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
March
5, 2008
Date
of
Report (Date of earliest event reported)
___________________________________________________________
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
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State
of New York
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1-10113
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11-0853640
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(State
of Other Jurisdiction
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(Commission
File Number)
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(I.R.S.
Employer
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|
of
Incorporation)
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Identification
Number)
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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):
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17CFR240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17CFR
240.13e-4(c))
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Item
2.02
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Results
of Operations and Financial
Condition
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On
March
5, 2008, Acura Pharmaceuticals, Inc. (the "Company") issued a press release
disclosing the financial results for its fourth quarter ended December 31,
2007
and the twelve months ended December 31, 2007. A copy of the Company's press
release is furnished as Exhibit 99.1 hereto.
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Item
9.01
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Financial
Statements and
Exhibits
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Exhibit
Number
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Description
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99.1
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Press
Release dated March 5, 2008Announcing Results for Fourth Quarter and
Year Ended December 31,
2007
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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. | ||
| |
|
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| By: | /s/ Peter A. Clemens | |
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Peter A. Clemens |
||
| Senior Vice President & Chief Financial Officer | ||
Date: March
5,
2008
Exhibit
Index
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Exhibit
Number
|
Description
|
|
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99.1
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Press
Release dated March 5, 2008Announcing Results for Fourth Quarter and
Year Ended December 31, 2007
|
CONTACT:
Acura
Pharmaceuticals, Inc.
Peter
A.
Clemens, SVP Investor Relations & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. REPORTS 2007 4th
QUARTER AND ANNUAL
FINANCIAL
RESULTS; SETS 2008 EXPECTATIONS
Palatine,
IL, March 5, 2008: Acura
Pharmaceuticals, Inc. (NASDAQ:ACUR) reported 2007 fourth quarter net income
of
$9.5 million, or $0.20 per diluted share compared to net income of $3.9 million,
or $0.44 loss per diluted share (after giving effect to the non-cash deemed
dividend discussed below) for the same quarter in 2006. For the year ended
December 31, 2007, the Company reported a net loss of $4.3 million, or $0.11
per
share compared to a net loss of $6.0 million, or $0.75 per share for 2006.
The
results for the quarter and year ended December 31, 2007 include a $9.6 million
income tax benefit, or $0.21 per share. The 2007 loss includes non-cash charges
of $5.4 million compared to a gain of $6.4 million in 2006 on fair value changes
in common stock warrants and conversion features relating to the Company's
bridge loans. The net loss per share for the quarter and year ending December
31, 2006 reflect a non-cash deemed dividend of $20.0 million and $19.2 million,
respectively.
The
2007
results include certain 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. We classify such revenues as (i)
Program Fee Revenue derived from the non-refundable $30.0 million upfront
payment received in December, 2007 and which will be recognized ratably over
our
estimate of the development period for each of the product candidates licensed
under the Agreement with King; and (ii) Collaboration Revenue from reimbursement
of research and development expenses. The 2007 results include the recognition
of $3.4 million and $3.0 million of Program Fee Revenue and Collaboration
Revenue, respectively.
As
of
March 1, 2008, the Company had cash and cash equivalents of approximately $31
million with no term indebtedness. The majority of our cash reserves will be
used to develop additional Aversion® Technology product candidates, prosecute
our pending Aversion® Technology patent applications and for related operating
and business development expenses.
The
Company’s condensed consolidated balance sheet and statements of operation
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 Annual Report on Form 10-K
for the year ended December 31, 2007 filed with the Securities and Exchange
Commission.
2007
Accomplishments and 2008 Expectations
Andy
Reddick, President and CEO of Acura said “In 2007 several of the key strategic
initiatives that we have been focused on for several years resulted in tangible
and positive outcomes. We are pleased to report that the Company is steadily
advancing toward our goal of becoming a leading specialty pharmaceutical company
focused on addressing the growing societal problem of prescription drug abuse.
2007 achievements included:
|
·
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April,
2007 - received from the U.S. Patent and Trademark Office our first
issued
US Patent encompassing Aversion® (abuse deterrent) Technology which we
believe will provide patent protection in the U.S. for Aversion®
Technology opioid products at least through the year
2023
|
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·
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June,
2007 - reached agreement with the FDA for a Special Protocol Assessment
for the Company’s pivotal phase III safety and efficacy clinical study for
Acurox™ Tablets, our lead product
candidate
|
|
·
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August,
2007 - completed a private placement of Company securities resulting
in
elimination of $10.5 million in debt and $14.2 million of new capital
to
the Company
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|
·
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September,
2007 - commenced our pivotal Phase III safety and efficacy study
for
Acurox™ Tablets
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|
·
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October,
2007 - signed a major License, Development and Commercialization
Agreement
with King resulting in receipt of a non-refundable $30.0 million
payment
in December, 2007, plus reimbursement of Acurox™ Tablet research and
development expenses from September 19, 2007, and expected future
milestone payments and royalties relating to product candidates licensed
to King under the Agreement
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·
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December,
2007 - filed an application with NASDAQ resulting in the Company’s listing
on the NASDAQ Capital Market effective February 4,
2008
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In
2008
we will remain focused on execution of our strategy and among other things
expect to:
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·
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Submit
an IND to the FDA for our second Aversion® Technology opioid product
candidate in the first half of 2008
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·
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Report
top line results for our Acurox™ Tablet pivotal Phase III safety and
efficacy study prior to the end of the third quarter of
2008
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·
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Submit
to the FDA a 505(b)(2) NDA for Acurox™ Tablets prior to the end of 2008"
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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 or trade secrets 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.
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ACURA
PHARMACEUTICALS, INC.
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|||||||
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CONDENSED
CONSOLIDATED BALANCE SHEETS
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|||||||
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(in
thousands)
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|||||||
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(audited)
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|||||||
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at
December 31,
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|||||||
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2007
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2006
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||||
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Current
Assets
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$
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44,582
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$
|
467
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|||
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Property,
Plant and Equipment, net
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1,046
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1,145
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|||||
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Other
Assets
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-
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7
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|||||
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Total
Assets
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$
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45,628
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$
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1,619
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|||
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Accrued
Expenses
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334
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328
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|||||
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Stock
Warrants
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-
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10,784
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|||||
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Debt,
net
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-
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28,787
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|||||
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Stockholders'
Equity (Deficit)
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18,720
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(38,280
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)
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||||
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Total
Liabilities and Stockholders' Deficit
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$
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45,628
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$
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1,619
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|||
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ACURA
PHARMACEUTICALS, INC.
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|||||||||||||
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CONSOLIDATED
STATEMENTS OF OPERATIONS
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|||||||||||||
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(in
thousands, except per share data)
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|||||||||||||
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(unaudited)
Three
Mths Ended Dec 31,
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(audited)
Twelve
Mths Ended Dec 31,
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||||||||||||
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2007
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|
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2006
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|
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2007
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2006
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||||
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Total
Revenues
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|||||||||||||
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Program
Fee Revenue
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$
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3,427
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$
|
-
|
$
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3,427
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$
|
-
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|||||
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Collaboration
Revenue
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2,977
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-
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2,977
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-
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|||||||||
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Total
Revenues
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6,404
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-
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6,404
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-
|
|||||||||
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Operating
Costs
|
|||||||||||||
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Research
and Development
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4,394
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997
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7,169
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5,172
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|||||||||
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Marketing,
General and Administrative
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2,182
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900
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4,141
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5,654
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|||||||||
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Total
Operating Expenses
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6,576
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1,897
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11,310
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10,826
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|||||||||
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Loss
from Operations
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(172
|
)
|
(1,897
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)
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(4,906
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)
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(10,826
|
)
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|||||
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Other
Income (Expense)
|
|||||||||||||
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Interest
Income
|
188
|
4
|
268
|
18
|
|||||||||
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Interest
Expense
|
(94
|
)
|
(340
|
)
|
(1,207
|
)
|
(1,140
|
)
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|||||
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Amortization
of Debt Discount
|
-
|
(183
|
)
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(2,700
|
)
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(183
|
)
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||||||
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Gain
(Loss) on Fair Value Change of
Conversion
Features
|
-
|
4,235
|
(3,483
|
)
|
4,235
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||||||||
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Gain
(Loss) on Fair Value Change of
Common
Stock Warrants
|
-
|
2,164
|
(1,905
|
)
|
2,164
|
||||||||
|
Gain
(Loss) on Asset Disposals
|
-
|
(71
|
)
|
22
|
(22
|
)
|
|||||||
|
Other
Expense
|
(1
|
)
|
(12
|
)
|
(3
|
)
|
(213
|
)
|
|||||
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Total
Other Income (Expense)
|
93
|
5,797
|
(9,008
|
)
|
4,859
|
||||||||
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Income
(Loss) Before Income Tax Benefit
|
(79
|
)
|
3,900
|
(13,914
|
)
|
(5,967
|
)
|
||||||
|
Income
Tax Benefit
|
(9,600
|
)
|
-
|
(9,600
|
)
|
-
|
|||||||
|
Net
Income (Loss)
|
$
|
9,521
|
$
|
3,900
|
$
|
(4,314
|
)
|
$
|
(5,967
|
)
|
|||
|
Income
(Loss) Per Common Share
Applicable
to Common Stockholders
|
|||||||||||||
|
Basic
|
$
|
0.21
|
$
|
(0.44
|
)
|
$
|
(0.11
|
)
|
$
|
(0.75
|
)
|
||
|
Diluted
|
$
|
0.20
|
$
|
(0.44
|
)
|
$
|
(0.11
|
)
|
$
|
(0.75
|
)
|
||
|
Weighted
Average Number of
Outstanding
Common Shares
|
45,488
|
34,864
|
39,157
|
34,496
|
|||||||||