Business Plan Presentation on Reference Laboratory for Pharmacogenomics Founders : Sandeep Saxena and Sunil Kumar Team : Dr Suresh Advani, Dr. Hema Ramaswamy, Dr S Jain and Neelam Chauhan

Who are we? Two batchmates from NirmaLabs having complementary skills and sufficient experience. Wanted to do something challenging, useful to society and create substantial wealth Ready to make sacrifices and take risks

Two batchmates from NirmaLabs having complementary skills and sufficient experience.

Wanted to do something challenging, useful to society and create substantial wealth

Ready to make sacrifices and take risks

Pain Points Pharmaceutical companies make block buster drugs and doctors give prescriptions assuming “one drug fits all” But 70 % patients benefit, 25 % show no response, 5 % show side effects. In USA, 20 million people need hospitalization and 100,000 people die every year due to adverse drug reactions This is because of genetic differences Pharmacogenomics is the study of genetic differences to predict drug response

Pharmaceutical companies make block buster drugs and doctors give prescriptions assuming “one drug fits all”

But 70 % patients benefit, 25 % show no response, 5 % show side effects. In USA, 20 million people need hospitalization and 100,000 people die every year due to adverse drug reactions

This is because of genetic differences

Pharmacogenomics is the study of genetic differences to predict drug response

Idea Setup a reference laboratory that collects samples for genetic tests Cancer drugs have a narrow therapeutic index, have side effects and are expensive. Value lies in identifying responders, non responders and patients who are at risk of toxicity and hence saving expenses on ICU, supportive care, antibiotics and trauma to the patient and family

Setup a reference laboratory that collects samples for genetic tests

Cancer drugs have a narrow therapeutic index, have side effects and are expensive.

Value lies in identifying responders, non responders and patients who are at risk of toxicity and hence saving expenses on ICU, supportive care, antibiotics and trauma to the patient and family

Idea Concept is multidisciplinary involving pharmacology, medicine, pathology, molecular biotech and business. Sales is through Doctors who will prescribe these tests to patients. Have Medical Representatives to build awareness across India. Right now this is a niche business and does not affect any existing player

Concept is multidisciplinary involving pharmacology, medicine, pathology, molecular biotech and business.

Sales is through Doctors who will prescribe these tests to patients. Have Medical Representatives to build awareness across India.

Right now this is a niche business and does not affect any existing player

Example : 5FU and DPD 5FU is most commonly drug used to treat solid tumors DPD enzyme is responsible for metabolizing 85 % of 5FU *2A is the most common mutation in DPD that results in a truncated protein with no activity 1% of Caucasians have *2A mutation. These patients are at high risk of fatal toxicity International literature warrants DPD testing before 5FU exposure

5FU is most commonly drug used to treat solid tumors

DPD enzyme is responsible for metabolizing 85 % of 5FU

*2A is the most common mutation in DPD that results in a truncated protein with no activity

1% of Caucasians have *2A mutation. These patients are at high risk of fatal toxicity

International literature warrants DPD testing before 5FU exposure

Example : 5FU and DPD But in India, about 5 % Indian patients treated with 5FU show severe side effects One study on Indian Population on 13 individuals in US, found 1 person carrying *2A From 25 normal individuals, we found 2 carrying *2A mutation. We are Indian Oncologists are aware of DPD deficiency

But in India, about 5 % Indian patients treated with 5FU show severe side effects

One study on Indian Population on 13 individuals in US, found 1 person carrying *2A

From 25 normal individuals, we found 2 carrying *2A mutation. We are

Indian Oncologists are aware of DPD deficiency

Market Size : Cancer Patients Compiled from various sources 50 UGT1A1 Irinotecan 500 MTHFR Methotrexate 700 NAT, GST, MDR1 CYP Various Cancer Drugs 100 ECC1 Cisplatin 300 TS 5FU 300 DPD 5FU 8 TPMT 6MP # of Patients (in ‘000) Gene Drug

Market Size: Other diseases Compiled from various sources 50 Surgery and Transplants 50 CNS 50 AIDS 10 TB 20 Asthma 50 Diabetes 50 Cardio Vascular 20 Cancer # of Patients (in Lacs) Description

Market Size Every Individual has 38,000 genes and every one would a genetic test for one reason or another over the next 5 years Hence this is a great opportunity, with great growth potential

Every Individual has 38,000 genes and every one would a genetic test for one reason or another over the next 5 years

Hence this is a great opportunity, with great growth potential

Acton Biotech Pvt. Ltd.

Startup Started on 15 th Feb, 2006 Did extensive research Hired Neelam as first employee and partnered with PERD center for equipment and space Indigenously developed tests Handled logistics Met 100 oncologists across India Received 24 paid samples and 66 samples for research for TPMT Genotyping Spent Rs 7,00,000, Revenue of Rs 30,000

Started on 15 th Feb, 2006

Did extensive research

Hired Neelam as first employee and partnered with PERD center for equipment and space

Indigenously developed tests

Handled logistics

Met 100 oncologists across India

Received 24 paid samples and 66 samples for research for TPMT Genotyping

Spent Rs 7,00,000, Revenue of Rs 30,000

Immediate Plan Sunil focus on Mumbai Collect samples for DPD Genotyping Launch MTHFR Genotyping by 15 th Jan Complete company registration formalities CME in Mumbai and Delhi by Feb end Indirect marketing activities like website, email, charitable organization, Insurance, defense and corporate medical schemes

Sunil focus on Mumbai

Collect samples for DPD Genotyping

Launch MTHFR Genotyping by 15 th Jan

Complete company registration formalities

CME in Mumbai and Delhi by Feb end

Indirect marketing activities like website, email, charitable organization, Insurance, defense and corporate medical schemes

Next Step Setup the Laboratory in Vadodara Hire scientists, technicians and office staff Hire Medical Representatives for Delhi and Bangalore Get additional business from CROs and International market

Setup the Laboratory in Vadodara

Hire scientists, technicians and office staff

Hire Medical Representatives for Delhi and Bangalore

Get additional business from CROs and International market

Vision and Mission Be the leader in pharmacogenomic testing offering cutting edge, cost effective and accurate tests Build an organization that is lean and knowledge intensive, offers conducive environment to learn and grow Maintain clean and ethical operations

Be the leader in pharmacogenomic testing offering cutting edge, cost effective and accurate tests

Build an organization that is lean and knowledge intensive, offers conducive environment to learn and grow

Maintain clean and ethical operations

Key Success Factors Quality Laboratory Aggressive expansion of test menu and reach in important markets Building a strong brand to state that we are strong in technology, cost effective and the first bring these these tests to India. Having a cohesive team of scientists, technicians, Medical Representatives Low cost operations

Quality Laboratory

Aggressive expansion of test menu and reach in important markets

Building a strong brand to state that we are strong in technology, cost effective and the first bring these these tests to India.

Having a cohesive team of scientists, technicians, Medical Representatives

Low cost operations

Team Sandeep Saxena, BSc Life Science and MBA Finance with 8 years of professional experience. Sunil Kumar, BA (University Topper), MBA (Marketing) Dr. Suresh Advani. 25 years in Tata Memorial Hospital of which last 10 years as Head of Medical Oncology. Leading Oncologists of India. Dr. Hema Ramaswamy, More than 20 years of biotech research in US and India Ms. Neelam Chauhan (Ph D in Pharmacogenomics from PERD center, Ahmedabad) Dr. Shwetank Jain, General Practitioner in Mumbai and with investments in Real Estate

Sandeep Saxena, BSc Life Science and MBA Finance with 8 years of professional experience.

Sunil Kumar, BA (University Topper), MBA (Marketing)

Dr. Suresh Advani. 25 years in Tata Memorial Hospital of which last 10 years as Head of Medical Oncology. Leading Oncologists of India.

Dr. Hema Ramaswamy, More than 20 years of biotech research in US and India

Ms. Neelam Chauhan (Ph D in Pharmacogenomics from PERD center, Ahmedabad)

Dr. Shwetank Jain, General Practitioner in Mumbai and with investments in Real Estate

Advisors Business and Strategy Dr. Madhu Mehta, NirmaLabs, Ahmedabad Mr. Thyagrajan, NirmaLabs , Ahmedabad Biotech Dr. B J Rao, TIFR, Mumbai Dr. Anand Kumar, ABLE, Bangalore Diagnostics Dr. Abha Shroff, Disha Pathology, Mumbai Dr. Toprani, Toprani Laboratory, Vadodara Dr. Shabazkar, Shabazkar Lab, Mumbai Pharmacogenomics Dr. G S Bhattacharya, AMRI, Kolkatta Dr. Somasundaram Kumaravel, IISc, Bangalore Dr. K Satyamoorthy , MAHE, Manipal

Business and Strategy

Dr. Madhu Mehta, NirmaLabs, Ahmedabad

Mr. Thyagrajan, NirmaLabs , Ahmedabad

Biotech

Dr. B J Rao, TIFR, Mumbai

Dr. Anand Kumar, ABLE, Bangalore

Diagnostics

Dr. Abha Shroff, Disha Pathology, Mumbai

Dr. Toprani, Toprani Laboratory, Vadodara

Dr. Shabazkar, Shabazkar Lab, Mumbai

Pharmacogenomics

Dr. G S Bhattacharya, AMRI, Kolkatta

Dr. Somasundaram Kumaravel, IISc, Bangalore

Dr. K Satyamoorthy , MAHE, Manipal

Medical Advisors Ahmedabad Dr Shirish Alulkar, Cancer Care Clinic Dr. Chirag Desai, Vedanta Mumbai Dr. Bharat Agarwal, Wadia Children Hospital Dr. Asha Kapadia, Hinduja Hospital New Delhi Dr. Gauri Kapoor, Rajiv Gandhi Cancer, New Delhi Dr. Meenu Walia, Dharmashila Cancer Hyderabad Dr. Dattatreya, Indo American Cancer, Hyderabad Pune Dr Shailesh Kanvinde, DM Hospital, Pune Bangalore Dr. Udai Kumar Maiya, Bangalore Hospital

Ahmedabad

Dr Shirish Alulkar, Cancer Care Clinic

Dr. Chirag Desai, Vedanta

Mumbai

Dr. Bharat Agarwal, Wadia Children Hospital

Dr. Asha Kapadia, Hinduja Hospital

New Delhi

Dr. Gauri Kapoor, Rajiv Gandhi Cancer, New Delhi

Dr. Meenu Walia, Dharmashila Cancer

Hyderabad

Dr. Dattatreya, Indo American Cancer, Hyderabad

Pune

Dr Shailesh Kanvinde, DM Hospital, Pune

Bangalore

Dr. Udai Kumar Maiya, Bangalore Hospital

Competition Large reference labs like Dr. Lal Path lab, SRL Ranbaxy, Well Spring, Thyrocare, Metropolis, Vimta Lab and Reliance Life Sciences Small technology players like Genome Biotech, Synchron and Triesta Hospitals like Gangaram, Hinduja and Manipal International players like Mayo Clinic, Labcorp, Myraid, DxS, deCODE Genetics, Genentech, Gentris, Genedia, Golden Helix, Specialty Laboratory, Prometheus Laboratory, Biologix Research Corporation, Oncoscreen, Geneblitz Academic centers like CCMB, MAHE, Actrac

Large reference labs like Dr. Lal Path lab, SRL Ranbaxy, Well Spring, Thyrocare, Metropolis, Vimta Lab and Reliance Life Sciences

Small technology players like Genome Biotech, Synchron and Triesta

Hospitals like Gangaram, Hinduja and Manipal

International players like Mayo Clinic, Labcorp, Myraid, DxS, deCODE Genetics, Genentech, Gentris, Genedia, Golden Helix, Specialty Laboratory, Prometheus Laboratory, Biologix Research Corporation, Oncoscreen, Geneblitz

Academic centers like CCMB, MAHE, Actrac

Risk Technology is new and unproven Indian population genetic data is limited Market is nascent and might take more time than expected to develop Equipment is expensive is becomes obsolete very fast Experienced people are scarce Large players with financial muscle and unethical practices might enter We might have a small % of false positive and false negatives and this is because of other genetic and environmental factors.

Technology is new and unproven

Indian population genetic data is limited

Market is nascent and might take more time than expected to develop

Equipment is expensive is becomes obsolete very fast

Experienced people are scarce

Large players with financial muscle and unethical practices might enter

We might have a small % of false positive and false negatives and this is because of other genetic and environmental factors.

Finance

Break Even Point Monthly Expenses : Rs. 1,00,000 Unit Price : Rs 3000 Variable Cost : Rs 500 Gross Profit : Rs 2500 Break Even Point : 40 Samples Expected in Feb, 2007

Monthly Expenses : Rs. 1,00,000

Unit Price : Rs 3000

Variable Cost : Rs 500

Gross Profit : Rs 2500

Break Even Point : 40 Samples

Expected in Feb, 2007

Cash Flow

Investments Required Immediate Laboratory Setup : Rs 20 Lacs Working Capital : Rs 20 Lacs Differed (6 months) Sequencer : Rs 40 Lacs Buffer : Rs 20 Lacs

Immediate

Laboratory Setup : Rs 20 Lacs

Working Capital : Rs 20 Lacs

Differed (6 months)

Sequencer : Rs 40 Lacs

Buffer : Rs 20 Lacs

Further Reading FDA guidelines for Pharmacogenomics data submission Drugs don’t work by Allen Roses, GSK Few Scientific Papers Brochure and MR Presentation for TPMT and DPD Certification from ROC, Gujarat for Allotment of Name Sample Report Incubation agreement with NirmaLabs MOU with Dr Advani, Dr. B J Rao, NirmaLabs Sandeep and Sunil Letter to Dr. Shwetank Jain for Investment.

FDA guidelines for Pharmacogenomics data submission

Drugs don’t work by Allen Roses, GSK

Few Scientific Papers

Brochure and MR Presentation for TPMT and DPD

Certification from ROC, Gujarat for Allotment of Name

Sample Report

Incubation agreement with NirmaLabs

MOU with Dr Advani, Dr. B J Rao, NirmaLabs Sandeep and Sunil

Letter to Dr. Shwetank Jain for Investment.