SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report: June 25, 2001
Corgenix Medical Corporation
(Exact Name of registrant as specified in its charter)
Colorado 000-24541 93-1223466
(State or other Commission File I.R.S. Employer
jurisdiction of Number) Identification No.)
incorporation)
12061 Tejon St.
Westminster, Colorado 80234
(Address, including zip code, of principal executive offices)
(303) 457-4345
(Registrant's telephone number including area code)
Item 7. Financial Statements and Exhibits
(c) Exhibits.
No. Description
99.1 Investor, broker and analyst presentation materials of the President
and Chief Financial Officer of Corgenix Medical Corporation used on
June 26, 2001 and to be used from time to time thereafter.
Item 9. Regulation FD Disclosure
On June 26, 2001, Corgenix Medical Corporation management met with
investors, brokers and analysts in the first of a series of meetings. A copy of
the presentation materials of the company's President and Chief Financial
Officer that were used at that meeting and which are to be used from time to
time thereafter is filed as Exhibit 99.1 hereto.
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
DATED, this 25th day of June, 2001.
Corgenix Medical Corporation
By: /s/ Douglass T. Simpson
-------------------------
Douglass T. Simpson
President
Slide 1:
Corgenix Medical Corporation
Safe Harbor Statement
Forward Looking Disclaimer--This presentation includes forward-looking
statements and projections that involve a number of assumptions, risks and
uncertainties. Actual results and projections may vary significantly from the
Company's expectations based on a number of factors, including (1) Corgenix's
dependence on collaborative relationships and third parties for product
development and commercialization (2) market acceptance of new products and
services introduced by the Company (3) competition in the diagnostics industry,
(4) Corgenix's dependence on distribution partners for sales of its diagnostics
products in international markets (5) continuing technology changes in the
diagnostics industry that may affect both Corgenix and its customers, (6)
continuing demand for Corgenix's products (7) Corgenix's ability to accurately
predict its costs related to new products, and (8) additional factors described
in Corgenix's most recent Forms 10-K and 10-Q.
Slide 2:
Corgenix Medical Corporation
Corgenix, Inc. develops, manufactures and markets unique and innovative
diagnostic (immunoassay) tests for chronic and acute human diseases and
disorders to the worldwide healthcare market.
Slide 3:
Immunoassay (ELISA)
- -Detection of Antigens
- -Detection of Antibodies
- -Corgenix Technology
-Improved coating and stability of large and complex antigen -Longer shelf
life -More accurate and precise -Better specificity and sensitivity
-Faster turnaround, easy protocol
Slide 4:
The Market Opportunity
- -Worldwide Medical-Diagnostics Market Exceeds $22 Million Annually
- -Overall Market is Growing Less Than 5% Per Year
-Our Segment is Growing at 15% Per Year
-Corgenix is Growth at 20-25% Per Year
- -Market Potential for Selected Products in Point-of-Care, Over-the-Counter and
Physician-Office-Laboratory Segments is Huge and Growing Much Faster than
Conventional-Clinical-Laboratory Segment -Significant Growth Potential for Early
and Accurate Diagnosis for Autoimmune Disease, Bone and Joint Disease and
Cardiovascular Disease
Slide 5:
Other Key Market Characteristics
- -Significant Recent Market Consolidation -Majority of Market Distributed Among
Handful of Players -Competition Still Remains Highly Fragmented -Smaller Niche
Players Predominate -Increasing Pressure to Lower Medical Product Costs
- -Trending Towards Outsourcing of Costly Clinical Diagnostics to Less Expensive
OTC Markets
- -Cost Containment Creating Vertical/Horizontal Consolidation Opportunities
Slide 6:
Current Products and Applications
Diagnostic Product Diagnostic Application
- -----------------------------------------------------------------
- -----------------------------------------------------------------
Bone/Joint Disease Arthritis
Vascular Disease Bleeding and Clotting
Immunology Autoimmune Disease
Others Liver Disease, Infectious
Disease
Slide 7:
Corgenix Products in Pipeline
- -Additional Unique Products for Immunology and Vascular Disease Markets
- -Core Technology Adapted to Proprietary Platform Instrumentation With
Strategic Partner
- -Expansion of Products in Distribution Network From Other Manufacturers
Slide 8:
Hyaluronic Acid (HA) Diagnostic Test
- -Potential Break-Through Product
- -Worldwide Rights to Manufacture and Market
- -$40-50 Million Market in Liver, Arthritis and Potentially Other Significant
Applications
- -Very Sensitive Marker for Liver Damage (e.g. Hepatitis C, Cirrhosis, etc.)
- -Safer, Far Less Costly Than Liver Biopsies
- -Large Potential Market with Pharmaceutical Companies for New Drug Safety
Trials
Slide 9:
Competition and Barriers to Entry
- -Few Firms Focusing on this Niche
- -Patented Technology and "Know-How"
- -Large Multinational Commercial Partners
- -Established Worldwide Diagnostics Distribution Network
- -Rapidly Accelerating Company Critical Mass
Slide 10:
How Product Gets to Market (Average Time Frame)
1st Month: Feasibility
1st-9th Month: Design Input/Output
9th-13th Month: Verification/Validation (Clinical Trials)
11th-13th Month: FDA Submission of 510K
11th-13th Month: Investigational Use and Evaluation
13th-14th Month: FDA Approval/Begin Marketing
Slide 11:
Corgenix Historical Financials (consolidated)
Condensed results of operations (000):
Nine Months Nine Months Year Ended
Ended Ended 6/30/2000
3/31/2001 3/31/2000 (Audited)
(Unaudited) (Unaudited)
- -----------------------------------------------------------------
- -----------------------------------------------------------------
Sales $3,064 $2,566 $3,545
Gross Profit $1,967 $1,552 $2,072
GP% 64.2% 60.5% 58.4%
Operating Expenses $1,454 $1,403 $1,723
Operating Income $513 $149 $349
(Loss)
Net Income $402 $43 $200
Net Income Per Share $.02 - $.01
Weighted Average
Shares Outstanding 17,948,414* 17,170,836* 17,230,707*
The Company continues to be on track for a record year in both revenues and
earnings, and the Company is positioned to maintain this trend in the next
fiscal year as well.
*Pre Reverse Stock Split
Slide 12:
Balance Sheet Information
Numbers in thousands:
As of March 31, As of June 30, 2000
2001 (Audited)
(Unaudited)
- -----------------------------------------------------------------
- -----------------------------------------------------------------
Cash $273 $47
Working Capital $149 ($333)
(deficit)
Stockholders' Equity $739 ($43)
(deficit)
Debt to Equity Ratio .9 to 1 In Excess of 7 to 1
Slide 13:
Total Sales 12 Year Trend
Depicting upward trend in sales from 1989 to 2001.
Slide 14:
Corgenix History
- -Founded in 1990
- -Fully Reporting Publicly-Held Company Since 1998
- -Increasing Stream of Strategic Partners
- -Expanding Relationships With Chugai Pharmaceuticals and Others
Slide 15:
Management
- -Luis R. Lopez, MD, Chairman and CEO
Published clinical scientist and physician
- -Doug Simpson, President and COO
Farmitalia Carlo Erba, Sanofi Pasteur
- -Bill Critchfield, VP Chief Financial Officer
U.S. Medical, Cell Technology, Biostar, Nuclear Pharmacy
- -Ann Steinbarger, VP Sales and Marketing
Roche-Boehringer Mannheim
- -Catherine Fink, PhD, VP and General Manager
Trinity Biotech, Biosyn, DDx
- -George Fleming PhD, VP International
Brook Bond, Unilever
- -Taryn Reynolds, VP Technology
Brinker International
Slide 16:
Experts
- -Auditors - KPMG Peat Marwick
- -SEC Counsel - Davis Graham & Stubbs
- -General Counsel - Hutchinson Black and Cook
- -Commercial Bank - Vectra Bank
- -Investment Banker - Bath McColley Capital Group
Slide 17:
Executive Ratings of Device Industry Business Climate, 1993-2001
Percentage
Year reporting climate Percentage
as excellent and reporting climate
good as poor
- -----------------------------------------------------------------
- -----------------------------------------------------------------
1993 56% 12%
1994 36% 15%
1995 37% 23%
1996 47% 12%
1997 58% 11%
1998 57% 6%
1999 60% 6%
2000 64% 6%
2001 60% 3%
Slide 18:
Corgenix's Strategic Path
- -Expand Into More High-Growth Market Areas
-Bone Disease
-Infectious Disease
-Vascular Disease
- -Partner With Larger Companies to Exploit Unique Position and Technology
- -Add Profitable Contract Development, Manufacturing and Distribution
Relationships
- -Expand Distribution Worldwide
- -Expand Product Base Through Intensified R&D and Acquisitions
Slide 19:
Relative market capitalization compared with other diagnostic companies (as of
12/31/00).
Slide 20:
Summary
- -Highly Experienced Healthcare Operating Team -Large, Expanding Market
- -Recognized Niche Leader Worldwide -New Products to Market -Exceptionally
Promising Product Pipeline -Patented Manufacturing Process -Significant
Partnerships and Strategic Alliances -New Ancillary Consumer Product Strategy
- -Continuing on Track for a Record Year for the Company in Both Revenues and
Earnings and the Company is positioned to maintain this trend in the next fiscal
year.