ACURA PHARMACEUTICALS, INC - Quarter Report: 2007 March (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 March 31, 2007
or
¨
|
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
|
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 (or for such shorter period that the registrant was required
to file such reports), 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 an accelerated filer (as defined in
Rule
12b-2 of the Exchange Act).
Yes
o
No
þ
As
of May
2, 2007 the registrant had 331,685,842 shares of Common Stock, $.01 par value,
outstanding.
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
|
||
INDEX
|
||
PART
1. FINANCIAL INFORMATION
|
||
Page
|
||
Item
1.
|
Financial
Statements (Unaudited)
|
2
|
Consolidated
Balance Sheets
|
||
March
31, 2007 and December 31, 2006
|
2
|
|
Consolidated
Statements of Operations
|
||
Three
months ended March 31, 2007 and March 31, 2006
|
3
|
|
Consolidated
Statement of Stockholders’ Deficit
|
||
Three
months ended March 31, 2007
|
4
|
|
Consolidated
Statements of Cash Flows
|
||
Three
months ended March 31, 2007 and March 31, 2006
|
5
|
|
Notes
to Consolidated Financial Statements
|
7
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
14
|
Item
4.
|
Controls
and Procedures
|
27
|
PART
II. OTHER INFORMATION
|
||
Item
1A.
|
Risk
Factors Relating to the Company
|
27
|
Item
2.
|
Unregistered
Sale of Equity Securities and Use of Proceeds
|
27
|
Item
6.
|
Exhibits
|
28
|
Signatures
|
28
|
PART
I. FINANCIAL INFORMATION
Item
1. Financial
Statements
|
|||||||
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
|
|||||||
CONSOLIDATED
BALANCE SHEETS
|
|||||||
UNAUDITED
|
|||||||
(in
thousands, except par values)
|
|||||||
March
31,
|
|
December
31,
|
|
||||
|
|
2007
|
|
2006
|
|||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and cash equivalents
|
$
|
521
|
$
|
228
|
|||
Prepaid
insurance
|
101
|
179
|
|||||
Prepaid
expenses and other current assets
|
58
|
60
|
|||||
Total
current assets
|
680
|
467
|
|||||
PROPERTY,
PLANT & EQUIPMENT, NET
|
1,143
|
1,145
|
|||||
DEPOSITS
|
7
|
7
|
|||||
TOTAL
ASSETS
|
$
|
1,830
|
$
|
1,619
|
|||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Senior
secured convertible bridge term notes, net
|
$
|
8,805
|
$
|
7,005
|
|||
Conversion
features on bridge term notes
|
-
|
16,750
|
|||||
Secured
term note
|
5,000
|
5,000
|
|||||
Current
maturities of capital lease obligations
|
26
|
25
|
|||||
Accrued
expenses
|
757
|
328
|
|||||
Total
current liabilities
|
14,588
|
29,108
|
|||||
COMMON
STOCK WARRANTS
|
-
|
10,784
|
|||||
CAPITAL
LEASE OBLIGATIONS, less current maturities
|
-
|
7
|
|||||
TOTAL
LIABILITIES
|
14,588
|
39,899
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
STOCKHOLDERS'
DEFICIT
|
|||||||
Common
stock - $.01 par value;
|
|||||||
650,000
shares authorized;
|
|||||||
331,597
and 330,998 shares issued and outstanding
|
|||||||
at
March 31, 2007 and December 31, 2006, respectively
|
3,316
|
3,310
|
|||||
Convertible
preferred stock - $.01 par value;
|
|||||||
72,027
shares authorized and available for issuance
|
-
|
-
|
|||||
Additional
paid-in capital
|
310,631
|
275,953
|
|||||
Accumulated
deficit
|
(326,705
|
)
|
(317,543
|
)
|
|||
STOCKHOLDERS’
DEFICIT
|
(12,758
|
)
|
(38,280
|
)
|
|||
TOTAL
LIABILITIES AND STOCKHOLDERS’ DEFICIT
|
$
|
1,830
|
$
|
1,619
|
|||
See
accompanying notes to the consolidated financial
statements.
|
2
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF OPERATIONS
UNAUDITED
(in
thousands, except per share data)
For
the three months ended March 31,
|
|||||||
2007
|
2006
|
||||||
Research
and development
|
$
|
1,196
|
$
|
1,506
|
|||
Marketing,
general and administrative
|
778
|
2,421
|
|||||
LOSS
FROM OPERATIONS
|
(1,974
|
)
|
(3,927
|
)
|
|||
OTHER
INCOME (EXPENSE)
|
|||||||
Interest
expense
|
(367
|
)
|
(225
|
)
|
|||
Interest
income
|
5
|
4
|
|||||
Amortization
of debt discount
|
(1,692
|
)
|
-
|
||||
Loss
on fair value change of conversion features
|
(3,483
|
)
|
-
|
||||
Loss
on fair value change of common stock warrants
|
(1,668
|
)
|
-
|
||||
Gain
(loss) on asset disposals
|
20
|
(7
|
)
|
||||
TOTAL
OTHER EXPENSE
|
(7,185
|
)
|
(228
|
)
|
|||
NET
LOSS
|
$
|
(9,159
|
)
|
$
|
(4,155
|
)
|
|
Basic
and diluted loss per share
allocable
to common stockholders (Note 7)
|
$
|
(0.03
|
)
|
$
|
(0.01
|
)
|
|
Weighted
average shares used in computing basic and diluted loss
per
share allocable to common stockholders (Note 7)
|
352,293
|
340,314
|
See
accompanying notes to the consolidated financial statements.
3
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENT OF STOCKHOLDERS' DEFICIT
THREE
MONTHS ENDED MARCH 31, 2007
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, 2006
|
330,998
|
$
|
3,310
|
$
|
275,953
|
$
|
(317,543
|
)
|
$
|
(38,280
|
)
|
|||||
Net
loss for three months ended March 31, 2007
|
-
|
-
|
-
|
(9,159
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)
|
(9,159
|
)
|
|||||||||
Deemed
dividend related to debt modification
|
-
|
-
|
-
|
(3
|
)
|
(3
|
)
|
|||||||||
Reclassification
of conversion feature value
|
-
|
-
|
21,086
|
-
|
21,086
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|||||||||||
Reclassification
of common stock warrant value
|
-
|
-
|
12,307
|
-
|
12,307
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|||||||||||
Conversion
feature value of issued debt
|
-
|
-
|
339
|
-
|
339
|
|||||||||||
Stock
based compensation
|
-
|
-
|
442
|
-
|
442
|
|||||||||||
Issuance
of common stock for interest
|
433
|
4
|
360
|
-
|
364
|
|||||||||||
Issuance
of common stock for cashless exercise of common stock
warrants
|
166
|
2
|
144
|
-
|
146
|
|||||||||||
Balance
at March 31, 2007
|
331,597
|
$
|
3,316
|
$
|
310,631
|
$
|
(326,705
|
)
|
$
|
(12,758
|
)
|
See
accompanying notes to the consolidated financial statements.
4
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE THREE MONTHS ENDED MARCH 31
UNAUDITED
(in
thousands, except supplemental disclosures)
|
2007
|
2006
|
|||||
Cash
flows from Operating Activities:
|
|||||||
Net
loss
|
$
|
(9,159
|
)
|
$
|
(4,155
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|||||||
Depreciation
and amortization
|
29
|
31
|
|||||
Amortization
of debt discount
|
1,692
|
-
|
|||||
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
|
364
|
-
|
|||||
Non-cash
stock compensation expense
|
442
|
2,822
|
|||||
(Gain)
loss on asset disposals
|
(20
|
)
|
7
|
||||
Changes
in assets and liabilities
|
|||||||
Prepaid
expenses and other current assets
|
81
|
92
|
|||||
Accrued
expenses
|
430
|
92
|
|||||
Total
adjustments
|
8,169
|
3,044
|
|||||
Net
cash used in operating activities
|
(990
|
)
|
(1,111
|
)
|
|||
Cash
flows from Investing Activities:
|
|||||||
Capital
expenditures
|
(27
|
)
|
(3
|
)
|
|||
Proceeds
from asset disposals
|
20
|
-
|
|||||
Net
cash used in investing activities
|
(7
|
)
|
(3
|
)
|
|||
Cash
flows from Financing Activities:
|
|||||||
Proceeds
from issuance of senior secured term notes payable
|
1,296
|
1,500
|
|||||
Proceeds
from the exercise of stock options
|
-
|
11
|
|||||
Payments
on capital lease obligations
|
(6
|
)
|
(7
|
)
|
|||
Net
cash provide by financing activities
|
1,290
|
1,504
|
|||||
Increase
in cash and cash equivalents
|
293
|
390
|
|||||
Cash
and cash equivalents at beginning of period
|
228
|
260
|
|||||
Cash
and cash equivalents at end of period
|
$
|
521
|
$
|
650
|
|||
Cash
paid for interest
|
$
|
2
|
$
|
76
|
|||
See
accompanying notes to the consolidated financial statements.
5
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)
Three
Months ended March 31, 2007
1. |
The
Company issued 247,232 shares of common stock as payment of $207,000
of
Senior Secured Convertible Bridge Term Notes Payable accrued
interest.
|
2. |
The
Company issued 185,692 shares of common stock as payment of $157,000
of
Secured Term Note Payable accrued
interest.
|
3. |
Warrants
to purchase aggregate 410,092 shares of common stock were exercised
at
exercise prices between $0.12 and $0.66 per share in a series of
cashless
exercise transactions resulting in the issuance of aggregate 165,335
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 fair value of all 15,921,000 outstanding
common stock warrants of $12,307,000 was reclassified from liabilities
to
equity.
|
Three
Months ended March 31, 2006
1. |
The
Company issued 207,856 shares of common stock as payment of $147,000
of
Secured Term Note Payable accrued
interest.
|
2. |
Warrants
to purchase 165,934 shares of common stock were exercised in March
2006 at
an exercise price of $0.48 per share in a cashless exercise transaction
resulting in the issuance of 19,065 shares of common
stock.
|
See
accompanying notes to the consolidated financial statements.
6
ACURA
PHARMACEUTICALS, INC. AND SUBSIDIARY
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2007 AND 2006
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, results of operations and
cash flows for the three months ended March 31, 2007, assuming that the Company
will continue as a going concern, have been made. The results of operations
for
the three month period ended March 31, 2007 are not necessarily indicative
of
the results that may be expected for the full year ending December 31, 2007.
The
unaudited consolidated financial statements should be read in conjunction with
the consolidated financial statements and footnotes thereto for the year ended
December 31, 2006 included in the Company's Annual Report on Form 10-K filed
with the Securities and Exchange Commission.
NOTE
2 - LIQUIDITY MATTERS
The
accompanying financial statements have been prepared assuming the Company will
continue as a going concern. At
March
31, 2007, the Company had unrestricted cash and cash equivalents of
$0.5 million, a working
capital deficit of $13.9 million, and an accumulated deficit of $326.7 million.
At December 31, 2006, the Company had cash and cash equivalents of $0.2 million,
a working
capital deficit of $28.6
million
and an accumulated
deficit of $317.5 million.
The
Company incurred a loss from operations of $2.0 million and a net loss of $9.2
million during the three months ended March 31, 2007 and a loss from operations
of $10.8 million
and a net loss of $6.0 million
during the year ended December 31, 2006. Historically,
the Company has incurred significant losses and until such time as its product
candidates are commercialized, of which no assurance can be given, the Company
will continue incurring losses. These
factors, among others, raise substantial doubt about the Company's ability
to
continue as a going concern.
The
Company estimates that its current cash reserves, including the remaining
$600,000 bridge loan commitment provided in Bridge Loan Agreements described
in
Note 9, will be sufficient to fund the development of the Aversion®
Technology and related operating expenses through mid-June 2007. To fund further
operations and product development activities, the Company must raise additional
financing, or enter into alliances or collaboration agreements with third
parties resulting in cash payments to the Company relating to its Aversion®
Technology.
The
Company is seeking to secure working capital providing gross proceeds to the
Company in the range of approximately $15 million to $20 million through the
private offering of the Company’s securities. The terms of any such securities
offering, including, without limitation, the type of equity securities (or
securities convertible into equity securities) and the price per share, have
not
been determined and will, in large part, be determined based upon negotiations
between the Company and prospective investors in such private offering. No
assurance can be given that the Company will be successful in obtaining any
such
financing or in securing collaborative agreements with third parties on
acceptable terms, if at all, or if secured, that such financing or collaborative
agreements will provide for cash payments to the Company sufficient to continue
to fund operations. In the absence of such financing or third-party
collaborative agreements, the Company will be required to scale back or
terminate operations and/or seek protection under applicable bankruptcy laws.
Even
assuming the Company is successful in securing
additional sources of financing, there can be no assurance that the Company's
development efforts will result in commercially viable products. The Company's
failure to successfully develop the Aversion®
Technology in a timely manner, to obtain issued U.S. patents relating to the
Aversion®
Technology and to avoid infringing third-party patents and other intellectual
property rights will have a material adverse impact on its financial condition
and results of operations.
7
In
view
of the matters described above, recoverability of a major portion of the
recorded asset amounts shown in the Company's accompanying consolidated balance
sheets is dependent upon continued operations of the Company, which in turn
are
dependent upon the Company's ability to meet its financing requirements on
a
continuing basis, to maintain present financing, and to succeed in its future
operations. The Company's financial statements do not include any adjustment
relating to the recoverability and classification of recorded asset amounts
or
amounts and classification of liabilities that might be necessary should the
Company be unable to continue in existence.
NOTE
3 - NEW ACCOUNTING PRONOUNCEMENTS
Uncertainty
in Income Taxes
In
July
2006, the Financial Accounting Standards Board (“FASB”) issued Interpretation
No. 48 regarding "Accounting for Uncertainty in Income Taxes," an interpretation
of FASB Statement No. 109 ("FIN 48"), which defines the threshold for
recognizing the benefits of tax-return positions in the financial statements
as
"more-likely-than-not" to be sustained by the taxing authorities. The Company
has reviewed its tax positions for open tax years of 2003 through 2005 and
the
adoption of FIN 48 on January 1, 2007 did not result in establishing a
contingent tax liability reserve nor a corresponding charge to retained
earnings. The Company has substantial tax benefits derived from its net
operating loss carryforwards but has provided 100% valuation allowances against
them due to uncertainties associated with the realization of those tax benefits
(Note 5).
The
recognition and measurement of certain tax benefits includes estimates and
judgment by management and inherently includes subjectivity. Changes in
estimates may create volatility in the Company’s effective tax rate in future
periods from obtaining new information about particular tax positions that
may
cause management to change its estimates. If the Company would establish a
contingent tax liability reserve, interest and penalties related to uncertain
tax positions would be classified in general and administrative expenses.
Fair
Value Measurements
In
September 2006, the FASB issued Statement of Financial Accounting Standards
157,
“Fair Value Measurements (“SFAS 157”). SFAS 157 defines fair value, establishes
a framework for measuring fair value under generally accepted accounting
principles, and expands disclosures about fair value measurements. SFAS 157
is
effective for financial statements issued for fiscal years beginning after
November 15, 2007, and interim periods within those fiscal years. The Company
is
currently evaluating the impact the adoption of this statement could have on
is
financial condition, results of operations and cash flows.
NOTE
4 -
RESEARCH AND DEVELOPMENT
Research
and Development (“R&D”) expenses include internal R&D activities
and external Contract Research Organization activities (“CRO”). Internal
R&D expenses include facility overhead, maintenance, repair and
depreciation, laboratory supplies, pre-clinical laboratory experiments,
equipment maintenance, repairs and depreciation, salaries, benefits, incentive
compensation and other administrative expenses. CRO expenses
include preclinical laboratory experiments, clinical trials, clinical trial
and
regulatory consulting, regulatory counsel and patent counsel. R&D
expenses are charged to operations as incurred. The Company reviews and
accrues clinical trial expenses based on work performed and relies on an
estimate of the costs applicable to the stage of completion of a clinical trial
as provided by the CRO. Accrued clinical 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. The
Company’s $162,000 binding research and development commitment at December 31,
2006 has been incurred and accrued at March 31, 2007. This amount is expected
to
be paid in May 2007.
NOTE
5 - INCOME TAXES
The
Company accounts for income taxes under the liability method in accordance
with
Statement of Financial Accounting Standards No. 109 ("SFAS 109"), "Accounting
for Income Taxes." Under this method, deferred income tax assets and liabilities
are determined based on differences between financial reporting and tax basis
of
assets and liabilities and are measured using the enacted tax rates and laws
that will be in effect when the differences are expected to reverse.
Additionally, income tax credit carryforwards are reported as deferred income
tax assets. At December 31, 2006, the Company has gross Federal, state, and
city
operating loss carryforwards aggregating $141.2 million, $101.0 million,
and
$46.3 million, respectively, expiring during the years 2009 through 2026.
The
tax loss carryforwards of the Company and its subsidiary may be subject to
limitation by Section 382 of the Internal Revenue Code with respect to the
amount utilizable each year. This limitation reduces the Company's ability
to
utilize net operating loss carryforwards each year. The amount of the limitation
has not been quantified. SFAS 109 requires a valuation allowance against
deferred tax assets if, based on the weight of available evidence, it is
more
likely than not that some or all of the deferred tax assets may not be realized.
At both March 31, 2007 and December 31, 2006, a valuation allowance equal
to
100% of the net deferred income tax assets was used and primarily pertains
to
uncertainties with respect to future utilization of net operating loss
carryforwards. In the event the Company were to determine that it would be
able
to realize some or all its deferred income tax assets in the future, an
adjustment to the deferred income tax asset would increase income in the
period
such determination was made.
8
NOTE
6 - STOCK-BASED COMPENSATION
The
Company has several stock-based compensation plans covering 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”)”. This
change in accounting replaces existing requirements under FASB 123 and
eliminates the ability to account for share-based compensation transactions
using APB Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB 25”).
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 measure of the fair value of its employee stock options.
Included
in the results for the three months ended March 31, 2007 and 2006 are $442,000
and $2.8 million of stock-based compensation expense relating to the February
2006 grant of restricted stock units to the Company’s independent directors and
stock based compensation expenses relating to vesting of stock options and
restricted stock units granted to Company employees prior to 2006. No options
or
restricted stock units have been issued since February 2006.
Restricted
Stock Unit Award Plan
On
December 22, 2005, the Board of Directors approved the Company’s 2005 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 30 million shares of common stock are
authorized for issuance under the 2005 RSU Plan. The Company believed that
the
2005 RSU Plan did not require shareholder approval. Nevertheless, the Company’s
shareholders ratified the 2005 RSU Plan at its December, 2006 Annual
Shareholders’ Meeting.
The
RSU
Plan is administered by the Company’s Board of Directors or a Committee
appointed by the Board of Directors. RSUs granted under the 2005 RSU Plan vest
on a schedule determined by the Board of Directors or such Committee as set
forth in a restricted stock unit award agreement. Unless otherwise set forth
in
such award agreement, the RSUs fully vest upon a change in control of the
Company (as defined in the 2005 RSU Plan) or upon termination of an employee’s
employment with the Company without cause or due to death or disability, and
in
the case of a non-employee director, such person’s death or disability or if
such person is not renominated as a director (other than for “cause” or refusal
to stand for re-election) or is not elected by the Company’s stockholders, if
nominated. Vesting of an RSU entitles the holder thereof to receive a share
of
common stock of the Company on a distribution date (after payment of the $0.01
par value per share).
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. No dividends
accrue on the shares underlying the RSUs prior to issuance by the Company.
The
recipients of RSU awards need not be employees or directors of the Company
on a
distribution date. RSUs may generally not be transferred, except recipients
of
RSUs may designate beneficiaries to inherit their RSUs upon their death.
In
December 2005, an aggregate of 27,500,000 RSUs were granted to the Company’s
employees. In February 2006, an aggregate of 2,000,000 RSUs were granted
to the
Company’s two independent directors. Of the RSU awards granted, approximately
one third vested upon grant and the other two thirds will vest on a
straight-line monthly basis through December 2007. During the three months
ended
March 31, 2007, 2,458,000 RSUs vested. Of the RSU awards granted, 22,125,000
and
19,667,000 were vested as of March 31, 2007 and December 31, 2006, respectively
and 7,375,000 and 9,833,000 were nonvested as of March 31, 2007 and December
31,
2006, respectively.
The
weighted average fair value of both RSU grants is $0.35 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 stock-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 for the three months ending March 31, 2006 was $680,000 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 is being amortized
using
a graded vesting method which treats the December 2005 RSU grant as a series
of
awards rather than a single award and attributes a higher percentage of the
reported fair value to the earlier years than to the later years. At March
31,
2007, the total remaining unrecognized compensation expense related to the
nonvested December 2005 RSU awards was $659,000. This amount will be recognized
over the next 9 months. The Company recognized compensation expense from
the RSU
awards of $5,264,000 and $4,261,000, during the years ended December 31,
2006
and 2005, respectively. No related tax benefits were recorded in calendar
year
2006 and 2005. As of March 31, 2007 and December 31, 2006, the aggregate
intrinsic value of the RSU awards outstanding and vested was $18,585,000
and
$14,357,000, respectively. As discussed above, the RSU awards are distributable
only upon the occurrence of certain events or beginning January 1,
2011.
As
of
March 31, 2007, the total remaining unrecognized compensation expense relating
to unvested outstanding stock options is less than $50,000.
9
NOTE
7-
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
March 31, 2007 and 2006 are 78.3 million and 53.0 million, respectively, of
potentially dilutive securities, as the effect of including them would be
antidilutive. Accordingly, the loss per share is the same result from both
basic
and diluted computations.
Net
loss
used in the Company’s earnings (loss) per share computations includes the impact
in 2007 of dividends deemed to have been issued to certain common shareholders
as a result of modifications to debt agreements with those shareholders, as
further described in Note 9.
Three
months ended
March
31,
|
|||||||
(in
thousands, except per share data)
|
2007
|
2006
|
|||||
Numerator:
|
|||||||
Net
loss
|
$
|
(9,159
|
)
|
$
|
(4,155
|
)
|
|
Deemed
dividend from modification of debt
|
(3
|
)
|
-
|
||||
Net
loss allocable to common stockholders
|
$
|
(9,162
|
)
|
$
|
(4,155
|
)
|
|
Denominator:
|
|||||||
Common
shares (weighted)
|
331,079
|
329,304
|
|||||
Vested
restricted stock units (weighted)
|
21,214
|
11,010
|
|||||
Weighted
average shares used in computing
basic
and diluted loss per share allocable to common
stockholders
|
352,293
|
340,314
|
|||||
Basic
and diluted loss per share allocable
to common stockholders
|
$
|
(0.03
|
)
|
$
|
(0.01
|
)
|
|
Potentially
dilutive securities:
|
|||||||
Common
stock issuable (see #1 below)
|
|||||||
Vested
and nonvested employee and director stock options
|
18,995
|
19,755
|
|||||
Nonvested
restricted stock units
|
7,375
|
17,208
|
|||||
Common
stock warrants
|
15,921
|
16,076
|
|||||
Convertible
term bridge notes
|
35,963
|
-
|
|||||
Total
excluded dilutive common stock equivalents
|
78,254
|
53,039
|
|||||
(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
year end. Such amounts have not been adjusted for the treasury stock
method or weighted average outstanding calculations required if the
securities were dilutive.
|
10
NOTE
8 - ACCRUED EXPENSES
Accrued
expenses are summarized as follows (in thousands):
Mar
31,
|
Dec
31,
|
||||||
2007
|
2006
|
||||||
Bonus,
payroll, payroll taxes and benefits
|
$
|
79
|
$
|
62
|
|||
Legal
fees
|
25
|
19
|
|||||
Audit
examination and tax preparation fees
|
51
|
70
|
|||||
Franchise
taxes
|
19
|
15
|
|||||
Property
taxes
|
59
|
52
|
|||||
Clinical,
regulatory and patent consulting fees
|
249
|
60
|
|||||
Clinical
trials
|
162
|
-
|
|||||
Market
research
|
34
|
-
|
|||||
Other
fees and services
|
79
|
50
|
|||||
$
|
757
|
$
|
328
|
NOTE
9 - NOTES PAYABLE AND BRIDGE LOAN AGREEMENTS
Notes
payable are summarized as follows (in thousands):
|
Mar
31,
|
Dec
31,
|
|||||
2007
|
2006
|
||||||
Senior
secured convertible bridge term notes (a):
|
|||||||
Face
value
|
$
|
9,144
|
$
|
7,848
|
|||
Debt
discount
|
(339
|
)
|
(843
|
)
|
|||
|
8,805
|
7,005
|
|||||
Conversion
feature value
|
-
|
16,750
|
|||||
$
|
8,805
|
$
|
23,755
|
||||
Secured
term note (b)
|
$
|
5,000
|
$
|
5,000
|
|||
Capital
lease obligations
|
$
|
26
|
$
|
32
|
(a)
Senior Secured Convertible Bridge Term Notes
Pursuant
to a series of loan agreements between the Company, Galen Partners III, L.P.
and
its affiliates, Care Capital Investments II, LP and its affiliate, and Essex
Woodlands Health Ventures V, L.P. (collectively, the “VC Investors”), and
certain other shareholders of the Company dating from June 2005 to January
2006
- all as amended through March 2007, the Company has borrowed $9,144,000 as
of
March 31, 2007 and an additional $200,000 in April 2007 (the “Bridge Loans”).
The amount of additional borrowings available under the loan agreement at May
2,
2007 is $600,000. The proceeds from the Bridge Loans have been and continue
to
be used by the Company to develop its Aversion® Technology and fund related
operating expenses. The Bridge Loans carry an interest rate of 10%, payable
quarterly which, pursuant a November 2006 amendment, is payable, at the
Company’s option, with shares of its Common Stock. The Bridge Loans, as amended
in March 2007, mature on September 30, 2007.
11
The
Bridge Loans are secured by a lien on all of the Company’s assets, senior in
right to all other Company indebtedness and restrict its ability to issue any
shares of the Company’s currently authorized Series A, B or C convertible
preferred stock without the prior consent of the bridge lenders, and grants
the
bridge lenders preemptive rights relating to the issuance of the Company’s
Series A, B and C convertible preferred stock. The Bridge Loans contain cross
default provisions with the 2004 Note (described in (b) below) and each of
the
outstanding Bridge Loans. The Bridge Loans also contain normal and customary
affirmative and negative covenants, including restrictions on the Company’s
ability to incur additional debt or grant any lien on the Company’s assets or
the assets of its subsidiary, subject to certain permitted exclusions.
Additionally, the Bridge Notes require immediate prepayment upon a qualifying
common stock equity or debt financing or any sale, transfer license or similar
arrangement pursuant to which the Company sells, licenses or otherwise grant
rights in any material portion of the Company’s intellectual property to any
third party, provided that the consummation of any such transaction results
in
certain minimum amounts of cash proceeds to the Company, net of all costs and
expenses.
Through
August 2006, the terms of the Bridge Loans did not include any conversion
provisions. An August 2006 amendment added a conversion feature which allowed,
at the lenders’ option, the Bridge Loans to be converted into the Company’s
Common Stock upon a qualifying equity financing at a conversion price equal
to
the per share price implicit in such equity financing. The Company did not
assign any value to the new conversion feature as it did not provide the lenders
with an opportunity to receive value in a conversion in excess of the face
value
of the debt regardless of the per share price of that equity
financing.
In
November 2006 and March 2007, the conversion feature of the Bridge Loans was
further amended to allow the bridge loan lenders to convert the Bridge Loans
into the Company’s common stock, upon the completion of a third-party equity
financing providing gross proceeds to the Company in the aggregate amount of
at
least $5 million (a “Third Party Equity Financing”), a Change of Control
Transaction or upon the maturity date of the Bridge Loans (each a “Triggering
Event”). Upon the occurrence of a Triggering Event, the bridge lenders may
convert $2.6 million (as of May 2, 2007) of Bridge Loans into the Company’s
common stock at a conversion price equal to (A) in the case of the completion
of
a Third Party Equity Financing, the lesser of (i) 80% of the average closing
bid
and asked prices of the Company’s common stock for the twenty trading days
immediately preceding the public announcement of the Third Party Investor
Financing, but not less than $0.21 per share (ii) the average price of the
securities sold by the Company in such Third Party Equity Financing (80% of
such
average price in the case of $600,000 of Bridge Loans), and (iii) $0.44 per
share for $2.0 million of Bridge Loans and $0.46 per share for $600,000 of
Bridge Loans and (B) in the case of a Change of Control Transaction or upon
the
maturity date of the Bridge Loans, the lesser of (i) 80% of the average closing
bid and asked prices of the Registrant’s common stock for the twenty trading
days immediately preceding the public announcement of the Change of Control
Transaction or the maturity date, as applicable, but not less than $0.21 per
share, and (ii) $0.44 per share for $2.0 million of Bridge Loans and $0.46
per
share for $600,000 of Bridge Loans. In addition, upon a Triggering Event, the
bridge lenders may convert $2.55 million of Bridge Loans into the Company's
common stock at a conversion price of $0.20 per share, $2.3 million of Bridge
Loans at a conversion price of $0.225 per share and $1.894 million of Bridge
Loans at a conversion price of $0.25 per share.
The
November and December 2006 issuances of Bridge Loans for an aggregate face
value
of $1,104,000 included this amended conversion feature which the Company valued
at an aggregate of $1,034,000. This value was recorded as a liability with
an
offsetting $1,025,000 debt discount (which was amortized over the term of the
Bridge Loans) and $9,000 of issuance loss. However, as the debt was issued
to
shareholders who control the Company, this loss was recorded as a non-cash
deemed dividend rather than effecting net loss. Additional issuances of $896,000
of Bridge Loans in January and February 2007 similarly had aggregate conversion
feature value of $849,000 and a loss upon issuance of $3,000.
12
The
November 2006 amendment of the conversion feature on all of the then outstanding
Bridge Loans, coupled with the requirement under current accounting guidance
to
separate the value of the conversion feature from the debt, required the Company
to record the value of the amended conversion feature on that outstanding debt
as a liability and a loss on the modification of debt. The Company assigned
a
value of $19.951 million to these conversion features at date of modification
and reflected that loss as non-cash deemed dividend.
Upon
revaluing the aggregate conversion features on all outstanding Bridge Loans
as
of March 30, 2007 (the date immediately before further amendment to the Bridge
Loans), the Company recorded the resulting increase in value as a $3.483 million
loss. The increase in the Company’s common stock trading price from December 31,
2006 to March 30, 2007 resulted in the increase in the value of the conversion
liability. The Bridge Loan amendment on March 30, 2007 limited the conversion
price of the post-October 2006 loans to no lower than $0.21 per share. With
this
limit in place, the outstanding conversion feature no longer had to be reflected
as Company liabilities. As such, the Company recorded a $21.1 million
reclassification of that liability to additional paid-in capital.
To
compute the estimated value of the conversion features just prior to the
reclassification described above and at the previous year end, the Company
used
the Black-Scholes option-pricing model with the following assumptions on these
dates:
|
March
30,
2007
|
December
31,
2006
|
|
Company
stock price
|
$
0.85
|
$
0.74
|
|
Exercise
price
|
(see
note below)
|
(see
note below)
|
|
Expected
dividend
|
0.0%
|
0.0%
|
|
Risk
-free interest rate
|
5.07%
|
5.0%
|
|
Expected
volatility
|
none
|
88.8%
|
|
Contracted
term
|
1
day
|
3
months
|
Note:
The
conversion price per share used to estimate fair value of the Bridge Loan
conversion rights was equal to the fixed conversion price per share set forth
above for each of the specified Bridge Loan amounts. While the Bridge Loan
Agreements provide for other than fixed conversion prices under certain
circumstances, the Company has judged that the fixed conversion prices will
most
likely be the lowest price per share under any of the circumstances and the
lender would therefore select such fixed price for their
conversion.
The
conversion features related to the March 30, 2007 and April 2, 2007 Bridge
Note
issuances were not required to be separated and accounted for at fair value.
However, based on the conversion price of those notes, the issuances did include
beneficial conversion features whereby the common stock to be issued upon
conversion would be worth more than the underlying debt if converted upon
issuance. That incremental value, computed as $339,000 and $170,000,
respectively, was recorded as additional paid in capital and as debt discount,
which will be amortized over the six month term of the notes.
(b) Secured
Term Note
The
Company was a party to a certain loan agreement with Watson Pharmaceuticals,
Inc. ("Watson") pursuant to which Watson made term loans to the Company (the
"Watson Term Loan Agreement") in the aggregate principal amount of $21.4 million
as evidenced by two promissory notes (the "Watson Notes"). As part of the
Company’s 2004 debenture offering, the Company paid Watson $4.3 million (which
amount was funded from the proceeds of the Company’s 2004 debenture offering)
and conveyed to Watson certain Company assets in consideration for Watson's
forgiveness of approximately $16.4 million of indebtedness under the Watson
Notes, resulting in a $12.4 million gain for the Company. As part of such
transaction, the Watson Notes were amended to extend the maturity date of such
notes from March 31, 2006 to June 30, 2007, to provide for satisfaction of
future interest payments under the Watson Notes in the form of the Company's
Common Stock, to reduce the principal amount of the Watson Notes from $21.4
million to $5.0 million, and to provide for the forbearance from the exercise
of
rights and remedies upon the occurrence of certain events of default under
the
Watson Notes (the Watson Notes as so amended, the "2004 Note"). Simultaneous
with the issuance of the 2004 Note, each of Care Capital, Essex Woodland Health
Ventures, Galen Partners and the other investors in the Company’s 2004
debentures as of February 10, 2004 (collectively, the "2004 Note Purchasers")
purchased the 2004 Note from Watson in consideration for a payment to Watson
of
$1.0 million.
The
2004
Note in the principal amount of $5.0 million, as purchased by the 2004 Note
Purchasers, is secured by a lien on all of the Company's and its subsidiaries'
assets, carries a floating rate of interest equal to the prime rate plus 4.5%
and matures on June 30, 2007. The carrying interest rate at March 31, 2007
and
December 31, 2006 was 12.75%. The
2004
Note contains cross default provisions with each of the outstanding Bridge
Loans. The majority holders of the Bridge Loans also are the majority holders
of
the 2004 Note. To the extent cash is not available to the Company to pay this
near-term debt obligation upon maturity, the Company expects to negotiate with
its lenders to arrange for alternative means to settle the obligations,
including, without limitation, the possible extension of maturity or conversion
of the 2004 Note into equity.
13
NOTE
10 - COMMON STOCK WARRANTS
At
March
31, 2007, the Company had outstanding common stock purchase warrants exercisable
for an aggregate of 15,921,000 shares of common stock. Of such outstanding
warrants, 4,884,000 were
issued in connection with the issuance of bridge loans and financing commitments
from 2001 through 2003, 10,701,000 were issued to Watson in connection
with
their agreement to amend the Watson Notes at December 20, 2002, and 336,000
were
issued in 2003 as part of the settlement terms with a former executive
officer
of the Company. During the three months ended March 31, 2007, warrants
to
purchase aggregate 410,092 shares of Common Stock were exercised at exercise
prices between $0.12 and $0.66 per share in a series of cashless exercise
transactions resulting in the issuance of aggregate 165,000 shares of Common
Stock. At March 31, 2007, outstanding common stock purchase warrants of
154,000,
4,085,000 and 11,682,000 will expire if unexercised during the years 2008,
2009
and thereafter, respectively, with a weighted average remaining term of
5.3
years. The exercise prices of the warrants range from $0.12 to $0.34 per
share,
with a weighted average price of $0.33.
As
a
result of the November 2006 amendment to the Bridge Loans, the Company’s
outstanding common stock purchase warrants started being accounted for as
mark-to-market liabilities with a recorded value of $10,784,000 at December
31,
2006. Upon revaluing the warrants as of March 30, 2007 (the date immediately
before further amendment to the Bridge Loans), the Company recorded the
resulting increase in value as a $1.668 million loss. The increase in the
Company’s common stock trading price from December 31, 2006 to March 30, 2007
resulted in the increase in the value of the warrant liability. The Bridge
Loan
amendment on March 30, 2007 limited the conversion price of the post-October
2006 loans to no lower than $0.21 per share. With this limit in place, the
outstanding warrants no longer had to be reflected as Company liabilities.
As
such, the Company recorded a 12.3 million reclassification of that liability
to
additional paid-in capital. To compute the estimated value of the warrant
liability just prior to the reclassification described above and at the previous
year end, the Company used the Black-Scholes option-pricing model with the
following assumptions on these dates:
March
30,
2007
|
December
31,
2006
|
||
Company
stock price
|
$
0.85
|
$
0.74
|
|
Exercise
price
|
$
0.12 - $ 0.34
|
$
0.12 - $ 0.66
|
|
Expected
dividend
|
0.0%
|
0.0%
|
|
Risk-free
interest rate
|
4.54%
- 4.70%
|
4.7%
- 5.0%
|
|
Expected
volatility
|
114.3%
- 135.8%
|
48.4%
- 143.5%
|
|
Weighted
-average volatility
|
127.7%
|
127.7%
|
|
Contractual
term
|
1.4
years -
6.8
years
|
38
days -
6.8
years
|
14
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 the actual results, performance or achievements
of
Acura Pharmaceuticals, Inc. (the “Company”), 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, the Company’s ability to secure additional financing to fund
continued product development and operations, the Company’s ability to enter
into contractual arrangements with qualified pharmaceutical partners to license,
develop and commercialize the Company’s Aversion® (abuse deterrent) Technology
and related product candidates, and the Company’s ability to fulfill the U.S.
Food and Drug Administration’s (“FDA”) requirements for approving the Company’s
product candidates for commercial 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 the Company’s product candidates, the
adequacy of the development program for the Company’s product candidates,
changes in regulatory requirements, adverse safety findings relating to the
Company’s product candidates, the risk that the FDA may not agree with the
Company’s analysis of its clinical studies and may evaluate the results of these
studies by different methods or conclude that the results of the studies are
not
statistically significant, clinically meaningful or that there were human errors
in the conduct or otherwise of the studies , the risk that further studies
of
the Company’s product candidates 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: the Company’s ability to attract and retain highly skilled
personnel; its ability to secure and protect its patents, trademarks and
proprietary rights; its ability to avoid infringement of patents, trademarks
and
other proprietary rights or trade secrets of third parties; litigation or
regulatory action that could require the Company to pay significant damages
or
change the way it conducts its business; the Company’s ability to compete
successfully against current and future competitors; its dependence on
third-party suppliers of raw materials; its ability to secure U.S. Drug
Enforcement Administration ("DEA") quotas and source controlled substances
that
constitute the active ingredients of the Company’s products in development;
difficulties or delays in clinical trials for Company products or in the
manufacture of Company products; and other risks and uncertainties detailed
in
this Report. The Company is at development stage and may not ever have any
products or technologies that generate revenue. When used in this Report, the
words "estimate," "project," "anticipate," "expect," "intend," "believe," and
similar expressions are intended to identify forward-looking
statements.
Company
Overview
Acura
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research,
development and manufacture of innovative Aversion® (abuse deterrent) Technology
and related product candidates. Product candidates developed with Aversion®
Technology and containing opioid analgesic active ingredients are intended
to
effectively treat pain and also discourage the three 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. OxyADF Tablets, the Company’s 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”). The Company conducts internal research, development, laboratory,
manufacturing and warehousing activities for Aversion® Technology at its Culver,
Indiana facility. The 28,000 square foot facility is registered by the U.S.
Drug
Enforcement Administration (“DEA”) to perform research, development and
manufacture of certain Schedule II - V finished dosage form products. In
addition to internal capabilities and activities, the Company engages numerous
of pharmaceutical product contract research organizations (“CROs”) with
expertise in regulatory affairs, clinical trial design and monitoring, clinical
data management, biostatistics, medical writing, laboratory testing and related
services. Such CROs perform development services for OxyADF Tablets and other
product candidates under the direction of the Company.
The
Company is focused on (i) development
and evaluation, in concert with CROs, product candidates utilizing the Company's
Aversion®
Technology; (ii) manufacture, quality assurance testing and release, and
stability studies of clinical trial supplies and NDA submission batches of
certain finished dosage form product candidates utilizing Aversion®
Technology; (iii) prosecution of the Company’s patent applications relating to
Aversion®
Technology with the United States Patent and Trademark Office (“PTO”) and
foreign equivalents; and (iv) negotiation and execution of license and
development agreements with pharmaceutical company partners providing that
such
licensees will further develop certain finished dosage product candidates
utilizing the Aversion®
Technology and file for regulatory approval with the United States Food and
Drug
Administration (“FDA”) and other regulatory authorities and commercialize such
products.
15
The
Company was historically engaged in development of novel manufacturing processes
(the "Opioid Synthesis Technologies") intended for use in the commercial
manufacture of certain bulk opioid active pharmaceutical ingredients. In early
2005, the Company announced the suspension of activities relating to the Opioid
Synthesis Technologies pending the deputy DEA Administrator's determination
relating to the Company’s pending application for registration to import
narcotic raw materials (the "Narcotic Raw Materials Import Application") filed
with the DEA in early 2001. In late 2006, the Company notified the DEA that
it
was withdrawing the Narcotic Raw Materials Import Application and subsequently,
the Company has discontinued all activities relating to the Opioid Synthesis
Technologies. The withdrawal of the Narcotic Raw Material Import Application
and
the discontinuation of all activities relating to the Opioid Synthesis
Technologies allows the Company to focus all of its resources on developing
and
commercializing its Aversion® (abuse deterrent) Technology and related product
candidates.
Company’s
Present Financial Condition
At
March
31, 2007, the Company had unrestricted cash and cash equivalents of $0.5 million
compared to $0.2 million at December 31, 2006. The Company had a working capital
deficit of $13.9 million and $28.6 million at March 31, 2007 and December 31,
2006, respectively. The Company had an accumulated deficit of $326.7 million
and
$317.5
million at March
31,
2007 and December 31, 2006, respectively. The
Company incurred a loss from operations of $2.0 million and a net loss of $9.2
million during the three months ended March 31, 2007 and a loss from operations
of $10.8 million
and a net loss of $6.0 million
during the year ended December 31, 2006.
On
May 2,
2007, the Company had cash and cash equivalents of approximately $170,000.
The
Company estimates that its current cash reserves, including the remaining
$600,000 bridge loan commitment under the March 2007 bridge loan amendment,
will
fund continued development of the Aversion®
Technology and related operating expenses through mid-June 2007.
The
Company has incurred net losses since 1992 and the Company's consolidated
financial statements for each of the years ended December 31, 2006, 2005, 2004
and 2003 were prepared on a going-concern basis, expressing substantial doubt
about the Company's ability to continue as a going-concern as a result of
recurring losses and negative cash flows. The Company's future profitability
will depend on several factors, including (i)
the
Company’s ability to secure additional financing to fund continued operations;
(ii) the
successful completion of the formulation development, clinical testing and
acceptable regulatory review of product candidates utilizing the
Aversion®
Technology; (iii) the Company's ability to negotiate and execute appropriate
licensing, development and commercialization agreements with interested third
parties relating to the Company’s product candidates; and, (iv) the successful
commercialization by licensees of products incorporating the
Aversion®
Technology without infringing the patents and other intellectual property rights
of third parties.
Status
of Patent Applications, Patent Publications, and Issued
Patents
In
April
2007, the United States Patent and Trademark Office (the “USPTO”) granted to the
Company U.S. Patent No. 7,201,920 titled ”Methods and Compositions for Deterring
Abuse of Opioid Containing Dosage Forms”. The allowed patent claims
encompass pharmaceutical compositions intended to reduce or discourage the
three most common methods of prescription opioid analgesic product misuse and
abuse including; (i) intravenous injection of dissolved tablets or capsules;
(ii) snorting of crushed tablets or capsules and; (iii) intentionally swallowing
excess quantities of tablets or capsules. The opioid analgesics in the
allowed patent claims include oxycodone, hydrocodone, hydromorphone, morphine,
codeine, tramadol, propoxyphene and many others.
In
addition to issued U.S. Patent No. 7,201,920, as of the date of this Report,
the
Company has pending five U.S. non-provisional patent applications, four WO/PCT
patent applications and multiple additional U.S. provisional and international
patent filings relating to compositions containing opioid analgesics and other
abuseable drugs. Additionally, the Company has seven U.S. patents issued and
one
U.S. patent application pending related to its Opioid Synthesis
Technologies.
As
of the date of this Report, the Company retained
ownership of all intellectual property and commercial rights to its product
candidates and technologies.
16
Status
of Strategy with Commercial Partners
To
generate revenue the
Company plans to enter into development and commercialization agreements with
strategically focused pharmaceutical company partners (the "Partners") providing
that such Partners license product candidates utilizing the Company’s
Aversion®
Technology and further develop, register and commercialize multiple formulations
and strengths of such product candidates. The Company expects to receive
milestone payments and a share of profits and/or royalty payments derived from
the Partners' sale of products incorporating the Aversion®
Technology. Future
revenue, if any, will be derived from milestone payments and a share of profits
and/or royalty payments relating to such collaborative partners' sale of
products incorporating the Aversion®
Technology. As of the date of this Report, the Company did not have any executed
collaborative agreements with Partners, nor can there be any assurance that
the
Company will successfully enter into such collaborative agreements in the
future.
OxyADF
Tablets Development Status
OxyADF
(oxycodone HCl/niacin) Tablets, the Company’s lead product candidate with
Aversion® (abuse deterrent) Technology, is an orally administered immediate
release tablet containing oxycodone HCl as its sole active analgesic ingredient
and a sub therapeutic amount of niacin. The Company intends to file a 505(b)(2)
NDA for OxyADF Tablets with an anticipated indication for treating moderate
to
moderately severe pain. OxyADF Tablets are intended to effectively treat
moderate to moderately severe pain while also discouraging or deterring the
three most common methods of misuse and abuse including (i) intravenous
injection of dissolved tablets, (ii) nasal snorting of crushed tablets and
(iii)
intentional swallowing of excessive numbers of tablets. OxyADF Tablets are
being
developed pursuant to an active investigational new drug application (“IND”) on
file with the FDA. The FDA has provided written guidance to the Company stating
that OxyADF Tablets are an appropriate product candidate for submission as
a
505(b)(2) NDA and has confirmed in writing to the Company that no additional
toxicology studies are required prior to submission of such NDA.
OxyADF
Tablets: Technical and Pre-Clinical Development and Regulatory Affairs
Program
The
technical and pre-clinical development program and regulatory strategy and
status for OxyADF Tablets are summarized below. At this stage, we can not
provide any assurance
that FDA will not require additional pre-clinical studies not listed below,
or
revise the OxyADF Tablets regulatory requirements prior to their acceptance
for
filing of a 505(b)(2) NDA submission for OxyADF Tablets.
Technical
and Pre-Clinical Development
|
Status
|
Formulation
development
|
Complete
|
Pilot
bioequivalence study
|
Complete
|
Pivotal
oxycodone extraction study #1
|
Complete
(results summarized below)
|
Pivotal
oxycodone extraction study #2
|
Protocol
drafted. Results intended for use in product labeling
|
Tablet
stability for NDA submission
|
Testing
in process. 18 month real time data demonstrates stability acceptable
for
NDA submission
|
Toxicology
studies
|
Not
required per FDA written guidance to the
Company
|
Regulatory
Affairs
|
Status
|
Investigational
New Drug Application (IND)
|
Active
|
End
of Phase II meeting with FDA
|
Completed
Q1-06
|
Factorial
design clinical studies
|
Not
required per FDA written guidance to Company
|
Product
labeling
|
Strategy
and concepts discussed with FDA. Written guidance provided by FDA
to the
Company
|
Regulatory
submission for commercial distribution in the U.S.
|
OxyADF
Tablets are eligible for submission as a 505(b)(2) NDA per FDA written
guidance to Company
|
Phase
III pivotal clinical trial
|
A
single phase III efficacy and safety trial is required per FDA written
guidance to Company
|
17
Aversion®
Technology: Intended to Deter I.V. Injection of Opioids Extracted from Dissolved
Tablets
Prospective
drug abusers or recreational drug users may attempt to dissolve currently
marketed oxycodone-containing tablets in water, alcohol, or other common
solvents, filter the dissolved solution, and then inject the resulting fluid
intravenously to obtain euphoric effects. In addition to its two active
ingredients, OxyADF Tablets also contains a unique combination of inactive
ingredients. These "functional" inactive ingredients are commonly used
pharmaceutical excipients which elicit no therapeutic effect but which have
specific non-therapeutic functions. If a person attempts to extract oxycodone
from OxyADF Tablets using any generally available solvent, including water
or
alcohol, into a volume and form suitable for I.V. injection, the tablet converts
into a viscous gel matrix and effectively traps the oxycodone HCl in the gel.
Based on controlled in-vitro experiments, the Company believes it is not
possible, without extraordinary difficulty, to draw this viscous gel through
a
needle into a syringe for I.V. injection. We believe that this gel forming
feature will substantially discourage prospective
I.V. drug abusers or recreational drug users from extracting oxycodone from
an
OxyADF Tablet. As
described below, the
Company
has
compared the
relative difficulty of extracting oxycodone from OxyADF Tablets to several
currently marketed oxycodone-containing products.
Pivotal
Oxycodone Extraction Study:
The
Company, in concert with a leading pharmaceutical laboratory CRO (the
“Laboratory CRO”), completed a pivotal study to assess certain properties of
OxyADF using tablets from batches manufactured by the Company at its Culver
Facility at a scale of sufficient size to fulfill the FDA’s requirements for a
505(b)(2) NDA submission. The
Laboratory CRO was contracted to quantitatively and qualitatively measure the
relative difficulty of extracting oxycodone HCl for purposes of intravenous
(I.V.) injection from tablet products containing oxycodone HCl. The Laboratory
CRO was provided with a list of all ingredients (active and inactive) contained
in each product, allotted up to 80 hours total time to complete the evaluations
and allowed to use any methodology desired to attempt to extract oxycodone
HCl
from the tablets in a form suitable for I.V. injection. Products tested were
OxyADF (oxycodone HCl/niacin) Tablets, OxyContin® (oxycodone HCl
Controlled-Release) Tablets, generic oxycodone HCl Tablets, and Percocet®
(oxycodone HCl/acetaminophen, 5mg/325mg) Tablets. As
set
forth in the table below, results were reported as (i) percent of drug
extracted, (ii) time to extract drug and (iii) difficulty to extract drug on
a
scale of 1-10, 1 being easy and 10 being extremely difficult. OxyContin® Tablets
and generic oxycodone HCl tablets resulted in 71-92% drug extracted in 3-6
minutes and were rated 1-2 in relative difficulty. Percocet® Tablets resulted in
75% oxycodone HCl extracted in 10 minutes (with vacuum assisted filtration)
and
was rated 3-4 in relative difficulty. OxyADF Tablets resulted in a “trace” of
oxycodone HCl extracted in 355 minutes and was rated 10 in relative difficulty.
The Company intends to utilize the data and results from this pivotal laboratory
study in its 505(b)(2) NDA submission for OxyADF Tablets to the
FDA.
Summary
Results of Pivotal Laboratory
Oxycodone
Extraction Study (described above)
Product
Tested,
Oxycodone
HCl Strength
and
Product Supplier
|
Approximate
laboratory time required
to
produce a form suitable
for
intravenous injection
|
Extraction
Scheme
and
Yield
|
Difficulty
Rating
1
= Easy
to
10
= Difficult
|
OxyContin®
Tablets
1x
40mg tablet
Purdue
Pharma
|
3
minutes
|
3
steps
~92%
Yield
|
1
|
Oxycodone
HCl Tablets
8
x
5mg tablets,
Mallinckrodt
|
6
minutes
|
3
Steps
~71%
Yield
|
2
|
Percocet®
Tablets
8
x
5/325mg tablets
Endo
Labs
|
<10
minutes
with
vacuum assisted filtration
|
3
Steps
~75%
Yield
|
3-4
|
OxyADF
Tablets
8
x
5/30mg tablets
Acura
Pharmaceuticals
|
355
minutes
with
no success
|
23
Steps
~0%
Yield
|
10
|
18
Aversion®
Technology: Intended to Deter Nasal Snorting
In
addition to potential intravenous or oral abuse, prospective drug abusers may
easily crush or grind currently marketed oxycodone-containing tablet or capsule
products. The crushed powder may then be nasally snorted and the oxycodone
in
the powder is absorbed through the lining of the nasal passages often resulting
in a rapid onset of euphoric effects. OxyADF Tablets have three mechanisms
intended to discourage nasal snorting. First, OxyADF Tablets are formulated
with
a functional excipient intended to induce mild burning and irritation of the
nasal passages if the tablets are crushed and the prospective drug abuser
attempts to snort the crushed tablets. Second, when OxyADF Tablets are crushed
and snorted, the Company expects the moisture in the nasal passages will form
a
viscous gel with the crushed tablet powder, trapping the oxycodone in the gel
and reducing the amount of oxycodone available for absorption through the lining
of the nasal passages. Third, the Company expects that the viscous gel formed
in
the nasal passages will result in a sticky mass producing an unpleasant
sensation in the nasal passages of the prospective abuser. Therefore, the
Company expects potential nasal abusers of OxyADF Tablets to experience burning
and irritation of the nasal passages, a lower level of oxycodone available
for
nasal absorption and a physically unpleasant gelatinous mass to form in the
nasal passages. The Company has evaluated the potential for reducing nasal
absorption using a standard in-vitro experimental process. As discussed below,
the Company intends to further evaluate OxyADF Tablet nasal abuse
characteristics in laboratory, animal, and phase I clinical
studies.
Aversion®
Technology: Intended to Deter Swallowing Excess Quantities of
Tablets
OxyADF
Tablets contain two active ingredients. In
each
tablet, oxycodone
HCl is included to provide analgesic effects and niacin is included as a second
active ingredient in a sub-therapeutic amount. We believe that Healthcare
providers, (including physicians, nurses, and pharmacists) generally understand
and recognize that niacin, when administered orally in immediate release tablets
in amounts exceeding by several fold the amount in each OxyADF Tablet, may
cause
a combination of unpleasant symptoms, including warmth or flushing, itching,
sweating and/or chills, headache and a general feeling of discomfort. In
addition, it is generally recognized that niacin has a well established safety
profile in long term administration at doses far exceeding the amounts in each
OxyADF Tablet. When OxyADF Tablets are administered at the anticipated
recommended maximum dose of 2 tablets
every 6 hours it is intended that legitimate pain patients will receive
effective analgesic effects and not be aware of the potential effects of niacin.
However, when a person swallows excess quantities of OxyADF Tablets, it is
intended that they will experience an unpleasant combination of symptoms,
including warmth or flushing, itching, sweating and/or chills, headache and
a
general feeling of discomfort. It is expected that these dysphoric symptoms
will
begin approximately 15 minutes after the excess dose is swallowed and
self-resolve approximately 90 minutes later. The Company does not expect that
the undesirable niacin effects will be “fool-proof” in discouraging
swallowing excessive
numbers of
OxyADF
Tablets. However, we anticipate
that
inclusion of niacin in OxyADF Tablets and other Aversion® Technology product
candidates will deter, to a certain degree, legitimate pain patients or
potential drug abusers from swallowing excess quantities of OxyADF
Tablets.
We
anticipate
that
most potential drug abusers or recreational drug users will seek alternative
opioid analgesic products that are generally much easier to abuse than OxyADF
Tablets, and do not have the potential to cause these undesirable niacin
effects. As described below, the Company has evaluated the effects of niacin
in
three phase II clinical studies in subjects with and without a history of opioid
abuse.
Expectations
for OxyADF Tablets Product Labeling
In
the
U.S., every product approved for commercialization pursuant to an NDA must
be
marketed in accordance with its FDA approved indications and associated product
labeling. The FDA has provided written guidance to the Company stating that
an
indication for abuse deterrence must be supported by data from two adequate
and
well-controlled clinical trials. The Company does not intend to seek an
indication for abuse deterrence for OxyADF Tablets. Instead, the Company is
seeking an indication for OxyADF Tablets for treatment of moderate to moderately
severe pain. The FDA has also provided written guidance to the Company stating
that language regarding abuse deterrence, which is supported by rigorous,
scientific data, may be placed into appropriate sections of the OxyADF Tablet
product label. In this regard, the Company intends to seek FDA approval of
language in the OxyADF Tablet product label describing the physical
characteristics of the product and likely results if attempts are made to
dissolve tablets in solvents for intravenous injection, and/or snort crushed
tablets, and/or swallow excessive numbers of tablets. The Company believes
this
product labeling strategy will provide a viable promotional platform for the
commercialization of OxyADF Tablets and other product candidates utilizing
Aversion® Technology. At this stage there can be no assurances that the
Company's product labeling strategy for OxyADF Tablets will be successful or
that FDA approved product labeling, if any, will provide a viable
commercialization platform.
19
OxyADF
Tablets Clinical Development Program: Completed and Planned Clinical
Studies
The
clinical
development program for OxyADF Tablets is summarized below. At this stage,
the
Company cannot provide any assurance
that FDA will not require additional clinical studies prior to their acceptance
for filing of a 505(b)(2) NDA submission for OxyADF Tablets.
OxyADF
Tablets Clinical Development Program
Clinical
Study Number
|
Clinical
Study Description
|
Status
|
|
||
Phase
I
|
||
AP-ADF-101
|
Niacin
dose-response in normal subjects
|
Final
study report complete
|
AP-ADF-104
|
Phase
I:
Bioequivalence to non
Aversion® Technology Reference Listed Drug
|
Final
study report complete. OxyADF tablets are bioequivalent to reference
listed drug
|
AP-ADF-106
|
Evaluate
effects of nasal snorting
|
Received
FDA written guidance for protocol design
|
AP-ADF-108
|
Single
dose pharmacokinetics
(dose
linearity
and food effect)
|
Received
FDA written guidance for protocol design
|
AP-ADF-109
|
Multi-dose
pharmacokinetics (dose linearity)
|
Received
FDA written guidance for protocol design
|
AP-ADF-110
|
Single
dose pharmacokinetics and bioavailability. Required if there is not
dose
linearity
|
Received
initial FDA written guidance for protocol design
|
|
||
Phase
II
|
||
AP-ADF-102
|
Relative
dislike of oxycodone HCl/niacin versus oxycodone alone in subjects
with a
history of opioid abuse
|
Subject
enrollment complete. Principal Investigator's report and data analysis
complete
Final
study report in progress
|
AP-ADF-103
|
Repeat
dose safety and tolerability in normal subjects
|
Final
study report complete
|
AP-ADF-107
|
Niacin
dose-response in normal subjects
|
Final
study report complete
|
|
||
Phase
III
|
||
AP-ADF-105
|
Pivotal
efficacy and safety
|
Received
FDA written guidance for protocol design. Special Protocol Assessment
requested
|
Summary
of OxyADF Tablets Phase II Study Designs, Status and
Results
Study
AP-ADF-102:
This
study is titled, "A Phase II Single-Center, Randomized, Double-Blind Study
in
Subjects with a History of Opioid Abuse to Evaluate the Dose-Response for
Flushing and Safety and Tolerability of Varying Doses of Niacin in Combination
with 40mg of an Opioid vs. 40mg of an Opioid Alone."
The
study objectives were 1) to determine the dose response for niacin-induced
flushing in male and female healthy, adult volunteers with a history of opioid
abuse when niacin is administered in combination with 40 mg oxycodone HCl,
2) to
evaluate the safety and tolerability of niacin-induced flushing following
varying niacin doses in combination with 40 mg oxycodone HCl in subjects with
a
history of opioid abuse; 3) to confirm the appropriate strength of niacin to
use
in an Aversion® Technology formulation of oxycodone HCl; 4) to determine whether
the flushing induced by niacin is of sufficient intensity to deter abuse in
a
population of subjects with a history of opioid abuse; and 5) to evaluate the
effect of food on niacin-induced flushing when niacin is administered in
combination with 40 mg oxycodone HCl.
20
This
study was a single-center, double-blind, randomized, placebo-controlled,
five-period crossover study conducted on an inpatient basis with 5 cohorts
of 5
subjects each. Twenty-five subjects (three female and twenty-two male) were
admitted for the study. One male subject completed the first drug condition
but
thereafter withdrew from the study stating personal reasons unrelated to the
study. Twenty-four subjects received a single dose of study drug every 48 hours
for 9 days. Each subject was randomized to a dosing sequence that included
doses
of niacin (0, 240, 480, and 600 mg) administered in combination with 40 mg
oxycodone HCl while the subjects were fasted on Days 1, 3, 5, and 7. On Day
9, a
dose of 600 mg niacin in combination with 40 mg oxycodone HCl was administered
following a standardized high-fat breakfast. Each dosing day, vital sign
measures and subjective and behavioral effects were assessed before dosing
and
at 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 12 hours after dosing. Vital signs included
systolic and diastolic blood pressure, heart rate, oral temperature and
respiratory rate. Subjective changes were measured by subject response to a
Drug
Rating Questionnaire (DRQS).
As an additional measure of subjective effects, subjects completed a 40 item
short form of an Addiction Research Inventory (ARCI) that yielded three scale
scores - the Morphine Benzedrine Group Scale (MBG), the LSD Specific Scale
(LSD)
and the Pentobarbital Chlorpromazine Alcohol Group Scale (PCAG). After
completion of the study, subjects responded to a Treatment Enjoyment Assessment
Questionnaire to select which of the treatments they would take again. Prior
to
initiating the study, the hypothesis was that the addition of niacin to
oxycodone would produce effects that are disliked by subjects with a history
of
opioid abuse. The maximum scale response to the question “How much do you
dislike the drug effect you are feeling now?” (i.e. the "Disliking Score"), was
designated as the primary efficacy variable. Statistical analysis (maximum
dislike response in comparison to 0 mg niacin) was conducted for DRQS, ARCI
scales and vital signs. Study results were as follows:
(1) |
In
the fasting state, all three doses of niacin [240mg, 480mg and 600mg]
in
combination with oxycodone 40mg produced significant (p ≤ .05) disliking
scores compared to oxycodone 40mg alone. The linear regression across
niacin dose was not significant. No other subjective measure was
significantly affected by the niacin addition to
oxycodone.
|
(2) |
The
high fat meal eliminated the niacin effect on oxycodone 40 mg. The
high
fat meal also delayed the time to oxycodone peak blood
levels.
|
(3) |
The
addition of niacin to oxycodone alters the subjective response to
oxycodone as indicated by the significant responses on the disliking
scale. This observation in conjunction with the results from the
Treatment
Enjoyment Questionnaire indicates that the addition of niacin reduces
the
attractiveness of oxycodone to opiate
abusers.
|
(4) |
There
were no serious adverse events. Niacin produced a dose related attenuation
of pupillary constriction, diastolic blood pressure increase and
probably
systolic blood pressure increase produced by oxycodone. The alterations
by
niacin on the vital sign responses to oxycodone 40 mg were minimal,
were
seen primarily with the 600 mg niacin dose and were not clinically
significant.
|
The
principal study investigator’s overall conclusion was that the results of this
pharmacodynamic study [Study AP-ADF-102] support the hypothesis that the
addition of niacin to oxycodone in a minimal ratio of 30 mg niacin to 5 mg
oxycodone is aversive when compared to oxycodone alone. The addition of niacin
does not alter the safety profile of oxycodone alone. The Company intends to
include the data and results from StudyAP-ADF-102 in its 505(b)(2) NDA
submission for OxyADF Tablets to the FDA.
21
Study
AP-ADF-103:
This
study is titled, "A Phase II Single-Center, Randomized, Double-Blind,
Multiple-Dose Study in Healthy Volunteers to Evaluate the Safety and
Tolerability of Niacin in Combination with 5 mg of an Opioid vs. 5 mg of an
Opioid Alone." To assess the safety and tolerability of OxyADF
(oxycodone/niacin) Tablets in comparison to oxycodone HCl tablets without
niacin, the Company conducted this Phase II single-center, randomized,
double-blind, multiple dose study in 66 healthy adult male and female
volunteers. Subjects were randomly assigned to one of three treatment groups
(22
subjects per treatment group). A run-in phase was conducted on an outpatient
basis for five days and included at-home dosing four times daily and adverse
event and tolerability assessments. The treatment phase followed the run-in
phase and was conducted on an inpatient basis for five days. The treatment
phase
included dosing with OxyADF
Tablets (with or without niacin) and post-treatment safety and tolerability
assessments. Efficacy (the tolerability of OxyADF) was evaluated with a Side
Effects and Symptoms Questionnaire (SESQ) and an OxyADF Tolerability Rating
Scale. Safety was evaluated by adverse events and clinical laboratory and vital
signs assessments were conducted periodically during the study. During the
run-in phase, comparable tolerability was demonstrated in subjects who took
OxyADF Tablets with and without niacin. The mean post-dose SESQ total score
during the run-in phase was very low in all groups (highest possible score
= 33;
Group results = 0.84 - 1.6) indicating that OxyADF was generally well-tolerated
when taken at recommended doses. During the treatment phase, 64% of subjects
in
Groups 2 and 3 (oxycodone HCl + niacin) reported side effects and symptoms
and
50% of subjects in Group 1 (oxycodone alone) reported side effects and symptoms.
Most of the side effects and symptoms observed during the treatment phase were
mild or moderate in severity. Irrespective of treatment group, approximately
three quarters of subjects reported either “no effect” or “easy to tolerate” on
the OxyADF Tolerability Rating Scale. Oxycodone HCl administered four times
a
day, with or without niacin, was determined to be
well
tolerated. Adverse events were reported by 77% of subjects throughout both
phases of the study. The majority of subjects (55%) reported adverse events
during the treatment phase that were considered mild in severity. No severe
adverse events were reported in any treatment group and no clinically important
trends over time were observed in any treatment group for vital signs
measurements (blood pressure, heart rate, and respiratory rate). The Company
intends to include the data and results from Study AP-ADF-103 in its 505(b)(2)
NDA submission to the FDA for OxyADF Tablets.
Study
AP-ADF-107: This
study is titled "A Phase II Single-Center, Randomized, Double-Blind Study in
Fasted and Non-Fasted Healthy Volunteers to Evaluate the Dose-Response for
Flushing and Safety and Tolerability of Escalating Doses of Niacin." The study
objective was to evaluate the dose-response for niacin-induced flushing, safety,
and tolerability of niacin in the OxyADF Tablet matrix (excluding oxycodone
HCl)
at various dose levels in both fasted and fed subjects. This trial was a Phase
II single-center, randomized, double-blind study in healthy, adult male and
female subjects. A total of 50 subjects were enrolled. The Treatment Phase
was
conducted on an inpatient basis and included study drug dosing and safety and
tolerability assessments. Each subject received eight doses of niacin (30,
60,
90, 120, 240, 360, 480, and 600 mg) and three doses of placebo administered
orally in tablet form on eleven separate days in a random sequence. Half of
the
subjects (n=25) took each dose of study drug following a standardized high-fat
breakfast consisting of two fried eggs, hash browns, two fried bacon strips,
toast, butter, and whole milk, and half (n=25) remained fasted for at least
2
hours after study drug administration. Subjects were discharged from the
Clinical Research Unit on Day 11, approximately 6 hours after the last dose
of
study drug administration.
Tolerability
was rated by subjects during the Treatment Phase using a Tolerability Rating
Scale (TRS) completed 3
hours
after each dose of study drug. Each subject’s overall reaction to the study drug
was recorded using the following 5-point scale: 0 = No effect; 1 = Easy to
tolerate; 2 = Mildly unpleasant, but tolerable; 3 = Unpleasant and difficult
to
tolerate; 4 = Intolerable and would never take again. The results showed a
clear
niacin dose-response relationship in both Fasted and Fed subjects as assessed
by
the 5-point TRS. The response ranged from little or no effect at low niacin
doses (30 to 90 mg) to more difficult and unpleasant symptoms at higher doses
of
niacin (>120 mg). With Fasted subjects, there was minimal or no effect of
niacin at doses of 30 to 60 mg, with ³96%
of
subjects reporting either “no effect” or “easy to tolerate”. Niacin was also
well tolerated at doses of 90 mg, with 86% of Fasted subjects reporting
either “no effect” or “easy to tolerate” and 14% reporting “mildly unpleasant,
but tolerable”. The absence of any notable effects at low doses suggests that
niacin will be well tolerated up to 60 mg per dose and will likely be well
tolerated at 90 mg per dose. As niacin doses escalated from 120 to 360 mg,
a
transition occurred resulting in a larger proportion of Fasted subjects (22%
to
73%) reporting mildly unpleasant, unpleasant, or intolerable effects. At doses
of 480 and 600 mg, most Fasted subjects (³86%)
reported mildly unpleasant, unpleasant, or intolerable effects. At least 40%
of
subjects dosed at 480 and 600 mg reported either “unpleasant and difficult
to tolerate” or “intolerable and would never take again”. The higher doses of
niacin clearly produced undesirable side effects. As anticipated, niacin effects
were mitigated by food. All Fed subjects (100%) receiving 30 to 240 mg niacin
reported “no effect” or “easy to tolerate”. Niacin was also generally well
tolerated at doses of 360 to 600 mg with most Fed subjects (³68%)
reporting “no effect” or “easy to tolerate”.
In
this
study there were no significant adverse events or discontinuations due to
treatment-emergent adverse events (TEAEs). None of the TEAEs reported were
severe in intensity. A clear niacin dose-response relationship was observed
in
the incidence of AEs. As expected, the most frequently reported TEAE in both
Fasted and Fed subjects was flushing. Flushing occurred more frequently in
Fasted subjects than in Fed subjects with higher incidence as the niacin dose
increased. The majority of Fasted subjects (54% to 88%) reported flushing at
doses of 240 to 600 mg; while the majority of Fed subjects (64%) reported
flushing only at a dose of 600 mg. Most of the events of flushing were moderate
in intensity. No other safety issues were apparent. The Company intends to
include the data and results from Study AP-ADF-107 in its 505(b)(2) NDA
submission to the FDA for OxyADF Tablets.
22
Additional
OxyADF Tablets Clinical
Studies
Planned
The
FDA
has requested that the Company complete certain additional clinical studies
for
OxyADF Tablets prior to accepting our 505(b)(2) NDA submission including, as
of
the date of this Report, the following:
Study
AP-ADF-105:
This
study is titled “A Phase III, Randomized, Double-blind, Placebo-controlled,
Multicenter, Repeat-dose Study of the Safety and Efficacy of OxyADF (oxycodone
HCl and niacin) Tablets versus Placebo for the Treatment of Acute, Moderate
to
Severe Postoperative Pain Following Bunionectomy Surgery in Adult Patients.”
This short term phase III study is planned to enroll approximately 400 patients
with moderate to severe pain following bunionectomy surgery. The
Company has submitted the study protocol to the FDA and requested a Special
Protocol Assessment (SPA). Clinical protocols for Phase III trials whose data
will form the primary basis for an efficacy claim are eligible for a SPA. A
SPA
from the FDA is an agreement that the Phase III trial protocol design, clinical
endpoints, and statistical analyses plan are acceptable to support regulatory
approval. A SPA is binding upon the FDA unless a substantial scientific issue
essential to determining safety or efficacy is identified after the testing
is
begun. The Company believes the completion of Study AP-ADF-105 is the critical
time and events path to 505(b)(2) NDA submission for OxyADF Tablets.
Study
AP-ADF-106:
This
will be a phase I clinical study, for use in product labeling, evaluating the
nasal irritating characteristics of crushed OxyADF Tablets (with and/or without
oxycodone HCl) anticipated to enroll 12-24 normal subjects.
Studies
AP-ADF-108, AP-ADF-109, and if necessary AP-ADF-110: These
will be phase I single dose or multi-dose pharmacokinetic studies anticipated
to
enroll approximately 25-50 normal subjects per study.
Estimated
Timing for submission of a 505(b)(2) NDA for OxyADF
Tablets
Estimating
the dates of initiation and completion of clinical studies and the costs to
complete development of the Company's product candidates, including OxyADF
Tablets, would be speculative and potentially misleading. The Company expects
to
reassess its future research and development plans pending review of data
received from development activities currently in progress and the availability
of cash resources to fund such development activities. The cost and pace of
future research and development activities are linked and subject to change. At
this stage there can be no assurance that any of the Company’s research and
development efforts, including those for OxyADF Tablets, will lead to a
505(b)(2) NDA submission or that if NDA submissions are made with the FDA,
that
any such submission will be accepted for filing or approved by the
FDA.
Results
of Operations for the Three Months Ended March 31, 2007 and March 31,
2006
The
Company is a specialty pharmaceutical development company engaged in development
of innovative Aversion®
(abuse
deterrent) Technology and related product candidates. To generate revenue,
the
Company plans to enter into development and commercialization agreements with
strategically focused pharmaceutical company partners (the "Partners") providing
that such Partners license product candidates utilizing the Company’s
Aversion®
Technology and further develop, register and commercialize multiple formulations
and strengths of such product candidates. The
Company had no revenues for the three months ended March 31, 2007 and 2006
and
relied upon bridge loans provided by its current primary shareholders to fund
operations and development activities.
Research
and Development Expenses
The
Company’s research and development expenses for the three months ended March 31,
2007 and 2006 were as follows (in thousands):
3
MONTHS ENDED 3/31/07
R&D
EXPENSES
|
3
MONTHS ENDED 3/31/06
R&D
EXPENSES
|
3
MONTHS ENDED
3/31/07
and 3/31/06
R&D
EXPENSES
CHANGE
($)
|
3
MONTHS ENDED
3/31/07
and 3/31/06
R&D
EXPENSES
CHANGE
(%)
|
$1,196
|
$1,506
|
($310)
|
(21%)
|
Research
and development expense in the three months
ended March 31, 2007 and 2006 consisted of development of 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 2007 and 2006 results are non-cash
stock-based compensation charges of $179 and $949, respectively. Excluding
the
stock-based compensation expense, there is a $460 increase in overall expenses
primarily attributable to initiating clinical study AP-ADF-102 in the first
quarter of 2006. The decrease in stock-compensation expense of $770 (related
to
the fair value of stock options and restricted stock units, net of expected
forfeitures, granted prior to 2006 which continue to vest and expense over
the
related employees requisite service periods), is due to the vesting method
used
for amortization. The fair value of the awards are being amortized using a
graded vesting method which treats the award as if the grant was a series of
awards rather than a single award and attributes a higher percentage of the
reported fair value to the earlier years than to the later years of the service
period.
23
Marketing
, General and Administrative Expenses
Marketing,
general and administrative expenses for the three months ended March 31, 2007
and 2006
were as
follows (in thousands):
3
MONTHS ENDED 3/31/07
MARKETING,
G&A EXPENSES
|
3
MONTHS ENDED 3/31/06
MARKETING,
G&A EXPENSES
|
3
MONTHS ENDED
3/31/07
and 3/31/06
MARKETING,
G&A EXPENSES
CHANGE
($)
|
3
MONTHS ENDED
3/31/07
and 3/31/06
MARKETING,
G&A EXPENSES
CHANGE
(%)
|
$778
|
$2,421
|
($1,643)
|
(68%)
|
During
the three months ended March 31, 2007, marketing expenses consisted of
Aversion®
Technology primary market research studies and payroll costs. The Company’s
general and administrative expenses primarily consisted of legal, audit and
other professional fees, corporate insurance, and payroll costs. Included in
the
2007 and 2006 results are non-cash stock-based compensation charges of $263
and
$1,873, respectively. Excluding the stock-based compensation expense, the
expenses are relatively unchanged between reporting periods. The decrease in
stock-compensation expense of $1,610 (related to the fair value of stock options
and restricted stock units, net of expected forfeitures, granted prior to 2006
which continue to vest and expense over the related employees requisite service
periods) is due to a nonrecurring $480 expense immediately recorded in February
2006 on the grant of restricted stock units to the Company’s independent
directors, and to the vesting method used for amortization. The fair value
of
the awards is being amortized using a graded vesting method which treats the
award as if the grant was a series of awards rather than a single award and
attributes a higher percentage of the reported fair value to the earlier years
than to the later years of the service period.
Interest
Expense, net of Interest Income
The
Company’s interest expense, net of interest income for the three months ended
March 31, 2007 and 2006 was as follows (in thousands):
3
MONTHS ENDED 3/31/07
INTEREST
EXPENSE, NET OF INTEREST INCOME
|
3
MONTHS ENDED 3/31/06
INTEREST
EXPENSE, NET OF INTEREST INCOME
|
3
MONTHS ENDED
3/31/07
and 3/31/06
INTEREST
EXPENSE, NET
OF
INTEREST INCOME
CHANGE
($)
|
3
MONTHS ENDED
3/31/07
and 3/31/06
INTEREST
EXPENSE, NET
OF
INTEREST INCOME
CHANGE
(%)
|
$362
|
$221
|
$141
|
64%
|
The
Company incurs interest at the prime interest rate plus 4.5%, payable quarterly
in common stock, on its $5.0 million Secured Term Note and incurs 10% interest,
payable quarterly, on its $9.1 million Secured Senior Convertible Bridge Term
Notes (“Bridge Loans”). Interest on such Bridge Loans through June 30, 2006 was
paid in cash. Commencing with interest due under such Bridge Loans at September
30, 2006, all such interest was paid in the Company’s common stock. The increase
in net interest expense in 2007 resulted from the addition of $4.1 million
of
Bridge Loans since March 31, 2006 and increases in the prime interest
rate.
In
addition to the net interest expense reflected
above, in 2007 the Company also incurred $1,692 of amortization expense related
to debt discounts recorded upon issuance of certain debt agreements in latter
2006. The 2006 period had no such expense.
24
Net
Loss
The
Company’s net loss for the three months ended March 31, 2007 and 2006 was as
follows (in thousands):
3
MONTHS ENDED 3/31/07
NET
LOSS
|
3
MONTHS ENDED 3/31/06
N
ET LOSS
|
3
MONTHS ENDED
3/31/07
and 3/31/06
NET
LOSS
CHANGE
($)
|
3
MONTHS ENDED
3/31/07
and 3/31/06
NET
LOSS
CHANGE
(%)
|
$9,159
|
$4,155
|
$5,004
|
120%
|
Included
in the net loss for the three months ended March 31, 2007 are non cash
stock-based compensation charges of $442 and $2,822
for the three months ended March 31, 2007 and 2006, respectively.
The
November and December 2006 issuances of Bridge Loans for an aggregate face
value
of $1,104 included an amended conversion feature which the Company valued at
an
aggregate of $1,034. This value was recorded as a liability with an offsetting
$1,025 debt discount (which was amortized over the term of the Bridge Loans)
and
$9 of issuance loss. However, as the debt was issued to shareholders who control
the Company, this loss was recorded as a non-cash deemed dividend rather than
effecting net loss. Additional issuances of $896 of Bridge Loans in January
and
February 2007 similarly had aggregate conversion feature value of $849 and
a
loss upon issuance of $3.
The
November 2006 amendment of the conversion feature on all of the then outstanding
Bridge Loans, coupled with the requirement under current accounting guidance
to
separate the value of the conversion feature from the debt, required the Company
to record the value of the amended conversion feature on that outstanding debt
as a liability and a loss on the modification of debt. The Company assigned
a
value of $19,951 to these conversion features at date of modification and
reflected that loss as non-cash deemed dividend.
Upon
revaluing the aggregate conversion features on all outstanding Bridge Loans
as
of March 30, 2007 (the date immediately before further amendment to the Bridge
Loans), the Company recorded the resulting increase in value as a $3,483 loss.
The increase in the Company’s common stock trading price from December 31, 2006
to March 30, 2007 resulted in the increase in the value of the conversion
liability. The Bridge Loan amendment on March 30, 2007 limited the conversion
price of the post-October 2006 loans to no lower than $0.21 per share. With
this
limit in place, the outstanding conversion feature no longer had to be reflected
as Company liabilities. As such, the Company recorded a $21,100 reclassification
of that liability to additional paid-in capital.
As
a
result of the November 2006 amendment to the Bridge Loans, the Company’s
outstanding common stock purchase warrants started being accounted for as
mark-to-market liabilities with a recorded value of $10,784 at December 31,
2006. Upon revaluing the warrants as of March 30, 2007 (the date immediately
before further amendment to the Bridge Loans), the Company recorded the
resulting increase in value as a $1,668 loss. The increase in the Company’s
common stock trading price from December 31, 2006 to March 30, 2007 resulted
in
the increase in the value of the warrant liability. The Bridge Loan amendment
on
March 30, 2007 limited the conversion price of the post-October 2006 loans
to no
lower than $0.21 per share. With this limit in place, the outstanding warrants
no longer had to be reflected as Company liabilities. As such, the Company
recorded a $12,300 reclassification of that liability to additional paid-in
capital.
Liquidity
and Capital Resources
At
March
31, 2007, the Company had unrestricted cash and cash equivalents of $0.5
million compared to $0.2 million at December 31, 2006. The Company had a working
capital deficit of $13.9 million at March 31, 2007 compared to a working capital
deficit of $28.6 million at December 31, 2006, with the decrease primarily
due
to the reclassification of $16.8 million conversion feature liabilities into
additional paid in capital, offset by an increase of $1.3 million of bridge
loans, both as discussed in Note 9 of this Report.
25
Commercial
Focus, Cash Reserves and Funding Requirements
As
of May
2, 2007, the Company had cash and cash equivalents of approximately $170,000.
Such cash reserves will be dedicated to the development of the Company's
Aversion®
Technology, the prosecution of the Company's patent applications relating to
the
Aversion®
Technology and for related operating expenses. The Company must rely on its
current cash reserves to fund the development of its Aversion®
Technology and related operating expenses. The Company's future sources of
revenue, if any, will be derived from contract signing fees, milestone payments
and royalties and/or profit sharing payments from licensees for the Company's
Aversion®
Technology.
The Company estimates that its current cash reserves, including the remaining
$600,000 bridge loan commitment under the March 2007 bridge loan amendment,
will
fund continued development of the Aversion®
Technology and related operating expenses through mid-June 2007. To fund further
operations and product development activities the Company must raise additional
financing, or enter into alliances or collaboration agreements with third
parties resulting in cash payments to the Company. The
Company is seeking to secure working capital providing gross proceeds to the
Company in the range of approximately $15 million to $20 million through the
private offering of the Company’s securities. The terms of any such securities
offering, including, without limitation, the type of equity securities (or
securities convertible into equity securities) and the price per share, have
not
been determined and will, in large part, be determined based upon negotiations
between the Company and prospective investors in such private offering. No
assurance can be given that the Company will be successful in obtaining any
such
financing or in securing collaborative agreements with third parties on
acceptable terms, if at all, or if secured, that such financing or collaborative
agreements will provide for payments to the Company sufficient to continue
to
fund operations. In the absence of such financing or third-party collaborative
agreements, the Company will be required to scale back or terminate operations
and/or seek protection under applicable bankruptcy laws. Even
assuming the Company is successful in securing additional sources of financing
to fund the continued development of the Aversion®
Technology, or enters into alliances or collaborative agreements relating to
the
Aversion®
Technology, there can be no assurance that the Company's development efforts
will result in commercially viable products. The Company's failure to
successfully develop the Aversion®
Technology in a timely manner, and to avoid infringing third-party patents
and
other intellectual property rights will have a material adverse impact on its
financial condition and results of operations.
In
view
of the matters described above, recoverability of a major portion of the
recorded asset amounts shown in the Company's accompanying consolidated balance
sheets is dependent upon continued operations of the Company, which in turn
are
dependent upon the Company's ability to meet its financing requirements on
a
continuing basis, to maintain present financing, and to succeed in its future
operations. The Company's financial statements do not include any adjustments
relating to the recoverability and classification of recorded asset amounts
or
amounts and classification of liabilities that might be necessary should the
Company be unable to continue in existence.
The
following table presents the Company's expected cash requirements for
contractual obligations outstanding as of March 31, 20007 (in
thousands):
Expected
cash payments on
contractual
obligations outstanding
at
March 31, 2007
|
Total
|
Due
in 2007
|
Due
in 2008
|
Due
Thereafter
|
|||||||||
Bridge
term notes, gross (2)
|
$
|
9,144
|
$
|
9,144
|
$
|
-
|
$
|
-
|
|||||
Interest
on fixed rate debt (1)
|
457
|
457
|
-
|
-
|
|||||||||
Term
note (2)
|
5,000
|
5,000
|
-
|
-
|
|||||||||
Capital
leases
|
26
|
19
|
7
|
-
|
|||||||||
Operating
leases
|
12
|
12
|
-
|
-
|
|||||||||
Employment
agreements
|
555
|
555
|
-
|
-
|
|||||||||
Total
contractual cash obligations
|
$
|
15,194
|
$
|
15,187
|
$
|
7
|
$
|
-
|
|||||
Expected
cash payments on
contractual
obligations entered into
subsequent
to March 31, 2007
|
Total
|
Due
in 2007
|
Due
in 2008
|
Due
Thereafter
|
|||||||||
Bridge
term notes, gross (2)
|
$
|
200
|
$
|
200
|
$
|
-
|
$
|
-
|
|||||
Interest
on fixed rate debt (1)
|
10
|
10
|
-
|
-
|
|||||||||
Total
contractual cash obligations
|
$
|
210
|
$
|
210
|
$
|
-
|
$
|
-
|
|||||
(1) |
At
the Company’s option, interest on the Company’s fixed rate Bridge Term
Notes is payable in either cash or Company common stock. Interest
on the
Company’s variable rate debt is payable in Company common stock (Note 9).
|
(2) |
To
the extent cash is not available to the Company to pay this near-term
debt
obligation upon maturity, the Company expects to negotiate with its
lenders to arrange for alternative means to settle the obligation,
including, without limitation, the possible extension of maturity
or
conversion into equity.
|
26
Critical
Accounting Policies
Note
A of
the Notes to Consolidated Financial Statements, in the Company’s 2006 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 that Annual Report are the same ones
applicable to 2007.
Item
4.
Controls and Procedures
Evaluation
of Disclosure Controls and Procedures. The
Company carried out an evaluation, under the supervision and with the
participation of the Company's management, including the Company's Chief
Executive Officer and Chief Financial Officer, of the effectiveness of the
design and operation of the Company's disclosure controls and procedures
pursuant to Exchange Act Rule 13a-14 as of the end of the period covered by
this
Report. Based upon that evaluation, the Chief Executive Officer and Chief
Financial Officer concluded that the Company's disclosure controls and
procedures are effective in timely alerting them to material information
relating to the Company (including its consolidated subsidiary) required to
be
included in the Company's periodic Securities and Exchange Commission filings.
No significant changes were made in the Company's internal controls or in other
factors that could significantly affect these controls subsequent to the date
of
their evaluation.
Changes
in Internal Control over Financial Reporting. There
was
no change in the Company's internal control over financial reporting that
occurred during the period covered by this Report that has materially affected,
or is reasonably likely to materially affect, the Company's internal control
over financial reporting.
PART
II
Item
1A.
Risk Factors Relating To The Company
There
are
no material changes in the Risk Factor disclosures contained in Item 1A of
the
Company's Annual Report on Form 10-K for the year ended December 31,
2006.
Item
2. Unregistered
Sale of Equity Securities and Use of Proceeds
Issuance
of Common Stock. During
the quarter ended March 31, 2007, the Company issued Common Stock in the amounts
of (i) 247,232
shares
as payment of $207,000 of
interest due March 31, 2007 on the Company’s Senior
Secured Convertible Bridge Term Notes,
(ii)
185,692 shares as payment of $157,000 of interest due March 31, 2007 on the
Company's Secured
Term Note and (iii) 165,335 shares for the cashless exercise of 410,092 common
stock purchase warrants.
Exemption
from Registration.
The
Company issued the above-described Common Stock in reliance upon the exemption
from registration provided by Section 4(2) of the Securities Act of 1933, as
amended and/or Regulation D promulgated under the Securities Act of 1933. Each
of the recipients of such shares represented to the Company that such holder
was
an accredited investor as defined in Rule 501(a) of the Securities Act of 1933
and that the securities issued pursuant thereto were being acquired for
investment purposes.
27
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.
|
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.
May 4, 2007 | ACURA PHARMACEUTICALS, INC. | |
|
|
|
By: | /s/ Andrew D. Reddick | |
Andrew D. Reddick | ||
President & Chief Executive Officer |
|
|
|
By: | /s/ Peter A. Clemens | |
Peter A. Clemens | ||
Senior VP & Chief Financial Officer |
28