The Company's condensed consolidated balance sheets and statements of operations appear below. Detailed financial statements are included in the Company's Annual Report on Form 10-K for the year ended December 31, 2010 filed with the Securities and Exchange Commission.
Acurox® (oxycodone HCl) Tablets
Acurox ® Tablets is an orally administered immediate release tablet containing oxycodone hydrochloride (HCl) as its sole active analgesic ingredient and is intended for the relief of moderate to severe pain. On December 17, 2010, King submitted a New Drug Application ("NDA") for Acurox ® Tablets to the FDA, including a request for priority review classification. On February 10, 2011 the FDA notified King of the FDA's acceptance for filing of the Acurox ® Tablets NDA and the grant of a priority review classification. The priority review classification establishes a non-binding date of June 17, 2011 for the FDA to complete its review of the Acurox® Tablets NDA under the Prescription Drug User Fee Act (PDUFA).
Impede ™ TechnologyWe 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 are currently negotiating with our preferred contract manufacturer for the scale up, manufacture and packaging of commercial quantities of our Impede™ PSE Tablets. It is our expectation to market, sell and distribute our Impede™ PSE Tablets directly to national and regional drug store chains. About Acura Pharmaceuticals, Inc. Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of product candidates intended to introduce limits or impediments to abuse and misuse utilizing our proprietary Aversion ® and Impede™ Technologies, and other novel technologies. The Acura Pharmaceuticals, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4847 Forward Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. The most significant of such factors include, but are not limited to, our ability and the ability of King (to whom we have licensed our Aversion® Technology for certain opioid analgesic products in the United States, Canada and Mexico) and the ability other pharmaceutical companies, if any, to whom we may license our Aversion® Technology or Impede™ Technology, to obtain necessary regulatory approvals and commercialize products utilizing such technologies, the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties, and the ability to fulfill the FDA requirements for approving our product candidates for commercial manufacturing and distribution in the United States, including, without limitation, the adequacy of the results of the laboratory and clinical studies completed to date and the results of laboratory and clinical studies we may complete in the future to support FDA approval of our product candidates, the adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support FDA approval of our product candidates, changes in regulatory requirements, adverse safety findings relating to our product candidates, the risk that the FDA may not agree with our analysis of our clinical studies and may evaluate the results of these studies by different methods or conclude that the results of the studies are not statistically significant, clinically meaningful or that there were human errors in the conduct of the studies or the risk that further studies of our product candidates are not positive or otherwise do not support FDA approval, whether or when we are able to obtain FDA approval of labeling for our product candidates for the proposed indications or for abuse limiting features, whether our product candidates will ultimately deter abuse in commercial settings, and the uncertainties inherent in scientific research, drug development, laboratory and clinical trials and the regulatory approval process. Other important factors that may also affect future results include, but are not limited to: our ability to attract and retain skilled personnel; our ability to secure and protect our patents, trademarks and other proprietary rights; litigation or regulatory action that could require us to pay significant damages or change the way we conduct our business; our ability to compete successfully against current and future competitors; our dependence on third-party suppliers of raw materials; our ability to secure U.S. Drug Enforcement Administration quotas and source the active ingredients for our products in development; difficulties or delays in conducting clinical trials for our product candidates or in the commercial manufacture and supply of our products; and other risks and uncertainties detailed in our filings with the Securities and Exchange Commission. When used in this press release, the words "estimate," "project," "anticipate," "expect," "intend," "believe," and similar expressions identify forward-looking statements.
|ACURA PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(audited) at December 31,|
|Property, Plant and Equipment, net||1,052||1,160|
|Deferred Program Fee Revenue||466||1,555|
|Total Liabilities and Stockholders' Equity||$25,493||$31,917|
|ACURA PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
|(unaudited) Three Mths Ended Dec 31,||(audited) Twelve Mths Ended Dec 31,|
|Program Fee Revenue||$233||$389||$1,088||$3,077|
|Research and Development||1,463||1,845||7,177||5,673|
|Marketing, General and Administrative||1,833||2,982||8,858||11,662|
|Total Operating Expenses||3,296||4,827||16,035||17,335|
|Loss from Operations||(2,937)||(4,077)||(12,724)||(13,500)|
|Other Income (Expense)|
|Total Other Income||11||13||28||144|
|Loss Before Income Tax||(2,926)||(4,064)||(12,696)||(13,356)|
|Income Tax Expense||1||20||11||2,479|
|Net Loss Applicable to Common Stockholders||$(2,927)||$(4,084)||$(12,707)||$(15,835)|
|Loss Per Common Share Applicable to Common Stockholders|
|Basic and diluted||$(0.06)||$(0.09)||$(0.27)||$(0.35)|
|Weighted Average Number of Outstanding Common Shares|
|Basic and diluted||47,139||46,209||47,029||45,932|
CONTACT: Peter A. Clemens, SVP & CFO 847-705-7709
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