PALATINE, IL -- (Marketwire) -- 03/04/13 -- Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced today financial results for the year and three months ended December 31, 2012.
The Company reported a net loss of $3.0 million for the fourth quarter 2012 or $0.06 per diluted share, compared to net loss of $1.6 million or $0.03 per diluted share for the same period in 2011. We recorded no revenue in either period.
Research and development expenses associated with product candidates utilizing the company's AVERSION® and IMPEDE Technologies were $1.2 million in the fourth quarter 2012, compared to $0.8 million for the same period in 2011. Selling, general and administrative expenses were $1.8 million in the fourth quarter 2012, versus $1.1 million in the same period last year. Selling expenses for the three months ended December 31, 2012 primarily consisted of advertising and marketing activities for NEXAFED®.
As of December 31, 2012, the Company had cash, cash equivalents and marketable securities of $27.4 million and no long term debt.
For the twelve months ended December 31, 2012, Acura recorded no revenue compared with revenue of $20.5 million in the same period in 2011. Prior year results included $20 million in milestone revenue from Pfizer Inc. following the U.S. Food and Drug Administration's ("FDA") approval of a New Drug Application for OXECTA® (oxycodone HCI, USP) Tablets CII. Research and development expenses were $3.7 million in the twelve months ended December 31, 2012, compared to $4.0 million in the same period in 2011. Selling, general and administrative expenses were $6.0 million in the twelve months ended December 31, 2012, versus $5.9 million in the same period last year. The Company reported a net loss of $9.7 million or $0.20 per diluted share, for the twelve months ending December 31, 2012, compared to a net income of $10.4 million or $0.22 per diluted share for the same period in 2011.
During the fourth quarter the Company submitted an Investigational New Drug application ("IND") with the FDA to allow clinical testing of Acura's hydrocodone bitartrate with acetaminophen formulated with AVERSION Technology. The IND was accepted in January, 2013 and the Company has initiated the intranasal abuse liability testing in recreational drug users of the crushed drug product.
In December, 2012 the Company launched NEXAFED [pseudoephedrine hydrochloride (HCl)], a 30 mg immediate-release next generation pseudoephedrine product, combining effective nasal-congestion relief with a unique technology that disrupts the conversion of pseudoephedrine into the dangerous drug, methamphetamine. As of February 28, 2013 the Company has entered into distribution agreements with most of the national and regional drug wholesalers and NEXAFED is available to pharmacies nationwide.
About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary AVERSION® and IMPEDE technologies. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.
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