CONTACT:
Acura Pharmaceuticals, Inc.
Peter A. Clemens, SVP Investor Relations & CFO
(847-705-7709)
FOR IMMEDIATE RELEASE

ACURA PHARMACEUTICALS, INC.
REPORTS FIRST QUARTER 2008 FINANCIAL RESULTS
Palatine, IL, April 30, 2008:
Acura Pharmaceuticals, Inc.
(NASDAQ: ACUR) reported net income of $7.4
million, or $0.15 per diluted share for the quarter ending March 31,
2008 compared to a net loss of $9.2 million, or $0.26 loss per diluted
share for the same quarter in 2007.
The 2008 results include revenues relating to the
license,
development and commercialization agreement (the “Agreement”) closed in
December, 2007 with King Pharmaceuticals Research and Development, Inc.
(“King”), a wholly-owned subsidiary of King Pharmaceuticals, Inc. In
2008 we recognized $17.1 million in revenues including $13.7 million in
Program Fee Revenue derived from the non-refundable $30.0 million
upfront payment received from King in December, 2007. Program Fee
Revenues are being recognized ratably over our estimate of the
development period for each of the product candidates identified for
development in the Agreement. In addition, in 2008 we recognized $3.4
million in Collaboration Revenue from King’s reimbursement of Acura's
research and development expenses for Acurox™ Tablets. The Company's
total research and development expenses for the first quarter were $4.1
million and $1.2 million for 2008 and 2007, respectively. The increase
was primarily attributable to Phase III clinical development costs for
Acurox™ Tablets.
As of
April 30, 2008, the Company had cash and cash equivalents of
approximately $30 million with no term indebtedness. Our cash reserves
are expected to be used to fund the development of additional Aversion®
Technology product candidates, to prosecute our pending Aversion®
Technology patent applications and to fund related operating and
business development expenses.
The
Company’s condensed consolidated balance sheets and statements of
operations appear below. All reported share and per share data have
been adjusted to reflect a one-for-ten reverse stock split effected on
December 5, 2007. Detailed financial statements are included in the
Company’s Quarterly Report on Form 10-Q for the quarter ended March 31,
2008 filed with the Securities and Exchange Commission.
Acurox™ Tablet Development Update
On
April 24, 2008, the Company announced completion of patient enrollment
for our Acurox™ Tablet pivotal Phase III safety and efficacy study and
stated that top line results from this study will be announced by July,
2008. Assuming this Phase III study meets its primary endpoint, the
Company expects to submit to the FDA a 505(b)(2) NDA for Acurox™ Tablets
prior to the end of 2008. As part of this submission the Company
intends to request a priority review of the application by the FDA,
although no assurance can be provided that this request will be
granted.
About Acura Pharmaceuticals, Inc.
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in research, development and manufacture of innovative Aversion®
(abuse deterrent) Technology and related product candidates.
Forward Looking Statements
This
press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying
assumptions prove inaccurate or unknown risks or uncertainties
materialize, actual results could vary materially from our Company’s
expectations and projections. The most significant of such risks and
uncertainties include, but are not limited to, our ability, and the
ability of King Pharmaceuticals Research and Development, Inc. and other
pharmaceutical companies, if any, with whom we may license our Aversion®
Technology, to obtain necessary regulatory approvals and commercialize
products utilizing the Aversion® Technology, the ability to avoid
infringement of patents, trademarks and other proprietary rights of
third parties, and the ability to fulfill the FDA’s 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 clinical studies completed to date and
the results of other clinical studies, to support FDA approval of our
product candidates, the adequacy of the development program for our
product candidates, changes in regulatory requirements, adverse safety
findings relating to our product candidates, the risk that the FDA may
not agree with our analysis of its clinical studies and may evaluate the
results of these studies by different methods or conclude that the
results of the studies are not statistically significant, clinically
meaningful or that there were human errors in the conduct of the studies
or otherwise, the risk that further studies of our product candidates
are not positive, and the uncertainties inherent in scientific research,
drug development, clinical trials, the regulatory approval process, and
commercial supply. You are encouraged to review other important risk
factors relating to our operations on our web site at
www.acurapharm.com under the
link, “Company Risk Factors” and detailed in our filings with the
Securities and Exchange Commission.
We assume no obligation to
update any forward-looking statements as a result of new information or
future events or developments. Our press releases may be reviewed at
www.acurapharm.com.
|
ACURA PHARMACEUTICALS, INC. |
|
CONDENSED CONSOLIDATED
BALANCE SHEETS |
|
(in thousands) |
|
|
|
|
|
|
| |
(Unaudited) |
(Audited) |
| |
March 31, |
December 31, |
|
|
2008 |
2007 |
|
Current
Assets |
$
38,403 |
$
44,582 |
|
Property,
Plant and Equipment, net |
1,063 |
1,046 |
|
Total
Assets |
$
39,466 |
$
45,628 |
|
|
|
|
|
Accrued
Expenses |
311 |
334 |
|
Deferred
Pogram Fee Revenue |
12,865 |
26,574 |
|
Stockholders' Equity |
26,290 |
18,720 |
|
Total
Liabilities and Stockholders' Equity |
$
39,466 |
$
45,628 |
|
ACURA PHARMACEUTICALS, INC. |
|
CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(in thousands, except per
share data) |
|
|
|
|
(Unaudited)
For the Three Months Ended
March 31, |
|
|
2008 |
2007 |
|
Revenues |
|
|
|
Program Fee Revenue |
$
13,707 |
$
- |
|
Collaboration Revenue |
3,377 |
- |
|
Total Revenues |
17,084 |
- |
| |
|
|
|
Operating Expenses |
|
|
|
Research
and Development |
4,082 |
1,196 |
|
Marketing, General and Administrative |
870 |
778 |
|
Total Operating Expenses |
4,952 |
1,974 |
|
Operating Income (Loss) |
12,132 |
(1,974) |
|
|
|
Other
Income (Expense) |
|
|
|
Interest
Income (Expense), net |
297 |
(362) |
|
Amortization of Debt Discount |
- |
(1,692) |
|
Loss on
Fair Value Change of Conversion Features |
- |
(3,483) |
|
Loss on
Fair Value Change of Common Stock Warrants |
- |
(1,668) |
|
Gain
on Asset Disposals |
- |
20 |
|
Total Other Income (Expense) |
297 |
(7,185) |
| |
|
|
|
Income (Loss) Before Income
Tax Expense |
12,429 |
(9,159) |
|
Income Tax
Expense |
4,980 |
- |
|
Net
Income (Loss) |
$
7,449 |
$
(9,159) |
|
|
|
Income (Loss) Per Common
Share Applicable to Common Stockholders |
|
|
|
Basic
|
$ 0.16 |
$
(0.26) |
|
Diluted |
$ 0.15 |
$
(0.26) |
| |
|
|
| Weighted
Average Number of Outstanding Common Shares |
|
|
|
Basic
|
45,657 |
35,229 |
|
Diluted |
49,439 |
35,229 |

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