Registration
Number 333-163882
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC
20549
Form S-1
REGISTRATION
STATEMENT
UNDER
THE SECURITIES ACT
OF 1933
INVO
BIOSCIENCE, INC.
(Exact
name of registrant as specified in its charter)
|
|
|
|
|
Nevada
|
|
3841
|
|
20-4036208
|
(State
or other jurisdiction of
incorporation
or organization)
|
|
(Primary
Standard Industrial
Classification
Code Number)
|
|
(IRS
Employer
Identification
No.)
|
100 Cummings Center,
Suite 421E
Beverly,
Massachusetts 01915
(978) 878-9505
(Address, including
zip code, and telephone number, including area code, of registrant’s principal
executive offices)
Kathleen T.
Karloff
Chief Executive
Officer
INVO Bioscience,
Inc.
100 Cummings Center,
Suite 421E
Beverly,
Massachusetts 01915
(978) 878-9505
extension 504
(Name, address,
including zip code, and telephone number, including area code, of agent for
service)
Scott
Museles, Esq.
Shulman, Rogers,
Gandal, Pordy & Ecker, P.A.
12505 Park Potomac
Avenue 6
th
Floor
Potomac, Maryland
20854
(301)
230-5200
Approximate date of commencement of
proposed sale to the public:
From time to time after this
Registration Statement becomes effective.
If any of
the securities being registered on this Form are being offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, as
amended, check the following box.
þ
If this
Form is filed to register additional securities for an offering pursuant to
Rule 462(b) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering.
o
If this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier registration statement for the same
offering.
o
If this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier registration statement for the same
offering.
o
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. (Check
one):
|
|
|
|
|
|
|
Large
accelerated filer
o
|
|
Accelerated
filer
o
|
|
Non-accelerated
filer
o
(Do
not check if a smaller reporting company)
|
|
Smaller
reporting company
þ
|
The Registrant hereby amends this
Registration Statement on such date or dates as may be necessary to delay its
effective date until the Registrant shall file a further amendment which
specifically states that this Registration Statement shall thereafter become
effective in accordance with Section 8(a) of the Securities Act of 1933, as
amended, or until the Registration Statement shall become effective on such date
as the Securities and Exchange Commission, acting pursuant to Section 8(a),
may determine.
The information in this prospectus is
not complete and may be changed. We may not sell these securities
until the registration statement filed with the Securities and Exchange
Commission is effective. This prospectus is not an offer to sell
these securities and it is not soliciting an offer to buy these securities in
any state where the offer or sale is not permitted
.
Subject
to Completion, December 28, 2009
PRELIMINARY
PROSPECTUS
8,790,000
Share
Common
Stock
This
prospectus relates to shares of common stock of INVO Bioscience, Inc. that may
be sold by AGS Capital Group, LLC (“
AGS
”), the selling
shareholder identified in this prospectus. The shares of common stock offered
under this prospectus by AGS are issuable to AGS pursuant to a Reserved Equity
Financing Agreement (“
REF
”) between AGS and
us dated October 28, 2009. We are registering the offer and sale of the shares
to satisfy registration rights we have granted to AGS. We will not receive any
proceeds from the sale of these shares by AGS. This registration
statement covers only a portion of the shares of common stock that may be
issuable pursuant to the REF. We may file subsequent registration statements
covering the resale of additional shares of common stock issuable pursuant to
the REF with AGS beginning approximately 60 days after we have substantially
completed the sale to AGS under the REF of the shares subject to this
registration statement. We will bear all costs associated with this registration
statement.
AGS may
sell the shares of common stock described in this prospectus in a number of
different ways and at varying prices. We provide more information about how AGS
may sell its shares of common stock in the section entitled “Plan of
Distribution.” AGS is an “underwriter” within the meaning of the Securities Act
of 1933, as amended (the “
Securities Act
”) in
connection with the resale of our common stock under the REF. AGS
will pay us 92% of the volume weighted average price of the common stock during
the five consecutive trading days immediately following the date of our notice
to AGS of our election to sell shares to AGS pursuant to the REF.
Our
shares of common stock are traded on the Over-the-Counter Bulletin Board (the
“
OTCBB
”) under
the symbol "IVOB.OB." On December 11, 2009, the closing sale price of our common
stock was $0.33 per share.
This
investment involves a high degree of risk. You should purchase shares only if
you can afford a complete loss. See "
Risk Factors
"
beginning on page 5.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal
offense.
The
date of this prospectus is December 28,
2009
|
|
Page
|
|
|
|
|
|
|
|
|
1
|
|
|
|
|
5
|
|
|
|
|
|
|
|
|
|
12
|
|
|
|
|
12
|
|
|
|
|
13
|
|
|
|
|
13
|
|
|
|
|
14
|
|
|
|
|
15
|
|
|
|
|
20
|
|
|
|
|
27
|
|
|
|
|
29
|
|
|
|
|
31
|
|
|
|
|
31
|
|
|
|
|
32
|
|
|
|
|
32
|
|
|
|
|
33
|
|
|
|
|
35
|
|
|
|
|
35
|
|
|
|
|
35
|
|
|
|
|
F-1
|
|
|
|
You
should rely only on the information contained or incorporated by reference into
this prospectus. We have not, and the selling shareholder has not, authorized
anyone to provide you with additional or different information. These securities
are not being offered in any jurisdiction where the offer is not permitted. You
should assume that the information in this prospectus is accurate only as of the
date on the front of the document and that any information we have incorporated
by reference is accurate only as of the date of the document incorporated by
reference, regardless of the time of delivery of this prospectus or of any sale
of our common stock. Unless the context otherwise requires, references to “we,”
“our,” “us,” or the “Company” in this prospectus mean INVO Bioscience, Inc. a
Nevada corporation.
This
summary highlights information described more fully elsewhere in this
prospectus. You should read the entire prospectus carefully,
including the risk factors, the financial statements and the notes to the
financial statements included herein. Investing our securities involves risks.
Therefore, please carefully consider the information provided under the heading
“Risk Factors” included herein.
The
Company
We are a
development stage company that has recently begun to commercialize our proven
and patented technology that we believe will revolutionize the treatment of
infertility. Our device, the INVOcell, and the INVO procedure are
designed to provide an alternative infertility treatment for the patient and the
clinician; it is less expensive and simpler to perform than current infertility
treatments. The simplicity of the INVO procedure relates to the
ability to potentially perform the infertility procedure in a physician’s
practice rather than in a specialized facility at a much lower cost overall than
current infertility treatments, including in vitro fertilization (“
IVF
”). Therefore,
we believe that the INVO procedure will be available in many more locations than
conventional IVF especially outside the United States. INVO also
allows conception and embryo development to take place inside the woman's body;
an attractive feature for most couples.
Through
September 30, 2009, we have generated minimal revenues, have incurred
significant expenses and have sustained losses. Consequently, our
operations are subject to all the risks inherent in the establishment of a new
business enterprise.
In May
2008, we received notice that the INVOcell product meets all the essential
requirements of the relevant European Directive(s), and received CE
Marking. The CE marking (also known as CE mark) is a mandatory
conformity mark on many products placed on the single market in the European
Economic Area (EEA). The CE marking (an acronym for the French
“Conformité Européenne”) certifies that a product has met EU health, safety and
environmental requirements, which ensure consumer safety.
With CE
Marking, we now have the ability and necessary regulatory authority to
distribute our product in the European Economic Area (i.e., the European Union,
Canada, Australia, New Zealand, and most parts of the Middle
East). The Company has sold approximately 900 INVOcell units to date
since we commenced sales in the late fall 2008.
Our
principal executive offices are located at 100 Cummings Center Suite 421e,
Beverly, MA 01915, and our telephone number is (978) 878-9505. The
address of our website is www.INVOBioscience.com. Information on our
website is not part of this prospectus.
The
INVOcell Technology
Our
product, the INVOcell medical device, is designed to treat infertility at a far
lower cost than other treatments available in today’s marketplace, including
IVF. The INVO technology is a fertility treatment where either mild
ovarian stimulation or no ovarian stimulation is used. Using a mild
stimulation protocol, 1-10 follicles are retrieved in a physician’s office with
the patient under light sedation with or without local
anesthesia. The follicle retrieval is performed using a vaginal probe
under ultrasound guidance. Eggs are identified immediately after
retrieval in the follicular fluid. During the INVO procedure,
fertilization and embryo development occurs inside the woman’s vaginal cavity in
a disposable single use device -- the INVOcell -- that holds the eggs, sperm and
culture medium.
Sperm
collection and preparation generally occur before egg
retrieval. Nutrient medium (~1ml) is placed in the inner vessel of
the INVOcell. Eggs and a fraction of motile sperm are placed into the
medium and the inner vessel is closed and secured in the protective outer rigid
shell. The INVOcell is placed in the patient’s vaginal cavity for an
incubation period of 2-3 days. A retention system can be used to
maintain the INVOcell system in the vagina during the incubation
period. The retention system consists of a diaphragm with holes in
the membrane to allow natural elimination of vaginal secretions. The
INVOcell is designed so that no vaginal fluids penetrate the outer vessel thus
ensuring that the inner vessel is not contaminated. Obtaining eggs,
sperm and media then inserting them into the INVOcell and then placing it in the
vagina takes approximately 90 minutes.
After 2-3
days, the patient returns to the physician’s office where the retention system
and the INVOcell are removed. The protective outer vessel is
discarded and the inner vessel is placed in INVO Bioscience’s patented holding
block in a vertical position for 15 minutes. Embryos are collected in
the micro chamber located at the bottom of the inner vessel. The
embryos can be directly viewed in the micro chamber in the holding block by
using a microscope. Embryos can be loaded directly from the device in
a transfer catheter from the INVOcell device. A trained clinician can
readily identify the best embryos for transfer. The embryos to be
transferred are aspirated into a standard catheter for transfer into the
patient’s uterus. This second visit should take approximately 45
minutes. All INVO related medical procedures can be performed in a
physician’s office thereby avoiding the requirement of an IVF facility and the
associated costs to build and maintain such a facility.
Our
Equity Financing Facility with AGS Capital Group, LLC
On
October 28, 2009, we entered into a Reserve Equity Financing Agreement, or REF,
with AGS pursuant to which AGS committed to purchase, from time to time over a
period of two years, shares of our common stock for cash consideration of up to
$10 million, subject to certain conditions and limitations discussed
below. In connection with the REF, we also entered into a
registration rights agreement with AGS, dated October 28, 2009. We have not
engaged in prior securities transactions with AGS or any affiliates of
AGS.
The
shares of common stock that may be issued to AGS under the REF will be issued
pursuant to an exemption from registration under the Securities Act. Pursuant to
the registration rights agreement, we have filed a registration statement, of
which this prospectus is a part, covering the possible resale by AGS of a
portion of the shares that we may issue to AGS under the REF. Through this
prospectus, the selling shareholder may offer to the public for resale shares of
our common stock that we may issue to AGS pursuant to the REF.
This
registration statement covers only a portion of the shares of our common stock
issuable pursuant to the REF with AGS. We may file subsequent registration
statements covering the resale of additional shares of our common stock issuable
pursuant to the REF with AGS beginning approximately 60 days after we have
substantially completed the sale to AGS under the REF of the shares subject to
this registration statement.
For a
period of 24 months from the effectiveness of the registration statement of
which this prospectus is a part (the “
Registration
Statement
”), we may, from time to time, at our discretion, and subject to
certain conditions that we must satisfy, draw down funds under the REF by
selling shares of our common stock to AGS up to an aggregate of $10 million. The
purchase price of these shares will be 92% of the “VWAP” of the common stock
during the five consecutive trading days after we give AGS a notice of an
advance of funds (an “
Advance
”) under the
REF (the “
Pricing
Period
”). “
VWAP
” generally
means, as of any date, the daily dollar volume weighted average price of our
common stock as reported by Bloomberg, L.P. or comparable financial news
service. The amount of an Advance will automatically be reduced by
50% if on any day during the Pricing Period, the VWAP for that day does not meet
or exceed 85% of the VWAP for the five trading days prior to the notice of
Advance (the “
Floor
Price”)
.
The REF
does not prohibit us from raising additional debt or equity financings, other
than financings similar to the REF.
Our
ability to require AGS to purchase our common stock is subject to various
conditions and limitations. The maximum amount of each Advance is 100% of the
average daily trading volume for the five days immediately preceding the notice
of Advance, as reported by Bloomberg or comparable financial news service (the
“
Maximum Advance
Amount
”). In addition, unless AGS agrees otherwise, a minimum
of five calendar days must elapse between each notice of Advance.
Before
AGS is obligated to buy any shares of our common stock pursuant to a notice of
Advance, the following conditions, none of which is in AGS’s control, must be
met:
·
|
The
Registration Statement (which includes this prospectus) shall have
previously become effective and shall remain effective in accordance with
and subject to the terms of the registration rights
agreement.
|
·
|
We
shall have obtained all permits and qualifications required by any
applicable state in accordance with the registration rights agreement for
the offer and sale of the shares of common stock, or shall have the
availability of exemptions there from. The sale and issuance of the shares
of common stock shall be legally permitted by all laws and regulations to
which we are subject.
|
·
|
There
shall not be any fundamental changes to the information set forth in the
Registration Statement which are not already reflected in a post-effective
amendment to the Registration
Statement.
|
·
|
We
shall have performed, satisfied and complied in all material respects with
all covenants, agreements and conditions required by the REF and the
registration rights agreement to be performed, satisfied or complied with
by us.
|
·
|
No
statute, rule, regulation, executive order, decree, ruling or injunction
shall have been enacted, entered, promulgated or endorsed by any court or
governmental authority of competent jurisdiction that prohibits the
consummation of or which would materially modify or delay any of the
transactions contemplated by the REF agreement, and no proceeding shall
have been commenced that may have the effect of prohibiting the
consummation of or materially modify or delay any of the transactions
contemplated by the REF.
|
·
|
The
common stock is trading on a principal market (as defined in the REF, and
including the OTC Bulletin Board). The trading of the common stock is not
suspended by the SEC or the principal market. The issuance of shares of
common stock with respect to the applicable closing will not violate the
shareholder approval requirements of the principal market. We shall not
have received any notice threatening the continued quotation of the common
stock on the principal market and we shall have no knowledge of any event
which would be more likely than not to have the effect of causing the
common stock to not be trading or quoted on a principal
market.
|
·
|
The
amount of an Advance shall not exceed the Maximum Advance Amount. In no
event shall the number of shares issuable to AGS pursuant to an Advance
cause the aggregate number of shares of common stock beneficially owned by
AGS and its affiliates to exceed 4.99% of the then outstanding shares of
our common stock (“
Ownership
Limitation
”). Any portion of an Advance that would cause AGS to
exceed the Ownership Limitation shall automatically be withdrawn. For the
purposes of this provision, beneficial ownership is calculated in
accordance with Section 13(d) of the Securities Exchange Act of 1934, as
amended (the “
Exchange
Act
”).
|
·
|
We
have no knowledge of any event which would be more likely than not to have
the effect of causing such Registration Statement to be suspended or
otherwise ineffective at closing.
|
·
|
AGS
shall have received an Advance notice executed by an officer of ours and
the representations contained in such Advance notice shall be true and
correct.
|
There is
no guarantee that we will be able to meet the foregoing conditions or any other
conditions under the REF or that we will be able to draw down any portion of the
amounts available under the REF.
The
Registration Statement covers only 8,790,000 shares of common stock under the
REF. The entire share requirement for the full $10 million under the REF
would be approximately 32,938,000 based on an assumed VWAP of $0.33 less the 8%
discount. However, we have decided to limit ourselves to 8,790,000
shares available, or $2,668,000, based on current market prices. If our
share price rises, we will be able to draw down in excess of $2,668,000. If we
decide to issue more than 8,790,000 shares, we will need to file one or more
additional registration statements with the SEC covering those
additional shares.
The REF
contains representations and warranties by us and AGS which are typical for
transactions of this type.
AGS
agreed that during the term of the REF, neither AGS nor any of its affiliates,
nor any entity managed or controlled by it, will, or cause or assist any person
to, enter into or execute any short sale of any shares of our common stock as
defined in Regulation SHO promulgated under the Exchange Act. The REF
also contains a variety of covenants by us which are typical for transactions of
this type, as well as the obligation, without the prior written consent of AGS,
not to enter into any other agreement similar to the REF with a third party
during the term of the REF.
The REF
obligates us to indemnify AGS for certain losses resulting from a
misrepresentation or breach of any representation or warranty made by us or
breach of any obligation of ours. AGS also indemnifies us for similar
matters.
We paid
no fees, and are not obligated to pay any fees in the future, to AGS in
connection with the REF, other than a due diligence fee of $10,000, all of which
has been paid as of the date hereof.
We may
terminate the REF effective upon fifteen trading days’ prior written notice to
AGS; provided that (i) there are no Advances outstanding, and (ii) we
have paid all amounts owed to AGS pursuant to the REF. The obligation of AGS to
make an Advance to us pursuant to the REF shall terminate permanently if
(i) there shall occur any stop order or suspension of the effectiveness of
the Registration Statement for an aggregate of 50 trading days, or
(ii) we shall at any time fail materially to comply with certain covenants
specified in the REF and such failure is not cured within 30 days after
receipt of written notice from AGS, subject to exceptions.
The
issuance of our shares of common stock under the REF will have no effect on the
rights or privileges of existing holders of common stock except that the
economic and voting interests of each stockholder will be diluted as a result of
the issuance of our shares. Although the number of shares of common
stock that stockholders presently own will not decrease, these shares will
represent a smaller percentage of our total shares that will be outstanding
after any issuances of shares of common stock to AGS. If we draw down
amounts under the REF when our share price is decreasing, we will need to issue
more shares to raise the same amount than if our stock price was
higher. Such issuances will have a dilutive effect and may further
decrease our stock price. An example of the effect of issuing shares when our
stock price is comparatively low is set forth below.
Under the
REF, the purchase price of the shares to be sold to AGS will be at a discount of
8% from the volume weighted average price of our common stock for each of the
five trading days following our election to sell shares to AGS. The table below
illustrates an issuance of shares of common stock to AGS under the REF for a
hypothetical draw down amount of $50,000 at an assumed volume weighted average
price of $0.33, which is equal to the closing price of our common stock on the
OTC Bulletin Board on December 11, 2009.
Draw
Down
|
|
|
|
|
|
|
|
|
Price
to be Paid by
|
|
|
Number
of Shares
|
|
Amount
|
|
|
VWAP
|
|
|
%
Discount
|
|
|
AGS
|
|
|
to be
Issued
|
|
$
|
50,000
|
|
|
$
|
0.33
|
|
|
|
8
|
%
|
|
$
|
0.30
|
|
|
|
164,690
|
|
By
comparison, if the volume weighted average price of our common stock was lower
than $0.33, the number of shares that we would be required to issue in order to
have the same draw down amount of $50,000 would be larger, as shown by the
following table:
Draw
Down
|
|
|
|
|
|
|
|
|
Price
to be Paid by
|
|
|
Number
of Shares
|
|
Amount
|
|
|
VWAP
|
|
|
%
Discount
|
|
|
AGS
|
|
|
to be
Issued
|
|
$
|
50,000
|
|
|
$
|
0.30
|
|
|
|
8
|
%
|
|
$
|
0.276
|
|
|
|
181,160
|
|
Accordingly,
the effect of the second example outlined above from the first example outlined
above, would be dilution of an additional 16,470 shares issued due to the
lower stock price. In effect, a lower price per share of our common stock means
a higher number of shares to be issued to AGS, which equates to greater dilution
of existing stockholders. The effect of this dilution may, in turn, cause the
price of our common stock to decrease further, both because of the downward
pressure on the stock price that would be caused by a large number of sales of
our shares into the public market by AGS, and because our existing stockholders
may disagree with a decision to sell shares to AGS at a time when our stock
price is low, and may in response decide to sell additional numbers of shares,
further decreasing our stock price.
There is
no limit to the number of shares that we may be required to obtain funds from
the REF as it is dependent upon our trading volume and share price, which varies
from day to day. This also could cause significant downward pressure on the
price of our common stock. The following table shows the effect on the number of
shares required for an Advance for the value of the full $10 million REF, in the
event the common stock price declines by 25%, 50% and 75% from the trading
price.
|
|
|
|
|
Price
Decreases By
|
|
|
|
12/11/2009
|
|
|
|
25%
|
|
|
|
50%
|
|
|
|
75%
|
|
VWAP
during the Purchase Period (as defined above)
|
|
$
|
0.33
|
|
|
$
|
0.248
|
|
|
$
|
0.165
|
|
|
$
|
0.083
|
|
Purchase
Price (defined above as 92% of the VWAP)
|
|
$
|
0.304
|
|
|
$
|
0.228
|
|
|
$
|
0.152
|
|
|
$
|
0.076
|
|
Number
Subject to the REF if 100% of the REF is Executed.
|
|
|
32,938,076
|
|
|
|
43,917,435
|
|
|
|
65,876,152
|
|
|
|
131,752,306
|
|
We
entered into the REF with the intention to grow our business, which in turn
should increase our value. Because of the nature of the REF it appears unlikely
that we will be able to draw down the full $10 million without significant
positive value being added as a result of the aggregate draw downs. In addition,
as reflected above, if our share price declines significantly and we still
desire to draw down on the REF, in addition to having to file one or more
additional registration statements, we may need to amend our charter to increase
our authorized shares of common sock, which is currently 200 million
shares.
Placement
Agent
We
engaged Gilford Securities, Inc. (“
Gilford
”) to act as
placement agent on a non-exclusive basis in connection with the
REF. Gilford will receive a cash commission equaling six percent (6%)
of the total proceeds received by us from the sale of securities sold to
AGS. In addition, we have issued to Gilford and/or its designees, for
a total cost of one dollar, 600,000 shares of our common stock. If we
elect to (and have the ability to) have a closing under the REF on more than
$6,000,000, then we shall issue and sell to Gilford and/or its designees, for a
total cost of one dollar, an additional 400,000 shares of our common
stock.
We agreed
to pay all reasonable expenses, not to exceed $10,000, incurred by Gilford in
connection with the negotiation, preparation and execution of the definitive
documents in connection with the REF, including but not limited to attorneys’
fees and consulting expenses, in two installments. The first
installment of $5,000 was paid in connection with the execution of the
definitive documents, and the balance will be due upon the first funding under
the REF based on actual expenses. The placement agent agreement
also contains customary mutual indemnification provisions.
The
Offering
|
|
|
|
Common
stock offered:
|
Up
to 8,790,000 shares of common stock, $.0001 par value, to be offered for
resale by AGS.
|
Common
stock to be outstanding
after
this offering:
|
Approximately
66,800,000 shares.
|
Use
of proceeds:
|
We
will not receive any proceeds from the sale of the shares of common stock
offered by AGS. However, we will receive proceeds from the Reserved Equity
Financing. See “Use of Proceeds”.
|
Risk
factors:
|
An
investment in our common stock involves a high degree of risk. See “Risk
Factors” beginning on page 6 of this prospectus.
|
OTC
Bulletin Board symbol:
|
“IVOB.OB”
|
Investing
in our shares of common stock is very risky. Before making an
investment decision, you should carefully consider all of the risks described in
this prospectus. If any of the risks discussed in this prospectus
actually occur, our business, financial condition and results of operations
could be materially and adversely affected, the price of our shares could
decline significantly, and you might lose all or a part of your
investment. The risk factors described below are not the only ones
that may affect us. Our forward-looking statements in this prospectus
are also subject to the following risks and uncertainties. In
deciding whether to purchase our shares, you should carefully consider the
following factors, among others, as well as information contained in this
prospectus.
Risks
Relating to Our Company
Our
business has posted net operating losses, has limited operating history and our
independent certified public accountants have raised doubts about our ability to
continue as a going concern.
For the
year ended December 31, 2008, our independent auditor issued a report relating
to our audited financial statements which contains a qualification with respect
to our ability to continue as a going concern because, among other things, our
ability to continue as a going concern is dependent upon our ability to generate
profits from operations in the future or to obtain the necessary financing to
meet our obligations and repay our liabilities when they come due. The financial
statements do not include any adjustments that might be necessary if we are
unable to continue as a going concern.
As
reflected in our most recent unaudited condensed consolidated financial
statements, we have incurred a net loss for the most recent three months ended
September 30, 2009 of $3,409,000 and a cumulative net loss of $6,586,000, a
working capital deficiency of $4,677,000, a stockholder deficiency of $4,577,000
and cash used in operations of $673,000 for the nine months ended September 30,
2009. This raises substantial doubt about our ability to continue as
a going concern. The adverse effects of a limited operating history include
reduced management visibility into forward sales, marketing costs, and customer
acquisition, which could lead to missing targets for achievement of
profitability.
We
need additional capital to continue operations; if we do not raise additional
capital, we will need to curtail or cease operations.
Since our
inception, we have financed our operations primarily through the sale of our
common stock and convertible notes and loans from management. On September
30, 2009, we had $194,405 in cash. To execute on our business plan
successfully, we will need to raise additional money in the future.
Additional financing may not be available on favorable terms, or at all.
The exact amount of funds raised, if any, will determine how quickly we
can complete our clinical trials that are required to receive FDA approval to
market and sell our products in the United States and how aggressively we can
grow our business internationally. No assurance can be given that we
will be able to raise capital when needed or at all, or that such capital, if
available, will be on terms acceptable to us. If we are not able to
raise additional capital, we will likely need to curtail or cease
operations. Although we have entered into the REF with AGS, there can
be no assurance that we will be successful in raising any capital pursuant to
the REF. Other than the REF, we currently have no commitments for funding. If
adequate funds are not available when required, we will need to curtail or cease
operations.
We
are required by the FDA to conduct a clinical trial related to our INVOcell
device. As noted above, we need additional capital to undertake the clinical
trial. In addition, the clinical trial may prove
unsuccessful. If unsuccessful, we will not be able to market and sell
our product in the United States, which would materially adversely affect our US
business.
We are
looking to use some of the funds from the REF to conduct a clinical trial
related to the INVOcell device. We anticipate that it will take nine months
and approximately $1,000,000 of funding to complete the data collection on all
required subjects, analyze the data, have an independent audit and submit the
full 510(k) to the FDA. The FDA has 90 days to review the submission
from INVO Bioscience. All preclinical data and testing has been
completed and reviewed by FDA. There is no assurance that our
clinical trial will be successful. An unsuccessful trial would affect
the marketability in the U.S. of this product in the future and will prevent the
receipt of FDA clearance, which would materially adversely affect our
business.
Our
business is subject to significant competition, including from more established
infertility treatments such as IVF.
The
infertility industry is highly competitive and characterized by technological
improvements. New artificial reproductive technology (“ART”)
services, devices and techniques may be developed that may render obsolete the
INVOcell. Competition in the areas of infertility and ART services is
largely based on pregnancy rates and other patient
outcomes. Accordingly, the ability of our business to compete is
largely dependent on our ability to achieve adequate pregnancy rates and patient
satisfaction levels. Our business operates in highly competitive
areas that are subject to continual change. New health care providers
and medical technology companies entering the market may reduce our market
share, patient volume and growth rates. Additionally, increased
competitive pressures may require us to commit more resources to our marketing
efforts, thereby increasing our cost structure and affecting our
profitability. There can be no assurance that we will be able to
compete effectively nor can there be assurance that additional competitors will
not enter the market, or that such competition will not make it more difficult
for us to enter into additional contracts with fertility clinics.
We
need to manage growth in operations to maximize our potential
growth.
In order
to maximize potential growth in our current and potential markets, we believe
that we must expand the scope of our services in the bioscience
industry. This expansion will place a significant strain on our
management and our operational and sales systems. We expect that we
will need to continue to improve our INVO technology, operating procedures and
management information systems. We will also need to effectively
train, motivate and manage our employees. Our failure to manage our
growth could disrupt our operations and ultimately prevent us from generating
the revenues we expect.
Our
internal growth strategy may not be successful which may result in a negative
impact on our growth, financial condition, results of operations and cash
flow.
One of
our strategies is to grow internally through increasing the customers we
target. However, many obstacles to this expansion exist, including,
but not limited to, increased competition from similar businesses, unexpected
costs, costs associated with marketing efforts and maintaining a strong client
base. Therefore, we cannot assure you that we will be able to
successfully overcome such obstacles and establish our services in any
additional markets. Our inability to implement this internal growth
strategy successfully may have a negative impact on our growth, future financial
condition, results of operations or cash flows.
Our products incorporate intellectual
property rights
developed by us that
may be difficult to protect or
may be found to infringe on the
rights of others
.
While we
currently own four patents, there can be no assurance that any of these patents
will not be challenged, invalidated or circumvented, or that any rights granted
under these patents will in fact provide competitive advantages to us. The
United States, European Union and other jurisdictions could place restrictions
on the patentability of medical devices. Any limitations on the patentability of
medical devices may materially adversely affect our business. We utilize a
combination of trade secrets, confidentiality policies, non-disclosure and other
contractual arrangements in addition to relying on patent, copyright and
trademark laws to protect our intellectual property rights. However, these
measures may not be adequate to prevent or deter infringement or other
misappropriation. Moreover, we may not be able to detect unauthorized use
or take appropriate and timely steps to establish and enforce our proprietary
rights. In fact, existing laws of some countries in which we conduct
business or intend to conduct business offer only limited protection of our
intellectual property rights, if at all. As the number of market
entrants as well as the complexity of the technology increases, the possibility
of functional overlap and inadvertent infringement of intellectual property
rights also increases. Our limited capital resources could put us at
a disadvantage if we are required to take legal action to enforce our
intellectual property rights.
We
must defend our intellectual property rights from infringement through extensive
legal action.
Third
parties may assert in the future claims against us alleging that we
infringe their intellectual property rights. Defending such claims may be
expensive, time consuming and divert the efforts of our management and/or
technical personnel. As a result of litigation, we could be
required to pay damages and other compensation, develop non-infringing products
or enter into royalty or licensing agreements. However, we cannot
be certain that any such licenses, if available at all, will be available to us
on commercially reasonable terms.
We
face potential liability as a provider of a medical device. These
risks may be heightened in the area of artificial reproduction.
The
provision of medical devices entails the substantial risk of potential claims of
tort injury claims. We do not engage in the practice of medicine or
assume responsibility for compliance with regulatory requirements directly
applicable to physicians. Although we currently maintain product
liability insurance that we believe is adequate as to risk and amount,
successful claims could exceed the limits of our insurance and could have a
material adverse effect on our business, financial condition or operating
results. Moreover, there can be no assurance that we will be able to
obtain such insurance on commercially reasonable terms in the future or that any
such insurance will provide adequate coverage against potential
claims. In addition, a claim asserted against us could be
costly to
defend, could consume management resources and
could adversely affect our reputation and business, regardless of
the merit or eventual outcome of such claim.
There are
inherent risks specific to the provision of infertility and ART
services. For example, the long-term effects on women of the
administration of fertility medication, integral to most infertility and ART
services, are of concern to certain physicians and others who fear the
medication may prove to be carcinogenic or cause other medical
problems. Currently, fertility medication is critical to most
infertility and ART services and a ban by the FDA or foreign regulatory or other
limitation on its use would have a material adverse effect on our
business.
If
we fail to maintain adequate quality standards for our products, our business
may be adversely affected and our reputation harmed.
Our
customers are expecting that our products will perform as we
claim. Our manufacturing companies and packaging processes will be
relied up on heavily. A failure to sustain the specified quality
requirements could result in the loss of demand for our
products. Delays or quality lapses in our outsourced production lines
could result in substantial economic losses to us. Although we believe
that our continued focus on quality throughout the Company adequately addresses
these risks, there can be no assurance that we will not experience occasional or
systemic quality lapses in our outsourced manufacturing and service operations.
We have limited manufacturing capabilities, and if our manufacturing
capabilities are insufficient to produce an adequate supply of products at
appropriate quality levels, our growth could be limited and our business could
be harmed. If we experience significant or prolonged quality problems, our
business and reputation may be harmed, which may result in the loss of
customers, our inability to participate in future customer product opportunities
and reduced revenue and earnings.
We depend on our key management
personnel and the loss of their services could adversely affect our
business.
We place
substantial reliance upon the efforts and abilities of our executive officers,
Kathleen Karloff and Claude Ranoux. The loss of the services of our
executive officers could have a material adverse effect on our business,
operations, revenues or prospects. We do not maintain key man life
insurance on the lives of these individuals.
Currency
exchange fluctuations may affect the results of our operations.
We intend
to distribute our INVOcell product throughout the world. We intend to
transact our international sales in U.S. dollars, and European, Latin American
and Asian currencies. Our results of operations thus will be affected
by fluctuations in currency exchange rates. Although we may in the
future enter into foreign currency exchange forward contracts from time to time
to reduce our risk related to currency exchange fluctuation, our results of
operations might still be impacted by foreign currency exchange
rates. Because we do not anticipate that we will hedge against all of
our foreign currency exposure, our business will continue to be susceptible to
foreign currency fluctuations.
We
are subject to risks in connection with changes in international, national and
local economic and market conditions because of global
developments.
Our
business is subject to risks in connection with changes in international,
national and local economic and market conditions because of global
developments. Beyond the risks of doing business internationally, there is
also the potential impact of changes in the international, national and local
economic and market conditions as a result of global developments, including the
effects of global financial crisis, effects of terrorist acts and war on
terrorism, U.S. and Canadian presence in Iraq and Afghanistan, potential
conflict or crisis in North Korea or Middle East and current global credit
crisis, negatively affecting infertile couples’ ability to pay for fertility
treatment around the world.
International
sales are expected to account for a significant part of our revenue especially
in the ensuing period before we obtain FDA clearance, if ever. We
will experience additional risks associated with these sales
including:
|
•
|
political
and economic instability;
|
|
•
|
export
controls;
|
|
•
|
changes
in legal and regulatory requirements;
|
|
•
|
United
States and foreign government policy changes affecting the markets for our
products; and
|
|
•
|
changes
in tax laws and tariffs.
|
Any of
these factors could have a material adverse effect on our business, results of
operations and financial condition. We sell our products in certain
international markets mainly through independent distributors. If a
distributor fails to meet annual sales goals, it may be difficult and costly to
locate an acceptable substitute distributor. If a change in our
distributors becomes necessary, we may experience increased costs, as well as a
substantial disruption in operations and a resulting loss of
revenue.
We
are subject to significant regulation by the government and other regulatory
authorities.
Our
business is heavily regulated in the United States and internationally. In
addition to the FDA, various other federal, state and local regulations also
apply. If we fail to comply with FDA or other regulatory requirements, we
could be subjected to civil and criminal penalties, or even required to suspend
or cease operations. Any such actions could severely curtail our
sales. In addition, more restrictive laws, regulations or interpretations
could be adopted, which could make compliance more difficult or expensive or
otherwise adversely affect our business. We devote substantial resources
to complying with laws and regulations; however, the possibility cannot be
eliminated that interpretations of existing laws and regulations will result in
findings that we have not complied with significant existing regulations.
Such a finding could materially harm our business. Moreover,
healthcare reform is continually under consideration by regulators, and we do
not know how laws and regulations will change in the future.
Changes
in the healthcare industry may require us to decrease the selling price for our
products or could result in a reduction in the size of the market for our
products, each of which could have a negative impact on our financial
performance.
Trends in
managed care, healthcare cost containment and other changes in government and
private sector initiatives in the U.S. and other countries in which we do
business could place increased emphasis on the delivery of more cost-effective
medical therapies, which could work in our favor unless more cost-effective
devices become available, which could adversely affect the sale and/or the
prices of our products. There are proposed and existing laws and
regulations in domestic and international markets regulating pricing and
profitability of companies in the healthcare industry. There have
been initiatives by third-party payers to challenge the prices charged for
medical products, which could affect our ability to sell products on a
competitive basis in the future. There has been a consolidation among
healthcare facilities and purchasers of medical devices in the U.S. who prefer
to limit the number of suppliers from whom they purchase medical products, and
these entities may decide to stop purchasing our products or demand discounts on
our prices. Both the pressure to reduce prices for our products in
response to these trends and the decrease in the size of the market because of
these trends could adversely affect our levels of revenues and profitability of
sales, which could have a material adverse effect on our business.
We
are subject to the reporting requirements of U.S. federal securities laws, which
can be expensive.
We are
subject to the information and reporting requirements of the Exchange Act and
other federal securities laws, including compliance with the Sarbanes-Oxley Act.
The costs of preparing and filing annual and quarterly reports, proxy
statements and other information with the SEC and furnishing audited financial
statements to stockholders will cause our expenses to be higher than they would
be if we had remained privately-held. In addition, it may be time
consuming, difficult and costly for us to develop and implement the internal
controls and reporting procedures required by the Sarbanes-Oxley Act.
We may need to hire additional financial reporting, internal
controls and other finance personnel in order to develop and implement
appropriate internal controls and reporting procedures. If we are unable
to comply with the internal controls requirements of the Sarbanes-Oxley Act, we
may not be able to obtain the independent accountant certifications required by
the Sarbanes-Oxley Act.
Public
company compliance may make it more difficult to attract and retain officers and
directors.
The
Sarbanes-Oxley Act and new rules subsequently implemented by the SEC have
required changes in corporate governance practices of public companies. As
a public entity, we expect these rules and regulations to increase compliance
costs and to make certain activities more time consuming and costly. As a
public entity, we also expect that these new rules and regulations may make it
more difficult and expensive for us to obtain director and officer liability
insurance in the future and it may be required to accept reduced policy limits
and coverage or incur substantially higher costs to obtain the same or similar
coverage. As a result, it may be more difficult for us to attract and
retain qualified persons to serve as directors or as executive
officers.
Risks
Related to the REF and our common stock
We
are registering an aggregate of 8,790,000 shares of common stock to be issued
under the REF. The sale of such shares could depress the market price of our
common stock.
We are
registering an aggregate of 8,790,000 shares of common stock under the
registration statement of which this prospectus forms a part for issuance
pursuant to the REF. The sale of these shares into the public market by AGS
could depress the market price of our common stock. As of September 30,
2009, there were 55,247,833 shares of our common stock issued and
outstanding.
Assuming
we are able to utilize the maximum amount available under the REF, existing
shareholders could experience substantial dilution upon the issuance of common
stock.
Our REF
contemplates the potential future issuance and sale of up to $10 million of our
common stock to AGS subject to certain conditions and limitations. The following
table is an example of the number of shares that could be issued at various
prices assuming we utilize the maximum amount available under the
REF. These examples assume issuances at a market price of $0.33 per share
and at 5%,10%, 25% and 50% below the discounted $0.30 per share. The
following table should be read in conjunction with the footnotes immediately
following the table.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent below market price as of
12/11/09
|
|
|
Price per share
(1)
|
|
|
Number of shares
issuable
(2)
|
|
|
Shares
outstanding
(3)
|
|
|
Percent
of
outstanding
shares
(4)
|
|
|
5
|
%
|
|
|
.288
|
|
|
|
34,671,659
|
|
|
|
92,674,422
|
|
|
|
37
|
%
|
|
10
|
%
|
|
|
.273
|
|
|
|
36,597,863
|
|
|
|
94,600,626
|
|
|
|
39
|
%
|
|
25
|
%
|
|
|
.228
|
|
|
|
43,917,435
|
|
|
|
101,920,198
|
|
|
|
43
|
%
|
|
50
|
%
|
|
|
.152
|
|
|
|
65,876,153
|
|
|
|
123,878,916
|
|
|
|
53
|
%
|
(1)
|
Represents
purchase prices equal to 92% of $0.33 and potential reductions thereof of
5%, 10%, 25% and 50%.
|
(2)
|
Represents
the number of shares issuable if the entire $10 million under the REF were
drawn down at the indicated purchase prices.
|
(3)
|
Based
on 58,002,763 shares of common stock outstanding at December 11,
2009.
|
(4)
|
Percentage
of the total outstanding shares of common stock after the issuance of the
shares indicated, without considering any contractual restriction on the
number of shares the selling shareholder may own at any point in time or
other restrictions on the number of shares we may
issue.
|
We
may not have access to the full amount under the REF
.
The REF
provides that the dollar value that we will be permitted to raise from AGS
(subject to the conditions and limitations described elsewhere in this
prospectus) for each draw down will be 100% of the average daily volume on the
OTC Bulletin Board for the five trading days prior to the notice of Advance,
multiplied by the average of the five-day VWAP subsequent to the date of our
election to sell shares to AGS. During the nine months ended
September 30, 2009, the average market price of our common stock was $0.64 and
the average trading volume per day was 127,000. There is no assurance that the
market price and/or trading volume of our common stock will be maintained or
will increase substantially in the near future. Assuming we will
maintain the market price of our common stock at $0.33, after the 8% discount we
will need to issue 32,938,076 shares of common stock to AGS in order to have
access to the full amount under the REF.
AGS
will pay less than the then-prevailing market price for our common
stock.
The
common stock to be issued to AGS pursuant to the REF will be purchased at an 8%
discount to the VWAP of the common stock during the five consecutive trading
days immediately following the date of our notice to AGS of our election to sell
shares pursuant to the REF. AGS has a financial incentive to sell our common
stock immediately upon receiving the shares to realize the profit equal to the
difference between the discounted price and the market price. If AGS sells the
shares, the price of our common stock could decrease. If our stock price
decreases, AGS may have a further incentive to sell the shares of our common
stock that it holds. These sales may put further downward pressure on our
stock
price.
Our
shares of common stock are very thinly traded, and the price may not reflect our
value; there can be no assurance that there will be an active market for our
shares now or in the future.
We have a
trading symbol for our common stock ("IVOB”), which permits our shares to be
quoted on the OTC Bulletin Board, which is a quotation medium for subscribing
members, not an issuer listing service. However, our shares of common
stock are very thinly traded, and the price, if traded, may not reflect our
value. There can be no assurance that there will be an active market
for our shares of common stock either now or in the future. The
market liquidity will be dependent on the perception of our operating business
and any steps that our management might take to bring us to the awareness of
investors. There can be no assurances that there will be any
awareness generated. Consequently, investors may not be able to
liquidate their investment or liquidate it at a price that reflects the value of
the business. If a more active market should develop, the price may
be highly volatile. Because there may be a low price for our shares
of common stock, many brokerage firms may not be willing to effect transactions
in our securities. Even if an investor finds a broker willing to
effect a transaction in the shares of our common stock, the combination of
brokerage commissions, transfer fees, taxes, if any, and any other selling costs
may exceed the selling price. Further, many lending institutions will
not permit the use of such shares of common stock as collateral for any
loans.
The
market for penny stocks has experienced numerous frauds and abuses, which could
adversely affect investors in our stock.
We
believe that the market for penny stocks has suffered from patterns of fraud and
abuse. Such patterns include:
o
|
control
of the market for the security by one or a few
broker-dealers;
|
o
|
manipulation
of prices through prearranged matching of purchases and sales and false
and misleading statements made by parties unrelated to the
issuer;
|
o
|
“boiler
room" practices involving high pressure sales tactics and unrealistic
price projections by inexperienced sales
persons;
|
o
|
excessive
and undisclosed bid-ask differentials and markups by selling
broker-dealers; and
|
o
|
wholesale
dumping of the same securities by promoters and broker-dealers after
prices have been manipulated to a desired level, along with the inevitable
collapse of those prices with consequent investor
losses.
|
We
believe that many of these abuses have occurred with respect to the promotion of
low price stock companies that lacked experienced management, adequate financial
resources, an adequate business plan and/or marketable and successful business
or product.
Our
controlling stockholders may take actions that conflict with your
interests.
Certain
of our officers and directors beneficially own approximately 54.1% of our
outstanding common stock as of the date hereof. Our officers and directors
will be able to exercise control over all matters requiring stockholder
approval, including the election of directors, amendment of our certificate of
incorporation and approval of significant corporate transactions, and they will
have significant control over our management and policies. The
directors elected by these stockholders will be able to influence decisions
affecting our capital structure significantly. This control may have
the effect of delaying or preventing changes in control or changes in
management, or limiting the ability of our other stockholders to approve
transactions that they may deem to be in their best interest. For
example, our controlling stockholders will be able to control the sale or other
disposition of our operating businesses and subsidiaries to another
entity.
The
market price for our common stock is particularly volatile given our status as a
relatively unknown company with a small and thinly traded public float, limited
operating history and lack of revenues, which could lead to wide fluctuations in
our share price. The price at which you purchase our common stock may
not be indicative of the price that will prevail in the trading
market.
The
market for our common stock is characterized by significant price volatility
when compared to seasoned issuers, and we expect that our share price will
continue to be more volatile than a seasoned issuer for the indefinite
future. In fact, during the period from January 1, 2009 until
September 30, 2009, the high and low sale prices of a share of our common stock
were $0.05 and $5.50, respectively. The volatility in our share price is
attributable to a number of factors. First, as noted above, the
shares of our common stock are sporadically and/or thinly traded. As
a consequence of this lack of liquidity, the trading of relatively small
quantities of shares by our shareholders may disproportionately influence the
price of those shares in either direction. The price for our shares
could, for example, decline precipitously in the event that a large number of
shares of our common stock are sold on the market without commensurate demand,
as compared to a seasoned issuer which could better absorb those sales without
adverse impact on its share price.
Secondly,
we are a speculative or “risky” investment due to our limited operating history
and lack of meaningful revenues and profits to date, and uncertainty of future
market acceptance for our products and services. As a consequence of
this enhanced risk, more risk-adverse investors may, under the fear of losing
all or most of their investment in the event of negative news or lack of
progress, be more inclined to sell their shares on the market more quickly and
at greater discounts than would be the case with the stock of a seasoned
issuer.
You
may be unable to sell your common stock at or above your purchase price, which
may result in substantial losses to you.
The
following factors may add to the volatility in the price of our common stock:
uncertainty regarding the amount and price of sales of our common stock to AGS
under the REF; actual or anticipated variations in our quarterly or annual
operating results; government regulations, announcements of significant
acquisitions, strategic partnerships or joint ventures; our capital commitments;
and additions or departures of our key personnel. Many of these
factors are beyond our control and may decrease the market price of our common
stock, regardless of our operating performance. We cannot make any
predictions or projections as to what the prevailing market price for our common
stock will be at any time, including as to whether our common stock will sustain
its current market price, or as to what effect that the sale of shares or the
availability of common stock for sale at any time will have on the prevailing
market price.
Shares
eligible for future sale by our current shareholders may adversely affect our
stock price.
To date,
we have had a limited trading volume in our common stock. As long as
this condition continues, the sale of a significant number of shares of common
stock at any particular time could be difficult to achieve at the market prices
prevailing immediately before such shares are offered. In addition,
sales of substantial amounts of common stock, including shares issued upon the
exercise of outstanding options and warrants, under SEC Rule 144 or otherwise
could adversely affect the prevailing market price of our common stock and could
impair our ability to raise capital at that time through the sale of our
securities. On December 11, 2009, approximately 39,500,000 shares of
our common stock became subject to resale under Rule 144 as a result of the
expiration of the one-year period following our filing of the From 8-K reporting
our share exchange. Sales of a substantial number of such shares could adversely
affect our stock price.
We
entered into the REF on October 28, 2009 with AGS. The perceived risk of
dilution from sales of our common stock to or by AGS in connection with the REF
may cause holders of our common stock to sell their shares, or it may encourage
short selling by market participants, which could contribute to a decline in our
stock price. The registration rights agreement entered into in connection with
the REF requires that we use commercially reasonable efforts to ensure that the
registration statement in connection with the REF remains effective for the term
of such agreement. As of the date hereof, we have not drawn down
funds and have not issued shares of our common stock under our REF. Our ability
to draw down funds and sell shares under the REF requires the continued
effectiveness of and the ability to use the registration statement that we filed
registering the resale of any shares issuable to AGS under the REF.
Our
directors have the right to authorize the issuance of shares of our preferred
stock and additional shares of our common stock.
Our
directors, within the limitations and restrictions contained in our Articles of
Incorporation and without further action by our shareholders, have the authority
to issue shares of preferred stock from time to time in one or more series and
to fix the number of shares and the relative rights, conversion rights, voting
rights, and terms of redemption, liquidation preferences and any other
preferences, special rights and qualifications of any such
series. While we have no intention of issuing shares of preferred
stock at the present time, we continue to seek to raise capital through the sale
of our securities and may issue shares of preferred stock in connection with a
particular investment. Any issuance of shares of preferred stock
could adversely affect the rights of holders of our common stock.
Should we
issue additional shares of our common stock at a later time, each investor’s
ownership interest in our stock would be proportionally reduced. No
investor will have any preemptive right to acquire additional shares of our
common stock, or any of our other securities.
If
we fail to remain current on our reporting requirements, we could be removed
from the OTC Bulletin Board, which would limit the ability of broker-dealers to
sell our securities and the ability of shareholders to sell their securities in
the secondary market.
Companies
trading on the OTC Bulletin Board, such as INVO Bioscience, must be reporting
issuers under Sections 13 or 15(d) of the Exchange Act, and must be current in
their reports under Section 13 of the Exchange Act, in order to maintain price
quotation privileges on the OTC Bulletin Board. If we fail to remain
current on our reporting requirements, we could be removed from the OTC Bulletin
Board. As a result, the market liquidity for our securities could be
adversely affected by limiting the ability of broker-dealers to sell our
securities and the ability of shareholders to sell their securities in the
secondary market.
Our
common stock is subject to the “penny stock” rules of the SEC, and the trading
market in our common stock is limited, which makes transactions in our stock
cumbersome and may reduce the investment value of our stock.
Our
shares of common stock are “penny stocks” because they are not registered on a
national securities exchange or listed on an automated quotation system
sponsored by a registered national securities association, pursuant to Rule
3a51-1(a) under the Exchange Act. For any transaction involving a
penny stock, unless exempt, the rules require, among other things:
o
|
That
a broker or dealer approve a person’s account for transactions in penny
stocks;
|
o
|
That
the broker or dealer receives from the investor a written agreement to the
transaction, setting forth the identity and quantity of the penny stock to
be purchased;
|
o
|
The
broker or dealer must also deliver, prior to any transaction in a penny
stock, a disclosure schedule prescribed by the SEC relating to the penny
stock market, which, in highlight form, sets forth the basis on which the
broker or dealer made the suitability determination;
and
|
Generally,
brokers may be less willing to execute transactions in securities subject to the
“penny stock” rules. This may make it more difficult for investors to
dispose of our common stock and cause a decline in the market value of our
stock.
Disclosure
also has to be made about the risks of investing in penny stocks in both public
offerings and in secondary trading and about the commissions payable to both the
broker-dealer and the registered representative, current quotations for the
securities and the rights and remedies available to an investor in cases of
fraud in penny stock transactions. Finally, monthly statements have
to be sent disclosing recent price information for the penny stock held in the
account and information on the limited market in penny stocks.
SPEC
IAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This
prospectus includes forward-looking statements. All statements, other
than statements of historical fact, contained in this prospectus constitute
forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as “may,” “intend,” “might,” “will,”
“should,” “could,” “would,” “expect,” “believe,” “estimate,” “anticipate,”
“predict,” “project,” “potential,” or the negative of these terms and similar
expressions intended to identify forward-looking statements.
Forward-looking
statements are based on assumptions and estimates and are subject to risks and
uncertainties. We have identified in this prospectus some of the
factors that may cause actual results to differ materially from those expressed
or assumed in any of our forward-looking statements. There may be
other factors not so identified. You should not place undue reliance
on our forward-looking statements. As you read this prospectus, you
should understand that these statements are not guarantees of performance or
results. Further, any forward-looking statement speaks only as of the
date on which it is made and, except as required by law, we undertake no
obligation to update any forward-looking statement to reflect events or
circumstances after the date on which it is made or to reflect the occurrence of
anticipated events or circumstances. New factors emerge from time to
time that may cause our business not to develop as we expect and it is not
possible for us to predict all of them. Factors that may cause actual
results to differ materially from those expressed or implied by our
forward-looking statements include, but are not limited to, those described
under the heading “Risk Factors” beginning on page 6.
We will
not receive any proceeds from the sale of common stock offered by AGS pursuant
to this prospectus. However, we will receive proceeds from the sale of our
common stock to AGS pursuant to the REF. The proceeds from our rights to sell
shares pursuant to the REF will be used for working capital and general
corporate expenses.
We
propose to expend these proceeds as follows:
|
|
Proceeds
if 100%, or 8,790,000 shares, are sold
At
an assumed price of $0.304
|
|
|
Proceeds
if 50% of 8,790,000 shares sold
|
|
Gross
proceeds
|
|
$
|
2,669,000
|
|
|
$
|
1,334,500
|
|
Offering
expenses:
|
|
|
|
|
|
|
|
|
Legal
fees
|
|
|
30,000
|
|
|
|
30,000
|
|
Accounting
and auditing fees
|
|
|
10,000
|
|
|
|
10,000
|
|
State
securities fees
|
|
|
2,000
|
|
|
|
2,000
|
|
Transfer
agent fees
|
|
|
10,000
|
|
|
|
10,000
|
|
Broker’s
fees
|
|
|
160,100
|
|
|
|
80,100
|
|
|
|
|
|
|
|
|
|
|
Miscellaneous
expenses
|
|
|
5,000
|
|
|
|
5,000
|
|
Total
offering expenses
|
|
|
217,100
|
|
|
|
137,100
|
|
Net
proceeds
|
|
$
|
2,451,900
|
|
|
$
|
1,197,400
|
|
We expect
to use the net proceeds, if any, from sales of our common stock to AGS under the
REF for working capital needs, including paying accounts payable, notes payable,
inventory, FDA medical device clinical trials, as well as accrued but unpaid
salaries of our employees. The amounts and timing of the expenditures
will depend on numerous factors, such as the timing and progress of our clinical
trial for FDA approval and the competitive environment. As of the date of this
prospectus, we cannot specify with certainty all of the particular uses for the
net proceeds to us from the sale of shares to AGS. Accordingly, we will retain
broad discretion over the use of proceeds.
MARKET FOR
COMMON EQUITY AND RELATED SHAREHOLDER
MATTERS
Our
common stock has been traded on the OTC Bulletin Board since February 17, 2009
under the symbol "IVOB". Prior to that date, our common stock was
traded under the symbol of “EMYS” in the public market on the OTC Bulletin Board
as well. The following table sets forth, for the periods indicated,
the high and low bid prices for our common stock on the OTC Bulletin Board. The
quotations do not reflect adjustments for retail mark-ups, mark-downs, or
commissions and may not necessarily reflect actual transactions.
|
|
Price
|
|
|
High
|
|
|
Low
|
2009
|
|
|
|
|
|
|
|
First
Quarter
|
$
|
5.50
|
|
|
$
|
0.40
|
|
Second
Quarter
|
$
|
1.01
|
|
|
$
|
0.05
|
|
Third
Quarter
|
$
|
0.46
|
|
|
$
|
0.08
|
|
On
December 11, 2009 the high and low bid prices of our common stock on the OTC
Bulletin Board were $0.33 and $0.31 per share, respectively, and there were
approximately 98 holders of record of our common stock with 58,002,763 shares
issued and outstanding.
To date,
we have never declared or paid any cash dividends on our capital
stock. We currently intend to retain any future earnings for funding
growth and therefore, do not expect to pay any dividends in the foreseeable
future.
The
following table sets forth our capitalization as of September 30,
2009:
·
|
on
an actual basis; and
|
·
|
as
adjusted to reflect the sale of 8,790,000 shares of common stock offered
by this prospectus, at an assumed initial price of $0.304 per share, after
deducting estimated offering expenses payable by
us.
|
This
information should be read in conjunction with our Management’s Discussion and
Analysis or Plan of Operation and our consolidated financial statements and the
related notes appearing elsewhere in this prospectus.
We had a
net loss of ($4,499,000) for the nine months ended September 30, 2009 and a
total net loss of $6,586,000 from January 5, 2007, (inception) through September
30, 2009, included in the accumulated deficit in the table below:
|
|
September
30, 2009
|
|
|
|
|
|
Actual
|
|
|
Adjusted
|
|
|
|
Capitalization:
|
|
|
|
|
|
|
|
|
Preferred
Stock, $.0001 par value; 100,000,000 shares authorized; no shares issued
and outstanding
|
|
|
-
|
|
|
|
-
|
|
|
|
Common
Stock, $0.0001 par value; 200,000,000 share authorized; 55,247,833 issued
and
outstanding and 66,792,763(1) issued and outstanding as
adjusted.
|
|
$
|
2,213,878
|
|
|
$
|
4,665,768
|
|
(1)
|
|
Stock
subscription receivable
|
|
|
(205,000
|
)
|
|
|
(205,000
|
)
|
|
|
Accumulated
deficit during the development stage
|
|
|
(6,586,312
|
)
|
|
|
(6,586,312
|
)
|
|
|
Total Capitalization
|
|
$
|
(4,577,434
|
)
|
|
$
|
(2,125,544
|
)
|
|
|
(1) Reflects
the sale of the 8,790,000 shares included in this prospectus, at a price of
$0.304 per share.
The
following consolidated selected financial data as of December 31, 2008 and for
the years ended December 31, 2008 and 2007 are derived from our consolidated
financial statements. The following selected financial data as of September 30,
2009 is derived from unaudited financial statements that, in our opinion,
reflect all adjustments (consisting of normal recurring adjustments) necessary
for a fair presentation of the financial position as of such date and results of
operations for these periods. Operating results for the nine-month
period ended September 30, 2009 are not necessarily indicative of the results
that may be expected for the entire year ending December 31, 2009. The data set
forth below should be read in conjunction with our financial statements and
notes thereto included elsewhere in this prospectus and with “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.”
|
|
For
the Nine
|
|
|
Year
|
|
|
From
January 5, 2007
|
|
|
|
Months
Ended
|
|
|
Ended
|
|
|
(Inception)
to
|
|
|
|
September 30,
2009
|
|
|
December 31,
2008
|
|
|
December 31,
2007
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product
Revenue
|
|
$
|
56,298
|
|
|
$
|
37,955
|
|
|
$
|
-
|
|
Cost
of Goods Sold:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Costs
|
|
|
30,528
|
|
|
|
10,088
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Margin:
|
|
|
25,770
|
|
|
|
27,907
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
4,950
|
|
|
|
51,761
|
|
|
|
33,350
|
|
Selling,
general and administrative
|
|
|
1,394,592
|
|
|
|
1,837,606
|
|
|
|
77,170
|
|
Total
Operating Expenses
|
|
|
1,399,542
|
|
|
|
1,889,367
|
|
|
|
210,520
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(1,373,772
|
)
|
|
|
(1,861,460
|
)
|
|
|
(210,520
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in
fair value of derivative liability
|
|
|
380,036
|
|
|
|
-
|
|
|
|
-
|
|
Interest and financing expenses
|
|
|
2,745,010
|
|
|
|
11,945
|
|
|
|
3,569
|
|
Total
other expenses
|
|
|
3,125,046
|
|
|
|
11,945
|
|
|
|
3,569
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before income taxes
|
|
|
(4,498,818
|
)
|
|
|
(1,873,405
|
)
|
|
|
(214,089
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provisions
for income taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(4,498,818
|
)
|
|
$
|
(1,873,405
|
)
|
|
$
|
(214,089
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per weighted average shares of common
stock
|
|
$
|
(0.08
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
(0.01)
|
|
Basic
and diluted Weighted average number of shares of common
stock
|
|
|
53,849,481
|
|
|
|
36,691,176
|
|
|
|
24,649,031
|
|
The
following discussion of our financial condition and results of operations should
be read in conjunction with the financial statements and the notes to those
statements included in this prospectus. This discussion includes forward-looking
statements that involve risk and uncertainties. As a result of many factors,
such as those set forth in this prospectus under “Risk Factors,” actual results
may differ materially from those anticipated in these forward-looking
statements.
Overview
We are a
development stage company that has recently begun to commercialize our proven
and patented technology that we believe will revolutionize the treatment of
infertility. Our device, the INVOcell, and the INVO procedure are
designed to provide an alternative infertility treatment for the patient and the
clinician; it is less expensive and simpler to perform than current infertility
treatments. The simplicity of the INVO procedure relates to the
ability to potentially perform the infertility procedure in a physician’s
practice rather than in a specialized facility at a much lower cost overall than
current infertility treatments, including in vitro fertilization (“
IVF
”). Therefore,
we believe that the INVO procedure will be available in many more locations than
conventional IVF especially outside the United States. INVO also
allows conception and embryo development to take place inside the woman's body;
an attractive feature for most couples.
Our
primary focus is the sale of the INVOcell device and the INVO technology to
assist infertile couples in having a baby. Our patented and proven
INVOcell technology is an effective low cost alternative to current
treatments. Along with being offered as an option in traditional IVF
clinics, the INVO technique may be provided in a physician’s office or a
small lab and, therefore, may be offered by physicians around the world to
couples who do not have access to IVF facilities. INVO uses a device,
the INVOcell, which we currently sell to distributors around the world (outside
of the U.S.) at prices ranging from $75 to $400. Currently, we are
only authorized to sell the INVOcell device in certain international markets. We
do not expect to be able to sell the device in the United States until the first
quarter of 2011, assuming we receive the necessary capital to complete our
clinical trial and receive FDA clearance by such date. We are
establishing agreements with distributors and beginning to train physicians
around the world in places such as South America, Europe, Africa and the Middle
East. While we penetrate the infertility markets in Europe and Canada
along with certain developing countries, we anticipate pursuing the completion
of the U.S. Federal Food and Drug Administration’s (“FDA”) “510(k)”
process. We have completed the first step for medical device
companies who manufacture Class 2 devices and the filing of a Premarket
Notification with the FDA (
i.e.,
an FDA 510(k)
submission). Technically, the FDA does not “approve” Class 1 and 2
medical devices for sale in the U.S. they give “clearance” for them to be
sold. We are hoping to receive clearance to market in the U.S.
by the end of 2010 upon completion of our clinical trial, which we will commence
sometime after the start of funding from our REF with AGS Capital Group,
LLC. However, there can be no assurance that we will receive such
clearance by that date or ever.
We
operate by outsourcing many key operational functions in the development and
manufacturing of the INVOcell device to keep fixed costs to a
minimum. Our most critical management and leadership functions are
carried out by our core team. We have contracted out the following
functions: manufacturing, packaging/labeling and sterilization of the device to
a certified manufacturer to mold the parts; to a medical manufacturing company
to assemble packages and label the product and to a sterilization specialist to
perform the gamma sterilization process. This expedites production
and eliminates the need for in-house capital equipment
expenditures.
We
anticipate that we will experience significant quarterly fluctuations in our
sales and revenues as a result of our efforts to expand the sales of the INVO
technology to new markets. Operating results will depend upon and
upon the timing of signing of new distributor contracts and the training of
physicians and their staffs in the INVO procedure. International
sales will continue to be our only source of revenue for the coming
year. We are aware of many significant international opportunities,
and we expect international revenues to continue to
grow. International sales are, however, difficult to forecast.
Subject to having available financial resources, we are committed in our ongoing
sales, marketing and development activities to sustain and grow our sales and
revenues from our products and services.
During
the last year, we continued to market our products in strategic markets
utilizing our limited resources in the most economical fashion possible. We
focused our efforts on South America and parts of Europe as we see these as our
best opportunities to introduce the INVO procedure to many willing physicians
quickly. During this period, we reduced our travel and planned trips
further in advance to benefit from travel discounts, which reduced our travel
expenses considerably. We had a presence at the World Congress of
Gynecology and Obstetrics held in Cairo, Egypt in October 2009, as we continued
to introduce the INVOcell across new regions of the Middle East and
Africa. This annual meeting is the largest infertility conference of
physicians in Northern Africa and was felt to be an essential component in
gaining name recognition and traction in this part of the world.
The
INVOcell is cleared for use within a particular country by its CE mark, but
still must undergo a registration process in certain countries because it is a
Class II medical device. In some countries, the process is relatively
quick - approximately three to six weeks - while we have discovered in other
countries it may take months. While we are continuing to tend to the
needs of the regional health organizations for registering the INVOcell, INVO
Bioscience has continued to actively train physicians and teach distributors in
the INVOcell technology. Physicians have demonstrated that their
patients would like to see current success rates within their own geographic and
cultural areas and therefore we are assisting them in sponsoring clinical
marketing trials. As of September 30, 2009, we have the necessary approvals to
sell the INVOcell device in the following countries: Canada, Colombia,
Guatemala,
Belgium,
Greece, Bulgaria, Turkey, Poland, Spain, Switzerland, Cyprus, Pakistan,
Cameroon, Nigeria, South Africa and India
.
We have started the
registration process in the following countries as well: Peru, Argentina,
Venezuela, Egypt, Russia and Taiwan,
Because
of the registration process and delays to wait for “local results” in certain
geographic and cultural areas, along with limited resources to assist in moving
things forward in some countries, revenues were significantly less than
anticipated for the quarter. However, we are starting to receive
registration notifications as well as receiving favorable initial local results
that will be used for regional marketing campaigns. In addition
to these developments, we are continuing to plan sales and training trips
actively. We believe that we will begin increasing revenues in the
future; however, our growth is limited by both the registration processes that
we must undertake as well as our limited capital resources, and therefore we
anticipate that revenues will continue to be lower than originally anticipated
for the next few quarters. The registration process differs from a
clinical approval, which the INVOcell has in the form of the CE mark; instead,
the process is more akin to a governmental tracking to monitor what products are
sold and used within its borders.
Our most
significant challenge in growing our business has been our limited
resources. As of September 30, 2009, we generally require
approximately $175,000 per month to fund our planned operations. This
amount may increase as we expand our sales and marketing efforts and develop new
products and services; however, if we do not raise additional capital in the
near future we will have to curtail our spending and downsize our
operations. Our cash needs are primarily attributable to funding our
clinical trial, sales and marketing efforts, strengthening our training
capabilities, satisfying existing obligations and building an administrative
infrastructure, including costs and professional fees associated with being a
public company.
We
believe we are taking the necessary steps to provide the capital resources we
need to execute our business plan and grow the business as expected, including
through the REF with AGS Capital Group, LLC, although no assurances can be made
that we will be able to draw down on the REF. We also seek other
sources of capital through private placements of our securities. The exact
amount of funds raised, if any, will determine how aggressively we can grow and
what additional projects we will be able to undertake, such as initiating the
final required FDA clinical trial. No assurance can be given that we
will be able to raise additional capital when needed. If we are
unable to raise additional capital, we will be required to substantially curtail
or cease operations.
Our
registered independent certified public accountants have stated in their report
dated April 15, 2009, filed with the Company’s Annual Report on Form 10-K that
we have a generated negative cash outflows from operating activities,
experienced recurring net operating losses, and we are dependent on securing
additional equity and debt financing to support our business
efforts. These factors among others raise substantial doubt about our
ability to continue as a going concern.
Results of
Operations
Nine
months ended September 30, 2009, compared to the nine months ended September 30,
2008
Net Sales and
Revenues
Net sales
and revenue for the nine months ending September 30, 2009 were $56,300
compared to no revenue for the same period in 2008. The increase was
due to starting international shipments of small orders to our newly signed
distributors as well as direct shipments to physicians who want to use the
INVOcell. We expect this trend to continue as we introduce the INVO
technology into our targeted countries over the next few months while continuing
to assist our current customer base in the Mid-East and South America. As
noted above, our ability to generate revenues is also impacted by our ability to
obtain appropriate approvals/registrations in local jurisdictions, as well as
our success in raising additional capital to fund sales and marketing
efforts.
Cost of Sales and
Revenues
Cost of
sales as a percentage of revenues for the nine months ended September 30, 2009
was 54%. This is significantly higher than we expect in the future as we
are producing small lot quantities and have higher shipping costs per unit as a
result of the small volume shipments. There were no sales or costs for the
comparative period of 2008 with which to compare our results. As our
products become an accepted method of assisting couples with infertility and
subject to raising additional capital, we expect to be manufacturing larger
quantities of our devices, which in we expect will reduce our cost of
sales. Further, shipping larger quantities to distributors via common
carriers will reduce our shipping costs. Collectively, we anticipate
that eventually these volume discounts would reduce our cost of sales by
approximately 50%, or approximately 25% of revenues.
Selling, General and
Administrative Expenses
Selling,
general and administrative expenses for the nine months ended September 30, 2009
and 2008 were $1,395,000 and $661,000, respectively. Our higher general
and administrative expenses in 2009 were due to expanding the marketing of our
products and technology across the world outside of the United
States. During the initial six months of 2008, we had three senior
employees who did not take a salary. In 2009, we grew to six
employees, all earning a salary as well as all the associated expenses that
relate to them, including benefits and travel. Salaries and benefits for
the period were $680,000 compared to $375,000 for the same period ending
September 30, 2008. We incurred considerable travel costs as our
employees continued to travel internationally to introduce the INVOcell and the
INVO process to physicians and distributors in Europe, Mid-East, Asia and South
America. Travel related expenses for the nine months ending September 30, 2009
were $131,000 compared to $32,000 in the same period in 2008. We
continued to protect our patent rights around the world with legal and filing
fees totaling $31,000 for the nine months ended September 30, 2009 compared to
$23,000 for the nine months ended September 30, 2008. Some
of the new expenses incurred by us during the nine months ended
September 30, 2009 relate to being a public entity, including investor
relations, insurance, accounting and legal costs, which together were
$242,000 versus $77,000 for the nine months ended September 30,
2008.
Research and Development
Expenses
Research
and development expenses increased to $5,000 for the nine months ended September
30, 2009, as compared to $0 spent in the nine months ended September 30,
2008. The increase in research and development expense was for a new
product model. We do not anticipate much spending in R&D in the
next 6-12 months as we focus our resources on launching and training doctors on
our current products.
Interest Income and Expense
and Financing Fees
During
the nine-month period ended September 30, 2009, we incurred significant non-cash
financing liability expense related to the convertible loans with detachable
warrants that we issued to raise capital during the period. We
incurred $3,100,000 in non-cash expense primarily from the common stock market
price appreciation compared to the conversion feature of $0.10 per share and
warrant price per share of $0.20. We had net interest expense of
$24,600 for the nine months ended September 30, 2009, as compared to $5,900 for
the nine months ended September 30, 2008 as a result of having higher loans
including the convertible loans in 2009 versus 2008.
Income
Taxes
Our
aggregate unused net operating losses approximate $3,400,000, which expire at
various times through 2029, subject to limitations of Section 382 of the
Internal Revenue Code of 1986, as amended. The deferred tax asset
related to the carry forward is approximately $540,000. We have
provided a valuation reserve against the full amount of the net operating loss
benefit, since in the opinion of management based upon our earnings history, it
is more likely than not that we will not realize the net operating loss
benefits.
Year
ended December 31, 2008 and December 31, 2007
Net Sales and
Revenues
Net sales
and revenues for 2008 increased 100% to $38,000 compared to no revenues in
2007. The increase was due to starting international shipments of
small orders to our newly signed distributors as well as direct shipments to
physicians who wanted to use the INVOcell.
Cost of Sales and
Revenues
Cost of
sales as a percentage of revenues was 27% for 2008 This is
slightly higher than we expect in the future as we are producing small lot
quantities and have higher shipping cost per unit as a result of the small
volume shipments. There were no sales or costs in 2007 to compare
to.
Selling, General and
Administrative Expenses
Selling,
general and administrative expenses were $1,837,600 in 2008 as compared to
$177,200 in 2007. We experienced higher general and administrative
costs in 2008 due to hiring our first employees and all the associated expenses
that relate to them, including benefits, a stock compensation charge for common
stock grants and travel, which costs totaled approximately
$1,070,000. During the year ended December 31, 2008, we also incurred
considerable travel costs as our employees started to travel internationally to
introduce the INVOcell and the INVO process to physicians and distributors in
Europe, the Mid-East, Asia and South America. Such travel related expenses
totaled $150,000 during 2008. We continued to protect our patent
rights throughout the world, resulting in legal and filing fees totaling $54,000
in 2008. Also, in December 2008, we completed our share exchange and
the accounting and legal costs in preparing for and completing that transaction
was approximately $375,000.
Research and Development
Expenses
Research
and development expenses increased to $51,800 in 2008 from $33,400 in
2007. The increase in research and development expense was a result
of our efforts to continually understand the regulations and guidelines for
selling the INVOcell in foreign countries.
Interest Income and Expense,
Net
We had
net interest expense of $11,900 in 2008 as compared to $3,600 in 2007 as a
result of having our loans for all of 2008 versus only part of
2007.
Income
Taxes
Our
aggregate unused net operating losses as of the end of 2008 approximated
$1,800,000 and expire at various times through 2028 and are subject to
limitations of Section 382 of the Internal Revenue Code, as
amended. The deferred tax asset related to the carry forward is
approximately $540,000. We have provided a valuation reserve against
the full amount of the net operating loss benefit, since in the opinion of
management based upon our earnings history, it is more likely than not that the
benefits will not be realized.
Liquidity and Capital
Resources
Our lack
of financial resources continues to be our major challenge. As of
September 30, 2009, we had $194,400 in cash and no cash
equivalents. Net cash used by operating activities was $673,000 for
the nine months ended September 30, 2009, compared to net cash used by operating
activities of $375,000 for the nine months ended September 30,
2008. The increase in net cash used was due to the significant costs
of staffing, compliance and introducing our products into new
markets. In addition, all of the current employees have assisted INVO
Bioscience in its funding requirements by deferring their salaries ($377,000, as
of September 30, 2009) for the last seven months ending September 30,
2009.
No cash
was used during the first nine months of 2009 in investing activities, compared
to $44,000 cash used by investing activities for the same period of
2008. The cash used during 2008 was for the purchase of patents to
protect our proprietary products. During 2009, we maintained our
current patents across the globe and currently do not believe it is necessary to
expand any of them at this time. Also during 2008, we purchased
manufacturing molds and a telephone system.
Net cash
provided by financing activities was $852,000 for the nine months ended
September 30, 2009. Of that amount, $88,000 was provided by a short term 5% loan
by Kathleen Karloff, our CEO. In addition, on September 15, 2009, we
completed a bridge offering of $545,000 principal amount of 10% convertible
notes (the “
Notes
”). Each
Note bears interest, payable in shares of common stock, at a rate equal to 9-12%
per annum from the date of issuance of the Note until paid in full on the
Maturity Date (defined below). The initial investor’s Notes have a 12% interest
rate. All outstanding principal and accrued interest under each Note is payable
on the first to occur of (i) one year following the original issue date (as
defined below), or (ii) a follow-on financing of at least $2,500,000 (the “
Maturity
Date
”). We can prepay the Notes at any time without penalty or
premium. The Notes are secured by all of our assets and carry detachable common
stock purchase warrants. The Notes rank junior to our SBA $50,000
Century Bank Line of Credit Loan and rank senior in all respects to all other
existing and future indebtedness. The Notes are convertible into our common
stock at a conversion price of $0.10 per share. The investors have the option to
convert all or any portion of the principal amount of the Notes outstanding at
any time, together with any accrued and unpaid interest hereunder into shares of
common stock at the conversion price. In addition, as additional
consideration for the investment in the Notes, we issued to the initial investor
in the Notes a warrant to purchase the number of shares of common stock
equal to 100% of the quotient of the principal amount of the Note issued to such
investor divided by the Conversion Price, as set forth in such Note, which
Conversion Price equals $0.10 per share and the exercise price of the Warrants
equals $0.20 per share. The purchase agreement for the Notes also
includes certain negative covenants of the company, including, without
limitation, limitations on: incurring additional indebtedness and
liens, transactions with affiliates and payment of dividends.
The
remaining $245,000 of net cash provided by financing activities was from
Lionshare Ventures, per a subscription receivable agreement dated December 5,
2008, and revised on June 10, 2009, for the previous sale of common stock to
Lionshare Ventures. As of September 30, 2009, $205,000 is still due
to us from Lionshare Ventures.
We
maintain a $50,000 working capital line of credit with Century
Bank. Interest is payable monthly at the rate of 0.24% above the
bank’s prime lending rate. As of September 30, 2009, the rate was
3.74%. This line of credit matures on May 31, 2010. At
September 30, 2009 and December 31, 2008, the balance outstanding on the line of
credit was $50,000.
Our
registered independent certified public accountants have stated in their report
dated April 15, 2009, that we have generated negative cash outflows from
operating activities, experienced recurring net operating losses, and are
dependent on securing additional equity and debt financing to support our
business efforts. These factors among others may raise substantial
doubt about our ability to continue as a going concern.
Our
existing cash resources, cash flow from operations and short-term borrowings on
the existing credit line or from management will not provide adequate resources
for supporting operations during fiscal 2009 and 2010. We are
actively seeking the funding we need to continue to execute our business
plan. We intend to achieve additional funding through additional
sales of our securities, including in connection with the $10 million REF
described elsewhere in this prospectus. Although there can be no
assurance that an additional source of funding will materialize, we currently
believe that we will be able to obtain the funding we need to continue to grow
our business. However, if we do not raise additional capital in the
near future we will have to further curtail our spending and downsize or cease
our operations.
Critical
Accounting Policies
The
preparation of financial statements and related disclosures in conformity with
accounting principles generally accepted in the United States requires us to
make judgments, assumptions and estimates that affect the amounts reported. Note
1 of Notes to Financial Statements describes the significant accounting policies
used in the preparation of the financial statements. Certain of these
significant accounting policies are considered to be critical accounting
policies, as defined below.
A
critical accounting policy is defined as one that is both material to the
presentation of our financial statements and requires management to make
difficult, subjective or complex judgments that could have a material effect on
our financial condition and results of operations. Specifically, critical
accounting estimates have the following attributes: 1) we are required to make
assumptions about matters that are highly uncertain at the time of the estimate;
and 2) different estimates we could reasonably have used, or changes in the
estimate that are reasonably likely to occur, would have a material effect on
our financial condition or results of operations.
Estimates
and assumptions about future events and their effects cannot be determined with
certainty. We base our estimates on historical experience and on various other
assumptions believed to be applicable and reasonable under the circumstances.
These estimates may change as new events occur, as additional information is
obtained and as our operating environment changes. These changes have
historically been minor and have been included in the consolidated financial
statements as soon as they became known. Based on a critical assessment of our
accounting policies and the underlying judgments and uncertainties affecting the
application of those policies, management believes that our financial statements
are fairly stated in accordance with accounting principles generally accepted in
the United States, and present a meaningful presentation of our financial
condition and results of operations.
In
preparing our financial statements to conform to accounting principles generally
accepted in the United States, we make estimates and assumptions that affect the
amounts reported in our financial statements and accompanying notes. These
estimates include useful lives for fixed assets for depreciation calculations
and assumptions for valuing options and warrants. Actual results could differ
from these estimates.
We are a
development stage company, as defined by Accounting Standards Codification
(“ASC”) Topic 915, “Accounting and Reporting by Development Stage Enterprise”
formerly (“SFAS”) No. 7. The Company’s activities during our
development stage to date has included developing the business plan, seeking
regulatory clearance in the European Union and the United States, raising
capital, conducting beta tests, sales and marketing of the INVOcell device and
offering instructions in the INVO technique to doctors in numerous foreign
countries.
Through
September 30, 2009, we have generated minimal sales revenues, have incurred
significant expenses and have sustained losses. Consequently, our
operations are subject to all of the risks inherent in the establishment of a
new business enterprise.
We
consider that the following are critical accounting policies:
Derivatives
—
In
June 2008, the FASB ratified EITF Issue No. 07-5, “Determining Whether
an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock” (EITF
07-5, included in ASC 815-40). EITF 07-5 mandates a two-step process for
evaluating whether an equity-linked financial instrument or embedded feature is
indexed to the entity’s own stock. It is effective for fiscal years beginning on
or after December 15, 2008. We recently adopted EITF 07-5 and
had a significant effect on our consolidated condensed financial
statements.
Fair Value Measurements
— On
January 1, 2008, we adopted FASB ASC 820-10, “Fair Value Measurements and
Disclosures.” FASB ASC 820-10 defines fair value, and establishes a three-level
valuation hierarchy for disclosures of fair value measurement that enhances
disclosure requirements for fair value measures. The carrying amounts reported
in the consolidated balance sheets for receivables and current liabilities each
qualify as financial instruments and are a reasonable estimate of their fair
values because of the short period of time between the origination of such
instruments and their expected realization and their current market rate of
interest. The three levels of valuation hierarchy are defined as
follows:
|
·
Level
1 inputs to the valuation methodology are quoted prices for identical
assets or liabilities in active
markets.
|
|
·
Level
2 inputs to the valuation methodology include quoted prices for similar
assets and liabilities in active markets, and inputs that are observable
for the asset or liability, either directly or indirectly, for
substantially the full term of the financial
instrument.
|
|
·
Level
3 inputs to the valuation methodology are unobservable and significant to
the fair value measurement.
|
Management
analyzes all financial instruments with features of both liabilities and equity
under FASB ASC 480, “Distinguishing Liabilities From Equity” and FASB ASC 815,
“Derivatives and Hedging.” Derivative liabilities are adjusted to reflect fair
value at each period end, with any increase or decrease in the fair value being
recorded in results of operations as adjustments to fair value of derivatives.
The effects of interactions between embedded derivatives are calculated and
accounted for in arriving at the overall fair value of the financial
instruments. In addition, the fair values of freestanding derivative instruments
such as warrant and option derivatives are valued using the Black-Scholes
model.
Stock Based Compensation
— We
account for stock-based compensation under the provisions of FASB ASC 718
“Compensation-Stock Compensation.” This statement requires us to
measure the cost of employee services received in exchange for an award of
equity instruments based on the grant-date fair value of the
award. That cost is recognized over the period in which the employee
is required to provide service in exchange for the award, which is usually the
vesting period.
Revenue Recognition
— We will
recognize revenue on arrangements in accordance with Securities and Exchange
Commission Staff Accounting Bulletin No. 101, “Revenue Recognition in Financial
Statements” and No. 104, “Revenue Recognition”. In all cases, revenue
is recognized only when the price is fixed and determinable, persuasive evidence
of an arrangement exists, the service is performed and collectability of the
resulting receivable is reasonably assured.
Recently
Issued Accounting Pronouncements
On
July 1, 2009, the Financial Accounting Standards Board (“FASB”) launched
the FASB Accounting Standards Codification (“ASC”) 105,
Generally Accepted Accounting
Principles
(“ASC 105” and formerly referred to as FAS 168). ASC 105,
establishes the FASB Accounting Standards Codification as the source of
authoritative accounting principles recognized by the FASB to be applied by
nongovernmental entities in the preparation of financial statements in
conformity with GAAP. Rules and interpretive releases of the Securities and
Exchange Commission (SEC) under authority of federal securities laws are also
sources of authoritative GAAP for SEC registrants. ASC 105 is effective for
financial statements issued for interim and annual periods ending after
September 15, 2009.
GAAP
is not intended to be changed as a result of the FASB’s Codification project,
but it will change the way the guidance is organized and presented. As a result,
these changes will have a significant impact on how companies reference GAAP in
their financial statements and in their accounting policies for financial
statements issued for interim and annual periods ending after September 15,
2009.
In
June 2009, the FASB issued SFAS No. 167,
Amendments to FASB Interpretation
No. 46(R)
(“SFAS 167”). SFAS 167, which amends ASC
810-10,
Consolidation
(“ASC
810-10”), prescribes a qualitative model for identifying whether a company has a
controlling financial interest in a variable interest entity (“VIE”) and
eliminates the quantitative model prescribed by ASC 810-10. The new
model identifies two primary characteristics of a controlling financial
interest: (1) provides a company with the power to direct significant
activities of the VIE, and (2) obligates a company to absorb losses of
and/or provides rights to receive benefits from the VIE. SFAS 167
requires a company to reassess on an ongoing basis whether it holds a
controlling financial interest in a VIE. A company that holds a
controlling financial interest is deemed to be the primary beneficiary of the
VIE and is required to consolidate the VIE. SFAS 167, which is
referenced in ASC 105-10-65, has not yet been adopted into the Codification and
remains authoritative. This statement is effective for fiscal years
beginning after November 15, 2009. We plan to adopt SFAS 167
effective January 1, 2010. The adoption of SFAS 167 is not
expected to have a material impact on our financial position and results of
operations.
In
June 2009, the FASB issued SFAS No. 166,
Accounting for Transfers of
Financial Assets
(“SFAS 166”). SFAS 166 removes the concept of
a qualifying special-purpose entity from ASC 860-10,
Transfers and
Servicing
(“ASC 860-10”), and removes the exception from applying ASC
810-10. This statement also clarifies the requirements for isolation
and limitations on portions of financial assets that are eligible for sale
accounting. SFAS 166, which is referenced in ASC 105-10-65, has not
yet been adopted into the Codification and remains
authoritative. This statement is effective for fiscal years beginning
after November 15, 2009. We plan to adopt SFAS 166 effective
January 1, 2010. The adoption of SFAS 166 is not expected to
have a material impact on our financial position and results of
operations.
COMPANY
BACKGROUND
INVO
Bioscience was formed in January 2007 under the laws of the Commonwealth of
Massachusetts under the name “Bio X Cell, Inc.,” which was the business
successor to Medelle Corporation (“Medelle”). Dr. Claude Ranoux was
the founder and vice president of Medelle and Kathleen Karloff was a vice
president of Medelle. Between 2001 and 2006, Medelle raised $8 million in
venture capital, which was used to develop and validate a device called the
“INVOcell.” Medelle conducted pre-clinical safety testing and
performed a human efficacy clinical study. Due to a delay in
obtaining U.S. Food and Drug Administration (“FDA”) clearance for the INVOcell,
venture capital investments ceased and, by the end of 2006, Medelle ceased
operations. Medelle assigned all of its assets to a trustee who
liquidated those assets and distributed the proceeds to creditors. In
that process, Dr. Ranoux purchased all of the assets of Medelle for $20,000 and
contributed those assets to Bio X Cell, Inc. upon its formation in January 2007,
including four patents related to the INVOcell technology.
On
December 5, 2008, Bio X Cell, Inc., doing business as INVO Bioscience, and each
of the shareholders of INVO Bioscience (the “INVO Bioscience
Shareholders”) entered into a share exchange agreement (the “Share Exchange
Agreement”) and consummated a share exchange (the “Share Exchange”) with our
predecessor Emy’s Salsa Aji Distribution Company, Inc. (“Emy’s”). Upon the
closing of the Share Exchange on December 5, 2008 (the “Closing”), the INVO
Bioscience Shareholders transferred all of their shares of common stock in INVO
Bioscience to Emy’s. In exchange, Emy’s issued to the INVO Bioscience
Shareholders an aggregate of 38,307,500 shares of Emy’s common stock,
representing 71.9% of the shares issued and outstanding immediately after the
Closing. As a result of the Share Exchange, INVO Bioscience became a
wholly-owned subsidiary of Emy’s.
After
the Closing, the Company had 53, 245,000 shares of common stock
outstanding.
At
Closing, Emy’s officers and directors resigned from their
positions. Kathleen Karloff was appointed as Chief Executive Officer,
Secretary and Director and Dr. Claude Ranoux was appointed as President,
Treasurer and Director.
Immediately
following the Closing, the Company entered into a securities purchase agreement
(the “Securities Purchase Agreement”) with GRQ Consulting, LLC and Whalehaven
Capital Fund Limited. Pursuant to the Securities Purchase Agreement,
the investors invested $375,000 in exchange for 375,000 shares of our common
stock at a price of $1.00 per share, subject to anti-dilution
protection.
After the
Closing, the Company had 53, 245,000 shares of common stock
outstanding.
COMPANY OVERVIEW
We are a
development stage company that has recently begun to commercialize our proven
and patented technology that we believe will revolutionize the treatment of
infertility. Our device, the INVOcell, and the INVO procedure are
designed to provide an alternative infertility treatment for the patient and the
clinician; it is less expensive and simpler to perform than current infertility
treatments. The simplicity of the INVO procedure relates to the
ability to potentially perform the infertility procedure in a physician’s
practice rather than in a specialized facility at a much lower cost overall than
current infertility treatments, including in vitro fertilization (“
IVF
”). Therefore,
we believe that the INVO procedure will be available in many more locations than
conventional IVF especially outside the United States. INVO also
allows conception and embryo development to take place inside the woman's body;
an attractive feature for most couples.
In May
2008, we received notice that the INVOcell product meets all the essential
requirements of the relevant European Directive(s), and received CE
Marking. The CE marking (also known as CE mark) is a mandatory
conformity mark on many products placed on the single market in the European
Economic Area (EEA). The CE marking (an acronym for the French
“Conformité Européenne”) certifies that a product has met EU health, safety and
environmental requirements, which ensure consumer safety. With CE
marking, we possess the regulatory authority to distribute its product in the
European Economic Area, provided we comply with local registration requirements
as discussed herein (
i.e.,
the European Union, Canada, Australia, New Zealand and most parts of the
Middle East). We have sold approximately 900 INVOcell units through
September 30, 2009.
THE
INVOCELL TECHNOLOGY
Our
product, the INVOcell medical device, is designed to treat infertility at a far
lower cost than other treatments available in today’s marketplace, including
IVF. The INVOcell technology is a fertility treatment where either
mild ovarian stimulation or no ovarian stimulation is used. Using a
mild stimulation protocol, 1-10 follicles are retrieved in a physician’s office
with the patient under light sedation with or without local
anesthesia. The follicle retrieval is performed using a vaginal probe
under ultrasound guidance. Eggs are identified immediately after
retrieval in the follicular fluid. During the INVO procedure,
fertilization and embryo development occurs inside the woman’s vaginal cavity in
a disposable single use device -- the INVOcell -- that holds the eggs, sperm and
culture medium.
Sperm
collection and preparation generally occur before egg
retrieval. Nutrient medium (~1ml) is placed in the inner vessel of
the INVOcell. Eggs and a fraction of motile sperm are placed into the
medium and the inner vessel is closed and secured in the protective outer
vessel. The INVOcell is placed in the patient’s vaginal cavity for an
incubation period of 2-3 days. A retention system can be used to
maintain the INVOcell system in the vagina during the incubation
period. The retention system consists of a diaphragm with holes in
the membrane to allow natural elimination of vaginal secretions. The
INVOcell is designed so that no vaginal fluids penetrate the outer vessel thus
ensuring that the inner vessel is not contaminated. Obtaining eggs,
sperm and media then inserting them into the INVOcell and then placing it in the
vagina takes approximately 90 minutes.
After 2-3
days, the patient returns to the physician’s office where the retention system
and the INVOcell are removed. The protective outer vessel is
discarded and the inner vessel is placed in INVO Bioscience’s patented holding
block in a vertical position for 15 minutes. Embryos are collected in
the micro chamber located at the bottom of the inner vessel. The
embryos can be directly viewed in the micro chamber in the holding block by
using a microscope. Embryos can be loaded directly from the device in
a transfer catheter from the INVOcell device. A trained clinician can
readily identify the best embryos for transfer. The embryos to be
transferred are aspirated into a standard catheter for transfer into the
patient’s uterus. This second visit should take approximately 45
minutes. All INVO related medical procedures can be performed in a
physician’s office thereby avoiding the requirement of an IVF facility and the
associated costs to build and maintain such a facility.
SUMMARY
OF OPERATIONS
INVO
Bioscience operates by outsourcing many key operational functions in the
development and manufacturing of the INVOcell device to keep fixed costs to a
minimum. Our most critical management and leadership functions are
carried out by our core team. We have contracted out the following
functions: manufacturing, packaging/labeling and sterilization of the device to
a certified manufacturer to mold the parts; to a medical manufacturing company
to assemble packages and label the product and to a sterilization specialist to
perform the gamma sterilization process. This expedites production
and eliminates the need for in-house capital equipment
expenditures.
To date,
we have completed a series of important steps in the development and
manufacturing of the INVOcell:
·
|
Manufacturing
: All
parts and processes have been validated. Manufacturing of
inventory is ongoing. To date, we have 400 INVOcell devices
ready for sale. We have an additional 9,000 devices molded and
ready for sterilization and
packaging.
|
·
|
CE
Mark
: INVO Bioscience has obtained a CE Mark that will
allow sales of INVO in Europe, Canada and many other countries, subject to
local registration requirements.
|
·
|
Clinical
Trials
: Safety and efficacy of the INVOcell device has
been demonstrated and accepted by both the CE Mark governing body and the
FDA.
|
·
|
Support of
Practitioners
: Clinicians and laboratory directors
having used the INVO method are enthusiastic about the fact that it is a
patient-friendly procedure, easy to perform, simple and
efficacious.
|
·
|
Initiate FDA
Clearance
: In parallel to the sale of products outside of the
United States in Europe, Canada, Mid-East and South America,
INVO Bioscience intends to complete, subject to receipt of additional
funding, all clinical and non-clinical studies by 2010 and thereafter
intends to finalize its FDA 510 (k) filing and hopefully receive FDA
clearance in early 2011.
|
·
|
Marketing
Trials/Studies
: Currently clinical studies are underway in South
America, the Mid-East and soon to commence in India by doctors currently
using the INVOcell to have “local” data on patient efficacy and experience
for marketing collateral and
advertising.
|
CURRENT
MARKET OPPORTUNITY
According
to the
European Society for
Human Reproduction
(“ESHRE”) in 2007, there are more than 100 million
infertile couples in the world. While there have been large increases
in the use of IVF, only about one million IVF cycles were performed in 2006,
which amounts to a treatment of less than 1% of the infertile couples
worldwide. Knowing that an average of 2-3 cycles of IVF is performed
per infertile couple, there are only 300,000-500,000 couples treated by
IVF. A survey by “
Resolve: The National Infertility
Association
,” the number one reason couples do not use IVF is cost and
geographical availability. We can provide a locally available
treatment option at less than half the cost of IVF that will help millions of
infertile couples throughout the world where IVF is not currently
available.
IVF is an
effective treatment option for many infertile couples. Our patented
and proven INVO technology is a low cost, unique fertility treatment option that
is much simpler to perform than IVF. The procedure can be provided
without an IVF center and therefore can be available in many more locations than
IVF. We believe we are well positioned to capture a significant share
of the unmet market needs. With the INVOcell device and technique,
fertilization and early embryo development is done within the vaginal cavity
rather than an incubator. Oocytes and sperm are fertilized and
developed into embryos within the INVO device while contained by the woman’s
vaginal cavity.
Currently,
according to
European
Society for Human Reproduction (ESHRE, 2007)
the 1% of infertile couples
who receive infertility treatment, including IVF, intra uterine insemination
(“IUI”) and other fertility treatment, represents a $6 billion worldwide
market. This leaves 99% of the infertile couples untreated with an
estimated unmet market opportunity of $594 billion, a portion of which, we
believe will be met by the INVO device. Much of the unmet market is
located in developing countries where many patients cannot afford, and have
limited access to, IVF. We believe that developing countries offer a
large and ready market for the INVOcell.
In May
2008, we received notice that the INVOcell device meets all of the essential
requirements of the relevant European Directive, and received CE
marking. The CE marking (also known as a CE mark) is a mandatory
conformity mark on many products placed on the single medical device market in
the European Economic Area (
i.e.,
Europe, Canada,
Australia, New Zealand and most parts of the Middle East)
(“EEA”). The CE marking (an acronym for the French "Conformité
Européenne") certifies that a product has met European health, safety and
environmental requirements, which ensure consumer safety.
Manufacturers in Europe and abroad must meet CE marking requirements where
applicable in order to market their products in Europe. With CE
marking, we now have the necessary regulatory authority to distribute our
INVOcell device in the EEA, subject to local registration
regulations.
Currently,
we are continuing to establish agreements with distributors and train physicians
in the areas outside of the US they include Canada, South America, Latin
America, Europe, the Middle East and Africa. While we penetrate the
infertility markets in Europe and Canada along with the certain developing
countries, we anticipate also pursuing the completion of the FDA ’ s “510(k)”
process. We have completed the first step for medical device
companies who manufacture Class 2 devices (and a small number of Class 1 and 3
devices), the filing of a Premarket Notification with the FDA (
i.e.,
an FDA 510(k)
submission). Technically, the FDA does not "approve" Class 1 and 2 medical
devices for sale in the U.S. they give "clearance" for them to be
sold. We believe we are presently halfway completed with our clinical
trial and anticipate its completion by the end of 2010, subject to funding
through the AGS REF or other sources. However, there can be no
assurance that our trial will be successful and that we will receive FDA
clearance thereafter.
COMPETITION
The
infertility industry is highly competitive and characterized by technological
improvements. New artificial reproductive technology (“ART”)
services, devices and techniques may be developed that may render the INVOcell
obsolete. Competition in the areas of infertility and ART services is
largely based on pregnancy rates and other patient
outcomes. Accordingly, the ability of our business to compete is
largely dependent on our ability to achieve adequate pregnancy rates and patient
satisfaction levels. The INVO procedure will offer an alternative
treatment to couples who currently do not have access to treatments because of
cost or location. Infertility clinics can expand their businesses by
offering INVO in satellite centers that can be opened at a substantially lower
cost than an IVF center. We are not aware of any direct competitors
to INVO Bioscience or the INVO process using the INVOcell
device. However, there are existing infertility treatment regimes
that the INVOcell will compete with when the infertile couple, in conjunction
with their physician, is choosing the treatment method for their
infertility. We believe that the menu of currently available clinical
infertility treatment methods generally is limited to IUI and
IVF.
Competing
Treatments
Intra Uterine Insemination
(IUI)
:
In
IUI treatments, ovarian stimulation protocols with induction of ovulation are
frequently used to recruit several follicles and improve clinical pregnancy
rates. When monitoring ovulation indicates that the female patient is
ready to ovulate, the male patient will produce a sperm sample in the fertility
doctor’s office. The sperm is then prepared and delivered to the
uterus through a catheter. IUI can only treat approximately 40% of
the causes of infertility. For example, IUI does not address
infertility causes such as tubal disease and other conditions that are treatable
by IVF and the INVOcell device and process. In addition, IUI does not
produce the diagnostic information such as fertilization that an IVF or INVO
cycle produces. Approximately 600,000 IUI cycles are performed
annually by a subset of 5,000 of the 40,000 fertility doctors in the U.S. as
well as by IVF providers. In Europe, at least 550,000 IUI cycles are
performed annually. The cost of a single IUI treatment can range from
$500 to $4,000 per cycle in the U.S. and $500 to $2,000 in
Europe. The intra-country differences in cost depend on the
stimulation protocol and the accuracy of the ovulation monitoring used by
physician.
In Vitro Fertilization
(IVF)
:
IVF
addresses tubal factor, ovulatory dysfunction, diminished ovarian reserve,
endometriosis, uterine factor, male factor, unexplained infertility and other
causes. IVF bypasses the function of the fallopian tube by achieving
fertilization within a laboratory environment. Ovarian
hyper-stimulation is common with IVF treatments to recruit numerous follicles
and increase the chances for success. Follicles are retrieved
trans-vaginally using a vaginal probe and ultrasound
guidance. General anesthesia is frequently used due to the number of
follicles retrieved and the resulting discomfort experienced by the
patient. The eggs are identified in the follicular fluid and combined
with sperm and culture medium in culture dishes, which are placed in an
incubator with a temperature and gas environment designed to mimic the condition
of the fallopian tubes. Once the embryos develop, they are
transferred to the uterine cavity. The transfer of several embryos
allows an average success rate for IVF of 27%, but it is also responsible for a
high multiple birth rate of approximately 40% of IVF
pregnancies. Multiple births bring risks to mother and babies and
significant expenses for third party payers. In addition, due to the
high number of embryos produced in IVF, cryo-preservation of excess embryos
occurs in more than 30% of the cycles. In the U.S., there are
approximately 1,000 reproductive endocrinologists who collectively perform more
than 125,000 IVF cycles per year at 430 specialized facilities. In
Europe, nearly 300,000 IVF cycles are reportedly performed at more than 1,000
facilities.
The cost
to the patient for a single IVF cycle (including drugs) averages $12,400 in the
U.S. and can go as high as $20,000 depending on the IVF center. The
cost of drugs for an IVF cycle ranges from $2,500 to $3,500. The
average cost per live birth using IVF can exceed $50,000 since the successful
patient generally requires more than one cycle. Many patients who
would be good candidates for IVF are unable to access it because of the high
cost and lack of insurance reimbursement. Additional obstacles to IVF
often include significant distances to IVF clinics; travel costs; and time off
from work. In addition, some couples experience concerns regarding
IVF such as the possibility of laboratory errors resulting in receiving another
person’s embryo.
Competitors
We
operate in a highly competitive industry, which is subject to competitive
pricing and rapid technological change. The market for fertility treatment
and devices are highly competitive in terms of pricing, functionality and
service quality, the timing of development and introduction of new products and
services and terms of financing. We face competition from all ART
practitioners and device manufacturers. Our competitors may implement
new technologies before we do, allowing them to offer more attractively priced
or enhanced products, services or solutions than we provide. Most of our
competitors may have greater resources in certain business segments or
geographic markets than we do. We may also encounter increased
competition from new market entrants or alternative ART
technologies. Our operating results significantly depend on our
ability to compete in this market environment, in particular on our ability to
adapt to economic or regulatory changes, to introduce new products to the market
and to enhance the functionality while reducing the cost of new and existing
products.
Our
principal ART medical-device competitor is Anecova, a Swiss start-up life
sciences company with an intrauterine device under development for infertility
treatment. This device is a very small silicone tube with 360 micro
perforations. Oocytes are fertilized outside the device and then
placed in the tube, which is placed inside the woman’s uterus for early embryo
development. After 1-5 days, the device is removed and the best
embryo(s) are transferred back into the woman’s uterus. We believe
that the device is much more difficult to use than the INVOcell due to its size
and the requirement to place the device in the uterus, a sterile
environment. The precision manufacturing of the Anecova device will
drive its cost close to $1,500, which is higher than our price. If
the Anecova device is shown to be effective, it is likely that the device would
only be available in hospitals and IVF Centers at a significantly higher cost
than the INVOcell. This procedure still needs the complex equipment
of an IVF center.
Competitive
Advantages
We
believe that the INVOcell has the following competitive advantages:
Lower cost than IVF with
similar efficacy
: The INVOcell is substantially less expensive
than IVF due to the shorter time to execute the procedure, lower costs of
supplies, labor, capital equipment and overhead. An IVF center
requires at least $500,000 of laboratory capital equipment and highly trained
personnel. In contrast, the cost of laboratory capital equipment to
set-up an INVOcell procedure is approximately $30,000 and does not require
highly trained specialists beyond the traditional obstetrician and gynecological
practice. The global success rate for IVF varies dramatically from
13.6% to 40.5% with an average of 27% per cycle (ESHRE, ICMART Committee, June
21, 2006). We foresee INVO will be offered at approximately $5,000
per cycle with a pregnancy rate comparable to traditional IVF (20% versus 27%,
INVO to IVF, respectively). In Europe, IUI currently averages $1,000
per cycle and IVF averages $5,000. INVO in Europe will be offered at
approximately $2,500 per cycle. In Europe, the average cost per
pregnancy for IVF is $21,354.
Similar cost than IUI with
greater efficacy
: In the U.S. currently, IUI averages $1,500 per cycle
with <10% pregnancy rate while IVF averages $12,400 per cycle with an average
of 27% pregnancy rate. With INVO, we believe that the Ob/Gyn or
reproductive endocrinologist practitioners will benefit by providing a superior
product than IUI with good financial margins, efficacy rates more than double
IUI while treating the full range of infertility indications. In
Europe, the average cost per pregnancy using IUI is $12,000. The
average cost per pregnancy for IVF is $21,354 while for INVO it is only $13,888:
a savings of more than $7,000 per pregnancy. Using INVO could reduce
annual infertility costs in Europe by more than $650 million.
Greater geographic
availability
: In Europe, there are more than 1,000 IVF
centers, and there are approximately 430 IVF centers in the U.S. In
addition, by having INVO geographically available in Ob/Gyn offices, couples
will not have the travel costs and absence from work associated with IVF
treatments. The medical staff at these centers could easily learn
INVO and offer it as a lower cost treatment option for their patients through
satellite centers. There are also 5,000 Ob/Gyn physicians in the U.S.
who offer infertility services (IUI). Since INVO does not require a
specialized lab facility, large costly equipment or highly specialized staff, it
may possible be offered in a doctors’ office setting. Therefore, in
the U.S. alone, INVO could be 10 times more available than conventional
IVF. This also allows Ob/Gyn offices worldwide to offer INVO as an
alternative or follow up treatment to IUI and generate a significant new revenue
stream.
Greater patient
involvement
: With INVO, the patient uses her own body as the incubation
environment. This creates a greater sense of involvement, comfort and
participation for patients who know that the fertilization is happening within
their own bodies. In some cases, this frees the couples from ethical
or religious concerns, or fears of laboratory mix-ups that could result in a
patient receiving another couple’s embryo(s).
SALES
AND MARKETING
Product
Pricing
We
anticipate employing the following pricing system for the INVOcell
technology. These prices were determined through discussions with our
advisory board of physicians and potential strategic partners and reflect the
innovative features of the device, the savings in physician’s laboratory fixed
costs and the amount that a physician will receive from patients to perform
INVO. Our goal is to have the INVO procedure be a lower cost alternative, with
comparable success rates.
INVOcell device
:
We
expect to sell the INVOcell device and its retention system for between $75 and
$400 per unit. IVF centers or Ob/Gyn groups purchasing a large number
of devices and promoting the INVO process will receive discounted prices and a
limited amount of free advertising of their facility on our
website. It is expected that the INVOcell will sell for $400 in the
U.S., which grants a single-use license under our patents. In Central and
South America and Europe, the price of the device will be reduced to between
$100-$300 to reflect a generally lower cost of infertility procedures in most of
these countries and to make INVOcell available to populations with lower
incomes.
Holding/Warming
Blocks
:
The
holding blocks will be sold as a tool for viewing and retrieving the embryos
from the inner chamber. Each physician will need a minimum of two
blocks depending on the number of cycles he/she performs. The blocks
cost $100 per block and will sell for $200 and will constitute an additional
revenue stream.
Fixed Laboratory
Equipment
: The equipment used in the INVO procedure (microscope with
video system, bench centrifuge, incubator without CO
2
, bench
warmer and laminar flow hood) is readily available in the market. We
have had initial discussions with an equipment supplier that has a mobile bench
and hood with all the required equipment. We intend to establish an
agreement with this company to provide our customers with a discount and
financing to facilitate new customer entry into the INVO market in the future,
however, there can be no assurance that we will be successful in this
effort. The complete set up for the INVO procedure is approximately
$33,000 in Europe and $50,000 in the U.S.
Our
Sales Team
As of the
date of this prospectus, we employ two sales and marketing individuals who are
charged with all of our sales efforts. We anticipate growing our
sales team to eight in 2010, subject to raising additional
capital. Our sales efforts follow two approaches:
Direct Physician Sales
through Distributors
-- In many countries, we intend to establish local
distributors to access the countries’ markets. With the
distributor-to-physician model, the distributors will be selling to IVF centers,
medical practices and physicians directly. We will support the
distributor’s efforts with training, both to the distributor’s trainers as well
as to the physicians directly. We current maintain distribution
agreements in the following countries: Canada, Colombia, Venezuela, Ecuador,
Panama, Argentina, Peru, Pakistan, Turkey and Taiwan. Additionally we are in
discussions with potential distributors for Spain, Greece, Cyprus, Bulgaria,
Poland, Russia, Egypt, India, and South Africa
Direct Sales to
Physicians
-- We are also following a parallel path directly to leading
infertility doctors in regions where there is demand but either distributors do
not exist such as in Western Africa or we have not yet signed distribution
agreements.
Target
Markets
Currently
and through 2010, we anticipate that we will launch the sale of the INVOcell
device in Europe, Canada, South America and the Middle East. During
2011, or at such time that we receive FDA approval, we anticipate launching the
INVOcell in the U.S. In 2010, we also anticipate the launch of the
INVOcell device in India and Russia. In 2011, we anticipate the
launch of the INVOcell device in China and other countries where an alternative
treatment is needed. With the cost of the INVO procedure being less
than half the cost of IVF, we expect to penetrate 5% of the currently untreated
infertility market, although no assurances can be made in this
regard.
Worldwide
--
According to the
European
Society for Human Reproduction
(ESHRE, 2007) there are more than 100
million infertile couples in the world. About one million IVF cycles
were performed in 2006, which is less than 1% of the infertile couples
worldwide. More than 99 million infertile couples remain untreated
due to cost, availability, awareness and other factors.
U.S.
-- According to
the Centers for Disease Control, 7.3 million people in the U.S. have difficulty
conceiving. With only 350,000 couples receiving fertility treatment,
more than six million couples receive no treatment. According to
Integramed, Inc., a U.S. based network of fertility centers, 97% of the
untreated infertile couples do not receive treatment due to
cost. Working with our advisory board, we estimate that an INVO
procedure in the U.S. will cost approximately $5,000
dollars.
Europe
-- Europe has
approximately 10 million infertile couples, of which 137,000 are estimated to
have received IVF treatment and 183,000 received IUI (ESHRE) leaving 9.5 million
infertile couples untreated.
Preliminary
Sales Strategy
We have
received the CE Mark that allows us to sell product in Europe, Canada and other
countries in South America, the Middle East, and Africa along with Russia, and
India subject to local registration requirements. Our strategy is to
launch the product in the developing world first because of the high demand and
relatively low availability of IVF procedures.
Launching
INVO in the U.S. market requires 510(k) clearance, which we anticipate receiving
in early 2011 upon completion of our clinical trials estimated for 2010 based on
adequate funding from the REF.
We have completed the
required human confirmatory study. The births of normal babies have
been confirmed in this study using the INVOcell. It will take nine
months and approximately $1,000,000 of funding to complete the data collection
on all required subjects, analyze the data, have an independent audit and submit
the full 510(k) to the FDA. The FDA has 90 days to review the
submission from INVO Bioscience. All preclinical data and testing has
been completed and reviewed by FDA. We expect to receive approval to
sell the INVOcell without further studies at that time. However,
there is no assurance that will be the case. We intend to launch
INVOcell through key IVF centers in the U.S. once FDA clearance is
achieved. Our U.S. based board of advisors and participants in our
clinical trials have indicated a desire to be among the first to offer the
INVOcell to their patients. The success of these IVF centers with the
INVOcell will assist in expanding our share of the market in the
U.S. We will also target the 5,000 Ob/Gyn doctors with experience in
infertility treatment.
Insurance
Reimbursement for Infertility Treatment
Most
European countries have some level of coverage for infertility treatment, but
the level of coverage varies from country to country and even within
countries. For example, the National Health Service in the UK covers
20% of most costs for infertility treatment. However, that standard
is not applied universally throughout the country and some counties provide
almost none. In the U.S., fifteen states mandate some form of
insurance reimbursement for infertility treatment. Three states
mandate reimbursement for IVF, while other states cover some form of infertility
treatment, but they may also specifically exclude IVF due to cost. In
addition, fifteen other states are considering mandating some form of coverage
for infertility treatment. Finally, there are bills under
consideration in the U.S. Congress for a federal mandate to provide insurance
coverage for infertility treatments universally across the nation.
We
believe that the INVOcell process will be treated favorably by insurance
companies because it lowers cost and has a high efficacy rate. In
Europe, the average cost per pregnancy using IUI is $12,000 and IUI is
appropriate for only 40% of the infertile population. However, for
INVO, which is marginally more expensive at $13,888 per pregnancy, is a more
effective treatment for a majority of infertile couples. The average
cost per pregnancy for IVF is $21,354. Therefore, there is a savings
of more than $7,000 (over 33%) per pregnancy by using INVO versus
IVF. Using INVO could reduce infertility costs in Europe by more than
$650 million.
Currently,
many third-party payers require that an infertile patient have at least three
cycles of IUI before going on to IVF. The aggregate success rate of
three IUI’s is 25%. Therefore, up to 75% of those patients are often
referred to IVF. In the future, third-party insurance payers could
save more than $7,000 per pregnancy by requiring the patient to try INVOcell
first.
Branding
and Promotion
We have a
new logo refined for the infertility market. We have trademarked the
logo, device and technology. At the same time, we are developing a
website that includes special pages for clinicians and
patients. Subject to available capital, the next generation website
will include materials that medical professionals and patients can print,
including status reports and news items. It will include a training
videos for potential customers both physician and patients who want to learn
exactly how the INVOcell works.
REGULATION
Domestic
Regulations
The
manufacture and sale of our products are subject to extensive regulation by
numerous governmental authorities, principally by the FDA in the U.S. and
corresponding foreign agencies. The FDA administers the Federal Food,
Drug and Cosmetic Act and the regulations promulgated there under. We
are subject to the standards and procedures with respect to the manufacture of
medical devices and are subject to inspection by the FDA for compliance with
such standards and procedures. The FDA classifies medical devices
into one of three classes depending on the degree of risk associated with each
medical device and the extent of control needed to ensure safety and
effectiveness. The INVOcell device and process must secure a 510(k)
pre-market notification clearance before it can be introduced into the
United States market. The process of obtaining 510(k) clearance
typically takes several months and may involve the submission of limited
clinical data supporting assertions that the product is substantially equivalent
to an already approved device or to a device that was on the market before the
enactment of the Medical Device Amendments of 1976.
Every
company that manufactures or assembles medical devices is required to register
with the FDA and adhere to certain “good manufacturing practices” in accordance
with the FDA’s Quality System Regulation, which regulates the manufacture of
medical devices, prescribes record-keeping procedures and provides for the
routine inspection of facilities for compliance with such
regulations. The FDA also has broad regulatory powers in the areas of
clinical testing, marketing and advertising of medical devices.
Medical
device manufacturers are routinely subject to periodic inspections by the
FDA. If the FDA believes that a company may not be operating in
compliance with applicable laws and regulations, it can:
·
|
place
the company under observation and re-inspect the
facilities;
|
·
|
issue
a warning letter apprising of violating
conduct;
|
·
|
detain
or seize products;
|
·
|
enjoin
future violations; and
|
·
|
assess
civil and criminal penalties against the company, its officers or its
employees.
|
At
present, we believe are more than halfway completed with the clinical trials
requested by the FDA through our predecessor company. Subject to
available capital, we anticipate completing those clinical trials by the end of
2010. Thus, we believe that we will receive FDA clearance by 2011,
though there can be no assurance that we will be successful in doing so on a
timely basis, if at all.
International
Regulations
We are
also subject to regulation in each of the foreign countries where our products
are sold. Many of the regulations applicable to our products in such
countries are similar to those of the FDA. The national health or
social security organizations of certain countries require that our products be
qualified before they can be marketed in those countries. Many of the
countries we are targeting do not have a formal approval process of their own
but rely on either FDA clearance or the European approval, CE Mark, they follow
that up with a registration process of listing the INVOcell with the governing
body.
Our
activities during our development stage have included developing the business
plan, seeking regulatory clearance in Europe and the United States and raising
capital. In May 2008, we received notice that the INVOcell product
met all the essential requirements of the relevant European Directive(s), and
received CE marking. The CE mark is a mandatory conformity mark on
many products placed on the single market in the European Economic Area
(EEA). The CE mark (an acronym for the French "Conformité
Européenne") certifies that a product has met EU health, safety and
environmental requirements, which ensure consumer safety.
With CE
marking, we now have the ability and necessary regulatory authority to
distribute our product after registration in the European Economic Area (
i.e.,
Europe, Canada,
Australia, New Zealand, along with most parts of the Middle East and
South America). Every country is different we have completed registrations in
some, are in process with others, upon funding from the REF we will be
submitting additional registrations and for a few others we have to wait until
we have FDA clearance. We are registering the product based on the size of the
market and our ability to service it given our resources.
INTELLECTUAL
PROPERTY
More than
800 cases of an INVO procedure have been documented in peer-reviewed journals
since the 1980s, using an incubation device not specifically designed for the
process but functionally capable of demonstrating success rates equivalent to
IVF at that time. The INVOcell device was specially developed and
manufactured to optimize the ease of use and effectiveness of the procedure at
an affordable price. This product development process has resulted in
five active patents worldwide covering both the INVOcell device and the INVO
process.
LEGAL
PROCEEDINGS
We are
not involved in any lawsuit outside the ordinary course of business, the
disposition of which would have a material effect upon either our results of
operations, financial position or cash flows.
PROPERTY
We
currently do not own any property. Our principal executive office is
located at 100 Cummings Center, Suite 421E, Beverly, Massachusetts 01915,
pursuant to a lease entered into by INVO Bioscience in January 2007 for 3,294
square feet of general office space. The lessor is Cummings
Properties, LLC and the lease commenced in January 2007 and concludes on
December 31, 2010. The lease is subject to a cost of living increase
equal to the Boston, Massachusetts Consumer Price Index at the beginning of each
calendar year.
EMPLOYEES
As of
September 30, 2009, we have 5 full-time employees. We consider our
relationship with our employees to be good.
The
following table sets forth the names and positions of our directors and
executive officers and other key personnel as of September 30,
2009:
|
|
|
|
|
|
|
|
|
|
Name
|
|
Age
|
|
Position
|
Kathleen
T. Karloff
|
|
54
|
|
Chief
Executive Officer, Secretary and Director
|
Dr.
Claude Ranoux
|
|
58
|
|
President,
Treasurer, Chief Scientific Officer and Director
|
Robert
J. Bowdring
|
|
52
|
|
Chief
Financial Officer
|
Each
Director holds office until the next annual meeting of the shareholders or until
his successor is elected and duly qualified. Executive officers are appointed by
and serve at the pleasure of the Board of Directors. The following sets forth
biographical information concerning our directors, and executive officers for
the past three years:
Kathleen T. Karloff
, Chief
Executive Officer, secretary and member of the Board of Directors, co-founded
INVO Bioscience in January 2007. Since that time, Ms. Karloff has
obtained ISO certification and the CE mark for the INVOcell device and has
implemented manufacturing and distribution systems. From 2000 through
2003, Ms. Karloff was the Vice President of Operations for a start-up company
called Control Delivery Systems, which was developing an intra-ocular drug
therapy for Uveitus and Diabetic Macular Edema. That company was
acquired by Psivida LTD in December 2005. From 2004 until September
2006, Ms. Karloff was the Vice President of Operations for Medelle
Corporation. Prior to that, she has held various positions at Boston
Scientific during 13 years of dynamic growth from 1983 to 1997 her last position
being the Director of Manufacturing. Since leaving Boston Scientific,
she has been Vice President of Operations on start-up teams of three
device/pharmaceutical companies. Ms. Karloff earned her B.S. in
microbiology from Montana State University and attended Northeastern University
for MBA coursework.
Dr. Claude Ranoux,
President,
Treasurer and member of the Board of Directors, co-founded INVO Bioscience in
January 2007. He has more than 30 years of experience in the research
and treatment of infertility; he is the inventor and developer of the INVO™
procedure and INVOcell device. From 2000 through 2005, Dr. Ranoux was
president of Medelle Corporation and worked on development of the
INVOcell. Dr. Ranoux has built and run 12 IVF centers worldwide and
has established 12 reproductive centers worldwide. Before founding
INVO Bioscience and recruiting the highly experience management team, Dr. Ranoux
had 6 years of experience in creating and finding financing for a
start-up company. He has been scientific consultant for a new
instrument (Immuno1) from Bayer Corporation. During this
collaboration, the North West area became the first area for the sales of the
instrument 2 years in a row.
Dr. Ranoux was the
founder of several non-profit organizations and foreign trade advisor in the New
England area. Dr. Ranoux earned his M.D. and his M.S. in Reproductive
Biology from the Medical University of Paris (V & XI) where he was an
Associate Professor. Dr. Ranoux has served as a scientific consultant
for eight other centers and is
the author of numerous
scientific publications as first author. He has given numerous
invited lectures, conferences and workshops and is the author of five medical
and scientific theses and mentor for several others. He is co-author
of six scientific and medical films. He received a prize for the one
of the best scientific presentation at the
Fifth World Congress in IVF, in
Norfolk, VA,
and is the recipient of several other awards. Dr.
Ranoux is the main inventor in six international patents.
Robert J. Bowdring,
Chief
Financial Officer, Mr. Bowdring joined the Company as its Corporate Controller
in October 2008. In January 2009, the Company appointed Mr. Bowdring
as its Chief Financial Officer. From April 2003 to August 2008, Mr.
Bowdring served as Vice President of Finance and Administration for Cyphermint,
Inc., a software development firm. For the fourteen prior years, he
was the Controller and Vice President of Lifeline Systems Inc., a public
manufacturing and service company (NASDAQ: LIFE) in the personal emergency
response market. Mr. Bowdring has a strong history in senior
financial management with more than 25 years experience serving in capacities
such as chief financial officer, vice president of finance and controller.
Rob has been in both public and private manufacturing and service companies
throughout his career. Mr. Bowdring has a Bachelors degree in
Accounting from the University of Massachusetts in Amherst.
Board
of Directors
Currently,
we only have two board members, Claude Ranoux and Kathleen Karloff, who are also
our CEO and President. We expect to add three independent members to
expand our Board of Directors to five in 2010, depending upon our ability to
reach and maintain financial stability.
Committees
of the Board of Directors
We do not
currently have an Audit Committee, Compensation Committee, Nominating Committee,
or any other committee of the Board of Directors. The responsibilities of these
committees are fulfilled by our Board of Directors and all of our directors
participate in such responsibilities. In addition, we do not currently have an
"audit committee financial expert" as such term is defined in the Securities
Act, as our financial constraints have made it extremely difficult to attract
and retain qualified outside Board members. We hope to add qualified independent
members of our Board of Directors in 2010, depending upon our ability to reach
and maintain financial stability.
Compensation
Committee Interlocks and Insider Participation
We do not
have a Compensation Committee or any other committee of the Board of Directors
performing similar functions during the years ended September 30, 2009. Kathleen
Karloff, our Chief Executive Officer, Claude Ranoux, President and Robert
Bowdring CFO make decisions relating to compensation.
Code
of Ethics
We have
adopted a Code of Ethics that applies to all employees including our officers,
our principal executive officer, our president and principal financial &
accounting officer.
Compensation
Discussion and Analysis
Compensation
before the Share Exchange
Prior to
the closing of the Share Exchange, the named executive officers received stock
awards as their compensation from February 2007 until June 2008. In
July 2008 through the year end of December 31, 2008, which included the closing
of the Share Exchange, our officers drew an annualized salary of $175,000
each. The named executive officers’ salaries did not change as a
result of the Share Exchange. The Board of Directors, who are also named
executive officers, determined the compensation for themselves and the other
executive officers and employees of INVO Bioscience. The members of the Board of
Directors do not receive separate compensation for serving as directors,
although it is anticipated that any non-employee directors who may be appointed
to the Board will be compensated in a manner to be determined by the Board at
such time as new directors are appointed.
Compensation
after the Share Exchange
From
January 1, 2009 to present the named executive officers compensation consisted
solely of each executive officer’s salary; no cash bonuses were paid or
accrued. On January 2, 2009, Mr. Robert J. Bowdring was promoted to the
position of Chief Financial Officer by the Board of Directors, thus making him a
named executive as of that date. From March 1, 2009 until present,
the named executive officers’ salaries have been accrued, but not paid, to
financially assist the Company during this period. The Board of Directors
of INVO Bioscience believes that the salaries paid and accrued to our executive
officers during 2008 and 2009 are indicative of the objectives of its
compensation program as this stage of our development.
Salary is
designed to attract, as needed, individuals with the skills necessary for us to
achieve our business plan, to motivate those individuals, to reward those
individuals fairly over time, and to retain those individuals who continue to
perform at or above the levels that we expect. When setting and
adjusting individual executive salary levels, we consider the relevant
established salary range, the named executive officer’s responsibilities,
experience, potential, individual performance and contribution. We
also consider other factors such as our overall corporate budget for annual
merit increases, unique skills, demand in the labor market and succession
planning. We determine the levels of salary as measured primarily by
the local market in Boston/New England, which determinations are made based on
anecdotal evidence rather than compensation studies or
surveys.
Corporate
performance goals include sales, margin and net profit
targets. Additional key areas of corporate performance taken into
account in setting compensation policies and decisions are new business
development, cost control, and innovation. The key factors may vary
depending on which area of business a particular executive officer’s work is
focused. Individual performance goals include subjective evaluation,
based on an employee’s team-work, creativity and management capability, and
objective goals such as sales targets. We have not paid bonuses to
our executive officers in the past. If we are successful in raising
capital and building our business, we intend to establish a bonus program for
all of our employees including our named executive officers. Although
no such program has been designed, the program is expected to be based on both
corporate and individual performance goals.
Our
intention is to establish a compensation committee comprised of both
non-employee and employee directors, once we expand the Board. The
compensation committee will perform, at least annually, a strategic review of
the compensation program for our executive officers to determine whether it
provides adequate incentives and motivation to our executive officers and
whether it adequately compensates our executive officers relative to comparable
officers in other companies with which we compete for
executives. Those companies may or may not be public companies or
companies located in the Boston area or even, in all cases, companies in a
similar business. We would like to establish a compensation program
for executive officers that is designed to attract, as needed, individuals with
the skills necessary for us to achieve our business plan, to motivate those
individuals, to reward those individuals fairly over time, and to retain those
individuals who continue to perform at or above the levels that we
expect.
We also
intend to expand the scope of our compensation, such as the possibility of
granting options or other stock-based awards to executive officers and tying
compensation to predetermined performance goals. We intend to adopt
an equity incentive plan in the near future and issue stock-based awards under
the plan to aid our long-term performance, which we believe will create an
ownership culture among our named executive officers that fosters beneficial,
long-term performance by our company. We do not currently have a
general equity grant policy with respect to the size and terms of grants that we
intend to make in the future, but we will evaluate our achievements for each
fiscal year based on performance factors and results of operations such as
revenues generated, cost of revenues, and net income. No such goals have been
determined for this fiscal year.
The
following Summary Compensation Table sets forth, for the years indicated, all
cash compensation paid, distributed or accrued for services, including salary
and bonus amounts, rendered in all capacities by the Company’s chief executive
officer, president and chief financial officer who received or was
entitled to receive remuneration in excess of $100,000 during the stated
periods. As reflected below, none of our officers received cash
compensation during fiscal 2007.
SUMMARY
COMPENSATION TABLE
Name and Principal
Position
|
|
Year
|
|
Salary
|
|
|
Bonus
($)
|
|
|
Stock
Award
($)
|
|
|
Option
Award ($)
|
|
|
Non-Equity
Incentive Plan Compensation Earnings ($)
|
|
|
Non-Qualified
Deferred Compensation Earnings ($)
|
|
|
All
other Compensation ($)
|
|
|
Total ($
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kathleen
Karloff, CEO/Director(1) (2)
|
|
2009
|
|
$
|
131,252
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
131,252
|
|
|
|
2008
|
|
$
|
93,074
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
93,074
|
|
|
|
2007
|
|
$
|
-
|
|
|
|
-
|
|
|
$
|
4,498
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
4,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Claude
Ranoux, President/Director(2) (3)
|
|
2009
|
|
$
|
131,252
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
131,252
|
|
|
|
2008
|
|
$
|
91,974
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
91,974
|
|
|
|
2007
|
|
$
|
-
|
|
|
|
-
|
|
|
$
|
19,731
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
19,731
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert
Bowdring, CFO (2)
|
|
2009
|
|
$
|
108,750
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
108,750
|
|
|
|
2008
|
|
$
|
24,518
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
24,518
|
|
|
|
2007
|
|
$
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
-
|
|
(1)
|
Kathleen
Karloff was elected as the Chief Executive Officer, Secretary and member
of the Board of Directors of the Company effective upon the resignation of
Andrew Uribe in connection with the Share Exchange between INVO Bioscience
and Emys on December 5, 2008. During 2007, Ms. Karloff received
shares of common stock valued at $.2857/share.
|
(2)
|
2009
salary includes both paid and accrued salary for all
officers.
|
(3)
|
Claude
Ranoux was elected as the President, Treasurer and member of the Board of
Directors effective upon the resignation of Andrew Uribe, in connection
with the Share Exchange between INVO Bioscience and Emys on December 5,
2008. During 2007, Dr. Ranoux received shares of common stock
valued at $.2857/share.
|
Stock
Option Grants
Since
January 1, 2008, we have signed agreements to compensate certain officers,
employees and service providers with common stock or options to acquire common
stock. As of December 31, 2008, a total of 857,000 shares of common
stock and options to purchase an additional 440,000 shares of common stock were
agreed to be issued. As of September 30, 2009, we have issued the
857,000 shares of common stock against its previously recorded accrued
liability. However, as of September 30, 2009, we terminated 70,000 of
the options and agreed to issue an additional 300,000 to two employees
hired during 2009 bringing the total options to 670,000 as of this
date. We have not yet adopted a formal stock option plan and,
consequently, the options to purchase 670,000 shares of common stock are deemed
not yet issued.
Long-Term
Incentive Compensation: We are looking to establish a program that
will provide long-term incentive compensation through awards of stock options,
restricted stock, and/or stock awards. Our equity compensation
program is intended to align the interests of the officers with those of our
shareholders by creating an incentive for our officers to maximize shareholder
value. The equity compensation program will be designed to encourage
officers to remain employed with us despite a competitive labor market, and the
fact that we are a development stage company and have a limited operating
history and limited revenue to date, and may not necessarily be able to sustain
a market rate base salary. Stock options, stock grants, warrants and
other incentives are based on combination of factors including the need and
urgency for such an executive, the experience level of the executive and the
balance of such incentives with a lower than market base salary or fees that is
paid in cash. Employees and consultants are granted such incentives from time to
time to maintain their continuing services, sometimes without increases in
salaries or fees.
Deferred
Compensation Benefits: We do not have a deferred compensation program
at this time.
Retirement
Benefits: We do not have a 401(k) plan or other retirement program at
this time.
Executive
Perquisites and Generally Available Benefits: We have no executive
perquisite program at this time.
Employment
Agreements; Termination of Employment and Change of Control
Arrangements
Kathleen
T. Karloff, Chief Executive Officer, Secretary and member of the Board of
Directors, has executed an employment agreement with INVO Bioscience effective
as of February 1, 2008. The agreement provides for an annual salary
of $175,000 and health and life insurance and retirement plan along with the
reimbursement of expenses. In the event that Ms. Karloff’s employment
is terminated other than for good cause (as defined in the employment
agreement), she will receive her salary and full medical benefits for twelve
(12) months thereafter.
Dr.
Claude Ranoux, President, Treasurer and member of the Board of Directors, has
executed an employment agreement with INVO Bioscience effective as of February
1, 2008. The agreement provides for an annual salary of $175,000 and
health and life insurance and retirement plan along with the reimbursement of
expenses. In the event that Dr. Ranoux’s employment is terminated
other than for good cause (as defined in the employment agreement), he will
receive his salary and full medical benefits for twelve (12) months
thereafter.
Robert J.
Bowdring, Chief Financial Officer, has executed an employment agreement with
INVO Bioscience effective as of October 27, 2008. The agreement
provides for an annual salary of $150,000 and health and life insurance and
retirement plan along with the reimbursement of expenses. In the
event that Mr. Bowdring’s employment is terminated other than for cause (as
defined in the employment agreement), he will receive a severance package of two
months of salary and full medical benefits per service year
Outstanding
Equity Awards
The Company has not yet adopted a
formal stock option plan. Accordingly,
there are no outstanding
equity awards as of September 30, 2009.
On
September 18, 2008, we entered into a related party transaction with Dr. Claude
Ranoux, the President, Director and Chief Scientific Officer of the
Company. Dr. Ranoux had loaned funds to the Company to sustain its
operations since January 5, 2007 (inception). Dr. Ranoux’s total
cumulative loans at September 30, 2009 were $70,462. On March 26, 2009,
the Company and Dr. Ranoux agreed to amend the agreement to a non-convertible
note payable bearing interest at 5% per annum and extended the repayment date to
March 31, 2010. The Company and Dr. Ranoux can jointly decide to repay the
loan earlier without prepayment penalties. During the three months and
nine months ended September 30, 2009, $26,000 was repaid on the principal of the
loan.
On March
5, 2009, we entered into a related party transaction with Kathleen Karloff, the
Chief Executive Officer and a Director of the Company. Ms. Karloff
provided a short-term loan in the amount of $75,000 bearing interest at 5% per
annum to the Company to fund operations. In May 2009, Ms.
Karloff loaned to the Company an additional $13,000, making her total
cumulative loan $88,000 as of September 30, 2009. This note was due
on September 15, 2009, which has since been extended to March 4,
2010.
The
following table sets forth certain information regarding the beneficial
ownership of our common stock as of December 11, 2009, (i) by each of our
directors; (ii) by each person known by us to own beneficially more than five
percent of our common stock; (iii) by the executive officer named in the Summary
Compensation Table set forth in "Executive Compensation" and (iv) by all of our
directors and executive officers as a group. Beneficial ownership is determined
in accordance with Rule 13d-3(d) promulgated by the SEC under the Securities
Exchange Act of 1934, as amended. Unless otherwise noted, each person or group
identified possesses sole voting and investment power with respect to the
shares, subject to community property laws where applicable. The percentage of
shares beneficially owned prior to the offering is based on 58,002,763 shares of
our common stock actually outstanding as of December 11, 2009.
Name
of Principal Shareholder
|
|
Number
of Shares Owned
|
|
|
Percent
of Shares
Outstanding
|
|
Dr.
Claude Ranoux
|
|
|
25,501,473
|
|
|
|
44.0
|
%
|
Kathleen
Karloff
|
|
|
5,862,159
|
|
|
|
10.1
|
%
|
Christopher
Esposito
|
|
|
3,931,763
|
|
|
|
6.8
|
%
|
Phillip
Warren
|
|
|
3,457,778
|
|
|
|
6.0
|
%
|
|
|
|
|
|
|
|
|
|
All
Officers and Directors as a Group (two persons)
|
|
|
31,363,632
|
|
|
|
54.1
|
%
|
We have
58,002,763 shares issued and outstanding as of December 11, 2009.
This
prospectus relates to the possible resale by the selling stockholder, AGS
Capital, LLC, of shares of common stock that we may issue pursuant to the
Reserve Equity Financing Agreement, or REF, that we entered into with AGS on
October 28, 2009. We are filing the registration statement of which this
prospectus is a part pursuant to the provisions of the registration rights
agreement we entered into with AGS on October 28, 2009.
The
selling stockholder may from time to time offer and sell pursuant to this
prospectus any or all of the shares that it acquires under the REF.
The
following table presents information regarding AGS and the shares that it may
offer and sell from time to time under this prospectus. This table is prepared
based on information supplied to us by the selling stockholder. As used in this
prospectus, the term “selling stockholder” includes AGS and any donees,
pledgees, transferees or other successors in interest selling shares received
after the date of this prospectus from a selling stockholder as a gift, pledge
or other non-sale related transfer. The number of shares in the column “Number
of Shares Being Offered” represents all of the shares that the selling
stockholder may offer under this prospectus. The selling stockholder may sell
some, all or none of its shares. We do not know how long the selling stockholder
will hold the shares before selling them, and we currently have no agreements,
arrangements or understandings with the selling stockholder regarding the sale
of any of the shares.
Beneficial
ownership is determined in accordance with Rule 13d-3(d) promulgated by the SEC
under the Securities Exchange Act of 1934, as amended. Unless otherwise noted,
each person or group identified possesses sole voting and investment power with
respect to the shares, subject to community property laws where applicable. The
percentage of shares beneficially owned prior to the offering is based both on
58,002,763 shares of our common stock actually outstanding as of December 11,
2009 and on the assumption that all shares of common stock issuable under the
REF we entered into with AGS are outstanding as of that date.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Beneficially Owned
Prior
to the Offering
|
|
Number
of
Shares Offered
|
|
|
Shares Beneficially Owned
After the Offering
|
|
|
Number
|
|
Percent
|
|
Number
|
|
|
Percent
|
|
AGS
Capital Group, LLC(1)
|
|
|
8,790,000
|
(2)
|
|
%
|
|
8,790
,000
|
|
|
|
—
|
|
|
|
—
|
|
(1) The
address of AGS is: 2 Water Street, 17
th
Floor, New York, New York
(2)
Consists of 8,790,000 shares of common stock issuable under the REF we entered
into with AGS on October 28, 2009. For the purposes hereof, we assumed the
issuance of the 8,790,000 shares of common stock issuable pursuant to the
REF, but no additional shares of common stock potentially issuable pursuant to
the REF. We will file subsequent registration statements covering the resale of
any additional shares of common stock beginning approximately 60 days after we
have substantially completed the sale to AGS under the REF of the shares subject
to this registration statement. Allen Silberstein has voting and investment
control of the securities held by AGS.
DESCR
IPTION OF CAPITAL STOCK
Our
authorized capital stock consists of 200,000,000 shares of common stock, $0.0001
par value and 100,000,000 shares of preferred stock, $0.0001 par value. As of
December 11, 2009, there were 58,002,763 shares of our common stock outstanding
that were held of record by approximately 98 stockholders, and options and
warrants to purchase 9,100,000 shares of common stock were
outstanding.
The
following description is only a summary. You should also refer to our amended
and restated certificate of incorporation and bylaws, both of which have been
filed with the SEC as exhibits to our registration statement of which this
prospectus forms a part.
Common
Stock
Each
holder of common stock is entitled to one vote for each share on all matters
submitted to a vote of the stockholders, including the election of directors,
and each holder does not have cumulative voting rights. Accordingly, the holders
of a majority of the shares of common stock entitled to vote in any election of
directors can elect all of the directors standing for election, if they so
choose.
Subject
to preferences that may be applicable to any then outstanding preferred stock,
holders of common stock are entitled to receive ratably those dividends, if any,
as may be declared from time to time by the board of directors out of legally
available funds. In the event of our liquidation, dissolution or winding up,
holders of common stock will be entitled to share ratably in the net assets
legally available for distribution to stockholders after the payment of all of
our debts and other liabilities and the satisfaction of any liquidation
preference granted to the holders of any outstanding shares of preferred
stock.
Holders
of common stock have no preemptive or conversion rights or other subscription
rights, and there are no redemption or sinking fund provisions applicable to the
common stock. All outstanding shares of common stock are, and the shares of
common stock offered by us in this offering, when issued and paid for, will be
fully paid and nonassessable. The rights, preferences and privileges of the
holders of common stock are subject to, and may be adversely affected by, the
rights of the holders of shares of any series of preferred stock which we may
designate in the future.
Preferred
Stock
The board
of directors is authorized, subject to any limitations prescribed by law,
without stockholder approval, to issue up to an aggregate of 100,000,000 shares
of preferred stock in one or more series and to fix the rights, preferences,
privileges and restrictions granted to or imposed upon the preferred stock,
including voting rights, dividend rights, conversion rights, redemption
privileges and liquidation preferences. The rights of the holders of common
stock will be subject to, and may be adversely affected by, the rights of
holders of any preferred stock that may be issued in the future. Issuance of
preferred stock, while providing flexibility in connection with possible
acquisitions and other corporate purposes, could have the effect of delaying,
deferring or preventing a change in control of INVO Bioscience. We have no
present plans to issue any shares of preferred stock.
Registration
Rights
Registration
rights with respect to shares covered by this registration statement and
prospectus –shares sold in connection with the Reserve Equity Financing
Agreement, or REF, with AGS Capital Group, LLC. In connection with establishing
the REF with AGS, we entered into a registration rights agreement with AGS.
Pursuant to the registration rights agreement, we filed a registration
statement, of which this prospectus forms a part, with the Securities and
Exchange Commission. We have agreed to use our commercially reasonable efforts
to cause this registration statement to be declared effective by the Securities
and Exchange Commission. The effectiveness of this registration statement is a
condition precedent to our ability to sell the shares of common stock subject to
this registration statement to AGS under the REF. This registration statement
covers only a portion of the shares of our common stock issuable pursuant
to the REF. We will file subsequent registration statements covering the resale
of additional shares of our common stock issuable pursuant to the REF beginning
approximately 60 days after we have substantially completed the sale to AGS
under the REF of the shares subject to this registration statement. These
subsequent registration statements are subject to our ability to prepare and
file them, and may be subject to review and comment by the Staff of the
Securities and Exchange Commission, as well as consent by our independent
registered accounting firm. Therefore, the timing of effectiveness of these
subsequent registration statements cannot be assured. The effectiveness of these
subsequent registration statements is a condition precedent to our ability to
sell the shares of common stock subject to these subsequent registration
statements to AGS under the REF.
Transfer
Agent and Registrar
We have
engaged the services of Island Stock Transfer as our transfer agent and
registrar.
We are
registering 8,790,900 shares of common stock under this prospectus on behalf of
AGS. Except as described below, to our knowledge, the selling stockholder has
not entered into any agreement, arrangement or understanding with any particular
broker or market maker with respect to the shares of common stock offered
hereby, nor, except as described below, do we know the identity of any brokers
or market makers that may participate in the sale of the shares.
The
selling stockholder may decide not to sell any shares. The selling stockholder
may from time to time offer some or all of the shares of common stock through
brokers, dealers or agents who may receive compensation in the form of
discounts, concessions or commissions from the selling stockholder and/or the
purchasers of the shares of common stock for whom they may act as agent. In
effecting sales, broker-dealers that are engaged by the selling stockholder may
arrange for other broker-dealers to participate. AGS is an “underwriter” within
the meaning of the Securities Act. Any brokers, dealers or agents who
participate in the distribution of the shares of common stock may also be deemed
to be “underwriters,” and any profits on the sale of the shares of common stock
by them and any discounts, commissions or concessions received by any such
brokers, dealers or agents may be deemed to be underwriting discounts and
commissions under the Securities Act. AGS has advised us that it may effect
resales of our common stock through any one or more registered broker-dealers.
Because the selling stockholder is deemed to be an underwriter, the selling
stockholder will be subject to the prospectus delivery requirements of the
Securities Act and may be subject to certain statutory liabilities of, including
but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5
under the Securities Exchange Act of 1934, as amended, or the Exchange
Act.
The
selling stockholder will act independently of us in making decisions with
respect to the timing, manner and size of each sale. Such sales may be made, on
the over-the-counter market, otherwise or in a combination of such methods of
sale, at then prevailing market prices, at prices related to prevailing market
prices or at negotiated prices. The shares of common stock may be sold according
to one or more of the following methods:
|
•
|
|
a
block trade in which the broker or dealer so engaged will attempt to sell
the shares of common stock as agent but may position and resell a portion
of the block as principal to facilitate the
transaction;
|
|
•
|
|
purchases
by a broker or dealer as principal and resale by such broker or dealer for
its account pursuant to this
prospectus;
|
|
•
|
|
an
over-the-counter distribution in accordance with the FINRA
rules;
|
|
•
|
|
ordinary
brokerage transactions and transactions in which the broker solicits
purchasers;
|
|
•
|
|
privately
negotiated transactions;
|
|
•
|
|
a
combination of such methods of sale;
and
|
|
•
|
|
any
other method permitted pursuant to applicable
law.
|
Any
shares covered by this prospectus which qualify for sale pursuant to Rule 144 of
the Securities Act may be sold under Rule 144 rather than pursuant to this
prospectus. In addition, the selling stockholder may transfer the shares by
other means not described in this prospectus.
Any
broker-dealer participating in such transactions as agent may receive
commissions from AGS (and, if they act as agent for the purchaser of such
shares, from such purchaser). Broker-dealers may agree with AGS to sell a
specified number of shares at a stipulated price per share, and, to the extent
such a broker-dealer is unable to do so acting as agent for AGS, to purchase as
principal any unsold shares at the price required to fulfill the broker-dealer
commitment to AGS. Broker-dealers who acquire shares as principal may thereafter
resell such shares from time to time in transactions (which may involve crosses
and block transactions and which may involve sales to and through other
broker-dealers, including transactions of the nature described above) on the
Nasdaq Capital Market, on the over-the-counter market, in privately-negotiated
transactions or otherwise at market prices prevailing at the time of sale or at
negotiated prices, and in connection with such resales may pay to or receive
from the purchasers of such shares commissions computed as described above. To
the extent required under the Securities Act, an amendment to this prospectus,
or a supplemental prospectus will be filed, disclosing:
|
•
|
|
the
name of any such broker-dealers;
|
|
•
|
|
the
number of shares involved;
|
|
•
|
|
the
price at which such shares are to be
sold;
|
|
•
|
|
the
commission paid or discounts or concessions allowed to such
broker-dealers, where applicable;
|
|
•
|
|
that
such broker-dealers did not conduct any investigation to verify the
information set out or incorporated by reference in this prospectus, as
supplemented; and
|
|
•
|
|
other
facts material to the transaction.
|
Underwriters
and purchasers that are deemed underwriters under the Securities Act may engage
in transactions that stabilize, maintain or otherwise affect the price of the
securities, including the entry of stabilizing bids or syndicate covering
transactions or the imposition of penalty bids. AGS and any other persons
participating in the sale or distribution of the shares will be subject to the
applicable provisions of the Exchange Act and the rules and regulations
thereunder including, without limitation, Regulation M. These provisions may
restrict certain activities of, and limit the timing of, purchases by the
selling stockholder or other persons or entities. Furthermore, under Regulation
M, persons engaged in a distribution of securities are prohibited from
simultaneously engaging in market making and certain other activities with
respect to such securities for a specified period of time prior to the
commencement of such distributions, subject to special exceptions or exemptions.
Regulation M may restrict the ability of any person engaged in the distribution
of the securities to engage in market-making and certain other activities with
respect to those securities. In addition, the anti-manipulation rules under the
Exchange Act may apply to sales of the securities in the market. All of these
limitations may affect the marketability of the shares and the ability of any
person to engage in market-making activities with respect to the
securities.
We have
agreed to pay the expenses of registering the shares of common stock under the
Securities Act, including registration and filing fees, printing expenses,
administrative expenses and certain legal and accounting fees. The selling
stockholder will bear all discounts, commissions or other amounts payable to
underwriters, dealers or agents, as well as transfer taxes and certain other
expenses associated with the sale of securities.
Under the
terms of the AGS common stock purchase agreement and the registration rights
agreement, we have agreed to indemnify the selling stockholder and certain other
persons against certain liabilities in connection with the offering of the
shares of common stock offered hereby, including liabilities arising under the
Securities Act or, if such indemnity is unavailable, to contribute toward
amounts required to be paid in respect of such liabilities.
At any
time a particular offer of the shares of common stock is made, a revised
prospectus or prospectus supplement, if required, will be distributed. Such
prospectus supplement or post-effective amendment will be filed with the SEC, to
reflect the disclosure of required additional information with respect to the
distribution of the shares of common stock. We may suspend the sale of shares by
the selling stockholder pursuant to this prospectus for certain periods of time
for certain reasons, including if the prospectus is required to be supplemented
or amended to include additional material information.
The
validity of the issuance of the common stock offered hereby will be passed upon
for us by Shulman, Rogers, Gandal Pordy & Ecker, P.A..
The
financial statements for the two most recent fiscal years ended December 31,
2007 and 2008, have been audited by Webb & Company, P.A. and RBSM, LLP
respectively, independent registered public accounting firms, to the extent and
for the periods set forth in their report, which contains an explanatory
paragraph regarding our ability to continue as a going concern, appearing
elsewhere herein and in the registration statement, and are included in reliance
upon such report given upon the authority of said firms as experts in auditing
and accounting.
WHER
E YOU CAN FIND ADDITIONAL INFORMATION
We have
filed with the SEC a registration statement on Form S-1 under the Securities Act
that registers the shares of our common stock to be sold in this offering. The
registration statement, including the attached exhibits and schedules, contains
additional relevant information about us and our capital stock. The rules and
regulations of the SEC allow us to omit from this prospectus certain information
included in the registration statement. For further information about us and our
common stock, you should refer to the registration statement and the exhibits
and schedules filed with the registration statement. With respect to the
statements contained in this prospectus regarding the contents of any agreement
or any other document, in each instance, the statement is qualified in all
respects by the complete text of the agreement or document, a copy of which has
been filed as an exhibit to the registration statement.
We file
reports, proxy statements and other information with the SEC under the
Securities Exchange Act of 1934. You may read and copy this information from the
Public Reference Room of the SEC, 100 F Street, N.E., Room 1580, Washington,
D.C. 20549, at prescribed rates. You may obtain information on the operation of
the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also
maintains an Internet website that contains reports, proxy statements and other
information about issuers, like us, that file electronically with the SEC. The
address of that website is www.sec.gov.
You
should rely only on the information provided in this prospectus or any
prospectus supplement. We have not authorized anyone else to provide you with
different information. We are not making an offer to sell, nor
soliciting an offer to buy, these securities in any jurisdiction where that
would not be permitted or legal. Neither the delivery of this
prospectus nor any sales made hereunder after the date of this prospectus shall
create an implication that the information contained herein or our affairs have
not changed since the date hereof.
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
IND
EX to FINANCIAL
STATEMENTS
For
the nine months ended September 30, 2009
|
|
|
|
|
F-2
|
|
F-3
|
|
F-4
|
|
F-5
|
|
F-6
|
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
CON
DENSED CONSOLIDATED BALANCE SHEETS
|
|
As
of
September
30,
2009
|
|
As
of
December
31,
2008
|
|
|
(unaudited)
|
|
|
Assets
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash
|
|
$
|
194,405
|
|
|
$
|
15,716
|
|
Accounts
receivable, net
|
|
|
66,889
|
|
|
|
34,195
|
|
Other
receivable
|
|
|
-
|
|
|
|
7,500
|
|
Inventory
|
|
|
66,545
|
|
|
|
70,722
|
|
Prepaid
expenses
|
|
|
11,250
|
|
|
|
73,785
|
|
Total
current assets
|
|
|
339,089
|
|
|
|
201,918
|
|
Property
and equipment, net
|
|
|
34,939
|
|
|
|
41,245
|
|
Other
Assets:
|
|
|
|
|
|
|
|
|
Capitalized
patents, net
|
|
|
64,167
|
|
|
|
68,392
|
|
Total
other assets
|
|
|
64,167
|
|
|
|
68,392
|
|
Total
assets
|
|
$
|
438,195
|
|
|
$
|
311,555
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders' Deficiency
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
650,193
|
|
|
$
|
226,861
|
|
Accrued
expenses and salaries
|
|
|
561,583
|
|
|
|
614,799
|
|
Notes
payable- related party
|
|
|
158,462
|
|
|
|
-
|
|
Line
of credit
|
|
|
50,000
|
|
|
|
50,000
|
|
Convertible
notes, net of debt discount of $543,023 and $0,
respectively
|
|
|
1,977
|
|
|
|
-
|
|
Derivative
liabilities
|
|
|
3,593,414
|
|
|
|
-
|
|
Total
current liabilities
|
|
|
5,015,629
|
|
|
|
891,660
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long
Term Liabilities:
|
|
|
|
|
|
|
|
|
Note
payable - related party
|
|
|
-
|
|
|
|
96,462
|
|
Total
long term liabilities
|
|
|
-
|
|
|
|
96,462
|
|
Total
liabilities
|
|
|
5,015,629
|
|
|
|
988,122
|
|
|
|
|
|
|
|
|
|
|
Commitments
and Contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
Deficiency:
|
|
|
|
|
|
|
|
|
Preferred
Stock, $.0001 par value; 100,000,000 shares authorized; no shares issued
and outstanding
|
|
|
-
|
|
|
|
-
|
|
Common
Stock, $.0001 par value; 200,000,000 shares authorized; 55,247,833
and
53,620,000
issued and outstanding as of September 30, 2009 and December 31, 2008,
respectively.
|
|
|
5,525
|
|
|
|
5,362
|
|
Additional
paid-in capital
|
|
|
2,208,353
|
|
|
|
1,855,565
|
|
Stock
subscription receivable
|
|
|
(205,000)
|
|
|
|
(450,000)
|
|
Accumulated
deficit during the development stage
|
|
|
(6,586,312
|
)
|
|
|
(2,087,494
|
)
|
Total
stockholders' deficiency
|
|
|
(4,577,434
|
)
|
|
|
(676,567
|
)
|
Total
liabilities and stockholders' deficiency
|
|
$
|
438,195
|
|
|
$
|
311,555
|
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
(A
DEVELOPMENT STAGE COMPANY)
CONDENSED
CONSOLIDATED STATEMENT OF
OPERATIONS
(unaudited)
|
|
Three
months
ended
September
30, 2009
|
|
|
Three
months
ended
September
30, 2008
|
|
|
From
January 5, 2007 (Inception) to
September
30, 2009
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product
Revenue
|
|
$
|
2,852
|
|
|
$
|
-
|
|
|
$
|
94,292
|
|
Cost
of Goods Sold:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Costs
|
|
|
3,682
|
|
|
|
1,765
|
|
|
|
40,616
|
|
Gross
Margin:
|
|
|
(830
|
)
|
|
|
(1,765
|
)
|
|
|
53,676
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
|
|
|
(17,500
|
)
|
|
|
90,061
|
|
Selling,
general and administrative
|
|
|
293,588
|
|
|
|
365,121
|
|
|
|
3,409,367
|
|
Total
Operating Expenses
|
|
|
293,588
|
|
|
|
347,621
|
|
|
|
3,499,428
|
|
Loss
from operations
|
|
|
(294,418
|
)
|
|
|
(349,386
|
)
|
|
|
(3,445,752
|
)
|
Other
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change
in fair value of derivative liability
|
|
|
380,036
|
|
|
|
|
|
|
|
380,036
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and financing expenses
|
|
|
2,734,579
|
|
|
|
1,907
|
|
|
|
2,760,524
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
other expenses
|
|
|
3,114,615
|
|
|
|
1,907
|
|
|
|
3,140,560
|
|
Loss
before income taxes
|
|
|
(3,409,033
|
)
|
|
|
(351,293
|
)
|
|
|
(6,586,312
|
)
|
Provisions
for income taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Net
Loss
|
|
$
|
(3,409,033
|
)
|
|
$
|
(351,293
|
)
|
|
$
|
(6,586,312
|
)
|
Basic
and diluted net loss per weighted average shares of common
stock
|
|
$
|
(0.06
|
)
|
|
$
|
(0.01
|
)
|
|
|
|
|
Basic
and diluted Weighted average number of shares of common
stock
|
|
|
54,114,000
|
|
|
|
36,419,937
|
|
|
|
-
|
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
(A
DEVELOPMENT STAGE COMPANY)
CONDENSED
CONSOLIDATED STATEMENT OF
OPERATIONS
(unaudited)
|
|
Nine
months ended September 30, 2009
|
|
|
Nine
months ended September 30, 2008
|
|
|
From
January 5, 2007
(Inception)
to
September
30, 2009
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product
Revenue
|
|
$
|
56,298
|
|
|
$
|
-
|
|
|
$
|
94,292
|
|
Cost
of Goods Sold:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Costs
|
|
|
30,528
|
|
|
|
1,765
|
|
|
|
40,616
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Margin:
|
|
|
25,770
|
|
|
|
(1,765
|
)
|
|
|
53,676
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
4,950
|
|
|
|
-
|
|
|
|
90,061
|
|
Selling,
general and administrative
|
|
|
1,394,592
|
|
|
|
660,875
|
|
|
|
3,409,367
|
|
Total
Operating Expenses
|
|
|
1,399,542
|
|
|
|
660,875
|
|
|
|
3,499,428
|
|
Loss
from operations
|
|
|
(1,373,772
|
)
|
|
|
(662,640
|
)
|
|
|
(3,445,752
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Change
in fair value of derivative liability
|
|
|
380,036
|
|
|
|
|
|
|
|
380,036
|
|
Interest
and financing expenses
|
|
|
2,745,010
|
|
|
|
5,933
|
|
|
|
2,760,524
|
|
Total
other expenses
|
|
|
3,125,046
|
|
|
|
5,933
|
|
|
|
3,140,560
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before income taxes
|
|
|
(4,498,818
|
)
|
|
|
(668,573
|
)
|
|
|
(6,586,312
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provisions
for income taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(4,498,818
|
)
|
|
$
|
(668,573
|
)
|
|
$
|
(6,586,312
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per weighted average shares of common
stock
|
|
$
|
(0.08
|
)
|
|
$
|
(0.02
|
)
|
|
|
|
|
Basic
and diluted Weighted average number of shares of common
stock
|
|
|
53,849,481
|
|
|
|
32,493,732
|
|
|
|
|
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
(A
DEVELOPMENT STAGE COMPANY)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
|
|
For
the nine months ended
September
30, 2009
|
|
|
For
the nine months ended
September
30, 2008
|
|
|
From
January
5, 2007
(Inception)
to
September
30, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(4,498,818
|
)
|
|
$
|
(668,573
|
)
|
|
$
|
(6,586,312
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock compensation issued for services
|
|
|
352,950
|
|
|
|
13,051
|
|
|
|
404,535
|
|
In
kind contribution to employees
|
|
|
-
|
|
|
|
160,821
|
|
|
|
251,686
|
|
Bad
debt expense
|
|
|
2,600
|
|
|
|
-
|
|
|
|
6,400
|
|
Interest
expense - related party
|
|
|
4,168
|
|
|
|
3,690
|
|
|
|
10,156
|
|
Depreciation
and amortization
|
|
|
10,531
|
|
|
|
8,952
|
|
|
|
24,192
|
|
Derivative
liabilities
|
|
|
3,050,391
|
|
|
|
-
|
|
|
|
3,050,391
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Receivables
|
|
|
(35,294
|
)
|
|
|
-
|
|
|
|
(73,289
|
)
|
Inventories
|
|
|
4,177
|
|
|
|
(22,340
|
)
|
|
|
(66,545
|
)
|
Prepaid
expenses and other
current
assets
|
|
|
70,035
|
|
|
|
(15,486
|
)
|
|
|
(23,100
|
)
|
Accounts
payable
|
|
|
423,332
|
|
|
|
112,705
|
|
|
|
649,922
|
|
Accrued
salaries
|
|
|
407,355
|
|
|
|
-
|
|
|
|
407,355
|
|
Other
accrued expense
|
|
|
(464,738)
|
|
|
|
32,123
|
|
|
|
88,626
|
|
Net
cash used in operating activities
|
|
|
(673,311
|
)
|
|
|
(375,057
|
)
|
|
|
(1,855,982
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase
of equipment
|
|
|
-
|
|
|
|
(23,801
|
)
|
|
|
(42,858
|
)
|
Purchase
of intangible assets
|
|
|
-
|
|
|
|
(20,384
|
)
|
|
|
(77,742
|
)
|
Net
cash used in investing activities
|
|
|
-
|
|
|
|
(44,185
|
)
|
|
|
(120,600
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from demand note payable
|
|
|
-
|
|
|
|
779
|
|
|
|
50,000
|
|
Proceeds
from convertible loan
|
|
|
545,000
|
|
|
|
-
|
|
|
|
545,000
|
|
Proceeds
from loan payable- insurance
|
|
|
-
|
|
|
|
-
|
|
|
|
70,587
|
|
Proceeds
from loan payable- related party
|
|
|
88,000
|
|
|
|
2,916
|
|
|
|
190,889
|
|
Repayment
of loan payable- related party
|
|
|
(26,000)
|
|
|
|
-
|
|
|
|
(32,427
|
)
|
Proceeds
from issuance of common stock
|
|
|
-
|
|
|
|
442,000
|
|
|
|
1,101,938
|
|
Proceeds
from subscription receivable
|
|
|
245,000
|
|
|
|
-
|
|
|
|
245,000
|
|
Net
cash provided by financing activities
|
|
|
852,000
|
|
|
|
445,695
|
|
|
|
2,170,987
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
increase in cash and cash equivalents
|
|
$
|
178,689
|
|
|
$
|
26,453
|
|
|
$
|
194,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at beginning of period
|
|
$
|
15,716
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at end of period
|
|
$
|
194,405
|
|
|
$
|
26,453
|
|
|
$
|
194,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of non-cash financing activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$
|
18,538
|
|
|
$
|
5,933
|
|
|
$
|
25,945
|
|
Cash
paid for taxes
|
|
$
|
456
|
|
|
$
|
-
|
|
|
$
|
456
|
|
The
accompanying notes are an integral part of these unaudited condensed
consolidated financial statements.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
NOTE 1. SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES AND ORGANIZATION
(A)
Description of
Business
INVO
Bioscience, Inc. (“the Company”) offers novel solutions in assisted reproductive
technologies while expanding geographic and affordable access to the global
reproductive health care community. Our primary focus is the
manufacture and sale of the INVOcell device and the INVO technology to assist
infertile couples in having a baby. We designed our
INVOcell device and our INVO procedure to provide an alternative infertility
treatment for the patient and the clinician. The INVO procedure is
less expensive and simpler to perform than most comparable infertility
treatments currently. The simplicity of the INVO procedure relates to
the ability to potentially perform the INVO procedure in a physician’s practice
rather than in a specialized facility at a much lower cost overall than current
infertility treatments.
We
believe that the INVO procedure will make infertility treatment more readily
available throughout the world. The INVO procedure is significantly
less costly than conventional IVF. The INVOcell device and INVO
procedure facilitates conception and embryo development inside the woman's body,
rather than in a dish in a laboratory, which is an attractive feature for most
couples.
We are a
development stage company, as defined by Accounting Standards Codification
(“ASC”) Topic 915, “Accounting and Reporting by Development Stage Enterprise”
formerly (“SFAS”) No. 7. The Company’s activities during our
development stage to date has included developing the business plan, seeking
regulatory clearance in the European Union and the United States, raising
capital, conducting beta tests, sales and marketing of the INVOcell device and
offering instructions in the INVO technique to doctors in numerous foreign
countries.
Through
September 30, 2009, we have generated minimal sales revenues, have incurred
significant expenses and have sustained losses. Consequently, our
operations are subject to all of the risks inherent in the establishment of a
new business enterprise.
In May
2008, the Company received notice that the INVOcell product meets all the
essential requirements of the relevant European Directive(s), and received CE
Marking. The CE marking (also known as CE mark) is a mandatory
conformity mark on many products placed on the single market in the European
Economic Area (EEA). The CE marking (an acronym for the French
“Conformité Européenne”) certifies that a product has met EU health, safety and
environmental requirements, which ensure consumer safety. With CE
marking, the Company possesses the regulatory authority to distribute its
product in the European Economic Area, provided we comply with local
registration requirements as discussed herein (
i.e.,
the European Union,
Canada, Australia, New Zealand and most parts of the Middle
East). The Company has sold approximately 900 INVOcell units through
September 30, 2009.
(B)
Basis
of Presentation
On
December 5, 2008, the Company completed a share exchange with Emy’s Salsa Aji
Distribution Company, Inc. (“Emy’s”), a publicly registered shell corporation
with no significant assets or operations. Emy’s was incorporated on
July 11, 2005, under the laws of the State of Nevada under the name Certiorari
Corp. In connection with the share exchange, INVO Bioscience became
Emy’s wholly-owned subsidiary and the INVO Bioscience Shareholders acquired
control of Emy’s.
The
Company accounted for the transaction as a recapitalization and the Company is
the surviving entity. In connection with the share exchange, Emy’s
shareholders retained 14,937,500 shares. Effective with the
Agreement, all previously outstanding shares of common stock owned by the
Company's shareholders were exchanged for an aggregate of 38,307,500 shares of
Emy’s common stock. Effective with the Agreement, Emy’s changed its
name to INVO Bioscience, Inc.
All
references to “common stock,” “share” and “per share” amounts have been
retroactively restated to reflect the exchange ratio of 357.0197 shares of INVO
Bioscience common stock for one share of Emy’s common stock outstanding
immediately prior to the merger as if the exchange had taken place as of the
beginning of the earliest period presented.
The
accompanying unaudited condensed consolidated financial statements present the
historical financial condition, results of operations and cash flows of the
Company prior to the merger with Emys. The accompanying unaudited
condensed consolidated financial statements present on a consolidated basis the
accounts of the Company and its wholly owned subsidiaries. All
significant intercompany accounts and transactions have been eliminated in
consolidation.
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
(C)
Significant Accounting
Policies
The
financial statements included herein have been prepared, without audit, pursuant
to the rules and regulations of the Securities and Exchange
Commission. Certain information and disclosures included in financial
statements prepared in accordance with accounting principles generally accepted
in the United States of America have been condensed or omitted pursuant to such
rules and regulations. These unaudited condensed consolidated
financial statements should be read in conjunction with the financial statements
and notes thereto included in our 2008 Annual Report filed on Form 10-K on April
15, 2009. The condensed consolidated balance sheet as of December 31,
2008 was derived from the audited financial statements for the year then
ended.
In the
opinion of the Company, all adjustments necessary to present fairly our
financial position and the results of our operations and cash flows have been
included in the accompanying unaudited condensed consolidated financial
statements. The results of operations for interim periods are not
necessarily indicative of the expected results for the year ended December 31,
2009.
Use of
Estimates
The
preparation of interim Consolidated Financial Statements in conformity with U.S.
GAAP requires us to make estimates and assumptions that affect the amounts
reported and disclosed in the financial statements and the accompanying
notes. Actual results could differ materially from these
estimates. On an ongoing basis, we evaluate our estimates, including
those related to accounts receivable, fair values of financial instruments, fair
values of intangible assets and goodwill, useful lives of intangible assets,
property, and equipment, fair values of stock-based awards, and income taxes,
among others. We base our estimates on historical experience and on
various other assumptions that are believed to be reasonable, the results of
which form the basis for making judgments about the carrying values of assets
and liabilities.
Cash and Cash
Equivalents
The
Company considers all highly liquid temporary cash investments with an original
maturity of three months or less to be cash equivalents. As of
September 30, 2009, and December 31, 2008, the Company had $194,400 and $15,700
in cash equivalents, respectively.
(D)
Effect of
Recent Accounting Pronouncements
With
the exception of those discussed below, there have been no recent accounting
pronouncements or changes in accounting pronouncements during the three and nine
months ended September 30, 2009, as compared to the recent accounting
pronouncements described in the Company’s Annual Report on Form 10-K for the
year ended December 31, 2008, that are of significance, or potential
significance to the Company.
On
July 1, 2009, the Financial Accounting Standards Board (“FASB”) launched
the FASB Accounting Standards Codification (“ASC”) 105,
Generally Accepted Accounting
Principles
(“ASC 105” and formerly referred to as FAS 168). ASC 105,
establishes the FASB Accounting Standards Codification as the source of
authoritative accounting principles recognized by the FASB to be applied by
nongovernmental entities in the preparation of financial statements in
conformity with GAAP. Rules and interpretive releases of the Securities and
Exchange Commission (SEC) under authority of federal securities laws are also
sources of authoritative GAAP for SEC registrants. ASC 105 is effective for
financial statements issued for interim and annual periods ending after
September 15, 2009.
GAAP is
not intended to be changed as a result of the FASB’s Codification project, but
it will change the way the guidance is organized and presented. As a result,
these changes will have a significant impact on how companies reference GAAP in
their financial statements and in their accounting policies for financial
statements issued for interim and annual periods ending after September 15,
2009.
In
June 2008, the FASB ratified EITF Issue No. 07-5, “Determining Whether
an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock” (EITF
07-5, included in ASC 815-40). EITF 07-5 mandates a two-step process for
evaluating whether an equity-linked financial instrument or embedded feature is
indexed to the entity’s own stock. It is effective for fiscal years beginning on
or after December 15, 2008. The adoption of EITF 07-5 had a significant
effect on our consolidated condensed financial statements (see Note
10).
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
In
June 2009, the FASB issued SFAS No. 167,
Amendments to FASB Interpretation
No. 46(R)
(“SFAS 167”). SFAS 167, which amends ASC
810-10,
Consolidation
(“ASC
810-10”), prescribes a qualitative model for identifying whether a company has a
controlling financial interest in a variable interest entity (“VIE”) and
eliminates the quantitative model prescribed by ASC 810-10. The new
model identifies two primary characteristics of a controlling financial
interest: (1) provides a company with the power to direct significant
activities of the VIE, and (2) obligates a company to absorb losses of
and/or provides rights to receive benefits from the VIE. SFAS 167
requires a company to reassess on an ongoing basis whether it holds a
controlling financial interest in a VIE. A company that holds a
controlling financial interest is deemed to be the primary beneficiary of the
VIE and is required to consolidate the VIE. SFAS 167, which is
referenced in ASC 105-10-65, has not yet been adopted into the Codification and
remains authoritative. This statement is effective for fiscal years
beginning after November 15, 2009. The Company plans to adopt
SFAS 167 effective January 1, 2010. The adoption of SFAS 167 is
not expected to have a material impact on the Company’s financial position and
results of operations.
In
June 2009, the FASB issued SFAS No. 166,
Accounting for Transfers of
Financial Assets
(“SFAS 166”). SFAS 166 removes the concept of
a qualifying special-purpose entity from ASC 860-10,
Transfers and
Servicing
(“ASC 860-10”), and removes the exception from applying ASC
810-10. This statement also clarifies the requirements for isolation
and limitations on portions of financial assets that are eligible for sale
accounting. SFAS 166, which is referenced in ASC 105-10-65, has not
yet been adopted into the Codification and remains
authoritative. This statement is effective for fiscal years beginning
after November 15, 2009. The Company plans to adopt SFAS 166
effective January 1, 2010. The adoption of SFAS 166 is not
expected to have a material impact on the Company’s financial position and
results of operations.
NOTE 2. GOING
CONCERN
As
reflected in the accompanying unaudited condensed consolidated financial
statements, the Company is in the development stage and commenced operations
December 2008. The Company had a net operating loss for the quarter
of $294,000 and a net loss of $3,409,000 and has a cumulative net
operating loss of $3,446,000 and a net loss of $6,586,000, a working capital
deficiency of $4,677,000, a stockholder deficiency of $4,577,000 and cash used
in operations of $673,000 for the nine months ended September 30,
2009. This raises substantial doubt about its ability to continue as
a going concern. The financial statements do not include any
adjustments that might be necessary if the Company is unable to continue as a
going concern. The ability of the Company to continue as a going
concern is dependent on the Company’s ability to raise additional capital and
implement its business plan.
The
Company’s development activities since inception have been financially sustained
through stockholder loans and contributions to the Company and issuance of our
common stock and convertible notes in private placements. The Company expects to
raise additional funding to continue its operations through additional loans and
issuances of additional shares of common stock and other
securities.
NOTE 3.
INVENTORY
As of
September 30, 2009 and December 31, 2008, the Company recorded the following
inventory balances:
|
|
September
30,
2009
|
|
|
December
31,
2008
|
|
Raw
Materials
|
|
$
|
-
|
|
|
$
|
-
|
|
Work
in Process
|
|
|
49,507
|
|
|
|
55,465
|
|
Finished
Goods
|
|
|
17,038
|
|
|
|
15,257
|
|
Total
Inventory
|
|
$
|
66,545
|
|
|
$
|
70,722
|
|
INVO BIOSCIENCE,
INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
NOTE 4. PROPERTY AND
EQUIPMENT
The
estimated useful lives and accumulated depreciation for furniture, equipment and
software are as follows:
|
Estimated
Useful Life
|
Molds
|
3 to 7 years
|
Computers
and Software
|
3 to 5 years
|
|
|
September
30,
2009
|
|
|
December
31,
2008
|
|
Manufacturing
Equipment- Molds
|
|
$
|
35,263
|
|
|
$
|
35,263
|
|
Accumulated
Depreciation
|
|
|
(5,387
|
)
|
|
|
(980
|
)
|
Network/IT
Equipment
|
|
|
7,595
|
|
|
|
7,595
|
|
Accumulated
Depreciation
|
|
|
(2,532
|
)
|
|
|
(633
|
)
|
|
|
$
|
34,939
|
|
|
$
|
41,245
|
|
During
the nine months ended September 30, 2009 and 2008, the Company recorded $6,307
and $0 in depreciation expense respectively.
NOTE
5. PATENTS
As of
September 30, 2009 and December 31, 2008, the Company recorded the following
patent balances:
|
|
September
30,
2009
|
|
|
December
31,
2008
|
|
Total
Patents
|
|
$
|
77,743
|
|
|
$
|
77,743
|
|
Accumulated
Amortization
|
|
|
(13,576
|
)
|
|
|
(9,351
|
)
|
Patent
costs, net
|
|
$
|
64,167
|
|
|
$
|
68,392
|
|
During
the nine months ended September 30, 2009 and 2008, the Company recorded $4,225
and $2,591, respectively in amortization expenses
NOTE
6. WORKING LINE OF CREDIT
At
September 30, 2009, the Company had a $50,000 working capital line of credit
with Century Bank with interest payable monthly at 0.24% above the bank’s prime
lending rate. On September 30, 2009, the interest rate was
3.74%. The line of credit is set to mature on May 31,
2010. At September 30, 2009 and December 31, 2008, the balance
outstanding on the line of credit was $50,000.
NOTE
7. CONVERTIBLE NOTES
During
the three months ended September 30, 2009, the Company issued convertible notes
payable (“Bridge Notes”) to investors in the aggregate amount of
$545,000. The Bridge Notes carry interest rates ranging from 10-12%
and are due in full in one year from the date of issuance. The Bridge
Notes and accrued interest are convertible into common stock of the Company at a
conversion price of $0.10 per share, subject to adjustments. In addition to the
Bridge Notes, the Company issued warrants to purchase 5,750,000 shares of the
Company’s common stock at a price of $0.20 per share (see Note
9). Pursuant to the guidance of ASC 470-20-30 (formerly referred to
as EITF 00-27), the Company valued the conversion feature of the
Bridge Notes and the warrants issued as consideration for the notes payable via
the Black-Scholes valuation method. The total fair value calculated
for the conversion feature was $1,493,710, which is recorded as a derivative
liability on the Company’s balance sheet (see note 10). Of this amount, $152,370
was allocated to the discount on the Bridge Notes and $1,341,340 was charged to
operations. The total fair value calculated for the warrants was
$1,614,948, which is recorded as a derivative liability on the Company’s balance
sheet (see note 10). Of this amount, $392,630 was allocated to the
discount on the Bridge Notes, and $1,222,318 was charged to
operations. The aggregate discount on the Bridge Notes was $545,000,
and the aggregate amount charged to operations was $2,563,658.
The
discount of $545,000 will be amortized to interest expense over the one year
term of the Bridge Notes using the effective interest method. During the three
and nine months ended September 30, 2009, the Company recorded $1,977
amortization expense of the discount on the Bridge Notes. Interest in
the aggregate amount of $6,117 was accrued on the Bridge Notes during the three
and nine months ended September 30, 2009.
INVO BIOSCIENCE,
INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
NOTE
8. NOTE PAYABLE AND OTHER RELATED PARTY TRANSACTIONS
On
September 18, 2008, the Company entered into a related party transaction with
Dr. Claude Ranoux, the President, Director and Chief Scientific Officer of the
Company. Dr. Ranoux had loaned funds to the Company to sustain its
operations since January 5, 2007 (inception). Dr. Ranoux’s total
cumulative loans at September 30, 2009 were $70,462. On March 26, 2009,
the Company and Dr. Ranoux agreed to amend the agreement to a non-convertible
note payable bearing interest at 5% per annum and extended the repayment date to
March 31, 2010. The Company and Dr. Ranoux can jointly decide to repay the
loan earlier without prepayment penalties. During the three months and
nine months ended September 30, 2009, $26,000 was repaid on the principal of the
loan.
On March
5, 2009, the Company entered into a related party transaction with Kathleen
Karloff, the Chief Executive Officer and a Director of the
Company. Ms. Karloff provided a short-term loan in the amount of
$75,000 bearing interest at 5% per annum to the Company to fund
operations. In May 2009, Ms. Karloff loaned to the Company an
additional $13,000, making her total cumulative loan $88,000 as of September 30,
2009. This note was due on September 15, 2009, which has since been
extended to March 4, 2010.
For the
three months ended September 30, 2009 and 2008, the Company recorded $14,224 and
$1,907 in interest expense respectively. Additionally, for the nine
months ended September 30, 2009 and 2008, the Company recorded $24,655 and
$5,933 in interest expense respectively, with $3,690 of the 2008 expense being
charged as an in-kind contribution.
NOTE
9. STOCKHOLDERS’ EQUITY
Common
Stock
For the
period from January 5, 2007 (inception) through December 31, 2007, Bio X Cell,
Inc., formerly a Commonwealth of Massachusetts corporation doing business as
INVO Bioscience before the merger with Emy’s, issued 70,000 shares of common
stock for $20,000, at $.2857/share. The 70,000 shares were
retroactively restated to 24,991,379 shares following the stock split on
November 12, 2008 and the subsequent share exchange on December 5,
2008.
On
December 29, 2008, the Company filed amended and restated articles
of incorporation with the Secretary of State of Nevada. The
Company’s authorized capital stock was changed from 75,000,000 shares, all
of which were shares of common stock, par value $.0001 per share, to
authorized common stock of 200,000,000 shares, par value $.0001, and
100,000,000 newly created shares of undesignated preferred stock, par value
$.0001.
On
November 7, 2008, Emy’s Board of Directors approved a 5-1 forward stock split
(the “Forward Split”) of common stock with a record date of November 10, 2008
for the Company’s issued and outstanding shares. The Forward Split
was effective on November 12, 2008. Emy’s had 12,387,500 shares of
common stock outstanding before the Forward Split and 61,937,500 shares
outstanding thereafter.
The
Company had 61,937,500 shares issued and outstanding immediately before the
Share Exchange. Pursuant to the Share Exchange Agreement, certain
shareholders of Emy’s agreed to cancel 47,000,000 shares of Emy’s common stock
and Emys agreed to issue 38,307,500 newly-issued shares of common stock to INVO
Bioscience shareholders. As of December 5, 2008, and immediately
after Closing, an aggregate of 53,245,000 shares of common stock were
outstanding, including shares issued pursuant to the Closing.
Directly
following the consummation of the Share Exchange Agreement transaction, on the
day of the Closing, we entered into the Securities Purchase Agreement with
investors pursuant to which, the investors contributed $375,000 in exchange for
375,000 shares of our common stock at a price of $1.00 per share. The
investors have piggyback registration rights that permit them to register their
common stock on any registration statement filed by the Company, as well as
anti-dilution protection per section 7.5.
As of the
Closing, Lionshare Ventures, Inc.(LSV), a shareholder in INVO
Bioscience and the Company executed a pledge agreement
between the two parties reaffirming LSV‘s original agreement dated May 18, 2008,
the outstanding balance as of the original agreement was $450,000 for shares of
common stock previously issued but not paid for noted in the Company’s financial
statements as a subscription receivable in its equity section of the balance
sheet. On June 10, 2009, the two parties executed an extension of the
time in which the balance outstanding of $205,000 was to be paid, the date is
now December 5, 2009, 775,000 shares of common stock are being held in escrow
until the balance is paid.
In the
same pledge agreement between the Company and LSV dated December 5, 2008, LSV
committed to forfeiting a maximum of 562,500 common stock shares if the Company
is required to issue additional shares of common stock per the anti-dilution
clause (section 7.5) of the Securities Purchase Agreement mentioned
previously.
INVO BIOSCIENCE,
INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
During
the period from January 1, 2008 through November 30, 2008, the Company issued an
aggregate of 4,561,641 shares of common stock for cash totaling $706,938 for
share prices ranging from $0.15 to $1.50.
In March
2008, the Company issued an aggregate of 8,488,857 shares of common stock
(net of forfeitures) for services rendered totaling $11,259. In
November 2008, the Company issued an aggregate of 265,623 shares of common stock
for services rendered totaling $40,056.
In March
2009, the Company issued an aggregate of 83,333 shares of common stock for
services rendered totaling $37,500.
During
the 3 months ended March 30, 2009, the Company received $200,000 against
the outstanding stock subscription receivable.
In April
2009, the Company received $45,000 against the outstanding stock subscription
receivable. As of September 30, 2009, $205,000 remains
outstanding.
In May
2009, the Company issued an aggregate of 125,000 shares of common stock for
services rendered totaling $15,500.
In
September 2009, the Company issued an aggregate of 1,125,000 shares of common
stock in connection with the execution by the Company of a $100,000 convertible
note as part of a bridge offering, as discussed on the
Company’s Current Reports on Form 8-K filed July 17, 2009 and
September 17, 2009. The convertible notes have a conversion price of
$0.10. This transaction triggered the anti-dilution clause of the
Securities Purchase Agreement executed on December 5, 2008 with the certain
investors. In addition, the Company took possession of the 562,500
shares pledged by Lionshare Ventures to meet this obligation, resulting in a net
issuance of 562,500 shares of common stock.
In
September 2009, the Company issued an aggregate of 857,000 shares of common
stock for services rendered totaling $299,950.
Since
January 1, 2008, the Company has signed agreements to compensate certain of its
officers, employees and service providers with common stock or options to
acquire common stock. As of December 31, 2008, a total of 857,000
shares of common stock and options to purchase an additional 440,000 shares of
common stock were agreed to be issued. As of September 30, 2009, the
Company has issued the 857,000 shares of common stock against its previously
recorded accrued liability. However, as of September 30, 2009, the
Company has terminated 70,000 of the options and promised an additional 300,000
to two employees hired during 2009 bringing the total to
670,000 as of this date. The Company has not yet adopted a
formal stock option plan and, consequently, the options to purchase 670,000
shares of common stock are deemed not yet issued.
Non-Statutory Stock
Options
The
following table summarizes the changes in stock options outstanding and the
related prices for the shares of the Company’s common stock
issued. These options were agreed to be issued in lieu of cash
compensation for services performed.
|
|
|
Options
Outstanding
|
|
Options
Exercisable
|
|
Exercise
Price
|
|
|
Number
Outstanding
|
|
|
Weighted
Average
Remaining
Contractual
Life
(Years)
|
|
Number
Exercisable
|
|
Weighted
Average
Exercise
Price
|
|
$
|
1.00
|
|
|
|
70,000
|
|
|
|
2.9
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Transactions
involving options are summarized as follows:
|
|
Number
of
Shares
|
|
|
Weighted
Average
Price
Per
Share
|
|
Outstanding
at December 31, 2007
|
|
|
-
|
|
|
$
|
-
|
|
Granted
|
|
|
140,000
|
|
|
|
1.00
|
|
Exercised
|
|
|
-
|
|
|
|
-
|
|
Canceled
or expired
|
|
|
-
|
|
|
|
-
|
|
Outstanding
at December 31, 2008
|
|
|
140,000
|
|
|
$
|
1.00
|
|
Granted
|
|
|
-
|
|
|
|
-
|
|
Exercised
|
|
|
-
|
|
|
|
-
|
|
Canceled
or expired
|
|
|
70,000
|
|
|
|
1.00
|
|
Outstanding
at September 30, 2009
|
|
|
70,000
|
|
|
$
|
1.00
|
|
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
Aggregate
intrinsic value of options outstanding and exercisable at September 30, 2009 was
$23,800. Aggregate intrinsic value represents the difference between the
Company's closing stock price on the last trading day of the fiscal period,
which was $0.34 as of September 30, 2009, and the exercise price multiplied by
the number of options outstanding. As of September 30, 2009, total
unrecognized stock-based compensation expense related to stock options was
$105,000. During the quarters ended September 30, 2009 and 2008, the
Company did not charge to operations the related expense to recognized
stock-based compensation for the above stock options.
Warrants
During
the three months ended September 30, 2009, the Company issued warrants to
purchase 5,750,000 shares of common stock pursuant to the Bridge Notes (see note
7) agreement. The warrants have an exercise price, of $0.20 per
share. The warrants are exercisable any time after the issue date,
and have a term ranging from 3 to 5 years from the date of
issuance. These warrants were valued using the guidance of ASC
470-20-30 (formerly referred to as EITF 00-27), via the Black-Scholes valuation
method resulting in a value of $1,614,948 and were recorded as a derivative
liability on the Company’s balance sheet (see note 10).
The
following table summarizes the changes in warrants outstanding and the related
prices for the shares of the Company's common stock issued to non-employees of
the Company. These warrants were granted in lieu of cash compensation for
services performed or financing expenses and in connection with placement of
convertible debentures.
Warrants
Outstanding
|
|
|
Warrants
Exercisable
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
Weighted
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
Remaining
|
|
|
Average
|
|
|
|
|
|
Remaining
|
Exercise
|
|
|
Number
|
|
|
Contractual
|
|
|
Exercise
|
|
|
Number
|
|
|
Contractual
|
Prices
|
|
|
Outstanding
|
|
|
Life
(years)
|
|
|
Price
|
|
|
Exercisable
|
|
|
Life
(years)
|
$
|
0.20
|
|
|
|
5,750,000
|
|
|
|
4.09
|
|
|
$
|
0.20
|
|
|
|
5,750,000
|
|
|
4.09
|
|
|
|
|
|
5,750,000
|
|
|
|
4.09
|
|
|
|
|
|
|
|
5.750,000
|
|
|
4.09
|
Transactions
involving warrants are summarized as follows:
|
|
Number
of Shares
|
|
|
Weighted
Average
Price
Per Share
|
|
Outstanding
at December 31, 2008
|
|
|
-
|
|
|
$
|
-
|
|
Granted
|
|
|
5,750,000
|
|
|
|
0.20
|
|
Exercised
|
|
|
-
|
|
|
|
-
|
|
Cancelled
or expired
|
|
|
-
|
|
|
|
-
|
|
Outstanding
at September 30, 2009
|
|
|
5,750,000
|
|
|
$
|
0.20
|
|
INVO BIOSCIENCE,
INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
The
estimated value of the compensatory warrants granted to non-employees in
exchange for financing expenses was determined using the Black-Scholes pricing
model and the following assumptions:
|
|
September
30,
|
|
|
|
2009
|
|
Expected
volatility
|
|
|
309-275
|
%
|
Expected
life (years)
|
|
|
3-5
|
|
Risk
free interest rate
|
|
|
0.18-0.26
|
%
|
Forfeiture
rate
|
|
|
-
|
|
Dividend
rate
|
|
|
-
|
|
NOTE 10.
DERIVATIVE LIABILITY
In June
2008, the Financial Accounting Standards Board (“FASB”) ratified Emerging Issues
Task Force (“EITF”) Issue No. 07-5, “Determining Whether an Instrument (or
Embedded Feature) Is Indexed to Entity’s Own Stock (“EITF 07-5, included in ASC
815-40”). ASC 815-40 mandates a two-step process for evaluating
whether an equity-linked financial instrument or embedded feature is indexed to
the entity’s own stock. As disclosed in Note 7, during the nine
months ended September 30, 2009, the Company entered into short term convertible
loans with attached warrants which contain a strike price adjustment
feature. Upon the Company’s adoption of ASC 815-40, this resulted in
the instruments no longer being considered indexed to the Company’s own
stock. Accordingly, adoption of ASC 815-40 changed the current
classification (from equity to liability) and the related accounting for these
warrants outstanding as of September 30, 2009. During the third
quarter of 2009, the liability was adjusted for warrants exercised and the
change in fair value of the warrants. In accordance with ASC 815-40,
a derivative liability of $3,593,414 related to the loan conversion feature and
warrants is included in our unaudited condensed consolidated balance sheet as of
September 30, 2009. During the three and nine months ended September
30, 2009, we recorded an expense of $380,000 related to the change in fair value
of the loan conversion feature and warrants. During the three and
nine months ended September 30, 2009, we recorded an expense
of $2,563,658 related to the expense in excess of the discount on
loan conversion feature and warrants.
As a
result of the adoption of ASC 815-40, the Company is required to disclose the
fair value measurements required by ASC 820 (formerly SFAS No. 157), “Fair Value
Measurements and Disclosures.” The other liabilities recorded at fair value in
the balance sheet as of September 30, 2009 are categorized based upon the level
of judgment associated with the inputs used to measure their fair value.
Hierarchical levels, defined by ASC 820 are directly related to the amount of
subjectivity associated with the inputs to fair valuations of these liabilities
are as follows:
Level 1
—
|
Inputs
are unadjusted, quoted prices in active markets for identical assets or
liabilities at the measurement date;
|
Level 2
—
|
Inputs
other than Level 1 inputs that are either directly or indirectly
observable; and
|
Level
3 —
|
Unobservable
inputs, for which little or no market data exist, therefore requiring an
entity to develop its own
assumptions.
|
The
following table summarizes the financial liabilities measured at fair value on a
recurring basis as of September 30, 2009, segregated by the level of the
valuation inputs within the fair value hierarchy utilized to measure fair
value:
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
Level
1
|
|
|
Level
2
|
|
|
Level
3
|
|
|
at
fair value
|
|
Line
of credit and Notes payable – related party Convertible
notes
|
|
$
|
208,500
|
|
|
$
|
-
|
|
|
$
|
545,000
|
|
|
$
|
753,500
|
|
Derivative
liability
|
|
|
-
|
|
|
|
-
|
|
|
|
3,593,400
|
|
|
|
3,593,400
|
|
Total
|
|
$
|
208,500
|
|
|
$
|
-
|
|
|
$
|
4,138,400
|
|
|
$
|
4,346,900
|
|
INVO BIOSCIENCE,
INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
In
accordance with EITF 07-5, we calculated the fair value of the loan conversion
features and warrants using the Black–Scholes–Merton valuation
model. The assumptions used in the Black-Scholes-Merton valuation
model were as follows:
|
|
September
30,
|
|
|
|
2009
|
|
Expected
volatility
|
|
|
309-275
|
%
|
Expected
life (years)
|
|
|
3-5
|
|
Risk
free interest rate
|
|
|
0.18-0.26
|
%
|
Forfeiture
rate
|
|
|
-
|
|
Dividend
rate
|
|
|
-
|
|
Expected
volatility is based primarily on historical volatility. Historical volatility
was computed using daily pricing observations for the recent two
years. The Company believes this method produces an estimate that is
representative of the Company’s expectations of future volatility over the
expected term of the notes and warrants. The Company currently has no reason to
believe future volatility over the expected remaining life of the notes and
warrants is likely to differ materially from historical volatility. The expected
life is based on the remaining term of the notes and warrants. The risk-free
interest rate is based on U.S. Treasury securities according to the remaining
term of the notes and warrants. The Company has not, and does not intend to,
issue dividends; therefore, the dividend yield assumption is 0.
NOTE 11.
INCOME TAXES
The
Company has adopted Accounting Standard Codification (“ASC”) Topic 740, formerly
Financial Accounting Standard (“FAS”) 109 that requires the recognition of
deferred tax liabilities and assets for the expected future tax consequences of
events that have been included in the financial statement or tax
returns. Topic 740 determines deferred tax liabilities and assets
based on the difference between financial statements and tax basis of assets and
liabilities using enacted tax rates in effect for the year in which the
differences are expected to reverse. Temporary differences between
taxable income reported for financial reporting purposes and income tax purposes
are insignificant.
For
income tax reporting purposes, the Company's aggregate unused net operating
losses (“NOL”) of approximately $3,400,000, expire at various times through
2029, subject to limitations of Section 382 of the Internal Revenue Code of
1986, as amended. The deferred tax asset related to the NOL
carryforward is approximately $540,000. The Company has provided a
valuation reserve against the full amount of the net operating loss benefit,
since in the opinion of management based upon the earning history of the
Company, it is more likely than not that the benefits will not be
realized.
NOTE
12. COMMITMENTS
On
January 1, 2007, the Company entered into an operating lease (the “lease”) with
Cummings Properties, LLC, to lease 3,294 square feet of general office
space. The lease commenced on January 1, 2007 and was automatically
extended in October 2008 until December 31, 2010. The Company agreed
to pay a security deposit of $3,000 on January 1, 2007, which was repaid to the
Company in equal $500 installments over the first six months of the
lease. The Company received no rent incentives or improvement
allowances under this agreement. The lease requires the Company to
pay minimum lease payments of $2,000 per month for the duration of the
lease. The lease is subject to a cost of living increase equal to the
Boston, MA Consumer Price Index at the beginning of each calendar
year. As of January 1, 2009, the Company’s lease payments under this
agreement increased 3.53% to $2,070.60.
On
December 5, 2008 in conjunction with the closing of the Share Exchange
Agreement, the Company signed a letter agreement with Lionshare Ventures LLC
(“LSV”). As part of the letter agreement, LSV agreed to invest the
balance of its original commitment to the Company effective as of May 19, 2008
for $450,000. Thereafter, 2,000,000 shares of common stock were
escrowed pending LSV’s tendering of this amount to the Company. As of
September 30, 2009, LSV has delivered $245,000 to the Company and the Company
has released 1,225,000 of the 2,000,000 common shares it held in
escrow. On June 10, 2009, the Company and LSV agreed to extend the
time period until December 5, 2009 in which LSV has to deliver the outstanding
balance of $205,000.
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
On March
10, 2009, the Company entered into an agreement with Wakabayashi Fund, LLC of
Tokyo, Japan for investor relation services focused on the Asian financial
markets. This agreement has expired as of September 30, 2009.
On April
17, 2009, the Company entered into an agreement with Red Chip Securities, Inc.
of Alpharetta, Georgia to act as the Company’s investment banker and placement
agent in assisting the Company in securing a private placement equity
financing. In May 2009, Red Chip Securities ceased operations and its
members joined Moody Capital, Inc. This agreement has expired as of
September 30, 2009.
On
June 5, 2009, the Company engaged Hallmark Investments, Inc. for 90 days to act
as its placement agent on an exclusive basis in connection a private placement
bridge offering of convertible promissory notes for an aggregate principal
amount of up to $500,000. On July 15, 2009, the Company consummated
the initial closing in the total principal amount of $100,000 to one accredited
investor. The Company continued to consummate additional closings for
the bridge offering over the next 60 days as reported in its Current Report 8-K
filed September 17, 2009. This agreement has expired as of September 30,
2009.
On
September 1, 2009, the Company entered into a written agreement with
CollegeStock, Inc. (“CollegeStock”) for certain investor relations
services. The Company’s one-year agreement with
CollegeStock entitles the Company, in part, to: a detailed profile of the
Company on the CollegeStock website, a minimum of one 60 second placement
featuring client on the Wide World of Stocks television show, a detailed “Stock
Wiki” featured on www.Wikinvest.com for the duration of the agreement,
management of the Company’s twitter feed and other social networking outlets,
and branding and advertising of the Company on the homepage of CollegeStock.com,
for the duration of the agreement. As compensation for the services,
the Company has agreed to pay a retainer of 1,000,000 shares of common stock,
50% of which was due upon the signing of the agreement and the remainder is due
by March 1, 2010.
On
September 24, 2009, the Company engaged Gilford Securities, Inc. for a period of
60 days to act as its placement agent on a non-exclusive basis in connection
with a proposed Reserve Equity Financing of securities by AGS Capital Group, LLC
of up to $10,000,000. The Company reported this agreement in its
Current Report on Form 8-K filed November 2, 2009.
|
C)
|
Anti-Dilution
and Piggyback Registration Rights
|
The
Securities Purchase Agreement we entered into on December 5, 2008, granted
certain investors piggyback registration rights that permit them to register
their common stock on certain registration statements filed by the
Company. In addition, pursuant to certain anti-dilution rights granted
under the Securities Purchase Agreement to the investors, the Company may be
obligated to issue additional shares of its common stock to the investors in the
event it issues common stock to future investors at a per share purchase price
less than $1.00. The number of additional shares to be issued in such
event is equal to that number of shares that the investors would have acquired
at such price had that price been offered at the time of their original
investment, minus the number of shares acquired in their original
investment. Further, pursuant to the letter agreement, LSV and its
managing member, Christopher Esposito, have agreed to forfeit to us, one share
of our common stock for every two shares we would be required to issue up to the
maximum of 562,500 shares, which are being held in escrow by the Company until
December 5, 2010.
As
discussed above, in July 2009, the Company executed a $100,000 convertible note
in connection with the initial closing of its bridge offering (discussed in Note
7), which has a conversion price of $0.10. The conversion price
triggered the anti-dilution clause contained in the Securities Purchase
Agreement entered into with previous investors. In September 2009,
the Company issued 1,125,000 shares of common stock to
the investors that were parties to the Securities Purchase
Agreement. In addition, the Company took possession and
cancelled the 562,500 shares pledged by LSV.
Since
January 1, 2008, the Company has signed nine employee agreements for officers,
executives and employees of the Company. Three of these agreements
were with the founders of the Company. The remaining six of the
agreements were executed with executives and staff of the
Company. The Company agreed to issue options and shares of common
stock of the Company. Under the terms of these agreements, the shares
and options are only issued the completion of the share exchange and the
implementation of the Company’s employee stock plan. The share exchange
closed on December 5, 2008, however, the Company has not yet implemented an
employee stock plan. The Company intends to implement an
employee stock plan within the next 9 months. As of September 30,
2009, options to purchase an additional 670,000 shares of the Company’s common
stock have been promised but not issued. In addition, in view of the
fact that the Company has not yet adopted a formal stock option plan, these
options to purchase shares of common stock are deemed not yet
issued.
INVO BIOSCIENCE,
INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
NOTE 13. SUBSEQUENT
EVENT
Management
has reviewed and evaluated material subsequent events from the balance sheet
date of September 30, 2009 through the financial statements issue date of
November 16, 2009. All appropriate subsequent event disclosures, if any, have
been made in notes to our Unaudited Condensed Consolidated Financial
Statements.
On
October 28, 2009, the Company entered into a Reserve Equity Financing Agreement
(“REF”) with AGS Capital Group, LLC (“AGS”), pursuant to which AGS committed to
purchase, from time-to-time over a period of two years, shares of our common
stock for cash consideration up to $10,000,000, subject to certain conditions
and limitations. In connection with the REF, we also entered into a
registration rights agreement with AGS, dated October 28, 2009.
The
following is a summary of the REF and the registration rights agreement, is not
complete, and is qualified in its entirety by reference to the full text of
those agreements, each of which are incorporated by reference into this
Quarterly Report on Form 10-Q from the Current Report on Form 8-K filed on
November 2, 2009. Readers should review those agreements for a complete
understanding of the terms and conditions associated with this
financing.
Reserve Equity Financing
Agreement
For a
period of 24 months from the effectiveness of a registration statement filed
pursuant to the registration rights agreement (the “Registration Statement”), we
may, from time to time, at our discretion, and subject to certain conditions
that we must satisfy, draw down funds under the REF by selling shares of our
common stock to AGS. The purchase price of these shares will be 92% of the
“VWAP” of the common stock during the five consecutive trading days after we
give AGS a notice of an advance of funds (an “Advance”) under the REF (the
“Pricing Period”). “VWAP” generally means, as of any date, the daily dollar
volume weighted average price of our common stock as reported by Bloomberg, L.P.
or comparable financial news service. The amount of an Advance will
automatically be reduced by 50% if on any day during the Pricing Period, the
VWAP for that day does not meet or exceed 85% of the VWAP for the five trading
days prior to the notice of Advance (the “Floor Price”). The REF does not
prohibit the Company from raising additional debt or equity financings, other
than financings similar to the REF.
Our
ability to require AGS to purchase our common stock is subject to various
limitations. The maximum amount of each Advance is 100% of the average daily
trading volume for the five days immediately preceding the notice of Advance, as
reported by Bloomberg or comparable financial news service (the “Maximum Advance
Amount”). In addition, unless AGS agrees otherwise, a minimum of five
calendar days must elapse between each notice of Advance.
In
addition, before AGS is obligated to buy any shares of our common stock pursuant
to a notice of Advance, the following conditions, none of which is in AGS’s
control, must be met:
·
|
The
Company shall have filed with the SEC a Registration Statement with
respect to the resale of the shares of common stock issued to AGS in
accordance with and subject to the terms of the registration rights
agreement.
|
·
|
The
Company shall have obtained all permits and qualifications required by any
applicable state in accordance with the registration rights agreement for
the offer and sale of the shares of common stock, or shall have the
availability of exemptions therefrom. The sale and issuance of the shares
of common stock shall be legally permitted by all laws and regulations to
which the Company is subject.
|
·
|
There
shall not be any fundamental changes to the information set forth in the
Registration Statement which are not already reflected in a post-effective
amendment to the Registration Statement.
|
·
|
The
Company shall have performed, satisfied and complied in all material
respects with all covenants, agreements and conditions required by the REF
agreement and the registration rights agreement to be performed, satisfied
or complied with by the Company.
|
·
|
No
statute, rule, regulation, executive order, decree, ruling or injunction
shall have been enacted, entered, promulgated or endorsed by any court or
governmental authority of competent jurisdiction that prohibits the
consummation of or which would materially modify or delay any of the
transactions contemplated by the REF agreement, and no proceeding shall
have been commenced that may have the effect of prohibiting the
consummation of or materially modify or delay any of the transactions
contemplated by the REF Agreement.
|
INVO BIOSCIENCE,
INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
·
|
The
common stock is trading on a principal market (as defined in the REF, and
including the OTC Bulletin Board). The trading of the common stock is not
suspended by the SEC or the principal market. The issuance of shares of
common stock with respect to the applicable closing will not violate the
shareholder approval requirements of the principal market. The Company
shall not have received any notice threatening the continued quotation of
the common stock on the principal market and the Company shall have no
knowledge of any event which would be more likely than not to have the
effect of causing the common stock to not be trading or quoted on a
principal market.
|
·
|
The
amount of an Advance shall not exceed the Maximum Advance Amount. In no
event shall the number of shares issuable to AGS pursuant to an Advance
cause the aggregate number of shares of common stock beneficially owned by
AGS and its affiliates to exceed 4.99% of the then outstanding shares of
common stock of the Company (“
Ownership
Limitation
”). Any portion of an Advance that would cause AGS exceed
the Ownership Limitation shall automatically be withdrawn. For the
purposes of this provision, beneficial ownership is calculated in
accordance with Section 13(d) of the Exchange Act.
|
·
|
The
Company has no knowledge of any event which would be more likely than not
to have the effect of causing such Registration Statement to be suspended
or otherwise ineffective at Closing.
|
·
|
AGS
shall have received an Advance notice executed by an officer of the
Company and the representations contained in such Advance notice shall be
true and correct.
|
There is
no guarantee that we will be able to meet the foregoing conditions or any other
conditions under the REF agreement or that we will be able to draw down any
portion of the amounts available under the REF.
There is
no contractual limit to the number of shares that we may be required to issue to
obtain funds from the REF as it is dependent upon our share price, which varies
from day to day. If we draw down amounts under the REF when our share price is
decreasing, we will need to issue more shares to raise the same amount than if
our stock price was higher. This could cause downward pressure on the price of
our common stock.
The
Company currently intends to issue and register approximately 8,100,000 shares
of common stock under the REF. The entire share requirement for the full
$10,000,000 would be approximately 21,505,000 based on current market
prices. However, the Company has decided to limit itself to 8,100,000
shares available, or $3,756,500, based on current market prices. If the
Company’s share price rises, the Company will be able to draw down in excess of
$3,800,000. If the Company decides to issue more than 8,100,000 shares, we will
need to file an additional registration statement with the SEC covering those
additional shares.
The REF
contains representations and warranties of the Company and AGS which are typical
for transactions of this type. AGS agreed that during the term of the REF,
neither AGS nor any of its affiliates, nor any entity managed or controlled by
it, will, or cause or assist any person to, enter into or execute any short sale
of any shares of our common stock as defined in Regulation SHO promulgated under
the Exchange Act. The representations and warranties made by the
Company in the REF are qualified by reference to certain exceptions contained in
disclosure schedules delivered to AGS. The REF also contains a variety of
covenants on the part of the Company which are typical for transactions of this
type, as well as the obligation, without the prior written consent of AGS, not
to enter into any other equity line of credit agreement with a third party
during the term of the REF.
The REF
obligates the Company to indemnify AGS for certain losses resulting from a
misrepresentation or breach of any representation or warranty made by the
Company or breach of any obligation of the Company. AGS also indemnifies the
Company for similar matters.
The
Company paid no fees, and is not obligated to pay any fees in the future, in
connection with the REF, other than a due diligence fee of $10,000, all of which
has been paid as of the date hereof.
The
Company may terminate the REF effective upon fifteen trading days’ prior written
notice to AGS; provided that (i) there are no Advances outstanding, and
(ii) the Company has paid all amounts owed to AGS pursuant to the REF. The
obligation of AGS to make an Advance to the Company pursuant to the REF shall
terminate permanently if (i) there shall occur any stop order or suspension
of the effectiveness of the Registration Statement for an aggregate of fifty
(50) trading days or (ii) the Company shall at any time fail
materially to comply with certain covenants specified in the REF and such
failure is not cured within thirty (30) days after receipt of written
notice from AGS, subject to exceptions.
INVO BIOSCIENCE,
INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2009
(unaudited)
Registration Rights
Agreement
The
shares of common stock that may be issued to AGS under the REF will be issued
pursuant to an exemption from registration under the Securities Act of 1933, as
amended, or the Securities Act of 1933, as amended (the “Securities Act”).
Pursuant to the registration rights agreement, we will file a registration
statement, covering the possible resale by AGS of the shares that we may issue
to AGS under the REF (the “Registration Statement”). The Registration Statement
may cover only a portion of the total shares of our common stock issuable
pursuant to the REF with AGS. We may file subsequent Registration Statements
covering the resale of additional shares of our common stock issuable pursuant
to the REF. As described above, the effectiveness of this
Registration Statement is a condition precedent to our ability to sell common
stock to AGS under the REF. We intend to file the Registration Statement within
30-45 days from the date hereof.
P
lacement
Agent
The
Company engaged Gilford Securities, Inc. (“Gilford”) to act as its placement
agent on a nonexclusive basis in connection with the REF. Gilford
will receive a cash commission equaling six percent (6%) of the total proceeds
received by the Company from the sale of securities sold to AGS. In
addition, the Company is to issue and sell to Gilford and/or its designees, for
a total cost of one dollar ($1.00), 600,000 shares of common stock of the
Company. If the Company elects to have a closing under the REF on
more than $6,000,000, then the Company shall issue and sell to Gilford and/or
its designees, for a total cost of one dollar ($1), an additional 400,000 shares
of common stock of the Company.
The
Company will pay all reasonable expenses, not to exceed $10,000, incurred by
Gilford in connection with the negotiation, preparation and execution of the
definitive documents, including but not limited to attorneys’ fees and
consulting expenses in two installments. The first installment of
$5,000 was paid upon execution of the definitive documents and the balance will
be due upon the first funding under the REF based on actual
expenses. The placement agent agreement also contains customary
mutual indemnification provisions.
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
Board of
Directors
INVO
Bioscience, Inc.
Beverly,
MA
We have
audited the accompanying consolidated balance sheet of INVO Bioscience, Inc.
(“the Company”) , a development stage company, as of December 31,
2008, and the related consolidated statements of
losses, stockholders' deficiency, and cash flows for the year ended
December 31, 2008 and the period January 5, 2007 (date of inception) through
December 31, 2008. These financial statements are the responsibility
of the Company's management. Our responsibility is to express an
opinion on the financial statements based upon our audit.
We
conducted our audit in accordance with standards of the Public Company
Accounting Oversight Board (United States of America). Those
standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material
misstatements. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial
reporting. Our audit included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An
audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement
presentation. We believe our audit provide a reasonable basis for our
opinion.
In our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Invo Bioscience, Inc. a
development stage company, at December 31, 2008 and the results of its
operations and its cash flows for the year ended December 31, 2008 and for the
period January 5, 2007 (date of inception) through December 31, 2008 in
conformity with accounting principles generally accepted in the United States of
America.
The
accompanying consolidated financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 2,
the Company has a generated negative cash outflows from operating activities,
experienced recurring net operating losses, and is dependent on securing
additional equity and debt financing to support its business
efforts. These factors raise substantial doubt about the Company's
ability to continue as a going concern. Management's plans in regards
to this matter are described in Note 2. The consolidated financial
statements do not include any adjustments that might result from the outcome of
this uncertainty.
/s/
RBSM LLP
RBSM
LLP
New York,
New York
April 15,
2009
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors of:
BioXcell,
Inc.
We have
audited the accompanying balance sheet of BioXcell, Inc. (A Development Stage
Company) as of December 31, 2007, and the related statements of operations,
changes in stockholders’ equity and cash flows for the period January 5, 2007
(Inception) to December 31, 2007. These financial statements are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these financial statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An audit includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe
that our audit provides a reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly in all
material respects, the financial position of BioXcell, Inc. (A Development Stage
Company) as of December 31, 2007 and the results of its operations and its cash
flows for the period January 5, 2007 (Inception) to December 31, 2007 in
conformity with accounting principles generally accepted in the United States of
America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 2 to the financial
statements, the Company is in the development stage with no operations and has a
net loss of $214,089, stockholders’ deficiency of $100,926, and cash used in
operations of $116,041 for the period from January 5, 2007 (inception) to
December 31, 2007. This raises substantial doubt about its ability to
continue as a going concern. These factors raise substantial doubt
about the Company's ability to continue as a going
concern. Management's plans concerning these matters are also
described in Note 2. The financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
WEBB
& COMPANY, P.A.
Certified
Public Accountants
Boynton
Beach, Florida
November
6, 2008, except for Note 8, to which the date is December 10,
2008
|
(A
DEVELOPMENT STAGE COMPANY)
|
Consolidated
Balance Sheets
|
|
Assets
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash
|
|
$
|
15,716
|
|
|
$
|
-
|
|
Accounts
receivable
|
|
|
34,195
|
|
|
|
|
|
Other
receivable
|
|
|
7,500
|
|
|
|
|
|
Inventory
|
|
|
70,722
|
|
|
|
-
|
|
Prepaid
expenses
|
|
|
73,785
|
|
|
|
3,349
|
|
Total
current assets
|
|
|
201,918
|
|
|
|
3,349
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
41,245
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Other
Assets:
|
|
|
|
|
|
|
|
|
Deferred
financing costs, net
|
|
|
-
|
|
|
|
9,153
|
|
Capitalized
patents, net
|
|
|
68,392
|
|
|
|
43,270
|
|
Total
other assets
|
|
|
68,392
|
|
|
|
52,423
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
311,555
|
|
|
$
|
55,772
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders' Deficiency
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
226,861
|
|
|
$
|
10,351
|
|
Accrued
expenses
|
|
|
614,799
|
|
|
|
3,581
|
|
Line
of credit
|
|
|
50,000
|
|
|
|
49,221
|
|
Total
current liabilities
|
|
|
891,660
|
|
|
|
63,153
|
|
|
|
|
|
|
|
|
|
|
Long
Term Liabilities:
|
|
|
|
|
|
|
|
|
Note
payable- related party
|
|
|
96,462
|
|
|
|
93,545
|
|
Total
long term liabilities
|
|
|
96,462
|
|
|
|
93,545
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
988,122
|
|
|
|
156,698
|
|
|
|
|
|
|
|
|
|
|
Commitments
and Contingencies
|
|
|
|
|
|
|
|
|
Stockholders'
Deficiency:
|
|
|
|
|
|
|
|
|
Preferred
Stock, $.0001 par value; 100,000,000 shares authorized;
No
shares issued and outstanding as of December 31, 2008 and
2007
|
|
|
-
|
|
|
|
-
|
|
Common
Stock, $.0001 par value; 200,000,000 shares authorized; 53,620,000 and
24,991,379 issued
and
outstanding as of December 31, 2008 and 2007,
respectively.
|
|
|
5,362
|
|
|
|
2,499
|
|
Additional
paid-in capital
|
|
|
1,855,565
|
|
|
|
110,664
|
|
Stock
subscription receivable
|
|
|
(450,000)
|
|
|
|
-
|
|
Accumulated
deficit during the development stage
|
|
|
(2,087,494
|
)
|
|
|
(214,089
|
)
|
Total
stockholders' deficiency
|
|
|
(676,567
|
)
|
|
|
(100,926
|
)
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' deficiency
|
|
$
|
311,555
|
|
|
$
|
55,772
|
|
The
accompanying notes are an integral part of these consolidated financial
statements.
|
|
(A
DEVELOPMENT STAGE COMPANY)
|
|
Consolidated
Statements of Losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
|
|
|
From
January 5, 2007
|
|
|
From
January 5, 2007
|
|
|
|
Ended
|
|
|
(Inception)
to
|
|
|
(Inception)
to
|
|
|
|
December 31,
2008
|
|
|
December 31,
2007
|
|
|
December 31,
2008
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product
Revenue
|
|
$
|
37,995
|
|
|
$
|
-
|
|
|
$
|
37,995
|
|
Cost
of Goods Sold:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Costs
|
|
|
10,088
|
|
|
|
|
|
|
|
10,088
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Margin:
|
|
|
27,907
|
|
|
|
|
|
|
|
27,907
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
51,761
|
|
|
|
33,350
|
|
|
|
85,111
|
|
Selling,
general and administrative
|
|
|
1,837,606
|
|
|
|
177,170
|
|
|
|
2,014,776
|
|
Total
Operating Expenses
|
|
|
1,889,367
|
|
|
|
210,520
|
|
|
|
2,099,887
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(1,861,460
|
)
|
|
|
(210,520
|
)
|
|
|
(2,071,980
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
11,945
|
|
|
|
3,569
|
|
|
|
15,514
|
|
Total
other expenses
|
|
|
11,945
|
|
|
|
3,569
|
|
|
|
15,514
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before income taxes
|
|
|
(1,873,405
|
)
|
|
|
(214,089
|
)
|
|
|
(2,087,494
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provisions
for income taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(1,873,405
|
)
|
|
$
|
(214,089
|
)
|
|
$
|
(2,087,494
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted net loss per weighted average shares of common
stock
|
|
$
|
(0.05
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
|
|
Basic
and diluted Weighted average number of shares of common
stock
|
|
|
36,691,176
|
|
|
|
24,649031
|
|
|
|
|
|
The
accompanying notes are an integral part of these consolidated financial
statements.
|
|
Consolidated
Statement of Stockholders' Deficiency
|
|
For
the Period January 5, 2007 (Date of Inception) to December 31,
2008
|
|
|
|
|
|
Common
Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Additional
Paid in Capital
|
|
|
Subscription
Receivable
|
|
Accumulated
Deficit
during Development Stage
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
issuance to founder in January 2007
|
|
|
24,991,379
|
|
|
$
|
2,499
|
|
|
$
|
17,501
|
|
|
|
|
|
-
|
|
|
$
|
20,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In
Kind contribution of services in December 2007
|
|
|
-
|
|
|
|
-
|
|
|
|
90,865
|
|
|
|
|
|
-
|
|
|
|
90,865
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In
Kind contribution of interest in December 2007
|
|
|
-
|
|
|
|
-
|
|
|
|
2,298
|
|
|
|
|
|
-
|
|
|
|
2,298
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss for the period January 5, 2007 (Inception)to December 31,
2007
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
$
|
(214,089
|
)
|
|
|
(214,089
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2007
|
|
|
24,991,379
|
|
|
$
|
2,499
|
|
|
$
|
110,664
|
|
|
|
|
$
|
(214,089
|
)
|
|
$
|
(100,926
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for services in
March
2008
|
|
|
10,728,442
|
|
|
|
1,073
|
|
|
|
11,978
|
|
|
|
|
|
-
|
|
|
|
13,051
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for cash in April 2008
|
|
|
312,392
|
|
|
|
31
|
|
|
|
31,969
|
|
|
|
|
|
-
|
|
|
|
32,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for cash in May 2008
|
|
|
365,588
|
|
|
|
37
|
|
|
|
54,963
|
|
|
|
|
|
-
|
|
|
|
55,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for cash in June 2008
|
|
|
431,994
|
|
|
|
43
|
|
|
|
64,957
|
|
|
|
|
|
-
|
|
|
|
65,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for cash in July 2008
|
|
|
399,148
|
|
|
|
40
|
|
|
|
59,960
|
|
|
|
|
|
-
|
|
|
|
60,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for cash in
A
ugust
2008
|
|
|
365,588
|
|
|
|
37
|
|
|
|
54,963
|
|
|
|
|
|
-
|
|
|
|
55,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for cash in September 2008
|
|
|
1,136,751
|
|
|
|
114
|
|
|
|
174,886
|
|
|
|
|
|
-
|
|
|
|
175,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In
Kind Contribution of services in September 2008
|
|
|
-
|
|
|
|
-
|
|
|
|
160,821
|
|
|
|
|
|
-
|
|
|
|
160,821
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In
Kind Contribution of interest in September 2008
|
|
|
-
|
|
|
|
-
|
|
|
|
3,690
|
|
|
|
|
|
-
|
|
|
|
3,690
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for cash in
October
2008
|
|
|
1,118,186
|
|
|
|
112
|
|
|
|
199,826
|
|
|
|
|
|
-
|
|
|
|
199,938
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for services in November 2008
|
|
|
265,623
|
|
|
|
27
|
|
|
|
40,029
|
|
|
|
|
|
-
|
|
|
|
40,056
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
common stock for services not fully rendered during 2008
|
|
|
(2,239,585
|
)
|
|
|
(224
|
)
|
|
|
(1,568
|
)
|
|
|
|
|
-
|
|
|
|
(1,792
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for cash in November 2008
|
|
|
431,994
|
|
|
|
43
|
|
|
|
64,957
|
|
|
|
|
|
-
|
|
|
|
65,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued to Registrant’s shareholders in December 2008
|
|
|
14,937,500
|
|
|
|
1,494
|
|
|
|
448,506
|
|
|
(450,000
|
)
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued for Cash in December 2008
|
|
|
375,000
|
|
|
|
38
|
|
|
|
374,962
|
|
|
|
|
|
-
|
|
|
|
375,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss, for the year ended
December
31, 2008
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
-
|
|
$
|
(1,873,405
|
)
|
|
|
(1,873,405
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
December 31, 2008
|
|
|
53,620,000
|
|
|
$
|
5,362
|
|
|
$
|
1,855,565
|
|
$
|
(450,000
|
)
|
$
|
(2,087,494
|
)
|
|
$
|
(676,567
|
)
|
The
accompanying notes are an integral part of these consolidated financial
statements.
|
|
(A
DEVELOPMENT STAGE COMPANY)
|
|
Consolidated
Statements of Cash Flows
|
|
|
|
|
|
For
the Year
|
|
|
From
January 5, 2007
|
|
|
From
January 5, 2007
|
|
|
|
Ended
December
31, 2008
|
|
|
(Inception)
to December 31,
2007
|
|
|
(Inception)
to December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(1,873,405
|
)
|
|
$
|
(214,089
|
)
|
|
$
|
(2,087,494
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock compensation issued for services
|
|
|
51,585
|
|
|
|
-
|
|
|
|
51,585
|
|
In
kind contribution to employees
|
|
|
160,821
|
|
|
|
90,865
|
|
|
|
251,686
|
|
In
kind interest on loan payable- related party
|
|
|
3,690
|
|
|
|
2,298
|
|
|
|
5,988
|
|
Depreciation
and amortization
|
|
|
7,509
|
|
|
|
6,152
|
|
|
|
13,661
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Receivables
|
|
|
(41,695
|
)
|
|
|
-
|
|
|
|
(41,695
|
)
|
Inventories
|
|
|
(70,721
|
)
|
|
|
-
|
|
|
|
(70,721
|
)
|
Prepaid
expenses and other current assets
|
|
|
(70,436
|
)
|
|
|
(15,199
|
)
|
|
|
(85,635
|
)
|
Accounts
payable
|
|
|
216,240
|
|
|
|
10,351
|
|
|
|
226,591
|
|
Other
accrued expenses
|
|
|
549,784
|
|
|
|
3,581
|
|
|
|
553,365
|
|
Net
cash used in operating activities
|
|
|
(1,066,629
|
)
|
|
|
(116,041
|
)
|
|
|
(1,182,670
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase
of property and equipment
|
|
|
(42,858
|
)
|
|
|
-
|
|
|
|
(42,858
|
)
|
Purchase
of intangible assets
|
|
|
(31,017
|
)
|
|
|
(46,725
|
)
|
|
|
(77,742
|
)
|
Net
cash used in investing activities
|
|
|
(73,875
|
)
|
|
|
(46,725
|
)
|
|
|
(120,600
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from demand note payable
|
|
|
779
|
|
|
|
49,221
|
|
|
|
50,000
|
|
Proceeds
from loan payable- insurance
|
|
|
70,587
|
|
|
|
-
|
|
|
|
70,587
|
|
Proceeds
from loan payable- related party
|
|
|
9,344
|
|
|
|
93,545
|
|
|
|
102,889
|
|
Repayment
of loan payable- related party
|
|
|
(6,428
|
)
|
|
|
-
|
|
|
|
(6,24
|
8)
|
Proceeds
from the issuance of common stock
|
|
|
1,081,938
|
|
|
|
20,000
|
|
|
|
1,101,938
|
|
Net
cash provided by financing activities
|
|
|
1,156,221
|
|
|
|
162,766
|
|
|
|
1,318,986
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
increase in cash and cash equivalents
|
|
|
15,716
|
|
|
|
-
|
|
|
|
15,716
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at beginning of period
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents at end of period
|
|
|
15,716
|
|
|
|
-
|
|
|
|
15,716
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of non-cash financing activity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
|
8,255
|
|
|
|
1,243
|
|
|
|
9,498
|
|
Cash
paid for taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
The
accompanying notes are an integral part of these consolidated financial
statements.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
as
of DECEMBER 31, 2008 and DECEMBER 31, 2007
NOTE
1
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES AND
ORGANIZATION
|
(A) General
INVO
Bioscience, Inc. (“the Company”) intends to commercialize its proven and
patented technology that will revolutionize the treatment of
infertility. The Company’s device, the INVOcell and the INVO
procedure are designed to be simple for the patient and the clinician, less
expensive and simpler to perform than conventional in vitro
fertilization. The simplicity of INVO means that it may be performed
in a physician’s practice and therefore it will be available in many more
locations than conventional IVF. INVO also allows conception and
embryo development to take place inside the woman's body; an attractive feature
for most women.
We are a
development stage company, as defined by Statement of Financial Accounting
Standards (“SFAS”) No. 7. The Company’s Activities during the
development stage include developing the business plan, seeking regulatory
clearance in the European Union and the United States and raising
capital.
Through
December 31, 2008, we have generated minimal sales revenues, have incurred
significant expenses and have sustained losses. Consequently, our
operations are subject to all the risks inherent in the establishment of a new
business enterprise.
In May
2008, the Company received notice that the INVOcell product meets all the
essential requirements of the relevant European Directive(s), and received CE
Marking. The CE marking (also known as CE mark) is a mandatory
conformity mark on many products placed on the single market in the European
Economic Area (EEA). The CE marking (an acronym for the French
“Conformité Européenne”) certifies that a product has met EU health, safety and
environmental requirements, which ensure consumer safety.
With CE
Marking, the Company now has the ability and necessary regulatory authority to
distribute its product in the European Economic Area (Includes: The European
Union, Canada, Australia, New Zealand, and most parts of the Middle
East). The Company has sold 785 units of INVOcell to
date.
(B) Basis of Presentation
(Reverse Merger and Corporate Structure)
On
December 5, 2008, the Company completed a merger transaction with Emy’s Salsa
Aji Distribution Company, Inc. (“Emy’s”) an inactive publicly registered shell
corporation with no significant assets or operations. Emy’s was
incorporated on July 11, 2005, under the laws of the State of Nevada under the
name Certiorari Corp. In connection with the reverse merger, INVO
Bioscience became our wholly-owned subsidiary and the INVO Bioscience
Shareholders acquired control of Emy’s.
For
accounting purposes, the Company accounted for the transaction as a
recapitalization and the Company is the surviving entity. In
connection with the reverse merger, 14,937,500 shares were retained by Emy’s
shareholders.
Effective
with the Agreement, all previously outstanding shares of common owned by the
Company's shareholders were exchanged for an aggregate of 38,307,500 shares of
Emy’s common stock.
Effective
with the Agreement, Emys changed its name to INVO Bioscience Inc.
All
references to common stock, share and per share amounts have been retroactively
restated to reflect the exchange ratio of 357.0197 shares of INVO Bioscience
common stock for 1 shares of the acquirer's common stock outstanding immediately
prior to the merger as if the exchange had taken place as of the beginning of
the earliest period presented.
The
accompanying financial statements present the historical financial condition,
results of operations and cash flows of the Company prior to the merger with
Emys.
The
accompanying consolidated financial statements present on a consolidated basis
the accounts of the Company and its wholly owned subsidiaries. All
significant intercompany accounts and transactions have been eliminated in
consolidation.
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
as
of DECEMBER 31, 2008 and DECEMBER 31, 2007
(C) Use of Estimates
In
preparing financial statements in conformity with generally accepted accounting
principles, management is required to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent
assets and liabilities at the date of the financial statements and revenues and
expenses during the reported period. Actual results could differ from
those estimates.
(D) Cash and Cash Equivalents
The
Company considers all highly liquid temporary cash investments with an original
maturity of three months or less to be cash equivalents. As of
December 31, 2008 and 2007, the Company had $15,716 and $0 cash equivalents
respectively.
(E) Inventory
Inventories
consist of finished products and are stated at the lower of cost or market;
using the first-in, first-out (FIFO) method as a cost flow
convention.
(F) Property and Equipment
The
Company records property and equipment at cost. Depreciation and
amortization are provided using the straight-line method over the estimated
economic lives of the assets, which are from 3 to 7 years. The Company
capitalizes the expenditures for major renewals and improvements that extend the
useful lives of property and equipment. Expenditures for maintenance
and repairs are charged to expense as incurred. The Company reviews the
carrying value of long-lived assets for impairment at least annually or whenever
events or changes in circumstances indicate that the carrying amount of an asset
may not be recoverable. Recoverability of long-lived assets is
measured by a comparison of its carrying amount to the undiscounted cash flows
that the asset or asset group is expected to generate. If such assets
are considered impaired, the impairment to be recognized is measured by the
amount by which the carrying amount of the property, if any, exceeds its fair
market value.
(G) Stock Based Compensation
The
Company accounts for stock-based compensation under the provisions of SFAS
123R,
Share-Based
Payment
(“SFAS 123R”). This statement requires the Company to
measure the cost of employee services received in exchange for an award of
equity instruments based on the grant-date fair value of the
award. That cost is recognized over the period in which the employee
is required to provide service in exchange for the award, which is usually the
vesting period.
(
H) Loss Per Share
We use
SFAS No. 128, “Earnings Per Share” for calculating the basic and diluted
loss per share. We compute basic loss per share by dividing net loss
and net loss attributable to common shareholders by the weighted average number
of common shares outstanding. Common equivalent shares are excluded
from the computation of net loss per share if their effect is
anti-dilutive. There were 120,000 common share equivalents at
December 31, 2008 and none at December 31, 2007. For the year ended
December 31, 2008, these potential shares were excluded from the shares used to
calculate diluted earnings per share as their inclusion would reduce net loss
per share.
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
as
of DECEMBER 31, 2008 and DECEMBER 31, 2007
(I) Identifiable Intangible Assets
Intangible
assets are stated at cost net of accumulated amortization and
impairment. During the period December 31, 2008, the Company
purchased $31,000 of additional patents that establish and protect its
proprietary technology and product in several countries. The Company
intends to amortize these costs over the useful life of the
patents.
(
J) Fair Value of Financial
Instruments
SFAS No.
107, “Disclosures About Fair Value of Financial Instruments,” requires
disclosure of the fair value of certain financial instruments. The
carrying value of cash and cash equivalents, accounts payable and borrowings, as
reflected in the balance sheets, approximate fair value because of the
short-term maturity of these instruments.
Effective
January 1, 2008, the Company adopted Statement of Financial Accounting Standards
No. 157,
Fair Value
Measurements
(SFAS 157), which provides a framework for measuring fair
value under GAAP. SFAS 157 defines fair value as the exchange price
that would be received for an asset or paid to transfer a liability (an exit
price) in the principal or most advantageous market for the asset or liability
in an orderly transaction between market participants on the measurement
date. SFAS 157 requires that valuation techniques maximize the use of
observable inputs and minimize the use of unobservable inputs.
(K) Income Taxes
The
Company accounts for income taxes under the Statement of Financial Accounting
Standards No. 109, “
Accounting
for Income Taxes
” (“SFAS 109”). Under SFAS 109, deferred tax
assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax
bases. 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. Under
SFAS 109, the effect on deferred tax assets and liabilities of a change in tax
rates is recognized in income in the period that includes the enactment
date.
In July
2006, the FASB issued FIN 48, “Accounting for Uncertainty in Income Taxes-an
interpretation of FASB Statement No. 109” (“FIN 48”). FIN 48
clarifies the recognition threshold and measurement of a tax position taken on a
tax return. FIN 48 is effective for fiscal years beginning after
December 15, 2006. FIN 48 also requires expanded disclosure with
respect to the uncertainty in income taxes.
(L) Business Segments
The
Company operates in one segment and therefore segment information is not
presented.
(M) Concentration of Credit Risk
The
Company at times has cash in banks in excess of FDIC insurance
limits. The Company had no amounts in excess of FDIC insurance limits
as of December 31, 2008 and December 31, 2007.
(N) Revenue Recognition
The
Company will recognize revenue on arrangements in accordance with Securities and
Exchange Commission Staff Accounting Bulletin No. 101, “Revenue Recognition in
Financial Statements” and No. 104, “Revenue Recognition”. In all
cases, revenue is recognized only when the price is fixed and determinable,
persuasive evidence of an arrangement exists, the service is performed and
collectability of the resulting receivable is reasonably assured.
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
as
of DECEMBER 31, 2008 and DECEMBER 31, 2007
(O) Long- Lived Assets
Long-lived
assets and certain identifiable assets related to those assets are periodically
reviewed for impairment whenever circumstances and situations change such that
there is an indication that the carrying amounts may not be
recoverable. If the non-discounted future cash flows of the
enterprise are less than their carrying amount, their carrying amounts are
reduced to the fair value and an impairment loss recognized. There
was no impairment recorded from January 5, 2007 (inception) to December 31,
2008.
(P) Research and Development
The
Company accounts for research and development costs in accordance with the
Financial Accounting Standards Board's Statement of Financial Accounting
Standards No. 2 (“SFAS 2”), “Accounting for Research and Development
Costs.” Research and development costs include expenses incurred by
the Company for research, design and development of our proprietary technology
and are charged to operations as incurred. Accordingly, internal
research and development costs are expensed as incurred. Total
expenditures on research and product development for 2008 and 2007 were
approximately $52,000 and $33,000 respectively.
(Q) Recent
Accounting Pronouncements
In
December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No.
160, “
Noncontrolling Interests
in Consolidated Financial Statements – an amendment of ARB No.
51
.” This statement improves the relevance, comparability, and
transparency of the financial information that a reporting entity provides in
its consolidated financial statements by establishing accounting and reporting
standards that require; the ownership interests in subsidiaries held by parties
other than the parent and the amount of consolidated net income attributable to
the parent and to the noncontrolling interest be clearly identified and
presented on the face of the consolidated statement of income, changes in a
parent’s ownership interest while the parent retains its controlling financial
interest in its subsidiary be accounted for consistently, when a subsidiary is
deconsolidated, any retained noncontrolling equity investment in the former
subsidiary be initially measured at fair value, entities provide sufficient
disclosures that clearly identify and distinguish between the interests of the
parent and the interests of the noncontrolling owners. SFAS No. 160
affects those entities that have an outstanding noncontrolling interest in one
or more subsidiaries or that deconsolidate a subsidiary. SFAS No. 160
is effective for fiscal years, and interim periods within those fiscal years,
beginning on or after December 15, 2008. Early adoption is
prohibited. The adoption of this statement is not expected to have a
material effect on the Company's financial statements.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities, an amendment of FASB Statement No. 133”
(SFAS 161). This statement is intended to improve transparency in
financial reporting by requiring enhanced disclosures of an entity’s derivative
instruments and hedging activities and their effects on the entity’s financial
position, financial performance and cash flows. SFAS 161 applies to
all derivative instruments within the scope of SFAS 133, “Accounting for
Derivative Instruments and Hedging Activities” (SFAS 133) as well as related
hedged items, bifurcated derivatives, and nonderivative instruments that are
designated and qualify as hedging instruments. Entities with
instruments subject to SFAS 161 must provide more robust qualitative disclosures
and expanded quantitative disclosures. SFAS 161 is effective
prospectively for financial statements issued for fiscal years and interim
periods beginning after November 15, 2008, with early application
permitted. We are currently evaluating the disclosure implications of
this statement.
In May
2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted
Accounting Principles.” SFAS No. 162 identifies the sources of
accounting principles and provides entities with a framework for selecting the
principles used in preparation of financial statements that are presented in
conformity with GAAP. The current GAAP hierarchy has been criticized
because it is directed to the auditor rather than the entity, it is complex, and
it ranks FASB Statements of Financial Accounting Concepts, which are subject to
the same level of due process as FASB Statements of Financial Accounting
Standards, below industry practices that are widely recognized as generally
accepted but that are not subject to due process. The Board believes
the GAAP hierarchy should be directed to entities because it is the entity (not
its auditors) that is responsible for selecting accounting principles for
financial statements that are presented in conformity with GAAP. SFAS
162 is effective 60 days following the SEC’s approval of PCAOB Auditing Standard
No. 6, Evaluating Consistency of Financial Statements
(AS/6). The adoption of FASB 162 is not expected to have a material
impact on the Company’s financial position.
In May
2008, the FASB issued SFAS No. 163, “Accounting for Financial Guarantee
Insurance Contracts-an interpretation of FASB Statement No.
60.” Diversity exists in practice in accounting for financial
guarantee insurance contracts by insurance enterprises under FASB Statement No.
60, Accounting and Reporting by Insurance Enterprises. This results
in inconsistencies in the recognition and measurement of claim
liabilities. This Statement requires that an insurance enterprise
recognize a claim liability prior to an event of default (insured event) when
there is evidence that credit deterioration has occurred in an insured financial
obligation. This Statement requires expanded disclosures about
financial guarantee insurance contracts. SFAS 163 is effective for
financial statements issued for fiscal years beginning after December 15, 2008,
and interim periods for those fiscal years. The accounting and
disclosure requirements of the Statement will improve the quality of information
provided to users of financial statements. The adoption of FASB 163
is not expected to have a material impact on the Company’s financial
position.
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
as
of DECEMBER 31, 2008 and DECEMBER 31, 2007
In April
2008, the FASB issued FSP No. FAS 142-3, “Determination of the Useful Life of
Intangible Assets.” This FSP amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of
a recognized intangible asset under SFAS No. 142, “Goodwill and Other
Intangible Assets.” The Company is required to adopt FSP 142-3 on
January 1, 2009. The guidance in FSP 142-3 for determining the
useful life of a recognized intangible asset shall be applied prospectively to
intangible assets acquired after adoption, and the disclosure requirements shall
be applied prospectively to all intangible assets recognized as of, and
subsequent to, adoption. The Company is currently evaluating the
impact of FSP 142-3 on its consolidated financial position, results of
operations or cash flows.
In May
2008, the FASB issued FSP Accounting Principles Board (“APB”) 14-1 “Accounting
for Convertible Debt Instruments That May Be Settled in Cash upon Conversion
(Including Partial Cash Settlement)” (“FSP APB 14-1”). FSP
APB 14-1 requires the issuer of certain convertible debt instruments that
may be settled in cash (or other assets) on conversion to separately account for
the liability (debt) and equity (conversion option) components of the instrument
in a manner that reflects the issuer's non-convertible debt borrowing
rate. FSP APB 14-1 is effective for fiscal years beginning after
December 15, 2008 on a retroactive basis. The Company is
currently evaluating the potential impact, if any, of the adoption of FSP
APB 14-1 on its consolidated financial position, results of operations or
cash flows.
In June
2008, the FASB issued Emerging Issues Task Force No. 07-5 (EITF 07-5),
Determining Whether an Instrument
(or Embedded Feature) is Indexed to an Entity’s Own
Stock.
EITF 07-5 requires entities to evaluate whether an
equity-linked financial instrument (or embedded feature) is indexed to its own
stock by assessing the instrument’s contingent exercise provisions and
settlement provisions. Instruments not indexed to their own stock
fail to meet the scope exception of Statement of Financial Accounting Standards
No. 133,
Accounting for
Derivative Instruments and Hedging Activities
, paragraph 11(a), and
should be classified as a liability and marked-to-market. The
statement is effective for fiscal years beginning after December 15, 2008
and is to be applied to outstanding instruments upon adoption with the
cumulative effect of the change in accounting principle recognized as an
adjustment to the opening balance of retained earnings. The Company
is assessing the impact of this EITF for the year ended December 31,
2009.
Other
recent accounting pronouncements issued by the FASB (including its Emerging
Issues Task Force), the AICPA, and the SEC did not, or are not believed by
management to, have a material impact on the Company's present or future
consolidated financial statements.
As
reflected in the accompanying consolidated financial statements, the Company is
in the development stage and has just commenced operations in December 2008, has
a net loss of $1,873,000 a working capital deficiency of $690,000, a stockholder
deficiency of $677,000 and cash used in operations of $1,067,000 for the year
ended December 31, 2008. This raises substantial doubt about its
ability to continue as a going concern. The financial statements do
not include any adjustments that might be necessary if the Company is unable to
continue as a going concern. The ability of the Company to continue
as a going concern is dependent on the Company’s ability to raise additional
capital and implement its business plan.
As of
December 31, 2008 and 2007, the Company recorded the following inventory
balances:
|
|
December
31,
2008
|
|
December
31,
2007
|
Raw
Materials
|
|
$
|
-
|
|
$
|
-
|
Work
in Process
|
|
|
55,466
|
|
|
-
|
Finished
Goods
|
|
|
15,257
|
|
|
-
|
Total
Inventory
|
|
$
|
70,722
|
|
$
|
-
|
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
as
of DECEMBER 31, 2008 and 2007
NOTE
4
|
PROPERTY
AND EQUIPMENT
|
The
estimated useful lives and accumulated depreciation for furniture, equipment and
software are as follows:
|
Estimated
Useful Life
|
Molds
|
3 to 7 years
|
Computers
and Software
|
3 to 5 years
|
|
|
December
31,
2008
|
|
December
31,
2007
|
Manufacturing
Equipment- Molds
|
|
$
|
35,263
|
|
$
|
-
|
Less:
Accumulated Depreciation
|
|
|
980
|
|
|
|
Network/IT
Equipment
|
|
|
7,595
|
|
|
-
|
Less:
Accumulated Depreciation
|
|
|
633
|
|
|
|
|
|
$
|
41,245
|
|
$
|
-
|
During
the periods December 31, 2008 and 2007, the Company recorded $1,613 and $0 in
depreciation expense, respectively.
As of
December 31, 2008 and 2007, the Company recorded the following patent
costs:
|
|
December
31, 2008
|
|
|
December
31,
2007
|
|
Total
Patents
|
|
$
|
77,743
|
|
|
$
|
46,725
|
|
|
|
|
|
|
|
|
|
|
ACCUMULATED
AMORTIZATION
|
|
|
(9,351
|
)
|
|
|
(3,455
|
)
|
|
|
|
|
|
|
|
|
|
Patent
costs, net
|
|
$
|
68,392
|
|
|
$
|
43,270
|
|
During
the periods December 31, 2008 and 2007, the Company recorded $ 5,896 and $3,455,
respectively in amortization expenses.
NOTE
6
|
WORKING
LINE OF CREDIT
|
At
December 31, 2008, the Company had a $50,000 working capital line of credit with
Century Bank, interest payable monthly 0.24% above the bank’s prime lending rate
on 12/31/08 the rate was 3.79%, maturing May 31, 2010. At December
31, 2008 and 2007, the balance outstanding on the line of credit was $50,000 and
$49,221, respectively.
NOTE
PAYABLE AND OTHER RELATED PARTY TRANSACTIONS
On
September 18, 2008, the Company entered into a related party transaction with
Dr. Claude Ranoux. Dr. Ranoux is the President, Director and Chief
Scientific Officer of the Company. Dr. Ranoux had loaned funds to the
Company to sustain its operations since January 5, 2007
(inception). Ranoux’s total cumulative investment at December 31,
2008 is $96,462 (“the Principal Amount”) in INVO Bioscience. On December
1, 2008, Dr. Ranoux executed a letter agreement with the Company to amend the
Promissory Note to allow conversion into shares of Emy’s common stock following
the Closing. On March 26, 2009, the Company and Dr Ranoux agreed to
re-write the agreement to a non-convertible note payable bearing interest at 5%
per annum and extended the repayment date to March 31, 2010. The Company
and Dr. Ranoux can jointly decide to repay the loan earlier without prepayment
penalties.
For the
years ended December 31, 2008 and 2007, the Company charged an in-kind
contribution related to interest expense totaling $3,690 and $2,298,
respectively.
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
as
of DECEMBER 31, 2008 and 2007
NOTE 8
|
STOCKHOLDERS’
EQUITY
|
For the
period from January 5, 2007 (inception) through December 31, 2007, BioXcell
(INVO Bioscience) issued 70,000 shares of common stock for $20,000, at
$.2857/share. This was retroactively restated to 24,991,379 shares due to the
reverse merger on December 29, 2008.
On
December 29, 2008, the Company filed an amended and restated articles
of incorporation with the Secretary of State of Nevada. The
Company’s authorized capital stock was changed from 75,000,000 shares, all
of which were shares of common stock, par value $.0001 per share, to
authorized common stock of 200,000,000 shares, par value $.0001, and
100,000,000 newly created shares of undesignated preferred stock, par value
$.0001.
On
November 7, 2008, Emy’s Board of Directors approved a 5-1 forward stock split
(the “Forward Split”) of our common stock with a record date of November 10,
2008 for the Company’s issued and outstanding shares and not its authorized
shares. The Forward Split was payable on November 12,
2008. Emys had 12,387,500 shares outstanding prior to the Forward
Split and 61,937,500 shares outstanding thereafter.
The
Company had 61,937,500 shares issued and outstanding immediately prior to the
Share Exchange. Our charter does not authorize any shares of
preferred stock. Pursuant to the Share Exchange Agreement, certain
shareholders of Emy’s agreed to cancel 47,000,000 shares of Emy’s common stock
and Emys agreed to issue 38,307,500 newly-issued shares of common stock to INVO
Bioscience shareholders. As of December 5, 2008 and immediately after
Closing, an aggregate of 53,245,000 shares of common stock were outstanding,
including shares issued pursuant to the Closing.
After the
consummation of the transaction contemplated by the Share Exchange Agreement, on
the day of the Closing, we entered into the Securities Purchase Agreement with
the investors pursuant to which, the investors contributed $375,000 in exchange
for 375,000 shares of our common stock at a price of $1.00 per
share. The investors have piggyback registration rights that permit
them to register their common stock on any registration statement filed by the
Company.
During
the period from January 1, 2008 through November 30, 2008, the Company issued an
aggregate of 4,561,641 shares of common stock for cash totaling $706,938 for
share prices ranging from $0.15 to $1.50.
In March
2008, the Company issued an aggregate of 8,488,857 shares of common stock
(net of forfeitures) for services rendered totaling $11,259. In
November 2008, the Company issued an aggregate of 265,623 shares of common stock
for services rendered totaling $40,056.
Since
January 1, 2008, the Company has signed agreements for officers, executives and
service providers of the Company. As of December 31, 2008, a
total of 303,500 shares of common stock and options to purchase an additional
500,000 (including 461,000 of employee incentive stock options) of the Company’s
common stock were agreed to be issued. As of December 31, 2008, the
Company has not issued the committed shares and has recorded an accrued
liability of $313,500. As of December 31, 2008, the Company has not
obtained shareholder approval for the employee incentive stock option plan and
has not deemed the 500,000 options as granted until the plan is
approved.
During
the years ended December 31, 2008 and 2007, the Company recorded related party
contributed services and interest of $164,511 and $93,163,
respectively.
Non-Statutory Options
The
following table summarizes the changes in options outstanding and the related
prices for the shares of the Company’s common stock issued. These
options were granted in lieu of cash compensation for services
performed.
|
|
|
Options
Outstanding
|
|
Options
Exercisable
|
|
Exercise
Prices
|
|
|
Number
Outstanding
|
|
|
Weighted
Average
Remaining
Contractual
Life
(Years)
|
|
Number
Exercisable
|
|
Weighted
Average
Exercise
Price
|
|
$
|
1.00
|
|
|
|
140,000
|
|
|
|
2.9
|
|
|
$
|
-
|
|
|
$
|
-
|
|
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
as
of DECEMBER 31, 2008 and 2007
Transactions
involving warrants are summarized as follows:
|
|
Number
of
Shares
|
|
Weighted
Average
Price
Per
Share
|
Outstanding
at January 5, 2007
|
|
|
-
|
|
$
|
-
|
Granted
|
|
|
-
|
|
|
-
|
Exercised
|
|
|
-
|
|
|
-
|
Canceled
or expired
|
|
|
-
|
|
|
-
|
Outstanding
at December 31, 2007
|
|
|
-
|
|
$
|
-
|
Granted
|
|
|
140,000
|
|
|
1.00
|
Exercised
|
|
|
-
|
|
|
-
|
Canceled
or expired
|
|
|
-
|
|
|
-
|
Outstanding
at December 31, 2008
|
|
|
140,000
|
|
$
|
1.00
|
Aggregate
intrinsic value of options outstanding and exercisable at December 31, 2008 was
$630,000. Aggregate intrinsic value represents the difference between
the Company's closing stock price on the last trading day of the fiscal period,
which was $5.50 as of December 31, 2008, and the exercise price multiplied by
the number of options outstanding. As of December 31, 2008, total
unrecognized stock-based compensation expense related to stock options was
$210,000. During the year ended December 31, 2008, the Company did
not charge to operations the related expense to recognized stock-based
compensation for the above stock options.
The
Company has adopted Financial Accounting Standard number 109, which requires the
recognition of deferred tax liabilities and assets for the expected future tax
consequences of events that have been included in the financial statement or tax
returns. Under this method, deferred tax liabilities and assets are
determined based on the difference between financial statements and tax basis of
assets and liabilities using enacted tax rates in effect for the year in which
the differences are expected to reverse. Temporary differences
between taxable income reported for financial reporting purposes and income tax
purposes are insignificant.
For
income tax reporting purposes, the Company's aggregate unused net operating
losses approximate $1,800,000, expire at various times through 2028, subject to
limitations of Section 382 of the Internal Revenue Code, as
amended. The deferred tax asset related to the carry forward is
approximately $540,000. The Company has provided a valuation reserve
against the full amount of the net operating loss benefit, since in the opinion
of management based upon the earning history of the Company, it is more likely
than not that the benefits will not be realized.
On
January 1, 2007, the Company entered into an operating lease (the “lease”) with
Cummings Properties, LLC, to lease 3,294 square feet of general office
space. The lease commenced on January 1, 2007 and was automatically
extended in October 2008 until December 31, 2010. The Company agreed
to pay a security deposit of $3,000 on January 1, 2007, which was repaid to the
Company in equal $500 installments over the first six months of the
lease. The Company received no rent incentives or improvement
allowances under this agreement. The lease requires the Company to
pay minimum lease payments of $2,000 per month for the duration of the
lease. The lease is subject to a cost of living increase equal to the
Boston, MA Consumer Price Index at the beginning of each calendar
year. As of January 1, 2009, the Company’s lease payments under this
agreement increased 3.53% to $2,070.60.
Fiscal
Year
|
|
Minimum
Future Lease Payments
|
|
2009
|
|
$
|
24,847
|
|
2010
|
|
$
|
24,847
|
|
INVO
BIOSCIENCE, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
as
of DECEMBER 31, 2008 and 2007
On
October 22, 2007, the Company entered into a fee agreement with Business Growth
Resources, LLC (“BGR”), 28 Aspenwood St., Suite 215, Simsbury, CT to assist the
Company with raising operating capital. The Company agreed to pay
Business Growth Resources a retainer of $7,500 payable as follows: $2,500 upon
execution of the agreement, and $2,500 every thirty days
thereafter. The Company also agreed to pay Business Growth Resources,
LLC 5% of any investment proceeds that were introduced to the Company by
BGR. Because of BGR’s inability to introduce viable investment
opportunities to the Company, the two parties separated the agreement on August
9, 2008. The Company paid $5,000 for BGR’s efforts.
On
December 5, 2008 in conjunction with the closing of the Securities Exchange
Agreement the Company signed a term sheet with Lionshare Ventures LLC
(“LSV”). The terms of the agreement were such that LSV agreed to
invest the balance of its original commitment to the Company dated May 19, 2008
in the amount of $450,000. 2,000,000 shares of common stock were
escrowed until the money was funded to the Company. As of today, LSV has
delivered $200,000 and the Company released 1,000,000 of common shares from
escrow.
|
C)
|
Anti-Dilution
and Piggyback Registration Rights
|
On
December 5, 2008, we entered into the Securities Purchase Agreement with the
certain investors who have piggyback registration rights that permit them to
register their common stock on any registration statement filed by the
Company. In addition, pursuant to certain anti-dilution rights granted
under the Securities Purchase Agreement to the investors, the Company may be
obligated to issue additional shares of its common stock to the investors in the
event it issues common stock to future investors at a per share purchase price
less than $1.00. The number of additional shares to be issued in such
event is equal to that number of shares that the investors would have acquired
at such price had that price been offered at the time of their original
investment, minus the number of shares acquired in their original
investment. Further, pursuant to the letter agreement, LSV and its
managing member, Christopher Esposito, have agreed to forfeit to us, one share
of our common stock for every two shares we would be required to issue up to the
maximum of 562,5000 shares, which number of shares are being held in escrow by
us until December 5, 2010.
Since
January 1, 2008, the Company has signed nine employee agreements for officers,
executives and employees of the Company. Three of these agreements
were with the founders of the Company.
The
remaining six of the agreements were executed with executives and staff of the
Company. These employees were issued common shares and options to
purchase common shares of the Company. Under the terms of these
employee agreements, these shares only vest upon the completion of the Exchange
Agreement and the implementation of the Company’s Employee Stock Plan. The
Exchange Agreement closed on December 5, 2008, the Company has yet to implement
an Employee Stock Plan, it is planning to do so in the second quarter of
2009. As of today, a total of 303,500 shares of common stock and
options to purchase an additional 700,000 shares of the Company’s common stock
have been promised but not issued.
8,790,000
Shares of
Common
Stock
________________________
PROSPECTUS
_______________________
December
21, 2009
PART
II - INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 13.
OTHER EXPENSES OF ISSUANCE AND
DISTRIBUTION
The
following table sets forth an itemization of various expenses, all of which we
will pay, in connection with the sale and distribution of the securities being
registered. All of the amounts shown are estimates, except the Securities and
Exchange Commission registration fee.
Securities
and Exchange Commission Registration Fee
|
|
$
|
200.57
|
|
Accounting
Fees and Expenses
|
|
|
10,000.00
|
|
Legal
Fees and Expenses
|
|
|
30,000.00
|
|
State
securities fees
|
|
|
2,000.00
|
|
Transfer
agent fees
|
|
|
10,000.00
|
|
Miscellaneous
|
|
|
5,000.00
|
|
Total
|
|
$
|
57,200.57
|
|
ITEM 14.
INDEMNIFICATION OF DIRECTORS AND
OFFICERS
Our
Articles of Incorporation and By-laws provide for indemnification of our
officers and directors to the fullest extent permissible under Nevada law.
Additionally, we have entered into indemnification agreements with each of our
officers and Directors, and therefore purchasers of these securities may have a
more limited right of action than they would have except for this limitation in
the Articles of Incorporation and By-laws. These agreements provide, in general,
that we shall indemnify and hold harmless such directors and officers to the
fullest extent permitted by law against any judgments, fines, amounts paid in
settlement, and expenses, including attorneys' fees and disbursements, incurred
in connection with, or in any way arising out of, any claim, action or
proceeding against, or affecting, such directors and officers resulting from,
relating to or in any way arising out of, the service of such persons as our
directors and officers.
ITEM
15. RECENT SALES OF UNREGISTERED SECURITIES
We have
sold certain shares of common stock for cash and have issued shares of common
stock in exchange for services. For the following issuances of our
securities, we claimed the exemption from registration set forth in Section 4(2)
of the Securities Act and the rules thereunder, as private transactions not
involving a public distribution. The facts we relied upon to claim
the exemption include: (i) the purchasers represented that they purchased shares
from the Company for investment and not with a view to distribution to the
public; (ii) each certificate issued for unregistered securities contains a
legend stating that the securities have not been registered under the Securities
Act and setting forth the restrictions on the transferability and the sale of
the securities; (iii) the purchasers as well as most of those who received
shares for services represented that they were accredited investors and
sophisticated and all were familiar with our business activities; and (iv) the
purchasers and service providers were given full and complete access to any
corporate information requested by them.
On
December 5, 2008, Bio X Cell, Inc., a Commonwealth of Massachusetts corporation
doing business as INVO Bioscience (hereinafter “INVO Bioscience”), and each of
the 8 shareholders of INVO Bioscience (the “INVO Bioscience
Shareholders”). entered into a share exchange agreement (the “Share
Exchange Agreement”) and consummated a share exchange (the “Share Exchange”)
with the Company, which was then known as Emy’s Salsa Aji Distribution Company,
Inc. (“Emy’s”). Upon the closing of the Share Exchange on December 5, 2008 (the
“Closing”), the INVO Bioscience Shareholders transferred all of their shares of
common stock in INVO Bioscience to Emy’s. In exchange, we issued to
the INVO Bioscience Shareholders an aggregate of 38,307,500 shares of Emy’s
common stock (the “common stock”), $0.0001 par value per share, representing
71.9% of the shares issued and outstanding immediately after the
Closing. As a result of the Share Exchange, INVO Bioscience became a
wholly-owned subsidiary of Emy’s.
Immediately
following the Closing of the Share Exchange, we entered into a securities
purchase agreement (the “Securities Purchase Agreement”) with GRQ Consulting,
LLC and Whalehaven Capital Fund Limited. Pursuant to the Securities
Purchase Agreement, the investors invested $375,000 in exchange for 375,000
shares of our common stock at a price of $1.00 per
share.
In March
2009, we issued an aggregate of 83,333 shares of common stock Wakabayashi Fund,
LLC for investor relations services in the Asian markets
totaling
$37,500.
In May
2009, we issued an aggregate of 125,000 shares of common stock for U.S. based
investor relations and fund raising services rendered to Investor Awareness, Inc
and Red Chip Securities for a combined value totaling $15,500.
During
the period July 15, 2009 to September 15, 2009, we issued convertible notes
payable (“Bridge Notes”) to accredited investors in the aggregate amount of
$545,000. The Bridge Notes carry interest rates ranging from 10-12%
and are due in full in one year from the date of issuance. The Bridge
Notes and accrued interest are convertible into our common stock at a conversion
price of $0.10 per share, subject to adjustments. In addition to the Bridge
Notes, we issued warrants to purchase 5,750,000 shares of the Company’s common
stock at a price of $0.20 per share.
In
September 2009, we issued an aggregate of 1,125,000 shares of common stock to
GRQ Consulting and Whalehaven (described above) in connection with the execution
of a $100,000 convertible note as part of a bridge offering. The
Bridge Notes transaction triggered the anti-dilution clause of the Securities
Purchase Agreement executed on December 5, 2008 with the
investors.
In
September 2009, the Company issued an aggregate of 857,000 shares of common
stock for a number of different services which rendered a total of $299,950. The
services included investor relations from College Stock LLC which received the
majority of these shares (500,000), 140,000 shares were issued to two former
employees per their employment agreement, the balance of the shares were
distributed to 7 other individuals for engineering and manufacturing support
(25,000 shares), sales consulting (102,000 shares), legal guidance (50,000
shares) and technical assistance (40,000 shares),
In
October, 2009, we entered into the REF with AGS Capital Group, LLC
pursuant to
which AGS committed to purchase, from time to time over a period of two years,
shares of our common stock for cash consideration up to $10,000,000, subject to
certain conditions and limitations. In connection with the REF, we
also entered into a registration rights agreement with AGS, dated October 28,
2009. The terms of the REF are described elsewhere in this
Registration Statement.
In
November 2009, we issued an aggregate of 612,000 shares of common stock of which
600,000 were issued to Gilford Securities for the REF and 12,000 for accounting
& reporting services rendered for a value totaling $312,120.
In
November 2009, we issued an aggregate of 2,100,000 shares of common stock for
the conversion of $210,000 of the Bridge Notes described above.
In
November 2009, we issued an aggregate of 42,930 shares of common stock for the
interest related to conversion of $210,000 of Convertible Notes Payable into
common stock at a price of $0.10 per common share.
ITEM 16.
EXHIBITS AND FINANCIAL STATEMENT
SCHEDULES
(a)
(1) Our un-audited and audited financial statements are included in
the prospectus.
(a)
(2) The following exhibits are being filed herewith.
EXHIBIT NUMBER
|
|
DESCRIPTION
|
2. 1
|
|
Share
Exchange Agreement, dated December 5, 2008, by and among Registrant, INVO
Bioscience and INVO Bioscience Shareholders(3)
|
2. 2
|
|
Securities
Purchase Agreement dated December 5, 2008, between Registrant and the
investors named therein(3)
|
3. 1
|
|
Articles
of Incorporation of Registrant(1)
|
3. 2
|
|
Certificate
of Amendment to Articles of Incorporation of
Registrant(1)
|
3. 3
|
|
By-Laws
of Registrant(2)
|
3. 4
|
|
Certificate
of Amendment to Articles of Incorporation of Registrant dated December 22,
2008(4)
|
4. 1
|
|
Form
of Senior Secured Convertible Promissory Note(9)
|
4. 2
|
|
Form
of Purchase Agreement(9)
|
4. 3
|
|
Form
of Warrant Purchase Agreement(9)
|
4. 4
|
|
Reserve
Equity Financing Agreement, dated October 28, 2009, by and between AGS
Capital Group, LLC and Invo Bioscience, Inc(11)
|
4. 5
|
|
Registration
Rights Agreement, dated October 28, 2009, by and between AGS Capital
Group, LLC and Invo Bioscience, Inc.(11)
|
5. 1
|
|
|
10. 1
|
|
Distribution
Agreement between the company and Orbital Group,
LLC.(2)
|
10. 2
|
|
Employment
Agreement for the Registrant’s President(7)
|
10. 3
|
|
Employment
Agreement for the Registrant’s Chief Executive
Officer(7)
|
10. 4
|
|
Employment
Agreement for the Registrant’s Chief Financial
Officer(7)
|
10. 5
|
|
Customer
Distribution Agreement – Canada – MediTech First(7)
|
10. 6
|
|
Customer
Distribution Agreement – Turkey – Gonagen(7)
|
10. 7
|
|
Customer
Distribution Agreement – Peru – CRHL(7)
|
10. 8
|
|
Claude
Ranoux Loan Agreement(8)
|
10. 9
|
|
Claude
Ranoux Loan Amendment(8)
|
10.10
|
|
Wakabayashi
Fund, LLC Agreement(8)
|
10.11
|
|
Red
Chip Securities, Inc. Agreement(8)
|
10.12
|
|
Kathleen
Karloff Loan Agreement(8)
|
10.13
|
|
Hallmark
Investments, Inc. Agreement(9)
|
10.14
|
|
Kathleen
Karloff Revised Loan Agreement(10)
|
10.15
|
|
Lionshare
Ventures Revised Agreement(10)
|
10.16
|
|
Placement
Agent Agreement, dated September 22, 2009, by and between Gilford
Securities, Inc. and Invo Bioscience, Inc.(11)
|
10.17
|
|
College
Stock, Inc. Agreement(12)
|
23. 1
|
|
|
23. 2
|
|
|
23. 3
|
|
Consent
of Shulman, Rogers, Gandal, Pordy & Ecker P.A (included in Exhibit
5.1)
|
|
|
|
(1)
Incorporated by reference to the Registrant’s Registration Statement on Form
SB-2/A filed with the Securities
and
Exchange Commission on January 25, 2008
(2)
Incorporated by reference to the Registrant’s Registration Statement on Form
SB-2 filed with the Securities and
Exchange
Commission on November 13, 2007
(3)
Incorporated by reference to the Registrant’s Current Report on Form 8-K filed
with the Securities and
Exchange
Commission on December 12, 2008
(4)
Incorporated by reference to the Registrant’s Current Report on Form 8-K filed
with the Securities and
Exchange
Commission on January 5, 2009
(5)
Incorporated by reference to the Registrant’s Current Report on Form 8-K/A filed
with the Securities and
Exchange
Commission on February 17, 2009
(6)
Incorporated by reference to the Registrant’s Current Report on Form 8-K/A filed
with the Securities and
Exchange
Commission on March 19, 2009
(7)
Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the
fiscal year ended December
31,
2008 and filed with the Securities and Exchange Commission on April 15,
2009
(8)
Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for
the three months ended March
31,
2009 filed with the Securities and Exchange Commission on May 15,
2009
(9)
Incorporated by reference to the Registrant’s Current Report on Form 8-K filed
with the Securities and
Exchange
Commission on July 17, 2009
(10)
Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for
the three months ended June
30,
2009 filed with the Securities and Exchange Commission on August 15,
2009
(11) Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed with the
Securities and
Exchange
Commission on November 3, 2009
(12)
Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for
the three months ended
September
30, 2009 filed with the Securities and Exchange Commission on November 16,
2009
ITEM 17.
UNDERTAKINGS
(a) The
undersigned registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) to
include any prospectus required by Section 10(a)(3) of the Securities Act
of 1933;
(ii) to
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in this registration statement. Notwithstanding the
foregoing, any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum
offering range may be reflected in the form of prospectus filed with the
Commission pursuant to Rule 424(b) if, in the aggregate the changes in volume
and price represent no more than 20 percent change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in the
effective registration statement; and
(iii) to
include any material information with respect to the plan of distribution not
previously disclosed in this registration statement or any material change to
such information in this registration statement.
(2) That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering
thereof.
(3) To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
(h)
Insofar as indemnification for liabilities arising under the Securities Act of
1933 may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions, or otherwise, the registrant
has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
(i) The
undersigned registrant hereby further undertakes that:
(1) For
purposes of determining any liability under the Securities Act of 1933, the
information omitted from the form of prospectus filed as part of this
registration statement in reliance under Rule 430A and contained in a form of
prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4), or 497(h)
under the Securities Act of 1933 shall be deemed to be part of this registration
statement as of the time it was declared effective.
(2) For
the purpose of determining any liability under the Securities Act of 1933, each
post-effective amendment that contains a form of prospectus shall be deemed to
be a new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.
SIGNATURES
In
accordance with the requirements of the Securities Act of 1933, the Registrant
has duly caused this Registration Statement to be signed on its behalf by the
undersigned, in the City Beverly in the Commonwealth of Massachusetts, on December 28, 2009 .
INVO
BIOSCIENCE, INC.
By:
/s/ Kathleen
T. Karloff
Kathleen T. Karloff
Chief Executive Officer
We the
undersigned officers and directors of INVO Bioscience, hereby severally
constitute and appoint Kathleen T. Karloff and Robert Bowdring, our true and
lawful attorney-in-fact and agent, with full power of substitution and
re-substitution in her, for her, and in her name, place and stead, and in any
and all capacities, to sign any and all amendments (including post-effective
amendments) to this Registration Statement (or any other Registration Statement
for the same offering that is to be effective upon filing pursuant to Rule
462(b) under the Securities Act of
1933), and to file the same, with all
exhibits thereto and other documents in connection therewith, with
the Securities and Exchange Commission, granting unto said attorney-in- fact and
agents full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as full to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorney-in-fact and agent or his substitute may
lawfully do or cause to be done by virtue hereof.
In
accordance with the requirements of the Securities Act of 1933, this
Registration Statement was signed by the following persons in the capacities and
on the dates indicated
|
INVO
BIOSCIENCE, INC.
|
|
Date:
December 28, 2009
|
|
By:
/s/ Kathleen T.
Karloff
|
Name:
Kathleen T. Karloff
Title:
Chief Executive Officer and Director
|
|
|
By:
/s/ Claude
Ranoux
|
Name:
Claude Ranoux, MD
|
Title:
President and Director
|
By:
/s/ Robert J.
Bowdring
|
Name:
Robert J. Bowdring
Title:
Chief Financial and Accounting
Officer
|