Biocon Investor Presentation_Sept_2011_Q1

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  • 1. Investor PresentationSeptember 2011

2. DISCLAIMERCertain statements in this release concerning our future growth prospects areforward-looking statements, which are subject to a number of risks,uncertainties and assumptions that could cause actual results to differ materiallyfrom those contemplated in such forward-looking statements. Important factorsthat could cause actual results to differ materially from our expectationsinclude, amongst others general economic and business conditions in India, ourability to successfully implement our strategy, our research and developmentefforts, our growth and expansion plans and technological changes, changes inthe value of the Rupee and other currency changes, changes in the Indian andinternational interest rates, change in laws and regulations that apply to theIndian and global biotechnology and pharmaceuticals industries, increasingcompetition in and the conditions of the Indian biotechnology andpharmaceuticals industries, changes in political conditions in India and changesin the foreign exchange control regulations in India. Neither our company, norour directors, nor any of their respective affiliates have any obligation to updateor otherwise revise any statements reflecting circumstances arising after thisdate or to reflect the occurrence of underlying events, even if the underlyingassumptions do not come to fruition.2 3. AGENDA BIOCON SNAPSHOT PRODUCTS (BRANDED FORMULATIONS) RESEARCH & DEVELOPMENT STRATEGIC ALLIANCES FINANCIAL HIGHLIGHTS 3 4. BIOCON SNAPSHOT 5. VISIONBiocon is an emerging, global Bio-pharmaceutical enterprisethat is focused on developing affordable products and servicesfor patients, partners and healthcare systems across the world.Biocon is committed to: Reducing therapy costs of chronic diseases. (Diabetes, cancerand immune-mediated diseases). Research and marketing partnerships that provide globalaccess. Leveraging the India cost advantage to deliver high value,licensable R&D assets.5 6. BUSINESS STRUCTURE & HOLDINGS61% | Promoters~5 % | Employees & ESOP trustSyngene International Ltd, India | 100% Custom research, drug discovery~34 % | PublicBiocon 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 subsidiaryNeoBiocon, Dubai | 50%Overseas subsidiary 6 7. A DIFFERENTIATED BUSINESS MODEL BALANCED PORTFOLIO : Products & Services~ 23%Revenue SELF-FINANCED R&DCAGR and AND MANUFACTURING PRODUCTS STRATEGIC RESEARCH &~ 17% MARKETING PARTNERSHIPS EBITDA CAGR RISK-BALANCED R&D PIPELINE: (excludingRESEARCH Axicorp)SERVICES Biosimilars & Novels Over the past COST EFFECTIVE New Drug Development5 years 7 8. PRODUCT PORTFOLIO: VERTICALSNew Molecules New chemistry- oriented molecules Biologics MAbs, IN-105,ItolizumabOther novel Small Molecules biologicsResearch ServicesStatins, Fidaxomicin,Syngene ImmunosuppressantsClinigeneInsulin Other Bio-pharma Insulin & analogsOrlistat & Other APIsBrandedFormulations Existing Portfolio Diabetology,Nephrology, Oncotherapeutics, Comprehensive Care, Cardiology, Portfolio Expansion AreasImmunotherapy 8 9. RESEARCH SERVICES9 10. GLOBAL SCALE MANUFACTURING BASE10 11. PRODUCTS (BRANDED FORMULATIONS) 12. PRODUCTS & MARKETS 12 13. THERAPEUTICS SEGMENTS (INDIA)13 14. BIOCONS INSULIN BUSINESS (INDIA)The 2007-2010 CAGR Biocons rankingBiocons market share byfigures for unit sales of volume:Insulin 40 IU: #20 in the OAD marketMarket: 11%rh-Insulin: 11% #3 in the rhe-Insulin market Biocon: 13%Glargine: 13% #2 in the Glargine marketNN: 9%Source : IMS HEALTH HAS+SSA DATA SEPT-MAT 1010 players in Biocon has the insulin both OADsspace Pens will be introduced in H2 2011 and insulins 60 of these are in the oral anti-diabetics space61 players operate in theanti-diabetics market14 15. Research & Development 16. HIGH POTENTIAL PRODUCT PIPELINEDiabetesIN 105Oncology /Inflammation /ItolizuMAbAuto immuneNovel Molecules OncologyAnti-EGFROncologyAnti-CD 20DiabetesPeptide HybridTargetedOncologyImmunoconjugatesOncology/Immunology Biosimilar MAbsBiosimilarsDiabetesInsulin & AnaloguesrH Insulin, GlarginerH Insulin, GlargineOncologyOthersGCSF, 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 HighlightsConjugated peptideLower 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 withbasal insulins.Proof of Concept : Stable tablet formulation.Established oral delivery17 18. IN-105 INDIA PHASE III RESULT SUMMARY SECONDARY END POINTS Efficacy Secondary Endpoints Statistically significant reduction in PPG during STMSignificant reduction in SMBG post prandial glucose excursion Safety Secondary EndpointsNo clinically significant hypoglycemiaVery low immunogenicity No neutralizing antibodies detected No effect on liver enzymesNo effect on lipid profiles No effect on renal function Efficacy Primary EndpointChange in Hb1Ac for IN-105 not statistically significantXdue to higher than anticipated placebo effect 18 19. ANTI-CD6 MAb: T1hDrug 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 1Day 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 weeksDrug Development Day 1Day 57 Data lock for Phase 2/3 clinical trial in Psoriasis done. Data analysis ongoing. Phase 1/2 double blindPlannedtrial in MS.Phase 2/3 double blind trialin RA by end of 2011.19 20. STRATEGICALLIANCES 21. STRATEGIC RESEARCH PARTNERSHIPS NOVEL PEPTIDE AmylinDiabetes INTEGRATED DD SERVICES BMS Discovery to commercialization IMMUNOCONJUGATED MAbs IATRICa Oncology BIOSIMILARSMylanOncology, Auto-Immune Diseases NOVEL APIs Optimer First-in-class anti-infective (C.difficile) BIOSIMILARSPfizer Diabetes BIO BETTER MAbs VaccinexOncology 21 22. BIOSIMILARS PARTNERSHIP: PFIZER Insulin and Insulin analogs Combines Biocons research and manufacturing capabilities with Pfizers global marketing prowessGlobal agreement for the Pfizer will have exclusiveBiocon will becommercialization of Bioconsrights (with some responsible for clinicalbiosimilar versions of Insulin exceptions) todevelopment,and Insulin Analog products: commercialize these manufacture, supply,rh- Insulin, Glargine, Aspart, products globally.and regulatoryand Lispro.approvals. Upfront from Pfizer USD 100 mn + New manufacturing facility setup milestone payments100 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 InsulinsSources: Biocons estimates complied from Industry reports23 24. BIOSIMILARS PARTNERSHIP: MYLANMonoclonal Antibodies (MAbs) Combines Biocons R&D and manufacturing of novel biologics/bio-generics with Mylans regulatory and commercialization capabilities in the US and EuropeExclusiveCollaboration is for a Mylan will haveBiocon and Mylancollaboration forbasket of products exclusiveto have co-development andwith patents expiringcommercializationexclusivecommercializationbetween 2014-18. rights in thecommercializationof complexregulated markets; rights in otherbiogenerics andMylan and Biocon toprofits to bemarkets.biosimilars, MAbs in share developmentshared.particular.and capital costs..Current market size for product portfolio in 2010 is ~USD 20 bn 24 25. FINANCIAL HIGHLIGHTS 26. TOP & BOTTOM LINE INR crore / USD mnFY08 FY09 FY10 FY11Revenue 1090 273 1673 364 2405 512 2814616EBITDA 33583388 84 509 108 630138Net profit*22556240 52 293 62 36880FY08-11: Avg.exch.rate in that fiscalQ1 FY12: USD 1 = INR 45* Net profit is pre-exceptional in table 1No exceptional items in FY10 and FY11.FY08-FY11 figures include Axicorp 26 27. REVENUE MIX: SEGMENT WISETotal Revenues (excluding Axicorp) FY11: INR 1844 Cr. Statins30% Insulins &Immunosuppressants Research18% Services 20% BrandedBiocon+ BBPL + BRL formulations 80% 10%Licensing IncomeOther Biopharma 5% 17%Approximate percentages as of 30 June 201127 28. Thank You