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 March 31, 2010.
OR
¨
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
For the
transition period from ________ to __________
Commission
File Number: 000-50614
ORAGENICS,
INC.
(Exact
name of small business issuer as specified in its charter)
FLORIDA
|
59-3410522
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
13700 Progress
Boulevard
Alachua,
Florida 32615
(Address
of principal executive offices)
(386)
418-4018
(Issuer's
telephone number)
Check
whether the issuer (1) filed all reports required to be filed by Section 13 or
15(d) of the Exchange Act during the past 12 months (or for such shorter period
that the registrant was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days.
Yes x No ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files). 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,”
“non-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 ¨ No x
State the
number of shares outstanding of each of the issuer’s classes of common equity,
as of the latest practicable date:
As of
April 28, 2010, there were 108,083,148 shares of Common Stock, $.001 par
value, outstanding.
|
Page
|
|
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PART
I – FINANCIAL INFORMATION
|
|
|
|
Item
1.
|
Financial
Statements
|
3
|
|
|
|
|
Balance
Sheets as of March 31, 2010 (unaudited) and December 31,
2009
|
3
|
|
|
|
|
Statements
of Operations for the Three months ended March 31, 2010 and 2009
(unaudited)
|
4
|
|
|
|
|
Statements
of Cash Flows for the Three Months ended March 31, 2010 and 2009
(unaudited)
|
5
|
|
|
|
|
Notes
to Financial Statements (unaudited)
|
6
|
|
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
9
|
|
|
|
Item
4T.
|
Controls
and Procedures
|
17
|
|
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PART
II – OTHER INFORMATION
|
|
|
|
Item
1.
|
Legal
Proceedings
|
19
|
|
|
|
Item
1A.
|
Risk
Factors
|
19
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
21
|
|
|
Item
5.
|
Other
Information
|
21
|
|
|
|
Item
6.
|
Exhibits
|
22
|
PART
I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL
STATEMENTS
Oragenics,
Inc.
Balance
Sheets
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
|
(Unaudited)
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
459,125 |
|
|
|
301,592 |
|
Restricted
cash
|
|
|
896,351 |
|
|
|
2,450,000 |
|
Accounts
receivables, net
|
|
|
221,924 |
|
|
|
162,813 |
|
Inventory
|
|
|
278,421 |
|
|
|
132,112 |
|
Prepaid
expenses and other current assets
|
|
|
309,343 |
|
|
|
80,839 |
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
2,165,164 |
|
|
|
3,127,356 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
62,982 |
|
|
|
75,480 |
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
2,228,146 |
|
|
|
3,202,836 |
|
|
|
|
|
|
|
|
|
|
Liabilities
and Shareholders' Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
$ |
573,059 |
|
|
|
478,111 |
|
Short
term note payable
|
|
|
59,578 |
|
|
|
35,012 |
|
Deferred
revenue
|
|
|
8,873 |
|
|
|
50,086 |
|
|
|
|
|
|
|
|
|
|
Total
current liabilities
|
|
|
641,510 |
|
|
|
563,209 |
|
|
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred
stock, no par value; 20,000,000 shares authorized; none issued and
outstanding
|
|
|
- |
|
|
|
- |
|
Common
stock, $0.001 par value; 300,000,000 shares authorized; 108,083,148 and
106,083,149 shares issued and outstanding at March 31, 2010 and December
31, 2009, respectively
|
|
|
108,083 |
|
|
|
106,083 |
|
Additional
paid-in capital
|
|
|
28,737,635 |
|
|
|
28,045,427 |
|
Accumulated
deficit
|
|
|
(27,259,082 |
) |
|
|
(25,511,883 |
) |
|
|
|
|
|
|
|
|
|
Total
shareholders' equity
|
|
|
1,586,636 |
|
|
|
2,639,627 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and shareholders' equity
|
|
$ |
2,228,146 |
|
|
|
3,202,836 |
|
See
accompanying notes.
Oragenics,
Inc.
Statements
of Operations
(Unaudited)
|
|
Three months ended
|
|
|
|
March 31
|
|
|
|
2010
|
|
|
2009
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
341,483 |
|
|
|
124,272 |
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
|
198,901 |
|
|
|
11,780 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
444,368 |
|
|
|
585,664 |
|
Selling,
general and administrative
|
|
|
1,446,629 |
|
|
|
1,507,155 |
|
|
|
|
|
|
|
|
|
|
Total
operating expenses
|
|
|
1,890,997 |
|
|
|
2,092,819 |
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(1,748,415 |
) |
|
|
(1,980,327 |
) |
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,889 |
|
|
|
522 |
|
Interest
expense
|
|
|
- |
|
|
|
(545 |
) |
Gain
on sale of property and equipment
|
|
|
- |
|
|
|
- |
|
Local
business tax
|
|
|
(673 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total
other income (expense), net
|
|
|
1,216 |
|
|
|
(23 |
) |
|
|
|
|
|
|
|
|
|
Loss
before income taxes
|
|
|
(1,747,199 |
) |
|
|
(1,980,350 |
) |
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,747,199 |
) |
|
|
(1,980,350 |
) |
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per share
|
|
$ |
(0.016 |
) |
|
|
(0.056 |
) |
|
|
|
|
|
|
|
|
|
Shares
used to compute basic and diluted net loss per share
|
|
|
107,805,370 |
|
|
|
35,069,261 |
|
See
accompanying notes.
Oragenics,
Inc.
Statements
of Cash Flows
(Unaudited)
|
|
Three months ended
|
|
|
|
March 31
|
|
|
|
2010
|
|
|
2009
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,747,199 |
) |
|
|
(1,980,350 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
18,696 |
|
|
|
65,379 |
|
Stock-based
compensation expense
|
|
|
194,208 |
|
|
|
18,944 |
|
Gain
on sale of property and equipment
|
|
|
- |
|
|
|
- |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable, net
|
|
|
(59,111 |
) |
|
|
(1,096 |
) |
Inventory
|
|
|
(146,309 |
) |
|
|
(53,029 |
) |
Prepaid
expenses and other current assets
|
|
|
(228,504 |
) |
|
|
(15,421 |
) |
Accounts
payable and accrued expenses
|
|
|
94,948 |
|
|
|
839,624 |
|
Deferred
revenue
|
|
|
(41,213 |
) |
|
|
|
|
Deferred
compensation
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(1,914,484 |
) |
|
|
(1,125,949 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchase
of property and equipment, net
|
|
|
(6,198 |
) |
|
|
(9,074 |
) |
|
|
|
|
|
|
|
|
|
Net
cash used in investing activities
|
|
|
(6,198 |
) |
|
|
(9,074 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
Borrowings
under short term note payable
|
|
|
50,637 |
|
|
|
53,087 |
|
Payments
on short term note payable
|
|
|
(26,071 |
) |
|
|
(26,074 |
) |
Net
proceeds from issuance of common stock
|
|
|
500,000 |
|
|
|
- |
|
Restricted
cash released from common stock proceeds
|
|
|
1,553,649 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
2,078,215 |
|
|
|
27,013 |
|
|
|
|
|
|
|
|
|
|
Net
increase (decrease) in cash and cash equivalents
|
|
|
157,533 |
|
|
|
(1,108,010 |
) |
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at beginning of the period
|
|
|
301,592 |
|
|
|
1,165,933 |
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at end of the period
|
|
$ |
459,125 |
|
|
|
57,923 |
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
paid
|
|
$ |
18,377 |
|
|
|
545 |
|
See
accompanying notes.
Oragenics,
Inc.
Notes
to Financial Statements
(Unaudited)
1. Organization
and Significant Accounting Policies
Oragenics,
Inc. (the “Company”) was incorporated in November 1996; however, operating
activity did not commence until 1999. The Company is dedicated to developing
technologies associated with oral health, broad spectrum antibiotics and general
health benefits.
Basis of
Presentation
The
accompanying unaudited condensed financial statements as of March 31, 2010 and
December 31, 2009 and for the three months ended March 31, 2010 and
2009 have been prepared in accordance with accounting principles generally
accepted in the United States of America (GAAP) for interim financial
information and with the instructions to Form 10-Q and Article 10 of Regulation
S-X. Accordingly, they do not include all of the information and footnotes
required by GAAP for complete financial statements. In the opinion of
management, the accompanying financial statements include all adjustments,
consisting of normal recurring accruals, necessary for a fair presentation of
the financial condition, results of operations and cash flows for the periods
presented. The results of operations for the interim period March 31, 2010 are
not necessarily indicative of the results that may be expected for the year
ended December 31, 2010 or any future period.
These
financial statements should be read in conjunction with the audited financial
statements and notes thereto for the year ended December 31, 2009, which are
included in our Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 31, 2010. In that report the Company
disclosed that it expects to incur substantial expenditures to further develop
each of its technologies and that it believes its working capital will be
insufficient to meet the business objectives as presently structured and that
without sufficient capital to fund its operations, the Company will be unable to
continue as a going concern. The accompanying financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
Although the Company currently believes that it will have sufficient resources
to commercialize selective products, it intends to seek additional funding to
further develop and commercialize other products.
Adoption
of New Accounting Standards
In August
2009, the FASB issued ASU 2009-05, “Fair Value Measurements and Disclosures (ASC
Topic 820) — Measuring Liabilities at Fair Value” (“Update 2009-05”).
Update 2009-05 provides clarification regarding valuation techniques when a
quoted price in an active market for an identical liability is not available in
addition to treatment of the existence of restrictions that prevent the transfer
of a liability. Update 2009-05 also clarifies that both a quoted price in an
active market for an identical liability at the measurement date and the quoted
price for an identical liability when traded as an asset in an active market
(when no adjustments to the quoted price of the asset are required) are
Level 1 fair value measurements. This standard is effective for the first
reporting period, including interim periods, beginning after issuance. Adoption
of Update 2009-05 did not have a material effect on Company’s financial
statements.
On
July 1, 2009 the Financial Accounting Standards Board (“FASB”) Accounting
Standards Codificationtm
(“ASC”) became the authoritative source of accounting principles to be applied
to financial statements prepared in accordance with U.S. Generally Accepted
Accounting Principles (“GAAP”). In accordance with the ASC, citations to
accounting literature in this report are to the relevant topic of the ASC or are
presented in plain English. This standard is effective for financial statements
issued for interim and annual periods ending after September 15, 2009. The
Company adopted this standard at its effective date.
Revenue
Recognition
The
Company recognizes revenue from the sales of product when title and risk of loss
pass to the customer, which is generally when the product is shipped. Grant
revenues are recognized as the reimbursable expenses are incurred over the life
of the related grant. Grant revenues are deferred when reimbursable
expenses have not been incurred.
The
Company records allowances for discounts and product returns at the time of
sales as a reduction of revenue as such allowances can be reasonably estimated
based on historical experience or known trends. Product returns are
limited to specific mass retail customers for expiration of shelf life or unsold
product over a period of time.
Inventory
Inventories
are stated at the lower of cost or market. Cost, which includes
material, labor and overhead, is determined on a first-in, first-out
basis. In March, we recorded $73,490 of consignment inventory with a
mass retailer and will be reduced as shipments are made.
2. Net
Loss Per Share
During
all periods presented, the Company had securities outstanding that could
potentially dilute basic earnings per share in the future, but were excluded
from the computation of diluted net loss per share, as their effect would have
been antidilutive. Because the Company reported a net loss for all periods
presented, shares associated with the stock options and warrants are not
included because they are antidilutive. Basic and diluted net loss per share
amounts are the same for the periods presented. Net loss per share is computed
using the weighted average number of shares of common stock
outstanding.
3. Income
Taxes
Income
taxes are accounted for under the asset and liability method. Deferred tax
assets and liabilities are recognized for future tax consequences attributable
to differences between the financial statement carrying amounts of existing
assets and liabilities and their respective tax bases and operating loss and tax
credit carryforwards.
Deferred
tax assets and liabilities are measured using enacted tax rates expected to
apply to taxable income in the years in which those temporary differences are
expected to be recovered or settled. The effect on deferred tax assets and
liabilities of a change in tax rate is recognized in operations
in the period that includes the enactment date. Deferred tax assets are reduced
to estimated amounts expected to be realized by the use of a valuation
allowance.
In July
2006, the FASB issued guidance which clarifies accounting for uncertainty in
income taxes recognized in an entity’s financial statements in accordance with
GAAP and prescribes a recognition threshold and measurement attributes for
financial statement disclosure of tax positions taken or expected to be taken on
a tax return. Under GAAP, the impact of an uncertain income tax
position on the income tax return must be recognized at the largest amount that
is more-likely-than-not to be sustained upon audit by the relevant taxing
authority. An uncertain income tax position will not be recognized if
it has less than a 50% likelihood of being sustained. Additionally,
GAAP provides guidance on derecognition, classification, interest and penalties,
accounting for interim periods, disclosure and transition.
The
Company files its income tax returns in the U.S. federal jurisdiction and in
Florida. With few exceptions, the Company is no longer subject to federal or
state income tax examinations by tax authorities for years before
2006.
4. Fair
Value of Financial Instruments
ASC 820,
Fair Value Measurements and
Disclosures, defines fair value,
provides guidance for measuring fair value and requires certain disclosures.
This standard discusses valuation techniques, such as the market approach
(comparable market prices), the income approach (present value of future income
or cash flow), and the cost approach (cost to replace the service capacity of an
asset or replacement cost). The standard utilizes a fair value hierarchy that
prioritizes the inputs to valuation techniques used to measure fair value into
three broad levels. The following is a brief description of those three
levels:
Level 1. Observable inputs
such as quoted prices in active markets;
Level 2. Inputs, other than
the quoted prices in active markets, that are observable either directly or
indirectly; and
Level 3. Unobservable inputs
in which there is little or no market data, which require the reporting entity
to develop its own assumptions.
The
Company does not have any assets or liabilities measured at fair value on a
recurring basis at March 31, 2010. The Company did not have any fair value
adjustments for assets and liabilities measured at fair value on a nonrecurring
basis during the three months ended March 31, 2010.
5. Stock
Options Expense During the 1st Quarter, 2010
During
the 1st quarter, the Company did not issue any stock options and there were no
forfeitures recorded. From January 1, 2009 to the date of this filing, no
stock options previously granted have vested or have been forfeited. Stock
option compensation expense of $194,208 was recorded and is a non-cash
expense. This amount is included in research and development and
selling, general and administrative expenses in the accompanying statement
of operations.
6. Common
Stock Issued During the 1st Quarter, 2010
In
January 2010, we completed the closing of a $3.0 million private placement of
common stock pursuant to a Common Stock Purchase Agreement with accredited
investors. The Company issued an additional 2,000,000 shares of its Common Stock
at a price of $0.25 per share to the investors for $500,000, the payment of
which consisted of $500,000 in cash at closing. Half of the total
investment, or $250,000, was made by the Koski Family Limited
Partnership.
7.
Short Term Notes Payable
In March, we entered into a short term
note payable for $50,637 with an interest rate of 5.75% to finance our
product liability insurance. This note matures January 10,
2011. At March 31, 2010 the balance due was $45,573.
On August
6, 2009 the Company entered into a short term note payable for $70,025 with an
interest rate of 5.75% to finance directors and officers liability
insurance. This note matures on May 24, 2010. At March 31,
2010 the balance due was $14,005.
8. Outstanding
Warrants and Stock Options
As of the
date of this filing there are approximately 6,127,778 warrants outstanding and
there are approximately 7,719,300 outstanding stock options that have been
granted that have not been forfeited. The total number of outstanding
warrants and unexercised stock options is 13,847,078. If all warrants
and stock options were exercised, the total number of outstanding shares would
be approximately 121,930,226.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The
following information should be read in conjunction with the Financial
Statements, including the notes thereto, included elsewhere in this Form 10-Q.
This discussion contains certain forward-looking statements that involve risks
and uncertainties. Our actual results and the timing of certain events could
differ materially from those discussed in these forward-looking statements as a
result of certain factors, including, but not limited to, those set forth herein
and elsewhere in this Form 10-Q.
Overview
We are a
multi-faceted biopharmaceutical company focused on the discovery,
development and commercialization of a variety of products and
technologies. Our offices are located in Tampa, Florida and Alachua,
Florida. The office in Alachua, Florida is near the University of
Florida where we have our experienced scientific team in place in which to lead
us into an exciting new phase of operations. In 2009, we
transitioned from a company with a historic focus exclusively on research and
development to a company with increased focus on immediate and long term
commercialization and monetization. We possess a number of
proprietary products and technologies some of which we have begun to
commercialize. We believe that each of our products and
platform technologies addresses potentially large market
opportunities.
We
generate revenue through the sale of our consumer healthcare products and
sponsored research agreements and government grants. We are
optimistic about the ongoing level of interest we are experiencing with our
lead branded consumer healthcare products at this time. As our Probiora3
and EvoraPlus manufacturing, marketing and selling initiatives progress, we
expect to continue to experience a higher level of overall
expenses associated with such efforts as well as with the continued
development of our technologies. We expect the current increases in our
expenses to continue into the near future as we fully implement the
initiatives we have underway.
We had a
net loss of $1,747,199 for the three months ended March 31, 2010 and we
currently do not have sufficient capital to fund our operations beyond June
2010. We are continuing our efforts to seek additional
capital. If we are unable to obtain additional capital to fund our
operations we will need to take steps to substantially limit or reduce our
operations until we are able to do so. Such steps, if implemented,
could have an adverse effect on the progress of our commercialization and
continued development efforts. Our goal has been and continues to be
that we achieve positive operational cash flow as quickly as possible by
allocating most of our resources on the commercialization or monetization of
technologies that can provide revenues in the near term. This means
that our priority is to focus the bulk of our resources on the Consumer
Healthcare Division. While our progress toward positive operational
cash flow has been slower than we had initially anticipated, we remain optimistic
about the prospects in the future given the foundation we have established in
getting our Consumer Healthcare Products on the shelves of large
retailers. We also expect to seek opportunities in Biomarker
Discovery that either provide up-front money or fee-for-service
arrangements. While we are pursuing these priorities, we expect to
simultaneously make incremental progress in Antibiotics, Biomarker Discovery and
Biologics, as capital resources permit, until they reach an inflexion
point and can be monetized. The pace of any incremental progress we
may achieve, however, will be based on the amount of our limited available
capital resources we are able to allocate to each individual
technology. If we are able to obtain sufficient additional capital,
the pace of progress would be expected to increase. Once we begin to monetize
our current technologies, we will also be able to commit greater capital to
further research and development alternative technologies that are in alignment
with our vision and strategic goals.
Financial
Strategy
Since our
inception, we have funded a significant portion of our operations from the
public and private sales of our securities. Furthermore, we have not earned
significant revenue from operations. Until recently most of our
revenue has been from sponsored research agreements and various governmental
grants. We require additional capital to fund our business operations and we
continue to seek additional capital to effectuate our business
plans. There can be no assurances that such additional capital will
be available to us or on favorable terms or at all. The further development,
testing and commercialization of our technologies, individually and in the
aggregate, are expected to be costly to undertake and complete and will require
additional capital over and above what we currently have available to us. Our
current available capital limits our ability to fully develop our technologies.
We expect to allocate our limited capital resources to the development of our
technologies while we continue to explore additional capital raising
opportunities. The time periods for the expected continued development of our
technologies have been extended from those previously indicated by us from time
to time due primarily to our insufficient capital position. The time
periods for expected developments could also change in the future depending on
the progress of our ability to negotiate a partnering arrangement, as well as
our efforts to raise additional capital and generate revenue .
We have
started to generate revenue from the sales of our Consumer Healthcare Products
and technologies and our revenue in the three months ended March 31, 2010 was
$341,483 as compared to $124,272 in the three months ended March 31,
2009. Our objective is that the revenue from Consumer Healthcare
products will be able to fully and sufficiently support the continued operations
of the Consumer Healthcare Products Division. We anticipate
additional purchase orders and/or revenue from the sale of EvoraPlus TM , our oral probiotic for
adults, and from Teddy’s Pride
TM , our oral probiotic for the companion pet market. We also
anticipate that, we will have opportunities to partner with or license some of
our technologies to larger global companies. We hope to be able to
negotiate upfront payments in connection with these potential partnerships
and/or licenses.
Operational
Strategy
We have a
number of products and platforms. These products and platforms are structured
and viewed by us as four distinct Divisions:
(1)
Consumer Healthcare, which consists of ProBiora3TM, the EvoraPlusTM, Teddy’s PrideTM and EvoraKidsTM as well as the LPT3-04 TM weight loss
agent;
(2)
Biomarker Discovery (formerly referred to by us as “Diagnostics”), which
consists of the PIVIATTM
and PCMAT
TM platforms;
(3)
Antibiotics, which consists of our lead antibiotic, MU 1140, and the DPOLTTM lantibiotic synthesis
platform; and
(4)
Biologics (formerly referred to by us as “Replacement Therapy”), which consists
of our SMaRTTM Bacterial
Replacement Therapy technology.
Because
we have limited capital and human resources, we cannot pursue commercialization
and further development of each and every technology that we own
simultaneously. As such, we have decided to pursue a strategic course
that focuses the majority of our resources towards those technologies that
present the best opportunity to generate revenue for the Company in the
short-term. The allocation of resources is determined by us on a
case-by-case basis and is subject to periodic review. Currently, we
are rolling out products in our Consumer Healthcare Division and most of our
resources are being deployed in support of that endeavor. However, we
expect to continue to commit any remaining available resources to our other
three divisions. As the Consumer Healthcare Division matures and
begins to generate meaningful revenue and is able to become self-sustaining, we
anticipate being able to allocate greater resources to the other
divisions. We have a contractual obligation to pay a minimum royalty
of $25,000 per quarter and spend or cause to be spent an aggregate of $1,000,000
per annum toward research, development and regulatory prosecution, in order to
maintain our license with the University of Florida Research Foundation, Inc.
for our SMaRT Replacement Therapy™ and MU 1140™ technologies. We
believe we have met the $1,000,000 per annum threshold for research, development
and regulatory prosecution in 2009 and made the minimum quarterly royalty
payments for 2009. Royalty payments for the first quarter of
2010 are expected to be made during the second quarter. If we
are unable to make the minimum royalty payments in the future, our license could
be terminated which will substantially diminish the value of our
company.
Highlights
and Recent Developments
Company
highlights and recent developments are set forth below in the following
categories; Operational, Financial and Corporate and Management.
Operational:
We
believe we have made important strides operationally in the second half of 2009
and in early 2010. Most notably, we recently gained significant
traction in the domestic mass retail distribution channel for our consumer
healthcare products as evidenced by the following announcements:
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Rite Aid: On
May 3, 2010, we announced that Rite Aid, one of the country’s leading drug
store chains, will offer EvoraPlus TM. Starting
in May 2010, EvoraPlus
TM would be available in nearly 4,800 Rite Aid stores
nationwide.
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RicciPharma: On April
12, 2010, we announced that RicciPharma, a recognized health products
company with offices in Rome and Slovakia, have entered into a
distribution agreement that the parties anticipate will provide Oragenics
proprietary oral care probiotic products, EvoraPlus TM and EvoraKids TM, to
RicciPharma.
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Celgen: On March 25,
2010, a distribution agreement was signed with Celgen Nutritional Company,
LTD of Taiwan. Celgen is a market leader in offering nutritional
ingredients with scientific based natural solutions to benefit human
healthcare and wellness in the greater China area. They have
exclusive rights to market EvoraPlus TM to the dental market
throughout Taiwan.
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Walgreens: On
February 8, 2010, we announced that Walgreens, the country’s largest drug
store chain, will offer EvoraPlusTM
chain-wide beginning March 19, 2010 and that EvoraPlusTM would
now be available both at all of Walgreens more than 7,000 locations as
well as its popular online
destination.
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A&P Supermarkets and
Pathmark: On December 15, 2009, we announced the mass
retail launch of EvoraPlus and Teddy’s Pride in A&P Supermarkets and
Pathmark, which together account for nearly 1,000 locations across the
country.
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Hannaford and Sweet Bay
Supermarkets: On December 15, 2009, we also announced
that EvoraPlus will be carried in early January by Hannaford Supermarkets’
pharmacies covering Maine, Massachusetts, New Hampshire, New York and
Vermont and Sweet Bay Supermarkets covering
Florida.
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Chiropractors Buying
Group: On January 26, 2010, we announced that we have
signed a distribution agreement with Chiropractors Buying Group (CBG) to
represent our probiotic oral care mint EvoraPlus to chiropractic offices
nationwide.
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EvoraKids
Launch: On January 25, 2010, we announced the launch of
EvoraKids, which has been specifically formulated for children 3-10 years
old to help maintain healthy teeth. EvoraKids features a tasty
Wild Very Cherry Berry flavored
chew.
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Wolverton Garden and Pet
Supplies: On January 7, 2010, we announced that we had
named Wolverton Garden and Pet Supplies as a regional distributor for
Teddy’s Pride™, the first-ever all-natural probiotics breath freshener and
teeth whitener created especially for dogs and
cats. Established in 1940 in Lansing, Michigan, Wolverton
Garden and Pet Supplies today ranks among the industry’s largest and most
distinguished pet supply distributors with more than 14,000 items from
over 300 suppliers for all categories of pets. Wolverton’s customer base
comprises kennels, veterinarian clinics, independent pet stores, and large
chain and mass accounts.
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Garden of Life: On
February 4, 2009, we announced that Garden of Life has been awarded rights
to use our oral-care probiotic ingredient, ProBiora3. This agreement gives
Garden of Life exclusive rights to use ProBiora3 in the natural products
market. ProBiora3 is a patent-pending probiotic formula containing a blend
of three bacteria that work below the gum line to address oral health at
its root cause.
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In
addition to the above announcements, the Company’s oral-care product lines have
been the subject of numerous feature stories and positive reviews in magazines,
newspapers and websites nationwide, along with television
segments. Some of this media coverage is listed
below:
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FOX Television: The
Company and its core products have been featured several times on FOX
television newscasts nationally.
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National Medical Report with
Hugh Downs:
The Company has been featured on the National Medical Report hosted by
Hugh Downs.
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The Balancing Act:
Oragenics and its product line were featured on The Balancing Act, an
award-winning talk and magazine show reaching 96 million homes that airs
weekday mornings on Lifetime Channel on January 18, 2010, February 8, 2010
and March 8, 2010 .
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Newspapers and Blogs:
More than 800 newspapers have discussed EvoraPlus in their editorial
section and hundreds of health-oriented websites and grassroots ‘blogs’
have prominently featured both EvoraPlus and Teddy’s Pride with unanimous
positive reviews and ‘recommendations to
purchase’.
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We
believe these events provide a solid foundation from which to build and expand
upon the marketing and distribution of our Consumer Healthcare Products in future
periods.
Financial:
During
2009, we completed two private placement transactions with accredited
investors. In June 2009, we consummated a private placement with the
Koski Family Limited Partnership (“KFLP”) which resulted in the KFLP acquiring a
controlling interest in our Company (the “June 2009 Private
Placement”). With the proceeds from the June 2009 Private Placement,
we were able to continue to initiate our transition efforts toward
commercialization of our consumer healthcare products as well as continue the
development of our other technologies. In addition, and in
furtherance of its commitment to us, the KFLP also participated in the initial
closing of a private placement along with other accredited investors in December
2009 (the “December 2009 Private Placement”). The December 2009
Private Placement provided us with additional necessary capital and resulted in
the exchange of equity for secured debt that was outstanding to the KFLP in
connection with the earlier June 2009 Private Placement. For further
information on the details of the June 2009 Private Placement and the December
2009 Private Placement see “
Management’s Discussion and Analysis of Final Condition and Results and
Operations — Liquidity
and Capital Resources. ”
On
January 13, 2010, we completed the $3,004,062 private placement
contemplated by the Securities Purchase Agreement and December 2009 Private
Placement and issued another 2,000,000 shares of common stock at a price of
$0.25 per share to the accredited investors for $500,000. Of this
amount the KFLP again participated in one half of the remainder of the aggregate
investment by acquiring 1,000,000 shares for $250,000.
Corporate
and Management:
At our
annual meeting of shareholders, held on October 28, 2009, our shareholders
approved a Second Amendment to our
Amended and Restated 2002 Stock Option and Incentive Plan (the "Plan") to
increase the available shares from 5,000,000 to 12,500,000 shares with all other
terms of the Plan remaining the same. In addition the shareholders
also approved an amendment to our
Articles of Incorporation to increase our authorized common shares from 100
million (100,000,000) shares to 300 million (300,000,000). All other provisions
of the Articles of Incorporation remained in full force and effect. The Amended
Articles of Incorporation have been filed with the Secretary of State of
Florida. With
these changes to our articles we were able to proceed with the December 2009
Private Placement and will have the availability of additional authorized shares
to be able to continue to seek additional capital on a go forward
basis.
In
addition, on January 20, 2010, we announced that we had engaged government
relations firm GSP Consulting ("GSP") to represent the Company for the purpose
of securing government funding for a number of its technologies. GSP will focus
on partnering with government and NGO healthcare organizations to increase the
speed to market for Antibiotics, Biomarker Discovery and our Biologic, SMaRT
Replacement Therapy.
During
the course of 2009, we also experienced changes in our directors and senior
management. As a result of the June 2009 Private Placement, Christine
Koski, Robert Koski and David Hirsch were appointed to our Board of Directors
with Christine Koski elected as Chairperson. Three of our then
existing directors resigned upon the consummation of the
transaction. Our acting President and Chief Executive Officer, David
Hirsch, was also appointed President and Chief Executive Officer and Brian
Bohunicky was appointed as our Chief Financial Officer.
Business
Objectives and Milestones
In each
of our divisions we have designated business objectives as follows:
Consumer
Healthcare
Our
Consumer Healthcare Division has been tasked with the commercialization of our
oral probiotics, which revolve around the ProBiora3 technology, and the further
development and commercialization of our weight loss agent,
LPT3-04.
Oral Probiotics: We
have established two primary goals regarding the development of our oral
probiotics business: (1) for the consumer healthcare division to become
operationally cash flow positive by the end of 2010, and (2) to maximize the
combined sale of our consumer healthcare products in the markets
served.
Weight Loss: We are
currently in the process of re-formulating the delivery mechanism of LPT3-04
such that it provides an enhanced consumer experience. Once this is
finished, we will conduct a clinical trial to fully establish
efficacy. After the clinical trial has been completed and efficacy is
established, we will then begin marketing our first product in the weight loss
category. Our goal is to begin to market a product containing
LPT3-04 in the first quarter of 2011.
Antibiotics
We are
currently scaling production of Synthetic MU 1140 with Almac Sciences, a
top-tier European peptide manufacturer. Once this process has been
completed, we then plan on conducting pre-clinical testing. If
pre-clinical testing is positively concluded, we will file an IND with the FDA,
which will include a protocol for Phase I clinical safety trials. Our
goal is to complete the scale up and complete pre-clinical testing by the end of
2010 and begin Phase I clinical safety trials in the first half of
2011. We have also started efforts to seek partnerships or licensing
arrangements with large pharmaceutical companies for both MU 1140 and the DPOLT
Platform; however, we anticipate that we will be unable to procure such
arrangements until we have completed either a pivotal pre-clinical animal trial
or Phase I clinical trials for MU 1140, our lead antibiotic.
Biomarker
Discovery
The goal
of our Diagnostics unit is to utilize the PIVIATTM and PCMATTM platforms to identify and
secure intellectual property rights to gene targets associated with the natural
onset and progression of infections, cancers and other diseases in humans,
animals, and agricultural products. We believe these platforms provide a number
of profitable business models from which to realize value. We believe
that our new fluidics based approach will provide us substantial advantages once
it has been fully proven. If this occurs, our goal will be to
complete three to five studies on high-value disease states by the end of
2010.
Biologics
Our
Biologics Division is centered on SMaRT Replacement TherapyTM, our product for dental
caries (tooth decay). SMaRT Replacement Therapy TM can potentially
provide substantial back-end savings to countries since the long-term costs
associated with dental caries are substantial. We have been approved
by the FDA for a Phase I(b) clinical trial. As such, we are also
investigating the possibility of beginning the Phase I(b) clinical trial in the
United States in the immediate future. Popular Mechanics cited our
patented SMaRT Replacement Therapy tooth decay-fighting bacterial strain #1
among its "20 New Biotech Breakthroughs That Will Change Medicine" published in
the monthly magazine's March 2009 issue.
Global
Expansion
Although
we are domiciled in the United States, we believe there are opportunities and
advantages in utilizing foreign talent and markets for a variety of our products
and technologies. We have embarked upon global strategic initiatives, we
are currently reviewing and evaluating our global strategic
plans given our limited capital resources and the costs associated
with such efforts and the expected benefits.
Critical
Accounting Estimates
Our
discussion and analysis of our financial condition and results of operations are
based upon our financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States of America. The
preparation of financial statements in accordance with accounting principles
generally accepted in the United States of America requires us to make estimates
and assumptions that affect reported amounts and related disclosures. We
consider an accounting estimate to be critical if it requires assumptions to be
made that were uncertain at the time the estimate was made; and changes in the
estimate or different estimates that could have been made could have a material
impact on our results of operations or financial condition. Our financial
statements do not include any significant estimates other than stock based
compensation that would have a material impact on our results of operations or
financial condition.
New
Accounting Pronouncements
Results
of Operations
Three
Months Ended March 31, 2010 and 2009
We had
$341,483 in revenues in the three months ended March 31, 2010 compared with
$124,272 of revenues in the same period in 2009. Revenue increased due to
product sales of EvoraPlus by $222,725 and Teddy’s Pride by $52,572. Grant
revenues decreased by $58,086 due to completion of the Small Business Innovation
Research (SBIR) grant for DPOLT in 2009 which was offset by the University of
Florida grant to identify disease-specific proteins expressed during citrus
greening using our proprietary PCMAT in the amount of $41,914.
Cost of
sales of $198,901 were recorded in the three months ended March 31, 2010
compared with $11,780 in cost of sales in the same period in
2009. These costs include the production and manufacture of our
Consumer Healthcare products totaling $86,979. Cost of sales also includes
shipping and processing expenses of $30,420. Cost of sales also includes scrap
expense of $81,502 which represents product rework charges and the replacement
of inventory with our new improved EvoraPlus product.
Our first
quarter operating expenses consist of Research and Development (R&D)
expenses and Selling, General and Administrative (SG&A)
expenses. R & D expenses consist primarily of salaries/benefits,
patent fees, and research expenses. SG&A expenses consist
primarily of salaries/benefits, marketing costs, and legal fees. Our
operating expenses decreased by 9.6% to $1,890,997 in the three months ended
March 31, 2010 from $2,092,819 in the same period in 2009. R&D
expenses decreased 24.1% to $444,368 in the three months ended March 31, 2010
from $585,664 in the same period in 2009. Even though total R&D
expenses declined, stock options expense increased by $57,649 as a result of the
2009 option grants. Compared to the same period in 2009, R&D
expenses reflect reductions in salaries and fringe costs as a result of the
decrease in staff by $50,136, reduced consulting fees by $65,124, lower royalty
expenses by $18,780, lower repairs/maintenance of $16,662, drop in depreciation
expense of $44,386 due to fully depreciated lab equipment, and reductions in
legal patent expenses of $12,430. SG&A expenses decreased by 4.0%
to $1,446,629 in the three months ended March 31, 2010 from $1,507,155 in the
same period in 2009. Even though total SG&A expenses declined, stock options
expense increased by $117,615, advertising expenses increased by $207,487, and
salaries and fringe costs increased $84,487 as a result of additional
staff. The decrease over the prior period was primarily due to
reduced travel expenses of $115,815, reduced consulting fees of $74,370, reduced
legal fees of $203,761 and accounting fees of $86,298.
Other
income for the three months ended March 31, 2010 of $1,216 includes
interest income totaling $1,889 offset by local taxes of
$673. Compared to the same period in 2009, other income is $1,239
higher due to interest income and no interest expense. The lower
interest income recorded during both periods is primarily due to the low money
market interest rates available. These lower interest rates are
expected to continue for the foreseeable future.
We
incurred net losses of $1,747,199 and $1,980,350 during the three months ended
March 31, 2010 and 2009, respectively. The decrease in our net loss was
principally caused by the reduction in R&D expenses and legal
fees..
Liquidity
and Capital Resources
Since our
inception, we have funded our operations primarily through the sale of equity
securities in private placement and our initial public offering, the sale of
equity securities and warrants in private placements, debt financing and
grants.
Our
operating activities used cash of $1,914,484 for the three months ended March
31, 2010 and $1,125,949 for the three months ended March 31, 2009. We
had positive working capital of $1,523,654 as of March 31, 2010 compared to a
positive working capital of $2,564,147 as of December 31, 2009. Cash used by
operations in the three months ended March 31, 2010 resulted primarily from our
net loss from operations of $1,747,200.
Our
investing activities used cash of $6,198 for the three months ended
March 31, 2010 as compared to used cash of $9,074 for the same period ending
March 31, 2009.
Our
financing activities for the three months ended March 31, 2010 provided net cash
increase of $2,078,215 as compared to a net cash increase of $27,013 for the
three months ended March 31, 2009. This increase was primarily
attributable to the release of restrictions on cash and the sale of our common
stock to accredited investors through our private placement transaction
initiated in December 2009 and completed in early January 2010. Additional
details of our financing activities are provided below:
June
2009 Private Placement
On June
29, 2009, we successfully entered into and consummated a private placement of
equity and debt financing pursuant to a securities purchase agreement (the
“Purchase Agreement”) with an accredited investor. Pursuant to the
terms of the Purchase Agreement the Company issued 50,000,000 shares of its
Common Stock to the Koski Family Limited Partnership (“KFLP”) and issued
warrants to the KFLP to acquire 1,000,000 shares of Company common stock at an
exercise price of $0.10 per share in exchange for $4,000,000, the payment of
which consisted of the following: $1,500,000 in cash at closing and $2,500,000
pursuant to a non-interest bearing promissory note providing for five
consecutive monthly installment payments of $500,000 commencing July 31, 2009
and the KFLP provided a secured loan of $1,000,000 to the
Company. The loan is secured by substantially all of the Company’s
assets (excluding receivables) and bears interest at the rate of Prime plus 4.0%
which is payable quarterly. The principal of the loan is due in five
years. The warrants expire in five years and are immediately
exercisable. We also agreed to provide the KFLP with certain
registration rights in connection with any underwritten or other offering by us
over the next five years. Specifically, we shall include 15% of the
total number of shares publicly offered from the shares to be sold by us to the
KFLP. As a result of the transaction the board of directors
believes there was a change of control of the Company with the KFLP acquiring a
controlling interest of approximately 56.6 % of our outstanding voting common
stock.
In
addition to the above, as a further condition to the consummation of the
transaction contemplated by the Purchase Agreement we were required to obtain
satisfactory arrangements with three main creditors for reductions in the
amounts payable by the Company to them. As of June 30, 2009, these
reductions amounted to $707,674 in aggregate and were conditioned upon prompt
payment of the remaining balances owed to such creditors after taking into
account the agreed upon reductions. As of December 31, 2009, the
amount of reductions arranged with our creditors totaled
$832,959. These agreed upon reductions in payables have been fully
reflected in our financial statements for the period and reported under Other
Income.
In
connection with, and as a closing condition to the Purchase Agreement, the
purchasers, (including George Hawes our largest shareholder prior to this
transaction), under that certain securities purchase agreement dated June 12,
2008, (the “Hawes Agreement”) entered into waiver and release agreements with us
on June 25, 2009. In addition, such individuals waived and
relinquished any special rights they possessed pursuant to agreements with the
Company, including, but not limited to, (i) rights of first refusal (ii)
antidilution regarding future equity sales and (iii) covenants regarding secured
lending contained in the Hawes Agreement. In connection with such
waivers and releases, warrants to acquire 3,220,000 shares of our common stock
at an exercise price of $1.30 per share that were previously issued under the
Hawes Agreement pursuant to the Private Placement in June 2008 were subject to
the right of exchange for new replacement warrants to acquire the same number of
shares under the same terms except for a change in the exercise price from $1.30
to $0.75. In addition, to the extent of any future underwritten registered
offerings of our common stock, or the filing of any resale registration
statement, in each case occurring within five years from the date of the waiver
and release, the purchasers shall have the right to include an aggregate of up
to 5% of the shares being registered in such offering or registration statement,
subject to the discretion, in any underwritten primary offerings, of the
underwriter on the inclusion of shares in the offering to be sold by selling
shareholders.
December
2009 Private Placement
On
December 30, 2009, we completed the initial closing of a private placement of
equity pursuant to a Common Stock Purchase Agreement (the “Securities Purchase
Agreement”) with accredited investors. The Company issued 10,016,250
shares of its Common Stock at a price of $0.25 per share to the investors for
$2,504,062, the payment of which consisted of the following: $2,450,000 in cash
at closing and $54,062.50 pursuant to the cancellation of the same dollar amount
of outstanding deferred compensation obligation owed by the Company to Dr.
Jeffrey Hillman, our Chief Scientific Officer and director. Approximately half
of the total investment, or $1,250,000, was made by the KFLP. In conjunction
with, and as a condition to closing of the financing, the KFLP was issued
4,000,000 shares of the Company's Common Stock at $0.25 per share, which was the
same price per share paid by the investors, in exchange for the cancellation of
its $1.0 million secured note. The loan originally had been secured by
substantially all of the Company's assets (excluding receivables) and required
interest payments at the rate of Prime plus 4.0% which were payable
quarterly.
Approximately
$1.0 million of the total proceeds from the financing are to be allocated to
further the Company's development of its DPOLT synthetic chemistry platform,
essential to the production of the Company's lead antibiotic, MU 1140, subject
to the goals set forth by the two year NSF SBIR Phase II Grant received by the
Company on February 15th, 2008. Such allocation enables the Company to be
eligible to receive up to $500K in matching funds from the NSF; however, there
can be no assurances that this matching grant will in fact be
awarded.
Contemporaneously
with the financing transaction contemplated by the Securities Purchase
Agreement, the KFLP also elected to exercise previously issued warrants (issued
on June 30, 2009 as part of the June 2009 Private Placement) to purchase
1,000,000 shares of Company Common Stock. The warrants were exercised through
the payment by the KFLP of the warrant exercise price of $0.10 per share.
Additionally, Christine L. Koski and Robert C. Koski, as Directors of the
Company, each exercised previously issued options to purchase 100,000 shares of
the Company's Common Stock at the option exercise price of $0.10 per share.
These options were automatically granted to both Christine and Robert Koski when
they became non-employee directors of the Company on June 30, 2009.
On
January 13, 2010, we completed the $3,004,062 private placement
contemplated by the Securities Purchase Agreement and December 2009 Private
Placement and issued another 2,000,000 shares of common stock at a price of
$0.25 per share to the accredited investors for $500,000. Of this
amount the KFLP again participated in one half of the remainder of the aggregate
investment by acquiring 1,000,000 shares for $250,000.
Other
Financings
In March 2010, the Company entered into
a short term note payable for $50,637 with an interest rate of 5.75% to finance
product liability insurance. This note matures January 10,
2011. At March 31, 2010 the outstanding balance due was
$45,573.
On April
15, 2009 we entered into a loan agreement with an accredited investor
for a short term note in the amount of $100,000. On August 21,
2009 we paid the short term note and outstanding accrued interest in
full. The note included an interest rate of 15% per annum
and its maturity date was April 15, 2011. In connection with this
borrowing we also issued warrants to acquire 100,000 shares of our
common stock at an exercise price of $.50 per share and such warrants are
exercisable for five years.
On August
6, 2009 the Company entered into a short term note payable for $70,025 with an
interest rate of 5.75% to finance directors and officers liability
insurance. This note matures on May 24, 2010. At March 31,
2010 the balance due was $14,005.
On May 4,
2009 and June 10, 2009, we borrowed $32,556 and $13,100, respectively,
from Dr. Jeffery Hillman, our founder, Chief Science Officer and
director. These borrowings were to be repaid upon demand by Dr. Hillman,
were unsecured and did not bear interest. The proceeds from
these borrowings were used to purchase inventory for our Consumer
Healthcare products division. On June 29, 2009 the aggregate amount
of these obligations of $45,656 were repaid by us in full through the issuance
of 456,564 shares of our common stock at a price of $.10 per share, which was
the closing price of our common stock on June 29, 2009.
Grants - On September 1, 2009
we received a grant funding from the University of Florida under the prime grant
with the Florida Citrus Production Advisory Council in the amount of
$124,570. The purpose of the University of Florida grant is to
identify disease-specific proteins expressed during citrus greening using our
proprietary PCMAT technology.
Our business is based on
commercializing entirely new and unique technologies, and our current business
plan contains a variety of assumptions and expectations that are subject to
uncertainty, including assumptions and expectations about manufacturing
capabilities, clinical testing cost and pricing, continuing technological
improvements, strategic licensing relationships and other relevant matters.
These assumptions take into account recent financings, as well as expected but
currently unidentified additional financings. We have
experienced losses from operations during the last three fiscal years and have
an accumulated deficit of $27,259,082 as of March 31, 2010. The net
loss from operations for the first three months of 2010 was
$1,747,199. Cash used in operations for the three months ended March
31, 2010 was $1,914,484. As of March 31, 2010, our principal source
of liquidity was $459,125 of cash and cash equivalents and $896,351 of cash
reserved pursuant to a covenant in the December 2009 Securities Purchase
Agreement for further development of our DPOLT synthetic chemistry platform
toward the goal of obtaining additional NSF SBIR Phase II grant
funding. The aforementioned operating results occurred while
developing and attempting to commercialize and manufacture products from
entirely new and unique technologies. Our business plan requires significant
spending related to our commercialization efforts, clinical testing
expenditures, as well as conducting basic research. These factors
place a significant strain on our limited financial resources and adversely
affect our ability to continue as a going concern. Our ultimate
success will likely depend on our ability to continue to raise capital for our
operations.
Our
capital requirements for the remainder of 2010 will depend on numerous factors,
including the success of our commercialization efforts and of our research and
development, the resources we devote to develop and support our technologies and
the success of pursuing strategic licensing and funded product development
relationships with external partners. Subject to our ability to generate revenue
and cash flow from our Consumer Healthcare products division and our ability to
raise additional capital including through possible joint ventures and/or
partnerships, we expect to need to incur substantial expenditures to further
commercialize or develop each of our technologies including continued increases
in costs related to research, advertising, preclinical testing and clinical
studies, as well as significant costs associated with being a public company. We
will require substantial funds to conduct research and development and
preclinical and Phase I clinical testing of our licensed, patented technologies
and to develop sublicensing relationships for the Phase II and III clinical
testing and manufacture and marketing of any products that are approved for
commercial sale. We must generate additional capital resources to enable us to
continue as a going concern. Our plans include seeking financing, alliances or
other partnership agreements with entities interested in our technologies, or
other business transactions that would generate sufficient resources to assure
continuation of our operations and research and development programs as well as
seeking equity financing.
Our
future success depends on our ability to continue to raise capital and
ultimately generate revenue and attain profitability. We cannot be certain that
additional capital, whether through selling additional debt or equity securities
or obtaining a line of credit or other loan, will be available to us or, if
available, will be on terms acceptable to us. If we issue additional securities
to raise funds, these securities may have rights, preferences, or privileges
senior to those of our common stock, and our current stockholders may experience
substantial dilution.
While we
continue to focus on our products and technologies, we currently do not have
sufficient capital resources to market our products and complete the development
of our technologies. We have working capital of $1,523,654 ($627,303
when excluding funds reserved for future development of DPOLT) at March 31,
2010. Our currently available cash and cash equivalents of
$459,125 is insufficient to enable us to continue to operate beyond June 2010.
In the event adequate capital is not raised by this time we would need to
substantially curtail our plan of operations or cease all operations until we
are able to raise additional capital. In addition, we expect to
continue to explore strategic alternatives that may be available to us and our
technologies.
ITEM
4T. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Management's
evaluation of the effectiveness of the Company's disclosure controls and
procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act was
performed under the supervision and with the participation of our senior
management, including our Chief Executive Officer and Chief Financial Officer.
The purpose of disclosure controls and procedures is to ensure that information
required to be disclosed in the reports filed or submitted under the Exchange
Act is recorded, processed, summarized and reported within the time periods
specified in the SEC's rules and forms, and that such information is accumulated
and communicated to management, including our Chief Executive Officer and
Principal Financial Officer, to allow timely decisions regarding required
disclosures.
As previously disclosed under Item 4T,
Controls and
Procedures, in our
Quarterly Reports on Form 10-Q for the quarters ended June 30 and September 30,
2009 and Item 9A(T) Controls and
Procedures in our Form
10-K, management indicated progress had been
made during the quarter to remediate material weaknesses in the internal control
over financial reporting. Based on the continued existence of material
weaknesses, our Chief Executive Officer and Principal Financial Officer have
concluded that, as of the quarter ended March 31, 2010, disclosure controls and
procedures were not effective. Nevertheless, based on a number of factors,
including the performance of additional procedures by management designed to
ensure the reliability of our financial reporting, management believes that the
financial statements in this Quarterly Report on March 31, 2010 Form 10-Q fairly
presented, in all material respects, our financial position, results of
operations, and cash flows for the periods presented in conformity with
GAAP.
As
previously disclosed and referenced above, the matters involving internal
controls and procedures that our management identified and considered to be
material weaknesses were: (1) lack of a functioning audit committee due to a
lack of a majority of independent members and a lack of outside directors on our
board of directors, resulting in ineffective oversight in the establishment and
monitoring of required internal controls and procedures; (2) inadequate staffing
and supervision that could lead to the untimely identification and resolution of
accounting and disclosure matters and failure to perform timely and effective
reviews, (3) limited documentation of our system of internal control, (4)
insufficient personnel to employ segregation of duties; (5) lack of formal
written policies and procedures for accounting and financial reporting with
respect to the requirements and application of U.S. GAAP and SEC disclosure
requirements and related documentation; (6) deficiencies in our material
technology systems and (7) ineffective controls over period end financial
disclosure and reporting processes. In addition, our corporate governance
activities and processes are not always formally documented or adequately
communicated. Specifically, decisions made by the Board to be carried out
by management should be documented and communicated on a timely basis to reduce
the likelihood of any misunderstandings regarding key decisions affecting our
operations and management. These deficiencies and weaknesses were
largely attributable to the significant lack of available financial resources
and corresponding personnel reductions experienced by us during the quarter
ended June 30, 2009.
Management’s
Remediation Initiatives
Although
management has not fully remediated all the material weaknesses mentioned above,
management believes progress has been made. We have continued the
engagement with a consulting firm specializing in Sarbanes-Oxley Section 404
compliance to assist us in the implementation of internal controls for financial
reporting and disclosure and our remediation efforts. During the
quarter the consulting firm completed an initial entity level control evaluation
(ELC), control documentation and gap analysis for financial
close and reporting. Following such evaluation, management
implemented a remediation plan during the quarter and addressed the
documentation of our internal controls, creation of policies and procedures,
control over period end financial disclosures and update of corporate governance
activities and documentation. Management also expects to review
various facets of our information processing system, such as cash disbursements,
sales and billing, cash receipts and other procedures. We continue to evaluate
and address these weaknesses to ensure adherence to our policies, completeness
of reporting, segregation of incompatible duties and compliance with generally
accepted accounting principles; and we intend to continue to monitor and
evaluate these and other factors affecting our internal controls as our
available liquidity permits. Until such time, our internal controls
over financial reporting may be subject to additional material weaknesses and
deficiencies that we have not yet identified. Management is responsible for and
is committed to achieving and maintaining a strong control environment, high
ethical standards, and financial reporting integrity. This commitment
continues to be communicated to, and reinforced with, our
employees.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate. All internal control systems, no matter
how well designed, have inherent limitations. Therefore, even those systems
determined to be effective can provide only reasonable assurance with respect to
financial statement preparation and presentation. Because of the inherent
limitations of internal control, there is a risk that material misstatements may
not be prevented or detected on a timely basis by internal control over
financial reporting. However, these inherent limitations are known features of
the financial reporting process. Therefore, it is possible to design into the
process safeguards to reduce, though not eliminate, this risk.
Changes
in Internal Controls Over Financial Reporting
Except as
indicated in the preceding paragraphs about management’s evaluation of
disclosure controls and procedures and internal controls, our management, with
the participation of our chief executive officer and chief financial officer,
has concluded there were no other significant changes in our internal controls
over financial reporting that occurred during our last fiscal quarter that has
materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
PART
II – OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
We are
not a party to any pending legal proceeding that is not in the
ordinary course of business or otherwise material to our financial condition or
business.
In
addition to the other information set forth in this Form 10-Q, you should
carefully consider the factors discussed in Part I, Item 1A, subsection “Risk
Factors” of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2009 which could materially affect our business, financial
condition or future results of operations. The risks described in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2009 are
not the only risks that we face. Additional risks and uncertainties not
currently known to us or that we currently deem to be immaterial may also
materially adversely affect our business, financial condition and future results
of operations. The specific risk factors set forth below were
included in our Form 10-K Risk Factors and have been updated to provide
information as of March 31, 2010. Other than as set forth below,
there have been no material changes from the risk factors previously disclosed
in Item 1A, subsection “Risk Factors” to Part I of our Annual Report on Form
10-K for the fiscal year ended December 31, 2009.
You
should carefully consider the Risk Factors and the risks described below before
making an investment decision in our securities. These risk factors are
effective as of the date of this Form 10-Q and shall be deemed to be modified or
superseded to the extent that a statement contained in our future filings
modifies or replaces such statement. All of these risks may impair our business
operations. The forward-looking statements in this Form 10-Q involve risks and
uncertainties and actual results may differ materially from the results we
discuss in the forward-looking statements. If any of the following risks
actually occur, our business, financial condition or results of operations could
be materially adversely affected. In that case, the trading price of our stock
could decline, and you may lose all or part of your investment.
Risks
Related to Our Business
We
have a limited operating history with significant losses and expect to continue
to experience losses for the foreseeable future and our independent auditors
have expressed doubt about our ability to continue as a going
concern.
We have
yet to establish any history of profitable operations. Our
profitability will require the successful commercialization of one or more of
the technologies we either license or own. Since our organization, we have
incurred operating losses and negative cash flow from operating activities as a
result of modest sales coupled with our significant clinical development,
research and development, general and administrative, sales and marketing and
business development expenses. Furthermore, our cash burn rate and expenses have
recently increased significantly due to our aggressive commercialization,
marketing and international initiatives. We expect to incur losses for at least
the next several quarters as we expand our sales and marketing capabilities,
make use of the sales and marketing capabilities of third parties and continue
our clinical trials and research and development activities. Losses
have totaled:
$1,747,199
for the three months ended March 31, 2010
$5,519,348
for the year ended December 31, 2009
$6,021,742
for the year ended December 31, 2008
$2,311,712
for the year ended December 31, 2007
$2,935,719
for the year ended December 31, 2006
These
losses, among other things, have had and will continue to have an adverse effect
on our working capital, total assets and stockholders’ equity. In light of our
recurring losses, accumulated deficit and cash flow difficulties, the report of
our independent registered public accounting firm on our financial statements
for the year ended December 31, 2009 contains an explanatory paragraph raising
substantial doubt about our ability to continue as a going concern. Our
financial statements do not include any adjustments that may be necessary in the
event we are unable to continue as a going concern.
We have
experienced losses from operations during the last three years and have an
accumulated deficit of $27,259,082 as of March 31, 2010 and $25,511,883 as of
December 31, 2009. We have an operating cash flow deficit of
$1,914,484 for the three months ended March 31, 2010 and $5,799,481 for the year
ended December 31, 2009 and we sustained operating cash flow deficits of
$3,835,190 and $1,913,760 in 2008 and 2007, respectively. Our
accounts payable and accrued expenses have also increased due to operational
changes instituted in connection with the launch of our consumer
products. At March 31, 2010, December 31, 2009 and December 31, 2008,
we had working capital (deficit) of $1,523,654, $2,564,147 and ($500,672),
respectively.
We
continue to require additional financing to operate beyond June,
2010.
We do not
have sufficient capital to sustain our operations beyond June 2010 and we
require additional financing. If we are not able to raise additional capital,
among other things, we could:
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·
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be
forced to reorganize under the protection of the Federal Bankruptcy
Laws;
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·
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need
to scale back or cease our marketing and development
efforts;
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·
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be
forced to cease operations;
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·
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be
unable to pursue further development of our
technologies;
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·
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be
forced to sell off our technologies prior to maximizing their potential
value;
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·
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be
unable to aggressively market our
products;
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·
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be
unable to pursue patenting some of our technologies and development of our
technologies and products;
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·
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have
to lay-off personnel;
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·
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be
unable to continue to make public filings;
and
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·
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have
our licenses for our SMaRT™ Replacement Therapy technology and MU 1140
technology could be terminated.
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There can
be no assurance that we will be able to raise additional capital and any of
these events would significantly harm our business.
Forward-Looking
Statements
This 10-Q
contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended and Section 21E of the Securities Exchange
Act of 1934, as amended. Such forward-looking statements include statements
regarding, among other things, (a) our need for and availability of working
capital, (b) our financing plans, (c) our strategies, (d) our projected sales
and profitability, (e) anticipated trends in our industry. Forward-looking
statements, which involve assumptions and describe our future plans, strategies,
and expectations, are generally identifiable by use of the words “may,” “will,”
“should,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project”
or the negative of these words or other variations on these words or comparable
terminology. This information may involve known and unknown risks,
uncertainties, and other factors that may cause our actual results, performance,
or achievements to be materially different from the future results, performance,
or achievements expressed or implied by any forward-looking statements. These
statements may be found under “Management’s Discussion and Analysis or Plan of
Operation” and “Business,” as well as in this 10-Q generally. Actual events or
results may differ materially from those discussed in forward-looking statements
as a result of various factors, including, without limitation, the risks
outlined under “Risk Factors” in our Form 10-K and in this 10-Q. In
light of these risks and uncertainties, there can be no assurance that the
forward-looking statements contained in this filing will in fact occur. In
addition to the information expressly required to be included in this filing, we
will provide such further material information, if any, as may be necessary to
make the required statements, in light of the circumstances under which they are
made, not misleading.
ITEM
2. UNREGISTERED SALE OF EQUITY SECURITIES AND USE OF PROCEEDS
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(a)
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We
issued the following restricted securities during the period covered by
this report to the named individual pursuant to exemptions under the
Securities Act of 1933 including
Section 4(2):
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On
January 13, 2010, we completed the $3,004,062 private placement
contemplated by the Securities Purchase Agreement and December 2009 Private
Placement and issued another 2,000,000 shares of common stock at a price of
$0.25 per share to the accredited investors for $500,000. The accredited
investors included the following: Kris A. Persinger, Richard Dresden, John Diana
, Michael Wells First Clearing, LLC C/F Roth IRA FBO Kris A.
Persinger. Of this amount the KFLP again participated in one half of the
remainder of the aggregate investment by acquiring 1,000,000 shares for
$250,000.
ITEM
5. OTHER INFORMATION
Employment
Contracts and Change in Control Arrangements
On March
11, 2010 our Compensation Committee met and approved and authorized new
employment contracts with Mr. David Hirsch, our Chief Executive Officer and
President, Dr. Hillman, our Chief Scientific Officer and Mr. Brian Bohunicky,
our Chief Financial Officer, Secretary and Treasurer. Each of the employment
agreements have substantially similar terms other than with respect to their
annual compensation and title (the "Employment Agreements"). As to Mr. Hirsch
and Dr. Hillman the new agreements replaced existing employment agreements and
as to Mr. Bohunicky the employment agreement constitutes a new agreement between
us and Mr. Bohunicky. The annual base salaries provided in the Employment
Agreements are $225,000, $200,000 and $200,000 for Mr. Hirsch, Dr. Hillman and
Mr. Bohunicky, respectively payable in installments consistent with our normal
payroll practices, do not represent a change from our previously disclosed
compensation levels. The executive officers are also eligible under the
Employment Agreements to receive bonuses during the term at the discretion of
the Compensation Committee and the Board of Directors.
The
Employment Agreements are terminable at any time by either
party and if the executive officer is involuntarily
terminated by us he shall receive his base salary and vacation pay
each accrued through the date of termination, and any nonforfeitable benefits
earned and payable to him under the terms of the employee
handbook (which applies to all employees) and benefits available under any
applicable incentive plan which employee participates. In
addition, if the executive officers separation from employment is not
voluntary and without cause, we would be obligated to pay the executive
officer six months of his annual base salary as severance and the
executive shall be entitled to out placement service benefits. If the
executive officer is terminated for cause, he shall be entitled to receive his
base salary and accrued vacation due through the date of termination
and any nonforfeitable benefits already earned and payable to the
executive under the terms of the employee handbook or other applicable
incentive plans maintained by us. Cause is defined in the Employment
Agreements as any action that is illegal, immoral, or improper that reflects on
the Company, the Employee, or the ability of either to function optimally.
If the executive officer voluntarily resigns, he shall be
entitled to this base salary and accrued vacation due through the
date of termination (including any mutually agreed upon notice period) and
any nonforfeitable benefits already earned and payable to the executive
officer under the terms of the employee handbook or other
incentive plans maintained by us.
If the
executive officer dies during the term of employment with us, the estate of the
employee shall be paid the salary of the employee as it would have accrued over
a period of thirty days after the executive officers death. We shall also
extend the executive officers right to exercise vested stock options for six
months provided such extension is permitted under the Plan. In the event
the executive officer becomes disabled (as defined in the any then applicable
short and long-term disability insurance policies) we shall pay to the executive
officer the executive officers salary as it would have accrued over a period of
thirty (30) days after the executive became so disabled and we shall extend the
executive officers right to exercise vested stock options for six months
provided such extension is permitted under the Plan.
In the
event of a Change in Control any stock options or other awards granted
(other than performance awards) under our Amended and Restated Stock
Option and Incentive Plan (as amended, the "Plan") shall become
immediately vested in full and in the case of stock options exercisable in
full. If the change in control results in an involuntary
separation from employment of the executive officer within 180
days following a change in control, the executive officer would be
entitled to (i) receive six (6) months of salary and the
extension of his benefits (excluding vacation time and paid time off) for a six
month period and (ii) exercise vested options for six months from the date
of separation, provided said extension period is allowed under the
Plan. Under the Employment Agreements, "involuntary separation of
employment" means (i) termination without cause, (ii) any reduction in
responsibilities of office altering the status of the executive officer as an
employee, or (iii) the duplication of the executive officers position by an
equivalent executive in an acquiring entity and "Change in Control" means the
sale of the entire company, or substantially all of its assets, or the sale of
the business unit employing an individual which results in the termination of
employment or subsequent transfer of the employment relationship to another
legal entity, or entity, or single party acquiring more shares than are owned by
the Koski Family Limited Partnership, including its members and their immediate
families (including spouses and their children).
The Employment Agreements
also each include non-disclosure and Company ownership of development
provisions, as well as a provision providing for the Company to defend and
indemnify the executive if the executive is named as a defendant in any lawsuit
regarding any action taken within the scope of
employment.
ITEM
6. EXHIBITS
Incorporated by reference to Exhibits
filed after signature page.
SIGNATURES
In
accordance with the requirements of the Exchange Act, the registrant caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized
on this 13 day of May, 2010.
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ORAGENICS,
INC.
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BY:
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/s/
David B. Hirsch
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David
B. Hirsch, President and Chief Executive
Officer
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EXHIBIT
INDEX
Incorporated
by Reference
Exhibit
Number
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Exhibit Description
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Form
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File No
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Exhibit
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Filing Date
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Filed
Herewith
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10.1
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Executive
Employment Agreement for David B. Hirsch.
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X
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10.2
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Executive
Employment Agreement for Jeffrey D. Hillman.
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X
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10.3
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Executive
Employment Agreement for Brian J. Bohunicky.
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X
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31.1
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Certification
of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
promulgated under the Securities and Exchange Act of 1934, as
amended.
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X
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31.2
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Certification
of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
promulgated under the Securities and Exchange Act of 1934, as
amended.
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X
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32.1
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Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (Chief Executive Officer).
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X
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32.2
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Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (Chief Financial Officer).
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X
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