Ranbaxy Laboratories Limited To become a Research based International Pharmaceutical Company UBS Global Generic and Specialty Pharmaceuticals Conference New York May 8, 2007
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.
Key Drivers of Growth Significant patent expiries through 2011 Rationalizing Healthcare costs - key priority for Governments Increasing genericisation FranceSpainItaly RussiaSouth AfricaIndia $ Bn Value of Drugs going off patent Source : IMS Accelerating branded generics
Key Issues Increasing competition Increasing focus on costs
Consolidation - Changing Landscape Source: UBS, Business World, 30 th October 2006
The India Pharma Story – Davos 2006 Source – Financial Times
Scientific Manpower Output Number of Higher Education Institutions 05/06 18, % 00/01 11,412 90/01 5,932 80/01 4,861 Source: Indian University Grants Commission Number of Students enrolled in Higher Education Institutions 05/06 10, % 00/01 7,500 90/01 4,000 80/01 3,000 Source: Indian University Grants Commission Number of Institutions courses 05/06 99/00 Pharmacy % Medicine % Physiotherapy % Source: Pavan Agarwal (2006) based on data from professional councils PhD Degree awarded in Science 03/ % 00/ / (USA 03/04 25,000) Source: Indian University Grants Committee
The Education Advantage Engineers/Science graduates p.a. – India 0.7 mn, China 0.5 mn, EU 0.5 mn, USA 0.4 mn, Japan 0.3 mn
India in Global Generics % Share of USA DMF filings India China % 9% % 10% % 14% Q4’06 47% 9% Source: US FDA / J P Morgan Research FDA Approved Plants in India Highest No of DMF filings
ANDA Filings in USA by Indian Companies One in every four ANDAs filed by Indian Companies in top US FDA filers (Source: KPMG) No Chinese generic company has yet filed a US FDA ANDA but expected in 2008 India in Global Generics
Ranbaxy Today Amongst Top 10 Global Gx companies Ground presence in 49 countries, products sold in > 125 International business ~ 80% of sales Manufacturing locations in 11 countries > 11,000 employees, 51 nationalities Strong Generics & Innovative research capabilities $ 553 $ 972 $ 1339 CAGR 19 % Global Sales Worldwide Presence
Highlights Financials Markets ^ % Sales % EBIDTA*16%7%- PAT % * % sales, ^ excludes sales from discontinued operations.i.e. Allied Businesses divested in 2005 Strong growth in USA Leadership position in home market Robust performance in Branded Gx markets Exclusivity in Simvastatin 80 mg tablets Inorganic impetus $ Mn
Increasing Focus on Costs * Estimate, ^ Bio-Analytical / Bio - Equivalence * Increasing sourcing from low cost countries.i.e. India & China Improving R&D cost efficiencies Optimizing SG&A cost structures 65% 80% 35% 20% In-House71%28% Overseas CRO8%61% Indian CRO21%11% % Bio-Studies (BA/BE ^ ) conducted Sales growth +17% SGA growth - Nil Advanced MarketsLow Cost Countries
Geographic Sales Split * Including CIS, RoW – Rest of the World Global Sales – 2006 (US$ Mn) DF % API115- 9% Total % Sales 2006 – Dosage Forms US$ 1224 Mn Key New Markets – Canada, Spain, Italy, Australia & Japan 33% 25% 27% 6%
Geographic Sales Split – Q * Including CIS, RoW – Rest of the World Global Sales – Q (US$ Mn) DF332+30% API23- 25% Total % Sales Q – Dosage Forms US$ 332 Mn 29% 31% 27% 7%
USA Strong growth in USA, +15% Simvastatin 80 mg 180 day exclusivity - Market Share (MS) of 56% Increasing No of Prescriptions - Q Mn - Q Mn - Q Mn Cumulative chain store listings at 1057 (44 added in Q1 ’07) Branded business growth at 20% +15% $ 332 $ 380 Source (Market Share) : IMS Sales
USA Product Pipeline 199 cumulative filings 111 approvals 88 pending approval ~ 20 FTF ANDAs Cumulative ANDA Filings Source (Market Size) : IMS filings - 10 approvals Innovator Market Size - 88 ANDAs – US$ 56 Bn - 20 FTF – US$ 26 Bn
USA Products pending approval Source: Merrill Lynch Equity Research, February 2007 # of ANDAs Second largest pipeline
Potential FTF Challenges # of FTFs Second largest FTF pipeline Source: Merrill Lynch Equity Research, February 2007 USA
European Union Presence in 23 of the 27 EU countries Regulatory changes & price impacted Western European markets Strong product flow in ’07 with multiple Day 1’s Major countries - Germany : AOK business - France : Supplies from India - UK : Gabapentin launch RoE to maintain growth momentum Sales $ 267 $ 214 $ Mn Romania
India Fastest growing Company in India on MAT basis (Source :ORG-IMS Mat Mar 2007) 65 new products introduced in 2006 No 1 NDDS Company with 8% MS. Contribution to total sales ~ 9% Dedicated task forces for Specialized & Chronic therapies Chronic share contribution at 21% (2005 : 20%) 21 brands in Top 300 of Industry ( 2005 :19) First to market10 NDDS6 In-licensed8 Source : ORG – IMS Audit Nov 2006, Moving Quarter Basis GSK Cipla Ranbaxy 5.0% 4.9% 5.1% Source : IMS - ORG
Research & Development New R&D facility for Drug Discovery Research (DDR) R&D I R&D III R&D II R&D IV
Research & Development Dedicated Facilities for Innovative & Generics Research > 1400 R&D Personnel ( ~ 250 PhD’s) NCE molecules in pipeline NDDS based products ( 4 platform technologies) R&D collaborations Alliance / Collaboration in DDR Out-licensing in NDDS Out-licensing in DDR
Ranbaxy – GSK Collaboration Expansion of strategic alliance established in 2003 Take leads beyond candidate selection to POC* in man Therapeutic area focus of AI, Metabolic, Anti-inflammatory and Oncology > US$ 100 mn in milestone payments and double digit royalties on commercialization of a product Co- marketing rights in India First candidate identified for Respiratory Inflammation Proof of Concept
Ranbaxy – NCE Pipeline RBx (Malaria) Agreement for part funding by DST* MoleculeStatusRemarks Under Phase II B trials (with Piperaquine) RBx (Dyslipidemia) Out-licensed to PPD Inc. IND approval received from DCGI* (India) in May ‘06 RBx 9841 (Urinary Incontinence) Out-licensing opportunity being explored Phase I trials Candidate Selection GSK Program - COPD / Asthma RBx Inhalation PDE IV B, COPD/ Asthma RBx Tiotropium like, MRA inh., COPD / Asthma RBx Diabetes, DPP IV RBx Anti infective, Macrolide / Ketolide 5 molecules under lead optimization including 1 with GSK * Department of Science & Technology, Drug Controller General of India
Ranbaxy – NCE Progress Department of Science & Technology (DST) part funding on 3 molecules Scientific Advisory Board comprising 6 globally renowned scientists GSK – 1 milestone triggered Therapeutic Focus - - Anti-infectives (Malaria) - Anti-inflammatory (COPD/ Asthma) - Metabolic diseases (Diabetes) - Oncology Unprecedented : Precedented targets ratio – 40:60
Generic Research & Development 27 ANDA filings in USA 33 Filings in the European Union Key Country / RegionFilingsApprovalsFilingsApprovals USA European Union BRICS Rest of World Total Dosage Forms API Excludes India for API approvals, EU filings and approvals include Mutual Recognition Procedure (MRP) and De-centralized Procedure (DCP) filings and approvals Product Filings & Approvals
Recent Acquisitions & Alliances Terapia (Romania) Be-Tabs (South Africa) Allen (Italy) Ethimed (Belgium) Mundogen (Spain) Zenotech (India) Krebs (India) Jupiter Biosciences *(Ind.) Cardinal Drugs (India) Auto-injector Tech.(USA) * Subject to due diligence
Niche Alliances Increasing focus on chronic / lifestyle diseases segment High entry barriers - technology & resource intensive Fermentation based products Bio-similars & Oncologics Peptides Krebs ZenotechJupiter* * Subject to due diligence
Enhancing In-house Technologies Penems Limuses Oral High Potency Non-cytotoxics Market size worldwide of ~ US$ 1.5 bn Imipenem + Cilastatin launched in India, China, Africa, APAC Key US / EU launches beginning 2009 Global market size in excess of US$ 1.5 bn Ex - US / EU launches beginning 2008 Well placed for US / EU launches Worldwide market in excess of US$ 5 bn Patents expiring from 2008 onwards Day 1 launches planned for US / EU
Financials Particulars Sales EBITDA % sales OPBT* PBT PAT * 2005 sales excludes sales from discontinued operations.i.e Allied Businesses. OPBT – Operating profit before tax Figures in US$ Mn Q1 2007% 35524% 43 12% 35% 36102% 3794% 2981% 2006% % % 144% % % 11490%
In Summary A strong 2006 performance on all parameters Buoyant performance across key geographies Continuing focus on cost optimization Robust product flow Growth through organic & inorganic Discovery pipeline progressing well Global Generic rank – 9th / 10th
Thank You … Ranbaxy at the UBS Global Generic and Specialty Pharmaceuticals Conference New York May 8, 2007