the treatment of agitation in patients with Alzheimer's disease and levodopa-induced-dyskinesia (LID) in Parkinson's disease (PD). Avanir expects top-line data for both indications in the first half of 2014.
Avanir plans to speed up the PRIME study (neuropathic pain related to multiple sclerosis) being conducted with AVP-923. Avanir expects to report top-line data from the PRIME study in the fourth quarter of calendar 2013.
In Apr 2013, Avanir received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Nuedexta, where it is under review for the treatment of patients suffering from PBA. The committee has also recommended approval for two dosage strengths - 20/10 mg and 30/10 mg capsules. Avanir expects to gain approval in roughly three months.
Avanir currently carries a Zacks Rank #4 (Sell). Currently, companies like Lannett Company, Inc. (LCI - Snapshot Report), Santarus, Inc. and Catalyst Pharmaceutical Partners Inc. (CPRX - Analyst Report)) look more attractive with a Zacks Rank #1 (Strong Buy).