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 n Pharmaceutical Industry Overview n Lupin – A Differentiated Business Model n Financial Overview n Business Strategy and Investment Highlights 3
Pharmaceutical Industry Overview
Global Pharmaceutical Industry Overview u 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% Global Pharmaceutical Sales* 3. 7% CAGR – 1 u 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 Emerging Trends u Growing importance of generics in regulated markets · Pressure from healthcare providers and insurance companies to reduce Source: IMS World Review (Industry Sales based on Audited Numbers) Key Generic Drug Markets 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 u 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 4 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
Factors driving the Indian Pharmaceutical Industry Generic Exports and API Outsourcing Indian Pharmaceutical Market Overview exports accounting for an additional US$2. 5 bn · Amongst top 4 markets by volume globally u Strong branded generics market u 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% + u Introduction of product patents in India in 2005 are expected to lead to a greater emphasis on drug discovery and development 5 Growth Opportunities u Approximately US$5 bn in 2004 with India is well positioned to target generic exports and API outsourcing opportunities in the regulated markets u. Skilled work force with strong chemistry skills u. Significant and sustainable cost advantage over international peers u. 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 R&D Outsourcing u Skilled work force at competitive costs u Significant progress in development of pharma & R&D infrastructure over last 5 years u 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
Lupin – A Differentiated Business Model
Business Overview n Among the top 6 pharmaceutical companies in India · Leading global player in anti-TB & Cephalosporins · Therapeutic Mix - FY 2005 Strong position in prils and emerging global player in statins n Globally accredited manufacturing facilities n Strong R&D Focus · 14 ANDAs, 15 DMFs, 4 COS, 2 E-DMFs filed in FY 2005 · Four NCE molecules in clinical stage · R&D spend in FY 2005 – US$18 mm n Focused on US, EU, Australia, Japan, India, China and CIS · Share in Revenues from America & Europe increased from 10% in FY 2001 to 24% in FY 2005 n Employs 4, 259 people · 6 Home to 260 scientists Geographical Mix - FY 2005
Product Profile - API & Intermediates n Proven process chemistry as well as fermentation skills n Major therapeutic focus areas: anti-TB, cephalosporins (both orals and injectables), prils and statins n Quality and cost leadership Therapeutic Segment Global Rank Ethambutol Anti-TB 1 Rifampicin Anti-TB 1 Product n Relationship Driven model Pyrazinamide Going Forward 7 ACCA Cephalosporin Intermediate 2 7 ADCA Cephalosporin Intermediate 1 Lisinopril Cardiovascular 1 n Extending global dominance across a wider portfolio n Increasing strategic partnerships / alliances n Reap benefits of new and expanded capacities Anti-TB Amongst the top 2 globally in each area of focus 7 1
Product Profile - Finished Dosages US Specialty US Generics n Focus on $ 7 Bn pediatric market thru a dedicated sales force n Fast building a pipeline of finished products for the US market n Foundation laid with the launch of Suprax® showing an increasing Rx trend n ~50 products in current pipeline with brand value of +$ 60 Bn n Co-promotion with Cornerstone Bio. Pharma for Suprax® with focus on primary care physicians n 7 ANDA approved till date, 15 pending approval n Looking at justifiable brand acquisitions and inlicensing opportunities n $756 mn Ceftriaxone launched in July 2005 with Baxter Healthcare and Henry Schein n Positioning to market other products from own NDDS platform n API supply to Baxter Healthcare for Premix Frozen n 7 products planned for launch in FY 2006 n Target = +15 ANDA filings every year n Target = +25 product basket by FY 2008 8 Success Strategy: Focus generic opportunities in regulated markets
Product Profile - Finished Dosages India n 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 n Business growing at a rate of 9% as against 2% growth in the overall industry n 18 new products launched in 2005 including anti-Asthma n 1350 strong field force for marketing · · 9 Marketing divisions with specific therapeutic focus Extending reach to access rural markets thru brand building Other Markets n Fast building a pipeline of finished products for the other markets with strong R&D focus n 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 n Entering Japanese generic market thru alliances · Co-operation agreement with Kyowa Pharma signed for multiple products n Consolidating presence in CIS market by introducing more products n Entering the Australian market with value added generics through alliances Success Strategy: Strong R&D focus with broad market specific product offering
US / EU Product Development US EU ð Filings till date 22 - ð Approvals till date 7 - +15 8 -12 7 0 25 -30 8 -12 +15 6 -8 ð Target filings in FY 06 ð Target launches in FY 06 ð Products under development ð Target filings going forward per year 10
Globally Accredited Facilities LOCATION Rifampicin USFDA, UK MHRA Lovastatin - Ethambutol USFDA Gujarat Manufacturing USFDA Intermediates USFDA Aurangabad, Rifampicin WHO, MCC (South Africa) Maharashtra Pyazinamide WHO, MCC (South Africa) Lisinopril Goa Prils Ethambutol Pune USFDA, UK MHRA, TGA Ankleshwar, Aurangabad Cephalosporins Maharashtra Tarapur Mandideep, Tarapur, Ankleshwar APPROVALS Madhya Pradesh Mandideep PRODUCTS WHO, MCC (South Africa) Noncephalosporin Oral Formulations USFDA Verna, Goa Research Center Pune, Maharashtra 11 R&D
Strong Research & Development Focus Process NDDS u Proven abilities in process u First licensing deal signed for anti- chemistry and fermentation infective product u Ability to develop products with high u Three patented platforms for NDDS technology barriers u 30 DMF and 75 EDMFs filed Process ANDA delivery systems u Two products launched in India NCE ANDA u Anti-migraine and anti-psoriasis u 22 ANDAs filed, 7 approved - including $756 mn Ceftriaxone u Broad range of filings with wide therapeutic coverage 12 (herbal) in Phase IIa trials u Anti -tb and anti-psoriasis (chemical) in phase I trials u Anti-diabetes and anti-bacterial in pre-clinical stages
Experienced Management Team NAME POSITION BRIEF PROFILE Desh Bandhu Gupta, Ph. D Chairman n n Founded the company in 1968 Started his career teaching chemistry at Birla Institute of Science and Technology, Pilani, Rajashthan Kamal K Sharma, Ph. D Managing Director n Experience of more than three decades at a range of senior management positions managing projects, corporate development and general management in the pharmaceuticals and chemicals industries Satish Khanna Group President, API n n Strengthened Lupin's API business and secured the company's position among top manufacturers, globally Rich experience of more than 25 years in leading companies including Mitsu Industries, Tata Chemicals and Union Carbide Vinita Gupta Sharma President, Lupin Pharmaceuticals Inc, US n Has led Lupin's foray in the advanced markets of the US and Europe and in cementing alliances with global majors Himadri Sen, Ph. D President, Pharma research n n Spearheading Lupin's drive for NDDS, ANDA and patent fillings Has worked with leading Indian and global pharma companies in the areas of pharma research, technology development and transfer and manufacturing support Shakti Chakraborty President, India Region Formulations n n Has driven Lupin's entry in the lifestyle segments Experience of more than three decades with leading pharmaceutical companies like Wockhardt, Aristo Pharma Vinod Dhawan President--Business Development n n Heads the AAMLA region, responsible for the development of Lupin’s business strategy for these markets. Has worked with Ranbaxy in their international business Divakar Kaza President, Human Resources n n Responsible for developing HR management strategy and align it with overall business strategy of the company Brings along with him rich business experience of about 2 decades in organizations like Wipro, General Electric etc Indrajit Banerjee President, Finance & Planning n n Responsible for the finance, IT and planning functions and align it with overall business strategy of the company Rich experience of more than 2 decades in organizations like Indal, Lucent Technologies Harish Narula President Corporate Affairs n Heads the company’s business initiatives in the CIS region Supports the businesses through various Embassies and trade Associations Nilesh Gupta Exec VP, IPMG 13 n n Responsible for driving product identification for the advanced markets identifying in-licensing and out-licensing opportunities
Financial Overview
Financial Profile Revenues – AGR % 14. 1 268 C 260 240 214 220 200 180 25. 0 271 Net Income (US$ MM) Revenue (US$ MM) 280 Net Income 175 160 22. 7 22. 0 19. 4 19. 0 16. 6 13. 8 13. 0 10. 0 140 FY 2001 FY 2002 FY 2003 FY 2004 FY 2001 FY 2005 EBITDA / Interest Coverage 5. 4 4. 0 2. 9 2. 3 2. 0 FY 2004 FY 2005 1. 8 2. 0 1. 7 1. 5 0. 8 1. 0 0. 9 FY 2004 FY 2005 0. 5 - FY 2001 14 FY 2003 2. 5 5. 3 5. 0 2. 9 FY 2002 Debt / Equity (x) EBITDAa/ Interest (x) 6. 0 3. 0 17. 6 FY 2002 FY 2003 FY 2004 FY 2005 FY 2001 FY 2002 FY 2003
Regulated Markets Driving Growth Half Year Ended Sep 30 YOY Key Highlights (US$ Millions) 2004 2005 Growth Income Statement Data n Revenue increased by 26% · Export Revenue increased by 36% 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% · Finished dosage increased by 533% PAT 8. 7 20. 1 131. 7% · API revenue increased by 15% Key Ratios EBITDA Margins 19. 9% - PAT Margins 6. 4% 11. 7% - EBITDA/ Interest 15 12. 6% 5. 6 x 11. 7 x - n Buoyant off-take in regulated market with sales increasing by 85% to US$38. 9 mm n Profit margins improved substantially with reduction in costs
Business Strategy and Investment Highlights
Business Strategy Continued growth of Anti-TB and Cephalosporin Business Strong Corporate Governance Broad Basing the Product Basket 16 Strengthen Presence in Lifestyle Drugs Sustainable Growth Penetrate Regulated Markets ANDA, NDDS and NCE
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
Thank You
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