Avanir Pharmaceuticals, Inc. (AVNR) reported fourth quarter fiscal 2013 net loss per share of 10 cents, wider than the Zacks Consensus Estimate of a loss of 7 cents and the year-ago loss of 9 cents. For the fiscal year ended Sep 2013, Avanir reported a loss of 39 cents, wider than the Zacks Consensus Estimate of a loss of 36 cents but narrower than the year-ago loss of 45 cents.
Fourth quarter revenues rose 60% year over year to $21.7 million, marginally below the Zacks Consensus Estimate of $22 million. For fiscal 2013, Avanir reported revenues of $75.4 million, marginally below the Zacks Consensus Estimate of $76 million but above year-ago revenues of $41.2 million
Quarter in detail
Net revenues included Nuedexta revenue and royalty revenue from Abreva. Net Nuedexta revenues grew 5.9% sequentially to $20.2 million. Nuedexta is approved for the treatment of patients suffering from pseudobulbar affect (PBA). This was the tenth consecutive quarter of double-digit year over year sales growth for Nuedexta.
Research and development (R&D) expenses were $27.9 million as compared to $6.1 million in the year ago quarter, driven by pipeline development. Selling and marketing expenses shot up 357.4% to $17.6 million, driven by personnel costs. General and administrative expenses rose 50.7% year over year to $9.4 million.
Avanir is looking to expand Nuedexta’s label in a phase II study, evaluating the use of Nuedexta for the treatment of levodopa induced dyskinesia (:LID) in patients suffering from Parkinson's disease
In Jul 2013, Avanir joined forces with OptiNose for the development and commercialization of AVP-825 for the treatment of acute migraine. A New Drug Application (:NDA) is expected to be filed in the first quarter of calendar year 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 Merck KgAa (MKGAF) to co-promote Merck's Januvia in the US.
Avanir also announced that the phase II study (PRIM) on Nuedexta for the treatment of central neuropathic pain in patients with multiple sclerosis failed to achieve the primary endpoint. Patients treated with Neudexta experienced similar levels of pain reduction as compared to placebo.
Another candidate, AVP-786 is being developed for the treatment of neurologic and psychiatric disorders. An investigational new drug application for AVP-786 will be filed in the second half of fiscal year 2014.
Avanir carries a Zacks Rank #5 (Strong Sell). The share price of Avanir fell 2.5% on the failure of the PRIME study. Although Avanir reported wider loss, Nuedexta revenues were encouraging. Nuedexta revenues in this quarter grew 63% year over year.