Innovative Science Affordable Medicine

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1 Innvative Science Affrdable Medicine JP MORGAN HEALTHCARE CONFERENCE January 7,

2 Safe Harbr Certain statements in this release cncerning ur future grwth prspects are frward-lking statements, which are subject t a number f risks, uncertainties and assumptins that culd cause actual results t differ materially frm thse cntemplated in such frward-lking statements. Imprtant factrs that culd cause actual results t differ materially frm ur expectatins include, amngst thers general ecnmic and business cnditins in India, ur ability t successfully implement ur strategy, ur research and develpment effrts, ur grwth and expansin plans and technlgical changes, changes in the value f the Rupee and ther currencies, changes in the Indian and internatinal interest rates, change in laws and regulatins that apply t the Indian and glbal bitechnlgy and pharmaceuticals industries, increasing cmpetitin in and the cnditins f the Indian bitechnlgy and pharmaceuticals industries, changes in plitical cnditins in India and changes in the freign exchange cntrl regulatins in India. Neither the cmpany, nr its directrs and any f the affiliates have any bligatin t update r therwise revise any statements reflecting circumstances arising after this date r t reflect the ccurrence f underlying events, even if the underlying assumptins d nt cme t fruitin. 2

3 Agenda Glbal Pharma : Catalysts Bicn: Aligned With Trends Grwth Segments: Snapsht Financial Highlights 3

4 Glbal Pharma Catalysts: Emerging Markets Emerging Markets t cntribute ~ 75% f the Ttal Pharma Grwth by 2016 USD Bn Glbal Pharma Spending expected t crss $1.2 Trillin by 2016 ~70 ~180 ~1,205 Emerging Markets t grw > duble f Develped Markets ~955 Glbal Pharma Market Emerging Markets grwth driven by: Increased Gvernment Healthcare Spending Grwing Affluence ~ 5% CAGR 2011 A Develped Markets Emerging Markets 2016 E 4 Surce: IMS Glbal Medicines: Outlk 2016

5 Glbal Pharma Catalysts: Generics & Bisimilars Generics t grw 10 x f Branded drugs by 2016 Bisimilars will grw 5 fld t $5 Bn by 2016 ~1,205 USD Bn Bisimilars ~5 ~955 Generics 242 Small Mlecules ~ 241 Bisimilars ~ 1 Generics 430 Small Mlecules ~ 425 Branded* 713 Branded* E Surce: IMS Market Prgnsis, May 2012 *includes: OTC & thers 2011: ~$118 Bn: 2016 E:$145 Bn 5

6 Bicn: Aligned With Trends - Grwth Segments ANDAs & 505(b)(2) filings Small Mlecules Integrated fferings Research Services Grwth Segments Bisimilars (Bilgics & Insulins) Insulins, MAbs & Other Bilgics Unlck Value thrugh Licensing Nvel Mlecules Branded Frmulatins Rapidly grwing- India-centric business EMERGING MARKETS FOCUS 6

7 Grwth Segments: Snapsht

8 Grwth Segment: Small Mlecules APIs Frmulatins 505 (b) (2)s and ANDAs Leveraging existing APIs capabilities t frward integrate int: Branded Frmulatins fr Emerging Markets Generic Finished Dsages fr Develped Markets Differentiated ANDA strategy encmpassing ur fermentatin capabilities and mlecular cmplexity 25 mlecules identified fr ANDAs addressing a market pprtunity f ~$30 Bn ANDA Filing t cmmence in

9 Grwth Segment: Bisimilars Bisimilars Pipeline Prtfli Bisimilar Mlecule Prcess Develpment / Scale-up / Preclinical Phase 1/II b Phase III Market rh- Insulin Bisimilar Insulins Glargine Lispr & Aspart Bisimilar MAbs and ther bilgics Trastuzumab Bevacizumab, Adalimumab Etanercept, Peg-filgrastim Emerging Markets fcus thrugh Reginal Partnerships Prtfli Opprtunity Size* Bisimilar Insulins: $ 17 Bn Bisimilar MAbs & Other bilgics: $ 33 Bn *Market size f innvatr prducts 9

10 Grwth Segment: Bisimilars Bisimilar Insulin & Analgs Multiple reginal partnerships inked pst Pfizer Partnership discussins in prgress fr US & Eurpe Registratins: rh-insulin: 40+ cuntries Glargine: 5+ cuntries Greenfield expansin f ~ $200 Mn in Malaysia is n track Wrld class Delivery Device: INSUPen launched in Emerging Markets 10

11 Grwth Segment: Bisimilars Bisimilar Insulin & Analgs- Clinical Update Bisimilar rh-insulin EU Phase III cmpleted Results frm Part 1 f the study establishes the Efficacy end-pint (nn inferirity t innvatr prduct) Immungenicity and safety at the 6 mnth time interval als similar t innvatr; 12 mnths data awaited Market Authrizatin fr EU t be filed in FY 14 Bisimilar Insulin Glargine Glbal Phase I (PK-PD) study successfully cmpleted Established equivalence between bisimilar insulin glargine and the innvatr prduct Glbal Phase III t cmmence in 2013 Market Authrizatin t be filed in

12 Grwth Segment: Bisimilars Bisimilar MAbs & ther Bilgics: Prgram partnered with Mylan Cmbines Bicn's bilgics R&D and manufacturing with Mylan s regulatry & cmmercializatin capabilities Prgram Update Bisimilar Trastuzumab Glbal Phase III trial fr develped markets initiated ROW Fcused, Phase III trial underway in India First Filing in Emerging Markets expected in FY14 Other Mlecules Several Prgrams expected t enter the clinic in FY14 12

13 Grwth Segment: Nvel Mlecules Nvel Pipeline Therapeutic Area Mlecule Discvery Pre- Clinical Phase 1 Phase II Phase III Market Diabetes IN-105 Onclgy/ Autimmune Itlizumab # Onclgy Nimtuzumab Onclgy Anti CD 20 Onclgy Fusin Prteins Itlizumab: Marketing Authrizatin fr Psriasis apprved by the Indian drug regulatr Anti CD 20 (BVx 20) has entered the clinic in India Multiple Glbal Trials planned fr Oral Insulin in cllabratin with BMS # Phase 3 TREAT PLAQ study In India, Phase 2(b) glbally 13

14 Grwth Segment: Nvel Mlecules IN-105 (First-in-class Prandial Insulin) Optin Agreement with Redesigned Phase II trials under US IND fr Glbal develpment BMS will have an exclusive ptin pst phase II t further develp & cmmercialise the asset wrldwide Bicn t receive licensing fee in additin t regulatry & cmmercializatin milestnes 14

15 Grwth Segment: Nvel Mlecules Alzumab (Itlizumab- First-in-Class Anti CD6) Marketing Authrizatin fr Itlizumab (IV delivery) received frm Indian Drug regulatr fr Psriasis Alzumab India launch in nd Nvel Bilgic frm Bicn s repertire: First Nvel MAb fr Psriasis develped in India US IND t be filed in 2013 t facilitate glbal clinical trials in Psriasis, RA and ther indicatins as Sub Q First-in-Class Therapy :Nvel MOA with an excellent safety prfile Very lw Infectin rates vis-à-vis ther apprved therapies Prmising preclinical and clinical efficacy data in ther aut immune diseases (RA, MS) Partnership discussins initiated fr glbal develpment f this late stage pprtunity Baseline 12 Weeks 28 Weeks Treatment Arm 15

16 Grwth Segment: Branded Frmulatins Prtfli f 80 brands acrss 7 therapy segments USD Mn 100 Fcus n patient cnvenience, prduct differentiatin & persnalized medical supprt Several Bicn Brands in the Tp 3 52 Unique Prduct Offerings: BiMAb EGFR: India s first indigenusly develped nvel bilgic Insugen: #1 Indian Insulin Brand FY 10 FY 11 FY 12 FY 14 P 16 Exchange Rate :1 USD= Rs. 50

17 Grwth Segment: Branded Frmulatins Differentiated Prtfli Unique Mix f Nvels, Bisimilars and Branded generics Cnsistent Grwth Fastest grwing Insulins Cmpany in India at 33% YY Grwth CAGR in excess f 30% vis-à-vis an industry average f 15% ver 4 years Recgnized as a leading Onclgy cmpany in India Mving Ahead Prtfli Expansin with Nvels & Differentiated generics Grwing beynd India: Gegraphical Expansin int Emerging Markets 17

18 Grwth Segment: Research Services Integrated Platfrms Integrated Drug Discvery and Develpment Bilgics Discvery and Develpment Syngene- Clinigene axis Niche Services Bianalytical testing f small and large mlecules Antibdy Drug Cnjugate (ADC) develpment Unique In-Viv Mdels- Human tumr tissue Xengraft Early and rapid txiclgy evaluatin (Cardimycytes ) Evlutin f Services Cmmercial scale prductin f NCEs High ptency (cyttxic) API manufacturing Frmulatin develpment Differentiated Business Mdels Dedicated/custmized infrastructure End-t-end services Risk sharing: Milestne based Incubatin: IP sharing 18

19 Grwth Segment: Research Services USD Mn 82 PE Investment f $ 25 Mn fr a 7.7% stake, valuing Syngene at $ 325 Mn 64 Investment aimed at enhancing Syngene s service fferings & fund future grwth 56 Dedicated, India-centric nutritin R&D Centre Fcused n: Maternal & Child Nutritin Diabetes Care FY 10 FY 11 FY Exchange Rate : 1 USD= Rs. 50

20 Financial Highlights

21 Revenue FY 09 - FY USD Mn Strng Tp Line Grwth 3 year CAGR :22% FY09 FY10 FY 11 FY12 Exchange Rate :1 USD= Rs. 50

22 Financial Perfrmance : H1 FY13 USD Mn H1 FY13 H1 FY12 Revenue R&D Expenses % 5% EBITDA % 28% PAT % 16% EPS Grwth Drivers in H1 - FY13* APIs & Bisimilar Insulins: 21% Branded Frmulatins: 45% Research Services: 40% Strng Balance Sheet Sharehlder Funds: $490Mn Net Cash Psitin: $125 Mn Exchange Rate :1 USD= Rs *Abslute Grwth rates n a YY basis

23 Leveraging Challenges fr Sustained Grwth 25% 20% FY 18 E $1 Billin + 20% 10% 25% FY 15 E $700 Mn 20% 5% 30% 5% Small Mlecules FY 12 A ~ $450 Mn 40% Bisimilars (Insulins + MAbs) Research Services Branded Frmulatin Nvel Mlecules /Licensing 23

24 Lking Ahead Reaching $700 Mn by 2015 Small Mlecules - Imprved prduct Mix: $280 Mn 25% Research Services - Sustained Grwth Mmentum : $175 Mn FY 15 E 20% Branded Frmulatins - Differentiated Value fferings :$140 Mn Bisimilars - Gegraphical Expansin :$70 Mn 10% ~$700 Mn 5% Nvel Mlecules - Out-licensing and Glbal Develpment :$35 Mn 40% 24

25 Innvative Science Affrdable Medicine Thank Yu