AMERICAN BIO MEDICA CORP - Quarter Report: 2008 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D. C. 20549
FORM
10-Q
x Quarterly
report under Section 13 or 15(d) of the Securities Exchange Act of
1934
For the quarterly period ended September
30, 2008
¨ Transition
report under Section 13 or 15(d) of the Securities Exchange Act of
1934
For the transition period from to
Commission
File Number: 0-28666
AMERICAN
BIO MEDICA CORPORATION
|
(Exact
name of registrant as specified in its
charter)
|
New
York
|
14-1702188
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
122
Smith Road, Kinderhook, New York
|
12106
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
518-758-8158
|
(Registrant's
telephone number, including area
code)
|
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or such shorter period that the registrant was required
to
file such reports), and (2) has been subject to such filing requirements
for the
past 90 days x
Yes
¨
No
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨ Accelerated
filer ¨
Non-accelerated
filer ¨ Smaller
reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act) ¨
Yes
x
No
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date:
21,744,768
Common Shares as of November 12 2008
American
Bio Medica Corporation
Index
to Quarterly Report on Form 10-Q
For
the quarter ended September 30, 2008
PAGE
|
||
PART
I – FINANCIAL INFORMATION
|
|
|
Item
1.
|
Financial
Statements
|
|
Balance
Sheets as of September 30, 2008 and December 31, 2007
|
3
|
|
Statements
of Operations for the nine months ended September 30, 2008 and
September
30, 2007
|
4
|
|
Statements
of Operations for the three months ended September 30, 2008 and
September
30, 2007
|
5
|
|
Statements
of Cash Flows for the nine months ended September 30, 2008 and
September
30, 2007
|
6
|
|
Notes
to Financial Statements
|
7
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
11
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
16
|
Item
4.
|
Controls
and Procedures
|
16
|
PART
II – OTHER INFORMATION
|
||
Item
1.
|
Legal
Proceedings
|
16
|
Item
1A.
|
Risk
Factors
|
16
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
16
|
Item
3.
|
Defaults
Upon Senior Securities
|
17
|
Item
4
|
Submission
of Matters to a Vote of Security Holders
|
17
|
Item
5.
|
Other
Information
|
17
|
Item
6.
|
Exhibits
|
17
|
Signatures
|
18
|
2
PART
I - FINANCIAL INFORMATION
Item
1. Financial Statements
American
Bio Medica Corporation
|
|||||||
Balance
Sheets
|
|||||||
September 30,
|
December 31,
|
||||||
2008
|
2007
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
391,000
|
$
|
336,000
|
|||
Accounts
receivable - net of allowance for doubtful accounts of $105,000
at both
September 30, 2008 and December 31, 2007
|
1,765,000
|
1,365,000
|
|||||
Inventory
– net of reserve for slow moving and obsolete inventory of $250,000
at
both September 30, 2008 and December 31, 2007
|
5,433,000
|
4,994,000
|
|||||
Prepaid
and other current assets
|
114,000
|
181,000
|
|||||
Total
current assets
|
7,703,000
|
6,876,000
|
|||||
Property,
plant and equipment, net
|
2,043,000
|
2,267,000
|
|||||
Debt
issuance costs
|
120,000
|
||||||
Other
assets
|
7,000
|
7,000
|
|||||
Total
assets
|
$
|
9,873,000
|
$
|
9,150,000
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable
|
$
|
1,432,000
|
$
|
1,403,000
|
|||
Accrued
expenses
|
657,000
|
220,000
|
|||||
Wages
payable
|
399,000
|
332,000
|
|||||
Patent
sublicense current
|
50,000
|
||||||
Line
of credit
|
419,000
|
723,000
|
|||||
Current
portion of long term debt
|
128,000
|
121,000
|
|||||
Current
portion of unearned grant
|
10,000
|
10,000
|
|||||
Total
current liabilities
|
3,045,000
|
2,859,000
|
|||||
Other
liabilities
|
102,000
|
48,000
|
|||||
Long-term
debt
|
1,761,000
|
1,107,000
|
|||||
Unearned
grant
|
40,000
|
40,000
|
|||||
Total
liabilities
|
4,948,000
|
4,054,000
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
Stockholders'
equity:
|
|||||||
Preferred
stock; par value $.01 per share; 5,000,000 shares authorized,
none issued
and outstanding at September 30, 2008 and December 31,
2007
|
|||||||
Common
stock; par value $.01 per share; 50,000,000 shares authorized;
21,744,768
issued and outstanding at both September 30, 2008 and December
31, 2007
|
217,000
|
217,000
|
|||||
Additional
paid-in capital
|
19,273,000
|
19,267,000
|
|||||
Accumulated
deficit
|
(14,565,000
|
)
|
(14,388,000
|
)
|
|||
Total
stockholders’ equity
|
4,925,000
|
5,096,000
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
9,873,000
|
$
|
9,150,000
|
The
accompanying notes are an integral part of the financial
statements
3
American
Bio Medica Corporation
|
||||||||||
Statements
of Operations
|
||||||||||
(Unaudited)
|
||||||||||
For The Nine Months Ended
|
||||||||||
September 30
|
||||||||||
2008
|
2007
|
|||||||||
Net
sales
|
$
|
10,368,000
|
$
|
10,523,000
|
||||||
Cost
of goods sold
|
5,822,000
|
6,383,000
|
||||||||
Gross
profit
|
4,546,000
|
4,140,000
|
||||||||
Operating
expenses:
|
||||||||||
Research
and development
|
445,000
|
520,000
|
||||||||
Selling
and marketing
|
2,197,000
|
2,334,000
|
||||||||
General
and administrative
|
1,973,000
|
2,149,000
|
||||||||
4,615,000
|
5,003,000
|
|||||||||
Operating
loss
|
(69,000
|
)
|
(863,000
|
)
|
||||||
Other
income (expense):
|
||||||||||
Interest
income
|
3,000
|
7,000
|
||||||||
Interest
expense
|
(107,000
|
)
|
(106,000
|
)
|
||||||
Other
expense
|
(4,000
|
)
|
||||||||
(108,000
|
)
|
(99,000
|
)
|
|||||||
Loss
before tax
|
(177,000
|
)
|
(962,000
|
)
|
||||||
Income
tax
|
||||||||||
Loss
after tax
|
$
|
(177,000
|
)
|
$
|
(962,000
|
)
|
||||
Basic
and diluted loss per common share
|
$
|
(0.01
|
)
|
$
|
(0.04
|
)
|
||||
Weighted
average number of shares outstanding – basic and diluted
|
21,744,768
|
21,733,779
|
The
accompanying notes are an integral part of the financial
statements
4
American
Bio Medica Corporation
|
||||||||||
Statements
of Operations
|
||||||||||
(Unaudited)
|
||||||||||
For The Three Months Ended
|
||||||||||
September 30
|
||||||||||
2008
|
2007
|
|||||||||
Net
sales
|
$
|
3,604,000
|
$
|
3,912,000
|
||||||
Cost
of goods sold
|
2,104,000
|
2,493,000
|
||||||||
Gross
profit
|
1,500,000
|
1,419,000
|
||||||||
Operating
expenses:
|
||||||||||
Research
and development
|
128,000
|
173,000
|
||||||||
Selling
and marketing
|
713,000
|
818,000
|
||||||||
General
and administrative
|
532,000
|
641,000
|
||||||||
1,373,000
|
1,632,000
|
|||||||||
Operating
income/(loss)
|
127,000
|
(213,000
|
)
|
|||||||
Other
income (expense):
|
||||||||||
Interest
income
|
2,000
|
|||||||||
Interest
expense
|
(41,000
|
)
|
(41,000
|
)
|
||||||
(41,000
|
)
|
(39,000
|
)
|
|||||||
Income/(Loss)
before tax
|
86,000
|
(252,000
|
)
|
|||||||
Income
tax
|
||||||||||
Income/(Loss)
after tax
|
$
|
86,000
|
$
|
(252,000
|
)
|
|||||
Basic
and diluted income/(loss) per common share
|
$
|
0.00
|
(0.01
|
)
|
||||||
Weighted
average number of shares outstanding – basic
|
21,744,768
|
21,744,768
|
||||||||
Dilutive
effect of stock options and warrants
|
16,934
|
|||||||||
Weighted
average number of shares outstanding – fully diluted
|
21,761,702
|
21,744,768
|
The
accompanying notes are an integral part of the financial
statements
5
American
Bio Medica Corporation
|
|||||||
Statements
of Cash Flows
|
|||||||
(Unaudited)
|
|||||||
For
The Nine Months Ended
|
|||||||
September
|
|||||||
2008
|
2007
|
||||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(177,000
|
)
|
$
|
(962,000
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|||||||
Depreciation
|
268,000
|
338,000
|
|||||
Loss
on disposal of fixed assets
|
4,000
|
||||||
Amortization
of debt issuance costs
|
5,000
|
||||||
Non-cash
compensation expense
|
26,000
|
||||||
Changes
in:
|
|||||||
Accounts
receivable
|
(399,000
|
)
|
(753,000
|
)
|
|||
Inventory
|
(439,000
|
)
|
643,000
|
||||
Prepaid
and other current assets
|
67,000
|
(24,000
|
)
|
||||
Accounts
payable
|
29,000
|
12,000
|
|||||
Accrued
expenses
|
437,000
|
(165,000
|
)
|
||||
Other
liabilities
|
4,000
|
||||||
Wages
payable
|
67,000
|
137,000
|
|||||
Net
cash used in operating activities
|
(134,000
|
)
|
(748,000
|
)
|
|||
Cash
flows from investing activities:
|
|||||||
Purchase of property, plant and equipment
|
(48,000
|
)
|
(632,000
|
)
|
|||
Net
cash used in investing activities
|
(48,000
|
)
|
(632,000
|
)
|
|||
Cash
flows from financing activities:
|
|||||||
Proceeds from exercise of options
|
23,000
|
||||||
Long term debt payments
|
(89,000
|
)
|
(74,000
|
)
|
|||
Proceeds from debt financing
|
539,000
|
||||||
Proceeds from line of credit
|
2,129,000
|
900,000
|
|||||
Proceeds from long-term debt financing
|
750,000
|
||||||
Debt issuance costs
|
(120,000
|
)
|
|||||
Line of credit payments
|
(2,433,000
|
)
|
(273,000
|
)
|
|||
Net
cash provided by financing activities
|
237,000
|
1,115,000
|
|||||
Net
increase / (decrease) in cash and cash
equivalents
|
55,000
|
(265,000
|
)
|
||||
Cash
and cash equivalents - beginning of period
|
336,000
|
641,000
|
|||||
Cash
and cash equivalents - end of period
|
$
|
391,000
|
$
|
376,000
|
|||
Supplemental
disclosures of cash flow information
|
|||||||
Cash
paid during period for interest
|
$
|
107,000
|
$
|
106,000
|
|||
Purchase
of property, plant and equipment, financing through capital
lease
|
$ |
$
|
17,000
|
||||
Warrants
issued in connection with long term debt financing
|
$
|
6,000
|
$
|
The
accompanying notes are an integral part of the financial
statements
6
Notes
to
financial statements
September
30, 2008
Note
A - Basis of Reporting
The
accompanying unaudited financial statements of American Bio Medica Corporation
(the “Company”) have been prepared in accordance with generally accepted
accounting principles in the United States of America for interim financial
information and in accordance with the instructions to Form 10-Q and Regulation
S-X. Accordingly, they do not include all information and footnotes required
by
generally accepted accounting principles for complete financial statement
presentation. In the opinion of management, the financial statements include
all
normal, recurring adjustments, which are considered necessary for a fair
presentation of the financial position of the Company at September 30,
2008, and
the results of its operations for the three and nine month periods ended
September 30, 2008 and September 30, 2007, and cash flows for the nine
month
periods ended September 30, 2008 and 2007.
Operating
results for the three and nine months ended September 30, 2008 are not
necessarily indicative of results that may be expected for the year ending
December 31, 2008. Amounts at December 31, 2007 are derived from the Company’s
audited financial statements. For further information, refer to the audited
financial statements and notes thereto included in the Company’s Annual Report
on Form 10-KSB for the fiscal year ended December 31, 2007.
During
the nine months ended September 30, 2008, there were no significant changes
to
the Company's critical accounting policies, which are included in the Company's
Annual Report on Form 10-KSB for the year ended December 31, 2007.
The
preparation of these financial statements requires the Company to make
estimates
and judgments that affect the reported amounts of assets, liabilities,
revenues
and expenses, and related disclosure of contingent assets and liabilities.
On an
on-going basis, the Company evaluates its estimates, including those related
to
product returns, bad debts, inventories, income taxes, warranty obligations,
contingencies and litigation. The Company bases its estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances; the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are
not
readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
These
unaudited financial statements have been prepared assuming that the Company
will
continue as a going concern and, accordingly, do not include any adjustments
that might result from the outcome of this uncertainty. The Company's
independent registered public accounting firm's report of the financial
statements included in the Company's Annual Report on Form 10-KSB for the
year
ended December 31, 2007, contained an explanatory paragraph regarding the
Company's ability to continue as a going concern.
Recently
Adopted Accounting Standards
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements” (“SFAS
No. 157”). SFAS No. 157 established a common definition for fair value to be
applied to U.S. GAAP guidance requiring use of fair value, established
a
framework for measuring fair value, and expanded disclosure about such
fair
value measurements. SFAS No. 157 became effective for our financial assets
and
liabilities on January 1, 2008. The FASB has deferred the implementation
of the provisions of SFAS No. 157 relating to certain nonfinancial assets
and
liabilities until January 1, 2009. SFAS No. 157 did not materially affect
how we
determine fair value.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities Including an Amendment of SFAS
No.
115” (“SFAS No. 159”). This new standard permits entities to choose to measure
many financial instruments and certain warranty and insurance contracts
at fair
value on a contract-by-contract basis. SFAS No. 159 became effective on
January
1, 2008. We have not elected the fair value option for any of our existing
financial instruments on the effective date and have not determined whether
or
not we will elect this option for any eligible financial instruments we
acquire
in the future.
In
December 2007, the FASB issued SFAS No. 141(R), “Business Combinations” (“SFAS
No. 141(R)”) and SFAS No. 160, “Noncontrolling Interests in Consolidated
Financial Statements” (“SFAS No. 160”). Effective for the Company as of January
1, 2009, SFAS No. 141(R) requires the acquiring entity in a business combination
to recognize all (and only) the assets acquired and liabilities assumed
in the
transaction; establishes the acquisition-date fair value as the measurement
objective for all assets acquired and liabilities assumed; and requires
the
acquirer to disclose to investors and other users all of the information
they
need to evaluate and understand the nature and financial effect of the
business
combination. Effective January 1, 2009, SFAS No. 160 requires all entities
to
report noncontrolling (minority) interests in subsidiaries as equity in
the
consolidated financial statements. Moreover, SFAS No. 160 eliminates the
diversity that currently exists in accounting for transactions between
an entity
and noncontrolling interests by requiring they be treated as equity
transactions. Management is evaluating the impact of adopting SFAS No.
141(R)
and SFAS No. 160, if any, on the Company’s financial statements.
7
In
March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities – an Amendment of FASB Statement No. 133” (“SFAS No.
161”). SFAS No. 161 expands the disclosure requirements in SFAS No. 133,
regarding an entity’s derivative instruments and hedging activities. SFAS No.
161 is effective on January 1, 2009. Management is evaluating the impact
of
adopting SFAS No. 161, if any, on the Company’s financial
statements.
In
May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles” (“SFAS No. 162”). SFAS No. 162 identifies the sources of
accounting principles and the framework for selecting the principles to
be used
in the preparation of financial statements of nongovernmental entities
that are
presented in conformity with generally accepted accounting principles (GAAP)
in
the United States (the GAAP hierarchy). SFAS No. 162 shall be effective
60 days
following the SEC’s approval of the Public Company Accounting Oversight Board
(PCAOB) amendments to AU Section 411, “The Meaning of Present Fairly in
Conformity With Generally Accepted Accounting Principles”. Management is
evaluating the impact of adopting SFAS No. 162, if any, on the Company’s
financial statements.
In
May
2008, the FASB issued FASB Statement No. 163, “Accounting for Financial
Guarantee Insurance Contracts” (“SFAS No. 163”), which clarifies how FASB
Statement No. 60, “Accounting and Reporting by Insurance Enterprises”, applies
to financial guarantee insurance contracts issued by insurance enterprises.
The
standard is effective for financial statements issued for fiscal years
beginning
after December 15, 2008, including interim periods in that year. Management
is
evaluating the impact of adopting SFAS No. 163, if any, on the Company’s
financial statements.
Note
B – Net Income / (Loss) Per Common Share
Basic
net
income or loss per share is calculated by dividing the net income or loss
by the
weighted average number of outstanding common shares during the period.
Diluted
net income per share includes the weighted average dilutive effect of stock
options and warrants.
Potential
common shares outstanding as of September 30, 2008 and 2007:
September 30,
2008
|
September 30,
2007
|
||||||
Warrants
|
224,900
|
150,000
|
|||||
Options
|
3,762,080
|
3,968,080
|
For
the
three months ended September 30, 2008, the number of securities included
in the
diluted EPS was 3,895,146. For the three months ended September 30, 2007,
the
number of securities not included in the diluted EPS because the effect
would
have been anti-dilutive was 4,118,080.
For
the
nine months ended September 30, 2008 and 2007, the number of securities
not
included in the diluted EPS because the effect would have been anti-dilutive
was
3,986,080 and 4,118,080 respectively.
Note
C – Litigation
The
Company has been named in legal proceedings in connection with matters
that
arose during the normal course of its business, and that in the Company’s
opinion are not material. While the ultimate result of any litigation cannot
be
determined, it is management’s opinion, based upon consultation with counsel,
that it has adequately provided for losses that may be incurred related
to these
claims. If the Company is unsuccessful in defending any or all of these
claims,
resulting financial losses could have an adverse effect on the financial
position, results of operations and cash flows of the Company.
Note
D – Lines of Credit and Long Term Debt
On
November 6, 2006, the Company obtained a real estate mortgage related to
its
facility in Kinderhook, New York. The loan through First Niagara Financial
Group
(“FNFG”) is in the amount of $775,000 and has a term of 10 years with a 20 year
amortization. The interest rate is fixed at 7.50% for the first 5 years.
Beginning with year 6 and through the end of the loan term, the rate changes
to
2% above the Federal Home Loan Bank of New York 5 year term, 15 year
Amortization Advances Rate. The Company’s monthly payment is $6,293 and payments
commenced on January 1, 2007, with the final payment being due on December
1,
2016. The loan is collateralized by the Company's facility in Kinderhook,
New
York and its personal property. The amount outstanding on this mortgage
was
$744,000 and $758,000 at September 30, 2008 and December 31, 2007,
respectively.
8
The
Company has a Line of Credit with FNFG. As disclosed in the Company’s Current
Report on Form 8-K filed with the Securities and Exchange Commission (the
“Commission”) on August 8, 2008, effective August 1, 2008, the Company and FNFG
entered into an amendment to the original Loan Documents (the “Amendment”). The
Amendment combined two lines of credit already in place with FNFG into
one line
of credit (the “Line of Credit”) along with amending certain terms related to
the combined Line of Credit. Pursuant to the Amendment, the maximum amount
available under the Line of Credit is $750,000, and the maturity date of
the
Line of Credit is April 1, 2009. The interest rate on the Line of Credit
is
prime plus 1%. Pursuant to the Amendment, the Company is required to maintain
certain financial covenants; the Company’s monthly net loss must not exceed
$75,000 during any month and, while any loans or commitments are outstanding
and
due FNFG, the Company must maintain a minimum debt service coverage ratio
of
1.10x, to be measured at December 31, 2008. The minimum debt service coverage
ratio is defined as net income plus interest expense plus depreciation
plus
expense related to the amortization of derivative securities divided by
required
principal payments over the preceding twelve months plus interest expense.
There
is no requirement for annual repayment of all principal on this Line of
Credit;
it is payable on demand. The purpose of this Line of Credit is to provide
working capital. The amount outstanding on the Line of Credit was $419,000
at
September 30, 2008. At December 31, 2007, the Line of Credit was two separate
lines of credit and the amount outstanding was $690,000 under one line
and
$33,000 under the other line, totaling $723,000.
On
January 22, 2007, the Company entered into a Term Note with FNFG in the
amount
of $539,000 (the “Note”). The term of the Note is 5 years with a fixed interest
rate of 7.17%. The Company’s monthly payment is $10,714 and payments commenced
on February 1, 2007, with the final payment being due on January 23, 2012.
The
Company has the option of prepaying the Note in full or in part at any
time
during the term without penalty. The loan is secured by Company assets
now owned
or hereafter acquired. The proceeds received were used for the purchase
of
automation equipment to enhance the Company's manufacturing process in
its New
Jersey facility. The amount outstanding on this Note was $381,000 and $455,000
at September 30, 2008 and December 31, 2007, respectively.
Any
default or breach by the Company of any of the terms, covenants and conditions
set forth in any Loan Document related to the Note, the Line of Credit
or the
Mortgage (together the “Credit Facilities”) shall constitute a default and FNFG
may declare all sums outstanding under the Credit Facilities due and payable
without notice or demand. In the event of default, the Company will be
subject
to an interest rate of prime plus 6% under its Line of Credit.
Under
the
Loan Documents, as amended by the Amendment, the Company was required to
sell at
least $500,000 in subordinated debentures by September 1, 2008, on terms
consistent with a term sheet agreed to between the Company and Cantone
Research,
Inc. of Tinton Falls, New Jersey (“Cantone”) for the private placement of an
issue of 10% Subordinated Convertible Debentures, Series A (the “Series
A
Debentures”).
On
August
15, 2008, the Company completed its offering of the Series A Debentures
and
received gross proceeds of $750,000 in principal amount of Series A Debentures
(see Current Report on Form 8-K and amendment on Form 8-K/A-1 filed with
the
Commission on August 8, 2008 and August 18, 2008 respectively). The net
proceeds
of the offering of Series A Debentures were $630,000. The securities issued
in
this transaction were sold pursuant to the exemption from registration
afforded
by Rule 506 under Regulation D ("Regulation D") as promulgated by the Commission
under the Securities Act of 1933, as amended (the "1933 Act"), and/or Section
4(2) of the 1933 Act.
The
Series A Debentures accrue interest at a rate of 10% per annum (payable
by the
Company semi-annually) and mature on August 1, 2012. The payment of principal
and interest on the Series A Debentures is subordinate and junior in right
of
payment to all Senior Obligations, as defined under the Series A Debentures.
Holders of the Series A Debentures will have a right of conversion of the
principal amount of the Series A Debentures into shares (the “Conversion
Shares”) of the common stock of the Company (“Common Stock”), at a conversion
rate of 666.67 shares per $500 in principal amount of the Series A Debentures
(representing a conversion price of approximately $0.75 per share). This
conversion right can be exercised at any time, commencing the earlier of
(a) one
hundred twenty (120) days after the date of the Series A Debentures, or
(b) the
effective date of a Registration Statement to be filed by the Company with
respect to the Conversion Shares. The Company has the right to redeem any
Series
A Debentures that have not been surrendered for conversion at a price equal
to
the Series A Debentures’ face value plus $0.05 per underlying common share, or
$525 per $500 in principal amount of the Series A Debentures, representing
an
aggregate conversion price of $787,500. This redemption right can be exercised
by the Company at any time within ninety (90) days after any date when
the
closing price of the Common Stock has equaled or exceeded $2.00 per share
for a
period of twenty (20) consecutive trading days.
9
As
the
Offering’s placement agent Cantone received a Placement Agent fee of $52,500, or
7% of the gross principal amount of Series A Debentures sold. In addition,
the
Company issued Cantone a four (4) year warrant to purchase 30,450 shares
of the
Company’s common stock at an exercise price of $0.37 per share (the closing
price of the Company’s common shares on the Closing Date) and a four (4) year
warrant to purchase 44,550 shares of the Company’s common stock at an exercise
price of $0.40 per share (the closing price of the Company’s common stock on the
Series A Completion Date), (together the “Placement Agent Warrants”). All
warrants issued to Cantone are immediately exercisable upon issuance.
The
Company has incurred $125,000 in costs related to the offering. Included
in
these costs was $6,000 of non-cash compensation expense related to the
issuance
of the Placement Agent Warrants to Cantone. These costs will be amortized
over
the term of the Series A Debentures. For the three months ended September
30,
2008, the Company amortized $5,000 of expense related to these debt issuance
costs. The Company has also accrued $13,000 in interest expense at September
30,
2008.
Pursuant
to a Registration Rights Agreement, the Company will use reasonable efforts
to
register the Conversion Shares and the shares of Common Stock issuable
upon
exercise of the Placement Agent Warrants.
On
May 8,
2007, the Company purchased a copier through an equipment lease with RICOH
in
the amount of $17,000. The term of the lease is 5 years with an interest
rate of
14.11%. The amount outstanding on this lease was $13,000 and $15,000 at
September 30, 2008 and December 31, 2007, respectively.
Note
E –Sublicense Agreement
On
February 28, 2006, the Company entered into a non-exclusive Sublicense
Agreement
(the “Agreement”) with an unaffiliated third party related to certain patents
allowing us to expand our contract manufacturing operations. Under this
Sublicense Agreement, the Company must pay a non-refundable fee of $175,000
over
the course of 2 years, of which $75,000 was paid in the first quarter of
2006
and $50,000 was paid in the first quarter of 2007. The remaining $50,000
was
paid in the first quarter of 2008. The Company is also required to pay
royalties
for products it manufactures that fall within the scope of these patents.
The
Company was not obligated to pay any royalties in 2006 or 2007. Beginning
with
the year ended December 31, 2007, the Company is obligated to pay a $20,000
minimum annual royalty (“MAR”) that can be applied against royalties on sales of
products that fall within the scope of the sublicensed patents in the fiscal
year ending December 31, 2008. The first MAR payment was made in January
2008
and there were not any sales of products made in the nine months ended
September
30, 2008 that would be applied against the MAR.
Note
F – Integrated Biotechnology Agreement
In
March
2006, the Company entered into a royalty agreement with Integrated Biotechnology
Corporation (“IBC”). IBC is the owner of the RSV (Respiratory Syncytial Virus)
test that the Company manufactures for one of IBC’s distributors. The agreement
was entered into to address amounts that IBC owed to the Company at the
end of
fiscal year 2005, and to streamline the order and fulfillment process of
IBC’s
RSV product. All outstanding amounts due to the Company were satisfied
by the
end of the third quarter of 2007. The Company continues to work directly
with
IBC’s distributor under the terms of the agreement, which states the Company
is
to pay a 20% royalty of total sales to IBC. During the nine months ended
September 30, 2008, IBC earned royalties in the amount of $65,000.
Note
G – Stock Option Grants
In
June
2006, the Company’s Board of Directors granted a stock option to purchase 72,000
shares of the Company’s common stock to the Company’s then Chief Financial
Officer, and an option to purchase 3,000 shares of the Company’s common stock to
an employee in the Company’s R&D division. Both option grants have exercise
prices of $1.05 (the closing price of the Company’s common shares on the date of
grant) and vested 100% on the one-year anniversary of the date of the grant
(although the options granted to the former Chief Financial Officer expired
in
January 2008). In accordance with FAS 123(R), the Company recognized $63,347
in
non-cash compensation expense related to these grants from June 2006 through
May
2007. Included in general and administrative expense for the nine months
ended
September 30, 2007 is $26,000 of this non-cash compensation
expense.
10
Note
H – Employment Agreements
The
Company has entered into employment agreements with its Chief Executive
Officer
Stan Cipkowski, Chief Science Officer Martin R. Gould, Chief Financial
Officer
Stefan Parker and Executive Vice President of Operations Douglas Casterlin,
providing for aggregate annual salaries of $624,000. The
agreement with Chief Executive Officer Cipkowski provides for a $206,000
annual
salary, is for a term of one year and automatically renews unless either
party
gives advance notice of 60 days. The
agreement with the Chief Science Officer Gould provides for a $149,000
annual
salary, is for a term of one year and automatically renews unless either
party
gives advance notice of 60 days. The agreement with Chief Financial Officer
Parker provides for a $120,000 annual salary, is for a term of one year
and
automatically renews unless either party gave advance notice of 60 days.
The
agreement with the Executive Vice President of Operations Casterlin provides
for
a $149,000 annual salary, is for a term of one year and automatically renews
unless either party gives advance notice of 60 days. Copies of Cipkowski
and
Gould’s employment agreements were filed as exhibits to its Quarterly Report
on
Form 10-QSB filed with the Commission on August 13, 2007. A copy of Parker’s
employment agreement was filed as an exhibit to the Company’s Current Report on
Form 8K filed with the Commission on August 24, 2007. A copy of Casterlin’s
employment agreement was filed as an exhibit to the Company’s Current Report on
Form 8-K filed with the Commission on May 1, 2008.
Item
2. Management's Discussion and Analysis of Financial Condition and Results
of
Operations
General
The
following discussion of the Company's financial condition and the results
of
operations should be read in conjunction with the Financial Statements
and Notes
thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This
discussion contains, in addition to historical statements, forward-looking
statements that involve risks and uncertainties. Our actual future results
could
differ significantly from the results discussed in the forward-looking
statements. Factors that could cause or contribute to such differences
include,
but are not limited to, the factors discussed in the section titled "Risk
Factors" in our Annual Report on Form 10-KSB for the year ended December
31,
2007. Any forward-looking statement speaks only as of the date on which
such
statement is made and we do not assume any responsibility to update any
such
forward-looking statement, nor we do intend to update any such forward-looking
statements.
Overview
During
the year ended December 31, 2007, the Company sustained a net loss of $990,000
from net sales of $13,872,000, and had net cash used in operating activities
of
$605,000. During the nine months ended September 30, 2008, the Company
sustained
a net loss of $177,000 from net sales of $10,368,000. The Company had net
cash
used in operating activities of $134,000 for the nine months ended September
30,
2008.
During
the nine months ended September 30, 2008, the Company continued to take
steps to
improve its financial position. Beginning in April 2008, the Company implemented
a number of cost cutting initiatives including, but not limited to, reducing
the
number of employees in its selling and marketing, research and development
and
general and administrative departments. The Company also continues to take
steps
to reduce manufacturing costs related to its products to increase the Company’s
gross margin. Simultaneously with these efforts, the Company continues
to focus
on the development of new products to address market trends and needs.
The
Company's continued existence is dependent upon several factors, including
its
ability to raise revenue levels and reduce costs to generate positive cash
flows, and to sell additional shares of the Company's common stock to fund
operations and/or obtain additional credit facilities, if and when
necessary.
In
July
2008, the Company shipped their first order of its OralStat® oral fluid drug
tests to Save Mart Supermarkets of Modesto, California, a privately held
food
store chain.
In
August
2008, the Company completed its private placement of Series A Debentures.
In
August
2008, the Company was granted CLIA waived status from the US Food and Drug
Administration (“FDA”) of its Rapid TOX® point of collection drug test product
line. The waiver applies to all 14 drugs that the Company’s products currently
test, and to two different cut-off levels for its opiate and cocaine tests.
CLIA
waived tests are recognized by FDA to be so simple to use and so accurate
that
there is little risk of error. CLIA waived tests are the most widely used
tests
in the clinical market (hospitals and physicians), and are in-demand for
occupational health and criminal justice applications.
11
Plan
of Operations
The
Company’s sales strategy continues to be a focus on direct sales, while
identifying new contract manufacturing operations and pursuing new national
accounts. During the nine months ended September 30, 2008, the Company
continued
its program to market and distribute its urine and oral fluid based point
of
collection tests for drugs of abuse and its Rapid Reader® drug screen results
and data management system. Contract manufacturing operations also continued
in
the nine months ended September 30, 2008.
Results
of operations for the nine months ended September 30, 2008 compared to
the nine
months ended September 30, 2007
NET
SALES: Net
sales
for the nine months ended September 30, 2008 were $10,368,000, compared
to
$10,523,000 for the nine months ended September 30, 2007. This represents
a
decrease of 155,000, or 1.5%. When comparing the nine months ended September
30,
2008 with the nine months ended September 30, 2007, international and contract
manufacturing sales increased. These increases were offset by decreases
in
national accounts, outside sales, and in-house sales. Our outside and in-house
sales divisions continue to be affected by price pressures in the criminal
justice market caused by general economic conditions and foreign competition.
Historically, sales in our national account division have increased, but
general
economic conditions have depressed the employment levels of these customers.
Decreases in national account sales in the third quarter of 2008 have thus
negatively impacted the sales results for the nine months ended September
30,
2008. International sales were positively impacted by increased sales to
Latin
America, which were offset by the loss of one of our international distributors
as well as decreased sales to other areas of the world as a result of the
slowing economy.
Our
Rapid
Reader® (drug screen interpretation and data management system), Rapid TOX
(urine based testing cassette), and Rapid TOX Cup® (urine based all inclusive
testing cup) product line sales increased along with an increase in our
Rapid
STAT™ (oral fluid based test device) product line sales. The Rapid TOX Cup and
Rapid STAT product lines were launched late in the third quarter of 2007,
so
there were no sales of these product lines included in the nine months
ended
September 30, 2007. Increases in these product lines were offset by decreases
in
our OralStat® (oral fluid based test device), Rapid TEC® (urine based multi-line
dipstick), RDS InCup® (urine based all inclusive testing cup), and Rapid Drug
Screen product lines. The Company believes that the attrition in these
product
lines is a result of customers switching from one product line to another
due to
either increased ease of use (in the case of the OralStat and Rapid STAT)
or
lower cost (in the case of RDS InCup and Rapid TOX Cup and Rapid TEC and
Rapid
TOX).
In
the
second quarter of 2008, the Company began marketing and selling a new version
of
its Rapid ONE® dipstick product, the Rapid ONE cassette. The Rapid ONE cassette
utilizes the same drug-testing strip as the Rapid ONE, which is inserted
into
the cassette platform used for the Company’s Rapid TOX product line. It is the
Company’s intention to transition the Rapid ONE dipstick product to the Rapid
ONE cassette platform. This product transition will enable the Company
to
assemble and package the device on the Company’s automated production equipment
in its New Jersey facility, thereby making the manufacturing process more
efficient in time and cost, while still providing its customers with the
same
single testing options.
The
Company’s contract manufacturing operations currently include the manufacture of
a HIV test, a test for fetal amniotic membrane rupture, a test for RSV
and other
infectious diseases, and agricultural testing products. The Company was
notified
during the third quarter of 2008 that its agreement with an unaffiliated
third
party to provide drug testing strips for incorporation into the party’s tests
used in hospitals, emergency rooms and clinics will terminate, effective
December 24, 2008. This termination is a result of the party’s merger with
another entity, but the Company is currently negotiating to continue this
contract relationship with the merger successor. The outcome of these
negotiations will not have a material impact on the Company’s current contract
manufacturing operations. Contract manufacturing sales for the nine months
ended
September 30, 2008 totaled $414,000, up from $218,000 for the nine months
ended
September 30, 2007.
COST
OF GOODS: Cost
of
goods sold for the nine months ended September 30, 2008 was $5,822,000,
or 56.2%
of net sales, compared to $6,383,000, or 60.7% of net sales, for the nine
months
ended September 30, 2007. While
the
Company has seen increased costs in raw materials related to the manufacture
of
its products, the Company has been able to improve its cost of goods sold
because of increased manufacturing efficiencies resulting from automation
of its
Rapid TOX product line and a shift in product sales to non-government markets
at
higher gross profit margins. This improvement in cost of goods sold is
also a
result of inventory disposals that occurred during the nine months ended
September 30, 2007 that did not occur during the nine months ended September
30,
2008. The inventory disposals in 2007 consisted of expired products and
components enhanced as a result of product development.
12
OPERATING
EXPENSES: Operating
expenses were $4,615,000, or 44.5% of net sales in the nine months ended
September 30, 2008, compared to $5,003,000, or 47.5% of net sales in the
nine
months ended September 30, 2007. Decreases in costs associated with our
CLIA
waiver application as well as the implementation of cost cutting initiatives
in
research and development, selling and marketing and general and administrative
resulted in expense reductions in all three divisions.
Research
and development (R&D) expense
R&D
expenses for the nine months ended September 30, 2008 were $445,000, or
4.3% of
net sales compared to $520,000, or 4.9% of net sales for the nine months
ended
September 30, 2007. Savings
in consulting fees, supplies and materials, travel, depreciation and telephone
costs were offset by increases in salaries and employee related benefits,
FDA
compliance costs, facility utility costs, and repairs and maintenance.
Effective
June 30, 2008, the Company’s Vice President of Product Development retired.
The
former vice president received a payment of $35,000, equal to half his
annual
salary of $70,000, paid in 3 equal monthly installments of approximately
$11,666
each beginning July 31, 2008, with the last payment being made on September
30,
2008. The Company does not expect to fill this position in the future.
Although
there were increases in salaries and employee related benefits in the nine
months ended September 30, 2008 when compared to the nine months ended
September
30, 2007, the Company expects to see the full savings from this personnel
reduction beginning in the fourth quarter of 2008. In the nine months ended
September 30, 2008, the Company’s R&D department continued to focus its
efforts on development of new products, exploration of contract manufacturing
opportunities and enhancement of its current products.
Selling
and marketing expense
Selling
and marketing expenses in the nine months ended September 30, 2008 were
$2,197,000, or 21.2% of net sales, compared to $2,334,000, or 22.2% of
net
sales, in the nine months ended September 30, 2007. This decrease in expense
results from reductions in sales salaries and commissions, sales employee
related benefits, travel and customer relations, trade show related expenses,
advertising and marketing consulting fees. These decreases were partially
offset
by increases in postage, marketing salaries, and royalty expense as a result
of
increased sales of RSV. The reduction in sales salaries, commissions and
other
employee related benefits resulted from a reduction in sales personnel
as part
of the Company’s implementation of cost cutting initiatives.
General
and administrative (G&A) expense
G&A
expenses were $1,973,000, or 19.0% of net sales in the nine months ended
September 30, 2008 compared to $2,149,000, or 20.4% of net sales in the
nine
months ended September 30, 2007. Expenses in the nine months ended September
30,
2007 included $204,000 of costs associated with the Company’s CLIA waiver
application and $26,000 in non-cash compensation expense. Costs associated
with
the CLIA waiver application significantly decreased to $13,000, and there
was no
non-cash compensation expense in the nine months ended September 30, 2008.
Also
contributing to the decrease in G&A expense were decreases in investor
relations, consulting fees, insurance, travel related expenses, outside
service
fees, and repairs and maintenance. These decreases were partially offset
by
increases in quality assurance related expenses, accounting and legal fees,
patents and licenses, bad debts and bank service fees.
Results
of operations for the three months ended September 30, 2008 compared to
the
three months ended September 30, 2007
NET
SALES:
Net
sales for the quarter ended September 30, 2008 were $3,604,000, compared
to
$3,912,000 for the quarter ended September 30 2007. This represents a decrease
of $308,000, or 7.9%. Decreases in national accounts and outside sales
were
offset by increases in contract manufacturing and international sales.
The
Company’s outside and in-house sales divisions continue to be affected by price
pressures in the criminal justice market caused by general economic conditions
and foreign competition. Historically, sales in our national account division
have increased, but general economic conditions have depressed the employment
levels of these customers, causing the decrease in sales in the third quarter
of
2008. International sales were positively impacted by increased sales to
our
master distributors and customers in Latin America, as well as by increases
in
sales to our European master distributor.
In
the
third quarter of 2008, sales of the Rapid Reader, Rapid TOX, Rapid TOX
Cup and
Rapid STAT product lines increased while sales of the RDS InCup, Rapid
Drug
Screen, OralStat and Rapid TEC product lines decreased. The Rapid TOX Cup
and
Rapid STAT product lines were launched late in the third quarter of 2007,
so
there were no sales of these product lines included in the third quarter
of
2007. Increases in these product lines were offset by decreases in the
OralStat
and RDS InCup product lines. The Company believes that the attrition in
these
product lines is a result of customers switching from one product line
to
another due to either increased ease of use (in the case of the OralStat
and
Rapid STAT) or lower cost (in the case of RDS InCup and Rapid TOX Cup and
Rapid
TEC and Rapid TOX).
13
In
the
second quarter of 2008, the Company began marketing and selling a new version
of
its Rapid ONE® dipstick product, the Rapid ONE cassette. The Rapid ONE cassette
utilizes the same drug-testing strip as the Rapid ONE, which is inserted
into
the cassette platform used for the Company’s Rapid TOX product line. It is the
Company’s intention to transition the Rapid ONE dipstick product to the Rapid
ONE cassette platform. This product transition will enable the Company
to
assemble and package the device on the Company’s automated production equipment
in its New Jersey facility, thereby making the manufacturing process more
efficient in time and cost, while still providing its customer with the
same
single testing options.
The
Company’s contract manufacturing operations currently include the manufacture of
a HIV test, a test for fetal amniotic membrane rupture, a test for RSV
and other
infectious diseases, and agricultural testing products. The Company was
notified
during the third quarter of 2008 that its agreement with an unaffiliated
third
party to provide drug testing strips for incorporation into the party’s tests
used in hospitals, emergency rooms and clinics will terminate, effective
December 24, 2008. This termination is a result of the party’s merger with
another entity, and the Company is currently negotiating to continue this
contract relationship with the merger successor. The outcome of these
negotiations will not have a material impact on the Company’s current contract
manufacturing operations. Contract manufacturing sales for the third quarter
of
2008 totaled $181,000, up from $136,000 for the third quarter of
2008.
COST
OF GOODS:
Cost of
goods sold for the three months ended September 30, 2008 was $2,104,000,
or
58.4% of net sales, compared to $2,493,000, or 63.7% of net sales for the
three
months ended September 30, 2007. While the Company has seen increased costs
in
raw materials related to the manufacture of its products, the Company has
been
able to improve its cost of goods because of increased manufacturing
efficiencies resulting from automation of its Rapid TOX product line and
a shift
in product sales to non-government markets at higher gross profit margins.
OPERATING
EXPENSES:
Operating expenses were $1,373,000, or 38.1% of net sales, in the third
quarter
of 2008, compared to $1,632,000, or 41.7% of net sales, in the third quarter
of
2007. Decreases in costs associated with our CLIA waiver application as
well as
the implementation of cost cutting initiatives in research and development,
selling and marketing and general and administrative resulted in expense
reductions in all three divisions.
Research
and development (R&D) expense
R&D
expenses for the three months ended September 30, 2008 and 2007 were $128,000,
or 3.6% of net sales and $173,000, or 4.4% of net sales, respectively.
Savings
in salaries and employee related benefits, consulting fees, supplies and
materials, telephone and depreciation were partially offset by increases
in
utility costs, FDA compliance costs, and repairs and maintenance. Effective
June
30, 2008, the Company’s Vice President of Product Development, retired. The
former vice president received a payment of $35,000, equal to half his
annual
salary of $70,000, paid in 3 equal monthly installments of approximately
$11,666
each beginning July 31, 2008, with the last payment being made on September
30,
2008. The Company does not expect to fill this position in the future;
therefore, the Company expects to see the full savings from this personnel
reduction beginning in the fourth quarter of 2008. In the third quarter
of 2008,
the Company’s R&D department continued to focus its efforts on development
of new products, exploration of contract manufacturing opportunities and
enhancement of its current products.
Selling
and marketing expense
Selling
and marketing expenses were $713,000, or 19.8% of net sales, in the third
quarter of 2008, compared to $818,000, or 20.9% of net sales, in the same
period
a year ago. This decrease in selling and marketing expense is a result
of
savings in sales salaries and employer related payroll taxes, travel costs,
trade-show related expenses, depreciation, marketing salaries (as a result
in
the reduction in marketing personnel in the third quarter of 2008), and
marketing consulting fees. These savings were partially offset by increases
in
postage, sales employee related benefits and insurance, dues and subscriptions
and royalty expense as a result of increased sales of RSV.
General
and administrative (G&A) expense
G&A
expense were $532,000 or 14.8% of net sales in the three months ended September
30, 2008 compared to $641,000, or 16.4% of net sales in the three months
ended
September 30, 2007. The third quarter of 2007 included $15,000 of costs
associated with our CLIA waiver application; there were no CLIA related
costs in
the third quarter of 2008. Decreases in investor relations, salaries, legal
fees, travel costs, insurances, bank service fees and bad debts, due to
a
recovery of previously written off account, were partially offset by increases
in patents and licenses, auto expense, ISO related expenses, outside service
fees, utilities and contributions.
14
Liquidity
and Capital Resources as of September 30, 2008
The
Company has working capital of $4,658,000 at September 30, 2008 compared
to
working capital of $4,017,000 at December 31, 2007. The Company has historically
satisfied its net working capital requirements through operations, cash
generated by proceeds from private placements of equity securities and
debt
financing. The Company has never paid any dividends on its common shares
and
anticipates that all future earnings, if any, will be retained for use
in the
Company's business and it does not anticipate paying any cash
dividends.
The
Company's cash requirements depend on numerous factors, including product
development activities, sales and marketing efforts, market acceptance
of its
new products, and effective management of inventory levels in response
to sales
forecasts. The Company expects to devote substantial capital resources
to
continue its product development, refine manufacturing efficiencies, and
support
its direct sales efforts. The Company will examine other growth opportunities,
including strategic alliances, and expects such activities will be funded
from
existing cash and cash equivalents, issuance of additional equity or debt
securities or additional borrowings, subject to market conditions. The
Company
believes that its current cash balances, together with cash generated from
future operations, maybe sufficient to fund operations for the next twelve
months, but there can be no assurance of the Company’s continued liquidity. The
Company is required to comply with certain financial covenants under its
Credit
Facilities with FNFG (see Note D), and while the Company is in compliance
with
these financial covenants at September 30, 2008, there can be no assurance
that
such compliance will continue in the future. Non-compliance would constitute
a
default and FNFG may declare all sums outstanding under the Credit Facilities
due and payable without notice or demand. The Company may be required to
sell
additional equity or obtain additional credit facilities. There is no assurance
that such financing will be available or that the Company will be able
to
complete financing on satisfactory terms, if at all.
Despite
implementation of cost cutting initiatives beginning in the second quarter
of
2008, management believes that increases in research and development, selling
and marketing and general and administrative expense may be required in
the
future as the Company continues its investment in long-term growth and
creates
the necessary infrastructure to: achieve its worldwide drug test marketing
and
sales goals, continue its penetration of the direct sales market, support
research and development projects and leverage new product initiatives.
However,
management has taken measures to control the rate of increase of these
costs to
be consistent with the expected sales growth rate of the Company.
Net
cash
used in operating activities was $134,000 for the nine months ended September
30, 2008, compared to $748,000 for the nine months ended September 30,
2007. The
net cash used in operating activities for the nine months ended September
30,
2008 resulted primarily from increases in accounts receivable, inventory
balances and liabilities, including accounts payable, accrued expenses
and wages
payable.
Net
cash
used in investing activities was $48,000 for the nine months ended September
30,
2008, compared to $632,000 for the nine months ended September 30, 2007.
Net
cash used in both years was for investment in property, plant and equipment.
Included in the nine months ended September 30, 2007 was $270,000 representing
the cost of equipment for use in the Company’s New Jersey facility for the
automation of the Company’s Rapid TOX product line.
Net
cash
provided by financing activities was $237,000 for the nine months ended
September 30, 2008, which consisted of proceeds from debenture financing
and the
Company’s line of credit offset by debt issuance costs and payments on the
Company’s outstanding debt and line of credit facilities. Net cash provided by
financing activities for the nine months ended September 30, 2007 was $1,115,000
and consisted of proceeds from a 5-year term note, the Company’s lines of credit
and exercise of stock options offset by debt and line of credit payments.
At
September 30, 2008, the Company had cash and cash equivalents of
$391,000.
The
Company's primary short-term capital and working capital needs relate to
continued support of its research and development programs, focusing sales
efforts on segments of the drugs of abuse testing market that will yield
high
volume sales, refining its manufacturing and production capabilities, and
establishing adequate inventory levels to support expected
sales.
15
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
Not
applicable.
Item
4. Controls and Procedures
(a)
|
Evaluation
of Disclosure Controls and
Procedures
|
Our
Chief
Executive Officer (Principal Executive Officer) and Chief Financial Officer
(Principal Financial Officer), together with other members of management,
have
reviewed and evaluated the effectiveness of our “disclosure controls and
procedures” (as defined in the Securities Exchange Act of 1934 Rule 13a-15(e)
and 15d-15(e)) as of the end of the period covered by this report. Based
on this
review and evaluation, our Principal Executive Officer and Principal Financial
Officer have concluded that our disclosure controls and procedures are
effective
to ensure that material information relating to the Company is recorded,
processed, summarized, and reported in a timely manner.
(b)
Changes in Internal Control Over Financial Reporting
There
have been no changes in the Company's internal control over financial reporting
during the last quarterly period covered by this report that have materially
affected, or are reasonably likely to materially affect, the Company's
internal
control over financial reporting.
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings
See
“Note
C – Litigation” in the Notes to Financial Statements included in this report for
a description of pending legal proceedings in which the Company is a
party.
Item
1A. Risk Factors
Not
applicable.
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
On
August
15, 2008, the Company completed its offering of Series A Debentures and
received
gross proceeds of $750,000. The Series A Debentures accrue interest at
a rate of
10% per annum (payable by the Company semi-annually) and mature on August
1,
2012. The payment of principal and interest on the Series A Debentures
is
subordinate and junior in right of payment to all Senior Obligations, as
defined
under the Series A Debentures. Holders of the Series A Debentures will
have a
right to receive Conversion Shares of Common Stock at a conversion rate
of
666.67 shares per $500 in principal amount of the Series A Debentures
(representing a conversion price of approximately $0.75 per share). This
conversion right can be exercised at any time, commencing the earlier of
(a) one
hundred twenty (120) days after the date of the Series A Debentures, or
(b) the
effective date of a Registration Statement to be filed by the Company with
respect to the Conversion Shares. The Company has the right to redeem any
Series
A Debentures, which have not been surrendered for conversion at a price
equal to
the Series A Debentures’ face value plus $0.05 per underlying common share, or
$525 per $500 in principal amount of the Series A Debentures. This redemption
right can be exercised by the Company at any time within ninety (90) days
after
any date when the closing price of the Common Stock has equaled or exceeded
$2.00 per share for a period of twenty (20) consecutive trading
days.
On
August
15, 2008, the Company completed the Offering and received gross proceeds
of
$750,000 in principal amount of Series A Debentures. The securities issued
in
this transaction were sold pursuant to the exemption from registration
afforded
by Rule 506 under Regulation D as promulgated by the Commission under the
1933
Act, and/or Section 4(2) of the 1933 Act. The Series A Debentures were
placed
with accredited investors, as that term is defined in Rule 501(a) of Regulation
D promulgated by the Commission under the Securities Act of 1933, as amended
(the “ 1933 Act”).
As
the
Offering’s placement agent Cantone received a Placement Agent fee of $52,500, or
7% of the gross principal amount of Series A Debentures sold. In addition,
the
Company issued Cantone a four (4) year warrant to purchase 30,450 shares
of the
Company’s common stock at an exercise price of $0.37 per share (the closing
price of the Company’s common shares on the Closing Date) and a four (4) year
warrant to purchase 44,550 shares of the Company’s common stock at an exercise
price of $0.40 per share (the closing price of the Company’s common stock on the
Series A Completion Date), (together the “Placement Agent
Warrants”).
16
Pursuant
to a Registration Rights Agreement, the Company will use reasonable efforts
to
register the Conversion Shares and the shares of Common Stock issuable
upon
exercise of the Placement Agent Warrants.
Item
3. Defaults upon Senior Securities
None.
Item
4. Submission of Matters to a Vote of Security Holders
None.
Item
5. Other Information
None.
Item
6. Exhibits
31.1
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Executive Officer
|
|
31.2
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Financial Officer
|
|
32.1
|
Certification
of the Chief Executive Officer pursuant to 18 U.S.C. Section
1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
32.2
|
Certification
of the Chief Financial Officer pursuant to 18 U.S.C. Section
1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
17
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant has
caused
this report to be signed on its behalf by the undersigned thereunto duly
authorized.
AMERICAN
BIO MEDICA CORPORATION
|
|
(Registrant)
|
|
By:
/s/ Stefan Parker
|
|
Stefan
Parker
|
|
Chief
Financial Officer
|
|
Executive
Vice President, Finance
|
|
Principal
Accounting Officer and duly authorized
Officer
|
Dated:
November 14, 2008
18