2. SAFE HARBOR
Certain statements in this release 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. AGENDA
BIOCON SNAPSHOT
BRANDED FORMULATIONS
STRATEGIC ALLIANCES
RESEARCH & DEVELOPMENT
FINANCIAL HIGHLIGHTS
3
5. 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
5
6. BUSINESS STRUCTURE & HOLDINGS
Biocon Research , India | 100%
R&D- Novel Molecules
Biocon Biopharmaceuticals | 100%
Mabs and Biosimilars
~61% | Promoters
Biocon Sdn. Bhd, Malaysia | 100% PRODUCTS
~ 7 % | Employees & ESOP trust Biocon Overseas subsidiary
~32 % | 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 development
6
7. A PORTFOLIO BASED APPROACH
Insulins &
Other Branded Research Novel
Statins Immuno
Biopharma Formulations Services Molecules
Suppressants
Portfolio Constituents
Statins Simvastatin, Atorvastatin, Lovastatin, Rosuvastatin, Fluvastatin & Pravastatin
Insulins & Insulin, Glargine & 2 Analogs (under development)
Immuno suppressants Tacrolimus, MMF & MPA
Other Biopharma Orlistat, Fidaxomicin, 50+ other molecules
Branded Formulations Diabetology, Cardiology, Nephrology, Oncology, Immunotherapy, Comprehensive Care
Research Services Syngene (Custom Research)
Clinigene (Clinical research)
Novel Molecules IN-105, Itolizumab and others 7
8. A RISK BALANCED GROWTH STRATEGY
Small
Molecules
Research Biosimilars
Services (Biologics &
Growth Insulins)
Verticals
Novel Branded
Molecules Formulations
EMERGING MARKETS FOCUS
EMERGING MARKETS FOCUS 8
12. BRANDED FORMULATIONS : PRODUCTS & MARKETS
INDIA PRODUCT RANKINGS*
Cardiology
Myokinase 2
Oncotherapeutics
BioMAb EGFR 2
Abraxane 3
Immunotherapy
Tbis 2
Picon 2
* November MAT 2011
12
13. BIOCONâS INSULIN BUSINESS (INDIA)
MAT November 2011 YoY
Bioconâs ranking Bioconâs market share by
growth for value sales of 40
volume:
IU insulin:
#4 in overall insulin Market: 18% 40 IU Insulin: 11%
#3 in the 40 IU Insulin market 36%
Biocon:
Glargine vials: 68%
#1 in the Glargine vial market Novo Nordisk: 18%
Source: IMS Health â MAT, November 2011
10 players in
Biocon has the insulin
both OADs space
and insulins
60 of these are in the oral
anti-diabetics space
63 players operate in the
anti-diabetics market
13
14. BRANDED FORMULATIONS : INSUPenÂź ease LAUNCH
Designed for accuracy, efficiency, safety & economy.
âą Launched in October, 2011
âą Based on proprietary German
technology
âą Reusable delivery device capable
of delivering both InsugenTM &
BasalogTM
âą âOne Call Does Allâ Support
helpline
Expected to add further impetus to branded formulationsâ sales in H2FY12
14
17. BIOSIMILARS COMMERCIALIZATION PARTNERSHIP: PFIZER
Insulin and Insulin analogs
Combines Biocon's research and manufacturing
capabilities with Pfizer's global marketing prowess
Global agreement for commercialization of Biocon's biosimilar versions of
Insulin & 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.
17
18. Diabetes Prevalence (% of population)
Diabetics (absolute nos. )
Source: International Diabetes Atlas 2011
18
19. BIOSIMILARS: GLOBAL OPPORTUNITY
Total 2010 Insulin Market USD ~15 Bn Total 2010 Biologics Market* USD ~138 Bn
rh insulin Bioconâ s
21% Target
Opportunity
Lispro
14%
Glargine
32% detemir
8%
Aspart glulisine
2%
23%
Expected to be USD ~20 Bn in 2020 Expected to be USD ~200 Bn in 2015
* Biologics Includes MAbs, Vaccines, Growth Factors
Source: Industry reports, IMS data 19
20. BIOSIMILARS COMMERCIALIZATION PARTNERSHIP: MYLAN
Monoclonal Antibodies (MAbs)
Combines Biocon's R&D and manufacturing prowess of
novel biologics/ bio-generics with Mylanâs regulatory &
commercialization capabilities in the US and Europe
Market 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 shared
Biocon and Mylan to have co-exclusive commercialization rights in other markets.
20
22. RESEARCH PARTNERSHIPS : HIGH POTENTIAL PRODUCT PIPELINE
ï US IND filed by partner (Amylin) for AC165198
ï Several Bi-specific fusion proteins under development with IATRICa
* Including molecules from collaborative programs 22
23. ANTI-CD6 MAb: Itolizumab
Drug Highlights
Targets CD6
CD6 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 223
Trial Duration 52 Weeks
Interim Data Presented 28 Weeks
23
24. TREAT PLAQ STUDY: SUMMARY OF RESULTS#
PRIMARY ENDPOINT Result*
Statistically significant patient cohort with â„ PASI 75 at 12 Weeks ï
SECONDARY ENDPOINTS
Significant Proportion of subjects achieving PASI 50 and PASI 90 ï
Safety & Tolerability ï
Improvement in PGA scores ï
Considerable Proportion of subjects with PGA score of âclearâ or âminimalâ ï
PASI: Psoriasis Area Severity Index PGA: Physicians Global Assessment *p <0.05
Results of Interim 28 Week data 24
25. TREAT PLAQ STUDY : EFFICACY RESULTS
Representative patient samples from each arm.
Week Baseline 12 Weeks 28 Weeks
Trial Arm
Induction
Dose Arm
Fixed Dose
Arm
Placebo Arm
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26. TREAT PLAQ STUDY: OVERALL CONCLUSIONS
ï First in class therapy, with a novel MOA, novel target and an
excellent safety profile
ï Successfully achieved primary endpoint of PASI-75 at 12 weeks
with continued improvement in efficacy over time
ï Very low infection rates observed compared to reported rates
from other approved therapies (~10% compared to ~30%)
ï Promising preclinical and clinical efficacy data in other auto-
immune indications (RA, MS)
Planned Initiation of Phase 2 double blind trial in RA
26
27. ORAL INSULIN IN-105
Drug Highlights
Conjugated peptide
Lower 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 with
basal insulins.
Proof of Concept : Stable tablet formulation.
Established oral delivery
27
28. IN-105 INDIA PHASE III RESULT SUMMARY
SECONDARY END POINTS
Efficacy â Secondary Endpoints
Statistically significant reduction in PPG during STM ï
Significant reduction in SMBG post prandial glucose excursion ï
Safety â Secondary Endpoints
No clinically significant hypoglycemia ï
Very low immunogenicity ï
No neutralizing antibodies detected ï
No effect on liver enzymes ï
No effect on lipid profiles ï
No effect on renal function ï
Efficacy â Primary Endpoint
Change in Hb1Ac for IN-105 not statistically significant X
due to higher than anticipated placebo effect 28