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

ACURA PHARMACEUTICALS, INC.
REPORTS 2007 4TH QUARTER AND ANNUAL FINANCIAL RESULTS;
SETS 2008 EXPECTATIONS
Palatine, IL, March 05, 2008:
Acura Pharmaceuticals, Inc.
(NASDAQ:ACUR) reported 2007 fourth quarter net income of $9.5 million,
or $0.20 per diluted share compared to net income of $3.9 million, or
$0.44 loss per diluted share (after giving effect to the non-cash deemed
dividend discussed below) for the same quarter in 2006. For the year
ended December 31, 2007, the Company reported a net loss of $4.3
million, or $0.11 per share compared to a net loss of $6.0 million, or
$0.75 per share for 2006. The results for the quarter and year ended
December 31, 2007 include a $9.6 million income tax benefit, or $0.21
per share. The 2007 loss includes non-cash charges of $5.4 million
compared to a gain of $6.4 million in 2006 on fair value changes in
common stock warrants and conversion features relating to the Company's
bridge loans. The net loss per share for the quarter and year ending
December 31, 2006 reflect a non-cash deemed dividend of $20.0 million
and $19.2 million, respectively.
The 2007 results include certain 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. We
classify such revenues as (i) Program Fee Revenue derived from the
non-refundable $30.0 million upfront payment received in December, 2007
and which will be recognized ratably over our estimate of the
development period for each of the product candidates licensed under the
Agreement with King; and (ii) Collaboration Revenue from reimbursement
of research and development expenses. The 2007 results include the
recognition of $3.4 million and $3.0 million of Program Fee Revenue and
Collaboration Revenue, respectively.
As of
March 1, 2008, the Company had cash and cash equivalents of
approximately $31 million with no term indebtedness. The majority of
our cash reserves will be used to develop additional Aversion®
Technology product candidates, prosecute our pending Aversion®
Technology patent applications and for related operating and business
development expenses.
The
Company’s condensed consolidated balance sheet and statements of
operation 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 Annual Report on Form 10-K for the year ended December 31,
2007 filed with the Securities and Exchange Commission.
2007 Accomplishments and 2008 Expectations
Andy
Reddick, President and CEO of Acura said “In 2007 several of the key
strategic initiatives that we have been focused on for several years
resulted in tangible and positive outcomes. We are pleased to report
that the Company is steadily advancing toward our goal of becoming a
leading specialty pharmaceutical company focused on addressing the
growing societal problem of prescription drug abuse. 2007 achievements
included:
 |
April, 2007 – received from the U.S.
Patent and Trademark Office our first issued US Patent encompassing
Aversion® (abuse deterrent) Technology which we believe will provide
patent protection in the U.S. for Aversion® Technology opioid
products at least through the year 2023 |
 |
June, 2007 – reached agreement with the
FDA for a Special Protocol Assessment for the Company’s pivotal
phase III safety and efficacy clinical study for Acurox™ Tablets,
our lead product candidate |
 |
August, 2007 – completed a private
placement of Company securities resulting in elimination of $10.5
million in debt and $14.2 million of new capital to the Company |
 |
September, 2007 – commenced our pivotal
Phase III safety and efficacy study for Acurox™ Tablets |
 |
October, 2007 – signed a major License,
Development and Commercialization Agreement with King resulting in
receipt of a non-refundable $30.0 million payment in December, 2007,
plus reimbursement of Acurox™ Tablet research and development
expenses from September 19, 2007, and expected future milestone
payments and royalties relating to product candidates licensed to
King under the Agreement |
 |
December, 2007 – filed an application
with NASDAQ resulting in the Company’s listing on the NASDAQ Capital
Market effective February 4, 2008 |
In
2008 we will remain focused on execution of our strategy and among other
things expect to:
 |
Submit an IND to the FDA for our second
Aversion® Technology opioid product candidate in the first half of
2008 |
 |
Report top line results for our Acurox™
Tablet pivotal Phase III safety and efficacy study prior to the end
of the third quarter of 2008 |
 |
Submit to the FDA a 505(b)(2) NDA for
Acurox™ Tablets prior to the end of 2008" |
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 or
trade secrets 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) |
|
|
(audited) |
|
|
at December 31 |
|
|
2007 |
2006 |
|
Current
Assets |
$
44,582 |
$
467 |
|
Property,
Plant and Equipment, net |
1,046 |
1,145 |
|
Other
Assets |
- |
7 |
|
Total
Assets |
$
45,628 |
$ 1,619 |
|
|
|
|
|
Accrued
Expenses |
334 |
328 |
|
Stock
Warrants |
- |
10,784 |
|
Debt, net |
- |
28,787 |
|
Stockholders' Equity (Deficit) |
18,720 |
(38,280) |
|
Total
Liabilities and Stockholders' Equity (Deficit) |
$
45,628 |
$ 1,619 |
|
ACURA PHARMACEUTICALS, INC. |
|
CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(in thousands, except per
share data) |
|
|
|
|
(unaudited)
Three Mths Ended Dec 31, |
(audited)
Twelve Mths Ended Dec 31, |
|
|
2007 |
2006 |
2007 |
2006 |
|
Total Revenues |
|
|
|
|
|
Program Fee Revenue |
$
3,427 |
$
- |
$
3,427 |
$
- |
|
Collaboration Revenue |
2,977 |
- |
2,977 |
- |
|
Total Revenues |
6,404 |
- |
6,404 |
- |
| |
|
|
|
|
|
Operating Costs |
|
|
|
|
|
Research
and Development |
4,394 |
997 |
7,169 |
5,172 |
|
Marketing, General and Administrative |
2,182 |
900 |
4,141 |
5,654 |
|
Total Operating Expenses |
6,576 |
1,897 |
11,310 |
10,826 |
|
Loss
from Operations |
(172) |
(1,897) |
(4,906) |
(10,826) |
|
|
|
Other
Income (Expense) |
|
|
|
|
|
Interest
Income |
188 |
4 |
268 |
18 |
|
Interest
Expense |
(94) |
(340) |
(1,207) |
(1,140) |
|
Amortization of Debt Discount |
- |
(183) |
(2,700) |
(183) |
|
Gain
(Loss) on
Fair Value Change of Conversion Features |
- |
4,235 |
(3,483) |
4,235 |
|
Gain
(Loss) on
Fair Value Change of Common Stock Warrants |
- |
2,164 |
(1,905) |
2,164 |
|
Gain
(Loss) on Asset Disposals |
- |
(71) |
22 |
(22) |
|
Other
Expense |
(1) |
(12) |
(3) |
(213) |
|
Total Other Income (Expense) |
93 |
5,797 |
(9,008) |
4,859 |
|
Income (Loss) Before Income
Tax Benefit |
(79) |
3,900 |
(13,914) |
(5,967) |
|
Income Tax Benefit |
( 9,600) |
- |
(9,600) |
- |
|
Net
Income (Loss) |
$ 9,521 |
$
3,900 |
$
(4,314) |
$ (5,967) |
|
|
|
Income (Loss) Per Common
Share Applicable to Common Shareholders |
|
|
|
|
|
Basic
|
$ 0.21 |
$ (0.44) |
$
(0.11) |
$ (0.75) |
|
Diluted |
$ 0.20 |
$ (0.44) |
$
(0.11) |
$ (0.75) |
| |
|
|
|
|
|
Weighted
Average Number of Outstanding Common Shares |
45,488 |
34,864 |
39,157 |
34,496 |

Any questions or comments
regarding Press Releases should be directed to our department of
Investor Relations.
Return to the
Press Release Archive |
|
| |