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
July
14, 2005
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
|
(Commission
File Number)
|
(I.R.S.
Employer
|
|
of
Incorporation)
|
|
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 are 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):
| › |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
| › |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17CFR
240.14a-12)
|
| › |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17CFR240.14d-2(b))
|
| › |
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
July
14, 2005, Acura Pharmaceuticals, Inc. (the "Company") issued a press release
disclosing the financial results for its second quarter ended June 30, 2005.
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 July 14, 2005 Announcing Results for Second
Quarter ended June 30, 2005.
|
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. | ||
| |
|
|
| Date: July 14, 2005 | By: | /s/ Peter A. Clemens |
|
Peter A. Clemens |
||
| Vice President & Chief Financial Officer | ||
EXHIBIT
INDEX
|
Exhibit
Number
|
Description |
| 99.1 |
Press
Release dated July 14, 2005 Announcing Results for Second
Quarter ended June 30, 2005.
|
EXHIBIT
99.1
CONTACT:
Acura
Pharmaceuticals, Inc.
Peter
A.
Clemens, SVP Investor Relations & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. REPORTS FINANCIAL RESULTS
FOR
SECOND QUARTER 2005 and COMMERCIAL STRATEGY/CASH RESERVES
UPDATE
Palatine,
IL, July 14, 2005:
Acura
Pharmaceuticals, Inc. (OTC.BB - ACUR) today announced a net loss of $1.4
million
or $0.06 per share for the quarter ended June 30, 2005 compared to a net
loss of
$17.1 million or $0.79 per share for the same period in 2004. Included in
the
quarter ended June 30, 2004 is a non-cash charge of $13.8 million or $0.64
per
share for amortization of debt discount and private debt offering
costs.
For
the
six months ended June 30, 2005, the Company’s net loss was $3.3 million or $0.15
per share compared to a net loss of $16.4 million or $0.76 per share for
the
same period in 2004. During the six months ended June 30, 2004, the Company
recorded gains of $12.4 million from debt restructuring and $1.8 million
from
the divestment of certain non-revenue generating assets. Expenses for the
six
month period ended June 30, 2004 included, among other things, a non-cash
charge
for amortization of debt discount and private debt offering costs of $24.7
million or $1.14 per share.
Commercial
Strategy/Cash Reserves Update
The
Company plans to enter into development and commercialization agreements
with
strategically focused pharmaceutical company partners (the "Partners") providing
that such Partners license the Company's Aversion™ Technology and further
develop, register and commercialize multiple formulations and strengths of
orally administered opioid containing finished dosage products utilizing
the
Aversion™ Technology. The Company believes it will derive revenues through
licensing fees, milestone payments, profit sharing and/or royalties on net
sales
of such products. To date the Company does not have any such collaborative
agreements. The Company can make no assurance that it will be able to negotiate
such agreements on favorable terms and, even assuming that such agreements
are
successfully executed, that the milestones will be achieved and the milestone
payments will be subsequently made by our Partners. Accordingly, the Company
must rely on its current cash reserves to fund the development of its Aversion™
Technology and related ongoing administrative and operating expenses. The
Company estimates that its current cash reserves will be sufficient through
late
August,
2005 and
that
additional funding will be required. No assurance can be given that the Company
will be successful in obtaining any such additional funding or in securing
licensing agreement fees with Partners on acceptable terms, if at all, or
if
secured, that such financing or licensing agreement fees will provide for
payments to the Company sufficient to fund continuing operations. In the
absence
of such financing or fees from third-party licensing agreements, the Company
will be required to scale back or terminate operations and/or seek protection
under applicable bankruptcy laws.
Acura
Pharmaceuticals, Inc., together with its subsidiaries, is an emerging
pharmaceutical technology development company specializing in proprietary
opioid
abuse deterrent formulation technology. This press release contains forward
looking statements, within the meaning of Section 27A of the Securities Act
of
1933 and Section 21E of the Securities Act of 1934, as amended that are based
on
management's beliefs and assumptions, current expectations, estimates and
projections. Investors are cautioned that forward looking statements involve
risks, uncertainties and other factors, which could cause actual results
to
differ materially from future results expressed or implied by such forward
looking statements. The most significant of such factors include, but are
not
limited to, general economic conditions, competitive conditions, technological
conditions and governmental legislation. More specifically, important factors
that may affect future results include, but are not limited to: changes in
laws
and regulations, particularly those affecting the Company’s operations; the
Company's
ability to continue to attract, assimilate and retain highly skilled
personnel;
its
ability
to secure and protect its patents, trademarks and proprietary rights; litigation
or regulatory action that could require the Company to pay significant damages
or change the way it conducts its business; the Company’s ability to
successfully develop and market its products; customer responsiveness to
new
products and distribution channels; its
ability to compete successfully against current and future
competitors;
its
dependence on third-party suppliers of raw materials; the availability of
controlled substances that constitute the active ingredients of the Company’s
products in development; difficulties or delays in clinical trials for Company
products or in the manufacture of Company products; and other risks and
uncertainties detailed in Company filings with the Securities and Exchange
Commission. The Company is at an early stage of development and may not ever
have any products that generate significant revenue. Further,
the forward looking statements speak only as of the date of such statements
are
made, and the Company undertakes no obligation to update any forward looking
statements to reflect events or circumstances after the date of such statements.
Any or all of the forward looking statements whether included in this release
or
in the Company’s filings with the Securities and Exchange Commission, may turn
out to be wrong. Readers should remember that no forward looking statement
can
be guaranteed and other factors besides those listed above could adversely
affect the Company, its operating results or financial condition.
This
and
past press releases for Acura Pharmaceuticals, Inc. are available at Acura’s web
site at www.acurapharm.com.
ACURA
PHARMACEUTICALS, INC.
FINANCIAL
HIGHLIGHTS
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands)
|
(unaudited)
|
(audited)
|
||||||
|
June
30,
|
December
31,
|
||||||
|
2005
|
2004
|
||||||
|
ASSETS
|
|||||||
|
Current
Assets
|
$
|
1,449
|
$
|
3,410
|
|||
|
Property,
Plant and Equipment, Net
|
1,422
|
1,555
|
|||||
|
Other
Assets
|
7
|
2
|
|||||
|
$
|
2,878
|
$
|
4,967
|
||||
|
LIABILITIES
& STOCKHOLDERS' DEFICIT
|
|||||||
|
Current
Liabilities
|
1,399
|
988
|
|||||
|
Long
Term Debt
|
5,048
|
5,064
|
|||||
|
Stockholders'
Deficit
|
(3,569
|
)
|
(1,085
|
)
|
|||
|
$
|
2,878
|
$
|
4,967
|
||||
ACURA
PHARMACEUTICALS, INC.
FINANCIAL
HIGHLIGHTS
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share data)
|
(unaudited)
|
(unaudited)
|
||||||||||||
|
Six
Months Ended
|
Three
Months Ended
|
||||||||||||
|
June
30,
|
June
30,
|
||||||||||||
|
2005
|
2004
|
2005
|
2004
|
||||||||||
|
Net
Revenues
|
$
|
-
|
$
|
838
|
$
|
-
|
$
|
210
|
|||||
|
Operating
Costs
|
|||||||||||||
|
Cost
of Manufacturing
|
-
|
1,437
|
-
|
184
|
|||||||||
|
Research
and Development
|
1,682
|
1,242
|
729
|
1,004
|
|||||||||
|
Selling,
Marketing, General and Administrative
|
1,492
|
2,363
|
537
|
1,142
|
|||||||||
|
Loss
from Operations
|
(3,174
|
)
|
(4,204
|
)
|
(1,266
|
)
|
(2,120
|
)
|
|||||
|
Other
Income (Expense)
|
|||||||||||||
|
Interest
Expense
|
(263
|
)
|
(2,152
|
)
|
(137
|
)
|
(1,194
|
)
|
|||||
|
Interest
Income
|
24
|
22
|
9
|
15
|
|||||||||
|
Amortization
of Deferred Debt Discount
|
|||||||||||||
|
and
Private Offering Costs
|
-
|
(24,655
|
)
|
-
|
(13,812
|
)
|
|||||||
|
Gain
on Asset Disposals
|
83
|
1,755
|
13
|
1
|
|||||||||
|
Gain
on Debt Restructure
|
-
|
12,401
|
-
|
-
|
|||||||||
|
Other
|
-
|
401
|
(1
|
)
|
(2
|
)
|
|||||||
|
Total
Other Expense
|
(156
|
)
|
(12,228
|
)
|
(116
|
)
|
(14,992
|
)
|
|||||
|
NET
LOSS
|
$
|
(3,330
|
)
|
$
|
(16,432
|
)
|
$
|
(1,382
|
)
|
$
|
(17,112
|
)
|
|
|
Basic
and Diluted Loss Per Share
|
$
|
(0.15
|
)
|
$
|
(0.76
|
)
|
$
|
(0.06
|
)
|
$
|
(0.79
|
)
|
|
|
Weighted
Average Number of Shares Outstanding
|
22,773
|
21,612
|
22,949
|
21,623
|
|||||||||