Biocon Investor Presentation (October '11)

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  • 1. Investor Presentation October 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 enterprise, focused on developing 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 & immune-mediated)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 Biocon Research , India | 100% R&D- Novel Molecules Biocon Biopharmaceuticals | 100% MAbs61%| Promoters Biocon , Malaysia | 100%PRODUCTS~5 % | Employees & ESOP trust Biocon Overseas subsidiary~34 % | Public Biocon SA, Switzerland | 100% Overseas subsidiary NeoBiocon, UAE | 50% Overseas subsidiary Syngene International, India | 100% Custom research, drug discovery RESEARCH Clinigene International, India | 100% SERVICES Clinical development6 7. 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 7 8. RESEARCH SERVICES8 9. PRODUCTS (BRANDED FORMULATIONS) 10. THERAPEUTICS SEGMENTS (INDIA)10 11. PRODUCTS & MARKETS INDIA PRODUCT RANKINGS* Diabetology Basalog1 Insugen 40IU 3 Cardiology Clotide1 Myokinase2 OncotherapeuticsBioMAb EGFR 2 Evertor2Abraxane3 * August MAT 2011 11 12. BIOCONS INSULIN BUSINESS (INDIA)MAT August 2011 YoY Biocons ranking Biocons market share bygrowth for value sales ofvolume:insulin: #4 in the overall insulin space Market: 26%40 IU Insulin: 11% #3 in the 40 IU Insulin marketBiocon: 46%Glargine vials: 62% #1 in the Glargine vial marketNovo Nordisk: 24%Source: IMS Health MAT, August 2011 10 players inBiocon has the insulinboth OADsspaceand insulins60 of these are in the oralanti-diabetics space 61 players operate in the anti-diabetics market 12 13. 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 helpline Expected to add further impetus to branded formulations sales in H2FY1213 14. Research & Development 15. HIGH POTENTIAL PRODUCT PIPELINEDiabetes IN 105Oncology /Novel Molecules*Inflammation / Itolizumab CIMAbAuto immuneOncology NimotuzumabCIMAbOncology Anti-CD 20 Vaccinex TargetedOncologyImmunoconjugatesIATRICaDiabetes Peptide Hybrid Amylin 2 novel drugs in late-stage clinical trials More molecules moving from labs to clinic* Including molecules from collaborative programs15 16. HIGH POTENTIAL PRODUCT PIPELINE ItolizuMAbPhase 3 study (TREAT-PLAQ) ongoing Expected to be complete by Q4FY12 BVX-20Phase 1 study is expected to start in Q1 of next year Phybrid Plan to submit an IND and commence phase 1 study by end of 2011.16 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 CD6o.4mg/kg once in 4 weeksis a type 1 cell membrane glycoprotein belonging to thescavenger 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 DevelopmentDay 1 Day 57 Database lock for Phase 3 clinical trial in Psoriasis done. Data analysis ongoing.PlannedInitiation of Phase 2 double blind trial in RA in the 2nd half of this fiscal.19 20. STRATEGIC ALLIANCES 21. STRATEGIC PARTNERSHIPS 21 22. BIOSIMILARS PARTNERSHIP: PFIZER Insulin and Insulin analogs Combines Biocons research and manufacturing capabilities with Pfizers global marketing prowessGlobal agreement for commercialization of Biocons biosimilar versions ofInsulin & Insulin Analogs: rh- Insulin, Glargine, Aspart, and Lispro.Pfizer will have exclusive rights (with some exceptions) to commercialize these products globally. Biocon will be responsible for clinical development, manufacture, supply, &regulatory approvals.Upfront from Pfizer 100 USD mn+ New manufacturing facility setup milestone payments 100 USD mn (in escrow a/c)+ Development, regulatory & launch milestone payments 150 USD mn+ Payments linked to supplies and sales. 22 23. GLOBAL INSULIN MARKET (2010) Total 2010 Insulin Market USD ~15 bn~ USD 20 bn in 2020 Lantus22% Novolog 32% Humalog 8%Novomix 10% Levemir14%14%Rh Insulin Growth forecast of ~6% per annum*Sources: Biocons estimates complied from Industry reports *Factoring the advent of Biosimilar Insulins23 24. BIOSIMILARS PARTNERSHIP: MYLANMonoclonal Antibodies (MAbs) Combines Biocons R&D and manufacturing prowess of novel biologics/ bio-generics with Mylans regulatory &commercialization capabilities in the US and EuropeMarket size for product portfolio in 2010 : USD ~30 bn. Exclusive collaboration for development and commercialization of complex biogenerics and biosimilars.A basket of products with patents expiring between 2014-18. MAbs in particular. Mylan and Biocon to share development and capital costs.Mylan will have exclusive commercialization rights in the regulated markets;profits to be sharedBiocon and Mylan to have co-exclusive commercialization rights in other markets. 24 25. FINANCIAL HIGHLIGHTS 26. TOP LINE# & BOTTOM LINE# INR crore / USD mn FY08FY09FY10 FY11Revenue1090 2731194 260 14933181834 402EBITDA33583 372 81 455 97574 126Net profit22556 238 52 273 58340 74H1 FY12H1 FY11Revenue978 | 216837 | 182EBIDTA 282 | 62 255 | 55 29% 30%PAT156 | 34 147 | 32 16% 18%EPS7.8 7.35FY08-11: Avg.exch.rate in that fiscal ; H1 FY12: USD 1 = INR 45.35# 78% stake acquired in Axicorp GmBH in April 08.; fully divested as of March11 . Hence all figures are ex-Axicorp* Net profit is pre-exceptional in table 1.No exceptional items in FY10 and FY11..26 27. Thank You