Avanir Pharmaceuticals, Inc. (AVNR) announced preliminary results for the fiscal year ended Sep 30, 2013 with net revenues coming in between $75.3–$76.3 million, ahead of the Zacks Consensus Estimate of $75 million. Operating expenses were about $116.0 million in fiscal 2013.
Investor Day Highlights
Alongwith a preliminary update on fiscal 2013, Avanir conducted its investor day on Oct 29, 2013.
Avanir’s lead drug Nuedexta (AVP-923) generated gross revenues of $92.1 million in fiscal year 2013. We note that Nuedexta was launched in the U.S. in Feb 2011 for the treatment of pseudobulbar affect (PBA). In Jun 2013, Avanir received approval for Nuedexta in the EU for the treatment of patients suffering from PBA.
Nuedexta is being studied for three additional indications in phase II, namely, (i) AVR-131 study – for the treatment of agitation in Alzheimer's disease (second half calendar 2014), (Iii) AVR-133 study – levodopa induced dyskinesia (:LID) in patients suffering from Parkinson's disease (second half calendar 2014) and (iii) AVR-130 study – central neuropathic pain in multiple sclerosis (fourth quarter of calendar 2013).
An interesting pipeline candidate at Avanir is AVP-825. It is being developed using OptiNose's novel Breath Powered intranasal delivery system, which includes low dosages of GlaxoSmithKline’s (GSK) Imitrex (sumatriptan) for the treatment of acute migraine. A new drug application is expected to be filed in the fourth quarter of calendar year 2014.
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.