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Life Science Investment Strategies for India:
      Translating Potential into Reality

            Harshawardhan Bal, PhD
                Stem Cell Capital
               www.stemcellcapital.com



                                                1
Unveiling India and Its Potential
Agenda
•   About Stem Cell Capital
•   Introduction to the Panel
•   The India story so far…
•   Investment strategies for India
•   Q&A


                                      2
Moderator
Harshawardhan Bal – Stem Cell Capital (US/India)
•   Lead the Life Sciences practice at Stem Cell Capital, a mid-market advisory firm
    founded in 2008 with a focus on cross-border transactions covering M&A, capital raise
    (VC/PE syndication), licensing, asset valuation, global BD and strategic sourcing.
•   Over a decade of global and diversified experience in life sciences from Dana-
    Farber/Harvard Cancer Center, OSI Pharmaceuticals and Millennium Pharmaceuticals
    / Takeda with a focus on early stage drug discovery, disease biology of HIV/AIDS and
    HTLV-induced Adult T-Cell Leukemia.
•   Consultant at Booz, Allen & Hamilton with leadership roles in NCI’s cancer Biomedical
    Informatics Grid Program and global regulatory submission harmonization strategy for
    pharma clients. Previously as VP and Head of Life Sciences for MAPE Advisory
    Group, Mumbai, was responsible for M&A and PE transactions.
•   M.S. in Pharmaceutical Sc. from Nagpur University and PhD in Molecular Biology from
    the National Institute of Immunology, New Delhi. Postdoctoral training at Univ of
    Rochester and Cold Spring Harbor Laboratory.

                                                                                            3
Introduction to the Panel
Pooja Pathak - Oxford Bioscience Partners (Boston)

•   Pooja is a Principal at Oxford and focuses on investments across life science
    sectors including therapeutics, medical devices, diagnostics and bioenergy.
    She has been involved in the investment and monitoring of portfolio
    companies such as Claros Diagnostics (point-of-care diagnostic), SmartPill (GI
    capsule technology) and Luca Technologies (natural gas production
    technology).

•   She is currently a Board Observer with Molecular Biometrics (in vitro
    fertilization diagnostic) and follows Oxford’s public positions in Acadia
    Pharmaceuticals and Antisoma.

•   Prior to Oxford, Pooja was a Senior Associate Consultant at Bain & Company,
    a global strategy consulting firm. Pooja has a BS in Chemical Engineering
    from the University of Illinois at Chicago and a MS in Chemical Engineering
    from the MIT.


                                                                                     4
Introduction to the Panel
Srini Akkaraju - New Leaf Venture Partners (Menlo Park)

•   Srini is a Managing Director at NLVP and focuses on biopharmaceuticals
    investments. Prior to joining New Leaf, Srini was a co-founder and Managing
    Director at Panorama Capital. Before forming Panorama, Srini served as
    Partner of J.P. Morgan Partners, where he was responsible for leading venture
    investing in biotech companies. Earlier, Srini held business and corporate
    development positions at Genentech where he was responsible for worldwide
    partnering activities, in-licensing of therapeutics and out-licensing of
    development projects.

•   Srini is the author of a number of peer-reviewed articles, including ones
    published in Science and Nature. Board Seats: Presidio Pharmaceuticals,
    Synageva BioPharma.

•   He received B.A. degrees in both Biochemistry and Computer Science from
    Rice University and M.D. and Ph.D. degrees in Immunology from Stanford
    University School of Medicine.

                                                                                    5
Introduction to the Panel
Yatin Mundkur – Artiman Ventures (Palo Alto)

•   Yatin is a Partner at Artiman where he focuses on early-stage Technology and
    Medtech investments. Yatin has over 17 years of experience working with
    technology companies in venture capital.
•   Previously, Yatin was Managing Director at TeleSoft Partners, where he led
    investments in over twenty companies in the early stage semiconductor and
    software sectors. He founded and served as President of Equator
    Technologies, a developer of Programmable MediaProcessors. His prior
    experience also includes senior positions at Conexant, Sun Microsystems,
    and others. He holds ten patents in areas of computer architectures, digital
    consumer electronics, semiconductor design, and software.
•   Yatin is currently on the boards of BioImagene, Cellworks Group, Infinite Z,
    Pricelock, Virident Systems and Prysm.
•   Yatin holds a B.S.E.E. from MSU of Baroda, India, and a M.S.E.E. from the
    UTexas at Austin.


                                                                                   6
Introduction to the Panel
Viren Mahurkar – Wockhardt (Mumbai)
•   Viren is Senior VP of Global BD at Wockhardt and has global responsibility for
    acquisitions, licensing and partnerships with a focus pharma, biotech &
    medical technologies including biosimilars and raising funding for the
    company’s infectious diseases preclinical/post-IND research assets.
•   Earlier he worked at Pfizer, as Director, International BD at NY, with focus on
    new growth opportunities for the Europe Region. He was responsible for
    forging European co-promotion partnerships with Novartis for cardiovascular
    combination product. He also served as Country Director of Strategy and BD
    coordinating Pfizer's efforts to define a new India growth strategy.

•   Viren specializes in M&A/investment banking and global markets and has held
    leadership positions in banking and has led some prestigious Indian deals,
    such as the acquisition and tender offer for Abbott India by Pharmacia.
•   Viren holds an MBA from the University of Delhi, MSc from the London School
    of Economics.
                                                                                      7
Unveiling India

                 The story so far…




All data taken from company, industry, trade organization and analyst reports.
                                                                                 8
India
Economic Outlook

•   4th largest economy by purchasing power parity (PPP) with a GDP of
    US$1.23 trillion
•   Ave. GDP growth of ~9% between 2005-2008
•   World’s 2nd fastest growing economy with current GDP growth at ~ 6-7%
    (2008-09) post global slowdown
•   Economic indicators project 8% growth in 2010-11 and beyond




                                                                            9
India
Pharmaceutical Industry Overview
•   4th largest in volume and 13th in value
•   >134 FDA-approved plants, one of the highest in the world
•   ~ 10,000 pharmaceutical units that produce around 400 bulk drugs and >
    60,000 formulations (covering 60 therapeutic categories)*
•   With growth ~ 8.4% YOY, India will be a top 10 global pharma market in by
    sales by 2020 with the total value reaching USD 50 Bn
•   The Dept of Pharmaceuticals, GOI founded in 2008 under the Ministry of
    Chemicals & Fertilizers aims to make India a global pharma innovation hub
    by 2020


                                                                                10
Indian Pharma Industry
Strengths…

•   Large pool of highly trained manpower
•   Well developed chemical industry and process engineering skills
•   2nd largest number of US FDA approved facilities
•   TRIPS compliance
•   Drug cost a fraction of the cost in the West
•   FDI up to 100 percent
•   Strong IT skills for research data management
•   Strong marketing and distribution network
•   Well established network of laboratories
•   Cost competitive (R&D, manufacturing, clinical trials, and labor)

                                                                        11
Indian Pharma Industry
and weaknesses…

•   Low level of investment in R&D
•   Highly fragmented industry
•   Low level of industry-academia partnerships
•   Low margins
•   Government price controls
•   Most Indian companies are small by world standards
•   Industry concentrated at lower end of value chain
•   Lack of experience in drug discovery
•   Low levels of per capita medical expenditure
                                                         12
Industry Drivers
Economic growth, population, urbanization, demographic changes and
the emergence of lifestyle diseases
•   Economic growth: The Indian economy’s recent growth expanded the middle-class
    and grew the healthcare market, a trend that is expected to continue. Increasingly
    health aware middle class with disposable income.
•   Consumer healthcare spending is expected to increase to 13% of GDP by 2015.
•   Population growth: The population is expected to grow to 1.24 Bn by 2015, while the
    aging population is expected to increase to 112 Mn, opening up a new healthcare
    dimension.
•   Middle-class growth: Households with over US$5,000 annual income are expected to
    increase to 63.8 Mn by 2015.
•   Working age and urban population prone to lifestyle diseases, as a proportion of
    overall population, is expected to increase from 28% in 2001 to around 31% by 2015.

Mindset shift of urban Indian consumers from treating illness to managing wellness       13
Generics & Services Sector Overview
    API, formulations and contract services (CRAMS)

•   India’s active pharmaceutical ingredients (API) industry with estimated sales US$4.1 Bn is the
    world’s 3rd largest after China and Italy
•   India manufactures over 400 APIs and supplies to about 50 countries; exports account for
    around 70% of sales.
•   India’s domestic formulations market is projected to grow at a CAGR of 13% to an estimated
    US$15 Bn by 2015.
•   At 30% growth YOY, CRAMS is the fast growing segment in the Indian pharma – with contract
    research contributing 29% and contract manufacturing contributing 66%.
•   Globally, the outsourcing trends are expected to grow further with the contract manufacturing
    market size at US$ 45 Bn (US$ 29 billion from formulations and US$ 16 Bn from APIs)
•   Contract research market size is estimated to be at ~ US$ 38 Bn (US$ 11 Bn from Drug
    Discovery and US$ 27 Bn from Clinical Research).


                                                                                                    14
Indian Pharma R&D

The beginning of innovation




                              15
Internal R&D Programs
NCE Pipelines of Indian Pharma
Company              Pre-Clinical   Phase I   Phase II   Phase III   Total
Lupin                     4           1          2          3         10
Dr. Reddy’s               4            2         3          1         10
Biocon                    4            -         1          2          7
Glenmark                  4            -         2          -          6
Ranbaxy                   8           1          1          -         10
Piramal Healthcare        2            -         3          -          5
Cadila                    -           3          1          -          4
Torrent                   5           1          -          -          6
Wockhardt                 4           1          1          -          6
Sun Pharma                3           1          -          -          4
Total                    38           10        14          6         69



                                                                             16
Discovery & commercialization deals
Date Company       Indian Partner                 Description
2010 Endo Pharma   Biocon’s subsidiary Syngene    First deal on discovery of a biological
                   International                  therapeutic entity for oncology
2009 BMS           Biocon’s subsidiary Syngene    Agreement to develop integrated drug
                   International                  discovery and development capabilities
2009 Pfizer        Aurobindo Pharma               Commercialize generic products in US and EU
2009 Pfizer        Claris Lifesciences            Commercialize off-patent drugs in the US,
                                                  Canada, Australia, New Zealand and Europe
2009 GSK           DRL                            Market DRL’s 100 branded pharmaceuticals in
                                                  emerging markets such as Africa, West Asia,
                                                  Latin America and Asia-Pacific, excluding India
2009 Novavax       Cadila Pharmaceuticals         Joint venture to develop, manufacture and
                                                  commercialize vaccines, drugs and diagnostics
2009 UCB Pharma    Alembic                        Apply Alembic's NDDS for UCB’s epilepsy drug
2008 Eli Lilly     Piramal Healthcare, Jubilant   Development of molecules from pre-clin to Ph II
                   Organosys and Suven
2007 Merck         Piramal, Orchid and Advinus    R&D collaboration for developing new drugs
                   Therapeutics

Evolution from (pure) Cost basis         Shared risk/reward      R&D innovation expertise
                                                                                               17
Acquisitions… a snapshot of recent deals
 Date   Acquirer       Target                      Description
 2010   Hospira        Orchid Chemicals and        Acquisition of beta-lactam
                       Pharmaceuticals             generics injectibles business
 2009   Perrigo        85 % stake in Vedants       Move API production from
        Company, OTC Drugs and Fine                Germany and Israel to India
        producer       Chemicals
 2008   Japan-based    Ranbaxy                     Acquisition of global generics
        Daiichi                                    business
 2008   Singapore's    Dabur pharma                Acquisition of oncology API
        Fresenius Kabi                             manufacturing capabilities
 2009   Sanofi Aventis (Merieux Alliance's 80 %    Strengthen vaccine portfolio
                       stake in) Shantha Biotech   and accelerate growth in
                                                   strategic emerging markets
 2009   Pfizer          Vetnex                     Acquisition of the animal
                                                   healthcare business


                                                                                    18
Thank You!
   Harshawardhan Bal, PhD
        Stem Cell Capital
  www.stemcellcapital.com
  Tel: +1 717 557 8247 (cell)
harsh.bal@stemcellcapital.com




                                19

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Bio2010 harsh bal

  • 1. Life Science Investment Strategies for India: Translating Potential into Reality Harshawardhan Bal, PhD Stem Cell Capital www.stemcellcapital.com 1
  • 2. Unveiling India and Its Potential Agenda • About Stem Cell Capital • Introduction to the Panel • The India story so far… • Investment strategies for India • Q&A 2
  • 3. Moderator Harshawardhan Bal – Stem Cell Capital (US/India) • Lead the Life Sciences practice at Stem Cell Capital, a mid-market advisory firm founded in 2008 with a focus on cross-border transactions covering M&A, capital raise (VC/PE syndication), licensing, asset valuation, global BD and strategic sourcing. • Over a decade of global and diversified experience in life sciences from Dana- Farber/Harvard Cancer Center, OSI Pharmaceuticals and Millennium Pharmaceuticals / Takeda with a focus on early stage drug discovery, disease biology of HIV/AIDS and HTLV-induced Adult T-Cell Leukemia. • Consultant at Booz, Allen & Hamilton with leadership roles in NCI’s cancer Biomedical Informatics Grid Program and global regulatory submission harmonization strategy for pharma clients. Previously as VP and Head of Life Sciences for MAPE Advisory Group, Mumbai, was responsible for M&A and PE transactions. • M.S. in Pharmaceutical Sc. from Nagpur University and PhD in Molecular Biology from the National Institute of Immunology, New Delhi. Postdoctoral training at Univ of Rochester and Cold Spring Harbor Laboratory. 3
  • 4. Introduction to the Panel Pooja Pathak - Oxford Bioscience Partners (Boston) • Pooja is a Principal at Oxford and focuses on investments across life science sectors including therapeutics, medical devices, diagnostics and bioenergy. She has been involved in the investment and monitoring of portfolio companies such as Claros Diagnostics (point-of-care diagnostic), SmartPill (GI capsule technology) and Luca Technologies (natural gas production technology). • She is currently a Board Observer with Molecular Biometrics (in vitro fertilization diagnostic) and follows Oxford’s public positions in Acadia Pharmaceuticals and Antisoma. • Prior to Oxford, Pooja was a Senior Associate Consultant at Bain & Company, a global strategy consulting firm. Pooja has a BS in Chemical Engineering from the University of Illinois at Chicago and a MS in Chemical Engineering from the MIT. 4
  • 5. Introduction to the Panel Srini Akkaraju - New Leaf Venture Partners (Menlo Park) • Srini is a Managing Director at NLVP and focuses on biopharmaceuticals investments. Prior to joining New Leaf, Srini was a co-founder and Managing Director at Panorama Capital. Before forming Panorama, Srini served as Partner of J.P. Morgan Partners, where he was responsible for leading venture investing in biotech companies. Earlier, Srini held business and corporate development positions at Genentech where he was responsible for worldwide partnering activities, in-licensing of therapeutics and out-licensing of development projects. • Srini is the author of a number of peer-reviewed articles, including ones published in Science and Nature. Board Seats: Presidio Pharmaceuticals, Synageva BioPharma. • He received B.A. degrees in both Biochemistry and Computer Science from Rice University and M.D. and Ph.D. degrees in Immunology from Stanford University School of Medicine. 5
  • 6. Introduction to the Panel Yatin Mundkur – Artiman Ventures (Palo Alto) • Yatin is a Partner at Artiman where he focuses on early-stage Technology and Medtech investments. Yatin has over 17 years of experience working with technology companies in venture capital. • Previously, Yatin was Managing Director at TeleSoft Partners, where he led investments in over twenty companies in the early stage semiconductor and software sectors. He founded and served as President of Equator Technologies, a developer of Programmable MediaProcessors. His prior experience also includes senior positions at Conexant, Sun Microsystems, and others. He holds ten patents in areas of computer architectures, digital consumer electronics, semiconductor design, and software. • Yatin is currently on the boards of BioImagene, Cellworks Group, Infinite Z, Pricelock, Virident Systems and Prysm. • Yatin holds a B.S.E.E. from MSU of Baroda, India, and a M.S.E.E. from the UTexas at Austin. 6
  • 7. Introduction to the Panel Viren Mahurkar – Wockhardt (Mumbai) • Viren is Senior VP of Global BD at Wockhardt and has global responsibility for acquisitions, licensing and partnerships with a focus pharma, biotech & medical technologies including biosimilars and raising funding for the company’s infectious diseases preclinical/post-IND research assets. • Earlier he worked at Pfizer, as Director, International BD at NY, with focus on new growth opportunities for the Europe Region. He was responsible for forging European co-promotion partnerships with Novartis for cardiovascular combination product. He also served as Country Director of Strategy and BD coordinating Pfizer's efforts to define a new India growth strategy. • Viren specializes in M&A/investment banking and global markets and has held leadership positions in banking and has led some prestigious Indian deals, such as the acquisition and tender offer for Abbott India by Pharmacia. • Viren holds an MBA from the University of Delhi, MSc from the London School of Economics. 7
  • 8. Unveiling India The story so far… All data taken from company, industry, trade organization and analyst reports. 8
  • 9. India Economic Outlook • 4th largest economy by purchasing power parity (PPP) with a GDP of US$1.23 trillion • Ave. GDP growth of ~9% between 2005-2008 • World’s 2nd fastest growing economy with current GDP growth at ~ 6-7% (2008-09) post global slowdown • Economic indicators project 8% growth in 2010-11 and beyond 9
  • 10. India Pharmaceutical Industry Overview • 4th largest in volume and 13th in value • >134 FDA-approved plants, one of the highest in the world • ~ 10,000 pharmaceutical units that produce around 400 bulk drugs and > 60,000 formulations (covering 60 therapeutic categories)* • With growth ~ 8.4% YOY, India will be a top 10 global pharma market in by sales by 2020 with the total value reaching USD 50 Bn • The Dept of Pharmaceuticals, GOI founded in 2008 under the Ministry of Chemicals & Fertilizers aims to make India a global pharma innovation hub by 2020 10
  • 11. Indian Pharma Industry Strengths… • Large pool of highly trained manpower • Well developed chemical industry and process engineering skills • 2nd largest number of US FDA approved facilities • TRIPS compliance • Drug cost a fraction of the cost in the West • FDI up to 100 percent • Strong IT skills for research data management • Strong marketing and distribution network • Well established network of laboratories • Cost competitive (R&D, manufacturing, clinical trials, and labor) 11
  • 12. Indian Pharma Industry and weaknesses… • Low level of investment in R&D • Highly fragmented industry • Low level of industry-academia partnerships • Low margins • Government price controls • Most Indian companies are small by world standards • Industry concentrated at lower end of value chain • Lack of experience in drug discovery • Low levels of per capita medical expenditure 12
  • 13. Industry Drivers Economic growth, population, urbanization, demographic changes and the emergence of lifestyle diseases • Economic growth: The Indian economy’s recent growth expanded the middle-class and grew the healthcare market, a trend that is expected to continue. Increasingly health aware middle class with disposable income. • Consumer healthcare spending is expected to increase to 13% of GDP by 2015. • Population growth: The population is expected to grow to 1.24 Bn by 2015, while the aging population is expected to increase to 112 Mn, opening up a new healthcare dimension. • Middle-class growth: Households with over US$5,000 annual income are expected to increase to 63.8 Mn by 2015. • Working age and urban population prone to lifestyle diseases, as a proportion of overall population, is expected to increase from 28% in 2001 to around 31% by 2015. Mindset shift of urban Indian consumers from treating illness to managing wellness 13
  • 14. Generics & Services Sector Overview API, formulations and contract services (CRAMS) • India’s active pharmaceutical ingredients (API) industry with estimated sales US$4.1 Bn is the world’s 3rd largest after China and Italy • India manufactures over 400 APIs and supplies to about 50 countries; exports account for around 70% of sales. • India’s domestic formulations market is projected to grow at a CAGR of 13% to an estimated US$15 Bn by 2015. • At 30% growth YOY, CRAMS is the fast growing segment in the Indian pharma – with contract research contributing 29% and contract manufacturing contributing 66%. • Globally, the outsourcing trends are expected to grow further with the contract manufacturing market size at US$ 45 Bn (US$ 29 billion from formulations and US$ 16 Bn from APIs) • Contract research market size is estimated to be at ~ US$ 38 Bn (US$ 11 Bn from Drug Discovery and US$ 27 Bn from Clinical Research). 14
  • 15. Indian Pharma R&D The beginning of innovation 15
  • 16. Internal R&D Programs NCE Pipelines of Indian Pharma Company Pre-Clinical Phase I Phase II Phase III Total Lupin 4 1 2 3 10 Dr. Reddy’s 4 2 3 1 10 Biocon 4 - 1 2 7 Glenmark 4 - 2 - 6 Ranbaxy 8 1 1 - 10 Piramal Healthcare 2 - 3 - 5 Cadila - 3 1 - 4 Torrent 5 1 - - 6 Wockhardt 4 1 1 - 6 Sun Pharma 3 1 - - 4 Total 38 10 14 6 69 16
  • 17. Discovery & commercialization deals Date Company Indian Partner Description 2010 Endo Pharma Biocon’s subsidiary Syngene First deal on discovery of a biological International therapeutic entity for oncology 2009 BMS Biocon’s subsidiary Syngene Agreement to develop integrated drug International discovery and development capabilities 2009 Pfizer Aurobindo Pharma Commercialize generic products in US and EU 2009 Pfizer Claris Lifesciences Commercialize off-patent drugs in the US, Canada, Australia, New Zealand and Europe 2009 GSK DRL Market DRL’s 100 branded pharmaceuticals in emerging markets such as Africa, West Asia, Latin America and Asia-Pacific, excluding India 2009 Novavax Cadila Pharmaceuticals Joint venture to develop, manufacture and commercialize vaccines, drugs and diagnostics 2009 UCB Pharma Alembic Apply Alembic's NDDS for UCB’s epilepsy drug 2008 Eli Lilly Piramal Healthcare, Jubilant Development of molecules from pre-clin to Ph II Organosys and Suven 2007 Merck Piramal, Orchid and Advinus R&D collaboration for developing new drugs Therapeutics Evolution from (pure) Cost basis Shared risk/reward R&D innovation expertise 17
  • 18. Acquisitions… a snapshot of recent deals Date Acquirer Target Description 2010 Hospira Orchid Chemicals and Acquisition of beta-lactam Pharmaceuticals generics injectibles business 2009 Perrigo 85 % stake in Vedants Move API production from Company, OTC Drugs and Fine Germany and Israel to India producer Chemicals 2008 Japan-based Ranbaxy Acquisition of global generics Daiichi business 2008 Singapore's Dabur pharma Acquisition of oncology API Fresenius Kabi manufacturing capabilities 2009 Sanofi Aventis (Merieux Alliance's 80 % Strengthen vaccine portfolio stake in) Shantha Biotech and accelerate growth in strategic emerging markets 2009 Pfizer Vetnex Acquisition of the animal healthcare business 18
  • 19. Thank You! Harshawardhan Bal, PhD Stem Cell Capital www.stemcellcapital.com Tel: +1 717 557 8247 (cell) harsh.bal@stemcellcapital.com 19