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)
o
Pre-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
November
2, 2007,
the
Registrant issued a press release disclosing the financial results for its
third
quarter ended September 30, 2007. A copy of the Registrant’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 November 2, 2007 Announcing Financial Results for the
Third
Quarter of 2007
|
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: November
2, 2007
Exhibit
Index
|
Description
|
||
|
99.1
|
Press
Release dated November 2, 2007 Announcing Financial Results for the
Third
Quarter of 2007
|
CONTACT:
Acura
Pharmaceuticals, Inc.
Peter
A.
Clemens, SVP Investor Relations & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. REPORTS
THIRD
QUARTER 2007 FINANCIAL RESULTS
Palatine,
IL, November 2, 2007:
Acura
Pharmaceuticals, Inc. (OTC.BB-ACUR) today announced a net loss of $2.5 million
or $0.01 per share for the quarter ended September 30, 2007 compared to a net
loss of $3.1 million or $0.01 per share for the same period in 2006. Included
in
the 2007 and 2006 quarterly results are non cash compensation expenses of $0.2
million and $0.9 million, respectively, relating to the Company’s issued and
outstanding stock options and restricted stock units. Additionally, the 2007
three month results include non-cash expenses of $0.8 million for losses on
common stock warrants and amortization of debt discount relating to the
Company's bridge loans.
For
the
nine months ended September 30, 2007 the Company had a net loss of $13.8 million
or $0.04 per share compared to a net loss of $9.9 million or $0.03 per share
in
2006. Included in the 2007 and 2006 nine month results are a non cash
compensation expense of $0.9 million and $5.0 million, respectively, primarily
relating to the Company’s issued and outstanding stock options and restricted
stock units. Additionally, the 2007 nine month results include non-cash expenses
of $8.1 million for losses on common stock warrants and fair value changes
in
conversion features, and amortization of debt discount relating to the Company's
bridge loans.
The
Company’s consolidated balance sheets and statements of operations appear below.
Detailed financial statements are included in the Company’s Form 10-Q filed
today with the Securities and Exchange Commission.
Subsequent
Events
On
October 30, 2007, the Company and King Pharmaceuticals Research and Development,
Inc., a subsidiary of King Pharmaceuticals, Inc., entered into a License,
Development and Commercialization Agreement (the "Agreement") for the United
States, Canada, and Mexico (the “Territory”) encompassing a potentially wide
range of opioid analgesic products utilizing Acura’s patented Aversion®
(abuse-deterrent) Technology platform. The Agreement provides King with an
exclusive license in the Territory for ACUROX™ Tablets (formerly OxyADF) and
another undisclosed opioid product utilizing Acura's Aversion® Technology. In
addition, the Agreement provides King with an option to license in the Territory
all future opioid analgesic products developed utilizing Acura's Aversion®
Technology. The closing of the Agreement is subject to clearance under the
Hart-Scott-Rodino Antitrust Improvements Act. Upon the closing of the Agreement,
the Company will pay off its $5 million secured term note. Please refer to
the
Company’s Form 8-K filed with the Securities and Exchange Commission on November
2, 2007 for a further description of the Agreement.
On
October 31, 2007 the Company announced it will effect a 1 for 10 reverse stock
split of the Company’s common stock. The reverse stock split is expected to take
effect on or about December 5, 2007, subject to compliance with OTC Bulletin
Board requirements. Please refer to the Company’s Form 8-K filed with the
Securities and Exchange Commission on October 31, 2007 for a further description
of the reverse stock split.
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 the Company’s expectations and projections. The most significant of such
risks and uncertainties include, but are not limited to, the Company’s ability
to successfully close the transaction executed with King Pharmaceuticals
Research and Development Inc. on October 30, 2007, and enter into additional
contractual arrangements with qualified pharmaceutical partners to license,
develop and commercialize the Company’s technology and product candidates, the
Company’s ability to avoid infringement of patents, trademarks and other
proprietary rights or trade secrets of third parties, and the Company’s ability
to fulfill the FDA’s requirements for approving the Company’s product candidates
for commercial 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 the Company’s
product candidates, the adequacy of the development program for the Company’s
product candidates, changes in regulatory requirements, adverse safety findings
relating to the Company’s product candidates, the risk that the FDA may not
agree with the Company’s 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 the Company’s product candidates are not positive, and
the uncertainties inherent in scientific research, drug development, clinical
trials and the regulatory approval process. You are encouraged to review other
important risk factors relating to the Company on our web site at www.acurapharm.com
under
the link, “Company Risk Factors” and detailed in Company filings with the
Securities and Exchange Commission. The Company is at development stage and
may
never have any products or technologies that generate revenue. Acura
Pharmaceuticals, Inc. assumes no obligation to update any forward-looking
statements as a result of new information or future events or developments.
Acura Pharmaceuticals, Inc. press releases may be reviewed at www.acurapharm.com.
ACURA
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
|
(Unaudited)
September 30,
2007
|
|
(Audited)
December 31,
2006
|
|
||||
|
Current
Assets
|
$
|
13,507
|
$
|
467
|
|||
|
Property,
Plant and Equipment, net
|
1,090
|
1,145
|
|||||
|
Other
Assets
|
7
|
7
|
|||||
|
Total
Assets
|
$
|
14,604
|
$
|
1,619
|
|||
|
Accrued
Expenses
|
412
|
328
|
|||||
|
Deferred
Interest Payable
|
145
|
-
|
|||||
|
Stock
Warrants
|
-
|
10,784
|
|||||
|
Debt,
net
|
5,005
|
28,787
|
|||||
|
Stockholders'
Equity (Deficit)
|
9,042
|
(38,280
|
)
|
||||
|
Total
Liabilities and Stockholders' Equity
|
$
|
14,604
|
$
|
1,619
|
|||
ACURA
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(in
thousands, except per share data)
|
(Unaudited)
Nine
Months Ended
September
30,
|
|
(Unaudited)
Three
Months Ended
September
30,
|
|||||||||||
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|||
|
Operating
Costs
|
|||||||||||||
|
Research
and Development
|
$
|
2,775
|
$
|
4,174
|
$
|
827
|
$
|
1,630
|
|||||
|
Marketing,
General and Administrative
|
1,959
|
4,754
|
593
|
1,031
|
|||||||||
|
Loss
from Operations
|
(4,734
|
)
|
(8,928
|
)
|
(1,420
|
)
|
(2,661
|
)
|
|||||
|
Other
(Expense) Income
|
|||||||||||||
|
Interest
Expense
|
(1,113
|
)
|
(800
|
)
|
(294
|
)
|
(305
|
)
|
|||||
|
Interest
Income
|
80
|
14
|
70
|
4
|
|||||||||
|
Amortization
of Debt Discount
|
(2,700
|
)
|
-
|
(598
|
)
|
-
|
|||||||
|
Loss
on Fair Value Change of Conversion
Features
|
(3,483
|
)
|
-
|
(236
|
)
|
-
|
|||||||
|
Loss
on Fair Value Change of Common
Stock Warrants
|
(1904
|
)
|
-
|
-
|
-
|
||||||||
|
Gain
(Loss) on Asset Disposals
|
22
|
(10
|
)
|
2
|
7
|
||||||||
|
Other
Expense
|
(2
|
)
|
(142
|
)
|
-
|
(142
|
)
|
||||||
|
Total
Other Expense
|
(9,100
|
)
|
(938
|
)
|
(1,056
|
)
|
(436
|
)
|
|||||
|
Net
Loss
|
$
|
(13,834
|
)
|
$
|
(9,866
|
)
|
$
|
(2,476
|
)
|
$
|
(3,097
|
)
|
|
|
Basic
and Diluted Loss Per Common Share Allocable
to Common Stockholders
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
|
|
Weighted
Average Shares Used in Computing Basic and Diluted Loss Per Share
Allocable
to Common Stockholders
|
369,982
|
342,039
|
401,553
|
346,354
|
|||||||||