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Acura Pharmaceuticals reports net loss of $3.2M for second-quarter 2010

Published on July 30, 2010 at 2:47 AM · No Comments

Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) today reported a second quarter 2010 net loss of $3.2 million or $0.07 per share compared to net loss of $6.5 million, or $0.14 per share for the second quarter of 2009. For the six months ended June 30, 2010, the Company reported a net loss of $7.2 million, or $0.15 per share compared to net loss of $7.8 million, or $0.17 per share for the same period in 2009. At July 29, 2010 we had cash and cash equivalents of approximately $26.5 million with no term indebtedness.

The results include revenues relating to our License, Development and Commercialization Agreement with King Pharmaceuticals Research and Development, Inc. ("King"), a wholly-owned subsidiary of King Pharmaceuticals, Inc. For the six months ending June 30, 2010, we recognized revenues of $2.6 million, of which $0.6 million was from the amortized portion of the $30.0 million upfront cash payment received from King in December, 2007 and $2.0 million was from King's reimbursement of our research and development ("R&D") expenses for Acurox® with Niacin (oxycodone HCl/niacin) Tablets and Acurox® (oxycodone HCL) Tablets. For the same period in 2009 we recognized revenues of $2.3 million, of which $2.1 million was from the amortized portion of the $30.0 million upfront cash payment and $0.2 million was from reimbursement of our R&D expenses.

For the second quarters ending June 30, 2010 and 2009, we recognized revenues of $0.6 million and $0.9 million, respectively, of which $0.2 million and $0.8 million, respectively, was from the amortized portion of the $30 million upfront cash payment and $0.4 million and $0.1 million, respectively, was from reimbursement of our R&D expenses.   

Research and development expenses for the six and three months ended June 30, 2010 increased by $2.0 million and $0.3 million, respectively, over the same periods in 2009 (after excluding share-based compensation expenses) due primarily to costs associated with conducting clinical studies on Acurox® with Niacin (oxycodone HCl/niacin) Tablets and other product candidates. Marketing, general and administration expenses for the six and three months ended June 30, 2010 remained relatively unchanged from the same periods in 2009 (after excluding share-based compensation expense). The quarter and six months ended June 30, 2009 included income tax expenses recorded when we increased our deferred income tax asset valuation reserve.

The Company's condensed consolidated balance sheets and statements of operations appear below.  Detailed financial statements are included in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed with the Securities and Exchange Commission.

Impede™ Technology

We have developed a pseudoephedrine hydrochloride (PSE) tablet product candidate utilizing our Impede™ Technology. Impede™ Technology utilizes a proprietary mixture of functional inactive ingredients intended to limit or impede extraction of PSE from the tablets for use as a starting material in producing the illicit drug methamphetamine. The unique mixture of inactive ingredients in the Impede™ PSE product candidate are generally recognized as safe.

We sponsored an independent pharmaceutical laboratory test of our Impede™ PSE tablets compared to Sudafed® brand PSE tablets in an attempt to extract PSE from 100 x 30 mg tablets for conversion to methamphetamine using what we believe to be the three most commonly used conversion processes. The results of these tests demonstrated that while PSE was readily extracted from Sudafed® tablets, Impede™ PSE effectively impeded the extraction of the PSE for conversion into methamphetamine. We are currently optimizing our tablet formulation and evaluating potential commercialization and regulatory strategies for Impede™ PSE Tablets.

Acurox® (oxycodone HCl) Tablets

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