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Investor Presentation May 2006 LUPIN
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Safe Harbour Statement Materials and information provided during this presentation may contain ‘forward-looking statements’. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements. Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions such as interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited, to technological advances and patents attained by competitors, challenges inherent in new product development, including completion of clinical trials; claims and concerns about product safety and efficacy; obtaining regulatory approvals; domestic and foreign healthcare reforms; trends toward managed care and healthcare cost containment, and governmental laws and regulations affecting domestic and foreign operations. Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are not limited, to inability to build production capacity to meet demand, unavailability of raw materials, and failure to gain market acceptance. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
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Agenda –Global Pharmaceutical Industry Overview –Indian Pharmaceutical Industry –Lupin -Business Update –2006-07 and Beyond
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Lupin Limited
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Vision To be an Innovation led Transnational Pharmaceutical Company Values Superior Performance Entrepreneurship Customer Orientation Working Together Respect for People Integrity
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Pharmaceutical Industry Overview
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Global Pharmaceutical Industry Overview Global Pharmaceutical market at US$600 billion market in 2005 Market expected to grow at a rate of 6-7% Ten major markets account for almost 81% of the market in terms of revenue North America is the single largest market accounting for approx. 50% of global sales and is expected to grow at a CAGR of 5-8% Japan, the second largest market, at US$60bn is growing at 6% EU experiencing growth at 7% at US$ 170bn Growing importance of generics in regulated markets Pressure from healthcare providers and insurance companies to reduce healthcare costs driving usage of generic drugs Increasing patent expirations driving generic drug availability Stringent testing requirements and declining R&D productivity has led to limited new drug pipeline 4
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Indian Pharma – Emerging Scenario DOMESTIC FORMULATIONS IPR Regime Pricing pressure on ‘older’ molecules Brands/ differentiated products Likely to witness higher growth In Licensing GENERICS BUSINESS Increasing competitive landscape Pricing pressure Aggressive build up of products Acquisitions US$ 60 bn opportunity CONTRACT MANUFACTURING JV/ Alliances Competition from China INDIGENOUS R&D ANDA/NDDS/NCE Out Licensing High Investment/ Long gestation Indian Pharma Domestic Market: US$ 5bnExports: US$ 2.5bnTotal: US$ 7.5bn
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Lupin Strives For: Sustainable Earnings Accelerated Growth Fulfilling Stakeholder Aspirations
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Regulated Markets (US): Lupin Approach LUPIN Generics Para III Specialty Para IV Complex Generics Branded Generics Lisinopril… Ramipril… Ceftriaxone... NCE/ NDDS Suprax… Other Regulated Markets : Focus on Branded Products Partnerships & Alliances
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Developing Markets : Lupin Approach Rural IRF/ CIS/ AAME/ LA Specialty Post 2005 In-licensing Ceff-ER, Odoxil OD, … Lupinova NDDS LUPIN Global Tenders GTB Enoxaparin Sodium… Branded Generics Urban
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Advanced Markets
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US Branded: Suprax continues its prescription growth: over 5000Rx per week Sales force internalised Copromotion of Atopiclair with Chester Valley New Products in 2006-07 Generics: 7 products launched in the US in 2005-06 Timely launch of Ceftriaxone and Cefprozil immediately on expiry Launched Lisinopril in Dec05: Consolidating Market share Commenced Direct Marketing (DTM) in Dec05 18 ANDAs filed taking total ANDAs to over 35
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Generics US Target Therapies Mkt sizeLupin $ billionNo. of productsLaunched till now Cephalosporins2107 CVS25151 CNS1511- Anti-ulcer134- Macrolides22- Others33- Total60458
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Other Markets Europe: Ramping up MAA/ Dossier filings Alliances in progress Revenues commenced Expressions of interest at advanced stages Japan, Australia & LA: Expressions of interest moving forward MDR-TB sales commenced in LA South Africa: JV with Aspen (Anti-TB FDC) for Africa
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Robust pipeline CountrySubmissions during the year Total submissions US1837 EU911 France22 Australia/ NZ911 RoW3461107
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India Region
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India Region Formulations Growing at 24% vs 8% industry average Contributed by CVS (57%), NSAIDS (38%) and Diabetology (174%) Anti-Asthma range launched in Aug 04, already number 2 in its segment and growing (126%) Signoflam (Endeavour), the best product launch (IMS Data) of the year in the industry Lupinova driving foray into rural and less penetrated regions Top 10 brands Odoxil341R-Cinex316 AKT – 4236Cefaxone185 Ceff166Tonact148 AkuriT – 4147L-Cin*127 R- Cin121Ramistar119 Rs. Mn ORG-MAT JAN 06*introduced in last 3 years
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Other Markets CIS: Posted a healthy growth – CAGR of 44% over last 4 years Expanding Field Force – Russia, Ukraine, Azerbaijan, Kazakhstan, Uzbekistan Increased market penetration Around 20 Products Registered in each; around 10 under Registration SE Asia: Alliance with GSK Middle East: Will be shared as Alliances progress Africa: Alliance with Ranbaxy GTB: Posted a healthy growth – 122%
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API & Intermediates
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Sales : 11% growth Ceftriaxone launched in US Focus on Cost & Quality Leadership and Reliability Long Term Supply Contracts Global Leadership in areas of therapeutic presence Future expansion only at SEZs
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Global Position in API & Intermediates 1 Cephalosporin - Intermediate 7ADCA 1CardiovascularLisinopril 2 Cephalosporin - Intermediate 7ACCA 1Anti-TBPyrazinamide 1Anti-TBRifampicin 1Anti-TBEthambutol Global Rank Therapeutic SegmentProduct Two new products in 2006-07
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Research & Development
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R&D at Lupin Over 300 scientists –Actively engaged in: Process Improvement/ Formulation Development/NCE/ NDDS Expenditure: Rs.1030mn – 6.2% of Sales –Continue investing incrementally Filings in last year –US: ANDAs: 18 –EU: MAAs: 11 –ANZ: Dossiers: 9 –Other: Dossiers: 346 –DMFs/EDMFs/COS:41 Going Forward –NDDS –Paediatrics range –Patented Technology platforms –Products for paediatric pipeline
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R&D at Lupin NCEs –Anti Psoriasis (Herbal) - In Phase II –Anti Migraine- In Phase II –Anti Psoriasis (Chemical)- Entering Phase II –Anti TB- In Phase I
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Patents Patents Issued, Allowed & Pending 302 Issued, Allowed 71 Pending 231 US 14 EU RoW 47 EU 10 US 31 EU 18 RoW 182
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Business Update
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2005-06 34% 40% 37% (Rs Mn) Sales Growth Revenue Composition
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2005-06 Revenue Growth : 37% EBITDA margin : 18% PBT : 14% PAT : 11% ROCE : 22% 106% (Rs Mn) Profit Growth 116%
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2004-05 Geographical Coverage 2005-06
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2004-05 API vs FD 2005-06
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Lupin’s Facilities Manufacturing Research Center Goa Pune Tarapur Ankleshwar Mandideep Aurangabad Jammu LOCATIONPRODUCTSAPPROVALS Mandideep, Madhya Pradesh Cephalosporins Prils USFDA, UK MHRA, TGA USFDA Tarapur, Maharashtra Rifampicin Lovastatin USFDA, UK MHRA - Ankleshwar, Gujarat Ethambutol Intermediates USFDA Aurangabad, Maharashtra Rifampicin Pyrazinamide Ethambutol Lisinopril WHO, MCC (South Africa) Verna, Goa Non- cephalosporin Oral Formulations USFDA, UK MHRA Jammu, J&K Formulations- Pune, Maharashtra R&D Mumbai, Maharashtra Head Office Mumbai
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Year 2006-07 and Beyond
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Lupin Going Forward New Markets/ Initiatives: Enter Advanced Markets EU Japan Australia South Africa Establish On-shore presence in 5 select markets Acquisition: Brands in US Businesses in select countries of EU Domestic
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Lupin Going Forward Explore New Therapies/ Business Segments: Therapeutic Areas Oncology Dermatology Business Segments Biosimilars CRAMS
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Thank you
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