Item 5 and Item 8 are the subject in a Form 12b-25.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
--------------------
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1935
For the fiscal year ended December 31, 1997
Commission File Number: 33-16757-D
MEDIZONE CANADA LIMITED (originally KPC Investments, Inc.)
- --------------------------------------------------------------------------------
(Exact name of Registrant as stated in its corporate charter)
Utah 87-0431771
- ----------------------------------------------------------------
(state of incorporation) (I.R.S. Employer I.D. Number)
4505 South Wasatch Boulevard, Suite 210, Salt Lake City 84124
- -----------------------------------------------------------------
(Address of principal executive offices) (Zip code)
Registrant's telephone number: (801) 274-8400
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act: None
The Registrant has (1) has filed all reports required to be filed by Section 13
or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the Registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90
days.
Yes X No
Disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is
contained herein, and will be contained in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment hereto. Yes No X
The aggregate market value of voting common stock held by non-affiliates of the
Registrant was $___________ on March ___, 1998, based on the average bid and
asked prices of such stock as reported on the NASD OTC Bulletin Board.
According to information received from Registrant's transfer agent, as of March
18, 1998, Registrant had 36,493,333 shares outstanding (of which 26,115,242 were
restricted).
DOCUMENTS INCORPORATED BY REFERENCE: None
SUPPLEMENTAL INFORMATION: The Registrant intends to furnish its shareholders
with n annual report for 1997 and a shareholder information statement subsequent
to the filing of the 10-K.
1
<PAGE>
TABLE OF CONTENTS
PART I Page
Item 1. Business................................................... 3
Item 2. Properties................................................ 11
Item 3. Legal Proceedings......................................... 11
Item 4. Submission of Matters to a Vote of Security
Holders................................................... 11
PART II
Item 5. Market for Registrant's Common Equity and Related
Stockholder Matters..................................... 12
Item 6. Selected Financial Data................................. 13
Item 7. Management's Discussion and Analysis of Financial
Condition and Results of Operations..................... 14
Item 8. Financial Statements and Supplementary Data............. 15
Item 9. Changes in and Disagreements with Accountants on
Auditing and Financial Disclosure....................... 15
PART III
Item 10. Directors and Executive Officers ....................... 15
Item 11. Executive Compensation.................................. 17
Item 12. Security Ownership of Certain Beneficial Owners
and Management.......................................... 18
Item 13. Certain Relationships and Related Transactions.......... 19
PART IV
Item 14. Exhibits, Financial Statement Schedules,
and Reports on Form 8-K................................. 19
Signatures.............................................. 20
Exhibits Index......................................... E-1
Financial Statements.................................... F-1
2
<PAGE>
PART I
Item 1. Business
General
Medizone Canada Limited, a Utah corporation (the "Company" or the
"Registrant") organized in 1987, is a development stage company, which is a
majority owned subsidiary of Medizone International, Inc. ("MII"). MII is a
Nevada corporation, organized in 1986. MII is itself a development stage company
whose objective is to (i) gain regulatory approval for its drug, a precise
mixture of ozone and oxygen called MEDIZNE(R), 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)
develop the related technology and equipment for the medical application of its
products, including its drug production and delivery system (the "Medizone
Technology"). MEDIZNE(R) is one of two registered trademarks of MII. Throughout
this report, whether or not the trademark symbol is used, the phrase "Medizone
(the drug)" is intended to have the same effect as if the trademark symbol had
been used.
Medizone (the drug) is intended to be used as a therapeutic drug in humans
to inactivate certain viruses, and thereby afford a treatment for certain
virally-based diseases (including Human Immunodeficiency Virus ["HIV"], the AIDS
related virus, Hepatitis B, Epstein-Barr, herpes, and cytomegalovirus), and to
decontaminate blood and blood products, applications which are covered under the
Company's patent (Patent No. 4,632,980). The Medizone Technology was developed
for the production of Medizone (the drug), and has led to the design of
equipment for which a patent has been issued in the United States (Patent No.
5,052,382). Patents based on each of these patents have been obtained in various
foreign countries. See "Patents".
The Company's objective is to gain regulatory approval in Canada for
Medizone (the drug) and to assist in the development of the Medizone Technology.
The Company's Canadian activities are carried on by its wholly owned subsidiary,
MCL Medizone Canada Ltd., a corporation organized under the laws of the Province
of British Columbia ("MedCan").
The Company's principal asset is the license granted to it and MedCan by
MII, which covers the use of MII's Canadian presently held patent and any other
patents based on the Medizone Technology which it may acquire, pursuant to a
license agreement between MII and MedCan, dated November 30, 1987 (the "License
Agreement"). See "Patents" and "License Agreement".
3
<PAGE>
Patents
The proprietary scope of MII is covered under a United States process
patent (U.S. Patent No. 4,632,980) entitled, "Ozone Decontamination of Blood and
Blood Products" (the "Patent") and a related United States equipment patent
(U.S. Patent No. 5,052,382) entitled "Approaches for the Control Generation and
Administration of Ozone" (the "Equipment Patent").
The Patent, which covers a procedure for ozone decontamination of blood
and blood products through the treatment of blood and blood components, is MII's
principal asset.
The method covered by the Patent is the principal use of ozone under
study by MII and the Company and is the method incorporated in MII's and the
Company's regulatory applications. (See "Governmental Regulation" below.) In
June 1990, pursuant to MII's request for re-examination of the Patent, the U.S.
Patent Office issued a re-examination certificate, confirming the patentability
of the claims covered by the Patent. MII's United States patent protection for
the Patent will expire in 2003, subject to extension based upon the length of
time required to bring the Patent to commercial fruition. MII was granted a
patent (based on the Patent) in Canada in 1990. This Canadian patent will expire
in 2007.
The Equipment Patent, which covers apparatus for the controlled
generation, monitoring and dosage of a precise admixture of ozone and oxygen
(Medizone, the drug), was developed by a consultant engineer to MII and issued
and assigned to MII in 1991. The Equipment Patent was developed to provide the
physical means to deploy the Patent. MII has an application pending in Canada
for a patent based upon the Equipment Patent.
In late 1996, MII became aware that a United States patent has been
issued to a Canadian corporation which MII and the Company believe infringes on
the Patent. MII has consulted its patent counsel and intends to take the
appropriate steps to protect its rights with respect to the Patent. However, at
the present time, the nature of any action to be taken by MII would be limited
by the lack of funding.
The License Agreement
By agreement dated November 30, 1987, MII granted to MedCan the exclusive
right in Canada, under the patent issued in Canada based upon the Patent and any
other patent thereafter issued in Canada relating to the Patent, the Equipment
Patent or the Medizone Technology, to make, use and sell Medizone (the drug) and
any therapy embodied in the Canadian patents. MedCan is required, pursuant to
the License Agreement, without cost or expense to MII, to implement or cause the
implementation of, research studies, to test the efficacy of Medizone (the drug)
and the Medizone Technology in the treatment of Hepatitis B, various animal
viruses and other viruses, diseases and conditions existing in Canada. The
License Agreement shall remain in effect until the expiration of the last patent
licensed thereunder, subject to early termination by either party in the event
of a material default. The License Agreement does not provide for the payment of
a royalty to MII.
4
<PAGE>
Research and Development
Neither the Company nor MII maintain laboratories or other clinical
research or testing facilities. MII's research and development activities have
been conducted by utilizing contract laboratories and clinicians. The research
and development activities have been directed by MII's Scientific Advisory
Board, whose sole member since June 1997 has been Dr. Gerard V. Sunnen, MII's
Director of Science.
Pre-clinical Studies
Pre-clinical Studies are defined as non-human studies. Since 1988, MII has
both sponsored and been the beneficiary of research to determine, among other
things, (i) whether the use of ozone, either alone or with other modalities, is
efficacious in the treatment of certain diseases and (ii) to establish
additional scientific evidence that ozone, through the use of the patents and/or
applications of scientific methodologies of a similar nature can decontaminate
blood of lipid enveloped viruses and thereby significantly diminish the degree
of transfusion related disease.
Pre-clinical projects sponsored by MII to date include: (1) studies to test
ozone's ability to inactivate HIV, conducted at the State University of New York
("SUNY") 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
MII 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 arm of the Canadian Blood Forces Program discontinued funding the
program. MII's current management learned in late 1997 that the program, as it
involves the Medizone Technology, was stopped primarily due to an equipment
failure and the generation of erroneous data due to the equipment failure. The
third stage of the study was resumed in May 1996, but did not utilize the
Medizone Technology.
(Balance of page intentionally left blank.)
5
<PAGE>
Governmental Regulation
Medizone (the drug), the Medizone Technology and any related products
derived therefrom are regulated in the United States under the Federal Food,
Drug and Cosmetic Act and the regulations promulgated thereunder (the "FDC Act")
and are regulated by the Food and Drug Administration (the "FDA") and, in
Canada, are regulated by the Canadian Department of Health and Welfare (the
"CDHW"). The FDA and the CDHW exercise broad and extensive authority in
regulating the development, production, importation, distribution and promotion
of "new drug" products and "investigational devices".
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 Medizone (the drug) or the Medizone
Technology pursuant to the License Agreement until after CDHW approval has been
granted. In order to obtain CDHW approval, the Company will be required to
submit medical and scientific evidence sufficient to demonstrate that Medizone
(the drug) and the Medizone Technology has been successfully used in
pre-clinical studies followed by well-controlled clinical studies using human
volunteer subjects. The CDHW will not grant its approval unless it receives
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.
In order to commence human trials, the Company will be required to submit
an application to the CDHW which contains adequate information to satisfy the
CDHW that known clinical studies can be conducted without exposing the volunteer
subjects to an unreasonable risk of illness or injury while indicating some
potential for clinical efficacy.
The Company has submitted an application to the CDHW to commence human
clinical trials, which was placed on clinical hold pending further studies on
animal toxicity and other studies. The Company's ability to commence such
additional studies is dependent on it receiving additional funding.
In obtaining regulatory approval in Canada, the Company will be provided
with all information developed by MII and, accordingly, will be assisted by
steps taken by MII to obtain regulatory approval in the United States. In that
regard, MII will be required to obtain regulatory approval from the Federal Food
and Drug Administration (the "FDA"), which regulates the development,
production, importation, distribution and promotion of "drug" products and
"investigational devices" pursuant to the FDC Act.
To obtain FDA approval, MII will be required to submit a New Drug
Application ("NDA") to the FDA which will have to continue evidence that
Medizone (the drug) and the Medizone Technology have been successfully used in
human clinical studies. Historically, the FDA has held a strong bias against
treating humans with ozone due largely to issues of safety.
6
<PAGE>
In order to initiate the first phase (i.e., Phase I) of human clinical
studies 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 studies can be
conducted without exposing the volunteer human subjects to an unreasonable risk
of illness or injury. MII submitted an IND application (assigned to the
Registrant 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 MII 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 MII, the FDA inactivated MII's IND. MII 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
MII's IND application will ever be re-opened. Until an NDA has been granted to
MII, 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 European Union (the "EU") is more accepting of human clinical trials
of ozone therapies being conducted than is the United States. Accordingly, MII's
management believes that MII 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 trials in an effort to
obtain EU approval and to re-open MII's FDA file.
Clinical Studies
Overview
--------
To date MII has not performed any human clinical studies.
The Italian Initiative
----------------------
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. In this regard, the Italian Ministry
of Health designated the Italian Scientific Society for Ozone-Oxygen Therapy in
Bergamo, Italy ("ISSOT") as the agency to select 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, with ISSOT, MII 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
MII on a site by site basis. The ISSOT letter agreement requires MII 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 MII's efforts to re-open the FDA
IND (see "Governmental Regulation").
7
<PAGE>
On May 16, 1994, MII announced that human trials were to commence at the
University of Naples ("Naples"). However, after the termination of Joseph S.
Latino's employment with MII, MII's inquiry into the conduct of its operations
during Dr. Latino's tenure as its Chairman, President and Chief of Research
disclosed that human trials of MII'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. MII 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
MII to conduct Phase II trials, they would require MII to have either completed
a large animal study and Phase I trials or to have these requirements waived.
MII has never performed a large animal study or Phase I 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.
MII 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 MII
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 MII's ozone
technology on humans in lieu of having MII perform a large annual study and
possibly even a Phase I clinical study. The ICRO would also design a research
program and protocols for clinical trials which would meet the standards of the
EU and FDA, monitor the clinical terms and collect and prepare analyses of the
data produced by the trials. MII will not be able to enter into a formal
contract with 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, MII will be required to perform its own Phase I clinical trials and
possibly a large animal study. In late 1997, MII entered into a discussions with
Italian and Belgium clinicians with regard to them performing Phase I clinical
studies. However, assuming the Italian Ministry of Health did not grant MII's
request for a waiver, no formal agreements with these clinicians would be signed
and the studies would not begin until MII obtains additional funding. MII
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 study and submission of the data for approval to the Italian Ministry
of Health.
The Company's ability to commercially market products is dependent on
obtaining CDHW approval. The Company believes that, at least even if CDHW
approval was obtained, the process will encompass several years. In addition,
the Company believes that research costs incident to obtaining CDHW approval
will be significant and will require the Company to obtain additional infusions
of capital.
Instrument Development
On October 17, 1996, MII executed an agreement with Multiossigen, S.r.L.,
an Italian corporation located in Bergamo, Italy (the "Manufacturer"), dated as
of September 13, 1996 (the "Equipment Contract"), providing for the manufacture
of ozone generating devices to be used in the human trials to be commenced
pursuant to MII's letter agreement with the ISSOT, as trials are approved by the
Italian Ministry of Health.
8
<PAGE>
Pursuant to the Equipment Contract, the Manufacturer has produced a working
prototype of ozone generating devices dedicated to the use of hollow fibers or
similar gas exchange technology covered under MII's patents, satisfactory to MII
(the "Equipment"), and will make all data generated from the use of the
Equipment available to MII. The Equipment Contract calls for the Manufacturer to
manufacture twenty pieces of the Equipment at a purchase price of $9,000 per
unit, for an aggregate of $180,000, payable as follows:
(a) $25,000, paid upon approval of the prototype;
(b) $55,000, payable in fifteen installments of $3,667 with five
such installments ($18,335) being paid on each delivery of
five units of the Equipment; and
(c) one million shares of MII's common stock, bearing a
restrictive legend,500,000 shares of which were issued on the
date the Equipment Agreement was executed with the remaining
500,000 shares issued on March 16, 1997.
Pursuant to the Equipment Agreement, MII granted to the Manufacturer a
license to use MII's patents in Europe, subject to the regulations of all
documents necessary to protect MII s rights in and to the patents, and appointed
the Manufacturer as MII's exclusive manufacturer and distributor of the
Equipment in Europe. Notwithstanding the forgoing, the present distribution of
the Equipment shall be limited to Italy, but such distribution will be expanded
to the rest of Europe upon the mutual agreement of the parties.
The Equipment Agreement (together with its grants of license and
distribution described above) will terminate on September 13, 1998 and may be
renewed by mutual agreement of the partners at least thirty days prior to the
end of its term.
Units of Equipment shall be delivered in lots of five units and shall be
deliverable to the appropriate hospital site within 60 days of the written
request by the Company, based upon such hospital's ethics committee granting
approval to committee trials at a particular site.
Since its organization, the Company has attributed $29,554 as expenditures
for research and development, including $0 in 1996.
Common Stock Purchase Warrants
Four million redeemable common stock purchase warrants, each exercisable to
purchase one share of the common stock of the Company for $.125, are
publicly-held. The Company's warrants originally had a nine-month exercise
period, but the expiration date was extended numerous times until December 31,
1997.
9
<PAGE>
Competition
The area in which the Mill and the Company seeks to do business is
extremely competitive. The Company is aware of a number of domestic companies
that have commenced research into the use of ozone as a virucide in the
treatment of HIV and other diseases, or 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. The Company is also aware that
another company has provided ozone-generating equipment to departments of the
Canadian government conducting studies in Canada for the purposes of comparison
of technologies. In addition, as reported in scientific journals and newspapers,
there are many commercial, not-for-profit and governmental agencies
investigating possible treatments for HIV and other viral diseases, as well as a
variety of methodologies aimed toward blood fractionate decontamination.
Employees and Consultants
The Company has three employees, its President, its Vice-President/Chief
Financial Officer and a Vice President of Operations (who is not an officer of
the Company). These individuals serve in the same capacities for MII.
MII has established a Scientific Advisory Board, which also serves the
Company, which suggests and formulates avenues of research and reviews research
in progress. As of December 31, 1996 the Scientific Advisory Board was comprised
of two members, Joseph S. Latino, Ph.D., then the Company's President and Chief
Executive Officer, and Bernard J. Poiesz, M.D., Head, Regional Oncology Center,
S.U.N.Y. at Syracuse, Syracuse, New York. The Scientific Advisory Board met
three times in 1996. Dr. Poiesz was not compensated by the Company or MII for
his services on the Scientific Advisory Board, although he has applied for
research grants in connection with MII's and the Company's research and
development efforts. Dr. Poiesz became a member of the Scientific Advisory Board
in 1987. From 1989 to 1995, Fred Quimby, D.V.M., Ph.D., Chairman, Animal
Research Institute, New York State School of Veterinarian Medicine, Cornell
University, was a member of the Scientific Advisory Board, but resigned when he
became the sole principal investigator for the SIV Study being conducted under
the auspices of the Canadian Blood Forces Program. See "Research and
Development".
In June 1997, the Scientific Advisory Board was reorganized. It currently
has one member, Dr. Gerard V. Sunnen, who serves as MII's Director of Science.
Insurance
The Company presently has no product liability insurance, since none of its
products are in clinical use. There is presently no officers and directors
liability insurance in effect for either of MII or the Company's officers and
directors.
10
<PAGE>
Item 2. Properties.
----------
The Company's offices are provided by MII at no charge.
Item 3. Legal Proceedings.
-----------------
None.
Item 4. Submission of Matters to a Vote of Security Holders.
---------------------------------------------------
No matters were submitted to a vote of securities holders during the fourth
quarter of the year ending December 31, 1997.
Certain Business Risks Associated with the Company
Development Stage Company/Net Losses
------------------------------------
Although the Company was incorporated in 1987, it is still in the
development stage and has not yet commenced full operations, nor has it earned
any revenues. No assurance can be given that its business activities will ever
result in profitable operations generate revenues. As indicated in the Company's
financial statements, it has experienced substantial losses throughout its
history. Such losses can be expected to continue for the foreseeable future.
No Revenues/Need for Additional Financing by Parent
---------------------------------------------------
The Company has generated no revenues, and is dependent upon the results of
MII's research. MII similarly has had no revenues and has had no source of funds
other than through the sale of its common stock and will require substantial
additional capital, which will most likely be obtained through sales of its
common stock, in order to continue the research program. No assurances can be
given that MII 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 MII's administrative and operating expenses for any
significant period of time.
Status of MII's Research
------------------------
MII's research has not progressed to a point where it would be appropriate
to predict when, if ever, Medizone (the drug) and the Medizone Technology would
have commercial application or be marketable.
11
<PAGE>
Forward-Looking Information May Prove Inaccurate
This Form 10K/A contains forward-looking statements and information that
are based on management's beliefs as well as assumptions made by and information
currently available to management. When used in this document, the words
"anticipate," "believe," "estimate," and "expert," and similar expressions are
intended to identify forward-looking statements. Such statements reflect the
Company's current views with respect to future events and are subject to certain
risks, uncertainties and assumptions, including the specific risk factors
described above. Should one or more of these risks or uncertainties materialize,
or should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. The Company
does not intend to update these forward-looking statements and information.
Part II
Item 5. Market for Registrant's Common Equity and
Related Stockholder Matters.
-----------------------------------------
Prices/Trading Market Information
The Company's shares are traded in the over-the-counter market, with price
quotes listed on the NASD Electronic Bulletin Board under the trading symbol
"MZNC," and in the "pink sheets" published by the National Quotation Bureau.
On March ___, 1998, according to the NGB Non-NASDQ Price Report
furnished by the National Quotation Bureau, there was one marketmaker submitting
quotations in the Company's shares, and the average of the high and low bids for
the shares was $ . Such 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.
Shown below is information obtained from the National Quotation Bureau,
indicating the high bid and low bid prices for a share of the Company's common
stock at the end of each of the four calendar quarters of fiscal 1996 and 1997,
representing prices between dealers which do not include retail markup, markdown
or commission. They do not reflect actual transactions.
Bid Price
Calendar Period High Low
--------------- ---- ---
1996 First Quarter .02 .02
Second Quarter .05 .03
Third Quarter .04 .02
Fourth Quarter .025 .02
1997 First Quarter
Second Quarter
Third Quarter
Fourth Quarter
12
<PAGE>
Number of Holders
On March 18, 1998, according to the Company's transfer agent, there were
223 holders of record of the Company's par value $.001 common stock.
Dividends
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. 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, in
order to finance research and development.
Item 6. Selected Financial Data.
-----------------------
<TABLE>
<CAPTION>
Year Ended
December 31,
------------
1997 1996 1995 1994 1993
---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C>
Operations Data:
Revenues $-0- $-0- $-0- $-0- $-0-
Net (loss) (1744) (3,301) (3,553) (3,617) (32,357)
Net loss) -0- - 0 - -0- -0- -0-
per common share
Weighted average 36,493,000 36,493,000 36,493,000 36,493,000 36,493,000
common shares out-
standing
Balance Sheet
Data:
Working capital $(10,898) $(11,498) $(11,498) $(13,498) $(21,919)
(deficiency)
Total assets -0- - 0 - -0- -0- -0-
Long-term -0- - 0 - -0- -0- -0-
liabilities
Accumulated (223,188) (221,444) (218,143) (214,590) (210,973)
(deficit)
Stockholders' (10,898) (11,498) (11,498) (13,498) (21,919)
equity
(deficiency)
</TABLE>
13
<PAGE>
Item 7. Management's Discussion and Analysis of Financial
Condition and Results of Operations.
-------------------------------------------------
Results of Operations
Registrant's financial statements in prior years reflected advances to its
parent company (MII) in the amount of $142,287 as bad debt expense because of
the uncertainty of repayment of those advances. After consideration of the facts
surrounding the advances, the Registrant restated its financial statements to
reverse the bad debt expense and to reflect the financial statements as though
the transaction was an equity investment rather than a loan arrangement.
The effect of this restatement was to decrease additional paid-in capital
and the deficit accumulated during development stage.
Years ended December 31, 1997 and December 31, 1996.
---------------------------------------------------
Research and development expenses in 1997 were $-0- and were $-0- in 1996.
General and administrative expenses in 1997 consisted of accounting fees of
$1,400 and other miscellaneous expenses of $344.
General and administrative expenses in 1996 consisted of accounting fees of
$2,000, legal fees of $652 and other miscellaneous expenses of $649.
Net cash used in operating activities was $2,344 in 1997 as compared to
$3,301 in 1996. The decrease was due to decreased general and administrative
expenses.
Cash provided by financing activities decreased in 1997 to $2,344 as
compared to $3,301 in 1996. These amounts represent capital received from the
parent company, MII.
Years ended December 31, 1996 and December 31, 1995.
Research and development expenses in 1996 were $-0- and were $-0- in 1995.
General and administrative expenses in 1996 consisted of accounting fees of
$2,000, legal fees of $652 and other miscellaneous expenses of $649.
General and administrative expenses in 1995 consisted of accounting fees of
$2,000 and other miscellaneous expenses of $1,553.
Net cash used in operating activities was $3,301 in 1996 as compared to
$5,553 in 1995. The decrease was due to decreased general and administrative
expenses.
Cash provided by funding activities decreased in 1996 to $3,301 as compared
to $5,553 in 1995. These amounts represent capital received from the parent
company, MII.
Liquidity and Capital Resources
At December 31, 1997, Registrant had a working capital deficiency of
$10,898 and a stockholders' deficiency of $10,898. At December 31, 1996,
Registrant had a working capital deficiency of $11,498 and a stockholders'
deficiency of $11,498.
Registrant will continue to require additional capital in order to gain the
necessary regulatory approvals. There is no assurance that such capital will be
raised. If adequate funding cannot be obtained, Registrant may be required to
substantially reduce or cease operations.
Registrant has outstanding warrants to purchase 4,000,000 shares of common
stock at $.125 per share, the expiration date which had been extended to
December 31, 1997, at which date they expired.
14
<PAGE>
Item 8. Financial Statements and Supplementary Data.
-------------------------------------------
The financial statements and supplementary data are listed under Item 14 in
this Annual Report and commence on page F-1.
Item 9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure.
------------------------------------------------
None.
PART III
Item 10. Directors and Executive Officers of Registrant.
----------------------------------------------
On July 7, 1996, at the Company's annual meeting, Joseph S. Latino, George
Handel and John D. Pealer were elected to the Company's Board of Directors.
On May 14, 1997, MII's Board of Directors terminated the employment of
Joseph L. Latino ("Latino") as MII's President and Chairman after the discovery
of a pattern of unaccounted for expenditures of the MII's funds. MII is
investigating the purposes, nature and extent of such expenditures. Dr. Latino
remained a Director of MII and the Company until he resigned from these
positions in July 1997. George Handel ("Handel") was named President and
Chairman and served as such until May 19, 1997 when Kenneth Gropper ("Gropper")
assumed these positions.
Contemporaneously with the above events, MII was notified that The Sand
Dollar Solution, a California limited partnership ("Sand Dollar"), whose general
partner is Edwin G. Marshall ("Marshall"), was soliciting shareholder proxies to
vote for Marshall, Milton G. Adair ("Adair"), Gerard V. Sunnen, M.D. ("Sunnen")
and William M. Hitt, Ph.D., M.D. ("Hitt") as Directors.
On June 12, 1997, MII's Board of Directors appointed Marshall, Adair,
Sunnen and Hitt, to MII's Board of Directors, with Marshall being named
Chairman. Contemporaneously thereto, John Pealer ("Pealer") resigned as a
Director, and Gropper resigned as President. The Board thereupon made the
following appointments to the following positions:
President and
Chief Executive
Officer - Adair
Chief Operating
Officer - Gropper
Secretary - Sunnen
The Board also named an Executive Committee, composed of Marshall, Adair,
Gropper, Sunnen and Hitt. The remaining Directors were Latino and Handel;
however, during the Board meeting, Handel resigned from the Board, effective
June 13, 1997 and Latino subsequently resigned from the Board of MII and the
Company in July 1997.
15
<PAGE>
On December 8, 1997, the Company's Board of Directors appointed Adair as a
Director. Following this action, John D. Pealer resigned as a Director and
Marshall was appointed a Director. On January 5, 1998, Handel resigned as a
Director and Sunnen was named to replace him. Contemporaneously with these
events, Adair was named President and Chief Executive Officer of the Company.
The following table sets forth certain information concerning the Registrant's
directors and officers, as of December 31, 1997.
Director Officer Positions with
Name Age Since Since Registrant
- ---- --- -------- ------- --------------
Edwin G. Marshall 55 1997 Director
Milton G. Adair 65 1997 1997 President, Chief
Executive Officer and
Director
Gerard V. Sunnen 55 1997 1997 Secretary and Director
Arthur P. Bergeron 47 1992 Vice President, Treasurer
and Chief Financial
Officer
Edwin G. Marshall became a Director of the Company in December 1997. He's
Chairman of the Company's parent, MII. He attended Santa Rosa Junior College and
the College of Marin, in California, studying Business and Fire Science.
Marshall served for 17 years in the fire service, rising to become Captain of
the Richmond, California Fire Department. He left the fire service in 1979 to
enter the real estate business. He participated in the real estate business as
the owner of Smith, Smith & Associates, in Truckee, California, from 1979 to
1984, and as a broker with TRI Realtors, in the San Francisco Bay Area, from
1987 to 1990. Marshall was employed by Future Technology Marketing, Inc., of
Truckee, California, in sales and training from 1985 to 1987. In 1989, Marshall
co-founded The Marin Car Company, which was in the automobile and truck sales
and leasing business, in Novato and Petaluma, California. In 1992, Marshall left
The Marin Car Company. He is currently employed as a private investor and is
also the general partner of Sand Dollar.
Milton G. Adair became the Company's President, Chief Executive Officer and
a Director in December 1997. He holds the same positions with MII. He received a
Bachelor of Arts degree in Business Administration and Psychology from The
College of the Pacific in 1955. After employment by Shell Oil Company and
Pittsburgh Des Moines Steel from 1955 to 1963, Mr. Adair was employed by Pfizer
Incorporated from 1963 to 1978 in several capacities, culminating in his
position as Director of Sales for the Pfizer Diagnostics division. From 1978 to
1979, Mr. Adair was employed as Vice President-Sales/Marketing for the Becton
Dickinson Immunodiagnostics division of Becton Dickinson Corporation ("BD") in
Orangeburg, New York. Thereafter, until 1983, he was Vice-President and General
Manager of Becton Dickinson Automated Immunochemistry division of BD in Salt
Late City, Utah. From 1983 to 1984, Mr. Adair was President of Orbit Medical
Systems, Inc., a Salt Lake City venture capital company in the immunochemistry
field. Mr. Adair was President, Chief Executive Officer and a Director of
Mountain Medical Equipment, Inc., in Littleton, Colorado, whose stock was traded
on the American Trade Exchange (the "AMEX"), from 1984 to 1991. In 1991, he
became President and Chief Executive Officer of Gull Laboratories, Inc. ("Gull
Labs"), in Salt Lake, and whose stock trades on the AMEX, and which is in the
business of supplying diagnostic kits and automated equipment in the infectious
disease and autoimmune markets. He remained at Gull Labs until 1995 and became
President and Director of Biomune Systems, Inc. ("Biomune") until 1997. Biomune,
whose stock is traded on the NASDAC system, is a bio-technology company that is
developing pharmaceutical products for the treatment of cryptosporidioses and E.
Coli.
16
<PAGE>
Gerard V. Sunnen, M.D. became Secretary and a Director of the Company in
January 1998. He holds the same positions with MII. 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. He have also written
on the medical applications of ozone.
Arthur P. Bergeron became Vice President, Treasurer and Chief Financial
Officer of the Company in 1992. He holds these same positions with MII. He
received a Bachelor of Science in Accounting from Bentley College in Waltham,
Massachusetts in 1973 and a Master of Science in Taxation from Bentley College
in 1980. Mr. Bergeron is a certified public accountant and is the principal of
Arthur P. Bergeron & Co., P.C., in Wellesley, Massachusetts, a public accounting
firm which he founded in 1978. Mr. Bergeron does not devote his full time to the
affairs of the Company.
Item 11. Executive Compensation.
----------------------
Directors Compensation
None of the directors received any compensation for serving as a director
in 1996.
Executive Compensation
The officers of the Company do not receive any compensation from the
Company. Its president, vice president/chief financial officer and secretary are
compensated by MII. The following table sets forth the compensation paid by MII
to Joseph S. Latino, the Company's past President and Chief Executive Officer in
1995 and 1996, Milton Adair its current President and Chief Executive Officer in
1997, and Arthur P. Bergeron, the Company's Vice-President, Treasurer and Chief
Financial Officer for the 1995, 1996 and 1997 fiscal years.
Summary Compensation Table
---------------------------
<TABLE>
<CAPTION>
Long Term
Annual Compensation Compensation
------------------- ------------
Name and Principal Other Annual
Position Compensation
- ------------------ ------------
Year Salary Bonus Options #
---- ------ ----- ---------
<S> <C> <C> <C> <C> <C>
Joseph S. Latino, Ph.D., 1996 $180,000 -0- (1)
President and Chief 1995 $180,000 -0- (1) 3,000,000
Executive Officer
Milton G. Adair, 1997 $200,000 -0- -0- 3,000,000(2)
President and Chief
Executive Officer
Arthur P. Bergeron, Vice 1997 $ 72,000(3) - 0 - (4) 1,500,000
President, Treasurer and 1996 $ 72,000(3) - 0 -
Chief Financial Officer 1995 $ 72,000 - 0 -
</TABLE>
17
<PAGE>
Employment Agreements
The Company does not have employment agreements with its officers. MII has
employment agreements with Dr. Latino and Mr. Bergeron pursuant to which they
are to serve as officers of the Company without additional compensation. Dr.
Latino's employment agreement was terminated for cause in May 1997.
---------------
1 In 1995 and 1996, Dr. Latino was reimbursed for certain automobile expenses
and other business expenses, in the amounts of $33,222 and $45,642,
respectively. In 1995 and 1996, MII provided Dr. Latino with health
insurance, paying premiums in the amounts of $9,438 and $10,380,
respectively.
2 On December 16, 1997, Mr. Adair was granted options to purchase 3,000,000
shares of MII's Common Stock pursuant to the MII's 1997 Qualified Stock
Option Plan (the "Option Plan"). The options vest at the rate of 500,000
shares every six months and, once vested, may be exercised over a period of
ten years at a price equal to the Common Stock's market value at the date
of grant ($.06). The Option Plan will be submitted to a shareholder vote at
MII's 1997 annual meeting.
3 In 1996, due to MII's financial condition, Mr. Bergeron received only
$36,000 of his salary. He has not received payment of his salary in 1997.
4 In 1995, 1996 and 1997, MII provided Mr. Bergeron with health insurance,
paying premiums of $9,438, $10,380, and $2,595 (until April 18, 1997, when
MII's group health plan was cancelled.
Compensation Committee and Insider Participation
The Company does not have a compensation committee. Matters concerning
the compensation of executive officers are determined by the Company's Board of
Directors. Dr. Latino, who is an executive officer of the Company, is also a
member of the Company's Board of Directors and will participate in deliberations
concerning executive officer compensation, but will not vote on his own
individual compensation. However, his participation in such deliberations gives
rise to a conflict of interest which could affect his compensation.
BOARD OF DIRECTORS
Edwin G. Marshall
Milton G. Adair
Dr. Gerard V. Sunnen
Item 12. Security Ownership of Certain Beneficial Owners and
Management.
---------------------------------------------------
The following table sets forth certain information as of March 18, 1998,
pertaining to the beneficial ownership of Common Stock, by (i) persons known to
the Company to own 5% or more of the outstanding Common Stock, (ii) each
director and executive officer of the Company as of December 31, 1997 and (iii)
all directors and executive officers of the Company as a group.
18
<PAGE>
Number of Shares Percentage of Total
Name and Address Beneficially Owned Outstanding
Medizone International, Inc. 24,304,560 66.6%
4505 South Wasatch Boulevard
Suite 210
Salt Lake City, Utah 84124
Arthur P. Bergeron -0-
4505 South Wasatch Boulevard
Suite 210
Salt Lake City, Utah 84124
Edwin G. Marshall -0-
4505 South Wasatch Boulevard
Suite 210
Salt Lake City, Utah 84124
Milton G. Adair -0-
4505 South Wasatch Boulevard
Suite 210
Salt Lake City, Utah 84124
Dr. Gerard V. Sunnen 333,333 (*)
4505 South Wasatch Boulevard
Suite 210
Salt Lake City, Utah 84124
All present directors 333,333 (*)
and executive officers
as a group (4 persons)
- ---------------
(*) Indicates less than 1%.
Item 13. Certain Relationships and Related Transactions.
----------------------------------------------
None.
PART IV
Item 14. Exhibits, Financial Statement Schedules, Reports on
Form 8-K.
---------------------------------------------------
(a) See Index to Consolidated Financial Statements and Schedules
on Page F-1.
(b) None.
(c) See Index to Exhibits on page E-1.
(d) None.
19
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the Registrant has duly caused this Annual Report to be
signed on its behalf by the undersigned, thereunto duly authorized.
MEDIZONE CANADA LIMITED
By: s\Milton G. Adair
--------------------
Milton G. Adair
President
Date: March 30, 1998
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, this Annual Report has been signed below by the following
persons on behalf of the Registrant, in the capacities shown and on the date
indicated:
Date: March 30, 1998 s\Milton G. Adair
-----------------------------------
Milton G. Adair, President
Chief Executive Officer
and Director
Date: March 30, 1998 s\Arthur P. Bergeron
-----------------------------------
Arthur P. Bergeron,
Vice President, Treasurer and
Chief Financial Officer
Date: March 30, 1998 s\Edwin G. Marshall
-----------------------------------
Edwin G. Marshall, Director
Date: March 30, 1998 s\Gerard V. Sunnen
-----------------------------------
Gerard V. Sunnen, Director
<PAGE>
Exhibits and Financial Statement Schedules
------------------------------------------
The following Exhibits form a part of this Annual Report on Form 10-K:
Exhibit
Number Description of Exhibit
- ------- ----------------------
2 Agreement and Plan of Reorganization dated December 23, 1988.1
3(a) Articles of Incorporation of Registrant.2
3(b) By-laws of Registrant.2
3(c) Articles of Amendment to Registrant's Articles of Incorporation.1
10(a) Agreement made and entered into as of November 30, 1987 between
Medizone International, Inc. and MCL Medizone Canada Ltd.2
10(b) 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.3
16 Letters re: change in certifying accountants.3
- -----------------------
(1) Incorporated by reference to the Registrant's current report on Form 8K,
reporting an event that occurred on December 23, 1988
(2) Incorporated by reference to an exhibit filed as Registrant's registration
statement on Form S-18, effective December 14, 1987
(2) Incorporated by reference to the Registrant's annual report on Form 10-K
for the period ended December 31, 1994.
E-1
