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
February
21, 2006
Date
of
Report (Date of earliest event reported)
___________________________________________________________
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
|
State
of New
York
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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 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
February 21, 2006, Acura Pharmaceuticals, Inc. (the "Company") issued a press
release disclosing the financial results for its fourth quarter ended December
31, 2005 and the twelve months ended December 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 February 21, 2006 Announcing Results for Fourth
Quarter and Year ended December 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.
| ACURA PHARMACEUTICALS, INC. | ||
| |
|
|
| By: | /s/ Peter A. Clemens | |
|
Peter A. Clemens |
||
| Senior Vice President & Chief Financial Officer | ||
| Date: February 21, 2006 | ||
EXHIBIT
INDEX
|
Exhibit
Number
|
Description
|
| 99.1 |
Press
Release dated February 21, 2006 Announcing Results for Fourth
Quarter and Year ended December 31, 2005.
|
CONTACT:
Acura
Pharmaceuticals, Inc.
Peter
A.
Clemens, SVP Investor Relations & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. REPORTS 2005 FINANCIAL RESULTS,
and
UPDATES OxyADF™ TABLET DEVELOPMENT, COMMERCIAL
STRATEGY
and CASH RESERVES
Palatine,
IL, February 21, 2006:
Acura
Pharmaceuticals, Inc. (OTC.BB-ACUR) today announced a net loss of $7.1 million
or $0.04 per share for the quarter ending December 31, 2005 compared to a net
loss of $2.1 million or $0.09 per share for the same period in 2004. For
calendar year 2005 the Company had a net loss of $12.1 million or $0.18 per
share compared to a net loss of $70.0 million or $3.20 per share in 2004. The
2004 net loss includes a charge of $72.5 million for amortization of debt
discount and private debt offering costs, and a gain of $14.6 million from
debt
restructuring and divestment of non-strategic assets. Highlights of the
Company’s consolidated balance sheet and statements of operation appear below.
Detailed financial statements are included in the Company’s 2005 Form 10-K filed
with the Securities and Exchange Commission.
OxyADF™
Tablets Development Update
The
Company’s lead product candidate, OxyADF™ tablets (formerly referred to by the
Company as Product Candidate #2) is an immediate release tablet under
development pursuant to an active IND on file with the U.S. Food and Drug
Administration (“FDA”). During the first quarter of 2006, as a routine part of
the development process for OxyADF™ tablets, at the Company’s written request,
the Company and the FDA convened a face-to-face End of Phase 2 meeting (“EOP2
Meeting”) for OxyADF tablets. As part of the EOP2 Meeting, the Company and the
FDA discussed, among other things, the laboratory and clinical studies completed
by the Company to date relating to OxyADF™ tablets and the remaining laboratory
and clinical studies anticipated to be completed prior to the submission of
a
505(b)(2) NDA for OxyADF™ tablets. The Company believes the guidance provided by
FDA at the EOP2 Meeting clarifies the remaining development requirements
relating to the Company’s proposed indication and contemplated labeling for
OxyADF™ tablets. The FDA has confirmed in written correspondence to the Company
that OxyADF™ is an appropriate product candidate for submission as a 505(b)(2)
NDA.
To
date
the Company, in concert with its contract research organizations (“CROs”) has
completed one phase I clinical study and one phase II clinical study relating
to
development of OxyADF™ tablets. The results from the phase I clinical study were
used, among other things, to guide the formulation of the OxyADF tablets used
in
the phase II clinical study. Results from the phase II clinical study suggest
that at the anticipated recommended therapeutic doses in normal subjects, OxyADF
tablets will provide a side effects profile similar to the same opioid active
ingredient formulated in a tablet without the Company’s Aversion® Technology.
The Company intends to use the data from such clinical studies in its 505(b)(2)
NDA submission for OxyADF™ tablets.
The
Company, in concert with an independent clinical CRO, has completed a pilot
and
a pivotal bioequivalence study for OxyADF™ tablets. The pivotal bioequivalence
study used tablets from batches manufactured by the Company at a scale of
sufficient size to fulfill the FDA’s requirements for a 505(b)(2) NDA
submission. The final report from the CRO for the pivotal bioequivalence study
confirms that OxyADF™ tablets are bioequivalent to the applicable reference
listed drug. The Company intends to use such data in its 505(b)(2) NDA
submission for OxyADF™ tablets.
In
addition, the Company, in concert with an independent laboratory CRO, completed
a pivotal study to assess certain physical/chemical properties of OxyADF™ using
tablets from batches manufactured by the Company at a scale of sufficient size
to fulfill the FDA’s requirements for a 505(b)(2) NDA submission. The final
report from this pivotal laboratory study confirms that extracting the active
opioid ingredient from OxyADF™ tablets in a form which may be administered via
intravenous injection is substantially more difficult than extracting the active
opioid ingredient from several currently marketed opioid-based commercial
products. The Company intends to utilize the data from this pivotal laboratory
study in its 505(b)(2) NDA submission for OxyADF™.
To
receive marketing authorization for commercial distribution in the United
States, OxyADF™ tablets and any drug product formulated with the Aversion®
Technology will require the development, compilation, submission and filing
of a
NDA and approval of such application by the FDA. Estimating the dates of
completion of laboratory and clinical development, and the costs to complete
development, of the Company's product candidates, including OxyADF™ tablets,
would be highly speculative, subjective and potentially misleading.
Pharmaceutical products require significant time to research, develop and
commercialize. The Company expects to reassess its future research and
development plans based on the review of data received from current research
and
development activities and future guidance from the FDA. The cost and pace
of
future research and development activities are linked and subject to change.
At
this stage there can be no assurance that any of the Company’s research and
development efforts, including those for OxyADF™, will lead to a 505(b)(2) NDA
submission or that if NDA submissions are made with the FDA, that any such
submission will be approved by the FDA.
Commercial
Strategy Update
To
generate revenue, the Company plans to enter into development and
commercialization agreements with strategically focused pharmaceutical company
partners (the "Partners") providing that such Partners license OxyADF™ tablets
and other product candidates utilizing the Aversion® Technology and further
develop, register and commercialize multiple formulations and strengths of
such
product candidates. The Company expects to receive milestone payments and a
share of profits and/or royalty payments derived from the Partners’ sale of
products incorporating the Aversion® Technology. Future revenue, if any, would
be derived from licensing fees, milestone payments and a share of profits and/or
royalty payments relating to our Partners’ sale of products incorporating the
Aversion® Technology. To date, the Company does not have any executed
collaborative agreements with Partners nor can there be any assurance that
the
Company will successfully enter into such collaborative agreements in the
future.
Cash
Reserves Update
As
of
February 1, 2006, the Company had cash and cash equivalents of approximately
$647,000. The Company estimates its current cash reserves will be sufficient
to
fund the development of OxyADF™ tablets and related operating expenses through
mid-to-late March, 2006. To continue operating thereafter, the Company must
raise additional financing or enter into appropriate collaboration agreements
with third parties providing for cash payments to the Company. 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 funding 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.
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc., together with its subsidiary, is a specialty
pharmaceutical company primarily engaged in research, development and
manufacture of innovative abuse deterrent, abuse resistant and tamper resistant
formulations ("Aversion® Technology") intended for use in orally administered
opioid-containing pharmaceutical products.
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 secure additional financing to fund continued product development and
operations, the Company’s ability to enter into 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 challenges inherent in new product development,
including obtaining regulatory approvals. 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.
This
and
past press releases for Acura Pharmaceuticals, Inc. are available at Acura’s web
site at www.acurapharm.com.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|||||||
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(in
thousands)
|
|||||||
|
At
December 31
|
|||||||
|
2005
|
2004
|
||||||
|
Current
Assets
|
$
|
444
|
$
|
3,410
|
|||
|
Property,
Plant and Equipment, Net
|
1,341
|
1,555
|
|||||
|
Other
Assets
|
7
|
2
|
|||||
|
Total
Assets
|
$
|
1,792
|
$
|
4,967
|
|||
|
Current
Liabilities
|
2,922
|
988
|
|||||
|
Long
Term Debt, Net
|
5,032
|
5,064
|
|||||
|
Stockholders'
Deficit
|
(6,162
|
)
|
(1,085
|
)
|
|||
|
Total
Liabilities and Stockholders' Deficit
|
$
|
1,792
|
$
|
4,967
|
|||
|
ACURA
PHARMACEUTICALS, INC.
|
|||||||||||||
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|||||||||||||
|
(in
thousands, except per share data)
|
|||||||||||||
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(unaudited)
|
|||||||||||||
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Three
Months Ended
|
Twelve
Months Ended
|
||||||||||||
|
December
31,
|
December
31,
|
||||||||||||
|
2005
|
2004
|
2005
|
2004
|
||||||||||
|
Net
Product Revenues
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
838
|
|||||
|
Operating
Costs
|
|||||||||||||
|
Cost
of Manufacturing
|
—
|
—
|
—
|
1,435
|
|||||||||
|
Research
and Development
|
3,738
|
951
|
6,265
|
4,130
|
|||||||||
|
Selling,
Marketing, General and Administrative
|
3,176
|
1,000
|
5,296
|
5,238
|
|||||||||
|
Loss
from Operations
|
(6,914
|
)
|
(1,951
|
)
|
(11,561
|
)
|
(9,965
|
)
|
|||||
|
Other
Income (Expense)
|
|||||||||||||
|
Interest
Expense
|
(202
|
)
|
(123
|
)
|
(636
|
)
|
(2,962
|
)
|
|||||
|
Interest
Income
|
6
|
19
|
36
|
59
|
|||||||||
|
Amortization
and Write-off of Debt Discount
|
|||||||||||||
|
and
Deferred Private Debt Offering Costs
|
—
|
—
|
—
|
(72,491
|
)
|
||||||||
|
Gain
on Debt Restructure
|
—
|
—
|
—
|
12,401
|
|||||||||
|
(Loss)
Gain on Asset Disposals
|
(4
|
)
|
(29
|
)
|
81
|
2,359
|
|||||||
|
Other
|
4
|
—
|
5
|
603
|
|||||||||
|
Net
Loss
|
$
|
(7,110
|
)
|
$
|
(2,084
|
)
|
$
|
(12,075
|
)
|
$
|
(69,996
|
)
|
|
|
Basic
and Diluted Loss Per Common Share
|
$
|
(0.04
|
)
|
$
|
(0.09
|
)
|
$
|
(0.18
|
)
|
$
|
(3.20
|
)
|
|
|
Weighted
Average Number of Outstanding Common Shares
|
196,149
|
22,192
|
66,573
|
21,861
|
|||||||||