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Presentation on theme: "Investor Presentation"— Presentation transcript:

1 Investor Presentation
November 2005 1

2 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

3 Agenda Pharmaceutical Industry Overview
Lupin – A Differentiated Business Model Financial Overview Business Strategy and Investment Highlights 3

4 Pharmaceutical Industry Overview

5 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* CAGR – 13.7% 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

6 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

7 Lupin – A Differentiated Business Model

8 Business Overview 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 Therapeutic Mix - FY 2005 Geographical Mix - FY2005 6

9 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 Product Therapeutic Segment Global Rank Ethambutol Anti-TB 1 Rifampicin Pyrazinamide 7ACCA Cephalosporin - Intermediate 2 7ADCA Lisinopril Cardiovascular Amongst the top 2 globally in each area of focus 7

10 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

11 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

12 US / EU Product Development
Filings till date 22 - Approvals till date 7 Target filings in FY06 +15 8-12 Target launches in FY06 Products under development 25-30 Target filings going forward per year 6-8 10

13 Globally Accredited Facilities
LOCATION PRODUCTS APPROVALS Mandideep, Madhya Pradesh Cephalosporins Prils USFDA, UK MHRA, TGA USFDA Tarapur, Maharashtra Rifampicin Lovastatin USFDA, UK MHRA - Ankleshwar, Gujarat Ethambutol Intermediates Aurangabad, Pyazinamide Lisinopril WHO, MCC (South Africa) Verna, Goa Non-cephalosporin Oral Formulations Pune, Maharashtra R&D Ankleshwar Mandideep Tarapur Pune Aurangabad Goa Manufacturing Research Center 11

14 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 Process ANDA NCE NDDS 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

15 Experienced Management Team
NAME POSITION BRIEF PROFILE Desh Bandhu Gupta, Ph.D Chairman 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 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 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 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 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 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 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 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 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 Heads the company’s business initiatives in the CIS region Supports the businesses through various Embassies and trade Associations Nilesh Gupta Exec VP, IPMG Responsible for driving product identification for the advanced markets identifying in-licensing and out-licensing opportunities 13

16 Financial Overview

17 EBITDA / Interest Coverage
Financial Profile Revenues Net Income 160 175 214 268 271 140 180 200 220 240 260 280 Revenue (US$ MM) CAGR – 14.1% 13.8 16.6 17.6 22.7 19.4 10.0 13.0 16.0 19.0 22.0 25.0 FY2001 FY2002 FY2003 FY2004 FY2005 Net Income (US$ MM) FY2001 FY2002 FY2003 FY2004 FY2005 EBITDA / Interest Coverage Debt / Equity 2.3 2.9 5.4 5.3 - 1.0 2.0 3.0 4.0 5.0 6.0 FY2001 FY2002 FY2003 FY2004 FY2005 EBITDAa/ Interest (x) 1.8 2.0 1.7 0.8 0.9 - 0.5 1.0 1.5 2.5 FY2001 FY2002 FY2003 FY2004 FY2005 Debt / Equity (x) 14

18 Regulated Markets Driving Growth
Half Year Ended Sep 30 YOY 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 (US$ Millions) Key Highlights 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 15

19 Business Strategy and Investment Highlights

20 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

21 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

22 Thank You


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