Acura Pharmaceuticals Announces Third Quarter 2012 Financial

Acura Pharmaceuticals Announces Third Quarter 2012 Financial Results 
PALATINE, IL -- (Marketwire) -- 11/06/12 --  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 nine months ended September
30, 2012.  
The Company reported a net loss of $2.2 million for the third quarter
2012 or $0.04 per diluted share, compared to net loss of $2.2 million
or $0.05 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
$0.7 million in the third quarter 2012, compared to $1.0 million for
the same period in 2011. Marketing, general and administrative
expenses were $1.5 million in the third quarter 2012, versus $1.2
million in the same period last year. Marketing expenses during the
three months ended September 30, 2012 primarily consisted of
advertising and marketing activities we initiated on NEXAFED(R).
Marketing expenses during the three months ended September 30, 2011
primarily consisted of market research studies on our AVERSION(R) and
IMPEDE(TM) Technologies. Our NEXAFED(R) advertising and marketing
activities will continue in the fourth quarter of 2012 and we expect
similar activities in 2013. 
As of September 30, 2012, the Company had cash and cash equivalents
of $29.3 million and no long term debt. 
For the nine months ended September 30, 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
approval of a New Drug Application for OXECTA(R) (oxycodone HCI, USP)
Tablets CII. Research and development expenses were $2.5 million in
the nine months ended September 30, 2012, compared to $3.2 million in
the same period in 2011. Marketing, general and administrative
expenses were $4.2 million in the nine months ended September 30,
2012, versus $4.8 million in the same period last year. The Company
reported a net loss of $6.7 million or $0.14 per diluted share, for
the nine months endin
g September 30, 2012, compared to a net income
of $12.0 million or $0.25 per diluted share for the same period in
2011. 
In the third quarter, the Company commenced its manufacturing process
validation for NEXAFED, an over-the-counter immediate-release
pseudoephedrine (PSE) tablet that is intended to impede the illicit
manufacture of methamphetamine from PSE. NEXAFED will be the first
marketed product utilizing Acura's proprietary IMPEDE technology. The
Company expects to make NEXAFED commercially available to pharmacies
in December, 2012. We intend to market NEXAFED pursuant to the FDA's
OTC Monograph regulations that do not require the submission of an
ANDA or NDA with the FDA.  
On September 26, 2012 the Company announced a letter agreement with
Pfizer Inc. providing for the termination of Pfizer's license to
Acura's AVERSION Technology used in three developmental opioid
products as of that date and the earlier transfer of those products
back to Acura. On July 26, 2012 Acura was notified by Pfizer of its
intention to terminate the license to the three development products
which carried a 12 month notice period under the terms of the
companies' 2007 license agreement. The developmental products being
returned to Acura are oxycodone hydrochloride with acetaminophen,
hydrocodone bitartrate with acetaminophen and a third previously
unnamed opioid, all of which utilize Acura's AVERSION technology. 
Paragraph IV ANDA Filing
 On September 20, 2012, we announced that we
had received a Paragraph IV Certification Notice under 21 U.S.C.
355(j) (a Paragraph IV Notice) from a generic sponsor of an ANDA for
a generic drug listing OXECTA as the reference listed drug. Since
such date, we have received similar Paragraph IV Notices from three
other generic pharmaceutical companies that have filed ANDAs listing
OXECTA as the reference drug. The Paragraph IV Notices refer to our
U.S. Patent Numbers 7,201,920, 7,510,726 and 7,981,439, which cover
our AVERSION Technology and OXECTA. The Paragraph IV Notices state
that each generic sponsor believes that such patents are invalid,
unenforceable or not infringed. We will take appropriate action to
enforce our intellectual property rights and on October 31, 2012, we
initiated suit against each of Watson Laboratories, Inc. - Florida,
Par Pharmaceutical, Inc., Impax Laboratories, Inc. and Sandoz Inc. in
the United States District Court for the District of Delaware
alleging infringement of our patent no. 7,510,726 listed in the FDA's
Orange Book. The commencement of such litigation prohibits the FDA
from granting approval of the filed ANDAs until the earliest of 30
months from the date the FDA accepted the application for filing, or
the conclusion of litigation. 
Citizen's Petition filing with FDA
 On September 21, 2012, Pfizer, as
licensee of our AVERSION Technology used in OXECTA under the Pfizer
Agreement, filed a Citizen's Petition with the FDA requesting that
the FDA: (i) refrain from permitting an ANDA applicant to rely on
OXECTA as a reference listed drug unless the ANDA applicant
demonstrates that its product uses the same inactive ingredients as
those in OXECTA; (ii) require an ANDA applicant seeking approval of a
product that relies on OXECTA as the reference listed drug and uses
inactive ingredients different from those in OXECTA to submit an NDA
under Section 505(b)(2) of the Federal Food, Drug and Cosmetics Act;
and (iii) refrain from rating a product as therapeutically equivalent
to OXECTA unless it has the same inactive ingredients as OXECTA. The
FDA has not yet responded to this Citizen's Petition and there can be
no assurance that the FDA will take some or all of the actions
requested. 
Conference Call Information 
 Acura Pharmaceuticals, Inc. will host a
conference call on Wednesday, November 7, 2012 at 8:30 a.m. ET to
discuss the quarterly results and Pfizer's return of the development
products. 
To participate in the live conference call, please dial 888-359-3624
(U.S. and Canada) five to ten minutes prior to the start of the call.
The participant passcode is 4454583.  
A replay of the call will be available beginning November 8, 2012 at
11:30 a.m. ET and ending on November 20, 2012 on the company's
website, and by dialing 888-203-1112 (U.S. and Canada). The replay
participant code is 4454583. 
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. In June 2011, the U.S. Food and Drug
Administration approved OXECTA(R) which incorporates the AVERSION(R)
technology. The Company has a development pipeline of additional
AVERSION(R) technology products including other opioids and its
IMPEDE(TM) technology for pseudoephedrine hydrochloride products. 
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 resul
ts,
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(R), the ability
of us or our licensee's to obtain necessary regulatory approvals and
commercialize products utilizing our technologies and the market
acceptance of and competitive environment for any of our products,
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, 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, 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 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)                               
                                                                            
                                                  (unaudited)    (audited)  
                                                 September 30,  December 31,
                                                      2012          2011    
                                                 ------------- -------------
Current assets                                   $      29,838 $      36,129
Property, plant and equipment, net                       1,076         1,044
                                                 ------------- -------------
  Total assets                                          30,914 $      37,173
                                                 ------------- -------------
                                                                            
Current liabilities                              $         687 $         530
Stockholders' equity                                    30,227        36,643
                                                 ------------- -------------
  Total liabilities and stockholders' equity     $      30,914 $      37,173
                                                 ------------- -------------
                                                                            
                                                                            
                                                                            
                        ACURA PHARMACEUTICALS, INC.                         
                   CONSOLIDATED STATEMENTS OF OPERATIONS                    
                   (in thousands, except per share data)                    
                                                                            
                                         (unaudited)         (unaudited)    
                                      Nine Months Ended  Three Months Ended 
                                        September 30,       September 30,   
                                       2012      2011      2012      2011   
                                     --------  --------  --------  -------- 
Revenues                                                                    
  Program fee revenue                       -  $    466         -         - 
  Milestone revenue                         -    20,000         -         - 
                                     --------  --------  --------  -------- 
    Total revenues                          -    20,466         -         - 
                                     --------  --------  --------  -------- 
Operating expenses                                                          
  Research and development              2,518     3,245       696       962 
  Marketing, general and                                                    
   administrative                       4,164     4,840     1,453     1,185 
                                     --------  --------  --------  -------- 
    Total operating expenses            6,682     8,085     2,149     2,147 
                                     --------  --------  --------  -------- 
Income (loss) from operations          (6,682)   12,381    (2,149)   (2,147)
  Other income (expense), net              30        (9)        9         6 
                                     --------  --------  --------  -------- 
Income (loss) before income tax        (6,652)   12,372    (2,140)   (2,141)
  Income tax expense                        -       341         -         - 
                                     --------  --------  --------  -------- 
Net income (loss)                    $ (6,652) $ 12,031  $ (2,140) $ (2,141)
                                     --------  --------  --------  -------- 
                                                                            
                                                                            
                                     --------  --------  --------  -------- 
Income (loss) per sh
are                                                     
    Basic                            $  (0.14) $   0.25  $  (0.04) $  (0.05)
    Diluted                          $  (0.14) $   0.25  $  (0.04) $  (0.05)
                                     --------  --------  --------  -------- 
                                                                            
                                     --------  --------  --------  -------- 
Weighted average shares                                                     
    Basic                              47,520    47,392    47,522    47,802 
    Diluted                            47,520    47,627    47,522    47,802 
                                     --------  --------  --------  -------- 

  
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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