Aus einem richtig guten US-Posting: By: jcrom56
21 Sep 2003, 09:42 PM EDT Msg. 14319
Mein Fazit aus dem Folgenden: Wir sind auf einem guten Weg.
Die US-Calyfans spekulieren über bis zu 20 Bucks in 5 Jahren
Viel Spaß bei der Lektüre (falls schon mal gepostet - sorry)
Smokey
Calypte Biomedical Corp (BB: CYPT)
INVESTOR PRESENTATION
July 2003
CONFIDENTIAL
COMPANY OVERVIEW
EXECUTIVE SUMMARY
Large market opportunity based on increasing government spending
Unique patent protected FDA approved solution for HIV detection
Expanding into RAPID diagnostic arena utilizing urine and blood
Calypte has completed the first year of its restart
Investment-friendly cap structure
New company management
Solid scientific team
Financially stabilized company
Focused sales strategy, with imminent contract announcements with large imminent contracts
Finalize financing
Large Return on Investment
COMPANY OVERVIEW
Calypte is the only FDA approved Urine HIV detection company and one of only two manufacturers of FDA approved Western Blot confirmation tests
Calypte?s suite of Urine-based products offer numerous cost advantages and delivery advantages over blood resulting in millions tests performed since being FDA Approved
Calypte?s scientific team has many years of senior management experience, Toby Gottfried, Chief Scientific Officer, Richard George, VP of Rapid Development and Ron Mink, Director of Rapid.
6 months away from the first Rapid IDE
Experienced Management and Board
Patent protection of key urine technology
FDA approved class 3 diagnostic manufacturing facilities
PRODUCT AND END USER REQUIREMENTS
No potential for contamination
Less skilled labor required, cheaper to collect
Documented increase in voluntary
testing
Testing is not limited by volume of
sample
Combats cultural sensitivities to blood
Multiple urine test options
Cost-effective, safe, painless
Full diagnostic algorithm 99.7% sensitivity in known HIV antibody positive subjects
100% specificity in low-risk subjects
Microwell EIA
US Life Insurance
Prisons, military
Community based organizations
funded through charitable organizations
HMOs
Government Institutional testing
VALUE PROP.
TARGET MARKET
Western Blot Urine
Western Blot Serum
Extends urine testing to confirmation
Gold standard for confirmation of blood HIV testing
1 of 2 companies who produce
Confirmation for RAPID blood tests
EIA market
Blood Bank
Red Cross
Diagnostic laboratories
Rapid Blood
No lab required
Rapid results ? 15 minutes
Fingerprick eliminates need for Phlebotomist
Point of care
International markets where prevalence of HIV is high, and lacking infrastructure
Rapid Urine
No lab required
RAPID results ? 15 minutes
Non-invasive specimen collection
FDA STATUS
August 96 ? Approved
July 98 ? Approved
Acquired 1998
12/03 IDE Application
filing
10/03 IDE Application
filing
Point of Care
Institutional Testing
PATENTS (INTELLECTUAL PROPERTY)
Patent Yrs. Remaining Region
Multi-Immunoassay Diagnostic System for Antigens and Antibodies 13 US
Antigens & Antibodies 15 Canada
12 Israel
15 Korea
8 New Zealand
Method for Producing a Recombinant
Baculovirus Expression Vector (licenses) 6 US
Method for Detecting Antibodies to Human 7 US
Immunodeficiency Virus (licensed) 17 Canada
15 Japan
14 South Korea
7 Sri Lanka
Assay for detecting infection by Human T-Cell Lymphotropic Virus III
(gp 120) (licensed) 6 US
HIV-1 Lysated Immunodiagnostic products for detection of HIV-1 antibodies 3 US
in serum (licensed)
INDUSTRY OVERVIEW
COMPANY OVERVIEW
Anthony J. Cataldo ? Executive Chairman
Chairman and Director of Senetek PLC; President of Internet Systems, Japan
Jay Oyakawa ? President and Chief Operating Officer
Pacific EyeNet, LEK Consulting, DLJ, NameSafe Inc
Richard Brounstein ? Chief Financial Officer
Certicom Corp; VidaMed, Inc.; MedaSonics, Inc.; MBA CPA
Jerry Dotson ? Director of Finance
C&H Sugar, Chlorox
Dick VanMaanen ? Director, International Sales & Marketing
ADI Diagnostics; Abbott Diagnostics; Millipore Scientific
Toby Gottfired, Ph.D. ? Chief Scientific Officer
Carninex Corporation; Hepatitis Research Lab. Of UCSF Medical Center
Richard George PhD ? Vice President of Rapid Development
Orasure Technologies, Senior Vice President for Research and Development, Epitope, Chief Scientific Officer
Ronald Mink, PhD ? Director of Rapid
Director of R&D of Orasure
Don Kafader ? Director of Regulatory
Organon Teknika; Murex Diagnostics; Wellcome Diagnostic Systems; Mallinckrodt
Jerrilyn Sturge ? Director of Clinical Affairs
Cytran; Genetic Systems
Luc Montagnier ? Company Consultant
Co-discoverer of HIV I and HIV II
Scientific Team
Management
RECENT U.S. MARKET INFORMATION
Bush signs $15 billion dollars AIDS package, increases world awareness of HIV through launching African initiative
G8 countries pledge to provide additional support
$3 billion health commitment by Bill and Melinda Gates Foundation with major emphasis on HIV
CDC launches push for RAPID HIV diagnostic tests
Growing private market support
New Governmental mandates for HIV testing in pregnant women
Proactive stance towards testing by CDC
COMPETITION
COMPETITION
Source: www.rapid-diagnostics.org
BLOOD/PLASMA
Highly Fragmented
SALIVA/ORAL
URINE
MARKET OPPORTUNITY
HIV/AIDS MARKET STATISTICS
Worldwide
40 million people are estimated to be living with HIV/AIDS
5.3 million new HIV infections annually
Since AIDS was discovered:
65 million people infected
25 million deaths making it the 4th largest cause of death globally
Global fund of $7-10 billion has been established by the UN
HIV/AIDS is expensive and has high visibility in US and Worldwide
United States
650,000 ? 900,000 people living with HIV
1 in 4 do not know they are infected
US Federal government spends $10 billion on HIV/AIDS annually
China
UN estimated 10 million infected by 2010
1 million people reportedly infected
Africa
AIDS is the #1 cause of death in Africa
28.5 million estimated to be living with HIV/AIDS in sub-Saharan Africa
India
4 million estimated to be living with HIV
RECENT FUNDING ANNOUNCEMENTS FOR COMBATING HIV INTERNATIONALLY
The Global Fund and Kenya have signed an agreement on June 18th, 2003 for $37 million in grants to fight HIV/AIDS.
Zambia receives grant for $42.6 million over two years from The Global Fund on April 3rd, 2003.
Chile receives grant from The Global Fund on June 2nd, 2003 for $13.6 million over 2 years for the acceleration of the country?s HIV/AIDS treatment and prevention programs.
Tanzania receives grant agreement from The Global Fund on July 7th 2003 worth up to $5.4 million for HIV preventive education over 5 years
CALYPTE STRATEGY
INTERNATIONAL FUNDED OPPORTUNITIES
Consumer
Retail
$10.0B
U.S.AID
$510 M (?03)
Mozambique
$5 M
Thailand
$31 M
Gates
Foundation
$3 B
World
Bank
Hundreds of $M
President?s
Office on
National AIDS
Policy
$15 B
Global Aids
Funds
$B?s from many
countries
Population
Service
International
FNIH
$400 M
Tanzania
$5.4 M
Cambodia
$60 M
Kenya
$37.0 M
Ghana
$10.0 M
Calypte Opportunities
STABILIZE COMPANY
Initial reduction in force of 9 employees resulting in $1.4 million dollars of salary cost per year with 10 more reductions in force slated for March 31st 2004
Discontinued costly community based organization channel developed by previous management
New sales strategy focusing on International EIA and IDE RAPID test opportunities
Negotiate new terms with largest lab partners (CRL, LabOne) for more favorable, long-term contracts
Restart key vendor relationships critical to RAPID initiative
Re-alignment of organizational structure, making Richard George and Ron Mink, formerly of Orasure, as leaders of Calypte?s RAPID Initiative
Close two traunches of financing: $5 million and $15 million
CONTINUE TO BUILD OUT INTERNATIONAL DISTRIBUTION AND SALES
Established Distributors
Centrum, Mexico
REM, Brazil
Teva, Israel
Otsuka, Japan
Medicure, Philippines
Sumit, India
PCL, Thailand
Unihealth, Malaysia
Imminent Distributors
Adaltis, Montreal
Enfield, Taiwan
Mistaire, GCC
Russian Distributor
Zypute, China
DeYi, China
Invitro, Greece
Nepal Distributor
South African Distributor
Biociencia, Brazil
Biomerieux, Mexico
INTELLIGENTLY PURSUE DOMESTIC OPPORTUNTIES WITH SCALE
INS Industry
Community Based Organization
Label countries appropriately
Pilot: Prison/Military
Brooke Army Medical
Lackland AFB
CONSOLIDATE MANUFACTURING PLANTS FOR EIA AND WESTERN BLOT`
Attain internationally competitive cost structure
Reduce EIA unit cost from $1.88 to $1.28, a 38% reduction on fixed cost per existing unit volume and 22% reduction in personnel costs/unit
Reduce Western Blot unit cost from $42.94 to $26.67, consisting of a $9.36 reduction in fixed costs/unit and $6.90 reduction in personnel costs/unit
Reduce Headcount by 13 representing $744k in payroll cost and 14% of total payroll
Reduce Rent by $1.1 million, representing 46% of total occupancy costs
Focus manufacturing for continuous product improvement and increased efficiency
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