Acura Pharmaceuticals Announces First Quarter 2013 Financial Results

Acura Pharmaceuticals Announces First Quarter 2013 Financial Results 
PALATINE, IL -- (Marketwired) -- 05/02/13 --  Acura Pharmaceuticals,
Inc. (NASDAQ: ACUR), a specialty pharmaceutical company developing
products intended to address medication abuse and misuse, announced
today financial results for the three months ended March 31, 2013. 
The Company reported a net loss of $4.2 million for the first quarter
2013 or $0.9 per diluted share, compared to net loss of $2.3 million
or $0.05 per diluted share for the same period in 2012. In connection
with our Pfizer Agreement, we began to earn royalties starting in
February 2013. These royalties are based on net sales of Oxecta by
Pfizer and are paid to Acura within 45 days after the end of each
calendar quarter. We have previously indicated that Oxecta sales were
expected to be nominal until Pfizer commences physician promotional
efforts. The Company recorded royalties of approximately $4 thousand
for the first quarter 2013 based on sales of approximately $77
thousand. 
Research and development expenses associated with product candidates
utilizing the company's AVERSION(R) and IMPEDE(R) Technologies were
$2.2 million in the first quarter 2013, compared to $0.9 million for
the same period in 2012. Selling, general and administrative expenses
were $2.2 million in the first quarter 2013, versus $1.4 million in
the same period last year. Selling expenses for the first quarter
2013 primarily consisted of advertising and marketing activities for
NEXAFED(R). 
As of April 30, 2013, the Company had cash, cash equivalents and
marketable securities of $21.5 million and no long term debt. 
During the first quarter 2013 the Company's submitted an
Investigational New Drug application ("IND") with the FDA to allow
clinical testing of Acura's hydrocodone bitartrate with acetaminophen
product formulated with AVERSION Technology
(hydrocodone/acetaminophen product). The Company commenced and
completed enrollment in an intranasal abuse liability study in
recreational drug users of the crushed hydrocodone/acetaminophen
product ("study AP- ADF-301"). We are awaiting comments from the FDA
regarding our statistical analysis plan for this study before
analyzing the results. We have initiated technical transfer for our
Aversion hydrocodone/acetaminophen product to the proposed commercial
manufacturer to commence scale-up activities. Based on the
development program, we anticipate preparing and submitting a
505(b)(2) NDA for our hydrocodone/acetaminophen product in the first
half of 2014. 
In December, 2012 the Company launched in the United States 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. NEXAFED is available through several regional and
national drug wholesalers for redistribution to pharmacies, including
the three largest U.S. drug wholesalers: McKesson, Cardinal Health
and AmerisourceBergen. In March 2013, we completed our first shipment
of Nexafed directly to the warehouse of a regional drug chain who, we
understand, would further stock all of their pharmacies with Nexafed.
We also have gained support from three additional chain customers,
including one operating food/drug combination stores that ranks in
the top ten based on retail pharmacy outlets and one that plans to
exclusively stock NEXAFED as its only 30mg tablet. We continue to
work to expand the wholesale and retail distribution network for
NEXAFED. We have shipped nearly 8 thousand cartons of NEXAFED
representing approximately $31 thousand in product gross sales during
the first quarter 2013. 
Conference Call Information
 Acura Pharmaceuticals, Inc. will host a
conference call on Friday, May 3, 2013 at 8:30 a.m. ET to discuss the
quarterly results. 
To participate in the live conference call, please dial 888-427-9417
(U.S. and Canada) five to ten minutes prior to the start of the call.
The participant passcode is 1259095. 
A replay of the call will be available beginning May 6, 2013 and
ending on May 27, 2013 on the company's website, and by dialing
888-203-1112 (U.S. and Canada). The replay participant code is
1259095. 
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(R) 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, adve
rse 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.  


 
                                                                            
                                                                            
                    CONDENSED CONSOLIDATED BALANCE SHEETS                   
                          (Unaudited, in thousands)                         
                                                                            
                                                   March 31,    December 31,
                                                      2013          2012    
                                                 ------------- -------------
Current assets                                   $      24,218 $      27,991
Property, plant and equipment, net                       1,018         1,052
Other assets                                                 9            11
                                                 ------------- -------------
  Total assets                                   $      25,245 $      29,054
                                                 ------------- -------------
                                                                            
Current liabilities                              $       2,175 $       1,419
Other liabilities                                            5             5
Stockholders' equity                                    23,065        27,630
                                                 ------------- -------------
  Total liabilities and stockholders' equity     $      25,245 $      29,054
                                                 ------------- -------------
                                                                            
                                                                            
                                                                            
                                                                            
           CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)           
             (Unaudited, in thousands except per share amounts)             
                                                                            
                                                    Three Months Ended      
                                                         March 31,          
                                                    2013           2012     
                                               -------------  ------------- 
Revenues:                                                                   
  Royalty revenue                              $           4  $           - 
                                                ------------   ------------ 
    Total revenues                                         4              - 
                                                ------------   ------------ 
      Operating expenses:                                                   
  Research and development                             2,206            903 
  Selling, general and administrative                  2,222          1,441 
                                               -------------  ------------- 
    Total operating expenses                           4,248          2,344 
                                               -------------  ------------- 
    Operating loss                                    (4,244)        (2,344)
Non-operating income:                                                       
  Inves
tment income                                       10             11 
  Gain on sales of marketable securities                  16              - 
                                               -------------  ------------- 
    Total other income                                    26             11 
                                               -------------  ------------- 
    Loss before income taxes                          (4,218)        (2,333)
  Provision for income taxes                               -              - 
                                               -------------  ------------- 
    Net loss                                   $      (4,218) $      (2,333)
                                               -------------  ------------- 
Other comprehensive income (loss):                                          
  Unrealized gains on securities                          52              - 
                                               -------------  ------------- 
    Total other comprehensive income (loss)               52              - 
                                               -------------  ------------- 
    Comprehensive income (loss)                $      (4,166) $      (2,333)
                                               -------------  ------------- 
                                                                            
                                               -------------  ------------- 
Earnings (loss) per share:                                                  
  Basic                                        $       (0.09) $       (0.05)
  Diluted                                      $       (0.09) $       (0.05)
                                               -------------  ------------- 
Weighted average shares outstanding:                                        
  Basic                                               46,685         47,517 
  Diluted                                             46,685         47,517 
                                               -------------  ------------- 

  
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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