SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-QSB
|X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES AND
EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 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 (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)
(Former name, former address and former fiscal year,
if changed since last report)
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|
The number of shares of Common Stock outstanding was 12,027,259 as of
September 30, 1998.
Transitional Small Business Disclosure Format. Yes |_| No |X|
<PAGE>
CORGENIX MEDICAL CORPORATION
SEPTEMBER 30, 1998
TABLE OF CONTENTS
Page
----
PART I
FINANCIAL INFORMATION
Item 1. Financial Statements.................................................3
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations..................................7
PART II
OTHER INFORMATION
Item 1. Legal Proceedings ..................................................14
Item 2. Changes in Securities and Use of Proceeds ..........................14
Item 3. Defaults Upon Senior Securities ....................................14
Item 4. Submission of Matters to a Vote of Security Holders ................14
Item 5. Other Information ..................................................14
Item 6. Exhibits and Reports on Form 8-K ...................................14
-2-
<PAGE>
<TABLE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
Consolidated Balance Sheets
- ---------------------------------------------------------------------------------
<CAPTION>
September 30, June 30,
Assets 1998 1998
-------------- -----------
(Unaudited)
<S> <C> <C>
Current Assets:
Cash and cash equivalents $ 56,628 216,314
Accounts receivable, less allowance
for doubtful accounts of $6,600 315,088 369,710
Note receivable 27,425 27,425
Inventories 523,042 511,408
Prepaid expenses 31,091 16,876
----------- ----------
Total current assets 953,274 1,141,733
Equipment:
Machinery and laboratory equipment 315,461 304,744
Furniture, fixtures and office equipment 245,415 238,761
----------- ----------
560,876 543,505
Accumulated depreciation and amortization (347,272) (328,421)
----------- ----------
Net equipment 213,604 215,084
Intangible assets:
Patents, net of accumulated amortization
of $590,409 and $572,484 in 1998
and 1997, respectively 527,135 545,060
Goodwill, net of accumulated amortization
of $33,412 and $32,523
in 1998 and 1997, respectively 28,176 29,065
----------- ----------
555,311 574,125
----------- ----------
Due from officer 12,000 12,000
Other assets 21,254 22,652
----------- ----------
Total assets $ 1,755,443 1,965,594
=========== ==========
Liabilities and Stockholders' Equity (Deficit)
Current liabilities:
Current portion of notes payable $ 277,217 287,765
Accounts payable 598,848 427,809
Accrued payroll and related liabilities 116,822 106,757
Other liabilities 48,472 116,054
----------- ----------
Total current liabilities 1,041,359 938,385
Notes payable, excluding current portion 842,974 853,349
----------- ----------
Total liabilities 1,884,333 1,791,734
Shareholders' equity (deficit):
Preferred stock, $0.001 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 June and 12,180,259
in September 12,180 12,102
Additional paid-in capital 3,609,743 3,610,798
Stock subscription receivable - (25,651)
Accumulated deficit (3,750,813) (3,423,389)
----------- ----------
Total stockholders' equity (deficit) (128,890) 173,860
----------- ----------
Total liabilities and stockholders'
equity (deficit) $ 1,755,443 1,965,594
=========== ==========
See accompanying notes to consolidated statements
</TABLE>
-3-
<PAGE>
<TABLE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
Consolidated Statements of Operations
- ---------------------------------------------------------------------------------------
<CAPTION>
Three Months Ended
September 30,
1998 1997
---- ----
(Unaudited)
<S> <C> <C>
Net sales $ 548,848 462,225
Cost of sales 282,677 281,618
------- -------
Gross profit 266,171 180,607
Operating expenses:
Selling and marketing 193,278 171,080
Research and development 97,715 86,904
General and administrative 278,281 218,999
------- -------
569,274 476,983
------- -------
Operating loss (303,103) (296,376)
Interest expense, net 24,321 18,156
------- -------
Net loss $ (327,424) (314,532)
======= =======
Net loss per share basic and diluted $ (0.03) (0.06)
Weighted average shares outstanding basic and diluted 12,156,591 4,891,650
See accompanying notes to consolidated financial statements.
</TABLE>
-4-
<PAGE>
<TABLE>
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARY
Consolidated Statements of Cash Flows
- -------------------------------------------------------------------------------------------
<CAPTION>
Three Months ended
September 30,
1998 1997
---- ----
(Unaudited)
<S> <C> <C>
Cash flows from operating activities:
Net loss $(327,424) (314,532)
Adjustments to reconcile net loss to net cash
used by operating activities:
Depreciation and amortization 37,665 32,558
Changes in operating assets and liabilities:
Accounts receivable 54,622 346,309
Inventories (11,634) (14,712)
Prepaid expenses and other assets (12,817) (5,481)
Accounts payable 171,039 (28,694)
Accrued payroll and related liabilities 10,065 (1,895)
Other liabilities (67,582) (34,645)
-------- --------
Net cash used by operating activities (146,066) (21,092)
-------- --------
Cash flows used by investing activities -
purchases of equipment (17,371) (5,355)
-------- --------
Cash flows from financing activities:
Payments on notes payable (20,923) (28,416)
Cash receipts on stock subscription 24,674 -
-------- --------
Net cash provided by (used by) financing activities 3,751 (28,416)
-------- -------
Net decrease in cash and cash equivalents (159,686) (54,863)
Cash and cash equivalents at beginning of period 216,314 141,086
-------- -------
Cash and cash equivalents at end of period $ 56,628 $ 86,223
======== =======
Supplemental disclosure -
cash paid for interest $ 25,476 $ 18,156
======== =======
See accompanying notes to consolidated financial statements.
</TABLE>
-5-
<PAGE>
CORGENIX MEDICAL CORPORATION AND SUBSIDIARY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Corgenix Medical Corporation (Corgenix or the Company) 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 quarters ended September 30, 1998 and 1997.
The accompanying consolidated financial statements have been prepared, without
audit, pursuant to the rules and regulations of the Securities and Exchange
Commission. Certain information and footnote disclosures normally included in
financial statements prepared in accordance with generally accepted accounting
principles have been condensed or omitted pursuant to such rules and
regulations. Although the Company believes that the disclosures are adequate to
make the information presented not misleading, it is suggested that these
consolidated financial statements be read in connection with the financial
statements and notes thereto included in the Company's annual report on Form
10-KSB for the year ended June 30, 1998.
In the opinion of the Company, the accompanying consolidated financial
statements include all adjustments (consisting of normal recurring accruals and
adjustments) required to present fairly the Company's financial position at
September 30, 1998 and June 30, 1998, and the results of its operations for each
of the three month periods ended September 30, 1998 and 1997, and the cash flows
for each of the three month periods then ended.
The operating results for the three months ended September 30, 1998 are not
necessarily indicative of the results that may be expected for the year ended
June 30, 1999.
2. LOSS PER SHARE
Basic and diluted loss per share is presented based on the weighted average
number of common shares outstanding during the period. The impact of warrants is
anti-dilutive due to losses and the exercise price of the warrants.
3. INCOME TAXES
The Company incurred losses in the three months ended September 30, 1998 and
1997. The Company has historically incurred losses and accordingly no tax
benefit is recognized as it is not more likely than not that tax losses will
result in a benefit to the Company.
-6-
<PAGE>
CORGENIX MEDICAL CORPORATION
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read in conjunction with the
financial statements and accompanying notes included elsewhere herein.
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.
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 relationship 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
Three Months Ended September 30, 1998 and 1997
Net Sales. Net sales for the three months ended September 30, 1998 were
$549,000, an 18.8% increase from $462,000 in 1997. A component of net sales,
gross product sales, increased 40.5% to $552,000 in 1998 from $393,000 in 1997,
because of an increase in the number of customers in the United States,
expansion of the international distribution network, and the market launch of
several new products.
Cost of sales. Cost of sales in dollars increased from $282,000 in 1997
to $283,000 in 1998. As a percentage of sales, cost of sales decreased from
61.0% in 1997 to 51.3% in 1998 mainly reflective of increased manufacturing
efficiencies and product mix changes to higher margin products. The gross profit
increased 47.0% from $181,000 in 1997 to $266,000 in 1998.
Research and development. Research and development expenses increased
12.6% to $98,000 in 1998 from $87,000 in 1997, due to costs related to increased
expense of new development programs.
Selling and marketing. Selling and marketing expenses increased 12.9%
from $171,000 in 1997 to $193,000 in 1998, primarily due to increased costs
associated with the Company's sales organization in Europe. As a percentage of
sales, selling and marketing expenses decreased from 37.0% to 35.2%.
-7-
<PAGE>
General and administrative. General and administrative expenses
increased 26.9% to $278,000 in 1998 from $219,000 in 1997, due in part to legal,
accounting and other costs relating to the Company becoming publicly traded.
Net loss. Net loss for the first quarter increased 4.1% from ($314,532)
in 1997 to ($327,424) in 1998.
LIQUIDITY AND CAPITAL RESOURCES
Since inception, Corgenix has financed its operations primarily through
private placements of common and preferred stock, raising net proceeds of
approximately $3.7 million from sales of these securities. Corgenix has also
received financing for operations from sales of diagnostic products and
agreements with strategic partners. Through September 30, 1998, Corgenix has
invested $214,000, (net of accumulated depreciation) in leasehold improvements,
laboratory and computer equipment and office furnishings and equipment to
support its development and administrative activities.
At September 30, 1998, the Company had cash of $56,628, a working
capital deficit of $119,176, and short and long-term notes payable of
$1,122,818, with $279,841 due in the following twelve months and the remainder
due at varying dates through February 2006.
Management expects that cash flows from current operations will be
insufficient to fund such operations. The Company is aggressively pursuing
financing alternatives to provide funds for its current operations and its
acquisition plans, which financing alternatives may involve accessing the public
equity or debt markets. There can be no assurance that the Company will be able
to obtain sufficient capital from such financings to offset its working capital
deficit or to pursue its expansion plans.
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 approximately $1.0 million in cash
and $1.2 million of restricted Common Stock. 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. The Company will be
required to access additional capital to fund the cash portion of this
acquisition, and there can be no assurance that this transaction will be
successfully consummated.
Under the terms of the merger agreement executed in connection of the
merger of REAADS Medical Products, Inc. ("REAADS") with and into a subsidiary of
the Company, the former shareholders of REAADS are entitled to receive up to an
additional 4,000,000 shares of Common Stock (the "Contingent Shares") upon the
non-occurrence of certain events by November 22, 1998. Because the Company does
not expect these events to have occurred by such date, the Company expects to
issue all such Contingent Shares on November 23, 1998. These Contingent Shares
will be restricted and will not be freely tradable until May 23, 1999.
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 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
expects to fund such costs from working capital.
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 who 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
-8-
<PAGE>
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 for 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 report 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 report, 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 report 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 flows from
operations for the last three fiscal years and for the first quarter of the
current fiscal year. Losses incurred by the Company since its inception have
aggregated over $3.5 million, and there can be no assurance that the Company
will be able to generate positive cash flows to fund its operations in the near
future. In addition, the Company's current acquisition plans will require the
investment of approximately $1.0 million of cash. The Company is aggressively
pursuing financing alternatives to provide funds for its current operations and
its acquisition plans, which financing alternatives may involve accessing the
public equity or debt markets. There can be no assurance that the Company will
be able to obtain sufficient capital from such financings to offset its working
capital deficit or to pursue its expansion plans, or that the terms of
available financing will be satisfactory to the Company. Alternatively, any
additional equity financing may be dilutive to existing stockholders, and debt
financing, if available, may include restrictive covenants or conversion
features that are dilutive to existing stockholders. 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 and 1998. 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 in the 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
-9-
<PAGE>
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."
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.
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.
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 Food and
Drug Administration (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.
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
-10-
<PAGE>
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
point-of-care 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 quality system regulations ("QSR"), 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 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 approvals 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. 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.
-11-
<PAGE>
Risks Regarding Potential Future Acquisitions
The Company's growth strategy includes as a material element the desire
to acquire complementary companies, products or technologies. As discussed in
"-- Liquidity and Capital Resources," the Company has executed a letter of
intent to acquire the assets of one diagnostic technology business. The Company
has not targeted any other 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 without accessing outside
financing, 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.
See "-- Losses Incurred; Future Capital Needs; Uncertainty of Additional
Funding." 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.
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 products.
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 its 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
-12-
<PAGE>
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.
Limited Public Market; 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(R) 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, and the Company's stock price has
experienced significant price and volume fluctuations in the past. 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.
Finally, the Company expects to issue 4,000,000 Contingent Shares to the
former REAADS shareholders on November 23, 1998. See "--Liquidity and Capital
Resources." Although these shares will be restricted and will not be freely
tradeable until May 23, 1999, the issuance of these Contingent Shares may have
the effect of depressing the market price of the Common Stock both prior to and
after the lapse of such restrictions.
-13-
<PAGE>
CORGENIX MEDICAL CORPORATION
PART II
OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Corgenix is not a party to any material litigation or legal proceedings.
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
On July 28, 1998, the Company completed the sale of 77,765 shares of its
Common Stock that had been subscribed for in a previously reported Rule 504
private placement transaction. Such sale was made at a price of $0.317 per share
to a single investor, who is a consultant to the Company. This sale was 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. At the time of the
completion of this sale, the Company was not a reporting company under either
the Securities Act of 1933, as amended, 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 total amount of securities offered and sold in the Rule 504
private placement transaction, including the shares issued in July 1998, was
within the regulatory maximum permitted by Rule 504.
The Company used the net proceeds of this sale, which were $24,651, for
working capital.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of the Company's security holders
during the period covered by this report.
ITEM 5. OTHER INFORMATION
On November 10, 1998, Mike M. Mustafoglu resigned as a director of the
Company. Mr. Mustafoglu has informed the Company that his resignation was not
due to a disagreement with the Company on any matter relating to the Company's
operations, policies or practices.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
-14-
<PAGE>
EXHIBIT
NUMBER DESCRIPTION OF EXHIBIT
- ------ ----------------------
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 4.1 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).
-15-
<PAGE>
10.7 Product Development and Manufacturing Agreement dated September 12,
1994 between REAADS 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. (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).
-16
<PAGE>
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)
(certain portions of Exhibit 10.23 have been omitted based upon a
request for confidential treatment; the omitted portions have been
filed with the Commission).
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).
11.1* Statement Regarding Computation of Net Income per Share.
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).
27* Financial Data Schedule
- -------------------------------
* Filed herewith.
(b) Reports on Form 8-K.
None
-17-
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
CORGENIX MEDICAL CORPORATION
November 16, 1998 By: /s/ Luis R. Lopez
-------------------------
Luis R. Lopez, M.D.
Chairman and Chief Executive Officer
-18-
<TABLE>
CORGENIX MEDICAL CORPORATION
COMPUTATION OF NET INCOME PER SHARE
<CAPTION>
Three Months Ended
September 30,
1998 1997
---- ----
<S> <C> <C>
Net loss........................................... $ (327,424) $ (314,532)
============ ============
Common shares outstanding at beginning of period... 12,102,494 4,837,170
Effect of shares issued during the period..... 54,097 54,480
------------ ------------
Basic and diluted weighted average common shares... 12,156,591 4,891,650
Basic and diluted loss per share................$ (0.03) $ (0.06)
</TABLE>
<TABLE> <S> <C>
<ARTICLE> 5
<MULTIPLIER> 1,000
<CURRENCY> U.S. DOLLARS
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> JUN-30-1998
<PERIOD-START> JUL-1-1998
<PERIOD-END> SEP-30-1998
<EXCHANGE-RATE> 1
<CASH> 57
<SECURITIES> 0
<RECEIVABLES> 322
<ALLOWANCES> 7
<INVENTORY> 523
<CURRENT-ASSETS> 953
<PP&E> 561
<DEPRECIATION> 347
<TOTAL-ASSETS> 1,755
<CURRENT-LIABILITIES> 1,041
<BONDS> 0
0
0
<COMMON> 12
<OTHER-SE> (141)
<TOTAL-LIABILITY-AND-EQUITY> 1,755
<SALES> 552
<TOTAL-REVENUES> 549
<CGS> 283
<TOTAL-COSTS> 777
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 25
<INCOME-PRETAX> (327)
<INCOME-TAX> 0
<INCOME-CONTINUING> (327)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (327)
<EPS-PRIMARY> (0.03)
<EPS-DILUTED> (0.03)
</TABLE>
