Biocon Investor Presentation_March_2012_9M

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Text of Biocon Investor Presentation_March_2012_9M

  • 1. Investor PresentationMarch 2012

2. SAFE HARBORCertain statements in this release concerning our future growth prospects are forward-looking statements, which are subject to a number of risks, uncertainties andassumptions that could cause actual results to differ materially from those contemplatedin such forward-looking statements. Important factors that could cause actual results todiffer materially from our expectations include, amongst others general economic andbusiness conditions in India, our ability to successfully implement our strategy, ourresearch and development efforts, our growth and expansion plans and technologicalchanges, changes in the value of the Rupee and other currency changes, changes in theIndian and international interest rates, change in laws and regulations that apply to theIndian and global biotechnology and pharmaceuticals industries, increasing competitionin and the conditions of the Indian biotechnology and pharmaceuticals industries,changes in political conditions in India and changes in the foreign exchange controlregulations in India. Neither our company, nor our directors, nor any of their respectiveaffiliates have any obligation to update or otherwise revise any statements reflectingcircumstances 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 BRANDED FORMULATIONS STRATEGIC ALLIANCES RESEARCH & DEVELOPMENT FINANCIAL HIGHLIGHTS3 4. BIOCON SNAPSHOT 5. INTRODUCTION Biocon is an emerging, global Bio-pharmaceutical enterprise,focused on innovation to develop affordable products and servicesfor 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. BUSINESS STRUCTURE & HOLDINGS BIOPHARMA SUBSIDIARIES Biocon Research , India | 100% R&D- Novel Molecules Biocon Biopharmaceuticals | 100% MAbs and Biosimilars Biocon Sdn. Bhd, Malaysia | 100% Overseas subsidiary ~61%| Promoters Biocon SA, Switzerland | 100% ~7%| Employees & ESOP trust BioconOverseas subsidiary NeoBiocon, UAE | 50%PRODUCTS ~32 % | PublicOverseas subsidiaryRESEARCH SERVICESSyngene International, India | 100%Custom research, drug discoveryClinigene International, India | 100% RESEARCHClinical developmentSERVICESSpanning the entire Value Chain with capabilities ranging from discovery to manufacturing6 7. A PORTFOLIO BASED APPROACHInsulins & OtherBranded ResearchNovel Statins Immuno BiopharmaFormulationsServices Molecules Suppressants PortfolioConstituents StatinsSimvastatin, Atorvastatin, Lovastatin, Rosuvastatin, Fluvastatin & Pravastatin Insulins & Insulin and analogs Immuno suppressantsTacrolimus, MMF & MPA Other Biopharma Orlistat, Fidaxomicin, 50+ other molecules Branded Formulations Diabetology, Cardiology, Nephrology, Oncology, Immunotherapy, Comprehensive Care Research ServicesSyngene (Custom Research)Clinigene (Clinical research) Novel MoleculesIN-105, Itolizumab and others7 8. A RISK BALANCED GROWTH STRATEGY SmallMolecules Research Biosimilars Services(Biologics &Growth Insulins)VerticalsNovel Branded MoleculesFormulationsEMERGING MARKETS FOCUSEMERGING MARKETS FOCUS8 9. RESEARCH SERVICES: From Labs to Clinics9 10. RESEARCH SERVICES: Value based PositioningIntegrated Model spanning across discovery & early Componentdevelopment to late stage clinical studiesPlay Cluster Play Large Portfolio of Offerings combining Chemistry & Biologics expertise with cost advantageIntegrated Custom partnership models ranging from FTEIncubative based to risk-reward models 10 11. BIOSIMILAR INSULIN PORTFOLIO Committed to delivering affordable, quality insulin to global markets rh-Insulin 30+ registrations in rh-Insulin: Emerging markets Phase 3 trial in EU Commercialized in several Basal insulin analoggeographies Strong regional partners Glargine Rapid acting insulin in major markets Active US-INDanalog Global Phase 1 trial ongoing Commercialized in IndiaRegionalMoleculePortfolioPartnershipsStatus 11 12. Diabetes Prevalence (% of population)Diabetics (absolute nos. )Source: International Diabetes Atlas 201112 13. INSULINS: GLOBAL OPPORTUNITY Total 2011 Insulin Market: USD ~17 BnUSD 13% ~17 Bn rh insulin 23%20% 17%lispro 14%43%glargine detemir USD32%9% 4%~15 Bnglulisine 2%aspart 23%2010rh Insulin Glargine Lispro Aspart Others 2011 Market Breakup by MoleculeGrowth Contribution by MoleculeSource: Biocons estimates compiled from earnings release of respective companies & IMS data13 14. BRANDED FORMULATIONS 15. BRANDED FORMULATIONS : THERAPEUTIC SEGMENTS15 16. BIOCONS INSULIN BUSINESS (INDIA) MAT January 2012 YoY Biocons rankingBiocons market share by growth for value sales of 40 volume: IU insulin: #4 in overall insulinMarket: 16%40 IU Insulin: 11% #3 in the 40 IU Insulin market 41%Biocon: Glargine vials: 84% #1 in the Glargine vial market Novo Nordisk: 19%Source: IMS Health MAT, January 201210 players in Biocon has the insulin both OADsspace and insulins 60 of these are in the oral anti-diabetics space63 players operate in theanti-diabetics market16 17. BRANDED FORMULATIONS : INSUPen ease LAUNCHDesigned for accuracy, efficiency, safety & economy. Launched in October, 2011 Based on proprietary German technology Reusable delivery device capable of delivering both InsugenTM & BasalogTM One Call Does All Support helpline17 18. STRATEGIC ALLIANCES 19. STRATEGIC PARTNERSHIPS Amylin Diabetes Peptide Hybrid CIMAbOncologyBioMAb EGFR, ItolizumabDiscovery IATRICaOncologyImmuno-conjugated MAbs Vaccinex OncologyBiobetter MAbsFirst in Class OptimerFidaxomicinAnti InfectiveCommercializationOncology &Mylan BiosimilarsAuto ImmuneDiscovery to Research ServicesBMSIntegrated DD ServicesCommercialization19 20. BIOSIMILARS COMMERCIALIZATION PARTNERSHIP: MYLANMonoclonal Antibodies (MAbs)Combines Biocons R&D and manufacturing prowess ofnovel biologics/ bio-generics with Mylans 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 biogenerics and biosimilars. Basket of Products with patent expiries 2015 onwards(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.20 21. FIDAXOMICIN COMMERCIALIZATION PARTNERSHIP: OPTIMERFirst-in-class Anti-InfectiveCombines Biocons R&D and manufacturing prowess ofnovel biologics/ bio-generics with Optimers proprietarymolecule technologyExclusive collaboration for manufacture & supply of .Fidaxomicin API for DIFICIDTM & DIFICLIRTM tablets Extension of earlier relationship where Biocon helped Optimerwith the product development Launched in US, Approval received for EU. 21 22. Research & Development 23. RESEARCH PARTNERSHIPS : HIGH POTENTIAL PRODUCT PIPELINE US IND filed by partner (Amylin) for AC165198 Several Bi-specific fusion proteins under development with IATRICa * Including molecules from collaborative programs23 24. ANTI-CD6 MAb: ItolizumabDrug Highlights Targets CD6CD6 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.Drug Development : Database lock for Phase II(b) clinical trial in Psoriasis done. Data Analysis ongoing TREAT-PLAQ Study in Psoriasis Total Patient Enrollment 223Trial Duration52 WeeksInterim Data Presented28 Weeks 24 25. TREAT PLAQ STUDY: SUMMARY OF RESULTS#PRIMARY ENDPOINT Result*Statistically significant patient cohort with PASI 75 at 12 Weeks SECONDARY ENDPOINTSSignificant Proportion of subjects achieving PASI 50 and PASI 90Safety & 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