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
|
(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
October
27, 2008,
the
Registrant issued a press release disclosing the financial results for its
third
quarter ended September 30, 2008. A copy of the Registrant’s press release is
furnished as Exhibit 99.1 hereto.
Item
9.01 Financial
Statements and Exhibits
Exhibit
Number
Description
99.1 Press
Release dated October
27, 2008
Announcing Financial Results for the Third Quarter of 2008
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: October
27, 2008
Exhibit
Index
Exhibit
Number
Description
99.1
Press
Release dated October
27, 2008
Announcing Financial Results for the Third Quarter of
2008
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. REPORTS
THIRD
QUARTER 2008 FINANCIAL RESULTS
Palatine,
IL, October 27, 2008: Acura
Pharmaceuticals, Inc. (Nasdaq: ACUR) today reported 2008 third quarter net
income of $3.1 million, or $0.06 per diluted share compared to a net loss
of
$2.5 million, or a ($0.06) loss per share for the same quarter in 2007. For
the
nine months ending September 30, 2008, the Company reported net income of
$17.5
million, or $0.35 per diluted share compared to a net loss of $13.8 million
or a
($0.37) loss per share for the same period in 2007. As of October 24, 2008,
we
had cash and cash equivalents of approximately $35.0 million with no term
indebtedness.
Our
financial results include 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. For the nine months ending September
30, 2008, we recognized $36.6 million in revenues resulting from the Agreement
comprised of (i) $23.7 million in Program Fee Revenue including our amortization
of $20.7 million of the non-refundable upfront payment received from King
in
December, 2007 and the $3.0 million fee received upon King's exercise of
its
option to license a third opioid analgesic product candidate utilizing Aversion®
(abuse deterrent) Technology; (ii) $5.0 million in Milestone Revenue recognized
upon successful achievement of the primary pain relief endpoints in our Acurox™
(oxycodone HCl/niacin) Tablets pivotal phase III clinical study and (iii)
$8.0
million in Collaboration Revenue from King's reimbursement of our research
and
development expenses related to product candidates licensed to King. The
2008
third quarter results include the recognition of $1.2 million and $2.6 million
of Program Fee Revenue and Collaboration Revenue, respectively. We had no
revenues in the same period in 2007.
Our
research and development expenses increased $8.1 million and $2.9 million
for
the nine and three months ended September 30, 2008, respectively, compared
with
the same periods in 2007. These increases were primarily attributable to
the
pivotal Phase III clinical study and Phase I and II clinical studies assessing
the abuse deterrent features of Acurox™ Tablets. In the nine and three months
results for 2008, a $5.0 million tax benefit was recorded to reflect the
expected future utilization of prior years net operating losses which will
reduce future taxes payable.
Our
condensed consolidated balance sheets and statements of operations appear
below.
Detailed financial statements are included in our Quarterly Report on Form
10-Q
for the quarter ended September 30, 2008 filed with the Securities and Exchange
Commission.
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.
About
Forward Looking Statements
Certain
statements in this press release constitute "forward-looking statements"
within
the meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve known and unknown risks, uncertainties
and
other factors which may cause our actual results, performance or achievements
to
be materially different from any future results, performance, or achievements
expressed or implied by such forward-looking statements. The most significant
of
such factors include, but are not limited to, our ability, the ability of
King
Pharmaceuticals (to whom we have licensed our Aversion® Technology for certain
opioid analgesic products in the United States, Canada and Mexico) and the
ability of other pharmaceutical companies, if any, to whom we may license
our
Aversion® Technology, to obtain necessary regulatory approvals and commercialize
products utilizing Aversion® Technology, the ability to avoid infringement of
patents, trademarks and other proprietary rights of third parties, and the
ability to fulfill the U.S. Food and Drug Administration’s (“FDA”) 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 laboratory and clinical studies completed to date and
the
results of other laboratory and 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 unpredictability of the duration and results
of
FDA review of filings made with the FDA relating to our product candidates,
the
risk that the FDA may not agree with our analysis of our 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 or otherwise do not support FDA approval or commercially viable
product
labeling, and the uncertainties inherent in scientific research, drug
development, clinical trials and the regulatory approval process. Other
important factors that may also affect future results include, but are not
limited to: our ability to attract and retain highly skilled personnel; our
ability to timely submit the New Drug Application for Acurox with the FDA;
our
ability to secure and protect our patents, trademarks and proprietary rights;
litigation or regulatory action that could require us to pay significant
damages
or change the way we conduct our business; our ability to compete successfully
against current and future competitors; our dependence on third-party suppliers
of raw materials; our ability to secure U.S. Drug Enforcement Administration
("DEA") quotas and source the active ingredients of our products in development;
difficulties or delays in clinical trials for our product candidate or in
the
commercial manufacture and supply of our products; and other risks and
uncertainties detailed in our 2007 SEC Form 10-K and our September 30, 2008
SEC
Form 10-Q. When used in this press release, the words "estimate," "project,"
"anticipate," "expect," "intend," "believe," and similar expressions are
intended to identify forward-looking statements. You are encouraged to review
other important risk factors 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.
|
ACURA
PHARMACEUTICALS, INC.
|
|||||||
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|||||||
|
(in
thousands)
|
|||||||
|
(Unaudited)
|
(Audited)
|
||||||
|
September
30,
|
December
31,
|
||||||
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2008
|
2007
|
||||||
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Current
Assets
|
$
|
42,051
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$
|
44,582
|
|||
|
Deferred
Income Taxes
|
3,400
|
-
|
|||||
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Property,
Plant and Equipment, net
|
1,102
|
1,046
|
|||||
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Total
Assets
|
$
|
46,553
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$
|
45,628
|
|||
|
Accrued
Expenses
|
2,084
|
334
|
|||||
|
Deferred
Program Fee Revenue
|
5,895
|
26,574
|
|||||
|
Stockholders'
Equity
|
38,574
|
18,720
|
|||||
|
Total
Liabilities and Stockholders' Equity
|
$
|
46,553
|
$
|
45,628
|
|||
|
ACURA
PHARMACEUTICALS, INC.
|
|||||||||||||
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|||||||||||||
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(in
thousands, except per share data)
|
|||||||||||||
|
(Unaudited)
For
the Nine Months
Ended
September 30,
|
(Unaudited)
For
the Three Months
Ended
September 30,
|
||||||||||||
|
2008
|
2007
|
2008
|
2007
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||||||||||
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Revenue
|
|||||||||||||
|
Program
Fee Revenue
|
$
|
23,678
|
$
|
-
|
$
|
1,263
|
$
|
-
|
|||||
|
Milestone
Revenue
|
5,000
|
-
|
-
|
-
|
|||||||||
|
Collaboration
Revenue
|
7,971
|
-
|
2,617
|
-
|
|||||||||
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Total
Revenue
|
36,649
|
-
|
3,880
|
-
|
|||||||||
|
Operating
Expenses
|
|||||||||||||
|
Research
and Development Expenses
|
10,859
|
2,775
|
3,693
|
827
|
|||||||||
|
Marketing,
General and Administrative Expenses
|
5,617
|
1,959
|
3,373
|
593
|
|||||||||
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Total
Operating Expenses
|
16,476
|
4,734
|
7,066
|
1,420
|
|||||||||
|
Operating
Income (Loss)
|
20,173
|
(4,734
|
)
|
(3,186
|
)
|
(1420
|
)
|
||||||
|
|
|||||||||||||
|
Other
Income (Expense)
|
|||||||||||||
|
Interest
Income (Expense), net
|
675
|
(1,033
|
)
|
171
|
(224
|
)
|
|||||||
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Amortization
of Debt Discount
|
-
|
(2,700
|
)
|
-
|
(598
|
)
|
|||||||
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Loss
on Fair Value Change of Conversion Features
|
-
|
(3,483
|
)
|
-
|
-
|
||||||||
|
Loss
on Fair Value Change of Common Stock Warrants
|
-
|
(1,904
|
)
|
-
|
(236
|
)
|
|||||||
|
Gain
on Asset Disposals
|
1
|
22
|
-
|
2
|
|||||||||
|
Other
Expense
|
-
|
(2
|
)
|
(17
|
)
|
-
|
|||||||
|
Total
Other Income (Expense)
|
676
|
(9,100
|
)
|
154
|
(1,056
|
)
|
|||||||
|
Income
(Loss) before Income Tax
|
20,849
|
(13,834
|
)
|
(3,032
|
)
|
(2,476
|
)
|
||||||
|
Income
Tax Expense (benefit)
|
3,382
|
-
|
(6,180
|
)
|
-
|
||||||||
|
Net
Income (Loss)
|
$
|
17,467
|
$
|
(13,834
|
)
|
$
|
3,148
|
$
|
(2,476
|
)
|
|||
|
Earnings
(Loss) per Share
|
|||||||||||||
|
Basic
|
$
|
0.38
|
$
|
(0.37
|
)
|
$
|
0.07
|
$
|
(0.06
|
)
|
|||
|
Diluted
|
$
|
0.35
|
$
|
(0.37
|
)
|
$
|
0.06
|
$
|
(0.06
|
)
|
|||
|
Weighted
Average Shares Used in Computation
|
|||||||||||||
|
Basic
|
45,670
|
36,998
|
45,680
|
40,155
|
|||||||||
|
Diluted
|
49,529
|
36,998
|
49,409
|
40,155
|
|||||||||