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ImmunoCount (IC)
March 2009
Confidential please do not distribute without prior permission.
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Highlights
Suffering
Gap
Innovation
Leadership
Revenue
Company
33 million People are Living With HIV/AIDS (PLWHA)
Lack of low cost, simplified CD4/CD8 testing solutions
IC is filling the gap and has been approved by the Indian CentralDrugs Control Administration (CDSCO) (FDA equivalent). 4 more products are ready for CDSCO approval and patent process.
Strong management team with relevant healthcare , researchand business experience.
Purchase approved in India and Zambia.
Founded in 1997 with focus on developing simplified tests forunderserved markets
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Background
Estimated 33 million PLWH and 8 million with AIDS
PLWHA should be tested 2 to 3 times = minimum 66 million tests annually
70% of 33 million PLWHA are in developing countries
70% of PLWHA in developing countries are not properly tested, ICs market
Only 31% of people who needed HIV treatment had access to it by end-2007.
Once the CD4 count reaches below 200, Antiretroviral Therapy (ART) forPLWHA is paid by the UN
This is a major motivation for PLWHA to be tested regularly
Source (WHO)
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IC Solution
IC test measure CD4/CD8 cell count for PLWHA to monitor theprogression of the disease
IC is a low cost solution and easy to use product geared towards servingrural areas in the developing world
IC is approved by CDSCO and has a patent
CDSCO approval permits IC to market in Africa and Asia
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Solving the pain
Readily availableLowHighTechnician skill
LowHighMaintenance
CleanSterileEnvironment
Less training requiredLow skilledtechnician toneeded to manage
the process
High skilledtechnician requiredto operate the
machine
Process
Portable and able toreach the masses
Ideal for peri-urban& rural areas withlow testing volume
Suitable forurban area with hightesting volume
Benefit
Price competitive$10$15 to $25Selling price/test
Only a microscope needed$400$50,000+Capital expense
IC advantageImmunoCountFlow Cytometer
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Universal Access 2010
Funding Sources:
World Bank, WHO, Global AIDS Fund, Gates Foundation, ClintonFoundation, and many others
At the end of 2007, the gap between required and available funding was
estimated to be US$ 8.1 billion. To meet universal access targets,funding will have to more than quadruple to US$ 35 billion in 2010 andto US$ 41 billion in 2015. (Source: WHO)
Simplified and low cost solutions, such as ImmunoCount will be neededto serve the masses and reach the rural areas
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Product Testing & Validation
India: Third party has successfully evaluated and approved IC tests for India NACO has authorized purchase of 100,000 tests
Zambia: University of Lusaka Teaching Hospital (UTH) has evaluated and approved the
product to the Ministry of Health Zambia team has introduced the product and received positive response from
Congo, Mozambique, and Angola
Following is the conclusion from UTH report:
The IC is the best new technology for peri-urban and rural areas of Zambia withlow cost.
South Africa: Nelson R. Mandela School of Medicine has approved the field evaluation process
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Management
Dr. Subhash HiraFounder & Chairman
Harish MamtaniPresident & CEO
Rajni Shivani, PhDTechnical Director
Dr. Vishwas Sarangdhar
BiotechnologyConsultant
Dr. Hira has been involved in HIV/AIDS field since 1980with primary focus on Africa and Asia. Dr. Hira is theWorld Bank Program Leader for HIV/AIDS in India.
Investment management background. Actively invests inpublic and private markets.
Responsible for QA and managing the productionprocess.
Has played an active role in new technology and productdevelopment. Previously worked with Reliance LifeSciences .
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Post Funding Next 12 Months
$2 million funding allows IC to achieve the following tasks
3 months: Secure real estate for R&D lab and manufacturing facilities in India Close contract with India or Zambia for 200,000 IC tests
6 months: Begin delivering product to NACO, Zambia, and others in phases over the next 6 months.
Close contract for additional 200,000 tests Apply for WHO pre-qualification so third party evaluation is not required at each country level Complete development of rapid CD4 test kit (new technology) Submit 4 products for CDSCO approval (6 month process)
9 months: Complete product development for 4 more R&D products for a total of 9 products
12 months: Have infrastructure in place to penetrate top 10 markets Complete facilities to meet the higher production needs
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Product Pipeline
IC
Viral Load HIV I
Viral Load HIV II
TB (PCR)
TB (MODS)
Stage Patent CDSCO
Approval
Launch
Produce Granted (India) Yes 6 months postfunding
Clinical trial
Apply Post
funding
Projected 6
months post
funding
18 months post
patent
application
Clinical trial
Apply Post
funding
Projected 6
months post
funding
18 months post
patent
application
Clinical trial
Apply Post
funding
Projected 6months post
funding
18 months postpatent
application
Clinical trial
Apply Post
funding
Projected 6
months post
funding
18 months post
patent
application
Applying core competencies to develop simplified testing solutions
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Opportunity
Significant market The burden of infectious diseases is high in developing countries.
Low financial and technical resources to meet the widespread need in rural areas
Relationships The Companys founders and directors are well-known to product buyers in Africa, Asia, and
Latin America
Practical solution The lack of cost effective competitive products is an advantage Current products offerings require high technical talent and are expensive to reach the rural
areas in developing world
Market need The company is well positioned to fulfill the desperate market need with proper attention
and focus Desperate need by world agencies for low cost solutions
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Appendix
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Management
Dr. Subhash Hira is a medical doctor who specialized in Infectious Diseases and
Public Health from Baroda, UK and the US. He has had a distinguished career of 30
years during which he has held senior positions with the Zambian Ministry ofHealth, Uniformed Services University, Bethesda; the University of Texas-Houston;The World Bank, Washington DC; The World Health Organization; and UNICEFamong a host of UN and multi-lateral agencies. Dr. Hira has the cross-culturalexperience of living and working in challenging environments. For most of his career
he has been involved with HIV/AIDS, tuberculosis and other Infectious Diseasesand has several firsts to his credit, from published evidence in 1982 that HIV washeterosexually transmitted among Africans, to starting ART in India in 1996. He hasover 100 scientific publications in international journal and has contributedchapters in international medical text books.
Presently, Dr. Hira is consulting with the World Bank and the Global Fund on healthprograms.
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Management
Mr. Harish Mamtani is the Managing Director of Bluefish Capital, LLC. Mr. Mamtani launchedthe firm in July 2005 to offer independent and objective advice to family offices and high networth clients on their global portfolios. In his role, Mr. Mamtani created diversified portfolioscomprising of liquid instruments, hedge funds (direct and fund of funds), global private equity,and real estate. In addition, Mr. Mamtani managed direct investments for his clients in thetechnology, healthcare, and real estate sectors.
In January 2009, Mr. Mamtani joined IC as its CEO.
Prior to Bluefish Capital, LLC, Mr. Mamtani co-managed a team at Bank of America Private
Bank where they advised bank clients on investments. Mr. Mamtanis team managed $960million for banks clients. Mr. Mamtani began his career in wealth management in 1998 withMerrill Lynch and subsequently his entire team moved to Morgan Stanley.
Mr. Mamtani began his professional career with Price Waterhouse as a Management Consultant.Mr. Mamtani worked with sophisticated software packages such as SAP, PeopleSoft, and Oracle
in fields of EDI, Finance, and Human Resources.
Mr. Mamtani has a BA in Accounting and Master of International Business Studies (MIBS) fromthe University of South Carolina.
Mr. Mamtani served as 2007 President for TiE Atlanta and has been a Charter Member since
2005. From 2002 to 2006, Mr. Mamtani was the President of the Atlanta High Tech CEOCouncil in Atlanta, GA.
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Adults and Children living with HIV worldwide
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Market Conditions
June 2005 Between 2001 and 2005, the number of people on antiretroviral therapy (ART)
in low and middle-income countries increased more than fivefold
From 240,000 to approximately 1.3 million (Figure 7.1 next page)
21 countries were providing ART to 50% of those in clinical need (WHO andUNAIDS, 2005)
In Africa, the number of people on ART more than doubled in 2005 alone
Only one in six people who needed treatment received ART by December2005
Nearly 200 sites in Kenya were providing ART by December 2005
In South Africathe country with the largest population of people living withHIVthe number of people receiving ART grew from fewer than 5,000 at thebeginning of 2004 to roughly 190,000 by the end of 2005
2007
There are approximately 3 million people on ART
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PLWHA receiving therapy
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Global Funding
Financing AIDS globally Resource requirements in 2007 are estimated to be US$ 18.1 billion, while
resources expected to be available for the same year are estimated at US$10 billion. This highlights the need for cost effective offerings.
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Product Pipeline
TB Monitoring product 2 TB products
TB PCR TB MODS
Patent application to begin in upon funding
CDSCO approval submission to begin upon funding
Tuberculosis There are 9 million new cases of TB each year.
One-third of new TB cases occur in Southeast Asia
Estimated incidence per capita is highest in sub-Saharan Africa Highest number of estimated deaths due to TB and the highest mortality
per capita are in Africa, where HIV has led to rapid increases in TBincidence. Source: World Health Organization (WHO).
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ImmediateTarget Market
South Africa
India
Mozambique
Zimbabwe
Tanzania
Kenya
Zambia
Uganda
Congo
Countries marked in bluerepresent IC activity
Countries marked in redrepresent target market
Country HIV Cases
South Africa 5,500,000
India 2,500,000Mozambique 1,800,000
Zimbabwe 1,700,000
Tanzania 1,400,000
Kenya 1,300,000
Zambia 1,100,000
Uganda 1,000,000Congo 1,000,000
Russian 940,000
Ethiopia 750,000
Cte d`Ivoire 750,000
China 650,000
Brazil 620,000
Thailand 580,000
Cameroon 510,000
Myanmar 360,000
Angola 320,000
Ghana 320,000
Vietnam 260,000
Central African Republic 250,000Namibia 230,000
Swaziland 220,000
Rwanda 190,000
Haiti 190,000
Mexico 180,000
Cambodia 130,000Total 24,750,000
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Process
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Use of Proceeds
IC will be launched with $2 million funding and will seek to fund otherproduct initiatives from internal cash flow and grants.
$5 million is required for fully funded plan for all current and futureproducts (needs subject to change depending on final relationships
established for outsourcing)
$1,000,000 to establish new facilities in India
$1,000,000 to complete the is patent and CDSCO approval process
for 4 products that have been clinically tested $1,000,000 R&D for new products
$1,000,000 to launch sales and marketing initiatives
$1,000,000 working capital