Delaware
|
22-3367588
|
|
(State
or jurisdiction of
|
(I.R.S.
Employer
|
|
incorporation
or organization)
|
Identification
No.)
|
3
|
||
PART
I
|
||
4
|
||
10
|
||
10
|
||
10
|
||
PART
II
|
||
11
|
||
12
|
||
15
|
||
15
|
||
15
|
||
15
|
||
PART
III
|
||
15
|
||
18
|
||
23
|
||
26
|
||
28
|
||
28
|
·
|
The
development of new products and the expansion of the market for our
current products;
|
·
|
Implementing
aspects of our business plans;
|
·
|
Financing
goals and plans;
|
·
|
Our
existing cash and whether and how long these funds will be sufficient
to
fund our operations; and
|
·
|
Our
raising of additional capital through future equity financings.
|
1(a) |
Business
Development
|
1(b) |
Business
of the Issuer
|
·
|
ENDUROX
EXCEL®
-
Introduced in May 1996 and March
1997
|
·
|
ENDUROX
R4®
Recovery Drink –
Introduced
in February 1999
|
·
|
ACCELERADE®
Sports Drink – Introduced in June
2001
|
·
|
ACCEL
GEL®
Energy Gel – Introduced in February
2004
|
(a)
|
ENDUROX
EXCEL Dietary Supplement
|
ITEM 5. |
MARKET
FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND SMALL BUSINESS
ISSUER
PURCHASES OF EQUITY
SECURITIES.
|
5(a) |
Market
Information.
|
Year
ended December 31, 2006
|
High
|
|
Low
|
||||
First
Quarter
|
$
|
1.24
|
$
|
0.17
|
|||
Second
Quarter
|
$
|
2.75
|
$
|
0.84
|
|||
Third
Quarter
|
$
|
2.08
|
$
|
1.02
|
|||
Fourth
Quarter
|
$
|
1.49
|
$
|
0.99
|
Year
ended December 31, 2005
|
High
|
|
Low
|
||||
First
Quarter
|
$
|
0.92
|
$
|
0.40
|
|||
Second
Quarter
|
$
|
0.63
|
$
|
0.21
|
|||
Third
Quarter
|
$
|
0.35
|
$
|
0.16
|
|||
Fourth
Quarter
|
$
|
0.40
|
$
|
0.08
|
5(b) |
Holders
|
5(c) |
Dividends
|
5(d) |
Recent
Sales of Unregistered
Securities
|
5(d)(i) |
Recent
Sales of Unregistered
Securities
|
ITEM 6. |
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
|
6(a) |
Introduction
|
6(b) |
Results
of Operations - Years Ended December 31, 2006 and 2005
|
6(c) |
Liquidity
and Capital Resources
|
6(d)
|
Impact
of Inflation
|
6(e) |
Seasonality
|
6(f) |
Impact
of Recently Issued Financial Accounting Standards
|
6(g) |
Off-Balance
Sheet Arrangements
|
6(h) |
Critical
Accounting Policies
|
ITEM 7. |
FINANCIAL
STATEMENTS
|
ITEM 8. |
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
AND FINANCIAL DISCLOSURE
|
ITEM 8A |
CONTROLS
AND PROCEDURES
|
(a) |
Evaluation
of Disclosure Controls and
Procedures
|
(b) |
Changes
in Internal Controls Over
Financial Reporting
|
ITEM 8B |
OTHER
INFORMATION
|
ITEM 9. |
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS,
CONTROL PERSONS,
AND
CORPORATE GOVERNANCE;
COMPLIANCE WITH SECTION 16(A) OF THE EXCHANGE
ACT
|
9(a) |
Directors
and Executive Officers
|
Name
|
Position
|
|
Robert
Portman, Ph.D.
|
Chairman
of the Board of Directors, Chief Executive Officer, President,
and Chief
Scientific Officer
|
|
Stephen
P. Kuchen
|
Chief
Financial Officer, Chief Operating Officer, Treasurer, Secretary,
and
Director
|
|
David
Portman
Michael
Cahr
Adam
Mizel
Marc
Particelli
|
Director
Director
1,2
Director
1,2
Director
2
|
1
|
Member
of Audit Committee
|
2
|
Member
of Compensation
Committee
|
9(b) |
Scientific
Advisory Boards
|
9(c) |
Family
Relationships
|
9(d) |
Involvement
in Certain Legal
Proceedings
|
9(e) |
Audit
Committee
|
9(f) |
Audit
Committee Financial Expert
|
9(g) |
Section
16(a) Beneficial Ownership Reporting
Compliance
|
9(i) |
Code
of Ethics
|
ITEM 10. |
EXECUTIVE
COMPENSATION
|
Name
and Principal Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
Non-Equity
Incentive Plan Compen-sation
($)
|
Nonqualified
Deferred Compensa-tion Earnings
($)
|
All
Other Compensa-tion ($)
|
Total
($)
|
|||||||||||||||||||
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
(i)
|
(j)
|
|||||||||||||||||||
Robert
Portman,
Chairman
of the Board, Chief Executive Officer, President and Chief Scientific
Officer
|
2006
|
$
|
275,000
|
(1)
|
—
|
—
|
$
|
103,282
|
(2)
|
—
|
—
|
$
|
0
|
(3)
|
$
|
378,282
|
||||||||||||
|
|
|||||||||||||||||||||||||||
Stephen
P. Kuchen,
Chief
Financial Officer, Chief Operating Officer, Treasurer, Secretary
and
Director
|
2006
|
$
|
137,500
|
(4)
|
$
|
2,000
|
—
|
$
|
32,451
|
(2)
|
—
|
—
|
—
|
$
|
171,951
|
Executive
Officer
|
Number
of Shares of Common Stock Underlying Options
|
Exercise
Price
|
Grant
Date
|
|||||||
Dr.
Robert Portman
|
300,000
|
$
|
0.60
|
February
13, 2006
|
||||||
275,000
|
$
|
1.13
|
December
13, 2006
|
|||||||
Stephen
Kuchen
|
100,000
|
$
|
0.60
|
February
13, 2006
|
||||||
50,000
|
$
|
1.13
|
December
13, 2006
|
Option
Awards
|
Stock
Awards
|
|||||||||||||||||||||||||||
Name
|
Number
of
Securities
Underlying Unexercised Options
(#)
Exercisable
|
Number
of Securities Underlying Unexercised Options
(#)
Unexercisable
|
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options
(#)
|
Option
Exercise Price
($)
|
Option
Expiration Date
|
Number
of Shares or Units of Stock That Have Not Vested
(#)
|
Market
Value of Shares or Units of Stock That Have Not Vested
($)
|
Equity
Incentive Plan Awards: Number of Unearned Shares, Units or Other
Rights
That Have Not Vested
(#)
|
Equity
Incentive Plan Awards: Market or Payout Value of Unearned Shares,
Units or
Other Rights That Have Not Vested
($)
|
|||||||||||||||||||
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
(i)
|
(j)
|
|||||||||||||||||||
Robert
Portman,
|
—
|
|
275,000
|
(1)
|
—
|
$
|
1.13
|
12/12/2011
|
—
|
—
|
—
|
—
|
||||||||||||||||
Chairman
of the Board,
|
—
|
300,000
|
(2)
|
—
|
$
|
0.60
|
02/13/2011
|
|||||||||||||||||||||
Chief Executive Officer, President and |
450,000
|
(3)
|
—
|
—
|
$
|
0.65
|
08/21/2009
|
|||||||||||||||||||||
Chief Scientific Officer |
300,000
|
(4)
|
—
|
—
|
$
|
2.79
|
12/31/2007
|
|||||||||||||||||||||
Stephen
P. Kuchen,
|
—
|
50,000
|
(1)
|
—
|
$
|
1.13
|
12/12/2011
|
—
|
—
|
—
|
—
|
|||||||||||||||||
Chief
Financial Officer, Chief Operating Officer, Treasure, Secretary
and
Director
|
—
90,000
20,000
|
(5)
(6)
|
100,000
30,000
—
|
(2)
(5)
|
—
—
—
|
$
$
$
|
0.60
0.70
1.92
|
02/13/2011
10/01/2009
03/06/2008
|
|
|
|
|
·
|
the
acquisition of beneficial ownership, by any stockholder or group
of
stockholders, not including stockholders who are our officers or
directors
on the date of the employment agreement or any affiliate of such
officer
or director, of shares of our capital stock entitled to cast at
least 50%
of all votes which may be cast in the election of our directors,
or
|
·
|
any
sale of the company, including
|
·
|
any
merger or consolidation involving the company if the stockholders
of the
company prior to the merger hold less than 50% of the shares of
the
combined entity after the merger,
or
|
·
|
the
transfer or sale of all or substantially all of the assets of the
company.
|
Name
|
Fees
Earned or
Paid
in
Cash
($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
Non-Equity
Incentive
Plan
Compensation
($)
|
Nonqualified
Deferred
Compensation
Earnings
($)
|
All
Other
Compensation
($)
|
Total
($)
|
|||||||||||||||
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
|||||||||||||||
David
I. Portman
|
—
|
—
|
$15,333
(1)
|
|
—
|
—
|
—
|
$15,333
|
||||||||||||||
Michael
Cahr
|
—
|
—
|
$15,333(1)
|
|
—
|
—
|
—
|
$15,333
|
||||||||||||||
Gary
Jamison (2)
|
—
|
—
|
—
|
—
|
—
|
—
|
|
—
|
||||||||||||||
Robert
R. Rowbal (3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
ITEM 11. |
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER
MATTERS
|
Name
and Address (1)
|
Common
Stock (2)
Amount
Beneficially Owned
|
Common
Stock (2)
Percentage
of Class
|
|||||
Robert
Portman (3)
Chairman
of the Board and Chief Executive Officer
|
3,211,051
|
22.5
|
%
|
||||
Stephen
P. Kuchen (4)
Vice
President, Chief Financial Officer and a Director
|
169,378
|
1.3
|
%
|
||||
David
I. Portman (5)
Secretary
and a Director
|
518,928
|
3.9
|
%
|
||||
Michael
Cahr (6)
Director
|
242,500
|
1.8
|
%
|
||||
Adam
Mizel (7)
Director
|
371,280
|
2.8
|
%
|
||||
Marc
Particelli
Director
|
54,054
|
*
|
|||||
Executive
Officers and Directors as a group (6 persons)
|
4,567,191
|
31.3
|
%
|
||||
Matthew
Smith (8)
241
Central Park West
New
York, NY 10024
|
1,081,644 | 7.9 | % | ||||
Diker
Management, LLC (9)
745
Fifth Ave., Suite 1409
New
York, NY 10151
|
908,859 | 6.8 | % |
*
|
Less
than one percent
|
(1) |
Except
as otherwise indicated, the address of each person named in the
above
table
is c/o PacificHealth Laboratories, Inc., 100 Matawan Road, Suite
420,
Matawan, NJ 07747.
|
(2) |
Common
Stock which is issuable upon the exercise of a stock option which
is
presently exercisable or which becomes exercisable within sixty
days is
considered outstanding for the purpose of computing the percentage
ownership (x) of persons holding such options, and (y) of officers
and
directors as a group with respect to all options held by officers
and
directors.
|
(3) |
Includes
550,000 shares issuable upon the exercise of options granted under
our
2000 Incentive Stock Option Plan (“2000 Plan”); 300,000 shares issuable
upon the exercise of options granted under his 2004 Employment
Contract
Amendment not under any Incentive Stock plan (“NON-ISO”); and 160,428
shares issuable upon the exercise of warrants issued pursuant to
a 2003
Private Placement. Does not include 200,000 shares of Common Stock
owned
by Jennifer Portman, Dr. Portman’s wife, individually and as Trustee for
his and her minor children, as to which Dr. Portman disclaims beneficial
ownership.
|
(4) |
Includes
53,334 shares issuable upon the exercise of options granted
under our 1995
Plan; 90,000 shares issuable upon the exercise of options granted
not
covered under any Plan (“NON-ISO”) and 5,348 shares issuable upon the
exercise of warrants issued pursuant to a 2003 Private
Placement.
|
(5) |
Includes
45,000 shares issuable upon the exercise of options granted under
our 1995
Plan; 15,000 shares issuable upon the exercise of options granted
under
our 2000 Plan; and 53,476 shares issuable upon the exercise of
warrants
granted pursuant to a 2003 Private
Placement.
|
(6) |
Includes
40,000 shares issuable upon the exercise of options granted under
our 1995
Plan.
|
(7) |
Includes
371,280 shares that are owned by Acquifer Opportunity Fund, L.P.,
of which
Mr. Mizel is the managing principal of the general partner. Mr.
Mizel
disclaims beneficial ownership of the shares owned by Acquifer
Opportunity
Fund, L.P. except to the extent of his pecuniary interest
therein.
|
(8) |
Includes
318,048 shares issuable upon the exercise of warrants granted pursuant
to
a 2003 Private Placement and 127,500 shares issuable upon the exercise
of
warrants granted pursuant to consulting services pursuant to a
2003
Private Placement.
|
(9) |
As
reported in a Schedule 13G filed with the SEC on February 12, 2007,
Diker
GP, LLC, a Delaware limited liability company (“Diker
GP”),
is the general partner of the Diker Value Tech Fund, LP, Diker
Value Tech
QP Fund, LP, Diker Micro-Value Fund, LP, the Diker Micro-Value
QP Fund,
LP, Diker Micro & Small Cap Fund LP, and Diker M&S Cap Master Ltd,
each of which is a Delaware limited partnership (collectively,
the “Diker
Funds”). As the sole general partner of the Diker Funds, Diker GP, has
the
power to vote and dispose of the shares of our common stock owned
by the
Diker Funds and, accordingly, may be deemed the beneficial owner
of such
shares. Pursuant to investment advisory agreements, Diker Management,
LLC,
a Delaware limited liability company (“Diker Management”), serves as the
investment manager of the Diker Funds. Accordingly, Diker Management
may
be deemed the beneficial owner of shares held by the Diker Funds.
Charles
M. Diker and Mark N. Diker are the managing members of each of
Diker GP
and Diker Management, and in that capacity direct their operations.
Therefore, Charles M. Diker and Mark N. Diker may be beneficial
owners of
shares beneficially owned by Diker GP and Diker Management. Diker
GP,
Diker Management, Charles M. Diker and Mark N. Diker disclaim all
beneficial ownership as affiliates of a Registered Investment Adviser,
and
in any case disclaim beneficial ownership except to the extent
of their
pecuniary interest in the shares.
|
Plan
Category
|
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
|
Weighted-average
exercise price of outstanding options, warrants and rights
|
Number
of securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in column
(a))
|
|||||||
(a)
|
(b)
|
(c)
|
||||||||
Equity
compensation plans approved by security holders
|
957,000
|
$
|
1.58
|
527,375
|
||||||
Equity
compensation plans not approved by security holders
|
1,145,000
|
$
|
0.76
|
N/A
|
||||||
Total
|
2,102,000
|
$
|
1.13
|
527,375
|
ITEM 12. |
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
AND DIRECTOR INDEPENDENCE
|
ITEM 13. |
EXHIBITS
|
ITEM 14. |
PRINCIPAL
ACCOUNTANTS’ FEES AND
SERVICES
|
Fee
Category
|
Fiscal
2006
|
Fiscal
2005
|
|||||
Audit
Fees¹
|
$
|
109,575
|
$
|
85,062
|
|||
Audit-Related
Fees2
|
$
|
-
0 -
|
$
|
-
0 -
|
|||
Tax
Fees3
|
$
|
6,500
|
$
|
7,000
|
|||
All
Other Fees4
|
$
|
16,500
|
$
|
6,000
|
|||
TOTAL
|
$
|
132,575
|
$
|
98,062
|
By: /s/ Robert Portman | |||
Robert
Portman, President and Chief Executive
Officer
|
|||
Date:
March 12, 2007
|
/s/
Robert Portman
|
Chairman
of the Board and
|
March
12, 2007
|
||
Robert
Portman
|
Chief
Executive Officer (Principal Executive Officer)
|
|||
/s/
Stephen P. Kuchen
|
Director,
Principal
|
March
12, 2007
|
||
Stephen
P. Kuchen
|
Financial
and Accounting Officer,
Secretary
|
|||
/s/
David I. Portman
|
Director
|
March
12, 2007
|
||
David
I. Portman
|
||||
/s/
Michael Cahr
|
Director
|
March
12, 2007
|
||
Michael
Cahr
|
||||
/s/
Adam Mizel
|
Director
|
March
12, 2007
|
||
Adam
Mizel
|
||||
/s/
Marc Particelli
|
Director
|
March
12, 2007
|
||
Marc
Particelli
|
Exhibit
No.
|
Description
|
Incorporated
by Reference
|
||||
3.1
|
—
|
Certificate
of Incorporation of PacificHealth Laboratories, Inc. and all amendments
thereto
|
A
|
|||
3.2
|
—
|
Amended
and Restated Bylaws of PacificHealth Laboratories, Inc.
|
C
|
|||
3.3
|
—
|
Certificate
of Amendment of Certificate of Incorporation of PacificHealth
Laboratories, Inc.
|
H
|
|||
3.4
|
Certificate
of Designations For Series A Preferred Stock
|
I
|
||||
4.1
|
—
|
Specimen
Common Stock Certificate
|
C
|
|||
4.2
|
—
|
Stock
Purchase Agreement dated June 1, 2001 between Pacific Health
Laboratories, Inc. and Glaxo Wellcome International B.V.
|
E
|
|||
10.1†
|
—
|
Incentive
Stock Option Plan of 1995
|
A
|
|||
10.2
|
—
|
Strategic
Alliance Agreement between the Company and the Institute of Nutrition
and
Food Hygiene
|
A
|
|||
10.3
|
—
|
Exclusive
Licensing Agreement between the Company and the INFH
|
A
|
|||
10.4
|
—
|
Shareholders
Agreement
|
A
|
|||
10.5†
|
—
|
2000
Incentive Stock Option Plan
|
D
|
|||
10.6†
|
Employment
Extension Agreement between PacificHealth Laboratories, Inc. and
Robert
Portman effective September 1, 2004, executed February 28,
2006
|
J
|
||||
10.7
|
Exclusive
Custom Manufacturing Agreement dated January 28, 2005 between
PacificHealth Laboratories, Inc. and an affiliate of Hormel Health
Labs,
LLC (redacted, subject to request for confidential
treatment).
|
K
|
||||
10.8
|
Asset
Purchase Agreement dated February 22, 2006 between PacificHealth
Laboratories, Inc. and Mott’s LLP (redacted, subject to request for
confidential treatment)
|
L
|
||||
10.9
|
License
Agreement dated February 22, 2006 between PacificHealth Laboratories,
Inc.
and Mott’s LLP (redacted, subject to request for confidential
treatment)
|
L
|
||||
10.10
|
Consulting,
License and Noncompetition Agreement dated February 22, 2006 among
PacificHealth Laboratories, Inc., Mott’s LLP, and Robert Portman
(redacted, subject to request for confidential treatment)
|
L
|
10.11†
|
Option
Certificate for grant to Robert Portman
|
M
|
||||
10.12†
|
Option
Certificate for grant to Stephen Kuchen under the PacificHealth
Laboratories, Inc. 1995 Incentive Stock Option Plan.
|
M
|
||||
10.13†
|
Summary
of Compensation for Executive Officers of PacificHealth Laboratories,
Inc.
|
M
|
||||
23.1
|
—
|
Consent
of Weiser LLP
|
*
|
|||
31.1
|
—
|
Rule
13a-14(a) Certification of Chief Executive Officer.
|
*
|
|||
31.2
|
—
|
Rule
13a-14(a) Certification of Chief Financial Officer.
|
*
|
|||
32
|
—
|
Certifications
of Chief Executive Officer and Chief Financial Officer pursuant
to Section
906 of the Sarbanes-Oxley Act of 2002.
|
*
|
* |
Filed
herewith
|
†
|
Management
contract or management compensatory plan or arrangement.
|
A
|
Filed
with Registration Statement on Form SB-2 (Registration No. 333-36379)
(the
“1997 SB-2”) on September 25, 1997.
|
B |
Filed
with Amendment No. 1 to the 1997 SB-2 on October 23,
1997.
|
C |
Filed
with Amendment No. 3 to the 1997 SB-2 on December 17,
1997.
|
D
|
Filed
with Definitive Proxy Statement (Schedule 14A) for annual meeting
held on
August 16, 2000, filed on July 11,
2000.
|
E
|
Filed
with Current Report on Form 8-K dated June 1, 2001, filed on
June 14, 2001.
|
F
|
Filed
with Annual Report on Form 10-KSB for the year ended December 31,
2001.
|
G
|
Filed
with Amendment to Current Report on Form 8-K dated June 1, 2001,
filed July 5, 2001.
|
H
|
Filed
with Annual Report on Form 10-KSB for the year ended December 31,
2002.
|
I |
Filed
as Exhibit 3.1 to Current Report on Form 8-K, dated January 24,
2005,
filed on January 28, 2005.
|
J |
Filed
as Exhibit 10.1 to Current Report on Form 8-K, dated and filed
on
September 9, 2004.
|
K
|
Filed
with Annual Report on Form 10-KSB for the year ended December 31,
2004.
|
L |
Filed
with Annual Report on Form 10-KSB for the year ended December 31,
2005.
|
M |
Filed
as Exhibit to Current Report on Form 8-K, dated December 13, 2006
and
filed on December 19, 2006.
|
Page
|
|
Financial
Statements
|
|
F-1
|
|
F-2
|
|
F-3
|
|
F-4
|
|
F-5
|
|
F-6
|
December
31,
|
|||||||
2006
|
2005
|
||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,564,038
|
$
|
138,487
|
|||
Accounts
receivable, net of allowances of $31,000 and $19,000,
respectively
|
502,234
|
187,835
|
|||||
Inventories
(including consigned inventory of approximately $97,000 and
$162,000,
respectively)
|
1,913,275
|
1,309,779
|
|||||
Prepaid
expenses
|
144,059
|
119,002
|
|||||
Deferred
tax asset
|
—
|
1,278,000
|
|||||
Total
current assets
|
5,123,606
|
3,033,103
|
|||||
Property
and equipment, net
|
74,163
|
65,357
|
|||||
Deposits
|
10,895
|
20,393
|
|||||
TOTAL
ASSETS
|
$
|
5,208,664
|
$
|
3,118,853
|
|||
LIABILITIES
|
|||||||
Current
liabilities:
|
|||||||
Notes
payable
|
$
|
44,327
|
$
|
129,944
|
|||
Accounts
payable and accrued expenses
|
960,757
|
1,546,958
|
|||||
Deferred
revenue
|
244,197
|
369,068
|
|||||
1,249,281
|
2,045,970
|
||||||
Long-term
liabilities:
|
|||||||
Convertible
notes payable - subordinated
|
—
|
500,000
|
|||||
Commitments
|
|||||||
STOCKHOLDERS’
EQUITY
|
|||||||
Preferred
stock:
|
|||||||
Series
A, convertible, no par value; 90,909 shares authorized;
|
|||||||
0
shares issued and outstanding at December 31, 2006 and
|
|||||||
90,909
issued and outstanding at December 31, 2005
|
—
|
966,387
|
|||||
Common
stock, $0.0025 par value, authorized 50,000,000 shares;
|
|||||||
issued
and outstanding 12,776,690 shares at December 31, 2006 and
|
|||||||
10,267,045
shares at December 31, 2005
|
31,942
|
25,667
|
|||||
Additional
paid-in capital
|
17,867,945
|
15,790,335
|
|||||
Accumulated
deficit
|
(13,940,504
|
)
|
(16,209,506
|
)
|
|||
3,959,383
|
572,883
|
||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
5,208,664
|
$
|
3,118,853
|
Years
Ended
December
31,
|
|||||||
2006
|
2005
|
||||||
Revenue:
|
|||||||
Net
product sales
|
$
|
6,209,846
|
$
|
5,444,558
|
|||
Cost
of goods sold:
|
|||||||
Product
sales
|
3,472,955
|
3,409,664
|
|||||
Write-down
of inventory
|
—
|
93,255
|
|||||
3,472,955
|
3,502,919
|
||||||
Gross
profit
|
2,736,891
|
1,941,639
|
|||||
Operating
expenses:
|
|||||||
Selling,
general and administrative
|
2,917,450
|
3,721,567
|
|||||
Research
and development
|
196,020
|
195,242
|
|||||
Depreciation
|
50,905
|
64,638
|
|||||
3,164,375
|
3,981,447
|
||||||
Loss
before other income (expense) and income taxes
|
(427,484
|
)
|
(2,039,808
|
)
|
|||
Other
income (expense):
|
|||||||
Gain
on sale of patents/technology, net of expenses of $90,795
|
3,909,205
|
—
|
|||||
Interest
income
|
96,697
|
4,456
|
|||||
Interest
expense
|
(31,416
|
)
|
(102,134
|
)
|
|||
3,974,486
|
(97,678
|
)
|
|||||
Income
(loss) before income taxes
|
3,547,002
|
(2,137,486
|
)
|
||||
Provision
(benefit) for income taxes
|
1,278,000
|
(1,503,410
|
)
|
||||
Net
income (loss)
|
2,269,002
|
(634,076
|
)
|
||||
Less
preferred dividends
|
(10,425
|
)
|
(18,334
|
)
|
|||
Net
income (loss) applicable to common stockholders
|
$
|
2,258,577
|
$
|
(652,410
|
)
|
||
Net
income (loss) per common share - basic
|
$
|
0.19
|
$
|
(0.06
|
)
|
||
Net
income (loss) per common share - diluted
|
$
|
0.17
|
$
|
(0.06
|
)
|
||
Weighted
average shares outstanding - basic
|
11,906,777
|
10,242,141
|
|||||
Weighted
average shares outstanding - diluted
|
13,397,154
|
10,242,141
|
Preferred
Stock
|
Common
Stock
|
Additional
Paid
In
|
Accumulated
|
|||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||
Balance,
January 1, 2005
|
10,237,045
|
$
|
25,592
|
$
|
15,778,865
|
$
|
(15,557,096
|
)
|
$
|
247,361
|
||||||||||||
Fair
value of stock options issued to non-employees
|
4,945
|
4,945
|
||||||||||||||||||||
Fair
value of stock issued to non-employees
|
30,000
|
75
|
6,525
|
6,600
|
||||||||||||||||||
Preferred
stock issued
|
90,909
|
$
|
1,000,000
|
1,000,000
|
||||||||||||||||||
Issuance
costs related to preferred stock issuance
|
(51,947
|
)
|
(51,947
|
)
|
||||||||||||||||||
Accrued
dividends on preferred stock
|
18,334
|
(18,334
|
)
|
—
|
||||||||||||||||||
Net
loss
|
(634,076
|
)
|
(634,076
|
)
|
||||||||||||||||||
Balance,
December 31, 2005
|
90,909
|
|
966,387
|
10,267,045
|
|
25,667
|
|
15,790,335
|
|
(16,209,506
|
)
|
|
572,883
|
|||||||||
Fair
value of stock options issued
|
189,880
|
189,880
|
||||||||||||||||||||
Preferred
stock converted into common stock
|
(90,909
|
)
|
(966,387
|
)
|
909,091
|
2,273
|
964,114
|
—
|
||||||||||||||
Stock
options/warrants exercised
|
1,600,554
|
4,002
|
923,616
|
927,618
|
||||||||||||||||||
Net
income
|
2,269,002
|
2,269,002
|
||||||||||||||||||||
Balance,
December 31, 2006
|
—
|
$
|
—
|
12,776,690
|
$
|
31,942
|
$
|
17,867,945
|
$
|
(13,940,504
|
)
|
$
|
3,959,383
|
Years
Ended December 31,
|
|||||||
2006
|
2005
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
income (loss)
|
$
|
2,269,002
|
$
|
(634,076
|
)
|
||
Adjustments
to reconcile net income (loss) to net cash used in operating
activities:
|
|||||||
Deferred
tax benefit
|
1,278,000
|
(1,278,000
|
)
|
||||
Depreciation
|
50,905
|
64,638
|
|||||
Allowance
for doubtful accounts
|
12,000
|
12,000
|
|||||
Equity
instrument-based consulting expense
|
189,880
|
11,545
|
|||||
Write-off
of inventory
|
—
|
93,255
|
|||||
Gain
on sale of patents/technology, net of expenses of $90,795
|
(3,909,205
|
)
|
—
|
||||
Changes
in:
|
|||||||
Accounts
receivable
|
(326,399
|
)
|
230,745
|
||||
Prepaid
expenses
|
(25,057
|
)
|
96,089
|
||||
Inventories
|
(603,496
|
)
|
357,030
|
||||
Deposits
|
9,498
|
14,003
|
|||||
Accounts
payable and accrued expenses
|
(586,201
|
)
|
(33,136
|
)
|
|||
Deferred
revenue
|
(124,871
|
)
|
(6,932
|
)
|
|||
Net
cash used in operating activities
|
(1,765,944
|
)
|
(1,072,839
|
)
|
|||
Cash
flows from investing activities:
|
|||||||
Purchase
of property and equipment
|
(59,711
|
)
|
(18,722
|
)
|
|||
Proceeds
from sale of patents and technology, net of expenses of
$90,795
|
3,909,205
|
—
|
|||||
Net
cash provided by (used in) investing activities
|
3,849,494
|
(18,722
|
)
|
||||
Cash
flows from financing activities:
|
|||||||
Issuance
of preferred stock
|
—
|
1,000,000
|
|||||
Fees
in connection with issuance of preferred stock
|
—
|
(51,947
|
)
|
||||
Proceeds
from common stock options/warrants exercised
|
927,618
|
—
|
|||||
Proceeds
from issuance of convertible notes payable
|
—
|
500,000
|
|||||
Repayments
of convertible notes payable
|
(500,000
|
)
|
—
|
||||
Proceeds
of note payable
|
861,200
|
5,235,927
|
|||||
Repayment
of note payable
|
(946,817
|
)
|
(5,479,764
|
)
|
|||
Net
cash provided by financing activities
|
342,001
|
1,204,216
|
|||||
Net
increase in cash and cash equivalents
|
2,425,551
|
112,655
|
|||||
Cash
and cash equivalents at beginning of year
|
138,487
|
25,832
|
|||||
Cash
and cash equivalents at end of year
|
$
|
2,564,038
|
$
|
138,487
|
|||
Supplemental
disclosures of cash flow information:
|
|||||||
Cash
paid for interest
|
$
|
48,082
|
$
|
85,468
|
|||
Cash
paid for income taxes
|
$
|
2,609
|
$
|
2,115
|
|||
|
|||||||
Noncash
investing activity:
|
|||||||
Schedule
of non-cash financing activity:
|
|||||||
Conversion
of 90,909 shares of Series A Preferred Stock into 909,091 shares
of common
stock
|
$
|
966,387
|
$
|
—
|
|||
Accrued
dividends on preferred stock
|
$
|
—
|
$
|
18,334
|
[1] |
The
Company:
|
[2] |
Cash
and cash equivalents:
|
[3] |
Allowance
for doubtful accounts:
|
[4] |
Inventories:
|
[5] |
Property
and equipment:
|
[6] |
Earnings
(loss) per share:
|
[7] |
Revenue
recognition:
|
[8] |
Research
and development:
|
[9] |
Advertising
costs:
|
[10] |
Stock-based
compensation:
|
Year
Ended
December
31,
2005
|
|||||
Reported
net loss applicable to common stockholders
|
$
|
(652,410
|
)
|
||
Stock-based
employee compensation determined under
|
|||||
the
fair value-based method
|
(143,113
|
)
|
|||
Pro
forma net loss
|
$
|
(795,523
|
)
|
||
Basic
and diluted net loss per share:
|
|||||
As
reported
|
$
|
(0.06
|
)
|
||
Pro
forma
|
$
|
(0.08
|
)
|
[11] |
Segment
information:
|
[12] |
Income
taxes:
|
[13] |
Impairment
of long-lived assets:
|
[14] |
Comprehensive
income (loss):
|
[15] |
Recent
accounting pronouncements:
|
[16] |
Use
of estimates:
|
2006
|
2005
|
|||||||
Raw
materials (at contract manufacturer)
|
$
|
531,995
|
$
|
102,587
|
||||
Work
in process (at contract manufacturer)
|
77,771
|
8,847
|
||||||
Packaging
supplies (at third party warehouse)
|
41,378
|
46,880
|
||||||
Finished
goods (at third party warehouse)
|
1,165,188
|
989,814
|
||||||
Finished
goods (on consignment)
|
96,943
|
161,651
|
||||||
$
|
1,913,275
|
$
|
1,309,779
|
2006
|
2005
|
|||||||
Furniture
and equipment
|
$
|
431,624
|
$
|
388,414
|
||||
Molds
and dies
|
137,327
|
120,826
|
||||||
568,951
|
509,240
|
|||||||
Less
accumulated depreciation
|
494,788
|
443,883
|
||||||
$
|
74,163
|
$
|
65,357
|
2006
|
2005
|
|||||||
Installment
note payable to insurance finance company
|
||||||||
due
in monthly installments of $7,104, including
|
||||||||
interest
at 6.50% through February 2007
|
$
|
7,104
|
$
|
—
|
||||
Installment
note payable to insurance finance company
|
||||||||
due
in monthly installments of $3,722, including
|
||||||||
interest
at 7.53% through October 2007
|
37,223
|
—
|
||||||
Installment
note payable to insurance finance company
|
||||||||
due
in monthly installments of $8,235, including
|
||||||||
interest
at 5.57% through January 2006
|
—
|
8,197
|
||||||
Installment
note payable to insurance finance company
|
||||||||
due
in monthly installments of $4,913, including
|
||||||||
interest
at 6.50% through September 2006
|
—
|
47,649
|
||||||
$
|
44,327
|
$
|
55,846
|
[1] |
Employment
agreement:
|
[2] |
Lease:
|
Years
Ending
December
31,
|
|||||
2007
|
$
|
118,125
|
|||
2008
|
140,250
|
||||
2009
|
140,250
|
||||
2010
|
143,000
|
||||
2011
|
148,500
|
||||
2012
|
75,625
|
||||
$
|
765,750
|
Option
Shares
|
Vested
Shares
|
Exercise
Price
Per
Common
Share
|
Weighted
Average
Exercise
Price
Per
Share
Outstanding
|
||||||||||
Balance,
January 1, 2005
|
2,832,500
|
1,801,500
|
$0.313
- $4.34
|
$1.20
|
|||||||||
Granted/vested
during the year
|
—
|
395,500
|
$0.65
- $2.79
|
$1.25
|
|||||||||
Expired
during the year
|
(862,500
|
)
|
(450,000
|
)
|
$0.65
- $3.77
|
$1.33
|
|||||||
Balance,
December 31, 2005
|
1,970,000
|
1,747,000
|
$0.313
- $4.34
|
$1.11
|
|||||||||
Granted/vested
during the year
|
913,000
|
193,000
|
$0.20
- $1.13
|
$0.81
|
|||||||||
Exercised
during the year
|
(648,000
|
)
|
(648,000
|
)
|
$0.313
- $1.00
|
$0.46
|
|||||||
Expired
during the year
|
(223,500
|
)
|
(222,500
|
)
|
$0.20
- $4.34
|
$1.63
|
|||||||
Balance,
December 31, 2006
|
2,011,500
|
1,069,500
|
$0.20
- $3.80
|
$1.12
|
|||||||||
Aggregate
Intrinsic Value, December 31, 2006
|
$
|
647,655
|
$
|
330,125
|
Range
of
Exercise
Prices
|
Number
Outstanding
|
Weighted
Average
Remaining
Contractual
Life
(in Years)
|
Weighted
Average
Exercise
Price
|
Number
Exercisable
|
Weighted
Average
Exercise
Price
|
||||||||||||
$0.31
- $2.00
|
1,678,500
|
3.59
|
$0.77
|
736,500
|
$0.73
|
||||||||||||
$2.01
- $4.00
|
333,000
|
0.94
|
$2.89
|
333,000
|
$2.89
|
||||||||||||
2,011,500
|
3.15
|
$1.12
|
1,069,500
|
$1.40
|
Option
Shares
|
Vested
Shares
|
Exercise
Price
Per
Common
Share
|
Weighted
Average
Exercise
Price
Per
Share
Outstanding
|
|||||||||||
Balance,
January 1, 2005
|
217,375
|
217,375
|
$0.31
- $6.30
|
$2.01
|
||||||||||
Granted/vested
during the year
|
25,500
|
25,500
|
$0.20
- $0.28
|
$0.26
|
||||||||||
Expired
during the year
|
(87,375
|
)
|
(87,375
|
)
|
$1.06
- $3.50
|
$2.29
|
||||||||
Balance,
December 31, 2005
|
155,500
|
155,500
|
$0.20
- $6.30
|
$1.57
|
||||||||||
Granted/vested
during the year
|
90,500
|
90,500
|
$0.20
- $1.23
|
$0.23
|
||||||||||
Exercised
during the year
|
(58,000
|
)
|
(58,000
|
)
|
$0.20
|
$0.20
|
||||||||
Expired
during the year
|
(97,500
|
)
|
(97,500
|
)
|
$0.89
- $6.30
|
$1.34
|
||||||||
Balance,
December 31, 2006
|
90,500
|
90,500
|
$0.20
- $4.88
|
$1.35
|
Range
of
Exercise
Prices
|
Number
Outstanding
and
Exercisable
|
Weighted
Average
Remaining
Contractual
Life
(in Years)
|
Weighted
Average
Exercise
Price
|
||||||||
$0.20
- $2.00
|
70,000
|
2.45
|
$
|
0.38
|
|||||||
$4.01
- $6.30
|
20,500
|
0.29
|
$
|
4.67
|
|||||||
90,500
|
1.96
|
$
|
1.35
|
Warrants
|
Exercise
Price
Per
Common
Share
|
Weighted
Average
Exercise
Price
Per
Common
Share
|
|||||||||
Balance,
January 1, 2005
|
2,293,275
|
$0.63
- $3.44
|
$0.70
|
||||||||
Expired
during the year
|
(22,000
|
)
|
$3.44
|
$3.44
|
|||||||
Balance,
December 31, 2005
|
2,271,275
|
$0.63
- $0.88
|
$0.67
|
||||||||
Exercised
during the year
|
(919,565
|
)
|
$0.63
- $0.85
|
$0.72
|
|||||||
Balance,
December 31, 2006
|
1,351,710
|
$0.63
- $0.88
|
$0.64
|
2006
|
2005
|
|||||||||||||
Amount
|
Percent
|
Amount
|
Percent
|
|||||||||||
U.S.
federal income tax provision
|
||||||||||||||
(benefit)
at federal statutory rate
|
$
|
1,241,450
|
35
|
%
|
$
|
(748,120
|
)
|
35
|
%
|
|||||
Effect
of state taxes, net of
|
||||||||||||||
federal
benefit
|
212,820
|
6
|
%
|
(128,249
|
)
|
6
|
%
|
|||||||
Change
in valuation allowance
|
(11,000
|
)
|
0
|
%
|
(597,000
|
)
|
28
|
%
|
||||||
Other
|
(165,270
|
)
|
(5
|
%)
|
(30,041
|
)
|
1
|
%
|
||||||
$
|
1,278,000
|
36
|
%
|
$
|
(1,503,410
|
)
|
70
|
%
|
2006
|
|
|
2005
|
|||||
Net
operating loss carryforwards
|
$
|
4,380,000
|
$
|
5,653,000
|
||||
Inventory
reserve
|
224,000
|
289,000
|
||||||
Other
|
49,000
|
—
|
||||||
Valuation
allowance
|
(4,653,000
|
)
|
(4,664,000
|
)
|
||||
Deferred
tax asset
|
$
|
-0-
|
$
|
1,278,000
|
[1] |
Concentrations
of credit risk:
|
[2] |
Fair
value of financial
instruments:
|
[3] |
Major
customers:
|
[4] |
Major
vendors:
|
2006
|
2005
|
|||||||
United
States
|
$
|
5,751,148
|
$
|
5,005,765
|
||||
Canada
|
178,556
|
201,359
|
||||||
Other
|
280,142
|
237,434
|
||||||
Total
|
$
|
6,209,846
|
$
|
5,444,558
|
[1] |
Common
Stock:
|