UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON, D.C.
20549
_______________________
FORM
10-KSB/A
ANNUAL REPORT UNDER SECTION 13 OR 15
(d)
OF THE SECURITIES EXCHANGE ACT OF
1934
For
the fiscal year ended: June 30, 2007
Commission File Number:
0-21271
_______________________
SANGUI
BIOTECH INTERNATIONAL, INC.
(Name of
Small Business Issuer in Its Charter)
Colorado
|
84-1330732
|
(State or Other Jurisdiction of Incorporation or
Organization)
|
(I.R.S.
EmployerIdentification No.)
|
Alfred Herrhausen
Street 44, Witten
Germany
|
58455
|
(Address
of principal executive offices)
|
(Zip
Code)
|
49 (2302)
915-200
(Issuer’s
Telephone Number, including Area Code)
Securities
registered under Section 12(b) of the Exchange Act:
None
Securities
registered under Section 12(g) of the Exchange Act:
Common Stock, no par
value
Check
whether the issuer is not required to file reports pursuant to Section 13 or
15(d) of the Exchange Act.
o
Check
whether the issuer: (1) filed all reports required to be filed by Section 13 or
15 (d) of the Securities Exchange Act during the past 12 months (or for such
shorter period that a Registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days.
Yes
x
No
o
Check if
there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-B is contained in this form, and no disclosure will be contained,
to the best of Registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-KSB or any
amendment to this Form 10-KSB.
o
Indicate by check mark whether the
Registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act). Yes
o
No
x
The
Issuer's revenues for the most recent fiscal year ended June 30, 2007, were
approximately
$372,015.
The
aggregate market value of the voting and non-voting common equity held by
non-affiliates of the Registrant on October 14, 2008 based upon the average
of the bid and ask price of the common stock on the pinksheets.com for such
date, was approximately $4,775,000.
The
number of shares of the Registrant's common stock issued and outstanding on
October 14, 2008 was 50,000,000.
Transitional
Small Business Disclosure Format. Yes
o
No
x
Table of Contents
i
CAUTIONARY
STATEMENT
Some of
the statements contained in this Form 10-KSB for Sangui Biotech International,
Inc. (the “Company” or “SGBI”) discuss future expectations, contain projections
of results of operation or financial condition or state other “forward-looking”
information. These statements are subject to known and unknown risks,
uncertainties, and other factors that could cause the actual results to differ
materially from those contemplated by the statements. The
forward-looking information is based on various factors and is derived using
numerous assumptions. Important factors that may cause actual results
to differ from projections include, for example:
·
the
success or failure of management's efforts to implement their business
strategy;
·
the
ability of the Company to raise sufficient capital to meet operating
requirements;
·
the
uncertainty of consumer demand for our product;
·
the
ability of the Company to protect its intellectual property rights;
·
the
ability of the Company to compete with major established companies;
·
the
effect of changing economic conditions;
·
the
ability of the Company to attract and retain quality employees; and
·
other
risks which may be described in future filings with the SEC.
Words
such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,”
“estimates,” and variations of such words and similar expressions are intended
to identify such forward-looking statements. These statements are not
guarantees of future performance and are subject to certain risks, uncertainties
and assumptions that are difficult to predict. Therefore, actual
results and outcomes may differ materially from what is expressed or forecasted
in any such forward-looking statements. Such risks and uncertainties
include those set forth herein under “Risk Factors” as well as those noted in
the documents incorporated herein by reference. Unless required by
law, the Company undertakes no obligation to update publicly any forward-looking
statements, whether as a result of new information, future events or
otherwise.
ii
PART
1
ITEM 1.
DESCRIPTION
OF BUSINESS
HISTORY
Sangui
BioTech, Inc. was incorporated in Delaware on August 2, 1996, and began
operations in October 1996. Shortly after the formation of Sangui
BioTech, Inc., the shareholders of SanguiBioTech AG and GlukoMediTech AG agreed
to a share swap in which all of the outstanding shares held by the shareholders
would be exchanged for shares of Sangui BioTech, Inc., thereby making
SanguiBioTech AG and GlukoMediTech AG wholly owned subsidiaries of Sangui
BioTech, Inc. In August 1997, a publicly held company, Citadel
Investment System, Inc., a Colorado corporation (Citadel), acquired one hundred
percent (100%) of the outstanding common shares of Sangui BioTech, Inc., and as
a result, Sangui BioTech, Inc. became a wholly owned subsidiary of
Citadel. Thereafter, Citadel changed its name to Sangui BioTech
International, Inc. (the Company or SGBI).
On March
30, 2000, SGBI acquired all the outstanding common stock of Felnam Investments,
Inc., a Nevada corporation (Felnam). The transaction was funded
through the issuance of 100,000 shares of SGBI's stock valued at $0 per share
due to SGBI treating the transaction as a recapitalization of
SGBI. In conjunction with the transaction, SGBI incurred
approximately $180,000 of transaction costs that were charged to
operations.
Until the
end of fiscal year 2002, SGBI's business operations were conducted through its
four wholly owned subsidiaries: Sangui BioTech, Inc., SanguiBioTech AG,
GlukoMediTech AG, and Sangui Biotech Singapore Pte Ltd.
Sangui BioTech,
Inc.
Sangui,
BioTech, Inc. (SBT) was principally engaged in the development and manufacturing
of immunodiagnostic kits, which were sold by SBT in niche markets in the United
States and Europe. During the first quarter of the 2003 fiscal year,
SBT sold its assets, and commenced a wind-down of its U.S. business
operations. SBT was merged with and into SGBI effective December 31,
2002.
Sangui Biotech Singapore Pte
Ltd
.
Sangui
Biotech Singapore Pte Ltd. (Sangui Singapore) was incorporated as a wholly owned
subsidiary of SGBI in Singapore on May 15, 1999. Sangui Singapore was
the Asian regional office for SGBI and was engaged in animal experiments in
conjunction with the German subsidiaries. Effective as of January 31,
2003, Sangui Singapore was wound down and closed. On February 25,
2004, the Registry of Companies and Businesses of the Republic of Singapore
informed the company, that it would announce the projected strike-off from its
register in its official Gazette on March 31, 2004 and that three months
following the name of Sangui Singapore would be struck off the register without
further notice. The company assumes, therefore, that the strike-off
was executed on or about June 30, 2004.
GlukoMediTech
AG
GlukoMediTech
AG (Gluko AG) was established and organized under the laws of Germany in Mainz,
Germany on July 15, 1996. Gluko AG was developing long-term
implantable glucose sensors, by-products thereof, and diverse other
sensors. Since additional financing for the next planned step of
product development could not be secured, Gluko AG was merged with Sangui AG
effective June 30, 2002. While further development work in this area
was halted, Sangui GmbH (see below) is working to secure the key patents
relating to the existing Glucose Sensors and will continue to seek out potential
strategic financial or industry partners.
SanguiBioTech
AG
SanguiBioTech
AG (Sangui GmbH) was established and organized under the laws of Germany in
Mainz, Germany on November 25, 1995. Effective November 4, 2003,
SanguiBioTech AG was converted into SanguiBioTech GmbH, a limited liability
company under German law. Sangui GmbH develops hemoglobin-based
artificial oxygen carriers for use as blood additives, blood volume substitutes
and variant products thereof. Sangui GmbH has also developed an
anti-aging cosmetic and a number of related products aimed at improving oxygen
supply to the skin. Enhanced oxygen supply is the key to improved
wound healing, therefore the company has extended its product portfolio to
contain wound pads and other wound management products with these goals in
mind. The facilities of Sangui GmbH are located on the premises of
the Forschungs- und Entwicklungszentrum of the University of Witten/Herdecke,
Witten, Germany.
To date,
neither SGBI nor any of its subsidiaries has had profitable
operations. The Company has never been profitable, and through June
30, 2007, SGBI's accumulated deficit has exceeded $22.4 million. The
Company expects to continue to incur substantial losses over the next several
years as it pursues its research and development efforts, testing activities and
other growth operations. SGBI's most promising potential products are
still in early development stages. As such the Company will need to
obtain substantial additional capital to fulfill its business plan.
The Company has adopted a program aimed at cost reductions and at refocusing
SGBI’s funds to accelerate time to market for its most promising and mature
products. Effective as of August 31, 2004, the company reduced any
extraneous activities for cost saving purposes. The Company’s current
key focus is on selling its cosmetics and wound management products to
distribution partners, identifying additional industrial and distribution
partners for its patents and products, and on obtaining the additional financial
resources necessary to finalize the certification processes of its development
products. No assurance can be given that SGBI’s program will be
successful.
BUSINESS OF THE
COMPANY
The
Company's mission is the development of novel and proprietary pharmaceutical,
medical and cosmetic products. The Company develops its products
through its wholly owned German subsidiary Sangui GmbH. The Company
is seeking to market and sell some, or all, of their products through
partnerships with industry partners.
The focus
of Sangui GmbH has been the development of oxygen carriers capable of providing
oxygen transport in humans in the event of acute and/or chronic lack of oxygen
due to arterial occlusion, anaemia or blood loss whether due to surgery, trauma,
or other causes. Sangui GmbH has thus far focused its development and
commercialization efforts of such artificial oxygen carriers by reproducing and
synthesizing polymers out of native hemoglobin of defined molecular
sizes. Sangui GmbH, has in addition developed external applications
of oxygen transporters in the medical and cosmetic fields in the form of gels
and emulsions for the regeneration of the skin.
Sangui
GmbH holds the exclusive distribution rights for Chitoskin wound pads for the
European Union and various other countries. Sangui GmbH has filed a
patent cooperation treatment applications (PCT) for the production and use of
improved Chitoskin wound pads using gelatine instead of collagen as the carrier
substance. In addition, Sangui GmbH is a co-filer for a PCT for the
production and use of glycosaminoglycans
based on Chitosan and its
derivatives.
ARTIFICIAL OXYGEN
CARRIERS
Sangui
GmbH develops several products based on polymers of purified natural porcine
hemoglobin with oxygen carrying abilities that are similar to native
hemoglobin. These are (1) oxygen carrying blood additives; and, (2)
oxygen carrying blood volume substitutes.
In
December 1997, Sangui GmbH decided that porcine hemoglobin should be used as the
basic material for its artificial oxygen carriers. In March 1999,
Sangui GmbH decided which hemoglobin hyperpolymer would go into preclinical
investigation, that glutaraldehyde would be utilized as a cross linker, and
further that the polymer hemoglobin be chemically masked to prevent protein
interaction in blood plasma. The fine adjustment of the molecular
formula of the artificial oxygen carriers - optimized for laboratory scale
production - was finalized in the summer of 2000.
The
experiments completed in Sangui GmbH’s laboratories demonstrated that it is
possible to polymerize hemoglobins isolated from porcine blood resulting in huge
soluble molecules, so-called hyperpolymers. In August 2000, Sangui
GmbH finalized its work on the pharmaceutical formulation of the oxygen carrier
for laboratory scale. In February 2001 a pilot production in a
laboratory scale was carried out in SGBI's clean room. The resulting
product was applied in single volunteers in pilot self-experiments.
The blood
additives and blood substitute projects were halted in 2003 due to the lack of
financing for the pre-clinical test phase. In October 2006, a
contract was entered into between Sangui GmbH and ERC Nano Med S.A. de C.V. of
Monterrey Mexico (ERC), which provides that ERC will establish a production
facility in Mexico to produce sufficient quantities of the blood
additive. In cooperation with the Mexican National Health
Organizations, ERC will initiate all necessary steps to begin the pre-clinical
test phase for the products as soon as possible. It is anticipated
that this will lead to the FDA authorization process in due course.
According
to regulatory requirements, all drugs must complete preclinical and clinical
trials before approval (e.g.
Government Regulation; No Assurance of Product
Approval
, see Certain Business Risks below) and market
launch. The Company’s management believes that the European and FDA
approval process will take at a minimum several years to complete.
NANO FORMULATIONS FOR THE
REGENERATION OF THE SKIN
Healthy
skin is supplied with oxygen both from the inside, by way of the blood, as
well as through diffusion from the outside. A lack of oxygen will
cause degenerative alterations, ranging from premature aging, to surface damage,
and even as extensive as causing open wounds. The cause for the lack
of oxygen may be a part of the normal aging process, but it may also be caused
by burns, radiation, trauma, or a medical condition. Impairment of
the blood flow, for example caused by diabetes mellitus or by chronic venous
insufficiency, can also lead to insufficient oxygen supply and the resulting
skin damage.
The
nano-emulsion-based preparations now being sold by Sangui GmbH have been
designed to support the regeneration of the skin by improving its oxygen
supply. The products Sangui GmbH are currently focussing on are:
(1) an anti-aging formulation and treatment; and, (2) an
anti-cellulite formulation for the cosmetics market. The products
were thoroughly tested by an independent research institute and received top
marks for skin moisturization, and enhanced skin elasticity,
respectively.
Sangui’s
cosmetic business model is reliant upon cooperation with its manufacturing and
distribution partners. Sangui has its various formulations produced
by a contract manufacturer and sells quantities of the products either in bulk
or in customized private label packaging as requested. In addition,
Sangui started to sell its cosmetic products under its own brand “Pure
MO2isture” via an internet shop in September of 2006.
Sales of
the anti-cellulite products began in August of 2005 via two German TV shop
programs. Additionally, distribution partners in Argentina and Mexico
have purchased quantities in November of 2005, and July of 2006,
respectively.
2
CHITOSKIN WOUND
PADS
In March
2005, SanguiBioTech GmbH was awarded the CE mark for this
product. The CE mark authorizes the company to distribute and sell
this medical product in the member countries of the European
Union. At the same time, Sangui GmbH successfully passed the ISO
9001:2000 (General Quality Management System) and ISO 13485:2003 (Quality
Management System Medical Products) audits, and obtained the respective
certifications. The “Chitoskin” trademark was already granted to the
company for the European countries effective November 1, 2004.
Karl Beese GmbH, a leading German
vendor and distributor of hospital supplies, began marketing and distributing
the wound pad product in August 2005, and has placed several subsequent orders
with the company. In addition, Karl Beese has delivered large
quantities of the wound pad product to a Czech distribution partner through
summer 2006.
PUBLIC
GRANTS
Sangui
GmbH was granted a subsidy amounting to $1,535,300 for the period from April 8,
1998 to March 31, 2001 for research and development in association with the
project known as “Development of a procedure for the production of synthetic
oxygen carriers on the basis of hyperpolymer hemoglobins as a blood additive and
a so-called blood substitute.” In March 2001, an application to have
the subsidy period extended to June 30, 2002 was approved. In March
2002, SGBI submitted a second application to the project authority, Jülich
(PtJ), to have the subsidy period extended again; this was approved for the
period up to December 31, 2002 in the notification of alteration dated July 2,
2002. Funds in the amount of $1,166,210 were received in regard to
this project through December 31, 2002.
On
September 1, 1999, Gluko AG was granted $1,864,383 over a period of three years
to promote the project known as “Development of a permanently implantable
glucose sensor and a controllable insulin pump for diabetics into a technical
beta cell.” In October 2001, an application was submitted to the
project authority, Jülich (PtJ), to have the subsidy period extended until
December 31, 2002; this was approved in a notification of alteration
dated November 28, 2001. SGBI had received funds in regard to this
project amounting to $563,775 through December 31, 2002.
All
remaining funds from both of the above-subsidized projects were returned as of
December 31, 2002.
In the fourth quarter of our fiscal
year ended June 30, 2005, a final project review was carried out by the state
authorities of Northrhine-Westfalia. The review resulted in a final
accounting in our favor totalling to approximately $195,850 for both
projects. $148,810 of this amount was received in the fourth quarter
of our fiscal year ended June 30, 2005, for the oxygen carrier project, and in
the first quarter of the fiscal year ended June 30, 2006 for the glucose sensor
project. The remaining $47,040 was received in the first quarter of
the 2006 fiscal year.
PATENTS AND PROPRIETARY
RIGHTS
The
Company seeks patent protection for all of its research and development, and all
modifications and improvements thereto. As of June 30, 2007
Sangui GmbH had been granted 18 patents. Furthermore, it has applied
for several additional patents, most of which have been filed in Germany (DE),
the United States of America (US), and as an international patent application
with the European Patent Office (EP). Global patent applications are
marked PCT. Two (2) patent applications are related to progress made
in the final development stages of the external application of the artificial
oxygen carriers. Below are listed the most pertinent of the rights
held by the Company.
1.
Haemoglobin-Polymers
EP-P
0 685 492
|
“Process
for the preparation of haemoglobin hyperpolymers of uniform molecular
weight” (Patent Granted)
|
US-A
10/878,724
|
|
|
|
US-P
5,985,332
|
“Hemoglobins
provided with ligands protecting the oxygen binding sites for use as
artificial oxygen carriers for direct application in
medicine
|
EP-P
0857 733
|
and
biolgy, and method for the preparation thereof” (Patent
Granted)
|
|
|
US-O
2004/0014641
|
“Mammalion
haemoglobin compatible with blood plasma, cross-linked and conjugated with
polyalkylene oxides as artificial medical oxygen
|
EP-O
1 299 457
|
carriers, production
and use thereof” (Patent Pending)
|
|
|
US-O
2004/0023851
|
“Method
for the production of artificial oxygen carriers from covalently cross
linking haemoglobin with improved functional properties
|
EP-O
1 249 385
|
of
haemoglobin by cross-linking in the presence of chemically non-reacting
effectors of the oxygen affinity of the haemoglobin” (Patent
Pending)
|
|
|
US-O
2004/0029780
|
“Synthetic
oxygen transport made from cross-linked modified human or porcine
haemoglobin with improved properties, method
|
EP-O
1294386
|
for
a preparation thereof from purified material and use thereof” (Patent
Pending)
|
|
|
PCT-A
103 52 692
|
“Use
of hypo-oncotic solutions of hyperpolymerised haemoglobins to be added to
the human blood circulation in treatment
|
EP
2004/012363
|
of
lung oedema” (Patents Pending)
|
3
2. GlucoTector
US-P
4,775,514
|
“Luminescent
layers for use in apparatus for determining the oxygen concentration in
gases and the like” (Patent Granted)
|
|
|
DE-P
198 15 932
|
“Miniaturisation
of a polarimetre for the analysis of low concentration components in
liquid test materials on an optical
|
|
basis
as well as a device to perform the pertinent tests” (Patent
Granted)
|
|
|
US-P
6,577,393
|
“Polarimetric
procedure for determining the (main) vibration plane of polarized light to
about 0.1 m° and miniaturized
|
DE-P
198 26 294
|
device
for its implmentation” (Patents Granted)
|
|
|
DE-P
199 11 265
|
“Method
for the measurement of the concentration of glucose in aequous solutions
containing proteins, i.e. in interstitial
|
|
tissue
fluids in particular, as well as implantable devices for carrying out said
method” (German Patent Granted)
|
|
|
EP-A
01 940
355
|
“Method
for the long-term stable and well-reproducible spectrometric measurement
of the concentrations of components of
|
DE-P
100 20 615
|
aqueous
solutions, and device for carrying out said method” (German Patent
Granted)
|
|
|
DE-P
100 20 613
|
“Method
and Device for reproducible polarimetric measurement of the concentration
of the components of aequous solutions”
|
|
(German
Patent Granted)
|
|
|
EP-A
01 953
958
|
“Refractometric
method for carrying out long-term stable accurate measurements of the
concentrations of dissolved substances
|
DE-P
100 30 927
|
and
miniaturizable device for carrying out said method” (German Patent
Granted; EP Patent Pending)
|
|
|
US-A
10/312,142
|
“Device
for combined and simultaneous use of several measuring methods for
analysing components of a liquid mixture
|
PCT-O
WO
02/01202
|
of
several substances” (German Patent Granted; EP and US Patents
Pending)
|
DE-P
100 30 920
|
|
3. External applications of
artificial oxygen carriers
EP-P
1 301
169
|
“Preparation
in the form of an emulsion that contains an oxygen carrier selected from
hemoglobin or hemoglobin and myoglobin,
|
US-O
2004/0022839
|
for
use as a topically applicable cosmetic and for the natural regeneration of
the skin in the case of oxygen deficiency” (European Patent
Granted)
|
|
|
EP-P
1 303
297
|
“Preparation
containing an oxygen carrier for regeneration of the skin in the case of
oxygen deficiency” (European Patent Granted)
|
US-O
2003/0180365
|
|
|
|
EP-A
03 740 198
|
“Microemulsions
having a binary phase differentiability and active substance
differentiability, the production thereof and their
use,
|
US-A
10/518,667
|
particularly
for the topical supply of oxygen” (Patents Pending)
|
|
|
DE-O
103 60 503
|
“Combination
set and method for the bio-regenerative treatment of skin” (Patents
Pending)
|
PCT-O
2005 /063193
|
|
4. Wound
Management
EP-A
03 708 173
|
“Use
of one or more natural or modified oxygen carriers, devoid of plasma and
cellular membrane constituents,
|
US-A
10/508,092
|
for
externally treating open, in particular chronic wounds” (Patents
Pending)
|
|
|
PCT-O
2005/063311
|
“Therapeutically
active wound dressings, production thereof, and use of the same” (Patents
Pending)
|
4
MANUFACTURING, MARKETING AND
DISTRIBUTION
For the
manufacturing of our products we rely on certified specialist contract
manufacturers who specialize in the fields of cosmetic and medical
products. Production processes have been certified and comply with
the respective best practices in the industry. Production is
constantly being monitored by us and by the respective certifying
authorities.
We still
have limited experience in the selling and marketing of our
products. We are therefore dependent on attracting industry marketing
and distribution partners in order to succeed in selling our products in their
respective markets.
RESEARCH AND
DEVELOPMENT
Research
and development are charged to operations as they are incurred. Legal
fees and other direct costs incurred in obtaining and protecting patents are
expensed as incurred. Research and development costs totaled $155,886 and
111,608 during the fiscal years ended June 30, 2007 and 2006,
respectively.
GOVERNMENT
REGULATION
SGBI and
its former United States subsidiary were subject to governmental regulation
under the Occupational Safety and Health Act, the Environmental Protection Act,
the Toxic Substances Control Act, and other similar laws of general application,
as to all of which SGBI believes it and its subsidiaries are in material
compliance.
Although
it is believed that SGBI and its United States subsidiary were in material
compliance with all applicable governmental and environmental laws, rules,
regulations and policies, and although no government concerns were put forward
during the operation of or after the closing of the Santa Ana operations, there
can be no assurance that the business, financial condition, and results of
operations of SGBI and its subsidiaries will not be materially adversely
affected by future government claims with regard to unlikely, but not
impossible, infringements on these or other laws resulting from SGBI’s former
United States operations.
Additionally,
the clinical testing, manufacture, promotion and sale of a significant majority
of the products and technologies of the subsidiaries, and to a much less extent
of SGBI, if those products and technologies are to be offered and sold in the
United States, are subject to extensive regulation by numerous governmental
authorities in the United States, principally the Federal Drug Administration
(FDA), and corresponding state regulatory agencies. To the extent
those products and technologies are to be offered and sold in markets other than
the United States, the clinical testing, manufacture, promotion and sale of
those products and technologies will be subject to similar regulation by
corresponding foreign regulatory agencies. In general, the regulatory
framework for biological health care products is more rigorous than for
non-biological health care products. Generally, biological health
care products must be shown to be safe, pure, potent and
effective. There are numerous state and federal statutes and
regulations that govern or influence the testing, manufacture, safety,
effectiveness, labelling, storage, record keeping, approval, advertising,
distribution and promotion of biological health care
products. Non-compliance with applicable requirements can result in,
among other things, fines, injunctions, seizures of products, total or partial
suspension of product marketing, and failure of the government to grant
pre-market approval, withdrawal of marketing approvals, product recall and
criminal prosecution.
COMPETITION
The
market for the products and technologies of SGBI is highly competitive, and SGBI
expects competition to increase. Experiments and clinical testing in
the field of artificial oxygen carriers are being carried out by Alliance
Pharmaceutical Corp. of San Diego, California, as well as Biopure Corp. of
Cambridge, Massachusetts. Companies researching into the possibility
of developing implantable glucose sensors include Roche Diagnostics, Animas,
Corp., Frazer, Pennsylvania, and Medtronic Inc. of Sylmar,
California. In the fields of anti-aging and anti-cellulite cosmetics,
all major cosmetic vendors are actively marketing proprietary
formulations. Leading wound pad providers include Johnson &
Johnson, Bristol-Myers Squibb, as well as Beiersdorf AG.
DEPENDENCE ON MAJOR
CUSTOMERS
As of
June 30, 2007, the company entertained business relationships with three major
customers, Mercatura Biocosmetics AG, Cosmed-Naturell GmbH and Karl Beese GmbH
& Co. No assurance can be given that these companies will be
successful in marketing and distributing our products. These three
companies combined
constitute
approximately 70%
of the
Company’s gross revenues for the year ended June 30,
2007.
HUMAN
RESOURCES
The
Company considers its relations with its employees to be
favorable. As of June 30, 2007 SGBI and its subsidiaries had two
fulltime employees, neither of whom was involved in research and
development. For research and development purposes, the Company had
consulting arrangements with five individuals.
DIVIDENDS
The
Company anticipates that it will use any funds available to finance its growth
and that it will not pay cash dividends to stockholders in the foreseeable
future.
REPORTS TO SECURITY
HOLDERS
Copies of
the Company’s reports, as filed with the Securities and Exchange Commission, are
available and may be viewed as filed at the SEC’s Public Reference Room at 450
Fifth Street, N.W., Washington D.C. 20549 or by calling
1-800-SEC-0330. Additionally they can be accessed and downloaded via
the internet at
http://www.sec.gov/cgi-bin/srch-edgar
by simply typing in “Sangui Biotech International” or via the web links at the
corporate website
http://www.sanguibiotech.com
.
5
The risks
and uncertainties described below are not the only ones facing SGBI and there
may be additional risks that are not presently known or are currently deemed
immaterial. All of these risks may impair business
operations.
The Company's present and proposed
business operations will be highly speculative and subject to the same types of
risks inherent in any new or unproven venture, as well as risk factors
particular to the industries in which it will operate, as well as other
significant risks not normally associated with investing in equity securities of
United States companies, among other things, those types of risk factors
outlined below.
Risk that SGBI's Common Stock may be
deemed a “Penny Stock”
The
Company's common stock may be deemed to be a “penny stock” as that term is
defined in Rule 3a51-1 of the Exchange Act of 1934. Penny stocks are
stocks (i) with a price of less than five dollars per share; (ii) that are not
traded on a “recognized” national exchange; (iii) whose prices are not quoted on
the NASDAQ automated quotation system (NASDAQ-listed stocks must still meet
requirement (i) above); or (iv) of an issuer with net tangible assets of less
than US$2,000,000 or US$5,000,000 (if in continuous operation for less than
three years), or with average annual revenues of less than US$6,000,000 for the
last three years.
A principal exclusion from the
definition of a penny stock is an equity security that has a price of five
dollars ($5.00) or more, excluding any broker or dealer commissions, markups or
markdowns. As of the date of this report SGBI's common stock
has a price less than
$5.00
.
If SGBI's
Common Stock is at any time deemed a penny stock, section 15(g) and Rule 3a51-1
of the Exchange Act of 1934 would require broker-dealers dealing in SGBI's
Common Stock to provide potential investors with a document disclosing the risks
of penny stocks and to obtain a manually signed and dated written receipt of the
document before effecting any transaction in a penny stock for the investor's
account. Potential investors in SGBI's common stock are urged to
obtain and read such disclosure carefully before purchasing any shares that are
deemed to be “penny stock.”
Moreover,
Rule 15g-9 of the Exchange Act of 1934 requires broker-dealers in penny stocks
to approve the account of any investor for transactions in such stocks before
selling any penny stock to that investor. This procedure requires the
broker-dealer to (i) obtain from the investor information concerning his or her
financial situation, investment experience and investment objectives; (ii)
reasonably determine, based on that information, that transactions in penny
stocks are suitable for the investor and that the investor has sufficient
knowledge and experience as to be reasonably capable of evaluating the risks of
penny stock transactions; (iii) provide the investor with a written statement
setting forth the basis on which the broker-dealer made the determination in
(ii) above; and (iv) receive a signed and dated copy of such statement from the
investor, confirming that it accurately reflects the investor's financial
situation, investment experience and investment
objectives. Compliance with these requirements may make it more
difficult for investors in SGBI's common stock to resell their shares to third
parties or to otherwise dispose of them.
Conflicts of Interest; Related Party
Transactions
The
possibility exists that the Company may acquire or merge with a business or
company in which the Company's executive officers, directors, beneficial owners
or their affiliates may have an ownership interest. Although there is
no formal bylaw, stockholder resolution or agreement authorizing any such
transaction, corporate policy does not forbid it and such a transaction may
occur if management deems it to be in the best interests of the Company and its
stockholders, after consideration of all factors. A transaction of
this nature would present a conflict of interest to those parties with a
managerial position and/or an ownership interest in both the Company and the
acquired entity, and may compromise management's fiduciary duties to the
Company's stockholders. An independent appraisal of the acquired
company may or may not be obtained in the event a related party transaction is
contemplated. Furthermore, because management and/or beneficial
owners of the Company's common stock may be eligible for finder's fees or other
compensation related to potential acquisitions by the Company, such compensation
may become a factor in negotiations regarding such potential
acquisitions. It is the Company's intention that all future
transactions be entered into on such terms as if negotiated at arms length,
unless the Company is able to receive more favorable terms from a related
party.
Limited Operating History of the
Company; Losses Are Expected To Continue
There can
be no assurance that unanticipated technical or other problems will not occur
which would result in material delays in product commercialisation or that the
efforts of SGBI will result in successful product
commercialisation. SGBI has been operating at a loss and expects its
costs to increase as soon as its development efforts and testing activities
accelerate. It is currently unknown when profitable operations might be
achieved.
Substantial Doubt that the Company
Can Continue as a Going Concern
The
Company expects to continue to incur significant capital expenses in pursuing
its business plan to market its products and expand its product line, while
obtaining additional financing through stock offerings or other feasible
financing alternatives. In order for the Company to continue its
operations at its existing levels, the Company will require significant
additional funds over the next twelve months. Therefore, the Company
is dependent on funds raised through equity or debt
offerings. Additional financing may not be available on terms
favorable to the Company, or at all. If these funds are not available
the Company may not be able to execute its business plan or take advantage of
business opportunities. The ability of the Company to obtain such
additional financing and to achieve its operating goals is
uncertain. In the event that the Company does not obtain additional
capital or is not able to increase cash flow through the increase of sales,
there is a substantial doubt of its being able to continue as a going
concern.
Future Capital Needs and Uncertainty
of Additional Funding
Although
management believes that SGBI's cash position should be sufficient to cover its
financing for at least the current fiscal year, substantial funds will be
required to effect SGBI's development plans. The Company will require
additional cash for: (i) payment of increased operating expenses; (ii) payment
of development expenses; and (iii) further implementation of its business
strategies. Such additional capital may be raised by additional
public or private financing, as well as borrowings and other
resources. To the extent that additional capital is received by SGBI
by the sale of equity or equity-related securities, the issuance of such
securities will result in dilution to SGBI's shareholders. There can
be no assurance that additional funding will be available on favorable terms, if
at all. SGBI may also seek arrangements with collaborative partners
in order to gain additional funding, marketing assistance or other
contributions. However, such arrangements may require SGBI to
relinquish rights or reduce its interests in certain of its technologies or
product candidates. The inability of SGBI to access the capital
markets or obtain acceptable financing could have a material adverse effect on
the results of operations and financial condition of SGBI. Moreover,
if funds are not available from any sources, SGBI may not be able to continue to
operate. As of June 30, 2007, the Company has issued all of its
common shares of stock as authorized by its Articles. The
Company is unable to consummate any additional sales of common stock until
additional shares are authorized by the Board of Directors, the
shareholders of the Company, and an amendment to the Company’s
Articles of Incorporation is completed.
Dependence on Key
Personnel
The
future success of SGBI will depend on the service of its key scientific
personnel and, additionally, its ability to identify, hire and retain additional
qualified personnel. There is intense competition for qualified
personnel in this industry and there can be no assurance that SGBI will be able
to attract and retain personnel necessary for the development of the business of
SGBI. Because of the intense competition, there can be no assurance
that SGBI will be successful in adding technical personnel if needed to satisfy
its staffing requirements. Failure to attract and retain key
personnel could have a material adverse effect on SGBI.
SGBI and
its subsidiaries are dependent on the efforts and abilities of their senior
management. The loss of various members from management could have a
material adverse effect on the business and prospects of SGBI. In
particular, SGBI will depend on the service of Professor Wolfgang Barnikol
because he is instrumental in his expertise in the development of the oxygen
carrier and glucose sensor products. There can be no assurance that
upon the departure of key personnel from the service of SGBI or its subsidiaries
suitable replacements will be available.
Licenses and
Consents
The
utilization or other exploitation of the products and services developed by SGBI
or its subsidiaries may require SGBI or its subsidiaries to obtain licenses or
consents from the producers or other holders of patents, trademarks, copyrights
or other similar rights (Intellectual Property) relating to the products and
technologies of SGBI or its subsidiaries. In the event SGBI or its
subsidiaries are unable, if so required, to obtain any necessary license or
consent on terms which the management of SGBI or its subsidiaries consider to be
reasonable, SGBI or its subsidiaries may be required to cease developing,
utilizing, or exploiting products or technologies affected by those Intellectual
Property rights. In the event SGBI or its subsidiaries are challenged
by the holders of such Intellectual Property rights, there can be no assurance
that SGBI or its subsidiaries will have the financial or other resources to
defend any resulting legal action, which could be significant.
Technological
Factors
The
market for the products and technology developed by SGBI is characterized by
rapidly changing technology, which could result in product obsolescence or short
product life cycles. Similarly, the industry is characterized by
continuous development and introduction of new products and technology to
replace outdated products and technology. Accordingly, the ability of
SGBI to compete will be dependent upon the ability of SGBI to provide new and
innovative products and technology. There can be no assurance that
competitors will not develop technologies or products that render the proposed
products and technology of SGBI obsolete or less marketable. SGBI
will be required to adapt to technological changes in the industry and develop
products and technology to satisfy evolving industry or customer requirements,
any of which could require the expenditure of significant funds and resources,
and SGBI does not have a source or commitment for any such funds and
resources. Development efforts relating to the technological aspects
of the various products and technologies to be developed by SGBI are not
substantially completed. Accordingly, SGBI will continue to refine
and improve those products and technologies. Continued refinement and
improvement efforts remain subject to the risks inherent in new product
development, including unanticipated technical or other problems, which could
result in material delays in product commercialisation or significantly
increased costs. In addition, there can be no assurance that those
products and technologies will prove to be sufficiently reliable or durable in
wide spread commercial application. The products or technologies
sought to be developed by SGBI will be the result of significant efforts, which
may result in errors that become apparent subsequent to widespread commercial
utilization. In such event, SGBI would be required to modify such
products or technologies and continue with additional research and development,
which could delay the plans of SGBI and cause SGBI to incur additional
cost.
Early Stage of Product Development;
Lack of Commercial Products; No Assurance of Successful Product
Development
The
Company's primary efforts are devoted to the development of proprietary products
involving artificial oxygen carriers and glucose sensors.
The
potential products of SGBI will require additional pre-clinical and clinical
development, regulatory approval and additional investment prior to
commercialisation, either by SGBI independently or by others through
collaborative arrangements. Potential products that appear to be
promising at early stages of development may be ineffective or be shown to cause
harmful side effects during pre-clinical testing or clinical trials, fail to
receive necessary regulatory approvals, be difficult to manufacture, be
uneconomical to produce, fail to achieve market acceptance or be precluded from
commercialisation by proprietary rights of others. There can be no
assurance that any potential products will be successfully developed, prove to
be safe and efficacious in clinical trials, satisfy applicable regulatory
standards, be capable of being produced in commercial quantities at acceptable
costs or achieve commercial acceptance.
All
products and technologies under development by SGBI will require significant
commitment of personnel and financial resources. Several products
will require extensive evaluation and pre-marketing clearance by the Federal
Drug Administration and comparable agencies in other countries prior to
commercial sale. SGBI regularly re-evaluates its product development
efforts. On the basis of these re-evaluations, SGBI may abandon
development efforts for particular products. No assurance can be
given that any product or technology under development will result in the
successful introduction of any new product. The failure to introduce
new products into the market on a timely basis could have a material adverse
effect on the business, financial conditions or results of operation of
SGBI.
There can
be no assurance that human testing of potential products based on such
technologies will be permitted by regulatory authorities or, even if human
testing is permitted, that products based on such technologies will be shown to
be safe and efficacious. Potential products based on the technologies
of SGBI are at an early stage of testing and there can be no assurance that such
products will be shown to be safe or effective.
Market Acceptance
There can
be no assurance that the products and technologies of SGBI will achieve a
significant degree of market acceptance, and that acceptance, if achieved, will
be sustained for any significant period or that product life cycles will be
sufficient (or substitute products developed) to permit SGBI to achieve or
sustain market acceptance which could have a material adverse effect on the
business, financial condition, and results of operations of SGBI.
Government Regulation; No Assurance
of Product Approval
The
clinical testing, manufacture, promotion, and sale of biotechnology and
pharmaceutical products are subject to extensive regulation by numerous
governmental authorities in the United States, principally the Federal Drug
Administration (FDA), and corresponding state and foreign regulatory agencies
prior to the introduction of those products. Management of SGBI
believes that many of the potential products of SGBI will be regulated by the
FDA, subject to the then current regulations of the FDA. Other
federal and state statutes and regulations may govern or influence the testing,
manufacture, safety, effectiveness, labeling, storage, record-keeping, approval,
advertising, distribution and promotion of certain products developed by
SGBI. Non-compliance with applicable requirements can result in,
among other things, fines, injunctions, seizure of products, suspensions of
regulatory approvals, product recalls, operating restrictions, re-labeling
costs, delays in sales, cessation of manufacture of products, the imposition of
civil or criminal sanctions, total or partial suspension of product marketing,
failure of the government to grant pre-market approval, withdrawal of marketing
approvals and criminal prosecution.
The FDA's
requirements include lengthy and detailed laboratory and clinical testing
procedures, sampling activities and other costly and time-consuming
procedures. In particular, human therapeutic products are subject to
rigorous pre-clinical and clinical testing and other approval requirements by
the FDA, and other like agencies in Germany, Singapore and other
countries. Although the time required for completing such testing and
obtaining such approvals is uncertain, satisfaction of these requirements
typically takes a number of years and varies substantially based on the type,
complexity and novelty of each product. Neither SGBI nor its
subsidiaries can accurately predict when product applications or submissions for
FDA or other regulatory review may be submitted. Management of SGBI
has no experience in obtaining regulatory clearance on these types of
products. The lengthy process of obtaining regulatory approval and
ensuring compliance with applicable law requires the expenditure of substantial
resources. Any delays or failure by SGBI or its subsidiaries to
obtain regulatory approval and ensure compliance with appropriate standards
could adversely affect the commercialization of such products, the ability of
SGBI to earn product or royalty revenue, and its results of operations,
liquidity and capital resources.
Pre-clinical
testing is generally conducted in laboratory animals to evaluate the potential
safety and effectiveness of a drug. The results of these studies are
submitted to the FDA, which must be approved before clinical trials can
begin. Typically, clinical evaluation involves a time consuming and
costly three-phase process. In Phase I, clinical trials are conducted
with a small number of subjects to determine the early safety profile, the
pattern of drug distribution and metabolism. In Phase II, clinical
trials are conducted with groups of patients afflicted with a specific disease
in order to determine preliminary efficacy, optimal dosages and expanded
evidence of safety. In Phase III, large-scale, multi-center,
comparative trials are conducted with patients afflicted with a target disease
in order to provide enough data to demonstrate the efficacy and safety required
by the FDA. The FDA closely monitors the progress of each of the
three phases of clinical trials and may, at its discretion, re-evaluate, alter,
suspend or terminate the testing based upon the data which have been accumulated
to that point and its assessment of the risk/benefit ratio to the
patient.
Clinical
trials and the marketing and manufacturing of products are subject to the
rigorous testing and approval processes of the FDA and foreign regulatory
authorities. The process of obtaining FDA and other required
regulatory approvals is lengthy and expensive. There can be no
assurance that SGBI will be able to obtain the necessary approvals to conduct
clinical trials for the manufacturing and marketing of products, that all
necessary clearances will be granted to SGBI or their licensors for future
products on a timely basis, or at all, or that FDA review or other actions will
not involve delays adversely affecting the marketing and sale of the products or
SGBI. In addition, the testing and approval process with respect to
certain new products which SGBI may seek to introduce is likely to take a
substantial number of years and involve the expenditure of substantial
resources. There can be no assurance that pharmaceutical products
currently in development will be cleared for marketing by the
FDA. Failure to obtain any necessary approvals or failure to comply
with applicable regulatory requirements could have a material adverse effect on
the business, financial condition or results of operations of
SGBI. Further, future government regulation could prevent or delay
regulatory approval of the products of SGBI.
There can be
no assurance as to the length of the clinical trial period or the number of
patients the FDA will require to be enrolled in the clinical trials in order to
establish the safety and effectiveness of the products of SGBI. SGBI
may encounter significant delays or excessive costs in their efforts to secure
necessary approvals, and regulatory requirements are evolving and
uncertain. Future United States or foreign legislative or
administrative acts could also prevent or delay regulatory approval of the
products of SGBI. If commercial regulatory approvals are obtained,
they may include significant limitations on the indicated uses for which a
product may be marketed. In addition, a marketed product is subject
to continual FDA review. Later discovery of previously unknown
problems or the failure to comply with the applicable regulatory requirements
may result in restrictions on the marketing of a product, or even the removal of
the product from the market, as well as possible civil or criminal
sanctions. Failure of SGBI to obtain marketing approval for any of
their products under development on a timely basis, or FDA withdrawal of
marketing approval once obtained, could have a material adverse effect on the
business, financial condition and results of operations of SGBI.
Any party
that manufactures therapeutic or pharmaceutical products is required to adhere
to applicable standards for manufacturing practices and to engage in extensive
record keeping and reporting. Any of the manufacturing facilities of
SGBI are subject to periodic inspection by state and federal agencies, including
the FDA and comparable agencies in foreign countries.
The
effect of governmental regulation may be to delay the marketing of new products
for a considerable period of time, to impose costly requirements on the
activities of SGBI or to provide a competitive advantage to other companies that
compete with SGBI. There can be no assurance that FDA or other
regulatory approval for any products developed by SGBI will be granted on a
timely basis, if at all or, if granted, that compliance with regulatory
standards will be maintained. Adverse clinical results by SGBI could
have a negative impact on the regulatory process and timing. A delay
in obtaining, or failure to obtain, regulatory approvals could preclude or
adversely affect the marketing of products and the liquidity and capital
resources of SGBI. The extent of potentially adverse governmental
regulation that might result from future legislation or administrative action
cannot be predicted.
Additionally,
SGBI will be subject to regulatory authorities in Germany and other countries
governing clinical trials and product sales. Even if FDA approval is
obtained, approval of a product by the comparable regulatory authorities of
other countries must be obtained prior to the commencement of marketing the
product in those countries. The approval process varies from country
to country and the time required may be longer or shorter than that required for
FDA approval. The foreign regulatory approval process includes all of
the risks associated with obtaining FDA approval set forth above, and approval
by the FDA does not ensure approval by the health authorities of any other
country. There can be no assurance that any foreign regulatory agency
will approve any product submitted for review by SGBI.
SGBI is
subject to various federal, state and local laws, regulations and
recommendations relating to safe working conditions, laboratory and
manufacturing practices, the experimental use of animals and the use and
disposal of hazardous or potentially hazardous substances, including radioactive
compounds and infectious disease agents, used in connection with its research
work. The extent and character of governmental regulation that might
result from future legislation or administrative action cannot be accurately
predicted.
Intense
Competition
Competition
in the biotechnology, pharmaceutical and cosmetic industries is intense and is
expected to increase. In the field of its medical and cosmetic
products SGBI and its subsidiaries compete directly with the research
departments of biotechnology and pharmaceutical companies, chemical companies
and, possibly, joint collaborations between chemical companies and research and
academic institutions. Management of SGBI is aware that other
companies and businesses have developed and are in the process of developing
technologies and products, which may be competitive with the products and
technologies developed and offered by SGBI. Eventually, this might
include the field of blood additives where there is no direct competition at
present. The biotechnology and pharmaceutical industries continue to
undergo rapid change. There can be no assurance that competitors have
not or will not succeed in developing technologies and products that are more
effective than any which have been or are being developed by SGBI or which would
render the technology and products of SGBI obsolete. Many of the
competitors of SGBI have substantially greater experience, financial and
technical resources and production, marketing and development capabilities than
SGBI. Accordingly, certain of those competitors may succeed in
obtaining regulatory approval for products more rapidly or effectively than
SGBI.
Uncertainties Associated With Patents
and Proprietary Rights
The
success of SGBI and its subsidiaries may depend in part on their ability to
obtain patents for their technologies and products, if any, resulting from the
application of such technologies, to defend patents once obtained and to
maintain trade secrets, both in the United States and in foreign
countries.
The
success of SGBI will also depend upon avoiding the infringement of patents
issued to competitors. There can be no assurance that SGBI will be
able to obtain patent protection for products based upon the technology of
SGBI. Moreover, there can be no assurance that any patents issued to
SGBI or its subsidiaries will not be challenged, invalidated or circumvented or
that the rights granted there under will provide competitive advantages to
SGBI. Litigation, which could result in substantial cost to SGBI, may
be necessary to enforce the patent and license rights of SGBI or to determine
the scope and validity of its and others' proprietary rights.
Due to
the length of time and expense associated with bringing new products through
development and the length of time required for the governmental approval
process, the biotechnology and pharmaceutical industries have traditionally
placed considerable importance on obtaining and maintaining patent and trade
secret protection for significant new technologies, products and
processes. The enforceability of patents issued to biotechnology and
pharmaceutical firms can be highly uncertain. U.S. Federal court
decisions establishing legal standards for determining the validity and scope of
patents in the field are in transition. In addition, there can be no
assurance that patents will be issued or, if issued, any such patents will
afford SGBI protection from infringing patents granted to others.
A number
of biotechnology and pharmaceutical companies, and research and academic
institutions, have developed technologies, filed patent applications or received
patents on various technologies that may be related to the business of SGBI and
its subsidiaries. Some of these technologies, applications or patents
may conflict with the technologies of SGBI. Such conflicts could also
limit the scope of the patents, if any, that SGBI or its subsidiaries may be
able to obtain or result in the denial of the patent applications of
SGBI.
Many of
the competitors of SGBI are, have, or are affiliated with companies having,
substantially greater resources than SGBI, and such competitors may be able to
sustain the costs of complex patent litigation to a greater degree and for
longer periods of time than SGBI. Uncertainties resulting from the
initiation and continuation of any patent or related litigation could have a
material adverse effect on the ability of SGBI to compete in the marketplace
pending resolution of the disputed matters. Moreover, an adverse
outcome could subject SGBI to significant liabilities to third parties and
require SGBI to license disputed rights from third parties or cease using the
technology. In the event that third parties have or obtain rights to
intellectual property or technology used or needed by SGBI, there can be no
assurance that any licenses would be available to SGBI or would be available on
terms reasonably acceptable to SGBI.
SGBI may
rely on certain proprietary technologies, trade secrets, and know-how that are
not patentable. Although SGBI has taken steps to protect their
unpatented trade secrets and technology, in part through the use of
confidentiality agreements with their employees, consultants and certain of its
contractors, there can be no assurance that: (i) these agreements will not be
breached; (ii) SGBI would have adequate remedies for any breach; or (iii) the
proprietary trade secrets and know-how of SGBI will not otherwise become known
or be independently developed or discovered by competitors.
Risk of Product Liability; Potential
Unavailability of Insurance
The
business of SGBI will expose it to potential product liability risks that are
inherent in the testing, manufacturing and marketing of human pharmaceutical and
therapeutic products. SGBI does not currently have product liability
insurance, and there can be no assurance that SGBI will be able to obtain or
maintain such insurance on acceptable terms or, if obtained, that such insurance
will be adequate to cover potential product liability claims or that a loss of
insurance coverage or the assertion of a product liability claim or claims would
not materially adversely affect the business, financial condition and results of
operations of SGBI. SGBI faces an inherent business risk of exposure
to product liability and other claims in the event that the development or use
of its technology or products is alleged to have resulted in adverse
effects. Such risk exists even with respect to those products that
are manufactured in licensed and regulated facilities or that otherwise possess
regulatory approval for commercial sale. There can be no assurance
that SGBI will avoid significant product liability exposure.
While
SGBI has taken, and will continue to take, what it believes are appropriate
precautions, there can be no assurance that it will avoid significant liability
exposure. An inability to obtain product liability insurance at
acceptable cost or to otherwise protect against potential product liability
claims could prevent or inhibit the commercialization of products developed by
SGBI. A product liability claim could have a material adverse effect
on the business, financial condition and results of operations of
SGBI.
Uncertainties Relating to Pricing and
Third-Party Reimbursement
The
operating results of SGBI may depend in part on the availability of adequate
reimbursement for the products of SGBI from third-party payers, such as
government entities, private health insurers and managed care
organizations. Third-party payers are increasingly seeking to
negotiate the pricing of medical services and products. In some
cases, third-party payers will pay or reimburse a user or supplier of a product
for only a portion of the purchase price of the product. In the case
of the products of SGBI, payment or reimbursement by third-party payers of only
a portion of the cost of such products could make such products less attractive,
from a cost perspective, to users, suppliers and physicians. There
can be no assurance that reimbursement, if available, will be
adequate. Moreover, certain of the products of SGBI may not be of the
type generally eligible for third-party reimbursement. If adequate
reimbursement levels are not provided by government entities or other
third-party payers for the products of SGBI, the business, financial condition
and results of operations of SGBI would be materially adversely
affected. A number of legislative and regulatory proposals aimed at
changing the United State's health care system have been proposed in recent
years. While SGBI cannot predict whether any such proposals will be
adopted, or the effect that any such proposal may have on its business, such
proposals, if enacted, could have a material adverse effect on the business,
financial condition or results of operations of SGBI.
Risk of Product Recall; Product
Returns
Product
recalls may be issued at the discretion of SGBI, the FDA or other government
agencies having regulatory authority for product sales and may occur due to
disputed labeling claims, manufacturing issues, quality defects or other
reasons. No assurance can be given that product recalls will not
occur in the future. Any product recall could materially adversely
affect the business, financial condition or results of operations of
SGBI. There can be no assurance that future recalls or returns would
not have a material adverse effect upon the business, financial condition and
results of operations of SGBI.
Risks of International Sales and
Operations
SGBI's
results of operations are subject to fluctuations in the value of the Euro
against the U.S. Dollar due to SGBI's German subsidiaries. Although
management of SGBI will monitor exposure to currency fluctuations, there can be
no assurance that exchange rate fluctuations will not have a material adverse
effect on the results of operations or financial condition of
SGBI. In the future, SGBI could be required to sell its products in
other currencies, which would make the management of currency fluctuations more
difficult and expose SGBI to greater risks in this regard.
The
products of SGBI will be subject to numerous foreign government standards and
regulations that are continually being amended. Although SGBI will
endeavor to satisfy foreign technical and regulatory standards, there can be no
assurance that the products of SGBI will comply with foreign government
standards and regulations, or changes thereto, or that it will be cost effective
for SGBI to redesign its products to comply with such standards or
regulations. The inability of SGBI to design or redesign products to
comply with foreign standards could have a material adverse effect on SGBI's
business, financial condition and results of operations.
Lack of Commercial Manufacturing and
Marketing Experience
SGBI has
not yet manufactured its products in commercial quantities. The
Company and its manufacturing contractors and partners will be engaged in
manufacturing pharmaceutical products which will be subject to stringent
regulatory requirements. No assurance can be given that the Company,
on a timely basis, will be able to make the transition from manufacturing
clinical trial quantities to commercial production quantities successfully or be
able to arrange for contract manufacturing. SGBI and its subsidiaries
have no experience in the sales, marketing and distribution of
products. There can be no assurance that SGBI will be able to
establish sales, marketing and distribution capabilities or make arrangements
with collaborators, licensees or others to perform such activities or that such
effort will be successful.
The
manufacture of the products of SGBI involves a number of steps and requires
compliance with stringent quality control specifications imposed by SGBI and by
the FDA or similar regulatory bodies under the law of the respective
countries. Moreover, SGBI's products can only be manufactured in a
facility that has undergone a satisfactory inspection by the FDA. For
these reasons, SGBI would not be able to quickly replace its manufacturing
capacity if one of its manufacturing contractors or partners were unable to use
their manufacturing facilities as a result of a fire, natural disaster,
equipment failure or other difficulty, or if such facilities are deemed not in
compliance with the FDA's Good Manufacturing Practice (GMP) requirements and the
non-compliance could not be rapidly rectified. The inability or
reduced capacity of SGBI to manufacture their products would have a material
adverse effect on SGBI's business and results of operations.
SGBI has
entered and may enter into arrangements with contract manufacturing companies to
expand its production capacities in order to satisfy requirements for its
products, or to attempt to improve manufacturing efficiency. If SGBI
chooses to contract for manufacturing services and encounters delays or
difficulties in establishing relationships with manufacturers to produce,
package and distribute its finished products, clinical trials, market
introduction and subsequent sales of such products would be adversely
affected. Further, contract manufacturers must also operate in
compliance with the FDA's GMP requirements; failure to do so could result in,
among other things, the disruption of product supplies.
Currently,
SGBI has its products manufactured by contract manufacturers in Germany and
anticipates future production in Mexico. No assurance can be given,
that these vendors will be willing or able to produce the products in the
required quality or quantitities or at prices which will enable SGBI to sell the
end products as requested by its customers.
Hazardous Materials And Environmental
Matters
The
research and development processes of SGBI involve the controlled storage, use
and disposal of hazardous materials. SGBI is subject to federal,
state and local laws and regulations governing the use, generation,
manufacturing, storage, handling, and disposal of such materials and certain
waste products. Although SGBI does not currently manufacture
commercial quantities of its product candidates, it produces limited quantities
of such products for its clinical trials or comparable testing and SGBI may
eventually intend to manufacture commercial quantities of its
products. Although SGBI has passed the ISO 9001:2000 (General Quality
Management System) and ISO 13485:2003 (Quality Management System Medical
Products) audits, and obtained the respective certifications, and although it
believes that its safety procedures for handling and disposing of such materials
comply with the standards prescribed by such laws and regulations, the risk of
accidental contamination or injury from these materials cannot be completely
eliminated. In the event of such an accident, SGBI could be held
liable for any damages that result, and any such liability could exceed the
resources of SGBI. There can be no assurance that SGBI will not be
required to incur significant costs to comply with current or future
environmental laws and regulations nor that the operations, business or assets
of SGBI will not be materially or adversely affected by current or future
environmental laws or regulations.
Fluctuations in Foreign Currency
Exchange Rates could have an Adverse Impact.
Because a
portion of our total revenue is derived from international operations that are
conducted in foreign currencies, changes in value of these foreign currencies
relative to the US dollar may affect our results of operation and financial
position. If for any reason exchange or price controls or other
restriction on the conversion of foreign currencies were imposed, our business
could be adversely affected.
ITEM 2.
PROPERTIES
The
Company leases its office and laboratory facilities and is housed in
approximately 8,600 square feet based in the Forschungs-und Entwicklungszentrum
of the University Witten/Herdecke, Germany. Rent expense was
approximately $78,000 and $68,000 during the years ended June 30, 2007 and 2006,
respectively.
ITEM 3.
LEGAL
PROCEEDINGS
On February
14, 2007, Dr. Rainer Felfe, filed a claim (4 Ca 431/07) against the Company and
its subsidiary, SanguiBioTech GmbH, with the Industrial Relations Court in
Bochum, Germany (Arbeitsgericht Bochum). Dr. Felfe's claim states that he is
entitled to receive outstanding wages and salaries owed to Prof. Dr. Dr.
Wolfgang Barnikol by the Company, or its subsidiary, in the amount of
approximately 370,000 euros (approximately US $503,200) as partial relief of a
judgment rendered in a civil case against Dr. Barnikol (Oberlandesgericht
Düsseldorf I 6 U 96/06). Dr. Barnikol has never made a claim against the
Company, or its subsidiary, for outstanding wages with any governmental agency
and acknowledges there are no outstanding wages are due to him by either the
Company or its subsidiary. The claim by Dr. Felfe has been declared pending by
the Industrial Relations Court until a final judgment is rendered by the Federal
Supreme Court in the appeal to the above civil case. The Company believes the
claim lacks merit and plans to vigorously defend this claim.
The
Company is not aware of pending claims or assessments, other than as described
above, which may have a material adverse impact on the Company’s financial
position or results of operations.
ITEM 4.
SUBMISSION OF
MATTERS TO A VOTE OF SECURITY HOLDERS
No matter
was submitted to our security holders for approval during the period covered by
this Report.
PART
II
ITEM 5.
MARKET FOR
COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND SMALL BUSINESS ISSUER PURCHASES
OF EQUITY SECURITIES
As of
June 30, 2007, SGBI's common stock was traded on
www.pinksheets.com
under the symbol SGBI as well as on the OTC market of the Hamburg stock exchange
in Germany.
The
following table sets forth the high and low closing prices for shares of SGBI
common stock for the fiscal periods noted, as reported by
www.pinksheets.com
. Quotations
reflect inter-dealer prices, without retail mark-up, markdown or commissions and
may not represent actual transactions.
|
|
|
CLOSING PRICES
(US$)
|
|
FISCAL
YEAR
|
PERIOD
|
|
HIGH
|
|
|
LOW
|
|
|
|
|
|
|
|
|
|
2007
|
July
- September
|
|
|
0.16
|
|
|
|
0.11
|
|
|
October
- December
|
|
|
0.30
|
|
|
|
0.12
|
|
|
January
- March
|
|
|
0.27
|
|
|
|
0.175
|
|
|
April
– June
|
|
|
1.01
|
|
|
|
0.20
|
|
2006
|
July
- September
|
|
|
0.22
|
|
|
|
0.13
|
|
|
October
- December
|
|
|
0.15
|
|
|
|
0.10
|
|
|
January
- March
|
|
|
0.20
|
|
|
|
0.11
|
|
|
April
– June
|
|
|
0.16
|
|
|
|
0.10
|
|
In addition
to freely tradable shares, SGBI has numerous shares of common stock outstanding
that could be sold pursuant to Rule 144. In general, under Rule 144,
subject to the satisfaction of certain other conditions, a person, including one
of our affiliates, who has beneficially owned restricted shares of common stock
for at least one year is entitled to sell, in certain brokerage transactions,
within any three-month period, a number of shares that does not exceed the
greater of 1% of the total number of outstanding shares of the same class, or
the average weekly trading volume during the four calendar weeks immediately
preceding the sale. A person who presently is not and who has not
been an affiliate for at least three months immediately preceding the sale and
who has beneficially owned the shares of common stock for at least two years is
entitled to sell such shares under Rule 144 without regard to any of the volume
limitations described above.
At June 30,
2007, the number of record holders of the Company's common stock was
approximately 875. The Company did not pay any cash dividends during
the past two fiscal years and does not contemplate paying dividends in the
foreseeable future.
RECENT SALES OF UNREGISTERED
SECURITIES
Sales of
Securities
In January, 2006, the
company sold 1,496,251 shares of common stock to one Swiss investor yielding a
cash contribution in the amount of $135,758. The issuance was not
involving a public offering the offer and sale of the shares occurred outside of
the United States and the shares were sold and issued to individuals who reside
outside of the United States, pursuant to an exemption from registration under
Rule 901, Regulation S of the Securities Act of 1933, as amended.
ITEM 6. MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION OR PLAN OF
OPERATIONS
CRITICAL
ACCOUNTING POLICIES AND ESTIMATES
The
preparation of consolidated financial statements in conformity with accounting
principles generally accepted in the United States requires us to make estimates
and judgments that affect the reported amounts of assets, liabilities, revenue,
expenses, and related disclosure of contingent assets and
liabilities. We believe the following critical accounting policies
affect our more significant judgments and estimates used in the preparation of
our consolidated financial statements. Actual results may differ from
these estimates under different assumptions or conditions.
CRITICAL ACCOUNTING
POLICIES Our significant accounting policies are described in Note 1 to
the consolidated financial statements for the year ended June 30,
2007. The following are our critical accounting
policies:
Revenue
Recognition
Revenue is recognized
when the sales amount is determined, shipment of goods to the customer has
occurred and collection is reasonably assured. Product is shipped FOB
origination.
Research
and Development
Research and
development are charged to operations as they are incurred. Legal
fees and other direct costs incurred in obtaining and protecting patents are
expensed as incurred. Research and development costs totaled $155,886 and
$111,608 during the fiscal years ended June 30, 2007 and 2006,
respectively.
Foreign
Currency Translation
Assets and
liabilities of the Company's foreign operations are translated into U.S. dollars
at period-end exchange rates. Net exchange gains or losses resulting
from such translation are excluded from net loss but are included in
comprehensive income (loss) and accumulated in a separate component of
stockholders' equity. Income and expenses are translated at weighted
average exchange rates for the period.
New
Accounting Pronouncements
In December
2004, the FASB issued SFAS No. 123R "Shared Based Payment". This statement is a
revision of SFAS Statement No. 123, "Accounting for Stock-Based Compensation"
and supersedes APB Opinion No. 25, "Accounting for Stock Issued to Employees,"
and its related implementation guidance. SFAS 123R addresses all forms of shared
based payment ("SBP") awards, including shares issued under employee stock
purchase plans, stock options, restricted stock and stock appreciation rights.
Under SFAS 123R, SBP awards result in a cost that will be measured at fair value
on the awards' grant date, based on the estimated number of awards that are
expected to vest and will be reflected as compensation cost in the historical
financial statements. This statement is effective for public entities as of the
beginning of the first interim or annual reporting period that begins after June
15, 2005.
In May 2005,
the FASB issued Statement of Financial Accounting Standards No. 154
“Accounting
Changes and Error Corrections, an amendment of APB Opinion 20 and FASB Statement
No. 3,”
which changes the requirements for accounting for and reporting
on a change in accounting principle. This statement is effective for accounting
changes and corrections of errors made in fiscal years beginning after December
15, 2005. We believe that the adoption of SFAS No. 154 will not have a material
impact on our results of operations.
In March
2006, the FASB issued SFAS No. 156
“Accounting
for Servicing of Financial Assets, an amendment of FASB No. 140,”
which
modifies the accounting for and reporting of servicing asset and servicing
liabilities. This statement is effective as of the beginning of our first fiscal
year that begins after September 15, 2006. SFAS No. 156 is not currently
applicable to the company and, we believe that the adoption of SFAS No. 156 will
not have a material impact on our results of operations.
In June 2006,
the FASB issued Financial Interpretation No. (FIN) 48, “
Accounting for
Uncertainty in Income Taxes - an interpretation of FASB Statement 109
.”
FIN 48 prescribes a recognition threshold and a measurement attribute for the
financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. This interpretation also provides guidance
on de-recognition, classification, interest and penalties, accounting in interim
periods, disclosure and transition. This interpretation is effective for fiscal
years beginning after December 15, 2006. The Company is currently evaluating the
impact of applying the various provisions of FIN 48.
In September 2006,
the FASB issued SFAS No. 157, “
Fair Value
Measurements
,”
that provides guidance for using fair value
to measure assets and liabilities. Under SFAS 157, fair value refers to the
price that would be received to sell an asset or paid to transfer a liability in
an orderly transaction between market participants in the market in which the
reporting entity transacts. SFAS 157 establishes a fair value hierarchy that
prioritizes the information used to develop the assumptions that market
participants would use when pricing the asset or liability. The fair value
hierarchy gives the highest priority to quoted prices in active markets and the
lowest priority to unobservable data. In addition, SFAS 157 requires that fair
value measurements be separately disclosed by level within the fair value
hierarchy. This standard will be effective for financial statements issued for
fiscal periods beginning after November 15, 2007 and interim periods within
those fiscal years. The Company is currently evaluating the impact of applying
the various provisions of SFAS 157.
FINANCIAL
POSITION
The Company’s
current assets increased by $89,198, or 126%, from June 30, 2006
to $160,127 at June 30, 2007. The increase is primarily
attributable to a significant increase in inventory, prepaid expenses, and
accounts receivable.
The Company's
net property and equipment decreased $7,178 or 61%, from June 30, 2006 to $4,530
at June 30, 2007. The decrease is primarily attributable to the
current year depreciation of approximately $21,540, partially offset by $14,110
in purchases of new property and equipment during the year.
The Company
funded its operations primarily through borrowings on promissory notes
payable. The Company’s stockholders’ equity increased $27,114, to a
deficit of $410,818. The primary increase is caused by the Company's
current year net loss of $721,562.
REVENUES. Revenues
increased 171% to $372,015 during the year ended June 30, 2007 from $137,257
during 2006. This increase is due primarily to the company’s
increased emphasis on sales and exploitation of existing research and
development. The Company incurred Cost of Sales totaling $256,805
during the 2007 fiscal year, a 118% increase over the prior year.
RESEARCH AND
DEVELOPMENT.
Research
and development expenses increased 40% to $155,886 during the year ended June
30, 2007 from $111,608 during the 2006 fiscal year. This increase is due
primarily to the Company working to improve and perfect its current inventory
items in addition to further developing various new inventory products utilizing
its existing technology and production methods
.
GENERAL AND
ADMINISTRATIVE. General and administrative expenses increased 9% to
$665,884 in 2007 from $609,949 in 2006. This increase of $55,935 is
attributed to increases in legal and accounting expenses, as well as expenses
incurred in pursuing new international markets for the Company’s products, as
well as in the US dollar weakening against the EURO.
NET
LOSS. As a result of the above factors, the Company's consolidated
net loss was approximately $722,000, or $0.02 per common share in 2007, compared
to $731,000, or $0.02 per common share, in 2006.
LIQUIDITY
AND CAPITAL RESOURCES
For the year
ended June 30, 2007, net cash used in operating activities increased to $755,925
from $282,936 for the year ended June 30, 2006, primarily related to significant
changes in prepaid expenses, inventory, and in current liabilities during the
2007 fiscal year.
For the year
ended June 30, 2007, net cash flows from investing activities decreased to an
outflow of $20,328, from a outflow of $7,530 for the year ended June 30,
2006. The principal reason for the decrease was the purchase of
equipment items during the 2007 fiscal year.
The Company
had a working capital deficit of $515,437 at June 30, 2007, compared to working
capital deficit of $436,681 at June 30, 2006, an overall decrease of $78,756,
due primarily to the Company’s net loss for the year.
The Company
incurred a net loss applicable to common stockholders of $721,562 and used cash
in operating activities of $755,925 for the year ended June 30,
2007. These and other conditions raise substantial doubt about the
Company's ability to continue as a going concern. The Company expects
to continue to incur significant capital expenses in pursuing its business plan
to market its products and expand its product line, while obtaining additional
financing through stock offerings or other feasible financing
alternatives. In order for the Company to continue its operations at
its existing levels, the Company will require significant additional funds over
the next twelve months. Therefore, the Company is dependent on funds
raised through equity or debt offerings. Additional financing may not
be available on terms favorable to the Company, or at all. If these
funds are not available the Company may not be able to execute its business plan
or take advantage of business opportunities. The ability of the
Company to obtain such additional financing and to achieve its operating goals
is uncertain. In the event that the Company does not obtain
additional capital or is not able to increase cash flow through the increase of
sales, there is a substantial doubt of its being able to continue as a going
concern. The accompanying condensed consolidated financial statements
do not include any adjustments that might result from the outcome of this
uncertainty.
Sales of our
anti-aging formulation started in early 2005, sales of our product skin
regeneration as well as wound pad products started in the course of the first
quarter of 2007. The current state of the different sales efforts has induced
management to believe that revenues from these products may be obtainable in the
course of the current fiscal year. However, the Company will need
substantial additional funding to fulfill its business plan and the Company
intends to explore financing sources for its future development
activities. No assurance can be given that these efforts will be
successful.
13
ITEM 7.
FINANCIAL
STATEMENTS
SANGUI
BIOTECH INTERNATIONAL, INC.
CONSOLIDATED
FINANCIAL STATEMENTS
June 30,
2007
14
MOORE & ASSOCIATES, CHARTERED
ACCOUNTANTS
AND ADVISORS
PCAOB
REGISTERED
REPORT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors
Sangui
Biotech International, Inc.
We have
audited the accompanying consolidated balance sheet of Sangui Biotech
International, Inc. as of June 30, 2007, and the related consolidated statements
of operations, stockholders’ equity and cash flows for the years ended June 30,
2007 and June 30, 2006. 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 audits.
We
conduct our audits in accordance with standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan
and perform the audits 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 audits 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 Sangui Biotech
International, Inc. as of June 30, 2007, and the related statements of
operations, stockholders’ equity and cash flows for the years ended June 30,
2007 and June 30, 2006, 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 1 to the
financial statements, the Company has incurred a net loss applicable to common
stockholders of $721,562 and used cash in operating activities of $755,925 for
the year ended June 30, 2007, which raises substantial doubt about its ability
to continue as a going concern. Management’s plans concerning these
matters are also described in Note 1. The financial statements do not
include any adjustments that might result from the outcome of this
uncertainty.
/s/
Moore & Associates, Chartered
Moore
& Associates Chartered
Las
Vegas, Nevada
July 30,
2008
2675 S. Jones Blvd. Suite
109, Las Vegas, NV 89146 (702) 253-7499 Fax (702) 253-7501
15
SANGUI BIOTECH INTERNATIONAL, INC.
|
|
Consolidated
Balance Sheet
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
June
30,
|
|
|
2007
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
|
Cash
|
|
$
|
18,497
|
|
Accounts
receivable
|
|
|
36,387
|
|
Inventory
|
|
|
88,353
|
|
Prepaid
expenses and other assets
|
|
|
16,890
|
|
|
|
|
|
|
Total
Current Assets
|
|
|
160,127
|
|
|
|
|
|
|
FIXED
ASSETS, Net
|
|
|
4,530
|
|
|
|
|
|
|
OTHER
ASSETS
|
|
|
|
|
|
|
|
|
|
Tax
refunds receivable
|
|
|
6,218
|
|
Deposits
|
|
|
93,871
|
|
|
|
|
|
|
Total
Other Assets
|
|
|
100,089
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$
|
264,746
|
|
The
accompanying notes are an integral part of these consolidated financial
statements.
SANGUI
BIOTECH INTERNATIONAL, INC.
|
|
Consolidated
Balance Sheet (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
|
2007
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
$
|
427,688
|
|
Notes
payable - related
|
|
|
134,742
|
|
Notes
payable
|
|
|
113,134
|
|
|
|
|
|
|
Total
Current Liabilities
|
|
|
675,564
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
|
675,564
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
Preferred stock, no par value; 5,000,000 shares
|
|
|
|
|
authorized, -0- shares issued and outstanding
|
|
|
-
|
|
Common stock, no par value; 50,000,000 shares
|
|
|
|
|
authorized, 50,000,000 shares issued and outstanding
|
|
|
18,969,358
|
|
Additional paid-in capital
|
|
|
1,958,376
|
|
Treasury
stock
|
|
|
-
|
|
Accumulated other comprehensive income
|
|
|
1,147,882
|
|
Accumulated deficit
|
|
|
(22,486,434
|
)
|
|
|
|
|
|
Total
Stockholders' Equity (Deficit)
|
|
|
(410,818
|
)
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS'
|
|
|
|
|
EQUITY
(DEFICIT)
|
|
$
|
264,746
|
|
The
accompanying notes are an integral part of these consolidated financial
statements.
SANGUI BIOTECH INTERNATIONAL, INC.
|
|
Consolidated
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
For
the Years Ended
|
|
|
|
June
30,
|
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
|
|
|
REVENUES
|
|
$
|
372,015
|
|
|
$
|
137,257
|
|
|
|
|
|
|
|
|
|
|
COST
OF SALES
|
|
|
256,805
|
|
|
|
118,018
|
|
|
|
|
|
|
|
|
|
|
GROSS
PROFIT
|
|
|
115,210
|
|
|
|
19,239
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
155,886
|
|
|
|
111,608
|
|
Depreciation
and amortization
|
|
|
21,540
|
|
|
|
36,876
|
|
General
and administrative
|
|
|
665,884
|
|
|
|
609,949
|
|
|
|
|
|
|
|
|
|
|
Total
Operating Expenses
|
|
|
843,310
|
|
|
|
758,433
|
|
|
|
|
|
|
|
|
|
|
OPERATING
LOSS
|
|
|
(728,100
|
)
|
|
|
(739,194
|
)
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSE)
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
90
|
|
|
|
96
|
|
Interest
expense
|
|
|
(23,676
|
)
|
|
|
(12,087
|
)
|
Other
income (loss)
|
|
|
30,124
|
|
|
|
19,699
|
|
|
|
|
|
|
|
|
|
|
Total
Other Income (Expense)
|
|
|
6,538
|
|
|
|
7,708
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS BEFORE INCOME TAXES
|
|
|
(721,562
|
)
|
|
|
(731,486
|
)
|
PROVISION
FOR INCOME TAXES
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
|
(721,562
|
)
|
|
|
(731,486
|
)
|
|
|
|
|
|
|
|
|
|
OTHER
COMPREHENSIVE INCOME
|
|
|
|
|
|
|
|
|
Foreign
currency translation adjustments
|
|
|
1,147,882
|
|
|
|
70,027
|
|
Unrealized
gain on marketable securities
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total
Other Comprehensive Income (Loss)
|
|
|
1,147,882
|
|
|
|
70,027
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE
INCOME (LOSS)
|
|
$
|
426,320
|
|
|
$
|
(661,459
|
)
|
|
|
|
|
|
|
|
|
|
BASIC
AND DILUTED
|
|
|
|
|
|
|
|
|
LOSS
PER SHARE
|
|
$
|
(0.01
|
)
|
|
$
|
(0.02
|
)
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE
|
|
|
|
|
|
|
|
|
NUMBER
OF SHARES
|
|
|
|
|
|
|
|
|
OUTSTANDING
|
|
|
50,000,000
|
|
|
|
48,751,875
|
|
The accompanying notes are an
integral part of these consolidated financial statements.
18
SANGUI BIOTECH INTERNATIONAL, INC.
|
|
Consolidated
Statements of Stockholders' Equity (Deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
Common
Stock
|
|
|
Paid-In
|
|
|
Treasury
|
|
|
Comprehensive
|
|
|
Accumulated
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Stock
|
|
|
Income
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
June 30, 2005
|
|
|
47,503,749
|
|
|
$
|
18,746,100
|
|
|
$
|
1,986,398
|
|
|
$
|
82,357
|
|
|
$
|
383,407
|
|
|
$
|
(21,033,386
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
shares issued for
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
cash
at $0.0875 per share
|
|
|
1,000,000
|
|
|
|
87,500
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
shares issued for
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
prepaid
consulting fees at
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.0908
per share
|
|
|
1,496,251
|
|
|
|
135,758
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale
of treasury stock
|
|
|
-
|
|
|
|
-
|
|
|
|
(28,022
|
)
|
|
|
(82,357
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency
translation adjustment
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
70,027
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the year ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30, 2006
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(731,486
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
June 30, 2006
|
|
|
50,000,000
|
|
|
|
18,969,358
|
|
|
|
1,958,376
|
|
|
|
-
|
|
|
|
453,434
|
|
|
|
(21,764,872
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency
translation adjustment
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
694,448
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss for the year ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30, 2007
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(721,562
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
June 30, 2007
|
|
|
50,000,000
|
|
|
$
|
18,969,358
|
|
|
$
|
1,958,376
|
|
|
$
|
-
|
|
|
$
|
1,147,882
|
|
|
$
|
(22,486,434
|
)
|
The accompanying notes are
an integral part of these consolidated financial
statements.
19
SANGUI BIOTECH INTERNATIONAL, INC.
|
|
Statements
of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For
the Years Ended
|
|
|
|
June
30,
|
|
|
|
2007
|
|
|
2006
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(721,562
|
)
|
|
$
|
(731,485
|
)
|
Adjustments
to reconcile net loss to net cash
|
|
|
|
|
|
|
|
|
used
by operating activities:
|
|
|
|
|
|
|
|
|
Depreciation,
depletion and amortization
|
|
|
21,288
|
|
|
|
36,876
|
|
Changes
in operating assets and liabilities
|
|
|
|
|
|
|
|
|
Increase
in accounts receivable
|
|
|
(19,786
|
)
|
|
|
(12,301
|
)
|
Increase
in inventory
|
|
|
(73,633
|
)
|
|
|
(7,657
|
)
|
Increase
in prepaid expenses and other assets
|
|
|
(54,432
|
)
|
|
|
244,488
|
|
Increase
in accounts payable and accrued expenses
|
|
|
92,200
|
|
|
|
187,143
|
|
|
|
|
|
|
|
|
|
|
Net
Cash Used by Operating Activities
|
|
|
(755,925
|
)
|
|
|
(282,936
|
)
|
|
|
|
|
|
|
|
|
|
INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases
of patents and licenses
|
|
|
(6,218
|
)
|
|
|
-
|
|
Purchases
of fixed assets
|
|
|
(14,110
|
)
|
|
|
(7,530
|
)
|
|
|
|
|
|
|
|
|
|
Net
Cash Used by Investing Activities
|
|
|
(20,328
|
)
|
|
|
(7,530
|
)
|
|
|
|
|
|
|
|
|
|
FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change
in notes payable
|
|
|
(58,988
|
)
|
|
|
147,990
|
|
Change
in notes payable - related
|
|
|
134,742
|
|
|
|
-
|
|
Sale
of common stock for cash
|
|
|
-
|
|
|
|
87,500
|
|
|
|
|
|
|
|
|
|
|
Net
Cash Provided by Financing Activities
|
|
|
75,754
|
|
|
|
235,490
|
|
|
|
|
|
|
|
|
|
|
EFFECTS
OF EXCHANGE RATES
|
|
|
694,448
|
|
|
|
70,027
|
|
|
|
|
|
|
|
|
|
|
NET
DECREASE IN CASH
|
|
|
(6,051
|
)
|
|
|
15,051
|
|
|
|
|
|
|
|
|
|
|
CASH
AT BEGINNING OF PERIOD
|
|
|
24,548
|
|
|
|
9,497
|
|
|
|
|
|
|
|
|
|
|
CASH
AT END OF PERIOD
|
|
$
|
18,497
|
|
|
$
|
24,548
|
|
|
|
|
|
|
|
|
|
|
SUPPLIMENTAL
DISCLOSURES OF
|
|
|
|
|
|
|
|
|
CASH
FLOW INFORMATION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
PAID FOR:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
-
|
|
|
$
|
-
|
|
Income
Taxes
|
|
$
|
-
|
|
|
$
|
-
|
|
The accompanying notes are an
integral part of these consolidated financial statements.
20
SANGUI BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE 1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature of
Business
Sangui
Biotech International, Inc., incorporated in Colorado in 1995, and its wholly
owned subsidiaries, Sangui Biotech, Inc., SanguiBioTech AG, GlukoMediTech AG,
and Sangui BioTech PTE Ltd., (collectively, the "Company") have been engaged in
the research, development, manufacture, and sales of medical
products.
On June 30,
2003, GlukoMediTech AG ("Gluko AG") was merged into Sangui BioTech AG ("Sangui
AG"). Effective November 4, 2003, Sangui AG was converted into Sangui BioTech
GmbH (Sangui GmbH). After completion of the restructuring, Sangui GmbH, which is
headquartered in Witten, Germany, is engaged in the development of artificial
oxygen carriers (external applications of haemoglobin, blood substitutes and
blood additives) and in the development of glucose implant sensors.
The
operations of Sangui BioTech, Inc. ("Sangui USA") were discontinued during 2002
upon the sale of its in vitro immunodiagnostics business and the subsequent
merger of Sangui USA with and into the parent company, Sangui BioTech
International, Inc., effective December 31, 2002 (see Note 7). Sangui BioTech
PTE Ltd ("Sangui Singapore") was a regional office for the Company that carried
out research and development projects in conjunction with Sangui GmbH and Sangui
Singapore. The Company discontinued the operations of Sangui Singapore in August
2002. The Singapore office was closed effective December 31, 2002.
The Company
incurred a net loss applicable to common stockholders of $721,562 and used cash
in operating activities of $755,925 for the year ended June 30,
2007. These, and other conditions raise substantial doubt about the
Company's ability to continue as a going concern. The Company expects to
continue to incur significant capital expenses in pursuing its business plan to
market its products and expand its product line, while obtaining additional
financing through stock offerings or other feasible financing alternatives. In
order for the Company to continue its operations at its existing levels, the
Company will require significant additional funds over the next twelve months.
Therefore, the Company is dependent on funds raised through equity or debt
offerings.
Additional
financing may not be available on terms favorable to the Company, or at all. If
these funds are not available the Company may not be able to execute its
business plan or take advantage of business opportunities. The ability of the
Company to obtain such additional financing and to achieve its operating goals
is uncertain. In the event that the Company does not obtain additional capital
or is not able to increase cash flow through the increase of sales, there is a
substantial doubt of its being able to continue as a going concern. The
accompanying consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Consolidation
The
consolidated financial statements include the accounts of Sangui BioTech
International, Inc. and its wholly owned domestic and foreign subsidiaries. All
significant intercompany accounts and transactions have been eliminated in
consolidation.
21
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE 1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of
Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses
during the respective reporting period. Actual results could differ from those
estimates. Significant estimates made by management are, among others, the
realization of receivables and long-lived assets, and valuation allowance on
deferred tax assets.
Risks and
Uncertainties
The Company's
line of future pharmaceutical and cosmetic products (artificial oxygen carriers
or blood substitute and additives) as well as other medical products being
developed by Sangui GmbH, are deemed as medical devices or biologics, and as
such are governed by the Federal Food and Drug and Cosmetics Act and by the
regulations of state agencies and various foreign government agencies. The
pharmaceutical and biosensor products, under development in Germany, will be
subject to more stringent regulatory requirements, because they are in vivo
products for humans. The Company and its subsidiaries have no experience in
obtaining regulatory clearance on these types of products. Therefore, the
Company will be subject to the risks of delays in obtaining or failing to obtain
regulatory clearance.
Financial
Instruments
The Company
has financial instruments whereby the fair market value of the financial
instruments could be different than that recorded on a historical basis. The
Company's financial instruments consist of its cash and cash equivalents,
marketable securities, and accounts payable and accrued expenses. The
carrying amount of the Company's cash and cash equivalents and accounts payable
and accrued expenses approximate their estimated fair values due to the
short-term nature of these financial statements. Marketable securities are
stated at fair value based upon quoted market prices and are classified as
available-for-sale securities.
Foreign
Currency Translation
Assets and
liabilities of the Company's foreign operations are translated into U.S. dollars
at period-end exchange rates. Net exchange gains or losses resulting from such
translation are excluded from net loss but are included in comprehensive income
(loss) and accumulated in a separate component of stockholders' equity. Income
and expenses are translated at weighted average exchange rates for the
period.
Cash and
Cash Equivalents
The Company
maintains its cash in uninsured bank accounts in Germany. Cash and cash
equivalents include time deposits for which the Company has no requirements for
compensating balances. The Company has not experienced any losses in its
uninsured bank accounts. The Company had no cash equivalents
outstanding as of June 30, 2007.
22
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE 1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Property
and Equipment
Property and
equipment are recorded at cost and are depreciated or amortized using the
straight-line method over the expected useful lives, which range from three to
five years. Leasehold improvements are amortized using the straight-line method
over the lesser of the estimated useful lives of the assets or the related lease
terms. Depreciation expense for the years ended June 30, 2007 and 2006 was
$21,540 and $36,876, respectively. Expenditures for normal maintenance and
routine repairs are charged to expense, and significant improvements are
capitalized. The cost and related accumulated depreciation of assets are removed
from the accounts upon retirement or other disposition; any resulting gain or
loss is reflected in the statement of operations.
Patents
and Licenses
Patents and
licenses are recorded at cost and are amortized using the straight-line method
over their estimated useful lives, which range from four to eight years.
Amortization expense for the years ended June 30, 2007 and 2006 was
$-0-.
Impairment
of Long-Lived Assets
Long-lived
assets and certain identifiable intangibles to be held and used by an entity are
reviewed by the management of the Company for impairment whenever events or
changes in circumstances indicate that the carrying value of an asset may not be
recoverable. As of June 30, 2007, management of the Company believes that no
impairment has been indicated. There can be no assurances, however, that market
conditions will not change or demand for the Company's products will continue
which could result in impairment on long-lived assets in the
future.
Revenue
Recognition
Revenue is
recognized when the sales amount is determined, shipment of goods to the
customer has occurred and collection is reasonably assured. Product is shipped
FOB origination.
Research
and Development
Research and
development are charged to operations as they are incurred. Legal
fees and other direct costs incurred in obtaining and protecting patents are
expensed as incurred. Research and development costs totaled $155,886 and
$111,608 during the fiscal years ended June 30, 2007 and 2006,
respectively.
Income
Taxes
The Company
accounts for income taxes in accordance with Statement of Financial Accounting
Standards ("SFAS") No. 109, "Accounting for Income Taxes." Deferred
tax assets and liabilities are recognized for future tax consequences
attributable to differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax bases. 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. A valuation allowance is provided for certain deferred
tax assets when it is more likely than not that such tax assets will not be
realized through future operations.
23
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE 1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basic and
Diluted Earnings (Loss) Per Common Share
Basic
earnings (loss) per common share is computed by dividing income (loss) available
to common stockholders by the weighted average number of common shares
outstanding during the period of computation. Diluted earnings (loss) per share
gives effect to all potential dilutive common shares outstanding during the
period of compensation. The computation of diluted earnings (loss) per share
does not assume conversion, exercise or contingent exercise of securities that
would have an antidilutive effect on earnings. As of June 30, 2007 and 2006, the
Company had no potentially dilutive securities that would effect the loss per
share if they were to be dilutive.
Comprehensive
Income (Loss)
Total
comprehensive income (loss) represents the net change in stockholders' equity
during a period from sources other than transactions with stockholders and as
such, includes net earnings (loss). For the Company, the components of other
comprehensive income (loss) are the changes in the cumulative foreign currency
translation adjustments and unrealized gains (losses) on marketable securities
and cash equivalents and are recorded as components of stockholders'
equity.
Segments
of an Enterprise and Related Information
The Company
adopted SFAS No. 131, "Disclosures about Segments of an Enterprise and Related
Information." SFAS No. 131 establishes standards for the way public companies
report information about segments of their business in their annual financial
statements and requires them to report selected segment information in their
quarterly reports issued to stockholders. It also requires entity-wide
disclosures about the products and services an entity provides, the material
countries in which it holds assets and reports revenues and its major customers,
if any. As of June 30, 2007, the Company has only one segment of enterprise
which is medical products manufacturing and sales.
Inventory
Inventory is
stated at the lower of cost (computed on a first-in, first-out basis) or market
value. At June 30, 2007 all inventory consists of finished
goods. Inventory is evaluated periodically by management for
potential impairment. During the years ended June 30, 2007 and 2006,
the Company recognized no impairment expense pertaining to inventory. As of June
30, 2007 inventory consisted of the following:
Raw
materials
|
|
$
|
-
|
|
Finished
goods
|
|
|
88,353
|
|
Work in
process
|
|
|
-
|
|
|
|
|
|
|
Total
|
|
$
|
88,353
|
|
Trade
Receivables
The Company
periodically reviews its trade receivables for potential collectability
issues. The Company has implemented the policy to charge-off trade
receivables older than 120 days outstanding as bad-debt expense. As
of June 30, 2007, the Company had an allowance for doubtful accounts of
$-0-.
24
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE 1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
New
Accounting Pronouncements
During the
year ended December 31, 2007, the Company adopted the following accounting
pronouncements:
SFAS No. 157,
Fair
Value Measurements
-
This Statement
does not require any new fair value measurements, but rather, it provides
enhanced guidance to other pronouncements that require or permit assets or
liabilities to be measured at fair value. However, the application of
this Statement may change how fair value is determined. The Statement
is effective for financial statements issued for fiscal years beginning after
November 15, 2007, and interim periods within those fiscal years. As
of December 1, 2007 the FASB has proposed a one-year deferral for the
implementation of the Statement for nonfinancial assets and nonfinancial
liabilities that are recognized or disclosed at fair value in the financial
statements on a nonrecurring basis. The implementation of this
pronouncement had no material effect on the Company’s financial
statements.
SFAS No. 158,
Employers’
Accounting for Defined Benefit Pension and Other Postretirement Plans – an
amendment of FASB Statements No. 87, 88, 106, and 132(R)
-
This Statement requires
that employers measure plan assets and obligations as of the balance sheet
date. This requirement is effective for fiscal years ending after
December 15, 2008. The other provisions of the Statement were
effective as of the end of the fiscal year ending after December 15, 2006, for
public companies. The implementation of this pronouncement had no
material effect on the Company’s financial statements.
SFAS No. 159,
The Fair
Value Option for Financial Assets and Financial Liabilities – Including an
amendment of FASB Statement No. 115
-
This Statement provides
all entities with an option to report selected financial assets and liabilities
at fair value. The Statement is effective as of the beginning of an
entity’s first fiscal year beginning after November 15, 2007, with early
adoption available in certain circumstances. The implementation of
this pronouncement had no material effect on the Company’s financial
statements.
SOP No. 07-01,
Clarification
of the Scope of the Audit and Accounting Guide “Investment Companies” and
Accounting by Parent Companies and Equity Method Investors for Investments in
Investment Companies
-
SOP 07-01 provides guidance for determining whether an entity is within
the scope of the AICPA Audit and Accounting Guide
Investment
Companies.
The provisions of the SOP are effective for fiscal
years beginning on or after December 15, 2007, with earlier application
encouraged. As of December 1, 2007 the FASB has proposed an
indefinite deferral of this SOP. The implementation of this
pronouncement had no effect on the Company’s financial statements.
EITF
Issue No. 06-1, Accounting for Consideration Given by a Service Provider to a
Manufacturer or Reseller of Equipment Necessary for an End-Customer to Receive
Service from the Service Provider
-
This consensus
concludes that if the consideration given by a service provider to a
manufacturer or reseller (that is not a customer of the service provider) can be
linked contractually to the benefit received by the service provider's customer,
the service provider should account for the consideration in accordance with
EITF Issue 01-9. The consensus is effective for the first annual
reporting period beginning after June 15, 2007. The implementation of
this pronouncement had no effect on the Company’s financial
statements.
25
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE 1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
New
Accounting Pronouncements (Continued)
EITF
Issue No. 06-4, Accounting for Deferred Compensation and Postretirement Benefit
Aspects of Endorsement Split-Dollar Life Insurance Arrangements
-
This consensus
concludes that for a split-dollar life insurance arrangement within the scope of
this Issue, an employer should recognize a liability for future benefits in
accordance with FASB Statement No. 106 (if, in substance, a postretirement
benefit plan exists) or APB Opinion No. 12 (if the arrangement is, in substance,
an individual deferred compensation contract) based on the substantive agreement
with the employee. The consensus is effective for fiscal years
beginning after December 15, 2007, with early application
permitted. The implementation of this pronouncement had no effect on
the Company’s financial statements.
EITF
Issue No. 06-8, Applicability of the Assessment of a Buyer's Continuing
Investment under FASB Statement No. 66, “Accounting for Sales of Real Estate”,
for Sales of Condominiums
-
This consensus
concludes that an entity is required to evaluate the adequacy of a buyer’s
initial and continuing investment for purposes of determining whether it is
appropriate to recognize profit from a real estate sale involving a condominium
unit or time-sharing interest under the percentage-of-completion method under
Statement No. 66. The consensus is effective for the first annual
reporting period beginning after March 15, 2007. The implementation
of this pronouncement had no effect on the Company’s financial
statements.
EITF
Issue No. 06-10, Accounting for Collateral Assignment Split-Dollar Life
Insurance Arrangements
-
In this Issue, a
consensus was reached that an employer should recognize a liability for the
postretirement benefit related to a collateral assignment split-dollar life
insurance arrangement in accordance with either FASB Statement No. 106 or APB
Opinion No. 12, as appropriate, if the employer has agreed to maintain a life
insurance policy during the employee's retirement or provide the employee with a
death benefit based on the substantive agreement with the employee. A
consensus also was reached that an employer should recognize and measure an
asset based on the nature and substance of the collateral assignment
split-dollar life insurance arrangement. The consensuses are
effective for fiscal years beginning after December 15, 2007, including interim
periods within those fiscal years, with early application
permitted. The implementation of this pronouncement had no effect on
the Company’s financial statements.
EITF
Issue No. 06-11, Accounting for Income Tax Benefits of Dividends on Share-Based
Payment Awards
-
In this Issue, a
consensus was reached that a realized income tax benefit from dividends or
dividend equivalents that are charged to retained earnings and are paid to
employees for equity-classified nonvested equity shares, nonvested equity share
units, and outstanding equity share options should be recognized as an increase
in additional paid-in capital. This Issue should be applied
prospectively to the income tax benefits that result from dividends on
equity-classified employee share-based payment awards that are declared in
fiscal years beginning after December 15, 2007, and interim periods within those
fiscal years. Early application is permitted. The
implementation of this pronouncement had no effect on the Company’s financial
statements.
26
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE 1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
New
Accounting Pronouncements (Continued)
EITF
Issue No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or
Services Received for Use in Future Research and Development
Activities
-
In this Issue, a
consensus was reached that
nonrefundable
advance
payments for future research and development activities should be deferred
and capitalized. This Issue is effective for financial
statements issued for fiscal years beginning after December 15, 2007, and
interim periods within those fiscal years. Early application is
not permitted. The implementation of this pronouncement had no
effect on the Company’s financial
statements.
|
FSP No.
FAS 158-1, Conforming Amendments to the Illustrations in FASB Statements No. 87,
No. 88, and No. 106 and to the Related Staff Implementation Guides
-
This FSP provides
conforming amendments to the illustrations in FASB Statements No. 87, 88, and
106 and to related staff implementation guides as a result of the issuance of
FASB Statement No. 158. The conforming amendments made by this FSP
are effective as of the effective dates of Statement No. 158. The
unaffected guidance that this FSP codifies into Statements No. 87, 88, and 106
does not contain new requirements and therefore does not require a separate
effective date or transition method. The implementation of this
pronouncement had no effect on the Company’s financial statements.
FSP No.
FIN 39-1, Amendment of FASB Interpretation No. 39
-
This FSP amends FASB
Interpretation (FIN) No. 39,
Offsetting of Amounts Related to
Certain Contracts,
to permit a reporting entity to offset fair value
amounts recognized for the right to reclaim cash collateral or the obligation to
return cash collateral against fair value amounts recognized for derivative
instruments executed with the same counterparty under the same master netting
arrangement that have been offset in accordance with paragraph 10 of FIN
39. The guidance in this FSP is effective for fiscal years beginning
after November 15, 2007, with early application permitted. The
implementation of this pronouncement had no effect on the Company’s financial
statements.
FSP No.
FIN 46(R)-7, Application of FASB Interpretation No. 46(R) to Investment
Companies
-
This FSP addresses the application of FASB Interpretation (FIN) No. 46
(revised December 2003),
Consolidation of Variable Interest
Entities
, by an entity that accounts for its investments in accordance
with the specialized accounting guidance in the AICPA Audit and Accounting
Guide,
Investment
Companies
. The provisions of the FSP are effective when the
entity adopts SOP 07-01. The implementation of this pronouncement had
no effect on the Company’s financial statements.
SEC
Staff Accounting Bulletin No. 109, Written Loan Commitments Recorded at Fair
Value Through Earnings
-
SAB 109
expresses the current view of the staff that the expected net future cash flows
related to the associated servicing of the loan should be included in the
measurement of all written loan commitments that are accounted for at fair value
through earnings. SEC registrants are expected to apply the
views in Question 1 of SAB 109 on a prospective basis to derivative loan
commitments issued or modified in fiscal quarters beginning after December 15,
2007. The implementation of this pronouncement had no effect on the
Company’s financial statements.
27
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE 1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Major
Customers
During the
years ended June 30, 2007 and 2006 the Company had three customers to whom sales
exceeded 10% of the Company’s total sales for the period. Each
customer is an unrelated third party. These three companies combined
to constitute approximately 70% of the Company’s gross revenues for the years
ended June 30, 2007 and 2006, respectively.
NOTE 2 - PROPERTY AND EQUIPMENT
Property
and equipment consists of the following at June 30, 2007:
Technical and
laboratory
equipment
|
|
$
|
645,214
|
|
Leasehold
improvements
|
|
|
388,855
|
|
Office
equipment
|
|
|
164,270
|
|
Office
furniture
|
|
|
26,962
|
|
Other
|
|
|
1,324
|
|
|
|
|
|
|
Total property
and equipment
|
|
|
1,226,625
|
|
|
|
|
|
|
Less accumulated
depreciation and amortization
|
|
|
(1,222,095
|
)
|
|
|
|
|
|
Total property
and equipment, net
|
|
$
|
4,530
|
|
NOTE 3 - STOCKHOLDERS' EQUITY
Common Stock
- The
Company is authorized to issue 50,000,000 shares of no par value common stock.
The holders of the Company's common stock are entitled to one vote for each
share held of record on all matters to be voted on by those
stockholders.
Preferred Stock
- The
Company is authorized to issue 5,000,000 shares of non-voting no par value
preferred stock. The Board of Directors has not designated any liquidation value
or dividend rates.
Stock Options
- From
time to time, the Company may issue stock options pursuant to various agreements
and other contemporary agreements. At June 30, 2007 and 2006, and
during the years ended June 30, 2007 and 2006, no options were issued or
outstanding.
Treasury Stock
- On
July 1, 2004, the Company purchased 100,000 shares of its common stock from an
investor for approximately $0.278 per share. The Company purchased an
additional 620,000 shares of its common stock on November 11, 2004 for
approximately $0.191 per share. During the course of the 2005 fiscal
year the Company sold a total of 288,000 of these treasury shares for total
proceeds of approximately $63,907, resulting in a loss of approximately $13,602,
which was applied to additional paid-in capital. During the 2006
fiscal year the remainder of these shares were sold, resulting in a loss of
approximately $28,022. As of June 30, 2007 the Company held zero
shares of treasury stock.
28
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE
4 - INCOME TAX PROVISION
No current
provision for income taxes for the years ended June 30, 2007 and 2006 is
required, since the Company incurred net operating losses through June 30,
2007.
Income tax
expense for the years ended June 30, 2007 and 2006 differed from the amounts
computed by applying the U.S. federal income tax rate of 34 percent as
follows:
|
|
2007
|
|
|
2006
|
|
Income tax
benefit at U.S. federal statutory rates
|
|
$
|
(281,409
|
)
|
|
$
|
(514,987
|
)
|
Net operating
losses not benefited
|
|
|
281,409
|
|
|
|
514,987
|
|
Common stock
issued for services
|
|
|
-
|
|
|
|
-
|
|
State and
local income taxes, net of federal income tax effect
|
|
|
-
|
|
|
|
-
|
|
|
|
$
|
-
|
|
|
$
|
-
|
|
The tax
effects of temporary differences that give rise to significant portions of the
deferred tax assets at June 30, 2007 are presented below:
Deferred tax assets:
|
|
|
|
Net operating losses
|
|
$
|
7,700,000
|
|
Less valuation allowance
|
|
|
(7,700,000
|
)
|
Net deferred tax assets
|
|
$
|
-
|
|
As of June
30, 2007, the Company had net operating loss carryforwards of approximately $7.7
million, $3.4 million and $10.2 available to offset future taxable federal,
state and foreign income, respectively. The federal and state carryforward
amounts expire in varying amounts between 2007 and 2025. The foreign net
operating loss carryforwards do not have an expiration period.
NOTE
5 - BASIC AND DILUTED LOSS PER COMMON SHARE
The following
is a reconciliation of the numerators and denominators of the basic and diluted
loss per common share computations for the years ended June 30, 2007 and
2006:
|
|
2007
|
|
|
2006
|
|
Numerator
for basic and diluted loss per common
share
– net
loss
|
|
$
|
(721,562
|
)
|
|
$
|
(731,486
|
)
|
Denominator
for basic and diluted loss per common
share
– weighted average shares
|
|
|
50,000,000
|
|
|
|
48,751,875
|
|
Basic and
diluted loss per common share
|
|
$
|
(0.02
|
)
|
|
$
|
(0.02
|
)
|
NOTE 6 -
RELATED PARTY TRANSACTIONS
The Company
has an agreement with Professor Barnikol, the Company's President and CEO,
pursuant to which he is entitled to 3% royalties of gross revenues earned with
any product based on his inventions. No royalties were paid or earned in fiscal
2007 and 2006.
29
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE
7 - COMMITMENTS AND CONTINGENCIES
Indemnities
and Guarantees
During the
normal course of business, the Company has made certain indemnities and
guarantees under which it may be required to make payments in relation to
certain transactions. These indemnities include certain agreements with the
Company's officers, under which the Company may be required to indemnify such
person for liabilities arising out of their employment relationship. The
duration of these indemnities and guarantees varies and, in certain cases, is
indefinite. The majority of these indemnities and guarantees do not provide for
any limitation of the maximum potential future payments the Company could be
obligated to make. Historically, the Company has not been obligated to make
significant payments for these obligations. The Company has recorded a reserve
for indemnities and guarantees of $-0- and $-0- as of June 30, 2007 and 2006,
respectively.
Other
On April 14,
2005 the Company entered into a distribution agreement with an unrelated third
party. According to the terms of the Agreement, the Company granted
exclusive marketing and distribution rights pertaining to the Company’s
Chitosan-based wound pads to the third party for a period of five
years.
NOTE 8 -
STOCK-BASED COMPENSATION
The Company
has applied the disclosure provisions of Statement of Financial Accounting
Standards No. 123(R), "
Share
Based Payment
,” for the years ended June 30, 2007 and 2006. Released on
December 16, 2004, SFAS No. 123(R) supersedes APB Opinion No. 25, “Accounting
for Stock Issued to Employees.” There were no common shares or stock options
issued or granted to employees during this reporting period.
On April 28,
2004, the company adopted the 2004 Employee Stock Incentive Plan (the Plan).
Under the terms of this plan the Board was authorized to issue up to 1,000,000
shares of common stock to certain eligible employees of the company or its
subsidiaries.
NOTE 9 -
NOTES PAYABLE
During the
year ended June 30, 2007 and 2006, the Company borrowed money from four separate
European Companies in order to supplement its ongoing operational cash
flow. The Company issued notes in exchange for cash pursuant to the
following terms. All notes are due and payable on the fifth
anniversary of its issuance at a rate of 5% simple interest. The
Company has the right to convert these notes, including all unpaid principal and
any interest thereon, into shares of the Company’s Common Stock at any time
prior to full repayment or the Due Date. The total amount borrowed under these
terms, through June 30, 2007 was $113,134.
Loan Agreement with FID
Esprit AG
On April 4,
2006, the Company entered into a loan agreement with FID Esprit AG.
Pursuant to the terms of the loan agreement, FID Esprit AG loaned the Company
approximately $ 48,264 with interest of six percent per annum. The Company
has the option of paying the loan and interest in cash or with shares of
SanguiBioTech AG common stock, its wholly-owned subsidiary, valued at 50% of the
average Hamburg OTC trading price over the four weeks prior to
repayment.
30
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes to
the Consolidated Financial Statements
June 30,
2007
NOTE 9 -
NOTES PAYABLE (Continued)
Loan Agreement with Feedback
AG
On June 9,
2006, the Company entered into a loan agreement with Feedback AG. Dr.
Christoph Ludz and Thomas Striepe are signatories for Feedback AG.
Pursuant to the terms of the loan agreement, Feedback AG loaned the Company
approximately $96,527 with interest of six percent per annum. The Company
has the option of paying the loan and interest in cash or with shares of
SanguiBioTech AG common stock, its wholly-owned subsidiary, valued at 50% of the
average Hamburg OTC trading price over the four weeks prior to
repayment.
Second Loan Agreement with
Feedback AG
On July 21,
2006, the Company entered into a loan agreement with Feedback AG. Dr.
Christoph Ludz and Thomas Striepe are signatories for Feedback AG.
Pursuant to the terms of the loan agreement, Feedback AG loaned the Company
approximately $18,100 for the purpose of preparing a shareholders meeting.
The interest on this loan is set at six percent per annum.
Additional
Loans
From July
2006 to January 2007 the Company borrowed money from four separate European
companies and their affiliates to supplement its ongoing operational cash
flow. The Company issued notes in exchange for cash pursuant to the
following terms: All notes are due and payable in the fifth
anniversary of issuance at a rate of 5% simple interest. The Company,
in its sole discretion, has the right to convert these notes, including all
unpaid principal and any interest thereon, into shares of the Company’s common
stock at the rate of approximately $0.11 per share at any time prior to full
repayment or on the Due Date.
Agreements with ERC Nano Med
S.A. de C.V
.
On October
13, 2006 the Company entered into a Distribution, Collaboration, and
Commercialization Agreement with ERC S.A. de C.V., a division of ERC Nano Med.
of Mexico (“ERC”). Under the terms of the Agreement, the Company is
granting exclusive distribution rights of its 1) hemospray, 2) wound cleaner
liquid gel, and 3) bloodadditiv to ERC. In return, ERC is to work
with various Mexican Health Authorities necessary to grant government approvals
necessary for the products to be sold and distributed in Mexico. All
costs for obtaining the necessary approvals in Mexico are to be born by
ERC.
On the same
date the Company entered into a separate agreement with ERC pertaining to the
Company’s chitosin wound pads under the same terms.
31
ITEM 8.
CHANGES IN AND
DISAGREEMENTS WITH ACCOUNTANTS ON AN ACCOUNTING AND FINANCIAL
DISCLOSURE
Subsequent to
the period covered by this report, on September 18, 2007, the Board of Directors
of the Company dismissed HJ & Associates, LLC (“HJ & Associates”) as the
Company's independent auditors.
HJ &
Associates audited report of the financial statements for the years ended June
30, 2005 and 2004, included language expressing substantial doubt as to the
Company's ability to continue as a going concern. The audit report
contained no other adverse opinion or disclaimer of opinion and was not
qualified or modified as to uncertainty, audit scope or accounting
principles. As such, in connection with these audits of the fiscal years
ended June 30, 2005 and 2004 and the subsequent interim period prior to such
dismissal, there were (1) no disagreements with HJ & Associates on any
matter of accounting principles or practices, financial statement disclosure, or
auditing scope or procedure, which disagreements, if not resolved to the
satisfaction of HJ & Associates, would have caused them to make reference
thereto in their reports on the financial statements for such periods to the
subject matter of the disagreement, and (2) there were no reportable events as
that term is defined in Item 304(a)(1)(iv) of Regulation S-B. The change in
independent accountants did not result from any dissatisfaction with the quality
of professional services rendered by HJ & Associates.
Subsequent to the
period covered by this report, on September 18, 2007, the Company engaged of the
accounting firm of Moore & Associates, Chartered ("Moore & Associates")
as its independent auditors, effective immediately. Moore & Associates
have been asked to audit the Company's financial statements for the years
ending June 30, 2006 and 2007. During the two most recent fiscal years and
the subsequent interim periods prior to the engagement of Moore &
Associates, the Company did not consult with Moore & Associates with regard
to: (i) the application of accounting principles to a specific completed or
contemplated transaction, or the type of audit opinion that might be rendered on
the Company's financial statements; and further, Moore & Associates have not
provided written or oral advice to the Compnay that was an important factor
considered by the Company in reaching a decision as to any accounting, auditing
or financial reporting issue; or (ii) any matter that was either the subject of
a disagreement or a reportable event (as described in Item 304(a)(1)(iv) of
Regulation S-B).
The decision
to change principal auditors and the engagement of the new principal auditor was
recommended and approved by the Company's Board of Directors.
ITEM
8A.
CONTROLS AND
PROCEDURES
(
a)
Evaluation of disclosure
controls and procedures
. Our principal executive officer and
principal financial officer have evaluated the effectiveness of our disclosure
controls and procedures (as defined in Rules 13a-14(c) and 15d-14(c) under the
Exchange Act), as of a date within 90 days of the filing date of this Annual
Report on Form 10-KSB. Based on such evaluation, they have concluded
that as of such date, our disclosure controls and procedures are ineffective and
represent a material weakness. Such controls are designed to ensure
that information required to be disclosed by us in reports that we file or
submit under the Securities Exchange Act of 1934 is recorded, processed,
summarized and reported within the time periods specified in applicable SEC
rules and forms and that such information is accumulated and communicated to our
management, including CEO, President and CFO, to allow timely decisions
regarding required disclosure.
(b)
Changes in internal
controls
. There were no significant changes in our internal
controls or in other factors that could significantly affect these controls
subsequent to the date of evaluation by our principal executive officer and
principal financial officer.
ITEM
8B.
OTHER
INFORMATION
Loan
Agreement with FID Esprit AG
On April 4, 2006, the
Company entered into a loan agreement with FID Esprit AG. Pursuant to
the terms of the loan agreement, FID Esprit AG loaned the Company $48,264 with
interest of six percent per annum. The Company has the option of
paying the loan and interest in cash or with shares of SanguiBioTech AG common
stock, its wholly-owned subsidiary, valued at 50% of the average Hamburg OTC
trading price over the four weeks prior to repayment.
Loan
Agreement with Feedback AG
On
June 9, 2006, the Company entered
into a loan agreement with Feedback
AG. Two of the Company's Directors are also signatories for Feedback
AG. Pursuant to the terms of the loan agreement, Feedback AG loaned
the Company $96,527 with interest of six percent per annum. The
Company has the option of paying the loan and interest in cash or with shares of
SanguiBioTech AG common stock, its wholly-owned subsidiary, valued at 50% of the
average Hamburg OTC trading price over the four weeks prior to
repayment.
32
Second
Loan Agreement with Feedback AG
On July 21, 2006, the
Company entered into a loan agreement with Feedback AG. Two of the
Company's Directors are also signatories for Feedback AG. Pursuant to
the terms of the loan agreement, Feedback AG loaned the Company approximately
$18,100 for the purpose of preparing a shareholders meeting. The
interest on this loan is set at six percent per annum. The Company is
to pay the loan and interest off utilizing its common stock following the
shareholders meeting, however, if a shareholders meeting has not been held as of
July 30, 2007, then the loan and interest are due and payable in
cash.
Agreements
with ERC Nano Med S.A. de C.V.
On October 13, 2006, the
Company entered into a Distribution, Collaboration, and Commercialization
Agreement with ERC S.A. de C.V., a division of ERC Nano Med. of Mexico
(“ERC”). Under the terms of the agreement the Company is granting the
exclusive distribution rights of its i) hemospray, ii) wound cleaner liquid gel,
iii) chitoskin wound pads and iv) bloodadditiv to ERC. In return ERC
is to work with the various Mexican Health Authorities necessary to grant
government approvals necessary for the products to be sold and distributed in
Mexico. All costs for obtaining the necessary approvals in Mexico are
to be born by ERC.
On
the same date the Company entered into a separate agreement with ERC pertaining
to the Company’s chitosin wound pads under the same terms.
Additional
Loans to the Company
During
the year ended June 30, 2007 and 2006, the Company borrowed money from four
separate European Companies in order to supplement its ongoing operational cash
flow. The Company issued notes in exchange for cash pursuant to the
following terms. All notes are due and payable on the fifth
anniversary of its issuance at a rate of 5% simple interest. The
Company has the right to convert these notes, including all unpaid principal and
any interest thereon, into shares of the Company’s Common Stock at any time
prior to full repayment or the Due Date. The total amount borrowed under these
terms, through June 30, 2007 was $113,134.
Resignation
of Dr. Wolfgang Barnikol from positions of Chief Executive Officer and Chief
Financial Officer
Subsequent
to the period covered by this report, on March 30, 2008, Dr. Wolfgang Barnikol
amicably resigned as the Company’s Chief Executive Officer and Chief Financial
Officer effective April 3, 2008. Dr. Barnikol's resignation was not due to
any disagreement with the Company. Dr. Barnikol remains a
Director.
Appointment
of Thomas Striepe as Chief Executive Officer
Subsequent
to the period covered by this report, on April 8, 2008, the Board of Directors
appointed Thomas Striepe to serve as Chief Executive Officer of the
Company. He is a current Director of the Company. Mr. Striepe is the
Vice President of Accounting and Controlling at Feedback AG, Hamburg, Germany, a
financial services company. Prior to joining in 2004, he held management
positions in the accounting departments of several German and international
corporations. He holds an MBA from Hamburg University. Mr. Striepe
does not have an employment agreement with the Company nor have the terms of a
severance agreement with the Company been finalized.
Mr.
Striepe has no family relationships with any other director or executive officer
of the Company or any person nominated to become a director or executive officer
of the Company. There are no arrangements or understandings between any of
the directors or executive officers, or any other person or person pursuant to
which they were selected as directors and/or
officers.
Appointment
of Joachim Fleing as Chief Financial Officer
Subsequent
to the period covered by this report, on April 8, 2008, the Board of Directors
appointed Joachim Fleing to serve as Chief Financial Officer of the
Company. He is a current Director of the Company. Mr. Fleing is a
communications specialist. His professional experience includes the
position of a communications officer and the position as an account director at
an international PR agency. Mr. Fleing holds a PhD from Wuppertal
University. Mr. Fleing does not have an employment agreement with the
Company, nor have the terms of any severance agreement with the Company been
finalized and are thus not yet available.
Mr.
Fleing has no family relationships with any other director or executive officer
of the Company or any person nominated to become a director or executive officer
of the Company. There are no arrangements or understandings between any of
the directors or executive officers, or any other person or person pursuant to
which they were selected as directors and/or
officers.
Entry
into Letter of Intent with HemCon
Subsequent
to the period covered by this report, on April 15, 2008 the Company signed a
letter of intent with HemCon Medical Techolologies, Inc. to develop technology
relating to Chitosan wound care products. The Company will license exclusive
worldwide sales and marketing rights in exchange for HemCon managing the
submission of the Chitosan wound care products to the United States Food and
Drug Administration.
Sale
of Capital Securities in Wholly Owned Subsidiary
Subsequent
to the period covered by this report, on April 25, 2008 the Company entered into
letters of intent with various European investors to sell 10% of the capital
securities of its wholly owned subsidiary, Sangui BioTech GmbH, for
approximately 722,000 Euros. Payments for the purchase were received in their
entirety by the Company by May 16, 2008. The closing of this transaction is
subject to German Law and is anticipated to be complete within eight weeks of
filing with the German Register of Commercial Companies scheduled for June 11,
2008 in Witten Germany.
One
of the investors in this transaction is the current Managing Director of the
wholly owned subsidiary; he is receiving his ownership interest in consideration
of past services rendered for the Company in the amount of 50,000
Euros.
Resignation
of Director
Subsequent
to the period covered by this report, on September 30, 2008, Prof. Dr. Dr.
Wolfgang Barnikol submitted his resignation as a Director of the Board of
Directors of the Registrant, effective as of September 30, 2008. There were no
disagreements between the Registrant and Dr. Barnikol that led to his
resignation.
33
PART
III
ITEM 9.
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS COMPLIANCE WITH SECTION 16(a)
OF THE EXCHANGE ACT.
The
following table sets forth the names and ages of the current directors and
executive officers of Sangui BioTech International, Inc., their principal
offices and positions and the date each such person became a director or
executive officer. Our executive officers are elected annually by the
Board of Directors. Our directors serve one-year terms until their
successors are elected. The executive officers serve terms of one
year or until their death, resignation or removal by the Board of
Directors. There are no family relationships between any of the
directors and executive officers. In addition, there was no
arrangement or understanding between any executive officer and any other person
pursuant to which any person was selected as an executive officer.
The
directors as of June 30, 2007 were as follows:
Name
|
|
Age
|
|
Positions and
Offices
|
Directorship
Term
|
Period of Service as a
Director
|
|
|
|
|
|
|
|
Prof.
Wolfgang Barnikol, M.D., Ph.D:
|
|
72
|
|
Chief
Executive Officer, Chief Financial Officer, and Director*
|
One
Year
|
Apr
18, 2001
|
|
|
|
|
|
|
|
Joachim
Fleing, Ph.D.
|
|
54
|
|
Non-Executive
Director
|
One
Year
|
Dec
13, 2003
|
|
|
|
|
|
|
|
Prof.
Joachim Lutz, M.D., Ph.D.
|
|
73
|
|
Non-Executive
Director
|
One
Year
|
Aug,
1997
|
|
|
|
|
|
|
|
Thomas
Striepe
|
|
43
|
|
Non-Executive
Director
|
One
Year
|
Feb
7, 2005
|
|
|
|
|
|
|
|
*Subsequent to the
period covered by this report, Prof Barnikol resigned from his Executive Officer
and Director positions. See Item 8B, Other
Information above.
None
of the Directors are related to one another. None of the independent
Directors has a business or professional relationship with SGBI and/or the other
Directors and substantial shareholders of SGBI, except as
follows:
The
Company has an agreement with Professor Barnikol, the Company’s President and
CEO, pursuant to which he is entitled to 3% royalties of gross revenues earned
with any product based on his inventions (See below: Item 12 Certain
Relationships and Related Transactions). No royalties were paid or
earned in fiscal 2007 and 2006.
Since
July, 2002, the Company has an agreement with Joachim Fleing under which the
latter serves as a communications specialist on an hourly
basis.
The
day-to-day operations of SGBI are entrusted to the Executive Directors of
SGBI.
The
business and working experience of the Directors and key Executive Officers of
SGBI as of June 30, 2007, are set out below:
PROFESSOR
WOLFGANG K. R. BARNIKOL, M.D., Ph.D., has studied chemistry, physics and
medicine at the Universities of Munster, Aachen and Mainz, Germany. In 1961, he
received a Diploma in chemistry from University of Mainz, Mainz, Germany. In
1964, he obtained the doctorate in physical chemistry (Dr. rer. nat.) and in
1973 the doctorate in medicine (Dr. med.) both from the University of Mainz,
Mainz, Germany. In that same year, he also was appointed professor in medical
physiology at University of Mainz, Mainz Germany. In 1996, Dr. Barnikol was
awarded a specialist in medical physiology by the medical association of
Rheinland-Pfalz Germany. His research interest in physical chemistry focused on
the polymerization of styrene and the determination of molecular weights of
polymers with the electron microscope. Dr. Barnikol's research areas in medicine
are: (i) respiration; and (ii) blood and circulation. In the field of
respiration, he works on the functional analysis of the bronchial system and gas
exchange. Moreover, he is engaged in the development of respiratory and skin
oxygen sensors. In the field of blood and circulation, he works on the
development of artificial oxygen carriers for medical use, which are based on
polymerised soluble hemoglobins. As a third sphere of work, Dr. Barnikol is
engaged in the development of an implantable glucose sensor. Dr. Barnikol has
published more than 100 scientific articles, a textbook in physiology and a
review on the situation of German universities.
PROFESSOR
JOACHIM LUTZ, M.D., is a professor and lecturer in medical physiology in the
subject area of the vascular system and venous pressure at the Physiological
Institute of the Bavarian-Julius-Maximilian University in Wuerzburg until his
retirement in 1998. There he spent years evaluating artificial oxygen carriers
in small animal models such as the magneto metric determination of the
impairment of the body's own macrophages that are responsible for
detoxification. He is a member of the International Advisory Committee on Blood
Substitutes (ISABI) as well as the International Society on Oxygen Transport to
Tissue (ISOTT). He will accelerate development work as well as the pre-clinical
and clinical testing of blood with artificial oxygen carriers with his technical
knowledge and experience.
THOMAS
STRIEPE, is Vice President Accounting and Controlling at Dr. Ludz GmbH, Hamburg,
Germany, a financial services company. Prior to joining Dr. Ludz GmbH in 2004,
he held management positions in the accounting departments of several German and
international corporations. He holds an MBA of Hamburg University.
JOACHIM
FLEING, PhD, is a communications specialist. His professional experience
includes the position of a communications officer and the position as an account
director at an international PR agency. Joachim Fleing holds a PhD of Wuppertal
University.
There are
no arrangements or understandings between any of the directors or executive
officers, or any other person or person pursuant to which they were selected as
directors and/or officers.
Significant
Employees
HUBERTUS
SCHMELZ is the General Manager of Sangui GmbH. He was appointed to this position
effective December 16, 2003. Prior to joining Sangui he acted as legal and
business consultant. During the last decade prior to 2000 he was entrusted with
numerous business development projects by the German Treuhandanstalt in
restructuring the economy of Eastern Germany. After having studied the Law he
acted as Legal Counsel in several positions.
Directorships
No
Director of the Company or person nominated or chosen to become a Director holds
any other directorship in any company with a class of securities registered
pursuant to section 12 of the Exchange Act or subject to the requirements of
section 15(d) of such Act or any other company registered as an investment
company under the Investment Company Act of 1940.
Family
Relationships
There are no family
relationships between any of the directors, officers or employees of the
Company.
Involvement
in Certain Legal Proceedings
Subsequent
to the period covered by this report, on September 13, 2007, the District Appeal
Court of Dusseldorf, Germany (Oberlandesgericht Düsseldorf I 6 U 96/06) found
Prof. Dr. Dr. Wolfgang Barnikol jointly and severally liable in a civil suit to
Dr. Rainer Felfe, a shareholder of the Company, in the amount of approximately
700,000 euros (approximately US $952,000, which amount includes interest and
costs) for supporting the unethical selling of the Company's shares. This
judgment is enforceable, but has not yet become final and absolute as Dr.
Barnikol has submitted a petition of appeal to the Federal Supreme Court of
Germany (Bundesgerichtshof). The Company was not and is not a party to these
proceedings. Additionally,
on
September 2, 2008, the District Court of Dusseldorf (Landgericht Düsseldorf 7 O
299/04) found Prof. Dr. Dr. Wolfgang Barnikol jointly and severally liable in a
civil suit to a shareholder of the Company in the amount of approximately
150,000 euros (approximately US $204,000, which amount includes interest and
costs) for supporting the unethical selling of the Company's shares. This
judgment is enforceable, but has not yet become final and absolute. The Company
was not and is not a party to these proceedings. On
September
30, 2008, Prof. Dr. Dr. Wolfgang Barnikol submitted his resignation as a
Director of the Board of Directors, effective as of September 30, 2008 and on
March 30, 2008, Dr. Wolfgang Barnikol amicably resigned as the Company’s
Chief Executive Officer and Chief Financial Officer effective April 3,
2008. Dr. Barnikol's resignations were not due to any disagreement with
the Company.
Except
as set forth above, during the past five years, no present or former director,
executive officer or person nominated to become a director or an executive
officer of the Company:
(1) was
a general partner or executive officer of any business against which any
bankruptcy petition was filed, either at the time of the bankruptcy or two years
prior to that time;
(2) was
convicted in a criminal proceeding or named subject to a pending criminal
proceeding (excluding traffic violations and other minor offenses);
(3) was
subject to any order, judgment or decree, not subsequently reversed, suspended
or vacated, of any court of competent jurisdiction, permanently or temporarily
enjoining, barring, suspending or otherwise limiting his involvement in any type
of business, securities or banking activities; or
(4) was
found by a court of competent jurisdiction (in a civil action), the Securities
and Exchange Commission or the Commodity Futures Trading Commission to have
violated a Federal or state securities or commodities law, and the judgment has
not been reversed, suspended or vacated.
Audit
Committee and Audit Committee Financial Expert
The
Company has no separately designated standing audit committee nor another
committee performing similar functions. The Board of Directors acts
as the audit committee. None of the directors qualifies as an Audit
Committee Financial Expert.
Material
Changes to The Method By Which The Shareholders May Recommend Nominees To The
Board Of Directors
None.
Section 16 (a) Beneficial Ownership
Compliance
Section
16(a) of the Securities Exchange Act of 1934 requires the Company's executive
officers, directors and persons who own more than ten percent of the Company's
Common Stock, to file initial reports of beneficial ownership on Form 3, changes
in beneficial ownership on Form 4 and an annual statement of beneficial
ownership on Form 5, with the SEC. Such executive officers, directors
and greater than ten percent shareholders are required by SEC rules to furnish
the Company with copies of all such forms that they have filed.
Based
solely upon a review of copies of the reports filed, SGBI believes that during
the year ended June 30, 2007, that all executive officers, directors and persons
who own more than ten percent of the Company's Common Stock are in compliance
with such regulations.
Code of Ethics
The
Company has not as of the date of this report adopted a code of
ethics.
ITEM
10.
EXECUTIVE
COMPENSATION AND OTHER INFORMATION
Summary Compensation
Table
The
table below summarizes all compensation awarded to, earned by, or paid to our
Officers for all services rendered in all capacities to us for the fiscal
periods indicated.
Name
and
Principal
Position
(a)
|
Year
(b)
|
Salary
($)(1)
(c)
|
Bonus
($)
(d)
|
Stock
Awards
($)
(e)
|
Option
Awards
($)
(f)
|
Non-Equity Incentive Plan
Compensation
($)
(g)
|
Nonqualified Deferred
Compensation Earnings
($)
(h)
|
All Other
Compensation
($)
(i)
|
Total
(1)
($)
(j)
|
Prof.
Wolfgang Barnikol
CEO,
CFO*
|
2007
2006
2005
|
0
0
38,134
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
38,134
|
*
Subsequent to the period covered by this report, Prof Barnikol resigned from his
Executive Officer and Director positions. See Item 8B, Other
Information above.
(1)
|
All
figures are expressed in United States Dollars (“USD”); for the German
management personnel, the EURO or DM was converted to USD as of the fiscal
year end of each year.
|
Narrative
Disclosure to Summary Compensation Table
The Company has an
agreement with Professor Barnikol, the Company’s CEO and CFO, pursuant to which
he is entitled to 3% royalties of gross revenues earned with any product based
on his inventions (See below: Item 12 Certain Relationships and Related
Transactions). No royalties were paid or earned in fiscal 2007 and
2006.
There are no other
employment contracts, compensatory plans or arrangements, including payments to
be received from the Company with respect to any executive officer, that would
result in payments to such person because of his or her resignation, retirement
or other termination of employment with the Company, or its subsidiaries, any
change in control, or a change in the person’s responsibilities following a
change in control of the Company.
There are no agreements or
understandings for any executive officer to resign at the request of another
person. None of our executive officers acts or will act on behalf of or at the
direction of any other person.
36
Outstanding Equity Awards at Fiscal
Year-End Table and Narative
The Company had no outstanding equity
awards at fiscal year-end.
Compensation of
Directors
The table below summarizes all
compensation awarded to, earned by, or paid to our Directors for all services
rendered in all capacities to us for the fiscal periods indicated.
Name
(a)
|
Fees Earned or Paid in
Cash
(b)
|
Stock
Awards
($)
(c)
|
Option
Awards
($)
(d)
|
Non-Equity Incentive Plan
Compensation
($)
(e)
|
Nonqualified Deferred
Compensation Earnings
($)
(f)
|
All Other
Compensation
($)
(g)
|
Total
($)
(j)
|
Prof.
Wolfgang Barnikol
|
2007
2006
2005
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
Joachim
Lutz
|
2007
2006
2005
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
Thomas
Striepe
|
2007
2006
2005
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
Joachim
Fleing
|
2007
2006
2005
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
Narrative to Director Compensation
Table
Directors serve without compensation
and there are no standard or other arrangements for their
compensation. There are no employment contracts, compensatory plans
or arrangements, including payments to be received from the Company with respect
to any Director that would result in payments to such person because of his or
her resignation with the Company, or its subsidiaries, in the event of any
change in control of the Company. There are no agreements or
understandings for any Director to resign at the request of another
person. None of our Directors or executive officers acts or will act
on behalf of or at the direction of any other person.
Other Contracts
None.
37
ITEM
11.
SECURITY OWNERSHIP OF
CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
Securities Authorized for Issuance
under Equity Compensation Plans
No securities
have been authorized for issuance as part of any Equity Compensation
Plan.
Stock Incentive
Plan
On April
28, 2004, the company adopted the 2004 Employee Stock Incentive Plan. Under the
terms of this plan the Board was authorized to issue up to 1,000,000 shares of
common stock to certain eligible employees of the company or its
subsidiaries. As of the date of this Report no securities have been
authorized for issuance under this plan.
Security Ownership of Certain
Beneficial Owners
As of June 30, 2007 the Company is not
aware of any person who is the beneficial owner of more than 5% of the
issued and outstanding Common Stock of the Company.
Security Ownership of
Management
The following table sets forth, as of
June 30, 2007, certain information concerning ownership of shares of Common
Stock by each director of the Company and by all executive officers and
directors of the Company as a group:
Title
of Class
|
Name
and Address
of
Beneficial Owner
|
Amount
and Nature of Beneficial Ownership
|
Percent
of Class
|
Common
Stock
|
Dr.
Wolfgang Barnikol
Arndstr.8
58453
Witten
Germany
|
1,853,600
(1)
|
3.7
%
|
Common
Stock
|
Dr.
Joachim Fleing
Am
Vogelherd 43
35043
Marburg
Germany
|
210,000
|
0.4
%
|
Common
Stock
|
Joachim
Lutz
Alfred
Herrhausen Street 44
58455
Witten
Germany
|
0
|
0.0%
|
Common
Stock
|
Thomas
Striepe
Alfred
Herrhausen Street 44
58455
Witten
Germany
|
0
|
0.0%
|
Common
Stock
|
All
Officers and Directors as a Group (4 persons)
|
2,063,600
|
4.1%
|
(1)
This
amount includes 1,153,600 shares held in the name of Dr. Doris Barnikol-Keuten,
Dr. Wolfgang Barnikol’s spouse.
38
Changes
In Control
To the
best of the Company’s knowledge there are no present arrangements or pledges of
the Company's securities, which may result in a change in control of the
Company.
ITEM
12.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Transactions
with related persons
Except as
otherwise disclosed below, no Director, substantial shareholder or Executive
Officer of SGBI was or is an interested party in any transaction undertaken by
SGBI or its subsidiaries within the last two years.
Royalty
Arrangment With Professor Wolfgang Barnikol
On July 7, 1997, SGBI
entered into an agreement with Professor Barnikol pursuant to which Professor
Barnikol assigned certain patents to SGBI's German subsidiaries in exchange for
a 3% royalty on net revenues on products developed by SanguiBioTech AG or
GlukoMeditech AG based on those patents. The royalty expires in 20
years or upon expiration of the patents. Upon the merger of the two
former subsidiaries and subsequently upon their conversion into SanguiBioTech
GmbH, this agreement was transferred to the respective new legal
entities.
Consulting Contract
With Joachim Fleing, PhD.
The company signed a
consulting contract with Joachim Fleing, PhD, covering certain investor
relations services on July 17, 2002. When the latter was appointed a director of
the company effective December 16, 2003, the Board of Directors unanimously
agreed that this contract should persist. Under this resolution Joachim Fleing,
like the other directors will not obtain any remuneration for serving as a
director, while those services as rendered under the contract should be
remunerated as before.
Parents
Not
applicable.
Promoters
and Control Persons
Not
applicable.
39
ITEM
13.
EXHIBITS
(a) Index
to Exhibits
2.1
|
Exchange Agreement
between MRC Legal Services LLC and SanguiBioTech International, Inc.,
dated of March 31, 2000 (1)
|
3.1
|
Articles of
Incorporation of the Company (1)
|
3.2
|
Bylaws of the
Company (1)
|
4.1
|
Stock Option
Agreement between Professor Wolfgang Barnikol and Sangui Biotech
International, Inc. (2)
|
10.1
|
Office Lease between
Brookhollow Office Park and Sangui Biotech International, Inc. dated
September 4, 1996 and as amended 2000 (3)
|
10.2
|
Fee Agreement
between GlukoMeditech AG and Dr. Sieglinde Borchert dated June 15,
1998 (2)
|
10.3
|
Fee Agreement
between SanguiBiotech AG and Dr. Sieglinde Borchert dated June 15,
1998 (2)
|
10.4
|
Service Contract
between GlukoMeditech AG and Dr. Wolfgang Barnikol dated June 30,
1998 (2)
|
10.5
|
Service Contract
between SanguiBiotech AG and Dr. Wolfgang Barnikol dated June 30,
1998 (2)
|
10.6
|
Service Agreement
between Axel Kleinkorres Promotionsagentur and Sangui Biotech
International, Inc. dated April 26, 1999 (2)
|
10.7
|
Amendment to Service
Agreement between Axel Kleinkorres Promotionsagentur and Sangui Biotech
International, Inc. dated August 18, 2000 (2)
|
10.8
|
Appropriation Notice
from North-Rhine-Westphalia to GlukoMediTech AG dated November 30,
1998 (2)
|
10.9
|
Appropriation Notice
from North-Rhine-Westphalia SanguiBiotech AG dated November 30,
1998 (2)
|
10.10
|
Lease Contract for
Business Rooms between Research and Development Centre, Witten, Germany
and GlukoMeditech AG dated June 6, 2000 (2)
|
10.11
|
Additional Agreement
to Lease Contract between Research and Development Centre, Witten, Germany
and GlukoMeditech AG dated June 7, 2000 (2)
|
10.12
|
Additional Agreement
to Lease Contract between Research and Development Centre, Witten, Germany
and SanguiBiotech AG dated June 7, 2000 (2)
|
10.13
|
Assignment of
Patents
and
Royalty Agreement with Dr. Wolfgang Barnikol
(3)
|
10.14
|
Prolongation Letter
for SanguiBiotech AG Grants (4)
|
16.1
|
Auditor Letter from
HJ & Associates, LLC (5)
|
21.1
|
Subsidiaries of the
Company (6)
|
31.01
|
Certification of CEO
Pursuant to Rule 13a-14(a) and 15d-14(a), filed herewith
|
31.02
|
Certification of
CFO Pursuant to Rule 13a-14(a) and 15d-14(a), filed
herewith
|
32.01
|
Certification
Pursuant to Section 1350 of Title 18 of the United States Code, filed
herewith
|
_____________________________________________________________________________________________________________________
(1) Filed as an
exhibit to the report on Form 8-K, filed on or about April 4, 2000
(2)
Filed as an exhibit to the report on Form 10-KSB for period ended
June 30,
2000,
filed on
October 13, 2000
(3)
Filed as
an exhibit to the amended report on Form 10-KSB/A for the period ended June 30,
2000, filed on November 20,
2000
(4)
Filed as an exhibit to the report on Form 10-KSB for the period ended June
30, 2001, filed o
n
September 28,
2001
(5)
Filed as an exhibit to the report on Form 8-K/A filed on October 9,
2007
(6)
Filed as an exhibit to the report on Form 10-QSB for the period ended September
30, 2006, filed on June 10, 2008
40
ITEM
14.
Principal
Accountant Fees and Services.
Independent
Public Accountants
The
Company’s independent accountants for the fiscal year ended June 30, 2007 and
June 30, 2006 were Moore & Associates, Chartered.
(a)
Audit
Fees
. For the fiscal year ended 2007, the aggregate fees
billed by Moore & Associates, Chartered for services rendered for the audits
of the annual financial statements and the review of the financial statements
included in the quarterly reports on Form 10-QSB or services provided in
connection with the statutory and regulatory filings or engagements for those
fiscal years were $10,000.
(b)
Audit-Related
Fees
. For the fiscal year ended 2007 fees billed by Moore
& Associates, Chartered , were an aggregate $0 for any audit-related
services other than as set forth in paragraph (a) above.
(c)
Tax
Fees
. For the fiscal years ended 2007 and 2006, Moore &
Associates, Chartered did not bill any fees for tax compliance
services. The auditors did not provide tax-planning advice for the
fiscal years ended 2007 and 2006.
(d)
All
Other Fees
. None.
41
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Company has duly
caused this report on Form 10-KSB/A to be signed on its behalf by the
undersigned hereunto duly authorized.
SANGUI
BIOTECH INTERNATIONAL, INC.
/s/
Thomas Striepe
Thomas
Striepe
Chief
Executive Officer and Director
|
October
15, 2008
|
/s/
Joachim Fleing
Joachim
Fleing, Ph.D
Chief
Financial Officer and Director
|
October
15, 2008
|
In
accordance with the Exchange Act, this Report has been signed by the following
persons on behalf of the Company and in the capacities and on the dates
indicated.
Signatures
|
Title
|
Date
|
/s/
Thomas Striepe
Thomas
Striepe
|
Chief
Executive Officer and Director
|
October
15, 2008
|
/s/
Joachim Fleing
Joachim
Fleing, Ph.D
|
Chief
Financial Officer and Director
|
|
/s/
Joachim
Lutz
Joachim
Lutz, M.D.
|
Director
|
|
42
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