Acura Pharmaceuticals Announces Fourth Quarter and Full Year 2012 Financial Results

PALATINE, IL, Mar 04 (Marketwire) --
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 hydrocodone 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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