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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 SECOND QUARTER 2008 FINANCIAL RESULTS
Palatine, IL, July 30, 2008:
Acura Pharmaceuticals, Inc.
(NasdaqCM: ACUR)
today reported 2008 second quarter net
income of $6.9 million, or $0.13 per diluted share compared to a net
loss of $2.2 million, or a $0.06 loss per share for the same quarter in
2007. For the six month period ended June 30, 2008, the Company
reported net income of $14.3 million, or $0.28 per diluted share
compared to a net loss of $11.4 million or a $0.32 loss per share for
2007.
Our
2008 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 six month period ending June 30, 2008, we recognized $32.8 million
in revenues comprised of (i) $22.4 million in Program Fee Revenue
derived from $19.4 million from the amortization of the non-refundable
$30.0 million upfront payment received from King in December, 2007 and
the entire $3.0 million option exercise fee paid by King to us in May
2008 upon exercise of its option to license a third opioid product
candidate; (ii) $5.0 million in Milestone Revenue recognized upon
achievement of the primary endpoints in our pivotal phase III study for
Acurox™ Tablets and (iii) $5.3 million in Collaboration Revenue derived
from reimbursement by King to the Company of Acurox™ Tablets research
and development expenses. The 2008 second quarter results include the
recognition of $8.7 million, $5.0 million and $2.0 million of Program
Fee Revenue, Milestone Revenue, and Collaboration Revenue, respectively.
The Company had no revenues in the same periods in 2007.
The
Company’s research and development expenses increased $5.2 million and
$2.3 million for the six and three months ended June 30, 2008,
respectively as compared with the same periods in 2007. These increases
were primarily attributable to the pivotal Phase III clinical study and
additional clinical testing of the abuse deterrent features of Acurox™
Tablets.
As of July 29, 2008, the
Company had cash and cash equivalents of approximately $37.0 million
with no term indebtedness.
The Company’s condensed
consolidated balance sheets and statements of operations appear below.
Detailed financial statements are included in the Company’s Quarterly
Report on Form 10-Q for the quarter ended June 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.
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 the 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 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 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 10K and our June 30, 2008
SEC form 10Q. 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 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.
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ACURA PHARMACEUTICALS, INC. |
|
CONDENSED CONSOLIDATED
BALANCE SHEETS |
|
(in thousands) |
|
|
|
|
|
|
| |
(Unaudited) |
(Audited) |
| |
June 30, |
December 31, |
|
|
2008 |
2007 |
|
Current
Assets |
$
40,576 |
$
44,582 |
|
Property,
Plant and Equipment, net |
1,123 |
1,046 |
|
Total
Assets |
$
41,699 |
$
45,628 |
|
|
|
|
|
Accrued
Expenses |
597 |
334 |
|
Deferred
Program Fee Revenue |
7,158 |
26,574 |
|
Stockholders' Equity |
33,944 |
18,720 |
|
Total
Liabilities and Stockholders' Equity |
$
41,699 |
$
45,628 |
|
ACURA PHARMACEUTICALS, INC. |
|
CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(in thousands, except per
share data) |
|
|
|
|
(Unaudited)
For the Six Months Ended
June 30, |
(Unaudited)
For the Three Months Ended
June 30, |
|
|
2008 |
2007 |
2008 |
2007 |
|
Revenue |
|
|
|
|
|
Program Fee Revenue |
$ 22,415 |
$
- |
$
8,708 |
$
- |
|
Milestone Revenue |
5,000 |
- |
5,000 |
- |
|
Collaboration Revenue |
5,354 |
- |
1,977 |
- |
|
Total Revenue |
32,769 |
- |
15,685 |
- |
| |
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
Research
and Development |
7,166 |
1,948 |
3,084 |
752 |
|
Marketing, General and Administrative |
2,244 |
1,366 |
1,374 |
588 |
|
Total Operating Expenses |
9,410 |
3,314 |
4,458 |
1,340 |
|
Operating Income (Loss) |
23,359 |
(3,314) |
11,227 |
(1,340) |
|
|
|
Other
Income (Expense) |
|
|
|
|
|
Interest
Income (Expense), net |
504 |
(809) |
207 |
(447) |
|
Amortization of Debt Discount |
- |
(2,102) |
- |
(410) |
|
Loss on
Fair Value Change of Conversion Features |
- |
(3,483) |
- |
- |
|
Loss on
Fair Value Change of Common Stock Warrants |
- |
(1,668) |
- |
- |
|
Other Income (Expense) |
17 |
(2) |
17 |
(2) |
|
Gain
on Asset Disposals |
1 |
20 |
1 |
- |
|
Total Other Income (Expense) |
522 |
(8,044) |
225 |
(859) |
|
|
|
|
|
|
Income (Loss) Before Income
Tax Expense |
23,881 |
(11,358) |
11,452 |
(2,199) |
|
Income Tax
Expense |
9,562 |
- |
4,582 |
- |
|
Net
Income (Loss) |
$ 14,319 |
$
(11,358) |
$
6,870 |
$
(2,199) |
|
|
|
Earnings (Loss) per Share |
|
|
|
|
|
Basic
|
$ 0.31 |
$
(0.32) |
$ 0.15 |
$ (0.06) |
|
Diluted |
$ 0.28 |
$
(0.32) |
$ 0.13 |
$
(0.06) |
| |
|
|
|
|
| Weighted
Average Shares Used in Computation |
|
|
|
|
|
Basic
|
45,665 |
35,404 |
45,673 |
35,540 |
|
Diluted |
51,319 |
35,404 |
51,327 |
35,540 |

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