AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) reported unaudited financial results for the three months ended December 31, 2009.
For the first quarter of fiscal 2010, AVANIR reported a net loss of $4.8 million, or $0.06 loss per share, compared with a net loss of $5.2 million, or $0.07 loss per share, for the same period in fiscal 2009. Net revenues for the first quarter of fiscal 2010 were $1.5 million, compared with $1.8 million for the same period in fiscal 2009. Total operating expenses were $6.3 million in the first quarter of fiscal 2010, compared with $7.0 million in the comparable fiscal 2009 period. Cash used in operations during the first quarter of fiscal 2010 was $6.5 million.
RECENT HIGHLIGHTS AND UPCOMING MILESTONES:
CLINICAL PROGRAMS AND PIPELINE
Zenvia in PBA
* Presented the full STAR trial results as a late breaker at the 134th Annual Meeting of the American Neurological Association; the full dataset from the Phase III STAR trial demonstrated that both doses of Zenvia (dextromethorphan/quinidine) met the primary efficacy endpoint of reduction of pseudobulbar affect (PBA) episode rates and also met statistical significance across multiple secondary endpoints
* Presented the STAR trial results for the MS subset of patients at the 3rd World Congress on Controversies in Neurology; in the subset of patients with PBA secondary to MS the Zenvia 30/10 mg dose met the primary efficacy endpoint of reduction of PBA episode rates and also demonstrated statistically significant relief of MS-related pain in the subset of MS patients with moderate-to-severe pain
* Presented the STAR trial results for the ALS subset of patients at the 20th International Symposium on ALS/MND; in the subset of patients with PBA secondary to ALS both Zenvia doses met the primary efficacy endpoint of reduction of PBA episode rates
* Announced safety and efficacy results of the open-label extension phase of the confirmatory Phase III STAR trial where the Zenvia 30/10 mg dose demonstrated sustained efficacy over a six month treatment period and a favorable long term safety and tolerability profile
COMPANY OPERATIONS
* Received a “Notice of Allowance” from the United States Patent and Trademark Office announcing that it intends to grant the Company a new patent extending patent protection for Zenvia in the United States well into 2025
* Announced that the Annual Meeting of Stockholders will be held Thursday, February 18, 2010 in Newport Beach, California
BALANCE SHEET HIGHLIGHTS
As of December 31, 2009, AVANIR had cash, cash equivalents and investments in securities totaling $25.6 million, including cash and cash equivalents of $25.1 million and restricted investments in securities of approximately $468,000.
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