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

ACURA PHARMACEUTICALS, INC.
REPORTS THIRD QUARTER 2008 FINANCIAL RESULTS
Palatine, IL, October 27, 2008:
Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) today reported 2008 third
quarter net income of $3.1 million, or $0.06 per diluted share compared
to a net loss of $2.5 million, or a ($0.06) loss per share for the same
quarter in 2007. For the nine months ending September 30, 2008, the
Company reported net income of $17.5 million, or $0.35 per diluted share
compared to a net loss of $13.8 million or a ($0.37) loss per share for
the same period in 2007. As of October 24, 2008, we had cash and cash
equivalents of approximately $35.0 million with no term indebtedness.
Our
financial 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. For the nine
months ending September 30, 2008, we recognized $36.6 million in
revenues resulting from the Agreement comprised of (i) $23.7 million in
Program Fee Revenue including our amortization of $20.7 million of the
non-refundable upfront payment received from King in December, 2007 and
the $3.0 million fee received upon King's exercise of its option to
license a third opioid analgesic product candidate utilizing Aversion®
(abuse deterrent) Technology; (ii) $5.0 million in Milestone Revenue
recognized upon successful achievement of the primary pain relief
endpoints in our Acurox™ (oxycodone HCl/niacin) Tablets pivotal phase
III clinical study and (iii) $8.0 million in Collaboration Revenue from
King's reimbursement of our research and development expenses related
to product candidates licensed to King. The 2008 third quarter results
include the recognition of $1.2 million and $2.6 million of Program Fee
Revenue and Collaboration Revenue, respectively. We had no revenues in
the same period in 2007.
Our
research and development expenses increased $8.1 million and $2.9
million for the nine and three months ended September 30, 2008,
respectively, compared with the same periods in 2007. These increases
were primarily attributable to the pivotal Phase III clinical study and
Phase I and II clinical studies assessing the abuse deterrent features
of Acurox™ Tablets. In the nine and three months results for 2008, a
$5.0 million tax benefit was recorded to reflect the expected future
utilization of prior years net operating losses which will reduce future
taxes payable.
Our condensed consolidated balance sheets and statements
of operations appear below. Detailed financial statements are included
in our Quarterly Report on Form 10-Q for the quarter ended September 30,
2008 filed with the Securities and Exchange Commission.
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.
About 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. The most significant of such factors
include, but are not limited to, our ability, the ability of King
Pharmaceuticals (to whom we have licensed our Aversion® Technology for
certain opioid analgesic products in the United States, Canada and
Mexico) and the ability of other pharmaceutical companies, if any, to
whom we may license our Aversion® Technology, to obtain necessary
regulatory approvals and commercialize products utilizing Aversion®
Technology, the ability to avoid infringement of patents, trademarks and
other proprietary rights of third parties, and the ability to fulfill
the U.S. Food and Drug Administration’s (“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 and the results of other laboratory and 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 unpredictability of the duration and results of FDA
review of filings made with the FDA relating to our product candidates,
the risk that the FDA may not agree with our analysis of our 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 or otherwise
do not support FDA approval or commercially viable product labeling, and
the uncertainties inherent in scientific research, drug development,
clinical trials and the regulatory approval process. Other important
factors that may also affect future results include, but are not limited
to: our ability to attract and retain highly skilled personnel; our
ability to timely submit the New Drug Application for Acurox with the
FDA; our ability to secure and protect our patents, trademarks and
proprietary rights; litigation or regulatory action that could require
us to pay significant damages or change the way we conduct our business;
our ability to compete successfully against current and future
competitors; our dependence on third-party suppliers of raw materials;
our ability to secure U.S. Drug Enforcement Administration ("DEA")
quotas and source the active ingredients of our products in development;
difficulties or delays in clinical trials for our product candidate or
in the commercial manufacture and supply of our products; and other
risks and uncertainties detailed in our 2007 SEC Form 10-K and our
September 30, 2008 SEC Form 10-Q. When used in this press release, the
words "estimate," "project," "anticipate," "expect," "intend,"
"believe," and similar expressions are intended to identify
forward-looking statements. You are encouraged to review other
important risk factors 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.
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ACURA PHARMACEUTICALS, INC. |
|
CONDENSED CONSOLIDATED
BALANCE SHEETS |
|
(in thousands) |
|
|
|
|
|
|
| |
(Unaudited) |
(Audited) |
| |
September 30, |
December 31, |
|
|
2008 |
2007 |
|
Current
Assets |
$
42,051 |
$
44,582 |
|
Deferred
Income Taxes |
3,400 |
- |
|
Property,
Plant and Equipment, net |
1,102 |
1,046 |
|
Total
Assets |
$
46,553 |
$
45,628 |
|
|
|
|
|
Accrued
Expenses |
2,084 |
334 |
|
Deferred
Program Fee Revenue |
5,895 |
26,574 |
|
Stockholders' Equity |
38,574 |
18,720 |
|
Total
Liabilities and Stockholders' Equity |
$
46,553 |
$
45,628 |
|
ACURA PHARMACEUTICALS, INC. |
|
CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(in thousands, except per
share data) |
|
|
|
|
(Unaudited)
For the Nine Months Ended
September 30, |
(Unaudited)
For the Three Months Ended
September 30, |
|
|
2008 |
2007 |
2008 |
2007 |
| Revenue |
|
|
|
|
|
Program Fee Revenue |
$ 23,678 |
$
- |
$
1,263 |
$
- |
|
Milestone Revenue |
5,000 |
- |
- |
- |
|
Collaboration Revenue |
7,971 |
- |
2,617 |
- |
|
Total Revenue |
36,649 |
- |
3,880 |
- |
| |
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
Research
and Development |
10,859 |
2,775 |
3,693 |
827 |
|
Marketing, General and Administrative |
5,617 |
1,959 |
3,373 |
593 |
|
Total Operating Expenses |
16,476 |
4,734 |
7,066 |
1,420 |
|
Operating Income (Loss) |
20,173 |
(4,734) |
(3,186) |
(1,420) |
|
|
|
Other
Income (Expense) |
|
|
|
|
|
Interest
Income (Expense), net |
675 |
(1,033) |
171 |
(224) |
|
Amortization of Debt Discount |
- |
(2,700) |
- |
(598) |
|
Loss on
Fair Value Change of Conversion Features |
- |
(3,483) |
- |
- |
|
Loss on
Fair Value Change of Common Stock Warrants |
- |
(1,904) |
- |
(236) |
|
Gain
on Asset Disposals |
1 |
22 |
- |
2 |
|
Other Expense |
- |
(2) |
(17) |
- |
|
Total Other Income (Expense) |
676 |
(9,100) |
154 |
(1,056) |
|
|
|
|
|
|
Income (Loss) Before Income
Tax |
20,849 |
(13,834) |
(3,032) |
(2,476) |
|
Income Tax
Expense (Benefit) |
3,382 |
- |
(6,180) |
- |
|
Net
Income (Loss) |
$ 17,467 |
$
(13,834) |
$
3,148 |
$
(2,476) |
|
|
|
Earnings (Loss) per Share |
|
|
|
|
|
Basic
|
$ 0.38 |
$
(0.37) |
$ 0.07 |
$ (0.06) |
|
Diluted |
$ 0.35 |
$
(0.37) |
$ 0.06 |
$
(0.06) |
| |
|
|
|
|
| Weighted
Average Shares Used in Computation |
|
|
|
|
|
Basic
|
45,670 |
36,998 |
45,680 |
40,155 |
|
Diluted |
49,529 |
36,998 |
49,409 |
40,155 |

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