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Avanir Pharmaceuticals Pre-Announces Preliminary Fiscal 2012 Fourth Quarter Results And Provides Clinical Study Update

ALISO VIEJO, Calif., Nov. 27, 2012 /PRNewswire/ --  Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced preliminary results for the quarter ended September 30, 2012.

Financial Update

Based on preliminary results for the fourth fiscal quarter ended September 30, 2012, Avanir estimates:
  • Gross revenue for NUEDEXTA® of $15.4 million, representing an increase of approximately 26% over the prior quarter
  • Total operating expenses, excluding cost of product sales and non-cash items such as share-based compensation, depreciation and amortization, between $21.7 to $22.2 million
  • More than 11,000 total prescriptions for the month of October 2012
  • Cash, cash equivalents and investments in securities totaling approximately $72.1 million, including cash and cash equivalents of approximately $69.8 million and restricted investments in securities of approximately $2.3 million

"We are delighted with the progress that we continue to make on a quarterly basis with our commercial efforts around NUEDEXTA," said Keith Katkin, president and CEO of Avanir. "Additionally, the team continues to be cost conscious and I anticipate that we will report total year operating expenses, excluding cost of product sales and non-cash items such as share-based compensation, depreciation and amortization  at the lower end of our $94 to $96 million guidance."

Clinical Update

The company also announced that it has initiated the first-in-human Phase I clinical trial of AVP-786 (formerly known as deuterated dextromethorphan). The trial is designed to assess the single and multiple dose pharmacokinetics, safety and tolerability of AVP-786 administered to healthy subjects.

Approximately 40 subjects will be enrolled in this randomized crossover study to compare multiple dose levels of AVP-786 (alone and in combination with quinidine) with dextromethorphan/quinidine. The pharmacokinetic study of AVP-786 is expected to be completed in the first calendar quarter of 2013.

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