SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 10-K
|X| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the fiscal year ended JANUARY 31, 1999
Commission file number: 1-8366
POLYDEX PHARMACEUTICALS LIMITED
(Exact Name of Registrant as Specified in Its Charter)
Commonwealth of the Bahamas None
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(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
421 Comstock Road, Toronto, Ontario, Canada M1L 2H5
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (416) 755-2231
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class Name of Each Exchange on Which Registered
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Common Shares, $.016 Par Value Boston Stock Exchange
Securities registered pursuant to Section 12(g) of the Act: SAME
Indicate by check mark whether the Registrant: (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
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Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of Registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. |X|
The aggregate market value of the Registrant's voting stock held by
non-affiliates of the Registrant, computed by reference to the average bid and
ask prices of such stock as of March 31, 1999: $5,537,777.50.
The number of Common Shares outstanding as of March 31, 1999: 3,016,917.
Documents Incorporated By Reference
Portions of the Registrant's Annual Report to Shareholders for the fiscal year
ended January 31, 1999, are incorporated by reference into Part II.
Portions of the Registrant's definitive Proxy Statement for the Annual Meeting
of Shareholders to be held on June 24, 1999, are incorporated by reference into
Part III.
PART I
ITEM 1. BUSINESS
INTRODUCTION
Polydex Pharmaceuticals Limited (the "Registrant") was incorporated
under the laws of the Commonwealth of the Bahamas on June 14, 1979 as Polydex
Chemicals Limited, and changed its name on March 28, 1984. The address of its
statutory office in the Bahamas is c/o Higgs & Johnson, 83 Shirley Street,
Nassau, Bahamas: telephone (242) 322-8571. The Registrant's current business
is conducted through two of its subsidiaries, Polydex Chemicals (Canada)
Limited, a wholly-owned Canadian corporation incorporated in 1969, which
itself conducts its business through its wholly-owned subsidiary, Dextran
Products Limited ("Dextran Products") (incorporated in Ontario in 1966) and
Chemdex, Inc. ("Chemdex"), a 90% owned Kansas corporation incorporated in
1987. On November 30, 1992, Chemdex acquired from Continental Grain Company
100% of the issued and outstanding share capital of Veterinary Laboratories
Inc. ("Vet Labs"), a Kansas corporation, which previously had been
wholly-owned by the Registrant. On December 1, 1992, Vet Labs and Sparhawk
Laboratories Inc. ("Sparhawk") entered into a joint venture (the "Sparhawk
Joint Venture") for the purpose of manufacturing and selling veterinary
pharmaceutical products. Sparhawk is an affiliated company owned primarily by
the management of the Sparhawk Joint Venture. The Registrant controls the
Sparhawk Joint Venture through its control of the board of directors. On May
9, 1995, the Registrant acquired from its then Chairman (now Vice-Chairman),
Thomas C. Usher, a 90% interest in Novadex International Inc. ("Novadex
International"), a Bahamian corporation. The Registrant acquired the
remaining 10% interest in Novadex International from an unaffiliated third
person on July 14, 1997. The principal asset of Novadex International is a
patent, developed by Mr. Usher, for the use of Cellulose Sulphate in a number
of applications including the development of a new contraceptive gel.
GENERAL
The current business of the Registrant is the manufacture and sale
of Dextran and several of its derivatives, including Iron Dextran and Dextran
Sulphate, veterinary pharmaceutical products and other specialty chemicals,
and cosmetic raw materials, with some related research and development.
Dextran, a generic name applied to certain synthetic compounds
formed by bacterial growth on sucrose, is a polymer or giant molecule. The
name Polydex combines the words "polymer" and "dextran."
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DESCRIPTION, USAGE AND REGULATED ASPECTS OF THE PRODUCTS
The operations of the Registrant are presently carried on through
Dextran Products and Vet Labs. These subsidiaries operate in two industry
segments: the manufacture and sale of veterinary pharmaceutical products and the
manufacture and sale of Dextran and derivatives.
IRON DEXTRAN
A. DESCRIPTION
Iron Dextran is a derivative of Dextran produced by complexing Iron
with Dextran. Iron Dextran is injected into most pigs at birth as a treatment
for anemia.
B. REGULATION AND USAGE
Sales presently are being made by the Registrant in the following
countries, which have approved the use of Iron Dextran for animals, require no
approval, or accept the Canadian registration: Canada (registration number
R625), Denmark, France, Switzerland, Hong Kong, Germany, the Netherlands,
Finland, Ecuador, Thailand, Hungary, Italy, Malaysia, the Philippines, Japan,
Brazil, Korea, Spain, Sweden, Israel, New Zealand, Mexico, Costa Rica, and
Australia. In the United States, sale for veterinary use requires the approval
of the U.S. Food and Drug Administration (the "FDA"). Chemdex has FDA approval
for veterinary use of Iron Dextran in the United States. For classification
purposes, the Registrant treats these sales of the Iron Dextran raw materials as
sales of Iron Dextran.
DEXTRAN SULPHATE
A. DESCRIPTION
Dextran Sulphate is a specialty chemical which finds use in research
applications of the pharmaceutical industry and other centers of chemical
research.
B. REGULATION AND USAGE
The Dextran Sulphate manufactured by the Registrant is sold in
Australia, Switzerland, France, the Netherlands, New Zealand and the United
States, where it is used in limited quantities in the manufacture of film, as
well as analytical chemical applications. This usage requires no regulatory
approval.
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VETERINARY PRODUCTS
A. DESCRIPTION
The Registrant manufactures sterile injectable products, tablets and
boluses, internal and external solutions, ointments and powders.
B. REGULATION AND USAGE
The products are sold in the United States and are predominantly used
by large animal veterinarians and by farmers for the treatment of various
diseases and conditions that affect farm animals. The Vet Labs facility is
regulated and inspected by the FDA and the U.S. Drug Enforcement Agency.
SALES, DISTRIBUTION AND RELIANCE UPON FOREIGN COUNTRIES
IRON DEXTRAN AND DEXTRAN SULPHATE
The Registrant sells Iron Dextran on an exclusive basis in certain
countries and on a non-exclusive basis elsewhere. Dextran Sulphate is sold on a
non-exclusive basis throughout the world. For the fiscal year ended January 31,
1999, no single customer accounted for 10% or more of total sales.
The Registrant has not changed its mode of distribution of Iron Dextran
or Dextran Sulphate during the past twelve fiscal years. The Registrant sells
its product primarily to independent distributors and wholesalers throughout the
world. Orders are forwarded to the Registrant's manufacturing facilities in
Toronto, Ontario, Canada where they are processed and shipped. The Canadian
Embassies and Consulates in various countries also assist the Registrant by
making available information regarding the Registrant and its products.
VETERINARY PRODUCTS
All of the sales of Vet Labs for the fiscal year ended January 31, 1999
were within the United States. Distribution is achieved through private label
buying groups who then distribute to their own distributors, and through full
service independent distributors who purchase products under Vet Labs' house
labels. Private label products accounted for approximately 81% of sales with
house label sales contributing approximately 15%. In addition, Vet Labs also
does "contract filling" for other industry companies. Four customers (all
private label buying groups) accounted for 66% of sales at Vet Labs, with
individual customer shares ranging from less than 1% to 21%. Management does not
believe that the loss of any one or more of these customers would have a
material adverse effect upon Vet Labs' results of operations.
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WORKING CAPITAL REQUIREMENTS
There are no special inventory requirements or credit terms extended to
customers that would have a material adverse effect upon the Registrant's
working capital.
PATENTS, TRADEMARKS AND LICENSES
IRON DEXTRAN
Effective February 1, 1995, the Registrant entered into an agreement
with Novadex Inc., an affiliated company, whereby Novadex Inc. granted the
Registrant the exclusive worldwide license to use a certain process developed by
Novadex Inc. for producing Iron Dextran. This process allows the Registrant to
produce Iron Dextran at a lower cost than would otherwise be possible. The term
of the license agreement is 10 years. The Registrant pays a license fee based on
production volumes. Upon the expiration of the license, the technology relating
to the process described above will belong to the Registrant, with no further
obligation to make royalty payments to Novadex Inc.
The technology in the field of Dextran and its derivatives is
undergoing continuous expansion and development. The manufacture of Dextran and
its derivatives may be achieved by different processes and variations (including
glycoside, which is in the public domain). Therefore, the Registrant does not
believe that the license agreement described above gives it any substantial
competitive advantage.
DEXTRAN SULPHATE
This material was patented under U.S. patent number 4,855,410 in
August, 1989 and has been tested with other drugs for efficacy in controlling
the HIV virus. At this time research has been halted so that the Registrant can
focus its resources on projects relating to cystic fibrosis and Cellulose
Sulphate. Once these projects have been completed, the Registrant expects to
return its attention to Dextran Sulphate.
VETERINARY PRODUCTS
Vet Labs holds a New Animal Drug Application from the FDA for the
production of 10% Bulk Iron Hydrogenated Dextran. In addition, Chemdex holds a
Drug Master File for the manufacture of 10% Injectable Iron Hydrogenated Dextran
which makes it the only approved source of Bulk Iron in the United States.
ELASTIN AND COLLAGEN
These materials were patented under U.S. patent numbers 4,659,740 and
4,784,986 on April 21, 1987 and November 15, 1988, respectively. The patents
cover a process whereby the materials are modified in such a way as to penetrate
the skin and act as a hydrating agent.
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CELLULOSE SULPHATE
During the fiscal year ended January 31, 1996, a patent for a new
method of manufacture of Cellulose Sulphate was purchased for $1 million. The
process was patented under U.S. patent number 5,378,828 in June of 1995. Prior
to development of the patented process the manufacture of the compound required
the use of dangerous and environmentally sensitive chemicals. The new method is
safer, and appears to produce a more consistent product. This material appears
to have applications in film manufacture and capsule production and is presently
being investigated in conjunction with the Rush Institute of the University of
Chicago as a potential contraceptive which also has antiviral capabilities. With
regard to the latter application, the Registrant is looking to perform human
clinical trials and to this end most of the animal toxicology work necessary for
the filing of an Investigation New Drug (IND) has been completed. The IND will
be filed when all of the work is complete.
CYSTIC FIBROSIS
Effective April 1, 1994, the Registrant entered into a Research
Agreement (the "UBC Research Agreement") with an affiliated company and the
University of British Columbia ("UBC"). On April 1, 1996, the UBC Research
Agreement was amended and expanded to include a number of Canadian hospitals.
Under the terms of the UBC Research Agreement, the Registrant has agreed to
provide equipment and funding in return for continuing research on cystic
fibrosis to be carried out in connection with two patents issued in 1996. U.S.
patent number 5,441,938 is held jointly by UBC and the Registrant, whereas U.S.
patent number 5,514,665 is held by UBC and licensed to the Registrant. In
conjunction with the UBC Research Agreement, UBC granted the Registrant, through
a sub-licensing agreement with an affiliated company, an exclusive worldwide
license to manufacture, distribute and sell products derived or developed from
the research performed. The Registrant will pay a quarterly royalty, based on
sales.
STATUS OF NEW PRODUCTS OR INDUSTRY SEGMENTS
There has been no public announcement of, and no information otherwise
has been made public about, a new product or industry segment that would require
the investment of a material amount of the assets of the Registrant or that
otherwise is material.
SUPPLIERS AND SALES
IRON DEXTRAN AND DEXTRAN SULPHATE
With regard to its basic raw materials, the Registrant utilizes one
basic supplier for its sugar requirements and one basic supplier for its Iron.
Both of these materials, as well as others used by the Registrant, are readily
available from numerous suppliers at competitive prices in the market. The
Registrant has no long-term contracts with any of its suppliers.
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The Registrant is dependent upon a single source for a certain raw
material used in the production of Dextran Sulphate. Such supply was adequate in
fiscal 1999 and no shortages are anticipated in the near term. However, any
curtailment in availability of such raw material could be accompanied by
production or other delays as well as increased raw material costs, with
consequent adverse effect on the Registrant's results of operations.
VETERINARY PRODUCTS
Raw materials are readily available from a variety of suppliers at
competitive prices in the market. The Registrant has no long-term contracts with
any of its suppliers.
BACKLOG AND SEASONALITY
The Registrant's backlog as at January 31, 1999 was approximately
$800,000, whereas backlog as at January 31, 1998 was approximately $1,000,000.
All of these orders are expected to be filled within the current fiscal year.
The Registrant's business is not seasonal to any material extent.
COMPETITION
The Registrant is the only Canadian manufacturer of Iron Dextran and,
as a result of its acquisition of Vet Labs, the Registrant is also the only
manufacturer of the 10% Bulk Solution in the United States. There exist several
European sources of Iron Dextran. However, the only other major supplier of Iron
Dextran is located in Denmark. Dextran Sulphate is also manufactured by several
manufacturers in the U.S. and Europe. With regard to Iron Dextran and Dextran
Sulphate, the Registrant competes on the basis of quality, service and price.
The Registrant currently produces approximately 50 veterinary products
including analgesics, anti-diarrheals, topical antiseptics, nutritional
supplements, local and general anesthesia agents and euthanizing agents. Primary
market segments include beef and dairy cattle, swine, equine and to a small
extent, companion animals (dogs and cats). With the exception of Iron Dextran
and Nitrofurazone ointment, the product offering is generic or non-licensed (non
NADA). As such, all products are subject to numerous competitors. In addition to
competing on the basis of quality, service and price, the Registrant
differentiates itself from competitors through its ability to supply multiple
product dosage forms (i.e., injectables, boluses, tablets, liquids and powders)
and provide customers with technical and regulatory support and assistance from
in-house quality control and regulatory departments.
RESEARCH AND DEVELOPMENT
During the fiscal years ended January 31, 1999, 1998, and 1997, the
Registrant expended $33,063, $184,901 and $92,063, respectively, on research and
development relating primarily to cystic fibrosis and Cellulose Sulphate. The
fiscal 1999 decrease is due to the recognition of investment tax credits of
$201,762, as a result of the continued profitability of Canadian
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operations. Total cash outlays for research and development were $234,825 in
fiscal 1999 before taking into account the investment tax credit recognition.
ENVIRONMENTAL COMPLIANCE
The Registrant believes that it is in substantial compliance with all
existing applicable foreign, federal, state and local environmental laws and
does not anticipate that such compliance will have a material effect on its
future capital expenditures, earnings or competitive position.
GOVERNMENTAL CONTRACTS
No portion of the Registrant's business is subject to renegotiation of
profits or termination of contracts or subcontracts at the election of the U.S.
Government.
EMPLOYEES
As of March 31, 1999, the Registrant employed 79 employees, of whom 53
were engaged in production, 14 in quality control, 2 in research and
development, 7 in administration and 3 in marketing and sales activities. Of
such employees, 54 were employed by Vet Labs and 25 by Dextran Products. None of
the Registrant's employees are covered by collective bargaining agreements.
Management considers its relations with employees to be good.
RECENT DEVELOPMENTS -- NEW PRODUCTS
ACTIVATED COLLAGEN AND ELASTIN
Collodex, a modified collagen, has been formulated as a principal
ingredient of a cosmetic skin cream. During fiscal 1999, the Registrant engaged
several marketing companies for the promotion of this product. To date, efforts
by these companies have met with limited success. At the present time, minor
sales are being made to cosmetic manufacturers in the Pacific Rim with the
potential for increased sales in the future.
Elastin, a material with similar applications, has been developed by
the Registrant. It has not been commercialized, however, and no sales are
expected to occur in the current fiscal year.
CYSTIC FIBROSIS
Cystic fibrosis is a genetic disease which causes a cascade of effects,
the most severe being a build up of mucus in the lungs. This mucus is difficult
to remove and also permits the colonization of bacteria which then cause
secondary infections and often death. Research relating to cystic fibrosis is
underway in collaboration with the University of British Columbia where in vitro
studies are being performed. This research has shown that a special form of
Dextran, Usherdex 4, is effective in preventing the colonization of bacteria in
the mouth and in stimulating the macrophages in the lungs to remove the bacteria
present and lessen secondary
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infections. The Registrant is in preliminary discussions with certain companies
about financing or forming an alliance to further this research through clinical
trials and to market, however, the results of their discussions are
indeterminable at this time. Further animal work is being planned prior to the
commencement of human clinical trials.
CELLULOSE SULPHATE
Production of this product was halted in 1989 when the customer found a
substitute. However, interest in the industrial use of Cellulose Sulphate has
been revived and samples have been supplied, but it is difficult to predict if
sales will occur this year. As discussed above, research is also underway in the
United States to evaluate the use of this material as a contraceptive gel with
antiviral capabilities. The Registrant is currently in preliminary discussions
with certain companies to fund the further research necessary to commercialize
this Cellulose Sulphate product, however, the results of these discussions are
indeterminable at the present time.
SEGMENTED INFORMATION
The information regarding the geographic distribution of revenue,
operating results and assets set forth in Note 15 to the Registrant's
Consolidated Financial Statements included in the Registrant's Annual Report to
Shareholders for the fiscal year ended January 31, 1999 is incorporated herein
by reference.
ITEM 2. PROPERTIES
The Registrant's wholly-owned subsidiary, Polydex Chemicals (Canada)
Limited, maintains its executive and sales offices and its manufacturing plant
of approximately 30,000 square feet in Toronto, Ontario, Canada.
The Registrant operates a fermentation plant in Toronto, Ontario,
Canada, having the capacity to produce both 10% and 20% Iron Dextran at the rate
of up to 10,000 litres a week (there are 1.057 quarts in one litre). Present
production is approximately 8,000 litres a week. Complexing of the Iron Dextran
takes place in Toronto, Ontario, Canada.
Dextran Sulphate presently is manufactured at the Registrant's plant in
Toronto, Ontario, Canada where reactors and spray drying equipment are
available. The Registrant presently manufactures approximately 500 kilos of
Dextran Sulphate per quarter (there are 2.2 pounds in one kilo), and has the
capacity to manufacture 500 kilos per month simultaneously with the 10,000
litres per week of Iron Dextran.
The Registrant has submitted engineering drawings in connection with
the planned refurbishment of the Toronto facility to the relevant governmental
authorities for approval. A building permit has been issued and further review
is now being performed by a GMP consultant.
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A scope of work has been developed and it is anticipated that equipment will
begin to be purchased and installed in the second quarter of fiscal 2000.
Through its subsidiary Vet Labs, the Registrant manufactures tablets
and boluses, internal and external solutions, ointments, powders and injectable
products. The manufacturing facility is located on 8 acres of land in Lenexa,
Kansas. The plant is 55,000 square feet with separate production areas for each
of the above product groups. The plant has the capacity to manufacture over
200,000 boluses per day, 4,000 gallons of liquids per day, 1,500 pounds of
powder per day and 1,000 gallons of injectable products per day. Although the
facility is currently running at approximately 50% of capacity, warehouse space
is limited. The Registrant intends to commence construction of additional
warehouse space on the existing property in the second quarter of fiscal 2000.
Each of the properties described above is owned by the Registrant.
Management believes that the Registrant's facilities are adequate for its
present requirements. These facilities have additional capacity for expansion of
production of existing and new products. The Registrant considers its current
equipment to be in good condition and suitable for the operations involved.
ITEM 3. LEGAL PROCEEDINGS
On May 23, 1996, FMMG, Inc. ("FMMG") filed suit against the Registrant
in the United States District Court for the Southern District of Florida seeking
damages for the alleged breach of an option given by the Registrant in favor of
FMMG and another company with respect to 160,000 shares of common stock in
Novatek International, Inc. previously held by the Registrant. The Registrant
intends to vigorously defend the action. However, it is not possible at this
point in time to accurately predict the likelihood of an unfavorable outcome or
the magnitude of any potential damages.
There are no other material pending legal proceedings other than
ordinary routine litigation incidental to the business, to which the Registrant
or any of its subsidiaries is a party, or to which any of the their property is
subject.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of security holders, through the
solicitation of proxies or otherwise, during the Registrant's fourth quarter
ended January 31, 1999.
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PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED
SHAREHOLDER MATTERS
The information contained under the caption "Market for the Company's
Common Stock and Related Security Holder Matters" in the Registrant's Annual
Report to Shareholders for the fiscal year ended January 31, 1999 is
incorporated herein by reference.
The following information is provided in addition to the information
incorporated by reference as mentioned above.
There are no governmental laws, decrees or regulations in the
Commonwealth of the Bahamas applicable to the Registrant that restrict the
export or import of capital, including foreign exchange controls, or that affect
the remittance of dividends or other payments to nonresident holders of the
Registrant's Common Shares. Furthermore, U.S. holders of the Registrant's Common
Shares are not subject to taxes under Bahamian law.
ITEM 6. SELECTED FINANCIAL DATA
The information required under this item is included under the caption
"Financial Highlights" in the Registrant's Annual Report to Shareholders for the
fiscal year ended January 31, 1999 and is incorporated herein by reference.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
The information required under this item is included under the caption
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" in the Registrant's Annual Report to Shareholders for the fiscal
year ended January 31, 1999 and is incorporated herein by reference.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
The information required under this item is included under the caption
"Qualitative and Quantitative Disclosures About Market Risk" in the Registrant's
Annual Report to Shareholders for the fiscal year ended January 31, 1999 and is
incorporated herein by reference.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The Registrant's Consolidated Financial Statements are included in the
Registrant's Annual Report to Shareholders for the fiscal year ended January 31,
1999 and are incorporated herein by reference. Supplementary financial
information is not required.
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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
The information required under this item is incorporated herein by
reference from the material contained under the captions "Board of Directors,"
"Proposals,""Executive Officers" and "Section 16(a) Beneficial Ownership
Reporting Compliance" in the Registrant's definitive proxy statement to be filed
with the Securities and Exchange Commission pursuant to Regulation 14A, not
later than 120 days after the end of the fiscal year.
ITEM 11. EXECUTIVE COMPENSATION
The information required under this item is incorporated herein by
reference from the material contained under the captions "Board of Directors,"
"Board Meetings and Committees," "Compensation of Executive Officers,"
"Employment Agreements" and "Company Stock Performance" in the Registrant's
definitive proxy statement to be filed with the Securities and Exchange
Commission pursuant to Regulation 14A, not later than 120 days after the end of
the fiscal year.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT
The information required under this item is incorporated herein by
reference from the material contained under the caption "Ownership of Voting
Securities" in the Registrant's definitive proxy statement to be filed with the
Securities and Exchange Commission pursuant to Regulation 14A, not later than
120 days after the end of the fiscal year.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information required under this item is incorporated herein by
reference from the material contained under the caption "Transactions With the
Company" in the Registrant's definitive proxy statement to be filed with the
Securities and Exchange Commission pursuant to Regulation 14A, not later than
120 days after the end of the fiscal year.
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PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON
FORM 8-K
(a) The following documents are filed as a part of this Annual Report
on Form 10-K:
(1) Financial Statements included in the Registrant's
Annual Report to Shareholders for the fiscal year
ended January 31, 1999 and incorporated by reference
from Exhibit 13 filed herewith
Auditors' Report to the Shareholders -- Ernst & Young LLP
Chartered Accountants
Consolidated Balance Sheets
Consolidated Statements of Shareholders' Equity
Consolidated Statements of Operations
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
(2) Financial Statement Schedules
Schedules for which provision is made in the
applicable accounting regulation of the Securities
and Exchange Commission are not required under the
related instructions or are inapplicable, and
therefore, have been omitted.
(3) Exhibits
3.1 Memorandum of Association of Polydex
Pharmaceuticals Limited, as amended (filed
as Exhibit 3.1 to the Annual Report on Form
10-K filed April 30, 1997, and incorporated
herein by reference)
3.2(a) Articles of Association of Polydex
Pharmaceuticals Limited, as amended (filed
as Exhibit 3.2 to the Quarterly Report on
Form 10- Q filed September 9, 1997, and
incorporated herein by reference)
3.2(b) Certificate of Amendment to the Articles of
Association of Polydex Pharmaceuticals
Limited, as amended
10.1 Employment Agreement between Polydex
Pharmaceuticals Limited and Thomas C. Usher
dated December 22, 1993, as amended on
November 1, 1996 (filed as Exhibit 10.1 to
the Annual Report on Form 10-K filed April
30, 1997, and incorporated herein by
reference)*
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10.2 Amendment to Employment Agreement between
Polydex Pharmaceuticals Limited and Thomas
C. Usher dated February 1, 1999*
10.3 Employment Agreement between Polydex
Pharmaceuticals Limited and George G. Usher
dated December 22, 1993 (filed as Exhibit
10.2 to the Annual Report on Form 10-K filed
April 30, 1997, and incorporated herein by
reference)*
10.4 Amendment to Employment Agreement between
Polydex Pharmaceuticals Limited and George
G. Usher dated February 1, 1999*
10.5 Research Agreement among Dextran Products
Limited, Canadian Microbiology Consortium,
British Columbia's Children's Hospital and
the University of British Columbia, dated
April 1, 1996 (filed as Exhibit 10.4 to the
Annual Report on Form 10-K filed April 30,
1997, and incorporated herein by reference)
10.6 Joint Venture Agreement among Chemdex, Inc.,
Veterinary Laboratories Inc. and Sparhawk
Laboratories, Inc., dated December 1, 1992
(filed as Exhibit 10.5 to the Annual Report
on Form 10-K filed April 30, 1997, and
incorporated herein by reference)
10.7 Manufacturing Agreement among Sparhawk
Laboratories, Inc., Agri Laboratories, Ltd.
and Veterinary Laboratories Inc., dated
September 23, 1996 (filed as Exhibit 10.6 to
the Annual Report on Form 10-K filed April
30, 1997, and incorporated herein by
reference)
10.8 Stock Sale and Purchase Agreement between
Continental Grain Company and Polydex
Pharmaceuticals Limited dated October 30,
1992, as amended on November 22, 1996 (filed
as Exhibit 10.8 to the Annual Report on Form
10-K filed April 30, 1997, and incorporated
herein by reference)
13 Annual Report to Shareholders for the fiscal
year ended January 31, 1999 (only those
portions incorporated herein by reference)
21 Subsidiaries of Polydex Pharmaceuticals
Limited (filed as Exhibit 21 to the Annual
Report on Form 10-K filed April 30, 1997,
and incorporated herein by reference)
23 Consent of Ernst & Young LLP Chartered
Accountants
27 Financial Data Schedule
* Indicates a management contract or compensatory plan or arrangement
(b) Reports on Form 8-K
Not applicable.
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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 on Form 10-K to
be signed on its behalf by the undersigned, thereunto duly authorized.
POLYDEX PHARMACEUTICALS LIMITED
Dated April 29, 1999 By: /s/ George G. Usher
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George G. Usher, President and
Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this Annual
Report on Form 10-K has been signed below by the following persons on behalf of
the Registrant and in the capacities and on the dates indicated.
Date: April 29, 1999 /s/ George G. Usher
--------------------------------------------
George G. Usher, Director, President
and Chief Executive Officer
(Principal Executive Officer)
Date: April 29, 1999 /s/ Sharon Wardlaw
--------------------------------------------
Sharon Wardlaw, Treasurer, Secretary
and Chief Financial and Accounting
Officer (Principal Financial and
Accounting Officer)
Date: April 29, 1999 /s/ Joseph Buchman
--------------------------------------------
Joseph Buchman, Director
Date: April 29, 1999 /s/ Derek John Michael Lederer
--------------------------------------------
Derek John Michael Lederer, Director
Date: April 29, 1999 /s/ John L.E. Seidler
--------------------------------------------
John L.E. Seidler, Director
Date: April 29, 1999 /s/ Ruth L. Usher
--------------------------------------------
Ruth L. Usher, Director
Date: April 29, 1999 /s/ Thomas C. Usher
--------------------------------------------
Thomas C. Usher, Director
-15-
EXHIBIT INDEX
EXHIBIT NUMBER EXHIBIT DESCRIPTION
- -------------- -------------------
3.2(b) Certificate of Amendment to the Articles of
Association of Polydex Pharmaceuticals Limited, as
amended
10.2 Amendment to Employment Agreement between Polydex
Pharmaceuticals Limited and Thomas C. Usher dated
February 1, 1999
10.4 Amendment to Employment Agreement between Polydex
Pharmaceuticals Limited and George G. Usher dated
February 1, 1999
13 Annual Report to Shareholders for the fiscal year
ended January 31, 1999 (only those portions
incorporated herein by reference)
23 Consent of Ernst & Young LLP Chartered Accountants
27 Financial Data Schedule