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U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-KSB
(Mark One)
X Annual report under section 13 or 15(d) of the Securities Exchange Act
- --- of 1934 for the fiscal year ended December 31, 1999,
or
Transition report under section 13 or 15(d) of the Securities Exchange
- --- Act of 1934 for the transition period ended .
--------------
Commission File Number: 2-93277-D
MEDIZONE INTERNATIONAL, INC.
(Name of small business issuer in its charter)
Nevada 87-0412648
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
144 Buena Vista, P.O. Box 742, Stinson Beach, California 94970
(Address of principal executive offices) (Zip code)
Issuer's telephone number (415) 868-0300
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act: None
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 the Company was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes X No __
Check if there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-B contained in this form, and no disclosure will be contained, to
the best of Company'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. |X|
The issuer is in the development stage and had no revenues for its most recent
fiscal year.
The aggregate market value of voting common stock held by non-affiliates of the
issuer was $68,694,585 on March 23, 2000 based on the average bid and asked
prices of such stock as reported in the OTC Electronic Bulletin Board and the
"pink sheets" of the National Daily Quotation Bureau.
On March 23, 2000, the Company had 155,140,798 shares of common stock, par value
$.001 per share issued and outstanding.
Documents incorporated by reference. The registrant incorporates information
required by Part III (Items 10, 11, 12 and 13) of this report by reference to
the registrant's definitive proxy statement to be filed pursuant to Regulation
14A in connection with the Annual Meeting of Shareholders to beheld in May 2000.
Transitional Small Business Disclosure
Format (Check one):
Yes __ No x
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TABLE OF CONTENTS
PART I Page
Item 1. Description of Business 1
Item 2. Properties 12
Item 3. Legal Proceedings 12
PART II
Item 5. Market for Registrant's Common Equity and Related
Stockholder Matters 13
Item 6. Management's Discussion and Analysis or Plan of Operation 14
Item 7. Financial Statements 14
PART III
Item 9. Directors, Executive Officers, Promoters and Control Persons;
Compliance with Section 16(a) of the Exchange Act 14
Item 10. Executive Compensation 15
Item 11. Security Ownership of Certain Beneficial Owners and Management 15
Item 12. Certain Relationships and Related Transactions 16
Item 13. Exhibits and Reports on Form 8-K 16
Signatures 20
Exhibits Index 21
Financial Statements and Schedules F-1
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PART I
Item 1. Description of Business
General
Medizone International, Inc., a Nevada corporation (the "Company")
organized in 1986, is a development stage company. To date the principal
business of the Company has been limited to (i) seeking regulatory approval for
its drug, a precise mixture of ozone and oxygen called MEDIZONE(R) (sometimes
referred to in this report as the "Drug"), and its process of inactivating lipid
enveloped viruses for the intended purpose of decontaminating blood and blood
products and assisting in the treatment of certain diseases; and (ii) developing
or acquiring the related technology and equipment for the medical application of
its products, including its drug production and delivery system (the "Medizone
Technology").
The Drug is intended to be used as a therapeutic drug in humans to
inactivate certain viruses, and thereby afford a treatment for certain viral
diseases (including Human Immunodeficiency Virus ["HIV"], the AIDS-related
virus, Hepatitis B, Hepatitis C, Epstein-Barr, herpes and cytomegalovirus), and
to decontaminate blood and blood products.
Patents
The Company owns two key patents. The first is a United States process
patent (U.S. Patent No. 4,632,980) entitled, "Ozone Decontamination of Blood and
Blood Products" ("Patent No. 1"). The second patent is a related United States
equipment patent (U.S. Patent No. 5,052,382) entitled "Approaches for the
Control Generation and Administration of Ozone" ("Patent No. 2").
Patent No. 1, which covers a procedure for ozone decontamination of
blood and blood products through the treatment of blood and blood components, is
the Company's principal asset. It was purchased, together with rights to other
ozone-related inventions, from Immunologics Limited Partnership, L.P. ("ILP") in
1987, for 6,000,000 shares of the Company's common stock (the "Patent Purchase
Agreement"). John M. Kells, the general partner of ILP, was Chairman of the
Company's Board of Directors from November 1992 through September 1993.
The Patent Purchase Agreement requires the Company to pay to ILP an
annual royalty equal to 3% of the net receipts (defined as net receipts after
all credits, returns and customary deductions, and exclusive of all taxes) of
the Company received from the sale of any product, device, or apparatus
embodying Patent No. 1. The method covered by Patent No. 1 is the principal use
of ozone under study by the Company and is the method incorporated in its
regulatory applications. In June 1990, pursuant to the Company's request for
re-examination of Patent No. 1, the U.S. Patent Office issued a re-examination
certificate, confirming the patentability of the claims covered by Patent No. 1.
This patent will expire in 2003, subject to extension based upon the length of
time required to bring it to commercial fruition. The Company has been granted
foreign patents based on Patent No. 1 in Canada, the European Community,
Australia, Malaysia, Hong Kong and Japan. Applications are pending in Singapore.
The foreign patents began to be issued in 1990 and will expire in most cases 17
years after their respective dates of issuance.
Patent No. 2, which covers apparatus for the controlled generation,
monitoring and dosage of the Drug was developed by a consultant engineer to the
Company and issued and assigned to the Company in 1991. Patent No. 2 was
developed to provide the physical means to deploy Patent No. 1. The foreign
patent coverage of Patent No. 2 parallels the coverage of Patent No. 1.
In late 1996, the Company became aware that a United States patent had
been issued to a Canadian corporation, which the Company believed infringed on
the Medizone patents. Through its legal counsel, the Company took steps to
protect its patent rights and the Company believes that the infringing party has
stopped its infringing activities.
On July 30, 1998, the Company received recorded assignment US. Serial
No. 09/126,504 for a new patent application, External Application of
Ozone/Oxygen for Pathogenic Conditions. The Company believes that this
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application, if granted, would strengthen the Company's existing patents as it
addresses advanced developments with ozone generating equipment.
Research and Development
The Company does not own laboratories or other clinical research or
testing facilities. The Company's research and development activities to date
have been conducted under contract by outside laboratories and clinicians.
Gerard V. Sunnen, MD directs the Company's research and development activities.
Dr. Sunnen is a member of the Board of Directors and serves as President and
Director of Research of the Company.
Pre-clinical Studies
Pre-clinical Studies are non-human studies of the Drug and related
equipment. Since 1988, the Company has both sponsored and been the beneficiary
of research to (i) determine whether the use of ozone, either alone or with
other modalities, is efficacious in the treatment of certain diseases and (ii)
establish additional scientific evidence that ozone, through the use of the
patents or applications of scientific methodologies of a similar nature can
decontaminate blood or lipid enveloped viruses and thereby significantly
diminish the degree of transfusion related disease.
Pre-clinical projects sponsored by the Company include: (1) studies to
test ozone's ability to inactivate HIV, conducted at the State University of New
York Health Science Center at Syracuse; (2) a pilot animal study of the
potential toxicity of ozone, conducted by the Arnold & Marie Schwartz College of
Pharmacy and Health Science at Long Island University; and (3) studies
investigating the effects of ozone/oxygen admixtures on human peripheral blood,
including whole blood, serum and plasma, conducted by the Blood Bank of Mt.
Sinai Medical Center, New York City.
In 1990, the Canadian Blood Forces Program (under the aegis of the
Canadian Department of Defense and Agriculture and the Canadian Red Cross)
requested that the Company add the Medizone Technology to the other proprietary
technology being investigated as an experimental arm of an ozone-based blood
sterilization investigative program. The program was an attempt to develop an
effective technology for sterilizing whole blood and blood products. This
program, which was to study the Medizone Technology as it relates to the
inactivation of Simian Immunodeficiency Virus ("SIV"), included a live primate
model. The program continued until 1994, completing two out of the three
proposed stages, when the funding of the Canadian Blood Forces Program was
discontinued. The Company's management learned in late 1997 that the program
suffered difficulties with the ozone/bioserum interface that was used in the
study, which resulted in an inconsistent, difficult to accurately measure,
dosage of ozone. As a result, from a regulatory perspective the study yielded
results that could not be used due to the inability to specifically identify
dosage. From a practical standpoint, the Company views this study of the Drug as
a success, in that the treated simians never became ill through the entire
course of the trial period.
Governmental Regulation
The Drug, the Medizone Technology and related products are regulated
under the Federal Food, Drug and Cosmetic Act and related regulations (the "FDC
Act") by the Food and Drug Administration (the "FDA"). The FDA exercises broad
and extensive authority in regulating the development, production, importation,
distribution and promotion of "new drug" products and "investigational devices"
under the FDC Act and regulations.
Because ozone generation for purposes of interfacing with blood and
blood products is regarded as a new drug delivery, the Company is precluded from
selling or distributing the Drug or the Medizone Technology until after FDA
approval has been granted. To obtain FDA approval the Company will be required
to submit medical and scientific evidence sufficient to demonstrate that the
Drug and the Medizone Technology have been successfully used in pre-clinical
studies followed by well-controlled clinical studies using human volunteer
subjects. The FDA will not grant a new drug application ("NDA") unless it
contains sufficient medical evidence and data to permit a body of qualified and
experienced scientists to conclude that the new drug product is safe and
effective for its recommended and proposed medical uses. Historically, the FDA
has had a bias against treating humans with ozone, citing issues of safety.
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To initiate Phase I of human clinical studies required as part of a
NDA, an applicant must submit to the FDA an application for an Investigational
New Drug Exemption ("IND"), which contains adequate information to satisfy the
FDA that human clinical studies can be conducted without exposing the volunteer
human subjects to an unreasonable risk of illness or injury. The Company
submitted an IND application to the FDA on October 6, 1985, and requested FDA
approval to commence human clinical trials using ozone-oxygen to inactivate HIV.
The FDA deemed the IND application to be incomplete and required the Company to
conduct additional animal studies prior to commencing a large animal study
followed by human trials. In September 1994, the FDA inactivated the Company's
IND. The Company has no present plans to commence a large animal study, which
would require, as a precursor, additional small animal and laboratory work.
Accordingly, there can be no assurance that the Company's IND application will
ever be re-opened. Until an NDA has been granted to the Company, it may not
distribute ozone-generating devices in the United States, except to researchers
who agree to follow FDA guidelines, and provided the devices are labeled as
"Investigational Devices."
Because ozone has been used to treat humans in Europe for at least 30
years, the European Union (the "EU") is more accepting than the United States of
human clinical trials of ozone therapies. Management believes the Company should
pursue foreign Phase I human toxicity trials, as well as early stage efficacy
trials.
It is the Company's intention to pursue future trials in Canada as soon
as funding allows. The Company believes trials successfully completed in Canada
should be acceptable to both the United States FDA and the Regulatory Agencies
of the EU.
Clinical Studies
The Italian Initiative
To date the Company has not performed any human clinical studies in
Italy. In late 1992, the Italian Ministry of Health suspended the clinical use
of ozone until such time as sufficient scientific evidence was available to
support its use as a human therapeutic treatment. The Italian Ministry of Health
designated the Italian Scientific Society for Ozone-Oxygen Therapy in Bergamo,
Italy ("ISSOT") as the agency responsible for selecting those treatment
protocols utilizing ozone as worthy of investigation and to provide those
protocols to the Italian Ministry of Health for review and approval. By letter
agreement dated March 23, 1993, the Company and ISSOT entered into a
collaborative arrangement to research and examine the efficacy of the Medizone
Technology in the treatment of various blood-related human diseases. The
research is to be supervised by ISSOT in Italy under the direction of a research
group assembled by the Italian Ministry of Health. The research is to be
conducted in accordance with protocols that will meet EU Standards for human
clinical trials (to be furnished by the Company) at university-based hospitals,
which will enter into agreements with the Company on a site-by-site basis. The
ISSOT letter agreement requires the Company to furnish ozone-generating
instruments for use in the trials and to pay for laboratory tests performed by
each testing institution that are outside the scope of the normal realm of
clinical analyses performed by the testing institutions. There can be no
assurance that any of the data generated from the ISSOT research will be
permitted to be utilized in connection with the Company efforts to re-open the
FDA IND (see "Governmental Regulation").
While the ethics committees at certain university hospitals have stated
their approval for the Company to conduct Phase II trials, they would require
the Company to have either completed a large animal study and Phase I trials or
to obtain a waiver of these requirements. The Company has never performed a
large animal study or published Phase I clinical trial and does not possess the
necessary data with respect to its ozone therapy to commence Phase II study.
However, there exists a broad use and understanding of ozone therapy throughout
Europe and there have been numerous scientific articles published in European
medical journals describing the use of ozone on humans.
Instrument Development
The Company has entered into an agreement with Biozone Corporation
("Biozone") under which Biozone was granted worldwide manufacturing rights for
Medizone Ozone Generating Equipment. Medizone has exclusive worldwide marketing
rights for Biozone manufactured equipment intended for scientific research and
medical applications, to be marketed under the Medizone label. Biozone expects
to relocate to California in the future, so the manufacturing facility can be
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located near Medizone's corporate headquarters. Under the agreement, Biozone
retains the right to market its other industrial applications, such as water
treatment plants. Once Medizone has obtained regulatory approvals for its
technology and protocols and is in production mode, Biozone will phase out its
other business to concentrate on its work with Medizone. As consideration under
the licensing agreement the Company issued 100,000 shares of restricted stock to
Biozone in 1998.
International Activities
Medizone Canada Limited
To maximize research opportunities and the potential market for its
products, the Company intends to establish subsidiary or affiliated corporations
in other countries. The organization of these subsidiaries may initially require
the Company to incur significant expenses; thereafter, it is intended that the
subsidiaries would be responsible for organizing research programs and
generating possible sources of financing, from which the Company would benefit
directly or indirectly. It is anticipated that the Company would also enter into
license agreements with all subsidiary companies.
In June 1998, the Company sold its majority interest in Medizone Canada
Limited, a Utah corporation ("MCL") for $125,000 cash in a private transaction.
The Company retained ownership of all of the issued and outstanding stock of MCL
Medizone Canada, Ltd., a Canadian corporation ("MedCan"). MedCan was a
participant in the Canadian Blood Forces Program's SIV Study.
The Canadian government requires that research accepted under the
auspices of Health Canada must be performed by a Canadian Company. Future
research in Canada will be pursued through MedCan. Future staffing of MedCan
will be with Canadian citizens and MedCan will be operated from Canada. The
Company also intends to establish a non-profit corporation to be owned by
MedCan. The future business of the non-profit will be to aid the economically
underdeveloped third world countries in the acquisition of Medizone equipment,
training of doctors, and funding of programs for hepatitis and aids, at greatly
discounted prices in those countries.
Medizone New Zealand Limited
On June 22, 1995, the Company entered into a series of contracts that
resulted in the formation of a joint venture subsidiary incorporated in New
Zealand, Medizone New Zealand Limited ("MNZ"). MNZ is owned equally by the
Company and Solwin Investments Limited ("Solwin"), a New Zealand corporation,
which is an affiliate of Richard G. Soloman ("Soloman"), a former director of
the Company. MNZ is a research and development stage company formed to obtain
regulatory approval for the distribution of the Company's patented technology in
New Zealand, Australia, South East Asia and the South Pacific Islands.
Under these agreements the Company purchased 100% of MNZ from Soloman
and sold 50% of MNZ to Solwin for $150,000, of which $50,000 was loaned by the
Company to MNZ on a demand basis and repaid on October 26, 1995. On October 26,
1995, the Company loaned MNZ $50,000 on a demand basis, which has not been
repaid as of the date of this report. The Company and MNZ also entered into a
Licensing Agreement (the "Licensing Agreement") and a Managing Agent Agreement
(the "Managing Agent Agreement").
Under the Licensing Agreement, the Company granted an exclusive license
to MNZ for Patent No. 1 and Patent No. 2 and the Company's trademark in New
Zealand. MNZ has agreed to apply for corresponding patent protection for these
patents in New Zealand and to use its best effort to exploit the rights granted
in the Licensing Agreement. The Licensing Agreement will terminate on the
expiration date of the last patent obtained in New Zealand, or, if no patents
are obtained, on June 22, 2010. The Company will receive a guaranteed minimum
royalty, in an amount to be agreed to by the Company and MNZ, commencing in the
third year after all necessary regulatory approvals requisite to the license,
use or distribution of the Company's proprietary technology have been obtained
in New Zealand. If the Company and MNZ are unable to agree upon the amount of
the guaranteed minimum royalty, the Company may terminate the Licensing
Agreement. Commencing on the first sale to a user by MNZ, the Company will
receive a sales royalty of MNZ's gross annual sales under the Licensing
Agreement.
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Under the Managing Agent Agreement, MNZ will act as the Company's agent
to find licensees of the Medizone Technology in Australia, New Zealand, the
South Pacific Islands and Southeast Asia (including the Philippines, Indonesia
and Vietnam). Licensing fees will be divided between the Company and MNZ on a
sliding scale as set forth below:
<TABLE>
<CAPTION>
The Company MNZ
<S> <C> <C>
Initial license 50% 50%
Subsequent license
fees up to $500,000 50% 50%
Subsequent license
fees between $500,000
and $750,000 75% 25%
Subsequent license
fees in excess of
$750,000 85% 15%
</TABLE>
MNZ and the Company will also divide any net royalties paid to the
Company under any license entered into pursuant to the Managing Agent Agreement,
with MNZ receiving 10% and the Company receiving 90% of the net royalties under
those licenses.
The Managing Agent Agreement expires on the termination or expiration
of the last of the licenses obtained under the agreement, subject to earlier
termination by the Company under certain circumstances.
Competition
The market in which the Company intends to do business is extremely
competitive. The Company is aware of several companies that have commenced
research into the use of ozone as a virucide in the treatment of HIV and other
diseases, or that have announced the intention to do so. Other companies,
foundations, research laboratories or institutions may also be conducting
similar investigations into the use of ozone as a virucide or as a decontaminant
for blood or blood products.
Employees
As of December 31, 1999, the Company had four full time employees.
Status of the Company's Research
The Company has entered into a research agreement with a multinational
research partner interested in the possibility of viral deactivation of serum
products by using ozone. Serum products are used to make a media base that is
then used in the manufacture of vaccines for humans and animals. Under the terms
of the agreement, if the research proves successful, Medizone will enter into a
license agreement for the use of the technology in the viral deactivation of
commercial vats of serum product.
A director, Dr. William Hitt, commenced a human pilot trial into the
deactivation of hepatitis C in 1998. Using Medizone ozone generating equipment
constructed by Biozone, in the course of his regular medical practice. Dr. Hitt
operates the William Hitt Center in Tijuana, Mexico. The initial results of the
trial have shown significant reductions in viral load and the normalization of
previously elevated liver enzyme levels as measured by SGOT and SGPT tests. The
therapy consists of an outpatient daily treatment protocol averaging 30 days in
duration. Although the study was done in Mexico, the laboratory tests were
evaluated at FDA reference laboratories in the United States to assure
statistical reliability. The pilot trial was not conducted as a double blind
study, or under conditions that would allow for peer review, journal published
research as required by the FDA. However, the Company is satisfied that the
trial served as a successful proof of concept human trial for the Company's
proposed hepatitis protocols.
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Risk Factors
The Company's business is in the development stage and is subject to a
number of risks, including, but not limited to the following:
Development Stage Company/Net Losses
The Company is in the development stage and has not generated any
revenues from operations. No assurance can be given that its business activities
will ever generate revenues. As indicated in the Company's financial statements,
the Company has experienced substantial losses throughout its history. Losses
can be expected to continue for the foreseeable future.
Need for Additional Financing
The Company has funded its development activities to date primarily
from the sale of its common stock. The Company will require substantial
additional capital, which will most likely be obtained through sales of its
common stock or other securities, to continue the research program outlined
above, pay its administrative and operating expenses, meet its filing and
disclosure obligations as a public company, and repay certain outstanding
indebtedness. Cash operating reserves on hand as of March 23, 2000 should
support operations for eight months. No assurances can be given that the Company
will be able to obtain sufficient additional capital for it to continue its
research program, or that any additional financing will be sufficient to satisfy
the Company's administrative and operating expenses for any significant period
of time.
Production Identification and Development
The Company believes that its proprietary technology offers benefits
that are not currently found in existing purification, disinfection and
sterilization systems. To date, the Company has not brought to market any
products incorporating the technology. The Company has conducted only
preliminary clinical, engineering and other tests to determine the feasibility
of products that could incorporate the technology, although it believes that the
technology may be incorporated into other products and devices. The Company has
conducted proof-of-concept tests of the technology, but there can be no
assurance that the Company will be able to develop or market any products, or
that the Company's technology may be successfully incorporated into any existing
or future products.
Early Stage of Development; Technological Uncertainty
The Company is at an early stage of development. The Company has not
received any required governmental approvals for the use or application of the
Medizone Technology in any medical or other clinical product or device, and it
has not yet realized any revenues from the sale or license of any products.
Product revenues may not be realized from the sale or licensing of any products
(if they are identified and developed) for several years, if at all. Many of the
products and applications the Company is currently evaluating will require
significant research and development efforts prior to any commercial use, and
those additional research and development efforts may include pre-clinical and
clinical testing, as well as a lengthy regulatory approval process. There can be
no assurance the Company's research and development efforts will be successful,
that the Company's potential products will prove to be safe and effective in any
required clinical trial or other governmental tests, or that any commercially
successful products will ultimately be developed by the Company.
Potential Dependence on Strategic Alliances
The Company's strategy for the identification, development, testing,
manufacture, marketing and commercialization of its technology includes entering
into various collaborations with corporate partners, licensors, licensees and
others. There can be no assurance that the Company will be able to negotiate
strategic alliances on acceptable terms, if at all, or that these collaborative
arrangements will be successful. To the extent the Company chooses not, or is
not able, to establish such arrangements, it could experience increased capital
requirements as a result of its undertaking such activities at its own risk and
expense. In addition, the Company may encounter significant delays in
introducing products or product applications currently under development into
the marketplace
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or find that the development, manufacture or sale of its proposed products are
adversely affected by the absence of such collaborative agreements.
Under typical collaborative relationships, the collaborative partners
have the right to pursue parallel development of other products that may compete
with the products of the other collaborative partner, and to terminate the
agreements without significant penalty under certain conditions. Any parallel
development by a collaborative partner of the Company of competing products, or
the failure by a collaborative partner to devote sufficient resources to the
development and commercialization of the Company's products, could have a
material adverse effect on the Company's business, financial condition or
results of operations.
The Company's success may depend upon, among other things, the skills,
experience and efforts of the Company's collaborative partners, employees who
are responsible for the collaborative project, such partners' commitment to the
collaborative arrangement, and the financial condition of such partners, all of
which are beyond the control of the Company. If one or more of the Company's
collaborative partners defaulted on their obligations under their collaborative
arrangements, the Company could be forced to engage in litigation to enforce
those obligations (which could be time consuming and costly) or seek to enter
into agreements with other parties upon similar terms.
Future Capital Needs; Uncertainty of Additional Funding
The identification, development and commercialization of the Company's
products and technology will require a commitment of substantial funds to
conduct research and development activities, including possible pre-clinical and
clinical studies, to create and expand distribution and marketing capabilities
and to acquire and expand manufacturing capacity. The Company's actual capital
requirements will depend on many factors, including but not limited to, the
costs and timing of the Company's research and development activities, the
number and type of clinical or other tests the Company may be required to
conduct in seeking approval of its products from governmental or other agencies,
the success of the Company's development efforts, the cost and timing of
establishing or expanding the Company's sales and marketing and/or manufacturing
activities, the extent to which the Company's products (if any) gain market
acceptance, the Company's ability to establish and maintain collaborative
relationships, competing technological and market developments, the progress of
the Company's commercialization efforts and the commercialization efforts of the
Company's marketing partners, the costs involved in preparing, filing,
prosecuting, maintaining and enforcing and defending patent claims and other
intellectual property rights, developments related to regulatory issues, and
other factors.
To satisfy its capital requirements, the Company may seek to raise
funds through public or private financings, collaborative relationships or other
arrangements. Additional equity financing may be dilutive to stockholders, and
debt financing, if available, may involve significant restrictive covenants.
Collaborative arrangements, if necessary to raise additional funds, may require
the Company to relinquish its rights to certain of its technologies, products or
marketing territories. The Company's failure to raise capital when needed could
also have a material adverse effect on the Company's business, financial
condition and results of operations. There can be no assurance that any such
financing, if required, will be available on terms satisfactory to the Company,
if at all.
Governmental Regulation
The research, development, manufacture and marketing of the Company's
products which constitute medical devices or products will be extensively
regulated by a number of governmental agencies, including the United States Food
& Drug Administration ("FDA"). The FDA requires governmental clearance of all
medical devices and drugs before they can be marketed in the United States.
Similar approvals are required from other regulatory bodies in virtually every
foreign country. The regulatory processes established by these government
agencies are lengthy, expensive, and uncertain and may require extensive and
expensive clinical trials. There can be no assurance that any future products
developed by the Company and which are subject to the FDA's authority will prove
to be safe and effective and meet all of the applicable regulatory requirements
necessary to be marketed. The results the Company obtains from its testing
activities could be susceptible to varied interpretations, which could delay,
limit or prevent required regulatory approvals. In addition, the Company may
encounter delays or denials of approval based on a number of factors, including
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future legislation, administrative action or changes in FDA policy made during
the period of product development and FDA regulatory review. The Company may
encounter similar delays in foreign countries. Furthermore, approval may entail
ongoing requirements for, among other things, post-marketing studies. Even if a
product developer obtains regulatory approval, a marketed product, its
manufacturer and its manufacturing facility are subject to on-going regulation
and inspections. Discovery of previously unknown problems with a product,
manufacturer or facility could result in FDA sanctions, restrictions on a
product or manufacturer, or an order to withdraw and/or recall a specific
product from the market. There can also be no assurance that changes in the
legal or regulatory framework or other subsequent developments will not result
in limitation, suspension or revocation of regulatory approvals granted to the
Company. Any such events, were they to occur, could have a material adverse
effect on the Company's business, financial condition and results of operations.
The Company may also be required to comply with FDA regulations for
manufacturing practices, which mandate procedures for extensive control and
documentation of product design, control and validation of the manufacturing
process and overall product quality. Foreign regulatory agencies have similar
manufacturing standards. Any third parties manufacturing the Company's products
or supplying materials or components for such products may also be subject to
these manufacturing practices and mandatory procedures. If the Company, its
management or its third party manufacturers fail to comply with applicable
regulations regarding these manufacturing practices, it could be subject to a
number of sanctions, including fines, injunctions, civil penalties, delays,
suspensions or withdrawals of market approval, seizures or recalls of product,
operating restrictions and, in some cases, criminal prosecutions.
The Company's products may also be subject to regulation, inspection
and licensing by other governmental agencies, including the Environmental
Protection Agency ("EPA"), state agencies similar to the FDA and EPA and the
Occupational Health and Safety Administration ("OSHA"). In addition, if the
Company engages in contract sterilization services, the Company's products and
operations may be subject to the infection control or other requirements of the
Joint Commission on Accreditation of Health Care Organizations, the Center for
Disease Control, the Association for Advancement of Medical Instrumentation and
other federal and state agencies that have established or maintain testing
methods or sterilization process monitoring.
Uncertainty Associated with Clinical Trials and Other Tests
Certain of the Company's products may constitute medical devices within
the meaning of the Food, Drug and Cosmetic Act (the "FDA Act") and, therefore,
may be subject to the FDA's regulations governing medical devices. Products
regulated as medical devices may not be commercially distributed in the United
States unless they have been cleared or approved by the FDA, or unless they are
otherwise exempted from the FDA's regulations. Currently, there are two methods
for obtaining FDA approval or clearance of medical devices. Devices deemed to
pose less risk are placed in class I (general controls) or class II (general and
special controls) and qualify for "510(k) notification," a procedure under
section 510(k) of the FDA Act. In order for a device to qualify under that
procedure, the manufacturer must, among other things, establish that the product
is substantially equivalent in intended use, safety and effectiveness to another
legally marketed class I or class II device or to a "pre-amendment" class III
device for which the FDA has not called for preliminary market approval ("PMA").
Medical class III is the class reserved for devices deemed by the FDA to pose
the greatest risk. Manufacturers of class III devices must file a PMA under
section 515 of the FDA Act. PMA applications generally require a much more
complex submission than a 510(k) notification and typically require a showing
that the device is safe and effective based on extensive and costly clinical and
other testing. There can be no assurance that any product developed by the
Company which is deemed to be a medical device for FDA Act purposes will qualify
for approval under the 510(k) notification process or that any such products
will be deemed to be safe and effective if required to be qualified under a PMA.
The time required to obtain FDA approval is uncertain, and frequently
takes several years or more, if approval is ever granted. There can be no
assurance that any future products developed or identified by the Company alone
or in conjunction with others will prove to be safe and efficacious in any
required clinical trials, or that they will meet the applicable regulatory
requirements necessary for their marketing, including the receipt of a marketing
clearance, should such be required. Further, if regulatory approval is granted
that approval would generally be limited to the uses for which the product has
been demonstrated through clinical studies and other means to be safe and
effective. Furthermore, approval may entail ongoing requirements for, among
other things, post-marketing studies. Even if regulatory approval is obtained a
marketed product, its manufacturer and its manufacturing facilities and
pertinent operations are subject to extensive regulation and periodic
8
<PAGE>
inspections. The regulatory requirements pertinent to medical device
manufacturing and related activities are stringently applied and enforced by the
FDA and similar governmental agencies in other countries.
If the Company is required to conduct clinical or other testing or
trials of its products, any such testing will need to be made in compliance with
regulations promulgated by the FDA under the authority granted it under the FDA
Act. In other countries, governmental agencies similar to the FDA also regulate
the sale of medical devices and products, generally in a manner similar to the
FDA's regulation of those products. Sales of any products to Europe also require
a "CE" mark, which shows that the product has been manufactured in accordance
with required standards. The Company's sterilization technology has not been
approved for use in connection with or as part of any device, and there can be
no assurance that the Company will not encounter problems in the conduct of any
clinical trials or tests it is required to complete which will cause the FDA, or
any other regulatory agencies to delay or suspend the tests or otherwise not
approve the sale of the Company's products. If any of the Company's products
under development are not shown to be safe and effective in any required
clinical trials, the resulting delays in developing other products or conducting
related pre-clinical testing and clinical trials, as well as the need for
financing to complete any such testing and trials, could have a material adverse
effect on the Company's business, financial condition and results of operations.
No Manufacturing Capability
The Company has no manufacturing capability or capacity to produce any
products utilizing its sterilization technology, including any products to be
used in any required clinical or other tests. The Company initially intends to
develop relationships with other companies to manufacture those components
and/or products, with the Company being primarily in the role of specification
developer and final assembly manufacturer for selected products only. The two
products currently being developed by the Company have never been manufactured
on a commercial scale and there can be no assurance that such products can be
manufactured at a cost or in quantities necessary to make them commercially
viable. Any delay in availability of products may result in a delay in the
submission of products for any required regulatory approval or market
introduction, subsequent sales of such products, which could have a material
adverse effect on the Company's and business, financial condition, or results of
operations. The Company's manufacturing processes may be labor intensive and, if
so, significant increases in production volume would likely require changes in
both product and process design in order to facilitate increased automation of
the Company's then-current production processes. There can be no assurance that
any such changes in products or processes or efforts to automate all or any
portion of the Company's manufacturing processes would be successful, or that
manufacturing or quality problems will not arise as the Company initiates
production of any products it might develop.
In addition, some or all of the Company's potential products, or
products in which the Company's sterilization technology may be incorporated,
may be required to be manufactured in accordance with current FDA or other
governmental agency manufacturing regulations. If the manufacturing facilities
cannot pass a plant inspection by the FDA, the manufacturer's ability to
manufacture the products will be adversely affected. There can be no assurance
the Company can successfully acquire manufacturing capacity on a profitable
basis, or contract with another party on terms acceptable to the Company, if at
all.
No Sales or Marketing Capability
The Company has no experience in sales, marketing or distribution. To
market any of its products directly, the Company would be required to develop a
marketing and sales force with technical expertise and with supporting
distribution capability. Alternatively, the Company may obtain the assistance of
other companies with an established distribution and sales force. To this end,
the Company would be required to enter into agreements with such parties
regarding the use and maintenance of such distribution systems and sales forces.
There can be no assurance the Company will be able to establish sales and
distribution capabilities, or that it will be successful in gaining market
acceptance for its products through the use of the efforts of third parties.
There can be no assurance the Company will be able to recruit, train
and maintain successfully any such sales and marketing personnel, or that the
efforts of such personnel will be successful.
9
<PAGE>
Uncertainty of Protection of Patents or Proprietary Rights
The Company's success will depend, in large part, on its ability to
obtain and enforce patents, maintain its trade secrets and operate without
infringing on the proprietary rights of others, both in the United States and in
other countries. The patent positions of companies can be uncertain to some
extent and involve complex legal and factual questions, and, therefore, the
scope and enforceability of claims allowed in patents are not systematically
predictable with absolute accuracy. The Company's license rights depend in part
upon the breadth and scope of protection provided by the patents and the
validity of the patents. Any failure to maintain the issued patents could
adversely affect the Company's business. The Company intends to file additional
patent applications (both United States and foreign), when appropriate, relating
to its technologies, improvements to its technologies and for specific products
it develops. There can be no assurance that any issued patents or pending patent
applications of the Company will not be challenged, invalidated or circumvented.
There can also be no assurance that the rights granted thereunder will provide
proprietary protection or competitive advantages to the Company.
The commercial success of the Company will also depend, in part, on the
Company not infringing patents issued to others and not breaching any technology
licenses upon which the Company's products and services are based. It is
uncertain whether any third party patents will require the Company to alter its
products or processes, obtain licenses or cease certain activities. In addition,
if patents have been issued to others which contain competitive or conflicting
claims and such claims are ultimately determined to be valid, the Company may be
required to obtain licenses to those patents or to develop or obtain alternative
technology. If any licenses are required, there can be no assurance the Company
will be able to obtain any such licenses on commercially favorable terms, if at
all. The Company's breach of an existing license or its failure to obtain a
license to any technology that it may require in order to commercialize its
products may have a material adverse impact on the Company's business, results
of operations and financial condition. Further, litigation, which could result
in substantial costs to the Company, may also be necessary to enforce patents
licensed or issued to the Company or to determine the scope or validity of third
party proprietary rights. If competitors of the Company prepare and file patent
applications in the United States that claim technology also claimed by the
Company, the Company may have to participate in interference proceedings
declared by the U.S. Patent and Trademark Office to determine priority of
invention, which could result in substantial cost to the Company, even if the
eventual outcome is favorable to the Company. An adverse outcome could subject
the Company to significant liabilities to third-parties, require disputed rights
to be licensed from third-parties or require the Company to cease using such
technology.
The Company also relies on secrecy to protect portions of its
technology for which patent protection has not yet been pursued or which is not
believed to be appropriate or obtainable in addition to any information of a
confidential and proprietary nature relating to the Company, including but not
limited to its know-how, trade secrets, methods of operation, names and
information relating to the Company's vendors or suppliers and customer names
and addresses. This technology includes technology that the Company acquired
from two parties in connection with, but separate from, the patented technology
from Biozone, a portion of which the Company has acquired and a portion of which
it has obtained a license to use. There can be no assurance that the Company's
undivided ownership and/or license rights in such technology are enforceable.
The Company intends to protect this unpatentable and unpatented
proprietary technology and processes, in addition to other confidential and
proprietary information in part, by confidentiality agreements with its
employees, collaborative partners, consultants and certain contractors. There
can be no assurance that these agreements will not be breached, that the Company
will have adequate remedies for any breach, whether the Company's trade secrets
and other confidential and proprietary information will not otherwise become
known or be independently discovered or reverse-engineered by competitors.
Intense Competition; Rapid Technological Change
There can be no assurance the Company's technology will have advantages
over those of its competitors, which will be significant enough to cause users
to adopt its use. The products in which the Company's technology may be
incorporated will compete with products currently marketed, and competition from
such products is expected to increase.
10
<PAGE>
Most of the companies currently producing products or using techniques
have significantly greater financial resources and expertise in research and
development, marketing, manufacturing, pre-clinical and clinical testing,
obtaining regulatory approvals and marketing than the Company. Smaller companies
may also prove to be significant competitors, particularly through collaborative
arrangements with large third parties. Academic institutions, governmental
agencies and public and private research organizations also conduct research,
seek patent protection and establish collaborative arrangements for product and
clinical development and marketing. Many of these competitors have products or
techniques approved or in development and operate large, well-funded research
and development programs. Moreover, these companies and institutions may be in
the process of developing technology that could be developed more quickly or
ultimately proved safer or more effective than the Company's technology.
The Company faces competition based on product efficacy, safety, the
timing and scope of regulatory approvals, availability of supply, marketing and
sales capability, reimbursement coverage, price and patent position. There can
be no assurance the Company's competitors will not develop more effective or
more affordable products, or achieve earlier patent protection or product
commercialization than the Company.
Product Liability
The testing, marketing and sale of medical or clinical products and
other products that may utilize the Company's technology involves unavoidable
risks. The use of any of the Company's potential products in clinical or other
tests or as a result of the sale of its products, or the use of its technology
in products, may expose the Company to potential liability resulting from the
use of such products. Such liability may result from claims made directly from
consumers or by regulatory agencies, companies or others selling such products.
The Company currently has no clinical trial or product liability insurance
coverage, although it anticipates obtaining and maintaining appropriate
insurance coverage as clinical or other development of its product candidates
progresses and if and when its products are ready to be commercialized. There
can be no assurance the Company will be able to obtain such insurance or, if it
obtains such insurance, that such insurance can be acquired at a reasonable cost
or in sufficient amounts to protect the Company against such liability. The
obligation to pay any product liability claim in excess of whatever insurance
the Company is able to acquire, or the recall of any of its products (or the
products incorporating the Company's technology) could have a material adverse
effect on the Company's business, financial condition and future prospects.
Hazardous or Toxic Materials
The Company's research and development activities, and the application
of the Company's technology, may involve the controlled use of materials,
substances or electro-magnetic radiation which may, if used or employed
improperly, prove hazardous. The Company believes, however, that its technology
employs such potentially hazardous or toxic materials and substances in a manner
that minimizes their adverse effects. Further, where such hazards are employed,
the Company intends to utilize appropriate detection equipment and take
appropriate countermeasures in design, or in the test lab environment.
Need to Attract and Retain Key Employees and Consultants
The Company is dependent on the principal members of its scientific and
management staff. In addition, the Company anticipates that it will rely upon
consultants and advisors to assist it in formulating its research and
development strategies and operations. Retaining and attracting qualified
personnel, consultants and advisors will be critical to the Company's success.
In order to pursue its product development and marketing plans, the Company will
be required to hire additional qualified scientific personnel, as well as
personnel with expertise in clinical testing, governmental regulation,
manufacturing and marketing. Expansion of product development and marketing are
also expected to require the addition of management personnel and the
development of additional expertise by existing management personnel. The
Company faces competition for qualified individuals from numerous medical and
clinical companies, universities and other research institutions. There can be
no assurance the Company will be able to attract and retain such individuals on
acceptable terms, when needed, and to the degree required.
The Company anticipates that any clinical development or other approval
tests in which it participates will be augmented by agreements with universities
and/or medical institutions or other personnel. It is likely that the Company's
11
<PAGE>
academic collaborators will not be employees of the Company. As a result, the
Company will have limited control over their activities and can expect that only
limited amounts of their time will be dedicated to the Company's activities. The
Company's academic collaborators may have relationships with other commercial
entities, some of which could compete with the Company.
Uncertainty of Health Care Reform Measures and Third Party Reimbursement
The Company currently anticipates that one or more of its potential
products may constitute medical products. Recently, a series of legislative and
regulatory proposals has been initiated with the aim of changing the United
States health care system. While the Company cannot predict whether any such
legislative or regulatory proposals will be adopted, or the effect such
proposals may have on its business if they are adopted, the pendency of such
proposals could have a material adverse effect on the Company's ability to raise
capital, and the adoption of such proposals could have a material adverse effect
on the Company's business, financial condition and results of operations.
Furthermore, the Company's ability to develop, identify or commercialize its
potential product portfolio (which includes medical and clinical applications)
may be adversely affected to the extent that such proposals have a material
adverse effect on the business, financial condition and profitability of other
companies that are prospective collaborators for certain of the Company's
proposed products.
Forward-looking Statements
Certain statements in this report constitute "forward-looking
statements" within the meaning of the rules and regulations promulgated by the
Securities and Exchange Commission. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors which may cause the
actual results, performance or achievements of the Company, or industry results,
to be materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. These risks,
uncertainties and other factors include, among other things, the Company's
unprofitability and the continuing uncertainty of its profitability, the
Company's ability to develop and introduce new products, the Company's lack of
sales, marketing and distribution experience and anticipated dependence on third
parties for such matters, the risks associated with obtaining governmental
approval of the Company's products, the highly competitive industry in which the
Company intends to operate and the rapid pace of technological change within
those industries, the uncertainty of patent and proprietary technology
protection and the Company's reliance on such patent and proprietary technology
(including reliance on technology licensed from third parties), changes in or
failure to comply with governmental regulation, the uncertainty of third party
reimbursement for the Company's products, the Company's dependence on key
employees, general economic and business conditions and other factors referenced
above.
Item 2. Properties
The Company's offices are located at 144 Buena Vista Ave., Stinson
Beach, California. The offices are located temporarily in the home of the
Company's CEO, Edwin Marshall. When financial resources permit, the Company
intends to remain in the San Francisco Bay Area and lease office space that will
allow for additional staffing. The Company pays $100 a month for an adjacent
storage area for the Company's archives and pays or reimburses all telephone and
related expenses incurred by or for the Company.
Item 3. Legal Proceedings
In November 1992, the Company consented to the entry of a final
judgment of permanent injunction (SEC v. Medizone International, Inc., Civil
Action 93-2761, D.D.C.), pursuant to which the Company was permanently enjoined
from failing to timely file the reports required to be filed pursuant to the
Securities Exchange Act of 1934. The Company's report for the year ended
December 31, 1998 was filed late. There is no assurance that the failure of the
Company to file this, or any future report in a timely manner will not lead to
additional sanctions or actions against the Company by the SEC or others.
On December 3, 1999, the Company filed a complaint in the Third
Judicial District Court of Salt Lake County, Utah (Civil No. 990912073) against
its former Chief Financial Officer, Arthur P. Bergeron. Among other things, the
12
<PAGE>
complaint filed by the Company sought a declaration from the court regarding the
enforceability of Mr. Bergeron's employment contract, the right of the Company
to terminate his employment and other relief. The Company and Mr. Bergeron have
agreed upon a settlement, under the terms of which the Company agreed to
withdraw its complaint with prejudice and Mr. Bergeron waived any further claim
for wages or other compensation under his employment agreement. In addition, Mr.
Bergeron consented to the cancellation of 2,000,000 shares of common stock
issued to him during the tenure of the Company's former President and CEO,
Joseph R. Latino. The settlement agreement has not yet been finalized, but the
Company anticipates that the final agreement will be executed by April 30, 2000.
Following the takeover and management change of June 12, 1997, new
management learned that there had been serious irregularities and possible fraud
perpetrated upon the Company by the former President & CEO, Mr. Latino. As the
seriousness of those past events became more evident, management presented the
information it had gathered to the New York District Attorney's Office. That
office commenced a criminal investigation that ultimately resulted in charges
being brought against Mr. Latino. On January 25, 2000, Mr. Latino was sentenced
to serve 1.5 to 4.5 years and pay restitution in the amount of $415,869 to
Medizone under a plea bargain that dropped all felony charges except for one
count of Grand Larceny in the Second Degree.
Part II
Item 5. Market for Registrant's Common Equity and Related Stockholder Matters
The Company's shares are traded in the over-the-counter market, with
price quotes listed on the OTC Electronic Bulletin Board under the trading
symbol "MZEI," and in the "pink sheets" published by the National Quotation
Bureau.
The following table summarizes data from the National Quotation Bureau,
indicating the high and low bid prices for a share of the Company's common stock
during each of the four calendar quarters of fiscal 1998 and 1999. These prices
reflect interdealer prices without retail markup, markdown or commission, are
not necessarily representative of actual transactions, or of the value of the
Company's securities, and are, in all likelihood, not based upon any recognized
criteria of securities valuation as used in the investment banking community.
<TABLE>
<CAPTION>
Bid Price
Calendar Period High Low
------------------- ------------------------
<S> <C> <C> <C> <C>
1999 First Quarter .095 .065
Second Quarter .17 .065
Third Quarter .195 .125
Fourth Quarter .13 .08
1998 First Quarter .09 .045
Second Quarter .06 .037
Third Quarter .095 .035
Fourth Quarter .102 .047
</TABLE>
As of March 21, 2000, there were approximately 3839 holders of record
of the Company's common stock, and approximately 4511 beneficial owners.
The Company has never paid cash dividends on its common stock. Payment
of cash dividends is subject to the discretion of the Board of Directors and is
dependent upon various factors, including the Company's earnings, capital needs
and general financial condition. To date the Company has had no revenues or
earnings. The Company does not believe that it has any immediate prospect of
earnings. However, the Company anticipates that in the foreseeable future, it
will follow a policy of retaining earnings, if any, to finance research and
development.
13
<PAGE>
Item 6. Management's Discussion and Analysis or Plan of Operation
Results of Operations
From its inception in January 1986, the Company has been a development
stage company primarily engaged in research into the medical uses of ozone. The
Company has not generated, and cannot predict when or if it will generate,
revenues or sufficient cash flow to fund its continuing operations.
The Company has had no sales. In 1998, the Company had revenues of
$125,000 from the sale of a subsidiary. The Company had no revenues in 1999. In
January 2000, the Company received payment of $415,869 under an order of
restitution entered against its former President and CEO.
There were $75,000 in research and development expenditures, including
work performed by independent contractors in 1999, compared to $13,218 for
research and development in 1998. Since inception the Company has spent
$2,407,853 for research and development.
General and administrative expenses were $198,308 in 1999, compared to
$562,729 in 1998. These expenses include professional fees, payroll, insurance
costs and travel expenses.
Notes payable in 1999 totaled $280,491 in 1999 and 1998.
Liquidity and Capital Resources
At December 31, 1999, the Company had a working capital deficiency of
$1,058,028 and a stockholders' deficiency of $1,052,361 compared to a working
capital deficiency of $1,031,586 and a stockholders' deficiency of $1,023,974 in
1998.
The Company will continue to require additional funding to enable it to
fund research necessary to make the appropriate regulatory application and
continue operations. It is expected that these funds will be generated by the
sale of the Company's securities.
Item 7. Financial Statements and Supplementary Data
The financial statements of the Company are attached to this report
commencing on page F-1.
Part III
Item 9. Directors and Executive Officers, Promoters and Control Persons;
Compliance with Section 16(a) of the Exchange Act
The following table contains information concerning the directors and
executive officers of the Company as of March 23, 2000.
Name Age Position
Edwin G. Marshall 57 Chairman of the Board, CEO
Gerard V. Sunnen 57 Director, President
William M. Hitt 73 Director
Jill C. Marshall 48 Chief Operating Officer, Corporate Secretary
Kevin R. Andersen 48 Chief Financial Officer
Edwin G. Marshall became Chairman of the Board & Chief Executive
Officer in April 1998 and has been with the Company since June 1997. Mr.
Marshall attended Santa Rosa Junior College and the College of Marin, studying
fire science and business administration. From 1964 to 1978, Mr. Marshall worked
14
<PAGE>
in the fire service in a city with a major chemical industrial complex, leaving
with the rank of Captain. A private investor since 1973, he went to work in the
real estate business in 1978. From 1978 until 1995, Mr. Marshall pursued various
business interests in real estate brokerage, a vacuum forming business in the
plastics industry, an industrial computer controls company, and an automobile
and truck dealership. Since 1992 he has concentrated on his own investments, and
since 1997 devoted substantially all of his time to management responsibilities
with Medizone.
Gerard V. Sunnen, M.D. became a Director of the Company in June 1997,
Director of Research in 1997 and President in 1998. He graduated from Rutgers
University in 1963 and from the medical school of the State University of New
York, Downstate, in 1967. Dr. Sunnen has practiced psychiatric medicine since
his graduation from medical school and has taught clinical psychiatry at New
York University Medical Center since 1977, where he is now an Associate Clinical
Professor of Psychiatry. He is currently a consultant to several organizations
and companies, including the Institute for Behavior Therapy and the Training
Institute for Mental Health Practitioners in New York. He is a member of the
American Psychiatric Association, the American Society of Clinical Hypnosis, the
International Association of Emergency Psychiatry, of which he is Honorary
President, and the World Psychiatric Association, where he is currently Vice
President of the Section for Emergency Psychiatry. He received the Chevalier de
l'Ordre du Merite from the French government in 1990 for his work in assisting
members of the French community in New York. Dr. Sunnen has written and lectured
extensively on psychiatric medicine and medical hypnosis. Dr. Sunnen has also
written on the medical applications of ozone.
William M. Hitt became a Director of the Company in June 1997. He
received a Bachelor's of Science degree from the University of Denver in 1946
and a Ph.D. from Colorado A&M University in 1948. He received a medical degree
from the University of Colorado in 1952 and did post-medical school studies at
Duke University and Washington University School of Medicine. Dr. Hitt has
taught and conducted research at several institutions in the United States and
Mexico, culminating with his work at the World Health Organization in Mexico
City from 1989 to 1994. He was the recipient of the Eli Lily Award from the
National Institute of Health in 1953, the Leovenhoek Award in 1960, the
Cientifico Destacado in 1990 and 1992 and the Bioethics International Award of
Merit in 1993. Dr. Hitt was a member of the Board of Directors of Physicians
Against Nuclear War, which organization was awarded the Nobel Peace Prize in
1985. Dr. Hitt is currently the Director of the William Hitt Center, which
conducts clinical immunology and addiction recovery programs, has operated since
1986 and now has seven locations in Central and South America, with headquarters
in Tijuana, Mexico.
Jill C. Marshall, N.D., has been the Chief Operating Officer and
Corporate Secretary of Medizone since April 1998. Dr. Marshall is the recipient
of a Doctor of Naturopathy degree from The Southern College of Naturopathy and a
Bachelor of Arts degree from Long Beach State majoring in Sociology and Health
Education. She brings a successful background in Naturopathic healing, teaching,
sales training and marketing to Medizone with 20 years experience working in
corporate environments. Dr. Marshall's previous sales and marketing clients
include: Foundation Health, Plus Financial, Principal Financial Group, Paul
Revere Companies, Discovery Toys, Lotus Development, Pacific Bell, PG&E and Blue
Shield of California. Dr. Marshall is the wife of Ed Marshall, the Company's
CEO.
Kevin R. Andersen, CPA, MS, was appointed Chief Financial Officer in
November 1998. Mr. Andersen is a partner in Andersen, Andersen & Strong L.C.,
Certified Public Accountants, who previously served as the Company's auditors
for the past four years ended December 31, 1997. Mr. Andersen has a Master of
Science in Taxation (graduating Phi Kappa Phi) from UNLV and a Bachelor of
Science in Accountancy from the University of Utah. His professional experience
includes work as a Senior Tax Manager with the national accountancy firm of
Laventhol & Horwath, working in their Las Vegas office and National Tax
Department in Washington, D.C.
Item 10. Executive Compensation
The information for this Item is incorporated by reference to the
Company's definitive proxy statement to be filed pursuant to Regulation 14A
under the Securities Exchange Act of 1934.
Item 11. Security Ownership of Certain Beneficial Owners and Management
The information for this Item is incorporated by reference to the
Company's definitive proxy statement to be filed pursuant to Regulation 14A
under the Securities Exchange Act of 1934, as amended.
15
<PAGE>
Item 12. Certain Relationships and Related Transactions
The information for this Item is incorporated by reference to the
Company's definitive proxy statement to be filed pursuant to Regulation 14A
under the Securities Exchange Act of 1934, as amended.
Item 13. Exhibits and Reports on Form 8-K
(a) Exhibits
Number Description
2 Agreement and Plan of Reorganization dated March 12,
1986 (2)
3.1 Articles of Incorporation of Company (2)
<PAGE>
3.2 Bylaws (2)
3.3 Articles of Amendment to Company's Articles of
Incorporation (3)
10.1 Patent Agreement, dated February 26, 1987.
10.2 Assignment of Distributor Agreement by Terrence O.
McGrath to Medizone Delaware, dated February 4, 1986,
and Distributor Agreement between Terrence O. McGrath
and Dr. J.
Hansler GmbH, dated September 25, 1985 (3)
10.3 Letter confirmation and Protocol, dated June 2, 1986,
with regard to research to be conducted by the State
University of New York at Syracuse (2)
10.4 Consulting Agreement between P.J. Watrous & Co., Inc.
and the Company (2)
10.5 Consulting Agreement between Jeffrey Freed, MD, PC
and the Company (2)
10.6 Consulting Agreement between Joseph Latino and the
Company (2)
10.7 Consulting Agreement between Susan Golden, RN and the
Company (2)
10.8 Stock Option of Joseph Latino (2)
10.9 Stock Option of Jeffrey Freed (2)
10.10 Stock Option of Susan Golden (2)
10.11 Stock Option of Hubert Weinberg (2)
10.12 Agreement dated June 16, 1987, between Company and
Oliver Grace (5)
10.13 Agreement dated June 26, 1987, between Company and
John Grace (5)
10.14 Agreement dated June 26, 1987, between Company and
Oliver Grace (5)
10.15 Agreement dated June 30, 1987, by and among Company
and John C. Black, Dr. Gerard V. Sunnen and Dr.
Priyakant S. Doshi (5)
10.16 License Agreement with MCL Medizone Canada Ltd.
dated November 18, 1987 (5)
16
<PAGE>
10.17 Agreement dated October 1988 by and among
Immunologics, Limited Partnership, John M.
Kells, Y. C. Zee, David C. Bolton and Medizone
International, Inc. (6)
10.18 Form of Stock Purchase Agreement between Company and
individuals who purchased shares from Company (7)
10.19 Letter agreement between Company and Rebus Oil Co.,
Ltd. dated July 28, 1992 (8)
10.20 Letter of understanding between Company and the RMB
Group of Boston dated August 10, 1992 (8)
10.21 Agreement between Company and Rebus Oil Company,
Ltd., dated as of October 20, 1992 (9)
10.22 Letter agreement among Messrs. McGrath, Watrous,
Melera, Chou, Kells, Handel and Pealer, dated as of
November 10, 1992 (9)
10.23 Loan agreement with Messrs. McGrath and Watrous dated
as of November 16, 1992 (9)
10.24 Settlement agreement with former consultant dated
February 12, 1993 (9)
10.25 Consulting Agreement with Joseph S. Latino dated as
of January 1, 1993 (9)
10.26 Consulting Agreement with Arthur P. Bergeron dated as
of January 1, 1993 (9)
10.27 Employment Agreement with Katherine M. Kalinowski
dated as of January 1, 1993 (9)
10.28 Consulting Agreement with Roger Shelley dated as of
January 1, 1993 (9)
10.29 Consulting Agreement with Jeannette Arsenault dated
as of January 1, 1993 (9)
10.30 Loan Agreements between Company and John Kells,
George Handel and John Pealer, executed as of June
11, 1993 (and promissory notes) (9)
10.31 Promissory Note to Joseph S. Latino dated as of
October 26, 1993 and Acceptance Form dated as of
November 26, 1993 (9)
10.32 Letter Agreement dated March 23, 1993 between Company
and the Italian Scientific Society (10)
10.33 Contract between Company and Capmed USA (10)
10.34 Agreement made as of May 18, 1994, among Medizone
International, Inc., Medizone Canada Ltd., John M.
Kells, George Handel, John Pealer, Joseph S. Latino,
Terrence O. McGrath and Philip J. Watrous (11)
10.35 Agreement made as of January 1, 1995, between
Medizone International, Inc. and Joseph S.
Latino (11)
10.36 Agreement made as of January 1, 1995 between Medizone
International, Inc. and Arthur
P. Bergeron (11)
10.37 Agreement made as of January 1, 1995 between Medizone
International, Inc. and Giacomo C. DiGiorgio, MD (11)
17
<PAGE>
10.38 Lease Agreement between Medizone International, Inc.
and Benabi Realty, made on September 27, 1991, as
extended, January 17, 1995 (11)
10.39 Agreement for Sale and Purchase of Shares in Medizone
New Zealand Limited between Richard G. Soloman and
Medizone International, Inc., dated June 22,
1995 (12)
10.40 Shareholders' Agreement relating to Medizone New
Zealand Limited between and among Solwin Investments
Limited, Medizone International, Inc. and Medizone
New Zealand Limited, dated June 22, 1995 (12)
10.41 Licensing Agreement between Medizone International,
Inc. and MNZ, dated June 22, 1995
(12)
10.42 Managing Agent Agreement between Medizone
International, Inc. and Medizone New Zealand
Limited, dated June 22, 1995 (12)
10.43 Lease Agreement between Medizone International, Inc.
and Linmar L.P., dated January 17, 1996 (13)
10.44 Agreement between Medizone International, Inc. and
Multiossigen S.r.l., dated as of September 13,
1996 (14)
10.45 Agreement between Medizone International, Inc. and
JRH Biosciences, Inc., dated April 17, 1997 (15)
10.46 Lease Agreement between Medizone International Inc.
and Eagle Overlook, L.C., made on September 23,
1997 (16)
16 Letter re: change in certifying accountants (17)
(1) Incorporated by reference to the Company's annual report on form 10-K for
the year ended December 31, 1998.
(2) Incorporated by reference to the Company's registration statement on Form
S-18 (Registration No. 2-93277-D), effective May 14, 1985.
(3) Incorporated by reference to the Company's annual report on Form 10-K for
the period ended December 31, 1986.
(4) Incorporated by reference to the Company's current report on Form 8-K, filed
March 13, 1987.
(5) Incorporated by reference to the Company's annual report on Form 10-K for
the period ended December 31, 1987.
(6) Incorporated by reference to the Company's annual report on Form 10-K for
the period ended December 31, 1988.
(7) Incorporated by reference to the Company's annual report on Form 10-K for
the period ended December 31, 1989.
(8) Incorporated by reference to the Company's annual report on Form 10-K for
the period ended December 31, 1990.
(9) Incorporated by reference to the Company's annual report on Form 10-K for
the period ended December 31, 1992.
(10) Incorporated by reference to the Company's current annual report on Form
8-K dated September 8, 1993.
(11) Incorporated by reference to the Company's annual report on Form 10-K for
the period ended December 31, 1994.
(12) Incorporated by reference to the Company's current annual report on Form
8-K, dated June 22, 1995.
(13) Incorporated by reference to the Company's annual report on Form 10-K for
the period ended December 31, 1995.
(14) Incorporated by reference to the Company's current report on Form 8-K,
dated October 17, 1996.
18
<PAGE>
(15) Incorporated by reference to the Company's current report on Form 8-K,
dated May 5, 1997.
(16) Incorporated by reference to the Company's current report on Form 8-K dated
September 24, 1997.
(b) Reports on Form 8-K.
The Company filed a Current Report on Form 8-K on February 8, 2000 to
report the change of auditors.
19
<PAGE>
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the
registrant caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
MEDIZONE INTERNATIONAL, INC.
By: /s/ Edwin G. Marshall
---------------------------------------------
Edwin G. Marshall
President and Chief Executive Officer
Date: March 28, 2000
In accordance with the Exchange Act, this report has been signed below
by the following persons on behalf of the registrant and in the capacities shown
and on the date indicated.
Date: March 28, 2000 /s/ Edwin G. Marshall
-------------------------------------------------------
Edwin G. Marshall, Chief Executive Officer and Director
Date: March 28, 2000 /s/ Gerard V. Sunnen
-------------------------------------------------------
Gerard V. Sunnen, President and Director
Date: March 28, 2000 /s/ William M. Hitt
-------------------------------------------------------
William M. Hitt, Director
Date: March 28, 2000 /s/ Kevin R. Andersen
-------------------------------------------------------
Kevin R. Andersen, Chief Financial Officer
(and Principal Accounting Officer)
20
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED FINANCIAL STATEMENTS
December 31, 1999
<PAGE>
C O N T E N T S
Independent Auditors' Report.................................................F-3
Consolidated Balance Sheet...................................................F-4
Consolidated Statements of Operations........................................F-6
Consolidated Statements of Stockholders' Equity (Deficit) ...................F-7
Consolidated Statements of Cash Flows.......................................F-14
Notes to the Consolidated Financial Statements..............................F-16
F-2
<PAGE>
INDEPENDENT AUDITORS' REPORT
The Board of Directors
Medizone International, Inc. and Subsidiary
(A Development Stage Company)
Stinson Beach, California
We have audited the accompanying consolidated balance sheet of Medizone
International, Inc. and Subsidiary (a development stage company) as of December
31, 1999, and the related consolidated statements of operations, stockholders'
equity (deficit), and cash flows for the years ended December 31, 1999 and 1998
and from inception on January 31, 1986 through December 31, 1999. 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 audits.
We conducted our audits in accordance with generally accepted auditing
standards. 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 consolidated financial position of
Medizone International, Inc. and Subsidiary (a development stage company) as of
December 31, 1999, and the consolidated results of their operations and their
cash flows for the years ended December 31, 1999 and 1998 and from inception on
January 31, 1986 through December 31, 1999, in conformity with generally
accepted accounting principles.
The accompanying consolidated financial statements have been prepared assuming
the Company will continue as a going concern. As discussed in Note 10 to the
consolidated financial statements, the Company has incurred significant losses
which have resulted in an accumulated deficit and a deficit in stockholders'
equity, raising substantial doubt about its ability to continue as a going
concern. Management's plans in regard to these matters are also described in
Note 10. The consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
Jones, Jensen & Company
Salt Lake City, Utah
March 24, 2000
F-3
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Balance Sheet
ASSETS
<TABLE>
<CAPTION>
December 31,
1999
CURRENT ASSETS
<S> <C>
Cash and cash equivalents $ 4,388
-----------------
Total Current Assets 4,388
PROPERTY AND EQUIPMENT (Net) (Notes 1 and 2) 5,667
-----------------
OTHER ASSETS
Receivable from affiliate, net (Note 1) -
-----------------
Total Other Assets -
TOTAL ASSETS $ 10,055
=================
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-4
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Balance Sheet (Continued)
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
<TABLE>
<CAPTION>
December 31,
1999
CURRENT LIABILITIES
<S> <C>
Accounts payable $ 395,370
Accrued expenses (Note 3) 527,045
Notes payable (Note 6) 280,491
-----------------
Total Current Liabilities 1,202,906
-----------------
Total Liabilities 1,202,906
-----------------
COMMITMENTS AND CONTINGENCIES (Note 4)
STOCKHOLDERS' EQUITY (DEFICIT)
Common stock; 250,000,000 shares authorized of $0.001 par value,
149,887,941 shares issued and outstanding 149,888
Additional paid-in capital 12,676,882
Deficit accumulated during the development stage (14,019,621)
-----------------
Total Stockholders' Equity (Deficit) (1,192,851)
-----------------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) $ 10,055
=================
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-5
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Operations
<TABLE>
<CAPTION>
From
Inception on
For the Years Ended January 31,
December 31, 1986 Through
-------------------------------------- December 31,
1999 1998 1999
------------------ ------------------ ------------------
<S> <C> <C> <C>
REVENUE $ - $ - $ 133,349
------------------ ------------------ ------------------
EXPENSES
Cost of sales - - 103,790
Research and development 75,000 13,218 2,407,853
General and administrative 198,308 562,729 11,328,872
Bad debt expense - 48,947 48,947
Depreciation and amortization 1,945 2,673 27,398
------------------ ------------------ ------------------
Total Expenses 275,253 627,567 13,916,860
------------------ ------------------ ------------------
Loss from Operations (275,253) (627,567) (13,783,511)
------------------ ------------------ ------------------
OTHER INCOME (EXPENSE)
Minority interest in loss - - 26,091
Other income - 420 19,780
Gain on sale of subsidiary (Note 1) - 108,417 208,417
Interest expense (22,439) ( 47,031) (843,136)
------------------ ------------------ ------------------
Total Other Income (Expense) (22,439) 61,806 (588,848)
------------------ ------------------ ------------------
LOSS BEFORE EXTRAORDINARY
ITEMS (297,692) (565,761) (14,372,359)
------------------ ------------------ ------------------
EXTRAORDINARY ITEMS
Debt forgiveness (Note 11) 61,510 - 352,738
------------------ ------------------ ------------------
Total Extraordinary Items 61,510 - 352,738
------------------ ------------------ ------------------
NET LOSS $ (236,182) $ ( 565,761) $ (14,019,621)
================== ================== ==================
BASIC LOSS PER SHARE $ (0.00) $ (0.00)
================== ==================
WEIGHTED AVERAGE NUMBER
OF SHARES OUTSTANDING 149,255,666 142,645,000
================== ==================
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-6
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Stockholders' Equity (Deficit)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock Additional During the
----------------------------------------------- Paid-in Development
Shares Amount Subscribed Capital Stage
------------ ---------------- --------------- ---------------- ----------------
<S> <C> <C> <C> <C> <C>
Balance, January 31, 1986 (inception) - $ - $ - $ - $ -
Initial capitalization of Medizone -
Nevada at $0.03 per share 5,500,000 5,500 - 150,128 -
Common shares issued in acquisition
of Medizone - Delaware (Note 1) 37,500,000 37,500 - (37,500) -
Common stock issued for services
rendered in July 1986 at $0.10
per share 50,000 50 - 4,950 -
Common stock issued in conversion
of warrants during 1986 at $0.10
per share 7,814,600 7,815 - 773,645 -
Stock issuance costs - - - (105,312) -
Net loss for the year ended
December 31, 1986 - - - - (796,068)
------------ ---------------- --------------- ---------------- ----------------
Balance, December 31, 1986 50,864,600 50,865 - 785,911 (796,068)
Common stock issued upon exercise
of warrants in January 1987 at $0.10
per share 2,600 2 - 257 -
Common stock issued for patent in
March 1987 at $0.69 per share 1,000,000 1,000 - 692,750 -
Common stock issued for cash in
June 1987 at an average price of
$0.16 per share 950,000 950 - 149,050 -
Common stock issued for services
in June and July 1987 at an
average price of $0.12 per share 203,167 203 - 24,314 -
Common stock issued through
exercise of options in August 1987
at $1.75 per share 250,000 250 - 437,250 -
Net loss for the year ended
December 31, 1987 - - - - (2,749,400)
------------ ---------------- --------------- ---------------- ----------------
Balance, December 31, 1987 53,270,367 $ 53,270 $ - $ 2,089,532 $ (3,545,468)
------------ ---------------- --------------- ---------------- ----------------
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-7
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Stockholders' Equity (Deficit) (Continued)
<TABLE>
<CAPTION>
Deficit
Additional Accumulated
Common Stock Additional During the
-------------------------------------------------- Paid-in Development
Shares Amount Subscribed Capital Stage
--------------- --------------- --------------- --------------- --------------------
<S> <C> <C> <C> <C> <C>
Balance, December 31, 1987 53,270,367 $ 53,270 $ - $ 2,089,532 $ (3,545,468)
Common stock issued through exercise
of options in January 1988 at $0.50
per share 200,000 200 - 99,800 -
Common stock issued for cash in
September 1988 at $0.08 per share 1,000,000 1,000 - 79,000 -
Common stock issued for services
at an average price of $0.23
per share 35,000 35 - 7,965 -
Additional capital contributed - - - 174,126 -
Net loss for the year ended
December 31, 1988 - - - - (714,347)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1988 54,505,367 54,505 - 2,450,423 (4,259,815)
Common stock issued for services
at an average price of $0.18 per
share 261,889 262 - 46,363 -
Common stock issued for cash at
an average price of $0.05 per share 5,790,000 5,790 - 285,710 -
Common stock issued for services
and in lieu of outstanding debt at
an average price of $0.12 per share 4,749,532 4,750 - 578,978 -
Common stock issued upon exercise
of options at $0.16 per share 375,000 375 - 59,125 -
Net loss for the year ended
December 31, 1989 - - - - (862,051)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1989 65,681,788 $ 65,682 $ - $ 3,420,599 $ (5,121,866)
--------------- --------------- --------------- --------------- ---------------
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-8
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Stockholders' Equity (Deficit) (Continued)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock Additional During the
------------------------------------------------- Paid-in Development
Shares Amount Subscribed Capital Stage
-------------- ---------------- --------------- ---------------- -----------------
<S> <C> <C> <C> <C> <C>
Balance, December 31, 1989 65,681,788 $ 65,682 $ - $ 3,420,599 $ (5,121,866)
Common stock issued for services
at $0.10 per share 880,000 880 - 87,120 -
Common stock issued for cash at an
average price of $0.04 per share 4,250,000 4,250 - 175,250 -
Common stock issued for services
and in lieu of outstanding debt at
an average price of $0.06 per share 2,422,727 2,423 - 137,577 -
Additional capital contributed - - - 100,000 -
Net loss for the year ended
December 31, 1990 - - - - (606,309)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1990 73,234,515 73,235 - 3,920,546 (5,728,175)
Common stock issued for cash at an
average price of $0.07 per share 4,366,667 4,366 - 305,634 -
Common stock issued for services
at an average price of $0.17 per
share 425,000 425 - 72,075 -
Common stock issued through
exercise of options at an average
price of $0.45 per share 450,000 450 - 204,050 -
Additional capital contributed - - - 5,000 -
Net loss for the year ended
December 31, 1991 - - - - (1,220,152)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1991 78,476,182 $ 78,476 $ - $ 4,507,305 $ (6,948,327)
--------------- --------------- --------------- --------------- ----------------
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-9
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Stockholders' Equity (Deficit) (Continued)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock Additional During the
------------------------------------------------- Paid-in Development
Shares Amount Subscribed Capital Stage
-------------- ---------------- --------------- ---------------- -----------------
<S> <C> <C> <C> <C> <C>
Balance, December 31, 1991 78,476,182 $ 78,476 $ - $ 4,507,305 $ (6,948,327)
Common stock issued for services
at $0.20 per share 151,500 152 - 30,148 -
Common stock issued in lieu of
debt at $0.15 per share 250,000 250 - 37,250 -
Common stock issued for cash at
an average price of $0.16 per share 2,702,335 2,702 - 427,648 -
Common stock issued through
exercise of options at $0.50
per share 250,000 250 - 124,750 -
Additional capital contributed - - - 81,100 -
Net loss for the year ended
December 31, 1992 - - - - (649,941)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1992 81,830,017 81,830 - 5,208,201 (7,598,268)
Common stock issued for services
at an average price of $0.10
per share 5,347,219 5,347 - 542,859 -
Common stock issued for cash at
an average price of $0.18 per share 1,471,666 1,472 - 269,528 -
Common shares subscribed for
at $0.10 per share - - 2,619 259,296 -
Net loss for the year ended
December 31, 1993 - - - - (1,598,342)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1993 88,648,902 $ 88,649 $ 2,619 $ 6,279,884 $ (9,196,610)
--------------- --------------- --------------- --------------- ---------------
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-10
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Stockholders' Equity (Deficit) (Continued)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock Additional During the
------------------------------------------------- Paid-in Development
Shares Amount Subscribed Capital Stage
-------------- ---------------- --------------- ---------------- -----------------
<S> <C> <C> <C> <C> <C>
Balance, December 31, 1993 88,648,902 $ 88,649 $ 2,619 $ 6,279,884 $ (9,196,610)
Common stock issued for services
at $0.10 per share 1,431,590 1,431 - 141,727 -
Common shares subscribed for at
$0.10 per share - - 9,552 945,682 -
Common shares subscribed for as
cancellations of indebtedness at
$0.10 per share - - 417 41,234 -
Common shares subscribed for as
cancellation of indebtedness at
$0.18 per share - - 11,250 2,022,379 -
Issuance of subscribed stock 10,384,900 10,385 (10,385) - -
Issuance of shares in recognition
of disparity in purchase price in
offering 1,125,834 1,126 - (1,126) -
Prior period adjustment (Note 8) - - - - 219,422
Net loss for the year ended
December 31, 1994 - - - - (1,126,315)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1994 101,591,226 $ 101,591 $ 13,453 $ 9,429,780 $ (10,103,503)
--------------- --------------- --------------- --------------- ---------------
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-11
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Stockholders' Equity (Deficit) (Continued)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock Additional During the
------------------------------------------------- Paid-in Development
Shares Amount Subscribed Capital Stage
-------------- ---------------- --------------- ---------------- -----------------
<S> <C> <C> <C> <C> <C>
Balance, December 31, 1994 101,591,226 $ 101,591 $ 13,453 $ 9,429,780 $ (10,103,503)
Redeemable common shares
converted to common stock (Note 9) 200,000 200 - 39,800 -
Common stock issued for services
at $0.10 per share 2,050,000 2,050 - 202,950 -
Issuance of subscribed stock 17,524,860 17,524 (17,524) - -
Cancellation of common shares (1,242,727) (1,242) - (70,563) -
Common shares subscribed for at
$0.10 per share - - 9,118 902,707 -
Prior period adjustment (Note 8) - - - - 71,806
Additional capital contributed - - - 50,000 -
Net loss for the year ended
December 31, 1995 - - - - (1,081,027)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1995 120,123,359 120,123 5,047 10,554,674 (11,112,724)
Common stock issued for cash
at $0.10 per share 100,000 100 - 9,900 -
Common stock issued for services
at $0.10 per share 1,415,875 1,416 - 140,171 -
Issuance of subscribed stock 8,412,379 8,413 (8,413) - -
Common shares subscribed for
at $0.11 per share - - 6,456 718,991 -
Net loss for the year ended
December 31, 1996 - - - - (1,329,395)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1996 130,051,613 $ 130,052 $ 3,090 $ 11,423,736 $ (12,442,119)
--------------- --------------- --------------- --------------- ---------------
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-12
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Stockholders' Equity (Deficit) (Continued)
<TABLE>
<CAPTION>
Deficit
Accumulated
Common Stock Additional During the
------------------------------------------------- Paid-in Development
Shares Amount Subscribed Capital Stage
-------------- ---------------- --------------- ---------------- -----------------
<S> <C> <C> <C> <C> <C>
Balance, December 31, 1996 130,051,613 $ 130,052 $ 3,090 $ 11,423,736 $ (12,442,119)
Issuance of subscribed stock 3,089,680 3,090 (3,090) - -
Common shares subscribed for
at $0.07 per share - - 5,714 394,287 -
Common stock issued for services
at $0.10 per share 3,746,336 3,746 - 370,886 -
Net loss for the year ended
December 31, 1997 - - - - (775,559)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1997 136,887,629 136,888 5,714 12,188,909 (13,217,678)
Common stock issued through
exercise of warrants at $0.07
per share 857,142 857 - 59,143 -
Common stock issued in lieu of
debt at $0.05 per share 864,747 865 - 42,372 -
Issuance of subscribed stock 5,714,286 5,714 (5,714) - -
Cancellation of common shares (630,000) (630) - 630 -
Common stock issued for services
at $0.05 per share 3,465,000 3,465 - 169,786 -
Common stock issued for services
at $0.09 per share 750,000 750 - 63,785 -
Common stock issued in lieu of
debt at $0.09 per share 967,630 967 - 82,214 -
Common stock issued for services
at $0.08 per share 50,000 50 - 3,700 -
Net loss for the year ended
December 31, 1998 - - - - (565,761)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1998 148,926,434 148,926 - 12,610,539 (13,783,439)
Common stock issued for services
at $0.07 per share 25,000 25 - 1,725 -
Common stock issued through
exercise of warrants at $0.07
per share 936,507 937 - 64,618 -
Net loss for the year ended
December 31, 1999 - - - - (236,182)
--------------- --------------- --------------- --------------- ---------------
Balance, December 31, 1999 149,887,941 $ 149,888 $ - $ 12,676,882 $ (14,019,621)
=============== ============== =============== =============== ===============
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-13
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Cash Flows
<TABLE>
<CAPTION>
From
Inception on
For the Years Ended January 31,
December 31, 1986 Through
---------------------------------- December 31,
1999 1998 1999
---------------- ----------------- -----------------
CASH FLOWS FROM OPERATING ACTIVITIES
<S> <C> <C> <C>
Net loss $ (236,182) $ (565,761) $ (14,019,621)
Adjustments to reconcile net loss to net cash
used by operating activities:
Depreciation and amortization 1,945 2,673 27,398
Stock issued for services 1,750 241,536 2,869,166
Bad debt expense - 48,947 48,947
Minority interest in loss - - (26,091)
Loss on disposal of assets - - 693,752
Gain on settlement of debt (61,510) - (61,510)
Changes in assets and liabilities:
(Increase) decrease in prepaid expenses
and deposits - 11,631 (48,947)
Increase (decrease) in accounts payable (13,252) (18,698) 691,250
Increase (decrease) in accrued expenses 238,439 69,783 587,067
---------------- ----------------- -----------------
Net Cash Used by Operating Activities (68,810) ( 209,889) (9,238,589)
---------------- ----------------- -----------------
CASH FLOWS FROM INVESTING ACTIVITIES
Organization costs - - (8,904)
Purchase of fixed assets - (2,017) (24,159)
---------------- ----------------- -----------------
Net Cash Used by Investing Activities - (2,017) (33,063)
---------------- ----------------- -----------------
CASH FLOWS FROM FINANCING ACTIVITIES
Principle payments on notes payable - (3,624) (192,774)
Cash received from notes payable - 25,000 1,106,518
Capital contributions - - 421,847
Stock issuance costs - - (105,312)
Increase in minority interest - - 14,470
Issuance of common stock for cash 65,555 60,000 8,031,291
---------------- ----------------- -----------------
Net Cash Provided by Financing Activities 65,555 81,376 9,276,040
---------------- ----------------- -----------------
NET INCREASE (DECREASE) IN CASH (3,255) (130,530) 4,388
CASH AT BEGINNING OF PERIOD 7,643 138,173 -
---------------- ----------------- -----------------
CASH AT END OF PERIOD $ 4,388 $ 7,643 $ 4,388
================ ================= =================
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
F-14
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Consolidated Statements of Cash Flows (Continued)
<TABLE>
<CAPTION>
From
Inception on
For the Years Ended January 31,
December 31, 1986 Through
---------------------------------- December 31,
1999 1998 1999
---------------- ---------------- -----------------
SUPPLEMENTAL CASH FLOW INFORMATION
CASH PAID FOR:
<S> <C> <C> <C>
Interest $ - $ - $ 26,483
Income taxes $ - $ - $ -
NON-CASH FINANCING ACTIVITIES:
Stock issued for services $ 1,750 $ 241,536 $ 2,869,166
Stock issued in conversion of debt to common stock $ - $ 126,418 $ 3,776,293
Stock issued for license agreement and patent $ - $ - $ 693,752
</TABLE>
F-15
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
a. Organization
The consolidated financial statements presented are those of
Medizone International, Inc. (Medizone-Nevada) and its
wholly-owned subsidiaries, Medizone International, Inc.
(Medizone-Delaware) and Medizone Canada, Ltd. (MedCan).
Collectively, they are referred to herein as the "Company."
Medizone-Nevada was incorporated under the name of Madison
Funding, Inc. on August 27, 1984 under the laws of the State of
Nevada for the purpose of investing in, acquiring, operating and
disposing of businesses or assets of any nature. Effective March
26, 1986, Medizone-Nevada issued 37,500,000 shares of its common
stock in exchange for the issued and outstanding common stock of
Medizone-Delaware.
Medizone-Delaware was incorporated on January 31, 1986 under the
state laws of Delaware. Medizone-Delaware was organized to seek
regulatory approval for a MEDIZONE (R) drug, a precise mixture of
ozone and oxygen for the purpose of inactivating lipid enveloped
viruses for the intended purpose of decontaminating blood and
blood products and assisting in the treatment of certain diseases.
It is also trying to develop or acquire the related technology and
equipment for the medical application of the products, including
the drug production and delivery system.
At the time of the acquisition of Medizone-Delaware,
Medizone-Nevada was essentially inactive, with no operations and
minimal assets. Additionally, the exchange of Medizone-Nevada=s
common stock for the common stock of Medizone-Delaware resulted in
the former stockholders of Medizone-Delaware obtaining control of
Medizone-Nevada. Accordingly, Medizone-Delaware became the
continuing entity for accounting purposes, and the transaction was
accounted for as a recapitalization of Medizone-Delaware with no
adjustment to the basis of Medizone-Delaware=s assets acquired or
liabilities assumed. For legal purposes, Medizone-Nevada was the
surviving entity.
On November 18, 1987, Medizone Canada Ltd. (MedCan) was
incorporated under the laws of the Province of British Columbia.
Shortly thereafter, MedCan entered into a license agreement with
the Company wherein the Company transferred to MedCan the licenses
and rights necessary to permit MedCan to hold substantially the
same rights with respect to the medical applications of ozone in
Canada as the Company does in the United States. As consideration
for the transfer, the Company received 3,000,000 shares of MedCan
and, in addition, purchased 1 share for the sum of $1.00. Under a
separate agreement among the Company, MedCan and Australian Gold
Mines Corporation (AGMC), (which later changed its name to
International Blue Sun Resource Corporation), AGMC purchased
130,000 shares of MedCan for $100,000. On December 23, 1988,
MedCan was recapitalized in a transaction in which the majority of
its shares were exchanged for shares of KPC Investments, (a Utah
corporation) (KPC). Following this transaction, the Company owned
25,029,921 shares of KPC, representing 72% of the outstanding
shares. KPC then changed its name to Medizone Canada, Ltd. (MCL).
MedCan acquired all of the assets of MCL, consisting solely of
cash in the amount of approximately $89,000.
F-16
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(Continued)
a. Organization (Continued)
In June 1998, the Company sold its interest in MCL for $125,000
cash debt assumed of $8,417 less fees of $25,000 in a private
transaction which resulted in a gain of $108,417 for the year
ended December 31, 1998. The Company retained ownership, however,
of all of the issued and outstanding stock of MedCan, the Canadian
subsidiary.
b. Formation of Joint Venture
On June 22, 1995, the Company entered into a series of contracts
which resulted in the formation of a joint venture subsidiary
incorporated in New Zealand, Medizone New Zealand Limited (MNZ).
MNZ, a privately held corporation equally owned by the Company and
Solwin Investments Limited (Solwin), a New Zealand corporation, is
a research and development stage company whose objective is to
obtain regulatory approval for the distribution of the Company's
patented technology in New Zealand, Australia, South East Asia and
the South Pacific Islands.
Pursuant to the contracts, the Company purchased 100% of MNZ from
Richard G. Soloman, a New Zealand citizen, who became a director
of the Company in January 1996 and who caused the formation of MNZ
on June 22, 1995. Contemporaneously with this transaction, the
Company sold 50% of MNZ to Solwin, a corporation owned by Soloman,
for $150,000, of which $50,000 was thereupon loaned by the Company
to MNZ on a demand basis (see Note 1(i)).
Contemporaneous with the creation of the above share structure,
the Company and MNZ entered into a Licensing Agreement (the
Licensing Agreement) and a Managing Agent Agreement (the Managing
Agent Agreement).
Pursuant to the Licensing Agreement, the Company granted an
exclusive license to MNZ for its process and equipment patents and
trademark in New Zealand. MNZ has agreed to apply for
corresponding patent protection for the patents in New Zealand and
to use its best effort to exploit the rights granted in the
agreement. The License Agreement shall terminate on the date of
the expiration of the last to expire of any patent obtained in New
Zealand, or, if no such patents are obtained, on June 22, 2010.
The Company is to receive a guaranteed minimum royalty (the
Guaranteed Minimum Royalty) in an amount to be agreed to by the
Company and MNZ, commencing in the third year after all necessary
regulatory approvals requisite to the license, use or distribution
of the Company's proprietary technology have been obtained in New
Zealand. If the Company and MNZ are unable to agree upon the
amount of the Guaranteed Minimum Royalty, the Company may
terminate the license on thirty days notice. Commencing on the
first sale to a user by MNZ, the Company shall receive a sales
royalty in an amount equal to 10% of MNZ's gross annual sales
under the License Agreement.
F-17
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(Continued)
b. Formation of Joint Venture (Continued)
Pursuant to the Managing Agent Agreement, MNZ will act as the
Company's agent in the finding of other licensees of the Company's
patents and trademark in the following countries: Autralasia
(including Australia and New Zealand), the South Pacific Islands
and South East Asia (including the Philippines, Indonesia and
Vietnam). Licensing fees obtained as a result of the Managing
Agent Agreement shall be divided between the Company and MNZ on a
sliding scale as set forth below:
<TABLE>
<CAPTION>
Medizone Medizone
International, New Zealand
Inc. Limited
<S> <C> <C>
Initial license 50% 50%
Subsequent license fees up to $500,000 50% 50%
Subsequent license fees between $500,000
and $750,000 75% 25%
Subsequent license fees in excess of $750,000 85% 15%
</TABLE>
MNZ and the Company will also divide any net royalties paid to the
Company pursuant to any license obtained pursuant to the Managing
Agent Agreement, with MNZ being paid 10% of the net royalties and
the Company receiving 90% of the net royalties.
The Managing Agent Agreement shall expire on the termination or
expiration of the last of the licenses obtained pursuant thereto,
subject to earlier termination by the Company upon an occurrence
of certain events.
Pursuant to Emerging Issued Task Force Statement No. 89-7, the
Company recognized a $100,000 gain on the sale of MNZ to Solwin.
The investment in the joint venture has been recorded under the
equity method of accounting as the Company does not have ultimate
control of the joint venture. The investment is recorded at $-0-
as of December 31, 1999.
c. Business Activities
The Company's objective is to gain regulatory approval for the
medical uses of ozone to inactivate certain viruses and to assist
in the treatment of certain diseases and to develop, promote and
distribute ozone-generating equipment and related products for
medical applications.
F-18
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(Continued)
c. Business Activities (Continued)
By letter agreement with the Italian Scientific Society for
Oxygen-Ozone Therapy (ISSOT) in Bergamo, Italy, dated March 23,
1993, the Company entered into a collaborative arrangement to
research and examine the efficacy of ozone therapy and the
Company's technology in the treatment of various blood-related
human diseases. The research is to be conducted by ISSOT in Italy,
under the direction of a research group assembled by the Italian
Ministry of Health.
On May 16, 1994, the Company announced that human trials were to
commence at the University of Naples ("Naples"). However, after
the termination of the Company's former President, the Company=s
inquiry into the conduct of its operations during the former
President's tenure, that disclosed that human clinical trials of
the Company's ozone therapy on patients infected with either
Acquired Immunodeficiency Syndrome (AIDS) or Hepatitis B (chronic
active) has not been authorized by Naples or commenced at that
institution. The Company also learned that the Italian Ministry of
Health had not issued approvals for human clinical trials to
commence at certain sites as previously disclosed. While the
ethics committees at certain university hospitals have stated
their approval for the Company to conduct Phase II trials, they
would require the Company to have either completed a large animal
study and Phase I human clinical trials or to have these
requirements waived. The Company has never performed a large
animal study or Phase I human clinical trials and does not possess
the necessary data with respect to its ozone therapy to commence
Phase II study. However, there does exist a broad use and
understanding of ozone therapy throughout Europe and there have
been numerous scientific articles published in European medical
journals describing the use of ozone on humans.
F-19
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(Continued)
c. Business Activities (Continued)
The Company has held discussions with an Italian Contract Research
Organization (the ICRO) with a view to having the ICRO act as an
intermediary on behalf of the Company with the Italian Ministry of
Health and prepare a written submission to the Italian Ministry of
Health regarding the data in the public domain on ozone therapy
with a view to having the Italian Ministry of Health accept this
material as proof of safety, toxicity and tolerance of the use of
the Company's ozone technology on humans in lieu of having the
Company perform a large animal study and possibly even Phase I
human clinical trials. The ICRO would also design a research
program and protocols for human clinical trials which would meet
the standards of the European Union (EU) and Food and Drug
Administration (FDA), monitor the clinical terms and collect and
prepare analyses of the data produced by the trials. The Company
will not be able to enter into a formal contract with the ICRO
unless it obtains additional funding. If the Italian Ministry of
Health does not accept the published evidence on the use of ozone
therapy on humans, the Company will be required to perform its own
Phase I human clinical trials and possibly a large animal study.
In late 1997, the Company entered into discussions with Italian
and Belgium clinicians with regard to them performing Phase I
human clinical trials. However, assuming the Italian Ministry of
Health did not grant the Company's request for waiver, no formal
agreements with these clinicians would be signed and the studies
would not begin until the company obtains additional funding. The
Company estimates that it would require an infusion of
approximately $1.5 million to advance the above-described research
initiatives through the completion of a Phase III human clinical
trials and submission of the data for approval to the Italian
Ministry of Health.
d. Accounting Methods
The Company's consolidated financial statements are prepared using
the accrual method of accounting. The Company has elected a
December 31 year end.
e. Cash and Cash Equivalents
Cash equivalents include short-term, highly liquid investments
with maturities of three months or less at the time of
acquisition.
f. Basic Loss Per Share
The computations of basic loss per share of common stock are based
on the weighted average number of common shares outstanding during
the period of the consolidated financial statements as follows:
F-20
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(Continued)
f. Basic Loss Per Share (Continued)
<TABLE>
<CAPTION>
For the Years Ended
December 31,
1999 1998
------------------ ------------------
<S> <C> <C>
Numerator (net loss) $ (236,182) $ (565,761)
Denominator (weighted
average number of
shares outstanding) 149,255,666 142,645,000
Loss per share $ (0.00) $ (0.00)
</TABLE>
Common stock equivalents, consisting of warrants and options, have
not been included in the calculation as their effect is
antidilutive for the periods presented.
g. Change in Accounting Principle
The Financial Accounting Standards Board has issued Statement of
Financial Accounting Standards ("SFAS") No. 128, "Earnings Per
Share" and Statement of Financial Accounting Standards No. 129
"Disclosures of Information About an Entity's Capital Structure."
SFAS No. 128 provides a different method of calculating earnings
per share than was previously used in accordance with APB Opinion
No. 15 "Earnings Per Share." SFAS No. 128 provides for the
calculation of "Basic" and "Dilutive" earnings per share. Basic
earnings per share includes no dilution and is computed by
dividing income (loss) available to common shareholders by the
weighted average number of common shares outstanding for the
period. Diluted earnings per share reflects the potential dilution
of securities that could share in the earnings of an entity,
similar to fully diluted earnings per share. SFAS No. 129
establishes standards for disclosing information about an entity's
capital structure. SFAS No. 128 and SFAS No. 129 are effective for
financial statements issued for periods ending after December 15,
1997. The Company has adopted these two standards although they
did not have a material impact on the Company's consolidated
financial statements.
F-21
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(Continued)
g. Change in Accounting Principle (Continued)
The Financial Accounting Standards Board has also issued SFAS No.
130, "Reporting Comprehensive Income" and SFAS No. 131,
"Disclosures about Segments of an Enterprise and Related
Information." SFAS No. 130 establishes standards for reporting and
display of comprehensive income, its components and accumulated
balances. Comprehensive income is defined to include all changes
in equity except those resulting from investments by owners and
distributions to owners. Among other disclosures, SFAS No. 130
requires that all items that are required to be recognized under
current accounting standards as components of comprehensive income
be reported in a financial statement that displays with the same
prominence as other financial statements. SFAS No. 131 supersedes
SFAS No. 14 "Financial Reporting for Segments of a Business
Enterprise." SFAS No. 131 establishes standards on the way that
public companies report financial information about operating
segments in annual financial statements and requires reporting of
selected information about operating segments in interim financial
statements issued to the public. It also establishes standards for
disclosure regarding products and services, geographic areas and
major customers. SFAS No. 131 defines operating segments as
components of a company about which separate financial information
is available that is evaluated regularly by the chief operating
decision maker in deciding how to allocate resources and in
assessing performance. The adoption of these statements did not
have a material impact on the Company's financial statements.
In February 1998, the Financial Accounting Standards Board
("FASB") has issued Statement of Financial Accounting Standard
("SFAS") No 132. "Employers' Disclosures about Pensions and other
Postretirement Benefits" which standardizes the disclosure
requirements for pensions and other Postretirement benefits and
requires additional information on changes in the benefit
obligations and fair values of plan assets that will facilitate
financial analysis. SFAS No. 132 is effective for years beginning
after December 15, 1997 and requires comparative information for
earlier years to be restated, unless such information is not
readily available. The adoption of this statement had no material
impact on the Company=s financial statements.
F-22
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(Continued)
g. Change in Accounting Principle (Continued)
In June 1998, the FASB issued SFAS No. 133, "Accounting for
Derivative Instruments and Hedging Activities" which requires
companies to record derivatives as assets or liabilities, measured
at fair market value. Gains or losses resulting from changes in
the values of those derivatives would be accounted for depending
on the use of the derivative and whether it qualifies for hedge
accounting. The key criterion for hedge accounting is that the
hedging relationship must be highly effective in achieving
offsetting changes in fair value or cash flows. SFAS No. 133 is
effective for all fiscal quarters of fiscal years beginning after
June 15, 1999. Management believes the adoption of this statement
will have no material impact on the Company=s financial
statements.
h. Property and Equipment
Property and equipment is recorded at cost. Major additions and
improvement are capitalized. The cost and related accumulated
depreciation of equipment retired or sold are removed from the
accounts and any differences between the undepreciated amount and
the proceeds from the sale are recorded as gain or loss on sale of
equipment. Depreciation is computed using the straight-line method
over a period of five years.
i. Receivable from Affiliate
The Company loaned $50,000 in 1996 to MNZ, the joint venture
company, on a demand basis. MNZ currently has minimal assets and
operations. Management has recorded an allowance for the full
amount of the loan as of December 31, 1999.
j. Provision for Taxes
At December 31, 1999, the Company has net operating loss
carryforwards of approximately $12,000,000 that may be offset
against future taxable income through 2019. No tax benefit has
been reported in the consolidated financial statements because the
Company believes there is a 50% or greater chance the net
operating loss carryforwards will not be used. Accordingly, the
potential tax benefits of the net operating loss carryforwards are
offset by a valuation allowance of the same amount.
k. Principles of Consolidation
The consolidated financial statements include those of Medizone
International, Inc. (Medizone-Nevada) and its wholly-owned
subsidiaries, Medizone International, Inc.
(Medizone-Delaware) and Medizone Canada, Ltd (MedCan).
All material intercompany accounts and transactions have been
eliminated.
F-23
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(Continued)
l. Estimates
The preparation of financial statements in conformity with
generally accepted accounting principles 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 reporting
period. Actual results could differ from those estimates.
m. Advertising
The Company follows the policy of charging the costs of
advertising to expense as incurred.
n. Stock Based Compensation
In October 1995, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standard No. 123, Accounting for
Stock-Based Compensation. The Company currently accounts for its
stock-based compensation plans using the accounting prescribed by
Accounting Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees. Since the Company is not required to adopt
the fair value based recognition provisions prescribed under SFAS
No. 123, it has elected to comply with the disclosure requirements
set forth in the Statement, which includes disclosing proforma net
income (loss) as if the fair value based method of accounting had
been applied. (See Note 7.)
o. Patents
In March 1987, the Company acquired a patent from Immunologics
Limited Partnership (Immunologics) in exchange for 1,000,000
shares of the Company's common stock. In 1988, Immunologics
purchased for $25,000, 5,000,000 shares of the Company=s common
stock from the former Chairman and Chief Executive Officer of the
Company.
The patent covers a procedure for "ozone decontamination of blood
and blood products" through the treatment of stored blood and
blood components. The Board of Directors assigned a value of
approximately $700,000 to the patent based upon the fair market
value of the stock on the date of acquisition together with
related legal costs. The Company charged the cost of the patent to
research and development expense at acquisition because the
technologies covered by the patent have not been approved by the
FDA. Additionally, the Company agreed to pay the seller a royalty
fee equal to 3% of the net receipts received by the Company in
connection with the sale of any product, device or apparatus which
embodies the patent. The Company's management considers the
acquisition and retention of the patent to be material in its
development and prospects. In 1992, the General Partner of
Immunologics became chairman of the Company's Board of Directors
and subsequently resigned from the Company=s Board of Directors in
September 1993.
F-24
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(Continued)
p. Revenue Recognition Policy
The Company currently ha no source of revenues. Revenue
recognition policies will be determined when principal operations
begin.
NOTE 2 - PROPERTY AND EQUIPMENT
Property and equipment consists of the following at December 31,
1999:
Office equipment $ 4,318
Furniture and fixtures 6,307
------------------
10,625
Accumulated depreciation (4,958)
------------------
Net property and equipment $ 5,667
==================
Depreciation expense for the years ended December 31, 1999
and 1998 was $1,945 and $2,673, respectively.
NOTE 3 - ACCRUED EXPENSES
Accrued expenses consist of the following at December 31, 1999:
Accrued payroll $ 378,000
Accrued interest 149,045
------------------
Total $ 527,045
==================
NOTE 4 - COMMITMENTS AND CONTINGENCIES
The Company retains an investor relations firm to act as the
Company's liaison with the brokerage community. The agreement was
originally for a period of one year, but has been extended by the
parties for additional one year periods. It receives a monthly
payment of $2,000, plus expenses. As additional compensation in
1996, it received 250,000 shares of the Company's common stock,
restricted under the federal securities laws.
On December 3, 1999, the Company filed a complaint in the Third
District Court of Salt Lake County, Utah against its former Chief
Financial Officer. Among other things, the compliant filed by the
Company sought a declaration from the Court regarding the
enforceability of the former officer's employment contract, the
right of the Company to terminate his employment and other relief.
A verbal settlement has been agreed upon, under the terms of which
the Company agreed to withdraw its compliant with prejudice and
the former officer waived any further claim for wages or other
compensation under his employment agreement. In addition, the
former officer consented to the cancellation of 2,000,000 shares
of common stock issued to him in prior years. The settlement
agreement has not yet been finalized.
F-25
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 4 - COMMITMENTS AND CONTINGENCIES (Continued)
Therefore, the debt accrued as compensation to the former officer
has been recorded at December 31, 1999, until a final written
agreement has been reached. Furthermore, the 2,000,000 shares
remain outstanding at December 31, 1999 until the shares are
received and canceled.
In addition, the Board of Directors approved the following
salaries for its key officers during 1999 to commence January 1,
2000: 1) $170,000 a year for the Company's C.E.O., 2) $170,000 a
year for the Company's President and Director of Research, 3)
$36,000 a year for the Company's C.F.O. and 4) $95,000 a year for
the Company's C.O.O. and Corporate Secretary.
NOTE 5 - ISSUANCE OF COMMON STOCK AND WARRANTS
Unless otherwise stated, all transactions shown below were with
unrelated parties and the securities issued were restricted.
Medizone-Nevada initially issued 5,500,000 shares in a private
transaction.
On March 26, 1986, Medizone-Nevada issued 37,500,000 shares of
common stock, representing 87.2% of the then outstanding shares,
to the stockholders of Medizone-Delaware, including two officers
and directors, in exchange for all of the shares of
Medizone-Delaware. The costs of the transactions were offset
against paid-in capital.
In July 1986, the Company issued 50,000 shares of common stock to
individuals for services rendered.
During the period from August 1986 through October 31, 1986, the
final expiration date for exercise, warrants to purchase 7,814,600
shares together with cash totaling $781,460 were received by the
Company which then issued 7,814,600 shares of new common stock. In
January 1987, an additional 2,600 shares were issued in exchange
for warrants and cash of $259.
In March 1987, the Company issued 1,000,000 shares of common stock
in exchange for a patent (see Note 1).
In June 1987, the Company issued 950,000 shares to individuals in
private transactions for aggregate proceeds of $150,000.
During the period from June 1987 through July 1987, the Company
issued 203,167 shares of common stock to various vendors and
individuals for services rendered in 1986 and 1987.
On August 26, 1987, an officer of the Company exercised options to
purchase 250,000 shares of common stock. In January 1988, two
holders exercised their options and acquired an aggregate of
200,000 shares of common stock.
F-26
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 5 - ISSUANCE OF COMMON STOCK AND WARRANTS (Continued)
On September 26, 1988, the Company sold, in a private placement,
1,000,000 shares of common stock at $0.08 per share to an
individual.
During 1988, the Company issued a total of 35,000 shares of
common stock for services.
During 1989, the Company issued 261,889 shares of common stock to
various vendors and individuals for services rendered in 1988 and
1989.
During 1989, the Company issued 5,790,000 shares to individuals in
private transactions for aggregate proceeds of $291,500.
Also during 1989, the Company satisfied obligations for notes
payable to and accrued interest due to unrelated individuals
totaling $377,539 by the issuance of 3,899,532 shares of common
stock. The Company issued 250,000 shares of common stock to an
officer and 600,000 shares of common stock to three advisors to
the Company as additional compensation for work done for the
Company. These issuances were ascribed values of $60,650 and
$145,539, respectively, by the Company. Also during 1989, two
holders exercised their options and acquired an aggregate of
375,000 shares of common stock.
During 1990, the following equity transactions occurred: The
Company issued 4,250,000 shares to individuals in private
transactions for aggregate proceeds of $179,500; the Company
satisfied obligations totaling $125,000 to the former vice
president, secretary and treasurer as well as director by issuing
2,272,727 shares of common stock at $0.55 per share; the Company
satisfied an outstanding account payable to an unrelated
individual totaling $15,000 by the issuance of 150,000 shares of
common stock at $0.10 per share; and the Company issued to an
employee and four other unrelated persons as compensation or
payment a total of 880,000 shares of common stock to which it
ascribed a value of $88,000.
During 1991, the following equity transactions occurred: The
Company issued 4,366,667 shares to individuals in private
transactions for aggregate proceeds of $310,000; the Company
issued a total of 425,000 shares of common stock for services and
accrued liabilities of which an aggregate of 100,000 shares were
issued to two directors; and three holders exercised their options
and acquired an aggregate of 450,000 shares of common stock.
During 1992, the following equity transactions occurred: The
Company issued 2,702,335 shares to individuals in private
transactions for aggregate proceeds of $430,350; the Company
issued a total of 401,500 shares of common stock for services and
accrued liabilities; holders exercised options and acquired an
aggregate of 250,000 shares of common stock.
F-27
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 5 - ISSUANCE OF COMMON STOCK AND WARRANTS (Continued)
During 1993, the following equity transactions occurred: The
Company issued 1,471,666 shares to individuals in private
transactions for aggregate proceeds of $271,000; the Company
issued a total of 5,347,219 shares of common stock for services.
Also, during 1993, a total of $261,915 was received in cash for
2,619,150 shares subscribed as a result of a private placement
offering. The offering commenced as of November 26, 1993, with a
maximum of $700,000 to be raised in gross proceeds from the sale
of up to 7,000,000 shares.
During 1994, the following equity transactions occurred: The
Company issued a total of 1,431,590 shares of common stock for
services; the Company issued a total of 1,125,834 shares of common
stock to certain prior purchasers of common stock in recognition
of disparity in purchase in contemporaneous offerings. Also during
1994, a total of $680,040 was received in cash for 6,800,499
shares subscribed as a result of the offering. Subsequent to the
offering, an additional $316,860 was received in cash from foreign
investors subscribing to 3,168,600 shares of common stock. On
December 28, 1994, the Company settled a dispute regarding the
validity of notes payable to former management in the amount of
$2,033,628 by agreeing to issue 11,250,000 common shares (recorded
as shares subscribed) in satisfaction of the total amount of the
debt.
Also in 1994, $40,000 of notes payable (a portion of loans
totaling $60,000) together with interest, was satisfied by issuing
416,500 shares of common stock.
During 1995, the following equity transactions occurred: The
Company issued a total of 2,050,000 shares of common stock for
services. $911,825 was received from investors subscribing to
9,118,260 shares of common stock. Also, 7,524,860 common shares,
previously recorded as shares subscribed, were issued, and
1,242,727 were retired in accordance with the settlement agreement
with former management. 200,000 of redeemable shares were
converted into common stock. The Company sold shares of its New
Zealand subsidiary for aggregate proceeds of $150,000.
During 1996, the Company received stock subscription agreements
for the purchase of 7,254,470 shares of its common stock, together
with proceeds totaling $725,447 from sales of its securities to
non-United States investors, outside of the United States pursuant
to Regulation S promulgated under the Securities Act of 1993.
Approximately $635,447 of these proceeds were from the sale of the
Company=s common stock at a per share price of $0.10 (including
$37,500 for 375,000 shares from Richard G. Soloman, at the time a
director of the Company). The remaining $90,000 were from the sale
of 900,000 units, each unit consisting of one share of the
Company=s common stock at a per share price of $0.10 to a director
pursuant to the non-public offering exemption from registration
under the Securities Act. In May 1996, the Company issued 600,000
shares of its common stock to employees and 250,000 shares of its
common stock to its public relations consultant as additional
compensation. The Company also issued 565,875 shares of its common
stock to various consultants for services rendered.
F-28
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 5 - ISSUANCE OF COMMON STOCK AND WARRANTS (Continued)
During 1997, the Company issued 3,089,680 previously subscribed
shares of its common stock and also issued 3,746,336 shares of its
common stock to various consultants for services rendered. Also in
1997, the Company received $400,000 for subscriptions to acquire
5,714,285 shares of its common stock and warrants to purchase
9,285,715 shares of common stock at $0.07 per share, 25,000,000
shares at $0.20 per share, and 33,333,333 shares at $0.15 per
share.
During 1998, the Company issued 5,714,286 previously subscribed
shares of its common stock and also issued a total of 4,265,000
shares of its common stock to various individuals for services
rendered. Also in 1998, the Company issued 857,142 shares of
common stock through exercise of outstanding warrants at $0.07 per
share for a total of $60,000, and issued 1,832,377 shares in lieu
of outstanding debt of $126,418. The Company also canceled 630,000
shares for services that were never performed.
During 1999, the Company issued 25,000 shares of its common stock
to an individual for services rendered valued at $1,750. In
addition, the Company issued 936,507 shares of its common stock
through the exercise of outstanding warrants at $0.07 per share
for a total of $65,555.
As of December 31, 1999, the following warrants were outstanding:
<TABLE>
<CAPTION>
Warrants Exercise Price Termination Dates
<S> <C> <C> <C>
7,492,066 $ 0.07 April 30, 2000
33,333,333 $ 0.15 April 30, 2000
25,000,000 $ 0.20 April 30, 2000
</TABLE>
NOTE 6 - NOTES PAYABLE
<TABLE>
<CAPTION>
Notes payable consisted of the following at December 31, 1999:
<S> <C>
Notes payable to ten stockholders, due on demand, plus interest at
10% per annum (in arrears). The Company is obligated to accept
the rate at face value plus accrued interest as partial payment
for shares the lender may purchase from the Company upon exercise
of the lender=s option to acquire shares from the Company. $ 60,815
Notes payable to directors totaling $28,000 and a note payable to
a third party in the amount of $9,000, due on April 22, 1995
(principal and accrued interest in arrears as of report date),
plus interest ranging from 8% to 9% per annum. Each lender has
the right to convert any portion of the principal and interest
into common stock at a price per share equal to the price per
share under the most recent private
placement transaction. 37,000
Balance Forward $ 97,815
-----------------
</TABLE>
F-29
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 6 - NOTES PAYABLE (Continued)
<TABLE>
<CAPTION>
<S> <C>
Balance Forward $ 97,815
Notes payable to directors and a family member of a director, due
at various dates in 1995, 1996 and 1997 (principal and accrued
interest in arrears as of report date), plus interest at 8% per
annum. The Company has the right to repay the loans with
restricted stock at $0.10 per share if alternative financings
do not occur. 182,676
Total Notes Payable 280,491
Less: Current Portion (280,491)
-----------------
Long-Term Notes Payable $ -
=================
</TABLE>
The aggregate principal maturities of notes payable are as
follows:
<TABLE>
<CAPTION>
Year Ended
December 31, Amount
<S> <C> <C>
2000 $ 280,491
2001 -
2002 -
2003 -
2004 -
2005 and thereafter -
-----------------
Total $ 280,491
=================
</TABLE>
F-30
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 7 - STOCK OPTIONS
All options are exercisable for a period of five years beginning
one year from the date of grant. Compensation expense, measured as
to the excess of the estimated fair value over the exercise price,
was accrued over the service period. If, on the date of exercise,
the estimated fair value of a share of the Company=s common stock
exceeded the exercise price, the exercise price was decreased by a
like amount (but not below the par value of $0.001). At the end of
each fiscal period, total accrued compensation was recorded as the
difference between the adjusted exercise price and the fair market
value at the end of the period for all exercisable shares. The
total accrued compensation was adjusted each year for changes in
the fair market value of the Company=s stock and for option
exercises and cancellations. The shares issued in connection with
the exercise of the options were restricted shares to be held for
investment purposes only.
In 1995, as part of their employment agreements, the Company's
president and chief executive officer, and vice-president and
chief financial officer and treasurer were granted options to
purchase an aggregate of 4,500,000 shares of the Company's common
stock at an exercise price of $0.20 per share, which vested fully
on January 1, 1998. The fair value of each option grant is
estimated on the grant date using an option-pricing model with the
following weighted-average assumptions used for grants in 1995:
risk-free interest rate of 6%, and expected lives of 3 years of
the options.
The following is a summary of option transactions:
<TABLE>
<CAPTION>
Weighted
Average
Exercise
Fixed Options Shares Price
------------- ----------------- -----------------
<S> <C> <C>
Balance - January 1, 1996 4,500,000 $ 0.20
Granted - -
Exercised - -
Forfeited - -
----------------- -----------------
Balance - December 31, 1996 4,500,000 0.20
Granted - -
Exercised - -
Forfeited (3,000,000) -
----------------- -----------------
Balance, December 31, 1997 1,500,000 0.20
Granted - -
Exercised - -
Forfeited - -
----------------- -----------------
Balance, December 31, 1998 1,500,000 0.20
Granted - -
Exercised - -
Forfeited (1,500,000) -
----------------- -----------------
Balance, December 31, 1999 - $ -
================= =================
</TABLE>
F-31
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 8 - PRIOR PERIOD ADJUSTMENTS
The Company has restated its financial statements to reflect
adjustments to write off liabilities which were accrued and
expensed in years prior to fiscal 1992. These adjustments
increased previously reported accumulated deficit and reduced
previously reported results of operations (for the period January
31, 1986, date of inception, through December 31, 1994) by
$219,422. During the first quarter of 1995, the Company recorded a
further reduction to accumulated deficit in the amount of $71,806
relating to the cancellation of shares previously issued to former
management.
NOTE 9 - REDEEMABLE COMMON STOCK
On February 12, 1993, per a settlement agreement, the Company
issued 200,000 shares of restricted common stock to an unrelated
third party. According to the agreement, if the Company files a
registration statement for an offering of its securities, it must
use its best efforts to include such shares in the registration
statement. If all, or any portion of the shares have not been
purchased by the Company or all the shares have not been covered
by an effective registration, then the Company shall be required
to pay, no later than April 13, 1995, an amount equal to the
lesser of $50,000 minus the aggregate purchase price amount
payable under the formula set forth in the agreement, or $25,000.
In September 1995, the Company paid $5,000 and issued 200,000
shares of restricted common stock in full and final settlement of
the agreement.
NOTE 10 - GOING CONCERN
The Company's consolidated financial statements are prepared
using generally accepted accounting principles applicable to a
going concern which contemplates the realization of assets and
liquidation of liabilities in the normal course of business. The
Company has historically incurred significant losses which have
resulted in an accumulated deficit of $14,019,621 at December 31,
1999 which raises substantial doubt about the Company's ability
to continue as a going concern. The accompanying consolidated
financial statements do not include any adjustments relating to
the recoverability and classification of asset carrying amounts
or the amount and classification of liabilities that might result
from the outcome of this uncertainty.
Continuation of the Company as a going concern is dependent upon
obtaining additional capital, obtaining the requisite approvals
from the FDA and/or the EU for the marketing of ozone-related
products and equipment, and ultimately, upon the Company's
attaining profitable operations. The Company will require a
substantial amount of additional funds to complete the
development of its products, to establish manufacturing
facilities, to build a sales and marketing organization and to
fund additional losses which the Company expects to incur over
the next several years.
F-32
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 10 - GOING CONCERN (Continued)
Because ozone-generation for the purposes of interfacing with
blood and blood products is regarded as a new drug delivery
system, the Company is precluded from selling or distributing its
drug or the Medizone Technology in the United States until after
FDA approval has been granted. In order to obtain FDA approval,
the Company will be required to submit a New Drug Application
("NDA") for review by the FDA and provide medical and scientific
evidence sufficient to demonstrate that the drug and the Medizone
Technology has been successfully used in pre-clinical studies
followed by three phases of well-controlled clinical studies
using human volunteer subjects. The FDA will not grant an NDA
unless it contains sufficient medical evidence and data to permit
a body of qualified and experienced scientists to conclude that
the new drug product is safe and effective for its recommended
and proposed medical uses. Historically, the FDA has held a
strong bias against treating humans with ozone, due largely to
issues of safety.
In order to initiate the first phase (i.e., Phase I) of human
clinical trials required as part of an NDA, an applicant must
submit to the FDA an application for an Investigational New Drug
Exemption ("IND"), which contains adequate information to satisfy
the FDA that human clinical trials can be conducted without
exposing the volunteer human subjects to an unreasonable risk of
illness or injury. The Company submitted an IND application
(assigned to the Company by its former president) to the FDA on
October 6, 1985, and requested FDA approval to commence human
clinical trials using ozone-oxygen to inactivate HIV. The FDA
deemed the IND application to be incomplete, and required the
Company to conduct additional animal studies prior to commencing
a large animal study and human trials. In September 1994, after
not receiving responses to requests for information from the
Company, the FDA inactivated the Company's IND. The Company has
no present plans to commence a large animal study, which would
require, as a precursor, additional small animal and laboratory
work. Accordingly, there can be no assurance that the Company'
IND application will ever be reopened. Until an NDA had been
granted to the Company, it may not distribute ozone-generating
devices, except to researchers who agree to follow FDA
guidelines, and provided the devices are labeled as
"Investigational Devices."
Because ozone has been used to treat humans in Europe for at
least 30 years, the EU is more accepting of human clinical trials
of ozone therapies being conducted than is the United States.
Accordingly, management believes that the Company should pursue
the option of conducting human clinical trials in Europe, using
stringent protocols that will meet EU standards, with a view to
utilizing the results of such a trial in an effort to obtain EU
approval, to market the product in Europe and to reopen the
Company=s FDA file.
The management of the Company intends to seek additional funding
which will be utilized to fund additional research and continue
operations. The Company recognizes that, if it is unable to raise
additional capital, it may find it necessary to substantially
reduce or cease operations.
F-33
<PAGE>
MEDIZONE INTERNATIONAL, INC. AND SUBSIDIARY
(A Development Stage Company)
Notes to the Consolidated Financial Statements
December 31, 1999
NOTE 11 - SUBSEQUENT EVENTS
Subsequent to December 31, 1999, the following events occurred:
1. On January 27, 2000, warrants to purchase 3,142,857 shares of
common stock were exercised at $0.07 per share for $220,000.
2. On January 18, 2000, the board of directors granted the
following shares of common stock in lieu of accrued salaries
at December 31, 1999: a) 750,000 shares to the Company's
C.E.O., valued at $75,000, b) 750,000 shares to the Company=s
President and Director of Research, valued at $75,000, c)
420,000 shares to the Company's C.O.O. and Corporate
Secretary, valued at $42,000, d) 70,000 shares to the
Company's C.F.O., valued at $7,000, and e) 100,000 shares to
a member of the board of directors of the Company, valued at
$10,000.
3. On February 8, 2000, the Company consummated an agreement
which provided for the release of $39,577 in old debt to an
unrelated party for consideration of $15,000 cash and 20,000
shares of the Company's common stock valued at $3,500,
resulting in a gain on settlement of debt of $21,077 for the
year ended December 31, 1999.
4. On February 18, 2000, the Company consummated an agreement
which provided for the release of $67,933 in old debt to an
unrelated party for consideration of $27,500 cash, resulting
in a gain on settlement of debt of $40,433 for the year ended
December 31, 1999.
5. On February 22, 2000, the Company consummated an agreement
which provided for the release of $90,893 in old debt to an
unrelated party for consideration of $45,000 cash and 100,000
shares of the Company=s common stock at a market value of
$18,000. However, pursuant to the agreement, if the value of
the Company=s common stock within the next 90 days is lower
that $1.00 per share, the Company would guarantee the
difference. Therefore, no gain on settlement of debt has been
recorded for the year ended December 31, 1999 since the
ultimate liability has not yet been determined.
6. On January 25, 2000, a former officer of the Company was
charged with fraud perpetrated upon the Company in past
years. The former officer was forced to pay restitution to
the Company in the amount of $415,869 under a plea bargain
that dropped all felony charges against the former officer
except for one count of grand larceny in the second degree.
The amount will be recorded as miscellaneous income during
the year ended December 31, 2000.
F-34
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> YEAR
<FISCAL-YEAR-END> DEC-31-1999
<PERIOD-END> DEC-31-1999
<CASH> 4,388
<SECURITIES> 0
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 4,388
<PP&E> 10,625
<DEPRECIATION> 4,958
<TOTAL-ASSETS> 10,055
<CURRENT-LIABILITIES> 1,202,906
<BONDS> 280,491
0
0
<COMMON> 149,888
<OTHER-SE> (1,192,851)
<TOTAL-LIABILITY-AND-EQUITY> 10,055
<SALES> 0
<TOTAL-REVENUES> 0
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 275,253
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 22,439
<INCOME-PRETAX> (236,182)
<INCOME-TAX> 0
<INCOME-CONTINUING> (236,182)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (236,182)
<EPS-BASIC> 0
<EPS-DILUTED> 0
</TABLE>
