(Mark
One)
|
|
x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT
OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31,
2007
|
Or
|
|
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the transition period from _____ to
_____
|
New
York
|
11-0853640
|
(State
or other jurisdiction of Incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
|
|
616
N. North Court, Suite 120, Palatine, Illinois
|
60067
|
(Address
of principal executive office)
|
(Zip
code)
|
PAGE
|
|||
|
|
PART
I
|
|
Item
1.
|
|
Business
|
3
|
Item
1A.
|
|
Risk
Factors
|
19
|
Item
1B.
|
|
Unresolved
Staff Comments
|
30
|
Item
2.
|
|
Properties
|
30
|
Item
3.
|
|
Legal
Proceedings
|
30
|
Item
4.
|
|
Submission
of Matters to a Vote of Security Holders
|
30
|
|
|
PART
II
|
|
Item
5.
|
|
Market
for Registrant's Common Equity and Related Stockholder Matters and
Issuer
Purchases of Equity Securities
|
30
|
Item
6.
|
|
Selected
Financial Data
|
31
|
Item
7.
|
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
32
|
Item
7A.
|
|
Quantitative
and Qualitative Disclosures About Market Risk
|
42
|
Item
8.
|
|
Financial
Statements and Supplementary Data
|
42
|
Item
9.
|
|
Changes
in and Disagreement with Accountants on Accounting and Financial
Disclosure
|
43
|
Item
9A.
|
|
Controls
and Procedures
|
43
|
Item
9B.
|
|
Other
Information
|
44
|
|
|
PART
III
|
|
Item
10.
|
|
Directors,
Executive Officers and Corporate Governance
|
44
|
Item
11.
|
|
Executive
Compensation
|
46
|
Item
12.
|
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
62
|
Item
13.
|
|
Certain
Relationships and Related Transactions, and Director
Independence
|
65
|
Item
14.
|
|
Principal
Accountant Fees and Services
|
67
|
|
|
PART
IV
|
|
Item
15.
|
|
Exhibits
and Financial Statement Schedules
|
68
|
|
|
Signatures
|
69
|
|
|
Index
to Financial Statements
|
F-1
|
·
|
research
and
development
of product candidates utilizing our Aversion
®
Technology;
|
·
|
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;
|
·
|
prosecution
of our patent applications relating to
Aversion
®
Technology with the United States Patent and Trademark Office (“USPTO”)
and foreign equivalents; and
|
·
|
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 FDA and other
regulatory authorities and commercialize such
products.
|
-
|
Capitalize
on our Experience and Expertise in the Research and Development of
Abuse
Deterrent Pharmaceutical Products
.
Our approach is to utilize existing active pharmaceutical ingredients
with
proven safety and efficacy profiles that have known potential for
abuse,
and develop new products utilizing our proprietary Aversion® (“abuse
deterrent”) Technology. We believe that in most cases the FDA’s
505(b)(2)
NDA approval process may be used with these product candidates. While
there can be no assurance, we believe the use of the 505(b)(2) NDA
approval process may allow for more efficient and timely approvals
as
compared to standard NDA filings
.
The 505(b)(2) NDA regulatory pathway is being utilized in the development
of Acurox™ Tablets, our lead product candidate utilizing Aversion®
Technology. In addition to Acurox™ Tablets, as of the date of this Report
we are engaged in the development of several additional product candidates
incorporating Aversion® Technology, including hydrocodone bitartrate with
acetaminophen tablets (marketed generically and by others under the
brand
names Vicodin®, Lortab®, and Lorcet®), hydromorphone HCl tablets (marketed
generically and by Abbott Laboratories under the brand name Dilaudid®) and
oxycodone HCl with acetaminophen (marketed generically and by others
under
the brand names of Percocet®, Tylox®, Endocet ®, and Roxicet®). We expect
to file an IND for our second Aversion® Technology opioid product
candidate in the first half of 2008.
|
-
|
Maximize
Commercial Value of our Product Candidates Through Out-Licensing
to
Strategically Focused Pharmaceutical Partners.
On
October 30, 2007, we and King Pharmaceuticals Research and Development,
Inc. (“King”), a wholly-owned subsidiary of King Pharmaceuticals, Inc.,
entered into a License, Development and Commercialization Agreement
(the
“King Agreement”) to develop and commercialize in the United States,
Canada and Mexico (the "King Territory") opioid analgesic products
utilizing Aversion® Technology including Acurox™ Tablets. We believe
opportunities exist to enter into similar agreements with other commercial
partners for these same opioid products outside the King Territory
and in
the United States and worldwide for developing additional Aversion®
Technology product candidates for other abuseable drugs including
tranquilizers, stimulants and sedatives. By partnering with strategically
focused companies with expertise and infrastructure in commercialization
of pharmaceuticals, we are able to leverage our expertise, intellectual
property rights and Aversion® Technology without the need to build costly
sales and manufacturing infrastructure. We anticipate that our future
revenue, if any, will be derived from milestone and royalty payments
related to the commercialization of products utilizing our Aversion®
Technology.
|
-
|
Expand
the Aversion® Technology Intellectual Property Portfolio.
We
believe our patent granted by the United States Patent and Trademark
Office ("USPTO") in April 2007 for Aversion® Technology provides
protection in the U.S. against potential generic product competition
through the year 2023 and is a key element for the appeal of our
product
candidates to King for opioid product candidates and other potential
commercial partners for non-opioid product candidates. We have filed
additional patent applications with the USPTO which, if issued, will
compliment and broaden the scope of our granted patent claims. In
addition, we have filed corresponding Aversion® Technology patent
applications internationally. All of the Aversion® Technology intellectual
property, including all pending and issued patents was developed
internally by the Company and as of the date of this Report we believe
no
enabling licenses from others will be required.
|
-
|
Remain
focused on Research, Development and Achieving Proof of Concept for
Product Candidates Incorporating the
Aversion®
Technology while Minimizing Internal Fixed Costs through Outsourcing
High
Fixed Cost Elements of the Development Process.
We
maintain a streamlined corporate infrastructure focused on:
|
·
|
selection,
formulation development, laboratory evaluation, manufacture, quality
assurance and stability testing of certain finished dosage form product
candidates;
|
·
|
development
and prosecution of our patent applications; and
|
·
|
negotiation
and execution of license and development agreements with strategically
focused pharmaceutical partners. While we expect to expand our internal
staff to enable us to more rapidly develop multiple product candidates,
as
of the date of this Report we have only 14 employees, 9 of whom are
engaged in the research, development and manufacture of product candidates
utilizing the Aversion® Technology. We contract with 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 Acurox™ Tablets and
other Aversion® product candidates under our direction. By outsourcing the
high fixed cost elements of our product development process, we believe
that we substantially reduce fixed overhead and capital investment
and
thereby reduce our business risk.
|
-
|
Mild
burning and irritation
–if
the tablets are crushed and the prospective drug abuser attempts
to snort
the crushed tablets a mild burning and irritation of the nasal passages
is
expected
to
occur
|
-
|
Viscous
gel traps active ingredient
–when
Acurox™ Tablets are crushed and snorted, we expect the moisture in the
nasal passages will form a viscous gel with the crushed tablet powder
thereby trapping the oxycodone in the gel and reducing the amount
of
oxycodone available for absorption through the lining of the nasal
passages
|
-
|
Gelatinous
mass
–
we believe 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
|
Opioid
Active Ingredients
(Generic
Names)
|
Frequently
Prescribed Opioid Analgesics
(Common
Brand Names)
|
|
Oxycodone
|
Percocet®,
OxyContin®, Roxicet®, Tylox®, Endocet®
|
|
Hydrocodone
|
Vicodin®,
Lortab®, Lorcet®
|
|
Morphine
|
Avinza®,
Kadian®, MSContin®
|
|
Hydromorphone
|
Dilaudid®
|
|
Codeine
|
Tylenol®
with Codeine
|
|
Tramadol
|
Ultram®,
Ultram® ER, Ultracet®
|
|
Propoxyphene
|
Darvon®,
Darvocet®
|
Category
|
During
Lifetime
(millions)
|
During
Past
Year
(millions)
|
Frequently
Prescribed
(Common
Brand Names)
|
|||
CNS
Depressants
|
30.1
|
6.0
|
Valium®,
Xanax®, Halcion®, Klonopin®, Ativan®, Nembutal®
|
|||
Stimulants
|
20.1
|
3.4
|
Dexadrine®,
Adderall®, Ritalin®, Concerta®
|
Technical
and Pre-Clinical Development
|
Status
and Expectations
|
|
Formulation
development
|
Complete
|
|
Pilot
bioequivalence study
|
Complete
|
|
Pivotal
oxycodone laboratory extraction study
|
Complete
(results summarized in this Report)
|
|
Tablet
stability for NDA submission
|
Testing
in process. 24 month real time data demonstrates stability acceptable
for
NDA submission
|
|
Toxicology
studies
|
Not
required per FDA written guidance to
us
|
Regulatory
Affairs
|
Status
and Expectations
|
|
Investigational
New Drug Application (IND)
|
Active
|
|
End
of Phase II meeting with FDA
|
Complete
|
|
Factorial
design clinical studies
|
Not
required per FDA written guidance to us
|
|
Phase
III pivotal clinical trial
|
A
single phase III efficacy and safety trial is required per FDA written
guidance to us.
|
|
Type
of regulatory submission for U.S. regulatory approval and commercial
distribution in the U.S.
|
Acurox™
Tablets are eligible for submission as a 505(b)(2) NDA per FDA written
guidance to us
|
|
505(b)(2)
NDA submission
|
Anticipate
submission H2-08
|
Approximate
laboratory time
|
|||||||
Product
Tested,
|
required
to produce a form
|
Difficulty
Rating
|
|||||
Oxycodone
HCl Strength
and
Product Supplier
|
suitable
for intravenous
injection
|
Extraction
Scheme
and
Yield
|
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
|
||||
Acurox
Tablets
8
x
5/30mg tablets
Acura
Pharmaceuticals
|
355
minutes
with
no success
|
23
Steps
~0%
Yield
|
10
|
Clinical
Studies to Evaluate Pharmacokinetics in Normal
Subjects
|
Status and Expectations | |||
AP-ADF-104
|
Phase
I
:
Bioequivalence to non
Aversion® Technology Reference Listed Drug
|
Final
study report complete. Acurox™ Tablets are bioequivalent to the Reference
Listed Drug
|
||
AP-ADF-108
|
Phase
I: Single dose
linearity
and food effect
|
Summary
report complete.
Acurox
Tablets demonstrate single dose linearity. Absorption is delayed
by
food.
|
||
AP-ADF-109
|
Phase
I: Multi-dose linearity
|
Expect
subject enrollment Q1-08
|
||
AP-ADF-110
|
Phase
I: Required only if there is not dose linearity in Study AP-ADF-108
and
Study AP-ADF-109
|
As
of the date of this Report, we do not anticipate this study will
be
required
|
Clinical
Studies to Evaluate Tolerability of Nasal Snorting and
Excess
Oral
Doses in Subjects with a History of Opioid Abuse
|
Status
and Expectations
|
|||
AP-ADF-106
|
Phase
I: Evaluate effects of nasal snorting in subjects with a history
of
snorting and nasal drug abuse
|
Expect
subject enrollment Q2-08
|
||
AP-ADF-102
|
Phase
II: Evaluate relative dislike of oxycodone HCl/niacin versus oxycodone
HCl
alone
|
Final
study report complete
Refer
to summary in this Report
|
||
AP-ADF-111
|
Phase
II: Evaluate abuse liability of oxycodone HCl/niacin versus oxycodone
HCl
alone
|
Expect
subject enrollment Q1 and Q2-08
|
(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.
|
Clinical
Study to Evaluate Efficacy and Safety in Patients with Acute Moderate
to
Severe Pain
|
Status
and Expectations
|
||
AP-ADF-105
|
Phase
III: Pivotal efficacy and safety
|
|
Special
Protocol Assessment (SPA) agreed by FDA. Patient enrollment in progress.
Anticipate final clinical study report in
H2-08
|
Immediate Release Products
|
Extended Release Products
|
||
Dispensed
Rx’s
1
|
221
Million
|
14
Million
|
|
Ratio
of Dispensed Rx’s
1
|
16:1
|
||
Ratio
of Abuse
2
|
10:1
|
||
Estimated
Ratio of $ Market Potential
3
|
4:1
|
||
Identified
Competitors
|
Acura in collaboration with King
|
1.
Alpharma
2.
Pain
Therapeutics
3.
Purdue
4.
Endo
5.
Elite
6.
Neuromed
7.
Collegium
|
NAME
|
AGE
|
POSITION
|
||||
Andrew
D. Reddick
|
55
|
President,
Chief Executive Officer and Director
|
||||
Ron
J. Spivey
|
61
|
Senior
Vice President and Chief Scientific Officer
|
||||
Peter
A. Clemens
|
55
|
Senior
Vice President, Chief Financial Officer and Secretary
|
||||
James
F. Emigh
|
52
|
Vice
President of Marketing and Administration
|
||||
Robert
A. Seiser
|
44
|
Vice
President, Corporate Controller and Treasurer
|
||||
Bruce
F. Wesson
|
65
|
Director
|
||||
William
A. Sumner
|
70
|
Director
|
||||
Richard
J. Markham
|
57
|
Director
|
||||
William
G. Skelly
|
56
|
Director
|
||||
Immanuel
Thangaraj
|
37
|
Director
|
||||
George
K. Ross
|
66
|
Director
|
·
|
the
relative advantages and disadvantages of our Aversion® Technology compared
to competitive products;
|
·
|
the
relative timing to commercial launch of products utilizing our Aversion®
Technology compared to competitive products;
|
·
|
the
relative safety and efficacy of products incorporating our Aversion®
Technology compared to competitive products; and
|
·
|
the
willingness of third party payors to reimburse for or otherwise pay
for
products incorporating our Aversion®
Technology.
|
·
|
Regulatory
authorities may withdraw their approvals of such products;
|
·
|
We
or our licensees may be required to reformulate our products;
|
·
|
We
or our licensees may have to recall the affected products from the
market
and may not be able to introduce them onto the market;
|
·
|
Our
reputation in the marketplace may suffer; and
|
·
|
We
may become the target of lawsuits, including class actions suits.
|
·
|
litigation
or other proceedings we may initiate against third parties to enforce
our
patent rights or other intellectual property rights;
|
·
|
litigation
or other proceedings we may initiate against third parties to seek
to
invalidate the patents held by such third parties or to obtain a
judgment
that our product candidates do not infringe such third parties’ patents;
|
·
|
if
our competitors file patent applications that claim technology also
claimed by us, we may participate in interference or opposition
proceedings to determine the priority of invention; and
|
·
|
if
third parties initiate litigation claiming that our product candidates
infringe their patent or other intellectual property rights, we will
need
to defend against such proceedings.
|
PERIOD
|
Bid
Prices
|
||||||
|
High
$
|
Low
$
|
|||||
2006 Fiscal Year | |||||||
First
Quarter
|
9.10
|
2.50
|
|||||
Second
Quarter
|
7.90
|
5.00
|
|||||
Third
Quarter
|
10.90
|
5.90
|
|||||
Fourth
Quarter
|
9.20
|
5.60
|
|||||
2007
Fiscal Year
|
|||||||
First
Quarter
|
9.50
|
6.90
|
|||||
Second
Quarter
|
11.50
|
7.60
|
|||||
Third
Quarter
|
28.40
|
9.30
|
|||||
Fourth
Quarter
|
22.40
|
6.00
|
|||||
2008
Fiscal Year
|
|||||||
First
Quarter (through February 1, 2008)
|
8.60
|
5.90
|
PERIOD
|
Sale
Prices
|
||||||
|
High
$
|
Low
$
|
|||||
2008
Fiscal Year
|
|||||||
First
Quarter (from February 4, 2008 through February 29,
2008)
|
|
|
10.50
|
7.53
|
OPERATING
DATA
(in
thousands)
except per share data
|
2007
|
2006
|
2005
|
2004
|
2003
|
|||||||||||
Net
revenues
|
$
|
6,404
|
—
|
—
|
$
|
838
|
$
|
5,750
|
||||||||
Operating
Costs:
|
||||||||||||||||
Cost
of manufacturing
|
—
|
—
|
—
|
1,435
|
11,705
|
|||||||||||
Research
and development
|
7,169
|
5,172
|
6,265
|
4,130
|
1,460
|
|||||||||||
Selling,
marketing, general and administrative expenses
|
4,141
|
5,654
|
5,296
|
5,238
|
7,903
|
|||||||||||
Plant
shutdown costs
|
—
|
—
|
—
|
—
|
1,926
|
|||||||||||
Interest
expense
|
(1,207
|
)
|
(1,140
|
)
|
(636
|
)
|
(2,962
|
(6,001
|
)
|
|||||||
Interest
income
|
268
|
18
|
36
|
59
|
25
|
|||||||||||
Write-off
of debt discount and deferred private debt offering costs
|
—
|
—
|
—
|
(41,807
|
)
|
—
|
||||||||||
Amortization
of debt discount and deferred private debt offering costs
|
(2,700
|
)
|
(183
|
)
|
—
|
(30,684
|
)
|
(24,771
|
||||||||
Gain
on debt restructuring
|
—
|
—
|
—
|
12,401
|
—
|
|||||||||||
(Loss)
Gain on fair value change of conversion features
|
(3,483
|
)
|
4,235
|
—
|
—
|
—
|
||||||||||
(Loss)
Gain on fair value change of common stock warrants
|
(1,905
|
)
|
2,164
|
—
|
—
|
—
|
||||||||||
(Loss)
gain on asset disposals
|
22
|
(22
|
)
|
81
|
2,359
|
—
|
||||||||||
Other
(expense) income
|
(3
|
)
|
(213
|
)
|
5
|
603
|
464
|
|||||||||
Loss
before income tax benefit
|
(13,914
|
)
|
(5,967
|
)
|
(12,075
|
)
|
(69,996
|
)
|
(48,455
|
)
|
||||||
Income
tax benefit
|
9,600
|
—
|
—
|
—
|
—
|
|||||||||||
Net
loss
|
$
|
(4,314
|
)
|
$
|
(5,967
|
)
|
$
|
(12,075
|
)
|
$
|
(69,996
|
)
|
$
|
(48,455
|
)
|
|
Basic
and diluted loss per common share applicable to common
stockholders
|
$
|
(0.11
|
)
|
$
|
(0.75
|
)
|
$
|
(1.81
|
)
|
$
|
(32.00
|
)
|
$
|
(22.80
|
)
|
|
Weighted
average number of outstanding common shares
|
39,157
|
34,496
|
6,680
|
2,186
|
2,123
|
BALANCE
SHEET DATA
(3)
(in
thousands)
|
2007
|
2006
|
2005
|
2004
|
2003
|
|||||||||||
Working
capital (deficiency)
|
$
|
22,306
|
$
|
(28,641
|
)
|
$
|
(2,478
|
)
|
$
|
2,423
|
$
|
(3,770
|
)
|
|||
Total
assets
|
45,628
|
1,619
|
1,792
|
4,967
|
6,622
|
|||||||||||
Total
debt, net (2)
|
—
|
28,787
|
7,613
|
5,093
|
53,142
|
|||||||||||
Total
liabilities
|
26,908
|
39,899
|
7,954
|
6,052
|
58,689
|
|||||||||||
Accumulated
deficit
|
(321,860
|
)
|
(317,543
|
)
|
(291,616
|
)
|
(279,541
|
)
|
(209,546
|
)
|
||||||
Stockholders'
equity (deficit)
|
18,720
|
(38,280
|
)
|
$
|
(6,162
|
)
|
$
|
(1,085
|
)
|
$
|
(52,067
|
)
|
(1)
Reflects the impact of significant corporate and financing restructuring
in 2004 as described in Notes C and F to the consolidated financial
statements.
|
(2)
Includes the estimated fair value of conversion features of convertible
debt outstanding as of December 31, 2006.
|
(3)
Reflects impact of $30 million received from King in December, 2007
as
described in Notes B and F to the consolidated financial
statements.
|
·
|
research
and
development
of product candidates utilizing our Aversion
®
Technology;
|
·
|
manufacture,
quality assurance testing and release, and stability studies of clinical
trial supplies and NDA submission batches of certain finished dosage
form
product candidates utilizing Aversion
®
Technology;
|
·
|
prosecution
of our patent applications relating to
Aversion
®
Technology with the United States Patent and Trademark Office (“USPTO”)
and foreign equivalents; and
|
·
|
negotiation
and execution of license and development agreements with pharmaceutical
company partners providing that such licensees will further develop
certain finished dosage product candidates utilizing the
Aversion
®
Technology and file for regulatory approval with the FDA and other
regulatory authorities and commercialize such
products.
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
2007
|
2006
|
Dollars
|
%
|
||||||||||
Revenue –
Program fee revenue
|
$
|
3,427
|
—
|
$
|
3,427
|
N/A
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
|
|
2007
|
|
2006
|
|
Dollars
|
|
%
|
|||||
Revenue –
Collaboration fee revenue
|
$
|
2,977
|
—
|
$
|
2,977
|
N/A
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
2007
|
2006
|
Dollars
|
%
|
||||||||||
Research
and development expenses
|
$
|
7,169
|
$
|
5,172
|
$
|
1,997
|
38
|
%
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
2007
|
2006
|
Dollars
|
%
|
||||||||||
Marketing,
general & administrative expenses
|
4,141
|
$
|
5,654
|
$
|
(1,513
|
)
|
(26
|
)%
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
2007
|
2006
|
Dollars
|
%
|
||||||||||
Interest
expense, net of interest income
|
$
|
939
|
$
|
1,122
|
$
|
(183
|
)
|
(16
|
)%
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
|
|
|
2007
|
|
|
2006
|
|
|
Dollars
|
|
|
%
|
|
Net
loss
|
$
|
4,314
|
$
|
5,967
|
$
|
(1,653
|
)
|
(27
|
)%
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
2006
|
2005
|
Dollars
|
%
|
||||||||||
Research
and development expenses
|
$
|
5,172
|
$
|
6,265
|
$
|
(1,093
|
)
|
(17
|
)%
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
2006
|
2005
|
Dollars
|
%
|
||||||||||
Marketing,
general and administrative expenses
|
$
|
5,654
|
$
|
5,296
|
$
|
358
|
7
|
%
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Interest
expense, net of interest income
|
$
|
1,122
|
$
|
600
|
$
|
522
|
87
|
%
|
($
in thousands):
|
Year
Ended December 31,
|
Change
|
|||||||||||
2006
|
2005
|
2006
|
2005
|
||||||||||
Net
loss
|
$
|
5,967
|
$
|
12,075
|
$ |
(6,108
|
)
|
(51
|
)%
|
1
Expected
to be reimbursed to us by King under the provisions of the King
Agreement.
|
·
|
Pertain
to the maintenance of records that in reasonable detail accurately
and
fairly reflect the transactions and disposition of our
assets;
|
·
|
Provide
reasonable assurance that transactions are recorded as necessary
to permit
preparation of financial statements in accordance with generally
accepted
accounting principles, and that our receipts and expenditures are
being
made only in accordance with authorizations of our management and
directors; and
|
·
|
Provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of our assets that could
have
a material effect on the financial statements.
|
Name and
Principal
Position
|
Year
|
Base
Salary
($)
|
Bonus
($)
|
Stock
Awards
1
($)
|
Option
Awards
2
($)
|
Total
($)
|
|||||||||||||
Andrew
D. Reddick
|
2006
|
300,000
|
—
|
1,375,000
|
$
|
77,000
|
1,752,000
|
||||||||||||
President
& CEO
|
2007
|
300,000
|
850,000
|
264,000
|
0
|
1,414,000
|
|||||||||||||
Peter
A. Clemens
|
2006
|
180,000
|
—
|
733,000
|
23,000
|
936,000
|
|||||||||||||
SVP
& CFO
|
2007
|
180,000
|
180,000
|
141,000
|
11,000
|
512,000
|
|||||||||||||
Ron
J. Spivey
|
2006
|
260,000
|
—
|
1,110,000
|
166,000
|
1,536,000
|
|||||||||||||
SVP
and Chief Scientific Officer
|
2007
|
260,000
|
650,000
|
211,000
|
0
|
1,121,000
|
|||||||||||||
James
F. Emigh
|
2006
|
140,000
|
—
|
229,000
|
16,000
|
385,000
|
|||||||||||||
VP,
Marketing & Administration
|
2007
|
140,000
|
140,000
|
44,000
|
7,000
|
331,000
|
|||||||||||||
Robert
A. Seiser
|
2006
|
133,000
|
—
|
275,000
|
16,000
|
424,000
|
|||||||||||||
VP,
Corporate Controller & Treasurer
|
2007
|
133,000
|
140,000
|
53,000
|
7,000
|
333,000
|
Vesting of
All Options
|
Exercisability of Options not
subject to Section 409A
|
Exercisability of Options Subject
to Section 409A
|
||||
Termination
due to Death
|
No
additional vesting
|
Vested
options immediately exercisable for one year following termination
|
Vested
options immediately exercisable for the lesser of (a) one year following
termination or (b) the last day of the year in which they become
exercisable
|
|||
Termination
by Company Without Cause or by Employee for Good Reason or following
Change of Control (not qualifying under Section 409A)
|
All
options fully vest
|
Vested
options immediately exercisable for one year following
termination
|
Vested
options exercisable commencing six months after termination for the
lesser
of (a) one year following termination or (b) the last day of the
year in
which they become exercisable
|
|||
Termination
due to Disability
|
No
additional vesting
|
Vested
options immediately exercisable for one year following
termination
|
Vested
options exercisable commencing six months after termination for the
lesser
of (a) one year following termination or (b) the last day of the
year in
which they become exercisable
|
|||
Termination
by the Company for Cause or by executive other than for Good
Reason
|
No
additional vesting
|
Vested
options immediately exercisable for 40 days following
termination
|
Vested
options exercisable commencing six months after termination for the
lesser
of (a) 40 days thereafter or (b) the last day of the calendar year
in
which they first become exercisable
|
|||
Change
of Control, Qualifying under Section 409A
|
Options
fully vest
|
Vested
options immediately exercisable
|
Vested
options exercisable upon Change of Control qualifying under Section
409A
during the year in which the Change of Control occurs
|
Option
Awards
|
|||||||||||||
Name
|
Number
of
Securities
Underlying
Unexercised Options (#) Exercisable |
Number
of
Securities Underlying Unexercised Options (#) Unexercisable |
Option
Exercise Price
($)
|
Option
Expiration Date |
|||||||||
Andrew
D.
Reddick
|
875,000
|
—
|
$
|
1.30
|
08/12/2014
|
||||||||
Peter
A. Clemens
|
30,000
10,000
12,500
10,000
28,125
|
—
—
—
—
9,375
|
$
$
$
$
$
|
23.75
11.25
18.75
11.125
1.30
|
02/19/2008
03/08/2009
02/17/2010
06/29/2010
03/09/2014
|
||||||||
Ron
J. Spivey
|
300,000
400,000
|
—
|
$
$
|
1.30
1.30
|
04/15/2014
12/09/2015
|
||||||||
Robert
A. Seiser
|
4,000
1,600
3,000
4,000
2,500
18,675
|
—
—
—
—
—
6,225
|
$
$
$
$
$
$
|
25.00
11.25
18.75
11.125
24.60
1.30
|
05/29/2008
03/08/2009
02/17/2010
06/29/2010
11/15/2011
03/09/2014
|
||||||||
James
F. Emigh
|
1,000
1,000
1,600
5,000
4,000
2,500
18,675
|
—
—
—
—
—
—
6,225
|
$
$
$
$
$
$
$
|
25.00
15.00
11.25
18.75
11.125
24.60
1.30
|
05/29/2008
10/13/2008
03/08/2009
02/17/2010
06/29/2010
11/15/2011
03/09/2014
|
Stock
Awards
|
|||||||
Name
|
Number
of Shares Vested (#)
(1)
|
Value
Realized on Vesting
($)
(2)
|
|||||
Andrew
D. Reddick
|
275,000
|
$
|
3,331,625
|
||||
Peter
A. Clemens
|
146,667
|
1,776,859
|
|||||
Ron
J. Spivey
|
220,000
|
2,665,300
|
|||||
James
F. Emigh
|
45,833
|
555,267
|
|||||
Robert
A. Seiser
|
55,000
|
666,325
|
Plan
Category
|
Number
Of Securities
to
Be Issued Upon
Exercise of Outstanding Options, Warrants and Rights (a) |
Weighted-Average
Exercise Price of Outstanding Options, Warrants and Rights (b) |
Number
of Securities
Remaining Available for Future Issuance Under Equity Compensation Plans
(Excluding
Securities
Reflected in Column(a) (c) |
|||||||
Stock
Option Equity Compensation Plans Approved by Security
Holders
|
1,858,499
|
$
|
2.53
|
102,666
|
||||||
Stock
Option Equity Compensation Plans Not Approved by Security
Holders
|
0
|
0
|
0
|
|||||||
Restricted
Stock Unit Equity Compensation Plans Approved by Security
Holders
|
2,950,000
|
0.01
|
50,000
|
|||||||
Restricted
Stock Unit Equity Compensation Plans Not Approved by Security
Holders
|
0
|
0
|
0
|
|||||||
TOTAL
|
4,808,499
|
$
|
0.99
|
152,666
|
Triggering
Event |
Executive
|
Severance
|
Bonus
|
Value
of
Options
Vesting
(4)
|
Medical,
Dental, Health, Disability and Life Insurance Benefits |
Total
(7) |
||||||
Termination
by Company without Cause or by
|
Andrew D. Reddick
|
300,000
|
(1)(8) |
—
|
(3) |
|
(5)
|
26,270
|
(6) |
326,270
|
||
Employee for Good Reason or after a |
Ron J. Spivey
|
260,000
|
(1)(9) |
—
|
(3) |
|
(5)
|
7,875
|
(6) |
267,875
|
||
Change of Control |
Peter A. Clemens
|
360,000
|
(2)(10) |
—
|
(3) |
666
|
52,540
|
(11) |
413,206
|
|||
Termination
for
|
Andrew D. Reddick
|
—
|
—
|
(3) |
—
|
—
|
—
|
|||||
Death |
Ron J. Spivey
|
—
|
—
|
—
|
—
|
—
|
||||||
Peter A. Clemens
|
—
|
—
|
—
|
—
|
—
|
|||||||
Termination
for
|
Andrew D. Reddick
|
—
|
—
|
(3) |
—
|
—
|
—
|
|||||
Disability |
Ron J. Spivey
|
—
|
—
|
—
|
—
|
—
|
||||||
Peter A. Clemens
|
—
|
—
|
—
|
—
|
—
|
|||||||
Termination
|
Andrew D. Reddick
|
—
|
—
|
—
|
—
|
—
|
||||||
with |
Ron J. Spivey
|
—
|
—
|
—
|
—
|
—
|
||||||
Cause |
Peter A. Clemens
|
—
|
—
|
—
|
—
|
—
|
||||||
Change
of Control
|
Andrew D. Reddick
|
—
|
—
|
(5)
|
—
|
—
|
||||||
Without |
Ron J. Spivey
|
—
|
—
|
|
(5)
|
—
|
—
|
|||||
Termination |
Peter A. Clemens
|
—
|
—
|
666
|
—
|
666
|
Director
|
Fees
Earned
or Paid in Cash ($) |
Stock
Awards
($)
(1)
|
Option
Awards
($)
(2)
|
Total
($)
|
|||||||||
William
G. Skelly
|
11,500
|
—
|
—
|
11,500
|
|||||||||
William
A. Sumner
|
12,000
|
—
|
—
|
12,000
|
|||||||||
Bruce
F. Wesson
|
5,250
|
—
|
—
|
5,250
|
|||||||||
Richard
J. Markham
|
6,250
|
—
|
—
|
6,250
|
|||||||||
Immanuel
Thangaraj
|
|
(3)
|
—
|
—
|
—
|
NAME
OF BENEFICIAL OWNER
|
AMOUNT
OWNED
|
PERCENT
OF
CLASS
(1)
|
|||||
GCE
Holdings LLC,
c/o
Galen Partners III,
L.P.
680
Washington Boulevard,
Stamford, CT 06901
|
34,564,956
|
(2)
|
77.7
|
%
|
|||
Vivo
Ventures Fund VI, L.P.
575
High St, Suite 201
Palo
Alto, CA 9430131
|
2,450,000
|
(3)
|
5.7
|
%
|
|||
Andrew
D. Reddick
|
875,000
|
(4)
|
2.0
|
%
|
|||
Ron
J. Spivey
|
700,000
|
(5)
|
1.6
|
%
|
|||
William
G. Skelly
|
33,333
|
(6)
|
*
|
||||
Bruce
F. Wesson
|
—
|
(2)(7)
|
*
|
||||
William
A. Sumner
|
24,000
|
(8)
|
*
|
||||
Peter
A. Clemens
|
105,080
|
(9)
|
*
|
||||
Richard
J. Markham
|
—
|
(2)(10)
|
*
|
||||
Immanuel
Thangaraj
|
—
|
(2)(11)
|
*
|
||||
Robert
A. Seiser
|
40,000
|
(12)
|
*
|
||||
James
F. Emigh
|
44,500
|
(13)
|
*
|
||||
George
K. Ross
|
5,000
|
(14)
|
*
|
||||
All
Officers and Directors as a Group (11 persons)
|
1,826,913
|
(15)
|
4.1
|
%
|
(1) |
Shows
percentage ownership assuming (i) such party converts all of its
currently
convertible securities or securities convertible within 60 days of
February 1, 2008 into the Company's common stock, and (ii) no other
Company securityholder converts any of its convertible securities.
No
shares held by any Director or named executive officer has been pledged
as
collateral security.
|
(2) |
GCE
Holdings LLC, a Delaware limited liability company, was the assignee
of
all of the our preferred stock (prior to its conversion into common
stock)
and bridge loans entered into in 2005, 2006 and 2007 (prior to their
conversion into common stock and warrants) formerly held by each
of Galen
Partners III, L.P., Galen Partners International III, L.P., Galen
Employee
Fund III, L.P. (collectively, “Galen”), Care Capital Investments II, LP,
Care Capital Offshore Investments II, LP (collectively, “Care Capital”)
and Essex Woodlands Health Ventures Fund V, L.P. (“Essex”). Galen, Care
Capital and Essex own approximately 39.8%, 30.6% and 29.6%, respectively,
of the membership interests in GCE Holdings LLC. The following natural
persons exercise voting, investment and dispositive rights over our
securities held of record by GCE Holdings LLC: (i) Galen Partners
III,
L.P., Galen Partners International III, L.P. and Galen Employee Fund
III,
L.P.: Bruce F. Wesson, L. John Wilkenson, David W. Jahns, and Zubeen
Shroff; (ii) Care Capital Investments II, LP and Care Capital Offshore
Investments II, LP: Jan Leschly, Richard Markham, Argeris Karabelas
and
David Ramsay; and (iii) Essex Woodlands Health Ventures Fund V, L.P.:
Immanuel Thangaraj, James L. Currie and Martin P. Sutter. Pursuant
to a
Voting Agreement among us, GCE Holdings LLC and certain other
shareholders, GCE Holdings LLC has the right to designate three of
the
seven members of the Company’s Board of Directors. The Board designees of
GCE Holdings LLC are Immanuel Thangaraj, Richard Markham and Bruce
Wesson.
Amounts for GCE Holdings, LLC include 1,786,481 shares underlying
warrants, exercisable at $3.40 per share.
|
(3) |
Includes
shares held by an affiliated fund. Includes warrants to purchase
450,000
shares exercisable at $3.40 per share held by Vivo Ventures Fund
VI, L.P.
and an affiliated fund.
Number
of shares give effect to the transfer of warrants to purchase 496,364
and
3,636 shares from Vivo Ventures Fund VI, L.P. and Vivo Ventures VI
Affiliates Fund, L.P., respectively, to Warrant Strategies Fund,
LLC on
November 30, 2007 but are otherwise current as of November 20,
2007.
|
(4) |
Includes
875,000 shares subject to currently exercisable stock options. Excludes
825,000 restricted stock unit awards (“RSUs”) granted to Mr. Reddick. Mr.
Reddick has no rights as a stockholder, including no dividend or
voting
rights, with respect to the shares underlying the RSUs until the
shares
are issued by the Company pursuant to the terms of Company’s 2005
Restricted Stock Unit Plan.
|
(5) |
Includes
700,000 shares subject to currently exercisable stock options. Excludes
660,000 RSUs granted to Dr. Spivey. Dr. Spivey has no rights as a
stockholder, including no dividend or voting rights, with respect
to the
shares underlying the RSUs until the shares are issued by the Company
pursuant to the terms of Company’s 2005 Restricted Stock Unit
Plan.
|
(6) |
Includes
29,000 shares subject to currently exercisable stock options. Excludes
100,000 RSUs granted to Mr. Skelly. Mr. Skelly has no rights as a
stockholder, including no dividend or voting rights, with respect
to the
shares underlying the RSUs until the shares are issued by the Company
pursuant to the terms of the Company’s 2005 Restricted Stock Unit Plan.
|
(7) |
Mr.
Wesson’s holdings do not include securities held by GCE or (i) 183,886
shares; (ii) 470,184 shares underlying warrants; or (iii) 15,000
shares
underlying options, held by Galen.
|
(8) |
Includes
5,000 shares subject to currently exercisable stock options. Excludes
100,000 RSUs granted to Mr. Sumner. Mr. Sumner has no rights as a
stockholder, including no dividend or voting rights, with respect
to the
shares underlying the RSUs until the shares are issued by the Company
pursuant to the terms of the Company’s 2005 Restricted Stock Unit Plan.
|
(9) |
Includes
100,000 shares subject to stock options exercisable with 60 days
of March
1, 2008. Excludes 440,000 RSUs granted to Mr. Clemens. Mr. Clemens
has no
rights as a stockholder, including no dividend or voting rights,
with
respect to the shares underlying the RSUs until the shares are issued
by
the Company pursuant to the terms of Company’s 2005 Restricted Stock Unit
Plan. Includes 4,780 shares held by minor
children.
|
(10) |
Mr.
Markham’s holdings do not include amounts held by GCE or (i) 111,689
shares; or (ii) 15,000 shares underlying warrants, held by Care
Capital.
|
(11) |
Mr.
Thangaraj’s holdings do not include GCE’s holdings or (i) 136,178 shares;
(ii) 34,500 shares underlying warrants; or (iii) 10,000 shares underlying
options, held by Essex.
|
(12) |
Includes
40,000 shares subject to stock options exercisable within sixty days
of
March 1, 2008. Excludes 165,000 RSUs granted to Mr. Seiser. Mr. Seiser
has
no rights as a stockholder, including no dividend or voting rights,
with
respect to the shares underlying the RSUs until the shares are issued
by
the Company pursuant to the terms of Company’s 2005 Restricted Stock Unit
Plan.
|
(13) |
Includes
40,000 shares subject to stock options exercisable within 60 days
of March
1, 2008. Excludes 137,500 RSUs granted to Mr. Emigh. Mr. Emigh has
no
rights as a stockholder, including no dividend or voting rights,
with
respect to the shares underlying the RSUs until the shares are issued
by
the Company pursuant to the terms of Company’s 2005 Restricted Stock Unit
Plan.
|
(14) |
Includes
5,000 shares which Mr. Ross has the right to acquire within 60 days
of
February 1, 2008 through exercise of outstanding stock
options.
|
(15) |
Includes
36,103 shares which Directors and executive officers have the right
to
acquire within 60 days of February 1, 2008 through exercise of outstanding
stock options.
|
2006
|
2007
|
||||||
Audit
Fees
|
$
|
87,600
|
$
|
85,825
|
|||
Audit-Related
Fees
|
-
|
-
|
|||||
Total
Audit and Audit-Related Fees
|
87,600
|
85,825
|
|||||
Tax
Fees
|
25,600
|
30,168
|
|||||
All
Other Fees
|
1,333
|
-
|
|||||
Total
for BDO Seidman, LLP
|
$
|
114,533
|
$
|
115,993
|
Date:
March 5, 2008
|
ACURA
PHARMACEUTICALS, INC.
|
|
By
:
|
ANDREW
D. REDDICK
|
|
Andrew
D. Reddick
President
and Chief Executive Officer
(Principal
Executive Officer)
|
Signature
|
Title(s)
|
Date
|
||
/s/
Andrew D. Reddick
|
President,
Chief Executive Officer and
|
March
5, 2008
|
||
Andrew
D. Reddick
|
Director
|
|||
(Principal
Executive Officer)
|
|
|||
/s/
Peter A. Clemens
|
Senior
Vice President and Chief Financial
|
March
5, 2008
|
||
Peter
A. Clemens
|
Officer
(Principal Financial and Accounting
|
|
||
Officer)
|
||||
/s/
William G. Skelly
|
Director
|
March
5, 2008
|
||
William
G. Skelly
|
|
|||
/s/
Bruce F. Wesson
|
Director
|
March
5, 2008
|
||
Bruce
F. Wesson
|
|
|||
/s/
William A. Sumner
|
Director
|
March
5, 2008
|
||
William
A. Sumner
|
|
|||
/s/Richard
J. Markham
|
Director
|
March
5, 2008
|
||
Richard
J. Markham
|
|
|||
/s/
Immanuel Thangaraj
|
Director
|
March
5, 2008
|
||
Immanuel
Thangaraj
|
|
|||
/s/
George K. Ross
|
Director
|
March
5, 2008
|
||
George
K. Ross
|
|
|
Page
|
|||
Report
of Independent Registered Public Accounting Firm
|
F-2
|
|||
Consolidated
Balance Sheets
|
F-3
|
|||
|
||||
Consolidated
Statements of Operations
|
F-4
|
|||
Consolidated
Statements of Stockholders' Equity (Deficit)
|
F-5
|
|||
Consolidated
Statements of Cash Flows
|
F-6
- F-7
|
|||
Notes
to Consolidated Financial Statements
|
F-8 - F-23
|
/s/
BDO Seidman, LLP
|
2007
|
2006
|
||||||
ASSETS
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
31,368
|
$
|
228
|
|||
Collaboration
revenue receivable
|
2,977
|
-
|
|||||
Prepaid
clinical study costs
|
388
|
-
|
|||||
Prepaid
insurance
|
202
|
179
|
|||||
Prepaid
expenses and other current assets
|
47
|
60
|
|||||
Deferred
income taxes
|
9,600
|
-
|
|||||
Total
current assets
|
44,582
|
467
|
|||||
Property,
plant and equipment, net
|
1,046
|
1,145
|
|||||
Deposits
|
-
|
7
|
|||||
Total
assets
|
$
|
45,628
|
$
|
1,619
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
|||||||
Current
liabilities
|
|||||||
Senior
secured convertible bridge term notes, net
|
$
|
-
|
$
|
7,005
|
|||
Conversion
features on bridge term notes
|
-
|
16,750
|
|||||
Secured
term note
|
-
|
5,000
|
|||||
Current
maturities of capital lease obligations
|
-
|
25
|
|||||
Deferred
program fee revenue – current portion
|
21,942
|
-
|
|||||
Accrued
expenses
|
334
|
328
|
|||||
Total
current liabilities
|
22,276
|
29,108
|
|||||
Non-current
liabilities
|
|||||||
Common
stock warrants
|
-
|
10,784
|
|||||
Capital
lease obligations, less current maturities
|
-
|
7
|
|||||
Deferred
program fee revenue - non current portion
|
4,632
|
-
|
|||||
Total
liabilities
|
26,908
|
39,899
|
|||||
Commitments
and contingencies (Note J)
|
|||||||
Stockholders’
equity (deficit)
|
|||||||
Common
stock - $.01 par value;
650,000,000
shares authorized;
42,706,466
and 33,099,846 shares issued and
outstanding
in 2007 and 2006, respectively
|
427
|
331
|
|||||
Additional
paid-in capital
|
340,153
|
278,932
|
|||||
Accumulated
deficit
|
(321,860
|
)
|
(317,543
|
)
|
|||
18,720
|
(38,280
|
)
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
45,628
|
$
|
1,619
|
2007
|
2006
|
2005
|
||||||||
Revenues
|
||||||||||
Program
fee revenue
|
$
|
3,427
|
$
|
-
|
$
|
-
|
||||
Collaboration
revenue
|
2,977
|
-
|
-
|
|||||||
Total
revenue
|
6,404
|
-
|
-
|
|||||||
Operating
expenses
|
||||||||||
Research
and development expense
|
7,169
|
5,172
|
6,265
|
|||||||
Marketing,
general and administrative expense
|
4,141
|
5,654
|
5,296
|
|||||||
Total
operating expenses
|
11,310
|
10,826
|
11,561
|
|||||||
Loss
from operations
|
(4,906
|
)
|
(10,826
|
)
|
(11,561
|
)
|
||||
Other
income (expense)
|
||||||||||
Interest
income
|
268
|
18
|
36
|
|||||||
Interest
expense
|
(1,207
|
)
|
(1,140
|
)
|
(636
|
)
|
||||
Amortization
of debt discount
|
(2,700
|
)
|
(183
|
)
|
-
|
|||||
(Loss)
gain on fair value change of conversion features
|
(3,483
|
)
|
4,235
|
-
|
||||||
(Loss)
gain on fair value change of common stock warrants
|
(1,905
|
)
|
2,164
|
-
|
||||||
Gain
(loss) on asset disposals
|
22
|
(22
|
)
|
81
|
||||||
Other
(expense) income
|
(3
|
)
|
(213
|
)
|
5
|
|||||
Total
other income (expense)
|
(9,008
|
)
|
4,859
|
(514
|
)
|
|||||
Loss
before income tax benefit
|
(13,914
|
)
|
(5,967
|
)
|
(12,075
|
)
|
||||
Income
tax benefit
|
(9,600
|
)
|
-
|
-
|
||||||
Net
loss
|
$
|
(4,314
|
)
|
$
|
(5,967
|
)
|
$
|
(12,075
|
)
|
|
Basic
and diluted loss per share
applicable to common stockholders (Note A) |
$
|
(0.11
|
)
|
$
|
(0.75
|
)
|
$
|
(1.81
|
)
|
|
Weighted
average shares used in computing basic and diluted loss per share
allocable to common stockholders
|
39,157
|
34,496
|
6,680
|
Common Stock
$0.01 Par Value
|
|
Preferred Stock
$0.01 Par Value
|
|
Additional
Paid-in
|
|
Unearned
|
|
Accumulated
|
|
|
|
||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Compensation
|
|
Deficit
|
|
Total
|
|||||||||
Balance
at January 1, 2005
|
2,247
|
$
|
23
|
217,973
|
$
|
2,180
|
$
|
277,330
|
$
|
(1,078
|
)
|
$
|
(279,541
|
)
|
$
|
(1,086
|
)
|
||||||||
Net
loss for the year ended December 31, 2005
|
(12,075
|
)
|
(12,075
|
)
|
|||||||||||||||||||||
Intrinsic
value of issued options and restricted stock units
|
11,105
|
(11,105
|
)
|
-
|
|||||||||||||||||||||
Amortization
of unearned compensation
|
6,459
|
6,459
|
|||||||||||||||||||||||
Issuance
of Common Shares for exercise of options
|
3
|
-
|
5
|
5
|
|||||||||||||||||||||
Issuance
of Common Shares for interest
|
96
|
1
|
534
|
535
|
|||||||||||||||||||||
Conversion
of Preferred Shares:
|
|||||||||||||||||||||||||
Series
A Convertible Preferred
|
10,982
|
110
|
(21,964
|
)
|
(220
|
)
|
110
|
-
|
|||||||||||||||||
Series
B Junior Convertible
|
2,025
|
20
|
(20,246
|
)
|
(203
|
)
|
183
|
-
|
|||||||||||||||||
Series
C-1 Junior Convertible
|
5,642
|
56
|
(56,423
|
)
|
(564
|
)
|
508
|
-
|
|||||||||||||||||
Series
C-2 Junior Convertible
|
3,743
|
37
|
(37,433
|
)
|
(374
|
)
|
337
|
-
|
|||||||||||||||||
Series
C-3 Junior Convertible
|
8,191
|
82
|
(81,907
|
)
|
(819
|
)
|
737
|
-
|
|||||||||||||||||
Balance
at December 31, 2005
|
32,929
|
$
|
329
|
-
|
$
|
-
|
$
|
290,849
|
$
|
(5,724
|
)
|
$
|
(291,616
|
)
|
$
|
(6,162
|
)
|
||||||||
Net
loss for the year ended December 31, 2006
|
(5,967
|
)
|
(5,967
|
)
|
|||||||||||||||||||||
Deemed
dividend related to debt modification
|
(19,960
|
)
|
(19,960
|
)
|
|||||||||||||||||||||
Adoption
of FAS 123R
|
(5,724
|
)
|
5,724
|
-
|
|||||||||||||||||||||
Issuance
of restricted stock units
|
680
|
680
|
|||||||||||||||||||||||
Other
stock based compensation
|
5,046
|
5,046
|
|||||||||||||||||||||||
Reclassification
of value of common stock warrants to liabilities
|
(12,948
|
)
|
(12,948
|
)
|
|||||||||||||||||||||
Issuance
of Common Shares for exercise of options
|
40
|
1
|
97
|
98
|
|||||||||||||||||||||
Issuance
of Common Shares for interest
|
128
|
1
|
932
|
933
|
|||||||||||||||||||||
Issuance
of Common Shares for cashless exercise of warrant
|
2
|
-
|
|||||||||||||||||||||||
Balance
at December 31, 2006
|
33,099
|
$
|
331
|
-
|
$
|
-
|
$
|
278,932
|
$
|
-
|
$
|
(317,543
|
)
|
$
|
(38,280
|
)
|
|||||||||
Net
loss for the year ended December 31, 2007
|
(4,314
|
)
|
(4,314
|
)
|
|||||||||||||||||||||
Deemed
dividend related to debt modification
|
(3
|
)
|
(3
|
)
|
|||||||||||||||||||||
Reclassification
of conversion feature value
|
21,086
|
21,086
|
|||||||||||||||||||||||
Reclassification
of common stock warrant value
|
12,453
|
12,453
|
|||||||||||||||||||||||
Conversion
feature value of issued debt
|
1,789
|
1,789
|
|||||||||||||||||||||||
Other
stock based compensation
|
915
|
915
|
|||||||||||||||||||||||
Net
proceeds from unit offering
|
5,556
|
56
|
14,090
|
14,146
|
|||||||||||||||||||||
Conversion
of bridge loan notes, net
|
3,905
|
39
|
9,961
|
10,000
|
|||||||||||||||||||||
Issuance
of Common Shares for exercise of options
|
31
|
-
|
116
|
116
|
|||||||||||||||||||||
Issuance
of Common Shares for interest
|
84
|
1
|
811
|
812
|
|||||||||||||||||||||
Issuance
of Common Shares for cashless exercise of warrants
|
32
|
-
|
-
|
-
|
|||||||||||||||||||||
Reverse
stock split
|
(1
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
Balance
at December 31, 2007
|
42,706
|
$
|
427
|
-
|
$
|
-
|
$
|
340,153
|
$
|
-
|
$
|
(321,860
|
)
|
$
|
18,720
|
|
2007
|
2006
|
2005
|
|||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(4,314
|
)
|
$
|
(5,967
|
)
|
$
|
(12,075
|
)
|
|
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
||||||||||
Depreciation
and amortization
|
130
|
118
|
137
|
|||||||
Amortization
of debt discount
|
2,700
|
183
|
-
|
|||||||
Loss
(gain) on the fair value change of conversion features
|
3,483
|
(4,235
|
)
|
-
|
||||||
Loss
(gain) on the fair value change of common stock warrants
|
1,905
|
(2,164
|
)
|
-
|
||||||
Non-cash
stock compensation expense
|
915
|
5,724
|
6,459
|
|||||||
(Gain)
loss on asset disposals
|
(22
|
)
|
22
|
(81
|
)
|
|||||
Common
stock issued for interest
|
812
|
933
|
535
|
|||||||
Deferred
income taxes
|
(9,600
|
)
|
-
|
-
|
||||||
Impairment
charge against fixed assets
|
-
|
71
|
-
|
|||||||
Changes
in assets and liabilities
|
||||||||||
Collaboration
revenue receivable
|
(2,977
|
)
|
-
|
-
|
||||||
Prepaid
expenses and other current assets
|
(398
|
)
|
(55
|
)
|
121
|
|||||
Other
assets and deposits
|
7
|
-
|
(5
|
)
|
||||||
Accrued
expenses
|
5
|
(13
|
)
|
(618
|
)
|
|||||
Deferred
program fee revenue
|
26,574
|
-
|
-
|
|||||||
Net
cash provided by (used in) operating activities
|
19,220
|
(5,383
|
)
|
(5,527
|
)
|
|||||
Cash
flows from investing activities:
|
||||||||||
Capital
expenditures
|
(31
|
)
|
(85
|
)
|
(35
|
)
|
||||
Proceeds
from asset disposals
|
22
|
70
|
193
|
|||||||
Net
cash (used in) provided by investing activities
|
(9
|
)
|
(15
|
)
|
158
|
|||||
Cash
flows from financing activities:
|
||||||||||
Proceeds
from issuance of senior secured bridge term notes
|
2,696
|
5,298
|
2,550
|
|||||||
Repayments
on secured term note
|
(5,000
|
)
|
-
|
-
|
||||||
Net
proceeds from the unit offering
|
14,146
|
-
|
-
|
|||||||
Proceeds
from exercise of stock options
|
119
|
98
|
5
|
|||||||
Payments
on capital lease obligations
|
(32
|
)
|
(31
|
)
|
(29
|
)
|
||||
Net
cash provided by financing activities
|
11,929
|
5,365
|
2,526
|
|||||||
Net
increase (decrease) in cash and cash equivalents
|
31,140
|
(33
|
)
|
(2,843
|
)
|
|||||
Cash
and cash equivalents at beginning of period
|
228
|
260
|
3,103
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
31,368
|
$
|
228
|
$
|
260
|
||||
Cash
paid during the period:
|
||||||||||
Interest
|
$
|
395
|
$
|
207
|
$
|
101
|
||||
Income
taxes
|
$
|
-
|
$
|
-
|
$
|
-
|
1.
|
The
Company issued 47,552 shares of common stock valued at $460,000
as payment
of Senior Secured Convertible Bridge Term Notes Payable accrued
interest.
|
2.
|
The
Company issued 36,150 shares of common stock valued at $352,000
as payment
of Secured Term Note Payable accrued
interest.
|
3.
|
Warrants
to purchase an aggregate 58,000 shares of common stock were exercised
at
exercise prices between $1.20 and $6.60 per share in a series
of cashless
exercise transactions resulting in the issuance of aggregate
31,361 shares
of common stock.
|
4.
|
The
issuance of $896,000 Senior Secured Convertible Bridge term Notes
during
the period January 1, 2007 through March 29, 2007 included conversion
features measured at $849,000, which resulted in the recording
of an equal
amount of debt discount and conversion feature liabilities.
|
5.
|
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.
|
6.
|
The
issuance of $1,800,000 of Senior Secured Bridge Term Notes included
conversion features measured at $1,552,000, which resulted in
a recording
of an equal amount of debt discount to
equity.
|
7.
|
The
change in the common stock warrants’ fair value through the earlier of
their exercise date or 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 1,592,100 outstanding common stock warrants of $12,307,000
was reclassified from liabilities to equity, as was $146,000
of such value
related to warrants exercised during the
period.
|
8.
|
Anti-dilution
provisions in certain warrant grants were triggered resulting
in a loss of
$236,000 with an equal amount recorded against
equity.
|
9.
|
Senior
Secured Convertible Bridge Term Notes Payable of $10,544,000,
less
unamortized debt discount of $544,000 was converted into 3,905,184
shares
of common stock.
|
1.
|
The
Company issued 85,464 shares of Common Stock as payment of $624,000
of
Secured Term Note Payable accrued
interest.
|
2.
|
The
Company issued 42,650 shares of Common Stock as payment of $309,000
of
Bridge Loan Notes Payable accrued
interest.
|
3.
|
Warrants
to purchase 16,593 shares of Common Stock were exercised in March
2006 at
an exercise price of $4.80 per share in a cashless exercise transaction
resulting in the issuance of 19,065 shares of Common
Stock.
|
4.
|
Warrants
to purchase 3,069 shares of Common Stock were exercised in May
2006 at an
exercise price of $4.70 per share in a cashless exercise transaction
resulting in the issuance of 473 shares of Common
Stock.
|
5.
|
A
warrant to purchase 15,000 shares of Common Stock was modified
due to its
anti-dilution clause resulting in a $142,000 stock compensation
expense.
|
6.
|
The
modification of conversion features embedded within Bridge Loan
Notes
Payable was valued at $19,951,000 and the issuance of $1,104,000
of Bridge
Loan Notes Payable contained conversion features valued at $1,035,000.
The
change in the conversion feature’s fair value through December 31, 2006
resulted in a gain of $4,235,000.
|
7.
|
Due
to certain debt conversion feature modifications, the then current
fair
value of all 16,331,000 outstanding common stock warrants of
$12,948,000
was reclassified from equity to liabilities. The change in the
common
stock warrants fair value through December 31, 2006 resulted
in a gain of
$2,164,000.
|
8. |
Bridge
Loan Notes Payable of $1,104,000 contained $1,025,000 of debt
discount.
|
1. |
The
Company issued 96,300 shares of common stock as payment of $535,000
of
Secured Term Note Payable accrued
interest.
|
2. |
21,797,300
shares of Convertible Preferred Stock were converted into 30,582,800
shares of Common Stock.
|
Year
ended December 31, 2005
|
||||
(in
thousands except per share data)
|
||||
Net
loss, as reported
|
$
|
(12,075
|
)
|
|
Add:
total stock-based employee compensation expense included in reported
net
loss
|
6,459
|
|||
Deduct:
total stock-based employee compensation expense determined under
fair
value-based method for all awards
|
(7,242
|
)
|
||
Net
loss, pro forma
|
$
|
(12,858
|
)
|
|
Loss
per share:
|
||||
Basic
and Diluted EPS - as reported
|
$
|
(1.81
|
)
|
|
Basic
and Diluted EPS - as pro forma
|
$
|
(1.90
|
)
|
Convertible
Preferred Stock |
A
uthorized
and Available for
Issuance
at
12/31/07 and 12/31/06
|
|||
Series
A
|
23,036
|
|||
Series
B Junior
|
4,754
|
|
||
Series
C-1 Junior
|
13,577
|
|||
Series
C-2 Junior
|
12,567
|
|||
Series
C-3 Junior
|
18,093
|
|||
Total
|
72,027
|
|
December
31,
|
||||||
|
2007
|
2006
|
|||||
Building
and building improvements
|
$
|
1,391
|
$
|
1,391
|
|||
Land
and land improvements
|
161
|
161
|
|||||
Machinery
and equipment
|
598
|
2,183
|
|||||
Scientific
equipment
|
445
|
481
|
|||||
Computer
hardware and software
|
201
|
203
|
|||||
Office
equipment
|
42
|
42
|
|||||
Other
personal property
|
48
|
50
|
|||||
2,886
|
4,511
|
||||||
Less
accumulated depreciation and amortization
(including
$36 in 2006 on capital leased assets)
|
(1,758
|
)
|
(3,200
|
)
|
|||
1,128
|
1,311
|
||||||
Less
impairment reserve
|
(82
|
)
|
(166
|
)
|
|||
Total
property, plant and equipment, net
|
$
|
1,046
|
$
|
1,145
|
|
December
31,
|
||||||
|
2007
|
2006
|
|||||
Bonus,
payroll, payroll taxes and benefits
|
$
|
63
|
$
|
62
|
|||
Legal
fees
|
35
|
19
|
|||||
Audit
examination and tax preparation fees
|
120
|
70
|
|||||
Franchise
taxes
|
15
|
15
|
|||||
Property
taxes
|
34
|
52
|
|||||
Clinical,
regulatory, trademarks, and patent consulting fees
|
50
|
60
|
|||||
Other
fees and services
|
17
|
50
|
|||||
$
|
334
|
$
|
328
|
Senior
secured convertible bridge term notes:
|
||||
Face
value
|
$
|
7,848
|
||
Debt
discount
|
(843
|
)
|
||
|
7,005
|
|||
Conversion
feature value
|
16,750
|
|||
$
|
23,755
|
|||
Secured
term note payable
|
$
|
5,000
|
||
Capital
lease obligations
|
$
|
32
|
|
Mar
30,
2007
|
Dec
31,
2006
|
|||||
Company
stock price
|
$
|
8.50
|
$
|
7.40
|
|||
Exercise
price
|
(see
#1 below)
|
|
(see
#1 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
|
(b) |
Secured
Term Note
|
|
Years
Ended December 31,
|
||||||||||||||||||
|
2007
|
2006
|
2005
|
||||||||||||||||
|
Amount
|
%
|
Amount
|
%
|
Amount
|
%
|
|||||||||||||
Federal
statutory rate
|
$
|
(4,731
|
)
|
(34.0
|
)
|
$
|
(2,029
|
)
|
(34.0
|
)
|
$
|
(4,105
|
)
|
(34.0
|
)
|
||||
State
taxes, net of Federal effect
|
(413
|
)
|
(3.0
|
)
|
(537
|
)
|
(9.0
|
)
|
(609
|
)
|
(5.0
|
)
|
|||||||
Research
credits
|
(220
|
)
|
(1.6
|
)
|
(126
|
)
|
(2.1
|
)
|
(125
|
)
|
(1.0
|
)
|
|||||||
Other
|
(20
|
)
|
(0.1
|
)
|
26
|
0.5
|
39
|
0.3
|
|||||||||||
|
|
|
|
|
|
|
|||||||||||||
Impact
of non-taxable items
|
|
|
|
|
|
|
|||||||||||||
Reduction
in NOL carryforwards
|
1,338
|
9.6
|
-
|
-
|
-
|
-
|
|||||||||||||
Conversion
feature fair value change
|
1,184
|
8.5
|
(1,440
|
)
|
(24.1
|
)
|
-
|
-
|
|||||||||||
Debt
discount amortization
|
918
|
6.6
|
62
|
1.0
|
-
|
-
|
|||||||||||||
Warrant
fair value change
|
648
|
4.7
|
(736
|
)
|
(12.4
|
)
|
-
|
-
|
|||||||||||
Non-deductible
financing costs
|
311
|
2.2
|
320
|
5.4
|
-
|
-
|
|||||||||||||
Wage
limitation
|
51
|
0.4
|
-
|
-
|
-
|
-
|
|||||||||||||
Other
|
(95
|
)
|
(0.7
|
)
|
-
|
-
|
-
|
-
|
|||||||||||
|
(1,029
|
)
|
(7.4
|
)
|
(4,460
|
)
|
(74.7
|
)
|
(4,800
|
)
|
(39.7
|
)
|
|||||||
Change
in valuation allowance
|
10,629
|
76.4
|
4,460
|
74.7
|
4,800
|
39.7
|
|||||||||||||
Recorded
tax benefit
|
$
|
9,600
|
69.0
|
$
|
-
|
-
|
$
|
-
|
-
|
December
31,
|
|||||||
2007
|
2006
|
||||||
Deferred
income tax assets:
|
|||||||
NOL
carryforwards - federal
|
$
|
45,993
|
$
|
48,026
|
|||
NOL
carryforwards
–
state/city
|
8,304
|
7,837
|
|||||
Research
credits
|
625
|
382
|
|||||
Stock
based compensation
|
5,852
|
5,497
|
|||||
Warrant
compensation
|
21
|
56
|
|||||
Other
|
55
|
90
|
|||||
Deferred
income tax assets
|
60,850
|
61,888
|
|||||
Deferred
income tax liabilities:
|
|||||||
Depreciation
|
(16
|
)
|
(25
|
)
|
|||
Gross
deferred income tax assets
|
60,834
|
61,863
|
|||||
Valuation
allowance
|
(51,234
|
)
|
(61,863
|
)
|
|||
Net
deferred income tax assets
|
$
|
9,600
|
$
|
-
|
1. |
401(k)
and Profit-sharing Plan
|
2. |
Stock
Option Plans
|
Years
Ended
December 31,
|
|||||||||||||||||||
2007
|
2006
|
2005
|
|||||||||||||||||
Number
of Options (000’s) |
Weighted
Average Exercise Price |
Number
of Options (000’s) |
Weighted
Average
Exercise
Price
|
Number
of
Options
(000’s) |
Weighted
Average
Exercise
Price
|
||||||||||||||
Outstanding,
beginning
|
1,899
|
$
|
2.60
|
1,975
|
$
|
2.70
|
1,750
|
$
|
4.40
|
||||||||||
Granted
|
-
|
-
|
-
|
-
|
400
|
1.30
|
|||||||||||||
Exercised
|
(31
|
)
|
3.80
|
(40
|
)
|
2.50
|
(4
|
)
|
1.30
|
||||||||||
Forfeited
or expired
|
(10
|
)
|
3.60
|
(36
|
)
|
10.40
|
(171
|
)
|
16.50
|
||||||||||
Outstanding,
ending
|
1,858
|
$
|
2.60
|
1,899
|
$
|
2.60
|
1,975
|
$
|
2.70
|
||||||||||
|
|||||||||||||||||||
Options
exercisable,
end
of year
|
1,827
|
$
|
2.56
|
1,837
|
$
|
2.60
|
1,569
|
$
|
3.10
|
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||
Range
of Exercise
Prices |
Number
of Options
(000’s) |
Weighted
Average Remaining Contractual
Life |
Weighted
Average
Exercise
Price |
Number
of
Vested Options (000’s) |
Weighted
Average
Exercise
Price |
|||||||||||
$
1.30 to $10.00
|
1,729
|
6.62
|
$
|
1.34
|
1,698
|
$ | 1.34 | |||||||||
$10.01
to $20.00
|
70
|
2.06
|
14.29
|
70
|
14.29 | |||||||||||
$20.01
to $25.00
|
59
|
0.84
|
23.81
|
59
|
23.81 | |||||||||||
|
|
|
|
|
||||||||||||
Total
|
1,858
|
6.27
|
$
|
2.54
|
1,827
|
$ | 2.56 |
|
Number
of
Options Not Exercisable |
Weighted
Average Fair Value |
|||||
Outstanding
at December 31, 2006
|
62
|
$
|
3.10
|
||||
Granted
|
-
|
-
|
|||||
Vested
|
(31
|
)
|
3.10
|
||||
Forfeited
or expired
|
-
|
-
|
|||||
|
|
|
|||||
Outstanding
at December 31, 2007
|
31
|
$
|
3.10
|
2005
|
||||
Expected
dividend
|
0.0
|
%
|
||
Risk-free
interest rate
|
4.5
|
%
|
||
Expected
volatility
|
120
|
%
|
||
Weighted
average volatility
|
120
|
%
|
||
Forfeitures
|
0.0
|
%
|
||
Expected
term
|
4
years
|
|||
Weighted
average grant date fair value
|
$
|
4.50
|
Three
Month Period Ended
|
|||||||||||||
Calendar
Year 2007
|
Mar.
31
|
June
30
|
Sept.
30
|
Dec.
31
|
|||||||||
Total
revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
6,404
|
|||||
Loss
from operations
|
(1,974
|
)
|
(1,340
|
)
|
(1,420
|
)
|
(
172
|
)
|
|||||
Net
income (loss)
|
(9,159
|
)
|
(2,199
|
)
|
(2,476
|
)
|
9,521
|
||||||
Income
(loss) per common share
(after
deemed dividend) (Note A)
|
|||||||||||||
Basic
|
$
|
(0.26
|
)
|
$
|
(0.06
|
)
|
$
|
(0.06
|
)
|
$
|
0.21
|
||
Diluted
|
$
|
(0.26
|
)
|
$
|
(0.06
|
)
|
$
|
(0.06
|
)
|
$
|
0.20
|
||
Calendar
Year 2006
|
Mar.
31
|
June
30
|
Sept.
30
|
Dec.
31
|
|||||||||
Total
revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
|||||
Loss
from operations
|
(3,927
|
)
|
(2,341
|
)
|
(2,661
|
)
|
(
1,897
|
)
|
|||||
Net
income (loss)
|
(4,155
|
)
|
(2,615
|
)
|
(3,097
|
)
|
3,900
|
||||||
Income
(loss) per common share
(after
deemed dividend) (Note A)
|
|||||||||||||
Basic
|
$
|
(0.12
|
)
|
$
|
(0.08
|
)
|
$
|
(0.11
|
)
|
$
|
(0.44
|
)
|
|
Diluted
|
$
|
(0.12
|
)
|
$
|
(0.08
|
)
|
$
|
(0.11
|
)
|
$
|
(0.44
|
)
|
Exhibit
Number
|
|
Exhibit
Description
|
3.1
|
Restated
Certificate of Incorporation of the Registrant (incorporated by
reference
to Appendix C to the Registrant's Proxy Statement filed on July
6,
2004).
|
|
3.2
|
Certificate
of Amendment Reverse Splitting Common Stock and restating but not
changing
text of part of Article III of Restated Certificate of Incorporation
(incorporated by Reference to Exhibit 3.1 to the Form 8-K filed
December
4, 2007).
|
|
3.3
|
|
Restated
Bylaws of the Registrant (incorporated by reference to Exhibit
3.1 to the
Form 8-K filed on October 12, 2007).
|
10.1
|
License,
Development and Commercialization Agreement by and between the
Registrant
and King Pharmaceuticals Research and Development, Inc. (incorporated
by
reference to Exhibit 10.1 of the Form 8-K filed on November 2,
2007).
(confidential treatment has been requested for portions of this
Exhibit).
|
|
|
|
|
10.2
|
Securities
Purchase Agreement dated as of August 20, 2007 (“PIPE SPA”) among the
Registrant, Vivo Ventures Fund VI, L.P., Vivo Ventures VI Affiliates
Fund,
L.P. (collectively “Vivo”), GCE Holdings LLC, and certain other
signatories thereto (incorporated by reference to Exhibit 10.1
to the Form
8-K filed on August 21, 2007).
|
|
10.3
|
Form
of Warrant dated as of August 20, 2007 issued pursuant to the PIPE SPA
(incorporated by reference to Exhibit 4.1 to the Form 8-K filed
on August
21, 2007).
|
|
10.4
|
|
Common
Stock Purchase Warrant issued to Watson Pharmaceuticals, Inc. (“WPI”)
dated December 20, 2002 (incorporated by reference to Exhibit 10.15
to the
Form 8-K filed on December 27, 2002).
|
|
|
|
10.5
|
Form
of Warrants dated August 15, 2001 issued to Galen Partners III,
L.P.,
Galen Partners International, III, L.P. and Galen Employee Fund
III, L.P.
(currently exercisable at $9.90 per share) (incorporated by reference
to
Exhibit 10.3 to the Form S-3 filed on October 1, 2007 (the “October 2007
S-3”)).
|
|
10.6
|
Form
of Warrants dated January 9, 2002, February 1, 2002, March 1, 2002,
and
April 5, 2002 issued to Galen Partners III, L.P., Galen Partners
International, III, L.P. and Galen Employee Fund III, L.P. (currently
exercisable at an exercise price of $3.40 per share) (incorporated
by
reference to Exhibit 10.4 to the October 2007 S-3).
|
|
10.7
|
Form
of Warrants dated May 8, 2002, June 3, 2002, July 1, 2002, July
23, 2002,
August 5, 2002, September 3, 2002, October 1, 2002, November 4,
2002,
November 12, 2002, November 21, 2002 and December 5, 2002 issued
to Galen
Partners III, L.P., Galen Partners International, III, L.P. and
Galen
Employee Fund III, L.P. (currently exercisable at an exercise price
of
$3.40 per share) (incorporated by reference to Exhibit 10.5 to
the October
2007 S-3).
|
|
10.8
|
Form
of Warrants dated May 5, 2003 issued to Galen Partners III, L.P.,
Galen
Partners International, III, L.P., Galen Employee Fund III, L.P.,
Essex
Woodlands Health Ventures Fund V, L.P. and Care Capital Investments
II, LP
and others (currently exercisable at an exercise price of $1.285
per
share) (incorporated by reference to Exhibit 10.6 to the October
2007
S-3).
|
Exhibit
Number
|
|
Exhibit
Description
|
10.9
|
|
Amended
and Restated Voting Agreement dated as of February 6, 2004 among
the
Registrant, Care Capital Investments II, LP, Essex Woodlands Health
Ventures Fund V, L.P., Galen Partners III, L.P., and others (incorporated
by reference to Exhibit 10.5 of the Form 8-K filed on February
10, 2004
(the “February 2004 Form 8-K”)).
|
10.10
|
Joinder
and Amendment to Amended and Restated Voting Agreement dated November
9,
2005 between the Registrant, GCE Holdings, Essex Woodlands Health
Ventures
Fund V, L.P., Care Capital Investments II, LP, Galen Partners III,
L.P.
and others (incorporated by reference to Exhibit 10.1 to the Form
8-K
dated November 9, 2005).
|
|
10.11
|
Second
Amendment to Amended and Restated Voting Agreement dated as of
January 24,
2008 between the Registrant and GCE Holdings, LLC (incorporated
by
reference to Exhibit 10.1 to the Form 8-K filed January 28,
2008).
|
|
10.12
|
Amended
and Restated Registration Rights Agreement dated February 6, 2004
among
the Registrant, WPI, Care Capital Investments II, LP, Essex Woodlands
Health Ventures Fund V, L.P., Galen Partners III, L.P. and others
(incorporated by reference to Exhibit 10.6 of the February 2004
Form
8-K).
|
|
10.13
|
|
Registrant’s
1995 Stock Option and Restricted Stock Purchase Plan (incorporated
by
reference to Exhibit 4.1 to the Registrant's Registration Statement
on
Form S-8, File No. 33-98396).
|
|
|
|
10.14
|
|
Registrant’s
1998 Stock Option Plan, as amended (incorporated by reference to
Appendix
C to the Registrant’s Proxy Statement filed on November 16,
2006).
|
|
|
|
10.15
|
|
Registrant’s
2005 Restricted Stock Unit Award Plan, as amended (incorporated
by
reference to Appendix D to the Registrant’s Proxy Statement filed on
November 16, 2006).
|
10.16
|
|
Executive
Employment Agreement dated as of August 26, 2003 between the Registrant
and Andrew D. Reddick (“Reddick”) (incorporated by reference to Exhibit
10.2 to the Form 10-Q for the quarter ended June 30, 2004 (the
“June 2004
10-Q”)).
|
|
|
|
10.17
|
|
Amendment
to Executive Employment Agreement between the Registrant and Reddick,
dated May 27, 2004 (incorporated by reference to Exhibit 10.4 to
the June
2004 10-Q).
|
|
|
|
10.18
|
|
Second
Amendment to Executive Employment Agreement between the Registrant
and
Reddick, dated May 24, 2005 incorporated by reference to Exhibit
10.116 to
the Form 10-K for the year ending December 31, 2005 filed on February
21,
2006).
|
|
|
|
10.19
|
|
Third
Amendment to Executive Employment Agreement between the Registrant
and
Reddick, dated December 22, 2005 (incorporated by reference to
Exhibit
10.1 to the Form 8-K filed December 23, 2005 (the “December 2005 Form
8-K”)).
|
|
|
|
*10.20
|
Fourth
Amendment to Executive Employment Agreement between the Registrant
and
Reddick dated December 16, 2007.
|
|
10.21
|
|
Executive
Employment Agreement dated as of April 5, 2004 between the Registrant
and
Ron J. Spivey (incorporated by reference to Exhibit 10.3 to the
June 2004
10-Q).
|
|
|
|
10.22
|
|
Amendment
to Executive Employment Agreement dated December 22, 2005 between
Registrant and Ron J. Spivey (incorporated by reference to Exhibit
10.2 to
the December 2005 Form 8-K).
|
*10.23
|
Second
Amendment to Executive Employment Agreement dated December 19,
2007
between the Registrant and Ron J.
Spivey.
|
Exhibit
Number
|
|
Exhibit
Description
|
10.24
|
|
Employment
Agreement dated as of March 10, 1998 between the Registrant and
Peter
Clemens (“Clemens”) (incorporated by reference to Exhibit 10.44 to the
1997 Form 10-K, File No. 001-10113).
|
10.25
|
|
First
Amendment to Employment Agreement made as of June 28, 2000 between
the
Registrant and Clemens (incorporated by reference to Exhibit 10.44A
to the
Registrant’s 2005 Form 10-K).
|
|
|
|
10.26
|
|
Second
Amendment to Executive Employment Agreement between Registrant
and
Clemens, dated as of January 5, 2005 (incorporated by reference
to Exhibit
10.1 to the Registrant's Form 8-K dated January 28,
2005).
|
|
|
|
10.27
|
|
Third
Amendment to Executive Employment Agreement dated December 22,
2005
between Registrant and Clemens (incorporated by reference to Exhibit
10.3
to the December 2005 Form 8-K).
|
*10.28
|
Fourth
Amendment to Executive Employment Agreement dated December 16,
2007
between Registrant and Clemens.
|
|
|
||
10.29
|
Loan
Agreement among the Registrant Essex Woodlands Health Ventures
Fund V,
L.P., Care Capital Investments II, LP, Galen Partners III, L.P.
and others
dated January 31, 2006 (the “Loan Agreement,” and together with certain
other bridge loan agreements, the “Loan Agreements”) (incorporated by
reference to the Form 8-K filed on January 31, 2006).
|
|
|
||
10.30
|
|
Form
of Secured Promissory Note of the Registrant relating to January
31, 2006
Loan Agreement.
|
|
||
10.31
|
|
Subordination
Agreement among Essex Woodlands Health Ventures Fund V, L.P., Care
Capital
Investments II, LP, Galen Partners III, L.P., and others dated
January 31,
2006 (incorporated by reference to the Form 8-K filed on January
31,
2006).
|
|
||
10.32
|
|
Guarantor
Security Agreement among Acura Pharmaceutical Technologies, Inc.
(“APT”)
and Galen Partners III, L.P., as Agent, dated January 31, 2006
(incorporated by reference to the Form 8-K filed on January 31,
2006).
|
|
||
10.33
|
|
Omnibus
Amendment effective as of May 24, 2006 among the Registrant and
APT and
certain lenders amending the Loan Agreements (incorporated by reference
to
the Form 8-K filed on May 24, 2006).
|
|
||
10.34
|
|
Omnibus
Amendment effective as of August 16, 2006 among the Registrant,
APT and
certain lenders, amending among other things, the Loan Agreements
(incorporated by reference to the Form 8-K filed on August 16,
2006).
|
10.35
|
|
Omnibus
Amendment effective as of September 22, 2006 among the Registrant,
APT and
certain lenders, amending among other things, the Loan Agreements
(incorporated by reference to the Form 8-K filed on September 25,
2006).
|
|
|
|
10.36
|
|
Omnibus
Amendment effective as of October 20, 2006 among the Registrant,
APT and
certain lenders, amending among other things, the Loan Agreements
(incorporated by reference to the Form 8-K filed on October 20,
2006).
|
|
|
|
10.37
|
|
Omnibus
Amendment effective as of November 30, 2006 among the Registrant
and APT
and certain lenders, amending among other things, the Loan Agreements
(incorporated by reference to the Form 8-K filed on December 4,
2006).
|
Exhibit
Number
|
|
Exhibit
Description
|
10.38
|
Omnibus
Amendment and Consent dated March 30, 2007 among the Registrant,
Galen
Partners III, L.P., Care Capital Investments II, LP, Essex Woodlands
Health Ventures Fund V, L.P. and the other signatories thereto
(incorporated by referenced to Exhibit 10.1 of the Form 8-K filed
April 2,
2007).
|
|
10.39
|
Omnibus
Amendment and Consent effective as of July 10, 2007 among the Registrant,
Galen Partners III, L.P., Care Capital Investments II, LP, Essex
Woodlands
Health Ventures Fund V, L.P. and the other signatories thereto
(incorporated by reference to Exhibit 10.1 of the Form 8-K filed
on July
10, 2007).
|
|
10.40
|
Fourth
Amendment, Waiver and Consent to Loan Agreement dated as of June
28, 2007
between the Registrant and Galen Partners III, LP, as agent (incorporated
by reference to Exhibit 10.1 of the Form 8-K filed on July 5, 2007
(the
“July 5, 2007 8-K”)).
|
|
10.41
|
Consent
and Amendment to Noteholders Agreement among Essex Woodlands Health
Ventures Fund V, L.P., Galen Partners III, L.P. and Care Capital
Investments II, LP, and certain other signatories thereto (incorporated
by
reference to Exhibit 10.2 of the July 5, 2007 8-K).
|
|
10.42
|
Amended
Secured Promissory Note dated as of December 20, 2002 in the principal
amount of $5,000,000 issued by the Registrant, as the maker, in
favor of
Galen Partners III, L.P., as agent (incorporated by reference to
Exhibit
10.3 of the July 5, 2007 8-K).
|
|
10.43
|
Fifth
Amendment, Waiver and Consent to Loan Agreement dated as of August
20,
2007 between the Registrant and Galen Partners III, L.P., as agent
(incorporated by reference to Exhibit 10.2 to the Form 8-K filed
on August
21, 2007).
|
|
10.44
|
Amended
Secured Promissory Note dated as of December 20, 2002 in the principal
amount of $5,000,000 issued by the Registrant, as the maker, in
favor of
Galen Partners III, L.P., as agent (incorporated by reference to
Exhibit
10.3 of the Form 8-K filed on August 21, 2007).
|
|
10.45
|
Sixth
Amendment, Waiver and Consent to Loan Agreement dated as of September
27,
2007 between the Registrant and Galen Partners III, L.P., as agent
(incorporated by reference to Exhibit 10.1 to the Form 8-K filed
on
September 24, 2007).
|
|
10.46
|
Amended
Secured Promissory Note originally issued as of December 20, 2002
in the
principal amount of $5,000,000 issued by the Registrant, as the
maker, in
favor of Galen Partners III, L.P., as Agent (incorporated by reference
to
Exhibit 10.2 of the Form 8-K filed on September 24, 2007).
|
|
14.1
|
|
Code
of Ethics (incorporated by reference to Exhibit 14.1 of the Form
8-K filed
on December 10, 2007).
|
21
|
|
Subsidiaries
of the Registrant (incorporated by reference to the Form 10-K for
the
fiscal year ended December 31, 2006 filed on March 15,
2007).
|
|
|
|
*23.1
|
|
Consent
of Independent Registered Public Accounting Firm.
|
|
|
|
*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.
|
Exhibit
Number
|
|
Exhibit
Description
|
*32
|
|
Certification
of 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.
|
A.
|
The
Corporation and the Employee executed an employment agreement dated
as of
August 26, 2003, which was amended three times (as amended, the
“
Employment
Agreement
”).
|
B.
|
The
Corporation and the Employee now desire to further amend the Employment
Agreement as provided herein.
|
(x)
|
the
Employee’s accrued and unpaid Base Salary through and including the date
of terminations;
|
(y)
|
the
Employee’s then accrued and unused vacation through and including the date
of termination; and
|
(z)
|
the
Employee’s then accrued and unpaid Bonus for such year, calculated by
pro-rating the annual Bonus, which would have been payable to the
Employee
but for his termination and assuming full achievement of the Bonus
Criteria for such year, based on the number of days that the Employee
remained in the employ of the Corporation during the year for which
the
Bonus is due;
|
ACURA
PHARMACEUTICALS, INC.
|
|||
|
|
||
By: |
/s/
Peter A. Clemens
|
||
|
Name:
Peter A. Clemens
|
||
|
Title:
Senior Vice President and
|
||
|
Chief
Financial Officer
|
||
|
|
||
EMPLOYEE
|
|||
|
|
||
By: |
/s/
Andrew
D. Reddick
|
||
|
Andrew
D. Reddick
|
A. |
The
Corporation and the Employee executed an employment agreement dated
as of
April 5, 2004, which was amended (as amended, the “
Employment
Agreement
”).
|
B. |
The
Corporation and the Employee now desire to further amend the Employment
Agreement as provided herein.
|
(x)
|
the
Employee’s accrued and unpaid Base Salary through and including the date
of terminations;
|
(y)
|
the
Employee’s then accrued and unused vacation through and including the date
of termination; and
|
(z)
|
the
Employee’s then accrued and unpaid Bonus for such year, calculated by
pro-rating the annual Bonus, which would have been payable to the
Employee
but for his termination and assuming full achievement of the Bonus
Criteria for such year, based on the number of days that the Employee
remained in the employ of the Corporation during the year for which
the
Bonus is due;
|
ACURA
PHARMACEUTICALS, INC.
|
||
By:
|
/s/ Andrew D. Reddick | |
Name:
Andrew D. Reddick
|
||
Title:
President and
|
||
Chief Executive Officer
|
||
EMPLOYEE
|
||
By:
|
/s/
Ron J. Spivey
|
|
Ron
J. Spivey
|
A. |
The
Corporation and the Employee executed an employment agreement dated
as of
March 10, 1998, as amended on three occasions (the “
Employment
Agreement
”).
|
B. |
The
Corporation and the Employee now desire to further amend the Employment
Agreement as provided herein.
|
ACURA
PHARMACEUTICALS, INC.
|
||
|
||
By:
|
/s/ Andrew D. Reddick | |
Name:
Andrew D. Reddick
|
||
Title:
President and
|
||
Chief
Executive Officer
|
||
|
||
EMPLOYEE
|
||
By:
|
/s/ Peter A. Clemens | |
Peter
A. Clemens
|
/s/
BDO Seidman, LLP
|
1.
|
I
have reviewed this Annual Report on Form 10-K of Acura Pharmaceuticals,
Inc.;
|
2.
|
Based
on my knowledge, this annual report does not contain any untrue statement
of a material fact or omit to state a material fact necessary to
make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
|
4.
|
The
registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures as
defined
in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control
over
financial reporting for the registrant and
have:
|
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being
prepared;
|
|
(b)
|
Evaluated
the effectiveness of the registrant's disclosure controls and procedures
and presented in this report our conclusions about the effectiveness
of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
|
(c)
|
Disclosed
in this report any change in the registrant's internal control over
financial reporting that occurred during the registrant's most recent
fiscal quarter that has materially affected, or is reasonably likely
to
materially affect, the registrant's internal control over financial
reporting ; and
|
5.
|
The
registrant's other certifying officer and I have disclosed, based
on our
most recent evaluation of internal control over financial reporting,
to
the registrant's auditors and the audit committee of the registrant's
board of directors (or persons performing the equivalent
functions):
|
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant's ability to
record,
process, summarize and report financial information;
and
|
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal
control
over financial reporting.
|
Date:
March 5, 2008
|
/s/
Andrew D. Reddick
|
||
|
Andrew
D. Reddick
|
|
|
President
and Chief Executive Officer
|
1.
|
I
have reviewed this Annual Report on Form 10-K of Acura Pharmaceuticals,
Inc.;
|
2.
|
Based
on my knowledge, this annual report does not contain any untrue statement
of a material fact or omit to state a material fact necessary to
make the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
|
4.
|
The
registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures as
defined
in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control
over
financial reporting for the registrant and
have:
|
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being
prepared;
|
|
(b)
|
Evaluated
the effectiveness of the registrant's disclosure controls and procedures
and presented in this report our conclusions about the effectiveness
of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
|
(c)
|
Disclosed
in this report any change in the registrant's internal control over
financial reporting that occurred during the registrant's most recent
fiscal quarter that has materially affected, or is reasonably likely
to
materially affect, the registrant's internal control over financial
reporting ; and
|
5.
|
The
registrant's other certifying officer and I have disclosed, based
on our
most recent evaluation of internal control over financial reporting,
to
the registrant's auditors and the audit committee of the registrant's
board of directors (or persons performing the equivalent
functions):
|
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant's ability to
record,
process, summarize and report financial information;
and
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal
control
over financial reporting.
|
Date:
March 5, 2008
|
|
|
/s/
Peter
A. Clemens
|
|||
|
Peter
A. Clemens
|
||
|
Senior
Vice President and Chief Financial
Officer
|
March
5, 2008
|
By:
|
/s/
Andrew
D. Reddick
|
|
Andrew
D. Reddick
|
|
|
President
and Chief Executive
Officer |
March
5, 2008
|
By:
|
/s/
Peter
A. Clemens
|
|
Peter
A. Clemens
|
|
|
Senior
Vice President and Chief
Financial Officer |