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Avanir Pharmaceuticals Reports Fiscal 2011 Third Quarter Financial Results
Date:8/8/2011

fiscal 2010.
  • Total operating expenses were $48.1 million in the first nine-months of fiscal 2011 compared to $20.3 million in the comparable period for fiscal 2010.
  • Cash used in operations was $42.5 million in the first nine-months of fiscal 2011.
  • Net loss for the first nine-months of fiscal 2011 was $42.6 million, or $0.36 per share, compared with a net loss of $17.0 million, or $0.20 per share for the comparable period in fiscal 2010.

  • NUEDEXTA RevenueFor the quarter ended June 30, 2011, the company reported NUEDEXTA gross and net revenue of $2.2 million and $1.9 million respectively. NUEDEXTA revenue is recognized using a deferred revenue recognition model, meaning that NUEDEXTA capsule shipments to wholesalers are initially recorded as deferred revenue and later recognized as revenue when the product has left the distribution channel and is no longer subject to a right of return, effectively representing reported end-user prescriptions and non-retail shipments of NUEDEXTA capsules.

    Business HighlightsRecent highlights for the company include:

  • In July, the company met with the European Medicines Agency (EMA) to discuss plans for filing a marketing authorization application (MAA) for NUEDEXTA for the treatment of pseudobulbar affect. Based on the outcome of the meeting, the company plans to request an accelerated review process and to file for approval of NUEDEXTA using the data package which served as the basis for the U.S. Food and Drug Administration approval of NUEDEXTA.  The timing of the company's MAA filing is subject to reaching an agreement with the EMA on a pediatric investigation plan for NUEDEXTA, which may occur before the end of calendar year 2011.
  • In April, the company filed an Investigational New Drug application with the U.S. Food and Drug Administration to begin a large Phase II clinical trial of AVP-923. The objectives of the PRIME study (Pain Research In Multiple sclErosis) a
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  • SOURCE Avanir Pharmaceuticals, Inc.
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