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Acura Pharmaceuticals Announces Second Quarter 2013 Financial Results

Acura Pharmaceuticals Announces Second Quarter 2013 Financial Results 
PALATINE, IL -- (Marketwired) -- 08/01/13 --  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 and six months ended June 30,
2013.  
The Company reported a net loss of $3.1 million for the second
quarter 2013 or $0.07 per diluted share, compared to net loss of $2.2
million or $0.05 per diluted share for the same period in 2012.
Research and development expenses associated with product candidates
utilizing the company's AVERSION and IMPEDE Technologies were $0.8
million in the second quarter 2013, versus $0.9 million for the same
period in 2012. Selling, general and administrative expenses were
$2.3 million in the second quarter 2013, versus $1.3 million in the
same period last year. Selling expenses for the second quarter 2013
primarily consisted of advertising and marketing activities for
NEXAFED. 
The Company reported a net loss of $7.3 million or $0.16 per diluted
share, for the six months ended June 30, 2013, compared to a net loss
of $4.5 million or $0.10 per diluted share for the same period in
2012. Research and development expenses were $2.8 million in the six
months ended June 30, 2013, compared to $1.8 million in the same
period in 2012. Selling, general and administrative expenses were
$4.6 million in the six months ended June 30, 2013, versus $2.7
million in the same period last year.  
In connection with our Pfizer Agreement, we began to earn royalties
on net sales of OXECTA by Pfizer starting in February 2013. These
royalties are paid to Acura within 45 days after the end of each
calendar quarter. We previously indicated that OXECTA sales were
expected to be nominal until Pfizer commences promotional efforts to
health care providers and for the second quarter and six months we
recorded royalties of approximately $1 thousand and $5 thousand,
respectively. Following Pfizer's April 2013 receipt of the US Food
and Drug Administration's (FDA) advice on its OXECTA promotional
materials, we have been informed by Pfizer that it will expand
commercialization of OXECTA to health care providers in the fourth
quarter of 2013. These activiti
es will be directed to a national
cross section of healthcare professionals who treat pain, but will
not include the use of field representatives. 
As of July 30, 2013, the Company had cash, cash equivalents and
marketable securities of $18.4 million and no long term debt. 
The Company completed enrollment in an intranasal abuse liability
study in recreational drug users of our AVERSION(R)
hydrocodone/acetaminophen product and is conducting the statistical
analysis for this study with results expected in the 3rd quarter of
this year. At the same time, we have commenced scale-up activities
for this product to the proposed commercial manufacturer with the
expected completion of our registration batches by 3rd quarter of
this year. 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. 
We continue to evaluate possible partnering of our Aversion
development products with alternative strategic partners. 
Distribution of our meth-resistant NEXAFED (pseudoephedrine HCl)
expanded to approximately 1,400 US pharmacies or about 2% of the
65,000 pharmacy outlets. About 2/3 of these pharmacies are consistent
repeat customers with the top pharmacy averaging approximately 5
boxes per week. We continue to work to expand the wholesale and
retail distribution network for NEXAFED and intend to re-approach
some chain customers already stocking NEXAFED with programs designed
to improve penetration in those chains. We have shipped approximately
$25 thousand and $58 thousand in NEXAFED product during the quarter
and six months ended June 30, 2013, respectively. 
We are conducting research on Impede 2.0, our next generation IMPEDE
Technology, to further improve our NEXAFED franchise. Studies
sponsored by us at an independent laboratory using an optimized, high
yield direct conversion test method that is designed to replicate the
direct conversion, or one-pot, process commonly used by clandestine
methamphetamine laboratories yielded no measurable amount of
methamphetamine compared to an approximate 38% yield with our older
IMPEDE Technology. We have manufactured pilot scale quantities of
NEXAFED with IMPEDE 2.0 for further meth-resistance testing and
pharmacokinetic testing and, if successful, intend to incorporate
IMPEDE 2.0 into NEXAFED for commercial introduction. 
Conference Call Information
 Acura Pharmaceuticals, Inc. will host a
conference call on Friday, August 2, 2013 at 8:30 a.m. ET to discuss
the quarterly results. 
To participate in the live conference call, please dial 888-576-4387
(U.S. and Canada) five to ten minutes prior to the start of the call.
The participant passcode is 5000537. 
A replay of the call will be available beginning August 5, 2013 and
ending on August 26, 2013 on the company's website, and by dialing
888-203-1112 (U.S. and Canada). The replay participant code is
5000537. 
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. 
In December, 2012 the Company launched in the United States NEXAFED
(pseudoephedrine (HCl), a 30 mg immediate-release abuse-deterrent.
The next generation pseudoephedrine tablet combines 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.  
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(R) Tablets and Nexafed(R) 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 pr
oducts,
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 other product candidates, our
exposure to product liability and other lawsuits in connection with
the commercialization of our products, the increased 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 over-the-counter, or 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,"
"estimates," "projects," "predicts," "potential" and similar
expressions intended to identify forward-looking statements. These
statements reflect our current views and beliefs with respect to
future events and are based on assumptions and subject to significant
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                   
                          (Unaudited, in thousands)                         
                                                                            
                                                     June 30,   December 31,
                                                       2013         2012    
                                                   ------------ ------------
                                                                            
  Current assets                                         20,491       27,991
  Property, plant and equipment, net                      1,006        1,052
  Other assets                                                8           11
                                                   ------------ ------------
    Total assets                                   $     21,505 $     29,054
                                                   ------------ ------------
                                                                            
  Current liabilities                                     1,076        1,419
  Other liabilities                                           5            5
  Stockholders' equity                                   20,424       27,630
                                                   ------------ ------------
    Total liabilities and stockholders' equity     $     21,505 $     29,054
                                                   ------------ ------------
                                                                            
                                                                            
                                                                            
                        ACURA PHARMACEUTICALS, INC.                         
           CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)           
             (Unaudited, in thousands except per share amounts)             
                                                                            
                                          Unaudited           Unaudited     
                                        Three Months         Six Months     
                                       Ended June 30,      Ended June 30,   
                                       2013      2012      2013      2012   
                                     --------  --------  --------  -------- 
Revenues:                                                                   
  Royalty revenue                    $      1  $      -  $      5  $      - 
                                     --------  --------  --------  -------- 
    Total revenues                          1         -         5         - 
                                     --------  --------  --------  -------- 
Operating expenses:                                                         
  Research and development                805       919     2,831     1,822 
  Selling, general and                                                      
   administrative                       2,336     1,270     4,558     2,711 
                                     --------  --------  --------  -------- 
    Total operating expenses            3,141     2,189     7,389     4,533 
                                     --------  --------  --------  -------- 
    Operating loss                     (3,140)   (2,189)   (7,384)   (4,533)
                                     --------  --------  --------  -------- 
Non-operating income:                                                       
  Investment income                        71        11        81        22 
  Gain (loss) on sales of marketable                                        
   securities                              (7)        -         9         - 
  Other income (expense)                    -        (1)        -        (1)
                                     --------  --------  --------  -------- 
    Total other income                     64        10        90        21 
                                     --------  --------  --------  -------- 
    Loss before income taxes           (3,076)   (2,179)    (7294)   (4,512)
  Provision for income taxes                
-         -         -         - 
                                     --------  --------  --------  -------- 
    Net loss                         $ (3,076) $ (2,179) $ (7,294) $ (4,512)
                                     --------  --------  --------  -------- 
Other comprehensive income (loss):                                          
  Unrealized gains (losses) on                                              
   securities                            (131)        -       (79)        - 
                                     --------  --------  --------  -------- 
    Total other comprehensive income                                        
     (loss)                              (131)        -       (79)        - 
                                     --------  --------  --------  -------- 
    Comprehensive income (loss)      $ (3,207) $ (2,179) $ (7,373) $ (4,512)
                                     --------  --------  --------  -------- 
                                                                            
                                                                            
                                     --------  --------  --------  -------- 
Income (loss) per share:                                                    
    Basic                            $  (0.07) $  (0.05) $  (0.16) $  (0.10)
    Diluted                          $  (0.07) $  (0.05) $  (0.16) $  (0.10)
                                     --------  --------  --------  -------- 
Weighted average shares outstanding:                                        
    Basic                              47,228    47,521    47,215    47,519 
    Diluted                            47,228    47,521    47,215    47,519 
                                     --------  --------  --------  -------- 

  
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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