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
July
30, 2008 we issued a press release disclosing the financial results for our
second quarter ended June 30, 2008. A copy of our press release is being
furnished as Exhibit 99.1 hereto.
Item
9.01 Financial
Statements and Exhibits
|
Exhibit Number
|
Description
|
|
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99.1
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Press
Release dated July 30, 2008 Announcing Financial Results for the
Second
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: July
30,
2008
Exhibit
Index
|
Exhibit Number
|
Description
|
|
|
99.1
|
Press
Release dated July 30, 2008 Announcing Financial Results for the
Second
Quarter of 2008
|
 |
Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
847-705-7709
|
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. REPORTS
SECOND
QUARTER 2008 FINANCIAL RESULTS
Palatine,
IL, July 30, 2008:
Acura
Pharmaceuticals, Inc. (NasdaqCM: ACUR) today reported 2008 second quarter net
income of $6.9 million, or $0.13 per diluted share compared to a net loss of
$2.2 million, or a $0.06 loss per share for the same quarter in 2007. For the
six month period ended June 30, 2008, the Company reported net income of $14.3
million, or $0.28 per diluted share compared to a net loss of $11.4 million
or a
$0.32 loss per share for 2007.
Our
2008
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 six month period ending June
30, 2008, we recognized $32.8 million in revenues comprised of (i) $22.4 million
in Program Fee Revenue derived from $19.4 million from the amortization of
the
non-refundable $30.0 million upfront payment received from King in December,
2007 and the entire $3.0 million option exercise fee paid by King to us in
May
2008 upon exercise of its option to license a third opioid product candidate;
(ii) $5.0 million in Milestone Revenue recognized upon achievement of the
primary endpoints in our pivotal phase III study for Acurox™ Tablets and (iii)
$5.3 million in Collaboration Revenue derived from reimbursement by King to
the
Company of Acurox™ Tablets research and development expenses. The 2008 second
quarter results include the recognition of $8.7 million, $5.0 million and $2.0
million of Program Fee Revenue, Milestone Revenue, and Collaboration Revenue,
respectively. The Company had no revenues in the same periods in
2007.
The
Company’s research and development expenses increased $5.2 million and $2.3
million for the six and three months ended June 30, 2008, respectively as
compared with the same periods in 2007. These increases were primarily
attributable to the pivotal Phase III clinical study and additional clinical
testing of the abuse deterrent features of Acurox™ Tablets.
As
of
July 29, 2008, the Company had cash and cash equivalents of approximately $37.0
million with no term indebtedness.
The
Company’s condensed consolidated balance sheets and statements of operations
appear below. Detailed financial statements are included in the Company’s
Quarterly Report on Form 10-Q for the quarter ended June 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.
1
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 the 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 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 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 10K and our
June
30, 2008 SEC form 10Q. 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 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.
2
ACURA
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
|
(Unaudited)
|
(Audited)
|
||||||
|
June
30,
|
December
31,
|
||||||
|
2008
|
2007
|
||||||
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Current
Assets
|
$
|
40,576
|
$
|
44,582
|
|||
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Property,
Plant and Equipment, net
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1,123
|
1,046
|
|||||
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Total
Assets
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$
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41,699
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$
|
45,628
|
|||
|
Accrued
Expenses
|
597
|
334
|
|||||
|
Deferred
Program Fee Revenue
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7,158
|
26,574
|
|||||
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Stockholders'
Equity
|
33,944
|
18,720
|
|||||
|
Total
Liabilities and Stockholders' Equity
|
$
|
41,699
|
$
|
45,628
|
|||
3
ACURA
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(in
thousands, except per share data)
|
|
(Unaudited)
For
the Six Months
Ended
June 30,
|
|
(Unaudited)
For
the Three Months
Ended
June 30,
|
|
|||||||||
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
||||
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Revenue
|
|||||||||||||
|
Program
Fee Revenue
|
$
|
22,415
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$
|
-
|
$
|
8,708
|
$
|
-
|
|||||
|
Milestone
Revenue
|
5,000
|
-
|
5,000
|
-
|
|||||||||
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Collaboration
Revenue
|
5,354
|
-
|
1,977
|
-
|
|||||||||
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Total
Revenue
|
32,769
|
-
|
15,685
|
-
|
|||||||||
|
Operating
Expenses
|
|||||||||||||
|
Research
and Development Expenses
|
7,166
|
1,948
|
3,084
|
752
|
|||||||||
|
Marketing,
General and Administrative Expenses
|
2,244
|
1,366
|
1,374
|
588
|
|||||||||
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Total
Operating Expenses
|
9,410
|
3,314
|
4,458
|
1,340
|
|||||||||
|
Operating
Income (Loss)
|
23,359
|
(3,314
|
)
|
11,227
|
(1,340
|
)
|
|||||||
|
|
|||||||||||||
|
Other
Income (Expense)
|
|||||||||||||
|
Interest
Income (Expense), net
|
504
|
(809
|
)
|
207
|
(447
|
)
|
|||||||
|
Amortization
of Debt Discount
|
-
|
(2,102
|
)
|
-
|
(410
|
)
|
|||||||
|
Loss
on Fair Value Change of Conversion Features
|
-
|
(3,483
|
)
|
-
|
-
|
||||||||
|
Loss
on Fair Value Change of Common Stock Warrants
|
-
|
(1,668
|
)
|
-
|
-
|
||||||||
|
Other
Income (Expense)
|
17
|
(2
|
)
|
17
|
(2
|
)
|
|||||||
|
Gain
on Asset Disposals
|
1
|
20
|
1
|
-
|
|||||||||
|
Total
Other Income (Expense)
|
522
|
(8,044
|
)
|
225
|
(859
|
)
|
|||||||
|
Income
(Loss) before Income Tax Expense
|
23,881
|
(11,358
|
)
|
11,452
|
(2,199
|
)
|
|||||||
|
Income
Tax Expense
|
9,562
|
-
|
4,582
|
-
|
|||||||||
|
Net
Income (Loss)
|
$
|
14,319
|
$
|
(11,358
|
)
|
$
|
6,870
|
$
|
(2,199
|
)
|
|||
|
Earnings
(Loss) per Share
|
|||||||||||||
|
Basic
|
$
|
0.31
|
$
|
(0.32
|
)
|
$
|
0.15
|
$
|
(0.06
|
)
|
|||
|
Diluted
|
$
|
0.28
|
$
|
(0.32
|
)
|
$
|
0.13
|
$
|
(0.06
|
)
|
|||
|
Weighted
Average Shares Used in Computation
|
|||||||||||||
|
Basic
|
45,665
|
35,404
|
45,673
|
35,540
|
|||||||||
|
Diluted
|
51,319
|
35,404
|
51,327
|
35,540
|
|||||||||
4