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Results Presentation
             FY 2012
SAFE HARBOR


  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



     SNAPSHOT




     GROWTH VERTICALS




     FINANCIAL HIGHLIGHTS




                            3
SNAPSHOT
INTRODUCTION


           Biocon is an emerging, global Bio-pharmaceutical
    enterprise, focused on innovation to develop affordable products
                               and services
     for patients, partners and healthcare systems across the world.
 Biocon is committed towards:

         Reducing therapy costs of chronic diseases. (diabetes, cancer & auto-immune diseases)



                   Strategic Research and marketing partnerships that provide global access



         Leveraging the India advantage to deliver high value, licensable R&D assets




                                                                                                 5
FY12 HIGHLIGHTS


      Financial Performance

      • Group Revenue at Rs. 2,148 Crores (16% YoY growth)
      • EBITDA and PAT Margin at 27% and 16% respectively


      Research & Development

       • Itolizumab 52-week study successfully meets primary & secondary endpoints
       • Phase III trials commenced for Biosimilar Trastuzumab (Herceptin, Mylan alliance)
       • Global biosimilar Insulin trials nearing completion


      Strategic Alliances

      • 20+ new partnerships initiated in Syngene, including big pharma
      • Amicable conclusion of biosimilar Insulin partnership with Pfizer
                                                                                             6
MANAGING THE FUTURE

                                                            ANDAs & 505b2 filings


                                               Small
                                              Molecules


                                                                                    Newer markets;
Integrated                                                                           Progressing to
offerings from             Research                               Biosimilars
                                                                                           Devices
discovery to clinics       Services                              (Biologics &
                                              Growth               Insulins)
                                              Verticals




                 Greater          Novel                     Branded             Rapidly growing,
                                 Molecules                Formulations     India-centric business
             risk-reward
               paradigm


                                      EMERGING MARKETS FOCUS
                                        EMERGING MARKETS FOCUS                                        7
GROWTH VERTICALS
SMALL MOLECULES & BIOSIMILARS




    Small
   Molecules



      Biosimilar
        MAbs
       (Mylan)



   Biosimilar
    Insulins


                                9
BIOSIMILARS COMMERCIALIZATION PARTNER: MYLAN

Monoclonal Antibodies (MAbs)
                           Combines Biocon's R&D and manufacturing prowess of
                           biologics with Mylan’s regulatory & commercialization
                                      capabilities in the US and Europe

                Market Value of Portfolio in 2011: ~33 Bn USD
                    Exclusive collaboration for development and commercialization of
                                                   .
                                          complex biosimilars.
                       Basket of Products with patent expiries 2015 onward
               (Trastuzumab, Peg-filgrastim, Bevacizumab, Adalimumab, Eternacept)

                     Mylan and Biocon to share development and capital costs.

            Mylan will have exclusive commercialization rights in the regulated markets;
                                        profits to be shared

            Biocon and Mylan to have co-exclusive commercialization rights in other markets.

                                                                                               10
INSULINS: GLOBAL OPPORTUNITY


                         Total 2011 Insulin Market: USD ~17 Bn
                                                                                                                            USD
                                                                                                                   13%     ~17 Bn
                 rh insulin                                                                               23%
                    20%
                                                                                                 17%
                                    lispro
                                     14%                                               43%


    glargine                         detemir                     USD         4%
      32%                              9%                       ~15 Bn

                                               glulisine
                                                  2%
                          aspart
                           23%
                                                                  2010    rh Insulin Glargine   Lispro   Aspart   Others     2011

          Market Breakup by Molecule                                            Growth Contribution by Molecule




Source: Estimates compiled from earnings releases of respective companies & IMS data                                          11
BIOSIMILAR INSULINS PORTFOLIO


        Committed to delivering affordable, quality insulin
                       to global markets




                                                              12
BRANDED FORMULATIONS: #1 Indian Insulin Company


        Biocon’s ranking*              Value Growth YoY*                   Biocon’s Volume
                                                                            Market share*
                                    Fastest growing Insulin company
   #4 in overall insulin market
                                    Biocon: 53%                       40 IU Insulin: 11%
   #3 in the 40 IU Insulin market   Sanofi Aventis: 29%               Glargine vials: 84%
   #1 in the Glargine vial market   Novo Nordisk: 25%



  INSUPen® ease

  Reusable delivery device based
  on proprietary German
  technology, capable of
  delivering both InsugenTM &
  BasalogTM launched in India



 * : ORG IMS MAT Feb 2012
                                                                                             13
BRANDED FORMULATIONS : CARVING A NICHE

                    Affordability Index*                    INDIA PRODUCT RANKINGS#
                                                   Cardiology
                  Basalog: 40%
                                                                           Myokinase    2
                  Insugen: 15%
                                                                              Clotide   2
                  Bestor: 30%                      Oncotherapeutics
                                                                        BioMAb EGFR     2
                  Statix: 25%
                                                                            Abraxane    3
                  Advacan: 45%                     Immunotherapy
                  Tacrograf: 30%                                               Psorid   1
                                                                                 Tbis   2
                  Evertor: 59%
                                                                                Picon   2
                  BioMAb EGFR: 53%
                                                   Nephrology
                  Picon: 37%                                                Tacrograf   2
                  Psorid: 26%                                   Renodapt & Renodapt S   3


*: Compared to the top selling competitor brand;
#: ORG IMS Jan MAT 2012
                                                                                            14
RESEARCH PARTNERSHIPS : HIGH POTENTIAL PRODUCT PIPELINE

 Product             Therapeutic Area      Drug               Partner         Discovery     Preclinical Phase I     Phase II     Phase III       Market


                     Diabetes           IN 105

                     Oncology /
                                        Itolizumab            CIMAb                                                                          #
  Novel Molecules*




                     Inflammation /
                     Auto immune

                     Oncology           Nimotuzumab           CIMAb


                     Oncology           Anti-CD 20            Vaccinex


                     Oncology           Fusion Proteins       IATRICa


                     Diabetes           Peptide Hybrid        Amylin


                     Oncology/
  Biosimilars*




                                                                                  Other MAbs &      Biosimilar
                                        Biosimilar MAbs       Mylan                 PEG- GCSF      Trastuzumab
                     Immunology

                     Diabetes           Insulin & Analogues                                                       rH Insulin, Glargine


                     Oncology             Others                                                                  GCSF, EPO


  * Includes molecules from collaborative programs;                      # Phase 3 TREAT PLAQ study In India, Phase 2(b) globally                         15
ANTI- CD6 MAB: ITOLIZUMAB

Drug Highlights

     Targets CD6
    CD6 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.
   CD6 binds ALCAM (activated leukocyte cell adhesion molecule) which is expressed on:
           Activated T, cells, B cells & monocytes.
           Skin fibroblasts, keratinocytes, rheumatoid arthritis synovium.


 TREAT-PLAQ Study in Psoriasis

                                    Total Patient Enrollment                                223
                                             Trial Duration                            52 Weeks
                                    Interim Data Presented*                            28 Weeks


 * 52-week clinical study report; the regulatory package is currently being prepared for submission to the authorities. Key data would
 be shared in concurrence with the submission.                                                                                           16
TREAT PLAQ STUDY: SUMMARY OF 28-WEEK INTERIM RESULTS


  PRIMARY ENDPOINT                                                                   Result*
  Statistically significant patient cohort with ≥ PASI 75 Vs. placebo at 12 Weeks        

  SECONDARY ENDPOINTS
  Significant Proportion of subjects achieving PASI 50 and PASI 90                       
  Safety & Tolerability                                                                  
  Improvement in PGA scores                                                              
  Considerable Proportion of subjects with PGA score of “clear” or “minimal”             


 PASI: Psoriasis Area Severity Index   PGA: Physicians Global Assessment            *p <0.05   17
TREAT PLAQ STUDY: EFFICACY RESULTS
 Representative patient samples from each arm.
             Week       Baseline                 12 Weeks   28 Weeks

     Trial Arm


    Induction
    Dose Arm




   Fixed Dose
          Arm




  Placebo Arm



                                                                       18
BIOCON RESEARCH CENTRE


        State-of-the-art Integrated Research & Development Centre



                                          First-of-its kind in South east Asia

                                          Venue for world-class research on
                                           biologics

                                          Spread across 200,000 sq. ft. with:
                                                 Molecular Biology Lab
                                                 Biologics Process Science Labs
                                                 Formulations Development Lab
                                                 Molecular Characterization Lab
                                                 Functional Bioassay Lab
                                                 Preclinical & Clinical Development Groups



                                                                                         19
RESEARCH SERVICES: VALUE-BASED POSITIONING


      Integrated Model spanning discovery & early
        development to late stage clinical studies
                                                              Component
                                                                 Play


   Large Portfolio of Offerings combining Chemistry &
         Biologics expertise with cost advantage        Cluster Play




   Custom partnership models ranging from FTE based            Integrated
                to risk-reward models


                                                        Incubative
     Clientele comprising of 100+ large and mid-size
              pharma & biotech companies
                                                                            20
FINANCIAL HIGHLIGHTS
TOP LINE# & BOTTOM LINE#
                                                                INR crore


                 Q4 FY12       Q4 FY11      FY12         FY11
      Revenue      612          488         2148         1858
      EBIDTA       156          148         579          573
                         26%          30%          27%          31%
      PAT          98            94         338          340
                         16%          19%          16%          18%
      EPS           5            5          17           17




                                                                            22
Thank You

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Biocon Results Presentation April 2012

  • 2. SAFE HARBOR 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 SNAPSHOT GROWTH VERTICALS FINANCIAL HIGHLIGHTS 3
  • 5. INTRODUCTION Biocon is an emerging, global Bio-pharmaceutical enterprise, focused on innovation to develop affordable products and services for patients, partners and healthcare systems across the world. Biocon is committed towards: Reducing therapy costs of chronic diseases. (diabetes, cancer & auto-immune diseases) Strategic Research and marketing partnerships that provide global access Leveraging the India advantage to deliver high value, licensable R&D assets 5
  • 6. FY12 HIGHLIGHTS Financial Performance • Group Revenue at Rs. 2,148 Crores (16% YoY growth) • EBITDA and PAT Margin at 27% and 16% respectively Research & Development • Itolizumab 52-week study successfully meets primary & secondary endpoints • Phase III trials commenced for Biosimilar Trastuzumab (Herceptin, Mylan alliance) • Global biosimilar Insulin trials nearing completion Strategic Alliances • 20+ new partnerships initiated in Syngene, including big pharma • Amicable conclusion of biosimilar Insulin partnership with Pfizer 6
  • 7. MANAGING THE FUTURE ANDAs & 505b2 filings Small Molecules Newer markets; Integrated Progressing to offerings from Research Biosimilars Devices discovery to clinics Services (Biologics & Growth Insulins) Verticals Greater Novel Branded Rapidly growing, Molecules Formulations India-centric business risk-reward paradigm EMERGING MARKETS FOCUS EMERGING MARKETS FOCUS 7
  • 9. SMALL MOLECULES & BIOSIMILARS Small Molecules Biosimilar MAbs (Mylan) Biosimilar Insulins 9
  • 10. BIOSIMILARS COMMERCIALIZATION PARTNER: MYLAN Monoclonal Antibodies (MAbs) Combines Biocon's R&D and manufacturing prowess of biologics with Mylan’s regulatory & commercialization capabilities in the US and Europe Market Value of Portfolio in 2011: ~33 Bn USD Exclusive collaboration for development and commercialization of . complex biosimilars. Basket of Products with patent expiries 2015 onward (Trastuzumab, Peg-filgrastim, Bevacizumab, Adalimumab, Eternacept) Mylan and Biocon to share development and capital costs. Mylan will have exclusive commercialization rights in the regulated markets; profits to be shared Biocon and Mylan to have co-exclusive commercialization rights in other markets. 10
  • 11. INSULINS: GLOBAL OPPORTUNITY Total 2011 Insulin Market: USD ~17 Bn USD 13% ~17 Bn rh insulin 23% 20% 17% lispro 14% 43% glargine detemir USD 4% 32% 9% ~15 Bn glulisine 2% aspart 23% 2010 rh Insulin Glargine Lispro Aspart Others 2011 Market Breakup by Molecule Growth Contribution by Molecule Source: Estimates compiled from earnings releases of respective companies & IMS data 11
  • 12. BIOSIMILAR INSULINS PORTFOLIO Committed to delivering affordable, quality insulin to global markets 12
  • 13. BRANDED FORMULATIONS: #1 Indian Insulin Company Biocon’s ranking* Value Growth YoY* Biocon’s Volume Market share* Fastest growing Insulin company #4 in overall insulin market Biocon: 53% 40 IU Insulin: 11% #3 in the 40 IU Insulin market Sanofi Aventis: 29% Glargine vials: 84% #1 in the Glargine vial market Novo Nordisk: 25% INSUPen® ease Reusable delivery device based on proprietary German technology, capable of delivering both InsugenTM & BasalogTM launched in India * : ORG IMS MAT Feb 2012 13
  • 14. BRANDED FORMULATIONS : CARVING A NICHE Affordability Index* INDIA PRODUCT RANKINGS# Cardiology Basalog: 40% Myokinase 2 Insugen: 15% Clotide 2 Bestor: 30% Oncotherapeutics BioMAb EGFR 2 Statix: 25% Abraxane 3 Advacan: 45% Immunotherapy Tacrograf: 30% Psorid 1 Tbis 2 Evertor: 59% Picon 2 BioMAb EGFR: 53% Nephrology Picon: 37% Tacrograf 2 Psorid: 26% Renodapt & Renodapt S 3 *: Compared to the top selling competitor brand; #: ORG IMS Jan MAT 2012 14
  • 15. RESEARCH PARTNERSHIPS : HIGH POTENTIAL PRODUCT PIPELINE Product Therapeutic Area Drug Partner Discovery Preclinical Phase I Phase II Phase III Market Diabetes IN 105 Oncology / Itolizumab CIMAb # Novel Molecules* Inflammation / Auto immune Oncology Nimotuzumab CIMAb Oncology Anti-CD 20 Vaccinex Oncology Fusion Proteins IATRICa Diabetes Peptide Hybrid Amylin Oncology/ Biosimilars* Other MAbs & Biosimilar Biosimilar MAbs Mylan PEG- GCSF Trastuzumab Immunology Diabetes Insulin & Analogues rH Insulin, Glargine Oncology Others GCSF, EPO * Includes molecules from collaborative programs; # Phase 3 TREAT PLAQ study In India, Phase 2(b) globally 15
  • 16. ANTI- CD6 MAB: ITOLIZUMAB Drug Highlights Targets CD6 CD6 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. CD6 binds ALCAM (activated leukocyte cell adhesion molecule) which is expressed on: Activated T, cells, B cells & monocytes. Skin fibroblasts, keratinocytes, rheumatoid arthritis synovium. TREAT-PLAQ Study in Psoriasis Total Patient Enrollment 223 Trial Duration 52 Weeks Interim Data Presented* 28 Weeks * 52-week clinical study report; the regulatory package is currently being prepared for submission to the authorities. Key data would be shared in concurrence with the submission. 16
  • 17. TREAT PLAQ STUDY: SUMMARY OF 28-WEEK INTERIM RESULTS PRIMARY ENDPOINT Result* Statistically significant patient cohort with ≥ PASI 75 Vs. placebo at 12 Weeks  SECONDARY ENDPOINTS Significant Proportion of subjects achieving PASI 50 and PASI 90  Safety & Tolerability  Improvement in PGA scores  Considerable Proportion of subjects with PGA score of “clear” or “minimal”  PASI: Psoriasis Area Severity Index PGA: Physicians Global Assessment *p <0.05 17
  • 18. TREAT PLAQ STUDY: EFFICACY RESULTS Representative patient samples from each arm. Week Baseline 12 Weeks 28 Weeks Trial Arm Induction Dose Arm Fixed Dose Arm Placebo Arm 18
  • 19. BIOCON RESEARCH CENTRE State-of-the-art Integrated Research & Development Centre  First-of-its kind in South east Asia  Venue for world-class research on biologics  Spread across 200,000 sq. ft. with:  Molecular Biology Lab  Biologics Process Science Labs  Formulations Development Lab  Molecular Characterization Lab  Functional Bioassay Lab  Preclinical & Clinical Development Groups 19
  • 20. RESEARCH SERVICES: VALUE-BASED POSITIONING Integrated Model spanning discovery & early development to late stage clinical studies Component Play Large Portfolio of Offerings combining Chemistry & Biologics expertise with cost advantage Cluster Play Custom partnership models ranging from FTE based Integrated to risk-reward models Incubative Clientele comprising of 100+ large and mid-size pharma & biotech companies 20
  • 22. TOP LINE# & BOTTOM LINE# INR crore Q4 FY12 Q4 FY11 FY12 FY11 Revenue 612 488 2148 1858 EBIDTA 156 148 579 573 26% 30% 27% 31% PAT 98 94 338 340 16% 19% 16% 18% EPS 5 5 17 17 22

Notes de l'éditeur

  1. This slide is to accompany the 90 sec pitch
  2. Biologics: Insulins+Mabs+EPO+filgastrim+somatropin (source- IMS)Insulin data: Published results