form10ksb.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
_______________________
FORM
10-KSB
ANNUAL
REPORT UNDER SECTION 13 OR 15 (d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended: June 30,
2005
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
(I.R.S.
Employer
Incorporation or
Organization) Identification
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, 2005, were
approximately $
45,200.
The
aggregate market value of the voting and non-voting common equity held by
non-affiliates of the Registrant on May 29, 2007 based upon the average bid
and
ask price of the common stock on the pinksheets.com market segment for such
date, was approximately $ 30,750,000.
The
number of shares of the Registrant's common stock issued and outstanding on
May
29, 2007, was 50,000,000.
Transitional
Small Business Disclosure Format. Yes o No
x
Table
of Contents
PART
I
|
|
Page
|
|
|
|
ITEM
1
|
Description
of Business
|
1
|
ITEM
2
|
Description
of Property
|
14
|
ITEM
3
|
Legal
Proceedings
|
14
|
ITEM
4
|
Submission
of Matters to a Vote of Security Holders
|
15
|
|
|
|
PART
II
|
|
|
|
|
|
ITEM
5
|
Market
for Common Equity, Related Stockholder Matters and Small Business
Issuer
Purchases of Equity Securities
|
15
|
ITEM
6
|
Management’s
Discussion and Analysis or Plan of Operation
|
16
|
ITEM
7
|
Financial
Statements
|
19
|
|
Independent
Auditors’ Report
|
20
|
|
Consolidated
Balance Sheet
|
21
|
|
Consolidated
Statements of Operations
|
23
|
|
Consolidated
Statements of Stockholders’ Equity
|
24
|
|
Consolidated
Statements of Cash Flows
|
25
|
|
Notes
to Consolidated Financial Statements
|
27
|
ITEM
8
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
38
|
ITEM
8 A
|
Controls
and Procedures
|
38
|
ITEM
8 B
|
Other
Information
|
38
|
|
|
|
PART
III
|
|
|
|
|
|
ITEM
9
|
Directors,
Executive Officers, Promoters and Control Persons; Compliance with
Section
16(a) of the Exchange Act
|
40
|
ITEM
10
|
Executive
Compensation
|
43
|
ITEM
11
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholders Matters
|
45
|
ITEM
12
|
Certain
Relationships and Related Transactions
|
46
|
ITEM
13
|
Exhibits
|
47
|
ITEM
14
|
Principal
Accountant Fees and Services
|
48
|
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.
1
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, 2005, SGBI's accumulated deficit has exceeded $21.1 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.
2
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,
subsequent to the period covered by this report, 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 medical faculty of Monterrey University and 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. The
authorization process will be managed in cooperation with Medicoforum group
of
Hannover, Germany, a company specializing in international pharmaceutical and
medical product authorizations.
According
to regulatory requirements, all drugs must complete preclinical and clinical
trials before approval (e.g. Federal Drug Administration 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 subsequent to the period covered by this report
in September of 2006.
Sales
of
the anti-cellulite products began in the period subsequent to this report in
August of 2005 via two German TV shop programs. Sales figures in
this distribution channel are stable, according to information provided by
our
distribution partner. Additionally, distribution partners in
Argentina and Mexico have purchased launch quantities in November of 2005,
and
July of 2006, respectively.
3
CHITOSKIN
WOUND PADS
In
March
2005, subsequent to the period covered by this report, 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 will deliver 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, and is accrued as accounts receivable at June 30,
2005.
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, 2005, Sangui
GmbH had been granted 18 patents. Furthermore, its subsidiary has
applied for 24 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. Four (4) 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)
|
4
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
|
|
5
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)
|
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 $426,831 and
$886,962 during the fiscal years ended June 30, 2005 and 2004,
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, 2005, 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 to constitute approximately 88% of the Company’s gross
revenues for the year ended June 30, 2005.
6
HUMAN
RESOURCES
The
Company considers its relations with its employees to be
favorable. As of June 30, 2005 SGBI and its subsidiaries had 2
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.
CERTAIN
BUSINESS RISKS
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.
7
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, 2005, 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.
8
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.
9
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.
10
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.
11
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.
12
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.
13
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 $56,525 and $66,966 during the years ended June 30, 2005 and
2004,
respectively.
ITEM
3. LEGAL PROCEEDINGS
On
August 4, 2003, SanguiBioTech AG
filed a lawsuit against a former director of SGBI, claiming that some payments
incurred by the defendant were unjustified under German law, Landgericht Munich
I Court, Case No. 34 O 14027/03). The defendant denied that the claim
is justified and brought forward the opinion that he could claim additional
fees. On February 10, 2005, the lawsuit was settled by order of the
Court. All claims and counterclaims between the parties were
irrevocably dismissed.
On
November 27, 2003, the company was served with a lawsuit, Landgericht Bochum
Court, Case No. 6 O 435/03. The lawsuit named, among others,
SanguiBioTech AG as defendant. The plaintiff alleged that the
Company, had neglected its duty in dealing with some of the plaintiff’s Sangui
BioTech International, Inc. shares. A judgement was handed down on
July 28, 2004 whereby the plaintiff’s action was been dismissed. No
appeal has been lodged. The Company recognized no financial impact
from this litigation.
14
On
June 15, 2005, SanguiBioTech GmbH
was served with a lawsuit, Amtsgericht Witten, Case No. 2 C
429/05. The plaintiff is a supplier of packaging foils for certain
medical products. The plaintiff claims payment of invoices
amounting to approximately $ 8,500. The Company had rejected the
delivery of the goods covered by the invoices due to poor
quality. The claim was settled subsequent to the period of this
report by order of the Court on September 7, 2005, whereby Sangui agreed to
pay
a lesser amount of approximately $6,406, including court fees.
The
Company is not aware of pending claims or assessments, other than as described
above, which may have a material adverse impact on the Company’s financial
position or results of operations.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No
matter
was submitted to our security holders for approval during the period covered
by
this Report.
PART
II
ITEM
5. MARKET FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND SMALL BUSINESS
ISSUER PURCHASES OF EQUITY SECURITIES
As
of
June 30, 2005, SGBI's common stock was traded on www.pinksheets.com under
the symbol SGBI as well as on the OTC market of the Hamburg stock exchange
in
Germany.
The
following table sets forth the high and low closing prices for shares of SGBI
common stock for the fiscal periods noted, as reported by
www.pinksheets.com. Quotations reflect inter-dealer prices,
without retail mark-up, markdown or commissions and may not represent actual
transactions.
|
|
CLOSING PRICES
(US$)
|
FISCAL
YEAR
|
PERIOD
|
HIGH
|
LOW
|
|
|
|
|
2004
|
July
- September
|
0.30
|
0.08
|
|
October
- December
|
0.13
|
0.10
|
|
January
- March
|
0.38
|
0.22
|
|
April
– June
|
0.33
|
0.17
|
2005
|
July
- September
|
0.27
|
0.07
|
|
October
- December
|
0.23
|
0.05
|
|
January
- March
|
0.27
|
0.11
|
|
April
– June
|
0.22
|
0.12
|
|
|
|
|
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, 2005, the number of record holders of the Company's common stock was
approximately 888. 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
In
January and February, 2005, the
company sold 3,500,000 shares of common stock to four German investors yielding
positive cash inflow of $187,500. 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.
15
In
February 2005, the Company issued
200,000 shares of common stock for prepaid consulting services valued at
$17,500. 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.
Subsequent
Events
In
August, 2005, the company sold
1,148,386 shares of common stock to a German investor yielding a cash
contribution in the amount of $100,484. 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.
In
January, 2006, the company sold
1,495,960 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, 2005. 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 $426,831 and
$886,962 during the fiscal years ended June 30, 2005 and 2004,
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
January 2003, the FASB issued Interpretation Number 46, “Consolidation of
Variable Interest Entities” (“FIN No. 46”). This Interpretation of
Accounting Research Bulletin (“ARB”) No. 51, “Consolidated Financial
Statements,” provides guidance for identifying a controlling interest in a
variable interest entity (“VIE”) established by means other than voting
interests. FIN No. 46 also requires consolidation of a VIE by an
enterprise that holds such a controlling interest. In December 2003,
FASB completed its deliberations regarding the proposed modification to FIN
no.
46 and issued Interpretation Number 46 (R) “Consolidation of Variable Interest
Entities – an Interpretation of ARB No. 51” (“FIN No. 46 (R)”). The
decisions reached included a deferral of the effective date and provisions
for
additional scope exceptions for certain types of variable
interests. Application of FIN No. 46 (R) is required in financial
statements of public entities that have interests in VIEs or potential VIEs
commonly referred to as special-purpose entities for periods ending after
December 15, 2004. The adoption of FIN No. 46 (R) is not expected to
have an impact on the Company’s consolidated financial position, results of
operations or cash flows.
16
In
April
2003, the FASB issued SFAS No. 149, “Amendment of Statement 133 on Derivative
Instruments and Hedging Activities.” SFAS No. 149 amends and
clarifies financial accounting and reporting for derivative instruments embedded
in other contracts and for hedging activities under SFAS No. 133, “Accounting
for Derivative Instruments and Hedging Activities.” It is effective
for contracts entered into or modified after June 30, 2003, except as stated
within the statement, and should be applied prospectively. Management
believes the provisions of this Standard currently have no effect on our
financial position or results of operations.
In
May
2003, the FASB issued SFAS No. 150, “Accounting for Certain Financial
Instruments with Characteristics of Both Liabilities and
Equity.” SFAS No. 150 establishes standards for how a company
classifies and measures certain financial instruments with characteristics
of
both liabilities and equity. SFAS No. 150 is effective for financial
instruments entered into or modified after May 31, 2003, and otherwise is
effective at the beginning of the first interim period beginning after September
15, 2003. Management believes the provisions of this Standard
currently have no effect on our financial position or results of
operations.
Prior
to
December 31, 2002, the Company received grants from the German government which
were used to fund research and development activities and the acquisition of
equipment. Revenue from grants for the reimbursement of research and
development expenses were offset against research and development expenses
when
the related expenses are incurred. Grants related to the acquisition
of tangible property were recorded as a reduction of the property's historical
cost.
The
following discussion contains forward-looking statements that are subject to
business and economic risks and uncertainties, and the Company's actual results
could differ materially from these forward-looking statements. The
following discussion regarding the financial statements of the Company should
be
read in conjunction with the financial statements and notes
thereto.
FISCAL
2005 COMPARED TO FISCAL 2004
FINANCIAL
POSITION
The
Company’s current assets decreased by $454,201, or 93%, from June 30, 2004
to $38,281 at June 30, 2005. The decrease is primarily
attributable to a significant decrease in cash and taxes
receivable. The decrease in cash and taxes receivable results
primarily from funding the current year’s operations of the Company
with minimal revenues in the year ended June 30, 2005.
The
Company's net property and equipment decreased $50,645 or 50%, from June 30,
2004 to $33,608 at June 30, 2005. The decrease is primarily
attributable to the current year depreciation of approximately
$66,894.
The
Company funded its operations primarily through the sale of common
stock. The Company’s stockholders’ equity decreased $517,126, to
$162. The primary decrease is caused by the Company's current year
net loss of $704,612.
REVENUES. Revenues
increased 51% to $45,212 during the year ended June 30, 2005 from $23,228 during
2004. 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 totalling $44,051
during the 2005 fiscal year, a 64% increase over the prior year.
RESEARCH
AND DEVELOPMENT. Research and development expenses decreased 52% to
$426,831 in 2005 from $886,962 in 2004. This decrease of $460,131 was
primarilty the result of decreased operations, and a decreased cash flow during
the period.
GENERAL
AND ADMINISTRATIVE. General and administrative expenses decreased 28%
to $480,666 in 2005 from $671,383 in 2004. This decrease of $190,717
is attributed to decreases in operating expenses due to the ongoing cost-cutting
programs.
NET
LOSS. As a result of the above factors, the Company's consolidated
net loss was approximately $705,000, or $0.02 per common share, in 2005,
compared to $1,574,517, or $0.04 per common share, in 2004.
17
LIQUIDITY
AND CAPITAL RESOURCES
For
the
year ended June 30, 2005, net cash used in operating activities decreased to
$414,593 from $1,464,276 for the year ended June 30, 2004, primarily related
to
a decrease in the Company’s consolidated net loss as a result of the ongoing
refocusing program.
For
the
year ended June 30, 2005, net cash flows from investing activities decreased
to
$1,631from a surplus of $803,408 for the year ended June 30,
2004. The principal decrease is due to the maturity of marketable
securities in prior years.
The
Company had a working capital deficit of $126,750 at June 30, 2005, compared
to
working capital of $400,759 at June 30, 2004, an overall decrease of $527,509,
due primarily to the Company’s net loss for the year.
The
Company incurred a net loss applicable to common stockholders of $704,612 and
used cash in operating activities of $414,593 for the year ended June 30,
2005. These 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 have started in the course of the
first quarter of our current fiscal year. 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 fulfil 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.
18
ITEM
7: FINANCIAL STATEMENTS
SANGUI
BIOTECH INTERNATIONAL, INC.
CONSOLIDATED
FINANCIAL STATEMENTS
June
30,
2005
19
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the
Board of Directors
Sangui
Biotech International, Inc. and Subsidiaries
Witten
Germany
We
have
audited the accompanying consolidated balance sheet of Sangui Biotech
International, Inc. and Subsidiaries (the Company) as of June 30, 2005
and the
related consolidated statement of operations, stockholders’ equity (deficit),
comprehensive income, and cash flows for the two years ended June 30, 2004
and
2005. These consolidated financial statements are the responsibility
of the Company’s management. Our responsibility is to express an
opinion on these consolidated financial statements based on our
audit.
We
conducted our audit in accordance with standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about
whether
the consolidated financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the consolidated financial
statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall consolidated 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. and Subsidiaries as of June 30, 2005 and the results
of
their operations and their cash flows for the two years ended June 30,
2004 and
2005 in conformity with U.S. generally accepted accounting
principles.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. As discussed in Note 1
to the consolidated financial statements, the Company has no significant
operating results to date, which raises substantial doubt about its ability
to
continue as a going concern. Management’s plans in regard to these
matters are also described in Note 1. The consolidated financial
statements do not include any adjustments that might result from the outcome
of
this uncertainty.
/s/
HJ
& Associates, LLC
HJ
&
Associates, LLC
Salt
Lake
City, Utah
May
17,
2007
20
SANGUI
BIOTECH INTERNATIONAL, INC.
Consolidated
Balance Sheet
ASSETS
--------
June
30,
2005
----------------
CURRENT
ASSETS
Cash $ 9,497
Accounts
receivable 4,300
Inventory 7,063
Prepaid
expenses and other
assets 17,421
----------------
Total
Current
Assets 38,281
----------------
FIXED
ASSETS, NET
Property
and
equipment
33,608
----------------
Total
Fixed
Assets 33,608
----------------
OTHER
ASSETS
Patents
and licenses,
net 2,490
Other
miscellaneous
assets 90,814
----------------
Total
Other
Assets 93,304
----------------
TOTAL
ASSETS $ 165,193
=========
The
accompanying notes are an integral part of these consolidated financial
statements.
21
SANGUI
BIOTECH INTERNATIONAL, INC.
Consolidated
Balance Sheet (Continued)
LIABILITIES
AND STOCKHOLDERS' EQUITY
----------------------------------------------
June 30,
2005
-------------
CURRENT
LIABILITIES
Accounts
payable and accrued
expenses $ 140,899
Notes
payable 24,132
-------------
Total
Current
Liabilities
165,031
-------------
TOTAL
LIABILITIES
165,031
-------------
STOCKHOLDERS'
EQUITY
Preferred
stock, no par value, 5,000,000 shares
authorized,
no shares issued and
outstanding -
Common
stock, no par value, 50,000,000 shares
authorized,
47,503,749 shares issued and outstanding
shares
issued and
outstanding
18,746,100
Additional
paid in
capital 1,986,398
Treasury
stock
(82,357)
Accumulated
other comprehensive
income 383,407
Accumulated
deficit (21,033,386)
----------------
Total
Stockholders'
Equity
162
----------------
TOTAL
LIABILITIES AND STOCKHOLDERS'
EQUITY $ 165,193
==========
The
accompanying notes are an integral part of these consolidated financial
statements.
22
SANGUI
BIOTECH INTERNATIONAL, INC.
Consolidated
Statements of Operations
For the Years Ended
June
30,
------------------------------------
2005
2004
----------------- -----------------
REVENUES $
45,212
$ 23,228
COST
OF
GOODS
SOLD
44,051
16,438
----------------- -----------------
GROSS
PROFIT
1,161
6,790
----------------- -----------------
OPERATING
EXPENSES
Research
and
development
426,831
886,962
General
and
administrative
480,666 671,383
Depreciation
and
amortization 66,894 86,621
----------------- -----------------
Total
Operating
Expenses
974,391 1,644,966
----------------- -----------------
OTHER
INCOME (EXPENSE)
Interest
expense
(3,498)
-
Interest
income
704
40,653
Other
income 271,412
23,006
----------------- -----------------
Total
Other Income
(Expense) 268,618
63,659
----------------- -----------------
NET
LOSS
(704,612) (1,574,517)
OTHER
COMPREHENSIVE INCOME
Foreign
currency translation
adjustments
(145,262)
30,353
Unrealized
gain on marketable
securities
-
5,610
----------------- -----------------
COMPREHENSIVE
LOSS $
(849,874) $ (1,538,554)
========== ==========
NET
LOSS
AVAILABLE TO COMMON
SHAREHOLDER
PER COMMON
SHARE $
(0.02)
$ (0.04)
========== ==========
BASIC
AND
DILUTED WEIGHTED AVERAGE
NUMBER
OF COMMON SHARES
OUTSTANDING 44,312,968
40,655,363
========== ==========
The
accompanying notes are an integral part of these consolidated financial
statements.
23
SANGUI
BIOTECH INTERNATIONAL, INC
Consolidated
Statements of Stockholders' Equity (Deficit)
June
30,
2004 and 2005
Accumulated
Common
Stock
Additional
Other
------------------------------------ Paid-in
Treasury Comprehensive Accumulated
Shares Amount
Capital
Stock Loss
Deficit
-------------- ------------------ ---------------- ------------ ------------------ ------------------
Balance,
June 30, 2003
40,655,363
18,345,491 2,000,000
-
492,706 $ (18,754,257)
Currency
translation
adjustment -
-
-
-
30,353
-
Unrealized
gain on
marketable
securities -
- -
-
5,610
-
Purchase
of treasury
stock -
- -
28,098
-
-
Net
loss -
- -
-
-
(1,574,517)
--------------- ----------------- ---------------- ------------ ---------------- -----------------
Balance
June 30, 2004
40,655,363
18,345,491
2,000,000
28,098
528,669 20,328,774
Issue
of
common stock
to
employees-no
consideration 1,200,000
100,125
-
-
-
-
Currency
translation
adjustment - -
-
-
(145,262) -
Purchase
of treasury
stock -
-
-
118,116 -
-
Sale
of
treasury
stock -
- (13,602)
(63,907)
-
-
Proceeds
from sale
of
stock 5,648,386
300,484
- -
-
-
Net
loss - - -
-
-
(704,612)
---------------- ------------------ ---------------- --------------- --------------- ------------------
Balance
June 30, 2005 47,503,749
$ 18,746,100 $
1,986,398 $
82,357 $ 383,407
$ (21,033,386)
========= ========== ========= ========= =========
===========
The
accompanying notes are an integral part of these consolidated financial
statements.
24
SANGUI
BIOTECH INTERNATIONAL, INC.
Consolidated
Statements of Cash Flows
For the Year Ended
June 30,
-----------------------------------------
2005
2004
----------------- ------------------
CASH
FLOWS FROM OPERATING ACTIVITIES
Net
loss
$
(704,612) $
(1,574,517)
Adjustments
to reconcile net loss to net
cash
used by operating activities:
Depreciation
and
amortization 66,894
86,621
Stock
compensation 100,125
-
Gain
on sale of treasury
stock
(3,101)
-
Changes
in operating assets and liabilities:
Accounts
and
taxes receivable
128,286 (27,346)
Inventory (7,063)
-
Prepaid
expenses and other
assets
(50,298) 91,059
Accounts
payable and accrued
expenses
55,176
(40,093)
--------------- -----------------
Net
Cash Used in Operating
Activities (414,593)
(1,464,276)
--------------- -----------------
CASH
FLOWS FROM INVESTING ACTIVITIES
Maturities
of marketable
securities
- 818,400
Purchases
of marketable
securities
- (26,997)
Purchases
of
patents (1,470)
-
Collection
of notes
receivable
-
20,000
Purchases
of property and
equipment
- (7,995)
Sales
of property and
equipment
3,101
-
--------------- ----------------
Net
Cash Provided (Used) by Investing
Activities 1,631 803,408
--------------- ----------------
CASH
FLOWS FROM FINANCING ACTIVITIES
Proceeds
from issuance of common
stock
300,484
-
Proceeds
from notes
payable 24,132
-
Purchase
of treasury
stock
(118,166)
(28,098)
Sale
of treasury
stock 50,305 -
--------------
--------------
Net
Cash Provided by Financing
Activities 256,755
(28,098)
--------------
--------------
EFFECT
OF
EXCHANGE RATE
CHANGES
(145,255) 43,394
-------------- --------------
NET
DECREASE IN
CASH
(301,462)
(645,572)
CASH,
BEGINNING OF
PERIOD 310,959
956,531
----------------
----------------
CASH,
END
OF
PERIOD $
9,497 $ 310,959
=========
=========
The
accompanying notes are an integral part of these consolidated financial
statements.
25
SANGUI
BIOTECH INTERNATIONAL, INC.
Consolidated
Statements of Cash Flows (continued)
For
the Year Ended
June
30,
------------------------------------
2005
2004
--------------- --------------
SUPPLEMENTAL
DISCLOSURES OF
CASH
FLOW INFORMATION
CASH
PAID
FOR:
Interest $ 2,834 $
-
Income
Taxes $ - $
-
The
accompanying notes are an integral part of these consolidated financial
statements.
26
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
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) as well as 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 (see Note 7). The Singapore office was closed effective December 31,
2002.
The
Company incurred a net loss applicable to common stockholders of $704,612 and
used cash in operating activities of $414,593 for the year ended June 30, 2005.
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.
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. Certain amounts in fiscal 2004 have been reclassified to conform
to the fiscal 2005 presentation. These reclassifications have no effect on
previously reported net loss.
27
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
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, 2005.
28
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
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, 2005 and 2004 was
approximately $66,894 and $77,600, 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, 2005 and 2004 was
approximately $0 and $8,661, respectively.
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, 2005, 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 $426,831 and
$886,962 during the fiscal years ended June 30, 2005 and 2004,
respectively.
Grants
---------
The
Company received grants from the German government which were used to fund
research and development activities and the acquisition of
equipment. Revenue from grants for the reimbursement of research and
development expenses is offset against research and development expenses when
the related expenses we incurred. The Company had no active grants
during the fiscal years ended June 30, 2005 and 2004. However, the
Company did derive other income from additional reimbursements pertaining to
the
grants, during the fiscal years ended June 30, 2005 and 2004.
29
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
NOTE
1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
-------------------------------------------------------------------------------------------------------------------------
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.
Accounting
for Stock-Based Compensation
---------------------------------------------------------
The
Company accounts for stock-based compensation issued to employees using the
intrinsic value based method as prescribed by Accounting Principles Board
Opinion No. 25, "Accounting for Stock Issued to Employees" ("APB 25"), as
amended. The Financial Accounting Standards Board ("FASB") has issued SFAS
No.
123, "Accounting for Stock-Based Compensation" , which, if fully adopted,
changes the method of accounting for all stock-based compensation to the fair
value method.
In
December 2002, SFAS No. 148, "Accounting for Stock-Based Compensation -
Transition and Disclosure," was issued. SFAS No. 148 amends SFAS No. 123 to
provide alternative methods of transition for a voluntary change to the fair
value based method of accounting for stock-based compensation. In addition,
SFAS
No. 148 amends the disclosure requirements of SFAS No. 123 to require prominent
disclosures in both annual and interim financial statements about the method
of
accounting for stock-based employee compensation and the effect of the method
used on reported results. The provisions of SFAS No. 148 are effective for
financial statements for fiscal years ending after December 15,
2002.
There
is
no stock-based employee compensation expense under APB 25 or pro forma
adjustment under SFAS No. 123 for fiscal 2005 or 2004, as the Company did not
issue any stock-based compensation to employees since June 30,
2002.
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, 2005 and 2004,
the
Company had no potentially dilutive securities that would effect the loss per
share if they were to be dilutive.
30
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
NOTE
1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
-------------------------------------------------------------------------------------------------------------------------
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.
Inventory
------------
Inventory
is stated at the lower of cost (computed on a first-in, first-out basis)
or
market value. At June 30, 2005 all inventory consists of finished
goods. Inventory is evaluated periodically by management for
potential impairment. During the years ended June 30, 2005 and 2004,
the Company recognized no impairment expense pertaining to
inventory.
Trade
Receivables
-------------------------
The
Company periodically reviews its trade receivables for potential collectibility
issues. The Company has implemented the policy to charge-off trade
receivables older than 120 days outstanding as bad-debt
expense. During the years ended June 30, 2005 and 2004, the Company
recorded no bad debt expense pertaining to uncollectible trade
receivables.
New
Accounting Pronouncements
----------------------------------------------
In
January 2003, the FASB issued Interpretation Number 46, "Consolidation of
Variable Interest Entities" ("FIN No. 46"). This Interpretation of Accounting
Research Bulletin ("ARB") No. 51, "Consolidated Financial Statements," provides
guidance for identifying a controlling interest in a variable interest entity
("VIE") established by means other than voting interests. FIN No. 46 also
requires consolidation of a VIE by an enterprise that holds such a controlling
interest. In December 2003, FASB completed its deliberations regarding the
proposed modification to FIN no. 46 and issued Interpretation Number 46 (R)
"Consolidation of Variable Interest Entities - an Interpretation of ARB No.
51"
("FIN No. 46 (R)"). The decisions reached included a deferral of the effective
date and provisions for additional scope exceptions for certain types of
variable interests. Application of FIN No. 46 (R) is required in financial
statements of public entities that have interests in VIEs or potential VIEs
commonly referred to as special-purpose entities for periods ending after
December 15, 2004. The adoption of FIN No. 46 (R) is not expected to have an
impact on the Company's consolidated financial position, results of operations
or cash flows.
In
April
2003, the FASB issued SFAS No. 149, "Amendment of Statement 133 on Derivative
Instruments and Hedging Activities." SFAS No. 149 amends and clarifies financial
accounting and reporting for derivative instruments embedded in other contracts
and for hedging activities under SFAS No. 133, "Accounting for Derivative
Instruments and Hedging Activities." It is effective for contracts entered
into
or modified after June 30, 2003, except as stated within the statement, and
should be applied prospectively. Management believes the provisions of this
Standard currently have no effect on our financial position or results of
operations.
In
May
2003, the FASB issued SFAS No. 150, "Accounting for Certain Financial
Instruments with Characteristics of Both Liabilities and Equity". SFAS No.
150
establishes standards for how a company classifies and measures certain
financial instruments with characteristics of both liabilities and equity.
SFAS
No. 150 is effective for financial instruments entered into or modified after
May 31, 2003, and otherwise is effective at the beginning of the first interim
period beginning after September 15, 2003. Management believes the provisions
of
this Standard currently have no effect on our financial position or results
of
operations.
31
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
NOTE
1 -
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
-------------------------------------------------------------------------------------------------------------------------
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. [Missing Graphic Reference]
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.
Major
Customers
-----------------------
During
the years ended June 30, 2005 and 2004 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 88% of the Company’s gross revenues for the year
ended June 30, 2005.
32
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
NOTE 2 - PROPERTY AND EQUIPMENT
------------------------------------------------------------
Property
and equipment consists of
the following at June 30, 2005:
Technical
and laboratory
equipment $
645,214
Leasehold
improvements 388,855
Office
equipment
142,630
Office
furniture
26,962
Other
1,324
---------------
1,204,985
Less
accumulated depreciation and
amortization
(1,171,377)
---------------
$ 33,608
==========
NOTE 3 - PATENTS
AND LICENSES
-----------------------------------------------------
At
June
30, 2005, patents and licenses totaled $124,186 less accumulated amortization
of
$121,696.
NOTE 4 - 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, 2005 and
2004, and during the years ended June 30, 2005 and 2004, 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. As of June 30, 2005 the Company held 432,000 shares of
treasury stock. The shares are valued at cost.
33
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
NOTE
5 - INCOME TAX PROVISION
-----------------------------------------------------
Deferred
taxes are provided on a liability method whereby deferred tax assets are
recognized for deductible temporary differences and operating loss and tax
credit carryforwards and deferred tax liabilities are recognized for taxable
temporary differences. Temporary differences are the differences
between the reported amounts of assets and liabilities and their tax
bases. Deferred tax assets are reduced by a valuation allowance when,
in the opinion of management, it is more likely than not that some portion
or
all of the deferred tax assets will not be realized. Deferred tax
assets and liabilities are adjusted for the effects of changes in tax laws
and
rates on the date of enactment.
Net
deferred tax assets consist of the following components as of June 30, 2005
and
2004:
June
30, June
30,
2005 2004
Deferred
tax assets:
NOL
Carryover
$6,900,000
$6,800,000
Deferred
Tax
Liabilities:
- -
Valuation
allowance (6,900,000) (6,800,000)
Net
deferred tax
asst $ -
$
-
======= =======
The
income tax provision differs from the amount of income tax determined by
applying the U.S. federal and state income tax rates of 39% to pretax income
from continuing operations for the periods ended June 30, 2005 and 2004 due
to
the following:
June
30, June 30,
2005
2004
Book
income
(loss) $
(274,799)
$ (538,000)
Common
stock issued for
services
39,049 -
State
and local income
taxes
-
(147,000)
Valuation
allowance 235,750 685,000
$ -
$
-
======= =======
At
June
30, 2005, the Company had net operating loss carryforwards of approximately
$6,900,000 that may be offset against future taxable income from the year
2005
through 2025. No tax benefit has been reported in the accompanying financial
statements since the potential tax benefit is offset by a valuation allowance
of
the same amount.
Due
to
the change in ownership provisions of the Tax Reform Act of 1986, net operating
loss carryforwards for Federal income tax reporting purposes are subject
to
annual limitations. Should a change in ownership occur, net operating
loss carryforwards may be limited as to use in future years.
NOTE
6 - 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,
2005
and 2004:
2005 2004
---------------- -----------------
Numerator
for basic and diluted loss per common
share
–
net
loss
$ (704,612)
$ (1,574,517)
========== =========
Denominator
for basic and diluted loss per common
share
– weighted average
shares 44,312,968 40,655,363
==========
=========
Basic
and
diluted loss per common
share
$ (0.02)
$ (0.04)
==========
=========
NOTE
7 -
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 2005 and 2004.
34
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
NOTE
8 - COMMITMENTS AND CONTINGENCIES
-------------------------------------------------------------------------
Operating
Leases
------------------------
The
Company leases its office and laboratory facilities in Germany under an
operating lease that expires in May, 2006. Future minimum lease
payments under this lease at June 30, 2005 are approximately $60,000 for
fiscal
2006. Rent expense was approximately $68,000 and $70,000 for the
years ended June 30, 2005 and 2004, respectively.
The
Company entered into an automobile lease agreement in June, 2004. The
lease was for a term of 24 months, and expired on June 15, 2006. The
Lease called for monthly payments of approximately $1,130. Future
minimum lease payments under this lease at June 30, 2005 were approximately
$13,556. Automobile lease expense was approximately $13,556 and $-0-
for the years ended June 30, 2005 and 2004, respectively.
Litigation
------------
The
Company is, from time to time, involved in various litigations resulting
in the
ordinary course of operating its business. Management is currently not able
to
predict the outcome of these cases. However, management believes that the
amount
of ultimate liability, if any, with respect to these actions will not have
a
material effect on the Company's financial position and results of
operations.
On
November 27, 2003, the company was served with a lawsuit, Landgericht Bochum
Court, Case No. 6 O 435/03. The lawsuit named, among others,
SanguiBioTech AG as defendant. The plaintiff alleged that the
Company, had neglected its duty in dealing with some of the plaintiff’s Sangui
BioTech International, Inc. shares. A judgement was handed down on
July 28th, 2004 whereby the plaintiff’s action was been dismissed. No
appeal has been lodged. The Company recognized no financial impact
from this litigation.
On
August
4, 2003, SanguiBioTech AG filed a lawsuit against a former director of SGBI,
claiming that some payments incurred by the defendant were unjustified under
German law, Landgericht Munich I Court, Case No. 34 O 14027/03). The
defendant denied that the claim is justified and brought forward the opinion
that he could claim additional fees. On February 10, 2005, the
lawsuit was settled by order of the Court. All claims and
counterclaims between the parties were irrevocably dismissed.
On
June
15, 2005, SanguiBioTech GmbH was served with a lawsuit, Amtsgericht Witten,
Case
No. 2 C 429/05. The plaintiff is a supplier of packaging foils for
certain medical products. He claims payment of invoices amounting to
approximately $ 8,500. The Company had rejected the delivery of the
goods covered by the invoices due to poor quality. The claim was
settled by order of the Court on September 7, 2005, whereby Sangui agreed
to pay
a lesser amount of approximately $6,406, including court
fees.
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 and no liabilities have been recorded
for these indemnities and guarantees in the accompanying consolidated balance
sheet.
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.
35
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
NOTE
9 -
STOCK-BASED COMPENSATION
--------------------------------------------------------------
The
Company has applied the disclosure provisions of Statement of Financial
Accounting Standards No. 148, "Accounting for Stock-Based Compensation --
Transition and Disclosure -- An Amendment of FASB Statement No. 123," for the
years ended December 31, 2003 and 2002. Issued in December 2002, SFAS No. 148
amends SFAS No. 123, "Accounting for Stock-Based Compensation" to provide
alternative methods of transition for a voluntary change to the fair value
based
method of accounting for stock-based compensation. In addition, SFAS No. 148
amends the disclosure requirements of SFAS No. 123 to require prominent
disclosures in both annual and interim financial statements about the method
of
accounting for stock-based employee compensation and the effect of the method
used on reported results. As permitted by SFAS No. 148, the Company continues
to
account for stock options under APB Opinion No. 25, under which no compensation
has been recognized. There were no stock options granted or exercised during
this reporting period. Had there been, the Company would have applied the fair
value recognition disclosure provisions of SFAS No. 123, as amended by SFAS
No.
148, to stock-based compensation. As a result, no pro forma disclosures are
presented.
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
10 -
NOTE PAYABLE
--------------------------------------
On
June
16, 2005 the Company consummated into a note payable agreement with an unrelated
third party, whereby the Company may borrow up to $46,936. As of June
30, 2005, the Company had borrowed $24,132. Subsequent to year-end,
the Company borrowed the remaining $22,804. The note accrues interest
at a rate of 6.0% per annum, and becomes due one week after the Company’s
receipt of certain government subsidies.
NOTE
11 –
SUBSEQUENT EVENTS
--------------------------------------------------
In
August, 2005 the Company sold 1,000,000 shares of its common stock to a European
investor yielding cash contribution of $87,500. In addition, the
Company sold 1,495,960 shares of its common stock to a European investor
yielding a cash inflow of $135,758
Subsequent
to the period covered by this report, from January 2006 through January 2007,
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 was $512,959.
Loan
Agreement with FID Esprit AG
Subsequent
to the period covered by this report, 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.
36
SANGUI
BIOTECH INTERNATIONAL, INC.
Notes
to
the Consolidated Financial Statements
For
the
year ended June 30, 2005
NOTE
11 –
SUBSEQUENT EVENTS (Continued)
-----------------------------------------------------------------
Loan
Agreement with Feedback AG
Subsequent
to the period covered by this report, 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
Subsequent
to the period covered by this report, 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. 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.
Additional
Loans
From
January 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, 3) chitosin, and 4) 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.
37
ITEM 8. CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON AN ACCOUNTING AND FINANCIAL
DISCLOSURE
The
Board of Directors of the companies resolved as of September 9, 2004, to
conclude the association with Corbin & Company, LLP, effective June 30,
2004. The company has asked HJ & Associates, Salt Lake City,
Utah, to carry out the audit of its June 30, 2005 and 2004, financial statements
as well as the annual reports on Forms 10-KSB.
There
were no disagreements between the Company and Corbin & Company regarding the
company’s accounting principles and procedures.
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
Distribution
Agreement with Karl Beese GmbH
On
April 14, 2005, the Company entered
into a distribution agreement with Karl Beese GmbH. Under the
distribution agreement, Karl Beese GmbH will have exclusive rights to market
and
distribute the Company’s Chitosan based wound pads to Europe for a period of
five years from execution.
Loan
Agreement with FID Esprit AG
Subsequent
to the period covered by
this report, 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
Subsequent
to the period covered by this report, 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 $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.
38
Second
Loan Agreement with Feedback AG
Subsequent
to the period covered by
this report, 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 $18,000 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.
Subsequent
to the period covered by
this report, 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.
Subsequent
Sales of Securities
Subsequent
to the period covered by
this report, in August 2005, the Company sold 1,000,000 shares of its common
stock to a European investor yielding cash contribution of
$87,500. No underwriters were used. 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.
Subsequent
to the period covered by
this report, in January 2006, the Company sold 1,495,960 shares of its common
stock to a European investor yielding a cash inflow of $512,959. No
underwriters were used. 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.
Subsequent
Additional Loans to the Company
Subsequent
to the period covered by
this report, from January 2006 through 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 on the fifth anniversary of its 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 Borrower’s Common Stock at any time prior to full repayment
or the Due Date. The total amount borrowed under these notes was
$512,959.
39
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, 2005 were as follows:
Name
|
|
Age
|
|
Positions
and Offices
|
Directorship
Term
|
Period
of Service as a Director
|
|
|
|
|
|
|
|
Prof.
Wolfgang Barnikol, M.D., Ph.D:
|
|
70
|
|
Chairman,
President, Chief Executive Officer, Executive Director
|
One
Year
|
Apr
18, 2001
|
|
|
|
|
|
|
|
Joachim
Fleing, Ph.D..
|
|
52
|
|
Non-Executive
Director
|
One
Year
|
Dec
13, 2003
|
|
|
|
|
|
|
|
Prof.
Joachim Lutz, M.D., Ph.D.
|
|
71
|
|
Non-Executive
Director
|
One
Year
|
Aug,
1997
|
|
|
|
|
|
|
|
Thomas
Striepe.
|
|
41
|
|
Non-Executive
Director
|
One
Year
|
Feb
7, 2005
|
|
|
|
|
|
|
|
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 2005 and
2004.
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, 2005, are set out below:
PROFESSOR
WOLFGANG K. R. BARNIKOL, M.D., Ph.D., Chairman, President, Chief Executive
Officer, Chief Financial Officer, and Executive Director of SGBI, 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.
40
PROFESSOR
JOACHIM LUTZ, M.D., Non-Executive Director, 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, Non-Executive Director, 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, Non-Executive Director, 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
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.
41
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, 2005, 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.
42
ITEM
10. EXECUTIVE COMPENSATION AND OTHER INFORMATION
Summary
Compensation Table
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
($)(1)
(j)
|
Prof.
Wolfgang Barnikol
Chairman,
CEO, CFO
|
2005
2004
2003
|
38,134
126,858
115,927
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
38,134
126,858
115,927
|
Patrick
Onishi
Secretary
|
2005
2004
2003
|
0
0
13,389
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
13,389
|
(1)
|
All
figures are expressed in United States Dollars (“USD”); for the German
management personnel, the EURO or DM was converted to USD as of the
fiscal
year end of each year.
|
Narrative
Disclosure to Summary Compensation Table
The
Company has an agreement with
Professor Barnikol, the Company’s President and CEO, pursuant to which he is
entitled to 3% royalties of gross revenues earned with any product based on
his
inventions (See below: Item 12 Certain Relationships and Related
Transactions). No royalties were paid or earned in fiscal 2005 and
2004.
There
are no other employment
contracts, compensatory plans or arrangements, including payments to be received
from the Company with respect to any executive officer, that would result in
payments to such person because of his or her resignation, retirement or other
termination of employment with the Company, or its subsidiaries, any change
in
control, or a change in the person’s responsibilities following a change in
control of the Company.
There
are no agreements or
understandings for any executive officer to resign at the request of another
person. None of our executive officers acts or will act on behalf of or at
the
direction of any other person.
43
Outstanding
Equity Awards at Fiscal Year-End Table and Narative
The
Company had no outstanding equity
awards at fiscal year-end.
Compensation
of Directors
The
table below summarizes all
compensation awarded to, earned by, or paid to our Directors for all services
rendered in all capacities to us for the fiscal periods indicated.
Name
(a)
|
Fees
Earned or Paid in Cash
(b)
|
Stock
Awards
($)
(c)
|
Option
Awards
($)
(d)
|
Non-Equity
Incentive Plan Compensation
($)
(e)
|
Nonqualified
Deferred Compensation Earnings
($)
(f)
|
All
Other Compensation
($)
(g)
|
Total
($)
(j)
|
Prof.
Wolfgang Barnikol
|
2005
2004
2003
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
$0
$0
$0
|
Joachim
Lutz
|
2005
2004
2003
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
$0
$0
$0
|
Thomas
Striepe
|
2005
2004
2003
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
0
0
0
|
$0
$0
$0
|
Joachim
Fleing
|
2005
2004
2003
|
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.
44
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.
Security
Ownership of Certain Beneficial Owners
As
of June 30, 2005 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, 2005, 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)
|
3.9
%
|
Common
Stock
|
Dr.
Joachim Fleing
Am
Vogelherd 43
35043
Marburg
Germany
|
202,000
|
0.4
%
|
Common
Stock
|
Joachim
Lutz
|
0
|
0.0%
|
Common
Stock
|
Thomas
Striepe
|
0
|
0.0%
|
Common
Stock
|
All
Officers and Directors as a Group (4 persons)
|
2,055,600
|
4.3
%
|
(1)
This
amount includes 1,153,600 shares held in the name of Dr. Doris Barnikol-Keuten,
Dr. Wolfgang Barnikol’s spouse.
45
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
Subsequent
to the period covered by
this report 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.
46
ITEM
13 EXHIBITS
(a)
Index
to Exhibits
Exhibit
No.
2.1
(1)
Exchange Agreement between MRC Legal Services LLC and SanguiBioTech
International, Inc., dated of March 31, 2000 (1)
3.1
(1)
Articles of Incorporation of SGBI (1)
3.2
(1)
Bylaws of SGBI(1)
3.3
Articles of Association of GlukoMeditech Aktiengesellschaft (2)
3.4
Articles of Association of SanguiBiotech Aktiengesellschaft (2)
3.5
Memorandum and Articles of Association of Sangui Biotech Singapore Pte. Ltd.
(3)
4.1
Stock
Option Agreement between Professor Wolfgang Barnikol and Sangui Biotech
International, Inc. dated October 12, 2000 (2) (cancelled as of June 30,
2003).
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)
21.1
Subsidiaries of SGBI (2)
31.1
Certification of President, Chief Executive Officer and Chief Financial Officer
pursuant to Rule 13a-14(a) and 15d-14(a), filed herewith.
32
Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, filed herewith.
(1)
Filed
as an Exhibit to the Report on Form 8-K filed on or about April 4, 2000 and
incorporated herein by reference.
(2)
Filed
as an Exhibit to the original Report on Form 10-KSB filed on October 13,
2000.
(3)
Filed
as an Exhibit to the amended Report on Form 10-KSB filed on November 20,
2000.
(4)
Filed
as an Exhibit to the Report on Form 10-KSB filed on September 28,
2002.
47
ITEM
14. Principal Accountant Fees and Services.
Independent
Public Accountants
The
Company's independent accountants
for the fiscal year ended June 30, 2004 was Corbin & Company, LLP, however,
Corbin & Company, LLP only completed the audit of June 30, 2003; HJ &
Associates, of Salt Lake City, Utah, were responsible for completing the audit
of June 30, 2004.
(a) Audit
Fees. During the fiscal year ended 2004, the aggregate fees
billed by Corbin & Company, LLP for services rendered for the review of the
financial statements included in our quarterly reports on Form 10-QSB or
services provided in connection with the statutory and regulatory filings or
engagements for that fiscal year, were $51,699.
(b) Audit-Related
Fees. For the fiscal year ended 2004, fees billed by Corbin &
Company, LLP, were an aggregate $0 for any audit-related services other
than as
set forth in paragraph (a) above.
(c) Tax
Fees. For the fiscal year ended 2004, Corbin & Company, LLP
did not bill any fees for tax compliance services. The auditors did
not provide tax-planning advice for the fiscal year ended 2004.
(d) All
Other Fees. None.
The
Company’s independent accountants for the fiscal year ended June 30, 2005 were
HJ & Associates, LLP.
(a) Audit
Fees. For the fiscal years ended 2005 and 2004, the aggregate
fees billed by HJ & Associates, LLP 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 $48,000 and $17,500 respectively.
(b) Audit-Related
Fees. For the fiscal years ended 2005 and 2004, fees billed by HJ
& Associates, LLP, 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 2005 and 2004, HJ &
Associates, LLP did not bill any fees for tax compliance
services. The auditors did not provide tax-planning advice for the
fiscal years ended 2005 and 2004.
(d) All
Other Fees. None.
48
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Company has
duly
caused this report on Form 10-KSB to be signed on its behalf by the undersigned
hereunto duly authorized.
SANGUI
BIOTECH INTERNATIONAL, INC.
/s/
Wolfgang Barnikol
Wolfgang Barnikol
President and Director
|
June
11, 2007 |
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/
Wolfgang
Barnikol
Wolfgang
Barnikol, M.D., Ph.D
|
President,
Chief Executive Officer and Director
|
June
11, 2007
|
/s/
Joachim
Lutz
Joachim
Lutz, M.D.
|
Director
|
June
13, 2007
|
/s/
Thomas Striepe
Thomas
Striepe
|
Director
|
June
13, 2006
|
/s/
Joachim Fleing
Joachim
Fleing, Ph.D
|
Director
|
June
7,
2007
|
49