JP Morgan Healthcare Conference                    January 9, 2012
SAFE HARBOR  Certain statements in this presentation concerning our future growth prospects  are forward-looking statement...
INTRODUCTION       Biocon is an emerging, global Bio-pharmaceutical enterprise,    focused on innovation to develop afford...
A RISK-BALANCED APPROACH                                                         ANDAs & 505b2 filings                    ...
BIOSIMILARS: GLOBAL OPPORTUNITY       Total 2010 Insulin Market USD ~15 Bn                       Total 2010 Biologics Mark...
A RISK-BALANCED APPROACH                                                         ANDAs & 505b2 filings                    ...
EMERGING MARKETS: HIGH GROWTH OPPORTUNITY        All Figures in USD Bn                                                1095...
EMERGING MARKETS: GROWTH SPECIFICS                                        • Current market size ~ 155 Bn USD#            G...
LEVERAGING EMERGING MARKETS                                                    50% of our    Presence in               A p...
NOVEL PROGRAMS
RESEARCH ASSET PIPELINE                           Diabetes                    IN 105     Novel Molecules*                 ...
Itolizumab: Phase III India            TREAT PLAQ Study(T1h MAb tREATment for PLAQue psoriasis)
ITOLIZUMAB: BACKGROUND  •   First-in-class molecule against a novel target  •   A humanized Anti-CD 6 monoclonal antibody ...
ITOLIZUMAB TREAT PLAQ STUDY: STUDY DESIGN                Double Blind, Placebo controlled, Randomized, Multi-centric,     ...
ITOLIZUMAB TREAT PLAQ STUDY: SUMMARY OF RESULTS  PRIMARY ENDPOINT                                                         ...
ITOLIZUMAB TREAT PLAQ STUDY: EFFICACY RESULTS            Proportion of patients achieving ≥ PASI 75                       ...
ITOLIZUMAB TREAT PLAQ STUDY: EFFICACY RESULTS Representative patient samples           Week       Baseline       12 Weeks ...
ITOLIZUMAB TREAT PLAQ STUDY: OVERALL CONCLUSIONS     First-in-class therapy, with a novel MOA and an excellent safety    ...
BI-SPECIFIC FUSION ANTIBODIES
BISB: BACKGROUND   Bi-specific Targeted Immuno-stimulatory   antibody based fusion proteins   Designed to target tumor and...
BISB: PRELIMINARY RESULTS                                                Experimental Mice at Day 18                      ...
RESEARCH SERVICES
RESEARCH SERVICES: INTEGRATED OFFERINGDrug Discovery and Development Continuum           Discovery                        ...
RESEARCH SERVICES: EVOLVING BUSINESS PARTNERSHIPS                                     Incubative                          ...
RESEARCH SERVICES: SYNGENE & CLINIGENE    All Figures in USD Mn                                           77              ...
FINANCIAL HIGHLIGHTS
BIOCON GROUP      All Figures in USD Mn                        408                                                        ...
NEAR-TERM GROWTH DRIVERS          Out licensing of assets to unlock value                  Leveraging Research Services wi...
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Innovative Science Affordable Medicine - JP Morgan_Biocon Health Conference January,2012

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Innovative Science Affordable Medicine - JP Morgan_Biocon Health Conference January,2012

  1. 1. JP Morgan Healthcare Conference January 9, 2012
  2. 2. SAFE HARBOR Certain statements in this presentation 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. 3. 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 3
  4. 4. A RISK-BALANCED APPROACH ANDAs & 505b2 filings Small Molecules Integrated Progressing offerings Biosimilars to Devices Research Services (Biologics & Growth Insulins) Verticals Itolizumab & Novel Branded Rapidly growing, Molecules Formulations India-centric business BISB 4 EMERGING MARKETS FOCUS EMERGING MARKETS FOCUS
  5. 5. BIOSIMILARS: GLOBAL OPPORTUNITY Total 2010 Insulin Market USD ~15 Bn Total 2010 Biologics Market* USD ~138 Bn Biocon’ s rh insulin Target 21% Opportunity lispro glargine 14% 32% detemir 8% aspart glulisine 23% 2% Expected to be USD ~20 Bn in 2020 Expected to be USD ~200 Bn in 2015* Biologics Includes MAbs, Vaccines, Growth Factors Source: Compiled from Industry reports, IMS data 5
  6. 6. A RISK-BALANCED APPROACH ANDAs & 505b2 filings Small Molecules Integrated Progressing offerings Biosimilars to Devices Research Services (Biologics & Growth Insulins) Verticals Itolizumab & Novel Branded Rapidly growing, Molecules Formulations India-centric business BISB 6 EMERGING MARKETS FOCUS EMERGING MARKETS FOCUS
  7. 7. EMERGING MARKETS: HIGH GROWTH OPPORTUNITY All Figures in USD Bn 1095 • 5-year Growth CAGR: 856 o Emerging markets: 14% o Developed markets: 5% 63% 605 • Emerging Market size expected to 74% double to ~$400bn by 2015 81% • Pharmerging nations account for 37% ~70% of current ROW markets 26% 19% 2005 2010 2015E Emerging Markets Developed MarketsSource: IMS Market Prognosis, April 2011 7
  8. 8. EMERGING MARKETS: GROWTH SPECIFICS • Current market size ~ 155 Bn USD# Generics • Expected to reach ~317 Bn USD by 2015 • BRIC nations to drive 73% of this growth • Current market size ~2.7 Bn USD* Biosimilar • CAGR of 14% over past 2 years Insulins • Estimated to be ~5 Bn USD by 2020 • Large potential for institutional and retail market access Biosimilar • Current market size ~5 Bn USD* Biologics • Rapidly growing at 14% CAGR for last 2 years#: IMS Institute of Healthcare Informatics 8*:Includes Innovator & Biosimilar Sales; (IMS, Evaluate Pharma),
  9. 9. LEVERAGING EMERGING MARKETS 50% of our Presence in A portfolio of revenues from over 70 more than Emerging countries 100 products Markets  Leveraging regional partnerships  Key Markets: LATAM, MENA, SEA  Revenue Share of EM in FY11 : ~50% up from 37% in FY08 9
  10. 10. NOVEL PROGRAMS
  11. 11. RESEARCH ASSET PIPELINE Diabetes IN 105 Novel Molecules* Oncology / Inflammation / Itolizumab Auto immune Oncology Nimotuzumab Oncology BVX 20 Oncology Fusion Proteins Diabetes AC165198  US IND filed by partner (Amylin) for AC165198  A large portfolio of bi-specific fusion proteins under development 11* Including molecules from collaborative programs
  12. 12. Itolizumab: Phase III India TREAT PLAQ Study(T1h MAb tREATment for PLAQue psoriasis)
  13. 13. ITOLIZUMAB: BACKGROUND • First-in-class molecule against a novel target • A humanized Anti-CD 6 monoclonal antibody • CD6 is predominantly expressed by T cells and a subset of B cells • Targeted for other autoimmune diseases including Psoriasis, RA, MS etc. TREAT-PLAQ Study in Psoriasis Objective: To evaluate safety & efficacy of Itolizumab in patients with active, moderate to severe chronic plaque psoriasis Total Patient Enrollment 223 Trial Duration 52 Weeks Interim Data Presented 28 Weeks 13
  14. 14. ITOLIZUMAB TREAT PLAQ STUDY: STUDY DESIGN Double Blind, Placebo controlled, Randomized, Multi-centric, Multi-Dose, parallel arm study 12 WEEKS 28 WEEKS Induction Dose Arm* Monthly Fixed Dose A Fixed Dose Arm* Monthly Fixed Dose Recruited Patients B Follow up maintenance Placebo Arm Bi-weekly Fixed Dose C *Induction dose: 0.4mg/kg Fixed Dose: 1.6mg/kg 14
  15. 15. ITOLIZUMAB TREAT PLAQ STUDY: SUMMARY OF RESULTS PRIMARY ENDPOINT Result* Statistically significant patient cohort with ≥ PASI 75 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 15
  16. 16. ITOLIZUMAB TREAT PLAQ STUDY: EFFICACY RESULTS Proportion of patients achieving ≥ PASI 75  The statistically significant PASI 75 response at 12 weeks indicates the drug is efficacious, with continued improvement at 28 weeks  PASI 75 response in patients with severe disease (baseline PASI > 20) was ~54% at 28 weeks  Placebo arm was placed on a bi-weekly fixed dose schedule Placebo Induction Dose Fixed Dose Induction Dose Fixed Dose at 12 weeks Arm** Arm Arm+ Arm+ o Statistically significant PASI 12 weeks 28 weeks 75 response at 28 weeks was observed PASI: Psoriasis Area Severity Index *p <0.05 vs. Placebo 16**4 week Induction dose: 0.4mg/kg/wk + Fixed Dose: 1.6mg/kg/ every 4 wks.
  17. 17. ITOLIZUMAB TREAT PLAQ STUDY: EFFICACY RESULTS Representative patient samples Week Baseline 12 Weeks 28 Weeks Trial Arm Drug Arm Drug Arm Placebo Arm 17
  18. 18. ITOLIZUMAB TREAT PLAQ STUDY: OVERALL CONCLUSIONS  First-in-class therapy, with a novel MOA and an excellent safety profile  Successfully achieved primary endpoint of PASI 75 at 12 weeks with continued improvement in efficacy over time  Very low infection rates observed compared to reported rates from other approved therapies (~10% compared to ~30-40%)  Promising preclinical and clinical efficacy data in other auto- immune diseases (RA,MS) 18
  19. 19. BI-SPECIFIC FUSION ANTIBODIES
  20. 20. BISB: BACKGROUND Bi-specific Targeted Immuno-stimulatory antibody based fusion proteins Designed to target tumor and stimulate anti-tumor immunity Circumvents tumor induced immune tolerance A large portfolio under development to target a wide array of human cancers 20
  21. 21. BISB: PRELIMINARY RESULTS Experimental Mice at Day 18 Untreated Control Commercial MAb BISB Untreated Control Commercial MAb BISB 21
  22. 22. RESEARCH SERVICES
  23. 23. RESEARCH SERVICES: INTEGRATED OFFERINGDrug Discovery and Development Continuum Discovery Development Pre- clinical Clinical Target Lead Identification Generation Lead Animal Safety Ph I- IV Regulatory Selection Filings Target Lead API and Drug product Validation Optimization Development Syngene Integration of Discovery, CMC & Clinical Development Clinigene 23
  24. 24. RESEARCH SERVICES: EVOLVING BUSINESS PARTNERSHIPS Incubative play Integrated play Cluster plays Component plays Innovative Strategic Tactical 24
  25. 25. RESEARCH SERVICES: SYNGENE & CLINIGENE All Figures in USD Mn 77 68 52 Revenue Growth : 24 % CAGR* EBIDTA margin ~ 30 % 15 20 21 Strong Cash flows, Healthy balance sheet FY 09 FY 10 FY 11 Revenues EBDITA Converted at a constant rate of 1 USD= INR 45.00 *3-year CAGR 25
  26. 26. FINANCIAL HIGHLIGHTS
  27. 27. BIOCON GROUP All Figures in USD Mn 408 Strong Top line Growth 3-yr CAGR 19% 332 driven by growth in emerging markets 265 EBIDTA margin ~30 %; Sustained by efficient cost management PAT margin ~20 % 128 101 83 Strong balance sheet, net cash 52 61 76 positive FY 09 FY 10 FY 11 Revenue EBIDTA PAT* Converted at a constant rate of 1 USD= INR 45.00 27* PAT pre-exceptional; All figures excluding divested German business Axicorp
  28. 28. NEAR-TERM GROWTH DRIVERS Out licensing of assets to unlock value Leveraging Research Services with differentiated offerings Focus on Emerging Markets through regional partnerships Enhancing Brand Equity in domestic & emerging markets Moving up the value chain with ANDA and 505b2 filings 28
  29. 29. Thank You

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