AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today reported unaudited financial results for the three and twelve months ended September 30, 2009.
For the fourth quarter of fiscal 2009, AVANIR reported a net loss from continuing operations of $7.0 million, or $0.09 per share, compared with a net loss from continuing operations of $5.2 million, or $0.07 per share, for the same period in fiscal 2008. Net revenues from continuing operations for the fourth quarter of fiscal 2009 were $1.0 million, compared with $1.2 million for the same period in fiscal 2008. Total operating expenses from continuing operations were $7.7 million in the fourth quarter of fiscal 2009, compared with $6.7 million in the comparable fiscal 2008 period. Cash used in continuing operations during the fourth quarter of fiscal 2009 was $4.7 million, compared to $4.3 million of cash used in continuing operations in the fourth quarter of fiscal 2008.
For fiscal 2009, AVANIR reported a net loss from continuing operations of $22.0 million, or $0.28 per share, compared with a net loss of $15.9 million, or $0.27 per share, for fiscal 2008. The increase in net loss is primarily attributed to increased spending in fiscal 2009 on the confirmatory Phase III STAR clinical trial, as well as additional pre-clinical and clinical studies to enhance our complete response to the approvable letter received in 2006 for Zenvia in pseudobulbar affect (PBA). In addition, share-based compensation expense increased by $1.2 million in fiscal 2009 as compared to the prior year, of which $935,000 of expense was recorded in the fourth fiscal quarter resulting from a decrease in estimated forfeiture rates. Net revenues from continuing operations for fiscal 2009 were $4.2 million, compared with $7.0 million for fiscal 2008. Total operating expenses from continuing operations were $26.0 million in fiscal 2009, compared with $24.7 million in fiscal 2008. Cash used in continuing operations during fiscal 2009 was $20.3 million, compared to $16.5 million in fiscal 2008.
"The past year has been one of great success and accomplishment for AVANIR. I am very pleased with the progress we made by advancing our promising investigational drug Zenvia™ through Phase III development in pseudobulbar affect as well as achieving or exceeding our financial and corporate objectives," said Keith Katkin, AVANIR's President and CEO. "With the full data set in hand from the STAR double blind study as well as the open-label extension, we believe the new lower dose Zenvia formulations should address the concerns raised by the FDA in their approvable letter. We plan to submit our complete response to the FDA approvable letter early in the second calendar quarter of 2010 and expect an approval decision approximately six months later. We also expect that we have sufficient cash on hand to fund operations to mid fiscal year 2011 and believe we are well positioned for success in 2010.”
FISCAL 2009 HIGHLIGHTS AND SUBSEQUENT EVENTS:
CLINICAL PROGRAMS AND PIPELINE
Zenvia in PBA