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Investor Presentation
    September 2011
DISCLAIMER


  Certain statements in this release concerning our future growth prospects are
  forward-looking statements, which are subject to a number of risks,
  uncertainties and assumptions that could cause actual results to differ materially
  from those contemplated in such forward-looking statements. Important factors
  that could cause actual results to differ materially from our expectations
  include, amongst others general economic and business conditions in India, our
  ability to successfully implement our strategy, our research and development
  efforts, our growth and expansion plans and technological changes, changes in
  the value of the Rupee and other currency changes, changes in the Indian and
  international interest rates, change in laws and regulations that apply to the
  Indian and global biotechnology and pharmaceuticals industries, increasing
  competition in and the conditions of the Indian biotechnology and
  pharmaceuticals industries, changes in political conditions in India and changes
  in the foreign exchange control regulations in India. Neither our company, nor
  our directors, nor any of their respective affiliates have any obligation to update
  or otherwise revise any statements reflecting circumstances arising after this
  date or to reflect the occurrence of underlying events, even if the underlying
  assumptions do not come to fruition.


                                                                                        2
AGENDA



     BIOCON SNAPSHOT


     PRODUCTS (BRANDED FORMULATIONS)


     RESEARCH & DEVELOPMENT


     STRATEGIC ALLIANCES


     FINANCIAL HIGHLIGHTS



                                       3
BIOCON SNAPSHOT
VISION



    Biocon is an emerging, global Bio-pharmaceutical enterprise
    that is focused on developing affordable products and services
    for patients, partners and healthcare systems across the world.

    Biocon is committed to:

    • Reducing therapy costs of chronic diseases. (Diabetes, cancer
      and immune-mediated diseases).

    • Research and marketing partnerships that provide global
      access.

    • Leveraging the India cost advantage to deliver high value,
      licensable R&D assets.
                                                                      5
BUSINESS STRUCTURE & HOLDINGS



  61% | Promoters
  ~5 % | Employees & ESOP trust            Syngene International Ltd, India | 100%
                                           Custom research, drug discovery
  ~34 % | Public                  Biocon   Clinigene International Ltd, India | 100%
                                           Clinical development

                                           Biocon Research, India | 100%
                                           R&D- Novel Molecules

                                           Biocon Biopharmaceuticals Pvt Ltd | 100%
                                           MAbs and Biosimilars

                                           Biocon SA, Switzerland | 100%
                                           Overseas subsidiary

                                           Biocon Sdn.Bhd, Malaysia | 100%
                                           Overseas subsidiary

                                            NeoBiocon, Dubai | 50%
                                            Overseas subsidiary




                                                                                       6
A DIFFERENTIATED BUSINESS MODEL



                         BALANCED PORTFOLIO :
                         Products & Services            ~ 23%
                                                        Revenue
                         SELF-FINANCED R&D
                                                        CAGR and
                         AND MANUFACTURING
     PRODUCTS
                         STRATEGIC RESEARCH &          ~ 17%
                         MARKETING PARTNERSHIPS
                                                       EBITDA CAGR
                         RISK-BALANCED R&D PIPELINE:   (excluding
      RESEARCH                                         Axicorp)
      SERVICES           Biosimilars & Novels
                                                       Over the past
                         COST EFFECTIVE
                         New Drug Development          5 years

                                                                       7
PRODUCT PORTFOLIO: VERTICALS




                                                        New Molecules
                                                       New chemistry-
                                                     oriented molecules


                                                         Biologics
                                               MAbs, IN-105,
                                                Itolizumab
                                                Other novel
                               Small Molecules   biologics
                                                                          Research Services
                                Statins, Fidaxomicin,                              Syngene
                               Immunosuppressants                                  Clinigene

                                      Insulin                               Other Bio-pharma
                                 Insulin & analogs                        Orlistat & Other APIs
                                                          Branded
                                                        Formulations
       Existing Portfolio                                 Diabetology,
                                                  Nephrology, Oncotherapeutics,
                                                 Comprehensive Care, Cardiology,
   Portfolio Expansion Areas
                                                        Immunotherapy                             8
RESEARCH SERVICES




                    9
GLOBAL SCALE MANUFACTURING BASE




                                  10
PRODUCTS (BRANDED FORMULATIONS)
PRODUCTS & MARKETS




                     12
THERAPEUTICS SEGMENTS (INDIA)




                                13
BIOCON’S INSULIN BUSINESS (INDIA)


                                                    The 2007-2010 CAGR
     Biocon’s ranking                                                                                Biocon’s market share by
                                                    figures for unit sales of
                                                                                                     volume:
                                                    Insulin 40 IU:



     #20 in the OAD market                          Market:   11%                                  rh-Insulin:   11%
     #3 in the rhe-Insulin market                   Biocon:   13%                                  Glargine:   13%
     #2 in the Glargine market                      NN:   9%
  Source : IMS HEALTH – HAS+SSA DATA– SEPT-MAT 10

                                                                                                            10 players in
                                                                                 Biocon has                 the insulin
                                                                                 both OADs                  space
   Pens will be introduced in H2 2011
                                                                                 and insulins



                                                                     60 of these are in the oral
                                                                     anti-diabetics space

                                                          61 players operate in the
                                                          anti-diabetics market
                                                                                                                                14
Research & Development
HIGH POTENTIAL PRODUCT PIPELINE


                      Diabetes              IN 105
                      Oncology /
                      Inflammation /        ItolizuMAb
                      Auto immune
    Novel Molecules   Oncology              Anti-EGFR

                      Oncology              Anti-CD 20

                      Diabetes              Peptide Hybrid
                                            Targeted
                      Oncology
                                            Immunoconjugates

                      Oncology/Immunology   Biosimilar MAbs
    Biosimilars
                      Diabetes              Insulin & Analogues                    rH Insulin, Glargine
                                                                                    rH Insulin, Glargine


                      Oncology              Others                                  GCSF, EPO




   2 novel drugs in late stage clinical trials
   Oral Insulin : Potentially addressing 300 million diabetes patients worldwide
   Anti-CD6 : Data Lock for Phase 3 Psoriasis

                                                                                                           16
LEAD PROGRAM: ORAL INSULIN IN-105

 Drug Highlights

    Conjugated peptide
    Lower immunogenicity and mitogenicity.
    Comparable safety and good clearance profile.
    Metabolically equivalent.

    Monotherapy.
    Combination therapy with metformin,
    sulfonylurea, PPAR agonists, DPP4i.
    Pre-meal insulin in combination with
    basal insulins.

    Proof of Concept : Stable tablet formulation.

    Established oral delivery




                                                    17
IN-105 INDIA PHASE III RESULT SUMMARY




         SECONDARY END POINTS
     Efficacy – Secondary Endpoints
           Statistically significant reduction in PPG during STM          
          Significant reduction in SMBG post prandial glucose excursion   
     Safety – Secondary Endpoints
          No clinically significant hypoglycemia                          
          Very low immunogenicity                                         
          No neutralizing antibodies detected                             
          No effect on liver enzymes                                      
          No effect on lipid profiles                                     
          No effect on renal function                                     
      Efficacy – Primary Endpoint
          Change in Hb1Ac for IN-105 not statistically significant        X
                  due to higher than anticipated placebo effect               18
ANTI-CD6 MAb: T1h

Drug Highlights
   Target CD6                                                           o.4mg/kg once in 4 weeks
   is a type 1 cell membrane glycoprotein belonging to the
   scavenger receptor cysteine-rich (SRCR) super family group B.
   CD6 is predominantly expressed by
   T cells & a B cell subset.                                           Day 1        Day 29
   CD6 binds ALCAM (activated leukocyte cell adhesion molecule)
   which is expressed on:
      Activated T, cells, B cells & monocytes.
      Skin fibroblasts, keratinocytes, rheumatoid arthritis synovium.
                                                                        0.8mg/kg once in 4 weeks
Drug Development
                                                                         Day 1      Day 57
 Data lock for Phase 2/3 clinical trial in Psoriasis done. Data
 analysis ongoing.
                   Phase 1/2 double blind
  Planned          trial in MS.
                  Phase 2/3 double blind trial
                  in RA by end of 2011.


                                                                                              19
STRATEGIC
ALLIANCES
STRATEGIC RESEARCH PARTNERSHIPS

                             NOVEL PEPTIDE
               Amylin        Diabetes


                             INTEGRATED DD SERVICES
                 BMS         Discovery to commercialization


                             IMMUNOCONJUGATED MAbs
               IATRICa       Oncology



                             BIOSIMILARS
                Mylan        Oncology, Auto-Immune Diseases


                             NOVEL APIs
               Optimer       First-in-class anti-infective (C.difficile)


                             BIOSIMILARS
                Pfizer       Diabetes



                             BIO BETTER MAbs
               Vaccinex      Oncology
                                                                           21
BIOSIMILARS PARTNERSHIP: PFIZER


 Insulin and Insulin analogs
                           Combines Biocon's research and manufacturing
                           capabilities with Pfizer's global marketing prowess

        Global agreement for the         Pfizer will have exclusive    Biocon will be
        commercialization of Biocon's    rights (with some             responsible for clinical
        biosimilar versions of Insulin   exceptions) to                development,
        and Insulin Analog products:     commercialize these           manufacture, supply,
        rh- Insulin, Glargine, Aspart,   products globally.            and regulatory
        and Lispro.                                                    approvals.


         Upfront from Pfizer USD 100 mn
       + New manufacturing facility setup milestone payments          100 USD mn
       +Development, regulatory & launch milestone payments           150 USD mn
       +Payments linked to supplies.
       + Payments linked to global sales.
                                                                                                  22
GLOBAL INSULIN MARKET (2010)

 Total 2010 Insulin Market USD ~15 bn                                            ~ USD 20 bn in 2020




                                                                 Growth forecast of ~6% per annum*


                                                                 *Factoring the advent of Biosimilar Insulins
    Sources: Biocon’s estimates complied from Industry reports
                                                                                                                23
BIOSIMILARS PARTNERSHIP: MYLAN


Monoclonal Antibodies (MAbs)

                           Combines Biocon's R&D and manufacturing of novel
                           biologics/bio-generics with Mylan’s regulatory and
                           commercialization capabilities in the US and Europe

    Exclusive              Collaboration is for a   Mylan will have      Biocon and Mylan
    collaboration for      basket of products       exclusive            to have co-
    development and        with patents expiring    commercialization    exclusive
    commercialization      between 2014-18.         rights in the        commercialization
    of complex                                      regulated markets;   rights in other
    biogenerics and        Mylan and Biocon to      profits to be        markets.
    biosimilars, MAbs in   share development        shared.
    particular.            and capital costs.

    .
        Current market size for product portfolio in 2010 is ~USD 20 bn
                                                                                         24
FINANCIAL HIGHLIGHTS
TOP & BOTTOM LINE


     INR crore / USD mn      FY08       FY09     FY10               FY11
    Revenue               1090 273   1673 364   2405 512 2814                  616
    EBITDA                 335  83    388 84     509 108 630                    138
    Net profit*            225  56    240 52     293 62   368                    80




                                                        FY08-11: Avg.exch.rate in that fiscal
                                                        Q1 FY12: USD 1 = INR 45
                                                        * Net profit is pre-exceptional in table 1
                                                        No exceptional items in FY10 and FY11.
                                                        FY08-FY11 figures include Axicorp

                                                                                                     26
REVENUE MIX: SEGMENT WISE

                        Total Revenues (excluding Axicorp) FY11: INR 1844 Cr.




                                                           Statins
                                                            30%                 Insulins &
                                                                            Immunosuppressants
       Research                                                                    18%
       Services
         20%                                                                         Branded
                  Biocon+ BBPL + BRL                                               formulations
                         80%                                                           10%

                                                Licensing Income      Other Biopharma
                                                       5%                   17%




                              Approximate percentages as of 30 June 2011


                                                                                                  27
Thank You

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Biocon Investor Presentation_Sept_2011_Q1

  • 1. Investor Presentation September 2011
  • 2. DISCLAIMER Certain statements in this release concerning our future growth prospects are forward-looking statements, which are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those contemplated in such forward-looking statements. Important factors that could cause actual results to differ materially from our expectations include, amongst others general economic and business conditions in India, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither our company, nor our directors, nor any of their respective affiliates have any obligation to update or otherwise revise any statements reflecting circumstances arising after this date or to reflect the occurrence of underlying events, even if the underlying assumptions do not come to fruition. 2
  • 3. AGENDA BIOCON SNAPSHOT PRODUCTS (BRANDED FORMULATIONS) RESEARCH & DEVELOPMENT STRATEGIC ALLIANCES FINANCIAL HIGHLIGHTS 3
  • 5. VISION Biocon is an emerging, global Bio-pharmaceutical enterprise that is focused on developing affordable products and services for patients, partners and healthcare systems across the world. Biocon is committed to: • Reducing therapy costs of chronic diseases. (Diabetes, cancer and immune-mediated diseases). • Research and marketing partnerships that provide global access. • Leveraging the India cost advantage to deliver high value, licensable R&D assets. 5
  • 6. BUSINESS STRUCTURE & HOLDINGS 61% | Promoters ~5 % | Employees & ESOP trust Syngene International Ltd, India | 100% Custom research, drug discovery ~34 % | Public Biocon Clinigene International Ltd, India | 100% Clinical development Biocon Research, India | 100% R&D- Novel Molecules Biocon Biopharmaceuticals Pvt Ltd | 100% MAbs and Biosimilars Biocon SA, Switzerland | 100% Overseas subsidiary Biocon Sdn.Bhd, Malaysia | 100% Overseas subsidiary NeoBiocon, Dubai | 50% Overseas subsidiary 6
  • 7. A DIFFERENTIATED BUSINESS MODEL BALANCED PORTFOLIO : Products & Services ~ 23% Revenue SELF-FINANCED R&D CAGR and AND MANUFACTURING PRODUCTS STRATEGIC RESEARCH & ~ 17% MARKETING PARTNERSHIPS EBITDA CAGR RISK-BALANCED R&D PIPELINE: (excluding RESEARCH Axicorp) SERVICES Biosimilars & Novels Over the past COST EFFECTIVE New Drug Development 5 years 7
  • 8. PRODUCT PORTFOLIO: VERTICALS New Molecules New chemistry- oriented molecules Biologics MAbs, IN-105, Itolizumab Other novel Small Molecules biologics Research Services Statins, Fidaxomicin, Syngene Immunosuppressants Clinigene Insulin Other Bio-pharma Insulin & analogs Orlistat & Other APIs Branded Formulations Existing Portfolio Diabetology, Nephrology, Oncotherapeutics, Comprehensive Care, Cardiology, Portfolio Expansion Areas Immunotherapy 8
  • 14. BIOCON’S INSULIN BUSINESS (INDIA) The 2007-2010 CAGR Biocon’s ranking Biocon’s market share by figures for unit sales of volume: Insulin 40 IU: #20 in the OAD market Market: 11% rh-Insulin: 11% #3 in the rhe-Insulin market Biocon: 13% Glargine: 13% #2 in the Glargine market NN: 9% Source : IMS HEALTH – HAS+SSA DATA– SEPT-MAT 10 10 players in Biocon has the insulin both OADs space Pens will be introduced in H2 2011 and insulins 60 of these are in the oral anti-diabetics space 61 players operate in the anti-diabetics market 14
  • 16. HIGH POTENTIAL PRODUCT PIPELINE Diabetes IN 105 Oncology / Inflammation / ItolizuMAb Auto immune Novel Molecules Oncology Anti-EGFR Oncology Anti-CD 20 Diabetes Peptide Hybrid Targeted Oncology Immunoconjugates Oncology/Immunology Biosimilar MAbs Biosimilars Diabetes Insulin & Analogues rH Insulin, Glargine rH Insulin, Glargine Oncology Others GCSF, EPO 2 novel drugs in late stage clinical trials Oral Insulin : Potentially addressing 300 million diabetes patients worldwide Anti-CD6 : Data Lock for Phase 3 Psoriasis 16
  • 17. LEAD PROGRAM: ORAL INSULIN IN-105 Drug Highlights Conjugated peptide Lower immunogenicity and mitogenicity. Comparable safety and good clearance profile. Metabolically equivalent. Monotherapy. Combination therapy with metformin, sulfonylurea, PPAR agonists, DPP4i. Pre-meal insulin in combination with basal insulins. Proof of Concept : Stable tablet formulation. Established oral delivery 17
  • 18. IN-105 INDIA PHASE III RESULT SUMMARY SECONDARY END POINTS Efficacy – Secondary Endpoints Statistically significant reduction in PPG during STM  Significant reduction in SMBG post prandial glucose excursion  Safety – Secondary Endpoints No clinically significant hypoglycemia  Very low immunogenicity  No neutralizing antibodies detected  No effect on liver enzymes  No effect on lipid profiles  No effect on renal function  Efficacy – Primary Endpoint Change in Hb1Ac for IN-105 not statistically significant X due to higher than anticipated placebo effect 18
  • 19. ANTI-CD6 MAb: T1h Drug Highlights Target CD6 o.4mg/kg once in 4 weeks is a type 1 cell membrane glycoprotein belonging to the scavenger receptor cysteine-rich (SRCR) super family group B. CD6 is predominantly expressed by T cells & a B cell subset. Day 1 Day 29 CD6 binds ALCAM (activated leukocyte cell adhesion molecule) which is expressed on: Activated T, cells, B cells & monocytes. Skin fibroblasts, keratinocytes, rheumatoid arthritis synovium. 0.8mg/kg once in 4 weeks Drug Development Day 1 Day 57 Data lock for Phase 2/3 clinical trial in Psoriasis done. Data analysis ongoing. Phase 1/2 double blind Planned trial in MS. Phase 2/3 double blind trial in RA by end of 2011. 19
  • 21. STRATEGIC RESEARCH PARTNERSHIPS NOVEL PEPTIDE Amylin Diabetes INTEGRATED DD SERVICES BMS Discovery to commercialization IMMUNOCONJUGATED MAbs IATRICa Oncology BIOSIMILARS Mylan Oncology, Auto-Immune Diseases NOVEL APIs Optimer First-in-class anti-infective (C.difficile) BIOSIMILARS Pfizer Diabetes BIO BETTER MAbs Vaccinex Oncology 21
  • 22. BIOSIMILARS PARTNERSHIP: PFIZER Insulin and Insulin analogs Combines Biocon's research and manufacturing capabilities with Pfizer's global marketing prowess Global agreement for the Pfizer will have exclusive Biocon will be commercialization of Biocon's rights (with some responsible for clinical biosimilar versions of Insulin exceptions) to development, and Insulin Analog products: commercialize these manufacture, supply, rh- Insulin, Glargine, Aspart, products globally. and regulatory and Lispro. approvals. Upfront from Pfizer USD 100 mn + New manufacturing facility setup milestone payments 100 USD mn +Development, regulatory & launch milestone payments 150 USD mn +Payments linked to supplies. + Payments linked to global sales. 22
  • 23. GLOBAL INSULIN MARKET (2010) Total 2010 Insulin Market USD ~15 bn ~ USD 20 bn in 2020 Growth forecast of ~6% per annum* *Factoring the advent of Biosimilar Insulins Sources: Biocon’s estimates complied from Industry reports 23
  • 24. BIOSIMILARS PARTNERSHIP: MYLAN Monoclonal Antibodies (MAbs) Combines Biocon's R&D and manufacturing of novel biologics/bio-generics with Mylan’s regulatory and commercialization capabilities in the US and Europe Exclusive Collaboration is for a Mylan will have Biocon and Mylan collaboration for basket of products exclusive to have co- development and with patents expiring commercialization exclusive commercialization between 2014-18. rights in the commercialization of complex regulated markets; rights in other biogenerics and Mylan and Biocon to profits to be markets. biosimilars, MAbs in share development shared. particular. and capital costs. . Current market size for product portfolio in 2010 is ~USD 20 bn 24
  • 26. TOP & BOTTOM LINE INR crore / USD mn FY08 FY09 FY10 FY11 Revenue 1090 273 1673 364 2405 512 2814 616 EBITDA 335 83 388 84 509 108 630 138 Net profit* 225 56 240 52 293 62 368 80 FY08-11: Avg.exch.rate in that fiscal Q1 FY12: USD 1 = INR 45 * Net profit is pre-exceptional in table 1 No exceptional items in FY10 and FY11. FY08-FY11 figures include Axicorp 26
  • 27. REVENUE MIX: SEGMENT WISE Total Revenues (excluding Axicorp) FY11: INR 1844 Cr. Statins 30% Insulins & Immunosuppressants Research 18% Services 20% Branded Biocon+ BBPL + BRL formulations 80% 10% Licensing Income Other Biopharma 5% 17% Approximate percentages as of 30 June 2011 27