ACURA PHARMACEUTICALS, INC - Quarter Report: 2010 September (Form 10-Q)
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SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20649
Form
10-Q
(Mark
One)
þ
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QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934.
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For the quarterly period ended
September 30, 2010
or
¨
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TRANSACTION REPORT PURSUANT TO
SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
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For the transition period from
______________________ to_______________________
Commission
File Number 1-10113
Acura
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
New
York
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11-0853640
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(State
or other Jurisdiction of
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(I.R.S.
Employer Identification No.)
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incorporation
or organization)
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616
N. North Court, Suite 120
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Palatine,
Illinois
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60067
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(Address
of Principal Executive Offices)
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(Zip
Code)
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847
705 7709
(Registrant's
telephone number, including area code)
(Former
name, former address and former fiscal year, if changed since last
report.)
Indicate by check mark whether the
registrant (1) has filed all reports required to be filed by Section 13 or 15
(d) of the Securities Exchange Act of 1934 during the preceding 12 months, and
(2) has been subject to such filing requirements for the past 90
days. Yes þ No ¨
Indicate by check mark whether the
registrant has submitted electronically and posted on its corporate Web site, if
any, every Interactive Data File required to be submitted and posted pursuant to
Rule 405 S-T (§232.405 of this charter) during the preceding 12 months (or to
such shorter period that the registrant was required to submit and post such
files).
Yes ¨ No
þ
Indicate by check mark whether the
registrant is a large accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of “large” filer,
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. (Check one):
Large
accelerated filer ¨
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Accelerated
filer þ
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Non-accelerated
filer ¨
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Smaller
reporting company ¨
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Indicate by check mark whether the
registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act). Yes ¨ No
þ
As of November 2, 2010 the registrant
had 43,894,514 shares of common stock, $.01 par value, outstanding.
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ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
INDEX
Page No.
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PART
1. FINANCIAL INFORMATION
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Item
1.
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Financial
Statements (Unaudited)
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1
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Consolidated
Balance Sheets
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September
30, 2010 and December 31, 2009
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1
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Consolidated
Statements of Operations
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Nine
and three months ended September 30, 2010 and September 30,
2009
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2
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Consolidated
Statement of Stockholders’ Equity
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Nine
months ended September 30, 2010
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3
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Consolidated
Statements of Cash Flows
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Nine
months ended September 30, 2010 and September 30, 2009
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4
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Notes
to Consolidated Financial Statements
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5
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Item
2.
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Management's
Discussion and Analysis of Financial Condition and Results of
Operations
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10
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Item
4.
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Controls
and Procedures
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16
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PART
II. OTHER INFORMATION
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Item
1.
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Legal
Proceedings
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16
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Item
6.
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Exhibits
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16
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Signatures
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17
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PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
BALANCE SHEETS
UNAUDITED
(in
thousands, except par values)
September 30,
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December 31,
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|||||||
2010
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2009
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|||||||
Assets
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||||||||
Current
assets
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||||||||
Cash
and cash equivalents
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$ | 25,872 | $ | 30,174 | ||||
Collaboration
revenue receivable
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55 | 357 | ||||||
Prepaid
insurance
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336 | 193 | ||||||
Prepaid
expenses and other current assets
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51 | 33 | ||||||
Total
current assets
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26,314 | 30,757 | ||||||
Property,
plant and equipment, net
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1,077 | 1,160 | ||||||
Total
assets
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$ | 27,391 | $ | 31,917 | ||||
Liabilities
and Stockholders’ Equity
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||||||||
Current
liabilities
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||||||||
Deferred
program fee revenue
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$ | 700 | $ | 1,555 | ||||
Accrued
expenses
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622 | 452 | ||||||
Total
current liabilities
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1,322 | 2,007 | ||||||
Commitments
and contingencies (Note 9)
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||||||||
Stockholders’
equity
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||||||||
Common
stock - $.01 par value; 100,000 shares authorized; 43,894 and 43,728
shares issued and outstanding at September 30, 2010 and December 31,
2009
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439 | 437 | ||||||
Additional
paid-in capital
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358,631 | 352,694 | ||||||
Accumulated
deficit
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(333,001 | ) | (323,221 | ) | ||||
Total
stockholders’ equity
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26,069 | 29,910 | ||||||
Total
liabilities and stockholders’ equity
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$ | 27,391 | $ | 31,917 |
See
accompanying notes to the consolidated financial statements.
1
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF OPERATIONS
UNAUDITED
(in
thousands, except per share data)
Nine Months
Ended September 30,
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Three Months
Ended September 30,
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|||||||||||||||
2010
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2009
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2010
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2009
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Revenue
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Program
fee revenue
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$ | 855 | $ | 2,688 | $ | 233 | $ | 583 | ||||||||
Collaboration
revenue
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2,097 | 397 | 59 | 225 | ||||||||||||
Total
revenue
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2,952 | 3,085 | 292 | 808 | ||||||||||||
Operating
expense
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||||||||||||||||
Research
and development expense
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5,714 | 3,828 | 1,142 | 1,494 | ||||||||||||
Marketing,
general and administrative expense
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7,025 | 8,680 | 1,716 | 3,284 | ||||||||||||
Total
operating expense
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12,739 | 12,508 | 2,858 | 4,778 | ||||||||||||
Loss
from operations
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(9,787 | ) | (9,423 | ) | (2,566 | ) | (3,970 | ) | ||||||||
Other
income, net
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17 | 131 | 15 | 20 | ||||||||||||
Loss
before income tax
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(9,770 | ) | (9,292 | ) | (2,551 | ) | (3,950 | ) | ||||||||
Income
tax expense
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10 | 2,459 | 2 | 4 | ||||||||||||
Net
loss
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$ | (9,780 | ) | $ | (11,751 | ) | $ | (2,553 | ) | $ | (3,954 | ) | ||||
Loss
per share - basic and diluted
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$ | (0.21 | ) | $ | (0.26 | ) | $ | (0.05 | ) | $ | (0.09 | ) | ||||
Weighted
average shares – basic and diluted
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46,992 | 45,839 | 47,100 | 45,992 |
See
accompanying notes to the consolidated financial
statements.
2
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENT OF STOCKHOLDERS' EQUITY
NINE
MONTHS ENDED SEPTEMBER 30, 2010
UNAUDITED
(in
thousands, except par values)
Common
Stock
$0.01 Par
Value -
Shares
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Common
Stock
$0.01 Par
Value -
Amount
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Additional
Paid-in
Capital
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Accumulated
Deficit
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Total
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||||||||||||||||
Balance
at December 31, 2009
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43,728 | $ | 437 | $ | 352,694 | $ | (323,221 | ) | $ | 29,910 | ||||||||||
Net
loss
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- | - | - | (9,780 | ) | (9,780 | ) | |||||||||||||
Share-based
compensation
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- | - | 5,547 | - | 5,547 | |||||||||||||||
Exercise
of warrants
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166 | 2 | 390 | - | 392 | |||||||||||||||
Balance
at September 30, 2010
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43,894 | $ | 439 | $ | 358,631 | $ | (333,001 | ) | $ | 26,069 |
See
accompanying notes to the consolidated financial statements.
3
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE NINE MONTHS ENDED SEPTEMBER 30,
UNAUDITED
(in
thousands, except supplemental disclosures)
2010
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2009
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Cash
flows from operating activities
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Net
loss
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$ | (9,780 | ) | $ | (11,751 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities
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Depreciation
and amortization
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101 | 96 | ||||||
Deferred
income taxes
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- | 2,479 | ||||||
Non-cash
share-based compensation expense
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5,547 | 6,529 | ||||||
Loss
on asset dispositions
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14 | 3 | ||||||
Changes
in assets and liabilities
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Collaboration
revenue receivable
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302 | 3,304 | ||||||
Prepaid
expenses and other current assets
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(161 | ) | 91 | |||||
Accounts
payable
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- | (382 | ) | |||||
Accrued
expenses
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170 | (176 | ) | |||||
Deferred
program fee revenue
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(855 | ) | (2,688 | ) | ||||
Net
cash used in operating activities
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(4,662 | ) | (2,495 | ) | ||||
Cash
flows from investing activities
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Capital
expenditures
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(32 | ) | (213 | ) | ||||
Investment
maturities
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- | 5,039 | ||||||
Net
cash (used in) provide by investing activities
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(32 | ) | 4,826 | |||||
Cash
flows from financing activities–proceeds from warrant
exercise
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392 | - | ||||||
(Decrease)
increase in cash and cash equivalents
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(4,302 | ) | 2,331 | |||||
Cash
and cash equivalents at beginning of period
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30,174 | 30,398 | ||||||
Cash
and cash equivalents at end of period
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$ | 25,872 | $ | 32,729 | ||||
Cash
paid during the period for income taxes
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$ | 15 | $ | 102 |
SUPPLEMENTAL
DISCLOSURES OF NONCASH INVESTING AND FINANCING ACTIVITIES
Nine Months Ended September
30, 2010
1.
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We
issued 14,000 shares of common stock after a cashless exercise of a
warrant to acquire 64,000 shares of
stock.
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Nine Months Ended September
30, 2009
1.
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We
issued 193,000 shares of common stock after a cashless exercise of
warrants to acquire 391,000 shares of
stock.
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2.
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We
issued 50,000 shares of common stock after a cashless exercise of an
employee stock option to acquire 100,000 shares of common stock and after
we withheld 50,000 shares from such exercise to pay $173,000 of minimum
statutory withholding payroll taxes.
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See
accompanying notes to the consolidated financial statements.
4
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER
30, 2010 AND 2009
NOTE
1 BASIS OF PRESENTATION
Acura
Pharmaceuticals, Inc., a New York corporation, and its wholly-owned subsidiary
Acura Pharmaceutical Technologies, Inc. (the “Company” or “We”) is a specialty
pharmaceutical company engaged in research, development and manufacture of
product candidates intended to introduce limits and impediments to abuse by
utilizing our proprietary Aversion®
Technology, Impede™ Technology and other novel technologies.
The
accompanying unaudited consolidated financial statements of the Company were
prepared in accordance with generally accepted accounting principles for interim
financial information and instructions to Form 10-Q and Rule 10-01 of Regulation
S-X. Accordingly, these financial statements do not include all of
the information and footnotes required by accounting principles generally
accepted in the United States of America for complete financial
statements. In the opinion of management, all adjustments considered
necessary to present fairly the Company’s financial position, results
of operations and cash flows have been made. The results
of operations for the three and nine months ended September 30, 2010 are not
necessarily indicative of results expected for the full year ending December 31,
2010. These unaudited consolidated financial statements should be
read in conjunction with the audited consolidated financial statements and
footnotes thereto for the year ended December 31, 2009 included in the Company's
Annual Report on Form 10-K filed with the Securities and Exchange Commission.
The 2009 year-end consolidated balance sheet presented in this Report was
derived from the Company’s 2009 year-end audited consolidated financial
statements, but does not include all disclosures required by generally accepted
accounting principles. Amounts presented in the financial statements are rounded
to the nearest thousand except per share data and par values.
NOTE
2 RESEARCH AND DEVELOPMENT
Research
and Development (“R&D”) expenses include internal R&D activities,
external Contract Research Organization (“CRO”) services and their clinical
research sites, and other activities. Internal R&D activity expenses
include facility overhead, equipment and facility maintenance and repairs,
laboratory supplies, pre-clinical laboratory experiments, depreciation,
salaries, benefits, and share-based compensation expenses. CRO activity expenses
include preclinical laboratory experiments and clinical trial studies. Other
activity expenses include regulatory consulting, and regulatory legal counsel.
Internal R&D activities and other activity expenses are charged to
operations as incurred. We make payments to the CRO's based on agreed upon
terms and may include payments in advance of a study starting date. We review
and accrue CRO expenses and clinical trial study expenses based on services
performed and rely on estimates of those costs applicable to the stage of
completion of a study as provided by the CRO. Accrued CRO costs are
subject to revisions as such studies progress to completion. Revisions are
charged to expense in the period in which the facts that give rise to the
revision become known. The Company has entered into several cancelable CRO
arrangements and at September 30, 2010 our obligations under these arrangements
was approximately $0.5 million for services to be incurred as subjects are
enrolled and progress through the studies.
NOTE
3 REVENUE RECOGNITION AND DEFERRED PROGRAM FEE
REVENUE
We
recognize revenue when there is persuasive evidence that an agreement exists,
performance specified in the agreement has occurred, the price is fixed and
determinable, and collection is reasonably assured. In connection with our
License, Development, and Commercialization Agreement dated October 30, 2007
(the “King Agreement”) with King Pharmaceuticals Research and Development, Inc.
(“King”), we recognize program fee revenue, collaboration revenue and milestone
revenue.
Program
fee revenue is derived from amortized upfront payments, such as the $30.0
million upfront payment from King received in December 2007, and license fees,
such as the $3.0 million option exercise fee paid by King to us in each of May
and December 2008 upon the exercise of its option to license a third and fourth
opioid analgesic product candidate under the King Agreement. We have assigned an
equal portion of King’s $30.0 million upfront payment to each of three product
candidates identified in the King Agreement and recognize the upfront payment as
program fee revenue ratably over our estimate of the development period for each
identified product candidate. We expect to recognize the remainder of the
program fee revenue for the third product candidate ratably over its remaining
development period which we currently estimate will extend through June
2011.
5
Collaboration
revenue is derived from reimbursement of development expenses, which are
invoiced quarterly in arrears, and are recognized when costs are incurred
pursuant to the King Agreement. The ongoing R&D services being
provided to King under the King Agreement are priced at fair value based upon
the reimbursement of expenses incurred pursuant to the King
Agreement.
Milestone
revenue is contingent upon the achievement of certain pre-defined events in the
King Agreement. Milestone payments from King are recognized as revenue upon
achievement of the “at risk” milestone events. Milestone payments are triggered
either by the results of our R&D efforts or by events external to us, such
as regulatory approval to market a product. As such, the milestones were
substantially at risk at the inception of the King Agreement and the amounts of
the revenue correspond to the milestone payments set forth in the King
Agreement. In addition, upon the achievement of a milestone event, we
have no future performance obligations related to that milestone. Milestone
revenue is non-refundable and non-creditable when payments are made to us by
King.
NOTE
4 INCOME TAXES
The
Company accounts for income taxes under the liability method. Under this method,
deferred income tax assets and liabilities are determined based on differences
between financial reporting and income tax basis of assets and liabilities and
are accounted for using the enacted income tax rates and laws that will be in
effect when the differences are expected to reverse. Additionally, net operating
loss and tax credit carryforwards are reported as deferred income tax
assets. The realization of deferred income tax assets is dependent
upon future earnings. A valuation allowance is required against deferred income
tax assets if, based on the weight of available evidence, it is more likely than
not that some or all of the deferred income tax assets may not be realized. At
both September 30, 2010 and December 31, 2009 all our remaining net deferred
income tax assets were offset by a valuation allowance due to uncertainties with
respect to future utilization of net operating loss carryforwards. If in the
future it is determined that additional amounts of our deferred income tax
assets would likely be realized, the valuation allowance would be reduced in the
period in which such determination is made and an additional benefit from income
taxes in such period would be recognized.
NOTE
5 ACCRUED EXPENSES
Accrued
expenses are summarized as follows:
Sept 30,
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Dec 31,
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|||||||
(in thousands)
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2010
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2009
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||||||
Payroll,
payroll taxes, bonus and benefits
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$ | 322 | $ | 89 | ||||
Legal
and accountant services
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155 | 160 | ||||||
State
franchise taxes
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- | 21 | ||||||
Property
taxes
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21 | 19 | ||||||
Clinical
and regulatory services
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33 | 75 | ||||||
Other
fees and services
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91 | 88 | ||||||
$ | 622 | $ | 452 |
NOTE
6 SHARE-BASED COMPENSATION
The
Company has share-based compensation plans including stock options and
restricted stock units (“RSUs”) for its employees and directors. The
Company accounts for compensation cost related to share-based payments based on
fair value of the stock options and RSUs when awarded to an employee or
director. The value of the portion of the award that is ultimately
expected to vest is recognized as expense in the relevant accounting periods in
the Company’s consolidated financial statement. The Company uses the straight
line amortization method for calculating share-based compensation expense. The
Company determines the estimated fair value of share-based stock option awards
using the Black-Scholes option pricing model. Option valuation models require
the input of highly subjective assumptions including the expected volatility of
the market price of the Company’s common stock as determined by reviewing its
historical public market closing prices, risk-free interest rate and expected
dividend yields. The Company does not consider implied volatility because there
are no options traded in its stock. The risk – free interest rate assumption is
based on observed interest rates appropriate for the estimated term of the
employee stock options. The dividend yield assumption is based on the Company’s
history and current expectation of dividend payouts on common stock. The
expected term of the award represents the period that the employees and
directors are expected to hold the award before exercise and issuance using
historical exercise activity. The Company’s accounting for share-based
compensation for RSUs is also based on the fair-value method. The fair value of
the RSUs is based on the closing market price of the Company’s common stock on
the date of the RSU award.
6
Our
non-cash share-based compensation expense comprises the following (in
thousands):
Nine Months Ended
September 30,
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Three Months Ended
September 30,
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|||||||||||||||
2010
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2009
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2010
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2009
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Research and development
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Stock
Options
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$ | 1,151 | $ | 1,204 | $ | 267 | $ | 498 | ||||||||
RSUs
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209 | 133 | 70 | 70 | ||||||||||||
1,360 | 1,337 | 337 | 568 | |||||||||||||
General
and administrative
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||||||||||||||||
Stock
Options
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3,674 | 4,687 | 691 | 1,853 | ||||||||||||
RSUs
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513 | 505 | 171 | 254 | ||||||||||||
4,187 | 5,192 | 862 | 2,107 | |||||||||||||
Total
share-based compensation expense
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$ | 5,547 | $ | 6,529 | $ | 1,199 | $ | 2,675 |
Stock
Option Award Plans
At
September 30, 2010, the Company has stock options issued and outstanding under
three stock option plans. The Company’s 1995 and 1998 Stock Option
Plans have expired but stock options awarded under such plans remain outstanding
under the terms of those plans. The Company’s 2008 Stock Option Plan remains in
effect. Under the 1998 and 2008 stock option plans, only one-fourth of vested
non-incentive stock options (“NonISO”) may be exercised during each of calendar
years 2011, 2012, 2013 and 2014.
Exercise
of NonISO stock option shares by employees may require the Company to make
minimum statutory withholding tax (“withholding tax”) payments for such employee
on any gain on such shares at the time of exercise. The employee is
responsible for providing sufficient funds to the Company to make such
withholding tax payments. However, under the Company’s stock option
plans, the employee may elect to take a partial distribution of the exercised
NonISO shares and have the Company retain the balance of the exercised shares in
satisfaction of the employee’s withholding tax payments. In such an
event, the Company becomes obligated to directly pay the withholding taxes of
such employee and will retain a sufficient number of exercised shares such that
the fair market value of the retained shares will offset the employee’s
withholding taxes. The Company has not reflected this obligation as a liability
in its consolidated financial statements as the withholding tax payments are
contingent upon the timing and number of NonISO stock options
exercised by employees and the closing market price of our
common stock at the time of exercise. Such withholding taxes will be paid and
charged against additional paid in capital as the NonISO stock options are
exercised.
At
September 30, 2010, stock options to purchase 3.7 million common shares were
outstanding of which 3.4 million and 2.7 million stock options were vested at
September 30, 2010 and December 31, 2009, respectively. The aggregate intrinsic
value of the stock option awards fully vested and outstanding at September 30,
2010 was $1.4 million. There were no stock options granted
during either of the three month periods ended September 30, 2010 or
2009. During the nine month period ended September 30, 2010 and 2009,
stock options to purchase 0.1 million shares and 1.3 million shares of common
stock having a weighted average exercise price of $5.47 and $6.38 were granted
and 0.05 million and 0.02 million stock options expired, respectively. During
the nine month period ended September 30, 2009 stock options for 0.1 million
shares were exercised at a price of $1.30 per share.
7
Assumptions
used in the Black-Scholes model to determine fair value for the 2010 and 2009
stock option awards were:
2010
|
2009
|
|||||||
Dividend
yield
|
0.0 | % | 0.0 | % | ||||
Average
risk-free interest rate
|
3.85 | % | 2.77 | % | ||||
Average
volatility
|
122 | % | 124 | % | ||||
Expected
forfeitures
|
0.0 | % | 0.0 | % | ||||
Expected
holding period
|
10 years
|
10 years
|
||||||
Weighted
average grant date fair value
|
$ | 5.23 | $ | 6.06 |
As of
September 30, 2010 the Company had $2.0 million of unrecognized share-based
compensation expense from stock option grants, which will be recognized in our
consolidated financial statements over their remaining vesting periods. Under
the stock option plans, if a change in control occurs, an acceleration of
unvested shares will occur and any remaining unrecognized share-based
compensation expense will be recognized in our consolidated financial
statements.
Restricted
Stock Unit Award Plan
The
Company has RSUs issued and outstanding under a Restricted Stock Unit Award Plan
(“2005 RSU Plan”) for its employees and directors. A RSU represents the
contingent obligation of the Company to deliver a share of its common stock to
the holders of a vested RSU on a specified distribution date. For the
2005 RSU Plan, absent a change of control, one-fourth of vested shares of common
stock underlying an RSU award will be distributed on January 1 of each of 2011,
2012, 2013 and 2014. If a change in control occurs (whether prior to or after
2011), an acceleration of unvested shares will occur and all shares underlying
the RSU award will be distributed at or about the time of the change in control
and any unrecognized share-based compensation expense will be recognized in our
consolidated financial statements.
Distribution
of RSU shares to employees may require the Company to make minimum statutory
withholding tax (“withholding tax”) payments for such employee on any gain on
such shares at the time of distribution. The employee is responsible
for providing sufficient funds to the Company to make such withholding tax
payments. However, under the 2005 RSU Plan, the employee may elect to
take a partial distribution of shares and have the Company retain the balance of
the share distribution in satisfaction of the withholding tax
payments. In such an event, the Company becomes obligated to directly
pay the withholding taxes of such employee and will retain a sufficient number
of shares such that the fair market value of the retained shares will offset the
employee’s withholding taxes. The Company has not reflected this
obligation as a liability in its consolidated financial statements as the
withholding tax payments are contingent upon the timing and number
of RSU shares distributed to employees and the closing market price
of our common stock at the time of distribution. Such withholding taxes will be
paid and charged against additional paid-in capital as the RSU shares are
distributed.
At
September 30, 2010 and December 31, 2009, 3.32 million RSUs were outstanding of
which 3.23 million and 3.11 million were fully vested, respectively. The
aggregate intrinsic value of the RSU awards fully vested and outstanding at
September 30, 2010 was $8.0 million. There were no RSUs granted
during either of the three month periods ended September 30, 2010 or
2009. There were no RSUs granted during the nine month period ended
September 30, 2010. During the nine month period ended 2009, awards
of 0.33 million RSUs were granted having a fair value of $2.1 million. As of
September 30, 2010, the Company had $0.5 million of unrecognized share-based
compensation expense from RSU activity which will be recognized in our
consolidated financial statements over their remaining vesting periods unless a
change in control occurs as described above.
NOTE
7 COMMON STOCK WARRANTS
At
September 30, 2010, the Company had common stock warrants outstanding
exercisable for 2.2 million shares of common stock at an exercise price of $3.40
per share with an expiration date of August 2014.
NOTE
8 EARNINGS (LOSS) PER SHARE
Computation
of basic earnings (loss) per share of common stock is based on the sum of the
weighted average number of outstanding common shares and vested restricted stock
units (“RSUs”) during the period. Computation of diluted earnings (loss) per
share is based on the sum of the common shares and vested RSUs used in the basic
earnings (loss) computation, adjusted for the effect of other potentially
dilutive securities. Excluded from the diluted earnings (loss) per share
computation at September 30, 2010 and 2009 are 6.0 million and 8.0 million,
respectively, of potentially dilutive securities, as the effect of including
these securities would be antidilutive.
8
Nine Months Ended
September 30,
|
Three Months Ended
September 30,
|
|||||||||||||||
(in thousands, except per share data)
|
2010
|
2009
|
2010
|
2009
|
||||||||||||
Basic
and diluted loss per share computation
|
||||||||||||||||
Numerator:
|
||||||||||||||||
Net
loss
|
$ | (9,780 | ) | $ | (11,751 | ) | $ | (2,553 | ) | $ | (3,954 | ) | ||||
Denominator:
|
||||||||||||||||
Common
shares (weighted)
|
43,825 | 42,841 | 43,895 | 42,958 | ||||||||||||
Vested
RSUs (weighted)
|
3,167 | 2,998 | 3,205 | 3,034 | ||||||||||||
Weighted
average number of shares outstanding
|
46,992 | 45,839 | 47,100 | 45,992 | ||||||||||||
Basic
and diluted loss per common share
|
$ | (0.21 | ) | $ | (0.26 | ) | $ | (0.05 | ) | $ | (0.09 | ) | ||||
Excluded
potentially dilutive securities:
|
||||||||||||||||
Common
shares issuable (1):
|
||||||||||||||||
Nonvested
RSUs
|
88 | 270 | 88 | 270 | ||||||||||||
Common
stock options (vested and nonvested)
|
3,713 | 4,164 | 3,713 | 4,164 | ||||||||||||
Common
stock warrants
|
2,193 | 3,517 | 2,193 | 3,517 | ||||||||||||
Total
excluded dilutive common stock equivalents
|
5,994 | 7,951 | 5,994 | 7,951 |
(1)
Number of shares issuable represents those securities which were either i)
nonvested at period end or ii) were vested but antidilutive. The number of
shares is based on maximum number of shares issuable on exercise at period end.
Such amounts have not been adjusted for the treasury stock method or weighted
average outstanding calculations as required if the securities were
dilutive.
NOTE
9 COMMITMENTS AND CONTINGENCIES
Securities
and Class Action Litigation
A lawsuit
captioned Bang v. Acura
Pharmaceuticals, et al, was filed on September 10, 2010 in the United
States District Court for the Northern District of Illinois, Eastern Division
(Case 1:10-cv-05757) against us and certain of our current and former officers
seeking unspecified damages on behalf of a putative class of persons who
purchased our common stock between February 21, 2006 and April 22, 2010. The
complaint alleges that certain Company officers made false or misleading
statements, or failed to disclose material facts in order to make statements not
misleading, relating to our Acurox® product
candidate, resulting in violations of Section 10(b) of the Securities Exchange
Act of 1934 (the “Exchange Act”), Rule 10b-5 under the Exchange Act and Section
20(a) of the Exchange Act. The complaint further alleges that such
false or misleading statements or omissions had the effect of artificially
inflating the price of our common stock. We believe that the allegations
in the complaint are without merit and intend to vigorously defend the
litigation
On
October 25, 2010, Kiley Hill, a purported stockholder of the Company filed a
shareholder derivative action in the Circuit Court of Cook County, Illinois,
Chancery Division captioned Hill v. Acura Pharmaceuticals
et al. (Case No. 2010-CH-46380), against our directors and certain of our
executive officers, generally relating to the same events that are the subject
of the class action litigation described above. The complaint purports to be
brought on our behalf and names us as a nominal defendant. The complaint seeks
unspecified damages from the individual defendants for breaches of fiduciary
duty, abuse of control, gross mismanagement, contribution and indemnification,
waste of corporate assets and unjust enrichment for actions occurring from at
least February 21, 2006 through April 22, 2010. Substantively similar
complaints captioned Hagan v.
Acura Pharmaceuticals et al. (Case No. 2010-CH-46621) and Newell v. Reddick et al (Case
No. 2010-CH-46873) were filed in the Circuit Court of Cook County, Illinois,
Chancery Division, by other purported stockholders of the Company on October 27,
2010 and October 28, 2010, respectively.
9
Reglan®/Metoclopramide
Litigation
Halsey
Drug Company, as predecessor to the Company, has been named along with numerous
other companies as a defendant in two separate state coordinated litigations
pending in Pennsylvania and New Jersey, respectively captioned In re: Reglan® /Metoclopramide Mass
Tort Litigation, Philadelphia County Court of Common Pleas, January Term,
2010, No. 01997 and In re:
Reglan® Litigation, Superior Court of New Jersey, Law Division, Atlantic
County, Case No. 289, Master Docket No. ATL-L-3865-10. In this
product liability litigation against numerous pharmaceutical product
manufacturers and distributors, including the Company, plaintiffs claim injuries
from their use of the Reglan® brand of metoclopramide and
generic metoclopramide. In the Pennsylvania state court mass tort
proceeding, approximately 40 lawsuits have been filed alleging that Plaintiffs
developed neurological disorders as a result of their use of the Reglan® brand
and/or generic metoclopramide. Plaintiffs have not yet filed any
individual lawsuits against the Company in the New Jersey action. In
the lawsuits filed to date, Plaintiffs have not confirmed they ingested any of
the generic metoclopramide manufactured by the Company. The Company
had discontinued manufacture and distribution of generic metoclopramide more
than 15 years ago. The Company believes these claims are without
merit and will vigorously defend these actions.
Item
2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations
This
discussion and analysis should be read in conjunction with the Company's
financial statements and accompanying notes included elsewhere in this
Report. Historical operating results are not necessarily indicative
of results in future periods.
Forward-Looking
Statements
Certain
statements in this Report 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 and the ability of
King Pharmaceuticals Research and Development, Inc. (“King”) (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 or Impede™ Technology, to obtain necessary regulatory approvals and
commercialize products utilizing such technologies, 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 laboratory and clinical studies we may
complete in the future, to support FDA approval of our product candidates, the
adequacy of the development program for our product candidates, including
whether additional clinical studies will be required to support FDA approval of
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 the risk that further studies of our product
candidates are not positive or otherwise do not support FDA approval, whether or
when we are able to obtain FDA approval of labeling for our product candidates
for the proposed indications or for abuse deterrent features, whether our
product candidates will ultimately deter abuse in commercial settings, and the
uncertainties inherent in scientific research, drug development, laboratory and
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 skilled personnel; our ability to
secure and protect our patents, trademarks and other 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
quotas and source the active ingredients for our products in development;
difficulties or delays in conducting clinical trials for our product candidates
or in the commercial manufacture and supply of our products; and other risks and
uncertainties detailed in this Report and in our 2009 Annual Report on Form 10-K
filed with the Securities and Exchange Commission. When used on this
website, the words "estimate," "project," "anticipate," "expect," "intend,"
"believe," and similar expressions identify forward-looking
statements.
10
Company
Overview
We are a
specialty pharmaceutical company engaged in research, development and
manufacture of product candidates intended to introduce limits or impediments to
abuse utilizing our proprietary Aversion® and Impede™
Technologies. Our Aversion®
Technology opioid analgesic product candidates are intended to effectively
relieve pain while simultaneously introducing limits or impediments to common
methods of opioid product misuse and abuse, including the:
|
·
|
intravenous
injection of dissolved tablets or
capsules;
|
|
·
|
nasal
snorting of crushed tablets or capsules;
and/or
|
|
·
|
intentional
swallowing of excess quantities of tablets or
capsules.
|
Acurox®
(oxycodone HCl) Tablets (without niacin)
We and
King Pharmaceuticals R&D (“King”) are jointly developing opioid analgesic
product candidates both with and without niacin utilizing our patented Aversion®
Technology. In developing Acurox® Tablets (without niacin) we and
King have completed two Phase 1 pharmacokinetic (PK) studies demonstrating: (a)
Acurox® Tablets are bioequivalent to the anticipated reference listed drug under
fasted conditions, and (b) Acurox® Tablets have greater total oxycodone plasma
levels with a lower peak drug concentration under fed compared to fasted
conditions. We expect these PK studies will provide the basis for
establishing safety and analgesic efficacy of Acurox® Tablets for inclusion in a
505(b)(2) NDA submission to the FDA by King. We have also completed
laboratory tests characterizing the impediments to abusing Acurox® Tablets by
intravenous administration. In addition, King has completed a Phase 2
clinical like/dislike study of crushed Acurox® Tablets administered intranasally
in recreational opioid abusers. On September 27, 2010, King and Acura
met with the FDA to discuss the contents of an Acurox® Tablets NDA submission
acceptable to FDA for filing. As a result of this pre-NDA meeting, we
currently expect King to submit an NDA for Acurox® Tablets to the FDA in the
first quarter of 2011.
A primary
market research survey of 401 opioid prescribing physicians suggests that
regardless of whether Acurox® Tablets contain niacin or do not contain niacin,
Acurox® has the potential for garnering a substantial share of immediate release
opioid analgesics prescriptions, although there can be no assurance in this
regard. This finding was confirmed in a separate primary market
research study of 435 physicians which concluded the particular combination of
ingredients [i.e. with or without niacin] does not appear to have a substantial
effect on the estimated brand market share potential.
Acurox®
with Niacin (oxycodone HCl/niacin) Tablets
We and
King are analyzing the results from study AP-ADF-114 (Study 114), an abuse
liability study comparing the like/dislike scores of excess oral doses of
Acurox® with Niacin Tablets to excess oral doses of oxycodone HCl tablets alone
without niacin. Study 114 was not included in the original NDA filing
for Acurox® with Niacin Tablets for which we received an FDA Complete Response
Letter (“CRL”) in June 2009. We intend to complete our Study 114
analyses and associated Clinical Study Report and respond to the FDA’s CRL for
Acurox® with Niacin Tablets.
All of
our opioid product candidates utilizing Aversion® Technology (with or without
niacin) are encompassed by two issued U.S. patents, which in combination with
our anticipated product labeling and drug product listing strategies are
anticipated to provide our opioid products licensed to King with protection from
generic competition through the expiration of our patents in 2025.
Impede™
PSE Tablets
We have
developed a pseudoephedrine hydrochloride (PSE) tablet product candidate
utilizing our Impede™ Technology. Impede™ Technology utilizes a
proprietary mixture of functional inactive ingredients intended to limit or
impede extraction of PSE from the tablets for use as a starting material in
producing the illicit drug methamphetamine. The unique mixture of
inactive ingredients in the Impede™ PSE product candidate are generally
recognized as safe.
We
sponsored an independent pharmaceutical laboratory test of our Impede™ PSE
tablets compared to Sudafed®* brand PSE tablets in an attempt to extract PSE
from 100 x 30 mg tablets for conversion to methamphetamine using what we believe
to be the three most commonly used conversion processes. The results
of these tests demonstrated that while PSE was readily extracted from Sudafed®
tablets, Impede™ PSE effectively impeded the extraction of the PSE for
conversion into methamphetamine. The results of these tests are
summarized in the table below:
11
% Pseudoephedrine HCl extracted
from 100 x 30mg tablets
|
||||||||||||
Product Tested
|
Method 1
|
Method 2
|
Method 3
|
|||||||||
Impede™
PSE Tablets
|
0 | % | 0 | % | 0 | % | ||||||
Sudafed®
Tablets
|
96 | % | 89 | % | 79 | % |
*Sudafed®
is a registered trademark of Johnson and Johnson Corporation
Tablet
products containing 60 mg or less of PSE are considered by the FDA to be safe
and effective for use by the general public without a
prescription. We believe our 30 mg PSE tablet product developed
utilizing Impede™ Technology meets or will meet the FDA’s requirements for
“Over-the-Counter Human Drugs Which are Generally Recognized as Safe and
Effective and Not Misbranded” as set forth in the Code of Federal Regulations at
21CFR330.1 which will allow us to commercialize our Impede™ PSE Tablets without
submitting a new drug application (NDA) to the FDA. We are
currently evaluating commercialization strategies for our Impede™ PSE
Tablets.
Additional
Product Candidates
We are
developing a benzodiazepine tablet product candidate utilizing our Aversion®
Technology. The primary active ingredient in this product candidate is
intended for the treatment of anxiety disorders. Benzodiazepine products
are classified as Schedule IV controlled substances by the U.S. Drug Enforcement
Administration (“DEA”).
King
Agreement
We have
entered into a license agreement (the “King Agreement”) with King to develop and
commercialize in the United States, Canada and Mexico (the "King Territory")
Acurox® Tablets,
Acuracet®
Tablets, Vycavert® Tablets
and a fourth undisclosed opioid analgesic product candidate utilizing our
proprietary Aversion®
Technology. King has an option to license in the King Territory
certain future opioid analgesic products developed utilizing our Aversion®
Technology.
We are
responsible, using commercially reasonable efforts, for all Acurox® with
Niacin Tablet development activities through FDA approval of a 505(b)(2) NDA,
for which certain expenses are reimbursed to us by King. After NDA approval, for
which no assurances can be given, King will be responsible for manufacturing and
commercializing Acurox® with
Niacin Tablets in the U.S. With respect to all other products
licensed by King pursuant to the King Agreement in all King Territories,
including Acurox® Tablets (without niacin), King will be responsible, at its own
expense, for development, regulatory, manufacturing and commercialization
activities.
As of
September 30, 2010 we have received aggregate payments of $58.3 million from
King, consisting of a $30.0 million non-refundable upfront cash payment, $17.3
million in reimbursed R&D expenses relating to Acurox® Tablets,
$6.0 million in fees relating to King’s exercise of its option to license each
of an undisclosed opioid analgesic tablet product and Vycavert® Tablets,
and a $5.0 million milestone fee for successful achievement of the primary
endpoints for our pivotal Phase III clinical study for Acurox® with
Niacin Tablets. The King Agreement provides for King to pay us: (a) a
$3.0 million option exercise fee for each future opioid product candidate King
licenses, (b) up to $23 million in regulatory milestone payments for each King
licensed product candidate, including Acurox® Tablets,
in specific countries in the King Territory, and (c) a one-time $50 million
sales milestone payment upon the first attainment of an aggregate of $750
million in net sales of all of our licensed products combined in all King
Territories. In addition, for sales occurring following the one year
anniversary of the first commercial sale of the first licensed product sold,
King will pay us a royalty at one of six rates ranging from 5% to 25% based on
the level of combined annual net sales for all products licensed by us to King
in all King Territories, with the highest applicable royalty rate applied to
such combined annual sales. No minimum annual fees are payable by
either party under the King Agreement.
Under the
terms of the King Agreement, King may terminate the Agreement (i) in its
entirety at any time by written notice to Acura and (ii) with respect to an
individual product by providing 12 month advance notice to
Acura.
12
The
foregoing description of the King Agreement contains forward-looking statements
about Acurox® Tablets,
Acurox® with Niacin Tablets, and other product candidates pursuant to the King
Agreement. As with any pharmaceutical products under development or
proposed to be developed, substantial risks and uncertainties exist in
development, regulatory review and commercialization process. There
can be no assurance that any product developed, in whole or in part, pursuant to
the King Agreement will receive regulatory approval or prove to be commercially
successful. Accordingly, investors in the Company should recognize
that there is no assurance that the Company will receive the milestone payments
or royalty revenues described in the King Agreement or even if such milestones
are achieved, that the related products will be successfully commercialized and
that any royalty revenues payable to us by King will materialize.
On
October 12, 2010 Pfizer, Inc. announced a tender offer to acquire all of the
outstanding shares of King Pharmaceuticals, Inc. Pfizer and King are
targeting a late fourth quarter 2010 or first quarter 2011 closing assuming
execution of the tender process and receipt of the appropriate regulatory
clearances. Depending on the structure of the Pfizer/King transaction, Pfizer
will assume King's obligations under the King Agreement (if King does not
survive as a subsidiary of Pfizer) or King will remain the responsible party
under the King Agreement (if King survives as a subsidiary of
Pfizer).
Patents
and Patent Applications
In April
2007, the United States Patent and Trademark Office (“USPTO”), issued to us a
patent titled “Methods and Compositions for Deterring Abuse of Opioid Containing
Dosage Forms” (the “920 Patent”). The 54 allowed claims in the 920
Patent encompass certain pharmaceutical compositions intended to deter the most
common methods of prescription opioid analgesic product misuse and abuse. These
patented pharmaceutical compositions include specific opioid analgesics such as
oxycodone HCl and hydrocodone bitartrate among others.
In
January 2009, the USPTO issued to us a patent (the “402 Patent”) with 18 allowed
claims. The 402 Patent encompasses certain combinations of kappa and mu opioid receptor agonists
and other ingredients intended to deter opioid analgesic product misuse and
abuse.
In March
2009, the USPTO issued to us a patent (the “726 Patent”) with 20 allowed
claims. The 726 Patent encompasses a wider range of abuse deterrent
compositions than our 920 Patent.
In
addition to our issued U.S. patents, we have filed multiple U.S. patent
applications and international patent applications relating to compositions
containing abuseable active pharmaceutical ingredients. Except for
those rights conferred in the King Agreement, we have retained all intellectual
property rights to our Aversion® Technology, Impede™ Technology, and related
product candidates.
Company’s
Present Financial Condition
At
November 2, 2010, we had cash and cash equivalents of approximately $25.5
million. We estimate that our current cash reserves will be sufficient to fund
operations and the development of Aversion® and Impede™ Technologies and related
product candidates through at least the next 12 months.
We have
yet to generate any revenues or royalty revenues from product
sales. We expect to rely on our current cash resources and additional
payments that may be made under the King Agreement and under similar license
agreements with other pharmaceutical company partners, of which there can be no
assurance, in funding our continued operations. Our cash requirements
for operating activities may increase in the future as we continue to conduct
pre-clinical studies and clinical trials for our product candidates, maintain,
defend, if necessary and expand the scope of our intellectual property, incur
litigation costs, hire additional personnel, or invest in other
areas.
Results of Operations for
the Nine Months Ended September 30, 2010 and 2009
September 30,
|
Increase (Decrease)
|
|||||||||||||||
($ in thousands):
|
2010
|
2009
|
Dollars
|
%
|
||||||||||||
Revenue
|
||||||||||||||||
Program
fee revenue
|
$ | 855 | $ | 2,688 | $ | (1,883 | ) | (68 | )% | |||||||
Collaboration
revenue
|
2,097 | 397 | 1,700 | 428 | ||||||||||||
Total
revenue
|
2,952 | 3,085 | (133 | ) | (4 | ) | ||||||||||
Operating
expense
|
||||||||||||||||
Research
and development expense
|
5,714 | 3,828 | 1,886 | 49 | ||||||||||||
Marketing,
general and administrative expense
|
7,025 | 8,680 | (1,655 | ) | (19 | ) | ||||||||||
Total
operating expense
|
12,739 | 12,508 | 231 | 2 | ||||||||||||
Loss
from operations
|
(9,787 | ) | (9,423 | ) | 364 | 4 | ||||||||||
Other
income, net
|
17 | 131 | (114 | ) | (87 | ) | ||||||||||
Loss
before income tax
|
(9,770 | ) | (9,292 | ) | (478 | ) | 5 | |||||||||
Income
tax expense
|
10 | 2,459 | (2,449 | ) | (100 | ) | ||||||||||
Net
loss
|
$ | (9,780 | ) | $ | (11,751 | ) | $ | (1,971 | ) | (17 | )% |
13
Revenue
King paid
us a $30.0 million upfront fee in connection with the closing of the King
Agreement in December 2007. Revenue recognized in the nine months ended
September 30, 2010 and 2009 from amortization of this upfront fee was $0.9
million and $2.7 million, respectively. We have assigned a portion of the
program fee revenue to each of three product candidates identified under the
King Agreement and expect to recognize the remainder of the program fee revenue
ratably over our estimate of the development period for each of these product
candidates identified in the King Agreement. We currently estimate the
development period will extend through June 2011.
Collaboration
revenue recognized in the nine months ended September 30, 2010 and 2009 was $2.1
million and $0.4 million, respectively, for invoiced reimbursement of our
Acurox® Tablet and Acurox® with Niacin Tablet development expenses incurred
pursuant to the King Agreement. We invoice King in arrears on a calendar quarter
basis for our reimbursable development expenses under the King
Agreement. We expect the amount and timing of collaboration revenue
to fluctuate in relation to the amount and timing of our underlying R&D
expenses.
Operating
Expense
R&D
expense during the nine months ended September 30, 2010 and 2009 were for
product candidates utilizing our Aversion® and
Impede™ Technologies, including costs of preclinical, clinical trials, clinical
supplies and related formulation and design costs, salaries and other personnel
related expenses, and facility costs. Included in the 2010 and 2009
results are non-cash share-based compensation expenses of $1.4 million and $1.3
million, respectively. Excluding the share-based compensation expense, there is
a $1.9 million increase in development expenses primarily attributable to
conducting Study 114 for Acurox® with
Niacin Tablets, our ongoing development activities for our benzodiazepine tablet
product candidate, the initiation of development of an extended release opioid
product candidate and our continuing R&D with a product candidate using our
novel Impede™ Technology.
Marketing
expenses during the nine months ended September 30, 2010 and 2009 primarily
consisted of market research studies on our Aversion® and
Impede™ Technologies. Our G&A expenses primarily consisted of legal, audit
and other professional fees, corporate insurance, and payroll. Included in the
2010 and 2009 results are non-cash share-based compensation expenses of $4.2
million and $5.2 million, respectively. Excluding the share-based compensation
expense, our marketing, general and administrative expenses overall decreased
$0.7 million.
Other
Income
During
the nine months ended September 30, 2010 and 2009, our cash was invested in
accordance with the investment policy approved by our Board of Directors
resulting in minimal interest income earned in 2010 and $0.1 million in
2009 due to the prevailing low interest rates.
Net Loss
The
Company records its tax provision using a 40% effective tax rate. The net loss
for the nine months ended September 30, 2010 includes no federal or state income
tax benefit provisions due to uncertainty of their future
utilization. A state tax provision was recorded for the Company’s
subsidiary operations apportioned to one state jurisdiction. The
Company’s net loss for the nine months ended September 30, 2009 included income
tax expense of $2.5 million recorded when we adjusted our deferred income tax
asset valuation reserve. We determined it was more likely than not that the
Company’s net operating loss carryforwards may not be utilized.
14
Results of Operations for
the Three Months Ended September 30, 2010 and 2009
September 30,
|
Increase (Decrease)
|
|||||||||||||||
($ in thousands):
|
2010
|
2009
|
Dollars
|
%
|
||||||||||||
Revenue
|
||||||||||||||||
Program
fee revenue
|
$ | 233 | $ | 583 | $ | (350 | ) | (60 | )% | |||||||
Collaboration
revenue
|
59 | 225 | (166 | ) | (74 | ) | ||||||||||
Total
revenue
|
292 | 808 | (516 | ) | (64 | ) | ||||||||||
Operating
expense
|
||||||||||||||||
Research
and development expense
|
1,142 | 1,494 | (352 | ) | (24 | ) | ||||||||||
Marketing,
general and administrative expense
|
1,716 | 3,284 | (1,568 | ) | (48 | ) | ||||||||||
Total
operating expense
|
2,858 | 4,778 | (1,920 | ) | (40 | ) | ||||||||||
Loss
from operations
|
(2,566 | ) | (3,970 | ) | (1,404 | ) | (35 | ) | ||||||||
Other
income , net
|
15 | 20 | (5 | ) | (25 | ) | ||||||||||
Loss
before income tax
|
(2,551 | ) | (3,950 | ) | (1,399 | ) | (35 | ) | ||||||||
Income
tax expense
|
2 | 4 | (2 | ) | (50 | ) | ||||||||||
Net
loss
|
$ | (2,553 | ) | $ | (3,954 | ) | $ | (1,401 | ) | (35 | )% |
Revenue
King paid
us a $30.0 million upfront fee in connection with the closing of the King
Agreement in December 2007. Revenue recognized in the three months ended
September 30, 2010 and 2009 from amortization of this upfront fee was $0.2
million and $0.6 million, respectively. We have assigned a portion of the
program fee revenue to each of three product candidates identified under the
King Agreement and expect to recognize the remainder of the program fee revenue
ratably over our estimate of the development period for each of these product
candidates identified in the King Agreement. We currently estimate the
development period will extend through June 2011.
Collaboration
revenue recognized in the three months ended September 30, 2010 and 2009 was
$0.1 million and $0.2 million, respectively, for invoiced reimbursement of our
Acurox® Tablet and Acurox® with Niacin Tablet development expenses incurred
pursuant to the King Agreement. We invoice King in arrears on a calendar quarter
basis for our reimbursable development expenses under the King
Agreement. We expect the amount and timing of collaboration revenue
to fluctuate in relation to the amount and timing of the underlying R&D
expenses.
Operating
Expense
R&D
expense during the three months ended September 30, 2010 and 2009 were for
product candidates utilizing our Aversion® and
Impede™ Technologies, including costs of preclinical, clinical trials, clinical
supplies and related formulation and design costs, salaries and other personnel
related expenses, and facility costs. Included in the 2010 and 2009
results are non-cash share-based compensation expenses of $0.3 million and $0.6
million, respectively. Excluding the share-based compensation expense, there is
a $0.1 million decrease in development expenses. Our ongoing development
activities include our benzodiazepine tablet product candidate, the initiation
of development of an extended release opioid product candidate and our
continuing research efforts with a product candidate using our novel Impede™
Technology.
Marketing
expenses during the three months ended September 30, 2010 and 2009 primarily
consisted of market research studies on our Aversion® and
Impede™ Technologies. Our G&A expenses primarily consisted of legal, audit
and other professional fees, corporate insurance, and payroll. Included in the
2010 and 2009 results are non-cash share-based compensation expenses of $0.9
million and $2.1 million, respectively. Excluding the share-based compensation
expense, our marketing, general and administrative expenses overall decreased
$0.3 million.
Other
Income
During
the three months ended September 30, 2010 and 2009, our cash was invested in
accordance with the investment policy approved by our Board of Directors
resulting in minimal interest income earned in 2010 and 2009 due to the
prevailing low interest rates.
Net Loss
The
Company records its tax provision using a 40% effective tax rate. The net loss
for the three months ended September 30, 2010 includes no federal or state
income tax benefit provisions due to uncertainty of their future utilization.
A state tax provision was recorded for the Company’s subsidiary
operations apportioned to one state jurisdiction.
15
Liquidity
and Capital Resources
At
September 30, 2010, the Company had unrestricted cash and cash equivalents of
$25.9 million compared to $30.2 million at December 31, 2009. The Company had
working capital of $25.0 million at September 30, 2010 compared to $28.8 million
at December 31, 2009. The decrease in our cash position is primarily due to the
period’s net loss adjusted for certain non-cash items such as deferred program
fee revenue and share-based compensation expenses offset by the collection of
our collaboration revenue receivable and from the cash exercise of outstanding
warrants.
At
November 2, 2010, the Company had cash and cash equivalents of approximately
$25.5 million. The Company estimates that such cash reserves will be sufficient
to fund the development of product candidates and related operating expenses at
least through the next 12 months.
Note A of
the Notes to Consolidated Financial Statements, in the Company’s 2009 Annual
Report on Form 10-K, includes a summary of the Company's significant accounting
policies and methods used in the preparation of the financial statements. The
application of these accounting policies involves the exercise of judgment and
use of assumptions as to future uncertainties and, as a result, actual results
could differ from these estimates. The Company's critical accounting policies
described in the 2009 Annual Report are also applicable to
2010.
Item
4. Controls and Procedures
(a) Disclosure
Controls and Procedures. The Company’s
management, with the participation of the Company’s Chief Executive Officer and
Chief Financial Officer, has evaluated the effectiveness of the Company’s
disclosure controls and procedures (as such term is defined on Rules 13a – 13(e)
and 15(d) – 15(e) under the Exchange Act) as of the end of the period covered by
this Report. The Company’s disclosure controls and procedures are designed to
provide reasonable assurance that information is recorded, processed, summarized
and reported accurately and on a timely basis in the Company’s periodic reports
filed with the SEC. Based upon such evaluation, the Company’s Chief Executive
Officer and Chief Financial Officer have concluded that, as of the end of such
period, the Company's disclosure controls and procedures are effective to
provide reasonable assurance. Notwithstanding the foregoing, a control system,
no matter how well designed and operated, can provide only reasonable, not
absolute assurance that it will detect or uncover failures within the Company to
disclose material information otherwise require to be set forth in the Company’s
periodic reports.
(b) Changes
in Internal Controls over Financial Reporting. There were no changes in
our internal controls over financial reporting during the third fiscal quarter
of 2010 that have materially affected, or are reasonably likely to materially
affect, our internal controls over financial reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
The
information required by this Item is incorporated by reference to Note 9,
“Commitments and Contingencies,” in Part I, Item 1, “Financial
Statements.”
The exhibits required by this Item are
listed below.
31.1
|
Certification
of Periodic Report by Chief Executive Officer pursuant to Rule 13a-14 and
15d-14 of the Securities Exchange Act of
1934.
|
16
31.2
|
Certification
of Periodic Report by Chief Financial Officer pursuant to Rule 13a-14 and
15d-14 of the Securities Exchange Act of
1934.
|
32.1
|
Certification
of Periodic Report by the Chief Executive Officer and Chief Financial
Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of
2002.
|
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.
November
2, 2010
|
ACURA
PHARMACEUTICALS, INC.
|
/s/ Andrew D. Reddick
|
|
Andrew
D. Reddick
|
|
President
& Chief Executive Officer
|
|
/s/ Peter A. Clemens
|
|
Peter
A. Clemens
|
|
Senior
VP & Chief Financial
Officer
|
17