- 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
