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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-KSB
/X/ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES AND
EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED JUNE 30, 1998
/ / TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934
For the transition period from to
COMMISSION FILE NUMBER 000-24541
CORGENIX MEDICAL CORPORATION
(Name of Small Business Issuer in its charter)
NEVADA 93-1223466
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
12061 TEJON STREET, WESTMINSTER, COLORADO 80234
(Address of principal executive offices, including zip code)
(303) 457-4345
(Issuer's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Securities registered pursuant to Section 12(g) of the Act: COMMON STOCK,
$.01 PAR VALUE
Check whether the issuer: (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 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 / / No /X/
Check if no disclosure of delinquent filers in response to Item 405 of
Regulation S-B is contained in this form, and no disclosure will be contained,
to the best of the issuer'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. / /
The issuer's revenues for its most recent fiscal year were: $2,592,175
The aggregate market value of the voting stock held by non-affiliates of the
issuer was $ - as of September 1, 1998.
The number of shares of Common Stock outstanding was 12,027,259 as of September
1, 1998.
Transitional Small Business Disclosure Format. Yes / / No /X/
DOCUMENTS INCORPORATED BY REFERENCE
Documents Incorporated by Reference: Items 9, 10 and 11 of Part III are
incorporated by reference from the definitive proxy statement of Corgenix
Medical Corporation to be filed within 120 days after June 30, 1998.
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PART I
ITEM 1. DESCRIPTION OF BUSINESS.
CERTAIN TERMS USED HEREIN ARE DEFINED IN THE GLOSSARY THAT FOLLOWS AT THE
END OF THIS PART.
COMPANY OVERVIEW
Corgenix Medical Corporation ("Corgenix" or the "Company") is a
diagnostic biotechnology company whose principal focus has been the discovery
and development of novel diagnostic markers for the detection and management
of important immunological disorders. Until May 22, 1998, this business was
conducted by and under the name of REAADS Medical Products, Inc., a Delaware
corporation ("REAADS"). On May 22, 1998, REAADS became a subsidiary of
Corgenix, and its name was changed to Corgenix, Inc., when a wholly owned
subsidiary of the Company merged (the "Merger") with and into REAADS. In
connection with the Merger, the Company issued to the REAADS stockholders a
total of 6,120,000 shares of the Company's common stock, $.001 par value (the
"Common Stock"), together with the contingent obligation to issue up to
4,000,000 additional shares of Common Stock upon the occurrence (or
non-occurrence) of certain events. In addition, the REAADS management
assumed the management of the Company. See "Part III. Item 12. Certain
Relationships and Related Transactions -- Contingent Common Stock."
The Company was incorporated under the name Benjun Chemicals Inc. on
April 22, 1994 as a wholly owned subsidiary of Superior Equities Limited
(the "Predecessor"). The Predecessor was incorporated on April 9, 1985 under
the laws of the Province of British Columbia, Canada. In 1987 and 1991, the
Predecessor issued a total of 1,957,259 shares of its common stock in two
private placements to sophisticated investors in the Province of British
Columbia, Canada. On April 27, 1994, the shareholders of the Predecessor
exchanged all of the outstanding shares of common stock of the Predecessor on
a one-for-one basis for shares of common stock in the Company, and on March
5, 1996, the Company changed its name to Gray Wolf Technologies, Inc. ("Gray
Wolf"). During the three fiscal years prior to the Merger, Mike M.
Mustafoglu, a current director of the Company, was a director and the
president and treasurer of Gray Wolf. However, from the time of the
Predecessor's incorporation until the Merger, neither the Predecessor nor the
Company engaged in any significant business activity other than the search
for acquisition opportunities, and in the three fiscal years prior to the
Merger, the Company did not have any significant assets or liabilities.
In connection with the Merger, the Company offered and sold in a private
transaction (the "Offering") 3,950,000 shares of Common Stock for gross
proceeds of $1,000,000. The net proceeds of such sale, which were approximately
$720,000, were used by the Company to redeem certain preferred stock of REAADS
in connection with the Merger, to repay debt, to reduce accounts payable and for
working capital.
Immediately following the Merger and the Offering, the Common Stock was
held by the following groups of persons in the approximate percentages
indicated:
<TABLE>
<CAPTION>
STOCKHOLDERS(1) NUMBER OF SHARES PERCENTAGE OWNERSHIP(1)
<S> <C> <C>
Former REAADS Stockholders(2) 6,120,000 50.3%
Former Gray Wolf Stockholders 1,957,259 16.1%
Offering Stockholders 3,950,000 32.4%
</TABLE>
(1) Excludes 153,000 shares held by TransGlobal Financial Corporation ("TGF"),
a consultant to the Company, which were received by TGF in consideration of
financial advisory services provided to Gray Wolf in connection with the
Merger.
(2) Assumes that the former REAADS stockholders will not receive up to
4,000,000 shares of contingent Common Stock. Such contingent Common Stock
is issuable to the former REAADS stockholders upon the occurrence or non-
occurrence of certain events. See "Part III. Item 12. Certain
Relationships and Related Transactions -- Contingent Common Stock." If
all of such contingent Common Stock had been issued to the former REAADS
stockholders at the time of the Merger, the former REAADS Stockholders, the
former Gray Wolf Stockholders, and the Offering
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Stockholders would have held approximately 62.5%, 12.1% and 24.4% of the
outstanding shares of Common Stock, respectively.
The determination of the consideration, including the contingent Common Stock,
paid or payable to the former REAADS stockholders and the determination of the
purchase price of the Common Stock sold in the Offering was made in consultation
with the Company's and REAADS' financial advisors.
Also in connection with the Merger, the Company entered into a consulting
agreement with TransGlobal Financial Corporation ("TGF"). The president and
controlling shareholder of TGF is Mike M. Mustafoglu, who also serves as a
director of the Company. Under the terms of the consulting agreement, TGF
provides advice to the Company regarding financial and business matters,
including assistance with fundraising to implement the Company's business plans,
review and assessment of capitalization, merger and acquisition prospects, and
other transactions, on an exclusive basis. The consulting agreement is
effective for a three-year term ending May 22, 2001. TGF's fee for its
financial and business advisory services is $180,000.00 (payable in 36 monthly
installments of $5,000) plus a transaction fee equal to a percentage of any
funds committed to the Company, the value of any acquisition, or the income
generated by any joint venture, in each case to the extent that TGF assisted the
Company in obtaining such funds, acquisition or venture. See "Part III. Item
12. Certain Relationships and Related Transactions -- TGF Consulting
Agreement."
The Company's consulting agreement with TGF also requires the Company to
nominate for election two designees selected by TGF to the Company's Board of
Directors each year during the term of the agreement, and requires that there
shall be no more than five directors of the Company unless TGF consents to a
greater number. The consulting agreement also requires the Company to obtain
TGF's consent to the issuance of more than 5% of any class of its equity
securities. See "Part III. Item 12. Certain Relationships and Related
Transactions -- TGF Consulting Agreement."
The Company is also a party to an option agreement with TGF, whereby TGF
has the option to purchase 1,000,000 units, each unit comprised of one share of
the Company's authorized but unissued Series A 5% Convertible Preferred Stock
and one warrant to purchase one share of Common Stock at an exercise price of
$2.00, for an aggregate purchase price of $1,000,000. See "Part III. Item 12.
Certain Relationships and Related Transactions -- Option Agreement."
BUSINESS OVERVIEW
The Company's research program has resulted in the successful development
of 23 products currently used in clinical laboratories for the diagnosis and/or
monitoring of four important areas of health care:
- Autoimmune disorders (diseases in which an individual creates
antibodies to one's self, for example systemic lupus erythematosus
("SLE") and rheumatoid arthritis ("RA"));
- Vascular diseases (diseases associated with certain types of
thrombosis or clot formation, for example antiphospholipid syndrome,
deep vein thrombosis, stroke and coronary occlusion);
- Bone and joint diseases (such as osteoporosis and osteoarthritis); and
- Liver diseases (cirrhosis and transplanted organ rejection).
In addition to its current products, the Company is actively developing new
laboratory tests in other important diagnostic testing areas. See "-- Chugai
Strategic Relationship" and "-- Other Strategic Relationships." In this
connection, the Company manufactures and markets to clinical laboratories and
other testing sites worldwide. Its customers include large and emerging health
care companies such as Chugai Diagnostics Science ("Chugai"), a wholly owned
subsidiary of Chugai Pharmaceuticals Co., Ltd. ("Chugai Pharma"), which owns
approximately 4.6% of the Common Stock of the Company. See "-- Chugai Strategic
Relationship."
Corgenix products are based on its patented and proprietary application of
Enzyme Linked ImmunoSorbent Assay ("ELISA") technology, a clinical testing
methodology commonly used worldwide. All of the Company's current products are
based on this platform technology in a delivery format convenient for clinical
testing laboratories. The
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delivery format ("Microplate") allows the testing of up to 96 samples per
plate, and is one of the most commonly used formats, employing conventional
testing equipment found in virtually all clinical laboratories. The
availability and broad acceptance of ELISA Microplate products reduces entry
barriers worldwide for the Company's new products that employ this technology
and delivery format. Corgenix's products are sold as "kits" that include all
of the materials required to perform the test except for routine laboratory
chemicals and instrumentation. A test using ELISA technology involves a
series of reagent additions into the Microplate triggering a complex
immunological reaction in which a resulting color occurs. The amount of color
developed in the final step of the test is directly proportional to the
amount of the specific marker being tested for in the patient or unknown
sample. The amount of color is measured and the results calculated using
laboratory instrumentation. The Corgenix technology specifies a process by
which biological materials are attached to the fixed surface of a diagnostic
test platform. Products developed using this unique attachment method
typically demonstrate a more uniform and stable molecular configuration,
providing a longer average shelf life, increased accuracy and superior
specificity than the products of the Company's competitors.
Corgenix's diagnostic tests are intended to aid in the identification of
the causes of illness and disease, enabling a physician to select appropriate
patient therapy. Internally and through collaborative arrangements, the Company
is developing additional products that are intended to broaden the range of
applications for its existing products and to result in the introduction of new
products. Corgenix is specifically engaged in the development of a line of
diagnostic products that applies the ELISA technology into a different testing
format. This format involves the addition of a single patient sample into a test
system in which color is developed in a very short period of time with a minimal
number of reagents. This format, unlike the Microplate format, does not require
instrumentation and is better suited for testing outside of a typical testing
laboratory. Testing can be performed by medical personnel such as physicians and
nurses, but also can be designed so that testing can by performed directly by
the patient. This format is referred to as rapid testing ("Rapid Test") as the
results are available in only a few minutes.
Products developed in a Rapid Test format allow the prompt detection of a
variety of medical conditions. Development of this product line will enable the
Company to expand its product base beyond the conventional testing laboratory
into point of care ("POC") market segments, which include physician's office
laboratories ("POL"), and also directly to the medical consumer through retail
distribution, referred to as over-the counter ("OTC").
Since 1990, Corgenix's sales force and distribution partners have sold over
10 million tests worldwide under the REAADS label, as well as labels of other
companies under private label, or original equipment manufacture ("OEM"),
agreements. An integral part of Corgenix's strategy is to work with corporate
partners to develop market opportunities and access important resources. In this
regard, Corgenix has established strategic relationships with a number of
companies, including Chugai, Cambridge Life Sciences ("Cambridge"), a division
of Byk Gulden located in Cambridge, UK, and Helena Laboratories Corporation
("Helena"), a privately held company located in Beaumont, Texas. Corgenix
believes that its relationships with these and other potential partners will
enable Corgenix to enhance its menu of diagnostic products and accelerate its
ability to penetrate the worldwide markets for new products
The Company currently uses the REAADS trademarks and tradenames in the sale
of its products.
INDUSTRY OVERVIEW
In vitro diagnostic ("IVD") testing is the process of analyzing the
components of a wide variety of body fluids outside of the body to identify the
presence of markers for diseases or other human health conditions. The worldwide
human health IVD market consists of reference laboratory and hospital laboratory
testing, testing in physician offices and the emerging OTC market, in which
testing is done at home by the consumer.
Traditionally, diagnostic testing has been performed in large, high-volume
commercial or hospital-based laboratories using instruments operated by skilled
technicians. Corgenix products in a Microplate format are designed for such
instrumentation and are marketed to these types of laboratories. The
instrumentation and supportive equipment required to use the Corgenix ELISA
tests is relatively simple, and typically is used by a laboratory for many
different products.
One of the fastest growing segments of the human health IVD market is the
market for highly accurate tests that
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can be used logistically close to the point of patient care (such as clinics,
physician offices, homes, patient bedsides and emergency rooms) as well as in
laboratories. The growth in this POC market is primarily due to pressure on
health care providers to reduce the overall cost of health care as well as
the availability of technology that enables health care providers to process
tests on-site, rather than sending them to remote laboratories. POC testing
helps to reduce overall health care delivery costs and can improve patient
outcomes by enabling the primary caregiver to determine a diagnosis of the
medical condition during the patient's initial visit, minimizing the time to
medical intervention and reducing the need for additional patient follow-up.
The IVD industry has undergone major consolidation over the last few years.
As a result, the industry is characterized by a small number of large companies
or divisions of large companies that manufacture and sell numerous diagnostic
products incorporating a variety of technologies. In addition, there are many
small diagnostic companies, which generally have limited resources to
commercialize new products. As a result of technological fragmentation and
customer support requirements, Corgenix believes that there may be a substantial
competitive advantage for companies with unique and differentiated technologies
that can be used to generate a broad menu of diagnostic products and that have
developed successful customer support systems.
STRATEGY
Corgenix's primary objective is to apply its proprietary ELISA technology
to the development and commercialization of products for use in a variety of
markets. Corgenix's strategies for achieving this objective include the
following:
APPLY THE COMPANY'S ELISA TECHNOLOGY TO ADDITIONAL DIAGNOSTIC MARKETS.
Corgenix has focused its resources on development of highly accurate tests
in the Microplate format for sale to clinical testing laboratories. The
Company believes it can expand its market focus with the addition of new
tests complementary to the current product line.
DEVELOP A LINE OF RAPID TESTS USING THE COMPANY'S ELISA TECHNOLOGY. The
Company intends to broaden the ELISA application into a line of Rapid Tests
enabling expansion into new market areas including POC and OTC.
EXPAND INTO ADDITIONAL LARGE DIAGNOSTIC MARKET. Corgenix has focused its
product development and sales efforts on the human diagnostic market in
autoimmunity, bone and joint disease, vascular disease, and liver disease.
The Company intends to target other large indication human health
applications (such as cancer, infectious diseases and critical care
diagnostic tests) through both expanded internal research and development
efforts and collaborations with strategic partners.
LEVERAGE SALES AND MARKETING RESOURCES. Corgenix maintains a nationwide
marketing and sales organization, which is experienced in selling
diagnostic tests into the laboratory market. The Company expects to expand
this sales organization, adding distribution channels into the outpatient
market. The Company will also expand its product menu with more high value,
quality products through internal development, acquisition or in-licensing
of complementary products and technologies.
CONTINUE TO DEVELOP STRATEGIC ALLIANCES TO LEVERAGE COMPANY RESOURCES.
Corgenix has developed, and expects to continue to develop, strategic
alliances to access complementary resources (such as proprietary markers,
funding, marketing expertise and research and development assistance), to
leverage its technology, expand its product menu and maximize the use of
its sales force.
PURSUE SYNERGISTIC PRODUCT AND/OR TECHNOLOGY ACQUISITIONS. Corgenix
intends to proactively evaluate strategic acquisitions of companies,
technologies and product lines where the Company identifies a strategic
opportunity to expand its core business while increasing revenues and
earnings from these new technologies.
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PRODUCTS AND MARKETS
Corgenix and its distribution partners are currently selling ELISA tests in
major markets worldwide. To date, Corgenix's sales force and distribution
partners have sold over 10 million tests since Corgenix first received product
marketing clearance from the United States Food and Drug Administration (the
"FDA") for the first anti-cardiolipin antibody ("aCL") test in 1990. Several
peer reviewed medical publications, abstracts and symposia have been presented
on the favorable technical differentiation of Corgenix's tests over competitive
products.
To extend the product offering for current product lines, and to complement
its premium-priced, existing assays, Corgenix will continue to add products from
strategic partners. Corgenix's current product menu, commercialized under the
trademark "REAADS," includes the following:
AUTOIMMUNE DISEASE PRODUCTS
Corgenix's ELISA Autoimmune Disease Product line consists of nine products
including a screening test for antinuclear antibodies (ANA), and specific tests
to measure antibodies to rheumatoid factor, dsDNA, Sm, SM/RNP, SSA, SSB, Jo-1
and anti-Scl-70. The products are used for the diagnosis and monitoring of
autoimmune diseases including RA, SLE, Mixed Connective Tissue Disease,
Sjogren's Syndrome, Dermatopolymyositis and Scleroderma.
The Company's autoimmune disease products are formatted in the ELISA
Microplate format, and are differentiated from the competition by their user
convenience. Historically, diagnostic tests utilized antiquated technologies
that presented significant limitations for the clinical laboratory environment,
including greater labor requirements and the need for a subjective
interpretation of the results. Corgenix's ELISA Autoimmune Tests overcome these
technology shortfalls, permitting a clinical laboratory to automate its tests,
lowering the laboratory's labor costs as well as providing objectivity to test
result interpretation.
ANTIPHOSPHOLIPID ANTIBODY TESTING PRODUCTS
The Company has five products for antiphospholipid antibody testing, which
in 1997 represented over 58% of Corgenix's total product sales. These include
aCL IgG, aCL IgA, aCL IgM, anti-phosphatidylserine ("aPS") IgG and aPS IgM.
These tests are used in the diagnosis of SLE, antiphospholipid syndrome and
thrombosis. The Company has completed the development and clinical testing of
three additional test kits that detect human antibodies to B2-Glycoprotein I,
and has made Premarket Notification 510(k) submissions to the FDA with respect
to these products. Upon receipt of marketing clearance letters from the FDA,
the Company expects to manufacture, distribute and market these three new tests
to clinical laboratories worldwide.
Antiphospholipid antibodies are measured in clinical laboratories primarily
using ELISA technology with cardiolipin as the most commonly used antigen. High
levels of these antibodies are seen in venous and arterial thrombosis,
thrombocytopenia and/or recurrent abortion, now considered the main clinical
criteria for the diagnosis of a clinical entity referred to as the
antiphospholipid syndrome. The antiphospholipid syndrome may be seen in
association with an underlying disease (i.e. autoimmune such as SLE or SLE-like
disease), or may be seen in patients without any obvious or apparent disease.
When high serum levels of antiphospholipid antibodies are found in individuals
without any clinical manifestations, it is regarded as an important risk factor
for the development of antiphospholipid syndrome.
The importance of the antiphospholipid syndrome resides in its association
with serious clinical manifestations such as chronic and recurrent venous (deep
vein) thrombosis, as well as arterial thromboembolic disease including heart
attacks, strokes and pulmonary embolism. Thrombocytopenia has been attributed to
the temporary removal of platelets from circulation during a thrombotic episode
(clot formation).
VASCULAR DISEASE PRODUCTS
The Company markets seven tests for vascular diseases. Three products
(Protein C Antigen ELISA, Protein S Antigen ELISA and von Willebrand Factor
Antigen ELISA) are manufactured by Corgenix, and four others (ABP von Willebrand
Factor Activity Test, GTI Platelet Factor 4 Test, and the ABS Thrombus Precursor
Protein and Functional
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Intact Fibrinogen kits) are manufactured for Corgenix by other companies.
These products are useful in the diagnosis of certain clotting and bleeding
disorders including von Willebrand's Disease (Hemophilia B).
Hemostasis (the normal stable condition in which there is neither excessive
bleeding nor excessive clotting) is maintained in the body by the complex
interaction of the endothelial cells of blood vessels, coagulation cells such as
platelets, coagulation factors, lipids (cholesterol) and antibodies
(autoantibodies). All play important roles in maintaining this hemostasis. In
clinical situations in which an individual demonstrates excessive clotting or
bleeding, a group of laboratory tests is typically performed to assess the
source of the disorder using the tests marketed by the Company.
BONE AND JOINT DISEASE PRODUCTS; LIVER DISEASE PRODUCTS
The Company developed and manufactures the Chugai Hyaluronic Acid
("Hyaluronic Acid" or "HA") Test in a Microplate format in collaboration with
Chugai. This product is currently distributed through the Chugai distribution
network in Japan, and through the Company's United Kingdom subsidiary in the
United Kingdom, and is used in the diagnosis and monitoring of rheumatoid
arthritis and liver cirrhosis.
Hyaluronic Acid is a component of the matrix of connective tissues, found
in synovial fluid of the joints where it acts as a lubricant and for water
retention. It is produced in the synovial membrane and may leak into the
circulation via the lymphatic system where it is quickly removed by specific
receptors located in the liver. Increased serum levels of HA have been described
in patients with rheumatoid arthritis due to increased production from synovial
inflammation, and in patients with liver disease due to interference with the
removal mechanism. Patients with cirrhosis will have the highest serum HA
levels, which correlate with the degree of liver involvement.
TECHNOLOGY
The Corgenix ELISA application technology was developed to provide the
clinical laboratory with a more sensitive, specific, and objective technology
to measure clinically relevant antibodies in patient serum samples. High
levels of these antibodies are frequently found in individuals suffering from
various immunological diseases, and their serologic determination is useful
not only for specific diagnosis but also for assessing disease activity
and/or response to treatment. To accomplish these objectives, the current
Corgenix product line applies the ELISA technology in a 96-Microplate format
as a delivery system. ELISA provides a solid surface to which purified
antigens are attached, allowing their interaction with specific
autoantibodies during incubation. This antigen-antibody interaction is then
objectively measured by reading the intensity of color generated by an
enzyme-conjugated secondary antibody and a chemical substrate added to the
system.
The Corgenix technology overcomes two basic problems seen in many other
ELISA systems. First, the material coated onto the plate can be consistently
coated without causing significant alteration of the molecular structure (which
ensures maintenance of immunologic reactivity), and the stability of these
coated antigens on the surface can be maintained (which provides a product shelf
life acceptable for commercial purposes). Corgenix's proprietary immunoassay
technology is useful in the manufacture of ELISA test kits for the detection of
many analytes for the diagnosis and management of immunological diseases. This
same ELISA technology will also be applied to the Rapid Test products allowing
entry into additional market segments.
The Corgenix technology results in products demonstrating performance
characteristics that exceed those of competitive testing procedures. Many
testing laboratories worldwide subscribe to external quality control schemes or
programs conducted by independent, third- party organizations. These programs
typically involve the laboratory receiving unknown test samples on a routine
basis, performing certain diagnostic tests on the samples, and providing results
of their testing to the third party. Reports are generally provided by the third
party that tells the testing laboratory how it compares to other testing
laboratories in the program. Several of the Company's products are included in a
third-party survey periodically conducted by an unaffiliated entity, and
Corgenix's products routinely demonstrate the best standard deviation for its
products when compared to other manufacturers included in such survey.
A Corgenix product typically requires less hands-on time by laboratory
personnel and provides an objective, quantitative or semi-quantitative
interpretation to improve and standardize the clinical significance of results.
The
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Corgenix proprietary technology will continue to be the mainstay for future
Corgenix diagnostic products. Most of the products in development will
incorporate the basic Corgenix technology, even in alternate delivery formats
(including Rapid Test products).
Additional technologies may be required for some of the newly identified
tests, particularly for the POC business. Management believes that, in
additional to internal expertise, most technology and delivery system
requirements are available through joint venture or licensing arrangements or
through acquisition.
DELIVERY SYSTEMS
All of the current Corgenix products employ the Microplate delivery system
using ELISA technology. This format is universally accepted in clinical
laboratory testing and requires routine equipment currently available in most
clinical labs.
The Company is developing a line of Rapid Test products configured as
single test delivery systems. These products will be intended for testing by a
physician or other medical personnel at the patient's bedside, for example in an
emergency room setting, a general care unit, or an ICU or specialized treatment
site. In this case a sample is obtained from the patient and applied directly to
a test module so that results can be read immediately. Rapid Tests can also be
configured in a format for home testing for sale directly to the consumer
through OTC retail outlets, such as pharmacies.
SALES AND MARKETING
Corgenix currently markets and sells its products to the traditional
clinical laboratory market, both hospital based and free standing laboratories.
The Company utilizes a diverse distribution program for its products. Corgenix
labeled products are sold directly to testing laboratories in the United States
through 14 sales representatives.
Internationally, Corgenix labeled products are sold through established
diagnostic companies in Austria, Belgium, Canada, Denmark, Egypt, France,
Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Kuwait,
Mexico, Norway, Peoples Republic of China, Peru, Portugal, Saudi Arabia,
Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and the United
Kingdom. Discussions are underway that are expected to provide access to
additional markets in Europe, South America, Asia and the Pacific Rim.
Corgenix's agreements with its international distribution partners are on terms
that are generally terminable by Corgenix if the distributor fails to achieve
certain sales targets. The Company also has established private labeled product
agreements with several United States and European companies. The Company has
international distribution headquarters in the United Kingdom and will add
direct commercialization and distribution in selected additional countries as
appropriate.
The Company has an active marketing and promotion program for its
diagnostic testing products. Corgenix publishes technical and marketing
promotional materials, which it distributes to current and potential customers.
The Company attends major industry trade shows and conferences, and the
Company's scientific staff actively publishes articles and technical abstracts
in peer review journals.
With the planned expansion into a Rapid Test product line, Corgenix expects
to expand its distribution network to sell into the outpatient primary care
market.
MANUFACTURING
Corgenix's manufacturing process for its products utilizes a semi-automated
production line for the manufacturing, assembly and packaging of its ELISA
Microplate products. Corgenix's current production capacity is 10,000 tests per
day with a single eight-hour shift. Since 1990, Corgenix's manufacturing group
has successfully produced over 10 million tests in its Westminster, Colorado
facility, and the Company expects that current manufacturing facilities will be
sufficient to meet expected customer demand for the foreseeable future.
The Company's manufacturing operations are fully integrated and consist of
reagent purification, reagent and Microplate processing, filling, labeling,
packaging and distribution. The Company has considerable experience in
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manufacturing its products using its proprietary technology. The Company
expects increases in the demand for its products, and plans to increase its
manufacturing capability while remaining in compliance with regulatory
requirements at acceptable costs to meet that increased demand. The Company
also maintains ongoing investigation of scale-up opportunities for
manufacturing to meet future requirements. Corgenix expects production costs
to decline if more products are added to the product menu in the future,
permitting the Company to achieve greater economies of scale as higher
volumes are attained. Corgenix has registered its facility with the FDA and
operates in compliance with the FDA Quality System Regulations ("QSR")
requirements for its products.
The manufacturing process starts with the qualification of raw materials.
The Microplates are then coated and bulk solutions prepared. The components and
the Microplates are checked for performance by the Company's quality control
department and adjustments in the bulk solutions are performed to provide
optimal performance and lot-to-lot consistency. The bulk solutions are then
dispensed and packaged into planned kit configurations. The final packaging step
in the manufacturing process includes kit assembly, where all materials are
packaged into finished product. The final kit has one final kit performance
performed by the Company's quality control department. The final stage before
product release for sale is quality assurance, verification that all quality
control testing and manufacturing processes have been completed, documented and
have met all performance specifications.
The majority of raw materials and purchased components used to
manufacture the Company's products are readily available. The Company has
established good working relationships with its primary vendors, particularly
those that supply unique or critical components for the Company's products.
Corgenix mitigates the risk of a loss of supply by maintaining a sufficient
supply of antibodies and critical components to ensure an uninterrupted
supply for at least three months. Corgenix also believes that it can
substitute a new supplier with regard to any of these components in a timely
manner. However, there can be no assurances that Corgenix will be able to
substitute a new supplier in a timely manner, and failure to do so could have
a material adverse effect on Corgenix's business, financial condition and
results of operations.
Corgenix purchases components for six products (anti-Sm, anti-SM/RNP,
anti-SSA, anti-SSB, anti-Jo-1, and anti-Scl-70) from Cambridge and performs
final assembly and shipping at the Company's United Kingdom facility. These
products are warehoused at this facility until shipped directly to customers.
The Company purchases four additional products from other manufacturers. The
von Willebrand Factor Activity Test is manufactured by American Biochemical &
Pharmaceutical Corporation ("ABP"), the Platelet Factor 4 test is
manufactured by GTI, Inc. ("GTI"), and the Thrombus Precursor Protein and
Functional Intact Fibrinogen tests are manufactured by American Biogenic
Science ("ABS").
A significant percentage of the Company's product revenues are derived from
sales outside of the United States. International regulatory bodies often
establish varying regulations governing product standards, packaging and
labeling requirements, import restrictions, tariff regulations, duties and tax
requirements. As a result of the Company's sales in Europe, the Company intends
to obtain ISO certification and to receive a "CE" mark certification, an
international symbol of quality and compliance with applicable European medical
device directives for certain of its products. The Company is currently
preparing for ISO certification and also expects to receive CE mark
certification.
CHUGAI STRATEGIC RELATIONSHIP
Chugai Diagnostics Science, Co. Ltd. is a wholly owned subsidiary of Chugai
Pharmaceutical Co., Ltd., a Tokyo based pharmaceutical company. The
relationship between Corgenix and Chugai was established in June 1993 with the
execution of a letter of intent to negotiate and execute a series of agreements
including a Manufacturing Memorandum, Stock Purchase Agreement and a
Distribution Agreement. The relationship is a multifaceted strategic
affiliation that can be summarized as follows:
EQUITY OWNERSHIP. In 1993, Chugai Pharma purchased common stock of REAADS
and currently owns approximately 4.6% of the Common Stock. Under the terms of
the September 1, 1993 stock purchase agreement, Chugai has certain rights,
including antidilution rights and rights to a board seat on the Corgenix Board
of Directors.
DISTRIBUTION OF CORGENIX PRODUCTS. In 1993, Corgenix and Chugai executed a
distribution agreement (the
<PAGE>
"Japanese Distribution Agreement") whereby Corgenix granted to Chugai certain
distribution rights in Japan of Corgenix products. The distribution rights
provide Chugai with non-exclusive rights for certain existing Corgenix
products, and exclusive rights for all future Corgenix products. The initial
term of the Japanese Distribution Agreement is for 7 years, expiring August
26, 2000, with successive one year extension options.
JOINT DEVELOPMENT OF CORGENIX PRODUCTS. In 1993, Corgenix and Chugai
executed a memorandum, which established a joint product development program
whereby Corgenix, in collaboration with Chugai, developed a unique second
generation immunodiagnostic assay for the measurement of HA. The product
replaced a first generation HA product that was being manufactured and
distributed in Japan by Chugai. This product is used to measure HA in serum to
aid in the diagnosis of certain liver diseases and the monitoring of rheumatoid
arthritis patients. In 1997, Corgenix and Chugai executed a contract research
agreement whereby Corgenix and Chugai made certain technical improvements to the
HA product, and Chugai provided certain financial support.
MANUFACTURING OF CORGENIX PRODUCTS. In 1994, Corgenix and Chugai executed a
manufacturing agreement (the "HA Manufacturing Agreement") whereby Corgenix has
the exclusive right to manufacture the HA product for Chugai for sale in Japan.
Corgenix began the manufacture of the HA product in 1995 and sales of the
product were initiated in Japan by Chugai. The HA Manufacturing Agreement has
been amended several times, and Corgenix now manufactures the HA product for
other distribution outlets to be designated by Chugai. In 1997, sales of the HA
product began in the United Kingdom through Corgenix's sales and distribution
channels. In 1995, Corgenix and Chugai executed a letter agreement whereby
Chugai agreed, under certain conditions, to reimburse Corgenix for the purchase
of certain pieces of equipment required for HA manufacturing.
REGULATORY AFFAIRS. In 1995, Corgenix and Chugai executed a regulatory
letter of understanding whereby Corgenix agreed to manage the regulatory
application prosecution of the HA kit in the United States for Chugai. Corgenix
managed the clinical trial testing of the HA product, and has filed a 510(k)
application on the HA product with the FDA on behalf of Chugai. See "--
Regulation."
HA PRODUCT DISTRIBUTION. In 1997, Corgenix and Chugai executed a
distribution agreement (the "UK Agreement") whereby Corgenix was granted
exclusive distribution rights for the Chugai HA product in the United Kingdom.
The UK Agreement is initially for a two-year period expiring on November 17,
1999, with one-year extension rights. The UK Agreement establishes certain
minimum sales target requirements for Corgenix, and provides early cancellation
rights to Chugai if Corgenix does not meet annual sales targets. The UK
Agreement is the only international distribution rights granted by Chugai.
OTHER STRATEGIC RELATIONSHIPS
In addition to the Chugai strategic relationship, an integral part of
Corgenix's strategy has been and will continue to be entering into other
strategic alliances as a means of accessing unique technologies or resources or
developing specific markets. The primary aspects of Corgenix's corporate
partnering strategy with Chugai and other strategic affiliations include:
- Companies that are interested in co-developing diagnostic tests that
use the Corgenix technology;
- Companies with complementary technologies;
- Companies with complementary products and novel disease markers;
and/or
- Companies with access to distribution channels that supplement
Corgenix's existing distribution channels.
In furtherance of the foregoing strategies, Corgenix has established
strategic relationships with the following companies in addition to Chugai:
CAMBRIDGE LIFE SCIENCES. Cambridge, a division of Byk Gulden and located in
Cambridge, United Kingdom,
<PAGE>
is a leading manufacturer of immunology and microbiology diagnostic tests. In
1993, Corgenix and Cambridge entered into an agreement by which the Company
provides to Cambridge certain products that are sold worldwide under the
Cambridge label. These products are primarily sold in the United Kingdom, and
in the remainder of Europe through the Byk Gulden distribution network.
Cambridge also manufactures certain products for Corgenix under the Corgenix
label including the anti-Sm, anti-SM/RNP, anti-SSA, anti-SSB, anti-Jo-1, and
anti-Scl-70, all of which are distributed by Corgenix worldwide.
HELENA LABORATORIES CORPORATION. Helena, a privately held company located
in Beaumont, Texas, is one of the world market leaders in clinical
electrophoresis instrumentation and technology. In 1993, Corgenix and Helena
entered into a development and manufacturing agreement pursuant to which
Corgenix developed a series of vascular disease products for joint distribution.
Three of these received FDA clearance in 1997 and one is currently in
development. Corgenix manufactures these products for worldwide distribution
through the Helena network, as well as under the Corgenix label for distribution
through the Corgenix network. Pursuant to the agreement, Helena has the right to
incorporate several of the Company's current products and technology (both those
jointly developed and also other Corgenix products) into a proprietary Helena
instrumentation for sale to hospitals and clinical laboratories. Corgenix and
Helena have also entered into an agreement under which the Company has agreed to
provide additional products to be sold worldwide under the Helena label. There
can be no assurance that the product development program will be successful, and
if successful, that the products developed will achieve broad market acceptance.
AMERICAN BIOCHEMICAL & PHARMACEUTICAL CORPORATION. ABP is a privately
held company located in Marlton, New Jersey that sells a line of diagnostic
products in coagulation and vascular medicine. In June 1998, Corgenix became a
non-exclusive distributor of ABP's von Willebrand Factor Activity in the United
States. Corgenix distributes this product under the Corgenix label through
Corgenix's distribution network, primarily in the United States. This product
complements Corgenix's expanding line of vascular disease products. The initial
term of the distribution arrangement with ABP will expire in June 2001 and it
may be renewed at Corgenix's election for additional successive one-year terms.
ABP also sells this test under the Corgenix label through its own distribution
network. Under the terms of a separate distribution agreement, ABP will sell the
Corgenix von Willebrand Factor Antigen Kit worldwide under the Corgenix label
through its distribution network.
AMERICAN BIOGENETIC SCIENCE ("ABS"). ABS is a publicly traded company
located in Boston, Massachusetts that has developed patented antigen-free
technology. In June 1998, Corgenix became a non-exclusive distributor of ABS's
Thrombus Precursor Protein and Functional Intact Fibrinogen products in the
United States and North America, marketing them through the Corgenix
distribution network. The initial term of the distribution agreement with ABS
will expire in August 1999 and it may be renewed at Corgenix's election for two
additional successive one-year terms. ABS also sells these tests under their own
labeling through a small network of regional distributors.
GTI, INC. GTI is a privately held company located in Brookfield, Wisconsin
that manufactures ELISA diagnostic products. In April 1998, Corgenix and GTI
signed an agreement by which Corgenix became a co-exclusive distributor of GTI's
Platelet Factor 4 ELISA test kit in the United States. The initial term of the
agreement is one year and may be renewed at Corgenix's option. This product is
also part of Corgenix's vascular disease product strategy.
The Company has established OEMs agreements with several international
diagnostic companies. Under these agreements, Corgenix manufactures selected
products under the partner's label for worldwide distribution. These
partnerships include Meditech-BioPool ( United States), Chromogenix (Sweden),
Medic (Italy), and Schiapparelli Biosystems (The Netherlands).
RESEARCH AND DEVELOPMENT
Corgenix is directing its research and development efforts towards
continuously improving its proprietary platform ELISA technology in the
Microplate format, as well as applying the technology to a Rapid Test format to
address operator ease-of-use and expand the Company's market opportunities. In
that regard, Corgenix has organized its research and development department into
three major areas: (i) new product development, (ii) technology assessment, and
(iii) technical and product support.
<PAGE>
The product development group is responsible for research and development
of new clinical diagnostic products for commercialization. This group evaluates
the performance of reagents (prepared internally or purchased commercially),
creates working prototypes of potential products, performs internal studies,
participates in clinical trials, produces pilot lots of new products, produces a
validated method that can be consistently manufactured, creates documentation
required for manufacturing and testing of new products, and works closely with
the Company's quality assurance department to satisfy regulatory requirements
and support regulatory clearance. This group includes individuals skilled in
immunology, assay development, protein biochemistry, biochemistry and basic
sciences. Group leaders are also skilled in planning and project management
under FDA-mandated design control. See "-- Regulation."
The technology assessment group is responsible for assessing the
performance of new technologies and determining the technical feasibility of
their introduction by Corgenix. The technology assessment group investigates
the patent / license issues associated with new technologies. This group
includes individuals skilled in immunology, assay development, protein
biochemistry, biochemistry, basic sciences and intellectual property review.
The technical and product support group are responsible for supporting all
products on the market through scientific investigation, and are responsible for
design transfer to manufacturing for all new products developed. This group
also assesses the performance of and validates all externally-sourced products.
This group includes individuals skilled in immunology, assay development,
protein biochemistry, biochemistry and basic sciences. Corgenix maintains
facilities to support its development efforts at its Westminster, Colorado
headquarters.
PRODUCTS AND TECHNOLOGY IN DEVELOPMENT
Corgenix intends to expand its product menu through internal development,
development in collaboration with strategic partners and acquisition or
licensing of new products and technologies. Corgenix is currently working with
partners to develop additional tests to supplement the existing product lines.
The following summarizes Corgenix's current product and technology development
programs:
ANTIPHOPHOLIPID ANTIBODY TESTING PRODUCTS
The Company has completed the development of three additional
antiphospholipid products to complement the existing line of five products in
the ELISA Microplate format. These new tests, anti- B2 Glycoprotein I - IgG,
anti- B2 Glycoprotein I - IgM and anti- 2 Glycoprotein I - IgA, will be marketed
for the diagnosis of antiphospholipid syndrome and related immunological
disorders. Corgenix is one of the market leaders in development of innovative
tests in the antiphospholipid market, and these future products will help ensure
the Company's strong position. These new antiphospholipid products have been
found to be more specific for thrombosis and the antiphospholipid syndrome over
the conventional aCL and aPS tests, and will be configured for sale to hospital
based and free-standing independent laboratories. Filing of the 510(k)
application on the new tests was made during the third quarter of 1998. See "--
Regulation."
VASCULAR DISEASE TESTS
The Company has entered into a joint development agreement to develop
additional assays for the measurement of selected coagulation factors that are
significant in the diagnosis and treatment of certain clotting and bleeding
disorders. The measurement of Free Protein S using a monoclonal antibody
provides a more direct and specific assay for the functionally active "free"
form of Protein S in the assessment of thrombosis. This project is currently at
the preclinical stage with FDA filing expected during the fourth quarter of
1998. These tests will use the Company's ELISA format and will provide
significant improvement over existing technology in the market. These assays
will also be formatted as Rapid Tests for the POC market. The Company is also
is early stage development of several unique immunological tests to measure risk
of coronary artery disease and stroke. These markers may prove to be far more
specific and functional than conventional cholesterol or lipid testing, and
could significantly change the risk assessment market worldwide.
Two of the products in early stage development are anti-oxidized LDL and
Lp(a). Atherosclerotic cardiovascular disease is the leading cause of death in
the industrialized world and in the United States alone there are
<PAGE>
over 1.5 million individuals suffering a heart attack every year. Application
of Corgenix technology to the measurement of anti-oxidized LDL antibodies and
Lp(a) will provide more clinically relevant tests compared with current
conventional tests for cholesterol.
RAPID TEST DELIVERY SYSTEM
Corgenix believes that the Rapid Test delivery technology will
significantly expand the POC market opportunity. This technology will allow the
introduction of next generation products, which will require a substantially
shorter period to develop, test and submit for regulatory approval. Each test
piece will contain all of the reagents necessary to conduct the assay, following
the simple step of sample addition. If successful, this technology could enable
the Company to make products that are easier to use and provide immediate
analysis of biological samples. Initial development will focus on qualitative
measurement of markers that aid in the establishment of the diagnosis or
prognosis of disease conditions. Products in early stage development include
tests for pregnancy, diagnosis of certain infectious diseases, and tests to
measure cardiac markers.
LIVER DISEASE MARKERS
The Company has a letter of intent with a medical university that, if
consummated, would grant Corgenix exclusive worldwide marketing rights to a
recently discovered, very sensitive liver enzyme. In early clinical testing,
this enzyme appears to be a unique indicator of the pending rejection of a
transplanted liver, and could also be a sensitive indicator of other causes of
cellular damage to liver tissue. Corgenix expects that development of a
diagnostic test for this enzyme, in multiple formats to address many market
segments, may begin in late 1998.
Corgenix's goal is to continue to develop and bring to the marketplace
innovative, unique diagnostic products with significant market potential,
resulting in more effective and less costly health care delivery. The Company
will take advantage of the many advances in biotechnology by developing new
products for the diagnosis and treatment of immunological disease. As discussed
above, future projects will include expansion into additional high growth areas
including infectious diseases.
ACQUISITIONS
On September 17, 1998, the Company executed a letter of intent to
acquire all of the assets of Integrated Diagnostics, Inc., a privately held,
Baltimore, Maryland diagnostics company, for cash and restricted Common Stock
valued at approximately $2.2 million. The closing of the transaction is
dependent upon the results of the Company's due diligence and upon the
negotiation and execution of a definitive agreement. There can be no
assurance that this transaction will be successfully consummated. See "Part
II. Item 6. Management's Discussion and Analysis of Financial Condition and
Results of Operations -- Forward Looking Statements and Risk Factors -- Risks
Regarding Potential Future Acquisitions."
The Company continually evaluates a variety of company, product and/or
technology acquisition opportunities. Although the Company intends to pursue
acquisitions that provide strategic opportunities to expand the Company's
core business while increasing revenues and earnings from these new
technologies, there can be no assurance that it will be successful in doing
so. See "Part II. Item 6. Management's Discussion and Analysis of Financial
Condition and Results of Operations -- Forward Looking Statements and Risk
Factors -- Risks Regarding Potential Future Acquisitions."
COMPETITION
Competition in the human medical diagnostics industry is significant. The
Company's competitors range from development stage diagnostics companies to
major domestic and international pharmaceutical companies. Many of these
companies have financial, technical, marketing, sales, manufacturing,
distribution and other resources significantly greater than Corgenix. In
addition, many of these companies have name recognition, established positions
in the market and long standing relationships with customers and distributors.
The diagnostics industry has recently experienced a period of consolidation
during which many of the large domestic and international pharmaceutical
companies have been acquiring mid-sized diagnostics companies, further
increasing the concentration of resources. However, competition in
<PAGE>
diagnostic medicine is highly fragmented, with no company holding a dominant
position in autoimmune, vascular diseases or bone and joint disease. There
can be no assurance that new, superior technologies will not be introduced
that could be directly competitive with or superior to Corgenix's
technologies.
Corgenix's competitors include Inova Diagnostics, Inc., Sanofi Diagnostics
Pasteur (a licensee of Corgenix technology under a paid up license), INCSTAR
Corporation, Pharmacia Upjohn, Diagnostica Stago, American Bioproducts, Helena
Laboratories Corporation (an existing licensee of Corgenix technology), Organon
Teknika, Helix Diagnostics, Hemagen Diagnostics, Sigma Diagnostics and Diamedix
Corporation. Some of these companies are larger than Corgenix and have
substantial resources and market presence. Corgenix competes against these
companies on the basis of product performance and customer service.
PATENTS, TRADE SECRETS AND TRADEMARKS
Corgenix has built a strong patent and intellectual property position
around its proprietary application of ELISA technology. Corgenix holds five
United States patents that expire beginning in 2004 and ending in 2010. Corgenix
has no pending patent applications. The Hyaluronic Acid product is protected by
U.S., Japanese and European patents held by Chugai. As part of the agreement
with Chugai, Corgenix has a license to use the Chugai patents to manufacture
this product.
Patent applications in the United States are maintained in secrecy until
patents issue. There can be no assurance that Corgenix's patents, and any
patents that may be issued to it in the future, will afford protection against
competitors with similar technology. In addition, no assurances can be given
that patents issued to Corgenix will not be infringed upon or designed around by
others or that others will not obtain patents that Corgenix would need to
license or design around. If the courts uphold existing or future patents
containing broad claims over technology used by Corgenix, the holders of such
patents could require Corgenix to obtain licenses to use such technology. See
"Part II. Item 6. Management's Discussion and Analysis -- Forward-Looking
Statements and Risk Factors -- Uncertainty of Protection of Patents, Trade
Secrets and Trademarks."
Corgenix has registered its trademark "REAADS" on the principal federal
trademark register and with the trademark registries in many countries of the
world. This trademark is eligible for renewal in 2006 and will expire in 2007.
The Company has a federal trademark registration pending for the name
"Corgenix."
The Company intends to obtain patent protection for its products and
processes, to preserve its trade secrets and to operate without infringing the
proprietary rights of third parties. Corgenix also relies on trade secrets and
proprietary know-how in its manufacturing processes. The Company requires each
of its employees, consultants and advisors to execute a confidentiality
agreement upon the commencement of any employment, consulting or advisory
relationship with the Company. Each agreement provides that all confidential
information developed or made known to the individual during the course of the
relationship will be kept confidential and not disclosed to third parties except
in specified circumstances. In the case of employees, the agreements provide
that all inventions conceived of by an employee shall be the exclusive property
of the Company.
REGULATION
The testing, manufacturing and sale of Corgenix's products are subject to
regulation by numerous governmental authorities, principally the FDA and foreign
regulatory agencies. The FDA regulates the clinical testing, manufacture,
labeling, distribution and promotion of medical devices, which includes
diagnostic products. Corgenix is restricted from marketing or selling diagnostic
products in the United States until clearance is received from the FDA. In
addition, various foreign countries in which Corgenix's products are or may be
sold impose local regulatory requirements. The preparation and filing of
documentation for FDA and foreign regulatory review can be a lengthy, expensive
and uncertain process.
In the United States, medical devices are classified by the FDA into one of
three classes (Class I, II or III) on the basis of the controls deemed necessary
by the FDA to ensure their safety and effectiveness in a reasonable manner.
Class I devices are subject to general controls (e.g., labeling, premarket
notification and adherence to QSR requirements).
<PAGE>
Class II devices are subject to general and special controls (e.g.,
performance standards, post-market surveillance, patient registries and FDA
guidelines). Generally, Class III devices are those that must receive
premarket approval by the FDA to ensure their safety and effectiveness (e.g.,
life-sustaining, life-supporting and implantable devices or new devices that
have been found not to be substantially equivalent to legally marketed
devices). All of Corgenix's current products and products under development
are or are expected to be classified as Class I or Class II devices.
Before a new device can be introduced in the market, the Company must
obtain FDA clearance or approval through either clearance of a 510(k) premarket
notification or approval of a product marketing approval ("PMA") application,
which is a more extensive and costly application. All of the Company's products
have been cleared using a 510(k) application, and the Company expects that most,
if not all, future products will also qualify for clearance using a 510(k)
application.
It generally takes from four to 12 months from submission to obtain 510(k)
premarket clearance but may take longer. The FDA may determine that a proposed
device is not substantially equivalent to a legally marketed device or that
additional information is needed before a substantial equivalence determination
can be made. A "not substantially equivalent" determination, or a request for
additional information, could prevent or delay the market introduction of new
products that fall into this category. For any devices that are cleared through
the 510(k) process, modifications or enhancements that could significantly
affect safety or effectiveness, or constitute a major change in the intended use
of the device, will require new 510(k) submissions. There can be no assurance
that Corgenix will be able to obtain necessary regulatory approvals or
clearances for its products on a timely basis, if at all, and delays in receipt
of or failure to receive such approvals or clearances, the loss of previously
received approvals or clearances, limitations on intended use imposed as a
condition of such approvals or clearances, or failure to comply with existing or
future regulatory requirements could have a material adverse effect on
Corgenix's business, financial condition and results of operations. See "Part
II. Item 6. Management's Discussion and Analysis -- Forward-Looking Statements
and Risk Factors -- Governmental Regulation of Diagnostic Products."
Corgenix's customers using diagnostic tests for clinical purposes in the
United States are also regulated under the Clinical Laboratory Information Act
of 1988 (the "CLIA"). The CLIA is intended to ensure the quality and reliability
of all medical testing in laboratories in the United States by requiring that
any health care facility in which testing is performed meets specified standards
in the areas of personnel qualification, administration, participation in
proficiency testing, patient test management, quality control, quality assurance
and inspections. The regulations have established three levels of regulatory
control based on test complexity: "waived," "moderately complex" and "highly
complex." Corgenix's current ELISA tests are categorized as "moderately
complex" tests for clinical use in the United States. Under the CLIA
regulations, all laboratories performing high or moderately complex tests are
required to obtain either a registration certificate or certification of
accreditation from the United States Health Care Financing Administration
("HCFA"). There can be no assurance that the CLIA regulations and future
administrative interpretations of CLIA will not have an adverse impact on the
potential market for Corgenix's future products. Corgenix expects that the to be
developed Rapid Tests will be categorized as CLIA "waived" tests. Laboratories
performing CLIA "waived" tests face less stringent registration and
certification requirements.
Corgenix also is subject to numerous federal, state and local laws relating
to such matters as safe working conditions, manufacturing practices,
environmental protection, fire hazard control and disposal of hazardous or
potentially hazardous substances. There can be no assurance that Corgenix will
not incur significant costs to comply with laws and regulations in the future or
that such laws or regulations will not have a material adverse effect upon
Corgenix's business, financial condition and results of operations.
REIMBURSEMENT
Corgenix's largest market segment is the hospital based and free standing
independent laboratory market. Payment for testing in this segment is largely
based on third party payor reimbursement. The site, which performs the test,
will submit an invoice to the patient's insurance provider (or the patient if
not covered by a program). Each diagnostic procedure (and in some instances,
specific technologies) is assigned a current procedural terminology ("CPT") code
by the American Medical Association. Each CPT code is then assigned a
reimbursement level by HCFA. Third party insurance payors typically establish a
specific fee to be paid for each code submitted. Third party payor
<PAGE>
reimbursement policies are generally determined with reference to the
reimbursement for CPT codes for Medicare patients, which themselves are
determined on a national basis by HCFA.
EMPLOYEES
As of June 18, 1998, Corgenix employed 32 employees, 27 full time and 5
part-time. Of these, 6 hold advanced scientific or medical degrees. None of
Corgenix's employees is covered by a collective bargaining agreement. Corgenix
believes that it maintains good relations with its employees.
ITEM 2. DESCRIPTION OF PROPERTY.
Corgenix currently leases approximately 12,000 square feet of space in one
building in Westminster, Colorado, which is used for its administrative offices,
research and development facilities and manufacturing operations. The lease
expires May 30, 2001 with renewal options. Corgenix also leases approximately
1,400 square feet of office space in Peterborough, Cambridgeshire, United
Kingdom under a lease that expires September 25, 2001. Corgenix believes that
suitable additional or alternative space will be available on commercially
reasonable terms as needed, but that its existing facilities will be sufficient
for its operational purposes through the end of the leases.
ITEM 3. LEGAL PROCEEDINGS
Corgenix is not a party to any material litigation or legal proceedings.
ITEM 4. SUBMISSION OR MATTERS TO A VOTE OF SECURITY HOLDERS.
In April 1998, an information statement (the "Gray Wolf Information
Statement") and a Statement of Majority Consent of Shareholders of Gray Wolf
(the "Statement of Consent") was mailed to all stockholders of record of Gray
Wolf. The purpose of the Statement of Consent was to obtain the former Gray
Wolf stockholders' authorization and to adopt resolutions pertaining to the
Merger. Of the 1,957,259 shares of Gray Wolf common stock outstanding,
consents were returned representing 1,167,125 shares. Of these shares,
1,167, 125 shares, or 59.6% of the total shares outstanding, voted for the
Merger, 0 shares voted against the Merger, and 790,134, or 40.4%, abstained
from voting.
On April 8, 1998, an information statement (the "REAADS Information
Statement") was mailed to all stockholders of record of REAADS. The REAADS
Information Statement provided information regarding the Merger and related to a
special meeting of the REAADS stockholders held on April 28, 1998. On April 23,
1998, a supplement to the REAADS Information Statement (the "First Supplement")
was mailed to stockholders of record providing additional information regarding
the Merger. On April 28, 1998, a special meeting of the stockholders of REAADS
was held to vote on the Merger. At the meeting, votes were recorded of two
classes of REAADS stockholders: (i) holders of shares of Preferred A Convertible
Redeemable Stock ("Series A Preferred Stock"), voting as a class, and (ii)
holders of shares of REAADS common stock voting as a class together with the
Series A Preferred Stock, as if converted to shares of common stock. Of the
113.2 shares of Series A Preferred Stock then outstanding, 113.2 shares voted
for the Merger, 0 shares voted against the Merger, and 0 shares abstained from
voting. Of the shares of REAADS common stock then outstanding and the Series A
Preferred Stock as converted to common stock, voting together as a class for
total of 175,535 shares, 139,700, or 79.6%, voted for the Merger, 0 shares voted
against the Merger, and 35,835 shares abstained from voting.
On May 7, 1998, a second supplement to the REAADS Information Statement
(the "Second Supplement"), together with a written consent, was mailed to
REAADS stockholders of record providing additional information regarding the
merger. Written consents were received and recorded for the holders of shares
of Series A Preferred Stock, voting as a class, and the holders of shares of
REAADS common stock voting as a class together with the Series A Preferred
Stock on an as-converted basis. Of the 113.2 shares of Series A Preferred
Stock then outstanding, 113.2 shares voted for the Merger, 0 shares voted
against the Merger, and 0 shares abstained from voting. Of the shares
<PAGE>
of REAADS common stock then outstanding and the Series A Preferred Stock as
converted to common stock, voting together as a class for total of 175,535
shares, 156,753, or 89.3%, voted for the Merger, 0 shares voted against the
Merger, and 18,782 shares abstained from voting.
GLOSSARY
ANTIBODY -- a protein produced by the body in response to contact with an
antigen, and having the specific capacity of neutralizing, hence creating
immunity to, the antigen.
ANTI-CARDIOLIPIN ANTIBODIES (aCL) -- a class of antiphospholipid antibody
which reacts with a negatively-charged phospholipid called cardiolipin;
frequently found in patients with SLE and other autoimmune diseases; also
reported to be significantly associated with the presence of both arterial and
venous thrombosis, thrombocytopenia, and recurrent fetal loss.
ANTIGEN -- an enzyme, toxin, or other substance, usually of high molecular
weight, to which the body reacts by producing antibodies.
ANTI-PHOSPHATIDYLSERINE ANTIBODIES (aPS) -- a class of antiphospholipid
antibody which reacts to phosphatidylserine; similar to aCL; believed to be
more specific for thrombosis.
ANTI-OXIDIZED LDL CHOLESTEROL ANTIBODIES -- antibodies to the oxidized
form of LDL cholesterol.
ANTIPHOSPHOLIPID ANTIBODIES -- a family of autoantibodies with specificity
against negatively charged phospholipids, that are frequently associated with
recurrent venous or arterial thrombosis, thrombocytopenia, or spontaneous fetal
abortion in individuals with SLE or other autoimmune disease.
ANTIPHOSPHOLIPID SYNDROME -- a clinical condition characterized by venous
or arterial thrombosis, thrombocytopenia, or spontaneous fetal abortion, in
association with elevated levels of antiphospholipid antibodies and/or lupus
anticoagulant.
ASSAY -- a laboratory test; to examine or subject to analysis.
AUTOANTIBODY -- an antibody with specific reactivity against a component
substance of the body in which it is produced; a disease marker.
AUTOIMMUNE DISEASES -- a group of diseases resulting from reaction of the
immune system against self components.
BETA 2 GLYCOPROTEIN I (B2GPI) -- a serum protein (cofactor) that
participates in the binding of antiphospholipid antibodies.
COAGULATION -- the process by which blood clots.
COFACTOR -- a serum protein that participates in the binding of
antiphospholipid antibodies, for example B2GPI.
DELIVERY FORMAT -- the configuration of the product. Current Corgenix
products utilize a 96-well microplate system for its delivery format.
HEMOSTASIS -- mechanisms in the body to maintain the normal liquid state of
blood; a balance between clotting and bleeding.
HYALURONIC ACID (HA) -- a polysaccharide found in synovial fluid, serum and
other body fluids and tissues,
<PAGE>
elevated in certain rheumatological and hepatic (liver) disorders.
HDL CHOLESTEROL -- high density lipoprotein associated with cholesterol.
IMMUNOASSAY -- a technique for analyzing and measuring the concentration of
disease markers using antibodies; for example, ELISA.
IMMUNOGLOBULIN -- a globulin protein that participates in the immune
reaction as the antibody for a specific antigen.
IMMUNOLOGY -- the branch of medicine dealing with (a) antigens and
antibodies, esp. immunity to disease, and (b) hypersensitive biological
reactions (such as allergies), the rejection of foreign tissues, etc.
IN VITRO -- isolated from the living organism and artificially maintained,
as in a test tube.
IN VIVO -- occurring within the living organism.
LDL CHOLESTEROL -- low density lipoprotein associated with cholesterol.
LIPIDS -- a group of organic compounds consisting of the fats and other
substances of similar properties.
LP(a) -- abnormal form of LDL cholesterol.
OXIDIZED LDL CHOLESTEROL -- chemical modification (oxidized form) of LDL
cholesterol; the most damaging form.
PLATELETS -- small cells in the blood which play an integral role in
coagulation (blood clotting).
PLATFORM TECHNOLOGY -- the basic technology in use for a majority of the
Company's products, in essence the "platform" for new products. In the case of
Corgenix, the platform technology is ELISA (enzyme linked immunosorbent assay).
PHOSPHOLIPIDS -- a group of fatty compounds found in animal and plant
cells which are complex triglyceride esters containing long chain fatty acids,
phosphoric acid and nitrogenous bases.
PROTEIN C -- normal blood protein that regulates hemostasis; decreased
levels lead to thrombosis.
PROTEIN S -- normal blood protein that regulates hemostasis; decreased
levels lead to thrombosis.
RHEUMATIC DISEASES -- a group of diseases of the connective tissue, of
uncertain cause and including rheumatoid arthritis (RA), rheumatic fever, etc.,
usually characterized by inflammation, pain and swelling of the joints and/or
muscles.
SERUM -- the clear yellowish fluid which separates from a blood clot after
coagulation and centrifugation.
SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) -- a usually chronic disease of unknown
cause, characterized by red, scaly patches that tend to produce scars,
frequently affecting connective tissue and involving the kidneys, spleen, etc.
THROMBIN -- the enzyme of the blood, formed from prothrombin, that causes
clotting by converting fibrinogen to fibrin.
THROMBOCYTOPENIA -- a condition in which there is an abnormally small
number of platelets in the circulating blood.
<PAGE>
THROMBOEMBOLISM -- the obstruction or occlusion of a blood vessel by a
thrombus.
THROMBOSIS -- coagulation of the blood within a blood vessel of any
organ, forming a blood clot.
TUMOR MARKERS --- serum proteins or molecules found in high concentrations
in patients with selected cancers.
VASCULAR -- of or pertaining to blood vessels.
VON WILLEBRAND'S FACTOR (vWF) -- normal blood protein that regulates
hemostasis; decreased levels lead to abnormal bleeding and increased levels may
produce thrombosis.
<PAGE>
PART II
ITEM 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS.
The Common Stock is currently traded on the OTC Bulletin Board -Registered
Trademark- under the symbol "COGX". From February 27, 1998 until the Merger on
May 22, 1998, the Common Stock was quoted on the OTC Bulletin Board -Registered
Trademark- under the symbol "GRWT." On September 22, 1998, the last bid price of
the Common Stock on the OTC Bulletin Board -Registered Trademark- as reported
by the OTC Bulletin Board -Registered Trademark- was $0.54.
The following table sets forth, for the periods indicated, the high and low
bid prices of the Common Stock as reported on the OTC Bulletin Board-Registered
Trademark-. The following quotations reflect inter-dealer prices, without
retail mark-up, mark-down or commissions, and may not represent actual
transactions.
<TABLE>
<CAPTION>
HIGH LOW
---- ---
<S> <C> <C>
YEAR ENDED JUNE 30, 1998
First Quarter. . . . . . . . . . . . . . . . . . . $-- $--
Second Quarter . . . . . . . . . . . . . . . . . . -- --
Third Quarter. . . . . . . . . . . . . . . . . . . -- --
Fourth Quarter . . . . . . . . . . . . . . . . . . $1.55 $0.31
Year Ended June 30, 1999
First Quarter (through September 22, 1998) . . . . $1.75 $0.28
</TABLE>
On September 17, 1998 there were approximately 52 holders of record of the
Common Stock.
To date, the Company has not paid any dividends on its Common Stock, and
the Board of Directors of the Company does not currently intend to declare cash
dividends on the Common Stock. The Company instead intends to retain its
earnings to support the growth of the Company's business. Any future cash
dividends would depend on future earnings, capital requirements and the
Company's financial condition and other factors deemed relevant by the Board of
Directors. The Company is restricted from paying dividends without the approval
of its financial advisor, pursuant to the terms of the Consulting Agreement with
TGF. See "Part III. Item 12. Certain Relationships and Related Transactions --
Consulting Agreement." In addition, under the terms of a promissory note in
favor of Eagle Bank, the Company is prohibited from paying dividends on the
Common Stock without the consent of Eagle Bank. The Series A Preferred Stock,
if and when issued, also would prohibit the Company from paying cash dividends
on the Company's Common Stock under certain circumstances.
MERGER TRANSACTION
In May 1998, the Company issued in a private transaction 6,120,000 shares
of Common Stock and 4,000,000 contingent shares of Common Stock in connection
with the merger of a wholly owned subsidiary of the Company with and into
REAADS. Such shares were issued to former securityholders of REAADS in exchange
for all of the outstanding securities of REAADS. Such shares were issued in
reliance upon exemptions from the registration requirements of Section 5 of the
Act provided by Rule 506 of Regulation D under the Act, complying with each of
the following requirements of Rule 506:
LIMITED NUMBER OF PURCHASERS. The Merger involved less than 35
purchasers.
NATURE OF PURCHASERS. Each of the shareholder purchasers was fully versed
in the business affairs and financial condition of REAADS, being either an
officer, director, long-time shareholder or long-time employee of REAADS. Each
such shareholder had received regular quarterly financial reports from
management regarding REAADS performance, and to management's knowledge and
belief based on reasonable inquiry, each was capable of evaluating the merits
and
<PAGE>
risks of the Merger based on his or her business and financial experience.
Because the Company had no significant business activity prior to the Merger,
an investment in the post-Merger Company was essentially an investment in
REAADS and its business. All shareholder purchasers were given the
opportunity to ask questions of management regarding the terms of the Merger.
Seven REAADS shareholders received their shares of Common Stock as a
compensatory stock bonus in cancellation of outstanding vested and unvested
REAADS incentive stock options, which otherwise were without market value (due
to their strike price being in excess of the estimated per share value of the
merger consideration). The REAADS Board of Directors and shareholders, by
unanimous vote, authorized the stock grants in cancellation of outstanding
options as consideration for past service and commitment to REAADS and as
incentive for each of the recipients to remain with the post-Merger Company,
each stock grant being coupled with a one-year vesting provision.
GENERAL CONDITIONS OF RULE 506 SATISFIED. Each of the general conditions
to the availability of Rule 506 was satisfied by the Merger. Request for
approval of the Merger was accompanied by a detailed information statement
describing the material terms and conditions of the Merger and containing the
information specified by Rule 502(b)(2)(i) of Regulation D to the extent
material to the an understanding of the issuer, its business and the securities
being offered. The Merger was not offered by any form of general solicitation
or general advertising. Finally, each of the shares issued in the Merger to
REAADS shareholders were made subject to strict limitations on resale, including
a mandatory one-year holding period, written disclosure to each recipient that
the shares to be received had not been registered under the Securities Act and
therefore could not be resold absent registration or availability of an
exemption from registration under the Act, and placement of a restrictive legend
setting forth the foregoing restrictions on transfer.
STATUTORY DISSENTER'S RIGHTS PROVIDED. In addition to complying with the
strict provisions of Rule 506, pursuant to state law statutory requirement, each
REAADS shareholder was provided with the opportunity to dissent from the Merger
and receive the fair value of his or her REAADS common stock. The information
statement included a detailed description of the statutory procedure for
exercising one's dissenter's rights. No REAADS shareholder exercised
dissenter's rights.
RULE 504 PRIVATE PLACEMENT
Also in May 1998, the Company sold in a private placement transaction a
total of 3,950,000 shares of Common Stock at a weighted average price of $.2532
per share to 28 investors, the majority of which were U.S. persons. These sales
were made in reliance upon exemptions from the registration requirements of
Section 5 of the Act provided by Rule 504 of Regulation D under the Act.
The issuance of the shares of Common Stock in the Offering met the
requirements of Rule 504 of Regulation D under the Act. At the time of the
Offering, the Company was not a reporting company under either the Act or the
Securities and Exchange Act of 1934, as amended. In addition, the Company is
not an "investment company" or "development company," as evidenced by the active
business and over five year operating results of the Company's wholly owned
operating subsidiary Corgenix, Inc. Finally, the amount of securities offered
and sold was within the regulatory maximum permitted by Rule 504.
ADDITIONAL PRIVATE PLACEMENTS
Also in May 1998, the Company issued 153,000 shares of Common Stock to TGF,
a financial advisor to the Company, in partial consideration of services
rendered to the Company. This sale was made in reliance upon an exemption from
the registration requirements of Section 5 of the Act provided by Rule 506 of
Regulation D under the Act. Based on information provided by TGF to the
Company, TGF is an "accredited investor" as defined at Rule 501(a)(8) of
Regulation D under the Act.
Between May 23, 1995 and May 22, 1998, REAADS granted options and warrants
to purchase its common stock to a total of four of its employees, which options
were exercisable at a price of $30.00 per share. During such period, one REAADS
employee exercised options previously granted to her and purchased two shares of
REAADS common stock for $15 per share. The option grants were made to employees
of REAADS in reliance upon exemptions
<PAGE>
from the registration requirements of Section 5 of the Act provided by Rule
701 under the Act.
As part of the Merger, all of REAADS options and warrants then outstanding
were exchanged for shares of REAADS common stock at a ratio of .3692 shares of
REAADS common stock per share of REAADS common stock underlying such option or
warrant.
ITEM 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION.
The following discussion should be read in conjunction with the financial
statements and accompanying notes included elsewhere in this Registration
Statement.
GENERAL
Since the Company's inception, Corgenix has been primarily involved in the
research, development, manufacturing and marketing of diagnostic tests for sale
to clinical laboratories. Corgenix currently markets 23 products covering
autoimmune disorders, vascular diseases, bone and joint diseases and liver
disease. Corgenix's products are sold in the United States through the Company's
marketing and sales organization that includes 14 sales representatives,
internationally through an extensive distributor network, and to several
significant OEM partners.
Corgenix manufactures products for inventory based upon expected sales
demand, shipping products to customers, usually within 24 hours of receipt of
orders. Accordingly, Corgenix does not operate with a backlog, and the Company
anticipates that its inventory will increase significantly in the future.
Except for the fiscal year ending June 30, 1997, the Company has
experienced revenue growth since its inception, primarily from sales of products
and contract revenues from strategic partners. Contract revenues consist of
licensing fees, milestone payments, and royalty payments from research and
development agreements with strategic partners.
Beginning in fiscal year 1996, Corgenix added third-party OEM licensed
products to its diagnostic product line, licensing six diagnostic products from
Cambridge. In 1998, the Company added four additional products to its product
line through OEM licenses from other third party manufacturers. Corgenix expects
to expand its relationships with other companies in the future to gain access to
additional products.
Although Corgenix has experienced growth in revenues every year since 1990
except for 1997, there can be no assurance that, in the future, Corgenix will
sustain revenue growth or achieve profitability. Corgenix's results of
operations may fluctuate significantly from period-to-period as the result of
several factors, including: (i) whether and when new products are successfully
developed and introduced, (ii) market acceptance of current or new products,
(iii) seasonal customer demand, (iv) whether and when Corgenix receives R&D
milestone payments and license fees from strategic partners, (v) changes in
reimbursement policies for the products that Corgenix sells;,(vi) competitive
pressures on average selling prices for the products that Corgenix sells, and
(vii) changes in the mix of products that Corgenix sells.
RESULTS OF OPERATIONS
YEARS ENDED JUNE 30, 1998 AND 1997
NET SALES. From its inception in 1990, the Company has achieved average
annual net sales growth of 30.9%. Net sales for the year ended June 30, 1998 was
$2.59 million, a 6.4% increase from $2.44 million in 1997. A component of net
sales, product sales, increased 13.7% to $2.58 million in 1998 from $2.27
million in 1997. Sales of Hyaluronic Acid product (HA) to Chugai for
distribution in Japan increased 14.3% from $671,000 in 1997 to $767,000 in 1998,
due to an increased marketing effort by Chugai following resolution of a
component design flaw in 1997.
<PAGE>
Also included in net sales are partnership payments from strategic
alliances that decreased from $200,000 in 1997 to $46,000 in 1998 due to timing
of ongoing development projects.
COST OF SALES. Cost of sales decreased 31.6% to $902,000 in 1998 from
$1,318,000 in 1997, due primarily to resolution of the design flaw in a critical
raw material component used in the HA product. In 1997, an additional $479,000
was charged to cost of sales because of this problem. The gross profit increased
from 45.9% in 1997 to 65.2% in 1998 due to this resolution. Excluding $479,000
in expense to correct the design flaw, gross profit would have been
approximately 65.5% in 1997.
RESEARCH AND DEVELOPMENT. Research and development expenses were flat,
increasing only 2.0% to $387,000 in 1998 from $380,000 in 1997. During 1998,
several ongoing projects remained in development but no new projects were added
during this period.
SELLING AND MARKETING. Selling and marketing expenses were also flat,
$751,000 in 1998 versus $742,000 in 1997.
GENERAL AND ADMINISTRATIVE. General and administrative expenses increased
41.3% to $1,023,000 in 1998 from $724,000 in 1997, due in part to legal,
accounting and other costs relating to strategic partnering activities,
financing activities and the costs of transforming into a public company.
OTHER EXPENSES. Other expenses increased 60.5% to $152,000 in 1998 from
$95,000 in 1997 due primarily to higher interest expense resulting from higher
debt levels throughout the year. Interest expense increased to $150,000 in 1998
from $50,000 in 1997, while factoring expenses decreased to $2,000 in 1998 from
$45,000 in 1997.
LIQUIDITY AND CAPITAL RESOURCES
Historically, the Company has financed its operations primarily through
sales of common and preferred stock, raising net proceeds of approximately $2.7
million from sales of these securities. In 1998, the Company raised $1,000,000
before offering expenses through a Reg. 504 offering related to the Merger
Transaction.
Corgenix has also received financing for operations from sales of
diagnostic products and agreements with strategic partners. At June 30, 1998 and
June 30, 1997, Corgenix had invested $215,084 and $349,427, respectively, (net
of accumulated depreciation) in leasehold improvements, laboratory and computer
equipment and office furnishings and equipment to support its development and
administrative activities.
Corgenix's principal sources of liquidity are short and long term debt
financing, of which $1,141,114 remained outstanding as of June 30, 1998.
Management believes that the Company needs to enter into new debt agreements
and/or sell additional equity securities in fiscal year 1999 to maintain
appropriate liquidity.
<PAGE>
RECENT ACCOUNTING PRONOUNCEMENTS
In June 1997, the Financial Accounting Standards Board (the "FASB") issued
Statement of Financial Accounting Standards, No. 130, REPORTING COMPREHENSIVE
INCOME ("Statement No. 130"), effective for years beginning after December 15,
1997. Statement No. 130 establishes standards for reporting and displaying
comprehensive income and its components in a full set of general-purpose
financial statements. The Company is not required and therefore has not yet
adopted Statement No. 130. The Company will comply with the reporting and
display requirements under this statement when required.
In June 1997, the FASB issued Statement of Financial Accounting Standards,
No. 131, DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION
("Statement No. 131"), effective for years beginning after December 15, 1997.
Statement No. 131 establishes standards for reporting information about
operating segments and the methods by which such segments were determined. The
Company is not required and therefore has not yet adopted Statement No. 131.
The Company will comply with the reporting requirements under this statement
when required.
In February 1998, the FASB issued Statement of Financial Accounting
Standards No. 132, EMPLOYERS' DISCLOSURES ABOUT PENSIONS AND OTHER
POSTRETIREMENT BENEFITS ("Statement No. 132"), effective for fiscal years
beginning after December 15, 1997. Statement No. 132 revises disclosures about
pension and other postretirement benefit plans. It does not change the
measurement or recognition of those plans. Statement No. 132 standardizes the
disclosure requirements and suggests combined formats for presentations of such
disclosures. The Company is not required and therefore has not yet adopted
Statement No. 132. The Company will comply with the reporting requirements
under this statement when required.
In April 1998, the American Institute of Certified Public Accountants
issued Statement of Position 98-5 (the "SOP") REPORTING ON THE COSTS OF START-UP
ACTIVITIES, effective for fiscal years beginning after December 15, 1998 and
encouraging earlier adoption. The SOP broadly defines start-up activities as
those one time activities related to, among other things, opening a new
facility. In general, the SOP requires the Company to expense as incurred those
costs. Currently, the Company expenses such costs.
In June 1998, FASB issued Statement of Financial Accounting Standards No.
133, Accounting for Derivative Instruments and Hedging Activities (Statement No.
133), effective for fiscal years beginning after June 15, 1999. Statement No.
133 establishes accounting and reporting standards for derivative instruments
and requires companies to recognize all derivatives as either assets or
liabilities in the statement of financial position and measure those instruments
at fair value. The Company has not yet adopted Statement No. 133. The Company
believes the accounting and reporting standards required by this statement will
not be significant. The Company will comply with the accounting and reporting
requirements under this statement when required.
YEAR 2000 EFFECT
The Year 2000 will impact computer programs written using two digits rather
than four to define the applicable year. Any programs with time-sensitive
software may recognize a date using "00" as the year 1900 rather than the year
2000. This could result in a system failure or miscalculations causing
disruptions of operation, including a temporary inability to process
transactions, send invoices or engage in other ordinary activities. This problem
largely affects software programs written years ago, before the issue came to
prominence. Corgenix recently reviewed all of its software
<PAGE>
for exposure to Year 2000 issues, including network and workstation software,
and does not believe that such software poses significant risks associated
with the Year 2000 problem. Corgenix primarily uses third-party software
programs written and updated by outside firms, each of whom has stated that
its software is Year 2000 compliant. To assure that all software programs can
successfully work in conjunction with each other using the Company's computer
hardware after the year 1999, Corgenix tested all of its software and
hardware during the third quarter of 1998 using a combination of past and
future dates. Such testing revealed that some of the Company's computer
hardware could not correctly process dates after December 31, 1999. The
Company will be required to replace such equipment, at a cost not expected to
exceed $20,000, before December 31, 1999.
The Company has set in motion an effort to obtain written assurances from
the Company's material suppliers regarding their Year 2000 compliance. As a
result of this effort, the Company expects to generate by the second quarter of
1999 a validated list of suppliers that are Year 2000 compliant, and will use
the entities on this list to obtain its supplies. If any of the Company's
single-source suppliers are not Year 2000 compliant by the third quarter of
1999, the Company plans to increase its inventories of the materials provided by
such suppliers and to carry a one-year supply of such materials.
The Company has also begun the process of obtaining written assurances from
the Company's material customers regarding their Year 2000 compliance. In
addition, the Company has instituted a requirement that all new customers
placing standing orders of the Company's products must certify in writing that
they are Year 2000 compliant or provide written assurances as to the steps they
are taking to become Year 2000 compliant. The Company's goal is to obtain by
the second quarter of 1999 written assurances from customers representing at
least 85% of its revenues that such customers are Year 2000 compliant or that
they are expecting to become Year 2000 compliant before December 31, 1999.
Although the Company has taken significant steps to address the Year 2000
problem, there can be no assurance that the failure of the Company and/or its
material customers or suppliers to timely attain Year 2000 compliance will not
materially reduce the Company's revenues or income, or that these failures
and/or the impacts of broader compliance failures by telephone, mail, data
transfer or other utility or general service providers or government or private
entities will not have a material adverse effect on the Company.
FORWARD-LOOKING STATEMENTS AND RISK FACTORS
This Registration Statement includes statements that are not purely
historical and are "forward-looking statements" within the meaning of Section
27A of the Securities Act of 1934, as amended, including statements regarding
the Company's expectations, beliefs, intentions or strategies regarding the
future. All statements other than historical fact contained in this
Registration Statement, including, without limitation, statements regarding
future product developments, acquisition strategies, strategic partnership
expectations, technological developments, the availability of necessary
components, research and development programs and distribution plans, are
forward-looking statements. All forward-looking statements included in this
Registration Statement are based on information available to the Company on
the date hereof, and the Company assumes no obligation to update such
forward-looking statements. Although the Company believes that the
assumptions and expectations reflected in such forward-looking statements are
reasonable, it can give no assurance that such expectations will prove to
have been correct or that the Company will take any actions that may
presently be planned.
Certain factors that could cause actual results to differ materially from
those expected include the following:
LOSSES INCURRED; FUTURE CAPITAL NEEDS; UNCERTAINTY OF ADDITIONAL FUNDING
The Company has incurred operating losses and negative cash flow from
operations for the last two fiscal years and the first nine months of the
current fiscal year. Losses incurred by the Company since its inception have
aggregated over $3 million, and there can be no assurance that the Company will
be able to generate positive cash flow to fund its operations in the near
future. Assuming no significant uses of cash in acquisition activities or other
significant changes, the Company believes it will have sufficient cash to
satisfy its funding needs for at least the next four months. If the Company is
not able to operate profitably and generate a positive cash flow, however, it
may need to raise additional
<PAGE>
capital to fund its continuing operations. If the Company needs additional
financing to meet its requirements, there can be no assurance that it will be
able to obtain such financing on terms satisfactory to it, if at all.
Alternatively, any additional equity financing may be dilutive to existing
stockholders, and debt financing, if available, may include restrictive
covenants. If adequate funds are not available, the Company might be
required to limit its research and development activities, which could have a
material adverse effect on the future of the Company's business.
DEPENDENCE ON COLLABORATIVE RELATIONSHIPS AND THIRD PARTIES FOR PRODUCT
DEVELOPMENT AND COMMERCIALIZATION
The Company has entered into licensing and research and development
agreements with collaborative partners, from which it derived a significant
percentage of its revenues in 1997. Pursuant to these agreements, the Company's
collaborative partners have specific responsibilities for the costs of
development, promotion, regulatory approval and/or sale of the Company's
products. The Company will continue to rely on present and future collaborative
partners for the development of products and technologies. There can be no
assurance that the Company will be able to negotiate future such collaborative
arrangements on acceptable terms, if at all, or that current or future
collaborative arrangements will be successful. To the extent that the Company
is not able to establish such arrangements, it could experience increased
capital requirements or be forced to undertake such activities at its own
expense. The amount and timing of resources that any of these partners devotes
to these activities will generally be based on progress by the Company in its
product development efforts. Usually, collaborative arrangements may be
terminated by the partner upon prior notice without cause and there can be no
assurance that any of these partners will perform its contractual obligations or
that it will not terminate its agreement. With respect to any products
manufactured by third parties, there can be no assurance that any third-party
manufacturer will perform acceptably or that failures by third parties will not
delay clinical trials or the submission of products for regulatory approval or
impair the Company's ability to deliver products on a timely basis. See "--
Dependance on Distribution Partners for Sales of Diagnostic Products in
International Markets," "Part I. Item 1. Description of Business -- Chugai
Strategic Relationship" and "-- Other Strategic Relationships."
NO ASSURANCE OF SUCCESSFUL OR TIMELY DEVELOPMENT OF ADDITIONAL PRODUCTS
The Company's business strategy includes the development of additional
diagnostic products. The Company's success in developing new products will
depend on its ability to achieve scientific and technological advances and to
translate these advances into commercially competitive products on a timely
basis. Development of new products requires significant research, development
and testing efforts. The Company will have limited resources to devote to the
development of products and, consequently, a delay in the development of one
product or the use of resources for product development efforts that prove
unsuccessful may delay or jeopardize the development of other products. Any
delay in the development, introduction and marketing of future products could
result in such products being marketed at a time when their cost and performance
characteristics would not enable them to compete effectively in their respective
markets. If the Company is unable, for technological or other reasons, to
complete the development and introduction of any new product or if any new
product is not approved or cleared for marketing or does not achieve a
significant level of market acceptance, the Company's results of operation could
be materially and adversely affected. See "Part I. Item 1. Description of
Business -- Products and Markets" and "--Regulation."
COMPETITION IN THE DIAGNOSTICS INDUSTRY
Competition in the human medical diagnostics industry is, and is expected
to remain, significant. The Company's competitors range from development stage
diagnostics companies to major domestic and international pharmaceutical
companies. Many of these companies have financial, technical, marketing, sales,
manufacturing, distribution and other resources significantly greater than those
of the Company. In addition, many of these companies have name recognition,
established positions in the market and long standing relationships with
customers and distributors. Moreover, the diagnostics industry has recently
experienced a period of consolidation, during which many of the large domestic
and international pharmaceutical companies have been acquiring mid-sized
diagnostics companies, further increasing the concentration of resources. There
can be no assurance that technologies will not be introduced that could be
directly competitive with or superior to the Company's technologies. See "Part
I. Item 1. Description of Business -- Competition."
<PAGE>
GOVERNMENTAL REGULATION OF DIAGNOSTICS PRODUCTS
The testing, manufacture and sale of the Company's products is subject to
regulation by numerous governmental authorities, principally the FDA and certain
foreign regulatory agencies. Pursuant to the Federal Food, Drug, and Cosmetic
Act, and the regulations promulgated thereunder, the FDA regulates the
preclinical and clinical testing, manufacture, labeling, distribution and
promotion of medical devices. The Company will not be able to commence
marketing or commercial sales in the United States of new products under
development until it receives clearance from the FDA. The testing for,
preparation of and subsequent FDA regulatory review of required filings can be a
lengthy, expensive and uncertain process. Noncompliance with applicable
requirements can result in, among other consequences, fines, injunctions, civil
penalties, recall or seizure of products, repair, replacement or refund of the
cost of products, total or partial suspension of production, failure of the
government to grant premarket clearance or premarket approval for devices,
withdrawal of marketing clearances or approvals, and criminal prosecution. See
"Part I. Item 1. Description of Business -- Regulation."
There can be no assurance that the Company will be able to obtain necessary
regulatory approvals or clearances for its products on a timely basis, if at
all, and delays in receipt of or failure to receive such approvals or
clearances, the loss of previously received approvals or clearances, limitations
on intended use imposed as a condition of such approvals or clearances or
failure to comply with existing or future regulatory requirements could have a
material adverse effect on the Company's business.
DEPENDENCE ON DISTRIBUTION PARTNERS FOR SALES OF DIAGNOSTIC PRODUCTS IN
INTERNATIONAL MARKETS
The Company has entered into distribution agreements with collaborative
partners in which Corgenix has granted distribution rights for certain Corgenix
products to these partners within specific international geographic areas.
Pursuant to these agreements, the Company's collaborative partners have certain
responsibilities for market development, promotion, and sales of the products.
If any of these partners fails to perform its contractual obligations or
terminates its agreement, this could have a material adverse effect on the
Company's business, financial condition and results of operation.
Additionally, the Company intends to expand its distribution network into
additional countries and into different market segments including the POC
market. There can be no assurance that Corgenix will be successful in the
expansion of the distribution network, and the failure to do so would have a
material adverse effect on the Company's business, financial condition and
results of operation.
GOVERNMENTAL REGULATION OF MANUFACTURING AND OTHER ACTIVITIES
As a manufacturer of medical devices for marketing in the United States,
the Company is required to adhere to applicable regulations setting forth
detailed good manufacturing practice requirements, which include testing,
control and documentation requirements. The Company must also comply with
Medical Device Report ("MDR") requirements, which require that a manufacturer
report to the FDA any incident in which its product may have caused or
contributed to a death or serious injury, or in which its product malfunctioned
and, if the malfunction were to recur, it would be likely to cause or contribute
to a death or serious injury. The Company is also subject to routine inspection
by the FDA for compliance with QSR requirements, MDR requirements and other
applicable regulations. The FDA has recently implemented new QSR requirements,
including the addition of design controls that will likely increase the cost of
compliance. Labeling and promotional activities are subject to scrutiny by the
FDA and, in certain circumstances, by the Federal Trade Commission. The Company
may incur significant costs to comply with laws and regulations in the future,
which may have a material adverse effect upon the Company's business, financial
condition and results of operations.
REGULATION RELATED TO FOREIGN MARKETS
Distribution of diagnostic products outside the United States is subject to
extensive government regulation. These regulations, including the requirements
for approvals or clearance to market, the time required for regulatory review
and the sanctions imposed for violations, vary from country to country. The
Company may be required to incur
<PAGE>
significant costs in obtaining or maintaining its foreign regulatory
approvals. In addition, the export by the Company of certain of its products
that have not yet been cleared for domestic commercial distribution may be
subject to FDA export restrictions. Failure to obtain necessary regulatory
or the failure to comply with regulatory requirements could have a material
adverse effect on the Company's business, financial condition and results of
operations.
UNCERTAIN AVAILABILITY OF THIRD PARTY REIMBURSEMENT FOR DIAGNOSTIC PRODUCTS
In the United States, health care providers that purchase diagnostic
products, such as hospitals and physicians, generally rely on third party
payors, principally private health insurance plans, federal Medicare and state
Medicaid, to reimburse all or part of the cost of the procedure. Third party
payors are increasingly scrutinizing and challenging the prices charged for
medical products and services and they can affect the pricing or the relative
attractiveness of the Decreases in reimbursement amounts for tests performed
using the Company's diagnostic products, failure by physicians and other users
to obtain reimbursement from third party payors, or changes in government and
private third party payors' policies regarding reimbursement of tests utilizing
diagnostic products, may affect the Company's ability to sell its diagnostic
products profitably. See "Part I. Item 1. Description of Business --
Regulation" and "-- Reimbursement." Market acceptance of the Company's products
in international markets is also dependent, in part, upon the availability of
reimbursement within prevailing health care payment systems.
UNCERTAINTY OF PROTECTION OF PATENTS, TRADE SECRETS AND TRADEMARKS
The Company's success depends, in part, on its ability to obtain patents
and license patent rights, to maintain trade secret protection and to operate
without infringing on the proprietary rights of others. There can be no
assurance that the Company's issued patents will afford meaningful protection
against a competitor, or that patents issued to the Company will not be
infringed upon or designed around by others, or that others will not obtain
patents that the Company would need to license or design around. The Company
could incur substantial costs in defending itself or its licensees in litigation
brought by others or prosecuting infringement claims against third parties. If
the outcome of any such litigation is unfavorable to the Company, the Company's
business could be adversely affected. See "Part I. Item 1. Description of
Business -- Patents, Trade Secrets and Trademarks."
RISKS REGARDING POTENTIAL FUTURE ACQUISITIONS
The Company's growth strategy includes as a material element the desire to
acquire complementary companies, products or technologies. Except as disclosed
in "Item 1. Description of Business -- Acquisitions," the Company has not
targeted any acquisition candidates and there is no assurance that the Company
will be able to identify appropriate companies or technologies to be acquired,
or to negotiate satisfactory terms for such an acquisition. Moreover, because
of limited cash resources, the Company will be unable to acquire any significant
companies or technologies for cash and the Company's ability to effect
acquisitions in exchange for the Company's capital stock may depend upon the
market prices for the Common Stock. If the Company does complete one or more
acquisitions, a number of risks arise, such as short-term negative effects on
the Company's reported operating results, diversion of management's attention,
unanticipated problems or legal liabilities, and difficulties in the integration
of potentially dissimilar operations. The occurrence of some or all of these
risks could have a material adverse effect on the Company's business, financial
condition and results of operations. See "Part I. Item 1. Description of
Business -- Strategy."
NO ASSURANCE OF MARKET ACCEPTANCE OF POINT-OF-CARE DIAGNOSTIC PRODUCTS
Another growth strategy of the Company is to seek to develop, manufacture
and market POC diagnostic products. Presently, the Company has no products used
in the POC market and there is no assurance that it will be successful in
developing and penetrating the POC market for diagnostic testing. Approximately
75% of diagnostic testing is currently performed at large clinical laboratories
rather than POC sites, and there can be no assurance that caregivers,
laboratories or the medical community in general will accept and utilize the POC
testing system in general or products that may be developed in particular.
Market acceptance of any POC products of the Company will depend on the
Company's ability to develop such products and then demonstrate the accuracy and
value of its products and to persuade caregivers to perform the Company's tests
in the caregivers' own facilities rather than send those tests to clinical
laboratories. In addition, market acceptance of new POC products will depend on
all of the factors that affect other new
<PAGE>
products. See "Part I. Item 1. Description of Business -- Industry
Overview," "-- Strategy" and "-- Products and Markets."
DEPENDENCE ON SUPPLIERS
The components of the Company's products include chemical and packaging
supplies that are generally available from several suppliers, except certain
antibodies, which the Company purchases from single suppliers. The Company
mitigates the risk of a loss of supply by maintaining a sufficient supply of
such antibodies to ensure an uninterrupted supply for at least six months.
Although the Company believes that it can substitute a new supplier with respect
to any of these components in a timely manner, there can be no assurances that
the Company will be able to substitute a new supplier in a timely manner and
failure to do so could have a material adverse effect on the Company's business,
financial condition and results of operations.
LIMITED MANUFACTURING EXPERIENCE WITH CERTAIN PRODUCTS
Although the Company has manufactured over ten million diagnostic tests
based on its proprietary applications of ELISA technology, certain of the
Company's diagnostic products in development, particularly POC tests,
incorporate technologies with which the Company has no manufacturing
experience. Assuming successful development and receipt of required
regulatory approvals, significant work may be required to scale up production
for each new product prior to such product's commercialization. There can be
no assurance that such work can be completed in a timely manner and that such
new products can be manufactured cost-effectively, to regulatory standards or
in sufficient volume.
SEASONALITY OF PRODUCTS; QUARTERLY FLUCTUATIONS IN RESULTS OF OPERATIONS
The Company's revenue and operating results have historically been
minimally subject to quarterly fluctuations. Certain of the Company's
diagnostic products in development, particularly POC tests for infectious
disease, may demonstrate a higher degree of seasonality. There can be no
assurance that such seasonality in the Company's results of operations will not
have a material adverse effect on the Company's business.
DEPENDENCE ON KEY PERSONNEL
Because of the specialized nature of the Company's business, the success of
the Company will be highly dependent upon its ability to attract and retain
qualified scientific and executive personnel. In particular, the Company
believes its success will depend to a significant extent on the efforts and
abilities of Dr. Luis R. Lopez and Douglass T. Simpson, who would be difficult
to replace. There can be no assurance that the Company will be successful in
attracting and retaining such skilled personnel, who are generally in high
demand by other companies. The loss of, inability to attract, or poor
performance by key scientific and executive personnel may have a material
adverse effect on the Company's business, financial condition and results of
operations.
PRODUCT LIABILITY EXPOSURE AND LIMITED INSURANCE
The testing, manufacturing and marketing of medical diagnostic devices
entails an inherent risk of product liability claims. To date, the Company has
experienced no product liability claims, but any such claims arising in the
future could have a material adverse effect on the Company's business, financial
condition and results of operations. The Company's product liability insurance
coverage is currently limited to $2 million. Potential product liability
claims may exceed the amount of the Company's insurance coverage or may be
excluded from coverage under the terms of the Company's policy or limited by
other claims under the Company's umbrella insurance policy. Additionally, there
can be no assurance that the Company's existing insurance can be renewed by the
Company at a cost and level of coverage comparable to that presently in effect,
if at all. In the event that the Company is held liable for a claim against
which it is not insured or for damages exceeding the limits of its insurance
coverage, such claim could have a material adverse effect on the Company's
business, financial condition and results of operations.
<PAGE>
LIMITED PUBLIC MARKET; POSSIBLE VOLATILITY IN STOCK PRICES; PENNY STOCK
RULES
There has, to date, been no active public market for the Company's Common
Stock, and there can be no assurance that an active public market will develop
or be sustained. Although the Company's Common Stock has been traded on the
OTC Bulletin Board-Registered Trademark- since February 1998, the trading has
been sporadic with insignificant volume.
Moreover, the over-the-counter markets for securities of very small
companies such as the Company historically have experienced extreme price and
volume fluctuations during certain periods. These broad market fluctuations and
other factors, such as new product developments and trends in the Company's
industry and the investment markets and economic conditions generally, as well
as quarterly variation in the Company's results of operations, may adversely
affect the market price of the Company's Common Stock. In addition, the
Company's Common Stock is subject to rules adopted by the Securities and
Exchange Commission regulating broker-dealer practices in connection with
transactions in "penny stocks." As a result, many brokers are unwilling to
engage in transactions in the Company's Common Stock because of the added
disclosure requirements.
ITEM 7. FINANCIAL STATEMENTS.
The financial statements listed in the accompanying index to the
consolidated financial statements are filed as part of this Annual Report on
Form 10-KSB.
ITEM 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE.
None.
PART III
ITEM 9. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS;
COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE ACT.
There is hereby incorporated by reference the information to appear under
the caption "Election of Directors" in the Company's proxy statement for its
1998 Annual Meeting of Shareholders, which will be filed with the Securities and
Exchange Commission within 120 days after June 30, 1998.
ITEM 10. EXECUTIVE COMPENSATION.
There is hereby incorporated by reference the information to appear under
the caption "Compensation of Directors and Executive Officers" in the Company's
proxy statement for its 1998 Annual Meeting of Shareholders, which will be filed
with the Securities and Exchange Commission within 120 days after June 30, 1998.
ITEM 11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT.
There is hereby incorporated by reference the information to appear under
the caption "Principal Shareholders of the Company" in the Company's proxy
statement for its 1998 Annual Meeting of Shareholders, which will be filed with
the Securities and Exchange Commission within 120 days of June 30, 1998.
ITEM 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS.
The Company has the following relationships with certain of its
stockholders, directors and affiliates.
<PAGE>
TGF CONSULTING AGREEMENT
The Company is party to a Consulting Agreement dated May 22, 1998 with
TGF. The Consulting Agreement was entered into in connection with closing of
the Merger. The president and controlling shareholder of TGF is Mike M.
Mustafoglu, who also serves as a director of the Company.
Under the terms of the Consulting Agreement, TGF provides advice to the
Company regarding financial and business matters, including but not limited
to, identifying sources of capital to implement the Company's business plans,
review and assessment of capitalization, merger and acquisition prospects,
and other transactions, on an exclusive basis. The Consulting Agreement is
effective for a three-year term ending May 22, 2001. TGF's fee for its
financial and business advisory services is $180,000.00 (payable in 36
monthly installments of $5,000) plus a transaction fee equal to (i) 5% of any
funds committed and available to the Company in an equity financing secured
through TGF and (ii) 3% of any funds committed and available to the Company
in any debt financing secured through TGF. In addition, in the event TGF
represents the Company with respect to a merger, acquisition or other
transaction involving the disposition or exchange of securities or assets of
the Company, TGF is entitled to a transaction fee equal to 5% of the total
market value of the stock, cash, assets or other property exchanged by the
Company or any of its security holders in connection with the transaction,
such fee payable in the same form as the consideration payable to the Company
or its security holders in the transaction. Finally, in the event TGF
introduces the Company to a joint venture partner or customer and sales
develop as a result of the introduction, TGF is entitled to a fee equal to 5%
of the before-tax income generated from the introduction, such fee payable
for the life of the venture or relationship developed.
In addition to the foregoing fees, TGF is entitled to reimbursement of its
fees and disbursements incurred in providing its advisory services to the
Company, including without limitation, travel, hotels, food and associated
expenses. The Consulting Agreement includes a number of covenants for the
benefit of TGF. The Company agrees to promptly furnish TGF a copy of all
periodic reports filed by the Company with the Securities and Exchange
Commission, a copy of all press releases released by the Company, copies of
financial statements and other periodic or special reports as and when provided
from time to time to holders of any class of the Company's securities or to its
directors and officers. The Company also agrees to provide such additional
documents and information with respect to the Company as TGF my from time to
time reasonably request.
The Consulting Agreement requires the Company to cause two designees
selected by TGF to be nominated to the Company's Board of Directors during each
year of the term of the Agreement, and to notify TGF of each meeting of the
Board. In connection with this right, the Company agrees that the Board of
Directors shall number five members, which number will not be changed without
the prior written consent of TGF, and that the Company will schedule not less
than four regular meetings of the Board of Directors. The right to designate
members to the Company's Board of Directors under the Consulting Agreement
terminates upon the issuance by the Company of an aggregate of 250,000 or more
shares of the Company's Series A Preferred Stock and warrants to purchase in
aggregate of 250,000 or more shares of the Company's Common Stock. Thereafter,
TGF is entitled to have an observer designated by it present at all meetings of
the Board of Directors. The Company agrees to indemnify and hold TGF and its
Board representatives harmless against any claims, damages, costs and expenses
arising solely out of attendance and participation at any Board meeting, and to
include such representatives on any liability insurance policy providing
coverage for the acts of the Company's officers and directors.
During the term of the Consulting Agreement, the Company is required to
obtain the written consent of TGF (not to be unreasonably withheld) prior to
issuing more than 5% of any class of its Common Stock or preferred stock (or
warrants, options or rights to purchase Common Stock or preferred stock).
The Consulting Agreement requires the Company to indemnify and hold TGF
harmless from any and all liabilities, claims, lawsuits or other judgments or
awards which it may become subject to ( a "Claim") insofar as such Claim arises
out of or is in connection with services rendered by TGF under the Consulting
Agreement or any transactions in connection therewith. Such indemnity excludes,
however, indemnification for Claims arising out of the reckless acts or
omissions of TGF. In turn, TGF agrees to indemnify and hold the Company
harmless against any and all Claims which arise out of or are based upon any
misstatement or omission made by the Company in reliance upon information
furnished in writing to the Company by TGF for inclusion in any registration
statement or prospectus in
<PAGE>
connection with a transaction to which the Consulting Agreement applies.
Pursuant to the Consulting Agreement, TGF has named Mike M. Mustafoglu
and Alev Lewis as its designees to be nominated as members of the Company's
Board of Directors. To date, TGF has provided general financial advisory
services to the Company pursuant to the Consulting Agreement. Such services
have included financial planning and review, business plan development,
identification of financing sources, identification of and due diligence on
acquisition opportunities, assistance in negotiating agreements, and
evaluation of strategic partner opportunities. TGF has informed the Company
that it does not engage in the business of buying and selling securities for
others or for its own account or advising others, for compensation, as to the
value of securities or the advisability of investing in, purchasing or
selling, securities. TGF has further informed the Company that it is not
currently licensed as a broker-dealer or investment advisor and that TGF is
not required to be so licensed to perform the activities called for under the
Consulting Agreement. TGF has agreed with the Company that if any such
activities are required to be performed by a licensed broker-dealer or
investment advisor, TGF will take the appropriate steps to obtain such
licenses or will inform the Company that it must retain a licensed
broker-dealer or investment company, as appropriate, to perform such
activities.
OPTION AGREEMENT
The Company also is party to an Option Agreement dated May 22, 1998 with
TGF. Under the Option Agreement, TGF has the option to purchase 1,000,000 units
(the "Units"), each unit comprised of one share of the Company's authorized but
unissued Series A 5% Convertible Preferred Stock and one warrant to purchase one
share of Common Stock at an exercise price of $2.00, for an aggregate purchase
price of $1,000,000. The option is exercisable by written notice to the Company
on or prior to the expiration of a period of 90 days after the date on which the
Securities and Exchange Commission declares effective a registration statement
covering the Units and the shares of Common Stock issuable upon conversion or
exercise thereof. The option is assignable, in whole or in part, by TGF;
however the option must be exercised collectively as to all of the Units subject
thereto. TGF may not, however, assign, sell, transfer, pledge or otherwise
dispose of any of the Units or any other securities of the Company without the
prior written consent of the Company.
CONTINGENT COMMON STOCK
Under the terms of the Merger Agreement, the former shareholders of REAADS
are entitled to receive up to an additional 4,000,000 shares of Common Stock
upon the occurrence (or non-occurrence) of certain events, as described below
(the "Contingent Shares").
The Contingent Shares are issuable from time to time on each of the
following events: (i) the conversion of one or more shares of the Company's
authorized but unissued Series A 5% Convertible Preferred Stock (the "Series A
Preferred Stock") to Common Stock or the exercise of one or more common stock
purchase warrants issued in connection with the Series A Preferred Stock
("Preferred Warrants") (the foregoing being referred to as a "Preferred Issue
Event"), in which case the maximum number of Contingent Shares issuable is
2,000,000 shares, (ii) November 23, 1998, if as of such date the Company has
sold less than $1,000,000 of Series A Preferred Stock (the "November 23, 1998
Issue Event"), in which case the maximum number of Contingent Shares issuable is
4,000,000 shares less (a) the number of shares of Common Stock issuable upon
conversion of all then outstanding Series A Preferred Stock and exercise of all
Preferred Warrants and less (b) four times the dollar amount of Series A
Preferred Stock sold by the Company as of such date.
The Contingent Shares are issuable to the former shareholders of REAADS
without payment of additional consideration. The former shareholders of REAADS
may not assign, sell, transfer, pledge or otherwise hypothecate or encumber
their right to receive Contingent Shares; they may, however, transfer their
right to receive Contingent Shares by will, gift and laws of descent and
intestacy.
The following table sets forth the number of shares of Common Stock that
would have been held by the persons indicated as of September 17, 1998, assuming
that all of the 4,000,000 shares of contingent Common Stock had been issued on
such date to the former REAADS stockholders.
<PAGE>
<TABLE>
<CAPTION>
SHARES BENEFICIALLY OWNED AFTER
CONTINGENT STOCK ISSUANCE
- -------------------------------------------------- --------------------------------
NAME OF BENEFICIAL OWNER NUMBER PERCENT
- -------------------------------------------------- --------------- -------------
<S> <C> <C>
Dr. Luis R. Lopez(1)(2). . . . . . . . . . . . . . 2,161,761 13.36%
Raul Diez Canseco(2) . . . . . . . . . . . . . . . 1,123,221 6.94%
Jana Hartinger Mazzini(2). . . . . . . . . . . . . 1,095,788 6.77%
Leland P. Snyder(2). . . . . . . . . . . . . . . . 1,043,997 6.45%
Brian E. Johnson(2). . . . . . . . . . . . . . . . 27,483 *
Mike M. Mustafoglu(2)(3) . . . . . . . . . . . . . 217,265 1.43%
Alev T. Lewis. . . . . . . . . . . . . . . . . . . 0 *
Douglass T. Simpson(2) . . . . . . . . . . . . . . 256,869 1.59%
Ann L. Steinbarger(2). . . . . . . . . . . . . . . 91,576 *
All directors and current executive officers
as a group (8 persons)(1)(2)(3). . . . . . . . 3,055,881 18.89%
</TABLE>
- ----------------
* Less than 1%
(1) Includes 153,000 shares held of record by Transition Partners Limited, as
to which Dr. Lopez has power to vote. Dr. Lopez disclaims beneficial
ownership of such shares.
(2) Except for 64,265 shares of Common Stock held by TGF (see Note 3), all of
such shares are restricted and cannot be transferred by the holder thereof
until May 23, 1999.
(3) Consists solely of shares held by TGF, of which Mr. Mustafoglu is the
president and controlling shareholder. Mr. Mustafoglu disclaims beneficial
ownership of such shares.
CORPORATE RELATIONS AGREEMENT
The Company is a party to an agreement dated April 14, 1998 with Corporate
Relations Group, a Florida corporation ("CRG"). Pursuant to this agreement and a
related payment agreement, CRG provides corporate relations services to the
Company for a period of one year for a fee of $75,000. In connection with the
execution of this Agreement, Gulf Atlantic Publishing, Inc. purchased 950,000
shares of the Company's Common Stock for total consideration of $50,000. CRG and
Gulf Atlantic Publishing, Inc. are both corporations that are wholly owned by
Strattcom Media, Ltd., a publicly-held corporation.
To date, CRG has provided the Company with investor relations services,
including assistance with the preparation and dissemination of press releases
and the preparation of articles regarding the Company and its products. CRG has
also assisted the Company in placing such articles in various magazines and
brochures published by certain of CRG's affiliates. CRG has informed the Company
that CRG is not a licensed broker-dealer or investment advisor, and that it is
not required to be so licensed to perform the activities called for under the
corporate relations agreement described above.
<PAGE>
ITEM 13. EXHIBITS AND REPORTS ON FORM 8-K.
A. INDEX TO AND DESCRIPTION OF EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER
- ------- DESCRIPTION OF EXHIBIT
----------------------
<S> <C>
2.1 Agreement and Plan of Merger dated as of May 12, 1998 by and among Gray
Wolf Technologies, Inc., Gray Wolf Acquisition Corp. And REAADS Medical
Products, Inc. (filed as Exhibit 2.1 to the Company's Registration
Statement on Form 10-SB filed June 29, 1998, and incorporated herein by
reference).
2.2 First Amendment to Agreement and Plan of Merger dated as of May 22, 1998
by and among Gray Wolf Technologies, Inc., Gray Wolf Acquisition Corp.
And REAADS Medical Products, Inc. (filed as Exhibit 2.2 to the Company's
Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
2.3 Second Amendment to Agreement and Plan of Merger dated as of June 17,
1998 by and among the Company and TransGlobal Financial Corporation.
(filed as Exhibit 2.3 to the Company's Registration Statement on Form
10-SB filed June 29, 1998, and incorporated herein by reference).
3.1 Articles of Incorporation, as amended (filed as Exhibit 3.1 to the
Company's Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
3.2 Bylaws (filed as Exhibit 3.2 to the Company's Registration Statement on
Form 10-SB filed June 29, 1998, and incorporated herein by reference).
4.1 Certificate of Designations for Series A Preferred Stock (filed as
Exhibit 4.1 to the Company's Registration Statement on Form 10-SB filed
June 29, 1998, and incorporated herein by reference).
10.1 Manufacturing Agreement dated September 1, 1994 between Chugai
Pharmaceutical Co., Ltd. and REAADS Medical Products, Inc. (filed as
Exhibit 10.1 to the Company's Registration Statement on Form 10-SB filed
June 29, 1998, and incorporated herein by reference).
10.2 Amendment to the Manufacturing Agreement dated as of January 17, 1995
between Chugai Pharmaceutical Co., Ltd. and REAADS Medical Products,
Inc. (filed as Exhibit 10.2 to the Company's Registration Statement on
Form 10-SB filed June 29, 1998, and incorporated herein by reference).
10.3 Amendment Agreement dated November 17, 1997 between Chugai Diagnostic
Science, Co., Ltd. and REAADS Medical Products, Inc. (filed as Exhibit
10.3 to the Company's Registration Statement on Form 10-SB filed June
29, 1998, and incorporated herein by reference).
10.4 Distribution Agreement dated August 26, 1993 between Chugai
Pharmaceutical Co., Ltd. and REAADS Medical Products, Inc. (filed as
Exhibit 10.4 to the Company's Registration Statement on Form 10-SB filed
June 29, 1998, and incorporated herein by reference).
10.5 Amendment to the Distribution Agreement dated September 7, 1994 between
Chugai Pharmaceutical Co., Ltd. and REAADS Medical Products, Inc. (filed
as Exhibit 10.5 to the Company's Registration Statement on Form 10-SB
filed June 29, 1998, and incorporated herein by reference).
10.6 Distribution Agreement dated November 14, 1997 between Chugai
Diagnostics Science Co, Ltd. and REAADS Bio-Medical Products (UK) Ltd.
(filed as Exhibit 10.6 to the Company's Registration Statement on Form
10-SB filed June 29, 1998, and incorporated herein by reference).
10.7 Product Development and Manufacturing Agreement dated September 12, 1994
between REAADS-Registered Trademark- Medical Products, Inc. and Helena
Laboratories Corporation (filed as Exhibit 10.7 to the Company's
Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
10.8 Amendment to Product Development and Manufacturing Agreement effective
December 15, 1997 between REAADS Medical Products, Inc. and Helena
Laboratories Corporation (filed as Exhibit 10.8 to the Company's
Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
10.9 Office Lease dated February 6, 1996 between Stream Associates, Inc. And
REAADS Medical Products, Inc.
</TABLE>
<PAGE>
<TABLE>
<S> <C>
(filed as Exhibit 10.9 to the Company's Registration Statement on Form
10-SB filed June 29, 1998, and incorporated herein by reference).
10.10 Guarantee dated November 1, 1997 between William George Flemming,
Douglass Simpson and Geoffrey Vernon Callen (filed as Exhibit 10.10 to
the Company's Registration Statement on Form 10-SB filed June 29, 1998,
and incorporated herein by reference).
10.11 Employment Agreement dated May 22, 1998 between Luis R. Lopez and the
Company (filed as Exhibit 10.11 to the Company's Registration Statement
on Form 10-SB filed June 29, 1998, and incorporated herein by
reference).
10.12 Employment Agreement dated May 22, 1998 between Douglass T. Simpson and
the Company (filed as Exhibit 10.12 to the Company's Registration
Statement on Form 10-SB filed June 29, 1998, and incorporated herein by
reference).
10.13 Employment Agreement dated May 22, 1998 between Ann L. Steinbarger and
the Company (filed as Exhibit 10.13 to the Company's Registration
Statement on Form 10-SB filed June 29, 1998, and incorporated herein by
reference).
10.14 Employment Agreement dated May 22, 1998 between Taryn G. Reynolds and
the Company (filed as Exhibit 10.14 to the Company's Registration
Statement on Form 10-SB filed June 29, 1998, and incorporated herein by
reference).
10.15 Employment Agreement dated May 22, 1998 between Catherine (O'Sullivan)
Fink and the Company (filed as Exhibit 10.15 to the Company's
Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
10.16 Consulting Contract dated May 22, 1998 between Wm. George Fleming, Bond
Bio-Tech, Ltd. and the Company (filed as Exhibit 10.16 to the Company's
Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
10.17 Stock Purchase Agreement dated September 1, 1993 between Chugai
Pharmaceutical Co., Ltd. and REAADS Medical Products, Inc. (filed as
Exhibit 10.17 to the Company's Registration Statement on Form 10-SB
filed June 29, 1998, and incorporated herein by reference).
10.18 Lead Generation/Corporate Relations Agreement dated April 14, 1998
between the Company and Corporate Relations Group, Inc. (filed as
Exhibit 10.18 to the Company's Registration Statement on Form 10-SB
filed June 29, 1998, and incorporated herein by reference).
10.19 Note dated January 6, 1997 between REAADS Medical Products, Inc. and
Eagle Bank (filed as Exhibit 10.19 to the Company's Registration
Statement on Form 10-SB filed June 29, 1998, and incorporated herein by
reference).
10.20 Deed of Guarantee Sterling and Currency dated May 14, 1997 by REAADS
Bio-Medical Products (UK) Limited (filed as Exhibit 10.20 to the
Company's Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
10.21 Option Agreement dated as of May 22, 1998 between TransGlobal Financial
Corporation and the Company (filed as Exhibit 10.21 to the Company's
Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
10.22 Consulting Agreement dated May 22, 1998 between TransGlobal Financial
Corporation and the Company (filed as Exhibit 10.22 to the Company's
Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
10.23 Distributor Agreement dated as of August 3, 1998 by and between American
Biogenetic Sciences, Inc. and the Company (filed as Exhibit 10.23 to
the Company's Registration Statement on Form 10-SB/A-1 filed September
24, 1998, and incorporated herein by reference).
10.24 Form of Indemnification Agreement between the Company and its directors
and officers (filed as Exhibit 10.24 to the Company's Registration
Statement on Form 10-SB/A-1 filed September 24, 1998, and incorporated
herein by reference).
21.1 Subsidiaries of the Registrant (filed as Exhibit 21.1 to the Company's
Registration Statement on Form 10-SB filed June 29, 1998, and
incorporated herein by reference).
</TABLE>
<PAGE>
<TABLE>
<S> <C>
23.1* Consent of Certified Public Accountants
27* Financial Data Schedule
</TABLE>
- ---------------------
*Filed herewith.
REPORTS ON FORM 8-K.
None.
<PAGE>
CORGENIX MEDICAL CORPORATION
INDEX TO FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
ITEM PAGE NUMBER
<S> <C>
Independent Auditors' Report F-1
Consolidated Balance Sheets as of June 30, 1998 and 1997 F-2
Consolidated Statement of Operations for Years Ended June 30,
1998 and 1997 F-3
Consolidated Statements of Stockholders' Equity (Deficit) for
the Years Ended June 30, 1998 and 1997 F-4
Consolidated Statements of Cash Flows for the Years Ended June
30, 1998 and 1997 F-5
Notes to Consolidated Financial Statements F-6
</TABLE>
<PAGE>
INDEPENDENT AUDITORS' REPORT
THE BOARD OF DIRECTORS
CORGENIX MEDICAL CORPORATION:
We have audited the accompanying consolidated balance sheets of Corgenix
Medical Corporation and subsidiary (Company) as of June 30, 1998 and 1997,
and the related consolidated statements of operations, stockholders' equity
(deficit) and cash flows for the years then ended. 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 financial statements are free
of material misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements.
An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above
present fairly, in all material respects, the financial position of Corgenix
Medical Corporation and subsidiary as of June 30, 1998 and 1997, and the
results of their operations and their cash flows for the years then ended, in
conformity with generally accepted accounting principles.
KPMG PEAT MARWICK LLP
Boulder, Colorado
August 28, 1998
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
JUNE 30, 1998 AND 1997
<TABLE>
<CAPTION>
1998 1997
----- -----
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 216,314 141,086
Accounts receivable, less allowance for doubtful accounts of
$6,600 and $3,400 in 1998 and 1997, respectively 369,710 601,939
Note receivable 27,425 -
Inventories 511,408 234,761
Prepaid expenses 16,876 12,492
---------- --------
Total current assets 1,141,733 990,278
---------- --------
Equipment:
Machinery and laboratory equipment 304,744 368,660
Furniture, fixtures and office equipment 238,761 224,521
---------- --------
543,505 593,181
Accumulated depreciation and amortization (328,421) (243,754)
---------- --------
Net equipment 215,084 349,427
---------- --------
Intangible assets:
Patents, net of accumulated amortization of $572,484 and $498,682
in 1998 and 1997, respectively 545,060 618,862
Goodwill, net of accumulated amortization of $45,528 and $28,969
in 1998 and 1997, respectively 2,356,946 32,619
---------- --------
2,902,006 651,481
---------- --------
Due from officer 12,000 12,000
Other assets 22,652 98,209
---------- --------
Total assets $4,293,475 2,101,395
---------- --------
---------- --------
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Current portion of notes payable $ 287,765 124,703
Accounts payable 427,809 529,546
Accrued payroll and related liabilities 106,757 109,038
Other liabilities 116,054 116,754
---------- --------
Total current liabilities 938,385 880,041
Notes payable, excluding current portion 853,349 915,641
---------- --------
Total liabilities 1,791,734 1,795,682
---------- --------
Mandatorily redeemable 12%, Class A Preferred stock, 2,000
shares authorized and 113.2 shares issued and outstanding in
1997, liquidation preference of $388,431 - 388,431
Stockholders' equity (deficit):
Preferred stock, $.001 par value. Authorized 5,000,000 shares,
none issued or outstanding - -
Common stock, $0.001 par value. Authorized 20,000,000 shares;
issued and outstanding 12,102,494 shares in 1998 12,102 -
Common stock, $0.01 par value. Authorized 500,000 shares;
issued and outstanding 164,000 shares in 1997 - 1,640
Additional paid-in capital 5,566,100 2,337,313
Stock subscription receivable (25,651) -
Accumulated deficit (3,050,810) (2,421,671)
---------- --------
Total stockholders' equity (deficit) 2,501,741 (82,718)
---------- --------
Commitments and contingencies (notes 5, 7, 9 and 11)
Total liabilities and stockholders' equity (deficit) $4,293,475 2,101,395
---------- --------
---------- --------
</TABLE>
See accompanying notes to consolidated financial statements.
F-2
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED JUNE 30, 1998 AND 1997
<TABLE>
<CAPTION>
1998 1997
---- ----
<S> <C> <C>
Net sales $ 2,592,175 2,435,965
Cost of sales 901,699 1,318,256
----------- ---------
Gross profit 1,690,476 1,117,709
Operating expenses:
Selling and marketing 751,244 742,200
Research and development 387,260 379,518
General and administrative 992,501 723,805
----------- ---------
2,131,005 1,845,523
----------- ---------
Operating loss (440,529) (727,814)
Other expenses:
Interest expense, net (150,148) (49,922)
Factoring expense (2,132) (44,977)
----------- ---------
(152,280) (94,899)
----------- ---------
Net loss $ (592,809) (822,713)
----------- ---------
----------- ---------
Net loss per share basic and diluted $ (.09) (.17)
----------- ---------
----------- ---------
Weighted average shares outstanding basic and diluted 6,343,133 4,920,000
</TABLE>
See accompanying notes to consolidated financial statements.
F-3
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
YEARS ENDED JUNE 30, 1998 AND 1997
- -------------------------------------------------------------------------------
<TABLE>
<CAPTION>
Common Common Total
stock, stock, Additional Stock stockholders'
$.01 $.001 paid-in subscription Accumulated equity
par par capital receivable deficit (deficit)
------ ------- -------- ---------- -------- ------------
<S> <C> <C> <C> <C> <C> <C>
BALANCES AT JUNE 30, 1996 $ 1,640 - 2,337,313 - (1,555,152) 783,801
Preferred stock dividend
requirement - - - - (43,806) (43,806)
Net loss - - - - (822,713) (822,713)
------- ------ --------- ------- ---------- ---------
BALANCES AT JUNE 30, 1997 1,640 - 2,337,313 - (2,421,671) (82,718)
Preferred stock dividend
requirement - - - - (36,330) (36,330)
Issuance of common stock 54 153 165,423 - - 165,630
Issuance of warrants to purchase
common stock - - 10,000 - - 10,000
Conversion of preferred stock
to common stock 56 - 169,744 - - 169,800
Conversion of options and
warrants to common stock 290 - 28,735 - - 29,025
Conversion of REAADS common
stock to Corgenix common
stock (2,040) 6,120 (4,080) - - -
Issuance of common stock in
connection with merger - 1,957 1,955,302 - - 1,957,259
Issuance of common stock in
private placement offering - 3,872 878,012 - - 881,884
Common stock subscription - - 25,651 (25,651) - -
Net loss - - - - (592,809) (592,809)
------- ------ --------- ------- ---------- ---------
BALANCES AT JUNE 30, 1998 $ - 12,102 5,566,100 (25,651) (3,050,810) 2,501,741
------- ------ --------- ------- ---------- ---------
------- ------ --------- ------- ---------- ---------
</TABLE>
See accompanying notes to consolidated financial statements.
F-4
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOW
JUNE 30, 1998 AND 1997
<TABLE>
<CAPTION>
1998 1997
---- ----
<S> <C> <C>
Cash flows from operating activities:
Net loss $ (592,809) (822,713)
Adjustments to reconcile net loss to net cash
used by operating activities:
Depreciation and amortization 175,028 132,576
Common stock issued for services 36,525 -
Accretion of interest 7,375 -
Provision (credit) for doubtful accounts 3,147 (28,216)
Changes in operating assets and liabilities, net of acquisition:
Accounts receivable 229,082 (104,302)
Inventories (276,647) 109,885
Prepaid expenses and other assets 71,173 (33,911)
Accounts payable (132,295) 226,437
Accrued payroll and related liabilities (2,281) 76,774
Other liabilities (700) (9,055)
----------- ---------
Net cash used by operating activities (482,402) (452,525)
----------- ---------
Cash flows from investing activities:
Purchases of equipment (14,240) (283,905)
Proceeds from return of equipment 63,916 -
Cash paid for acquisition costs (129,076) -
----------- ---------
Net cash used by investing activities (79,400) (283,905)
----------- ---------
Cash flows from financing activities:
Proceeds from issuance of common stock 881,914 -
Proceeds from issuance of notes payable 293,995 1,110,891
Payments on notes payable (483,561) (120,305)
Factor payables - (128,985)
Cash paid for financing costs (55,318) -
----------- ---------
Net cash provided by financing activities 637,030 861,601
----------- ---------
Net increase in cash and cash equivalents 75,228 125,171
Cash and cash equivalents at beginning of year 141,086 15,915
----------- ---------
Cash and cash equivalents at end of year $ 216,314 141,086
----------- ---------
----------- ---------
Supplemental disclosures:
Cash paid for interest $ 156,940 49,922
----------- ---------
----------- ---------
Acquisition:
Assets acquired $ 2,025,817 -
Liabilities assumed (68,558) -
Common stock issued (1,957,259) -
----------- ---------
Net cash paid for acquisition $ - -
----------- ---------
----------- ---------
Noncash financing activities:
Common stock warrants issued with note payable $ 10,000 -
----------- ---------
----------- ---------
Conversion of preferred stock to notes payable $ 254,961 -
----------- ---------
----------- ---------
Common stock subscription $ 25,651 -
----------- ---------
----------- ---------
</TABLE>
See accompanying notes to consolidated financial statements.
F-5
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 1998 AND 1997
- -------------------------------------------------------------------------------
(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BUSINESS, BASIS OF PRESENTATION AND MERGER
On May 22, 1998, REAADS Medical Products (REAADS) completed a merger with a
subsidiary of Gray Wolf Technologies, Inc., an inactive corporation with no
significant assets or operations. The resulting merged corporation was
named Corgenix, Inc. The parent corporation was renamed Corgenix Medical
Corporation (Corgenix or the Company). Effective with the merger, all
previously outstanding common stock, preferred stock, options and warrants
of REAADS were exchanged for common stock of Corgenix in an exchange ratio
of 1 share of REAADS in exchange for 30 shares of Corgenix, resulting in
the previous stockholders of REAADS owning approximately 76% of the common
stock of Corgenix.
Corgenix develops, manufactures and markets diagnostic products for the
serologic diagnosis of certain vascular diseases and autoimmune disorders
using proprietary technology. The Company markets its products to hospitals
and free-standing laboratories worldwide through a network of sales
representatives, distributors and private label (OEM) agreements. The
Company's offices and manufacturing facility are located in Westminster,
Colorado.
The consolidated financial statements include the accounts of the Company
and its wholly-owned subsidiary, REAADS Bio-medical Products (UK) Limited
(REAADS UK). REAADS UK was established as a United Kingdom company during
1996 to market the Company's products in Europe. The operations of REAADS
UK were not significant for the years ended June 30, 1998 and 1997.
USE OF 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 revenue and expenses
during the reporting period. Actual results could differ significantly from
those estimates.
CASH AND CASH EQUIVALENTS
The Company considers all highly liquid debt instruments, purchased with
maturities of three months or less to be cash equivalents.
F-6
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED
- -------------------------------------------------------------------------------
(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
INVENTORIES
Inventories are recorded at the lower of cost or market, using the
first-in, first-out method. Components of inventories as of June 30, are as
follows:
<TABLE>
<CAPTION>
1998 1997
---- ----
<S> <C> <C>
Raw materials $ 131,709 59,851
Work-in-process 210,307 138,080
Finished goods 169,392 36,830
--------- -------
$ 511,408 234,761
--------- -------
--------- -------
</TABLE>
EQUIPMENT
Equipment is recorded at cost. Depreciation, which totaled $84,667 and
$57,984 for the years ended June 30, 1998 and 1997, respectively, is
calculated primarily using the straight-line method over the estimated
useful lives of the assets which range from 3 to 7 years.
INTANGIBLE ASSETS
Intangible assets consist of purchased patents and goodwill, which are
amortized using the straight-line method over 15 years.
INCOME TAXES
Under the asset and liability method of recording income taxes, deferred
tax assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying
amounts of existing assets and liabilities and their respective tax bases.
Deferred tax assets and liabilities are measured using enacted tax rates
expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The effect on deferred
tax assets and liabilities of a change in tax rates is recognized in the
consolidated statements of operations in the period that includes the
enactment date.
REVENUE RECOGNITION
Revenue is recognized upon shipment of products.
RESEARCH AND DEVELOPMENT
Research and development costs and any costs associated with internally
developed patents, formulas or other proprietary technology are expensed as
incurred.
F-7
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED
- -------------------------------------------------------------------------------
LONG-LIVED ASSETS
The Company's long-lived assets are reviewed for impairment whenever events
or changes in circumstances indicate that the carrying amount of such
assets may not be recoverable. Events relating to recoverability may
include significant unfavorable changes in business conditions, recurring
losses, or a forecasted inability to achieve break-even operating results
over an extended period. The Company evaluates the recoverability of
long-lived assets based upon forecasted undiscounted cash flows. Should an
impairment in value be indicated, the carrying value of intangible assets
will be adjusted, based on estimates of future discounted cash flows
resulting from the use and ultimate disposition of the asset.
STOCK-BASED COMPENSATION
In accounting for its stock purchase and option plan, the Company records
compensation expense on the date of grant only if the current market price
of the underlying stock exceeds the exercise price. Pro forma net income
(loss) disclosures for employee stock option grants as if the fair value
based method had been applied are also provided.
(2) BUSINESS COMBINATION
On May 22, 1998, REAADS purchased, in an exchange of common stock, a
subsidiary of Gray Wolf Technologies, Inc. (Gray Wolf) in a transaction
accounted for using the purchase method of accounting. The total purchase
price and fair value of net assets acquired of Gray Wolf was $1,957,259.
Net assets acquired are as follows:
<TABLE>
<S> <C>
Net current assets $ 27,425
Intangible assets 1,998,392
Net current liabilities (68,558)
-----------
$ 1,957,259
-----------
-----------
</TABLE>
As Gray Wolf was an inactive corporation with no significant operations,
pro forma results of operations have not been presented, as there was no
impact on sales and a de minimis impact on the current period net loss. The
proforma results of operations for the year ended June 30, 1998, from the
amortization of goodwill from the acquisition would be $133,226. The
results of operations subsequent to the date of acquisition are included in
the Company's consolidated operations.
F-8
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED
- -------------------------------------------------------------------------------
(3) NOTES PAYABLE
Notes payable consist of the following at June 30, 1998 and 1997:
<TABLE>
<CAPTION>
1998 1997
---- ----
<S> <C> <C>
Note payable to Eagle Bank, with interest at prime plus 2.75% (11.25% at
June 30, 1998), due in monthly installments of $14,000 through
January 2007, collateralized by the Company's common stock,
commercial security agreements and a key
man life insurance policy $ 918,603 976,532
Note payable to Eagle Bank, with interest at the bank's base lending
rate plus 2% (11.25% at June 30, 1998) due in monthly installments
of $2,000 and a balloon payment due December 30, 1998,
collateralized by accounts receivable 40,000 50,000
Notes payable to former preferred stockholders, with interest at
12%, due November 8, 1998 144,511 -
Note payable, with interest at prime plus 3%
(11.50% at June 30, 1998), due on demand 38,000 -
Notes payable to officers of the Company with interest
rates ranging from 8% to 22%, repaid in 1998 - 13,812
---------- ---------
1,141,114 1,040,344
Less current portion (287,765) (124,703)
---------- ---------
Notes payable, excluding current portion $ 853,349 915,641
---------- ---------
---------- ---------
</TABLE>
Aggregate maturities of notes payable by year as of June 30, 1998, are
as follows:
<TABLE>
<CAPTION>
Years ending June 30:
<S> <C>
1999 $ 287,765
2000 72,986
2001 81,634
2002 91,303
2003 102,125
Thereafter 505,301
----------
$1,141,114
----------
----------
</TABLE>
The carrying values of notes payable approximate fair value based on their
terms and floating market based interest rates.
F-9
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED
- -------------------------------------------------------------------------------
(4) COST OF SALES
During the year ended June 30, 1997, the Company included a charge of
$479,000 in cost of sales due to a product design flaw of a raw material
component used in one of the Company's products. A sole source manufacturer
in Japan provided the raw material component. The Company was contractually
obligated to purchase the raw material from this manufacturer through a
contract with the Company's largest customer, Chugai Pharmaceutical Co.,
Ltd. The product design flaw has been resolved to the satisfaction of the
customer.
(5) STOCKHOLDERS' EQUITY
PREFERRED STOCK
The Company previously issued 113.2 shares of mandatorily redeemable
Class A voting preferred stock, which was recorded at liquidation value
which approximated fair market value at the date of issuance. Pursuant to
the purchase of Gray Wolf, one-half of the shares of preferred stock were
converted into common stock and one-half of the shares of preferred stock
plus all unpaid dividends were converted into notes payable.
COMMON STOCK
In connection with the merger, the Company may have an obligation to issue
4,000,000 shares of contingent common stock to former REAADS stockholders.
The contingent shares are issuable upon the occurrence of the following
events: (i) the conversion of one or more shares of the Company's
authorized but unissued Series A 5% convertible preferred stock to common
stock or the exercise of one or more common stock purchase warrants issued
in connection with the Series A Preferred Stock, in which case the maximum
number of contingent shares issuable is 2,000,000 shares, (ii) November 23,
1998, if as of such date the Company has sold less than $1,000,000 of
Series A Preferred Stock, in which case the maximum number of contingent
shares issuable is 4,000,000 shares less (a) the number of shares of common
stock issuable upon conversion of all then outstanding Series A preferred
stock and exercise of all preferred stock less (b) four times the dollar
amount of Series A preferred stock sold by the Company as of such date. The
contingent shares are issuable to the former stockholders of REAADS without
payment of additional consideration.
Effective with the purchase of Gray Wolf, 3,872,235 shares of Corgenix
common stock were issued at a weighted average price of $.2532 per share.
Proceeds of $881,884 were recorded net of commissions and expenses. An
additional 77,765 shares of Corgenix common stock were subscribed, and a
subscription receivable was recorded of $25,651.
(6) STOCK PURCHASE AND OPTION PLAN
Prior to the purchase of Gray Wolf, the Company had a stock purchase and
option plan, whereby, the Company sold shares of its stock, and/or granted
options to purchase shares of its common stock to key employees, officers,
directors and consultants, as determined by
F-10
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED
- -------------------------------------------------------------------------------
(6) STOCK PURCHASE AND OPTION PLAN (CONTINUED)
the Company's Board of Directors. Options under this plan were granted at
not less than exercisable over 5 to 10 year periods. All such options were
converted to shares of common stock pursuant to the merger agreement
entered into with the purchase of Gray Wolf with no monetary consideration
received by the Company. Accordingly, no options are outstanding at June
30, 1998.
As the Company granted options at fair value, no compensation cost has been
recognized for its stock options in the consolidated financial statements.
Had compensation cost for the Company's stock-based compensation plan been
determined as fair value at the grant dates for awards under the plan, the
Company's net loss would have been increased to the proforma amount
indicated below:
<TABLE>
<CAPTION>
June 30, 1997
--------------
<S> <C>
Net loss:
As reported $ 822,713
Proforma 840,637
</TABLE>
The fair value of each option grant was estimated on the date of grant
using the Black-Scholes option-pricing model with the following
weighted-average assumptions used for grants in the year ended June 30,
1997; no dividend yield, no volatility, risk-free interest rate of 5.6
percent, and expected life of 4 years.
A summary of the status of the Company's fixed stock options plan for the
year ended June 30, 1997, is presented below:
<TABLE>
<CAPTION>
Weighted average
Shares exercise price
------ -----------------
<S> <C> <C>
Outstanding at beginning of year 44,500 $ 22
Granted 4,300 30
Exercised - -
Forfeited (1,300) 30
------- --
Outstanding at June 30, 1997 47,500 23
------- --
------- --
Options exercisable at June 30, 1997 32,550
Weighted-average fair value of options granted during the year $ 30
</TABLE>
F-11
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED
- -------------------------------------------------------------------------------
(7) COMMITMENTS AND CONTINGENCIES
ROYALTY AGREEMENT
The Company has a royalty agreement with BioStar Medical Products, Inc.
(BioStar) whereby the Company pays 5% of certain product sales, up to an
aggregate of $600,000, in royalties. As of June 30, 1998, $538,962 of
cumulative royalties have been paid to BioStar. Royalty expense under this
agreement totaled $91,574 and $99,521 for the years ended June 30, 1998 and
1997, respectively.
LEASES
The Company is obligated under various noncancelable operating leases
primarily for its operating facility and certain office equipment. The
leases generally require the Company to pay related insurance costs,
maintenance costs and taxes. Future minimum lease payments under
noncancelable operating leases with initial or remaining terms in excess of
one year as of June 30, 1998 are as follows:
<TABLE>
<CAPTION>
Years ending June 30:
<S> <C>
1999 $135,000
2000 133,000
2001 135,000
2002 11,000
--------
Total future minimum lease payments $414,000
--------
--------
</TABLE>
Rent expense totaled $115,311 and $121,235 for the years ended June 30,
1998 and 1997, respectively.
EMPLOYMENT AGREEMENTS
The Company has employment agreements with certain key employees, certain
of whom are also stockholders. In addition to salary and benefit
provisions, these agreements include defined commitments should the
employees terminate their employment with or without cause.
(8) INCOME TAXES
At June 30, 1998, the Company has a net operating loss carryforward for
income tax purposes of approximately $2,738,000 expiring during the period
from 2006 to 2013. Research and development tax credit carryforwards
approximate $135,220. The future utilization of the operating loss
carryforwards or the time period in which the carryforwards could be
utilized could be limited if certain historical stockholders of REAADS sell
their shares within two years of the purchase of Gray Wolf.
F-12
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED
- -------------------------------------------------------------------------------
As of June 30, 1998, the Company had a gross deferred tax asset of
approximately $338,400 relating primarily to the Company's net operating
losses and research and development credit carryforwards. A valuation
allowance in the amount of the deferred tax asset has been recorded due to
management's determination that it's not more likely than not that the tax
assets will be utilized.
(9) RELATED PARTY TRANSACTIONS
The Company has a consulting agreement with TransGlobal Financial
Corporation (TGF), a company whose president also serves as a director of
Corgenix. TGF is to provide business and financial advice in return for a
monthly fee of $5,000 through May 22, 2001, plus a percentage of funds
committed and available to the Company through debt or equity financing.
TGF is also entitled to a transaction fee for any business combination or
joint venture it represents for Corgenix. Two of Corgenix's directors will
be nominated by TGF for the term of the agreement unless the Company issues
an aggregate of 250,000 or more shares of Series A preferred stock and
warrants to purchase an aggregate of 250,000 or more shares of common
stock. Thereafter, TGF is entitled to have a designated observer present at
all board meetings. During the term of the agreement, the Company is
required to obtain TGF's written consent prior to issuing more than 5% of
any class of common or preferred stock.
The Company has issued options to TGF for the purchase of 1,000,000 units
of Series A 5% convertible preferred stock and warrants to purchase one
share of common stock at an exercise price of $2.00, for an aggregate
purchase price of $1,000,000.
The Company has entered into product development, manufacturing and
distribution agreements with Chugai, which provide certain rights for
Chugai to distribute the Company's products in Japan.
In November 1997, the Company borrowed $100,000 under a note payable from a
stockholder. The note and related interest was repaid in May 1998.
Amounts due from an officer are due on June 6, 1999, and do not bear
interest.
(10) CONCENTRATION OF CREDIT RISK
The Company's customers are principally located in the United States,
although it has some foreign customers. The Company has a distribution
agreement with Cambridge Life Sciences plc to distribute the Company's
products in Europe. The Company performs periodic credit evaluations of its
customers' financial condition but generally does not require collateral
for receivables.
Chugai is the Company's largest customer, representing approximately 30%
and 40% of sales in the years ended June 30, 1998 and 1997, respectively,
and approximately 21% and 37% of accounts receivable at June 30, 1998 and
1997, respectively.
F-13
<PAGE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS, CONTINUED
- -------------------------------------------------------------------------------
(11) SUBSEQUENT EVENT
In July 1998, the Company received proceeds of $25,651 under its common
stock subscription and the related common shares were issued.
F-14
<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, on this 28th day of September, 1998.
CORGENIX MEDICAL CORPORATION
By: /s/
--------------------------------
Luis R. Lopez, M.D.
Chairman and Chief Executive Officer
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 and on
the dates indicated.
<TABLE>
<CAPTION>
SIGNATURES TITLE DATE
<S> <C> <C>
/s/
- --------------------
Luis R. Lopez, M.D. Chairman of the Board, Chief September 28, 1998
Executive Officer and Director
(principal executive officer)
/s/
- --------------------
Douglass T. Simpson President (principal financial and September 28, 1998
accounting officer) and Director
/s/
- --------------------
Brian E. Johnson Director September 28, 1998
/s/
- --------------------
Mike M. Mustafoglu Director September 28, 1998
/s/
- --------------------
Alev Lewis Director September 28, 1998
</TABLE>
<PAGE>
EXHIBIT 11.1
CORGENIX MEDICAL CORPORATION
STATEMENT REGARDING COMPUTATION OF NET INCOME PER SHARE
(IN THOUSANDS, EXCEPT PER SHARE DATA)
<TABLE>
<CAPTION>
YEAR ENDED JUNE 30,
-------------------
1998 1997
---- ----
<S> <C> <C>
Weighted average shares .................... 6,343 4,920
------ ------
Total shares used for per share calculations 6,343 4,920
Net loss ................................... (593) (823)
Net income per common share ................ $ (.09) $ (.17)
</TABLE>
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
COMPANY'S ANNUAL REPORT ON FORM 10-K AND IS QUALIFIED IN ITS ENTIRETY BY
REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 12-MOS
<FISCAL-YEAR-END> JUN-30-1998
<PERIOD-START> JUL-01-1997
<PERIOD-END> JUN-30-1998
<CASH> 216
<SECURITIES> 0
<RECEIVABLES> 376
<ALLOWANCES> 7
<INVENTORY> 511
<CURRENT-ASSETS> 1,142
<PP&E> 544
<DEPRECIATION> 328
<TOTAL-ASSETS> 4,293
<CURRENT-LIABILITIES> 938
<BONDS> 0
0
0
<COMMON> 12
<OTHER-SE> 5,540
<TOTAL-LIABILITY-AND-EQUITY> 4,293
<SALES> 2,546
<TOTAL-REVENUES> 2,592
<CGS> 902
<TOTAL-COSTS> 902
<OTHER-EXPENSES> 2,131
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 150
<INCOME-PRETAX> (593)
<INCOME-TAX> 0
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (593)
<EPS-PRIMARY> (.09)
<EPS-DILUTED> (.09)
</TABLE>
