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Investor Presentation. November 2005. 1. Safe Harbour Statement.
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Investor Presentation November 2005 1
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. 2
Agenda • Pharmaceutical Industry Overview • Lupin – A Differentiated Business Model • Financial Overview • Business Strategy and Investment Highlights 3
CAGR – 13.7% Global Pharmaceutical Industry Overview • Estimated to be a US$550 billion market in 2004 (including estimated unaudited pharmaceutical sales) • Market expected to grow at a rate of 7% to 9% • Regulated markets account for almost 90% 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 10% • EU was the fastest growing market, growing at a CAGR of 26% in the period 2002 – 2004 Global Pharmaceutical Sales* Emerging Trends • 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 • Legislative changes such as the enactment of the Hatch-Waxman act and changes to the Medicare Act in the US providing a major boost • Stringent testing requirements and declining R&D productivity has led to limited new drug pipeline • Increasing pressure on big pharmaceutical companies to enhance new drug pipeline Source: IMS World Review (Industry Sales based on Audited Numbers) Key Generic Drug Markets The generic drugs market which is expected to grow at 10%-12% over the next few years is a key growth area for emerging pharmaceutical manufacturers 4
Factors driving the Indian Pharmaceutical Industry Generic Exports and API Outsourcing Indian Pharmaceutical Market Overview India is well positioned to target generic exports and API outsourcing opportunities in the regulated markets • Skilled work force with strong chemistry skills • Significant and sustainable cost advantage over international peers • Good understanding of the regulatory framework • India has largest number of US FDA approved plants outside the US • Largest number of DMF filings outside US • Indian companies are among the leading players participating in Para IV challenges • Approximately US$5 bn in 2004 with exports accounting for an additional US$2.5 bn • Amongst top 4 markets by volume globally • Strong branded generics market • Market growing at a rate 6%-8% as a result of growing awareness, increasing penetration & increasing affordability • Emerging segments such as CNS, diabetes etc. growing at 15-20% + • Introduction of product patents in India in 2005 are expected to lead to a greater emphasis on drug discovery and development Growth Opportunities R&D Outsourcing • Skilled work force at competitive costs • Significant progress in development of pharma & R&D infrastructure over last 5 years • Focus on early stage processes for NCEs, NDDS, clinical trials, process re-engineering and dedicated manufacturing A combination of strong chemistry skills, regulatory capabilities and quality manufacturing has positioned India favorably to capitalize on the global pharmaceutical opportunity 5
Business Overview Therapeutic Mix - FY 2005 • Among the top 6 pharmaceutical companies in India • Leading global player in anti-TB & Cephalosporins • Strong position in prils and emerging global player in statins • Globally accredited manufacturing facilities • Strong R&D Focus • 14 ANDAs, 15 DMFs, 4 COS, 2 E-DMFs filed in FY2005 • Four NCE molecules in clinical stage • R&D spend in FY2005 – US$18 mm • Focused on US, EU, Australia, Japan, India, China and CIS • Share in Revenues from America & Europe increased from 10% in FY2001 to 24% in FY2005 • Employs 4,259 people • Home to 260 scientists Geographical Mix - FY2005 6
Product Profile - API & Intermediates • Proven process chemistry as well as fermentation skills • Major therapeutic focus areas: anti-TB, cephalosporins (both orals and injectables), prils and statins • Quality and cost leadership • Relationship Driven model Going Forward • Extending global dominance across a wider portfolio • Increasing strategic partnerships / alliances • Reap benefits of new and expanded capacities Amongst the top 2 globally in each area of focus 7
Product Profile - Finished Dosages US Specialty US Generics • Focus on $ 7 Bn pediatric market thru a dedicated sales force • Foundation laid with the launch of Suprax® - showing an increasing Rx trend • Co-promotion with Cornerstone BioPharma for Suprax® with focus on primary care physicians • Looking at justifiable brand acquisitions and in-licensing opportunities • Positioning to market other products from own NDDS platform • Fast building a pipeline of finished products for the US market • ~50 products in current pipeline with brand value of +$ 60 Bn • 7 ANDA approved till date, 15 pending approval • $756 mn Ceftriaxone launched in July 2005 with Baxter Healthcare and Henry Schein • API supply to Baxter Healthcare for Premix Frozen • 7 products planned for launch in FY 2006 • Target = +15 ANDA filings every year • Target = +25 product basket by FY 2008 Success Strategy: Focus generic opportunities in regulated markets 8
Product Profile - Finished Dosages India Other Markets • Portfolio of over 80 finished products with focus on anti-TB, anti-infectives, NSAIDS cardiovasculars and diabetes • 20 brands in the 'Top 3' of their respective product segments • Business growing at a rate of 9% as against 2% growth in the overall industry • 18 new products launched in 2005 including anti-Asthma • 1350 strong field force for marketing • Marketing divisions with specific therapeutic focus • Extending reach to access rural markets thru brand building • Fast building a pipeline of finished products for the other markets with strong R&D focus • Partnership business model in EU with own setup in select markets • +350 EOIs received till date • Plan to file 8-12 dossiers in FY 2006 • Entering Japanese generic market thru alliances • Co-operation agreement with Kyowa Pharma signed for multiple products • Consolidating presence in CIS market by introducing more products • Entering the Australian market with value added generics through alliances Success Strategy: Strong R&D focus with broad market specific product offering 9
Mandideep Ankleshwar Tarapur Aurangabad Pune Manufacturing Goa Research Center Globally Accredited Facilities 11
NDDS Process NCE ANDA Strong Research & Development Focus Process NDDS • Proven abilities in process chemistry and fermentation • Ability to develop products with high technology barriers • 30 DMF and 75 EDMFs filed • First licensing deal signed for anti-infective product • Three patented platforms for delivery systems • Two products launched in India ANDA NCE • 22 ANDAs filed,7 approved - including $756mn Ceftriaxone • Broad range of filings with wide therapeutic coverage • Anti-migraine and anti-psoriasis (herbal) in Phase IIa trials • Anti -tb and anti-psoriasis (chemical) in phase I trials • Anti-diabetes and anti-bacterial in pre-clinical stages 12
25.0 CAGR – 14.1% 280 271 268 22.7 260 22.0 19.4 240 19.0 214 17.6 220 Revenue (US$ MM) Net Income (US$ MM) 16.6 200 16.0 13.8 175 180 160 13.0 160 10.0 140 FY2001 FY2002 FY2003 FY2004 FY2005 6.0 2.5 5.4 5.3 2.0 5.0 1.8 2.0 1.7 4.0 1.5 Debt / Equity (x) 2.9 2.9 EBITDAa/ Interest (x) 3.0 2.3 0.9 0.8 1.0 2.0 0.5 1.0 - - FY2001 FY2002 FY2003 FY2004 FY2005 FY2001 FY2002 FY2003 FY2004 FY2005 Financial Profile Revenues Net Income FY2001 FY2002 FY2003 FY2004 FY2005 EBITDA / Interest Coverage Debt / Equity 14
Half Year Ended Sep 30 YOY (US$ Millions) 2004 2005 Growth Income Statement Data Revenue 141.1 178.3 26.4% EBITDA 17.0 34.3 101.8% EBIT 13.4 30.0 124.8% Interest 3.0 2.9 (2.9%) PBT 10.3 27.1 162.2% PAT 8.7 20.1 131.7% Key Ratios EBITDA Margins 12.6% 19.9% - PAT Margins 6.4% 11.7% - EBITDA/ Interest 5.6x 11.7x - Regulated Markets Driving Growth • Revenue increased by 26% • Export Revenue increased by 36% • Buoyant off-take in regulated market with sales increasing by 85% to US$38.9 mm • Finished dosage increased by 533% • API revenue increased by 15% • Profit margins improved substantially with reduction in costs Key Highlights 15
Business Strategy Continued growth of Anti-TB and Cephalosporin Business Strengthen Presence in Lifestyle Drugs Sustainable Growth Strong Corporate Governance Penetrate Regulated Markets Broad Basing the Product Basket ANDA, NDDS and NCE 16
Investment Highlights Leadership status in the global anti – TB and cephalosporin market Strong growth opportunity driven by Lupin’s entry into regulated markets which are supported by its strong DMF and ANDA pipeline US FDA/ EDQM/ Australian TGA compliant manufacturing facilities Increased focus on research programme including ANDA, NDDS and NCE providing multiple drivers of growth going forward Marketing tie-ups with global players 17