UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D. C. 20549
____________
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act Of 1934
Date
of
Report (Date of earliest event reported)
___________________________________________________________
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
|
State
of New York
|
1-10113
|
11-0853640
|
|
(State
of Other Jurisdiction
of
Incorporation)
|
(Commission
File Number)
|
(I.R.S.Employer
Identification
Number)
|
616
N. North Court, Suite 120
Palatine,
Illinois 60067
(Address
of principal executive offices) (Zip Code)
(847)
705-7709
(Registrant’s
telephone number, including area code)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
o
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17CFR 240.14a-12)
oPre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17CFR240.14d- 2(b))
o
Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17CFR 240.13e- 4(c))
Item
2.02 Results
of Operations and Financial Condition
On
April
30, 2008, Acura Pharmaceuticals, Inc. (the "Company") issued a press release
disclosing the financial results for its first quarter ended March 31, 2008.
A
copy of the Company's press release is attached as Exhibit 99.1
hereto.
Item
9.01 Financial
Statements and Exhibits
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated April 30, 2008
Announcing Financial Results for the First Quarter of
2008
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
ACURA
PHARMACEUTICALS, INC.
|
||
| |
|
|
| By: | /s/ Peter A. Clemens | |
|
Peter A. Clemens |
||
| Senior Vice President & Chief Financial Officer | ||
Date: April
30,
2008
Exhibit
Index
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated April 30, 2008
Announcing Financial Results for the First Quarter of
2008
|
Acura
Pharmaceuticals
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
Program 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
|
|||||