Acura Pharmaceuticals Announces Fourth Quarter and Full Year 2012 Financial Results

Acura Pharmaceuticals Announces Fourth Quarter and Full Year 2012 Financial 
Results 
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(R) and IMPEDE(TM) 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(R).  
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(R) (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 hy
drocodone 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(R)
and IMPEDE(TM) 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. 
In June 2011, the U.S. Food and Drug Administration approved
OXECTA(R) (oxycodone HC1 tablets) which incorporates the AVERSION(R)
technology. The Company has a development pipeline of additional
AVERSION(R) technology products containing other opioids.  
The trademark OXECTA(R) is owned by Pfizer Inc. 
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. Forward-looking statements may
include, but are not limited to, our and our licensee's ability to
successfully launch and commercialize our products and technologies
including Oxecta Tablets and Nexafed Tablets, the price discounting
that may be offered by Pfizer for Oxecta, our and our licensee's
ability to obtain necessary regulatory approvals and commercialize
products utilizing our technologies and the market acceptance of and
competitive environment for any of our products, the willingness of
wholesalers and pharmacies to stock Nexafed Tablets, expectations
regarding potential market share for our products and the timing of
first sales, our ability to enter into additional license agreements
for our Aversion Technology product candidates, our exposure to
product liability and other lawsuits in connection with the
commercialization of our products, the increasing cost of insurance
and the availability of product liability insurance coverage, the
ability to avoid infringement of patents, trademarks and other
proprietary rights of third parties, and the ability of our patents
to protect our products from generic competition, our ability to
protect and enforce our patent rights in any paragraph IV patent
infringement litigation, 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, the results of laboratory and
clinical studies we may complete in the future to support FDA
approval of our product candidates and the sufficiency of our
development to meet OTC Monograph standards as applicable, 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, whether the FDA will agree with our analysis of our
clinical and laboratory studies and how it may evaluate the results
of these studies or whether further studies of our product candidates
will be required to support FDA approval, whether or when we are able
to obtain FDA approval of labeling for our product candidates for the
proposed indications and will be able to promote the features of our
abuse discouraging technologies, whether our product candidates will
ultimately deter abuse in commercial settings and whether our Impede
technology will disrupt the processing of pseudoephedrine into
methamphetamine. In some cases, you can identify forward-looking
statements by terms such as "may," "will," "should," "could,"
"would," "expects," "plans," "anticipates," "believes," "indicates,"
"estimates," "projects," "predicts," "potential" and similar
expressions intended to identify forward-looking statements. These
statements reflect our current views with respect to future events
and are based on assumptions and subject to risks and uncertainties.
Given these uncertainties, you should not place undue reliance on
these forward-looking statements. We discuss many of these risks in
greater detail in our filings 
with the Securities and Exchange
Commission. 


 
                                                                            
                                                                            
                         ACURA PHARMACEUTICALS, INC.                        
                    CONDENSED CONSOLIDATED BALANCE SHEETS                   
                               (in thousands)                               
                                                                            
                                                   (audited)     (audited)  
                                                  December 31,  December 31,
                                                      2012          2011    
                                                 ------------- -------------
Current assets                                   $      27,991 $      36,129
Property, plant and equipment, net                       1,052         1,044
Other assets                                                11             -
                                                 ------------- -------------
    Total assets                                 $      29,054 $      37,173
                                                 ------------- -------------
                                                                            
Current liabilities                              $       1,419 $         530
Other liabilities                                            5             -
Stockholders' equity                                    27,630        36,643
                                                 ------------- -------------
    Total liabilities and stockholders' equity   $      29,054 $      37,173
                                                 ------------- -------------
                                                                            
                                                                            
                                                                            
                        ACURA PHARMACEUTICALS, INC.                         
           CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)           
                   (in thousands, except per share data)                    
                                                                            
                                       (audited)            (unaudited)     
                                  Twelve Months Ended   Three Months Ended  
                                     December 31,          December 31,     
                                    2012       2011       2012       2011   
                                 ---------  ---------  ---------  --------- 
Revenues:                                                                   
  Program fee revenue            $       -  $     466  $       -  $       - 
  Milestone revenue                      -     20,000          -          - 
                                 ---------  ---------  ---------  --------- 
    Total revenues                       -     20,466          -          - 
                                 ---------  ---------  ---------  --------- 
Operating expenses:                                                         
  Research and development           3,726      4,037      1,208        792 
  Selling, general and                                                      
   administrative                    6,013      5,895      1,849      1,055 
                                 ---------  ---------  ---------  --------- 
    Total operating expenses         9,739      9,932      3,057      1,847 
                                 ---------  ---------  ---------  --------- 
    Operating income (loss)         (9,739)    10,534     (3,057)    (1,847)
Non-operating income (expense):                                             
  Interest income                       79         32         48         10 
  Other expense, net                    (8)       (34)        (7)        (3)
                                 ---------  ---------  ---------  --------- 
    Total other income                                                      
     (expense), net                     71         (2)        41          7 
                                 ---------  ---------  ---------  --------- 
    Income (loss) before income                                             
     taxes                          (9,668)    10,532     (3,016)    (1,840)
  Provision (benefit) for income                                            
   taxes                                 -        147          -       (194)
                                 ---------  ---------  ---------  --------- 
    Net income (loss)            $  (9,668) $  10,385  $  (3,016) $  (1,646)
                                 ---------  ---------  ---------  --------- 
Other comprehensive income                                                  
 (loss), net of tax:                                                        
  Unrealized gains (losses) on                                              
   securities                          (40)         -          -          - 
                                 ---------  ---------  ---------  --------- 
    Total other comprehensive                                               
     income (loss)                     (40)         -          -          - 
                                 ---------  ---------  ---------  --------- 
    Comprehensive income (loss)  $  (9,708) $  10,385  $  (3,016) $  (1,646)
                                 ---------  ---------  ---------  --------- 
                                                                            
                                                                            
                                 ---------  ---------  ---------  --------- 
Earnings (loss) per share:                                                  
  Basic                          $   (0.20) $    0.22  $   (0.06) $   (0.03)
  Diluted                        $   (0.20) $    0.22  $   (0.06) $   (0.03)
                                 ---------  ---------  ---------  --------- 
Weighted average shares                                                     
 outstanding:                                                               
  Basic                             47,521     47,496     47,523     47,806 
  Diluted                           47,521     48,007     47,523     47,806 
                                 ---------  ---------  ---------  --------- 

  
Contact: 
for Acura Investor Relations
investors@acurapharm.com 
847-705-7709 
for Acura Media Relations
pr@acurapharm.com 
847-705-7709 
 
 
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