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Ranbaxy Laboratories Limited. Merrill Lynch 12 th India Investor Conference New Delhi , February 2008. Safe Harbor.
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Ranbaxy Laboratories Limited Merrill Lynch 12th India Investor Conference New Delhi , February 2008
Safe Harbor Except for the historical information contained herein, statements in this presentation and the subsequent discussions, which include words or phrases such as “will”, “aim”, “will likely result”, “would”, “believe”, “may”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”, “contemplate”, “seek to”, “future”, “objective”, “goal”, “likely”, “project”, “should”, “potential”, “will pursue” and similar expressions or variations of such expressions may constitute "forward-looking statements". These forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to our ability to successfully implement our strategy, our growth and expansion plans, obtain regulatory approvals, our provisioning policies, technological changes, investment and business income, cash flow projections, our exposure to market risks as well as other risks. Ranbaxy does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date thereof.
Mission Statement “ To become a Research based International Pharmaceutical Company ”
Ranbaxy Overview • Amongst top 10 Global Generic companies (CY ’07 sales ~ $1.6 Bn, +20%) • Largest pharmaceutical Company out of India • Worldwide Presence - Ground operations in 49 countries, products sold in > 125 - Manufacturing locations in 11 countries comprising 25 facilities • Business - International - 80% - Domestic - 20% • ~12000 employees globally spanning 51 nationalities
Business Model Global Reach Product Portfolio • Generics • Branded Generics • Branded & OTC • Developed Markets • North America, EU, Japan • Emerging markets • India, Romania, CIS, Africa Research & Dev. Manufacturing • New Chemical Entities • Generics / NDDS* • Complex / Niche/ FTF* • The India advantage • Dosage Form • API* - Vertical Integration • In-house / Outsource • The India advantage * NDDS - Novel Drug Delivery System, API – Active Pharmaceutical Ingredients, FTF – First to File
Active Pharmaceuticals Ingredients (APIs)Facility, Mohali Global Manufacturing • API facilities in India - 6, API - 5,Fermentation - 1 • Global Dosage Forms (DF) facilities - 19, India - 6, Overseas - 13 USA Romania Malaysia Ireland Nigeria China Vietnam India + South Africa, Japan and Brazil
Research & Development • Dedicated Facilities for Innovative & Generics Research • > 1400 R&D Personnel ( ~ 250 PhD’s) • 8-10 NCE molecules in pipeline • 4 NDDS platform technologies • ~ $ 100 Mn total spend (6.4% to sales) Collaboration in Drug Discovery Research (DDR) R&D I R&D II Out-licensing in DDR Out-licensing in Novel Drug Delivery Systems R&D III R&D IV
Global Sales (2005 - 2008e) CAGR* ~ 19% $ Mn ~ 1900 e * 3 year CAGR on like-to-like basis .i.e. excluding allied businesses divested in 2005 e - estimate
Highlights – Year 2007 • Buoyant base business growth in USA, + 19% • Strong performance across EU, + 41% • Emerging markets continue robust growth, + 32% Markets • 180 Day exclusivity products (FTF) for USA • Specialty product flow - bio-generics, oncology, etc • Research & Development - NCE focus Key Value Drivers • Sales at $ 1607 Mn, + 20% • EBIDTA* at 16.5% to sales • PAT** at $ 147 Mn, + 28% Financials * Excludes impact of foreign exchange gains / losses on translation. ** and extra-ordinary items
USA • 24% of global sales, base business growth (excl. FTF) +19% • Distribution coverage with all major wholesalers & and retail chains • Branded business growth + 37% - Sotret gains market leadership ~ 51% MS - Acquisition of BMS portfolio to further strengthen dermatology franchise • Robust product flow with assured visibility on FTF products from ’08-10 • - Sumatriptan - 2008, Valacyclovir - 2009, Atorvastatin & Tamsulosin - 2010 • - Atleast 1 potential FTF launch anticipated from 2008 to 2012/13 Note : Anticipated FTF launches depending on regulatory approval & litigation outcome, where applicable
USA – Product Pipeline Innovator Market Size Cumulative ANDA Filings 98 ANDAs • 239 cumulative filings • 141 approvals • 98 pending approvals • 18 Para IV First to File Para IV FTF $ 27 Bn $ 54 Bn • Yr 2007 – 28 filings & 18 approvals Source (Market Size) : IMS
European Union • Presence in 23 of the 27 EU countries • Strong product flow in ’07 with multiple Day 1’s Key Country Sales - 2007 Total EU Sales - 2007 Romania $ 363 $ 120 Mn, + 21% + 41% France $ 258 $ 73 Mn, + 5% Germany $ 49 Mn, + 69% UK $ 47 Mn, + 36% $ Mn
India • Ranked in No 2 in domestic market with a 5.04% MS(Source :ORG-IMS, QTD Nov ) • Sales at $ 338 Mn, + 23 % (including CHC) • Leadership in NDDS products with 7% MS. Contribution to total sales ~ 9% • Dedicated task forces for Specialized & Chronic therapies Chronic share contribution at 24% (21% : IMS Cum Nov ’06) • 18 brands in Top 300 of Industry, 9 in Top 100 • Robust Consumer Healthcare business led by flagship brand ‘ Revital’ Source : IMS - ORG
Key Value Drivers Emerging Market / Developed Market Mix 180 Day Exclusivity Products in USA Enhanced Focus on NCE Research Specialty Therapeutic Segment Presence
Market Mix 2005 2007 • Growth well spread across geographies • Stability & sustainability of profits
180 Day Exclusivity Products (USA) At-least 1 FTF launch planned each year upto 2012 / 2013 *FTF for the 80 mg dosage strength respectively. Market sizes at innovator prices (Source :IMS). BI – Boehringer Ingelheim. Anticipated FTF launches depending on regulatory approval & litigation outcome, where applicable
Specialty Segment Presence • Leveraging front end presence & regulatory expertise • Technology & Resource intensive – high entry barriers Alliances In-House • Bio-generics • Peptides • Oncology & Specialty • Injectables • Penems • Limuses • Oral High Potency • Non-cytotoxics
Enhanced Focus on NCE Research • In-principle approval from the Board for de-merger of Drug Discovery Research (DDR) • To create an independent pathway for DDR with dedicated resources and enhanced focus for long term value building • Provides platform for new growth opportunities through increased collaborations and partnerships • Specific framework & other details under finalization
NCE Pipeline Molecule Therapeutic Area Status RBx 11160 Phase II trials (with Piperaquine) have been initiated in Q4 2007 Malaria RBx 10558 Dyslipidemia Out-licensed to PPD Inc. 1Phase I trials completed RBx 9841 Urinary Incontinence Phase I trials completed Candidate Selection GSK Program - COPD / Asthma RBx 10017876- Inhalation PDE IV B, COPD/Asthma RBx 10020025- Tiotropium like , MRA inh, COPD/Asthma RBx 10014255- Anti infective, Macrolide / Ketolide RBx 10019821- Diabetes, DPP IV
Ranbaxy – GSK Alliance • Expansion of strategic alliance established in 2003 • Take leads beyond candidate selection to POC* in man • Therapeutic area focus of AI & Metabolic, Respiratory & Oncology • > $ 100 Mn in milestone and double digit royalties on commercialization of a product • Co- marketing rights in India • First candidate identified for Respiratory Inflammation * Proof of Concept
Financials $ Mn * Excludes impact of foreign exchange gains / losses on translation ** Excludes impact of foreign exchange gains / losses on translation & extraordinary items
Summary • A vertically integrated global pharmaceutical Company • Presence across all key developed & emerging markets • Strong distribution network & brand building capabilities • India based Research & Development & Manufacturing • Robust generic product flow • New high growth specialty segments • Focus on NCE research
Thank You … Merrill Lynch 12th India Investor Conference New Delhi , February 2008