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
May
2, 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 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 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):
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 May 2,
2005, Acura Pharmaceuticals, Inc. (the "Company") issued a press release
disclosing the financial results for its first quarter ended March 31, 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 May 2, 2005 Announcing Results for First Quarter ended March
31, 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.
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ACURA
PHARMACEUTICALS, INC. |
|
|
|
|
By: |
/s/ Peter A. Clemens |
|
Peter A. Clemens |
|
Vice President & Chief
Financial Officer |
Date: May 2,
2005
EXHIBIT
INDEX
Exhibit |
|
Number |
Description |
|
|
99.1 |
Press
|
EXHIBIT
99.1
CONTACT:
Acura
Pharmaceuticals, Inc.
Investor
Relations, Peter A. Clemens, SVP & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. REPORTS RESULTS FOR FIRST QUARTER
2005
Palatine,
IL, May 2, 2005: Acura
Pharmaceuticals, Inc. (OTC.BB-ACUR) today announced net loss of $1,948,000 for
the quarter ended March 31, 2005 compared to a net income of $680,000 for the
same period in 2004. During the first quarter of 2005 the Company was focused
primarily on research and development activities associated with the Company’s
proprietary Aversion™ Technology and had no product sales revenues. In the same
period of 2004 the Company had product sales revenues of $628,000 associated
with the phase out of its generic product manufacturing and distribution
activities. Also in the first quarter of 2004 the Company recorded gains of
$12,401,000 from debt restructuring, $1,754,000 from the divestment of certain
non-revenue generating assets and amortization of debt discount and private
offering costs of $10,843,000. Loss per share for the first quarter of 2005 was
$0.09, compared to basic and diluted earnings per share of $ 0.03 and $0.00
respectively, for the same period in 2004.
Commenting,
Andy Reddick, said, “We are focusing our resources on developing the Company’s
proprietary opioid abuse deterrent formulation technology. We envision that
orally administered opioid containing tablets or capsules formulated with the
Aversion™ Technology will discourage or deter pre-existing opioid drug abusers
or legitimate patients properly using opioid containing analgesics from abusing
such products. With the clearance of our IND for Product Candidate #2 the
Company hopes to continue moving its clinical development program forward and
demonstrate the commercial value of products incorporating our Aversion™
Technology.”
Commercial
Strategy 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 that it will derive revenues through
licensing fees, milestone payments, profit sharing and/or royalties on net sales
of such products and from the contract manufacture and supply of clinical trial
and commercial supplies of finished dosage products for distribution and sale by
such Partners. 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.
Cash
Reserves Update
The
Company estimates that its current cash reserves will be sufficient to fund the
development of the Aversion™ Technology and related operating expenses through
June,
2005. To
fund operations through June 2006, the Company estimates that it must raise
additional financing, or enter into collaboration agreements with third parties
providing for net proceeds to the Company of approximately $6 million. No
assurance can be given that the Company will be successful in obtaining any such
financing or in securing collaborative agreements with third parties on
acceptable terms, if at all, or if secured, that such financing or collaborative
agreements will provide for payments to the Company sufficient to continue to
fund operations. In the absence of such financing or third-party
collaborative 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. |
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FINANCIAL
HIGHLIGHTS |
|
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CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
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(In
thousands, except earnings per share data) |
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(unaudited) |
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Three
Months Ended |
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March
31, |
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|
2005 |
|
2004 |
|
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Net
Revenues |
|
$ |
- |
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$ |
628 |
|
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Operating
Costs |
|
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Cost
of Manufacturing |
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|
-
|
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1,253
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Research
and Development |
|
|
953
|
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238
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Selling,
Marketing, General and Administrative |
|
|
955
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1,221
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Loss
from Operations |
|
|
(1,908 |
) |
|
(2,084 |
) |
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Other
(Expense) Income |
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Interest
Expense |
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|
(126 |
) |
|
(958 |
) |
Interest
Income |
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|
15
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7
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|
Amortization
of Deferred Debt Discount |
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and
Private Offering Costs |
|
|
-
|
|
|
(10,843 |
) |
Gain
on Asset Disposals |
|
|
70
|
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|
1,754
|
|
Gain
on Debt Restructure |
|
|
-
|
|
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12,401
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Other
|
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|
1
|
|
|
403
|
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NET
(LOSS) INCOME |
|
$ |
(1,948 |
) |
$ |
680 |
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(Loss)
Earnings Per Share |
|
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Basic |
|
$ |
(0.09 |
) |
$ |
0.03 |
|
Diluted |
|
$ |
(0.09 |
) |
$ |
0.00 |
|
|
|
|
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Weighted
Average of Shares Outstanding |
|
|
|
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Basic |
|
|
22,336
|
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|
21,602
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Diluted |
|
|
22,336
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|
278,020
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ACURA
PHARMACEUTICALS, INC. |
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FINANCIAL
HIGHLIGHTS |
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|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
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(In
thousands) |
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|
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(unaudited) |
|
(audited) |
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March
31, |
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December
31, |
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2005 |
|
2004 |
|
ASSETS |
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Current
Assets |
|
$ |
2,172 |
|
$ |
3,410 |
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Property,
Plant and Equipment, Net |
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|
1,428
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|
1,555
|
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|
|
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Other
Assets |
|
|
2
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,602 |
|
$ |
4,967 |
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LIABILITIES
& STOCKHOLDERS' DEFICIT |
|
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Current
Liabilities |
|
|
1,093
|
|
|
988
|
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|
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|
|
|
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Long
Term Debt |
|
|
5,057
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|
5,064
|
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|
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|
|
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Stockholders'
Deficit |
|
|
(2,548 |
) |
|
(1,085 |
) |
|
|
|
|
|
|
|
|
|
|
$ |
3,602 |
|
$ |
4,967 |
|