UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-QSB
X QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2001
_ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE 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
incorporation or organization) No.)
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 X No ___
-
The number of shares of Common Stock outstanding was 21,525,615 as of November
13, 2001.
Transitional Small Business Disclosure Format. Yes _ No X
-
CORGENIX MEDICAL CORPORATION
September 30, 2001
TABLE OF CONTENTS
Page
Part I
Financial Information
Item 1. Consolidated Financial Statements 3
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations 9
Part II
Other Information
Item 1. Legal Proceedings 17
Item 2. Changes in Securities and Use of Proceeds 17
Item 3. Defaults Upon Senior Securities 17
Item 4. Submission of Matters to a Vote of Security Holders 17
Item 5. Other Information 17
Item 6. Exhibits and Reports on Form 8-K 17
PART I
Item 1. Consolidated Financial Statements
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARIES
Consolidated Balance Sheets
- -------------------------------------------------------------------------------
September 30, 2001 June 30, 2001
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $353,098 320,140
Accounts receivable, less allowance for
doubtful accounts of $14,000 614,652 585,704
Inventories 622,497 556,521
Prepaid expenses 33,317 13,612
Total current assets 1,623,564 1,475,977
Equipment:
Machinery and laboratory equipment 353,549 353,549
Software, furniture, fixtures
and office equipment 1,012,696 1,010,631
----------- ---------
1,366,245 1,364,180
Accumulated depreciation and
amortization (621,807) (551,393)
---------
Net equipment 744,438 812,787
Intangible assets:
Patents, net of accumulated
amortization of $814,610 and
$795,986, respectively 302,934 321,558
Goodwill, net of accumulated
amortization of $42,045 and
$41,067, respectively 16,611 17,589
------ ------
Net intangible assets 319,545 339,147
------- --------
Due from officer 12,000 12,000
Other assets 61,072 65,179
------ --------
Total assets
$2,760,619 2,705,090
=============== ===============
Liabilities and Stockholders' Equity (Deficit)
Current liabilities:
Current portion of notes payable $ 184,677 188,998
Current portion of capital lease
obligation 42,707 31,186
Accounts payable 527,647 746,642
Accrued payroll and related liabilities 121,298 141,528
Accrued interest payable 91,093 82,689
Other liabilities 103,775 72,642
Employee stock purchase plan payable 2,651 2,235
-------- ------
Total current liabilities 1,073,848 1,265,920
Notes payable, excluding current portion 591,611 618,370
Capital lease obligation, excluding
current portion 65,790 49,379
------ -------
Total liabilities 1,731,249 1,933,669
Stockholders' equity (deficit):
Preferred stock, $0.001 par value.
Authorized 5,000,000 shares, none
issued or outstanding - -
Common stock, $0.001 par value.
Authorized 40,000,000 shares; issued and
outstanding 21,406,230 and 20,386,448
on September 30 and June 30, respectively 21,406 20,386
Additional paid-in capital 4,628,761 4,459,254
Accumulated deficit (3,637,993) (3,736,486)
Accumulated other comprehensive income 17,196 28,267
------ ---------
Total stockholders' equity 1,029,370 771,421
--------- --------
Total liabilities and stockholders'
equity $2,760,619 2,705,090
=========== ===========
See accompanying notes to consolidated financial statements.
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARIES
Consolidated Statements of Operations
- -------------------------------------------------------------------------------
Three Months Ended
September 30, September 30,
2001
2000
-------------------------------
(Unaudited) (Unaudited)
Net sales $ 1,151,062 908,731
Cost of sales 316,669 338,330
-------------------------------
Gross profit $ 834,393 570,401
Operating expenses:
Selling and marketing 235,240 187,234
Research and development 138,721 88,677
General and
administrative 327,087 162,738
-------------------------------
Total expenses 701,048 438,649
Operating income $ 133,345 131,752
Interest expense, net 34,852 29,014
-------------------------------
Net income $ 98,493 102,738
------------- ------------
Net income per share,
basic $ 0.01 0.01
Net income per share,
diluted $ 0.01 0.01
Weighted average shares
outstanding, basic 20,967,881 17,423,538
Weighted average shares
outstanding, diluted 21,287,303 17,425,114
========== ==========
Net income 98,493 102,738
Other comprehensive
income (loss)- foreign
currency translation
gain (loss) (11,071) 4,930
----------- --------
Total comprehensive income 87,422 107,668
============ =========
See accompanying notes to consolidated financial statements.
CORGENIX MEDICAL CORPORATION
AND SUBSIDIARIES
Consolidated Statements of Cash Flows
- -------------------------------------------------------------------------------
Three Months
Ended
September 30, September 30,
2001 2000
-------------------------------
(Unaudited)
Cash flows from operating activities:
Net income $ 98,493 102,738
Adjustments to reconcile net income
to net cash provided by operating
activities:
Depreciation and amortization 90,016 35,173
Equity instruments issued
for services 10,619 1,770
Changes in operating assets and liabilities:
Accounts receivable (28,948) 68,117
Inventories (65,976) 19,371
Prepaid expenses and other assets (15,598) (509,463)
Accounts payable (218,995) (29,233)
Accrued payroll and related liabilities (20,230) 10,578
Employee stock purchase plan payable 416 2,027
Accrued interest and
other liabilities 39,537 (142,548)
-----------------------------
Net cash used by operating
activities (110,666) (441,470)
-----------------------------
Cash flows used by investing activities:
Purchase of equipment (2,065) 436,758
-----------------------------
Net cash provided
(used) by investing activities (2065) 436,758
-----------------------------
Cash flows from financing activities:
Proceeds from issuance of common stock 175,615 -
Proceeds from issuance of notes payable 1,334 -
Additions to capital lease obligations 40,000 -
Payments on notes payable (32,414) (30,038)
Payments on capital lease obligations (12,068) (5,347)
Payments for costs of issuance of
common stock (15,707) -
-----------------------------
Net cash provided (used)
by financing activities 156,760 (35,385)
-----------------------------
Net increase (decrease) in
cash and cash equivalents 44,029 (40,097)
Impact of foreign currency translation
adjustment on cash (11,071) 4,930
Cash and cash equivalents at beginning
of period 320,140 46,698
----------------------------
Cash and cash equivalents at end of
period $ 353,098 11,531
============================
Supplemental cash flow disclosures:
Cash paid for interest $ 19,858 29,014
Noncash investing and financing
activity--
Equipment acquired under capital leases $ - 27,858
----------------------------
See accompanying notes to consolidated financial statements.
CORGENIX MEDICAL CORPORATION AND SUBSIDIARIES
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.
We market our products to hospitals and free-standing laboratories worldwide
through a network of sales representatives, distributors, and private label
(OEM) agreements. Our headquarter offices and manufacturing facility are located
in Westminster, Colorado.
The consolidated financial statements include the accounts of the Company
and its wholly owned subsidiaries, Corgenix, Inc., Corgenix UK Limited (Corgenix
UK) and health-outfitters.com, Inc. Corgenix UK was established as a United
Kingdom company during 1996 to market the Company's products in Europe.
Transactions are generally denominated in US dollars
The accompanying consolidated financial statements have been prepared
without audit and in accordance with generally accepted accounting principles
for interim financial information and with the instructions to Form 10-QSB and
Article 10 of Regulation S-X. Accordingly, they do not include all of the
information and footnotes required by generally accepted accounting principles
for complete financial statements. In the opinion of the Company, the financial
statements include all adjustments (consisting of normal recurring accruals and
adjustments) required to present fairly the Company's financial position at
September 30, 2001 and June 30, 2001 and the results of operations for each of
the three month periods ended September 30, 2001 and 2000, and the cash flows
for each of the three month periods then ended. The operating results for the
three months ended September 30, 2001 are not necessarily indicative of the
results that may be expected for the year ended June 30, 2002. For further
information, refer to the consolidated financial statements and footnotes
thereto included in the Company's annual report on Form 10-KSB for the fiscal
year ended June 30, 2001.
2. SOFTWARE
In the year ended June 30, 2000 we began development of a web site
for selling healthcare and fitness products directly to consumers. The internal
and external costs of developing and enhancing the software, other than initial
design and other costs incurred during the preliminary project stage, were
capitalized through the fourth fiscal quarter of the fiscal year ended June 30,
2001. To date, all products and enhancements thereto have utilized proven
technology. Such capitalized amounts are amortized on the straight-line method
over the estimated economic life, estimated to be three years beginning July 1,
2001. Although it is possible that management's estimate for the future net
realizable value could change in the near future, management is not currently
aware of any events that would result in a change to its estimate which would be
material to our financial position or our results of operations.
3. EARNINGS PER SHARE
Basic and diluted net income per share is presented based on the weighted
average number of common shares outstanding during the period. Diluted net
income per share is computed on the basis of the weighted average number of
common shares outstanding plus the effect of outstanding warrants and stock
options using the "treasury stock" method unless the impact is anti-dilutive.
The difference between basic income per share and diluted income per share is
due to the effect of outstanding warrants and stock options. For the three
months ended September 30, 2001 and 2000, the dilutive effect of outstanding
warrants and stock options would have been 319,422 and 1,576, respectively.
The components of basic and diluted income (loss) per share are as
follows:
3 months 3 months
ended ended
September 30, 2001 September 30, 2000
Numerator:
Net income available to common
stockholders $ 98,493 102,738
============== =============
Denominator:
Historical common shares outstanding 20,386,448 17,416,562
Weighted average number of common
equivalent shares issued during
the period 581,433 6,976
--------------- --------------
Denominator for basic income per
share - weighted average shares 20,967,881 17,423,538
Incremental common shares
attributable to shares issuable
under equity incentive plans
(Treasury Stock Method) 319,422 1,576
Denominator for diluted net
income per share - weighted
average shares 21,287,303 17,425,114
Basic income per share
$ 0.01 0.01
Diluted earnings (loss) per share
$ 0.01 0.01
============== ==============
4. INCOME TAXES
The Company recognized net income in the three months ended September 30,
2001. Although the Company recognized net income in the years ended June 30,
2001 and 2000, it historically has incurred losses, and accordingly no net
income tax benefit has been recognized. The Company will continue to assess when
it is appropriate to reverse some or all of the valuation allowance for deferred
income taxes based on projecting net income in the future or tax planning
strategies.
5. SEGMENT INFORMATION
The Company has two segments of business: the Domestic segment, which
includes revenues generated by sales to customers in the United States, Canada,
Mexico and Japan, and includes all expenses in the Denver, Colorado headquarters
including corporate expenses; and the International segment, which includes
sales to customers worldwide except for those covered in the North America and
Japan segment, and includes all expenses of the Corgenix subsidiary in the UK.
The Company's other subsidiary, health-outfitters.com, Inc. had insignificant
revenue for the three months ended September 30, 2001 and no revenue for the
three months ended September 30, 2000. The expenses for health-outfitters.com,
Inc., are included in the Domestic segment. The following table sets forth
selected financial data for these segments for the three month periods ended
September 30, 2001 and 2000.
Three Months Ended September 30
Domestic International Total
Revenues 2001 $ 841,446 309,616 1,151,062
2000 $ 688,245 220,486 908,731
----------------------------------------------------
----------------------------------------------------
Gross Profit
2001 $ 609,296 225,097 834,393
2000 $ 496,561 73,840 570,401
----------------------------------------------------
----------------------------------------------------
Net income
(loss) 2001 $ (71,610) 170,103 98,493
2000 $ 63,968 38,770 102,738
----------------------------------------------------
----------------------------------------------------
Depreciation
and Amortization
2001 $ 90,016 0 90,016
2000 $ 65,173 0 65,173
----------------------------------------------------
----------------------------------------------------
Interest
expense 2001 $ 28,262 6,590 34,852
2000 $ 24,989 4,025 29,014
----------------------------------------------------
----------------------------------------------------
Long-lived
assets 2001 $1,005,342 8,981 1,014,323
2000 $1,105,586 11,145 1,116,731
----------------------------------------------------
Item 2.
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
consolidated financial statements and accompanying notes included elsewhere
herein.
General
Since the Company's inception, we have been primarily involved in the
research, development, manufacturing and marketing/distribution of diagnostic
tests for sale to clinical laboratories. We currently market 142 products
covering autoimmune disorders, vascular diseases, infectious diseases and liver
disease. Our products are sold in the United States, the UK and other countries
through our marketing and sales organization that includes contract sales
representatives, internationally through an extensive distributor network, and
to several significant OEM partners.
We manufacture products for inventory based upon expected sales demand,
shipping products to customers, usually within 24 hours of receipt of orders.
Accordingly, we do not operate with a backlog.
Except for the fiscal year ending June 30, 1997, we have experienced
revenue growth since our 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, we began adding third-party OEM licensed
products to our diagnostic product line. Currently we sell 128 products licensed
from or manufactured by third party manufacturers. We expect to expand our
relationships with other companies in the future to gain access to additional
products.
Although we have experienced growth in revenues every year except for
1997, there can be no assurance that, in the future, we will sustain revenue
growth or maintain profitability. Our 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 we receive R&D milestone payments and license fees
from strategic partners, (v) changes in reimbursement policies for the products
that we sell, (vi) competitive pressures on average selling prices for the
products that we sell, (vii) changes in the mix of products that we sell, and
(viii) the acceptance by consumers of e-commerce in the sale of health products.
Results of Operations
Three Months Ended September 30, 2001 compared to 2000
Net sales. Net sales for the three months ended September 30, 2001 were
$1,151,062, a 26.7% increase from $908,731 in 2000 due to continued expansion of
our worldwide distribution network, overall product mix, and the revenue
contribution of new products. Product sales increased in all categories.
Domestic sales increased 22.1%; sales to international distributors increased
40.4%; and sales to OEM partners increased 105.3%, primarily due to ordering
patterns and to sales to new OEM partners. Included in the above increase in
Domestic sales was an increase of 101.1% in the sales of Hyaluronic Acid to
Chugai for distribution in Japan. Chugai is the Company's largest customer,
representing approximately 17% and 10% of sales in the quarter ended September
30, 2001 and 2000, respectively. The majority of the Company's sales increase
for the current fiscal quarter was due to higher unit volume (which increased in
excess of 19%), as opposed to increases in average price per unit sold (which
increased 14.6%). Sales of products manufactured for us by other companies,
while still relatively small, are expected to continue to increase during fiscal
2002. Sales of products by health-outfitters.com were not significant in the
first fiscal quarter and, since we envision a slow-growth scenario, are not
expected to be significant in fiscal year 2002.
Cost of sales. Cost of sales was consistent in the first quarter to last
year's first quarter due to increased sales of newer, higher margin products.
Selling and marketing. Selling and marketing expenses increased 25.6 % to
$235,240 for the three months ended September 30, 2001 from $187,234 in 2000 due
to increases in advertising and labor-related expense.
Research and development. Research and development expenses, for the three
months ended September 30, 2001, increased 56.5% to $138,721 from $88,677 in
2000. Most of this increase came as a result of increased labor-related costs
and purchases and development costs of new products, most notably a joint proof
of principle development project. In addition, the Company had greater research
and development costs associated with the end of a product development cycle
with respect to the anti-prothrombin product introduction.
General and administrative. General and administrative expenses, for the
three months ended September 30, 2001, increased 101% to $327,087 from $162,738
in 2000, due to the amortization of software development costs, the expense of
health outfitters.com web site and to increases in payroll-related costs in
addition to outside services expense such as legal, accounting and consulting
expenses.
Interest expense. Interest expense increased 20.1% to $34,852 in 2001 from
$29,014 in 2000 due primarily to an increase in capital lease obligations.
Liquidity and Capital Resources
Cash used by operating activities was $116,867 for the current fiscal
quarter compared to $441,470 during the prior fiscal year's comparable quarter.
The useage for the latest quarter was primarily attributable to the Company's
investment in working capital resulting in an increase in accounts receivable,
inventory and prepaid expenses, along with a substantial reduction in accounts
payable. The Company expects this trend to continue as its revenues increase.
The Company believes that uncollectible accounts receivable will not have a
significant effect on future liquidity, as a significant portion of its accounts
receivable are due from enterprises with substantial financial resources.
Net cash used by investing activities, the purchase of equipment, was
$2,065 for the current fiscal quarter . The useage in the current quarter was
mainly attributable to the addition of laboratory and computer equipment
required by the Company.
Net cash provided by financing activities amounted to $156,760 for the
current fiscal quarter. This increase in cash provided was primarily due to the
private sale of the Company's common stock, referred to above, amounting to a
net amount realized of $159,908.
Historically, we have financed our operations primarily through sales of
common and preferred stock. In fiscal 2001, we raised $496,316 before offering
expenses through a private sale of common stock.
We have also received financing for operations from sales of diagnostic
products and agreements with strategic partners. As of September 30, 2001, our
accounts payable decreased 29.3% to $527,647 from $746,642 as of June 30, 2001
due to a concerted effort on our part to bring the accounts payable more
current. Although sales increased 26.7% for the current fiscal quarter compared
to the same quarter in the prior year, accounts receivable only increased 4.9%
to $614,652 as of September 30, 2001 from $585,704 as of June 30, 2001,
primarily because of more timely payment by our customers.
Our principal sources of liquidity have been cash provided from operating
and financing activities, cash raised from the private sale of common stock
mentioned above, and long-term debt financing, of which $695,538 remained
outstanding as of September 30, 2001. We believe that we will continue
investigating new debt agreements and may sell additional equity securities in
fiscal year 2002 to develop the markets and obtain the regulatory approvals for
the HA products, and to pursue all of our strategic objectives. We believe that
our current availability of cash and working capital are adequate to meet our
ongoing needs for at least the next twelve months.
On June 30, 2001, the Financial Accounting Standards Board ("FASB or "the
Board") issued Statement of Financial Accounting Standards ("SFAS") No. 141,
"Business Combinations", and SFAS No. 142, "Goodwill and Intangible Assets".
Major provisions of these Statements are as follows: all business combinations
initiated after June 30, 2001 must use the purchase method of accounting; the
pooling of interest method of accounting is prohibited except for transactions
initiated before July 1, 2001; intangible assets acquired in a business
combination must be recorded separately from goodwill if they arise from
contractual or other legal rights or are separable from the acquired entity and
can be sold, transferred, licensed, rented or exchanged, either individually or
as part of a related contract, asset or liability; goodwill and intangible
assets with indefinite lives are not amortized but are tested for impairment
annually, except in certain circumstances, and whenever there is an impairment
indicator; all acquired goodwill must be assigned to reporting units for
purposes of impairment testing and segment reporting; and goodwill will no
longer be subject to amortization. Although it is still reviewing the provisions
of these Statements, management's preliminary assessment is that the impact of
these Statements on the Company's consolidated financial statements is expected
to be immaterial.
The Company is required and plans to adopt the provisions of Statement No.
143 for the quarter ending September 30, 2002. To accomplish this, the Company
must identify all legal obligations for asset retirement obligations, if any,
and determine the fair value of these obligations on the date of adoption. The
determination of fair value is complex and will require the Company to gather
market information and develop cash flow models. Additionally, the Company will
be required to develop processes to track and monitor these obligations. Because
of the effort necessary to comply with the adoption of Statement No. 143, it is
not practicable for management to estimate the impact of adopting this Statement
at the date of this report.
On October 3, 2001, the Board issued FASB Statement No. 144, Accounting
for the Impairment or Disposal of Long-Lived Assets, which addresses
financial accounting and reporting for the impairment or disposal of
long-lived assets. While Statement No. 144 supersedes FASB Statement No.
121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived
Assets to Be Disposed Of, it retains many of the fundamental provisions of
that Statement. Statement No. 144 also supersedes the accounting and
reporting provisions of APB Opinion No. 30, Reporting the Results of
Operations-Reporting the Effects of Disposal of a Segment of a Business, and
Extraordinary, Unusual and Infrequently Occurring Events and Transactions,
for the disposal of a segment of a business. The Company does not expect the
impact of adopting SFAS Nos. 144 to be significant.
Forward-Looking Statements and Risk Factors
This 10-QSB 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 our expectations,
beliefs, intentions or strategies regarding the future. All statements other
than historical fact contained in this 10-QSB, including, without limitation,
statements regarding future product developments, statements regarding our
intent to develop a consumer products business, acquisition strategies,
strategic partnership expectations, technological developments, the development,
launch and operation of health-outfitters.com, the availability of necessary
components, research and development programs and distribution plans, are
forward-looking statements. All forward-looking statements included in this
10-QSB are based on information available to us on the date hereof, and we
assume no obligation to update such forward-looking statements. Although we
believe that the assumptions and expectations reflected in such forward-looking
statements are reasonable, we can give no assurance that such expectations will
prove to have been correct or that we 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; Risks Relating to the
Professional Products Business; Uncertainty of Additional Funding
We have incurred operating losses and negative cash flow from operations
for most of our history. Losses incurred since our inception have aggregated
$3,637,993, and there can be no assurance that we will be able to generate
positive cash flows to fund our operations in the future or to pursue our
strategic objectives. Assuming no significant uses of cash in acquisition
activities or other significant changes, we believe that we will have sufficient
cash to satisfy our needs for at least the next year. If we are not able to
operate profitably and generate positive cash flows sufficient for both the
diagnostic business and the consumer products business, we may need to raise
additional capital to fund our operations. If we need additional financing to
meet our requirements, there can be no assurance that we will be able to obtain
such financing on terms satisfactory to us, 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, we might be required to limit our research and development
activities, our selling and marketing activities or our plans to develop the
Consumer Products Business, any of which could have a material adverse effect on
the future of the business.
Dependence on Collaborative Relationships and Third Parties for Product
Development and Commercialization
We have historically entered into licensing and research and development
agreements with collaborative partners, from which we derived a significant
percentage of our revenues in past years. Pursuant to these agreements, our
collaborative partners have specific responsibilities for the costs of
development, promotion, regulatory approval and/or sale of our products. We will
continue to rely on future collaborative partners for the development of
products and technologies. There can be no assurance that we will be able to
negotiate such collaborative arrangements on acceptable terms, if at all, or
that current or future collaborative arrangements will be successful. To the
extent that we are not able to establish such arrangements, we could experience
increased capital requirements or be forced to undertake such activities at our
own expense. The amount and timing of resources that any of these partners
devotes to these activities will generally be based on progress by us in our
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 our ability to deliver products on a timely basis.
No Assurance of Successful or Timely Development of Additional Products
Our business strategy includes the development of additional diagnostic
products both for the diagnostic business and consumer products business. Our
success in developing new products will depend on our 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. We 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 we are 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, our results of operations 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. Our 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 ours. 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 our technologies.
Competition in the E-commerce Industry
Competition in the e-commerce industry is, and is expected to remain,
significant. The competitors for the new business range from development stage
internet companies to divisions of larger companies. Many of these companies
have financial, marketing, sales, manufacturing, distribution and other
resources significantly greater than those of us. In addition, many of these
companies have name recognition, established positions in the market and
existing relationships with customers and distributors.
Governmental Regulation of Diagnostics Products
The testing, manufacture and sale of our 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 there under, the FDA regulates the preclinical and
clinical testing, manufacture, labeling, distribution and promotion of medical
devices. We are not able to commence marketing or commercial sales in the United
States of new products under development until we receive 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 we will be able to obtain necessary
regulatory approvals or clearances for our 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 our business.
Dependence on Distribution Partners for Sales of Diagnostic Products in
International Markets
We have entered into distribution agreements with collaborative partners
in which we have granted distribution rights for certain of our products to
these partners within specific international geographic areas. Pursuant to these
agreements, our 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 our business, financial condition and
results of operations.
Governmental Regulation of Manufacturing and Other Activities
As a manufacturer of medical devices for marketing in the United States,
we are required to adhere to applicable regulations setting forth detailed good
manufacturing practice requirements, which include testing, control and
documentation requirements. We 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. We are 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. We may incur significant costs
to comply with laws and regulations in the future, which may have a material
adverse effect upon our 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. We may be required to incur significant costs in obtaining or
maintaining foreign regulatory approvals. In addition, the export of certain of
our products that have not yet been cleared for domestic commercial distribution
may be subject to FDA export restrictions. Failure to obtain necessary
regulatory approval or the failure to comply with regulatory requirements could
have a material adverse effect on our 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 product. Decreases in reimbursement amounts for tests
performed using our 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 our ability to sell our diagnostic products
profitably. Market acceptance of our 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
Our success depends, in part, on our 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
our issued patents will afford meaningful protection against a competitor, or
that patents issued to us will not be infringed upon or designed around by
others, or that others will not obtain patents that we would need to license or
design around. We could incur substantial costs in defending the Company or our
licensees in litigation brought by others. Our business could be adversely
affected.
Risks Regarding Potential Future Acquisitions
Our growth strategy includes the desire to acquire complementary
companies, products or technologies. There is no assurance that we will be able
to identify appropriate companies or technologies to be acquired, to negotiate
satisfactory terms for such an acquisition, or to obtain sufficient capital to
make such acquisitions. Moreover, because of limited cash resources, we will be
unable to acquire any significant companies or technologies for cash and our
ability to effect acquisitions in exchange for our capital stock may depend upon
the market prices for our Common Stock. If we do complete one or more
acquisitions, a number of risks arise, such as short-term negative effects on
our 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 our business, financial condition
and results of operations.
Dependence on Suppliers
The components of our products include chemical and packaging supplies
that are generally available from several suppliers, except certain antibodies,
which we purchases from single suppliers. We mitigate the risk of a loss of
supply by maintaining a sufficient supply of such antibodies to ensure an
uninterrupted supply for at least three months. We have also qualified second
vendors for all critical raw materials and believe that we can substitute a new
supplier with respect to any of these components in a timely manner. However,
there can be no assurances that we will be able to substitute a new supplier in
a timely manner and failure to do so could have a material adverse effect on our
business, financial condition and results of operations.
Limited Manufacturing Experience with Certain Products
Although we have manufactured over twelve million diagnostic tests based
on our proprietary applications of ELISA (enzyme linked immuno-absorbent assay)
technology, certain of our diagnostic products in consideration for future
development, incorporate technologies with which we have little 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
Our revenue and operating results have historically been minimally subject
to quarterly fluctuations. There can be no assurance that such seasonality in
our results of operations will not have a material adverse effect on our
business.
Dependence on Key Personnel
Because of the specialized nature of our business, our success will be
highly dependent upon our ability to attract and retain qualified scientific and
executive personnel. In particular, we believe our 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 we 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 our 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, we have
experienced no product liability claims, but any such claims arising in the
future could have a material adverse effect on our business, financial condition
and results of operations. Our product liability insurance coverage is currently
limited to $2 million. Potential product liability claims may exceed the amount
of our insurance coverage or may be excluded from coverage under the terms of
our policy or limited by other claims under our umbrella insurance policy.
Additionally, there can be no assurance that our existing insurance can be
renewed by us at a cost and level of coverage comparable to that presently in
effect, if at all. In the event that we are held liable for a claim against
which we are not insured or for damages exceeding the limits of our insurance
coverage, such claim could have a material adverse effect on our business,
financial condition and results of operations.
Risks Related to the Consumer Products Business
New Business Strategy
We established a new wholly owned subsidiary, health-outfitters.com, Inc.,
in December 1999. This subsidiary is focused on sales of consumer healthcare
products primarily through e-commerce using our websites,
www.healthoutfitters.com and www.sports-n-fitness.com. We do not have any
experience in managing internet businesses, and we may not be able to
successfully operate and grow this new business. The demands of attempting to
grow this new business may prevent management from devoting time and attention
to our traditional diagnostic business, and that traditional business may
decline.
The e-commerce healthcare market is a relatively new and unproven
business. Whether we succeed depends upon broad acceptance of internet-based
healthcare product purchasing, as well as our ability to generate brand
awareness and vendor relationships.
Competition in the e-commerce industry is, and is expected to remain,
significant. The competitors for the new business range from development stage
internet companies to divisions of larger companies. Many of these companies
have financial, marketing, sales, manufacturing, distribution and other
resources significantly greater than those of us. In addition, many of these
companies have name recognition, established positions in the market and
existing relationships with customers and distributors.
Other Risks
Limited Public Market; Possible Volatility in Stock Prices; Penny Stock
Rules
There has, to date, been no active public market for our Common Stock, and
there can be no assurance that an active public market will develop or be
sustained. Although our 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 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 our industry and the investment
markets and economic conditions generally, as well as quarterly variation in our
results of operations, may adversely affect the market price of our Common
Stock. In addition, our 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 our Common Stock because of the added
disclosure requirements.
Risks Associated with Exchange Rates
Our financial statements are presented in US dollars. At the end of each
fiscal quarter and the fiscal year, we convert the financial statements of
Corgenix UK, which operates in pounds sterling, into US dollars, and consolidate
them with results from Corgenix, Inc. and health-outfitters.com, Inc. We may,
from time to time, also need to exchange currency from income generated by
Corgenix UK. Foreign exchange rates are volatile and can change in an unknown
and unpredictable fashion. Should the foreign exchange rates change to levels
different than anticipated by us, our business, financial condition and results
of operations may be materially adversely affected.
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
From July 1, 2001 through September 30, 2001, we sold a total of
1,001,000 shares of Common Stock at $.17544 per share for a total of $175,615 to
11 accredited investors. The sales were made in reliance upon the exemption from
the registration requirements of the Securities Act of 1933, as amended,
provided by Section +4 (2) of the Securities Act. The shares were not registered
under federal or state securities laws, and, therefore, will be "restricted
securities" as such term is defined in Rule 144 promulgated under the Securities
Act. The Company intends to use the proceeds of the private placement to assist
in the market and regulatory development of the Company's HA diagnostic test,
acquire capital equipment, reduce short-term debt, accelerate research and
development of new products and for general working capital.
Item 3. Defaults Upon Senior Securities
None
Item 4. Submission of Matters to a Vote of Security Holders
The Registrant's annual meeting of stockholders will be held on December 11,
2001. No matters were submitted to a vote of the Company's security holders
during the period covered by this report.
Item 5. Other Information
None
Item 6. Exhibits and Reports on Form 8-K.
a. Index to and Description of Exhibits
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.
3.3 Articles of Incorporation of health-outfitters.com, Inc.
dated November 16, 1999 (filed as Exhibit 3.3 to the
Company's filing on Form 10-QSB for the fiscal quarter
ended December 31, 1999).
3.4 Bylaws of health-outfitters.com, Inc. dated November 16,
1999 (filed as Exhibit 3.4 to the Company's filing on Form
10-QSB for the fiscal quarter ended December 31, 1999).
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 to 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 License Agreement dated June 30, 2001 between Chugai
Diagnostic Science Co., Ltd. and Corgenix Medical
Corporation.
10.9 Office Lease dated May 5, 2001 between Crossroads West LLC/Decook
Metrotech LLC and Corgenix, Inc.
10.10 Guarantee dated November 1, 1997 between William George Fleming,
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 April 1, 2001 between Luis R.
Lopez and the Company.
10.12 Employment Agreement dated April 1, 2001 between Douglass
T. Simpson and the Company.
10.13 Employment Agreement dated April 1, 2001 between Ann L.
Steinbarger and the Company.
10.14 Employment Agreement dated April 1, 2001 between Taryn G.
Reynolds and the Company.
10.15 Employment Agreement dated April 1, 2001 between Catherine (O'Sullivan)
Fink and the Company.
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).
10.19 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).
10.24 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).
10.27 Warrant agreement dated June 1, 2000 between the Company
and Taryn G. Reynolds.
10.30 Employment Agreement dated March 1, 2001 between William H. Critchfield
and the Company (filed as Exhibit 10.30 to the Company's filing on Form
10-QSB for the fiscal quarter ended March 31, 2001).
10.31 Consulting Agreement dated April 10,2001 between Bathgate McColley
Capital Group, LLC and the Company.
10.32 Warrant Agreement dated April 10, 2001 between Bathgate McColley
Capital Group, LLC and the Company.
10.33 Sales Agent Agreement dated May 7, 2001 between Bathgate McColley
Capital Group, LLC and the Company.
21.1 Amended Subsidiaries of the Registrant (filed as Exhibit 21.1 to the
Company's Registration Statement on Form 10-SB filed June 29, 1998).
- ----------------------------------------
(b) Reports on Form 8-K.
None
SIGNATURES
In accordance with the requirements of the Securities Exchange Act of
1934, the registrant caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
CORGENIX MEDICAL CORPORATION
November 14, 2001 By: /s/ Luis R. Lopez
-------------------
Luis R.Lopez, M.D.
Chairman and Chief Executive Officer