ACURA PHARMACEUTICALS, INC - Quarter Report: 2008 June (Form 10-Q)
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20649
Form
10-Q
(Mark
One)
þ
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934.
|
For
the quarterly period ended June 30, 2008
|
|
or
|
|
o
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TRANSACTION
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
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
|
11-0853640
|
(State
or other Jurisdiction of
|
(I.R.S.
Employer Identification No.)
|
incorporation
or organization)
|
616
N. North Court, Suite 120
|
|
Palatine,
Illinois
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60067
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
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
o
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 o
|
Accelerated
filer o
|
Non-accelerated
filer þ
|
Smaller
reporting company o
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o
No
þ
As
of
July 29, 2008 the registrant had 42,723,254 shares of Common Stock, $.01 par
value, outstanding.
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
INDEX
PART
1. FINANCIAL INFORMATION
Page No.
|
||
Item
1.
|
Financial
Statements (Unaudited)
|
|
Consolidated
Balance Sheets June 30, 2008 and December 31, 2007
|
1
|
|
Consolidated
Statements of Operations Three months and six months ended June 30,
2008
and June 30, 2007
|
2
|
|
Consolidated
Statement of Stockholders’ Equity Six months ended June 30, 2008
|
3
|
|
Consolidated
Statements of Cash Flows Six months ended June 30, 2008 and June
30, 2007
|
4
|
|
Notes
to Consolidated Financial Statements
|
6
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of Operations
|
12
|
Item
4.
|
Controls
and Procedures
|
18
|
PART
II. OTHER INFORMATION
|
||
Item
1A.
|
Risk
Factors Relating to the Company
|
18
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
19
|
Item
6.
|
Exhibits
|
20
|
Signatures
|
21
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial
Statements
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
BALANCE SHEETS
UNAUDITED
(in
thousands, except par values)
June 30,
2008
|
December 31,
2007
|
||||||
ASSETS
|
|||||||
Current
Assets
|
|||||||
Cash
and cash equivalents
|
$
|
32,924
|
$
|
31,368
|
|||
Short-term
investments
|
5,000
|
-
|
|||||
Collaboration
revenue receivable
|
1,977
|
2,977
|
|||||
Prepaid
clinical study costs
|
-
|
388
|
|||||
Prepaid
insurance
|
486
|
202
|
|||||
Prepaid
expense and other current assets
|
151
|
47
|
|||||
Deferred
income taxes
|
38
|
9,600
|
|||||
Total
current assets
|
40,576
|
44,582
|
|||||
Property,
plant and equipment, net
|
1,123
|
1,046
|
|||||
Total
assets
|
$
|
41,699
|
$
|
45,628
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
Liabilities
|
|||||||
Deferred
program fee revenue – current portion
|
$
|
5,053
|
$
|
21,942
|
|||
Accrued
expenses
|
597
|
334
|
|||||
Total
current liabilities
|
5,650
|
22,276
|
|||||
Non-Current
Liabilities
|
|||||||
Deferred
program fee revenue – non current portion
|
2,105
|
4,632
|
|||||
Total
liabilities
|
7,755
|
26,908
|
|||||
Commitments
and contingencies (Note 9)
|
|||||||
Stockholders’
Equity
|
|||||||
Common
stock - $.01 par value; 650,000 shares authorized; 42,723 and 42,706
shares
issued
and outstanding at June 30, 2008 and December 31, 2007,
respectively
|
427
|
427
|
|||||
Additional
paid-in capital
|
341,058
|
340,153
|
|||||
Accumulated
deficit
|
(307,541
|
)
|
(321,860
|
)
|
|||
Total
stockholders’ equity
|
33,944
|
18,720
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
41,699
|
$
|
45,628
|
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)
For the Six Months
Ended June 30,
|
For the Three Months
Ended June 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Revenue
|
|||||||||||||
Program
fee revenue
|
$
|
22,415
|
$
|
-
|
$
|
8,708
|
$
|
-
|
|||||
Milestone
revenue
|
5,000
|
-
|
5,000
|
-
|
|||||||||
Collaboration
revenue
|
5,354
|
-
|
1,977
|
-
|
|||||||||
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
|
|||||||||
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
|
See
accompanying notes to the consolidated financial statements.
2
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENT OF STOCKHOLDERS' EQUITY
SIX
MONTHS ENDED JUNE 30, 2008
UNAUDITED
(in
thousands, except par values)
Common
Stock
$0.01 Par
Value -
Shares
|
Common
Stock
$0.01 Par
Value -
Amount
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Total
|
||||||||||||
Balance at
December 31, 2007
|
42,706
|
$
|
427
|
$
|
340,153
|
$
|
(321,860
|
)
|
$
|
18,720
|
||||||
Net
income
|
-
|
-
|
-
|
14,319
|
14,319
|
|||||||||||
Stock
based compensation
|
-
|
-
|
885
|
-
|
885
|
|||||||||||
Exercise
of warrant
|
17
|
-
|
20
|
-
|
20
|
|||||||||||
Balance
at June 30, 2008
|
42,723
|
$
|
427
|
$
|
341,058
|
$
|
(307,541
|
)
|
$
|
33,944
|
See
accompanying notes to the consolidated financial statements.
3
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE SIX MONTHS ENDED JUNE 30,
UNAUDITED
(in
thousands, except supplemental disclosures)
|
2008
|
2007
|
|||||
Cash
flows from Operating Activities:
|
|||||||
Net
income (loss)
|
$
|
14,319
|
$
|
(11,358
|
)
|
||
Adjustments
to reconcile net income (loss) to net cash provided by (used in)
operating
activities
|
|||||||
Depreciation
and amortization
|
72
|
61
|
|||||
Amortization
of debt discount
|
-
|
2,102
|
|||||
Loss
on fair value change of conversion features
|
-
|
3,483
|
|||||
Loss
on fair value change of common stock warrants
|
-
|
1,668
|
|||||
Common
stock issued for interest
|
-
|
812
|
|||||
Non-cash
stock compensation expense
|
885
|
722
|
|||||
Gain
on asset disposals
|
(1
|
)
|
(20
|
)
|
|||
Deferred
income taxes
|
9,562
|
-
|
|||||
Impairment
reserve against fixed assets
|
(17
|
)
|
-
|
||||
Changes
in assets and liabilities
|
|||||||
Collaboration
revenue receivable
|
1,000
|
-
|
|||||
Prepaid
expenses and other current assets
|
-
|
60
|
|||||
Accounts
payable
|
-
|
63
|
|||||
Accrued
expenses
|
262
|
188
|
|||||
Deferred
program fee revenue
|
(19,416
|
)
|
-
|
||||
Net
cash provided by (used in) operating activities
|
6,666
|
(2,219
|
)
|
||||
Cash
flows from Investing Activities
|
|||||||
Purchase
of investments
|
(5,000
|
)
|
-
|
||||
Capital
expenditures
|
(131
|
)
|
(29
|
)
|
|||
Proceeds
from asset disposals
|
1
|
20
|
|||||
Net
cash used in investing activities
|
(5,130
|
)
|
(9
|
)
|
|||
Cash
flows from Financing Activities
|
|||||||
Proceeds
from issuance of senior secured term notes payable
|
-
|
2,096
|
|||||
Proceeds
from exercise of stock warrant
|
20
|
-
|
|||||
Payments
on capital lease obligations
|
-
|
(13
|
)
|
||||
Net
cash provided by financing activities
|
20
|
2,083
|
|||||
Increase
(decrease) in cash and cash equivalents
|
1,556
|
(145
|
)
|
||||
Cash
and cash equivalents at beginning of period
|
31,368
|
228
|
|||||
Cash
and cash equivalents at end of period
|
$
|
32,924
|
$
|
83
|
|||
Cash
paid during the period for interest
|
$
|
2
|
$
|
6
|
See
accompanying notes to the consolidated financial statements.
4
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS (CONTINUED)
SUPPLEMENTAL
DISCLOSURES OF NONCASH
INVESTING
AND FINANCING ACTIVITIES
UNAUDITED
(in
thousands, except supplemental disclosures)
Six
Months Ended June 30, 2008
1.
|
Impaired
fixed assets with a $51,000 net book value were disposed and a $17,000
reduction in the impairment allowance was favorably recognized.
|
Six
Months Ended June 30, 2007
1.
|
The
Company issued 47,552 shares of common stock as payment of $460,000
of
Senior Secured Convertible Bridge Term Notes Payable accrued
interest.
|
2.
|
The
Company issued 36,151 shares of common stock as payment of $352,000
of
Secured Term Note Payable accrued
interest.
|
3.
|
Warrants
to purchase an aggregate 58,009 shares of common stock were exercised
at
exercise prices between $1.20 and $6.60 per share in a series of
cashless
exercise transactions resulting in the issuance of an aggregate 31,362
shares of common stock.
|
4.
|
The
issuance of $1,296,000 Senior Secured Convertible Bridge Term Notes
included conversion features measured at $1,188,000, which resulted
in an
equal amount of debt discount. The change in all separated conversion
feature’s fair value through March 30, 2007 resulted in a loss of
$3,483,000. Due to a debt agreement modification on March 30, 2007,
the
then current conversion feature fair value of $21,086,000 was reclassified
from liabilities to equity.
|
5.
|
The
change in the common stock warrants’ fair value through March 30, 2007
resulted in a loss of $1,668,000. Due to a debt agreement modification
on
March 30, 2007, the then current $12,307,000 fair value of all 1,592,100
outstanding common stock warrants was reclassified from liabilities
to
equity, as was $146,000 of such value related to warrants exercised
during
the period.
|
See
accompanying notes to the consolidated financial statements.
5
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
JUNE
30, 2008 AND 2007
NOTE
1 - BASIS OF PRESENTATION
The
accompanying unaudited consolidated financial statements of Acura
Pharmaceuticals, Inc. and subsidiary (the "Company") have been prepared in
accordance with generally accepted accounting principles for interim financial
information and with the instructions to Form 10-Q and Rule 10-01 of Regulation
S-X. Accordingly, they 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, consisting of normal recurring accrual adjustments, considered
necessary to present fairly the financial position as of June 30, 2008 and
results of operations and cash flows for the three months and six months ended
June 30, 2008 have been made. The results of operations for the three and six
month periods ended June 30, 2008 are not necessarily indicative of the results
that may be expected for the full year ending December 31, 2008. The unaudited
consolidated financial statements should be read in conjunction with the
consolidated financial statements and footnotes thereto for the year ended
December 31, 2007 included in the Company's Annual Report on Form 10-K filed
with the Securities and Exchange Commission.
The
year-end consolidated balance sheet was derived from the audited consolidated
financial statements, but does not include all disclosures required by generally
accepted accounting principles. Amounts presented have been rounded to the
nearest thousand, where indicated, except per share data and par values. All
share and per share data have been retroactively adjusted to reflect a
one-for-ten reverse stock split on December 5, 2007.
NOTE
2 –
RESEARCH AND DEVELOPMENT
Research
and Development (“R&D”) expenses include internal R&D activities,
external contract research organization (“CRO”) activities, and other
activities. Internal R&D activity expenses include facility overhead,
equipment and facility maintenance and repairs, depreciation, laboratory
supplies, pre-clinical laboratory experiments, depreciation, salaries, benefits,
and incentive compensation expenses. CRO activity expenses include preclinical
laboratory experiments and clinical trial studies. Other activity expenses
include clinical trial studies, regulatory consulting, regulatory counsel,
and
patent counsel. Internal R&D activities and other activity expenses are
charged to operations as incurred. The Company makes payments to CROs
based on agreed upon terms including payments in advance of the study starting
date. The Company reviews and accrues CRO and clinical trial study expenses
based on work performed and relies on estimates of those costs applicable to
the
stage of completion of a study provided by the CRO. Accrued CRO costs are
subject to revisions as such trials progress to completion. Revisions are
charged to expense in the period in which the facts that give rise to the
revision become known. Advance payments are amortized to expense based on work
performed. The Company has entered into several CRO clinical trial agreements
pursuant to which $0 and $388,000 was prepaid at June 30, 2008 and December
31,
2007, respectively. Unfunded CRO commitments were $2,157,000 and $3,991,000
at
June 30, 2008 and December 31, 2007, respectively and CRO expenses are expected
to be incurred as patients or subjects are enrolled into the clinical studies.
NOTE
3 –
REVENUE RECOGNITION AND DEFERRED PROGRAM FEE REVENUE
We
recognize revenue in accordance with Securities and Exchange Commission Staff
Accounting Bulletin No. 104, “Revenue Recognition in Financial Statements” (“SAB
104”). We have also adopted the provisions of Emerging Issues Task Force, Issue
No. 00-21, “Revenue Arrangements with Multiple Deliverables”
(“EITF 00-21”). Revenue is recognized when there is persuasive evidence
that an arrangement exists, delivery has occurred, the price is fixed and
determinable, and collection is reasonably assured.
6
In
connection with our License, Development and Commercialization Agreement dated
October 30, 2007 (the “King Agreement”) between King Pharmaceuticals Research
and Development, Inc. (“King”) and us, 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 May 2008 upon the exercise of its option
to
license a third opioid analgesic product candidate utilizing our Aversion®
Technology. We have assigned a portion of the King upfront payment to each
of
the 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. Collaboration revenue
is derived from reimbursement of development expenses, which are invoiced
quarterly in arrears, are recognized when costs are incurred pursuant to the
King Agreement. King is obligated to pay us development milestone payments
contingent upon the achievement of certain substantive events in the development
of Acurox™ Tablets and other product candidates licensed to King under the King
Agreement. Milestone payments from King are recognized as revenue upon
achievement of the “at risk” milestone events, which represent the culmination
of the earnings process related to that milestone. Milestone payments are
triggered either by the results of our research and development efforts or
by
events external to us, such as regulatory approval to market a product. As
such,
the milestones are substantially at risk at the inception of the King Agreement,
and the amounts of the payments assigned thereto are commensurate with the
milestone achieved. In addition, upon the achievement of a milestone event,
we
have no future performance obligations related to that milestone payment. Each
milestone payment is non-refundable and non-creditable when made. In
June
2008, King paid us a $5.0 million milestone payment for successfully achieving
the primary endpoints in our pivotal Phase III study, AP-ADF-105 for Acurox™
Tablets. The
ongoing research and development services being provided to King under the
King
Agreement are priced at the Company's cost to provide such services.
NOTE
4 – INCOME TAXES
The
Company accounts for income taxes under the liability method in accordance
with
Statement of Financial Accounting Standards No. 109 ("SFAS No. 109"),
"Accounting for Income Taxes." 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 measured using the enacted
income tax rates and laws that will be in effect when the differences are
expected to reverse. Net operating loss and tax credit carryforwards are
reported as deferred income tax assets and therefore the realization of deferred
income tax assets is dependent upon future earnings. SFAS 109 requires a
valuation allowance 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. The Company has placed a 100%
valuation allowance against its deferred income tax assets.
During
the year ended December 31, 2007, the Company determined it was more likely
than
not that it would be able to realize some of its deferred income tax assets
in
the near future, and recorded a $9.6 million adjustment to the deferred income
tax asset valuation allowance. This adjustment recognized a benefit from income
taxes in our income for such period and provided a current deferred income
tax
asset. During the six months ended June 30, 2008, the Company recorded a tax
provision of $9.6 million and reduced its deferred income tax asset by the
same
amount. 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.
The
Company has determined that Section 382 of the Internal Revenue Code applies
to
the Company’s 2004 equity restructuring events. At June 30, 2008, the Company
had $52 million of Federal net operating loss carryforwards (“NOLS”) which may
be used to offset future taxable income. These NOLs expire between 2009 and
2027. The Company has also determined that as a result of the 2004 equity
restructuring events, $83 million of NOLs incurred prior to the 2004
restructuring events are impaired and currently will not be available to offset
future income. The Company is in the process of seeking a Private Letter Ruling
from the Internal Revenue Service that, if successful, would allow the Company
to utilize some or all of the impaired NOLs in the future.
NOTE
5 – SHARE-BASED COMPENSATION
The
Company has share-based compensation plans including stock options and
restricted stock units for its employees and directors. On January 1, 2006,
the
Company adopted Financial Accounting Standards Board (“FASB”) release FASB
Statement No. 123 (revised 2004), “Share-Based Payment, (“FASB 123R”)”. The
compensation cost relating to share-based payment transactions is now measured
based on the fair value of the equity or liability instruments issued. For
purposes of estimating the fair value of each stock option unit on the date
of
grant, the Company utilized the Black-Scholes option-pricing model. The
Black-Scholes option valuation model was developed for use in estimating the
fair value of traded options, which have no vesting restrictions and are fully
transferable. In addition, option valuation models require the input of highly
subjective assumptions including the expected volatility factor of the market
price of the Company’s common stock (as determined by reviewing its historical
public market closing prices). Because the Company's employee stock options
have
characteristics significantly different from those of traded options and because
changes in the subjective input assumptions can materially affect the fair
value
estimate, in management's opinion, the existing models do not necessarily
provide a reliable single measure of the fair value of its employee stock
options. Included in the six months ended June 30, 2008 and 2007 is $885,000
and
$722,000, respectively, and included in the three months ended June 30, 2008
and
2007 is $764,000 and $280,000, respectively, of share-based compensation
expense.
7
Restricted
Stock Unit Award Plan
The
Company has a Restricted Stock Unit Award Plan (the “2005 RSU Plan”) for its
employees and non-employee directors. A Restricted Stock Unit (“RSU”) represents
the contingent obligation of the Company to deliver a share of its common stock
to the holder of the RSU on a distribution date. RSUs for up to 3.5 million
shares of common stock are authorized for issuance under the 2005 RSU Plan.
Absent
a
change of control, one-fourth of vested shares of common stock underlying an
RSU
award will be distributed (after payment of $0.01 par value per share) on
January 1 of each of 2011, 2012, 2013 and 2014. If a change in control occurs
(whether prior to or after 2011), the vested shares underlying the RSU award
will be distributed at or about the time of the change in control.
In
December 2005, an aggregate of 2.75 million RSUs were granted to the Company’s
employees. In February 2006, an aggregate of 200,000 RSUs were granted to the
Company’s two independent directors. In April 2008, 50,000 RSUs were granted to
a Company employee. Of the 3.0 million RSU awards granted, 2.95 million vested
to the extent of approximately one third upon grant and the other two thirds
using on a straight-line monthly basis through December 2007, with the balance
of 50,000 RSUs vesting at the rate of 2,500 per month through December 2009.
The
weighted average fair value of all RSU grants is $3.49 per share of common
stock
underlying each RSU. Fair value is defined as the market price per share of
the
Company’s common stock on the date of an RSU grant less the exercise cost of
each RSU. The total share-based compensation expense to be incurred by the
Company is the fair value of all RSUs granted. The fair value of the February
2006 RSU grant was $0.7 million which was entirely expensed on the grant date
as
this grant was for performance of past service. The fair value of the December
2005 RSU grant was $9.7 million and was amortized using a graded vesting method
which treated the December 2005 RSU grant as a series of awards rather than
a
single award and attributed a higher percentage of the reported fair value
to
stock-based compensation expense in the earlier years of the vesting schedule
than to the later years. The fair value of the April 2008 RSU grant was $0.4
million. The Company recognized $0.1 million and $0.4 million of share-based
compensation expense from the RSU awards during the six months ended June 30,
2008 and 2007, respectively. As of June 30, 2008, the Company had $370,000
of
unrecognized share-based compensation expense related to the RSUs, which will
be
recognized over the remaining period of 18 months. As of June 30, 2008 and
December 31, 2007, the aggregate intrinsic value of the RSU awards outstanding
and vested was $23.5 million and $18.0 million, respectively.
Stock
Option Plans
The
Company has stock options outstanding under several stock option plans. The
Company’s 1995 Stock Option Plan expired in May 2005 and its 1998 stock Option
Plan expired in April 2008 but options granted under such plans remain
outstanding. On April 30, 2008 the Company's shareholders approved a 2008 Stock
Option Plan authorizing the granting of options to purchase up to 6.0 million
shares of the Company’s common stock.
Stock
options to purchase 3.0 million and 1.9 million shares with a weighted-average
exercise price of $4.94 and $2.54 were outstanding at June 30, 2008 and December
31, 2007, respectively, of which 2.0 million and 1.8 million options were vested
at June 30, 2008 and December 31, 2007, respectively. During the three months
ended June 30, 2008, stock options to purchase an aggregate 90,000 shares having
an exercise price of $6.50 were granted, options to purchase 44,000 shares
expired, and no options were exercised. During the six months ended June 30,
2008, stock options to purchase an aggregate 1.2 million shares having a
weighted average exercise price of $9.58 were granted, options to purchase
49,000 shares expired, and no options were exercised.
As
of
June 30, 2008 the Company had $9.9 million of unrecognized share-based
compensation expense, net of estimated forfeitures, related to stock option
grants, which will be recognized over the remaining weighted average period
of
nine months. Total intrinsic value of stock options outstanding and
exercisable at June 30, 2008 and December 31, 2007 was $11.1 million and $8.1
million, respectively.
8
NOTE
6–
EARNINGS
(LOSS) PER SHARE
The
computation of basic earnings (loss) per share of common stock is based upon
the
weighted average number of both common shares and vested RSUs outstanding during
the period. A RSU represents the contingent obligation of the Company to deliver
a share of its common stock to the holder of a vested RSU on a distribution
date. The computation of diluted earnings (loss) per share is based on the
same
number of both common shares and vested RSUs used in the basic earning (loss)
computation, but adjusted for the effect of other potentially dilutive
securities. Excluded from the diluted earnings (loss) per share computation
at
June 30, 2007 are 7.7 million of potentially dilutive securities, as the effect
of including them would be antidilutive. Accordingly, the loss per share is
the
same result for both basic and diluted computations.
Net
loss
used in the Company’s earnings (loss) per share computations includes the impact
of dividends deemed to have been issued to certain common shareholders as a
result of modifications to debt agreements with those shareholders.
Six
months ended
June
30,
|
Three
months ended
June
30,
|
||||||||||||
(in
thousands, except per share data)
|
2008
|
2007
|
2008
|
2007
|
|||||||||
Basic
earnings (loss) per share
|
|||||||||||||
Numerator:
|
|||||||||||||
Net
income (loss)
|
$
|
14,319
|
$
|
(11,358
|
)
|
$
|
6,870
|
$
|
(2,199
|
)
|
|||
Deemed
dividend from modification of debt
|
-
|
(3
|
)
|
-
|
-
|
||||||||
Net
income (loss) allocable to common shareholder
|
$
|
14,319
|
$
|
(11,361
|
)
|
$
|
6,870
|
$
|
(2,199
|
)
|
|||
Denominator:
|
|||||||||||||
Common
shares (weighted)
|
42,714
|
33,138
|
42,722
|
33,164
|
|||||||||
Vested
restricted stock units (weighted)
|
2,951
|
2,265
|
2,951
|
2,376
|
|||||||||
Weighted
average shares used in computing basic earnings (loss) per share
allocable
to common
shareholder
|
45,665
|
35,403
|
45,673
|
35,540
|
|||||||||
Basic
earnings (loss) per share allocable
to common shareholder
|
$
|
0.31
|
$
|
(0.32
|
)
|
$
|
0.15
|
$
|
(0.06
|
)
|
|||
Diluted
earnings per share
|
|||||||||||||
Denominator:
|
|||||||||||||
Common
shares (weighted)
|
42,714
|
-
|
42,722
|
-
|
|||||||||
Vested
restricted stock units (weighted)
|
2,951
|
-
|
2,951
|
-
|
|||||||||
Stock
options
|
1,746
|
-
|
1,746
|
-
|
|||||||||
Common
stock warrants
|
3,908
|
-
|
3,908
|
-
|
|||||||||
Weighted
average shares used in computing diluted earnings per share allocable
to
common shareholder
|
51,319
|
-
|
51,327
|
-
|
|||||||||
Diluted
earnings (loss) per share allocable to common shareholder
|
$
|
0.28
|
$
|
(0.32
|
)
|
$
|
0.13
|
$
|
(0.06
|
)
|
|||
Excluded
potentially dilutive securities:
|
|||||||||||||
Common
stock issuable (see #1 below):
|
|||||||||||||
Stock
options (vested and nonvested)
|
1,224
|
1,899
|
1,224
|
1,899
|
|||||||||
Nonvested
restricted stock units
|
45
|
492
|
45
|
492
|
|||||||||
Common
stock warrants
|
47
|
1,575
|
47
|
1,575
|
|||||||||
Convertible
bridge term notes
|
-
|
3,770
|
-
|
3,770
|
|||||||||
Total
excluded dilutive common stock equivalents
|
1,316
|
7,736
|
1,316
|
7,736
|
(1)
Number of common shares issuable is based on maximum number of common shares
issuable on exercise or conversion of the related securities as of period end.
Such amounts have not been adjusted for the treasury stock method or weighted
average outstanding calculations required if the securities were
dilutive.
9
NOTE
7 – ACCRUED EXPENSES
Accrued
expenses are summarized as follows (in thousands):
Jun
30,
|
Dec
31,
|
||||||
2008
|
2007
|
||||||
Payroll,
payroll taxes and benefits
|
$
|
132
|
$
|
63
|
|||
Legal
fees
|
57
|
35
|
|||||
Audit
examination and tax preparation fees
|
87
|
120
|
|||||
Franchise
taxes
|
23
|
15
|
|||||
Property
taxes
|
43
|
34
|
|||||
Clinical,
regulatory, trademarks, and patent consulting fees
|
233
|
50
|
|||||
Other
fees and services
|
22
|
17
|
|||||
$
|
597
|
$
|
334
|
NOTE
8 – COMMON STOCK WARRANTS
At
June
30, 2008, the Company had outstanding common stock purchase warrants,
exercisable for an aggregate of approximately 3,955,000 shares of common stock,
all of which contain cashless exercise features. A warrant for 17,000 shares
of
common stock was exercised at a cash exercise price of $1.20 per share during
the six month period month period ended June 30, 2008. During the six months
ended June 30, 2007, warrants to purchase aggregate 58,009 shares of common
stock were exercised at exercise prices between $1.20 and $6.60 per share in
a
series of cashless exercise transactions resulting in the issuance of aggregate
31,362 shares of common stock. At June 30, 2008, outstanding common stock
purchase warrants of 47,000, 409,000, 64,000 and 3,435,000 will expire if
unexercised during the 2008, 2009, 2010 and years thereafter, respectively,
and
have a weighted average remaining term of 5.3 years. The exercise prices of
these warrants range from $1.29 to $9.90 per share, with a weighted average
exercise price of $3.25.
NOTE
9 – COMMITMENTS AND CONTINGENCIES
Employment
Agreements
Robert
B.
Jones commenced employment with us on April 7, 2008 pursuant to an employment
agreement dated March 18, 2008 which provides that Mr. Jones will serve as
our
Senior Vice President and Chief Operating Officer for a term expiring December
31, 2009. The term of the employment agreement provides for automatic one (1)
year renewals in the absence of written notice to the contrary from us or Mr.
Jones at least ninety (90) days prior to the expiration of the initial term
or
any subsequent renewal period. Mr. Jones’ annual base salary under the
employment agreement is $290,000. The employment agreement provides that Mr.
Jones is eligible for annual bonuses of up to thirty percent (30%) of his base
salary on the achievement of such targets, conditions, or parameters as may
be
set from time to time by the Board of Directors or the Compensation Committee
of
the Board of Directors. The employment agreement further provides for our grant
to Mr. Jones of stock options exercisable for 30,000 shares of common stock
at
an exercise price of $8.64 which was the closing stock price of the Company’s
common stock on the NASDAQ at April 4, 2008. The stock option provides for
vesting of 1,500 shares on the last day of each month commencing May 31, 2008.
The employment agreement also provides for the grant to Mr. Jones of a
restricted stock unit award of 50,000 shares of our common stock. The restricted
stock unit vests 2,500 shares on the last day of each month commencing May
31,
2008.
The
employment agreement of Ron Spivey, Senior Vice President and Chief Scientific
Officer was amended to provide that Dr. Spivey will receive a $315,000 bonus
payment (in addition to any other payments to which he may be entitled pursuant
to the Executive Employment Agreement) if he remains employed by us through
December 31, 2008. The bonus payment will also be payable if Dr. Spivey’s
employment is terminated by us without Cause (as defined in his Executive
Employment Agreement) or if he terminates his employment for Good Reason (as
defined in his Executive Employment Agreement) prior to December 31, 2008.
The
bonus payment will be paid on December 31, 2008. In addition, as part of the
amendment to Dr. Spivey’s Executive Employment Agreement, we entered into an
Amended and Restated Employment Agreement to be effective January 1, 2009.
The
Amended and Restated Employment Agreement provides that commencing January
1,
2009, Dr. Spivey will continue his employment with us through December 31,
2010
on a part-time basis (10 weeks per year) at an annual salary of $120,000 and
will have the title of Senior Scientific Advisor. Dr. Spivey will report to
the
Chief Executive Officer and will be eligible for benefits offered to part-time
employees.
10
The
employment agreements of Andrew D. Reddick, President and Chief Executive
Officer and Peter A. Clemens, Senior Vice President and Chief Executive Officer,
which automatically renew annually unless a party provides the other party
a
notice of non-renewal, were amended to provide that the expiration of the
agreements due to our non-renewal constitutes a termination without Cause (as
defined in the respective agreements) and our providing of a notice of
non-renewal will permit Messrs. Reddick and Clemens to terminate their
respective agreements for Good Reason (as defined in such agreements). A
termination without Cause or a termination for Good Reason will, among other
things, trigger severance and bonus payments under the respective
agreements.
Financial
Advisor Agreement
In
connection with the Company’s August 2007 Unit Offering, the Company is
obligated to pay a fee to the Company’s financial advisor upon each exercise of
the warrants issued in the Unit Offering, in proportion to the number of
warrants exercised. The maximum amount of such fee assuming 100% exercise of
such warrants is $255,000. The Company has not reflected this obligation as
a
liability in its unaudited financial statements as the payment is contingent
upon the timing and exercise of the warrants by each of the warrant holders.
Such fee, if any, will be paid and charged against earnings as and if the
warrants are exercised. No warrants have been exercised under the August 2007
Unit Offering.
NOTE
10 – RECENT EVENTS
King
Agreement
In
December, 2007, the Company and King Pharmaceuticals Research and Development,
Inc. (“King”), a wholly-owned subsidiary of King Pharmaceuticals, Inc., closed a
License, Development and Commercialization Agreement (the “King Agreement”) to
develop and commercialize in the United States, Canada and Mexico (the
"Territory") certain opioid analgesic products utilizing the Company's
proprietary Aversion® (abuse deterrent) Technology including Acurox™ Tablets.
The King Agreement provides King with an exclusive license in the Territory
for
Acurox™ Tablets and another undisclosed opioid analgesic product candidate
utilizing Acura's Aversion® Technology. In addition, the King Agreement provides
King with an option to license in the Territory all future opioid analgesic
products developed utilizing Acura's Aversion® Technology.
Under
the
terms of the King Agreement, King made an upfront cash payment to Acura of
$30
million in December 2007. In May 2008 King paid us a $3.0 million option
exercise fee upon King’s exercise of its option to license a third opioid
analgesic product utilizing our Aversion® Technology. In addition, in June 2008,
King paid us a $5.0 million milestone payment relating to the successful
achievement of the primary endpoints for our pivotal Phase III study for Acurox®
Tablets. Depending on the achievement of certain regulatory milestones, King
could also make additional cash payments to Acura of up to $23 million relating
to Acurox™ Tablets and similar amounts with respect to each additional Aversion®
Technology product developed under the King Agreement. King will reimburse
Acura
for all research and development expenses incurred beginning from September
19,
2007 for Acurox™ Tablets and all research and development expenses related to
future products after King's exercise of its option to an exclusive license
for
each future product. King will record net sales of all products. Commencing
one
year after the first commercial sale of the first product commercialized, King
will pay us a royalty ranging from 5% to 25% based on the level of combined
annual net sales for all products commercialized subject to the King Agreement.
King will also make a one-time cash payment to us of $50 million in the first
year in which the combined annual net sales of all products exceed $750
million.
Pursuant
to the King Agreement, King and Acura have formed a joint steering committee
to
coordinate development and commercialization strategies. With King’s oversight,
Acura will conduct all Acurox™ Tablet development activities through approval of
a New Drug Application (“NDA”) and thereafter King will commercialize Acurox™ in
the U.S. With respect to all other products subject to the King Agreement,
King
will be responsible for development and regulatory activities following either
acceptance of an Investigational New Drug Application by the U.S. Food and
Drug
Administration (“FDA”) or Acura's demonstration of certain stability and
pharmacokinetic characteristics for each future product candidate. All products
developed pursuant to the King Agreement will be manufactured by King or a
third
party contract manufacturer under the direction of King. Subject to the King
Agreement, King will have final decision making authority with respect to all
development and commercialization activities for all products
licensed.
11
In
May
2008, we announced that King exercised its option to license a third
immediate-release opioid analgesic product utilizing Acura’s proprietary
Aversion® Technology. In June 2008, we announced that clinical evaluation is
allowed under an active Investigational New Drug application (“IND”) for a
second undisclosed opioid analgesic product candidate using Aversion®
Technology. Both of these product candidates are licensed to King and are being
developed under the auspices of a joint steering committee.
In
June
2008, we announced positive top-line results from our pivotal Phase III study,
AP-ADF-105 (“Study 105”). Both strengths of Acurox™ Tablets met the primary pain
relief endpoint compared to placebo (p=.0001, and p<.0001). The most
prevalent reported adverse events in patients receiving Acurox™ Tablets were
nausea, vomiting, dizziness, pruritis and flushing. Study 105 was conducted
under the U.S. Food and Drug Administration (“FDA”) Special Protocol Assessment
(“SPA”) provision.
The
foregoing description of the Agreement contains forward-looking statements
about
Acurox™ Tablets and other products developed 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 the
Company by King will materialize. For further discussion of other risks and
uncertainties associated with the Company, see Item 1A in Part II in this Report
and our Annual Report on Form 10-K for the year ended December 31, 2007, under
the heading “Risks Factors”.
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 that
may
occur 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 (to whom we have licensed our Aversion Technology for certain opioid
Analgesic products in the United States, Canada and Mexico) and the ability
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 this Report. When used
in this Report, the words "estimate," "project," "anticipate," "expect,"
"intend," "believe," and similar expressions are intended to identify
forward-looking statements.
12
Company
Overview
We
are a
specialty pharmaceutical company engaged in research, development and
manufacture of innovative Aversion® Technology and related product candidates.
Product candidates developed with Aversion® Technology and containing opioid
analgesic active ingredients are intended to effectively relieve pain and also
discourage the most common methods of pharmaceutical product misuse and abuse
including; (i) intravenous injection of dissolved tablets or capsules, (ii)
nasal snorting of crushed tablets or capsules and (iii) intentional swallowing
of excessive numbers of tablets or capsules. Acurox™ Tablets, our lead product
candidate utilizing Aversion® Technology, is being developed pursuant to an
active investigational new drug application (“IND”) on file with the U.S. Food
and Drug Administration (“FDA”). Aversion® Technology is our patented platform
technology for developing pharmaceutical products containing potentially
abuseable drugs including oxycodone, hydrocodone, oxymorphone, hydromorphone,
morphine, codeine, tramadol, propoxyphene, and many others. Additional Aversion®
Technology patents are pending encompassing a wide range of abuseable drugs
including stimulants, tranquilizers and sedatives. Aversion® Technology is
applicable to orally administered tablets and capsules. In addition to the
active ingredient, Aversion® Technology utilizes certain patented compositions
of pharmaceutical product inactive and active ingredients intended to discourage
or deter pharmaceutical product abuse.
Status
of Patent Applications, Patent Publications, and Issued
Patents
In
April
2007, the United States Patent and Trademark Office (the “USPTO”), issued to us
U.S. Patent No. 7,201,920 titled “Methods and Compositions for Deterring Abuse
of Opioid Containing Dosage Forms”. The 54 allowed patent claims encompass
pharmaceutical compositions intended to reduce or discourage the most common
methods of prescription opioid analgesic product misuse and abuse. The opioid
analgesics in the issued patent claims include oxycodone, hydrocodone,
hydromorphone, morphine, codeine, tramadol, propoxyphene and many others.
In
June
2008, the USPTO issued to the Company a Notice of Allowance for a
non-provisional patent application titled “Methods and Compositions for
Deterring Abuse of Opioid Containing Dosage Forms” (the “122
Application”). After further review of one of the 21 claims discussed in
the Notice of Allowance and after consideration of a potential interference
proceeding relating to a third party patent application containing a similar
claim, we filed with the USPTO a Request for Continued Examination relating
to
the 122 Application and simultaneously cancelled one of the 21 allowed claims.
Although no assurance can be given, based on the USPTO’s prior review of the 122
Application, we expect that a Notice of Allowance for the remaining 20 claims
included in the 122 Application will be granted by the USPTO in the coming
months. The 20 claims included in our amended 122 Application are intended
to
enhance and broaden the patent coverage provided by the 54 issued claims in
the
Company's first patent relating to deterring abuse of opioids.
In
addition to issued U.S. Patent No. 7,201,920, as of the date of this report,
we
have five U.S. non-provisional pending patent applications, three WO/PCT pending
patent applications and multiple additional U.S. provisional and international
patent filings relating to compositions containing abuseable drugs.
As
of the
date of this report, except for those rights conferred in the King Agreement,
we
have retained all of the intellectual property rights to our Aversion®
Technology and related product candidates.
Reference
is made to Part II, “Item 1A. Risk Factors Relating to the Company” for a
discussion, among other things, of pending patent applications owned by third
parties which have claims that encompass our Acurox® Tablets product candidate
and the Aversion® Technology. If such third party patent applications result in
valid and enforceable issued patents containing claims in their current firm,
we
or our licensees could be required to obtain a license to such patents, should
one be available, or alternatively, to alter the Aversion® Technology so as to
avoid infringing such third-party patents.
13
Company’s
Present Financial Condition
At
July
29, 2008, we had cash and cash equivalents of approximately $37.0 million.
We
estimate that our current cash reserves will be sufficient to fund operations
and the development of Aversion® Technology and related product candidates
through at least the next 12 months.
As
described in Note 10 - Recent Events, in December, 2007, we and King closed
a
License, Development and Commercialization Agreement (the “King Agreement”) to
develop and commercialize certain opioid analgesic products utilizing our
proprietary Aversion® Technology in the United States, Canada and Mexico. During
the six months ended June 30, 2008, we recognized revenues of $19.4 million
of
the $30.0 million upfront cash payment received from King in December 2007,
recognized a $3.0 million option exercise fee paid to us by King upon the
exercise of its option to license a third opioid analgesic product candidate,
recognized a $5.0 million Acurox™ tablet development milestone received from
King, and recognized revenues for reimbursement by King of our Acurox™ tablet
development expenses. We have yet to generate any royalty revenues from product
sales. We expect to rely on our current cash resources and additional payments
that may be made under the King Agreement and under similar license agreements
with other pharmaceutical company partners, of which there can be no assurance,
in funding our continued operations. Our cash requirements for operating
activities may increase in the future as we continue to conduct pre-clinical
studies and clinical trials for our product candidates, maintain, defend, if
necessary and expand the scope of our intellectual property, hire additional
personnel, or invest in other areas.
Results
of Operations for the Six Months Ended June 30, 2008 and June 30,
2007
Revenue
Six Months Ended June 30,
|
Change
|
||||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Revenue
– Program fee revenue
|
$
|
22,415
|
$
|
-
|
$
|
22,415
|
*
|
%
|
King
paid
us a $30.0 million upfront fee in connection with the closing of the King
Agreement in December 2007. Program fee revenue recognized for the six months
ended June 30, 2008 from amortization of this upfront fee was $19.4 million.
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 to extend through
November, 2009. Also, included in program fee revenue is a $3.0 million option
exercise fee paid by King to us in May 2008 upon the exercise of its option
to
license a third opioid analgesic product candidate under the King Agreement.
The
Company had no program fee revenue for the six months ended June 30, 2007.
|
Six Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Revenue
– Milestone revenue
|
$
|
5,000
|
$
|
-
|
$
|
5,000
|
*
|
%
|
In
June
2008, King paid us a $5.0 million milestone payment for successfully achieving
the primary end points in our pivotal Phase III study, AP-ADF-105 for
Acurox™ Tablets. The Company had no milestone revenue for the six months ended
June 30, 2007.
|
Six Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Revenue
– Collaboration fee revenue
|
$
|
5,354
|
$
|
-
|
$
|
5,354
|
*
|
%
|
Collaboration
revenue recognized for the six months ended June 30, 2008 was $5.4 million
for
billed reimbursement of our Acurox™ Tablets development expenses incurred
pursuant to the King Agreement from January 1, 2008 to June 30, 2008. We invoice
King in arrears on a calendar quarter basis for our Acurox™ tablet development
expenses under the King Agreement. We expect the amount and timing of
collaboration revenue to fluctuate in relation to the amount and timing of
the
underlying research and development expenses. The Company had no collaboration
revenue for the six months ended June 30, 2007.
Operating
Expenses
|
Six Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Research
and development expenses
|
$
|
7,166
|
$
|
1,948
|
$
|
5,218
|
268
|
%
|
14
Research
and development expense during the six months ended June 30, 2008 and 2007
were
for product candidates utilizing our Aversion®
Technology, 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 2008 and 2007 results are non-cash
stock-based compensation charges of $177 and $293, respectively. Excluding
the
stock-based compensation expense, there is a $5,334 increase in development
expenses primarily attributable to increasing clinical study costs.
|
Six Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Marketing,
general & administrative expenses
|
$
|
2,244
|
$
|
1,366
|
$
|
878
|
64
|
%
|
During
the six months ended June 30, 2008 and 2007, marketing expenses consisted of
Aversion®
Technology primary market research studies. Our general and administrative
expenses primarily consisted of legal, audit and other professional fees,
corporate insurance, and payroll costs. Included in the 2008 and 2007 results
are non-cash stock-based compensation charges of $708 and $429, respectively.
Excluding the stock-based compensation expense, the expenses increased $599
attributable to general legal counsel costs and shareholders’ communication
costs associated with the company’s annual shareholders’ meeting.
Other
Income (Expense)
|
Six Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
|
%
|
||||||||
Interest
income (expense), net
|
$
|
504
|
$
|
(809
|
)
|
$
|
1,313
|
162
|
%
|
Through
August 19, 2007 we incurred interest expense on our $5.0 million Secured Term
Note at a variable interest rate of prime plus 4.5% per annum and thereafter
at
a fixed interest rate of 10.0% per annum. Interest expense on our $5.0 million
Secured Term Note was payable in our common stock through August 19, 2007 and
thereafter in cash. Beginning August 20, 2007 such cash interest was deferred
until we fully repaid such note on December 7, 2007. In 2007, we also incurred
interest expense on our $10.544 million Senior Secured Convertible Bridge Notes
(collectively, the “Bridge Loans”) at the fixed rate of 10.0%. Interest on such
Bridge Loans was paid in our common stock. On August 20, 2007, the entire
$10.544 million principal amount of the Bridge Loans was converted into Units
consisting of our common stock and warrants in accordance with our Unit
Offering. During the six months ended June 20, 2008, the cash proceeds received
pursuant to the King Agreement were primarily invested in bank commercial paper
with maturity dates less than 12 months, resulting in interest income of
$504.
Net
Income (Loss)
|
Six Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Net
income (loss)
|
$
|
14,319
|
$
|
(11,358
|
)
|
$
|
25,677
|
226
|
%
|
The
Company’s net income for the six months ended June 30, 2008 includes a provision
for an income tax expense of $9.6 million. The Company anticipates the
utilization of its deferred tax assets to offset income taxes payable and has
reflected such expectation in our June 30, 2008 Balance Sheet.
The
Company’s net loss for the six months ended June 30, 2007 includes a)
debt
discount amortization expense of $2.1 million arising from values assigned
to
conversion features on issuances of bridge loans, b) $3.5 million loss on fair
value changes to amended conversion features on bridge loans being accounted
for
as mark-to-market liabilities and c) $1.7 million loss on fair value changes
to
common stock warrants being accounted for as mark-to-market liabilities and
(d)
$4.1 million is operating and other losses.
Results
of Operations for the Three Months Ended June 30, 2008 and June 30,
2007
Revenue
|
Three Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Revenue
– Program fee revenue
|
$
|
8,708
|
$
|
-
|
$
|
8,708
|
*
|
%
|
15
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 June
30, 2008 from amortization of this upfront fee was $5.7 million. 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 to extend through
November, 2009. Included in program fee revenue is a $3.0 million option
exercise fee paid by King to us in May 2008 upon the exercise of its option
to
license a third opioid analgesic product candidate under the King Agreement.
The
Company had no program fee revenue for the three months ended June 30, 2007.
|
Three Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Revenue
– Milestone revenue
|
$
|
5,000
|
$
|
-
|
$
|
5,000
|
*
|
%
|
In
June
2008, King paid us a $5.0 million milestone payment for successfully achieving
the primary end points in our pivotal Phase III study, AP-ADF-105 for
Acurox™ Tablets. The Company had no milestone revenue for the three months ended
June 30, 2007.
|
Three Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Revenue
– Collaboration fee revenue
|
$
|
1,977
|
$
|
-
|
$
|
1,977
|
*
|
%
|
Collaboration
revenue recognized in the three months ended June 30, 2008 was $2.0 million
for
billed reimbursement of our Acurox™ tablet development expenses incurred
pursuant to the King Agreement from April 1, 2008 to June 30, 2008. We invoice
King in arrears on a calendar quarter basis for our Acurox™ tablet development
expenses under the King Agreement. We expect the amount and timing of
collaboration revenue to fluctuate in relation to the amount and timing of
the
underlying research and development expenses. The Company had no collaboration
revenue for the three months ended June 30, 2007.
Operating
Expenses
|
Three Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Research
and development expenses
|
$
|
3,084
|
$
|
752
|
$
|
2,332
|
310
|
%
|
Research
and development expense during the three months ended June 30, 2008 and 2007
were for product candidates utilizing our Aversion®
Technology, 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 2008 and 2007 results are non-cash
stock-based compensation charges of $175 and $114, respectively. Excluding
the
stock-based compensation expense, there is a $2,908 increase in development
expenses primarily attributable to increasing clinical study costs.
|
Three Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Marketing,
general & administrative expenses
|
$
|
1,374
|
$
|
588
|
$
|
786
|
134
|
%
|
During
the three months ended June 30, 2008 and 2007, marketing expenses consisted
of
Aversion®
Technology primary market research studies. Our general and administrative
expenses primarily consisted of legal, audit and other professional fees,
corporate insurance, and payroll costs. Included in the 2008 and 2007 results
are non-cash stock-based compensation charges of $589 and $166, respectively.
Other
Income (Expense)
|
Three Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Interest
income (expense), net
|
$
|
207
|
$
|
(447
|
)
|
$
|
654
|
146
|
%
|
Through
August 19, 2007 we incurred interest expense on our $5.0 million Secured Term
Note at a variable an interest rate of prime plus 4.5% per annum and thereafter
at a fixed interest rate of 10.0% per annum. Interest expense on our $5.0
million Secured Term Note was payable in our common stock through August 19,
2007 and thereafter in cash. Beginning August 20, 2007 such cash interest was
deferred until we fully repaid such note on December 7, 2007. In 2007, we also
incurred interest expense on our $10.544 million Senior Secured Convertible
Bridge Notes (collectively, the “Bridge Loans”) at the fixed rate of 10.0%.
Interest on such Bridge Loans was paid in our common stock. On August 20, 2007,
the entire $10.544 million principal amount of the Bridge Loans was converted
into Units consisting of our common stock and warrants in accordance with our
Unit Offering. During the three months ended June 30, 2008, the cash proceeds
received pursuant to the King Agreement were primarily invested in bank
commercial paper with maturity dates less than 12 months resulting in interest
income of $207.
16
Net
income (Loss)
|
Three Months Ended June 30,
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
2007
|
Dollars
|
%
|
|||||||||
Net
income (loss)
|
$
|
6,870
|
$
|
(2,199
|
)
|
$
|
9,069
|
412
|
%
|
The
Company’s net income for the three months ended June 30, 2008 includes a
provision for income tax expense of $5.0 million. The Company anticipates the
utilization of its deferred tax assets to offset incomes taxes payable and
has
reflected such expectation in our June 30, 2008 Balance Sheet.
The
Company’s net loss for the three months ended June 30, 2007 includes
debt
discount amortization expense of $0.4 million arising from values assigned
to
conversion features on issuances of Bridge Loans and $1.8 million in operating
and other losses.
Liquidity
and Capital Resources
At
June
30, 2008, the Company had unrestricted cash, cash equivalents ands short-term
investments of $38.0 million
compared to $31.4 million in aggregate cash and cash equivalents at December
31,
2007. The Company had working capital of $34.9 million at June 30, 2008 compared
to $22.3 million at December 31, 2007. The increase in our cash position of
$6.6
million is primarily due to our receipt from King of a $3.0 million option
exercise fee and a $5.0 million milestone payment. The increase in working
capital of $12.6 million is primarily due to the recognition of a portion of
the
deferred program fee revenue offset by the utilization of our deferred tax
assets against our recorded income tax provision and our receipt of the option
exercise fee and milestone payment described above. Cash flows generated in
operating activities were $6.7 million for the six month period June 30, 2008
primarily representing recognition of deferred program fee revenue offset by
our
utilization of net deferred tax assets, non-cash charges for stock compensation,
and our net income for the 2008 period. Cash flow used in operating activities
for the six month period June 30, 2007 primarily represented our net losses
for
the period less non-cash charges related to amortization of debt discount,
fair
value changes of conversion features and common stock warrants, stock
compensation and common stock issued for interest. Capital expenditures of
$0.1
million and our purchase of short-term investments of $5.0 million were our
financing activities for the 2008 period. Capital expenditures offset by
proceeds from asset disposal include cash flows used in investing activities
for
the 2007 period was less than ten thousand dollars. The cash exercise of a
warrant for twenty thousand dollars constituted our financing activities for
the
2008 period. Our financing activities of $1.3 million for the 2007 six month
period related primarily to additional bridge loan borrowings.
At
July
29, 2008, the Company had cash, cash equivalents, and short-term investments
of
approximately $37.0 million. The Company estimates that such cash reserves
will
be sufficient to fund the development of the Aversion® Technology and related
operating expenses at least through the next 12 months.
The
following table presents the Company's expected cash requirements for
contractual obligations outstanding as of June 30, 2008 (in
thousands):
Expected
cash payments on
contractual
obligations outstanding
at
June 30, 2008
|
Total
|
Due
in
2008
|
Due
in
2009
|
Due
Thereafter
|
|||||||||
Clinical
trials
|
$
|
2,157
|
$
|
2,157
|
$
|
-
|
$
|
-
|
|||||
Operating
leases
|
22
|
15
|
7
|
-
|
|||||||||
Employment
agreements
|
878
|
588
|
290
|
-
|
|||||||||
Marketing
study
|
18
|
18
|
-
|
-
|
|||||||||
Total
contractual cash obligations
|
$
|
3,075
|
$
|
2,778
|
$
|
297
|
$
|
-
|
|||||
Expected
cash payments on
contractual
obligations entered into
subsequent
to June 30, 2008
|
Total
|
|
|
Due
in
2008
|
|
|
Due
in
2009
|
|
|
Due
Thereafter
|
|||
Clinical
trials
|
$
|
283
|
$
|
283
|
$
|
-
|
$
|
-
|
17
Critical
Accounting Policies
Note
A of
the Notes to Consolidated Financial Statements, in the Company’s 2007 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 does not believe there is a
consequential likelihood that materially different amounts would be reported
under different conditions or using different assumptions. The Company's
critical accounting policies described in the 2007 Annual Report are also
applicable to 2008.
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
second fiscal quarter of 2008 that have materially affected, or are reasonably
likely to materially affect, our internal controls over financial
reporting.
PART
II
Item
1A.
Risk Factors Relating To The Company
In
addition to the Risk Factors set forth in Item 1A of the Company’s Annual Report
on Form 10-K for the year ended December 31, 2007, shareholders and prospective
investors in the Company’s common stock should carefully consider the following
risk factor. The risk factor provided below updates the risk factor having
the
same caption description in our 2007 Form 10-K.
We
May Become Involved in Patent Litigation or Other Intellectual Property
Proceedings Relating to Our Aversion® Technology or Product Candidates Which
Could Result in Liability for Damages or Delay or Stop Our Development and
Commercialization Efforts
The
pharmaceutical industry has been characterized by significant litigation and
other proceedings regarding patents, patent applications and other intellectual
property rights. The situations in which we may become parties to such
litigation or proceedings may include:
·
|
litigation
or other proceedings we may initiate against third parties to enforce
our
patent rights or other intellectual property rights;
|
·
|
litigation
or other proceedings we may initiate against third parties to seek
to
invalidate the patents held by such third parties or to obtain a
judgment
that our product candidates do not infringe such third parties’
patents;
|
·
|
litigation
or other proceedings third parties may initiate against us to seek
to
invalidate our patents or to obtain a judgment that third party products
do not infringe our patents;
|
18
·
|
if
our competitors file patent applications that claim technology also
claimed by us, we may participate in interference or opposition
proceedings to determine the priority of invention; and
|
·
|
if
third parties initiate litigation claiming that our product candidates
infringe their patent or other intellectual property rights, we will
need
to defend against such proceedings.
|
Our
failure to avoid infringing third-party patents and intellectual property rights
in the commercialization of products utilizing the Aversion® Technology will
have a material adverse affect on our operations and financial
condition.
The
costs
of resolving any patent litigation or other intellectual property proceeding,
even if resolved in our favor, could be substantial. Most of our competitors
will be able to sustain the cost of such litigation and proceedings more
effectively than we can because of their substantially greater resources.
Uncertainties resulting from the initiation and continuation of patent
litigation or other intellectual property proceedings could have a material
adverse effect on our ability to compete in the marketplace. Patent litigation
and other intellectual property proceedings may also consume significant
management time.
Our
Aversion® Technology may be found to infringe upon claims of patents owned by
others. If we determine or if we are found to be infringing on a patent held
by
another, we or our licensees might have to seek a license to make, use, and
sell
the patented technologies. In that case, we or our licensees might not be able
to obtain such license on acceptable terms, or at all. The failure to obtain
a
license to any technology that may be required would materially harm our
business, financial condition and results of operations. If a legal action
is
brought against us, we could incur substantial defense costs, and any such
action might not be resolved in our favor. If such a dispute is resolved against
us, we may have to pay the other party large sums of money and our use of our
Aversion® Technology and the testing, manufacturing, marketing or sale of one or
more of our products could be restricted or prohibited. Even prior to resolution
of such a dispute, use of our Aversion® Technology and the testing,
manufacturing, marketing or sale of one or more of our products could be
restricted or prohibited.
Moreover,
other parties could have blocking patent rights to products made using the
Aversion® Technology. We are aware of certain United States and international
pending patent applications owned by third parties claiming abuse deterrent
technologies, including at least two pending patent applications which have
claims that encompass our lead product candidate or the Aversion® Technology.
While we do not expect that the claims contained in such two pending patent
applications will issue in their present form, there can be no assurance in
this
regard. If such patent applications result in valid and enforceable issued
patents containing claims in their current form we or our licensees could be
required to obtain a license to such patents, should one be available, or
alternatively to alter the Aversion® Technology so as to avoid infringing such
third-party patents. If we or our licensees are unable to obtain a license
on
commercially reasonable terms, or at all, we or our licensees could be
restricted or prevented from commercializing products utilizing the Aversion®
Technology. Additionally, any alterations to the Aversion® Technology in view of
third-party patent applications or issued patents could be time consuming and
costly and may not result in technologies or products that are non-infringing
or
commercially viable. We cannot assure that our products and/or actions in
developing products incorporating our Aversion® Technology will not infringe
third-party patents.
The
Company's 2008 Annual Meeting of Shareholders was held on April 30, 2008 (the
“Annual Meeting”). In connection with the Annual Meeting proxies were solicited
by management pursuant to Regulation 14A under the Securities Exchange Act
of
1934, as amended. On the record date for the Annual Meeting, the Company's
outstanding voting securities consisted of 42,706,466 shares of common stock,
of
which 39,641,124 shares were represented in person or by proxy at the Annual
Meeting. At the Annual Meeting, the following matters were submitted to a vote
of the Company's voting security holders, with the results indicated
below:
1.
Election of Directors: The following seven (7) incumbent directors were elected
to serve until the next Annual Meeting of Shareholders. The tabulation of votes
was as follows:
Nominee
|
For
|
Withheld
|
|||||
Richard
J. Markham
|
|
|
39,409,482
|
|
|
231,632
|
|
Immanuel
Thangaraj
|
|
|
39,407,132
|
|
|
233,982
|
|
Bruce
F. Wesson
|
|
|
39,409,165
|
|
|
231,949
|
|
Andrew
D. Reddick
|
|
|
39,416,216
|
|
|
224,898
|
|
William
A. Sumner
|
|
|
39,434,258
|
|
|
206,289
|
|
William
G. Skelly
|
|
|
39,434,825
|
|
|
206,289
|
|
George
Ross
|
39,434,918
|
206,196
|
19
2.
Proposal to ratify the adoption of the Company’s 2008 Stock Option Plan.
The tabulation of votes was as follows:
For
|
|
Against
|
|
Abstained
|
|
Not
Voted
|
|
|||
34,764,832
|
|
|
227,814
|
|
|
15,748
|
|
|
4,632,720
|
|
3.
Proposal to ratify the amendment to the Company’s 2005 Restricted Stock Unit
Award Plan. The tabulation of votes was as follows:
For
|
|
Against
|
|
Abstained
|
|
Not
Voted
|
|
|||
34,780,914
|
|
|
216,791
|
|
|
10,759
|
|
|
4,632,720
|
|
4.
Proposal to Ratify the Company’s independent registered public accounting firm
for the current fiscal year.
The
tabulation of votes was as follows:
For
|
|
Against
|
|
Abstained
|
|
Not
Voted
|
|
|||
|
|
16,909
|
|
|
26,741
|
|
|
0
|
|
Item
6. Exhibits
The
exhibits required to be filed as part of this Report 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.
|
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.
|
20
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.
July
29, 2008
|
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
|
21