AVANIR Pharmaceuticals reports net loss of $6.4 million for second-quarter fiscal 2010

AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today reported unaudited financial results for the three and six months ended March 31, 2010.

“We continue to make excellent progress with our Zenvia clinical development program in PBA and are very excited that we have filed our Complete Response with the FDA”

For the second quarter of fiscal 2010, AVANIR reported a net loss of $6.4 million, or $0.08 loss per share, compared with a net loss of $4.9 million, or $0.06 loss per share, for the same period in fiscal 2009. Net revenues for the second quarter of fiscal 2010 were $1.0 million, compared with $812,000 for the same period in fiscal 2009. Total operating expenses were $7.4 million in the second quarter of fiscal 2010, compared with $5.8 million in the comparable fiscal 2009 period. The increase in total operating expenses was primarily due to costs associated with Zenvia pre-commercialization expenses. Cash used in operations during the second quarter of fiscal 2010 was $4.7 million.

For the first six months of fiscal 2010, AVANIR reported a net loss of $11.3 million, or $0.14 per share, compared with a net loss of $10.1 million, or $0.13 per share for the comparable period in fiscal 2009. Total net revenues for the first six months of fiscal 2010 were $2.5 million compared with $2.6 million for the first six months of fiscal 2009. Total operating expenses were $13.8 million in the first six months of fiscal 2010, compared to $12.8 million in the comparable fiscal 2009 period. In addition, cash used in operations was $11.2 million in the first six months of fiscal 2010 and $11.2 million in the first six months of fiscal 2009.

"We continue to make excellent progress with our Zenvia clinical development program in PBA and are very excited that we have filed our Complete Response with the FDA," said Keith Katkin, AVANIR's President and CEO. "With the FDA decision on the PBA application expected before the end of the year, we are now engaging in market development activities to support a commercial launch planned for the first quarter of 2011. The recent issuance of a new U.S. patent gives us additional intellectual property protection which sets the stage for approximately 15 years of revenue generation after our planned launch. Overall, we believe that we are well positioned to create substantial value for our stockholders and potentially help the significant number of patients in the U.S. who are currently suffering from PBA."

RECENT HIGHLIGHTS AND UPCOMING MILESTONES:

CLINICAL PROGRAMS AND PIPELINE

Zenvia in PBA

• Announced that the Company filed the Complete Response to the October 30, 2006 NDA Approvable Letter with an approval decision on the PBA application consequently expected in the fourth calendar quarter of 2010.
• Presented detailed Zenvia safety and efficacy data from the double-blind and open-label extension of the Phase III confirmatory STAR trial in three data posters at the American Academy of Neurology Annual Meeting in Toronto.

COMPANY OPERATIONS

• Announced that the United States Patent and Trademark Office issued the Company a new patent in the United States that extends patent protection for Zenvia in the treatment of PBA into late 2025.
• Announced that the Company hired Michael McFadden as Vice President of U.S. Sales and Managed Markets to construct, staff and lead the AVANIR field sales and managed care account teams.

BALANCE SHEET HIGHLIGHTS

As of March 31, 2010, AVANIR had cash, cash equivalents and investments in securities totaling $20.7 million, including cash and cash equivalents of $20.3 million and restricted investments in securities of approximately $402,000.

AVANIR Pharmaceuticals, Inc.,